Splitable tip catheter with bioresorbable adhesive

• US 8,992,454 B2
• Filed: 06/09/2004
• Issued: 03/31/2015
• 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:
  US10/874,298
• Publication Number:
  US 20050277862A1
• Time in Patent Office: 3,947 Days
• Field of Search: 604/5.01, 604/4.01, 604/6.16
• US Class Current: 604/5.01
• 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 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 extraction lumen with the blood vessel,

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

a cyanoacrylate-free bioresorbable adhesive, comprising a bonding element and a degradable element, located between the separable distal tip portions to join the distal tip portions together prior to insertion into a blood vessel, the bioresorbable adhesive enabling the distal tip portions to separate following insertion;

wherein at least one distal tip portion is made of a shape memory material to facilitate an angular separation of the distal tip portions from each other to a pre-adhesive position following degradation of the adhesive.

2. The device of claim 1, wherein the extraction and 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 adhesive comprises a hydrophilic polymer.

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

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

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

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

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

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

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

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

12. The device of claim 1, wherein the distal tip portions each have at least one opening for fluid flow, the fluid flow facilitating the dissolution of the adhesive and separation of the distal tip portions from each other following insertion.

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

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

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

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

17. The device of claim 1, wherein the adhesive is applied to a surface of each distal tip portion in a continuous linear bond.

18. The device of claim 1, wherein the adhesive is applied to a surface of each distal tip portion at discrete regions.

19. The device of claim 1, wherein at least one distal tip portion is coiled about another tip portion.

20. The device of claim 1, wherein the catheter contains an additional lumen for fluid administration, the fluid administration facilitating the dissolution of the adhesive and separation of the distal tip portions from each other following insertion.

21. The device of claim 20, wherein the additional lumen extends longitudinally between the blood extraction lumen and the blood return lumen, the additional lumen configured to direct fluid of the fluid administration at the adhesive between the separable distal tip portions to facilitate dissolution of the adhesive.

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

a proximal end adapted for coupling to a hemodialysis apparatus;

a distal end terminating in a first distal tip portion and a second distal tip portion separably attached together with a cyanoacrylate-free bioresorbable adhesive comprising a bonding element and a degradable element, wherein dissolution of the bioresorbable adhesive following insertion of the distal end in a blood vessel enables the first distal tip portion and the second distal tip portion to separate;

a first lumen for blood extraction extending longitudinally from the proximal end through the first distal tip portion;

a second lumen for blood return extending longitudinally from the proximal end through the second distal tip portion; and

a third lumen extending longitudinally in between the first lumen and the second lumen from the proximal end to a separation point between the first distal tip portion and the second distal tip portion, wherein the third lumen is designed such that fluid administered through the third lumen is directed from the third lumen at the bioresorbable adhesive between the first distal tip portion and the second distal tip portion to facilitate the dissolution of the bioresorbable adhesive and separation of the first distal tip portion and the second distal tip portion.

23. The device of claim 22, wherein at least one of the first distal tip portion and the second distal tip portion is made of a shape memory material to facilitate an angular separation of the first distal tip portion and the second distal tip portion from each other to a pre-adhesive position following dissolution of the adhesive.

24. The device of claim 22, wherein at the separation point the third lumen splits into a first lumen half located in a first surface of the first distal tip portion and a second lumen half located in a second surface of the second distal tip portion, wherein the first surface and the second surface face each other.