Tissue Anchor with Tether Stop
20180353297 ยท 2018-12-13
Assignee
Inventors
Cpc classification
A61B2017/0414
HUMAN NECESSITIES
A61B2017/048
HUMAN NECESSITIES
A61F2/2442
HUMAN NECESSITIES
A61B17/0401
HUMAN NECESSITIES
International classification
A61F2/24
HUMAN NECESSITIES
A61B17/06
HUMAN NECESSITIES
Abstract
An expandable tissue anchor is provided that includes an elongate tissue-coupling portion configured to be delivered through a cardiac tissue wall, and a flexible elongate tension member, which is coupled to a portion of the tissue-coupling portion such that a tensile force can be applied to the tissue-coupling portion after it has been expanded. A portion of the tension member is slidably disposed through a passage defined by the anchor. A sleeve encloses a portion of the tension member between the tissue-coupling portion and a distal opening of the passage. The sleeve and the passage are sized and shaped such that the size and shape of the passage prevent proximal movement of the sleeve past the passage upon application of the tensile force to the tension member, thereby limiting compression and deformation of the expanded tissue-coupling portion by the tension member. Other embodiments are also described.
Claims
1. An expandable tissue anchor configured to be delivered to a cardiac chamber using a deployment tool, and to be anchored to a cardiac tissue wall at a target site such that a tensile force can be applied to the expandable tissue anchor and thus to the cardiac tissue wall, once the expandable tissue anchor is deployed, so as to move the cardiac tissue wall at the target site relative to adjacent cardiac tissue, the expandable tissue anchor comprising: an elongate tissue-coupling portion configured to be delivered in an unexpanded generally elongate configuration through the cardiac tissue wall from a first side of the cardiac tissue wall to a second side of the cardiac tissue wall, the tissue-coupling portion further configured to expand on the second side of the cardiac tissue wall; a flexible elongate tension member, which is coupled to a portion of the tissue-coupling portion of the expandable tissue anchor such that the tensile force can be applied to the tissue-coupling portion after it has been expanded, wherein a portion of the flexible elongate tension member is slidably disposed through a passage defined by the expandable tissue anchor; and a sleeve that encloses a portion of the flexible elongate tension member between (a) the tissue-coupling portion of the expandable tissue anchor and (b) a distal opening of the passage, wherein the sleeve and the passage are sized and shaped such that the size and shape of the passage prevent proximal movement of the sleeve past the passage upon application of the tensile force to the flexible elongate tension member, thereby limiting compression and deformation of the expanded tissue-coupling portion by the flexible elongate tension member.
2. The expandable tissue anchor according to claim 1, wherein the sleeve is axially slidable along the flexible elongate tension member.
3. The expandable tissue anchor according to claim 1, wherein the sleeve is configured such that the expanded tissue-coupling portion and the sleeve can be drawn tightly against the second side of the cardiac tissue wall at the target site when the tensile force is applied to the tissue-coupling portion.
4. The expandable tissue anchor according to claim 1, wherein the expandable tissue anchor is configured such that when the cardiac tissue wall is a myocardial tissue wall, the tissue-coupling portion of the expandable tissue anchor can be advanced into the pericardial cavity between visceral pericardium and parietal pericardium, generally alongside and against the parietal pericardium, without penetrating the parietal pericardium.
5. The expandable tissue anchor according to claim 1, further comprising an anchor head that supports the tissue-coupling portion at a proximal end of the tissue-coupling portion.
6. The expandable tissue anchor according to claim 5, wherein the anchor head is shaped so as to define the passage.
7. The expandable tissue anchor according to claim 6, wherein a lateral surface of the anchor head is shaped so as to define at least a portion of the distal opening of the passage.
8. The expandable tissue anchor according to claim 6, wherein the anchor head comprises a collar, which is shaped so as to define the distal opening of the passage.
9. The expandable tissue anchor according to claim 8, wherein a distal end of the collar is shaped so as to define the distal opening of the passage.
10. The expandable tissue anchor according to claim 8, wherein a lateral surface of the collar is shaped so as to define at least a portion of the distal opening of the passage.
11. The expandable tissue anchor according to claim 5, wherein the tissue-coupling portion of the expandable tissue anchor, once expanded on the second side of the cardiac tissue wall, assumes a shape generally orthogonal to the anchor head.
12. An anchor system comprising the expandable tissue anchor according to claim 1, wherein the anchor system further comprises a tether affixed to the flexible elongate tension member such that the tensile force can be applied to the expandable tissue anchor via the tether and the flexible elongate tension member.
13. A method for moving a cardiac tissue wall at a target site relative to adjacent cardiac tissue, the method comprising: delivering, to a cardiac chamber, an expandable tissue anchor in an unexpanded generally elongate configuration within a deployment tool, the expandable tissue anchor comprising (a) an elongate tissue-coupling portion, (b) a flexible elongate tension member coupled to a portion of the tissue-coupling portion, and (c) a sleeve that encloses a portion of the flexible elongate tension member between (i) the tissue-coupling portion of the expandable tissue anchor and (ii) a distal opening of a passage defined by the expandable tissue anchor, wherein a portion of the flexible elongate tension member is slidably disposed through the passage defined by the expandable tissue anchor; delivering the tissue-coupling portion in an unexpanded generally elongate configuration through the cardiac tissue wall from a first side of the wall to a second side of the wall, such that the tissue-coupling portion expands on the second side of the cardiac tissue wall, thereby anchoring the expandable tissue anchor to the cardiac tissue wall at the target site; partially compressing the expanded tissue-coupling portion by applying a tensile force to the flexible elongate tension member, until the passage prevents proximal movement of the sleeve past the passage, thereby limiting compression and deformation of the expanded tissue-coupling portion by the flexible elongate tension member; and after the passage prevents proximal movement of the sleeve past the passage, applying, to the flexible elongate tension member, additional tensile force that does not further compress or deform the expanded tissue-coupling portion, and thus is applied to the cardiac tissue wall, so as to move the cardiac tissue wall at the target site relative to the adjacent cardiac tissue.
14. The method according to claim 13, wherein the expandable tissue anchor further comprises an anchor head that supports the tissue-coupling portion at a proximal end of the tissue-coupling portion.
15. The method according to claim 13, wherein the anchor head is shaped so as to define the passage.
16. The method according to claim 15, wherein a lateral surface of the anchor head is shaped so as to define at least a portion of the distal opening of the passage.
17. The method according to claim 15, wherein the anchor head comprises a collar, which is shaped so as to define the distal opening of the passage.
18. The method according to claim 17, wherein a distal end of the collar is shaped so as to define the distal opening of the passage.
19. The method according to claim 17, wherein a lateral surface of the collar is shaped so as to define at least a portion of the distal opening of the passage.
20. The method according to claim 13, wherein the tissue-coupling portion and the expandable tissue anchor, once expanded on the second side of the cardiac tissue wall, comprises a configuration generally orthogonal to the anchor head.
21. The method according to claim 13, wherein the sleeve is axially slidable along the flexible elongate tension member.
22. The method according to claim 13, wherein applying the tensile force to the flexible elongate tension member comprises tightly drawing the expanded tissue-coupling portion and the sleeve against the second side of the cardiac tissue wall at the target site.
23. The method according to claim 13, wherein the cardiac tissue is a myocardial tissue wall, and wherein delivering the tissue-coupling portion in the unexpanded generally elongate configuration through the cardiac tissue wall comprises delivering the tissue-coupling portion through the cardiac tissue wall into the pericardial cavity between visceral pericardium and parietal pericardium, generally alongside and against the parietal pericardium, without penetrating the parietal pericardium.
24. The method according to claim 13, wherein applying the tensile force to the flexible elongate tension member comprises applying the tensile force to a tether affixed to the flexible elongate tension member.
Description
BRIEF DESCRIPTION OF THE DRAWINGS
[0039]
[0040]
[0041]
[0042]
DETAILED DESCRIPTION OF APPLICATIONS
[0043]
[0044] Expandable tissue anchor 120 further comprises a flexible elongate tension member 146 coupled to a portion of tissue-coupling portion 130 of expandable tissue anchor 120. Through flexible elongate tension member 146, or components equivalent thereto, the tensile force can be applied to tissue-coupling portion 130 after it has been expanded. When applied in vivo, the tensile force may have the benefit of bringing the anchor close to the tissue wall to which it is applied. For some applications, an anchor system 150 is provided that comprises expandable tissue anchor 120 and a tether 152 affixed to flexible elongate tension member 146 such that the tensile force can be applied to expandable tissue anchor 120 via tether 152 and flexible elongate tension member 146. Optionally, expandable tissue anchor 120 further comprises a tube 154 that surrounds a proximal portion of flexible elongate tension member 146. For some applications, anchor system 150 further comprises a second tissue anchor, separate and distinct from expandable tissue anchor 120, such as is shown in above-mentioned PCT Publication WO 2016/087934. For some applications, the second tissue anchor, and additional anchors if so desired, is couplable or coupled to expandable tissue anchor 120 by one or more tethers that include tether 152.
[0045] Expandable tissue anchor 120 further comprises a sleeve 190 that encloses a portion of flexible elongate tension member 146 between (a) tissue-coupling portion 130 of expandable tissue anchor 120 and (b) a distal opening 194 of a passage 191 through expandable tissue anchor 120, such that expanded tissue-coupling portion 130 (and, optionally, sleeve 190) can be drawn tightly against the second side of the cardiac tissue wall at the target site when the tensile force is applied to tissue-coupling portion 130.
[0046] Distal opening 194 of passage 191 is typically located near (e.g., at) a distal end 192 of anchor head 196. A portion of flexible elongate tension member 146 is slidably disposed through passage 191. For some applications, passage 191 is defined by anchor head 196 (as shown). For example, distal opening 194 may be defined by a tubular anchor shaft 132 that anchor head 196 comprises; anchor head 196 may optionally implement techniques described in above-mentioned PCT Publication WO 2016/087934. For some applications, in addition to or instead of tubular anchor shaft 132, anchor head 196 comprises one or more collars 197, such as distal and proximal collars 197A and 197B, as shown, or exactly one collar 197 (configuration not shown). For some of these applications, distal opening 194 is defined by a distal end of distal collar 197A (as shown in
[0047] Sleeve 190 and passage 191 are sized and shaped such that the size and shape of passage 191 prevent proximal movement of sleeve 190 past passage 191 (e.g., prevent proximal movement of sleeve 190 into distal opening 194). Sleeve 190 and passage 191 thus limit movement of tissue-coupling portion 130 toward distal end 192 of anchor head 196 upon application of the tensile force to flexible elongate tension member 146. This is the case because sleeve 190 has sufficient axial stiffness and too large an outer diameter to pass through passage 191 (e.g., including distal opening 194), and a distal (far) end 193 of sleeve 190 contacts tissue-coupling portion 130 near a junction 195 between flexible elongate tension member 146 and tissue-coupling portion 130, such as shown in
[0048] Attachment of sleeve 190 to flexible elongate tension member 146 is relatively simple during manufacture of expandable tissue anchor 120, as sleeve 190 need not be, and indeed typically is not, axially fixed to flexible elongate tension member 146. Even though sleeve 190 is typically axially slidable along flexible elongate tension member 146, the sleeve nevertheless serves its compression-limiting function, as described hereinabove.
[0049] In addition, sleeve 190 may generally increase the contact area between flexible elongate tension member 146 and the second site of the cardiac tissue wall. As a result, sleeve 190 may generally reduce the likelihood of flexible elongate tension member 146 cutting the cardiac tissue wall, particularly if the tissue is diseased.
[0050] For some applications, sleeve 190 has an outer diameter of at least 0.5 mm, no more than 1 mm, and/or between 0.5 and 1 mm, such as 0.75 mm. For some applications, sleeve 190 has a length of at least 2 mm, no more than 6 mm, and/or between 2 and 6 mm, such as between 3 and 5 mm, e.g., 4 mm. For some applications, sleeve 190 comprises PET, PEEK, a closely wound metal coil spring, porous ePTFE, or woven PET fiber.
[0051] For some applications, tissue-coupling portion 130, once expanded on the second side of the cardiac tissue wall, such as described hereinbelow with reference to
[0052] For some applications, as shown in
[0053] Reference is now made to
[0054] As shown in
[0055] (RCA) 178. For some applications, deployment tool 170 is then further directed into the pericardial cavity 180 between visceral pericardium 182 and parietal pericardium 184, carefully avoiding puncturing parietal pericardium 184 and fibrous pericardium 186.
[0056] As shown in
[0057] As shown in
[0058] For some applications, after application of the tensile force, all or a portion of sleeve 190 rests against the second side of myocardial tissue wall 160, generally helping prevent possible inadvertent cutting of myocardial tissue wall 160 by flexible elongate tension member 146. For some applications, such as shown in
[0059] Reference is made to
[0060] For some applications, wire 189 comprises a shape-memory alloy, which is configured to automatically transition to a predetermined shape upon deployment of tissue-coupling portion 130 on the second side of the cardiac tissue wall. For some of these applications, tissue-coupling portion 130 comprises tip 188, while for others of these applications, tissue-coupling portion 130 does not comprise tip 188.
[0061] Reference is still made to
[0062] Reference is now made to
[0063] An anchor head 296 of expandable tissue anchor 220 supports elongate tissue-coupling portion 130 at a proximal end of the tissue-coupling portion. A lateral surface 299 of anchor head 296, typically near a distal end 292 of anchor head 296, is shaped so as to define at least a portion of a distal opening 294 of a passage 291 through expandable tissue anchor 220. For some applications, anchor head 296 comprises one or more collars 297, such as distal and proximal collars 297A and 297B, as shown. Lateral surface 299 may be defined by distal collar 297A, typically near distal end 292 of anchor head 296. Alternatively, anchor head 296 comprises exactly one collar 297, and distal opening 294 is defined by a lateral surface of the exactly one collar (configuration not shown). Further alternatively, anchor head 296 does not comprise any collars 297, and distal opening 294 of passage 291 is defined by a lateral wall of another portion of anchor head 296, such as of a tubular anchor shaft 232 that anchor head 296 comprises (configuration not shown). For some applications, passage 291 includes more than one passage 291, as shown. Passage 291 is typically a channel, but may also be a groove (e.g., a U-shaped groove).
[0064] A portion of flexible elongate tension member 146 is slidably disposed through passage 291. Sleeve 190 and passage 291 are sized and shaped such that the size and shape of passage 291 prevent proximal movement of sleeve 190 past passage 291 (e.g., prevent proximal movement of sleeve 190 into distal opening 294). Sleeve 190 and passage 291 thus limit movement of tissue-coupling portion 130 toward distal end 192 of anchor head 196 upon application of the tensile force to flexible elongate tension member 146. This is the case because sleeve 190 has sufficient axial stiffness and too large an outer diameter to pass through passage 291 (e.g., including distal opening 294), and a distal (far) end of sleeve 190 contacts tissue-coupling portion 130 near a junction between flexible elongate tension member 146 and tissue-coupling portion 130, such as shown in
[0065] Locating distal opening 294 of passage 291 at least partially through lateral surface 299 of distal collar 297A may reduce the load on the curved portion of flexible elongate tension member 146 in the vicinity of distal opening 294. In addition, any damage to the proximal end of sleeve 190 is reduced or avoided because the proximal end of sleeve 190 is oriented perpendicularly with distal opening 294 at the point of contact with the distal opening. Further, in this arrangement, flexible elongate tension member 146 is not subject to shear between sleeve 190 and the edge of distal opening 294.
[0066] Reference is now made to
[0067] In this configuration, a passage 391 through expandable tissue anchor 320 is defined at least in part by tissue-coupling portion 130 of expandable tissue anchor 320. A distal opening 394 of passage 391 may be defined by wire 189 of tissue-coupling portion 130, which, in this configuration, includes at least a portion that is hollow (i.e., tubular), through which a portion of flexible elongate tension member 146 passes. Optionally, passage 391 is also defined by (a) an anchor head 396 of expandable tissue anchor 120 that supports elongate tissue-coupling portion 130 at a proximal end of the tissue-coupling portion. For some applications, anchor head 396 comprises one or more collars 397, such as distal and proximal collars 397A and 397B, as shown, or exactly one collar 397, and passage 391 passes through the one or more collars 397. For some applications, passage 391 includes more than one passage 391, as shown. Passage 391 is typically a channel, but may also be a groove (e.g., a U-shaped groove).
[0068] 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. For some applications, techniques and apparatus described in one or more of the following applications are combined with techniques and apparatus described herein: [0069] U.S. Pat. No. 8,475,525 to Maisano et al.; [0070] U.S. Pat. No. 8,961,596 to Maisano et al.; [0071] U.S. Pat. No. 8,961,594 to Maisano et al.; [0072] PCT Publication WO 2011/089601; [0073] U.S. Pat. No. 9,241,702 to Maisano et al.; [0074] U.S. Provisional Application 61/750,427, filed Jan. 9, 2013; [0075] U.S. Provisional Application 61/783,224, filed Mar. 14, 2013; [0076] U.S. Provisional Application 61/897,491, filed Oct. 30, 2013; [0077] U.S. Provisional Application 61/897,509, filed Oct. 30, 2013; [0078] U.S. Pat. No. 9,307,980 to Gilmore et al.; [0079] PCT Publication WO 2014/108903; [0080] PCT Publication WO 2014/141239; [0081] U.S. Provisional Application 62/014,397, filed Jun. 19, 2014; [0082] PCT Publication WO 2015/063580; [0083] US Patent Application Publication 2015/0119936; [0084] U.S. Provisional Application 62/086,269, filed Dec. 2, 2014; [0085] U.S. Provisional Application 62/131,636, filed Mar. 11, 2015; [0086] U.S. Provisional Application 62/167,660, filed May 28, 2015; [0087] PCT Publication WO 2015/193728; [0088] PCT Publication WO 2016/087934; [0089] US Patent Application Publication 2016/0235533; [0090] US Patent Application Publication 2016/0242762; [0091] PCT Publication WO 2016/189391; [0092] US Patent Application Publication 2016/0262741; [0093] U.S. Provisional Application 62/376,685, filed Aug. 18, 2016; [0094] U.S. Provisional Application 62/456,206, filed Feb. 8, 2017; [0095] U.S. Provisional Application 62/456,202, filed Feb. 8, 2017; [0096] U.S. Provisional Application 62/465,410, filed Mar. 1, 2017; and [0097] U.S. Provisional Application 62/465,400, filed Mar. 1, 2017.
[0098] Patents and patent application publications incorporated by reference in the present patent application are to be considered an integral part of the application except that to the extent any terms are defined in these incorporated patents and patent application publications in a manner that conflicts with the definitions made explicitly or implicitly in the present specification, only the definitions in the present specification should be considered.
[0099] 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.