WO1997017035A1

WO1997017035A1 - Disposable cover

Info

Publication number: WO1997017035A1
Application number: PCT/IL1996/000144
Authority: WO
Inventors: Arie Koren
Original assignee: Pharma-Sept Ltd.
Priority date: 1995-11-09
Filing date: 1996-11-07
Publication date: 1997-05-15
Also published as: IL115947A0; AU7331596A

Abstract

Sterile cover enables the sterilization of the C-arm of X-ray machines, while the cover is attached to the C-arm. The cover is expendable, for a one-time use. The sterile cover includes clips shaped such as to achieve reliable, fast and easy attachment to the C-arm. The cover has dimensions adapted to those of the C-arm so as to cover the C-arm when attached thereto. The clips have the suitable shape and dimensions and an elastic property so as to attach reliably to the C-arm. The cover and clips structure provide for covering three sides of the C-arm, with the fourth side being left uncovered. The fourth side includes the sliding member. The device provides for C-arm sterilization, without interfering with normal X-ray machines operation. The cover can be used with existing C-arms, and there is no need whatsoever to make changes in the C-arm itself. The cover and clips are made of polyethylene or PVC or other plastic material or cotton or woven or unwoven fabric or viscose used for medical purposes.

Description

Disposable cover

This invention concerns a sterile cover for medical instruments, and more particularly to such a cover adapted for use with the C- arm of X- ray machines. Various devices and methods have been devised to sterilize the medical equipment used in operation rooms or for other medical purposes. The equipment may be sterilized by the use of chemical or physical agents, for example using hot steam.

A more convenient sterilization means uses expendable sterile covers wrapped around the medical equipment. The expendable cover is used only once; it is removed and thrown away after use.

Until now, it was difficult to sterilize the C- arm of X- ray machines using sterile covers. A sliding member mounted on one side of the C- arm precludes the use of covers wrapped around the C- arm; such a cover would interfere with the normal operation of the X- ray machine.

A commonly approach now in use is not to sterilize the C- arm at all; this is undesirable, since some of the medical team may inadvertently touch the C- arm and later contaminate the patient.

Another method known in the art is to cover only three sides of the C- arm with a sterile cover, using adhesives to attach the cover to the equipment. Disadvantages of this method include the difficulty in removing afterwards the cover and the adhesive from the equipment.

Buckingham et al., US Patent 5,426,683 discloses a one-piece C-arm for use with X-ray diagnostic equipment included in cross-section two generally vertical sidewalls extending generally parallel to one another, an inner support wall connecting the sidewalls, and an outer support wall spaced apart from the inner support wall and connecting the sidewalls. There is no description in Buckingham of disposable covers for sterilization purposes. Szabo, US Patent 5325846, discloses a cover to drape an endoscope. It used a cylindrical drape cartridge which itself acts as a shroud and functions as a sterile barrier. The drape is specifically adapted to cover an endoscope, and is not suitable to cover the C- arm of X- ray machines.

Banys et al., US Patent 5,301 ,657 discloses a disposable sterile sleeve which is removably attachable to a video camera of an arthroscope. The sleeve comprises a flexible elongate tubular shroud and a rigid annular mounting collar. The shroud is open ended with the collar rotatably attached to one open end by a connector member providing independent rotation of the collar relative to the shroud. The sleeve is thus specifically adapted to cover a video camera, and is not suitable to cover the C- arm of X- ray machines.

Hicks, US Patent 5,198,894 also discloses a cover to drape an endoscope. It used a sleeve-like drape secured in a retracted position at the proximal end of the endoscope. The proximal end of the endoscope is secured to a CCD camera, the drape is extended to telescope over and envelope the camera such that the resulting outer surface of the drape in its extended position remains sterile.

Adair, US RE34002, discloses a sterilizable video camera cover is provided which has a connector having a guideway for receiving an unsterile video camera within it in a predetermined fixed orientation. A receptacle is provided for holding the camera in this position against a window at the distal end of the connector which serves as a bacteria barrier. An end is provided distally of the window for receiving a sterile mount and endoscope in a fixed position with respect to the camera. An accordion folded sleeve is positioned on the receptacle for being extended over the trailing cable of the video camera to maintain the sterile environment within the operating room even though the camera and trailing cable are unsterile.

Cunningham, US Patent 4,522,196 discloses a sterile covering for enabling an endoscope to be attached to or detached from a camera coupling without contamination by either the camera or the coupling. The sterile covering encloses the camera and is disposed within a cavity of a C-mount coupling which couples the endoscope to the camera. The covering includes a system for registering an optically clear portion of the covering, an optically clear film, or an element coupled to the covering with the endoscope-to-camera optical path. The covering is thus specifically adapted to cover an endoscope, and is not suitable to cover the C- arm of X- ray machines.

O'Farrell, Jr. et al., US Patent 5,506,882 discloses a one-piece C- arm for use with X-ray equipment, with grooves being formed on the vertical sidewalls of the C- arm, for receiving clips which, in turn, hold a surgical drape for preventing the contamination of the C- arm.

The drape with clips can be only attached to C- arms which are manufactured with grooves for that purpose; thus, the drape cannot be used with the multitude of existing C- arms, which are presently installed in hospitals and other facilities. Moreover, the drape is intended to only cover the inner circumference of the C-arm, which is one of the four sides of the C-arm. This Ieaves the side walls of the C- arm mainly uncovered. This is a real disadvantage, since these sides are not sterile and are exposed, such that personnel may inadvertently touch these side walls of the C-arm and become unsterile.

An additional disadvantage of this prior art device is the difficulty in attaching the drape to the C- arm. One should visualize the situation where a person which was sterilized is trying to attach a sterile drape to an unsterile C- arm. That person avoids coming in contact with the C- arm; every part of the drape which comes into contact with the C-arm becomes immediately unsterile, therefore only one side of the drape should contact the C- arm. Under the abovedetailed constraints, it is difficult to aim each clip to mount it straight into the corresponding groove. Any error in achieving that may demand to throw away the drape and try a new one.

Another disadvantage of that drape is that the distance between the ends or flanges of the clip is smaller than the width of the C- arm itself; this is necessary to allow the clip to attach to the C- arm. It is very difficult, under the circumstances, to prevent the outer side of these flanges from coming into contact with the C- arm, and thus become contaminated. It is also difficult to prevent the personnel from subsequently touching these outer sides of the flanges. It is also difficult for the personnel, after having inserted one flange in its groove, to deform the clip in order to insert the other flange, without touching either contaminated the C- arm or the part of the cover which was already contaminated by contact with the C- arm.

According to the present invention, there is provided an expendable cover for facilitating the sterilization of the C- arm of X- ray machines.

According to one aspect of the present invention, there is provided a sterile cover including clips for reliable, fast and easy attachment to the C- arm. The cover has suitable dimensions so as to cover the C- arm when attached thereto. The clips have the suitable dimensions and an elastic property so as to attach reliably to the C- arm.

According to a second aspect of the present invention, the cover and clips structure provide for covering three sides of the C- arm, with the fourth side being left uncovered. The fourth side includes the sliding member.

Thus, the device provides for C- arm sterilization, without interfering with normal X- ray machines operation.

According to a third aspect of the present invention, the cover includes attaching means which have a shape and dimensions corresponding to the cross-sectional shape and dimensions of the C- arm which is to be covered, to achieve reliable attachment thereto.

According to a fourth aspect of the present invention, the cover includes means for fast and easy attachment to the C- arm, while preventing contamination of either the cover or the personnel who is attaching it.

The ends of the clips flare out such that, when the clip is forcibly pushed against the C-arm, its ends are forced apart, to engulf the C-arm.

According to a fifth aspect of the present invention, the cover and clips are made of polyethylene or PVC or other plastic material or cotton or woven or unwoven fabric or viscose used for medical purposes. According to a sixth aspect of the present invention, reliable and low cost means for fastening the clips to the cover are provided. Medical use demands reliable operation; low cost is required of practical, expendable covers.

Further objects, advantages and other features of the present invention will become obvious to those skilled in the art upon reading the disclosure set forth hereinafter.

The invention is further described by way of example with reference to the accompanying drawings, in which:

Fig. 1 illustrates the structure and operation of the X- ray equipment with its C- arm in sterilized cover.

Fig. 2 details the C- arm wrapped in the sterile cover with clips.

Fig. 3 is a cross- sectional illustration of the clip used to clasp the cover to C- arm.

Referring to Fig. 1 , an example of an X- ray equipment with its C- arm in sterilized cover according to this invention, X- ray head 1 is attached to one end of C- arm 2. C- arm 2 has the shape of a circular arc, which is part of an imaginary circle 24.

Beam 3 has one of its ends 31 secured to fixed base 4, with the other end 32 having a sliding mount to C- arm 2. This structure provides mechanical support for X- ray head 1 , while allowing it to be moved along the perimeter of imaginary circle 24. Figs. 1 (A) and 1 (B) detail X- ray head 1 at different positions along circle 24. It is this movement of beam 3 along C- arm 2 which makes the covering of C- arm 2 difficult; there is no problem in covering X- ray head 1 and beam 3.

Fig. 1 (A) illustrates C- arm 2 with sterile cover 5 attached thereon; sterile clips 6, 601 , 602, 603, 604 and 605 are used to clasp cover 5 to C- arm 2. In a preferred embodiment, cover 5 completely covers three sides of the C- arm 2, that is all sides except the outer side which is attached to beam 3. This is important so as to prevent contamination of personnel who may inadvertently touch the sides of the C-arm. The means to accomplish this covering of three sides of the C-arm is details with reference to Fig. 2 below.

Fig. 2 details the structure of C- arm 2 wrapped in sterile cover 5 with clips 6, 601 , 602, 603, 604 and 605. Cover 5 covers three sides 24, 25, 26 of C- arm 2; the fourth side, side 23, is left uncovered, to allow the sliding movement of bar 3 thereon.

In a preferred embodiment, clips 6, 601 , 602, 603, 604 and 605 have side arms like 62 of clip 6, which are longer than the width of side 24 of C-arm 2 as shown, thus cover 5 completely covers three sides of C- arm 2 to protect the personnel from contamination.

Cover 5 and clips 6, 601 , 602, 603, 604, 605 are sterile, thus attaching them to C- arm 2 achieves a sterile C- arm.

Thus, the present invention provides for C- arm sterilization, without interfering with normal X- ray machine operation.

A plurality of clips 6, 601 , 602, 603, 604 and 605 are used to hold cover 5 clasped along its whole length to C- arm 2. A preferred embodiment uses six clips, although more or less clips may be used.

The clips are identical in shape and size, and are attached to cover 5 at about equal distances from each other along the length of cover 5. The clips may be attached to cover 5 at unequal distances, so as to adapt to handles or other irregularities in the C- arm shape, or for other purposes.

The present invention provides for fast and easy mounting of cover 5: clip 6 has an approximate U- shape, with its arms 61 , 62 pointing inwards and its ends 63, 64 flaring out. ( Arm 61 is not visible in Fig. 2, and it can be seen in Fig. 3 ; Fig. 3 shows clip 6 in its relaxed state ).

Thus, when clip 6 is forcibly pushed against C- arm 2, its ends are forced apart, together with the sides of cover 5, so that cover 5 engulfs C- arm 2 and is kept in place by the elastic deformation of clip 6. It takes just several seconds to push all clips 6, 601 , 602, 603, 604, 605 in place, to attach cover 5 to C- arm 2. The personnel who attach the cover 5 has only to hold it on its inner part, that is the part farthest away from C- arm 2; thus there is no practical danger of contamination by their touching the C- arm 2. The special shape of the clips, with the flaring out ends like ends 63, 64 of clip 6, further protects the personnel from touching the C- arm 2 while attaching cover 5 to C- arm 2.

The elastic property of clip 6 and its shape, conformal to C- arm 2, result in clip 6 clasping C- arm 2, to hold cover 5 reliably in place.

To achieve this performance, the shape of clip 6 has to conform closely to the cross-section of C- arm 2; for the various models of X-ray machines, corresponding models of the clips in this invention, having adequate dimensions, will be used. Additionally, the dimensions of cover 5 for each model will be made according to the dimensions of the corresponding C- arm 2. Thus, the cover in the present invention can be attached to existing C- arms of X-ray machines, without any change being required to be made to the C- arm itself. For best performance, for each type of C-arm there will be made covers of appropriate length and having appropriate shape of the clips, to conform to that specific C- arm.

Similarly, pulling cover 5 or clip 6 back and away from C- arm 2 results in easy and fast removal of cover 5 from C- arm 2 after use.

Fig. 3 is a cross- sectional illustration of clip 6 used to clasp sterile cover 5 to

C- arm 2. Clip 6 is detailed in its normal state, while it is not mounted on C- arm 2 and is not subject to elastic deformation. The drawing is not to scale. Clip 6 includes base 65 and two arms 61 , 62. Base 65 is curved inwards and the angle formed by curved part 651 is such that arms 61 and 62 point inwards as well. Clip 6 is shaped such that, when C- arm 2 is inserted between arms 61 and 62, arms 61 and 62 become parallel to each other and in touch with the sides of C- arm 2 (not shown), while base 65 flattens to lay on the third side of C-arm 2. Additional layer 652 set on base 65 and part of arms 61 , 62 forms a H- profile or similar cross section having increased mechanical strength as required to reliably clasp C- arm 2.

Clip 6 is symmetrical about symmetry axis 66, therefore only one arm will be detailed.

Each of the two arms 61 and 62 has a part curved outwards, like part 622 as shown. This results in clip ends 63, 64 pointing outwards and away from axis 66. Rotary joint 641 allows for the rotation of arm 68, it being shown in its open position. Arm 68 can be rotated down as indicated by arrow 67, until it lines up with arm 62 and its end 64; in this position, buttons 683 and 684 and their corresponding parts 623 and 624 join to fasten arm 68 to arm 62.

Cover 5 is attached to clip 6 as follows: While arms 68, 687 are in the open position, as detailed in Fig. 3, cover 5 is wrapped around clip 6 as shown. Arm 68 is then rotated about rotary joint 641 in the direction of arrow 67, until buttons 683, 684 fasten arm 68 to arm 62, with one side of cover 5 secured therebetween. Similarly, arm 687 is fastened to arm 61 , with the other side of cover 5 secured therebetween. Thus, cover 5 is attached to clip 6 and assumes its shape. An additional optional fastener (not shown) on base 65 fixes cover 5 to a third point on each clip, to avoid the rotational movement of each clip about its ends relative to cover 5.

This embodiment of the present invention provides a reliable and low cost means for fastening clips 6, 601 , 602 etc., to cover 5. No adhesives are required and no complicated processes are employed. This results in low cost covers. At the same time, cover 5 is reliably secured. ln a presently preferred embodiment, clips 6, 601 , 602, 603, 604, 605 have an approximate "U" shape. Other shapes are possible (not shown), which allow said clips to attach mechanically to the C-arm using the mechanical deformation and elastic property as detailed above.

In a preferred embodiment, cover 5 is made of polyethylene , since this is a plastic used as sterile cover and is also "green", that is environment- friendly; clips 6, 601 , 602, 603, 604, 605 are made of polypropylene, this material having an elastic property required to clasp the C- arm.

Other materials can be used for the cover and clips, like PVC or other plastic material or cotton or woven or unwoven fabric or viscose used for medical purposes. Said clips can also be made of metal or wood.

Other embodiments of the present invention are possible. For example, cover 5 can be produced so as to include flexible clips similar to clips 6, 601 , 602, 603, 604, 605 built in. In this case there is no need to attach the clips to cover 5. Said clips can be attached to cover 5 using adhesives or laser or ultrasonic welding or other means known in the art.

Cover 5 can be made of a thicker material, in a shape conforming to C-arm 2 as indicated in Fig. 2, such that the flexibility of cover 5 itself, while its arms are opened to force C- arm 2 therebetween, create the force which holds cover 5 in place, that is enclosing three of the four sides of C- arm 2.

Still other means can be used to hold cover 5 in place, for example magnetic particles (not shown) embedded in cover 5, or an electrostatic charge contained in cover 5.

The length of cover 5 as detailed above is adapted to the length of the C-arm it is intended to cover, thus having about the same length as the C-arm 2.

In another implementation of the present invention, a shorter cover is used, such that two or more units of said cover are required to cover the C-arm when attached thereon. The advantage of this embodiment is that a shorter cover is easier to manipulate.

A handle (not shown) can be attached to all or part of said clips, to provide for easier handling of cover 5, that is to attach it to C- arm or to remove it therefrom. The handle can be attached to base 65 of clip 6.

To sterilize the C-arm of an X- ray machine, cover 5 with clips 6, 601 , 602, 603, 604, 605 attached thereon are sterilized and stored in a sterile pouch or other enclosure (not shown) to keep them sterile. Other implementation would be to sterilize said cover and clips before use, and keep them bundled in a sterile package or wrapping until use.

Other embodiments of the present invention (not shown) use clips holding not three sides of the C-arm, but two sides only, or four sides. In the latter case, the arms of said clips extend to only a small part of the fourth side, so as not to interfere with the sliding member motion.

The cover detailed in the present invention can be used not only to sterilize the C-arm, but can be attached to other equipment as well, provided that said clips have suitable dimensions for that equipment. The cover can also be used as a nonsterile cover, to protect instruments from dust and dirt, while providing for fast and easy cover attachment and detachment.

It will be recognized that the foregoing is but one example of an apparatus and method within the scope of the present invention and that various modifications will occur to those skilled in the art upon reading the disclosure set forth hereinbefore.

Claims

1. A cover for sterilizing the C- arm of X- ray machines, comprising:

Cover means having dimensions adapted for covering three sides of said C- arm over the whole or part of its length; and means for attaching said cover means to said C- arm to cover said three sides of said C- arm, while said cover and said means leave the fourth side of said C-arm uncovered so as not to interfere with the movement of a sliding member along said fourth side of said C- arm.

2. A cover for sterilizing the C- arm as claimed in claim 1 , wherein said attaching means includes a plurality of clips attached to said cover and dispersed along said cover, wherein each of said clips includes means for attaching to said C- arm, such that said clips fasten said cover over its length to said C- arm.

3. A cover for sterilizing the C- arm as claimed in claim 2, wherein said clips are generally U- shaped and have a shape and size adapted to said C- arm to attach thereto.

4. A cover for sterilizing the C- arm as claimed in claim 2, wherein said clips are dispersed at different distance along said cover and C- arm, said distances being adapted to irregularities in the shape of said C- arm.

5. A cover for sterilizing the C- arm as claimed in claim 2, wherein said clips are dispersed at about equal distances from each other along said cover and C- arm.

6. A cover for sterilizing the C- arm as claimed in claim 2, wherein said clips have ends flaring out for easy attachment to said C- arm, such that said ends open out said clip when said clip is forcibly pressed to said C- arm, such that said clip opens and snaps on to clasp said C- arm.

7. A cover for sterilizing the C- arm as claimed in claim 1. wherein said cover is made of plastic or cotton or woven or unwoven fabric or cotton or viscose, and said attaching means are made of plastic or metal or wood.

8. A cover for sterilizing the C- arm as claimed in claim 1 , wherein said cover is made of polyethylene or PVC and said clips are made of polypropylene.

9. A cover for sterilizing the C- arm as claimed in claim 2, wherein said cover has six of said clips attached thereon.

10. A cover for sterilizing the C- arm as claimed in claim 1 , wherein said cover and said attaching means are sterilized and enclosed in a sterile cover for sterilizing said C- arm when said cover is attached to said C-arm.

11 . A cover for sterilizing the C- arm as claimed in claim 1 , wherein said attaching means includes magnetic particles embedded in said cover or an electrostatic charge contained in said cover.

12. A cover for medical instruments comprising:

Cover means having dimensions adapted for covering the whole or part of said instrument; and means for attaching said cover means to said instrument and including a plurality of clips attached to said cover and dispersed along said cover, wherein each of said clips includes means for attaching to said instrument, such that said clips fasten said cover over its length to said instrument.