Subcutaneous catheter retainer

• US 20070232997A1
• Filed: 03/30/2007
• Published: 10/04/2007
• Est. Priority Date: 03/31/2006
• Status: Active Grant

• Current Assignee: Stealth Therapeutics, Inc.
• Original Assignee: Stealth Therapeutics, Inc.
• Inventors: Glenn, Bradley J.
• Granted Patent: US 9,138,563 B2
• Time in Patent Office: Days
• US Class Current: 604/103.30
• CPC Class Codes: A61B 17/3421 Cannulas
• 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 retainer is provided which can be affixed to a medical tube, such as a catheter, or formed with the tube. The retainer has a base portion which is fixed to the tube. An expandable width portion is coupled to the base portion. This expandable width portion can transition between a collapsed configuration and an expanded configuration, with the expanded configuration wider than the base portion and the collapsed configuration narrower than the expanded configuration. This retainer is located on a portion of the tube which is subcutaneous but near the skin. After the tube is positioned where desired, the retainer is transitioned from the collapsed configuration to the expanded configuration. The retainer then resists removal of the tube, due to the expanded width of the retainer and its location beneath the skin. The tube fitted with the retainer can be a PICC line or other form of medical tube.

Claims

1. A subcutaneous medical tube retainer, comprising in combination:

a base portion adapted to be attached to a subcutaneous port of a medical tube;

an expandable width portion coupled to said base portion;

said expandable width portion having at least two configurations including an expanded configuration with a width greater than said base portion, and a collapsed configuration with a width less than said width of said expanded configuration; and

said expandable width portion adapted to transition between said collapsed configuration and said expanded configuration.

2. The retainer of claim 1 wherein said base portion includes a fixed sleeve adapted to at least partially surround the subcutaneous port of the medical tube, said fixed sleeve adapted to be fixed to the medical tube.

3. The retainer of claim 2 wherein said fixed sleeve is adapted to be removably attached to said medical tube.

4. The retainer of claim 3 wherein said fixed sleeve is cylindrical in form with an interior surface which is adapted to receive the subcutaneous port of the medical tube passing therethrough, said inside surface including teeth thereon adapted to grip the medical tube, said retainer also including a sliding sleeve with said expandable width portion interposed between said sliding sleeve and said fixed sleeve, said sliding sleeve having a hollow cylindrical bore passing therethrough, said bore adapted to receive a portion of the medical tube extending therethrough;

and

wherein said expandable width portion includes wings coupled to both said fixed sleeve and said sliding sleeve with said wings including at least two substantially rigid links hinged together and hinged to said fixed sleeve and said sliding sleeve, with said links extending laterally away from a centerline of said fixed sleeve and said sliding sleeve at portions of said links hinged together, such that said wings exhibit a greater width when said sliding sleeve is slid toward said fixed sleeve than when said sliding sleeve is slid away from said fixed sleeve.

5. The retainer of claim 2 wherein said fixed sleeve is permanently affixed to said medical tube.

6. The retainer of claim 1 wherein said expandable width portion includes at least one wing, said wing including at least two links, said links adapted to be pivoted relative to said base and relative to each other with said links remaining attached to each other.

7. The retainer of claim 6 wherein said at least one wing includes a fixed end and a free end, said fixed end pivotably coupled to said base portion and said free end adapted to move relative to said fixed end, one of said links having said fixed end of said wing and one of said links having said free end of said wing, portions of said links spaced from said fixed end and said free end hingedly coupled together, said fixed end and said free end of said wing each adapted to remain adjacent the medical tube to which said base portion is attached, with portions of said links hingedly attached together transitioning from a first position adjacent the medical tube when said expandable width portion is in said collapsed configuration to a second position spaced from the medical tube when said expandable width portion is in said expanded configuration.

8. The retainer of claim 7 wherein said expandable width portion includes a sliding sleeve pivotably coupled to said free end of said wings, said sliding sleeve having a hollow bore passing therethrough adapted to receive a portion of the medical tube passing therethrough, said sliding sleeve adapted to slide along the medical tube when the medical tube is routed through said bore in said sliding sleeve, said expandable width portion including a fixed sleeve coupled to said fixed end of said wing, said fixed sleeve adapted to be affixed to the medical tube, said wing interposed between said sliding sleeve and said fixed sleeve with one of said at least two links hingedly coupled to said sliding sleeve and one of said at least two links hingedly coupled to said fixed sleeve.

9. The retainer of claim 1 wherein said base portion includes a chamber adapted to substantially contain said expandable width portion when said expandable width portion is in said collapsed configuration.

10. The retainer of claim 9 wherein said base portion includes at least one slot passing laterally into said chamber, said expandable width portion adapted to extend partially out of said at least one slot when said expandable width portion is in said expanded configuration.

11. The retainer of claim 10 wherein said expandable width portion includes a shuttle located within said chamber of said base portion, said shuttle including a pair of limbs hingedly attached together, one of said limbs adapted to rotate and extend out of said at least one slot in said chamber, with the other of said pair of limbs adapted to pass through a second slot opposite said at least one slot passing into said chamber, with said slots located on opposite sides of said base portion, said limbs adapted to rotate relative to each other and extend through said slots and out of said chamber when said expandable width portion transitions from said collapsed configuration to said expanded configuration.

12. The retainer of claim 10 wherein said expandable width portion includes an expansion loop having at least four segments hingedly coupled to each other to form a complete circuit, said expansion loop having a narrow form contained primarily within said chamber and corresponding with said collapsed configuration of said expandable width portion, and a wide form corresponding with said expanded configuration of said expandable width portion, said wide form of said expansion loop including segments of said expansion loop extending out of said at least one slot in said chamber.

13. The retainer of claim 9 wherein said chamber is formed with the medical tube as a unitary mass of material.

14. The retainer of claim 1 wherein said base portion includes a pivot adapted to be affixed to a medical tube, said expandable width portion including an elongate leg coupled to said pivot and adapted to rotate about said pivot from a first position corresponding with said collapsed configuration of said expandable width portion and a second position corresponding with said expanded configuration of said expandable width portion, said second position extending further laterally away from said pivot than said first position.

15. The retainer of claim 14 wherein said pivot is permanently attached to the medical tube.

16. The retainer of claim 14 wherein said pivot is formed with the medical tube as a unitary mass of material, and wherein said pivot is in the form of a post extending substantially perpendicularly from a long axis of the medical tube.

17. A skin penetrating medical tube featuring a subcutaneous retainer, the medical tube comprising in combination:

an elongate conduit surrounded by a wall and extending between an access end and a discharge end;

said access end adapted to receive a substance to be delivered to a patient;

said discharge end adapted to be embedded within a body lumen or other subcutaneous delivery site;

a retainer coupled to said wall between said access end and said discharge end; and

said retainer including an expandable width portion adapted to transition between two configurations including an expanded configuration with a width greater than a width of said wall around said conduit, and a collapsed configuration with a width less than said width of said expanded configuration.

18. The medical tube of claim 17 wherein said medical tube is adapted to be flexible between said access end and said discharge end with said conduit surrounded by said wall of substantially constant thickness, said medical tube including an interface adjacent said access end, said interface adapted to be removably coupleable to other substance delivery devices.

19. The medical tube of claim 17 wherein said retainer includes a base portion adapted to be attached to a subcutaneous portion of said wall, said base portion including a fixed sleeve adapted to at least partially surround said wall.

20. The medical tube of claim 17 wherein said retainer includes a base portion, said base portion including a chamber adapted to contain most of said expandable width portion when said expandable width portion is in said collapsed configuration.

21. The medical tube of claim 17 wherein said retainer includes a base portion, said base portion including a pivot adapted to be affixed to said wall, said expandable width portion including an elongate leg coupled to said pivot and adapted to rotate about said pivot between a first position corresponding with said collapsed configuration of said expandable width portion and a second position corresponding with said expanded configuration of said expandable width portion, said second position extending further laterally away from said pivot than said first position.

22. The medical tube of claim 21 wherein said leg is substantially straight between a first end and a second end.

23. The medical tube of claim 21 wherein said leg has a bend between said first end and said second end.

24. The medical tube of claim 21 wherein a pair of ramps extend from said wall on a side of said wall common with a side from which said pivot extends from said wall, said pair of ramps aligned in a common plane with said pivot and each other, said ramps having a sloping surface thereon such that a gradual transition is provided between said wall on sides of said ramps closer to ends of said medical tube than to said leg, such that a gradual transition in wall-thickness is provided adjacent said leg when said leg is in a position corresponding with said collapsed configuration for said expandable width portion.

25. A method for retaining a skin penetrating medical tube at an implant site, the method including the steps of:

providing a retainer including a base portion adapted to be attached to a subcutaneous port of a medical tube;

an expandable width portion coupled to the base portion; and

the expandable width portion having at least two configurations including an expanded configuration with a width greater than the base portion, and a collapsed configuration with a width less than the width of the expanded configuration;

attaching the retainer to the medical tube;

implanting the medical tube with the retainer below the skin; and

transitioning the expandable width portion of the retainer from the collapsed configuration to the expanded configuration with the expandable width portion below the skin.

26. The method of claim 25 wherein said implanting step includes the steps of:

forming an opening in the skin;

forming an opening in a body lumen; and

routing the medical tube through the opening in the skin and the opening in the lumen with the medical tube having a discharge end located inside the body lumen and an access end opposite the discharge end located outside of the body.

27. The method of claim 25 wherein said transitioning step includes the steps of:

configuring the base portion of the retainer to include a fixed sleeve adapted to at least partially surround the subcutaneous port of the medical tube and be coupled to the medical tube;

forming the retainer to include a sliding sleeve having a bore with a portion of the medical tube routed through the bore, the sliding sleeve adapted to slide along the medical tube, and with an expandable width wing interposed between the sliding sleeve and the fixed sleeve; and

sliding the sliding sleeve toward the fixed sleeve to transition the wing from a narrower form to a wider form, such that the expandable width portion is transitioned from the collapsed configuration to the expanded configuration.

28. The method of claim 25 wherein said transitioning step includes the steps of:

providing a pivot adapted to be affixed to the medical tube;

the expandable width portion including an elongate leg coupled to the pivot and adapted to rotate about the pivot between a first position and a second position, with the second position wider than the first position in a direction lateral to a length of the medical tube; and

rotating the leg about the pivot.

29. The method of claim 25 wherein said transitioning step includes the steps of:

providing a chamber within the base portion, the chamber adapted to primarily contain the expandable width portion when in the collapsed configuration, the chamber including at least one slot passing into the chamber through which at least a portion of the expandable width portion can extend when the expandable width portion transitions to the expanded configuration; and

adjusting the expandable width portion within the chamber such that at least a portion of the expandable width portion extends laterally out of the at least one slot of the chamber, so that the expandable width portion expands to a width greater than the base portion of the retainer.

30. The method of claim 25 wherein said attaching step includes the step of mechanically affixing the retainer to the medical tube.

31. The method of claim 25 wherein said attaching step includes the step of bonding the retainer to the medical tube.

32. The method of claim 25 wherein said attaching step includes the step of forming the retainer along with the medical tube during a medical tube forming process.