Apparatus and method for forming pilot holes in bone and delivering fasteners therein for retaining an implant

Patent metadata

Field	Value
Publication number	US-10912640-B2
Application number	US-201816150894-A
Country	US
Kind code	B2
Filing date	Oct 3, 2018
Priority date	Dec 19, 2011
Publication date	Feb 9, 2021
Grant date	Feb 9, 2021

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.

First claim

What is claimed is:

1. A fastener delivery system, comprising:
a position retention sleeve having a proximal end, a distal end, and a lumen extending therethrough;
wherein the distal end of the position retention sleeve comprises a pair of position retention members fixed to and extending distally from the distal end of the position retention sleeve;
a pilot hole forming trocar removably disposed in the lumen of the position retention sleeve, the pilot hole forming trocar including two distally extending spikes extending distally beyond the pair of position retention members to form a pair of pilot holes in a bone; and
a fastener delivery device positionable in the lumen of the position retention sleeve;
wherein the fastener delivery device is configured to deliver a fastener into the pair of pilot holes formed by the trocar;
wherein the removable pilot hole forming trocar and the fastener delivery device are each configured and adapted to be releasably and slideably received within the lumen of the position retention sleeve.

2. The system of claim 1 , wherein the pair of position retention members comprise semi-cylindrical members each defining a longitudinal channel for receiving one of the spikes therealong.

3. The system of claim 1 , wherein the pair of position retention members are included on an insert affixed proximate the distal end of the position retention sleeve.

4. The system of claim 1 , wherein the pair of position retention members are integral with a tubular member defining the lumen of the position retention sleeve.

5. The system of claim 1 , wherein the pair of position retention members are configured and adapted to retain a position of the position retention sleeve when the pair of position retention members are inserted into the bone.

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

7. The system of claim 6 , wherein the retractable blade is positioned between the two distally extending spikes.

8. The system of claim 1 , wherein the two distally extending spikes of the removable pilot hole forming trocar each have a distally tapering cross-section.

9. The system of claim 1 , wherein the removable pilot hole forming trocar further comprises a collar which releasably couples the removable pilot hole forming trocar to the position retention sleeve.

10. The system of claim 1 , wherein the removable pilot hole forming trocar is removable from the position retention sleeve and replaceable by the fastener delivery device in the lumen of the position retention sleeve while retaining a position of the position retention sleeve with the pair of position retention members in the pilot holes.

11. The system of claim 10 , wherein the fastener delivery device comprises a pair of stakes which are received along the pair of position retention members and within the pilot holes when the fastener delivery device has replaced the removable pilot hole forming trocar within the lumen of the position retention sleeve.

12. The system of claim 11 , wherein the fastener delivery device further comprises a handle assembly connectable to the proximal end of the position retention sleeve, the handle assembly being operatively coupled to a mechanism which deploys a fastener in the pilot holes formed in the bone.

13. The system of claim 11 , wherein the fastener delivery device is configured to deliver a staple into the pilot holes within the bone.

14. The system of claim 13 , wherein the staple includes a pair of arms connected by a bridge with the pair of arms sized and configured to be advanced into the pilot holes.

15. A method of fixing a positioned sheet-like implant to a bone comprising the steps of:
positioning a sheet-like implant at a location adjacent to a bone;
positioning a distal end of a position retention sleeve having a lumen therethrough and containing a removable pilot hole forming trocar adjacent to the bone with the sheet-like implant interposed therebetween;
urging a pair of distally extending spikes of the removable pilot hole forming trocar through the sheet-like implant and into the bone to form pilot holes in the bone;
wherein urging the pair of distally extending spikes into the bone also extends a pair of position retention members fixed to a distal end of the position retention sleeve into the pilot holes in the bone;
removing the removable pilot hole forming trocar from the position retention sleeve while leaving the pair of position retention members in the pilot holes in the bone;
inserting a fastener delivery device having a fastener on a distal end thereof into the position retention sleeve after removing the removable pilot hole forming trocar; and
advancing the fastener into the pilot holes in the bone to fasten the sheet-like implant to the bone.

16. The method of claim 15 , wherein the fastener delivery device includes a pair of stakes engaged with a pair of arms of the fastener.

17. The method of claim 16 , wherein the pair of stakes of the fastener delivery device are advanced into the pilot holes as the arms of the fastener are advanced into the pilot holes.

18. The method of claim 15 , wherein the fastener is advanced into the pilot holes of the bone while the pair of position retention members remain in the pilot holes.

19. A fastener delivery system, comprising:
a position retention sleeve having a proximal end, a distal end, and a lumen extending therethrough;
wherein the distal end of the position retention sleeve comprises a pair of position retention members extending distally from the distal end of the position retention sleeve;
a pilot hole forming trocar removably disposed in the lumen of the position retention sleeve, the pilot hole forming trocar including two distally extending spikes extending distally beyond the pair of position retention members to form a pair of pilot holes in a bone; and
a fastener delivery device positionable in the lumen of the position retention sleeve;
wherein the fastener delivery device is configured to deliver a fastener into the pair of pilot holes formed by the trocar;
wherein the removable pilot hole forming trocar and the fastener delivery device are each configured and adapted to be releasably and slideably received within the lumen of the position retention sleeve; and
wherein the removable pilot hole forming trocar is removable from the position retention sleeve and replaceable by the fastener delivery device in the lumen of the position retention sleeve while retaining a position of the position retention sleeve with the pair of position retention members in the pilot holes.

20. The system of claim 19 , wherein the fastener delivery device comprises a pair of stakes which are received along the pair of position retention members and within the pilot holes when the fastener delivery device has replaced the removable pilot hole forming trocar within the lumen of the position retention sleeve.

Assignees

• Rotation Medical Inc

Inventors

• Euteneuer Charles L
• Westling Thomas A
• Zenz-Olson Nathaniel Z
• Witzmann Michael

Classifications

• A61B2017/3454

  Details of tips · CPC title

• A61B17/068

  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}) · CPC title

• A61F2/0811 Primary

  Fixation devices for tendons or ligaments · CPC title

• A61B17/1604

  Chisels; Rongeurs; Punches; Stamps · CPC title

• A61B2017/3488

  Fixation to inner organ or inner body tissue · CPC title