Hemostasis valve apparatus with integral introducer

• US 6,287,280 B1
• Filed: 09/07/1999
• Issued: 09/11/2001
• Est. Priority Date: 09/07/1999
• Status: Expired due to Term

• Current Assignee: Merit Medical Systems, Inc.
• Original Assignee: Merit Medical Systems, Inc.
• Inventors: Lampropoulos, Fred P., Stevens, Brian W.
• Primary Examiner(s): Seidel, Richard K.
• Assistant Examiner(s): MAYNARD, JENNIFER J
• Application Number:
  US09/390,822
• Time in Patent Office: 735 Days
• Field of Search: 604/246, 604/164.01, 604/164.02, 604/165.01, 604/167.01, 604/167.02, 604/167.03, 604/167.04, 604/167.06, 604/256
• US Class Current: 604/167.03
• CPC Class Codes: A61M 39/0693 including means for seal penetration

Abstract

A valve system configured to access the cardiovascular system of a patient includes: (i) a valve body having a lumen therethrough; (ii) a selectively openable resilient first seal, (iii) a compressible second seal including an opening which communicates with the lumen when the second seal is in an open position; (iii) a locking nut movably coupled to the valve body, the locking nut configured to selectively increase and decrease compressive force on the second seal; and (iv) an introducer configured to selectively open the resilient first seal. The introducer has a proximal end and a distal end. The introducer is movably coupled to the locking nut and reciprocates between a first position and a second position within the locking nut. The resilient first seal is in the closed position when the introducer is in the first position and the resilient first seal is in the open position when the introducer is in the second position. The introducer protects elongate instruments such as catheters having stents thereon while the instruments are moved through the resilient seal while the seal is opened by the introducer.

Claims

1. A hemostasis valve apparatus for preventing blood loss while permitting introduction of a guidewire, a catheter for placement of a stent or balloon, and similar intravascular instruments for diagnostic and interventional procedures, tile apparatus comprising:

a valve body comprising a lumen which runs therethrough for purposes of permitting a vascular instrument to be introduced into a patient'"'"'s vascular system;

a first means for scaling, situated within said valve body, for forming a first normally closed valve member across the lumen of said valve body;

a second means for scaling, situated within said valve body, for forming a second normally open valve member across the lumen of said valve body, and which is selectively closeable by exertion of a compressive force thereon;

compressive means, joined to the valve body and forming an assembly therewith which together encloses the first and second means for sealing within the assembly, for selectively exerting and removing a compressive force applied to said second means for sealing so as to selectively close and open the second means for scaling about the circumference of a vascular instrument in response to the exertion and removal of said force, respectively, and

introducer means for providing a protective pathway through which a vascular instrument passes unobstructed, said introducer means being slidably moveable between a first position in which the protective pathway is fully withdrawn from the first means for sealing to permit sealing across the lumen of the valve body, and a second position in which the protective pathway extends across and through the first means for sealing, movement of the introducer means and operation of the compressive means being independent of one another so that the compressive means is operable to selectively open and close the second means for sealing independent of whether the introducer means is in the first or second position, and so that the introducer means is moveable to the first or second position independent of whether the compressive means is operated to close the second means for sealing or is operated to open the second means for sealing.

2. A valve apparatus as recited in claim 1, wherein the compressive means comprises a locking nut.

3. A valve system as recited in claim 2, wherein the first means for sealing and the second means for scaling are positioned within said lumen, and wherein the first means for sealing is situated between said introducer means and said second means for sealing.

4. A valve system as recited in claim 1, wherein the introducer means is telescopically coupled to the compressive means.

5. A valve as recited in claim 1, wherein the first means for scaling comprises a slit valve.

6. A valve as recited in claim 1, wherein the compressive means comprises a rotatable locking nut which has an opening therein and wherein the introducer means is telescopically situated within said opening so as to selectively reciprocate within the opening.

7. A apparatus as recited in claim 1, further comprising means for selectively locking the introducer means in the second position.

8. A hemostasis valve apparatus for preventing blood loss while permitting introduction of a guidewire, a catheter for placement of a stent or balloon, and similar intravascular instruments for diagnostic and interventional procedures, the apparatus comprising:

a valve body comprising a lumen which runs therethrough for purposes of permitting a vascular instrument to be introduced into a patient'"'"'s vascular system;

a normally closed resilient seal, situated within said valve body across the lumen of said valve body;

a normally open compressible seal, situated within said valve body across the lumen of said valve body, and which is selectively closeable when deformed by exerting a compressive force on the compressible seal;

a rotatable locking nut, joined to the valve body and forming an assembly therewith which together encloses the resilient and the compressible seals within the assembly, the locking nut being rotatable about the valve body to selectively exert and remove a compressive force applied to said compressible seal so as to selectively close and open the compressible seal about the circumference of a vascular instrument in response to the exertion and removal of said force, respectively; and

an elongated, hollow introducer through which a vascular instrument passes unobstructed, the introducer being telescopically joined to said rotatable locking nut so as to form part of said assembly, and said introducer being slidably moveable between a first position in which the introducer is fully withdrawn from the resilient seal to permit closure and sealing by the resilient seal, and a second position in which a portion of the introducer extends across and through the normally closed resilient seal, movement of the introducer and movement of the rotatable locking nut being independent of one another so that the locking nut is moveable to selectively open and close the compressible seal independent of whether the introducer is in the first or second position, and so that the introducer is movable to the first or second position independent of whether the locking nut is rotated to close the compressible seal or is rotated to open the compressive seal.

9. A valve apparatus as recited in claim 8, wherein the resilient and compressible seals are located within the valve body.

10. A valve as recited in claim 8, wherein the introducer is telescopically moveable within the locking nut.

11. A valve as recited in claim 8, wherein the introducer comprises a tubular body and a funnel-shaped hub coupled to and in fluid communication with the tubular body.

12. A valve as recited in claim 8, wherein the locking nut is rotatably coupled to the body and wherein the introducer is movably coupled to the locking nut and reciprocates back and forth within an opening of the locking nut.

13. An apparatus as recited in claim 8 wherein the resilient seal comprises means for selectively locking the introducer in the second position.

14. A hemostasis valve apparatus for preventing blood loss while permitting introduction of a guidewire, a catheter for placement of a stent or balloon, and similar intravascular instruments for diagnostic and interventional procedures, the apparatus comprising:

a valve body comprising a lumen which runs therethrough for purposes of permitting a vascular instrument to be introduced into a patient'"'"'s vascular system;

a sealing means, situated within said valve body, for forming a normally open valve member across the lumen of said valve body, and which is selectively closeable by exertion of a compressive force thereon;

compressive means, joined to the valve body and forming an assembly therewith which together encloses the means for sealing within the assembly, for selectively exerting and removing a compressive force applied to said means for sealing so as to selectively close and open the means for sealing about the circumference of a vascular instrument in response to the exertion and removal of said force, respectively; and

introducer means for providing a protective pathway through which a vascular instrument passes unobstructed, said introducer means being slidably moveable between a first position in which the protective pathway is fully withdrawn from the sealing means, and a second position in which the protective pathway extends essentially up to but not through the sealing means, movement of the introducer means and operation of the compressive means being independent of one another so that the compressive means is operable to selectively open and close the sealing means independent of whether the introducer means is in the first or second position, and so that the introducer means is moveable to the first or second position independent of whether the compressive means is operated to close the scaling means or is operated to open the sealing means; and

means for selectively locking the introducer means in the second position.

15. A valve as described in claim 14, further comprising a second sealing means, situated within said valve body, for forming a normally closed valve member across the lumen of said valve body, said second scaling means being positioned between said introducer means and said sealing means for forming a second normally opened valve member.

16. A valve apparatus as defined in claim 15 wherein said second sealing means is comprised of a resilient membrane having at least one slit formed in the membrane, and wherein the said at least one slit provides the means for selectively locking the introducer means in the second position.

17. A hemostasis valve apparatus for preventing blood loss while permitting introduction of a guidewire, a catheter for placement of a stent or balloon, and similar intravascular instruments for diagnostic and interventional procedures, the apparatus comprising:

a valve body comprising a lumen which runs therethrough for purposes of permitting a vascular institute to be introduced into a patient'"'"'s vascular system,

a normally open compressible seal, situated within said valve body across the lumen of said valve body, and which is selectively closeable when deformed by exertinig a compressive force on the compressible seal;

a rotatable locking nut, joined to the valve body and forming an assembly therewith which together encloses the compressible seal within the assembly, the locking nut being rotatable about the valve body to selectively exert and remove a compressive force applied to said compressible seal so as to selectively close and open the compressible seal about the circumference of a vascular instrument in response to the exertion and removal of said force, respectively; and

an elongated, hollow introducer through which a vascular instrument passes unobstructed, the introducer being telescopically joined to said rotatable locking nut so as to form part of said assembly, and said introducer being slidably moveable between a first position in which the introducer is withdrawn away from the compressible seal, and a second position in which the introducer is inserted so as to extend essentially up to the opening of the normally open compressible seal, movement of the introducer and movement of the rotatable locking nut being independent of one another so that the locking nut is movable to selectively open and close the compressible seal independent of whether the introducer is in the first or second position, and so that the introducer is movable to the first or second position independent of whether the locking nut is rotated to close the compressible seal or is rotated to open the compressible seal, and

means for selectively locking the introducer in the second position.

18. A valve apparatus as defined in claim 17, further comprising a normally closed resilient seal, situated within said valve body across the lumen of said valve body, and located between said hollow introducer said the normally open compressible seal.

19. A valve apparatus as defined in claim 18 wherein the normally closed resilient seal is comprised of a resilient membrane and at least one slit formed in the membrane, and wherein said at least one slit serves as the means for selectively locking the introducer in the second position.