Patent Application
20070055383
The present invention relates to the field of prosthetics, and, more particularly, to prosthetic device socket liners, related systems and related methods.
Excessive heat, perspiration and daily residual limb volume fluctuations are problems encountered by the amputee population wearing a prosthetic liner and limb. The prosthetic liner, which is donned upon the residual limb of the amputee, for both suspension and alleviation of shear and pressure on the residual limb, can be described as a non-porous elastomeric material with high thermal insulation properties. A prosthetic liner seals off air flow to the residual limb, which results in heat and perspiration build up. Because of these factors and especially in hot climates the skin of the residual limb becomes susceptible to infections, allergies and other skin diseases. Perspiration decreases the friction between the residual limb and the liner. This can cause a pistoning action between the liner and limb that macerates the skin, as well as create the potential for catastrophic failure of the suspension of the limb.
Daily volume loss is also a widespread problem of amputees. A study conducted by W. Board, G. Street and C. Caspers, entitled A comparison of Trans-Tibal Amputee Suction and Vacuum Socket Conditions (Prosthetic and Orthotics International, 2001, 25) found that on average the residual limb volume of the test subjects decreased by 6.5 & during only a thirty minute walk (page 205). Volume loss leads to diminished proprioception, poor fit of the socket and discomfort. Bony prominences can also experience higher shear and pressure because of the change in the residual limb volume.
There are prior art examples of an elevated vacuum being applied directly to the skin of the amputee. For example, U.S. Pat. No. 5,888,230 and U.S. Pat. No. 6,231,616 both to Helmy and both described as MODULAR LINER FOR LIMB RESIDUAL LIMB PROSTHESIS. These patents describe the use of vacuum to remove interstitial spacing or gapping in a prosthetic liner; an even application of vacuum is not distributed over the residual limb. The liner inherently seals locally to the vacuum source in contact with the skin, given the pliable nature of both.
U.S. Pat. No. 6,974,484 to Caspers and described as OSMOSTIC MEMBRANE and VACUUM SYSTEM for ARTIFICIAL LIMB specifically details the use of an osmotic membrane for perspiration removal from an artificial limb. An osmotic membrane is a selectively permeable membrane “that allows water vapor to pass from the limb but prevents liquid from passing to the limb.” Although U.S. Pat. No. 6,974,484 uses an osmotic membrane, it does not allow the inflow of air while maintaining a vacuum between limb and liner.
In the prior art there is an example of a prosthetic liner fitted with a check valve. U.S. Pat. No. 6,544,292 to Laghi describes a device as a PROSTHETIC LINER WITH INTEGRAL AIR EXPULSION VALVE. This patent depicts a prosthetic liner with an air expulsion valve built into the walls of the liner, to facilitate donning of the liner and creating an airtight seal upon the limb. There is no mention of perspiration removal or its application with elevated vacuum. Also, U.S. Pat. No. 5,728,169 to Norvell details a moisture retention prevention interface between the limb and prosthetic liner. There is no mention of the vacuum source or of any mass air flow mechanism in this patent.
U.S. Patent Application Publication No. 2004/0167447 to Johnson describes a device as an Orthopedic Appliance with Moisture Management System. This application shows the use of a fabric liner “serving to wick away moisture directly through. . . vent holes.” There is no mention of elevated vacuum creating a mass air flow mechanism in this patent. U.S. Patent Application Publication No. 2005/0197611 Taranow described as a VACUUM-SEALED ORTHOTIC, PROSTHETIC, and OTHER BODY WORN DEVICES details designs that provide “active suctioning” of “evacuatable sleeve” used for suspension of a “artificial foot or leg” or “artificial hand or arm.” The design is basically for a sleeve suspension of an artificial limb that sub-atmospheric pressure is applied to. There is no mention of perspiration removal, or any means of maintaining the vacuum inside the suspension sleeve once evacuated.
U.S. Pat. No. 6,726,726 to Caspers described as a VACUUM APPARATUS AND METHOD FOR MANAGING RESIDUAL LIMB VOLUME IN AN ARTIFICIAL LIMB, details the trouble with “edema and blistering at the point on the residual limb where the suspension sleeve contacts the residual limb.” Given the configuration detailed in this patent, unregulated vacuum was being exposed to skin of the amputee above the liner and beneath the sealing sleeve. Because of the gap that formed from the thickness of the liner, and a sleeve rolled over it and up on the thigh, edema and blistering occurred when unregulated vacuum was applied to the created void. This passage is cited because this was a potential mechanism that perspiration could be pulled from between the limb and liner, migrating up from the proximal aspect of the liner. The patent details several designs to prevent this occurrence but in practice by the manufacturer, the liner was made longer, extended up on the thigh preventing the sealing sleeve from extending beyond the proximal aspect of the liner, ultimately stopping unregulated vacuum from being exposed to the skin of the amputee.
Limb volume management is described in the study entitled, A Comparison of Trans-Tibial Amputee Suction and Vacuum Socket Conditions, by W. Board, G. Street, and C. Caspers published in Prosthetics and Orthotics International, 2001; vol. 25, 202-209.
Suction suspension of an artificial limb is a standard accepted prosthetic design protocol. An example of the prior art for a prosthetic suction valve is U.S. Pat. No. 2,834,025 (Leavy , Jerry D.) for a device described as SUCTION DEVICE FOR PROSTHETIC LIMB [1958]. This patent describes a one-way valve which can be disassembled so that a donning sheath can be pulled through its opening and reassembled maintaining the suction or vacuum seal. Suction suspension of this sort can be classified as non-elevated vacuum suspension and is employed throughout prosthetic practice, in limbs with or without prosthetic liners.
It has long been established in clinical practice that suction suspension is optimal for certain levels of amputation. The observed benefits are control of edema, improved circulation, improved control of the prosthesis, and increased proprioception. It was until very recently that suction suspension implied non-elevated vacuum suspension.
Elevated vacuum via mechanical or electronic vacuum pumps is a relatively new, but accepted, practice. As a measure of the new general acceptance of the use of these devices, the Federal Government, through its Medicare administration, effective Jan. 1, 2003, has assigned specific L-codes to prosthetic vacuum pumps, L5781 and L5782 respectively. L5781 reads: Addition to lower limb prosthesis, vacuum pump, residual limb volume management and moisture evacuation system (L5782 is for a higher weight capacity vacuum pump).
It should be noted that none of the commercially available vacuum pumps have ever reliably achieved moisture evacuation in a prosthetic socket. U.S. Pat. No. 6,726,726 to Caspers, Carl A. for a device detailed as VACUUM APPARATUS AND METHOD FOR MANAGING RESIDUAL LIMB VOLUME IN AN ARTIFICIAL LIMB is a continuation of a series of patents for a popular prosthetic vacuum pump. In the description of the preferred embodiment, it is revealed that “the vacuum which holds the residual limb (and liner) in firm contact with the socket tends to cause edema and blistering at the point on the residual limb where the suspension sleeve contacts the residual limb.” This is the only area for moisture to evacuate from the liner and it was initially believed to be a viable way for perspiration control, as evidenced by the description of the Medicare L-Code. When reduced to practice, unregulated vacuum applied to human skin caused breakdowns as described above. If regulated vacuum was applied to this area, effective perspiration removal would not occur because of the inefficiency of the design.
Prosthetic liners are prevalent throughout prosthetics. An example of the prior art for a method of constructing a pliable prosthetic liner is found in U.S. Pat. No. 3,377,416 to Krandel described as METHOD OF MAKING LINER FOR ARTIFICIAL LIMB. This patent describes the fabrication method of creating a R.T.V. rubber prosthetic liner, whose “support is obtained from the entire stump surface.” This foreshadows the coming acceptance and use of total surface bearing prosthetic liners, where the load and shear forces of a prosthetic socket are distributed evenly over the flexible liner, which is donned upon the amputee's residual limb.
A problem with a total surface bearing (TSB) socket and liner can be found in the abstract of U.S. Pat. No. 5,258,037 to Caspers for a device detailed as PROSTHETIC LINER AND METHOD OF MAKING THE LINER WITH A PROSTHESIS SOCKET. This patent describes a liner that is tight on the amputee's residual limb and big for the receiving socket. Upon donning the liner and wearing the leg, compressive loads force interstitial fluid from the limb and accelerate shrinkage, and atrophy of the limb is the unfortunate characteristic for a total surface bearing liner reduced to prosthetic practice.
There is a need for an approach to immobilize the skin, reducing relative motion, which transfers load and shear to the liner. The approach should contribute to perspiration control, cooling of the residual limb, and improve suspension by limiting pistoning, and assist in daily volume management of the residual limb of an amputee.
In view of the foregoing background, it is therefore an object of the present invention to provide a liner, system and method to immobilize the skin reducing relative motion which transfers load and shear to the liner, control perspiration, cool the residual limb, improve suspension by limiting pistoning, and assist in daily volume management of the residual limb of an amputee.
This and other objects, features, and advantages in accordance with the present invention may be provided by a vacuum assisted liner system for use with a prosthetic device to be attached to a residual limb. The liner system includes a hypobaric prosthetic liner to be donned over the residual limb, and a porous wicking material layer to surround at least a portion of the residual limb and define a regulated vacuum environment between the hypobaric prosthetic liner and the residual limb. The hypobaric prosthetic liner has at least one passageway therethrough defining at least one vacuum port in fluid communication with the regulated vacuum environment.
The hypobaric prosthetic liner may include a sealing apron adjacent a proximal end thereof to create a seal between the hypobaric prosthetic liner and at least a portion of the prosthetic device. Also, the porous wicking layer may be attached to the hypobaric prosthetic liner. The at least one vacuum port preferably includes an inlet port in fluid communication with the regulated vacuum environment and an outlet port in fluid communication with the regulated vacuum environment.
The at least one passageway preferably includes a first internal liner passageway connecting the inlet port to the regulated vacuum environment, and a second internal liner passageway connecting the outlet port to the regulated vacuum environment. A vacuum regulation device may be connected at least to the outlet port, and may include an electric vacuum pump connected to the outlet port, and an associated controller. Furthermore, the vacuum regulation device may include a flow control switch, such as a solenoid valve, connected to the inlet port.
The vacuum regulation device may also include a battery to power the vacuum pump, controller and solenoid valve, and a housing may contain the battery, vacuum pump, controller and solenoid valve. Also, a remote control transmitter may be included for controlling the solenoid valve. A manually adjustable vacuum relief valve may be connected to the inlet port.
The vacuum regulation device may alternatively include a motion actuated vacuum pump connected to the outlet port, and an associated mechanical linkage connecting the motion actuated vacuum pump to the prosthetic device. A non-adjustable vacuum relief valve may be connected to the inlet port of the hypobaric prosthetic liner and in fluid communication with the regulated vacuum environment.
Objects, features, and advantages in accordance with the present invention may be provided by a vacuum assisted liner system for use with a prosthetic device to be attached to a residual limb, wherein the liner system includes a hypobaric prosthetic liner, and a textile fabric layer to define a regulated vacuum environment between the hypobaric prosthetic liner and the residual limb. The hypobaric prosthetic liner has a plurality of passageways therethrough defining an inlet port and an outlet port in fluid communication with the regulated vacuum environment. A vacuum regulation device is connected between the inlet port and the outlet port, the vacuum regulation device including an electric vacuum pump connected to the outlet port, and a solenoid valve connected to the inlet port.
The plurality of passageways may comprise a first internal liner tube connecting the inlet port to the regulated vacuum environment, and a second internal liner tube connecting the outlet port to the regulated vacuum environment. The vacuum regulation device may further include a battery to power the vacuum pump, controller and solenoid valve, and a housing containing the battery, vacuum pump, controller and solenoid valve. Again, a remote control transmitter may control at least the solenoid valve.
Objects, features, and advantages in accordance with the present invention may also be provided by a method of attaching a prosthetic device to a residual limb, the method including providing a hypobaric prosthetic liner, and providing a porous wicking material layer to surround at least a portion of the residual limb and define a regulated vacuum environment between the hypobaric prosthetic liner and the residual limb. The hypobaric prosthetic liner has at least one passageway therethrough defining at least one vacuum port in fluid communication with the regulated vacuum environment. The method further includes providing a vacuum regulation device to connect at least to the outlet port.
The at least one vacuum port may include an inlet port in fluid communication with the regulated vacuum environment and an outlet port in fluid communication with the regulated vacuum environment. The at least one passageway may include a first internal liner passageway connecting the inlet port to the regulated vacuum environment, and a second internal liner passageway connecting the outlet port to the regulated vacuum environment. The vacuum regulation device may include an electric vacuum pump connected to the outlet port and/or a solenoid valve connected to the inlet port.
The vacuum regulation device may further include a battery to power the vacuum pump and solenoid valve, and a housing containing the battery, vacuum pump, and solenoid valve. The vacuum regulation device may further include a remote control transmitter for controlling at least the solenoid valve. The method may include connecting a manually adjustable vacuum relief valve to the inlet port.
The vacuum regulation device may include a motion actuated vacuum pump connected for connection to the outlet port, and an associated mechanical linkage to connect the motion actuated vacuum pump to the prosthetic device. The vacuum regulation device may further include a non-adjustable vacuum relief valve connected to the inlet port of the hypobaric prosthetic liner and in fluid communication with the regulated vacuum environment. Again, the hypobaric prosthetic liner may include a sealing apron adjacent a proximal end thereof to create a seal between the hypobaric prosthetic liner and at least a portion of the prosthetic device.
The many embodiments of the present invention decribed herein immobilize the skin reducing relative motion which transfers load and shear to the liner. The embodiments of the present invention contribute to perspiration control, cooling of the residual limb, and improving suspension by limiting pistoning and assisting in daily volume management of the residual limb of an amputee.
The present invention will now be described more fully hereinafter with reference to the accompanying drawings, in which preferred embodiments of the invention are shown. This invention may, however, be embodied in many different forms and should not be construed as limited to the embodiments set forth herein. Rather, these embodiments are provided so that this disclosure will be thorough and complete, and will fully convey the scope of the invention to those skilled in the art. Like numbers refer to like elements throughout.
Referring initially to
Vacuum is negative pressure (or less than atmospheric pressure) commonly expressed in inches of mercury (″Hg) or millimeters of mercury (mmHg) which is equal to torr. One atmosphere equals 14.7 psia (0 psig), 29.92″Hg (0″Hg absolute), 760 mmHg, 760 torr or 1,013 mbar.
The hypobaric prosthetic liner 3 is to be donned over the residual limb 4, and the porous wicking material layer 5 surrounds at least a portion of the residual limb and defines a regulated vacuum environment between the hypobaric prosthetic liner and the residual limb. Passageways are defined by the vacuum inlet and outlet ports which are in fluid communication with the regulated vacuum environment.
It should be noted that the wicking action of the thin prosthetic sock 5, which allows air to flow through it, is the mechanism by which the air inlet 90 and outlet 105 are in communication with each other and allows inflowing air and maintained vacuum to cool the residual limb 4. Although a below knee residual limb is represented in
When air is removed from inside the liner 3, atmospheric pressure pushes the skin of the residual limb 4 and the inside of the liner 3 into tight adherence. This results in the transferring of load and shear and minimizing pistoning of the liner relative to the residual limb 4. It should be pointed out that there is no increase in radial compression of the liner upon the residual limb because of the application of regulated vacuum. There is, however, a dramatic increase in intimate contact between the liner and the residual limb. It should also be noted that the application of regulated vacuum to the inside of the liner does not engender edema in an ideally working system. Again, vacuum draws the liner and the skin into tight adherence.
Creating an elevated vacuum environment between the limb 4 and liner 3 will evaporate the most energetic molecules of perspiration on the residual limb. Adding a mass air flow mechanism accomplished by the vacuum source and the inlet 90 evaporates the perspiration with increased rapidity because of the inflow of air. Elevated vacuum, by lowering saturation vapor pressure, increases the tendency of water to overcome its surface tension and evaporate, which is an endothermic (net heat loss) reaction. The system represented by
Referring to
It should be noted that the prosthetic sock 5 can be replaced by a design encompassing an integrated breathable fabric or membrane attached or bonded to the inside of the liner 3. A bonded breathable fabric serves the same function as the removable prosthetic sock 5, distributing vacuum, removing perspiration and allowing communication between the checked inlet 90 and the checked outlet 105. It may however be desirable to have the ability to remove the prosthetic sock 5 from the liner for hygienic purposes as it also serves as a filter for the pump system capturing dirt particles and mineral deposits. It should also be pointed out that the liner 3 can be manufactured using urethane, silicone, thermoplastic elastomer, RTV rubber or any appropriate material.
The vacuum level established inside the hypobaric prosthetic liner 3 may be tailored to each patient. The minimal amount of negative pressure to hold the liner 3 on is a function of the weight of the prosthesis divided by the cross-sectional area of the residual limb 4 near the distal end. For example, a below knee patient might require −0.736 PSI to hold their liner and leg on or 1.5″Hg vacuum. A vacuum level of 3″Hg vacuum would be chosen as the vacuum level inside the hypobaric prosthetic liner 3 to achieve a safety factor of 1 (unity). In an average above knee (AK) limb, a zero safety factor would be 3″Hg. Given that most of the problems with elevated vacuum in an artificial limb occur around the popliteal fold (back of the knee), an AK limb on a healthy patient would be able to tolerate 6″Hg if the inside sock were tapered proximally with a band of thin silicone, for example, as detailed in the prosthetic sock 5 shown in
The chosen vacuum level between the limb and hypobaric prosthetic liner is preferably a clinical judgment of the attending prosthetic practitioner. For example, diabetic patients have thin glassy skin subject to breakdowns. Given the unquantifiable aspect of radial compression and frictional adhesion holding the liner on the residual limb, the safety factor of maintained vacuum between the limb and liner could be lowered in view of protecting delicate tissue. The higher the maintained vacuum level inside the liner, the greater the detrimental effect of problems resulting from the system not functioning perfectly. An example of non-optimal functioning of the system would be wrinkles caused by bending the knee, unintentional gaps or holes in the sock 5, unnoticed curling of the proximal edge of the sock. Each of these occurrences can damage the skin at higher vacuum levels. Accordingly, it is preferable, based upon clinical judgment, that the vacuum level should not exceed 10″Hg between the limb and the hypobaric prosthetic liner. In general, the vacuum level above the minimal amount to hold the limb on, as represented by a safety factor of 1 (or double the minimal amount) improves adherence of fit, evaporation of perspiration, maintenance of daily volume, immobilizes the skin, which reduces the relative motion and transfers load and shear to the liner.
Referring now to
When the appropriate keychain radio transmitter 107 button is pushed, the solenoid valve changes state and opens, allowing air to in flow between the residual limb 4, sock 5, and liner 3. Simultaneously, the vacuum pump 111 controlled, for example, by a pulse width modulation chip on the circuit board 110, maintains a constant RPM effectively pulling air though the system that includes the residual limb 4, sock 5 and liner 3. Technically, air is not actually pulled through the defined system; it is pushed by atmospheric pressure. When the appropriate keychain radio transmitter 107 button is pushed, the solenoid valve changes state and closes, and the system is closed and the maintained and regulated vacuum level is restored.
This configuration can be used on above-knee, below-knee and upper-extremity amputees. The below knee artificial limb illustrated in
A rechargeable lithium battery 112, for example, is the power source for the electronics contained in the enclosure 106. A car cigarette lighter adaptor may also be included with the design to recharge the batteries while traveling. The electric vacuum pump 111, associated controller 110, flow control switch or solenoid valve 109, battery 112, housing 106 and remote control transmitter 107 may define a vacuum regulation device.
The illustrated hose lines 113, 12 may use 0.0625″ ID or 0.040 ID flexible tubing. The smaller ID tubing minimizes noise of the vacuum pump as well as limits the amount of dead air space needed to be removed from the system, making the operation of the vacuum pump more efficient. Internal vacuum passageways 58 may be made from the same tubing cast in the liner 3.
Illustrated in
It is entirely possible that higher levels of automation may be required to address individual patient needs. A closed system moisture/humidity sensor may augment or replace the keychain remote function of initiating the boost flow of cooling air through the typically closed limb 4, sock 5, and liner 3 system. An ambient air humidity sensor maybe added to automatically adjust the vacuum level inside the limb 4, sock 5, and liner 3 system. A temperature sensor could also be used for this function, as the temperature inside the liner (relative to ambient air) rises, the pump could go through a vacuum/air flow boost cycle, rapidly cooling the limb. An accelerometer could also be used so that as relative motion (i.e. an increase in activity) increases, the vacuum level could be raised and cooling take place. A vacuum sensor actuating a solenoid valve may also be employed, defining a vacuum regulation device.
Depicted in
There is an optional mesh filter 114 that covers the entry point for the proximal tube 113, and although not illustrated, there may be other optional mesh filters that cover, for example, the distal entry point of vacuum on the inside of the liner 3. The mesh filters 114 act as a crude filter for the vacuum pump and prevent potential window edema given the thin ply prosthetic sock 5. A quick detachable tube locking mechanism and fine filter 108 may be located in the external tube lines 12, 113. The electric vacuum pump system maintains an adjustable and regulated vacuum inside the prosthetic liner 3 with solid state or microprocessor controls found on the ultra low power, radio control receiver, encoder and driver and function circuit board 110 located in the enclosure 106. This configuration can be used on above-knee, below-knee and upper-extremity amputees.
When the appropriate button on the keychain radio transmitter 107 is depressed, the radio control receiver 110 initiates a signal that increases the RPM of the motor, raising the vacuum level, activating the vacuum relief valve that allows air to flow through the system, rapidly cooling the stump. Air enters the system in
Depicted in
An optional feature to this embodiment allows atmospheric air to be introduced into the liner by the user via a wick 83. The wick can be a cut piece of prosthetic sock, a section of yarn or any breathable material that will allow air to enter the system that comprises the limb 4, sock 5, and inside hypobaric prosthetic liner 3. The wick 83 can be tucked away in the liner, allowing a homeostatic elevated but regulated vacuum to exist in the closed system. When the wick is extended by the user, so that it protrudes beyond the proximal border of the liner 3, and in communication with the outside air, the vacuum pump 111, turns on and a rapid inflow of air occurs into the now open system. Control of the surface area of the wick 83, in regards to the mass capacity of the pump, will also maintain an elevated vacuum in the system. When sufficient cooling has been achieved, the user tucks the wick back into the liner and the system is closed and a maintained vacuum level is restored. This described configuration can be used on above-knee, below-knee and upper-extremity amputees.
Although the use of elevated vacuum applied to the outside of a prosthetic liner and the socket is known, the present invention includes the application of vacuum to the inside, or a combination of both inside and outside, as detailed in forthcoming embodiments. The Vacuum Assisted Heat/Perspiration Removal System and Limb Volume Management for Prosthetic Device is not limited to a pin suspension. Although not illustrated in the various embodiments, it should be noted that between the outside of the liner 3 and the socket 2, a nylon, or sock can be worn for comfort and for ease of inserting the limb and liner into the socket.
Depicted in
For example, such a motion activated pump can be found in U.S Pat. Application Pub. No. 2005/0143838 to Collier described as VACUUM-ASSISTED PROSTHETIC DEVICE. Careful reading of the patent reveals that Collier's method draws elevated negative pressure to the inside of the prosthetic socket and on the outside of the prosthetic liner. Collier's system is designed to be used with a specific foot
The embodiment or the present invention draws elevated negative pressure to the inside of the prosthetic liner 3 between the limb, sock, and liner system as described previously. The embodiment presented here is also modular and designed to fit on various limbs, sockets and feet available in the marketplace. The base plate 120 that the air cylinder configured for vacuum generation is bolted to has, for example, four oblong holes 122 (two of the holes are not shown) so the relative placement of the air cylinder configured to create sub-atmospheric pressure can be adjusted, increasing and decreasing the lever arm from the axis of rotation, resulting in increased pull on the piston rod 11). This adjustability prevents off axis loading when different prosthetic feet 72 are employed and adapts to the limits of plantar flexion and dorsiflexion of the various prosthetic feet used. For example, the longer the lever arm is from the center of rotation, the less dorsiflexion and plantar flexion needed to achieve full stroke length of the piston in the air cylinder configured to create vacuum. Attached to the heel of the prosthetic foot 72 with low profile hook and loop with high shear pressure sensitive adhesive is 0.5″ Dacron webbing and a cable hanger 115. Attachment of the Dacron webbing and cable hanger 115 to the shoe is another possibility that would in effect increase the lever arm further from the axis of rotation, resulting in increased pull on the piston rod 119. Stainless steel aircraft cable 116 is connected to a ball receiver that is connected to a ball terminal 118, which is in turn connected to the rotating piston rod 119 in the air cylinder configured for vacuum generation 125.
The air cylinder is configured for generating negative pressure by employing low cracking pressure check valves. The air logic diagrams of check inflow and checked outflow are on either end of the illustrated tee 124. The air cylinder is outfitted with four tie rods 123. The advantage of the tie rod design is that the overall height of the cylinder can be customized to each individual prosthetic foot which is another modular feature. A clamping screw 121 allows the device to be adjustable up and down the pylon 38. A flexible cable 116 connects the foot 72 and the piston rod 119 of the air cylinder configured to generate vacuum. If a rigid linkage was employed instead of the flexible cable 116, vacuum could be generated in both the down pull on the piston rod 119 and the return stroke. Outfitted with a spring return, vacuum is generated only on the pull stroke.
A tiny, lightweight, spring loaded vacuum relief valve is attached to the proximal aspect of the liner 126. This non-adjustable vacuum relief valve 90 is employed to allow air flow inside the prosthetic liner while maintaining a therapeutic vacuum level inside the liner. The use of a non-adjustable vacuum relief valve 90 is best suited for a body powered vacuum pump 125 as the mechanism is not sufficiently accurate enough or exactly repeatable in its vacuum cracking pressure to work well with a battery powered vacuum pump with electronic controls. It should be noted that the non-adjustable vacuum relief valve 126 is well within tolerances for use with the illustrated air cylinder configured for vacuum use 125.
Vacuum is generated with each step; just before foot flat and toe off in the human gait cycle, the shaft 119 of the air cylinder is pulled downward, and air is drawn in from the spring loaded vacuum relief valve 126 which is in communication with the prosthetic sock 5. The prosthetic sock 5 distributes vacuum over the limb and when a set vacuum level is achieved, the vacuum relief valve opens and air is pulled through the liner 3, rapidly evaporating moisture and cooling the limb 4. By the function of the relief valve, a vacuum level is maintained inside the liner 3 as air is constantly streaming in. Air is drawn in between the limb 4 and liner 3 flowing out through the internal vacuum passageway in the liner, out through the external vacuum tubing 12 and into the air cylinder configured as a vacuum pump 125. After toe off and immediately after heel strike, the spring return piston retracts completely eliminating any dead air space, which is expelled via the checked outflow mechanism connected to the tee 124 and the cycle begins again.
The importance of vacuum inside the liner 3 is that it reduces relative motion between the limb and liner, it wicks away moisture and keeps the limb cool. This is important to amputees with vascular complications (e.g. stemming from diabetes) because temperature regulation is a function of circulation cooling the limb, which in such cases is compromised by disease. Heat, perspiration and pressure are leading causes of tissue maceration and wound healing is impeded by dyvascular complications. There is strong research evidence of the efficacy of vacuum assisting in wound healing. The application of vacuum inside the prosthetic liner draws the liner and the skin into tight adherence. There is no compression of the stump nor is there any tendency for edema. The pressure loading of the skin is transferred to the liner because relative motion has been eliminated by the addition of regulated vacuum between the stump and liner. This configuration can be used on above-knee, below-knee and upper-extremity amputees.
Depicted in
The vacuum configured air cylinder is connected to the distal tubing, or vacuum passageway 12, which is in communication with the internal vacuum passageway 58, and also in communication with the thin prosthetic sock 5, which acts as a wick and distributes regulated vacuum to the amputee's limb 4. Vacuum supplied to a prosthetic limb with this configuration achieves volume management, perspiration removal, cooling of the stump and minimizing of pistoning. Also achieved is the benefit of the skin being immobilized, thus loads and shear being transferred to the liner. The optional feature of allowing atmospheric air to be introduced into the liner by the user via a wick 83 as described above, can also be used herewith.
The knitted prosthetic sock 5 described in this application is not an osmotic membrane, it assists in removing heat and perspiration by allowing distribution of vacuum over the residual limb and communicating between the checked inlet 90 and checked outlet 105 mechanism schematically represented in
The design schematically represented in
It should be noted that designs presented here preferably do not have any prosthetic wicking sock closer then 2″ from the proximal border of the liner. This is done to maintain a redundant vacuum seal on the limb as well as the understanding that the distal areas of the residual limb is where problematic perspiration builds up. It should also be noted that all the vacuum pump designs presented in this application only deliver sub-atmospheric pressure to the inside of the prosthetic liner. In forthcoming embodiments, the Hypobaric Prosthetic Liner will be shown being adapted to designs that have elevated vacuum to the outside of the prosthetic liner (not the inside). Some of the embodiments presented employ vacuum pumps that are commercially available.
The vacuum passageways are made with small ID flexible tubing placed in the Hypobaric Prosthetic Liner mold before filling. Suspension of the Hypobaric Prosthetic Liner 3 is solely a mechanical interface of the locking pin 59 and shuttle lock in the socket (not illustrated). The shuttle lock secures the pin via many different methods and releases the pin with a push button mechanism (not illustrated). The advantage of using a pin suspension is the ease and simplicity of the configuration as well as the increased range of knee motion achieved with the removal of the traditional suspension sleeve or other sealing mechanisms. In pin-lock systems, a problematic phenomenon known as pistoning occurs. Pistoning is when distal distraction of the liner occurs because of the weight of the prosthetic limb, which is borne on the distal locking pin. This can cause discomfort, edema, skin irritation and abrasion. When regulated elevated vacuum is applied to a pin lock prosthetic liner, pistoning is minimized, the skin is immobilized, transferring loads and shear from the skin to the liner.
This embodiment allows the use of a custom prosthetic sleeve 28 and an expulsion valve 86 employed to suspend the limb. The vacuum tubing 12 connects to a vacuum source, either the battery power pump 106, as found in
A prosthetic sock (not illustrated here) distributes regulated vacuum to the limb of the amputee. An external vacuum passageway 12 connects to a vacuum source. So long as the distal internal vacuum port 57 interfaces with the vacuum distributing sock, there is no reason why it has to be specifically located at the distal center of the prosthetic liner. It could be located anywhere proximally up the walls of the prosthetic liner 3. It should be pointed out that there is no reason as to why this configuration could not be used with a traditional solid pin lock liner as depicted in
Depicted in
Air pulled by the vacuum source attached to passageway/hose 12, travels through the a given insert, up the hose/passageway 128 into the first proximal external vacuum port 56 down the internal passageway and out the internal proximal vacuum port 57 distributed over the limb by the thin prosthetic sock (not pictured) down through the distal internal vacuum port 57 and up the internal vacuum passageway 58 and out the second proximal external vacuum port 56 and down the external passageway/hose 12 towards the vacuum source. This configuration can be used on above-knee, below-knee and upper-extremity amputees.
A custom manufactured suspension sleeve can be manufactured from a patient's custom measurements. Suspension sleeves are in common practice in prosthetic limb designs, and can be basically described as an elastic tube which covers the socket and a part of the amputee's limb. In an elevated vacuum suspension artificial limb design, a suspension sleeve provides redundant suspension, connecting the prosthetic socket and liner via frictional adhesion, as well as a vacuum seal between the limb and the socket. It is important to understand that traditional suspension sleeves, employed in an elevated vacuum or hypobaric sockets, are of standard stock dimensions and not customized to the patient's limb and liner. A suspension sleeve 28, such as illustrated in
The apron or curtain 1 is employed to minimize vacuum leakage on systems that employ elevated vacuum to the outside of the prosthetic liner and it assists in providing positive suspension for the prosthesis. The Apron/Curtain is hermetically bonded or molded or adhered to the prosthetic liner 3 creating a monolithic airtight structure, i.e. integrally formed. The
Referring to
The liner and socket design of
The liner and socket design of
The stretch and elongation of the material employed in the prosthetic liner, be it urethane, silicone, thermoplastic elastomer, or RTV rubber, allows the curtain/apron to be pulled over the prosthetic socket 2 and conform, creating an airtight seal. Again, the apron or curtain can either be permanently bonded or stuck together with a special high bond tacky silicone, allowing the curtain or apron to be removable. The objective of the apron or curtain is to create an air tight seal proximally on the prosthetic socket. If the vacuum seal is ever compromised, the curtain suspends the prosthetic socket via frictional adhesion. This configuration can be used on above-knee, below-knee and upper-extremity amputees.
It is worth noting that a traditional suspension sleeve employed in an elevated vacuum or hypobaric socket has two potential leak areas. One leak path occurs distally where it clings to the socket, and the other occurs proximally on the amputee's skin. Clinical experience indicates that off the shelf, standard sized suspension sleeves are difficult to don, limit knee flexion, are excessively tight on the skin and provide at best, a leaky vacuum seal. The curtain/apron embodiment of the Hypobaric Prosthetic Liner addresses of these problems.
As depicted in
Referring to
Tension or reduction values are a common reference in the manufacture of a prosthetic socket or liner. It refers to the difference between the patient's limb circumferential measurements and the positive model that is used to create a custom prosthetic liner or socket. Although the Hypobaric Prosthetic Liner 3 can be either of custom measurements or standard average sizes, there are advantages to custom molding of the curtain or apron. Using custom measurements allows a minimal amount of compression to be used in suspending and sealing the prosthetic limb. Under 0.5″ PSI of compression caused by the preload of the liner will be the stated objective of the Hypobaric Prosthetic Liner, as research has shown this to be the maximum amount that tissues can tolerate without shrinking.
A commercially available vacuum pump 10 of any configuration (body powered or battery operated) delivers vacuum to the outside of the prosthetic liner 3 via flexible vacuum tubing 9 connecting to the prosthetic socket 2, which is a standard practice in prosthetics. It is important to note that elevated vacuum applied to the outside of the Hypobaric Prosthetic Liner 3 is achieved by commercially available vacuum pumps. The unique vacuum pump systems presented previously in this application only deliver vacuum only to inside of the liner 3. This design branches off a line of vacuum going to the socket 2 and delivers it to the inside of the liner 3. As illustrated, a small adjustable vacuum regulator 11 delivers regulated elevated vacuum via the flexible vacuum tubing 12 to the hollow locking pin 59 secured in the shuttle lock 18 of the socket 2. This design is not limited to a hollow suspension pin 59 as forthcoming embodiments will illustrate.
Referring to
A prosthetic sock 5 designed to be worn between the stump and the liner is employed as a sweat wicking sock in the Hypobaric Prosthetic Liner 3, which allow vacuum to be distributed evenly over the limb 4. Although these socks are designed to be worn between the skin and the liner, the use as a sweat wicking sock, as well as for vacuum distribution, is unique to the Hypobaric Prosthetic Liner of the Vacuum Assisted Heat/Perspiration Removal System and Limb Volume Management for Prosthetic Device design. Regulated vacuum between the liner and the skin, assists in minimizing volume loss by bringing the liner and the skin in tight adherence, which, during swing phase, causes distal traction of the tissues relative to the bones of the stump, and facilitates interstitial refill of the limb. It also assists in removal of perspiration, immobilizes the skin, and transfer load and shear to the liner.
Referring to
Another observation of the application of both vacuum to the inside of the liner and the outside is that it creates the desirable situation of greater amputee control and feedback from the limb. The application of vacuum to the inside and outside of the liner draws the flexible liner tightly to the walls of the socket, eliminating pistoning or elongation of the liner inherent during swing phase of the amputee's gait. This configuration can be used on above-knee, below-knee and upper-extremity amputees.
The liner and socket design of
An electronic vacuum regulator may be necessary with liners and limbs configured as illustrated in FIG. 15B. Although not currently illustrated, an electronic vacuum regulator would overcome the potential mass flow limitations of the manually adjustable vacuum regulator 11. The mass flow limitations only becomes an issue in designs that have a relief valve in that an open flow of air is needed for cooling and traditional vacuum regulators restrict flow. A solenoid valve in conjunction with a vacuum sensor and driver board overcomes the mass flow restrictions of typical vacuum regulators. In both versions a nylon or prosthetic sock 8 is on the outside of the prosthetic liner 3 and distributes negative pressure to suspend the prosthetic on the liner. This configuration can be used on above-knee, below-knee and upper-extremity amputees.
Depicted in
Although not illustrated, a thin prosthetic sock is employed in this embodiment between the stump and the liner. Filtering screens 30 protects the check valve from clogging. Mineral deposits from perspiration are also filtered by the prosthetic sweat sock. Another feature of this vacuum regulator design will be the feature to compress or lessen the spring tension of the regulator, which will raise or lower the cracking pressure of the regulator. The sock (not illustrated) is a removable thin ply prosthetic sock that distributes vacuum between the inside of the liner and the stump. This configuration can be used on above-knee, below-knee and upper-extremity amputees.
In the prior art there is an example of a prosthetic liner fitted with a check valve. U.S. Pat. No. 6,544,292 Laghi describes a device as PROSTHETIC LINER WITH INTEGRAL AIR EXPULSION VALVE. This patent depicts a prosthetic liner with an air expulsion valve built into the walls of the liner, to facilitate donning of the limb and creating an airtight seal upon the limb. There is no mention of perspiration removal or its application with elevated vacuum. There is also no prosthetic sock donned between the limb and liner in Laghi's design so that air expulsion would not be as effective, or complete as if used with a prosthetic sock.
Illustration
Illustration
Depicted in
Depicted in
Depicted in
Depicted in
Depicted in
A rigid sock frame 131 made from thin PETG or laminated Dacron or urethane is created so that a thin sock can be adhered to it and folded over its proximal edges. The hole is cut out for the expulsion valve and the sock pulled through and reflected and glued around the exterior of the hole. Hook and loop suspend the rigid insert 131 into the socket 2. Other suspension techniques could be employed to give a secure purchase for the insert as well as facilitate its removal. A pin lock or a lanyard system could be employed to secure the rigid sock frame 131. Given careful fabrication techniques the structure becomes monolithic inside the socket without any noticeable ridges that may abrade the stump of the amputee. A vacuum source is attached to the vacuum tubing 12 and connected to the socket. Vacuum ports 132 in the rigid structure 131 are reinforced with mesh screens to prevent window edema. A series of inserts (described in
Depicted in
A prosthetic socket with liner 3 is an excellent insulator (or a poor conductor of heat). Heat and moisture are an excellent environment for bacteria. These designs address this problem by allowing air to free flow through the liner 3 and thus cool the limb.
Illustration 28A depicts a pin lock prosthetic liner 3 with a vacuum port 7 through the suspension pin. There is a sweat sock 5 that acts to wick and distribute the air flow. The surface area/micro structure of the wetable sweat sock 5 promotes evaporation of moisture. Water being evaporated is an endothermic reaction where heat is absorbed. A proximal air port 85 is unregulated and allows air to flow into the liner when drawn by a vacuum source (body powered would be most practical for this application). The sweat sock allows air to flow over the limb out to the distal vacuum port 7.
Illustration 28B depicts a pin lock prosthetic liner 3 with a vacuum port 7 through the suspension pin. An air wick 83, which draws in atmospheric air when positioned above the proximal aspect the liner, is in physical contact with the sweat sock 5. This configuration allows for a free flow of air through the prosthetic liner. This setup can also be used in systems that maintain vacuum inside the liner as well as free flow of air through the liner (as depicted in
Illustration 28C depicts the use of sleeve with an air vent. A prosthetic curtain or apron configuration could also be used here. This illustration shows that the design is not limited by the use of a prosthetic apron/curtain or a sealing sleeve. What is not pictured is the prosthetic socket that has a vacuum source attached. The prosthetic sleeve 28 adheres to the limb of the amputee and the proximal aspect of the rigid socket. Allowing the mechanical adhesion of the prosthetic liner to suspend the limb, air could be introduced inside the liner at the air vent 84 in the prosthetic suspension sleeve and pulled through the wick 83 and sweat sock 5 by a vacuum source (e.g. body powered would be most efficient). Regulation of the amount of air flow and retained vacuum level inside the open system will be a function of the size of the air vent 84. This configuration can be used on above-knee, below-knee and upper-extremity amputees.
Referring to
“Seal In” liners employ a fabric covering, but the addition of a short nylon sheath or very thin limb sock 43 may be needed to distribute vacuum over the area below the HSM and thus allow vacuum to be distributed through the vacuum port 41 and to the distal limb. Regulation of the vacuum will be achieved by the use of a vacuum regulator if a mechanical pump is employed (or a vacuum sensor of a battery operated vacuum pump). When regulated vacuum is applied to the limb, air is removed from inside the liner and atmospheric pressure holds the skin of the amputee and the inside of the liner in tight contact. Again, it should be pointed out that there is no increase in radial compression of the liner upon the limb because of the application of regulated vacuum. There is, however, a dramatic increase in intimate contact between the liner and the limb. Volume management is maintained in a limb of such configuration because during swing phase, the weight of the artificial limb and angular acceleration pull on the liner which is in tight adherence with the limb, because of the application of vacuum, causing traction of the distal tissues relative to the tibia, which increases the average volume of distal tissue, creating negative pressure inside the limb, resulting in interstitial refill.
It should also be noted that wicking of perspiration is achieved in this alternative embodiment, as well as a cooling effect on the limb which is a result of the vaporization or evaporation of perspiration. A vacuum pump of any particular configuration is uniquely employed in the drawing of vacuum to the inside of the liner for perspiration control, cooling and volume management, and reduction of movement of the liner relative to the distal tissue, as well as the transference of shear from the skin to the prosthetic liner as the skin will be immobilized. It should be noted that any hybridization of this design can be achieved with the various embodiments of the Hypobaric Prosthetic Liner presented. Although a vacuum relief mechanism is not illustrated, this feature could be added to the design. This configuration can be used on above-knee, below-knee and upper-extremity amputees.
Depicted in
Depicted in
Depicted in
The non-adjustable vacuum relief valve 90 is set to open at a set vacuum level and as the vacuum level rises from the vacuum source (body powered would be the most efficient in this setup), the differential vacuum level supplied by the constant differential valve 31, eventually raises to a level that opens the vacuum relief valve. This results in the maintenance of a set vacuum level inside the liner while allowing a steam of atmospheric air into the closed system to cool the limb. Air enters into the inside of the liner through the non-adjustable vacuum relief valve 90, travels down a sweat sock (not pictured) out through the constant differential valve 3), is wicked along the nylon sheath 8 through the hose barb 9 connected to the socket 2 and out the hose/vacuum passageway toward the vacuum source (not pictured). A wedge shape gasket 91 is employed in sealing the outside of the liner 3 to the socket 2. The wedge shape is pulled tight under vacuum, and thus increases its sealing ability when exposed to vacuum. This configuration can be used on above-knee, below-knee and upper-extremity amputees.
Depicted in
A pull string 64 is looped over the shoulder of the sealing button 63, fed through the prosthetic socket 2 at the receiving passageway hole 65. The pull string assists in pulling the shoulders of the sealing button through the socket 2 creating an air tight seal. It should be noted that the sealing button is not a suspension mechanism, but only a sealing mechanism. The air tight seal allows the use of a sealing sleeve, or bonded apron/curtain to suspend the prosthetic device, with an expulsion valve or even elevated vacuum to the outside of the prosthetic liner or any other desired suspension mechanism. Although a vacuum relief mechanism is not illustrated, this feature could be added to the design. This configuration can be used on above-knee, below-knee and upper-extremity amputees.
The vacuum port 60 is formed in such a way that the flexible tubing vacuum passageway 51 can be removed from the liner 3 and reattached when the liner in seated in the prosthetic socket 2. A captured four lobed O-ring may be employed in the sealing plug to create an airtight seal on the flexible tubing vacuum passageway 51. Although a vacuum relief mechanism is not illustrated, this feature could be added to the design. This configuration can be used on above-knee, below-knee and upper-extremity amputees.
The vacuum passageway 51 ultimately connects to a vacuum source and the sweat sock 5 acts as a wick distributing vacuum between the inside of the prosthetic liner 3 and the limb. The sweat sock employed with this design is a removable thin ply prosthetic sock. A specifically modified nylon or prosthetic sock worn on the outside of the liner should be included to allow for the vacuum passageway 51. Although a vacuum relief mechanism is not illustrated, this feature could be added to the design. This configuration can be used on above-knee, below-knee and upper-extremity amputees.
Depicted in
A double wall kit, for example as would be appreciated by those skilled in the art, can be used for this specific application. The Double Wall Kit can be assembled so that it brings vacuum from a source outside the socket 2, to inside the Hypobaric Prosthetic liner 3. The kit, e.g. from Otto Bock, supplies a hollow locking pin, means for making an air tight shuttle lock by employing a double sealing O-ring against a smooth (and hollow) pin and an attachment plate ported for vacuum. The attachment plate in this double wall kit is configured in such a way as to create a clear air passageway to a hose barb outside the rigid socket 2. In this embodiment, the socket attachment plate is used to deliver vacuum to the inside of the Hypobaric Prosthetic Liner 3.
An illustration of such a double wall kit can be found in U.S. Pat. No. 6,926,742 to Caspers described as PLATE/SOCKET ATTACMENT FOR ARTIFICIAL LIMB VACUUM PUMP. It is important to note that this patent only teaches the delivering of vacuum to the inside of a rigid socket and not to the inside of a prosthetic liner containing a prosthetic sock and limb.
The Vacuum Assisted Heat/Perspiration Removal System and Limb Volume Management for Prosthetic Device design is not constrained to the pin lock suspension as evidenced by the embodiments herein. The liners presented can be custom configured to a patient's limb measurements or have standard sizing regarded as “off the shelf” liners. One advantage of a custom prosthetic liner 3, in whatever embodiment, is that it does not have to have a uniform wall thickness. Specific buildups in regions that are sensitive on the limb can be molded in the liner. The fibular head, the distal tibia and tibial crest all have received additional liner material, achieving extra cushion for specific anatomical areas. Weight reduction of the liner is achieved by not having a uniform thick prosthetic liner. These embodiments can be used on above-knee, below-knee and upper-extremity amputees.
Referring to
The illustrated sweat sock has a tapered proximal ply of material beginning at the transition line 19. The reduced ply of material found in the proximal band creates a gently tapered shape. The top of the liner 21 is sewn with a smooth elastic selvage to prevent fraying of the thin ply material. An alternative to the selvage line is a 0.75 inch band of silicone applied to the top of the sweat wicking sock 5, beginning at the transition line 19 and extending approximately 0.75 inch to the top of the sock 21 which helps to control rolling or curling of the proximal aspect of the sock. This top silicone band can be cut in a serpentine fashion to afford extra protection to the skin of the amputee. The added protection of a silicone band is more important to the designs that have elevated vacuum applied to the inside of the prosthetic liner as slightly higher vacuum levels are required to achieve cooling and perspiration removal in such configurations. With the higher vacuum, the more critical is the smooth interface of the prosthetic sock 5 inside the liner.
The purpose of the tapered proximal ply or silicone band is to create a smooth transition between the limb, the sweat sock and the Hypobaric Prosthetic Liner. The smooth transition ensures that the delicate skin of the amputee's limb will not be abraded or damaged by the sweat wicking sock when exposed to regulated vacuum and the dynamic forces created when walking in a prosthetic device. The sweat wicking sock 5 as illustrated is a removable thin ply prosthetic sock. It should be noted that the design of an integrated breathable fabric or membrane bonded to the inside of the liner is also contemplated in the various embodiments of the Hypobaric Prosthetic Liner. It is however desirable to have the ability to remove the sock from the liner for hygienic purposes as it also serves as a filter for the pump system capturing dirt particles and mineral deposits.
Although not illustrated, the sock 5 can also be cut on an angle to cover the knee of a below knee amputee but leave the politeal fold uncovered by the sock. Detrimental wrinkles occur at the back of the knee if the sock is lost its elasticity. When wrinkles occur, localized edema occurs and there is a potential for skin damage. Cutting the sock on a angle leaves the politeal fold open, removing the potential for wrinkles.
The Hypobaric Prosthetic Liner, coupled with a prosthetic vacuum pump, effectively eliminates limb volume fluctuations. Therefore, the prosthetic sweat wicking sock performs different functions when employed with the Hypobaric Prosthetic Liner. Although there are commercially available prosthetic socks designed to be worn under a prosthetic liner, the sweat wicking prosthetic sock differs significantly in function. The main function of the prosthetic sweat sock is to act as a wick allowing perspiration to be drawn away from the limb and expelled from the prosthetic device via vacuum. The prosthetic sweat sock also acts as a means of even vacuum distribution as well as a cushion, distributing external localized pressure over a broader surface area of the limb. Again, the prosthetic sock also acts as filter trapping dirt and mineral deposits from perspiration.
Many modifications and other embodiments of the invention will come to the mind of one skilled in the art having the benefit of the teachings presented in the foregoing descriptions and the associated drawings. Therefore, it is understood that the invention is not to be limited to the specific embodiments disclosed, and that modifications and embodiments are intended to be included within the scope of the appended claims.
This application claims the benefit of U.S. Provisional Application Nos. 60/715,313 filed Sep. 8, 2005, 60/724,512 filed Oct. 8, 2005, 60/749,942 filed Dec. 12, 2005, 60/759,327 filed Jan. 14, 2006, 60/760,074 filed Jan. 18, 2006, 60/760,596 filed Jan. 21, 2006, 60/777,240 filed Feb. 27, 2006, 60/798,533 filed May 08, 2006, 60/833,368 filed Jul. 26, 2006 and 60/837,805 filed Aug. 14, 2006, all of which are hereby incorporated herein in their entireties by reference.
| Number | Date | Country | |
|---|---|---|---|
| 60715313 | Sep 2005 | US | |
| 60724512 | Oct 2005 | US | |
| 60749942 | Dec 2005 | US | |
| 60759327 | Jan 2006 | US | |
| 60760074 | Jan 2006 | US | |
| 60760596 | Jan 2006 | US | |
| 60777240 | Feb 2006 | US | |
| 60798533 | May 2006 | US | |
| 60833368 | Jul 2006 | US | |
| 60837805 | Aug 2006 | US |
