WO2011163124A1

WO2011163124A1 - Cleaner for medical device

Info

Publication number: WO2011163124A1
Application number: PCT/US2011/041067
Authority: WO
Inventors: Timothy M. Schweikert
Original assignee: Medical Components, Inc.
Priority date: 2010-06-23
Filing date: 2011-06-20
Publication date: 2011-12-29
Also published as: US20110314619A1

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 or 36) extending radially inwardly to scrub exterior surfaces of the device upon insertion.

Description

TITLE

Cleaner for Medical Device

[0001] 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.

[0002] 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. Patent Nos. 4,439,884; 5,471,706; 6,045,539; and 6,086,275; and in U.S. Patent

Publication No. US 2008/0235888.

[0003] More recently, devices for cleaning luer connectors are known from U.S. Patent Publication No. 2006/0030827 and from U.S. Patent 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.

[0004] 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.

[0005] It is further desired to provide an effective cleaning device needing no discrete

[0006] 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.

[0007] 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.

[0008] 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.

[0009] 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.

[0010] 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: [0011] 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;

[0012] Fig. 2 is an isometric view of the cleaner assembly of Fig. 1;

[0013] Fig. 3 is an exploded view of the cleaner assembly of Fig. 2;

[0014] Figs. 4 and 5 are longitudinal cross-sectional views of the cleaner assembly of Figs. 1 to 3, before and after a luer connector is inserted thereinto to be cleaned;

[0015] Figs. 6 and 7 are rolled and flat views of a scrubber component of Figs. 1 to 5 in a rolled or curled state;

[0016] Fig. 8 is a flat view of an alternate scrubber component similar to that of Figs. 6 and

7;

[0017] Fig. 9 is an isometric view of a compressible scrubber component affixed in the cleaner assembly of Figs. 4 and 5;

[0018] Fig. 10 is an isometric view of another embodiment of the cleaner assembly of the invention;

[0019] Fig. 11 is an exploded view of the cleaner assembly of Fig. 10; and

[0020] Fig. 12 is an isometric view of an alternate scrubber component for the cleaner assembly of any of Figs. 1 to 5 or 10.

[0021] 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.

[0022] One embodiment of cleaner assembly 10 is shown in Figures 1 to 5 to have a cup- shaped housing 12 having an open proximal first end 14, a closed distal second end 16, and a device-receiving cavity 18 extending from the open first end 14 to the closed second end 16 such that the closed second end defines a transverse bottom end 20 to the cavity. A first scrubber component 22 is affixed to the cavity's bottom end 20 and also preferably to interior side wall surface portions 24, such as by use of a bonding agent. A second scrubber component 30 is affixed to interior side wall surface portions 24 of the cup-shaped housing adjacent to the open first end 14. Preferably, a lid 40 (Figs. 2 and 3) is affixed over the open proximal end of cleaner assembly 10 to maintain sterility and to retain the antimicrobial fluid within the assembly following completion of the manufacturing thereof; the housing 12 may have a peripheral proximal flange 42 having a flat proximal edge surface 44 to provide a greater surface area for adhering the lid 40 to the proximal end. In Fig. 1, a luer connector 50 is poised to be inserted into the cleaner assembly to be cleaned.

[0023] Cleaner assembly 10 is shown in cross-section in Figures 4 and 5, illustrating first scrubber component 22 affixed at the bottom of device-receiving cavity 18, and second scrubber component 30 affixed to interior side wall portions 24 proximate the open first end 14 of cup- shaped housing 12. In Fig. 5, luer connector 50 has been inserted into cavity 18 to be engaged by and scrubbed by first and second scrubber components 22,30.

[0024] First scrubber component 22, as seen in Figures 3 to 5 and 9, defines an array of fingers 26 co-extending toward the open first end 14 to engage a medical device inserted into the cavity 18. Fingers 26 extend from about the median transverse plane P of the first scrubber component toward the open first end of the housing 12. 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 the fingers 26 during cleaning.

[0025] An exemplary foam material for scrubber component 22 is open-celled or close- celled polyurethane foam. Fingers 26 may be formed in the component by forming a gridwork of cuts 28 into a proximal end of the scrubber component extending about halfway along the length of the scrubber component, to about its medial transverse plane P , thus providing separation of the resultant "fingers" 26 from each other. Such cuts may be formed by die cutting. The fingers 26 may be of equal length or, as seen in Figs. 3 to 5 and 9, their lengths may vary from each other, such as more central ones of fingers 26 projecting more proximally than peripheral ones of fingers 26 of the first scrubber component 20. Also, the longer central fingers may project beyond the distal edge of second scrubber component 30, 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.

[0026] Second scrubber component 30 is depicted in Figures 3 to 7 in a first embodiment. It may preferably be formed of an integral or one-piece rectangular body 32 that is generally flat and rather thin, as seen in Fig. 7, and which is then curled up and installed within the housing 12 down to the proximal end of first scrubber component 22 to extend circumferentially around the cavity proximate the proximal housing end 14, 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 component 30 defines an array of flexible projections 34 that upon installation in the housing, project radially inwardly. Adjacent the body 32, 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 the flexible projections 34 will engage the exterior surfaces of the end portion of a medical device inserted into the device- receiving cavity 18 for scrubbing the device end portion.

[0027] Flexible projections 34 of second scrubber component 30 may be blunt-ended as shown in Figs. 3 to 7, or, as is seen in Fig. 8 in a second embodiment, the flexible projections 36 of component 30' 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 the flexible projections 34,36 will engage the exterior surfaces of the end portion of a medical device inserted into the device-receiving cavity 18 for scrubbing the device end portion. Antimicrobial fluid initially absorbed into the first scrubber component 22 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 the second scrubber component 30 include silicone elastomer, polyurethane, polypropylene and others.

[0028] Cup- shaped housing 12 may be formed of any suitable plastic materials such as polyethylene, polypropylene and the like; preferably, housing 12 is of PETG, or polyethylene terephthalate glycol material. Peelable lid 22 may preferably be TYVEK (trademark of E. I.

DuPont de Nemours & Co.) high density polyethylene material, or similar material, adhered across the proximal end of housing 12, 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 the lid 40 to the housing proximal end.

[0029] 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 to second scrubber component 30 of Figures 3 to 8, and, preferably, such scrubber may extend for most of the depth of the cavity.

[0030] Cleaner assembly 110 is shown in Figures 10 and 11 to have a cup-shaped housing 112 having an open proximal first end 114, a closed distal second end 116, and a device-receiving cavity 118 extending from the open first end 114 to the closed second end 116 such that the closed second end defines a transverse bottom end 120 to the cavity. A scrubber component 22 or 122 is affixed to the cavity's bottom end 120 and also preferably to interior side wall surface portions 124, such as by use of a bonding agent. Preferably, a lid 140 (Figs. 11 and 12) is affixed over the open proximal end of cleaner assembly 110 to maintain sterility and to retain the antimicrobial fluid within the assembly following completion of the manufacturing thereof; the housing 112 may have a peripheral proximal flange 142 having a flat proximal edge surface 144 to provide a greater surface area for adhering the lid 140 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 the lid 140 onto the housing. In Fig. 10, a luer connector 50 is shown poised to be inserted into the cleaner assembly to be cleaned.

[0031] Scrubber component 22 defines an array of fingers 26 co-extending toward the open first end 114 to engage a medical device inserted into the cavity 118. Fingers 26 extend preferably from about the median transverse plane P of the scrubber component to at least proximate the open first end of the housing 112. Preferably, the scrubber component, similarly to scrubber component 22 of Figs. 3 to 5 and 9, 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 the fingers 26 during cleaning.

[0032] Fingers 26 may be formed in the component by forming a gridwork of cuts 28 into a proximal end of the scrubber component extending about halfway along the length of the scrubber component, to about its medial transverse plane P , 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 in Fig. 10, or their lengths may vary from each other, such as with scrubber 122 of Fig. 12, where the more central fingers 130 projecting more proximally than peripheral fingers 132. Optionally, the fingers may be shaped to be cylindrical or conical (not shown).

[0033] 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 scope of the present invention as defined by the appended claims.

Claims

CLAIMS What is claimed is:

1. A cleaner device (10) for cleaning an end portion of a medical device (50), comprising:

a housing (12) having an open first end (14) and a closed second end (16) and a device- receiving cavity (18) therein extending from the open first end toward the closed second end; and a scrubber component (30,30') affixed to the housing at least adjacent the open first end and axially along a substantial length of the interior side walls (24) of the housing, the scrubber component defining an array of flexible projections (34,36) along the length and extending radially inwardly to be engaged by exterior surfaces of an end portion of the medical device (50) upon its insertion into the device-receiving cavity (18), for scrubbing the exterior device surfaces adjacent to the flexible projections when the medical device is manipulated within the cavity.

2. The cleaner device (10) of claim 1, wherein the scrubber component is an integral member (32).

3. The cleaner device (10) of either of claims 1 or 2, wherein the scrubber component (30,30') is an integral flat, thin member (32) defining the array of flexible projections (34,36) along a first surface thereof, and wherein a second opposite surface thereof is affixed to the interior surfaces (24) of the housing cavity (18).

4. The cleaner device (10) of any of claims 1 to 3, wherein the flexible projections (34,36) extend either to blunt ends or to pointed ends.

5. The cleaner device (10) of any of claims 1 to 4, wherein the material of the scrubber component (30,30') is silicone elastomer.

6. The cleaner device (10) of any of claims 1 to 5, further including an additional scrubber component (22,122) affixed to the housing (12) at the closed second end (16) and within the cavity (18), the additional scrubber component being of compressible material capable of containing antimicrobial fluid and including an array of compressible fingers (26,130,132) co- extending at least toward the open first end (14), whereby the fingers are engaged and compressed by an end portion of the medical device (50) 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 additional scrubber component sanitizes the device end portion.

7. The cleaner device (10) of claim 6, wherein the additional scrubber component (22,122) is formed of foam material.

8. The cleaner device (10) of either of claims 6 or 7, wherein the fingers (132) of the additional scrubber component (122) adjacent the side walls (24) of the cavity (18) are shorter than the fingers (130) located near the center of the cavity.

9. A cleaner device (110) for cleaning an end portion of a medical device (50), comprising:

a housing (112) having an open first end (114) and a closed second end (116) and a device- receiving cavity (118) therein extending from the open first end toward the closed second end; and a scrubber component (22,122) affixed to the housing at the closed second end (116) and within the cavity, the scrubber component being of easily compressible material saturatable with antimicrobial fluid and including an array of compressible fingers (26,130,132) co-extending at least toward the open first end (114), whereby the fingers are engaged and compressed by an end portion of the medical device (50) upon its insertion into the cavity (118) 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.

10. The cleaner device (110) of claim 9, wherein the material of the scrubber component (22,122) is foam material.

11. The cleaner device (110) of either of claims 9 or 10, wherein the fingers (132) adjacent the side walls of the cavity (118) are shorter than the fingers (130) located near the center of the cavity.