CN107427296B

CN107427296B - Tissue anchors and percutaneous tricuspid valve repair using tissue anchors

Info

Publication number: CN107427296B
Application number: CN201580077789.3A
Authority: CN
Inventors: S·卡哈兰; J·罗宾逊; M·豪斯
Original assignee: Beijing Caditai Medical Device Technology Co Ltd
Current assignee: Beijing Caditai Medical Device Technology Co Ltd
Priority date: 2015-03-18
Filing date: 2015-03-18
Publication date: 2021-12-28
Anticipated expiration: 2035-03-18
Also published as: CA2979817A1; CN107427296A; CA2979817C; WO2016148714A1; EP3270794A1

Abstract

The present teachings provide devices and methods for treating tricuspid regurgitation. Specifically, one aspect of the present teachings provides devices and methods of identifying a suitable location on a tricuspid annulus, the positioning wire traversing the positioning wire across the tricuspid annulus at the identified suitable location, traversing and deploying one tissue anchor at the thus identified suitable location, deploying two or more tissue anchors, and coupling the tissue anchor with a flexible tensioning member and applying tension to the flexible tensioning member to which the two or more tissue anchors are coupled, folding the tissue between each pair of two or more tissue anchors, and reducing the circumference of the tricuspid annulus. As a result, backflow injection is reduced or eliminated.

Description

Tissue anchors and percutaneous tricuspid valve repair using tissue anchors

Technical Field

The present teachings relate generally to new tissue anchors and their use in percutaneous valve repair.

Background

Tricuspid valve disease involves symptoms of abnormal valve function between the two right heart chambers (i.e., the right ventricle and right atrium), and these diseases often occur with other heart valve problems. Examples of tricuspid valve disease include tricuspid regurgitation, tricuspid stenosis, tricuspid atresia and erbestan's abnormality. In tricuspid regurgitation, the tricuspid valve closes improperly and blood regurgitates back into the right atrium; in tricuspid stenosis, the tricuspid valve narrows and reduces the amount of blood flowing into the right ventricle; in tricuspid valve closure, congenital heart disease, a solid wall of tissue prevents blood flow between the two right heart chambers; in the Ebesartan anomaly, the malformed tricuspid valve is located at a position lower than its normal position within the right ventricle, causing a regurgitation of blood into the right atrium. Other diseases of the tricuspid valve, which are generally known to those of ordinary skill in the art, are also included in the present teachings.

Tricuspid valve disease can be corrected by an annuloplasty ring. In some cases, the device is preferably used for surgical repair of a defective tricuspid valve. Annuloplasty rings are anatomically compliant, corrective three-dimensional (3D) rings and can flexibly conform to the heart valve annulus. The ring is implanted into the defective tricuspid valve and the valve opening is reduced. After proper implantation, the annuloplasty ring allows the valve to open and close properly.

Tricuspid valve repair surgery can be performed in one of two ways: minimally invasive surgery or open heart surgery. Minimally invasive methods involve making a small incision in the upper or lower chest and inserting the valve repair system/device percutaneously. After valve repair, the incision is closed with a lytic suture positioning wire. Advantages of minimally invasive methods compared to open heart surgery include shortened recovery time, reduced post-operative pain, early recovery from work and normal daily activities.

However, there are still disadvantages in valve replacement therapy, and there is a need for percutaneous repair of diseased tricuspid valves.

Disclosure of Invention

One aspect of the present teachings provides a method of percutaneously reducing the circumference of a tricuspid annulus. The method includes several steps, the order of which may be changed, and each step may be omitted or modified without departing from the scope of the present teachings. An exemplary step includes positioning a positioning wire delivery catheter in the right ventricle through the tricuspid valve. Another exemplary step includes contacting a distal end of the positioning wire delivery catheter with the tricuspid annulus in the right ventricle at the first location. Another exemplary step includes advancing an end of a positioning wire at a first location from the right ventricle across the tricuspid annulus to the right atrium, wherein the positioning wire is advanced through an axial lumen of a positioning wire delivery catheter. Another exemplary step includes capturing an end of the positioning wire using a capture device positioned within the right atrium. Another exemplary step includes proximally retracting the capture device to bring the end of the positioning wire outside the body. Another exemplary step includes advancing a first tissue anchor delivery catheter over the positioning wire and extending the first tissue anchor delivery catheter across the tricuspid annulus such that a distal end of the first tissue anchor delivery catheter is located within the right ventricle. Another exemplary step includes deploying a first tissue anchor, wherein a portion of the tissue anchor is positioned against the tricuspid annulus from within the right ventricle. Another exemplary step includes deploying a first tissue anchor, wherein a portion of the tissue anchor is positioned against the tricuspid annulus from within the right atrium. Another exemplary step includes deploying the first tissue anchor, wherein a distal portion of the tissue anchor is positioned against the tricuspid annulus from within the right ventricle and a proximal portion of the tissue anchor is positioned against the tricuspid annulus from within the right atrium. Another exemplary step includes retracting the end of the positioning wire into the axial lumen of the positioning wire delivery catheter.

Another exemplary step includes contacting the distal end of the positioning delivery catheter with the tricuspid annulus at the second location in the right ventricle. Another exemplary step includes advancing an end of the positioning wire from the right ventricle across the tricuspid annulus to the right atrium. Another exemplary step includes capturing an end of the positioning wire using a capture device positioned within the right atrium. Another exemplary step includes proximally retracting the capture device, thereby extending the end of the positioning wire outside the body. Another exemplary step includes advancing a second tissue anchor delivery catheter over the positioning wire. Another exemplary step includes extending a second tissue anchor delivery catheter across the tricuspid annulus at a second location such that a distal end of the second tissue anchor delivery catheter is located within the right ventricle. Another exemplary step includes deploying a second tissue anchor, wherein a portion of the tissue anchor is positioned against the tricuspid annulus from within the right ventricle. Another exemplary step includes deploying a second tissue anchor, wherein a portion of the tissue anchor is positioned against the tricuspid annulus from within the right atrium. Another exemplary step includes deploying a second tissue anchor, wherein a distal portion of the tissue anchor is positioned against the tricuspid annulus from within the right ventricle and a proximal portion of the tissue anchor is positioned against the tricuspid annulus from within the right atrium. Another exemplary step includes reducing a distance between the first tissue anchor and the second tissue anchor.

In other embodiments, the method for percutaneously reducing the circumference of the tricuspid annulus includes a number of other steps, the order of which may be changed, and each step may be omitted or modified without departing from the scope of the present teachings. Exemplary steps include positioning a positioning catheter into the right ventricle across the tricuspid valve. Another exemplary step includes contacting a distal end of the positioning catheter with the tricuspid annulus in the right ventricle at the first location. Another exemplary step includes advancing a positioning wire delivery catheter into the right atrium, a distal end of the positioning wire delivery catheter opposite the distal end of the positioning catheter and contacting the tricuspid annulus within the right atrium at a first location. Another exemplary step includes advancing a distal end of a positioning wire from the right atrium across the tricuspid annulus to the right ventricle at a first location, wherein the positioning wire is advanced through an axial lumen of a positioning wire delivery catheter. Another exemplary step includes advancing a first tissue anchor delivery catheter over the positioning wire. Another exemplary step includes traversing the tricuspid annulus with the distal end of the first tissue anchor delivery catheter in the right ventricle. Another exemplary step includes deploying a first tissue anchor, wherein a portion of the tissue anchor is positioned against the tricuspid annulus from within the right ventricle. Another exemplary step includes deploying a first tissue anchor, wherein a portion of the tissue anchor is positioned against the tricuspid annulus from within the right atrium. Another exemplary step includes deploying the first tissue anchor, wherein a distal portion of the tissue anchor is positioned against the tricuspid annulus from within the right ventricle and a proximal portion of the tissue anchor is positioned against the tricuspid annulus from within the right atrium. Another exemplary step includes retracting the distal end of the positioning wire into the axial lumen of the positioning wire delivery catheter.

Another exemplary step includes contacting the distal end of the positioning catheter with the tricuspid annulus in the right ventricle at the second location. Another exemplary step includes positioning a positioning wire delivery catheter in the right atrium, a distal end of the positioning wire delivery catheter opposite the distal end of the positioning catheter, and contacting the tricuspid annulus within the right atrium at a second location. Another exemplary step includes extending a distal end of the positioning wire from the right atrium across the tricuspid annulus to the right ventricle. Another exemplary step includes advancing a second tissue anchor delivery catheter over the positioning wire and traversing the tricuspid annulus at a second location with a distal end of the second tissue anchor delivery catheter within the right ventricle. Another exemplary step includes deploying a second tissue anchor, wherein a portion of the tissue anchor is positioned against the tricuspid annulus from inside the right ventricle. Another exemplary step includes deploying a second tissue anchor, wherein a portion of the tissue anchor is positioned against the tricuspid annulus from within the right atrium. Another exemplary step includes deploying a second tissue anchor, wherein a distal portion of the tissue anchor is positioned against the tricuspid annulus from within the right ventricle and a proximal portion of the tissue anchor is positioned against the tricuspid annulus from within the right atrium. Another exemplary step includes reducing a distance between the first tissue anchor and the second tissue anchor.

In other embodiments, the method for percutaneously reducing the circumference of the tricuspid annulus includes a plurality of steps, the order of which may be varied, and each step may be omitted or modified without departing from the scope of the present teachings. Exemplary steps include positioning a positioning wire delivery catheter through the tricuspid valve into the right ventricle, wherein the dual-branch catheter is slidably disposed within a lumen of the positioning wire delivery catheter, the first positioning wire is slidably disposed within a first catheter member of the dual-branch catheter, and the second positioning wire is slidably disposed within a second catheter member of the dual-branch catheter. Another exemplary step includes positioning the distal end of the first catheter member at the first location. Another exemplary step includes traversing an end of the first positioning line from the right ventricle across the tricuspid annulus to the right atrium at the first location. Another exemplary step includes dilating a second catheter member of the dual-branch catheter. Another exemplary step includes positioning a distal end of the second catheter member against the tricuspid annulus at the second location. Another exemplary step includes advancing an end of a second positioning wire from the right ventricle across the tricuspid annulus to the right atrium at a second location. Another exemplary step includes capturing ends of the first and second position lines with a capture device. Another exemplary step includes proximally retracting the capture device and extending the ends of the first and second location lines outside the body. Another exemplary step includes advancing a first tissue anchor delivery catheter over a first location line and advancing a second tissue anchor delivery catheter over a second location line. Another exemplary step includes traversing the tricuspid annulus with the first and second tissue anchor delivery catheters within the right ventricle. Another exemplary step includes deploying first and second tissue anchors, wherein portions of the first and second tissue anchors are positioned against the tricuspid annulus from within the right ventricle. Another exemplary step includes deploying first and second tissue anchors, wherein portions of the first and second tissue anchors are positioned against the tricuspid annulus from within the right atrium. Another exemplary step includes deploying the first and second tissue anchors, wherein distal end portions of the first and second tissue anchors are positioned against the tricuspid annulus from within the right ventricle and proximal end portions of the first and second tissue anchors are positioned against the tricuspid annulus from within the right atrium. Another exemplary step includes reducing a distance between the first tissue anchor and the second tissue anchor.

In other embodiments, the method for percutaneously reducing the circumference of the tricuspid annulus includes a plurality of steps, the order of which may be varied, and each step may be omitted or modified without departing from the scope of the present teachings. Exemplary steps include positioning a positioning catheter in the right ventricle through the tricuspid valve, wherein a dual-limb catheter is slidably disposed in a lumen of the positioning catheter, and the dual-limb catheter has a first catheter member and a second catheter member. Another exemplary step includes positioning the distal end of the first catheter member at the first location. Another exemplary step includes expanding a second catheter member of the dual-branch catheter and positioning a distal end of the second catheter member against the tricuspid annulus at a second location. Another exemplary step includes advancing the first and second positioning wire delivery catheters into the right atrium, the distal ends of the first and second positioning wire delivery catheters being positioned opposite the distal ends of the first and second catheter members. Another exemplary step includes the first and second positioning wire delivery catheters contacting the tricuspid annulus in the right atrium at the first and second locations. Another exemplary step includes advancing distal ends of the first and second positioning wires across the tricuspid annulus to the right ventricle at the first and second locations. Another exemplary step includes advancing the first and second tissue anchor delivery catheters over the first and second positioning wires and traversing the tricuspid annulus with distal ends of the first and second tissue holder delivery catheters within the right ventricle. Another exemplary step includes deploying first and second tissue anchors, wherein portions of the first and second tissue anchors are positioned against the tricuspid annulus from within the right ventricle. Another exemplary step includes deploying first and second tissue anchors, wherein portions of the first and second tissue anchors are positioned against the tricuspid annulus from within the right atrium. Another exemplary step includes deploying the first and second tissue anchors, wherein distal end portions of the first and second tissue anchors are positioned against the tricuspid annulus from within the right ventricle and proximal end portions of the first and second tissue anchors are positioned against the tricuspid annulus from within the right atrium. Another exemplary step includes reducing a distance between the first tissue anchor and the second tissue anchor.

Another aspect of the present teachings relates to reducing the circumference of the tricuspid valve by deploying two or more tissue anchors and/or fasteners and connecting the tissue anchors and/or fasteners with one or more tensioning members. In various embodiments, at least two of the two or more tissue anchors and/or fasteners are connected with a continuous portion of the tensioning member. In some embodiments, three of the two or more tissue anchors and/or fasteners are connected with a continuous portion of the tensioning member. In some embodiments, all two or more tissue anchors and/or fasteners are connected with a continuous portion of the flexible tensioning member. In various embodiments, at least one of the two or more tissue anchors is configured to slide along the flexible tensioning member. This configuration may sometimes be referred to as a chain tissue anchor, i.e., each of the tissue anchor and fastener are connected by a tensioning member known as a chain or rope.

In various embodiments, tension is applied to a tensioning member connecting two or more tissue anchors and/or fasteners of the present teachings, thereby reducing the distance between at least two of the tissue anchors and/or fasteners. As a result, in some embodiments, the tissue between at least two tissue anchors and/or fasteners is folded. In certain embodiments, two or more distances are reduced, wherein each distance is between two tissue anchors and/or fasteners of the present teachings, and the tissue between each pair of tissue anchors and/or fasteners is folded. This folding may sometimes be referred to as chain folding. In various embodiments, the folding of tissue between the tissue anchors and/or fasteners reduces the circumference of the tricuspid valve and eliminates or reduces the extent of tricuspid valve regurgitation.

Another aspect of the present teachings relates to various tissue anchors and/or fasteners. In various embodiments, the tissue anchors of the present teachings include a flexible anchoring element coupled with a flexible tensioning member. For example, the flexible anchor may be made of a surgical grade fabric material and the flexible tensioning member may be a suture. In some embodiments, the first portion of the flexible anchoring element is positioned on one side of the tricuspid valve, such as one side of the tricuspid annulus. In some embodiments, the second portion of the flexible anchoring element is seated on the other side of the tricuspid annulus. In some embodiments, a third portion of the flexible anchoring element, such as a portion adjacent to the first portion or the second portion, is placed in or through an aperture in the tricuspid annulus tissue. In various embodiments, the tissue anchors of the present teachings include a T-bar coupled with a tensioning member (sometimes referred to as a tail). In various embodiments, the tissue anchors of the present teachings include an anchor button coupled with a flexible tensioning member. In various embodiments, the tissue anchors of the present teachings include a fastener coupled with a flexible tensioning member. In various embodiments, the tissue anchors of the present teachings include two radially expandable portions. In various embodiments, the tissue anchors of the present teachings include a rod, a strap, and a flexible tensioning member, wherein the strap is coupled with the rod, the flexible tensioning member, or both. Various other embodiments of the tissue anchor may also be used to fold the tricuspid annulus, effectively reducing the circumference of the tricuspid annulus and reducing or eliminating tricuspid regurgitation.

Another aspect of the present teachings relates to devices that can be used to deliver the tissue anchors of the present teachings and repair the tricuspid valve. Certain embodiments of the present teachings relate to a push wire having a retainer coupled with a putative bitline having an elongated wire, a rounded distal end, one or more than one marker, or a combination thereof.

Drawings

1A-1B are perspective views of embodiments of the present teachings in which tension is applied to a plurality of exemplary tissue anchors deployed across the tricuspid annulus according to the present teachings.

Fig. 2 is a perspective view of an exemplary guide for percutaneous insertion into the right atrium according to the present teachings.

3A-3B are perspective views of an exemplary positioning wire delivery catheter inserted into the right ventricle in accordance with the present teachings.

4A-4B are perspective views of an exemplary capture device positioned in the right atrium according to the present teachings.

5A-5B are perspective views of exemplary positioning wires positioned across a ring according to the present teachings.

FIG. 6 is a perspective view of an exemplary positioning wire captured and pulled through a guide according to the present teachings.

FIG. 7 is a perspective view of an exemplary positioning wire positioned across a ring according to the present teachings.

8A-8B are perspective views of an exemplary positioning catheter inserted into the right ventricle in accordance with the present teachings.

8C-8D are perspective views of exemplary locating wires traversing the ring according to the present teachings.

9A-9B are perspective views of an exemplary positioning device inserted into the right ventricle in accordance with the present teachings.

FIG. 10 is a perspective view of an exemplary positioning wire positioned across a ring according to the present teachings.

11A-11C are perspective views of an exemplary tissue anchor deployed across the tricuspid annulus according to the present teachings.

Fig. 12A-12C are perspective views of an exemplary tissue anchor deployed across the tricuspid valve according to the present teachings.

Fig. 13A-13B are perspective views of an exemplary tissue anchor deployed across the tricuspid valve according to the present teachings.

14A-14C are perspective views of an exemplary method according to the present teachings in which an exemplary second positioning wire extends across the tricuspid annulus.

Fig. 15A-15B are perspective views of an exemplary second tissue anchor deployed across the tricuspid valve according to the present teachings.

Fig. 16 is a perspective view of the application of tension to two exemplary tissue anchors deployed across a loop in accordance with the present teachings.

FIG. 17 is a perspective view of an exemplary dual-branch catheter according to the present teachings.

18A-18B are perspective views of examples of placement of two exemplary positioning wires across the tricuspid annulus with an exemplary dual-branch catheter according to the present teachings.

19A-19B are perspective views of examples of placement of two exemplary positioning wires across the tricuspid annulus with an exemplary dual-branch catheter according to the present teachings.

Fig. 20A-20P are various exemplary tissue anchors according to the present teachings.

21A-21C are side perspective views illustrating an annuloplasty procedure in which two tissue anchors of an embodiment of the present teachings are tissue anchors linked together with a single tensioning member to fold tissue between the anchors according to the present teachings.

Fig. 22A and 22B are representations of alternative embodiments of tissue anchors and locks for use in an exemplary process of creating a chain fold in accordance with the present teachings.

23A and 23B illustrate another alternative embodiment linked together by tensioning members to fold tissue between tissue anchors according to the present teachings.

Figures 24A-24C illustrate another alternative embodiment linked together by tensioning members to fold tissue between tissue anchors according to the present teachings,

25A-25C illustrate another alternative embodiment linked together by tensioning members to fold tissue between tissue anchors according to the present teachings.

Fig. 26A-26E illustrate another alternative embodiment of tissue anchors linked together to fold tissue between the tissue anchors in accordance with the present teachings.

Fig. 27A and 27B illustrate another alternative embodiment of tissue anchors linked together to fold tissue between the tissue anchors in accordance with the present teachings.

28A and 28B illustrate distal portions of exemplary push wires according to the present teachings.

FIG. 29A illustrates a distal portion of an exemplary delivery catheter according to the present teachings; FIG. 29B illustrates a cross-sectional view of the distal portion of the exemplary delivery catheter of FIG. 29A in accordance with the present teachings; and fig. 29C illustrates a cross-sectional view of the distal portion of the exemplary delivery catheter of fig. 29A with an exemplary push wire and an exemplary tissue anchor slidably disposed in the exemplary delivery catheter in accordance with the present teachings.

Detailed Description

Certain specific details are set forth in the following description and figures to provide an understanding of various embodiments of the present teachings. One of ordinary skill in the relevant art will understand that they can practice other embodiments of the present teachings without requiring each and every one or more of the details described herein. It is therefore not the intention of the applicants to restrict or in any way limit the scope of the appended claims to such detail. Although various processes are described with reference to steps and sequences in the following disclosure, the steps and sequences of steps should not be construed as necessary to practice all embodiments of the present teachings.

As used herein, the term "lumen" refers to a tube, duct, or generally tubular space or cavity within a subject, including veins, arteries, blood vessels, capillaries, the intestine, and the like. The term "lumen" may also refer to a tubular space in a catheter, sheath, hollow needle, tubing, etc.

As used herein, the term "proximal" shall mean closer to the operator (shallower into the body), while "distal" shall mean farther away from the operator (deeper into the body). When positioning a medical device within a patient, "distal" refers to a direction away from the catheter insertion site, and "proximal" refers to a direction closer to the insertion site.

As used herein, the term "thread" may be strand, cord, fiber, yarn, filament, cable, filament, etc., and these terms may be used interchangeably.

As used herein, the term "sheath" may also be described as a "catheter", and thus these terms may be used interchangeably.

Unless otherwise indicated, all numbers expressing quantities, measurements, and other properties or parameters used in the specification and claims are to be understood as being modified in all instances by the term "about". Accordingly, unless indicated otherwise, it is understood that the numerical parameters set forth in the following specification and attached claims are approximations. At the very least, and not as an attempt to limit the application of the doctrine of equivalents to the scope of the appended claims, numerical parameters should be read in light of the number of reported significant digits and the application of ordinary rounding techniques.

The present teachings relate to devices and methods for percutaneous treatment of tricuspid valve regurgitation. Although illustrated in fig. 1-29 with reference to the figures, those of ordinary skill in the art will recognize that the figures and their descriptions relate to various embodiments of the present teachings and, unless otherwise specified, should not limit the scope of the appended claims to the figures and/or their descriptions.

Headings and sub-headings are used herein for convenience of disclosure and discussion only and should not be used in any way to limit the scope of the appended claims.

Reducing circumference of tricuspid valve

One aspect of the present teachings relates to a method of reducing the circumference of a tricuspid valve (2). For example, referring now to fig. 1A and 1B, the circumference of the tricuspid valve (2) may be reduced by placing a plurality of connected tissue anchors or fasteners (1A, 1B, 1c, 1d, 1e, 1f) of the present teachings around the tricuspid annulus (3) and applying tension to the tensioning members to fold the tissue between each pair of tissue anchors/fasteners.

Specifically, as shown in fig. 1A, according to some embodiments, a first tissue anchor (1A) is seated in or near the tricuspid annulus (3). The necessary number of tissue anchors can be repeatedly deployed as many times as desired. Referring again to fig. 1A, the first tissue anchor (1A) is placed at or near the junction of the posterior leaflet loop and the spacing leaflet loop, and the second through fifth tissue anchors (1b, 1c, 1d, 1e) are placed at locations between and at the junction of the posterior leaflet loop and the spacing leaflet loop, as shown in fig. 1A. In some embodiments, a sixth tissue anchor (1f) is placed in the anterior ring at or near the junction of the posterior and anterior leaflet rings, as shown in fig. 1A.

In various embodiments, two or more of the tissue anchors (1a-1f) are connected with a tensioning member (5). In some embodiments, two of the tissue anchors are connected with a tensioning member (5). In some embodiments, three of the tissue anchors are connected with a tensioning member (5). In some embodiments, four of the tissue anchors are connected with a tensioning member (5). In some embodiments, five of the tissue anchors are connected with a tensioning member (5). In some embodiments, six of the tissue anchors are connected with a tensioning member (5). In other embodiments for deploying more than six tissue anchors, more than six tissue anchors are connected to the tensioning member (5). In various embodiments, two, three, four, five, six, or more than six of the deployed tissue anchors are slidably connected with the tensioning member (5). Thus, when tension is applied to the tensioning member, two, three, four, five, six, or more than six deployed tissue anchors are pulled toward each other and the distance between each pair of tissue anchors is reduced.

In reducing the distance between the six tissue anchors (1a-1f), the circumference of the tricuspid annulus is reduced, effectively reducing the size of the tricuspid valve, as shown in fig. 1B. In other words, the circumference of the tricuspid annulus (3) is reduced, thereby promoting coaptation of the leaflets of the tricuspid valve (2) and reducing or eliminating the tricuspid regurgitation jet. Thus, the tricuspid valve (2) can be completely closed during contraction of the right ventricle.

One of ordinary skill in the art will appreciate that fig. 1A-1B illustrate only certain embodiments of the present teachings, that other locations may be used to place tissue anchors, and/or that other numbers of tissue anchors/fasteners may be used to reduce the circumference of the tricuspid annulus.

According to some embodiments, all of the tissue anchors (1a-1f) are positioned along the posterior leaflet loop. According to other embodiments, all of the tissue anchors (1a-1f) are positioned along the anterior leaflet loop. According to other embodiments, at least one tissue anchor (1a) is positioned on the posterior leaflet loop, while another tissue anchor (1b-1f) is placed on the anterior loop. In other embodiments, one or more tissue anchors are placed on the spacer ring. According to other embodiments, at least one tissue anchor (1a) is placed at or near the junction of the posterior leaflet loop and the spacing leaflet loop, and other tissue anchors (1b-1e) are placed at locations between the junction of the posterior leaflet loop and the spacing leaflet loop and the junction of the posterior leaflet loop and the anterior leaflet loop. According to other embodiments, one tissue anchor (1f) is placed at or near the junction of the posterior and anterior leaflet loops. According to other embodiments, at least one tissue anchor (1a) is placed at or near the junction of the anterior and spaced leaflet rings, and other tissue anchors (1b-1e) are placed at locations between the junction of the anterior and spaced leaflet rings and the junction of the posterior and anterior leaflet rings. According to other embodiments, one tissue anchor (1f) is placed at or near the junction of the posterior and anterior leaflet loops.

According to some embodiments, two tissue anchors (1a and 1b) are placed around the circumference of the ring. According to other embodiments, more than two tissue anchors (e.g., six tissue anchors 1a-1f) are deployed around the circumference of the ring. In some embodiments, three tissue anchors are deployed around the circumference of the ring. In some embodiments, four tissue anchors are deployed around the circumference of the ring. In some embodiments, five tissue anchors are deployed around the circumference of the ring. In some embodiments, more than six tissue anchors are deployed around the circumference of the ring.

Additionally, according to some embodiments, tension is applied to all of the tissue anchors. According to other embodiments, tension is applied to some tissue anchors. In some embodiments, tension is applied to two of the tissue anchors. In some embodiments, tension is applied to three, four, five, six, or more than six of the tissue anchors.

Positioning and deploying tissue anchors

Another aspect of the present teachings relates to positioning a first location on the tricuspid annulus. According to some embodiments, the first location is on or around the aft ring at the junction of the aft and spacer rings. According to some embodiments, the first position is located on the spacer ring at or around the junction of the aft and spacer rings. According to some embodiments, the first location is on or around the aft ring at a junction of the aft and forward leaflet rings. According to some embodiments, the first position is on the anterior ring at or about the junction of the posterior and anterior leaflet rings.

Another aspect of the present teachings provides various embodiments for placing a positioning wire across the tricuspid annulus (3) at a first location. According to some embodiments, the positioning wire traverses across the tricuspid annulus (3) from the right atrium to the right ventricle (4). According to some embodiments, the location wire of the present teachings traverses across the tricuspid annulus (3) from the right ventricle to the right atrium (8).

Another aspect of the present teachings provides various embodiments for deploying a tissue anchor over a positioning wire and across the tricuspid annulus. According to some embodiments, a portion of the tissue anchor is deployed within the right ventricle (4). According to some embodiments, a portion of the tissue anchor (310a) is positioned within the right atrium (8). According to some embodiments, the distal portion of the tissue anchor is positioned within the right ventricle (4) and the proximal portion of the tissue anchor (310a) is positioned within the right atrium (8). According to some embodiments, the distal portion of the tissue anchor (310a) is positioned within the right atrium (8) and the proximal portion of the tissue anchor (310a) is positioned within the right ventricle (4). The distal and proximal portions of the first tissue anchor are adjacent each side of the loop.

Another aspect of the present teachings provides various embodiments for positioning a second location on the tricuspid annulus (3), placing a second positioning wire across the tricuspid annulus (3), and then deploying a second tissue anchor across the tricuspid annulus. According to some embodiments, the second tissue anchor is adjacent to the first tissue anchor and at the posterior leaflet loop. According to other embodiments, the second tissue anchor is adjacent to the first tissue anchor and at the anterior leaflet loop. And according to some embodiments, the second tissue anchor is adjacent to the first tissue anchor and at the spaced leaflet ring. Similarly, according to some embodiments, a portion of the second tissue anchor is deployed within the right ventricle (4). According to some embodiments, a portion of the second tissue anchor (310a) is positioned within the right atrium (8). According to some embodiments, the distal portion of the second tissue anchor is positioned within the right ventricle (4) and the proximal portion of the tissue anchor (310a) is positioned within the right atrium (8). According to some embodiments, the distal portion of the second tissue anchor (310a) is positioned within the right atrium (8) and the proximal portion of the tissue anchor (310a) is positioned within the right ventricle (4). The distal and proximal portions of the second tissue anchor are adjacent each side of the loop.

Another aspect of the present teachings provides various embodiments for reducing the circumference of the tricuspid annulus (3).

An exemplary method of the present teachings begins with percutaneous access to the tricuspid annulus (3) from a suitable venous access location. According to some embodiments, the venous access location is located near the jugular vein, preferably at the femoral vein, inferior or other suitable location.

According to some embodiments of the present teachings, as shown in fig. 2, a suitable guide (12) is guided into the jugular vein, extending through the right brachiocephalic vein and the superior vena cava (6), and reaching the right atrium (8). The distal end (10) of the guide (12) is retained within the right atrium (8). The proximal end (not shown) of the guide (12) remains outside the body. The guide (12) has an axial lumen (14) throughout its entire length from its proximal end to its distal end (10). The axial lumen (14) of the guide (2) serves as a conduit allowing one or more catheters to be slidable therethrough, disposed within the right heart chamber to provide access to the right heart chamber. According to some embodiments, the guide (12) remains in place as shown in fig. 2 throughout the process. According to some embodiments, the guide (12) is removed while other suitable devices (e.g., a positioning wire) maintain such percutaneous access, for example, during a surgical procedure.

According to some embodiments, the guide (12) is a 12-flange (F) sheath. According to some embodiments, the guide (12) is a single lumen sheath that can accommodate all subsequent catheters for sliding therein. Alternatively, in some embodiments, the guide (12) is a multi-lumen sheath. Those of ordinary skill in the art will appreciate that the dimensions and precise configuration of the guide (12) are not limited to that disclosed herein.

In various embodiments, percutaneous repair of the tricuspid valve (2) begins by identifying and obtaining access to a first location on the tricuspid annulus (3). Fig. 3-7 illustrate some embodiments in which a positioning wire gains access from the right ventricle (4) to the tricuspid valve (2) and is advanced across the tricuspid annulus (3) into the right atrium (8). In doing so, the distal end of the positioning wire extends from a venous entry location, through the lumen (14) of the guide (12), to the right atrium (8), distally through the tricuspid valve (2), to the right ventricle (4), advances across the tricuspid annulus (2), and extends proximally out of the body through the lumen (14) of the guide (12). The result is that both ends of the localizing wire are outside the body.

Fig. 3A shows an embodiment in which the positioning wire delivery catheter (20) is guided into the right ventricle (4). In one embodiment, a positioning wire delivery catheter (20) is inserted from the proximal end of the guide (12) through the lumen (14) of the guide (12) and to the right atrium (8). As shown in fig. 3A, when the distal end (24) of the positioning wire delivery catheter (20) extends beyond the distal end (10) of the guide (12), the positioning wire delivery catheter (20) extends further distally through the opening among the leaflets of the tricuspid valve (2) and to the right ventricle (4). Within the right ventricle (4), the distal portion (22) of the positioning wire delivery catheter (20) is radially curved, away from the longitudinal axis of the positioning wire delivery catheter (20), and assumes a curved configuration. According to some embodiments, the curved configuration of the distal portion (22) of the positioning wire delivery catheter (20) is the letter "J", the letter "U", or a shape of any curvature between 90 ° and 270 °, as labeled "θ" in fig. 3A.

According to some embodiments, the distal portion (22) of the positioning wire delivery catheter (20) has a predetermined shaped curved configuration line such that when the distal end (24) of the positioning wire delivery catheter exits the constraint of the guide (12) and enters the right ventricle (4), the distal portion (22) of the positioning wire delivery catheter (20) resumes its curved configuration. According to some other embodiments, the positioning wire delivery catheter (20) has a deflectable distal portion (22) that is actuated to form a curved configuration. It should be understood that the various catheters disclosed herein may have a distal portion that may be steerable in various ways for precise positioning purposes. For example, the distal portion of the positioning wire delivery catheter may be movable to a desired hooked position by a guide cable embedded in the lumen wall of the catheter, which may be pulled to configure the distal portion of the catheter in a hook shape as shown. In some embodiments, a catheter as used herein includes a one-way or two-way steering mechanism. The steering mechanism may be located within and/or on the device. Typically, the steering mechanism may include a pull wire terminating in a flat spring or collar. The steering mechanism has a more flexible distal portion than the proximal catheter tube. When tension is placed on the pull wire, the distal end of the catheter is bent into a configuration that allows the device to be accurately manipulated within the heart chamber. The pull wire may be coiled, crimped, spot welded or welded to a flat spring or collar (not shown) placed in the end of the catheter. This provides a stable point within the device for the pull wire to apply tension and thus steer the device. The proximal portion of the catheter may be provided by incorporating helically wound or braided wires therein to provide a post support that better deflects the distal portion. Alternatively, the steering mechanism may be composed of a superelastic material having a suitable three-dimensional geometry at its distal end and sufficient stiffness to impart that shape in the device. The distal end of the device is straightened by retracting the preformed steering line back into the rigid proximal portion of the device. Extending the preformed steering line into the more flexible distal portion of the device, causing the distal portion to assume the shape of the steering line. Alternatively, a device having a curved portion may incorporate a tube or rod that can be advanced through the portion to straighten it. An additional feature that may be incorporated into the device is a preformed shape in the distal portion of the device. The distal portion may be preformed into a curved configuration that biases the device to maximize tissue contact when the device is positioned in an appropriate heart chamber. The curved configuration may be comprised of a single arc or a non-linear geometry (e.g., "S"). A preform, hypotube, wire or coil made of a memory elastic material such as nickel titanium or spring steel can be thermoformed into the desired geometry and inserted into the distal portion of the device (including the individual lumens) during the manufacturing process or advanced through a dedicated lumen during placement of the device in the heart. The shaped wire may be attached to the distal tip of the device for those non-movable pre-shaped rods and fixed at its proximal end to the handle of the device to provide a reinforcing structure over the entire length of the device. The device body may also or alternatively be thermoformed into a desired geometry.

According to some embodiments, the positioning wire delivery catheter (20) may be distally extended, proximally retracted, or axially rotated, as indicated by the double-headed arrow in fig. 3A.

As further shown in fig. 3B, the distal end (24) of the positioning wire delivery catheter (20) is adapted to be positioned in a first position (32) and then in contact with the tricuspid annulus (3) on the right ventricular (4) side.

Anatomically, the right coronary artery is approximately parallel to the circumference of the tricuspid valve (2). The anterior and septal leaflets are located approximately in the proximal half of the right coronary artery. The posterior leaflet of the tricuspid valve is located approximately in the distal half of the right coronary artery, between the middle of the right coronary artery and the transition of the distal right coronary artery to the posterior inferior artery. The middle of the right coronary artery is approximately located beside the junction of the anterior and posterior leaflets. The transition of the distal right coronary artery to the posterior inferior artery or the proximal posterior inferior artery is located approximately alongside the junction of the septal leaflet and the posterior leaflet. One skilled in the art will appreciate that the anatomy of the heart may vary from subject to subject, and the present teachings and appended claims are not limited to the anatomy of any particular subject.

According to some embodiments, the first location is identified (32) by injecting contrast agent in the right coronary artery and the distal posterior inferior artery. Alternatively, the location may be identified by advancing the radiopaque marker through the right coronary artery to the posterior inferior artery. In various embodiments, the contrast agent and/or radiopacity makes the right coronary artery visible under radiographic imaging equipment (e.g., X-ray, magnetic resonance, ultrasound, fluoroscopy, or other imaging techniques). By making the right coronary artery and the posterior inferior artery visible, the location can be identified. Other methods of identifying the first location may also be used without departing from the scope of the present teachings.

Upon identifying the first location (32), in various embodiments, the clinician turns the positioning wire delivery catheter such that the distal end (24) of the positioning wire delivery catheter (20) is aligned at the tricuspid annulus (3), extends upward inside the right ventricle (4), and contacts the tricuspid annulus (3) at the first location (32), as shown in fig. 3B. According to one embodiment, the first location (32) is at or near the junction of the spacer and aft leaflet rings. Alternatively, the first position (32) is at or near the junction of the anterior and posterior leaflet rings. Those skilled in the art will appreciate that other locations along the tricuspid annulus (3) may be used as the first location.

In various embodiments, the capture device (34) is positioned within the right atrium (8) while the distal end (24) of the localizing wire delivery catheter (20) is aligned to the first location (32). Fig. 4A shows an embodiment where the capture device (40) is advanced distally through the guide (12) and into the right atrium (8). According to some embodiments, the capture device (40) includes a sheath (42) and a capture basket (44). In some embodiments, a capture device (such as the one shown in fig. 4A) includes a capture basket (44) having an array of shape memory wire meshes on a distal end (48) of a rod (46). According to some embodiments, the capture basket (44) has a basket-like configuration for radial expansion of the capture line as described below, and has an elongated configuration when constrained within the sheath (42). In some embodiments, the catch basket (44) as shown in fig. 4A is adapted to be slid through the axial lumen (41) of the sheath (42), pushed out of the distal end (43) of the sheath (42), and retracted from the distal end (43) of the sheath (42). In some embodiments, the capture basket (44) resumes its expanded configuration when it extends outside the distal end (43) of the sheath (42). When the catch basket (44) is retracted into the sheath (42), it contracts to its elongate configuration. Those skilled in the art will appreciate that the catch basket (44) may be used without the sheath (42) and with only the guide (12). Accordingly, what is described herein should not be considered limiting.

In an exemplary use of the device, as shown in fig. 4A, a capture device (40) is introduced through the lumen (14) of the guide (12), the capture device (40) having a capture basket (44) constrained in its elongated configuration within a sheath (42). According to some embodiments, when a multi-lumen sheath is used as a guide, the capture device (40) extends through a lumen separate from the lumen used by the positioning wire delivery catheter (20). According to other embodiments, when a single lumen sheath is used as the guide, the capture device (40) extends through the same lumen of the guide alongside the positioning wire delivery catheter (20). Once the distal end of the capture device (40) is advanced beyond the distal end (10) of the guide (12) and to the right atrium (8), the capture basket (44) is advanced further distally outside of the sheath (42) and unconstrained by the sheath (42), thereby seating the capture basket (44). In some embodiments, the emplaced capture basket (44) may at least partially fill the volume of the right atrium (8).

Fig. 4B shows another embodiment of the capture device (50). According to some embodiments, the capture device (50) includes a capture basket (52) at a distal end (54) of an elongated body (56). In some embodiments, a capture device (50) including an elongate body (56) and a capture basket (52) forming an axial lumen is slidably disposed over a positioning wire delivery catheter (20). Similar to the embodiment shown in fig. 4A, the capture basket (52) is adapted to slide through the axial lumen (14) of the guide (12). Also similar to the embodiment shown in fig. 4A, the capturing basket (52) has an elongated configuration when constrained within the lumen (14) of the guide (12), and a radially expanded basket-like configuration when the capturing basket (52) is external to the guide (12). Similarly, in some embodiments, the capture basket (52) may be made of an array of shape memory wire mesh.

According to some embodiments, the capture device (50) is adapted to slide through the lumen (14) of the guide (12) over the positioning wire delivery catheter (20) and be pushed out of the distal end (10) of the guide (12). According to some embodiments, the capture device (50) returns to its expanded configuration when it extends outside the distal end (10) of the guide (12). According to some embodiments, when the capture device (50) is retracted into the lumen (14) of the guide (12), it contracts to its elongated configuration. According to some embodiments, the movement of the capture device (50) is independent of the movement of the positioning wire delivery catheter (20). According to other embodiments, the movement of the capture device (50) is dependent on the movement of the positioning wire delivery catheter (20). In certain embodiments, when the distal end (24) of the positioning wire delivery catheter (20) contacts the tricuspid annulus (3), the capture basket (52) extends outside of the guide (12) and is fully seated within the right atrium (8). While certain embodiments of a catch basket (52) are shown in fig. 4A and 4B, those skilled in the art will appreciate that other catch means may be used without departing from the spirit of the present teachings. Accordingly, the disclosure in the present teachings should not be considered limiting.

In addition to having a capture basket, according to other embodiments, the capture device includes a sheath having an expandable distal portion or snare. Those skilled in the art will appreciate that other types of suitable capture devices may be used therein. Accordingly, the disclosure herein and in FIGS. 4A-4B should not be taken as limiting.

In various embodiments, after the capture basket and positioning wire delivery catheter (20) housed within the right atrium (8) are properly positioned, the clinician may extend the positioning wire (60a) across the tricuspid annulus (3). In some embodiments shown in fig. 5A, the guidewire is introduced through a guidewire delivery catheter (20). In these embodiments, the positioning wire (60a) travels through the axial lumen (26) of the positioning wire delivery catheter (20), extends from its proximal end to its distal end, contacts the tricuspid annulus (3), further extends and traverses from the right ventricle (4) side, across the tricuspid annulus (3), into the right atrium (8), and into the space filled by the capture baskets (44, 52). In some embodiments, the distal portion of the positioning wire is captured by the capture basket.

According to some embodiments, as shown in fig. 5A, the positioning wire (60a) has a piercing tip that allows it to perforate the tricuspid annulus (3). According to other embodiments, the positioning wire (60a) has a Radio Frequency (RF) energy delivery tip to assist its traversal through the tricuspid annulus (3). In these other embodiments, a suitable radiofrequency energy device (not shown) is coupled to the positioning wire.

However, according to other embodiments, as shown in fig. 5B, the positioning wire delivery catheter (20) further comprises an extendable needle (28) capable of piercing the tricuspid annulus (3). In these embodiments, a positioning wire (60a) is advanced through the lumen (26) of such a positioning wire delivery catheter (20), extending through the lumen of the extendable needle, alternatively, through the hole created by the extendable needle (28) of the positioning wire delivery catheter (20), into the right atrium (8), and into the space filled by the capture basket (44, 52). In some embodiments, a distal portion of the positioning wire is captured by a capture basket (44, 52). Those skilled in the art will appreciate that other methods and devices may be used to access the right atrium (8). Accordingly, the specific embodiments described herein should not be construed as limiting the scope of the present teachings.

Various systems of the present teachings may also include different ways of ensuring that the catheter device is properly positioned adjacent to the tissue prior to use. For example, the impedance measurement device may be coupled to the perforated element itself, such as a radio frequency wire, or to electrodes on the perforated element or any separate element carried by the system. Such a proximity determination device may be used to confirm contact between the catheter device and the tissue surface by comparing the impedance between the electrode (e.g., RF line) and the return path (extraneous patch or second element electrode). When the electrode contacts only blood, the impedance is substantially higher than when the electrode element is in contact with the tissue surface. Each electrode is connected to a signal line, which is connected to an impedance measuring device. The signal line may be connected to the impedance measuring device by a connector and cable system. The measuring device may be a power supply, a simple resistance meter, or any other suitable device and method of use.

According to some embodiments, the distal portion (62) of the positioning wire (60a) is designed to deflect or crimp to prevent accidental tissue damage. The ability to deflect or crimp may be achieved by the geometry of the positioning wire (60a), such as a distal portion having a relatively small cross-sectional configuration (62), through the physical properties of the material used to fabricate the positioning wire (60a), or through the shape memory properties of the material used to fabricate the positioning wire (60 a). Those skilled in the art will be able to combine known techniques and/or materials to achieve this end without undue experimentation.

Referring now to fig. 6, when the distal portion of the positioning wire enters the right atrium (8) and the space filled by the seated capture basket (44, 52), it is captured by the capture basket (44, 52) of the capture device (40, 50). When the clinician retracts the capture basket (44) proximally into the sheath (42) or guide (12), the capture basket (44, 52) is retracted onto the distal portion of the positioning wire (60 a). As the clinician further proximally retracts the capture device (40, 50), the capture device (40, 50) pulls the distal portion of the positioning wire (60a) proximally through the lumen (14) of the guide (12) and out of the body.

In various embodiments, the clinician further retracts the capture device (40) including the sheath (42) and capture basket (55), as shown in fig. 4A, or retracts the elongate member (56) including the capture basket (52), as shown in fig. 4B, proximally through the lumen (14) of the guide (12) to outside the body. By doing so, in some embodiments, the clinician pulls the distal end of the positioning wire (60a) outside the body. As a result, as shown in fig. 7, when one end of the positioning wire (60a) is held outside the body, the other end extends the positioning wire distally from the venous entry location through the lumen (26) of the positioning wire delivery catheter (20), through the right atrium (8), the opening in the leaflets of the tricuspid valve (2), and the right ventricle (4), across the tricuspid annulus (3) at the first location (32), then extends proximally through the lumen (14) of the guide (12), and exits the venous entry location. Thus, in many embodiments, both ends of the positioning wire are external to the body, and the positioning wire (60a) maintains a pathway across the tricuspid annulus (3) at the first location (32) and facilitates the deployment of a tissue anchor as described in detail below.

Fig. 8-10 illustrate some embodiments in which a positioning wire (160a) extends from the right atrium (8) across the tricuspid annulus (3) into the right ventricle (4), wherein the proximal end of the positioning wire (160a) is outside the body and the distal end (162) of the positioning wire (160a) is within the right ventricle. According to some embodiments, the location line is positioned at the first location by means of a visualization tool, such as fluoroscopy or echocardiography. According to other embodiments, the location wire is placed at a first location across the loop with a location device, such as described herein.

Fig. 8A-8C illustrate various embodiments of positioning of a wire delivery catheter (120) against the tricuspid annulus by a positioning catheter (100). According to some embodiments, a positioning catheter (100) extends distally through a lumen (14) of the guide (12), through an opening in the tricuspid leaflet and into the right ventricle (4). In certain embodiments, the positioning catheter (100) enters the right ventricle in a manner similar to the positioning wire delivery catheter (20) described with respect to fig. 3A and 3B. After the same identification and placement procedure as described herein, in various embodiments, the positioning catheter (100) is positioned against the tricuspid annulus (3) at a first location (32) within the right ventricle (4). According to some embodiments, the positioning catheter (100) is similar in construction to the positioning wire delivery catheter (20) described above. In certain embodiments, the positioning catheter has a pre-shaped or actuated curved distal portion (102). In some embodiments, the positioning catheter can be extended distally and retracted proximally, as indicated by the straight double-headed arrow in fig. 8A. In certain embodiments, the positioning catheter is adapted to rotate in an axial direction, as indicated by the curved double-headed arrow in FIG. 8A.

With continued reference to fig. 8A, in various embodiments, the positioning catheter (100) has a magnet (106) at its distal end (104). In various embodiments, the positioning wire delivery catheter (120) is advanced distally through the lumen (14) of the guide (12) into the right atrium (8) and proximate to the tricuspid annulus (3). According to some embodiments, one of which is shown in fig. 8B, the distal end (124) of the positioning wire delivery catheter (120) includes a magnet (126). In various embodiments, the magnets (106, 126) on the positioning catheter (100) and the positioning wire delivery catheter (120) have opposite polarities. Thus, in some embodiments, when the positioning wire delivery catheter (120) is proximate to the tricuspid annulus (3), the magnet in the distal end of the positioning wire delivery catheter is attracted to the magnet (106) on the distal end (104) of the positioning catheter (100). In some embodiments, once the magnets (106, 126) are locked, the tricuspid ring (3) is sandwiched between the distal ends (124, 102) of the two catheters, as shown in fig. 8B.

In various embodiments, the positioning wire (160a) is then advanced from the right atrium (8) across the tricuspid annulus (3) to the right ventricle (4). According to some embodiments, as shown in fig. 8C, the positioning wire (160a) travels along the axial lumen (122a) of the positioning wire delivery catheter (120) and traverses across the tricuspid annulus (3). When the positioning catheter (100) is proximally retracted, the distal end (162) of the positioning wire (160a) remains within the right ventricle (4). According to other embodiments, as shown in fig. 8D, the positioning wire (160a) travels along one side of the positioning wire delivery catheter (120) or off-center from the axial lumen (122b), and the distal end (162) of the positioning wire (160a) enters the right ventricle (4) as it traverses the tricuspid annulus (3). According to some embodiments, the positioning wire delivery catheter (120) also has a deflectable distal portion (128), the deflectable distal portion (128) allowing the distal portion (128) to deflect radially when the magnet (126) at the distal end (124) of the positioning wire delivery catheter (120) is attracted to the location (32) by the magnet (106) at the distal end (104) of the positioning catheter (100), as shown in fig. 8B. Similarly, the positioning wire delivery catheter (120) may be distally extended and proximally retracted or axially rotated, as indicated by the double-headed arrow. According to some embodiments, the design or construction of the location wire (160a) is similar to that described with respect to fig. 5A and 5B.

Figures 9A and 9B illustrate other embodiments of the present teachings in which the positioning wire delivery catheter (220) is guided by the positioning device (210). According to some embodiments, the positioning wire delivery catheter (220) has two axial lumens (222, 224), one for the positioning wire (260a) and the other for the positioning device (210). The positioning wire delivery catheter (220) enters the right atrium (8) through the lumen (14) of the guide (12). While maintaining the position of the positioning wire delivery catheter (220) within the right atrium (8), the clinician may extend the positioning device (210) distally through an opening among the tricuspid valve (2) leaflets into the right ventricle (4) in a similar manner to the positioning wire delivery catheter (20) described herein with respect to fig. 3A and 3B. Similarly, the positioning device (210) may have a curved distal portion (212) that is preformed or actuated by the clinician, may be extended distally and retracted proximally, or may be axially rotated as indicated by the double-headed arrow in FIG. 9A.

Upon entry into the right ventricle (4), the distal end (214) of the positioning device (210) is located at the first location (32) using the methods described herein with respect to fig. 3A-3B and 8B. Maintaining the position of the positioning device (210), the positioning wire delivery catheter (220) is pushed distally towards the tricuspid ring (3) such that the tricuspid ring (3) is sandwiched between the distal end of the positioning wire delivery catheter (220) and the distal end of the positioning device (210), as shown in fig. 9B. As shown in fig. 9B, the positioning wire (260a) is advanced distally from the positioning wire lumen (224) across the tricuspid annulus (3) and into the right ventricle (4). According to some embodiments, the distal end (214) of the positioning device (210) has an opening or slot. In some embodiments, as the positioning wire (260a) is advanced across the tricuspid annulus (3), it enters an opening or slot in the distal end (214) of the positioning device (210). In other embodiments, the distal end (214) of the positioning device (210) is configured such that the clinician does not interfere with the positioning wire (260a) when the clinician proximally retracts the positioning device (210). According to some embodiments, the design and construction of the location wire (260a) is similar to that described herein with respect to fig. 5A and 5B. Those skilled in the art will appreciate that the specific embodiments in fig. 9A and 9B illustrate only certain aspects of the present teachings and that they are not to be considered limiting of the scope of the present teachings.

According to some embodiments, upon placement of the positioning wire (160, 260) across the first location (32) on the tricuspid annulus, the positioning wire delivery catheter (120, 220), the positioning catheter (100), and/or the positioning device (210) are retracted proximally outside the body. Fig. 10 illustrates various embodiments of a positioning wire (160, 260) extending distally from a venous access location, traveling along the lumen of a positioning wire delivery catheter (120, 220) into the right atrium (8), traversing the tricuspid annulus (3), and reaching the right ventricle (4). The proximal end of the positioning wire (160, 260) remains outside the body and is controlled by the clinician. The distal end (162, 262) of the positioning wire (160, 260) remains within the right ventricle (4). In some embodiments, the positioning wire (160, 260) has a piercing tip that allows it to perforate the tricuspid annulus (3) or a radiofrequency energy delivery tip that delivers radiofrequency energy to the annulus tissue to perforate the tricuspid annulus (3). In addition, similar to that described herein with respect to FIGS. 5A and 5B, the distal portion of the positioning wire is designed to deflect or crimp to prevent accidental tissue damage, as shown in FIG. 10.

In various embodiments, the tissue anchor (310a) is placed at a location by a positioning wire (e.g., 60a, 160a, or 260a in fig. 11-13) that traverses the tricuspid annulus (3). According to some embodiments, as shown in fig. 11-13, the first tissue anchor delivery catheter (300) is advanced along the positioning wire (60a, 160a, 260a) across the tricuspid annulus (3) and into the right ventricle (4). In certain embodiments, a tissue anchor delivery catheter (300) is used to deliver a tissue anchor (310a) to the tricuspid annulus (3).

Fig. 11-12 illustrate exemplary delivery and placement of a first tissue anchor (310a) across the tricuspid annulus (3). Fig. 11A and 12A illustrate the process of exposing the distal end portion (316a) of the tissue anchor (310a), and fig. 11B and 12B illustrate the process of exposing the proximal end portion (318a) of the tissue anchor (310a) according to the embodiment described in fig. 2-9. Fig. 11C and 12C illustrate exemplary placement of tissue anchors (310a) at location (32) according to the embodiments described in connection with fig. 2-9.

Referring to fig. 11A and 12A, in some embodiments, a tissue anchor delivery catheter (300) holding a tissue anchor (310a) within its longitudinal lumen (302) travels along a positioning wire (60a, 160a, 260a), across the tricuspid annulus (3) and into the right ventricle (4). With continued reference to fig. 11A and 12A, in some embodiments, the tissue anchor (310a) is partially pushed distally outside the distal end (304) of the tissue anchor delivery catheter (300). Once the distal portion (316a) of the tissue anchor (310a), or a sufficient number of anchoring elements (316a shown in fig. 11A and 12A), is exposed within the right ventricle (4), the clinician then stops pushing the tissue anchor (310a) distally and retracts the tissue anchor delivery catheter (300) proximally, causing the distal end (304) of the tissue anchor delivery catheter (300) to move proximally across the tricuspid annulus valve (3) and back to the right atrium (8). The clinician then exposes the proximal portion (318a) of the tissue anchor (310a) or the remainder of the anchoring element (312) of the tissue anchor (310a) within the right atrium (8) by further proximally retracting the tissue anchor delivery catheter (300), as shown in fig. 11B and 12B.

As shown in fig. 11C and 12C, in various embodiments, to deploy the tissue anchor (310a), the clinician pulls on the proximal end of the tensioning member (314) such that the anchoring elements (312) of the tissue anchor (310a) are drawn together against opposite sides of the tricuspid annulus (3), thereby securing the first tissue anchor (310a) to the tricuspid annulus (3). As a result, as shown in fig. 11C and 12C, in some embodiments, the first tissue anchor (310a) is deployed across the tricuspid annulus (3) at the first location (32), the distal portion (316) of the tissue anchor (310a) is placed against the ventricular side of the tricuspid annulus (3), the proximal portion (318) of the tissue anchor (310a) is placed against the atrial side of the tricuspid annulus (3), and the tensioning member (314) of the first tissue anchor (310a) extends proximally through the lumen (302) of the tissue anchor delivery catheter (300) out of the body. According to some embodiments, once the distal portion of the tissue anchor delivery catheter traverses the loop, the positioning wire (60a, 160a, 260a) marking the first location (32) is withdrawn proximally and maintaining the loop channel during deployment of the first tissue anchor (310 a). In other embodiments, after deployment of the entire tissue anchor across the loop, the marker first location (32) is withdrawn proximally and the positioning wire (60a, 160a, 260a) of the loop channel is maintained during deployment of the first tissue anchor (310 a). According to some embodiments, the proximal end of the tensioning member (314) is controlled by the clinician outside the body as the tissue anchor is deployed across the loop.

Fig. 13A and 13B illustrate another embodiment of delivering and deploying the distal portion (316a) of the tissue anchor (310a) at the first location (32). Referring to fig. 13A, in some embodiments, a tissue anchor delivery catheter (300) holding a tissue anchor (310a) and a push wire (320) inside its longitudinal lumen (302) is advanced along a positioning wire (not shown) across the tricuspid annulus (3) and into the right ventricle (4). With continued reference to fig. 13A, in some embodiments, the tissue anchor (310a) is partially pushed distally by the push wire (320) away from the distal end (304) of the tissue anchor delivery catheter (300). In this particular embodiment, the tissue anchor (310a) includes a tip (322). And with continued reference to fig. 13A, the clinician stops pushing the tissue anchor (310a) and pulls on the proximal end of the tensioning member (324) attached to the tissue anchor (310 a). As a result, the tip (322) is pulled proximally and helps the tissue anchor (310a) fold upon itself, as shown in fig. 13B. With the distal end portion (316a) of the tissue anchor (310a) in its deployed configuration, the clinician proximally retracts the tissue anchor delivery catheter (300) such that the distal end (304) of the tissue anchor delivery catheter (300) moves proximally across the loop and back to the right atrium, exposing the proximal portion of the tissue anchor (310a), and deploying the proximal portion of the tissue anchor, all similar to that discussed with respect to fig. 11B, 11C, 12B, 12C.

One of ordinary skill in the relevant art will appreciate that the present teachings need not be implemented in the steps and sequences discussed in fig. 11A, 11B, 11C, 12A, 12B, 12C, 13A, and 13B. Indeed, the steps discussed in FIGS. 11A, 11B, 11C, 12A, 12B, 12C, 13A, and 13B may be taken from the order in which they are included and mixed with other orders without affecting the scope of the present teachings. For example, partial placement of the tissue anchor prior to retraction of the tissue anchor delivery catheter to the right atrium, as discussed with respect to fig. 13A and 13B, can be implemented in the various embodiments discussed in fig. 11A-12C.

According to some embodiments of the present teachings, a clinician may deploy a second tissue anchor (310b) at a second location (30) with the first tissue anchor (310a) securely deployed at a first location across the tricuspid annulus (3). Fig. 14-15 illustrate several exemplary placements of a second tissue anchor (310b) across the tricuspid annulus (3) at a second location (30).

According to some embodiments, similar to that described herein, for example in fig. 3-7, the clinician positions the positioning wire delivery catheter (20) against the tricuspid annulus (3) from within the right ventricle (4) at the second location (30) using similar steps. According to some embodiments, positioning of the positioning wire delivery catheter against the tricuspid annulus comprises extending, retracting, rotating, or otherwise manipulating the positioning wire delivery catheter (20) to the second position (30) similar to the methods described herein or those known to those skilled in the art. Similar to that described herein with respect to fig. 3-7, one end of the second positioning wire (60B) is advanced across the tricuspid annulus (3), captured by the capture basket (44, 52) as shown in fig. 4A and 4B, and pulled proximally through the lumen (14) of the guide (12) outside the body. As shown in fig. 14A, this results in the positioning wire (60b) being placed at the second position (30), and both ends of the positioning wire (60b) being located outside the body.

According to an alternative embodiment, similar to that described in fig. 8-10, the clinician takes similar steps to position the positioning wire delivery catheter (120, 220) against the tricuspid annulus (3) from within the right atrium (8) at the second location (30). According to some embodiments, this may be accomplished by extending, retracting, rotating, or otherwise manipulating the positioning catheter (100) or positioning device (210) at the second location (30) similar to the methods described herein or known to those skilled in the art. Similar to that described with respect to fig. 8-10, the positioning wire delivery catheter (120, 220) is positioned at the second location (30) by magnetic attraction or by the positioning wire delivery catheter design discussed herein. As shown in fig. 14B, the second positioning wire (160B, 260B) is advanced distally across the tricuspid annulus (3) and to the right ventricle (4), as described herein. As a result, as shown in fig. 14B, one end of the positioning wire (160B, 260B) extends distally through the lumen (14) of the guide (12) and to the right ventricle (4). In other words, the distal end of the second positioning wire (160b, 260b) is located within the right ventricle (4), and the proximal end of the second positioning wire (160b, 260b) is located outside the body.

In various embodiments, a second tissue anchor (310B) is deployed at the second location (30) according to the various embodiments described herein with reference to fig. 15A-15B. Fig. 15A and 15B illustrate an embodiment of the second tissue anchor (310B) emplaced across the tricuspid annulus (3) at the second location (30), wherein a distal portion (316B) of the second tissue anchor (310B) is positioned against the ventricular side of the tricuspid annulus (3), a proximal portion (318B) of the tissue anchor (310B) is positioned against the atrial side of the tricuspid annulus (3), and the tensioning member (314) of the second tissue anchor (310B) extends proximally through the vein out of the body. At this time, the second positioning wire (60b, 160b, 260b) may be removed.

Fig. 16 shows an exemplary reduction of the tricuspid valve (2). In various embodiments, the reduction is achieved by applying tension to two or more tissue anchors (310a and 310b) in fig. 16. In some embodiments, two or more tissue anchors (1A-1f in fig. 1A and 1B) are connected in series by a single tensioning member (5 in fig. 1A and 1B), which is referred to as a "chain" or "chain". And in these embodiments, the reduction is achieved by applying tension to a single tensioning member (5), the tensioning member (5) further pulling two or more tissue anchors (1a-1f) closer to each other and folding the tissue between each pair of tissue anchors.

According to some embodiments, as shown in fig. 16, the tensioning member (330) connects a first tissue anchor (310a) at a first end of the tensioning member (330) and a second tissue anchor (310b) at a location proximate to the first end of the tensioning member. In some embodiments, the proximal end of the tensioning member (not shown) passes through the guide (12) and is located outside the patient's body. In various embodiments, the clinician applies tension to the proximal end of the tensioning member (314 a). In some embodiments, the tension causes the two tissue anchors (310a and 310b) to be pulled closer to each other, thereby reducing the length of the tensioning member between the tissue anchors (310a, 310b), thereby folding the tissue between the tissue anchors (310a, 310b) and reducing the circumference (3) of the tricuspid annulus. In some embodiments, such tension and reduced distance between the two tissue anchors (310a, 310b) is maintained, for example, by a lock or other locking mechanism. Although fig. 16 shows that after tissue folding between two tissue anchors, the two tissue anchors (310a, 310b) are each connected with a tensioning member and the two tensioning members are locked between the two tissue anchors (310a, 310b) with a lock, one of ordinary skill in the art will appreciate that the tissue anchors can be connected with one tensioning member, one tensioning member can be used to fold the tissue, and the lock is located on one side of the two tissue anchors (i.e., not between the tissue anchors). Suitable locking devices include those well known in the art, and described in U.S. application Ser. No. 11/753,921 entitled "locking device for Surgical tensioning Members and Methods of Using the Same", filed on 25.5.2007, which is incorporated herein by reference. By securing the tensioning members (314a, 314b) by a lock (not shown), excess tensioning members (314a) adjacent to the lock can be removed by a Cutting machine, such as the Cutting machine disclosed in U.S. patent application serial No. 11/935,054 entitled "Suture Cutter and Method of Cutting Suture" filed 11/5, 2007, the disclosure of which is incorporated herein by reference. The guide (12) and all of the positioning wire delivery catheter (20, 120, 220) and/or the tissue anchor delivery catheter (300) can then be proximally retracted and removed.

According to some embodiments, each tissue anchor is deployed sequentially. Specifically, the embodiment described with respect to fig. 2-15 allows a clinician to place a positioning wire (60, 160, 260) at a first location (32) followed by placement of a first tissue anchor (310a), and then place the same positioning wire or a second positioning wire at a second location (30) followed by placement of a second tissue anchor (310 b).

According to other embodiments, two or more location wires are placed simultaneously. In particular, a double-branch catheter (400) may be used to place two location wires at two locations simultaneously. According to other embodiments, catheters having more than two branches may be used to place multiple location wires at multiple locations simultaneously.

Fig. 17-19 illustrate the use of a double-branch catheter (400) to place two location wires (460a, 460b) across the tricuspid annulus (3). According to one embodiment, as shown in fig. 17, the dual-branch catheter (400) includes a first catheter member (402a) having a first lumen (404a) for a first location line (460a) and a second catheter member (402b) having a second lumen (404b) for a second location line (460 b). First and second positioning wires (460a, 460b) are slidably disposed within the first and second catheter lumens (404a, 404b), respectively. There is a predefined lateral distance "L" between the first conduit member (402a) and the second conduit member (402 b).

According to some embodiments, the double branch catheter (400) is delivered to the right ventricle (4) and positioned against the tricuspid annulus (3) by a positioning wire delivery catheter (20), as shown in fig. 3A. According to some embodiments, similar to what is described herein according to fig. 3-7, when the positioning wire delivery catheter (20) is positioned against the tricuspid annulus (3) from within the right ventricle (4), the first positioning wire (460a) extends through the lumen (404a) of the first catheter member (402a), placed across the tricuspid annulus (3). The positioning wire delivery catheter (20) is retracted proximally, exposing the second catheter member (402b) of the dual-branch catheter (400), as shown in fig. 18A. Once beyond the distal end (24) of the positioning wire delivery catheter (20), the second catheter member (402b) expands laterally from the first catheter member (402a) to a predefined distance. Without losing the position of the first positioning line (460a), the clinician can rotate the dual-branch catheter (400) and/or the positioning wire delivery catheter (20) such that the second catheter member (402b) is located at the second position (30). A second positioning wire (460B) is then advanced across the tricuspid annulus (3) according to the steps described herein and shown in fig. 4A-5B.

According to some embodiments, the two locating wires (460a, 460b) are captured by the capture device, and then the distal ends of the two locating wires (460a, 460b) are withdrawn outside the body through the lumen (14) of the guide (12). As a result, as shown in fig. 18B, the two positioning wires are placed at two locations that can be used to facilitate placement of the two tissue anchors (310a), in accordance with the steps discussed above and in accordance with fig. 11A-11C.

According to other embodiments shown in fig. 19A, a dual-branch catheter or device (500) is delivered to the right ventricle (4) through the lumen of the positioning catheter (100). When the distal end (104) of the positioning catheter (100) is positioned against the tricuspid annulus (3), the first catheter member (502a) is placed at the first location (32), attracting the first positioning line delivery catheter (510a) and facilitating placement of the first positioning line (not shown). The positioning catheter (100) is retracted proximally, exposing the second catheter member (502b) of the dual-branch catheter (500), as shown in fig. 19A. Once beyond the distal end (104) of the positioning catheter (100), the second catheter member (502b) expands laterally from the first catheter member (502a) to a predetermined distance. The clinician can rotate the dual-branch catheter (500) and/or the positioning catheter (100) without losing the position of the first positioning line delivery catheter (510a) such that the second catheter member (502b) is located at the second position (30). The second catheter member (502B) attracts the second positioning wire delivery catheter (510B) and facilitates placement of a second positioning wire (not shown) across the tricuspid annulus (3), as shown in fig. 19B.

According to some embodiments, the double-branch catheter is placed at two locations first, and the first and second positioning wires are placed across the tricuspid annulus simultaneously or sequentially. Alternatively, in other embodiments, the first catheter member of the dual-branch catheter is first positioned at a first location, and the first location line is placed across the tricuspid annulus; and a second catheter member of the dual-branch catheter is positioned at a second location and a second positioning wire is placed across the tricuspid annulus.

As a result, as shown in fig. 18B and 19B, two positioning wires are placed at two locations, followed by deployment of two tissue anchors according to the procedure discussed herein and according to fig. 11-16, or a similar procedure.

While an exemplary two-pronged catheter is described above, those of ordinary skill in the art will appreciate that three or more pronged catheters may be used without departing from the spirit of the present teachings. The double or multi-branch catheters described in connection with the drawings of the present teachings are similar to those in the following documents: U.S. patent application Ser. No. 11/685,239 entitled "Systems and Methods for Introducing Elements Into Tissue" filed 3/13 of 2007; U.S. patent application serial No. 11/685,240 entitled "Tissue Anchors, Systems, and Methods, and Devices" filed 3, 13/2007; U.S. patent application Ser. No. 11/685,242 entitled "Devices and Methods For Introducing Elements into Tissue" filed 3/13 of 2007; and U.S. patent application Ser. No. 13/282,139 entitled "Hand Operated Device for Controlled Deployment of a Tissue Anchor and Method of Using the Same" filed on 26.10.2011; the entire contents of each are incorporated herein by reference.

Tissue anchor

Another aspect of the present teachings relates to a tissue anchor that may be used to reduce the circumference of the tricuspid valve (2). In general, any tissue anchoring device known in the art may be used in the methods of the present teachings. In various embodiments, the tissue anchor is collapsible. Referring to fig. 20A, the tissue anchor (310A) includes a plurality of anchor elements (312) coupled with a tensioning member (314). The anchoring element (312) may be made of a surgical grade fabric material (e.g., a polyester material such as DACRON), and in some cases, is designed to promote tissue growth such that the anchor (310a) is at least partially encased in tissue for extended periods of time. The anchor element (312) is coupled to the tension member (314) (in this example, a suture) by threading the suture distally through the anchor element (312) and proximally through the anchor element (312). A sliding knot or other type of locking mechanism is formed such that when the proximal portion of the tensioning member (314) is pulled, all of the anchoring elements (312) will be pulled together. Further, in some embodiments, pulling of the proximal portion of the tensioning member (314) draws the anchoring element at the distal end first, and draws the element at the proximal end later, as discussed elsewhere herein. Thus, in various embodiments, the tissue anchors of the present teachings include an elongated or delivery configuration and a shortened or deployed configuration. In some embodiments, in the deployed configuration, the anchor element is folded and leaves a long "tail" of the tension member, such as a suture exiting the anchor, for example, as shown in fig. 21A-21C. In some embodiments, a long "tail" may be used for subsequent attachment of additional tissue anchors, tensioning, and folding, as described herein.

Fig. 20B-20D show alternative tissue anchoring devices. In various embodiments, an elongate strip (74) activated with a tensioning member (not shown) has proximal and distal end portions (74a, 74 b). The elongate strip 74 includes a tip (76) formed or otherwise secured to the distal portion (74 b). In some embodiments, the tension member and the tip (76) are arranged such that the tension member and the tip (76) can slide relative to each other. In some embodiments, the tensioning member may pass through the tip (76). As shown in fig. 20B-20D, the tip (76) is made relatively rigid compared to the other flexible portions of the elongate strip (74) and has a diameter less than the width of the elongate strip (74). In some embodiments, the tip (76) facilitates penetration of the annulus tissue as the inner tubular member (not shown) and elongate strip (74) extend through the tissue. The push wire of embodiments thereof described herein may be used to push the tip (76) out of the tubular member at a desired time. In various embodiments, the tip (76) may protrude slightly from the inner tubular member when tissue is penetrated to assist in piercing tissue.

In some embodiments, the tip (76) may also assist in forcing the distal portion or half portion (74b) of the elongate strip (74) to fold or otherwise become shortened. To help prevent the distal portion (74B) of the elongate strip from being drawn away from the annulus tissue that has passed as the tissue anchor delivery catheter is withdrawn from the annulus tissue, in some embodiments, the free ends of the tensioning members are pulled while the tissue anchor delivery catheter is still penetrating the tissue and entering the left atrium from the left ventricle, for example, as shown in fig. 21A and 13B. This causes the distal portion (74b) to assume a folded or otherwise shortened configuration. The inner tubular member can then be withdrawn without also withdrawing the elongate flexible elongate strip (74). In various embodiments, the proximal portion (74a) of the elongate strip (74) is then exposed by further pulling the tissue anchor delivery catheter in the proximal direction, thereby exposing the full length of the elongate strip (74). The tensioning member is stretched or tensioned so as to stretch and compress the proximal portion (74a) of the elongate strip (74) into a folded, shortened condition against the underside of the annulus tissue, as shown, for example, in fig. 21B.

As shown in fig. 20B and 20C, a tensioning member or suture (not shown) may advantageously extend through the respective folded portions (74C) of the elongate strip (74) in a substantially hourglass configuration. Specifically, therefore, in some embodiments, adjacent portions of the suture located near the proximal and distal end portions (74a and 74b) of the elongate strip (74) are spaced further apart from adjacent portions of the suture in the middle of the elongate strip (74).

As further shown in fig. 20C, radiopaque markers, such as different areas of dots (95), may be used to enable the surgeon to visualize the folding of the elongate strip (74) during placement and fixation of the elongate strip (74). The dots or other radiopaque markings may be printed on the elongate strip (74). For example, dots (95) or other indicia may be formed with platinum powder based inks or other suitable radiopaque and biocompatible materials. The radiopaque material may also add rigidity to the folded portion (74c), thereby helping to keep the folded portion (74c) flat and increasing the retention force on the tissue. At the same time, the fold lines (74d) between the folded portions (74c) may remain highly flexible to create tight radius fold lines. As further shown in fig. 20B, each hole (96) that receives a tension member or suture (72) may be marked with a circle (98) or other marking around each hole (96) for visualization purposes during assembly of the tension member or suture (72) with the elongated strip (74). Alternatively, the hole (96) may not be used and the suture may be passed through the elongate strip (74) with a needle. For example, different sets of apertures (96) may also be selected along the elongate strip (74) for receiving tensioning members or sutures (72) to vary the width of the folds and/or the number of folds and/or the shape of the folds, depending on the application needs or desires of the surgeon.

The tension members or sutures (314 in fig. 20A) may be threaded or otherwise attached along the elongate strip (74) in any number of ways, including, for example, an x-pattern or other criss-cross pattern, a zig-zag pattern, etc., which may alter the folding or other foreshortening or compression of the anchor into various beneficial shapes, such as a flower, circle or other arc, sphere, or other configuration. Modification of the manner in which the tensioning members or sutures are threaded or otherwise attached along the length of the elongate strip (74) may result in a higher or lower tensioning force being required to compress the anchor and/or a higher or lower frictional holding force may be used to help maintain the anchor in a compressed or shortened configuration.

The width of the elongate strip (74') may vary along its length, such as by tapering, stepping, or forming one or more hourglass shapes along the length of the elongate strip (74). For example, as shown in fig. 20D, proximal and distal portions (75, 77) having wider dimensions along the length of the elongate strip (74') than one or more intermediate or mid-section portions (79) will allow these wider portions (75, 77) to cover more of the intermediate folded portion (79) and prevent unnecessary contact with adjacent tissue during use. It should be understood that throughout the embodiments, like reference numerals are used to refer to like elements, and reference numerals having an original (') or double (") designation refer to like elements that have been modified in the manner described herein, or are shown in the associated drawings.

The elongate strip (74) may have a variable stiffness, including, for example, a relatively rigid perimeter or relatively rigid edges (74e, 74f) (fig. 20B) or spaced relatively rigid portions (not shown) separated by flexible portions (e.g., hinges, not shown), which may assist in folding and securing the elongate strip in a folded state.

Examples of Tissue anchors (310) described in connection with the above figures of the present teachings are somewhat similar to U.S. patent application Ser. No. 12/273,670 entitled "Tissue Anchor and Anchoring System" filed 11/19 2008, 5/7/2005, U.S. patent application Ser. No. 11/174,951 entitled "Tissue Anchor, Anchoring System and Methods of Using the Same", and U.S. patent application Ser. No. 13/777,042 entitled "Tissue Anchor and Anchoring System" filed 2/26 2013, each of which is incorporated herein by reference in its entirety.

Other suitable tissue anchors may also be used. Examples of suitable tissue anchors include, but are not limited to, tissue fasteners, tissue material or tissue staples, and the like.

Fig. 20E and 20F illustrate alternative tissue anchors or fasteners (550) that may be used with the various systems of the present teachings. Such tissue anchors or fasteners (550) may be rigid and coupled to the flexible tensioning member (552) or coupled such that the tissue anchor or fastener (550) slides along the flexible tensioning member (552) as necessary for the fastening system in which the tissue anchor or fastener (550) is being used.

Fig. 20G is a side view of another alternative tissue anchor or fastener (560), which is similar to that shown in fig. 20E and 20F, except that the tissue anchor or fastener (560) has a curved outer configuration. The curved, externally configured convex surface (562) is adapted to engage tissue and cause less damage to the tissue than the flat configuration shown in fig. 20E and 20F.

Fig. 20H-20J illustrate another alternative tissue anchor or fastener (570) that may be used with the various systems and methods of the present teachings. Such a tissue anchor or fastener (570) includes two radially expandable portions (572, 574) that can be delivered through a catheter (576) in the unexpanded state shown in fig. 20H. And then expanded on opposite sides of the tissue (40) to capture the tissue (40) therebetween, as shown in fig. 20I and 29J.

Figure 20K illustrates another alternative tissue anchor (580) that may be used with the various systems and methods of the present teachings. The tissue anchor includes an elongate strip (582) similar to those described in fig. 20A-20D. Elements detailed in fig. 20A-20D may be incorporated into the replacement tissue anchor. For example, tissue anchor (580) may include one or more apertures (586) similar to aperture (96) in fig. 20B and 20C and configured to allow tension members (590 in fig. 20N-20P) to slide through. Alternatively, the flexible tensioning member or suture (590 in fig. 20N-20P) may also be threaded through the elongate strip (582) with a needle. In some embodiments, the tissue anchor (580) includes a band (584). In certain embodiments, the elongated strip (582) and the band (584) are arranged such that the band (584) slides relative to the elongated strip (582). The belt may serve one or more of a number of purposes. For example, the band (584) may include one or more radiopaque markers. Thus, the tissue anchor (580) may be visualized in the delivery and deployment of radiographic imaging devices such as X-ray, magnetic resonance, ultrasound, fluoroscopy, or other imaging techniques. The band (584) may also assist in perforating the annulus, instead of or in addition to the radiopaque marker. Alternatively, or in addition, the band (584) can also assist in transitioning the tissue anchor from the delivery configuration, as shown in fig. 20K and 20L, to the deployed configuration, as shown in fig. 20M.

As for the components of the anchor, the band (584) has multiple cross sections. In various embodiments, the cross-section of the band (584) is cylindrical, rectangular, i-beam, annular, or any other practical shape. Further, the band may be made of a material selected from a variety of materials. In various embodiments, the band is made of a metal, including platinum, titanium, steel, or alloys thereof. In various embodiments, the tape is made of a polymer, including polyester, polypropylene, copolymers thereof, or composites thereof.

The elongated strip (582 in fig. 20K-20P and in other embodiments) may be a sheet, a rope, or other structure. In various embodiments, the elongate strips of the present teachings are made of a polymer, including polyester, polypropylene, copolymers thereof, or composites thereof.

Similar to the description elsewhere in the present teachings, the tensioning members associated with the tissue anchors described herein can be sutures. In various embodiments, the tensioning member is a monofilament, braided structure, wire, or other structure that can be used to connect and tension multiple anchors. Typical tensioning materials include polyester, polypropylene, silk and stainless steel.

Similar to the tissue anchors shown in fig. 20B-20D, in some embodiments the tissue anchor further includes a tip (588), as shown in fig. 20L, having one or more features and/or functions associated with tip (76) in fig. 20B-20D.

Fig. 20M shows the tissue anchor in a deployed configuration of 20K or 20L. Specifically, after the tissue anchor (580) is delivered into position, tension is applied to the tensioning member and the two ends (582a and 582b) of the tissue anchor (580) are folded over each other, as shown in fig. 20M. In various embodiments, at least a portion of the band (584) is located in the right atrium or right ventricle. In some embodiments, the entire band (584) is located in the right atrium. In some embodiments, the entire band (584) is located in the right ventricle. In various embodiments, at least a portion of the elongated strip (582) is located in the right atrium or right ventricle. In some embodiments, at least a portion of the elongated strip (582) is located in the right atrium. In some embodiments, at least a portion of the elongated strip (582) is located in the right ventricle. In various embodiments, at least a portion of the elongate strip (582) is positioned through the tricuspid annulus. Without being bound by any particular theory, the likelihood of and extent of damage to tissue, such as tearing of the passing annulus tissue, may be reduced or eliminated when a portion of the elongate strip (582), such as the

end portions

582a or 582b or 582a and 582b, is positioned across the tricuspid annulus.

Fig. 20N and 20O show two alternative tissue anchors in their deployed configurations. In both tissue anchors, each comprises a band (584), an elongate strip (582), and a tensioning member (590). In both examples, the tension members pass through the elongate strip. When the tissue anchor is in its delivery configuration, the tensioning member relaxes to allow it to maintain its elongated configuration. When the tissue anchor is in its deployed configuration, the tensioning members are tightened to bring the ends of the elongate strip together into the deployed configuration. According to some embodiments, a knot or restraint is incorporated into the tensioning member near one end of the elongate strip and the other end of the elongate strip is allowed to slide freely along the tensioning member. When tension is applied, the knot or constraint pushes one end of the elongate strip toward the other end and causes the tissue anchor to transition into its deployed configuration. Those of ordinary skill in the art will appreciate that other arrangements of tension members are within the scope of the present teachings provided that they perform similar functions in a similar manner to produce a similar result and are practical.

Referring back to fig. 20N and 20O, the difference between the two tissue anchors is with respect to the configuration of the tensioning member (590) of the band (584) and elongate strip (582): in fig. 20N, the tensioning member (590) extends through one end of the elongated strip (582), beyond the belt (584), and through the other end of the elongated strip (582); and in fig. 20O, the tensioning member (590) extends through one end of the elongate strip (582) and through the other end of the elongate strip (582). Thus, when tension is applied to the tissue anchor in fig. 20N by the free end of the tensioning member (590), tension is also applied to the strap (584); and when tension is applied to the tissue anchor in fig. 20O, the tension pulls the elongate strip (582), e.g., so that one or both of the ends of the elongate strip can be pulled through the annulus tissue.

Fig. 20P illustrates another embodiment of a tissue anchor according to the present teachings. A set of two tissue anchors (580 and 580 ') is used that includes placement at a first treatment location, wherein a first end of the tensioning member (590) extends through a first end (582 a') of the first elongate strip (582 '), a first end (582a) of the second elongate strip (582), a second end of the second elongate strip (582), and a second end of the first elongate strip (582'). Further, the first end of the tension member (590) extends from a side of the belt (584) that is in a different position than the second end of the tension member (590) extends and forms a knot around the second end of the tension member (590). Thus, when tension is applied to the second (free) end of the tensioning member, the tissue anchors (580 and 580') are pulled toward each other. Further, both ends of the elongated strip (582) of the tissue anchor (580) may be pulled through the annulus tissue, and the strip (584 ') of tissue anchors (580') may be pressed against the tissue. One of ordinary skill in the art will appreciate that other arrangements and/or uses of the tension members are also within the scope of the present teachings.

Examples of Tissue anchors (580 and 580') described in connection with the above figures of the present teachings are similar to those of U.S. patent application serial No. 12/557,655 entitled "Tissue folding Device and Method for Its Use" filed on 9, 11, 2009, the entire contents of which are incorporated herein by reference.

Indications of tissue

Another aspect of the present teachings relates to folding tissue by using two or more tissue anchors of the present teachings. Fig. 21A-21C illustrate an embodiment of a folding procedure, for example, for reducing the circumference of the tricuspid annulus (40 a). To this end, at least two separate tissue anchors (110) may be placed, fastened, and tensioned using a single tensioning member, such as a suture (103) or other member. This is sometimes referred to as chain folding.

As shown in fig. 21A, the first and second tissue anchors (110) may be placed at spaced apart locations along the tricuspid annulus (40a), respectively. Each tissue anchor (110) includes an elongate strip (114) of flexible material (e.g., fabric or other material as described herein) and a single suture (103) or tensioning member extending through each elongate strip (114). When two tissue anchors (110) are placed through the tissue layer (40) at spaced apart locations, the free ends of the suture (103) or tensioning member are pulled, thereby securely fastening the first tissue anchor (110), as shown in fig. 21A and 21B, and then securely fastening the second tissue anchor (110) to the loop tissue (40 a). Upon further pulling or tensioning of the suture (103), the tissue anchors (110) will be drawn together to fold the tissue (40) therebetween, as shown in fig. 21C. A crimp or other locking member (116) may then be used to lock the desired amount of folding by crimping onto the free end of the suture (103). Excess suture (103) may then be cut to eliminate or reduce the length of the suture tail.

Figures 22A-22B illustrate another embodiment of a folding process of the present teachings, for example for use during annuloplasty of the tricuspid annulus (40 a). As shown in fig. 22A, a first anchor (2802A), which may be a T-bar, has a tail (2806a), such as a suture, and is anchored to the tissue (2804). Typically, the tissue (2804) is tissue of the tricuspid annulus or tissue near the tricuspid valve. A second anchor (2802b) having a tail (2806b) is also anchored into the tissue (2804). Typically, the distance between the second anchor (2802b) and the first anchor (2802a) is a measured distance, i.e., the distance between the second anchor (2802b) and the first anchor (2802a) is predetermined. In one embodiment, a catheter is used to substantially control the distance.

Once the first anchor (2802a) and the second anchor (2802B) are in place, the rod-shaped lock is delivered (2810a) through the tail (2806a, 2806B), as shown in fig. 22B. According to some embodiments, the length of the rod-shaped lock is smaller than the distance between the two implantation positions. Thus, once the rod-shaped lock (2810a) is delivered and secured to the tails of the first and second tissue anchors (2806a, 2806b), the distance between the two tissue anchors is reduced, then effectively creating a first fold (2820). According to some embodiments, a third tissue anchor is implanted at a third treatment site, and then a second rod-shaped lock is delivered and secured to the tails of the second and third tissue anchors, and then a second fold is created. Those skilled in the art will understand by repeating these steps, and then creating a chain fold.

It should be understood that if the tail (2806) is also locked and trimmed, two folds (2820, 2830) of the chain are completed. Alternatively, if more folds are to be added, additional anchors and locks may be appropriately positioned so that the tail (2806c) serves as the "starting point" for the additional folds.

23A-23B illustrate another embodiment of a folding process according to the present teachings. In this embodiment, a tissue anchor (190) in the form of an anchor button (190a) is placed along the loop (40). Although not shown, a catheter is used for delivery and implantation of a series of anchor button traversing rings. As described above, the anchoring button may be implanted into the atrium from the ventricle across the tricuspid annulus, or alternatively, from the atrium into the ventricle. According to some embodiments, the anchor button (190a) is further coupled to a flexible tensioning member (196). During delivery, the flexible tensioning member is slidably disposed within the attachment means, such as an eyelet as shown in fig. 23A-23B. The distal end of the tension member includes a constraining mechanism, including a knot or crimp, that may prevent the first anchor button from sliding. Upon deployment, the tensioning member is pulled from its proximal end. A restraining mechanism at the distal end of the tensioning member applies a force to the first anchor button and reduces the distance between the first and last anchor buttons. By further stopping the relative movement between the last anchoring button and the tensioning member (e.g., by crimping or sliding a knot), the tricuspid annulus is collapsed and its circumference reduced. In some embodiments, the flexible tensioning member is located in the right atrium. In some embodiments, the flexible tensioning member is located in the right ventricle.

24A-24C illustrate another embodiment of a folding process according to the present teachings. In particular, fig. 24A-24B illustrate the placement of tissue anchors (210) on the right atrial side of the tricuspid valve, linked to a fabric or fastener (212) in the form of a tissue-capturing load spreading member below the annulus (40). In this case, the anchors and fasteners (210, 212) are coupled together by a flexible tensioning member (214) or strap. The catheter (216 in fig. 24A) is used to deliver the tissue anchors and fasteners (210, 212) in series along the flexible tensioning member (214) such that the tissue anchors (210) are driven through the tissue and the fasteners (212) are released between each tissue anchor (210). According to some embodiments, the tensioning member is slidably disposed through the tissue anchor and the fastener. According to some embodiments, the tissue anchor and fastener are placed on opposite sides of the annulus tissue. The catheter approaches the loop from one side and traverses the loop and places a tissue anchor on the other side of the tissue. A series of tissue anchors and fasteners (210, 212) are then pulled together using a band or flexible tensioning member (214), as shown in fig. 24B. This shortens the distance between each of the tissue anchor and fastener (210, 212) and the entire structure with elements above and below the loop (40). Tissue becomes trapped between the tissue anchor and the fastener (210, 212), thereby spreading the load over a larger area and reducing the risk of tearing. Similar to fig. 22A-22B, in some embodiments, the tissue anchor (210) is located in the right ventricle. In other embodiments, the tissue anchor (210) is located in the right atrium.

Fig. 24C shows a modified version of the system shown in fig. 24A-24B. The tissue anchor and fastener are fixedly attached to one another. And the fastener further includes an eyelet (220) for passage of the tension member wire therethrough. According to some embodiments, a tensioning member (218) is coupled to an eyelet (220) in each fastener (212'). According to some embodiments, the tensioning member is configured to be tensioned to reduce the circumference of the tricuspid annulus (40). In this embodiment, after the tissue anchors and fasteners are delivered and deployed, the tensioning member (218) is pulled to tighten the various tissue anchors and fasteners (210, 212') and fold the loop (40). Similar to fig. 22A-22B, in some embodiments, the tissue anchor is located in the right ventricle. In other embodiments, the tissue anchor is located in the right atrium.

FIGS. 25A-25C illustrate an alternative embodiment of a folding process according to the present teachings. This embodiment is somewhat similar to that shown in fig. 24A-24B, except that the fastener (212 ") has a pair of holes (222, 224) that are different than the eyelet structures through which the flexible tensioning member (214) or drawstring leads pass.

FIGS. 26A-26E illustrate an alternative embodiment of a folding process according to the present teachings. This embodiment includes a catheter-based system for applying a series of tissue anchors through tissue generally at the tricuspid annulus. As shown in fig. 26A-26D, a tissue anchor (348) is delivered through the lumen of the steerable catheter portion (344) and is coupled to a flexible tensioning member (350) and another tissue anchor (352). The first and second fasteners (348, 352) are placed on the same side of the tissue (40) at spaced apart locations with the flexible tensioning member (350) coupled therebetween. These tissue anchors (348, 352) may be formed substantially as torsion spring members that may have portions that capture and lock against the flexible tensioning member (350) in the deployed position, as shown in fig. 26D. Once the first tissue anchor (348) is deployed as shown in fig. 26A-26C, the flexible tensioning member (350) can be pulled to fold the tissue (40) between the first tissue anchor (348) and the steerable catheter portion (344). At this point, a second tissue anchor (352) is delivered and captured and locked with the flexible tensioning member (350) to lock the length of flexible tensioning member (350) between the two tissue anchors (348, 350), with the tissue fold as shown in fig. 26D. This process may be repeated as necessary to fold additional loop tissue (40) to further reduce the loop, for example, as shown in fig. 26E.

Figures 27A and 27B illustrate another embodiment of a folding process according to the present teachings. In this exemplary procedure, a tissue anchor as shown in fig. 20K-20P is used. Specifically, in some embodiments, after two tissue anchors (580 and 580 ') are placed on the tricuspid valve along the tricuspid annulus, tension is applied to the tensioning members (590 and 590 ') with the result that the distance between the two tissue anchors is reduced and the tissue between the two tissue anchors (580 and 580 ') is folded, as shown in fig. 27B. At this point, a lock or crimp may be applied to the free end of the flexible tensioning member to maintain the fold. Additional tissue anchors may be used to further reduce the loop. Alternatively, the tissue anchors (580 and 580) may be connected to a single flexible tensioning member, similar to those in fig. 21A-21C. By applying tension to the tensioning member, the tissue anchors (580 and 580 ') are drawn together and the tissue between the tissue anchors (580 and 580') is folded.

Although several exemplary chain folds are described herein, those of ordinary skill in the art will appreciate that other devices, including, for example, tissue anchors, fasteners, tensioning members, etc., may be used without departing from the spirit and scope of the present teachings. The chain folding described in connection with the drawings of the present teachings and U.S. patent application serial No. 10/948,923 entitled "Tissue Fastening Systems and Methods Using Magnetic guides" filed 24/9 of 2004, U.S. patent application serial No. 10/689,872 entitled "Method and Apparatus for Performing Catheter-based Annuloplasty Using partial folding" filed 11/6 of 2013; and U.S. patent application Ser. No. 11/174,951 entitled "Tissue Anchor, Anchoring System and Methods of Using the Same", filed on 5.6.2005, is somewhat similar; the entire contents of each are incorporated herein by reference.

Chain tissue anchor delivery system

Another aspect of the present teachings relates to a chain tissue anchor delivery system that can be used to deliver and/or deploy a chain tissue anchor and/or fold tissue as discussed herein. In various embodiments, the delivery system delivers a chain of linked tissue anchors to a series of treatment locations along the tricuspid annulus as discussed herein. An example of such delivery and placement is shown in fig. 13A and 13B. In various embodiments, the chain tissue anchor delivery system delivers two or more tissue anchors to two or more different locations. In some embodiments, the chain tissue anchor delivery system delivers and deploys one, two, three, four, five, six, or more tissue anchors in a sequential manner. Thus, after such delivery, when the tensioning member is pulled or tightened, the two or more tissue anchors are pulled closer together and the tissue between each pair of tissue anchors is folded.

In various embodiments, a chain tissue anchor delivery system as shown in fig. 28A includes an elongate shaft (602) having a distal end portion (604). As one of ordinary skill in the art will appreciate, the elongate shaft (602) extends proximally (to the left in fig. 28A), and when in use, the proximal end of the elongate shaft (602) extends within a catheter lumen, which in some cases extends through the entire catheter and outside of the patient's body. In various embodiments, the clinician controls and manipulates the proximal end (not shown) so that the chain tissue anchor delivery system (600) may extend, withdraw, capture, release, and perform any other function that it possesses. In some embodiments, control and manipulation is by additional mechanisms generally known to those skilled in the art.

In various embodiments, a chain tissue anchor delivery system as shown in fig. 28A includes a tissue anchor holder (606). According to some embodiments, the tissue anchor holder (606) has a fixed end attached to the elongate shaft (602) and a free end. The tissue anchor retainer (606) is configured to deflect at or near its fixed end. The free end of the tissue anchor retainer is distal of the fixed end. Thus, in some embodiments, the tissue anchor retainer (606) has a first configuration in which its free end is held proximate to the body of the elongate shaft (602). In some embodiments, the tissue anchor retainer (606) has a second configuration in which the retainer is deflected radially outward and its free end is radially away from the body of the elongate shaft (602).

According to some embodiments, when the tissue anchor retainer (606) captures the tissue anchor (612), as shown in fig. 28B, it deflects radially, its free end is pushed radially outward by the anchor, and assumes its second configuration. Once the tissue anchor is removed, the tissue anchor retainer (606) assumes its first configuration with its free end returned to its radially inward position, proximate the elongate shaft (602). In the second configuration, for example, the tissue anchor retainer (606) retains the tissue anchor (612) and can be used to deliver the retained tissue anchor to a site, as discussed in detail elsewhere in the present teachings.

According to some embodiments, a tissue anchor holder (606) is positioned along the elongate tissue anchor during chain tissue anchor delivery. To capture the tissue anchor for delivery, according to some embodiments, the clinician first pulls the elongate shaft (602) proximally so that the free end of the tissue anchor holder (606) is slightly proximal to the distal end of the elongate tissue anchor. As the clinician then pushes the elongate shaft (602) distally, the free end of the tissue anchor holder (606) captures the tissue anchor, for example, by capturing the structure of the tissue anchor. To deploy the tissue anchor, the clinician extends an elongate shaft (602) distally, such as across the tricuspid annulus. As the clinician pushes the elongate shaft (602) distally, the distal end of the tissue anchor is pulled out of the delivery catheter. According to some embodiments, the clinician then retracts the elongate shaft (602), e.g., proximally, into the delivery catheter which releases the tissue anchor. The tissue anchor can then be fully deployed, similar to that described above.

According to other embodiments, (602) the elongate shaft is then repositioned such that the tissue anchor retainer (606) is configured to capture another tissue anchor for deployment thereof. Those skilled in the art will appreciate that the above steps can be repeated as many times as necessary to deploy multiple anchors along the loop. According to some embodiments, unlike the embodiments described above in which the tissue anchor is deployed by pushing out the delivery catheter from its proximal end, the chain tissue anchor delivery system facilitates the deployment of the tissue anchor through the loop by pulling on the distal end of the tissue anchor to dislodge the tissue anchor from the delivery catheter.

According to some embodiments, the chain tissue anchor delivery system is configured to deliver the tissue anchor at, on, or across the annulus of the heart valve as described herein. According to some embodiments, the tissue anchor is any one of those shown in fig. 20A-25C. One skilled in the art will appreciate that the chain tissue anchor delivery systems disclosed herein can be used with other tissue anchors that can be delivered by a chain tissue anchor delivery system that pulls on the distal end of the tissue anchor. Accordingly, the embodiments disclosed and described in the present teachings should not be considered limiting.

In various embodiments, the chain tissue anchor delivery system, also shown in fig. 28A, includes one, two, or more markers (608A and 608b) to aid in visualization during percutaneous procedures. In various embodiments, a chain tissue anchor delivery system, also shown in fig. 28A, includes a distal end (610). In some embodiments, the distal end (610) has a non-traumatic tip, as shown in fig. 28A. Thus, in some embodiments, the distal end (610) is configured to facilitate a chain tissue anchor delivery system to perforate tissue or to dilate an existing perforation in tissue without damaging the tissue or surrounding tissue.

Fig. 29A shows a distal portion of an exemplary catheter (700) according to the present teachings. The delivery catheter in fig. 29A extends proximally (e.g., to the left according to the figure), and the proximal end may in many cases extend outside the patient's body. A delivery catheter may be used to deliver and deploy the tissue anchors of the present teachings, as shown in some examples in fig. 11-13. The distal portion of the delivery catheter includes a distal end (702).

In various embodiments, a delivery catheter is used in combination with the chained tissue anchor delivery systems of the present teachings. Fig. 29B shows a cross-sectional view of such a catheter taken along line a-a in fig. 29A. In these particular embodiments, the delivery catheter includes a lumen (704) having a central lumen (706) and four side lumens (708a, 708b, 708c, and 708d), and each of the four side lumens (708a, 708b, 708c, and 708d) is in fluid communication with the central lumen (704). For ease of discussion only, each central lumen and four side lumens have an imaginary center or origin. In various embodiments, the distance between each imaginary center of the four side lumens (708a, 708b, 708c, and 708d) and the imaginary center of the central lumen (706) is the same. In various embodiments, the distance between each imaginary center of the four side lumens (708a, 708b, 708c, and 708d) and the imaginary center of the central lumen (706) is different. In some embodiments, two of the four distances are the same. In some embodiments, three of the four distances are the same. In some embodiments, all four distances are different. In various embodiments, the distance between the virtual center of the side lumen and the central lumen is no greater than the sum of the radii of the two lumens. In some embodiments, the distance is not less than one of the radii.

In some embodiments, the delivery catheter includes additional lumens in addition to lumen (704). Thus, in some embodiments, the central lumen (706) is concentric with the delivery catheter (700). In other embodiments, the central lumen (706) is eccentric relative to the delivery catheter (700).

In some embodiments, a lumen (704) extends through the delivery catheter. In other embodiments, the lumen (702) extends a distance proximally from the distal end (702) of the delivery catheter. In these other embodiments, a second lumen having a different shape, size, or combination thereof is connected to the lumen and continues to extend proximally.

Fig. 29C is a cross-sectional view of the distal end of an exemplary delivery catheter, as shown in fig. 29B. Having tissue anchors (710a, 710B, 710c, and 710d) disposed in a lumen (704) of a catheter and a chain-type tissue anchor delivery system (e.g., 600 as shown in fig. 28A and 28B). Specifically, each tissue anchor (710a, 710b, 710c, and 710d) is disposed within one of the side lumens (708a, 708b, 708c, and 708 d). In various embodiments, the tissue anchors (710a, 710b, 710c, and 710d) are in their elongate delivery configuration. In various embodiments, each of the four tissue anchors (710a, 710b, 710c, and 710d) is connected to a flexible tensioning member. In various embodiments, two of the four tissue anchors (710a, 710b, 710c, and 710d) are connected with the flexible tensioning member, and the two tissue anchors are "linked". In various embodiments, three of the four tissue anchors (710a, 710b, 710c, and 710d) are connected with the flexible tensioning member, and the three tissue anchors are "linked". In various embodiments, all of the four tissue anchors (710a, 710b, 710c, and 710d) are connected to the flexible tensioning member and the four tissue anchors are "linked".

While fig. 29B and 29C show a lumen (704) having four side lumens (708a, 708B, 708C, and 708d), those of ordinary skill in the art will appreciate that, as a practical matter, the lumen (704) of each tissue anchor delivery catheter can be manufactured without undue experimentation to include less than 4 (including 1, 2, or 3) or more than 4 (including 5, 6, 7, 8,9, or 10) side lumens, and thus are within the scope of the present teachings.

Thus, in various embodiments, in preparation, one, two, three, or four tissue anchors (710a, 710b, 710c, and 710d) in a delivery configuration are loaded into respective side lumens (708a, 708b, 708c, and 708 d). In some embodiments, in preparation, a chain tissue anchor delivery system (600) is also loaded into the central lumen (706). In other embodiments, the chain tissue anchor delivery system (600) is loaded after the clinician extends the delivery catheter into position.

In various embodiments, following delivery of the delivery catheter to the first location according to fig. 8B or 9B, the clinician opens the tissue anchor retainer (606) in the chain tissue anchor delivery system (600) and extends the chain tissue anchor delivery system (600) to capture one of the plurality of tissue anchors (710a, for illustration purposes only), as shown in fig. 29C. In various embodiments, the clinician further extends the chain tissue anchor delivery system (600) such that its distal end (610) extends through an aperture in the ring or perforates the tricuspid annulus and seats the tissue anchor, for example, as discussed with respect to fig. 13A and 13B.

After deployment of the first tissue anchor, in various embodiments, the clinician retracts the chain tissue anchor delivery system (600) into the tissue anchor delivery catheter. In various embodiments, the clinician rotates the push wire (600) by 90 ° or 180 ° before or after the chain tissue anchor delivery system (600) is retracted within the catheter. In some embodiments, the rotation is achieved by additional mechanisms known to those skilled in the art. In other embodiments, the tissue anchor delivery catheter and the chain tissue anchor delivery system (600) are configured such that the chain tissue anchor delivery system (600) can be rotated by a clinician rotating the proximal end of the push wire outside of the patient.

In various embodiments, the clinician retracts the chain tissue anchor delivery system (600) to approximately the position of one remaining tissue anchor (710b, for illustrative purposes only). In various embodiments, the clinician extends the chain tissue anchor delivery system (600) distally to capture one of the remaining tissue anchors (710b, for illustration purposes only). In various embodiments, the clinician extends the chain tissue anchor delivery system (600) to a second location with the tissue anchors (710b) captured by the retainer (606). In various embodiments, the clinician delivers the tissue anchor (710B) to the tricuspid annulus at a second location, as discussed with respect to fig. 12A and 12B.

The clinician may repeat the steps of retracting the elongate shaft, capturing the tissue anchors, and delivering and deploying the tissue anchors to secure additional tissue anchors (in this particular embodiment, the third and fourth tissue anchors 710c and 710d) in the tricuspid annulus. In other embodiments where the lumen (704) includes less than or more than four side lumens, the clinician delivers and deploys two, three, five, six, seven, eight, nine, or more tissue anchors by repeating the above steps. In various embodiments, each of the plurality of tissue anchors is connected to a tensioning member. In various embodiments, at least two of the plurality of tissue anchors are connected with the tensioning member. In some embodiments, all of the tissue anchors are connected to the tensioning member. Thus, the clinician may apply tension to the tensioning members to fold the tissue between each pair of tissue anchors and reduce the circumference of the tricuspid valve.

According to various embodiments of the present teachings, radiopaque markers or textured surfaces may be used to make the device visible by using radiographic imaging equipment such as X-ray, magnetic resonance, ultrasound, or other imaging techniques. The markers disclosed herein may be applied to any portion of a guide, catheter, or device disclosed in the present teachings. The radiopaque markers may be sewn, glued, riveted, or otherwise placed and secured to the guide, catheter, and/or device. The radiopaque marker may be made of a material selected from tantalum, tungsten, platinum, iridium, gold, alloys thereof, or other materials known to those of ordinary skill in the art. Radiopaque markers may also be made of cobalt, fluoroelastomer, or another paramagnetic material or another MR visible material known to those of ordinary skill in the art. In addition, contrast media injected into the atria, ventricles or arteries can also be used to confirm the location under fluoroscopy.

Unless defined otherwise, all technical and scientific terms used herein have the same meaning as commonly understood by one of ordinary skill in the art to which this teaching belongs. Methods and materials similar or equivalent to those described herein can be used in the practice of the present teachings. In case of conflict, the specification, including definitions, controls, and the like. In addition, the materials, methods, and examples are illustrative only and not intended to be limiting.

Claims

1. A chained tissue anchor delivery system, comprising:

a delivery catheter;

an elongate shaft having a distal portion, a proximal end of the elongate shaft being extendable within a catheter lumen;

a tissue anchor holder having a fixed end attached to the elongated shaft and a free end; the tissue anchor retainer is configured to deflect at or near its fixed end; the free end is located at the far end of the fixed end; the tissue anchor retainer has a first configuration in which a free end thereof is held adjacent to the body of the elongate shaft; when the tissue anchor retainer captures the tissue anchor, it deflects radially and its free end is pushed radially outward by the anchor; the tissue anchor retainer retains the tissue anchor and can be used to deliver the retained tissue anchor to a site.

2. The chain tissue anchor delivery system of claim 1, wherein the tissue anchor retainer has a second configuration in which the retainer is deflected radially outward and its free end is radially away from the body of the elongated shaft.

3. The chain tissue anchor delivery system of claim 1, wherein the tissue anchor holder is positioned along the elongate tissue anchor during chain tissue anchor delivery.

4. The chain tissue anchor delivery system of claim 1,

it also includes one, two or more markers to aid visualization during the percutaneous procedure.

5. The chain tissue anchor delivery system according to claim 1, further comprising a distal end having a non-traumatic tip; the distal end is configured to facilitate a chain tissue anchor delivery system to perforate tissue or to dilate an existing perforation in tissue without damaging the tissue or surrounding tissue.