# US 2013/0158587 A1 · Apparatus and method for forming pilot holes in bone and delivering fasteners therein for retaining an implant

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- Number: US 2013/0158587 A1
- Document ID: US20130158587A1
- Status: Published application
- Kind: A1
- Application number: 13/717,474
- Filed: 2012-12-17
- Published: 2013-06-20
- Earliest claimed: 2011-12-19
- Assignees: Rotation Medical, Inc.
- Inventors: Charles L. EUTENEUER; Thomas A. WESTLING; Nathaniel Z. ZENZ-OLSON; Michael WITZMANN
- Web page: https://patentgrep.com/patent/US20130158587A1

## CPC

- A61F 2/0811: {Fixation devices for tendons or ligaments}
- A61B 17/0642: {for bones, e.g. for osteosynthesis or connecting tendon to bone}
- 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 17/0682: {for applying U-shaped staples or clamps, e.g. without a forming anvil}
- A61B 17/3472: {for bones, e.g. intraosseus injections}
- A61B 17/56: Surgical instruments or methods for treatment of bones or joints; Devices specially adapted therefor
- A61B 17/88: {Osteosynthesis instruments;} Methods or means for implanting or extracting internal {or external} fixation devices {(A61B17/7074 takes precedence)}
- A61B 17/8872: {Instruments for putting said fixation devices against or away from the bone (A61B17/7074, A61B17/808 take precedence)}
- A61B 17/1604: {Chisels; Rongeurs; Punches; Stamps}
- A61B 17/3468: {for implanting or removing devices, e.g. prostheses, implants, seeds, wires (devices for implanting seeds A61M37/0069)}
- A61B 2017/3454: {Details of tips}
- A61B 2017/3488: {Fixation to inner organ or inner body tissue}
- A61B 2017/564: {Methods for bone or joint treatment}
- 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

Apparatus and methods for forming pilot holes in bone and deploying a staple therein for fixing a sheet-like implant to the bone. A pilot hole forming trocar assembly including a trocar and a position retention sleeve can be included. The trocar can be releasably coupled to the position retention sleeve and slide in keyed arrangement within the sleeve when uncoupled. The trocar can include a distal portion having a retractable blade and a pair of pilot hole forming spikes extending distally from the trocar shaft. Once the pilot holes are formed, the position retention sleeve maintains the position relative to the pilot holes while the trocar is removed and a staple delivery device can be inserted in the lumen of the position retention sleeve to deploy a staple in the pilot holes.

## Claims

### Claim 1

A pilot hole forming trocar assembly comprising:
a position retention sleeve having a lumen extending therethrough and at least one position retention member proximate a distal end of the position retention sleeve, the position retention member being configured to engage bone; and,
a trocar sized for being releasably disposed within the lumen of the position retention sleeve including at least one distally extending spike, wherein when assembled for use the at least one distally extending spike extends beyond the distal end of the position retention sleeve to form a pilot hole when contacted with bone.

### Claim 2 (depends on 1)

The pilot hole forming trocar assembly of claim 1, further comprising a collar for releasably coupling the trocar to the position retention sleeve.

### Claim 3 (depends on 1)

The pilot hole forming trocar assembly of claim 1, wherein the trocar further comprises a proximal knob portion having a surfacing for pounding the at least one spike into bone.

### Claim 4 (depends on 1)

The pilot hole forming trocar assembly of claim 1, wherein the trocar further comprises a retractable blade disposed at a distal end thereof.

### Claim 5 (depends on 1)

The pilot hole forming trocar assembly of claim 1 wherein the at least one position retention member comprises a semi-cylindrical member defining a longitudinal channel over the length thereof that is sized to allow the at least one spike of the trocar to be disposed in the channel during use.

### Claim 6 (depends on 5)

The pilot hole forming trocar assembly of claim 5, wherein two spikes and two position retention members are included to form pilot holes and retain position to allow inserting a staple having a bridge and two arms into formed pilot holes.

### Claim 7 (depends on 1)

The pilot hole forming trocar assembly of claim 1, wherein the position retention member is a barbed projection.

### Claim 8 (depends on 1)

The pilot hole forming trocar assembly of claim 1, wherein the at least one spike has a distally tapering cross section.

### Claim 9 (depends on 1)

The pilot hole forming trocar assembly of claim 1, further comprising a viewing window proximate a distal end of the position retention member.

### Claim 10

A kit for deploying a staple in bone for fixing a sheet-like implant in position on a tendon, the kit comprising:
a position retention sleeve having a lumen extending therethrough and at least one position retention member proximate a distal end of the position retention sleeve;
a trocar sized for being releasably disposed within the lumen of the position retention sleeve, the trocar including at least one distally extending spike, wherein when assembled for use the at least one distally extending spike extends beyond the distal end of the position retention sleeve to form a pilot hole when contacted with bone; and,
a staple delivery device having a barrel sized for disposition within the lumen of the position retention sleeve and delivery of a staple from a distal portion thereof, wherein the barrel is keyed for controlled rotational position of the barrel relative to the position retention sleeve.

### Claim 11 (depends on 10)

The kit of claim 10, further comprising a collar for releasably coupling the trocar to the position retention sleeve.

### Claim 12 (depends on 10)

The kit of claim 10, wherein the trocar further comprises a proximal knob portion having a surfacing for pounding the at least one spike into bone.

### Claim 13 (depends on 10)

The kit of claim 10, wherein the trocar further comprises a retractable blade disposed at a distal end thereof.

### Claim 14 (depends on 10)

The kit of claim 10 wherein the at least one position retention member comprises a semi-cylindrical member defining a longitudinal channel over the length thereof that is sized to allow the at least one spike of the trocar to be disposed in the channel during use.

### Claim 15 (depends on 14)

The kit of claim 14, wherein two spikes and two position retention members are included to form pilot holes and retain position to allow inserting a staple having a bridge and two arms into formed pilot holes.

### Claim 16 (depends on 10)

The kit of claim 10, wherein the position retention member is a barbed projection.

### Claim 17 (depends on 10)

The kit of claim 10, wherein the at least one spike has a distally tapering cross section.

### Claim 18 (depends on 10)

The kit of claim 10, further comprising a viewing window proximate a distal end of the position retention member.

### Claim 19

A method for fixing a positioned sheet-like material to bone comprising the steps of:
providing a position retention sleeve having a lumen extending therethrough and at least one position retention member proximate a distal end of the position retention sleeve;
providing a trocar sized for being releasably disposed within the lumen of the position retention sleeve, the trocar including at least one distally extending spike;
positioning the trocar within the position retention sleeve with the at least one spike extending beyond the distal end of the position retention sleeve;
driving the spike into bone to form at least one pilot hole;
removing the trocar with the position retention member maintaining the sleeve position relative to the at least one formed pilot hole;
providing a staple delivery device having a barrel sized for disposition within the lumen of the position retention sleeve wherein the barrel is keyed for controlled rotational position of the barrel relative to the position retention sleeve; and,
inserting the staple delivery barrel into the sleeve lumen and deploying a staple.

### Claim 20 (depends on 19)

The method of claim 19, further comprising using the distal end of the at least one spike to reposition at least a portion of the sheet-like material.
