WO1995001765A1 - Lubricated sterile pad - Google Patents

Lubricated sterile pad Download PDF

Info

Publication number
WO1995001765A1
WO1995001765A1 PCT/US1994/007041 US9407041W WO9501765A1 WO 1995001765 A1 WO1995001765 A1 WO 1995001765A1 US 9407041 W US9407041 W US 9407041W WO 9501765 A1 WO9501765 A1 WO 9501765A1
Authority
WO
WIPO (PCT)
Prior art keywords
pad
lubricating
site
silicone oil
package
Prior art date
Application number
PCT/US1994/007041
Other languages
French (fr)
Inventor
Gordon E. Atkinson
Frank J. Beafore
Original Assignee
Vernay Laboratories, 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
Application filed by Vernay Laboratories, Inc. filed Critical Vernay Laboratories, Inc.
Publication of WO1995001765A1 publication Critical patent/WO1995001765A1/en

Links

Classifications

    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES 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
    • A61M39/00—Tubes, tube connectors, tube couplings, valves, access sites or the like, specially adapted for medical use
    • A61M39/02—Access sites
    • A61M39/04—Access sites having pierceable self-sealing members
    • A61M39/045—Access sites having pierceable self-sealing members pre-slit to be pierced by blunt instrument
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B50/00—Containers, covers, furniture or holders specially adapted for surgical or diagnostic appliances or instruments, e.g. sterile covers
    • A61B2050/005—Containers, covers, furniture or holders specially adapted for surgical or diagnostic appliances or instruments, e.g. sterile covers with a lid or cover
    • A61B2050/0065—Peelable cover
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES 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
    • A61M2205/00—General characteristics of the apparatus
    • A61M2205/02—General characteristics of the apparatus characterised by a particular materials
    • A61M2205/0222—Materials for reducing friction
    • Y—GENERAL TAGGING OF NEW TECHNOLOGICAL DEVELOPMENTS; GENERAL TAGGING OF CROSS-SECTIONAL TECHNOLOGIES SPANNING OVER SEVERAL SECTIONS OF THE IPC; TECHNICAL SUBJECTS COVERED BY FORMER USPC CROSS-REFERENCE ART COLLECTIONS [XRACs] AND DIGESTS
    • Y10—TECHNICAL SUBJECTS COVERED BY FORMER USPC
    • Y10S—TECHNICAL SUBJECTS COVERED BY FORMER USPC CROSS-REFERENCE ART COLLECTIONS [XRACs] AND DIGESTS
    • Y10S604/00—Surgery
    • Y10S604/905—Aseptic connectors or couplings, e.g. frangible, piercable

Definitions

  • the present invention relates to lubrication of medical coupling sites and, more particularly, to a method and apparatus for sterilizing and lubricating a medical coupling site prior to insertion of a male luer into the site.
  • Medical coupling sites are commonly used to provide a quick and easy to access opening for dispensing fluids into an intravenous line.
  • Medical coupling sites typically include an outer housing formed of plastic or other rigid material and a septum or valve element formed of rubber or some other elastomeric material supported within the housing.
  • U.S. Patent Application Serial No. 07/893,813, filed June 4, 1992, and assigned to the assignee of the present invention discloses a medical coupling site including a tubular valve element having a diaphragm with a slit formed therein for receiving a male luer.
  • the tubular valve element is supported by a rigid retainer or housing defining the outer wall of the coupling site.
  • the procedure followed by medical personnel during insertion of a male luer through the diaphragm includes first wiping the coupling site with a wipe containing a sterilizing agent, such as isopropyl alcohol, prior to insertion of the male luer. Subsequently, the blunt end of the male luer is engaged against the outer surface of the diaphragm forcing the diaphragm to stretch and the slit to open a sufficient extent to permit passage of the male luer. Repeated wipings of the diaphragm with the sterilizing agent results in any lubricating substances present in the elastomeric valve being removed. Consequently, the frictional force between the end of the male luer and the diaphragm surface progressively increases as more and more of the lubricating substances are removed during repeated wipes of the diaphragm with the sterilizing agent.
  • a sterilizing agent such as isopropyl alcohol
  • the insertion force required for inserting the male luer into the medical coupling site increases as the lubricating substances on the diaphragm surface are depleted.
  • the diaphragm will tend to stick to the male luer during the insertion process such that the luer tip will tend to push the end of the valve inwardly into the coupling site and away from the housing rather than sliding across the diaphragm toward the slit to thereby stretch the diaphragm and open the slit for reception of the male luer tip.
  • the present invention provides a method for lubricating a coupling site including the steps of providing a lubricating pad containing a liquid composition comprising a sterilizing agent and a lubricating agent, and wiping the site with the pad whereby the site is simultaneously sterilized and lubricated.
  • the pad preferably is provided in a sealed packet to form a package containing an individual pad such that the package may be opened and the pad removed just prior to use in wiping the site.
  • the sterilizing agent evaporates and the lubricating agent is left behind as a coating on the site for facilitating movement of the end of a male luer across the diaphragm as the male luer is inserted through the site.
  • a further object of the present invention to provide such a lubricating pad wherein the pad includes a sterilizing agent and a lubricating agent whereby a lubricating coating is left on a surface of the medical coupling site for engaging a male luer to thereby facilitate insertion of the luer into the site.
  • Fig. 2 illustrates a medical coupling site in partial cut-away section which has been wiped with a lubricating pad of the present invention prior to insertion of a male luer.
  • the present invention relates to providing a method for lubricating a medical coupling site and to an article or apparatus for carrying out the method.
  • the present invention is directed toward a lubricated pad and a method for using the pad to wipe a resilient valve element of a medical coupling site whereby the valve element is sufficiently lubricated to facilitate insertion of a male luer into the site.
  • the article for carrying out the invention includes a lubricating pad 10 and a foil packet 12 for containing the pad 10.
  • the pad 10 is preferably a fiber pad and is adapted to receive a liquid composition comprising a sterilizing agent and a lubricating agent.
  • the pad 10 preferably contains a liquid composition which comprises silicone oil and an alcohol solution wherein the alcohol solution includes approximately 70% isopropyl alcohol and 30% distilled water by volume.
  • the silicone oil and isopropyl alcohol solution are combined in a ratio which is within the range of from 1:2 to 1:20, silicone oil to alcohol solution, by volume.
  • Each individual lubricating pad 10 is sterilized and placed in a respective packet 12 which is then sealed to form a package adapted to be stored for future use.
  • the present invention is particularly adapted to be used with a medical coupling site 14 having a rigid outer housing 16 forming a supporting sleeve member for a resilient valve element 10.
  • a medical coupling site is disclosed in D.S. Patent Application Serial No. 07/093,013, filed June 6, 1992 and assigned to the assignee of the present invention, which application is incorporated herein by reference.
  • the valve element 10 disclosed in the above-noted application includes a diaphragm 20 extending diametrically across a tubular body portion 22. It should be apparent that as a male luer 24, such as the luer tip of a syringe or any other blunt cannula, is inserted through a slit 26 formed in the diaphragm, it is necessary for the sides of the luer 24 to slide past the outer surface of the diaphragm 20.
  • the lubricated pad 10 is wiped across the outer surface of the diaphragm 20 leaving a coating 28 of alcohol and silicone oil on the diaphragm 20.
  • the alcohol evaporates leaving the silicone oil as a lubricant for lubricating the surfaces contacted by the blunt end of the male luer 24.
  • the end of the luer 24 will tend to slide along the coating 28 on the diaphragm surface and merely stretch the diaphragm open at the location of the slit 26 rather than developing forces which would tend to draw the diaphragm 20 inwardly through the coupling site 14.
  • the present invention provides a method and apparatus for lubricating a medical site whereby the procedure for lubricating the site does not require medical personnel to perform any additional steps beyond the established procedure for sterilizing a medical coupling site prior to insertion of a male luer. Further, the present invention is carried out by the provision of a unique pad containing both a sterilizing agent and a lubricating agent whereby a sterilizing and lubricating step may be performed simultaneously on the coupling site.
  • isopropyl alcohol and silicone oil are disclosed as the sterilizing and lubricating agents, respectively, other medical grade sterilizing and lubricating agents may also be used within the scope of the present invention.

Abstract

A method and apparatus for simultaneously sterilizing and lubricating a medical coupling site prior to insertion of a male luer (24) into the site. A fiber pad (10) containing a liquid composition including a sterilizing agent and a lubricating agent. The sterilizing and lubricating agents are preferably isopropyl alcohol and silicone oil, respectively, such that application of the lubricating agent to the medical coupling site results in the alcohol evaporating to leave behind a coating of silicone oil (28). The silicone oil lubricates an area on the coupling site contacted by the end of a male luer (24).

Description

UBRICATED STERILE PAD Background of the Invention The present invention relates to lubrication of medical coupling sites and, more particularly, to a method and apparatus for sterilizing and lubricating a medical coupling site prior to insertion of a male luer into the site.
Medical coupling sites are commonly used to provide a quick and easy to access opening for dispensing fluids into an intravenous line. Medical coupling sites typically include an outer housing formed of plastic or other rigid material and a septum or valve element formed of rubber or some other elastomeric material supported within the housing. For example, U.S. Patent Application Serial No. 07/893,813, filed June 4, 1992, and assigned to the assignee of the present invention, discloses a medical coupling site including a tubular valve element having a diaphragm with a slit formed therein for receiving a male luer. In addition, the tubular valve element is supported by a rigid retainer or housing defining the outer wall of the coupling site.
The procedure followed by medical personnel during insertion of a male luer through the diaphragm includes first wiping the coupling site with a wipe containing a sterilizing agent, such as isopropyl alcohol, prior to insertion of the male luer. Subsequently, the blunt end of the male luer is engaged against the outer surface of the diaphragm forcing the diaphragm to stretch and the slit to open a sufficient extent to permit passage of the male luer. Repeated wipings of the diaphragm with the sterilizing agent results in any lubricating substances present in the elastomeric valve being removed. Consequently, the frictional force between the end of the male luer and the diaphragm surface progressively increases as more and more of the lubricating substances are removed during repeated wipes of the diaphragm with the sterilizing agent.
Accordingly, the insertion force required for inserting the male luer into the medical coupling site increases as the lubricating substances on the diaphragm surface are depleted. Further, as a result of the increased friction between the male luer and the diaphragm, the diaphragm will tend to stick to the male luer during the insertion process such that the luer tip will tend to push the end of the valve inwardly into the coupling site and away from the housing rather than sliding across the diaphragm toward the slit to thereby stretch the diaphragm and open the slit for reception of the male luer tip. Thus, it is apparent that there is a need for a method by which the elastomeric portion of a medical coupling site may be maintained in a lubricated state whereby insertion of a male luer through the medical coupling site is facilitated. In addition, there is a need for providing such a method without introducing any additional steps to the current procedure for preparing the coupling site to receive a male luer.
Summary of the Invention In order to facilitate insertion of a male luer into a medical coupling site, the present invention provides a method for lubricating a coupling site including the steps of providing a lubricating pad containing a liquid composition comprising a sterilizing agent and a lubricating agent, and wiping the site with the pad whereby the site is simultaneously sterilized and lubricated.
The pad preferably is provided in a sealed packet to form a package containing an individual pad such that the package may be opened and the pad removed just prior to use in wiping the site. After the site is wiped with the lubricating pad, the sterilizing agent evaporates and the lubricating agent is left behind as a coating on the site for facilitating movement of the end of a male luer across the diaphragm as the male luer is inserted through the site.
It is therefore a primary object of the present invention to provide a lubricating pad and a method for using the pad wherein the pad may be used in a procedure for preparing a medical coupling site to receive a male luer.
It is a further object of the present invention to provide such a lubricating pad wherein the pad includes a sterilizing agent and a lubricating agent whereby a lubricating coating is left on a surface of the medical coupling site for engaging a male luer to thereby facilitate insertion of the luer into the site. Other objects and advantages of the invention will be apparent from the following description, the accompanying drawings, and the appended claims. Brief Description of the Drawings Fig. 1 illustrates a lubricating pad package of the present invention in its use for wiping a medical coupling site; and
Fig. 2 illustrates a medical coupling site in partial cut-away section which has been wiped with a lubricating pad of the present invention prior to insertion of a male luer.
Detailed Description of the Preferred Embodiment The present invention relates to providing a method for lubricating a medical coupling site and to an article or apparatus for carrying out the method. In particular, the present invention is directed toward a lubricated pad and a method for using the pad to wipe a resilient valve element of a medical coupling site whereby the valve element is sufficiently lubricated to facilitate insertion of a male luer into the site. Referring to Fig. 1, the article for carrying out the invention includes a lubricating pad 10 and a foil packet 12 for containing the pad 10. The pad 10 is preferably a fiber pad and is adapted to receive a liquid composition comprising a sterilizing agent and a lubricating agent. Specifically, the pad 10 preferably contains a liquid composition which comprises silicone oil and an alcohol solution wherein the alcohol solution includes approximately 70% isopropyl alcohol and 30% distilled water by volume. The silicone oil and isopropyl alcohol solution are combined in a ratio which is within the range of from 1:2 to 1:20, silicone oil to alcohol solution, by volume. Each individual lubricating pad 10 is sterilized and placed in a respective packet 12 which is then sealed to form a package adapted to be stored for future use.
The present invention is particularly adapted to be used with a medical coupling site 14 having a rigid outer housing 16 forming a supporting sleeve member for a resilient valve element 10. Such a medical coupling site is disclosed in D.S. Patent Application Serial No. 07/093,013, filed June 6, 1992 and assigned to the assignee of the present invention, which application is incorporated herein by reference.
As may be further seen in Fig. 2, the valve element 10 disclosed in the above-noted application includes a diaphragm 20 extending diametrically across a tubular body portion 22. It should be apparent that as a male luer 24, such as the luer tip of a syringe or any other blunt cannula, is inserted through a slit 26 formed in the diaphragm, it is necessary for the sides of the luer 24 to slide past the outer surface of the diaphragm 20. Further, it should be apparent that should excessive friction develop between the outer surface of the diaphragm 20 and the outer surface of the luer 24, the luer 24 will tend to pull the diaphragm with it as the luer 24 proceeds through the tubular body 22, which could result in destruction of the coupling site 14. In addition, excessive friction also results in the production of unacceptable insertion forces being required to push the luer 24 past the diaphragm 20. In the use of the present invention, the lubricated pad 10 is wiped across the outer surface of the diaphragm 20 leaving a coating 28 of alcohol and silicone oil on the diaphragm 20. Subsequently, the alcohol evaporates leaving the silicone oil as a lubricant for lubricating the surfaces contacted by the blunt end of the male luer 24. Thus, as the end of the luer 24 comes into engagement with the diaphragm 20, the end of the luer 24 will tend to slide along the coating 28 on the diaphragm surface and merely stretch the diaphragm open at the location of the slit 26 rather than developing forces which would tend to draw the diaphragm 20 inwardly through the coupling site 14.
Thus, it should be apparent that the present invention provides a method and apparatus for lubricating a medical site whereby the procedure for lubricating the site does not require medical personnel to perform any additional steps beyond the established procedure for sterilizing a medical coupling site prior to insertion of a male luer. Further, the present invention is carried out by the provision of a unique pad containing both a sterilizing agent and a lubricating agent whereby a sterilizing and lubricating step may be performed simultaneously on the coupling site.
It should also be noted that although isopropyl alcohol and silicone oil are disclosed as the sterilizing and lubricating agents, respectively, other medical grade sterilizing and lubricating agents may also be used within the scope of the present invention.
While the method and form of apparatus herein described constitutes a preferred embodiment of this invention, it is to be understood that the invention is not limited to this precise method or form of apparatus, and that changes may be made therein without departing from the scope of the invention, which is defined in the appended claims.
What is claimed is:

Claims

1. A method of lubricating a medical coupling site including the steps of: providing a pad including a liquid composition comprising a sterilizing agent and a lubricating agent, and wiping said site with said pad whereby said site is simultaneously sterilized and lubricated.
2. The method as in claim 1 wherein said sterilizing agent comprises an isopropyl alcohol solution.
3. The method as in claim 2 wheχ-ein said lubricating agent comprises medical grade silicone oil.
4. The method as in claim 3 wherein said isopropyl alcohol solution comprises approximately 70% isopropyl alcohol and 30% distilled water by volume.
5. The method as in claim 4 wherein the ratio of said silicone oil to said isopropyl alcohol solution is in the range from 1:2 to 1:20 by volume.
6. The method as in claim 3 including the step of said alcohol evaporating to leave said silicone oil as a lubricating coating on said site.
7. The method as in claim 1 further including the step of contacting the area wiped by said pad with a male luer during insertion of said luer through said site.
0. The method as in claim 1 wherein said step of providing said pad further includes the step of opening a sealed packet containing an individual pad and removing said pad from said package. -0-
9. In combination with a medical coupling site having a resilient valve element including a diaphragm for receiving a male luer, a lubricating pad comprising: a pad, a liquid composition on said pad, said liquid composition including a sterilizing agent and a lubricating agent, and said lubricating pad being operable for wiping and coating said diaphragm with said composition wherein said sterilizing agent evaporates from said diaphragm leaving said lubricating agent coating said diaphragm to facilitate insertion of said male luer.
10. The combination as in claim 9 wherein said liquid composition comprises an alcohol solution and silicone oil.
11. The combination as in claim 10 wherein said alcohol solution comprises approximately 70% isopropyl alcohol and 30% distilled water by volume.
12. The combination as in claim 11 wherein the ratio of said silicone oil to said alcohol solution is in the range from 1:2 to 1:20 by volume.
13. The combination as in claim 9 wherein said diaphragm includes an outer surface and a slit formed in said outer surface for receiving said male luer wherein coating of said outer surface with said liquid composition facilitates movement of said male luer across said outer surface and through said slit.
14. The combination as in claim 9 wherein said pad is a fiber pad.
15. The combination as in claim 9 including a sealed foil packet for containing said lubricating pad in package form until said lubricating pad is used to wipe said site.
16. A lubricating pad package comprising: a pad, a liquid composition on said pad including a sterilizing agent and a lubricating agent, and a sealed packet containing said pad with said liquid composition.
17. The package as in claim 16 wherein said liquid composition comprises an alcohol solution and silicone oil.
10. The package as in claim 17 wherein said alcohol solution comprises approximately 70% isopropyl alcohol and 30% distilled water by volume.
19. The package as in claim 10 wherein the ratio of said silicone oil to said alcohol solution is in the range from 1:2 to 1:20 by volume.
20. The package as in claim 16 wherein said pad is a fiber pad.
21. The package as in claim 14 wherein said packet is formed of a foil material.
PCT/US1994/007041 1993-07-06 1994-06-21 Lubricated sterile pad WO1995001765A1 (en)

Applications Claiming Priority (2)

Application Number Priority Date Filing Date Title
US08/085,740 1993-07-06
US08/085,740 US5409471A (en) 1993-07-06 1993-07-06 Method of lubricating a medical coupling site

Publications (1)

Publication Number Publication Date
WO1995001765A1 true WO1995001765A1 (en) 1995-01-19

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Family Applications (1)

Application Number Title Priority Date Filing Date
PCT/US1994/007041 WO1995001765A1 (en) 1993-07-06 1994-06-21 Lubricated sterile pad

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WO (1) WO1995001765A1 (en)

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