WO2019040837A1 - Système sous vide pour pied prothétique - Google Patents

Système sous vide pour pied prothétique Download PDF

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Publication number
WO2019040837A1
WO2019040837A1 PCT/US2018/047893 US2018047893W WO2019040837A1 WO 2019040837 A1 WO2019040837 A1 WO 2019040837A1 US 2018047893 W US2018047893 W US 2018047893W WO 2019040837 A1 WO2019040837 A1 WO 2019040837A1
Authority
WO
WIPO (PCT)
Prior art keywords
chamber
prosthetic foot
resilient
valve
compressible member
Prior art date
Application number
PCT/US2018/047893
Other languages
English (en)
Inventor
Kodi Nixon
James M. Scott
Brian Werner
Gene Parker
Original Assignee
Ability Dynamics, Llc
Priority date (The priority date is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the date listed.)
Filing date
Publication date
Application filed by Ability Dynamics, Llc filed Critical Ability Dynamics, Llc
Publication of WO2019040837A1 publication Critical patent/WO2019040837A1/fr

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Classifications

    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61F—FILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
    • A61F2/00—Filters implantable into blood vessels; Prostheses, i.e. artificial substitutes or replacements for parts of the body; Appliances for connecting them with the body; Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents
    • A61F2/50—Prostheses not implantable in the body
    • A61F2/60—Artificial legs or feet or parts thereof
    • A61F2/66—Feet; Ankle joints
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61F—FILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
    • A61F2/00—Filters implantable into blood vessels; Prostheses, i.e. artificial substitutes or replacements for parts of the body; Appliances for connecting them with the body; Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents
    • A61F2/50—Prostheses not implantable in the body
    • A61F2/68—Operating or control means
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61F—FILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
    • A61F2/00—Filters implantable into blood vessels; Prostheses, i.e. artificial substitutes or replacements for parts of the body; Appliances for connecting them with the body; Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents
    • A61F2/50—Prostheses not implantable in the body
    • A61F2/68—Operating or control means
    • A61F2/74—Operating or control means fluid, i.e. hydraulic or pneumatic
    • A61F2/742—Low pressure systems, e.g. vacuum pump
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61F—FILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
    • A61F2/00—Filters implantable into blood vessels; Prostheses, i.e. artificial substitutes or replacements for parts of the body; Appliances for connecting them with the body; Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents
    • A61F2/50—Prostheses not implantable in the body
    • A61F2/68—Operating or control means
    • A61F2/74—Operating or control means fluid, i.e. hydraulic or pneumatic
    • A61F2/748—Valve systems
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61F—FILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
    • A61F2/00—Filters implantable into blood vessels; Prostheses, i.e. artificial substitutes or replacements for parts of the body; Appliances for connecting them with the body; Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents
    • A61F2/50—Prostheses not implantable in the body
    • A61F2002/5007—Prostheses not implantable in the body having elastic means different from springs, e.g. including an elastomeric insert
    • A61F2002/5009—Prostheses not implantable in the body having elastic means different from springs, e.g. including an elastomeric insert having two or more elastomeric blocks
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61F—FILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
    • A61F2/00—Filters implantable into blood vessels; Prostheses, i.e. artificial substitutes or replacements for parts of the body; Appliances for connecting them with the body; Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents
    • A61F2/50—Prostheses not implantable in the body
    • A61F2002/501—Prostheses not implantable in the body having an inflatable pocket filled with fluid, i.e. liquid or gas
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61F—FILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
    • A61F2/00—Filters implantable into blood vessels; Prostheses, i.e. artificial substitutes or replacements for parts of the body; Appliances for connecting them with the body; Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents
    • A61F2/50—Prostheses not implantable in the body
    • A61F2/60—Artificial legs or feet or parts thereof
    • A61F2/66—Feet; Ankle joints
    • A61F2002/6614—Feet
    • A61F2002/6642—Heels
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61F—FILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
    • A61F2/00—Filters implantable into blood vessels; Prostheses, i.e. artificial substitutes or replacements for parts of the body; Appliances for connecting them with the body; Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents
    • A61F2/50—Prostheses not implantable in the body
    • A61F2/60—Artificial legs or feet or parts thereof
    • A61F2/66—Feet; Ankle joints
    • A61F2002/6614—Feet
    • A61F2002/6657—Feet having a plate-like or strip-like spring element, e.g. an energy-storing cantilever spring keel
    • A61F2002/6664—Dual structures made of two connected cantilevered leaf springs
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61F—FILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
    • A61F2/00—Filters implantable into blood vessels; Prostheses, i.e. artificial substitutes or replacements for parts of the body; Appliances for connecting them with the body; Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents
    • A61F2/50—Prostheses not implantable in the body
    • A61F2/60—Artificial legs or feet or parts thereof
    • A61F2/66—Feet; Ankle joints
    • A61F2002/6614—Feet
    • A61F2002/6657—Feet having a plate-like or strip-like spring element, e.g. an energy-storing cantilever spring keel
    • A61F2002/6671—C-shaped
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61F—FILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
    • A61F2/00—Filters implantable into blood vessels; Prostheses, i.e. artificial substitutes or replacements for parts of the body; Appliances for connecting them with the body; Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents
    • A61F2/50—Prostheses not implantable in the body
    • A61F2/78—Means for protecting prostheses or for attaching them to the body, e.g. bandages, harnesses, straps, or stockings for the limb stump
    • A61F2/80—Sockets, e.g. of suction type
    • A61F2002/802—Suction sockets, i.e. utilizing differential air pressure to retain the prosthesis on the stump

Definitions

  • TITLE VACUUM SYSTEM FOR A PROSTHETIC FOOT
  • Prosthetic feet are well known in the art. In use, such prosthetic feet are typically mounted to either an above knee amputation socket or a below knee amputation socket and are designed to mimic the natural gait of a user. Traditionally, the sockets of most amputation types are retained on the user through friction. This friction has been achieved by using socks or liners of various specialized materials. The major drawback with this system has been that over the course of a day, the amputated limb will change its volume, and the friction force will change accordingly. Replacing the friction retention system with a vacuum retention system has proven to be advantageous to the user for many reasons. The biggest reason being that vacuum helps the limb volume to remain more stable which improves socket retention and limb health.
  • vacuum systems for prosthetic feet may be provided to further enhance the feel, fit, and function of the foot to the user for all types of lower limb amputation (e.g. above knee, below knee, etc.). Problems exist with vacuum systems including the noise of the electric motor and vacuum pump being disturbing to the user and those nearby and high maintenance requirements due to the complexity of the vacuum system.
  • An exemplary vacuum system for a prosthetic foot may comprise a compressible member, a chamber located within the compressible member, and a valve system that connects to the prosthetic socket of the user.
  • the valve system may comprise a valve housing, a pair of valves, an exhaust port, a fitting, an air passageway, and an air return.
  • the prosthetic foot may comprise a resilient bottom member having a first bottom end and a second bottom end, a resilient top member having a first top end and a second top end, wherein the first top end is connected to the first bottom end of the resilient bottom member, and wherein the resilient top member is connected to a mounting bracket and positioned over the resilient bottom member and directed towards the back of the prosthetic foot.
  • Figure 1 is a perspective view representatively illustrating a vacuum system on a prosthetic foot in accordance with exemplary embodiments of the present technology
  • Figure 2 is a rear view representatively illustrating the vacuum system on a prosthetic foot in accordance with exemplary embodiments of the present technology
  • Figure 3 is a side view representatively illustrating the vacuum system on a prosthetic foot in accordance with exemplary embodiments of the present technology
  • Figure 4 is a side, cross section view along the line A-A representatively illustrating the vacuum system on a prosthetic foot in accordance with exemplary embodiments of the present technology
  • Figure 5 is a partial rear, cross section view along the line B-B representatively illustrating the vacuum system on a prosthetic foot in accordance with exemplary embodiments of the present technology
  • Figure 6 is a perspective view of a compressible member with a heel member and a top insert in accordance with exemplar ⁇ ' embodiments of the present technology
  • Figure 7 is a rear view of the compressible member with the heel member and the top insert in accordance with exemplar ⁇ ' embodiments of the present technology
  • Figure 8 is a side view of the compressible member with the heel member and the top insert in accordance with exemplar ⁇ ' embodiments of the present technology
  • Figure 9 is a perspective view of the heel member of the compressible member in accordance with exemplary embodiments of the present technology.
  • Figure 10 is a perspective view of the top insert of the compressible member in accordance with exemplary embodiments of the present technology
  • Figure 11 is a side view of the top insert of the compressible member in accordance with exemplary embodiments of the present technology
  • Figure 12 is a rear view of the top insert of the compressible member in accordance with exemplary embodiments of the present technology
  • Figure 13 is a bottom view of the top insert of the compressible member in accordance with exemplary embodiments of the present technology
  • Figures 14A-D show various view of a valve housing in accordance with exemplary embodiments of the present technology
  • Figure 15 is a perspective view of an additional embodiment of a compressible member with a heel member and a side insert in accordance with exemplary embodiments of the present technology
  • Figure 16 is a side view of the additional embodiment of the compressible member with the heel member with the side insert removed in accordance with exemplary embodiments of the present technology
  • Figure 17 is a bottom view of the additional embodiment of the compressible member with the heel member and the side insert in accordance with exemplary embodiments of the present technology
  • Figure 18 is a rear view of the additional embodiment of the compressible member with the heel member and the side insert in accordance with exemplary embodiments of the present technology
  • Figure 19 is a perspective view of the side insert of the compressible member in accordance with exemplary embodiments of the present technology
  • Figure 20 is a side view of the side insert of the compressible member in accordance with exemplary embodiments of the present technology
  • Figure 21 is a rear view of the side insert of the compressible member in accordance with exemplary embodiments of the present technology
  • Figure 22 is a perspective view of an additional embodiment of a compressible member in accordance with exemplary embodiments of the present technology
  • Figure 23 is a rear view of the additional embodiment of the compressible member in accordance with exemplary embodiments of the present technology.
  • Figure 24 is a side view of the additional embodiment of the compressible member in accordance with exemplary embodiments of the present technology.
  • the present technology may be described in terms of functional block components and various processing steps. Such functional blocks may be realized by any number of components configured to perform the specified functions and achieve the various results.
  • the present technology may be used with a prosthetic foot for various amputation types (above knee, below knee, etc.)
  • the present technology may be practiced in conjunction with any number of materials and methods of manufacture and the system described is merely one exemplary application for the technology.
  • a vacuum system for a prosthetic foot is illustrated, which allows for a more comfortable fit of the residual limb to the prosthetic socket of a user. Additionally, studies have shown that elevated vacuum above a certain level is beneficial for residual limb health and maintaining residual limb volume.
  • a typical prosthetic foot stores energy during the gait cycle and transfers the return potential energy in order to "put a spring in your step.”
  • the roll through of a prosthetic foot is defined in the gait cycle as the process from the heel-strike phase to the mid-stance phase to the toe-off phase.
  • the heel-strike phase begins when the heel, or rear portion of the foot touches the ground, and includes the loading response on the foot.
  • the mid- stance phase is when the foot is flat on the ground and the body's center of gravity is over the foot.
  • the toe-off phase is the finish of the stance phase and ends when the tip of the foot is the only portion in contact with the ground, and the load is entirely on the toe/tip of the foot. This is just prior to the swing phase, which constitutes the other half of the gait cycle.
  • the tibia portion of the leg or that section of the leg defined below the knee, rotates through in relation to the ground.
  • the mid-stance phase is defined as the lower leg at 90 degrees to the ground, then looking at the side view of an individual, the angle of the lower leg at the heel-strike phase may occur at approximately 65 degrees and the angle of the lower leg at the toe-off phase may occur at approximately 110 degrees.
  • the rotation of the lower leg on the theoretical ankle is notated as tibial progression or lower leg progression during the stance phase.
  • a vacuum system 100 for a prosthetic foot 102 is shown.
  • the prosthetic foot 102 may comprise a resilient bottom member 104, a resilient top member 106, a connection point 108 attached to the top member 106 and configured for attachment to a user, and a compressible member 1 10.
  • the resilient bottom member 104 may have a front end 112 and a rear end 114.
  • the resilient top member 106 may have a front end 116 and a rear top end 118. Further, the front end 112 of the resilient top member 106 can be connected to the front end 116 of the resilient bottom member 104, while the resilient top member 106 can be positioned over the resilient bottom member 104 and directed towards the rear of the prosthetic foot 102.
  • connection point 108 may be coupled to the rear top end 118 of the resilient top member and comprise a mounting portion 120.
  • the mounting portion 120 may comprise a spherical dome and an attachment portion, which is a standard male pyramid adapter used in the prosthetic industry.
  • the pyramid adapter may be coupled with a standard receiver used in the practice of prosthetics, for example, a Pope style attachment, which is commonly known in the prosthetic industry.
  • the mounting portion 120 may use a standard receiver adapter, as understood by one of ordinary skill in the art. According to various embodiments the mounting portion 120 may facilitate attachment to the residual limb of the user.
  • the mounting portion 120 may comprise a centerline that is aligned with the weight line of the user.
  • the top member 106, bottom member 104, and compressible member 110 transfer energy between themselves in a natural, true foot manner.
  • the loading response during the heel strike phase compresses compressible member 1 10 and top member 106, which in turn passes energy into, and causes a deflection of, a rear portion of bottom member 104.
  • Energy is transferred towards the front of prosthetic foot 100 during the mid-stance phase.
  • an upward deflection of at least one of bottom member 104 and top member 106 stores energy during the transition from the mid-stance phase to the toe-off phase of the gait cycle.
  • the prosthetic foot 102 is configured to increase the surface-to-foot contact through the gait cycle.
  • the increased surface contact allows for a smoother gait cycle, and increases stability in comparison to the typical prior art prosthetics.
  • the underside of bottom member 104 has different contours that provide increased surface contact for different types of uses.
  • the resilient bottom member 104 of the prosthetic foot 102 can have various shapes depending on desired use.
  • the desired use may include prosthetic feet for above-knee amputees or prosthetic feet for below-knee amputees.
  • the prosthetic foot 102 for above-knee amputees may comprise a bottom member 104 having a curved bottom with no inflection point.
  • the prosthetic foot 102 comprises a resilient bottom member 104 having a partially curved portion from the front end 112 to the rear end 114 of the resilient bottom member 104.
  • the bottom member 104 may comprise a constant arc due to single radius forming the partial curve of the bottom member 104.
  • the curve of the bottom member 104 can be designed as a spline of variable radii.
  • the curve of bottom member 104 in above-knee prosthetic foot facilitates keeping an artificial knee stable because the forces substantially restrict the knee from bending.
  • the curved bottom member 104 enables a rocking motion even if the artificial knee is hyper-extended.
  • the prosthetic foot 102 for below-knee amputees may comprises a bottom member 104 having a partially curved front portion and a substantially linear rear portion.
  • the prosthetic foot 102 comprises a resilient bottom member 104 having a partially curved portion from the front end 112 to a middle portion 122 and a substantially linear portion from the middle portion 122 to the rear end 114 of the resilient bottom member 104.
  • the front portion from the front end 112 to the middle portion 122 of resilient bottom member 104 may have a constant arc due to single radius forming the partial curve.
  • the front portion from the front end 112 to the middle portion 122 of resilient bottom member 104 can have a curve designed as a spline of variable radii.
  • the rear portion from the middle portion 122 to the rear end 114 of the resilient bottom member 104 can be substantially straight and tangent to the front portion such that bottom member 104 does not have an inflection point.
  • a straight rear portion and a curved front portion of bottom member 104 facilitates rotation of the tibia progressing the natural rotation of the knee forward and preventing hyper-extension of the knee.
  • resilient bottom and top members 104 are provided in accordance with an exemplary embodiment.
  • the 106 may be made of glass fiber composite.
  • the glass fiber composite may be a glass reinforced unidirectional fiber composite.
  • the fiber composite material is made of multiple layers of unidirectional fibers and resin to produce a strong and flexible material.
  • the fibers may be glass fibers or carbon fibers. Specifically, layers of fiber are impregnated with the resin, and a glass reinforcement layer can be positioned between at least two fiber weave layers. Typically, several layers of the unidirectional fibers or tape are layered together to achieve the desired strength and flexibility. Further, in various embodiments the layers of unidirectional fibers or tape can be oriented at various angles.
  • the vacuum system 100 may be used with any conventional prosthetic leg (consisting of socket, pylon, etc.).
  • the vacuum system 100 may be configured to connect to any commercially available prosthetic socket designed to work with a vacuum attachment apparatus. Specifically, the vacuum system 100 will connect to an elevated vacuum suspension setup and also should also work with any commercially available prosthetic socket designed for passive suction suspension.
  • the vacuum system 100 may be utilized with the existing compressible member 110.
  • the vacuum system may be added to a foot without a compressible member or used in conjunction with an existing compressible member in a prosthetic foot.
  • the vacuum system 100 for a prosthetic foot may comprise a compressible member 110, a chamber 124 located within the compressible member 110, and a valve system 126 that connects to the prosthetic socket of the user (not shown).
  • the compressible member 110 may comprise a heel member 128 and a top plug insert
  • the top plug insert 130 and the heel member 128 can be any suitable shape as contemplated by one of ordinary skill in the art.
  • the top plug insert 130 may be inserted within the heel member 128 to form the chamber.
  • the heel member 128 may comprise a pair of sidewalls 132, 134 with internal bores 136, 138, a front wall 133, a rear wall 135, and a cavity 140 that receives the top plug insert 130.
  • the cavity 140 may comprise an internal surface 142 or any other suitable shape.
  • the top plug insert 130 may comprise an internal bore 144 and a void 146 that function as an air passageway 148.
  • the top plug insert 130 may comprise a concave lower surface 150.
  • the internal bores 136, 138 of heel member 128 align with the internal bore 144 of the top plug insert 130 to receive the valve system 126, shown in Figure 5.
  • the concave internal surface 142 of the cavity 140 and the concave lower surface 150 of the top plug insert 130 form the chamber 124.
  • the chamber 124 may be generally in the shape of an oblate spheroid, a short or flattened octahedron, a rectangular pillow shape, or any other shape that can be collapsed on itself when a vertical force is applied.
  • the top plug insert 130 is both bonded in place and mechanically locked by the valve system 126 which protrudes through the internal bores 136, 138 of heel member 128 and the internal bore 144 of the top plug insert 130.
  • the top plug insert 130 may be bonded to the heel member 128 using an adhesive appropriate for bonding two elastomeric deformable materials, such as rubber, together.
  • the top plug insert 130 and the cavity 140 within the heel member 128 can be any suitable shape as contemplated by one of ordinary skill in the art as long as the top plug insert 130 is capable of being inserted within the cavity 140 within the heel member 128 to create the chamber 124.
  • the chamber 124 may be located within the compressible member 110 and is connected to the valve system 126 by the air passageway 148. In one embodiment, the chamber 124 may be formed between the internal surface 142 of the heel member 128 and the lower surface 150 of the top plug insert 130. In one embodiment, chamber 124 may comprise a generally rectangular in shape as shown in Figure 6. When viewed from the rear, as shown in Figures 5 and 7, the chamber 124 is roughly elliptical in shape, which allows the chamber to fully collapse when loaded. In another embodiment, the chamber 124 is generally rectangular when viewed from the side and from the back. In another embodiment chamber 124 may comprise an upside- down T shape when viewed from the side. In one embodiment the volume of chamber 124 is approximately .1 to .25 cubic inches. It should be understood that any volume contemplated may be used as long as the volume is configured to provide enough back pressure to seal the socket to the residual limb.
  • the chamber 124 may be connected to the valve system 126 by way of air passageway
  • the air passageway 148 can be a void in the top plug insert 130 or a separate tube located inside the top plug insert 130.
  • the separate tube comprising air passageway 148 may be a small diameter stainless steel tubing, or small diameter carbon fiber tubing, small diameter flexible plastic tubing, and the like.
  • air passageway 148 may connect chamber 124 to the valve system 126 in a way external to compressible member 110.
  • the air passageway 148 may be bi-directional.
  • the chamber 124 contemplated above may exist solely between the internal surface 142 of the heel member 128 and the lower surface 150 of the top plug insert 130 and may be any suitable shape that can compress and/or collapse on itself. Specifically, in one embodiment, there is not any contemplated internal membrane located within the chamber 124 between the internal surface 142 of the heel member 128 and the lower surface 150 of the top plug insert 130.
  • the valve system 126 may comprise a valve housing 152 and an air return 154.
  • the valve housing 152 may comprise a pair of valves 156, 158, an exhaust port 160, and a fitting 162.
  • An air chamber 164 connects the pair of valves 156, 158 and allows for air to travel therebetween.
  • a valve housing passageway 165 connects the passageway 148 to the air chamber 164. Air may travel into the housing through valve 156 and out through valve 158.
  • the air return 154 connects to the prosthetic socket of the user, which contains the vacuum attachment apparatus.
  • the air return 154 may comprise standard 1/8 inch diameter tubing used to connect vacuum systems to prosthetic sockets.
  • valve housing 152 may be located within the internal bores
  • the internal bore 144 of the top plug insert 130 is located within the compressible member 110 and between the sidewalls 132, 134, the front wall 133, and the rear wall 135 of the heel member 128 of the compressible member 110. In one embodiment, the internal bore 144 of the top plug insert 130 is located within the compressible member 110 and between the sidewalls 132, 134, the front wall 133, and the rear wall 135 of the heel member 128 of the compressible member 110 and oriented substantially horizontally therewithin. While the shape of the valve housing 152 of the valve system 126 is shown as generally cylindrical, any configuration and shape may be contemplated.
  • the valve housing 152 may comprise the fitting 162 located at a first end and the exhaust port 160 located at a second end opposite the first end.
  • the internal bores 136, 138 of the heel member 128 and the internal bore 144 of the top plug insert 130 and the valve housing 152 are typically designed with generally the same shape and dimensions such that a tight fit of the valve housing 152 within the internal bore(s) exists.
  • the fitting 162 may be coupled to the air return 154 at the first end, which in turn may be connected to the user's prosthetic socket that contains the vacuum attachment apparatus (not shown).
  • the first valve 156 may be coupled to the second end of the fitting 162 by any suitable manner.
  • the fitting 162 has a 1/8 inch internal diameter tube fitting at the first end, and 10-32 UNF threaded connection with an O-ring gasket that seals a mating face 166 of the fitting 162 to an internal wall 168 of the valve housing 152 when fully tightened down and installed within the inner bore 130.
  • An example of the fitting 162 is produced by Pneumadyne® and is part number EB-30-250.
  • the exhaust port 160 may be coupled to the second end of the valve housing 152.
  • the exhaust port 160 may be coupled to the valve housing 152 in any suitable manner.
  • the exhaust port 160 may comprise a filtered exhaust port through which the air exiting travels to the atmosphere at a first end of the exhaust port.
  • Some examples of the exhaust port are McMaster-Carr® part number 9833K18 or alternatively Industrial Specialties Mfg. part number BV-1032M-40-B.
  • the McMaster- Carr® part is sealed using Teflon® tape on the threads of the fitting.
  • the Industrial Specialties Mfg. part has an O-ring gasket that seals the mating face to the housing when fully tightened within the valve housing 152.
  • the second valve 158 may be located adjacent an internal end of the exhaust port 160.
  • the first and second valves 156, 158 may comprise one-way duckbill valves.
  • the one-way duckbill valve design has a very low cracking pressure (to allow air in the designed direction of travel) and does not allow air to travel in the reverse direction.
  • the one-way duckbill valve is produced by Minivalve International, part number DU027.002-154.
  • the second valve 158 allows air to exit the valve housing 152 into the atmosphere, while the first valve 156 permits air to enter valve housing 152, as will be discussed in detail below.
  • the area between the first valve 156 and second valve 158 may comprise an open-air chamber 164 that allows air to flow between the two valves.
  • This open air chamber 164 is connected to air passageway 148 by the valve housing passageway 165 and provides free air flow to the chamber 124 within the compressible member 110.
  • the elastic properties and geometry of compressible member 110 allow chamber 124 to expand back to the initial volume when the downward force is eliminated or reduced to the point that the compressible member 110 is no long in contact with the resilient bottom member 104.
  • the second valve 158 then closes and prevents a backflow of air into the valve housing 152 through the exhaust port 160. This causes a negative pressure in valve housing 152.
  • the negative pressure draws air into the valve housing 152 through first valve 156 by way of the fitting 162 and the air return 154.
  • the air return 154 is connected to a prosthetic socket that is designed for an elevated vacuum suspension and the like.
  • the elevated vacuum suspension socket is a commercially available prosthetic socket that uses an elevated vacuum level inside the socket to secure the socket to the amputee's residual limb.
  • the compressible member 110 comprises an elastomeric bumper member having a tapered surface configured to contact the resilient bottom member 104 and attached to an underside of a rear top end of the upper member 106.
  • the compressible member 110 can be vertically oriented with respect to the prosthetic foot 102.
  • the compressible member 110 can act as a heel shock for absorbing force on the downward strike during the user's stride and returns energy during the rest of the gait cycle.
  • the compressible member 110 can be made from an elastomeric material.
  • the elastomeric material may be constructed of natural, synthetic or a hybrid mixture of both natural and synthetic rubber.
  • the elastomeric material has about 80% or greater energy return.
  • the elastomeric material has about 90% or greater energy return.
  • the compressible member 110 can be designed to behave similar to a non-linear spring, thereby allowing larger deflection of the posterior toe during the heel strike.
  • the progressive "spring rate" may lead to a soft initial heel strike but quickly and gently arrests deflection as the compressible member 110 compresses.
  • One benefit of the compressible member 110 is being relatively lightweight in comparison to a prosthetic foot with coiled springs.
  • the compressible member 110 can be located posterior to a vertical axis of the connection point of the mounting portion 120. This enhances the aforementioned and desirable trait of tibial progression.
  • the compressible member 110 can be attached to the underside of the resilient top member 106 in various manners.
  • the compressible member 110 can be fixedly attached using adhesive or fasteners, such as screws.
  • the compressible member 110 may be detachable using fasteners for replacement purposes.
  • the compressible member 110 can be attached to various locations on the underside of the resilient top member 106 or topside of the resilient bottom member 104.
  • the prosthetic foot 100 in a static mode has a gap between the compressible member 110 and the resilient bottom member 104.
  • a gap of about 1/10 inch may be present between the compressible member 110 and the resilient bottom member 104.
  • the compressible member 110 can be in contact with both the resilient top member 106 and the resilient bottom member 104 when the prosthetic foot 100 is in a static position. The lack of a gap results in the compressible member 110 being continuously compressed during the gait cycle, though the compressible member 110 is a compression member and not a tension member since the compressible member 110 is only attached to either the top member 106 or the resilient bottom member 104.
  • the compressible member it is important to the design of the compressible member such that it is only attached to one or the other of the resilient top member 106 and the resilient bottom member 104 and not to both. Connecting the compressible member 110 to both the resilient top and bottom members 106, 104 creates almost a triangle structure, which is very stiff.
  • the compressible member 110 can be in many shapes.
  • the detached portion of the compressible member 110 may have a conical, rectangular, or pyramid shape.
  • the tapered surface of the compressible member 110 can terminate in an apex or hemispherical shape, and the apex can be configured to contact the resilient bottom member 104 in response to deflection of the prosthetic foot 100.
  • the compressible member 110 can terminate in multiple points.
  • the tapered compressible member 110 facilitates a damping of vibration and sound generated during heel strike or release.
  • the extruding portion of the compressible member 110 may be any shape that is non-flat surface. Further, a non-flat surface enhances lateral flexibility if the heel strike is not vertical.
  • the prosthetic foot 100 can be adjusted to accommodate a user in part by adjusting characteristics of the compressible member 110.
  • the durometer of the compressible member 110 can be increased for users with more heel strike force, which may be caused by additional weight or dynamic activity. A heavier user may be better-suited using a compressible member 110 with a large cross-sectional area compared to a lighter user using a compressible member 110 with a small cross- sectional area.
  • the adjustable durometer of the elastomeric material used for the compressible member 110 allows the adjustment of spring rate of the elastomeric heel based on user needs such as activity level, compliance level, weight changes, and the like. Increased durometer can also adjust the ability of chamber 124 to return to the initial volume after being compressed.
  • an additional embodiment of a compressible member 172 may comprise a heel member 174 and a side plug insert 176.
  • the valve system 126 described above may be implemented with the compressible member 172.
  • the heel member 174 comprises a sidewall 178 with internal bore 180, a cavity 182 that receives the side plug insert 176 and a pair of internal voids 184, 186.
  • the side plug insert 176 may comprise an internal bore 188 and a pair of voids 190, 192.
  • the internal bore 180 of heel member 174 aligns with the internal bore 188 of the side plug insert 176 to receive the valve system 126 (not shown). Additionally, the pair of internal voids 190, 192 of the side plug insert and the pair of internal voids 184, 186 of the heel member 174 combine to form an air passageway 194 and a chamber 196.
  • the side plug insert 176 is both bonded in place as discussed above, and mechanically locked by the valve system 126 which protrudes through the internal bore 180 of heel member 174 and the internal bore 188 of the side plug insert 176. It should be understood that orientation of the side plug insert and heel member may be reversed, for example, the side plug insert can be placed in a cavity on either side of the heel member.
  • the vacuum system 100 for a prosthetic foot may comprise a compressible member 198, a chamber 200 located within the compressible member 198, and the valve system 126 that connects to the prosthetic socket of the user (not shown).
  • the chamber 200 may be located within the compressible member 198 and is connected to the valve system 126 by an air passageway 202.
  • the valve system 126 described above may be implemented with a bore 204 located within the compressible member 198.
  • the chamber 200 may be formed by molding in a void in each left and right halves of compressible member 198 and consequently bonding the left and right halves of compressible member 198 into a single piece.
  • the chamber 200 may be formed by molding in a void and sealing the void at one end with a separate piece made of the same material as the compressible member 198 and bonding it into place.
  • chamber 200 may be formed by 3D printing the material or by a material removal process, such as, cutting or machining and drilling the material.
  • chamber 200 may comprise a generally rectangular in shape when viewed from the top. When viewed from the rear and side, as shown in Figures 23 and 24, the chamber 200 is roughly elliptical in shape, which allows the chamber 200 to fully collapse when loaded.
  • chamber 200 is generally rectangular when viewed from the side and from the back.
  • the chamber 200 may comprise an upside-down T shape when viewed from the side or rear.
  • the volume of chamber 200 is approximately .1 to .25 cubic inches. It should be understood that any volume contemplated may be used as long as the volume is configured to provide enough back pressure to seal the socket to the residual limb.
  • the chamber 200 may be connected to valve housing 152 by way of the air passageway
  • the air passageway 202 can be a void in the heel mold or a separate tube located inside compressible member 198 or located between the left and right halves of the compressible member 198.
  • the separate tube comprising air passageway 202 may be small diameter stainless steel tubing, or small diameter carbon fiber tubing, small diameter flexible plastic tubing, and the like.
  • air passageway 202 may connect chamber 200 to valve housing 152 in a way external to compressible member 198.
  • the compressible members 172, 198 are shaped, located, oriented, constructed, and attached to the prosthetic foot similarly to the compressible member 110 discussed above. It should be understood that the compressible members 172, 198 also function similarly to the compressible member 110 discussed above.
  • any apparatus embodiment may be assembled or otherwise operationally configured in a variety of permutations to produce substantially the same result as the present technology and are accordingly not limited to the specific configuration recited in the specific examples.
  • Benefits, other advantages and solutions to problems have been described above with regard to particular embodiments; however, any benefit, advantage, solution to problems or any element that may cause any particular benefit, advantage or solution to occur or to become more pronounced are not to be construed as critical, required or essential features or components.
  • the terms "comprises”, “comprising”, or any variation thereof, are intended to reference a non-exclusive inclusion, such that a process, method, article, composition or apparatus that comprises a list of elements does not include only those elements recited, but may also include other elements not expressly listed or inherent to such process, method, article, composition or apparatus.
  • Other combinations and/or modifications of the above-described structures, arrangements, applications, proportions, elements, materials or components used in the practice of the present technology, in addition to those not specifically recited, may be varied or otherwise particularly adapted to specific environments, manufacturing specifications, design parameters or other operating requirements without departing from the general principles of the same.

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  • Health & Medical Sciences (AREA)
  • Transplantation (AREA)
  • Heart & Thoracic Surgery (AREA)
  • Oral & Maxillofacial Surgery (AREA)
  • Engineering & Computer Science (AREA)
  • Biomedical Technology (AREA)
  • Cardiology (AREA)
  • Vascular Medicine (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Animal Behavior & Ethology (AREA)
  • General Health & Medical Sciences (AREA)
  • Public Health (AREA)
  • Veterinary Medicine (AREA)
  • Orthopedic Medicine & Surgery (AREA)
  • Prostheses (AREA)

Abstract

La présente invention concerne un pied prothétique comprenant un système sous vide configuré pour se fixer à un appareil de fixation sous vide et à un membre résiduel. Le pied prothétique peut comprendre un élément inférieur élastique, un élément supérieur élastique et un système sous vide. L'élément supérieur élastique peut comprendre une extrémité avant et une extrémité arrière. L'élément supérieur élastique peut comprendre une extrémité avant et une extrémité arrière et l'extrémité avant de l'élément supérieur élastique peut être reliée à l'extrémité avant de l'élément inférieur élastique. Le système sous vide peut être couplé à une face inférieure de l'extrémité arrière de l'élément supérieur. Le système sous vide peut comprendre un élément compressible, une chambre située à l'intérieur de l'élément compressible, un système de valve reçu à l'intérieur de l'élément compressible, un passage reliant le système de valve et la chambre, et un retour d'air couplé au système de valve et à l'appareil de fixation sous vide.
PCT/US2018/047893 2017-08-25 2018-08-24 Système sous vide pour pied prothétique WO2019040837A1 (fr)

Applications Claiming Priority (4)

Application Number Priority Date Filing Date Title
US201762550107P 2017-08-25 2017-08-25
US62/550,107 2017-08-25
US201762589025P 2017-11-21 2017-11-21
US62/589,025 2017-11-21

Publications (1)

Publication Number Publication Date
WO2019040837A1 true WO2019040837A1 (fr) 2019-02-28

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Citations (5)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US3331546A (en) * 1965-06-01 1967-07-18 Olin Mathieson Piston return and buffer system
US6645253B2 (en) * 1999-06-03 2003-11-11 Carl A. Caspers Vacuum pump and shock absorber for artificial limb
US20100319530A1 (en) * 2007-06-28 2010-12-23 Byung Sue Ryu Sealing apparatus for square piston used for compressing and feeding fluid
US20140046456A1 (en) * 2012-08-07 2014-02-13 Ability Dynamics, L.L.C. Compression Heel Prosthetic Foot
US9072617B2 (en) * 2012-04-30 2015-07-07 Ossur Hf Prosthetic device, system and method for increasing vacuum attachment

Patent Citations (5)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US3331546A (en) * 1965-06-01 1967-07-18 Olin Mathieson Piston return and buffer system
US6645253B2 (en) * 1999-06-03 2003-11-11 Carl A. Caspers Vacuum pump and shock absorber for artificial limb
US20100319530A1 (en) * 2007-06-28 2010-12-23 Byung Sue Ryu Sealing apparatus for square piston used for compressing and feeding fluid
US9072617B2 (en) * 2012-04-30 2015-07-07 Ossur Hf Prosthetic device, system and method for increasing vacuum attachment
US20140046456A1 (en) * 2012-08-07 2014-02-13 Ability Dynamics, L.L.C. Compression Heel Prosthetic Foot

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