APPARATUS AND METHODS FOR IN-HEART VALVE SURGERY

Abstract

An annuloplasty ring is provided including a core defining a closed ring and comprising one or more flexible portions, wherein the core is capable of deformation about the flexible portion between a first configuration and a second configuration upon application of a predetermined force; a resilient intermediate layer; and a fabric cover layer.

Claims

1. An annuloplasty ring comprising: a core defining a closed ring and comprising one or more flexible portions, wherein the core is capable of deformation about the flexible portion between a first configuration and a second configuration upon application of a predetermined force; a resilient intermediate layer; and a fabric cover layer.

2. The annuloplasty ring of claim 1, wherein the flexible portions of the core comprise polymer.

3. The annuloplasty ring of claim 1, wherein the flexible portions of the core comprise a metallic coil.

4. The annuloplasty ring of claim 1, wherein the core comprises a plurality of metal wires.

5. The annuloplasty ring of claim 4, wherein the wires are fabricated of Elgiloy or Nitinol.

6. The annuloplasty ring of claim 1, wherein the core comprises titanium.

7. The annuloplasty ring of claim 1, wherein the core comprises PEEK.

8. The annuloplasty ring of claim 1, wherein the intermediate layer comprises polymer or rubber.

9. An annuloplasty ring comprising: a core defining a closed ring and comprising one or more weakened portions, wherein breakage of the weakened portions upon application of a predetermined force causes deformation between a first configuration and a second configuration; a resilient intermediate layer; and a fabric cover layer.

10. The annuloplasty ring of claim 9, wherein the weakened portions of the core comprise a smaller dimension than adjacent portions of the core.

11. The annuloplasty ring of claim 9, wherein the weakened portions of the core define a plurality of perforations therethrough.

12. The annuloplasty ring of claim 9, wherein the weakened portions of the core comprise a more brittle material than adjacent portions of the core.

13. The annuloplasty ring of claim 9, wherein the weakened portions of the core comprise a softer material than adjacent portions of the core.

14. The annuloplasty ring of claim 9, wherein the core comprises a plurality of metal wires.

15. The annuloplasty ring of claim 14, wherein the wires are fabricated of Elgiloy or Nitinol.

16. The annuloplasty ring of claim 9, wherein the core comprises titanium.

17. The annuloplasty ring of claim 9, wherein the core comprises PEEK.

18. An annuloplasty attachment for use with an annuloplasty ring comprising: a body portion defining end portions and a plurality of engagement members for securement to the annular tissue; and connection members disposed at each end portions of the body portion for connection with the end portions of an incomplete annuloplasty ring.

19. The annuloplasty attachment of claim 18, wherein the connection members are eyelets configured for suturing to the end portions of the incomplete annuloplasty ring.

20. The annuloplasty attachment of claim 18, wherein the engagement members are barbs, tines or anchors.

Description

BRIEF DESCRIPTION OF THE DRAWINGS

[0030] A detailed description of various aspects, features, and embodiments of the subject matter described herein is provided with reference to the accompanying drawings, which are briefly described below. The drawings are illustrative and are not necessarily drawn to scale, with some components and features being exaggerated for clarity. The drawings illustrate various aspects and features of the present subject matter and may illustrate one or more embodiment(s) or example(s) of the present subject matter in whole or in part.

[0031] FIG. 1 is a schematic representation of a mitral valve of a human heart.

[0032] FIG. 2 is a schematic representation of a tricuspid valve of a human heart.

[0033] FIG. 3 is elevation view of an annuloplasty ring in accordance with an exemplary embodiment of the disclosed subject matter.

[0034] FIG. 4 is an enlarged view of the annuloplasty ring of FIG. 4 in partial cross-section.

[0035] FIG. 5 is an elevation view of an annuloplasty ring in accordance with another exemplary embodiment of the disclosed subject matter.

[0036] FIG. 6 is an enlarged cross-sectional view of an annuloplasty ring in accordance with a further embodiment of the disclosed subject matter.

[0037] FIG. 7 is an elevation view of an annuloplasty ring in accordance with another exemplary embodiment of the disclosed subject matter in a first configuration with the parts intact.

[0038] FIG. 8 is an elevation view of an annuloplasty ring in accordance with the exemplary embodiment of FIG. 7 in a second configuration with the parts separated.

[0039] FIG. 9 is elevation view of an annuloplasty attachment for attachment to an incomplete annuloplasty ring in accordance with an exemplary embodiment of the disclosed subject matter.

[0040] FIG. 10 illustrates the annuloplasty attachment of FIG. 9 attached to an incomplete annuloplasty ring disposed at the mitral valve of a human subject.

[0041] FIG. 11 illustrates the annuloplasty attachment of FIG. 9 attached to an incomplete annuloplasty ring disposed at the tricuspid valve of a human subject.

[0042] FIG. 12 is an elevation view of an annuloplasty attachment for attachment to an incomplete annuloplasty ring in accordance with another exemplary embodiment of the disclosed subject matter.

[0043] FIG. 13 is an elevation view of an annuloplasty attachment for attachment to an incomplete annuloplasty ring in accordance with a further exemplary embodiment of the disclosed subject matter.

[0044] FIG. 14 is an elevation view of an annuloplasty attachment pre-attached to an incomplete annuloplasty ring in accordance with a still further exemplary embodiment of the disclosed subject matter.

[0045] FIG. 15 is a cross-section view of the human heart, illustrating the annuloplasty attachment and an incomplete annuloplasty ring attached the heart.

[0046] FIG. 16 is a cross-section view of the human heart, illustrating an incomplete annuloplasty ring attached the heart and artificial replacement valve.

[0047] FIG. 17 is an elevation view illustrating an incomplete annuloplasty ring and an artificial replacement valve.

[0048] FIG. 18 is a cross-section view of the human heart, illustrating an annuloplasty attachment and an incomplete annuloplasty ring attached the heart along with an artificial replacement valve.

[0049] FIG. 19 is an elevation view illustrating an annuloplasty attachment and an incomplete annuloplasty ring along with an artificial replacement valve.

DETAILED DESCRIPTION

[0050] Reference will now be made in detail to select embodiments of the disclosed subject matter, examples of which are illustrated in the accompanying drawings. The method and corresponding steps of the disclosed subject matter will be described in conjunction with the detailed description of the system.

[0051] Unless defined otherwise, all technical and scientific terms used herein have the same meaning as commonly understood by one of ordinary skill in the art to which this disclosed subject matter belongs. Although any methods and materials similar or equivalent to those described herein can also be used in the practice or testing of the present disclosed subject matter, this disclosure may specifically mention certain exemplary methods and materials.

[0052] As used herein and in the appended claims, the singular forms “a,” “an,” and “the” include plural referents unless the context clearly dictates otherwise.

[0053] In accordance with the various embodiments of the disclosed subject matter, annuloplasty rings or devices for use in heart surgery are disclosed herein. More particularly, annuloplasty rings, devices and methods are provided for their use in heart valve repair surgery.

[0054] In some embodiments, the rings have rigid or semi rigid construction, and include a core fabricated of metal such as Elgiloy/Nitinol/Titanium and/or polymer such as PEEK, and can be easily molded in to any desired shape and will retain the shape when implanted during mitral and tricuspid repair.

[0055] When manufactured there may be high pressure sensitive points along the circumference of the ring which can allow a complete or partial break, and thus the ring adapting a circular shape. If the ring is made from an alloy, the joints used to secure the wire or wires can be either distributed to avoid overlap or made of a design such that it can be made circular.

[0056] The construction described herein allows the ring to be made of desired rigidity i.e., rigid or semi rigid, such that when it is manufactured and implanted, it can retain its desired first shape or configuration throughout the life cycle of the ring, thus, the ring will not change its shape or size after implantation. Moreover, if there is a need for valve-in-ring (VIR) procedure, the ring can be easily forced in to a second shape or configuration, e.g., a substantially circular shape, during a surgical procedure. Thus the design described herein provides good anchor by nature of its components, and also optimal shape of the transcatheter heart valve (THV) so as to achieve durable long term result.

[0057] The annuloplasty ring includes a core forming a closed ring, typically fabricated of metal such as Elgiloy, Nitinol or Titanium; an intermediate layer of resilient material, such as polymer or rubber. An outer layer is a fabric material applied over the intermediate layer of polymer or rubber. The core is configured to be deformed between a first configuration and a second configuration.

[0058] Rigidity is determined for the particular surgical need, and is property dependent on the nature of metal and its configuration. For example, in some embodiments, the core is fabricated from metal, e.g., titanium sheet or thick wire. Consequently, the ring will be rigid in structure and will maintain the shape irrespective of force applied to it from within. In other embodiments, the core is made of multiple thinner wires of Elgiloy or Nitinol. In this embodiment, the ring may become semi-rigid and allow a deformation to nearly circular shape.

[0059] In some embodiments, the core is made of a polymer such as PEEK. PEEK is known to be extremely rigid without increasing bulk. The PEEK material is molded in any shape and can be adapted to all existing rigid ring shapes. Annuloplasty rings in accordance with some embodiments, include a core fabricated from PEEK, which is covered by an intermediate layer of silastic or any other material similar to current rings, and then covered by an outer layer of fabric. The rigidity of the ring at the time of implant in its initial configuration remains unchanged. There are inherent areas of weakness or flexion which are incorporated within the PEEK structure. These will allow the ring to break/deform from a first configuration to a second configuration when a predetermined level of force is applied to the ring. The second configuration can be (a) substantially circular; (b) expand in size; or (c) provide an appropriate shape to anchor an implanted artificial valve.

[0060] In some embodiments, a semi rigid ring is described. According to the this embodiment, a combination of polymer and metal alloy can achieve semi rigidity to allow similar degree of ring motion with mitral valve motion as the current rings, The construction will allow the ring to assume circular shape after VIR. This is achieved as described below.

[0061] As illustrated in FIGS. 3 and 4, an embodiment of the ring 10 includes an anterior portion 12 and posterior portion 14. Ring 10, which includes a plurality of wires 18 in its construction, eliminates the anterior joint of conventional rings where wire forms are welded or joint together. FIG. 4 illustrates that the usual joint is replaced by polymer section 16 used to connect the wires 18. The polymer piece 16 is capable of controlled breakage by the surgeon when the applied force exceed a predetermined threshold. Upon application of the force, the ring 10 can assume a second configuration as described above. The ring 10 is covered with an outer layer 16 including polymer or rubber surrounded by fabric. The outer layers 16 serve two purposes, they provide a biocompatible and atraumatic covering from the core 18, and also following breakage of the polymer section 15 maintain the integrity of the closed ring shape.

[0062] As illustrated in FIG. 5, another embodiment of the ring 20 include a core 28 having a plurality wires and a plurality of welding joints or polymer section 25 in various wire forms at different locations to avoid overlap of the welding points. This configuration allows the surgeon to impose circularity during VIR by applying a predetermined force to move the core 28 to its second configuration, e.g., a circular or expanded configuration. The ring 20 is covered with an outer layer 26 including polymer or rubber surrounded by fabric.

[0063] As illustrated in FIG. 6, a further embodiment of the ring 30 includes a core 38 having wires that are each joined with a coil 39. The configuration of ring 30 maintains a degree of semi rigidity when implanted in its initial configuration, but is capable of being molded to circular shape by application of a predetermined force by the surgeon. The ring 30 is covered with an outer layer 36 including polymer or rubber surrounded by fabric.

[0064] As illustrated in FIGS. 7 and 8, another embodiment of the ring 40 is described in which the core is constructed from a rigid polymer and includes predesigned weak spots 44a-44h. In some embodiments, the weakness is provided by e.g., including a plurality of perforation therethrough; by making the weak spots narrower or smaller than adjacent portions of the core, by using a more brittle or softer material for the weak spots than the adjacent core material, etc. When applies pressure from within exceeds a predetermined threshold (arrows P), the weak spots 44a-44h will break fully or partially, separating the ring into sections 42a-42h to make the ring circular. (FIG. 8) The ring 40 is covered with an outer layer 46 including polymer or rubber surrounded by fabric. As discussed above, the outer layers 46 help maintain the integrity of the closed ring shape after breakage of the weakened spots.

[0065] The same ring designs described herein will work in Tricuspid position as well with no change in functionality.

[0066] Another embodiment is disclosed herein is an attachment that is used to fill the gap in incomplete or broken rings in valve repair surgery. Most particularly, this is a novel attachment to be used in mitral valve and tricuspid valve repair surgery, whereby the attachment fills the gap between the two ends of an open/incomplete ring. The shape and function of the implanted ring is unaltered. However, by implanting this attachment, the assembly of the ring and the attachment will behave like a complete ring during a valve-in-ring (VIR) procedure.

[0067] The attachment described herein effectively converts an incomplete or partial ring on mitral and tricuspid side to a complete ring without the need of suturing and risk of altering shape of the annulus or damage to neighboring structure such as conduction tissue. The ring attachment is used as a separate attachment or as part of the incomplete band. The design could take one of the following embodiments.

[0068] Attachment 200 is illustrated in FIG. 9, and is used to bridge the gap between the ends of an incomplete ring or band. As described herein, an incomplete ring or band refers to ring having two free ends and which does provide a closed ring shape. Attachment 200 includes eyelets 202 at each end that are used to secure the attachment 200 to the two ends of the ring or band, as described below. Attachment may be made by passing a single suture through the eyelets and the existing ring or band. The attachment 200 further includes tines/hooks/barbs 204 to embed themselves in the annular tissue.

[0069] FIG. 10 illustrates attachment 200 bridging the gap between two ends 206/208 of the incomplete ring or band 210 at the mitral valve. The orientation of the attachment 200 and the ring 210 relative to the anterior mitral leaflet (AML) and posterior mitral leaflet (PML) is shown. The attachment 200 is tied in place concurrently with the implantation of the incomplete ring/band 210 or afterwards. The length of the attachment 200 and shape could be predetermined to fit a particular type and size of the ring as the gap between the ends of incomplete ring 202 is known. Ring 210 is secured to the annular tissue via sutures 212.

[0070] FIG. 11 illustrates attachment 200 bridging the gap between two ends 206/208 of the incomplete ring or band 210 at the tricuspid valve. The orientation of the attachment 200 and the ring 210 relative to the anterior tricuspid leaflet (ATL), the septal tricuspid leaflet (STL) and posterior tricuspid leaflet (PTL) is shown. The attachment 200 is secured to the ring 200 in the same manner as described above.

[0071] The attachment may not need additional suturing as it is held in place and is engaged with the annulus (anterior annulus in case of the Mitral valve and the open space in case of Tricuspid valve) with help of anchors. The anchors could be barbs of varying length and direction, tines, or anchors. FIG. 12 illustrates an embodiment of attachment 300 in which hooks 304 are driven though the attachment and into tissue.

[0072] FIG. 13 illustrates an embodiment of attachment 400 with an expandable portion 411 that can be used to adjust the length of the attachment 400. The expandable portion, which can be a coiled spring, allows for the attachment 400 to be elongated if and when needed.

[0073] As illustrated in FIG. 14, the existing band 510 can include a pre-attached anterior element 500. The element 500 resembles the attachment 200, 300, 400 described above. Such attachment portion 500 is preattached to the ring/band 510, such that the ends 502 of the attachment 500 are secured to the ends 506/508 of the ring/band 510. After suturing the ring/band 510 posteriorly, the anterior element 500 can be pushed in to the anterior annulus and secured thereto by use of the tines/barbs/anchors 504 as discussed above.

[0074] With time the attachment will get embedded in the tissue with time and will allow extra support to the anterior annulus during a Valve-in-ring procedure in future. FIG. 15 is a cross-section of the heart, which illustrates the relationship of the attachment and the incomplete ring/band in connection to the mitral valve (MV) including the anterior mitral leaflet (AML) and posterior mitral leaflet (PML). FIG. 15 illustrates that attachment 200 is embedded in the anterior annulus, and the incomplete ring/band 210 is sutured to the posterior annulus.

[0075] FIGS. 16 and 17 illustrate a heart that is not suitable for transcatheter aortic valve implantation (TAVI) because there is no anterior anchoring of the band/ring 210. FIGS. 18 and 19 illustrate a heart that is more suitable for TAVI due to the anterior anchoring of the band/ring 210 by use of attachment 200 providing a stable base for the valve.

[0076] It is understood that the subject matter described herein is not limited to particular embodiments described, as such may, of course, vary. For example, the exemplary embodiments describe above are not limited to fine needle aspiration applications. Instead the disclosed subject matter is applicable to additional clinical settings such as processing small surgical biopsies (less than 2 cm), in research laboratories for isolating cells from bone marrow diluted by blood, analyzing small samples of engineered tissues, and purifying cells in a spin column. Accordingly, nothing contained in the Abstract or the Summary should be understood as limiting the scope of the disclosure. It is also understood that the terminology used herein is for the purpose of describing particular embodiments only, and is not intended to be limiting. Where a range of values is provided, it is understood that each intervening value between the upper and lower limit of that range and any other stated or intervening value in that stated range, is encompassed within the disclosed subject matter.