# US 9,750,608 B2 · Systems and methods for introducing elements into tissue

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- Number: US 9,750,608 B2
- Document ID: US9750608B2
- Status: Granted
- Kind: B2
- Application number: 14/462,177
- Filed: 2014-08-18
- Published: 2015-02-19
- Granted: 2017-09-05
- Earliest claimed: 2007-03-13
- Assignees: Mitralign, Inc.
- Applicants: Mitralign, Inc.
- Inventors: Paul A. Spence; Donald S. Baim; Edward I. McNamara; Hiroatsu Sugimoto; Joseph P. Lane; Christopher Lee; Jason H. Robinson; Aaron M. Call; Richard J. Morrill
- Web page: https://patentgrep.com/patent/US9750608B2

## CPC

- A61F 2/2466: {Delivery devices therefor}
- A61B 17/00234: {for minimally invasive surgery (A61B17/0218, A61B17/0469, A61B17/12013, A61B17/1285, A61B17/29, A61B17/320016 take precedence)}
- A61B 17/0057: {Implements for plugging an opening in the wall of a hollow or tubular organ, e.g. for sealing a vessel puncture or closing a cardiac septal defect (sutures A61B17/04; closing rectum or urethra near body surface A61F2/0009)}
- 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 17/0487: {Suture clamps, clips or locks, e.g. for replacing suture knots; Instruments for applying or removing suture clamps, clips or locks (suture anchors A61B17/0401; wound clamps or clips A61B17/08; ligaturing clamps or clips A61B17/122)}
- A61B 17/06166: {Sutures (suture materials A61L17/00; manufacture of artificial threads D01D; treatment of threads D06M)}
- A61F 2/2427: {Devices for manipulating or deploying heart valves during implantation}
- A61F 2/2442: {Annuloplasty rings or inserts for correcting the valve shape; Implants for improving the function of a native heart valve}
- A61F 2/2445: {Annuloplasty rings in direct contact with the valve annulus}
- A61B 17/0467: {Instruments for cutting sutures (surgical cutting instruments A61B17/32)}
- A61B 90/39: {Markers, e.g. radio-opaque or breast lesions markers}
- A61B 2017/00243: {cardiac}
- A61B 2017/00637: {for sealing trocar wounds through abdominal wall}
- A61B 2017/00659: {located only on one side of the opening}
- A61B 2017/0411: {Instruments for removing suture anchors}
- A61B 2017/0417: {T-fasteners}
- A61B 2017/0419: {H-fasteners}
- A61B 2017/0464: {for soft tissue}
- A61B 2017/048: {for reducing heart wall tension, e.g. sutures with a pad on each extremity}
- A61B 2017/0488: {Instruments for applying suture clamps, clips or locks}
- A61B 2017/0496: {for tensioning sutures}
- A61B 2017/0619: {thermoplastic, e.g. for bonding, welding, fusing or cutting the suture by melting it}
- A61B 2090/0811: {for the position of a particular part of an instrument with respect to the rest of the instrument, e.g. position of the anvil of a stapling instrument}
- A61B 2090/3966: {Radiopaque markers visible in an X-ray image}
- 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)
- A61B: DIAGNOSIS; SURGERY; IDENTIFICATION (usefulness limited to only animals A61D)

## Abstract

A system is provided for delivering respective anchors into spaced apart locations along an annulus of a mitral valve. The system includes a first catheter member having a first lumen formed therein for receiving a first guide wire and also includes a second catheter member that is configured to move between an expanded position and a collapsed position relative to the first catheter member. The second catheter member has a lumen formed therein for receiving a second guide wire when the second catheter member is in the expanded position. The second catheter member is fixedly connected to the first catheter member by a first connector (that defines first and second living hinges) which is configured to deploy under a select condition to automatically cause the second catheter member to move to the expanded position.

## Claims

### Claim 1

A system for delivering respective anchors into spaced apart locations along an annulus of a mitral valve comprising:
a first catheter member having a first lumen formed therein for receiving a first guide wire so as to permit the first catheter member to move along the first guide wire; and
a second catheter member that is configured to move between an expanded position and a collapsed position relative to the first catheter member, the second catheter member having a second lumen formed therein for receiving a second guide wire when the second catheter member is in the expanded position, wherein the second catheter member is fixedly connected to the first catheter member by a first connector which is configured to deploy under a select condition to automatically cause the second catheter member to move to the expanded position, the first connector defining a first living hinge adjacent to a location at which the first connector is attached about an exterior of the first catheter member and a second living hinge adjacent to a location at which the first connector is attached about an exterior of the second catheter member;
wherein the first connector comprises a first connecting bar that is configured to provide a biasing force to the second catheter member when the select condition occurs, thereby causing the second catheter member to move to the expanded position, the first connector further including: (a) a first coupling member that is coupled about the exterior of the first catheter member with a first portion of the first connecting bar being captured between the exterior of the first catheter member and the first coupling member and (b) a second coupling member that is coupled about the exterior of the second catheter member with a second portion of the first connecting bar being captured between the exterior of the second catheter member and the second coupling member.

### Claim 2 (depends on 1)

The system of claim 1, wherein the first and second catheter members comprise elongated structures with the first and second lumens, respectively, being formed centrally therein.

### Claim 3 (depends on 1)

The system of claim 1, further including a third catheter member that moves between an expanded position and a collapsed position relative to the first catheter member, the third catheter member having a third lumen formed therein for receiving a third guide wire when the third catheter member is in the expanded position, wherein the third catheter member is fixedly connected to the first catheter member by a second connector which is configured to deploy under a select condition to automatically cause the third catheter member to move to the expanded position.

### Claim 4 (depends on 3)

The system of claim 3, wherein the second catheter member is disposed along a first side of the first catheter member and the third catheter member is disposed along a second side of the first catheter member which is opposite the first side.

### Claim 5 (depends on 3)

The system of claim 3, wherein the second connector comprises a second connecting bar that is configured to provide a biasing force to the third catheter member when the select condition occurs, thereby causing the third catheter member to move to the expanded position.

### Claim 6 (depends on 5)

The system of claim 5, wherein the second connecting bar comprises a third plate stacked against a fourth plate, the third plate having an elastic property to provide the biasing force and the fourth plate is configured to provide support.

### Claim 7 (depends on 6)

The system of claim 6, wherein the third plate is formed of a material that provides a spring force and the fourth plate comprises a metal plate.

### Claim 8 (depends on 5)

The system of claim 5, wherein the second connecting bar is configured to cause the third catheter member to translate distally and also expand laterally outward to the expanded position.

### Claim 9 (depends on 1)

The system of claim 1, wherein the first connecting bar is configured to cause the second catheter member to translate distally and also expand laterally outward to the expanded position.

### Claim 10 (depends on 1)

The system of claim 1, further including an outer sheath that has an inner lumen for receiving and containing at least first portions of the first and second catheter members, wherein the first and second catheter members are slidably movable within the inner lumen of the outer sheath to permit distal end portions of the first and second catheter members to be advanced distally beyond an open distal end of the outer sheath.

### Claim 11 (depends on 10)

The system of claim 10, wherein the second catheter is configured to be disposed distally beyond the opening end of the outer sheath under the select condition to allow the second catheter member to automatically move to the expanded position.

### Claim 12 (depends on 1)

The system of claim 1, wherein the first connecting bar comprises a nickel-titanium alloy.

### Claim 13 (depends on 1)

The system of claim 1, wherein further including a second connector that is attached at one end to the first catheter member and at another end to the second catheter member, the first and second connectors being spaced from one another.

### Claim 14 (depends on 1)

The system of claim 1, further including a second connector comprising a second connecting bar extending between the first and second catheter and being configured to provide a biasing force to the second catheter member when the select condition occurs, thereby causing the second catheter member to move to the expanded position, the second connector further including: (a) a third coupling member that is coupled about the exterior of the first catheter member with a first portion of the second connecting bar being captured between the exterior of the first catheter member and the third coupling member and (b) a fourth coupling member that is coupled about the exterior of the second catheter member with a second portion of the second connecting bar being captured between the exterior of the second catheter member and the fourth coupling member; wherein the first and second connecting bars are spaced apart from one another with the second connector bar being closer to distal ends of the first and second catheter members.

### Claim 15

A system for delivering respective anchors into spaced apart locations along an annulus of a mitral valve comprising:
a first catheter member having a first lumen formed therein for receiving a first guide wire so as to permit the first catheter member to move along the first guide wire; and
a second catheter member that is configured to move between an expanded position and a collapsed position relative to the first catheter member, the second catheter member having a second lumen formed therein for receiving a second guide wire when the second catheter member is in the expanded position, wherein the second catheter member is fixedly connected to the first catheter member by a first connector which is configured to deploy under a select condition to automatically cause the second catheter member to move to the expanded position;
wherein the first connector comprises a first connecting bar that is configured to provide a biasing force to the second catheter member when the select condition occurs, thereby causing the second catheter member to move to the expanded position;
wherein the first connecting bar comprises a first plate stacked against a second plate, the first plate having an elastic property to provide the biasing force and the second plate is configured to provide support.

### Claim 16 (depends on 15)

The system of claim 15, wherein the first plate is formed of a material that provides a spring force and the second plate comprises a metal plate.

### Claim 17

A system for delivering respective anchors into spaced apart locations along an annulus of a mitral valve comprising:
a first catheter member having a first lumen formed therein for receiving a first guide wire so as to permit the first catheter member to move along the first guide wire; and
a second catheter member that is configured to move between an expanded position and a collapsed position relative to the first catheter member, the second catheter member having a second lumen formed therein for receiving a second guide wire when the second catheter member is in the expanded position, wherein the second catheter member is fixedly connected to the first catheter member by a first connecting bar which is configured to deploy under a select condition to automatically cause the second catheter member to move to the expanded position;
a third catheter member that moves between an expanded position and a collapsed position relative to the first catheter member, the third catheter member having a third lumen formed therein for receiving a third guide wire when the third catheter member is in the expanded position, wherein the third catheter member is fixedly connected to the first catheter member by a second connecting bar which is configured to deploy under a select condition to automatically cause the third catheter member to move to the expanded position; and
wherein first ends of the first and second connecting bars are connected to a common first connector that is secured to the first catheter member.

### Claim 18 (depends on 17)

The system of claim 17, wherein the first and second connecting bars comprise metal bars.

### Claim 19 (depends on 17)

The system of claim 17, wherein the first ends of the first and second connecting bars comprise living hinges.

### Claim 20 (depends on 17)

The system of claim 17, wherein further including a third connecting bar that is attached at one end to the first catheter member and at another end to the second catheter member and a fourth connecting bar that is attached at one end to the first catheter member and at another end to the third catheter member.
