Patent Application
20180071117
The present invention relates to the field of prosthetics and supporting devices for amputees.
Prosthetics are often suspended to the amputated limb (residuum) a prosthetic socket by various means. Prosthetics can be held in place in a number of ways, including with shuttle lock systems, suction systems, and vacuum systems. Prosthetics can be designed with a specified level of activity in mind. Prosthetics designed for greater activity require greater attention to detail when fitting the prosthetic to a limb. One way of achieving a snug, consistent, and reliable fit for the enhanced suspension of a prosthesis is by donning the prosthetic limb and then integrate either a standard static suction (e.g., 0 atmosphere) system or a high negative vacuum (−1 to −23 in. Hg) system between a prosthetic inner socket and the amputated limb, thereby forming an integral connection and an air-tight seal between the two. Prior art systems for achieving this vacuum or suction are inadequate and improvements are needed. Embodiments of the inventions described herein solve problems of the prior art and, among other things, allow for the improved fitting, ease of use and unrestrictive diurnal application of a prosthetic by the user without the need of intervention from a medical professional, such as a prosthetist, to help maintain functionality of current, less robust and less reliable valve systems.
Embodiments of a prosthetic valve as described herein may comprise a valve plug assembly and housing comprising: a valve housing comprising: a valve body; and a locking ring; a valve plug assembly comprising: a finger grip portion; a barb; a cylindrical portion protruding from the finger grip portion wherein the cylindrical portion is configured to fit inside of and create an airtight seal with the valve body; and at least one o-ring. In some embodiments a valve plug assembly may comprise an upper o-ring; and/or a lower o-ring. In some embodiments, a barb can be a 360 degree rotatable barb, wherein the barb is rotatable relative to a finger grip portion of a valve plug assembly. In some embodiments a barb can be a 90 degree barb, a 45 degree barb, or other angle, which is not particularly limited and such angles would be envisaged by the skilled artisan. A finger grip portion may be circular along its outer diameter. In some embodiments, a finger grip portion is not hexagonal.
An embodiment of the present invention comprises a one-way air expulsion plug device that can be manually inserted into a valve body, wherein the valve body can be a plastic or similar material. In some embodiments, the invention comprises a double O-ring stem that can rotate, a larger circumference top, a 360 degree rotatable barb that can connect via a hose, preferably a flexible hose, to an external vacuum system, electronic or manual, for suspending a prosthesis by, for example, evacuating air, attaching, and/or sealing a prosthetic limb to an amputee for various amputation levels. In certain embodiments, the invention comprises a stem portion that mates with the valve body. In other embodiments, a stem portion comprises a snap mechanism or a click mechanism for mating with the valve body. Embodiments of the invention comprising a one-way air expulsion plug device provide the unexpectedly superior results of being able to expel air during pumping, while also allowing for pushing-in and pulling-out the O-ring stem using finger pressure. Certain embodiments utilize a valve housing, which can be a plastic or similar material and can be molded or otherwise attached to a prosthetic socket. In some embodiments, a valve housing can be threaded for mating with the valve body. In other embodiments, the valve body can either reversibly mate with the threaded valve housing or irreversibly mate with the valve housing. The configuration of the attachment (e.g., threading) is not particularly limited.
In certain embodiments of the present invention, the 360 degree rotatable barb and stem can provide the unexpected results of eliminating torqueing and twisting of the housing and allowing for inspection or actual examination of the distal limb without removal of the prosthetic. Other embodiments of the present invention comprise systems with the various combinations of components described herein for maintaining a suction seal throughout a 360 degree rotation, with no hose binding, for amputees. The systems described herein can comprise and/or function with various pumping systems, such as, for example, any pumping system (e.g., electronic or mechanical) for elevated vacuum suspension-type sockets, including simple hand pumping systems.
In some embodiments and methods, a valve body of the present invention can be retrofitted to an existing valve housing previously attached to a prosthetic limb. In further embodiments, the product and systems comprise a valve body that can be unscrewed or unmated from a valve housing to allow for examination or palpation of a distal limb of an amputee. In some embodiments, the valve body can be screwed into the valve housing, allowing for stem rotation and compressing at least one o-ring that can form a seal. As will be appreciated, certain embodiments allow for convenient placement of the valve housing for a patient and/or individual tasked with aiding or caring for an amputee. Embodiments of the present invention also provide the superior, unexpected results by avoiding and/or preventing distal limb edema by allowing for an improved and superior seal and physical examination and positioning of a distal limb in a socket of a prosthetic limb, which can be used to confirm that total contact is present.
The components and systems described herein can be made of various materials capable of forming similar structures and functions as those described herein and shown in the figures. The figures provide certain aspects of the invention and provide reasonable, though not limiting, methods of constructing and using the described and illustrated embodiments. The devices and/or systems of the present invention are not limited to any particular distal limb amputation or undeveloped limb or limb bud. The devices and or systems of the present invention can be deployed in various positions and/or multiple positions depending on the needs of the individual and/or prosthetic and/or limb amputation and these positions and configurations would be recognizable to one of skill in the art. Moreover, the devices and systems of the present invention are not limited in size or caliber of materials or final products, and the individuals needs will dictate the necessary sizes, calibers, materials, etc.
Barb 103 can be configured to attach to a hose 108 and is configured to create an airtight seal with the hose. As shown in
As shown in
An example of a suitable inner diameter of a valve housing, for transfemoral amputees, is about 26 mm. A valve housing diameter can also be about 20-30 mm, about 25-30, mm, about 20-25 mm, and ranges therebetween. An example of a valve body height is about 19 mm, which can be configured so as not to protrude far beyond an outer socket contour of a prosthetic device. A valve body height may be about 15-20 mm, about 15-25 mm, and ranges therebetween. An example of a diameter of a fingergrip portion is about 21 mm, which can be sized to permit a user easy fingertip access and security for a stem's installation and removal even for users with hand impairment. The fingergrip portion's size is not particularly limited and can have a diameter of about 20-25 mm, about 15-25 mm, about 20-22 mm, and ranges therebetween. An example of a stem can have an about 11 mm long by 12 mm thick cylindrical barrel that may accommodate 1, 2 or 3 O-rings for a positive seal to the valve body. In some embodiments, a stem can have a thickness of about 10-12 mm, about 10-13 mm, about 10-15 mm, about 12-15 mm, and ranges therebetween. A stem can have a length of about 10-15 mm, about 12-15 mm, about 10-13 mm, and ranges therebetween. A stem may also house a bore hole of about at least 1 mm through the cylindrical barrel of a stem to enable air to be evacuated from a prosthetic socket. The stem bore may be about 0.5-1.5 mm, about 0.75-1.25 mm, about 1-1.5 mm, and ranges therebetween. A stem may also comprise a tapered lower section that is about 2.8 mm, configured to facilitate user placement of the stem into the valve body for proper seating. The tapered lower section can be about 2-3 mm, about 2.5-3 mm, about 2.75-3 mm, about 2.75-3.25 mm, about 3-3.25, mm, and ranges therebetween. A stem and valve body can be configures so that an auditory click is heard to provide confirmation for the user that the stem and the valve body are fully engaged and forming an airtight seal. A fingergrip portion of a valve plug assembly can be about 21.5 mm in diameter, which encourages ease of use via simple prehension. The entire prosthetic valve assembly 100 can be made proportionately smaller to fit the needs of children, adolescents and smaller adults, and can be suitably configured for other limbs, and such sizing would be immediately envisaged by the skilled artisan.
In some embodiments, a valve body comprises an o-ring around its outer circumference. In some embodiments a valve body can be configured so as to form an airtight seal when finger pressure is applied to screw the valve body into an inner circumference of a locking ring. Referring to
Providing two o-rings on a stem can provide for an improved seal that allows a valve plug assembly to form an airtight seal to a valve body while also being removable with only finger pressure. Such an arrangement provides for the improved and unexpected results to be able to form and maintain a seal when air is evacuated at negative pressures between about −1 to about −25 inches of mercury (in. Hg.) while also being removable with only finger pressure. Negative pressures can be about −1 to about −10 in. Hg, about −10 to about −20 in. Hg., about −15 to about −25 in. Hg., about −10 to about −25 in. Hg, and ranges therebetween. Lower limb amputees can generally tolerate (and, at times, prefer) a higher negative atmosphere while upper limb amputees prefer (and, at times, require) a lesser negative atmosphere. These differences may be due to the cross-sectional dimensional differences of upper and lower residuums (smaller vs larger surface areas), as well as internal limb hypersensitiveness such as neuromas and adhesions and/or scarred tissues. Users can set the chosen pump device to acquire and maintain very specific negative atmospheric values that are comfortable yet will also properly suspend the prosthesis, and these corresponding pressures would be immediately understood by the skilled artisan given the context and the particular application. A valve assembly as described herein can be configures to convey any of these amount of negative atmosphere that are desired. Such an arrangement can allow for increased ease of use for an amputee to more easily, more efficiently, and more effectively install a prosthetic without the need for intervention from a medical professional, such as a prosthetist, to reestablish a positive seal. Embodiments of the invention described herein provide the improved results of greatly improving the installation of prosthetic limbs that are designed for both normal and even greater amounts of activity, thus allowing amputees to increase their mobility and dexterity for a prosthetic attached to a lost limb.
Valve body 109 can be threaded so that it can be threadedly attached to locking ring 110. A locking ring can be threaded on its inner circumference so that it may securely mate with a valve body. Referring to
In some embodiments, a locking ring may be made of a material such as aluminum and can comprise internal threads along its inner circumference that can comprise polyoxymethylene, polyethylene, polypropylene, polyurethane, polyvinyl chloride, and the like, and mixtures thereof. A valve body can comprise aluminum, titanium, stainless steel, polyoxymethylene, polyethylene, polypropylene, polyurethane, polyvinyl chloride, and the like, and mixtures thereof. Embodiments of a prosthetic valve assembly as described herein provide for disassembly of individual pieces while also allowing for reassembly of the device without any special tools, or the use of hand force or finger pressure only. Such an arrangement provides for a device having improved hygienic properties because it can easily be disassembled, cleaned, and reassembled and surprisingly also produce a proper seal to achieve a vacuum when installing a prosthetic limb.
Some embodiments of the invention described herein comprise a prosthetic socket comprising a locking ring and an air evacuation valve. The locking ring can be configured as described herein to mate and secure with a valve body and valve plug assembly as described herein. Embodiments of a prosthetic socket can comprise a valve housing that can be externally and internally threaded to secure a valve body and a locking ring, and an air evacuation valve. A valve assembly can be attached to a prosthetic device and a pump and can be configured to permit a high and rapid passage of air to achieve a high negative vacuum atmosphere when air is evacuated after attaching a valve plug assembly such as those described herein.
Certain embodiments comprise a method of securing a prosthetic device to an amputated limb comprising attaching a prosthetic limb to the end of an amputated limb, attaching a locking ring to an opening and connecting to a socket in the prosthetic limb; attaching a valve body to the locking ring; attaching a valve plug assembly to the valve body; attaching a hose to the valve plug assembly; attaching a vacuum pump to the hose; applying a vacuum to the hose to apply a vacuum to the prosthetic limb; and creating a vacuum-tight seal of the prosthetic limb to the amputated limb. In some embodiments, the valve plug assembly is attached to valve body without the use of threading. In some embodiments, a valve body is attached to a valve housing without any threading. In some embodiments, a valve plug assembly is attached to a valve body without threading and the valve body is attached to the housing with threading.
In some embodiments, a prosthetic valve may comprise a valve plug assembly, a valve body, a valve housing, and a hose attached to the valve plug assembly; wherein the prosthetic valve is attached to a prosthetic and the prosthetic valve remains attached to the prosthetic while the prosthetic is in use. In some embodiments, after applying a vacuum using a prosthetic valve as disclosed herein, a valve plug assembly may be removed and a plug may be inserted into a valve body opening, thereby retaining a vacuum inside of the prosthetic.
In some embodiments, a method of securing a prosthetic device to an amputated limb can comprise attaching a liner to an amputated limb prior to attaching the prosthetic device. A liner can comprise fabric, silicone gel, urethane or the like and combinations thereof. A liner can be used to in conjunction with a prosthetic, which can improve the vacuum and ease the stresses to the skin in the presence of standard suction suspension or elevated vacuum suspension that can be applied to a prosthetic limb when securing the prosthetic to the limb.
Valve body 109 can be configured so that it is absent any air holes in its flat bottom aspect, which may not make contact with, either, the liner over the residuum or the bare skin if no liner is present. Thus, air may not be exhausted through such holes, which can be common in other valves of the prior art, which can cause skin blisters and/or damage to a polymer liner. Embodiments of the invention described herein can exhaust air around the outer perimeter of a valve body and/or an inner perimeter of an inner surface of a valve housing. This is an additional unique feature of this Valve Assembly. Certain embodiments as described herein can comprise a circular venting system with a clearance of about 1/5000th's of an inch. The sizing of a circular venting system can be configured so that it is too narrow for skin tissue to enter into but large enough to permit the easy flow of air for evacuation.
Embodiments of attaching a prosthetic limb to the distal end of an amputated limb can produce the unexpected and improved results of reducing unwanted movement of the prosthetic relative to the amputated limb, which provides for reduced injuries to a patient. Such injuries can include but are not limited to, edema, skin injury resulting from shear, rotation, or friction, blisters, sores, and the like. Accordingly, embodiments of the devices and methods as described herein provide for a way of reducing or eliminating these injuries to an amputated limb. Embodiments of the devices described herein can create an improved seal between a prosthetic and an amputated limb, thus improving a user's proprioception in a drastic improvement over other prior art prosthetics. Embodiments of the methods and devices described herein can allow for an improved seal between a prosthetic and an amputated limb and can maintain an improved seal as a limb swells and shrinks, diurnally as a result of changes in body temperature, blood flow, salt retention and consumption of certain foods and drinks, etc. By providing for an improved seal that accounts for such swelling and shrinking, the methods and devices described herein can achieve the improved and unexpected results of maintaining an improved seal for 12, 24, 36, 48 hours, or longer.
Certain embodiments comprise a method of making a prosthetic socket comprising placing a valve housing in an opening in a prosthetic socket so that a portion of the valve housing passes through the opening attaching a locking ring to the opening in the prosthetic socket; attaching a valve body to the locking ring; attaching a valve plug assembly to the valve body.
In an alternative embodiment, a prosthetic valve assembly can comprise a pressure-release portion; a valve body portion that is connected to the pressure-release portion wherein the valve body portion comprises a stem and a barb; wherein the stem can be threaded; and the valve body can comprise a valve diaphragm and a valve spring. The prosthetic valve assembly may also comprise a socket nut that can be threaded to mate with a threaded stem and secure the prosthetic valve assembly to a socket of a prosthetic. The valve body may comprise an internal vent spool.
As used herein the terms, “prosthetic”, “prosthetic device”, and “prosthetic limb” can be used interchangeable and are not particularly limiting. The skilled artisan would understand the meaning of these terms to include prosthetic arms and legs and variations of these.
As used herein, the terms “finger pressure” and “hand force” can be used interchangeably and refer to the amount of force needed to manipulate (e.g., remove or insert) portions of the embodiments as described herein and the meaning of which would immediately be understood by the skilled artisan. For example, and without limitation, finger pressure may refer to the amount of force that is applied to remove one part of a prosthetic valve as described herein, where such force can be applied without the aid of tools.
Although the foregoing description is directed to the preferred embodiments of the invention, it is noted that other variations and modifications will be apparent to those skilled in the art, and may be made without departing from the spirit or scope of the invention. Moreover, features described in connection with one embodiment of the invention may be used in conjunction with other embodiments, even if not explicitly stated above.
This application claims priority to of U.S. Provisional Application No. 62/385,710 filed Sep. 9, 2016, the contents of which is incorporated by reference herein in its entirety.
| Number | Date | Country | |
|---|---|---|---|
| 62385710 | Sep 2016 | US |
