Splitable tip catheter with bioresorbable adhesive

• US 9,782,535 B2
• Filed: 03/31/2015
• Issued: 10/10/2017
• 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): MARCETICH, ADAM M
• Application Number:
  US14/675,236
• Publication Number:
  US 20150335810A1
• Time in Patent Office: 924 Days
• 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 making of catheters A61M25/0009
• 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 method for hemodialysis, comprising:

providing a multi-lumen catheter assembly 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 for blood extraction and return, the distal tip portions joined together by a bioresorbable adhesive including a bonding element and a degradable element, at least a portion of the bioresorbable adhesive disposed between the distal tip portions;

inserting the distal end of the multi-lumen catheter assembly into a blood vessel; and

allowing the bioresorbable adhesive to degrade such that the distal tip portions separate from each other within the blood vessel.

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

3. The method according to claim 1, wherein the adhesive comprises a hydrophilic polymer.

4. The method according to claim 1, wherein the adhesive degrades in the blood vessel to provide separation of the distal tip portions from each other in less than an hour.

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

6. The method according to claim 1, wherein the adhesive comprises a protein, a sugar, and a starch.

7. The method according to claim 1, wherein the adhesive comprises an antithrombotic, anti-septic, or anti-stenotic agent.

8. The method according to claim 1, wherein the distal tip portions are flexible.

9. The method according to claim 1, wherein the distal tip portions are of different lengths.

10. The method according to claim 1, wherein the blood extraction and return lumens have different cross-sectional areas.

11. The method according to claim 1, wherein at least one of the distal tip portions has a plurality of openings for fluid flow.

12. The method according to claim 1, wherein the multi-lumen catheter assembly has a unibody construction with the blood extraction lumen and the blood return lumen incorporated therein.

13. The method according to claim 1, wherein the blood extraction and return lumens are separate tubular elements and partially joined by an outer sheath.

14. The method according to claim 1, wherein the adhesive covers at least a portion of an outer surface of each distal tip portion.

15. The method according to claim 1, wherein the adhesive applied to a surface of each distal tip portion forms a continuous linear bond.

16. The method according to claim 1, wherein the adhesive applied to a surface of each distal tip portion forms discrete spots.

17. The method according to claim 1, wherein at least one distal tip portion comprises a shape memory material.

18. The method according to claim 1, wherein the distal tip portions are in a coiled configuration.

19. The method according to claim 1, wherein the multi-lumen catheter assembly contains an additional lumen for fluid administration or sampling.

20. A method for hemodialysis, comprising:

providing a multi-lumen catheter assembly 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 for blood extraction and return, a memory gap formed between the blood extraction lumen and the blood return lumen, the distal tip portions joined together by a bioresorbable adhesive including a bonding element and a degradable element; and

inserting the distal end of the multi-lumen catheter assembly into a blood vessel; and

allowing the adhesive to degrade such that the distal tip portions separate from each other within the blood vessel;

wherein the memory gap facilitates the separation of the distal tip portions from each other to a pre-adhesive position following degradation of the adhesive.