Temporary retention device

• US 8,715,295 B2
• Filed: 07/18/2012
• Issued: 05/06/2014
• Est. Priority Date: 09/20/2002
• Status: Expired due to Term

• 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:
  US13/552,081
• Publication Number:
  US 20120283644A1
• Time in Patent Office: 657 Days
• Field of Search: 600/184, 600/217, 604/93.01, 60416401-16408, 604/174, 606/108, 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
• 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 coupling with a catheter device and for subcutaneously anchoring the catheter device to a patient, comprising:

a catheter retainer body including a catheter-receiving channel extending in a longitudinal direction to a distal opening, the catheter-receiving channel being configured to releasably engage with an outer surface of a removably coupled catheter device; and

a subcutaneous anchor assembly that is spaced apart from the catheter-receiving channel and that includes;

a longitudinal extender assembly secured to the catheter retainer body and extending in a direction that is generally parallel to the longitudinal direction of the catheter-receiving channel, and

first and second flexible anchors extending outwardly away from a distal region of the longitudinal extender assembly, wherein when the removably coupled catheter device is positioned through a skin puncture, the first and second flexible anchors are contemporaneously insertable through the same skin puncture to subcutaneously deploy the first and second flexible anchors for tissue engagement along an underside of a skin layer so that a free end of the first flexible anchor extends generally oppositely away from a free end of the second flexible anchor,

wherein the free end of the first flexible anchor terminates at a non-sharp tip, and wherein the free end of the second flexible anchor terminates at a non-sharp tip.

2. The device of claim 1, wherein the first and second flexible anchors are capable of repeatedly moving between a first configuration in which the first and second flexible anchors are positioned for insertion through the same skin puncture and a second configuration in which the first and second flexible anchors extend outwardly away from one another in generally opposite directions.

3. The device of claim 1, wherein the first and second flexible anchors comprise a superelastic material.

4. The device of claim 1, wherein the non-sharp tip at the free end of the first flexible anchor comprises a dull or rounded tip, and wherein the non-sharp tip at the free end of the second flexible anchor comprises a dull or rounded tip.

5. The device of claim 1, wherein the subcutaneous anchor assembly is movable relative to the catheter retainer body.

6. The device of claim 1, wherein the longitudinal extender assembly comprises a rod.

7. The device of claim 6, wherein the rod of the longitudinal extender assembly is an actuator rod that is adjustable relative to the catheter retainer body.

8. The device of claim 1, wherein the longitudinal extender assembly is housed inside the catheter retainer body.

9. The device of claim 1, wherein the first anchor includes a first convexly bowed portion extending lengthwise toward the free end of the first anchor such that the first convexly bowed portion faces proximally toward the catheter retainer body, and wherein the second anchor includes a second convexly bowed portion extending lengthwise toward the free end of the second anchor such that the second convexly bowed portion faces proximally toward the catheter retainer body.

10. The device of claim 9, wherein the first convexly bowed portion of the first flexible anchor and the second convexly bowed portion of the second flexible anchor face toward the underside of the skin layer when the first and second flexible anchors are subcutaneously deployed.

11. A device for coupling to a medical device and for subcutaneously anchoring the medical device to a patient, comprising:

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

an anchor mechanism contacting the retainer body and being spaced apart from the channel of the retainer body, the anchor mechanism including;

a longitudinal extender apparatus secured to the catheter retainer body, and first and second flexible anchors extending outwardly away from a distal region of the longitudinal extender apparatus, each of the first and second flexible anchors terminating at a non-sharp tip, wherein the first and second flexible anchors are movable from a first position to a subcutaneously deployed position in which the first and second flexible anchors extend outwardly away from one another in generally opposite directions and are configured to engage tissue along an underside of a skin layer,

wherein at least a portion of the longitudinal extender apparatus is laterally offset from the channel of the retainer body.

12. The device of claim 11, wherein the first and second flexible anchors are capable of repeatedly moving between the first position in which the first and second flexible anchors are arranged for insertion through a skin puncture and the subcutaneously deployed position in which the first and second flexible anchors extend outwardly away from one another in generally opposite directions.

13. The device of claim 12, wherein when the first and second flexible anchors are positioned in the subcutaneously deployed position, a space between the free ends of the first flexible anchor is greater than the space between the free ends of the first flexible anchor when the first and second flexible anchors are positioned in the first position.

14. The device of claim 11, wherein when the medical device is releasably engaged by the retainer body and inserted through a skin puncture, the first and second flexible anchors are insertable through the same skin puncture to subcutaneously deploy the first and second flexible anchors for tissue engagement along the underside of the skin layer.

15. The device of claim 11, wherein the first and second flexible anchors comprise a material selected from the group consisting of stainless steel and nitinol.

16. The device of claim 11, wherein the anchor mechanism is movable relative to the retainer body.

17. The device of claim 11, wherein the longitudinal extender apparatus comprises a rod.

18. The device of claim 11, wherein the non-sharp tip of each of the first and second flexible anchors comprises a dull or rounded tip.

19. The device of claim 11, wherein the first flexible anchor includes a first lengthwise convexly flexible portion extending toward the free end of the first flexible anchor such that the first lengthwise convexly flexible portion bows toward the retainer body, and wherein the second flexible anchor includes a second lengthwise convexly flexible portion extending toward the free end of the second flexible anchor such that the second lengthwise convexly flexible portion bows toward the retainer body.

20. The device of claim 19, wherein the first lengthwise convexly flexible portion of the first flexible anchor and the second lengthwise convexly flexible portion of the second flexible anchor face toward the underside of the skin layer when the first and second flexible anchors are subcutaneously deployed.