US20220104810A1 - Suture needle packages for loading suture needles and methods of passing suture needles through trocars - Google Patents
Suture needle packages for loading suture needles and methods of passing suture needles through trocars Download PDFInfo
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- US20220104810A1 US20220104810A1 US17/545,170 US202117545170A US2022104810A1 US 20220104810 A1 US20220104810 A1 US 20220104810A1 US 202117545170 A US202117545170 A US 202117545170A US 2022104810 A1 US2022104810 A1 US 2022104810A1
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- needle
- suture needle
- suture
- tip
- needle driver
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Images
Classifications
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- A61B17/00—Surgical instruments, devices or methods, e.g. tourniquets
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- A61B17/06—Needles ; Sutures; Needle-suture combinations; Holders or packages for needles or suture materials
- A61B17/06114—Packages or dispensers for needles or sutures
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Definitions
- the present patent application is generally related to surgical procedures and surgical tools, and is more specifically related to systems, devices and methods for loading suture needles and passing suture needles through trocars.
- trocars to position surgical tools, such as suture needles, at surgical sites.
- the size of a suture needle (e.g., a needle attached to a suture) or a surgical needle (e.g., a needle not attached to a suture) that can be passed through the trocar to a surgical site is limited by the size of the opening in the trocar.
- surgeons desire to use larger needles for closing surgical wounds and repairing anatomical features, however, passing larger needles through smaller trocars is difficult.
- 5 mm trocars are often used during minimally invasive surgeries (MIS), however, surgeons cannot pass the larger suture needles through the 5 mm trocars so they are forced to use only smaller suture needles.
- MIS minimally invasive surgeries
- the smaller suture needles are less than optimal because, inter alia, they often require a surgeon to make many more passes of the needle and suture through tissue, which lengthens the surgical procedure and can frustrate the surgeon. Using smaller needles may also produce a bite distance that puts the wound or anatomical feature at risk of dehiscence.
- surgical needle and suture needle are used interchangeably.
- a surgical needle may have a suture attached thereto or may not have a suture attached thereto.
- a suture needle may have a suture attached thereto or may not have a suture attached thereto. Regardless of whether the terms surgical needle or suture needle are used herein, the terms may be used to describe both needles having sutures attached thereto and needles that do not have sutures attached thereto.
- a surgical needle or suture needle is preferably made of a hyper-elastic and/or or superelastic material, such as Nitinol.
- the suture needle may be elastically deformed to lower the height and/or the profile of the suture needle to pass the suture needle through a trocar, such as a trocar having a diameter of 5 mm or smaller.
- a needle driver may be used to secure a tapered section at a distal end of the suture needle with the barrel of the suture needle trailing behind the tip of the suture needle.
- the tip is preferably surrounded by clamping jaws at the distal end of the needle driver for protecting the tip as the suture needle is passed through a trocar.
- the clamping jaws preferably surround and protect the tip for preventing the tip from contacting the inside of the trocar as it is passed through the trocar, which could damage the tip during its passage through the channel of the trocar.
- the tip of the needle when the suture needle is held by the needle driver, the tip of the needle does not extend or protrude outside the external surface of the needle holder.
- a suture needle package preferably includes a base, and a needle driver alignment guide overlying the base, the needle driver alignment guide including first and second lateral guide walls that oppose one another for defining a needle driver guide channel.
- a suture needle desirably overlies the base.
- the suture needle may include a proximal end and a distal end having a tapered section that terminates at a tip.
- at least one connector releasably secures the suture needle over the base.
- the at least one connector desirably orients the suture needle relative to the first and second lateral guide walls so that the tip of the suture needle is located within the suture needle guide channel and is bounded by the first and second lateral guide walls.
- the needle driver guide channel preferably has a proximal end, a distal end, and a longitudinal axis that extends between the proximal and distal ends thereof.
- the needle driver alignment guide may include an end wall interconnecting the first and second lateral guide walls for defining the distal end of the needle driver guide channel.
- the end wall desirably interconnects distal ends of the first and second lateral guide walls.
- the first and second lateral guide walls are desirably parallel to one another.
- the end wall and the distal ends of the first and second lateral side walls preferably surround the tip of the suture needle.
- each of the first and second lateral guide walls has a lower end and an upper free end, and the at least one connector holds the tip of the suture needle between the lower ends and the upper free ends of the respective first and second lateral guide walls.
- the at least one connector preferably secures the tip of the suture needle closer to the distal end of the needle driver guide channel and secures the proximal end of the suture needle closer to the proximal end of the needle driver guide channel.
- the at least one connector may include a securing notch formed in the upper free end of one of the first and second lateral guide walls.
- the tapered section of the suture needle is seated in the securing notch and the tapered section extends proximally from the tip of the suture needle.
- the tapered section of the suture needle preferably extends along an axis that defines an angle with the longitudinal axis of the needle driver alignment channel of less than 90 degrees, which preferably enables the suture needle to be passed through a trocar using less force.
- the at least one connector may include a second connector that is located proximal to the securing notch for securing a section of the suture needle that is proximal to the tapered section of the suture needle.
- the suture needle may be made of an elastic, hyper-elastic, or superelastic material or alloy such as Nitinol.
- a system for aligning a needle driver with a tip of a suture needle may include a suture needle package having a base, a needle driver alignment guide overlying the base, and at least one connector for releasably securing the suture needle to the suture needle package.
- the needle driver alignment guide preferably includes first and second lateral guide walls that oppose one another for defining a needle driver guide channel.
- an end wall desirably interconnects the first and second lateral guide walls for defining a distal end of the needle driver alignment guide.
- a suture needle desirably overlies the base.
- the suture needle may include a proximal end and a distal end having a tapered section that terminates at a tip.
- the at least one connector preferably secures the suture needle over the base and controls the orientation of the suture needle so that the tip of the suture needle is located within the suture needle guide channel and is bounded by the end wall and the first and second lateral guide walls.
- a needle driver may have an elongated shaft and a clamping assembly located at a distal end of the elongated shaft.
- the clamping assembly engages the end wall of the needle driver alignment guide for aligning the clamping assembly with the tip of the suture needle.
- the at least one connector desirably holds the tip of the suture needle between the first and second lateral guide walls so that the tip is spaced away from the first and second lateral guide walls.
- the at least one connector may hold the tip of the suture needle proximal to and spaced away from the end wall of the needle driver alignment guide by a first distance.
- a clamping assembly preferably has a lower jaw with a top surface and an opposing upper jaw with a bottom surface that is pivotally coupled with the lower jaw for moving the clamping assembly between open and closed positions.
- a distal end of the lower jaw engages the end wall, whereupon the top surface of the lower jaw is aligned with the tip of the suture needle.
- the top surface of the lower jaw preferably has a length that extends between a proximal end and the distal end thereof. In one embodiment, the length of the top surface of the lower jaw is desirably greater than the first distance between the tip of the suture needle, secured by a connector, and the end wall of the needle driver alignment guide.
- the upper jaw of the clamping assembly when the clamping assembly is abutted against the end wall of the alignment guide, the upper jaw of the clamping assembly is desirably positioned over the tip of the suture needle and the lower jaw of the clamping assembly is desirably positioned under the tip of the suture needle.
- first and second lateral guide walls are spaced from one another to define a width of the needle driver alignment guide.
- a resilient element such as a foam pad or one or more springs, may be disposed between the first and second lateral guide walls for urging a needle driver against one of the first and second lateral guide walls.
- the elongated shaft of the needle driver has a width that is substantially equal to the width of the needle driver alignment guide.
- the elongated shaft of the needle driver has an outer diameter
- the needle driver alignment guide preferably has a depth that is about 1 ⁇ 2 the dimension of the outer diameter of the elongated shaft of the needle driver.
- a method of delivering a suture needle to a surgical site desirably includes obtaining a suture needle package having a needle driver alignment channel, and a suture needle secured to the suture needle package, the suture needle having a distal end with a tapered section that terminates at a tip, whereby the tapered section and the tip of the suture needle are positioned within the needle driver alignment channel.
- a method includes positioning a needle driver in the needle driver alignment channel, the needle driver having a clamping assembly at a distal end thereof that is moveable between open and closed positions.
- the clamping assembly is preferably advanced along a longitudinal axis of the needle driver alignment channel toward a distal end of the needle driver alignment channel for aligning the clamping assembly with the tip of the suture needle.
- the clamping assembly may be moved to the closed position for clamping the portion of the tapered section of the suture needle that is positioned within the needle driver alignment channel.
- the closed clamping assembly preferably covers the tip for preventing exposure of the tip outside the clamping assembly.
- the closed clamping assembly may be used for lifting the suture needle out of the suture needle package.
- the closed clamping assembly may be used for passing the suture needle through a trocar.
- the suture needle is made of an elastic material such as a hyper-elastic material or a superelastic material (e.g., Nitinol).
- an elastic material such as a hyper-elastic material or a superelastic material (e.g., Nitinol).
- the suture needle preferably has a more curved configuration (e.g., a half-circle shape or higher profile) when secured to the suture needle package and a less curved configuration (e.g. a flatter shape or lower profile) during passing the suture needle through the trocar.
- a more curved configuration e.g., a half-circle shape or higher profile
- a less curved configuration e.g. a flatter shape or lower profile
- the suture needle may be loaded onto the needle driver using one hand.
- a system may include a suture needle package and a needle driver packaged together, whereby the needle driver is used for removing one or more suture needles or surgical needles from the package.
- the suture needle is preferably releasably secured to the suture needle package, such as by using one or more friction fit or snap-fit connectors that engage the outer surface of the suture needle.
- the needle driver may have elongated shafts having different outer diameters or widths of about 3-8 mm and more preferably about 5 mm.
- the suture needle package, the suture needle, and the needle driver are preferably sterilizable, biocompatible, and stable.
- a suture needle package preferably includes a needle driver guide channel that is configured to guide a needle driver into alignment with a distal tip of a suture needle that is releasably secured to the package.
- the suture needle package preferably includes one or more connectors that releasably secure a suture needle to the package, wherein the one or more connectors form a snap-fit, a friction fit, and/or a releasable connection with the suture needle so that the suture needle may be easily released from the package when secured by the needle driver.
- At least one of the connectors preferably orients the suture needle at a preferred angle relative to the needle driver and the needle driver guide channel.
- a resilient element or spring may be disposed within the needle driver guide channel for urging an elongated shaft of a needle driver against an opposite guide wall of the needle driver guide channel.
- the resilient element or spring takes up the slack or space to engage the elongated shaft, which makes sure that different sized needle holders will align with the tip of the suture needle with the tip not protruding outside the clamping jaws of the needle driver.
- the needle driver guide channel may include a hard stop or a tactile indicator that aids a surgeon to align the clamping assembly with the tip of the suture needle.
- the needle driver alignment guide has a low profile so that is may be integrated into existing suture needle package designs.
- the needle driver alignment guide may have an open window on top to access the needle tip in the suture needle package. In one embodiment, the needle driver alignment guide may have an opening on the side for accessing the tipoff the suture needle.
- the needle driver alignment guide preferably enables a needle holder to be consistently aligned with the tip of the suture needle, for clamping onto a tapered section of the needle that is proximal to the tip, without exposing the tip to possible damage during transfer through a trocar.
- the angle of the needle relative to the long axis of the needle driver may be controlled to minimize the amount of force that is required to advance (e.g., push, pull) the suture needle force through a trocar.
- the suture needle may be lifted from the suture package for direct introduction through the trocar.
- direct loading of the suture needle from the suture package prevents accidental stabbing of surgical personnel.
- obtaining access to the suture needle may be possible through either the top or the side of the suture needle package.
- the needle driver guide channel may be made of paper, which may also be used to control moisture levels within a suture needle package.
- the needle driver alignment guide is visible to a surgeon (e.g., visible on a top side of a suture needle package) to provide a simple, intuitive design for securing the tip of a suture needle with a needle driver or clamping element.
- a needle driver alignment guide may be readily incorporated into an existing design for a suture needle package without requiring modification of the existing design.
- the needle driver guide channel preferably controls the direction and the angle of the needle holder relative to the tip and the tapered section of the suture needle when loading the suture needle.
- the inside geometry of the needle driver guide channel desirably matches the geometry of the needle holder.
- the needle driver alignment guide preferably stops the introduction of the needle holder when the tip of the needle is aligned with the jaws of the clamping assembly.
- FIG. 1A is a side view of a suture needle having a proximal end and a distal end with a tapered section and a distal tip, in accordance with one embodiment of the present patent application.
- FIG. 1B is a magnified view of the tapered section and the distal tip of the suture needle shown in FIG. 1A .
- FIG. 2A is a perspective view of a needle driver having an elongated shaft with a proximal end, a distal end, and a clamping assembly at the distal end of the elongated shaft, the clamping assembly including lower and upper jaws moveable between open and closed positions, in accordance with one embodiment of the present patent application.
- FIG. 2B is a perspective view of the distal end of the elongated shaft and the clamping assembly of the needle driver shown in FIG. 2A .
- FIG. 3 shows a suture needle package for a suture needle including a needle driver alignment guide, in accordance with one embodiment of the present patent application.
- FIG. 4 is a top plan view of a suture needle package having a needle driver alignment guide that guides a distal end of the needle driver into alignment with a tip of a suture needle, in accordance with one embodiment of the present patent application.
- FIG. 5A shows a tip of a suture needle aligned with the lower and upper jaws of the clamping assembly of the needle driver of FIGS. 2A and 2B , in accordance with one embodiment of the present patent application.
- FIG. 5A-1 shows the suture needle and the needle driver of FIG. 5A with the upper jaw of the clamping assembly removed.
- FIG. 5B shows a perspective end view of the needle driver of FIG. 5A .
- FIG. 5C shows another perspective end view of the needle driver shown in FIG. 5A .
- FIG. 6 is a top plan view of a suture needle package for a suture needle, the suture needle package having a needle driver alignment guide, in accordance with one embodiment of the present patent application.
- FIG. 7 is a magnified view of the suture needle package and the needle driver alignment guide of FIG. 6 .
- FIG. 8A shows the clamping assembly of the needle driver of FIGS. 2A and 2B in a closed position for securing the tip of a suture needle, in accordance with one embodiment of the present patent application.
- FIG. 8B shows the needle driver of FIG. 8A removing the suture needle from the suture needle package, in accordance with one embodiment of the present patent application.
- FIG. 9A shows a stage of a method of using a needle driver to advance an elastic suture needle toward a distal end of a trocar, in accordance with one embodiment of the present patent application.
- FIG. 9B shows the needle driver and the elastic suture needle of FIG. 9A after the suture needle has been advanced beyond the distal end of the trocar for being located at a surgical site, in accordance with one embodiment of the present patent application.
- FIG. 9C shows a stage of a method of using a needle driver to retract an elastic suture needle from a surgical site and toward a proximal end of the trocar, in accordance with one embodiment of the present patent application.
- FIG. 9D shows a later stage of a method of retracting the elastic suture needle toward the proximal end of the trocar, in accordance with one embodiment of the present patent application.
- FIG. 10A is a perspective view of a suture needle package having a needle driver alignment guide, in accordance with one embodiment of the present patent application.
- FIG. 10B is a top plan view of the suture needle package shown in FIG. 10A .
- FIG. 10C is a perspective end view of the suture needle package shown in FIGS. 10A and 10B .
- FIG. 10D is another perspective view of the suture needle package shown in FIGS. 10A-10C .
- FIG. 11A is a perspective view of the suture needle package of FIGS. 10A-10D and a suture needle secured to the suture needle package, in accordance with one embodiment of the present patent application.
- FIG. 11B is a top plan view of the suture needle package and the suture needle shown in FIG. 11A .
- FIG. 11C is a perspective end view of the suture needle package and the suture needle shown in FIGS. 11A and 11B .
- FIG. 11D is a magnified view of a distal end of the suture needle package and the suture needle shown in FIGS. 11A-11C .
- FIG. 12 is a perspective view of a base of a suture needle package, in accordance with one embodiment of the present patent application.
- FIG. 13A is a perspective view of a needle driver alignment guide for a suture needle package, in accordance with one embodiment of the present patent application.
- FIG. 13B is a top plan view of the needle driver alignment guide shown in FIG. 13A .
- FIG. 13C is a perspective end view of the needle driver alignment guide shown in FIGS. 13A and 13B .
- FIG. 14A shows the needle driver alignment guide of FIGS. 13A-13C secured atop the base of FIG. 12 , with a suture needle secured over the needle driver alignment guide, in accordance with one embodiment of the present patent application.
- FIG. 14B is a top plan view of the base, the needle driver alignment guide, and the suture needle shown in FIG. 14A .
- FIG. 14C is a magnified view of the needle driver alignment guide and the suture needle shown in FIGS. 14A and 14B .
- FIG. 14D is a top plan view of the needle driver alignment guide and the suture needle shown in FIG. 14C .
- FIG. 15A is a perspective end view of a base of a suture needle package, in accordance with one embodiment of the present patent application.
- FIG. 15B is another perspective end view of the base of the suture needle package shown in FIG. 15A .
- FIG. 16A is a perspective view of a needle driver alignment guide, in accordance with one embodiment of the present patent application.
- FIG. 16B is a top plan view of the needle driver alignment guide shown in FIG. 16A .
- FIG. 17A is a perspective view of the base of FIGS. 15A-15B and the needle driver alignment guide of FIGS. 16A-16B assembled with the base, in accordance with one embodiment of the present patent application.
- FIG. 17B shows a magnified view of a distal end of the base and the needle driver alignment guide shown in FIG. 17A .
- FIG. 18A is a top plan view of the distal end of the base and the needle driver alignment guide of FIG. 17B with a tip of a suture needle aligned with the needle driver alignment guide, in accordance with one embodiment of the present patent application.
- FIG. 18B is a magnified view of the tip of the suture needle and the needle driver alignment guide of FIG. 18A .
- FIG. 19A is a perspective view of a method of using a needle driver to remove a suture needle from a suture needle package, in accordance with one embodiment of the present patent application.
- FIG. 19B is a top plan view of the needle driver, the suture needle package and the suture needle shown in FIG. 19A .
- FIG. 19C is a perspective end view of the needle driver, the suture needle package and the suture needle shown in FIGS. 19A and 19B .
- FIG. 19D is another perspective end view of the needle driver, the suture needle package and the suture needle shown in FIGS. 19A-19C .
- FIG. 19E is an end view of needle driver, the suture needle package and the suture needle shown in FIGS. 19A-19D .
- FIG. 19F is a top plan view of the needle driver, the suture needle package and the suture needle shown in FIGS. 19A-19E with an upper jaw of a clamping assembly removed to show the tip of the suture needle alignment with a top surface of a lower jaw, in accordance with one embodiment of the present patent application.
- FIG. 20A shows a first stage of a method of aligning a distal end of a needle driver with a tip of a suture needle, in accordance with one embodiment of the present patent application.
- FIG. 20B shows a second stage of a method of aligning a distal end of a needle driver with a tip of a suture needle, in accordance with one embodiment of the present patent application.
- FIG. 21 shows a top plan view of a suture needle package having a needle driver alignment guide and a tip of a suture needle positioned within the needle driver alignment guide, in accordance with one embodiment of the present patent application.
- FIG. 22 shows a side view of a suture needle having a bendable region for bending the suture needle into a seagull shaped configuration, in accordance with one embodiment of the present patent application.
- FIG. 23 shows a side view of a suture needle having a bendable region for bending the suture needle into a seagull shaped configuration, in accordance with one embodiment of the present patent application.
- FIG. 24 shows a side view of a suture needle having a bendable region for folding the suture needle in half so that the tip is adjacent the proximal end of the suture needle, in accordance with one embodiment of the present patent application.
- FIG. 25 shows a side view of a suture needle having a bendable region for folding the suture needle in half do that the tip is adjacent the proximal end of the suture needle, in accordance with one embodiment of the present patent application.
- a suture needle 100 preferably includes an elongated body 102 having an outer surface 104 that extends from a proximal end 106 to a distal end 108 of the suture needle.
- the suture needle 100 is preferably made of an elastic, hyper-elastic, or superelastic material, such as Nitinol, whereby an external force may be applied to the suture needle to elastically deform the suture needle, and the suture needle will spring back to its original shape and/or configuration when the external force is removed.
- the elongated body 102 of the suture needle 100 is curved and may have a semi-circular or circular shaped segment.
- the suture needle defines a half circle or semi-circle. In one embodiment, the suture needle defines 1 ⁇ 4 of a circle, 3 ⁇ 8 th of a circle, 5 ⁇ 8 th of a circle, 3 ⁇ 4 of a circle, etc.
- the suture needle 100 preferably includes a suture attachment barrel 110 that is located at the proximal end 106 of the elongated body 102 , which preferably has a suture attachment opening formed in a proximal face thereof.
- a distal end of a surgical suture may be inserted into the suture attachment opening of the suture attachment barrel 110 and the barrel may be swaged for securing the surgical suture to the proximal end 106 of the suture needle 100 .
- the distal end 108 of the suture needle 100 preferably includes a tapered section 112 that tapers inwardly to a tip 114 that is located at a distal-most end of the suture needle.
- the tip 114 may be sharpened for piercing tissue to facilitate passing the suture needle through tissue during a suturing operation.
- the suture needle may have a bendable region or may be highly elastic for changing shape and/or configuration to fit through a trocar (e.g., a 5 mm trocar), as disclosed in commonly assigned U.S. patent application Ser. Nos. 16/282,604, filed on Feb. 22, 2019, published as US 2020/0268378 (Attorney Docket Number ETH6024USNP1), 16/282,652, filed on Feb. 22, 2019, published as US 2020/0268379 (Attorney Docket Number ETH6025USNP1), and Ser. No. 16/781,055, filed on Feb. 4, 2020, which claims benefit of U.S. Provisional Application No. 62/809,016, filed on Feb. 22, 2019, and now published as US 2020/0268380 (Attorney Docket Number ETH6026USNP1), the disclosures of which are hereby incorporated by reference herein.
- a trocar e.g., a 5 mm trocar
- a clamping element such as a needle driver 116 may be utilized for securing a suture needle, such as the suture needle 100 shown in FIGS. 1A and 1B , to remove the suture needle from a suture needle package and advance the clamped suture needle through a trocar to a surgical site for performing a suturing operation.
- the shape of the suture needle may change as the needle driver 116 advances the suture needle through the trocar.
- the suture needle may be a superelastic suture needle that normally has a semi-circular shape with a first height.
- the suture needle will flatten out or become straighter along at least one segment for assuming a smaller, second height for fitting through the smaller trocar.
- the superelastic suture needle Upon being extracted from the end of the trocar, the superelastic suture needle will preferably return (e.g., spring back) to its original first height and the original semi-circular shape.
- the needle driver 116 preferably includes an elongated shaft 118 having a proximal end 120 and a distal end 122 including a clamping assembly 124 that is movable between open and closed positions.
- the clamping assembly 124 preferably includes a lower jaw 126 and an opposing upper jaw 128 that is movable between open and closed positions. In one embodiment, with the clamping assembly 124 in the open position, the lower and upper jaws 126 , 128 may be guided into alignment with a tip of a suture needle.
- the jaws may be moved to the closed position for clamping and/or gripping the tapered section of the suture needle with the tip positioned between and surrounded by the opposing lower and upper jaws.
- the lower jaw 126 may be stationary and/or rigidly secured to the distal end 122 of the elongated shaft 118 of the needle driver 116 so that the lower jaw 126 is fixed and does not move relative to the distal end 122 of the elongated shaft 118 of the needle driver 116 .
- the lower jaw 126 preferably includes a substantially flat top surface 130 that is adapted to be aligned with the tip 114 ( FIG. 1B ) that is located at the distal end of the suture needle.
- the substantially flat top surface 130 of the lower jaw 126 may include a surface roughening such as knurling for enhancing gripping of the tapered section 112 ( FIG. 1B ) of the suture needle when the clamping assembly 124 is in the closed position.
- the upper jaw 128 of the clamping assembly 124 is desirably pivotally secured to the distal end 122 of the elongated shaft 118 of the needle driver 116 via a pivot 132 , which pivotally secures a proximal end of the upper jaw 128 to the distal end 122 of the elongated shaft 118 .
- the upper jaw 128 preferably includes a substantially flat bottom surface 132 that opposes the substantially flat top surface 130 of the lower jaw 126 .
- the substantially flat bottom surface 134 of the upper jaw 128 may include surface roughening such as knurling for gripping the tapered section 112 ( FIG. 1B ) of a suture needle when the clamping assembly 124 is in the closed position.
- the top surface 130 of the lower jaw 126 and the bottom surface 134 of the upper jaw 128 preferably engage the tapered section of the suture needle that is located between the jaws, however, the top and bottom surfaces of the jaws are spaced away from the tip so that the tip is not marred or dulled by the jaws of the clamping assembly.
- a suture needle package 136 preferably holds a suture needle 100 , such as the suture needle shown in FIGS. 1A and 1B , so that the tip 114 of the suture needle 100 is pre-positioned at a location that will facilitate aligning the tip 114 of the suture needle 100 between the top and bottom surfaces 130 , 134 of the respective upper and lower jaws 126 , 128 of the clamping assembly 124 of the needle driver 116 .
- the suture needle package 136 preferably includes a needle driver alignment guide 138 having a first lateral guide wall 140 and an opposing second lateral guide wall 142 that preferably engage the lateral sides of the elongated shaft 118 of the needle driver 116 ( FIG. 2A ) for guiding the clamping assembly of the needle driver in the direction designated DIR 1 for aligning the lower and upper jaws of the clamping assembly 124 with the tip 114 of the suture needle 100 to ensure that the tip 114 is positioned between the top and bottom surfaces of the respective upper and lower jaws of the clamping assembly.
- the first and second lateral guide walls 140 , 142 define a needle driver guide channel 143 , which preferably aligns the needle driver with the tip 114 as the needle driver moves in the direction DIR 1 toward the tip 114 .
- the suture needle package 136 preferably includes one or more releasable connectors that releasably secure the suture needle to the suture needle package.
- the one or more releasable connectors desirably hold the tip 114 of the suture needle 100 at a known location having three dimensions, between the first lateral guide wall 140 and the opposing second lateral guide wall 142 so that jaws of the clamping assembly 124 may be consistently aligned with the tip 114 as the needle driver 116 is advanced in the direction designated DIR 1 through the needle driver guide channel 143 defined by the needle driver alignment guide 138 .
- the needle driver 116 preferably includes the elongated shaft 116 having an outer diameter OD 1 that closely matches the width W 1 of the needle driver alignment guide 138 , which is preferably defined as the distance between the first lateral guide wall 140 and the opposing second lateral guide wall 142 .
- a resilient element e.g., a foam strip, a spring
- the needle driver alignment guide for engaging the side of the elongated shaft for urging the shaft against one of the first and second lateral guide walls.
- the needle driver alignment guide preferably has a depth that is about equal to 1 ⁇ 2 the diameter of the elongated shaft 118 of the needle driver 116 so that the space between the opposing lower and upper jaws is aligned with the tip 114 of the suture needle.
- the clamping assembly 124 will preferably advance distally until a distal-most end of the lower jaw 126 abuts against a hard stop 144 that is located at a distal end of the needle driver alignment guide 138 . In one embodiment, when the distal-most end of the lower jaw 126 abuts against the hard stop 144 , the flat top surface 130 of the lower jaw 126 is preferably aligned with the tip 114 of the suture needle 100 .
- the needle driver alignment guide preferably controls the position of the lower and upper jaws along respective X, Y and Z axes to ensure that the tip is consistently and repeatedly positioned between the opposing clamping faces of the lower and upper jaws.
- the top surface 130 of the lower clamping jaw 126 has a length L 1 that is greater than the distance L 2 between the tip 114 and the proximal face of the hard stop 144 , which ensures that the tip 114 will be located between the proximal and distal ends 131 , 133 of the top surface 130 of the lower jaw 126 .
- the tip 114 will generally be aligned midway between the proximal and distal ends 131 , 133 of the top surface 130 of the lower jaw 126 .
- similar dimensions are provided for the bottom surface of the upper jaw to insure that the tip is positioned approximately midway between the proximal and distal ends of the upper jaw of the clamping assembly.
- the upper jaw of the clamping assembly 124 may be moved to the closed position for engaging the tapered section 112 of the suture needle 100 to secure the tip 114 of the suture needle 100 between the lower and upper jaws of the needle driver 116 .
- the clamping faces of the lower and upper jaws do not contact the tip, but rather clamp onto the thicker, tapered section of the suture needle to avoid damaging or dulling the tip.
- the needle driver 116 preferably includes the elongated shaft 118 having a longitudinal axis A 1 that extends between the proximal and distal ends of the elongated shaft 118 .
- the tapered section 112 of the suture needle 100 preferably extends along an axis A 1 ′ that defines an angle ⁇ 1 that is less than 90 degrees relative to the longitudinal axis A 1 of the elongated shaft 118 of the needle driver 116 . Holding the suture needle 100 at an angle that is less than 90 degrees preferably minimizes the amount of force that is required when using the needle driver to push or pull the suture needle though a trocar.
- the needle driver alignment guide 138 ( FIGS. 3 and 4 ) preferably aligns the clamping assembly 124 of the needle driver 116 with the tip 114 of the suture needle 100 along the X, Y, and Z axes.
- the tip 114 is preferably disposed between the top surface 130 of the lower jaw 126 and the bottom surface 134 of the upper jaw 128 of the clamping assembly 124 .
- the elongated body 102 of the suture needle 100 preferably extends proximally toward the proximal end of the elongated shaft 118 of the needle driver 116 .
- the engagement of the needle driver with the needle driver alignment guide insures that the tip 114 of the suture needle 100 is preferably aligned between the top and bottom surfaces 130 , 134 of the respective lower and upper jaws 126 , 128 so that the tip 114 is not exposed and/or does not extend beyond or outside the lateral sides 127 , 129 of the respective lower and upper jaws 126 , 128 .
- Aligning the tip 114 of the suture needle 100 between the lower and upper jaws so that the tip 114 it is not exposed outside the jaws of the clamping assembly 124 will desirably protect the tip 114 as the needle driver 116 advances the suture needle 100 through a trocar. As a result, the protected tip will not be exposed and will not scratch the inside of the trocar, which could weaken, dull and/or damage the tip.
- the tapered section 112 of the suture needle 100 tapers inwardly toward the tip 114 that is located at the distal end of the suture needle 100 .
- the tapered section 112 of the suture needle becomes thinner toward the tip 114 .
- the clamping assembly 124 when the clamping assembly 124 is closed, the opposing top and bottom surfaces of the respective lower and upper jaws 126 , 128 engage a thicker portion of the tapered section 112 of the suture needle so that the tip 114 is not engaged by the opposing faces of the lower and upper jaws.
- the clamping jaws provide a protective shroud or barrier around the tip of the suture needle, however, the clamping surfaces of the lower and upper jaws do not directly contact or engage the tip of the suture needle.
- a suture needle package 236 preferably includes a base 250 having a top surface 252 that is adapted to secure a suture needle 200 over the top surface 252 .
- the suture needle package 236 preferably has a proximal end 254 , a distal end 256 , and a longitudinal axis A 2 that desirably extends from the proximal end 254 to the distal end 256 of the package.
- the suture needle package 236 desirably includes a needle driver alignment guide 238 that preferably extends along the longitudinal axis A 2 of the base of the suture needle package 236 .
- the needle driver alignment guide desirably includes a first lateral guide wall 240 , a second lateral guide wall 242 that opposes the first lateral guide wall 240 , and an end wall 244 that preferably functions at a hard stop for halting distal movement of a needle driver through the needle driver alignment guide 238 .
- the first and second lateral guide walls and the end wall preferably define the boundaries of a needle driver guide channel 243 provided on the suture needle package.
- the needle driver alignment guide 238 defines a width W 2 that extends laterally between opposing inner surfaces of the first lateral guide wall 240 and the second lateral guide wall 242 .
- the width W 2 preferably equals the distance between inner surfaces of the first and second lateral guide walls 240 , 242 .
- the suture needle 200 is secured over a top of the suture needle package 236 so that the tip 214 at a distal-most end of the suture needle 200 is positioned between the first lateral guide wall 240 , the second lateral guide wall 242 , and the end wall 244 that functions as a hard stop.
- a gap G is present between the tip 214 and the inner surface of the second lateral guide wall 242 .
- the tip 214 is preferably spaced away from the inner surface 245 ( FIG. 7 ) of the second lateral guide wall 242 by a distance that is preferably less than 1 ⁇ 2 the distance defined by the width W 2 of the needle driver alignment guide.
- the tip 214 is spaced proximally from the end wall 244 by a distance L 3
- the suture needle package 236 preferably includes a proximal connector 260 that releasably secures a proximal section of the suture needle 100 over the top surface 252 of the suture needle package, and a distal connector 262 that preferably secures a distal section of the suture needle 200 over the top surface 252 of the suture needle package 236 .
- the proximal and distal connectors 260 , 262 preferably form a releasable, friction fit, and/or snap-fit connection with the elongated body 202 of the suture needle 200 so that the suture needle 200 may be selectively detached and removed from the suture needle package 236 .
- the proximal and distal connectors 260 , 262 desirably hold the suture needle 100 in place within the package and prevent the suture needle from shifting or being loose during initial packaging, shipment, and storage of the suture needle.
- the needle driver alignment guide 238 preferably includes the end wall 244 that interconnects distal ends of the respective first and second lateral guide walls 240 , 242 .
- the end wall 244 preferably functions as a hard stop for abutting against a distal-most end of the needle driver as the needle driver is advanced through the needle driver alignment guide 238 in the direction DIR 1 .
- the top surface of the lower jaw is preferably aligned with the tip 214 of the suture needle 200 and the bottom surface of the upper jaw is also preferably aligned with and overlies the tip of the suture needle.
- the suture needle guide channel 238 preferably has depth that aligns the lower jaw below the tip 214 and the upper jaw above the tip.
- the suture needle package 236 may include a resilient element 264 (e.g., a foam strip, one or more springs) that desirably abuts against a side of the elongated shaft of the needle driver 116 ( FIG. 2A ) for pressing the elongated shaft against the inner surface 243 of the second lateral guide wall 242 , which insures that the opposing top and bottom surfaces of the respective lower and upper jaws of the clamping assembly remain aligned with the tip 214 of the suture needle 200 .
- a resilient element 264 e.g., a foam strip, one or more springs
- the resilient element 264 may be a strip of foam that is adapted to press against a lateral side of the elongated shaft of the needle driver for urging the elongated shaft and the clamping assembly to abut against the second lateral guide wall 242 .
- the resilient element 264 may include one or more springs that press against a lateral side of the elongated shaft of the needle driver.
- the elongated shaft 218 of the needle driver 216 is preferably advanced through the needle driver alignment guide 238 in the direction DIR 1 for engaging the tip 214 ( FIG. 7 ) located at the distal-most end of the suture needle 200 .
- the resilient element 264 positioned between the first and second lateral guide walls 240 , 242 of the needle driver alignment guide 238 desirably urges the elongated shaft 218 against the inner surface 243 of the second lateral guide wall 242 so that the clamping assembly 224 is aligned with the tip 214 ( FIG. 7 ) at the distal-most end of the suture needle 200 .
- the clamping assembly 224 may be closed for pinching the tapered section 212 of the suture needle 200 between the opposing top and bottom surfaces of the respective lower and upper jaws 226 , 228 .
- the tip 214 ( FIG. 7 ) of the suture needle is preferably surrounded by the lower and upper jaws of the clamping assembly so that the tip is not exposed outside the perimeter of the lower and upper jaws.
- the clamped suture needle 200 may be lifted away from the top surface 252 of the suture needle package 236 for uncoupling the elongated body 202 from the proximal and distal connectors 260 , 262 ( FIG. 7 ) provided on the top surface 252 of the suture needle package 236 .
- the needle driver 216 may be utilized for advancing the suture needle 200 through a trocar for positioning the suture needle at a surgical site for performing a suturing operation.
- a trocar 266 preferably has an elongated conduit 268 defining an inner diameter that extends to an opening at a distal end 270 of the trocar.
- the clamping assembly 224 of the needle driver 216 is preferably advanced through the conduit 268 of the trocar 266 for pulling the needle 200 through the trocar.
- the elongated body 202 of the superelastic suture needle 200 preferably elastically deforms (e.g., straightens out, becomes flatter) as shown in FIG. 9A .
- the elastic suture needle 200 preferably returns to the original curved configuration (e.g., a half circle shape). Surgical personnel may then utilize the curved suture needle 200 for performing a suturing operation at the surgical site.
- the original curved configuration e.g., a half circle shape
- the suture needle 200 may be removed from a patient by retracting the suture needle through the trocar 260 .
- the clamping assembly 224 is again closed for securing the tip of the curved suture needle 200 between the lower jaw 226 and the upper jaw 228 of the needle driver 216 .
- the suture needle 200 is retracted through the cannula 268 of the trocar 266 .
- the superelastic suture needle 200 preferably straightens out as it is retracted through the trocar by the clamping assembly 224 of the needle driver 216 .
- the lower and upper jaws 226 , 228 preferably engage the tapered section of the suture needle 200 and surround the tip.
- a suture needle package 336 adapted to hold at least one suture needle preferably has a proximal end 354 , a distal end 356 and a longitudinal axis A 3 that extends along the length of the suture needle package 336 between the proximal end 354 and the distal end 356 .
- the suture needle package 336 preferably includes a needle driver alignment guide 338 that extends along the longitudinal axis A 3 of the suture needle package 336 .
- the needle driver alignment guide 338 preferably includes a first lateral guide wall 340 and an opposing second lateral guide wall 342 that desirably define a needle driver guide channel 343 for guiding advancement of a needle driver toward the distal end 352 of the suture needle package 336 .
- the needle driver alignment guide 338 preferably includes an end wall 344 that functions as a hard stop for halting distal movement of the jaws of a needle driver through the needle driver alignment channel.
- the suture needle package 336 preferably includes a proximal connector 360 that is adapted to form a releasable connection with a proximal end of a suture needle, and a lateral connector 362 that is adapted to form a releasable connection with a more distal section of the suture needle.
- the suture needle package 336 also preferably includes a securing notch 365 formed at an upper end of the first lateral guide wall 340 that is adapted to form a releasable connection with a tapered section of a suture needle.
- the securing notch 365 is preferably spaced a distance L 4 from the end wall 344 of the needle driver alignment guide 338 .
- a suture needle 300 may be secured to the suture needle package 336 so that the tip 314 of the suture needle 300 is positioned between the first and second lateral guide walls 340 , 342 and the end wall 344 of the needle driver alignment guide 338 .
- the tip 314 of the suture needle 300 is spaced away from the inner face 343 of the second lateral guide wall 342 so that a gap G is present between the tip 314 and the second lateral guide wall 342 .
- the tip 314 is preferably held proximal to the end wall 344 by a distance L 4 .
- the distance L 4 is preferably less than the length of the top surface of the lower jaw of the needle driver, and is more preferably equal to about one half of the length of the top surface of the lower jaw of the clamping assembly, which insures alignment of the top surface of the lower jaw with the tip of the suture needle.
- the proximal end 306 of the suture needle 300 is releasably secured to the proximal connecter 360 of the suture needle package 336 .
- a mid-section of the suture needle 300 is releasably secured to the lateral connector 362 of the suture needle package 336 .
- the tapered section 312 of the suture needle 300 is releasably secured to the securing notch 365 provided at the upper end of the first lateral guide wall 340 of the needle driver alignment guide 338 .
- the securing notch 365 desirably holds the tip 314 of the suture needle 300 at a known location having X, Y, and Z coordinates.
- a suture needle package 436 preferably includes a base 452 having a proximal end 454 , a distal end 456 , and a longitudinal axis A 4 that extends from the proximal end 454 to the distal end 456 of the base 452 .
- the base 452 has a top surface 470 that is adapted to seat a needle driver alignment guide that holds a suture needle.
- a suture needle platform 472 preferably has a top surface 474 that extends from a proximal end 476 to a distal end 478 of the suture needle platform 472 .
- the suture needle platform 472 preferably includes a curved groove 480 that is adapted to receive and/or releasably secure a suture needle over the top surface 474 of the suture needle platform 472 .
- the curved groove 480 preferably has a proximal end 482 that is adapted to receive a proximal end of a curved suture needle and a distal end 484 that is adapted to receive a distal section of the curved suture needle.
- the curved groove 480 preferably includes a resilient element 486 that is desirably adapted to engage the elongated body of a suture needle for releasably securing a curved suture needle within the curved groove 480 of the suture needle platform 472 .
- the suture needle platform 472 preferably includes a needle driver alignment guide 438 that is formed in the top surface 474 of the suture needle platform 472 .
- the needle driver alignment guide 438 preferably has a first lateral guide wall 440 , an opposing second lateral guide wall 442 , and an end wall 444 that functions as a hard stop at a distal-most end of the needle driver alignment guide.
- the needle driver alignment guide 438 preferably has a proximal end 488 that is located closer to the proximal end 476 of the suture needle platform 472 and a distal end 490 that is located at the end wall 444 of the needle driver alignment guide 438 .
- the needle driver alignment guide 438 preferably includes a floor 492 that may slope downwardly from the top surface 474 toward the end wall 444 .
- the needle driver alignment guide 438 preferably extends along a longitudinal axis A 5 .
- the suture needle platform 472 is preferably assembled over the top surface 470 of the base 452 of the suture needle package 436 .
- the longitudinal axis A 5 of the needle driver alignment guide 438 is preferably co-axial with and extends along the longitudinal axis A 4 of the base 452 of the suture needle package 436 .
- a suture needle 400 is preferably secured within the curved groove 480 provided in the top surface 474 of the suture needle platform 472 .
- the curved groove 480 preferably holds the tip 414 of the suture needle 400 within the needle driver alignment guide 438 so that the tip 414 is preferably spaced away from the second lateral guide wall 442 of the needle driver alignment guide 438 , whereby a gap G is present between the tip 414 and the inner surface of the second lateral guide wall 442 .
- the tip 114 is desirably spaced proximally from the end wall 444 of the needle driver alignment guide 438 by a distance L 5 .
- a distal end of the needle driver 116 may be advanced from the proximal end 488 to the distal end 490 of the needle driver alignment guide 438 until a distal-most end of the clamping assembly abuts against the end wall 444 of the needle driver alignment guide 438 .
- the opposing top and bottom surfaces of the respective lower and upper jaws of the clamping assembly are preferably aligned with the tip 414 of the suture needle 400 .
- the lower and upper jaws of the clamping assembly may be moved to the closed position for engaging (e.g., clamping) the tapered section 412 of the suture needle 400 .
- the needle driver may be used to remove the clamped suture needle 400 from the resilient connection 486 of the suture needle platform 472 , whereupon the suture needle 400 may be extracted from the curved groove 480 formed in the top surface 474 of the suture needle platform 472 .
- the needle driver may be utilized for advancing (e.g., pulling) the clamped suture needle 400 through a trocar to deliver the suture needle at a surgical site for performing a suturing operation.
- a suture needle package 536 preferably includes a base 552 having a proximal end 554 , a distal end 556 and a longitudinal axis A 6 that extends from the proximal end 554 to the distal end 556 .
- the base 552 may include a proximal gap 575 formed therein at the proximal end 554 of the base 552 , which is adapted to receive a needle driver alignment guide, as will be described in more detail below.
- a needle driver alignment guide 538 preferably has a first lateral guide wall 540 and an opposing second lateral guide wall 542 that extend from a proximal end 588 to a distal end 590 of the needle driver alignment guide.
- the needle driver alignment guide 538 preferably has a longitudinal axis A 7 that extends from the proximal end 588 to the distal end 590 of the needle driver alignment guide.
- the needle driver alignment guide 538 preferably includes an end wall 588 that extends between distal ends of the respective first and second lateral guide walls 540 , 542 .
- the end wall 588 desirably functions as a hard stop for aligning the clamping jaws of a needle driver with a tip of a suture needle.
- the first and second lateral guide walls 540 , 542 preferably define a needle driver guide channel that guides advancement of the jaws of a needle driver from the proximal end 588 to the distal end 590 of the needle driver alignment guide 538 so that the jaws may be properly aligned with a tip of a suture needle, as will be described in more detail herein.
- the needle driver alignment guide 538 is preferably assembled with the base 552 by inserting the needle driver alignment guide into the gap 575 located at the distal end 556 of the base 552 of the suture needle package 536 .
- the longitudinal axis A 7 of the needle driver alignment guide 538 preferably extends along the longitudinal axis A 6 of the base 552 .
- a suture needle 500 may be secured over the base 552 of the suture needle package 536 so that the tip 514 at the distal-most end of the suture needle 500 is located between the first and second lateral guide walls 540 , 542 and is proximal to the end wall 544 of the needle driver alignment guide 538 .
- the tip 514 is secured to the suture needle package 536 so that the tip 514 of the suture needle 500 is spaced away from the inner surface 543 of the second lateral guide wall 542 .
- the tip 514 of the suture needle 500 is preferably located proximal to the end wall 544 of the needle driver alignment guide 538 so that a gap exists between the end wall 544 and the tip 514 of the suture needle 500 .
- the needle driver 116 having the clamping assembly 124 located at the distal end 122 of the elongated shaft 118 may be utilized for removing the suture needle 500 from the suture needle package 536 .
- the elongated shaft 118 of the needle driver 116 has an outer diameter OD 1 that substantially matches the width W 4 of the guide channel that extends between the first lateral guide wall 540 and the second lateral guide wall 542 of the needle driver alignment guide 538 .
- the needle driver 116 is preferably advanced between the first and second lateral guide walls 540 , 542 in the direction designated DIR 1 until the distal end of the lower jaw of the clamping assembly 124 abuts against the end wall 544 of the needle driver alignment guide 538 .
- the top and bottom surfaces 530 , 534 of the respective lower and upper jaws 526 , 528 are preferably aligned with the tip 514 of the suture needle 500 .
- the top and bottom surfaces 530 , 534 of the opposing jaws 526 , 528 desirably have respective lengths that are greater than the distance between the tip 514 of the suture needle and the end wall 544 of the needle driver alignment guide 538 so that the tip 514 of the suture needle is located between the proximal and distal ends of the clamping surfaces and inside the lateral boundaries of the lower and upper jaws.
- the tip 514 of the suture needle 500 is positioned inside the lateral wall 527 of the lower jaw 526 and is spaced proximally from the end wall 544 so that the tip 514 of the suture needle 500 is not exposed and does not extend outside the perimeter of the lower and upper jaws of the clamping assembly 524 .
- the tip 514 is protected and surrounded by the lower and upper jaws as the needle driver pulls the suture needle 500 through a trocar for positioning the suture needle at a surgical site.
- the needle driver alignment guide 538 has a first lateral guide wall 540 having a lower end 545 and an upper end 555 that define a depth D 1 of the needle driver alignment guide.
- the upper end 555 of the first lateral guide wall 540 has a securing notch 565 formed therein for securing a tapered section of the suture needle so that the tip 514 ( FIG. 19F ) of the suture needle is located in the needle driver guide channel of the needle driver alignment guide 538 .
- the securing notch 565 spaces the tip 514 of the suture needle proximal to the end wall 544 of the needle driver alignment guide by a distance L 6 .
- the distal end of the needle driver 516 may be advanced distally in the direction DIR 1 until the distal end of the lower jaw 526 of the clamping assembly 524 engages the end wall 544 ( FIG. 20B ), which preferably provides tactile feedback to a surgeon that the clamping assembly has reached the end of the needle driver guide channel and is aligned with the tip 514 of the suture needle.
- the top surface 530 of the lower jaw 526 is preferably aligned with the tip 514 of the suture needle.
- the top surface 530 of the lower jaw 526 preferably has a length L 7 that is greater than the distance L 6 between the tip 514 of the suture needle and the end wall 544 of the needle driver alignment guide 538 so that the tip is positioned between the proximal and distal ends of the top surface 530 of the lower jaw 526 .
- the bottom surface 534 of the upper jaw 528 preferably has a similar length as the top surface of the lower jaw.
- the securing notch 565 holds the tip 514 at a known height that is between the lower end 545 and the upper end 555 of the first lateral guide wall 540 so that the top surface 530 of the lower jaw 526 is positioned under the tip 514 of the suture needle and the bottom surface 534 of the upper jaw 528 is positioned over the tip 514 of the suture needle.
- the suture needle package may be designed so that the tip of the suture needle is held at a predetermined location having known X, Y, and Z coordinates.
- the needle driver alignment guide and the needle driver may be designed to have dimensions to insure that the clamping surfaces of the needle driver jaw may be consistently and repeatedly aligned with the tip to ensure that the tip is protected and surrounded by the clamping assembly as the suture needle is passed through a trocar.
- a suture needle package 636 preferably includes a needle driver alignment guide 638 that extends along a longitudinal axis A 8 .
- the needle driver alignment guide 638 preferably includes a first lateral guide wall 640 , an opposing second lateral guide wall 642 , and an end wall 644 that interconnects distal ends of the first and second lateral guide wall 640 , 642 .
- the first and second lateral guide wall 640 , 642 and the end wall 644 preferably define a needle driver guide channel 643 that is configured to guide a needle driver so that the clamping jaws of the needle driver are aligned with the tip 614 of the suture needle 600 .
- the suture needle package 636 preferably includes a releasable connector 665 that secures a tapered section 612 of the suture needle 600 to the suture package so that the tip 614 is located within the elongated channel of the needle driver alignment guide 638 .
- the connector 665 preferably holds the suture needle 600 at a preferred orientation relative to the longitudinal axis A 8 so that the tapered section 612 of the suture needle extends along an axis A 9 that defines an angle ⁇ 2 of less than 90 degrees relative to the axis A 8 , which will require less force for passing the suture needle through a trocar.
- the jaws of a needle driver may be inserted into the slot at the proximal end 688 of the needle driver alignment guide 638 and advanced in the direction DIR 1 toward the end wall 644 at the distal end of the needle driver alignment guide 638 .
- the opposing top and bottom surfaces of the respective lower and upper jaws are preferably aligned with the tip 614 of the suture needle 600 .
- the jaws may be closed for clamping the tapered section and the tip 614 between the opposing jaws. Once the clamping assembly has been closed for clamping onto the tapered section 612 of the suture needle 600 , the needle driver may be lifted away from the suture package 636 to remove the suture needle from the suture package.
- the systems, suture packages, devices and methods disclosed herein may be used for passing suture needles having bendable or foldable regions through smaller trocars, whereby the suture needles are bent or folded to reduce their outer dimensions, heights, and/or profiles for being passed through trocars (e.g., a 5 mm trocar), as disclosed in commonly assigned U.S. Patent Application Ser. No. 16/282,604, filed on Feb. 22, 2019, published as US 2020/0268378 (Attorney Docket Number ETH6024USNP1), 16/282,652, filed on Feb. 22, 2019, published as US 2020/0268379 (Attorney Docket Number ETH6025USNP1), and Ser. No. 16/781,055, filed on Feb.
- suture needles 700 , 800 have bendable regions that enable the needles to be bent into seagull shaped configurations for being passed through smaller trocars. Referring to FIGS. 22 and 23 , in one or more embodiments, suture needles 700 , 800 have bendable regions that enable the needles to be bent into seagull shaped configurations for being passed through smaller trocars. Referring to FIGS. 22 and 23 , in one or more embodiments, suture needles 700 , 800 have bendable regions that enable the needles to be bent into seagull shaped configurations for being passed through smaller trocars. Referring to FIGS.
- suture needles 900 , 1000 have bendable regions that enable the needles to be folded in half so that the tips of the needles are adjacent the proximal ends of the needles for being passed through smaller trocars.
- the suture needles After being passed through trocars using the suture needle packages, needle driver guide channels, and needle drivers disclosed herein, the suture needles may be bent into a curved configuration (e.g., a half circle) for use in a suturing operation. At the conclusion of the suturing operation, the suture needles may be bent back into the configurations shown in FIGS. 22-25 for withdrawing the suture needles from the trocars.
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Abstract
Description
- This application is a continuation of U.S. application Ser. No. 16/282,901 filed Feb. 22, 2019 of which is incorporated by reference in its entirety.
- The present patent application is generally related to surgical procedures and surgical tools, and is more specifically related to systems, devices and methods for loading suture needles and passing suture needles through trocars.
- Surgeons use trocars to position surgical tools, such as suture needles, at surgical sites. The size of a suture needle (e.g., a needle attached to a suture) or a surgical needle (e.g., a needle not attached to a suture) that can be passed through the trocar to a surgical site is limited by the size of the opening in the trocar. In many instances, surgeons desire to use larger needles for closing surgical wounds and repairing anatomical features, however, passing larger needles through smaller trocars is difficult. For example, 5 mm trocars are often used during minimally invasive surgeries (MIS), however, surgeons cannot pass the larger suture needles through the 5 mm trocars so they are forced to use only smaller suture needles.
- The smaller suture needles are less than optimal because, inter alia, they often require a surgeon to make many more passes of the needle and suture through tissue, which lengthens the surgical procedure and can frustrate the surgeon. Using smaller needles may also produce a bite distance that puts the wound or anatomical feature at risk of dehiscence.
- In addition, larger-sized sutures cannot be easily attached to the smaller suture needles. Thus, when fine sutures are passed through tissue with a smaller bite size, a cheese wire effect may result, whereby the suture cuts through the tissue it is intended to hold.
- Thus, there is a need for improved suture needles that can be passed through relatively smaller trocars (e.g., 5 mm trocars) for use in surgical procedures. There is also a need for systems, packages, devices and methods for passing larger suture needles through relatively smaller trocars.
- As used herein, the terms surgical needle and suture needle are used interchangeably. A surgical needle may have a suture attached thereto or may not have a suture attached thereto. A suture needle may have a suture attached thereto or may not have a suture attached thereto. Regardless of whether the terms surgical needle or suture needle are used herein, the terms may be used to describe both needles having sutures attached thereto and needles that do not have sutures attached thereto.
- In one embodiment, a surgical needle or suture needle is preferably made of a hyper-elastic and/or or superelastic material, such as Nitinol. In one embodiment, the suture needle may be elastically deformed to lower the height and/or the profile of the suture needle to pass the suture needle through a trocar, such as a trocar having a diameter of 5 mm or smaller.
- In one embodiment, a needle driver may be used to secure a tapered section at a distal end of the suture needle with the barrel of the suture needle trailing behind the tip of the suture needle. In one embodiment, the tip is preferably surrounded by clamping jaws at the distal end of the needle driver for protecting the tip as the suture needle is passed through a trocar. The clamping jaws preferably surround and protect the tip for preventing the tip from contacting the inside of the trocar as it is passed through the trocar, which could damage the tip during its passage through the channel of the trocar.
- In one embodiment, when the suture needle is held by the needle driver, the tip of the needle does not extend or protrude outside the external surface of the needle holder.
- In one embodiment, a suture needle package preferably includes a base, and a needle driver alignment guide overlying the base, the needle driver alignment guide including first and second lateral guide walls that oppose one another for defining a needle driver guide channel.
- In one embodiment, a suture needle desirably overlies the base. The suture needle may include a proximal end and a distal end having a tapered section that terminates at a tip. In one embodiment, at least one connector releasably secures the suture needle over the base. In one embodiment, the at least one connector desirably orients the suture needle relative to the first and second lateral guide walls so that the tip of the suture needle is located within the suture needle guide channel and is bounded by the first and second lateral guide walls.
- In one embodiment, the needle driver guide channel preferably has a proximal end, a distal end, and a longitudinal axis that extends between the proximal and distal ends thereof.
- In one embodiment, the needle driver alignment guide may include an end wall interconnecting the first and second lateral guide walls for defining the distal end of the needle driver guide channel. In one embodiment, the end wall desirably interconnects distal ends of the first and second lateral guide walls. In one embodiment, the first and second lateral guide walls are desirably parallel to one another.
- In one embodiment, the end wall and the distal ends of the first and second lateral side walls preferably surround the tip of the suture needle.
- In one embodiment, each of the first and second lateral guide walls has a lower end and an upper free end, and the at least one connector holds the tip of the suture needle between the lower ends and the upper free ends of the respective first and second lateral guide walls.
- In one embodiment, the at least one connector preferably secures the tip of the suture needle closer to the distal end of the needle driver guide channel and secures the proximal end of the suture needle closer to the proximal end of the needle driver guide channel.
- In one embodiment, the at least one connector may include a securing notch formed in the upper free end of one of the first and second lateral guide walls. In one embodiment, the tapered section of the suture needle is seated in the securing notch and the tapered section extends proximally from the tip of the suture needle.
- In one embodiment, the tapered section of the suture needle preferably extends along an axis that defines an angle with the longitudinal axis of the needle driver alignment channel of less than 90 degrees, which preferably enables the suture needle to be passed through a trocar using less force.
- In one embodiment, the at least one connector may include a second connector that is located proximal to the securing notch for securing a section of the suture needle that is proximal to the tapered section of the suture needle.
- In one embodiment, the suture needle may be made of an elastic, hyper-elastic, or superelastic material or alloy such as Nitinol.
- In one embodiment, a system for aligning a needle driver with a tip of a suture needle may include a suture needle package having a base, a needle driver alignment guide overlying the base, and at least one connector for releasably securing the suture needle to the suture needle package.
- In one embodiment, the needle driver alignment guide preferably includes first and second lateral guide walls that oppose one another for defining a needle driver guide channel. In one embodiment, an end wall desirably interconnects the first and second lateral guide walls for defining a distal end of the needle driver alignment guide.
- In one embodiment, a suture needle desirably overlies the base. The suture needle may include a proximal end and a distal end having a tapered section that terminates at a tip.
- In one embodiment, the at least one connector preferably secures the suture needle over the base and controls the orientation of the suture needle so that the tip of the suture needle is located within the suture needle guide channel and is bounded by the end wall and the first and second lateral guide walls.
- In one embodiment, a needle driver may have an elongated shaft and a clamping assembly located at a distal end of the elongated shaft. In one embodiment, the clamping assembly engages the end wall of the needle driver alignment guide for aligning the clamping assembly with the tip of the suture needle.
- In one embodiment, the at least one connector desirably holds the tip of the suture needle between the first and second lateral guide walls so that the tip is spaced away from the first and second lateral guide walls.
- In one embodiment, the at least one connector may hold the tip of the suture needle proximal to and spaced away from the end wall of the needle driver alignment guide by a first distance.
- In one embodiment, a clamping assembly preferably has a lower jaw with a top surface and an opposing upper jaw with a bottom surface that is pivotally coupled with the lower jaw for moving the clamping assembly between open and closed positions. In one embodiment, a distal end of the lower jaw engages the end wall, whereupon the top surface of the lower jaw is aligned with the tip of the suture needle.
- In one embodiment, the top surface of the lower jaw preferably has a length that extends between a proximal end and the distal end thereof. In one embodiment, the length of the top surface of the lower jaw is desirably greater than the first distance between the tip of the suture needle, secured by a connector, and the end wall of the needle driver alignment guide.
- In one embodiment, when the clamping assembly is abutted against the end wall of the alignment guide, the upper jaw of the clamping assembly is desirably positioned over the tip of the suture needle and the lower jaw of the clamping assembly is desirably positioned under the tip of the suture needle.
- In one embodiment, the first and second lateral guide walls are spaced from one another to define a width of the needle driver alignment guide.
- In one embodiment, a resilient element, such as a foam pad or one or more springs, may be disposed between the first and second lateral guide walls for urging a needle driver against one of the first and second lateral guide walls.
- In one embodiment, the elongated shaft of the needle driver has a width that is substantially equal to the width of the needle driver alignment guide.
- In one embodiment, the elongated shaft of the needle driver has an outer diameter, and the needle driver alignment guide preferably has a depth that is about ½ the dimension of the outer diameter of the elongated shaft of the needle driver.
- In one embodiment, a method of delivering a suture needle to a surgical site desirably includes obtaining a suture needle package having a needle driver alignment channel, and a suture needle secured to the suture needle package, the suture needle having a distal end with a tapered section that terminates at a tip, whereby the tapered section and the tip of the suture needle are positioned within the needle driver alignment channel.
- In one embodiment, a method includes positioning a needle driver in the needle driver alignment channel, the needle driver having a clamping assembly at a distal end thereof that is moveable between open and closed positions.
- In one embodiment, with the clamping assembly of the needle driver in the open position, the clamping assembly is preferably advanced along a longitudinal axis of the needle driver alignment channel toward a distal end of the needle driver alignment channel for aligning the clamping assembly with the tip of the suture needle.
- In one embodiment, after the clamping assembly reaches the end of the needle driver alignment channel (e.g., tactile feedback of abutting against the end wall), the clamping assembly may be moved to the closed position for clamping the portion of the tapered section of the suture needle that is positioned within the needle driver alignment channel. In one embodiment, the closed clamping assembly preferably covers the tip for preventing exposure of the tip outside the clamping assembly.
- In one embodiment, the closed clamping assembly may be used for lifting the suture needle out of the suture needle package.
- In one embodiment, with the proximal end of the suture needle trailing the tip of the suture needle, the closed clamping assembly may be used for passing the suture needle through a trocar.
- In one embodiment, the suture needle is made of an elastic material such as a hyper-elastic material or a superelastic material (e.g., Nitinol).
- In one embodiment, the suture needle preferably has a more curved configuration (e.g., a half-circle shape or higher profile) when secured to the suture needle package and a less curved configuration (e.g. a flatter shape or lower profile) during passing the suture needle through the trocar.
- In one embodiment, the suture needle may be loaded onto the needle driver using one hand.
- In one embodiment, a system may include a suture needle package and a needle driver packaged together, whereby the needle driver is used for removing one or more suture needles or surgical needles from the package.
- In one embodiment, the suture needle is preferably releasably secured to the suture needle package, such as by using one or more friction fit or snap-fit connectors that engage the outer surface of the suture needle.
- In one embodiment, the needle driver may have elongated shafts having different outer diameters or widths of about 3-8 mm and more preferably about 5 mm.
- In one embodiment, the suture needle package, the suture needle, and the needle driver are preferably sterilizable, biocompatible, and stable.
- In one embodiment, a suture needle package preferably includes a needle driver guide channel that is configured to guide a needle driver into alignment with a distal tip of a suture needle that is releasably secured to the package.
- In one embodiment, the suture needle package preferably includes one or more connectors that releasably secure a suture needle to the package, wherein the one or more connectors form a snap-fit, a friction fit, and/or a releasable connection with the suture needle so that the suture needle may be easily released from the package when secured by the needle driver.
- In one embodiment, at least one of the connectors preferably orients the suture needle at a preferred angle relative to the needle driver and the needle driver guide channel.
- In one embodiment, a resilient element or spring may be disposed within the needle driver guide channel for urging an elongated shaft of a needle driver against an opposite guide wall of the needle driver guide channel. In one embodiment, if the needle driver guide channel has a width that is greater than the width or outer diameter of the elongated shaft of the needle driver, the resilient element or spring takes up the slack or space to engage the elongated shaft, which makes sure that different sized needle holders will align with the tip of the suture needle with the tip not protruding outside the clamping jaws of the needle driver.
- In one embodiment, the needle driver guide channel may include a hard stop or a tactile indicator that aids a surgeon to align the clamping assembly with the tip of the suture needle.
- In one embodiment, the needle driver alignment guide has a low profile so that is may be integrated into existing suture needle package designs.
- In one embodiment, the needle driver alignment guide may have an open window on top to access the needle tip in the suture needle package. In one embodiment, the needle driver alignment guide may have an opening on the side for accessing the tipoff the suture needle.
- The needle driver alignment guide preferably enables a needle holder to be consistently aligned with the tip of the suture needle, for clamping onto a tapered section of the needle that is proximal to the tip, without exposing the tip to possible damage during transfer through a trocar.
- In one embodiment, the angle of the needle relative to the long axis of the needle driver may be controlled to minimize the amount of force that is required to advance (e.g., push, pull) the suture needle force through a trocar.
- In one embodiment, after the needle driver is closed, the suture needle may be lifted from the suture package for direct introduction through the trocar.
- In one embodiment, direct loading of the suture needle from the suture package prevents accidental stabbing of surgical personnel.
- In one embodiment, obtaining access to the suture needle may be possible through either the top or the side of the suture needle package.
- In one embodiment, the needle driver guide channel may be made of paper, which may also be used to control moisture levels within a suture needle package.
- In one embodiment, the needle driver alignment guide is visible to a surgeon (e.g., visible on a top side of a suture needle package) to provide a simple, intuitive design for securing the tip of a suture needle with a needle driver or clamping element.
- In one embodiment, a needle driver alignment guide may be readily incorporated into an existing design for a suture needle package without requiring modification of the existing design.
- In one embodiment, the needle driver guide channel preferably controls the direction and the angle of the needle holder relative to the tip and the tapered section of the suture needle when loading the suture needle.
- In one embodiment, the inside geometry of the needle driver guide channel desirably matches the geometry of the needle holder.
- In one embodiment, the needle driver alignment guide preferably stops the introduction of the needle holder when the tip of the needle is aligned with the jaws of the clamping assembly.
- These and other preferred embodiments of the present invention will be described in more detail below.
-
FIG. 1A is a side view of a suture needle having a proximal end and a distal end with a tapered section and a distal tip, in accordance with one embodiment of the present patent application. -
FIG. 1B is a magnified view of the tapered section and the distal tip of the suture needle shown inFIG. 1A . -
FIG. 2A is a perspective view of a needle driver having an elongated shaft with a proximal end, a distal end, and a clamping assembly at the distal end of the elongated shaft, the clamping assembly including lower and upper jaws moveable between open and closed positions, in accordance with one embodiment of the present patent application. -
FIG. 2B is a perspective view of the distal end of the elongated shaft and the clamping assembly of the needle driver shown inFIG. 2A . -
FIG. 3 shows a suture needle package for a suture needle including a needle driver alignment guide, in accordance with one embodiment of the present patent application. -
FIG. 4 is a top plan view of a suture needle package having a needle driver alignment guide that guides a distal end of the needle driver into alignment with a tip of a suture needle, in accordance with one embodiment of the present patent application. -
FIG. 5A shows a tip of a suture needle aligned with the lower and upper jaws of the clamping assembly of the needle driver ofFIGS. 2A and 2B , in accordance with one embodiment of the present patent application. -
FIG. 5A-1 shows the suture needle and the needle driver ofFIG. 5A with the upper jaw of the clamping assembly removed. -
FIG. 5B shows a perspective end view of the needle driver ofFIG. 5A . -
FIG. 5C shows another perspective end view of the needle driver shown inFIG. 5A . -
FIG. 6 is a top plan view of a suture needle package for a suture needle, the suture needle package having a needle driver alignment guide, in accordance with one embodiment of the present patent application. -
FIG. 7 is a magnified view of the suture needle package and the needle driver alignment guide ofFIG. 6 . -
FIG. 8A shows the clamping assembly of the needle driver ofFIGS. 2A and 2B in a closed position for securing the tip of a suture needle, in accordance with one embodiment of the present patent application. -
FIG. 8B shows the needle driver ofFIG. 8A removing the suture needle from the suture needle package, in accordance with one embodiment of the present patent application. -
FIG. 9A shows a stage of a method of using a needle driver to advance an elastic suture needle toward a distal end of a trocar, in accordance with one embodiment of the present patent application. -
FIG. 9B shows the needle driver and the elastic suture needle ofFIG. 9A after the suture needle has been advanced beyond the distal end of the trocar for being located at a surgical site, in accordance with one embodiment of the present patent application. -
FIG. 9C shows a stage of a method of using a needle driver to retract an elastic suture needle from a surgical site and toward a proximal end of the trocar, in accordance with one embodiment of the present patent application. -
FIG. 9D shows a later stage of a method of retracting the elastic suture needle toward the proximal end of the trocar, in accordance with one embodiment of the present patent application. -
FIG. 10A is a perspective view of a suture needle package having a needle driver alignment guide, in accordance with one embodiment of the present patent application. -
FIG. 10B is a top plan view of the suture needle package shown inFIG. 10A . -
FIG. 10C is a perspective end view of the suture needle package shown inFIGS. 10A and 10B . -
FIG. 10D is another perspective view of the suture needle package shown inFIGS. 10A-10C . -
FIG. 11A is a perspective view of the suture needle package ofFIGS. 10A-10D and a suture needle secured to the suture needle package, in accordance with one embodiment of the present patent application. -
FIG. 11B is a top plan view of the suture needle package and the suture needle shown inFIG. 11A . -
FIG. 11C is a perspective end view of the suture needle package and the suture needle shown inFIGS. 11A and 11B . -
FIG. 11D is a magnified view of a distal end of the suture needle package and the suture needle shown inFIGS. 11A-11C . -
FIG. 12 is a perspective view of a base of a suture needle package, in accordance with one embodiment of the present patent application. -
FIG. 13A is a perspective view of a needle driver alignment guide for a suture needle package, in accordance with one embodiment of the present patent application. -
FIG. 13B is a top plan view of the needle driver alignment guide shown inFIG. 13A . -
FIG. 13C is a perspective end view of the needle driver alignment guide shown inFIGS. 13A and 13B . -
FIG. 14A shows the needle driver alignment guide ofFIGS. 13A-13C secured atop the base ofFIG. 12 , with a suture needle secured over the needle driver alignment guide, in accordance with one embodiment of the present patent application. -
FIG. 14B is a top plan view of the base, the needle driver alignment guide, and the suture needle shown inFIG. 14A . -
FIG. 14C is a magnified view of the needle driver alignment guide and the suture needle shown inFIGS. 14A and 14B . -
FIG. 14D is a top plan view of the needle driver alignment guide and the suture needle shown inFIG. 14C . -
FIG. 15A is a perspective end view of a base of a suture needle package, in accordance with one embodiment of the present patent application. -
FIG. 15B is another perspective end view of the base of the suture needle package shown inFIG. 15A . -
FIG. 16A is a perspective view of a needle driver alignment guide, in accordance with one embodiment of the present patent application. -
FIG. 16B is a top plan view of the needle driver alignment guide shown inFIG. 16A . -
FIG. 17A is a perspective view of the base ofFIGS. 15A-15B and the needle driver alignment guide ofFIGS. 16A-16B assembled with the base, in accordance with one embodiment of the present patent application. -
FIG. 17B shows a magnified view of a distal end of the base and the needle driver alignment guide shown inFIG. 17A . -
FIG. 18A is a top plan view of the distal end of the base and the needle driver alignment guide ofFIG. 17B with a tip of a suture needle aligned with the needle driver alignment guide, in accordance with one embodiment of the present patent application. -
FIG. 18B is a magnified view of the tip of the suture needle and the needle driver alignment guide ofFIG. 18A . -
FIG. 19A is a perspective view of a method of using a needle driver to remove a suture needle from a suture needle package, in accordance with one embodiment of the present patent application. -
FIG. 19B is a top plan view of the needle driver, the suture needle package and the suture needle shown inFIG. 19A . -
FIG. 19C is a perspective end view of the needle driver, the suture needle package and the suture needle shown inFIGS. 19A and 19B . -
FIG. 19D is another perspective end view of the needle driver, the suture needle package and the suture needle shown inFIGS. 19A-19C . -
FIG. 19E is an end view of needle driver, the suture needle package and the suture needle shown inFIGS. 19A-19D . -
FIG. 19F is a top plan view of the needle driver, the suture needle package and the suture needle shown inFIGS. 19A-19E with an upper jaw of a clamping assembly removed to show the tip of the suture needle alignment with a top surface of a lower jaw, in accordance with one embodiment of the present patent application. -
FIG. 20A shows a first stage of a method of aligning a distal end of a needle driver with a tip of a suture needle, in accordance with one embodiment of the present patent application. -
FIG. 20B shows a second stage of a method of aligning a distal end of a needle driver with a tip of a suture needle, in accordance with one embodiment of the present patent application. -
FIG. 21 shows a top plan view of a suture needle package having a needle driver alignment guide and a tip of a suture needle positioned within the needle driver alignment guide, in accordance with one embodiment of the present patent application. -
FIG. 22 shows a side view of a suture needle having a bendable region for bending the suture needle into a seagull shaped configuration, in accordance with one embodiment of the present patent application. -
FIG. 23 shows a side view of a suture needle having a bendable region for bending the suture needle into a seagull shaped configuration, in accordance with one embodiment of the present patent application. -
FIG. 24 shows a side view of a suture needle having a bendable region for folding the suture needle in half so that the tip is adjacent the proximal end of the suture needle, in accordance with one embodiment of the present patent application. -
FIG. 25 shows a side view of a suture needle having a bendable region for folding the suture needle in half do that the tip is adjacent the proximal end of the suture needle, in accordance with one embodiment of the present patent application. - Referring to
FIGS. 1A and 1B , in one embodiment, asuture needle 100 preferably includes anelongated body 102 having anouter surface 104 that extends from aproximal end 106 to adistal end 108 of the suture needle. In one embodiment, thesuture needle 100 is preferably made of an elastic, hyper-elastic, or superelastic material, such as Nitinol, whereby an external force may be applied to the suture needle to elastically deform the suture needle, and the suture needle will spring back to its original shape and/or configuration when the external force is removed. In one embodiment, theelongated body 102 of thesuture needle 100 is curved and may have a semi-circular or circular shaped segment. In one embodiment, the suture needle defines a half circle or semi-circle. In one embodiment, the suture needle defines ¼ of a circle, ⅜th of a circle, ⅝th of a circle, ¾ of a circle, etc. - In one embodiment, the
suture needle 100 preferably includes asuture attachment barrel 110 that is located at theproximal end 106 of theelongated body 102, which preferably has a suture attachment opening formed in a proximal face thereof. In one embodiment, a distal end of a surgical suture may be inserted into the suture attachment opening of thesuture attachment barrel 110 and the barrel may be swaged for securing the surgical suture to theproximal end 106 of thesuture needle 100. - In one embodiment, the
distal end 108 of thesuture needle 100 preferably includes a taperedsection 112 that tapers inwardly to atip 114 that is located at a distal-most end of the suture needle. Thetip 114 may be sharpened for piercing tissue to facilitate passing the suture needle through tissue during a suturing operation. - In one embodiment, the suture needle may have a bendable region or may be highly elastic for changing shape and/or configuration to fit through a trocar (e.g., a 5 mm trocar), as disclosed in commonly assigned U.S. patent application Ser. Nos. 16/282,604, filed on Feb. 22, 2019, published as US 2020/0268378 (Attorney Docket Number ETH6024USNP1), 16/282,652, filed on Feb. 22, 2019, published as US 2020/0268379 (Attorney Docket Number ETH6025USNP1), and Ser. No. 16/781,055, filed on Feb. 4, 2020, which claims benefit of U.S. Provisional Application No. 62/809,016, filed on Feb. 22, 2019, and now published as US 2020/0268380 (Attorney Docket Number ETH6026USNP1), the disclosures of which are hereby incorporated by reference herein.
- Referring to
FIGS. 2A and 2B , in one embodiment, a clamping element such as aneedle driver 116 may be utilized for securing a suture needle, such as thesuture needle 100 shown inFIGS. 1A and 1B , to remove the suture needle from a suture needle package and advance the clamped suture needle through a trocar to a surgical site for performing a suturing operation. In one embodiment, the shape of the suture needle may change as theneedle driver 116 advances the suture needle through the trocar. For example, the suture needle may be a superelastic suture needle that normally has a semi-circular shape with a first height. As the needle driver advances the suture needle through the trocar having a smaller inner diameter than the first height of the suture needle, the suture needle will flatten out or become straighter along at least one segment for assuming a smaller, second height for fitting through the smaller trocar. Upon being extracted from the end of the trocar, the superelastic suture needle will preferably return (e.g., spring back) to its original first height and the original semi-circular shape. - In one embodiment, the
needle driver 116 preferably includes anelongated shaft 118 having aproximal end 120 and adistal end 122 including a clampingassembly 124 that is movable between open and closed positions. In one embodiment, the clampingassembly 124 preferably includes alower jaw 126 and an opposingupper jaw 128 that is movable between open and closed positions. In one embodiment, with the clampingassembly 124 in the open position, the lower andupper jaws - Referring to
FIG. 2B , in one embodiment, thelower jaw 126 may be stationary and/or rigidly secured to thedistal end 122 of theelongated shaft 118 of theneedle driver 116 so that thelower jaw 126 is fixed and does not move relative to thedistal end 122 of theelongated shaft 118 of theneedle driver 116. In one embodiment, thelower jaw 126 preferably includes a substantially flattop surface 130 that is adapted to be aligned with the tip 114 (FIG. 1B ) that is located at the distal end of the suture needle. In one embodiment, the substantially flattop surface 130 of thelower jaw 126 may include a surface roughening such as knurling for enhancing gripping of the tapered section 112 (FIG. 1B ) of the suture needle when the clampingassembly 124 is in the closed position. - In one embodiment, the
upper jaw 128 of the clampingassembly 124 is desirably pivotally secured to thedistal end 122 of theelongated shaft 118 of theneedle driver 116 via apivot 132, which pivotally secures a proximal end of theupper jaw 128 to thedistal end 122 of theelongated shaft 118. Theupper jaw 128 preferably includes a substantially flatbottom surface 132 that opposes the substantially flattop surface 130 of thelower jaw 126. The substantially flatbottom surface 134 of theupper jaw 128 may include surface roughening such as knurling for gripping the tapered section 112 (FIG. 1B ) of a suture needle when the clampingassembly 124 is in the closed position. - In one embodiment, when the lower and
upper jaws top surface 130 of thelower jaw 126 and thebottom surface 134 of theupper jaw 128 preferably engage the tapered section of the suture needle that is located between the jaws, however, the top and bottom surfaces of the jaws are spaced away from the tip so that the tip is not marred or dulled by the jaws of the clamping assembly. - Referring to
FIGS. 3 and 4 , in one embodiment, asuture needle package 136 preferably holds asuture needle 100, such as the suture needle shown inFIGS. 1A and 1B , so that thetip 114 of thesuture needle 100 is pre-positioned at a location that will facilitate aligning thetip 114 of thesuture needle 100 between the top andbottom surfaces lower jaws assembly 124 of theneedle driver 116. - In one embodiment, the
suture needle package 136 preferably includes a needledriver alignment guide 138 having a firstlateral guide wall 140 and an opposing secondlateral guide wall 142 that preferably engage the lateral sides of theelongated shaft 118 of the needle driver 116 (FIG. 2A ) for guiding the clamping assembly of the needle driver in the direction designated DIR1 for aligning the lower and upper jaws of the clampingassembly 124 with thetip 114 of thesuture needle 100 to ensure that thetip 114 is positioned between the top and bottom surfaces of the respective upper and lower jaws of the clamping assembly. In one embodiment, the first and secondlateral guide walls driver guide channel 143, which preferably aligns the needle driver with thetip 114 as the needle driver moves in the direction DIR1 toward thetip 114. - Referring to
FIG. 4 , in one embodiment, thesuture needle package 136 preferably includes one or more releasable connectors that releasably secure the suture needle to the suture needle package. In one embodiment, the one or more releasable connectors desirably hold thetip 114 of thesuture needle 100 at a known location having three dimensions, between the firstlateral guide wall 140 and the opposing secondlateral guide wall 142 so that jaws of the clampingassembly 124 may be consistently aligned with thetip 114 as theneedle driver 116 is advanced in the direction designated DIR1 through the needledriver guide channel 143 defined by the needledriver alignment guide 138. In one embodiment, theneedle driver 116 preferably includes theelongated shaft 116 having an outer diameter OD1 that closely matches the width W1 of the needledriver alignment guide 138, which is preferably defined as the distance between the firstlateral guide wall 140 and the opposing secondlateral guide wall 142. In one embodiment, if the outer diameter of the elongated shaft of the needle driver is less than the width of the needle driver alignment guide, a resilient element (e.g., a foam strip, a spring) may be inserted into the needle driver alignment guide for engaging the side of the elongated shaft for urging the shaft against one of the first and second lateral guide walls. The needle driver alignment guide preferably has a depth that is about equal to ½ the diameter of theelongated shaft 118 of theneedle driver 116 so that the space between the opposing lower and upper jaws is aligned with thetip 114 of the suture needle. - In one embodiment, as the
elongated shaft 118 of theneedle driver 116 is advanced through the needledriver alignment guide 138 in a direction designated DIR1, the clampingassembly 124 will preferably advance distally until a distal-most end of thelower jaw 126 abuts against ahard stop 144 that is located at a distal end of the needledriver alignment guide 138. In one embodiment, when the distal-most end of thelower jaw 126 abuts against thehard stop 144, the flattop surface 130 of thelower jaw 126 is preferably aligned with thetip 114 of thesuture needle 100. With the suture needle package holding the tip of the suture needle at a known location having X, Y and Z coordinates, the needle driver alignment guide preferably controls the position of the lower and upper jaws along respective X, Y and Z axes to ensure that the tip is consistently and repeatedly positioned between the opposing clamping faces of the lower and upper jaws. In one embodiment, thetop surface 130 of thelower clamping jaw 126 has a length L1 that is greater than the distance L2 between thetip 114 and the proximal face of thehard stop 144, which ensures that thetip 114 will be located between the proximal anddistal ends top surface 130 of thelower jaw 126. As a result, thetip 114 will generally be aligned midway between the proximal anddistal ends top surface 130 of thelower jaw 126. In one embodiment, similar dimensions are provided for the bottom surface of the upper jaw to insure that the tip is positioned approximately midway between the proximal and distal ends of the upper jaw of the clamping assembly. - As will be described in more detail herein, the upper jaw of the clamping assembly 124 (
FIG. 2B ) may be moved to the closed position for engaging the taperedsection 112 of thesuture needle 100 to secure thetip 114 of thesuture needle 100 between the lower and upper jaws of theneedle driver 116. In one embodiment, the clamping faces of the lower and upper jaws do not contact the tip, but rather clamp onto the thicker, tapered section of the suture needle to avoid damaging or dulling the tip. - Referring to
FIGS. 5A and 5A-1 , in one embodiment, theneedle driver 116 preferably includes theelongated shaft 118 having a longitudinal axis A1 that extends between the proximal and distal ends of theelongated shaft 118. In one embodiment, as a result of the suture needle being held on the suture needle package in a pre-determined orientation, when thetip 114 of thesuture needle 100 is secured between the lower andupper jaws section 112 of thesuture needle 100 preferably extends along an axis A1′ that defines an angle α1 that is less than 90 degrees relative to the longitudinal axis A1 of theelongated shaft 118 of theneedle driver 116. Holding thesuture needle 100 at an angle that is less than 90 degrees preferably minimizes the amount of force that is required when using the needle driver to push or pull the suture needle though a trocar. - Referring to
FIGS. 5B and 5C , in one embodiment, the needle driver alignment guide 138 (FIGS. 3 and 4 ) preferably aligns the clampingassembly 124 of theneedle driver 116 with thetip 114 of thesuture needle 100 along the X, Y, and Z axes. In one embodiment, after using the needle driver alignment guide for aligning the clamping assembly with the suture needle, thetip 114 is preferably disposed between thetop surface 130 of thelower jaw 126 and thebottom surface 134 of theupper jaw 128 of the clampingassembly 124. Theelongated body 102 of thesuture needle 100 preferably extends proximally toward the proximal end of theelongated shaft 118 of theneedle driver 116. - In one embodiment, the engagement of the needle driver with the needle driver alignment guide insures that the
tip 114 of thesuture needle 100 is preferably aligned between the top andbottom surfaces upper jaws tip 114 is not exposed and/or does not extend beyond or outside thelateral sides upper jaws tip 114 of thesuture needle 100 between the lower and upper jaws so that thetip 114 it is not exposed outside the jaws of the clampingassembly 124 will desirably protect thetip 114 as theneedle driver 116 advances thesuture needle 100 through a trocar. As a result, the protected tip will not be exposed and will not scratch the inside of the trocar, which could weaken, dull and/or damage the tip. - Referring to
FIG. 5C , in one embodiment, the taperedsection 112 of thesuture needle 100 tapers inwardly toward thetip 114 that is located at the distal end of thesuture needle 100. As a result, the taperedsection 112 of the suture needle becomes thinner toward thetip 114. In one embodiment, when the clampingassembly 124 is closed, the opposing top and bottom surfaces of the respective lower andupper jaws section 112 of the suture needle so that thetip 114 is not engaged by the opposing faces of the lower and upper jaws. Thus, in one embodiment, the clamping jaws provide a protective shroud or barrier around the tip of the suture needle, however, the clamping surfaces of the lower and upper jaws do not directly contact or engage the tip of the suture needle. - Referring to
FIGS. 6 and 7 , in one embodiment, asuture needle package 236 preferably includes a base 250 having atop surface 252 that is adapted to secure asuture needle 200 over thetop surface 252. In one embodiment, thesuture needle package 236 preferably has aproximal end 254, adistal end 256, and a longitudinal axis A2 that desirably extends from theproximal end 254 to thedistal end 256 of the package. In one embodiment, thesuture needle package 236 desirably includes a needledriver alignment guide 238 that preferably extends along the longitudinal axis A2 of the base of thesuture needle package 236. In one embodiment, the needle driver alignment guide desirably includes a firstlateral guide wall 240, a secondlateral guide wall 242 that opposes the firstlateral guide wall 240, and anend wall 244 that preferably functions at a hard stop for halting distal movement of a needle driver through the needledriver alignment guide 238. The first and second lateral guide walls and the end wall preferably define the boundaries of a needledriver guide channel 243 provided on the suture needle package. In one embodiment, the needledriver alignment guide 238 defines a width W2 that extends laterally between opposing inner surfaces of the firstlateral guide wall 240 and the secondlateral guide wall 242. The width W2 preferably equals the distance between inner surfaces of the first and secondlateral guide walls - In one embodiment, the
suture needle 200 is secured over a top of thesuture needle package 236 so that thetip 214 at a distal-most end of thesuture needle 200 is positioned between the firstlateral guide wall 240, the secondlateral guide wall 242, and theend wall 244 that functions as a hard stop. In one embodiment, when thesuture needle 200 is secured to thesuture needle package 236, a gap G is present between thetip 214 and the inner surface of the secondlateral guide wall 242. In one embodiment, thetip 214 is preferably spaced away from the inner surface 245 (FIG. 7 ) of the secondlateral guide wall 242 by a distance that is preferably less than ½ the distance defined by the width W2 of the needle driver alignment guide. Thetip 214 is spaced proximally from theend wall 244 by a distance L3 - Referring to
FIG. 7 , in one embodiment, thesuture needle package 236 preferably includes aproximal connector 260 that releasably secures a proximal section of thesuture needle 100 over thetop surface 252 of the suture needle package, and adistal connector 262 that preferably secures a distal section of thesuture needle 200 over thetop surface 252 of thesuture needle package 236. The proximal anddistal connectors elongated body 202 of thesuture needle 200 so that thesuture needle 200 may be selectively detached and removed from thesuture needle package 236. The proximal anddistal connectors suture needle 100 in place within the package and prevent the suture needle from shifting or being loose during initial packaging, shipment, and storage of the suture needle. - The needle
driver alignment guide 238 preferably includes theend wall 244 that interconnects distal ends of the respective first and secondlateral guide walls end wall 244 preferably functions as a hard stop for abutting against a distal-most end of the needle driver as the needle driver is advanced through the needledriver alignment guide 238 in the direction DIR1. In one embodiment, as theneedle driver 116 is advanced through the needledriver alignment guide 238 in the direction DIR1, when a distal end of the lower jaw of the needle driver abuts against theend wall 244, the top surface of the lower jaw is preferably aligned with thetip 214 of thesuture needle 200 and the bottom surface of the upper jaw is also preferably aligned with and overlies the tip of the suture needle. The sutureneedle guide channel 238 preferably has depth that aligns the lower jaw below thetip 214 and the upper jaw above the tip. - In one embodiment, the
suture needle package 236 may include a resilient element 264 (e.g., a foam strip, one or more springs) that desirably abuts against a side of the elongated shaft of the needle driver 116 (FIG. 2A ) for pressing the elongated shaft against theinner surface 243 of the secondlateral guide wall 242, which insures that the opposing top and bottom surfaces of the respective lower and upper jaws of the clamping assembly remain aligned with thetip 214 of thesuture needle 200. In one embodiment, theresilient element 264 may be a strip of foam that is adapted to press against a lateral side of the elongated shaft of the needle driver for urging the elongated shaft and the clamping assembly to abut against the secondlateral guide wall 242. In one embodiment, theresilient element 264 may include one or more springs that press against a lateral side of the elongated shaft of the needle driver. - Referring to
FIG. 8A , in one embodiment, theelongated shaft 218 of theneedle driver 216 is preferably advanced through the needledriver alignment guide 238 in the direction DIR1 for engaging the tip 214 (FIG. 7 ) located at the distal-most end of thesuture needle 200. Theresilient element 264 positioned between the first and secondlateral guide walls driver alignment guide 238 desirably urges theelongated shaft 218 against theinner surface 243 of the secondlateral guide wall 242 so that the clampingassembly 224 is aligned with the tip 214 (FIG. 7 ) at the distal-most end of thesuture needle 200. When the tip of the suture needle is positioned between thelower jaw 226 and theupper jaw 228 of the clampingassembly 224, the clampingassembly 224 may be closed for pinching the taperedsection 212 of thesuture needle 200 between the opposing top and bottom surfaces of the respective lower andupper jaws - Referring to
FIG. 8B , in one embodiment, after the clampingassembly 224 of theneedle driver 216 has been closed for engaging the taperedsection 212 of thesuture needle 200 between thelower jaw 226 and theupper jaw 228, the tip 214 (FIG. 7 ) of the suture needle is preferably surrounded by the lower and upper jaws of the clamping assembly so that the tip is not exposed outside the perimeter of the lower and upper jaws. The clampedsuture needle 200 may be lifted away from thetop surface 252 of thesuture needle package 236 for uncoupling theelongated body 202 from the proximal anddistal connectors 260, 262 (FIG. 7 ) provided on thetop surface 252 of thesuture needle package 236. - Referring to
FIG. 9A , in one embodiment, after the clampingassembly 224 of theneedle driver 216 has been closed for clamping onto the tapered section of thesuture needle 200, theneedle driver 216 may be utilized for advancing thesuture needle 200 through a trocar for positioning the suture needle at a surgical site for performing a suturing operation. In one embodiment, atrocar 266 preferably has anelongated conduit 268 defining an inner diameter that extends to an opening at adistal end 270 of the trocar. The clampingassembly 224 of theneedle driver 216 is preferably advanced through theconduit 268 of thetrocar 266 for pulling theneedle 200 through the trocar. As thesuture needle 200 is pulled by the clampingassembly 224 toward thedistal end 270 of thetrocar 266, theelongated body 202 of thesuperelastic suture needle 200 preferably elastically deforms (e.g., straightens out, becomes flatter) as shown inFIG. 9A . - Referring to
FIG. 9B , after the clampedsuture needle 200 has been advanced beyond thedistal end 270 of thetrocar 266, theelastic suture needle 200 preferably returns to the original curved configuration (e.g., a half circle shape). Surgical personnel may then utilize thecurved suture needle 200 for performing a suturing operation at the surgical site. - Referring to
FIG. 9C , in one embodiment, at the conclusion of a suturing operation, thesuture needle 200 may be removed from a patient by retracting the suture needle through thetrocar 260. In one embodiment, the clampingassembly 224 is again closed for securing the tip of thecurved suture needle 200 between thelower jaw 226 and theupper jaw 228 of theneedle driver 216. - Referring to
FIG. 9D , in one embodiment, thesuture needle 200 is retracted through thecannula 268 of thetrocar 266. Thesuperelastic suture needle 200 preferably straightens out as it is retracted through the trocar by the clampingassembly 224 of theneedle driver 216. As the superelastic suture needle is withdrawn through thetrocar 266, the lower andupper jaws suture needle 200 and surround the tip. - Referring to
FIGS. 10A-10D , in one embodiment, asuture needle package 336 adapted to hold at least one suture needle preferably has aproximal end 354, adistal end 356 and a longitudinal axis A3 that extends along the length of thesuture needle package 336 between theproximal end 354 and thedistal end 356. In one embodiment, thesuture needle package 336 preferably includes a needledriver alignment guide 338 that extends along the longitudinal axis A3 of thesuture needle package 336. In one embodiment, the needledriver alignment guide 338 preferably includes a firstlateral guide wall 340 and an opposing secondlateral guide wall 342 that desirably define a needledriver guide channel 343 for guiding advancement of a needle driver toward the distal end 352 of thesuture needle package 336. In one embodiment, the needledriver alignment guide 338 preferably includes anend wall 344 that functions as a hard stop for halting distal movement of the jaws of a needle driver through the needle driver alignment channel. In one embodiment, thesuture needle package 336 preferably includes aproximal connector 360 that is adapted to form a releasable connection with a proximal end of a suture needle, and alateral connector 362 that is adapted to form a releasable connection with a more distal section of the suture needle. Thesuture needle package 336 also preferably includes a securingnotch 365 formed at an upper end of the firstlateral guide wall 340 that is adapted to form a releasable connection with a tapered section of a suture needle. In one embodiment, the securingnotch 365 is preferably spaced a distance L4 from theend wall 344 of the needledriver alignment guide 338. - Referring to
FIGS. 11A-11D , in one embodiment, asuture needle 300 may be secured to thesuture needle package 336 so that thetip 314 of thesuture needle 300 is positioned between the first and secondlateral guide walls end wall 344 of the needledriver alignment guide 338. In one embodiment, thetip 314 of thesuture needle 300 is spaced away from theinner face 343 of the secondlateral guide wall 342 so that a gap G is present between thetip 314 and the secondlateral guide wall 342. In addition, thetip 314 is preferably held proximal to theend wall 344 by a distance L4. In one embodiment, the distance L4 is preferably less than the length of the top surface of the lower jaw of the needle driver, and is more preferably equal to about one half of the length of the top surface of the lower jaw of the clamping assembly, which insures alignment of the top surface of the lower jaw with the tip of the suture needle. - In one embodiment, the
proximal end 306 of thesuture needle 300 is releasably secured to theproximal connecter 360 of thesuture needle package 336. In one embodiment, a mid-section of thesuture needle 300 is releasably secured to thelateral connector 362 of thesuture needle package 336. In one embodiment, the taperedsection 312 of thesuture needle 300 is releasably secured to the securingnotch 365 provided at the upper end of the firstlateral guide wall 340 of the needledriver alignment guide 338. The securingnotch 365 desirably holds thetip 314 of thesuture needle 300 at a known location having X, Y, and Z coordinates. - Referring to
FIG. 12 , in one embodiment, asuture needle package 436 preferably includes a base 452 having aproximal end 454, adistal end 456, and a longitudinal axis A4 that extends from theproximal end 454 to thedistal end 456 of thebase 452. In one embodiment, thebase 452 has atop surface 470 that is adapted to seat a needle driver alignment guide that holds a suture needle. - Referring to
FIGS. 13A-13C , in one embodiment, asuture needle platform 472 preferably has atop surface 474 that extends from aproximal end 476 to adistal end 478 of thesuture needle platform 472. In one embodiment, thesuture needle platform 472 preferably includes acurved groove 480 that is adapted to receive and/or releasably secure a suture needle over thetop surface 474 of thesuture needle platform 472. In one embodiment, thecurved groove 480 preferably has aproximal end 482 that is adapted to receive a proximal end of a curved suture needle and adistal end 484 that is adapted to receive a distal section of the curved suture needle. In one embodiment, thecurved groove 480 preferably includes aresilient element 486 that is desirably adapted to engage the elongated body of a suture needle for releasably securing a curved suture needle within thecurved groove 480 of thesuture needle platform 472. - In one embodiment, the
suture needle platform 472 preferably includes a needledriver alignment guide 438 that is formed in thetop surface 474 of thesuture needle platform 472. The needledriver alignment guide 438 preferably has a firstlateral guide wall 440, an opposing secondlateral guide wall 442, and anend wall 444 that functions as a hard stop at a distal-most end of the needle driver alignment guide. - Referring to
FIGS. 13B and 13C , in one embodiment, the needledriver alignment guide 438 preferably has aproximal end 488 that is located closer to theproximal end 476 of thesuture needle platform 472 and adistal end 490 that is located at theend wall 444 of the needledriver alignment guide 438. The needledriver alignment guide 438 preferably includes afloor 492 that may slope downwardly from thetop surface 474 toward theend wall 444. The needledriver alignment guide 438 preferably extends along a longitudinal axis A5. - Referring to
FIGS. 14A-14D , in one embodiment, thesuture needle platform 472 is preferably assembled over thetop surface 470 of thebase 452 of thesuture needle package 436. The longitudinal axis A5 of the needledriver alignment guide 438 is preferably co-axial with and extends along the longitudinal axis A4 of thebase 452 of thesuture needle package 436. Asuture needle 400 is preferably secured within thecurved groove 480 provided in thetop surface 474 of thesuture needle platform 472. Thecurved groove 480 preferably holds thetip 414 of thesuture needle 400 within the needledriver alignment guide 438 so that thetip 414 is preferably spaced away from the secondlateral guide wall 442 of the needledriver alignment guide 438, whereby a gap G is present between thetip 414 and the inner surface of the secondlateral guide wall 442. In one embodiment, thetip 114 is desirably spaced proximally from theend wall 444 of the needledriver alignment guide 438 by a distance L5. - In one embodiment, a distal end of the needle driver 116 (
FIG. 2A ) may be advanced from theproximal end 488 to thedistal end 490 of the needledriver alignment guide 438 until a distal-most end of the clamping assembly abuts against theend wall 444 of the needledriver alignment guide 438. At this stage, the opposing top and bottom surfaces of the respective lower and upper jaws of the clamping assembly are preferably aligned with thetip 414 of thesuture needle 400. The lower and upper jaws of the clamping assembly may be moved to the closed position for engaging (e.g., clamping) the taperedsection 412 of thesuture needle 400. The needle driver may be used to remove the clampedsuture needle 400 from theresilient connection 486 of thesuture needle platform 472, whereupon thesuture needle 400 may be extracted from thecurved groove 480 formed in thetop surface 474 of thesuture needle platform 472. The needle driver may be utilized for advancing (e.g., pulling) the clampedsuture needle 400 through a trocar to deliver the suture needle at a surgical site for performing a suturing operation. - Referring to
FIGS. 15A and 15B , in one embodiment, asuture needle package 536 preferably includes a base 552 having aproximal end 554, adistal end 556 and a longitudinal axis A6 that extends from theproximal end 554 to thedistal end 556. The base 552 may include aproximal gap 575 formed therein at theproximal end 554 of thebase 552, which is adapted to receive a needle driver alignment guide, as will be described in more detail below. - Referring to
FIGS. 16A and 16B , a needledriver alignment guide 538 preferably has a firstlateral guide wall 540 and an opposing secondlateral guide wall 542 that extend from aproximal end 588 to adistal end 590 of the needle driver alignment guide. The needledriver alignment guide 538 preferably has a longitudinal axis A7 that extends from theproximal end 588 to thedistal end 590 of the needle driver alignment guide. The needledriver alignment guide 538 preferably includes anend wall 588 that extends between distal ends of the respective first and secondlateral guide walls end wall 588 desirably functions as a hard stop for aligning the clamping jaws of a needle driver with a tip of a suture needle. The first and secondlateral guide walls proximal end 588 to thedistal end 590 of the needledriver alignment guide 538 so that the jaws may be properly aligned with a tip of a suture needle, as will be described in more detail herein. - Referring to
FIGS. 17A and 17B , in one embodiment, the needledriver alignment guide 538 is preferably assembled with the base 552 by inserting the needle driver alignment guide into thegap 575 located at thedistal end 556 of thebase 552 of thesuture needle package 536. The longitudinal axis A7 of the needledriver alignment guide 538 preferably extends along the longitudinal axis A6 of thebase 552. - Referring to
FIGS. 18A and 18B , in one embodiment, asuture needle 500 may be secured over thebase 552 of thesuture needle package 536 so that thetip 514 at the distal-most end of thesuture needle 500 is located between the first and secondlateral guide walls end wall 544 of the needledriver alignment guide 538. - Referring to
FIG. 18B , in one embodiment, thetip 514 is secured to thesuture needle package 536 so that thetip 514 of thesuture needle 500 is spaced away from theinner surface 543 of the secondlateral guide wall 542. In addition, thetip 514 of thesuture needle 500 is preferably located proximal to theend wall 544 of the needledriver alignment guide 538 so that a gap exists between theend wall 544 and thetip 514 of thesuture needle 500. - Referring to
FIGS. 19A-19F , in one embodiment, theneedle driver 116 having the clampingassembly 124 located at thedistal end 122 of theelongated shaft 118 may be utilized for removing thesuture needle 500 from thesuture needle package 536. - Referring to
FIG. 19B , in one embodiment, theelongated shaft 118 of theneedle driver 116 has an outer diameter OD1 that substantially matches the width W4 of the guide channel that extends between the firstlateral guide wall 540 and the secondlateral guide wall 542 of the needledriver alignment guide 538. In one embodiment, theneedle driver 116 is preferably advanced between the first and secondlateral guide walls assembly 124 abuts against theend wall 544 of the needledriver alignment guide 538. - Referring to
FIGS. 19C-19F , in one embodiment, when thelower jaw 526 of the clampingassembly 524 of theneedle driver 516 has abutted against theend wall 544 of the needledriver alignment guide 538, the top andbottom surfaces upper jaws tip 514 of thesuture needle 500. The top andbottom surfaces jaws tip 514 of the suture needle and theend wall 544 of the needledriver alignment guide 538 so that thetip 514 of the suture needle is located between the proximal and distal ends of the clamping surfaces and inside the lateral boundaries of the lower and upper jaws. As shown inFIG. 19F , thetip 514 of thesuture needle 500 is positioned inside thelateral wall 527 of thelower jaw 526 and is spaced proximally from theend wall 544 so that thetip 514 of thesuture needle 500 is not exposed and does not extend outside the perimeter of the lower and upper jaws of the clampingassembly 524. As a result, thetip 514 is protected and surrounded by the lower and upper jaws as the needle driver pulls thesuture needle 500 through a trocar for positioning the suture needle at a surgical site. - Referring to
FIG. 20A , in one embodiment, the needledriver alignment guide 538 has a firstlateral guide wall 540 having alower end 545 and anupper end 555 that define a depth D1 of the needle driver alignment guide. Theupper end 555 of the firstlateral guide wall 540 has a securingnotch 565 formed therein for securing a tapered section of the suture needle so that the tip 514 (FIG. 19F ) of the suture needle is located in the needle driver guide channel of the needledriver alignment guide 538. The securingnotch 565 spaces thetip 514 of the suture needle proximal to theend wall 544 of the needle driver alignment guide by a distance L6. - Referring to
FIGS. 20A and 20B , in one embodiment, the distal end of theneedle driver 516 may be advanced distally in the direction DIR1 until the distal end of thelower jaw 526 of the clampingassembly 524 engages the end wall 544 (FIG. 20B ), which preferably provides tactile feedback to a surgeon that the clamping assembly has reached the end of the needle driver guide channel and is aligned with thetip 514 of the suture needle. - Referring to
FIG. 20B , when the distal end of thelower jaw 526 engages theend wall 544 of the needledriver guide channel 538, thetop surface 530 of thelower jaw 526 is preferably aligned with thetip 514 of the suture needle. Thetop surface 530 of thelower jaw 526 preferably has a length L7 that is greater than the distance L6 between thetip 514 of the suture needle and theend wall 544 of the needledriver alignment guide 538 so that the tip is positioned between the proximal and distal ends of thetop surface 530 of thelower jaw 526. Thebottom surface 534 of theupper jaw 528 preferably has a similar length as the top surface of the lower jaw. In one embodiment, the securingnotch 565 holds thetip 514 at a known height that is between thelower end 545 and theupper end 555 of the firstlateral guide wall 540 so that thetop surface 530 of thelower jaw 526 is positioned under thetip 514 of the suture needle and thebottom surface 534 of theupper jaw 528 is positioned over thetip 514 of the suture needle. The suture needle package may be designed so that the tip of the suture needle is held at a predetermined location having known X, Y, and Z coordinates. The needle driver alignment guide and the needle driver may be designed to have dimensions to insure that the clamping surfaces of the needle driver jaw may be consistently and repeatedly aligned with the tip to ensure that the tip is protected and surrounded by the clamping assembly as the suture needle is passed through a trocar. - Referring to
FIG. 21 , in one embodiment, asuture needle package 636 preferably includes a needledriver alignment guide 638 that extends along a longitudinal axis A8. The needledriver alignment guide 638 preferably includes a firstlateral guide wall 640, an opposing secondlateral guide wall 642, and anend wall 644 that interconnects distal ends of the first and secondlateral guide wall lateral guide wall end wall 644 preferably define a needledriver guide channel 643 that is configured to guide a needle driver so that the clamping jaws of the needle driver are aligned with thetip 614 of thesuture needle 600. - In one embodiment, the
suture needle package 636 preferably includes areleasable connector 665 that secures a taperedsection 612 of thesuture needle 600 to the suture package so that thetip 614 is located within the elongated channel of the needledriver alignment guide 638. Theconnector 665 preferably holds thesuture needle 600 at a preferred orientation relative to the longitudinal axis A8 so that the taperedsection 612 of the suture needle extends along an axis A9 that defines an angle α2 of less than 90 degrees relative to the axis A8, which will require less force for passing the suture needle through a trocar. In one embodiment, the jaws of a needle driver may be inserted into the slot at theproximal end 688 of the needledriver alignment guide 638 and advanced in the direction DIR1 toward theend wall 644 at the distal end of the needledriver alignment guide 638. Once at least one of the jaws (e.g., the lower jaw) abuts against theend wall 644, the opposing top and bottom surfaces of the respective lower and upper jaws are preferably aligned with thetip 614 of thesuture needle 600. The jaws may be closed for clamping the tapered section and thetip 614 between the opposing jaws. Once the clamping assembly has been closed for clamping onto the taperedsection 612 of thesuture needle 600, the needle driver may be lifted away from thesuture package 636 to remove the suture needle from the suture package. - In one embodiment, the systems, suture packages, devices and methods disclosed herein may be used for passing suture needles having bendable or foldable regions through smaller trocars, whereby the suture needles are bent or folded to reduce their outer dimensions, heights, and/or profiles for being passed through trocars (e.g., a 5 mm trocar), as disclosed in commonly assigned U.S. Patent Application Ser. No. 16/282,604, filed on Feb. 22, 2019, published as US 2020/0268378 (Attorney Docket Number ETH6024USNP1), 16/282,652, filed on Feb. 22, 2019, published as US 2020/0268379 (Attorney Docket Number ETH6025USNP1), and Ser. No. 16/781,055, filed on Feb. 4, 2020, which claims benefit of U.S. Provisional Application No. 62/809,016, filed on Feb. 22, 2019, and now published as US 2020/0268380 (Attorney Docket Number ETH6026USNP1), the disclosures of which are hereby incorporated by reference herein. Referring to
FIGS. 22 and 23 , in one or more embodiments, suture needles 700, 800 have bendable regions that enable the needles to be bent into seagull shaped configurations for being passed through smaller trocars. Referring toFIGS. 24 and 25 , in one embodiment, suture needles 900, 1000 have bendable regions that enable the needles to be folded in half so that the tips of the needles are adjacent the proximal ends of the needles for being passed through smaller trocars. After being passed through trocars using the suture needle packages, needle driver guide channels, and needle drivers disclosed herein, the suture needles may be bent into a curved configuration (e.g., a half circle) for use in a suturing operation. At the conclusion of the suturing operation, the suture needles may be bent back into the configurations shown inFIGS. 22-25 for withdrawing the suture needles from the trocars. - While the foregoing is directed to embodiments of the present invention, other and further embodiments of the invention may be devised without departing from the basic scope thereof, which is only limited by the scope of the claims that follow. For example, the present invention contemplates that any of the features shown in any of the embodiments described herein, or incorporated by reference herein, may be incorporated with any of the features shown in any of the other embodiments described herein, or incorporated by reference herein, and still fall within the scope of the present invention.
Claims (21)
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US17/545,170 US20220104810A1 (en) | 2019-02-22 | 2021-12-08 | Suture needle packages for loading suture needles and methods of passing suture needles through trocars |
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US16/282,901 US11219449B2 (en) | 2019-02-22 | 2019-02-22 | Suture needle packages for loading suture needles and methods of passing suture needles through trocars |
US17/545,170 US20220104810A1 (en) | 2019-02-22 | 2021-12-08 | Suture needle packages for loading suture needles and methods of passing suture needles through trocars |
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US17/545,170 Pending US20220104810A1 (en) | 2019-02-22 | 2021-12-08 | Suture needle packages for loading suture needles and methods of passing suture needles through trocars |
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Also Published As
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CN113543725A (en) | 2021-10-22 |
US20200268383A1 (en) | 2020-08-27 |
US11219449B2 (en) | 2022-01-11 |
WO2020170153A1 (en) | 2020-08-27 |
CN113543725B (en) | 2024-06-07 |
EP3927244A1 (en) | 2021-12-29 |
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