TISSUE ANCHOR AND ANCHORING SYSTEM
An annuloplasty implant comprising an elongate member configured to be anchored to tissue of a heart, and to move between an elongate configuration and a shortened configuration and a tensioning member. The tensioning member can define a first segment and a second segment such that the first segment extends between a first tensioning-member end and a turn of the tensioning member, and the second segment extends between the turn and the second tensioning-member end. The tensioning member extends along the elongate member such that the elongate member can slide relative to the tensioning member and such that applying tension to the tensioning member causes the elongate member to move from the elongate configuration to the shortened configuration, which can cause the implant to reshape an annulus of a heart valve.
This application is a continuation of U.S. patent application Ser. No. 15/680,742, filed Aug. 18, 2017, which is a continuation of U.S. patent application Ser. No. 14/581,264, filed Dec. 23, 2014, now U.S. Pat. No. 9,814,454, issued Nov. 14, 2017, which is a continuation of U.S. patent application Ser. No. 12/273,670, filed Nov. 19, 2008, now U.S. Pat. No. 8,951,286, issued Feb. 10, 2015, which is a divisional of U.S. patent application Ser. No. 11/174,951, filed Jul. 5, 2005, now U.S. Pat. No. 8,951,285, issued Feb. 10, 2015, the contents of each of which are hereby incorporated by reference in their entireties for all purposes.
TECHNICAL FIELDThe present invention generally relates to tissue anchors and, more particularly, anchors and methods of using such anchors to secure an element or otherwise provide an anchor point to biological tissue and/or to secure at least two tissue portions together.
BACKGROUNDMany different surgical procedures require that an anchor be used to either establish a strong point of connection for other securing elements or devices relative to a tissue location in a patient, and/or to secure two or more tissue layers (i.e., portions together. In this regard, the term “anchor”, as used herein, is not to be limited to any particular type of tissue fastening or securement application but, rather, encompasses any hard and/or soft tissue-to-tissue securement, tissue-to-device securement, or any other tissue securement application.
One particular area that has received attention in recent years is that of catheter-based surgical procedures. Various tissue anchors have been developed for purposes of deployment and securement with catheter-based technology. However, there are still limitations in current technology. For example, insertion size versus deployment size must be strictly controlled due to the need for catheter diameters to be maintained relatively small. Many catheter-based tissue anchor systems have very specialized uses and are not versatile for use in many different tissue fastening or securement operations.
There is generally a need for a simpler, more versatile tissue anchor which may be deployed and securely fastened to tissue in a catheter-based operation or a non-catheter-based operation.
SUMMARYIn one aspect, the invention provides a tissue anchor comprising a generally flexible anchor member capable of being inserted through tissue and moving between an elongate configuration and a shortened configuration suitable for anchoring against at least one side of the tissue. The anchor member includes a proximal end portion, a distal end portion, and a compressible intermediate portion between the proximal end portion and the distal end portion. A tensioning member is operatively connected to the anchor member such that the anchor member can slide relative to the tensioning member. The tensioning member may be pulled to cause the anchor member to move relative to the tensioning member from the elongate configuration to the shortened configuration. In the shortened configuration, the compressible intermediate portion of the anchor member can compress or shorten and thereby adjust to the thickness of the tissue between the proximal and distal end portions.
In another aspect of the invention, a tissue anchor is provided comprising a flat, generally flexible anchor member capable of movement between an elongate configuration suitable for deployment and a shortened configuration suitable for anchoring against tissue. A tensioning member is operatively connected to the anchor member such that the anchor member can slide relative to the tensioning member. The tensioning member is capable of being pulled to cause the anchor member to move relative to the tensioning member from the elongate configuration to the shortened configuration.
In a further aspect of the invention, a tissue anchor is provided comprising a flat anchor member formed from a strip of fabric material and capable of movement between an elongate configuration suitable for deployment and a shortened configuration suitable for anchoring against tissue. A tensioning member is operatively connected to the anchor member such that the anchor member can slide relative to the tensioning member. The tensioning member is capable of being pulled to cause the anchor member to move relative to the tensioning member from the elongate configuration to the shortened configuration. A lock member is provided for securing the anchor member in the shortened configuration.
In a further aspect of the invention, a tissue anchor is provided comprising a flat, generally flexible anchor member capable of being inserted through tissue and moving between an elongate configuration suitable for deployment through a catheter and a shortened configuration suitable for anchoring against the tissue. A tensioning member is operatively connected to the anchor member such that the anchor member may slide relative to the tensioning member. The tensioning member is capable of being pulled to cause the anchor member to move relative to the tensioning member from the elongate configuration to the shortened configuration against the tissue.
In another aspect of the invention, a tissue anchor is provided comprising a flat elongate strip formed from a generally flexible material and having proximal and distal end portions. A tensioning member having first and second ends is operatively connected to the elongate strip such that pulling on the first end of the tensioning member causes the proximal and distal end portions of the elongate strip to move toward each other to a shortened configuration suitable for anchoring against the tissue.
In certain aspects, the anchor member is advantageously formed as a flat, generally flexible strip of material, while in other aspects it need not be a flat strip but may have other shapes, such as tubular, that may or may not be capable of assuming a flat shape. Various optional features may be incorporated into any or all of the various embodiments of the tissue anchor. For example, the tissue anchor may be formed from a material selected from at least one of: natural fibers, synthetic fibers, polymers, and metals. Such materials may be absorbable or nonabsorbable, and may be radiopaque or at least partially radiopaque. The tensioning member may further comprise a suture, or any other suitable flexible, semi-rigid or rigid tensioning member. The tensioning member may include a stop member engaged with the anchor member, such as a knot in the tensioning member, or a separate stop member (e.g., a crimp) engageable with the anchor member. The tensioning member may, for example, extend through the anchor member at multiple locations between the proximal end portion and the distal end portion. Such coupling of the tensioning member and the anchor member may be configured in many different manners depending, for example, on the desired configuration of the anchor member upon pulling the tensioning member and moving the anchor member into the shortened configuration. In one embodiment, at least one fold is formed upon pulling the tensioning member. Multiple folds may be formed in a generally zig-zag or accordion fashion. A lock member may be provided and engageable with the tensioning member to retain the anchor member in the shortened configuration. The tissue anchor may include at least one radiopaque marker on one or both of the anchor member and the tensioning member. For example, a first radiopaque marker may be located near the proximal end portion when the anchor member is in the shortened configuration and a second radiopaque marker may be located near the distal end portion when the anchor member is in the shortened configuration. The distal end portion of the anchor member may include a relatively more rigid tip as compared to the anchor member and having a reduced width as compared to an adjacent portion of the anchor member. The anchor member itself may be designed in any of numerous manners, including designs that have a uniform width along the length thereof, and designs that have a varying width along the length. Other features may be incorporated such as edge portions that are slightly more rigid than a central area of the anchor member. Entire sections of the anchor member may be relatively rigid as compared to fold line portions thereof while still resulting in a generally flexible anchor member. As necessary, hinge portions, such as living hinges, may be designed into the anchor member to allow for folding or other shortening action of the anchor member. While a tensioning member is specifically disclosed herein for activation purposes (that is, activating the anchor member from the elongate configuration to the shortened configuration), the invention in various combinations may utilize other types of activation, such as compressive activation.
Each of the embodiments of the tissue anchor may be part of a catheter-based anchoring system having a delivery catheter and a suitable deploying device associated with the delivery catheter and operable to extend the anchor member from the delivery catheter. The deploying device may further comprise a deploying catheter at least partially containing the anchor member and at least partially contained within the delivery catheter.
The invention further provides for various methods of anchoring tissue as generally described herein. For example, in one aspect a method of anchoring tissue is provided comprising inserting a generally flexible elongate anchor member through the tissue, and pulling a first end of a tensioning member coupled for sliding movement relative to the first anchor member to draw the proximal and distal end portions toward each other and to compress the intermediate portion into the shortened configuration with at least one of the proximal and distal end portions engaged against the tissue.
In another aspect of the invention, a method of tissue anchoring is provided comprising inserting the generally flexible flat elongate strip having proximal and distal end portions through the tissue, and pulling a first end of a tensioning member operatively connected to the strip to draw the proximal and distal end portions of the strip toward each other into the shortened configuration engaged against the tissue.
In another aspect, a method of tissue anchoring is provided comprising inserting the generally flexible flat elongate strip having proximal and distal end portions through the tissue, and pulling a first end of a tensioning member operatively connected to the strip to configure at least a portion of the strip into a shortened configuration engaged against the tissue.
In each of the embodiments engagement of the anchor member against the tissue may be engagement against opposite sides of at least one tissue layer, or engagement against only one side of at least one tissue layer.
Additional features and advantages of the invention will become readily apparent to those of ordinary skill in the art upon review of the following detailed description of the illustrative embodiments taken in conjunction with the accompanying illustrative figures.
Referring first to
A woven or nonwoven material may contain additional materials, such as threads, beads or other elements that cause at least portions of the strip 14 to be radiopaque. Currently, a surgical grade fabric constructed from polyester, such as Dacron®, is contemplated for use in constructing the strip 14. One of many possible alternative materials for use in constructing strip 14 is polytetrafluoroethylene (PTFE). Tissue anchor 10 may be partly or wholly formed from materials that are absorbed into the patient's tissue over time, depending on the intended use. The edges and/or other portions of the strip 14 may be suitably modified to prevent fraying, such as by being coated with a material that locks the fibers in place, or otherwise modified in a manner that locks the fibers at least at the edges of the strip 14 in place.
The suture 12 may extend from a proximal end portion 14a of the fabric strip 14 to a distal end portion 14b and then loop back through spaced apart points of the fabric strip 14 to the proximal end portion 14a where a knot 16 or other stop member is located for reasons to be described below. As will become apparent, the suture 12 extends through spaced apart locations along the elongate strip 14 such that tensioning of the suture 12 or other tensioning member will cause the elongate strip 14 to form folded portions 14c when the tensioning member 12 is placed under tension or pulled. Thus, the elongate strip 14 is activated in this manner between essentially an elongate deployment orientation or configuration, such as shown in
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In the illustrative example shown in
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While the present invention has been illustrated by a description of various illustrative embodiments and while these embodiments have been described in some detail, it is not the intention of the Applicant to restrict or in any way limit the scope of the appended claims to such detail. Additional advantages and modifications will readily appear to those skilled in the art. The various features of the invention may be used alone or in numerous combinations depending on the needs and preferences of the user.
Claims
1. An annuloplasty implant comprising:
- an elongate member configured to be anchored to tissue of a heart, and to move between an elongate configuration and a shortened configuration, the elongate member having a first end portion, a second end portion, and a compressible intermediate portion between the first end portion and the second end portion; and
- a tensioning member: having a first tensioning-member end and a second tensioning-member end, defining a first segment and a second segment such that (i) the first segment extends between the first tensioning-member end and a turn of the tensioning member, (ii) the second segment extends between the turn and the second tensioning-member end, and extending along the elongate member between the first end portion and the second end portion, such that the elongate member can slide relative to the tensioning member, and such that applying tension to the tensioning member causes the elongate member to move from the elongate configuration to the shortened configuration by the tensioning member pulling both the first end portion and the second end portion toward the intermediate portion and compressing the intermediate portion, which can cause the implant to reshape an annulus of a heart valve.
2. The implant according to claim 1, wherein the elongate member is formed from a material selected from at least one of: natural fibers, synthetic fibers, polymers, and metals.
3. The implant according to claim 1, wherein the tensioning member further comprises a suture.
4. The implant according to claim 1, wherein the tensioning member includes a stop member engageable with the elongate member.
5. The implant according to claim 4, wherein the stop member further comprises a knot in the tensioning member.
6. The implant according to claim 1, wherein the tensioning member extends through the elongate member at multiple locations between the first end portion and the second end portion.
7. The implant according to claim 1, wherein the elongate member and the tensioning member are configured such that the elongate member forms at least one fold upon pulling the first tensioning-member end.
8. The implant according to claim 1, further comprising a lock member engageable with the tensioning member to retain the elongate member in the shortened configuration.
9. The implant according to claim 1, further comprising at least one radiopaque marker on at least one of the elongate member and the tensioning member.
10. The implant according to claim 1, further comprising a first radiopaque marker located proximate the first end portion of the elongate member is in the shortened configuration and a second radiopaque marker located proximate the second end portion when the elongate member is in the shortened configuration.
11. The implant according to claim 1, wherein the implant comprises a tip at the second end portion, the tip being narrower and more rigid than the elongate member.
12. The implant according to claim 11, wherein the tip acts as a compressive force applying member against the second end portion of the elongate member when the elongate member is in the shortened configuration.
13. The implant according to claim 1, wherein the elongate member varies in width along its length when in the elongate configuration.
14. The implant according to claim 1, wherein the elongate member includes an edge portion that is more rigid than a central area of the elongate member.
15. The implant according to claim 1, wherein at least the first tensioning-member end is disposed at the first end portion of the elongate member.
16. A system including the implant according to claim 1 and a catheter device, wherein the implant is configured to be transluminally delivered to the heart valve through the catheter device, with the second end portion distal to the first end portion, such that deployment of the implant from the catheter device exposes the second end portion prior to the first end portion.
17. The implant according to claim 1, further comprising a catheter device configured to facilitate securing of the second end portion to the tissue, and to facilitate securing of the first end portion to the tissue subsequently to the securing of the second end portion to the tissue.
18. A system, comprising:
- an annuloplasty implant that comprises: an elongate member configured to be anchored to the tissue, and to move between an elongate configuration and a shortened configuration, the elongate member having a first end portion, a second end portion, and a compressible intermediate portion between the first end portion and the second end portion; and a tensioning member having a first tensioning-member end and a second tensioning-member end, defining a first segment and a second segment such that (i) the first segment extends between the first tensioning-member end and a turn of the tensioning member, and (ii) the second segment extends between the turn and the second tensioning-member end, wherein the tensioning member extends along the elongate member between the first end portion and the second end portion and is arranged such that the elongate member can slide relative to the tensioning member; and
- a catheter device configured to facilitate securing of the second end portion to the tissue, and to facilitate securing of the first end portion to the tissue subsequently to the securing of the second end portion to the tissue;
- wherein the tensioning member is coupled to the elongate member is such that applying tension to the tensioning member causes the elongate member to move from the elongate configuration to the shortened configuration by the tensioning member (i) pulling both the first end portion and the second end portion toward the intermediate portion, and (ii) compressing the intermediate portion, which can cause the implant to reshape an annulus of a heart valve.
Type: Application
Filed: Jun 29, 2020
Publication Date: Oct 22, 2020
Inventors: Hiroatsu Sugimoto (Cambridge, MA), Aaron M. Call (Mesa, AZ), Karl R. Leinsing (Hampton, NH)
Application Number: 16/915,989