US3631854A - Inflatable medical assemblies - Google Patents

Abstract

This invention provides inflatable, double-walled resilient sleeves for use in forming surgical casts about human and animal body members. In use, such a sleeve is first disposed about the body member and a liquid-curable material such as a foamable polyurethane prepolymer composition, is introduced into the space between the inner and outer walls of the sleeve to inflate the latter. Curing of the liquid material then provides the required rigidification of the sleeve. The invention also embraces the casts so formed and a method for forming the resilient sleeves, usefully by a dipping technique using a novel forming member.

Description

United States Patent [72} Inventor Robert Howard Fryer Aberfoyle Mill, Aberl'oyle, Ontario, Canada 2i 1 App]. No. 825,667 [22] Filed May 19, 1969 [45] Patented Jan. 4, 1972 [54] INFLATABLE MEDICAL ASSEMBLIES 3 Claims, 8 Drawing Figs.

[52] 0.8. CI 128/90, l28/DIG. 20 [51] Int. Cl A6lf 5/04 [50] Field of Search 128/90, 87, 85, 89, DIG. 20

[56] References Cited UNITED STATES PATENTS 2,267,070 l2/l 941 Baldwinl 28/165 3,403,676 10/1968 Gibbons Primary Examiner-Richard A. Gaudet Assistant ExaminerJ. Yasko Attorney-Cecil C. Kent ABSTRACT: This invention provides inflatable, doublewalled resilient sleeves for use in forming surgical casts about human and animal body members. ln use, such a sleeve is first disposed about the body member and a liquid-curable material such as a foamable polyurethane prepolymer composition, is introduced into the space between the inner and outer walls of the sleeve to inflate the latter. Curing of the liquid material then provides the required rigidification of the sleeve. The invention also embraces the casts so formed and a method for forming the resilient sleeves, usefully by a dipping technique using a novel forming member.

INFLATABLE MEDICAL ASSEMBLIES The present invention relates to surgical casts and to a method of forming such casts whereby the setting of fractures and the like may be facilitated. The invention also relates to inflatable sleeves for use in forming such casts and to forming members for use in the manufacture of such sleeves, as well as to a method for forming such sleeves.

A principal object of the present invention is to provide a surgical cast free of many of the well-known problems and disadvantages associated with the use of plaster of Paris for such purpose.

A more particular object of the present invention is to provide a surgical cast which is convenient to apply, which is lightweight and washable, and which is relatively transparent to X-rays.

It is yet another object of the present invention to provide a surgical cast and a method of applying such a cast to a body member which cast and method are characterized by their ease and rapidity of application.

A further object of the present invention is to provide surgical casts which have wide application in the treatment of both human and animal fractures and the like.

Yet another object of the invention is to provide inflatable sleeves which may be used for fonning the surgical casts of the invention.

Other objects of this invention are to provide a method for fonning such inflatable sleeves and novel forming members for use in such a method.

It is a further object of the present invention to provide a flexible, generally fluidtight sleeve for use in combination with the novel surgical casts of the invention for drying a body member covered by such a cast.

A novel surgical cast in accordance with the present invention is broadly defined as comprising a double-walled resilient sleeve having an inner wall and an outer wall circumjacent said inner wall, said sleeve being maintained in a rigidified, inflated condition by a solidified material, such as foamed polyurethane, disposed between said inner and outer walls.

The invention also provides a method of forming a surgical cast about a body member which method comprises disposing an inflatable, double-walled resilient sleeve about said body member, introducing a liquid-curable composition, such as a foaming polyurethane composition, into the space between the walls of said sleeve to inflate said sleeve about said body member, and curing said liquid composition to a solid state within said sleeve.

The present invention also embraces in combination with a novel surgical cast as hereinbefore defined, a flexible, generally fluidtight sleeve having first and second resilient end cuffs, said first end cuff encircling said cast in a generally fluidtight manner and said second end cuff being adapted to encircle in a generally fluidtight manner a body member extending from within said cast, and said flexible, generally fluidtight sleeve having an opening through which air may be blown for passage between said body member and the circumjacent surgical cast.

An inflatable sleeve in accordance with the present invention broadly comprises a resilient inner wall adapted to receive therethrough a body member and, circumjacent said inner wall, a resilient outer wall, said inner and outer walls being terminally secured together in a fluidtight manner to define a space therebetween, and an opening being provided into said sleeve to permit the introduction of a liquid-curable composition into said space between said inner and outer walls.

The invention also provides a novel method for forming such a sleeve. Such a method comprises the steps of (a) forming a continuous tubular sleeve of resilient material on and around a forming member comprising terminally adjacent first and second longitudinal portions, said first longitudinal portion having an external configuration corresponding to the desired internal configuration of said double-walled resilient sleeve, and said second longitudinal portion having larger sectional dimensions that said first longitudinal portion and having an external configuration corresponding to the desired, uninflated, external configuration of said double-walled resilient sleeve, (b) peeling said tubular sleeve from said longitudinal second portion of said forming member so that it is disposed as an outer wall circumjacent said tubular sleeve constituting an inner wall on said forming member, (c) bonding said inner and outer walls terminally together to form said inflatable, double-walled resilient sleeve, and (d) forming an opening in said sleeve for the admission into the space between said inner and outer walls of a curable liquid material.

As hereinbefore indicated, the invention also provides a forming member for use in forming the aforementioned resilient sleeves. Such a forming member broadly comprises an elongated body having terminally contiguous, first and second longitudinal portions adapted to support integrally formed inner and outer walls respectively of a resilient sleeve during a forming operation, said first and second longitudinal portions having different sectional dimensions such that, when said sleeve is peeled from said second longitudinal portion and disposed circumjacent said sleeve from said first portion, a desired separation between said inner and outer walls of the sleeve is obtained.

Other objects, features and advantages of the invention will become apparent as the description herein proceeds.

The invention will now be described merely by way of illustration with reference to the accompanying drawings:

FIG. 1 is a perspective view of a surgical cast in accordance with the invention showing it disposed around a patients forearm;

FIG. 2 is an enlarged, longitudinal sectional view through the surgical cast of FIG. 1;

FIG. 3 is an enlarged, partial longitudinal sectional view through the surgical cast of FIG. 1 showing a particularly useful feature of that cast;

FIG. 4 is a similar sectional view to that of FIG. 2 but illustrating the method according to the invention for forming a surgical cast and more particularly showing the introduction of a foaming liquid composition into the space between the walls of an inflatable, double-walled resilient sleeve disposed around a patients forearm;

FIG. 5 is a representation of two deformable containers containing a precursor material and an activator material, which materials are intermixed prior to the introduction of the resulting foamable mixture as shown in FIG. 4 into the resilient sleeve of the surgical cast;

FIG. 6 is a front elevation showing the use of a forming member in accordance with the invention for forming the inflatable, double-walled resilient sleeve of FIGS 2, 3 and 4 showing such a sleeve partly formed;

FIG. 7 is a longitudinal sectional view through the forming member of FIG. 6 taken along the line 7 --7 of that figure and showing a subsequent stage in the sleeve-forming operation; and

FIG. 8 is a perspective view similar to that of FIG. 1 but also showing the use with the surgical cast of that figure of a flexible, fluidtight sleeve suitable for drying the patients forearm under the cast, for example, after bathing.

Referring first to FIGS. 1 to 3, it will be seen that the surgical cast generally indicated therein at 10 and shown in position around apatients forearm 13 comprises an inflatable, double-walledresilient sleeve 11 having aninner wall 12 and anouter wall 14 circumjacent theinner wall 12. It will be noted particularly from FIG. 2 that thesleeve 11 is closed at each of itsends 15 and 16. Thewalls 12 and 14 are usefully formed from an elastomer and, as will be explained hereinafter, such asleeve 11 can readily be fonned by the novel forming method of the present invention using an elastomer latex dipping procedure.

A solidified liquid material such as a foamedresinous material 18, for example, foamed polyurethane, is disposed within the space between thewalls 12 and 14 and thismaterial 18 serves to maintain thesleeve 11 in inflated condition.Such material 18 also provides the required rigidification of the sleeve 1 1. It will also be appreciated that the actual rigidity of thecast 10 will vary according to the resiliencies of the sleeve 1 1 and of thematerial 18 as well as on the extent to which the sleeve 1 1 is inflated on distended by thematerial 18 contained therein.

It will also be seen from FIGS 1 and 2 that the foamedresinous material 18 extends outwardly at 20 through an opening 21 in theouter wall 14 of thesleeve 11, this opening 21 being provided to permit the introduction of theresinous material 18 into the space between thewalls 12 and 14 as will be explained in more detail hereinafter with reference to the application of thecast 10 about a patients body member, for example, the patients forearm 13. It will further be understood that, once thecast 10 is formed, the opening 21 is sealed by theplug 20 of resinous material.

lN accordance with useful feature of the invention, the inner surface of theinner wall 12 adapted to be disposed in surface contact with a body member, for example, theforearm 13, is formed with a plurality of inwardly projecting protuberances or dimples 22 to pennit some circulation of air between thecast 10 and the enclosed body member for such purposes as permitting drying of the skin, for example, after bathing, or for allowing free evaporation of perspiration. If desired, the inner surface of thecast 10 may also be flocked as shown at 24 in FIG. 3.

In accordance with another useful feature of the invention, thecast 10 is also usefully provided at each of itsends 15 and 16 with a resilient, preformedcollar 25, 26 respectively, each of which is disposed between the inner andouter walls 12 and 14 respectively.Such collars 25 26 provide some degree of dimensional stability to thecast 10 while it is being positioned and filled about a body member as well as facilitating the introduction of thematerial 18 into the space between thewalls 12 and 14. However another reason is to provide comfort should the wearer flex a limb, by providing resiliency, since the cast is hardened between the ends.

Having described the structure of thesurgical cast 10, reference will now be made to FIGS. 4 and to describe the manner in which the cast is formed about a body member such as theforearm 13. In such a procedure, the inflatable, double-walledresilient sleeve 11 in its deflated form is first disposed about the body member. It should be noted that, for theparticular sleeve 11 shown in FIG. 4, thecollars 25 and 26 are secured between the inner andouter walls 12 and 14 during the manufacture of such sleeve and that the opening 21 already mentioned is defined by an outwardly extendingnipple 28. Having disposed thesleeve 11 correctly about theforearm 13, a liquid, curableresinous composition 30 is introduced into the space between thewalls 12 and 14. The liquidresinous composition 30 is usefully introduced into thesleeve 11 from a primary deformable container or tube 32 (FIG. 4) having atubular neck 34 gripped by thenipple 28. Compression or other deformation of the container ortube 32 then forces theliquid composition 30 into thesleeve 11 as will readily be understood by reference to FIG. 4.

In accordance with another useful feature of the present invention, thetubular neck 34 of theprimary container 32 is provided with an externalannular lip 35 which serves to provide a generally fluidtight engagement with thenipple 28. Once the introduction of theliquid composition 30 into thesleeve 11 has proceeded to the desired extent, the liquid material is cured within the sleeve to a solid state to provide the required rigidification of thecast 10. Theprimary tube 32 is then removed from thesleeve 11 and theprotruding nipple 28 which is plugged with solidified material is then severed to provide a level outer surface for thecast 10.

Many suitable liquid curable compositions can be used for forming surgical casts in accordance with the present invention. For instance, resinous liquid compositions can be used which are self-curing and which are prepared a short time before use in view of their limited shelflives. Alternatively, compositions may be used which have long shelf lives but which require the application of an external stimulus such as heat, ultraviolet radiation, etc., to initiate or effect their curing to a solid state. Obviously, the liquid material must be one which is capable of being cured to a solid state under conditions which can be tolerated by the body member contained within the cast.

Although the present invention embraces the use of nonfoaming liquid compositions, particularly effective casts have been formed by the use of foamable compositions such as those comprising polyurethane materials. With such materials, it is convenient to prepare theliquid composition 30 just prior to use and to introduce such a composition immediately into thesleeve 11 to allow the foaming to proceed the in situ. Such use of polyurethane compositions advantageous in that the curing times of such compositions are very short, being of the order of five minutes or less.

With this procedure, the reactive component materials from which the foamable liquid composition is prepared are usefully supplied in separate containers for intermixing when required. For convenience, such two-component systems will be referred to herein and in the claims appended hereto as comprising a precursor material" and a separate activator material." In the case of polyurethane compositions, the precursor material may, for instance, comprise a suitable liquid prepolymer while the activator material may comprise a catalyst eflective for completing the curing and foaming of the prepolymer to a solid foamed state. It should be under stood, however, that the invention is not restricted to the use of any specific liquid curable compositions and that many suitable combinations of precursor materials and activator materials which will provide curable liquid compositions having the required properties can be used in the method of the invention.

Referring now, merely by way of further illustration, to FIG. 5 of the accompanying drawings, it can be explained that a precursor material such as aliquid polyurethane prepolymer 31 is supplied in the primary deformable container ortube 32, thetubular neck 34 of which has afemale thread 36 for engagement with a male-threadedclosure cap 38. A suitable activator material such as acatalyst 39 for use with theparticular prepolymer 31 is separately supplied in a secondary deformable container ortub 40 having aneck 41 with amale thread 42 and a cooperating female-threadedclosure cap 43. For a reason which will become apparent as the description herein proceeds, theprimary container 32 is only partially filled with theprepolymer 31. Thethreads 36 and 42 of the containers ortubes 32 and 40 respectively are adapted to interengage as will be explained. When it is required to prepare theliquid material 30 for introduction into the sleeve 1 1 in the manner already described, the closure caps 38 and 43 are removed from thetubes 32 and 40 respectively and theneck 41 of thesecondary tube 40 is screwed into theneck 34 of theprimary tube 32. Thecatalyst 39 is then transfered from thesecondary tube 40 to theprimary tube 32 by squeezing the former for thorough mixing in theprimary tube 32 of thecatalyst 39 with theprepolymer 31 contained therein. Such mixing can be facilitated by the use of aresilient tube 32. The required mixing can then be effected by kneading thetube 32. It may also be advantageous to incorporate a dye or other coloring agent into one of thecomponent materials 31 and 39 so as to provide a visual indication when the required degree of mixing has been obtained. In this case, thetube 32 may usefully be formed of a transparent or translucent material. When such mixing is complete, the liquid mixture is then transferred from thetube 32 into thesleeve 11 as already described with reference to FIG. 4. Foaming of the liquid composition occurs rapidly as indicated at 46 to inflate the sleeve 1 1.

Having described the use of thesleeve 11 for forming asurgical cast 10, reference will now be made to FIGS. 6 and 7 to describe a particularly useful procedure and a forming member in accordance with the invention for forming such asleeve 11.

Referring first to FIG. 7, it will be noted that a forming member or mould indicated generally therein at 50 comprises an elongated body having terminally contiguous, first and second,-frustoconicallongitudinal portions 51 and 52 with their larger ends disposed generally centrally at 53. For a reason which will be understood as the description herein proceeds, thesecond portion 52 has sectional dimensions greater than those of thefirst portion 51. Consequently, ashoulder 54 is provided between the twoportions 51 and 52.

The peripheral surface of the first orlower portion 51 of the formingmember 50 is provided withsurface irregularities 56 which serve to provide the aforementioned protuberances or dimples on the inner surface of theinner wall 12 of the sleeve 1 1 used in forming thesurgical cast 10.

In forming a sleeve such assleeve 11 using the formingmember 50, the latter is first dipped into abath 58 of rubber orother elastomer latex 60 and then removed therefrom. Such dipping provides a surface coating of latex on the formingmember 50. This coating is then dried by any suitable procedure, the coating on the first orlower portion 51 of the formingmember 50 providing theinner wall 12 of the sleeve 1 l and that on thesecond portion 52 providing theouter wall 14 of thesleeve 11. After the latex coating on thefonner 50 has dried sufficiently,resilient collars 25 and 26 are disposed about thefirst portion 51 of the fonningmember 50 so as to be circumjacent the longitudinal ends of theinner wall 12. If desired, thesecollars 25 and 26 may be bonded in any ap propriate manner to the underlyinginner wall 12, for example, by the use of a suitable adhesive composition.

Referring further to FIG. 7, it will be seen that the upper orsecond portion 52 of the formingmember 50 is provided with anannular recess 64 extending generally radially inwardly from its peripheral surface. During the aforementioned dipping operation, thelatex 60 is received within thisrecess 64 to form thetubular nipple 28 utilized subsequently for introducing thecurable liquid composition 30 into the sleeve 1 1.

With thecollars 25 and 26 correctly disposed around theinner wall 12 as shown in FIG. 6, theouter wall 14 is peeled from the second orupper portion 52 of the formingmember 50 and disposed circumjacent theinner wall 12 around thelower portion 51 of the formingmember 50 as shown in FIG. 7. The adjacent lower ends of thewalls 12 and 14 are then bonded to each other in any suitable manner, for example, by a further latex dipping operation or by the use of a suitable adhesive composition.

It will be appreciated that, with the forming operation hereinbefore described with reference to FIGS. 6 and 7, it will be necessary to remove the rubber end portion shown at 66 in first 7. This may be effected before or after removal of thesleeve 11 from the formingmember 50. Although thesleeve 11 has been described as having a tapered configuration, it will be understood that sleeves of other configurations, for example, cylindrical ones, may just as readily be formed in the manner described.

Referring finally to FIG. 8 of the accompanying drawings, there is shown therein, in combination with acast 10 as already described, a flexible, generally fluidtight, fabric or plastic sleeve having first and second, resilient end cuffs 71 and 72. As will be seen, one of these cufi's, for example,cuff 71, may be disposed so as to encircle thecast 10 in a generally fluidtight manner in proximity to theend 16 thereof while thecufi 72 may then be disposed so as to encircle in a generally fluidtight manner the patients arm extending from within thecast 10. Thesleeve 70 has an opening with an associated fitment through which air may be blown for passage between the forearm l3 and thecast 10. Such asleeve 70 is particularly useful in that it permits air to be blown beneath the cast for drying purposes, for instance, if the body member is wetted, for example, during bathing. Thefitment 73 may usefully be adapted to be connected releasably to ahose 74 from a vacuum cleaner, hair dryer or the like.

What is claimed is: l. A surgical cast comprising a double-walled resilient sleeve having an inner wall and an outer wall circumjacent said inner wall, said sleeve being maintained in a rigidified, inflated condition by a solidified material disposed between said inner and outer walls an opening extending through said outer wall said opening being sealed by said solid material, said inner surface being adapted to be disposed in surface contact with a body member, said inner surface being formed with a plurality of inwardly projecting protuberances to permit circulation of air between said cast and a body member enclosed thereby, and at least one resilient, preformed collar disposed between said inner and outer walls.

2. A surgical cast as defined in claim 1 which cast comprises first and second, resilient, preformed collars disposed between said inner and outer walls terminally thereof.

3. In combination, with a surgical cast comprising a doublewalled resilient sleeve having an inner wall and an outer wall circumjacent said inner wall, said sleeve being maintained in a rigidified, inflated condition by a solidified material disposed between said inner and outer walls, a flexible generally fluidtight sleeve having first and second resilient end cuffs, said first end cufi' encircling said cast in a generally fluidtight manner and said second end cuff being adapted to encircle in a generally fluidtight manner a body member extending from within said cast, and said flexible, generally fluidtight sleeve having an opening through which air may be blown for passage between said body member and the circumjacent surgical cast.

* i t i I

Claims (2)

1. 2. A surgical cast as defined in claim 1 which cast comprises first and second, resilient, preformed collars disposed between said inner and outer walls terminally thereof.
2. 3. In combination, with a surgical cast comprising a double-walled resilient sleeve having an inner wall and an outer wall circumjacent said inner wall, said sleeve being maintained in a rigidified, inflated condition by a solidified material disposed between said inner and outer walls, a flexible, generally fluidtight sleeve having first and second resilient end cuffs, said first end cuff encircling said cast in a generally fluidtight manner and said second end cuff being adapted to encircle in a generally fluidtight manner a body member extending from within said cast, and said flexible, generally fluidtight sleeve having an opening through which air may be blown for passage between said body member and the circumjacent surgical cast.

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