Temporary retention device

• US 9,227,040 B2
• Filed: 03/19/2014
• Issued: 01/05/2016
• 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
• Application Number:
  US14/219,415
• Publication Number:
  US 20140207147A1
• Time in Patent Office: 657 Days
• US Class Current: 1/1
• 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 using an anchor device to subcutaneously anchor a catheter to a patient, comprising:

inserting a catheter through an opening in a skin layer and into a targeted body lumen;

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

a catheter retainer body including a catheter engagement portion extending in a longitudinal direction, the catheter engagement portion being configured to releasably engage with an outer surface of the catheter, a longitudinal extension apparatus that is secured to the catheter retainer body, that is spaced apart from the catheter engagement portion, and that extends in a direction that is generally parallel to the longitudinal direction of the catheter engagement portion, wherein the first and second flexible anchors are configured to extending outwardly away from a distal region of the longitudinal extension apparatus, wherein a free end of the first flexible anchor terminates at a non-sharp tip, and wherein a free end of the second flexible anchor terminates at a non-sharp tip;

deploying the first and second flexible anchors in the subcutaneous region under the skin layer such that the free end of the first flexible anchor extends generally oppositely away from the free end of the second flexible anchor and such that the first and second flexible anchors abut an underside of the skin layer,

wherein the catheter retainer body engages with the outer surface of the catheter to anchor the catheter relative to the opening in the skin layer.

2. The method of claim 1, wherein said advancing the first and second flexible anchors through the same opening in the skin layer includes advancing at least the distal region of the longitudinal extension apparatus through the same opening in the skin layer.

3. The method of claim 2, wherein the first and second flexible anchors are flexible relative to the longitudinal extension apparatus such that the first and second flexible anchors are configured to repeatedly move between a first configuration in which the first and second flexible anchors are positioned for insertion through the same opening in the skin layer and a second configuration in which the first and second flexible anchors extend outwardly away from one another in generally opposite directions.

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

5. The method of claim 1, wherein the free end of the first flexible anchor comprises a dull or rounded tip, and wherein the free end of the second flexible anchor comprises a dull or rounded tip.

6. The method of claim 1, further comprising moving the longitudinal extension apparatus and the first and second flexible anchors relative to the catheter retainer body.

7. The method of claim 1, wherein the longitudinal extension apparatus comprises an elongate shaft.

8. The method of claim 7, further comprising actuating the shaft of the longitudinal extension apparatus for movement relative to the catheter retainer body.

9. The method of claim 1, wherein the longitudinal extension apparatus is housed inside the catheter retainer body.

10. The method of claim 1, wherein said deploying the first and second flexible anchors in the subcutaneous region comprises abutting a first convexly bowed portion with the underside of the skin layer, the first convexly bowed portion extending lengthwise toward the free end of the first flexible anchor such that the first convexly bowed portion faces proximally toward the catheter retainer body.

11. The method of claim 10, wherein said deploying the first and second flexible anchors in the subcutaneous region comprises abutting a second convexly bowed portion with the underside of the skin layer, the second convexly bowed portion extending lengthwise toward the free end of the second flexible anchor such that the second convexly bowed portion faces proximally toward the catheter retainer body.

12. A method for using an anchor device to subcutaneously anchor a medical device to a patient, comprising:

inserting a medical device through an opening in a skin layer so that a proximal portion of the medical device resides external to the skin layer and a distal portion of the medical device resides in a targeted portion of a body;

deploying first and second flexible anchors of an anchor device through the same opening in the skin layer and into a subcutaneous region adjacent to and under the skin layer such that a free end of the first flexible anchor extends generally oppositely away from a free end of the second flexible anchor and such that the first and second flexible anchors abut an underside of the skin layer, wherein the anchor device comprises;

a retainer body comprising an elongate surface configured to releasably engage with an outer surface of the medical device; and

an anchor mechanism contacting the retainer body and being spaced apart from the elongate surface of the retainer body, the anchor mechanism 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 at least a portion of the longitudinal extender apparatus is laterally offset from the channel of the retainer body.

13. The method of claim 12, wherein said deploying the first and second flexible anchors through the same opening in the skin layer includes advancing at least the distal region of the longitudinal extender apparatus through the same opening in the skin layer.

14. The method of claim 13, wherein the first and second flexible anchors are flexible relative to the longitudinal extender apparatus such that the first and second flexible anchors are configured to repeatedly move between a first configuration in which the first and second flexible anchors are positioned for insertion through the same opening in the skin layer and a second configuration in which the first and second flexible anchors extend outwardly away from one another in generally opposite directions.

15. The method of claim 12, wherein the first and second flexible anchors comprise a material selected from the group consisting of stainless steel and nitinol.

16. The method of claim 12, further comprising moving the longitudinal extender apparatus and the first and second flexible anchors relative to the retainer body.

17. The method of claim 12, wherein the longitudinal extender apparatus comprises a rod.

18. The method of claim 12, wherein the longitudinal extension apparatus is housed inside the retainer body.

19. The method of claim 12, wherein the medical device comprises a catheter.

20. The method of claim 12, wherein said deploying the first and second flexible anchors comprises:

abutting a first convexly bowed portion with the underside of the skin layer, the first convexly bowed portion extending lengthwise toward the free end of the first flexible anchor such that the first convexly bowed portion faces proximally toward the catheter retainer body, and abutting a second convexly bowed portion with the underside of the skin layer, the second convexly bowed portion extending lengthwise toward the free end of the second flexible anchor such that the second convexly bowed portion faces proximally toward the catheter retainer body.