Source: http://www.google.es/patents/US9180007
Timestamp: 2017-11-19 16:29:27
Document Index: 202777775

Matched Legal Cases: ['art 2', 'art 2', 'art 2', 'art 2', 'art 2', 'art 2', 'Application No. 201080059948', 'Application No. 200980157331', 'application No. 201080059948']

Patente US9180007 - Apparatus and method for guide-wire based advancement of an adjustable implant - Google Patentes
Apparatus is provided, comprising (1) a guide member, (2) a tissue-adjustment mechanism having (a) an upper surface and a lower surface, (b) at least one first opening at the upper surface, (c) at least one second opening at the lower surface, and (4) a channel extending between the first and second...http://www.google.es/patents/US9180007?utm_source=gb-gplus-sharePatente US9180007 - Apparatus and method for guide-wire based advancement of an adjustable implant
Número de publicación US9180007 B2
Número de solicitud US 13/707,013
Fecha de prioridad 29 Oct 2009
También publicado como US20130096672, US20160058557
Número de publicación 13707013, 707013, US 9180007 B2, US 9180007B2, US-B2-9180007, US9180007 B2, US9180007B2
Inventores Tal Reich, Eran Miller, Tal Sheps
Citas de patentes (364), Otras citas (115), Citada por (2), Clasificaciones (15), Eventos legales (1)
US 9180007 B2
Apparatus is provided, comprising (1) a guide member, (2) a tissue-adjustment mechanism having (a) an upper surface and a lower surface, (b) at least one first opening at the upper surface, (c) at least one second opening at the lower surface, and (4) a channel extending between the first and second openings, the channel facilitating advancement of the tissue-adjustment mechanism along the guide member; and (3) at least one repair chord coupled at a first portion thereof to the tissue-adjustment mechanism and having at least a first end that is configured to be coupled to a portion of tissue of a patient, the repair chord being configured to adjust a distance between the portion of tissue and the tissue-adjustment mechanism, in response to adjustment of the repair chord by the tissue-adjustment mechanism. Other embodiments are also described.
1. Apparatus for use with tissue of a heart of a subject, the apparatus comprising:
at least one docking assembly, having:
a distal portion comprising a tissue anchor that is configured to engage a portion of the tissue,
a proximal portion, fixedly coupled to the distal portion, and comprising at least one docking station that comprises a first coupling;
at least one guide member, reversibly coupled to the at least one docking station; and
an annuloplasty ring selected from the group consisting of: a partial annuloplasty ring and a full annuloplasty ring, the selected annuloplasty ring:
comprising a second coupling,
being slidable along the guide member toward the docking station, and
configured to be locked to the docking station by the second coupling being locked to the first coupling.
2. The apparatus according to claim 1, wherein the second coupling is lockable to the first coupling by being pushed against the first coupling.
3. The apparatus according to claim 1, wherein the annuloplasty ring is configured to be locked to the docking station sutureles sly.
4. The apparatus according to claim 1, wherein the docking assembly is percutaneously deliverable to the heart of the subject, and the annuloplasty ring is percutaneously lockable to the docking station.
the at least one docking assembly comprises a plurality of docking assemblies,
the at least one guide member comprises a respective plurality of guide members, each of the guide members being reversibly coupled to a respective docking station of a respective docking assembly,
the selected annuloplasty ring comprises a respective plurality of second couplings, and is slidable along the plurality of guide members toward the plurality of docking assemblies, and
each of the second couplings is lockable to a respective first coupling of a respective docking station.
6. The apparatus according to claim 1, wherein the selected annuloplasty ring comprises an adjustable annuloplasty ring, comprising a rotatable structure that is:
bidirectionally rotatable to adjust the selected annuloplasty ring,
shaped to define a channel between an upper surface thereof and a lower surface thereof, the guide member being disposable in the channel, and
shaped to define the second coupling, and
wherein the selected annuloplasty ring is slidable along the guide member by the rotatable structure being slidable along the guide member.
the selected annuloplasty ring comprises:
a sleeve, having a longitudinal length from a first end thereof to a second end thereof, and defining lumen therebetween; and
a flexible longitudinal member, at least part of which is disposed in at least part of the lumen, and
the rotatable structure is:
coupled to a first end portion of the flexible longitudinal member, and
bidirectionally rotatable to adjust the longitudinal length of the sleeve by adjusting a degree of tension of the flexible longitudinal member.
8. The apparatus according to claim 7, further comprising a rotatable structure locking mechanism displaceable with respect to the rotatable structure, so as to release the rotatable structure during rotation of the rotatable structure, and lock in place the rotatable structure following rotation of the rotatable structure.
9. The apparatus according to claim 8, further comprising a release rod:
shaped to define a lumen therethrough, the guide member being disposable within the lumen of the release rod, and
configured to unlock the rotatable structure locking mechanism by being slid over the guide member.
10. The apparatus according to claim 1, wherein the at least one docking station is configured to be coupled to the selected annuloplasty ring such that the at least one docking station is disposed between the selected annuloplasty ring and the tissue anchor.
11. Apparatus for use with tissue of a body of a subject, the apparatus comprising:
a docking assembly, having:
a proximal portion, fixedly coupled to the distal portion, and comprising at least one docking station shaped to define a first coupling;
an adjustable implant comprising an adjustment mechanism, the adjustment mechanism being:
advanceable into the body separately from the docking assembly,
actuatable to adjust a dimension of the implant while the implant is disposed within the body,
shaped to define a second coupling,
shaped to define a channel through which the guide member is slidable, such that the adjustment mechanism is slidable over the guide member toward the docking station, and
intracorporeally lockable to the docking station by the second coupling being locked to the first coupling.
12. The apparatus according to claim 11, wherein the adjustable implant comprises an adjustable annuloplasty ring selected from the group consisting of: a partial annuloplasty ring and a full annuloplasty ring.
13. The apparatus according to claim 12, wherein the adjustment mechanism is intracorporeally lockable to the docking station such that the docking station is disposed between the adjustable implant and the tissue anchor.
14. Apparatus for use with tissue of a heart of a subject, the apparatus comprising:
at least one guide member, reversibly attached to the at least one docking station; and
an annuloplasty ring selected from the group consisting of: a partial annuloplasty ring and a full annuloplasty ring, the selected annuloplasty ring being:
slidable along the guide member toward the docking station, and
15. The apparatus according to claim 14, wherein the second coupling is lockable to the first coupling by being pushed against the first coupling.
16. The apparatus according to claim 14, wherein the annuloplasty ring is configured to be locked to the docking station sutureles sly.
17. The apparatus according to claim 14, wherein the docking assembly is percutaneously deliverable to the heart of the subject, and the annuloplasty ring is percutaneously lockable to the docking station.
the at least one guide member comprises a respective plurality of guide members, each of the guide members being reversibly attached to a respective docking station of a respective docking assembly,
the selected annuloplasty ring is shaped to define a respective plurality of second couplings, and is slidable along the plurality of guide members toward the plurality of docking assemblies, and
19. The apparatus according to claim 14, wherein the selected annuloplasty ring comprises an adjustable annuloplasty ring, comprising a rotatable structure that is:
20. The apparatus according to claim 14, wherein the at least one docking station is configured to be coupled to the selected annuloplasty ring such that the at least one docking station is disposed between the selected annuloplasty ring and the tissue anchor.
(a) International Application PCT/IL2011/000446 to Miller et al., entitled “Apparatus and method for guide-wire based advancement of a rotation assembly,” filed on Jun. 6, 2011 (which published as WO/2011/154942);
(b) U.S. patent application Ser. No. 12/795,192 to Miller et al., entitled “A method for guide-wire based advancement of a rotation assembly,” filed on Jun. 7, 2010 (which published as U.S. 2011/0301698) (now U.S. Pat. No. 8,690,939); and
(c) U.S. patent application Ser. No. 12/795,026 to Miller et al., entitled “Apparatus for guide-wire based advancement of a rotation assembly,” filed on Jun. 7, 2010 (which published as U.S. 2011/0106245) (now U.S. Pat. No. 8,940,042), which is a continuation-in-part of U.S. patent application Ser. No. 12/608,316 to Miller et al., entitled, “Tissue anchor for annuloplasty device,” filed on Oct. 29, 2009 (now U.S. Pat. No. 8,277,502).
In some applications of the present invention, apparatus is provided comprising an implant comprising one or more primary adjustable repair chords and an adjustment mechanism that is configured to adjust a tension of the one or more adjustable repair chords and that is slidable along a guide wire toward an implantation site. Additionally, the apparatus comprises a first tissue-engaging element (e.g., a tissue anchor) that comprises one or more docking stations. Further additionally, in accordance with some applications of the present invention, a method is provided for implanting such apparatus. A respective guide wire is reversibly coupled to each one of the docking stations. The adjustment mechanism is slidable along the guide wire toward one of the one or more docking stations, and is coupled to the tissue-engaging element via the docking station. Thus, the docking station is a coupling element that provides coupling between two other elements (in this case, between adjustment mechanism and the tissue-engaging element.)
The repair chord comprises a flexible, longitudinal member (e.g., sutures or wires). The repair chord is coupled at a distal portion thereof to the adjustment mechanism. In some applications, the repair chord functions as artificial chordae tendineae. In other applications, the repair chord is used to adjust a distance between two portions of the ventricular wall. For some applications, the repair chord is coupled at a proximal portion thereof to a second tissue-engaging element (e.g., a tissue anchor which penetrates or clips a portion of tissue).
For other applications, the repair chord comprises a cord that is disposed within at least a portion of an annuloplasty ring structure (e.g., a full annuloplasty ring or a partial annuloplasty ring). For such applications, the annuloplasty ring structure comprises the adjustment mechanism that is coupled to the repair cord. The annuloplasty ring structure is slidable along the guide wire toward one of the one or more docking stations, and is coupled to the tissue-engaging element via the docking station. It is to be noted that the annuloplasty ring structure may be provided independently of the adjustment mechanism and the repair chord. For such applications, the annuloplasty ring structure is slidable along the guide wire toward one of the one or more docking stations, and is coupled to the tissue-engaging element via the docking station.
For yet other applications, a prosthetic heart valve and/or a support for the prosthetic heart valve is slidable along the guide wire toward one of the one or more docking stations, and is coupled to the tissue-engaging element via the docking station.
Thus, the tissue-engaging element and the docking station are used to facilitate implantation of an implant such as cardiac valve implants, namely annuloplasty ring structures, prosthetic valves, and/or apparatus for receiving a prosthetic valve (e.g., a docking station or a support for receiving the prosthetic valve).
Typically, during a transcatheter procedure, the first tissue-engaging element is coupled to a first portion of tissue at a first implantation site in a heart of a patient. The adjustment mechanism is then slid along the guide wire and toward the first tissue-engaging element at the first implantation site. The proximal portion of the repair chord is then coupled via the second tissue-engaging element to a second portion of tissue at a second implantation site. Following the coupling of the second tissue-engaging element to the second implantation site, the adjustment mechanism is further slid distally toward the first tissue-engaging element and is then coupled to the first tissue-engaging element via the one or more docking stations on the first tissue-engaging element. Following the coupling of the adjustment mechanism to the second tissue-engaging element, a length and tension of the repair chord is then adjusted in order to adjust a distance between the first and second implantation sites. For applications in which the repair chord functions as an artificial chordea tendinea, the adjustment of the length and tension of the repair chord draws the leaflets together, and/or pulls the leaflet down toward the first implantation site to repair the valve.
In some applications of the present invention, the adjustable repair chord is implanted during an open-heart or minimally-invasive procedure. In these applications, the delivery tool comprises a handle and a multilumen shaft that is coupled at a distal end thereof to the adjustment mechanism. The delivery tool functions to advance the adjustment mechanism to the first portion of tissue, implant the adjustment mechanism at the first portion of tissue, and effect adjustment of the repair chord by effecting rotation of the spool. For applications in which the repair chord functions as an artificial chordea tendinea, prior to implantation of the adjustment mechanism, the distal portion of the delivery tool and the adjustment mechanism coupled thereto are advanced between the leaflets of the atrioventricular valve and into the ventricle toward the first portion of tissue. The incision made in the heart is then closed around the delivery tool and the heart resumes its normal function during the adjustment of the length of the artificial chordea tendinea.
In some applications of the present invention, apparatus and method described herein may be used for providing artificial chordae tendineae in a left ventricle of the heart and effecting adjustment thereof. In some applications, apparatus and method described herein may be used for providing artificial chordae tendineae in a right ventricle of the heart and effecting adjustment thereof. In some applications, apparatus and method described herein may be used for providing a system to adjust a length between two portions of the heart wall. For other applications apparatus and method described herein may be used for providing a docking station for an annuloplasty ring or for a prosthetic valve.
There is further provided, in accordance with an application of the present invention, apparatus for use with tissue of a heart of a subject, the apparatus including:
a distal portion including a tissue anchor that is configured to engage a portion of the tissue,
a proximal portion, fixedly coupled to the distal portion, and including at least one docking station that includes a first coupling;
shaped to define a second coupling, and
configured to be locked to the docking station by the second coupling being lockable to the first coupling.
In an application, the second coupling is lockable to the first coupling by being pushed against the first coupling.
In an application, the annuloplasty ring is configured to be locked to the docking station suturelessly.
In an application, the docking assembly is percutaneously deliverable to the heart of the subject, and the annuloplasty ring is percutaneously lockable to the docking station.
the at least one docking assembly includes a plurality of docking assemblies,
the at least one guide member includes a respective plurality of guide members,
each of the guide members being reversibly coupled to a respective docking station of a respective docking assembly,
the each of the second couplings is lockable to a respective first coupling of a respective docking assembly.
In an application, the selected annuloplasty ring includes an adjustable annuloplasty ring, including a rotatable structure that is:
the selected annuloplasty ring is slidable along the guide member by the rotatable structure being slidable along the guide member.
the selected annuloplasty ring includes:
a sleeve, having a longitudinal length from a first end thereof to a second end thereof, and defining lumen therebetween,
the rotatable structure, and
In an application, the apparatus further includes a rotatable structure locking mechanism displaceable with respect to the rotatable structure, so as to release the rotatable structure during rotation of the rotatable structure, and lock in place the rotatable structure following rotation of the rotatable structure.
In an application, the apparatus further includes a release rod:
a docking assembly:
having a distal portion including a tissue anchor that is configured to engage cardiac tissue of a subject,
having a proximal portion including at least one docking station that includes a first coupling;
a guide member reversibly coupled to the at least one docking station; and
an adjustable annuloplasty ring selected from the group consisting of: a partial annuloplasty ring and a full annuloplasty ring, the selected annuloplasty ring:
a rotatable structure:
coupled to a first end portion of the flexible longitudinal member,
bidirectionally rotatable to adjust the longitudinal length of the sleeve by adjusting a degree of tension of the flexible longitudinal member,
shaped to define (1) a channel between an upper surface thereof and a lower surface thereof, the guide member being disposable in the channel, and (2) a second coupling, and
(b) being slidable along the guide member toward the docking assembly, and configured to lock the selected annuloplasty ring to the docking assembly by the second coupling being lockable to the first coupling.
There is further provided, in accordance with an application of the present invention, a method for use with tissue of a heart of a subject, the method including:
advancing a docking station assembly to the tissue, the docking station assembly including (1) a distal portion including a tissue anchor that is configured to engage a portion of the tissue, and (2) a proximal portion, fixedly coupled to the distal portion, and including at least one docking station that includes a first coupling;
advancing, along a guide member that is reversibly coupled to the docking station,
an annuloplasty ring selected from the group consisting of: a partial annuloplasty ring and a full annuloplasty ring, the selected annuloplasty ring being shaped to define a second coupling; and
locking the selected annuloplasty ring to the docking station by locking the second coupling to the first coupling.
There is further provided, in accordance with an application of the present invention, apparatus for use with at least one implant, including:
at least one docking station coupled to the proximal portion of the tissue-engaging element, the at least one docking station:
being configured to receive and be coupled to the at least one implant, and
including a locking mechanism configured to lock the implant to the docking station; and
at least one guide member reversibly coupled to the at least one docking station,
the at least one guide member being configured for facilitating slidable advancement of the at least one implant toward the docking station.
In an application, the at least one docking station includes two or more docking stations, and the at least one guide member includes two or more guide members, each guide member being reversibly coupled to a respective docking station.
In an application, the implant includes at least one implant selected from the group consisting of: a prosthetic cardiac valve and a support for receiving a prosthetic cardiac valve, and the at least one docking station is configured to receive and be coupled to the selected implant.
In an application, the implant includes a tissue-adjustment device selected from the group consisting of: a partial annuloplasty ring and a full annuloplasty ring, and the at least one docking station is configured to receive and be coupled to the selected tissue-adjustment device.
In an application, the implant has:
a channel extending between the first and second openings, the channel facilitating advancement of the implant along the guide member.
In an application, the implant includes a first coupling, and the locking mechanism includes a second coupling configured to be coupled to the first coupling.
In an application, the second coupling includes at least one depressed portion, and the first coupling includes at least one moveable baffle which is configured to engage the at least one depressed portion of the second coupling.
In an application, the apparatus further includes at least one flexible longitudinal member coupled at a first portion thereof to the implant, a second portion of the flexible longitudinal member is configured to be coupled to a second portion of tissue of the patient, and the implant is configured to adjust a length of the longitudinal member between the first and second portions of tissue.
the first portion of tissue includes a first portion of cardiac tissue at a first intraventricular site,
the second portion of tissue includes at least one leaflet of an atrioventricular valve of the patient, and
the flexible longitudinal member includes at least one artificial chordea tendinea.
the implant includes a rotatable structure,
the at least one flexible longitudinal member is coupled at the first portion to the rotatable structure, and
the rotatable structure is bidirectionally rotatable to adjust the degree of tension of the at least one flexible longitudinal member.
In an application, the rotatable structure is configured such that:
rotation of the rotatable structure in a first rotational direction applies tension to the flexible longitudinal member, and
rotation of the rotatable structure in a second rotational direction that is opposite the first rotational direction slackens the flexible longitudinal member.
In an application, the apparatus further includes a rotatable structure locking mechanism displaceable with respect to the rotatable structure, so as to:
release the rotatable structure during rotation of the rotatable structure, and
lock in place the rotatable structure following rotation of the rotatable structure.
In an application, the rotatable structure includes a spool, and the at least one flexible longitudinal member is configured to be wound around the spool during the rotation of the spool in a first rotational direction.
the implant includes a rotatable structure, coupled to a flexible longitudinal member,
the rotatable structure is bidirectionally rotatable to adjust a degree of tension of the flexible longitudinal member, and
the at least one docking station is configured to receive and be coupled to the rotatable structure.
including a locking mechanism configured to lock the implant to the tissue-engaging element; and
at least one guide member reversibly coupled to the at least one docking station, the at least one guide member being configured for facilitating slidable advancement of the at least one implant toward the tissue-engaging element.
In an application, the guide member is looped around a portion of the docking station.
In an application, the implant includes a prosthetic cardiac valve.
In an application, the implant includes a support for receiving a prosthetic cardiac valve.
In an application, the implant includes a tissue-adjustment device.
In an application, the tissue-adjustment device includes an annuloplasty ring structure selected from the group consisting of: a partial annuloplasty ring and a full annuloplasty ring.
In an application, the apparatus further includes the implant, and the implant has:
a channel extending between the first and second opening, the channel facilitating advancement of the implant along the guide member.
In an application, during rotation of the rotatable structure in a first rotational direction, successive portions of the flexible longitudinal member advance in a first advancement direction with respect to the rotatable structure and contact the rotatable structure, to pull the second portion of the flexible member toward the rotatable structure, and to draw the first and second portions of tissue toward each other.
In an application, the first portion of the at least one flexible longitudinal member is looped through a portion of the spool.
In an application, the first portion of the at least one flexible longitudinal member is wound around a portion of the spool, and the first portion of the at least one flexible longitudinal member is configured to be unwound from around the portion of the spool following the coupling of the second portion of the flexible longitudinal member to the second portion of tissue of the patient.
a tissue-engaging element having a distal portion configured to engage at least a first portion of tissue of a patient, and having a proximal portion;
at least one docking station coupled to the proximal portion of the tissue-engaging element, the at least one docking station being configured to be coupled to the at least one tissue-adjustment device;
a implant including:
a rotatable structure; and
at least one flexible longitudinal member having a first portion thereof that is in contact with the rotatable structure, and a second portion thereof that is configured to be coupled to a second portion of tissue of the patient,
and during rotation of the rotatable structure in a first rotational direction, successive portions of the flexible longitudinal member advance in a first advancement direction with respect to the rotatable structure and contact the rotatable structure, and, pull the second portion of the flexible longitudinal member toward the implant, and responsively, to draw the first and second portions of tissue toward each other; and
the at least one guide member being configured for facilitating slidable advancement of the at least one implant toward the tissue-engaging element.
In an application, the implant includes a first coupling, and the docking station includes a second coupling configured to be coupled to the first coupling.
In an application, the second coupling includes a locking mechanism configured to lock the implant to the tissue-engaging element.
In an application, the rotatable structure is rotatable in a first rotational direction to apply tension to the flexible longitudinal member, and in a second rotational direction that is opposite the first rotational direction to slacken the flexible longitudinal member.
In an application, during rotation of the rotatable structure in a first rotational direction thereof, successive portions of the flexible longitudinal member advance in a first advancement direction with respect to the rotatable structure and contact the rotatable structure, responsively, to pull the second portion of the flexible longitudinal member toward the rotatable structure.
In an application, the apparatus further includes a rotatable structure locking mechanism, displaceable with respect to the rotatable structure so as to:
In an application, the rotatable structure includes a spool, and the at least one flexible longitudinal member is configured to be wound around the spool during the rotation of the spool in the first rotational direction.
In an application, the first portion of the flexible longitudinal member is looped through a portion of the spool.
In an application, the first portion of the flexible longitudinal member is wound around a portion of the spool, and the first portion of the flexible longitudinal member is configured to be unwound from around the portion of the spool following the coupling of the second portion of the flexible longitudinal member to the second portion of tissue of the patient.
FIG. 18 is a schematic illustration of wall-to-wall adjustment using the docking station, adjustment mechanism, and repair chord, in accordance with some other applications of the present invention;
FIGS. 19-20 are schematic illustrations of adjustment of a valve of a patient from a middle portion of the valve, in accordance with some applications of the present invention;
FIG. 21 is a schematic illustration of the tissue-engaging element and the docking station of FIGS. 1 and 2 being used to facilitate implantation of an implant at a cardiac valve, in accordance with some applications of the present invention; and
FIG. 22 is a schematic illustration of the tissue-engaging element and the docking station of FIGS. 1 and 2 being used to facilitate implantation of an annuloplasty ring at a cardiac valve, in accordance with some applications of the invention.
Reference is now made to FIGS. 1-2, which are schematic illustrations of a system 20 comprising a docking assembly 150 for implantation at a first implantation site 5 of a patient, in accordance with some applications of the present invention. As shown in FIG. 2, docking assembly 150 comprises a tissue-engaging element having (1) a distal portion comprising a tissue anchor 50 (e.g., a helical tissue anchor as shown by way of illustration and not limitation), and (2) a proximal portion comprising a docking platform 54, and at least one docking station 56. Thus, docking assembly 150 comprises (a) the distal portion which engages the tissue of the patient (i.e., the tissue-engaging element), and (b) the proximal portion which is coupled to docking station 56. It is to be noted that the distal portion and the proximal portion are fixedly coupled to each other (e.g., immovable with respect to each other), and thereby docking station 56 and tissue anchor 50 are fixedly coupled to each other (e.g., immovable with respect to each other). Docking assembly 150 is thereby an integrated unit that comprises the docking station and tissue anchor. At least one guide member, (e.g., a guide wire 40, shown in FIG. 2) is reversibly coupled to docking assembly 150 (e.g., by being looped around, or otherwise coupled to, a portion of assembly 150) so as to define first and second portions 40 a and 40 a′ that extend away from assembly 150.
Docking assembly 150 is implanted in implantation site 5 by rotating tool 30 in order to rotate anchor 50 and corkscrew anchor 50 into tissue of site 5. Site 5 typically comprises a portion of tissue at an intraventricular site in heart 2 of the patient. As shown, site 5 includes a papillary muscle 4, by way of illustration and not limitation. It is to be noted that site 5 includes any portion of cardiac tissue, e.g., a portion of a free wall of the ventricle, a portion of the septum facing the ventricle, a portion of tissue at a base of the papillary muscle, or a portion of the wall at the apex of the ventricle. (For the purposes of the claims, “a portion of tissue of a ventricle” includes any portion of cardiac tissue, e.g., a portion of a free wall of the ventricle, a portion of the septum facing the ventricle, a portion of tissue at a base of the papillary muscle, or a portion of the wall at the apex of the ventricle.)
As shown in FIG. 5, portions 74 a and 74 b extend from leaflet-engaging element 72 toward adjustment mechanism 43. Portions 74 a and 74 b define portions of a single chord 74 that is looped through a portion of mechanism 43. Alternatively, portions 74 a and 74 b represent two distinct chords which are coupled at their distal ends to adjustment mechanism 43 and at their proximal ends to leaflet-engaging element 72.
Housing 49 is shaped so as to provide openings 41 a and 41 b for passage therethrough of portions 74 a and 74 b, respectively, of chord 74 into housing 49. For some applications of the present invention, portions 74 a and 74 b define portions of a single chord 74 that is looped through spool 46. For other applications, portions 74 a and 74 b define discrete chords which are each coupled at respective distal ends thereof to spool 46.
FIG. 8 shows system 20 following the removal of the tool used to rotate spool 46 of spool assembly 36, in accordance with some applications of the present invention. As shown, chord 74 is pulled tight such that its length and tension are adjusted, and leaflet 14 is pulled and adjusted commensurate with the adjustment of chord 74. Guide wire 40 remains coupled to spool assembly 36 and to docking assembly 150, as shown, such that portions 40 a and 40 a′ extend from spool assembly 36. Guide wire 40 facilitates the reintroduction of the tool used to rotate spool 46, or of any other tool.
FIGS. 11-15 are schematic illustrations of a system 320 comprising a multiple-docking-station assembly 350 comprising a plurality of docking stations 56, in accordance with some applications of the present invention. Multiple-docking-station assembly 350 comprises a tissue anchor 50 and a docking platform 322 which supports two or more docking stations 56. Platform 322, as shown, supports three docking stations 56 a, 56 b, and 56 c, by way of illustration and not limitation. It is to be noted that platform 322 may support any number of docking stations 56. As shown, each docking station 56 a, 56 b, and 56 c is reversibly coupled to a respective guide wire 40 a, 40 b, and 40 c, in a manner as described hereinabove. Each docking station 56 a, 56 b, and 56 c facilitates coupling thereto of a respective spool assembly 36 a, 36 b, and 36 c, or any other tool or device which may be coupled to docking stations 56 a, 56 b, and 56 c.
As shown in FIGS. 11-13, first and second spool assemblies 36 a and 36 b are coupled via respective guide wires 40 a and 40 b to respective docking stations 56 a and 56 b. Each spool assembly 36 a and 36 b has a respective chord 74 aa and 74 bb extending therefrom (FIG. 13). For example (as shown in FIG. 12), the chord extending from spool assembly 36 a has portions 74 aa and 74 aa′ extending from spool assembly 36 a. Each chord 74 is coupled to a respective leaflet-engaging element 72. That is, chord 74 aa is coupled to leaflet-engaging element 72 a, and chord 74 bb is coupled to leaflet-engaging element 72 b (FIG. 13).
Each leaflet-engaging element 72 a and 72 b is coupled to leaflets 12 and 14, respectively, and then each spool assembly 36 a and 36 b is coupled to respective docking stations 56 a and 56 b, in a manner as described hereinabove. Chords 74 aa and 74 bb are then adjusted, as described hereinabove. Each chord 74 aa and 74 bb may be adjusted sequentially or simultaneously.
FIG. 13 shows chords 74 aa and 74 bb following their adjustment. The relative dispositions of leaflets 12 and 14 are adjusted in conjunction with the adjusting of chords 74 aa and 74 bb. Typically, leaflets 12 and 14 are drawn together to repair the heart valve.
As shown in FIG. 15, a third spool assembly 36 c may be coupled to docking station 56 c. Chord 74 c coupled thereto may be coupled to a third implantation site in heart 2 and subsequently adjusted. FIG. 15 shows third spool assembly 36 c coupled to docking station 56 c without the presence of the other spool assemblies 36 a and 36 b, by way of illustration and not limitation.
FIG. 17 shows a system 610 for adjusting both malpositioning of a heart wall of heart 2, and a relative disposition of leaflet 12, in accordance with some applications of the present invention. Multiple-docking-station assembly 350 is implanted at implantation site 5, i.e., a portion of tissue of a heart wall of heart 2 in a vicinity of the apex of heart 2. It is to be noted that implantation site 5 may include any portion of tissue of heart 2, e.g., a portion of tissue at the base of papillary muscle 4, a portion of tissue of papillary muscle 4, or a portion of the free wall of the ventricle. As described hereinabove, first spool assembly 36 a is coupled to docking station 56 a and adjusts a length of chord 74 aa in order to adjust a distance between implantation sites 5 and 7. Second spool assembly 36 b is coupled to docking station 56 b and adjusts a length of chord 74 bb in order to adjust a distance between implantation site 5 a third implantation site 9 (e.g., leaflet 12, as shown). As described hereinabove, chords 74 aa and 74 bb may be adjusted simultaneously or sequentially. Following the adjusting, implantation sites 7 and 9 are drawn toward multiple-docking-station assembly 350 at implantation site 5. Consequently, the dimensions of the heart wall are restored to physiological dimensions, and leaflets 12 and 14 are drawn toward one another. It is to be noted that although leaflet-engaging element 72 is shown as engaging only leaflet 12, the scope of the present invention includes the engaging of both leaflets 12 and 14 by leaflet-engaging element 72.
It is to be further noted that the scope of the present invention includes the coupling of a third spool assembly to docking station 56 c coupled to chord 74 c. For such applications, the free end of chord 74 c may be coupled to a different portion of cardiac tissue, e.g., leaflet 14.
Tensioning device 802 comprises a flexible material, e.g., ePTFE or nitinol, and is shaped to define a coiled portion 806 that has a length of between 20 mm and 50 mm and a diameter of between 0.5 mm and 3.0 mm. Tensioning device 802 comprises respective wire/suture portions 804 on either side of coiled portion 806. For such an application, the suture portion 804 that is between spool assembly 36 and coiled portion 806 comprises portions 74 a and 74 b of chord 74.
Reference is now made to FIG. 19, which is a schematic illustration of a system 960 for drawing together leaflets 12 and 14 of mitral valve 8 of the patient, in accordance with some applications of the present invention. Spool assembly 36 is implanted via docking assembly 150 in first implantation site 5 at papillary muscle 4 of the left ventricle by way of illustration and not limitation. For example, spool assembly 36 may be implanted in a portion of the heart wall of the ventricle, e.g., the base of the papillary muscle. First and second portions 74 a and 74 b of chord 74 are coupled (e.g., sutured, anchored, clipped, or locked in place with a crimping bead 918, as shown) to leaflet 12 at an implantation site 902. It is to be noted that portions 74 a and 74 b may be coupled to leaflets 12 and 14, respectively, using leaflet-engaging elements 72 as described hereinabove.
System 960 further comprises at least one bead 940 that is threaded over portions 74 a and 74 b of chord 74. The surgeon adjusts the position of the bead along the portions 74 a and 74 b in order to set the degree to which portions 74 a and 74 b are free to move with respect to one another. In general, as bead 940 is positioned closer to valve 8, portions 74 a and 74 b are more constrained in their motion with respect to one another, and leaflets 12 and 14 are drawn closer together. For some applications of the present invention, bead 940 comprises a fixation mechanism (e.g., a crimping mechanism), which is configured to fix the bead to portions 74 a and 74 b of chord 74 once bead 940 has been positioned at a desire location along portions 74 a and 74 b.
FIG. 20 shows a system 980 that is similar to system 960 as described with reference to FIG. 19, with the exception that bead 940 is pulled by the operating physician to the ventricular surface of a middle portion of valve 8, in accordance with some applications of the present invention. Such pulling of bead 940 to the ventricular surface creates a bridge between leaflets 12 and 14, e.g., as an Alfieri stitch, or edge-to-edge repair. Portions 74 a and 74 b are then adjusted in order to pull together the middle portion of mitral valve 8, as shown in Section A-A. The firm coupling of leaflets 12 and 14 prevents prolapsing of leaflets 12 and 14, facilitates coaptation of leaflets 12 and 14, and creates orifices 962 and 964 (section A-A) in mitral valve 8 so as to facilitate blood flow from the atrium to the ventricle. Additionally, the adjusting of portions 74 a and 74 b of chord 74 draws downward leaflets 12 and 14 and adjusts chord 74 such that it functions as an artificial chordea tendinea.
Reference is now made to FIG. 21, which is a schematic illustration of a system 1000 comprising docking assembly 150 for implantation at an implantation site 5 a that includes an annulus 1100 of a cardiac valve of the patient, in accordance with some applications of the present invention. It is to be noted that the mitral valve is shown by way of illustration and not limitation, and that system 1000 can be used on any other cardiac valve of the patient, e.g., the tricuspid valve, the pulmonary valve, and the aortic valve. System 1000 comprises docking assembly 150 and the guide member coupled thereto (e.g., guide wire 40), as described hereinabove with reference to FIGS. 1-2.
Reference is made to FIG. 22, which is a schematic illustration of system 1000 being used to facilitate implantation of implant 42, comprising an annuloplasty ring 1120, at annulus 1100 of a cardiac valve, in accordance with some applications of the invention. It is to be noted that the mitral valve is shown by way of illustration and not limitation, and that system 1000 can be used on any other cardiac valve of the patient, e.g., the tricuspid valve, the pulmonary valve, and the aortic valve. It is to be noted that annuloplasty ring 1120 is shown as a partial annuloplasty ring by way of illustration and not limitation, and that annuloplasty ring 1120 may comprise a full annuloplasty ring. Docking assembly 150 is advanced to the annulus, and tissue anchor 50 is anchored to tissue in the vicinity of the annulus (e.g., to tissue of the annulus). For applications in which tissue anchor 50 comprises a helical tissue anchor, the anchor is typically coupled to the tissue by rotating the entire docking assembly 150 (e.g., using a delivery tool, such as delivery tool 30, described hereinabove with reference to FIGS. 1-2, mutatis mutandis). As described hereinabove (e.g., with reference to FIG. 2), a guide member (e.g., guide wire 40) is left behind, coupled to docking assembly 150 (e.g., to docking station 56 thereof).
Subsequently, and as shown in FIG. 22, annuloplasty ring 1120 is advanced along guide wire 40 toward annulus 1100 and docking assembly 150. Typically, annuloplasty ring 1120 is shaped to define a channel therethrough (e.g., between an upper surface and a lower surface of the annuloplasty ring), within which guide wire 40 is configured to be disposed, and the annuloplasty ring is slid over the guide wire. For some applications, and as shown in FIG. 22, annuloplasty ring 1120 comprises an adjustable annuloplasty ring that comprises an adjustment mechanism 1143, configured to adjust the annuloplasty ring (e.g., as described hereinbelow). For some such applications, adjustment mechanism 1143 is shaped to define the channel within which guide wire 40 is configured to be disposed.
Typically, adjustment mechanism 1143 comprises adjustment mechanism 43 and/or spool assembly 36, described hereinabove. Further typically, annuloplasty ring 1120 comprises a sleeve 1126 that defines a lumen therethrough, and a flexible longitudinal member 1130, disposed at least in part within the lumen of the sleeve, and adjustment mechanism 1143 is configured to adjust the length of the sleeve (e.g., the diameter of the annuloplasty ring) by adjusting the length of the flexible longitudinal member. For some applications, flexible longitudinal member 1130 is coupled to and adjusted by adjustment mechanism 1143, in a similar manner to that in which chord 74 is coupled to and adjusted by adjustment mechanism 43, described hereinabove.
Once annuloplasty ring 1120 reaches docking assembly 150, the annuloplasty ring is locked to the docking assembly as described hereinabove (e.g., with reference to FIG. 6), mutatis mutandis. That is, a coupling defined by the annuloplasty ring is locked to a coupling defined by the docking assembly, typically by the couplings being pushed toward and/or into each other.
For some applications, additional anchors are subsequently used to couple other portions of annuloplasty ring 1120 to other portions of tissue in the vicinity of annulus 1100. For example, and as shown in FIG. 22, annuloplasty ring 1120 may comprise a partial annuloplasty ring that comprises sleeve 1126, and successive portions of sleeve 1126 may be placed on annulus 1100, and anchored to the annulus using a plurality of successive anchors 1140, deployed using a deployment manipulator 1142, from within the lumen of the sleeve, through the wall of the sleeve, and into the annulus. For some such applications, docking assembly 150 is used to guide and anchor a first portion of the annuloplasty ring to a first anchoring site of the annulus, and successive anchors 1140 are subsequently used to anchor other portions of the annuloplasty ring.
For some applications, a plurality of docking assemblies 150 and a plurality of guide wires 40 are used to advance and lock a plurality of portions of annuloplasty ring 1120 to the tissue. For some such applications, annuloplasty ring comprises a plurality of adjustment mechanisms 1143 disposed around the length of sleeve 1126 (e.g., to adjust the length of different portions of the sleeve), and each of the adjustment mechanisms is advanced over a respective guide wire 40 and locked to a respective docking station of a respective docking assembly.
It is to be noted that the locking of annuloplasty ring 1120 to docking assembly 150 is performed suturelessly.
PCT Patent Application PCT/IL07/001503 to Gross et al., entitled, “Segmented ring placement,” filed on Dec. 5, 2007, which published as WO 08/068756;
U.S. patent application Ser. No. 12/341,960 to Cabiri, entitled, “Adjustable partial annuloplasty ring and mechanism therefor,” filed on Dec. 22, 2008, which published as 2010/0161047 (now U.S. Pat. No. 8,241,351);
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 published as 2010/0161041 (now U.S. Pat. No. 8,147,542);
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 published as 2010/0286767 (now U.S. Pat. No. 8,715,342);
PCT Patent Application PCT/IL2009/000593 to Gross et al., entitled, “Annuloplasty devices and methods of delivery therefor,” filed on Jun. 15, 2009, which published as WO 10/004546;
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 published as 2010/0161042 (now U.S. Pat. No. 8,808,368);
U.S. patent application Ser. No. 12/608,316 to Miller et al., entitled, “Tissue anchor for annuloplasty ring,” filed on Oct. 29, 2009, which published as 2011/0106247 (now U.S. Pat. No. 8,277,502);
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 WO 10/073246;
U.S. patent application Ser. No. 12/689,635 to Zipory et al., entitled, “Over-wire rotation tool,” filed on Jan. 19, 2010, which published as 2010/0280604 (now U.S. Pat. No. 8,545,553);
U.S. patent application Ser. No. 12/689,693 to Hammer et al., entitled, “Application Deployment techniques for annuloplasty ring,” filed on Jan. 19, 2010, which published as 2010/0280605 (now U.S. Pat. No. 8,911,494);
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Clasificación internacional A61B17/04, A61F2/24, A61B17/00
Clasificación cooperativa A61F2/2466, A61F2/2487, A61B2017/00783, A61B17/0401, A61B2017/0448, A61B2017/0496, A61B2017/00243, A61B2017/0464, A61F2250/0007, A61B2017/0441, A61F2/2445, A61F2/2457
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