Methods of operating an implantable injection port system

• US 8,079,989 B2
• Filed: 10/28/2009
• Issued: 12/20/2011
• Est. Priority Date: 09/15/2003
• Status: Active Grant

• Current Assignee: ReShape LifeSciences, Inc.
• Original Assignee: Allergan, Inc. (Canada) (Abbvie Incorporated)
• Inventors: Birk, Janel A., Coe, Frederick L., Hoyt, Robert E.
• Primary Examiner(s): Robert, Eduardo C
• Assistant Examiner(s): Spatafore, Paul J
• Application Number:
  US12/607,283
• Publication Number:
  US 20100042052A1
• Time in Patent Office: 783 Days
• Field of Search: 604/93.01, 604/175, 60428801-28804, 606/139, 606/213, 606/217, 606/219
• US Class Current: 604/288.01
• CPC Class Codes: A61B 17/064 Surgical staples, i.e. penetrating the tissue
• CPC Class Codes: A61B 17/068 Surgical staplers , e.g. containing multiple staples or clampsstaplers containing only one staple A61B17/10; magazines or containers for staples A61B17/105; for performing anastomosis A61B17/115; staplers in general B25C5/00
• CPC Class Codes: A61B 17/0684 having a forming anvil staying above the tissue during stapling
• CPC Class Codes: A61B 2017/00867 shape memory effect for prostheses A61F2210/0014
• CPC Class Codes: A61B 2017/0647 having one single leg, e.g. tacks
• CPC Class Codes: A61B 2017/0649 Coils or spirals
• CPC Class Codes: A61M 2039/0223 having means for anchoring the subcutaneous access site
• CPC Class Codes: A61M 2039/0229 having means for facilitating assembling, e.g. snap-fit housing or modular design
• CPC Class Codes: A61M 39/0208 Subcutaneous access sites for injecting or removing fluids transcutaneous access sites A61M39/0247; implantable infusion devices A61M5/14276
• CPC Class Codes: A61M 39/04 having pierceable self-sealing members
• CPC Class Codes: A61M 5/1415 Stands, brackets or the like for supporting infusion accessories

Abstract

A surgical fastening system for implantable devices such as injection port systems. The implantable device may contain a plurality of fasteners in pre-deployment position, may have a housing fitted over or around it which contains a plurality of fasteners in pre-deployment position, or may be a part of a two-part system into which it fits. Accordingly, the present invention also encompasses a deployment system or tool that optionally positions the implantable device, and which causes the fasteners to move into post-deployment position. The fasteners may be staples, metal loops, coils, springs or hooks formed of biocompatible materials, including shape memory alloys such as NiTi.

Claims

1. A method of operating an implantable injection port system, comprising:

providing an implantable injection port having a housing defining an upper face, a lower face, and a peripheral outer wall, a septum held within the housing and open to the upper face, the septum being capable of penetration by a needle along the vertical axis, the port further including a space below the septum defining a fluid reservoir and an outlet conduit through the housing from the reservoir, wherein the port further includes a plurality of fasteners incorporated into the housing to enable a user to attach the port to tissue without sutures, the fasteners each having an undeployed position and a deployed position, the deployed position extending below the lower face of the port;

providing a protective fixture adapted to removably attach over the lower face of the port to protect a user from contacting the fastener;

providing a deployment tool having a distal end with a recess that receives the port therein such that the lower face of the port is exposed, the tool including a mechanism for transmitting movement of a proximal actuator to the port for moving the fasteners from their undeployed positions to their deployed positions;

with the protective fixture attached over the lower face of the port, inserting the port upper face first into the recess of the tool distal end;

disengaging the protective fixture from the port; and

implanting the port.

2. The method of claim 1, wherein the protective fixture includes tabs that engage the housing lower face.

3. The method of claim 2, wherein the tabs have ribs that snap onto complementary features on the housing lower face.

4. The method of claim 1, wherein the protective fixture includes pegs that engage the housing lower face.

5. The method of claim 1, wherein the housing and protective fixture snap together.

6. The method of claim 1, wherein the protective fixture includes a main portion that snaps to the housing and at least one grasping tab extending radially therefrom to facilitate removal of the protective fixture from the housing.

7. The method of claim 1, wherein the protective fixture includes an annular wall that surrounds the housing.

8. The method of claim 7, wherein the annular wall is interrupted by a passageway therein to accommodate the outlet conduit, or tubing connected thereto, extending from the housing.

9. The method of claim 1, wherein the fasteners each pivotally rotates in the housing from the undeployed position to the deployed position.

10. The method of claim 9, wherein the fasteners comprise curved hooks distributed around the lower face of the port that each pivots from the undeployed position to the deployed position.

11. The method of claim 10, wherein sharp tips of the curved hooks rotate through an arc and are received back in or near the lower face of the port at the end of their travel.

12. A method of operating an implantable injection port system, comprising:

providing an implantable injection port having an upper face, a lower face, and a septum open to the upper face, the septum being capable of penetration by a needle along the vertical axis, the port further including a space below the septum defining a fluid reservoir and having an outlet conduit extending sideways away from the port, wherein the port further includes a plurality of sharp fasteners incorporated therein to enable a user to attach the port to tissue without sutures, the fasteners each having an undeployed position and a deployed position, the deployed position extending below the lower face of the port;

providing a protective fixture snapped over the lower face of the port to protect a user from contacting the sharp fastener;

providing a deployment tool having a distal end having an open bottom that descends down over and captures the port therein upper face first, the tool having an actuator for moving the fasteners from their undeployed positions to their deployed positions;

inserting the port upper face first into the recess of the tool distal end;

unsnapping the protective fixture from the port; and

moving the fasteners from their undeployed positions to their deployed positions into tissue, thus implanting the port.

13. The method of claim 12, wherein the protective fixture includes tabs that engage the housing lower face.

14. The method of claim 13, wherein the tabs have ribs that snap onto complementary features on the housing lower face.

15. The method of claim 12, wherein the protective fixture includes pegs that engage the housing lower face.

16. The method of claim 12, wherein the protective fixture includes a main portion that snaps to the housing and at least one grasping tab extending radially therefrom to facilitate removal of the protective fixture from the housing.

17. The method of claim 12, wherein the protective fixture includes an annular wall that surrounds the housing.

18. The method of claim 17, wherein the annular wall is interrupted by a passageway therein to accommodate the outlet conduit, or tubing connected thereto, extending from the housing.

19. The method of claim 12, wherein the fasteners each pivotally rotates in the housing from the undeployed position to the deployed position.

20. The method of claim 19, wherein the fasteners comprise curved hooks distributed around the lower face of the port that each pivots from the undeployed position to the deployed position.

21. The method of claim 20, wherein sharp tips of the curved hooks rotate through an arc and are received back in or near the lower face of the port at the end of their travel.