WO2012008930A1 - Apparatuses, systems, and methods for prosthetic replacement manufacturing, temperature regulation and tactile sense duplication - Google Patents

Apparatuses, systems, and methods for prosthetic replacement manufacturing, temperature regulation and tactile sense duplication Download PDF

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Publication number
WO2012008930A1
WO2012008930A1 PCT/SG2011/000255 SG2011000255W WO2012008930A1 WO 2012008930 A1 WO2012008930 A1 WO 2012008930A1 SG 2011000255 W SG2011000255 W SG 2011000255W WO 2012008930 A1 WO2012008930 A1 WO 2012008930A1
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WO
WIPO (PCT)
Prior art keywords
temperature
sensors
prosthetic
control unit
information
Prior art date
Application number
PCT/SG2011/000255
Other languages
French (fr)
Inventor
Paragas John-John Cabibihan
Shuzhi Ge
Saba Salehi
Rangarajan Jegadeesan
Hisham Abdul Hakkim
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National University Of Singapore
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Publication of WO2012008930A1 publication Critical patent/WO2012008930A1/en

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    • GPHYSICS
    • G09EDUCATION; CRYPTOGRAPHY; DISPLAY; ADVERTISING; SEALS
    • G09BEDUCATIONAL OR DEMONSTRATION APPLIANCES; APPLIANCES FOR TEACHING, OR COMMUNICATING WITH, THE BLIND, DEAF OR MUTE; MODELS; PLANETARIA; GLOBES; MAPS; DIAGRAMS
    • G09B23/00Models for scientific, medical, or mathematical purposes, e.g. full-sized devices for demonstration purposes
    • G09B23/28Models for scientific, medical, or mathematical purposes, e.g. full-sized devices for demonstration purposes for medicine
    • G09B23/30Anatomical models

Definitions

  • This invention relates to prosthetics and more particularly relates to apparatuses, systems, and methods for prosthetic replacement manufacturing, temperature regulation and tactile sense duplication.
  • Limb amputation is an experience linked with grief, depression, anxiety, loss of self- esteem and social isolation. Amputation may be performed for medical reasons or after motor vehicle accidents, industrial and household accidents. Aesthetic prostheses significantly assist patients coping with the traumatic experience resulting from amputation. The use of certain prostheses, such as prosthetic hands, are difficult because the choices of materials available rarely allows interaction with others. That is, aside from functional limitations, the loss of a finger implies negative consequences on the person and to those around the person. For example, self- image, social, physical and practical concerns are key factors in the adjustment process for an amputee. The ability to conceal use of aesthetic prostheses allows some amputees to ward off social stigmatization, which results in better integration into society and reduction of emotional problems.
  • One shortcoming in existing prosthetic solutions is the process involved in obtaining an aesthetic prosthesis. For example, numerous doctors' appointments and fitting appointments decreases access to aesthetic prostheses for many amputees. Additionally, the aesthetic prostheses do not have a similar structure as the limb being replaced. For example, the bone structure in a human hand is different from the soft silicone present in conventional aesthetic prostheses. These differences lead to discomfort for the wearer and decreases the ability for an amputee to integrate into society. Thus, there is a need for rapid manufacturing aesthetic prostheses and improving access to aesthetic prostheses for amputees.
  • Everyday human activities are characterized by numerous touch-related experiences. Touching and being touched is an important social aspect for human beings. Touch related activities help human beings to communicate thoughts and emotions through social behavior. Humans who accidentally lose their body parts, such as arms and fingers, are limited in their expression and reception of touch and related experiences. Therefore, there is a need for prosthetic replacements to provide or receive touch sensation. Furthermore, the skin warmth when touched by another human being may be important to communicate certain thoughts and emotions. Therefore, there is a need to mimic the human body's skin temperature to bridge the differences between a human body part and a prosthetic replacement.
  • Tactile sensation is another fundamental human sense.
  • Environmental knowledge may be obtained and motions may be communicated through the sense of touch.
  • a person can tell the positions of the keys on a keyboard through tactile sensation.
  • one may also tell the emotions of a person from tactile sensation of face muscles of that person. Therefore, there is a need for prosthetic replacements to be able to duplicate tactile senses and send the duplicated senses to the amputees wearing the prosthetic replacements.
  • An embodiment of a method for manufacturing an anatomical member may include receiving electronic information defining one or more anatomical characteristics of a customer. Additionally, the method may include processing the information to generate a model of the anatomical member. In a further embodiment, the method may include forming the anatomical member from the model.
  • the anatomical unit is a prosthesis.
  • the anatomical unit is robotic.
  • the method may include providing one or more rigid structures corresponding to anatomical features of the customer defined in the electronic information. The method may also include integrating the one or more anatomical features with the anatomical member.
  • the method may include measuring temperatures of a human skin and a sample skin material, and regulating power to a heating element in the anatomical member to elevate the temperature of the prosthetic replacement to a temperature within a predetermined range of the measured human skin temperature.
  • the method may also include providing a temperature regulation unit for regulating the temperature of a surface of the anatomical member.
  • providing a temperature regulation unit further may include providing a temperature control unit, providing a temperature calibration unit configured to be coupled to the temperature control unit, and providing a power supply configured to be coupled to the temperature control unit, in which the temperature control unit regulates an output of the power supply to regulate the temperature of the prosthetic replacement.
  • the method may include providing a plurality of sensors coupled to a surface of the anatomical member, where each sensor configured to measure force in at least one direction, providing a cover coupled to the plurality of sensors, measuring an output from each of the plurality of sensors, and interpreting the output of each of the plurality of sensors to determine a characteristic of a surface in contact with the cover.
  • An embodiment of a method for manufacturing an anatomical member may include receiving information from a customer electronically. Such an embodiment may also include processing the information according to at least one of a static or dynamic model. The method may also include forming a mold for the prosthetic according to the model. Additionally, the method may include filling the mold to form the anatomical member. In one embodiment, the anatomical member is a prosthesis.
  • the method may include receiving the information comprises receiving at least one of a computed tomography (CT) scan, a photograph, personal information, payment information, and insurance information.
  • CT computed tomography
  • processing the information may include obtaining data to produce a mirror image of a remaining appendage of the customer. Additionally, processing the information may include extracting information about at least one of a bone, a bone density, a bone position, and a bone structure. Processing the information may further include extracting information about at least one of a body part, a size of a body part, a skin texture of a body part, and a skin density of a body part of the customer. Additionally, processing the information comprises designing at least one of a motor, sensor, and actuator to attach to the anatomical member.
  • the method may include attaching a ring to the anatomical member, in which the ring anchors the anatomical member to the customer.
  • the method may include receiving the information comprises receiving the information via the Internet. Additionally, the method may include shipping the anatomical member to the customer.
  • the anatomical member is a prosthetic finger.
  • the mold includes a first half and a second half coupled together by screws, a void between the first half and the second half corresponding to the shape of the anatomical member as defined by a model generated from electronic information provided by a customer, a pin for affixing a position of a bone member in the void, and injection holes for injecting material into the void.
  • the void comprises a location for at least one of a motor, an actuator, and a sensor.
  • the anatomical member is a prosthesis.
  • the anatomical member is a finger.
  • the mold comprises an interlocking ridged bonding structure.
  • the apparatus includes a temperature control unit.
  • the apparatus may also include a temperature calibration unit coupled to the temperature control unit.
  • the apparatus may include a power supply coupled to the temperature control unit, in which the temperature control unit regulates an output of the power supply to regulate the temperature of the prosthetic replacement.
  • the apparatus includes a temperature sensor coupled to the temperature control unit.
  • the temperature control unit comprises: a pulse width modulator (PWM) coupled to a power field effect transistor (FET), an analog-to- digital (ADC) converter coupled to the temperature sensor, and a programmable logic device coupled to the PWM and coupled to the ADC, in which the programmable logic device controls the PWM based, in part, on an output of the ADC.
  • PWM pulse width modulator
  • FET power field effect transistor
  • ADC analog-to- digital
  • the temperature control unit may be mounted on a flexible printed circuit board (PCB).
  • the apparatus may include a heating element coupled to the temperature control unit, in which the temperature control unit elevates the temperature of the prosthetic replacement by applying power to the heating element.
  • the temperature control unit, the temperature calibration unit, and the power supply may be attached to at least one of a wearable strap, bracelet, and watch.
  • the temperature control unit may regulate the temperature of the prosthetic replacement to substantially mimic a human skin temperature.
  • the prosthetic replacement is at least one of an arm, a hand, a finger, a toe, a foot, and a leg.
  • the temperature calibration unit may include a skin material sample substantially similar to a material of the prosthetic replacement, a temperature sensor in proximity of the sample skin material on a first side of the sample skin material, and a heating element in proximity of the sample skin material on a second side opposite the first side of the sample skin material.
  • Embodiments of a method for regulating a temperature of a prosthetic replacement includes measuring temperatures of a human skin and a sample skin material, and regulating power to a heating element in the prosthetic replacement to elevate the temperature of the prosthetic replacement to a temperature range approximately equal to the measured human skin temperature.
  • measuring the human skin temperature comprises measuring the human skin temperature with a temperature sensor embedded in a strap.
  • the method may also include applying a power level to a sample heating element in proximity to the sample skin material, measuring a calibration temperature of the sample skin material after applying the power level to the sample heating element, and determining a power output to the heating element based, in part, on the calibration temperature of the sample skin material.
  • measuring the temperature of the human skin comprises measuring the temperature of at least one of an arm, a hand, a finger, a foot, a toe, and a leg.
  • Embodiments of a method for regulating a temperature of a prosthetic replacement are also presented.
  • the method may also include measuring the ambient temperature, and regulating power to a heating element in the prosthetic replacement based, in part, on a lookup table to elevate the temperature of the prosthetic replacement to a desired temperature range.
  • the method may also include measuring human skin temperature profiles at various ambient temperatures to form the lookup table.
  • the method may include storing the lookup table in a temperature control unit.
  • regulating power to the heating element comprises estimating a duty cycle for a pulse width modulator.
  • the prosthetic replacement is at least one of an arm, a hand, a finger, a foot, a toe, and a leg.
  • the apparatus may include a plurality of sensors, each sensor configured to measure force in at least one direction, a cover coupled to the plurality of sensors, and a measurement module configured to receive information from the plurality of sensors and determine a characteristic of a surface touching the cover.
  • the cover is sulcate.
  • the cover comprises silicone rubber.
  • the cover may be flat.
  • the plurality of sensors comprises four sensors.
  • each sensor may be configured to measure force in three dimensions.
  • the characteristic may be the curvature of the surface.
  • the characteristic is the edge of the surface.
  • Embodiments of a method for measuring the contours of a surface are presented.
  • the method includes providing a plurality of sensors, where each sensor configured to measure force in at least one direction, providing a cover coupled to the plurality of sensors, measuring an output from each of the plurality of sensors, and interpreting the output of each of the plurality of sensors to determine a characteristic of a surface in contact with the cover.
  • the cover is sulcate. In another embodiment, the cover comprises silicone rubber. The cover may be flat.
  • providing the plurality of sensors comprises providing four sensors. Each sensor may be configured to measure force in three dimensions.
  • the method may further comprise utilizing learning approaches to improve interpreting the output of each of the plurality of sensors.
  • the characteristic is the curvature of the surface. In another embodiment, the characteristic is the edge of the surface.
  • anatomical member means an object or device resembling a portion of human or animal anatomy including, but not limited to, prosthetics, robotics, and other humanoid objects or devices.
  • Coupled is defined as connected, although not necessarily directly, and not necessarily mechanically.
  • a step of a method or an element of a device that "comprises,” “has,” “includes” or “contains” one or more features possesses those one or more features, but is not limited to possessing only those one or more features.
  • a device or structure that is configured in a certain way is configured in at least that way, but may also be configured in ways that are not listed.
  • FIG. 1 is a flow chart illustrating an exemplary process for obtaining an aesthetic prosthesis from a service provider according to one embodiment.
  • FIG. 2 is a recreation illustrating an amputated finger recreated from a CT scan according to one embodiment.
  • FIG. 3 is a design illustrating a slip-on aesthetic prosthesis according to one embodiment.
  • FIG. 4 is a block diagram illustrating a mold for an aesthetic prosthesis according to one embodiment.
  • FIG. 5 is a recreation illustrating a finger according to one embodiment.
  • FIG. 6 is a graph illustrating the force-time results obtained from a TPS when a subject was holding a cup according to one embodiment.
  • FIG. 7 is a graph illustrating the force-time results obtained from a TPS when a subject was lifting a mobile phone according to one embodiment.
  • FIG. 8 is a graph illustrating the force time results obtained from a TPS when a subject lifting a pen according to one embodiment.
  • FIG. 9 is a design illustrating a slip-on aesthetic prosthesis with mechanical parts according to one embodiment.
  • FIG. 10 is an illustration of a static and dynamic model aesthetic prosthesis according to one embodiment.
  • FIG. 11 is a block diagram illustrating a system for controlling a dynamic prosthetic according to one embodiment.
  • FIG. 12 is a block diagram illustrating an exemplary temperature monitoring and control system for a prosthetic replacement according to one embodiment.
  • FIG. 13 is a cross-sectional view illustrating an exemplary prosthetic finger with an enclosed heating element according to one embodiment.
  • FIG. 14 is a top view illustrating an exemplary heating element in a prosthetic finger according to one embodiment.
  • FIG. 15 is a front cross-sectional view illustrating an exemplary prosthetic finger with a heating element according to one embodiment.
  • FIG. 16 is a side view illustrating an exemplary resistive heating element for use in a prosthetic device according to one embodiment.
  • FIG. 17 is a top view illustrating an exemplary resistive heating element for use in a prosthetic device according to one embodiment.
  • FIG. 18 is a side cross-sectional view of an exemplary remote dynamic calibration unit for use in a prosthetic device according to one embodiment.
  • FIG. 19 is a block diagram illustrating an exemplary wearable strap for a prosthetic device according to one embodiment.
  • FIG. 20 is a front view illustrating an exemplary temperature sensing element for a prosthetic device according to one embodiment.
  • FIG.21 is a block diagram illustrating an exemplary circuitry for temperature sensing and heat control according to one embodiment.
  • FIG. 22 is a flow chart illustrating a method for regulating a temperature of a prosthetic replacement according to one embodiment.
  • FIG. 23 is a flow chart illustrating a method for regulating a temperature of a prosthetic replacement according to one embodiment.
  • FIG. 24 is a schematic block diagram of a 2x2 sensor.
  • FIG. 25A is a side view of a sulcate skin cover.
  • FIG. 25B is a side view of a flat skin cover.
  • FIG. 25C is a perspective view of a sulcate skin cover.
  • FIG. 25D is a perspective view of a flat skin cover
  • FIG.26A is a perspective view of an experimental object with flat surface measuring 15x5 mm 2 .
  • FIG.26B is a perspective view of an experimental object with sharp edge measuring 5 mm in length.
  • FIG.26C is a perspective view of an experimental object with convex curved surface with a curvature of 0.4 mm "1 .
  • FIG. 27A is a schematic diagram of a flat surface being applied to a sulcate skin cover.
  • FIG. 27B is a schematic diagram of a curved surface being applied to a sulcate skin cover.
  • FIG. 28 shows sample runs of the experiment for sulcate and flat skin covers.
  • FIG. 29A shows force resultants collected from four sensors on the tactile sensor array with flat skin cover.
  • FIG.29B shows force resultants collected from four sensors on the tactile sensor array with ridged skin cover.
  • FIG. 30 shows a comparison of various machine learning algorithms.
  • the light gray bars represent the maximum value of algorithms' accuracy rates with flat skin cover and the dark gray shows the maximum accuracy rate for sulcate one.
  • FIG. 31 shows a comparison of the actual surface of objects and the classified surface results.
  • the top graph corresponds to the samples of the flat surface (samples 1-40), the middle graph shows the samples of the object with an edge (samples 41-80), and the bottom graph displays the samples of the curved surface (samples 81-120).
  • prostheses For simplification of the present description, many of the embodiments described include prostheses. Although the present embodiments are highly valuable for the design and manufacture of prosthesis, these embodiments may also be used for the design and manufacture of other anatomical members, such as robotic objects having human or animal form, or other humanoid objects, devices, or apparatuses. One of ordinary skill in the art will recognize a variety of applications to which the present embodiments may be suitably adapted.
  • aesthetic prostheses may be obtained through an online process starting from taking the computed tomography (CT) scan from a customer to shipping back the finished prosthetic product back to the customer.
  • FIG. 1 is a flow chart illustrating an exemplary process for obtaining an aesthetic prosthesis from a service provider according to one embodiment.
  • a customer who may be an amputee visits a hospital or clinical lab and obtains a CT scan of a location of the amputation and a similar area of the body not amputated. For example, if an amputee has a right ring finger amputated above the proximal phalanx, CT scans of both of the patient's hands are obtained. Additionally, the patient may photograph their hand.
  • the picture information may be used to match the color of the prosthesis to match the pigmentation of the patient's hand.
  • additional information or scan technologies may be used such as, for example, magnetic resonance imaging (MRI).
  • MRI magnetic resonance imaging
  • the customer logs on to a website and completes an online form, including selection of a static or a dynamic prosthetic, and uploads the CT scan files. If the patient photographed their hand for pigmentation, the patient may also upload the photograph.
  • the service provider receives the CT scan, photographs, and other information from the customer. For example, additional information may be collected on forms such as personal information and/or payment and insurance information.
  • the received information may be processed and modified.
  • the processed information includes bone position and the size and texture of the finger.
  • the processing may be formed with suitable image processing software.
  • the extracted information may be obtained from a CT scan of the finger belonging to a hand of the customer that was not amputated. This data may be processed to provide a mirror image so as to recreate the amputated finger.
  • Other information that may be extracted from the received information may be bone structure, bone density, and/or skin density.
  • the service provider decides to use a dynamic or a static model for the aesthetic prosthesis.
  • the service provider decides on a dynamic or static model based, in part, on input from the user at block 104.
  • the service provider continues to block 108, to extract information from the uploaded CT scan and constructs a mold.
  • the mold is formed using additive manufacturing techniques or similar techniques.
  • a bone model for the aesthetic prosthesis is formed from information in the CT scan of the like appendage. For example, if an aesthetic prosthesis for a right hand ring finger is desired, a CT scan of the left hand ring finger may be used to provide information about the missing bone structure of the right hand ring finger.
  • extracted information from the CT scan files may be processed by using image processing and editing software.
  • the mold designed may have a texture of the skin on the inner walls of its groove and with the bone embedded within it and this setup is created using additive manufacturing techniques.
  • the service provider continues to block 110 to extract information from the uploaded CT scan and constructs a mold.
  • information extracted from the CT scan may be modified to accommodate motion.
  • the service provider fixes motors, sensors, and/or other actuators to the bone.
  • the sensors and actuators may be embedded onto the bone or another similar setup before it is encompassed with the skin.
  • a first material may be silicone-based and is pigmented with the skin color of the patient.
  • the silicone-based material is used to encompass the bone with skin.
  • a second material may be latex-based and is used for mounting the finger on the amputee. According to one embodiment, only one material is used in manufacturing the prosthesis at block 114.
  • a ring is added to the bonded materials package.
  • the ring may serve as an anchor for mounting the aesthetic prosthesis on the amputee.
  • the aesthetic prosthesis is shipped to the customer.
  • the finished prosthetic is shipped back to the customer in approximately a couple of days. Quality control or testing may be performed on the aesthetic prosthesis before shipping to the customer.
  • the process of FIG. 1 may be advantageous because the patient may make as few as a single trip to a clinic for the initial CT scan.
  • Other information used by the service provider to manufacture the prosthetic such as, for example, bone dimensions and bone positioning are obtained from the CT scan of the patient.
  • FIG. 2 is a recreation illustrating an amputated finger recreated from a CT scan according to one embodiment.
  • a distal phalange 212 and a medial phalange 213 of a ring finger is shown in the recreation.
  • Data for the recreation is obtained from a CT scan of the ring finger belonging to the hand of the customer that was not amputated. The data may be processed to produce a mirror image to recreate the amputated finger.
  • FIG. 3 is a design illustrating a slip-on aesthetic prosthesis according to one embodiment.
  • a finger 300 includes embedded skin 314 and bone 315 (including the distal and medial phalange).
  • the finger 300 also includes a groove for mounting on the stump 316 (attached to the proximal phalange).
  • a ring 317 may be included to anchor the prosthesis on to the stump 316.
  • Materials of the finger 300 may be bonded together with an interlocking ridge bonding structure 318.
  • the interlocking bonding structure 318 is a ridge type structure for bonding materials, which are used to manufacture the prosthesis.
  • FIG. 4 is a block diagram illustrating a mold for an aesthetic prosthesis according to one embodiment.
  • a mold 420 may be divided into two halves held together using screws 425.
  • the pin 422 holds a bone 430 of the finger in place, and screws 421 prevent the bone 430 from moving.
  • data for the bone position may be extracted from a CT scan file.
  • Data for constructing a cavity or groove in the mold 420 for materials may also be extracted from the CT scan.
  • the bone 430 and filler 424 are injected into the mold 420 and bond at a boundary zone.
  • a finger cavity for the stump includes a filler 424 in the mold 420.
  • the filler 424 may be very similar to the stump of the customer and obtained from data in the CT scan.
  • a groove 423 and a groove 426 may be empty voids for filling by both a first material and a second material, respectively during the manufacturing process.
  • a service provider may select a number of and locations for injection points. According to one embodiment, when only one material is used only one injection point is provided. According to one embodiment, at the separation point of the materials two injected materials are bonding ridges 429 in the mold 420, which help in bonding aesthetic and mounting material together.
  • FIG. 5 is a recreation illustrating a finger according to one embodiment.
  • a finger 500 includes a distal phalanx 530 and a medial phalanx 531 embedded within the finger 500.
  • a material 532 may be coated with a latex-based material 533 or similar material. The material 533 improves the stability of the finger 500. Both materials 532, 533 are bonded together at a bonding layer 534 indicated by the dotted line 534.
  • the setup of FIG. 5 may be mounted on the stump 535 similar to how a glove is worn on a hand.
  • the finger 500 may include elastic rubber to mount on the stump 535.
  • the finger 500 may be placed on the stump 535 by vacuum suction.
  • a dynamic model for an aesthetic prosthesis may include motors, actuators, and sensors on the prosthesis to allow the prosthesis to act life-like.
  • An understanding of the motion of a human hand allows for construction of a controller for the motors, actuators, and sensors to create a life-like appearance for an aesthetic prosthesis. Measurements of the motion of a human hand are performed using a tactile pressure sensor (TPS) fingertip sensor for measuring the contact forces between finger tips and different surfaces.
  • TPS tactile pressure sensor
  • FIG.6 is a graph illustrating the force- time results obtained from a TPS when a subject was holding a cup according to one embodiment.
  • FIG. 7 is a graph illustrating the force-time results obtained from a TPS when a subject was lifting a mobile phone according to one embodiment.
  • FIG. 8 is a graph illustrating the force time results obtained from a TPS when a subject lifting a pen according to one embodiment.
  • the graphs of FIGs. 6, 7 and 8 demonstrate for all the activities performed, there was co-ordination between the ring and pinkie fingers, although for many activities, the middle finger also coordinated alongside the ring and pinkie finger.
  • the forces exerted by the pinkie and ring fingers were of similar magnitude as compared to that of the middle finger. Thus, although these three fingers were well correlated there was a greater co-ordination between ring and pinkie finger.
  • FIG. 9 is a design illustrating a slip-on aesthetic prosthesis with mechanical parts according to one embodiment.
  • the finger 900 is generated from information in the CT scan and is modified to include mechanical parts.
  • a ring base 940 anchors the finger 900 to the amputee's stump (not shown) and is mechanically attached to an intermediate phalanx 935 using a support structure 938.
  • the setup has two degrees of freedom (DOF): around a joint 936 and around a joint 937.
  • the joint 937 may be created by attaching the support structure 938 to the intermediate phalanx 935.
  • the finger 900 also includes a control circuit 939.
  • FIG. 10 is an illustration of a static and dynamic model aesthetic prosthesis according to one embodiment.
  • a person using the static prosthetic 1043 has a disadvantage as the static prosthetic does not follow the motion of the other fingers on the hand while writing with a pen.
  • An accelerometer may be embedded within a sensing ring 1041 or a sensing band 1042 and mounted on a finger, such as the pinkie finger.
  • a person using a dynamic prosthetic 1044 adjusts motion of the aesthetic prosthetic to the motion of the other fingers on the hand.
  • Sensing devices on the pinkie finger and ring finger prosthetic apparatus may be synchronized in such a way that the ring finger will always follow the pinkie finger.
  • behavior for the aesthetic prosthesis is designed to mimic the human action measured corresponding activities measured in FIGs.6, 7, and 8.
  • Power for the mechanical devices in the dynamic prosthetic may be powered wirelessly by a watch, or similar device, in proximity of the prosthetic.
  • the watch or another device may be powered mechanically by human motion or a battery.
  • FIG. 11 is a block diagram illustrating a system for controlling a dynamic prosthetic according to one embodiment.
  • a microcontroller 1102 is coupled to a motor 1104 in the dynamic prosthetic and a sensor 1106 for measuring motion of the dynamic prosthetic.
  • the microcontroller 1102 may output commands to the motor 1104.
  • the sensor 1106 may measure the output of the motor 1104 and provide input to the microcontroller 1102 to produce a feedback loop.
  • the microcontroller 1102 may receive input from a sensing device 1108 and a sensing device 1110 through a wired coupling or a wireless connection.
  • the sensing devices 1108, 1110 may be, for example, mounted on a ring finger and a pinkie finger of a hand, respectively.
  • a controller or power source may be located in a wrist watch 1112.
  • the wrist watch 1112 may couple to the microcontroller 1102 through a wire or wirelessly.
  • other actuators may be substituted for the motor 1104.
  • a prosthetic manufactured as described above may be manufacturing in one location and shipped around the world allowing prosthetics to become available world-wide. Additionally, the method may be used to develop robotic hands. Further, the manufacturing process may be used to create artificial hands with or without motion for the entertainment industry. For example, hands may be manufactured for the film industry, amusement parks, festivals, or Halloween decoration.
  • the skin temperature of the user may be mimicked on his prosthetic device.
  • a temperature monitoring and control system may be placed remote from the prosthetic device on a wearable strap to mimic human skin temperature characteristics and use the control information from this remote system to drive a heating element embedded in the prosthetic device to a controlled temperature similar to human skin.
  • the heating device may include a flexible heating element.
  • the prosthetic device includes a controller that helps mimic human skin temperature characteristics by dynamically detennining and regulating a temperature of the prosthetic device with varying room temperature.
  • a portion of the prosthetic device may be wearable on a wrist band/watch.
  • a system for heating a prosthetic device to substantially mimic human skin temperature may include a heating element, a calibration unit, and a temperature control unit.
  • FIG. 12 is a block diagram illustrating an exemplary temperature monitoring and control system for a prosthetic replacement according to one embodiment.
  • a system for regulating temperature may include a temperature control unit 100, a temperature sensor 110, a power supply 130, and a calibration unit 120.
  • the temperature control unit 100 includes a microcontroller.
  • Wires 132 couple the temperature control unit 100 to a heating element 160 in a prosthetic replacement 140.
  • the power supply 130 may be a battery.
  • the prosthetic replacement 140 may be, for example, an arm, a hand, a finger, a toe, a foot, or a leg. Additionally, the system for heating a prosthetic device may be used for internal skin surfaces and membranes, such as orifices, as well as external skin surfaces.
  • FIG. 13 is a cross-sectional view illustrating an exemplary prosthetic finger with an enclosed heating element according to one embodiment.
  • FIG. 14 is a top view illustrating an exemplary heating element in a prosthetic finger according to one embodiment.
  • FIG. 15 is a front cross-sectional view illustrating an exemplary prosthetic finger with a heating element according to one embodiment.
  • a heating element 160 may be embedded in a prosthetic replacement 140. The heating element 160 may be embedded in the prosthetic replacement 140 and drive heat to the surface of the prosthetic replacement.
  • the heating element 160 may be a resistive heating element.
  • FIG. 16 is a side view illustrating an exemplary resistive heating element for use in a prosthetic device according to one embodiment.
  • FIG. 17 is a top view illustrating an exemplary resistive heating element for use in a prosthetic device according to one embodiment.
  • the heating element 160 may be driven by the temperature control unit 100 by coupling wires 122 to the wires 132.
  • a bone structure of the prosthetic replacement 140 may provide supporting structure for the heating element 160.
  • the temperature calibration unit 120 of FIG. 12 may provide temperature data to the temperature control unit 100 for selecting a temperature to warm the prosthetic replacement 140.
  • the temperature calibration unit 120 measures the temperature on the surface of a sample skin material of known thickness, which is read and stored in the temperature control unit 100, and adjusts the power delivered to the prosthetic replacement 140 to mimic human skin temperature characteristic.
  • FIG. 18 is a side cross-sectional view of an exemplary remote dynamic calibration unit for use in a prosthetic device according to one embodiment.
  • a remote dynamic calibration unit 700 may include a sample skin material 702 of known thickness placed between a heating element 706 and a temperature sensor 704. The calibration unit 700 may apply heat to the sample skin 702 and measure the resulting temperature of the sample skin 702 with the temperature sensor 704. If the heating element 706 is a resistive heating element, the calibration unit 700 may apply a series of currents to the sample skin 702 and measure the temperature of the sample skin 702 with the temperature sensor 704 for each applied current. The resulting table of current and temperature values may be used by the temperature control unit 100 for applying heat to the prosthetic replacement 140.
  • the temperature control unit 100 may be attached to a strap 150 such as a watch or bracelet.
  • FIG. 19 is a block diagram illustrating an exemplary wearable strap for a prosthetic device according to one embodiment.
  • a strap 150 may include the temperature control unit 100, the temperature sensor 110, the calibration unit 120, and the power supply 130.
  • the temperature control unit may be built on a flexible printed circuit board (PCB).
  • FIG. 20 is a front view illustrating an exemplary temperature sensing element for a prosthetic device according to one embodiment.
  • the temperature sensor 110 may be embedded in the strap 150 to provide measurements of a human's actual skin temperature. For example, if the strap 150 is worn around a user's body and coupled to the prosthetic replacement 140, the embedded temperature sensor 110 may provide measurements of the user' s skin temperature to the temperature control unit 100. The temperature control unit 100 may use the measured skin temperature to determine, in part, the temperature of the prosthetic replacement 140.
  • the prosthesis temperature may also be regulated by using a temperature sensor to measure the ambient temperature and drive a heating element based on a lookup table.
  • the look up table may be acquired by prior measurement of human skin temperature profiles at several ambient temperatures. Temperature profiles for different persons may be measured and stored as a lookup table.
  • the temperature control unit 100 may use the measured ambient temperature and the lookup table corresponding to the user to deliver power to the heating element. According to one embodiment, power is delivered by estimating the duty cycle for the pulse width modulator (PWM). Therefore, the prosthetic replacement is elevated to a desired human skin temperature.
  • PWM pulse width modulator
  • FIG.21 is a block diagram illustrating an exemplary circuitry for temperature sensing and heat control according to one embodiment.
  • the heating element 160 may be driven by a power field effect transistor (FET) 950, and the heating element 706 may be driven by a power FET 960.
  • Power FETS may have a very low on resistance to reduce power loss in the FET thereby improving the efficiency of the heating system.
  • the power FETs 950, 960 may be controlled by a pulse width modulator (PWM) 940.
  • PWM pulse width modulator
  • the modulator 940 may be controlled to vary pulse width during run time based, in part, on calibration data from the calibration unit 120.
  • a PWM-based power controller circuit receives a temperature from the temperature sensor 704 and from the temperature sensor 110 at a two-channel analog to digital converter 970.
  • the temperatures may be received from the sensors 110, 704 as voltages proportional to the temperatures.
  • the sensed voltage serves as a root for finding the calibration data based on a formula obtained from human skin temperature and prosthetic skin material characteristics.
  • the prosthetic replacement 140 may be part of a teaching dummy.
  • the teaching dummy may be used to teach medical students to treat and care for the patients.
  • intelligent mannequins for use as automated nurses may be fitted with a heating control system to provide more humanistic appeal using the method described.
  • the prosthetic replacement 140 may be integrated into a sex doll.
  • FIG. 22 is a flow chart illustrating a method for regulating a temperature of a prosthetic replacement according to one embodiment.
  • temperatures of a human skin is measured and a sample skin material is measured.
  • power to a heating element in the prosthetic replacement is regulated to elevate the temperature of the prosthetic replacement to a temperature range approximately equal to the measured human skin temperature.
  • FIG. 23 is a flow chart illustrating a method for regulating a temperature of a prosthetic replacement according to one embodiment.
  • the ambient temperature is measured.
  • power is regulated to a heating element in the prosthetic replacement based, in part, on a lookup table to elevate the temperature of the prosthetic replacement to a desired temperature range.
  • tactile sense duplication may be offered as an optional feature of anatomical members formed according to the embodiments described above.
  • a biologically inspired approach may provide robots or paralyzed humans with the perception of local touch on their fingers which mainly concerns the recognition of objects through their local shapes such as curvatures, angles, and edges.
  • the tactile perception may be signified with a sulcate skin cover which simulates human skin with fingerprints.
  • local shapes of objects' surfaces which mainly consist of surface curvatures, can be learned and recognized through touch by robotic/prosthetic hands.
  • This invention can be used preferably with 3-dimensional tactile sensors, i.e. the sensors that can provide three force vectors comprising one normal, two tangential, and further, one additional force vector that is the total of the former three loads.
  • 1 -dimensional or 2 -dimensional tactile sensors may be used.
  • a 2x2 sensor may be used, which can detect and measure the pressure value when it comes into contact with objects.
  • This sensor pad in particular consists of four small sensors placed on the four sides of a square.
  • a commercially available sensors may be used.
  • three force components may be generated which are measured along the three spatial axes of x, y, and z.
  • the corresponding resultant data of the 3D force may then be able to be exported for further use.
  • the resultant 3D forces which the sensors sense at different locations on the surface may be different owing to the curvature of the surface. Therefore, the resultant 3D forces may reflect the local shape correctly.
  • the statistical features of the resultant 3D force data may be extracted while noise may be removed to provide an improved measurement.
  • various learning approaches for example classifiers including Neural Network, naive Bayes, and various Kernel functions with different corresponding parameters for Support Vector Machine (S VM), may be executed to construct connections among the data so as to achieve the desirable performance of the classifiers.
  • S VM Support Vector Machine
  • the resultant 3D force is the only requisite to achieve the local shape recognition function.
  • two skin covers each having four hollows that match the four bumps of tactile sensors on the sensor pad may be used.
  • One may be a sulcate skin cover which simulates the human fingerprints and the other may be a flat one.
  • the skin covers may be elastic and not sticky and not slippery, and 2) the skin covers may be placed exactly on top of the sensor pad.
  • three basic curvatures may be discriminated.
  • a sensor may be implemented to collect sensory data from objects' surfaces.
  • FIGs. 25A and C show side and perspective views of one embodiment of a sulcate skin cover that may simulate the fingerprints' role and may be placed on the sensors. This cover with its ridges may perform spectral selection and amplification of the tactile information about physical properties of an object.
  • a flat skin cover with its structure shown in FIGs. 25B and D may be used.
  • FIG. 26A-C show three objects having three different shapes.
  • the three different objects have a front shape that is: flat (FIG. 26A), edged (FIG. 26B), and convex curved with a curvature of 0.4 mm “1 (FIG. 26C). These objects may be used to show the force profile on a pressure sensor. For each curvature 40 samples of force data may be collected.
  • objects may be applied vertically on the skin covers and to the center of the sensors. It should be noted that since some embodiments are targeted for local shape recognition, in some cases the size of objects should not be much larger than the sensor pad size; otherwise, as the sensors are immobilized with regard to the objects, the curved one in contact with the sensors will be felt as a flat surface.
  • FIG 28 shows three sets of raw experimental data for each of the three objects.
  • the graphs are shown for both skin covers.
  • the experimental data for each skin cover with each of the objects is collected from different runs of the experiments carried out in the same condition.
  • Each graph presents four responses corresponding to the resultant forces from the four sensors of the tactile sensor array.
  • a signal processing method may be used to process the measurements from the sensors. The processing may reduce noise which can degrade the quality of the desired measurement.
  • a Finite Impulse Response (FIR) filter may be used.
  • FIG.29A shows examples of the filtered 3D force resultants collected from four sensors on the tactile sensor array with flat skin cover.
  • FIG. 29B shows the examples of the filtered 3D force resultants collected from four sensors on the tactile sensor array with sulcate skin cover.
  • the sensory data (the resultant 3D force filtered or not filtered by the FIR) may be decomposed into its constructing features.
  • the sensory data may be decomposed into statistical features such as mean, standard deviation, and the maximum value of the force signals.
  • information from the sensors may then be employed to construct connections among stored data through training various classifiers using samples. For example, 30 samples of each curvature may be used while the other 10 samples of each class may be held for validation.
  • Neural Network, naive Bayes, and various Kernel functions with different corresponding parameters for Support Vector Machine (SVM) can be used to achieve improved performance on the validation dataset for both flat and sulcate skin covers.
  • Table 1 shows the accuracy rate results of different classifying approaches for testing the above-mentioned three different objects having three different shapes utilizing a flat skin cover.
  • Table 2 shows the accuracy rate results of different classifying approaches for testing the above- mentioned three different objects having three different shapes utilizing a sulcate skin cover.
  • FIG. 30 shows a comparison of the maximum accuracy rates for various recognition algorithms for 120 data samples collected.
  • SVM with a radial basis function Kernel may result in the best recognition of objects' local shape.
  • a remarkable improvement may be noticed in performances by employing sulcate skin cover rather than a flat one.
  • the improvement in performance may be due to the fact that a sulcate skin cover simulates fingerprints, which may boost the detailed force information received from an object's shape.
  • FIG. 31 shows the results of an experiment that sought to determine the accuracy of measurements of object with different shapes.
  • the first 40 samples are flat objects
  • the second 40 are edged objects
  • the third 40 are curved objects—the experimental results of an embodiment of the invention resulted in an accuracy of 97.5% recognition rate.
  • algorithms, or artificial intelligence may be used to "learn” from previous measurements. Applying trained models of known objects to measurements of unknown objects may allow the system to deduce the shape of the unknown objects.
  • the proposed apparatus and methods may be used in robotic and/or prosthetic hands by providing local tactile sense. Some advantages include a fast and simple algorithm as well as humanlike skin cover with fingerprints which may play an essential role for both sociable robots and amputees to be embraced in social life.
  • the proposed apparatus and methods may be used in various prosthetic replacements and robotic limbs.
  • Support Vector Machine S VM
  • Neural Networks N
  • Naive Bayes which are pattern recognition methods, are implemented to discriminate three different curvatures of objects using the sensory data collected through experiments. These experiments have been carried out by a commercially available 2 ⁇ 2 sensor pad (FIG. 24).
  • a sulcate skin cover FIGG. 25, A and C
  • FIG. 25A To humanize the tactile sensors, a sulcate skin cover (FIG. 25, A and C) which simulates the fingerprints' role is placed on the top of the sensors. It performs spectral selection and amplification of the tactile information about physical properties of an object which is verified by repeating the same set of experiments for flat skin cover (FIG. 25, B and D). Then, three different objects with flat (FIG. 26A), edged (FIG.
  • the sensory data were decomposed into their constructing features.
  • This step is called feature extraction which is to select the optimum representations of a given dataset that contains the most useful information of the dataset and results in a desirable performance of the classifier. These features should be chosen carefully such that for each class they gather the most salient and distinguishable information. Due to the huge influence of feature extraction on classification results, in this study, first the dataset for each class were sketched to provide a good understanding of their differences. Based on the observations, we selected the statistical features such as mean, standard deviation, and the maximum value of the 3D resultant force signals.
  • each collected data included four subsets of data from the four sensors of the pad, and each of these four subsets corresponded to the total force signal of the normal and tangential forces. Therefore, an overall twelve features (4 subsets x 3 statistical features) were extracted and then stored from each collected data.

Abstract

Apparatuses, systems, and methods for prosthetic replacement manufacturing, temperature regulation and tactile sense duplication are disclosed. An online prosthetic service allows a customer to purchase a prosthetic device online. A mold is constructed by using data extracted from the CT scans uploaded by the customer online and a prosthetic is made by injecting materials into the mold. A prosthetic replacement may be modified to mimic human skin temperature characteristics. A heating element is embedded in a prosthetic. Calibration data may be stored with the temperature controller to allow dynamic compensation of the temperature of the prosthetic replacement to match environmental conditions. An apparatus for tactile sense duplication may include a plurality of sensors coupled with a cover which may be configured to increase the sensitivity of the sensors. A measurement module may be configured to receive information from the sensors and determine a characteristic of a surface touching the cover.

Description

APPARATUSES, SYSTEMS, AND METHODS FOR PROSTHETIC REPLACEMENT MANUFACTURING, TEMPERATURE REGULATION AND TACTILE SENSE DUPLICATION
BACKGROUND OF THE INVENTION FIELD OF THE INVENTION
[0001] This invention relates to prosthetics and more particularly relates to apparatuses, systems, and methods for prosthetic replacement manufacturing, temperature regulation and tactile sense duplication.
DESCRIPTION OF THE RELATED ART
[0002] Limb amputation is an experience linked with grief, depression, anxiety, loss of self- esteem and social isolation. Amputation may be performed for medical reasons or after motor vehicle accidents, industrial and household accidents. Aesthetic prostheses significantly assist patients coping with the traumatic experience resulting from amputation. The use of certain prostheses, such as prosthetic hands, are difficult because the choices of materials available rarely allows interaction with others. That is, aside from functional limitations, the loss of a finger implies negative consequences on the person and to those around the person. For example, self- image, social, physical and practical concerns are key factors in the adjustment process for an amputee. The ability to conceal use of aesthetic prostheses allows some amputees to ward off social stigmatization, which results in better integration into society and reduction of emotional problems.
[0003] One shortcoming in existing prosthetic solutions is the process involved in obtaining an aesthetic prosthesis. For example, numerous doctors' appointments and fitting appointments decreases access to aesthetic prostheses for many amputees. Additionally, the aesthetic prostheses do not have a similar structure as the limb being replaced. For example, the bone structure in a human hand is different from the soft silicone present in conventional aesthetic prostheses. These differences lead to discomfort for the wearer and decreases the ability for an amputee to integrate into society. Thus, there is a need for rapid manufacturing aesthetic prostheses and improving access to aesthetic prostheses for amputees.
[0004] While easy access to aesthetic prostheses provide a solution for amputees to ward off social stigmatization, temperature regulation and tactile sense duplication can help amputees further in social interactions through touch sensation.
[0005] Everyday human activities are characterized by numerous touch-related experiences. Touching and being touched is an important social aspect for human beings. Touch related activities help human beings to communicate thoughts and emotions through social behavior. Humans who accidentally lose their body parts, such as arms and fingers, are limited in their expression and reception of touch and related experiences. Therefore, there is a need for prosthetic replacements to provide or receive touch sensation. Furthermore, the skin warmth when touched by another human being may be important to communicate certain thoughts and emotions. Therefore, there is a need to mimic the human body's skin temperature to bridge the differences between a human body part and a prosthetic replacement.
[0006] Tactile sensation is another fundamental human sense. Environmental knowledge may be obtained and motions may be communicated through the sense of touch. For example, a person can tell the positions of the keys on a keyboard through tactile sensation. In another example, one may also tell the emotions of a person from tactile sensation of face muscles of that person. Therefore, there is a need for prosthetic replacements to be able to duplicate tactile senses and send the duplicated senses to the amputees wearing the prosthetic replacements.
SUMMARY OF THE INVENTION
[0007] Embodiments of apparatuses, systems, and methods for manufacturing of anatomical members including temperature regulation and tactile sense duplication are presented. An embodiment of a method for manufacturing an anatomical member may include receiving electronic information defining one or more anatomical characteristics of a customer. Additionally, the method may include processing the information to generate a model of the anatomical member. In a further embodiment, the method may include forming the anatomical member from the model.
[0008] In one embodiment, the anatomical unit is a prosthesis. In some embodiments, the anatomical unit is robotic. In a further embodiment, the method may include providing one or more rigid structures corresponding to anatomical features of the customer defined in the electronic information. The method may also include integrating the one or more anatomical features with the anatomical member.
[0009] In a further embodiment, the method may include measuring temperatures of a human skin and a sample skin material, and regulating power to a heating element in the anatomical member to elevate the temperature of the prosthetic replacement to a temperature within a predetermined range of the measured human skin temperature. In such an embodiment, the method may also include providing a temperature regulation unit for regulating the temperature of a surface of the anatomical member.
[0010] In some embodiments, providing a temperature regulation unit further may include providing a temperature control unit, providing a temperature calibration unit configured to be coupled to the temperature control unit, and providing a power supply configured to be coupled to the temperature control unit, in which the temperature control unit regulates an output of the power supply to regulate the temperature of the prosthetic replacement.
[0011] In one embodiment, the method may include providing a plurality of sensors coupled to a surface of the anatomical member, where each sensor configured to measure force in at least one direction, providing a cover coupled to the plurality of sensors, measuring an output from each of the plurality of sensors, and interpreting the output of each of the plurality of sensors to determine a characteristic of a surface in contact with the cover.
[0012] An embodiment of a method for manufacturing an anatomical member may include receiving information from a customer electronically. Such an embodiment may also include processing the information according to at least one of a static or dynamic model. The method may also include forming a mold for the prosthetic according to the model. Additionally, the method may include filling the mold to form the anatomical member. In one embodiment, the anatomical member is a prosthesis.
[0013] In a further embodiment, the method may include receiving the information comprises receiving at least one of a computed tomography (CT) scan, a photograph, personal information, payment information, and insurance information.
[0014] In certain embodiments, processing the information may include obtaining data to produce a mirror image of a remaining appendage of the customer. Additionally, processing the information may include extracting information about at least one of a bone, a bone density, a bone position, and a bone structure. Processing the information may further include extracting information about at least one of a body part, a size of a body part, a skin texture of a body part, and a skin density of a body part of the customer. Additionally, processing the information comprises designing at least one of a motor, sensor, and actuator to attach to the anatomical member.
[0015] In a further embodiment, the method may include attaching a ring to the anatomical member, in which the ring anchors the anatomical member to the customer. In still further embodiments, the method may include receiving the information comprises receiving the information via the Internet. Additionally, the method may include shipping the anatomical member to the customer. In a certain embodiment, the anatomical member is a prosthetic finger.
[0016] Embodiments of a mold for an anatomical member are also presented. In one embodiment, the mold includes a first half and a second half coupled together by screws, a void between the first half and the second half corresponding to the shape of the anatomical member as defined by a model generated from electronic information provided by a customer, a pin for affixing a position of a bone member in the void, and injection holes for injecting material into the void. In a further embodiment, the void comprises a location for at least one of a motor, an actuator, and a sensor.
[0017] In one embodiment of the mold, the anatomical member is a prosthesis. In a further embodiment, the anatomical member is a finger. In still a further embodiment, the mold comprises an interlocking ridged bonding structure.
[0018] Embodiments of an apparatus for regulating a temperature of a prosthetic replacement are also presented. In one embodiment, the apparatus includes a temperature control unit. The apparatus may also include a temperature calibration unit coupled to the temperature control unit. Additionally, the apparatus may include a power supply coupled to the temperature control unit, in which the temperature control unit regulates an output of the power supply to regulate the temperature of the prosthetic replacement.
[0019] In a further embodiment, the apparatus includes a temperature sensor coupled to the temperature control unit. In a particular embodiment, the temperature control unit comprises: a pulse width modulator (PWM) coupled to a power field effect transistor (FET), an analog-to- digital (ADC) converter coupled to the temperature sensor, and a programmable logic device coupled to the PWM and coupled to the ADC, in which the programmable logic device controls the PWM based, in part, on an output of the ADC. In one embodiment, the temperature control unit may be mounted on a flexible printed circuit board (PCB).
[0020] In a further embodiment, the apparatus may include a heating element coupled to the temperature control unit, in which the temperature control unit elevates the temperature of the prosthetic replacement by applying power to the heating element.
[0021] In one embodiment, the temperature control unit, the temperature calibration unit, and the power supply may be attached to at least one of a wearable strap, bracelet, and watch. In a further embodiment, the temperature control unit may regulate the temperature of the prosthetic replacement to substantially mimic a human skin temperature. In one embodiment, the prosthetic replacement is at least one of an arm, a hand, a finger, a toe, a foot, and a leg.
[0022] In a further embodiment, the temperature calibration unit may include a skin material sample substantially similar to a material of the prosthetic replacement, a temperature sensor in proximity of the sample skin material on a first side of the sample skin material, and a heating element in proximity of the sample skin material on a second side opposite the first side of the sample skin material.
[0023] Embodiments of a method for regulating a temperature of a prosthetic replacement is also presented. In one embodiment, the method includes measuring temperatures of a human skin and a sample skin material, and regulating power to a heating element in the prosthetic replacement to elevate the temperature of the prosthetic replacement to a temperature range approximately equal to the measured human skin temperature. In one embodiment, measuring the human skin temperature comprises measuring the human skin temperature with a temperature sensor embedded in a strap.
[0024] In a further embodiment, the method may also include applying a power level to a sample heating element in proximity to the sample skin material, measuring a calibration temperature of the sample skin material after applying the power level to the sample heating element, and determining a power output to the heating element based, in part, on the calibration temperature of the sample skin material.
[0025] In a further embodiment, measuring the temperature of the human skin comprises measuring the temperature of at least one of an arm, a hand, a finger, a foot, a toe, and a leg.
[0026] Embodiments of a method for regulating a temperature of a prosthetic replacement are also presented. In one embodiment, the method may also include measuring the ambient temperature, and regulating power to a heating element in the prosthetic replacement based, in part, on a lookup table to elevate the temperature of the prosthetic replacement to a desired temperature range. [0027] In one embodiment, the method may also include measuring human skin temperature profiles at various ambient temperatures to form the lookup table. Also, the method may include storing the lookup table in a temperature control unit. In one embodiment, regulating power to the heating element comprises estimating a duty cycle for a pulse width modulator.
[0028] In one embodiment, the prosthetic replacement is at least one of an arm, a hand, a finger, a foot, a toe, and a leg.
[0029] Embodiments of an apparatus for measuring the contours of a surface are also presented. In one embodiment, the apparatus may include a plurality of sensors, each sensor configured to measure force in at least one direction, a cover coupled to the plurality of sensors, and a measurement module configured to receive information from the plurality of sensors and determine a characteristic of a surface touching the cover. In one embodiment, the cover is sulcate. In another embodiment, the cover comprises silicone rubber. In certain embodiments, the cover may be flat.
[0030] In one embodiment, the plurality of sensors comprises four sensors. In such an embodiment, each sensor may be configured to measure force in three dimensions. For example, the characteristic may be the curvature of the surface. In another embodiment, the characteristic is the edge of the surface.
[0031] Embodiments of a method for measuring the contours of a surface are presented. In one embodiment, the method includes providing a plurality of sensors, where each sensor configured to measure force in at least one direction, providing a cover coupled to the plurality of sensors, measuring an output from each of the plurality of sensors, and interpreting the output of each of the plurality of sensors to determine a characteristic of a surface in contact with the cover.
[0032] In one embodiment, the cover is sulcate. In another embodiment, the cover comprises silicone rubber. The cover may be flat.
[0033] In one embodiment, providing the plurality of sensors comprises providing four sensors. Each sensor may be configured to measure force in three dimensions. The method may further comprise utilizing learning approaches to improve interpreting the output of each of the plurality of sensors. In one embodiment, the characteristic is the curvature of the surface. In another embodiment, the characteristic is the edge of the surface.
[0034] As used herein, the term "anatomical member" means an object or device resembling a portion of human or animal anatomy including, but not limited to, prosthetics, robotics, and other humanoid objects or devices.
[0035] The term "coupled" is defined as connected, although not necessarily directly, and not necessarily mechanically.
[0036] The terms "a" and "an" are defined as one or more unless this disclosure explicitly requires otherwise.
[0037] The terms "comprise" (and any form of comprise, such as "comprises" and "comprising"), "have" (and any form of have, such as "has" and "having"), "include" (and any form of include, such as "includes" and "including") and "contain" (and any form of contain, such as "contains" and "containing") are open-ended linking verbs. As a result, a method or device that "comprises," "has," "includes" or "contains" one or more steps or elements possesses those one or more steps or elements, but is not limited to possessing only those one or more elements. Likewise, a step of a method or an element of a device that "comprises," "has," "includes" or "contains" one or more features possesses those one or more features, but is not limited to possessing only those one or more features. Furthermore, a device or structure that is configured in a certain way is configured in at least that way, but may also be configured in ways that are not listed.
[0038] Other features and associated advantages will become apparent with reference to the following detailed description of specific embodiments in connection with the accompanying drawings.
BRIEF DESCRIPTION OF THE DRAWINGS
[0039] The following drawings form part of the present specification and are included to further demonstrate certain aspects of the present invention. The invention may be better vmderstood by reference to one or more of these drawings in combination with the detailed description of specific embodiments presented herein.
[0040] FIG. 1 is a flow chart illustrating an exemplary process for obtaining an aesthetic prosthesis from a service provider according to one embodiment.
[0041] FIG. 2 is a recreation illustrating an amputated finger recreated from a CT scan according to one embodiment.
[0042] FIG. 3 is a design illustrating a slip-on aesthetic prosthesis according to one embodiment.
[0043] FIG. 4 is a block diagram illustrating a mold for an aesthetic prosthesis according to one embodiment.
[0044] FIG. 5 is a recreation illustrating a finger according to one embodiment.
[0045] FIG. 6 is a graph illustrating the force-time results obtained from a TPS when a subject was holding a cup according to one embodiment.
[0046] FIG. 7 is a graph illustrating the force-time results obtained from a TPS when a subject was lifting a mobile phone according to one embodiment.
[0047] FIG. 8 is a graph illustrating the force time results obtained from a TPS when a subject lifting a pen according to one embodiment.
[0048] FIG. 9 is a design illustrating a slip-on aesthetic prosthesis with mechanical parts according to one embodiment.
[0049] FIG. 10 is an illustration of a static and dynamic model aesthetic prosthesis according to one embodiment.
[0050] FIG. 11 is a block diagram illustrating a system for controlling a dynamic prosthetic according to one embodiment. [0051] FIG. 12 is a block diagram illustrating an exemplary temperature monitoring and control system for a prosthetic replacement according to one embodiment.
[0052] FIG. 13 is a cross-sectional view illustrating an exemplary prosthetic finger with an enclosed heating element according to one embodiment.
[0053] FIG. 14 is a top view illustrating an exemplary heating element in a prosthetic finger according to one embodiment.
[0054] FIG. 15 is a front cross-sectional view illustrating an exemplary prosthetic finger with a heating element according to one embodiment.
[0055] FIG. 16 is a side view illustrating an exemplary resistive heating element for use in a prosthetic device according to one embodiment.
[0056] FIG. 17 is a top view illustrating an exemplary resistive heating element for use in a prosthetic device according to one embodiment.
[0057] FIG. 18 is a side cross-sectional view of an exemplary remote dynamic calibration unit for use in a prosthetic device according to one embodiment.
[0058] FIG. 19 is a block diagram illustrating an exemplary wearable strap for a prosthetic device according to one embodiment.
[0059] FIG. 20 is a front view illustrating an exemplary temperature sensing element for a prosthetic device according to one embodiment.
[0060] FIG.21 is a block diagram illustrating an exemplary circuitry for temperature sensing and heat control according to one embodiment.
[0061] FIG. 22 is a flow chart illustrating a method for regulating a temperature of a prosthetic replacement according to one embodiment.
[0062] FIG. 23 is a flow chart illustrating a method for regulating a temperature of a prosthetic replacement according to one embodiment. [0063] FIG. 24 is a schematic block diagram of a 2x2 sensor. [0064] FIG. 25A is a side view of a sulcate skin cover. [0065] FIG. 25B is a side view of a flat skin cover. [0066] FIG. 25C is a perspective view of a sulcate skin cover. [0067] FIG. 25D is a perspective view of a flat skin cover
[0068] FIG.26A is a perspective view of an experimental object with flat surface measuring 15x5 mm2.
[0069] FIG.26B is a perspective view of an experimental object with sharp edge measuring 5 mm in length.
[0070] FIG.26C is a perspective view of an experimental object with convex curved surface with a curvature of 0.4 mm"1.
[0071] FIG. 27A is a schematic diagram of a flat surface being applied to a sulcate skin cover.
[0072] FIG. 27B is a schematic diagram of a curved surface being applied to a sulcate skin cover.
[0073] FIG. 28 shows sample runs of the experiment for sulcate and flat skin covers.
[0074] FIG. 29A shows force resultants collected from four sensors on the tactile sensor array with flat skin cover.
[0075] FIG.29B shows force resultants collected from four sensors on the tactile sensor array with ridged skin cover.
[0076] FIG. 30 shows a comparison of various machine learning algorithms. The light gray bars represent the maximum value of algorithms' accuracy rates with flat skin cover and the dark gray shows the maximum accuracy rate for sulcate one. [0077] FIG. 31 shows a comparison of the actual surface of objects and the classified surface results. The top graph corresponds to the samples of the flat surface (samples 1-40), the middle graph shows the samples of the object with an edge (samples 41-80), and the bottom graph displays the samples of the curved surface (samples 81-120).
DETAILED DESCRIPTION
[0078] Various features and advantageous details are explained more fully with reference to the nonlimiting embodiments that are illustrated in the accompanying drawings and detailed in the following description. Descriptions of well known starting materials, processing techniques, components, and equipment are omitted so as not to unnecessarily obscure the invention in detail. It should be understood, however, that the detailed description and the specific examples, while indicating embodiments of the invention, are given by way of illustration only, and not by way of limitation. Various substitutions, modifications, additions, and/or rearrangements within the spirit and/or scope of the underlying inventive concept will become apparent to those skilled in the art from this disclosure.
Prosthesis Design and Manufacturing
[0079] For simplification of the present description, many of the embodiments described include prostheses. Although the present embodiments are highly valuable for the design and manufacture of prosthesis, these embodiments may also be used for the design and manufacture of other anatomical members, such as robotic objects having human or animal form, or other humanoid objects, devices, or apparatuses. One of ordinary skill in the art will recognize a variety of applications to which the present embodiments may be suitably adapted.
[0080] According to one embodiment, aesthetic prostheses may be obtained through an online process starting from taking the computed tomography (CT) scan from a customer to shipping back the finished prosthetic product back to the customer. FIG. 1 is a flow chart illustrating an exemplary process for obtaining an aesthetic prosthesis from a service provider according to one embodiment. At block 102, a customer who may be an amputee visits a hospital or clinical lab and obtains a CT scan of a location of the amputation and a similar area of the body not amputated. For example, if an amputee has a right ring finger amputated above the proximal phalanx, CT scans of both of the patient's hands are obtained. Additionally, the patient may photograph their hand. The picture information may be used to match the color of the prosthesis to match the pigmentation of the patient's hand. According to one embodiment, additional information or scan technologies may be used such as, for example, magnetic resonance imaging (MRI). [0081] At block 104 the customer logs on to a website and completes an online form, including selection of a static or a dynamic prosthetic, and uploads the CT scan files. If the patient photographed their hand for pigmentation, the patient may also upload the photograph. The service provider receives the CT scan, photographs, and other information from the customer. For example, additional information may be collected on forms such as personal information and/or payment and insurance information.
[0082] At block 105 the received information may be processed and modified. According to one embodiment, the processed information includes bone position and the size and texture of the finger. The processing may be formed with suitable image processing software. The extracted information may be obtained from a CT scan of the finger belonging to a hand of the customer that was not amputated. This data may be processed to provide a mirror image so as to recreate the amputated finger. Other information that may be extracted from the received information may be bone structure, bone density, and/or skin density.
[0083] At block 106 the service provider decides to use a dynamic or a static model for the aesthetic prosthesis. According to one embodiment, the service provider decides on a dynamic or static model based, in part, on input from the user at block 104.
[0084] If the static model is chosen, the service provider continues to block 108, to extract information from the uploaded CT scan and constructs a mold. According to one embodiment, the mold is formed using additive manufacturing techniques or similar techniques. A bone model for the aesthetic prosthesis is formed from information in the CT scan of the like appendage. For example, if an aesthetic prosthesis for a right hand ring finger is desired, a CT scan of the left hand ring finger may be used to provide information about the missing bone structure of the right hand ring finger.
[0085] According to one embodiment, extracted information from the CT scan files may be processed by using image processing and editing software. The mold designed may have a texture of the skin on the inner walls of its groove and with the bone embedded within it and this setup is created using additive manufacturing techniques.
[0086] Alternatively, if a dynamic model is chosen, the service provider continues to block 110 to extract information from the uploaded CT scan and constructs a mold. In the dynamic model, information extracted from the CT scan may be modified to accommodate motion. Then, at block 112, the service provider fixes motors, sensors, and/or other actuators to the bone. According to one embodiment, the sensors and actuators may be embedded onto the bone or another similar setup before it is encompassed with the skin.
[0087] At block 114 if two materials are used then they are bonded together according to the mold to form the aesthetic prosthesis. According to one embodiment, two materials are used to fill the mold and form an aesthetic prosthesis. A first material may be silicone-based and is pigmented with the skin color of the patient. The silicone-based material is used to encompass the bone with skin. A second material may be latex-based and is used for mounting the finger on the amputee. According to one embodiment, only one material is used in manufacturing the prosthesis at block 114.
[0088] At block 116 a ring is added to the bonded materials package. According to one embodiment, the ring may serve as an anchor for mounting the aesthetic prosthesis on the amputee.
[0089] At block 118, the aesthetic prosthesis is shipped to the customer. According to one embodiment, the finished prosthetic is shipped back to the customer in approximately a couple of days. Quality control or testing may be performed on the aesthetic prosthesis before shipping to the customer.
[0090] The process of FIG. 1 may be advantageous because the patient may make as few as a single trip to a clinic for the initial CT scan. Other information used by the service provider to manufacture the prosthetic such as, for example, bone dimensions and bone positioning are obtained from the CT scan of the patient.
[0091] FIG. 2 is a recreation illustrating an amputated finger recreated from a CT scan according to one embodiment. A distal phalange 212 and a medial phalange 213 of a ring finger is shown in the recreation. Data for the recreation is obtained from a CT scan of the ring finger belonging to the hand of the customer that was not amputated. The data may be processed to produce a mirror image to recreate the amputated finger. [0092] FIG. 3 is a design illustrating a slip-on aesthetic prosthesis according to one embodiment. A finger 300 includes embedded skin 314 and bone 315 (including the distal and medial phalange). The finger 300 also includes a groove for mounting on the stump 316 (attached to the proximal phalange). A ring 317 may be included to anchor the prosthesis on to the stump 316. Materials of the finger 300 may be bonded together with an interlocking ridge bonding structure 318. The interlocking bonding structure 318 is a ridge type structure for bonding materials, which are used to manufacture the prosthesis.
[0093] FIG. 4 is a block diagram illustrating a mold for an aesthetic prosthesis according to one embodiment. A mold 420 may be divided into two halves held together using screws 425. The pin 422 holds a bone 430 of the finger in place, and screws 421 prevent the bone 430 from moving. According to one embodiment, data for the bone position may be extracted from a CT scan file. Data for constructing a cavity or groove in the mold 420 for materials may also be extracted from the CT scan. The bone 430 and filler 424 are injected into the mold 420 and bond at a boundary zone.
[0094] A finger cavity for the stump includes a filler 424 in the mold 420. The filler 424 may be very similar to the stump of the customer and obtained from data in the CT scan. A groove 423 and a groove 426 may be empty voids for filling by both a first material and a second material, respectively during the manufacturing process. There is a material injection point 428 for the first material and an injection point 427 for the second material so that both materials may be injected into the mold 420. A service provider may select a number of and locations for injection points. According to one embodiment, when only one material is used only one injection point is provided. According to one embodiment, at the separation point of the materials two injected materials are bonding ridges 429 in the mold 420, which help in bonding aesthetic and mounting material together.
[0095] FIG. 5 is a recreation illustrating a finger according to one embodiment. A finger 500 includes a distal phalanx 530 and a medial phalanx 531 embedded within the finger 500. A material 532 may be coated with a latex-based material 533 or similar material. The material 533 improves the stability of the finger 500. Both materials 532, 533 are bonded together at a bonding layer 534 indicated by the dotted line 534. The setup of FIG. 5 may be mounted on the stump 535 similar to how a glove is worn on a hand. For example, the finger 500 may include elastic rubber to mount on the stump 535. Alternatively, the finger 500 may be placed on the stump 535 by vacuum suction.
[0096] A dynamic model for an aesthetic prosthesis may include motors, actuators, and sensors on the prosthesis to allow the prosthesis to act life-like. An understanding of the motion of a human hand allows for construction of a controller for the motors, actuators, and sensors to create a life-like appearance for an aesthetic prosthesis. Measurements of the motion of a human hand are performed using a tactile pressure sensor (TPS) fingertip sensor for measuring the contact forces between finger tips and different surfaces. FIG.6 is a graph illustrating the force- time results obtained from a TPS when a subject was holding a cup according to one embodiment. FIG. 7 is a graph illustrating the force-time results obtained from a TPS when a subject was lifting a mobile phone according to one embodiment. FIG. 8 is a graph illustrating the force time results obtained from a TPS when a subject lifting a pen according to one embodiment. The graphs of FIGs. 6, 7 and 8 demonstrate for all the activities performed, there was co-ordination between the ring and pinkie fingers, although for many activities, the middle finger also coordinated alongside the ring and pinkie finger. The forces exerted by the pinkie and ring fingers were of similar magnitude as compared to that of the middle finger. Thus, although these three fingers were well correlated there was a greater co-ordination between ring and pinkie finger.
[0097] FIG. 9 is a design illustrating a slip-on aesthetic prosthesis with mechanical parts according to one embodiment. The finger 900 is generated from information in the CT scan and is modified to include mechanical parts. A ring base 940 anchors the finger 900 to the amputee's stump (not shown) and is mechanically attached to an intermediate phalanx 935 using a support structure 938. According to one embodiment, the setup has two degrees of freedom (DOF): around a joint 936 and around a joint 937. According to one embodiment, the joint 937 may be created by attaching the support structure 938 to the intermediate phalanx 935. The finger 900 also includes a control circuit 939. Joint motion in the finger 900 may be accomplished with motors (not shown), or another device or mechanism serving a similar purpose. According to one embodiment, an accelerometer (not shown) may be used as a sensor to track the motion of finger 900. [0098] FIG. 10 is an illustration of a static and dynamic model aesthetic prosthesis according to one embodiment. A person using the static prosthetic 1043 has a disadvantage as the static prosthetic does not follow the motion of the other fingers on the hand while writing with a pen. An accelerometer may be embedded within a sensing ring 1041 or a sensing band 1042 and mounted on a finger, such as the pinkie finger.
[0099] A person using a dynamic prosthetic 1044 adjusts motion of the aesthetic prosthetic to the motion of the other fingers on the hand. Sensing devices on the pinkie finger and ring finger prosthetic apparatus may be synchronized in such a way that the ring finger will always follow the pinkie finger. According to one embodiment, behavior for the aesthetic prosthesis is designed to mimic the human action measured corresponding activities measured in FIGs.6, 7, and 8. For example, when a sensor in the prosthesis records waveforms similar to those measured when picking up a cell phone, the motors in the prosthesis may be activated to move the prosthetic finger in a similar fashion. Power for the mechanical devices in the dynamic prosthetic may be powered wirelessly by a watch, or similar device, in proximity of the prosthetic. According to one embodiment, the watch or another device may be powered mechanically by human motion or a battery.
[00100] FIG. 11 is a block diagram illustrating a system for controlling a dynamic prosthetic according to one embodiment. A microcontroller 1102 is coupled to a motor 1104 in the dynamic prosthetic and a sensor 1106 for measuring motion of the dynamic prosthetic. For example, the microcontroller 1102 may output commands to the motor 1104. The sensor 1106 may measure the output of the motor 1104 and provide input to the microcontroller 1102 to produce a feedback loop. Additionally, the microcontroller 1102 may receive input from a sensing device 1108 and a sensing device 1110 through a wired coupling or a wireless connection. The sensing devices 1108, 1110 may be, for example, mounted on a ring finger and a pinkie finger of a hand, respectively. Additionally, a controller or power source may be located in a wrist watch 1112. The wrist watch 1112 may couple to the microcontroller 1102 through a wire or wirelessly. According to one embodiment, other actuators may be substituted for the motor 1104. [00101] Although the description above refers to manufacturing a prosthetic finger, other prosthetics may be manufactured according to the disclosure such as, for example, hands, toes, feet, arms, and legs.
[00102] A prosthetic manufactured as described above may be manufacturing in one location and shipped around the world allowing prosthetics to become available world-wide. Additionally, the method may be used to develop robotic hands. Further, the manufacturing process may be used to create artificial hands with or without motion for the entertainment industry. For example, hands may be manufactured for the film industry, amusement parks, festivals, or Halloween decoration.
Temperature Regulation
[00103] In order to create more lifelike devices, temperature regulation may be offered as an optional feature of anatomical members formed according to the embodiments described above. For example, according to one aspect of the present disclosure, the skin temperature of the user may be mimicked on his prosthetic device. For example, a temperature monitoring and control system may be placed remote from the prosthetic device on a wearable strap to mimic human skin temperature characteristics and use the control information from this remote system to drive a heating element embedded in the prosthetic device to a controlled temperature similar to human skin. According to one embodiment, the heating device may include a flexible heating element. According to another embodiment, the prosthetic device includes a controller that helps mimic human skin temperature characteristics by dynamically detennining and regulating a temperature of the prosthetic device with varying room temperature. According to one embodiment, a portion of the prosthetic device may be wearable on a wrist band/watch.
[00104] A system for heating a prosthetic device to substantially mimic human skin temperature may include a heating element, a calibration unit, and a temperature control unit. FIG. 12 is a block diagram illustrating an exemplary temperature monitoring and control system for a prosthetic replacement according to one embodiment. A system for regulating temperature may include a temperature control unit 100, a temperature sensor 110, a power supply 130, and a calibration unit 120. According to one embodiment, the temperature control unit 100 includes a microcontroller. Wires 132 couple the temperature control unit 100 to a heating element 160 in a prosthetic replacement 140. According to one embodiment, the power supply 130 may be a battery. The prosthetic replacement 140 may be, for example, an arm, a hand, a finger, a toe, a foot, or a leg. Additionally, the system for heating a prosthetic device may be used for internal skin surfaces and membranes, such as orifices, as well as external skin surfaces.
[00105] FIG. 13 is a cross-sectional view illustrating an exemplary prosthetic finger with an enclosed heating element according to one embodiment. FIG. 14 is a top view illustrating an exemplary heating element in a prosthetic finger according to one embodiment. FIG. 15 is a front cross-sectional view illustrating an exemplary prosthetic finger with a heating element according to one embodiment. A heating element 160 may be embedded in a prosthetic replacement 140. The heating element 160 may be embedded in the prosthetic replacement 140 and drive heat to the surface of the prosthetic replacement.
[00106] According to one embodiment, the heating element 160 may be a resistive heating element. FIG. 16 is a side view illustrating an exemplary resistive heating element for use in a prosthetic device according to one embodiment. FIG. 17 is a top view illustrating an exemplary resistive heating element for use in a prosthetic device according to one embodiment. The heating element 160 may be driven by the temperature control unit 100 by coupling wires 122 to the wires 132. A bone structure of the prosthetic replacement 140 may provide supporting structure for the heating element 160.
[00107] The temperature calibration unit 120 of FIG. 12 may provide temperature data to the temperature control unit 100 for selecting a temperature to warm the prosthetic replacement 140. According to one embodiment, the temperature calibration unit 120 measures the temperature on the surface of a sample skin material of known thickness, which is read and stored in the temperature control unit 100, and adjusts the power delivered to the prosthetic replacement 140 to mimic human skin temperature characteristic.
[00108] FIG. 18 is a side cross-sectional view of an exemplary remote dynamic calibration unit for use in a prosthetic device according to one embodiment. A remote dynamic calibration unit 700 may include a sample skin material 702 of known thickness placed between a heating element 706 and a temperature sensor 704. The calibration unit 700 may apply heat to the sample skin 702 and measure the resulting temperature of the sample skin 702 with the temperature sensor 704. If the heating element 706 is a resistive heating element, the calibration unit 700 may apply a series of currents to the sample skin 702 and measure the temperature of the sample skin 702 with the temperature sensor 704 for each applied current. The resulting table of current and temperature values may be used by the temperature control unit 100 for applying heat to the prosthetic replacement 140.
[00109] According to one embodiment, the temperature control unit 100 may be attached to a strap 150 such as a watch or bracelet. FIG. 19 is a block diagram illustrating an exemplary wearable strap for a prosthetic device according to one embodiment. A strap 150 may include the temperature control unit 100, the temperature sensor 110, the calibration unit 120, and the power supply 130. According to one embodiment, the temperature control unit may be built on a flexible printed circuit board (PCB).
[00110] FIG. 20 is a front view illustrating an exemplary temperature sensing element for a prosthetic device according to one embodiment. According to one embodiment, the temperature sensor 110 may be embedded in the strap 150 to provide measurements of a human's actual skin temperature. For example, if the strap 150 is worn around a user's body and coupled to the prosthetic replacement 140, the embedded temperature sensor 110 may provide measurements of the user' s skin temperature to the temperature control unit 100. The temperature control unit 100 may use the measured skin temperature to determine, in part, the temperature of the prosthetic replacement 140.
[00111] The prosthesis temperature may also be regulated by using a temperature sensor to measure the ambient temperature and drive a heating element based on a lookup table. The look up table may be acquired by prior measurement of human skin temperature profiles at several ambient temperatures. Temperature profiles for different persons may be measured and stored as a lookup table. The temperature control unit 100 may use the measured ambient temperature and the lookup table corresponding to the user to deliver power to the heating element. According to one embodiment, power is delivered by estimating the duty cycle for the pulse width modulator (PWM). Therefore, the prosthetic replacement is elevated to a desired human skin temperature.
[00112] FIG.21 is a block diagram illustrating an exemplary circuitry for temperature sensing and heat control according to one embodiment. According to one embodiment, the heating element 160 may be driven by a power field effect transistor (FET) 950, and the heating element 706 may be driven by a power FET 960. Power FETS may have a very low on resistance to reduce power loss in the FET thereby improving the efficiency of the heating system. The power FETs 950, 960 may be controlled by a pulse width modulator (PWM) 940. The modulator 940 may be controlled to vary pulse width during run time based, in part, on calibration data from the calibration unit 120. According to one embodiment, a PWM-based power controller circuit receives a temperature from the temperature sensor 704 and from the temperature sensor 110 at a two-channel analog to digital converter 970. The temperatures may be received from the sensors 110, 704 as voltages proportional to the temperatures. The sensed voltage serves as a root for finding the calibration data based on a formula obtained from human skin temperature and prosthetic skin material characteristics.
[00113] According to one embodiment, the prosthetic replacement 140 may be part of a teaching dummy. The teaching dummy may be used to teach medical students to treat and care for the patients. For example, intelligent mannequins for use as automated nurses may be fitted with a heating control system to provide more humanistic appeal using the method described. According to another embodiment, the prosthetic replacement 140 may be integrated into a sex doll.
[00114] FIG. 22 is a flow chart illustrating a method for regulating a temperature of a prosthetic replacement according to one embodiment. At block 1102 temperatures of a human skin is measured and a sample skin material is measured. At block 1104 power to a heating element in the prosthetic replacement is regulated to elevate the temperature of the prosthetic replacement to a temperature range approximately equal to the measured human skin temperature.
[00115] FIG. 23 is a flow chart illustrating a method for regulating a temperature of a prosthetic replacement according to one embodiment. At block 1202 the ambient temperature is measured. At block 1204 power is regulated to a heating element in the prosthetic replacement based, in part, on a lookup table to elevate the temperature of the prosthetic replacement to a desired temperature range.
Tactile Sense Duplication [00116] In order to create more functional and responsive devices, tactile sense duplication may be offered as an optional feature of anatomical members formed according to the embodiments described above. For example, in some embodiments a biologically inspired approach may provide robots or paralyzed humans with the perception of local touch on their fingers which mainly concerns the recognition of objects through their local shapes such as curvatures, angles, and edges. The tactile perception may be signified with a sulcate skin cover which simulates human skin with fingerprints.
[00117] In some embodiments, local shapes of objects' surfaces, which mainly consist of surface curvatures, can be learned and recognized through touch by robotic/prosthetic hands. This invention can be used preferably with 3-dimensional tactile sensors, i.e. the sensors that can provide three force vectors comprising one normal, two tangential, and further, one additional force vector that is the total of the former three loads. However, it should be noted that in some embodiments 1 -dimensional or 2 -dimensional tactile sensors may be used. In some embodiments, a 2x2 sensor may be used, which can detect and measure the pressure value when it comes into contact with objects. This sensor pad in particular consists of four small sensors placed on the four sides of a square. In some embodiments, a commercially available sensors may be used.
[00118] In some embodiments, for each sensor of the sensor pad three force components may be generated which are measured along the three spatial axes of x, y, and z. The corresponding resultant data of the 3D force may then be able to be exported for further use. When sensors contact the surface to be detected, the resultant 3D forces which the sensors sense at different locations on the surface may be different owing to the curvature of the surface. Therefore, the resultant 3D forces may reflect the local shape correctly.
[00119] The statistical features of the resultant 3D force data may be extracted while noise may be removed to provide an improved measurement. Based on the extracted statistical features, various learning approaches, for example classifiers including Neural Network, naive Bayes, and various Kernel functions with different corresponding parameters for Support Vector Machine (S VM), may be executed to construct connections among the data so as to achieve the desirable performance of the classifiers. With this methodology, the resultant 3D force is the only requisite to achieve the local shape recognition function. [00120] In some embodiments, to humanize tactile sensors, two skin covers each having four hollows that match the four bumps of tactile sensors on the sensor pad may be used. One may be a sulcate skin cover which simulates the human fingerprints and the other may be a flat one.
[00121] In association with the skin cover, the following considerations may apply: 1) the skin covers may be elastic and not sticky and not slippery, and 2) the skin covers may be placed exactly on top of the sensor pad.
[00122] In some embodiments, three basic curvatures may be discriminated. As shown in FIG. 24, a sensor may be implemented to collect sensory data from objects' surfaces.
[00123] FIGs. 25A and C show side and perspective views of one embodiment of a sulcate skin cover that may simulate the fingerprints' role and may be placed on the sensors. This cover with its ridges may perform spectral selection and amplification of the tactile information about physical properties of an object. In some embodiments, a flat skin cover with its structure shown in FIGs. 25B and D may be used.
[00124] FIG. 26A-C show three objects having three different shapes. The three different objects have a front shape that is: flat (FIG. 26A), edged (FIG. 26B), and convex curved with a curvature of 0.4 mm"1 (FIG. 26C). These objects may be used to show the force profile on a pressure sensor. For each curvature 40 samples of force data may be collected.
[00125] As shown in FIGs. 27A and B, in some embodiments, objects may be applied vertically on the skin covers and to the center of the sensors. It should be noted that since some embodiments are targeted for local shape recognition, in some cases the size of objects should not be much larger than the sensor pad size; otherwise, as the sensors are immobilized with regard to the objects, the curved one in contact with the sensors will be felt as a flat surface.
[00126] FIG 28: shows three sets of raw experimental data for each of the three objects. The graphs are shown for both skin covers. The experimental data for each skin cover with each of the objects is collected from different runs of the experiments carried out in the same condition. Each graph presents four responses corresponding to the resultant forces from the four sensors of the tactile sensor array. [00127] In some embodiments, a signal processing method may be used to process the measurements from the sensors. The processing may reduce noise which can degrade the quality of the desired measurement. For this purpose, a Finite Impulse Response (FIR) filter may be used. FIG.29A shows examples of the filtered 3D force resultants collected from four sensors on the tactile sensor array with flat skin cover. FIG. 29B shows the examples of the filtered 3D force resultants collected from four sensors on the tactile sensor array with sulcate skin cover.
[00128] In some embodiments, the sensory data (the resultant 3D force filtered or not filtered by the FIR) may be decomposed into its constructing features. For example, the sensory data may be decomposed into statistical features such as mean, standard deviation, and the maximum value of the force signals.
[00129] In some embodiments, information from the sensors may then be employed to construct connections among stored data through training various classifiers using samples. For example, 30 samples of each curvature may be used while the other 10 samples of each class may be held for validation. For this purpose, Neural Network, naive Bayes, and various Kernel functions with different corresponding parameters for Support Vector Machine (SVM) can be used to achieve improved performance on the validation dataset for both flat and sulcate skin covers. Table 1 shows the accuracy rate results of different classifying approaches for testing the above-mentioned three different objects having three different shapes utilizing a flat skin cover.
Figure imgf000027_0001
"·ρ = 2 72.5% 79.2% 86.7% 90% 92.5% 94.2% 52.5% 65% 77.5% 77.5% 80.8% 81.7%
P = 3 62.5% 71.7% 82.5% 85% 86.7% 92.5% 41.7% 46.7% 67.5% 68.3% 75.8% 81.7% p = 4 50% 61.7% 72.5% 78.3% 85% 88.3% 37.5% 47.5% 50% 57.5% 62.5% 74.2% p = 5 43.3% 53.3% 69.2% 71.7% 77.5% 85.8% 34.2% 42.5% 46.7% 46.7% 52.5% 61.7%
SVM with C = C = C =
C = 1 C = 5 C = 10 C = 20 C = 0.3 C = 1 C = 5 C = 10 C = 20 RBF Kernel 0.3 100 100
®y = 0.1 81.7% 86.7% 91.7% 92.5% 94.2% 98.3% 78.3% 75% 84.2% 83.3% 85% 88.3%
Y = 0.3 85.8% 92.5% 94.2% 95.8% 98.3% 98.3% 77.5% 80.8% 85% 85.8% 87.5% 90% y = 0.5 90% 92.5% 95.8% 97.5% 97.5% 99.2% 79.2% 84.2% 83.3% 86.7% 85% 90%
Table 1.
Table 2 shows the accuracy rate results of different classifying approaches for testing the above- mentioned three different objects having three different shapes utilizing a sulcate skin cover.
Figure imgf000028_0001
•••p = 2 81.7% 81.7% 85% 87.5% 88.3% 94.2% 94.2% 94.2% 95.8% 95.8% 95% 96.5% p = 3 71.7% 71.7% 71.7% 78.3% 85% 86.7% 93.3% 92.5% 95.8% 95% 95.8% 96.5% p = 4 65% 65% 65% 65% 67.5% 83.3% 90% 90.8% 93.3% 93.3% 95.8% 96.5% p = 5 59.2% 59.2% 59.2% 59.2% 59.2% 65.8% 84.2% 85% 89.2% 91.2% 95% 95%
SVM with C = C = C =
C = 1 C = 5 C = 10 C = 20 C = 0.3 C = 1 C = 5 C = 10 C = 20 RBF Kernel 0.3 100 100
®y = 0.1 86.7% 88.3% 92.5% 95% 95.8% 99.2% 91.7% 93.3% 95% 95.8% 95.8% 96.5% γ = 0.3 87.5% 89.2% 95.8% 96.7% 99.2% 100% 93.3% 95% 95.8% 95.8% 95.8% 95% y = 0.5 88.3% 91.7% 96.7% 98.3% 98.3% 100% 95% 95% 95.8% 95.8% 96.5% 93.3%
Table 2.
[00130] FIG. 30 shows a comparison of the maximum accuracy rates for various recognition algorithms for 120 data samples collected. One may notice that SVM with a radial basis function Kernel may result in the best recognition of objects' local shape. On the other hand, a remarkable improvement may be noticed in performances by employing sulcate skin cover rather than a flat one. In some embodiments, the improvement in performance may be due to the fact that a sulcate skin cover simulates fingerprints, which may boost the detailed force information received from an object's shape.
[00131] FIG. 31 shows the results of an experiment that sought to determine the accuracy of measurements of object with different shapes. As one may note, of another 120 measured surfaces— the first 40 samples are flat objects, the second 40 are edged objects, and the third 40 are curved objects— the experimental results of an embodiment of the invention resulted in an accuracy of 97.5% recognition rate.
[00132] In some embodiments, algorithms, or artificial intelligence may be used to "learn" from previous measurements. Applying trained models of known objects to measurements of unknown objects may allow the system to deduce the shape of the unknown objects. [00133] In some embodiments, the proposed apparatus and methods may be used in robotic and/or prosthetic hands by providing local tactile sense. Some advantages include a fast and simple algorithm as well as humanlike skin cover with fingerprints which may play an essential role for both sociable robots and amputees to be embraced in social life.
[00134] In some embodiment, the proposed apparatus and methods may be used in various prosthetic replacements and robotic limbs.
EXAMPLE
[00135] The following is a description of an example that embodies some embodiments of the invention. The example is presented by way of illustration, not limitation.
[00136] Following the biological learning approach, Support Vector Machine (S VM), Neural Networks (NN), and Naive Bayes, which are pattern recognition methods, are implemented to discriminate three different curvatures of objects using the sensory data collected through experiments. These experiments have been carried out by a commercially available 2 <2 sensor pad (FIG. 24). To humanize the tactile sensors, a sulcate skin cover (FIG. 25, A and C) which simulates the fingerprints' role is placed on the top of the sensors. It performs spectral selection and amplification of the tactile information about physical properties of an object which is verified by repeating the same set of experiments for flat skin cover (FIG. 25, B and D). Then, three different objects with flat (FIG. 26A), edged (FIG. 26B), and convex curved with a curvature of 0.4 mm"1 (FIG. 26C) surfaces were applied vertically on the skin covers and to the center of the four sensors on the pad (FIG. 27) to obtain their force profile (FIG. 28). For each curvature 40 samples of force data were collected. It should be noted that since these experiments are targeted for local shape recognition, the size of objects should not be much larger than the sensors pad size; otherwise, as the sensors are immobilized, the curved object in contact with the sensors will be felt as a flat surface.
[00137] As any other physical experiment, due to the equipments and measurements errors, the collected data are noisy. Thus, re-arranging and noise elimination/reduction of the pressure signals becomes one of the important steps before classification. For noise reduction, choosing an appropriate filter with proper characteristics which are dependent to the data sets' characteristics is essential. When an input signal to a system contains extra unnecessary content or additional noise which can degrade the quality of the desired portion, a filter is designed based on the noise frequency range. In the study, the inventors designed a Finite Impulse Response (FIR) low pass filter to process the experimental data. For this purpose, first we determined the cut-off frequency. A well known approach to achieve this is to form the Fourier transform of the pressure signals and then obtain the frequency in which the power of the signal reduces to half of the initial power. Next, based on the cut-off frequency, bandwidth of the pass-band and stop-band were drawn. (FIG. 29) shows a typical filtering result of the force data.
[00138] Next, the sensory data were decomposed into their constructing features. This step is called feature extraction which is to select the optimum representations of a given dataset that contains the most useful information of the dataset and results in a desirable performance of the classifier. These features should be chosen carefully such that for each class they gather the most salient and distinguishable information. Due to the huge influence of feature extraction on classification results, in this study, first the dataset for each class were sketched to provide a good understanding of their differences. Based on the observations, we selected the statistical features such as mean, standard deviation, and the maximum value of the 3D resultant force signals. It is worth mentioning that each collected data included four subsets of data from the four sensors of the pad, and each of these four subsets corresponded to the total force signal of the normal and tangential forces. Therefore, an overall twelve features (4 subsets x 3 statistical features) were extracted and then stored from each collected data.
[00139] This information was next employed to construct connections among the stored data through training various classifiers using only 30 samples of each curvature (the other 10 samples of each class were held for validation). For this purpose, NN, naive Bayes, and various Kernel functions with different corresponding parameters for S VM were investigated to achieve the best performance on the validation dataset for both flat and sulcate skin covers (See Table 1 and 2 for details). A comparison of the average accuracy rates (FIG. 30) depicts that sulcate skin cover and SVM with radial basis function Kernel result in the best recognition of objects' local shape. Subsequently, the parameters of the chosen algorithm with sulcate skin cover were adjusted via cross validation.
[00140] To verify the performance of the trained biologically-inspired learning algorithm, another set of experiments have been conducted. The collected data were processed following the same procedure to assess the recognition rate of objects with different curvatures. It was observed that 97.5% of the curvatures were recognized correctly (See FIG. 31 for details).
[00141] All of the methods disclosed and claimed herein can be made and executed without undue experimentation in light of the present disclosure. While the apparatus and methods of this invention have been described in terms of preferred embodiments, it will be apparent to those of skill in the art that variations may be applied to the methods and in the steps or in the sequence of steps of the method described herein without departing from the concept, spirit and scope of the invention. In addition, modifications may be made to the disclosed apparatus and components may be eliminated or substituted for the components described herein where the same or similar results would be achieved. All such similar substitutes and modifications apparent to those skilled in the art are deemed to be within the spirit, scope, and concept of the invention as defined by the appended claims.

Claims

WHAT IS CLAIMED IS:
1. A method for manufacturing an anatomical member, comprising:
receiving electronic information defining one or more anatomical characteristics of a customer;
processing the information to generate a model of the anatomical member; and forming the anatomical member from the model.
2. The method of claim 1 , wherein the anatomical unit is a prosthesis.
3. The method of claim 1, wherein the anatomical unit is robotic.
4. The method of claim 1, further comprising providing one or more rigid structures corresponding to anatomical features of the customer defined in the electronic information.
5. The method of claim 2, further comprising integrating the one or more anatomical features with the anatomical member.
6. The method of claim 1 , further comprising
measuring temperatures of a human skin and a sample skin material; and
regulating power to a heating element in the anatomical member to elevate the temperature of the prosthetic replacement to a temperature within a predetermined range of the measured human skin temperature.
7. The method of claim 1, further comprising providing a temperature regulation unit for regulating the temperature of a surface of the anatomical member.
8. The method of claim 7, wherein providing a temperature regulation unit further comprises:
providing a temperature control unit;
providing a temperature calibration unit configured to be coupled to the temperature control unit; and
providing a power supply configured to be coupled to the temperature control unit, in which the temperature control unit regulates an output of the power supply to regulate the temperature of the prosthetic replacement.
9. The method of claim 1 , further comprising:
providing a plurality of sensors coupled to a surface of the anatomical member, where each sensor configured to measure force in at least one direction; providing a cover coupled to the plurality of sensors;
measuring an output from each of the plurality of sensors; and
interpreting the output of each of the plurality of sensors to determine a characteristic of a surface in contact with the cover.
10. A method for manufacturing an anatomical member, comprising:
receiving information from a customer electronically;
processing the information according to at least one of a static or dynamic model; forming a mold for the prosthetic according to the model; and
filling the mold to form the anatomical member.
11. The method of claim 10, wherein the anatomical member is a prosthesis.
12. The method of claim 10, in which receiving the information comprises receiving at least one of a computed tomography (CT) scan, a photograph, personal information, payment information, and insurance information.
13. The method of claim 10, in which processing the information comprises obtaining data to produce a mirror image of a remaining appendage of the customer.
14. The method of claim 10, in which processing the information comprises extracting information about at least one of a bone, a bone density, a bone position, and a bone structure.
15. The method of claim 10, in which processing the information comprises extracting information about at least one of a body part, a size of a body part, a skin texture of a body part, and a skin density of a body part of the customer.
16. The method of claim 10, in which processing the information comprises designing at least one of a motor, sensor, and actuator to attach to the anatomical member.
17. The method of claim 10, further comprising attaching a ring to the anatomical member, in which the ring anchors the anatomical member to the customer.
18. The method of claim 10, in which receiving the information comprises receiving the information via the Internet.
19. The method of claim 10, further comprising shipping the anatomical member to the customer.
20. The method of claim 10, in which the prosthetic is a finger.
21. A mold for an anatomical member, comprising:
a first half and a second half coupled together by screws;
a void between the first half and the second half corresponding to the shape of the anatomical member as defined by a model generated from electronic information provided by a customer;
a pin for affixing a position of a bone member in the void; and
injection holes for injecting material into the void.
22. The mold of claim 21 , in which the void comprises a location for at least one of a motor, an actuator, and a sensor.
23. The mold of claim 21 , in which the anatomical member is a prosthesis.
24. The method of claim 21, in which the anatomical member is a finger.
25. The mold of claim 21 , further comprising an interlocking ridged bonding structure.
26. An apparatus for regulating a temperature of a prosthetic replacement, comprising: a temperature control unit; a temperature calibration unit coupled to the temperature control unit; and a power supply coupled to the temperature control unit, in which the temperature control unit regulates an output of the power supply to regulate the temperature of the prosthetic replacement.
27. The apparatus of claim 26, further comprising a temperature sensor coupled to the temperature control unit.
28. The apparatus of claim 27, in which the temperature control unit comprises:
a pulse width modulator (PWM) coupled to a power field effect transistor (FET); an analog-to-digital (ADC) converter coupled to the temperature sensor; and a programmable logic device coupled to the PWM and coupled to the ADC, in which the programmable logic device controls the PWM based, in part, on an output of the
ADC.
29. The apparatus of claim 26, in which the temperature control unit is mounted on a flexible printed circuit board (PCB).
30. The apparatus of claim 26, further comprising a heating element coupled to the temperature control unit, in which the temperature control unit elevates the temperature of the prosthetic replacement by applying power to the heating element.
31. The apparatus of claim 26, in which the temperature control unit, the temperature calibration unit, and the power supply are attached to at least one of a wearable strap, bracelet, and watch.
32. The apparatus of claim 26, in which the temperature control unit regulates the temperature of the prosthetic replacement to substantially mimic a human skin temperature.
33. The apparatus of claim 26, in which the prosthetic replacement is at least one of an arm, a hand, a finger, a toe, a foot, and a leg.
The apparatus of claim 26, in which the temperature calibration unit comprises: a skin material sample substantially similar to a material of the prosthetic replacement; a temperature sensor in proximity of the sample skin material on a first side of the sample skin material; and
a heating element in proximity of the sample skin material on a second side opposite the first side of the sample skin material.
35. A method for regulating a temperature of a prosthetic replacement, comprising:
measuring temperatures of a human skin and a sample skin material; and
regulating power to a heating element in the prosthetic replacement to elevate the temperature of the prosthetic replacement to a temperature range approximately equal to the measured human skin temperature.
36. The method of claim 35, in which measuring the human skin temperature comprises measuring the human skin temperature with a temperature sensor embedded in a strap.
37. The method of claim 35, further comprising:
applying a power level to a sample heating element in proximity to the sample skin material;
measuring a calibration temperature of the sample skin material after applying the power level to the sample heating element; and
determining a power output to the heating element based, in part, on the calibration temperature of the sample skin material.
38. The method of claim 35, in which measuring the temperature of the human skin comprises measuring the temperature of at least one of an arm, a hand, a finger, a foot, a toe, and a leg.
39. A method for regulating a temperature of a prosthetic replacement, comprising:
measuring the ambient temperature; and
regulating power to a heating element in the prosthetic replacement based, in part, on a lookup table to elevate the temperature of the prosthetic replacement to a desired temperature range.
40. The method of claim 39, further comprising measuring human skin temperature profiles at various ambient temperatures to form the lookup table.
41. The method of claim 40, further comprising storing the lookup table in a temperature control unit.
42. The method of claim 39, in which regulating power to the heating element comprises estimating a duty cycle for a pulse width modulator.
43. The method of claim 39, in which the prosthetic replacement is at least one of an arm, a hand, a finger, a foot, a toe, and a leg.
44. An apparatus for measuring the contours of a surface comprising:
a plurality of sensors, each sensor configured to measure force in at least one direction; a cover coupled to the plurality of sensors; and
a measurement module configured to receive information from the plurality of sensors and determine a characteristic of a surface touching the cover.
45. The apparatus of claim 44, where the cover is sulcate.
46. The apparatus of claim 44, where the cover comprises silicone rubber.
47. The apparatus of claim 44, where the cover is flat.
48. The apparatus of claim 44, where the plurality of sensors comprises four sensors.
49. The apparatus of claim 44, where each sensor is configured to measure force in three dimensions.
50. The apparatus of claim 44, where the characteristic is the curvature of the surface.
51. The apparatus of claim 44, where the characteristic is the edge of the surface.
52. A method for measuring the contours of a surface, the method comprising: providing a plurality of sensors, where each sensor configured to measure force in at least one direction;
providing a cover coupled to the plurality of sensors;
measuring an output from each of the plurality of sensors; and
interpreting the output of each of the plurality of sensors to determine a characteristic of a surface in contact with the cover.
53. The method of claim 52, wherein the cover is sulcate.
54. The method of claim 52, where the cover comprises silicone rubber.
55. The method of claim 52, where the cover is flat.
56. The method of claim 52, where providing the plurality of sensors comprises providing four sensors.
57. The method of claim 52, where each sensor is configured to measure force in three dimensions.
58. The method of claim 52, further comprising utilizing learning approaches to improve interpreting the output of each of the plurality of sensors.
59. The method of claim 52, where the characteristic is the curvature of the surface.
60. The method of claim 52, where the characteristic is the edge of the surface.
PCT/SG2011/000255 2010-07-15 2011-07-15 Apparatuses, systems, and methods for prosthetic replacement manufacturing, temperature regulation and tactile sense duplication WO2012008930A1 (en)

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