Device with open cutout design for securement and position verification of medical catheters

• US 10,293,141 B2
• Filed: 07/02/2018
• Issued: 05/21/2019
• Est. Priority Date: 07/03/2017
• Status: Active Grant

• Current Assignee: Cathaid, Inc.
• Original Assignee: Cathaid, Inc.
• Inventors: Hsu, George, Zheng, Xiaoyu Alan
• Primary Examiner(s): Mehta, Bhisma
• Assistant Examiner(s): Ponton, James D
• Application Number:
  US16/025,318
• Publication Number:
  US 20190001101A1
• Time in Patent Office: 323 Days
• CPC Class Codes: A61M 2025/0246 fixed on the skin having a cover for covering the holding means
• CPC Class Codes: A61M 2025/0266 using pads, patches, tapes or the like
• CPC Class Codes: A61M 2025/0273 having slits to place the pad around a catheter puncturing site
• CPC Class Codes: A61M 2205/0205 Materials having antiseptic or antimicrobial properties, e.g. silver compounds, rubber with sterilising agent
• CPC Class Codes: A61M 2205/33 Controlling, regulating or measuring
• CPC Class Codes: A61M 2205/583 by visual feedback
• CPC Class Codes: A61M 25/02 Holding devices, e.g. on the body

Abstract

A device for securing and monitoring movement of a catheter includes a film having an adhesive disposed on a body-facing surface for securing the film to a body. The device also includes a base mounted on the film, the base comprising a first portion of a guide channel for receiving the catheter. A cover is coupled to the base via a hinge, the cover comprising a second portion of the guide channel, the cover further comprising a rounded portion extending from a distal end of the cover, wherein in the closed configuration, the catheter is completely enclosed by the rounded portion and the first and second portions of the guide channel. The device also includes a positional shift indicator fixedly attached to the catheter and configured to indicate positional shifts by the catheter within the guide channel.

Claims

1. A device for securing and monitoring movement of a catheter, comprising:

a film having an adhesive disposed on a body-facing surface of the film for securing the film to a body;

a base mounted on the film, the base comprising a first portion of a guide channel for receiving the catheter, the base further comprising a tab member protruding from a side of the base;

a hinge coupled to the base, the hinge extending along a longitudinal direction of the base;

a cover coupled to the base via the hinge such that the cover is operable to pivot about the hinge from an open configuration to a closed configuration, the cover comprising a second portion of the guide channel, the cover further comprising a rounded portion extending from a distal end of the cover, wherein in the closed configuration, the catheter is completely enclosed by the rounded portion and the first and second portions of the guide channel;

wherein in the closed configuration, the cover and the base form a housing for securing the catheter, wherein an adhesive is disposed on the first and second portions of the guide channel for restricting movement of the catheter, wherein the cover further comprises a positional shift indicator fixedly attached to the catheter and configured to indicate positional shifts by the catheter within the guide channel, wherein the positional shift indicator comprises a plurality of segments arranged in a direction perpendicular to a longitudinal direction of the cover, wherein a center segment of the plurality of segments of the positional shift indicator is disposed on the second portion of the guide channel in the cover, and wherein the second portion of the guide channel in the cover includes a region wider than a remainder of the second portion of the guide channel in the cover, wherein the center segment is disposed in the region.

2. The device of claim 1, wherein the cover and the base are constructed of a clear medical grade silicone material.

3. The device of claim 1, wherein the positional shift indicator fixedly attached to the catheter is viewable from a top view through a top surface of the cover.

4. The device of claim 1, wherein the film includes a cutout portion extending from an edge of the film to a central portion of the film.

5. The device of claim 4, wherein the first portion of the guide channel in the base includes a notch at a distal end of the first portion of the guide channel for insertion of the catheter into the body, wherein the notch is disposed over the cutout portion of the film.

6. The device of claim 4, wherein the cover further comprises a second film having an adhesive disposed on a body-facing surface of the second film for securing the second film to the body, the second film being attached to and extending from the rounded portion of the cover, wherein in the closed configuration, the second film is disposed over the cutout portion to form a complete seal.

7. The device of claim 1, further comprising a recess implemented on a surface of one of the base or the cover for placement of a biomedical sensor.

8. The device of claim 1, wherein an adhesive is disposed on a surface of the cover and on a surface of the base that come into contact with one another in the closed configuration.

9. A method for securing and monitoring movement of a catheter utilizing a device comprising a film, a base, and a cover coupled to the base via a hinge, the method comprising:

attaching the film to a body, the film having an adhesive disposed on a body-facing surface of the film for securing the film to the body;

inserting the catheter at a catheter entry point into the body and placing the catheter in a first portion of a guide channel in the base for receiving the catheter, the base further comprising a tab member protruding from a side of the base;

pivoting the cover coupled to the base via the hinge such that the cover is placed into a closed configuration with respect to the base, the cover comprising a second portion of the guide channel, the cover further comprising a rounded portion extending from a distal end of the cover, wherein in the closed configuration, the catheter is completely enclosed by the rounded portion and the first and second portions of the guide channel;

wherein in the closed configuration, the cover and the base form a housing for securing the catheter, wherein an adhesive is disposed on the first and second portions of the guide channel for restricting movement of the catheter, wherein the cover further comprises a positional shift indicator fixedly attached to the catheter and configured to indicate positional shifts by the catheter within the guide channel, wherein the positional shift indicator comprises a plurality of segments arranged in a direction perpendicular to a longitudinal direction of the cover, wherein a center segment of the plurality of segments of the positional shift indicator is disposed on the second portion of the guide channel in the cover, and wherein the second portion of the guide channel in the cover includes a region wider than a remainder of the second portion of the guide channel in the cover, wherein the center segment is disposed in the region.

10. The method of claim 9, wherein the step of pivoting the cover coupled to the base via the hinge such that the cover is placed into a closed configuration with respect to the base is performed while applying force on the tab member.

11. The method of claim 9, wherein the film includes a cutout portion extending from an edge of the film to a central portion of the film.

12. The method of claim 11, wherein the first portion of the guide channel in the base includes a notch at a distal end of the first portion of the guide channel for insertion of the catheter into the body, wherein the notch is disposed over the cutout portion of the film.

13. The method of claim 11, further comprising attaching a second film over the cutout portion to form a complete seal, where the second film is attached to and extends from the rounded portion of the cover, the second film having an adhesive disposed on a body-facing surface of the second film for securing the second film to the body.

14. The method of claim 9, further comprising:

while the device is in the closed configuration, monitoring for a positional shift of any of the plurality of segments of the positional shift indicator.

15. A device for securing and monitoring movement of a catheter, comprising:

an oval-shaped film having an adhesive disposed on a body-facing surface of the film for securing the film to a body, the film having a cutout portion extending from an edge of the film to a central portion of the film;

a base having tapered sides, the base mounted on the film, the base comprising a first portion of a guide channel for receiving the catheter, the base further comprising a rectangular tab member protruding from a side of the base;

a hinge coupled to the base, the hinge extending along a longitudinal direction of the base;

a cover having tapered sides, the cover coupled to the base via the hinge such that the cover is operable to pivot about the hinge from an open configuration to a closed configuration, the cover comprising a second portion of the guide channel, the cover further comprising a semi-circular member extending from a distal end of the cover, wherein in the closed configuration, the catheter is completely enclosed by the semi-circular member and the first and second portions of the guide channel;

wherein in the closed configuration, the cover and the base form a housing for securing the catheter, wherein an adhesive is disposed on the first and second portions of the guide channel for restricting movement of the catheter, wherein the cover further comprises a positional shift indicator fixedly attached to the catheter and configured to indicate positional shifts by the catheter within the guide channel, wherein the positional shift indicator comprises a plurality of segments arranged in a direction perpendicular to a longitudinal direction of the cover.

16. The device of claim 15, wherein a portion of the cutout portion located in the central portion of the film extends under the base.

17. The device of claim 15, wherein the cover further comprises a second film having an adhesive disposed on a body-facing surface of the second film for securing the second film to the body, the second film being attached to and extending from the semi-circular member of the cover, wherein in the closed configuration, the second film is disposed over the cutout portion to form a complete seal.

18. The device of claim 15, wherein the base further comprises stabilizers, wherein each of the stabilizers is located on one of the tapered sides of the base.