JP6717757B2 - Tissue closure device and method - Google Patents

Description

CROSS REFERENCE TO RELATED APPLICATIONS This application claims priority to US patent application Ser. No. 14/301,106 filed June 10, 2014. US patent application Ser. No. 14/301,106 is a continuation of US patent application Ser. No. 13/843,930, filed Mar. 15, 2013, with the benefit of that filing date. Insist. US patent application Ser. No. 13/843,930 is a partial continuation of US patent application Ser. No. 13/010,769 filed Jan. 20, 2011, the benefit of which is hereby filed. Insist. U.S. Patent Application No. 13/010,769 was filed on Jan. 20, 2010, US Provisional Patent Application No. 61/296,868, filed on Jan. 20, 2011. US patent application Ser. No. 13/010,766, US patent application Ser. No. 13/010,777 filed Jan. 20, 2011, and US filed Jan. 20, 2011 Claim the benefit of patent application Ser. No. 13/010,774. U.S. Patent Application No. 14/301,106 is also a continuation of and claims the priority of International Application PCT/US14/30868 filed March 17, 2014. International application PCT/US14/30868 claims priority to US patent application Ser. No. 13/843,930 filed March 15, 2013.

In addition, the following: US patent application Ser. No. 14/301,106 filed June 10, 2014, US patent application Ser. No. 13/843, filed March 15, 2013. No. 930, International application PCT/US14/30868 filed on Mar. 17, 2014, US patent application No. 13/010,769 filed on Jan. 20, 2011 , U.S. Provisional Patent Application No. 61/296,868 filed on Jan. 20, 2011, U.S. Patent Application No. 13/010,766 filed on Jan. 20, 2011, U.S. Patent Application No. 13/010,777 filed Jan. 20, 2011 and U.S. Patent Application No. 13/010,774 filed Jan. 20, 2011, The contents of each are incorporated herein by reference in their entireties.

The present invention relates to tissue closure devices and methods.

Surgical intervention requires access to a visceral surgical site with an injury and/or disease. This involves puncturing or incising a healthy tissue layer to form an opening for access. For example, during a thoracotomy procedure, the surgeon may make an incision in the skin between the ribs and thus puncture one or more layers of tissue with a trocar, scalpel, or other sharp device to cannulate or retractor. Typically allows the insertion of the to maintain the opening in the tissue. The surgical site can be accessed by inserting a surgical instrument through the cannula or retractor. For example, the surgeon and/or the interventionist will have access to the diseased or damaged aortic valve by performing a thoracotomy and myotomy through the apex. This procedure requires the surgeon to access the myocardium of the patient's heart, for example by making a small intercostal incision in the patient's chest. Such procedures further maintain the desired diameter of the access opening by incising the myocardium of the heart to form the access opening and inserting a sheath introducer, followed by sheathing catheters and other devices. It involves protecting the heart tissue during insertion and/or removal through. Catheter and other devices can then be inserted through the cannula into one or more chambers of the heart to repair the defective or damaged portion of the heart.

In addition, some pericardiocentesis procedures involve inserting a needle into the pericardium through the patient's intercostal opening, guiding a flexible guidewire through the needle, and then leaving the guidewire in place. This involves removing the needle. After removing the needle, a tapered dilator can be advanced over the guidewire to expand the opening in the pericardial tissue. The expanded opening, or tube, provides room for the catheter. After dilation, fluid is drained from the pericardium by guiding the catheter over a guide wire into the pericardium.

Transpericardial or transapical access to the myocardium is generally less invasive than the more traditional surgical modalities because the required portal or opening is generally relatively small. However, such small openings can be difficult to close, especially because the closed position is inside the patient's body. For example, with reference to the procedure above, after removal of the sheath introducer and any catheters or other devices extending through the sheath introducer, the opening formed in the tissue, such as heart or pericardial tissue, closes within the patient. To be Since these exemplary procedures involve accessing the patient's chest cavity through small intercostal openings through the patient's skin and other underlying tissues (eg, fat and/or fascia), closure methods such as suturing are traditional. More complex than with traditional open surgical procedures. Specifically, attaching sutures to a closed position within the patient's body through a small opening, such as mini-thoracotomy, is more difficult and complex than the direct manual manipulation of a suture needle at an open surgical site. .. Such difficulties can result in poor closure and/or closure requiring more time than is required.

Poor closure may expose the patient to increased risk of complications such as internal bleeding and/or infection. Even if the mal-occlusion is recognized and addressed before the surgical procedure is complete, correction of the mal-occlusion may increase the time required to affect the closure and expose the tissue to additional wounds. It is generally desirable to minimize surgical procedure time to reduce the potential for complications and unnecessary injury to the patient.

Therefore, there is a need for closure mechanisms and methods that are easy to operate, reliable, and have a short turnaround time to form an effective closure.

According to a preferred embodiment of the invention, the device comprises a plurality of anchors, at least one elastic closure element coupled to the anchors and formed to propel the anchors towards each other, and A driver configured to drive the anchor and push it into the tissue while coupled to the anchor, the closure element for closing the opening in the tissue disposed between the anchors pushed into the tissue. It has sufficient resilience to propel the anchors pushed into the tissue in a direction toward one another and to resist the opposing forces exerted on the anchors that propel the anchors away from one another.

The counter force may be applied to the anchor by at least one of (a) tissue, (b) fluid flow, (c) air pressure, (d) hydraulic pressure, and (e) external force.

The device further includes a safety release mechanism including a plurality of spring loaded members, each spring loaded member being independently movable between an engaged position and an engaged disengaged position, the safety release mechanism comprising: It is configured to prevent the driver from driving the anchor unless all of the members are in the engaged position.

The anchors may each include an elongate body having a distal tip configured to pierce the tissue as each anchor is driven distally and pushed into the tissue.

The anchors may each include anchoring prongs configured to resist proximal movement of the anchor after the anchor has been driven into the tissue.

The anchoring protrusion may be a wing, which may extend proximally and radially in a radial direction from a connection between the wing and the elongated body to a free end.

The airfoil may include a plurality of proximally extending cutting protrusions at the free end of the airfoil.

The wings may be formed by cuts that extend radially inward and distally into the elongated body.

The elongate body and airfoil may include a plurality of longitudinally extending folds that provide a plurality of proximally extending cutting protrusions at the free end of the airfoil.

The anchors may each include first and second anchoring prongs configured to resist proximal movement of the anchor after the anchor is driven into the tissue. The second securing protrusions are arranged at respective positions offset from each other along the length of the elongated body.

The first and second anchoring protrusions may be first and second wings formed by first and second cuts, respectively, that extend radially inwardly and distally into the elongated body, The first and second cuts terminate at respective positions offset from each other along the length of the elongated body.

The closure element may include at least one of a band, an elastomeric band, and a band made of silicone.

The anchors may each include a hook-shaped protrusion configured to receive the band.

The hook-shaped protrusion may be configured to maintain engagement between the band and the anchor by preventing the band from moving away from the proximal end of the anchor.

The device may include a plurality of closure elements.

Each of the plurality of closure elements may contact two or more of the anchors.

The closure element may form two overlapping V-shaped patterns.

The plurality of closure elements may contact three or more of the anchors.

At least one closure element may include an integral V-shaped element that couples three of the anchors.

The device may include two integral V-shaped closure elements each formed to contact three of the anchors. The two V-shaped closing elements may overlap so as to form a diamond-shaped operating window.

The device may further include a centering element configured to receive the guidewire. The centering element may be a tubular shaft.

The anchors may be arranged along the ring-shaped circumference in the first configuration.

The closure element may be prevented from extending inside the ring-shaped circumference by one or more tubes.

The driver may be configured to drive multiple anchors simultaneously.

The driver may include a spring loaded element configured to impact the anchor and impart a distally directed momentum to the anchor.

The device may further include a trigger configured to release the spring loaded element from the preloaded position for driving the plurality of anchors.

The device may further include a handle, the trigger being located within the handle.

The handle, trigger, and driver may be removable from the cannula, outer working tube, anchors, and closure element.

The plurality of anchors and closure elements may be formed of bioabsorbable material.

According to a preferred embodiment of the invention, the device comprises a plurality of anchors and at least one elastic closure element which is coupled to the anchors and is configured to propel the anchors towards each other. The elements are sufficient to propel the anchors pushed into the tissue toward each other and to close the anchors away from each other to close the tissue opening located between the anchors pushed into the tissue. It has sufficient elasticity to resist the counterforce exerted on the anchor.

The counter force may be applied to the anchor by at least one of (a) tissue, (b) fluid flow, (c) air pressure, (d) hydraulic pressure, and (e) external force.

According to a preferred embodiment of the present invention, the method is sufficient for implanting a plurality of anchors into tissue, and (a) sufficient to close an opening in tissue disposed between the implanted anchors, and (b ) By means of at least one elastic closure element coupled to the anchor by a force sufficient to resist the counterforce exerted on the implanted anchor that pushes the anchors away from each other and in the direction of opening the opening. Propulsing the embedded anchors towards each other.

The counter force may be applied to the anchor by at least one of (a) tissue, (b) fluid flow, (c) air pressure, (d) hydraulic pressure, and (e) external force.

According to a preferred embodiment of the invention, the method comprises implanting a plurality of anchors in tissue, propelling the implanted anchors towards each other by at least one elastic closure element coupled to the anchors. Forming an opening in the tissue between the implanted anchors, the elastic closure element being (a) sufficient to maintain the tissue opening in the closed position and (b) separating the anchors. Propelling the implanted anchors toward each other and towards the opening with sufficient force to resist the opposing forces exerted on the implanted anchors that propel the opening toward the opening, inserting the device through the opening And (b) after removal of the device from the opening, (a) an implanted anchor that is sufficient to maintain the opening of the tissue in a closed position and (b) separates the anchor and propels it in the direction of opening the opening. Urging the implanted anchors toward each other and towards the opening by an elastic closure element having a force sufficient to resist the opposing force applied to the anchors.

The counter force may be applied to the anchor by at least one of (a) tissue, (b) fluid flow, (c) air pressure, (d) hydraulic pressure, and (e) external force.

According to a preferred embodiment of the invention, the method comprises forming an opening in the tissue, inserting a centering device through the opening, and using the centering device to center the anchor around the opening in the tissue. Implanting a plurality of anchors, propelling the implanted anchors toward each other and towards the opening by at least one elastic closure element coupled to the anchor, inserting the device through the opening, and opening After removal of the device from (a) is again applied to the implanted anchor that (a) is sufficient to maintain the tissue opening in the closed position and (b) disengages the anchor and propels the opening in the forward direction. Propulsing the implanted anchors toward each other and towards the opening by an elastic closure element having sufficient force to resist the opposing forces.

The counter force may be applied to the anchor by at least one of (a) tissue, (b) fluid flow, (c) air pressure, (d) hydraulic pressure, and (e) external force.

According to a preferred embodiment of the present invention, a surgical device comprises two or more anchors, a driver configured to drive the anchors into the tissue, and at least one elastic extending between the anchors. An elastic closure element, the elastic closure element comprising: a first configuration in which the anchors are located at a first distance from each other; and a second distance in which the anchors are located at a second distance that is less than the first distance. The surgical device is configured to propel the anchor towards a second configuration located relative to each other, the surgical device maintaining the driven anchor in the first configuration, and the anchor by the at least one closure element to the second configuration. It is configured to selectively release a driven anchor to allow it to be moved toward the configuration.

The anchors may each include an elongate body having a distal tip configured to pierce the tissue as each anchor is driven distally and pushed into the tissue.

The anchors may each include anchoring prongs configured to resist proximal movement of the anchor after the anchor has been driven into the tissue.

The anchoring protrusion may be a wing, which may extend proximally and radially in a radial direction from a connection between the wing and the elongated body to a free end.

The airfoil may include a plurality of proximally extending cutting protrusions at the free end of the airfoil.

The wings may be formed by cuts that extend radially inward and distally into the elongated body.

The elongate body and airfoil may include a plurality of longitudinally extending folds that provide a plurality of proximally extending cutting protrusions at the free end of the airfoil.

The anchors may each include first and second anchoring prongs configured to resist proximal movement of the anchor after the anchor is driven into the tissue. The second securing protrusions are arranged at respective positions offset from each other along the length of the elongated body.

The first and second anchoring protrusions may be first and second wings formed by first and second cuts, respectively, that extend radially inwardly and distally into the elongated body, The first and second cuts terminate at respective positions offset from each other along the length of the elongated body.

The closure element may be a band. The band may form a continuous loop. The band may be elastomeric. The band may be formed of silicon.

The anchors may each include a hook-shaped protrusion configured to receive the band.

The hook-shaped protrusion may be configured to maintain engagement between the band and the anchor by preventing the band from moving away from the proximal end of the anchor.

The device may include two or more closure elements. Each of the plurality of closure elements may contact only two of the anchors. For example, two or more closure elements may include four closure elements, or may include six anchors, two of the six anchors only on two of the four closure elements. Are coupled, and four of the six anchors are each coupled to only one of the four closure elements. The closure element may form two overlapping V-shaped patterns.

The plurality of surgical closure elements may contact three or more of the anchors.

The at least one closure element may include an integral V-shaped element formed to contact three of the anchors.

The at least one closure element may include two or more integral V-shaped closure elements each formed to contact three of the anchors. For example, the V-shaped elements may overlap to form a diamond shaped window.

The device may further include a centering element configured to receive the guidewire. 26. The device of claim 25, wherein the centering element is a tubular shaft. The centering element may have a proximal portion formed to allow the centering mechanism to be retracted from the rest of the surgical device.

The device may further include at least one pressure sensor configured to indicate whether the device is in sufficient contact with tissue prior to driving the anchor.

The at least one pressure sensor may include at least one contact element extending distally from the distal end of the device. The at least one contact element may be adapted to be depressed when the distal end of the device is pressed against tissue.

The apparatus may further include a key plate and at least one key member, the at least one key member having a first position in which the at least one key member is engaged with the key plate and the at least one key member. Has a key plate and a second position disengaged, and depression of the contact element moves at least one key member from the first position to the second position.

The key plate may prevent actuation of the anchor when at least one key member is engaged with the key plate.

At least one key member includes a plurality of key members, each key member being independently moveable by a respective contact element. The key plate may prevent actuation of the anchor if any one of the key members is engaged with the key plate.

The anchors may be arranged along the ring-shaped circumference in the first configuration.

The closure element may be prevented from extending within the ring-shaped perimeter when the anchor is maintained in the first configuration.

The surgical device may further include a cannula configured to provide access to a surgical site located between the anchors when the anchors are maintained in the first configuration.

The cannula may be shaped to maintain the anchor in the first configuration.

The anchor and closure element may be located radially outwardly of the cannula.

The surgical device may further include an outer working tube with a cannula extending within the outer working tube.

At least one of the cannula and the outer working tube may have an outer surface configured to prevent the anchor and closure element from extending to any radial position corresponding to the interior of the cannula.

The surgical device may include a plurality of closure elements that are prevented from extending to any radial position corresponding to the inner channel of the cannula.

The cannula may include a distal portion having a flanged orientation, wherein in the flanged orientation the distal portion is formed to prevent movement of the closure element distally beyond the distal end of the cannula. Forming a radially extending flange. The flange may extend radially beyond the outer surface of the outer working tube.

The distal portion of the cannula may be adapted to be actuated to a second orientation, wherein in the second orientation the distal portion of the inner working channel is distal to the closure element beyond the distal end of the cannula. It does not prevent you from moving to.

The flange may extend distally when the distal portion of the cannula is in the second orientation.

The distal portion of the cannula may be adapted to be actuated from the flanged orientation to the second orientation by sliding the cannula proximally with respect to the outer working tube.

The depth to which the anchor is driven by the driver may be limited by the contact between the closure element and the radially extending flange.

The driver may be configured to drive multiple anchors simultaneously.

The driver may include a spring loaded element configured to impact the anchor and impart a distally directed momentum to the anchor.

The surgical device may further include a trigger configured to release the spring loaded element from the preloaded position to drive the plurality of anchors.

The surgical device may further include a handle, with a trigger disposed within the handle.

The surgical device may further include a safety element, the safety element being configured to prevent the trigger from releasing the spring loaded element when in the safe position.

The handle, trigger, and driver may be removable from the cannula, outer working tube, anchors, and closure element.

The plurality of anchors and closure elements may be formed of bioabsorbable material.

According to a preferred embodiment of the invention, the method comprises implanting two or more anchors into the tissue, placing the embedded anchors in a first configuration in which the anchors are at a first distance from each other. Maintaining, propelling the anchors from the first configuration towards a second configuration in which the anchors are located at a second distance less than the first distance from each other, between two or more anchors Forming an opening in the tissue in the region and contracting the opening by allowing the anchor to move from the first configuration to the second configuration.

The opening may be formed while the embedded anchor is maintained in the first configuration.

The opening may be formed using a trocar, scalpel, or other sharpened device, and expanded using a dilator, sheath introducer, or catheter.

The method may further include performing thoracoscopic surgery through the opening.

The closure element may include a cannula or sheath introducer configured to maintain the closure device in a preloaded state, and the surgical procedure is performed through the cannula or sheath introducer.

The tissue may be blood vessel or heart tissue.

The surgical procedure may be transapical valve replacement or repair.

In accordance with a preferred embodiment of the present invention, a surgical device comprises a plurality of anchors configured to be driven and pushed into tissue and at least one elastic closure element extending between the anchors. , The elastic closure element is from a first configuration in which the anchors are located at a first distance from each other to a second configuration in which the anchors are located at a second distance that is less than the first distance Formed to propel the anchor, the surgical device is adapted to maintain the anchor in the first configuration during a surgical procedure and subsequently the anchor is moved toward the second configuration by the closure element. Is formed to enable the

In accordance with a preferred embodiment of the present invention, a surgical device comprises a driver configured to drive a plurality of anchors into a tissue in a first configuration in which the anchors are located a first distance from each other. The device is configured to maintain the driven anchors in the first anchor configuration and toward the second configuration in which the anchors are closer together than when the anchors are in the first anchor configuration. It is configured to selectively release a driven anchor to allow it to be moved by the closure element.

The driver may be configured to drive each anchor by, for example, a) impacting each anchor or b) impacting a pin configured to transfer momentum from the driver to the anchor.

The driver may be configured to be actuated from a proximal position to a distal position. In the distal position, the driver may impart momentum to each anchor by either a) impacting each anchor or b) impacting a pin configured to transfer momentum from the driver to the anchors. .. The driver may be configured to be spring actuated.

In accordance with a preferred embodiment of the present invention, a device is coupled to a plurality of anchors and at least one tissue compression band coupled to the anchors configured to propel the anchors toward one another. And a driver configured to drive the anchor with the tissue compression band to push the anchor into the tissue, the tissue compression band to close an opening in the tissue located between the anchors pushed into the tissue. It has sufficient resilience to propel the anchors pushed into the tissue towards each other.

The force may be applied to the anchor by at least one of (a) tissue, (b) fluid flow, (c) air pressure, (d) hydraulic pressure, and (e) external force.

The anchors may each include a distal tip configured to pierce the tissue as each anchor is driven distally and pushed into the tissue.

The anchors may each include anchoring prongs configured to resist proximal movement of the anchor after the anchor has been driven into the tissue.

The anchoring protrusion may be a wing, which may extend proximally and radially radially from the proximal end of the distal tip to the free end.

The airfoil may include a plurality of proximally extending cutting protrusions at the free end of the airfoil.

The wing may include a plurality of longitudinally extending folds, the fold providing a plurality of proximally extending cutting protrusions at the free end of the wing.

The tissue compression band may include at least one of a band, an elastomeric band, and a band composed of silicone.

The tissue compression band may include first and second ends, each of the first and second ends having at least one protrusion extending radially from the end, and Each of the plurality of anchors comprises a coupling element.

The coupling element may be configured to maintain engagement of the tissue compression band with the anchor by preventing the band from separating from the anchor.

The device may include multiple tissue compression bands.

Each of the tissue compression bands may contact two or more of the anchors.

Each of the tissue compression bands may contact two anchors.

Tissue compression bands may overlap with other tissue compression bands.

The four tissue compression bands may overlap to form a square.

The four tissue compression bands may overlap to form a diamond.

The anchors may be arranged along the ring-shaped circumference in the first configuration.

The anchors may be arranged in a square shape in the first form.

The driver may be configured to drive multiple anchors simultaneously.

The driver may be configured to drive the anchor a predetermined distance.

The driver may include a spring loaded element configured to impact the anchor and impart a distally directed momentum to the anchor.

A trigger may be formed to release the spring loaded element from the preloaded position to drive the plurality of anchors.

The trigger may be located within the handle.

The plurality of anchors and tissue compression bands may be formed of bioabsorbable material.

The tissue compression band may have a relaxed state, in which the tissue compression band does one of (i) not apply force to the anchor and (ii) apply minimal force. , Under tension, the tissue compression bands exert a force that propels the anchors toward each other.

The tissue compression band may be in a relaxed state before being driven by the driver and pushed into the tissue.

The tissue compression band may be in tension after being driven into the tissue by the driver.

The tissue compression band may be coupled to the anchor at a point located within the tissue after the anchor has been driven by the driver and pushed into the tissue.

In accordance with a preferred embodiment of the present invention, the device comprises a plurality of anchors and at least one tissue compression band coupled to the anchors configured to propel the anchors toward one another. The compression band is sufficiently elastic to propel anchors pushed into tissue toward one another to close an opening in tissue located between anchors pushed into tissue.

According to a preferred embodiment of the present invention, a method comprises coupling a plurality of anchors into a tissue and coupling the anchors with sufficient force to close an opening in the tissue located between the implanted anchors. Urging the implanted anchors toward one another by at least one tissue compression band provided.

According to a preferred embodiment of the present invention, a device is configured to drive a plurality of anchors, a closure plate coupled to the anchor, and a closure plate coupled to the anchor to drive the anchor into tissue. And a closure plate coupled to the anchor and configured to close an opening in tissue disposed between the anchors pushed into the tissue.

The closure plate may be rigid.

The closure plates may be configured to propel the anchors toward each other.

The anchors may each include an elongate body having a distal tip configured to pierce the tissue as each anchor is driven distally and pushed into the tissue.

The anchors may each include anchoring prongs configured to resist proximal movement of the anchor after the anchor has been driven into the tissue.

The anchoring protrusion may be a wing, which may extend proximally and radially in a radial direction from a connection between the wing and the elongated body to a free end.

The airfoil may include a plurality of proximally extending cutting protrusions at the free end of the airfoil.

The wings may be formed by cuts that extend radially inward and distally into the elongated body.

The elongate body and airfoil may include a plurality of longitudinally extending folds that provide a plurality of proximally extending cutting protrusions at the free end of the airfoil.

The anchors may each include first and second anchoring prongs configured to resist proximal movement of the anchor after the anchor is driven into the tissue. The second securing protrusions are arranged at respective positions offset from each other along the length of the elongated body.

The first and second anchoring protrusions may be first and second wings formed by first and second cuts, respectively, that extend radially inwardly and distally into the elongated body, The first and second cuts terminate at respective positions offset from each other along the length of the elongated body.

The closure element may be sufficiently elastic to propel the anchors pushed into the tissue towards each other to close the tissue opening located between the anchors pushed into the tissue.

The closure element may include at least one of a band, an elastomeric band, and a band made of silicone.

The anchors may each include a hook-shaped protrusion configured to receive the band.

The hook-shaped protrusion may be configured to maintain engagement between the band and the anchor by preventing the band from moving away from the proximal end of the anchor.

The closure plate may be circular.

The closure plate may be square.

The closure plate may include a plurality of sliding braces.

The driver may be configured to drive multiple anchors simultaneously.

The driver may be configured to drive the anchor a predetermined distance.

The driver may include a spring loaded element configured to impact the anchor and impart a distally directed momentum to the anchor.

A trigger may be formed to release the spring loaded element from the preloaded position to drive the plurality of anchors.

The trigger may be located within the handle.

The plurality of anchors and closure plates may be formed of bioabsorbable material.

According to a preferred embodiment of the present invention, the device comprises a plurality of anchors and a closure plate coupled to the anchors, the anchors and the closure plate coupled between the anchors being pushed into the tissue. It is shaped to close the opening of the placed tissue.

According to a preferred embodiment of the invention, the method comprises implanting a plurality of anchors into the tissue and closing an opening in the tissue located between the anchors pushed into the tissue.

In accordance with a preferred embodiment of the present invention, a device is coupled to a plurality of anchors, at least one closure element coupled to the anchors, the closure element formed to propel the anchors toward one another, A closure element for driving the anchor into the tissue to drive the anchor into the tissue, the closure element into the tissue to close an opening in the tissue located between the anchors pushed into the tissue. It has sufficient resilience to propel the pushed anchors towards each other.

The force may be applied to the anchor by at least one of (a) tissue, (b) fluid flow, (c) air pressure, (d) hydraulic pressure, (e) external force, and (f) hand pressure. ..

The anchors may each include a distal tip configured to pierce the tissue as each anchor is driven distally and pushed into the tissue.

The anchors may each include anchoring prongs configured to resist proximal movement of the anchor after the anchor has been driven into the tissue.

The anchoring protrusion may be a wing, which may extend proximally and radially radially from the proximal end of the distal tip to the free end.

The airfoil may include a plurality of proximally extending cutting protrusions at the free end of the airfoil.

The wing may include a plurality of longitudinally extending folds, the fold providing a plurality of proximally extending cutting protrusions at the free end of the wing.

The closure element may include at least one of a band, a tissue compression band, an elastomeric band, and a band composed of silicone.

The closure element may include first and second ends, each of the first and second ends having at least one projection extending radially from the end, and further comprising a plurality of Each of the anchors has a coupling element.

The coupling element may be configured to maintain engagement of the closure element with the anchor by preventing the band from separating from the anchor.

The device may include a plurality of closure elements.

Each of the closure elements may contact two or more of the anchors.

Each of the closure elements may contact two anchors.

The driver may be tubular, and each of the closure elements is wrapped around the tubular driver.

The tubular driver may comprise at least one push pin configured to retain the closure element around the tubular driver in the winding position.

A tubular outer sheath may be annularly arranged around the wrapped closure element.

An outer sheath may be configured to slide proximally to expose the wrapped closure element.

The driver may be further configured to drive the anchor radially outward.

According to a preferred embodiment of the invention, the method comprises inserting a surgical device having at least one closure element coupled to a plurality of anchors wrapped around a tubular device into a tissue opening. Removing the outer sheath from an annular position around the wrapped closure element, driving an anchor coupled to the closure element into the tissue from below the surface of the tissue, and removing the surgical device from the tissue. , The anchor and the closure element remain within the tissue.

In accordance with a preferred embodiment of the present invention, a surgical anchor has a distal end tapered toward a distal tip formed to pierce tissue and a flexible extension extending proximally from the distal end. And at least one airfoil extending from a distal end proximally and radially outward to a free end, the element including a radially outer surface and a radially inner surface. Surface includes a longitudinally extending fold, the fold providing a plurality of proximally extending protrusions at the free end.

The force may be applied to the anchor by at least one of (a) tissue, (b) fluid flow, (c) air pressure, (d) hydraulic pressure, and (e) external force.

The radially inner surface may be concave.

The flexible element may be configured to flex in cooperation with a force applied to the anchor.

The wings may be configured to resist proximal movement of the anchor after the anchor has been driven and pushed into the tissue. The airfoil further extends to the free end and may include a plurality of proximally extending cutting protrusions at the free end. The folds provide a plurality of proximally extending cutting prongs at the free end of the wing.

The anchors may be arranged in a form having a plurality of anchors along a ring-shaped circumference. The anchors may be arranged in a rectangular shape having a plurality of anchors. The anchor may be formed of a bioabsorbable material.

In accordance with a preferred embodiment of the present invention, a surgical anchor has a distal end tapered towards a distal tip formed to pierce tissue, a radially outer surface and a radially inner surface. At least one wing extending proximally and radially outwardly from the distal end to the free end, the radially outer surface including a fold extending longitudinally, the fold being proximal. Providing a plurality of protrusions at the free end.

In accordance with a preferred embodiment of the present invention, a surgical device comprises an anchor, a distal end tapering toward a distal tip formed to pierce tissue, and a distal end from the distal end. At least one wing extending proximally and radially outwardly to the free end and extending from the distal end at the shoulder of the anchor; and a flexible element extending proximally from the distal end. And the shoulder is located at or at the intersection of the flexible element and the distal portion of the airfoil, and the anchor and the anchor that drives the anchor within the tissue. A driver configured to apply a driving force to the shoulder of the anchor for pushing into the anchor, the airfoil including a radially outer surface and a radially inner surface, the radially outer surface being longitudinal. A fold that extends in a direction, the fold providing a plurality of proximally extending protrusions at the free end.

The anchors may be arranged in a configuration with multiple anchors and the driver may be configured to drive the anchors at the same time or drive the anchors a predetermined distance. The driver may comprise a spring loaded element configured to impact the anchor and impart distally directed momentum to the anchor.

The wing may extend proximally beyond the shoulder and the driver includes a pin in contact with the shoulder of the anchor, the pin configured to drive the anchor distally and force it into the tissue. There is.

In accordance with a preferred embodiment of the present invention, a surgical device includes a distal end tapered toward a distal tip formed to pierce tissue, and proximally and radially outwardly from the distal end. A surgical anchor including at least one wing extending toward a free end, at least one window formed to allow the wing to expand to a relaxed position, and the wing to a compressed position A delivery mechanism having a distal end including at least one constriction element formed to compress, the airfoil including a radially outer surface and a radially inner surface, and a radially outer surface. The surface of the window includes a longitudinally extending fold, the fold providing a plurality of proximally extending projections at the free end, such that the wing is positioned in a relaxed position before the delivery mechanism ejects the anchor. Located within the wing, the wing faces the constriction element such that the wing narrows from the relaxed position to the compressed position while the delivery mechanism ejects the anchor, and the wing relaxes once ejected from the delivery mechanism. It is formed so as to return to the position.

In accordance with a preferred embodiment of the present invention, a surgical anchor has a distal end tapered toward a distal tip formed to pierce tissue and a flexible extension extending proximally from the distal end. A stem, and at least one hook extending from the distal end proximally and radially outward to the free end, including a radially outer surface and a radially inner surface. The outer surface includes a longitudinally extending fold, the fold providing a plurality of proximally extending protrusions at the free end, and a flexible stem that is flexible relative to the at least one barb and distal tip. It is flexible. The radially inner surface may be concave.

The force may be applied to the anchor by at least one of (a) tissue, (b) fluid flow, (c) air pressure, (d) hydraulic pressure, and (e) external force. The flexible stem may be configured to flex in cooperation with a force applied to the anchor.

The barbs may be formed to resist proximal movement of the anchor after the anchor has been driven and pushed into the tissue. The barb extends to the free end and may include a plurality of proximally extending cutting protrusions at the free end. The fold may provide a plurality of proximally extending cutting protrusions at the free end of the barb.

The anchors may be arranged in a configuration having a plurality of anchors along a ring-shaped circumference. The anchors may be arranged in a square shape having a plurality of anchors. The anchor may be formed of a bioabsorbable material.

The flexible stem may further include a proximal eyelet configured to receive the closure element. The closure element may be a suture.

According to a preferred embodiment of the present invention,
Surgical equipment
An anchor, the anchor comprising a distal end tapered toward a distal tip formed to pierce tissue and extending from the distal end proximally and radially outwardly to a free end. At least one hook extending from the distal end of the shoulder of the anchor and a flexible stem extending proximally from the distal end, the shoulder having a hook and a hook. Of an anchor, located at or distal to the distal portion of the part, and a driving force on the anchor and the shoulder of the anchor to drive the anchor into tissue A driver formed in such a manner that the hook includes a radially outer surface and a radially inner surface, the radially outer surface includes a longitudinally extending fold, and the fold is proximal. Providing a plurality of laterally extending projections at the free end.

The anchors may be arranged in a configuration having a plurality of anchors, and further the driver is configured to drive the anchors simultaneously. The driver may be configured to drive the anchor a predetermined distance. The driver may comprise a spring loaded element configured to impact the anchor and impart distally directed momentum to the anchor.

The barb may extend beyond the shoulder proximally. The driver may include a pin in contact with the shoulder of the anchor, the pin configured to drive the anchor distally and force it into the tissue.

In accordance with a preferred embodiment of the present invention, a surgical device includes a distal end tapered toward a distal tip formed to pierce tissue, and proximally and radially outwardly from the distal end. A surgical anchor including at least one barb extending toward a free end, at least one window formed to allow the barb to expand to a relaxed position, and compressing the barb A delivery mechanism having a distal end including at least one constriction element configured to compress to a position, the barb including a radially outer surface and a radially inner surface, The barb is in a relaxed position before the delivery mechanism ejects the anchor, with the radially outer surface including a longitudinally extending fold, the fold providing a plurality of proximally extending protrusions at the free end. And the hook faces the constriction element such that the barb narrows from the relaxed position to the compressed position while the delivery mechanism ejects the anchor, and the barb is removed from the delivery mechanism. It is shaped to return to its relaxed position once ejected.

In accordance with a preferred embodiment of the present invention, a surgical device includes a distal end tapered toward a distal tip formed to pierce tissue, and proximally and radially outwardly from the distal end. A surgical anchor including at least one barb extending toward a free end, a flexible stem extending proximally from a distal end, and a proximal eyelet, and received by the proximal eyelet. And a tensioner, the hollow axial core formed to receive the closure element and to allow the closure element to slide through the tensioner. And a tensioner including. The closure element may be a suture.

Further features and aspects of the present invention are detailed below with reference to the accompanying drawings.

FIG. 3 shows a detailed view of a surgical device and a distal tip of the surgical device according to a preferred embodiment of the present invention. FIG. 3 shows a detailed view of a surgical device and a distal tip of the surgical device according to a preferred embodiment of the present invention. FIG. 2 is a front view of the surgical closure device of FIG. 1 with a partial front view inserted. 2 shows an anchor of the self-actuating closing mechanism of the device of FIG. 2 shows a partial assembly of the surgical closure device of FIG. FIG. 5 is a partial view showing the partial assembly of FIG. 4. FIG. 2 is a partial cross-sectional view of the device of FIG. 1 shown in cross-section in the plane containing the longitudinal axis of the device and dividing two opposing anchors. FIG. 5B is a partial cross-sectional view of the subassembly of FIG. 5A with the safety mechanism engaged. FIG. 5B is a partial cross-sectional view of the subassembly of FIG. 5A with the safety mechanism engaged and disengaged. FIG. 5B is a partial cross-sectional view of the subassembly of FIG. 5A showing the condition when the trigger is depressed. 2 is a partial view of the working tube and self-actuating closure mechanism of the surgical closure device of FIG. 1. FIG. It is sectional drawing based on the plane A of FIG. FIG. 8 is a cross-sectional view based on plane A of FIG. 7 when the cannula is placed in the outer working tube. 8B illustrates the retracting of the cannula of FIG. 8B relative to the outer working tube and the release of the closure element in a continuous and schematic manner. 8B illustrates the retracting of the cannula of FIG. 8B relative to the outer working tube and the release of the closure element in a continuous and schematic manner. 8B illustrates the retracting of the cannula of FIG. 8B relative to the outer working tube and the release of the closure element in a continuous and schematic manner. 2 is a partial view of the outer working tube of the device of FIG. 1 with an automatically actuated closure mechanism inserted into tissue. FIG. 2 is a partial view of the outer working tube and cannula with the self-actuating closure mechanism of the device of FIG. 1 inserted into tissue. FIG. Figure 3 shows the self-actuating closure mechanism of the device of Figure 1 inserted into tissue after removal of the cannula and working tube. 10B schematically illustrates the force exerted by the anchor of FIG. 10A. 10B schematically illustrates the force exerted by the anchor of FIG. 10A. FIG. 10B shows the anchor of FIG. 10A when retracted to a closed or approximated position of the anchor to close a hole in tissue. FIG. 10B shows the anchor of FIG. 10A when retracted to a closed or approximated position of the anchor to close a hole in tissue. 6 shows a closure element having a V-shaped configuration according to a preferred embodiment of the present invention. 6 shows another V-shaped closure element according to a preferred embodiment of the present invention. 3 illustrates an anchor according to a preferred embodiment of the present invention. Figure 14 shows the plurality of anchors of Figure 13 and the closure element of Figure 12 when the holes in the tissue are closed. 3 illustrates a surgical closure device according to a preferred embodiment of the present invention. 16 is a front perspective view of the distal end of the surgical closure device of FIG. 15 with anchors and closure elements. 16 is a partial view showing a partial assembly of the apparatus of FIG. 15. FIG. FIG. 16 is a side view showing a trigger of the device of FIG. 15. 16 is a top view showing a trigger of the device of FIG. 15. FIG. FIG. 16 is a bottom view showing the trigger of the device of FIG. 15. FIG. 16 is a partial view of the trigger subassembly of the apparatus of FIG. 15 with the trigger in an initial state. 19 is a partial view of the trigger subassembly of FIG. 18 with the trigger depressed. FIG. FIG. 16 is a front cross-sectional view of a partial assembly of the apparatus of FIG. 15 with the key plate in the engaged state and the first position. 18C is a front cross-sectional view of the subassembly of FIG. 18C with the key plate in the disengaged state and the first position. FIG. 18C is a front cross-sectional view of the subassembly of FIG. 18C with the key plate in the disengaged state and the second position. FIG. FIG. 16 is a schematic view showing engagement between a trigger bar and a hammer sleeve of the device of FIG. 15. FIG. 16 is a schematic view showing the trigger bar of the device of FIG. 15 disengaged from the hammer sleeve. FIG. 16 is a schematic front view of the latch member and safety switch of the device of FIG. 15 with the safety switch engaged. FIG. 16 is a schematic front view showing the latch member and safety switch of the device of FIG. 15 with the safety switch in the disengaged state. Figure 6 shows an anchor pushed into tissue without a closure element. 20B illustrates the tissue of FIG. 20A punctured at a location within the perimeter defined by the anchor. 20B shows anchors placed around the hole formed in FIG. 20B. 20B and 20C closed by anchors and closure elements. Figure 3 shows an anchor surrounding the punctured tissue. FIG. 3 is a perspective view showing a tissue compression band assembly according to a preferred embodiment of the present invention. FIG. 6 is a cross-sectional view showing a tissue compression band assembly according to a preferred embodiment of the present invention. FIG. 4 is a side view showing a tissue compression band assembly according to a preferred embodiment of the present invention. FIG. 4 is a side view showing a tissue compression band assembly according to a preferred embodiment of the present invention. FIG. 3 is a perspective view showing a tissue compression band assembly according to a preferred embodiment of the present invention. FIG. 5 is a front view of an end and tissue compression band assembly according to a preferred embodiment of the present invention. FIG. 6 is a perspective view of an end and tissue compression band assembly according to a preferred embodiment of the present invention. FIG. 3 is a perspective view showing a pusher plate according to a preferred embodiment of the present invention. FIG. 6 is a cross-sectional view showing a tissue compression band assembly and pusher pin according to a preferred embodiment of the present invention. 6 illustrates a tissue compression band assembly and tissue opening according to a preferred embodiment of the present invention. 6 illustrates a tissue compression band assembly and tissue opening according to a preferred embodiment of the present invention. 6 illustrates a tissue compression band assembly and tissue opening according to a preferred embodiment of the present invention. 6 shows tissue closed by a tissue compression band assembly according to a preferred embodiment of the present invention. FIG. 4 is a schematic front view showing an array of tissue compression band assemblies according to a preferred embodiment of the present invention. FIG. 4 is a schematic front view showing an array of tissue compression band assemblies according to a preferred embodiment of the present invention. FIG. 4 is a schematic front view showing an array of tissue compression band assemblies according to a preferred embodiment of the present invention. FIG. 4 is a schematic front view showing an array of tissue compression band assemblies according to a preferred embodiment of the present invention. FIG. 4 is a schematic front view showing an array of tissue compression band assemblies according to a preferred embodiment of the present invention. FIG. 4 is a schematic front view showing an array of tissue compression band assemblies according to a preferred embodiment of the present invention. FIG. 6 is a front view of an end according to a preferred embodiment of the present invention. FIG. 6 is a front view of an end and tissue compression band assembly according to a preferred embodiment of the present invention. FIG. 6 is a perspective schematic view of an end and tissue compression band assembly according to a preferred embodiment of the present invention. FIG. 6 is a perspective view of a large hole closure according to a preferred embodiment of the present invention. FIG. 6 is a perspective view of a large hole closure according to a preferred embodiment of the present invention. FIG. 6 is a perspective view of a large hole closure according to a preferred embodiment of the present invention. FIG. 6 is a perspective view of a large hole closure according to a preferred embodiment of the present invention. FIG. 6 is a perspective view of a large hole closure according to a preferred embodiment of the present invention. FIG. 6 is a perspective view of a large hole closure according to a preferred embodiment of the present invention. FIG. 6 is a perspective view of a large hole closure according to a preferred embodiment of the present invention. FIG. 6 is a perspective view of a large hole closure according to a preferred embodiment of the present invention. FIG. 6 is a perspective view of a large hole closure according to a preferred embodiment of the present invention. FIG. 31 is a perspective view showing a sliding brace of the device of FIGS. 13A and 31B. FIG. 6 is a perspective view of a large hole closure according to a preferred embodiment of the present invention. FIG. 6 is a perspective view of a large hole closure according to a preferred embodiment of the present invention. FIG. 3 is a perspective view showing a percutaneous tissue closure device according to a preferred embodiment of the present invention. FIG. 3 is a perspective view showing a percutaneous tissue closure device according to a preferred embodiment of the present invention. FIG. 3 is a perspective view showing a percutaneous tissue closure device according to a preferred embodiment of the present invention. FIG. 3 is a perspective view showing a percutaneous tissue closure device according to a preferred embodiment of the present invention. 3 illustrates a percutaneous tissue closure device and tissue opening according to a preferred embodiment of the present invention. 3 illustrates a percutaneous tissue closure device and tissue opening according to a preferred embodiment of the present invention. 3 illustrates a percutaneous tissue closure device and tissue opening according to a preferred embodiment of the present invention. 3 illustrates a percutaneous tissue closure device and tissue opening according to a preferred embodiment of the present invention. 3 illustrates a percutaneous tissue closure device and tissue opening according to a preferred embodiment of the present invention. 3 illustrates a percutaneous tissue closure device and tissue opening according to a preferred embodiment of the present invention. 3 illustrates a percutaneous tissue closure device and tissue opening according to a preferred embodiment of the present invention. 3 illustrates a percutaneous tissue closure device and tissue opening according to a preferred embodiment of the present invention. 3 illustrates a percutaneous tissue closure device according to a preferred embodiment of the present invention. 3 illustrates a percutaneous tissue closure device according to a preferred embodiment of the present invention. 3 illustrates a percutaneous tissue closure device according to a preferred embodiment of the present invention. 3 illustrates a percutaneous tissue closure device according to a preferred embodiment of the present invention. 3 illustrates a percutaneous tissue closure device according to a preferred embodiment of the present invention. 3 illustrates a percutaneous tissue closure device according to a preferred embodiment of the present invention. 6 shows a cam of a percutaneous tissue closure device according to a preferred embodiment of the present invention. 6 shows a sleeve of a percutaneous tissue closure device according to a preferred embodiment of the present invention. 3 illustrates a working tube of a percutaneous tissue closure device according to a preferred embodiment of the present invention. 3 illustrates a working tube of a percutaneous tissue closure device according to a preferred embodiment of the present invention. 3 illustrates an anchor according to a preferred embodiment of the present invention. 6 shows a deployed arrangement of anchors and closure elements according to a preferred embodiment of the present invention. 3 illustrates an anchor according to a preferred embodiment of the present invention. 1 illustrates a tensioning device according to a preferred embodiment of the present invention. 1 illustrates a tensioning device according to a preferred embodiment of the present invention. FIG. 6 shows the deployment of the distal end and anchor of a surgical closure device according to a preferred embodiment of the present invention. FIG. 6 shows the deployment of the distal end and anchor of a surgical closure device according to a preferred embodiment of the present invention. FIG. 6 shows the deployment of the distal end and anchor of a surgical closure device according to a preferred embodiment of the present invention. FIG. 6 shows the deployment of the distal end and anchor of a surgical closure device according to a preferred embodiment of the present invention. FIG. 6 shows the deployment of the distal end and anchor of a surgical closure device according to a preferred embodiment of the present invention. FIG. 6 shows the deployment of the distal end and anchor of a surgical closure device according to a preferred embodiment of the present invention. FIG. 6 shows the deployment of the distal end and anchor of a surgical closure device according to a preferred embodiment of the present invention. FIG. 6 shows the deployment of the distal end and anchor of a surgical closure device according to a preferred embodiment of the present invention.

As shown in more detail below, preferred embodiments of the present invention allow reliable and effective closure of tissue openings (eg, pericardial or myocardial windows), which may, for example, necessitate suturing. By eliminating them, you limit the potential for human error. In some examples, the surgical device secures a plurality of anchors in tissue that are coupled together by one or more elastic closure elements. The anchors are driven into the tissue in a spaced configuration with elastic closure elements placed under tension between the anchors. The anchors are held in a spaced apart arrangement during a surgical procedure through a tissue opening formed between anchoring positions of the anchors. To close the opening, the device simply releases the anchor from the spaced apart arrangement so that the elastic closure element under tension pulls the anchor, as well as the tissue to which it is anchored, toward the tissue opening. is there. This keeps the tissue opening closed. Tension remaining in the elastic closure element may enter the anchor by at least one of (a) tissue, (b) fluid flow, (c) air pressure, (d) hydraulic pressure, and (e) external force. Offset the opposing forces.

For example, referring to FIGS. 1-10E, the surgical procedure involves positioning the surgical closure device 5 at a surgical entry location, such as a location on the heart wall when access to the interior of the heart is desired. The surgical closure device 5 is then actuated, for example via a trigger, to drive the plurality of anchors 200 into the tissue at predetermined locations spaced around the surgical entry location. The anchor 200 is preloaded towards the entry position by means of a pretensioned closure element 300 in the form of an elastic band. Anchor 200 is maintained in these outer positions by cannula 400 and/or outer working tube 100. After the anchor 200 is activated, the surgical device, except for the cannula 400, outer working tube 100, anchor 200, and closure element 300, is removed.

Cannula 400 then provides a working channel. Surgical procedures can be performed through this working channel. For example, tissue 900 can be punctured by extending the trocar through the channel of cannula 400. The catheter, guidewire, and/or other device can then be inserted through the working channel based on any suitable interventional or surgical procedure. Any catheter or other device extending through the working channel is withdrawn to complete the procedure, and the cannula 400 and working tube 100 are withdrawn proximally from the surgical entry site. By retracting the cannula 400 and working tube 100, the pre-tensioned closure element 300 pulls the anchor 200 toward the surgical entry site. Since the anchor 200 is anchored within the tissue surrounding the surgical entry site, this results in the tissue surrounding the surgical entry site being brought together, thereby closing the surgical entry hole. In contrast to conventional procedures, suturing is not required.

Although cannula 400 is provided separately from outer working tube 100, it should be understood that the preferred embodiment may include only one tube. For example, the cannula 400 is not provided in the device 5, and the working tube 100 functions as the cannula.

1 and 2 show an example of a surgical closure device 5. Surgical closure device 5 includes a handle 10 configured to be held by an operator, eg, a surgeon, for operating surgical closure device 5 during a surgical procedure. A shaft 20 extends distally from the handle 10 and includes a distal end 25. An outer working tube 100 is arranged in the hole of the shaft 20, and the outer working tube 100 extends coaxially along the longitudinal axis x of the shaft 20. The outer working tube 100 is exposed distally through an opening in the shaft 20. The outer working tube 100 has an outer diameter smaller than the inner diameter of the shaft 20, and thus the outer working tube 100 is slidable along the longitudinal axis x. It will be appreciated that although outer working tube 100 and shaft 20 are each formed as a right circular cylinder with a coaxial through hole, outer working tube 100 and/or shaft 20 may have any suitable geometry, such as an ellipse. It may have a cross section such as a shape, a polygon, and/or a cross section that varies along the longitudinal axis x. Further, the geometry of the holes may be significantly different than the outer geometry of outer working tube 100 and/or shaft 20.

Referring to the inset partial view of FIG. 1, the distal end 25 of the shaft 20 includes six notches, or slots 26. These notches or slots 26 extend a predetermined distance along the longitudinal axis x from the distal tip of the shaft 20 proximally. The slots 26 may be formed in any suitable manner, for example, by forming three notches in the distal end 25, each notch forming two slots 26 on opposite sides of the axis x. The dimensions of the slot 26 are selected to allow six respective anchors 200 to be placed within the slot 26. In this regard, the wall thickness of the shaft (ie, the hole-to-outer surface separation), and the width of each slot 26 may be selected to be slightly larger than the respective lateral dimension of the anchor 200. If the anchor 200 has radial protrusions, the width of the slot 26 may be less than the diameter of the anchor through the protrusion. Therefore, the geometry of the slot 26 may require that the anchor 200 be oriented such that the radial protrusions are at least approximately aligned with the longitudinal axis x of the shaft 20. This is because otherwise anchor 200 will not fit into slot 26.

FIG. 3 is a front view of the surgical closure device 5. The slots 26 with their respective anchors 200 are non-uniformly spaced around the circumference of the shaft 20. Specifically, the two slot groups 26 are provided with one group being located on the opposite side of the axis line x from the other group. Each of the two groups contains three slots 26 equally spaced. The circumferential spacing between the groups is greater than the circumferential spacing between the individual slots 26 in each group.

3, the slot 26 includes sidewalls with opposed longitudinally extending cylindrical grooves 27 for receiving the body 201 of the anchor 200. Furthermore, the closure element 300 attached to the anchor 200 can pass along the cylindrical groove 27. The slot 26 is also radially elongated to accommodate the wings 207 and 208. These wings are detailed below in connection with FIG. Further, the presence of a gap between the outer working tube 100 and the end 25 of the shaft 20 allows the closure element 300 to be disposed therebetween, as shown in FIG. ..

FIG. 4 shows an anchor or implant 200. The anchor or implant 200 is configured to be driven and forced into tissue. The anchor 200 includes a pleated body 201. The body 201 includes a groove 203 extending along the length of the body 201 in the axial direction. In this way, the plurality of grooves 203 and the plurality of ridges 205 extend alternately in the circumferential direction of the body 201. Further, the anchor body 201 includes a pair of wings or splits 207 and 208. The splits 207 and 208 are formed by respective crevices or cuts 209 made in the body 201. In this regard, the split 209 may be formed by making a radial cut into the body 201 and extending it axially. Thus, the two splits 207 and 208 attach to the rest of the body 201 in the distal position and extend proximally to the free end. The free end includes a plurality of sharp protrusions along the curved surface. These tips are formed based on folds. Specifically, as shown in the side view of the insertion portion in FIG. 4, the ridges 205 form sharp protrusions. These protrusions are advantageous for grasping tissue and blocking distal sliding of anchor 200. Of course, although each split 207 and 208 includes three such protrusions as shown, anchor 200 may be configured such that one or more of the splits is a single sharp protrusion. May be configured to have any other number of protrusions including For example, if more sharp protrusions are desired, a tighter fold can be applied to the body 201 (ie, more staggered grooves 203 and ridges 205 can be provided), and Alternatively, the angle of the cut or slice can be adjusted. Furthermore, by varying the depth of the groove 203 relative to the ridge 205, the length by which the protrusion extends proximally can be adjusted.

The splits 207 and 208 resist movement from the insertion site proximally by engaging the tissue, rather than significantly impeding distal insertion into the tissue. It has been found that the combination of the pointed and/or sharpened proximal ends of the splits 207 and 208 with alternating ridges at the proximal ends of the splits improves performance.

Furthermore, the splits or wings 207 and 208 are axially offset from each other. For example, the dividing part 207 is arranged at a position along the axis xx in the axial direction, and the dividing part 208 is arranged at a position b along the axis xx in the axial direction. This allows for greater structural strength in other parts of the body 201 as compared to the non-staggered configuration. Specifically, the discontinuities progress radially inward continuously as they progress distally, so in the case of the non-displaced configuration, that portion is of cross-section at the distal end of the discontinuity. The amount of material is significantly reduced. This leads to mechanically weak points or regions along the axis of the body, which can lead to mechanical defects, especially for small size anchors. Although anchor 200 utilizes a pair of wings 207 and 208 to secure anchor 200 against proximal withdrawal from tissue, it goes without saying that any number of wings may be used. Alternatively, or in addition to or in addition to wings 207 and 208, any other suitable anchoring structure, such as anchoring filaments, may be provided.

The distal tip of anchor 200 is pramid-shaped and has a sharp tip and a plurality of faces separated by converging edges at the sharp tip. Although four flat surfaces are provided, it goes without saying that any suitable number of surfaces may be provided and one or more or all or all of the surfaces may not be flat.

The anchor 200 also includes a hooked end 210. The hooked end 210 is configured to receive one or more closure elements 300. An alignment protrusion 220 is provided on the side of the anchor 200 opposite to the hook-shaped portion 210. The alignment protrusion 220 is formed to rotationally align the anchor 200 about its longitudinal axis xx. The anchor 200 of the illustrated example is aligned with the alignment protrusion 220 and the splits 207 and 208, the alignment protrusion 220 and the splits 207 and 208 being a plane that includes the longitudinal axis x of the shaft 20 and the longitudinal axis xx of the anchor 200. Needless to say, the alignment projection 220 and the splits 207 and 208, although intersected by and aligned along this plane, include the longitudinal axis xx of the anchor 200 and the longitudinal axis x of the shaft 20 and the device 20. May be intersected transversely to the plane containing the longitudinal axis xx of, and perpendicular to, and aligned with. Further, alignment protrusions may be provided at any suitable location around the anchor 200 relative to the splits 207 and 208, and any suitable number of alignment protrusions 220 may be provided for a particular anchor 200. Good.

Anchor 200 may include one or more shoulders. The shoulder may be formed by the junction of the wings 201 and 208 and the body 201, or the wings 207 and 208 may extend proximally and radially outward from the distal end, or may be further than the distal end. It is defined by the area of anchor 200 on the proximal side. As shown in FIG. 4, the wings 207, 208 have a relaxed, uncompressed position, but can be compressed to a second compressed position closer to the body. In addition, the body 201 may be flexible so that forces received in the proximal end affect the wings 207 and 208 and the position of the body or stem 201 with respect to the distal end. be able to.

Although the anchor 200 is illustrated as having a closure element 300, it should be understood that the anchor 200 may be used with any other closure element including, for example, the closure elements 1300, 2300 detailed below. ..

The anchor 200 is formed by first forming a body 201 with pleats, for example by injection molding or extrusion, and subsequently forming splits 207 and 208, for example by making radial cuts in the sides of the body 201. May be manufactured by. As shown, the incision curves with the angle (at the proximal entry point) to the longitudinal axis xx of the body 201 tapering from the proximal initial cutting point toward the distal end of the anchor 200. And finally becomes linear. It will be appreciated that although the splits or cuts in the illustrated example are formed to have a curved or varying angle with respect to the longitudinal axis xx of the body 201, it goes without saying that any suitable cut including a linear cut. May be formed.

The anchor 200 includes two wings or splits evenly spaced around the radial perimeter of the body 201, but needless to say, any number of splits, including a single split. The portions may be provided around the radial perimeter of anchor 200 at any suitable spacing.

Current manufacturing methods allow the application of near nanotechnology. This allows anchor 200 to be manufactured in sizes and complexity not previously possible. Anchor 200 may be injection molded from an absorbable or non-absorbable polymer and then processed (eg, by cutting) to add the features of wings 207 and 208. Although anchor 200 is formed of a polymer, any suitable material may be used, such as a metal or composite material. Anchor 200 may be, for example, 1 millimeter in diameter, or approximately 1 millimeter, and may be, for example, 5 millimeters to 10 millimeters in length. According to some preferred embodiments, the diameter is less than 1 millimeter. According to some preferred embodiments, the diameter is between 0.8 millimeters and less than 1.2 millimeters. However, it goes without saying that other dimensions may be provided.

FIG. 5 shows a partial assembly of the surgical closure device 5. The subassembly includes a trigger 30, a safety slide 35, a safety slide biasing spring 40, a hammer sleeve 500, a drive spring 550, an anvil pin 600, an outer working sleeve 100, and an anchor 200. .. In the state shown in FIG. 5, the surgical closure device 5 is loaded and ready to be actuated to drive the anchor 200. In this regard, the proximal end of hammer sleeve 500 contacts the distal end of drive spring 550. The drive spring 550 is in compression as shown in FIG. In order to maintain the hammer sleeve 500 in its proximal position while the compressed drive spring 550 exerts a force directed distally, the hammer sleeve 500 is schematically illustrated in FIG. 6A. Reference numeral 500 latches with the trigger plate 32 of the trigger 30. 6A-6C, hammer sleeve 500 and trigger plate 32 are shown in cross section for ease of illustration. To latch the hammer sleeve 500, the hammer sleeve 500 is pushed proximally while the trigger 30 is depressed until the lip or step rides proximally over the proximal side of the trigger plate 32. (Eg, as shown in FIG. 4C). The trigger 32 is then moved (eg, via a spring bias and/or manually) to an undepressed position, as shown in FIG. 6A. The trigger moves laterally between a depressed position and a non-depressed position by sliding within a lateral channel within the housing of the handle 10. However, any suitable guiding mechanism may be provided.

The safety slide includes safety ribs or bars 38 to maintain the trigger 32 in the undepressed position to prevent or reduce accidental actuation of the anchor 200. The safety rib or bar 38 is positioned adjacent the trigger plate 32 as shown in FIG. 6A to form a positive or hard stop, which causes the trigger 30 to be undepressed in FIG. 6A. Preventing movement from the position to the depressed position of Figure 6C. For example, as shown in FIG. 6A, safety slide 35 includes a pair of lateral protrusions 36. The lateral protrusions are formed to slide longitudinally within corresponding channels provided in the housing of the handle 10. However, any suitable guiding mechanism may be provided. The safety slide 35 also includes a knob portion 37 to facilitate the sliding of the safety slide 35, for example with one finger of the operator.

When the operator wishes to drive the anchor 200, he must first move the safety slide 35 to the drive position. In the drive position, the safety bar 38 does not impede the movement of the trigger plate 32. Referring to FIG. 5, the safety slide is urged or biased by the compression spring 40 toward the proximal safety position. Therefore, the operator must continuously apply force to the knob 37 until the bottom of the trigger plate 32 moves to a position that prevents or blocks the safety bar 38 from returning to the safe position. This can provide even higher safety. This is because the operator usually has to coordinate the holding of the safety slide 35 in the drive position while depressing the trigger 30. However, it goes without saying that the safety slide 35 may also be configured to remain in the drive position without continuous application of force. Furthermore, it goes without saying that the device 5 may be provided without any safety mechanism.

FIG. 6B shows the safety slide 35 in the drive position. Although the safety slide has been moved distally, ie in the direction of the arrow shown in FIG. 6B, it should be understood that the safety switch may be moved in any suitable direction to move between the safe and fired positions. May be configured to move to. After the safety slide 35 has been moved to the drive position shown in FIG. 6B, the lower portion of the trigger plate 32 rides over the step 505 of the hammer sleeve 500, which causes the distal end to be actuated by the compressed drive spring 550. The operator depresses the trigger 30 with, for example, one finger of the operator until the hammer sleeve 500 is released for movement to the position side.

For example, referring to the partial cross-sectional view of FIG. 6B, the hammer sleeve 500 is spaced from the anvil pin 600 before the trigger is depressed. The anvil pin 600 is slidable within the respective bores of the shaft 20 corresponding to the respective anchors 200 along the longitudinal axis x of the shaft 20. As the hammer sleeve 500 advances, it gains speed and momentum. Upon contacting the proximal end of anvil pin 600, anvil pin 600 imparts momentum to anchor 200. This is because the distal end of the anvil pin 600 is aligned with the proximal end of the anchor 200. Thus, the anchor 200 is driven at a considerable speed. This facilitates driving anchor 200 into soft tissue.

The anchors are preferably driven at speeds greater than 50 meters per second, more preferably 50-350 meters per second, and most preferably 350 meters per second. However, it should be appreciated that anchor 200 may be driven at any suitable speed sufficient to allow the anchor to pierce tissue.

Further, the anchor 200 may be driven and forced into a single or multiple layers of tissue, and the speed may be dependent upon the structural characteristics, dimensions, and relative location of one or more tissues into which the anchor is pushed. May be selected based on

Rapid penetration into each tissue layer may be necessary to provide penetration into the soft tissue, which is not retained or anchored at the distal side, for accurate penetration. When anchor 200 is applied at a slow rate, the tissue is urged distally by anchor 200 without sufficient penetration. Thus, some example delivery mechanisms eject each implant relatively fast, as described above. Although Example Device 5 utilizes a spring loaded mechanical drive mechanism, it goes without saying that other drivers may be provided. In some examples, saline is used to pressurize a channel inside a catheter, needle, or other tube at a rate such that the plunger ejects the anchor at the correct rate. In a further preferred embodiment, a long push rod extending the length of the catheter or other tube is used to push the anchor. The ejection modality may be computer controlled and/or operator controlled. For example, similar to the spring loaded mechanical system of the illustrated example, the ejection force can be predetermined and repeated by the operator actuating the trigger 30.

Further, the driver may be configured to drive the anchor 200 to a predetermined depth. In the example shown, the depth is controlled by contact between the anchor 200 and the closure element 300 (detailed below) coupled to the flange or flared portion 405, but any other depth control mechanism may be used. It may be provided additionally or alternatively. For example, depth accuracy can be achieved by precise hydraulic drive, engagement with other stoppers, or sutures that are tensioned to limit depth. Further, depth may be monitored using fluoroscopy, echocardiography, intravascular ultrasound, or any other suitable imaging mechanism. The drive mechanism may include pressurized saline or other hydraulic fluid pressurized through the thoracoscopic catheter shaft. In this way, extremely precise control can be achieved.

FIG. 6 is an enlarged partial view of the subassembly of FIG. As shown, the plurality of closure elements 300 are coupled to the hook portion 210 of the anchor 200. There are four closure elements 300. Each of these is precisely coupled to the hook portions 210 of the two anchors 200. Thus, for example, as shown in FIG. 10, two anchors 200 are attached to exactly two different closure elements 300, and four anchors are attached to exactly one closure element 300. However, it goes without saying that other sequences may be provided.

FIG. 7 is a partial view of working tube 100, anchor 200, and closure element 300. As shown in FIG. 7, the anchor 200 has been driven and pushed into, for example, tissue. The anchor 200 and the closure element 300 form the self-actuating closure mechanism of the surgical closure device 5. During driving of the anchor 200, the closure element 300 is also driven a similar distance based on the engagement of the closure element 300 with the anchor 200.

Referring to the cross-sectional view of FIG. 8A, the closure element 300 is layered and is retained along the perimeter of the outer working tube 100, thereby preventing the closure element 300 from pulling the anchor 200 toward each other.

8B is the same as FIG. 8A except that the cannula 400 is located inside the outer working tube 100. The elements shown in FIG. 8B may be separated from the rest of surgical device 5 to allow a surgical procedure to be performed. For example, a trocar may be longitudinally inserted through the interior of cannula 400 to puncture tissue at a location surrounded by anchor 200 anchored in the tissue. Tissue puncture can allow access to the opposite side of the tissue (eg, internal organs such as the heart) by thoracoscopic instruments, including guidewires and catheters, or other surgical and interventional instruments.

Cannula 400 includes six radially extending flared portions or flats 405. Cannula 400 extends coaxially within outer working tube 100. Because cannula 400 extends distally beyond the distal end of outer working tube 100, flat 404 folds over the distal end of outer working tube 100. The radial extension of the flat 405 over the circumferential perimeter of the outer working tube 100 causes the flat 405 to form a positive or hard stop. These stoppers prevent or resist inadvertent sliding of the closure element 300 from the end of the outer working tube 100, for example, while a thoracoscopic procedure is being performed by access through the cannula 400.

When the procedure no longer requires access through the cannula 400, any surgical instrument can be retracted through the cannula 400 from the viscera being manipulated. At this stage, the tissue holes formed by the trocar should be closed. To do so, cannula 400 is moved relative to outer working tube 100, as shown sequentially in FIGS. 8C and 8D. In doing so, the flat 405 formed as a leaf spring pivots into a longitudinal orientation and is retracted. Thus, the flat 405 no longer forms a stop against the sliding of the closure element 300 distally along the outer working tube 100. This orientation is shown in Figure 8D. Flat 405 may be formed of any suitable material, for example, a shape memory material such as Nitinol, spring steel, or the like.

The flat 405 may be bistable in two static orientations, one corresponding to a flared radial orientation and the other to a longitudinal orientation.

After the flat is retracted, the cannula 400 and outer working tube 100 are retracted proximally from the surgical entry site. The closure element 300 is engaged with the hook-like portion 210 of the anchor 200 anchored in tissue against proximal withdrawal so that the closure element remains adjacent to the surgical closure site. Thus, withdrawing cannula 400 and outer working tube 100 proximally causes outer working tube 100 to slide distally with respect to closure element 300. By retracting the cannula 400 and the outer working tube 100 further distally, the closure element 300 slides off the distal end of the outer working tube 100, thereby causing the closure element 300, and the anchor 200 to exit the cannula 400 and the working tube 100. Engage and disengage overall. The closure element 300 is pre-tensioned so that the anchor 200 is pulled towards the hole formed at the surgical entry site. Because anchor 200 is anchored in the tissue surrounding the hole, pulling the anchors closer together pulls the surrounding tissue toward the hole. Therefore, the aperture is squeezed and closed, and the closure element 300 maintains the closing force to keep the aperture closed.

FIG. 9A is a partial view of outer working tube 100 with anchor 200 inserted into tissue 900. FIG. 9B is the same as FIG. 9B, but schematically shows the flat 405. The flats 405 extend between the outer working tube 100 and the closure element 300 to prevent the closure element 300 from causing premature or inadvertent closure of the tissue entry opening. FIG. 9B may be a working arrangement with parts of surgical device 5 other than cannula 400, outer working tube 100, anchors 200, and closure element 300 removed. As such, various other surgical instruments, such as catheters, guidewires, and other instruments, can be manipulated through the interior of cannula 400 and outer working tube 100.

FIG. 10 shows the self-actuating closure mechanism, in this case the anchor 200 and closure element 300 being inserted into tissue after removal of the cannula 400 and working tube 100. For purposes of illustration, anchor 200 is shown in an initial drive position within tissue 900. In other words, for ease of illustration, this mechanism is shown as if the anchors 200 were prevented from being pulled together by the closure element 300. Anchor 200 is disposed around surgical access opening 905 formed, for example, by a trocar.

The anchors 200 are arranged in two opposite anchor groups. Anchors 200 are individually labeled 200a, 200b, 200c, 200d, 200e, and 200f to facilitate description of the mechanism shown in FIG. 10A. The first group includes anchors 200a, 200b, and 200c, and the second group includes anchors 200d, 200e, and 200f. Each anchor of each group is directly connected by the closure element 300 to at least one anchor of the other group. Furthermore, the two anchors in either group are not directly connected to each other by the closure element. That is, each closure element 300 is connected at one end to the anchors of the first group 200a, 200b, and 200c and at the other end to the anchors of the first group 200d, 200e, and 200f. Therefore, the force exerted by the element 300 is primarily directed from one group towards the other.

As can be further seen in FIG. 10A, the anchor/closure element mechanism is formed as two oppositely overlapping V-shaped groups. The first V-shaped group is formed from anchors 200a, 200e, and 200c and closure elements 301, 304. The second V-shaped group is formed from anchors 200d, 200b and 200f and closure elements 302, 303.

Since each closure element is wrapped around two anchors to form a single complete loop, the force exerted by each closure element on each anchor is equal to the two anchors to which the closure elements are joined. Equal to the sum of the tensions in the two band portions extending between Furthermore, the force is applied along a line extending between the two anchors to which the closure element is connected. In this regard, the forces applied at the locations of anchors 200a, 200b, 200c, 200d, 200e, and 200f are shown in FIG. Is shown in. Specifically, F301a represents the force applied by the closure element 301 at the anchorage point of the anchor 200a, F301e represents the force applied by the closure element 301 at the anchorage point of the anchor 200e, and F302b is the anchorage of the anchor 200b. Represents the force exerted by the closure element 302 at a point, F302d represents the force exerted by the closure element 302 at the anchoring point of the anchor 200d, F303b represents the force exerted by the closure element 303 at the anchoring point of the anchor 200b, F303f represents the force exerted by the closure element 303 at the anchor point of the anchor 200f, F304c represents the force exerted by the closure element 304 at the anchor point of the anchor 200c, and F304e is the closure element at the anchor point of the anchor 200e. Represents the force applied by 304. Furthermore, these forces form three pairs of complementary forces that are equal and opposite to each other. Specifically, the first pair F301a, F301e, the second pair F302b, F302d, the third pair F303b, F303f, the fourth pair F304c, F304e. Each pair corresponds to a respective single closure element 301, 302, 303, 304, and a respective closure element 301, 302 between the two anchors 200 to which the respective closure element 301, 302, 303, 304 is coupled. , 303, 304 are oriented in opposite directions.

Since the anchors 200a, 200c, 200d, 200f are respectively coupled to a single closure element 301, 304, 302, 303, only a single vector F301a, F304c, F302d, F303f is shown in FIG. 10B. .. Since anchors 200b and 200e are each coupled to two closure elements, two force vectors cooperate with anchors 200b and 200e, respectively, in FIG. 10B. That is, the anchor 200b coupled to the closure elements 302 and 303 has two force vectors F302b and F303b acting through the anchorage points of the anchor 200b, and the anchor 200e coupled to the closure elements 301 and 304 is It has two force vectors F301e and F304e acting through the anchorage point of the anchor 200b.

Since the forces represented by the vectors F302b and F303b both act through the same location, that is, the anchorage point of the anchor 200b, the resultant force through the anchorage point of the anchor 200b is defined as the sum of the two vectors F302b and F303b. You can Similarly, since the forces represented by vectors F301e and F304e both act through the anchorage points of anchor 200e, the resultant force through the anchorage points of anchor 200b is defined as the sum of the two vectors F302b and F303b. You can Correspondingly, FIG. 10C schematically shows the resultant force exerted by the closure element on each anchor. The force applied through anchor 200b is represented by composite vector F302f+F303f, and the force applied through anchor 200e is represented by composite vector F301e+F304e.

Due to the positioning of the anchors 200a, 200b, 200c, 200d, 200e, 200f and the arrangement of the closure elements 301, 302, 303, 304, a higher compression force is applied in the y-axis direction than in the z-axis direction. The z-axis corresponds to a line extending between the first anchor group 200a, 200b, 200c and the second anchor group 200d, 200e, 200f, and 200a, 200b, 200c and the second anchor group 200d, 200e, 200f. At least approximately equidistant from. The y-axis is perpendicular to the z-axis, and both the x-axis and the y-axis extend along the surface of tissue 900.

Since the compressive force is higher in the direction parallel to the x-axis than in the direction parallel to the z-axis, the opening 905 is flattened or elongated along the z-axis, as shown in the closed state of FIG. 10D. As such, the self-actuating closure device formed by anchors 200a, 200b, 200c, 200d, 200e, 200f and closure elements 301, 302, 303, 304 tends to close opening 905. This may be desirable to maintain a more reliable closed condition that is more leak resistant.

As schematically shown in FIG. 10D, anchors 200a, 200b, 200c, 200d, 200e, 200f have been attracted to a closed or approached position, thereby allowing anchored tissue to enter opening 905. Pull toward, which closes opening 905 as shown. For ease of illustration, the closure elements 301, 302, 303, 304 are not shown in Figure 10D. However, FIG. 10E shows the closed state of 10D with the closure elements 301, 302, 303, 304. The forces exerted by the closure elements 301, 302, 303, 304 on the anchors 200a, 200b, 200c, 200d, 200e, 200f are similar to those shown in Figures 10B and 10C. However, the exemplary closure elements 301, 302, 303, 304 have spring-like elasticity so that the closure elements 301, 302 as the anchors 200a, 200b, 200c, 200d, 200e, 200f are attracted toward each other. , 303, 304 may be reduced in force.

In the stationary closed position shown in FIGS. 10D and 10E (ie, the position where anchors 200a, 200b, 200c, 200d, 200e, 200f settle after transitioning from their orientation around working tube 100), each anchor 200a, The force exerted by the closure elements 301, 302, 303, 304 through 200b, 200c, 200d, 200e, 200f causes the anchors 200a, 200b, 200b, 200b, 200c, 200d, 200e, 200f to be anchored by the tissue at each respective anchor 200a, 200b, 200c, 200d, 200e, 200f. Equivalent to the oppositely directed resistance force applied to 200c, 200d, 200e, 200f.

FIG. 11 shows another closure element 1300. The closure element 1300 includes three anchor receiving portions 1310, 1320, 1330 arranged in a V-shape, the portion 1320 being located at the apex. Arm 1340 extends directly from anchor receiving portion 1310 to anchor receiving portion 1320, and arm 1350 extends directly from anchor receiving portion 1320 to anchor receiving portion 1330. The anchor receiving portions 1310, 1320, 1330 each have a respective opening 1312, 1322, 1332 for receiving a respective anchor, for example the anchor 200 described above or the anchor 1200 detailed below in connection with FIG. ing. The anchor receiving portions 1310, 1320, 1330 are each toroidal in shape and have a greater material thickness than the arms 1340 and 1350. However, it goes without saying that any suitable geometry may be provided and any suitable material thickness may be provided. The toroidal shape of the anchor receiving portions 1310, 1320, 1330 couples with the anchors 200, 1200 in a manner similar to the band-shaped closure element 300 described above with respect to the anchor 200.

Closure element 1300 functions similarly to that described above with respect to closure element 300, except that only two closure elements are required to generate the same force as shown in FIGS. 10B and 10C. Specifically, the closure element 1300 performs the same function as the closure element 301, 304 or the two two closure elements 302, 303 of the second V-shaped group described above with respect to FIG. 10A. Further, the closure element 1300 differs in that each of the single structural elements, or arms 1320, extends between opposing anchors.

FIG. 12 shows another closure element 2300. Closure element 2300 includes three anchor receiving portions 2310, 2320, 2330 arranged in a V-shape, with portion 2320 located at the apex. Arm 2340 extends directly from anchor receiving portion 1310 to anchor receiving portion 2320, and arm 2350 extends directly from anchor receiving portion 2320 to anchor receiving portion 2330. The anchor receiving portions 2310, 2320, 2330 each have respective openings 2312, 2322, 2332 for receiving respective anchors. Anchor 2300 includes all of the features described above in connection with anchor 1300, but arms 2340, 2350 are widened to be approximately the same outer diameter as the respective anchor receiving portions 2310, 2320, 2330. Only differ in points. This can be advantageous to provide additional strength and tension when the arms 2340, 2350 are extended.

FIG. 13 shows the anchor 1200. Anchor 1200 is similar to anchor 200 described above except that proximal end 1250 includes circumferential channel 1255. The circumferential channel 1255 is formed as a continuous radial recess that extends around the entire circumference of the anchor 1200. The channel is radially open and includes a distally-oriented first surface 1260 and an opposite proximally-oriented second surface 1265. A surface 1270 corresponding to the reduced diameter portion 1280 of the anchor 1200 extends between the first surface 1260 and the second surface 1265. Although the reduced diameter portion 1280 is cylindrical and coaxial with the longitudinal axis xx' of the anchor 1200, it goes without saying that any suitable geometry and orientation may be provided. For example, the reduced diameter portion 1280 may be frustoconical and/or have a curved cross-section when viewed in a direction perpendicular to the longitudinal axis xx' of the anchor 1200. Further, the surface 1270 of the reduced diameter portion 1280 may vary along the perimeter of the anchor 1200.

The circumferential channel 1255 axially separates the proximal head portion 1285 from the distal remainder of the body of the anchor 1200.

When the one or more closure elements 300, 1300, 2300 are coupled to the anchor 1200, the first surface 1260 causes the one or more closure elements 300, 1300, 2300 to approach the channel 1255. The slide of the anchor 1200 prevents the slide from sliding down from the end of the anchor 1200. Similarly, second surface 1265 inhibits one or more closure elements 300, 1300, 2300 from sliding distally over channel 1255. In this regard, the dimensions of channel 1265, such as the width and depth of channel 1265, are selected to accommodate a particular number of closure elements 300, 1300, 2300, or a single closure element 300, 1300, 2300. May be done.

The particular closure element 300, 1300, 2300 is fitted to the anchor 1200 by mating and placing the anchor 300, 1300, 2300 around the reduced diameter portion 1280 of the anchor 1200. For example, the anchor receiving portion 1310 of the anchor 1300 may be extended by attaching and anchoring the respective anchor receiving portion 1310, 1320, 1330, 2310, 2320, 2330 to the reduced diameter portion 1280 via the proximal head portion 1285 of the anchor 1200. , 1320, 1330 and/or anchor receiving portions 2310, 2320, 2330 of anchor 2300 can be fitted to anchor 1200. When mated in this way, the reduced diameter portion 1280 extends through the respective openings 1312, 1322, 1332, 2312, 2322, 2332 and the anchor receiving portions 1310, 1320, 1330, 2310, 2320, 2330 are channeled. 1255 is constrained between first and second walls or surfaces 1260 and 1265. In this regard, the openings 1312, 1322, 1332, 2312, 2322, 2332 are
It may have a static diameter that is the same as, greater than, or less than the diameter of the reduced diameter portion 1280. However, to resist inadvertent engagement disengagement of the closure elements 1300, 2300 from the anchor 1200, it provides a smaller static diameter than the first surface 1260, the second surface 1265, and/or the proximal head portion 1285. It may be advantageous in some cases.

The channel 1255 performs a function similar to that of the hook-like portion 210. Anchor 1200 does not include a hook-like portion, such as hook-like portion 210 of anchor 200, but, needless to say, one or more hook-like portions may be provided in combination with the channel arrangement of anchor 1200. May be.

14 shows the plurality of anchors 1200 of FIG. 13 and the closure element 2300 of FIG. 12 when the holes 1905 of the tissue 1900 are closed. Similar to the example described above with respect to anchor 200, individual instances of anchor 1200 are shown in lower case. In this regard, anchors 1200a, 1200b, 1200c, 1200d, 1200e, and 1200f are arranged in the same configuration as described above for anchors 200a, 200b, 200c, 200d, 200e, and 200f, And apply the same force to each. The axes yy and zz in FIG. 14 correspond to the axes y and z.

In FIG. 14, there are first and second cases of the closure element 2300. The second case is distinguished by a trailing letter "'" (prime) in a similar sign. Compared to the overlapping V-shaped arrangement shown in FIG. 10A, arm 2350 of FIG. 14 performs a similar function to closure element 301 and arm 2340′ performs a similar function to closure element 302. 2350′ performs a similar function to closure element 303, and arm 2340 performs a similar function to closure element 304. Furthermore, similar to the arrangement of Figure 10A, the two V-shaped arrangements are both overlapping and interlocking. That is, when viewed along a line perpendicular to the surface of the tissue 900, 1900, each V-shaped array of each configuration has a first extension that intersects the proximal side of each opposing V-shaped configuration and a respective A second extension intersecting at the V-shaped distal side. Thus, referring to FIG. 10A, with respect to the surface of tissue 900, closure element 302 overlaps closure element 301 and closure element 304 overlaps closure element 303. Similarly, referring to FIG. 14, arm 2340' overlaps arm 2350, and arm 2340 overlaps arm 2350'. However, it goes without saying that other forms may be provided.

FIG. 15 shows a surgical closure device 1005 according to a preferred embodiment of the present invention. Unless otherwise noted, surgical closure device 1005 includes features that are the same as or similar to all of the features of surgical device 5 detailed above. Furthermore, the features described with respect to surgical closure device 1005 may be provided in combination with any of the features of surgical closure device 5.

Surgical closure device 1005 includes a handle 1010 that includes a pistol grip 1015. The pistol grip is configured to be held by an operator, such as a surgeon or an intervenor, for operating the surgical closure device 1005 during a surgical procedure. A shaft 1020 extends distally from the handle 10 and includes a distal end 1025. Unlike surgical closure device 5, surgical closure device 1005 does not at least initially include an outer working tube or a cannula extending within the outer working tube. Instead, surgical closure device 1005 includes a centering mechanism 1800 in the form of an elongated tubular shaft with a distal portion 1805. Distal portion 1805 is tapered to reduce the diameter at the distal end of centering mechanism 1800. An inner guide hole 1810 extends along the longitudinal axis of the centering mechanism 1800 from the distal end 1815 to the proximal end 1825 of the centering mechanism 1800. When the device is assembled in the condition shown in FIG. 15, the longitudinal axis of the centering mechanism 1800 corresponds to the longitudinal axis x'of the shaft 1020.

The centering mechanism 1800 may be particularly advantageous during "over the wire" surgical procedures such as pericardial puncture. Some pericardiocentesis may be performed by inserting the needle through the patient's intercostal opening. This involves inserting the pericardium into the patient's thoracic cavity, guiding the guidewire through the needle, and subsequently removing the needle leaving the guidewire in place. The dilator can be advanced over the guidewire to dilate the opening in the pericardial tissue. The dilated opening, or tube, provides room for the catheter. The fluid is drained from the pericardium by guiding it into the pericardium.

With reference to device 1005, after the flexible guidewire is positioned at the desired location within the pericardium and the needle is retracted, the free proximal end of the guidewire is introduced into the distal opening of guide hole 1810, and The guidewire is generally extended through the guide hole 1810 until it extends from the proximal end 1820. The device 1005 is then guided into the patient's body to the location of the pericardial tissue by sliding distally along a guidewire extending through the guide hole 1810. Once the distal end 1025 of the shaft 1020 is positioned to abut the tissue, the six anchors 1200 are driven and pushed into the tissue in much the same manner as described above for the anchors 200.

Referring to FIG. 16, anchor 1200 is mated with two overlapping closure elements 1300, similar to those described above. In contrast to the closure element 300 of the device 5, the closure element 1300 is not held radially outward on the surface of the tube or other structure during actuation of the anchor 1200. Rather, the closure element 1300 forms an operating window 1060 through the overlapping V-shaped structure of the closure element 1300. The overlapping V-shaped structures are detailed above with respect to closure elements 300, 2300.

When the guide wire is threaded through the guide hole 1810, the centering mechanism 1800 including the guide hole 1810 extends through the manipulation window 1060 so that the anchor is driven on the guide wire 1810, as well as any instrument passing over the guide wire 1810. After that, it is guaranteed to extend through the operating window 1060.

As shown in FIG. 16, tension applied to the elastomeric closure element 1300 will cause the anchor receiving portions 1310, 1320, 1330 to stretch and elastically deform. In this way, the vertices of the V-shaped portion move so as to approach each other. Further displacement of the vertices causes the anchors 1300 to each have a Y-shape as shown in FIG.

After the anchor is driven and pushed into the tissue, the centering mechanism 1800 is separated from the rest of the device 1005 and slides away from the surgical site along the longitudinal axis x′ and along the guide wire. By doing so, it is pulled in to the distal side. Centering mechanism 1050 can be removed by an operator by pulling proximal knob 1057, which projects proximally from handle 1010, proximally.

When the guide mechanism 1050 is removed, the guide wire exits the guide hole 1810. The proximal free end of the guidewire can then be handed into a tapered dilator. The dilator can be guided along the guide wire and through the shaft 1020 to the operating window 1060. The dilator can then proceed further to contact and dilate the tissue tract through which the guide wire extends. After expansion, the dilator can be retracted proximally and disengaged from the guidewire. At that stage, the catheter can be advanced and advanced along the wire through the shaft 1020 and operating window 1060. The catheter is further advanced into the pericardium through the expanded tissue opening. At this stage, the guide wire can be withdrawn, allowing the pericardial fluid to drain through the catheter.

Once drained, the catheter can be withdrawn proximally through the shaft 1020 from the surgical site. At this stage, there are no surgical components extending through the expanded opening. At this stage, device 1005 can be withdrawn proximally from the tissue. Pulling the distal end of the shaft 1020 from the tissue disengages or disengages the anchor 1200, allowing the closure element 1300 to pull the anchor 1200 together similar to that shown schematically in FIG. This closes the opening in the same manner as opening 1905 is closed in FIG.

Referring to the inset view of FIG. 15, the distal end 1025 of shaft 1020 includes six slots 1026 similar to slots 26 described above in connection with device 5. In the inset view, anchor 1200 is shown schematically to facilitate the illustration of other components of device 1005.

Referring to FIG. 16, the slot 1026 of the device 1005 has a cross-sectional shape similar to the slot 26 of the device 5, which cross-sectional shape allows a small void between the diameters of the main body of the anchor 1200. Includes a circular ridge sized to correspond to circular groove 1027.

A narrowed portion 1028 extends from opposite sides of the enlarged region 1029 formed by the cylindrical groove 1027. The narrowed portion 1028 is formed to receive the split portions 1207, 1208 of the anchor 1200, but is narrower than the diameter of the body 1201 of the anchor 1200 so that the anchor 1200 is within the enlarged region 1029 of the circular groove 1027. Guaranteed to be bound by. Thus, when received within the slot 1026, the anchors 1200 are retained in their axial alignment so that the longitudinal axis xx' is aligned with the longitudinal axis x'of the shaft 1020.

The end 1025 is formed as a separate piece attached to the rest of the shaft 1020. In this regard, the end 1025 can be replaced with a similar end 1025, or an end 1025 having a different configuration, eg, an end holding the anchors in a different pattern. For example, the end 1025, together with the anchor and closure element, forms a cartridge that can be used once and discarded, and a new cartridge can be attached for further treatment. Further, it should be appreciated that the end 1025 may be integrally formed as a single piece with the rest of the shaft 1020.

Surgical closure device 1005 uses a drive mechanism similar to that of device 5, including a hammer sleeve and anvil pin (obscured by shaft 1020 in FIG. 15), but device 1005 has different trigger and Including safety mechanism.

Referring to FIG. 15, the device 1005 includes a trigger 1030 extending below the housing 1010 in substantially the same direction as the pistol grip 1015, as described in detail below when an operator, eg, a surgeon, grasps the pistol grip 1015. By pulling the grip portion 1031 exposed from the housing 1010 proximally in order to pivot the trigger 1030, the trigger 1030 can now be actuated by the operator's finger, for example the index finger and/or the middle finger. There is.

15 and 17-19, the trigger 1030 is pivotable with respect to the handle 1010 about a pivot axis p. Pivot axis p corresponds to the longitudinal axis defined by pivot pin 1040 to which trigger 1030 is attached. Specifically, pivot pin 1040 extends within a corresponding hole 1032 of trigger 1030. This is shown, for example, in Figure 18C. The axial end of pivot pin 1040 is mounted in a corresponding recess in handle 1010.

Trigger 1030 includes a pair of flat surfaces 1033. These planes are separated from each other in opposite directions along the pivot axis p. The flat surface 1033 extends along the area of the trigger around the hole 1032 and extends proximally along the proximal arm 1033.

The proximal arm 133 extends proximally with respect to the pivot axis p and has a curved upper surface 1034. A lateral projection 1036 extends from each lateral side of the proximal arm. The lateral projections project outward from their respective flat surfaces 1031 and extend generally parallel to the swivel axis p. The lateral projections 1036 each have a curved upper surface 1037.

Latch member 1045 includes a laterally disposed portion 1050 disposed distally. When the device is assembled, the lateral portion 1050 extends generally along the pivot axis p and transverse to the longitudinal axis x'of the shaft 1020. A pair of parallel arms 1055 extend proximally from the lateral portion 1050. Each of the parallel arms 1055 includes a hole 1056 formed to receive the pivot pin 1040 and a pair of opposing surfaces 1057 formed to receive the trigger 1030 therebetween, thereby allowing the device 1005 to operate. When in the assembled condition, each outwardly facing surface 1033 of the trigger 1030 faces a respective one of the inwardly facing surfaces 1057 of the arm 1055. When the trigger 1030 is received between the arms 1055 of the latch element 1045 in the assembled state of the device 1005, the hole 1056 becomes coaxial with the hole 1032 of the trigger 1030 and the pivot pin 1040 causes the two holes 1056 of the arm 1055. , And through each of the holes 1032 of the trigger 1030, which provides a mechanism by which the trigger 1030 and the latch element 1045 can pivot about their common pivot axis p. Accordingly, the latch member 1045 engages the trigger 1030 at the pivot pin 1040 in a manner similar to a clevis. The trigger 1030 and the latch element 1045 pivot about a single common axis p, but it goes without saying that the trigger 1030 and the latch element 1045 may pivot about separate axes.

The portion of arm 1055 extending proximally from common axis p includes a lower surface 1058 configured to engage an upper surface 1035 of proximal arm 1034 of trigger 1030. Therefore, when the trigger is pulled proximally, the trigger pivots about the common axis p in the first rotation direction CW. The first rotation direction CW is the clockwise direction when viewed from the side shown in FIG. 17B.

The lateral portion 1050 of the latch member 1045 also includes a latching lug 1052. The latch engagement projection 1052 projects upward beyond the structure adjacent to the latch member 1045.

Referring to FIG. 19A, a driver in the form of a hammer sleeve 1500 is in a preloaded proximal position and is driven by a drive spring 1550 (shown in FIG. 17A) similar to hammer sleeve 500 of device 5. It is propelled or biased distally. The drive spring 1550 is coaxially mounted to the hammer sleeve 1500 and the shaft 1020 and is distally directed to the hammer sleeve 1500 via a force transmitting flange 1560 that extends circumferentially around the hammer sleeve 1500. Add force. Although the drive springs 550 and 1550 described in connection with devices 5 and 1005 are formed as compression springs, it goes without saying that tension springs or other drive mechanisms may be provided.

Hammer sleeve 1500 includes a latch engagement channel 1510. Latch latch channel 1510 immobilizes hammer sleeve 1500 by receiving latch latch protrusion 1052, thereby forming a positive stop between latch latch protrusion 1052 and latch latch channel 1510. To do. To release the hammer sleeve to drive the anchor 1200 in a manner similar to that described in connection with the device 5, the trigger is pulled distally, thereby triggering in the first rotational direction CW about the pivot axis p. To turn. Such a swivel orientation is shown in Figure 19B.

As shown in FIG. 19B, rotation of the trigger 1030 causes the lateral projection 1036 to contact and push against the lower surface 1058 of the arm 1055, thereby causing the latch member 1045 to be in its trigger position, ie, shown in FIG. 19B. Rotate it to the right position. In the trigger orientation of the abduction member 1045, rotation of the latch member 1045 disengages the distally located latch latching projection 1052 from the latch latching channel 1510 of the hammer sleeve, which causes the hammer sleeve to engage the shaft 1020. It can be driven in the distal direction D along the longitudinal axis x′, which drives the anchor 1020.

As shown in FIG. 1, there are two safety mechanisms that prevent release of the hammer sleeve 1500 by the latch member 1045. In order for the device to drive the anchor 1200, both of these safety mechanisms must be disengaged or changed from the locked state to the unlocked state at the same time.

The first safety mechanism includes a pressure sensing mechanism including, for example, a spring loaded contact element 1100 shown in the inset partial view of FIG. The contact element 1100 is formed as a rectangular block. These blocks are in the extended position shown in the inset view of FIG. 15, i.e. in the extended position in which the contact element 1100 extends beyond the distal end face of the shaft 1020, for example in the contact element 1100 at the distal end of the shaft 1020. The contact element 1100 slides along the longitudinal axis x'of the shaft 1020 between a proximal position in which the contact element 1100 is pushed proximally relative to the shaft 1020 until flush. The safety release mechanism may include a plurality of spring loaded members, each spring loaded member being independently movable between an engaged position and an disengaged position. The safety release mechanism is configured to prevent the driver from driving the anchor unless all of the spring loaded members are in the engaged position.

Each contact element 1100 is axially slidable within a correspondingly sized slot 1080 shown in FIG. 16, for example. The illustrated example includes four rectangular contact elements, even though they are evenly spaced about the longitudinal axis x'of the shaft 1020 in increments of approximately 90 degrees. Of course, any suitable number of contact elements 1100 (including one) having any suitable geometry and located at any suitable location may be provided.

Each contact element 1100 is supported by a respective pressure transmission shaft 1120. The pressure transmission shaft 1120 is axially slidable within a respective hole 1085 extending parallel to the longitudinal axis x'of the shaft 1020. Each pressure transmission shaft 1120 is proximally coupled to a key member 1140. The key member 1140 extends into and engages the key plate 1160, as shown in FIG. 17A. One or more springs exert a spring force on the key member 1140 to urge or bias the contact elements 1100 toward their distal extended position.

When the distal end of shaft 1020 is pressed against the tissue that anchor 1200 is desired to be driven through, the tissue exerts a proximally directed pressure on contact element 1100. Contact element 1100 is initially in a distally extended position due to spring loading. When the pressure exerted by the tissue exceeds the spring bias or thrust, the contact element is pushed proximally with respect to the shaft 1020. Such proximal movement within each slot 1080 is mechanically transmitted to the key element 1140 via the respective pressure transmission shaft 1120, which causes the key member to extend proximally beyond the key plate 1160. Move to. In this regard, there is an approximately 1:1 relationship between the axial movement of each contact element 1100 and respective key member 1140. However, it should be understood that the device may be configured such that the relationship between the axial movement of the key member 1140 and the axial movement of the respective contact element 1100 is other than 1:1. Further, while the exemplary apparatus 1005 utilizes a sliding shaft 1120 to mechanically couple and transmit force from the contact elements 1100 to respective key members 1140, the contact elements may be coupled to other mechanisms, such as a liquid. It may be mechanically coupled to the key member 1140 by a pressure and/or pneumatic system.

The key plate 1160 can slide within the handle 1010 along an axis transverse to the longitudinal axis x'of the shaft 1020 and a pivot axis p defined by the pivot pin 1040. In this regard, the key plate 1160 can slide between the first position shown in FIG. 17A and the second position shown in FIGS. 18B and 19A. The movement of the key plate 1160 between the first position and the second position is along a path lying in a plane substantially perpendicular to the pivot axis p. Referring to FIG. 19B, the key plate 1160 moves in the direction U to move from the first position to the second position. Although the passage through which the key plate 1160 moves between the first position and the second position is linear, it goes without saying that the passage may be non-linear, for example, curved. Further, when the key plate 1160 moves from the first position to the second position, the plane including the turning axis p and intersecting the bottom surface 1161 of the key plate 1160 rotates in the first rotation direction CW. Similarly, when the key plate moves from the second position to the first position, this plane rotates in the second rotation direction opposite to the first rotation direction CW.

The key plate 1160 is slidably supported by a proximal support block 1090 fixedly mounted within the handle 1010 of the device 1005. In the illustrated example, the key plate 1140 is supported by the pair of parallel guide ribs 1092 of the support block 1090, so that the key plate 1160 can slide between the first position and the second position. The support block 1090 also supports each of the key members 1140 so that each of the key members 1140 can slide along the longitudinal axis f, g, h, i of the respective shaft 1140 to which the key member 1140 is mounted. You can Thus, the key member 1140 is allowed to slide axially along the axes f, g, h, i, but with respect to the handle 1010, the shaft 1020, and other fixed components of the housing of the device 1005. Movement is restricted.

If any one of the key members 1140 is still engaged with the plate, this means that one of the contact elements 1100 at the distal end of the shaft 1020 has not been fully pushed down proximally. However, in such a case, the geometry of the key plate 1160 is selected to prevent the key plate 1160 from moving to the second position.

The geometry of the key plate 1160 is configured to allow each of the pressure transmission shafts to pass through the key plate 1160 when the key plate is in either the first position or the second position. However, the geometry of the key plate 1160 does not allow any of the key members 1140 to extend axially into any recess defined by the key plate 1160 when the key plate 1160 is in the second position. .. In the illustrated example, this means that the diameter of each key member 1140, viewed along a line parallel to the direction of movement of the plate 1160, is greater than the diameter of the respective pressure transmission shaft 1120 to which the key member is coupled. Is also achieved based on the fact that it is also great.

18A-18E, the key plate 1160 has a complex cutout geometry that includes an enlarged region 1165 configured to axially receive a respective key member 1140. Referring to FIG. 18A, when the key plate 1160 is in the first position, the structure of the key plate 1160 and the longitudinal axes f, g, h, i of the four respective pressure transmission shafts 1120 pass through the key plate 1160. The space between each enlarged region 1165 is sufficient to axially receive the key member 1140. Referring to FIG. 18B, when the key plate 1160 is in the second position, the gap between the structure of the key plate 1160 and the respective regions 1170 through which the longitudinal axis of the pressure transmission shaft 1120 passes through the key plate 1160 is: It is insufficient to axially receive the key member 1140, but quite enough to allow the pressure transmission shaft 1120 to pass through.

As shown in FIG. 18C, the geometry of each key member 1140 is received within a closely fitting corresponding recess in the key plate 1160 so that the key plate 1160 (see, for example, FIGS. 18C and 18D). ) It is not possible to move in the direction U from the first position to the second position (for example shown in FIG. 18E). With reference to FIG. 18D, all four key members 1140 have been pushed down proximally by pushing down the corresponding contact element 1100 at the distal end of the shaft 1020, which causes the keys to fall. The plate is disengaged from the key member 1140. As shown in FIG. 18D, the key member 1140 has overcome the structure of the key plate 1160 proximally, while the key plate 1160 is in the first position. At this stage, the region 1170 of the key plate 1140 can receive the shaft 1120. The shaft is reduced in diameter with respect to each key member 1140 to which the shaft 1120 is attached. Therefore, the key plate 1140 is in the unlocked state. This is because it can move in the U direction from the first position shown in FIG. 18D to the second position shown in FIG. 18E. As mentioned above, this movement is accomplished by contacting and exerting a force between the upper surfaces 1035 of the proximal extensions 1034 of the trigger 1030.

The key members 1140 are radially constrained within the handle 1010 such that when any one or more of the key members 1160 is extended into the cutout geometry of the key plate 1160, the key plate 1160 will not You are prevented from moving into position. Thus, if any one of the contact elements 1100 is not fully depressed, the first safety mechanism is in the locked state and engages at least one of the key members 1140 and the key plate 1160.

Referring again to FIG. 19A, since the key plate cannot move from the illustrated first position in the locked state, contact between the top surface 1035 of the proximal arm 1034 of the trigger 1030 and the bottom surface 1161 as the trigger 1030 results. , A positive stop is formed, which prevents the trigger 1030 from rotating sufficiently to disengage and disengage the latch member 1045 from the hammer sleeve 1500. Therefore, in order for device 1055 to drive anchor 1200, all four contact elements 1100 must be depressed. This safety mechanism requires that the distal end of shaft 1020 be properly seated in tissue prior to driving anchor 1200, thereby reducing the likelihood of accidental or improper actuation of anchor 1200. It is advantageous.

As shown in FIG. 17, the key plate 1160 is urged by the spring 1162 toward the first position. Since the operator may need to reposition the distal end of the shaft 1020 before actuating the anchor 1200, a spring that propels or biases the contact element 1100 toward the first position causes the contact element 1100 to Guarantees a spring-elastic return to the extended position. For example, the operator may press the distal end of shaft 1020 against the first tissue portion to fully depress all four contact elements 1100, thereby removing all four key members 1140 from key plate 1160. Move to the proximal side. At this stage, the first safety mechanism is in the disengaged state to allow firing when the operator pulls the trigger 1030. Therefore, the key plate 1160 is slidable between the first position and the second position. If there is no propulsion of the key plate 1160 toward the first position, the key plate 1160 may prevent the key member 1140 from re-engaging the key plate 1160 (eg, the second position, or the first and second positions). There is a risk of inadvertently sliding to a position between the positions). Thus, even if the operator repositions device 1005, for example, by pulling the distal end of shaft 1020 away from the first tissue portion, the first safety mechanism remains disengaged, And the contact elements 1100 are not returned to their distal extended position via the biasing spring force. Therefore, the first safety mechanism is not effective at this stage. Since spring 1162 acts to propel key plate 1160 toward its first position, the spring may reposition the distal end of shaft 1020 multiple times without overriding the first safety mechanism. To help ensure that.

The housing 1010 includes a window 1013. The window 1013 provides a visual indication to the operator as to the status of the contact element 1100. For example, there may be four discrete indicators corresponding to each contact element 1100. Thus, the operator can see that less than all four contact elements 1100 are depressed and continue to operate the device until all four contact elements 1100 are depressed. Furthermore, the indicator allows the operator to know which particular contact element 100 is not depressed, so that the operator can operate the device 100 accordingly.

Although the pressure sensing of device 1005 is purely mechanical, it goes without saying that other pressure sensing devices may be provided. For example, an electronic pressure sensor may be provided.

The second safety mechanism includes a safety switch 1060. As shown in FIGS. 19A and 19C, safety switch 1060 is in the first position. In the first position, the first surface 1062 of the safety switch 1060 forms a positive stop against the bottom surface of the latch member 1045, causing the latch member 1045 to rotate about the pivot axis p and engage as shown in FIG. 19B. Prevent entry into dissociation position.

The safety switch 1060 is slidably mounted inside the corresponding hole of the handle 1010. As shown in FIGS. 19B and 19D, the safety switch 1060 is slidable about its longitudinal axis s between a first position relative to the latch member 1045 and a second position relative to the latch member 1045. In this regard, the first axial end 1066 is exposed from the first side of the housing 1010 and the opposite axial end 1068 is exposed from the second side of the housing 1010. The operator can move the safety switch from the first position to the second position by pushing the first axial end 1066 along the axis s. Similarly, the operator can move the safety switch from the second position to the first position by pushing the second axial end 1068 along the axis s.

In the second position, the first surface 1062 has moved along the axis s to a position that does not hinder the rotation of the latch member 1045. Accordingly, the latch member 1045 is free to rotate to the second position, which releases the hammer sleeve 1500 and drives the anchor 1200. Thus, the second safety mechanism is engaged when the safety switch is in the first position and disengaged when the safety switch is in the second position.

The second surface 1064 forms a positive stop to prevent the latch member 1045 from rotating beyond the second position in the CW direction.

As noted above, both safety mechanisms must be disengaged from device 1005 to drive anchor 1200. The first safety mechanism ensures that the distal end of the shaft 1020 is properly seated in the tissue and the second safety mechanism prevents unintentional firing due to inadvertent pulling of the trigger 1030. In this regard, the operator may wish to leave the second safety mechanism engaged until satisfied with the placement of the distal end of shaft 1020.

Although the first and second safety mechanisms in the illustrated example are mechanical as a whole, it goes without saying that other mechanisms may be provided. For example, an electronic element may be incorporated into the system, and/or a particular force or pressure value at the contact element location may be interpreted by the processor to determine, for example, according to an algorithm, whether the anchor 1200 may be actuated. You can

Referring to FIG. 17A, the handle 1010 is formed as two corresponding injection molded halves. One of the halves is shown in Figure 17A. Each half of the handle 1010 includes various structures configured to receive and support other components within the handle 1010. For example, a plurality of support ribs 1012 mate with respective corresponding pairs of support slots 1012 in shaft 1020 to secure shaft 1020 to handle 1010 when the device is assembled. In the assembled state, the first and second halves are joined by the anchor 1011. These anchors are screws in the example shown. Although an injection molded handle is provided that has two halves joined together, it should be understood that handle 1010 may be formed in any suitable manner.

According to a preferred embodiment of the present invention, the closure element includes a tissue compression band 330 attached to either end of anchor 3200. Referring to FIG. 21A, the tissue compression band 330 is shown in a relaxed (no force applied or minimal force applied) condition. Anchors 3200 are attached to both ends of tissue compression band 3300. Thus, in contrast to other embodiments of the invention in which the anchors may be coupled to two or more other anchors, in this preferred embodiment, each anchor 3200 is separated by a tissue compression band 3300. Of the anchor 3200. This preferred embodiment, and its advantages, are detailed below.

Anchor 3200 includes wings 3207 and coupling element 3210. 21A-21E, wing 3207 has a relaxed, uncompressed position and, together with anchor 3200, forms a shoulder. In this shoulder, wings 3207 extend proximally and radially outward from the distal end of anchor 3200, or are more distal than the distal end. 21A-21E, the airfoil 3207 includes a radially outer surface and a radially inner surface. The radially outer surface described above in connection with FIG. 4 may include longitudinally extending folds. The folds can provide a plurality of elongated protrusions at the free end of the airfoil. The radially inner surface may be concave.

Referring to FIG. 21B, which is a cross-sectional view of tissue compression band assembly 3000, each end of tissue compression band 3300 terminates within cavity 3211 of anchor 3200. The wings 3207 of the anchor 3200 project radially away from the axis of the anchor 3200 beyond the cavity 3211 in a direction away from the distal tip of the anchor 3200. Thus, wing 3207 forms a separation between anchor 3200 and tissue compression band 3300.

21C-21D, a coupling element 3210 is used to secure each end of the tissue compression band 3300 within the cavity 3211 of the anchor 3200. The end 3310 of the tissue compression band 3300 may include a protrusion 3311 such that the end 3310 has a larger radius than the main portion of the tissue compression band 3300 and a larger radius than the inner portion of the coupling element 3210. It is like this. The protrusion 3311 and the coupling element 3210, when placed within the cavity 3211 of the anchor 3200, serve to maintain a mechanical coupling between the tissue compression band 3300 and the anchor 3200.

21E, a tissue compression band assembly 3000 including an anchor 3200 and a tissue compression band 3300 is shown. Although each anchor 3200 is shown as including two wings 3207, any number of wings may be provided. As shown in FIG. 21E, the tissue compression band 3300 is coupled to each of the two anchors 3200. The anchor 3200 is arranged at a predetermined angle with respect to the axis of the tissue compression band 3300 so that the tissue compression band 3300 can be bent near each end inside the coupling portion with the anchor 3200. There is. The tissue compression band 3300 can pass through the space between the two wings 3207. In this position, the tissue compression band assembly 3000 will be positioned within the surgical closure device 5 prior to implantation with the anchor 3200 positioned at an angle to the axis of the tissue compression band 3300. ..

Referring to FIG. 22, a front view of the end 3025 of the device 5 including four tissue compression band assemblies 3000 is shown. Each tissue compression band assembly 3000 is represented as shown in FIG. 21E, with each anchor 3200 positioned at an angle with the axis of the tissue compression band 3300 and positioned within slot 3026. ing. The tissue compression band 3300 forms a cross pattern over the central region of the end 3025. The central region is targeted to the opening 3905 of the tissue 3900 as described below.

FIG. 23 is a perspective view of the end 3025 of the device 5. The tissue compression band assembly 3000 is shown loaded onto the pusher pin 3600. Pusher pin 3600 is shown in this figure as extending beyond the end of end 3025.

The distal end of the device 5 may further include a window and a constriction element. Prior to ejecting the anchor 32300 from the distal end of the device 5, the wings 3207 of the anchor 3200 can be expanded to a relaxed first position so that the wings do not compress. During ejection from device 5, anchor 3200 can face the constriction element, which allows the constriction element to compress the airfoil to the second compression position. Once the anchor is ejected from the device 5, the airfoil can expand and return to its relaxed, uncompressed position.

24 and 25, pusher plate 3500 includes pusher pin 3600 having fingers 3610 for acting on tissue compression band assembly 3000. Finger 3610 faces anchor 3200 at coupling element 3210. The fingers 3610 can also face the anchor 3200 at the shoulder. In the shoulder, wings 3207 extend proximally and radially outward from the distal end of anchor 3200 or are more distal than the distal end. Finger 3610 contacts anchor 3200 near the distal tip such that wings 3207 extend beyond the point of contact between finger 3610 and anchor 3200. The delivery mechanism or driver can drive the anchor by applying a driving force to the shoulder to drive the anchor and force it into the tissue.

The use of the tissue compression band assembly 3000 to close the opening 3905 of the tissue 3900 is described below. 26A-26D, tissue 3900 is shown having an aperture 3905. A tissue compression band assembly 3000 having a tissue compression band 3300 and an anchor 3200 is shown without the surgical device 5 for convenience. Tissue compression band 3300 joins two anchors 3200, and wings 3207 extend beyond the coupling point between tissue compression band 3300 and anchor 3200. In FIG. 26A, the tissue compression band assembly 300 is shown in its relaxed (unforced or minimally applied) state and is positioned at a distance from the tissue 3900. .. In FIG. 26B, the distal tip of anchor 3200 has been pushed through the surface of tissue 3900 on either side of opening 3905. The anchor 3200 has only penetrated the tissue 3900 to the extent of the distal tip and has not yet penetrated beyond the coupling element 3210 so that the wing 3207 remains outside the surface of the tissue 3900.

In FIG. 26C, anchor 3200 has now penetrated tissue 3900 at a depth equal to the height of anchor 3200. Wings 3207 are now just inside tissue 3900 on either side of opening 3905. While the tissue compression band 3300 remains largely above the surface of the tissue 3900, both ends of the tissue compression band 3300 have penetrated the surface of the tissue 3900 by the anchors 3200, so that the tissue compression band 3300 is not attached to the tissue 3900. They become nervous and enter a tension (that is, forced) state. Finger 3610 of pusher pin 3600 remains in contact with anchor 3200. As the anchor 3200 is pushed into the tissue 3900, the tissue compression bands 3300 force the sides of the opening 3905 closer together, reducing the size of the opening 3905.

In FIG. 26D, the anchor 3200 has now been pushed a predetermined distance below the surface of the tissue 3900, pulling the tissue compression band 3300 away from the surface of the tissue 3900, pulling the sides of the opening 3905 together, until the opening is closed. Push to get closer. Finger 3610 of pusher pin 3600 is retracted, leaving tissue compression band assembly 3000 within tissue 3900. As the tissue compression band 3300 tensions against the tissue 3900, the tissue compression band acts on the anchor 3200, pulling the anchor in a direction opposite the insertion direction. The wings 3207 resist this proximal movement and hold the anchor 3200 in place, as described above, which keeps the tissue compression band 3300 in its taut (ie forced) state, That holds the closed opening 3905. Such closure of the tissue remains hemostatic.

The measures described herein provide several advantages. For example, since the tissue compression band assembly 3000 can be loaded into the surgical device 5 in a relaxed state, the device is more easily stored and shipped, which may cause the assembly to wear, fail, or be injured. Is reduced. The assembly enters its tensioned state only when anchor 3200 penetrates tissue 3900.

Further, the tissue compression band assembly 300 can have a lower mass than the closed implant. Since the anchor body is significantly shorter than other configurations, less material is required for anchor 3200. A longer body is not required as the tissue compression band 3300 couples to the anchor 3200 just inside the distal tip, instead of coupling to the end of the longer proximal body. The tissue compression band 3300 includes a small protrusion 3310 for mechanical coupling with the anchor 3200, thus forming a tissue compression band rather than a similar closure device that generally wraps around the proximal end of the anchor. Less material needed to do it. The low mass of the assembly allows it to more highly follow any movement of the tissue 3900, so that the hemostasis achieved on initial application is more susceptible to such movement. This is extremely important in certain organs, such as the heart, where movement is expected and cannot be prevented. Tracking the movement can also be achieved on the basis of the reduced mass and thus the reduced momentum.

The location of attachment of tissue compression band 3300 and anchor 3200 below the surface of tissue 3900 creates a more rounded diagram of the forces acting on tissue 3900 and opening 3905. The force from the anchor acting on the assembly is located below the surface of the tissue, partly pulling the compression band downwards. Such a force distribution may prevent tissue strangling that may result from a closure device that simply applies force parallel to the surface of the tissue. A more rounded force distribution can help maintain hemostasis within the tissue and improve hemostasis.

In general, this configuration allows a higher degree of tracking of any movement of tissue 3900. Following the tissue 3900 is a force acting in the x direction (ie, proximal to the wing 3207 embedded in the tissue) and a y direction (ie, along the length of the tissue compression band 3300, transverse to the aperture 3905). Maintained by equilibrium with the forces acting on. Maintaining such a balance between these forces helps maintain hemostasis in the tissue. Thus, the position of the anchors in the x-direction (ie depth within tissue) or the y-direction (ie distance between anchors) is important to enable such equilibration. The force acting in the y direction is greater than or equal to the force acting in the x direction and may be up to twice that. As an example, the tissue compression band 3300 may be 13 mm long in the relaxed state and may be stretched to a 26 mm length in the tensioned state.

The finger 3610 can push the anchor 3200 to a predetermined depth for optimal purchase and tension to optimize balance and achieve hemostasis in the tissue.

Additional configurations for the distribution of tissue compression band assemblies are shown in Figures 27A-27E. FIG. 27A shows a grid-shaped or box-shaped array. 27B-27D show a circular array of anchors having a grid-like or box-like band configuration at different intervals. FIG. 27E shows a circular array of anchors with five tissue compression bands. FIG. 27F shows a grid or box-like array with five tissue compression bands. Of course, any number of tissue compression bands may be used. Moreover, force balance is reached by the proper distance between the anchors and the proper depth of insertion into the tissue.

Additional configurations for the distribution of tissue compression band assemblies are shown in Figures 28A-28C. Two rows of opposing anchors may be provided and four tissue compression bands extend across these rows to diametrically join the anchors. Of course, any orientation of the tissue compression band assembly may be used.

The larger the tissue opening, the more closure elements are required. Therefore, the predetermined arrangement is intended for the closure of large holes.

A preferred embodiment of the large hole closure plate assembly 4000 is shown in FIGS. 29A and 29B. The closure plate assembly includes an anchor 200 coupled to a closure plate 4300. The closure plate 4300 may be a circular disc with a central hole. The anchor 200 is coupled to the closure plate 4300 around the plate using a coupling element 4310. All anchors 200 extend in the same direction, parallel to the axis of the closure plate. In this form, the closure plate 4300 is a rigid plate and has a defined shape that is used to hold the tissue in place precisely. The large hole closure plate 4300 shown in FIG. 29C may be configured as a disc with an aperture 4320 around it, whereby the closure plate 4300 is coupled to two concentric annular discs via a coupling element 4310. It's similar to. This arrangement has the advantage of using less material and having less mass.

Alternatively, the anchor 200 can be coupled to the closure plate 4300 using a hinged coupling element 4330 (as shown in FIGS. 29D and 29E), which allows the anchor 200 to be close to the anchor 200. It is possible to rotate about the axis formed by the perimeter of the closure plate 4300 facing the proximal end.

Another arrangement of large hole closure plate assemblies allows for additional movement of the closure plate. For example, as shown in FIGS. 30A and 30B, large hole closure plate assembly 5000 includes a sliding closure plate 5300 formed from two sliding braces 5350 and 5360. The sliding braces 5350 and 5360 form a semicircle. The semi-circle has sliding racks 5351, 5361 located on one of the two open ends of the semi-circle, respectively. The sliding rack 5351 is inserted into the complementary cavity of the sliding brace 5360, and the sliding rack 5361 is inserted into the complementary cavity of the sliding brace 5350 so that the two sliding braces face each other and the circular sliding closure plate. 5300 is formed.

Sliding closure plate 5300 further includes anchor 200. Anchors may be used as described above to support closure elements 5301, 5302, 5303, 5304. The closure element may be a band, an integral V-shaped element, or other similar element described herein. Closure elements 5301-5304 are used, for example, to keep sliding closure element 5300 closed (i.e., holding sliding braces 5350, 5360 together). Although the closure plate has some freedom of movement in the direction of the sliding racks 5351, 5361, the large hole closure plate assembly 5000 is held firmly and exerts a force on the anchor 200, thereby joining tissue. To close the large hole opening.

Another preferred embodiment of a large hole closure plate assembly with some freedom of movement of the closure plate is shown in Figures 31A-31C. The large hole closure plate assembly 6000 includes a sliding closure plate 6300 formed from two sliding braces 6350 and 6360. The sliding braces 6350, 6360 have sliding racks 6351, 6361 located at one of the two open ends of the brace, and sliding cradle 6352, 6362 located at the other open end of the brace. doing. Since the sliding rack 6351 is inserted into the sliding cradle 6362 of the sliding brace 6360, and the sliding rack 6361 is inserted into the sliding cradle 6352 of the sliding brace 6350, the two sliding braces are put together into the sliding closing plate 6300. Become.

The sliding closure plate 6300 further includes an anchor 200. The anchor can be used as described above to support the closure element. The closure element may be a band, an integral V-shaped element, or other similar element described herein. Although the closure plate has some freedom of movement in the direction of the sliding racks 6351, 6361, the large hole closure plate assembly 5000 is retained by the application of force to the anchor 200, thereby joining tissue. To close the large hole opening.

Another preferred embodiment of a large hole closure plate assembly with some freedom of movement of the closure plate is shown in Figures 32A-32B. The large hole closure plate assembly 7000 includes a rectangular sliding closure plate 7300 formed from two sliding braces 7350 and 7360. The sliding braces 7350, 7360 have sliding tubes 7351, 7361 located at one end of the brace and sliding cavities 7352, 7362 located at the other open end of the brace. Since the sliding tube 7351 is inserted into the sliding cavity 7362 of the sliding brace 7360, and the sliding tube 7361 is inserted into the sliding cavity 7352 of the sliding brace 7350, the two sliding braces are put together into the sliding closing plate 7300. Become.

The sliding closure plate 7300 further includes an anchor 200. The anchor can be used as described above to support the closure element (not shown). The closure element may be a band, an integral V-shaped element, or other similar element described herein. Although the closure plate has some freedom of movement in the direction of the sliding tubes 7351, 7361, the large hole closure plate assembly 7000 is retained by the application of force to the anchor 200, thereby joining tissue. To close the large hole opening.

Tissue closure may be accomplished percutaneously using a percutaneous tissue closure device. Such a device, in contrast to the various embodiments shown herein that exert a force on the outer surface of the tissue, causes the tissue to be opened by the application of force, thereby opening the tissue from the interior of the tissue to the opening of the tissue. You can approach.

In a preferred embodiment, a percutaneous tissue closure device 8005 is provided for inserting a closure element below the surface of the tissue and pulling from within the tissue until the opening of the tissue is closed. As shown in FIG. 33, the percutaneous tissue closure device 8005 includes a working tube 8100 having a distal end about which a pusher pin and a closure element are wrapped around in a pre-applied state. Closure element 8300 is shown in FIG. 33 wrapped around the distal end of working tube 8100 and attached to anchor 3200 (described above). The pusher pin 8600 is wrapped around the working tube 8100 in a state before application. Each pusher pin 8600 may include a pusher collar 8610. In the pre-applied state, the closure element 8300 is wrapped around the working tube 8100 along each pusher pin 8600 so that the pusher collar 8610 is positioned just below the coupling element 3210 of the anchor 3200 and around the closure element 8300. Fits. In another preferred embodiment, pusher pin 8600 does not include pusher collar 8610.

The outer sheath 8800 shown in FIG. 34A can be introduced over the working tube 8100 and the wrapped closure element 8300 and pusher pin 8600. As shown in FIGS. 34B and 34C, the outer sheath 8800 can be removed by sliding it proximally, exposing the working tube 8100 and the wrapped closure element 8300 and pusher pin 8600. As also shown in FIGS. 34A-34C, a dilator 8700 is used to expand an opening in tissue for application of the closure element 8300.

Exposed closure element 8300 and anchor 3200 are shown at an angle that is neither parallel nor perpendicular to the axis of working tube 8100 and outer sheath 8800, but not parallel to the axis of working tube 8100 and outer sheath 8800. , The closure element 8300 and the anchor 3200 may be arranged in an angular range including a vertical angle.

The use of percutaneous tissue closure device 8005 is described below with reference to Figures 35A-35H. FIG. 35A shows tissue 8900 being penetrated by guide wire 8710. Guidewire 8710 is attached to device 8005 via dilator 8700. In this figure, outer sheath 8800 covers working tube 8100 and wrapped closure element 8300 and pusher pin 8600.

FIG. 35B shows a device in which a dilator 8700 has been pushed through tissue 8900 such that the distal end of working tube 8100 (not shown) underneath outer sheath 8800 is below the surface of tissue 8900. 8005 is shown. In FIG. 35C, the outer sheath 8800 has been moved proximally, exposing the wrapped closure element 8300 and pusher pin 8600. Although only two closure elements 8300 are shown for simplicity, any number of closure elements 8300 may be used. FIG. 35D is a close-up view showing the closure element 8300 and anchor 3200 in a still wrapped (ie, prior to application) state, with the outer sheath 8800 removed to expose the closure element to tissue.

FIG. 35E shows the extension of the closure element. The extension of the closure element may be done manually and the operator may apply an extension force by turning a knob located at the proximal end of the device 8005, or alternatively fluid flow, air pressure, hydraulic pressure, or The extension force can be applied by any other external force. As the closure element 8300 extends, the anchor 3200 is pushed into the tissue 8900 through the surface 8910 of the expanded opening in the tissue. Once extended, anchor 3200 generally enters tissue 8900 and closure element 8300 reaches full extension length, as shown in FIG. 35F. Closure element 8300 may be formed from any suitable shape memory alloy, such as Nitinol, spring loaded steel, or other alloys or materials with suitable properties, whereby elongated closure element 8300 may be extended from anchor 3200. A force is applied proximally as viewed, pulling the anchor 3200 in a direction opposite to the insertion direction. Wings 3207 resist this proximal movement, hold anchor 3200 in place, and exert a closing force on tissue 8900, as described above.

35G and 35H, percutaneous tissue closure device 8005 has been removed from tissue 8900, leaving closure element 8300. The closing force applied by the closure element 8300 on the tissue 8900 keeps the tissue opening closed. Such closure of tissue is maintained upon hemostasis. Moreover, since the device operates percutaneously, all of the closure force acts in a direction parallel to the closure element 8300, helping to maintain proper hemostatic balance. Furthermore, less material is left in the tissue and no material is left on the surface of the tissue. At the surface of the tissue, the material may interact with other body parts.

In the preferred embodiment shown in FIGS. 36A and 36B, the percutaneous tissue closure device 8005 includes a knob 8035 for driving the anchor 3200 to initiate a mechanical movement to push it into the tissue. In FIG. 36A, closure element 8300 is wrapped around working tube 8100. In FIG. 36B, sleeve 8350 is used to drive anchor 3200 attached to closure element 8300 and force it percutaneously into tissue following rotation of knob 8035.

In a preferred embodiment, working tube 8100 may include cam 8150. The mechanical action initiated by pivoting knob 8035 can then pivot cam 8150 shown in FIGS. 37A and 37B. As shown in FIG. 37B, as cam 8150 is pivoted, sleeve 8350 extends from a wrap position around cam 8150 to an extended position. The sleeve 8350 rests on the coupling element 3210 of the anchor 3200 so that the anchor 3200 is driven radially outward from the cam 8150 as the sleeve 8350 extends. The preferred embodiment is shown in proximal view in FIGS. 38A and 38B.

FIG. 39 shows the cam 8150 and one closure element 8300 separated and with the anchor 3200 and the elongated sleeve 8350.

FIG. 40 shows a sleeve 8350 in an expanded configuration that includes fingers 8351 used to couple with anchor 3200.

In a preferred embodiment, as shown in FIGS. 41A and 41B, the anchor 3200 can be pushed into tissue by driving it using a working tube 8160 that includes a press 8161 and a trough 8162. As shown, the press 8161 can drive the closure device 8300 and the anchor 3200 in the distal direction to drive it into the tissue.

The closure elements 300, 1300, 2300, 3300, 4300, 5300, 6300, 7300, 8300 disclosed herein may be an elastomer, such as silicone. However, it goes without saying that the closure elements 300, 1300, 2300, 3300, 4300, 5300, 6300, 7300, 8300 may be formed of any suitable material, for example a bioabsorbable material. Further, if the anchors 200, 1200, 3200 are also formed from bioabsorbable material, the anchors 200, 1200, and/or 3200, and the closure elements 300, 1300, 2300, 3300, 4300, 5300, 6300, 7300, and A self-acting closure assembly including/or 8300 (typically left in the patient's body after completion of the procedure) can be absorbed into the patient's body. Although a plurality of elastomeric closure elements 300, 1300, 2300, 3300 are described in the context of the preferred embodiment, it should be understood that a single continuous closure element may be provided (eg various anchors 200, 1200, a single integral member extending between 3200). Furthermore, instead of or in addition to one or more elastomeric closure elements, any other propulsion mechanism, for example a spring, may be provided as closure element. Moreover, it goes without saying that the anchors 200, 1200, 3200 and the closure elements 300, 1300, 2300, 3300, 4300, 5300, 6300, 7300, 8300 are oriented with reference patterns that are preferred herein described. It may differ from the embodiment.

In the preferred embodiment of the present invention, the anchor 4200 shown in FIG. 42 will be described. Anchor 4200 includes a distal tip 4230 and a stem 4201 extending proximally from the base of distal tip 4230. The stem 4201 is joined at the shoulder 4240 to the base of the distal tip 4230. Wings or hooks 4207, 4208 extend proximally and, to some extent, radially from the base of the distal tip 4230, and join at the shoulder 4240 to the base of the distal tip 4230. The barbs 4207, 4208 extend proximally and radially radially from the distal tip 4230 to a free end. Figure The free end may flare further radially outward, as shown in FIG. Unlike the wings or hooks 207, 208 described above, the wings or hooks 4207, 4208 are not formed from cuts or splits made in the body of the anchor, so the thickness of the stem 4201 is It is not affected by the inclusion of the hooks 4207, 4208. The wings or hooks 4207, 4208 may have the relaxed, uncompressed position shown in FIG. In the uncompressed position, the barbs 4207, 4208 are not biased and have a barb opening W. The hook-shaped portions 4207 and 4208 can be closer to the stem 4201 by being compressed. Various amounts of compression can be applied to the barb, such that the greater the compression, the closer the barb is to the stem. The barbs 4207, 4208 can include protrusions at the free ends of the barbs that allow them to engage tissue once the anchor is deployed. Although two barbs 4207, 4208 are shown, it should be understood that any number of barbs may be provided. Similarly, the free end of the barb may be provided with any number of protrusions, including one sharp protrusion.

The stem 4201 can be flexible and can bend or flex with respect to the barbs 4207, 4208 and the distal tip 4230. Once deployed in tissue, the flexible stem provides a different force profile on the anchor 4200 as compared to an anchor having a rigid or unbendable stem. A flexible shaft that can flex against the barb and distal tip forms a living hinge between these elements of the anchor. The force acting on the anchor from its proximal end (the closure element coupled to the proximal end of the anchor) can be at least partially absorbed by the flexible stem, so that the wings or hooks of the anchor are The effect of these forces applied to can be reduced. In a given tissue environment, the flexible shaft may increase the likelihood of blocking leverage by the anchor, and thereby prevent the anchor from being partially or completely withdrawn from the tissue. The stem 4201 may include an eyelet 4210 at its proximal end. The eyelet can be configured to receive the suture 4400. In a preferred embodiment, the flexibility of stem 4201 allows the use of suture 4400 as opposed to an elastomeric closure element. In combination, by applying a closing force to the flexible stem 4201 through the suture 4400 in the proximal eyelet 4210, to close the wound as compared to the force required to pull the anchor 4200 out of the tissue. The power becomes smaller. In this way, the wound can be closed more completely.

It may be advantageous to reduce the size of anchor 4200. For example, reducing the thickness of tip 4230, barbs 4207, 4208, and stem 4201 allows more anchors to be deployed in a smaller space in tissue, allowing a circular deployment configuration. Referring to FIG. 43, deploying the anchor in a more circular configuration creates a more uniform force distribution around the wound. In combination with the flexible stem 4201 and proximal eyelet 4210, the uniform force distribution further prevents the anchor 4200 from being pulled out of the tissue and more completely closes the wound.

As another example, reducing the mass of anchor 4200 helps increase the rate of drive of anchor 4200 to force it into tissue. In the case of remote fixation, the tissue receiving the anchor is not retained or fixed during deployment of the anchor. As mentioned above, rapid penetration may be necessary to accurately penetrate soft tissue that is not retained or fixed. By reducing the mass of the anchor 4200, the achieved drive speed is increased. In the preferred embodiment, the velocity of the driven anchor can be expressed based on the following equation: m is the mass of the anchor, k _spring is the spring constant of the drive spring, F _friction is the coefficient of friction between the anchor and the distal end of the driver, and l ₂ -l ₁ is the difference in spring length. Show.

In another embodiment, the velocity of the driven anchor can be expressed according to the following equation: l is the spring length and l ₀ −l is the difference in spring length.

In addition to the drive speed of the anchor 4200, the shape of the anchor 4200 shown in FIG. 42 allows the drive of the anchor to be controlled so that the anchor is driven to a suitable depth within the tissue. The shape of the anchor 4200 is the shape of the distal tip 4230, the shape of the hooks 4207, 4208, the folds 4203 along the radially outer length of the hooks 4207, 4208, or the proximal of the hooks 4207, 4208. Includes side and radial free end protrusions 4204, radially inner concave surfaces of hooks 4207, 4208, length of anchor 4200, including length of stem 4201, and shape of eyelet 4210. As the anchor 4200 is driven and pushed into the tissue, it experiences the force exerted by the tissue. The combination of drive speed and anchor geometry prevents the anchor from being driven beyond the required depth. Anchor 4200 deployed into tissue is shown in FIG.

As described above, the proximal eyelet 4210 may be configured to receive the suture 4400. In contrast to the elastomeric closure element, once the anchor 4200 is driven and pushed into the tissue with the suture 4400 being hand pulled through the eyelet 4210, tensioning is required to close the wound. There are cases. In a preferred embodiment of the invention, the tensioner 4410 can be used to tension the suture 4400. As shown in FIG. 43, the anchors 4200 can be deployed in a circular configuration and the sutures 4400 follow a circular pattern through their respective proximal eyelets 4210. The first end of suture 4400 may be tied to form knot 4420. Suture 4400 then extends through the circular pattern of eyelets, through knot 4420, and proximally to tensioner 4410 away from the wound closure. As an alternative to knot 4420, the structure is secured to the first end of suture 4400, or near the first end of suture 4400, and suture 4400 slides through the structure. Other structures may be provided in accordance with the present invention as long as they enable

As shown in FIG. 45A, the tensioner 4410 may be a hollow tubular member having a narrowed distal tip 4411 and a hollow axially inner core 4412. Suture 4400 extends through tensioner 4410 through hollow core 4412 to allow a surgeon or other operator to pull or pull suture 4400 proximally. In one preferred embodiment, the suture 4400 extends beyond the proximal end of the tensioner 4410 so that the operator can directly engage the suture. In another preferred embodiment, the tensioner 4410 can include a proximal end 4413 that can be removed from the body of the tensioner 4410. The suture 4400 can be coupled to the proximal end 4413 of the tensioner 4410 so that once the proximal end 4413 is removed from the tensioner 4410, the operator can use the proximal end 4413 as a suture grip. , Suture 4400 can be pulled or pulled. The tensioner 4410 may include scoring, cuts, breaks, grooves, or the like to allow an operator to snap the proximal end suture grip 4413 off the tensioner 4410. In another preferred embodiment, the suture grip 4413 may not be attached to the tensioner 4410.

As the suture 4400 is pulled proximally through the tensioner 4410, the tensioner 4410 approaches the knot 4420 distally. The relative size of the knot 4420 and the diameter of the hollow axially inner core 4412 are such that the knot 4420 is larger than the distal opening of the hollow axially inner core 4412 and does not fit into this opening. There must be. As shown in FIG. 45B, pulling suture 4400 proximally through tensioner 4410 causes suture 4400 to be cinched in a cinching motion around the circular configuration of anchor 4200, closing the wound. Thus, suture 440 and tensioner 4410 may be used by a surgeon or operator to control the tension applied to suture 4400 and anchor 4200 configurations.

Any of the delivery devices described herein, including delivery devices 5, 1005 and 8005, may be configured to drive anchor 4200. Specifically, anchor 4200 can be driven by applying a driving force to shoulder 4240 of anchor 4200 to drive anchor 4200 distally. The delivery devices 5, 1005 and 8005 can include fingers 3610 that contact the anchors 4200 at the shoulders 4240 so that the wings or hooks 4207, 4208 extend beyond the contact points between the fingers 3610 and the anchors 4200. Extends proximally. Similarly, stem 4201 can extend proximally beyond the point of contact between finger 3610 and anchor 4200.

Delivery device 4005 may include the features described above with respect to devices 5, 1005, and 8005. Delivery device 4005 includes a distal end 4025 shown in Figures 47A-48D. In one preferred embodiment, the delivery device 4005 can be applied endoscopically so that the end 4025 allows the surgeon or operator to view the distal end through the monitoring system. In addition, it may be radiopaque.

46A-D are cross-sectional views showing deployment of anchor 4200 from distal end 4025. 47A-47D show the same deployment as seen from outside the distal end 4025. Distal end 4025 may include window 4026. The window 4026 may be formed similarly to the notch or slot 26 described above. The window 4026 differs from the slot 26 in that the opening of the window 4026 ends in the constriction element 4027 rather than extending to the distal end of the distal end 4025. Prior to deployment, anchor 4200 is located within delivery device 4005 and anchor 4200 may be oriented such that barbs 4207, 4208 extend into window 4026. The window 4026 thus allows the anchor 4200 to be located within the delivery device 4005, while allowing the barbs 4207, 4208 to occupy a relaxed, uncompressed position. As such, the delivery device 4005 can be stored or transported with the anchor 4200 located within the delivery device, in which case structural features of the barb, such as response to compressive forces, are affected. No concern.

Stenosis element 4027 is located between window 4026 and the ultimate distal end of distal end 4025. As shown in FIG. 46B, when the deployment of anchor 4200 is initiated and fingers 3610 begin driving anchor 4200 through distal end 4025, barbs 4207, 4208 contact constriction element 4027. As the anchor 4200 is propelled past the constriction element 4027, the constriction element 4027 exerts a compressive force on the barbs 4207, 4208, compressing the barbs and approaching the stem 4201. As shown in FIG. 46C, as the driver continues to drive anchor 4200 and pushes it through tissue from distal end 4026, barbs 4207, 4208 cause distal end 4026 to include stenotic element 4027. Over. Beyond distal end 4026 and constriction element 4027, barbs 4207, 4208 expand toward a relaxed, uncompressed position. In practice, the surgeon or operator presses distal end 4026 against the tissue at the deployment site. Thus, beyond the distal end 4026, the anchor 4200 is pushed into the tissue. As the barbs 4207, 4208 cross the constriction element 4027 and into the tissue, the barbs do not fully expand to the relaxed, uncompressed position, and thus have a compressed profile, which results in an anchor. The 4200 is more easily pushed into the tissue. As anchor 4200 continues to enter tissue, barbs 4207, 4208 expand toward an uncompressed position. This expansion of the barb from the compressed position to the uncompressed position slows down the anchor as it is pushed into the tissue and is responsible for limiting the depth at which the anchor is pushed into the tissue. To do.

As mentioned above, the shape of the anchor 4200, including the profile of the barbs 4207, 4208 as the anchor enters tissue, as well as the drive speed of the anchor 4200, contributes to the exact depth to which the anchor 4200 is driven. Adjusting the shape of the anchor, including compressing the barbs just prior to entering the tissue, allows the surgeon or operator to determine the exact depth for deployment of the anchor.

In the preferred embodiment of the invention, device 4005 comprises a proximal portion and a distal portion. The proximal and distal portions may be separable and may be coupled to enclose a dynamically stored force, such as a spring. The spring may be compressed between the proximal and distal portions, and this compression may be retained by a latching mechanism that has a trigger element. In the distal direction, the spring may be in contact with a drive element of the device 4005, such as a hammer sleeve or an extension arm or finger, as described above with reference to Figures 5C-6C. When the trigger device is actuated by the operator, the latching mechanism releases the compressed spring. The compression spring expands quickly and transfers its kinetic energy to the anchor to drive it.

Although the above use of the exemplary device 5 includes driving the anchors 200, 1200, 3200, 4200 prior to forming the surgical access opening, it goes without saying that the anchors 200, 1200, 3200 after forming the opening. 4200 may be driven. Similarly, anchors 200, 1200, 3200, 4200 may be ejected from device 1005 prior to expanding the hole. However, driving the anchor after forming the opening or expanding the hole is less advantageous. Because the formation of the opening in the former procedure and the expansion in the latter procedure pushes the tissue away from the hole, so that the subsequently driven anchor is located closer to the opening when the tissue is in the relaxed state. become. Therefore, the amount of tissue between the anchors 200, 1200, 3200, 4200 is low, possibly resulting in less compressive force being applied to the tissue as compared to anchors driven prior to forming the surgical access opening.

Furthermore, it should be understood that the closure device 5, 1005, 8005 may be provided in connection with any suitable surgical device, such as a catheter, or a flexible thoracoscopic shaft. Further, any suitable drive mechanism for driving the anchors 200, 1200, 3200, 4200 may be provided.

Although the closure elements 300, 1300, 2300, 3300, 4400, 5300, 6300, 7300, 8300 are formed as a single, unitary member, it goes without saying that any closure element described herein It may consist of several components.

Further, although the examples described herein are described as firing multiple anchors 200, 1200, 3200, 4200, each identical to one another, it goes without saying that the driven anchor set is It may include one or more anchors that are different than the other anchors. For example, the situation of non-uniform tissue properties and dimensions can be addressed, for example, by simultaneously firing different types of anchors at different locations. In this regard, devices 5, 1005, 8005 are configured to receive different types of anchors in different slots and/or have interchangeable housing portions for receiving various anchors. Good.

Further, anchors 200, 1200, 3200, 4200 are US provisional patent application No. 61/296,868, filed January 20, 2010, and US, filed January 20, 2011. It may include any of the features of fasteners or other similar implants disclosed in patent application Ser. No. 13/010,766, and using any of the mechanisms disclosed herein. It may be driven.

Further, implantable elements described herein, such as anchors 200, 1200, 3200, 4200, and/or closure elements 300, 1300, 2300, 3300, 4400, 5300, 6300, 7300, 8300 are, for example, Depending on the particular application, it may be formed wholly or partly from a material that can be absorbed into the patient's body or from a non-absorbable material. For example, these elements may be formed from polyglycolic acid (PGA), or PGA copolymer. These elements may additionally or alternatively be formed from copolymers of polyester and/or nylon and/or other polymers. In addition, these elements may contain one or more shape memory alloys, such as Nitinol, spring loaded steel, or other alloys or materials with suitable properties.

Resorbable materials are advantageous where there is the potential for misfire or improper placement of various implants. For example, in situations where a driver drives anchors 200, 1200, 3200, 4200 at unintended locations, or where tissue does not properly accept anchors 200, 1200, 3200, 4200, anchors 200, 1200, 3200, 4200 may: Even if it is not needed, it is relatively harmless as it is eventually absorbed by the patient.

Although exemplary surgical applications have been described above, devices 5, 1005, 8005 are in no way limited to these examples.

Although the present invention has been described with reference to specific examples and preferred embodiments, it goes without saying that the above description is in no way limiting. Furthermore, the features described herein can be used in any combination.
[Configuration 1]
A distal end tapered towards a distal tip formed to pierce tissue,
A flexible stem extending proximally from the distal end,
At least one hook extending from the distal end proximally and radially outwardly to a free end including a radially outer surface and a radially inner surface;
Equipped with
The radially outer surface includes a longitudinally extending fold, the fold providing proximally extending projections at the free end;
The flexible stem is flexible with respect to the at least one barb and distal tip,
Surgical anchor.
[Configuration 2]
The anchor of configuration 1, wherein a force is exerted on the anchor by at least one of (a) tissue, (b) fluid flow, (c) air pressure, (d) hydraulic pressure, and (e) external force.
[Configuration 3]
The anchor according to configuration 1, wherein the radially inner surface is concave.
[Configuration 4]
The anchor of configuration 1, wherein the flexible stem is configured to flex in cooperation with a force applied to the anchor.
[Configuration 5]
The anchor of claim 1, wherein the barb is configured to resist proximal movement of the anchor after the anchor is driven into the tissue.
[Configuration 6]
An anchor according to configuration 1, wherein the barb extends to a free end and includes a plurality of proximally extending cutting protrusions at the free end.
[Configuration 7]
The anchor of configuration 1, wherein the barb extends to a free end, and the folds provide a plurality of proximally extending cutting prongs to the free end of the barb.
[Configuration 8]
An anchor according to configuration 1, wherein the anchors are arranged in a configuration having a plurality of anchors along a ring-shaped circumference.
[Configuration 9]
An anchor according to configuration 1, wherein the anchors are arranged in a square shape and in a form having a plurality of anchors.
[Configuration 10]
The anchor of configuration 1, wherein the anchor is formed of a bioabsorbable material.
[Configuration 11]
The anchor of configuration 1, wherein the flexible stem further comprises a proximal eyelet configured to receive a closure element.
[Configuration 12]
The anchor according to configuration 11, wherein the closure element is a suture.
[Configuration 13]
An anchor, the anchor comprising a distal end tapered toward a distal tip formed to pierce tissue, and a distal end proximally and radially outwardly from the distal end. The anchor shoulder having at least one barb extending from the distal end and a flexible stem extending proximally from the distal end, wherein the shoulder is flexible. An anchor that is arranged at the intersection of the stem and the distal portion of the hook-shaped portion, or is arranged more distally than the intersection, and
A driver configured to apply a driving force to the shoulder of the anchor to drive the anchor into the tissue.
Is equipped with
The hook-shaped portion includes a radially outer surface and a radially inner surface, the radially outer surface includes a fold extending in the longitudinal direction, and the fold has a plurality of protrusions extending proximally to the free end. To provide,
Surgical device.
[Configuration 14]
The surgical apparatus of configuration 13, wherein the anchors are arranged in a configuration having a plurality of anchors, and further, the driver is configured to drive the anchors simultaneously.
[Configuration 15]
15. The surgical device of configuration 14, wherein the driver is configured to drive the anchor a predetermined distance.
[Configuration 16]
15. The surgical apparatus of configuration 14, wherein the driver comprises a spring loaded element configured to impact the anchor and impart distally directed momentum to the anchor.
[Configuration 17]
The surgical device of configuration 13, wherein the barb extends proximally beyond the shoulder.
[Configuration 18]
14. The surgical device of configuration 13, wherein the driver includes a pin in contact with the shoulder of the anchor, the pin configured to drive the anchor distally and force it into tissue.
[Configuration 19]
A surgical device,
A distal end tapered towards a distal tip configured to pierce tissue, and at least one barb extending proximally and radially outwardly from the distal end to a free end. A surgical anchor including
A distal end including at least one window formed to allow the barb to expand to a relaxed position and at least one constriction element formed to compress the barb to a compressed position. A delivery mechanism having a proximal end,
Is equipped with
The hook-shaped portion includes a radially outer surface and a radially inner surface, the radially outer surface includes a fold extending in the longitudinal direction, and the fold has a plurality of protrusions extending proximally to the free end. Provided to
The barb is positioned within the window such that the barb is in a relaxed position before the delivery mechanism ejects the anchor;
The barb faces the constriction element so as to constrict from the relaxed position to the compressed position while the delivery mechanism ejects the anchor; and
The barb is configured to return to the relaxed position once ejected from the delivery mechanism,
Surgical device.
[Configuration 20]
A surgical device,
A distal end tapered towards a distal tip configured to pierce tissue, and at least one barb extending proximally and radially outwardly from the distal end to a free end. A surgical anchor including a flexible stem extending proximally from the distal end and a proximal eyelet;
A closure element configured to be received by the proximal eyelet,
A tensioner comprising a hollow axial core formed to receive the closure element and to allow the closure element to slide through the tensioner;
A surgical device.
[Configuration 21]
21. The surgical device according to configuration 20, wherein the closure element is a suture.

Claims (18)

A surgical anchor,
A distal end tapered towards a distal tip formed to pierce tissue,
A flexible stem extending proximally from the distal end,
At least one hook extending from the distal end proximally and radially outwardly to a free end including a radially outer surface and a radially inner surface, the radially outer surface And at least one hook, the radially inner surface of which includes a longitudinally extending fold, the fold providing a plurality of proximally extending ridges at the free end,
Equipped with
The at least one barb is compressible such that the free end is juxtaposed with the flexible stem at a location on the flexible stem proximal to the distal end. And the thickness of the flexible stem is the portion of the flexible stem from the distal end to the location on the flexible stem proximal to the distal end. Is constant at
The flexible stem is flexible with respect to the at least one barb and distal tip, and the force exerted on the proximal end of the anchor is at least partially due to the flexible stem. Absorbed,
Surgical anchor. The anchor of claim 1, wherein a force is applied to the anchor by at least one of (a) tissue, (b) fluid flow, (c) air pressure, (d) hydraulic pressure, and (e) external force. The anchor according to claim 1, wherein the radially inner surface is concave. The anchor of claim 1, wherein the flexible stem is configured to flex in cooperation with a force applied to the anchor. The anchor of claim 1, wherein the barb is formed to resist proximal movement of the anchor after the anchor has been driven into the tissue. The anchor of claim 1, wherein the barb extends to a free end and includes a plurality of proximally extending cutting protrusions at the free end. The anchor of claim 1, wherein the barb extends to a free end and the pleats provide a plurality of proximally extending cutting prongs to the free end of the barb. An anchor according to claim 1, wherein the anchors are arranged in a configuration having a plurality of anchors along a ring-shaped circumference. An anchor according to claim 1, wherein the anchors are arranged in the form of a square and having a plurality of anchors. The anchor of claim 1, wherein the anchor is formed of a bioabsorbable material. The anchor of claim 1, wherein the flexible stem further comprises a proximal eyelet configured to receive a closure element. The anchor of claim 11, wherein the closure element is a suture. An anchor, the anchor comprising a distal end tapered toward a distal tip formed to pierce tissue, and a distal end proximally and radially outwardly from the distal end. The anchor shoulder having at least one barb extending from the distal end and a flexible stem extending proximally from the distal end, wherein the shoulder is flexible. An anchor that is arranged at the intersection of the stem and the distal portion of the hook-shaped portion, or is arranged more distally than the intersection, and
A driver configured to apply a driving force to the shoulder of the anchor to drive the anchor into the tissue.
Is equipped with
The hook-shaped portion includes a radially outer surface and a radially inner surface, the radially outer surface includes a fold extending in the longitudinal direction, and the fold has a plurality of protrusions extending proximally to the free end. Provided to
The barb is compressible such that the free end is in parallel with the flexible stem at a location on the flexible stem proximal to the distal end, The thickness of the flexible stem is constant at the portion of the flexible stem from the distal end to the location on the flexible stem proximal to the distal end. Yes,
The force acting on the proximal end of the anchor is at least partially absorbed by the flexible stem,
Surgical device. The surgical apparatus of claim 13, wherein the anchors are arranged in a configuration having a plurality of anchors, and further, the driver is configured to drive the anchors simultaneously. The surgical device of claim 14, wherein the driver is configured to drive the anchor a predetermined distance. 15. The surgical device of claim 14, wherein the driver comprises a spring loaded element configured to impact the anchor to impart distally directed momentum to the anchor. 14. The surgical device of claim 13, wherein the barb extends proximally beyond the shoulder. 14. The surgical device of claim 13, wherein the driver includes a pin in contact with the shoulder of the anchor, the pin configured to drive the anchor distally and force it into tissue.

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