Protective sheath for illumination assembly of a disposable vaginal speculum

FIELD OF THE INVENTION

[0001] 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

[0002] 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.

[0003] 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.

[0004] 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

[0005] It is therefore a primary object of the present invention to overcome the above-noted deficiencies of the prior art.

[0006] It is another primary object of the present invention to better protect the illumination assembly of a disposable vaginal speculum system during examination.

[0007] 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.

[0008] Therefore and according to a preferred aspect of the present invention, there is provided a vaginal speculum assembly comprising:

[0009] a disposable speculum having a handle;

[0010] 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;

[0011] a protective sheath;

[0012] a support member attachable to the handle of said speculum onto which said protective sheath is mounted in a stored condition;

[0013] 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.

[0014] 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.

[0015] 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.

[0016] 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.

[0017] 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.

[0018] 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:

[0019] 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;

[0020] attaching the illumination assembly to said disposable speculum;

[0021] deploying said protective sheath from said stored condition prior to use of said speculum so as to cover said illumination assembly.

[0022] 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.

[0023] 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.

[0024] 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.

[0025] 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.

[0026] 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

P-0027[0027]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;

P-0028[0028]FIG. 2 is a side elevational view of the vaginal speculum depicting the interconnection of the protective sheath of FIG. 1;

P-0029[0029]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;

P-0030[0030]FIG. 3 is a side view of the sheath supporting member of FIGS. 1-2A;

P-0031[0031]FIG. 4 is the side view of the sheath supporting member of FIG. 3 with a sheath attached thereto; and

P-0032[0032]FIGS. 5-9 are sequential in-use depictions of the protective sheath relative to the disposable vaginal speculum assembly.

DETAILED DESCRIPTION

P-0033[0033] 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.

P-0034[0034] Referring to FIG. 1, there is shown a disposable vaginal speculum system <b>10</b> in accordance with the present invention. The herein described speculum system <b>10</b> includes a disposable vaginal speculum <b>20</b>, an illumination assembly <b>24</b>, and a protective sheath assembly <b>100</b>.

P-0035[0035] More particularly and as shown in FIGS. 1, 2 and <b>2</b>A, the disposable vaginal speculum <b>20</b> includes three main interconnected components; namely, a fixed blade member <b>38</b>, a movable blade member <b>42</b> and a slide member <b>46</b>. Each of the fixed blade member <b>38</b> and the movable blade member <b>42</b> are preferably made from a clear, inflexible plastic material, such as acrylic or polystyrene, in which the fixed blade member <b>38</b> includes a trough shaped blade and a hollow leg <b>50</b> that forms a handle for the user of the speculum <b>20</b>. The slide member <b>46</b> is preferably made from a resilient plastic material, such as polypropylene, includes a forked upper end <b>54</b> that receives the movable blade member <b>42</b> which is pivotally attached thereto, including a lever portion <b>58</b> that is adjustably attached via a ratchet mechanism <b>62</b> provided on the top of the slide member <b>46</b>. In addition, the slide member <b>46</b> includes a lower tongue <b>66</b> having ratchet teeth that engage with corresponding teeth provided on the rear side of the hollow leg <b>50</b> of the fixed blade member <b>38</b> of the disposable vaginal speculum <b>20</b> to provide further adjustment therebetween.

P-0036[0036] The hollow leg <b>50</b> of the fixed blade member <b>38</b> of the disposable vaginal speculum <b>20</b> includes a pair of parallel slots <b>70</b>, <b>72</b>. Slot <b>70</b> is sized for receiving a portion of the illuminator assembly <b>24</b> as well as aligning the inserted illuminator assembly portion relative to an interior curved light bar <b>74</b>, shown in FIG. 2A, that receives the light from a miniature incandescent lamp (not shown) contained in the inserted portion of the illuminator assembly <b>24</b> and directs it along a longitudinal axis of the fixed blade member <b>38</b>. Additional details concerning the components and overall operation of the herein described disposable vaginal speculum <b>20</b> can be found in U.S. Pat. No. 3,716,047, the entire contents of which are herein incorporated by reference.

P-0037[0037] Still referring in general to FIG. 1, the illumination assembly <b>24</b> includes a miniature light source, such as a miniature incandescent halogen lamp (not shown), that is disposed within a lamp housing <b>82</b> that is threaded into the distal end of an enclosure <b>86</b>. The enclosure <b>86</b> is that portion of the illumination assembly <b>24</b> that is placed into the slot <b>70</b> of the disposable vaginal speculum <b>20</b>. The enclosure <b>86</b> includes a gripping portion/strain relief <b>96</b> at a proximal end thereof to permit a user to insert or remove the enclosure of the illumination assembly <b>24</b> from the interior of the hollow end <b>50</b> of the disposable vaginal speculum <b>20</b>. A cord <b>87</b> extends from the gripping portion/strain relief <b>96</b> of the enclosure <b>86</b>, the cord containing a number of electrical conductors (not shown) connected to electrical contacts provided in the enclosure.

P-0038[0038] An in-line illumination switch assembly <b>85</b> is attached to a proximal end of the cord <b>87</b>, the in-line switch assembly including a cover housing <b>89</b> having an integral switch <b>91</b> to permit selective energization of the lamp. The cover housing <b>89</b> is tapered, preferably, and includes strain reliefs on opposite sides thereof, interconnecting the enclosure <b>86</b> and a power supply, such as a transformer <b>98</b>, in which a second cord <b>93</b> containing electrical conductors extends from the in-line switch assembly to a plug <b>90</b> that is fittable with a mating plug <b>94</b> that is tethered by a third cord <b>95</b> to the transformer <b>98</b> in order to selectively supply electrical power to the enclosed halogen lamp.

P-0039[0039] The lamp housing <b>82</b> includes an electrical contact (not shown) at its proximal end that engages corresponding electrical contacts inside the enclosure <b>86</b>, the housing including an internal <b>0</b>-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 <b>82</b> and enclosure <b>86</b> 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 <b>86</b> can now undergo sterilization procedures.

P-0040[0040] Referring to FIGS. 1, 2A, <b>3</b> and <b>4</b>, the protective sheath assembly <b>100</b> includes a sheath supporting member <b>104</b> defined by a short hollow cylindrical tubular housing <b>102</b> having a distal end <b>108</b> and a proximal opening <b>112</b>. The distal or connecting end <b>108</b> of the sheath supporting member <b>104</b> includes an outwardly extending pawl <b>116</b> adjacent a rectangular shaped insertion portion <b>120</b> having a distal opening <b>122</b>, the insertion portion being sized for engaging the slot <b>70</b> formed in the proximal end of the hollow leg <b>50</b> of the speculum <b>20</b>. The rectangular opening <b>122</b> is also sized to receive the molded body of the enclosure <b>86</b> of the illumination assembly <b>24</b>, permitting the enclosure to pass therethrough into the slot <b>70</b> of the disposable vaginal speculum <b>20</b>. The extending pawl <b>116</b> includes an engagement tooth <b>128</b> at its distalmost end and a thickened base portion <b>129</b> for positively engaging with the interior of the rear wall of the hollow leg <b>50</b> of the speculum <b>20</b>, the tooth engagement being shown in FIG. 2A.

P-0041[0041] The distal end <b>108</b> of the sheath supporting member <b>104</b> further includes an annular receiving portion <b>134</b> having a diameter that is larger than that of the tubular housing portion <b>102</b>, the receiving portion including a concave supporting surface <b>138</b>.

P-0042[0042] The exterior or distal facing side of the annular receiving portion <b>134</b> includes a plurality of support tabs <b>148</b> used as a fastening and release means for a stored protective sheath <b>144</b> in conjunction with a plurality of spaced corresponding notches <b>156</b> provided at the proximal end of the tubular support portion <b>102</b> of the sheath supporting member <b>104</b>. As detailed below, an elastic band <b>152</b> or other restraining means is looped over the support tabs <b>148</b> and notches <b>156</b> to provide support when placed along protective sheath <b>144</b>, holding compressing and retaining the sheath in place

P-0043[0043] Referring to FIGS. 1, 2, <b>4</b> and <b>5</b>, the protective sheath <b>144</b> 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 <b>24</b>, including the cords <b>87</b>, <b>93</b> and the in-line switch assembly <b>85</b>. Preferably, the protective sheath <b>144</b> is made from polyethylene, though other suitable materials can be used, transparent or otherwise. It is not required, however, that the protective sheath <b>144</b> necessarily be constructed from a biocompatible material. In terms of preassembly, one end of the sheath <b>144</b> is fixedly attached by adhesive tape or other means to the sheath supporting member <b>104</b> and more particularly at the proximal side of the annular supporting portion <b>134</b>. In terms of compressing into the stored condition on the sheath supporting member <b>104</b>, the protective sheath <b>144</b> is initially extended and then compressed to be formed into its stored condition such that release of the elastic band <b>152</b> from the retaining means of the sheath supporting member <b>104</b> will permit the sheath to drop over the illumination assembly <b>24</b>, including the in-line switch assembly <b>85</b>, as described in greater detail below. Finally, the opposite end of the protective sheath <b>144</b> forms an protruding tail <b>175</b> extending from remainder of the compressed sheath, shown only in FIGS. 1 and 2, 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.

P-0044[0044] Referring now to FIGS. 5-9, the operation of the herein described invention is summarized in use.

P-0045[0045] First and referring to FIGS. 2A and 5, the sheath supporting member <b>104</b> is attached to the proximal end of the fixed blade member <b>38</b> of the disposable vaginal speculum <b>20</b> with the protective sheath <b>144</b> 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 <b>104</b> is attached to the disposable vaginal speculum <b>20</b> by properly aligning the extending pawl <b>116</b> at the distal end <b>108</b>, FIG. 4, thereof with slot <b>72</b> of the hollow leg <b>50</b> of the speculum <b>20</b> and the insertion portion <b>120</b>, FIG. 2A, with slot <b>70</b> and then pushing the supporting member into place according to arrow <b>160</b>, until the engagement tooth <b>128</b> positively engages with the interior of the rear wall of the hollow leg <b>50</b>

P-0046[0046] Referring briefly to FIG. 4, an O-ring <b>175</b> is also preferably installed onto the exterior of the insertion portion <b>120</b>. This O-ring <b>175</b> functions to take up slack for mold cavity variability in the manufacture of the sheath supporting member <b>104</b> and further provides additional protection from fluid ingress.

P-0047[0047] Next and referring to FIG. 6, the enclosure <b>86</b> of the illumination assembly <b>24</b> is then inserted as held by enclosure <b>86</b> through the proximal opening <b>112</b> and the rectangular opening <b>122</b> defined in the distal insertion portion <b>120</b>, FIG. 2A, of the assembled sheath supporting member <b>104</b> and into the slot <b>70</b>, FIG. 2A, of the hollow leg <b>50</b> of the disposable vaginal speculum <b>20</b>, sized to retain the enclosure <b>86</b> in a manner that is conventionally known, as indicated by arrow <b>162</b>.

P-0048[0048] Next and referring to FIGS. 7 and 8, the protective sheath <b>144</b> is deployed by detaching the elastic band <b>152</b> from the supporting tabs <b>148</b> and notches <b>156</b>, arrows <b>164</b>, in order to release the sheath from its stored compressed condition on the sheath supporting member <b>104</b>. Following the release of the elastic band, the tail <b>174</b>, FIG. 1, of the deployed protective sheath <b>144</b> is then pulled downwardly so as to cover the depending cord and the in-line switch portions of the illumination assembly <b>24</b>, as shown by arrows <b>168</b> in FIG. 8.

P-0049[0049] The protective sheath <b>144</b> is shaped so as to permit the sheath to be easily pulled over the illumination assembly, including the in-line switch assembly <b>85</b>, as shown by arrows <b>168</b>. The physician can then use the use the system <b>10</b> to conduct an examination of the patient in the conventional manner. The illumination assembly <b>24</b> is energized by activating switch <b>91</b> of the in-line switch assembly <b>85</b>, which can easily be activated through the protective sheath <b>144</b> while the sheath covers this portion of the assembly.

P-0050[0050] Following examination and referring to FIG. 9, the illumination assembly <b>24</b> is turned off and the transformer <b>98</b> is disconnected from the remainder of the stem <b>10</b>. The remainder of the assembly can then be placed over a refuse container <b>176</b>, holding the extending proximal end of the cord <b>93</b> of the illumination assembly <b>24</b> and pulling downwardly, the illumination assembly can be released from the disposable speculum <b>20</b> such that the speculum and the attached protective sheath <b>144</b> can be easily discarded, shown by arrow <b>172</b>.

Parts List for FIGS.

1

-

9

P-0051[0051]<b>10</b> disposable vaginal speculum system

P-0052[0052]<b>20</b> disposable vaginal speculum

P-0053[0053]<b>24</b> illumination assembly

P-0054[0054]<b>38</b> fixed blade member

P-0055[0055]<b>42</b> movable blade member

P-0056[0056]<b>46</b> slide member

P-0057[0057]<b>50</b> hollow leg

P-0058[0058]<b>54</b> forked upper end

P-0059[0059]<b>58</b> lever portion

P-0060[0060]<b>62</b> ratchet mechanism

P-0061[0061]<b>66</b> lower tongue

P-0062[0062]<b>70</b> slot

P-0063[0063]<b>72</b> slot

P-0064[0064]<b>74</b> interior curved light bar

P-0065[0065]<b>82</b> lamp housing

P-0066[0066]<b>85</b> in-line illumination switch assembly

P-0067[0067]<b>86</b> enclosure

P-0068[0068]<b>87</b> cord

P-0069[0069]<b>89</b> cover housing

P-0070[0070]<b>90</b> plug

P-0071[0071]<b>91</b> switch

P-0072[0072]<b>93</b> cord

P-0073[0073]<b>94</b> plug

P-0074[0074]<b>95</b> cord

P-0075[0075]<b>96</b> gripping portion/strain relief

P-0076[0076]<b>98</b> transformer

P-0077[0077]<b>100</b> protective sheath assembly

P-0078[0078]<b>102</b> tubular supporting portion

P-0079[0079]<b>104</b> sheath supporting member

P-0080[0080]<b>108</b> open end-distal

P-0081[0081]<b>112</b> open end-proximal

P-0082[0082]<b>116</b> pawl

P-0083[0083]<b>120</b> opening

P-0084[0084]<b>128</b> engagement tooth

P-0085[0085]<b>129</b> base portion

P-0086[0086]<b>134</b> annular receiving portion

P-0087[0087]<b>138</b> supporting surface

P-0088[0088]<b>144</b> protective sheath

P-0089[0089]<b>148</b> support tabs

P-0090[0090]<b>152</b> elastic band

P-0091[0091]<b>166</b> notches

P-0092[0092]<b>160</b> arrow

P-0093[0093]<b>162</b> arrow

P-0094[0094]<b>178</b> arrow

P-0095[0095]<b>172</b> arrow

P-0096[0096]<b>174</b> tail

P-0097[0097]<b>175</b> O-ring

P-0098[0098]<b>176</b> refuse container

P-0099[0099] 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.