WO2001052763A1 - Catheter package and method - Google Patents

Catheter package and method Download PDF

Info

Publication number
WO2001052763A1
WO2001052763A1 PCT/US2000/021575 US0021575W WO0152763A1 WO 2001052763 A1 WO2001052763 A1 WO 2001052763A1 US 0021575 W US0021575 W US 0021575W WO 0152763 A1 WO0152763 A1 WO 0152763A1
Authority
WO
WIPO (PCT)
Prior art keywords
catheter
envelope
liquid
liquid pouch
package
Prior art date
Application number
PCT/US2000/021575
Other languages
French (fr)
Inventor
John H. Golden
Original Assignee
Medical Technologies Of Georgia, Inc.
Priority date (The priority date is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the date listed.)
Filing date
Publication date
Priority to US48718600A priority Critical
Priority to US09/487,186 priority
Application filed by Medical Technologies Of Georgia, Inc. filed Critical Medical Technologies Of Georgia, Inc.
Publication of WO2001052763A1 publication Critical patent/WO2001052763A1/en

Links

Classifications

    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61MDEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M25/00Catheters; Hollow probes
    • A61M25/01Introducing, guiding, advancing, emplacing or holding catheters
    • A61M25/0105Steering means as part of the catheter or advancing means; Markers for positioning
    • A61M25/0111Aseptic insertion devices
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61MDEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M25/00Catheters; Hollow probes
    • A61M25/002Packages specially adapted therefor ; catheter kit packages

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.
PCT/US2000/021575 2000-01-19 2000-08-08 Catheter package and method WO2001052763A1 (en)

Priority Applications (2)

Application Number Priority Date Filing Date Title
US48718600A true 2000-01-19 2000-01-19
US09/487,186 2000-01-19

Applications Claiming Priority (1)

Application Number Priority Date Filing Date Title
AU6760800A AU6760800A (en) 2000-01-19 2000-08-08 Catheter package and method

Publications (1)

Publication Number Publication Date
WO2001052763A1 true WO2001052763A1 (en) 2001-07-26

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Family Applications (1)

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PCT/US2000/021575 WO2001052763A1 (en) 2000-01-19 2000-08-08 Catheter package and method

Country Status (2)

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WO (1) WO2001052763A1 (en)

Cited By (19)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
WO2003092779A1 (en) * 2002-04-30 2003-11-13 Astra Tech Ab Catheter assembly
WO2004035123A1 (en) * 2002-10-18 2004-04-29 Rochester Medical Corporation Catheter wetting system and method
EP1558494A2 (en) * 2002-09-27 2005-08-03 Medtronic MiniMed, Inc. Packaging system
WO2005092418A1 (en) * 2004-03-18 2005-10-06 Manfred Sauer System for intermittent self-administration of a catheter
WO2005092419A1 (en) * 2004-03-18 2005-10-06 Manfred Sauer System for intermittently self-cathetering
US7334679B2 (en) 2004-03-15 2008-02-26 Hollister Incorporated Tear open package for hydrophilic-coated catheter
US7886907B2 (en) 2003-08-08 2011-02-15 Hollister Incorporated Vapor hydration of a hydrophilic product in a package
EP2389972A1 (en) 2010-05-25 2011-11-30 Astra Tech AB A catheter assembly comprising a receptacle accomodating a catheter and a wetting fluid pouch
GB2507474A (en) * 2012-09-18 2014-05-07 P3 Medical Ltd Medical device with hydrophilic coating
US8864730B2 (en) 2005-04-12 2014-10-21 Rochester Medical Corporation Silicone rubber male external catheter with absorbent and adhesive
US8919553B2 (en) 2006-06-08 2014-12-30 Hollister Incorporated Catheter product package and method of forming same
US8998882B2 (en) 2013-03-13 2015-04-07 C. R. Bard, Inc. Enhanced pre-wetted intermittent catheter with lubricious coating
US9033149B2 (en) 2010-03-04 2015-05-19 C. R. Bard, Inc. Catheter assembly/package utilizing a hydrating/hydrogel sleeve and a foil outer layer and method of making and using the same
WO2015105990A1 (en) * 2014-01-09 2015-07-16 Hollister Incorporated Package having integral tab with finger hole opening feature
US9707375B2 (en) 2011-03-14 2017-07-18 Rochester Medical Corporation, a subsidiary of C. R. Bard, Inc. Catheter grip and method
US9821139B2 (en) 2009-08-13 2017-11-21 C. R. Bard, Inc. Catheter having internal hydrating fluid storage and/or catheter package using the same and method of making and/or using the same
US9872969B2 (en) 2012-11-20 2018-01-23 Rochester Medical Corporation, a subsidiary of C.R. Bard, Inc. Catheter in bag without additional packaging
US10092728B2 (en) 2012-11-20 2018-10-09 Rochester Medical Corporation, a subsidiary of C.R. Bard, Inc. Sheath for securing urinary catheter
US10149961B2 (en) 2009-07-29 2018-12-11 C. R. Bard, Inc. Catheter having improved drainage and/or a retractable sleeve and method of using the same

Citations (7)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US3345988A (en) * 1965-05-27 1967-10-10 Sterilon Corp Catheter lubricating sac
US3556294A (en) * 1968-11-25 1971-01-19 Bard Inc C R Catheter package with self-contained lubricant
US3967728A (en) * 1973-03-02 1976-07-06 International Paper Company Catheter package
US4211323A (en) * 1978-12-01 1980-07-08 California Medical Developments, Inc. Disposable diagnostic swab having a stored culture medium
US4269310A (en) * 1979-05-14 1981-05-26 Uson Aurelio C Aseptic container and manipulator for a urethral catheter having an integral antiseptic solution and lubricant
US5172854A (en) * 1991-10-16 1992-12-22 Moshe Epstein Reclosable, reusable package
US5226530A (en) * 1992-03-23 1993-07-13 Golden John H Prelubricated urinary catheter and package assembly

Patent Citations (7)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US3345988A (en) * 1965-05-27 1967-10-10 Sterilon Corp Catheter lubricating sac
US3556294A (en) * 1968-11-25 1971-01-19 Bard Inc C R Catheter package with self-contained lubricant
US3967728A (en) * 1973-03-02 1976-07-06 International Paper Company Catheter package
US4211323A (en) * 1978-12-01 1980-07-08 California Medical Developments, Inc. Disposable diagnostic swab having a stored culture medium
US4269310A (en) * 1979-05-14 1981-05-26 Uson Aurelio C Aseptic container and manipulator for a urethral catheter having an integral antiseptic solution and lubricant
US5172854A (en) * 1991-10-16 1992-12-22 Moshe Epstein Reclosable, reusable package
US5226530A (en) * 1992-03-23 1993-07-13 Golden John H Prelubricated urinary catheter and package assembly

Cited By (42)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
EP1852139A1 (en) 2002-04-30 2007-11-07 Astra Tech Aktiebolag Catheter assembly
US8740863B2 (en) 2002-04-30 2014-06-03 Astra Tech Ab Catheter assembly
US9314585B2 (en) 2002-04-30 2016-04-19 Astra Tech Ab Catheter assembly
AU2003230501B2 (en) * 2002-04-30 2005-09-01 Astra Tech Ab Catheter assembly
JP2009279454A (en) * 2002-04-30 2009-12-03 Astra Tech Ab Catheter assembly
WO2003092779A1 (en) * 2002-04-30 2003-11-13 Astra Tech Ab Catheter assembly
US8986265B2 (en) 2002-04-30 2015-03-24 Astra Tech Ab Catheter assembly
EP1558494A4 (en) * 2002-09-27 2011-04-13 Medtronic Minimed Inc Packaging system
EP1558494A2 (en) * 2002-09-27 2005-08-03 Medtronic MiniMed, Inc. Packaging system
WO2004035123A1 (en) * 2002-10-18 2004-04-29 Rochester Medical Corporation Catheter wetting system and method
US9072862B2 (en) 2003-08-08 2015-07-07 Hollister, Inc. Packaged ready-to-use product
US7886907B2 (en) 2003-08-08 2011-02-15 Hollister Incorporated Vapor hydration of a hydrophilic product in a package
US8011505B2 (en) 2003-08-08 2011-09-06 Hollister Incorporated Vapor hydrated collapsible sleeve hydrophilic catheter package
US8720685B2 (en) 2003-08-08 2014-05-13 Hollister Incorporated Packaged ready-to-use product and method
USRE47513E1 (en) 2003-08-08 2019-07-16 Hollister Incorporated Packaged ready-to-use product
US7334679B2 (en) 2004-03-15 2008-02-26 Hollister Incorporated Tear open package for hydrophilic-coated catheter
WO2005092419A1 (en) * 2004-03-18 2005-10-06 Manfred Sauer System for intermittently self-cathetering
WO2005092418A1 (en) * 2004-03-18 2005-10-06 Manfred Sauer System for intermittent self-administration of a catheter
US8864730B2 (en) 2005-04-12 2014-10-21 Rochester Medical Corporation Silicone rubber male external catheter with absorbent and adhesive
US9248058B2 (en) 2005-04-12 2016-02-02 Rochester Medical Corporation, a subsidiary of C.R. Bard, Inc. Male external catheter with absorbent and adhesive
US8919553B2 (en) 2006-06-08 2014-12-30 Hollister Incorporated Catheter product package and method of forming same
US10149961B2 (en) 2009-07-29 2018-12-11 C. R. Bard, Inc. Catheter having improved drainage and/or a retractable sleeve and method of using the same
US9821139B2 (en) 2009-08-13 2017-11-21 C. R. Bard, Inc. Catheter having internal hydrating fluid storage and/or catheter package using the same and method of making and/or using the same
US10342952B2 (en) 2010-03-04 2019-07-09 C. R. Bard, Inc. Catheter assembly/package utilizing a hydrating/hydrogel sleeve and a foil outer layer and method of making and using the same
US9033149B2 (en) 2010-03-04 2015-05-19 C. R. Bard, Inc. Catheter assembly/package utilizing a hydrating/hydrogel sleeve and a foil outer layer and method of making and using the same
US9731093B2 (en) 2010-03-04 2017-08-15 C. R. Bard, Inc. Catheter assembly/package utilizing a hydrating/hydrogel sleeve and a foil outer layer and method of making and using the same
US8808275B2 (en) 2010-05-25 2014-08-19 Astra Tech Ab Catheter assembly comprising a receptacle accommodating a catheter and a wetting fluid pouch
CN102892452A (en) * 2010-05-25 2013-01-23 登士伯Ih有限公司 A catheter assembly comprising a receptacle accommodating a catheter and a wetting fluid pouch
WO2011147803A1 (en) 2010-05-25 2011-12-01 Astra Tech Ab A catheter assembly comprising a receptacle accommodating a catheter and a wetting fluid pouch
US20110295239A1 (en) * 2010-05-25 2011-12-01 Astra Tech Ab Catheter assembly comprising a receptacle accommodating a catheter and a wetting fluid pouch
EP2389972A1 (en) 2010-05-25 2011-11-30 Astra Tech AB A catheter assembly comprising a receptacle accomodating a catheter and a wetting fluid pouch
EP2730307A1 (en) * 2010-05-25 2014-05-14 Dentsply IH AB A catheter assembly comprising a receptacle accommodating a catheter and a wetting fluid pouch
AU2011257329B2 (en) * 2010-05-25 2013-11-28 Dentsply Ih Ab A catheter assembly comprising a receptacle accommodating a catheter and a wetting fluid pouch
US9707375B2 (en) 2011-03-14 2017-07-18 Rochester Medical Corporation, a subsidiary of C. R. Bard, Inc. Catheter grip and method
GB2507474A (en) * 2012-09-18 2014-05-07 P3 Medical Ltd Medical device with hydrophilic coating
US9872969B2 (en) 2012-11-20 2018-01-23 Rochester Medical Corporation, a subsidiary of C.R. Bard, Inc. Catheter in bag without additional packaging
US10092728B2 (en) 2012-11-20 2018-10-09 Rochester Medical Corporation, a subsidiary of C.R. Bard, Inc. Sheath for securing urinary catheter
US8998882B2 (en) 2013-03-13 2015-04-07 C. R. Bard, Inc. Enhanced pre-wetted intermittent catheter with lubricious coating
US9694113B2 (en) 2013-03-13 2017-07-04 C. R. Bard, Inc. Enhanced pre-wetted intermittent catheter with lubricious coating
WO2015105990A1 (en) * 2014-01-09 2015-07-16 Hollister Incorporated Package having integral tab with finger hole opening feature
US10112761B2 (en) 2014-01-09 2018-10-30 Hollister Incorporated Package having integral tab with finger hole opening feature
AU2015204761B2 (en) * 2014-01-09 2019-06-06 Hollister Incorporated Package having integral tab with finger hole opening feature

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