ANNULOPLASTY SYSTEM AND SURGICAL METHOD

• US 20080065203A1
• Filed: 07/12/2007
• Published: 03/13/2008
• Est. Priority Date: 07/12/2006
• Status: Active Grant

• Current Assignee: Tigran Khalapyan
• Original Assignee: Tigran Khalapyan
• Inventors: Khalapyan, Tigran
• Granted Patent: US 7,799,073 B2
• Time in Patent Office: Days
• US Class Current: 623/2.11
• CPC Class Codes: A61B 17/0401 Suture anchors, buttons or pledgets, i.e. means for attaching sutures to bone, cartilage or soft tissue; Instruments for applying or removing suture anchors A61B17/0642 takes precedence; fixation devices for tendons or ligaments A61F2/0811
• CPC Class Codes: A61B 17/0467 Instruments for cutting sutures surgical cutting instruments A61B17/32
• CPC Class Codes: A61B 2017/00783 Valvuloplasty
• CPC Class Codes: A61B 2017/0406 Pledgets
• CPC Class Codes: A61B 2017/0456 Surface features on the anchor, e.g. ribs increasing friction between the suture and the anchor
• CPC Class Codes: A61B 2017/0458 Longitudinal through hole, e.g. suture blocked by a distal suture knot
• CPC Class Codes: A61B 2017/0464 for soft tissue
• CPC Class Codes: A61B 2017/0472 Multiple-needled, e.g. double-needled, instruments
• CPC Class Codes: A61B 2017/048 for reducing heart wall tension, e.g. sutures with a pad on each extremity
• CPC Class Codes: A61B 2017/0496 for tensioning sutures
• CPC Class Codes: A61F 2/2445 Annuloplasty rings in direct contact with the valve annulus

Abstract

An annuloplasty system for repairing incompetent heart valves is provided. This system includes a substantially circular valve reinforcing device adapted to be surgically implanted into around a heart valve annulus; anchoring means for attaching the substantially circular valve reinforcing device to the heart valve, wherein attaching the substantially circular valve reinforcing device to the heart valve annulus reduces the circumference of the heart valve annulus by plicating annular tissue underneath the valve reinforcing device; and constricting means for, if necessary, reducing the circumference of the substantially circular valve reinforcing device, wherein reducing the circumference of the substantially circular valve reinforcing device further reduces the circumference of the heart valve annulus.

Claims

1. ) An annuloplasty system for repairing incompetent heart valves, comprising:

(a) a substantially circular valve reinforcing device adapted to be surgically implanted around a heart valve annulus;

(b) anchoring means for attaching the substantially circular valve reinforcing device to the heart valve annulus, wherein attaching the substantially circular valve reinforcing device to the heart valve annulus reduces the circumference of the annulus by plicating annular tissue underneath the valve reinforcing device; and

(c) constricting means for reducing the circumference of the substantially circular valve reinforcing device, wherein reducing the circumference of the substantially circular valve reinforcing device further reduces the circumference of the heart valve annulus.

2. ) A method for surgically implanting an annuloplasty system, comprising:

(a) providing an annuloplasty system, wherein the annuloplasty system further includes;

(i) a substantially circular valve reinforcing device adapted to be surgically implanted around a heart valve annulus;

(ii) anchoring means for attaching the substantially circular valve reinforcing device to the heart valve annulus, wherein attaching the substantially circular valve reinforcing device to the heart valve annulus reduces the circumference of the annulus by plicating annular tissue underneath the valve reinforcing device; and

(iii) constricting means for reducing the circumference of the substantially circular valve reinforcing device, wherein reducing the circumference of the substantially circular valve reinforcing device further reduces the circumference of the heart valve annulus; and

(b) utilizing the anchoring means to secure the substantially circular valve reinforcing device to the heart valve annulus, wherein securing the substantially circular valve reinforcing device to the heart valve annulus reduces the circumference of the heart valve annulus by plicating annular tissue underneath the valve reinforcing device;

(c) testing repaired heart valve to verify that appropriate constriction has been achieved; and

(d) utilizing the constricting means to reduce the circumference of the substantially circular valve reinforcing device if appropriate constriction has not been achieved, wherein reducing the circumference of the substantially circular valve reinforcing device further reduces the circumference of the heart valve annulus.

3. ) An annuloplasty system for repairing incompetent heart valves, comprising:

(a) a substantially circular valve reinforcing device adapted to be surgically implanted around a heart valve annulus, wherein the valve reinforcing device further includes;

(i) a plurality of individual suture support segments, wherein the plurality of suture support segments further includes;

a) at least one anchor segment, wherein the at least one anchor segment further includes at least two channels passing lengthwise therethrough; and

b) a plurality of intermediate segments adapted to be implanted into the heart valve annulus after the anchor segment, wherein each intermediate segment further includes at least two channels passing lengthwise therethrough; and

(b) anchoring means for attaching the substantially circular valve reinforcing device to the heart valve annulus, wherein attaching the substantially circular valve reinforcing device to the heart valve annulus reduces the circumference of the annulus by plicating annular tissue underneath the valve reinforcing device, and wherein the anchoring means further includes;

(i) at least two sutures attached to the anchor segment, wherein at least one of the sutures includes a surgical needle attached thereto; and

(ii) at least two sutures attached to the intermediate segment wherein at least one of the sutures includes a surgical needle attached thereto; and

(c) constricting means for reducing the circumference of the substantially circular valve reinforcing device, wherein reducing the circumference of the substantially circular valve reinforcing device further reduces the circumference of the annulus, and wherein the constricting means further includes;

(i) at least two supportive drawstrings, wherein one end of each drawstring is attached to one end of the anchor segment, wherein each of the drawstrings passes through the channels in each intermediate segment, and wherein the ends of the drawstrings are tied together over the last intermediate segment after the heart valve repair is completed.

4. ) The annuloplasty system of claim 3, wherein the supportive drawstrings further includes suture material, biodegradable suture material, a Teflon strip, a band, a filament, a wire, a strap, or combinations thereof.

5. ) The annuloplasty system of claim 3, wherein the individual suture support segments are rigid or semi-rigid and are cylindrical, tubular, square, round, oval, or combinations thereof.

6. ) The annuloplasty system of claim 3, wherein the individual suture support segments are rigid or semi-rigid and resist bucking when the anchoring means are tied and reduce the potential of over-plication of annular tissue underneath the suture support segments when the anchoring means are tied.

7. ) The annuloplasty system of claim 3, wherein the individual suture support segments are radio-opaque, inert, non-corrosive, non-thrombogenic, and biocompatible with blood and tissue.

8. ) The annuloplasty system of claim 3, wherein the individual suture support segments further include a textured surface or coating for promoting tissue in-growth and reducing thromboembolism.

9. ) The annuloplasty system of claim 3, wherein the suture is stored within the suture support segment.

10. ) The annuloplasty system of claim 3, wherein the individual suture support segments contain an eye-like hole having a ratchet means for securing a suture, and wherein the suture can travel only in one direction in the eye-like hole.

11. ) The annuloplasty system of claim 3, wherein the individual suture support segments each contain an opening having a one-way suture retaining device, and wherein the one-way suture retaining device engages a braided suture for the purpose of tying.

12. ) The annuloplasty system of claim 3, wherein the individual suture support segments each contains an eye-like hole having a meltable polymeric material, wherein a suture is threaded through the eye-like hole, and wherein the polymeric material and suture are melted together to form a seal for the purpose of tying.

13. ) The annuloplasty system of claim 3, wherein the individual suture support segments contain a self-closing single-arm clip, and wherein the clip is U-shaped, C-shaped, or J-shaped.

14. ) A method for surgically implanting the annuloplasty system of claim 3, comprising:

(a) utilizing the anchoring means for securing the substantially circular valve reinforcing device to the heart valve annulus, wherein securing the valve reinforcing device to the heart valve annulus reduces the circumference of the annulus by plicating annular tissue underneath the valve reinforcing device, and wherein utilizing the anchoring means further includes;

(i) affixing the anchor segment to a dilated heart valve annulus by passing one of the surgical needles attached to the sutures on the anchor segment through the heart valve annulus;

(ii) pulling the suture and surgical needle which has passed through the heart annulus until the anchor segment aligns with the heart valve annulus;

(iii) securing the anchor segment to the heart valve annulus by tying the ends of the sutures on the anchor segment together;

(iv) using the supportive drawstrings to guide the intermediate segment through a minimally-invasive tube or small incision to the position above the heart valve annulus adjacent to the anchor segment;

(v) affixing the intermediate segment to the heart valve annulus by passing one of the surgical needles attached to the sutures on the intermediate segment through the heart valve annulus;

(vi) pulling the surgical needle and suture which has passed through the heart annulus until the intermediate segment aligns with the heart valve annulus;

(vii) securing the intermediate segment to the heart valve annulus by tying the ends of the sutures on the intermediate segment together;

(viii) repeating steps (iv)-(vii) until the desired circumference around the heart valve annulus is covered by intermediate suture support segments; and

(ix) testing the repaired heart valve to verify that appropriate constriction has been achieved; and

(b) utilizing the constricting means to reduce the circumference of the substantially circular valve reinforcing means, wherein reducing the circumference of the valve reinforcing device further reduces the circumference of the heart valve annulus by plicating the annular tissue between adjacent segments of the valve reinforcing device, and wherein utilizing the constricting means further includes;

(i) pulling both ends of the supportive drawstrings to the desired tension to further decrease the circumference of the heart valve annulus; and

(ii) tying the ends of the supportive drawstrings around the last intermediate segment.

15. ) An annuloplasty system for repairing incompetent heart valves, comprising:

(a) a substantially circular valve reinforcing device adapted to be surgically implanted around a heart valve annulus, wherein the valve reinforcing device further includes;

(i) a plurality of individual suture support segments, wherein the plurality of suture support segments further includes;

a) at least one anchor segment, wherein the at least one anchor segment further includes a channel passing lengthwise therethrough;

b) at least one terminal segment, wherein the at least one terminal segment further includes a channel passing lengthwise therethrough; and

c) a plurality of intermediate segments disposed between the at least one anchor segment and the at least one terminal segment, wherein each intermediate segment further includes a channel passing lengthwise therethrough; and

(b) anchoring means for attaching the substantially circular valve reinforcing device to the heart valve annulus, wherein attaching the valve reinforcing device to the heart valve annulus reduces the circumference of the annulus by plicating annular tissue underneath the valve reinforcing device, and wherein the anchoring means further includes;

(i) at least two sutures attached to the anchor segment, wherein at least one of the sutures includes a surgical needle attached thereto;

(ii) at least two sutures attached to the intermediate segment, wherein at least one of the sutures includes a surgical needle attached thereto; and

(iii) at least two sutures attached to the body portion of the terminal segment wherein at least one of the sutures includes a surgical needle attached thereto and a third suture attached to the end portion of the terminal segment for tying off the supportive drawstring following implantation; and

(c) constricting means for reducing the circumference of the substantially circular valve reinforcing device, wherein reducing the circumference of the valve reinforcing device further reduces the circumference of the annulus, and wherein the constricting means further includes;

(i) a supportive drawstring, wherein one end of the drawstring is attached to one end of the anchor segment, and wherein the supportive drawstring passes through the channel in each intermediate segment and the channel in the terminal segment.

16. ) The annuloplasty system of claim 15, wherein the supportive drawstring further includes suture material, biodegradable suture material, a Teflon strip, a band, a filament, a wire, a strap or combinations thereof.

17. ) The annuloplasty system of claim 15, wherein the individual suture support segments are rigid or semi-rigid and are cylindrical, tubular, square, round, oval, or combinations thereof.

18. ) The annuloplasty system of claim 15, wherein the individual suture support segments are rigid or semi-rigid and resist bucking when the anchoring means are tied and reduce the potential of over-plication of annular tissue underneath the suture support segments when the anchoring means are tied.

19. ) The annuloplasty system of claim 15, wherein the individual suture support segments are radio-opaque, inert, non-corrosive, non-thrombogenic, and biocompatible with blood and tissue.

20. ) The annuloplasty system of claim 15, wherein the individual suture support segments further include a textured surface or coating for promoting tissue in-growth and reducing thromboembolism.

21. ) The annuloplasty system of claim 15, wherein the suture is stored within the suture support segment.

22. ) The annuloplasty system of claim 15, wherein the individual suture support segments contain an eye-like hole having a ratchet means for securing a suture, and wherein the suture can travel only in one direction in the eye-like hole.

23. ) The annuloplasty system of claim 15, wherein the individual suture support segments each contain an opening having a one-way suture retaining device, and wherein the one-way suture retaining device engages a braided suture for the purpose of tying.

24. ) The annuloplasty system of claim 15, wherein the individual suture support segments each contains an eye-like hole having a meltable polymeric material, wherein a suture is threaded through the eye-like hole, and wherein the polymeric material and suture are melted together to form a seal for the purpose of tying.

25. ) The annuloplasty system of claim 15, wherein the individual suture support segments contain a self-closing single-arm clip, and wherein the clip is U-shaped, C-shaped, or J-shaped.

26. ) A method for surgically implanting the annuloplasty system of claim 15, comprising:

(a) utilizing the anchoring means for securing the substantially circular valve reinforcing device to the heart valve annulus, wherein securing the valve reinforcing device to the heart valve annulus reduces the circumference of the annulus by plicating annular tissue underneath the valve reinforcing device, and wherein utilizing the anchoring means further includes;

(i) affixing the anchor segment to a dilated heart valve annulus by passing one of the surgical needles attached to the sutures on the anchor segment through the heart valve annulus;

(ii) pulling the surgical needle and suture which has passed through the heart valve annulus until the anchor segment is aligned with the heart valve annulus;

(iii) securing the anchor segment to the heart valve annulus by tying the ends of the sutures together;

(iv) using the supportive drawstring to guide the intermediate segment through a minimally-invasive tube or small incision to the position above the heart valve annulus adjacent to the anchor segment;

(v) affixing the intermediate segment to the heart valve annulus by passing one of the surgical needles attached to the sutures on the intermediate segment through the heart valve annulus;

(vi) pulling the surgical needle and suture which has passed through the heart valve annulus until the intermediate segment aligns with the heart valve annulus;

(vii) securing the intermediate segment to the heart valve annulus by tying the ends of the sutures together;

(viii) repeating steps (iv)-(vii) until the desired circumference around the heart valve annulus is covered by intermediate suture support segments;

(ix) using the supportive drawstring to guide the terminal segment to the desired position above the heart valve annulus next to the last intermediate segment;

(x) affixing the terminal segment to the heart valve annulus by passing one of the surgical needles attached to the sutures on the terminal segment through the heart valve annulus;

(xi) pulling the surgical needle and suture which has passed through the heart valve annulus until the terminal segment is aligned with the heart valve annulus;

(xii) securing the terminal segment to the heart valve annulus by tying the ends of the sutures together; and

(xiii) testing the repaired heart valve to verify that appropriate constriction has been achieved; and

(b) utilizing the constricting means to reduce the circumference of the substantially circular valve reinforcing device if appropriate constriction has not been achieved, wherein reducing the circumference of the valve reinforcing device further reduces the circumference of the heart valve annulus by plicating the annular tissue between adjacent segments of the substantially circular valve reinforcing device, and wherein utilizing the constricting means further includes;

(i) pulling the supportive drawstring to the desired tension to further decrease the circumference of the heart valve annulus; and

(ii) tying the supportive drawstring that runs through the terminal segment to the third suture attached to the end portion of the terminal segment.

27. ) An annuloplasty system for repairing incompetent heart valves, comprising:

(a) a substantially circular valve reinforcing device adapted to be surgically implanted around a heart valve annulus, wherein the valve reinforcing device further includes;

(i) a plurality of individual suture support segments, wherein the plurality of suture support segments further includes;

a) at least one anchor segment covered with a sewing cuff, wherein the at least one anchor segment further includes a channel passing lengthwise therethrough;

b) at least one terminal segment covered with a sewing cuff, wherein the at least one terminal segment further includes a channel passing lengthwise therethrough; and

c) a plurality of intermediate segments disposed between the at least one anchor segment and the at least one terminal segment, wherein each intermediate segment is covered with a sewing cuff, and wherein each intermediate segment further includes a channel passing lengthwise therethrough; and

(b) anchoring means for attaching the substantially circular valve reinforcing device to the heart valve annulus, wherein attaching the valve reinforcing device to the heart valve annulus reduces the circumference of the annulus by plicating annular tissue underneath the valve reinforcing device, and wherein the anchoring means further includes;

(i) a dual-armed suture, wherein at least one end of the suture is attached to a surgical needle, and wherein the surgical needle passes through the sewing cuff of the anchor segment;

(ii) a dual-armed suture, wherein at least one end of the suture is attached to a surgical needle, and wherein the surgical needle passes through the sewing cuff of the intermediate segment; and

(iii) a dual-armed suture, wherein at least one end of the suture is attached to a surgical needle, and wherein the surgical needle passes through the sewing cuff of the terminal segment; and

(c) constricting means for reducing the circumference of the substantially circular valve reinforcing device, wherein reducing the circumference of the valve reinforcing device further reduces the circumference of the annulus, and wherein the constricting means further includes;

(i) a supportive drawstring, wherein one end of the drawstring is secured to one end of the anchor segment, wherein the supportive drawstring passes through the channel in each intermediate segment and the channel in the terminal segment.

28. ) The annuloplasty system of claim 27, wherein the supportive drawstring further includes suture material, biodegradable suture material, a Teflon strip, a band, a filament, a wire, a strap or combinations thereof.

29. ) The annuloplasty system of claim 27, wherein the individual suture support segments are rigid or semi-rigid and are cylindrical, tubular, square, round, oval, or combinations thereof.

30. ) The annuloplasty system of claim 27, wherein the individual suture support segments are rigid or semi-rigid and resist bucking when the anchoring means are tied and reduce the potential of over-plication of annular tissue underneath the suture support segments when the anchoring means are tied.

31. ) The annuloplasty system of claim 27, wherein the individual suture support segments are radio-opaque, inert, non-corrosive, non-thrombogenic, and biocompatible with blood and tissue.

32. ) The annuloplasty system of claim 27, wherein the individual suture support segments further include a textured surface or coating for promoting tissue in-growth and reducing thromboembolism.

33. ) A method for surgically implanting the annuloplasty system of claim 27, comprising:

(a) utilizing the anchoring means for securing the substantially circular valve reinforcing device to the heart valve annulus, wherein securing the valve reinforcing device to the heart valve annulus reduces the circumference of the heart valve annulus by plicating annular tissue underneath the valve reinforcing device, and wherein utilizing the anchoring means further includes;

(i) affixing the suture to the heart valve annulus by passing one of the surgical needles attached to the sutures through the heart valve annulus;

(ii) threading the surgical needles attached to the suture through the sewing cuff of the anchor segment;

(iii) pushing the anchor segment down over the strands of the suture until the anchor segment is aligned with the heart valve annulus;

(iv) securing the anchor segment to the heart valve annulus by tying the ends of the sutures together;

(v) affixing another suture to a incompetent heart valve annulus as a horizontal mattress stitch by passing one of the surgical needles attached to the sutures through the heart valve annulus;

(vi) threading the surgical needles attached to the suture through the sewing cuff on the first intermediate segment;

(vii) using the supportive drawstring and the strands of the suture to guide the intermediate segment to the desired position above the heart valve annulus;

(viii) pushing the intermediate segment down the suture strands until the intermediate segment is aligned with the heart valve annulus;

(ix) securing the intermediate segment to the heart valve annulus by tying the ends of the sutures together;

(x) repeating steps (v)-(ix) until the desired circumference around the heart valve annulus is covered by intermediate suture support segments;

(xi) threading the supportive drawstring through the channel which passes through the length of the terminal segment;

(xii) affixing the suture to a heart valve annulus by passing one of the surgical needles attached to the sutures through the heart valve annulus;

(xiii) threading the surgical needles attached to the suture through the sewing cuff on the terminal segment;

(xiv) using the supportive drawstring and the strands of the suture to guide the terminal segment to the desired position above the heart valve annulus;

(xv) pushing the terminal segment down over the strands of the sutures until the terminal segment is aligned with the heart valve annulus;

(xvi) securing the terminal segment to the heart valve annulus by tying the ends of the sutures together; and

(xvii) testing the repaired heart valve to verify that appropriate; and

(b) utilizing the constricting means to reduce the circumference of the substantially circular valve reinforcing device, wherein reducing the circumference of the valve reinforcing device further reduces the circumference of the heart valve annulus by plicating the annular tissue between adjacent segments of the substantially circular valve reinforcing device, and wherein utilizing the constricting means further includes;

(i) pulling the supportive drawstring to the desired tension to decrease the circumference of the heart valve annulus; and

(ii) tying the supportive drawstring that runs through the terminal segment to the third suture attached to the end portion of the terminal segment.

34. ) An annuloplasty system for repairing incompetent heart valves without traditional knotting, comprising:

(a) a substantially circular flexible valve reinforcing device adapted to be surgically implanted into a heart valve annulus, wherein the valve reinforcing device further includes a core formed of a plurality of thin fibers which are held together by a tubular polyester velour cloth; and

(b) anchoring means for attaching the substantially circular valve reinforcing device to the heart valve annulus and for pleating the annulus to reduce its circumference to substantially that of the valve reinforcing device, wherein the anchoring means further includes;

(i) a suture containing at least one surgical needle at each proximal end of the suture; and

(ii) a plurality of barbed structures formed at a medial point on the suture with a first barb structure being placed a distance away from a second barb structure to create a bridge area, wherein the first barbed structure is oriented to permit passage of the suture through the heart valve annulus in a forward direction and prevent movement in a reverse direction, and wherein the second barbed structure is oriented to prevent passage of the suture through the heart valve annulus in a forward direction.

35. ) A method for surgically implanting the annuloplasty system of claim 34, comprising:

(a) utilizing the anchoring means to secure the substantially circular valve reinforcing device to the heart valve annulus, wherein utilizing the anchoring means further includes;

(i) inserting one of the surgical needles of the suture apparatus into the heart valve annulus and pulling the surgical needle which draws the first portion of the suture through the heart valve annulus until the barbs of the second barbed structure engage the surface of the annulus at the insertion point preventing further advancement of the suture into the heart valve annulus;

(ii) inserting another suture apparatus into the heart valve annulus 2-4 mm apart from the previous stitch and pulling the surgical needle which draws the first portion of the suture through the heart valve annulus until the barbs of the second barbed structure engage the surface of the heart valve annulus at the insertion point preventing further advancement of the suture into the heart valve annulus;

(iii) repeating step (ii) until the entire circumference of the posterior annulus of the heart valve is evenly sutured;

(iv) using both surgical needles of each of the suture apparatus to pierce the annuloplasty ring wherein the suture attached to the surgical needles lower the annuloplasty ring over the sutures into position above the heart valve annulus;

(v) pushing the annuloplasty ring onto the barbed structures wherein the barbed structures catch the thin fibers in the annuloplasty ring;

(vi) using the barbed structures to hold the annuloplasty ring into place; and

(vii) cutting off the surgical needles and the remaining suture material.