VASCULAR ACCESS CONFIGURATION

• US 20170281908A1
• Filed: 06/19/2017
• Published: 10/05/2017
• Est. Priority Date: 05/25/2012
• Status: Active Grant

• Current Assignee: Arstasis, Inc.
• Original Assignee: Arstasis, Inc.
• Inventors: Ellingwood, Brian Andrew, Modesitt, D. Bruce
• Granted Patent: US 10,441,753 B2
• Time in Patent Office: Days
• CPC Class Codes: A61B 17/3415 for introducing tubes or catheters, e.g. gastrostomy tubes, drain catheters A61B17/3417 takes precedence; body piercing catheter guide needles A61M25/06
• 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 2039/0258 for vascular access, e.g. blood stream access
• CPC Class Codes: A61M 2039/0273 for introducing catheters into the body
• CPC Class Codes: A61M 25/0069 Tip not integral with tube
• CPC Class Codes: A61M 25/02 Holding devices, e.g. on the body
• CPC Class Codes: A61M 25/0662 Guide tubes
• CPC Class Codes: A61M 25/09 Guide wires
• CPC Class Codes: A61M 29/00 Dilators with or without means for introducing media, e.g. remedies instruments for performing visual medical inspections of cavities or tubes of the body A61B1/00
• CPC Class Codes: A61M 39/0247 Semi-permanent or permanent transcutaneous or percutaneous access sites to the inside of the body peritoneal dialysis catheters A61M1/285; tracheostomy devices A61M16/0465; measuring pressure within the body A61B5/03; colostomy devices A61F5/445; gastrotomy feeding tubes A61J15/0015; means for fixing a feeding tube outside of the body A61J15/0053

Abstract

One embodiment is directed to a system for creating translumenal vascular access, comprising a dilator adaptor member having proximal and distal ends and defining a dilator adaptor lumen therethrough, wherein the dilator adaptor lumen is defined by an inner diameter profile sized to accommodate insertion of one or more portions of a guidewire, and wherein the dilator adaptor is further defined by an outer diameter profile sized to accommodate at least partial insertion of the proximal end of the dilator adaptor into a dilator member lumen formed through a dilator member, the dilator member being coupleable to an introducer catheter member through an introducer member lumen formed through the introducer member.

Claims

1. A system for creating translumenal vascular access, comprising:

a. a dilator-introducer assembly comprising a dilator member having proximal and distal ends and defining a dilator lumen therethrough, and an introducer member having proximal and distal ends and defining an introducer lumen therethrough, wherein the introducer lumen is defined by an inner diameter profile sized to accommodate insertion of one or more portions of the dilator member;

b. a guidewire having an outer shape defined by a guidewire outer diameter profile;

c. a dilator adaptor having proximal and distal ends and defining a dilator adaptor lumen therethrough, wherein the dilator adaptor lumen is defined by an inner diameter profile sized to accommodate insertion of one or more portions of the guidewire, and wherein the dilator adaptor is further defined by an outer diameter profile sized to accommodate at least partial insertion of the proximal end of the dilator adaptor into the dilator member lumen;

wherein the guidewire may be advanced at least in part through the dilator adaptor lumen, the dilator adaptor may be advanced at least in part through the dilator member lumen, and the dilator member may be advanced at least in part through the introducer lumen to form an instrument assembly capable of forming substantially atraumatic outer shape profile configuration defined by longitudinally sequential increases in overall outer diameter from exposed distal ends of the guidewire, dilator adaptor, dilator member, and introducer.

2. The system of claim 1, wherein a maximum outer diameter of the guidewire is substantially smaller than a minimum inner diameter of the dilator member.

3. The system of claim 2, wherein without the dilator adaptor interposed between the guidewire and dilator member, an annular gap would be defined at the intersection of the guidewire and the distal end of the dilator member.

4. The system of claim 2, wherein the maximum outer diameter of the guidewire is at least about 25% smaller than the minimum inner diameter of the dilator member.

5. The system of claim 2, wherein the maximum outer diameter of the guidewire is about 0.018 inches.

6. The system of claim 5, wherein the minimum inner diameter of the dilator member is between about 0.035 inches and about 0.040 inches.

7. The system of claim 3, wherein the dilator adaptor inner and outer diameter profiles are configured to substantially make up the difference in fit between the guidewire and dilator member.

8. The system of claim 6, wherein the dilator adaptor has a minimum inner diameter of about 0.018 inches, and a maximum outer diameter of about 0.050 inches.

9. The system of claim 1, wherein the introducer member distal end has a tapered geometry with an outer diameter minimum at its distal tip.

10. The system of claim 1, wherein the dilator member distal end has a tapered geometry with an outer diameter minimum at its distal tip.

11. The system of claim 1, wherein the distal end of the dilator adaptor has a tapered geometry with an outer diameter minimum at its distal tip.

12. The system of claim 1, wherein at least a portion of the dilator adaptor has a proximally tapered geometry with an outer diameter minimum located adjacent its proximal end.

13. The system of claim 12, wherein a friction fit may be formed between the proximally tapered geometry of the dilator adaptor and the dilator lumen of the dilator member when loading the dilator adaptor into the dilator lumen.

14. The system of claim 13, wherein the proximally tapered geometry is selected such that one size of dilator adaptor can form a friction fit with a range of dilator lumen geometries.

15. The system of claim 1, wherein the dilator adaptor, when viewed from distal end to proximal end, comprises a distal section with a substantially constant outer diameter for a distal section length, tapering up to a midsection with a substantially constant outer diameter for a midsection length, tapering down to a proximal section with a substantially constant outer diameter for a proximal section length, ending in the proximal end.

16. The system of claim 15, wherein the substantially constant outer diameter of the proximal section is greater than that of the distal section and less than that of the midsection.

17. The system of claim 16, wherein each of the distal section, midsection, and proximal sections has a substantially homogeneous inner diameter defining the dilator adaptor lumen.

18. The system of claim 2, wherein the maximum outer diameter of the guidewire is at least about 0.01 inches smaller than the minimum inner diameter of the dilator member.

19. The system of claim 1, wherein the dilator adaptor comprises a polymer selected from the group consisting of:

polyethylene terepthalate, polyethylene, high density polyethylene, polypropylene, polytetrafluoroethylene, expanded polytetrafluoroethylene, poly (ethylene-co-vinyl acetate), poly(butyl methacrylate), and co-polymers thereof.