US20110314619A1 - Cleaner for Medical Device - Google Patents

Abstract

A cleaner assembly (10) for cleaning a medical device such as a luer connector. The assembly includes a cup-shaped housing (12) having a cavity (18) extending from an open first end (14) to a closed second end (16), and a first scrubber (22) affixed at the bottom and along side surfaces of the cavity (18) and saturated with antimicrobial fluid. The first scrubber (22) includes compressible fingers (26) co-extending toward the open first end (14) engageable by the medical device end portion inserted into the cavity whereupon the fingers (26) scrub the exterior and interior surfaces of the end of the device and applying the antimicrobial fluid thereto by being compressed by the device end. A second scrubber (30,30′) is affixed to cavity side walls (32) adjacent the open first end and has flexible projections (34 or36) extending radially inwardly to scrub exterior surfaces of the device upon insertion.

Description

CROSS-REFERENCE TO RELATED APPLICATIONS
• This application claims priority from U.S. Provisional Patent Application Ser. No. 61/357,730 filed Jun. 23, 2010.
FIELD OF THE INVENTION
• This relates to the field of medical devices and more particularly to devices for cleaning and decontaminating a medical device such as a luer connector.
BACKGROUND OF THE INVENTION
• In catheter assemblies such as are used in hemodialysis, proximal ends of the catheters are terminated in luer connectors that are disposed outside of the patient, and the luer connectors enable easy and rapid connection to respective fluid lines of the hemodialysis apparatus in a manner permitting easy and rapid disconnect. Of course, when unconnected to the fluid lines, the ends of the luer connectors are exposed to debris and contamination and require cleaning and decontamination prior to each connection. Prior art cleaner devices for medical and dental devices, generally, are set forth in U.S. Pat. Nos. 4,439,884; 5,471,706; 6,045,539; and 6,086,275; and in U.S. Patent Publication No. US 2008/0235888.
• More recently, devices for cleaning luer connectors are known from U.S. Patent Publication No. 2006/0030827 and from U.S. Pat. No. 7,704,002. The luer cleaners set forth therein include a generally hollow body having an open first end, a closed second end, and a longitudinal axis extending therethrough between the first end and the second end. The first end is sized to receive therein the proximal end of the luer connector and includes a plurality of scrubbing elements extending generally toward the longitudinal axis sufficiently to engage the luer connector disposed therein. The second end comprises a compressible reservoir containing a cleaning fluid, wherein, when the second end is compressed, or the reservoir punctured as in the above-mentioned patent, the fluid is transmitted from the reservoir toward the first end and to the scrubbing elements. When the luer cleaner is inserted over the proximal end of the luer connector and preferably is rotated reciprocally several times about the luer's axis, the scrubbing elements engage and mildly scrub the outer surfaces of the luer connector's proximal end, including the male connector threads, to dislodge debris, and the cleaning fluid washes and thus cleans and decontaminates the luer connector end when the luer cleaner is removed from the luer connector.
• It is desired to provide a cleaning device that is simple and economical to manufacture and effective in cleaning a medical device such as a luer connector.
• It is further desired to provide an effective cleaning device needing no discrete reservoir for antimicrobial fluid.
BRIEF SUMMARY OF THE INVENTION
• Briefly, the present invention is a cleaner assembly having a housing defining a device-receiving cavity open at a first end and extending to a transverse bottom forming a closed second end. One or more scrubbing components are affixed within the cavity containing scrubbing portions that engage surfaces of the medical device inserted into the cavity thereby scrubbing them upon manipulation of the medical device, or manipulation of the cleaner assembly with respect to the medical device. The housing is preferably cup-shaped, and preferably, a cover is affixed across the open first end of the cup housing to seal the interior, which cover is peelable from the cup when desired to clean a medical device. Such a cover could be of a semi-permeable material permitting sterilization of the cleaner assembly upon completion of manufacturing.
• In a first embodiment, a scrubber component of easily compressible material is affixed within the device-receiving cavity traversing the transverse bottom, the scrubber being imbued with antimicrobial fluid and preferably comprising an open-celled foam material. Preferably, the scrubber defines an array of compressible fingers extending toward the open first end to be engaged by the inserted end of the medical device. Upon insertion, the device engages and compresses the fingers, releasing the antimicrobial fluid, and as the device is rotated and moved reciprocally, the exterior surfaces adjacent the device end, and the end surfaces and adjacent interior surfaces are scrubbed by the fingers and are sterilized by the antimicrobial fluid.
• In a second embodiment, a first scrubber component of easily compressible material is affixed within the device-receiving cavity traversing the transverse bottom, the scrubber being imbued with antimicrobial fluid and preferably comprising an open-celled foam material, similarly to the first embodiment hereinabove described. Preferably the first scrubber defines an array of compressible fingers extending toward the open first end to be engaged by adjacent surface portions of the inserted end of the medical device for scrubbing thereof. Also, upon insertion, the end portion of the device engages and compresses the fingers releasing the antimicrobial fluid, whereby the device surface portions are sterilized by the antimicrobial fluid. The assembly further includes a second scrubber component affixed within the device-receiving cavity proximally of the first scrubber component. The second scrubber component is affixed to the side walls of the cavity adjacent the open first end of the cavity and extending about halfway along the depth of the cavity. The second scrubber component defines an array of scrubber projections protruding radially inwardly from the cavity side walls to engage outer side surfaces of the end portion of the medical device inserted into the device-receiving cavity; the second scrubber may be made of an elastomeric material such as silicone rubber.
• In a third embodiment, the cleaner assembly may comprise just the second scrubber component of the previously described embodiment, alone within the device-receiving cavity.
BRIEF DESCRIPTION OF THE DRAWINGS
• The accompanying drawings, which are incorporated herein and constitute part of this specification, illustrate the presently preferred embodiments of the invention, and, together with the general description given above and the detailed description given below, serve to explain the features of the invention. In the drawings:
• FIG. 1 is an isometric view of a first embodiment of the cleaner assembly of the invention, into which a luer connector is poised to be inserted to be cleaned;
• FIG. 2 is an isometric view of the cleaner assembly ofFIG. 1;
• FIG. 3 is an exploded view of the cleaner assembly ofFIG. 2;
• FIGS. 4 and 5 are longitudinal cross-sectional views of the cleaner assembly ofFIGS. 1 to 3, before and after a luer connector is inserted thereinto to be cleaned;
• FIGS. 6 and 7 are rolled and flat views of a scrubber component ofFIGS. 1 to 5 in a rolled or curled state;
• FIG. 8 is a flat view of an alternate scrubber component similar to that ofFIGS. 6 and 7;
• FIG. 9 is an isometric view of a compressible scrubber component affixed in the cleaner assembly ofFIGS. 4 and 5;
• FIG. 10 is an isometric view of another embodiment of the cleaner assembly of the invention;
• FIG. 11 is an exploded view of the cleaner assembly ofFIG. 10; and
• FIG. 12 is an isometric view of an alternate scrubber component for the cleaner assembly of any ofFIGS. 1 to 5 or10.
DETAILED DESCRIPTION OF THE INVENTION
• In the drawings, like numerals indicate like elements throughout. Certain terminology is used herein for convenience only and is not to be taken as a limitation on the present invention. The terms “distal” and “proximal” refer, respectively, to directions closer to and away from a luer connector to be cleaned. The terminology includes the words specifically mentioned, derivatives thereof and words of similar import. The terms and expressions used herein, and the embodiments illustrated below, are not intended to be exhaustive or to limit the invention to the precise form disclosed. These terms, expressions and embodiments are chosen and described to best explain the principle of the invention and its application and practical use and to enable others skilled in the art to best utilize the invention.
• One embodiment ofcleaner assembly10 is shown inFIGS. 1 to 5 to have a cup-shaped housing12 having an open proximalfirst end14, a closed distalsecond end16, and a device-receivingcavity18 extending from the openfirst end14 to the closedsecond end16 such that the closed second end defines atransverse bottom end20 to the cavity. Afirst scrubber component22 is affixed to the cavity'sbottom end20 and also preferably to interior sidewall surface portions24, such as by use of a bonding agent. Asecond scrubber component30 is affixed to interior sidewall surface portions24 of the cup-shaped housing adjacent to the openfirst end14. Preferably, a lid40 (FIGS. 2 and 3) is affixed over the open proximal end ofcleaner assembly10 to maintain sterility and to retain the antimicrobial fluid within the assembly following completion of the manufacturing thereof; thehousing12 may have a peripheralproximal flange42 having a flatproximal edge surface44 to provide a greater surface area for adhering thelid40 to the proximal end. InFIG. 1, aluer connector50 is poised to be inserted into the cleaner assembly to be cleaned.
• Cleaner assembly10 is shown in cross-section inFIGS. 4 and 5, illustratingfirst scrubber component22 affixed at the bottom of device-receivingcavity18, andsecond scrubber component30 affixed to interiorside wall portions24 proximate the openfirst end14 of cup-shaped housing12. InFIG. 5,luer connector50 has been inserted intocavity18 to be engaged by and scrubbed by first andsecond scrubber components22,30.
• First scrubber component22, as seen inFIGS. 3 to 5 and9, defines an array offingers26 co-extending toward the openfirst end14 to engage a medical device inserted into thecavity18.Fingers26 extend from about the median transverse plane

  

  of the first scrubber component toward the open first end of thehousing12. Preferably, the first scrubber component is a one-piece or integral component of easily compressible material, such as open-celled foam material, capable of retaining saturated therein an antimicrobial fluid for sanitizing the medical device (not shown) inserted into the cavity upon compressing thefingers26 during cleaning.
• An exemplary foam material forscrubber component22 is open-celled or close-celled polyurethane foam.Fingers26 may be formed in the component by forming a gridwork ofcuts28 into a proximal end of the scrubber component extending about halfway along the length of the scrubber component, to about its medial transverse plane

  

  , thus providing separation of the resultant “fingers”26 from each other. Such cuts may be formed by die cutting. Thefingers26 may be of equal length or, as seen inFIGS. 3 to 5 and9, their lengths may vary from each other, such as more central ones offingers26 projecting more proximally than peripheral ones offingers26 of thefirst scrubber component20. Also, the longer central fingers may project beyond the distal edge ofsecond scrubber component30, if desired. Optionally, the fingers may be configured into cylindrical or conical shapes (not shown). One example of antimicrobial fluid absorbed by the scrubber component is isopropyl alcohol in a polymer suspension, such as polyvinyl alcohol sold commercially by GOJO Industries as PURELL (trademark) cleanser, although other fluids may be used such as povodine iodine, chlorhexidine gluconate, betadyne or hydrogen peroxide, or a combination thereof.
• Second scrubber component30 is depicted inFIGS. 3 to 7 in a first embodiment. It may preferably be formed of an integral or one-piecerectangular body32 that is generally flat and rather thin, as seen inFIG. 7, and which is then curled up and installed within thehousing12 down to the proximal end offirst scrubber component22 to extend circumferentially around the cavity proximate theproximal housing end14, such as by use of a bonding agent such as LOCTITE (trademark of Henkle North America) cyanoacrylate or other acrylic adhesive, or an epoxy adhesive.Second scrubber component30 defines an array offlexible projections34 that upon installation in the housing, project radially inwardly. Adjacent thebody32, the flexible projections may have any suitable configuration or shape such as a rectangular cross-section as shown, and the projections may vary in length within the same array. The end portions of theflexible projections34 will engage the exterior surfaces of the end portion of a medical device inserted into the device-receivingcavity18 for scrubbing the device end portion.
• Flexible projections34 ofsecond scrubber component30 may be blunt-ended as shown inFIGS. 3 to 7, or, as is seen inFIG. 8 in a second embodiment, theflexible projections36 ofcomponent30′ may be point-shaped; both shapes may be used in the same array, as well as any other suitable shape or configuration. The end portions of theflexible projections34,36 will engage the exterior surfaces of the end portion of a medical device inserted into the device-receivingcavity18 for scrubbing the device end portion. Antimicrobial fluid initially absorbed into thefirst scrubber component22 would be expressed therefrom upon insertion of the medical device end portion into the cavity thus compressing the foam material thereof, and the fluid would flow along the second scrubber component and its flexible projections, and the medical device itself, to the exterior surfaces thereof. Materials for thesecond scrubber component30 include silicone elastomer, polyurethane, polypropylene and others.
• Cup-shapedhousing12 may be formed of any suitable plastic materials such as polyethylene, polypropylene and the like; preferably,housing12 is of PETG, or polyethylene terephthalate glycol material.Peelable lid22 may preferably be TYVEK (trademark of E. I. DuPont de Nemours & Co.) high density polyethylene material, or similar material, adhered across the proximal end ofhousing12, such as by heat sealing. Such a lid forms a semipermeable membrane permitting infusion of sterilization gas into the cleaner assembly, such as ethylene oxide, for sterilization of the assembly after completion of its manufacturing. Preferably, the second scrubber component's proximal edge is recessed slightly into the cavity so as not to interfere with sealing of thelid40 to the housing proximal end.
• In accordance with the present invention, the cleaner assembly may utilize the cup-shaped housing, with peelable lid, and only utilize a single scrubber component at least similar tosecond scrubber component30 ofFIGS. 3 to 8, and, preferably, such scrubber may extend for most of the depth of the cavity.
• Cleaner assembly110 is shown inFIGS. 10 and 11 to have a cup-shapedhousing112 having an open proximalfirst end114, a closed distalsecond end116, and a device-receivingcavity118 extending from the openfirst end114 to the closedsecond end116 such that the closed second end defines a transversebottom end120 to the cavity. Ascrubber component22 or122 is affixed to the cavity'sbottom end120 and also preferably to interior sidewall surface portions124, such as by use of a bonding agent. Preferably, a lid140 (FIGS. 11 and 12) is affixed over the open proximal end ofcleaner assembly110 to maintain sterility and to retain the antimicrobial fluid within the assembly following completion of the manufacturing thereof; thehousing112 may have a peripheralproximal flange142 having a flatproximal edge surface144 to provide a greater surface area for adhering thelid140 to the proximal end. Preferably, the proximal end of the scrubber component is recessed slightly into the cavity so as not to interfere with sealing thelid140 onto the housing. InFIG. 10, aluer connector50 is shown poised to be inserted into the cleaner assembly to be cleaned.
• Scrubber component22 defines an array offingers26 co-extending toward the openfirst end114 to engage a medical device inserted into thecavity118.Fingers26 extend preferably from about the median transverse plane

  

  of the scrubber component to at least proximate the open first end of thehousing112. Preferably, the scrubber component, similarly toscrubber component22 ofFIGS. 3 to 5 and9, is an integral or one-piece component of easily compressible material, such as foam material, capable of retaining imbued therein an antimicrobial fluid for sanitizing the medical device inserted into the cavity upon compressing thefingers26 during cleaning.
• Fingers26 may be formed in the component by forming a gridwork ofcuts28 into a proximal end of the scrubber component extending about halfway along the length of the scrubber component, to about its medial transverse plane

  

  , thus providing separation of the resultant “fingers”26 from each other. Such cuts may be formed by die cutting. The fingers may be of equal length, as seen inFIG. 10, or their lengths may vary from each other, such as withscrubber122 ofFIG. 12, where morecentral fingers130 projecting more proximally thanperipheral fingers132. Optionally, the fingers may be shaped to be cylindrical or conical (not shown).
• It will be appreciated by those skilled in the art that changes could be made to the embodiments described above without departing from the broad inventive concept thereof. It is understood, therefore, that this invention is not limited to the particular embodiments disclosed, but it is intended to cover modifications within the spirit and scope of the present invention as defined by the appended claims.

Claims (45)

1. A cleaner device for cleaning an end portion of a medical device, comprising:

a housing having an open first end and a closed second end and a device-receiving cavity therein extending from the open first end toward the closed second end; and

a first scrubber component affixed to the cup-shaped housing at the closed second end and within the cavity, the scrubber component being of compressible material capable of containing antimicrobial fluid and including an array of compressible fingers co-extending at least toward the open first end, whereby the fingers are engaged and compressed by an end portion of the medical device upon its insertion into the cavity so that the fingers scrub the adjacent surface portions of the device end portion and that antimicrobial fluid imbued in the scrubber component sanitizes the device end portion; and

a second scrubber component affixed to the cup-shaped housing adjacent the open first end and axially along a substantial length of the interior side walls of the housing, the second scrubber defining an array of flexible projections along the length and extending radially inwardly to be engaged by exterior surfaces of an end portion of the medical device upon its insertion into the device-receiving cavity, for scrubbing the exterior device surfaces adjacent to the flexible projections when the device is manipulated within the cavity.

2. The cleaner device ofclaim 1, wherein the housing is cup-shaped.

3. The cleaner device ofclaim 1, wherein the first scrubber component is adhered to a transverse wall defined at the closed second end and the interior side surfaces.

4. The cleaner device ofclaim 1, whereby the first scrubber component is saturated with the antimicrobial fluid.

5. The cleaner device ofclaim 4, wherein the first scrubber component is formed of foam material.

6. The cleaner device ofclaim 5, whereby the first scrubber component is formed of open-celled foam material.

7. The cleaner device ofclaim 4, wherein the foam material is polyurethane material.

8. The cleaner device ofclaim 1, wherein the fingers are of a common length.

9. The cleaner device ofclaim 1, wherein the fingers adjacent the side walls of the cavity are shorter than the fingers toward the center of the cavity.

10. The cleaner device ofclaim 1, further including a peelable lid affixed to the cup-shaped housing and peelable therefrom to access the device-receiving cavity.

11. The cleaner device ofclaim 10, wherein the peelable lid is semipermeable to permit infusion therethrough of sanitizing gas upon completion of manufacture of the cleaner device.

12. The cleaner device ofclaim 11, wherein the housing is of polyethylene terephthalate glycol material and the peelable lid is of high density polyethylene material.

13. The cleaner device ofclaim 1, wherein the second scrubber component is an integral flat, thin member defining the array of flexible projections along a first surface thereof, and wherein the second surface thereof is affixed to the interior surfaces of the housing cavity.

14. The cleaner device ofclaim 13, wherein the flexible projections extend to blunt ends.

15. The cleaner device ofclaim 13, wherein the flexible projections extend to pointed ends.

16. The cleaner device ofclaim 13, wherein the second scrubber member is of elastomeric material.

17. The cleaner device ofclaim 16, wherein the material is silicone elastomer.

18. A cleaner device for cleaning an end portion of a medical device, comprising:

a housing having an open first end and a closed second end and a device-receiving cavity therein extending from the open first end toward the closed second end; and

at least a scrubber component affixed to the housing at least adjacent the open first end and axially along a substantial length of the interior side walls of the housing, the scrubber component defining an array of flexible projections along the length and extending radially inwardly to be engaged by exterior surfaces of an end portion of the medical device upon its insertion into the device-receiving cavity, for scrubbing the exterior device surfaces adjacent to the flexible projections when the device is manipulated within the cavity.

19. The cleaner assembly ofclaim 18, wherein the housing is cup-shaped.

20. The cleaner assembly ofclaim 18, wherein the scrubber component is an integral member of elastomeric material.

21. The cleaner device ofclaim 18, wherein the scrubber component is an integral flat, thin member defining the array of flexible projections along a first surface thereof, and wherein a second opposite surface thereof is affixed to the interior surfaces of the housing cavity.

22. The cleaner device ofclaim 18, wherein the flexible projections extend to blunt ends.

23. The cleaner device ofclaim 18, wherein the flexible projections extend to pointed ends.

24. The cleaner device ofclaim 18, wherein the scrubber component is of elastomeric material.

25. The cleaner device ofclaim 24, wherein the material of the scrubber component is silicone elastomer.

26. A scrubber component for a cleaner assembly for cleaning a medical device, the assembly including a housing defining a device-receiving cavity thereinto, comprising:

an integral member of elastomeric material, the member defining an array of flexible projections extending from a first surface thereof such that, when the integral member is affixed along interior side walls of the housing defining a device-receiving cavity, the flexible projections extend radially inwardly to engage adjacent exterior surfaces of a medical device inserted into the device-receiving cavity, for scrubbing the exterior surfaces when the medical device is manipulated within the cavity.

27. The scrubber component ofclaim 26, wherein the scrubber component is initially a flat, thin member defining the array of flexible projections along a first surface thereof, and wherein a second opposite surface thereof is affixed to the interior surfaces of the housing cavity.

28. The scrubber component ofclaim 26, wherein the flexible projections extend to blunt ends.

29. The scrubber component ofclaim 26, wherein the flexible projections extend to pointed ends.

30. The scrubber component ofclaim 26, wherein the scrubber component is of elastomeric material.

31. The scrubber component ofclaim 26, wherein the material is silicone elastomer.

32. A cleaner device for cleaning an end portion of a medical device, comprising:

a housing having an open first end and a closed second end and a device-receiving cavity therein extending from the open first end toward the closed second end; and

a scrubber component affixed to the housing at the closed second end and within the cavity, the scrubber component being of easily compressible material saturatable with antimicrobial fluid and including an array of compressible fingers co-extending at least toward the open first end, whereby the fingers are engaged and compressed by an end portion of the medical device upon its insertion into the cavity so that the fingers scrub the adjacent surface portions of the device end portion and that antimicrobial fluid imbued in the scrubber component sanitizes the device end portion.

33. The cleaner device ofclaim 32, wherein the housing is cup-shaped.

34. The cleaner device ofclaim 32, wherein the scrubber component is adhered to a transverse wall defined at the closed second end and the interior side surfaces.

35. The cleaner device ofclaim 32, whereby the scrubber component is saturated with the antimicrobial fluid.

36. The cleaner device ofclaim 32, whereby the scrubber component is formed of foam material.

37. The cleaner device ofclaim 36, wherein the foam material is open-celled or close-celled foam material.

38. The cleaner device ofclaim 37, wherein the foam material is polyurethane foam.

39. The cleaner device ofclaim 32, wherein the fingers are of a common length.

40. The cleaner device ofclaim 32, wherein the fingers vary in length.

41. The cleaner device ofclaim 40, wherein the fingers adjacent the side walls of the cavity are shorter than the fingers toward the center of the cavity.

42. The cleaner device ofclaim 32, further including a peelable lid affixed to the housing and peelable therefrom to access the device-receiving cavity.

43. The cleaner device ofclaim 42, wherein the housing includes a peripheral proximal flange having a flat proximal surface.

44. The cleaner device ofclaim 42, wherein the peelable lid is semipermeable to permit infusion therethrough of sanitizing gas upon completion of manufacture of the cleaner device.

45. The cleaner device ofclaim 44, wherein the housing is of polyethylene terephthalate glycol material and the peelable lid is of high density polyethylene material.

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