ANCHORING METHOD FOR REDUCING CARDIAC VALVE REGURGITATION

Abstract

An anchor for securing medical devices within a patient and/or sealing an opening in a body structure can be deployed via a catheter. The anchor may include a distal plate, and proximal plate, and a bridge portion connecting the plates. The anchor may include a tensioning member which can pull the plates together in order to secure the anchor in place and/or seal the opening in the body structure. A single anchor can be used, or multiple anchors, to secure tethers and other medical devices within a patient.

Claims

1. An anchor device for anchoring into a body structure, the anchor device including a deployed configuration and a delivery configuration, the anchor device comprising: a distal plate portion comprising a distal frame and a distal covering, wherein the distal plate portion has a distal plate expanded configuration wherein the distal frame forms a substantially flat disk, and a distal plate compressed configuration wherein the distal frame forms an elongated shape adapted to be inserted into a sheath of a delivery catheter; a proximal plate portion comprising a proximal frame and a proximal covering, wherein the proximal plate portion has a proximal plate expanded configuration wherein the proximal frame forms a substantially flat disk, and a proximal plate compressed configuration wherein the proximal frame forms an elongated shape adapted to be inserted into a sheath of a delivery catheter; and an elongate bridge portion extending between and connecting the distal plate portion and the proximal plate portion, wherein the elongate bridge portion comprises a bridge compressed configuration and a bridge expanded configuration, wherein in the bridge expanded configuration the elongated bridge portion comprises a substantially tubular covering defining a bridge lumen therethrough; wherein when the anchor device is in the deployed configuration, the distal plate portion is in the distal plate expanded configuration, the proximal plate is in the proximal plate expanded configuration, and the bridge portion is in the bridge expanded configuration.

2. The anchor device of claim 1, wherein the distal frame and the proximal frame each comprise a ring of memory metal.

3. The anchor device of claim 1, wherein the distal frame comprises a distal frame first end, a distal frame second end, and a distal frame ring portion extending between the distal frame first end and the distal frame second end, wherein in the distal plate expanded configuration the distal frame ring portion forms a ring-shaped perimeter.

4. The anchor device of claim 3, wherein the proximal frame comprises a proximal frame first end, a proximal frame second end, and a proximal frame ring portion extending between the proximal frame first end and the proximal frame second end, wherein in the proximal plate expanded configuration the proximal frame ring portion matches in shape and size to the distal frame ring portion in the distal plate expanded configuration.

5. The anchor device of claim 3, wherein in the distal plate expanded configuration the distal frame first end and the distal frame second end overlap each other, and wherein in the distal plate compressed configuration the distal frame ring portion forms an elongated shape with the distal frame first end and the distal frame second end on opposing ends of the elongated shape.

6. The anchor device of claim 3, wherein in the distal plate expanded configuration the distal frame first end and the distal frame second end are positioned adjacent each other without overlapping, and wherein in the distal plate compressed configuration the distal frame ring forms an elongated shape with the distal frame first end and the distal frame second end on opposing ends of the elongated shape.

7. The anchor device of claim 6, wherein the distal frame first end and the distal frame second end each comprise an atraumatic structure adapted to minimize damage to tissue when the atraumatic structure engages tissue.

8. The anchor device of claim 1, wherein the proximal frame and the distal frame are each formed from memory material biased toward the respective expanded configuration.

9. The anchor device of claim 1, wherein the distal covering comprises a distal portion outer channel extending around a perimeter of the distal plate portion, wherein the distal frame passes through the distal portion outer channel, and wherein the proximal covering comprises a proximal plate outer channel extending around a perimeter of the proximal plate portion, wherein the proximal frame passes through the proximal plate outer channel.

10. The anchor device of claim 9, wherein the distal covering comprises a distal portion inner channel extending around the distal covering adjacent the bridge lumen, and wherein the proximal covering comprises a proximal plate inner channel extending around the proximal covering adjacent the bridge lumen, the anchor device further comprising a tensioning line passing through the distal plate inner channel and the proximal plate inner channel.

11. The anchor device of claim 10, wherein in the distal plate expanded configuration the distal covering comprises a series of wedge-shaped portions extending inwardly from the distal frame, wherein each wedge-shaped portion comprises a loop, and the loops of adjacent wedge-shaped portions align to form the distal portion inner channel.

12. The anchor device of claim 10, wherein the tensioning line comprises a line distal end secured to the proximal plate portion, the tensioning line passing from the line distal end, then through the proximal plate inner channel, then through the bridge lumen, then through the distal plate inner channel, then back through the bridge lumen.

13. A system for treating body tissue, comprising: an anchor device including a deployed configuration and a delivery configuration, the anchor device comprising: a distal plate portion comprising a distal frame and a distal covering, wherein the distal plate portion has a distal plate expanded configuration wherein the distal frame forms a substantially flat disk, and a distal plate compressed configuration wherein the distal frame forms an elongated shape adapted to be inserted into a sheath of a delivery catheter; a proximal plate portion comprising a proximal frame and a proximal covering, wherein the proximal plate portion has a proximal plate expanded configuration wherein the proximal frame forms a substantially flat disk, and a proximal plate compressed configuration wherein the proximal frame forms an elongated shape adapted to be inserted into a sheath of a delivery catheter; and a bridge portion extending between and connecting the distal plate portion and the proximal plate portion, wherein the bridge portion comprises a bridge compressed configuration and a bridge expanded configuration, wherein in the bridge expanded configuration the bridge portion comprises a substantially tubular covering defining a bridge lumen therethrough; wherein when the anchor device is in the deployed configuration, the distal plate portion is in the distal plate expanded configuration, the proximal plate portion is in the proximal plate expanded configuration, and the bridge portion is in the bridge expanded configuration; and a delivery catheter comprising: a catheter distal portion adapted to receive and releasably hold the anchor device in the delivery configuration; a catheter proximal portion comprising a control handle having one or more controls thereon; and an elongated body portion extending between the catheter distal portion and the catheter proximal portion.

14. The system of claim 13, wherein the catheter distal portion comprises an expansion balloon adapted to radially expand at least a portion of the anchor device.

15. The system of claim 13, wherein the anchor device is self-expanding, wherein the catheter distal portion comprises a sheath adapted to slidingly receive the anchor device therein in the delivery configuration.

16. The system of claim 15, wherein the distal frame comprises a distal frame first end, a distal frame second end, and a distal frame ring portion extending between the distal frame first end and the distal frame second end, wherein in the distal plate expanded configuration the distal frame ring portion forms a ring-shaped perimeter, and wherein the anchor device is secured within the sheath with the distal frame first end distal of the distal frame ring portion, and with the distal frame second end proximal of the distal frame ring portion.

17. The system of claim 16, wherein the proximal frame comprises a proximal frame first end, a proximal frame second end, and a proximal frame ring portion extending between the proximal frame first end and the proximal frame second end, wherein in the proximal plate expanded configuration the proximal frame ring portion forms a ring-shaped perimeter, and wherein the anchor device is secured within the sheath with the proximal frame first end distal of the proximal frame ring portion, and with the proximal frame second end proximal of the proximal frame ring portion.

18. The system of claim 17, wherein the anchor device is secured within the sheath with the distal plate portion distal of the bridge portion, and with the proximal plate portion proximal of the bridge portion.

19. The system of claim 17, wherein the catheter is adapted to advance the anchor device out of the sheath with the distal frame first end advancing out of the sheath first, followed by the distal frame second end, followed by the bridge portion, followed by the proximal frame first end, followed by the proximal frame second end.

20. The system of claim 13, further comprising a tensioning line passing through the anchor device and adapted to pull the distal plate portion toward the proximal plate portion, wherein the tensioning line comprises a line distal end secured to the anchor device, the tensioning line further comprising a proximal line portion extending from the anchor device to the control handle, wherein the proximal line portion is adapted to be pulled by a user to selectively pull the distal plate portion toward the proximal plate portion.

21. The system of claim 20, wherein the wherein the distal covering comprises a distal portion inner channel extending around the distal covering adjacent the bridge lumen, and wherein the proximal covering comprises a proximal plate inner channel extending around the proximal covering adjacent the bridge lumen, wherein the tensioning line extends from the line distal end, then through the proximal plate inner channel, then through the bridge lumen, then through the distal plate inner channel, then back through the bridge lumen, then to the control handle.

22. A method of securing an anchor device to a body structure in a patient, comprising: providing a system comprising a delivery catheter having a catheter distal end with an anchor device secured thereto, wherein the anchor device comprises: a distal plate portion comprising a distal frame and a distal covering, wherein the distal plate portion has a distal plate expanded configuration wherein the distal frame forms a substantially flat disk, and a distal plate compressed configuration wherein the distal frame forms an elongated shape adapted to be secured to a delivery catheter; a proximal plate portion comprising a proximal frame and a proximal covering, wherein the proximal plate portion has a proximal plate expanded configuration wherein the proximal frame forms a substantially flat disk, and a proximal plate compressed configuration wherein the proximal frame forms an elongated shape adapted to be secured to a delivery catheter; and a bridge portion extending between and connecting the distal plate portion and the proximal plate portion, wherein the bridge portion comprises a bridge compressed configuration and a bridge expanded configuration, wherein in the bridge expanded configuration the bridge portion comprises a substantially tubular covering defining a bridge lumen therethrough; advancing the catheter distal end with the anchor device secured thereto to a desired treatment site; and deploying the anchor device at the desired treatment site such that the distal plate portion is in the distal plate expanded configuration and is positioned on a distal side of the body structure, the bridge portion passes through a hole extending through the body structure, and the proximal plate portion is in the proximal plate expanded configuration and is positioned on a proximal side of the body structure.

23. The method of claim 22, wherein after deployment of the anchor device at the desired treatment site, the body structure is compressed between the distal plate portion and the proximal plate portion.

24. The method of claim 23, wherein after deployment of the anchor device at the desired treatment site, the hole extending through the body structure is sealed by the anchor device such that fluid flow through the hole is prevented.

25. The method of claim 22, and further comprising securing a medical implant to the anchor device.

26. The method of claim 25, wherein the medical implant is adapted to modify performance of a body organ.

27. The method of claim 26, wherein the body organ is a human heart.

28. The method of claim 27, wherein advancing the catheter distal end to the treatment site comprises advancing the delivery catheter distal end through a femoral artery and through an aorta.

29. The method of claim 25, wherein the medical implant comprises a tether adapted to be secured to the anchor device.

30. The method of claim 25, wherein the medical implant is secured to the anchor device after deployment of the anchor device at the desired treatment site.

31. The method of claim 22, wherein deploying the anchor device at the desired treatment site comprises expanding the distal plate portion to the distal plate expanded configuration in a position on the distal side of the body structure, followed by expanding the proximal plate portion to the proximal plate expanded configuration in a position on the proximal side of the body structure.

32. The method of claim 31, wherein the system further comprises a tensioning line extending through the anchor device and adapted to pull the distal plate portion toward the proximal plate portion, the method further comprising: after expanding the proximal plate portion to the proximal plate expanded configuration in a position on the proximal side of the body structure, applying tension to the tensioning line to draw the distal plate portion toward the proximal plate portion.

33. The method of claim 22, wherein the distal frame and the proximal frame are self-expanding, and the catheter further comprises a sheath in which the anchor device is slidingly positioned in the delivery configuration, wherein deploying the anchor device comprises slidingly advancing the anchor device out of the sheath.

Description

BRIEF DESCRIPTION OF THE DRAWINGS

[0033] FIG. 1 is a front cross-sectional view of a human heart illustrating orientations of exemplary mitral valve tethers according to an embodiment of the invention;

[0034] FIGS. 2A-2B depict front and side views of an anchor according to an embodiment of the invention;

[0035] FIG. 3 depicts a side view of an anchor deployed in a heart wall according to an embodiment of the invention;

[0036] FIGS. 4A-4C depict perspective, side, and end views of an anchor frame according to an embodiment of the invention;

[0037] FIG. 4D depicts a side view of an anchor frame according to an embodiment of the invention;

[0038] FIG. 4E depicts an end view of an anchor frame according to an embodiment of the invention;

[0039] FIG. 5A depicts a plan view of an anchor covering pattern according to an embodiment of the invention;

[0040] FIG. 5B depicts a plan view of the anchor covering pattern of FIG. 5A in a folded configuration according to an embodiment of the invention;

[0041] FIGS. 6A-6B depict front and perspective views of an anchor according to an embodiment of the invention;

[0042] FIG. 7 is a front view of a device being released from a catheter according to an embodiment of the invention; and

[0043] FIGS. 8A-8C depict front views in partial cross-section of a system of the invention deploying an anchor in a heart wall.

DETAILED DESCRIPTION OF SEVERAL EMBODIMENTS

[0044] FIG. 1 illustrate apparatuses 10a, 10b of the invention placed within a human heart 12 at various deployment configurations/positions. Depending on the particular deployment, apparatuses of the invention such as apparatuses 10a, 10b may serve to lessen myocardial muscular stresses and/or treat leaflet apposition of a heart valve, such as a mitral valve 14, as discussed herein. For example, an apparatus 10a, 10b of the invention may be used to reshape the left ventricle 16 and/or right ventricle 18 of the heart 12, depending on the deployment (e.g., orientation) and other characteristics of the apparatus 10a. Apparatus 10b may be similar to apparatus 10a or different in characteristics such as dimensions, deployment positions, etc.

[0045] As depicted in FIG. 1, apparatus 10a has a tether 20a connecting anchors 22a, 24a. The anchors 22a, 24a are positioned in opposing side walls 26 of the heart 10. Apparatus 10b has a tether 20b with anchors 22b, 24b, but with anchor 22b in a side wall 26 of the heart 12 and anchor 24b inside the septum 28 of the heart 12.

[0046] The exact placement and orientation of apparatuses of the invention may vary, and the placements and orientations shown in FIG. 1 are non-limiting examples. Also, a single apparatus may be used by itself in a heart, or more than one apparatus could be used simultaneously, such as at different locations within the heart for variations on the treatment.

[0047] An exemplary anchor 30 of the invention is depicted in FIGS. 2A-2C, with the anchor 30 having a distal plate 32 and a proximal plate 34, with a bridge 36 connecting the plates 32, 34. The bridge 36 may define a bridge lumen 38 passing therethrough. The dimensions of anchors according to embodiments of the invention may vary depending on the particular application. For example, distal and proximal plates 32, 34 may have deployed diameters 42a, 42b between 0.8 and 1.4 cm, 1 and 1.25 cm, or about 1.13 cm, thus providing anchor tissue-engaging surface areas of between 2 and 6 cm.sup.2, between 3 and 5 cm.sup.2, or of 4 cm.sup.2. The distal and proximal plates of a particular anchor may have equal diameters, or may be of different sizes. For example, one plate may be larger in diameter than the other by 5-10%, 10-15%, 15-20%, 20-25%, or more than 25%, such as where one plate is deployed on the exterior surface of a body structure and the other plate is deployed on the interior surface. The plates may preferably have minimal thicknesses, such as thicknesses 44a, 44b between 0.2 and 2 mm. A bridge may have a deployed length which matches or approximates the thickness of the body structure in which the anchor is deployed. The bridge deployed diameter may be small or relatively large, such as where the bridge is used to seal an opening in the body structure. Note that bridge lengths and diameters of the invention are variable depending on the particular anatomical structures involved, as well as the size of the puncture/delivery hole made by the delivery apparatuses. For example, a bridge which passes through the myocardium and also through the pericardium will be much longer that a bridge which passes only through the myocardium. Examples of bridge deployed lengths 46 are between 1 mm and 2 cm. For myocardial applications, the bridge deployed length may be from 2 to 10 mm, or from 4 to 8 mm. Bridge deployed diameters 48 may be between 1 mm and 10 mm. Note the bridge lengths and diameters of the invention are not limited to these particular values, and may be smaller or larger than these values/ranges.

[0048] As depicted in FIG. 3, the anchor 30 can be deployed within a body structure 50 (such as a heart wall), with the distal plate 32 positioned on a first side 52 of the body structure 50 and the proximal plate 34 positioned on a second side 54 of the body structure 50, and with the bridge 36 passing through an opening 56 in the body structure 50. The opening 56 and bridge 36 extend through the thickness 58 of the body structure 50.

[0049] Anchors such as those disclosed herein may be used in dual- or other multi-anchor apparatuses, such as the tethering systems depicted in FIG. 1. Examples of such apparatuses, and their uses/methods/systems, are depicted and described in U.S. Pat. No. 7,766,812 to Schroder et al. and U.S. Patent Publication No. 2017/0135817 to Tylis et al., the entire contents of each of which are hereby incorporated by reference. Such anchors can also be used in single anchor assemblies, including where a single anchor is used to secure a first end of a tether to a body structure, but with the other end of the tether secured to a non-anchor element positioned within a patient's anatomy. Examples of such apparatuses, and their uses/methods/systems, are depicted and described in U.S. Pat. No. 8,029,556 to Rowe.

[0050] Anchors of the invention may have frames to hold their desired deployed shapes. Such frames may have a delivery configuration (which may be elongated but narrow, such as where an anchor is delivered from a catheter), and may be expandable (e.g., via balloon and/or via self-expansion) to the deployed configuration.

[0051] An example of an anchor frame 60, which may be incorporated into an anchor of the invention. The anchor frame 60 may be self-expanding to the desired deployment shape, which may be the circular shape depicted. The anchor frame 60 comprises a ring 62 having ends 64 which meet at a break 66. As will be appreciated, the break 66 facilitates expanding/reshaping the anchor frame 60 into a low-profile configuration and/or straightened configuration suitable for loading the frame 60 into the lumen of a delivery catheter. The ring 62 may comprise or consist of a shape memory material (e.g., nitinol or another shape memory alloy) suitable for returning the frame 60 from the low-profile configuration (e.g., straightened configuration) to the circular configuration shown in FIGS. 4A-4C. It is contemplated, however, that various other suitably shape memory or elastic materials may be used for the ring 62 without limitation, and without deviating beyond the spirit and scope of the present disclosure. In one embodiment, the frame 60 may be formed of stainless steel. Frame 60 may be of different sizes, diameters, and shapes. Similarly, the ring 62 may be of different sizes, diameters, and shapes, including in the cross-sectional size/shape of the ring 62. Optionally, the ring 62 in cross-section may be circular, oval, ovoid, flower shaped, star shaped, square, rectangular, pentagonal, hexagonal, decagonal, spiral, helical, and/or other shapes. Also, while frame 60 is shown having a circular ring-like shape, other cross-sectional shapes are possible, e.g., oval, ovoid, triangular, square, rectangular, pentagonal, hexagonal, decagonal, etc.

[0052] The atraumatic ends 64 prevent the ends of the frame 60 from otherwise damaging the delivery catheter or the tissues of the heart or other body structures during delivery and deployment of the anchor. Further, the atraumatic ends 64 may facilitate loading of the anchor into/onto a delivery catheter. In the particular embodiment depicted in FIGS. 4A-4C, the atraumatic ends 64 comprise spherical portions or balls at the ends of the ring 62. In one embodiment, the atraumatic ends 64 may be comprised of any of various other suitably shaped portions as may be deemed appropriate; for example, other shapes/configurations for the atraumatic ends 64 is also possible, e.g., cube-shaped, ovoid shaped, oval shaped, etc. In one embodiment, the atraumatic ends 64 comprise portions of the ends of the ring 62 that are formed into spherical, generally spherical, ellipsoid, and/or ovoid portions. In one embodiment, the atraumatic ends 64 may be comprised of separate components that are fastened onto the ends of the ring 62. As will be appreciated, any of various techniques may be used to fasten the atraumatic ends 64 onto the ends of the ring 62 without limitation, including where the atraumatic ends 64 are formed as a single unitary structure (e.g., molded as a single piece) with the ring 62 to create the frame 60. Note that one or both ends of a frame may incorporate such atraumatic structures, and the atraumatic structures may be different at each end of the same frame. For example, the distal end as deployed from a delivery catheter may have one type of atraumatic end structure, and the proximal end as deployed from a delivery catheter may have a different kind of end structure.

[0053] Frames of the invention may be formed using various techniques. For example, frames may be formed from wires bent or otherwise formed into a desired shape, or created using molding techniques. Frames may also be cut from tubes, such as metal tubes (e.g., stainless steel or nitinol tubes). Memory materials may be biased toward a desired expanded/deployed shape using known techniques.

[0054] Ends may overlap, as depicted in FIGS. 4D-4E, which may improve the strength of the frame and/or improve the holding power of an anchor which incorporates the frame. For example, as shown in FIG. 4D, ends 64a of a frame 60a may overlap each other, with the ends 64a stacked upon each other in a direction perpendicular to the plane roughly defined by the frame 64a. Similarly, as depicted in FIG. 4E, ends 64b of a frame 60b may overlap each other, with the ends 64b displaced radially inward and outward so as to overlap each other while still remaining in the plane defined by the frame 64b. In the overlapping embodiments, it may be preferable for the overlapping ends to tightly overlap, with minimal or no spacing between the overlapping ends. The amount over overlap depends on the particular application. The overlapping portion may account for a substantial portion of the perimeter of the frame. The overlapping portion may account for 5% or more, 15% or more, 25% or more, 5-30%, or 10-25% of the perimeter of the frame. One (e.g., the distal end as deployed from a delivery catheter) or both of the overlapping ends may have atraumatic structures, such as the atraumatic ends discussed and depicted with respect to FIGS. 4A-4C above. Also, the atraumatic structures of the frame may be the same, or may be different from one end to the other. It is also contemplated that a frame can form a continuous uninterrupted loop, such as where the ends are firmly connected together (e.g., via welding, glue, etc.) or where the frame is formed as a unitary body. Such an uninterrupted loop embodiment would require somewhat different delivery options, such as where the loop is folded/elongated for positioning into the distal end of a catheter for delivery, and for deployment is pushed out of the catheter or otherwise released, at which point the loop would spring into its more circular deployed form.

[0055] FIGS. 5A-5B depict a strip 70 which can form a cover 72 which may be incorporated with a frame such as the frame 60 in FIGS. 4A-4C to form an anchor according to an embodiment of the invention. FIG. 5A illustrates the strip 70 in an open, unfolded configuration. The strip 70 has two plate sections 74a, 74b connected by a bridge section 76. Each plate section 74a, 74b has opposing straight edges 78 and a series of cutouts 80. The bridge section has opposing straight edges 82. The particular strip 70 depicted is symmetrical about its midline 84.

[0056] As shown in FIG. 5B, the strip 70 can be folded over its midline 84 to form a series of triangular or wedge-shaped portions 86 that work together to fill the center of the anchor, e.g., in pie-shaped slices, when the cover 72 is secured to a frame. The triangular or wedge-shaped portions 86 can help prevent excessive material in the center of the anchor and, thus, help prevent excessive folding or bunching of the material when in the anchor's fully deployed configuration. This may also help the anchor and cover assume a more flattened configuration. Other shapes and designs for the cover are also possible. For example, the cover may have a larger, unbroken surface area (e.g., cover 72 may not have as many tabs, triangular or wedge-shaped portions, or spaces as the embodiment depicted). The strip 70 may be constructed of a thick material or a thin material, and may be configured to form a cover 72 which fills all or a portion of the center of the anchor. The material comprising the strip 70 may be formed of one or more of any of various polymer materials, such as polyethylene terephthalate (PET), ultra-high-molecular-weight polyethylene (UHMWPE), and/or other similar material. In one embodiment, the strip 70 may comprise one or more of any of a wide variety of suitable metallic materials. In one embodiment, the strip 70 may comprise a non-metallic material, such as by way of non-limiting example, carbon fibers and the like. Various combinations of the above materials may also be used.

[0057] As illustrated in FIGS. 5B, portions of the strip 70 may be folded and secured such that passages 88 and/or loops 90 are formed through which a frame (such as that depicted in FIGS. 4A-4C) or a tension member may be threaded to form the anchor. For example, the opposing straight edges 78 of the plate sections 74a, 74b may be folded onto (e.g., to overlap) each other, with the opposing and now overlapping straight edges 78 secured to each (e.g., via sewing, adhesive, etc.) to form a passage 88 extending along the length of the overlapping straight edge 78. The passage 88 can accommodate a frame such as that depicted in FIGS. 4A-4C. The passage 88 is defined at its outer edge by the border of the overlapped straight edges (e.g., by the line defined by the sewing or adhesive or other securement which holds the overlapped straight edges together). The passage 88 may be defined at its inner edge by a second line of thread 92 sewn through the overlapped strip 70 (or a line of adhesive along the strip, etc.). Similarly, on the opposing side 94 (i.e., the side with the wedge-shaped portions 86) are a plurality of loops 90 positioned at the ends of the wedge-shaped portions. The loops 90 may be adapted to receive a tensioning member, such as one or more lines of suture, therethrough. The loops 90 may be defined at one end by the fold along the strip midline 84, and at the other end by lines of thread 96 sewn through the strip 70 (or a line of adhesive along the strip, etc.) but spaced slightly away from the fold along the strip midline 84

[0058] When the strip 70 is in the folded shape of FIG. 5B, one or more lines of thread 98 (or adhesive, etc.) may be sewn or otherwise applied to the bridge section 76 along the overlapping straight edges 82 of the bridge section 76 in order to form a continuous passage which will define the bridge of the anchor.

[0059] The passage 88 is adapted to receive a frame, and the loops 90 are adapted to receive one or more tension members (e.g., one or more lines of suture). Optionally, a similar cover, similar strips, or portions/segments of a cover could be formed from double-lumen cloth (e.g., that may come with a small lumen/passage on one end and a larger lumen/passage on the other end), or from tube-shaped cloth. If tube-shaped cloth is used, it could be flattened with sutures but leave lumens/passages on the ends and could result in the same or a similar shape.

[0060] The self-expandable anchor 100 may be formed by mounting the cover 72 onto the frame 60 by way of threading the frames 60 through each of the passages 88, and by threading or weaving the tension member 102 through one or more or all of the loops 90 of each frame 60 and also through the bridge 106 (such as through the bridge lumen 112). The tension member 102 may optionally be tied to itself in a slip knot or similar adjustable knot that allows the tension member to cinch the loops 90 toward the center of each frame 60. Optionally, as depicted in FIG. 6B, a distal end 108 of the tensioning member 102 is secured to a proximal cover portion 114b, passes through the corresponding loops 90 of that proximal cover portion 114b, then passes through the bridge lumen 112, through the corresponding loops 90 of the distal cover portion 114a, and back out through the bridge lumen 112 such that a proximal end 110 of the tensioning element 102 is at a position proximal of proximal cover portion 114b. For example, after passing through the loops 90 and bridge lumen 112, the proximal end of the tension member 102 may extend to a proximal end of a delivery catheter so that pulling at the proximal end 110 may cinch the loops 90 toward the center of each plate portion 104a, 104b (and also to the center of each cover portion 114a, 114b). Pulling on the tensioning member 102 will also draw the plate portions 104a, 104b together, thus compressing the plate portions 104a, 104b against any intervening tissue structures (such as a heart wall).

[0061] As will be appreciated, upon loosening the tension member 102 within the loops 90, the frames 60 may be more easily transitioned from a deployed or expanded configuration (e.g., a circular or ring-shaped configuration) into a low profile configuration (e.g., straightened configuration), as discussed above, and thus enables the anchor 100 to be suitably loaded into the lumen of (or otherwise secured to) a delivery catheter.

[0062] It should be recognized that anchors according to the invention need not be limited to the frames and covers of FIGS. 4A-6B, but rather various other configurations of anchors are contemplated within the scope and spirit of the present disclosure.

[0063] FIG. 7 depicts a system 120 of the invention having an anchor 100 secured to a catheter 122. An anchor plate portion 104 of the anchor 100 is being deployed from a delivery catheter 122. In the particular embodiment depicted, the anchor plate portion 104 was stored in the catheter 122 in a delivery configuration, which may be an elongated/straightened configuration. A first atraumatic end 64 is advanced out of the catheter distal end 124. As the rest of the anchor portion 104 is advanced out of the catheter 122, the frame 60 transitions its deployed (e.g., circular) shape. Tensioning on the tensioning element 102 will pull the wedge-shaped portions 86 toward the center of the anchor plate portion 104. Note that the delivery catheter 122 may be elongated and flexible so as to follow the turns of internal blood vessels, such as femoral arteries and the aorta.

[0064] FIGS. 8A-8C depict details of device delivery according to an embodiment of the invention. The system 120 is shown with the catheter distal end 124 and anchor 100 advanced into a patient to a desired treatment site, which in the embodiment depicted is a heart wall 130 with a passage 132 therethrough. With the anchor 100 positioned with the restrained distal plate portion 104a on a distal side of the heart wall 130, the catheter sheath 134 is retracted to expose the distal plate portion 104a and permits expansion thereof, as depicted in FIG. 8B. Retraction of the sheath 134 may be accomplished by a user's activation of controls 136 positioned on the catheter handle 138 at the catheter proximal end 140, which may be positioned outside of the patient during the procedure for easy access by a surgeon or other user. The catheter 122 may include an internal rod 142 or other structure which prevents the anchor 100 from retracting as the sheath 134 is withdrawn. Alternatively, instead of retracting the sheath 134, the rod 142 can be advanced distally, thereby pushing the anchor portions out of the sheath 134. In either case, it is retraction of the sheath 134 with respect to the inner rod 142 which releases the anchor 100 from the sheath 134

[0065] Note that the catheter 122 may include a radially expandable balloon 144 or other expansion mechanism for deploying one or more portions of the anchor 100. Such a balloon 144 may be used to expand a non-memory (non-self-expanding) anchor portion (such as one with a frame portion made from stainless steel), and/or to enhance/facilitate the expansion of a self-expanding anchor portion (such as one with a frame portion made from a memory material such as Nitinol).

[0066] Further retraction of the sheath 134 release the entire anchor 100, as depicted in FIG. 8C. At this point, the bridge portion 106 as well as the distal and proximal plate portions 104a, 104b are released and expanded. The tensioning element 102 trails from the anchor 100 and into the delivery catheter 122. Applying tension to the tensioning element 102 will draw the distal and proximal plate portions 104a, 104b together to seat the anchor in the heart wall 130, and may also pull the cover portions of each plate portion 104a, 104b toward the center of the respective plate portion 104a, 104b. As the distal and proximal plate portions 104a, 104b are drawn together, the bridge portion 106 may radially expand, which can improve the sealing ability of the anchor 100.

[0067] With the anchor 100 properly positioned and with the tensioning element properly tensioned, the tensioning element 102 can be tied off (e.g., knotted to the anchor by the user) and excess proximal portions of the tensioning element can be removed (i.e., those tensioning element portions which are proximal to the user-applied knot). The catheter 122 can be removed from the patient, and one or more or all openings through which the catheter had been advanced to the heart wall may be closed (such as via suturing).

[0068] The deployed anchor can be used to secure one or more tethering and/or other elements (which may be secured to the anchor prior to anchor deployment, during anchor deployment, and/or after anchor deployment). Additionally or alternatively, the anchor can be used to seal the opening in the body structure, such as sealing a hole in a heart wall to prevent the leakage of blood therethrough.

[0069] Devices of the invention may include other features to assist in deployment and operation of the devices. For example, radiopaque markers may be included at various locations along devices according to the invention. Active features may be included, such as electrical features.

[0070] Various approaches for treatments, including advancing the catheters into position via the sheath, are within the scope of the invention. In one example of a procedure to treat a blood vessel according to the invention, artery access is obtained such as via an access sheath dimensioned for use in such procedures. An incision is created in the patient, leading to an internal blood vessel such as a femoral artery. The distal end of the access sheath is advanced through the incision and internal blood vessel and into through the desired tissue structure such as a heart wall, with the catheter handle positioned outside the patient adjacent the incision/access site. Echo and/or fluoroscopic and/or other visualization techniques may be used to confirm proper position of the device. The treatment and/or implant deployment can occur, such as by deploying the stent at the target location. Once the proper deployment is confirmed, the catheter can be removed from the patient, and the incision(s) closed, such as via sutures.

[0071] Note that each element of each embodiment and its respective elements disclosed herein can be used with any other embodiment and its respective elements disclosed herein.

[0072] All dimensions listed are by way of example, and devices according to the invention may have dimensions outside those specific values and ranges. The dimensions and shape of the device and its elements depend on the particular application.

[0073] Unless otherwise noted, 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 disclosure belongs. In order to facilitate review of the various embodiments of the disclosure, the following explanation of terms is provided:

[0074] The singular terms “a”, “an”, and “the” include plural referents unless context clearly indicates otherwise. The term “or” refers to a single element of stated alternative elements or a combination of two or more elements, unless context clearly indicates otherwise.

[0075] The term “includes” means “comprises.” For example, a device that includes or comprises A and B contains A and B, but may optionally contain C or other components other than A and B. Moreover, a device that includes or comprises A or B may contain A or B or A and B, and optionally one or more other components, such as C.

[0076] The term “subject” refers to both human and other animal subjects. In certain embodiments, the subject is a human or other mammal, such as a primate, cat, dog, cow, horse, rodent, sheep, goat, or pig. In a particular example, the subject is a human patient.

[0077] Although methods and materials similar or equivalent to those described herein can be used in the practice or testing of the present disclosure, suitable methods and materials are described below. In case of conflict, the present specification, including terms, will control. In addition, the materials, methods, and examples are illustrative only and not intended to be limiting.

[0078] In view of the many possible embodiments to which the principles of the disclosed invention may be applied, it should be recognized that the illustrated embodiments are only examples of the invention and should not be taken as limiting the scope of the invention. Rather, the scope of the invention is defined by the following claims. We therefore claim as our invention all that comes within the scope and spirit of these claims.