# US 9,750,493 B2 · Hand operated device for controlled deployment of a tissue anchor and method of using the same

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- Number: US 9,750,493 B2
- Document ID: US9750493B2
- Status: Granted
- Kind: B2
- Application number: 14/582,667
- Filed: 2014-12-24
- Published: 2015-05-14
- Granted: 2017-09-05
- Earliest claimed: 2010-10-27
- Assignees: Mitralign, Inc.
- Applicants: Mitralign, Inc.
- Inventors: Jason H. Robinson; Steven D. Cahalane; Megan E. Holmes; Christopher Lee; Michael W. Sutherland; Aaron M. Call; James M. Sellers; Michael R. Cole; Gregory J. Kenny; Mathew S. Cardinali
- Web page: https://patentgrep.com/patent/US9750493B2

## CPC

- 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 17/04: for suturing wounds; Holders or packages for needles or suture materials
- 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 17/2833: {Locking means}
- A61B 18/1492: {having a flexible, catheter-like structure, e.g. for heart ablation (A61B18/1477 takes precedence)}
- A61B 2017/00243: {cardiac}
- A61B 2017/003: {Steerable}
- A61B 2017/0046: {with a releasable handle; with handle and operating part separable}
- A61B 2017/00469: {for insertion of instruments, e.g. guide wire, optical fibre}
- A61B 2017/0406: {Pledgets}
- A61B 2017/0409: {Instruments for applying suture anchors}
- A61B 2017/0417: {T-fasteners}
- A61B 2017/0419: {H-fasteners}
- A61B 2017/0458: {Longitudinal through hole, e.g. suture blocked by a distal suture knot}
- A61B 2017/0464: {for soft tissue}
- A61B 2017/0475: {using sutures having a slip knot}
- A61B 2017/0477: {with pre-tied sutures}
- 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 2017/22038: {with a guide wire}
- A61B 2017/22074: {the instrument being only slidable in a channel, e.g. advancing optical fibre through a channel}
- A61B 2017/3447: {Linked multiple cannulas}
- A61B 2018/00357: {Endocardium}
- A61B 2018/00601: {Cutting}
- A61B 2018/144: {Wire}
- A61B 2090/3966: {Radiopaque markers visible in an X-ray image}
- A61F 2/2442: {Annuloplasty rings or inserts for correcting the valve shape; Implants for improving the function of a native heart valve}
- A61M 25/04: in the body, e.g. expansible {(A61M25/10, A61M16/0488 take precedence)}
- 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)
- A61M: DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY (introducing media into or onto the bodies of animals A61D7/00; means for inserting tampons A61F13/26; devices for administering food or medicines orally A61J; containers for collecting, storing or administering blood or medical fluids A61J1/05); DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY (surgery A61B; chemical aspects of surgical articles A61L); DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR {(Electrotherapy, e.g. producing anaesthesia by the use of alternating or intermittent currents A61N1/36021)}

## Abstract

A tissue anchoring system includes a tissue anchor member that is suitable for anchoring against tissue. The system also includes a tensioning member operatively connected to the anchor member such that the anchor member can slide relative to the tensioning member, the tensioning member capable of being pulled to cause the anchor member to move relative to the tensioning member into a position seated against the tissue. A hand operated deployment catheter is operable to extend and deploy the anchor member therefrom. The deployment catheter includes a rotatable member about which the tensioning member is routed and a clutch assembly for limiting tension within the tensioning member to prevent the deployed anchor from being pulled through the tissue.

## Claims

### Claim 1

A hand-held, hand operated tissue anchoring system for deploying
a tissue anchor:
an anchor member capable of being inserted through tissue and suitable for anchoring against at least one side of the tissue;
a tensioning member operatively connected to the anchor member such that the anchor member can slide relative to the tensioning member, the tensioning member capable of being pulled to cause the anchor member to move relative to said tensioning member to apply tension thereto to seat the anchor member;
a deployment catheter operable to extend and deploy the anchor member therefrom, the deployment catheter including:
a hand-held handle including a first housing body and a second housing body that is coupled to the first housing body so as to define a hollow interior therebetween;
a flexible catheter body that is fixedly attached to the handle at one end, the anchor member and connected tensioning member being contained within a main lumen of the catheter body;
a spool assembly contained within the hollow interior and including a spool about which the tensioning member is routed;
a slip clutch assembly that is contained within the hollow interior and is operatively coupled to the spool assembly, the slip clutch assembly being configured to limit tension within the tensioning member as the tensioning member is pulled and wound about the spool as tension is applied to the anchor member; and
a deployable pusher assembly, contained within the hollow interior, for controllably deploying a portion of the anchor member, the pusher assembly including a slideable pusher actuator that is coupled to and accessible along the handle and is moveable between a retracted position and an extended position in which the pusher assembly deploys at least a portion of the anchor member;
wherein the spool assembly further includes a spool ratchet that is separate from the spool and is configured to be at least partially received within a central opening of the spool, the spool ratchet including a lower toothed wheel that has teeth formed circumferentially along a peripheral edge of the wheel, the spool ratchet having an integral first clutch member that is flexible in a radial direction and is part of the clutch assembly and mates with a second clutch member that is part of the spool and is located along an inner surface thereof, wherein the spool ratchet and spool slip relative to one another when tension within the tensioning member exceeds a threshold value, thereby preventing the tensioning member from being overtensioned.

### Claim 2 (depends on 1)

The system of claim 1, wherein the anchor member is a flexible anchor member that is movable between an elongate configuration and a shortened configuration, the anchor member having a proximal end portion, a distal end portion and a compressible intermediate portion, wherein the shortened configuration comprises a zig-zag fold pattern and pulling of the tensioning member causes the anchor member to move from the elongate configuration to the shortened configuration, wherein the compressible intermediate portion can compress and thereby adjust to a thickness of the layer of the tissue between the proximal and distal end portions.

### Claim 3 (depends on 1)

The system of claim 1, wherein the anchor member is formed from a material selected from at least one of: natural fibers, synthetic fibers, polymers, and metals.

### Claim 4 (depends on 1)

The system of claim 1, wherein said tensioning member comprises a suture.

### Claim 5 (depends on 1)

The system of claim 1, wherein the tensioning member includes a stop member engageable with the anchor member.

### Claim 6 (depends on 5)

The system of claim 5, wherein said stop member further comprises a knot in the tensioning member.

### Claim 7 (depends on 1)

The system of claim 1, wherein the catheter body is a rapid exchange catheter body that includes a guide wire lumen for receiving a guide wire and a main lumen for receiving the anchor member and the tensioning member.

### Claim 8 (depends on 7)

The system of claim 7, wherein the guide wire lumen opens at a distal tip of the catheter body with the main lumen of the catheter body being open at a location that is spaced from and located proximal to the distal tip.

### Claim 9 (depends on 7)

The system of claim 7, wherein the pusher assembly includes a pivotable push pawl that is coupled to a housing of the handle and interlockingly engages the slideable pusher actuator such that free rearward movement of the pusher assembly is prevented.

### Claim 10 (depends on 9)

The system of claim 9, wherein the push pawl is coupled to a biasing member that is fixedly attached to the housing and the push pawl has an arm that has teeth that interlockingly engages teeth formed along a locking rail of the slideable pusher actuator.

### Claim 11 (depends on 9)

The system of claim 9, wherein the slideable pusher moves along a rail formed along an inner surface of the housing of the handle, with the rail including a first locking notch for locking the slideable pusher in the extended position and a second locking notch for locking the slideable pusher in the retracted position.

### Claim 12 (depends on 1)

The system of claim 1, wherein the spool assembly further includes a rotatable thumb wheel that is accessible along the handle and is coupled to the spool ratchet such that rotation of the thumb wheel is translated into rotation of the spool ratchet.

### Claim 13 (depends on 1)

The system of claim 1, wherein the first clutch member comprises at least one flexible arcuate shaped finger that extends along an arc of a center hub of the spool ratchet and includes a locking detent at a free end thereof and the second clutch member comprises a circumferential raised wall that is formed as part of the spool and includes a plurality of recessed sections that alternate with platform sections of the raised wall, wherein in a normal operating position, the locking detent is biased into and held within one of the recessed sections until the tension within the tension member exceeds the threshold value, whereby the locking detent slips out of engagement with the recessed section and rides along an adjacent platform section until being biased into the next recessed section.

### Claim 14 (depends on 13)

The system of claim 13, wherein there is an empty space formed between the center hub of the spool ratchet and an inner face of the flexible arcuate shaped finger, the flexible arcuate shaped finger being configured to flex inwardly into one respective empty space.

### Claim 15 (depends on 13)

The system of claim 13, wherein the locking detent comprises a free distal end of the flexible arcuate shaped finger that has increased thickness compared to a main portion of the flexible arcuate shaped finger.

### Claim 16 (depends on 1)

The system of claim 1, wherein the spool assembly further includes a button that is accessible along the handle and a spool lock that is pivotably coupled to a housing of the handle and is coupled to both the button and a biasing member, the spool lock including an arm that has a locking edge that includes a plurality of teeth, wherein movement of the button toward the spool causes pivoting the arm of the spool lock toward to the spool ratchet until the teeth of the spool lock interlockingly engage the teeth of the spool ratchet, thereby preventing free rotation of the ratchet wheel and spool.

### Claim 17 (depends on 1)

The system of claim 1, wherein the pusher assembly includes a pusher that is coupled to and movable with the slideable pusher actuator and has a pusher conduit fixedly attached and extending outwardly from one end thereof, the pusher conduit having a lumen that receives the tensioning member, and wherein the spool assembly includes a spool detent that is movable within a guide slot formed in a part that makes up a housing of the handle and includes a portion that has teeth, wherein when the slideable pusher actuator is in the retracted position, a portion of the pusher engages and drives the spool detent toward the spool assembly such that the teeth of the spool detent engage complementary teeth formed as part of the spool assembly and prevent the spool assembly from rotating.