Compliant catheter adapter having self-slitting needle

• US 10,463,840 B2
• Filed: 10/05/2016
• Issued: 11/05/2019
• Est. Priority Date: 10/28/2015
• Status: Active Grant

• Current Assignee: Becton, Dickinson & Co
• Original Assignee: Becton, Dickinson & Co
• Inventors: Hyer, Daniel Kirk, Maul, Christopher, Davis, Eric, Wang, Bin, Ellis, Carl, Christensen, Corey, Burkholz, Jonathan Karl, Peterson, Bart D.
• Primary Examiner(s): Gray, Phillip A
• Application Number:
  US15/286,223
• Publication Number:
  US 20170120001A1
• Time in Patent Office: 1,126 Days
• Field of Search: 604167
• CPC Class Codes: A61M 2039/062 used with a catheter
• CPC Class Codes: A61M 25/0097 characterised by the hub connectors A61M39/10
• CPC Class Codes: A61M 25/0606 "Over-the-needle" catheter assemblies, e.g. I.V. catheters
• CPC Class Codes: A61M 25/0637 Butterfly or winged devices, e.g. for facilitating handling or for attachment to the skin
• CPC Class Codes: A61M 25/0693 Flashback chambers
• CPC Class Codes: A61M 39/06 Haemostasis valves, i.e. gaskets sealing around a needle, catheter or the like, closing on removal thereof
• CPC Class Codes: A61M 5/3286 Needle tip design, e.g. for improved penetration
• CPC Class Codes: A61M 5/3291 Shafts with additional lateral openings

Abstract

A self-slitting open lumen cannula may be used with catheter adapters to reduce manufacturing complexity and costs, as well as improve the safety of the catheter adapters against fluid leakage. The open lumen cannula may also include one or more notches to facilitate flashback visualization. The catheter adapters may further include a catheter adapter body formed of a compliant material that houses one or more compression resistant septa with at least one lumen formed by the proximal end of the needle during a self-slitting process as the catheter adapter is assembled. The compression resistant septum may also be coupled to a compression cap that imparts a radial compression force on the one or more compression resistant septa such that the at least one lumen narrows and seals when the cannula is removed.

Claims

1. A compliant catheter adapter comprising:

a needle comprising;

a proximal end, the proximal end of the needle shaped to facilitate a self-slitting/self-guiding process during assembly of the catheter adapter;

a distal end; and

a plurality of openings disposed along the needle between the proximal end and the distal end of the needle, wherein the plurality of openings are configured to facilitate flashback visualization;

a catheter adapter body formed of a compliant material, the catheter adapter body comprising;

a proximal end and a distal end, the catheter adapter body having a generally elongate shape formed about a longitudinal axis extending between the proximal end and the distal end of the catheter adapter body;

an inner chamber disposed within the catheter adapter body, the inner chamber having a generally elongate shape formed about the longitudinal axis extending between the proximal end and the distal end of the catheter adapter body;

a compression resistant septum comprising a distal end formed in the compliant material of the catheter adapter body, the compression resistant septum further comprising a proximal end, wherein the distal end of the compression resistant septum and the catheter adapter body are integrally formed of the same compliant material, the compression resistant septum disposed toward the proximal end of the catheter adapter body; and

a lumen formed through the compression resistant septum by the proximal end of the needle during the self-slitting process as the catheter adapter is assembled; and

a compression cap coupled to the proximal end of the compression resistant septum, the compression cap configured to impart a radial compression force to the compression resistant septum such that the lumen narrows and seals when the needle is removed from the lumen.

2. The compliant catheter adapter of claim 1, wherein the catheter adapter body is integrally formed from a compression set resistant elastomeric material.

3. The compliant catheter adapter of claim 2, wherein the compression set resistant elastomeric material comprises one of a thermoplastic elastomer material, a liquid silicone rubber material, and a polyisoprene material.

4. The compliant catheter adapter of claim 1, wherein the compression cap further comprises:

a proximal end having a first aperture configured to receive the needle there through;

a distal end having a second aperture configured to receive at least a portion of the catheter adapter body; and

a compression surface extending intermediate the proximal end and the distal end of the compression cap, the compression surface enclosing a hollow portion formed in the compression cap, the hollow portion configured to receive at least a portion of the compression resistant septum therein, and the compression surface configured to impart the radial compression force to the compression resistant septum such that the lumen narrows and seals when the needle is removed from the lumen.

5. The compliant catheter adapter of claim 4, wherein the compression cap is a separate piece that is coupled to the compression resistant septum.

6. The compliant catheter adapter of claim 4, wherein the compression cap is integrally formed with the compression resistant septum.

7. The compliant catheter adapter of claim 6, wherein the compression cap is coupled to the compression resistant septum through an over-molding manufacturing process.

8. The compliant catheter adapter of claim 1, further comprising:

one or more stabilization members coupled to the catheter adapter body and configured to stabilize the catheter adapter body with respect to a patient;

a port in fluid communication with the inner chamber and configured to receive an extension tube, the port comprising one of a Y-shaped port, a T-shaped port, a V-shaped port and a parallel-shaped port;

a catheter lumen coupled to and extending from the distal end of the catheter adapter body; and

a catheter wedge disposed toward the distal end of the catheter adapter body and configured to guide the needle into the catheter lumen as the needle is inserted through the catheter adapter body.

20. The compliant catheter adapter of claim 1, wherein a majority or substantially all of the compression resistant septum is disposed within the compression cap.

9. A compliant catheter adapter comprising:

a needle comprising;

a proximal end, the proximal end of the needle shaped to facilitate a self-slitting/self-guiding process during assembly of the catheter adapter;

a distal end; and

a plurality of openings disposed along the needle between the proximal end and the distal end of the needle, wherein the plurality of openings are configured to facilitate flashback visualization;

a catheter adapter body formed of a compliant material, the catheter adapter body comprising;

a proximal end and a distal end, the catheter adapter body having a generally elongate shape formed about a longitudinal axis extending between the proximal end and the distal end of the catheter adapter body; and

an inner chamber disposed within the catheter adapter body, the inner chamber having a generally elongate shape formed about the longitudinal axis extending between the proximal end and the distal end of the catheter adapter body;

a compression resistant septum comprising a distal end formed in the compliant material of the catheter adapter body, the compression resistant septum further comprising a proximal end, wherein the distal end of the compression resistant septum and the catheter adapter body are integrally formed of the same compliant material, the compression resistant septum disposed toward the proximal end of the catheter adapter body the compression resistant septum comprising a lumen formed by the proximal end of the needle during the self-slitting process as the catheter adapter is assembled; and

a compression cap coupled to the proximal end of the compression resistant septum to the catheter adapter body and impart a radial compression force to the compression resistant septum such that the lumen narrows and seals when the needle is removed from the lumen.

10. The compliant catheter adapter of claim 9, wherein the compliant material comprises a thermoplastic elastomer material, a liquid silicone rubber material, or a polyisoprene material.

11. The compliant catheter adapter of claim 9, wherein the compression cap is positioned within at least a portion of the proximal end of the catheter adapter body, the compression cap further comprising:

a proximal end having a first aperture configured to receive the needle there through;

a distal end having a second aperture configured to receive at least a portion of the catheter adapter body; and

a compression surface extending intermediate the proximal end and the distal end of the compression cap, the compression surface enclosing a hollow portion formed in the compression cap, the hollow portion configured to receive the compression resistant septum therein, and the compression surface configured to impart the radial compression force to the compression resistant septum such that the lumen narrows and seals when the needle is removed from the lumen.

12. The compliant catheter adapter of claim 9, further comprising:

one or more stabilization members coupled to the catheter adapter body and configured to stabilize the catheter adapter body with respect to a patient;

a port in fluid communication with the inner chamber and configured to receive an extension tube, and the port comprising one of a Y-shaped port, a T-shaped port, a V-shaped port, and a parallel-shaped port;

a catheter lumen coupled to and extending from the distal end of the catheter adapter body; and

a catheter wedge disposed toward the distal end of the catheter adapter body and configured to guide the needle into the catheter lumen as the needle is inserted through the catheter adapter body.

13. The compliant catheter adapter of claim 9, wherein the compression resistant septum is a first compression resistant septum, further comprising a second compression resistant septum disposed within the inner chamber of the catheter adapter body, the second compression resistant septum positioned to abut the first compression resistant septum, wherein a septum chamber is formed between the first compression resistant septum and the second compression resistant septum, the second compression resistant septum having a second lumen formed by the proximal end of the needle during the self-slitting process as the catheter adapter is assembled.

14. The compliant catheter adapter of claim 9, wherein the compression cap is a separate piece that is coupled to the compression resistant septum and the catheter adapter body.

15. The compliant catheter adapter of claim 9, wherein the compression cap is coupled to the compression resistant septum and the catheter adapter body through an over-molding manufacturing process.

16. A catheter system comprising:

a needle component including;

a needle hub;

a needle coupled to the needle hub and extending distally from the needle hub, the needle comprising;

a proximal end, the proximal end of the needle shaped to facilitate a self-slitting/self-guiding process during assembly of the catheter adapter;

a distal end; and

a plurality of openings disposed along the needle between the proximal end and the distal end of the needle, wherein the plurality of openings are configured to facilitate flashback visualization; and

a grip coupled to the needle hub;

a catheter adapter body formed of a compliant material, the catheter adapter body comprising;

a proximal end and a distal end, the catheter adapter body having a generally elongate shape formed about a longitudinal axis extending between the proximal end and the distal end of the catheter adapter body;

an inner chamber disposed within the catheter adapter body, the inner chamber having a generally elongate shape formed about the longitudinal axis extending between the proximal end and the distal end of the catheter adapter body; and

a compression resistant septum comprising a distal end formed in the compliant material of the catheter adapter body, the compression resistant septum further comprising a proximal end, wherein the distal end of the compression resistant septum and the catheter adapter body are integrally formed of the same compliant material, the compression resistant septum disposed toward the proximal end of the catheter adapter body and comprising a lumen formed by the proximal end of the needle during the self-slitting process as the catheter adapter is assembled; and

a compression cap coupled to the proximal end of the compression resistant septum, the compression cap configured to impart a radial compression force to the compression resistant septum such that the lumen narrows and seals when the needle is removed from the lumen.

17. The catheter system of claim 16, wherein the grip coupled to the needle hub further comprises one of a paddle grip, a straight grip, and a ported grip.

18. The catheter system of claim 16, wherein the catheter adapter body is integrally formed from a compression set resistant elastomeric material comprising one of a thermoplastic elastomer material, a liquid silicone rubber material, and a polyisoprene material.

19. The catheter system of claim 16, wherein the compression cap further comprises:

a proximal end having a first aperture configured to receive the needle there through;

a distal end having a second aperture configured to receive at least a portion of the catheter adapter body; and

a compression surface extending intermediate the proximal end and the distal end of the compression cap, the compression surface enclosing a hollow portion formed in the compression cap, the hollow portion configured to receive at least a portion of the compression resistant septum therein, and the compression surface configured to impart the radial compression force to the compression resistant septum such that the lumen narrows and seals when the needle is removed from the lumen.