US3707146A

US3707146A - Means to inject a plastic into a cavity to produce a replica thereof

Info

Publication number: US3707146A
Application number: US621174A
Authority: US
Inventors: Ralph J Cook; Clifford C Moline; Joseph M Schumann
Original assignee: Product Research and Chemical Corp
Current assignee: Product Research and Chemical Corp
Priority date: 1967-03-07
Filing date: 1967-03-07
Publication date: 1972-12-26
Anticipated expiration: 1989-12-26
Also published as: SE351980B; DK116467B; DE1616492B2; DE1616492A1; FR1605173A; GB1204962A; SE352813B; DK123745B; GB1204961A; DE1616493A1; FR1595545A; CA921789A; DE1616493B2

Abstract

The particular embodiment of the invention disclosed herein is specifically designed to produce a soft resilient plastic impression of the interior configuration of a body cavity, the invention having special utility for the purpose of medical diagnosis for exploring the lower portion of the large intestine. For this purpose, the invention provides a catheter for insertion into the body cavity in combination with a disposable cartridge containing isolated ingredients of a fast curing polymer, the cartridge being adapted for rapid preparatory intermixture of the ingredients and immediate extrusion of the mixture to and through the catheter.

Description

United 1 States Patent Cook et al.

[54] MEANS TO INJECT A PLASTIC INTO A CAVITY TO PRODUCE A REPLICA THEREOF [72] Inventors: Ralph J. Cook, Torrance; Clifford C. Moline, Malibu; Joseph M. Schumann, Inglewood, all of Calif.

[73] Assignee: Products Research 81 Chemical Corporation, Burbank, Calif.

[22] Filed: March 7, 1967 211 Appl. No.: 621,174

52 U.S. c1. ..12s/2 11, 128/246, 128/349 13 [51] 1111.01. ..A6lb 05/10 [58] Field of Search ..128/2, 21:; M, 218 NV, 220, 128/230, 234, 235, 237, 240-246, 276, 344,

[56] References Cited UNlTED STATES PATENTS 2,330,399 9/1943 Winder ..128/349 2,804,075 8/1957 Borden ..128/277 3,459,175 8/1969 Miller ..128/2 1,924,916 8/1933 Drake ..128/234 2,457,244 12/1948 Lamson ..128/246 2,676,591 4/1954 FOX 1 51 Dec. 26, 1972 6/1956 Wallace ..128/295 2,869,543 1/1959 Ratclit'f et al. ..123/218 M 2,869,544 1/1959 Ratcliff et al ..128/220 3,144,966 8/1964 Cook ..222/136 3,164,303 1/1965 Trautmann 222/136 X 3,195,778 7/1965 Coates ..222/1 36 X 3,247,841 4/1966 Cook 128/2 3,370,754 2/1968 Cook et al 128/218 M X Primary Examiner-Dalton L. Truluck Attorney-Smyth, Roston & Pavitt [57 ABSTRACT The particular embodiment of the invention disclosed herein is specifically designed to produce a soft resilient plastic impression of the interior configura- -tion of a body cavity, the invention having special utility for the purpose of medical diagnosis for exploring the lower portion of the large intestine. For this purpose, the invention provides a catheter for insertion into the body cavity in combination with a disposable cartridge containing isolated ingredients of 24 Claims, 9 Drawing Figures PATENTED DEC 26 1912 SHEEI 1 OF 3 p 3% Mm wan.

M M m ca r 4 6 r in 4. 5

PATENTED w: 2 I912 3. 707. 146

' sum 2 or 3 Jars ab M 5651/014/7/7 MEANS TO INJECT A PLASTIC INTO A CAVITY TO PRODUCE A REPLICA THEREOF BACKGROUND OF THE INVENTION Broadly described the invention is a means for injecting a fast curing plastic into a cavity to produce a replica of the interior configuration of the cavity where the shape of the cavity would make it impossible to withdraw a rigid replica from the cavity. The required replica is produced by a plastic that cures to form a soft resiliently deformable plastic body that is capable of yielding in shape as required for withdrawal and when withdrawn may be relied upon to return to the exact configuration of the cavity.

Medical diagnosis by this procedure has now become possible by the development of a plastic material that has the following necessary characteristics: (1) physiologically inert in the sense of being harmless to internal surfaces of the human body; (2) sufficiently fluent in uncured state for extrusion from a dispensing container into a body cavity; (3) quick setting to cure in a short time period, preferably well under 5 minutes;

(4) capable of being molded to stable solid state by A surfaces; (5) rubber-like when cured and sufficiently soft and resilient for yielding distortion as required for withdrawal through restricted portions of the body cavity without physical harm to the tissues and without undue discomfort to the patient and capable after such distortion of returning to precisely the configuration of the cavity. A suitable plastic for this purpose that is produced by The Dow Chemical Co. and is available from Travenol Laboratories Inc., Morton Grove, lllinois, is a polysiloxane foam produced by catalyzing a silicon polymer by stannous octoate; Mixing together the polymer and catalyst produces a fluent uncured plastic which begins to cure in less than 1 minute and completely cures in approximately 3 minutes.

One subcombination of the structure for practicing the invention is a suitable catheter'through which the uncured plastic is extruded from a dispensing container into a body cavity such as the lower portion of the large intestine. It has heretofore been proposed to provide such a catheter with a guard flange to limit the extent to which the catheter may be inserted into a body cavity and it has also been proposed to provide the catheter with an enlargement for the dual purpose of retaining the catheter in the body cavity and of preventing reverse extrusion of the uncured plastic out of the body cavity. It has been further proposed to provide such an enlargement in the form of a thin walled cuff that may be collapsed to facilitate insertion of the catheter and after insertion may be inflated to an effective size by an external means, for example, by a pump in the form of an elastomer bulb.

One problem relating to such a catheter that is solved by the present invention is that while such an enlargement is effective for its two purposes, nevertheless it cannot be depended upon to prevent leakage from the body cavity of small amounts of fluid including body fluids and residuals of fluids previously introduced to evacuate the cavity in preparation for the molding operation.

Another problem solved by the invention arises from the fact that a passage space of substantial volume exists between the dispensing port of the container and the nozzle of the catheter. Displacement of the air from this passage space into the body cavity by extrusion of the plastic interferes with the injection of the plastic and results in trapping of air in the cavity with consequent deformation of the molded plastic.

A second subcombination of the invention is a dispensing container in the form of a disposable cartridge that stores the polymer and catalyst in separate compartments and is adapted not only for intermixing the two ingredients but also for connection to the catheter for prompt extrusion of the uncured plastic into the body cavity.

Examples of multiple compartment disposable cartridges capable of mixing and dispensing uncured plastic are disclosed in the Cook U.S. Pat. No. 3,144,966 in Class 222, Sub Class 136 and in the Cook U.S. Pat. No. 3,153,531 in Class 259, Sub Class 113. While these priorvart cartridges are effective for their intended purposes of mixing and dispensing sealants for industrial use they are not suitable for the present invention because of the requirement that the separate ingredients be thoroughly intermixed and dispensed into the body of the patient within the total time period of 45 seconds. In both disclosures of the two abovementioned Cook patents, the ingredients are intermixed by a dasher on an operating rod that extends through the dispensing port of the cartridge and normally closes the dispensing port. Consequently, the operating rod must be withdrawn to open the dispensing port afterthe mixing operation and in addition further manipulation of the cartridge structure is required to ready the cartridge for actual extrusion of the uncured plastic.

An important problem to which the present invention is directed is to avoid these disadvantages by providing a disposable dispensing cartridge that may be manipulated in a simple and convenient manner to intermix the different ingredients and to dispense the mixture, all within 30 seconds without requiring specialized skill or even experience and practice. This problem involves the more specific problem of providing a simple, reliable, fool-proof and easily explained step-by-step procedure for producing the desired diagnostic plastic replica.

Other more specific problems to which the invention is directed include: elimination of the need for manipulating a dasher by means extending through the dispensing port of the cartridge so that the dispensing port may be continuously available for transferring the uncured plastic to the catheter; the problem of providing an operating rod that may be freely reciprocated through a dispensing piston independently of the piston to actuate a dasher beyond the dispensing piston, which operating rod may be subsequently directly connected to the dispensing piston for the purpose of extruding the plastic mixture; the problem of providing a positively locked dispensing valve to prevent premature extrusion of the mixture through the dispensing port of the cartridge without the penalty of losing precious time to unlock the valve; the problem of enabling the normally closed dispensing valve to open automatically in response to the step of connecting the cartridge to the catheter; the problem of providing a dispensing cartridge in which the mixing operation may be carried out while the cartridge is connected to the catheter, thus making it possible to connect the cartridge in advance if it is desired to eliminate the necessity of making the connection during the allowed 30 seconds; and the problem of constructing the catheter and dispensing cartridge so economically that the whole combination may be disregarded after one use to avoid the need for cleaning and sterilizing the combination for repeated use.

SUMMARY OF THE INVENTION the guard flange and the body of the patient to accommodate a suitable sponge and by providing such a sponge in the form of a collar made of foamed plastic or the like. Such a collar may be easily mounted on the catheter or removed from the catheter while the catheter enlargement is deflated. The sponge collar not only captures and retains the leakage fluid but also serves as a cushion for the flanged guard to minimize discomfort to the patient.

The problem created by the presence of air in the passageway between the dispensing port of the cartridge and the nozzle of the catheter is solved by providing a vent tube which establishes communication between the ambient atmosphere and the interior of the catheter nozzle. It has been found that such a vent tube may serve its purpose even when it is sufficiently restricted to prevent any significant diversion of the advancing plastic along the vent path.

The problem of avoiding use of the dispensing port at the front end of the cartridge for carrying out the mixing operating is solved by extending a dasher-actuating rod through the dispensing piston from the rear end of the cartridge thereby making the dispensing port continuously available.

The problem of enabling an operating rod initially to actuate the dasher independently of the dispensing piston and subsequently to operate the dispensing piston is solved by slidingly mounting the operating rod in the dispensing piston and by providing means to subsequently connect the operating rod directly to the dispensing piston.

In the preferred practice of the invention the subsequently operable means comprises a circumferential groove in the operating rod, a snap ring to seat in the groove and a manually operable push sleeve to shift the snap ring along the operating rod to the groove. After employing the operating rod to reciprocate the dasher for thoroughly intermixing the two ingredients, it is a simple matter to retract the operating rod to bring the dasher into abutment with the leading face of the dispensing piston and then to seat the snap ring in the groove at the rear face of the piston for fixedly connecting the piston to the operating rod.

The problem of providing the cartridge with a positively locked dispensing valve that may be quickly unlocked at the end of the mixing operation is solved by providing a valve member that protrudes through the dispensing port and is opened by axial retraction into the dispensing port. An easily removable locking collar normally embraces the protruding portion of the valve member to keep the valve member in its extended closed position. It is a simple matter to remove the locking collar to free the valve member for axial retraction to its open position.

The problem enabling the dispensing valve to open in response to the step of connecting the cartridge to the catheter is solved by making the valve member hollow and by connecting the cartridge to the catheter by telescoping the end of a connecting tube over the protruding end of the valve member. Thus with the lock removed from the dispensing valve member, the mere act of manually forcing the connecting tube over the end of .the valve member pushes the valve member rearward to its open position.

Solving the above mentioned problems relating to the operation of the dispensing cartridge also solves the problem of making it possible to connect the cartridge to the catheter in advance thereby to eliminate the need to make the connection within the allowed thirty seconds. At the end of the mixing operation it is necessary merely to pull the valve lock free and then push the dispensing cartridge slightly forward relative to the connecting tube to retract the dispensing valve member to its open position. There is no special need for making such a connection in advance of the mixing operation, however, because of the above described timesaving features of the dispensing cartridge and some operators prefer to have the dispensing cartridge disconnected from the catheter for greater freedom to perform the mixing operation.

The problem of producing the whole assembly so inexpensivelythat it may be discarded after a single use is solved largely by making both the catheter and the dispensing cartridge out of plastic parts that may be molded on a mass production basis. In addition the various parts are designed to make possible a simple assembly procedure that requires neither special skill nor special tools.

BRIEF DESCRIPTION OF THE DRAWINGS In the drawings, which are to be regarded as merely illustrative;

FIG. 1 is a longitudinal sectional view of the device showing the dispensing container connected to the catheter;

FIG. 2 is a greatly enlarged longitudinal sectional view of the catheter;

FIG. 3 is a longitudinal sectional view of the dispensing cartridge serving as a multiple compartment container prior to use of the device;

FIG. 4 is a face view of the dasher in cartridge;

FIG. 5 is an enlarged fragmentary sectional view showing the valve at the inner end of the hollow operating rod; the valve being in closed position;

FIG. 6 is a view similar to FIG. 5 showing the valve in open position;

FIG. 7 is a fragmentary longitudinal sectional view showing the operating rod retracted for the purpose of operatively connecting the operating rod to the piston;

FIG. 8 is an enlarged longitudinal sectional view of the dispensing end of the cartridge with the dispensing valve closed and locked; and

FIG. 9 is a perspective view of the clip for locking the dispensing valve in closed position.

the dispensing DESCRIPTION OF THE PREFERRED EMBODIMENT FIG. 1 illustrates the operation of injecting an uncured polymer into the rectum of a patient to mold a replica of the interior configuration of the sigmoid colon. It is obvious that a rigid molded replica could not be withdrawn from the colon whereas an exceedingly soft and flexible replica may be expelled by the patient.

The preferred embodiment of the invention shown complete in FIG. 1 comprises the combination of a catheter, generally designated 10, and a dispensing container, generally designated 12, that is releasably connected to the catheter by means of a flexible tube 14. It will be appreciated that both the catheter and the dispensing container may be of various constructions within the scope of the invention. A feature of the preferred practice of the invention is that both the catheter l0 and the dispensing container 12 are disposable for discard after a single use.

The catheter has a one-piece molded body 15 of relatively rigid plastic material, the body being of tubular configuration with an integral rearwardly flared guard flange 16. The forward end of the tubular body 15 is formed with nozzle apertures 18 and the rear end of the tubular body is telescoped into the forward end of the previously mentioned flexible tube 14. A feature of the invention is that the tubular body 15 is embraced by a resilient absorbent collar 20 forward of the guard flange 16, which collar is preferably made of a suitable open-celled foamed plastic with sponge-like characteristics. The guard flange 16 limits the extent to which the catheter may be inserted into the body cavity and the collar 20 not only serves as a cushion but also absorbs minor leakage of fluid from the body cavity during the injection procedure.

The tubular body 15 of the catheter 10 is provided with a cuff 22 of relatively thin elastomeric material which is deflated when the catheter is inserted into the body cavity and then is inflated to serve the dual purpose of preventing inadvertent withdrawal of the catheter during the injection operation and of blocking leakage of the polymer from the body cavity during the operation. For the purpose of inflating the cuff 22 when desired, a small flexible tube 24 extends from the interior of the cuff along an exterior groove 25 (FIG. 2) of the tubular body 15 and through the guard flange 16. The second end of the small tube is connected to a bulb-type hand pump 26 of a well known type, the pump being provided with a manually operable release valve 28. The catheter is inserted into the body cavity with the cuff 22 deflated and then the cuff is inflated by manual operation of the bulb-type pump. After the plastic replica cures, the release valve 28 is manipulated to deflate the cuff in preparation for withdrawal of the catheter.

Preferably the catheter 10 is covered with a smooth layer 29 of a suitable material such as latex which extends from the nozzle end of the catheter to the rim of the guard flange 16. The purpose of this layer is to provide a smooth surface for the catheter. In the construction shown the tubular body 15 of the catheter is slightly reduced in diameter to form a rearwardly circumferential shoulder 30 against which the forward edge of the layer 29 abuts in a flush manner.

In the preferred practice of the invention the catheter is provided with a small flexible vent tube 31. The forward end of the vent tube is inside the tubular body 15 near the nozzle apertures 18 and the tube extends outward through an aperture 32 of the tubular body rearward of the guard flange 16. When the uncured plastic is advanced through the flexible tube 14 into the tubular body 15 of the catheter, the air displaced by the advancing polymer escapes to the atmosphere through the vent tube 31. The vent tube 31 is of sufficiently restricted internal diameter to prevent any appreciable amount of the uncured polymer from entering the tube after the air is expelled.

The container 12 is a disposable plastic cartridge which is provided with a dispensing piston 34 for the purpose of extruding the uncured plastic into the flexible tube 14 and through the catheter 10 into the body cavity. The dispensing piston 34 is adapted to be actuated manually by a rearwardly extending operating rod that terminates in a handle or palm knob 36.

A feature of the invention is that the dispensing container 12 also serves as a multiple compartment container to store the separate ingredients of the plastic material prior to use of the device as a dispensing means. FIG. 3 shows the dispensing container or disposable cartridge 12 in the form in which it is handled and shipped prior to use.

As shown in FIG. 3 the cartridge has a cylindrical shell of suitable plastic material, the shell being reduced in diameter at the front to form a nipple 38 that provides the discharge port of the container. The rear open end of the cylindrical shell is equipped with a ring 40 having an axial opening 42 to clear the operating rod 35, the purpose of the ring being to reinforce the rear end of the shell and to serve as a stop to prevent inadvertent withdrawal of the dispensing piston 34.

As shown in FIG. 3 the dispensing piston 34 is initially in a retracted position to cooperate with the shell of the container to form a first relatively large compartment 44 for the silicone polymer. The operating rod 35 is of hollow or tubular construction to form a second smaller compartment 45 for the required catalyst. For this purpose the outer end of the tubular operating rod 35 is closed by a small slidable plug 46 which may be termed a second piston and the inner end of the tubular operating rod is normally blocked by a valve member 48 which is adapted to open in response to rise in pressure in the second compartment.

As shown in FIGS. 5 and 6, the inner end of the tubular operating rod 35 is reduced in diameter to form an outlet port 50 and a tapered inner circumferential shoulder 52 leading to the outlet port. The valve member 48 has a rear end enlargement 54 for guiding cooperation with the inner wall of the operating rod and has a forward end portion 55 which is formed with a slight circumferential enlargement 56 to seal off the outlet port 50. The valve member 48 is formed with a passage 58 through the rear enlargement 54, the passage communicating with a longitudinal recess 60 in one side of the valve member.

At the normal closed position of the valve member 48 shown in FIG. 5, the forward end portion 55 seals off the outlet port 50 of the tubular operating rod. When the second piston 46 is manually advanced in the tubular operating rod, the consequent rise in fluid pressure of the catalyst inside the operating rod causes the valve member 48 to be advanced from its retracted closed position shown in FIG. to its forward open position shown in FIG. 6. Thus manually forcing the second piston 46 forward to the region of the valve member 48 results in extrusion of the catalyst from the second compartment 45 into the first compartment 44.

The preferred embodiment of the invention includes a ram rod 62 formed with a palm knob 64 at one end, the ram rod being initially releasably tied to the dispensing container by means such as string 65. It is contemplated that the length of the ram rod 62 will be such that when the palm knob 64 abuts the palm knob 36 of the operating rod 35, the second piston 46 will reach the open valve member 48 for substantially .complete extrusion of the catalyst into the first compartment 44.

The operating rod 35 is permanently connected at its inner end to a dasher 66 which is of a suitable configuration for efficient mixing action in response to reciprocation of the dasher by the operating rod 35. As shown in FIG.4, the dasher 66 preferably has two openings 68 in two of its quadrants, the remaining half of the dasher being blank. The operating rod 35 initially slidingly extends through the dispensing piston 34 to permit reciprocation of the dasher 66 independently of the dispensing piston.

Any suitable means may be provided to fixedly connect the dispensing piston 34 to the operating rod when the time arrives for using the piston to dispense the mixed uncured polymer. In this particular embodiment of the invention the tubular operating rod 35 is provided with a circumferential groove 70 to cooperate with a split snap ring 72 and when it is desired to operate the dispensing piston 34, the snap ring is advanced from a retracted position to a position seated in the groove 70. At the seated position of the snap ring 72, the snap ring abuts the rear side of the dispensing piston and the forward side of the dispensing piston abuts the dasher 66. Thus the seated snap ring, in effect clamps the dispensing piston 34 against the dasher 66.

A feature of this embodiment of the invention is the provision of a plastic sleeve 74 which loosely embraces the operating rod 35 to serve as manual means for pushing the snap ring 72 from its restricted position to its effective seated position. FIG. 3 shows the snap ring 72 and the plastic sleeve 74 in their normal retracted positions. FIG. 7 shows the tubular operating rod 35 fully retracted to bring the dasher 66 against the front wall of the dispensing piston 34. With the operating rod 35 fully retracted in this manner, it is a simple matter to advance the plastic sleeve 74 manually from its retracted position to the position shown in solid lines in FIG. 7 for the purpose of advancing the snap ring 72 into engagement with the circumferential groove 70.

The dispensing port at the forward nipple 38 of the dispensing cartridge may be normally closed in any suitable manner. A feature of this particular embodiment of the invention is the use of a special valve member 75 for this purpose which is tubular to permit dispensing flow therethrough and which is adapted to serve as a fitting for connecting the dispensing container to the previously mentioned flexible tube 14.

completely cuts off the dispensing port and when the As best shown in FIG. 8 the dispensing valve member is closed at its inner end by a transverse wall 76, and is further provided with a radial flange 78 at itsrear end which normally abuts the inner rim of the dispensing port. The valve member 75 is further provided with a radial port 80 which is normally closed by the inner circumferential wall 82 of the dispensing port. A substantial portion of the valve member 75 protrudes forward from the dispensing port of the container and the protruding portion of the valve member is formed with a rearwardly facing circumferential shoulder 84 and a series of rearwardly inclined sharp ribs 85, which ribs serve as barbs for engagement with the inner circumferential wall of the flexible tube 14. It is.apparentin FIG. 8 that at the forward position of the valve member 75 that is shown in solid lines, the valve member valve member is retracted to the position shown in dotted lines with the shoulder 84 in abutment against the forward rim 86 of the nipple 38, the uncured plastic material may be extruded through the valve member, the plastic material flowing into the radial port 80 of the valve member.

When the dispensing container is handled, stored and shipped prior to use, the dispensing valve member 75 is locked in its forward closed position by means of a locking clip 88, the locking clip being interposed between the shoulder 84 of the valve member and the forward rim 86 of the nipple 38. As best shown in FIG. 9 the locking clip 88 has a curved body 90 dimensioned to extend more than half way around the valve member 75. The locking clip is made of sufficiently resilient plastic material to yieldingly grip the valve member in a removable manner-and the clip is formed with a ribbed tab 92 to serve as a convenient handle for removing the clip.

The manner in which the described structure serves its purpose may be readily understood from the foregoing description.

The catheter 10 with the flexible tube 14 connected thereto but separated from the dispensing container 12 is inserted into the body cavity and then the cuff 22 is inflated by means of the pump device 26. The first step in preparation for the injection operation is to reciprocate the dasher 15 for approximately fifteen full length strokes by means of the operating rod 35, stopping with the dasher approximately half way through the last stroke. When the polymer formula in the first compartment 44 stands for considerable period of time, there is a tendency for segregation of the liquid and solid ingredients and the purpose of this initial mixing action is to make the polymer homogeneous.

The next step is to use the ram rod 62 to force the second piston 46 forward in the tubular operating rod 35 thereby to move the valve member 48 to open position for extrusion of the catalyst from the second compartment 45 into the first compartment 44. The ram rod is advanced to the maximum to displace substantially all of the catalyst. The displacement of the catalyst into the first compartment 44 starts the time period of 30 seconds during which the two ingredients of the uncured plastic must be thoroughly intermixed. After this 30-second time interval the extrusion of the mixed plastic into the body cavity must be completed within an additional time interval of seconds before the plastic starts to cure. Thorough intermixture of the two ingredients is required and is accomplished by reciprocating the operating rod 35 for its full length approximately times. The introduction of the catalyst into the first compartment 44 causes the dispensing piston 34 to retract slightly on the first stroke of the operating rod.

The mixing operation is terminated with the operating rod 35 fully retracted and then the plastic sleeve 74 is advanced from the position shown in FIG. 3 to the position shown in FIG. 7 for the purpose of shifting and seating the snap ring 72 to anchor the dispensing piston 34 to the operating rod.

The next step is to grasp the tab 92 of the locking clip 88 to remove the locking clip and thus free the dispensing valve 75. With the locking clip removed, the

barbed end of the dispensing valve 74 is inserted into the end of the flexible tube 14. This act of forcing the dispensing valve member 75 into the tube 14 causes retraction of the dispensing valve to its open position in reaction to the applied force. Thus the operator is not required to take time to open the dispensing valve. With the dispensing valve open, the operator advances the dispensing piston 34 to the maximum by means of the operating rod 35 to extrude the uncured plastic through the flexible tube 14 and through the catheter 10 into the body cavity. After a short time, the release valve 28 of the bulb pump 26 may be opened for deflation of the cuff 22 to permit withdrawal of the catheter.

Our description in specific detail of the preferred embodiment of the invention will suggest various changes, substitutions and other departuresvfrom our disclosure within the spirit and scope of the appended claims.

We claim:

1. In a medical device of the character described for injecting an uncured fluent plastic material into a cavity of a patients body to be cured therein to form a soft resiliently flexible molded replica of the configuration of the interior of the cavity, the combination of:

A a catheter for insertion into the cavity, said catheter including an injection nozzle for introduction of the uncured plastic;

a guard flange fixedly united with the catheter to limit the insertion of the injection nozzle;

an absorbent collar embracing the catheter forward of the guard flange for confinement between the guard flange and the patients body when the catheter is inserted into the cavity, said collar being made of a soft porous material to serve as a cushion and to absorb and retain fluids released from the cavity after the catheter is inserted and during the injection operation; and

means to release to the atmosphere air that is displaced into the catheter by the flow of plastic to the catheter thereby to prevent the displaced air from causing a misleading void in the molded replica.

2. In a medical device of the character described for injecting an uncured fluent plastic into a cavity of a patients body to be cured therein to form a soft resiliently flexible molded replica of the configuration of the interior of the cavity, the combination of:

a catheter for insertion into the cavity, said catheter including an injection nozzle for introduction of the uncured plastic;

means including a passage means to deliver uncured 5 plastic to the catheter;

a hollow cuff embracing the catheter rearward of the tip of the nozzle for inflation to close off the body cavity back of the nozzle during the injection operation; and

means to release to the atmosphere air that is displaced from said passage means into the catheter by the advance of the plastic through the supply passage thereby to avoid entrapment of such displaced air in the cavity as would prevent the plastic from filling the cavity.

3. A combination as set forth in claim 2 in which said means to release air has a flow passage of restricted cross section toprevent significant diversion of the uncured plastic into the flow passage.

4. A combination as set forth in claim 2 which includes a passage means connected to the catheter and a cartridge connected at its front end to the passage means,

said cartridge having a plurality of separate compartments to store separate ingredients of the uncured plastic,

said cartridge including a dasher operable from the rear end of the cartridge to intermix the ingredients to form the uncured plastic,

said cartridge including means to extrude the uncured plastic into the passage means.

5. A combination as set forth in claim 2 in which said catheter hasa guard rearward of the nozzle tip fixedly secured thereto to limit insertion of the catheter into the body cavity; and

in which said releasing means extends through the guard to the region rearwardly thereof.

6. A combination as' set forth in claim 5 which includes an absorbent collar embracing the catheter forward of the guard for confinement between the guard and a patients body when the catheter is inserted into the cavity,

said collar being made of a soft porous material to serve as a cushion and to absorb and retain fluid released from the body cavity after the catheter is inserted and during the injection operation.

7. A combination as set forth in claim 5 in which said catheter, hollow cuff and guard are covered by a layer of plastic material forming a smooth surface that is continuous from the region of the tip of the injection nozzle to the rim of the guard.

8. A combination as set forth in claim 2 which includes a cartridge connected at its forward end to the catheter to deliver uncured plastic thereto,

said cartridge including a dasher manually operable from the rear end of the cartridge to intermix the ingredients to form the uncured plastic,

said cartridge including manually operable means to extrude the uncured plastic into the catheter.

9. Means for intermixing a plurality of ingredients and then promptly dispensing the mixture, comprising:

said manually releasable means is a removable locking member in engagement both with the dispensing container and with the valve member to hold the valve member in closed position.

said valve member has a peripheral rearwardly facing shoulder and said container forms a forwardly facing shoulder;

, said valve means being in the form of a tubular valve 1 member slidingly telescoped into the dispensing port to control flow therethrough,

said tubular valve member protruding from the dispensing port to form a dispensing nozzle capable-of attachment to a flexible tube by insertion of the valve member into the end of the tube,

said tubular valve member being axially retractable from a forward closed position to a rearward open position.

10. A combination as set forth in claim 9 which ineludes manually releasable means to retain the valve member normally at its forward closed position.

11. A combination as set forth in claim 10 in which 12. A combination as set forth in claim ll in which and then promptly dispensing the mixture, comprising:

a dispensing container having a forward end and-a rearward end with a normally closed dispensing port inthe forward end;

a dispensing piston in said dispensing container defining therewith a first ingredient-containing compartment in communication with the dispensing port;

a dasher in said first compartment;

a manually operable rod extending from the dasher through the piston to the rear end of the dispensing container to actuate the dasher independently of the piston,

said rod being hollow to form a second ingredientcontaining compartment;

means operable from the rear end of the operating rod to extrude the content of said second compartment into the first compartment; and

manual means to operatively connect the piston to the rod member for actuation of the piston by the rod member to extrude the mixed ingredients from the first compartment through the dispensing port.

14. A combination as set forth in claim 13 which ineludes:

a normally closed valve at the inner end of the hollow rod, said valve being responsive to pressure in thehollow rod to open in response to rise in the pressure; and

a second piston normally closing the outer end of the hollow rod, whereby said second piston may be manually advanced towardssaid pressure-responsive valve to create pressure within the hollow' rod member to open the pressure-responsive valve and then to displace the content of the second compartment into the first compartment.

15. Means for intermixing at least two ingredients and then dispensing the mixture, comprising:

a container having compartments to store the ingredients separately, said container having a forward dispensing port and having a rearward piston serving as a rear wall for one of the compartments;

means to place the compartments in communication with each other to bring the ingredients into mu tual contact;

a dasher to intermix the mutually contacting ingredients; Y

a manually operable rod slidingly extending through the rearward piston to reciprocate said dasher; and

manually operable means to connect the piston to the rod for actuation of the piston by the rod to extrude the mixed ingredients from the container through the dispensing port,

said means to operatively connect the rod to the piston comprising:

shoulder means on the periphery of the rod;

and a cooperative retainer element outside of the container slidingly mounted on the rod and normally spaced from said shoulder means,

said retainer element being manually movable into engagement both with said shoulder means and with the piston'for the purpose of operatively connecting the piston to the rod.

16. A combination as set forth in claim 15 in which said retainer element is slidingly mounted on the rod and which includes a sleeve slidingly embracing the rod to serve as manual means for pushing the retainer element from its normal position to a position in engagement with said shoulder means.

17. A combination as set forth in claim 15 in which said shoulder means comprises a circumferential groove on the periphery of the rod and said retainer element is a snap ring slidingly embracing the rod.

18. A combination as set forth in claim 17 which includes a sleeve slidingly embracing the rod, said sleeve being manually operable to push said snap ring into said circumferential groove.

19. In a medical device of the character described for injecting an uncured fluent plastic material into a cavity of a patients body to be cured therein to form a soft resiliently flexible molded replica of the configuration of the interior of the cavity, the combination of:

a dispensing container having a forward dispensing port connected to said catheter;

said container having multiple compartments for multiple ingredients of the mixture;

means operable from the rear end of the dispensing container to bring said ingredients together;

a dasher operable from the rear end of the dispensing container to intermix the ingredients;

manual means operable from the rear end of the dispensing container to extrude the ingredients manually through said dispensing port; and

means to prevent extrusion from the dispensing container while the dispensing container is connected to the catheter when the dasher is in operation.

20. In a medical device of the character described for injecting an uncured fluent plastic material into a cavity of a patients body to be cured therein to form a soft resiliently flexible molded replica of the configuration of the interior of the cavity, the combination of:

a dispensing container having a forward end with a dispensing port for connection with the catheter;

a dasher in said first compartment;

said rod being hollow to form a second ingredientcontaining compartment;

21. In a device for injecting an uncured plastic into a cavity to form therein a replica of the cavity that is sufficiently resiliently deformable to permit withdrawal of the replica without destroying the configuration of the replica, the combination of:

a catheter for insertion into the cavity;

a dispensing container having a forward end and a rearward end with a dispensing port in the forward end;

said container having multiple compartments for multiple ingredients of the plastic;

means operable from the rear end of the dispensing container to intermix the ingredients;

means operable from the rear end of the dispensing container to extrude the ingredients through said dispensing port;

a hollow valve member slidingly mounted in the dispensing port and protruding axially from the dispensing port to serve as a dispensing nozzle; and

a flexible tube having one end telescoped over said hollow valve member and having its other end connected to the catheter to place the dispensing container in flow communication with the catheter,

said hollow valve member being axially retractable from a forward closed position to a rearward open position,

whereby manually telescoping the end of the tube over the hollow valve member involves applying axial force to the valve member to retract the valve member to its open position.

22. In a medical device of the character described for injecting an uncured fluent plastic into a cavity of a pateients body to be cured therein to form a soft resiliently flexible molded replica of the configuration of the interior of the cavity which includes a catheter for insertion into the cavity and means to extrude the fluent plastic into the cavity through the catheter,

the improvement comprising:

means to release to the atmosphere air that is displaced from the interior of the catheter by initial.

advance of the extruded plastic thereby to 'avoid forcing the displaced air into the cavity and consequent failure of the plastic to substantially completely fill the cavity.

23. In a method of diagnosing the condition of a cavity of a living person wherein a catheter with a passage therethrough is inserted into the cavity and uncured plastic material is extruded through said passage into the cavity to result in a soft resilient flexible replica of the configuration of the interior of the cavity, and wherein escape of the plastic material from the cavity along the outer surface of the catheter is blocked,

the'improvement comprising:

venting air from said passage of the catheter to the atmosphere as the plastic material progressively occupies the passage thereby to prevent the air from being forced into the cavity with consequent failure of the plastic material to substantially completely fill the cavity.

24. In a medical device of the character described for injecting an uncured fluent plastic into a cavity of a patients body to be cured therein to form a soft resiliently flexible molded replica of the configuration of the interior of the cavity, the combination of:

a catheter for insertion into the cavity for injection the uncured plastic into the cavity through the catheter;

a hollow cuff embracing the catheter rearward of the leading end of the catheter for inflation to close off the body cavity back of the leading end of the catheter during the injection operation;

a cartridge containing a supply body of the uncured plastic,

said cartridge having a dispensing port;

a tubular valve member in the dispensing port protruding therefrom to serve as a nozzle for the cartridge;

a flexible tube connecting the tubular valve member to the catheter, the upstream end of the tube being telescoped over the tubular valve member,

the tubular valve member being retractable from a forward closed position to a rearward open position whereby manually telescoping the upstream end of the tube over the protruding end of the tubular valve member involves applying axial force to the valve member to retract the valve member to its open position;

means to extrude the uncured plastic from the container to the catheter through said dispensing port, said tubular valve member and through the flexible tube; and

a vent tube placing the interior of the catheter near its leading end in communication with the 'atlO60l2 0041

Claims

1. In a medical device of the character described for injecting an uncured fluent plastic material into a cavity of a patient''s body to be cured therein to form a soft resiliently flexible molded replica of the configuration of the interior of the cavity, the combination of: a catheter for insertion into the cavity, said catheter including an injection nozzle for introduction of the uncured plastic; a guard flange fixedly united with the catheter to limit the insertion of the injection nozzle; an absorbent collar embracing the catheter forward of the guard flange for confinement between the guard flange and the patient''s body when the catheter is inserted into the cavity, said collar being made of a soft porous material to serve as a cushion and to absorb and retain fluids released from the cavity after the catheter is inserted and during the injection operation; and means to release to the atmosphere air that is displaced into the catheter by the flow of plastic to the catheter thereby to prevent the displaced air from causing a misleading void in the molded replica.

2. In a medical device of the character described for injecting an uncured fluent plastic into a cavity of a patient''s body to be cured therein to form a soft resiliently flexible molded replica of the configuration of the interior of the cavity, the combination of: a catheter for insertion into the cavity, said catheter including an injection nozzle for introduction of the uncured plastic; means including a passage means to deliver uncured plastic to the catheter; a hollow cuff embracing the catheter rearward of the tip of the nozzle for inflation to close off the body cavity back of the nozzle during the injection operation; and means to release to the atmosphere air that is displaced from said passage means into the catheter by the advance of the plastic through the supply passage thereby to avoid entrApment of such displaced air in the cavity as would prevent the plastic from filling the cavity.

3. A combination as set forth in claim 2 in which said means to release air has a flow passage of restricted cross section to prevent significant diversion of the uncured plastic into the flow passage.

4. A combination as set forth in claim 2 which includes a passage means connected to the catheter and a cartridge connected at its front end to the passage means, said cartridge having a plurality of separate compartments to store separate ingredients of the uncured plastic, said cartridge including a dasher operable from the rear end of the cartridge to intermix the ingredients to form the uncured plastic, said cartridge including means to extrude the uncured plastic into the passage means.

5. A combination as set forth in claim 2 in which said catheter has a guard rearward of the nozzle tip fixedly secured thereto to limit insertion of the catheter into the body cavity; and in which said releasing means extends through the guard to the region rearwardly thereof.

6. A combination as set forth in claim 5 which includes an absorbent collar embracing the catheter forward of the guard for confinement between the guard and a patient''s body when the catheter is inserted into the cavity, said collar being made of a soft porous material to serve as a cushion and to absorb and retain fluid released from the body cavity after the catheter is inserted and during the injection operation.

8. A combination as set forth in claim 2 which includes a cartridge connected at its forward end to the catheter to deliver uncured plastic thereto, said cartridge having a plurality of separate compartments to store separate ingredients of the uncured plastic, said cartridge including a dasher manually operable from the rear end of the cartridge to intermix the ingredients to form the uncured plastic, said cartridge including manually operable means to extrude the uncured plastic into the catheter.

9. Means for intermixing a plurality of ingredients and then promptly dispensing the mixture, comprising: a dispensing container having a forward end and a rearward end with a normally closed dispensing port in the forward end, said container having multiple compartments for multiple ingredients of the mixture; means operable from the rear end of the dispensing container to bring said ingredients together; dasher means operable from the rear end of the dispensing container to intermix the ingredients; means operable from the rear end of the dispensing container to extrude the ingredients through said dispensing port; and valve means normally closing said dispensing port, said valve means being in the form of a tubular valve member slidingly telescoped into the dispensing port to control flow therethrough, said tubular valve member protruding from the dispensing port to form a dispensing nozzle capable of attachment to a flexible tube by insertion of the valve member into the end of the tube, said tubular valve member being axially retractable from a forward closed position to a rearward open position.

10. A combination as set forth in claim 9 which includes manually releasable means to retain the valve member normally at its forward closed position.

11. A combination as set forth in claim 10 in which said manually releasable means is a removable locking member in engagement both with the dispensing container and with the valve member to hold the valve member in closed position.

12. A combination as set forth in claim 11 in which said valve member has a peripheral rearwardly facing shoulder and said container forms a forwardly facing shoulder; AND in which said locking member is a U-shaped member to releasably embrace the valve member with opposite sides of the U-shaped member in abutment with said two shoulders respectively.

13. Means for intermixing a plurality of ingredients and then promptly dispensing the mixture, comprising: a dispensing container having a forward end and a rearward end with a normally closed dispensing port in the forward end; a dispensing piston in said dispensing container defining therewith a first ingredient-containing compartment in communication with the dispensing port; a dasher in said first compartment; a manually operable rod extending from the dasher through the piston to the rear end of the dispensing container to actuate the dasher independently of the piston, said rod being hollow to form a second ingredient-containing compartment; means operable from the rear end of the operating rod to extrude the content of said second compartment into the first compartment; and manual means to operatively connect the piston to the rod member for actuation of the piston by the rod member to extrude the mixed ingredients from the first compartment through the dispensing port.

14. A combination as set forth in claim 13 which includes: a normally closed valve at the inner end of the hollow rod, said valve being responsive to pressure in the hollow rod to open in response to rise in the pressure; and a second piston normally closing the outer end of the hollow rod, whereby said second piston may be manually advanced towards said pressure-responsive valve to create pressure within the hollow rod member to open the pressure-responsive valve and then to displace the content of the second compartment into the first compartment.

15. Means for intermixing at least two ingredients and then dispensing the mixture, comprising: a container having compartments to store the ingredients separately, said container having a forward dispensing port and having a rearward piston serving as a rear wall for one of the compartments; means to place the compartments in communication with each other to bring the ingredients into mutual contact; a dasher to intermix the mutually contacting ingredients; a manually operable rod slidingly extending through the rearward piston to reciprocate said dasher; and manually operable means to connect the piston to the rod for actuation of the piston by the rod to extrude the mixed ingredients from the container through the dispensing port, said means to operatively connect the rod to the piston comprising: shoulder means on the periphery of the rod; and a cooperative retainer element outside of the container slidingly mounted on the rod and normally spaced from said shoulder means, said retainer element being manually movable into engagement both with said shoulder means and with the piston for the purpose of operatively connecting the piston to the rod.

19. In a medical device of the character described for injecting an uncured fluent plastic material into a cavity of a patient''s body to be cured therein to form a soft resiliently flexible molded replica of the configuration of the interior of the cavity, the combination of: a catheter for insertion into the cavity, said catheter including an injection nozzle for introduction of the uncured plastic; a dispensing container having a forward dispensing port connected to said catheter; said container having multiple compartments for multiple ingredients of the mixture; means operable from the rear end of the dispensing container to bring said ingredients together; a dasher operable from the rear end of the dispensing container to intermix the ingredients; manual means operable from the rear end of the dispensing container to extrude the ingredients manually through said dispensing port; and means to prevent extrusion from the dispensing container while the dispensing container is connected to the catheter when the dasher is in operation.

20. In a medical device of the character described for injecting an uncured fluent plastic material into a cavity of a patient''s body to be cured therein to form a soft resiliently flexible molded replica of the configuration of the interior of the cavity, the combination of: a catheter for insertion into the cavity, said catheter including an injection nozzle for introduction of the uncured plastic; a dispensing container having a forward end with a dispensing port for connection with the catheter; a dispensing piston in said dispensing container defining therewith a first ingredient-containing compartment in communication with the dispensing port; a dasher in said first compartment; a manually operable rod extending from the dasher through the piston to the rear end of the dispensing container to actuate the dasher independently of the piston, said rod being hollow to form a second ingredient-containing compartment; means operable from the rear end of the operating rod to extrude the content of said second compartment into the first compartment; and manual means to operatively connect the piston to the rod member for actuation of the piston by the rod member to extrude the mixed ingredients from the first compartment through the dispensing port.

21. In a device for injecting an uncured plastic into a cavity to form therein a replica of the cavity that is sufficiently resiliently deformable to permit withdrawal of the replica without destroying the configuration of the replica, the combination of: a catheter for insertion into the cavity; a dispensing container having a forward end and a rearward end with a dispensing port in the forward end; said container having multiple compartments for multiple ingredients of the plastic; means operable from the rear end of the dispensing container to bring said ingredients together; means operable from the rear end of the dispensing container to intermix the ingredients; means operable from the rear end of the dispensing container to extrude the ingredients through said dispensing port; a hollow valve member slidingly mounted in the dispensing port and protruding axially from the dispensing port to serve as a dispensing nozzle; and a flexible tube having one end telescoped over said hollow valve member and having its other end connected to the catheter to place the dispensing container in flow communication with the catheter, said hollow valve member being axially retractable from a forward closed position to a rearward open position, whereby manually telescoping the end of the tube over the hollow valve member involves applying axial force to the valve member to retract the valve member to its open position.

22. In a medical device of the character described for injecting an uncured fluent plastic into a cavity of a pateient''s body to be cured therein to form a soft resiliently flexible molded replica of the configuration of the interior of the cavity which includes a catheter for insertion into the cavity and means to extrude the fluent plastic into the cavity through the catheter, the improvement comprising: means to release to the atmosphere air that is displaced from the Interior of the catheter by initial advance of the extruded plastic thereby to avoid forcing the displaced air into the cavity and consequent failure of the plastic to substantially completely fill the cavity.

23. In a method of diagnosing the condition of a cavity of a living person wherein a catheter with a passage therethrough is inserted into the cavity and uncured plastic material is extruded through said passage into the cavity to result in a soft resilient flexible replica of the configuration of the interior of the cavity, and wherein escape of the plastic material from the cavity along the outer surface of the catheter is blocked, the improvement comprising: venting air from said passage of the catheter to the atmosphere as the plastic material progressively occupies the passage thereby to prevent the air from being forced into the cavity with consequent failure of the plastic material to substantially completely fill the cavity.

24. In a medical device of the character described for injecting an uncured fluent plastic into a cavity of a patient''s body to be cured therein to form a soft resiliently flexible molded replica of the configuration of the interior of the cavity, the combination of: a catheter for insertion into the cavity for injection the uncured plastic into the cavity through the catheter; a hollow cuff embracing the catheter rearward of the leading end of the catheter for inflation to close off the body cavity back of the leading end of the catheter during the injection operation; a cartridge containing a supply body of the uncured plastic, said cartridge having a dispensing port; a tubular valve member in the dispensing port protruding therefrom to serve as a nozzle for the cartridge; a flexible tube connecting the tubular valve member to the catheter, the upstream end of the tube being telescoped over the tubular valve member, the tubular valve member being retractable from a forward closed position to a rearward open position whereby manually telescoping the upstream end of the tube over the protruding end of the tubular valve member involves applying axial force to the valve member to retract the valve member to its open position; means to extrude the uncured plastic from the container to the catheter through said dispensing port, said tubular valve member and through the flexible tube; and a vent tube placing the interior of the catheter near its leading end in communication with the atmosphere to release to the atmosphere air that is displaced from said flexible tube by the advance of the plastic through the flexible tube thereby to avoid such entrapment of displacement air in the cavity as would keep the plastic from substantially filling the cavity.