PROSTHESIS COVER FOR A PROSTHESIS, PARTICULARLY FOR A PROSTHETIC LEG
20220409405 · 2022-12-29
Inventors
Cpc classification
A61F2002/7837
HUMAN NECESSITIES
A61F2/7812
HUMAN NECESSITIES
International classification
Abstract
The present invention relates to a prosthesis covering with a closed cross-section which comprises a first section, a second section and a third section. The second section is arranged in longitudinal direction between the first section and the third section and comprises other material, other diameter and/or other circumference than one or both of the other two sections.
Claims
1. A prosthesis covering having a closed cross-section wherein the prosthesis covering comprises along its longitudinal extension at least a first section, a second section and a third section, wherein the second section comprises a larger circumference or diameter than both the first section and also the third section and/or wherein the second section is made of, or comprises, a material comprising a higher E-Modul (Young's modulus) than one or several of the materials of the first section and/or the third section, and wherein the second section is arranged between the first section and the third section.
2. The prosthesis covering according to claim 1, having a layer or outer skin which extends continuously over the first section, the second section and the third section, wherein the layer or outer skin is connected, in the first section and/or in the third section, but not in the second section, to an inner liner, preferably directly or indirectly and/or in the radial direction.
3. The prosthesis covering according to claim 1, wherein the first section, the second section and/or the third section is made of, or comprises, an airtight material.
4. The prosthesis covering according to claim 1, wherein the first inner liner and/or the second inner liner is made of, or comprises, silicone.
5. The prosthesis covering according to claim 1, wherein the first subsection of the second section or the outer skin is not elastic in a circumferential direction.
6. The prosthesis covering according to claim 1, wherein the first section and/or the third section are elastic.
7. The prosthesis covering according to claim 1, wherein the second section comprises at its inner side at least one ribbon-shaped structure as second subsection.
8. The prosthesis covering according to claim 1, wherein the second section is connected to the third section in a fastening section, and wherein the third section partially protrudes the second section beyond the fastening section towards s the first section by a protrusion of the third section, in which material of the third section is not connected to the second section.
9. A prosthesis, in particular leg prosthesis or knee prosthesis, which is at least partially covered or overlaid by a prosthesis covering according to claim 1.
10. A set having a prosthesis and a prosthesis covering according to claim 1.
11. A prosthesis covering, in particular according to claim 1, having a closed cross-section, wherein the prosthesis covering comprises along its longitudinal extension at least a first section, a second section and a third section, wherein the second section is made of, or comprises, a material comprising a higher E-Modul (Young's modulus) than one or several of the materials of the first section and/or the third section, and wherein the second section is arranged between the first section and the third section.
Description
BRIEF DESCRIPTION OF THE DRAWINGS
[0190] The present invention is exemplarily explained with regard to the accompanying drawing in which same reference numerals refer to the same or similar components. In the figures, the following applies:
[0191]
[0192]
[0193]
[0194]
[0195]
[0196]
[0197]
[0198]
[0199]
[0200]
[0201]
[0202]
[0203]
[0204] The prosthesis covering 100 comprises a first section 10, a second section 20 and a third section 30, or alternatively consists thereof. Its longitudinal direction or longitudinal axis is indicated with L. The prosthesis covering 100 extends in an axial direction. The transverse direction or the radial direction extends perpendicular to the longitudinal direction L.
[0205] Thereby, the second section 20 is arranged between the first section 10 and the third section 30. In the example of the figures the first section 10 and the third section 30 are not in contact with each other. As in
[0206] The second section 20 comprises a higher E-Modul (Young's modulus) than the first section 10 and/or than the third section 30.
[0207]
[0208] Thereby, in a first subsection 21 thereof, the second section 20 is folded lamella-like along its entire circumference. In
[0209] The lamellas serve as an example of a material reservoir, in particular in the longitudinal direction of the second section 20 (see the line L in
[0210] Hereby, the patient feels no pressure on the skin which would result from the tension of an elastic material in the second section 20. The second section 20 (in comparison to a lower Young's modulus of the first section 10 and/or the third section 30) does not allow such pressure to occur. Instead of building up pressure, it simply lengthens (extends) in the longitudinal direction due to the lamella-like structure provided therefore.
[0211]
[0212] It is visible, that the material of the first subsection 21 of the second section 20, which is folded in lamellas, lies on top of each other due to a double over. In the state of the prosthesis covering 100 shown in
[0213]
[0214] The prosthesis covering 100 differs from the one in
[0215] The second subsection 22 connects the first section 10—directly or indirectly—with the third section 30. It may ensure that the distance between the first section 10 and the third section 30 (in longitudinal direction L) does not exceed a maximum distance or a desired maximum distance. It may further ensure that the material reservoir of the second section 20 does not unfold while the prosthesis covering is being pulled on or put on and is no longer available to the patient during later flexion movements.
[0216] Unlike the first subsection 21, the length or the visible or unfolded length of which may be increased by unfolding, the second subsection 22 does not comprise a material reserve. Its length is unchangeable, however, within its elasticity or its non-elasticity.
[0217] Thereby, the second subsection 22 may be less elastic in comparison to the elasticity of the first section 10 and/or the third section 30. It may optionally be non-elastic. The same applies to the second section 20 in longitudinal direction, which is, due to the second subsection 22, less elastic than the first and/or the third section 10, 30.
[0218] In
[0219] Also, the width of the second subsection 22 may vary. In
[0220] The second subsection 22 preferably rests loosely on the first subsection 21 in at least one section (on the outside or the inside of the first subsection 21). In this section in which it rests loosely, it is not for example glued or sewn or otherwise connected to the underlying first subsection 21.
[0221] The loosely resting section can be 30%, 40%, 50%, 60%, 70%, 80% or more of the length or the visible length of the second subsection 22.
[0222] Due to the fact that the aforementioned section of the second subsection 22 rests loosely on the first subsection 21, e.g. a finger or a flat hand may be pushed through between the second subsection 22 and the first subsection 21. This embodiment allows the first subsection 21, which lies under the second subsection 22, to unfold freely at least in the area of the loosely resting section, should this be necessary when wearing the prosthetic covering 100. The relative movement between the second subsection 22 and the first subsection 21, made possible by the loosely resting section, contributes advantageously to said free unfolding.
[0223] Although it is mentioned above that the second subsection 22 rests on the first subsection 21, this is not intended to restrict the invention (as shown in
[0224]
[0225] In
[0226] The drawing ruler 50 is pushed or slid through under the second subsection 22 and above the first subsection 21. The loosely resting section, i.e. that section in which the first subsection 21 is not connected to the second subsection 22 by a material connection (gluing, textile welding or the like) or by a force-fit or form-fit connection (stitching, hook-and-loop fastener or the like) or connected in any other way, permits such a push-through.
[0227] It has been shown through non-public experiments by the inventor that a loose section can significantly improve the comfort of the patient or user of the prosthesis covering.
[0228]
[0229] It can be seen that the wall thickness of the first section 10 can optionally be thicker in an area 11 than in adjacent areas, wherein the area 11, for example when the prosthesis covering 100 is worn, may face forward (ventrally).
[0230]
[0231] As can be seen from
[0232] If this protrusion 31 of the third section 30 is not connected (glued, sewn, etc.) in whole or in sections to the second section 20, to the first subsection 21 and/or to the second subsection 22, it can be cut or trimmed to size by the user of the prosthesis covering 100 in a simple manner in order to suit their needs. For example, the protrusion 31 may be trimmed along a cut line 40 which is to be determined by the user e.g. in order to fit the upper edge of a prosthesis.
[0233] This is shown in
[0234] It does not matter whether the fastening section 32, in which the second section 20 or its subsections 21, 22 are connected to the third section 30, extends to a lower end of the third section 30 or is merely a strip or otherwise shaped area beyond which the third section 30 is in turn not connected (glued, welded, etc.), e.g. downwardly with respect to
[0235] It is further encompassed by the present invention that the protrusion 31 of the third section 30 abuts the second section 20 externally or internally, which may apply to any embodiment.
[0236]
[0237] In
[0238] In
[0239]
[0240] The second subsection 22, which is also shown on the outside in
[0241]
[0242] In the sixth embodiment, the prosthesis covering 100 comprises a layer extending over all three sections 10, 20 and 30, which covers the prosthesis covering 100 here on its outer side, which is why it is referred to herein—not restrictively—as outer skin 101. In other embodiments than the one shown here, this layer extending in a longitudinal direction of the prosthesis covering 100 over all sections 10, 20 and 30 completely or at least in sections, respectively, may be present on an inner side or in a central area of the wall of the prosthesis covering 100 (relative to its thickness or material thickness) instead of being present on the outside.
[0243] Although the outer skin 100 ends, as an example of the aforementioned layer, at the proximal as well as at the distal end of the prosthesis covering 100 in the exemplary embodiment shown in
[0244] The first section 10 comprises an inner liner 13 on the inside of the aforementioned outer skin 101 or consists of the outer skin 101 and the inner liner 13. The position of the outer skin 101 and the inner liner 13 relative to each other, according to which the outer skin 101 rests, as its name suggests, on the outside of the inner liner 13 is as mentioned above, however, only exemplarily. Alternatively, the material or element referred to herein as inner liner 13 could rest on the outside of the outer skin 101 and/or radially with respect thereto. The latter would then be an inner skin, and the inner liner 13 rather a sheathing, so to speak.
[0245] The inner liner 13 may be cylindrical (by appropriately holding the prosthesis covering), or it may be a differently shaped hollow body with a through-direction in the longitudinal direction of the prosthesis covering.
[0246] The inner liner 13 may be circumferential or closed, and it may optionally have a length that is greater than its wall thickness or its average wall thickness.
[0247] For example, the inner liner 13 may be or comprise silicone, or may be or comprise another material. The inner liner 13 may be designed to advantageously conform for example to the patient's skin in a smooth and preferably airtight manner.
[0248] The wall thickness of the inner liner 13 in a non-stressed state of the prosthesis covering may be for example in a range from 3 mm to 5 mm, preferably 4 mm.
[0249] The outer skin 101 or its material may be airtight. It may be, optionally, a membrane fabric. It may optionally be two-, three- or multi-layer.
[0250] In particular, the outer skin 101 and the inner liner 13 may be of different materials.
[0251] Outer skin 101 and inner liner 13 may be glued or otherwise connected to each other in the area of the first section 10. The gluing or other connection may extend along the entire length of the first section 10 or over only a section thereof (in the longitudinal direction of the prosthesis covering).
[0252] Incorporated into this connection or gluing may be an end section of the subsection 22, which may have or be, for example a lateral ribbon as described herein (right in
[0253] Exemplarily, the outer skin 101 does not comprise a circumferential seam over its entire length, but at least in the transitions between the first and second sections 10, 20 and/or between the second and third sections 20, 30, which may be associated with manufacturing and durability advantages.
[0254] The outer skin 101 may thus—at least in the longitudinal direction—be of continuous design made of an uninterrupted textile, such a membrane, foil, etc.
[0255] In some arbitrary embodiments, such as that of
[0256] It can be seen that in this embodiment the outer skin 101 has at least two diameters and/or circumferences, namely a first diameter and/or circumference in the area of the first section 10 and a second diameter and/or circumference in the area of the second section 20, wherein the first diameter and/or circumference is smaller than the second.
[0257] When reference is made herein to the first diameter or circumference being smaller than the second diameter or circumference, this may refer to a relaxed state of the prosthesis covering 100, such as when the prosthesis covering 100 is not being worn but is, for example, still in the closet or packaging.
[0258] The first diameter or circumference may e.g. therefore be smaller than the second diameter or circumference because for manufacturing the prosthesis covering 100 less material was used for the outer skin 101 in the area of the first diameter/circumference than in the area of the second diameter, and the circumference is thus smaller with the same wall thickness.
[0259] However, the first diameter or circumference may e.g. also therefore be smaller than the second diameter or circumference because for manufacturing the prosthesis covering 100, the outer skin 101 was permanently pre-stretched in the area of the second diameter or circumference, unlike in the area of the first diameter or circumference. The pre-stretching may involve plastic deformation, which is why the outer skin 101 may have a smaller wall thickness in the area of the second diameter or circumference than in the area of the first diameter or circumference.
[0260] The first diameter or circumference may also therefore be smaller than the second diameter, because when manufacturing the prosthesis covering 100, the outer skin 101 was doubled or placed in waves in the area of the first diameter or circumference and connected in this state, for example glued, to the inner liner 13 and/or 33. In this way, the outer skin 101, were it to be released from its connection or gluing and subsequently smoothed, would have a first circumference in the area of the first diameter which is or may be as large as the second circumference. In the connected state, i.e. when the prosthesis covering 100 is manufactured, as shown for example in
[0261] The choice of different diameters or circumferences results in or leads to a shape of the prosthesis covering 100 as shown in
[0262] As in other embodiments disclosed herein, the subsection 22 may ensure that the distance between the first section 10 and the third section 30 (in the longitudinal direction L) does not exceed a maximum distance or a desired maximum distance between the first section 10 and the third section 30.
[0263] In this, the second section 20 is preferably, due to its subsection 22, less elastic than the first section 10 and/or than the third section 30. It may optionally be non-elastic, particularly with respect to its second subsection 22.
[0264] What is set forth herein for the inner liner 13 or the first section 10 may apply undiminished also for an inner liner 33, which is optionally shown on an inner side of the outer skin 101 in the area of the third section 30 in
[0265] Unlike the first section 10 and/or the third section 30, the second section 20 preferably does not comprise an inner liner, in particular not in the sense of the inner liner 13 or 33.
[0266]
[0267] As can be seen from
[0268] Purely optionally, the prosthesis covering 100 of
[0269] In particular, the prosthesis covering 100 of
[0270] Further, the prosthesis covering 100 of
[0271] Thus, the inner liner 13 in
[0272] The wavy outer surface may be glued to the outer skin 101 such that it is also wavy in those areas in which it is for example glued to the inner liner 13 or 33. This is different in the free area, i.e. where the outer skin 101 is not glued as described above. There it may lie free of waves, hence, this is the reason why the outer skin 101 has a smaller diameter (see
[0273] The maximum circumference in the area of the first section 10 and/or in the area of the third section 30 is, for example, 20 cm, while the maximum circumference in the area of the second section 20 is, for example, 50 cm.
[0274] As can be seen from the upper or proximal section of the inner liner 33 shown by the dashed line, the inner liner 13 or 33 may be only partially connected or glued to the outer skin 101. A section of the inner liner 13, 33 may be free from gluing.
[0275] The optional subsection 22 of
[0276] In some embodiments, the outer skin 101 is the first subsection 21. What is set forth herein for the outer skin 101 may apply undiminished to the first subsection 21, and in several embodiments, the reverse is also true.
[0277]
[0278] The prosthesis covering 100 corresponds to the one shown in
[0279] The first subsection 21 may be optionally supplemented to 360° with the second subsection 22, as shown by way of example in
[0280] The first subsection 21 may cover optionally 360° of the circumference of the extremity or of the prosthesis covering 100. The second subsection 22 may lie on or adjacent to the first subsection 21, optionally at its inner or outer surface.
[0281] As shown in
[0282] In any embodiment according to the present invention, the first subsection 21 may cover between 40% and 70% of the circumference, more preferably a part of the circumference, constituting between 55% and 65% of the circumference, most preferably 60% of the circumference.
[0283] The percentages mentioned above may optionally refer to the unstressed state of the prosthesis covering 100, for example, before use, e.g. in the shipping packaging, or it may refer to a state of use, for example, on the extremity.
[0284]
[0285] Only the second section 20 is cut and unfolded or unwound, but not the first section 10 nor the third section 30. The view to the drawing plane of
[0286] An elevated or prominent structure 25 may be recognized, which extends away from the inner side of the second section 20, and which, during use of the prosthesis covering 100, extends radially into its interior.
[0287] The structure 25 may preferably extend in a longitudinal direction of the prosthesis covering 100. It serves to prevent the second section 20 from lying completely planar on the patient's body. Benefited by the distance, the structure 25 keeps open between the inner side of the second section 20 and the patient's body (e.g. the skin), a negative pressure between the inner side of the second section 20 and the patient's body may be established by suitable negative pressure devices without any relevant niche formations.
[0288]
LIST OF REFERENCE NUMERALS
[0289] 100 prosthesis covering [0290] 101 outer skin [0291] 10 first section [0292] 11 area [0293] 13 inner liner [0294] 20 second section [0295] 21 first subsection [0296] 22 second subsection [0297] 23 doublings, doubled area [0298] 25 elevated structure [0299] 30 third section [0300] 31 protrusion [0301] 32 fastening section [0302] 33 inner liner [0303] 35 sticking area [0304] 40 cutting line [0305] 50 drawing ruler [0306] D10 diameter of the first section [0307] D20 diameter of the second section [0308] D30 diameter of the third section [0309] B-B cutting line [0310] I interior of the prosthesis covering [0311] L longitudinal direction