Compliable cavity speculum

[57] ABSTRACT

A device for the inspection of body cavities has collapsible walls. The walls are folded both during storage and during insertion into and retraction from the body cavity to be examined. After insertion, means are provided for unfolding the walls, thereby expanding the cavity, which permits access to the cavity for the purposes of inspection, diagnosis, or treatment. The walls are supported by axial rods running along the wall periphery. In the preferred embodiment, the walls are double layer plastic sealed to form a plurality of channels. The channels alternately are pressurized to expand the device during examination and depressurized to permit its contraction and withdrawal. The walls have a plurality of clear window-like areas which facilitate the examination procedure.

Claims, 7 Drawing Figures

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Patented Nov. 27, 1973

3,774,596

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inventor:

GALEN B. COOK

Patented Nov. 27, 1973

3,774,596

Sheets-Sheet 2

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FIG. 5.

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FIG. 7.

inventor:

GALEN B. COOK

<img file="US3774596A_D0006.tif" />

3,774,596

COMPLIABLE CAVITY SPECULUM

BACKGROUND OF THE INVENTION

This invention relates to medical instruments designed to permit inspection of body cavities. While the invention is described with particular reference to the human body, those skilled in the art will recognize the applicability of my invention to other animals and inanimate objects.

Structural and chemical changes occur within the body cavities of animals under both physiologic and pathologic conditions. Consequently, it frequently is desirable to determine the nature of these changes in order to discriminate between healthy and diseased conditions. Where disease is suspected or present, it is desirable to learn the etiology and characteristics of the disease. Useful data is obtainable, in many instances, from both the living and the dead.

In addition to gaining access to body cavities for diagnosis, these cavities frequently must be approached for treatment and the application of therapies. Instruments designed for these purposes should be mechanically reliable. Their special application, however, further requires that they be safe, tolerable and relatively painless for the subject, easily cleansed or disposable after a single use, and comparatively inexpensive. The prior art exhibits a number of devices designed for cavity inspection. While these prior art instruments work well for their intended purpose, they conventionally are made from steel or other rigid material and require the examined tissue area to conform to the fixed contours of the instrument rather than being adaptable to variations of the examined area. Present instruments also must be manufactured in a range of sizes because the sizes of body cavities are dissimilar in different people.

Existing devices often cause pain when introduced into the body, manipulated or removed. They may pinch or tear tissues. Conventionally being metal, they are cold to the touch and uncomfortable to the subject. My invention provides an instrument that is pliable even in its extended form.

One of the objects of this invention is to provide a low cost cavity inspection device.

Another object of this invention is to provide a cavity inspection device which is disposable after use.

Yet another object of this invention is to provide a cavity inspection device that is compilable after expansion within the inspected area.

Still another object of this invention is to provide a cavity inspection device which is easy to introduce, manipulate and remove from the body.

Yet another object of this invention is to provide a single cavity inspection device which may be used for a broad range of patients having differing physical constitutions.

Other objects of this invention will be apparent to those skilled in the art in light of the following description and accompanying drawings.

SUMMARY OF THE INVENTION

In accordance with this invention generally stated, an expandable device for the inspection of body cavities is provided which has compilable side walls enabling the device to conform to the inspected cavity.

In the preferred embodiment, the walls are supported by axially extending rods arranged to permit the supported walls to be folded together. A pressure conduit network is carried by the walls such that when external pressure is applied to the network the walls unfold to assume a hollow polyhedral structure having a longitudinal opening therethrough. The walls have a plurality of open or transparent areas which permit visual inspection of surrounding tissue. The longitudinal opening allows the use of external illumination and the insertion of additional medical instruments, remedies for further diagnostic purposes, or other treatment aids.

BRIEF DESCRIPTION OF THE DRAWINGS

In the drawings,

FIG. 1 is an enlarged view, in perspective, of a compliable cavity speculum of my invention;

FIG. 2 is a view in side elevation of the compilable cavity speculum illustrated in FIG. 1;

FIG. 3 is a sectional view taken along the line 3—3 of FIG. 2;

FIG. 4 is a top plan view of the compilable cavity speculum of FIG. 1, illustrating the deflated and folded position of that instrument;

FIG· 5 is a view in side elevation of the instrument in the deflated and folded position shown in FIG. 4;

FIG. 6 is a view taken along the line 6—6 of FIG. 5; and

FIG. 7 is a somewhat diagrammatic view of the compliable cavity speculum of FIG. 1 shown partially inflated and unfolded.

DESCRIPTION OF THE PREFERRED EMBODIMENT

Referring now to FIG. 1, reference numeral 1 indicates an illustrative embodiment of compilable cavity speculum of this invention. Device 1 includes a base 2, an inflating means 3, and a tube structure 4.

Base 2 has a broad rectangular support area 5 and a tip 6. Tip 6 rises above area 5 along a step 7. Tip 6 has a rounded outer surface 8 and a flat upper surface 9. The design of tip 6 is important, as tip 6 acts as the leading edge for the device during insertion. The height of step 7 is chosen so as to be greater than the height of the folded tube structure 4, as is explained fully hereinafter. Base 2 may be constructed from any convenient material. Plastic works well because of its low cost and insensitivity to temperature change, although other materials, including metal, are satisfactory. It is important, however, that base 2 have sufficient structural rigidity to permit insertion and withdrawal without bending or deforming. The use of plastic eliminates trauma to the patient caused by temperature variations between the instrument and body temperature common, for example, with the metal instruments now in use.

Tube structure 4 is constructed from two layers of plastic material which provide structure 4 with an outer wall 10 and an inner wall 11. As will be explained herein, walls 10 and 11 are heat sealed or cut selectively to provide a plurality of windows 12 and an air channel system 13. Air channel 13, in the embodiment illustrated, consists of the material thickness of walls 10 and 11 sealed to enable the structure to retain an inflating liquid or gas at relatively low pressure.

The preferred embodiment utilizes a tubular structure 4 hexagonal in cross-section having sides 14, 15,

16, 17, 18 and 19. The structure is supported in its open position, illustrated in FIG. 1, by a plurality of axial rods 20 fixed between outer wall 10 and inner wall

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11. Structure 4 is mounted on base 2 along a portion of wall 17, by any convenient method. Adhesive works well. Rods 20 may be constructed from a variety of materials. I prefer plastic because of its flexibility, low cost and temperature insensitivity. Other materials work well, provided they are flexible enough to permit conformance to the inspected cavity by structure 4, yet sufficiently resilient to permit the rods 20 to assume their original shape after use.

Construction of tube stucture 4 is simple. Inner wall 11 need be nothing more than a single sheet of plastic material pre-selectively sized to give a desired diagonal diameter for the expanded structure 4. Outer wall 10 is sized in the same manner as inner wall 11. Wall 10, however, must be slightly longer in length than wall 11 in order to permit folding of the tube structure 4. Wall 10 has a plurality of openings 21 cut in it, along what become the vertices of the polyhedral tube structure 4. Rods 20 are placed on interior wall 11 along the vertices. Wall 10 is then positioned over wall 11 and rods 20 and selectively heat sealed as described above. The resulting patterned rectangular double sheet is then joined to form an open-ended tubular structure having an axial opening 22 therethrough.

Prior to sealing, inflating means 3 is placed between walls 10 and 11. Inflating means 3 may be any of a variety of inflating structures. In the embodiment illustrated. inflating means 3 is nothing more than a hollow tube 23 connected to air channel system 13. Tube 23 in turn is connected to a bulb and valve arrangement, not shown, which is used to inflate the air channel system 13 with air and to secure system 13 in an inflated condition for use. A sufflating bulb and valve, similar to those used to inflate sphygmomanometer cuffs work well for most applications. While system 13 is described as an air system, those skilled in the art recognize that other fluids may be used for the inflating process. Each end 24 and 25 of structure 4 is important. The ends act both to close air system 13 and to join the axial conduits formed in the sealing process. Additionally, the rods 20 are fixed positionally by those ends. That is, the rods 20 are held between the walls 10 and 11 and fixed thereby while the air system 13 surrounds and is independent from the rods 20. Such construction is obtainable easily during the sealing process described above.

While I have described windows 12 as clear plastic formed in the sealing process, those skilled in the art recognize that windows 12 may be cut out from both walls 10 and 11, the channel 13 alone being formed by selective heat sealing. Cut out windows are preferred if medicaments are to be applied.

The resulting tubular structure is folded to form the final hexagonal design, and mounted on base 2. Once attached, the sides are folded atop one another so that the rods 20 are all on one side of the folded device, as may best be seen in FIGS. 5 and 6. That is, side 17 of the polyhedral structure is attached both to base 2 and to the top of the folded structure shown in FIG. 6. This is important. First, it insures proper side wall expansion. Second, it maintains the deflated side wall structure in a compact mass below the height of step 7.

The device preferably is supplied as a pre-sterilized unit. It may be maintained in a sterilized condition by a common plastic bag not shown. The bag also prevents inadvertent unfolding of the device. In use, the bag is ruptured by pulling it against tip 6. Tip 6 is then in4 serted, but the bag is not removed until after the device is positioned in the body cavity to be examined. Such procedure aids in retaining the folded sides compacted and below step 7 height.

Once in position, the device is inflated through means 3. Each side of structure 4 unfurls successively, as is best shown in FIG. 7. As the air system 13 network fills, the rods 20 at each vertex are forced apart. When fully inflated, the rods are held in a position of maximum separation. This in turn forces the examined cavity open. Since the device is compilable, the tissue and structure 4 conform to one another so that the tissue of the examined cavity bears against the windows 12. In addition, the diameter of the expanded tube structure 4 may be adjusted to the individual examined merely by adjustment of the air held by the air system 13.

Tube structure 4 is sized to permit various examining instruments to be inserted into the cavity. For example, external illumination may be utilized or other diagnostic aids may be inserted through opening 22. Simple extraction of the device of my invention is provided after use. The device 1 merely is deflated and extracted. Since the preferred embodiment is plastic, it may be cleansed and sterilized if reuse is desired. However, the individual low cost of the unit permits its disposal after a single use.

Numerous variations within the scope of the appended claims will occur to those skilled in the art in the light of the foregoing description and accompanying drawings. For example, the shape of tubular structure 4 may be varied. Thus, triangular, square, or other geometric shapes may be used for the tube structure cross-section, although such shapes may not lend themselves equally well to compact folding. Windows 12 may be cut through both outer wall 10 and inner wall 11, particulary where application of remedies, in addition to visual inspection, is desired. Tip 6 may be redesigned to facilitate entrance and withdrawal in special applications. Although I prefer windows 12 in all sides of structure 4, other embodiments of my invention may utilize a structure 4 with some sides of solid material. The design of ends 24 and 25 may be varied, particularly when solid material is used for side construction. Certain embodiments of my invention may utilize an expandable side wall construction without the need for axial rods 20. For example, device 1 may be a hollow, tapered, cylindrical structure having two adjacent side portions hingedly mounted to the remainder of the cylindrical structure. The side portions, in turn, may have an inflatable, folded expansion joint between them. The device thus would present a streamlined structure for insertion ease. Expansion of the joint would drive the side portions apart and expand the surrounding cavity. While an inflatable side wall structure has been described, combination inflating and deflating means may be utilized. For example, the side wall construction of structure 4 may comprise dual channels. One channel may contain very fine granular material and be provided with an exhaust valve. The second channel can be the air channel described above. Such construction is accomplished easily by the use of a third sheet of plastic material, along with walls 10 and 11, in the formation of structure 4. After insertion, the device is inflated as described. Thereafter, a suction tube is attached to the exhaust valve of the first channel. As air is exhausted from this channel, atmospheric pressure presses the granular material together forming a solid

3,774,596 mass. The vacuum tube then can be removed and the device will maintain its shape. Release of the vacuum and of the air in the first and second channels respectively causes collapse of the device, allowing its extraction. Granular material and its reaction under vacuum are well known in the art, having gained acceptance for patient positioning systems. These variations are merely illustrative.