Abstract:
A protective sheath assembly for a vaginal speculum assembly includes a disposable vaginal speculum and a reusable illumination assembly that is releasably attached to the speculum. The sheath assembly is attachable to the handle of said speculum to cover the illumination assembly while the speculum is in use and permits the illumination assembly to be easily released from the assembly following use.

Description:
FIELD OF THE INVENTION 
     The invention relates to the field of medical diagnostic instruments and more particularly to a protective sheath for an illumination assembly of a disposable vaginal speculum. 
     BACKGROUND OF THE INVENTION 
     A number of disposable plastic vaginal specula have been developed, such as described, for example, in U.S. Pat. Nos. 3,716,047 and 4,766,887, among others. These disposable vaginal specula are highly useful for high-volume clinical users. The former disposable speculum, for example, is made from a transparent plastic material, such as polystyrene, including a fixed blade portion, a movable blade portion and a slide portion permitting the blades to adjustably assume at least one of a plurality of open positions for conducting a cervical examination. 
     Illumination systems, such as the Welch Allyn 78010 and 78810 illuminator utilizing the 78000 and 78800 illuminator have been incorporated into the above disposable specula to enhance the examination. A miniature halogen or other incandescent light source is retained in an assemblage that is releasably insertable into a slot provided in a hollow leg of the fixed blade member of the speculum. A curved light conducting bar relays light from the lamp of the illumination assembly along a longitudinal axis of the fixed blade member of the speculum to a medical target area. 
     One ever present problem that has been faced since the introduction of illumination assemblies as described above is that of contamination due to exigencies of the examination process itself and the normal tendency for body fluids, etc., to make their way to the illumination assembly. While the above described specula are disposable, the illumination assemblies are intended for reuse and therefore excess contamination is a problem that reduces efficiency for the physician and/or gynecologist, given that the illumination assembly therefore requires cleaning prior to each patient use. 
     SUMMARY OF THE INVENTION 
     It is therefore a primary object of the present invention to overcome the above-noted deficiencies of the prior art. 
     It is another primary object of the present invention to better protect the illumination assembly of a disposable vaginal speculum system during examination. 
     It is yet another object of the present invention to provide a relatively inexpensive covering for an illuminator assembly used with a disposable vaginal speculum that reduces excess contamination and provides for easier cleaning of the illuminator. 
     Therefore and according to a preferred aspect of the present invention, there is provided a vaginal speculum assembly comprising: 
     a disposable speculum having a handle; 
     an illumination assembly including a light source retained within a housing that is releasably attached to said speculum, said illumination assembly further including a cord extending from said housing; 
     a protective sheath; 
     a support member attachable to the handle of said speculum onto which said protective sheath is mounted in a stored condition; 
     wherein said sheath is deployable, releasing said sheath from its stored condition so as to cover said illumination assembly including a portion of said extending portion during an examination process. 
     Preferably, the support member includes retaining means for retaining the sheath in the stored condition until the user has mounted the illumination assembly to the disposable speculum prior to the examination process. 
     According to one embodiment, the retaining means includes an elastic member which compresses and retains the stored sheath, the elastic member being held by supporting features appropriately located on the support member. 
     The support member retains the protective sheath as a compressed cylinder overlaying a spool-like portion of the member in the stored condition. The support member is hollow and includes openings through which a portion of the illumination assembly passes. This arrangement permits the sheath, when deployed, to cover the illumination assembly as a sleeve, and further permits the release of said illumination assembly in order to discard the disposable speculum and the attached sheath assembly when the examination process is completed. 
     In addition, the sheath preferably includes a tail portion that assists in the deployment of the sheath from its stored position and wherein the sheath can be shaped to conform to aspects of the illumination assembly. For example, the sheath can be properly sized to cover the extending cord and lamp enclosure as well as an inline switch assembly. 
     According to another preferred aspect of the invention, there is disclosed a method for protecting an illumination assembly of a disposable vaginal speculum from contamination during use thereof, said method comprising the steps of:
     attaching a protective sheath assembly to said disposable speculum prior to use thereof, said sheath assembly including a support member that is mounted to said speculum and includes a protective sheath disposed on said support member in a stored condition;   attaching the illumination assembly to said disposable speculum;   deploying said protective sheath from said stored condition prior to use of said speculum so as to cover said illumination assembly.   

     Preferably, the method further includes the step of placing the speculum and attached illumination assembly over a refuse container and while still holding the extending cord of the illumination assembly, easily discarding the remainder of the assembly. 
     An advantage of the herein described invention is that the illumination assembly is better protected during the examination process, thereby improving the efficiency of patient flow in the office without having to create additional inventory. 
     It is another advantage in that the sheath preferably includes an extending tail portion that assists in the deployment of the sheath from its stored condition, the sheath being shaped to easily cover the illumination assembly. 
     Removal of the reusable illumination assembly is also done advantageously in which removal of the disposable portions (speculum, sheath assembly) of the system can be easily accomplished following use of the speculum by holding the assembly over a refuse container and maintaining hold of the extending electrical cord of the illumination assembly and pushing the sheath downwardly such that contamination does not cover the illumination assembly while making the disposable portions easily discardable. 
     These and other objects, features and advantages will become readily apparent from the following Detailed Description which should be read in conjunction with the accompanying drawings. 
    
    
     
       BRIEF DESCRIPTION OF THE DRAWINGS 
         FIG. 1  is a front perspective view of a disposable vaginal speculum assembly including a protective sheath made in accordance with a preferred embodiment of the present invention; 
         FIG. 2  is a side elevational view of the vaginal speculum depicting the interconnection of the protective sheath of  FIG. 1 ; 
         FIG. 2A  is a side elevational view, in section of a fixed blade member of the vaginal speculum of  FIG. 1  and an attached sheath supporting member; 
         FIG. 3  is a side view of the sheath supporting member of  FIGS. 1–2A ; 
         FIG. 4  is the side view of the sheath supporting member of  FIG. 3  with a sheath attached thereto; and 
         FIGS. 5–9  are sequential in-use depictions of the protective sheath relative to the disposable vaginal speculum assembly. 
     
    
    
     DETAILED DESCRIPTION 
     The following description relates to the incorporation of a protective sheath for use with a specific disposable vaginal speculum assembly. It will be readily apparent to one of sufficient skill in the field, however, that the inventive concepts described herein are applicable to various speculums of differing designs and should not be regarded as being limited to that described herein. 
     Referring to  FIG. 1 , there is shown a disposable vaginal speculum system  10  in accordance with the present invention. The herein described speculum system  10  includes a disposable vaginal speculum  20 , an illumination assembly  24 , and a protective sheath assembly  100 . 
     More particularly and as shown in  FIGS. 1 ,  2  and  2 A, the disposable vaginal speculum  20  includes three main interconnected components; namely, a fixed blade member  38 , a movable blade member  42  and a slide member  46 . Each of the fixed blade member  38  and the movable blade member  42  are preferably made from a clear, inflexible plastic material, such as acrylic or polystyrene, in which the fixed blade member  38  includes a trough shaped blade and a hollow leg  50  that forms a handle for the user of the speculum  20 . The slide member  46  is preferably made from a resilient plastic material, such as polypropylene, includes a forked upper end  54  that receives the movable blade member  42  which is pivotally attached thereto, including a lever portion  58  that is adjustably attached via a ratchet mechanism  62  provided on the top of the slide member  46 . In addition, the slide member  46  includes a lower tongue  66  having ratchet teeth that engage with corresponding teeth provided on the rear side of the hollow leg  50  of the fixed blade member  38  of the disposable vaginal speculum  20  to provide further adjustment therebetween. 
     The hollow leg  50  of the fixed blade member  38  of the disposable vaginal speculum  20  includes a pair of parallel slots  70 ,  72 . Slot  70  is sized for receiving a portion of the illuminator assembly  24  as well as aligning the inserted illuminator assembly portion relative to an interior curved light bar  74 , shown in  FIG. 2A , that receives the light from a miniature incandescent lamp (not shown) contained in the inserted portion of the illuminator assembly  24  and directs it along a longitudinal axis of the fixed blade member  38 . Additional details concerning the components and overall operation of the herein described disposable vaginal speculum  20  can be found in U.S. Pat. No. 3,716,047, the entire contents of which are herein incorporated by reference. 
     Still referring in general to  FIG. 1 , the illumination assembly  24  includes a miniature light source, such as a miniature incandescent halogen lamp (not shown), that is disposed within a lamp housing  82  that is threaded into the distal end of an enclosure  86 . The enclosure  86  is that portion of the illumination assembly  24  that is placed into the slot  70  of the disposable vaginal speculum  20 . The enclosure  86  includes a gripping portion/strain relief  96  at a proximal end thereof to permit a user to insert or remove the enclosure of the illumination assembly  24  from the interior of the hollow end  50  of the disposable vaginal speculum  20 . A cord  87  extends from the gripping portion/strain relief  96  of the enclosure  86 , the cord containing a number of electrical conductors (not shown) connected to electrical contacts provided in the enclosure. 
     An in-line illumination switch assembly  85  is attached to a proximal end of the cord  87 , the in-line switch assembly including a cover housing  89  having an integral switch  91  to permit selective energization of the lamp. The cover housing  89  is tapered, preferably, and includes strain reliefs on opposite sides thereof, interconnecting the enclosure  86  and a power supply, such as a transformer  98 , in which a second cord  93  containing electrical conductors extends from the in-line switch assembly to a plug  90  that is fittable with a mating plug  94  that is tethered by a third cord  95  to the transformer  98  in order to selectively supply electrical power to the enclosed halogen lamp. 
     The lamp housing  82  includes an electrical contact (not shown) at its proximal end that engages corresponding electrical contacts inside the enclosure  86 , the housing including an internal O-ring (not shown) that is initially fused with the lamp envelope to form a substantial fluid-tight seal to prevent contaminants from entering the lamp housing  82  and enclosure  86  as described in copending and concurrently filed USSN (to be assigned) (Attorney Docket No. 281 — 392). The foregoing seal provides an advantage in that the enclosure  86  can now undergo sterilization procedures. 
     Referring to  FIGS. 1 ,  2 A,  3  and  4 , the protective sheath assembly  100  includes a sheath supporting member  104  defined by a short hollow cylindrical tubular housing  102  having a distal end  108  and a proximal opening  112 . The distal or connecting end  108  of the sheath supporting member  104  includes an outwardly extending pawl  116  adjacent a rectangular shaped insertion portion  120  having a distal opening  122 , the insertion portion being sized for engaging the slot  70  formed in the proximal end of the hollow leg  50  of the speculum  20 . The rectangular opening  122  is also sized to receive the molded body of the enclosure  86  of the illumination assembly  24 , permitting the enclosure to pass therethrough into the slot  70  of the disposable vaginal speculum  20 . The extending pawl  116  includes an engagement tooth  128  at its distalmost end and a thickened base portion  129  for positively engaging with the interior of the rear wall of the hollow leg  50  of the speculum  20 , the tooth engagement being shown in  FIG. 2A . 
     The distal end  108  of the sheath supporting member  104  further includes an annular receiving portion  134  having a diameter that is larger than that of the tubular housing portion  102 , the receiving portion including a concave supporting surface  138 . 
     The exterior or distal facing side of the annular receiving portion  134  includes a plurality of support tabs  148  used as a fastening and release means for a stored protective sheath  144  in conjunction with a plurality of spaced corresponding notches  156  provided at the proximal end of the tubular support portion  102  of the sheath supporting member  104 . As detailed below, an elastic band  152  or other restraining means is looped over the support tabs  148  and notches  156  to provide support when placed along protective sheath  144 , holding compressing and retaining the sheath in place, 
     Referring to  FIGS. 1 ,  2 ,  4  and  5 , the protective sheath  144  is a highly flexible, thin plastic sleeve-like member having a cylindrical configuration that when deployed is sized so as to cover the illumination assembly  24 , including the cords  87 ,  93  and the in-line switch assembly  85 . Preferably, the protective sheath  144  is made from polyethylene, though other suitable materials can be used, transparent or otherwise. It is not required, however, that the protective sheath  144  necessarily be constructed from a biocompatible material. In terms of preassembly, one end of the sheath  144  is fixedly attached by adhesive tape or other means to the sheath supporting member  104  and more particularly at the proximal side of the annular supporting portion  134 . In terms of compressing into the stored condition on the sheath supporting member  104 , the protective sheath  144  is initially extended and then compressed to be formed into its stored condition such that release of the elastic band  152  from the retaining means of the sheath supporting member  104  will permit the sheath to drop over the illumination assembly  24 , including the in-line switch assembly  85 , as described in greater detail below. Finally, the opposite end of the protective sheath  144  forms an protruding tail  174  extending from remainder of the compressed sheath, the tail providing a guide for the user during deployment and further including a tapered portion to assist in guiding the sheath over the in-line switch assembly. 
     Referring now to  FIGS. 5–9 , the operation of the herein described invention is summarized in use. 
     First and referring to  FIGS. 2A and 5 , the sheath supporting member  104  is attached to the proximal end of the fixed blade member  38  of the disposable vaginal speculum  20  with the protective sheath  144  already compressed in the stored condition as described above. The sheath supporting member can be provided integrally with the speculum as part of an assembly or can be separably purchased and installed by the user. The sheath supporting member  104  is attached to the disposable vaginal speculum  20  by properly aligning the extending pawl  116  at the distal end  108 ,  FIG. 4 , thereof with slot  72  of the hollow leg  50  of the speculum  20  and the insertion portion  120 ,  FIG. 2A , with slot  70  and then pushing the supporting member into place according to arrow  160 , until the engagement tooth  128  positively engages with the interior of the rear wall of the hollow leg  50 . 
     Referring briefly to  FIG. 4 , an O-ring  175  is also preferably installed onto the exterior of the insertion portion  120 . This O-ring  175  functions to take up slack for mold cavity variability in the manufacture of the sheath supporting member  104  and further provides additional protection from fluid ingress. 
     Next and referring to  FIG. 6 , the enclosure  86  of the illumination assembly  24  is then inserted as held by enclosure  86  through the proximal opening  112  and the rectangular opening  122  defined in the distal insertion portion  120 ,  FIG. 2A , of the assembled sheath supporting member  104  and into the slot  70 ,  FIG. 2A , of the hollow leg  50  of the disposable vaginal speculum  20 , sized to retain the enclosure  86  in a manner that is conventionally known, as indicated by arrow  162 . 
     Next and referring to  FIGS. 7 and 8 , the protective sheath  144  is deployed by detaching the elastic band  152  from the supporting tabs  148  and notches  156 , arrows  164 , in order to release the sheath from its stored compressed condition on the sheath supporting member  104 . Following the release of the elastic band, the tail  174 ,  FIG. 1 , of the deployed protective sheath  144  is then pulled downwardly so as to cover the depending cord and the in-line switch portions of the illumination assembly  24 , as shown by arrows  168  in  FIG. 8 . 
     The protective sheath  144  is shaped so as to permit the sheath to be easily pulled over the illumination assembly, including the in-line switch assembly  85 , as shown by arrows  168 . The physician can then use the use the system  10  to conduct an examination of the patient in the conventional manner. The illumination assembly  24  is energized by activating switch  91  of the in-line switch assembly  85 , which can easily be activated through the protective sheath  144  while the sheath covers this portion of the assembly. 
     Following examination and referring to  FIG. 9 , the illumination assembly  24  is turned off and the transformer  98  is disconnected from the remainder of the stem  10 . The remainder of the assembly can then be placed over a refuse container  176 , holding the extending proximal end of the cord  93  of the illumination assembly  24  and pulling downwardly, the illumination assembly can be released from the disposable speculum  20  such that the speculum and the attached protective sheath  144  can be easily discarded, shown by arrow  172 . 
     PARTS LIST FOR FIGS.  1 – 9   
     
         
           10  disposable vaginal speculum system 
           20  disposable vaginal speculum 
           24  illumination assembly 
           38  fixed blade member 
           42  movable blade member 
           46  slide member 
           50  hollow leg 
           54  forked upper end 
           58  lever portion 
           62  ratchet mechanism 
           66  lower tongue 
           70  slot 
           72  slot 
           74  interior curved light bar 
           82  lamp housing 
           85  in-line illumination switch assembly 
           86  enclosure 
           87  cord 
           89  cover housing 
           90  plug 
           91  switch 
           93  cord 
           94  plug 
           95  cord 
           96  gripping portion/strain relief 
           98  transformer 
           100  protective sheath assembly 
           102  tubular supporting portion 
           104  sheath supporting member 
           108  open end-distal 
           112  open end-proximal 
           116  pawl 
           120  opening 
           128  engagement tooth 
           129  base portion 
           134  annular receiving portion 
           138  supporting surface 
           144  protective sheath 
           148  support tabs 
           152  elastic band 
           166  notches 
           160  arrow 
           162  arrow 
           178  arrow 
           172  arrow 
           174  tail 
           175  O-ring 
           176  refuse container 
       
    
     Though the present invention has been described with reference to the preferred mode as illustrated in the drawings, it will be understood by one skilled in the art that various changes in detail may be effected therein without departing from the spirit and scope of the invention as defined by the claims. For example, it should be readily apparent that other designs can be implemented for supporting the protective sheath prior to release. For example and in lieu of the support tabs, a strap, a single tab (not shown) or a cover could be used. Alternatively, adhesives, tape or other bonding means could also be substituted.