Implantable device fastening system and methods of use

• US 7,762,998 B2
• Filed: 09/15/2004
• Issued: 07/27/2010
• Est. Priority Date: 09/15/2003
• Status: Active Grant

• Current Assignee: ReShape LifeSciences, Inc.
• Original Assignee: Allergan, Inc. (Canada) (Abbvie Incorporated)
• Inventors: Coe, Frederick L., Hoyt, Robert E. Jr., Birk, Janel
• Primary Examiner(s): Lucchesi; Nicholas D
• Assistant Examiner(s): CHANDER, DIVA KAKAR
• Application Number:
  US10/562,964
• Publication Number:
  US 20060190039A1
• Time in Patent Office: 2,141 Days
• Field of Search: 604/513, 604/50, 604/288.01, 604/93.01, 604/175, 606/219, 606/217, 606/213, 606/139
• US Class Current: 604/288.01
• CPC Class Codes: A61B 17/064 Surgical staples, i.e. penetrating the tissue
• CPC Class Codes: A61B 17/0684 having a forming anvil staying above the tissue during stapling
• 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: A61F 5/0056 using injection ports
• CPC Class Codes: A61M 2039/0223 having means for anchoring the subcutaneous access site
• 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

Abstract

A surgical fastening system for implantable devices is disclosed. 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. An implantable injection port and deployment tool system, comprising:

an implantable injection port comprising a housing and a septum retained by the housing, one end of the septum forming an upper face of the port generally oriented in a plane perpendicular to a vertical axis, 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 fastener incorporated into the housing to enable a user to attach the port to tissue without sutures, the fastener having an undeployed position and a deployed position, the deployed position extending below a lower face of the port opposite the upper face; and

a deployment tool having a proximal shaft and a distal cover defining a recess that receives the port therein such that the lower face of the port is exposed, the cover and recess being oriented to extend down over the port generally vertically, the proximal shaft extending upward from the distal cover at an angle to the vertical and having a proximal manual actuator, the tool including a transmission in the shaft for transmitting movement of the actuator through elements in the shaft to the port for moving the fastener from its undeployed position to its deployed position and anchoring the port to tissue.

2. The system of claim 1, wherein the deployment tool is activated via a pencil-grip actuator, a palm-grip actuator or a pistol-grip actuator.

3. The system of claim 1, wherein the fastener pivotally rotates in the housing from the undeployed position to the deployed position.

4. The system of claim 3, wherein the transmission converts motion of the manual actuator into rotational motion about the vertical axis to cause the fastener to rotate.

5. The system of claim 1, wherein the fastener pivotally rotates in the housing from the undeployed position to the deployed position, and the port further comprises a rotating disc for rotating the fastener from the undeployed position to the deployed position, and wherein the deployment tool contacts and rotates the rotating disc.

6. The system of claim 5, wherein there are a plurality of the fasteners in the form of curved hooks distributed around the lower face of the port that each pivot from the undeployed position to the deployed position.

7. The system of claim 6, 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.

8. The system of claim 1, wherein there are a plurality of the fasteners in the form of curved hooks distributed around the lower face of the port that each pivot from the undeployed position to the deployed position.

9. The system of claim 8, 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.

10. An implantable injection port and deployment tool system, comprising:

an implantable injection port comprising a housing and a septum retained by the housing, one end of the septum forming an upper face of the port, 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 fastener incorporated into the housing to enable a user to attach the port to tissue without sutures, the fastener having an undeployed position and a deployed position, the deployed position extending below a lower face of the port opposite the upper face; and

a deployment tool having a proximal shaft and a distal cover with a recess that receives the port therein such that the lower face of the port is exposed, the proximal shaft extending upward from the distal cover and having a proximal manual actuator, the tool further including a transmission for transmitting movement of the actuator through elements in the shaft to the port for moving the fastener from its undeployed position to its deployed position and anchoring the port to tissue, the transmission including a mechanism to amplify the force imparted to the actuator to a larger force exerted on the fastener.

11. The system of claim 10, wherein the deployment tool is activated via a pencil-grip actuator, a palm-grip actuator or a pistol-grip actuator.

12. The system of claim 10, wherein the fastener pivotally rotates in the housing from the undeployed position to the deployed position.

13. The system of claim 12, wherein the transmission converts motion of the manual actuator into rotational motion about the vertical axis to cause the fastener to rotate.

14. The system of claim 10, wherein the fastener pivotally rotates in the housing from the undeployed position to the deployed position, and the port further comprises a rotating disc for rotating the fastener from the undeployed position to the deployed position, and wherein the deployment tool contacts and rotates the rotating disc.

15. The system of claim 14, wherein there are a plurality of the fasteners in the form of curved hooks distributed around the lower face of the port that each pivot from the undeployed position to the deployed position.

16. The system of claim 15, 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.

17. The system of claim 10, wherein there are a plurality of the fasteners in the form of curved hooks distributed around the lower face of the port that each pivot from the undeployed position to the deployed position.

18. The system of claim 17, 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.

19. An implantable injection port and deployment tool system, comprising:

an implantable injection port comprising a housing and a septum retained by the housing, one end of the septum forming an upper face of the port, 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 fastener incorporated into the housing to enable a user to attach the port to tissue without sutures, the fastener having an undeployed position and a deployed position, the deployed position extending below a lower face of the port opposite the upper face; and

a deployment tool having a proximal shaft and a distal cover with a recess that receives the port therein such that the lower face of the port is exposed, the proximal shaft extending upward from the distal cover and having a proximal palm-grip actuator, the tool including a transmission for transmitting movement of the actuator through elements in the shaft to the port for moving the fastener from its undeployed position to its deployed position and anchoring the port to tissue, the palm-grip actuator being angled with respect to the shaft and pivotally mounted with respect to a housing portion fixed to the shaft to enable an operator to squeeze the palm-grip actuator and housing portion together in his/her palm and deploy the fastener.

20. The system of claim 19, wherein the fastener pivotally rotates in the housing from the undeployed position to the deployed position.

21. The system of claim 20, wherein the transmission converts motion of the manual actuator into rotational motion about the vertical axis to cause the fastener to rotate.

22. The system of claim 19, wherein the fastener pivotally rotates in the housing from the undeployed position to the deployed position, and the port further comprises a rotating disc for rotating the fastener from the undeployed position to the deployed position, and wherein the deployment tool contacts and rotates the rotating disc.

23. The system of claim 22, wherein there are a plurality of the fasteners in the form of curved hooks distributed around the lower face of the port that each pivot from the undeployed position to the deployed position.

24. The system of claim 23, 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.

25. The system of claim 19, wherein there are a plurality of the fasteners in the form of curved hooks distributed around the lower face of the port that each pivot from the undeployed position to the deployed position.

26. The system of claim 25, 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.