Implantable device fastening system

• US 8,496,614 B2
• Filed: 07/26/2010
• Issued: 07/30/2013
• Est. Priority Date: 09/15/2003
• Status: Active Grant

• Current Assignee: ReShape LifeSciences, Inc.
• Original Assignee: Allergan Incorporated (Abbvie Incorporated)
• Inventors: Birk, Janel, Coe, Frederick L., Hoyt, Robert E. Jr.
• Primary Examiner(s): Lucchesi, Nicholas
• Assistant Examiner(s): CHANDER, DIVA KAKAR
• Application Number:
  US12/843,629
• Publication Number:
  US 20100286649A1
• Time in Patent Office: 1,100 Days
• Field of Search: 604/93.01, 604/288.01
• US Class Current: 604/93.01
• 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 delivery tool system, comprising:

an implantable injection port comprising a base, a septum being capable of penetration by a needle above the base, a space below the septum defining a fluid reservoir, a plurality of fasteners pivotally connected to the base and movable between an undeployed position and a deployed position, and a first rotatable element connected to the base, the first rotatable element being structured and positioned to cause deployment of the plurality of fasteners upon rotation of the first rotatable element; and

a delivery tool for facilitating implantation of the injection port into soft tissue, the delivery tool comprising;

a second rotatable element configured to removably engage the first rotatable element, and

an activation assembly effective to move the fasteners into the deployed position, the activation assembly having a transmission element operationally coupled to the second rotatable element.

2. The system of claim 1, wherein the activation assembly is structured such that linear movement of the transmission element causes rotational movement of the second rotatable element.

3. The system of claim 1, wherein the first rotatable element comprises a rotating disc.

4. The system of claim 3, wherein the second rotating element comprises an actuation edge structured to contact a portion of the rotating disc when the delivery tool is caused to engage the implantable injection port.

5. The system of claim 3, wherein the implantable injection port further includes at least one locking tab that engages a stop and prevents backward rotation of the disc after pivoting the fasteners from the undeployed to the deployed position.

6. The system of claim 1, wherein the fasteners are in the form of curved hooks distributed around a lower face of the implantable injection port that simultaneously pivot from their undeployed to their deployed position, the deployed positions of the fasteners extending below a lower face of the implantable injection port.

7. The system of claim 6, wherein the hooks pivot about axes that are generally radially oriented outward from a center at a vertical axis.

8. The system of claim 6, wherein the hooks pivot about axes that are generally tangential to a circle with a center at a vertical axis.

9. The system of claim 6, wherein each hook produces an audible click indicating that the hook has pivoted completely to the deployed position.

10. 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 implantable injection port at the end of the arc.

11. The system of claim 1, wherein the delivery tool further comprises:

a proximal shaft;

a distal cover defining a recess that receives the implantable injection port therein such that a 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 to a proximal handle and manual actuator.

12. The system of claim 11, wherein the proximal shaft extends upward at an angle to the vertical from the distal cover to the proximal handle.

13. The system of claim 11, wherein the manual actuator is a palm-grip actuator angled with respect to the shaft, the palm-grip actuator including a lever connected to the transmission element and pivotally mounted with respect to a housing portion to enable an operator to squeeze the lever and housing portion together in his/her palm and deploy the fasteners.

14. The system of claim 13, wherein the delivery tool includes a plunger mounted to slide linearly through a portion of the shaft and displaced by the lever of the palm-grip actuator.

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

an implantable injection port comprising a generally cylindrical housing, a septum retained by the housing and capable of penetration by a needle, a space below the septum along a central axis of the generally cylindrical housing defining a fluid reservoir, a plurality of soft tissue fasteners arrayed circumferentially around the central axis and pivotally connected to the housing to rotate about radial axes, and a first rotatable element mounted to the housing to rotate about the central axis, the first rotatable element being structured and positioned to cause deployment of the plurality of fasteners upon rotation of the first rotatable element; and

a deployment tool having a distal cover defining a recess that receives the implantable injection port therein, the cover and recess being oriented to extend down over the port generally vertically along the central axis, the tool having a second rotatable element in the distal cover configured to removably engage the first rotatable element and deploy the fasteners.

16. The system of claim 15, wherein the tool includes a transmission for transmitting movement of a proximal manual actuator to the second rotatable element, wherein the transmission converts linear or pivoting motion of the manual actuator into rotational motion about the central axis.

17. The system of claim 15, wherein the manual actuator comprises a palm-grip actuator on the proximal end of a shaft, and the transmission includes elements in the shaft, 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 fasteners.

18. The system of claim 15, wherein the manual actuator comprises a palm-grip actuator on the proximal end of a shaft, wherein the delivery tool includes a plunger mounted to slide linearly through a portion of the shaft and displaced by the lever of the palm-grip actuator.

19. The system of claim 15, wherein the fasteners comprise curved hooks distributed around the lower face of the port that each pivot from the undeployed position to the deployed position.

20. 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.

21. The system of claim 15, wherein the first rotatable element comprises a rotating disc.

22. The system of claim 21, wherein the second rotating element comprises an actuation edge structured to contact a portion of the rotating disc when the delivery tool is caused to engage the implantable injection port.

23. The system of claim 21, wherein the implantable injection port further includes at least one locking tab that engages a stop and prevents backward rotation of the disc after pivoting the fasteners from the undeployed to the deployed position.

24. The system of claim 15, wherein each fastener produces an audible click indicating that the fastener has pivoted completely to the deployed position.