Conductive connection systems for use in connection with prosthesis liners

Abstract

A prosthetic system includes a flexible liner which conforms to a residual limb of a user and is configured to transmit electrical signals to one or more electronic components associated with the liner. The electronic components are in electrical connection with one or more liner conductive contacts attached to the outer surface of the liner. The prosthetic system further includes a prosthetic socket which is more rigid than the liner. An inner surface of the socket conforms generally to a shape of the liner and is donned over the liner. One or more socket inner conductive contacts are attached to the inner surface of the socket. Each of the socket inner conductive contacts is configured to move into electrical contact with at least one of the liner conductive contacts during donning.

Description

CONDUCTIVE CON N ECTION SYSTEMS FOR USE IN CON NECTION WITHPROSTHESIS LINERSCROSS-REFERENCE TO RELATED APPLICATIONS

[0001] This application claims benefit of U.S. Provisional Patent Application Serial No. 63 / 557,042, filed February 23, 2024, the disclosure of which is incorporated herein by reference.BACKGROUND ART

[0002] The following information is provided to assist the reader in understanding technologies disclosed below and the environment in which such technologies may typically be used. The terms used herein are not intended to be limited to any particular narrow interpretation unless clearly stated otherwise in this document. References set forth herein may facilitate understanding of the technologies or the background thereof. The disclosure of all references cited herein are incorporated by reference.BACKGROUND OF THE INVENTION

[0003] Liner suspension has long been a popular and effective suspension method for connecting artificial limbs comfortably and securely to the residual limb of the user. While their flexibility and ease of use has proven advantageous for their main purpose, those liners make it challenging to integrate or associate electronic components such as sensors or other hardware into or with the device. Such sensors are useful to investigate various biomechanical variables or to monitor the skin / liner interface.

[0004] Electronic hardware in the form of vibration motors has been incorporated into prosthesis liners to provide vibration therapy for phantom limb pain. In that regard, phantom limb pain and volume fluctuations are common issues among the population of individuals with amputations. Phantom limb pain can cause extreme discomfort to the patient and lead to other issues such as depression. Pain leads to less compliance of using their device, which promotes a sedentary lifestyle, in turn resulting in depression. Vibration therapy may be effective at decreasing the intensity of phantom limb pain.

[0005] A recurring challenge with any instrumented prosthetic liners is the transmission of power and data / control signals to electrical components incorporated in or otherwise in electrical connection with a prosthetic liner. For example, wires are susceptible to damagefrom being bent or stretched with the liner wall. Another problem is the termination of the wires at the cut end of the liner which may interfere with the regular donning and doffing of the liner.SUMMARY OF THE INVENTION

[0006] A prosthetic system includes a flexible liner configured to conform to a residual limb of a user. One or more liner conductive contacts are attached to the outer surface of the flexible liner. Each of the one or more liner conductive contact is configured to be placed in electrical connection with at least one of one or more electronic components. The system further includes a prosthetic socket which is more rigid than the flexible liner. An inner surface of the prosthetic socket conforms to a shape of the flexible liner when the flexible liner is donned by the user such that the prosthetic socket is configured to be donned over the flexible liner when the flexible liner is donned. One or more socket inner conductive contacts are attached to the inner surface of the prosthetic socket. Each of the one or more socket inner conductive contacts is positioned on the inner surface of the prosthetic socket and is configured to move into electrical contact with at least one of the one or more liner conductive contacts during donning of the prosthetic socket over the flexible liner. Each of the one or more socket inner conductive contacts is in electrical connection with at least one of one or more socket outer conductive contacts attached to an outer surface of the prosthetic socket.

[0007] In a number of embodiments, each of the one or more socket inner conductive contacts is in electrical connection with at least one of one or more socket outer conductive contacts in a manner that no extending electrical conductors therebetween are spaced from any surface of the prosthetic socket. In a number of embodiments, each of the one or more socket inner conductive contacts is in electrical connection with at least one of the one or more socket outer conductive contact via an extending conductor (i) which extends over and is in contact with the inner surface of the prosthetic socket, an upper rim of the prosthetic socket, and an outer surface of the prosthetic socket to be in electrical connection with the a different one of the one or more socket outer conductive contacts or (ii) which extends through a wall of the prosthetic socket to be in electrical connection with the different one of the one or more socket outer conductive contacts.

[0008] In a number of embodiments, each of the one or more liner conductive contacts may be electrically isolated from one or more others of the liner conductive contacts when there are more than one liner conductive contacts (and before the prosthetic socket is donned thereover). Each of the one or more socket inner conductive contacts may beelectrically isolated from one or more others of the socket inner conductive contacts when there are more than one socket inner conductive contacts. Each of the one or more socket outer conductive contacts may be electrically isolated from one or more others of the socket outer conductive contacts when there are more than one socket outer conductive contacts.

[0009] The prosthetic system may further include electronic circuitry in electrical connection with one or more electronic circuitry contacts. Each of the one or more electronic circuitry contacts may be configured to form an electrical connection with a different one of the one or more socket outer conductive contacts or with a different one of the one or more liner conductive contacts. The electronic circuity may further be configured to at least one of (i) transmit electrical signals to the one or more electronic circuitry contact and (ii) receive electrical signals via the one or more electronic circuitry contacts. Each of the one or more electronic circuitry contacts may further be configured to form a physical attachment with a different one of the one or more socket outer conductive contacts or with a different one of the one or more liner conductive contacts. The electrical signals may include at least one of a power signal and a data signal. In a number of embodiments, each of the one or more electronic circuitry contacts include a conductive hook-and-loop type connector. Each of the one or more socket outer conductive contacts may include a cooperating hook-and-loop type connector. Each of the one or more liner conductive contacts may include a cooperating hook-and-loop type connector.

[0010] In a number of embodiments, the flexible liner includes two or more liner conductive contacts to, for example, provide electrical signals (for example, electrical power) to the one or more electronic components from the electronic circuitry. The one or more electronic components may, for example, include one or more vibrators. The one or more vibrators may be incorporated within a flexible, elastomeric polymeric material of the flexible liner. The one or more vibrators may include one or more vibrational motors.

[0011] In a number of embodiments, the electronic circuitry includes a processor system, a memory system in communicative connection with the processor system, and a power system in electrical connection with the processor system and the memory system. The memory system may have one or more algorithms stored therein which are executable by the processor system. The one or more algorithms may be executable by the processor system to achieve at least one of (i) control electrical signals transmitted to the one or more electronic circuitry contacts and (ii) process electrical signals received from the one or more electronic circuitry contacts. The one or more socket outer conductive contacts may include a positive load outer socket and a negative load outer socket.

[0012] The electronic circuitry may be contained within a housing. In a number of embodiments, the housing includes one or more connectors configured thereon to connect to one or more cooperating connectors on the prosthetic socket. The one or more connectors of the housing may be hook-and-loop type connectors, and the one or more cooperating connectors of the prosthetic socket may be cooperating hook-and-loop type connectors.

[0013] The prosthetic system may further include a flexible wrap configured to be placed in connection with the flexible liner when the flexible liner is worn by the user without the prosthetic socket. The flexible wrap may include one or more first conductive contacts configured to be placed in electrical connection with the one or more liner conductive contacts attached to the outer surface of the flexible liner and one or more second conductive contacts configured to be placed in electrical connection with the electronic circuitry.

[0014] A method to provide electrical connection between one or more electronic components associated with a prosthetic system and electronic circuitry includes providing a flexible liner configured to conform to a residual limb of a user. One or more liner conductive contacts are attached to the outer surface of the flexible liner. Each of the one or more liner conductive contact is configured to be placed in electrical connection with at least one of the one or more electronic components. The method further includes providing a prosthetic socket which is more rigid than the flexible liner. An inner surface of the prosthetic socket conforms to a shape of the flexible liner when the flexible liner is donned by the user such that the prosthetic socket is configured to be donned over the flexible liner. One or more socket inner conductive contacts are attached to the inner surface of the prosthetic socket. Each of the one or more socket inner conductive contacts is positioned on the inner surface (of the prosthetic socket) and is configured to move into electrical contact with at least one of the one or more liner conductive contacts during donning of the prosthetic socket over the flexible liner. Each of the one or more socket inner conductive contacts is in electrical connection with at least one of one or more socket outer conductive contacts attached to an outer surface of the prosthetic socket.

[0015] The method further includes providing the electronic circuitry, which is in electrical connection with one or more electronic circuitry contacts. The electronic circuity is configured to at least one of (i) transmit the electrical signals to the one or more electronic circuitry contacts and (ii) receive electrical signals from the one or more electronic circuitry contacts. Each of the one or more electronic circuitry contacts is configured to form anelectrical connection with a different one of the one or more socket outer conductive contacts or with a different one of the one or more liner conductive contacts.

[0016] In a number of embodiments, each of the one or more electronic circuitry contacts forms an electrical connection with a different one of the one or more socket outer conductive contacts to be placed in electrical connection with the one or more electronic components via the one or more liner conductive contacts when the prosthetic socket is donned over the flexible liner being worn by the user, or each of the one or more electronic circuitry contacts forms an electrical connection with a different one of the one or more liner conductive contacts to be placed in electrical connection with the one or more electronic components when the prosthetic socket is not donned over the flexible liner being worn by the user.

[0017] Each of the one or more socket inner conductive contacts may be in electrical connection with at least one of one or more socket outer conductive contacts in a manner so that no extending electrical conductors therebetween are spaced from any surface of the prosthetic socket.

[0018] In a number of embodiments, each of the one or more liner conductive contacts is electrically isolated from one or more others of the liner conductive contacts when there are more than one liner conductive contacts (and before the prosthetic socket is donned over the flexible liner). Each of the one or more socket inner conductive contacts may be electrically isolated from one or more others of the socket inner conductive contacts when there are more than one socket inner conductive contacts. Each of the one or more socket outer conductive contacts may be electrically isolated from one or more others of the socket outer conductive contacts when there are more than one socket outer conductive contacts.

[0019] In a number of embodiments, each of the one or more socket inner conductive contacts is in electrical connection with at least one of the one or more socket outer conductive contacts via an extending conductor (i) which extends over and is in contact with the inner surface of the prosthetic socket, an upper rim of the prosthetic socket, and an outer surface of the prosthetic socket to be in electrical connection with a different one of the one or more socket outer conductive contacts or (ii) which extends through a wall of the prosthetic socket to be in electrical connection with the different one of the one or more socket outer conductive contacts.

[0020] In a number of embodiments, the one or more electronic components includes one or more vibrators. The one or more vibrators may be incorporated within a flexible,elastomeric polymeric material of the flexible liner. The one or more vibrators may include one or more vibrational motors.

[0021] In a number of embodiments, the electronic circuitry includes a processor system, a memory system in communicative connection with the processor system, and a power system in electrical connection with the processor system and the memory system. The memory system may have one or more algorithms stored therein which are executable by the processor system. The one or more algorithms may be executable by the processor system to at least one of (i) control the electrical signals transmitted to the one or more electronic circuitry contacts and (ii) process electrical signals received from the one or more electronic circuitry contacts. The electrical signal may include at least one of a power signal and a data signal.

[0022] The method may further include providing a flexible wrap configured to be placed in connection with the flexible liner when the flexible liner is worn by the user without the prosthetic socket. The flexible wrap may include one or more first conductive contacts configured to be placed in electrical connection with the one or more liner conductive contacts attached to the outer surface of the flexible liner and one or more second conductive contacts configured to be placed in electrical connection with the electronic circuitry.

[0023] A flexible liner for use with a prosthetic system, which includes a prosthetic socket, is configured to conform to a residual limb of a user. The flexible liner includes one or more liner conductive contacts attached to the outer surface of the flexible liner. Each of the one or more liner conductive contact is configured to be placed in electrical connection with at least one of one or more electronic components and to be placed in electrical connection with at least one of one or more liner conductive contacts during donning of the prosthetic socket over the flexible liner. The one or more liner conductive contacts are positioned on an interior surface of the prosthetic socket.

[0024] Each of the one or more liner conductive contacts may be electrically isolated from one or more others of the liner conductive contacts when there are more than one liner conductive contacts (and before the prosthetic socket is donned thereover.

[0025] A prosthetic socket, which is configured to be donned over a flexible liner of a prosthetic system worn by a user and is more rigid than the flexible liner, includes an inner surface conforming to a shape of the flexible liner when the flexible liner is donned by the user such that the prosthetic socket is configured to be donned over the flexible liner when the flexible liner is donned. The prosthetic socket further includes one or more socket innerconductive contacts attached to the inner surface of the prosthetic socket. Each of the one or more socket inner conductive contact is positioned on the inner surface (of the prosthetic socket) and is configured to move into electrical contact with at least one of one or more liner conductive contacts attached to an outer surface of the flexible liner during donning of the prosthetic socket over the flexible liner, each of the one or more socket inner conductive contacts being in electrical connection with at least one of one or more socket outer conductive contacts attached to an outer surface of the prosthetic socket.

[0026] Each of the one or more liner conductive contacts may be electrically isolated from one or more others of the liner conductive contacts when there are more than one liner conductive contacts (and before the prosthetic socket is donned thereover). In a number of embodiments, each of the one or more socket inner conductive contacts is electrically isolated from one or more others of the socket inner conductive contacts when there are more than one socket inner conductive contacts. Each of the one or more socket outer conductive contacts may be electrically isolated from one or more others of the socket outer conductive contacts when there are more than one socket outer conductive contacts.

[0027] The present devices, systems, and methods, along with the attributes and attendant advantages thereof, will best be appreciated and understood in view of the following detailed description taken in conjunction with the accompanying drawings.BRIEF DESCRIPTION OF DRAWINGS

[0028] FIG. 1 illustrates a cross-sectional view of a portion of a prosthetic device including a flexible socket interface or flexible liner or interface and a hard or rigid socket.

[0029] FIG. 2 illustrates the prosthetic device of FIG. 1 in operative connection with a leg.

[0030] FIG. 3 illustrates the prosthetic device of FIG. 1 worn by a user.

[0031] FIG. 4 illustrates a cross-sectional schematic view of a vibrator embedded within a flexible liner.

[0032] FIG. 5 illustrates schematically a cutaway view of a portion of a prosthetic system including one or more vibrators embedded within a flexible liner and a sensor in connection with the flexible liner, wherein the vibrator and the sensor are in operative connection with electronic circuitry exterior to the socket.

[0033] FIG. 6 illustrates schematically a partially cutaway view of a portion of a prosthetic system or device hereof including an embodiment of a conductive connection system of a prosthetic socket thereof wherein extending conductive elements such as lengths of wires, ribbons or tapes extend over an outer surface of the socket and over an interior surface thereof to connect to conductive connectors or contacts on an inner surface of the socket.

[0034] FIG. 7 illustrates schematically a front view (with respect to the orientation of the user) of an embodiment of a flexible liner for use in connection with a socket including a conductive connection system hereof.

[0035] FIG. 8 illustrates schematically a front view of an embodiment of a socket including a conductive connection system hereof for use in connection with the flexible liner of FIG. 7.

[0036] FIG. 9A illustrates schematically a front view of an embodiment of a system hereof with the flexible liner of FIG. 7 in operative connection with the socket of FIG. 8.

[0037] FIG. 98 illustrates schematically a front view of the system of FIG. 9A with the flexible liner of FIG. 7 in operative connection with the socket of FIG. 8 and a housing including electronic circuitry therein, which is connected to the socket.

[0038] FIG. 9C illustrates schematically a top view of an embodiment of electronic circuitry (for example, including a control system) hereof with the housing therefor in an open state.

[0039] FIG. 10 illustrates schematically a side, partially cutaway view of another embodiment of a system hereof wherein extending conductive elements such as wires or ribbons are embedded in or pass through the socket to connect to conductive connectors or contacts on an inner surface of the socket.

[0040] FIG. 11 illustrates a perspective view (from above the leg of a patient) of a liner including one or more vibrators worn on the leg of the patient and positioned within a transparent prosthetic socket, wherein a housing for electronic circuitry is attached to the prosthetic socket and load wires from the electronic circuitry are connected to electrical contacts of the socket to transmit electrical signals to the vibrators of the liner to administer vibration therapy to the patient.

[0041] FIG. 12 illustrates a perspective view (from below and in front of the leg of a patient) of the liner of FIG. 11 worn on the leg of the patient without a prosthetic socket thereover, wherein load wires from the electronic circuitry are connected directly to electrical contacts on the liner to transmit electrical signals thereto and thereby to the embedded vibrators in electrical connection with the contacts.

[0042] Fig. 13A illustrates schematically a top plan view of an embodiment of a conductive wrap hereof for use in connection with a liner and electronic circuitry in connection therewith.

[0043] FIG. 138 illustrates schematically a perspective view of the conductive wrap of FIG. 13A in operative connection with the liner worn on a leg of a patient and electronic circuitry in connection therewith.

[0044] FIG. 13C illustrates schematically a perspective view of the conductive wrap of FIG. 13A in operative connection with the liner and with the housing of the electronic circuitry wherein the housing of the electronic circuitry is connected to the conductive wrap.

[0045] FIG. 14A is a photograph illustrating a posterior view of a flexible liner used in a number of representative studies hereof which includes a pair of integrated vibrational motors located three centimeters from the distal end of the femur and four pairs of vibrational motors located eight to ten centimeters above the distal end of the femur and spaced circumferentially around the liner, wherein wires from each vibrational motor terminated under conductive hook-and-loop type contacts or pads

[0046] FIG 14B is a photograph illustrating an anterior view of a translucent socket used in a number of representative embodiment hereof with a housing for electronic circuitry attached thereto.

[0047] FIG. 14C is a photograph illustrating a posterior view of the socket of FIG. 14B donned over the flexible liner of FIG. 14ADESCRIPTION

[0048] It will be readily understood that the components of the embodiments, as generally described and illustrated in the figures herein, may be arranged and designed in a wide variety of different configurations in addition to the described representative embodiments. Thus, the following more detailed description of the representative embodiments, as illustrated in the figures, is not intended to limit the scope of the embodiments, as claimed, but is merely illustrative of representative embodiments.

[0049] Reference throughout this specification to "one embodiment" or "an embodiment" (or the like) means that a particular feature, structure, or characteristic described in connection with the embodiment is included in at least one embodiment. Thus, the appearance of the phrases "in one embodiment" or "in an embodiment" or the like in various places throughout this specification are not necessarily all referring to the same embodiment.

[0050] Furthermore, described features, structures, or characteristics may be combined in any suitable manner in one or more embodiments. In the following description, numerous specific details are provided to give a thorough understanding of embodiments. One skilled in the relevant art will recognize, however, that the various embodiments can be practiced without one or more of the specific details, or with other methods, components, materials, et cetera. In other instances, well known structures, materials, or operations are not shown or described in detail to avoid obfuscation.

[0051] As used herein and in the appended claims, the singular forms "a," "an", and "the" include plural references unless the context clearly dictates otherwise. Thus, for example, reference to "a vibrator" includes a plurality of such vibrators and equivalents thereof known to those skilled in the art, and so forth, and reference to "the vibrator" is a reference to one or more such vibrators and equivalents thereof known to those skilled in the art, and so forth. Recitation of ranges of values herein are merely intended to serve as a shorthand method of referring individually to each separate value falling within the range. Unless otherwise indicated herein, each separate value, as well as intermediate ranges, are incorporated into the specification as if individually recited herein. All methods described herein can be performed in any suitable order unless otherwise indicated herein or otherwise clearly contraindicated by the text.

[0052] The terms "electronic circuitry", "circuitry" or "circuit," as used herein include, but are not limited to, hardware, firmware, software, or combinations of each to perform a function(s) or an action(s). For example, based on a desired feature or need, a circuit may include a software-controlled microprocessor, discrete logic such as an application specific integrated circuit (ASIC), or other programmed logic device. A circuit may also be fully embodied as software. As used herein, "circuit" is considered synonymous with "logic." The term "logic", as used herein includes, but is not limited to, hardware, firmware, software, or combinations of each to perform a function(s) or an action(s), or to cause a function or action from another component. For example, based on a desired application or need, logic may include a software-controlled microprocessor, discrete logic such as an application specific integrated circuit (ASIC), or other programmed logic device. Logic may also be fully embodied as software.

[0053] The term "processor," as used herein includes, but is not limited to, one or more of virtually any number of processor systems or stand-alone processors, such as microprocessors, microcontrollers, central processing units (CPUs), and digital signal processors (DSPs), in any combination. The processor may be associated with various other circuits that support operation of the processor, such as random-access memory (RAM), read-only memory (ROM), programmable read-only memory (PROM), erasable programmable read only memory (EPROM), clocks, decoders, memory controllers, or interrupt controllers, etc. These support circuits may be internal or external to the processor or its associated electronic packaging. The support circuits are in operative communication with the processor. The support circuits are not necessarily shown separate from the processor in block diagrams or other drawings.

[0054] The term "controller / ' as used herein includes, but is not limited to, any circuit or device that coordinates and controls the operation of one or more input and / or output devices. As used herein, the term "and / or" in connection with, for example, A and / or B includes the cases of element A alone, element B alone, or elements A and B taken together. A controller may, for example, include a device having one or more processors, microprocessors, or central processing units capable of being programmed to perform functions.

[0055] The term "logic," as used herein includes, but is not limited to, hardware, firmware, software, or combinations thereof to perform a function(s) or an action(s), or to cause a function or action from another element or component. Based on a certain application or need, logic may, for example, include a software-controlled microprocessor, discrete logic such as an application specific integrated circuit (ASIC), or other programmed logic device. Logic may also be fully embodied as software. As used herein, the term "logic" is considered synonymous with the term "circuit."

[0056] The term "software," as used herein includes, but is not limited to, one or more computer readable or executable instructions that cause a computer or other electronic device to perform functions, actions, or behave in a desired manner. The instructions may be embodied in various forms such as routines, algorithms, modules, or programs including separate applications or code from dynamically linked libraries. Software may also be implemented in various forms such as a stand-alone program, a function call, a servlet, an applet, instructions stored in a memory, part of an operating system or other types of executable instructions. It will be appreciated by one of ordinary skill in the art that the form of software is dependent on, for example, requirements of a desired application, the environment it runs on, or the desires of a designer / programmer or the like.

[0057] As used herein, the term "vibrator" refers to a device to generate oscillation or vibration. Such devices may, for example, include piezoelectric devices, motor-driven vibratory devices, and the like. As used herein, the terms "prosthesis", "prosthetic" and the like refer to a device or methodology for replacement of a missing body part.

[0058] In a number of embodiments, the devices, systems, and methods hereof provide reliable, yet detachable or disconnectable, conductive connections between one or more electronic / hardware component(s) (such as sensors, heating systems, cooling systems, actuators (for example, vibrators), electrodes (which may be diagnostic or therapeutic electrodes such as, for example, EMG electrodes), transcutaneous energy transfer systems, receptors such as sensory receptors, and / or other electrical / hardware components that maybe integrated with or associated with a liner of a prosthetic system and used for many purposes including, for example, diagnostics, therapies, comfort, fit, etc.) and one or more external components (for example, electronic circuitry which may include a signal / power- supply and / or control system) with little or no need for liner-embedded wiring. The devices, systems, and method hereof enable transmission of electrical signals (for example, at least one of power and data) to conductive elements of the flexible liner from the exterior of a prosthetic socket worn over the liner. Any wires used in the devices, systems, and methods may be used in connection with the outer, solid, socket where such wires may be readily protected from bending and stretching. Various embodiments hereof are discussed in association with representative conductive connections for vibrational motors embedded in a prosthetic flexible liner. One skilled in the art will appreciate, however, that the devices, systems, and methods hereof may be used to communicate electrical signals for electrical power and / or data with any type of electronic component integrated with or associated with (that is, in electrical connection with) a flexible liner.

[0059] In a number of embodiments, the devices or system hereof are advantageously integrated into a prosthetic system 10 including a soft / flexible prosthetic interface or liner 20 and a relatively hard / rigid exterior shell or socket 80. FIGS. 1 through 3, illustrated a conventional prosthesis flexible liner 20 in connection with a prosthetic socket 80. Soft or flexible liners 20 are worn inside an outer shell in the form of rigid outer socket 80 by many people with upper or lower limb loss. Flexible liner 20 provides a soft, flexible interface for the user over at least a portion of outer socket 80. Full contact of such outer sockets 80 with the residual limb 5, along with a suspension mechanism (for example, a pin 40 and cooperating lock 90 system) provides for a reliable and comfortable connection between the limb and the prosthesis. As described in U. S. Patent No. 11,577,045, the disclosure of which is incorporated herein by reference, vibrators such as small vibration motors 70 may, for example, be installed in liner 20 without affecting the overall thickness of liner 20, and without substantially affecting flexibility and elasticity or flexibility of liner 20 (see, for example, FIGS. 4 and 5) to provide vibration therapy in a number of embodiments hereof.

[0060] In that regard, one or more vibrators 70 may be placed in connection with (for example, embedded within a flexible, elastic polymeric layer) flexible interface or liner 20. Such vibrators 70 may, for example, be positioned so that at least a portion of the flexible interface or liner 20 is positioned between the one or more vibrators 70 and the residual limb when prosthetic system or device 10 is worn by the user / patient. Vibrators 70 may, for example, have a low profile to reduce or minimize the thickness of flexible liner 20. Ingeneral, liners for prosthetics come in different wall thicknesses. Most commonly, the liner thickness is between approximately 3 and approximately 6 mm. However, there are indications for thinner liners as well (2mm or even 1mm). There are also tapered or progressive profiles. The build height of vibrational devices / motors inevitably limits how thin the liner wall can be without parts of the hardware protruding and interfering with socket fit, particularly when at least partially embedded within the liner. Vibrational motors or other vibrational mechanisms / devices for use in connection with flexible liners may be custom fabricated or commercially available. The size / build height of such vibrational devices is correlated with their performance. Because of decreased output of vibrational energy being associated with vibrational devices of smaller dimension, a plurality of or an array of small vibrational device may be provided to achieve the same effect as a single, larger vibrational device given limitations on liner thickness and corresponding limitations on the height of the vibratory devices.

[0061] Electronic circuitry 100 includes, for example, a power supply 110 and may include a controller or control system (for example, including a processor system having one or more processors such as a microprocessor 120 and an associated memory system 130). Electronic circuitry 100 may further include a wired or wireless (for example, BLUETOOTH) antenna or transceiver 140. Electronic circuitry may include other elements such as a user interface system, and input / output system, an alarm system, etc. as known in the electrical and computer arts. Electronic circuitry 100 may, for example, be housed in a small housing unit 150 outside of the liner 20 (see, for example, FIG. 5) to, for example, provide power and / or data transfer to electronic components operatively connected to or integrated with flexible liner 20 such as vibrators 70. Housing unit or housing 150 may, for example, be attached to the outer side of the outer shell or rigid socket 80 as further described below. Housing 150 may, for example, include one or more controls such as a toggle switch 160 to manually activate vibration motors 70 (see FIG. 5).

[0062] In a number of embodiments, the user may turn the device on and off as described above. The device may additionally or alternatively be activated in an automated fashion. One or more software algorithms may control the timing and duration of use (for example, via a app of a smartphone or other device which may be in communication with electronic circuitry 100). The user may, for example, be instructed to use the device as needed, turning it on, for example, when they experience phantom limb pain. The vibrations may be set to turn off at a preestablished time. If the user desires continued stimulation, the user may reinitiate a sequence.

[0063] One or more sensors of a sensor system 300 (illustrated schematically in FIG. 5) may provide data / information to circuitry 100. For example, sensor system 300 may provide data to enable more autonomous control and / or improve performance of vibrators 70. Although it is difficult to measure pain or to predict the onset thereof, certain parameters may be measured to ensure suitable or optimized operation of the devices, systems and / or methods hereof and / or be relatable to the onset or severity of pain for a particular patient or a group of patients. A sensor to detect motion or activity such as an accelerometer may be used in controlling activation of one or more vibrators 70 to address resting pain and / or pain related to motion. For example, one or more vibrators 70 may be activated after a certain period of rest or inactivity. That period and / or other control parameters (whether based on sensor measurement or otherwise) may, for example, be adjustable by the user or a clinician via, for example, a BLUETOOTH and / or other communication protocol (in at least one of a wireless or a wired manner). Other sensors such as temperature sensors, heartrate sensors, perfusion sensors, perspiration sensors, etc. may be used in determining a physical state of the user as well as user parameters in activating or controlling the operational parameters (for example, frequency, magnitude, timing etc.) of one or more vibrators 70 hereof.Further, one or more sensors may be provided to measure the operation of the devices, systems, and methods hereof. For example, one or more pressure sensors may be provided to ensure that liner 20 is suitably engaged with or contacting the user's body. Likewise, one or more vibration sensors may be used to ensure suitable operation of one or more vibrators 70 hereof. One or more sensors of sensor system 300 may, for example, be used in feedback or other control algorithms of the systems, devices and / or methods hereof.

[0064] In a number of embodiments, control of the vibration function by the user may be achieved, at least in part, through communication with one or more other devices such as a computer, a server, or a personal communication device 200 (illustrated schematically in FIG. 5), which may, for example, provide for the setting or definition of different activation patterns and schedules. As used herein, the term "personal communication device" refers generally to mobile devices which include a communication system, a processor system, one or more user interfaces (for example, a visual feedback system including a touchscreen or other display, an auditory feedback system, and / or a tactile feedback system etc.) and an operating system capable of running general-purpose applications. Examples of personal communications devices include, but are not limited to, smartphones, tablet computers and custom devices. As used herein, the term "tablet computer" or tablet, refers to a mobile computer with a communication system, a processor system, at least one user interface asdescribed above (typically including a touchscreen display), and an operating system (for example, an ANDROID® or iOS® operating system) capable of running general-purpose and specially developed custom applications in a single unit. As used herein, the term "smartphone" refers to a cellular telephone including a processor system, at least one user interface as described above (typically including a touchscreen display), and an operating system capable of running general-purpose and specially developed custom applications. Such personal communication devices are typically powered by rechargeable batteries and are housed as a single, mobile unit. A number of representative embodiments of systems and methods hereof may, for example, include a smartphone with customized user interface software to form at least a portion of the control system.

[0065] In the systems described in U. S. Patent No. 11,577,045, electrically conductive wires or load wires were used for connection of external electronic circuitry to vibration motors embedded in a flexible to external electronic circuitry. Such wires were embedded within the flexible liner thereof and followed a meandering path through the flexible liner to accommodate stretch. As described above, such wires are still susceptible to damage from being bent or stretched with the liner wall and may interfere with the regular donning and doffing of the liner.

[0066] FIGS. 6 through 9B illustrate a representative embodiment of a system 10a (see, FIGS. 6 and 9B) and portions thereof, wherein prosthetic socket 80 of system 10a includes a prosthesis-compatible, conductive connection system 400a (see FIGS. 8, 9A and 9B). In certain embodiments, conductive connection system 400a is, for example, well adapted to be added to or retrofitted upon existing prosthetic sockets. Conductive connection system 400a, or simply connection system 400a, is functional to transmit electrical signals (including, for example, electrical power, data, etc.) from external electronic circuitry 100 to one or more electronic components associated with flexible liner 20a (for example, positioned interior to flexible liner 20a, integrated within flexible liner 20a, or otherwise in operative / electrical connection with flexible liner 20a) when prosthetic socket is donned over flexible liner 20a of system 10a.

[0067] In a number of representative embodiments hereof, connection system 400a of system 10a is illustrated in connection with a representative embodiment of a vibration therapy system as described above. In that regard, in a number of embodiments, a modified silicone prosthesis liner 20 includes one or more embedded vibration motors 70. In a number of studied embodiments, vibrators 70 were embedded between a silicone layer and fabric layers of an off-the-shelf liner and sealed with silicone epoxy. Prosthetic socket 80may, for example, be placed in connection with a detachable housing 150 for electronic circuitry 100 as described above. Electronic circuitry 100 is, for example, configured to provide electrical energy to vibrators 70 via connection system 400a to power vibrators 70. In the illustrated embodiment, connection system 400a includes two extending conductors 410a and 410a' (for example, strips or lengths of conductive copper tape in a number of embodiments) which are placed in electrical connection with a negative load wire 420a and a positive load wire 420a', respectively. Load wires 420a and 420a' are in electrical connection with power supply 110 (see, for example, FIG. 9C) of electronic circuitry 100. In a number of embodiments, a single pad or contact member may be divided into multiple, electrically isolated contacts such that a single pad or contact member may provide multiple, electrically isolated conductive pathways. In the illustrated embodiment, load wires 420a and 420a' terminate in contacts or pads 422a and 422a' which cooperate with (or are placed in electrical connection with) contacts or pads 412a and 412a' which are in electrical connection with extending conductor 410a and extending conductor 410a', respectively, to pass current from electronic circuitry 100 to vibrators 70. In a number of embodiments, contacts 422a and 422a' as well as contacts 412a and 412a' were connectors capable of forming a cooperating physical connection or attachment as well as electrical contact or connection. In a number of studied embodiments, contacts 422a and 422a' and cooperating contacts 412a and 412a' were cooperating conductive hook-and-loop type connectors. Other cooperating conductive connections (including, for example, using other physical connectors, magnetic connections, etc.) may be used in connection with electrical contacts hereof.

[0068] The wires (illustrated as broken lines in FIG. 7) of vibrators / vibrational motors 70 terminate under (and in electrical connection with) conductive contacts or pads 72 which were embedded between the silicone and fabric layers of liner 20. In a number of studied embodiments hereof, wires extending between vibrators 70 and contacts 72 were kept as short as possible with the goal of making them less affected by stretching of liner 20. Additionally, maintaining the direction of such wires as horizontal as possible (in the orientation of, for example, FIG. 7 or in a plane perpendicular to the axis of liner 20) with the goal of minimizing or preventing bending of such wires during rolling. Such wires may be eliminated completely by forming contacts 72 integrally with electrical components such as vibrators 70. In that regard, each electrical component of liner 70 may include its own contacts to receive power (and / or to transmit data). Whether such electrical components are powered in series electrical connection or parallel electrical connection may becontrolled via the design of the conductive connection system of the prosthetic socket. Connecting electrical components such as vibrators 70 in parallel enables independent control / powering.

[0069] In a number of embodiments, contacts 72 were also connectors capable of forming a physical connection or attachment as well as an electrical contact or connection with a cooperating conductive connector. For example, conductive hook-and-loop type connectors, contacts, or pads were used in a number of studied embodiments. Other types of connectors may be used to form a physical connection as known in the electrical arts. The outer or radially outer surface of such connectors when connected to liner 70 may desirably be sufficiently smooth to enable a sliding connection to be made between contacts / connectors 72 and conductors 410a and 410a' as described further below. Alternatively, separate contacts may be provided for forming (i) a sliding electrical contact / connection, and (ii) a physical and electrical connection. As, for example, illustrated in FIG. 9C, housing 150 in a number of studied embodiments include power supply 110 (for example, a lithium polymer battery), a mini-USB charging board 112 for the battery, on / off switch 160. One end of the load wires 420a and 420a' connected to charging board 112 within housing 150, and the other end of load wires 420a and 420a' terminated at conductive (hook-and-loop type) contacts or pads 422a and 422a', respectively.

[0070] Each of spaced extending conductors 410a and 410a' (copper tape in the studied embodiments) is affixed to the exterior surface socket 80, extends upward, extends / wraps over the top edge of socket 80, and extends over (and is affixed to) an interior surface of socket 80. Extending conductors 410a and 410a' extend down the interior of socket 80 a sufficient distance to align with and make electrical contact with contact or pads 72 on flexible liner 20 when socket 80 is donned, thereby acting as electrical contacts for conductive contacts or pads 72. Two spaced / electrically isolated lengths of extending conductors 410a and 410a' were used to provide one conductor for contact with negative wires and one conductor for the positive wires. Although two conductive contacts 72 and two conductors or extending conductors 410a are illustrated in the embodiment of FIGS. 6 through 9C, one skilled in the art will appreciate that multiple pairs of cooperating conductors can be provided. Moreover, a single conductive contact may be suitable to, for example, transmit data via electrical signals.

[0071] In a number of studied embodiments, cooperating connectors 412a and 412a' were conductive hook-and-loop connectors which were glued onto each length of extending conductors 410a and 410a'. Housing 150 for electronic circuitry 100 can, for example, beattached to the exterior surface of socket 80 with standard hook-and-loop type fasteners 82 (see FIGS. 6, 8, and 9A) to be readily attachable and detachable. Upon attaching housing 150 to socket 80, load wires 420a and 420a' can be electrically connected to cooperating connectors, contacts, or pads 412a and 412a' via conductive connectors, contacts, or pads 422a and 422a' (for example, conductive hook-and-loop type connectors) to place electronic circuitry 100 in electrical connection with extending conductors 410a and 410a'.

[0072] FIG. 10 illustrates a portion of another embodiment of a system 10b hereof which functions in essentially the same manner as system 10a. Unlike system 10a however, extending conductive conductors 410ab and 410ab' (for example, conductive wires) are embedded within or pass through socket 80 to provide a conductive pathway between conductive connectors or pads 422a and 422a' on an exterior of wall of socket 80 and conductive contacts 414ab and 414ab' on an interior wall of socket 80. In system 10b, the combination of extending conductive conductors 410ab and 410ab' and conductive contacts 414ab and 414ab' provides the function of extending conductive conductors 410a and 410a' of system 10a to pass an electrical signal from the exterior wall of socket 89 to the interior wall thereof. In the embodiment of FIG. 10, like the embodiment of FIGS 6 through 9C, the conductive contacts on the inner surface of the socket are placed in electrical connection with the conductive contacts on the outer surface in a manner such that no extending electrical conductors therebetween (which conduct electrical signals from the outside of the socket to the inside of the socket) are spaced from any surface of the prosthetic socket, thereby minimizing the risk of damage.

[0073] During donning of socket 80 over flexible liner 20 (as worn by the user, see, for example, FIGS. 11 and 12), extending conductors 410a and 410a' (two pairs of extending conductors 410a and 410a' are provided as illustrated in FIG. 11) or contacts 410ab and 410ab' (as described above in connection with FIG. 10) are brought into electrical contact with conductive connectors, contacts or pads 72 to provide a conductive pathway between cooperating connectors 412a and 412a' and vibrators 70. One or both of the contacts on the inner surface of socket 80 (for example, extending conductors 410a and 410a' or contacts 410ab and 410ab') or cooperating contacts on the surface of liner 20 (for example, contacts 72) desirably has a sufficient surface area such that contact is achieved regardless of changes in relative position of liner 20 and socket 80 that arise during repeated donning thereof over time. Such changes in relative position may, for example, most often occur along axis A as illustrated in FIG. 9A or rotationally about axis A as represented by curved, double-ended arrow R in FIG. 9A. The electrical connection between the liner electrical components andsocket electrical components is made on contact during donning of the socket 80 over the liner 20. Contacts 72 and extending conductors / contacts 410a and 410a' (or contacts 410ab and 410ab') are formed such that they may slide over each other and slide into electrical connection during donning of socket 80 over liner 20. In that regard, if contacts 72 are conductive hook-and-loop type connectors, extending conductors / contacts 410a and 410a' (or contacts 410ab and 410ab') are smooth in conformation to enable such relative sliding motion. In a number of embodiments, there are no plugs that need to be aligned and connected before use of the electrical components of the system. In FIG. 11, a bandage wrap B is wrapped around a bottom or distal portion of socket 80.

[0074] As known in the prosthesis arts, liners such as liners 20 are flexible / compressible. While liners are somewhat rotation-symmetrical, they do not include a design feature that facilitates consistent alignment, as is the case for a residual limb. The devices, systems, and methods hereof are suitable to achieve consistent electrical connections during donning and to withstand the repeated bending and stretching of the liner that is inevitable during donning and doffing, as well as regular wearing of the liner. The devices, systems, and method hereof allow for variations in doffing that are expected in typical use by prosthesis users. For example, cooperating conductive connectors may have a sufficient surface area to ensure alignment and contact regardless of normal variations in doffing. Moreover, the devices, systems, and methods hereof are also unaffected by moisture or contaminants that can occur in typical prosthesis use.

[0075] When socket 80 is donned over flexible liner 20 (as worn by the user, see, for example, FIGS. 11 and 12), vibrators 70 (for example, vibration motors) may be manually actuated / operated via switch 160. For example, a user may place switch 160 in an on state to provide electrical energy to vibrators 70 embedded in liner 20 to provide vibration therapy. Various software-implemented programs for specific therapies may also be used as described above.

[0076] Alternatively, vibration, other therapy, or any other use in which electrical signals are transmitted can occur independent of socket 80. Contacts 72 on liner 20 may be directly connected to contacts 422a and 422a' (for example, which may be formed as cooperating conductive hook-and-loop type connectors) on wires 420a and 420a' in electrical connection with electronic circuitry 100 within electronics housing 150 as illustrated in FIG. 12. This functionality allows the user to doff socket 80, detach housing 150 from socket 80, and attach connectors 422a and 422a' of load wires 420a and 420a' directly to contacts 70 on liner 20 to provide the vibration therapy.

[0077] FIGS. 13A through 13C illustrate an embodiment of a conductive wrap 500 hereof. Conductive wrap 500 may, for example, be wrapped around flexible liner 20b (as illustrated in FIGS. 13B and 13C) and attached / closed via, for example, cooperating hook-and-loop type connectors as known in the connection art. In the illustrated embodiment, conductive nylon tape was used to create multiple contacts 510 to, for example, power multiple vibrators (and / or other electronic components) by wrapping conductive wrap 500 around liner 20b so that each of contacts 510 forms an electrical connection with one or more contacts (not shown but similar to contacts 72) for the vibrators. In that regard, conductive wrap 500 includes one or more first conductive connectors or contacts on an inner surface to form a connection with contacts on an outer surface of liner 20b. Conductive wrap 500 further includes one or more second conductive contacts to form an electrical connection with electronic circuitry 100 within electronic circuitry housing 150 (see, for example, FIG. 13A). In the illustrated embodiment, two contacts 510 are formed. One skilled in the art will appreciate that more than two such contacts may be provided on a conductive wrap hereof. Conductive wrap 500 was constructed with adhesive conductive nylon tape contacts 510 adhered to a strip of felt 520. Additional felt strips 522 were glued vertically over the seams in the conductive nylon tape to protect such from peeling or separating. Felt strip 520 was glued onto a strip of hook-and-loop type connector material 530 which formed the outer surface of conductive wrap 500 so the conductive wrap 500 can be secured around liner 20b. The top strip of the conductive nylon tape is placed in contact with wire 540a, and the bottom strip of conductive nylon tape is in contact with wire 540b. Wires 540a and 540b are in connection with JST-PH receiver / connector 550a that mates with a cooperating JST-PH connector 550b connected to wires extending from electronic circuitry housing 150. The same type of JST-PH receiver / connector can, for example, be soldered to conductive tape extending conductors 410a and 410a' on socket 80 as an alternative to conductive hook- and-loop type connectors 412a and 412a'. Housing 150 having wires equipped with JST-PH connector 550b may be placed in electrical connection with socket 80 (as described above) when socket 80 is donned over liner 20b.

[0078] Studies discussed below, indicate that wraps such as wrap 500 may benefit from facilitating alignment of the conductors of the wrap and contacts of the liner. Such wraps may, for example, be readily designed to allow for even greater deviation and misalignment during set up. Moreover, the conical shape of the residual limb of a transfemoral amputee may cause the wrap to tend to slide toward the distal end of the users residual limb during use, resulting in loss of electrical contact. In facilitating initial alignment and maintainingalignment during use, one may, for example, include one or more elements such as connectors (for example, cooperating hook-and-loop type elements, etc.) to secure the conductive wrap to the conductive hook-and-loop contacts in a manner to indicate to the user that the connection has been made successfully and to prevent the conductive wrap from sliding during use.

[0079] Further providing a wrap such as conductive wrap 500 which encompasses a portion of or the entirety of the circumference of liner 20b may be used to alter the pressure on vibrational components such as vibrational motors associated with liner 20b. Altering the pressure on the vibrational components may be used to alter the sensatory experience of the user. For example, making the fit of conductive wrap 500 tighter, thereby applying increased pressure to vibrational components, may provide a feeling of stronger vibration, while loosening the fit of conductive wrap 500 may provide a feeling of less strong or weaker vibration.

[0080] Representative Examples

[0081] In a number of studied embodiment hereof (see FIGS. 14A through 14C), studied flexible liners 20c included two posterior motors 70c located three centimeters from the distal end of the femur and four pairs of motors 70c located eight to ten centimeters above the distal end of the femur and evenly spaced circumferentially around flexible liner 20c. Motors 70c were micro vibrating motors with a diameter of 10 mm, a thickness of 3 mm, and a rated DC voltage range of 2.5-3.8 volts. At the rated voltage, the rotational speed of motors 70c was 11,000 ± 3000 rpm, which equates to a frequency range of 183 ± 50 Hz. The associated wires were (not shown) pulled through a channel tunneled through a silicone layer of flexible liner 20c, and two motors 70c were paired with their wires terminating under a pair of conductive hook-and-loop conductive contacts or pads 72c as described above. Conductive hook-and-loop pads 72c served as contact points for making the electrical connection with electronic circuitrylOO (enclosed within housing 150, see FIGS. 13A and 14B) when electronic circuitry 100 was used directly with flexible liner 20c as described above. Motors 70c were embedded in a four-millimeter-deep hole cut into the silicone and sealed with Sil-poxy. That method did not create noticeable, raised bumps on the surface of flexible liner 20c and protected the wires underneath the fabric layer during donning and doffing. The hole cut for the motors did not puncture through to the inside of flexible liner 20c, so the silicone that interfaced with the skin remained intact..

[0082] Since maintaining suction within the socket may be a design criterion in certain embodiments, the method of making an electrical connection between prostheticsocket 80c (see FIGS. 14B and 14C) and flexible liner 20c should not interfere with the air- tight seal in such embodiments. Prosthetic socket 80c may be placed in connection with a detachable housing 150 (see FIGS. 14B and 14C) for electronic circuitry 100 as described above. Electronic circuitry 100 was, for example, configured to provide electrical energy to vibrating motors 70c via connection system 400c to power vibrators 70. In that regard, and as further described below, connection system 400c of socket 80c included an arrangement of copper tape on the exterior and interior surfaces of socket 80c, wherein the inner copper tape aligned with conductive hook-and-loop contacts 72c on flexible liner 20c upon donning as, for example, described in connection with FIGS. 7 through 9C.

[0083] In that regard, connection system 400c includes two extending conductors 410c and 410c' (lengths of conductive copper tape in the studied embodiments) which are placed in electrical connection with a negative load wire and a positive load wire, respectively. The load wires are in electrical connection with power supply 110 (see, for example, FIG. 9C; three AA batteries in the studied embodiments) of electronic circuitry 100 within housing 150.

[0084] Each of spaced extending conductors 410c and 410c' was affixed to the exterior surface socket 80c, extended over the top edge of socket 80c, and extended over (and was affixed to) an interior surface of socket 80c. Extending conductors 410c and 410c' extend down the interior of socket 80c. In the studied embodiment, each extending conductors 410c and 410c' was connected to a generally circumferentially extending conductor 411c and 411c', respectively, which were formed from conductive, copper tape. Circumferentially extending conductors 411c and 411c' are in electrical connection with contacts 422c and 422c' around the circumference thereof, which were formed from conductive copper tape, and have an enlarged area to facilitate alignment and electrical contact with conductive contacts or pads 72c on flexible liner 20c when socket 80c is donned thereover. Electrically isolated conductors 410c and 410c', circumferentially extending conductors 411c and 411c', and contacts 422c and 422c' were used to provide one conductive path for contact with negative connections of vibrating motors 70c and another conductive path for contact with positive connections of vibrating motors 70c.

[0085] On the outside of socket 80c, a pair of wires attached to a JST-PH connector 450c(available from, from J.S.T. Mfg. Co. of Waukegan, Illinois US), which was configured to be placed in electrical connection with electronic circuitry 100. The wires were soldered to the conductive tape of extending conductors 410c and 410c'. Housing 150 for electronic circuitry 100 mated the JST-PH connector 450c and was affixed to socket 80c with cooperatingVELCRO hook-and-loop type connectors. Electronic circuitry 100 included an on / off switch as describe above.

[0086] To use flexible liner 20c without donning socket 80, a conductive wrap was constructed with felt, Velcro, and copper tape as illustrated in FIGS. 13A through 13C. The wrap included a JST-PH connector which connected to electronic circuitry 100.

[0087] The average lifespan of a conventional prosthesis liner is six months. Assuming the liner is donned and doffed once per day, it undergoes approximately 400 donning and doffing cycles during its lifespan. The robustness of the prototype, particularly the method of embedding the motors and wires, was assessed by simulating 400 donning and doffing cycles on a plaster mold. Throughout the testing process, the liner was inspected for tears in the silicone, loosening of motors, and any other changes to the prototype. After every 50 cycles, the embedded motors were tested for functionality.

[0088] The prototype was also studied with a number of human study participants. It is necessary to routinely clean the liner since it contacts the skin. Throughout the construction process and before each participant tested the prototype, the liners were cleaned with a pH- neutral prosthetic cleanser and observed for any damage to the liner or added components.

[0089] The participants reported cleaning their sockets less frequently than their liners, so a benchmark of 35 cycles was chosen, assuming the socket is cleaned roughly once or twice a week over about six months. When cleaning the socket, three combinations of cleaning materials were tested to simulate the conditions the participants reported and to test a third, more abrasive, condition. All combinations used dish soap and water, but one combination used a cloth alone (SC), a second used a cloth and included wiping down the socket with isopropyl alcohol after washing (SAC), and a third used a scrub brush in addition to wiping down the socket with isopropyl alcohol after washing (SAB).

[0090] Participants provided feedback to validate the prototypes and completed a trial with the prototypes to study the effects of vibration therapy on phantom limb pain or PLP when administered via a vibration liner. Participant feedback and an assessment of contact between the liner and socket were used to evaluate the socket's fit. To assess whether the suction of the check socket was maintained, a test was performed wherein the participant donned the socket over the prototype liner and attempted to pull their residual limb out of the socket while a researcher held the socket steady. During a four-week trial, participants were instructed to use the vibration liner in the event of PLP. Participants were asked to use the liner only when sitting or lying down to comply with an approved study protocol. They were also asked to record the date, start time, and end time of using the liner and rate theirpain intensity before and after using the liner on the 11-point Numeric Pain Rating Scale, where 0 indicates no pain and 10 indicates the worst pain imaginable. A one-tailed paired sample t-test (α = 0.05) was used to compare pain intensity before and after using the vibration liner and determine whether to reject the null hypothesis. Qualitative feedback was collected during an interview process including pre-written questions aimed at obtaining feedback on three primary themes: the usability and design of the vibration liner, the effect of vibration therapy on PLP, and the effect of vibration therapy on PLS. Responses were transcribed during each interview. Following the interviews, the transcriptions were reviewed for commonalities related to the primary themes.

[0091] After 70 cycles of donning and doffing, the conductive hook-and-loop contacts 72c showed no signs of wear and remained securely embedded in liner20c. Motors 70c were tested for functionality and passed each time.

[0092] The liners were cleaned with a pH-neutral prosthetic cleanser according to the instructions from the cleanser manufacturer, and no damage was observed. After 35 cycles, the SC and SAC trials resulted in no tearing and minimal peeling of the conductive copper tape strips, and the SAB trials resulted in a similar degree of peeling and slight tearing of the copper tape strips. The copper tape strips from all trials were functional when tested after the cleaning protocols.

[0093] Two individuals with transfemoral limb loss participated in a data collection study. The elements added to the liners and sockets to create the prototypes did not affect the fit or suspension of the sockets. The participants indicated that the sockets fit comfortably, and the vibration motors were not causing discomfort through the liner. The participants did not notice the motors being pressed against their skin. After donning the vibration liner and the socket, the gray band around the liner, used for vacuum seal, had no wrinkles or ripples, indicating that it was making good contact with the socket. Additionally, each participant's residual limb evenly contacted the socket to the same degree as before the modifications. The suspension continued working as intended, with each participant unable to pull their residual limb out of the socket when tested.

[0094] During the four-week trial, the participants reported a reduction in pain intensity after using the vibration liner. One participant experienced PLP once throughout the four weeks, and another participant experienced PLP an average of three times per week. Before using the vibration liner, the participant's reported pain intensity ranged between 3 and 6 (mean 4.33) with an outlier at 2. The median pain level was 4.5 (IQR 4-5). After using the vibration liner, the participant's reported pain intensity ranged between 0 and 1 (mean0.75). The median pain level was 1 (IQR 0.25-1). Statistical comparison of the pre- and post- vibration pain level on the latter participant's data indicated a significant (p < 0.001) improvement of the average pain intensity from 4.33 to 0.750 on an 11-point scale.

[0095] The participants provided qualitative feedback on vibration therapy and the vibration liner prototype. Their feedback validated that the embedded vibration motors and electrical contacts did not irritate their skin or interfere with rolling the liner to don and doff it. Having vibration applied to the residual limb was described as relaxing and soothing. The vibration provided stimulation to the muscles and nerves of the residual limb. One participant also described a relaxation of his phantom limb sensation or PLS. Participants expressed experiencing pain relief from the vibration liner. The feeling of PLP when using the vibration liner was described as dulled and numbed. The participants indicated some difficulty aligning the contacts and maintaining contact with the wrap (see FIGS. 13A through 13C.)

[0096] The results of the bench testing and clinical testing demonstrated that the method of embedding motors and wires was a feasible method to withstand the average six-month lifespan of prosthetic liners and cleaning the liner with a prosthetic-safe cleanser. While the Sil-Poxy covering one motor wore through and exposed the motor during the bench test, this was likely due to that layer of Sil-Poxy being initially thin. For motors that were covered with a thicker layer of Sil-Poxy during the bench test, no wear to the Sil-Poxy was observed. Moreover, the motors remained securely embedded in the liner. Applying a thicker layer of Sil-Poxy when embedding the motors in the liner could address the wear seen with the one motor. Motors in subsequent prototypes were covered with a thicker layer of Sil-Poxy, and no wear or tearing was observed. The thicker covering of Sil-Poxy on the exterior of the liner did not affect the comfort or ease of use of the liner, as the participants indicated the prototype liners were comfortable and no more difficult to don and doff compared to their personal liners. Cleaning the socket and liner was unaffected by the addition of the prototype elements, including the electrically conductive contact system hereof. An abrasive cleaning method, such as using a bristle brush, may result in some peeling and tearing of the conductive copper tape, but the participants' current socket cleaning methods would cause only minimal peeling at the edges of the copper tape. The adhesion and functionality of the copper tape remained unaffected. A waterproof adhesive can be added over the copper tape on the inside of the socket to reduce the wear to it from cleaning. Participant feedback confirmed that the liner and socket were comfortable, and the prototype components did not interfere with the suspension inside the socket.

[0097] The foregoing description and accompanying drawings set forth a number of representative embodiments at the present time. Various modifications, additions and alternative designs will, of course, become apparent to those skilled in the art in light of the foregoing teachings without departing from the scope hereof, which is indicated by the following claims rather than by the foregoing description. All changes and variations that fall within the meaning and range of equivalency of the claims are to be embraced within their scope.

Claims

Claims1. A prosthetic system, comprising: a flexible liner configured to conform to a residual limb of a user, one or more liner conductive contacts attached to the outer surface of the flexible liner, each of the one or more liner conductive contact being configured to be placed in electrical connection with at least one of one or more electronic components, and a prosthetic socket which is more rigid than the flexible liner, an inner surface of the prosthetic socket conforming to a shape of the flexible liner when the flexible liner is donned by the user such that the prosthetic socket is configured to be donned over the flexible liner when the flexible liner is donned, one or more socket inner conductive contacts attached to the inner surface of the prosthetic socket, each of the one or more socket inner conductive contacts being positioned on the inner surface of the prosthetic socket and being configured to move into electrical contact with at least one of the one or more liner conductive contacts during donning of the prosthetic socket over the flexible liner, each of the one or more socket inner conductive contacts being in electrical connection with at least one of one or more socket outer conductive contacts attached to an outer surface of the prosthetic socket.

2. The prosthetic system of claim 1 wherein each of the one or more socket inner conductive contacts is in electrical connection with at least one of the one or more socket outer conductive contacts in a manner that no extending electrical conductors therebetween are spaced from any surface of the prosthetic socket.

3. The prosthetic system of claim 2 wherein, before the prosthetic socket is donned thereover, each of the one or more liner conductive contacts is electrically isolated from one or more others of the liner conductive contacts when there are more than one liner conductive contacts.

4. The prosthetic system of claim 2 wherein each of the one or more socket inner conductive contacts is electrically isolated from one or more others of the socket inner conductive contacts when there are more than one socket inner conductive contacts.

5. The prosthetic system of claims 2 wherein each of the one or more socket outer conductive contacts are electrically isolated from one or more others of the socket outer conductive contacts when there are more than one socket outer conductive contacts.

6. The prosthetic system of claim 2 wherein each of the one or more socket inner conductive contacts is in electrical connection with at least one of the one or more socket outer conductive contact via an extending conductor (i) which extends over and is in contact withthe inner surface of the prosthetic socket, an upper rim of the prosthetic socket, and an outer surface of the prosthetic socket to be in electrical connection with a different one of the one or more socket outer conductive contacts or (ii) which extends through a wall of the prosthetic socket to be in electrical connection with a different one of the one or more socket outer conductive contacts.

7. The prosthetic system of any one of claims 1 through 6 further comprising electronic circuitry, the electronic circuitry being in electrical connection with one or more electronic circuitry contacts, each of the one or more electronic circuitry contacts being configured to from an electrical connection with a different one of the one or more socket outer conductive contacts or with a different one of the one or more liner conductive contacts, the electronic circuity being configured to at least one of (i) transmit electrical signals to the one or more electronic circuitry contact and (ii) receive electrical signals via the one or more electronic circuitry contacts.

8. The prosthetic system of claim 7 wherein each of the one or more electronic circuitry contacts is further configured to form a physical attachment with a different one of the one or more socket outer conductive contacts or with a different one of the one or more liner conductive contacts.

9. The prosthetic system of claim 8 wherein each of the one or more electronic circuitry contacts comprises a conductive hook-and-loop type connector, each of the one or more socket outer conductive contacts comprises a cooperating hook-and-loop type connector, and each of the one or more liner conductive contacts comprises a cooperating hook-and- loop type connector.

10. The prosthetic system of claim 7 wherein the flexible liner comprises two or more liner conductive contacts to provide electrical power to the one or more electronic components from the electronic circuitry.

11. The prosthetic system of claim 10 wherein the one or more electronic components comprise one or more vibrators.

12. The prosthetic system of claim 11 wherein the one or more vibrators are incorporated within a flexible, elastomeric polymeric material of the flexible liner.

13. The prosthetic system of claim 11 wherein the one or more vibrators comprise one or more vibrational motors.

14. The prosthetic system of claim 7 wherein the electronic circuitry comprises a processor system, a memory system in communicative connection with the processor system, and a power system in electrical connection with the processor system and the memory system,the memory system having one or more algorithms stored therein which are executable by the processor system.

15. The prosthetic system of claim 14 wherein the one or more algorithms are executable by the processor system to achieve at least one of (i) control electrical signals transmitted to the one or more electronic circuitry contacts and (ii) process electrical signals received from the one or more electronic circuitry contacts.

16. The prosthetic system of claim 14 wherein the electrical signals comprise at least one of a power signal and a data signal.

17. The prosthetic system of claim 16 wherein the one or more socket outer conductive contacts comprise a positive load outer socket and a negative load outer socket.

18. The prosthetic system of claim 15 wherein the electronic circuitry is contained within a housing.

19. The prosthetic system of claim 18 wherein the housing comprises one or more connectors configured thereon to connect to one or more cooperating connectors on the prosthetic socket.

20. The prosthetic system of claim 19 wherein the one or more connectors of the housing are hook-and-loop type connectors and the one or more cooperating connectors of the prosthetic socket are cooperating hook-and-loop type connectors.

21. The prosthetic system of claim 7 further comprising a flexible wrap configured to be placed in connection with the flexible liner when the flexible liner is worn by the user without the prosthetic socket, the flexible wrap comprising one or more first conductive contacts configured to be placed in electrical connection with the one or more liner conductive contacts attached to the outer surface of the flexible liner and one or more second conductive contacts configured to be placed in electrical connection with the electronic circuitry.

22. The prosthetic system of claim 11 further comprising a flexible wrap configured to be placed in connection with the flexible liner when the flexible liner is worn by the user without the prosthetic socket, the flexible wrap comprising one or more first conductive contacts configured to be placed in electrical connection with the one or more liner conductive contacts attached to the outer surface of the flexible liner and one or more second conductive contacts configured to be placed in electrical connection with the electronic circuitry.

23. A method to provide electrical connection between one or more electronic components associated with a prosthetic system and electronic circuitry, comprising:providing a flexible liner configured to conform to a residual limb of a user, one or more liner conductive contacts being attached to the outer surface of the flexible liner, each of the one or more liner conductive contact being configured to be placed in electrical connection with at least one of the one or more electronic components, providing a prosthetic socket which is more rigid than the flexible liner, an inner surface of the prosthetic socket conforming to a shape of the flexible liner when the flexible liner is donned by the user such that the prosthetic socket is configured to be donned over the flexible liner, one or more socket inner conductive contacts being attached to the inner surface of the prosthetic socket, each of the one or more socket inner conductive contacts being positioned on the inner surface of the prosthetic socket and configured to move into electrical contact with at least one of the one or more liner conductive contacts during donning of the prosthetic socket over the flexible liner, each of the one or more socket inner conductive contacts being in electrical connection with at least one of one or more socket outer conductive contacts attached to an outer surface of the prosthetic socket, and providing the electronic circuitry, the electronic circuitry being in electrical connection with one or more electronic circuitry contacts, the electronic circuity being configured to at least one of (i) transmit the electrical signals to the one or more electronic circuitry contacts and (ii) receive electrical signals from the one or more electronic circuitry contacts, each of the one or more electronic circuitry contacts being configured to form an electrical connection with a different one of the one or more socket outer conductive contacts or with a different one of the one or more liner conductive contacts.

24. The method of claim 23 wherein each of the one or more electronic circuitry contacts forms an electrical connection with the different one of the one or more socket outer conductive contacts to be placed in electrical connection with the one or more electronic components via the one or more liner conductive contacts when the prosthetic socket is donned over the flexible liner being worn by the user or each of the one or more electronic circuitry contacts forms an electrical connection with a different one of the one or more liner conductive contacts to be placed in electrical connection with the one or more electronic components when the prosthetic socket is not donned over the flexible liner being worn by the user.

25. The method of claim 23 wherein each of the one or more socket inner conductive contacts is in electrical connection with at least one of one or more socket outer conductive contacts in a manner so that no extending electrical conductors therebetween are spaced from any surface of the prosthetic socket.

26. The method of claim 25 wherein, before the prosthetic socket is donned thereover, each of the one or more liner conductive contacts is electrically isolated from one or more others of the liner conductive contacts when there are more than one liner conductive contacts.

27. The method of claim 25 wherein each of the one or more socket inner conductive contacts is electrically isolated from one or more others of the socket inner conductive contacts when there are more than one socket inner conductive contacts.

28. The method of claim 25 wherein each of the one or more socket outer conductive contacts are electrically isolated from one or more others of the socket outer conductive contacts when there are more than one socket outer conductive contacts.

29. The method of claim 25 wherein each of the one or more socket inner conductive contacts is in electrical connection with at least one of the one or more socket outer conductive contacts via an extending conductor (i) which extends over and is in contact with the inner surface of the prosthetic socket, an upper rim of the prosthetic socket, and an outer surface of the prosthetic socket to be in electrical connection with a different one of the one or more socket outer conductive contacts or (ii) which extends through a wall of the prosthetic socket to be in electrical connection with a different one of the one or more socket outer conductive contacts.

30. The method of claim 24 wherein the one or more electronic components comprise one or more vibrators.

31. The method of claim 30 wherein the one or more vibrators are incorporated within a flexible, elastomeric polymeric material of the flexible liner.

32. The method of claim 30 wherein the one or more vibrators comprise one or more vibrational motors.

33. The method of claim 24 wherein the electronic circuitry comprises a processor system, a memory system in communicative connection with the processor system, and a power system in electrical connection with the processor system and the memory system, the memory system having one or more algorithms stored therein which are executable by the processor system.

34. The method of claim 33 wherein the one or more algorithms are executable by the processor system to at least one of control the electrical signals transmitted to the one or more electronic circuitry contacts and process electrical signals received from the one or more electronic circuitry contacts.

35. The method of claim 33 wherein the electrical signal comprise at least one of a power signal and a data signal.

36. The method of claim 23 further comprising providing a flexible wrap configured to be placed in connection with the flexible liner when the flexible liner is worn by the user without the prosthetic socket, the flexible wrap comprising one or more first conductive contacts configured to be placed in electrical connection with the one or more liner conductive contacts attached to the outer surface of the flexible liner and one or more second conductive contacts configured to be placed in electrical connection with the electronic circuitry.

37. A flexible liner for use with a prosthetic system including a prosthetic socket, the flexible liner being configured to conform to a residual limb of a user, comprising: one or more liner conductive contacts attached to the outer surface of the flexible liner, each of the one or more liner conductive contact being configured to be placed in electrical connection with at least one of one or more electronic components and to be placed in electrical connection with at least one of one or more liner conductive contacts during donning of the prosthetic socket over the flexible liner and, wherein the one or more liner conductive contacts are positioned on an interior surface of the prosthetic socket.

38. The flexible liner of claim 37 wherein, before the prosthetic socket is donned thereover, each of the one or more liner conductive contacts is electrically isolated from one or more others of the liner conductive contacts when there are more than one liner conductive contacts.

39. A prosthetic socket configured to be donned over a flexible liner of a prosthetic system worn by a user, the prosthetic socket being more rigid than the flexible liner, comprising, an inner surface conforming to a shape of the flexible liner when the flexible liner is donned by the user such that the prosthetic socket is configured to be donned over the flexible liner when the flexible liner is donned, one or more socket inner conductive contacts attached to the inner surface of the prosthetic socket, each of the one or more socket inner conductive contact being positioned on the inner surface of the prosthetic socket and being configured to move into electrical contact with at least one of one or more liner conductive contacts attached to an outer surface of the flexible liner during donning of the prosthetic socket over the flexible liner, each of the one or more socket inner conductive contacts being in electrical connection with at least one of one or more socket outer conductive contacts attached to an outer surface of the prosthetic socket.

40. The prosthetic socket of claim 39 wherein, before the prosthetic socket is donned thereover, each of the one or more liner conductive contacts is electrically isolated from one or moreothers of the liner conductive contacts when there are more than one liner conductive contacts.

41. The prosthetic socket of claim 39 wherein each of the one or more socket inner conductive contacts is electrically isolated from one or more others of the socket inner conductive contacts when there are more than one socket inner conductive contacts.

42. The prosthetic socket of claim 39 wherein each of the one or more socket outer conductive contacts are electrically isolated from one or more others of the socket outer conductive contacts when there are more than one socket outer conductive contacts.

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