Bleed back control assembly and method

• US 6,575,960 B2
• Filed: 12/18/2000
• Issued: 06/10/2003
• Est. Priority Date: 03/11/1999
• Status: Expired due to Term

• Current Assignee: Guidant Corporation (Boston Scientific Corporation)
• Original Assignee: Advanced Cardiovascular Systems Incorporated (Abbott Laboratories)
• Inventors: Thompson, Gary, Haldeman, Paul, Becker, Neil M., Clarke, Duncan, Wilson, Victor, Tarver, LaShun D., Colvan, William P., Peterson, Charles R., Wilson, Bruce, Armstrong, Kenneth K., Quinones, Albert A.
• Primary Examiner(s): Casler, Brian L.
• Assistant Examiner(s): Sirmons, Kevin C.
• Application Number:
  US09/739,720
• Publication Number:
  US 20010021825A1
• Time in Patent Office: 904 Days
• Field of Search: 604/537, 604/284, 604/167-1-1, 604/246, 604/249, 604/256, 604/164, 604/169, 604/533, 604/534, 604/535, 604/538, 604/539
• US Class Current: 604/533
• CPC Class Codes: A61M 2039/0633 the seal being a passive seal made of a resilient material with or without an opening
• CPC Class Codes: A61M 2039/064 Slit-valve
• CPC Class Codes: A61M 2039/0686 comprising more than one seal
• CPC Class Codes: A61M 39/06 Haemostasis valves, i.e. gaskets sealing around a needle, catheter or the like, closing on removal thereof
• CPC Class Codes: A61M 39/0693 including means for seal penetration

Abstract

A bleed back control assembly and method-for controlling blood loss during catheterization procedures includes a side arm body connected at the proximal end to a seal body. The side arm body comprises one or more branches, each having a lumen, and a finger rest on the exterior of at least one branch. The seal body comprises a cap assembly and a seal assembly. The seal assembly comprises a clamp seal and a bleed back seal, both made of elastomer and held by a seal holder. The cap assembly comprises a threaded cap and a funnel cap. The threaded cap is connected to the seal holder. Rotation of the threaded cap causes the clamp seal to open or close. The funnel cap comprises a dilator, and pressing the funnel cap causes the dilator to open an aperture in the bleed back control seal.

Claims

1. A bleed back control assembly comprising:

a side arm body having a proximal end, a distal end, and a lumen connecting said proximal and distal ends, said side arm body also having a seal cavity formed in said proximal end, said lumen being in fluid communication with said seal cavity;

a seal mechanism coupled to the proximal end of said side arm body, said seal mechanism comprising;

a cap assembly coupled to a seal assembly and to said proximal end of said side arm body, said cap assembly restraining said seal assembly within said seal cavity, said cap assembly comprising a funnel cap, a dilator, a biasing member, and a lumen having a proximal aperture communicating with the exterior of said cap assembly; and

said seal assembly comprising elastomeric material inhibiting said cap assembly lumen from being in fluid communication with said side arm body lumen;

wherein said cap assembly is operable to engage said seal assembly with said dilator in response to an application of an external force by the user and said biasing member is operable to disengage said dilator from said seal assembly in the absence of the application of the external force by the user.

2. The bleed back control assembly of claim 1, wherein said seal cavity has an interior distal surface including an aperture allowing fluid communication between said side arm body lumen and said seal cavity, said seal assembly comprising:

a seal holder which is movable axially, said seal holder distal to said lumen aperture and having an interior chamber; and

a bleed back control seal held within said interior chamber of said seal holder,

said bleed back control seal having an aperture which is closed unless acted upon for controlling blood loss upon operation of said assembly.

3. The bleed back control assembly of claim 2, wherein said cap assembly comprises:

a funnel cap having a proximal surface and an interior chamber, said funnel cap being movable axially and compressing said biasing member when moved distally;

a dilator coupled to and extending distally from the interior of said proximal surface into said funnel cap'"'"'s interior chamber, for dilating said bleed back control seal'"'"'s aperture; and

said dilator having a lumen connecting said proximal surface of said funnel cap to the interior of said bleed back control assembly.

4. The bleed back control assembly of claim 2, wherein said dilator comprises a tube and said bleed back control seal further comprises ears forming a seal around the exterior surface of said dilator.

5. The bleed back control assembly of claim 2, wherein said bleed back control seal resists fluid pressure of at least 20 psi when said aperture is closed.

6. The bleed back control assembly of claim 2, wherein:

said cap assembly comprises a funnel cap having a dilator formed therein,

said dilator is axially movable to open said aperture of said bleed back control seal, and

whereby said dilator allows trapped gas or fluid to be purged from the interior of said bleed back control assembly when said dilator is moved distally to open said aperture of said bleed back control seal.

7. The bleed back control assembly of claim 2, wherein said bleed back control seal is formed of an elastomer with elongation property sufficient to allow dilation and constriction of said bleed back control seal without losing seal integrity.

8. The bleed back control assembly of claim 7,

wherein said bleed back control seal is formed of polyisoprene.

9. The bleed back control assembly of claim 7,

wherein said bleed back control seal is formed of fluorosilicone.

10. The bleed back control assembly of claim 7,

wherein said bleed back control seal is formed of silicone.

11. The bleed back control assembly of claim 7,

wherein said bleed back control seal has elongation of at least approximately 750%.

12. The bleed back control assembly of claim 2,

wherein said dilator is distal to and in communication with a funnel proximal to said cap assembly, and is operable to perforate said bleed back control seal'"'"'s aperture.

13. The bleed back control assembly of claim 2,

wherein said dilator comprises a rigid hollow tube.

14. The bleed back control assembly of claim 13,

wherein said tube is formed integral with said cap assembly.

15. The bleed back control assembly of claim 2,

wherein said aperture of said bleed back control seal when closed can withstand pressure from injections introduced into said side arm body, wherein said injection pressure is in excess of hemostatic pressure.

16. The bleed back control assembly of claim 2,

wherein said bleed back control seal comprises a web area and said aperture is formed in said web area.

17. The bleed back control assembly of claim 2,

wherein said web area thins towards the center of said web area.

18. The bleed back control assembly of claim 16,

wherein said web area has a distal surface and said web area further comprises a spherical portion formed on said distal surface and said aperture is formed through said spherical portion of said web area.

19. The bleed back control assembly of claim 18,

wherein said spherical portion comprises a pressure dome and said bleed back control seal when closed is operable to resist fluid pressure up to approximately 400 psi.

20. The bleed back control assembly of claim 2,

wherein said aperture comprises a pinhole.

21. The bleed back control assembly of claim 2,

wherein said aperture comprises one or more slits.

22. The bleed back control assembly of claim 21,

wherein said slits comprise tricuspid slits and further comprise flaps.

23. The bleed back control assembly of claim 2,

wherein said seal holder provides axial support, radial support, and compression for said bleed back control seal.

24. The bleed back control assembly of claim 2, wherein said bleed back control seal comprises:

a top cylindrical section having a lumen surrounded by side walls;

a bottom cylindrical section with a lumen having a larger diameter than said top cylindrical section'"'"'s lumen;

a web area dividing said top and bottom cylindrical sections'"'"' lumens, said web area having a dilatable aperture; and

wherein said bleed back control seal is formed of an elastomer.

25. The bleed back control assembly of claim 1, wherein said side arm body further comprises:

a finger rest on the exterior surface of said side arm body.

26. The bleed back control assembly of claim 1, wherein said side arm body'"'"'s lumen is a primary lumen and said side arm body further comprises:

at least one secondary branch, each secondary branch having a lumen allowing fluid communication with said primary lumen, and

a finger rest formed on the exterior surface of at least one of said secondary branches.

27. The bleed back control assembly of claim 24, wherein said cap assembly comprises:

a funnel cap having a proximal surface and said funnel cap has a funnel formed in said proximal surface, and

said funnel being in fluid communication with the lumen of the top cylindrical section of said bleed back control assembly and facilitating introduction of devices into said bleed back control assembly.

28. The bleed back control assembly of claim 1, further comprising a luer attached to said distal end of said side arm body.

29. The bleed back control assembly of claim 1, wherein said funnel cap has a dilator formed therein, said dilator having a return spring wound thereon and engaging said seal assembly when moved distally by active user manipulation.

30. The bleed back control assembly of claim 1,

wherein said cap assembly is operable to be manipulated to move axially with one hand.

31. The bleed back control assembly of claim 1,

wherein said cap assembly is operable to be manipulated by pushing said cap assembly.

32. The bleed back control assembly of claim 1,

wherein said cap assembly is operable to be manipulated by twisting said cap assembly.

33. The bleed back control assembly of claim 1,

wherein said cap assembly is operable to control axial translation and displacement of said seal mechanism.

34. The bleed back control assembly of claim 33,

wherein displacement of said cap assembly is limited by one or more stop means.

35. The bleed back control assembly of claim 34,

wherein said stop means comprises one or more overhanging lips formed on the distal edge of said cap assembly.

36. The bleed back control assembly of claim 1, wherein said biasing member comprises a spring.

37. The bleed back control assembly of claim 1,

wherein said bleed back control assembly comprises a funnel proximal to and in communication with said cap assembly lumen.

38. The bleed back control assembly of claim 37,

wherein said cap assembly exterior comprises a proximal surface and said funnel is formed as part of said proximal surface.

39. The bleed back control assembly of claim 1,

wherein said dilator comprises a tube adapted to allow for rapid insertion of interventional devices without crimping or damaging said devices while largely preventing blood loss during their placement.

40. The bleed back control assembly of claim 39,

wherein said side arm body comprises a Y-shaped connector and said cap assembly is connected to said Y shaped connector.

41. The bleed back control assembly of claim 1,

whereby said bleed back control assembly reduces the amount of blood which escapes from a patient during vascular diagnostic or interventional procedures, and reduces risks associated with unwanted exposure to blood or other fluids, and helps physicians and clinicians more safely deal with blood borne pathogen issues.

42. The bleed back control assembly of claim 1,

whereby said bleed back control assembly is adapted for use during an intravascular therapeutic procedure that utilizes a catheter.

43. A bleed back control assembly comprising:

a side arm body having a proximal end, a distal end, a seal cavity formed in said proximal end, and a lumen connecting said proximal and distal ends;

means for controlling fluid loss connected to said proximal end, said means for controlling fluid loss comprising;

means for seal holding having an interior chamber,

means for bleed back sealing held in said interior chamber and having an aperture which is normally closed and operable to be engaged in response to an application of an external force by the user and disengaged in the absence of the application of the external force by the user,

means for dilating said aperture of said means for bleed back sealing, and means for biasing said dilating means such that said dilating means does not dilate said aperture in the absence of application of external force by the user.

44. A bleed back control assembly comprising:

a side arm body having a proximal end, a distal end, and a lumen connecting said proximal and distal ends, said side arm body also having a seal cavity formed in said proximal end, said lumen being in fluid communication with said seal cavity;

a seal mechanism coupled to the proximal end of said side arm body, said seal mechanism comprising;

a cap assembly coupled to a seal assembly and to said proximal end of said side arm body, said cap assembly restraining said seal assembly within said seal cavity, said cap assembly comprising a funnel cap, a dilator, a spring mounted within the cap assembly, and a lumen having a proximal aperture communicating with the exterior of said cap assembly; and

said seal assembly comprising elastomeric material inhibiting said cap assembly lumen from being in fluid communication with said side arm body lumen;

wherein said cap assembly is operable to engage said seal assembly with said dilator in response to an application of an external force by the user and said spring is operable to disengage said dilator from said seal assembly in the absence of the application of the external force by the user.