# Patent

## Title
Annuloplasty instrument

## Abstract

A device for repairing a heart valve comprises an implantation instrument. The implantation instrument comprises a first support ring, and a second support ring connected to said first support ring to form a coiled configuration. The first support ring is configured to abut one side of the valve and the second support ring is configured to abut an opposite side of the valve to thereby trap a portion of the valve tissue therebetween. The device further comprises an annuloplasty implant adapted to be attached to the heart valve annulus in order to reshape the annulus and allow the leaflets to open and close properly. The annuloplasty implant is connected to the implantation instrument for insertion to the annulus.

## Background
This application is a continuation-in-part of application Ser. No. 10/787,581, filed on Feb. 26, 2004 now U.S. Pat. No. 6,964,684 (pending) which is a divisional of application Ser. No. 10/145,416 filed on May 14, 2002 (now U.S. Pat. No. 6,730,121) which is a divisional of application Ser. No. 09/610,784 filed Jul. 6, 2000 (now U.S. Pat. No. 6,419,696), the disclosures of which are fully incorporated herein by reference.


FIELD OF THE INVENTION
The present invention generally relates to heart valve repair and replacement techniques and annuloplasty devices. More specifically, the invention relates to the repair of heart valves having various malformations and dysfunctions.
BACKGROUND OF THE INVENTION
Diseased mitral and tricuspid valves frequently need replacement or repair. The mitral and tricuspid valve leaflets or supporting chordae may degenerate and weaken or the annulus may dilate leading to valve leak (insufficiency). The leaflets and chords may become calcified and thickened rendering them stenotic (obstructing forward flow). Finally, the valve relies on insertion of the chordae inside the ventricle. If the ventricle changes in shape, the valve support may become non-functional and the valve may leak.
Mitral and tricuspid valve replacement and repair are traditionally performed with a suture technique. During valve replacement, sutures are spaced around the annulus (the point where the valve leaflet attaches to the heart) and then the sutures are attached to a prosthetic valve. The valve is lowered into position and when the sutures are tied, the valve is fastened to the annulus. The surgeon may remove all or part of the valve leaflets before inserting the prosthetic valve. In valve repair, a diseased valve is left in situ and surgical procedures are performed to restore its function. Frequently an annuloplasty ring is used to reduce the size of the annulus. The ring serves to reduce the diameter of the annulus and allow the leaflets to oppose each other normally. Sutures are used to attach a prosthetic ring to the annulus and to assist in plicating the annulus.
In general, the annuloplasty rings and replacement valves must be sutured to the valve annulus and this is time consuming and tedious. If the ring is severely malpositioned, then the stitches must be removed and the ring repositioned relative to the valve annulus during restitching. In other cases, a less than optimum annuloplasty may be tolerated by the surgeon rather than lengthening the time of the surgery to restitch the ring.
During heart surgery, a premium is placed on reducing the amount of time used to replace and repair valves as the heart is frequently arrested and without perfusion. It would therefore be very useful to have a method to efficiently attach a prosthesis into the mitral or tricuspid valve position.
SUMMARY OF THE INVENTION
It is an object of the invention to provide a more reliable and more easily accomplished valve repair. It is a specific object of the invention to facilitate insertion of an annuloplasty implant.
These and other objects of the invention are accomplished by means of a device, a kit and a method according to the independent claims. Preferred embodiments of the invention are apparent from the dependent claims.
Thus, according to a first aspect of the invention, a device is provided for repairing a heart valve comprised of valve tissue including an annulus and a plurality of leaflets for allowing and preventing blood flow through a patient's heart. The device comprises an implantation instrument, which comprises a first support ring, and a second support ring connected to the first support ring to form a coiled configuration. The first support ring is configured to abut one side of the valve and the second support ring is configured to abut an opposite side of the valve to thereby trap a portion of the valve tissue, that is, annulus tissue and/or leaflet tissue, therebetween. The device further comprises an annuloplasty implant adapted to be attached to the heart valve annulus in order to reshape the annulus and allow the leaflets to open and close properly.
The implantation instrument is applied to the heart valve in a much easier manner than conventionally utilized annuloplasty rings. By means of the implantation instrument it is possible to fixate the valve annulus and primarily reshape it. This primary reshaping of the valve annulus facilitates attachment of the annuloplasty implant to the valve annulus. There is merely a need for a slight further reshaping of the valve annulus by the attachment of the annuloplasty implant in order to achieve the desired shape of the valve annulus. Since the attachment of the annuloplasty implant need not dramatically change the shape of the valve annulus, the possibility of correctly positioning the annuloplasty implant is greatly increased. This implies that there is a very slim risk that the annuloplasty implant will need to be repositioned. Further, by means of the device the desired reshaping of the valve annulus may in most cases be achieved.
The invention contemplates various embodiments of the device, including embodiments for catheter-based surgery and embodiments for open heart surgery.
The first and second support rings may have generally triangular-shaped cross sections with flat sides opposing one another and trapping valve tissue therebetween.
At least the opposed surfaces of the first and second support rings may be roughened, such as by the use of fabric, coatings, knurling or the like to facilitate better engagement and retention of the support rings on the valve tissue. The opposed surfaces may be roughened in a pattern extending along the longitudinal direction of the rings. This implies that the roughened surface will serve to prevent slippage of tissue through the ring while presenting a low friction for the ring to be turned into position abutting the valve. The implantation instrument may have an inherent shape where the first and second rings contact or nearly contact each other. Thus, the implantation instrument will present a spring force pushing the first and second rings towards each other. The spring force will make the first and second rings fixating valve tissue between them.
Preferably, the first and second support rings are formed integrally from a coiled rod, such as a metallic rod, with one end of the rod formed as a leading end and one end formed as a trailing end. These ends may be bent in opposite directions so that the leading end may be directed through the valve tissue and the trailing end may be grasped by an appropriate surgical implement. A carrier may be used to rotate the implantation instrument into position on opposite sides of the valve annulus. As another alternative, the carrier may be coil-shaped and the implantation instrument may be rotated into place on only one side of the valve annulus similar to conventional rings. The carrier may also be rotated in opposite direction for withdrawing the implantation instrument. The first and second support rings may be adjustable in diameter to allow adjustment of the valve annulus.
The annuloplasty implant may have an arcuate shape conforming to a desired arcuate shape of a portion of the annulus. The annuloplasty implant may then be attached to the portion of the valve annulus for reshaping the valve annulus. The desired reshaping of the valve annulus may be achieved by the annuloplasty implant reshaping only a portion of the valve annulus. Thus, the annuloplasty implant may be C- or U-shaped. The annuloplasty implant may alternatively have a ring-shape conforming to the desired shape of the annulus. The annuloplasty implant may thus be attached to the valve annulus forcing it to assume the desired shape.
The annuloplasty implant may be removably attached to the second support ring of the implantation instrument. The annuloplasty implant may then be detached from the implantation instrument after being attached to the valve annulus. The implantation instrument may thereafter be removed from the patient. The annuloplasty implant may be attached to the second support ring by means of a removable suture. The suture may be cut in order to detach the annuloplasty implant from the implantation instrument.
According to a second aspect of the invention, a kit is provided for repairing a heart valve comprised of valve tissue including an annulus and a plurality of leaflets for allowing and preventing blood flow. The kit comprises an implantation instrument, which comprises a first support ring, and a second support ring connected to the first support ring to form a coiled configuration. The first support ring is configured to abut one side of the valve and the second support ring is configured to abut an opposite side of the valve to thereby trap a portion of the valve tissue therebetween. The kit further comprises an annuloplasty implant adapted to be attached to the heart valve annulus in order to reshape the annulus and allow the leaflets to open and close properly.
The annuloplasty implant need not be attached to the implantation instrument for being inserted to the heart valve. The implantation instrument may provide the primary reshaping of the valve annulus. The annuloplasty implant may then be separately inserted to permanently reshape the valve annulus. The correct positioning of the annuloplasty implant is now easily achieved since the primary reshaping of the valve annulus provided by the implantation instrument clearly indicates how the annuloplasty implant should be attached to the valve annulus.
According to a third aspect of the invention, a method is provided for repairing a heart valve comprised of valve tissue including an annulus and a plurality of leaflets for allowing and preventing blood flow. The method comprises inserting an implantation instrument comprising a first and a second support ring connected to each other to form a coiled configuration, said instrument being inserted such that valve tissue is trapped between the first and second support rings, attaching an annuloplasty implant to the annulus in order to reshape it, and removing the implantation instrument.
The step of inserting the instrument may comprise temporarily reshaping the annulus to facilitate attachment of the annuloplasty implant to the annulus. Thus, the implantation instrument will guide the positioning of the annuloplasty implant.
The step of inserting may further comprise inserting a first end of the first support ring through a portion of the valve tissue, rotating the implantation instrument to position the first support ring on a first side of the valve, and positioning the second support ring on an opposite second side of the valve. The first and second support ring are thus easily applied on opposite sides of the valve.
Various additional objectives, advantages and features of the invention will become more readily apparent to those of ordinary skill in the art upon review of the detailed description of the illustrative embodiments.



BRIEF DESCRIPTION OF THE DRAWINGS
FIG. 1 schematically illustrates a patient with a heart shown in cross section and a device of the present invention schematically illustrated as supporting the mitral valve.
FIG. 1A is a cross sectional view of the left ventricle showing the mitral valve and a device of the invention in perspective.
FIG. 2 is a perspective view of a device according to an embodiment of the invention.
FIG. 3 is a cross sectional view of the device in FIG. 2.
FIG. 3A is a fragmentary perspective view, partially in cross-section, further illustrating one of the support rings shown in FIG. 3.
FIG. 3B is a fragmentary perspective view, partially in cross-section, illustrating alternate support rings according to the present invention.
FIG. 3C is a perspective view illustrating alternate support rings with a surface of the ring coated with a cushioning material.
FIG. 3D is an enlarged view of encircled portion “3D” shown in FIG. 3C.
FIGS 4A–4B are partially sectioned perspective views of the mitral valve and the device of the invention during implantation of an annuloplasty implant of the device.
FIG. 5 is a partially sectioned perspective view showing the device of the invention when the implantation instrument has been turned into position.
FIG. 6 is a cross-sectional view illustrating primary reshaping of the valve.
FIG. 7 is a partially sectioned perspective view showing the device when the annuloplasty implant is being attached to the valve annulus.
FIG. 8 is a perspective view showing the device after implantation is completed.



DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENTS
FIG. 1 illustrates a patient 10 having a heart 12 shown in cross section including a left ventricle 14 and a right ventricle 16. The concepts of the present invention are suitable to be applied, for example, to a mitral valve 18 which supplies blood into left ventricle 14. Mitral valve 18, as better shown in FIG. 1A, includes an annulus 20 and a pair of leaflets 22, 24 which selectively allow and prevent blood flow into left ventricle 14. It will be appreciated that the term annulus tissue is used extensively throughout this disclosure in reference to the drawings, however, the inventive principles are equally applicable when referring to other valve tissue such as leaflet tissue or other attached vessel tissue. Leaflets 22, 24 are supported for coaptation by chordae tendinae or chords 26, 28 extending upwardly from respective papillary muscles 30, 32. Blood enters left ventricle 14 through mitral valve 18 and is expelled during subsequent contraction of heart 12 through aortic valve 34. It will be appreciated that the present invention is applicable to tricuspidal heart valves as well.
A preferred device of the present invention is shown in FIGS 2 and 3. The device comprises an implantation instrument 40 which comprises a first and a second support ring 42, 44 assuming a coiled configuration in the form of a spiral or keyring-type configuration. Any suitable medical grade material(s), such as medical grade metals or plastics, may be used to form the implantation instrument 40. The device is shown in cross section in FIG. 3. The implantation instrument 40 has a traditional cross sectional shape associated with a keyring. In this embodiment flat, opposed surfaces 46 are arranged to trap valve annulus tissue 20 therebetween. The opposed surfaces 46 may also be roughened in order to improve engagement with the valve annulus 20. The roughened surface 46 of the first support ring 42 is illustrated further in FIG. 3A. An alternate elongate support member or implantation instrument 70 is shown in FIG. 3B. This embodiment has a traditional cross-sectional shape associated with a keyring. In this embodiment flat, opposed surfaces 72 trap valve annulus tissue 20 therebetween.
FIGS. 3C and 3D illustrate another alternate valve support member or implantation instrument 90 in the shape of a coil or keyring. This embodiment also illustrates retaining members 92 in the form of small threaded fasteners. As shown best in FIG. 3D, a coating of softer cushioning material 94. 96 may be applied to surfaces of the coil member 90 which oppose one another and contact opposite sides of the valve annulus (not shown). In addition to cushioning the contact areas with the annulus tissue, these coatings may provide additional friction to retain the instrument 90 in place.
An annuloplasty implant 50 is attached to the second support ring 44 of the implantation instrument 40, by means of sutures 51 or clips. The annuloplasty implant 50 may be any type of annuloplasty ring, such as the CG FutureTM Annuloplasty System manufactured by Medtronic, Inc., the SJM Tailor® Annuloplasty Ring or the SJM Tailor® Flexible Annuloplasty Band manufactured by St. Jude Medical, Inc., the SoveringTM manufactured by Sorin Group, the Carpentier-McCarthy-Adams IMR ETlogix Annuloplasty Ring® or the Carpentier-Edwards Classic Annuloplasty Ring® manufactured by Edwards Lifesciences Corporation, which annuloplasty ring may form a complete ring-shape or an arcuate shape. The annuloplasty implant 50 is adapted to be attached to the valve annulus 20 by means of suture threads, as will be explained in further detail below. The annuloplasty implant 50 has a shape conforming to a desired shape of the valve annulus 20. Thus, when attached to the valve annulus 20, the annuloplasty implant 50 will reshape the valve annulus 20 to a desired shape. The annuloplasty implant 50 is non-stretchable lengthwise, which implies that when attached to the valve annulus it will not allow dilatation of the annulus. However, the annuloplasty implant may be flexible to change its shape while maintaining its length to allow the normal movements of the valve annulus 20 during a heart cycle. The annuloplasty implant 50 may have sections of differing rigidity and flexibility to comply with the normal movements of the valve annulus 20 during the heart cycle.
Referring now to FIGS 4–7, a method for repairing a heart valve by means of the device will be described. First, access to the heart valve is achieved by conventional techniques, including arresting the heart and opening the chest. In FIG. 4A, the device is shown when being inserted to the mitral valve 18. The implantation instrument 40 connected to a carrier 52, which has an arcuate portion 53 integral with the second support ring 44 and a stem 55 coupled with the arcuate portion 53, for remote control of the positioning of the carrier 52 and implantation instrument 40. An end of the first support ring 42 is brought to a corner of the opening between the leaflets 22, 24 of the mitral valve 20, as shown in FIG. 4B. The end is led through the opening and the carrier 52 is turned 360 degrees. Thus, the first support ring 42 will be rotated into place on one side of the valve 18, whereas the second support ring 44 is placed on the opposite side of the valve 18. In this way, the implantation instrument 40 is arranged in engagement with the valve 18, as shown in FIG. 5.
The leaflets 22, 24 may now be drawn towards each other through the pinch of the support rings 42, 44, as illustrated in FIG. 6. The leaflets are drawn through the pinch by means of a forceps instrument 54. The support rings 42, 44 may flex away from each other to allow drawing leaflets 22, 24 through the pinch and towards each other for preventing the leaflets 22, 24 to slip back. The valve annulus 20 may in this way be reshaped and be temporarily held in the new shape by means of the implantation instrument 40. The support rings 42, 44 may have roughened, opposed surfaces 46 to better keep the leaflets 22, 24 from slipping through the pinch and to hold the valve annulus 20 in its reshaped form.
The annuloplasty implant 50, which has been carried into position by means of the second support ring 44, may now be attached to the valve annulus 20 for achieving a permanent reshaping of the annlus 20. Since a primary reshaping has already been made, the positioning of the annuloplasty implant 50 is facilitated. The annuloplasty implant 50 is sutured to the valve annulus, as illustrated in FIG. 7, showing a completed suture 60 attaching the annuloplasty implant 50 to the valve annulus 20 and showing a suture 62 being performed. In this way, the annuloplasty implant 50 is firmly attached to the valve annulus 20 for keeping the valve annulus 20 in its reshaped form. The leaflets 22, 24 may also or alternatively be drawn towards each other through the pinch of the support rings 42, 44 during suturing of the annuloplasty implant 50.
When the annuloplasty implant 50 has been firmly attached to the valve annulus 20, the annuloplasty implant 50 is released from the implantation instrument 40. The sutures 51 holding the annuloplasty implant 50 attached to the second support ring 44 are cut in order to release the annuloplasty implant 50 from the implantation instrument 40. Now, the implantation instrument 40 may be withdrawn. The carrier 52 is turned 360 degrees in order to rotate the first support ring 42 to be retracted through the opening between the leaflets 22,24. Thereafter, the carrier 52 with the implantation instrument 40 may be retracted from the patient. As shown in FIG. 8, the annuloplasty implant 50 is now left in the patient holding the valve annulus 20 in a reshaped form such as to function normally.
As an alternative, the implantation instrument 40 does not carry the annuloplasty implant 50. In this case, the implantation instrument 40 is inserted into position first. This positioning of the implantation instrument 40 may be performed as described above with reference to FIGS. 4–6. While the implantation instrument 40 is held in place maintaining the temporary reshaping of the valve annulus 20, the annuloplasty implant 50 may be inserted to the mitral valve by means of conventional techniques for inserting an annuloplasty ring using a carrier. The annuloplasty implant 50 is then sutured to the valve annulus in order to permanently keep the valve annulus 20 in its reshaped form. Thereafter, the carrier used for inserting the annuloplasty implant 50 and the implantation instrument 40 may be withdrawn leaving the annuloplasty implant 50 in the patient.
It should be emphasized that the preferred embodiments described herein are in no way limiting and that many alternative embodiments are possible within the scope of protection defined by the appended claims.
For example, the access to the heart valve may be achieved endoscopically. In such case, the implantation instrument 40 and the annuloplasty implant 50 need to be inserted through a narrow tube (endoscope). This implies that the implantation instrument 40 and the annuloplasty implant 50 will need to be compressed during insertion in order to pass through the endoscope. The implantation instrument 40 needs to assume its proper shape after having been passed through the endoscope. Therefore, using an endoscopic approach, the implantation instrument 40 should preferably be formed from a shape memory material. This allows the implantation instrument 40 to be compressed and also to have a stable shape when being applied to the heart valve. Further, the annuloplasty implant 50 needs to be flexible in order to be compressed for the insertion through the endoscope.

## Claims

1. A device for repairing a heart valve comprised of valve tissue including an annulus and a plurality of leaflets for allowing and preventing blood flow, the device comprising:
an implantation instrument, comprising:
a first support ring, and
a second support ring connected to said first support ring to form a coiled configuration, said first support ring configured to abut one side of the valve and said second support ring configured to abut an opposite side of the valve to thereby trap a portion of the valve tissue therebetween, and an annuloplasty implant adapted to be attached to the heart valve annulus in order to reshape the annulus and allow the leaflets to open and close properly, said annuloplasty implant being connected to the implantation instrument for insertion to the annulus, wherein the annuloplasty implant is removably attached to the second support ring of the implantation instrument such that the implantation instrument may be withdrawn from a patient after the annuloplasty implant has been attached to the heart valve annulus.

2. The device according to claim 1, wherein said first and second support rings have generally triangular-shaped cross sections.

3. The device according to claim 1, wherein said first and second support rings are formed from a shape memory alloy.

4. The device according to claim 1, wherein the implantation instrument further comprises a material on at least one of said first and second support rings for reducing friction between the respective rings and the valve tissue in the longitudinal direction of the rings.

5. The device according to claim 1, wherein opposed surfaces of said first and second support rings are roughened to facilitate engagement with the valve tissue.

6. The device according to claim 5, further comprising a coating of cushioning material on each of said opposite surfaces.

7. The device according to claim 1, wherein each of said first and second support rings is formed from a fabric material.

8. The device according to claim 1, further comprising a stem, which is connected to the implantation instrument for carrying said first and second support rings into position on opposite sides of the valve.

9. The device according to claim 1, wherein said first and second support rings are adjustable in diameter to allow adjustment of the valve annulus.

10. The device according to claim 1, wherein the annuloplasty implant has a desired arcuate shape conforming to an arcuate shape of a portion of the annulus.

11. The device according to claim 1, wherein the annuloplasty implant has a ring-shape conforming to the desired shape of the annulus.

12. The device according to claim 1, wherein the annuloplasty implant is attached to the second support ring by means of a removable suture.

13. The device according to claim 1, wherein the annuloplasty implant is arranged to be attached to the annulus by means of suture threads.

14. A kit for repairing a heart valve comprised of valve tissue including an annulus and a plurality of leaflets for allowing and preventing blood flow, the kit comprising:
an implantation instrument, comprising:
a first support ring, and
a second support ring connected to said first support ring to form a coiled configuration, said first support ring configured to abut one side of the valve and said second support ring configured to abut an opposite side of the valve to thereby trap a portion of the valve tissue therebetween, and
an annuloplasty implant adapted to be attached to the heart valve annulus in order to reshape the annulus and allow the leaflets to open and close properly,
wherein the implantation instrument is adapted to temporarily reshape the heart valve annulus for allowing the annuloplasty implant to be attached to the heart valve annulus and the implantation instrument is adapted to be withdrawn from a patient after the annuloplasty implant has been attached to the heart valve annulus.

15. A method for repairing a heart valve comprised of valve tissue including an annulus and a plurality of leaflets for allowing and preventing blood flow, said method comprising:
inserting an implantation instrument comprising a first and a second support ring connected to each other to form a coiled configuration, said instrument being inserted such that valve tissue is trapped between the first and second support rings,
attaching an annuloplasty implant to the annulus in order to reshape it, and
removing the implantation instrument.

16. The method according to claim 15, wherein the step of inserting the instrument comprises temporarily reshaping the annulus to facilitate attachment of the annuloplasty implant to the annulus.

17. The method according to claim 15, wherein the step of inserting comprises
inserting a first end of the first support ring through a portion of the valve tissue,
rotating the implantation instrument to position the first support ring on a first side of the valve, and
positioning the second support ring on an opposite second side of the valve.