Dual valve, flexible expandable sheath and method

• US 6,197,016 B1
• Filed: 07/06/1999
• Issued: 03/06/2001
• Est. Priority Date: 12/13/1991
• Status: Expired due to Term

• Current Assignee: Lifeshield Sciences LLC (Acacia Research Corporation)
• Original Assignee: EndoVascular Technologies Incorporated (Boston Scientific Corporation)
• Inventors: Baker, Steven G., Fourkas, Michael G., Mitchell, David H.
• Primary Examiner(s): Kennedy, Sharon
• Assistant Examiner(s): RODRIGUEZ, CRIS LOIREN
• Application Number:
  US09/346,036
• Time in Patent Office: 609 Days
• Field of Search: 604/248, 604/171, 604/256, 604/523, 604/166.01, 604/170.01, 604/537, 604/167.01, 604/164.01, 604/165.01, 251/4, 251/345
• US Class Current: 604/537
• CPC Class Codes: A61B 17/3439 with means for changing the inner diameter of the cannula, e.g. expandable A61B17/3423, A61B17/3431 take precedence; catheters A61M25/0662
• CPC Class Codes: A61B 17/3462 with means for changing the diameter or the orientation of the entrance port of the cannula, e.g. for use with different-sized instruments, reduction ports, adapter seals expandable cannulas A61B17/3417
• CPC Class Codes: A61M 2039/062 used with a catheter
• 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 2039/0673 comprising means actively pressing on the device passing through the seal, e.g. inflatable seals, diaphragms, clamps
• CPC Class Codes: A61M 2039/0686 comprising more than one seal
• CPC Class Codes: A61M 25/0021 characterised by the form of the tubing A61M25/0054 takes precedence
• CPC Class Codes: A61M 25/0023 by the form of the lumen, e.g. cross-section, variable diameter
• CPC Class Codes: A61M 25/005 with embedded materials for reinforcement, e.g. wires, coils, braids
• CPC Class Codes: A61M 25/0053 having a variable stiffness along the longitudinal axis, e.g. by varying the pitch of the coil or braid
• CPC Class Codes: A61M 25/0075 Valve means
• CPC Class Codes: A61M 25/0662 Guide tubes
• CPC Class Codes: A61M 25/0668 splittable, tear apart
• 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 39/0613 with means for adjusting the seal opening or pressure A61M39/0693 takes precedence

Abstract

A large-diameter expandable sheath for use in introducing a catheter or other medical instrument into a vessel in the body of a patient. The expandable sheath comprises an elongate sheath tube formed of a flexible material which has proximal and distal extremities and a passage extending therethrough of a maximum predetermined diameter. The distal extremity of the elongate sheath tube is folded longitudinally to a smaller folded diameter. The sheath tube may be self-expanding or may be reinforced with a self-expanding wire or expandable stents. A backflow adapter is secured to the proximal extremity of the elongate sheath tube. The backflow adapter has a central opening therein in registration with the passage in the sheath tube. A normally closed primary valve is disposed in the central opening of the backflow adapter and is movable to an open position. A normally open secondary valve, movable to a closed position, may be configured in the backflow adapter proximal the sheath tube and distal the primary valve. The primary and secondary valves when open permit a catheter or other medical instrument to be inserted into the sheath.

Claims

1. A large-diameter expandable sheath for use in introducing a catheter into a corporeal vessel, comprising:

an elongate sheath tube formed of a flexible material having proximal and distal extremities and having a passage extending therethrough of a maximum predetermined diameter;

the distal extremity of said sheath tube being folded longitudinally to a smaller folded diameter;

a backflow adapter secured to the proximal extremity of said sheath tube;

said backflow adapter having a central opening therein in registration with the passage in said sheath tube and having a valve disposed in the central opening of said backflow adapter and movable between open and closed positions;

wherein the valve when open permits the catheter to be inserted into said sheath tube and when closed forms a hemostatic seal about the catheter;

wherein the valve is in the form of a cylindrical member formed of a flexible material and having a bore therein in registration with the central opening of said backflow adapter;

said backflow adapter having a rotatable device, said rotatable device configured to engage the opposite ends of the cylindrical member for causing relative rotation between the ends of the cylindrical member to cause the cylindrical member to be twisted to close the bore extending through the cylindrical member; and

said rotatable device includes a retaining ring, a sheath tube adapter secured to opposite ends of the cylindrical member, a fixing device that fixes the sheath tube adapter to prevent rotation of the same within said backflow adapter, and a first sub-component that rotates the retaining ring with respect to the sheath tube adapter.

2. The sheath of claim 1, wherein said rotatable device includes a ring gear secured to said retaining ring and a rack, said rack drives said ring gear to cause rotation of the same.

3. The sheath of claim 2, further comprising a yieldable device that engages said rack and urges said rack into a position wherein said cylindrical member is moved to provide a normally closed valve device.

4. The sheath of claim 3, wherein said rack extends tangentially through said body together with an actuator carried by the rack adapted to be engaged by the fingers of the hand that operates to move against the force of the yieldable device to move the normally closed valve device to an open position.

5. The sheath of claim 4, further comprising a stabilizer rod slidably mounted within said body parallel to said rack and secured to said actuator.

6. The sheath of claim 5, further comprising a second sub-component, said second sub-component carried by the rack and adapted to prevent said yieldable device from pulling said rack out of engagement with said cylindrical member.

7. A large-diameter expandable sheath for use in introducing a catheter into a corporeal vessel, comprising:

an elongate sheath tube formed of a flexible material having proximal and distal extremities and having a passage extending therethrough of a maximum predetermined diameter;

the distal extremity of said sheath tube being folded longitudinally to a smaller folded diameter;

a backflow adapter having a central opening therein in registration with the passage in said sheath rube and having a valve disposed in the central opening of said backflow adapter and movable between open and closed positions;

wherein the valve when open permits the catheter to be inserted into said sheath tube and when closed forms a hemostatic seal about the catheter; and

a sheath introducer disposed in the passage of said sheath tube to form an assembly, said sheath introducer having a distal extremity extending beyond the proximal extremity of said sheath tube and a dilator mounted on the distal extremity of said sheath introducer with has a diameter greater than the folded diameter of said sheath tube.

8. A large-diameter expandable sheath tube assembly for use in a corporeal vessel, comprising:

an elongate flexible sheath tube having proximal and distal extremities and having a passage extending therethrough of a maximum diameter;

a backflow adapter mounted on the proximal extremity of said sheath tube;

a sheath introducer disposed in said backflow adapter and extending through the passage in said sheath tube;

said sheath introducer comprising an elongate tubular member having a proximal extremity and a distal extremity having a reduced diameter from the proximal extremity;

the distal extremity of said sheath tube being folded over the distal extremity of the elongate tubular member of said sheath introducer to a folded diameter;

said sheath introducer having a sleeve that covers the folded distal extremity of said sheath tube to prevent the folded distal extremity of the sheath tube from causing trauma to the vessel when the sheath tube is introduced into the vessel;

a securing device that secures said sleeve on the elongate tubular member of said sheath introducer so that said sheath introducer can be pushed distally with respect to said sheath tube to cause said sleeve to be removed from the distal extremity of said sheath tube to permit said sheath tube to expand and to push the proximal extremity of said sheath introducer through the distal extremity of said sheath tube to expand said sheath tube; and

said securing device includes a length of shrink tubing extending over said sleeve and having a diameter greater than said sleeve.

9. The assembly of claim 8, further comprising a preventing device carried by the distal extremity of the sheath introducer to prevent the shrink tubing from being separated from the distal extremity of the sheath introducer.

10. A sheath tube introducer, comprising:

a flexible elongate tubular member having proximal and distal extremities;

a fitting positioned at the proximal extremity of said tubular member;

a sleeve positioned at the distal extremity of said tubular member;

said sleeve having a proximal expandable extremity and a distal extremity;

a securing device that prevents the distal extremity of said sleeve from being separated from the distal extremity of said tubular member; and

said securing device includes a length of shrink tubing mounted on said sleeve.

11. The sheath introducer of claim 10, wherein the proximal extremity of the flexible elongate tubular member is of greater diameter to provide additional rigidity to the flexible elongate tubular member and to provide a dilator that dilates the distal extremity of the sheath tube.

12. A sheath tube introducer, comprising:

a flexible elongate tubular member having proximal and distal extremities;

a fitting positioned at the proximal extremity of said tubular member;

a sleeve positioned at the distal extremity of said tubular member;

said sleeve having a proximal expandable extremity and a distal extremity;

a securing device that prevents the distal extremity of said sleeve from being separated from the distal extremity of said tubular member; and

said tubular member having a flow passage therein together with an opening formed in said tubular member proximal of the proximal extremity of said sleeve and in communication with the flow passage.

13. A backflow adapter having a body with a central opening in fluid communication with a sheath tube, comprising:

a first diaphragm disposed in the central opening of said backflow adapter, said first diaphragm having a first end and a second end and being movable between open and closed positions;

a first retainer that engages said first diaphragm for causing relative rotation between the ends of said first diaphragm;

a second diaphragm disposed in the central opening of said backflow adapter and adjacent the second end of said first diaphragm, said second diaphragm having a first end and a second end and being movable between open and closed positions; and

a second retainer that engages said second diaphragm for causing relative rotation between the ends of said second diaphragm.

14. The backflow adapter of claim 13, wherein said second retainer includes a gear secured to the second diaphragm and a rack for driving the gear to cause rotation of the second diaphragm.

15. The backflow adaptor of claim 14, wherein the second retainer further comprises a biasing device that urges the rack into a position wherein the second diaphragm is rotated to a closed position.

16. The backflow adaptor of claim 15, wherein the second retainer comprises an actuator carried by the rack for moving the rack against the force of the biasing device to move the second diaphragm to an open position.

17. The backflow adaptor of claim 16, wherein the second retainer further comprises a stabilizer rod slidably mounted parallel to the rack and secured to the actuator.

18. The backflow adapter of claim 17, further comprising a sheath tube adapter secured to the body of said backflow adapter and secured to a sheath tube so as to prevent rotation of said sheath tube adapter when either said first diaphragm or said second diaphragm are rotated within the body of said backflow adapter.