U.S. patent number 3,774,596 [Application Number 05/157,825] was granted by the patent office on 1973-11-27 for compliable cavity speculum.
Invention is credited to Galen B. Cook.
United States Patent |
3,774,596 |
Cook |
November 27, 1973 |
COMPLIABLE CAVITY SPECULUM
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.
Inventors: |
Cook; Galen B. (Pebble Beach,
CA) |
Family
ID: |
22565434 |
Appl.
No.: |
05/157,825 |
Filed: |
June 29, 1971 |
Current U.S.
Class: |
600/184; 600/207;
600/208; 606/192 |
Current CPC
Class: |
A61B
1/31 (20130101); A61B 1/32 (20130101); A61M
29/02 (20130101) |
Current International
Class: |
A61B
1/12 (20060101); A61M 29/00 (20060101); A61B
1/31 (20060101); A61B 1/32 (20060101); A61b
001/30 (); A61b 001/32 (); A61m 029/00 () |
Field of
Search: |
;128/3,4,5,6,7,8,242,243,244,341,343,344,345 |
References Cited
[Referenced By]
U.S. Patent Documents
Foreign Patent Documents
Primary Examiner: Pace; Channing L.
Claims
What is claimed is:
1. A cavity inspection device comprising:
a base member, said base member including an elongated portion
having a substantially flat top wall and a tip portion attached to
said elongated portion, said tip portion having at least one
surface extending upwardly above said top wall;
a foldable tubular structure mounted to said top wall having at
least a folded position and an unfolded position, said tubular
structure having a longitudinal opening therethrough in its
unfolded position, said tubular structure lying below the upwardly
extending surface of said tip portion in the folded position of
said tubular structure, said tubular structure including an outer
wall, an inner wall joined to said outer wall to define an
inflating channel therebetween, and a plurality of rods carried
between said outer wall and said inner wall; and
means for unfolding said foldable tubular structure.
2. The device of claim 1 wherein said foldable tubular structure is
a hexagonal shape in cross section in its unfolded position, said
rods being carried along the vertices of said hexagonal shape.
3. The device of claim 2 wherein said inner and said outer walls
have a plurality of openings in them which permit access through
said inner and said outer walls from the longitudinal opening in
said foldable tubular structure.
4. A cavity inspection device comprising:
a base member, said base member including an elongated portion
having a top wall and a tip portion attached to said elongated
portion, said top portion having at least one surface extending
upwardly above said top wall for a predetermined height, said base
member having sufficient rigidity to permit its insertion into a
body cavity;
an unfoldable tubular structure having a folded and an unfolded
state mounted to said top wall, said unfoldable tubular structure
lying below the predetermined height of said upwardly extending
surface in its folded state and having an unobstructed longitudinal
opening through it in its unfolded state, said unfoldable tubular
structure including an outer wall, and an inner wall joined to said
outer wall to define an inflating channel therebetween; and
means for unfolding said tubular structure.
5. The device of claim 1 wherein said inner and outer walls have a
plurality of openings in them, permitting communication from said
longitudinal opening in said tubular structure outwardly through
said side walls.
6. The device of claim 5 wherein said tubular structure forms a
polyhedron having a hexagonal cross section, further characterized
by a plurality of rods carried between said inner and said outer
walls along the vertices of said polyhedron.
7. A cavity inspection device comprising:
a base member including a first tip portion and a second portion
joined to said tip;
a foldable side wall section attached to said base member having a
folded and unfolded position, said foldable side wall section
having an unobstructed longitudinal opening therethrough in its
unfolded position, the diameter of said longitudinal opening in the
unfolded position of said side wall being substantially larger than
the diameter of said cavity inspection device when said foldable
side wall section is in its folded position, said foldable side
wall section comprising an outer wall, an inner wall joined to said
outer wall to define an inflating channel therebetween and a
plurality of rods carried between said outer and said inner walls;
and
means for unfolding said foldable side wall section.
8. The device of claim 7 wherein said side wall section has a
plurality of openings in it permitting egress through said opening
plurality from said longitudinal opening.
9. The device of claim 8 wherein said foldable side wall section is
a hexagon in cross section in its unfolded position, said rods
being carried along the vertices of said hexagon.
Description
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 compliable 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
compliable 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 compliable 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 compliable 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 compliable 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 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 inserted, 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 compliable, 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 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.
* * * * *