Catheter anchor and system/method regarding same

• US 20080275401A1
• Filed: 05/01/2007
• Published: 11/06/2008
• Est. Priority Date: 05/01/2007
• Status: Abandoned Application

• Current Assignee: Medtronic Incorporated (Medtronic Plc)
• Original Assignee: Medtronic Incorporated (Medtronic Plc)
• Inventors: Sage, Shahn S., Kern, Michael
• Application Number:
  US11/799,166
• Publication Number:
  US 20080275401A1
• Time in Patent Office: Days
• US Class Current: 604/175
• CPC Class Codes: A61M 2025/0213 where the catheter is attached by means specifically adapted to a part of the human body
• CPC Class Codes: A61M 2025/028 having a mainly rigid support structure
• CPC Class Codes: A61M 2025/0286 anchored in the skin by suture or other skin penetrating devices
• 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 25/0612 Devices for protecting the needle; Devices to help insertion of the needle, e.g. wings or holders
• CPC Class Codes: A61N 2001/0582 Suture sleeves

Abstract

An anchor for use in an anchor system and method for securing a catheter to tissue includes a flexible body portion that defines one or more openings through which a catheter is positioned when secured to the tissue. For example, the one or more openings may be a channel through the anchor having a diameter that is less than the outer diameter of the catheter.

Claims

1. An anchor system for use in securing a catheter to tissue, the system comprising:

a catheter anchor placement tool comprising an elongate body portion, wherein the elongate body portion comprises a non-flexible outer cylindrical surface located between a first end and a second end of the elongate body portion, and further wherein the elongate body portion defines a lumen through the elongate body portion from the first end to the second end having a diameter that is greater than an outer diameter of the catheter to allow the catheter to pass through the catheter anchor placement tool; and

an anchor comprising a body member formed of a flexible material defining at least one opening through which the catheter is positioned when secured using the anchor, wherein the outer cylindrical surface of the catheter anchor placement tool is configured so as to hold the anchor thereon such that the inner diameter of the at least one opening defined through the anchor is greater than the outer diameter of the catheter when the anchor is positioned on the outer cylindrical surface.

2. The anchor system of claim 1, wherein the body member of the anchor comprises an elongate body member that defines a channel extending through the elongate body member from a first end to a second end thereof, wherein the cross-sectional inner diameter along at least a portion of the length of the channel is less than the outer diameter of the catheter when in a normal state, wherein the outer cylindrical surface of the catheter anchor placement tool has an outer diameter sized to hold the anchor thereon in a flexed state such that the cross-sectional inner diameter of at least a portion of the channel is greater than the outer diameter of the catheter when the anchor is positioned on the outer cylindrical surface.

3. The anchor system of claim 2, wherein the cross-sectional inner diameter along the entire length of the channel is less than the outer diameter of the catheter when in a normal state.

4. The anchor system of claim 1, wherein the anchor further comprises at least one suture eyelet containing element extending from the body member, wherein the at least one suture eyelet containing element defines at least two suture eyelets, each of the at least two suture eyelets being offset from a centerline extending through the anchor to provide at least two separate suture points offset from the centerline for suturing the anchor to tissue.

5. The anchor system of claim 4, wherein each of the at least two suture eyelets lie in a plane that is orthogonal to the centerline extending through the anchor.

6. The anchor system of claim 4, wherein each of the at least two suture eyelets lie in a plane that is parallel to the centerline extending through the anchor.

7. The anchor system of claim 4, wherein the anchor comprises at least one suture eyelet containing element extending from the body member at a position along the length of the body member, wherein the distance along the length of the body member from the position of the at least one suture eyelet containing element to at least one of the first and second ends of the body member is at least 1 cm and is configured for insertion into tissue.

8. The anchor system of claim 4, wherein the body member of the anchor further comprises one or more stability structures positioned between the at least one suture eyelet containing element and at least one of the first end and second end of the body member.

9. The anchor system of claim 4, wherein the anchor comprises at least one suture eyelet containing element extending from the body member at a center region of the body member, wherein the portion of the body member between the position of the at least one suture eyelet containing element and the first end is configured the same as the portion of the body member between the suture eyelet containing element and the second end.

10. The anchor system of claim 2, wherein the elongate body member comprises a slot that extends from an outer surface of the elongate body member to the channel defined thereby, the slot having side edges opposed to each other, wherein the anchor further comprises a pair of wings extending from the elongate body member on opposite sides of the slot, the pair of wings separated from each other by an angle, wherein the wings and the slot cooperate so that when the wings are brought into contact with each other the anchor secures the catheter in the channel, wherein the pair of wings define a first suture eyelet offset from a centerline of the channel when the pair of wings are brought into contact with each other, and further wherein the anchor comprises an additional wing extending from the elongate body member defining an additional suture eyelet offset from the centerline of the channel.

11. The anchor system of claim 1, wherein the body member of the anchor comprises a flexible planar body member lying along a plane when in a normal state, wherein the planar body member defines a plurality of openings therein to receive the outer cylindrical surface of the catheter anchor placement tool when the planar body member is folded upon itself in a flexed state.

12. The anchor system of claim 1, wherein the catheter anchor placement tool comprises a needle device, wherein the needle device comprises a needle shaft comprising the outer cylindrical surface and defining at least a portion of the lumen, wherein the needle shaft terminates in a needle tip for insertion into the body of a patient.

13. The anchor system of claim 1, wherein the catheter anchor placement tool comprises:

a cylindrical portion comprising the outer cylindrical surface and defining at least a portion of the lumen; and

a holding portion coupled to the cylindrical portion and defining a further portion of the lumen continuous with the portion of the lumen defined by the cylindrical portion.

14. An anchor for use in securing a catheter to tissue, the anchor comprising an elongate body member, wherein a channel is defined through the elongate body member from a first end to a second end thereof, wherein the cross-sectional inner diameter along at least a portion of the length of the channel is less than the outer diameter of the catheter when the anchor is in a normal state preventing the insertion of the catheter through the channel, and further wherein the anchor comprises a flexible material that allows the cross-sectional inner diameter along the portion of the length of the channel to be expanded to a cross-sectional inner diameter greater than the outer diameter of the catheter when the anchor is in a flexed state.

15. The anchor of claim 14, wherein the cross-sectional inner diameter along the entire length of the channel is less than the outer diameter of the catheter when in a normal state.

16. The anchor of claim 14, wherein the anchor further comprises at least one suture eyelet containing element extending from the elongate body member, wherein the at least one suture eyelet containing element defines at least two suture eyelets, each of the at least two suture eyelets being offset from a centerline extending through the channel to provide at least two separate suture points offset from the centerline for suturing the anchor to tissue.

17. The anchor of claim 16, wherein each of the at least two suture eyelets lie in a plane that is orthogonal to the centerline extending through the channel.

18. The anchor of claim 16, wherein each of the at least two suture eyelets lie in a plane that is parallel to the centerline extending through the channel.

19. The anchor of claim 16, wherein the anchor comprises a suture eyelet containing element extending from the elongate body member at a position along the length of the elongate body member, wherein the distance along the length of the elongate body member from the position of the at least one suture eyelet containing element to at least one of the first and second ends of the body member is at least 1 cm and is configured for insertion into tissue.

20. The anchor of claim 16, wherein the anchor comprises one or more stability structures positioned between the at least one suture eyelet containing element and at least one of the first and the second ends of the elongate body member.

21. The anchor of claim 16, wherein the anchor comprises at least one suture eyelet containing element extending from the elongate body member at a center region along the length of the elongate body member, wherein the portion of the elongate body member between the position of the at least one suture eyelet containing element and the first end is configured the same as the portion of the elongate body member between the suture eyelet containing element and the second end.

22. An anchor for use in securing a catheter to tissue, the anchor comprising:

an elongate body member, wherein a channel is defined through the elongate body member from a first end to a second end thereof, wherein the elongate body member comprises a slot that extends from an outer surface of the elongate body member to the channel defined thereby, the slot having side edges opposed to each other;

a pair of wings extending from the elongate body member on opposite sides of the slot, the pair of wings separated from each other by an angle, wherein the wings and the slot cooperate so that when the wings are brought into contact with each other the anchor secures the catheter in the channel, wherein the pair of wings define a first suture eyelet offset from a centerline of the channel when the pair of wings are brought into contact with each other; and

an additional wing extending from the elongate body member defining an additional suture eyelet offset from the centerline of the channel.

23. The anchor of claim 22, wherein the pair of wings extend from the elongate body member at a position along the length of the elongate body member, wherein the distance along the length of the elongate body member from the position of the pair of wings to at least one of the first and second ends of the body member is at least 1 cm and is configured for insertion into tissue.

24. The anchor of claim 23, wherein the distance is at least 2 cm.

25. The anchor of claim 22, wherein the pair of wings extend from the elongate body member proximate the first end of the elongate body member, and further wherein the elongate body member comprises one or more stability structures between the pair wings and the second end of the elongate body member.

26. The anchor of claim 22, wherein the pair of wings extend from the elongate body member at a center region between the first end and the second end of the elongate body member, and further wherein the portion of the elongate body member between the pair of wings and the first end is configured the same as the portion of the elongate body member between the pair of wings and the second end.

27. A method of securing a catheter to tissue, wherein the method comprises:

providing an anchor comprising a body member, wherein the body member comprises a flexible material defining at least one opening through the body member;

inserting a non-flexible portion of a catheter anchor placement tool into the at least one opening of the anchor, wherein the anchor is held thereon;

inserting the catheter through a lumen in the catheter placement tool; and

holding the anchor and removing the catheter anchor placement tool so as to position the anchor on the catheter.

28. The method of claim 27, wherein providing the anchor comprises providing an elongate body member defining a channel through the elongate body member from a first end to a second end thereof, wherein the cross-sectional inner diameter along a least a portion of the length of the channel is less than the outer diameter of the catheter in a normal state when apart from the catheter anchor placement tool, wherein inserting the non-flexible portion of the catheter anchor placement tool into the channel of the anchor comprises expanding the cross-sectional inner diameter along at least a portion of the length of the channel to a cross-sectional inner diameter that is greater than the outer diameter of the catheter.

29. The method of claim 28, wherein holding the anchor and removing the catheter anchor placement tool so as to position the anchor on the catheter comprises holding the anchor and removing the catheter anchor placement tool so as to provide a compression fit of the anchor on the catheter as the cross-sectional inner diameter of the channel returns to the normal state.

30. The method of claim 27, wherein holding the anchor and removing the catheter anchor placement tool so as to position the anchor on the catheter further comprises manipulating one or more portions of the anchor to provide a compression fit of the anchor on the catheter.

31. The method of claim 27, wherein providing the anchor further comprises providing at least one suture eyelet containing element extending from the body member, wherein the at least one suture eyelet containing element defines at least two suture eyelets, each of the at least two suture eyelets offset from a centerline extending through the channel, and further wherein the method comprises placing a suture through each of the at least two suture eyelets and tissue to secure the anchor to the tissue.

32. The method of claim 27, wherein the method further comprises:

making an incision in a tissue region; and

inserting a portion of the anchor at least 1 cm into the tissue.

33. The method of claim 32, wherein inserting the portion of the anchor comprises inserting the portion of the anchor at least 2 cm into the tissue.

34. The method of claim 27, wherein inserting a catheter anchor placement tool into the at least one opening comprises loading the anchor onto a needle device, wherein the needle device comprises a needle shaft comprising an outer cylindrical surface and defining at least a portion of the lumen thereof, wherein the needle shaft terminates in a needle tip for insertion into the body of a patient, and further wherein, prior to inserting the catheter through the lumen, the method comprises:

making an incision in a region of the patient; and

inserting the needle device with the anchor loaded thereon through the incision.

35. The method of claim 27, wherein inserting a catheter anchor placement tool into the channel of the anchor comprises loading the anchor onto a cylindrical portion of the catheter anchor placement tool defining at least a portion of the lumen, and further wherein the method comprises:

providing a needle device comprising a needle shaft defining a lumen through the needle and terminating at a needle tip for insertion into the body of a patient;

inserting the needle device into the patient, wherein the catheter is inserted through the lumen in the needle device and positioned in the patient;

removing the needle device from the patient; and

making an incision in the patient proximate the positioned catheter such that the catheter can be inserted into the lumen of the catheter placement tool and the anchor positioned on the catheter at a desired location.