Post-Implantation Tensioning in Cardiac Implants
20200261228 ยท 2020-08-20
Assignee
Inventors
- Andrea Guidotti (Zurich, CH)
- Idan Tobis (Beth Hashmonai, IL)
- Kevin Lynn (Athenry, IE)
- Chris Moran (Claremorris, IE)
- Michael Gilmore (Ardrahan, IE)
Cpc classification
A61F2/915
HUMAN NECESSITIES
A61F2/2451
HUMAN NECESSITIES
A61B2017/0488
HUMAN NECESSITIES
A61F2/2442
HUMAN NECESSITIES
A61F2/2427
HUMAN NECESSITIES
A61B17/0401
HUMAN NECESSITIES
A61F2002/30477
HUMAN NECESSITIES
International classification
A61F2/24
HUMAN NECESSITIES
Abstract
A method of treating a heart of a patient is provided. The method includes implanting a first tissue anchor in cardiac tissue of the patient and a second tissue anchor in the patient, such that the first and the second tissue anchors are coupled together by one or more tethers. Thereafter, after allowing at least 24 hours for tissue growth on the first tissue anchor to strengthen anchoring of the first tissue anchor in the cardiac tissue, tension is applied between the first and the second tissue anchors using at least a longitudinal portion of the one or more tethers. Other embodiments are also described.
Claims
1. A method of treating a heart of a patient, comprising: implanting a first tissue anchor in cardiac tissue of the patient and a second tissue anchor in the patient, such that the first and the second tissue anchors are coupled together by one or more tethers; thereafter, after allowing at least 24 hours for tissue growth on the first tissue anchor to strengthen anchoring of the first tissue anchor in the cardiac tissue, applying tension between the first and the second tissue anchors using at least a longitudinal portion of the one or more tethers.
2. The method according to claim 1, wherein the one or more tethers are slack before applying the tension.
3. The method according to claim 1, wherein the one or more tethers are one or more first tethers, and wherein applying the tension comprises: coupling a second tether to a coupling site along the one or more first tethers; and applying the tension between the first and the second tissue anchors using the at least a longitudinal portion of the one or more first tethers and the second tether.
4. The method according to claim 3, wherein coupling the second tether to the coupling site comprises coupling, to the coupling site, a coupling element that is attached to the second tether.
5. The method according to claim 4, wherein the coupling element comprises a hook.
6. The method according to claim 3, wherein applying the tension comprises coupling the second tether to the second tissue anchor.
7. The method according to claim 6, wherein the second tissue anchor comprises a stent that comprises a plurality of struts, and wherein coupling the second tether to the second tissue anchor comprises coupling, to one or more of the struts, a coupling element that is attached to the second tether.
8. The method according to claim 7, wherein the coupling element comprises a hook.
9. The method according to claim 7, wherein the coupling element is shaped so as to define an opening.
10. The method according to claim 7, wherein at least one of the struts is oriented axially as a backbone, and wherein coupling the coupling element to the one or more of the struts comprises coupling the coupling element to the backbone.
11. The method according to claim 10, wherein the backbone is shaped so as to define one or more hooks, and wherein coupling the coupling element to the backbone comprises coupling the coupling element to one or more of the hooks.
12. The method according to claim 1, wherein a longitudinal portion of the one or more tethers passes through one or more openings of a locking frame so as to form a tether loop, and wherein applying the tension comprises enlarging the tether loop by pulling on the tether loop.
13. The method according to claim 12, wherein the one or more openings are two openings, and wherein the longitudinal portion of the one or more tethers passes through the two openings.
14. The method according to claim 1, wherein applying the tension comprises applying the tension after allowing at least one week for tissue growth on the first tissue anchor.
15. The method according to claim 1, wherein applying the tension comprises applying the tension within two months after implanting the first tissue anchor.
16. The method according to claim 1, wherein implanting the first tissue anchor comprises implanting the first tissue anchor in the vicinity of the tricuspid valve of the patient.
17. The method according to claim 1, wherein implanting the second tissue anchor comprises implanting the second tissue anchor in a blood vessel selected from the group consisting of: a superior vena cava (SVC), an inferior vena cava (IVC), and a coronary sinus.
18. A method of treating a heart of a patient, comprising: implanting a first tissue anchor in cardiac tissue of the patient; thereafter, after allowing at least 24 hours for tissue growth on the first tissue anchor to strengthen anchoring of the first tissue anchor in the cardiac tissue: implanting a second tissue anchor in the patient; coupling the first and the second tissue anchors together using one or more tethers; and applying tension between the first and the second tissue anchors using the one or more tethers.
19. The method according to claim 18, wherein coupling the first and the second tissue anchors together comprises coupling the first and the second tissue anchors together after implanting the second tissue anchor.
20. The method according to claim 18, wherein coupling the first and the second tissue anchors together comprises coupling the first and the second tissue anchors together before implanting the second tissue anchor.
21. The method according to claim 18, wherein the one or more tethers are one or more first tethers, wherein the method further comprises implanting a third tissue anchor in cardiac tissue of the patient, such that the first and the third tissue anchors are coupled together by one or more second tethers, wherein coupling the first and the second tissue anchors together comprises coupling the first, the second, and the third tissue anchors together using the one or more first tethers and the one or more second tethers, and wherein applying the tension between the first and the second tissue anchors comprises applying the tension between the first, the second, and the third tissue anchors using the one or more first tethers and the one or more second tethers.
22. The method according to claim 21, wherein implanting the third tissue anchor comprises implanting the third tissue anchor within three hours of implanting the first tissue anchor.
23. The method according to claim 21, wherein the one or more first tethers are attached to the second tissue anchor and comprise a coupling element, and wherein coupling the first, the second, and the third tissue anchors together using the one or more first tethers and the one or more second tethers comprises coupling the coupling element to the one or more second tethers.
24. The method according to claim 23, wherein the coupling element comprises a hook, and wherein coupling the coupling element to the one or more second tethers comprises hooking the hook onto the one or more second tethers.
25. The method according to claim 18, wherein the first tissue anchor comprises a tissue-anchoring element and a first coupling element, wherein the one or more tethers are attached to the second tissue anchor and comprise a second coupling element, and wherein coupling the first and the second tissue anchors together using the one or more tethers comprises coupling the second coupling element to the first coupling element.
26. The method according to claim 25, wherein the first coupling element comprises a ball, wherein the second coupling element comprises a socket, and wherein coupling the first and the second tissue anchors together comprises coupling the socket to the ball.
27. The method according to claim 26, wherein the ball is connected to a head of the first tissue anchor by a rod.
28. The method according to claim 26, wherein coupling the socket to the ball comprises transitioning the socket from an open, unlocked state to a closed, locked state around the ball.
29. The method according to claim 25, wherein the first coupling element comprises a socket, wherein the second coupling element comprises a ball, and wherein coupling the first and the second tissue anchors together comprises coupling the ball to the socket.
30. The method according to claim 25, wherein the first coupling element comprises a loop, wherein the second coupling element comprises a hook, and wherein coupling the first and the second tissue anchors together comprises hooking the hook onto the loop.
31. The method according to claim 25, wherein the second coupling element comprises a loop, and wherein coupling the first and the second tissue anchors together comprises coupling the loop to the first coupling element.
32. The method according to claim 31, wherein the first coupling element comprises a hook, and wherein coupling the loop to the first coupling element comprises coupling the loop to the hook.
33. The method according to claim 25, wherein the first coupling element is coated with a tissue-growth-inhibiting coating.
34. The method according to claim 25, wherein the tissue-anchoring element is coated with a tissue-growth-enhancing coating.
35. The method according to claim 18, wherein implanting the second tissue anchor comprises implanting the second tissue anchor after allowing at least one week for tissue growth on the first anchor.
36. The method according to claim 18, wherein implanting the second tissue anchor comprises implanting the second tissue anchor within two months after implanting the first tissue anchor.
37. The method according to claim 18, wherein the first tissue anchor comprises a helical tissue-anchoring element.
38. The method according to claim 18, wherein the second tissue anchor comprises a stent.
39. The method according to claim 18, wherein implanting the second tissue anchor comprises implanting the second tissue anchor in a blood vessel selected from the group consisting of: a superior vena cava (SVC), an inferior vena cava (IVC), and a coronary sinus.
40. The method according to claim 18, wherein implanting the first tissue anchor comprises implanting the first tissue anchor in the vicinity of the tricuspid valve.
41. The method according to claim 40, wherein applying the tension between the first and the second tissue anchors using the one or more tethers reduces tricuspid valve regurgitation.
Description
BRIEF DESCRIPTION OF THE DRAWINGS
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DETAILED DESCRIPTION OF APPLICATIONS
[0126]
[0127] As shown in
[0128] For some applications, at this first stage of the implantation procedure, the one or more tethers 32 are slack, i.e., do not apply tension between first and second tissue anchors 30 and 40.
[0129] As shown in
[0130] For some applications, such as shown in
[0131] For some applications, coupling second tether 50 to coupling site 52 comprises coupling, to coupling site 52, a coupling element 56 that is attached to second tether 50. For example, coupling element 56 may comprise a hook, as shown in
[0132] Typically, applying the tension comprises coupling second tether 50 to second tissue anchor 40. For some applications, as shown, second tissue anchor 40 comprises a stent 58 that comprises a plurality of struts 60, and coupling second tether 50 to second tissue anchor 40 comprises coupling, to one or more of struts 60, a coupling element 62 that is attached to second tether 50. For some applications, coupling element 62 is shaped so as to define an opening 64, e.g., exactly one opening 64 or a plurality of openings 64, arranged, for example, axially along coupling element 62. Optionally, opening 64 is defined by a loop of coupling element 62. Providing a plurality of openings 64 provides redundancy; in case one of the openings does not catch on stent 58, another of the openings may catch (or both may catch, as shown in the figures). Optionally, coupling element 62 comprises one or more loops that are shaped so as to define the one or more openings 64, respectively.
[0133] For some applications, at least one of struts 60 is oriented axially (i.e., along the axis of the stent) as a backbone 70 (which may be thicker, wider, and/or stronger than other struts 60 and/or other axially-oriented struts 60). Coupling element 62 is coupled to backbone 70. In one configuration, backbone 70 is shaped so as to define one or more hooks 72 (e.g., exactly one hook 72, or two or more hooks 72), and coupling element 62 is coupled to one or more of hooks 72. For example, coupling element 62 may be shaped so as to define one or more openings 64, as described above. Providing a plurality of hooks 72 provides redundancy, as discussed above regarding openings 64.
[0134] Alternatively, for some applications, coupling element 62 comprises one or more hooks, which are hooked onto one or more of struts 60, such as backbone 70. For example, coupling element 62 may comprise one of coupling elements 96A, 96B, 96C, and 96D, described hereinbelow with reference to
[0135] Reference is made to
[0136] For some applications, such as shown in
[0137] Reference is made to
[0138] Reference is again made to
[0139] Reference is now made to
[0140] As shown in
[0141] Upon completion of the first stage of the implantation procedure, first tissue anchor 130 has no beneficial effect by itself on the heart. For example, first tissue anchor 130 does not reshape the heart valve or reduce valve regurgitation by itself.
[0142] As shown in
[0146] First and second tissue anchors 130 and 140 may be coupled together either after or before implanting second tissue anchor 140. For some applications, second tissue anchor 140 is implanted in superior vena cava (SVC) 42, inferior vena cava (IVC) 44 (as shown), or coronary sinus 46. Typically, second tissue anchor 140 is implanted in a transcatheter procedure (typically endovascularly, such as percutaneously), via one or more catheters 48, such as described in the applications incorporated hereinbelow by reference. For some applications, second tissue anchor 140 is implanted within two months after implanting first tissue anchor 130. (The catheter used during the second stage of the implantation procedure may be introduced through the same vena cava as during the first stage of the implantation procedure, or through the other vena cava.)
[0147] For some applications, the one or more tethers 132 are fixed to second tissue anchor 140 before second tissue anchor 140 is introduced into the patient's body, while for other applications, the one or more tethers 132 are coupled to second tissue anchor 140 during the second stage of the implantation procedure, such as using techniques described hereinabove with reference to
[0148] Optionally, the one or more tethers 32 comprise two tethers 32 that are coupled together in situ during the second stage of the implantation procedure, such as using techniques described in one or more of the applications incorporated by reference hereinbelow.
[0149] For some applications, as shown in
[0150] Reference is made to
[0151] Reference is made to
System 168 may alternatively or additionally comprise any of the other elements and/or features described hereinabove with reference to
[0155] Reference is now made to
[0156] Reference is made to
[0160] System 169 may alternatively or additionally comprise any of the other elements and/or features described hereinabove with reference to
[0161] Reference is now made to
[0162] For some applications, such as shown in
[0163] Reference is made to
System 180 may alternatively or additionally comprise any of the other elements and/or features described hereinabove with reference to
[0167] Reference is made to
[0168] Reference is still made to
System 190 may alternatively or additionally comprise any of the other elements and/or features described hereinabove with reference to
[0172] Reference is now made to
[0173] In addition to implanting first tissue anchor 130, such as described hereinabove with reference to
[0174] First and second tissue anchors 130 and 140 are coupled together by coupling first, second, and third tissue anchors 130, 140, and 210 together using the one or more first tethers 132 and the one or more second tethers 212. The tension is applied between first and second tissue anchors 130 and 140 by applying the tension between first, second, and third tissue anchors 130, 140, and 210 using the one or more first tethers 132 and the one or more second tethers 212.
[0175] For some applications, the one or more first tethers 132 are attached to second tissue anchor 140 (typically before introducing second tissue anchor 140 into the patient's body) and comprise a coupling element 146. First, second, and third tissue anchors 130, 140, and 210 are coupled together by coupling coupling element 146 to the one or more second tethers 212. For some applications, coupling element 146 comprises a hook 214, and coupling element 146 is coupled to the one or more second tethers 212 by hooking hook 214 onto the one or more second tethers 212. Optionally, coupling element 146 may comprise one of coupling elements 96A, 96B, 96C, and 96D, described hereinabove with reference to
[0176] Reference is made to
Coupling element 146 is configured to be coupled to the one or more second tethers 212, to facilitate applying tension between first, second, and third tissue anchors 130, 140, and 210 using the one or more first tethers 132 and the one or more second tethers 212. System 220 may alternatively or additionally comprise any of the other elements and/or features described hereinabove with reference to
[0181] For some applications, fibrous glue is applied to the tissue-coupling elements of the tissue anchors described herein to help secure the anchors in place and minimize detachment. Optionally, tissue-growth-enhancing coating is also applied to the tissue-coupling elements, as described hereinabove.
[0182] The scope of the present invention includes embodiments described in the following applications, which are assigned to the assignee of the present application and are incorporated herein by reference. In an embodiment, techniques and apparatus described in one or more of the following applications are combined with techniques and apparatus described herein: [0183] U.S. Pat. No. 8,475,525 to Maisano et al.; [0184] U.S. Pat. No. 8,961,596 to Maisano et al.; [0185] U.S. Pat. No. 8,961,594 to Maisano et al.; [0186] PCT Publication WO 2011/089601; [0187] U.S. Pat. No. 9,241,702 to Maisano et al.; [0188] PCT Publication WO 2013/011502; [0189] U.S. Provisional Application 61/750,427, filed Jan. 9, 2013; [0190] U.S. Provisional Application 61/783,224, filed Mar. 14, 2013; [0191] PCT Publication WO 2013/179295; [0192] U.S. Provisional Application 61/897,491, filed Oct. 30, 2013; [0193] U.S. Provisional Application 61/897,509, filed Oct. 30, 2013; [0194] U.S. Pat. No. 9,307,980 to Gilmore et al.; [0195] PCT Publication WO 2014/108903; [0196] PCT Publication WO 2014/141239; [0197] U.S. Provisional Application 62/014,397, filed Jun. 19, 2014; [0198] PCT Publication WO 2015/063580; [0199] US Patent Application Publication 2015/0119936; [0200] U.S. Provisional Application 62/086,269, filed Dec. 2, 2014; [0201] U.S. Provisional Application 62/131,636, filed Mar. 11, 2015; [0202] U.S. Provisional Application 62/167,660, filed May 28, 2015; [0203] PCT Publication WO 2015/193728; [0204] PCT Publication WO 2016/087934; [0205] US Patent Application Publication 2016/0242762; [0206] PCT Publication WO 2016/189391; [0207] US Patent Application Publication 2016/0262741; and [0208] U.S. Provisional Application 62/376,685, filed Aug. 18, 2016.
[0209] It will be appreciated by persons skilled in the art that the present invention is not limited to what has been particularly shown and described hereinabove. Rather, the scope of the present invention includes both combinations and subcombinations of the various features described hereinabove, as well as variations and modifications thereof that are not in the prior art, which would occur to persons skilled in the art upon reading the foregoing description.