Systems and methods for providing securement and position verification for medical catheters

• US 9,399,117 B2
• Filed: 11/06/2015
• Issued: 07/26/2016
• Est. Priority Date: 11/13/2014
• Status: Active Grant

• Current Assignee: Cathaid, Inc.
• Original Assignee: George Hsu, Xiaoyu Alan Zheng
• Inventors: Hsu, George, Zheng, Xiaoyu Alan
• Primary Examiner(s): Mehta, Bhisma
• Assistant Examiner(s): LEE, BRANDY SCOTT
• Application Number:
  US14/934,249
• Publication Number:
  US 20160136395A1
• Time in Patent Office: 263 Days
• US Class Current: 1/1
• CPC Class Codes: A61M 2025/0008 having visible markings on its surface, i.e. visible to the naked eye, for any purpose, e.g. insertion depth markers, rotational markers or identification of type
• CPC Class Codes: A61M 2025/0056 provided with an antibacterial agent, e.g. by coating, residing in the polymer matrix or releasing an agent out of a reservoir
• CPC Class Codes: A61M 2025/024 having a clip or clamp system
• CPC Class Codes: A61M 2025/0273 having slits to place the pad around a catheter puncturing site
• CPC Class Codes: A61M 25/02 Holding devices, e.g. on the body
• CPC Class Codes: A61M 5/5086 for indicating if defective, used, tampered with or unsterile

Abstract

An antimicrobial, securement, and position verification device for medical catheters is disclosed. A film, medical grade adhesive, and antimicrobial substance disposed on the medical grade adhesive operate in conjunction to secure the device to the patient'"'"'s skin and to prevent infections. The catheter is secured by guide channels in the foundation and securement cover through the use of one or more adhesives impregnated with antimicrobial substances. The device further comprises catheter position alert media and indicators configured to indicate any unintentional positional changes.

Claims

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

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

a securement foundation mounted on the film;

a securement cover; and

a hinge member coupling the securement foundation to the securement cover, wherein when the securement cover and the securement foundation are configured in a closed state via the hinge, the securement cover and the securement foundation form a housing with a guide channel for securing the catheter,

wherein an adhesive is disposed on a surface of the guide channel for restricting movement of the catheter within the housing formed by the securement cover and the securement foundation,

wherein the securement cover further comprises positional shift alert media configured to indicate positional shifts by the catheter relative to the housing,

wherein the position shift alert media comprises a positional indicator embedded in the adhesive disposed on the surface of the guide channel, wherein when the securement cover and the securement foundation are configured in the closed state, the positional indicator is fixedly attached to the catheter via the adhesive,

wherein the securement cover is constructed of a clear medical grade silicone material, and

wherein the positional shift alert media further comprises a plurality of tinted regions in the securement cover, the tinted regions being located at a distal end and at the proximal end of the securement cover, wherein the positional indicator fixedly attached to the catheter is viewable from a top view through a top surface of the securement cover, and wherein the positional indicator fixedly attached to the catheter is initially centrally located relative to the tinted regions.

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

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

a securement foundation mounted on the film;

a securement cover; and

a hinge member coupling the securement foundation to the securement cover, wherein when the securement cover and the securement foundation are configured in a closed state via the hinge, the securement cover and the securement foundation form a housing with a guide channel for securing the catheter,

wherein an adhesive is disposed on a surface of the guide channel for restricting movement of the catheter within the housing formed by the securement cover and the securement foundation,

wherein the securement cover further comprises positional shift alert media configured to indicate positional shifts by the catheter relative to the housing,

wherein the position shift alert media comprises a positional indicator embedded in the adhesive disposed on the surface of the guide channel, wherein when the securement cover and the securement foundation are configured in the closed state, the positional indicator is fixedly attached to the catheter via the adhesive,

wherein the securement cover is constructed of a clear medical grade silicone material, and wherein the positional shift alert media further comprises a plurality of line indicators etched into the securement cover, wherein the positional indicator fixedly attached to the catheter is viewable from a top view through a top surface of the securement cover.

3. The device of claim 2, wherein in the closed state, the securement cover and the securement foundation further comprise a recess at a proximal end of the housing for insertion of the catheter into the body.

4. The device of claim 3, wherein a region in which the recess overlays the film comprises a catheter entry point for insertion of the catheter into the body, wherein the securement foundation is aligned with the catheter entry point such that the catheter protruding from the body enters through the catheter entry point of the film into the recess and enters the guide channel.

5. The device of claim 2, wherein the line indicators are spaced 1 mm apart.

6. A method for securing and monitoring movement by a medical catheter, comprising:

inserting the medical catheter into the body;

threading the medical catheter through a catheter entry point in a film having an adhesive disposed on a body-facing surface, the adhesive having antimicrobial properties;

attaching the film to the body via the adhesive;

placing the catheter in a guide channel formed by a securement foundation and a securement cover, the securement foundation being mounted on the film, and the securement foundation being coupled to the securement cover via a hinge;

placing the securement foundation mounted and the securement cover in a closed state via the hinge to form a housing around the catheter, wherein an adhesive disposed on a surface of the guide channel restricts movement of the catheter within the housing,

wherein the securement cover further comprises positional shift alert media configured to indicate positional shifts by the catheter relative to the housing, wherein the position shift alert media comprises a positional indicator embedded in the adhesive applied to the surface of the guide channel, wherein when the securement cover and the securement foundation are configured in the closed state, the positional indicator is fixedly attached to the catheter via the adhesive, and

wherein the securement cover is constructed of a clear medical grade silicone material, and wherein the positional shift alert media further comprises a plurality of tinted regions in the securement cover, wherein the positional indicator fixedly attached to the catheter is viewable from a top view through a top surface of the securement cover.

7. The method of claim 6, further comprising monitoring movement of the positional indicator relative to the plurality of tinted regions in the securement cover.

8. The method of claim 7, further comprising determining, based on a location of the positional indicator in one of the plurality of tinted regions, a direction of movement by the medical catheter.

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

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

a securement foundation mounted on the film;

a securement cover, wherein both the securement foundation and the securement cover comprise a circular portion and an elongated portion; and

a hinge member coupling the securement foundation to the securement cover, wherein when the securement cover and the securement foundation are configured in a closed state via the hinge, the securement cover and the securement foundation form a housing with a guide channel within the elongated portion for securing the catheter, the guide channel having approximately a same diameter as a diameter of the medical catheter, the guide channel having an adhesive disposed thereon for restricting movement of the medical catheter,

wherein the film comprises a catheter entry point for insertion of the catheter into the body, and wherein the circular portion of the securement foundation is aligned with the catheter entry point such that the catheter protruding from the body enters through the catheter entry point of the film and enters the guide channel,

wherein the securement cover further comprises positional shift alert media configured to indicate positional shifts by the catheter relative to the housing,

wherein the position shift alert media comprises a positional indicator embedded in the adhesive disposed on the surface of the guide channel, wherein when the securement cover and the securement foundation are configured in the closed state, the positional indicator is fixedly attached to the catheter via the adhesive, and

wherein the securement cover is constructed of a clear medical grade silicone material, and wherein the positional shift alert media further comprises a plurality of tinted regions in the securement cover, wherein the positional indicator fixedly attached to the catheter is viewable from a top view through a top surface of the securement cover.