Temporary retention device

• US 7,931,658 B2
• Filed: 03/18/2005
• Issued: 04/26/2011
• Est. Priority Date: 09/20/2002
• Status: Active Grant

• Current Assignee: Interrad Medical, Inc.
• Original Assignee: Interrad Medical, Inc.
• Inventors: Rosenberg, Michael S., Claude, Timothy J.
• Primary Examiner(s): Severson; Ryan J
• Application Number:
  US11/085,016
• Publication Number:
  US 20050187578A1
• Time in Patent Office: 2,230 Days
• Field of Search: 606/108, 600/184, 600/217, 604/93.01, 60416401-16408, 604/174, 607/128
• US Class Current: 606/108
• CPC Class Codes: A61B 17/3478 Endoscopic needles, e.g. for infusion biopsy needles A61B10/0233; catheters with injection needles A61M25/0067
• CPC Class Codes: A61B 2017/3484 Anchoring means, e.g. spreading-out umbrella-like structure
• CPC Class Codes: A61M 2025/0293 Catheter, guide wire or the like with means for holding, centering, anchoring or frictionally engaging the device within an artificial lumen, e.g. tube natural lumen, e.g. vessels A61M25/04
• CPC Class Codes: A61M 25/02 Holding devices, e.g. on the body
• CPC Class Codes: A61M 25/04 in the body, e.g. expansible A61M25/10, A61M16/0488 take precedence

Abstract

A retention device for anchoring indwelling catheters, sheath introducers, feeding tubes, ostomy bags or other medical devices beneath the skin of a patient includes an deployable section coupled to a medical device; following introduction into a patient, the deployable section is subcutaneously deployed, securely anchoring the device and coupled medical device for the duration of treatment.

Claims

1. A device for subcutaneously anchoring a removably coupled catheter device within a patient, comprising:

a catheter retainer body including a catheter-receiving channel extending to a distal opening, and a deployable anchor section that is spaced apart from the catheter-receiving channel and that includes a curved anchor tine extending from a longitudinally straight rod portion attached to the catheter retainer body, wherein when the removably coupled catheter device is positioned through a skin puncture, the deployable anchor section is positioned through the same skin puncture to deploy the curved anchor tine subcutaneously along an underside of a skin layer in a controllable manner by flexibly adjusting the curved anchor tine so that a free end of the curved anchor tine is adapted to engage tissue along the underside of the skin layer, wherein a longitudinal length of the curved anchor tine extends outwardly away from the longitudinally straight rod portion with a longitudinal convex curvature extending toward the free end of the curved anchor tine such that the longitudinal convex curvature faces proximally toward catheter retainer body.

2. The device of claim 1 further comprising the deployable anchor section attached to a platform with the deployable anchor section capable of transitioning between a first configuration and a second configuration extending from the platform.

3. The device of claim 2 wherein the deployable anchor section is capable of repeatedly moving between the first configuration and the second configuration.

4. The device of claim 1 wherein the deployable anchor section comprises stainless steel.

5. The device of claim 1 wherein the deployable anchor section comprises nitinol processed to exhibit superelasticity at a temperature below human body temperature.

6. A device for subcutaneously anchoring a coupled medical device within a patient, comprising:

a. a retainer body including a channel extending to a distal facing opening and being configured to releasable engage with an outer surface of a medical device; and

b. an anchor mechanism contacting the retainer body and being spaced apart from the channel extending to the distal facing opening of the retainer body, the anchor mechanism including a curved anchor extension that extends outwardly from a rod to a free end terminating at a dull or rounded tip, at least a portion of the extension is capable of flexibly adjusting from a first position to a subcutaneously deployed position so that the free end of the curved anchor extension is adapted to engage tissue along an underside of a skin layer, whereby deployment of the curved anchor extension of the anchor mechanism to the subcutaneously deployed position results in a longitudinal length of the curved anchor extension extending outwardly away from the rod such that a longitudinal convex curvature extends toward the free end of the extension and faces proximally toward the retainer body.

7. The device of claim 6 wherein the anchor mechanism is movable relative to the retainer body so that at least a portion of the extension of the anchor mechanism is adapted to move toward the subcutaneously deployed position.

8. The device of claim 6 wherein the extension has a trained shape when in the subcutaneously deployed position.

9. The device of claim 8 wherein the extension comprises a curved anchor tine having a first end and the free end terminating at a dull or rounded tip.

10. The device of claim 6 wherein the retainer body comprises an anchor sleeve defining a chamber and the anchor mechanism is loaded into the chamber.

11. The device of claim 10 wherein the anchor sleeve defines a number of ports equal to the number of tines such that a tine moves out of each port when the device is put into the subcutaneously deployed position.

12. The device of claim 10 further comprising means for biasing the anchor mechanism for deployment of the extension.

13. The device of claim 12 wherein the biasing means is a spring that is integrally attached to the anchor mechanism.

14. The device of claim 12 wherein the biasing means is a spring that is separately formed from the anchor mechanism.

15. The device of claim 10 further comprising a control member configured to contact and move the anchor mechanism.

16. The device of claim 6 wherein the anchor mechanism is made of a nitinol alloy.

17. The device of claim 16 wherein the nitinol anchor mechanism is processed to exhibit superelasticity at a temperature below human body temperature.

18. The device of claim 16 wherein the anchor mechanism is cut from nitinol sheet material.

19. The device of claim 16 wherein the anchor mechanism is cut from nitinol tubing.

20. The device of claim 6 wherein the anchor mechanism is made of stainless steel.

21. A device for subcutaneously anchoring a coupled medical device within a patient, comprising:

an elongate body at least partially defining an internal chamber that is in communication with one or more deployment ports defined along an exterior of the elongate body, the elongate body including a channel extending to a distally oriented opening and configured to releasably engage an outer surface of a medical device; and

an anchor mechanism at least partially arranged in the internal chamber defined by the elongate body such that the anchor mechanism is isolated from the channel of the elongate body, the anchor mechanism comprising a pair of subcutaneous tines that are biased to extend outwardly away from one another and that are flexibly adjustable from a non-deployed position to a deployed position in which the pair of subcutaneous tines extend from the one or more deployment ports and outwardly away from one another in a subcutaneous region,

wherein the elongate body is positioned relative to the anchor mechanism such that longitudinal actuation of the anchor mechanism causes the pair of subcutaneous tines to simultaneously move to the deployed position in the subcutaneous region under a skin layer when the elongate body is arranged adjacent to a skin puncture in the skin layer.

22. The device of claim 21, wherein the anchor mechanism further comprises a control rod coupled to the pair of subcutaneous tines, at least a portion of the control rod being longitudinally movable within the internal chamber.

23. The device of claim 22, wherein the pair of subcutaneous tines are repeatedly movable between the non-deployed position and the deployed position.

24. The device of claim 23, wherein the pair of subcutaneous tines comprise a metallic alloy that exhibits superelastic characteristics such that the subcutaneous tines superelastically flex when moving between the non-deployed position and the deployed position.

25. The device of claim 24, wherein the pair of subcutaneous tines flex when moving between the non-deployed position and the deployed position without taking a permanent set or kink.

26. The device of claim 24, wherein the pair of subcutaneous tines comprise nitinol.

27. The device of claim 24, wherein the pair of subcutaneous tines exhibit superelasticity at about 37 degrees C.

28. The device of claim 21, wherein each of the subcutaneous tines at least partially defines an arc shape when moved to the deployed position, wherein the arc shape of each subcutaneous tine comprises a longitudinal convex curvature that faces toward the underside of the skin layer when each subcutaneous tine is moved to the deployed position.

29. The device of claim 21, wherein the elongate body comprises an anchor sleeve having a distal portion deliverable to the subcutaneous region while a proximal portion resides outside the skin.

30. The device of claim 21, wherein the channel is configured to releasably engage the medical device such that the catheter device passes through the same skin puncture as the pair subcutaneous tines when moved to the deployed position.

31. The device of claim 21, wherein the elongate body comprises an anchor sleeve integrally attached to a catheter device.

32. A device for subcutaneously anchoring a coupled medical device within a patient, comprising:

an elongate body at least partially defining an internal chamber that is in communication with one or more deployment ports defined along an exterior of the elongate body, the elongate body including a channel extending to a distally oriented opening and configured to releasable engage an outer surface of a medical device; and

an anchor mechanism at least partially arranged in the internal chamber such that the anchor mechanism is isolated from the channel of the elongate body, the anchor mechanism comprising one or more subcutaneous tines that are movable from a non-deployed position to a deployed position in which the one or more tines extend from the one or more deployment ports defined along an exterior of the elongate body,

wherein the one or more subcutaneous tines move to the deployed position in the subcutaneous region under the skin layer in response to user actuation of the anchor mechanism when the one or more deployment ports are arranged in the subcutaneous region;

wherein each of the one or more subcutaneous tines has a longitudinal length at least partially defines an arc shape when moved to the deployed position; and

wherein the arc shape of the subcutaneous tine comprises a longitudinal convex curvature that faces toward the underside of the skin when the subcutaneous tine is moved to the deployed position.

33. The device of claim 32, wherein the anchor mechanism further comprises a control rod coupled to the one or more subcutaneous tines, at least a portion of the control rod being longitudinally movable within the internal chamber of the elongate body.

34. The device of claim 32, wherein the one or more subcutaneous tines are flexible to repeatedly move between the non-deployed position in which each subcutaneous tine has a first curved shape and the deployed position in which each subcutaneous tine has a second curved shape different from the first curved shape.

35. The device of claim 32, wherein the one or more subcutaneous tines comprise a metallic alloy that exhibits superelastic characteristics such that the subcutaneous tines superelastically flex when moving between the non-deployed position and the deployed position.

36. The device of claim 32, wherein the elongate body is at least part of an anchor sleeve having a distal portion deliverable to the subcutaneous region while a proximal portion resides outside the skin.

37. The device of claim 32, wherein the anchor is coupled to an introducer sheath having a lumen to receive a catheter device.

38. The device of claim 32, wherein the elongate body comprises an anchor sleeve integrally attached to a catheter device.