Packaged precision-lubricated ready-to-use intermittent urinary catheter
A method of packaging a ready to use intermittent urinary catheter by (i) placing lubricant within a pocket formed in a base film proximate a first end of the pocket, (ii) placing a catheter within the pocket with the insertion end of the catheter proximate the first end of the pocket, (iii) partially sealing the catheter within the pocket between the base film and a cover film, (iv) pulling a vacuum within the pocket to effect controlled circumferential flow of lubricant around the insertion end portion of the catheter, and then (v) fully sealing the pocket.
1. A method of hermetically packaging an intermittent urinary catheter having an insertion end, an insertion end length defining an exterior surface area, a fixture end, and a fixture end length, comprising the steps of:
(a) obtaining a base film having a pocket with a first end and a second end, wherein the pocket is configured to retain the intermittent urinary catheter with the insertion end proximate the first end and the fixture end proximate the second end,
(b) injecting a limited amount of lubricant into the pocket proximate the first end of the pocket so as to form a lubricant containing pocket,
(c) placing the intermittent urinary catheter into the lubricant containing pocket so as to form a catheter containing pocket, with the insertion end of the intermittent urinary catheter proximate the first end and the fixture end of the intermittent urinary catheter proximate the second end,
(d) sealing a cover film to the base film with an unsealed opening proximate the second end of the pocket so as to form an enclosed catheter containing retention chamber accessible through the opening,
(e) drawing a vacuum on the enclosed catheter containing retention chamber through the opening sufficient to compress the retention chamber and cause lubricant to circumferentially flow around and coat a portion of the exterior surface area of the insertion end length of the catheter within the retention chamber without reaching and coating the fixture end length of the catheter within the retention chamber, and thereafter
(f) sealing the opening so as to form a hermetically packaged intermittent urinary catheter having a circumferentially lubricated insertion end length and a lubricant-free fixture end length.
2. The method of claim 1 wherein the intermittent urinary catheter has a profile and the pocket has a profile conforming to the profile of the intermittent urinary catheter.
3. The method of claim 1 wherein an alpha length of the intermittent urinary catheter is placed atop and into fluid contact with the lubricant within the pocket in step (c) and the vacuum is sufficient to effect a circumferential flow of lubricant around the alpha length so as to coat at least 70% of the external surface area of the alpha length of the catheter.
4. The method of claim 3 wherein the vacuum is sufficient to effect a circumferential flow of lubricant around the alpha length so as to coat at least 90% of the external surface area of the alpha length of the catheter.
5. The method of claim 3 wherein the alpha length is between 30% and 90% of the insertion end length of the catheter.
6. The method of claim 3 wherein the alpha length is between 50% and 80% of the insertion end length of the catheter.
7. The method of claim 3 wherein the alpha length is between 40% and 60% of the insertion end length of the catheter.
8. The method of claim 1 wherein the lubricant has a viscosity of between 15,000 and 500,000 centipoise at 72° F.
9. The method of claim 1 wherein the lubricant has a viscosity of between 15,000 and 50,000 centipoise at 72° F.
10. The method of claim 1 wherein the lubricant has a viscosity of between 100,000 and 400,000 centipoise at 72° F.
11. The method of claim 1 wherein the cover film is heat sealed to the base film in step (d).
12. The method of claim 1 wherein the opening is heat sealed.
13. The method of claim 1 wherein the cover film is a planar sheet.