WO2021252328A1 - Système d'emboîture prothétique pour prendre une empreinte 3d, ou former une emboîture prothétique autour d'un membre résiduel - Google Patents

Système d'emboîture prothétique pour prendre une empreinte 3d, ou former une emboîture prothétique autour d'un membre résiduel Download PDF

Info

Publication number
WO2021252328A1
WO2021252328A1 PCT/US2021/036118 US2021036118W WO2021252328A1 WO 2021252328 A1 WO2021252328 A1 WO 2021252328A1 US 2021036118 W US2021036118 W US 2021036118W WO 2021252328 A1 WO2021252328 A1 WO 2021252328A1
Authority
WO
WIPO (PCT)
Prior art keywords
inflatable
debatable
conformable
tubular shaped
distal end
Prior art date
Application number
PCT/US2021/036118
Other languages
English (en)
Inventor
Clifford CREEKMORE
Randy ROSENQUIST
Matthew Jore
David Reis
Original Assignee
Pc3 Innovations, 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 Pc3 Innovations, Llc. filed Critical Pc3 Innovations, Llc.
Publication of WO2021252328A1 publication Critical patent/WO2021252328A1/fr

Links

Classifications

    • B—PERFORMING OPERATIONS; TRANSPORTING
    • B33—ADDITIVE MANUFACTURING TECHNOLOGY
    • B33Y—ADDITIVE MANUFACTURING, i.e. MANUFACTURING OF THREE-DIMENSIONAL [3-D] OBJECTS BY ADDITIVE DEPOSITION, ADDITIVE AGGLOMERATION OR ADDITIVE LAYERING, e.g. BY 3-D PRINTING, STEREOLITHOGRAPHY OR SELECTIVE LASER SINTERING
    • B33Y80/00—Products made by additive manufacturing
    • 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
    • A61F2/76—Means for assembling, fitting or testing prostheses, e.g. for measuring or balancing, e.g. alignment 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
    • A61F2/78—Means for protecting prostheses or for attaching them to the body, e.g. bandages, harnesses, straps, or stockings for the limb stump
    • 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
    • B—PERFORMING OPERATIONS; TRANSPORTING
    • B29—WORKING OF PLASTICS; WORKING OF SUBSTANCES IN A PLASTIC STATE IN GENERAL
    • B29C—SHAPING OR JOINING OF PLASTICS; SHAPING OF MATERIAL IN A PLASTIC STATE, NOT OTHERWISE PROVIDED FOR; AFTER-TREATMENT OF THE SHAPED PRODUCTS, e.g. REPAIRING
    • B29C43/00—Compression moulding, i.e. applying external pressure to flow the moulding material; Apparatus therefor
    • B29C43/32—Component parts, details or accessories; Auxiliary operations
    • B29C43/36—Moulds for making articles of definite length, i.e. discrete articles

Definitions

  • the present invention is generally related to prosthetic devices, and more particularly, to a device and method for taking a casting or three-dimensional (3D) impression of, or forming a prosthetic socket about, a residual limb.
  • Prosthetic limbs are generally attached to a user’s residual limb by means of a socket that extends over and about a distal end and surrounding portions of the residual limb.
  • Prosthetic sockets were originally hand carved from wood or bone and were cushioned with leather pads. The comfort and functionality of such hand carved prosthetic sockets was very much dependent upon the skill and experience of the person carving the socket, and such sockets were frequently uncomfortable, expensive and difficult to reproduce/replace when the sockets wore out. Further, the socket utility and comfort was dependent upon the user’s residual limb not changing, such as physical transformations from losing or gaining weight. Such sockets also tended to concentrate all of the user’s weight, which was borne by the prosthetic, onto a small concentrated surface within the socket, which led to discomfort.
  • Known apparatuses and methods for forming prosthetic sockets typically provide a liner or sock that is placed over the residual limb.
  • the exterior facing surface of the liner/sock is thereafter covered with a casting material, such as, but not limited to, plaster, which is typically impregnated dry into a thin flat ribbon-shaped and wound cloth gauze material and then fully wetted and wrapped around the liner/sock and allowed to dry and harden around the residual limb; or carbon pre-preg, which is typically available in flat strips and is wrapped around the liner/sock and activated with a catalyst to harden and set around the residual limb.
  • a socket having a shape that replicates the shape of the residual limb is formed.
  • This socket may be used as a negative mold after it is removed from the residual limb.
  • the negative mold may thereafter be used to form a positive mold, typically by pouring a liquid plaster into the mold, letting it dry and set and then removing the negative mold, which replicates the physical structure, shape, configuration and size of the residual limb and distal end thereof.
  • the resulting socket may be used directly as a prosthetic socket to be attached to prosthetic limb componentry and a prosthetic foot to provide for ambulation.
  • the casting material is manually pressed/molded against and about the residual limb, and distal end thereof, by a prosthetist using hand pressure and while the patient is seated in a non-weight bearing state until the casting material sets.
  • cylinders have been employed wherein fluidic pressure is exerted against the casting material to uniformly force the casting material against the residual limb and distal end thereof.
  • prosthetic sockets tend to concentrate all, or nearly all of the user’s weight on a small area (typically the very bottom or distal end) of the residual limb where the residual limb physically contacts the interior surface of the socket. This leads to rub spots, calluses, discomfort and “hot-spots” that may lead to infections and worse.
  • a system for taking a casting or 3D impression of, or forming of a socket around, a residual limb of an amputee in a weight bearing state, said system comprising one or more tubular shaped cylinders and one or more inflatables configured to comformably receive a residual limb.
  • FIG. 1 is a schematic diagram that illustrates, in an isometric view, an embodiment of an example prosthetic socket system.
  • FIG. 2 is a schematic diagram that illustrates, in cutaway side view, certain internal components of an embodiment of an example prosthetic socket system, including inflated bladder sleeves, without a residual limb in place.
  • FIG. 3 is a schematic diagram that illustrates, in side view, an embodiment of an example prosthetic socket system including a base, enclosure, and telescoping tubular shaped cylinder structure portion extending upward from the base.
  • FIG. 4A is a schematic diagram that illustrates, in top view, an opening at the top of a telescoping tubular shaped cylinder structure portion of an embodiment of an example prosthetic socket system.
  • FIG. 4B is a schematic diagram that illustrates, in isometric cutaway view, primary inflatable components and part of a telescoping tubular shaped cylinder structure portion of an embodiment of an example prosthetic socket system.
  • FIG. 5 is a schematic diagram that illustrates, in front elevation view, an embodiment of an example prosthetic socket system with sets of linear actuators, as a lifting and lowering means attached to telescoping tubular shaped cylinder structure portions, fully retracted.
  • FIG. 6 is a schematic diagram that illustrates, in front elevation view, an embodiment of an example prosthetic socket system with a lower set of linear actuators, attached to a lower section of a telescoping tubular shaped cylinder structure portion, fully extended, and an upper set of linear actuators fully retracted.
  • FIG. 7 is a schematic diagram that illustrates, in front elevation view, an embodiment of an example prosthetic socket system with both sets of linear actuators, attached to telescoping tubular shaped cylinder structure portions, fully extended.
  • FIG. 8A is a schematic diagram that illustrates an example control function of an embodiment of an example prosthetic socket system.
  • FIG. 8B is a flow diagram that illustrates an example process involved in operating an embodiment of an example prosthetic socket system.
  • FIG. 9A is a schematic diagram that illustrates a mannequin representing a patient positioned into an embodiment of an example prosthetic socket system.
  • FIGS. 9B and 9C are schematic diagrams that each illustrate a mannequin representing a patient in position with respect to an embodiment of an example prosthetic socket system while a residual limb is being cast under a weight bearing state.
  • FIG. 10A is a schematic diagram that illustrates a mannequin representing a patient with the residual limb placed in an above knee attachment in a position above a top of a tubular shaped cylinder structure of an embodiment of an example prosthetic socket system.
  • FIGS. 10B and 10C are schematic diagrams that illustrate the above knee attachment of FIG.10A uncoupled and coupled, respectively, to a tubular shaped cylinder structure of an embodiment of an example prosthetic socket system.
  • FIG. 11A is a schematic diagram that illustrates a mannequin representing a patient with a residual limb placed into a transparent tubular shaped cylinder structure of an embodiment of an example prosthetic socket system.
  • FIG. 11 B is a schematic diagram that illustrates a mannequin representing a patient with a residual limb placed into a transparent tubular shaped cylinder structure of an embodiment of an example prosthetic socket system, with a cutaway view of a base enclosure.
  • FIG. 11 C is a schematic diagram that illustrates a residual limb placed into a transparent tubular shaped cylinder structure and sealably surrounded by a flexible sleeve liner of an embodiment of an example prosthetic socket system.
  • FIG. 12A is a schematic diagram that illustrates a partial cutaway view of a short length residual limb held in place in close proximity to a distal end carrier and distal end carrier retainer that is supported by a telescoped pedestal formed of inverted cup shaped structures in a tubular shaped structure of an embodiment of an example prosthetic socket system.
  • FIG. 12B is a schematic diagram that illustrates a partial cutaway view of a long length residual limb held in place in close proximity to a distal end carrier and distal end carrier retainer that is supported by a telescoped pedestal in retracted position in a tubular shaped structure of an embodiment of an example prosthetic socket system.
  • a prosthetic socket system and method having one or more tubular, cylinder structures and various inflatables arranged therein to enable a near net shape casting or three-dimensional (3D) impression of, or forming a socket around, a residual limb in a weight bearing state.
  • inflatables includes a volume-adjustable structure that may be inflated and deflated to enable a conforming contact with a limb of a subject, the subject being a human or animal having at least one residual limb in need of scanning and/or casting, and/or forming a socket, for eventual realization of a prosthetic limb(s).
  • volume-adjustable structures are also referred to herein as bladder sleeves, ring-shaped retainers (including distal end carrier retainers), and distal end carriers, or the like, and may be comprised of an elastomeric material, nylon material, or any combination thereof that are volume adjusted through inflation or deflation via the respective ingress or egress of a fluid (e.g., air, gas, or liquid material).
  • a single tubular, cylinder structure comprising a ring- shaped inflatable and a bladder inflatable that conformably secure a residual limb in a weight-bearing state to enable scanning and/or casting of, and/or forming a socket around, the residual limb while distributed forces are imposed on the residual limb.
  • the tubular, cylinder structure is comprised of a transparent material, enabling, for instance, a scanning operation to be implemented.
  • two tubular, cylinder structures in controllable, slidable relation to each other are disclosed, each having inflatables arranged to accommodate a wide range of residual limb dimensions.
  • a further drawback of some conventional systems is that sockets are cast while the user’s limb is not bearing weight. As a result, the muscle structure and tissue position of the limb is not oriented as it would be when the limb is in a weight bearing state. The result is that the socket is malformed for the purpose for which it is intended.
  • a still further drawback of prior techniques is that users of prosthetic limbs tend to favor, or to place, more body weight on a remaining natural limb than on a prosthetic limb. Such unequal weight distribution can lead to spinal misalignment problems and joint degeneration. It is therefore important that equal amounts of body weight are exerted on both the prosthetic limb and on the natural limb.
  • Another recognized drawback to some known prosthetic casting apparatuses and methods is that they exert uncontrolled, proximal upward pressures on the patient’s limb, which may place the patient’s skin under tension and result in bony prominences of the limb becoming more pronounced and exposed, ultimately leading to less comfort in the prosthetic socket.
  • a prosthetic socket system overcome these and other/further drawbacks by interconnecting an internal inflatable and debatable and conformable flexible bladder sleeve (also referred to herein as an inflatable or flexible bladder sleeve) to the top and bottom of the apparatus’s tubular shaped structure portion or portions to control and limit all or most upward forces exerted on the limb.
  • an internal inflatable and debatable and conformable flexible bladder sleeve also referred to herein as an inflatable or flexible bladder sleeve
  • a prosthetic socket system loads the residual limb in an optimal, controllable and measurable manner and does not create unwanted skin tension and traction.
  • a prosthetic socket system supports the residual limb utilizing compression of the soft tissues and interosseous areas between the bones, creating natural unloading of the bony prominences, while in a weight bearing state.
  • a prosthetic socket system may not require external power or water sources and can be operated utilizing a positive-displacement air pump (such as, but not limited to, a bicycle tire pump) and gravity, which allows the prosthetic socket system to meet functional and geographical needs and goals and works equally as well in remote or third world countries as it does in an advanced clinic setting.
  • a prosthetic socket system utilizes real-time measurable data to adjust settings to specific patient needs.
  • a prosthetic socket system monitors body weight on the entire system, a distal end of a residual limb (important for prosthetic fit and comfort), and patient feedback as it relates to comfort levels.
  • a prosthetic socket system has one or more lift assemblies that allow a practitioner to easily customize the apparatus to the specific patient requirements because proper orientation of the apparatus decreases the chances for patient compensation (e.g., poor alignment and weight distribution), resulting in a better fit.
  • the one or more lift assemblies reduce fall risk and discomfort to the patient and save time and effort as compared to other systems, such as systems that require blocks or stacks of plates and multiple manual adjustments to accommodate various patient heights and residual limb lengths and sizes.
  • a prosthetic socket system provides one or more tubular shaped structures that are self-contained with on-board sensors to present feedback where adjustments can be made to components by integrated controls in real time and that allows prosthetic practitioners to design prosthetic sockets with greater quality of fit, and with results that are reproducible and achieved in less time than traditional casting or 3D scanning or socket forming methods, so patients can be ambulating in a diagnostic socket within (in most circumstances) an hour of completing the process.
  • a prosthetic socket system comprises an apparatus and method for measuring multiple data parameters including, but not limited to, body weight applied to the apparatus, distal interface internal and external pressures, and internal forces, providing an ability to adjust all or certain combinations of these factors to create a casting or an impression or a socket that is shaped as close to the final weight bearing prosthetic socket as possible by loading the patient’s residual limb in a premeditated, calculated, controllable, and reproducible way.
  • a prosthetic socket system comprises a full-length inflatable and debatable and conformable flexible bladder sleeve(s) inside one or more tubular shaped cylinder structures which may be used in conjunction with an internal distal end lift assembly to control an amount of volume that is under the patient and enables more pressure or force to be applied to, for instance, a wet distal cast.
  • An inner lift assembly may control the volume of air and allow more or less pressure where it is needed.
  • the prosthetic socket system is depicted as having a telescoping, multi-cylinder assembly comprising a lower tubular shaped cylinder structure 1 having an inner diameter sized to slidably receive upper tubular shaped cylinder structure 2.
  • Lower tubular shaped cylinder structure 1 is partially enclosed in a base enclosure 3 and operably coupled to plural (e.g., three, though not limited to three) linear actuators 4.
  • Lower tubular shaped cylinder structure 1 is attached to upper actuator connecting flange 6, which in turn is attached to linear actuators 4.
  • Upper tubular shaped cylinder structure 2 is attached to upper actuator connecting flange 7, which in turn is attached to plural (e.g., two, though not limited to two) linear actuators 5, which may take the form of certain linear actuators such as Part No. PA-14, provided by Progressive Automations. In some embodiments, other types of actuators may be used, including rotary actuators or actuators energized by other sources (e.g., pneumatic, hydraulic, etc.).
  • Upper actuator connecting flange 7 is attached to a ring shaped inflatable and debatable and conformable retainer 8.
  • Upper actuator connecting flange 7 has upper attachment keys 9 to hold in place and lock on a specific attachment to the top of tubular shaped cylinder structure 2.
  • base portion 11 includes linear actuator brackets 12, distal end pedestal 13, and distal end pedestal cap 14.
  • Lower telescoping base 15 supports linear actuator blocks 16.
  • Lower cylinder bladder sleeve 17 is positioned at an internal diameter of lower tubular shaped cylinder structure 1 and is sealably affixed to lower tubular shaped cylinder structure 1 at its bottom portion 2a and is inflatable through port 23 and bottom end opening 2b (tubing not shown).
  • Upper cylinder bladder sleeve 18 is positioned at the internal diameter of upper tubular shaped cylinder 2 and is inflatable/deflatable via port 24.
  • Ports 23 and 24 may be in the form of a Schrader valve, Presta valve, Dunlop valve, or other known components or assembly of components to enable the controlled ingress or egress of pressurized fluid (e.g., air, gas, liquid) into or out of the lower cylinder bladder sleeve 17 and upper cylinder bladder sleeve 18, respectively.
  • Inflatable/deflatable distal end carrier retainer 19 is positioned at the upper portion of distal end pedestal cap 14 (which also in some embodiments may be part of base portion 11 ) and encompasses inflatable/deflatable distal end carrier 20.
  • Inflatable/deflatable distal end carrier 20 is controllably inflatable or debatable through tubing (not shown in this view) passing through openings 13a, 13b in distal end pedestal 13 and distal end pedestal cap 14. Shoulder screw fasteners 21 slidably fix lower telescoping cylinder base 15 to lower tubular shaped cylinder structure 1.
  • One or more load sensors 22 may be positioned at the bottom of base enclosure 3 in communication with a surface (e.g., floor surface). Force sensor 22 may also be fixedly attached to inflatable distal end carrier 20, either at its top or beneath it.
  • FIG. 3 shows a side elevation profile wherein lower tubular shaped cylinder structure 1 is partially enclosed in base enclosure 3 and is fully retracted by linear actuators 4, and upper tubular shaped cylinder structure 2 is fully extended from lower tubular shaped cylinder structure 1 by linear actuators 5.
  • Lower actuator connecting flange 6 is fixedly attached to lower tubular shaped cylinder structure 1 and upper actuator connecting flange 7 is fixedly attached to upper tubular shaped cylinder structure 2 by fasteners 10.
  • FIG. 4A is a top view showing base enclosure 3, lower actuator connecting flange 6, upper actuator connecting flange 7, inflatable/deflatable retainer 8, lower cylinder bladder sleeve 17, upper cylinder bladder sleeve 18, inflatable/deflatable distal end carrier retainer 19, and inflatable/deflatable distal end carrier 20. In this view, all inflatables/deflatables are shown partially or fully inflated.
  • FIG. 4B is an isometric cutaway view showing various internal components, including some primary components that interface with a residual limb without showing the residual limb in place.
  • an embodiment of a prosthetic socket system comprises inflatable retainer 8 shown inflated, base portion 11 , distal end pedestal 13, distal end pedestal cap 14, lower cylinder bladder sleeve 17 shown inflated, upper cylinder bladder sleeve 18 shown inflated, inflatable distal end carrier retainer 19 shown inflated, inflatable distal end carrier 20 shown inflated, and load sensor 22 positioned in one embodiment at top center of the inflated inflatable distal end carrier 20 (load sensor 22 may also be positioned beneath distal end carrier 20).
  • FIG. 5 shows lower tubular shaped cylinder structure 1 fully retracted by linear actuators 4 and attached to lower actuator connecting flanges 6, upper tubular shaped cylinder structure 2 fully retracted by linear actuators 5 and attached to upper actuator connecting flanges 7 having upper attachment key features 9, which create a tongue and groove type contact similar to a pressure cooker and lid, with which certain attachments may be added, and base portion 11 .
  • attachment key features 9 may be replaced with other connection-facilitating features.
  • lower tubular shaped cylinder structure 1 is fully extended by linear actuators 4 and attached to lower actuator connecting flanges 6 and upper tubular shaped cylinder structure 2 is fully retracted by linear actuators 5, the upper tubular cylinder structure 2 attached to upper actuator connecting flanges 7 having upper attachment keys 9, and the assembly having base portion 11 .
  • FIG. 7 shows lower tubular shaped cylinder structure 1 fully extended by linear actuators 4 and attached to lower actuator connecting flanges 6.
  • Upper tubular shaped cylinder structure 2 is fully extended by linear actuators 5 and attached to upper actuator connecting flanges 7 having upper attachment keys 9, and the assembly having base portion 11 .
  • FIG. 8A shows an example control scheme 50 of an embodiment of a prosthetic socket system. It should be appreciated by one having ordinary skill in the art that the control scheme illustrated in FIG. 8A is one example, and that other and/or additional or fewer components may be used control the prosthetic socket system.
  • the control scheme 50 comprises a control system 52 communicatively coupled (e.g., via wired and/or wireless connections) to one or more actuators 54, airbag pressure/valve assemblies 56, which in one embodiment may be in the form of Asco mini solenoid valves, or other known components or assembly of components to enable the controlled ingress or egress of pressurized fluid (e.g., air, gas, liquid) into and out of inflatable components, and one or more sensors 58, such as Tekscan mini sensors in one embodiment or other types of sensors in some embodiments, to enable the measurement of body weight and distal end load.
  • the control scheme 50 also includes user input functionality, including for entering parameters of height of a subject, limb length, air bag pressure, and distal air bag pressure.
  • the control system 52 comprises hardware, or a combination of hardware and software, such as an iOS Uno control board or similar functionality and other components.
  • the control system 52 comprises a personal computer, laptop, workstation, programmable logic controller(s), among other computing devices.
  • the control system 52 comprises any custom made or commercially available processor, a central processing unit (CPU), a multi-core processor, a semiconductor based microprocessor (in the form of a microchip or chip set), a macroprocessor, one or more application specific integrated circuits (ASICs), one or more field programmable gate arrays (FGPAs), a plurality of suitably configured digital logic gates, and/or other well-known electrical configurations (e.g., discrete electronic circuits) that enable the functionality described below and in association with FIGS.
  • CPU central processing unit
  • ASICs application specific integrated circuits
  • FGPAs field programmable gate arrays
  • functionality of the control system 52 may be implemented using software (e.g., including firmware, middleware, op-code, etc.) that is stored on a non- transitory, computer readable (storage) medium.
  • the software may comprise a source program, executable program (object code), script, or any other entity comprising a set of instructions to be performed.
  • a source program then the program may be translated via a compiler, assembler, interpreter, or the like, so as to operate properly in connection with an operating system.
  • the software can be written as (a) an object oriented programming language, which has classes of data and methods, or (b) a procedure programming language, which has routines, subroutines, and/or functions, for example but not limited to, C, C+ +, Python, Java, among others.
  • the control system 52 may include an operating system, whereas in some embodiments, the operating system may be omitted.
  • the control system 52 comprises one or more additional components, including a power source and/or converter, among other components.
  • the control system 52 and the one or more additional components may be discrete units that are separately packaged yet coupled to each other (e.g., in an enclosure).
  • the control system 52 may further comprise an input/output (I/O) interface that is suitable to provide and receive digital and/or analog data to and from one or more devices, including the one or more actuators 54, airbag pressure/valve assemblies 56, and one or more sensors 58, and/or to/from user input devices.
  • the control system 52 may comprise further signal conditioning components, including filters, amplifiers, analog-to-digital converters (ADCs) and digital-to-analog converters (DAC).
  • control system 52 may comprise communication functionality, including a wireless modem, cellular modem, cable modem, and/or radio frequency circuitry configured according to any one or more of a plurality of standards and/or protocols, including Bluetooth (BT), low energy BT, Zigbee, RFC, 802.11 , 3G, 4G, 5G, digital subscriber line (DSL), asymmetric DSL (ADSL).
  • BT Bluetooth
  • DSL digital subscriber line
  • ADSL asymmetric DSL
  • communications may be carried out via HTTP, FTP, Ethernet-based protocols, etc.
  • the control system 52 provides and/or controls power and, in some embodiments, receives feedback, to and from the one or more actuators 54 (which may include linear actuators 4 and 5 of FIG. 3).
  • power e.g., based on 12V
  • actuators 54 may be provided to the actuators 54 to adjust a height of the tubular shaped cylinder structures 1 , 2 relative to each other
  • height feedback may be provided to the control system 52 via a 5V signal.
  • feedback may be omitted, or in some embodiments, feedback may be provided manually (e.g., from visual observation) from an operator.
  • Communication and power between the airbag pressure/valve assemblies 56 and the control system 52 may be via 4-20mA signal (or in some embodiments, 0-5V or other control schemes) and 24V power.
  • the airbag pressure/valve assemblies 56 include the inflatables described above, including the bladder sleeves, ring-shaped retainers (including distal and top rings), and the distal end carrier 20.
  • the control system 52 provides input to the sensors 58 via a predetermined voltage value (VDC REF), and receives sensor input.
  • the control system 52 further provides and/or controls power to one or more pumps (e.g., 24V power), which causes the pump(s) to provide pressurized fluid to the airbag pressure/valve assemblies 56.
  • the various input parameters may be input to the control system 52 via any one or more of a variety of mechanisms, including through hard or soft buttons (e.g., soft buttons on a display screen) or switches or dials, microphones (e.g., voice input), through mouse input (e.g., selection from a displayed list or rendered option icons), and/or keyboard entry.
  • buttons e.g., soft buttons on a display screen
  • switches or dials e.g., microphones
  • mouse input e.g., selection from a displayed list or rendered option icons
  • keyboard entry e.g., a keyboard entry.
  • One or more of these input devices may be located on a control panel or console, or in some embodiments, implemented remotely via a mobile device.
  • FIG. 8B shows a flow diagram of an example process or method 60 involved in using an embodiment of a prosthetic socket system.
  • the method 60 may be carried out at least in part using the control scheme 50 described above in association with FIG. 8A. It should be appreciated by one having ordinary skill in the art that the method 60 depicted in FIG. 8B is one example, and that in some embodiments, additional or fewer steps may be implemented.
  • the method 60 comprises receiving subject (e.g., patient) parameters (62), setting lower lift means (64) and upper lift means (66), preparing a residual limb of the subject (68), adjusting a volume of one or more inflatables and receiving the residual limb (70), adjusting a volume of a ring inflatable that circumscribes at least in part an exposed portion of the residual limb (72), re-adjusting the volume of the inflatables around the residual limb (74), reducing a volume around a distal portion of the residual limb (76), retaining the state for a time period (78), and reducing a volume of the inflatables after a cast is set (80).
  • subject e.g., patient
  • upper lift means e.g., patient
  • patient parameters that are inputted to the control system 52 include the height of the subject, weight of the subject, residual limb length and diameter, among other parameters. These inputted parameters are recorded (e.g., in memory of the control system 52).
  • the lower lift means is set to a value commensurate with the subject’s height (64) and the upper lift means is set to a value commensurate with the residual limb length (66) of the subject.
  • the residual limb preparation (68) the residual limb is cast-prepared.
  • the inflatables may comprise the distal end carrier 20, the distal end carrier retainer 19, the top ring-shaped inflatable retainer 8, and the upper and lower cylinder bladder sleeves 18, 17.
  • a cast-prepared residual limb of a subject is placed into the upper tubular shaped cylinder structure 2, centered on, and in light contact with, the distal end carrier 20, with the subject balancing and supporting his or her weight through the use of an aid, including a walker or other support means.
  • the top ring shaped retainer 8 is inflated until firm contact is made with the residual limb that is outside of the upper tubular shaped cylinder structure 2 (e.g., part of the upper, residual limb that is exposed).
  • the upper and low cylinder bladder sleeves 18, 17 are inflated to respectively compress against the residual limb to a predetermined pressure so that the subject’s entire weight may be applied to the upper and low cylinder bladder sleeves 18, 17 without increasing contact or weight on the distal end carrier 20.
  • the pressure in the distal end carrier 20 and the distal end carrier retainer 19 is reduced until the load sensor 22 indicates a zero load (76).
  • This state (from 76) is retained for a time period (78), the time period being for a predetermined time (e.g., 5 minutes) or conditional (e.g., until the casting material is set).
  • a predetermined time e.g., 5 minutes
  • conditional e.g., until the casting material is set.
  • the inflatables are deflated, and the residual limb is removed from the upper tubular shaped structure 2.
  • FIG. 9A shows a mannequin representing a subject/patient in position while a residual limb is being cast under a weight bearing state in an embodiment of a prosthetic socket system. Additionally shown is equipment comprising a valve actuator bank 28, pump 25, controller 26, and battery 27. It is noted that base enclosure 3 is omitted here to reveal the equipment described above.
  • FIGS. 9B-9C further show front and side views, respectively, of a mannequin representing a subject/patient in position in a prosthetic socket system while a residual limb is being cast under a weight bearing state.
  • FIG. 10A shows a mannequin representing a subject/patient in position in an embodiment of a prosthetic socket system having a tubular shaped above knee attachment 29.
  • a prosthetic socket system may be configured for below-knee residual limbs, and some embodiments may be configured for above-knee residual limbs using the above knee attachment 29.
  • FIGS. 10B-10C show the prosthetic socket system of FIG. 10A, with the knee attachment 29 shown in one view (FIG. 10B) in a position above the top of the upper tubular shaped cylinder structure 2, ready to be lowered, and another view (FIG. 10C) showing the above knee attachment 29 fixedly attached to the top of upper tubular shaped cylinder structure 2.
  • FIG. 11A shows a mannequin representing a subject/patient in position in an embodiment of a prosthetic socket system having a transparent tubular shaped cylinder structure 30 with residual limb placed into said transparent tubular shaped cylinder structure 30, with residual limb extending inside transparent tubular shaped cylinder structure 30 and surrounded by flexible sleeve liner 31 (best shown in FIGS. 11 B and 11 C) and held in place by ring shaped clamp retainer 32. Also shown is handheld (3D) scanner 33.
  • FIG. 11 B shows another view of a mannequin representing a subject/patient in position in an embodiment of a prosthetic socket system having transparent tubular shaped cylinder structure 30 with residual limb placed into and extending into the inside diameter of said transparent tubular shaped cylinder structure 30 and surrounded by flexible sleeve liner 31 and held in place by ring shaped clamp retainer 32.
  • handheld (3D) scanner 33 which may take the form of an Insignia laser scanner, a Spectra 3D scanner, or other scanner used to take a 3D impression of a residual limb under a weight bearing state.
  • FIG. 11 C shows a residual limb in position in an embodiment of a prosthetic socket system having a transparent tubular shaped cylinder structure 30, said residual limb placed into transparent tubular shaped cylinder structure 30 and sealably surrounded by flexible sleeve liner 31 , flexible sleeve liner 31 folded around the top rim of transparent tubular shaped cylinder structure 30 and clamped into position by retaining means 32, which may in one embodiment take the form of half-circle clamps (e.g., half-ring shaped clamps) adjustably fastened around a certain length of the upper portion of flexible sleeve liner 31 that is folded over the top of transparent tubular shaped cylinder structure 30.
  • half-circle clamps e.g., half-ring shaped clamps
  • This arrangement enables flexible sleeve liner 31 to have a length corresponding to the length of a residual limb inside transparent tubular shaped cylinder structure 30. Also shown is handheld scanner 33 and a partial cutaway view of transparent tubular shaped cylinder structure 30 and base enclosure 3 with lifting means 34, which take the form of an accordion shaped inflatable bladder (best shown in FIG. 12A) and which allows transparent tubular cylinder structure 30 to be lifted within base enclosure 3 to accommodate various heights of patients and lengths of residual limbs.
  • FIG. 12A shows a partial cutaway view of a short length residual limb held in place by ring shaped bladder structure 38 (e.g., versus half-ring shaped clamp 32 of FIG. 11 C) and in close proximity to distal end carrier 20 and distal end carrier retainer 19, which are supported by telescoping pedestal 37 formed of inverted cup shaped structures (shown telescoped) positioned inside tubular shaped structure 35.
  • the tubular shaped structure 35 comprises an inflatable and debatable and conformable flexible bladder sleeve 36 covering its inside diameter and sealably fixed at each end.
  • bladder structure 38 is configured to be inflated via fluid (e.g., air) conveyed through a tube or hose (not shown to avoid obscuring relevant features) that traverses the cylinder from the base enclosure to a port of bladder structure 38.
  • fluid e.g., air
  • tube or hose not shown to avoid obscuring relevant features
  • FIG. 12B shows a partial cutaway view of a long length residual limb held in place by ring shaped bladder structure 38 and in close proximity to distal end carrier 20 and distal end carrier retainer 19, which are supported by telescoping pedestal 37 formed of inverted cup shaped structures (shown untelescoped with pedestal cup 37a visible) positioned inside tubular shaped structure 35, tubular shaped structure 35 having an inflatable and debatable and conformable flexible bladder sleeve 36 covering its inside diameter and sealably fixed at each end. Further shown is a partial cutaway view of low profile base enclosure 39 housing accordion shaped lifting bladder 34 and pump 25. These components and others not shown illustrate another embodiment of an example prosthetic socket system.
  • the prosthetic socket system provides an apparatus and method for taking a casting or 3D impression of, or forming a prosthetic socket about a residual limb, while the residual limb is in a weight bearing state.
  • the prosthetic socket system comprises tubular shaped cylinder structures 1 , 2 that collectively define an interior chamber having a top end portion defining a top orifice surrounded by a top perimeter edge, a bottom end portion, and an interior chamber having a defined interior diameter and an interior depth that extends between the top end portion and the bottom end portion.
  • the tubular shaped cylinder structures 1 , 2 further have an outwardly facing surface and an inwardly facing surface, and the tubular shaped cylinder structures 1 , 2 define plural ports 23, 24 that communicate between the outwardly facing surface and the interior chamber of the tubular shaped cylinder structures 1 , 2.
  • Flexible bladder sleeves 17, 18 cover the entire inside diameter walls of each of tubular shaped cylinder structures 1 ,2 and are sealably affixed to the top end portion and the bottom end portion of each of tubular shaped cylinder structures 1 ,2 by securing band or flange 7, and a slip flange 6.
  • the flexible bladder sleeves 17, 18 form a sealed channel in the space between flexible bladder sleeves 17,18 and the inside diameter walls of tubular shaped cylinder structures 1 ,2.
  • Slip flanges 6, 7 may include plural fastener holes.
  • Tubular shaped cylinder structure 1 has a bottom end portion 2a which supports distal end pedestal 13.
  • a generally planar base is located at base portion 11 proximal to lower tubular shaped cylinder structure 1.
  • Base portion 11 has opposing top and bottom surfaces, a peripheral edge, an exterior diametric dimension that is larger than an exterior diametric dimension of tubular shaped cylinder structure 1 , and base portion 11 may include plural holes for fasteners to secure linear actuators 4 to said base portion 11 .
  • One or more of load sensor 22, which may take the form of Tekscan mini sensors, may be positioned beneath base portion 11 and adjacent the bottom surface thereof to sense downward pressure/weight exerted upon tubular shaped cylinder structures 1 , 2, and the one or more load sensors may include load sensor 22, positioned upon distal end pedestal 13 or distal end carrier 20.
  • Distal end pedestal 13, distal end pedestal cap, distal end carrier 20, and distal end carrier retainer 19 are positioned on top of the upper side of bottom end portion 2a and carried within the interior chamber of the tubular shaped cylinder structures 1 , 2.
  • a ring shaped inflatable and debatable and conformable retainer 8 when inflated, substantially seals the top orifice of the interior chamber about the residual limb.
  • a concave depression and a known radius may be carried on the upper surface of distal end pedestal cap 14, providing a feature having angular side walls that control the inward expansion of flexible bladder sleeves 17, 18 to a desired location at the interface of the residual limb.
  • Linear actuators 4, 5 attach to connecting flanges 6,7 and to base portion 11 and base enclosure 3 to controllably, vertically, and adjustably move and positionally maintain the height of tubular shaped cylinder structures 1 , 2 and the distal end pedestal 13 within the interior chamber of the tubular shaped cylinder structures 1 , 2 at any predetermined or desired position.
  • Load sensor 22 may be positioned on or beneath distal end carrier 20 to sense an amount of weight exerted upon distal end carrier 20.
  • Flexible bladder sleeves 17, 18 are carried within the interior chamber of each of tubular shaped cylinder structures 1 , 2.
  • Pump 25 pneumatically communicates through tubing and valve actuator bank 28 with the interior of the tubular shaped cylinder structures 1 , 2 to pressurize the channel between the inwardly facing surface of tubular shaped cylinder structures 1 , 2 and the outwardly facing surface of flexible bladder sleeves 17,18
  • a pressure gauge as part of valve actuator bank 28, monitors pressure within the channel between the inwardly facing surface of tubular shaped cylinder structures 1 ,2 and the outwardly facing surface of flexible bladder sleeves 17,18.
  • a controller operatively communicates with linear actuators 4, 5 for vertically adjustably positioning the height of tubular shaped cylinder structures 1 , 2 relative to a predetermined or observed desired position.
  • load sensor 22 may be positioned beneath base portion 11 to measure the amount of weight exerted upon tubular shaped cylinder structures 1 , 2.
  • One or more load sensor 22 may be positioned on top of or beneath distal end carrier 20 to measure the amount of weight on the distal end of the residual limb.
  • Certain embodiments of the prosthetic socket system further comprises ring shaped inflatable and debatable and conformable retainer 8 that attaches to a top perimeter edge of a top orifice of tubular shaped cylinder structure 2 with a fastener, and further having an outer circumferential surface that is proximate to a top end portion of tubular shaped cylinder structure 2 and an inner circumferential surface that is variable in diameter and is proximate to the residual limb.
  • Certain embodiments of the prosthetic socket system further comprises a limb liner 31 that may be placed over and about the distal end portion of the patient’s limb; and casting material may be positioned over and about the limb liner 31 , and a thin liquid impermeable barrier may be placed over the casting material to prevent casting material from contaminating the casting apparatus, and the casting material may consolidate or harden to form the prosthetic socket while under a weight bearing state and under a known compression.
  • references to “one embodiment”, “an embodiment”, or “embodiments” mean that the feature or features being referred to are included in at least one embodiment of the technology.
  • references to “one embodiment”, “an embodiment”, or “embodiments” in this description do not necessarily refer to the same embodiment and are also not mutually exclusive unless so stated and/or except as will be readily apparent to those skilled in the art from the description.
  • a feature, structure, act, etc. described in one embodiment may also be included in other embodiments, but is not necessarily included.
  • the present technology can include a variety of combinations and/or integrations of the embodiments described herein.

Landscapes

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

Abstract

Dans un mode de réalisation, un système pour prendre un moulage ou une empreinte 3D d'un membre résiduel d'un amputé dans un état de support de poids, ledit système comprenant un ou plusieurs cylindres de forme tubulaire (1, 2) et un ou plusieurs composants gonflables (17, 18) conçus pour recevoir de manière combinée un membre résiduel.
PCT/US2021/036118 2020-06-12 2021-06-07 Système d'emboîture prothétique pour prendre une empreinte 3d, ou former une emboîture prothétique autour d'un membre résiduel WO2021252328A1 (fr)

Applications Claiming Priority (2)

Application Number Priority Date Filing Date Title
US202063038144P 2020-06-12 2020-06-12
US63/038,144 2020-06-12

Publications (1)

Publication Number Publication Date
WO2021252328A1 true WO2021252328A1 (fr) 2021-12-16

Family

ID=78845854

Family Applications (1)

Application Number Title Priority Date Filing Date
PCT/US2021/036118 WO2021252328A1 (fr) 2020-06-12 2021-06-07 Système d'emboîture prothétique pour prendre une empreinte 3d, ou former une emboîture prothétique autour d'un membre résiduel

Country Status (1)

Country Link
WO (1) WO2021252328A1 (fr)

Citations (5)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US5503543A (en) * 1994-09-29 1996-04-02 Laghi; Aldo A. Prosthetic casting machine
US5718925A (en) * 1995-11-15 1998-02-17 Ossur Hf. Apparatus for making a prosthesis socket
US20150118338A1 (en) * 2012-03-13 2015-04-30 Silvio GALFIONE Machine for forming a cast of an end portion of an amputated limb
US20180036144A1 (en) * 2015-02-26 2018-02-08 Andreas Radspieler Apparatus, set and method for creating a plaster impression of a limb stump of a patient for manufacturing a prosthesis shaft and adaptor
US20200368044A1 (en) * 2019-05-24 2020-11-26 PC3 Innovations, LLC Prosthetic socket casting cylinder and method

Patent Citations (5)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US5503543A (en) * 1994-09-29 1996-04-02 Laghi; Aldo A. Prosthetic casting machine
US5718925A (en) * 1995-11-15 1998-02-17 Ossur Hf. Apparatus for making a prosthesis socket
US20150118338A1 (en) * 2012-03-13 2015-04-30 Silvio GALFIONE Machine for forming a cast of an end portion of an amputated limb
US20180036144A1 (en) * 2015-02-26 2018-02-08 Andreas Radspieler Apparatus, set and method for creating a plaster impression of a limb stump of a patient for manufacturing a prosthesis shaft and adaptor
US20200368044A1 (en) * 2019-05-24 2020-11-26 PC3 Innovations, LLC Prosthetic socket casting cylinder and method

Similar Documents

Publication Publication Date Title
US5507836A (en) Adjustable thigh prosthesis for compensation of volume variations and imposing femur adduction
EP0954258B1 (fr) Procede et dispositif de realisation d'emboiture de prothese
US11090171B2 (en) Apparatus, set and method for creating a plaster impression of a limb stump of a patient for manufacturing a prosthesis shaft and adaptor
US5503543A (en) Prosthetic casting machine
JP2006501940A (ja) 複数の加圧チャンバを有する補綴ソケット直接注型装置
US20130218296A1 (en) Adjustable prosthetic socket and suspension system
US20110071649A1 (en) Prosthetic Socket Liner
GB2149309A (en) Making artificial limbs
US20110118853A1 (en) Prosthetic Socket Stabilization Apparatus and Technique
EP3432841B1 (fr) Système de commande d'air pour améliorer une liaison entre un revêtement de membre et une prothèse de membre
CN211095865U (zh) 乳腺癌术后上肢水肿压力治疗袖带
CN115462978B (zh) 一种防褥疮床垫的皮肤压力调节控制方法
US20200368044A1 (en) Prosthetic socket casting cylinder and method
US8282686B2 (en) Prosthetic socket
CN202875727U (zh) 充气式手术床垫
WO2021252328A1 (fr) Système d'emboîture prothétique pour prendre une empreinte 3d, ou former une emboîture prothétique autour d'un membre résiduel
US20190247205A1 (en) Device for producing a plaster impression of a limb stump with connector
CN107750151B (zh) 假肢铸造装置
WO2017221019A1 (fr) Système prothétique et procédé
US20210128327A1 (en) Medical device for producing a data model of a limb stump, set, method and retaining stocking or sensor assembly
US20190307259A1 (en) Hybrid air immersion mattress
GB2116432A (en) Improved method and apparatus for manufacturing an artificial limb
CN208096823U (zh) 神经外科手术用手臂托架
CN205234832U (zh) 医用改良上肢抬高调节装置
CN206714833U (zh) 一种医疗用高舒适度支撑架

Legal Events

Date Code Title Description
121 Ep: the epo has been informed by wipo that ep was designated in this application

Ref document number: 21822662

Country of ref document: EP

Kind code of ref document: A1

NENP Non-entry into the national phase

Ref country code: DE

122 Ep: pct application non-entry in european phase

Ref document number: 21822662

Country of ref document: EP

Kind code of ref document: A1