# US 8,771,292 B2 · Minimally invasive mitral valve repair method and apparatus

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- Number: US 8,771,292 B2
- Document ID: US8771292B2
- Status: Granted
- Kind: B2
- Application number: 13/752,167
- Filed: 2013-01-28
- Published: 2013-05-30
- Granted: 2014-07-08
- Earliest claimed: 1999-10-21
- Assignees: Edwards Lifesciences Corporation
- Applicants: Edwards Lifesciences Corporation
- Inventors: William J. Allen; Alan B. Bachman; Scott Reed; Leland R. Adams; Robert R. Steckel
- Web page: https://patentgrep.com/patent/US8771292B2

## CPC

- A61B 17/062: Needle manipulators
- 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)}
- A61B 17/0469: {Suturing instruments for use in minimally invasive surgery, e.g. endoscopic surgery}
- A61B 17/0482: {Needle or suture guides (guides for drills, pins or wire A61B17/17; guides for puncturing needles A61B17/3403)}
- A61B 17/064: Surgical staples, {i.e. penetrating the tissue}
- A61B 17/068: Surgical staplers {, e.g. containing multiple staples or clamps}({staplers containing only one staple A61B17/10; magazines or containers for staples A61B17/105;} for performing anastomosis A61B17/115; {staplers in general B25C5/00})
- A61B 17/122: Clamps or clips, e.g. for the umbilical cord {(for the vas deferens A61F6/206)}
- A61B 17/1227: {Spring clips}
- A61B 2017/00243: {cardiac}
- A61B 2017/00783: {Valvuloplasty}
- A61B 2017/0417: {T-fasteners}
- A61B 2017/0458: {Longitudinal through hole, e.g. suture blocked by a distal suture knot}
- A61B 2017/0464: {for soft tissue}
- A61B 2017/047: {having at least one proximally pointing needle located at the distal end of the instrument, e.g. for suturing trocar puncture wounds starting from inside the body}
- A61B 2017/0472: {Multiple-needled, e.g. double-needled, instruments}
- A61B 2017/06057: {Double-armed sutures, i.e. sutures having a needle attached to each end}
- A61B 2017/0641: {having at least three legs as part of one single body}
- A61B 2017/306: {holding by means of suction}
- A61F 2/246: {Devices for obstructing a leak through a native valve in a closed condition}
- A61B: DIAGNOSIS; SURGERY; IDENTIFICATION (usefulness limited to only animals A61D)
- A61F: FILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS (dental prosthetics A61C)

## Abstract

The present invention is directed to an apparatus and method for the stabilization and fastening of two pieces of tissue. A single device may be used to both stabilize and fasten the two pieces of tissue, or a separate stabilizing device may be used in conjunction with a fastening device. After the pieces of tissue are stabilized, they are fastened together using sutures or clips. One exemplary embodiment of a suture-based fastener comprises a needle connected to a suture. The needle enters the blind side of the tissue and exits the front side. The suture is then tied in a knot to secure the pieces of tissue. One example of a clip-based fastener comprises a spring-loaded clip having two arms with tapered distal ends and barbs. The probe includes a deployment mechanism which causes the clip to pierce and lockingly secure the two pieces of tissue.

## Claims

### Claim 1

An apparatus for treating tissue within a patient's body, the apparatus comprising:
a generally elongated catheter having a distal end portion and a proximal end portion;
a vacuum port assembly positioned on the catheter distal end portion, the vacuum port assembly configured to apply a vacuum in order to releasably grasp tissue;
a vacuum control apparatus configured to control the application of vacuum to the vacuum port assembly;
an extension member configured to extend and retract from the distal end portion of the generally elongated catheter;
a first suture needle configured to deploy suture through tissue, the first suture needle secured to a first suture end and positioned on the extension member with a first needle tip directed substantially proximally, wherein the first suture needle is configured to be proximally moved tip-first toward the catheter distal end portion;
a second suture needle configured to deploy suture through tissue, the second suture needle secured to a second suture end and positioned on the extension member with a second needle tip direct substantially proximally, wherein the second suture needle is configured to be proximally moved tip-first toward the catheter distal end portion;
a needle capturing apparatus configured to grip and retain the first suture needle and the second suture needle, wherein the needle capturing apparatus is positioned at the catheter distal end.

### Claim 2 (depends on 1)

The apparatus of claim 1, wherein the needle capturing apparatus comprises a first needle catch configured to grip and retain the first suture needle, and a second needle catch configured to grip and retain the second suture needle.

### Claim 3 (depends on 1)

The apparatus of claim 1, wherein the first suture end and the second suture end are opposing ends of a common suture line.

### Claim 4 (depends on 1)

The apparatus of claim 1, further comprising:
a suture needle actuator apparatus configured to independently actuate the first suture needle and the second suture needle, wherein the first suture needle can be actuated to deploy suture without actuation of the second suture needle.

### Claim 5 (depends on 4)

The apparatus of claim 4, wherein the vacuum port assembly comprises a first vacuum port on a first side of the catheter, and the vacuum control assembly is configured to provide vacuum to the first side of the catheter without simultaneously providing vacuum to a second side of the catheter.

### Claim 6 (depends on 5)

The apparatus of claim 5, wherein the suture deployment actuator apparatus is configured to selectively advance the first needle into the first vacuum port.

### Claim 7 (depends on 6)

The apparatus of claim 6, wherein the vacuum port assembly comprises a second vacuum port on a second side of the catheter, and wherein the suture deployment actuator apparatus is configured to selectively advance the second needle into the second vacuum port.

### Claim 8

An apparatus for treating tissue within a patient's body, the apparatus comprising:
a generally elongated catheter having a distal end portion and a proximal end portion;
a tissue grasping apparatus configured to grasp and release tissue, the tissue grasping apparatus positioned on the distal end portion of the catheter;
an extension member configured to extend and retract from the distal end portion of the generally elongated catheter;
a tissue fastening apparatus comprising a first tissue needle having a first needle tip and a second tissue needle having a second needle tip, wherein the first tissue needle and the second tissue needle are positioned on the extension member of the catheter with the first needle tip and the second needle tip directly substantially proximally;
a tissue grasping apparatus controller configured to actuate the tissue grasping apparatus to grasp tissue independently of deployment of the tissue fastening apparatus;
a needle capturing apparatus configured to grip and retain the first suture needle and the second suture needle, wherein the needle capturing apparatus is positioned at the catheter distal end;
and a tissue fastening apparatus actuator configured to advance the first needle tip and the second needle tip into the needle capturing apparatus.

### Claim 9 (depends on 8)

The apparatus of claim 8, wherein the tissue grasping apparatus comprises a vacuum port positioned on a first side of the catheter and the catheter is configured to provide vacuum to the first side of the catheter without simultaneously providing vacuum to a second side of the catheter.

### Claim 10 (depends on 8)

The apparatus of claim 8, wherein the tissue grasping apparatus comprises a vacuum port assembly comprising a first vacuum port and a second vacuum port, and the tissue grasping apparatus controller comprises a vacuum controller configured to selectively provide vacuum to the first vacuum port without simultaneously providing vacuum to the second vacuum port.

### Claim 11 (depends on 10)

The apparatus of claim 10, wherein the vacuum controller is further configured to selectively provide vacuum to the second vacuum port without simultaneously providing vacuum to the first vacuum port.

### Claim 12 (depends on 10)

The apparatus of claim 10, wherein the vacuum controller is further configured to selectively provide vacuum simultaneously to the second vacuum port and the first vacuum port.

### Claim 13 (depends on 8)

The apparatus of claim 8, wherein the needle capturing apparatus comprises a first needle catch configured to grip and retain the first suture needle, and a second needle catch configured to grip and retain the second suture needle.

### Claim 14 (depends on 13)

The apparatus of claim 13, wherein the tissue grasping apparatus comprises a vacuum port assembly comprising a first vacuum port and a second vacuum port, and wherein the first needle catch is positioned within the first vacuum port and the second needle catch is positioned within the second vacuum port.

### Claim 15 (depends on 8)

The apparatus of claim 8, wherein the first suture end and the second suture end are opposing ends of a common suture line.

### Claim 16

An apparatus for treating tissue within a patient's body, comprising:
a generally elongated catheter comprising a proximal end and a distal end;
an extension member configured to extend and retract from the distal end of the generally elongated catheter;
a tissue fastening apparatus comprising a first tissue needle having a first needle tip and a second tissue needle having a second needle tip, wherein the first tissue needle and the second tissue needle are positioned on the extension member of the catheter with the first needle tip and the second needle tip directly substantially proximally;
a needle capturing apparatus configured to grip and retain the first suture needle and the second suture needle, wherein the needle capturing apparatus is positioned at the catheter distal end; and
a tissue fastening apparatus actuator configured to advance the first needle tip and the second needle tip into the needle capturing apparatus, wherein the tissue fastening apparatus actuator is configured to independently control advancement of the first needle tip and the second needle tip.

### Claim 17 (depends on 16)

The apparatus of claim 16, wherein the tissue fastener apparatus further comprise a length of suture material, and the first and second needles are connected to opposite ends of the suture material.

### Claim 18 (depends on 16)

The apparatus of claim 16, wherein the extension member comprises a first extension portion and a second extension portion, wherein the first needle is releasably secured to the first extension portion and the second needle is releasably secured to the second extension portion, wherein the first extension portion and the second extension portion are configured to be independently advanced and retracted from the catheter distal end.

### Claim 19 (depends on 16)

The apparatus of claim 16, wherein the needle capturing apparatus comprises a first capturing portion and a second capturing portion, wherein the first capturing portion is configured to capture the first needle tip and the second capturing portion is configured to capture the second needle tip, wherein the first capturing portion and the second capturing portion are configured to be independently advanced and retracted from the catheter distal end.

### Claim 20 (depends on 18)

The apparatus of claim 18, wherein the needle capturing apparatus comprises a first capturing portion and a second capturing portion, wherein the first capturing portion is configured to capture the first needle tip and the second capturing portion is configured to capture the second needle tip, wherein the first capturing portion and the second capturing portion are configured to be independently advanced and retracted from the catheter distal end;
wherein the first extension portion and the first capturing portion are on a first side of the extension member, and the second extension portion and the second capturing portion are on a second side of the extension member, wherein the first side and the second side are opposing sides of the extension member.
