MANUFACTURING SOCKET OF LOWER AND UPPER LIMB PROSTHESES

Abstract

A system for creating a prosthesis includes a deformable measuring bag fillable with beads or pellets, an air evacuation tube coupled to the deformable measuring bag and connectable to a vacuum source, supports coupled to the deformable measuring bag for supporting the deformable measuring bag, and a connection element for connecting the deformable measuring bag to a prosthetic limb.

Claims

1. A system for creating a prosthesis comprising: a deformable measuring bag; an air evacuation tube coupled to said deformable measuring bag and connectable to a vacuum source; supports coupled to said deformable measuring bag for supporting said deformable measuring bag; and a connection element for connecting said deformable measuring bag to a prosthetic limb.

2. The system according to claim 1, wherein said deformable measuring bag comprises an inner portion and an outer portion.

3. A method for creating a prosthesis using the system of claim 1, the method comprising: filling the deformable measuring bag with a hardenable material; connecting a lower portion of the bag to a prosthetic limb; inserting a stump of a residual limb of a patient into an upper portion of the deformable measuring bag; pressing the deformable measuring bag against the stump to ensure a uniform and controllable pressure at all contact points of the deformable measuring bag with the stump; sucking air out of the deformable measuring bag by vacuum to set a shape of the bag, during which the patient can apply different loads while walking or standing; allowing the hardenable material to harden in the bag and form a negative mold; pouring a hardenable substance into said negative mold and allowing said hardenable substance to harden to form a positive mold; extracting said positive mold and scanning said positive mold to create a 3D computer file; and printing a prosthetic socket using said 3D file.

4. The method according to claim 3, comprising using sensors to sense pressure between the stump and the bag.

5. The method according to claim 3, comprising adding pressure release points for pressure sensitive areas on the stump.

6. A method for creating a prosthesis comprising: taking measurements of a shape of a residual limb of a patient while the patient puts loads on the residual limb with the patient being both stationary and in motion; and forming a socket of a prosthesis based on said measurements.

Description

BRIEF DESCRIPTION OF THE DRAWINGS

[0018] The present invention will be understood and appreciated more fully from the following detailed description taken in conjunction with the drawings in which:

[0019] FIG. 1 is a simplified pictorial illustration of a measuring system in accordance with a non-limiting embodiment of the present invention, including a deformable measuring bag with holding structure and connection to the lower part of the prosthetic limb.

[0020] FIG. 2 is an exploded illustration of the measuring system.

[0021] FIG. 3 is another illustration of the measuring system.

[0022] FIG. 4 is a simplified illustration of an example of a pressure release structure for pressure sensitive areas on the stump.

DETAILED DESCRIPTION OF EMBODIMENTS

[0023] Reference is now made to FIG. 1, which illustrate a measuring system, constructed and operative in accordance with a non-limiting embodiment of the present invention.

[0024] The measuring system may include upper connection rings 11, which seal the two parts of a deformable measuring bag 13 and connect it to a measuring jig. An air evacuation tube 12 enables creating a vacuum inside the deformable measuring bag 13. Tube 12 may include a valve for controlling the vacuum level. The deformable measuring bag 13 may be filled with beads or pellets.

[0025] Vertical movable supports 14 may be provided for supporting the deformable measuring bag 13 during the measuring/simulating process. Adjusting elements 15 may be provided for adjusting the vertical supports 14 of the deformable measuring bag 13 during the measurement process.

[0026] A lower plate 16 may connect the measuring jig to the lower part of the prosthetic limb to enable full simulation during the measuring process.

[0027] Reference is now made to FIG. 2, which illustrates an exploded view of the system of FIG. 1. The system includes upper connection rings 11, which seal the two parts of the deformable measuring bag 13 and connect it to the measuring jigs. Air evacuation tube 12 is used to create a vacuum inside the deformable measuring bag 13. The deformable measuring bag 13 includes an inner portion 23 and an outer portion 24.

[0028] Reference is now made to FIG. 3, which illustrates deformable measuring bag 13 filled with beads or pellets, and which is placed under a residual limb 30 of the patient. The complete supporting structure of the measuring system includes the connecting plate 16 for attachment to a lower leg prosthesis 32, adjustable vertical supports (e.g., rods) and horizontal adjusting supports 31. The connecting plate 16 may include a flat washer for sealing the air inlet to the deformable measuring bag 13.

[0029] The invention can measure the shape of the residual limb 30 in a dynamic mode and under real loading conditions with the stump deformed to its standing, walking or working shape. This negates the need for guesswork about how the stump will change shape under stress. This process may be done using the measuring system as a simulator.

[0030] The residual limb 30 is inserted into the deformable measuring bag 13 containing small beads, for example, up to 1 mm in diameter, made of material of up to 60 Shore A hardness to capture the 3-dimensional shape of the individual stamp. The deformable measuring bag 13 is pressed from the outside using a circular pressure calf with a preset air pressure to ensure a uniform and controllable pressure at all contact points of the measured socket (i.e., the bag) with the stump. This process sets the pressure to an initial safe level to prevent any pressure related sores or discomfort. At this stage the air is sucked out of the deformable measuring bag 13 by vacuum through tube 12 to a preset vacuum (negative pressure) level in order to set the shape. The patient can apply full load on the measuring system and simulate all relative functions like walking, standing etc. In the second stage the outer pressure calf is removed, and the prosthetic technician can manually create additional pressure points or remove some pressure from different contact points to improve the fitting of the measured socket. This is performed by alternating the air pressure in the deformable measuring bag 13.

[0031] Prior to the measuring process the deformable measuring bag 13 is prepared by inserting some two-component resin that will harden the bag within a set time or activated by heat, thereby enabling a preset working time interval.

[0032] Once the time is up, the deformable measuring bag 13 hardens to the shape of the stump and creates a durable stable measured socket with the best fit.

[0033] The pressure between the stump and the socket can be controlled to achieve safe levels as well by indications from a set of sensors placed on the inner side of the deformable measuring bag 13. This presents to the prosthetic technician a visual pressure map of the contact between the socket and the stump.

[0034] Once the final shape of the socket is achieved the shape on the inner cavity created by the deformable measuring bag 13 can be copied to a positive shape using a two component or one component expanding material. This material is poured into the cavity and expands to totally fill the entire space. Once the material hardens it is extracted from the deformable measuring bag 13 and scanned using a 3D scanner to create a 3D file for the next stage of manufacturing the socket.

[0035] The expandable material has some elastic properties to simulate the actual stamp and enable to easily extract the created shape out of the deformable measuring bag 13.

[0036] As seen in FIG. 4, the designed socket can incorporate some specially designed shapes 40 to act as pressure release points for pressure sensitive areas on the stump.

[0037] The system may include a data collection system from patients to give technical advice to help the technician reach optimal clinical results.

[0038] Once this process is completed, one proceeds to the manufacturing stage. The manufacturing process begins with 3-dimensional scanning of the positive shape created in the previous stage using the expandable material. This 3D file can be presented using 3D design software. The software can enable the prosthetic technician to perform some minor needed changes and adaptations to the designed socket. The system can enable adding the pressure release elements as described above into specific areas on the designed socket.

[0039] The software and data base will enable the prosthetic technician to perform the best adaptation to the socket to achieve the optimal fit.

[0040] The software will enable the prosthetic technician to add any standard connecting element to the socket for connecting of any kind of a prosthesis.

[0041] The complete socket system is then 3D printed on a specially designed 3D printing system. The system is designed to print at low cost and different printing speeds using different size nozzles in an optimized format. The total printing time, without limitation, is less than 360 minutes for a complete socket.

[0042] Printing with a large nozzle creates a strong structure with some compromise of accuracy that will not affect the socket performance but will enable a significantly higher printing speed.