FABRIC FIBER ARRANGEMENTS FOR CARDIAC IMPLANTS
20210093453 · 2021-04-01
Inventors
- Carmel Peleg (Neve Monoson, IL)
- Amit Peer (Rehovot, IL)
- Meir KUTZIK (Holon, IL)
- Alon Fogel (Tel Aviv-Yafo, IL)
- Ben Azouri (Tel Aviv, IL)
- Haim Brauon (Beit Dagan, IL)
- Shlomit Chappel-Ram (Ramat HaSharon, IL)
- Tal Reich (Moledet, IL)
Cpc classification
A61F2220/0075
HUMAN NECESSITIES
A61F2220/0016
HUMAN NECESSITIES
A61F2250/0018
HUMAN NECESSITIES
A61F2/2445
HUMAN NECESSITIES
A61F2230/0091
HUMAN NECESSITIES
International classification
Abstract
An implant comprises a first fabric and a second fabric. The first fabric comprises first fibers, disposed in a first orientation, and second fibers interwoven with the first fibers and disposed in a second orientation that is different to the first orientation. The second fabric comprises third fibers, and fourth fibers interwoven with the third fibers. The second fabric is attached to the first fabric in a manner in which: the first and second fabrics collectively form a body portion of the implant, the third fibers are disposed in a third orientation that is different to the first and second orientations, and the fourth fibers are disposed in a fourth orientation that is different to the first, second, and third orientations. The body portion is configured to be secured to an upstream surface of a native valve of a heart of a subject. Other embodiments are also described.
Claims
1-82. (canceled)
83. Apparatus for treating a native valve of a heart of a subject, the apparatus comprising an implant, the implant comprising: a first fabric, comprising: first fibers, disposed in a first orientation, and second fibers, interwoven with the first fibers, and disposed in a second orientation that is different to the first orientation; and a second fabric: comprising third fibers, and fourth fibers interwoven with the third fibers, and attached to, and aligned with, the first fabric in a manner in which: the first and second fabrics collectively form a body portion of the implant, the body portion configured to be secured to the native valve, the third fibers are disposed in a third orientation that is different to the first and second orientations, and the fourth fibers are disposed in a fourth orientation that is different to the first, second, and third orientations.
84. The apparatus according to claim 83, wherein the second fabric is configured to be attached to tissue of the valve.
85. The apparatus according to claim 83, further comprising an attachment means, configured to attach the implant to tissue of the valve.
86. The apparatus according to claim 85, wherein the attachment means comprises a tissue anchor.
87. The apparatus according to claim 86, wherein the tissue anchor is configured to anchor the implant to the tissue by being driven through the second fabric and into the tissue.
88. The apparatus according to claim 86, wherein the tissue anchor is a helical tissue anchor.
89. The apparatus according to claim 83, wherein the body portion has a length and a width, the length being greater than the width and defining a longitudinal axis of the implant; and the first orientation is offset with respect to the longitudinal axis.
90. The apparatus according to claim 89, wherein the first fibers are disposed at 0-70 degrees with respect to the longitudinal axis.
91. The apparatus according to claim 90, wherein the first fibers are disposed at 45 degrees with respect to the longitudinal axis.
92. The apparatus according to claim 90, wherein the second fibers are disposed at 110-160 degrees with respect to the longitudinal axis.
93. The apparatus according to claim 92, wherein the second fibers are disposed at 135 degrees with respect to the longitudinal axis.
94. The apparatus according to claim 90, wherein the third fibers are disposed at 0-15 degrees with respect to the longitudinal axis.
95. The apparatus according to claim 94, wherein the third fibers are disposed at 0 degrees with respect to the longitudinal axis.
96. The apparatus according to claim 94, wherein the fourth fibers are disposed at 75-90 degrees with respect to the longitudinal axis.
97. The apparatus according to claim 96, wherein the fourth fibers are disposed at 90 degrees with respect to the longitudinal axis.
98. The apparatus according to claim 83, wherein the implant further comprises a flexible elongate member, coupled to the body portion such that, while the body portion is secured to the upstream surface, tensioning of the flexible elongate member adjusts the implant.
99. The apparatus according to claim 98, wherein the flexible elongate member comprises a wire.
100. The apparatus according to claim 98, wherein the flexible elongate member comprises a suture.
101. The apparatus according to claim 83, wherein the first fabric comprises polyethylene terephthalate.
102. The apparatus according to claim 101, wherein the first fibers comprise polyethylene terephthalate.
103. The apparatus according to claim 102, wherein the second fabric comprises polyethylene terephthalate.
104. The apparatus according to claim 103, wherein the third fibers comprise polyethylene terephthalate.
105. The apparatus according to claim 104, wherein the second fibers comprise polyethylene terephthalate.
106. The apparatus according to claim 105, wherein the fourth fibers comprise polyethylene terephthalate.
Description
BRIEF DESCRIPTION OF THE DRAWINGS
[0162]
[0163]
[0164]
[0165]
[0166]
[0167]
[0168]
[0169]
[0170]
[0171]
[0172]
DETAILED DESCRIPTION OF EMBODIMENTS
[0173] The following description and accompanying figures, which describe and show certain embodiments, are made to demonstrate, in a non-limiting manner, several possible configurations of systems, apparatuses, devices, methods, etc. that may be used for various aspects and features of the present disclosure. As one example, various systems, devices/apparatuses, and methods are described herein, including systems, platforms, devices, methods, etc. that relate to adjustable annuloplasty devices.
[0174]
[0175] Each controllably-expandable section 40 can comprise a respective part of the flexible material of sleeve 26. During manufacture of sleeve 26, each section 40, which defines the part of sleeve 26 can be folded, or invaginated. Each of these parts can be folded telescopically in a direction A away from a longitudinal axis 21 of annuloplasty structure 22. This direction can be perpendicular to axis 21. Such telescopic folding enables compression of parts of sleeve 26 without affecting an overall inner diameter of sleeve 26, as shown in
[0176] Each of controllably-expandable sections 40, when in a compressed state, can define a longitudinal length L1 of 6-10 mm, e.g., 8 mm, measured longitudinal axis 21 of structure 22. When in an expanded state, each of controllably-expandable sections 40 can define a longitudinal length L2 of 12-18 mm, e.g., 16 mm, measured longitudinal axis 21 of structure 22. Longitudinal length L2 is greater than longitudinal length L1.
[0177] Each section 40 can be folded so as to form a pouch 43 between layers of folds of section 40. Pouch 43 can have a longitudinal length L13 of 6.5-9.5 mm, e.g., 7.5 mm, that is measured along a pouch axis that is generally parallel with a longitudinal axis of the annuloplasty ring body portion at the part of the annuloplasty ring body portion that comprises section 40.
[0178] Each fold of section 40 can optionally be held together by a knot 44, e.g., a slip knot or any other tie which can come apart easily. For some applications, sleeve 26 is manufactured such that sections 40 are biased such that each section 40 expands passively upon removal of knot 44. For some applications, as shown hereinbelow, each section 40 can be pulled open by a respective control wire.
[0179] For some applications, sleeve 26 is expanded once structure 22 is positioned against cardiac tissue.
[0180] As illustrated in the bottom figure in
[0181] For some applications, each section 42 is labeled with a radiopaque marker. For some applications, each section 42 is designated as an anchor-designated section. In the illustrated application, structure 22 comprises a plurality of controllably-expandable sections 40 that are alternately disposed with a plurality of anchor-designated sections 42.
[0182] Sleeve 26 can comprise a braided fabric mesh, e.g., comprising polyethylene terephthalate, Dacron™, other materials, etc. Body portion 23 (e.g., sleeve 26) can be configured to be placed only partially around a cardiac valve annulus (i.e., to assume a C-shape), and, once anchored in place, to be contracted so as to circumferentially tighten the valve annulus. Optionally, the body portion can be configured to be placed entirely around the valve annulus. In order to tighten the annulus, the system 20 can comprise an actuatable adjustment mechanism or contracting mechanism. The adjustment mechanism or contracting mechanism can be part of and/or coupled to one or more of the annuloplasty structure 22, a flexible elongate contracting member 30 that extends along sleeve 26, and/or another component of the system (e.g., a catheter, etc.). Elongate contracting member 30 can comprise a wire, a ribbon, a rope, or a band, which can comprise a flexible and/or superelastic material, e.g., nitinol, polyester, stainless steel, or cobalt chrome. For some applications, the contracting member 30 comprises a radiopaque material. For some applications, contracting member 30 comprises a braided polyester suture (e.g., Ticron). For some applications, contracting member 30 is coated, such as with polytetrafluoroethylene (PTFE) or another polymer. For some applications, contracting member 30 comprises a plurality of wires that are intertwined to form a rope structure.
[0183] The actuatable adjustment mechanism or contraction mechanism can be configured in a variety of ways. For some applications, for example, the actuatable adjustment mechanism comprises a spool or rotating member around which the contracting member can collect. For some applications, the actuatable adjustment mechanism comprises a tensioner that causes a tension force to be applied to the contraction member. For some applications, the actuatable adjustment mechanism comprises a gripper that grips the contraction member in a way that allows a user to apply a tension force to the contraction member. For some applications, the actuatable adjustment mechanism comprises a catheter or multiple catheters configured to interact to draw the contracting member proximally and/or tension it to cause contraction of the annuloplasty structure (e.g., one catheter gripping and allowing pulling of the contraction member, while another catheter provides a resisting force to the annuloplasty structure, etc.). Other applications are also possible.
[0184] Once the physician has positioned structure 22 along the annulus and has expanded any number of controllably-expandable sections 40, contracting member 30 is used to contract annuloplasty structure 22. For some applications, contracting member 30 is coupled to an actuatable contracting mechanism as described in US Patent Application Publication 2014/0309661 to Sheps et al., and/or in US Patent Application Publication 2015/0272734 to Sheps et al., which are incorporated herein by reference. Additionally, implantation of structure 22 can be done using any methods described in the '661 and/or '734 applications.
[0185]
[0186] Structure 122 can comprise a single control wire 50 which is connected to all knots 44 and thereby to all controllably-expandable sections 40 (though multiple control wires can be used in some embodiments). In the illustrated embodiment, once control wire 50 is pulled, as shown, wire 50 releases all of knots 44. Once all of knots 44 are released, sleeve 26 can expand fully and be anchored to tissue. As shown in
[0187] As shown in
[0188] Once the physician has positioned structure 122 along the annulus and has expanded any number of controllably-expandable sections 40, contracting member 30 is used to contract structure 122. For some applications, contracting member 30 is coupled to and/or is part of an actuatable contracting mechanism or adjustment mechanism, for example, as described elsewhere herein and/or as described in US Patent Application Publication 2014/0309661 to Sheps et al., and/or in US Patent Application Publication 2015/0272734 to Sheps et al., which are incorporated herein by reference. Additionally, implantation of structure 122 can be done using any methods described in the '661 and/or '734 applications.
[0189]
[0190] Structure 222 can comprise a plurality of control wires, for example wires 50a, 50b, and 50c. That is, structure 222 can comprise a respective control wire 50 for each controllably-expandable section 40. Each of control wires 50a, 50b, and 50c can be coupled to knots 44 of a respective controllably-expandable section 40. Once each respective control wire 50 is pulled, as shown, wire 50 releases all of knots 44 of the respective controllably-expandable section.
[0191] In the illustrated application, once control wire 50a has been pulled, and section 40 expands, a tissue anchor 32 or other attachment means can be used to anchor or attach sleeve 26 to the cardiac tissue at section 42. This sequential anchoring of sleeve 26 to the tissue immediately following the expansion of a first controllably-expandable section 40, but before expansion of a second controllably-expandable section 40 by control wire 50b, enables the operating physician to alternate between expansion and anchoring and enables the operating physician to control the amount of overall expansion of sleeve 26. Once a sufficient amount of sleeve 26 is anchored to annulus tissue 10, the physician can choose to keep the remaining controllably-expandable sections 40 in their compressed states. In such a manner, system 20 minimizes the likelihood of any excess sleeve 26 interfering with the cardiac valve. Additionally, with system 20, the physician does not need to measure the size of the annulus prior to positioning annuloplasty ring structure 222. In such a manner, structure 222 accommodates and fits all native annulus sizes.
[0192] Once the physician has positioned structure 222 along the annulus and has expanded any number of controllably-expandable sections 40, contracting member 30 is used to contract annuloplasty structure 222 independently of any remaining control wires 50 coupled to the body portion of structure 222. For some applications, contracting member 30 is coupled to and/or is part of an actuatable contracting mechanism or adjustment mechanism, for example, as described elsewhere herein and/or as described in US Patent Application Publication 2014/0309661 to Sheps et al., and/or in US Patent Application Publication 2015/0272734 to Sheps et al., which are incorporated herein by reference. Additionally, implantation of structure 222 can be done using any methods described in the '661 and/or '734 applications.
[0193]
[0194] Structure 252 comprises a one or more control wires 50. For some applications, structure 252 comprises a respective control wire 50 for each controllably-expandable section 40. Respective portions of control wire 50 are reversibly coupled directly to material of sleeve 26 at controllably-expandable section 40, at coupling points 254. Once control wire 50 is pulled, as shown, wire 50 actively pulls on the material of sleeve 26 in order to facilitate expansion of controllably-expandable section 40.
[0195] As shown in the illustrated application, once control wire 50 has been pulled, and section 40 expands, a tissue anchor 32 or other attachment means can be used to anchor or attach sleeve 26 to the cardiac tissue at section 42. This sequential anchoring of sleeve 26 to the tissue immediately following the expansion of a first controllably-expandable section 40, but before expansion of a second controllably-expandable section 40 by control wire 50, enables the operating physician to alternate between expansion and anchoring and enables the operating physician to control the amount of overall expansion of sleeve 26. Once a sufficient amount of sleeve 26 is anchored to the annulus, the physician can choose to keep the remaining controllably-expandable sections 40 in their compressed states. In such a manner, system 250 minimizes the likelihood of any excess sleeve 26 interfering with the cardiac valve. Additionally, with system 250, the physician does not need to measure the size of the annulus prior to positioning annuloplasty ring structure 252. In such a manner, structure 252 accommodates and fits all native annulus sizes.
[0196] Once the physician has positioned structure 252 along the annulus and has expanded any number of controllably-expandable sections 40, contracting member 30 is used to contract annuloplasty structure 252 independently of any remaining control wires 50 coupled to the body portion of structure 252. For some applications, contracting member 30 is coupled to and/or is part of an actuatable contracting mechanism or adjustment mechanism, for example, as described elsewhere herein and/or as described in US Patent Application Publication 2014/0309661 to Sheps et al., and/or in US Patent Application Publication 2015/0272734 to Sheps et al., which are incorporated herein by reference. Additionally, implantation of structure 252 can be done using any methods described in the '661 and/or '734 applications.
[0197]
[0198] Sleeve 426 can be manufactured such that sections 40 are biased such that each section 40 retains its folded shape. For example, during manufacture, each section 40 can be ironed, or otherwise set, so as to assume the folded shape. For some applications, as shown hereinbelow, each section 40 can be pulled open by a respective control wire coupled thereto. For some applications, each section 40 can be pulled open by pulling on a different section, e.g., an end, of sleeve 426. Structure 422 is delivered to the annulus in a shortened state, as shown in
[0199] In
[0200] For some applications, each section 42 is labeled with a radiopaque marker. For some applications, each section 42 is designated as an anchor-designated section.
[0201] In
[0202] In
[0203] This sequential anchoring of sleeve 426 to the tissue immediately following the expansion of a first controllably-expandable section 40a but before expansion of a second controllably-expandable section 40b enables the operating physician to alternate between expansion and anchoring and enables the operating physician to control the amount of overall expansion of sleeve 426. Once a sufficient amount of sleeve 426 is anchored to the annulus, the physician can choose to keep the remaining controllably-expandable sections 40c and 40d in their compressed states. In such a manner, system 420 minimizes the likelihood of any excess sleeve 426 interfering with the cardiac valve. Additionally, with system 420, the physician does not need to measure the size of the annulus prior to positioning annuloplasty ring structure 422. In such a manner, structure 422 accommodates and fits all native annulus sizes.
[0204] Sleeve 426 can comprise a braided fabric mesh, e.g., comprising polyethylene terephthalate, Dacron™, other materials, etc. Body portion 23 (e.g., sleeve 26) can be configured to be placed only partially around a cardiac valve annulus (i.e., to assume a C-shape), and, once anchored in place, to be contracted so as to circumferentially tighten the valve annulus. Optionally, the body portion can be configured to be placed entirely around the valve annulus. In order to tighten the annulus, the system 420 comprises an actuatable adjustment mechanism or contracting mechanism. The adjustment mechanism or contracting mechanism can be part of and/or coupled to one or more of the annuloplasty structure 422, a flexible elongate contracting member 30 that extends along sleeve 426, and/or another component of the system. Elongate contracting member 30 can comprise a wire, a ribbon, a rope, or a band, which can comprise a flexible and/or superelastic material, e.g., nitinol, polyester, stainless steel, or cobalt chrome. For some applications, the contracting member 30 comprises a radiopaque material. For some applications, contracting member 30 comprises a braided polyester suture (e.g., Ticron). For some applications, contracting member 30 is coated with polytetrafluoroethylene (PTFE). For some applications, contracting member 30 comprises a plurality of wires that are intertwined to form a rope structure. The actuatable adjustment mechanism or contraction mechanism can be configured in a variety of ways, such as in any of the ways described elsewhere herein with respect to other actuatable adjustment mechanisms and/or in other documents incorporated by reference.
[0205] Once the physician has positioned structure 422 along the annulus and has expanded any number of controllably-expandable sections 40, contracting member 30 is used to contract annuloplasty structure 422. For some applications, contracting member 30 is coupled to and/or is part of an actuatable contracting mechanism or adjustment mechanism, for example, as described elsewhere herein and/or as described in US Patent Application Publication 2014/0309661 to Sheps et al., and/or in US Patent Application Publication 2015/0272734 to Sheps et al., which are incorporated herein by reference. Additionally, implantation of structure 422 can be done using any methods described in the '661 and/or '734 applications.
[0206]
[0207] Any number of tissue anchors 32 or other attachment means can be used to anchor or attach structure 322 to the annulus of the valve. Once a sufficient amount of sleeve 326 is anchored to the annulus, the physician folds, or pushes, the excess portion 330 of sleeve 326 into the lumen of the portion of sleeve 326 that has already been anchored to the annulus, using a pushing tool 340. That is, the physician folds a second end portion of sleeve 326 toward a first end portion of sleeve 326. In such a manner, system 320 minimizes the likelihood of any excess sleeve 326 interfering with the cardiac valve. Additionally, with system 320, the physician does not need to measure the size of the annulus prior to positioning annuloplasty ring structure 322. In such a manner, structure 322 accommodates and fits all native annulus sizes.
[0208] For some applications a cutting tool (not shown) can be used to cut excess portion 330 of sleeve 326.
[0209] Sleeve 326 can comprise a braided fabric mesh, e.g., comprising polyethylene terephthalate, Dacron™, other materials, etc. Body portion 332 (e.g., sleeve 326) can be configured to be placed only partially around a cardiac valve annulus (i.e., to assume a C-shape), and, once anchored in place, to be contracted so as to circumferentially tighten the valve annulus. Optionally, the body portion can be configured to be placed entirely around the valve annulus. In order to tighten the annulus, the system 320 comprises an actuatable adjustment mechanism or contracting mechanism. The adjustment mechanism or contracting mechanism can be part of and/or coupled to one or more of the annuloplasty structure 322, a flexible elongate contracting member 30 that extends along sleeve 326, and/or another component of the system (e.g., a catheter, etc.). Elongate contracting member 30 can comprise a wire, a ribbon, a rope, or a band, which can comprise a flexible and/or superelastic material, e.g., nitinol, polyester, stainless steel, or cobalt chrome. For some applications, the contracting member 30 comprises a radiopaque material. For some applications, contracting member 30 comprises a braided polyester suture (e.g., Ticron). For some applications, contracting member 30 is coated with polytetrafluoroethylene (PTFE). For some applications, contracting member 30 comprises a plurality of wires that are intertwined to form a rope structure. The actuatable adjustment mechanism or contraction mechanism can be configured in a variety of ways, such as in any of the ways described elsewhere herein with respect to other actuatable adjustment mechanisms and/or in other documents incorporated by reference.
[0210] Once the physician has positioned structure 322 along the annulus and has pushed excess portion 330 within the lumen of the portion of sleeve 326 already anchored to the cardiac tissue, contracting member 30 is used to contract annuloplasty structure 322. For some applications, contracting member 30 is coupled to and/or is part of an actuatable contracting mechanism or adjustment mechanism, for example, as described elsewhere herein and/or as described in US Patent Application Publication 2014/0309661 to Sheps et al., and/or in US Patent Application Publication 2015/0272734 to Sheps et al., which are incorporated herein by reference. Additionally, implantation of structure 322 can be done using any methods described in the '661 and/or '734 applications.
[0211] In such a manner, system 320 facilitates delivering of an elongate structure or annuloplasty ring structure (e.g., structure 322, as shown) to the annulus in an elongate state, anchoring in part to the annulus, and then subsequently to the anchoring, shortening of the elongate structure while maintaining the body portion of the structure or annuloplasty ring structure intact (e.g., by not cutting or severing any portion of the body portion), and subsequently to the shortening, contracting of the structure or annuloplasty ring structure by contracting member 30 in order to contract and remodel the annulus of the patient. In such a manner, the pre-shortening of the structure or annuloplasty ring structure reduces the overall contraction force that is required in order to contract the structure or annuloplasty ring structure.
[0212] System 320, therefore, provides a method for (a) delivering to the annulus of the patient structure 322 while body portion 332 has a first longitudinal length L3 of 120-136 mm, (b) subsequently to the delivering, shortening body portion 332 to a second longitudinal length L4 of 40-68 mm independently of contracting member 30, while maintaining the entirety of annuloplasty body portion 332 intact (e.g., no part of portion 332 is cut or severed), and (c) subsequently to the shortening, remodeling the annulus by contracting body portion 332 using contracting member 30. This means that body portion 332 will only need to be contracted along a smaller length, i.e., length L4, rather than along a greater length L3, i.e., if excess portion 330 were not to be pushed within the lumen of sleeve 326. As such, pushing excess portion 330 within the lumen of sleeve 326 reduces the overall force needed to contract body portion 332 once anchored to the annulus.
[0213]
[0214] Optionally, deformable region 530 can comprise a super-elastic material, e.g., nitinol, which enables deformable region 530 to assume its shape. For some applications, the super-elastic material has shape-memory.
[0215] Any number of tissue anchors 32 or other attachment means can be used to anchor or attach structure 522 to the annulus of the valve using an anchor-delivery system or attachment system 550. In the illustrated application, anchor-delivery system 550 comprises a tube. While the tube of system 550 is disposed within at least the lumen of deformable region 530, deformable region 530 assumes a first, generally linear shape, as shown in
[0216] Sleeve 526 can comprise a braided fabric mesh, e.g., comprising polyethylene terephthalate, Dacron™, other materials, etc. Body portion 523 (e.g., sleeve 526) can be configured to be placed only partially around a cardiac valve annulus (i.e., to assume a C-shape), and, once anchored in place, to be contracted so as to circumferentially tighten the valve annulus. Optionally, the body portion can be configured to be placed entirely around the valve annulus. In order to tighten the annulus, system 520 comprises an actuatable adjustment mechanism or contracting mechanism. The adjustment mechanism or contracting mechanism can be part of and/or coupled to one or more of the annuloplasty structure 522, a flexible elongate contracting member 30 that extends along sleeve 526, and/or another component of the system (e.g., a catheter, etc.). Elongate contracting member 30 can comprise a wire, a ribbon, a rope, or a band, which can comprise a flexible and/or superelastic material, e.g., nitinol, polyester, stainless steel, or cobalt chrome. For some applications, the contracting member 30 comprises a radiopaque material. For some applications, contracting member 30 comprises a braided polyester suture (e.g., Ticron). For some applications, contracting member 30 is coated with polytetrafluoroethylene (PTFE). For some applications, contracting member 30 comprises a plurality of wires that are intertwined to form a rope structure. The actuatable adjustment mechanism or contraction mechanism can be configured in a variety of ways, such as in any of the ways described elsewhere herein with respect to other actuatable adjustment mechanisms and/or in other documents incorporated by reference.
[0217] Once the physician has positioned structure 522 along the annulus and allowed deformable region 530 to assume the deformed shape, contracting member 30 is used to contract annuloplasty structure 522. For some applications, contracting member 30 is coupled to and/or is part of an actuatable contracting mechanism or adjustment mechanism, for example, as described elsewhere herein and/or as described in US Patent Application Publication 2014/0309661 to Sheps et al., and/or in US Patent Application Publication 2015/0272734 to Sheps et al., which are incorporated herein by reference. Additionally, implantation of structure 522 can be done using any methods described in the '661 and/or '734 applications.
[0218] In such a manner, system 520 facilitates delivering of an elongate structure or annuloplasty ring structure (e.g., structure 522, as shown) to the annulus in an elongate state, anchoring in part to the annulus, and then subsequently to the anchoring, shortening of the elongate structure while maintaining the body portion of the structure or annuloplasty ring structure intact (e.g., by not cutting or severing any portion of the body portion), and subsequently to the shortening, contracting of the structure or annuloplasty ring structure by contracting member 30 in order to contract and remodel the annulus of the patient. In such a manner, the pre-shortening of the structure or annuloplasty ring structure reduces the overall contraction force that is required in order to contract the structure or annuloplasty ring structure.
[0219] System 520, therefore, provides a method for (a) delivering to the annulus of the patient structure 522 while body portion 523 has a first longitudinal length L5 of 122-130 mm, e.g., 125 mm (b) subsequently to the delivering, shortening body portion 523 to a second longitudinal length L6 of 90-129 mm, e.g., 100 mm, independently of contracting member 30, while maintaining the entirety of body portion or annuloplasty body portion 523 intact (e.g., no part of portion 523 is cut or severed), and (c) subsequently to the shortening, remodeling the annulus by contracting body portion 523 using contracting member 30. This means that body portion 523 will only need to be contracted along a smaller length, i.e., length L6, rather than along a greater length L5, i.e., if deformable region were not to be deformed. As such, allowing region 530 to deform reduces the overall force needed to contract body portion 523 once anchored to the annulus.
[0220] Reference is now made to
[0221] A first portion 650 of the plurality of interwoven fibers are oriented at an angle α (alpha) of 20-70 degrees, e.g., 45 degrees, with respect to a longitudinal axis 621 of body portion 623. A second portion 652 of the plurality of interwoven fibers are oriented at an angle β (beta) of 110-160 degrees, e.g., 135 degrees with respect to a longitudinal axis 621 of annuloplasty body portion 623. First and second portions 650 and 652 of interwoven fibers imparts increased longitudinal compressibility and/or stretchability to sleeve 626.
[0222] Sleeve 626 can comprise a braided fabric mesh, e.g., comprising polyethylene terephthalate, Dacron™, other materials, etc. Body portion 623 (e.g., sleeve 626) can be configured to be placed only partially around a cardiac valve annulus (i.e., to assume a C-shape), and, once anchored in place, to be contracted so as to circumferentially tighten the valve annulus. Optionally, the body portion can be configured to be placed entirely around the valve annulus. In order to tighten the annulus, the system comprises an actuatable adjustment mechanism or contracting mechanism. The adjustment mechanism or contracting mechanism can be part of and/or coupled to one or more of the annuloplasty structure 622, a flexible elongate contracting member 30 that extends along sleeve 626, and/or another component (e.g., catheter, etc.). Elongate contracting member 30 can comprise a wire, a ribbon, a rope, or a band, which can comprise a flexible and/or superelastic material, e.g., nitinol, polyester, stainless steel, or cobalt chrome. For some applications, the contracting member 30 comprises a radiopaque material. For some applications, contracting member 30 comprises a braided polyester suture (e.g., Ticron). For some applications, contracting member 30 is coated with polytetrafluoroethylene (PTFE). For some applications, contracting member 30 comprises a plurality of wires that are intertwined to form a rope structure. The actuatable adjustment mechanism or contraction mechanism can be configured in a variety of ways, such as in any of the ways described elsewhere herein with respect to other actuatable adjustment mechanisms and/or in other documents incorporated by reference.
[0223] Once the physician has positioned structure 622 along the annulus and has anchored or attached structure 622 to the annulus, contracting member 30 is used to contract annuloplasty structure 622. For some applications, contracting member 30 is coupled to and/or is part of an actuatable contracting mechanism or adjustment mechanism, for example, as described elsewhere herein and/or as described in US Patent Application Publication 2014/0309661 to Sheps et al., and/or in US Patent Application Publication 2015/0272734 to Sheps et al., which are incorporated herein by reference. Additionally, implantation of structure 622 can be done using any methods described in the '661 and/or '734 applications.
[0224] Reference is now made to
[0225] First longitudinal section 730 comprises flexible material comprising a plurality of interwoven fibers. A first portion 750 of the plurality of interwoven fibers are oriented at an angle α (alpha) of 20-70 degrees, e.g., 45 degrees, with respect to a longitudinal axis 721 of annuloplasty ring body portion 723. A second portion 752 of the plurality of interwoven fibers are oriented at an angle β (beta) of 110-160 degrees, e.g., 135 degrees with respect to a longitudinal axis 721 of annuloplasty ring body portion 723. First and second portions 750 and 752 of the interwoven fibers imparts increased longitudinal compressibility and/or stretchability to first longitudinal section 730.
[0226] Second longitudinal section 732 comprises flexible material comprising a plurality of interwoven fibers. A third portion 754 of the plurality of interwoven fibers are oriented at an angle γ (gamma) of 0-15 degrees, e.g., 0 degrees or 180 degrees, with respect to a longitudinal axis 721 of annuloplasty body portion 723. A fourth portion 756 of the plurality of interwoven fibers are oriented at an angle δ (delta) of 75-90 degrees, e.g., 90 degrees with respect to a longitudinal axis 721 of annuloplasty body portion 723. Third and fourth portions 754 and 756 of the interwoven fibers imparts increased strength, rigidity, and/or stability to second longitudinal section 732. Thus, each of second longitudinal sections 732 is designated for driving a respective tissue anchor 32 therethrough, i.e., sections 732 are anchor-designated sections.
[0227] Therefore, there is typically a trade-off between (i) strength, rigidity, and/or stability, and (ii) compressibility and/or stretchability. By providing both (i) anchor-designated sections 732 with increased strength, rigidity, and/or stability specifically where anchors will be anchored, and (ii) sections 730 with increased compressibility and/or stretchability specifically where anchors will not be anchored, structure 722 is provided with both (i) sufficient strength, rigidity, and/or stability for anchors 32 to be fastened thereto, and (ii) sufficient compressibility and/or stretchability for adapting to various annulus sizes.
[0228] Sleeve 726 can comprise a braided fabric mesh, e.g., comprising polyethylene terephthalate, Dacron™, other materials, etc. Body portion 723 (e.g., sleeve 726) can be configured to be placed only partially around a cardiac valve annulus (i.e., to assume a C-shape), and, once anchored in place, to be contracted so as to circumferentially tighten the valve annulus. Optionally, the body portion can be configured to be placed entirely around the valve annulus. In order to tighten the annulus, the system comprises an actuatable adjustment mechanism or contracting mechanism. The adjustment mechanism or contracting mechanism can be part of and/or coupled to one or more of the annuloplasty structure 722, a flexible elongate contracting member 30 that extends along sleeve 726, and/or another component (e.g., catheter, etc.). Elongate contracting member 30 can comprise a wire, a ribbon, a rope, or a band, which can comprise a flexible and/or superelastic material, e.g., nitinol, polyester, stainless steel, or cobalt chrome. For some applications, the contracting member 30 comprises a radiopaque material. For some applications, contracting member 30 comprises a braided polyester suture (e.g., Ticron). For some applications, contracting member 30 is coated with polytetrafluoroethylene (PTFE). For some applications, contracting member 30 comprises a plurality of wires that are intertwined to form a rope structure. The actuatable adjustment mechanism or contraction mechanism can be configured in a variety of ways, such as in any of the ways described elsewhere herein with respect to other actuatable adjustment mechanisms and/or in other documents incorporated by reference.
[0229] Once the physician has positioned structure 722 along the annulus and has anchored or attached structure 722 to the annulus, contracting member 30 is used to contract annuloplasty structure 722. For some applications, contracting member 30 is coupled to and/or is part of an actuatable contracting mechanism or adjustment mechanism, for example, as described elsewhere herein and/or as described in US Patent Application Publication 2014/0309661 to Sheps et al., and/or in US Patent Application Publication 2015/0272734 to Sheps et al., which are incorporated herein by reference. Additionally, implantation of structure 722 can be done using any methods described in the '661 and/or '734 applications.
[0230] Thus, first longitudinal sections 730 have a greater degree of compressibility than second longitudinal sections 732. As such, first longitudinal sections 730 reduce the overall compressible force to body portion 723 by contracting member 30 during contraction of structure 722.
[0231] Reference is now made to
[0232] As shown in
[0233] Once the physician has positioned structure 822 along the annulus and has anchored or attached structure 822 to the annulus, contracting member 30 is used to contract annuloplasty structure 822. For some applications, contracting member 30 is coupled to and/or is part of an actuatable contracting mechanism or adjustment mechanism, for example, as described elsewhere herein and/or as described in US Patent Application Publication 2014/0309661 to Sheps et al., and/or in US Patent Application Publication 2015/0272734 to Sheps et al., which are incorporated herein by reference. Additionally, implantation of structure 822 can be done using any methods described in the '661 and/or '734 applications.
[0234] Reference is now made to
[0235] Each one of first sections 932 defines a compressible section having compressible-section wall having a first thickness T1 of 0.05-0.1 mm, e.g., 0.07 mm. Each one of second sections 930 defines an anchor-designated section having an anchor-designated wall having a second thickness T2 of 0.15-0.2 mm, e.g., 0.18 mm. Second thickness T2 is greater than first thickness T1 and second thickness T2 is such so as to impart rigidity and/or stability to the respective sections 930 of sleeve 926 though which a respective anchor 32 is deployed. For some applications, each section 930 is labeled with a radiopaque marker.
[0236] First longitudinal sections 932, due to their respective thickness, have a greater degree of compressibility than second longitudinal sections 930. As such, first longitudinal sections 932 reduce the overall compressible force to body portion 923 by contracting member 30 during contraction of structure 922.
[0237] Sleeve 926 can comprise a braided fabric mesh, e.g., comprising polyethylene terephthalate, Dacron™, other materials, etc. Body portion 923 (e.g., sleeve 926) can be configured to be placed only partially around a cardiac valve annulus (i.e., to assume a C-shape), and, once anchored in place, to be contracted so as to circumferentially tighten the valve annulus. Optionally, the body portion can be configured to be placed entirely around the valve annulus. In order to tighten the annulus, the system comprises an actuatable adjustment mechanism or contracting mechanism. The adjustment mechanism or contracting mechanism can be part of and/or coupled to one or more of the annuloplasty structure 922, a flexible elongate contracting member 30 that extends along sleeve 926, and/or another component (e.g., catheter, etc.). Elongate contracting member 30 can comprise a wire, a ribbon, a rope, or a band, which can comprise a flexible and/or superelastic material, e.g., nitinol, polyester, stainless steel, or cobalt chrome. For some applications, the contracting member 30 comprises a radiopaque material. For some applications, contracting member 30 comprises a braided polyester suture (e.g., Ticron). For some applications, contracting member 30 is coated with polytetrafluoroethylene (PTFE). For some applications, contracting member 30 comprises a plurality of wires that are intertwined to form a rope structure. The actuatable adjustment mechanism or contraction mechanism can be configured in a variety of ways, such as in any of the ways described elsewhere herein with respect to other actuatable adjustment mechanisms and/or in other documents incorporated by reference.
[0238] Once the physician has positioned structure 922 along the annulus and has anchored or attached structure 922 to the annulus, contracting member 30 is used to contract annuloplasty structure 922. For some applications, contracting member 30 is coupled to and/or is part of an actuatable contracting mechanism or adjustment mechanism, for example, as described elsewhere herein and/or as described in US Patent Application Publication 2014/0309661 to Sheps et al., and/or in US Patent Application Publication 2015/0272734 to Sheps et al., which are incorporated herein by reference. Additionally, implantation of structure 922 can be done using any methods described in the '661 and/or '734 applications.
[0239] Reference is now made to
[0240] In
[0241] In
[0242] In
[0243]
[0244]
[0245] For some applications, the annuloplasty structure is anchored to the annulus tissue only once the structure has been shortened in accordance with the decision of the operating physician (step 1230). Optionally, the annuloplasty structure is shortened alternatingly with anchoring, as per step 1240. That means, the annuloplasty structure can be shortened in part, then anchored to the annulus tissue using a first tissue anchor. Subsequently, the annuloplasty structure can be shortened in part, again, then anchored to the annulus tissue using a second tissue anchor. Finally, in step 1250, the annulus is remodeled by contracting the annuloplasty structure using the contracting member 30.
[0246] Reference is now made to
[0247]
[0248] For some applications, the annuloplasty structure is anchored to the annulus tissue only once the structure has been expanded in accordance with the decision of the operating physician (step 1330). Optionally, the annuloplasty structure is expanded alternatingly with anchoring, as per step 1340. That means, the annuloplasty structure can be expanded in part, then anchored to the annulus tissue using a first tissue anchor. Subsequently, the annuloplasty structure can be expanded in part, again, then anchored to the annulus tissue using a second tissue anchor. Finally, in step 1350, the annulus is remodeled by contracting the annuloplasty structure using the contracting member 30.
[0249] Reference is now made to
[0250] Reference is now made to
[0251] In some applications, each window 1628, and each compressible section 1624 has a longest dimension L7 of 12-16 mm, e.g., 14 mm.
[0252] Reference is now made to
[0253] Covers 1630, due to their respective interwoven fibers, have a greater degree of compressibility and/or stretchability than anchor-designated sections 1625. As such, windows 1628 and covers 1630 reduce the overall compressible force to body portion 1623 by contracting member 30 during contraction of structure 1622.
[0254] Reference is now made to
[0255] Covers 1630, due to their respective thickness, have a greater degree of compressibility than anchor-designated sections 1625. As such, windows 1628 and covers 1630 reduce the overall compressible force to body portion 1623 by contracting member 30 during contraction of structure 1622.
[0256] Reference is again made to
[0257] Once the physician has positioned structure 1622 along the annulus and has anchored or attached structure 1622 to the annulus, contracting member 30 is used to contract annuloplasty structure 1622. For some applications, contracting member 30 is coupled to and/or is part of an actuatable contracting mechanism or adjustment mechanism, for example, as described elsewhere herein and/or as described in US Patent Application Publication 2014/0309661 to Sheps et al., and/or in US Patent Application Publication 2015/0272734 to Sheps et al., which are incorporated herein by reference. Additionally, implantation of structure 922 can be done using any methods described in the '661 and/or '734 applications.
[0258] Reference is now made to
[0259] Structure 1722 is provided comprising any number of linking segments 1730 coupled to primary body portion 1723 such that structure 1722 can be delivered to the annulus of the patient in an elongate state and, subsequently, any number of linking segments 1730 can be decoupled from primary body portion 1723. Once a sufficient amount of structure 1722 (i.e., primary body portion 1723 and any number of linking segments 1730) is anchored to annulus tissue 10, the physician can choose to decouple and remove from the patient's body the remaining linking segments 1730. In such a manner, system 1700 minimizes the likelihood of any excess sleeve 1726 interfering with the cardiac valve. Additionally, with system 1700, the physician does not need to measure the size of the annulus prior to positioning annuloplasty ring structure 1722. In such a manner, structure 1722 accommodates and fits all native annulus sizes.
[0260] Primary body portion 1723 as well as linking segments 1730 comprise flexible sleeve 1726.
[0261] Sleeve 1726 can comprise a braided fabric mesh, e.g., comprising polyethylene terephthalate, e.g., Dacron™. Body portion 1723 (e.g., sleeve 1726) can be configured to be placed only partially around a cardiac valve annulus (i.e., to assume a C-shape), and, once anchored in place, to be contracted so as to circumferentially tighten the valve annulus. Optionally, the body portion can be configured to be placed entirely around the valve annulus. In order to tighten the annulus, the system comprises an actuatable adjustment mechanism or contracting mechanism. The adjustment mechanism or contracting mechanism can be part of and/or coupled to one or more of the annuloplasty structure 1722, a flexible elongate contracting member 30 that extends along sleeve 1726, and/or another component. Elongate contracting member 30 can comprise a wire, a ribbon, a rope, or a band, which can comprise a flexible and/or superelastic material, e.g., nitinol, polyester, stainless steel, or cobalt chrome. For some applications, the contracting member 30 comprises a radiopaque material. For some applications, contracting member 30 comprises a braided polyester suture (e.g., Ticron). For some applications, contracting member 30 is coated with polytetrafluoroethylene (PTFE). For some applications, contracting member 30 comprises a plurality of wires that are intertwined to form a rope structure. The actuatable adjustment mechanism or contraction mechanism can be configured in a variety of ways, such as in any of the ways described elsewhere herein with respect to other actuatable adjustment mechanisms and/or in other documents incorporated by reference.
[0262] Contracting member 30 extends along a longitudinal length of primary body portion 1723 as well as along each of linking segments 1730. Contracting member 30 can be used to contract primary body portion 1723 as well as linking segments 1730 along a longitudinal axis 1721 of structure 1722.
[0263] A first end, e.g., a proximal end of primary body portion 1723 can comprise a first coupling 1750. A second coupling 1752 can be coupled to a first end, e.g., a distal end, of a first linking segment 1730a that is disposed adjacent to first coupling 1750 of the first end of primary body portion 1723. First and second couplings 1750 and 1752 are shaped and configured so as to mate with each other.
[0264] A third coupling (e.g., another coupling 1750) can be coupled to a second end, e.g., a proximal end, of first linking segment 1730a. A fourth coupling (e.g., another coupling 1752) can be coupled to a first end (e.g., a distal end) of a second linking segment 1730b that is disposed adjacent to first linking segment 1730a.
[0265] First coupling 1750 is shaped and configured so as to define a first lumen and comprises one or more radially-moveable projections 1751. Second coupling 1752 is shaped and configured so as to define a second lumen and a negative space 1753 shaped and configured so as to receive one or more radially-moveable projections 1751.
[0266] For some applications, radially-moveable projection 1751 of first coupling 1750 comprises a single, circular projection and negative space 1753 of second coupling 1752 is shaped and configured so as to define a single, circular groove.
[0267] For some applications, radially-moveable projections 1751 are biased to collapse radially inwardly in an absence of force applied thereto. For some applications, radially-moveable projections 1751 are not biased to collapse radially inwardly, and are moveable in response to a force applied thereto. For example, the walls defining negative space 1753 of second coupling 1752 are shaped and configured so as to enable slidable decoupling of the one or more projections 1751 in one direction, in response to a force applied to linking segment 1730, e.g., a pulling force applied to linking segment 1730.
[0268] System 1700 comprises a decoupling-prevention element 1740, as shown in
[0269] For some applications, decoupling-prevention element 1740 comprises an elongate tube 1742. The external surface of tube 1742 is sized so as to rest against or push against one or more projections 1751 so as to maintain projections 1751 within negative space 1753 and prevent decoupling of first and second couplings 1750 and 1752.
[0270] For applications in which one or more projections 1751 are biased to move radially inward, the external surface of tube 1742 of decoupling-prevention element 1740 pushes against one or more projections 1751 of first coupling 1750 and maintains projections 1751 within negative space 1753 of second coupling 1752 in order to prevent decoupling of first and second couplings 1750 and 1752 while a portion of elongate tube 1742 passes through the first and second lumens of first and second couplings 1750 and 1752, respectively.
[0271] For some applications, tube 1742 of decoupling-prevention element 1740 comprises a tube of an anchor-delivery system 1743. For some applications, anchor-delivery system 1743 comprises the deployment manipulator, anchor driver, and deployment element, as described in US Patent Application Publication 2014/0309661 to Sheps et al., and/or in US Patent Application Publication 2015/0272734 to Sheps et al., which are incorporated herein by reference.
[0272] For some applications, decoupling-prevention element 1740 comprises an overtube 1744, e.g., a steerable catheter, which is used to deliver annuloplasty structure 1722. Overtube 1744 has an inner diameter sized so as to maintain coupling of couplings 1750 and 1752 when a portion of overtube 1744 surrounds first and second couplings 1750 and 1752.
[0273] For some applications, decoupling-prevention element 1740 comprises contracting member 30. Since contracting member 30 extends along, e.g., threaded along, primary body portion 1723 and linking segments 1730, contracting member 30 maintains coupling of first and second couplings 1750 and 1752.
[0274]
[0275] Once primary body portion 1723 is anchored to cardiac tissue 10, anchor-delivery system 1743 is moved in order to position first linking segment 1730a appropriately at cardiac tissue 10 to be anchored thereto. As shown in
[0276] For applications in which one or more projections 1751 of first coupling 1750 is biased to move radially inward, in the absence of decoupling-prevention element 1740, projections 1751 move radially inward, as shown in
[0277] It is to be noted that for some applications, one or more projections 1751 of first coupling 1750 are not biased to move radially inward, and are only moveable in response to a force applied thereto, e.g., a pulling force applied to segment 1730a from a proximal direction. In such applications, one or more projections 1751 do not move radially inwardly in the absence of the pushing force applied thereto by the external surface of tube 1742.
[0278] In either application, contracting member 30 maintains coupling of linking segment 1730a and primary body portion 1723 even though tube 1742 is not disposed within the respective elements of couplings 1750 and 1752 and, as a result, one or more projections 1751 are moveable from within negative space 1753. In such a manner, contracting member 30 functions as decoupling-prevention element 1740. Additionally, since segment 1730a is anchored to tissue 10, coupling of segment 1730 and primary body portion 1723 is maintained.
[0279] In
[0280] As noted hereinabove with reference to
[0281] Additionally, as noted in
[0282]
[0283] As noted hereinabove with reference to
[0284] Additionally, as noted in
[0285] In either application, third linking segments 1730c can be decoupled from second linking segment following radial movement of one or more projections 1751 of coupling 1750 of second linking segment 1730b from within negative space 1753 of coupling 1752 of third linking segment 1730c.
[0286] As shown, third linking segment 1730c, as well as any other additional linking segments 1730 disposed proximally to third linking segment 1730c, are moved proximally away from primary body portion 1723 and first and second linking segments 1730a and 1730b coupled to cardiac tissue. As shown, third linking segment 1730c, as well as any other additional linking segments 1730 disposed proximally to third linking segment 1730c are pulled along contracting member 30.
[0287]
[0288] Once the physician has positioned structure 1722 along the annulus and has removed any number of linking segments 1730, contracting member 30 can be used to contract annuloplasty structure 1722, for example, by actuating contracting mechanism 1040, which comprises and/or is coupled to contracting member 30 as described in US Patent Application Publication 2014/0309661 to Sheps et al., and/or in US Patent Application Publication 2015/0272734 to Sheps et al., which are incorporated herein by reference. Additionally, implantation of structure 1722 can be done using any methods described in the '661 and/or '734 applications.
[0289] Reference is now made to
[0290] Sleeve 1826 can comprise a braided fabric mesh, e.g., comprising polyethylene terephthalate, Dacron™, other materials, etc. Body portion 1823 (e.g., sleeve 1826) can be configured to be placed only partially around a cardiac valve annulus (i.e., to assume a C-shape), and, once anchored in place, to be contracted so as to circumferentially tighten the valve annulus. Optionally, the body portion can be configured to be placed entirely around the valve annulus (e.g., a full or closed ring). In order to tighten the annulus, the system comprises an actuatable adjustment mechanism or contracting mechanism. The adjustment mechanism or contracting mechanism can be part of and/or coupled to one or more of the annuloplasty structure 1820, a flexible elongate contracting member 30 that extends along sleeve 1826, and/or another component. Elongate contracting member 30 can comprise a wire, a ribbon, a rope, or a band, which can comprise a flexible and/or superelastic material, e.g., nitinol, polyester, stainless steel, or cobalt chromium. For some applications, the contracting member 30 comprises a radiopaque material. For some applications, contracting member 30 comprises a braided polyester suture (e.g., Ticron). For some applications, contracting member 30 is coated, such as with polytetrafluoroethylene (PTFE) or another polymer. For some applications, contracting member 30 comprises a plurality of wires that are intertwined to form a rope structure. The actuatable adjustment mechanism or contraction mechanism can be configured in a variety of ways, such as in any of the ways described elsewhere herein with respect to other actuatable adjustment mechanisms and/or in other documents incorporated by reference.
[0291] For some applications, sleeve 1826 is labeled with one or more radiopaque markers. Sleeve 1826 can comprise a flexible sleeve 1826 shaped and configured so as to define a lumen therethrough.
[0292] In
[0293] In
[0294] A respective length of each of first and second segments 1822 and 1824 can be controlled by the operating physician.
[0295] For some applications, the entire body portion 1823 has a gradually increasing flexibility from a distal end of body portion 1823 toward a proximal end of body portion 1823. That is, second segment 1824 can be longer and/or assume a greater percentage of body portion 1823 than as shown in
[0296] In the context of the present application, including the claims “proximal” refers to a part of the structure that is closer to the orifice through which the structure was introduced and “distal” refers to a part of the structure that is farther from the orifice through which the structure was introduced.
[0297] Additionally, for some applications, the increased stretchability of segment 1824 imparts increased compressibility to segment 1824. For example, body portion 1823 can be delivered to the heart in an elongate state, anchoring in part to the annulus, and then subsequently to the anchoring, shortening of the elongate structure (e.g., by compressing) in real time during the implantation procedure while maintaining the body portion of the structure or annuloplasty ring structure intact (e.g., by not cutting or severing any portion of the body portion), and subsequently to the shortening, contracting of the structure or annuloplasty ring structure by contracting member 30 in order to contract and remodel the annulus of the patient. For example, for some applications, after having fixed first segment 1822 to a first length of tissue of the annulus, it may become apparent to the physician that the length of path of the remaining tissue of the annulus is shorter than initially anticipated. With structure 1820 having segment 1824 with increased compressibility, the physician can the compress the remaining sections of second segment 1824 in order to accommodate the length of the path of the remaining tissue of the annulus.
[0298] Once the physician has fixed (e.g., typically by anchoring with anchor 32 and/or fastening with some other attachment means) first segment 1822 to the annulus, the physician subsequently stretches second segment 1824 in order to accommodate the remaining portions of the annulus to which structure 1820 has not yet been anchored. For example, for some applications, after having fixed first segment 1822 to a first length of tissue of the annulus, it may become apparent to the physician that the length of path of the remaining tissue of the annulus is longer than initially anticipated. With structure 1820 having segment 1824 with increased stretchability, the physician can the stretch second segment 1824 in order to accommodate the length of the path of the remaining tissue of the annulus. Subsequently to the stretching of second segment 1824, second segment 1824 is fixed to the annulus (e.g., one or more anchors 32 are deployed through sleeve 1826 of second segment 1824 in order to fix second segment 1824 to the annulus). In such a manner, a shorter annuloplasty structure can be delivered to the annulus and only stretched to a longer length once initially anchored to the annulus. As such, structure 1820 comprises a partially-stretchable, or partially-elastic structure 1820. For some applications, as body segment 1824 of body portion 1823 is stretched, a diameter of segment 1824 incrementally and gradually decreases.
[0299] As shown in
[0300] Since first segment 1822 has a degree of stretchability that is lower than second segment 1824, first segment 1822 typically but not necessarily has a D1 greater than a diameter D2 of second segment 1824 following stretching, and typically before contraction of structure 1820.
[0301] For some applications, the diameter of segment 1824 does not decrease following stretching. In such applications, the diameter of segment 1824 remains the same or similar to the diameter of segment 1822. For some applications, only the inner diameter may be reduced in response to the stretching of segment 1824. For some applications, only the outer diameter may be reduced in response to the stretching of segment 1824. For either of these applications, appropriate materials can be used which help to control the diameter of a given section of structure 1820 responsively to the application of a pulling, stretching, or compressing force. These appropriate materials also help to control a thickness of the wall of sleeve 1826.
[0302] Typically, second segment 1824 is, overall, more stretchable than first segment 1822. For some applications, second segment 1824 is homogenous throughout. That means, that the entire segment 1824 is stretchable in equal measure along the entire length of segment 1824. For some applications, second segment 1824 can have sections that are more stretchable and sections which are less stretchable. For such applications, second segment 1824 can have increasing stretchability along its length, or, second segment 1824 can have sections of variable stretchability which alternate along the length of second segment 1824.
[0303] As shown by way of illustration and not limitation in
[0304] Although
[0305] Reference is now made to
[0306] That is, for a method in which structure 1820 is implanted, first segment 1822 can be implanted by driving an anchor 32 through sleeve 1826 as shown in
[0307] Since second segment 1824 has increased flexibility, (1) a smaller length of sleeve 1826 can be released from delivery system 1050 incrementally in order to span the distance between attachment means/anchors 32 used to fix second segment 1824, then (2) a length of sleeve 1824 can be released from delivery system 1050 in order to span the same distance between attachment means/anchors 32 of first segment 1822.
[0308] That is, if the physician stretches sleeve 1826 at section 1829 of second segment 1824 to the span same distance between each attachment means/anchor 32, a smaller length of sleeve 1826 is released from delivery system 1050 prior to stretching between each anchor 32 in second segment 1824 than the length of sleeve 1826 is released from delivery system 1050 in order to span the distance between anchors 32 in first segment 1822.
[0309] For some applications, the stretching of segment 1824 straightens sleeve 1826 prior to anchoring of sleeve 1826. This straightening of sleeve 1826 by stretching advantageously lowers the likelihood of folding of sleeve 1826 in the anchoring region, thereby minimizing interference of any folds of sleeve 1826 with anchors 32.
[0310] It is to be further noted, that even though sleeve 1826 is stretched at second segment 1824, the elastic force of second segment 1824 (i.e., the force exerted by sleeve 1826 in order to return to its original length following anchoring of segment 1824) can be selected and/or configured to be insufficiently strong to contract the annulus. Thereby, annuloplasty is only achieved when sleeve 1826 is intentionally contracted by the physician, e.g., using contracting member 30. That is, the elastic force of second segment 1824 is not strong enough to contract second segment 1824 enough that it will affect tissue 10 to which second segment 1824 is coupled.
[0311] Reference is again made to
[0312] Once the physician has positioned structure 1820 along the annulus and has expanded segment 1824, contracting member 30 is used to contract annuloplasty structure 1820. For some applications, contracting member 30 is coupled to an actuatable contracting mechanism as described in US Patent Application Publication 2014/0309661 to Sheps et al., and/or in US Patent Application Publication 2015/0272734 to Sheps et al., which are incorporated herein by reference. Additionally, implantation of structure 1820 can be done using any methods described in the '661 and/or '734 applications.
[0313]
[0314] Structure 1922 comprises one or more (e.g., two as shown by way of illustration and not limitation) telescoping segments 1930a and 1930b. It is to be noted that structure 1922 can comprise any number of telescoping segments 1930 having any length as determined by a physician. For example, for some applications, all segments 1930 can have the same length. For other applications, segments 1930 can have a variable length. Structure 1922 can be delivered to the heart in a configuration in which telescoping segment 1930b is disposed at least in part within a lumen of telescoping segment 1930a, and telescoping segment 1930a is disposed at least in part within the lumen of sleeve 1926. Telescoping segments 1930a and 1930b can be moveable, or slidable, along a longitudinal axis 21 of body portion 1912.
[0315] A proximal end of sleeve 1926 comprises a coupling element 1934 which is configured to engage and become coupled to a coupling element 1932 at a distal end of telescoping segment 1930a. A proximal end of telescoping segment 1930a comprises a coupling element 1934 which is configured to engage and become coupled to a coupling element 1932 at a distal end of telescoping segment 1930b. For some applications, coupling elements 1932 and 1934 comprise hook-and-loop fasteners. For some applications, coupling elements 1932 and 1934 comprise magnets. Coupling elements 1932 and 1934 can comprise ring-shaped coupling elements which provide an unobstructed passage through the lumen of the entire structure 1922. Coupling elements 1932 and 1934 are coupled together typically following movement of the telescoping segment 1930 into its final position.
[0316] For some applications, telescoping segments 1930 comprise the same material as sleeve 1926. For some applications telescoping segments 1930 comprise material that is different from the material of sleeve 1826. For some applications, telescoping segments 1930 can have a wall thickness that is lower than the wall thickness of sleeve 1826.
[0317] Annuloplasty structure 1922 can comprise any annuloplasty structure or annuloplasty ring structure described herein with reference to
[0318] Sleeve 1926 and telescoping segments 1930 can comprise a braided fabric mesh, e.g., comprising polyethylene terephthalate, Dacron™, other materials, etc. Sleeve 1926 and telescoping segments 1930 can be configured to be placed only partially around a cardiac valve annulus (i.e., to assume a C-shape), and, once anchored in place, to be contracted so as to circumferentially tighten the valve annulus. Optionally, the ring structure can be configured to be placed entirely around the valve annulus (e.g., a full or closed ring). In order to tighten the annulus, the system comprises an actuatable adjustment mechanism or contracting mechanism. The adjustment mechanism or contracting mechanism can be part of and/or coupled to one or more of the annuloplasty structure 1922, a flexible elongate contracting member 30 that extends along sleeve 1926 and telescoping segments 1930, and/or another component. Elongate contracting member 30 can comprise a wire, a ribbon, a rope, or a band, which can comprise a flexible and/or superelastic material, e.g., nitinol, polyester, stainless steel, or cobalt chrome. For some applications, the contracting member 30 comprises a radiopaque material. For some applications, contracting member 30 comprises a braided polyester suture (e.g., Ticron). For some applications, contracting member 30 is coated, such as with polytetrafluoroethylene (PTFE) or another polymer. For some applications, contracting member 30 comprises a plurality of wires that are intertwined to form a rope structure. The actuatable adjustment mechanism or contraction mechanism can be configured in a variety of ways, such as in any of the ways described elsewhere herein with respect to other actuatable adjustment mechanisms and/or in other documents incorporated by reference.
[0319] For some applications, sleeve 1926 and telescoping segments 1930 are labeled with one or more radiopaque markers. Typically, sleeve 1926 and telescoping segments 1930 comprises a flexible sleeve 1926 shaped and configured so as to define a lumen therethrough.
[0320] An anchor-delivery system 1940 or other attachment system can be used to anchor or attach a first segment 1914 of annuloplasty body portion 1912 of annuloplasty structure 1922, for example, by deploying one or more tissue anchors 32 through sleeve 1926 and into annulus tissue 10, from within a lumen of sleeve 1926. Techniques for deploying anchors 32 through sleeve 1926 can be practiced in combination with techniques described in WO 2013/069019 to Sheps, which is incorporated herein by reference.
[0321] As shown, body portion 1912 comprises (1) first segment 1912, and (2) a second segment 1916 comprising telescoping segments 1930. For some applications, anchor-delivery system 1940 can reversibly engage and reversibly grip to a portion of telescoping segments 1930 during the pulling and moving of telescoping segment 1930.
[0322] Any number of tissue anchors 32 or other fastening or attachment means can be used to anchor or attach structure 1922 to the annulus of the valve. In some embodiments, once a sufficient amount of first segment 1914 of body portion 1912 is anchored/attached to the annulus, the physician pulls and expands telescoping segment 1930a from within the lumen of sleeve 1926 using system 1940. Once telescoping segment 1930a has been pulled from within the lumen of sleeve 1926, it is anchored/attached to annulus tissue 10 using an attachment means/tissue anchor 32, as shown. The physician then pulls and expands telescoping segment 1930b from within the lumen of telescoping segment 1930a using system 1940. Once telescoping segment 1930b has been pulled from within the lumen of telescoping segment 1930a, it can be anchored/attached to annulus tissue 10 using an attachment means/tissue anchor 32, as shown. In such a manner, system 1900 minimizes the likelihood of any excess sleeve 1926 interfering with the cardiac valve. Additionally, with system 1900, the physician does not need to measure the size of the annulus prior to positioning annuloplasty ring structure 1922. In such a manner, structure 1922 accommodates and fits all native annulus sizes.
[0323] First segment 1914 can be designated for implantation between the vicinity of the anterolateral commissure and roughly P2, while second segment 1916 can be designated for implantation between roughly P2 and the posterolateral commissure. Telescoping segments 1930 can be located at any part of body portion 1912.
[0324] Once the physician has positioned structure 1922 along the annulus and has secured telescoping segments 1930, contracting member 30 is used to contract annuloplasty structure 1922. For some applications, contracting member 30 is coupled to an actuatable contracting mechanism as described in US Patent Application Publication 2014/0309661 to Sheps et al., and/or in US Patent Application Publication 2015/0272734 to Sheps et al., which are incorporated herein by reference. Additionally, implantation of structure 1820 can be done using any methods described in the '661 and/or '734 applications.
[0325] Reference is made to
[0326] Annuloplasty structure 2020 (e.g., body portion 2023) comprises a tubular wall 2025 that defines a lumen along body portion 2023. That is, the lumen is defined along a longitudinal axis of elongate annuloplasty structure 2020. Wall 2025 comprises a sleeve 2026 and a helical member 2028. Sleeve 2026 can comprise a braided fabric mesh, e.g., comprising polyethylene terephthalate, Dacron™, other materials, etc. Body portion 2023 (e.g., wall 2025, such as sleeve 2026) can be configured to be placed only partially around a cardiac valve annulus (i.e., to assume a C-shape), and, once anchored in place, to be contracted so as to circumferentially tighten the valve annulus. Optionally, the body portion can be configured to be placed entirely around the valve annulus (e.g., a full or closed ring). For some applications, body portion 2023 (e.g., sleeve 2026) is labeled with one or more radiopaque markers, e.g., as described hereinabove, mutatis mutandis.
[0327] Helical member 2028 defines a plurality of helical turns extending in a helical path along and around the lumen of body portion 2023. Helical member 2028 is coupled to sleeve 2026. For example, helical member 2028 (e.g., parts thereof, or the entirety thereof) can be stitched or glued to sleeve 2026. Structure 2020 is shown with helical member 2028 being disposed inside of sleeve 2026, but the helical member can optionally be disposed outside of the sleeve. For some applications, the helical member can be embedded within the sleeve.
[0328] Many other annuloplasty structures described herein are described as being anchorable to tissue by anchors 32 being driven through the sleeve and into the tissue. Therefore, in some applications, such sleeves are configured to be sufficiently strong to support the resulting forces at the point of anchoring (e.g., at the point at which the anchor pierces the sleeve). As described hereinabove (e.g., with reference to
[0329] For some applications, helical member 2028 comprises a polymer. For some applications, helical member 2028 is metallic. For some applications, helical member 2028 comprises a shape memory material. For some applications, helical member 2028 comprises a fabric.
[0330] Helical member 2028 allows annuloplasty structure 2020 to be implanted relatively compressed for a relatively small annulus, with the helical member having a relatively small helix pitch (
[0331] For some other annuloplasty structures described herein, contracting member 30 extends along the body portion of the annuloplasty structure by weaving along the sleeve of the annuloplasty structure. In contrast, due to particular nature of sleeve 2026, for annuloplasty structure 2020 contracting member 30 extends through the lumen of body portion 2023, i.e., radially inward from helical member 2028.
[0332]
[0333] For some applications, and as shown in
[0334] For some applications, every helical turn of helical member 2028 is secured to the tissue by a respective anchor 32 (e.g., as shown in
[0335] Subsequent to its anchoring to the annulus, annuloplasty structure 2020 is contracted to reduce the size of the annulus, e.g., as described hereinabove, mutatis mutandis. Helical member 2028 and sleeve 2026 also facilitate this, with the helix pitch of the helical member becoming smaller during contraction.
[0336] For some applications, and as shown, system 2000 comprises a tool 2012 that facilitates delivery and/or anchoring of annuloplasty structure 2020. For some applications, anchor driver 2052 is a component of tool 2012. For some applications, tool 2012 comprises an anchor channel 2018 that extends into (and often through) the lumen of body portion 2023. For such applications, annuloplasty structure 2020 is typically delivered with channel 2018 already in place. Each anchor 32 is advanced into and through the lumen of body portion 2023 by being advanced through channel 2018. The anchor is typically anchored by advancing the anchor out of the distal opening of the channel and through the part of wall 2025 that is directly in front of the distal opening. After each part of body portion 2023 is anchored, a subsequent part of the body portion is advanced off of channel 2018 (e.g., by retracting channel 2018 with respect to the body portion), and that subsequent part is then anchored.
[0337] Control of this advancement can be facilitated by cooperation between channel 2018 and helical portion 2023. For example, when moving channel 2018 to the next tissue site to which annuloplasty structure 2020 is to be anchored, the resulting tension on body portion 2023 can tighten helical member 2028 around the channel, thereby gripping the channel, and increasing control over the advancement of the body portion off of the channel. For some applications, tool 2012 comprises a protrusion 2016 that extends radially outward from channel 2018, and engages helical member 2028, inhibiting the helical turn with which it engages from sliding off of the channel (
[0338] For some applications, protrusion 2016 is movable with respect to channel 2018, thereby providing a further degree of adjustability and/or control over the advancement of body portion 2023 off of the channel. For example, and as shown in
[0339] Reference is now made to
[0340] Reference is again made to
[0341] Reference is again made to
[0342] Reference is again made to
[0343] Additionally, the scope herein includes applications described in one or more of the following: [0344] U.S. patent application Ser. No. 12/435,291 to Maisano et al., entitled, “Adjustable repair chords and spool mechanism therefor,” filed on May 4, 2009, which issued as U.S. Pat. No. 8,147,542; [0345] U.S. patent application Ser. No. 12/437,103 to Zipory et al., entitled, “Annuloplasty ring with intra-ring anchoring,” filed on May 7, 2009, which issued as U.S. Pat. No. 8,715,342; [0346] U.S. patent application Ser. No. 12/548,991 to Maisano et al., entitled, “Implantation of repair chords in the heart,” filed on Aug. 27, 2009, which issued as U.S. Pat. No. 8,808,368; [0347] PCT Patent Application PCT/IL2009/001209 to Cabiri et al., entitled, “Adjustable annuloplasty devices and mechanisms therefor,” filed on Dec. 22, 2009, which published as PCT Publication WO 10/073246; [0348] PCT Patent Application PCT/IL2010/000357 to Maisano et al., entitled, “Implantation of repair chords in the heart,” filed on May 4, 2010, which published as WO 10/128502; [0349] PCT Patent Application PCT/IL2010/000358 to Zipory et al., entitled, “Deployment techniques for annuloplasty ring and over-wire rotation tool,” filed on May 4, 2010, which published as WO 10/128503; [0350] US Patent Application Publication 2014/0309661 to Sheps et al.; and/or [0351] US Patent Application Publication 2015/0272734 to Sheps et al.
[0352] All of these applications are incorporated herein by reference. Techniques described herein can be practiced in combination with techniques described in one or more of these applications.
[0353] 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 and steps 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.