Patent ID: 12220109

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 toFIGS.1(a)-1(c), there is shown a known medical device and more specifically, a vaginal speculum100. The vaginal speculum100is defined by a first or top blade member104, as well as a second or bottom blade member108. Each of the blade members104,108include a distal end112having a trough-shaped blade portion118, as well as an opposing proximal end116. The top and bottom blade members104,108are coupled together by means of an articulation or moving mechanism, described in greater detail below.

A handle portion120extends downwardly from the proximal end116of the bottom blade member108. The handle portion120is defined by a shape that permits gripping and use of the speculum100by a single hand of the user. The handle portion120is fully enclosed with the exception of an open lower end128. An enclosed receiving cavity126extends from the open lower end128to a closed upper end132of the handle portion120. A curved light pipe136extending from the closed upper end132of the handle portion120is defined by opposing proximal and distal ends138,140, respectively. The light pipe136extends along a necked portion144of the bottom blade member108defined between the handle portion120and the trough-shaped blade portion118of the bottom blade member108. A coupling and aligning feature is provided at the closed upper end132of the enclosed receiving cavity126, which includes centering fingers148disposed at the closed upper end132that are aligned with a lens152formed at the proximal end138of the light pipe136. As noted, the light pipe136extends in a curved configuration along the necked portion144, as shown inFIG.1(c), and is made from an optically clear light transmissive material, such as an acrylic, that promotes internal reflection.

A known portable illumination assembly160is advanced within the open lower end128of the enclosed receiving cavity126of handle portion120. The illumination assembly160is defined by a housing162having an upper portion164that retains a light source (not shown) adjacent an upper end163and a lower portion166. The lower portion166includes at least one charging contact168that enables a contained battery (not shown) to be recharged. The upper portion164of the housing162is sized to be fitted within the receiving cavity126of the handle portion120through the open lower end128. The upper portion164includes an exterior slide switch165that causes the contained light source to be energized when the illumination assembly160is sufficiently advanced into the enclosed receiving cavity126. The illumination assembly160is further advanced until the upper end163of the housing162is aligned within the centering fingers148and the light source of the illumination assembly160is aligned with the lens152and the proximal end138of the curved light pipe136. Further axial movement is prevented by the lower portion166of the housing162, which is larger in width than the open lower end128of the receiving cavity126. Further details relating to the illumination assembly160are described in U.S. Pat. No. 8,821,395, which is incorporated in its entirety. When the illumination assembly160is powered and the contained light source is energized, such as by the exterior slide switch165, the emitted light is directed through the lens152and is transmitted by internal reflection through the curved light pipe136.

Referring toFIGS.1(a)-1(c), a moving or articulation mechanism is provided to enable the spacing of the top and bottom blade members104,108to be selectively adjusted for purposes of adequately dilating a patient. This moving mechanism includes a lever portion170that is attached to the proximal end116of the top blade member104and a yoke180that is mounted to the proximal end116of the bottom blade member108and the handle portion120. The lever portion170is integral to the top blade member104and extends downwardly relative to the remainder of the top blade member104at a reflexed angle. The lever portion170includes a viewing aperture174, as well as a lower tab176disposed beneath the viewing aperture174, the lower tab176having a slot178.

The yoke180includes a yoke portion182defined by a pair of upwardly extending spaced arms184, the upper ends of the arms184being pivotally attached to the proximal end116of the top blade member104. The yoke180further includes a slide member186downwardly extending from the lower end of the yoke portion182. The slide member186is movably disposed within a vertical slot190formed on a rear facing side of the handle portion120. The slide member186further includes a lower locking member194sized and configured to engage a set of spaced teeth196formed on opposing sides of the vertical slot190, as well as an arcuate pawl arm198between the yoke portion182and the slide member186that extends proximally away from the proximal end116of the speculum100. The arcuate pawl arm198is curved and includes a set of spaced ratchet teeth199that are configured to engage the slot178formed on the lower tab176of the lever portion170. The proximal end116of the lower blade member108is further defined by a recessed portion202that is sized to retain the yoke portion182and permit viewing through the viewing aperture174.

In use, the moving mechanism enables the spacing of the top and bottom blade members104,108to be adjusted. The bottom blade member108is fixed while the position of the top blade member104can be adjusted by engaging the slide member186and elevating or lowering the yoke180against the pivotally attached upper blade member104. The angular position between the top and bottom blade members104,108can be further adjusted by pushing upwardly against the arcuate pawl arm198and varying the position of the arm198relative to the slot178of the lower tab176of the lever portion170.

The illumination assembly160is disposed within the enclosed receiving cavity126of the handle portion120in which the upper end163of the housing162is aligned with the lens152via the centering fingers148. Illumination is directed from the light source (not shown) through the lens152and the proximal end138of the curved light pipe136with the transmitted light being emitted from the distal end140of the curved light pipe136toward the distal end112of the speculum100and the medical target of interest. According to one version, the distal end140of the curved light pipe136is angled to prevent the incidence of back reflection (glare) relative to the user.

With the foregoing background, a vaginal speculum1000made in accordance with an exemplary embodiment and having an integrated illumination assembly1100is shown inFIGS.2-10. First and referring toFIGS.2,4(a) and4(b), the speculum1000is defined by an upper or first blade member1004and a lower or second blade member1008. Each of the upper and lower blade members1004,1008is further defined by a distal end1012having a trough-shaped blade portion1016, as well as an opposing proximal end1018. The speculum1000further includes a handle portion1020downwardly extending from the proximal end1018of the lower blade member1008. The handle portion1020is sized to enable the speculum1000to be held in a single hand of the user/caregiver.

Like the prior described version inFIGS.1(a)-1(c), the vaginal speculum1000includes a moving or articulation mechanism that enables the spacing of the upper and lower blade members1004,1008to be selectively adjusted for purposes of adequately dilating a patient. As shown inFIGS.2,4(a) and4(b), this moving mechanism includes a lever portion1064that is attached to the proximal end1018of the upper blade member1004and a yoke1080mounted to the proximal end1018of the lower blade member1008and the handle portion1020. The lever portion1064extends downwardly relative to the upper blade member1004at a reflexed angle and includes a viewing aperture1068, as well as a lower tab1070disposed beneath the viewing aperture1068, the lower tab1070having a slot1074. Preferably, the lever portion1064is integral with the housing1004. According to this embodiment, the upper and lower blade members1004,1008and the handle portion1020are each made from a lightweight plastic material, which is preferably moldable. Examples of suitable materials that further permit recyclability of the speculum1000include polyethylene, polyamide, and acrylic.

The yoke1080includes a yoke portion1084defined by a pair of upwardly extending spaced arms1085, the upper ends of the extending arms1085being pivotally attached to the proximal end1018of the upper blade member1004. The yoke1080further includes a slide member1086downwardly extending from the lower end of the yoke portion1084. The slide member1086is movably disposed within a vertical slot1090formed on a rear facing side of the handle portion1020. The slide member1086further includes a lower locking member1094sized and configured to engage a set of spaced teeth1096formed on opposing sides of the vertical slot1090. An arcuate pawl arm1098, disposed between the yoke portion1084and the slide member1086, extends proximally away from the proximal end1018of the speculum1000. The arcuate pawl arm1098, which is curved, includes a set of ratchet teeth1099that engage the slot1074formed on the lower tab1070of the lever portion1064.

As in the prior described version ofFIGS.1(a)-1(c), the proximal end1018of the lower blade member1008includes a recessed portion1056that is sized to retain the yoke section1084and permit viewing through the viewing aperture1068. To provide additional stability and as shown inFIGS.2,3,6and8, the recessed portion1056at the proximal end1018of the lower blade member1008is further defined by a pair of channels1060that include guiding features such as shoulders1062, each suitably sized and configured to engage, axially guide and stabilize the upwardly extending arms1085of the yoke portion1084.

In use, the moving mechanism enables the spacing of the upper and lower blade members1004,1008to be selectively adjusted. The lower blade member1008is fixed while the position of the upper blade member1004can be adjusted by engaging the locking member1094and pushing or pulling the slide member1086in the vertical slot1090. Movement of the slide member1086elevates or lowers the yoke portion1082, as guided by the channels1060and shoulders1062, against the pivotally attached upper blade member1004. The angular position between the upper and lower blade members1004,1008can be further adjusted by pushing the arcuate pawl arm1098upwardly relative to the slot1074formed in the lower tab1070of the lever portion1064and shifting the position of the lever portion1064relative to the set of ratchet teeth1099of the arcuate pawl arm1098.

According to this embodiment and as shown inFIGS.3and8, the handle portion1020is defined by an axial cavity1024that is fully enclosed with the exception of the open and opposing upper and lower ends1028,1032. The interior of the enclosed cavity1024can include at least one guide rail. According to this embodiment, a pair of guide rails1036(only one pair being shown) provided on opposing sides of the enclosed cavity1024extends over substantially the entire axial length of the enclosed cavity1024. The number and spacing of these latter features can be suitably varied for use in aligning and retaining an illuminator assembly1100.

As shown inFIGS.5(a) and5(b),6and7, the illumination assembly1100is intended to be fitted within the enclosed cavity1024of the handle portion1020and more specifically into the open upper end1028. The illumination assembly1100is defined by a housing1104(partially shown in these figures), as well an extending curved arm1112that retains a light source. According to this embodiment, the distal end1116,FIG.5(b), of the extending curved arm1112retains an LED (not shown). The extending curved arm1112is shaped and configured to be fitted onto a necked portion1044of the lower blade member1004, which is intermediately disposed between the handle portion1020and the trough-shaped blade section1016of the lower blade member1008. According to this embodiment, at least a portion of the lower blade member1008in the necked portion1044is recessed to receive a distal portion of the extending curved arm1112in order to improve and effectively direct illumination from the retained light source toward the distal end1012of the speculum1000. As shown inFIGS.5(a) and5(b), the positioning of the illumination assembly1100within the speculum1000permits illumination to be directed toward the intended target, but does not interfere with viewing through the rear viewing aperture1068.

Further details of the illumination assembly1100are provided with reference toFIGS.9and10. According to this embodiment, the illumination assembly1100includes the housing1104, which is defined by an upper end1107and an opposing lower end1109. The housing1104further includes an upper flanged section1124having a width that is larger than the width of the open upper end1028of the enclosed receiving cavity1024of the handle portion1020, as shown inFIGS.5and7. The upper end1107of the housing1104supports the extending curved arm1112, which as noted retains an LED (not shown) at a distal end1116of the arm1112. According to this embodiment, the curved arm1112is integral to the housing1104with the housing1104and extending arm1112being formed from a moldable plastic material, such as polyethylene (PETE) or polypropylene. It will be understood, however, that the extending arm1112can be alternatively and separately attached to the upper end1107of the housing1104by suitable techniques such as adhesives, welding, or fasteners.

The housing1104is 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 slots1125integrally provided on an inner surface of the housing1104. An electrical contact1126, configured within the interior of the housing1104, includes a first end arranged to engage the retained batteries, wherein the electrical contact1126extends along the length of the housing1104and into the interior of the curved arm1112with a second end of the electrical contact1126being arranged to engage the distally retained LED (not shown).

The housing1104further includes a cover1120, which according to this embodiment includes an intermediate hinge1122disposed adjacent the upper end1107of the housing1104. Though not shown, the housing1104can further include at least one and preferably two or more frangible tabs or similar features to secure the housing1104within the enclosed cavity1024of the handle portion1020. Removal of the housing1104by pulling the assembly1100from the enclosed cavity1024breaks or otherwise disables the frangible tabs and prevents the illuminator housing1104from being reinstalled into the receiving cavity1024. According to this embodiment, a recessed portion1128,FIG.7, of the upper flanged section1124assists in gripping the illumination assembly1100to enable permanent removal of the illumination assembly1100from the speculum1000.

In use, the illumination assembly1100is disposed within the open upper end1028of the receiving cavity1020of the speculum1000with the extending curved arm1112being supported by the necked portion1044of the lower blade member1008. The upper flanged portion1024prevents the housing1104from being advanced too far into the receiving cavity1020or falling through the cavity1020, the housing1104being guided by the rails1036. The frangible tabs (not shown) secure the illumination assembly1100in place.

Preferably, the housing1104is fully enclosed with the exception of a slot formed at the lower end1109that permits the passage of an extending tab member1150, partially shown inFIG.4(a). The tab member1150is made from an electrically inert material, such as plastic, and includes a distal portion disposed within the interior of the housing1104. More specifically, the distal portion is positioned between the end of the electrical contact1126and the retained battery. The extending tab member1150includes a proximal end, the latter extending outwardly of the open lower end1032of the handle portion1020. When the proximal end is pulled by a user and the tab member1150is removed from the housing1104, engagement is created between the contained batteries and the first end of the electrical contact1126, energizing the supported LED in the extending curved arm1112. Illumination is directed toward the distal end1012of the speculum1000as the recess formed in the necked portion1044of the lower blade member1008assists in maximizing uniform distribution of light emitted by the LED.

Following its intended use the speculum1000, including the illumination assembly1100, 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 assembly1100. According to this described embodiment, there are two (2) techniques available for removing the contained batteries. First, the illumination assembly1100can be removed from the receiving cavity1020by gripping the upper flanged portion1024of the housing1104and extracting the assembly1100from the handle portion1020. In so doing, the frangible tab features are disabled as a result of removing the housing1104from the open upper end1028of the receiving cavity1024. The hinged cover1120can then be opened and the batteries can be removed from the retaining slots1168.

According to a second technique, the batteries can be removed from the housing1104without first removing the illumination assembly1100from the speculum1000. A tool (not shown) can be extended upwardly into the receiving cavity1020through the open lower end1032of the handle portion1020and more specifically into the open slot formed at the lower end1109of the housing1104. The tool is shaped to pry open the hinged cover1120, which drops the batteries which are vertically arranged, through the open lower end1032of the handle portion1020. The speculum1000and illumination assembly1100can then be disposed of for purposes of recycling, without requiring further disassembly.

A further variation of a speculum1200having an integrated illumination assembly1300is shown with reference toFIGS.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 end1032of the handle portion1020is recessed along one wall1208of the handle portion1020to permit finger access to a battery release member1160, the latter extending downwardly from the lower end1109,FIG.10, of the housing1104,FIG.10, of the illumination assembly1300, in addition to the extending tab member1150. According to this embodiment and in lieu of a separate tool, the battery release member1060of the illumination assembly1300can be pulled entirely from the housing1104, and more specifically the lower end1109.

With reference toFIG.13, the battery release member1160according to this embodiment is defined by a single component that includes a battery engagement portion1164at its distal end, which includes a pair of interconnected loops1168. The battery engagement portion1164is sized to fit within the interior of the housing1104and the loops1168are each sized to peripherally cover one of the retained batteries (not shown). An intermediate planar portion1172of the battery release member1160extends to a proximal or user engagement end1176that extends proximate to the recess1208at the lower end of the handle portion1020. According to this described embodiment, the user engagement end1176includes a loop1180that is appropriately sized to permit an extending proximal end of the releasable tab member1150to extend therethrough as well as a guide tab1178. In this version, the extending proximal end of the releasable tab member1150is caused to extend over the guide tab1178at an acute angle relative to the handle portion1020, as shown inFIG.11.

The speculum1200and illumination assembly1300are otherwise no different structurally than the previously described versions1000and1100, respectively. When the illumination assembly1100is mounted within the enclosed cavity1024of the handle portion1020, the user engagement end1176of the battery release member1160is accessible from the open lower end1032of the handle portion1020via the recess1208.

As in the preceding, the releasable tab member1150extends downwardly from the interior of the housing1104such that the proximal end of the tab member1150can be accessed from the open lower end1032of the receiving cavity1024of the handle portion1020, as shown inFIG.11. When the tab portion1150is pulled from the housing1104, the electrical contact1126,FIG.10, is caused to engage the contained batteries and energize the retained LED. The releasable tab member1150is pulled from the speculum1200while the battery release member1160remains in place.

Following examination, the batteries can be removed by accessing the guide tab1178and pulling the user engagement end1176of the battery release member1160. This pulling action withdraws the battery release member1160, as well as the contained batteries, which drop from the lower end1109of the housing1104through the open lower end1032of the handle portion1020. Alternatively and as previously described, the user can separately remove the illumination assembly1300by engaging the recessed portion1128of the upper flanged section1124to pull the illumination assembly1300from the handle portion1020of the speculum1000. Once removed, the hinged cover1120can be opened and the batteries can be removed prior to recycling the illumination assembly1300.

As noted, the herein described illumination assembly (whether1100or1300) 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 toFIGS.14and15, an illumination assembly1100is depicted for use with a laryngoscope1500, the latter instrument being used typically for examining the throat of a patient. The laryngoscope1500according to this embodiment is defined by a handle or handle portion1508that downwardly extends from the proximal end of a single curved blade1514, the latter being configured and shaped for examining the throat of a patient (not shown). The handle1508is shaped and configured to permit one-handed operation of the instrument1500by a practitioner or care provider. The handle1508and blade1514according to this version are made as a unitary component made from a recyclable plastic, such as polyethylene.

The salient features of the illumination assembly1100are as previously described. That is and as partially shown inFIG.14, the illumination assembly1100is defined by a housing1104having a width dimension at the top or upper portion of the housing1104that is wider than a cavity formed in the top or upper portion of the unitary handle1508. A curved arm1112extends outwardly from the housing1104, the latter being shaped and configured to extend partially within the confines of the curved blade1514. At least one LED1190mounted at the distal end of the curved arm1112is electrically coupled to a set of compact batteries (not shown) retained within the housing1104of the illumination assembly1100. According to at least one version, both the illumination assembly1100and the laryngoscope1500can be made from the same recyclable plastic material.

According to this embodiment, the output of the LED1190is optically coupled via a guide1550, the latter being retained within a pocket1558formed in the curved blade1514to direct light to the patient (not shown) being examined. The guide1550according 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 guide1550is configured to effectively direct emitted light from the LED1190to the distal end of the blade1514and subsequently the throat of the patient.

FIGS.14and15illustrates a laryngoscope1500having an adult (large) laryngoscope blade1514. A similar version, shown inFIGS.16and17, depicts a laryngoscope1600having a smaller adult laryngoscope blade1614, which is inherently narrower dimensionally. In this latter version and in lieu of a conical guide, the LED1190of the contained illumination assembly1100is optically coupled with a guide in the form of a prism1650. The prism1650is made from a light transmissive material that is configured and positioned within a pocket or cavity1658formed in the blade1614of the laryngoscope1600in order to effectively direct emitted light from the contained illumination assembly1100, and more specifically the LED1190.

In each of the versions depicted inFIGS.14-17and as in the prior embodiments described above, the illumination assembly1100(or1300or variants) is preferably configured for energization of the LED1190using an extending tab member that is accessible via an open end of the handle1508,1608of the laryngoscope1500,1600. Removal of the contained batteries can be realized using a tool (not shown) configured to open a hinged cover of the housing1104or 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 instrument1500,1600. Alternatively, the illumination assembly1100can be separately removed from the handle of the laryngoscope and the batteries can be removed by accessing the hinged cover of the housing1104.

According to this version, the instrument handle1508,1608can further or alternatively include a frangible side cover1520,1620to permit removal of the illumination assembly1100in order to remove the retained batteries from the housing1104. Preferably, removal of the side cover1520,1620limits the structural capability of the instrument handle1508,1608for continued use as an instrument handle, thereby preventing any subsequent reinstallation of the illumination assembly1100. In each of the above embodiments, the batteries can be removed separately prior to recycling of the instrument1500,1600, including the illumination assembly1100.

FIG.18depicts the further use of an illumination assembly1100in conjunction with a number of disparate recyclable medical devices. Though the assembly1100is shown here, it will be understood that other variants can be utilized for this purpose. As shown, the illumination assembly1100includes a housing1108, as well as a curved arm1112extending from an upper end of the housing1108that retains an LED1190at its distal end, the LED1190being coupled electrically to a set of batteries1196that are retained in the housing1108. The housing1108can include a hinged cover, as well as a lower or bottom extending tab portion or member1150that can be used as a switch to energize the LED1190when pulled by a user. A battery release member1160, as described above, is also provided to enable the contained batteries1196to be withdrawn from the housing1104in a manner, as previously described. As shown, the illumination assembly1100can be integrated within a vaginal speculum1800, a laryngoscope1830, in addition to a sigmoidscope1840, and an anoscope1860, 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

100vaginal speculum104first or top blade member108second or bottom blade member112distal end, blade members116proximal end, blade members118trough-shaped blade portion120handle portion126enclosed receiving cavity128open lower end132closed upper end136curved light pipe138proximal end, light pipe140distal end, light pipe144necked portion148centering fingers152lens160illuminator, portable162housing, illuminator163upper end164upper portion, illuminator165slide switch, exterior166lower portion, illuminator168charging contact, battery170lever portion174viewing aperture176lower tab178slot, tab180yoke182yoke portion184upwardly extending spaced arms186slide member190vertical slot194lower locking member196spaced teeth198arcuate pawl arm199teeth, ratchet202recessed portion1000speculum1004first or upper blade member1008second or lower blade member1012distal end1016trough-shaped blade portion1018proximal end1020handle portion1024axial cavity, enclosed1028open upper end1032open lower end1036guide rails1044necked portion1056recessed portion1060channels1062guiding features1064lever portion1068viewing aperture1070lower tab1074slot1080yoke1084yoke portion1085upwardly extending arms1086slide member1090vertical slot1094lower locking member1096teeth, spaced1098arcuate pawl arm1099ratchet teeth1100illuminator assembly1104housing1107upper end, housing1109lower end, housing1112curved arm1116distal end1120cover1122hinge, intermediate1124upper flanged section, housing1125retaining peripheral slots1126electrical contact1128recessed portion1150releasable tab portion1160battery release member1164battery engagement or support portion1168loops, interconnected1172outwardly extending portion1176user engagement end1178guide tab1180loop1190LED1196batteries1200speculum1208access slot1300illumination assembly1500laryngoscope1508handle1514blade1520side cover1550guide1558pocket1600laryngoscope1608handle1614blade1620side cover1650prism1658pocket or cavity1800vaginal speculum1830laryngoscope1840sigmoidoscope1860anoscope

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.