Access device maintenance apparatus and method

• US 20040093018A1
• Filed: 10/16/2002
• Published: 05/13/2004
• Est. Priority Date: 10/16/2002
• Status: Active Grant

• Current Assignee: Applied Medical Resources Corporation (Applied Medical Corporation)
• Original Assignee: Applied Medical Resources Corporation (Applied Medical Corporation)
• Inventors: Johnson, Gary M., Ahlberg, Russell E.
• Granted Patent: US 7,105,009 B2
• Time in Patent Office: Days
• US Class Current: 606/205
• CPC Class Codes: A61B 17/3498 Valves therefor, e.g. flapper valves, slide valves haemostasis valves A61M39/06; check valves A61M39/24

Abstract

A trocar includes a valve housing and cannula which define a working channel. A valve disposed in the valve housing along the working channel includes a gel material which defines a slit that functions as a zero seal in the absence of an instrument, and an instrument seal in the presence of an instrument. The slit is formed by mating gel components which are preferably separated during storage of the device. This separation can be facilitated by a pull strip which can be pre-lubricated and inserted into the slit for ultimate removal prior to activation of the trocar.

Claims

1. A medical access device having a stored state and an active state, and being formed with a working channel adapted to provide access through the device and into a body conduit, comprising:

an access valve disposed along the working channel;

a first compliant material included in the access valve;

a second material included in the access valve in an opposing relationship with the first material;

the first material and the second material defining a slit extending through the access valve along the working channel;

the slit in the active state of the device being normally closed with the first material contacting the second material;

a strip disposed in the slit to inhibit the contacting relationship of the first material and the second material-in the stored state of the device, the strip being removable from the slit to initiate the active state.

2. The medical access device recited in claim 1, wherein the second material is a compliant material.

3. The medical access device recited in claim 2, wherein the second material is the same as the first material.

4. The medical access device recited in claim 1, wherein the strip has properties for lubricating at least one of the first material and the second material when the strip is removed from the slit.

5. The medical access device recited in claim 4, wherein the strip comprises:

a first area adapted to be disposed between the first material and the second material when the device is in the stored state;

a second area adapted to be disposed distally of the slit when the device is in the stored state; and

a lubricant carried by the second area of the strip;

whereby

removal of the strip proximally deposits the lubricant on at least one of the first material and the second material.

6. The medical access device recited in claim 3, wherein the first material is a gel.

7. The medical access device recited in claim 1, wherein the strip comprises at least one of fabric, felt, paper, open-cell foam, closed-cell foam, Mylar, Tyvek, polytetrafluorethylene, and nylon.

8. A medical access device having a working channel adapted to provide access for a medical instrument into a body conduit, comprising:

an access valve disposed along the working channel and adapted to form an instrument seal with the instrument when the instrument is in the working channel;

a pair of mating seal components defining the working channel through the access valve, the seal components having a tendency to form a bond when left in contact; and

removable means for separating the seal components to inhibit formation of the bond when the device is not in use.

9. The medical access device recited in claim 8, wherein the separating means is removable from between the seal components to activate the device.

10. The medical access device recited in claim 9 wherein at least one of the seal components includes a gel.

11. The medical access device recited in claim 9, wherein the separation means comprises:

strip means for separating the seal components;

lubrication means carried by the strip means for lubricating at least one of the seal components during removal of the separation means from between the seal components.

12. The medical access device recited in claim 11, wherein the lubricating means comprises at least one of, silicone grease, mineral oil, glycerin, water, petrolatum, propylene glycol, and Astroglide, a registered trademark of BioFilm, Inc.

13. The medical access device recited in claim 11, wherein the strip means comprises at least one of fabric, felt, paper, open-cell foam, closed-cell foam, Tyvek, Mylar, polytetrafluorethylene, and nylon.

14. The medical access device recited in claim 11, wherein:

portions of the strip means define at least one reservoir; and

the lubricating means is disposed in the reservoir.

15. A method for facilitating formation of an instrument seal using a medical access device adapted to receive a medical instrument, the access device having an access valve with a proximal side and a distal side, comprising the steps of:

providing the access valve with a first element and a second element disposed in a normally contacting relationship with the first element, the second element defining with the first element an opening to receive the medical instrument, the opening extending from the proximal side of the access valve to the distal side of the access valve;

separating the first element from the second element to inhibit the normal contacting relationship of the first element and the second element during a period of non-use; and

inhibiting the separating step to prepare the access device for receipt of the instrument.

16. The method recited in claim 15, wherein the separating step includes the step of:

occupying at least a portion of the slit with a third element in order to separate the first element from the second element.

17. The method recited in claim 16, wherein the occupying step includes the step of:

providing a strip; and

inserting the strip into the access device to extend through the slit between the proximal side and the distal side of the access device.

18. The method recited in claim 17, wherein the inhibiting step includes the step of:

removing the strip from the slit to facilitate the normal contacting relationship of the first element and the second element of the access device.

19. The method recited in claim 18, wherein the step of providing the strip includes the step of:

coating the strip with a lubricant.

20. The method recited in claim 19, wherein the step of removing the strip includes the steps of:

pulling the strip proximally from the slit; and

during the pulling strip, depositing the lubricant on at least one of the first element and the second element of the access device.

21. A method for facilitating formation of an instrument seal using a medical access device adapted to receive a medical instrument, comprising the steps of:

providing an access valve having a pair of complimenting seal components defining a proximal side and a distal side of the access valve, the seal components being adapted to form the instrument seal with the instrument;

providing a lubrication strip with a lubricant disposed in proximity to a distal end of the strip;

positioning the lubricating strip to extend between the seal components with the distal end of the strip extending distally of the distal side of the access valve;

removing the strip from between the seal components; and

during the removing step depositing the lubricant on the access valve.

22. The method recited in claim 21, further comprising the steps of:

inserting the instrument between the seal components to form the instrument seal.

23. The method recited in claim 22, wherein the lubricant is a first lubricant and the method further comprises the step of:

coating the instrument with a second lubricant; and

during the inserting step depositing the second lubricant on the access valve.

24. The method recited in claim 23, wherein:

the removing step includes the step of depositing the first lubricant on the distal side of the access valve; and

the inserting step includes the step of depositing the second lubricant on the proximal side of the access valve.

25. A method for inserting a flexible separation strip between seal components in a medical access device having a working channel extending between a proximal end and a distal end, including the steps of:

forming the strip with a narrow distal end and an enlarged proximal end;

inserting a grasper into the working channel and between the seal components;

grasping the strip with the grasper;

withdrawing the grasper from the working channel; and

during the withdrawing step, pulling the strip in through the working channel and between the seal components of the access device.

26. The method recited in claim 25, wherein the grasping step includes the step of:

grasping the distal end of the strip.

27. The method recited in claim 26, wherein the inserting step includes the step of:

inserting the grasper from the distal end of the access device toward the proximal end of the access device.

28. The method recited in claim 25, further comprising the steps of:

prior to the pulling step, lubricating the distal end of the strip.