Methods of deploying an implantable injection port

• US 8,317,761 B2
• Filed: 06/14/2011
• Issued: 11/27/2012
• 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): Lucchesi, Nicholas
• Assistant Examiner(s): CHANDER, DIVA KAKAR
• Application Number:
  US13/159,883
• Publication Number:
  US 20110245595A1
• Time in Patent Office: 532 Days
• Field of Search: 604/93.01, 604/288.01
• 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 is disclosed. The implantable device may contain a plurality of fasteners in pre-deployment position, may have a housing fitted over or around fit 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 deploying an implantable injection port, comprising:

preparing an injection port for implant, the port including;

a housing defining a periphery around a vertical axis and having an upper face and a lower face opposite the upper face;

a septum within the housing open to the upper face and capable of penetration by a needle;

a space below the septum and within the housing defining a fluid reservoir; and

a plurality of sharp-tipped fasteners rotatably mounted to the housing to rotate from an undeployed position not projecting below the lower face of the port to a deployed position projecting below the lower face of the port;

covering the injection port with a distal cover of a delivery system having a proximal handle terminating in a manual actuator;

positioning the injection port lower surface on the bodily tissue;

activating the manual actuator such that the sharp-tipped fasteners rotate from their undeployed positions to their deployed positions to secure the injection port in bodily tissue; and

,

removing the delivery system from the secured injection port.

2. The method of claim 1, wherein the injection port is for use with a hydraulic operated gastric band and the method further includes fluidly connecting the access port to the gastric band.

3. The method of claim 1, wherein the sharp tips of the fasteners rotate through an arc and are received back in or near the lower face of the port at the end of their travel.

4. The method of claim 1, wherein the sharp-tipped fasteners rotate about axes that are generally radially oriented outward from a center at the vertical axis.

5. The method of claim 1, wherein the injection port includes a rotating member mounted to rotate about the vertical axis that acts on all of the sharp-tipped fasteners simultaneously, and wherein the step of activating the manual actuator rotates the rotating member.

6. The method of claim 5, wherein the delivery system further includes a transmission located in the shaft transmitting linear movement of the manual actuator through elements in the shaft to the injection port and rotating the rotating member.

7. The method of claim 1, wherein the delivery system further includes a transmission located in the shaft transmitting movement of the manual actuator through elements in the shaft to the injection port for moving the fasteners from their undeployed positions to their deployed positions, wherein the transmission includes a mechanism to amplify the force imparted to the manual actuator to a larger force exerted on the fasteners.

8. The method of claim 1, wherein the manual actuator is a palm-grip actuator 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.

9. The method of claim 1, wherein the injection port further includes a safety member removably attached over the lower surface and covering the sharp-tipped fasteners, the method further including removing the safety member from the injection port prior to positioning the lower surface of the injection port on the bodily tissue.

10. The method of claim 1, further comprising the step of rotating the fasteners from their deployed positions to their undeployed positions, thereby detaching the injection port from the bodily tissue.

11. The method of claim 1, wherein the method includes locking the sharp-tipped fasteners into the deployed position.

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

preparing an injection port for implant, the port including;

a housing defining a periphery around a vertical axis and having an upper face and a lower face opposite the upper face;

a septum within the housing open to the upper face and capable of penetration by a needle;

a space below the septum and within the housing defining a fluid reservoir; and

a plurality of sharp-tipped fasteners incorporated into the housing and mounted to move from an undeployed position not projecting below the lower face of the port to a deployed position projecting below the lower face of the port;

covering the injection port with a distal cover of a delivery system having a proximal handle terminating in a manual actuator;

positioning the injection port lower surface on the bodily tissue;

activating the delivery system such that the sharp-tipped fasteners move from their undeployed positions to their deployed positions;

reversing the movement of the sharp-tipped fasteners so that they resume their undeployed positions;

repositioning the injection port;

activating the delivery system again such that the sharp-tipped fasteners move from their undeployed positions to their deployed positions to secure the injection port in bodily tissue; and

,

removing the delivery system from the secured injection port.

13. The method of claim 12, wherein the injection port is for use with a hydraulic operated gastric band and the method further includes fluidly connecting the access port to the gastric band.

14. The method of claim 12, wherein the sharp tips of the fasteners move through an arc and are received back in or near the lower face of the port at the end of their travel.

15. The method of claim 12, wherein the injection port includes a rotating member mounted to rotate about the vertical axis that acts on all of the sharp-tipped fasteners simultaneously, and wherein the step of activating the manual actuator rotates the rotating member.

16. The method of claim 15, wherein the delivery system further includes a transmission located in the shaft transmitting linear movement of the manual actuator through elements in the shaft to the injection port and rotating the rotating member.

17. The method of claim 12, wherein the delivery system further includes a transmission located in the shaft transmitting movement of the manual actuator through elements in the shaft to the injection port for moving the fasteners from their undeployed positions to their deployed positions, wherein the transmission includes a mechanism to amplify the force imparted to the manual actuator to a larger force exerted on the fasteners.

18. The method of claim 12, wherein the manual actuator is a palm-grip actuator 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.

19. The method of claim 12, wherein the injection port further includes a safety member removably attached over the lower surface and covering the sharp-tipped fasteners, the method further including removing the safety member from the injection port prior to positioning the lower surface of the injection port on the bodily tissue.

20. A method of deploying an implantable injection port, comprising:

preparing an injection port for implant, the port including;

a housing defining a periphery around a vertical axis and having an upper face and a lower face opposite the upper face;

a septum within the housing open to the upper face and capable of penetration by a needle;

a space below the septum and within the housing defining a fluid reservoir; and

a plurality of sharp-tipped fasteners incorporated into the housing and mounted to move from an undeployed position not projecting below the lower face of the port to a deployed position projecting below the lower face of the port;

covering the injection port with a distal cover of a delivery system, the distal cover defining a recess that receives and engages 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 delivery system having a proximal shaft extending upward from the distal cover at an angle to the vertical and terminating in a manual actuator;

positioning the injection port lower surface on the bodily tissue;

activating the manual actuator such that the sharp-tipped fasteners move from their undeployed positions to their deployed positions to secure the injection port in bodily tissue; and

,

removing the delivery system from the secured injection port.

21. The method of claim 20, wherein the injection port is for use with a hydraulic operated gastric band and the method further includes fluidly connecting the access port to the gastric band.

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

23. The method of claim 20, wherein the injection port includes a rotating member mounted to rotate about the vertical axis that acts on all of the sharp-tipped fasteners simultaneously, and wherein the step of activating the manual actuator rotates the rotating member.

24. The method of claim 23, wherein the delivery system further includes a transmission located in the shaft transmitting linear movement of the manual actuator through elements in the shaft to the injection port and rotating the rotating member.

25. The method of claim 20, wherein the delivery system further includes a transmission located in the shaft transmitting movement of the manual actuator through elements in the shaft to the injection port for moving the fasteners from their undeployed positions to their deployed positions, wherein the transmission includes a mechanism to amplify the force imparted to the manual actuator to a larger force exerted on the fasteners.

26. The method of claim 20, wherein the manual actuator is a palm-grip actuator 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.

27. The method of claim 20, wherein the injection port further includes a safety member removably attached over the lower surface and covering the sharp-tipped fasteners, the method further including removing the safety member from the injection port prior to positioning the lower surface of the injection port on the bodily tissue.

28. The method of claim 20, wherein the method includes locking the sharp-tipped fasteners into the deployed position.

29. The method of claim 20, further comprising the step of rotating the fasteners from their deployed positions to their undeployed positions, thereby detaching the injection port from the bodily tissue.

30. The method of claim 29, further comprising the steps of:

disposing the injection port at a second location on bodily tissue; and

again pivoting the fasteners from their undeployed positions to their deployed positions, thereby attaching the injection port to the bodily tissue at the second location.