Catheter introducer sheath assembly

• US 5,397,310 A
• Filed: 03/01/1993
• Issued: 03/14/1995
• Est. Priority Date: 10/11/1991
• Status: Expired due to Term

• Current Assignee: Lifescreen Sciences LLC (Acacia Research Corporation)
• Original Assignee: Boston Scientific Corporation
• Inventors: El-Nounou, Fozan O., Daigle, James B., Chin, Yem, Cragg, Andrew H., Chu, Michael S. H.
• Primary Examiner(s): Mancene, Gene
• Assistant Examiner(s): Lucchesi, Nicholas D.
• Application Number:
  US08/024,789
• Time in Patent Office: 743 Days
• Field of Search: 604/158, 604/164, 604/167, 604/169, 604/256, 604/905, 604/246, 604/248, 251/4, 251/6
• US Class Current: 604/158
• CPC Class Codes: A61M 2025/09125 Device for locking a guide wire in a fixed position with respect to the catheter or the human body
• CPC Class Codes: A61M 39/0613 with means for adjusting the seal opening or pressure A61M39/0693 takes precedence

Abstract

A catheter introducer sheath assembly, for introduction into a body passage of a catheter containing a filter comprises a flexible introducer sheath joined to the distal end of a closure device forming a through-passage with a diameter sufficient to pass the catheter therethrough. The closure device has a resilient member in the through-passage and two rotatable body portions, one stationary with respect to the resilient member, and the other rotatable about the axis of the resilient member with an internal cam circumferentially spaced around the axis. A compression member positioned radially in an extending aperture makes contact with both the resilient member and the cam surface to vary the through-passage allowing the operator to manually control the passage of the device. The sheath assembly receives a cathetory guidewire that slides through and extends beyond the closure device and the sheath. In another aspect, the combination sheath assembly and closure device forms a catheter introducer kit constructed to receive a stabilizer and a catheter of sufficiently large diameter to house a vena cava filter, and to pass the filter through the closure device and sheath for placement in the body by means of a dilator attached to the end of the sheath to facilitate guiding the filter to the desired position for its release from the sheath. The closure device is adjustable to prevent any backflow of fluid such as blood from the assembly during the filter placement procedure.

Claims

1. A catheter introducer kit comprising in combination a catheter introducer sheath assembly and a catheter containing a vena-cava filter and a stabilizer for placement of said filter, said catheter introducer sheath assembly comprising the combination of an elongated, flexible introducer sheath defining a passage and a closure device having a through passage extending between proximal and distal ends, said introducer sheath joined to the distal end of said closure device, the passages through said sheath and said closure device having a diameter sufficient to pass said catheter therethrough, said closure device comprising the combination of a resilient member at least partially defining said throughpassage of said closure device, said throughpassage having an axis;

a body including first and second relatively rotatable body portions, said first body portion being stationary with respect to said resilient member and said second body portion including an internal cam having a cam surface oriented about and spaced from the axis of said throughpassage with a first surface portion disposed relatively closer to said axis than a circumferentially spaced second surface portion; and

a compression member positioned in a radially extending aperture in said first body portion and biased radially outward by said resilient member to maintain contact with said cam surface,

said members of said combination of said closure device cooperatively related to enable adjustment of the radial compression of said resilient member for closing or opening said passage by relative rotation of said second body portion with respect to said first body portion to position, in dependent manner, said compression member radially closer to or further from said axis to close or open said throughpassage or to engage, with desired tightness, the said catheter or a guidewire extending or sliding through said closure device and sheath.

2. The kit of claim 1 wherein said passages through said closure device and said attached sheath are sized to pass a catheter containing a vena cava filter and a stabilizer wire for placement of the filter.

3. The kit of claim 2 wherein said passages are of the order of 5/8 inch diameter.

4. The kit of claim 1, 2 or 3 wherein said compression member is adjustable by manual manipulation of said second body portion to selected intermediate rotatable positions relative to said first body portion to cause said resilient member to lightly engage the sides of said catheter being inserted through said catheter introducer sheath assembly to impede outward blood flow along the sides of said catheter while permitting slidable insertion thereof.

5. The kit of claim 1 in combination with a removable elongated dilator disposed in said sheath, said dilator having a tapered distal portion extending distally beyond the sheath.

6. The kit of claim 5 wherein said dilator has a small axial passage enabling said dilator, sheath and closure device to be slid over a pre-placed guidewire for guiding the sheath into a predetermined position.

7. The catheter introducer kit of claim 1 including a dilator, said dilator having a small axial passage enabling said dilator, sheth and closure device to be slid over a pre-placed guidewire for guiding the sheath into a predetermined position.

11. The device of claim 1 or 8 wherein said compression member is a single ball-form member.

12. The device of claim 1 or 8 wherein said second rotatable body portion includes a first stop member which is engaged by said compression member and prevents disassembly of said body portions by blocking further relative rotation of said body portions.

13. The device of claim 1 or 8 wherein the closure device further includes a side channel distal of the axial position of the compression member.

14. The device of claim 1 or 8 wherein said second rotatable body portion has an external surface exposed for engagement and rotatable operation by the hand of a user.

8. A catheter introducer sheath assembly comprising the combination of an elongated, flexible introducer sheath defining a passage and a closure device having a through passage extending between proximal and distal ends, said introducer sheath joined to the distal end of said closure device, the passage through said sheath and the throughpassage through said closure device having diameters sufficient to pass a respective catheter therethrough,

said closure device comprising the combination of a resilient member at least partially defining said throughpassage of said closure device, said throughpassage having an axis;

a body including first and second relatively rotatable body portions, said first body portion being stationary with respect to said resilient member and said second body portion including an internal cam having a cam surface oriented about and spaced from the axis of said throughpassage with a first surface portion disposed relatively closer to said axis than a circumferentially spaced second surface portion; and

a compression member positioned in a radially extending aperture in said first body portion and biased radially outward by said resilient member to maintain contact with said cam surface,

said members of said combination of said closure device cooperatively related to enable adjustment of the radial compression of said resilient member for closing or opening said throughpassage by relative rotation of said second body portion with respect to said first body portion to position, in dependent manner, said compression member radially closer to or further from said axis to close or open said throughpassage or to engage, with desired tightness, a catheter or guidewire extending or sliding through said closure device and sheath and

wherein said cam defines a smooth spiral-form surface.

9. The device of claim 8 wherein a stop surface is defined at the end of said second cam surface portion arranged to engage said compression member and stop relative motion apart of said body portions when said compression member reaches a passage-opening position and said first and second body portions are further constructed to engage each other and stop threaded-together motion when said compression member reaches a passage-closing position.

10. The device of claim 9 wherein said first surface portion of said cam positions said compression member radially to completely close in fluid-tight manner said throughpassage and said second surface portion positions said compression member to fully open said throughpassage for fluid flow.

15. The device of claim 8 wherein said first body portion fixes the position of said resilient member and a second body portion, carrying said cam surface, is mounted to rotate upon said first body portion.

16. The device of claim 8 where said resilient member comprises a section of tubing comprised of silicone elastomer.

17. The device of claim 8 wherein said second rotatable body portion is axially and rotatably positioned by a screw thread.

18. The device of claim 8 wherein said compression member is held axially fixed, relative to said resilient member.

19. The device of claim 8 wherein a stationary body portion holds said resilient member in fixed relation and defines a radially extending aperture in which said compression member is axially confined, and permitted to move radially against said resilient member.

20. The device of claim 8 wherein said resilient member comprises a tubing member compressed axially and confined radially for sealing engagement of surfaces at its proximal and distal ends.

21. The device of claim 8 constructed so that said rotation of said second body portion to open and close said throughpassage is substantially one-half turn.

22. The device of claim 8 wherein said resilient member and the part of any body portion that overlies said resilient member comprise clear plastic material enabling visual examination of flow through said throughpassage.

23. The device of claim 8 wherein said first and second body portions are formed of moldable material.