Patent Description:
An ongoing challenge in the development of prosthetic devices is the attachment of the prosthetic device to the residual limb of a user. For prosthetic legs, it is often difficult to securely attach the prosthetic leg to the residual leg without exerting too much or uneven pressure on the residual limb. On the one hand, the lack of a secure attachment can adversely affect the user's ability to walk. On the other hand, an improper fit can cause sores, swelling and pain for the user.

One approach for overcoming this challenge has been the application of a negative pressure vacuum in a space between the limb, or a liner donned on the limb, and a socket or receptacle coupled to the prosthetic limb. Two conventional ways to apply such a vacuum are by a mechanical pump or an electronic pump.

Mechanical pumps are often in-line systems that utilize the movement of the user to generate the negative pressure vacuum in the socket. For example, the force generated by contacting the ground during a user's walking motion can be used to generate a vacuum in the socket space to hold the prosthesis to the user's limb. Because the impact and displacement of the pump is not consistent and varies between users, the vacuum and thus attachment between residual limb and the socket can be unpredictable and/or inadequate, causing the user discomfort, grief and even injury. Electronic pumps are bulky and significantly contribute to the weight of the prosthetic limb, imposing a significant weight burden on the user when walking.

Both types of pumps typically require users to monitor and regulate vacuum levels in the socket with a simple dial pressure gauge, which can be time consuming and labor intensive. Moreover, dial pressure gauge readings are prone to user error and can be inconsistent from one user or dial pressure gauge to another. Further, dial pressure gauges are known to malfunction and typically have limited accuracy limits and measurement ranges. In addition, even with good readings, users must manually activate the pump to increase vacuum and introduce air into the socket from environment to decrease vacuum.

<CIT> discloses a prosthetic system having a microprocessor-controlled socket evacuation device, and a method of retaining a prosthesis on the residual limb of an amputee using such an evacuation device. The evacuation device may include an electrically powered vacuum pump. A check valve is provided permitting a one-way air flow to the vacuum pump.

<CIT> discloses a vacuum pump system for a prosthesis device, in which an air-tight seal between a residual limb and a socket of the prosthesis allows a vacuum fit to be generated by a pump system controllable by instructions from a software program. Valves may be provided to restrict the air flow.

<CIT> discloses an apparatus and method for securing a prosthesis to the residuum of a limb of an amputee and for providing pressure therapy to the residuum. The apparatus includes a pressure control device operably connected to a chamber and capable of creating a positive pressure and a negative pressure within the chamber to provide pressure therapy to the residuum, as well as provide securement of the socket to the residuum.

<CIT> discloses a prosthetic device, system and method arranged to generate negative pressure inside a prosthetic socket. A pump mechanism is connected to a prosthetic foot and has a fluid chamber in fluid communication with the prosthetic socket during gait for drawing air from the prosthetic socket in step phase, and expelling air into the atmosphere in swing phase, which may be supported by a one-way valve.

<CIT> is considered to represent the closest prior art, it discloses a prosthetic device and connecting system using vacuum. The prosthetic device comprises a connecting portion for connecting to a person, wherein the control structure includes a vacuum pump which is in communication with the connecting portion for controlling an amount of vacuum used to connect the connecting portion to the person. Signals are provided by a vacuum and a movement sensing mechanisms.

In view of the shortcomings of conventional systems and methods, it is an object of the present invention to provide a vacuum suspension system in which the socket pressure more consistent, faster, less labor intensive, and provides higher accuracy.

The object is achieved by the features of independent claim <NUM>.

In a further development, the activity information advantageously can be used to regulate the vacuum inside of the socket and/or monitor use of the system. For example, if the activity information indicates a user is running or in a period of activity, the control system can direct the pump mechanism to increase the negative pressure inside of the socket, creating a more secure fit between the socket and the residual limb. If the activity information indicates the user is sitting or in a period of inactivity, the control system can direct pump mechanism to decrease the negative pressure inside of the socket, providing a looser, more comfortable fit.

The activity information may also be used to obtain vacuum performance information about the effectiveness of the pump mechanism. For instance, change in pressure inside the socket can be compared to tibia angle during stance and swing phases to determine the effectiveness of the pump mechanism during gait. In other embodiments, change in pressure inside the socket can be compared to relative movement between the residual limb and the socket to determine the effectiveness of the pump mechanism when the residual limb changes in volume and/or during use. In other embodiments, change in pressure inside the socket can be compared to movement between the prosthetic foot, pump mechanism, and/or other component and the socket. Thus, by comparing pressure changes in the socket with a specific activity or condition, the effectiveness of the pump system can advantageously be monitored and/or accessed.

Another benefit is that the activity information can be used to compile medical information about a user and/or prosthetic products, thus improving the possibilities for better treatment, better prosthetic products, and/or better reimbursement procedures. For example, the activity information can be used to assess and record the fitness, health, and/or activity level of an amputee. If the activity information indicates the user is highly active, it can be used to fit the user to a higher performance or sport prosthetic foot and/or socket.

These and other features, aspects, and advantages of the present invention will become better understood regarding the following description, appended claims, and accompanying drawings.

A better understanding of the invention may be had from the following description read with the accompanying drawings in which like reference characters refer to like elements.

The exemplary pump system can be used in various prosthetic systems, including, but not limited to, configurations of prosthetic sockets, prosthetic feet, vacuum suspension systems, prosthetic pylons, or any other suitable prosthetic system.

For instance, the exemplary pump system can be implemented with a vacuum suspension system <NUM>, as shown in <FIG>. The exemplary vacuum suspension system <NUM> includes a socket <NUM>, a liner <NUM> preferably including a seal component, a valve assembly <NUM>, a tube <NUM> connecting the pump system <NUM> to the socket <NUM>, and a prosthetic foot <NUM>. The socket <NUM> defines an interior space, and interior wall delimiting the interior space. The vacuum suspension system <NUM> may also employ an adaptor system <NUM>. Alternatively, the adaptor system <NUM> can include a shock and/or rotation module. The vacuum suspension system <NUM> provides improved proprioception and volume control since there is better attachment between the socket <NUM> and the residual limb.

The pump system <NUM> is secured to the adaptor system <NUM>. The pump system <NUM> is arranged to provide vacuum assisted suspension by generating a negative pressure (vacuum) inside the socket <NUM>, resulting in a secure and reliable elevated vacuum suspension that provides an intimate suspension as the negative pressure inside of the socket <NUM> or socket pressure holds the liner and the residual limb firmly to the socket wall.

One or more sensors <NUM> may be associated with the pump system <NUM>. The sensors <NUM> can be attached to or incorporated in the pump system <NUM>. The sensors <NUM> can be separate or remote from the pump system <NUM>. For instance, the sensors <NUM> can be attached to or incorporated in the socket <NUM> as shown. The sensors <NUM> may include pressure sensors detecting vacuum levels in the pump system <NUM> and/or socket <NUM>, or the fit of the liner <NUM> and/or socket <NUM> over the residual limb. The sensors <NUM> may include temperature sensors. The sensors <NUM> may include humidity sensors. The sensors <NUM> may include sensors to measure limb movement within the liner <NUM> and/or the socket <NUM>. The sensors <NUM> may include sensors to measure volume fluctuation of the residual limb throughout the day. The sensors <NUM> may include location sensors or sensors to determine how long the socket is worn or high periods of activity. The sensors <NUM> may include sensors for detecting heartrate and/or blood pressure of a user. It will be appreciated that other sensors may be used in the system <NUM> for different applications and for other diagnostic or physiological measurements.

Data or feedback from the sensors <NUM> can be used by the system <NUM> to obtain information related to the condition or state of the system <NUM> and/or user. For instance, data or feedback from the sensors <NUM> can be used by the pump system <NUM> to obtain pressure information, which, in turn, can be used to regulate the negative pressure inside the socket <NUM> and/or the pump system <NUM>. The pump system <NUM> can regulate the negative pressure inside the socket <NUM> by either increasing or decreasing the vacuum based on the pressure information. Decreasing vacuum can be done by introducing air from the environment into the socket <NUM>. This can be done by the pump system <NUM> and/or the valve assembly <NUM>. Increasing vacuum can be done by activating a pump mechanism of the pump system <NUM> to draw air out of the socket <NUM>.

Regulating the vacuum level inside the socket based on the pressure information is advantageous because the vacuum level inside of the socket <NUM> must be sufficient to secure the residual limb within the socket <NUM> and prevent pistoning but if it is too high it may strangle the residual limb, causing discomfort and/or cutting off circulation of the residual limb. Too much vacuum can be especially dangerous for users with vascular disease and/or reduced sensation in the residual limb. By regulating the vacuum inside the socket <NUM>, the pump system <NUM> thus provides a more secure, safe, and comfortable fit.

Optionally, the pressure information can be communicated to an end user, such as, but not limited to, a user (e.g., amputee), a computer device, a CPO (Certified Prosthetist/Orthotist), and/or a rehabilitation doctor by the pump system <NUM>. For instance, the pump system <NUM> can communicate to a CPO almost immediately if the socket <NUM> is or is not holding proper vacuum as opposed to requiring the end user to manually and repeatedly check vacuum levels in the socket using a dial pressure gauge as in the prior art. This approach assists in maximizing the comfort and safe use of the prosthesis. It also advantageously is faster, more accurate, and more consistent than conventional systems and methods.

Data or feedback from the sensors <NUM> can be used by the pump system <NUM> to obtain activity information associated with the user and/or system. The activity information associated with the user can include heartrate, blood pressure, breathing rate, and/or other types of information. Such information can be used to regulate the vacuum inside of the socket <NUM> and/or the system <NUM>. For example, if the activity information indicates a user is running or descending stairs, the pump system <NUM> can direct the pump mechanism described below to increase the negative pressure inside of the socket <NUM>, creating a more secure fit between the socket <NUM> and the user's residual limb. If the activity information indicates the user is sitting, the pump system <NUM> can direct pump mechanism to decrease the negative pressure inside of the socket <NUM>, providing a looser, more comfortable fit.

The activity information can also be used to obtain vacuum performance information about the effectiveness of the pump mechanism. For instance, change in pressure inside the socket <NUM> can be compared to tibia angle during stance and swing phases to determine the effectiveness of the pump mechanism during gait. In other implementations, change in pressure inside the socket <NUM> can be compared to relative movement between the residual limb and the socket <NUM> to determine the effectiveness of the pump mechanism when the residual limb changes in volume and/or during use.

In other implementations, change in pressure inside the socket <NUM> can be compared to movement between the prosthetic foot, pump mechanism, and/or other component and the socket. Thus, by comparing pressure changes in the socket <NUM> with a specific activity or condition, the effectiveness of the pump system <NUM> can advantageously be monitored and/or accessed.

Another benefit is that the activity information can be used to compile medical information about the user and/or prosthetic products, thus improving the possibilities for better treatment, better prosthetic products, and/or better reimbursement procedures. For example, the activity information can be used to assess and record the fitness, health, and/or activity level of a user or amputee. In an implementation, the sensors <NUM> can sense heartrate or blood pressure of the user. Data including information related to the heartrate or blood pressure can then be communicated from the sensors <NUM> or pump system <NUM> to the cloud, a computer device, or a computer system described below so that a third party can access and use the data to monitor the overall health and/or stress of the user.

Further, exemplary implementations of a pump system can be implemented directly with a socket, as shown in <FIG>. For instance, a vacuum suspension system 1A can include socket 5A, a prosthetic foot 13A, and an adaptor system 15A connecting the socket 5A to the prosthetic foot 13A. A pump system 3A can be secured directly to a sidewall of the socket 5A. Because the pump system 3A is located at the socket 5A, there is no need to move fluid drawn into the pump system 3A from the socket 5A down to another prosthetic component such as the foot 13A. This advantageously reduces the time to produce an elevated vacuum in the socket 5A. Further, it can eliminate the need for a long tube extending between the pump mechanism and another component, reducing the likelihood of leaks and increasing the accuracy of the pump system 3A.

<FIG> shows yet another pump system implemented with a prosthetic foot. As seen, a vacuum suspension system 1B can include a prosthetic foot 13B and a pump system 3B can be secured directly to the foot 13B. A tube 11B can fluidly connect the pump system 3B to a prosthetic socket. The pump system 3B can be secured to the foot 13B such that there is a reduced likelihood of the pump system 3B undesirably affecting the functionality of the foot 13B, providing a more natural gait. The pump system 3B can be located on a proximal surface of the foot 13B, providing a sleek and low-profile design.

<FIG> illustrate a pump system. As seen, a pump system <NUM> can include a housing <NUM> containing a pump mechanism <NUM> arranged to be in fluid communication with the cavity of the socket <NUM>. The pump mechanism <NUM> can be operable to draw out of the socket <NUM> and/or introduce air into the socket <NUM>.

At least one valve assembly <NUM> is in fluid communication with the pump mechanism <NUM> that can control the flow of fluid (e.g., air) into and/or out of the pump mechanism <NUM>. For instance, the at least one valve assembly <NUM> can include an inlet valve that only allows fluid to enter the pump mechanism <NUM>, which can be connected to a tube system <NUM> as shown. The pump mechanism <NUM> can draw fluid (e.g., air) out from the socket <NUM> via the tube system <NUM> and the inlet valve.

The at least one valve assembly <NUM> can include an outlet valve that only allows fluid to be expelled out of the pump mechanism <NUM>, preferably to atmosphere. The inlet and outlet valves can be integrated in the same valve assembly.

Similar to the previous implementations, one or more sensors <NUM> can be associated with the pump system <NUM>. The sensors <NUM> can be separate or remote from the pump system <NUM>. The sensors <NUM> can be attached to or incorporated in the pump system <NUM>. For instance, the sensors <NUM> can include a pressure sensor <NUM> attached to the housing <NUM> for measuring pressure levels in the pump system <NUM> and/or the fit of the liner <NUM> and/or socket <NUM> over the residual limb. In an implementation, the pressure sensor <NUM> can measure pressure levels inside the socket <NUM> during use. The pressure sensor <NUM> can be in fluid communication with the pump mechanism <NUM>, the socket <NUM>, and/or the tube system <NUM>.

The pump system <NUM> can obtain pressure information associated with the socket <NUM> and/or pump system <NUM> from the pressure data or feedback provided by the pressure sensor <NUM>. Obtaining the pressure information can include reading the data, analyzing the data, transforming the data, and/or processing the data. The pressure information obtained by the pump system <NUM> advantageously can be used to regulate the vacuum inside of the socket <NUM> and/or monitor use of the system <NUM>, providing a more comfortable and/or safer fit. For instance, if the pressure information indicates that the pressure within the socket <NUM> is too high, the pump system <NUM> can direct to the pump mechanism <NUM> to create negative pressure inside of the socket <NUM>.

The sensors <NUM> can include a location sensor <NUM>. The location sensor <NUM> is shown positioned on and/or inside of the housing <NUM> but can be positioned in any suitable location. The location sensor <NUM> can detect the location and/or motion of one or more components of the vacuum suspension system <NUM>. For instance, the location sensor <NUM> can detect the location and/or motion of the pump mechanism <NUM>, the residual limb, the socket, the prosthetic foot, the user, terrain, anatomical parts, and/or other suitable parts.

The pump system <NUM> is arranged to obtain activity information from the data or feedback provided by the location sensor <NUM>. The activity information can be associated with one or more components of the system <NUM> such as, but not limited to, the socket <NUM>, the pump mechanism <NUM>, the prosthetic foot, the residual limb, and/or any other components or anatomical parts. Obtaining the activity information can include the pump system <NUM> reading the data, analyzing the data, transforming the data, and/or processing the data.

The activity information advantageously can be used to regulate the vacuum inside of the socket <NUM> and/or monitor use of the system <NUM>. For example, if the activity information indicates a user is running, the pump system <NUM> can direct the pump mechanism to increase the negative pressure inside of the socket <NUM>, creating a more secure fit between the socket <NUM> and the residual limb. If the activity information indicates the user is sitting, the pump system <NUM> can direct pump mechanism <NUM> to decrease the negative pressure inside of the socket <NUM>, providing a looser, more comfortable fit.

The activity information can also be used to obtain vacuum performance information about the effectiveness of the pump mechanism. For instance, change in pressure inside the socket <NUM> can be compared to tibia angle during stance and swing phases to determine the effectiveness of the pump mechanism during gait. In other implementations, change in pressure inside the socket <NUM> can be compared to relative movement between the residual limb and the socket <NUM> to determine the effectiveness of the pump mechanism when the residual limb changes in volume and/or during use. In other implementations, change in pressure inside the socket <NUM> can be compared to movement between the prosthetic foot, pump mechanism, and/or other component and the socket. Thus, by comparing pressure changes in the socket <NUM> with a specific activity or condition, the effectiveness of the pump system can advantageously be monitored and/or accessed.

The location sensor <NUM> can include an inertial measurement unit (IMU) having at least one accelerometer, gyroscope, and/or magnetometer. The location sensor <NUM> can include a strain gauge, a force sensitive resistor, and/or a distance sensor. The location sensor <NUM> can be a light sensor, a force sensor, a motion sensor, a position sensor, a time detector (e.g., timer, clocks), temperature sensor, and/or any other suitable type of sensing device.

It will be appreciated that any of the sensing capabilities disclosed herein can be present in a single sensor or an array of sensors. Further, sensing capabilities are not limited to a particular number or type of sensors. Moreover, the sensors can be located in any suitable portion of the vacuum suspension system <NUM>. For instance, at least one of the sensors can be located in the tubing system, the socket, or the liner.

The pump system <NUM> can include a feedback system <NUM> for communicating at least a portion of the information obtained by the pump system <NUM> to an end user. In an implementation, the feedback system <NUM> can communicate to the end user when the pressure information indicates the pressure inside the socket <NUM> is above a value limit. For instance, the feedback system <NUM> can include a set of three light emitting diodes <NUM> and a vibrator <NUM>. If the pressure information obtained by the pump system <NUM> indicates the pressure in the socket <NUM> is good, the feedback system <NUM> can illuminate a green LED 33A, communicating to the end user that the vacuum is good. If the pressure information indicates the pressure in the socket <NUM> is poor, the feedback system <NUM> can illuminate a yellow LED 33B and/or vibrate the vibrator <NUM>, alerting the end user that the vacuum is poor.

If the pressure information obtained by the pump system <NUM> indicates the pressure in the socket <NUM> is too high, the feedback system <NUM> can illuminate a red LED 33C, alerting the end user that the vacuum is too much. The pump system <NUM> can thus communicate to the end user almost immediately if the socket <NUM> is or is not holding proper vacuum as opposed to requiring a user to manually and repeatedly check vacuum levels in the socket, improving user comfort and safe use. It also has the effect of reducing the likelihood of user error because the user is not required to a read a dial pressure gauge. It is also advantageously faster, more accurate, and more consistent than conventional systems and methods.

In other implementations, the feedback system <NUM> can include an audible feedback alarm, a feedback alarm that shocks a user, and/or any suitable type of interface device. In yet other implementations, one or more portions of the feedback system <NUM> can be integrated with a mobile device described below.

<FIG> illustrate a pump mechanism 21A according to an implementation. The pump mechanism 21A can include a pump housing <NUM>, a membrane <NUM>, and an actuator <NUM>. The pump mechanism 21A relies upon deformation of the membrane <NUM> to move between an original configuration in which the volume of a fluid chamber <NUM> defined between the membrane <NUM> and the pump housing <NUM> is zero or near-zero, and an expanded configuration in which the volume of the fluid chamber <NUM> is increased. The pump housing <NUM> is arranged to surround the outer radial edge of the membrane <NUM> and creates a seal with the membrane <NUM>. The pump housing <NUM> can define at least one opening that extends into the pump housing <NUM> to form at least one internal passageway <NUM> to provide fluid communication between the fluid chamber <NUM> and a socket. In an implementation, the internal passageway <NUM> can be in fluid communication with the fluid chamber <NUM> and at least one valve <NUM> of the pump system <NUM>. Optionally, the at least one valve <NUM> can be attached directly to the pump housing <NUM> as seen in <FIG>. In other implementations, the at least one valve <NUM> can be separate from the pump housing <NUM>.

The actuator <NUM> can move the pump mechanism 21A between the original and expanded configurations. For instance, rotation of the actuator <NUM> in a first direction can move the pump mechanism 21A toward the expanded configuration and rotation of the actuator <NUM> in a second direction, opposite the first, can move the pump mechanism 21A toward the closed configuration. The actuator <NUM> can be driven by any suitable drive module.

In other implementations, the pump mechanism <NUM> can be an electric vacuum generator, a membrane-type pump, a bladder-type pump, a peristaltic pump, a piston-type pump, or any other suitable pump mechanism.

As seen in <FIG>, a control system <NUM> can be associated with the pump system <NUM>. The control system <NUM> can be operable to control operation of one or more of the foregoing system components (e.g., pump mechanism <NUM>, valve assembly <NUM>, sensors <NUM>, feedback system <NUM>). The control system <NUM> can be internal to or external to the pump system <NUM>. The control system <NUM> may be programmable for regulating pressure inside the socket <NUM> and/or monitoring activity of the user and/or vacuum suspension system <NUM>.

The control system <NUM> can include an input/output (I/O) module <NUM>. The I/O module <NUM> can communicate with the pump system <NUM>, the valve assembly <NUM>, an end user, other modules of the control system <NUM>, and/or other devices. A processing module <NUM> can execute computer executable instructions and/or process data. The processing module <NUM> may be operably coupled to a memory <NUM>. The memory <NUM> can store an application including computer executable instructions, measurement data, and/or operational data constituting a program to perform certain acts (e.g., a part program, a software control program, etc.). For example, the processing module <NUM> may be operably coupled to the memory <NUM> storing an application including computer executable instructions and data constituting a customized program to regulate vacuum in the socket <NUM>.

The memory <NUM> may be embodied as a computer readable medium, such as a random access memory ("RAM"), a hard disk drive, or a static storage medium such as a compact disk, DVD, or the like. The memory <NUM> may include the cloud or a network described below. The memory <NUM> may further store information and/or data obtained by the pump system <NUM>.

Through the I/O module <NUM>, a sensing module <NUM> can direct one or more of the sensors <NUM> to detect pressure levels in the socket <NUM> and/or the vacuum suspension system <NUM>. According to a variation, the sensing module <NUM> can direct one or more of the sensors <NUM> to detect movement/location of different components of the vacuum suspension system <NUM>. In other implementations, the sensing module <NUM> can direct one or more of the sensors <NUM> to detect heartrate and/or blood pressure of the user.

Upon receiving data from the sensors <NUM>, a regulating module <NUM> can direct the pump mechanism <NUM> to vary the vacuum in the socket <NUM> and/or vacuum suspension system <NUM>. The regulating module <NUM> and/or the processing module <NUM> can obtain pressure information from the data collected by the sensors <NUM>. Based on the pressure information, the regulating module <NUM> can direct the pump mechanism <NUM> to increase and/or decrease the vacuum in the socket <NUM>. For instance, if the pressure information indicates that the vacuum in the socket <NUM> is too low, the regulating module <NUM> can direct the pump mechanism <NUM> to increase the vacuum. If the pressure information indicates the vacuum in the socket <NUM> is too high, the regulating module <NUM> can direct the valve assembly <NUM> to decrease the vacuum in the socket <NUM> by introducing air into the socket <NUM>. As noted above, obtaining the pressure information can include reading the data, analyzing the data, transforming the data, and/or processing the data.

A feedback module <NUM> can direct the feedback system <NUM> to communicate information obtained by the pump system <NUM> to an end user (e.g., user or CPO) via the I/O module <NUM>. For example, if the pressure information indicates that the vacuum in the socket <NUM> is too low, the feedback module <NUM> can direct the yellow LED 33B to illuminate and/or the vibrator <NUM> to vibrate, alerting the end user of a potential dangerous fit between the socket <NUM> and the residual limb. In other implementations, the control system <NUM> can include a monitoring module for obtaining the pressure information which can then be communicated to a user, CPO, and/or other intended party via the I/O module <NUM> for monitoring purposes. For instance, the regulating module <NUM> and/or the feedback module <NUM> may be omitted and the control system <NUM> may include the monitoring module. In other implementations, the monitoring module may be integrated with the regulating module.

The control system <NUM> can be internal to or external to the pump system <NUM>. For instance, the control system <NUM> can comprise or can be operably coupled to a system <NUM> having a computer device <NUM> as seen in <FIG>.

The computer device <NUM> can display information to an end user and receive user input, respectively. As seen, the computer device <NUM> preferably is a mobile device. A mobile device is defined as a processing device routinely carried by a user. It typically has a display screen with touch input and/or a keyboard, and its own power source. As such, the computer device <NUM> can provide a user the freedom to use it almost anywhere.

The computer device <NUM> can be a hand-held device. The computer device <NUM> can be a tablet computer, a smartphone, a laptop, a mobile telephone, a PDA, or other appropriate device. It will be appreciated that any of the methods and systems described herein may be adapted to couple the pump system <NUM> to a computer device <NUM> such as a desktop computer or the like in place of the mobile device.

The computer device <NUM> is communicatively coupled to the pump system <NUM>. The computer device <NUM> can be communicatively coupled to a server or computer system <NUM> over a network <NUM>, such as for example, a Local Area Network ("LAN"), a Wide Area Network ("WAN"), and even the internet. The computer system <NUM> can be located remotely from the computer device <NUM>. The computer system <NUM> can be used for controlling and/or monitoring the computer device <NUM> and/or the pump system <NUM>. The computer system <NUM> can be used for exchanging information/files with the computer device <NUM> and/or pump system <NUM>. For instance, the pump system <NUM> can send one or more files including pressure information and activity information to the computer device <NUM>.

The exact division of labor between the computer device <NUM>, the pump system <NUM>, and the computer system <NUM> may vary. For instance, the computer device <NUM> can perform nearly all operations and the pump system <NUM> merely carries out instructions that are received from the computer device <NUM>. At the other end of the spectrum, the computer device <NUM> receives and stores data/files from the pump system <NUM>, and the pump system <NUM> performs all other operations. Any division of labor between the pump system <NUM>, the computer device <NUM>, and the computer system <NUM> is also within the scope of the present disclosure.

A vacuum regulating routine or application of the pump system <NUM> will now be described. First, a vacuum regulating routine or application can be initiated in which the pump system <NUM> directs the sensors <NUM> to measure the vacuum in the socket <NUM> (shown in <FIG>). This can include receiving user input specifying the initiation of the routine by the pump system <NUM> and/or other feedback or input. Upon initiation of the routine, the sensing module <NUM> can output one or more sensing instructions via the I/O module <NUM> to the pressure sensor <NUM> without human intervention (e.g., without input from an operator). Automatically and without human intervention, the pressure sensor <NUM> can measure the pressure level within the socket <NUM> in accordance with the measurement instructions. The pressure data can be sent to one or more of the modules and/or stored in the memory <NUM> via the I/O module <NUM>.

Upon receiving the pressure data, the regulating module <NUM> can obtain pressure information from the pressure data. Obtaining the pressure information can include reading the data, analyzing the data, transforming the data, and/or processing the data. For example, the regulating module <NUM> and/or the processing module <NUM> can compare the pressure data to a value limit stored in the memory to obtain the pressure information.

Based on the pressure information, the regulating module <NUM> can output one or more pumping instructions via the I/O module <NUM> to the pump mechanism <NUM>. If the pressure information indicates the pressure in the socket <NUM> is above the value limit, the pumping instructions can direct the pump mechanism <NUM> to increase the vacuum in the socket <NUM>. If the pressure information indicates the pressure in the socket <NUM> is below the value limit, the pump instructions can direct the pump mechanism <NUM> and/or the valve assembly <NUM> (shown in <FIG>) to decrease the vacuum in the socket <NUM>. The pump mechanism and/or valve assembly <NUM> can then increase and/or decrease the pressure in the socket <NUM> based on the pumping instructions.

The value limit can be a singular value, a set of values, or a range of values. The value limit can be a relative or absolute pressure level. The value limit can be a range of target pressure levels. The value limit can be selected based on user activity criteria and/or any other suitable criteria. In an implementation, the value limit can be set using an application on the computer device <NUM> or hand-held device.

A feedback routine can include the feedback module <NUM> outputting one or more feedback instructions via the I/O module <NUM> to the feedback system <NUM> based upon the pressure information. For instance, if the pressure information indicates that the vacuum in the socket <NUM> is good, the feedback instructions can direct the green LED 33A to illuminate, confirming a secure and comfortable fit between the socket <NUM> and the residual limb. If the pressure information indicates that the vacuum is too high, the feedback instructions can direct the red LED 33C to illuminate, alerting the end user of a fit between the socket <NUM> and the residual that may be too tight. If the pressure information indicates that the vacuum is poor, the feedback instructions can direct the yellow LED 33B to illuminate, alerting the end user that the socket <NUM> may detach from the residual limb. The feedback instructions can also direct the vibrator <NUM> to vibrate if the pressure information indicates the vacuum is poor and/or too high, providing the user feedback regarding whether there is a proper fit between the residual limb and the socket <NUM>.

In some implementations, the feedback instructions can instruct the I/O module <NUM> to send the pressure information to the network <NUM> and/or computer system <NUM> through the computer device <NUM> for additional analysis and/or storage.

An activity routine or application will now be described. First, an activity routine can be initiated in which the pump system <NUM> directs the sensors <NUM> to measure the activity of a user. This can include receiving user input specifying the initiation of the routine by the pump system <NUM> and/or feedback from one or more of the sensors <NUM>. Upon initiation of the routine, the sensing module <NUM> can output one or more sensing instructions via the I/O module <NUM> to the location sensor <NUM>.

The location sensor <NUM> can measure the activity of the user in accordance with the sensing instructions. For instance, the location sensor <NUM> can measure movement of the pump mechanism <NUM> based on the sensing instructions. The location sensor <NUM> can measure movement of the prosthetic foot <NUM> based on the sensing instructions. The location sensor <NUM> can measure the load and/or moment on the prosthetic foot <NUM> based on the sensing instructions. The location sensor <NUM> can measure movement of the residual limb relative to the socket <NUM> based on the sensing instructions. The location sensor <NUM> can measure stride, stride count, and/or stride count over time based on the sensing instructions. The location sensor <NUM> can measure speed and/or cadence of the user's gait based on the sensing instructions. The location sensor <NUM> can measure terrain based on the sensing instructions such as, for example, but not limited to, grade, ground hardness, and/or stairs climbing up and down. The location sensor <NUM> can measure stride time, stance time, swing time, active time on the prosthetic socket <NUM>, and/or inactive time on the prosthetic socket <NUM> based on the sensing instructions. The location sensor <NUM> can measure tibia angle during stance and/or swing phase based on the sensing instructions. In other implementations, the location sensor <NUM> and/or another one of the sensors <NUM> can measure the user's heart rate, blood pressure, and/or breathing rate.

The data collected by the location sensor <NUM> can be sent to one or more modules and/or stored in the memory <NUM> via the I/O module <NUM>. For example, the processing module <NUM> and/or the regulating module <NUM> can obtain activity information from the data collected by the location sensor <NUM>, which, in turn, can be used to compile medical information about the user, information about the vacuum suspension system, the pump system, and/or the prosthetic foot. The activity information can be associated with one or more components of the system <NUM>.

In some implementations, the activity information can be used by the regulating module <NUM> and/or other modules to regulate the vacuum in the socket. For example, if the activity information indicates the user is in a period of activity or exercising (e.g., hiking, running, jogging, walking, jumping, climbing, or the like) the regulating module <NUM> can send pumping instructions to the pump mechanism <NUM> directing it to increase the vacuum in the socket <NUM>. If the activity information indicates the user is in a period of inactivity, the regulating module <NUM> can send pumping instructions to the pump mechanism <NUM> directing it to decrease the vacuum in the socket <NUM>. By way of example, if the activity information indicates the user is skiing and the vacuum inside the socket <NUM> is not sufficient to maintain the connection between the socket <NUM> and the residual limb during skiing, the feedback module <NUM> can send feedback instructions to the feedback system <NUM> to warn the user of insufficient vacuum. Using the activity information to regulate the vacuum in the socket increases user comfort and safe use of the prosthesis.

It also allows for the gathering of medical information about the user and/or prosthetic foot, thus improving the possibilities for better treatment, better prosthetic products, and/or better reimbursement procedures. For instance, the activity information can provide information about the performance of the prosthetic foot during walking or stretching. In other implementations, the activity information can provide information about the user's health during specific activities or in general. For instance, the activity information can provide information to a third party medical professional that the user is having a heart attack or stroke.

The activity information can also be used to evaluate performance of the pump mechanism <NUM>. For instance, a vacuum performance routine or application implementationwill now be described. The vacuum performance routine can be similar to the routines previously described except that it obtains vacuum performance information from the pressure and activity information.

In an implementation, pressure information can be compared to activity information during a specific activity to evaluate the activity effectiveness of the pump system <NUM> and/or pump mechanism <NUM>. By way of example, change in pressure inside the socket <NUM> can be compared to tibia angle during stance and swing phases to determine the effectiveness of the pump mechanism during gait. In other implementations, change in pressure inside the socket <NUM> can be compared to relative movement between the residual limb and the socket <NUM> to determine the effectiveness of the pump mechanism when the residual limb changes volume and/or during use of the vacuum suspension system. In other implementations, change in pressure inside the socket <NUM> can be compared to movement between the prosthetic foot, pump mechanism, and/or other component and the socket.

Thus, by comparing pressure changes in the socket <NUM> with a specific activity or condition, the effectiveness of the pump system <NUM> can advantageously be monitored and/or accessed. Further, the pump system <NUM> can be controlled based on different needs and/or activities of a user, providing versatility and useful information.

In addition to the foregoing, one will appreciate that implementations can also be described in terms of flowcharts including one or more steps for accomplishing a particular result. For instance, the steps of <FIG> and the corresponding text describe steps in a method for regulating vacuum in a socket with a pump system. The steps in <FIG> are described below with respect to the components and modules in <FIG>.

For instance, <FIG> illustrates a method <NUM> in accordance with the present disclosure for regulating vacuum in a socket with a pump system includes a step <NUM> measuring pressure inside of a prosthetic socket using one or more sensors operatively coupled to a pump system to obtain pressure information associated with the inside of the socket. Step <NUM> can include the control system obtaining the pressure information from the data provided by the pressure sensor. For instance, <FIG> and the accompanying description depict and describe the regulating module <NUM> comparing data from the pressure sensor to a value limit to obtain pressure information and outputting pumping instructions to the pump mechanism based on the pressure information.

Additionally, <FIG> shows that the method <NUM> can include a step <NUM> of actuating the pump mechanism without human intervention to regulate vacuum inside the prosthetic socket based on the pressure information. Step <NUM> can include the control system outputting pumping instructions directing the pump mechanism to increase or decrease the vacuum in the socket based on the pressure information. For instance, <FIG> and the accompanying description depict and describe the regulating module transmitting pumping instructions to the pump mechanism and/or valve assembly to increase or decrease the vacuum in the socket based on the pressure information. The pump mechanism and/or the valve assembly can then vary the vacuum inside of the prosthetic socket based on the pumping instructions.

Accordingly, <FIG> provide a number of components, schematics and mechanisms for regulating a vacuum in a prosthetic socket with a pump system based on feedback from one or more sensors. This has the effect of providing a more secure, safe, and comfortable fit between the socket and the residual limb. This also advantageously is faster, more accurate, and more consistent than conventional systems and methods.

Many of the elements described may be implemented as modules. A module is defined here as an isolatable element that performs a defined function and has a defined interface to other elements. The modules described in this disclosure may be implemented in hardware, a combination of hardware and software, firmware, or a combination, all of which can be behaviorally equivalent. Modules may be implemented using computer hardware in combination with software routine(s) written in a computer language. It may be possible to implement modules using physical hardware that incorporates discrete or programmable analog and/or digital hardware. Examples of programmable hardware include computers, microcontrollers, microprocessors, application-specific integrated circuits, field programmable gate arrays, and complex programmable logic devices.

As noted above, the pressure regulating, activity monitoring, and/or vacuum performance routines or applications may be software embodied on a computer readable medium which when executed by a processor component of a computer device performs a sequence of steps. The application may be a mobile application or application software configured to run on smartphones, tablets computers, and/or other mobile devices.

Moreover, the implementations of the present disclosure may comprise or utilize a special-purpose or general-purpose computer system that includes computer hardware, such as, for example, one or more processors and system memory, as discussed in greater detail below. Implementations of the present disclosure also include physical and other computer-readable media for carrying or storing computer-executable instructions and/or data structures. Such computer-readable media can be any available media that can be accessed by a general-purpose or special-purpose computer system. Computer-readable media that store computer-executable instructions and/or data structures are computer storage media. Computer-readable media that carry computer-executable instructions and/or data structures are transmission media. Thus, by way of example, and not limitation, the present disclosure can comprise at least two distinctly different kinds of computer-readable media: computer storage media and transmission media.

Computer storage media are physical storage media that store computer-executable instructions and/or data structures. Physical storage media include computer hardware, such as RAM, ROM, EEPROM, solid state drives ("SSDs"), flash memory, phase-change memory ("PCM"), optical disk storage, magnetic disk storage or other magnetic storage devices, or any other hardware storage device(s) which can be used to store program code in the form of computer-executable instructions or data structures, which can be accessed and executed by a general-purpose or special-purpose computer system to implement the disclosed functionality of the disclosure.

Further, upon reaching various computer system components, program code in the form of computer-executable instructions or data structures can be transferred automatically from transmission media to computer storage media (or vice versa). For example, computer-executable instructions or data structures received over a network or data link can be buffered in RAM within a network interface module (e.g., a "NIC"), and then eventually transferred to computer system RAM and/or to less volatile computer storage media at a computer system.

Those skilled in the art will appreciate that the disclosure may be practiced in network computing environments with many types of computer system configurations, including, personal computers, desktop computers, laptop computers, message processors, hand-held devices, multi-processor systems, microprocessor-based or programmable consumer electronics, network PCs, minicomputers, mainframe computers, mobile telephones, PDAs, tablets, pagers, routers, switches, and the like. The disclosure may also be practiced in distributed system environments where local and remote computer systems, which are linked (either by hardwired data links, wireless data links, or by a combination of hardwired and wireless data links) through a network, both perform tasks. As such, in a distributed system environment, a computer system may include a plurality of constituent computer systems.

Those skilled in the art will also appreciate that the disclosure may be practiced in a cloud computing environment.

A cloud computing model can be composed of various characteristics, such as on-demand self-service, broad network access, resource pooling, rapid elasticity, measured service, and so forth. A cloud computing model may also come in the form of various service models such as, for example, Software as a Service ("SaaS"), Platform as a Service ("PaaS"), and Infrastructure as a Service ("IaaS"). The cloud computing model may also be deployed using different deployment models such as private cloud, community cloud, public cloud, hybrid cloud, and so forth.

Claim 1:
A vacuum suspension system (<NUM>) comprising:
a prosthetic socket (<NUM>) adapted for receiving a residual limb;
a pump system (<NUM>) including a pump mechanism (<NUM>) in fluid communication with the prosthetic socket (<NUM>);
a plurality of sensors (<NUM>, <NUM>) associated with at least one of the prosthetic socket (<NUM>) and the pump mechanism (<NUM>);
a control system (<NUM>) operably connected to the pump mechanism (<NUM>) and the plurality of sensors (<NUM>, <NUM>), the control system (<NUM>) arranged to receive and process data from the plurality of sensors (<NUM>, <NUM>) and to actuate the pump mechanism (<NUM>) based on the received data from the plurality of sensors (<NUM>, <NUM>); a regulating module (<NUM>) arranged to receive information from the plurality of sensors (<NUM>, <NUM>); and
at least one valve assembly (<NUM>) in fluid communication with the pump system (<NUM>), the at least one valve assembly (<NUM>) being controllable by the control system (<NUM>) and adjusted according to direction from the regulating module (<NUM>);
characterized in that
the plurality of sensors (<NUM>,<NUM>) is arranged to measure at least volume fluctuation of the residual limb, pressure changes inside the prosthetic socket, and relative movement between the residual limb and the prosthetic socket;
the data from the plurality of sensors is representative of the pressure changes inside the prosthetic socket, the relative movement between the residual limb and the prosthetic socket, and the volume fluctuation of the residual limb over a period of time; and
the control system (<NUM>) is arranged to generate vacuum performance information representative of an effectiveness of the pump mechanism by comparing the pressure change inside the prosthetic socket and relative movement between the residual limb and the prosthetic socket when the volume of the residual limb fluctuates.