Bleed back control assembly and method

• US 20010021825A1
• Filed: 12/18/2000
• Published: 09/13/2001
• Est. Priority Date: 03/11/1999
• Status: Active Grant

• Current Assignee: Guidant Corporation (Boston Scientific Corporation)
• Original Assignee: Guidant Corporation (Boston Scientific Corporation)
• Inventors: Colvan, William P., Peterson, Charles R., Thompson, Gary, Haldeman, Paul, Wilson, Bruce, Becker, Neil M., Armstrong, Kenneth K., Quinones, Albert A., Clarke, Duncan, Wilson, Victor, Tarver, LaShun D.
• Granted Patent: US 6,575,960 B2
• Time in Patent Office: Days
• US Class Current: 604/167.01
• 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. A spring, wound around the dilator, returns the funnel cap to its original position, thus closing the bleed back seal. The bleed back seal self-sizes to devices introduced through its aperture. Dilating the bleed back control seal also allows purging of gases or fluids. The clamp seal can clamp a device introduced transluminally to maintain device position, and the clamp seal may also be closed to allow high pressure injections.

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 said seal assembly and coupled to said proximal end of said side arm body, said cap assembly restraining said seal assembly within said seal cavity and providing user manipulation of said seal assembly and said cap assembly having a lumen having a proximal aperture communicating with the exterior of said cap assembly; and

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

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:

an axially movable 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 during operation of said assembly.

3. 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.

4. The bleed back control assembly of

claim 2

;

wherein said seal assembly further comprises;

a clamp seal abutting the interior distal surface of said seal cavity; and

said seal holder restrains said clamp seal within said seal cavity.

5. The bleed back control assembly of

claim 4

, wherein:

said clamp seal comprises a cylindrical body portion proximal to a tapered frustum portion, said cylindrical body portion and said frustum having a lumen;

said seal holder has legs proximal to said clamp seal, said legs retaining and compressing said cylindrical body portion of said clamp seal;

said frustum portion of said clamp seal conforms with the shape and size of the distal interior surface of said seal cavity;

said clamp seal is deformable when said legs compress said clamp seal to constrict said lumen of said clamp seal; and

wherein said clamp seal is formed of an elastomer.

6. 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.

7. 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.

8. The bleed back control assembly of

claim 4

, wherein said cap assembly comprises a threaded cap having a proximal surface and a center hole in said proximal surface, and said threaded cap is rotatably connected to said proximal end of said side arm body and is operable to open or close said seal clamp.

9. The bleed back control assembly of

claim 3

, 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.

10. 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 a return spring when moved distally;

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

11. The bleed back control assembly of

claim 4

, wherein said clamp seal and said bleed back control seal are formed of one integral part.

12. The bleed back control assembly of

claim 1

, further comprising a luer attached to said distal end of said side arm body.

13. The bleed back control assembly of

claim 2

, wherein said seal mechanism further comprises a tube for dilating said aperture,

said bleed back control seal further comprising ears forming a seal around the exterior surface of said tube.

14. The bleed back control seal of

claim 2

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

15. The bleed back control assembly of

claim 8

, wherein:

said threaded cap may be rotatably tightened to cause the lumen of said clamp seal to close, and

said clamp seal resists fluid pressure of up to at least 400 psi when said clamp seal is closed.

16. The bleed back control assembly of

claim 8

, further comprising:

a vascular intervention device intended for transluminal insertion into a patient, said vascular intervention device introduced into said cap assembly'"'"'s proximal aperture, through said threaded cap'"'"'s center hole, and into the lumen of said clamp seal, and

wherein rotation of said threaded cap causes said lumen of said clamp seal to constrict and clamp around said vascular intervention device.

17. 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.

18. The bleed back control seal 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.

19. 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 proximal to and holding said means for clamp sealing in position, said 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

means for dilating said aperture of said means for bleed back sealing.

20. A method for controlling blood loss in a bleed back control assembly, comprising:

introducing a vascular intervention device transluminally into a funnel cap of said bleed back control assembly,

inserting said vascular intervention device through an aperture in a bleed back control seal distal to said funnel cap and forming a bleed back seal conforming to the shape of said vascular intervention device,

inserting said vascular intervention device through the lumen of a side arm body distal to said bleed back control seal,

inserting said vascular intervention device into a patient'"'"'s body distal to said side arm body.