Connection system for tunneled catheters

• US 10,272,227 B2
• Filed: 11/06/2015
• Issued: 04/30/2019
• Est. Priority Date: 11/07/2014
• Status: Active Grant

• Current Assignee: C.R. Bard, Inc. (Becton, Dickinson & Co)
• Original Assignee: C.R. Bard, Inc. (Becton, Dickinson & Co)
• Inventors: Loesener, German
• Primary Examiner(s): Price, Nathan R
• Assistant Examiner(s): Doubrava, John A
• Application Number:
  US14/935,364
• Publication Number:
  US 20160129222A1
• Time in Patent Office: 1,271 Days
• Field of Search: 604537, 26417126
• CPC Class Codes: A61M 1/285 Catheters therefor
• CPC Class Codes: A61M 1/3661 for haemodialysis
• CPC Class Codes: A61M 2025/0006 which can be secured against axial movement, e.g. by using a locking cuff
• CPC Class Codes: A61M 2025/0031 characterized by lumina for withdrawing or delivering, i.e. used for extracorporeal circuit treatment
• 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 25/0009 Making of catheters or other medical or surgical tubes
• CPC Class Codes: A61M 25/0014 Connecting a tube to a hub
• CPC Class Codes: A61M 25/0097 characterised by the hub connectors A61M39/10
• CPC Class Codes: A61M 25/0194 Tunnelling catheters
• CPC Class Codes: A61M 39/105 Multi-channel connectors or couplings, e.g. for connecting multi-lumen tubes multi-channel connectors in general F16L37/56
• CPC Class Codes: A61M 39/12 for joining a flexible tube to a rigid attachment

Abstract

A catheter assembly is disclosed, comprising a proximal catheter assembly portion and a distal catheter assembly portion. The proximal catheter assembly portion includes a bifurcating hub that defines at least one fluid passageway. The distal catheter assembly portion includes a catheter tube that defines at least one lumen and includes a polymeric material. A cannula assembly is also disclosed and includes at least one cannula that is operably connected with the fluid passageway of the birfurcating hub. The cannula is further configured to operably connect with the lumen of the catheter tube so as to provide fluid communication between the proximal and distal catheter assembly portions when the two portions are connected. A polymeric coating is included with the cannula and the catheter tube, and is configured to provide a seal between the cannula and the catheter tube when the proximal and distal catheter assembly portions are connected together.

Claims

1. A catheter assembly, comprising:

a proximal catheter assembly portion including a bifurcating hub, the bifurcating hub including at least one fluid passageway;

a distal catheter assembly portion including a catheter tube defining at least one lumen, the catheter tube including a polymeric material;

a cannula assembly including at least one cannula operably connected with the at least one fluid passageway of the bifurcating hub, the at least one cannula further configured to operably connect with the at least one lumen of the catheter tube so as to provide fluid communication between the proximal catheter assembly portion and the distal catheter assembly portion when the proximal catheter assembly portion and the distal catheter assembly portion are connected; and

a polymeric coating including the polymeric material, the coating included with at least one of the at least one cannula and the catheter tube, the polymeric coating configured to provide a seal between the at least one cannula and the catheter tube when the proximal catheter assembly portion and the distal catheter assembly portion are connected by an interference or slip-type fit.

2. The catheter assembly as defined in claim 1, wherein the polymeric coating is included on a surface of the at least one cannula before the proximal catheter assembly portion and the distal catheter assembly portion are connected.

3. The catheter assembly as defined in claim 2, wherein the at least one cannula is received into the at least one lumen of the catheter tube.

4. The catheter assembly as defined in claim 3, wherein the polymeric coating is included on an outer surface of the at least one cannula such that the polymeric coating is positioned adjacent a portion of an interior surface of the at least one lumen of the catheter tube when the proximal catheter assembly portion and the distal catheter assembly portion are connected.

5. The catheter assembly as defined in claim 1, wherein an interface is established when the proximal catheter assembly portion and the distal catheter assembly portion are connected, the polymeric coating configured to provide sealing to prevent fluid leakage at the interface.

6. The catheter assembly as defined in claim 5, wherein the proximal catheter assembly portion is connected to the distal catheter assembly portion after the catheter tube of the distal catheter assembly portion is subcutaneously tunneled in a patient.

7. The catheter assembly as defined in claim 6, further comprising a compression component configured to compress a region surrounding the interface.

8. The catheter assembly as defined in claim 7, wherein the compression component includes a compression sleeve and wherein the compression sleeve includes a securement cuff.

9. The catheter assembly as defined in claim 5, wherein the interface is disposed within a subcutaneous tunnel of a patient after the proximal catheter assembly portion and the distal catheter assembly portion are connected.

10. The catheter assembly as defined in claim 1, wherein the at least one fluid passageway of the bifurcating hub is operably connected to at least one extension leg.

11. The catheter assembly as defined in claim 1, wherein the polymeric material includes polyurethane.

12. The catheter assembly as defined in claim 1, wherein the polymeric material includes at least one of at least one of polyurethane, silicone, polyester, polyethyleneterephthalate, polyethylene, high density polyethylene, polyvinylchloride, low-density polyethylene, polypropylene, polystyrene, polyamides, nylons, acrylonitrilebutadiene styrene, polycarbonate, polycarbonate/acrylonitrile butadienestyrene, polyetheretherketone, and polytetrafluoroethylene.

13. The catheter assembly as defined in claim 1, wherein the at least one cannula is bead blasted prior to application of the polymeric coating.

14. The catheter assembly as defined in claim 1, wherein the at least one cannula is operably connected to the at least one fluid passageway of the bifurcating hub via a proximal tube portion interposed between the cannula assembly and the bifurcating hub.

15. The catheter assembly as defined in claim 14, wherein the proximal tube portion includes a securement cuff.

16. A catheter assembly, comprising:

a proximal catheter assembly portion including a bifurcating hub, the bifurcating hub including a plurality of fluid passageways;

a distal catheter assembly portion including a catheter tube defining a plurality of lumens, the catheter tube including a polymeric material;

a cannula assembly including a plurality of cannulae, the plurality of cannulae operably connected to corresponding fluid passageways of the bifurcating hub and the plurality of lumens of the catheter tube;

each of the plurality of cannulae further configured to operably connect with a corresponding one of the plurality of lumens of the catheter tube so as to provide fluid communication between the proximal catheter assembly portion and the distal catheter assembly portion when the proximal catheter assembly portion and the distal catheter assembly portion are connected; and

a polymeric coating including the polymeric material, the coating included on a surface of the plurality of cannulae, the polymeric coating configured to provide a polymer-knitted seal with the polymeric material of the catheter tube when the proximal catheter assembly portion and the distal catheter assembly portion are connected.

17. The catheter assembly as defined in claim 16, wherein at least one of the plurality of cannulae is received into at least one lumen of the plurality of lumens of the catheter tube.

18. The catheter assembly as defined in claim 17, wherein the polymeric coating is included on an outer surface of the at least one cannula such that the polymeric coating is positioned adjacent a portion of an interior surface of the at least one lumen of the catheter tube when the proximal catheter assembly portion and the distal catheter assembly portion are connected.

19. The catheter assembly as defined in claim 16, wherein an interface is established when the proximal catheter assembly portion and the distal catheter assembly portion are connected, the polymeric coating configured to provide sealing to prevent fluid leakage at the interface.

20. The catheter assembly as defined in claim 19, wherein the proximal catheter assembly portion is connected to the distal catheter assembly portion after the catheter tube of the distal catheter assembly portion is subcutaneously tunneled in a patient.

21. The catheter assembly as defined in claim 20, further comprising a compression component configured to compress a region surrounding the interface.

22. The catheter assembly as defined in claim 16, wherein the polymeric material includes polyurethane.

23. The catheter assembly as defined in claim 16, wherein the polymeric material includes at least one of at least one of polyurethane, silicone, polyester, polyethyleneterephthalate, polyethylene, high density polyethylene, polyvinylchloride, low-density polyethylene, polypropylene, polystyrene, polyamides, nylons, acrylonitrilebutadiene styrene, polycarbonate, polycarbonate/acrylonitrile butadiene styrene, polyetheretherketone, and polytetrafluoroethylene.

24. A reverse-tunneled catheter assembly, comprising:

a proximal catheter assembly portion including a bifurcating hub with a fluid passageway;

a distal catheter assembly portion including a catheter tube of a polymeric material;

a cannula assembly including a cannula configured to fluidly connect a lumen of the catheter tube to the fluid passageway of the bifurcating hub for fluid communication between the proximal catheter assembly portion and the distal catheter assembly portion; and

a polymeric coating of the polymeric material on an outer surface of the cannula, the polymeric coating configured to provide a polymer-knitted seal between the cannula and the catheter tube when the cannula and the catheter tube are connected by an interference or slip-type fit.

25. The reverse-tunneled catheter assembly of claim 24, wherein the cannula and the catheter tube are configured to be connected after the catheter tube is tunneled in a patient in a reverse tunneling procedure.

26. The reverse-tunneled catheter assembly of claim 25, wherein the polymeric coating on the outer surface of the cannula is positioned adjacent an inner surface of the lumen of the catheter tube when the cannula and the catheter tube are connected.

27. The reverse-tunneled catheter assembly of claim 24, wherein the outer surface of the cannula includes a bead-blasted, medium coarse finish under the polymeric coating.

28. The reverse-tunneled catheter assembly of claim 24, wherein the polymeric material is selected from polyurethane, silicone, polyester, polyethyleneterephthalate, polyethylene, high density polyethylene, polyvinylchloride, low-density polyethylene, polypropylene, polystyrene, polyamides, nylons, acrylonitrilebutadiene styrene, polycarbonate, polycarbonate/acrylonitrile butadienestyrene, polyetheretherketone, and polytetrafluoroethylene.

29. The reverse-tunneled catheter assembly of claim 24, wherein the polymeric material is polyurethane.

30. The reverse-tunneled catheter assembly of claim 24, wherein the outer surface of the cannula includes a bead-blasted, medium coarse finish under the polymeric coating, the polymeric material being polyurethane such that the polymeric coating of polyurethane on the outer surface of the cannula is positioned adjacent an inner surface of the lumen of the catheter tube of polyurethane when the cannula and the catheter tube are connected after tunneling the catheter tube in a patient in a reverse tunneling procedure.