WO2016020819A1 - Prothèse d'extrémité inférieure avec coque implantée - Google Patents

Prothèse d'extrémité inférieure avec coque implantée Download PDF

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Publication number
WO2016020819A1
WO2016020819A1 PCT/IB2015/055864 IB2015055864W WO2016020819A1 WO 2016020819 A1 WO2016020819 A1 WO 2016020819A1 IB 2015055864 W IB2015055864 W IB 2015055864W WO 2016020819 A1 WO2016020819 A1 WO 2016020819A1
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WO
WIPO (PCT)
Prior art keywords
residual limb
socket
bladder
shell
amputee
Prior art date
Application number
PCT/IB2015/055864
Other languages
English (en)
Inventor
Yigal LIVNE
Original Assignee
Livne Yigal
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 Livne Yigal filed Critical Livne Yigal
Publication of WO2016020819A1 publication Critical patent/WO2016020819A1/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
    • A61F2/02—Prostheses implantable into the body
    • A61F2/28—Bones
    • A61F2/2814—Bone stump caps
    • 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

Definitions

  • the invention relates to a partially implantable lower limb prosthesis.
  • Lower-extremity prosthesis is an artificial replacement for any or all parts of a lower limb (leg).
  • Amputation is performed most often due to complications of peripheral vascular disease or neuropathy; trauma, tumor or congenital limb deficiencies are less common causes for amputation.
  • a lower-limb prosthetic device is used to provide an individual whose leg was amputated with the opportunity to perform all functional tasks, particularly ambulation (walking), with minimal difference in performance compared to a body original assembly. In 2000, more than 1.5 million people in the United States lived with amputations.
  • a prosthetic foot-ankle assembly provides a replacement base of support as an alternative to the body assembly during amputees' standing and walking, in addition to providing shock absorption and push-off during walking on even and uneven terrain.
  • One of the most widely prescribed prosthetic devices is the solid-ankle-cushion-heel (SACH) foot, due to its simplicity, low cost, and durability. It may be inappropriate, however, for active community ambulators and sports participants.
  • Articulated assemblies allow motion at the level of the human ankle.
  • the elastic keel foot is designed to mimic the human foot without the use of mechanical joints; the dynamic- response foot is designed to meet the demands of running and jumping for athletic users.
  • Such assemblies typically offer more mobility at the cost of less stability and increased weight.
  • a shank in the prosthesis corresponds to the anatomical lower leg, and is used to connect the socket to the ankle-foot assembly.
  • a central pylon rests inside a cosmetic foam cover and allows for adjustment and realignment of prosthetic components.
  • the strength of the shank is provided by a hard outer shell that is either hollow or filled with lightweight material. Exoskeletal systems are more durable than endoskeletal systems; however, they may be heavier and have a fixed alignment, making adjustments difficult.
  • a socket in the prosthesis contacts the residual limb.
  • a hard socket offers direct contact between the limb and the socket, resulting in decreased friction, no liner bulk, easy cleaning, and increased durability.
  • a soft socket includes a liner as a cushion between the socket and residual limb. This provides additional protection for the limb but may increase friction and bulk.
  • Transtibial socket types include: patellar tendon-bearing (PTB), silicone suction, energy-storing, or bent-knee designs.
  • Transfemoral socket types include: quadrilateral, ischial containment, and contoured adducted trochanteric-controlled alignment method (CAT- CAM) designs.
  • a prosthetic sock is usually worn to help cushion the limb from forces and accommodate for limb volume changes. Prosthetic socks are available in a variety of materials and thickness, and may be worn in layers to achieve the most comfortable fit.
  • a subcutaneous, intramuscular support (1) is provided for a rigid transcutaneous implant, which can be anchored intracorporeally in a bone stump.
  • the support has an intermediate piece between the part of the implant to be intracorporeally anchored and an extracorporeal coupling device that can be coupled to it.
  • a rigid bushing is firmly connected with the intermediate piece, such that an annulus is formed between the wall of the bushing and the intermediate piece, the annulus being closed in the intracorporeal direction, and into which annulus the extracorporeal coupling device can be inserted.
  • a tube made of a flexible material is applied to the outer wall of the bushing, and metallic wool is applied to the flexible tube.
  • US Patent 7655049 discloses a prosthetic device having a socket with an insert having a bladder system for monitoring and compensating for volume fluctuations in a residual limb.
  • the bladders may be organized into zones, with the zones being inflatable to differing pressures depending on volume fluctuations in a residual limb.
  • Pressure sensors may be provided for each bladder or for each zone, and flow regulators may be provided to control fluid flow into or out of the bladders or zones of bladders based on readings from the pressure sensors to control volume within the insert.
  • bladders can be manually inflated depending on an amputee's needs.
  • Fitting of prosthesis is labor-intensive process that consists of a number of trying-on/finishing sessions.
  • an artificial ankle to the residual limb, with cushioning properties and provide a prosthesis comprising a socket adapted for receiving the ankle connected to the residual limb and securing the prosthesis on the residual limb in a way that will (a) provide optimal weight distribution on the residual limb; and (b) will not require additional fitting of prosthesis when the residual limb undergoes changes; and (c) will be comfortable to attach and to wear.
  • the prosthesis should be cheap and require minimal service throughout its lifetime until it is easily replaced when the need arises.
  • the foresaid implantable assembly comprises an implantable part further comprising (a) an anchor being anchorable within an amputee's residual limb bone; and (b) a shell mechanically connectable to the anchor.
  • the shell is conformably configured to the socket such that a substantially full contact therebetween is provided.
  • the aforesaid apparatus comprises (a) an implantable part further comprising (i) an anchor being anchorable within an amputee's residual limb bone; and (ii) a shell mechanically connectable to the anchor; and (iii) a bladder connectable to the shell (b) an external part further comprising (i) a socket receiving the residual limb thereinto; and (ii) a clamping mechanism securing the residual limb in the socket; and (iii) an elongated supporting member.
  • the aforesaid prosthetic apparatus enables the following benefits: (a) it provides optimal weight distribution on the residual limb; and (b) it does not require additional fitting of prosthesis when the residual limb undergoes natural changes; and (c) it is fast and comfortable to attach to the residual limb; and (d) when worn, it provides minimal friction, lateral pressure and lateral torques, as well as comfortable and ventilated prosthesis contact area of the low er limb.
  • the shell and socket are conformably configured to each other such that a substantially full contact therebetween is provided.
  • a further object of the invention is to disclose a lower limb prosthesis comprising (i) a socket that receives a residual limb thereinto; (ii) a clamping mechanism securing said residual limb in said socket; and (iii) an elongated supporting member.
  • a further object of the invention is to disclose a shell designed for implanting into a residual limb.
  • the shell is mechanically connectable to a bone anchor and provides an interface between the lower limb bone and the enclosing skin, such that the amputee's weight is at least partially transferred to the lower limb bone through that interfacing shell.
  • the shell is conformably configured to the socket such that a substantially full contact therebetween is provided.
  • the socket is tightly connected to a sleeve that is fitted to the lower limb, such that the amputee's weight is partially born by the socket and partially transferred by the sleeve to the periphery of residual limb.
  • a further object of the invention is to disclose a socket designed for receiving a residual limb thereinto.
  • a further object of the invention is to disclose a socket that is tightly connected to a prosthesis sleeve that is fitted to the lower limb, where the socket is designed for receiving a residual limb and bear at least partially the amputee's weight and the sleeve is designed to partially bear the amputee's weight and substantially all the torques that are caused during amputee's ambulation.
  • a further object of the invention is to disclose each pair of the shell and socket characterized by a form-factor depending on at least one physical characteristic of the amputee.
  • a further object of the invention is to disclose the form factor possessing a number of preset standard values.
  • a further object of the invention is to disclose shapes and dimensions of the shell and socket which are configured for optimal distribution of pressure caused by the amputee's weight and gait and with a preferred directional attachment.
  • a further object of the invention is to disclose shapes and dimensions of the shell and socket which are configured for optimal distribution of torques caused by the amputee's weight and gait.
  • a further object of the invention is to disclose the characteristic selected form the group consisting of a weight of the amputee, a diameter of the internal bone, a diameter of the residual limb, a volume of muscle tissue of the residual limb, an expected pressure appli ed to the shell according to an amputee's lifestyle and any combination thereof.
  • a further object of the invention is to disclose the prosthetic apparatus comprising a bladder fillable with hydrostatic fluid to fill the volume between the residual limb and the skin that touches the socket, thus providing a cushion and distributing the pressure of the at least partial body weight over essentially the full area of the overlap between the socket and shell.
  • a further object of the invention is to disclose the prosthetic apparatus comprising a bladder fil lable with a variable amount of the hydrostatic fluid to fill the volum e between the residual limb and socket fully, thus distributing the body weight pressure over the full area of the overlap between the socket and shell.
  • the bladder volume can be changed to compensate for variations of any dimensions of the residual limb to maintain a complete contact between the residual limb and socket.
  • a further object of the invention is to disclose the bladder subcutaneously attached to the shell.
  • a further object of the invention is to disclose the bladder made of biocompatible self-sealing material.
  • a further object of the invention is to disclose the bladder adaptable to variation of accommodated fluid by means of insertion and drainage thereof through a syringe needle.
  • a further object of the invention is to disclose the prosthetic apparatus comprising a container additionally accommodating hydrostatic fluid.
  • the container is interconnected with the bladder by means of a pipe; the pipe is provided with a valve configured to allow and block the flow between the container and the bladder.
  • a further object of the invention is to disclose the container substantially flexible to enable the release of the fluid to the bladder and receive the fluid from the bladder.
  • a further object of the invention is to disclose a method for securing prosthesis onto the residual limb so that prosthesis weight is born by the implanted shell.
  • prosthesis is suspended by a supracondylar cuff.
  • prosthesis is clamped over the upper edge of the implanted shell that is designed and cushioned specifically.
  • a further object of the invention is to disclose the prosthetic apparatus provided with a ring-like cushion disposed at a rim of the bladder.
  • a further object of the invention is to disclose the ring-like cushion filled with a fluid.
  • a further object of the invention is to disclose the ring-like cushion and the bladder being integrally inflatable.
  • a further object of the invention is to disclose the clamping mechanism configured for securing prosthesis onto the ring-like cushion.
  • a further object of the invention is to disclose the clamping mechanism configured as unconnected and not close parts of a ring.
  • a further object of the invention is to disclose a bladder that is configured to co ver the shell and its rim.
  • a further object of the invention is to disclose the socket provided with at least one ventilation opening.
  • a further object of the invention is to disclose the socket having an internal surface assisting ventilation and massage of the residual limb.
  • a further object of the invention is to disclose the prosthetic apparatus further comprising an embedded actuator to stimulate blood flow within the residual limb.
  • a further object of the invention is to disclose each pair of said implantable and external parts provided with tags thereon indicating a fit in form factor thereof.
  • a further object of the invention is to disclose the tags being machine-readable without direct contact, including RFID tags.
  • a further object of the invention is to disclose a method of installing a prosthetic assembly for a lower residual limb.
  • the aforesaid method comprises the steps of: (a) choosing a shell-socket assembly from a limited list of assembly sizes according to physical characteristics of the amputee; (b) providing an implantable assembly further comprising (i) an anchor being anchorable within an amputee's residual limb bone; and (ii) a shell mechanically connectable to the anchor; and (iii) an adjustment bladder connectable to the shell; (c) implanting the implantable assembly into the residual limb; (d) following a period of cicatrization after the amputation and implantation, inserting the residual limb into an external assembly; and (d) securing the residual limb within the external assembly.
  • a further object of the invention is to disclose a method of installing a prosthesis onto a lower residual limb.
  • the aforesaid method comprises the steps of: (a) choosing a form-factor of said prosthesis according to at least one physical characteristic of the amputee; (b) providing a prosthetic apparatus further comprising an implantable part further comprising (1) an anchor being anchorable within an amputee's residual limb bone; (2) a shell mechanically connectable to said anchor; and (3) an adjusting bladder; (c) implanting said implantable part of said chosen form- factor into said residual limb.
  • the shell is conformably configured to the socket such that a substantially full contact therebetween is provided.
  • a further object of the invention is to disclose a method of installing a prosthesis onto a lower residual limb.
  • the aforesaid method comprises the steps of: (a) choosing an assembly of shell and socket from a limited list of sizes according to physical characteristics of the amputee; (b) providing a prosthetic apparatus further comprising (i) an implantable part further comprising (1) an anchor being anchorable within an amputee's residual limb bone; and (2) a shell mechanically connectable to the anchor; and (3) an adjustment bladder connectable to the shell; (ii) an external part further comprising (1) a socket receiving the residual limb thereinto; (2) a clamping mechanism securing the residual limb in the socket; and (3) an elongated supporting member; implanting the implantable arrangement into the residual limb; (c) implanting the implantable part into the residual limb; (d) following a period for cicatrization after the amputation and
  • the shell and socket are conformably configured to each other such that a substantially full contact therebetween is provided.
  • a further object of the invention is to disclose the method comprising a step of form-factoring each pair of the shell and socket depending on at least one physical characteristic of the amputee.
  • a further object of the invention is to disclose the method comprising steps of distributing a pressure of the amputee's weight over the contact area between the socket and shell in order to minimize the local pressure on the contacting skin.
  • a further object of the invention is to disclose a method of installing a prosthesis onto a lower residual limb.
  • the aforesaid method comprises the steps of: (a) choosing a shell according to physical characteristics of the amputee; (b) providing a prosthetic apparatus further comprising (i) an implantable part further comprising (1) an anchor being anchorable within an amputee's residual limb bone; and (2) a shell mechanically connectable to the anchor; and (3) an adjustment bladder connectable to the shell; (ii) an external part further comprising (1) a socket that is designed to receive the residual limb thereinto; (2) a clamping mechanism securing the residual limb in the socket; and (3) an elongated supporting member; implanting the implantable arrangement into the residual limb; (c) implanting the implantable part into the residual limb; (d) following a period for cicatrization after the amputation and implantation - allowing for inserting the residual limb into the external assembly; and (e) securing the residual limb within the external
  • a further object of the invention is to disclose the method further comprising a step of subcutaneously implanting a bladder fillable with a variable amount of the hydrostatic fluid.
  • a further object of the invention is to disclose the step of compensating for variations in any dimension of the residual limb comprising varying the amount of the fluid within the bladder by means of transferring a hydrostatic fluid between a substantially flexible container and the bladder.
  • a further object of the invention is to disclose the step of securing the residual limb within the external assembly performed by the clamping mechanism configured for securing on the ring-like cushion.
  • a further object of the invention is to disclose the method comprising a step of ventilation the residual limb within the socket through at least one ventilation opening.
  • a further object of the invention is to disclose the method comprising a step of massaging and ventilating the residual limb by means of the internal surface of the socket being hairy or porous.
  • a further object of the invention is to disclose the method comprising a step of mechanically stimulating angiogenesis and blood flow within the residual limb by means of an embedded actuator such as a vibrator.
  • Fig. 1 is a schematic cross sectional view of an implantable portion of the prosthesis
  • Fig. 2 is a schematic cross sectional view of an outer portion of the prosthesis
  • Fig. 3 is a schematic cross secti onal view of an implantable portion of the prosthesis that is loosely configured to a prosthesis socket; and Figs. 4 and 5 flowcharts of alternative embodiments of a method of installing an implant and a prosthesis onto a lower residual limb.
  • form-factor refers to a parameter characterizing the geometric dimensions of the prosthesis components.
  • a value of the form-factor depends on physical characteristics of the amputee. In an exemplary manner, a greater form-factor corresponds to prosthesis of larger size provided to an amputee of heavier weight while a smaller form-factor corresponds to prosthesis of smaller size provided to an amputee of lighter weight.
  • form factoring refers to a procedure of selecting sizes of a shell and accordingly a socket which are appropriate to a specific amputee from a plurality of standard sizes.
  • the following factors can be accountable in the procedure: a weight of the amputee, a diameter of the internal bone, a diameter of the residual limb, an amount of muscle tissue of a residual limb and an expected pressure applied to the shell according to an amputee's lifestyle.
  • the present invention is directed to facilitating a procedure of fitting of the lower limb prosthesis for a specific amputee.
  • the residual limb is configured into a standard shape by an implanted part and the prosthesis having a socket adapted for receiving the standard residual limb and securing the prosthesis on the residual limb is provided to the amputee.
  • the residual limb and receiving socket are configured with a variable form factor according to physical characteristics of the amputee (for example, his/her weight).
  • Fig. 1 presenting a residual limb 100 in which an implantable arrangement is installed.
  • a main implant anchor 30 is anchored within a residual bone 10.
  • a shell 50 is mechanically connected to the anchor 30 by means of a connecting member 40 and defines a surface of the amputee's residual limb (cutaneous covering 20).
  • the anchor 30 is reliably fixed to the bone 10. However, the bone 10 is protected against damage due to shock or pressure.
  • the shell 50 includes a shock absorber to limit the effect of a shock, such that might be endured by a jump.
  • the connecting member 40 is designed to break under specific force to protect the bone-screw interface.
  • bladder 60 is subcutaneously attachable to the implant shell 50.
  • the bladder 60 is designed for compensating for volume fluctuations in a residual limb.
  • the bladder 60 distributes the amputee's weight force over an internal surface of the socket (not shown) and provides a comfortable contact between the residual limb and the socket receiving the residual l imb.
  • the bladder 60 i s provided to even the distribution of pressure of the amputee's weight over the socket 220 area and its edge 65provides a cushion for clamping mechanism 210 (not shown).
  • a fluid container 70 accommodating a hydrostatic fluid is fluidly connected to the bladder 60 by means of a connecting pipe 90. A flow through the pipe 90 is controlled by a valve 80.
  • the fluid container 70 is substantially flexible to be manually pressed such that the fluid can flow between the container and the bladder.
  • An amount of the hydrostatic liquid within the bladder can be adjusted by switching the valve 80 in two modes. Specifically, concurrently pressing onto the container 70 and switching the valve into the opened position causes increase in the liquid amount due to fluid shift from container 70 into the bladder 60. If the valve 80 is opened while pressing onto the bladder 60, the fluid shifts from the bladder 60 into the container 70 and liquid amount within the bladder 60 is decreased.
  • the hydrostatic fluid is a gel, including a silicon gel.
  • the element 120 is designed as a manually or machine-readable tag indicating a specific form factor of the article.
  • Fig. 2 presenting an external assembly 200 of the prosthetic device.
  • the residual limb 100 is insertable into assembly 200.
  • the aforesaid assembly 200 comprises a socket body 220 and a liner 230 attached to an internal surface of the socket body 220.
  • the aforesaid socket body 220 is provided with at least one ventilation opening 240.
  • the ventilation openings 240 provide easy filling of the socket body 220 with air when the residual limb 100 (not shown) is withdrawn and its easy escape from the socket body 220 when the socket body leans on the residual limb 100 again.
  • the element 120 is designed as a manually or machine-readable tag indicating the specific form factor of the article.
  • the assembly 200 is provided with a clamping mechanism 210 fixing the residual limb in the socket.
  • the mechanism 210 is designed for reliable securing the residual limb 100 within the socket body 220 by means of the ring-like cushion 65. so that the prosthetic device can be easily and comfortably locked onto that upper side.
  • the assembly 200 is secured on the residual limb 100 due to slip-free engagement on the relief of the ring-like cushion 65. It should be emphasized that the aforesaid slip-free engagement is realized by means of substantially smaller detent force in comparison with securing the socket on the residual limb due to the friction force over a relief-free surface of residual limb.
  • the socket body 220 has an internal hairy or fibrous or reticulate or woven or pimpled, raised, needled , open sponged surface assisting ventilation and massage of the residual limb due to providing a gap between the aforesaid surface and the residual limb 200 to enable ventilation and massage effect.
  • a small fan can be integrated into the prosthetic device to generate an air flow.
  • the fan can be powered by batteries or by a mechanism converting the walking and stepping motion into power.
  • the socket body 220 is provided with an elongated supporting member 250.
  • the aforesaid member 250 is provided with a groove 260 designed for limiting a peak force applied to the socket body 220. If the peak force exceeds a predetermined value, the member 250 is broken at the groove 260.
  • the prosthesis of the present invention advantageously differs from the prior art because it enables an amputee put on and take off the external part easily.
  • the socket is mechanically clamped (suspended) to the implanted shell, which is anchored to the amputee's bone.
  • This technical solution distincti vely differs from frictional fixation of the prosthesis on the residual limb, where a silicon sock is used as a friction lining.
  • Another aspect of the present invention constitutes in that pathological changes within the residual limb cannot influence the fitting of the residual limb to the socket.
  • the shape and dimensions of the residual limb are completely defined by the mechanically stable metal shell. Thus, there is no need to frequently provide new prostheses because of changes in the shape and dimensions of the residual limb.
  • Angiogenesis and blood flow can be encouraged by implementing mechanical stimulation on the amputated bone, which will simulate the natural stimulation of a functioning limb.
  • Applying shock waves to an area that suffers from clogged veins can significantly improve poor blood flow, typical in diabetes and other medical conditions.
  • Applying such shock waves by a system such as a lithotripter directly on the implant can transfer the therapeutic stimulation along the amputated bone and help maintain a healthy blood flow.
  • both the prosthetic apparatus en bloc and the implantable assembly and lower limb prosthesis in an individual manner are objects of legal protection.
  • Fig. 3 presenting an alternative embodiment of the implantable arrangement which, contrary to the abovementioned, is characterized by a smaller shell member 50a.
  • the shell member 50a provides a support for at least a part of pressure on the lower residual limb while, in the embodiment of Fig. 1, the shell is large enough to support also the torques that are caused by walking.
  • the shell member 50a transfers at least partially the amputee's weight directly to the lower limb bone, while the walking torques are transferred from the socket via the clamping sleeve to the periphery of the lower limb.
  • Fig. 4 presenting a flowchart of a method of installing a prosthetic assembly onto a lower residual limb.
  • Amputee records are analyzed with respect to his/her weight, diameter of the internal bone, diameter of the residual limb, and an expected pressure applied to the shell according to his/her lifestyle.
  • the step of form-factoring 310 of the prosthetic apparatus constitutes selection of an appropriate size of the prosthetic apparatus in reliance on the abovementioned amputee's parameters.
  • the prosthetic apparatus of the selected form-factor (size) is provided at step 320. Then, the implantable part is implanted into the residual limb (step 330).
  • the residual limb can be inserted into the socket of the prosthetic apparatus (step 340).
  • the fluid amount within the bladder is adjusted to provide a uniform pressure distribution of the internal surface of the socket (step 350).
  • the residual limb is secured wi thin the socket of the ex ternal part by means of the clamping mechanism (step 360). After securing the external part of the prosthetic apparatus, the amputee is ready for ambulation.
  • Fig. 5 presenting an alternative method 400 of installing a prosthetic assembly onto a lower residual limb.
  • a matchable implantable arrangement is selected (410) and provided (420). Then, the aforesaid arrangement is implanted into the residual limb (430). Following cicatrization period after amputation and implantation, a clamping sleeve and a socket to the residual limb are fitted (440).
  • the steps of adjusting the fluid amount within the bladder to provide the comfortable contact 450 and securing the residual limb within said external assembly 460 are similar to the steps 350 and 360 of the flowchart in Fig. 4.
  • an implantable assembly configured to be implanted into an amputee's residual limb.
  • the aforesaid implantable assembly comprises an implantable part further comprising (a) an anchor being anchorable within an amputee's residual limb bone; and (b) a shell mechanically connectable to the anchor.
  • the shell is conformably configured to the socket such that a comfortable contact therebetween is provided.
  • a prosthetic apparatus installable onto an amputee's residual limb comprises (a) an implantable part further comprising (i) an anchor being anchorable within an amputee's residual limb bone; and (ii) a shell mechanically connectable to the anchor; and (iii) an adjustment bladder connectable to the shell (b) an external part further comprising (i) a socket receiving the residual limb thereinto; (ii) a clamping mechanism securing the residual limb in the socket; and (iii) an elongated supporting member.
  • the shell and socket are conformably configured to each other such that a substantially full contact therebetween is provided.
  • a shell is designed for implanting into a residual limb.
  • the shell is mechanically connectable to a bone anchor.
  • the shel l is conformably configured to the socket such that a comfortable contact therebetween is provided.
  • a socket is designed for receiving a residual limb thereinto.
  • a lower limb prosthesis comprises (i) a socket receiving a residual limb thereinto; (ii) a clamping mechanism securing said residual limb in said socket; and (iii) an elongated supporting member.
  • each pair of the shell and socket is characterized by a form-factor depending on at least one physical characteristic of the amputee.
  • the form factor possesses a number of preset standard values.
  • the characteristic is selected form the group consisting of a weight of the amputee, a diameter of the internal bone, a diameter of the residual limb, a volume of muscle tissue, an expected pressure applied to the shell according to an amputee's lifestyle and any combination thereof
  • the prosthetic apparatus comprises a bladder fillable with a variable amount of the hydrostatic fluid to fill the volume between the residual limb and socket fully, thus distributing the body weight pressure over the full area of the overlap between the socket and shell.
  • the bladder volume can be changed to compensate for variations of any dimensions of the residual limb to maintain a complete contact between the residual limb and socket.
  • the bladder is subcutaneously attached to the shell.
  • the bladder is made of self sealing material and adapted for variation of accommodated fluid by means of insertion and drainage thereof through a syringe needle.
  • the prosthetic apparatus comprises a container additionally accommodating the hydrostatic fluid.
  • the container is interconnected with the bladder by means of a pipe; the pipe is provided with a valve configured to allow or block a flow between the container and the bladder.
  • the container is substantially flexible to release the fluid to the bladder and receive the fluid from the bladder.
  • the bladder is configured to cover both the shell and its rim.
  • the prosthetic apparatus is provided with a ring-like cushion disposed at a rim of the bladder.
  • shapes of the shell and socket are configured for a preferred directional attachment.
  • the ring-like cushion is filled with a fluid.
  • the ring-like cushion and the bladder are integrally inflatable.
  • the clamping mechanism is configured for securing on the ring-like cushion.
  • the clamping mechanism is a clamping sleeve configured for securing the prosthesis conformably on the lower limb.
  • the socket is provided with at least one ventilation opening.
  • the socket has an internal surface assisting ventilation and massage of the residual limb.
  • the prosthetic apparatus further comprises an embedded vibrator to stimulate blood flow within the residual limb.
  • each pair of the implantable and external parts are provided with tags thereon indicating a form factor thereof.
  • the tags are machine-readable including RFID tags.
  • said shell and socket are of a conforming rotund shape.
  • a cross-section of said shell and socket is circle-like or ellipse-like.
  • said external part is mechanically connectable to said residual limb in a releasable manner.
  • the mechanical connection is provided by mechanical fixation at a local recess/protrusion, vacuum or magnetic clamping device.
  • releasabl e connection of said external part to said residual limb is performed manually by said amputee.
  • an internal surface of sai d socket is in releasable contact with a skin surface defined said shell covered with said adjusting bladder.
  • said external part is replaceable as needed.
  • a method of installing a prosthetic assembly onto a lower residual limb comprises the steps of: (a) providing an implantable assembly further comprising (i) an anchor being anchorable within an amputee's residual limb bone; and (ii) a shell mechanically connectable to the anchor; and (iii) an adjustment bladder connectable to the shell; (b) implanting the implantable assembly into the residual limb; (b) cicatrizing the residual limb; (c) following a healing period after the amputation and implantation - inserting the residual limb into an external assembly; and (d) securing the residual limb within the external assembly.
  • the shell is conformably configured to the socket such that a substantially full contact therebetween is provided.
  • a method of installing a prosthesis onto a lower residual limb comprises the steps of: (a) providing a prosthetic apparatus further comprising (i) an implantable part further comprising (1) an anchor being anchorable within an amputee's residual limb bone; and (2) a shell mechanically connectable to the anchor; and (3) an adjustment bladder connectable to the shell; (ii) an external part further comprising (1) a socket receiving the residual limb thereinto; (2) a clamping mechanism securing the residual limb in the socket; and (3) an elongated supporting member; implanting the implantable arrangement into the residual limb; (b) implanting the implantable part into the residual limb; (c) following a healing period after the amputation and implantation, inserting the residual limb into the external assembly; and (e) securing the residual limb within the external assembly. It is a further core feature of the present method to provide an overall surface dimension of a lower portion of the residual
  • a method of installing a prosthesis onto a lower residual limb comprises the steps of: (a) choosing a form-factor of said prosthesis according to at least one physical characteristic of the amputee; (b) providing a prosthetic apparatus further comprising an implantable part further comprising (1) an anchor being anchorable within an amputee's residual limb bone; (2) a shell mechanically connectable to said anchor; and (3) an adjusting bladder; (c) implanting said implantable part of said chosen form- factor onto the bone of said residual limb. It is a further core feature of the present method to provide an overall surface dimension of a lower portion of said residual limb inserted into said socket as defined by said shell; said shell and socket are conformably configured to each other such that a comfortable contact therebetween is provided.
  • the method comprises a step of form-factoring each pair of the shell and socket depending on at least one physical characteristic of the amputee.
  • the method comprises steps of distributing a pressure of the amputee's weight over a contact area between the socket and shell and compensating temporary or lingering variation of any dimension of the residual limb to provide a substantially full contact between the residual limb and socket.
  • the method comprises steps of transferring torques caused during the amputee's walk to the lower limb periphery via a clamping sleeve that tightens the contact between the socket and shell to provide a substantially full contact between the residual limb and socket.
  • the method further comprises a step of subcutaneously implanting a bladder tillable with a variable amount of the hydrostatic fluid.
  • the step of compensating dimension variation comprises varying amount of the fluid accommodating within the bladder by means of releasing a fluid from a substantially flexible container the bladder and to receiving the fluid from the bladder into container.
  • the step of securing the residual limb within the external assembly is performed by the clamping mechanism configured for securing on the ring-ring-like cushion.
  • the method comprises a step of ventilation the residual limb within the socket through at least one ventilation opening.
  • the method comprises a step of massaging and ventilating the residual limb by means of an internal hairy or porous surface of the socket.
  • the method comprises a step of mechanically stimulating angiogenesis and blood flow within the residual limb by means of an embedded actuator such as a vibrator.
  • the method comprises a step of mechanically connecting said external part to said residual limb in a releasable manner.
  • the method comprises a step of releasably connecting said external part to said residual limb performed manually by said amputee.
  • a step of connecting said external part to said residual limb is performed between an internal surface of said socket and a skin surface defined by said shell covered with said adjusting bladder.
  • the method comprises a step of replacing said external part as needed.

Landscapes

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

Abstract

L'invention concerne un ensemble implantable configuré pour être implanté dans le membre résiduel d'un amputé; ledit ensemble implantable comprenant une partie implantable, comprenant en outre a. un ancrage pouvant être ancré dans un os de membre résiduel de l'amputé ; b. une coque pouvant être reliée mécaniquement audit ancrage; et c. une vessie d'adaptation pouvant être connectée à ladite coque; où ladite coque définit une dimension de surface globale d'une partie inférieure dudit membre résiduel.
PCT/IB2015/055864 2014-08-03 2015-08-02 Prothèse d'extrémité inférieure avec coque implantée WO2016020819A1 (fr)

Applications Claiming Priority (2)

Application Number Priority Date Filing Date Title
US201462032574P 2014-08-03 2014-08-03
US62/032,574 2014-08-03

Publications (1)

Publication Number Publication Date
WO2016020819A1 true WO2016020819A1 (fr) 2016-02-11

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Citations (6)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US1057562A (en) * 1911-06-21 1913-04-01 Joseph G La Point Pneumatic cushion for stump-legs.
US4781720A (en) * 1987-02-05 1988-11-01 Sherva Parker Carole J Amputation apparatus
US5405405A (en) * 1993-05-21 1995-04-11 Love; Michael G. Prosthetic socket containing inflatable means
US6077300A (en) * 1996-04-23 2000-06-20 Novacare Orthotics & Prosthetics East, Inc. Artificial limb with anatomically configured socket
US20020077705A1 (en) * 2000-10-04 2002-06-20 Dale Perkins Attachment system for prosthesis
US20070060891A1 (en) * 2003-12-08 2007-03-15 Richard Skiera Implant with a skin penetration section

Patent Citations (6)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US1057562A (en) * 1911-06-21 1913-04-01 Joseph G La Point Pneumatic cushion for stump-legs.
US4781720A (en) * 1987-02-05 1988-11-01 Sherva Parker Carole J Amputation apparatus
US5405405A (en) * 1993-05-21 1995-04-11 Love; Michael G. Prosthetic socket containing inflatable means
US6077300A (en) * 1996-04-23 2000-06-20 Novacare Orthotics & Prosthetics East, Inc. Artificial limb with anatomically configured socket
US20020077705A1 (en) * 2000-10-04 2002-06-20 Dale Perkins Attachment system for prosthesis
US20070060891A1 (en) * 2003-12-08 2007-03-15 Richard Skiera Implant with a skin penetration section

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