Temporary retention device

• US 20050187578A1
• Filed: 03/18/2005
• Published: 08/25/2005
• 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.
• Granted Patent: US 7,931,658 B2
• Time in Patent Office: Days
• US Class Current: 606/232
• 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
• 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 coupled medical device within a patient, comprising a distal section and a proximal section with a deployable section attached proximate the proximal section wherein when the device is introduced the deployable section when deployed deploys subcutaneously in a controllable manner.

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

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

4. The device of claim 1 wherein the deployable section is made of nitinol.

5. The device of claim 4 wherein the deployable section is made of 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 restraint;

b. an anchor mechanism contacting the restraint, at least a portion of the anchor mechanism capable of transitioning between a first configuration when restrained by the restraint and a second configuration when unrestrained by the restraint, the anchor mechanism having at least a single extension, at least a portion of the extension is capable of flexibly and repeatedly moving between the first configuration and the second configuration; and

c. the device defining a distal section and a proximal section, the restraint and anchor mechanism proximate the proximal section;

whereby separating the anchor mechanism and the restraint from each other following introduction of the device unrestrains the extension in a gradual and controlled manner causing the extension to gently transition from the first configuration toward the second configuration, resulting in subcutaneous deployment of the extension.

7. The device of claim 6 wherein the restraint is fixed and the anchor mechanism is movable so that at least a portion of the extension of the anchor mechanism can move toward the unrestrained second configuration.

8. The device of claim 6 wherein the extension has a trained shape when in the second configuration.

9. The device of claim 6 wherein the restraint further comprises an anchoring sleeve defining a chamber and the anchor mechanism is loaded into the chamber.

10. The device of claim 9 further comprising a control member configured to contact and move the anchor mechanism.

11. The device of claim 8 wherein the extension further comprises at least a single tine having a first end and a second free end.

12. The device of claim 9 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 second configuration.

13. The device of claim 9 wherein the biasing means is a spring attached to the anchor mechanism.

14. The device of claim 9 wherein the spring is integrally attached to the anchor mechanism.

15. The device of claim 9 wherein the spring is separate from 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 6 wherein the anchor mechanism is made of stainless steel.

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

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

21. The device of claim 6 wherein the anchor mechanism is fixed and the restraint is capable of moving to allow at least a portion of the anchor mechanism to move toward the unrestrained second configuration.

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

a. an anchor sleeve having a chamber defining at least a single port;

b. an anchor mechanism movably loaded into the chamber, the anchor mechanism capable of moving between a restrained first configuration and an unrestrained second configuration, the anchor mechanism having;

i at least a single tine having a first end and a second free end,

(1) the second end of the tine is capable of flexibly and repeatedly moving between the first configuration and the second configuration,

(2) the tine having a trained shape when in the second configuration,

(3) the length of the tine is such that the tine is restrained within the chamber when the anchor mechanism is in the first configuration, and

(4) the port is sized and located so the free end of the tine is proximate the port when the tine is in the first configuration;

ii. biasing means to move the anchor mechanism into the second configuration; and

iii. a removable actuation key sized to fit into the anchor sleeve to contact the anchor mechanism;

whereby inserting the key into the anchor sleeve moves the anchor mechanism from the second configuration and retains in the first configuration causing the second end of the tine to enter the chamber through the port.

23. The device of claim 22 wherein the biasing means is a spring attached to the anchor mechanism.

24. The device of claim 23 wherein the biasing means is a spring integrally attached to the anchor mechanism.

25. The device of claim 22 wherein the biasing means is a spring separate from the anchor mechanism.

26. The device of claim 22 wherein the anchor mechanism is made of a nitinol alloy.

27. The device of claim 26 wherein the nitinol anchor mechanism is processed to exhibit superelasticity at a temperature below human body temperature.

28. The device of claim 22 wherein the anchor mechanism is made of stainless steel.

29. The device of claim 27 wherein the anchor mechanism comprises a member made from nitinol sheet, defining a length and formed to have at least a single tine at one end of its length and an inner end capable of receiving the actuation key at the other end of its length.

30. The device of claim 27 wherein the anchor mechanism comprises a member made from nitinol tubing which is cut to define at least a single tine at one end.

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

a. an anchor sleeve having a chamber defining a longitudinal axis and at least a single port;

b. an anchor mechanism movably loaded into the chamber, the anchor mechanism capable of moving between a restrained first configuration and an unrestrained second configuration, the anchor mechanism having;

i. at least a single loop capable of extending from the port,

(1) the loop is capable of repeatedly moving between the first configuration and the second configuration,

(2) the loop having a trained shape when in the second configuration, and

ii. biasing means to move the anchor mechanism into the second configuration; and

iii. a key sized to fit into the anchor sleeve to contact the anchor mechanism;

whereby inserting the key into the anchor sleeve moves the anchor mechanism from the second configuration to the first configuration causing the loop to enter the chamber through the port.

32. The device of claim 31 wherein the loop is made of a nitinol alloy.

33. The device of claim 32 wherein the nitinol anchor mechanism is processed to exhibit superelasticity at a temperature below human body temperature.

34. The device of claim 31 wherein the anchor mechanism is made of stainless steel.

35. The device of claim 31 wherein the loop is loaded into the chamber at an axis parallel with the longitudinal axis of the anchor sleeve.

36. The device of claim 31 wherein the loop is loaded into the chamber at an angle perpendicular to the longitudinal axis of the anchor sleeve.

37. The device of claim 31 wherein the biasing means is a spring attached to the anchor mechanism.

38. The device of claim 31 wherein the biasing means is a spring integrally attached to the anchor mechanism.

39. The device of claim 31 wherein the biasing means is a spring separate from the anchor mechanism.

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

a. an inner sheath defining an outer dimension and an outer sheath defining an inner dimension, the outer dimension of the inner sheath sized to slidably fit inside the inner dimension of the outer sheath, the outer sheath defining a sliding end, the sliding end movable along the inner sheath; and

b. a braid defining a length and a width, the braid attached at a first point to the sliding end of the outer sheath and at a second point to the inner sheath, the braid capable of moving between an elongated configuration having a greater length and a lesser width and a shortened configuration having an inverse relationship between length and width;

wherein when the sliding end of the outer sheath is moved the full distance of its travel from the point of braid attachment on the inner sheath, the braid assumes the elongated configuration and the device can be introduced or removed from the patient, and when the sliding end of the outer sheath is moved in a direction toward the point of braid attachment on the inner sheath, the braid moves toward the shortened configuration and the braid defines a widest circumference.

41. The device of claim 40 wherein the braid is coated with an elastomeric coating.

42. The device of claim 43 wherein the braid is made of nitinol.

43. The device of claim 40 wherein the braid is made of stainless steel.

44. The device of claim 42 wherein the nitinol braid is processed to exhibit superelasticity at a temperature below human body temperature.

45. The device of claim 44 wherein the braid is processed to be symmetrical against a longitudinal axis of the inner sheath and outer sheath when the braid is in the shortened configuration.

46. The device of claim 44 wherein the braid is processed to be asymmetrical against a longitudinal axis of the inner sheath and outer sheath when the braid is in the shortened configuration.

47. The device of claim 46 wherein the widest circumference of the braid is processed to extend around the longitudinal axis of the inner sheath at an approximately 60 degree/30 degree angle when the braid is in the shortened configuration.

48. The device of claim 46 wherein the widest circumference of the braid is processed to extend around the longitudinal axis of the inner sheath at an approximately 45 degree/45 degree angle when the braid is in the shortened configuration.