Temporary retention device

• US 9,884,168 B2
• Filed: 11/19/2015
• Issued: 02/06/2018
• 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:
  US14/946,452
• Publication Number:
  US 20160074629A1
• Time in Patent Office: 810 Days
• 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 method for securing a catheter relative to a skin opening that is occupied by the catheter, the method comprising:

inserting a distal portion of a catheter through an opening in a skin layer and into a targeted body site;

advancing first and second flexible anchors of a catheter anchor device through the same opening in the skin layer and into a subcutaneous region under the skin layer, wherein the catheter anchor device comprises;

a catheter retainer body including a longitudinal channel configured to releasably engage with an outer surface of an external portion of the catheter; and

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

a longitudinal extender apparatus secured to the catheter retainer body, and said 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 the skin layer; and

maintaining the external portion of the catheter in securement with the catheter retainer body while the non-sharp tips of the first and second flexible anchors reside within the subcutaneous region under the skin layer and while the distal portion of the catheter extends into the targeted body site.

2. The method of claim 1, further comprising withdrawing the first and second flexible anchors of the catheter anchor device from the subcutaneous region and out through the same opening in the skin layer.

3. The method of claim 2, further comprising adjusting the first and second flexible anchors of the catheter anchor device to a withdrawal position that is different from the subcutaneously deployed orientation during withdrawal from the subcutaneous region and out through the same opening in the skin layer.

4. The method of claim 1, 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 the opening in the skin layer and the subcutaneously deployed position in which the first and second flexible anchors extend outwardly away from one another in generally opposite directions.

5. The method of claim 1, wherein when the first and second flexible anchors are positioned in the subcutaneously deployed position, a space between the tips of the first and second flexible anchors is greater than a space between the tips of the first flexible and second flexible anchors when the first and second flexible anchors are positioned in the first position.

6. The method of claim 1, further comprising maintaining the first and second flexible anchors in the subcutaneously deployed position using a locking system of the catheter anchor device.

7. The method of claim 1, further comprising disposing the catheter anchor device on an exterior of the skin layer proximate to the opening in the skin layer.

8. The method of claim 7, wherein the anchor device is disposed on the skin layer proximate to an underlying vessel, and wherein the distal portion of the catheter is inserted through the opening in the skin layer and into the underlying vessel.

9. The method of claim 1, wherein the first and second flexible anchors comprise a material selected from the group consisting of stainless steel and nitinol.

10. The method of claim 1, wherein the anchor assembly is movable relative to the catheter retainer body.

11. The method of claim 1, wherein the longitudinal extender apparatus comprises a rod.

12. The method of claim 11, further comprising actuating the rod relative to the catheter retainer body so as to flexibly adjust the first and second flexible anchors from the first position to the subcutaneously deployed position.

13. The method of claim 1, wherein the non-sharp tip of each of the first and second flexible anchors comprises a dull or rounded tip.

14. The method of claim 1, wherein the first flexible anchor includes a first lengthwise convexly flexible portion extending toward the tip of the first flexible anchor such that the first lengthwise convexly flexible portion bows toward the catheter retainer body.

15. The method of claim 14, 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.

16. The method of claim 15, 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.

17. The method of claim 1, wherein each of the first and second flexible anchors is deployable from a corresponding port along an exterior of the catheter anchor device.