|Publication number||US3373736 A|
|Publication date||Mar 19, 1968|
|Filing date||Mar 22, 1965|
|Priority date||Mar 22, 1965|
|Publication number||US 3373736 A, US 3373736A, US-A-3373736, US3373736 A, US3373736A|
|Inventors||Ferro William Frank, Fiore John Michael|
|Original Assignee||Smith Kline French Lab|
|Export Citation||BiBTeX, EndNote, RefMan|
|Patent Citations (7), Referenced by (25), Classifications (7), Legal Events (1)|
|External Links: USPTO, USPTO Assignment, Espacenet|
March 19, 1968 J. M. FIORE ETAL SIGMOIDOSCOPE AND ILLUMINATING MEANS THEREFGR 2 Sheets-Sheet 1 Filed March 22, 1965 SIGMOIDOSCOPE AND ILLUMINATING MEANS THEREFOR 2 Sheets-Sheet 2 Filed March 22, 1965 0 M $0 O R E TE NW mm m V T IF. mp i Mm l- M Q ww Q Y B \J 8 finite 5 Claims. (Cl. 128-6) ABSTRACT OF THE DISCLOSURE An illumination unit for use with a speculum device consisting of a housing means, releasably secured to the proximable end of the speculum, elongated support means releasably secured to the housing means, illuminable means secured to the free end of the support means, and disposable contamination means surrounding both the support and illuminable means.
This application is a continuation in part of our copending application Ser. No. 339,479, filed Jan. 22, 1964, now abandoned.
This invention relates to a single use disposable sigmoidoscope and illumination means therefor, and more particularly to a contamination protected non-disposable light source means positioned internally and at the distal end of a disposable sigmoidoscope.
In the use of medical speculum devices generally a light source is desirable to increase the accuracy of more precise types of diagnostic examinations, and also to facilitate various treatment processes carried on through the device. Ordinarily such a light source may be one which is ordinarily separate from the instrument, or one which is attached thereto, and arranged in either instance to have light directed into or through the speculum. These and other similar arrangements suffice for short-length speculum devices where relatively low lighting power of the light source is sufficient. However, in the longer speculum instruments such as a sigmoidoscope, where the effective length may be on the order of 25 centimeters or more, and where the instrument is of necessity an enclosing cylinder, more lighting power is necessary because of distance involved and the area to be examined. Because of these notable requirements, it is usual practice in sigmoidoscopes for the light source to be placed inside the instrument and at the distal end thereof. In this position, however, the light source is subject to contamination from contact with the patient directly or indirectly so that without means for maintaining the light source in a sterile or sanitary condition immediate reuse for other patients is prohibited. The high desirable disposability of the sigmoidoscope is therefore limited by being combined and employed with a lighting means which is not disposable.
Accordingly, it is an object of this invention to provide an improved disposable speculum and illumination means.
It is another object of this invention to provide an improved disposable sigmoidoscope with self-contained internal illumination means externally releasably secured thereto.
It is a further object of this invention to provide means for continuously maintaining internal illumination means in a disposable sigmoidoscope in a sanitary or sterile condition.
It is another object of this invention to provide an externally attached, internally positioned, illumination means in the form of an electrical lamp adjacent the distal end of a disposable sigmoidoscope and prevented from direct or indirect contact with the patient.
It is still another object of this invention to provide States Patent lighting means for disposable sigmoidoscope having the lighted portion enclosed in a sanitary casing and positioned internally of the sigmoidoscope at the distal end thereof.
Briefly described, this invention includes, in one preferred form, the combination of a readily and economically disposable sigmoidoscope, together with an internal light source which is protected from contamination. A rechargeable battery unit is releasably secured externally at the proximal end of the sigmoidoscope, and a support rod projects into the sigmoidoscope terminating adjacent the distal end thereof. An electrical lamp is positioned at the end of the support rod to provide a light source closely adjacent the area to be examined. A removable transparent sleeve or cover about the support rod maintains the support rod and lamp assembly free from con- 'tamination during the use of the sigmoidoscope.
In another embodiment, all of the materials of construction and physical features are the same, excepting the effective length of the light support rod, which is substantially shortened to about 15 cm. to adapt the instrument to examination of the middle portion of the sigmoid colon, referred to in the medical art as a proctoscopic examination.
In a third embodiment, the effective length of the rod support of the rectal speculum of this invention is reduced to about 8 cm., for what is termed an anoscopic examination. Thus, variation of the effective length of this instrument is within the scope of the invention to accomplish the particular species of rectal examination intended by the practitioner.
It is also contemplated as within the scope of this invention to mate speculums and support rod of dissimilar lengths. For example, a support rod of about 7 cm. may be employed with a sigmoidoscope of about 25 cm. in effective length. This is to accommodate those medical practitioners who prefer a proximal light source rather than a distal one when conducting a sigmoidoscopic ex- "amination.
This invention will be better understood when taken in connection with the following description and the drawings in which:
FIG. 1 is a cross-sectional assembly view of one preferred embodiment of this invention.
FIG. 2 is an exploded view of the assembly of FIG. 1 denoting the interfitting relationship of the illustrated parts.
FIG. 3 is a cross-sectional assembly view of another preferred embodiment of the lamp unit of this invention; an
FIG. 4 is an exploded view of embodiment of FIG. 3.
Referring now to the drawing, wherein like parts have been designated with like reference numerals, and to FIG. 1, in particular, there is illustrated one preferred configuration of a sigmoidoscope assembly 10 in accordance with the teachings of the invention. sigmoidoscope assembly 10 comprises a three part arrangement including a sigmoidoscope 11, a light unit 12 and an eye piece 13. sigmoidoscope 11 in one preferred form of this invention is a single use disposable sigmoidoscope similar to the sigmoidoscope disclosed in copending application Ser. No. 322,597, Fiore et al., filed Nov. 12, 1963, now abandoned. In the mentioned copending application a similar sigmoidoscope is described which is manufactured or produced by a molding process from a readily and economically disposable material including such materials as produced from fibers, therrno-plastics, etc. Accordingly, scope assembly 10 may be fabricated from plastics having the aforementioned features, such as economy of material, durability, sterilizability, and suificient rigidity without brittleness. We have found that the thermoplastics known the major parts of the as the linear polyolefins, which can be readily injection molded, give disposable instrument components having the right combination of physical properties.
Thermoplastic resins, particularly the polyolefins, possess most of the properties desired in the material for the speculum of this invention, because of their moldability, flexibility, lack of toxicity, and general good resistance to deterioration by environment conditions and aging. While we can use any-solid linear polyolefin successfully for the practice of this invention, we prefer to use those linear polyolefins, and particularly linear polyethylene, having a density of 0.940 to 0.980, which in the molded product contributes to a lack of sharp edges, a feature which is important to the present invention. Linear polyolefins particularly suitable for injection and/ or extrusion molding in accordance with this invention are the high density polyolefins made, for example, in accordance with the Hogan and Banks US Patent No. 2,825,712, issued Mar. 4, 1958. This family of polyolefins are of higher density than the original high pressure polyolefins. To illustrate, polyethylene of this type has a density of 0.960 to 0.980, as compared to higher pressure polyethylenes of about 0.920. Even when copolymerized with minor amounts of other olefins, such as l-butene, the density of the copolymer is above 0.940. ALATHON 7050, a linear polyethylene having dielectric properties, is a typically suitable linear polyethylene for the practice of this invention. The aforementioned application also describes a single use" device wherein the sigmoidoscope is completely disposable, i.e. not intended for any further use, after a single use. The disclosure and teachings of the mentioned copending application is included by reference herein.
In the present invention, the disposable sigmoidoscope 11 includes, for example, linear polyolefins, such as linear polyethylene or polypropylene barrel or hollow cylinder portion 14 which is provided during the forming or molding process with a pair of ridges or shoulders 15 and 16. Ridges 15 and 16 are adapted to position and retain therebetween a suitable hand guard 17. Hand guard 17, which may be of the same material as cylinder 14, is assembled on cylinder 14 in the position illustrated by being forced over ridge 15. Because of the pliable nature of the linear polyolefin material of guard 17 and cylinder 14, the described force fitting is not detrimental to the device, and hand guard 17 is releasably retained in the illustrated position. Cylinder 14 is also provided with a nipple outlet 18 between the hand guard 17 and the proximal open end 19 to introduce or withdraw air from the interior of cylinder 14 during operative practice of this invention. Cylinder 14 is also fitted with a slidably removable bturator assembly (not shown) which projects from open distal end 20 as is the usual practice in the art. The obturator assembly facilitates insertion of the cylinder 14 into a body orifice and is withdrawn prior to the insertion of light assembly 12 into cylinder 14.
Light unit 12 as illustrated in its operative position in FIG. 1 includes a housing 21 adapted to contain an electrical power source, such as a battery or rechargeable element 22. Battery element 22 in one preferred form of this invention is a rechargeable nickel cadmium cell as is well known in the art. Attached to housing 21 is an elongated rod-like support 23 which extends into cylinder 14 along and adjacent the wall thereof terminating near the distal end 20. At the end of rod 23 there is positioned a very small prefocused electrical lamp means 24 as the light source for the sigmoidoscope 10. A suitable miniature lamp is one rated at 2.5 volts, and 300 milliamperes, such as the General Electric 1861D. Lamp means 24 is suitably electrically connected to battery element 22 by one of several means, for example, by having suitable conductors extending through rod 23 or in a preferred form of this invention, by a single electrical conductor extending through and insulated from rod 23, where a metal rod 23 is employed as an additional electrical conductor. Numerous other well known electrical connections may be suitably employed without departing from the scope of this invention. Rod 23 may be of a telescopic or otherwise adjustable nature, or manufactured in various lengths, so that the distal position of lamp means 23 in cylinder 14 may be varied, or so that light unit 12 may be suitably employed with various other similar devices having shorter or longer similar cylinders such as cylinder 14.
In one embodiment of this invention rod unit 23 is releasably secured to projection 25 of housing 21, with rod 23 fitting within an aperture 26 in projection 25. The insertion of rod 23 into projection 25 also serves to provide the proper electrical connection from electrical conducting means in rod 23 to a suitable electrical conductor 27 leading to battery 22. While the insertion of rod 23 into aperture 24 may be provided through various suitable known bayonet or prong means which close a defined electric circuit and effectively securely lock the elements in place, it is contemplated that other electrical switching means such as on off switches may be employed which are operable by the practitioner as desired, and which do not involve assembling of parts.
The rod 23, together with lamp means 24 in the position as illustrated, is exposed during use to considerable contamination by the patient, and would accordingly need to be sanitized or sterilized before each succeeding use. Otherwise transmission of various bacterial or virus infections may take place from one patient to another or from the patient to the medical practitioner or to associated coworkers. It is necessary that the exposed rod 23 and lamp means 24 be maintained in a sterile or sanitized condition such that it may be reused without necessity of undesirable expensive and time consuming cleansing procedures. Otherwise the numerous and highly desirable advantages which flow from the use of a disposable sigmoidoscope are limited by a light source, when so employed, which is either not disposable in the same sense as the scope is disposable, or requires special cleansing which would delay immediate reuse for the same type of examination or with other instruments or devices as mentioned.
Accordingly an important feature of this invention is the use of a disposable closed end sleeve element 28 which is positioned to contain rod 23 therein and to prevent any contamination of rod 23 or light unit 12. Sleeve 28 may be produced from various materials and combinations of materials, which may be rigid, semirigid, or flexibly soft. The only critical requirements of sleeve 28 is that the material be relatively impervious to fiuids for a reasonable time or otherwise prevent transmittal of virus or bacteria therethrough. It is also necessary that the closed end 29 be transparent or translucent to transmit light from lamp 24 therethrough without substantial diminishing of intensity. Most clear plastics meet these requirements and are suitable sleeve 28 materials. By way of example, such materials may include pliofilm, polyethylene, cellophane, etc. In one preferred form of this invention sleeve-s 28 are of a clear thin polyethylene film and from about A; to inch inside diameter.
The open end of cylindrical sleeve 28 is provided with an axial slit to form a pair of extending flaps 30 and 31. In the operative position illustrated in FIG. 1, one of these flaps 30 from the underside of rod 23 extends into the space between hand guard 17 and housing 21, and the other flap 31 extends over projection 25 and between housing 21 and eye piece 13 externally of the instrument. These flaps serve a two-fold purpose. They provide ready means for the practitioner to grasp to remove sleeve 28 from rod 23, and they provide further protection to projection 25 and casing 21. One method employed to produce a satisfactory sleeve 28 includes providing a long narrow rectangular strip of clear thin plastic and folding it in half transversely. The longitudinal edges are then heat sealed leaving a suflicient length at the open end unsealed to provide flaps and 31.
A further important feature of this invention is the light unit 12 in combination with the sleeve 28 and together in combination with sigmoidoscope .10. Light unit 12 is releasably secured externally of the sigmoidoscope 11 while rod 23 extends internally therein. The releasably securing means thus requires cooperative relationship of specifically provided means on the sigmoidoscope 11 and on the housing 21.
Referring now to FIG. 2, the securing means associated with housing 21 includes a pair of encircling arm members 32 and 33, extending from or being a part of housing 21, which define a central opening 34 of sufficient size to slide over the proximal end 19 of sigmoidoscope 10. At the same time the ends of arm members 32 and 33 are spaced apart to define an open slot 35 which is adapted to slide by and contain nipple 18 on sigmoidoscopel l. In order to provide the positioning of housing 21 adjacent hand guard 17, a longitudinal slot 36 is provided in the wall of the distal end 19 of sigmoidoscope 11. This slot 36 is dimensioned to slidably receive projection 25 on housing 21. The combination of slot 36 containing projection 25 secures and positions lighting unit 12 and prevents relative rotation between the unit 12 and sig moidoscope 11. At the same time the fitting of nipple 18 in slot 35 adds stiffness to this feature and permits ready rotation of the sigmoidoscope by means of housing 21.
Where necessary or where desirable, an eye piece 13 may be fitted to the open proximal end 19 of sigmoidoscope 11. An eye piece is generally necessary when air is to be introduced into cylinder 14 through nipple 18, or where object magnification is desired. Such an eye piece may be economically produced from various plastics as those mentioned and accordingly be of a single use disposable variety.
In FIGS. 3 and 4, in one preferred form of this invention, eye piece 13 includes a one piece molded plastic flared housing 37 containing an integral lens 38. Lens 38 is not required to have a high degree of magnification, if indeed any magnification, and therefore need not be optically perfect. Such plastics as Plexiglass or Lucite acrylic resins may be gainfully employed for eye piece 13. In addition, since only a transparent lens is basically required, no criticality attaches to the material or structure of housing 37. Thus, housing 37 may be of one material as a metal, non-metal, organic or inorganic, and the lens of a different transparent material sealed in place.
In order to secure eye piece 13- to sigmoidoscope 11, eye piece 13 is provided with a pair of diametrically opposed inner projections 39 and 40 which may be of plastic molded integrally with housing 37 or of a metal inserted in the plastic. Suitable I slots 41 and 42 are provided in the distal end 19 of sigmoidoscope 11 so that eye piece 13 may be fitted on the end 19 of sigmoidoscope 11 with projections 39 and 40 fitting into I slots 41 and 42. By moving eye piece 13 axially on distal end 19 for a short distance and then rotating eye piece 13 clockwise, eye piece 13 is secured to sigmoidoscope 10 through the interfitting relationship of projections 39 and 40 and slots 41 and 42.
In another embodiment, the physical features are substantially the same. The principal differences in this embodiment are changes in the position of outlet 18a, the form of housing 21a which is the air introduction means, and the manner of releasable attachment of cylinder 14a, lamp unit 12a, and eyepiece 13a as shown in FIGS. 3 and 4.
Firstly, the arm members 32 and 33 of the first embodiment have been made continuous, as now shown as hollow cylindrical member 32a. The nipple 18a is secured to member 32a and communicates with the central opening or chamber 34 therein. A circular channel 46 is provided in the proximal face of 32a to accommodate a resilient O-ring 47. A similar channel and O-ring (not seen) are provided in the hidden distal face of member 32a. In this manner, a hermetic seal can be maintained within chamber 34a when supplied with air through pipe 18a by the sealing of the O-rings against abutting ends 16a and 37 Other locations for the O-ring seals are Within the scope of this invention. For example, a circular channel (not shown) may be provided in each of the abutting ends, 19 of tube 14a, and in face 37 of eye piece 13, with resilient O-rings being disposed respectively therein, to provide the desired sealing of chamber 34.
The proximal end of cylinder 14a has been modified as shown, to accommodate the modified structure of member 32a. A I-shaped recess 41a is seen in the viewable face of cylinder 14a, and a diametrically opposing recess 42a is provided in the hidden face of 14a. A transverse recess 48 is provided in the outer and upper face of tube 14, near its proximal end. Within recess 48, is perforation 49, which permits communication to the inside of tube 14 for the introduction of air pressure. Longitudinal slot 36 is retained to slidably key on projection 25. Eye piece 13a has been modified as to its threading and the inclusion of internal projection 40a to detachably engage the slot 42a on tube 14. Another projection (not shown) engages slot 41a.
When the scope has been positioned within the body cavity, as will be described, the components will then be cooperatively attached, as shown in FIG. 3, to conduct the examination. At its distal end, projection 25 is provided with a J-slot 51 that detachably secures pin 52 of rod 23 in fixed relation.
It will be observed that slot 48 has been carefully positioned so as to overlap the inlet end 18i of pipe 18a. In this manner, the introduction of air through the pipe will be directed only through the matched passages to the inside of tube 14, as desired. Where dilation of the body cavity is indicated, an ancillary source of air pressure (not shown), perhaps only a squeeze bulb, is detachably secured to pipe 18. Slots 41a and 42a may be tapered to provide a camming action to insure tightness of seal of eye piece.
The embodiment of this invention as illustrated in FIG. 1 is shown in its operative completeness, for example, as inserted in a body orifice. As a practical matter the practitioner may have on hand a large number of the disposable sigmoidoscopes 10 and perhaps only one lighting unit 12. At the same time the practitioner may have a large number of closed end sleeves 28 available. It is not required that the sleeve 28 be physically included with the sigmoidoscope 11 in the same package, for example. However, it is contemplated that one or more sleeves 28 be packed in the same package as contains the sigmoidoscope 11. Sigmoidoscope 11 is placed in a suitable wrapper, for example, a sealed plastic bag to maintain its sterility. Sigmoidoscope 11 may be sterilized previous to packaging as in one operative practice of this invention, or may be placed in a plastic bag and thereafter subjected to ethylene oxide gas treatment for sterilization.
Upon use of this invention the sigmoidoscope 11 complete with a removable obturator is removed from its sterile or sanitary wrapper, and according to standard practices inserted into the proper body opening. The practitioner then procures lighting unit 12 and places a sleeve 28 over rod 23 with flaps 30 and 31 positioned to take up their position as shown in FIG. 1. Then, light unit 12 is inserted into sigmoidoscope 11 and securely attached thereto as heretofore described. Finally, if to be used, eye piece 13 is also fitted to sigmoidoscope 11 as heretofore described. At the completion of the examination the sigmoidoscope assembly 10 is removed from the body cavity by parts in the reverse order mentioned, or the assembly 10 may be removed as a unit. In either event, the sigmoidoscope 11 is permanently discarded, and the sleeve 28 stripped from rod unit 23 and also permanently discarded. At this point rod 23 may be removed from projection 25 if that feature is relied upon to remove lamp 24 from the power circuit. In one preferred embodiment of this invention a recharging unit is provided (not shown) so that housing 21 fits therein for recharging and storage purposes. Such recharging units are well known in the art.
Releasably secured or releasably attached denotes ordinary and usual detaching means, for example, after each use rather than an assembly connection as a structural feature. Single use disposable indicates permanent discarding after a sole use.
The speculum of this invention may be suitably optically darkened to prevent unwanted or undesirable light reflection. In this respect, linear polyolefins are ordinarily opaque with minimal light reflection. One preferred procedure is to reduce the light reflection along the inner surface of tubes 14 and 14a by abrading the surface with a wire brush means or the like. It is also possible to reduce glare by tinting the transparent lens 53 of eye piece 13.
While other modifications of this invention and variations of apparatus may be employed within the scope of this invention and have not been described or illustrated, the invention is intended to include all such modifications as may ordinarily be embraced within the following claims.
What is claimed is:
1. A lighting unit for use with a speculum device including a cylindrical barrel for insertion into a proper body cavity, said lighting unit comprising,
(a) a housing assembly adapted to contain a portable source of electrical power,
(b) means on said assembly to at least partly encircle the exterior of said barrel for releasable attachment thereto,
() support means releasably attached at one end thereof to said housing assembly and extending into said barrel to lie adjacent the wall therein,
(d) lamp means secured to the free end of said support means for providing illumination within said speculum, and
(e) conducting means connecting said lamp means to said source of power, and
(f) separate disposable contamination prevention cover surrounding both said support and lamp means to prevent contamination thereof, said cover comprising an at least partially translucent end thereabout adapted to transmit light through one end thereof and being suitable for a single use and discarding thereafter.
2. The invention according to claim 1 wherein the sleeve includes at least one flap extension at the open end thereof of suflicient length so as to be manually graspable while said light unit is being positioned within said barrel.
3. A light unit for use with a speculum device consisting of a hollow barrel for insertion into a body cavity, a guard secured about said barrel spaced from its proximal end to limit said insertion defining an elongated distal end from said guard, and an eye piece adapted to be detachably secured to said proximal end by means of lugs provided on the internal periphery of said eye piece, said light unit comprising,
(a) a housing assembly adapted to contain a portable electrical power source and to lie adjacent the proximal end of said barrel,
(b) arm means on said housing at least partly encircling said proximal end for releasable attachment to said barrel,
(c) fluid conduit means secured to the outer surface of said arm means communicating between the environment and the inner surface of said arm means,
(d) an axial projection disposed internally of said arm means and adapted to slidably engage an axial slot in the proximal end of said barrel,
(e) hollow rod means detachably secured at one end thereof to said axial projection so as to lie axially within said barrel adjacent the wall thereof,
(f) lamp means capable of providing illumination within said barrel secured to the free end of said rod means, and
(g) conducting means disposed within said rod means connecting said lamp means with said source of power for energization thereof.
4. A light unit for use with a speculum device consisting of:
a hollow barrel for insertion into a body cavity, a guard secured about said barrel and spaced from its proximal end to limit the degree of insertion thereof, an eye piece adapted to be detachably secured to said proximal end by means of lugs provided on the internal periphery of said eye piece, said light unit comprising:
(a) a housing assembly adapted to contain a portable electric power source to be attached about the proximal end of said barrel,
(b) hollow cylindrical means on said assembly encircling at least a portion of the exterior of said proximal end, and adapted for releasable attachment thereto,
(c) fluid conduit means secured to the outer surface of said hollow cylindrical means communicating between the environment and an annular chamber defined by the inner surface of said cylindrical means and the outer surface of said barrel,
(d) an axial projection disposed internally of said hollow cylindrical means and adapted to slidably engage an axial slot, provided in the proximal end of said barrel,
(e) means disposed between the abutting portions of said barrel, hollow means and eye piece, when assembled, to hermetically seal annular chamber,
(f) hollow rod means detachably secured at one end thereof to said axial projection so as to lie axially within said barrel adjacent the wall thereof,
(g) lamp means capable of providing illumination within said barrel secured to the free end of said rod means, and
(h) conducting means disposed within said rod means connecting lamp means with said source of power for energization thereof.
5. The invention as recited in claim 4 wherein a separate disposable contamination prevention means surrounds both said rod and illumination means to prevent contamination thereof, said contamination prevention means being suitable for a single use and discarding thereafter.
References Cited UNITED STATES PATENTS 939,034 11/1909 Kolb l28--6 1,662,227 3/ 1928 Allyn 1287 1,704,397 3/1929 Meitzler 1286 3,032,031 5/1962 Moore 128--6 3,03 8,466 6/ 1962 Moore 1284 FOREIGN PATENTS 1,251,506 12/ 1960 France.
547,291 3/1932 Germany.
RICHARD A. GAUDET, Primary Examiner.
K. L. HOWELL, Assistant Examiner.
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|U.S. Classification||600/121, 600/179|
|Cooperative Classification||A61B1/31, A61B1/06|
|European Classification||A61B1/31, A61B1/06|
|Jun 21, 1982||AS||Assignment|
Owner name: SMITHKLINE BECKMAN CORPORATION
Free format text: CHANGE OF NAME;ASSIGNOR:SMITHKLINE CORPORATION;REEL/FRAME:004080/0769
Effective date: 19820304
Owner name: SMITHKLINE BECKMAN CORPORATION, PENNSYLVANIA