Patent Publication Number: US-2023141460-A1

Title: Integrated illumination assembly for handheld medical devices

Description:
CROSS REFERENCE TO RELATED APPLICATIONS 
     This application is a divisional of U.S. Ser. No. 16/800,578, filed Feb. 25, 2020, which is a non-provisional application of U.S. Ser. No. 62/810,976, filed Feb. 27, 2019, the entire contents of which are incorporated by reference. 
    
    
     TECHNICAL FIELD 
     The application is generally directed to the field of diagnostic medicine and more specifically to handheld medical devices or instruments equipped with an integrated illumination assembly. 
     BRIEF BACKGROUND 
     Attempts have been made to improve the design of vaginal speculums, which are used for examining the cervix of female patients. Known specula for this purpose have been made in accordance with a number of designs. For example, a Graves speculum is typically defined by a top blade member and a bottom blade member that are coupled to each other and whose relative spacing can be adjusted by an articulation or moving mechanism for purposes of dilating the female patient. A distal blade end of the speculum extends to the patient and the medical target is viewed through an aperture which is formed between the top and bottom blade members at the proximal end of the speculum. An illumination assembly disposed within the speculum includes a light source that facilitates viewing of the intended target. 
     In prior versions, illumination assemblies were tethered to the speculum and coupled to a remote power source as described by Strong et al. (U.S. Pat. No. 7,081,090 B2). These illumination assemblies include a housing retained in a receiving cavity formed in a handle portion of the speculum. The output of a contained incandescent lamp is coupled to the proximal end of a curved light transmissive pipe that directs the output from the proximal end of the curved light pipe to a distal end and to the intended medical target. The housing of the illumination assembly is tethered by a cord to a remote power source and an in-line switch allows a user to selectively energize the contained incandescent lamp. 
     In accordance with more recent developments, a compact illumination assembly has been introduced that replaces the previously described tethered version. This design, which is described in U.S. Pat. No. 8,821,395, includes an LED disposed within a housing along with at least one rechargeable battery. The housing is disposed within a cavity formed in the handle portion of the speculum and like the prior described tethered illumination assembly, the emitted output of the retained LED is optically coupled to the proximal end of a curved light transmissive pipe provided at the closed end of the handle portion for direction to the medical target. 
     Still other designs have since been developed that include an integrated illumination assembly fixedly secured to the handle portion or other feature of the speculum. The housing of the illumination assembly retains a light source, as well as a compact power supply. A releasable tab portion extends from the housing. When the releasable tab portion is pulled by the user, the contained light source is automatically energized. The speculum and illumination assembly are designed in this case for use as a single use or single patient device. 
     For specula and illumination assemblies that are deemed to be disposable (single patient or single use), and due to existing regulations in the United States and a number of other countries, the contained batteries must be removed before recycling. Depending on the location of the illumination assembly within the vaginal speculum, removal of the contained batteries can be difficult and time intensive. 
     Accordingly, there is a pervasive and ongoing need in the field to improve the efficiency and structural integrity of single use or single patient vaginal specula. There is also a need to develop a speculum with a portable illumination assembly that enables recyclability, while further permitting the contained batteries to be easily removed while the illumination assembly is still retained on or within the speculum. 
     There is a further present and ongoing need in hospitals and other medical care facilities to prevent the spread of diseases and contaminants through the use of single use or single patient medical devices for purposes of diagnosis and examination, as opposed to the various risks and overall inconvenience involved with the cleaning and reuse of dedicated medical devices between patients. 
     BRIEF DESCRIPTION 
     Therefore and according to one aspect of the present invention, there is provided a vaginal speculum comprising a first blade and a second blade, each of the first and second blades having a trough-shaped blade section. A handle portion extends downwardly from the second blade that permits the speculum to be handheld. An illumination assembly includes a housing that retains at least one battery, as well as a light source disposed within a curved arm extending from the housing. The housing is mounted into the upper open end of a through cavity of the handle portion with the curved arm being supported by the bottom blade. The curved arm is sized and configured to position an LED at the distal end of the curved arm within the trough-shaped blade section of the second blade. 
     According to at least one embodiment, a plurality of batteries are releasably disposed within the housing of the illumination assembly. The housing can include a hinged cover in which the batteries can be supported by an integral feature provided in the housing interior. The hinged cover can be opened, even while the illumination assembly is supported within the speculum, to effect release of the batteries following use. According to one embodiment, a tool can access and open the hinged cover from the lower open end of the through cavity. According to another embodiment, a supporting feature of the contained batteries can be made part of a battery release member, the latter having a portion that extends from the housing. Following use of the speculum, an extending portion of the releasable member can be accessed from the open lower end of the handle portion in order to effect battery release prior to recycling the speculum. 
     According to at least one embodiment, a releasable tab member can also extend from the housing of the illumination assembly, the tab member being configured to energize the contained light source when pulled from the housing. In at least one version, the battery release member includes at least one feature that supports the releasable tab member such that the releasable tab member can be pulled from the housing in order to energize the contained light source and permit an examination to be conducted. Following use, the extending portion of the battery release member can be pulled from the housing to release the contained batteries prior to recycling the vaginal speculum, including the mounted illumination assembly. 
     Alternatively, the upper end of the housing of the illumination assembly can be accessed from the upper open end of the through cavity of the speculum. In one version, the upper end of the housing can include a recess or other gripping area to enable the housing to be extracted. In at least one embodiment, the housing or the through cavity can include a set of frangible tabs or similar supporting features. Removal of the housing breaks or disables the frangible tabs and prevents the illumination assembly and/or the speculum from being reused. 
     According to at least one version, the curved arm of the illumination assembly is integral to the housing with at least one LED being disposed at the distal end of the arm. A recess formed in the bottom blade member is sized and shaped to accommodate a portion of the curved arm and promote illumination toward the distal end of the speculum. Unlike previously known light pipes, there is no need to provide a material that promotes internal reflection of emitted light, since the LED is already disposed at the distal end of the curved arm. 
     According to another aspect, there is provided an illumination assembly for use in a medical device. The illumination assembly comprises a housing having an upper end, an opposing lower end and a curved arm extending from the housing. At least one battery is disposed within the housing and an LED is mounted at a distal end of the curved arm. The housing is sized and shaped to be fitted within the open upper end of a handle portion of the medical device, with the upper end of the housing having a width dimension that is larger than the width dimension of the open upper end of the handle portion. Preferably, the illumination assembly can be fixedly attached or integrated as part of the medical device with the illumination assembly and the medical device both being intended for single patient or single use. The medical device is preferably a hand-held diagnostic instrument such as, but not limited to a vaginal speculum, colposcope, sigmoidoscope, laryngoscope, rhinoscope, anoscope, and skin measuring microscope. The medical device includes an examination portion, such as a blade, into which the curved arm of the housing extends, enabling the supported LED to direct light to a medical target. 
     According to at least one version, the housing of the illumination assembly includes a hinged cover. In at least one embodiment, an extending battery release member enables the at least one battery to be removed from the housing without having to first remove the illumination assembly from the handle portion of the medical device. According to at least one embodiment, the medical device can include at least one guide positioned and configured to assist in the transmission of light from the illumination assembly to the medical target of interest. The herein described illumination assembly is configured and designed to be fitted into a plurality of different medical devices, thereby creating a suite of recyclable products that can be configured for single or single patient use. 
     According to yet another aspect, there is provided a method for examining a patient using a recyclable medical device. The medical device includes an examination section and a handle portion downwardly extending from the examination section. An illumination assembly is disposed within the upper open end of a through cavity of the handle portion. According to the method, a releasable tab portion can be pulled from the open lower end of the handle portion to cause energization of an LED disposed at a distal end of an extending arm of the illumination assembly, with the arm being supported by the examination section. Following an examination procedure, one end of a battery release member can be engaged from an lower open end of the cavity, causing at least one battery to be withdrawn from the illuminator assembly and without first removing the illumination assembly from the device. In at least one version, the battery release member also retains the releasable tab portion. 
     Alternatively, the illumination assembly can be removed directly from the opened upper end of the handle portion. In at least one version, a set of frangible tabs or similar support features can be provided on the illumination assembly housing and/or within the receiving slot of the handle portion of the medical device. The removal of the illumination assembly breaks or otherwise disables the tabs and renders them non-functional, thus guaranteeing that the illumination assembly and/or the medical device cannot be reused. 
     Preferably, all of the components of the device are disposable, enabling the illumination assembly and medical device to be recycled all at one time. 
     The inclusion of the open ended cavity in the upper end of the handle portion, as well as the frangible tabs simplifies alignment of the illumination assembly during manufacture of the medical device. That is, no special alignment features are required between the handle portion and the illuminator assembly. 
     The herein described improvements permit the handle portion of a sigmoidoscope, anoscope, laryngoscope, vaginal speculum or other hand-held medical instrument to be made smaller and more compact. Though less material is required, structural integrity of the medical device is maintained and in fact improved for its intended use. 
     Another advantage provided by the herein described device is that the batteries can be easily removed following use, easing the recycling process for the medical device, including contained illumination assembly. 
     In addition, having the LED disposed at the distal end of the extending arm enables the medical device and illumination assembly to be made from materials that do not necessarily require or promote light transmission. 
     Consequently, the herein described speculum or other medical device can be molded using lower strength plastic materials, such as polypropylene. This provides yet another advantage in that as a recyclable material, polypropylene is clean burning. In addition, materials that were required for light transmission were inherently brittle. The materials that can be used in the herein described speculum or other hand-held medical device are significantly less brittle and have poor light transmissive capabilities. However and because light transmissive qualities are not critical due to direct illumination, these materials can now be considered for use, which aids in manufacturability and product life. 
     According to yet another advantage, a suite of single use or single patient medical devices can be commonly equipped with an integrated illumination assembly as described herein, reducing the risk of contamination or disease associated with the cleaning or lack of cleaning of reusable devices. 
     These and other features and advantages will be readily apparent to the reader from the following Detailed Description, which should be read in conjunction with the accompanying drawings. 
    
    
     
       BRIEF DESCRIPTION OF THE DRAWINGS 
         FIG.  1 ( a )  is a rear perspective assembly view of a known vaginal speculum, including a portable illuminator; 
         FIG.  1 ( b )  is the rear perspective view of the vaginal speculum of  FIG.  1 ( a ) , with the portable illuminator assembled; 
         FIG.  1 ( c )  is a side elevational view, taken in section, of the handle portion and a section of the lower blade member of the vaginal speculum of  FIGS.  1 ( a ) and  1 ( b ) ; 
         FIG.  2    is a rear perspective view of a vaginal speculum made in accordance with aspects of the invention; 
         FIG.  3    depicts a side by side comparison between a lower blade member of the known speculum of  FIGS.  1 ( a )- 1 ( c )  and the speculum of  FIG.  2   ; 
         FIG.  4 ( a )  is a side elevation view of the vaginal speculum of  FIGS.  2  and  3   , including an integrated illumination assembly; 
         FIG.  4 ( b )  is a rear perspective view of the vaginal speculum of  FIGS.  2 - 4   ( a ); 
         FIG.  5 ( a )  is a rear facing view of the vaginal speculum of  FIGS.  2 - 4   ( b ); 
         FIG.  5 ( b )  is a front facing view of the vaginal speculum of  FIGS.  2 - 5   ( a ); 
         FIG.  6    is a rear perspective enlarged view of the lower blade member of the speculum of  FIGS.  2 - 5   ( b ), including the illumination assembly; 
         FIG.  7    is a rear facing view of the lower blade member and illumination assembly of  FIG.  6   ; 
         FIG.  8    is a top facing view of the proximal end of the lower blade member and handle portion of the speculum of  FIGS.  2 - 7   ; 
         FIG.  9    is a front perspective view of the illumination assembly that is only partially shown in  FIGS.  2     6  and  7 ; 
         FIG.  10    is a rear perspective view of the illumination assembly of  FIG.  9   , with a portion of the cover broken away for clarity; 
         FIG.  11    is a bottom perspective view of a vaginal speculum in accordance with other aspects of the invention; 
         FIG.  12 ( a )  is a bottom perspective view of the vaginal speculum of  FIG.  11   ; 
         FIG.  12 ( b )  is an enlarged view of the lower open end of the handle portion of the speculum of  FIG.  12 ( a ) , partially depicting a battery release member; 
         FIG.  13    is a perspective view of the battery release member of  FIG.  12 ( b ) ; 
         FIG.  14    is a side perspective view of another handheld medical device equipped with an illumination assembly in accordance with aspects of the present invention; 
         FIG.  15    is a partially exploded view of the handheld medical device of  FIG.  14   ; 
         FIG.  16    is a side perspective view of another handheld medical device equipped with an illumination assembly in accordance with aspects of the present invention; 
         FIG.  17    is a partially exploded view of the handheld medical device of  FIG.  16   ; and 
         FIG.  18    depicts an illumination assembly in accordance with aspects of the invention as used in conjunction with a suite of disparate and recyclable handheld medical devices. 
     
    
    
     DETAILED DESCRIPTION 
     The following relates to an illumination assembly made in accordance with various embodiments that can be configured for use in a plurality of recyclable single use or single patient medical devices or instruments, particularly those devices with a handle portion that permits one-handed operation. A detailed description of an illumination assembly as integrated into a specific medical device, namely a disposable and recyclable vaginal speculum is first discussed. However, it will be readily apparent that the inventive aspects described herein are similarly applicable for incorporation into a number of other medical devices. In addition and throughout the course of discussion, several terms are used in order to provide a suitable frame of reference with regard to the accompanying drawings. These terms, which include “first”, “second”, “top”, “bottom”, “inner”, “outer”, “above”, “below”, “distal” and “proximal” among others, are not intended to be overly limiting of the invention, except where so specifically indicated. In addition, the accompanying drawings are intended to depict salient features of the present invention. In this regard, the drawings are not necessarily to scale and should not be relied upon for purposes of scaling or sizing. 
     For purposes of background and with reference to  FIGS.  1 ( a )- 1 ( c ) , there is shown a known medical device and more specifically, a vaginal speculum  100 . The vaginal speculum  100  is defined by a first or top blade member  104 , as well as a second or bottom blade member  108 . Each of the blade members  104 ,  108  include a distal end  112  having a trough-shaped blade portion  118 , as well as an opposing proximal end  116 . The top and bottom blade members  104 ,  108  are coupled together by means of an articulation or moving mechanism, described in greater detail below. 
     A handle portion  120  extends downwardly from the proximal end  116  of the bottom blade member  108 . The handle portion  120  is defined by a shape that permits gripping and use of the speculum  100  by a single hand of the user. The handle portion  120  is fully enclosed with the exception of an open lower end  128 . An enclosed receiving cavity  126  extends from the open lower end  128  to a closed upper end  132  of the handle portion  120 . A curved light pipe  136  extending from the closed upper end  132  of the handle portion  120  is defined by opposing proximal and distal ends  138 ,  140 , respectively. The light pipe  136  extends along a necked portion  144  of the bottom blade member  108  defined between the handle portion  120  and the trough-shaped blade portion  118  of the bottom blade member  108 . A coupling and aligning feature is provided at the closed upper end  132  of the enclosed receiving cavity  126 , which includes centering fingers  148  disposed at the closed upper end  132  that are aligned with a lens  152  formed at the proximal end  138  of the light pipe  136 . As noted, the light pipe  136  extends in a curved configuration along the necked portion  144 , as shown in  FIG.  1 ( c ) , and is made from an optically clear light transmissive material, such as an acrylic, that promotes internal reflection. 
     A known portable illumination assembly  160  is advanced within the open lower end  128  of the enclosed receiving cavity  126  of handle portion  120 . The illumination assembly  160  is defined by a housing  162  having an upper portion  164  that retains a light source (not shown) adjacent an upper end  163  and a lower portion  166 . The lower portion  166  includes at least one charging contact  168  that enables a contained battery (not shown) to be recharged. The upper portion  164  of the housing  162  is sized to be fitted within the receiving cavity  126  of the handle portion  120  through the open lower end  128 . The upper portion  164  includes an exterior slide switch  165  that causes the contained light source to be energized when the illumination assembly  160  is sufficiently advanced into the enclosed receiving cavity  126 . The illumination assembly  160  is further advanced until the upper end  163  of the housing  162  is aligned within the centering fingers  148  and the light source of the illumination assembly  160  is aligned with the lens  152  and the proximal end  138  of the curved light pipe  136 . Further axial movement is prevented by the lower portion  166  of the housing  162 , which is larger in width than the open lower end  128  of the receiving cavity  126 . Further details relating to the illumination assembly  160  are described in U.S. Pat. No. 8,821,395, which is incorporated in its entirety. When the illumination assembly  160  is powered and the contained light source is energized, such as by the exterior slide switch  165 , the emitted light is directed through the lens  152  and is transmitted by internal reflection through the curved light pipe  136 . 
     Referring to  FIGS.  1 ( a )- 1 ( c ) , a moving or articulation mechanism is provided to enable the spacing of the top and bottom blade members  104 ,  108  to be selectively adjusted for purposes of adequately dilating a patient. This moving mechanism includes a lever portion  170  that is attached to the proximal end  116  of the top blade member  104  and a yoke  180  that is mounted to the proximal end  116  of the bottom blade member  108  and the handle portion  120 . The lever portion  170  is integral to the top blade member  104  and extends downwardly relative to the remainder of the top blade member  104  at a reflexed angle. The lever portion  170  includes a viewing aperture  174 , as well as a lower tab  176  disposed beneath the viewing aperture  174 , the lower tab  176  having a slot  178 . 
     The yoke  180  includes a yoke portion  182  defined by a pair of upwardly extending spaced arms  184 , the upper ends of the arms  184  being pivotally attached to the proximal end  116  of the top blade member  104 . The yoke  180  further includes a slide member  186  downwardly extending from the lower end of the yoke portion  182 . The slide member  186  is movably disposed within a vertical slot  190  formed on a rear facing side of the handle portion  120 . The slide member  186  further includes a lower locking member  194  sized and configured to engage a set of spaced teeth  196  formed on opposing sides of the vertical slot  190 , as well as an arcuate pawl arm  198  between the yoke portion  182  and the slide member  186  that extends proximally away from the proximal end  116  of the speculum  100 . The arcuate pawl arm  198  is curved and includes a set of spaced ratchet teeth  199  that are configured to engage the slot  178  formed on the lower tab  176  of the lever portion  170 . The proximal end  116  of the lower blade member  108  is further defined by a recessed portion  202  that is sized to retain the yoke portion  182  and permit viewing through the viewing aperture  174 . 
     In use, the moving mechanism enables the spacing of the top and bottom blade members  104 ,  108  to be adjusted. The bottom blade member  108  is fixed while the position of the top blade member  104  can be adjusted by engaging the slide member  186  and elevating or lowering the yoke  180  against the pivotally attached upper blade member  104 . The angular position between the top and bottom blade members  104 ,  108  can be further adjusted by pushing upwardly against the arcuate pawl arm  198  and varying the position of the arm  198  relative to the slot  178  of the lower tab  176  of the lever portion  170 . 
     The illumination assembly  160  is disposed within the enclosed receiving cavity  126  of the handle portion  120  in which the upper end  163  of the housing  162  is aligned with the lens  152  via the centering fingers  148 . Illumination is directed from the light source (not shown) through the lens  152  and the proximal end  138  of the curved light pipe  136  with the transmitted light being emitted from the distal end  140  of the curved light pipe  136  toward the distal end  112  of the speculum  100  and the medical target of interest. According to one version, the distal end  140  of the curved light pipe  136  is angled to prevent the incidence of back reflection (glare) relative to the user. 
     With the foregoing background, a vaginal speculum  1000  made in accordance with an exemplary embodiment and having an integrated illumination assembly  1100  is shown in  FIGS.  2 - 10   . First and referring to  FIGS.  2 ,  4   ( a ) and  4 ( b ), the speculum  1000  is defined by an upper or first blade member  1004  and a lower or second blade member  1008 . Each of the upper and lower blade members  1004 ,  1008  is further defined by a distal end  1012  having a trough-shaped blade portion  1016 , as well as an opposing proximal end  1018 . The speculum  1000  further includes a handle portion  1020  downwardly extending from the proximal end  1018  of the lower blade member  1008 . The handle portion  1020  is sized to enable the speculum  1000  to be held in a single hand of the user/caregiver. 
     Like the prior described version in  FIGS.  1 ( a )- 1 ( c ) , the vaginal speculum  1000  includes a moving or articulation mechanism that enables the spacing of the upper and lower blade members  1004 ,  1008  to be selectively adjusted for purposes of adequately dilating a patient. As shown in  FIGS.  2 ,  4   ( a ) and  4 ( b ), this moving mechanism includes a lever portion  1064  that is attached to the proximal end  1018  of the upper blade member  1004  and a yoke  1080  mounted to the proximal end  1018  of the lower blade member  1008  and the handle portion  1020 . The lever portion  1064  extends downwardly relative to the upper blade member  1004  at a reflexed angle and includes a viewing aperture  1068 , as well as a lower tab  1070  disposed beneath the viewing aperture  1068 , the lower tab  1070  having a slot  1074 . Preferably, the lever portion  1064  is integral with the housing  1004 . According to this embodiment, the upper and lower blade members  1004 ,  1008  and the handle portion  1020  are each made from a lightweight plastic material, which is preferably moldable. Examples of suitable materials that further permit recyclability of the speculum  1000  include polyethylene, polyamide, and acrylic. 
     The yoke  1080  includes a yoke portion  1084  defined by a pair of upwardly extending spaced arms  1085 , the upper ends of the extending arms  1085  being pivotally attached to the proximal end  1018  of the upper blade member  1004 . The yoke  1080  further includes a slide member  1086  downwardly extending from the lower end of the yoke portion  1084 . The slide member  1086  is movably disposed within a vertical slot  1090  formed on a rear facing side of the handle portion  1020 . The slide member  1086  further includes a lower locking member  1094  sized and configured to engage a set of spaced teeth  1096  formed on opposing sides of the vertical slot  1090 . An arcuate pawl arm  1098 , disposed between the yoke portion  1084  and the slide member  1086 , extends proximally away from the proximal end  1018  of the speculum  1000 . The arcuate pawl arm  1098 , which is curved, includes a set of ratchet teeth  1099  that engage the slot  1074  formed on the lower tab  1070  of the lever portion  1064 . 
     As in the prior described version of  FIGS.  1 ( a )- 1 ( c ) , the proximal end  1018  of the lower blade member  1008  includes a recessed portion  1056  that is sized to retain the yoke section  1084  and permit viewing through the viewing aperture  1068 . To provide additional stability and as shown in  FIGS.  2 ,  3 ,  6  and  8   , the recessed portion  1056  at the proximal end  1018  of the lower blade member  1008  is further defined by a pair of channels  1060  that include guiding features such as shoulders  1062 , each suitably sized and configured to engage, axially guide and stabilize the upwardly extending arms  1085  of the yoke portion  1084 . 
     In use, the moving mechanism enables the spacing of the upper and lower blade members  1004 ,  1008  to be selectively adjusted. The lower blade member  1008  is fixed while the position of the upper blade member  1004  can be adjusted by engaging the locking member  1094  and pushing or pulling the slide member  1086  in the vertical slot  1090 . Movement of the slide member  1086  elevates or lowers the yoke portion  1082 , as guided by the channels  1060  and shoulders  1062 , against the pivotally attached upper blade member  1004 . The angular position between the upper and lower blade members  1004 ,  1008  can be further adjusted by pushing the arcuate pawl arm  1098  upwardly relative to the slot  1074  formed in the lower tab  1070  of the lever portion  1064  and shifting the position of the lever portion  1064  relative to the set of ratchet teeth  1099  of the arcuate pawl arm  1098 . 
     According to this embodiment and as shown in  FIGS.  3  and  8   , the handle portion  1020  is defined by an axial cavity  1024  that is fully enclosed with the exception of the open and opposing upper and lower ends  1028 ,  1032 . The interior of the enclosed cavity  1024  can include at least one guide rail. According to this embodiment, a pair of guide rails  1036  (only one pair being shown) provided on opposing sides of the enclosed cavity  1024  extends over substantially the entire axial length of the enclosed cavity  1024 . The number and spacing of these latter features can be suitably varied for use in aligning and retaining an illuminator assembly  1100 . 
     As shown in  FIGS.  5 ( a ) and  5 ( b ) ,  6  and  7 , the illumination assembly  1100  is intended to be fitted within the enclosed cavity  1024  of the handle portion  1020  and more specifically into the open upper end  1028 . The illumination assembly  1100  is defined by a housing  1104  (partially shown in these figures), as well an extending curved arm  1112  that retains a light source. According to this embodiment, the distal end  1116 ,  FIG.  5 ( b ) , of the extending curved arm  1112  retains an LED (not shown). The extending curved arm  1112  is shaped and configured to be fitted onto a necked portion  1044  of the lower blade member  1004 , which is intermediately disposed between the handle portion  1020  and the trough-shaped blade section  1016  of the lower blade member  1008 . According to this embodiment, at least a portion of the lower blade member  1008  in the necked portion  1044  is recessed to receive a distal portion of the extending curved arm  1112  in order to improve and effectively direct illumination from the retained light source toward the distal end  1012  of the speculum  1000 . As shown in  FIGS.  5 ( a ) and  5 ( b ) , the positioning of the illumination assembly  1100  within the speculum  1000  permits illumination to be directed toward the intended target, but does not interfere with viewing through the rear viewing aperture  1068 . 
     Further details of the illumination assembly  1100  are provided with reference to  FIGS.  9  and  10   . According to this embodiment, the illumination assembly  1100  includes the housing  1104 , which is defined by an upper end  1107  and an opposing lower end  1109 . The housing  1104  further includes an upper flanged section  1124  having a width that is larger than the width of the open upper end  1028  of the enclosed receiving cavity  1024  of the handle portion  1020 , as shown in  FIGS.  5  and  7   . The upper end  1107  of the housing  1104  supports the extending curved arm  1112 , which as noted retains an LED (not shown) at a distal end  1116  of the arm  1112 . According to this embodiment, the curved arm  1112  is integral to the housing  1104  with the housing  1104  and extending arm  1112  being formed from a moldable plastic material, such as polyethylene (PETE) or polypropylene. It will be understood, however, that the extending arm  1112  can be alternatively and separately attached to the upper end  1107  of the housing  1104  by suitable techniques such as adhesives, welding, or fasteners. 
     The housing  1104  is defined by an interior that retains at least one battery (not shown). According to this embodiment, a pair of batteries such as Panasonic CR 2032 lithium coin batteries (+3 volts) are retained in side by side relation in adjacently spaced retaining peripheral slots  1125  integrally provided on an inner surface of the housing  1104 . An electrical contact  1126 , configured within the interior of the housing  1104 , includes a first end arranged to engage the retained batteries, wherein the electrical contact  1126  extends along the length of the housing  1104  and into the interior of the curved arm  1112  with a second end of the electrical contact  1126  being arranged to engage the distally retained LED (not shown). 
     The housing  1104  further includes a cover  1120 , which according to this embodiment includes an intermediate hinge  1122  disposed adjacent the upper end  1107  of the housing  1104 . Though not shown, the housing  1104  can further include at least one and preferably two or more frangible tabs or similar features to secure the housing  1104  within the enclosed cavity  1024  of the handle portion  1020 . Removal of the housing  1104  by pulling the assembly  1100  from the enclosed cavity  1024  breaks or otherwise disables the frangible tabs and prevents the illuminator housing  1104  from being reinstalled into the receiving cavity  1024 . According to this embodiment, a recessed portion  1128 ,  FIG.  7   , of the upper flanged section  1124  assists in gripping the illumination assembly  1100  to enable permanent removal of the illumination assembly  1100  from the speculum  1000 . 
     In use, the illumination assembly  1100  is disposed within the open upper end  1028  of the receiving cavity  1020  of the speculum  1000  with the extending curved arm  1112  being supported by the necked portion  1044  of the lower blade member  1008 . The upper flanged portion  1024  prevents the housing  1104  from being advanced too far into the receiving cavity  1020  or falling through the cavity  1020 , the housing  1104  being guided by the rails  1036 . The frangible tabs (not shown) secure the illumination assembly  1100  in place. 
     Preferably, the housing  1104  is fully enclosed with the exception of a slot formed at the lower end  1109  that permits the passage of an extending tab member  1150 , partially shown in  FIG.  4 ( a ) . The tab member  1150  is made from an electrically inert material, such as plastic, and includes a distal portion disposed within the interior of the housing  1104 . More specifically, the distal portion is positioned between the end of the electrical contact  1126  and the retained battery. The extending tab member  1150  includes a proximal end, the latter extending outwardly of the open lower end  1032  of the handle portion  1020 . When the proximal end is pulled by a user and the tab member  1150  is removed from the housing  1104 , engagement is created between the contained batteries and the first end of the electrical contact  1126 , energizing the supported LED in the extending curved arm  1112 . Illumination is directed toward the distal end  1012  of the speculum  1000  as the recess formed in the necked portion  1044  of the lower blade member  1008  assists in maximizing uniform distribution of light emitted by the LED. 
     Following its intended use the speculum  1000 , including the illumination assembly  1100 , can be disposed of for recycling. As noted and due to various environmental regulations and standards, the batteries should first be separated from the illumination assembly  1100 . According to this described embodiment, there are two (2) techniques available for removing the contained batteries. First, the illumination assembly  1100  can be removed from the receiving cavity  1020  by gripping the upper flanged portion  1024  of the housing  1104  and extracting the assembly  1100  from the handle portion  1020 . In so doing, the frangible tab features are disabled as a result of removing the housing  1104  from the open upper end  1028  of the receiving cavity  1024 . The hinged cover  1120  can then be opened and the batteries can be removed from the retaining slots  1168 . 
     According to a second technique, the batteries can be removed from the housing  1104  without first removing the illumination assembly  1100  from the speculum  1000 . A tool (not shown) can be extended upwardly into the receiving cavity  1020  through the open lower end  1032  of the handle portion  1020  and more specifically into the open slot formed at the lower end  1109  of the housing  1104 . The tool is shaped to pry open the hinged cover  1120 , which drops the batteries which are vertically arranged, through the open lower end  1032  of the handle portion  1020 . The speculum  1000  and illumination assembly  1100  can then be disposed of for purposes of recycling, without requiring further disassembly. 
     A further variation of a speculum  1200  having an integrated illumination assembly  1300  is shown with reference to  FIGS.  11 - 13   . For purposes of this discussion, similar parts are labeled with the same reference numerals for the sake of clarity. According to this version, the lower open end  1032  of the handle portion  1020  is recessed along one wall  1208  of the handle portion  1020  to permit finger access to a battery release member  1160 , the latter extending downwardly from the lower end  1109 ,  FIG.  10   , of the housing  1104 ,  FIG.  10   , of the illumination assembly  1300 , in addition to the extending tab member  1150 . According to this embodiment and in lieu of a separate tool, the battery release member  1060  of the illumination assembly  1300  can be pulled entirely from the housing  1104 , and more specifically the lower end  1109 . 
     With reference to  FIG.  13   , the battery release member  1160  according to this embodiment is defined by a single component that includes a battery engagement portion  1164  at its distal end, which includes a pair of interconnected loops  1168 . The battery engagement portion  1164  is sized to fit within the interior of the housing  1104  and the loops  1168  are each sized to peripherally cover one of the retained batteries (not shown). An intermediate planar portion  1172  of the battery release member  1160  extends to a proximal or user engagement end  1176  that extends proximate to the recess  1208  at the lower end of the handle portion  1020 . According to this described embodiment, the user engagement end  1176  includes a loop  1180  that is appropriately sized to permit an extending proximal end of the releasable tab member  1150  to extend therethrough as well as a guide tab  1178 . In this version, the extending proximal end of the releasable tab member  1150  is caused to extend over the guide tab  1178  at an acute angle relative to the handle portion  1020 , as shown in  FIG.  11   . 
     The speculum  1200  and illumination assembly  1300  are otherwise no different structurally than the previously described versions  1000  and  1100 , respectively. When the illumination assembly  1100  is mounted within the enclosed cavity  1024  of the handle portion  1020 , the user engagement end  1176  of the battery release member  1160  is accessible from the open lower end  1032  of the handle portion  1020  via the recess  1208 . 
     As in the preceding, the releasable tab member  1150  extends downwardly from the interior of the housing  1104  such that the proximal end of the tab member  1150  can be accessed from the open lower end  1032  of the receiving cavity  1024  of the handle portion  1020 , as shown in  FIG.  11   . When the tab portion  1150  is pulled from the housing  1104 , the electrical contact  1126 ,  FIG.  10   , is caused to engage the contained batteries and energize the retained LED. The releasable tab member  1150  is pulled from the speculum  1200  while the battery release member  1160  remains in place. 
     Following examination, the batteries can be removed by accessing the guide tab  1178  and pulling the user engagement end  1176  of the battery release member  1160 . This pulling action withdraws the battery release member  1160 , as well as the contained batteries, which drop from the lower end  1109  of the housing  1104  through the open lower end  1032  of the handle portion  1020 . Alternatively and as previously described, the user can separately remove the illumination assembly  1300  by engaging the recessed portion  1128  of the upper flanged section  1124  to pull the illumination assembly  1300  from the handle portion  1020  of the speculum  1000 . Once removed, the hinged cover  1120  can be opened and the batteries can be removed prior to recycling the illumination assembly  1300 . 
     As noted, the herein described illumination assembly (whether  1100  or  1300 ) can be used in conjunction with other hand-held medical instruments or devices other than a vaginal speculum, the latter being merely an embodiment. For example and with reference to  FIGS.  14  and  15   , an illumination assembly  1100  is depicted for use with a laryngoscope  1500 , the latter instrument being used typically for examining the throat of a patient. The laryngoscope  1500  according to this embodiment is defined by a handle or handle portion  1508  that downwardly extends from the proximal end of a single curved blade  1514 , the latter being configured and shaped for examining the throat of a patient (not shown). The handle  1508  is shaped and configured to permit one-handed operation of the instrument  1500  by a practitioner or care provider. The handle  1508  and blade  1514  according to this version are made as a unitary component made from a recyclable plastic, such as polyethylene. 
     The salient features of the illumination assembly  1100  are as previously described. That is and as partially shown in  FIG.  14   , the illumination assembly  1100  is defined by a housing  1104  having a width dimension at the top or upper portion of the housing  1104  that is wider than a cavity formed in the top or upper portion of the unitary handle  1508 . A curved arm  1112  extends outwardly from the housing  1104 , the latter being shaped and configured to extend partially within the confines of the curved blade  1514 . At least one LED  1190  mounted at the distal end of the curved arm  1112  is electrically coupled to a set of compact batteries (not shown) retained within the housing  1104  of the illumination assembly  1100 . According to at least one version, both the illumination assembly  1100  and the laryngoscope  1500  can be made from the same recyclable plastic material. 
     According to this embodiment, the output of the LED  1190  is optically coupled via a guide  1550 , the latter being retained within a pocket  1558  formed in the curved blade  1514  to direct light to the patient (not shown) being examined. The guide  1550  according to this embodiment is defined by a substantially conical shape and made from a light transmissive material, such as an acrylic, that is formed with a diffused end. The guide  1550  is configured to effectively direct emitted light from the LED  1190  to the distal end of the blade  1514  and subsequently the throat of the patient. 
       FIGS.  14  and  15    illustrates a laryngoscope  1500  having an adult (large) laryngoscope blade  1514 . A similar version, shown in  FIGS.  16  and  17   , depicts a laryngoscope  1600  having a smaller adult laryngoscope blade  1614 , which is inherently narrower dimensionally. In this latter version and in lieu of a conical guide, the LED  1190  of the contained illumination assembly  1100  is optically coupled with a guide in the form of a prism  1650 . The prism  1650  is made from a light transmissive material that is configured and positioned within a pocket or cavity  1658  formed in the blade  1614  of the laryngoscope  1600  in order to effectively direct emitted light from the contained illumination assembly  1100 , and more specifically the LED  1190 . 
     In each of the versions depicted in  FIGS.  14 - 17    and as in the prior embodiments described above, the illumination assembly  1100  (or  1300  or variants) is preferably configured for energization of the LED  1190  using an extending tab member that is accessible via an open end of the handle  1508 ,  1608  of the laryngoscope  1500 ,  1600 . Removal of the contained batteries can be realized using a tool (not shown) configured to open a hinged cover of the housing  1104  or alternatively via a battery release member (not shown), as previously described, which can be pulled to enable the contained batteries to drop through an open end at the bottom of the formed cavity in the handle of the instrument  1500 ,  1600 . Alternatively, the illumination assembly  1100  can be separately removed from the handle of the laryngoscope and the batteries can be removed by accessing the hinged cover of the housing  1104 . 
     According to this version, the instrument handle  1508 ,  1608  can further or alternatively include a frangible side cover  1520 ,  1620  to permit removal of the illumination assembly  1100  in order to remove the retained batteries from the housing  1104 . Preferably, removal of the side cover  1520 ,  1620  limits the structural capability of the instrument handle  1508 ,  1608  for continued use as an instrument handle, thereby preventing any subsequent reinstallation of the illumination assembly  1100 . In each of the above embodiments, the batteries can be removed separately prior to recycling of the instrument  1500 ,  1600 , including the illumination assembly  1100 . 
       FIG.  18    depicts the further use of an illumination assembly  1100  in conjunction with a number of disparate recyclable medical devices. Though the assembly  1100  is shown here, it will be understood that other variants can be utilized for this purpose. As shown, the illumination assembly  1100  includes a housing  1108 , as well as a curved arm  1112  extending from an upper end of the housing  1108  that retains an LED  1190  at its distal end, the LED  1190  being coupled electrically to a set of batteries  1196  that are retained in the housing  1108 . The housing  1108  can include a hinged cover, as well as a lower or bottom extending tab portion or member  1150  that can be used as a switch to energize the LED  1190  when pulled by a user. A battery release member  1160 , as described above, is also provided to enable the contained batteries  1196  to be withdrawn from the housing  1104  in a manner, as previously described. As shown, the illumination assembly  1100  can be integrated within a vaginal speculum  1800 , a laryngoscope  1830 , in addition to a sigmoidscope  1840 , and an anoscope  1860 , each of the foregoing instruments being typically configured for examining a different medical target. This depicted incorporation enables a suite of hand-held medical instruments to be reserved for single use or single patient use and further enables recyclability. Still other hand-held medical devices, such as rhinoscopes and skin measuring microscopes, among others, can be similarly equipped. 
     PARTS LIST—FIGS.  1 - 18   
     
         
           100  vaginal speculum 
           104  first or top blade member 
           108  second or bottom blade member 
           112  distal end, blade members 
           116  proximal end, blade members 
           118  trough-shaped blade portion 
           120  handle portion 
           126  enclosed receiving cavity 
           128  open lower end 
           132  closed upper end 
           136  curved light pipe 
           138  proximal end, light pipe 
           140  distal end, light pipe 
           144  necked portion 
           148  centering fingers 
           152  lens 
           160  illuminator, portable 
           162  housing, illuminator 
           163  upper end 
           164  upper portion, illuminator 
           165  slide switch, exterior 
           166  lower portion, illuminator 
           168  charging contact, battery 
           170  lever portion 
           174  viewing aperture 
           176  lower tab 
           178  slot, tab 
           180  yoke 
           182  yoke portion 
           184  upwardly extending spaced arms 
           186  slide member 
           190  vertical slot 
           194  lower locking member 
           196  spaced teeth 
           198  arcuate pawl arm 
           199  teeth, ratchet 
           202  recessed portion 
           1000  speculum 
           1004  first or upper blade member 
           1008  second or lower blade member 
           1012  distal end 
           1016  trough-shaped blade portion 
           1018  proximal end 
           1020  handle portion 
           1024  axial cavity, enclosed 
           1028  open upper end 
           1032  open lower end 
           1036  guide rails 
           1044  necked portion 
           1056  recessed portion 
           1060  channels 
           1062  guiding features 
           1064  lever portion 
           1068  viewing aperture 
           1070  lower tab 
           1074  slot 
           1080  yoke 
           1084  yoke portion 
           1085  upwardly extending arms 
           1086  slide member 
           1090  vertical slot 
           1094  lower locking member 
           1096  teeth, spaced 
           1098  arcuate pawl arm 
           1099  ratchet teeth 
           1100  illuminator assembly 
           1104  housing 
           1107  upper end, housing 
           1109  lower end, housing 
           1112  curved arm 
           1116  distal end 
           1120  cover 
           1122  hinge, intermediate 
           1124  upper flanged section, housing 
           1125  retaining peripheral slots 
           1126  electrical contact 
           1128  recessed portion 
           1150  releasable tab portion 
           1160  battery release member 
           1164  battery engagement or support portion 
           1168  loops, interconnected 
           1172  outwardly extending portion 
           1176  user engagement end 
           1178  guide tab 
           1180  loop 
           1190  LED 
           1196  batteries 
           1200  speculum 
           1208  access slot 
           1300  illumination assembly 
           1500  laryngoscope 
           1508  handle 
           1514  blade 
           1520  side cover 
           1550  guide 
           1558  pocket 
           1600  laryngoscope 
           1608  handle 
           1614  blade 
           1620  side cover 
           1650  prism 
           1658  pocket or cavity 
           1800  vaginal speculum 
           1830  laryngoscope 
           1840  sigmoidoscope 
           1860  anoscope 
       
    
     It will be readily apparent that the foregoing description is exemplary of the inventive concepts. These and other variations and modifications are possible, as defined by the following claims.