Methods of implanting an injection port

• US 7,811,275 B2
• Filed: 06/19/2009
• Issued: 10/12/2010
• Est. Priority Date: 09/15/2003
• Status: Active Grant

• Current Assignee: Apollo Endosurgery US, Inc. (Boston Scientific Corporation)
• Original Assignee: Allergan, Inc. (Canada) (Abbvie Incorporated)
• Inventors: Birk, Janel A., Coe, Frederick L., Hoyt, Robert E.
• Primary Examiner(s): Lucchesi; Nicholas D
• Assistant Examiner(s): CHANDER, DIVA KAKAR
• Application Number:
  US12/488,364
• Publication Number:
  US 20090264827A1
• Time in Patent Office: 480 Days
• Field of Search: 604/50, 604/513, 604/502, 604/288.01, 604/93.01, 604/175, 606/219, 606/213, 606/217, 606/139
• US Class Current: 604/502
• 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 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 for implanting an injection port in tissue, comprising:

preparing an injection port for implant, the port including;

a housing defining a periphery and having an upper face generally oriented in a plane perpendicular to a vertical axis;

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

a space below the septum defining a fluid reservoir; and

a sharp-tipped fastener attached to the housing and mounted to move from an undeployed position not projecting below a lower face of the port opposite the upper face to a deployed position projecting below the lower face of the port; and

a disc that rotates about the vertical axis for pivoting the fastener from the undeployed position to the deployed position;

coupling the injection port to a distal end of a deployment tool having a manual actuator and a transmission connected thereto for rotating the disc;

inserting the distal end of the deployment tool with the injection port into a patient;

positioning the lower face of the port against tissue; and

operating the manual actuator to cause the sharp-tipped fastener to move from the undeployed position to the deployed position to pierce tissue and attach the port to the tissue without sutures.

2. The method 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 the rotating disc causes to simultaneously pivot from their undeployed positions to their deployed positions.

3. The method of claim 2, wherein sharp tips of the curved hooks pivot 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 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 their undeployed positions to their deployed positions.

5. The method of claim 4, wherein sharp tips of the curved hooks pivot through an arc and are received back in or near the lower face of the port at the end of their travel.

6. The method of claim 4, wherein the hooks pivot about axes that are generally radially oriented outward from a center at the vertical axis.

7. The method of claim 4, wherein the hooks pivot about axes that are generally tangential to a circle with a center at the vertical axis.

8. The method of claim 4, wherein there are at least three hooks.

9. The method of claim 1, wherein the deployment tool has 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 the transmission being located in the shaft.

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

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

12. The method of claim 11, wherein distal tips of the fasteners pivot through an arc and are received back in or near the lower face of the port at the end of their travel.

13. The method of claim 11, wherein there are at least three fasteners.

14. The method of claim 11, wherein each fastener produces an audible click indicating that the fastener has pivoted completely to the deployed position.

15. The method of claim 11, wherein the rotating disc directly contacts the hooks.

16. The method of claim 11, further including locking tabs that engage stops and preventing backward rotation of the disc after pivoting the fasteners from their undeployed positions to their deployed positions.

17. The method of claim 11, wherein the curved metal fasteners have sharp tips.

18. The method of claim 10, wherein the hooks pivot about axes that are generally radially oriented outward from a center at the vertical axis.

19. The method of claim 10, wherein the hooks pivot about axes that are generally tangential to a circle with a center at the vertical axis.

20. The method of claim 10, wherein there are at least three hooks.

21. The method of claim 10, wherein each hook produces an audible click indicating that the hook has pivoted completely to the deployed position.

22. The method of claim 10, wherein the port further comprises a disc that rotates about the vertical axis for simultaneously pivoting the hooks from their undeployed positions to their deployed positions.

23. The method of claim 1, wherein the transmission converts motion of the manual actuator into rotational motion about the vertical axis to cause the disc to rotate.

24. The method of claim 1, wherein the transmission includes a mechanism to amplify the force imparted to the actuator to a larger force exerted on the disc.

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

26. The method of claim 25, wherein the rotating disc directly contacts the hooks.

27. The method of claim 25, further including locking tabs that engage stops and preventing backward rotation of the disc after pivoting the hooks from their undeployed positions to their deployed positions.

28. The method of claim 1, wherein the transmission converts motion of the manual actuator into rotational motion about the vertical axis to cause the disc to rotate.

29. The method of claim 1, wherein the transmission includes a mechanism to amplify the force imparted to the actuator to a larger force exerted on the disc.

30. A method for implanting an injection port in tissue, comprising:

preparing an injection port for implant, the port including;

a housing having an upper face generally oriented in a plane perpendicular to a vertical axis;

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

a space below the septum defining a fluid reservoir;

a plurality of curved hooks attached to the housing and distributed around a lower face of the port opposite the upper face, each hook mounted to pivot 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; and

a disc that rotates about the vertical axis for simultaneously pivoting the hooks from their undeployed positions to their deployed positions;

inserting the injection port into a patient;

positioning the lower face of the port against tissue; and

rotating the disc to cause the hooks to move from their undeployed positions to their deployed positions to pierce tissue and attach the port to the tissue without sutures.

31. The method of claim 30, coupling the injection port to a distal end of a deployment tool having a manual actuator and a transmission connected thereto for rotating the disc.

32. The method of claim 30, wherein the deployment tool has 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 the transmission being located in the shaft.

33. A method for implanting an injection port in tissue, comprising:

preparing an injection port for implant, the port including;

a housing having a generally circular periphery defining a central axis and an upper face;

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

a space below the septum defining a fluid reservoir;

a plurality of curved metal fasteners attached to the housing and distributed circumferentially around a lower face of the port opposite the upper face, each fastener mounted to pivot about an axis that is generally radially oriented outward from the central axis from an undeployed position not projecting below the lower face of the housing to a deployed position projecting below the lower face of the housing; and

a disc that rotates about the central axis for simultaneously pivoting the fasteners from their undeployed positions to their deployed positions;

inserting the injection port into a patient;

positioning the lower face of the port against tissue; and

rotating the disc to cause the fasteners to move from their undeployed positions to their deployed positions to pierce tissue and attach the port to the tissue without sutures.