Splitable tip catheter with bioresorbable adhesive

• US 9,669,149 B2
• Filed: 03/14/2008
• Issued: 06/06/2017
• Est. Priority Date: 06/09/2004
• Status: Active Grant

• Current Assignee: BARD Access Systems Incorporated (Becton, Dickinson & Co)
• Original Assignee: BARD Access Systems Incorporated (Becton, Dickinson & Co)
• Inventors: Anand, Paramjith
• Primary Examiner(s): SU, SUSAN SHAN
• Application Number:
  US12/048,871
• Publication Number:
  US 20080214980A1
• Time in Patent Office: 3,371 Days
• Field of Search: 604 401, 604 616, 604 501
• CPC Class Codes: A61M 1/285 Catheters therefor
• CPC Class Codes: A61M 1/3661 for haemodialysis
• CPC Class Codes: A61M 2025/0031 characterized by lumina for withdrawing or delivering, i.e. used for extracorporeal circuit treatment
• CPC Class Codes: A61M 2025/0034 characterized by elements which are assembled, connected or fused, e.g. splittable tubes, outer sheaths creating lumina or separate cores
• CPC Class Codes: A61M 2025/0188 having slitted or breakaway lumens
• CPC Class Codes: A61M 25/0026 Multi-lumen catheters with stationary elements catheter assemblies comprising a catheter in combination with a guide tube, sheath or sleeve A61M2025/0681; catheters comprising telescoping coaxial elements A61M2025/0175
• CPC Class Codes: A61M 25/003 characterized by features relating to least one lumen located at the distal part of the catheter, e.g. filters, plugs or valves catheter tips A61M25/0067
• CPC Class Codes: A61M 25/0032 characterized by at least one unconventionally shaped lumen, e.g. polygons, ellipsoids, wedges or shapes comprising concave and convex parts
• CPC Class Codes: A61M 25/0068 Static characteristics of the catheter tip, e.g. shape, atraumatic tip, curved tip or tip structure
• CPC Class Codes: A61M 25/007 Side holes, e.g. their profiles or arrangements; Provisions to keep side holes unblocked
• CPC Class Codes: A61M 25/0071 Multiple separate lumens multiple separate lumens throughout the catheter A61M25/0026
• CPC Class Codes: A61M 25/0074 Dynamic characteristics of the catheter tip, e.g. openable, closable, expandable or deformable
• CPC Class Codes: A61M 25/008 Strength or flexibility characteristics of the catheter tip

Abstract

Splitable-tip catheters are disclosed with bioresorbable adhesive to provide spatial separation of distal tip elements during use. The invention can be particularly useful in hemodialysis applications where it is desirable to separate blood extraction and return lumens. The adhesive facilitates insertion of the distal end of the catheter as an assembly, e.g., into a blood vessel using a single guidewire, while the bioresorbable nature of the adhesive allows the tip elements to separate in vivo.

Claims

1. A multi-lumen catheter device for hemodialysis, comprising:

an elongate catheter body with at least a blood extraction lumen and a blood return lumen extending longitudinally therethrough, having a proximal end adapted for coupling to a hemodialysis apparatus, and having a distal end terminating in separable distal tip portions adapted for insertion in a blood vessel, the distal end further comprising;

a distal extraction tip portion for fluidic coupling of the blood extraction lumen with the blood vessel;

a distal return tip portion for fluidic coupling of the blood return lumen with the blood vessel;

at least one gap between the distal extraction tip portion and the distal return tip portion that facilitates the entry of fluid between the distal tip portions; and

a bioresorbable adhesive located between the separable distal tip portions distal to the at least one gap, the adhesive configured to join the distal tip portions together for insertion into the blood vessel while maintaining the at least one gap between the distal tip portions, the bioresorbable adhesive dissolvable in blood of the blood vessel, thereby facilitating separation of the distal tip portions from each other following insertion.

2. The device of claim 1, wherein the blood extraction and blood return lumens are independent of each other to provide simultaneous flow of blood in opposite directions during hemodialysis.

3. The device of claim 1, wherein the bioresorbable adhesive comprises a hydrophilic polymer.

4. The device of claim 1, wherein the bioresorbable adhesive comprises a water-soluble composition.

5. The device of claim 1, wherein the bioresorbable adhesive degrades in blood to provide separation of the distal tip portions from each other in less than an hour.

6. The device of claim 1, wherein the bioresorbable adhesive degrades in blood in a time period ranging from about 1 second to about 7 days.

7. The device of claim 1, wherein the bioresorbable adhesive degrades in blood in a time period ranging from about 1 second to about 1 day.

8. The device of claim 1, wherein the bioresorbable adhesive degrades in blood in a time period ranging from about 1 second to about 1 hour.

9. The device of claim 1, wherein the bioresorbable adhesive comprises a composition selected from a group consisting of polylactides, polyglycolides, polylactones, polyorthoesters, polyanhydrides, and copolymers thereof.

10. The device of claim 1, wherein the bioresorbable adhesive comprises a protein, a sugar, and a starch.

11. The device of claim 1, wherein the bioresorbable adhesive comprises an antithrombotic, an anti-septic, or an anti-stenotic agent.

12. The device of claim 1, wherein the distal tip portions are of different lengths.

13. The device of claim 1, wherein the blood extraction and blood return lumens have different cross-sectional areas.

14. The device of claim 1, wherein at least one of the distal tip portions has a plurality of openings for fluid flow.

15. The device of claim 1, wherein the elongate catheter body has an unibody construction with the blood extraction lumen and the blood return lumen incorporated therein.

16. The device of claim 1, wherein the blood extraction and the blood return lumens are separate tubular elements and partially joined by an outer sheath.

17. The device of claim 1, wherein the bioresorbable adhesive covers at least a portion of an outer surface of each distal tip portion.

18. The device of claim 1, wherein the bioresorbable adhesive applied to a surface of each distal tip portion forms a continuous linear bond.

19. The device of claim 1, wherein the bioresorbable adhesive applied to a surface of each distal tip portion forms discrete spots.

20. The device of claim 1, wherein at least one distal tip portion comprises a shape memory material.

21. The device of claim 20, wherein the shape memory material is configured to facilitate an angular separation of the distal tip portions from each other to a pre-adhesive position following dissolution of the bioresorbable adhesive.

22. The device of claim 1, wherein at least one of the distal tip portions is coiled about another of the distal tip portions.

23. The device of claim 1, wherein the elongate catheter body contains an additional lumen for fluid administration or sampling.

24. The device of claim 1, wherein the bioresorbable adhesive comprises a bonding element and a degradable element.

25. The device of claim 1, further comprising a third lumen extending longitudinally along a length of the device from the proximal end to a separation point between the distal tip portions, wherein the third lumen is designed such that fluid administered through the third lumen is directed from the third lumen at the bioresorbable adhesive located between the separable distal tip portions to facilitate the dissolution of the bioresorbable adhesive and separation of the distal tip portions.