MXPA99004100A - Apparatus and process for forming prosthesis socket - Google Patents

Abstract

A prosthesis socket casting device (10) includes a base member (12) on which an elongated annular molding bladder (28) is mounted, the bladder (28) peripherally enclosing a centrally located casting area (38) and extendable when inflated from the forward side (14) of the base (12). The bladder (28) is formed of a pliable, air impermeable, relatively non-stretchable sheet material enclosing, in cooperation with the base (12), an air chamber peripherically surrounding the casting area (38). The casting area (38) includes an open residual limb receiving end (40) and extends from such end (40) to the base (12), and an inflation system for the bladder (28) is provided. The casting device (10) may be used in conjuction with a prosthesis suction socket that includes a tension member at its distal end connectable to the base member (12) during a casting procedure. The bladder (28) is rollable relative to the base member (12) to provide ready access to the tension member connector carried by the base member (12).

Description

APPARATUS AND PROCESS TO FORM AN ADAPTER CAP FOR PROSTHESIS FIELD OF THE INVENTION This invention relates to an apparatus and method for forming or molding adapter sleeves for prostheses or prosthetics on remaining limbs or limbs.

BACKGROUND OF THE INVENTION The adapter sleeves for remaining limbs or limbs are formed in accordance with the prior art using various apparatus and methods, including thermoforming by molding, thermoforming or other resinous materials to obtain a relatively rigid adapter socket for connecting a limb or remaining limb to a device of prosthesis without discomfort for the user. Such adapter sleeves molded without and with reinforcements or reinforcements are exemplified in U.S. Patent Nos. 5,163,965, concessioned on November 17, 1992, to Rasson and Fischel; and 5,263,990, concessioned on November 23, 1993, to Handal. The techniques of the previous method include molding adapter sleeves of resinous materials using a male or positive mold of the remaining member which is formed from a female mold mold of paris or negative mold sleeve which has been formed by molding the sleeve directly on the remaining member. It is also known to form the ultimate adapter sleeve using a pressure molding system exemplified by the ICECAST® system made by Ossur HF of Reykjavik, Iceland. The positive mold was then adjusted or "rectified" in accordance with well-known techniques to provide relief for the sensitive areas of the remaining member and obtain a correctly dimensioned adapter sleeve that could fit appropriately to the remaining limb or limb. Other methods for the provisional or final molding of adapter sleeves have been described in the prior art, including a procedure whereby the SCOTCHCAST® tape made by 3M Company of Minneapolis, Minnesota, has been used to produce an adapter sleeve for temporary prosthesis. for amputations below the knee The existence of devices to form adapter sleeves for prostheses on remaining limbs tend to be bulky and sometimes complex. It is desirable to provide a compact, simplified and compact prosthesis or prosthesis socket forming or forming system, which not only facilitates the molding or press forming of casting material or prosthesis adapter sleeves directly over the area of the remote end of a prosthesis. remaining member but also makes it possible to apply tension to the extreme area away from the remaining member during the melting process to produce a better fixing cap.

BRIEF DESCRIPTION OF THE INVENTION The present invention is a device for molding the adapter sleeve for prosthesis or prosthesis formed from a base on which it mounts an elongated annular molding bag peripherally enclosing a molding area generally centrally located, extendable from the base over a length of the bag. Preferably, the bag comprises a relatively non-stretchable, air-impermeable, foldable sheet material that includes, in cooperation with the base member, an air chamber peripherally surrounding the molding area when the bag extends away from the front side of the base and is at least partially inflated to tighten the material of the bag. The base preferably bears a tension element connector for coupling a tension member associated with a suction sleeve previously mounted on the end area remote from a remaining member on which a prosthesis adapter sleeve is molded. The base also includes a passage of air in communication with the air chamber of the bag and a valve in the passage of the arranged air to control the flow of air through the passage. A sleeve material of the adapter sleeve for moldable and fixable prosthesis (which can be any moldable and settable material, including plasticizer from Paris) is placed on a suction sleeve having a tension element or guide pin extending through the material of the prosthesis socket in engagement with the tension connector made by the base or simply extending into the base as a centering guide. The prosthesis sleeve optionally includes a prosthetic device coupler at its remote end that can be part of the prosthesis sleeve and ultimately the prosthesis adapter sleeve. The material of the prosthesis cap is fusible and moldable on the remaining member but it does not cure when it is first placed on the suction cap and the extremity. The extension over and inflation of the bag in the area remote from the remaining limb in which the moldable prosthesis sleeve material and the suction sleeve have been previously placed to allow compression of the remote area of the remaining member including the material of the prosthesis sleeve while the material of the prosthesis sleeve undergoes curing and fixation or hardening to a relatively rigid structural form. However, due to the geometry of the pouch and the configuration of the area remote from the remaining member, the suction cap and the molding material of the cap for the prosthesis, a resultant tensile force between the base element and the suction sleeve it is generated and transmitted to a tension element when they are used and when the bag is inflated to compress the area of the end remote from the remaining member with the suction cap and the molding material of the prosthesis socket. This tensile force results in elongation of the area away from the remaining limb or limb during compression thereof by the bag and is proportional to the inflation pressure of the bag and other variables. The combination of compressive and tension forces on the area remote from the remaining member produces an adapter sleeve for prosthesis from the socket material after curing the latter, which is comfortable for the user without substantial additional adjustment of the socket. The cap material may include suitable inner and outer cover of fabric to make the cap comfortable when worn and for cosmetic purposes. The invention includes a hand pump that can be attached or attached to the base element to pressurize the bag where both the base element and the hand pump can be connected together by a coupling and snap-in / quick-release fastener or fastener that opens a Check valve normally closed in the air passage communicating with the inside of the bag so that the bag can be supplied with pressurized air from the pump when the pump and the base element are connected together. The valve blocks otherwise the air outlet from the bag. The bag can be formed of a continuous tubular element bent backwards on it to produce two tubular sections, one inside the other, the free ends of which are connected in sealing relationship to the base element. An air chamber is thus produced between the internal and external tubular sections connected to the base element and the air chamber is in communication with an air passage in the base element. The bag can be formed of a silicone rubber material into which a cloth or fiber reinforcement is embedded which makes the fabric relatively non-extensible while leaving it highly elastic and flexible so that it follows the outline of a remaining member in the fabric. molding area located within the inner tubular section of the bag. The bag can be conveniently wound in and back relative to the base member when it is partially inflated so as to expose the front side of the base element to a tension element that can be associated with the suction socket. A release mechanism and a tension element connector, if used, it is also accessible from the front side of the base element when the bag is wound backwards relative to the base element. Rolling the bag forward over the end area away from a residual limb in which a suction cap and prosthesis material have been placed, wraps the prosthesis material and propels the material in close conformance with the remote end area of the remaining member, particularly after the bag has been inflated to a selected pressure to cause compression-forming or molding of the prosthesis adapter cap material during its curing process.

As previously noted, this compressive force also produces a close tension or tensile force exerted on the tension element that elongates and tightens the area away from the residual limb or limb during the compression molding process to produce a prosthesis cap. better adjustment from the curing of the bushing sleeve material.

Optionally, the tension element and the tension connector element can be altered so that simple compression molding can be performed without tensile or tensile force applied to the suction socket.

The molding material of the prosthesis sleeve is preferably constituted by a reinforcing matrix impregnated with water-curable resinous material which is prepared as a preformed rolled sleeve or cover which can easily be given over the area remote from the remaining member. Various combinations of resin reinforcement can be used and a specific preferred material is described in more detail below.

BRIEF DESCRIPTION OF THE DRAWINGS Figure 1 is a section elevation view showing a device for molding caps for prostheses constructed in accordance with the present invention and in particular the ring molding bag carried by a base element which includes in this embodiment a connector of the element of releasable tension and an air duct for admitting and releasing air in and from an air chamber in the molding bag; Figure 2 shows a detail of the silicone bag material illustrating reinforcing fibers used in the material; Figure 3 is a sectional view taken along the line III-III of Figure 2; Figure 4 shows an air pump usable with the molding bag assembly for inflating the bag and also for providing a tension reading and sensor device and a pressure gauge associated with the pump; Figures 5 and 6 show the molding bag during inflation of the bag; Figure 7 shows the bag wound back from the base with the pump connected to the base; Figure 8 shows a suction cap used on a remaining member with a tension connector extending from the far end of the suction sleeve connected to the base, and a moldable and adjustable prosthesis material with a prosthesis coupler mounted on the suction sleeve between the suction sleeve and the base; Figures 9 and 10 show the bag progressively rolled forward relative to the base on the silicone sleeve and moldable prosthesis material with the bag in the partially inflated condition. Figure 11 shows the molding device of the prosthesis cap of the invention with the bag in the fully inflated condition that exerts compression on the remote area of the remaining limb, prosthesis material and suction cap and with a tension force applied to the element of tension through the base due to the reaction forces resulting from the relationship between the inflated bag, the remaining limb or limb, the suction sleeve and the prosthesis material; Figure 12 is a sectional view showing details of the base, suction sleeve, material for prosthesis and coupler for prosthesis, tension element and a connector of the associated releasable tension element carried by the base as well as the connection of the molding bag to the base and details of the duct valve / air check; Figure 13 shows an alternate form of the bag; and Figure 14 shows an alternate form of the suction socket connector and the base element.

DETAILED DESCRIPTION OF THE PREFERRED MODALITY (S) (S) With reference to the drawings, a device for molding an ter sleeve for a prosthesis 10 according to a preferred form of the invention includes a base element 12 having a front side 14 and a side 16. The base member 12 also preferably includes an air passage 18 which extends rearwardly of the rear side 16 but which is normally enclosed by a check valve of the spring-biased ball type 20 which maintains the passage of the closed air for exhausting air outwardly through the rear side 16 of a base member 12. A quick-engaging / releasing coupling 22 of the air passage allows to fix or adjust a pump element (to be described later) to the base member 12 to open the check valve 20 and admit selectively pressurized air into the conduit 18. The base member 12 also includes a connector of the releasable tension element 24 constituting a spring-deflected open plate that couples a tension element similar to a pin or pivot (to be described later) during the pressurized molding of an adapter sleeve for prostheses on the remote area of a limb shelf. An opening 26 on the forward side of the base member 12 provides access to the connector of the tension element 24 from a molding chamber defined by an inflatable annular molding bag 28 connected to the front side of the base element 12. The molded bag 28 it is preferably formed of silicone rubber reinforced by a weft or strands of material that is or are relatively non-extensible when compared to the rubber material of the bag. Figures 2 and 3 depict the bag material 30 formed of a flexible and elastic silicone rubber sheet, for example, or any other material that makes up the main and flexible element, with a weft or strands of reinforcing material or reinforcement 32 embedded in the silicon rubber to make the material of the bag relatively non-extensible in both radial and longitudinal directions . Essentially, the material of the bag is configured and formed so as to provide an inflatable bag that does not extend beyond a fixed total volume that will be defined by the material of the bag and, in accordance with the preferred embodiment, the base 12. In the preferred embodiment, the bag material 30 is formed of a single tube of bag material similar to the sheet or sheet, folded back on itself to form a continuous tubular bag having internal and external tube sections as shown in FIG. illustrates, with the free ends of the tubular element sealably anchored to the base element 12. In accordance with the preferred embodiment, the inner section 34 of the tubular element bent backwards may have a lower final diameter than the outer section 36 and both ends may be securing to the front side of the base element 12. Alternatively, the free ends of the tubular element having sections 34, 36 can be configured as They are connected in a sealed manner to the base element 12 in an appropriate manner. A preferred embodiment of securing the free ends of the tubular sections 34, 36 to the base element 12 can be seen in Figure 12c, to be described in greater detail later.

Alternatively, the tubular sections 34, 36 can be formed of internal and external tubular elements formed of similar but relatively non-extensible flexibility material wherein the inner ends of the tubular elements are sealedly connected to the base 12 and the outer ends of the tubular elements are connected in a sealable manner together to their ends opposite the base 12 as shown in Figure 13. Clearly, any arrangement suitable to provide an inflatable bag that will define a molding area to be described momentarily, can be use for the bag element 28. The essential feature of the bag 28 is that it is formed of a material that does not extend itself substantially when it is tensioned, yet the bag will be fully flexible when inflated to wrap a limb or limb remaining located within the section of the inner tube 34, which is intended to constitute an area of molding of generally centered bushes 38. The molding area 38 within the section of the inner tube 34 extends from the opening 26 located on the front side of the base 12 forward to a receiving opening 40 of the remaining open member that can be moved with respect to the base 12 in a manner as described below in relation to Figures 7-10. The cross-sectional area and the total volume of the molding area 38 when filled is intended to be less than the cross-sectional area and the volume of an area remote from the remaining limb or limb, suction cap and adapter cap material. for prosthesis placed within the molding area of a prosthesis adapter sleeve, which has been described momentarily. That is, when the bag 28 is inflated at sufficient pressure to place the bag material under tension, the total volume of the molding area 38 will be less than the volume of an area remote from the remaining member, a suction cap placed on the bag. remote area of the remaining member and material of the prosthesis adapter sleeve to be molded in place in the area remote from the remaining limb or limb. Preferably, a hand pump 42 illustrated in Figure 4 can be provided to selectively pressurize the bag 28. The pump 42 includes a quick-release / engagement adjustment device 44 of the pump at its forward end to be attached to the device. coupling 22 quick release / coupling of the air passage associated with the air passage 18 in the base element 12. Such couplings and quick release / engagement adjustments are well known to the person skilled in the art and do not constitute per se a part of the present invention. Any suitable coupling or quick release attachment can be used to achieve the function of removable coupling of the pump 42 to the base member 12 to selectively supply pressurized air to the air passage 18 and the bag 28. Alternatively, for its post, any suitable air passage or air supplying pump could be used, for example a direct air supply fixing or adjusting device (not shown) on the bag itself, similar to used fixing or adjusting devices on pneumatic bands, toys and inflated balls. The pump 42 may include a manually operated double-acting piston 46 slidable along an elongated cylinder 48 to release the pressurized air from the outside piston 46 via conduits 50, 52, 54 to the interior of the cylinder 48 and finally to the passage of air 18 via a check valve 20. In accordance with known engagement / release couplings, the setting 44 of the pump 42 will be arranged to move the normally closed ball check valve 20 to an open position to allow the pressurized air is introduced into the bag 28 under the action of the pump 42. However,, the pump 42 will preferably maintain the pressure of the air that is inside the air chamber of the bag. The pump 42 may include a voltage indicator at 56, a pressure release valve 58 and a pressure indicator 60 to indicate static pressure in the bag 28 when the pump 42 is connected to the base 12. The release valve of pressure 58, obviously, is provided to release or discharge in a controllable manner the air pressure from inside the bag 28 in a selected manner. Figure 5 shows the pump 42 connected to the base 12 with the bag 28 in the relatively relaxed condition while extending inward from the front side or side of the base 12. The manipulation of the pump 42 makes it possible to inflate the bag 28 as shown in Figure 6, where the check valve 20 is shown in the open position and the pressurized air from the pump 42 is released or supplied to the interior of the bag 28 via the air passage 18. It will be observed that the molding area 38 centrally located within the interior of the bag 28 compares relatively little with the overall size of the bag and can be configured in any desirable shape or configuration to accommodate a molding operation to be described later. As illustrated in Figures 7 and 8, to allow access to the opening 26 and the connector of the tension element 24 located on the front side 14 of the base 12, the bag 28 can be rolled back on an outer periphery of the base. base 12 so that both sections 34, 36 are effectively removed from the area of the opening 26 in a rearward direction of the base 12. This is done with the bag 28 preferably partially inflated to provide stability to the bag when it is rolls the bag back from the base 12. The pump 42, as illustrated, may be connected to the base 12 to provide a handling device for complete assembly of the base 12, the bag 28 and the pump 42 during the procedures which are described later. As illustrated in Figure 8, with the bag 28 wound back, a remote area 62 of a remaining limb or member 64 to be fixed with an adapter sleeve for prosthesis is fixed with a suction cap or sleeve 66 of the silicone elastomer. , for example, a silicone rubber sleeve of the type sold under the name of ICEROSS® manufactured by Ossur HF of Reykjavik, Iceland. Such suction sleeves are well known and are sold by various manufacturers such as a cushion coating so that prosthetic caps are connected to prosthetic devices such as artificial legs and feet. The term "suction cap" connotes that the cap fits over the remote area of a remaining limb in an airtight manner so that it does not become separated from the skin of the remaining limb or limb. The suction cap 66 closely conforms to the remote area 62 of the remaining end 64 and includes an end adjusting device 68 to which a tension element 70 is fixed which will be described in more detail with reference to the description of the Figure 12 later. The tension element 70 rigidly interconnects the final adjustment device 68 of the suction cap 66 with the base 12 via the opening 26 and the connector of the releasable tension element 24. A material for a moldable and settable sleeve 72 includes, in accordance with a preferred embodiment of the invention, but which may be omitted, if desired, a coupler of the prosthesis device 74 located in its remote end area. The prosthesis bushing material 72 is preferably an uncured, preformed, reinforcing and settable material mixture, preferably preferably curable material curable by water, which can be provided rolled and which can be unrolled or provided over the remote area. of the remaining member 62 in substantially the same shape as the suction sleeve 66. The adapter sleeve material for prosthesis 72 with or without a prosthesis coupler 74 can be wound onto the suction socket 66 with the tension element 70 which extends through the remote end area of the prosthesis cap material 72 and, optionally, prosthesis device coupler 74. Thus, the rolled back bag 28 provides access to the side or front of the base 12 at least in the area thereof that receives the tension element 70 so that the remote area 64 of the remaining member, the suction cap 66, the material of the cap for "uncured prosthesis 72 and, optionally, the prosthesis coupler 74, can be located so that it occupies the molding area 38 when the sheet 28 is bent or rolled backwards on the base 12 to assume its forward molding position, as illustrated in Figures 9 and 10. As shown in Figure 9, the bag 28 is in the process of being rolled forward relatively to the base 12. with the bag 28 partially inflated at a selected pressure which makes possible the convenient rolling of the bag 28 on the base 12 while wrapping the remote area 62 of the remaining limb or member 64 with the suction cap 66 and the prosthesis cap material 72 located in a molding position while being secured to the base 12 through the tension element 70. The bag 28 is rolled forward as shown in Figure 10 until the material is completely wrapped molding 72 within a molding area 38 defined by the inner tubular section 34 of the bag 28. Of course, when the prosthesis cap material 72 and the remote area of the remaining limb or limb 62 are wrapped around the molding area 38 it is distorted in a volume larger than its relaxed volume without the remaining limb, the suction cap and the prosthesis material located in the molding area. During pressurization of the bag 28 at a selected pressure, for example 10 mm of mercury, the remote area 62 of the remaining limb causes it to be compressed circumferentially together with the prosthesis cap material 72 and the suction cap 66, with the result of a reaction force being created between the connector of the tension element on the base 12 and the tension bolt 70 so that the base 12 exerts an attractive force on the tension element 70 in a relative remote direction of the remote area of the remaining end 62, as indicated by the arrow 76. However, the base element 12 is connected to the tension element 70 and when it is driven in a direction away by the pneumatic pressure in the bag, it applies an attractive force to the element 70 which is transmitted to the end fitting or securing device 68 of the suction sleeve 66 in the direction of arrow 76 to cause an axial force to be applied each to the suction cap 66 whereby the remote area 62 of the remaining end 64 is lengthened and tensed to cause the remote area to be reduced in diameter and elongated a little under pressure from the inflation bag 28. Prior to winding the bag 28 on the molding or prosthetic cap material 72, the cap material is conditioned to initiate curing of the cap material, preferably by shaking the cap material in water or other fluid which is convenient and safe to use in an environment of molding of the cap. Thus, while healing, the remote area 62 is comprised of the inflated bag 28 and a charged tension reaction is imposed on the remote area 62 of the remaining limb by the reaction force created by the inflation of the bag against the element. of base 12 which creates a pulling force on the element 70 thereby tension and elongation of the remote area 62 of the remaining end while the material 72 is undergoing curing under pressure in the molding area from the inflated bag 28. As illustrated in Figure 11, the pump 42 can be removed from the base 12 during curing of the material 72 over an appropriate period of time, required to cure the material of the prosthesis socket. Figure 12 illustrates a preferred embodiment of base 12 and associated structure, including bag 28 in more detail. The mounting of the suction cap 66, the cap material 72, the coupling of the prosthetic device 74, and the end fitting or fixation 68 and the tension pin 70 are described in the US Patent Application S.N. 08 / 559,311 pending, filed November 15, 1995, and co-approved by the Signatory of the present invention, which is incorporated herein by reference. Essentially, the suction bushing 66 is formed of a highly flexible silicone elastomer which may or may not be reinforced with fabric or filaments to control the distention of the suction bushing at least in the remote direction while allowing distension of the bushing. suction in the radial direction. The final fastening device 68 is molded into the body of the suction socket 66 and includes a threaded fastening device for receiving a threaded end of the tension element 70 formed as a pin having elongated ridges or projections 78 therein that interact with the latter. releasable tension element connector 24 to allow positive engagement in various positions between bolt 70 and base 12 when bolt 70 is progressively advanced into opening 26 (see Figure 1) in base 12 when the remote area 62 of the remaining limb, the suction cap 66, the prosthesis material 72 and the coupler 74 are advanced in engagement with the side or front portion 14 of the base element 12. A stabilizer ring 80 can be threaded onto a threaded portion of the element of tension 70 for centering and stabilizing the prosthesis coupler 74 relative to the pin 70 and for retaining a metal ring 82 securing the prosthetic sleeve material 72 to the prosthesis coupler 74 during molding and setting or hardening of the sleeve material 72. The coupler of the prosthesis device 74 preferably includes external peripheral ridges or notches that couple the prosthesis sleeve material 72 to form a firm connection between the coupler 74 and the prosthesis cap material 72 when the cap material is completely cured. The stabilizer ring 80 is removed from the assembly after the tension element 70 has been released from the base 12 followed by the curing of the prosthesis cap material 72. The prosthesis cap material 72, for example, can comprise any suitable combination of hardenable (curable) molding compounds and reinforcing materials that allow the formation of a definite cap having the necessary or desirable physical characteristics for a prosthesis cap, for example, a definite cap to be placed with a prosthetic device attached to the coupler of the prosthetic device 74. A preferred embodiment of a sleeve preform comprises a braided, tubular, flexible or elastic carbon fiber sleeve similar to the weft available from Atkins &; Pierce, - 2 Braid Way, Covington, Kentucky as products to us. WGM4, WGM5.00 and WGM6.00 (4", 5" and 6", respectively, biaxial carbon fiber sleeves), preimpregnated with a water-curable polyisocyanate-type prepolymer resin 47, available under ID No. 41-3701 -0524-3 from 3M Company of Minneapolis, MN This resin can be activated and rendered moldable by the addition of water to the resin and cured to a hardened condition very quickly in a typical form of such resins. 72 does not constitute a part of this invention and is described herein for a full understanding of the invention Similarly, the material constituting the suction bush 6 does not constitute a part of this invention per se in addition to its structural arrangement and function as already described, clearly, any appropriate suction socket could be used as a suction socket 66, provided that it closely matches the remote area 62 of a remaining end with a tension element. Ion 70 so that, during the tension applied to the tension element 70, the axial force will be transmitted to the end fitting device or end 68 in the suction socket 66 and then transferred to the remote area 62 of the remaining end whereby the area remote from the remaining limb is lengthened and tensed while the circumference of the remote area is reduced in response to the tension force. In addition, the prosthetic material 72 can be constituted of any mouldable material and fit usable as a definite cap or otherwise as a cap to be associated with an area remote from a residual limb in narrow locking relationship. It will be understood that the bushing 72 is normally placed on a suction bushing 66 during use, so the presence of the bushing 66 during the molding of the prosthesis bushing material 72 results in an appropriately fixed and circumscribed prosthesis adapter bushing when the material 72 It is cured. The pressure pads can be incorporated into the prosthesis socket when necessary according to known techniques. The use of the stabilizer ring 80 is optional and the dimensions of the ring 80 can be varied to continue with several assemblies of suction cup 66, prosthesis material 72, coupler for prosthesis 74 and tension element 70. As seen in the Figure 12, the connector of the tension element 24 is accessible from the front part 14 of the base element 12 when the bag 28 is wound backwards relative to the base element 12 so as to release the tension element 70 followed by molding and setting or adjustment of the prosthesis material 72 and at least partial deflation of the bag 28, as illustrated, for example, in Figure 7. Accordingly, the operation of the molding device of the prosthesis adapter sleeve will be easily understood from the description preceding. More specifically, performing the forming or "molding" of a prosthesis socket from a castable or castable prosthesis material 72, the following procedure may continue to use the apparatus described above. A suction cap 66 is first used on a remote area 62 of a remaining limb or member 64 with the tension member 70 extending in a direction away from the remote or distal area of the remaining member. A moldable and settable or adjustable bushing material 72 is then placed on the suction bushing 66, for example by extending or using a preformed prosthesis bushing material on the suction bushing 66 so as to conform closely to the outer contour of the bushing. of suction 66 with the tension element 70 extending through and beyond the prosthesis cap material 72.

If a prosthesis coupler 74 is provided, the tension member freely extends through the coupler 74. The material of the prosthesis adapter sleeve 72 is preferably pre-formed with a coupler 74 and a metal retainer ring 82 as illustrated in FIG. Figure 12. The stabilizing ring 80 is then screwed into the tension element 70 to stabilize the position of the tension element 70 relative to the prosthetic or prosthetic coupler 74 and to the center of the pivot 70 in the base element 12. The front side 14 of the base member 12 may include a projection containing the connector of the tension member 24 and the opening 26, all as illustrated in Figures 1 and 12. The bladder or bag 28 is wound back relative to the base member 12 a a position as shown in Figure 7 to show the opening 26 and the connector of the tension element 24. Preferably, the bladder or bag is partially inflated to facilitate its nipulation to the position shown in Figure 7. The tension element is then inserted into the opening 26 where the projection fits over that to the connector of the tension element 24 with the elements arranged as shown in Figure 8. The bladder or bag 28 is then rolled forward relative to base 12 and distal area 62 of the remaining extremity as shown at 9 and 10. When fully extended to the forward position as shown in Figure 10, the bladder or bag 28 is then inflated by a hand pump 42 which has been secured to the base 12 as shown in Figure 10 to allow the supply of pressurized air to the interior of the bladder 28 as illustrated, for example, in Figure 6. When inflated, the bladder assumes the position as shown in Figures 11 and 12 where the distal area 62 of the remaining limb 64 is confined in the molding area 38 along with the suction cap 66 and the mat. adapter sleeve for prosthesis 72. After selective inflation of the bladder 28 (for example up to approximately 10 mm Hg), the distal area of the remaining limb, the suction adapter sleeve and the adapter sleeve material for the prosthesis is compressed radially and circumferentially within the molding area 38 by the inner section 34 of the bladder or bag 28. However, due to the volume of the distal area of the remaining limb 62, the suction adapter sleeve 66, and the adapter sleeve material for prosthesis 72 is so large that the normal void or relaxed volume of the molding area 38, and also due to the tapered configuration typical of a distal area of the remaining limb, a pure resultant force is produced by the inflation of the bladder 28 tending to pushing the base member 12 back away from the distal area of the remaining limb due to the force generated by the pneumatic pressure within the vej iga 28. This resultant force is transmitted to the tension member 70 in a general proportion to the pressure inside the bladder 28 and the force in turn is transmitted as a pulling force to the end coupler or adjuster 68 and to the adapter sleeve by suction 66. The tensile force exerted on the distal end of the adapter sleeve 66 is transmitted to the distal area 62 of the remaining extremity to thereby cause dilation or expansion, elongation and reduction in diameter of the distal area 62 of the remaining extremity in a distal direction, while, at the same time, the pressure within the bladder or bag 28 radially and circumferentially compresses the distal area of the remaining limb with the prosthesis adapter sleeve material 72 confined between the inner section 34 of the bladder 28 and the "adapter socket". suction 66. The pure result of the compression and the tension load applied to the distal area 62 of the remaining end, the Adapter cap for prosthesis and suction adapter cap .66 results in a closed adapter and adjuster correctly configured to the adapter sleeve for prosthesis formed from the new adapter sleeve material for serial and hardened prostheses 72. Release of tension element 70 by manipulating the connector of the tension element 24 allows the separation of the base element 12 and the bladder 28 from the distal area of the residual limb, the suction adapter sleeve and the adapter sleeve for prosthesis formed from the hardening adapter material. The tension pivot then released from the ring 80 and the end adjuster 68 and the prosthesis adapter sleeve are separated from the suction adapter sleeve 66 in a known manner. The adapter sleeve material for hardened prosthesis 72 can then be finally adjusted to the extent necessary to provide a comfortable prosthesis adapter sleeve that is in a substantially finished form when it is released from the suction adapter 66 and the distal area of the remaining extremity 62. A prosthesis device, if desired, can then be connected to the prosthesis coupler 74 in a known and conventional manner. The deflation of the bladder or bag 28 can of course be carried out by the use of the pressure relief valve 58, associated with the pump 42 or by other suitable means which can be adapted quickly by one skilled in the art. It will be noted that a completely self-contained prosthesis adapter molding device is provided by the apparatus described herein, which is typically used simply by simple assembly to the distal area of a remaining limb without any other traction force generating implement. or support. The tensile force exerted on the tension element 70 in the manner described above is created by the same molding device as a result of the forces generated during the molding process. For some applications, it may be desirable to omit the connector of the tension element 24 in the base member 12 so that the bladder or pouch 28 can be used simply as a compression device during the molding of a prosthesis cap material, settable , mouldable 72 without reacting the tension load in a tension element 70. For example, in the case that a simple plasticizer of pairs of caps for prostheses or the like is formed using the caps for prostheses or devices and molding process described, an arrangement may be used as illustrated in Figure 14, wherein the base member 12 does not include a connector of the tension member and preferably a center or guide pivot 86 extending through the opening of the base member 26 in a centered and stabilized manner may be used with or without the application of the separate or pre-charged tension force applied to the pivot 86 by some ex-source The air passage and air sealing devices, of course, may be provided to maintain the pressure inside the bladder or bag 28 by following its direction from the external position of the backward side of the base element 12. inflated, as previously described. When this socket device arrangement is used, a separator or opening or gap 88 may be provided between the distal end of the suction adapter sleeve 66 and the adjacent surface or side of the prosthesis coupler 74 or the front side of the base element 12 in the fact that a coupler 74 is not used. The space 88 may allow the distal area 62 of the residual limb to sometimes expand in a distal direction during compression of the prosthetic material 72 by the inflated bladder or bag. By using the embodiment illustrated in Figure 14, the air pressure in the bladder or bag 28 can be carefully regulated as well as for controlling the distal displacement of the base member 12 by the air pressure in the bladder. However, it will be noted that the pivot 86 freely extends through the base element 12 so that the base member 12 is free to move a few times in a distal direction relative to the suction adapter sleeve 66 when the bladder or bag it inflates. The specific embodiments of the invention described herein are intended to be illustrative only and various modifications and implementations may be observed thereto by one skilled in the art without departing from the spirit and scope of the invention which is defined in the following claims. It is noted that in relation to this date, the best method known by the applicant to carry out the aforementioned invention, is that which is clear from the present description of the invention. Having described the invention as above, the content of the following is claimed as property.

Claims (38)

1. An adapter sleeve device for prostheses, characterized in that it comprises: a base having a front side; an elongated annular molded bladder carried by the base, the bladder peripherally enclosing a cap area generally located centrally when inflated and extending from the front side of the base, the bladder further comprises a relatively non-narrow, impermeable sheet material air, flexible, enclosing in cooperation with the base, an air chamber peripherally rounding the area of the cap; said bushing area includes an opening of the receiving end of the residual limb and extending from said end to the base; and an air passage that allows the controllable supply of the pressurized air to the air chamber.

2. An adapter cap device for prostheses according to claim 1, characterized in that said bladder comprises: a continuous tubular element having opposite ends and extending between said opposite ends with a portion of the same fold inside on the remaining portion of the bladder. same; said opposite ends secure the seal to said base; said air chamber is located between the collapsible layers of the tubular element.

3. An adapter cap device for prosthesis, according to claim 1, characterized in that said bladder comprises: an internal tube section having opposite ends and ensuring the sealing of one end to the base; an outer tube section having opposite ends and extending over the section of the inner tube in spaced relationship therewith, said outer tube section also securing the seal at one end to the base; said internal and external tube sections coupled sealed to opposite ends located on said opposite base; said air chamber defined by the separation between the internal and external tube sections; the end of the outer tube is secured to the base relatively substantially concentrically to one end of the inner tube.

4. An adapter cap device for prostheses according to claim 2, characterized in that said opposite ends are secured substantially concentrically to the front side of the base.

5. An adapter sleeve device for prostheses according to claim 2, characterized in that said continuous tubular element is continuously wound or rolled on the base element in a backward direction opposite to the front side of the base as well as for wrapping the base element. base to at least one position.

6. An adapter cap device for prosthesis according to claim 1, characterized in that it includes a connector of the releasable tension element made by the base.

7. An adapter sleeve device for prostheses according to claim 4, characterized in that it includes a connector of the releasable tension member made by the base; said connector of the tension element is located inside the end of the inner tube.

8. An adapter sleeve device for prosthesis according to claim 7, characterized in that it includes a release mechanism for the tension connector member located in the base within the end of the inner tube.

9. An adapter cap device for prosthesis according to claim 1, characterized in that it includes a connector of the tension element, located on the front side of the base to an accessible position from said molding area.

10. An adapter cap device for prostheses according to claim 1, characterized in that said air passage comprises an air passage in the base in communication with the air chamber; and a valve in the passage of the air placed to control the flow of air through the passage.

11. An adapter cap device for prostheses according to claim 10, characterized in that said air valve comprises a normally closed check valve which prevents the air from leaving the air chamber when closed, but which is opened to allow to air pass through the passage of air in any direction.

12. An adapter sleeve device for prostheses according to claim 10, characterized in that said air passage includes a quick release air release coupling arrangement for receiving a quick release / meshing adjusting pump.

13. An adapter sleeve device for prosthesis according to claim 12, characterized in that said valve comprises a normally closed check valve and a tilting device for tilting the check valve towards a closed position.

14. An adapter sleeve device for prosthesis according to claim 13, characterized in that it includes a quick release / meshing adjusting pump to cooperate with and to receive by the air passage coupling: said adjuster pump includes an air valve opener positioned to open the check valve when the adjuster pump and the air passage coupling are geared together.

15. An adapter sleeve device for prosthesis according to claim 14, characterized in that said pump includes a movable manual air displacer to cause a flow of pressurized air through the adjuster pump when it is moved; and a pressure measurement to indicate the static air pressure in the air supply duct and said bladder when the check valve is opened and the air passage coupling is engaged with the adjusting pump.

16. An adapter cap device for prostheses characterized in that it comprises: a base having a front side; an elongated, annular molded bladder made by the base, the bladder peripherally enclosing a cap area generally located centrally when inflated and extending from the front side of the base, the bladder further comprises a relatively narrow, impermeable sheet material in the air, relatively non-narrowing, flexible, enclosing in cooperation with the base, an air chamber peripherally rounding the area of the cap; said bushing area includes an opening of the receiving end of the residual limb and extending to the base; an air passage that allows the controlled supply of pressurized air to the air chamber. • a suction adapter of the remaining limb in said socket area, said suction adapter sleeve being arranged to receive a distal area of the remaining limb and includes a closed end located adjacent said base; • To an adapter material for castable fragile prosthesis placed on the adapter sleeve by suction between the suction adapter sleeve and the bladder; said cap area when emptied and when the bladder is inflated to fully extend to the bladder is smaller in volume than the volume of said adapter cap fitting by suction to a distal area of the remaining limb and said molding material.

17. An adapter sleeve device for prosthesis according to claim 16, characterized in that said bladder comprises a continuous tubular element having opposite ends and extending between said opposite ends with a portion thereof folded outwardly on the remaining portion thereof; said opposite sealing ends secure said base; said air chamber is located between the folded layers of the tubular element.

18. An adapter sleeve device for prosthesis according to claim 17, characterized in that said opposite ends are secured substantially concentrically towards the front side of the base.

19. An adapter sleeve device for prostheses according to claim 18, characterized in that it includes a tension release element connector in the base and a release mechanism for the tension element connector located in the base within the end of the tube. inside.

20. An adapter sleeve device for prostheses according to claim 16, characterized in that it includes a connector of the releasable tension element made by the base; a tension element secured to the closed end of the adapter bushing by suction; said tension element extends towards and engages the connector of the tension element so that the tension adapter end is releasably coupled to said base by the tension element; the connector of the tension element is placed on the front side of the base at an accessible position of said bushing area.

21. An adapter cap device for prostheses according to claim 16, characterized in that said air passage comprises an air passage in the base, in communication with the air chamber; and a valve in the air passage positioned to control the flow of air through the passage, said air valve comprises a normally closed check valve, but which opens to allow passage of air through air passage in any direction .

22. An adapter sleeve device for prostheses according to claim 16, characterized in that said passage of air comprises an air passage in the base in communication with the air chamber; and a valve in the air passage positioned to control the flow of air through the passage, said air passage includes a quick-release air release coupling arrangement for receiving a quick release / engagement adjusting pump; said valve comprises a normally closed check valve and a tilting device for tilting the check valve to a closed position; an air pump including a quick release / gear adjusting pump configured to cooperate with and to be received by the air passage coupling; said adjusting pump includes an air valve opener positioned to open the check valve when the fixing pump and air passage coupling are placed together; said pump includes a movable manual air displacer to cause a flow of pressurized air through the adjusting pump when it is moved and a pressure measurement to indicate the static air pressure in the air supply duct and the bladder when it is opened the check valve and the coupling of the air passage are placed with the air adjusting pump.

23. An adapter sleeve device for prosthesis according to claim 20, characterized in that it includes a tension indicator to indicate the tension forces between the tension element and the tension element connector when the bladder is inflated to exert a compression force in the material of adapter sleeve for prosthesis and a suction adapter sleeve containing a distal area of the remaining end located in said sleeve area.

24. An adapter sleeve device for prostheses according to claim 16, characterized in that it includes a connector of the releasable tension element carried by the base; a tension element secured to the closed end of the adapter bushing by suction; said tension element extends towards and engages the connector of the tension element so that the end of the suction adapter sleeve is releasably coupled to said base by the tension element; and including a prosthesis coupler attached to the coupling sleeve material, the prosthesis coupler is located adjacent the closed end of the adapter sleeve by suction between the end of the suction adapter sleeve and the base; the coupler includes an opening that extends through it; the tension element extends through the opening in the coupler with the coupler located between the closed end of the suction adapter sleeve and the tension element connector.

25. A cap method for a device for prosthesis in a distal area of a remaining limb, characterized in that it comprises: placing a suction adapter sleeve including a tension element to a closed distal end thereof on a distal area of a remaining limb with the tension element extending externally in a distal direction; placing a non-hardening, castable and castable prosthetic device material and in closed conformity with the adapter sleeve by suction and so that the tension element extends in a distal direction through the prosthesis device material; mounting an inflatable annular bladder comprising a relatively inextensible flexible material in a base member to produce a central open cap area extending from a front side of the base member toward a central opening for receiving the remaining remaining end of the base element when the bladder is inflated and positioned to extend from the base element in a forward direction, the bladder is movable by a rolling action of the bladder relative to the base element in front and rear directions; bladder bearing again from the front side of the base member to provide access to the area of the cap by the distal area of the remaining limb, the material of the prosthesis device and the adapter sleeve by suction and access to the base member by the end element. tension; coupling the tension element to the front side of the base element to restrict relative movement in the distal direction between the tension element and the base element while being placed in the < A distal of the remaining limb, the adapter socket by suction and the material of the prosthesis device in the socket area; bearing of the front bladder relative to the base element to a position with which it extends forwardly of the base element and wraps the distal area of the remaining extremity, the suction adapter and the prosthesis device material in the area of the socket while, the tension element is connected to the base element; inflate the bladder at a selected pressure to cause the bladder material to extend internally to the area of the cap to compress the distal area of the remaining limb, the adapter by suction and the prosthesis device material and cause a reaction force between the tension element and the base element causing the base element to exert a tensile force on the tension element when the bladder is selectively inflated to such a forward position; maintaining the distal area of the remaining limb, the adapter sleeve by suction and the material of the prosthesis device under compression and the tensile element under tension of the tensile force during the hardening of the prosthesis device material; releasing the air pressure from the bladder, releasing the tension element and separating the distal area of the remaining limb, the suction adapter sleeve and the prosthetic device material hardened from the bladder and the base element.

26. The method according to claim 25, characterized in that it includes carrying out the step of inflating the bladder by releasing a selective inflatable air pressure through an air passage in the base element to an air chamber of the bladder.

27. The method according to claim 25, characterized in that it includes the use as the bladder of a tubular element of a single piece partially internally folded on itself to form the internal and external tubular sections having a pair of free sealing ends connected to the element base with the spacing between the tubular sections defining an inflatable air chamber and the spacing within the internal tubular section defining the area of the cap, and leading the bladder rolling step back to the front side of the base element by the rolling of both tubular sections together relative to the base element in a rearward or rearward direction of the base member to provide access to the tension element to the front side of the base member.

28. The method according to claim 25, characterized in that it includes providing a coupling device for prostheses in the distal area of the prosthesis device material; which extends the tension element freely through the coupler of the prosthesis device when the tension element is coupled to the base element with the prosthesis coupling device placed between the end of the distal area and the suction adapter sleeve and the base element , and permanently together to the coupler of the device for prosthesis and the material for prosthesis during the hardening of the material of the device for prosthesis.

29. A cap method of a device for prostheses in a distal area of the remaining limb, characterized in that it includes positioning a non-hardening, settable and movable prosthesis device material on and in closed compliance with a distal area of a remaining limb; mounting an inflatable annular bladder comprising a relatively inextensible flexible material in a base member to produce a central open cap area extending from a front side of the base member toward a central opening for receiving the remaining remaining end of the base element when the bladder is inflated and placed to extend from the base element in a forward direction, the bladder is movable by a rolling action of the bladder relative to the base element in front and rear directions; the bladder bearing again from the front side of the base element provides access to the area of the cap by the distal area of the remaining element, and the material of the prosthesis device; placing the distal area of the remaining limb with the material of the prosthetic device in the area of the socket adjacent to the base element; rolling the front bladder relative to the base element to a position with which it extends forwardly of the base member and envelops the distal area of the remaining extremity, and the material of the prosthetic device in the socket area; inflating the bladder at a selected pressure to cause the bladder material to extend internally to the area of the socket to compress the distal area of the remaining limb, and the material of the prosthetic device; maintaining the distal area of the remaining limb, and the material of the prosthetic device under compression during hardening of the prosthetic device or prosthesis material; release air pressure from the bladder, and separate the distal area from the remaining limb, and the hardened prosthetic device material from the bladder and base element.

30. The method according to claim 29 characterized in that it includes a bearing in the posterior bladder relative to the base element when performing the step of separating the distal area of the remaining limb and the material of the prosthetic device hardened from the bladder and the element of base.

31. The method according to claim 29, characterized in that it includes carrying out the step of inflating the bladder by releasing a selective inflating air pressure through an air passage in the base element to an air chamber of the bladder.

32. The method according to claim 29, characterized in that it includes the use as the bladder of a tubular element partially internally folded on itself to form the internal and external sections having a pair of free ends connected sealed to the base element with the separation between the sections that define an inflatable air chamber and the separation within the internal tubular section that defines the area of the cap, and that performs the step of rolling the bladder again from the front side of the base element by the bearing of both tubular sections together with the base member in a rearward or rearward direction of the base member to provide access of the distal area of the remaining extremity and the material of the prosthesis device to the front side of the base member.

33. The method according to claim 32, characterized in that it includes placing a section of adapter sleeve over the distal area of the distal region of the remaining end before placing a non-curable prosthesis device material, • A castable and moldable over the distal area; and performing the hardening of the prosthesis device material under compression from the inflated bladder while the material of the prosthesis device is maintained in closed compliance with the distal area of the remaining end and the adapter sleeve by suction.

34. An adapter sleeve device for prostheses by the socket of an adapter corresponding to a distal end of the remaining end; characterized in that it comprises: an adapter sleeve for suction prosthesis that includes an end adjuster to a distal end of the adapter sleeve; a voltage element connected to the end adjuster; a connecting device of the tension element including a structure capable of releasably engaging and retaining against the downwardly tensioning element when the tension element is coupled to said connector device; an elongated annular molding bladder, which includes internal and external walls connected to the tension element in a manner that reacts a tension force in the distal direction between the tension element and the bladder when the bladder is inflated over a cap area in The central general area containing a remaining end end on which said prosthetic adapter bushing or for suction-type prosthesis has been placed, the generally central bushing area is defined by the inner wall of the bladder, the internal and external walls of the bladder are further formed from a relatively non-narrow, air-impermeable, flexible sheet material which defines an air chamber between the inner and outer walls which peripherally round the area of the cap; said bushing area includes an open end for receiving a suction adapter bushing and the tension element; and an air passage arrangement that allows controlled supply of pressurized air to the air chamber.

35. The adapter sleeve device for prosthesis according to claim 34, characterized in that said bladder comprises a tubular element continuously rolling on the connector of the tension element towards and in the form of a suction adapter sleeve located in the area of the sleeve.

36. An adapter cap device for prostheses according to claim 34, characterized in that it includes a connector releasing device of the tension element made by the connector device of the tension element.

37. An adapter sleeve device for prosthesis according to claim 34, characterized in that it includes a molding material of the device for prosthesis, settable and mouldable configured to be fixed between a suction adapter sleeve inserted in the area of the sleeve and the bladder.

38. A cap method for a prosthesis device corresponding to a distal area of a remaining end, characterized in that it comprises: placing a suction adapter sleeve including a tension element to a closed distal end thereof on an element corresponding to an area distal of the remaining end with the tension element extending in a distal direction; connecting the voltage element to a device that connects the tension element that engages releasably and that retains the tension element against the retraction; placing a non-hardened, settable and moldable prosthesis device material on and in close conformity with the suction adapter sleeve positioned on the tension element extending distally beyond the material of the prosthetic device; place or mount an annular bladder, inflatable that includes internal and external walls that define an air chamber and are formed of a relatively inextensible flexible material and that generally defines a central bushing area within the inner wall that has a minimum volume when the air chamber is inflated which is smaller than the volume of the adapter sleeve by suction placed on the material of the prosthetic device sleeve and of the adapter sleeve placed and furthermore with the bladder engaged the connecting device of the tension element, so that the reaction allows the tension force in the distal direction in the tension element and the bladder; inflate the air chamber to reduce the volume of the area of the cap to cause compression of the material of the prosthetic device on the adapter sleeve by placed suction and to cause the tensioning of the tension element by the resultant reaction forces created between the bladder and the suction cap placed via the tension element in a distal direction when the bladder is inflated; hardening the material of the prosthetic adapter socket while the material of the prosthetic adapter sleeve is compressing the adapter cap material placed under tension by the reaction forces; deflate the air chamber and remove it from the material of the hardened prosthetic adapter socket; Separate the material from the prosthetic adapter socket from the adapter sleeve by suction.