Percutaneous access device

• US 5,059,186 A
• Filed: 03/23/1989
• Issued: 10/22/1991
• Est. Priority Date: 03/07/1988
• Status: Expired due to Term

• Current Assignee: Vitaphore Corporation
• Original Assignee: Vitaphore Corporation
• Inventors: Yamamoto, Ronald K., Bootman, Matthew, Conston, Stanley R.
• Primary Examiner(s): Pellegrino, Stephen C.
• Application Number:
  US07/328,425
• Time in Patent Office: 943 Days
• Field of Search: 604/164-169, 604/256, 604/280, 604/283, 604/265, 604/175, 604/905, 128/656, 128/658
• US Class Current: 604/537
• CPC Class Codes: A61M 2039/062 used with a catheter
• CPC Class Codes: A61M 25/0111 Aseptic insertion devices
• CPC Class Codes: A61M 39/0613 with means for adjusting the seal opening or pressure A61M39/0693 takes precedence

Abstract

A percutaneous access device for aseptically introducing catheters or other tubes into the body, is disclosed. In one aspect, the device comprises a valve housing having a tapered inner bore; a tapered tubular valve means which is inserted into the valve housing bore and comprises one or two valves; and a valve cap which is screwed into the valve housing behind the valve. The valve means, housing and cap have bores along a common axis to permit the insertion of a tube such as a catheter through the device and into the body. The cap and valve housing cooperatively compress the valve means to selectively seal the valve bore about the catheter, close the valve bore when the catheter is removed, and provide anti-microbial wiping action of the catheter during insertion. The valve means may comprise two valves, a hemostatic sealing valve and an anti-bacterial squeegee valve which provides accelerated release of the anti-bacterial agent under mechanical compression. Alternatively, the two valves may comprise a first, convex hemispherical valve which provides an air reflux barrier and mechanical seal when the catheter is not present and a second, cylindrical valve compressed between the first valve and the locking cap for providing a compressively-enhanced long-term anti-bacterial mechanical sealing barrier when the cap is locked over the inserted catheter and anti-bacterial wiping action during insertion or removal of the catheter with the cap unlocked. In another alternative, the wiping/squeegee function and the sealing functions are cooperatively provided by a duck bill valve, and a cylindrical valve with an O-ring.

Claims

1. In a percutaneous access device having an intracorporeal adapted for aseptic leak-proof insertion therethrough of a tubular device such as a catheter, comprising the improvement:

valve means having a bore therein for receiving a tubular device, the valve means comprising a first valve proximally located to the point of insertion of said tubular device into body tissue, adapted for hemostatic sealing against the outside of the tubular device and a second valve impregnated with an antibacterial agent distally located to said point of insertion of said tubular device into body tissue, and adapted for sealing against the outside of the tubular device when said device is positioned within the bore of the valve means and wiping the tubular device during movement thereof along the bore of the valve means; and

a valve housing having a bore therein for receiving the tubular device and the valve means.

2. A percutaneous access device adapted for aseptic leak-roof insertion therethrough of a tubular device such as a catheter, comprising:

a tubular valve housing having first and second opposite ends and having a bore having at least an enlarged section extending from the first end to the second end thereof for receiving both a tubular body and valve means positioned over said tubular body;

tubular valve means having a bore therein fitting over said tubular body and comprising two interactive valves;

the first valve comprising a duck bill valve having first and second ends;

the first end of the duck bill valve being tapered; and

the second valve having first and second ends, the first end of the second valve being configured for complementarily mating with the second end of the first valve and the second end of the second valve being tapered;

the second valve further being formed of resilient polymer material selectively impregnated with an anti-microbial agent for providing compressive recharging of anti-microbial activity; and

a tubular valve cap having threads mating with the valve housing for releasably attaching the cap onto the second end of the valve housing and including a tapered section mating with the second tapered end of the second valve, for selectively compressing the second valve between the cap and the valve housing so that selection of the mounting position of the valve cap on the valve housing and the associated compression of the second valve effects at least one of resiliently sealing the valve about the tubular device, insertion of the tubular device through the valve, anti-bacterial wiping action along the device during insertion and providing a rechargeable anti-bacterial barrier on the tubular device.

3. A percutaneous access device adapted for aseptic insertion therethrough of a tubular device such as a catheter, and further adapted for resealing upon removal of said tubular device therefrom, comprising:

a tubular valve means formed of resilient polymer material selectively impregnated with an anti-microbial agent for providing compressive recharging of anti-microbial activity, the valve means further including an axial opening and having a tapered end;

a tubular valve housing having first and second opposite ends, including an intracorporeal tube attached at the first end thereof, and having a bore extending from the first end to the second end for receiving the tubular value means therein, the bore including a tapered section for mating with said tapered end of the tubular valve means; and

a tubular valve cap including means for releasably attaching the cap to the second end of the valve housing and selected positions thereon, for selectively compressing the tubular valve means between the cap and the valve housing, so that section of the position of the tubular cap on the valve housing is effective to provide for resilient sealing of the tubular valve means about the tubular device, insertion of the tubular device therethrough, rechargeable anti-bacterial wiping action along the tubular device during insertion, a rechargeable anti-bacterial barrier on the device upon insertion; and

for selectively compressing said tubular valve means between said cap and said valve housing upon removal of said tubular device so that selection of the position of said tubular cap on said valve housing is effective to seal with axial opening in said tubular valve means.

4. A device according to claim 3 wherein said valve means includes said tapered end as a first end and further includes a second tapered end opposite to said first end;

and said tubular valve cap includes a tapered section mating with said second tapered end of said valve means.

5. The percutaneous access device of claim 3 or 4 wherein the intracorporeal tube and the valve housing are separate elements, mutually adapted for attachable assembly.

6. The percutaneous access device of claim 3 or 4 wherein the intracorporeal tube and the valve housing comprise a single element.

7. The percutaneous access device of claim 3 or 4 wherein the intracorporeal tube includes a raised annulus of tissue in-growth promoting material for promoting a tissue seal and mechanical attachment to the skin.

8. A percutaneous access device adapted for aseptic leak-proof insertion therethrough of a tubular body such as a catheter comprising:

a tubular valve housing having first and second opposite ends and including a bore having at least an enlarged section extending from the first end to the second end thereof for receiving both the tubular body and valve means positioned over said tubular body;

tubular valve means comprising a cylindrical valve and an O-ring for wiping said tubular body during insertion and removal thereof, at least the O-ring being selectively impregnated with an anti-microbial agent; and

a valve cap, said cap and said housing having cooperating means for attaching said cap to said housing to secure the cylindrical valve within the housing to effect anti-microbial wiping action along the tubular body during insertion and removal thereof.

9. The percutaneous access device of claim 8, wherein the O-ring is an integral, internal, radially inwardly extending section of the cylindrical valve body.

10. The percutaneous access device of claim 9, the cooperating attachment means selectively positioning the valve cap along the housing to thereby adjustably compress the tubular valve means between the valve cap and the valve housing for effecting compression-enhanced anti-microbial sealing of the tubular valve means about the tubular body.

11. The percutaneous access device of claim 10, the tubular valve means further including, in front of the cylindrical valve, a valve member comprising a peripheral annular section and an inner, rearwardly-convex hemispherical body section within the peripheral section having a transverse slit therein;

the forward end of the cylindrical valve being configured such that the cylindrical valve and the valve member mate snugly one against the other;

both the cylindrical valve body and the valve member being formed of resilient polymer material.

12. The percutaneous access device of claim 8, wherein the O-ring is separate from the cylindrical valve.

13. The percutaneous access device of claim 8, further comprising a duck bill valve positioned in front of the cylindrical valve which incorporates the O-ring;

each of the duck bill valve, and the cylindrical valve having front and rear surfaces configured for mating snugly against the adjacent valve surfaces or intermediate spurs or washers;

the duck bill valve and cylindrical valve being formed of resilient polymer material.

14. A percutaneous access device adapted for aseptic leak-proof insertion therethrough of a tubular body such as a catheter comprising:

a tubular valve housing having first and second opposite ends and having a bore having at least an enlarged section extending from the first end to the second end thereof for receiving both the tubular body and valve means positioned over said tubular body;

tubular valve means fitting within the bore of said tubular valve housing and over said tubular body and comprising two valve members;

a first valve member comprising a peripheral annular section and an inner, outwardly-convex hemispherical body section within the peripheral section and having a transverse slit therein;

a second valve member comprising a cylindrical valve body having an internal radially-inwardly protruding ring section for wiping said tubular body during insertion and removal thereof and being sized for mating against the peripheral section of the first valve body; and

means for compressively sealing the valve bodies together against a shoulder formed within said bore of the tubular valve housing;

the first and second valve members being formed of resilient polymer material and the second valve member being selectively impregnated with an anti-microbial agent; and

a tubular valve cap, said cap and said housing having cooperating locking means for attaching said cap to said housing and selectively compressing the second and first valve members between the cap and the valve housing so that mounting the valve cap on the valve housing and associated compression of the second valve member effects a compression-enhanced anti-microbial seal of the second valve member about the tubular device and whereby said first valve provides a barrier against liquid leakage and air reflux when said tubular device is not present.

18. The percutaneous access device of any of claims 2, 3, 8, 14, 15 and 17, wherein the valve means is silicone and the anti-microbial agent is chlorhexidine.

19. The percutaneous access device of any of claims 2, 14, 15 and 17, further comprising an intracorporeal tube and wherein the intracorporeal tube and the valve housing are separate elements, mutually adapted for attachable assembly.

20. The percutaneous access device of claim 19, wherein the intracorporeal tube includes a raised annulus of tissue in-growth promoting material for promoting a tissue seal and mechanical attachment to the skin.

21. The percutaneous access device of any of claims 2, 8, 14, 15 and 17, further comprising an intracorporeal tube and wherein the intracorporeal tube and the valve housing comprise an integral component.

22. The percutaneous access device of claim 21, wherein the intracorporeal tube includes a raised annulus of tissue in-growth promoting material for promoting a tissue seal and mechanical attachment to the skin.

23. The percutaneous access device of claim 21, wherein the intracorporeal tube and the valve housing are joined by a ribbed pressure relief member.

15. A percutaneous access device adapted for aseptic leak-proof insertion therethrough of a tubular body such as a catheter, comprising:

a tubular valve housing having first and second opposite ends and having a bore having at least an enlarged section stepped to a smaller section at the first end, the bore extending from the first end to the second end thereof for receiving both the tubular body and valve means positioned over said tubular body;

tubular valve means fitting within the bore of said tubular valve housing and over said tubular body and comprising;

a front duck bill valve having a transverse slit for sealingly and slidably receiving said tubular body and having a front side configured for snugly mating against the stepped section of the bore;

a rear cylindrical valve having an inner bore slidably receiving said tubular body, the inner bore thereof incorporating an intrinsic O-ring having an internal diameter configured to effect wiping action along said tubular body during insertion and removal thereof;

the valves being formed of elastomeric material; and

the rear wiping valve being selectively impregnated with anti-microbial agent.

16. The percutaneous access device of claim 15, further comprising a spacer washer between the front duck bill valve and the rear cylindrical wiping valve.

17. A percutaneous access device adapted for aseptic leak-proof insertion therethrough of a tubular body such as a catheter, comprising:

a tubular valve housing having first and second opposite ends and having a bore having at least an enlarged section stepped to a smaller section at the first end, the bore extending from the first end to the second end thereof for receiving both the tubular body and valve means positioned over said tubular body;

tubular valve means fitting within the bore of said tubular valve housing and over said tubular body and comprising;

a front duck bill valve having a transverse slit for sealingly and slidably receiving said tubular body and having a front side configured for snugly mating against the stepped section of the bore;

a rear cylindrical valve having an inner bore slidably receiving said tubular body;

an O-ring intermediate the front duck bill valve and the rear cylindrical valve and having a hole therein of lesser diameter than the bore of the cylindrical wiping valve for effecting wiping action along said tubular body during insertion and removal thereof;

the valves being formed of elastomeric material; and

the rear cylindrical wiping valve being selectively impregnated with anti-microbial agent.