# US 10,307,238 B2 · Method and devices for implantation of biologic constructs

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- Number: US 10,307,238 B2
- Document ID: US10307238B2
- Status: Granted
- Kind: B2
- Application number: 15/158,488
- Filed: 2016-05-18
- Published: 2016-09-15
- Granted: 2019-06-04
- Earliest claimed: 2010-04-15
- Assignees: Cannuflow, Inc.
- Applicants: Cannuflow, Inc.
- Inventors: Theodore R. Kucklick
- Web page: https://patentgrep.com/patent/US10307238B2

## CPC

- A61F 2/0063: {Implantable repair or support meshes, e.g. hernia meshes}
- A61B 17/3423: {Access ports, e.g. toroid shape introducers for instruments or hands (access sites for liquids A61M39/0247)}
- A61B 17/3462: {with means for changing the diameter or the orientation of the entrance port of the cannula, e.g. for use with different-sized instruments, reduction ports, adapter seals (expandable cannulas A61B17/3417)}
- A61M 39/0606: {without means for adjusting the seal opening or pressure (A61M39/0693 takes precedence)}
- A61B 17/0469: {Suturing instruments for use in minimally invasive surgery, e.g. endoscopic surgery}
- A61B 17/0483: {Hand-held instruments for holding sutures (A61B17/0469 takes precedence; other holders for needles or sutures A61B17/06061; surgical forceps A61B17/28; surgical pincettes A61B17/30)}
- A61B 17/06061: {Holders for needles or sutures, e.g. racks, stands (hand-held holding instruments A61B17/0483; holders for articles A61B50/20; racks for syringes or for hypodermic or infusion needles A61M5/008)}
- A61B 17/3468: {for implanting or removing devices, e.g. prostheses, implants, seeds, wires (devices for implanting seeds A61M37/0069)}
- A61F 2002/0072: {Delivery tools therefor}
- A61F 2210/0014: using shape memory or superelastic materials, e.g. nitinol
- 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)
- 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

Methods for delivering a sheet-like implant to a target site including a means of deploying and orienting the sheet-like implant within the body.

## Claims

### Claim 1

A method of delivering a sheet-like implant to a joint within the body of a patient, said method comprising:
creating an arthroscopic workspace around the joint and inserting a cannula through the skin of the patient proximate the arthroscopic workspace;
providing a sheet-like implant;
providing an implant holder assembly configured to hold the sheet-like implant, said implant holder assembly comprising a first leg and a second leg, a first slot disposed in a distal end of the first leg and a second slot disposed in a distal end of the second leg, said first leg and second leg movable between a closed and open position, wherein the first and second legs form an open-ended implant holder in the open position;
releasably attaching the sheet-like implant to the first slot and second slot of the implant holder assembly;
moving the first leg and second leg such that the implant holder assembly and implant fit, in a closed position, through the cannula;
inserting the implant holder assembly and implant, in the closed position, through the cannula and into the arthroscopic workspace;
moving the first leg and second leg in the open position within the workspace, wherein in the open position, the implant has a generally planar configuration that is substantially parallel to the first leg and second leg, and positioning the implant proximate an intended site of implantation;
releasing the implant from the implant holder assembly;
moving the first leg and second leg to the closed position and removing the implant holder assembly from the workspace; and
securing the implant to body tissue within the workspace.

### Claim 2 (depends on 1)

The method of claim 1 wherein the first leg and second leg comprise a superelastic material biased to the open position, such that the legs may be forced in apposition to each other to fit into the cannula and thereafter superelastically open upon exit from a distal end of the cannula.

### Claim 3 (depends on 1)

The method of claim 1 wherein the first leg and second leg comprise a resilient material biased to the open position, such that the legs may be forced in apposition to each other to fit into the cannula and thereafter resiliently open upon exit from a distal end of the cannula.

### Claim 4 (depends on 1)

The method of claim 1 wherein the joint is a shoulder.

### Claim 5

A method of delivering a sheet-like implant to a treatment site within the body of a patient, said method comprising:
creating a workspace around the treatment site and inserting a cannula through the skin of the patient proximate the workspace;
providing a sheet-like implant;
providing an implant delivery system, said implant delivery system comprising an elongate insertion portion, said implant delivery system further comprising a first leg and a second leg, said legs operably connected to hold the sheet-like implant, said legs pivotably attached to a distal end of the elongate insertion portion, said legs movable between a closed position and an open position, wherein the first and second legs form an open-ended implant holder in the open position, and wherein each leg is configured with a slot for grasping the implant;
moving the legs into a closed position with the sheet-like implant engaged such that the legs and implant fit, in the closed position, through the cannula;
inserting the legs and implant, in the closed position, through the cannula and into the workspace;
moving the legs and implant into the open position within the workspace, wherein in the open position, the implant has a generally planar configuration that is substantially parallel to the legs, and positioning the sheet proximate an intended site of implantation;
releasing the implant from the legs;
moving the legs into the closed position;
removing the implant delivery system from the workspace;
securing the implant to body tissue within the workspace.

### Claim 6 (depends on 5)

The method of claim 5 wherein the first leg and second leg comprise a superelastic material biased to the open position, such that the legs may be forced in apposition to each other to fit into the cannula and thereafter superelastically open upon exit from a distal end of the cannula.

### Claim 7 (depends on 5)

The method of claim 5 wherein the first leg and second leg comprise a resilient material biased to the open position, such that the legs may be forced in apposition to each other to fit into the cannula and thereafter resiliently open upon exit from a distal end of the cannula.

### Claim 8 (depends on 5)

The method of claim 5 wherein the joint is a shoulder.

### Claim 9

A method for delivering a sheet-like implant to a target site, the method comprising:
positioning a sheet-like implant retained on an implant delivery device proximate the target site, the implant delivery device comprising:
a delivery shaft having a proximal end, a distal end, and a longitudinal axis;
an implant holder assembly proximate the distal end of the delivery shaft, the implant holder assembly including a first leg and a second leg, the first leg and the second leg moveable between a closed position and an open position, a first slot disposed in the distal end of the first leg and a second slot disposed in the distal end of the second leg, wherein the first and second legs form an open-ended implant holder assembly in the open position;
wherein, in the closed position, distal ends of the first leg and the second leg are positioned at a first distance from the longitudinal axis;
wherein, in the open position, the distal ends of the first and second legs are positioned at a second distance from the longitudinal axis greater than the first distance with the sheet-like implant releasably attached to the first slot and second slot; and
wherein the distal ends of the first and second legs are configured to diverge away from one another as the first and second legs move from the closed position to the open position to spread the sheet-like implant into a planar configuration that is substantially parallel to the first and second legs;
moving the first leg and the second leg from the closed position to the open position to spread the sheet-like implant into the planar configuration; and
separating the sheet-like implant from the implant delivery device.

### Claim 10 (depends on 9)

The method of claim 9, further comprising attaching the sheet-like implant to the target site.

### Claim 11 (depends on 9)

The method of claim 9, further comprising moving the first leg and the second leg from the open position to the closed position and withdrawing the implant delivery device from the implant site.

### Claim 12 (depends on 9)

The method of claim 9 wherein the joint is a shoulder.