This application is a U.S. National Entry and claims priority to PCT International Patent Application No. PCT/EP2018/078232, filed 16 Oct. 2018, and entitled “ORTHOPEDIC DEVICE AND CONDUCTOR FOR SUCH A DEVICE”, which claims priority to Germany Patent Application No. 10 2017 126 465.5 filed 10 Nov. 2017, the entire disclosures of which are incorporated herein by this reference.
The invention relates to an orthopedic device with a base body made of an electrically insulating material and at least one electric conductor which is arranged on or in the base body. The invention also relates to a conductor for such an orthopedic device and a method for producing such a conductor.
Within the scope of the present invention, orthopedic devices are specifically orthoses, prostheses, especially prosthesis sockets and prosthesis liners, or other rehabilitation devices. Nowadays, orthopedic devices are often equipped with electrodes in order to pick up and transmit myoelectric signals to a data processing device or to conduct electric stimulation signals to the skin and/or an underlying muscle thereof of the patient, i.e. the wearer of the orthopedic device. This is particularly advantageous in the case of the prosthesis liners, as they come into direct contact with the skin of the wearer and are thus especially well-suited to bear corresponding electrodes. Of course, the present invention is not limited to prosthesis liners.
A series of different electrodes is known from the prior art, wherein said series of electrodes can be brought into contact with the skin of the wearer of the orthopedic device. These may be arranged, for instance, on the inner side of the orthopedic device, such as the prosthesis liner, i.e. in direct contact with the skin, or positioned on the outer side of the liner, for example on the inner side of a prosthesis socket surrounding the liner. In this case, the liner often has electrically conductive through-lines, for instance in the form of metal rivets, or electrically conductive silicone areas, such that the orthopedic device has been rendered electrically conductive in the area around the electrodes.
However, it is disadvantageous that in this case the electrodes must be arranged precisely at the point at which the through-lines are arranged in the orthopedic device as well as precisely at the point at which they must be arranged on the wearer, for example on an amputation stump. These electrodes, which often require a lot of space, can therefore often not be arranged at the optimum point.
The prior art thus describes a series of different possibilities for arranging electrical conductors in or on the base body made of electrically insulating material. For instance, it is known to use silver fabric to conduct electric signals through the base body of the orthopedic device to a further processing point, such as an electronic data processing device. However, the disadvantage of using silver is that it is highly susceptible to corrosion; it also does not possess sufficient elasticity. This is especially disadvantageous if the conductor produced in such a manner is arranged in an orthopedic device which itself is made of an elastic material.
Therefore, DE 10 2014 106 070 A1 describes a method in which a prosthesis liner is equipped with electrically conductive conductors. First, the base body is produced from an electrically insulating elastomer material. Said material is crosslinked. Structures are then inserted into the first formed elastomer material; said structures serve as a mould for the electrical cables. A second elastomer material is subsequently inserted into these structures and then cross-linked, said material being electrically conductive. In this way, an electric conductor is produced from an electrically conductive elastomer material; said conductor is arranged in recesses in the base body.
However, it is disadvantageous that this method only allows for the arrangement of electrically conductive structures in a surface of the base body, and that it is complex and therefore time-consuming and expensive.
The invention therefore aims to further develop an orthopedic device according to the generic term in claim 1 in such a way that electric conductors can be arranged especially easily in or on the base body and elastic properties of the base body are not adversely affected.
The invention solves the problem by way of an orthopedic device according to the present disclosure, wherein the at least one conductor comprises a core made of an electrically conductive elastomer and an electrically insulating coating.
This type of conductor may be provided in the form of a cable or cord, for example. The elastomer of the core may be rendered electrically conductive through the addition of particles, for instance. A coating made of electrically insulating material is applied to core shaped in this manner, for example in the form of the aforementioned cord or cable. Here, the coating preferably does not have an adverse effect on the elastic and flexible properties of the core, so that they correspond to the elastic and flexible properties of the electric conductor. This conductor can now be easily arranged in or on the base body of the orthopedic device; for example, it can be cast into an elastomer material of a prosthesis liner. In this case, as both the core of the electric conductor and the electrically insulating material of the base body are elastomers, elastic properties of the orthopedic device are also not adversely affected.
Preferably, an elastomer of the core is a silicone, a thermoplastic elastomer or a polyurethane, in which graphite, soot and/or metal particles and/or carbon nanotubes are found. Alternatively or additionally, conductive fibers may also be used.
The electrically insulating coating preferably contains or is made from a parylene. The use of parylene as an insulting coating has the additional advantage that it also functions as a bonding agent; this is particularly true when both the electrically insulating material of the base body and the electrically conductive elastomer of the conductor are a polyurethane or a silicone. The parylene coating not only enables an electrically insulating effect to be achieved, but it also ensures an effective bond between the material of the base body of the orthopedic device and the electric conductor.
The material of the base body preferably contains or is made of a silicone, a thermoplastic elastomer or a polyurethane.
Preferably, the orthopedic device comprises at least one electrode and/or at least one sensor, wherein the electrode and/or the sensor is electrically connected to the at least one conductor and is preferably arranged such that, when the device is mounted on a body part, it comes into contact with that body part. This enables a particularly effective contact for transmitting electrical signals and impulses; at the same time, it ensures that, even when the orthopedic device is subjected to high mechanical and/or thermal loads, a reliable transmission of the signals is guaranteed. The at least one sensor preferably features a pressure sensor, a temperature and/or moisture sensor, a pulse measurement and/or blood circulation measurement sensor (N IRS) and/or a sensor for measuring blood glucose levels.
Rather than arrange the electrodes and/or sensors on the skin of the wearer of the orthopedic device, a distance to the skin may be maintained if the electrode and/or the sensor works in a capacitive or inductive manner.
Preferably, the at least one conductor features a shielding made of an electrically conductive elastomer that is arranged on the side of the insulating coating that faces away from the core. The electric conductor is thus constructed in three layers from radially inwards to radially outwards and initially has a core of electrically conductive material, preferably an elastomer, which is covered by the electrically insulating coating on whose outer side the shielding is situated. It is thereby possible to produce a type of electric conductor shielded with a coaxial cable that does not have an adverse effect on the elastic and flexible properties, especially of a prosthesis liner.
The shielding preferably comprises or is made of the same material as the core of the electric conductor.
The invention also solves the task by way of a conductor for a prosthesis as described here. The invention also solves the task by way of a method for producing such a conductor, wherein the coating is produced by a CVD process. The abbreviation CVD stands for “chemical vapour deposition” and describes a chemical coating process that experts know from the prior art.
In the following, an example of an embodiment of the present invention will be explained in more detail by way of the attached figures:
In the left-hand representation,
The central representation in
The right-hand representation in
Number | Date | Country | Kind |
---|---|---|---|
10 2017 126 465.5 | Nov 2017 | DE | national |
Filing Document | Filing Date | Country | Kind |
---|---|---|---|
PCT/EP2018/078232 | 10/16/2018 | WO |
Publishing Document | Publishing Date | Country | Kind |
---|---|---|---|
WO2019/091713 | 5/16/2019 | WO | A |
Number | Name | Date | Kind |
---|---|---|---|
4092985 | Kaufman | Jun 1978 | A |
20060111792 | Shannon | May 2006 | A1 |
20090216339 | Hanson et al. | Aug 2009 | A1 |
20090255706 | Jiang et al. | Oct 2009 | A1 |
20100044075 | Weiss et al. | Feb 2010 | A1 |
20100114238 | Muccio | May 2010 | A1 |
20130046394 | Lipschutz et al. | Feb 2013 | A1 |
20130166009 | Branemark | Jun 2013 | A1 |
20140188251 | Mosler | Jul 2014 | A1 |
20150257315 | Wagner et al. | Sep 2015 | A1 |
20160038314 | Kuiken | Feb 2016 | A1 |
20170333223 | Rasmussen | Nov 2017 | A1 |
20180296822 | Schroeder | Oct 2018 | A1 |
20180297214 | Lessing | Oct 2018 | A1 |
20190167976 | Byers | Jun 2019 | A1 |
20190254845 | Wernke | Aug 2019 | A1 |
20200289295 | Koppe | Sep 2020 | A1 |
20220031480 | Bause | Feb 2022 | A1 |
Number | Date | Country |
---|---|---|
201004344 | Jan 2008 | CN |
101548576 | Sep 2009 | CN |
101556839 | Oct 2009 | CN |
103702638 | Apr 2014 | CN |
104684477 | Jun 2015 | CN |
102014106070 | Nov 2012 | DE |
102011101583 | Nov 2015 | DE |
2737878 | Jun 2014 | EP |
WO2014052080 | Apr 2014 | WO |
Entry |
---|
Chou et al., “Deposition, characterization, and in vivo performance of parylene coating on general-purpose silicone for examining potential biocompatible surface modifications,” Thin Solid Films 549, 2013, pp. 103-107, 6 pages. |
“International Search Report and Written Opinion of the International Searching Authority,” issued in connection with Int'l Appl. No. PCT/EP2018/078232, dated Dec. 20, 2018 (19 pages). |
Chinese Patent Office, “Search report,” issued in connection with Chinese Patent Application No. 201880071957.1 dated Nov. 22, 2022 (2 pages). |
Number | Date | Country | |
---|---|---|---|
20200289295 A1 | Sep 2020 | US |