Modular Prosthesis System

Abstract

The disclosure describes an adjustable modular prosthesis system comprising of repeating and interconnecting modular linkages. The modular linkages can be configured in a number of ways to form a network of modular linkages that comprise an adjustable custom socket around the limb of a user. The disclosed system further comprises a tensioning system that allows a user to control the socket's fit around their limb. The disclosed prosthesis system has a very low unique part count, may be mass-produced at low cost, and provides easy-to-use means of adjusting the shape and size of the socket to correspond with changes in a user's limb.

Claims

1. An adjustable prosthesis system comprising: a plurality of interconnecting, repeating major and minor modular linkages configured to form a socket around the limb of the user; wherein the socket comprises a configurable network of modular linkage connections; at least one tensioning element securing the plurality of modular linkages to the user's limb; at least one tensioner attached to one or more tensioning elements, configured to allow for tension adjustment by the user without clinical assistance.

2. The adjustable prosthesis system of claim 1, comprising a mechanical coupling element to join the socket and prosthesis, distal to a joint of a user, by attaching to the plurality of interconnecting major and minor modular linkages.

3. The adjustable prosthesis system of claim 2, wherein the mechanical coupling element comprises a configuration of interconnecting modular linkages.

4. The adjustable prosthesis system of claim 1, wherein the modular linkages comprise a tensioning anchor on the modular linkage side distal to the user's limb that is configured to permit guidance of a tensioning element through a center of the tensioning anchor so as to create an adjustable suspension.

5. The adjustable prosthesis system of claim 1, wherein the modular linkages comprise one or more of acrylonitrile butadiene styrene, polyether ether ketone, polyetherketoneketone, polyetherimide, acrylonitrile styrene acrylate, polyethylene terephthalate, polycarbonate, and polylactic acid.

6. The adjustable prosthesis system of claim 1, wherein the modular linkages are configured to permit a connection of a functional module dock which is configured to hold one or more functional elements, comprising one or more of GPS tracking device, interactive display, personal cellular phone, motor, batteries, data storage and communication device, graphical user interface, buttons, microphone, speaker, and processing unit.

7. The adjustable prosthesis system of claim 1, wherein the minor modular linkages each comprise a central tube, a minor solid sector extending from and wrapping around approximately one-third of an exterior side of the central tube, a beam extending from the diametrically opposite exterior side of the central tube, and a curved member arcing from one radius line of the minor solid sector's end, through the beam's lateral end, to the other radius line of the minor solid sector's end; wherein the major modular linkages each comprise a central tube, a major solid sector extending from and wrapping around approximately two-thirds of an exterior side of the central tube, a beam extending from the diametrically opposite exterior side of the central tube, and a curved member arcing from one radius line of the major solid sector's end, through the beam's lateral end, to the other radius line of the major solid sector's end.

8. The adjustable prosthesis system of claim 7, wherein neither the major nor minor modular linkages comprise a beam; wherein the curved member extends from one radius line of the solid sector's end to the other radius line of the solid sector's end.

9. The adjustable prosthesis system of claim 7, wherein the minor solid sector has a hollow linking channel running along the minor solid sector and configured so that another modular linkage may be connected by inserting either the curved member of another modular linkage alone or the curved member and beam of the other modular linkage therein; wherein the major solid sector has two hollow linking channels along either side of the major solid sector and configured so that other modular linkages may be connected into one or both hollow linking channels by inserting either the curved member of another modular linkage alone or the curved member and beam of the other modular linkage therein.

10. The adjustable prosthesis system of claim 7, wherein the hollow linking channels of the major and minor solid sectors contain a directionally biased snapping mechanism configured to allow insertion of another modular linkage therein.

11. The adjustable prosthesis system of claim 10, wherein the direction and axis of insertion is orthogonal to the direction and axis of linkage.

12. The adjustable prosthesis system of claim 10, wherein the range of motion of the prosthesis system can be configured by the connection of modular linkages; wherein insertion of both the curved member and the beam of a first modular linkage into the hollow linkage channel of a second modular linkage limits range of motion; wherein insertion of only the curved member of a first modular linkage into the hollow linkage channel of a second modular linkage enables range of motion.

13. The adjustable prosthesis system of claim 10, wherein the major and minor modular linkages comprise diametrically opposite notches on either side of the hollow linking channel allowing for further range of motion orthogonal to the axis of linkage.

14. The adjustable prosthesis system of claim 7, wherein a friction element partially overlaps the central tube and fully overlaps the minor or major solid sector of the modular linkage; wherein the friction element is configured to distribute load and reduce how tight the socket must be configured to remain on a user's limb.

15. The adjustable prosthesis system of claim 14, wherein the central tube is configured to allow connection of a replaceable friction element medial to the user's limb via an insertable member that fits into the tube linkage.

16. The adjustable prosthesis system of claim 7, wherein the central tube is configured to contain a sensor system medial to the user's limb, with a plurality of wires of the sensor system running through the central tube and out of a distal side of the central tube; wherein the sensor system is in communication with a processing unit.

17. The adjustable prosthesis system of claim 16, wherein the central tube is configured to contain a stimulating element that is controlled by a processing unit on the basis of input received at the sensor system.

18. The adjustable prosthesis system of claim 1, wherein one or more tensioning elements comprise a lacing system.

19. The adjustable prosthesis system of claim 1, comprising a ratcheting dial tensioner which the user can operate using one hand.

20. The adjustable prosthesis system of claim 1, comprising an outer load-sharing structure that redistributes load to improve load spread and transfer around the user's limb.

21. The adjustable prosthesis system of claim 20, wherein the outer load-sharing structure is configured to secure the socket to the limb so that the tensioning element isn't necessary.

Description

BRIEF DESCRIPTION OF THE FIGURES

[0008] The various advantages of the embodiments will become apparent to one skilled in the art by reading the following specification and referencing the following figures, in which:

[0009] FIG. 1 is an embodiment of the prosthesis system comprising a network of repeating and interconnecting major and minor modular linkages to form a socket.

[0010] FIG. 2 is an embodiment of the prosthesis system comprising a network of repeating and interconnecting major and minor modular linkages to form a socket around a user's residual limb.

[0011] FIG. 3 is an embodiment of the mechanical coupling element comprising of repeating and interconnecting major and minor modular units placed on a user's residual limb.

[0012] FIG. 4 is an embodiment of the prosthesis system further comprising a functional module dock and a tensioner and where the mechanical coupling element connects to a network of modular linkages that comprise a socket.

[0013] FIG. 5 is an embodiment of the prosthesis system further comprising one or more tensioning elements that form a lacing system which runs through tensioning anchors on the modular linkages and the tensioner.

[0014] FIG. 6 shows cross-sectional views of an embodiment of a major modular linkage from top and side views.

[0015] FIG. 7 shows cross-sectional views of an embodiment of a minor modular linkage from top and side views.

[0016] FIG. 8 shows isometric views of an embodiment of a minor modular linkage.

[0017] FIG. 9 shows isometric views of an embodiment of a major modular linkage.

[0018] FIG. 10 shows a close-up cross-sectional view of an embodiment of a modular linkage comprising a tensioning anchor.

[0019] FIG. 11 shows an exploded view of embodiments of individual components of a minor modular linkage including a frictional element and sensor.

[0020] FIG. 12 shows an exploded view of embodiments of individual components of a major modular linkage including a frictional element and sensor.

[0021] FIG. 13 shows isometric views of an embodiment of a network of repeating and interconnecting modular linkages.

[0022] FIG. 14 shows top and bottom views of an embodiment of a functional modular device with curved members and hollow linking channels.

[0023] FIG. 15 shows embodiments of two modular linkages linked together with the beam and curved member of a modular linkage inserted into the hollow linking channel of another modular linkage.

[0024] FIG. 16 shows isometric and cross-sectional views of embodiments of two modular linkages linked together with the only the curved member of a modular linkage inserted into the hollow linking channel of another modular linkage.

[0025] FIG. 17 shows an embodiment of a solid mechanical coupling element that may connect to a prosthesis on one side and a plurality of modular linkages on the other.

[0026] FIG. 18 is an embodiment of the disclosed prosthesis system in which the socket connects to a solid mechanical coupling element.

[0027] FIG. 19 shows an embodiment of the outer load-sharing structure around a socket comprising modular linkages.

[0028] FIG. 20 shows an embodiment of a major modular linkage linked with two other modular linkages, with the beam and curved member of one modular linkage inserted into one hollow linking channel and only the curved member of a second modular linkage inserted into its other hollow linking channel.

[0029] FIG. 21 shows isometric, top, and cross-sectional views of an embodiment of the modular linkage's range of motion and the asymmetric nature of a notch.

[0030] FIG. 22 shows isometric, top, and cross-sectional views of an embodiment of modular linkages with no beams.

[0031] FIG. 23 shows an embodiment of the disclosed prosthesis system further comprising a sensor system and processing unit.

DETAILED DESCRIPTION OF PREFERRED EMBODIMENTS

[0032] The following disclosure provides various embodiments of the disclosed invention to enable a person skilled in the art to make and use the invention exemplified in the embodiments. However, these embodiments are merely examples to simplify the disclosure and are not intended to be limiting.

[0033] The disclosed invention is an adjustable prosthesis system 100. FIG. 1 shows an embodiment of the prosthesis system comprising repeating and interconnecting modular linkages 110. The modular linkages may be configured to form a socket that wraps around the limb of a user 200. This embodiment further comprises a mechanical coupling element 310/1710 which joins the socket to a prosthesis (prosthetic limb) by attaching to the prosthesis on one side 1720 and to a plurality of modular linkages on the other 1730. The prosthesis system comprises one or more tensioning elements 510 which may secure the plurality of modular linkages to the user's limb. One or more tensioners 520 are attached to the tensioning elements to allow the user to adjust the system's tension without clinical assistance.

Modular Linkages

[0034] The modular linkages are a novel structure that can be configured in a number of ways to create an adjustable custom socket for the user. An embodiment of the prosthesis system comprises of minor modular linkages 810 and major modular linkages 910. In this embodiment, illustrated in FIGS. 8 and 11, minor modular linkages comprise of a central tube 1110, a minor solid sector 1120 extending from and wrapping around approximately one-third of an exterior side of the central tube, a beam 1130 extending from the diametrically opposite exterior side of the central tube, and a curved member 1140 arcing from one radius line of the minor solid sector's end, through the beam's lateral end, to the other radius line of the minor solid sector's end. As illustrated in FIGS. 9 and 12, major modular linkages may comprise of a central tube 1210, a major solid sector 1220 extending from and wrapping around approximately two-thirds of an exterior side of the central tube, a beam 1230 extending from the diametrically opposite side of the central tube, and a curved member 1240 arcing from one radius line of the major solid sector's end, through the beam's lateral end, to the other radius line of the major solid sector's end. FIGS. 6 and 7 show a cross-sectional top view of a major 600 and minor 700 modular linkage. In this embodiment, the modular linkages are symmetric about the “A” axis 610/710. FIG. 22 illustrates other embodiments of modular linkages which may vary the number of beams 2200 and curved members to allow for variation in the number of interconnecting linkages. Furthermore, embodiments of modular linkages are not limited to symmetrical or circular shapes. For example, a modular linkage may comprise of a straight member instead of a curved member to achieve a triangular configuration. A user can then select the modular linkage most appropriate to achieve their desired socket configuration.

[0035] An embodiment of the minor modular linkage consists of a hollow linking channel 1150 that runs along the minor solid sector. As illustrated in FIGS. 15, 16, and 20, the hollow linking channel may be configured so that another modular linkage may be connected by inserting either the curved member of another modular linkage alone 1610 or the curved member and beam of the other modular linkage 1510. An embodiment of the major modular linkage may consist of two hollow linking channels 1250 that run along the major solid sector. This allows two modular linkages to insert into a major modular linkage 2010. Other embodiments of the modular linkages may incorporate a different number of hollow linkage channels allowing for variation in the number of interconnecting linkages. Furthermore, the hollow linking channels may contain a directionally biased snapping mechanism to link modular linkages once they are inserted. The direction and axis of insertion 1510/1610 may be orthogonal to the direction and axis of linkage 2110. This permits a maximum load that is greater than the force required to link the modular linkages because the direction of insertion is different than the direction of linkage. For example, the maximum load is higher in an embodiment where modular linkages insert horizontally but link vertically. A more detailed discussion on the range of motion of a modular linkage is described below.

[0036] The disclosed adjustable prosthesis system provides a cost-effective and easy-to-use means of adjusting the size and shape of the socket to correspond with changes in the user's limb. The modular linkages may be assembled in any number of configurations to fit the user's limb negating the need for the socket to be remolded, remanufactured, realigned, and refit if a user's limb changes in size. Instead, individual modular linkages easily integrate and separate allowing for seamless changes in the socket's length, scale, or shape to accommodate changes to the user's limb. Users do not need to see a prosthetist every time an adjustment is needed, and prosthetists do not have to undergo a labor-intensive adjustment process in the event they do.

[0037] In addition, modular linkages are designed to be cost effective. Modular linkages are discrete repeating units that make up the disclosed prosthesis system. In some embodiments a modular linkage can be constructed of one or more of acrylonitrile butadiene styrene, poly ether ketone, polyetherketoneketone, polyetherimide, acrylonitrile styrene acrylate, polyethylene terephthalate, polycarbonate, polylactic acid, and other material known or used by those skilled in the art. An embodiment of a modular linkage may be constructed from an injection mold allowing for mass-production. An embodiment of a modular linkage measures 23 mm in diameter but embodiments may range in size from 5 mm to 40 mm in diameter. Consequently, modular linkages may have a low cost per unit because they require little material to make. Moreover, each individual modular linkage is asymmetric in design, giving rise to anisotropic global behaviors for the assembled socket, allowing it to serve multiple different functions. For example, a modular linkage also controls the rigidity and range of motion of the socket. This is described in more detail below. In sum, the modular linkages can be mass-produced to be sold at very low cost and assembled with little to no expert assistance.

[0038] An embodiment of the mechanical coupling element comprises of interconnecting modular linkages 310 as illustrated in FIG. 3. In other embodiments, like the one illustrated in FIGS. 17 and 18, the mechanical coupling element may comprise of a solid element 1710. One side of the mechanical coupling element will connect to the network of modular linkages 410/1730 that comprise the socket using the same linking mechanism as individual modular linkages. For example, a curved member alone or a curved member and beam from the mechanical coupling element can be inserted into the hollow linking channels of a plurality of modular linkages that comprise the socket 410. The other side of the mechanical coupling element will connect to the prosthesis using coupling mechanisms known to persons of ordinary skill in the art 1720.

Elements Controlling the Prosthesis System's Fit

[0039] In some embodiments, such as the one illustrated in FIG. 5, the prosthesis system comprises of tensioning elements 510 to secure the modular linkages to the user's limb. The tensioning elements together may comprise a lacing system that wraps around the socket. FIG. 5 illustrates an embodiment of a modular linkage that further comprises of tensioning anchors 1010 which pass through from the medial side of the modular linkage to the side distal to the user's limb. Tensioning anchors permit guidance of a tensioning element through a center of the tensioning anchor so as to create an adjustable suspension. In turn, this permits the tension element to slide as its length changes, resulting in greater or lesser hoop stress and circumferential pressure on the user's limb. As illustrated in FIG. 5, the tensioning elements are attached to a tensioner 520 which is configured to allow the user to adjust the tension. In an embodiment, the tensioner may be configured as a ratcheting dial. The tensioning system offers multiple advantages in that it allows the user to adjust the socket's fit without clinical assistance. Moreover, a user requires only one hand to adjust the tension which negates or reduces the need for another individual's assistance. In some embodiments, the tensioning elements can be constructed of one or more of stainless-steel tensioning cable, other metal wire, string, nylon, or flexible plastic.

[0040] FIGS. 11 and 12 illustrate embodiments where a friction element 1160/1260 partially overlaps the central tube and fully overlaps the minor or major solid sector of the modular linkage. In another embodiment, the central tube is configured to allow the connection of a replaceable friction element medial to the user's limb via an insertable member that fits into the central tube. The friction element may comprise of one or more of silicon, polyurethane, rubber, or any material known or used by those having skill in the art. The friction element may be configured to distribute load and reduce how tight the socket must be configured to a user's limb. The friction element provides friction between the modular linkage and the layer below the friction element. In some embodiments this layer may be the user's skin. In others the prosthesis system comprises of a sleeve or conformal undercoating between the user's limb and modular linkage to reduce contact pressure. Therefore, the material should be soft and have a high coefficient of friction. The undercoating may be constructed of one or more of foam, rubber, silicone, polyurethane, and other materials that reduce contact pressure. The friction element and undercoating allow the socket to remain in place around the user's limb and provide a form of padding to reduce pressure from the socket on the user's skin.

[0041] FIG. 19 illustrates an embodiment of the disclosed system further comprise an outer load-sharing structure 1910 that redistributes load across the socket to increase the load-bearing capacity of the prosthesis system. This would make the socket more rigid and prevent the prosthesis from buckling. In an embodiment, the outer load-sharing structure may also be configured to secure the socket to the limb so that a tensioning element isn't needed. Furthermore, in some embodiments the outer load-sharing structure may also function as a covering over the prosthesis which a user can customize and replace.

[0042] Current prosthesis systems must be carefully molded by a prosthetist to comfortably fit a user's limb and require the use of padding liners for comfort. The disclosed system offers more versatile and granular means of achieving such comfort. The prosthesis system can be used with friction elements alone or with a sleeve. In addition, the user can use the tensioning system to adjust tension across the socket. The tensioning system allows the socket to adapt to volumetric fluctuations in the size of a limb without the need to add or remove padding liners. Finally, the outer load-bearing structure can also reduce contact pressure.

Elements Controlling the Prosthetic System's Range of Motion

[0043] The configurable and asymmetric nature of modular linkages allows a user or prosthetist to control the range of motion of the prosthesis system. The linkage of several modular linkages, when assembled in a specific and engineered configuration, results in the formation of a metamaterial, whereby the material as a whole behaves very differently than each component would behave on its own. The insertion of a first modular linkage into a second modular linkage via the directionally biased snapping mechanism with both the curved member and beam, restricts the range of motion of the interconnecting modular linkages to zero degrees of freedom. If the modular linkages are linked using only a curved member, the interconnecting modular linkages retain one degree of freedom, the yaw. In a three-dimensional plane this refers to movement about the Y-axis. Therefore, the number of beams in a modular linkage may control the range of motion within a configured socket. Some embodiments of the modular linkages further comprise of notches 1520 located at diametrically opposite ends of the hollow linking channels, as illustrated in FIG. 15. These notches allow for additional range of motion. When a modular linkage with notches is linked via a curved member alone, the interconnected modules have a second degree of freedom, the pitch, 2110 as illustrated in FIG. 21. On a three-dimensional plane this refers to movement about the X-axis. However, the asymmetric nature 2120 of the notches limits these modular linkages to either pitch-up or pitch-down motion. Embodiments of notches may vary in size and position to allow for varying ranges of motion. Collectively, these features allow the user or prosthetist to configure the prosthesis system based on the needs of the user. For example, some users might prefer additional range of motion in the socket, while others prefer a more rigid structure. If the user's preference changes, they can easily reconfigure the prosthesis system. This control over range of motion permits formation of different global mechanical properties for the socket, either in part or in whole. Some configurations of modular linkages would give rise to tight radii of curvature and low stiffness, while other configurations would give rise to straight and stiff sections. The disclosed invention allows for a wide range of socket mechanical properties, variable within user-defined regions of a single socket, to be composed from a single material with very low unique part count.

Functional Elements

[0044] The prosthesis system may be configured to connect to a functional element 2320. Functional elements may include one or more of GPS tracking device, interactive display, personal cellular phone, motor, batteries, data storage and communication device, graphical user interface, buttons, microphone, speaker, processing unit, and other elements known or used by a person skilled in the art. In some embodiments the prosthesis system attaches to a functional element through a functional module dock, 1410 as illustrated in FIG. 4. In others, the functional element may attach without the use of a dock. An embodiment of the functional module dock comprises of repeating curved members 1420 and hollow linking channels 1430 along the exterior edge of the dock. This allows the functional module to connect to modular linkages using the same directional snapping mechanism described above. Integration of functional elements with the prosthesis system provides users with more functionality and cam allow clinicians to monitor patients more closely.

[0045] Embodiments of the modular linkages further comprise a central tube that is configured to contain a sensor 1170/1270 medial to the user's limb. FIG. 23 illustrates an embodiment of the disclosed prosthesis system configured with a sensor system. The plurality of wires 2310 of the sensor system run through the central tube and out the distal side of the central tube. The sensor system communicates with a processing unit 2320 to collect user data. For example, data may include the user's heart rate, temperature, blood pressure, and the prosthesis angle and moment. The disclosed sensor system improves on currently available systems because it may be mass-produced at low cost, requires little customization, and significantly reduces the effort and skill prosthetists require to implement such system. Furthermore, the modular and repeating nature of the socket assembly provides a system by which sensors and stimulating elements can be selectively and precisely located and relocated along the user's limb without the need to embed these elements in the socket during manufacture. This permits the disclosed prosthesis system to be modified over time without the need to manufacture a new socket. In some embodiments the processing unit is a system for data storage. In others the processing unit allows for data analysis and communicates results to a user's clinical provider or the user themself. Furthermore, an embodiment of the sensor system incorporates artificial intelligence to analyzes and learn from data collected by the sensor system.

[0046] In some embodiments the central tube further comprises a stimulating element that is controlled by a processing unit on the basis of input received at the sensor system. Individuals often have a hard time learning how to use a prosthetic limb because they are unable to experience sensations in the prosthesis. Some even experience phantom limb syndrome where they “feel” their missing limb in a perceived position different from the prosthesis. Consequently, a user requires a lot of time to learn how to operate a prosthesis. The stimulating element addresses these issues by stimulating a user's residual limb based on input from the sensor system. This allows for a more natural approach to sensory learning which enables users to engage with prostheses more closely and master use of them more efficiently. In addition, a clinical expert may utilize the stimulating element to assist with a patient's physical therapy.

[0047] A person skilled in the relevant art will recognize that other configurations and arrangements can be used without departing from the spirit and scope of the disclosed invention. It will be apparent to a person skilled in the relevant art that this invention can also be employed in a variety of other systems and applications.