WO2001052763A1

WO2001052763A1 - Catheter package and method

Info

Publication number: WO2001052763A1
Application number: PCT/US2000/021575
Authority: WO
Inventors: John H. Golden
Original assignee: Medical Technologies Of Georgia, Inc.
Priority date: 2000-01-19
Filing date: 2000-08-08
Publication date: 2001-07-26
Also published as: AU2000267608A1

Abstract

A catheter package (10) and method is provided with an envelope (12) containing a catheter (11) which has a lubricious coating activated by water or other suitable liquids. A burstable liquid pouch (17) is positioned within the envelope to enable the user to apply the liquid to the catheter coating while the catheter remains in a sterile condition within the envelope, without the necessity of touching or exposing the liquid or catheter prior to insertion.

Description

CATHETER PACKAGE AND METHOD

FIELD OF THE INVENTION

This invention relates to catheters and more particular to catheter packages containing a burstable liquid pouch for activating the catheter surface while maintaining the catheter is a contaminant free condition.

DESCRIPTION OF THE PRIOR ART AND OBJECTIVES OF THE INVENTION

Various types of catheters have been commercialized in the past for self-catheteπzation as set forth in U.S. Patent No.

5,209,726. Also, many types of lubricious hydrophilic coatings for catheters have been used such as set forth in U.S. Patent

No. 5,331,027. In addition, catheter packages containing breakable liquid pouches have been known such as the "EASICATH" of Coloplast A/S of Humlebaek, Denmark. In this device a plastic vial or bottle is provided having a snap-off top to release the liquid contents for activating the catheter coating. The snap-off top requires manual dexterity to both open the vial and prevent the edges so formed from piercing the outer package walls . Another commercially available item is sold by Astra Tech AB of Molndale, Sweden under the name

"Lofric Hydro Kit". Here a liquid pouch is contained within a catheter package but requires the liquid pouch to be removed before opening with a peel strip. The liquid pouch is then placed so the liquid contained therein will flow into a separate poly bag containing a catheter. The system is therefore only partially closed, increasing the possibility of contaminants entering as the liquid pouch is inserted in the catheter poly bag.

Thus, with the potential problems and dangers arising from prior art catheter packages, the present invention was conceived and one of its objectives is to provide a catheter package in which the catheter surface is easily activated with a provided liquid upon demand, while remaining in a sterile, non-contaminated condition.

It is another objective of the present invention to provide a self-lubricating catheter and method in which the catheter can be easily activated with a liquid without the need of precise manual manipulations for the activation process.

It is still another objective of the present invention to provide a catheter package and method in which the envelope can act as an extension for the catheter for draining purposes.

It is yet another objective of the present invention to provide a catheter which can be readily, manually manipulated during insertion from outside the package, thus lessening the possibility of contamination.

Various other objectives and advantages of the present invention will become apparent to those skilled in the art as a more detailed description is set forth below.

SUMMARY OF THE INVENTION

The aforesaid and other objectives are realized by providing a catheter such as a urethral catheter packaged in an envelope formed from polyethylene or other polymeric materials and in which the catheter has an external surface treated with a conventional polymer substance which will, upon contact with a suitable liquid such as water, become lubricious to assist in the insertion process for example, as used in draining urine from the bladder. The envelope also includes a liquid pouch containing a desired liquid such as distilled water for activation and which is easily burstable by the application of external, manual pressure. By applying pressure the liquid contained therein escapes and floods the catheter. Once the catheter has been saturated the envelope can then be opened and by manipulating the catheter through the envelope, the catheter remains in a clean condition during insertion. Several embodiments of the catheter package are provided which allow the user to flood the catheter with the contained liquid without exposing the catheter or liquid to external contaminants . The method for using the packaged catheter embodiments is also provided which prevents contamination and assists in the catheter activation and insertion process.

BRIEF DESCRIPTION OF THE DRAWINGS

Fig. 1 shows a top plan view of the preferred embodiment of the catheter package with the liquid pouch attached at the right end;

Fig. 2 features a view of the right end of the catheter package as shown in Fig. 1 but torn away with the spent liquid pouch still attached;

Fig. 3 depicts a second embodiment of the catheter package with the liquid pouch contained within but unattached; and

Fig. 4 shows the right end of the catheter package as seen in Fig. 3 torn away;

DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENTS AND OPERATION OF THE INVENTION

For a better understanding of the invention and its operation, turning now to the drawings, Fig. 1 demonstrates the preferred form of the invention with catheter package 10 containing conventional urethral catheter 11 within transparent envelope 12. Envelope 12 has a bottom layer 13 and a top layer 14 formed from a conventional polymeric material such as polyethylene or spun bonded olefin sheeting e.g., Tyvek, (a trademark of E. I. DuPont De Nemours and Company of Wilmington, Delaware). Liquid pouch 17 as shown in Fig. 1 may contain for example twenty milliliters of distilled water or other sterile wetting solution or liquid such as a saline solution to selectively activate the outer surface of catheter 11 which has been coated with a conventional hydrophilic coating as is well known in the industry. Such coatings may include a hydrophilic polyolefin such as polyvinyl-pyrrolidone ( PVP ) and cellulose esters or other polymers having suitable hydrophilic properties. Bottom layer 13 and top layer 14 are maintained under clean room conditions during manufacture and are joined preferably by heat sealing or adhesives around the edges as is standard in the trade. As distilled water or other liquid from liquid pouch 17 contacts hydrophilic coating on catheter 11, it becomes very lubricious, providing convenience and ease of insertion to the user.

Liquid pouch 17 may be formed from for example a polyethylene film, a polyester film or other polymeric materials or combinations thereof. Liquid pouch 17 is rupturable by applying moderate manual external pressure thereto such as by placing catheter package 10 on a table, sink or other rigid surface and pushing downwardly with the hand or elbow on top layer 14. Liquid pouch 17 may be prepared to conveniently burst with moderate pressure such as by forming a weakened or peelable seal around the perimeter, the latter being achieved via the use of a combination polyethylene/polyester film and other films in combination to form the top and bottom layers having different physical characteristics, causing them to easily delaminate when pressure is applied. Likewise, liquid pouch 17 may be rendered easily burstable by weakening areas along the top such as along line 18 as shown in Fig. 1. Weakened area 18 may be formed by providing areas therealong by alternating as thick and thin areas with the thin areas having a thickness of approximately one-half that of the thick area, during manufacture.

In the method of use, pressure is applied externally to liquid pouch 17 as hereinbefore explained causing the liquid therein to escape into chamber 19 which extends substantially the entire length of envelope 12. With catheter package 10 held in a vertical position with liquid pouch 17 at the top, liquid passes by gravity through chamber 19 and enters chamber reservoir 20 as seen in Fig. 1 past catheter tip 21. The lubricious coating of catheter 11 is then activated by the liquid and catheter 11 is then slick and ready for usual insertion .

Pouch 17 which is attached within envelope 12 can be removed by manually tearing envelope 12 at tear points 22, 22' as seen in Fig. 1. Catheter 11 is then inserted into the urethra after it passes through the opening formed after tearing along tear line 23, 23'. Thus, the user does not need to touch or contact catheter 11, and the insertion progresses through manual manipulation of the remaining envelope section 28 surrounding catheter 11 after end 24 is removed as seen in Fig. 2. Thus, by tearing envelope 12 along lines 22, 22' after liquid pouch 17 is ruptured and catheter 11 is saturated with fluid therefrom, end 24 is removed with empty liquid pouch 17 affixed. Liquid pouch 17 is heat welded or otherwise affixed such as with adhesives along area 26 to insure envelope end 24 remains affixed in a stationary manner to liquid pouch 17 for disposal purposes. As catheter 11 is not touched during insertion, the risk of contamination is minimized.

By tearing envelope 10 along lines 22-22' and 23-23', catheter 11 can be inserted into the urethra as aforedescribed without direct contact therewith to preserve the sterile condition of catheter 11. Conical catheter end 25 can remain within envelope 12 during use whereby section 28 of envelope 12 acts as a convenient extension of catheter 11 as needed for draining urine into a commode or other final collection vessel. After catheterization is complete, catheter 11 can be withdrawn into section 28 for disposal purposes.

In another embodiment, catheter package 29 in Fig. 3 contains catheter 11 positioned partially beneath liquid pouch 17. Tear notches 34, 34' and 35, 35' in envelope 30 allow it to be manually opened for catheter 11 insertion and end 38 (Fig. 4) to be completely removed therefrom which liquid pouch 17, now empty remains within envelope 30. Catheter package 29 provides an additional advantage in that once burstable liquid pouch 17 has been ruptured and catheter 11 inserted and removed from envelope 39, liquid pouch 17 and envelope 30 can be disposed of together, without liquid pouch 17 being separated therefrom which may be important, should the user be concerned with contact of any remaining liquid from liquid pouch 17.

The illustrations and examples provided herein are for explanatory purposes and are not intended to limit the scope of the appended claims.

Claims

η C laims

1. A catheter package comprising an envelope, said envelope defining an internal chamber, a catheter, said catheter contained within said internal chamber, a liquid pouch, said liquid pouch enclosed within said internal chamber proximate said catheter, said liquid pouch formed from a flexible film whereby moderate external pressure applied to said liquid pouch will cause said liquid pouch to rupture and allow the contents thereof to escape onto said catheter.

2. The catheter package of claim 1 wherein said envelope comprises a tear notch.

3. The catheter package of claim 1 wherein said envelope comprises a plurality of opposing tear notches.

4. The catheter package of claim 1 wherein said envelope defines a terminal tear notch for opening said chamber to remove said catheter therethrough.

5. The catheter package of claim 4 wherein said envelope further defines a proximal tear notch to allow said chamber to act as a drain conduit after insertion of said catheter.

6. The catheter package of claim 1 wherein said liquid pouch is positioned atop said catheter.

7. The catheter package of claim 1 wherein said liquid pouch is affixed at one end of said envelope, to allow said liquid pouch to be removed therefrom with said envelope end.

8. A method of using a packaged catheter having a liquid pouch and catheter within an envelope comprising the steps of: a) bursting the liquid pouch; b) saturating the catheter with the liquid contained therein; and c) tearing the envelope to remove the spent liquid pouch.

9. The method of claim 8 further comprising the step of inserting the catheter.

10. The method of claim 8 wherein bursting the liquid pouch comprises the step of maintaining the liquid contained therein within the envelope.

11. The method of claim 8 wherein tearing the envelope comprises the step of tearing the envelope along notches contained within said envelope.