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WO2019164465A2 - Revêtement hybride perfectionné - Google Patents

Revêtement hybride perfectionné Download PDF

Info

Publication number
WO2019164465A2
WO2019164465A2 PCT/TR2018/050271 TR2018050271W WO2019164465A2 WO 2019164465 A2 WO2019164465 A2 WO 2019164465A2 TR 2018050271 W TR2018050271 W TR 2018050271W WO 2019164465 A2 WO2019164465 A2 WO 2019164465A2
Authority
WO
WIPO (PCT)
Prior art keywords
liner
layer
strips
intermediate layer
stump
Prior art date
Legal status (The legal status is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the status listed.)
Ceased
Application number
PCT/TR2018/050271
Other languages
English (en)
Other versions
WO2019164465A3 (fr
Inventor
Mustafa DUGER
Current Assignee (The listed assignees may be inaccurate. Google has not performed a legal analysis and makes no representation or warranty as to the accuracy of the list.)
Md Group Rehabilitasyon Saglik Sanayi Tic AS
Original Assignee
Md Group Rehabilitasyon Saglik Sanayi Tic AS
Priority date (The priority date is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the date listed.)
Filing date
Publication date
Priority claimed from TR2018/02549A external-priority patent/TR201802549A2/tr
Application filed by Md Group Rehabilitasyon Saglik Sanayi Tic AS filed Critical Md Group Rehabilitasyon Saglik Sanayi Tic AS
Publication of WO2019164465A2 publication Critical patent/WO2019164465A2/fr
Publication of WO2019164465A3 publication Critical patent/WO2019164465A3/fr
Anticipated expiration legal-status Critical
Ceased legal-status Critical Current

Links

Classifications

    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61F—FILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
    • A61F2/00—Filters implantable into blood vessels; Prostheses, i.e. artificial substitutes or replacements for parts of the body; Appliances for connecting them with the body; Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents
    • A61F2/50—Prostheses not implantable in the body
    • A61F2/78—Means for protecting prostheses or for attaching them to the body, e.g. bandages, harnesses, straps, or stockings for the limb stump
    • A61F2/7812—Interface cushioning members placed between the limb stump and the socket, e.g. bandages or stockings for the limb stump
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61F—FILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
    • A61F2/00—Filters implantable into blood vessels; Prostheses, i.e. artificial substitutes or replacements for parts of the body; Appliances for connecting them with the body; Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents
    • A61F2/50—Prostheses not implantable in the body
    • A61F2/78—Means for protecting prostheses or for attaching them to the body, e.g. bandages, harnesses, straps, or stockings for the limb stump
    • A61F2/80—Sockets, e.g. of suction type
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61F—FILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
    • A61F2/00—Filters implantable into blood vessels; Prostheses, i.e. artificial substitutes or replacements for parts of the body; Appliances for connecting them with the body; Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents
    • A61F2/50—Prostheses not implantable in the body
    • A61F2/78—Means for protecting prostheses or for attaching them to the body, e.g. bandages, harnesses, straps, or stockings for the limb stump
    • A61F2/80—Sockets, e.g. of suction type
    • A61F2002/802—Suction sockets, i.e. utilizing differential air pressure to retain the prosthesis on the stump

Definitions

  • the present invention relates to a hybrid liner for prosthetics, in which the flexibility capability can be controlled.
  • the liner systems are absorbing the impacts and fully grasping the stump by providing suspension, in order to make sure that the stump inside the socket is able to move freely.
  • silicon and gel materials shall be preferred, that attach to the stump surface well and that provide comfort to the stump.
  • the aim of the present invention is to develop a liner that adapts to the shape of the stump, and at the same time which is comfortable and durable.
  • Another object of this invention is to develop a liner that is flexible towards the sides, therefore can be worn comfortably to the stump.
  • Yet another object of the present invention is to develop a liner that is flexible towards the sides, so that can adapt to the shape of the stump, in case muscular mass, lipid mass of the user changes or edema occurs.
  • a further object of the present invention to develop a liner, which is resistant to tensile forces applied by the user, while the liner is worn to the stump.
  • a liner has been developed that includes an intermediate layer between at least two layers, and exhibiting a specific distribution of elasticity modulus across the area between those layers. The production method of this liner is also explained.
  • Figure-1 Is the side schematic view of the liner according to an embodiment of the invention.
  • Figure-2 Is the side schematic sectional view of the liner of the Figure 1.
  • Figure-3 Is the side schematic sectional view of the structure obtained from the step 101.
  • Figure-4 Is the side schematic sectional view of the structure obtained from the step 102.
  • Figure-5 Is the side schematic sectional view of the structure obtained from the step 103.
  • Figure-6 Is the side schematic sectional view of the structure obtained from the step 104.
  • Figure-7 Is the side schematic sectional view of the structure obtained from the step 201.
  • Figure-8 Is the side schematic sectional view of the structure obtained from the step 202.
  • Figure-9 Is the side schematic sectional view of the structure obtained from the step 203.
  • Figure-10 Is the flow chart of the production method of the liner according to the embodiment, wherein the first material of the invention is gel.
  • Figure-11 Is the flow chart of the production method of the liner according to the embodiment, wherein the first material of the invention is silicone.
  • Figure-12 Is the side schematic view of the liner according to the invention which is coated with a coating fabric.
  • Figure-13 Is the side schematic sectional view of the liner of the Figure 12.
  • Figure-14 Is the side schematic view of the liner according to an embodiment of the invention.
  • Figure-15 Is the side schematic sectional view of the liner of the Figure 14.
  • Figure-16 Is the side schematic sectional view of the structure obtained from the step 301.
  • Figure-17 Is the side schematic sectional view of the structure obtained from the step 302.
  • Figure-18 Is the view of the structure obtained from the step 302, from the edge facing the socket.
  • Figure-19 Is the view of an alternative structure obtained from the step 302, from the edge facing the socket.
  • Figure-20 Is the side schematic sectional view of the structure obtained from the step 303.
  • Figure-21 Is the flow chart of the liner production method according to the invention.
  • FIG-22 Is the detailed view of the region marked in Figure 2 and Figure 15.
  • Figure-23 Is the detailed view of another flexible wall which can be used with the liner of the invention.
  • Figure-24 Is the detailed view of another flexible wall which can be used with the liner of the invention.
  • Figure-25 Is the detailed view of another flexible wall which can be used with the liner of the invention.
  • Figure-26 Is the detailed view of another flexible wall which can be used with the liner of the invention.
  • Figure-27 Is the side schematic view of the liner according to the invention which is coated with a coating fabric.
  • Figure-28 Is the side schematic sectional view of the liner of the Figure 27.
  • Figure-29 Is the side schematic sectional view of the liner comprising an auxiliary strip according to the invention.
  • Figure-B0 Is the view from the edge facing the socket of the structure obtained after the steps 302 and 305 during the liner production shown in the Figure 29.
  • Figure-31 Is the side schematic sectional view of the liner comprising an auxiliary strip according to the invention.
  • Figure-32 Is the view from the edge facing the socket of the structure obtained after the steps 302 and 305 during the liner production shown in Figure 31.
  • Figure-33 Is the flow chart of the liner production method according to the invention, also comprising the step of adding at least one auxiliary strip.
  • a liner (1) according to the invention essentially comprises at least two layers, one fitting on the stump and, the other fitting to the inner surface of the socket and at least one intermediate layer between at least two of the successive layers.
  • the intermediate layer allows the liner (1) to stretch, in order to adjust to the shape of the stump, in case of the muscles mass, lipid mass of the user changes, or edema occurs, and to stretch for providing comfort during wearing; ensures resistance against the tensile forces and stretches exposed during wearing the liner (1) to the stump.
  • the intermediate layer lies continuously or intermittently along a contiguous area formed by abutting of two consecutive layers to each other.
  • the intermediate layer has a specific distribution of elasticity moduli along the intermediate layer abutment area.
  • the intermediate layer is preferably fabric.
  • the flexibility of the intermediate layer may be directional, i.e., may be flexible in different directions at different levels.
  • the intermediate layer can also be obtained by combining one or more elements.
  • the inventive liner (1) preferably comprises two layers, the first layer (2) resting on the stump and the second layer (3) seated on the inner face of the socket, and an intermediate layer between the first layer (2) and the second layer (3).
  • a liner (1) production method comprises the following steps: placing the intermediate layer on a first male mold, - pouring a first material between the first male mold and a first female mold, inverting the resulting structure and fitting it onto a second male mold, pouring a second material between the second male mold and a second female mold.
  • a liner (1) production method in essence, comprises the following steps: pouring a first material between a male mold and a first female mold, placing the intermediate layer on the structure obtained, placing the resultant structure on a second female mold, and casting a second material between this structure and the second female mold.
  • a liner (1) production method comprises the following steps: placing the intermediate layer on a first male mold, pouring a first material between the first male mold and a first female mold, pouring a second material between a second male mold and a second female mold. adhering the resulting structures to each other in such a way that the intermediate layer remains in between.
  • the intermediate layer consists of a sheet (4) continuously lying between the first layer (2) and the second layer (3).
  • the first layer (2) and the second layer (3) may be made of respectively a first material and a second material, that have different characteristics and that do not bind to each other.
  • the first material and the second material may be selected from elastic materials such as silicone and gel.
  • the hardness of the first material is equal to or less than the hardness of the second material.
  • the sheet (4a) also helps the first material and the second material which can not bind each other due to different characteristics to unite, by enabling them to bind to its different faces separately.
  • the second layer (3) also comprises at least one flexible wall (5) providing seal for protecting the vacuum within the socket.
  • the flexible walls (5) are in the form of a ring surrounding the liner (1).
  • the sheet (4a) is preferably made of fabric.
  • sheet (4) may be made of a cellulosic based material, a polymer, or one or more other materials.
  • the liner (1) must be easily inserted into the socket, and at the same time, be easily removed from the socket.
  • a liner (1) production method in which the first material is a gel, in essence, comprises the following steps:
  • the second material may be a gel, as well as it might be a silicone.
  • a liner (1) production method in which the first material is a silicone, in essence, comprises the following steps: (201) pouring the first material between a male mold in form of a stump and a first female mold, which is a silicone,
  • the second material may be a gel, as well as it might be a silicone.
  • the hardness of the first material, which is on the face of the liner (1), which fits to the stump, is equal to or less than the hardness of the second material.
  • the liner (1) can completely adapt to the stump, and provide comfort.
  • the second material provides strength to the liner (1).
  • steps 102, 104, 201 and 203 are maintained until the material being cast comes to a state where it can retain its form. For example, a hot casted material is left for cooling.
  • the sheet (4a) is preferably a fabric having a specific elastic modulus along the abutment area. This particular modulus of elasticity may vary regularly along the contact area, or may be determined locally. The elasticity modulus can also be constant along the abutment area. In addition, the elasticity modulus of the sheet (4a) may vary depending on the direction, along the abutment area.
  • the sheet (4a) can be a mesh fabric, so that the desired distribution of elasticity moduli can be obtained.
  • the sheet (4a) can also consist of more than one pieces joined together.
  • the intermediate layer consists of more than one strips (4b) placed between the first layer (2) and the second layer (3), and overlapping on the bottom point, whereas not contacting to each other on the outlet.
  • the outlet refers to the opening of the liner (1) through which the stump is inserted, while the bottom refers to the point on the liner (1) corresponding to the tip of the stump. Due to the overlapping of the strips (4b) onto each other on the bottom point, the liner (1) can withstand the stretching forces applied by the user during the wearing the liner (1) to the stump, as a whole. The liner (1) is able to stretch to sides, thanks to the strips (4b) not contacting each other on the outlet.
  • the liner (1) can be easily fitted to the stump, and can be adapted to the shape of the stump, in cases such as the muscle mass of the user changes, the lipid mass changes, or edema occurs.
  • the ability of the liner (1) to stretch to the sides, also provides comfort during the fitting of the liner (1) to the stump.
  • each strip (4b) has a length such that both ends of it reach the outlet of the liner (1) at opposing points. In this way, a liner (1) comprising two or three strips (4b) both has sufficient strength and has sufficient flexibility.
  • strips (4b) may have equal angular spacing between each other on the bottom point, they may have differing angular spacing, to provide a denser placement on the parts where greater load is present on the liner (1).
  • Strips (4b) are preferably made of fabric. However, strips (4b) may be made of a cellulosic based material, a polymer, or one or more other materials.
  • the first layer (2) and the second layer (S) are selected from elastic materials such as silicone and gel.
  • the first layer (2) and the second layer (S) may be made of the same or different materials.
  • the second layer (3) also comprises at least one flexible wall (5) providing seal for protecting the vacuum within the socket.
  • the flexible walls (5) are in the form of a ring surrounding the liner (1).
  • One or more of the strips (4b) may comprise yarns, extending lengthwise, in order to increase the strength during pulling.
  • One or more of the strips (4b) may comprise yawns extending diagonally , whose width contract under the influence of pulling and provide a tighter fit of the liner (1) over the stump following release.
  • One or more of the strips (4b) may also comprise lengthwise, and diagonally extending yarns together.
  • the liner (1) must be easily inserted into the socket, and at the same time, be easily removed from the socket.
  • the inventive liner (1) may also comprise at least one auxiliary strip (8) extending along a direction encircling the stump.
  • the auxiliary strip (8) is preferably in the form of a closed ring. This closed ring may be obtained by joining the ends of one or more pieces, or may be obtained from a single piece of a ring.
  • the auxiliary strip (8) is between the strips (4b) and the first layer (2) or between the strips (4b) and the second layer (3) or, in an alternating or a different order, at some points, between the strips (4b) and the first layer (2), and at some points between the strips (4b) and the second layer (3). Substances, such as an adhesive, between the auxiliary strip (8) and the strip (4b), interconnecting those, may be present.
  • Auxiliary strip (8) increases the strength of the liner (1), by helping to distribute the forces acting on the strips (4b).
  • Auxiliary strip (4b) is preferably made of fabric.
  • auxiliary strip (4b) may be made of a cellulosic based material, a polymer, or one or more other materials.
  • a liner (1) production method comprises the following steps: (301) formation of the first layer (2) by pouring an elastic material, such as silicone and gel, between a male mold in form of a stump and a first female mold,
  • an adhesive may also be applied on the first layer (2) before the strips (4b) are placed.
  • step 303 there are grooves on the second female mold.
  • the material that fills these grooves in step 303 provides for the formation of flexible walls (5) that ensure sealing on the liner (1).
  • steps 301 and 303 are maintained until the material being cast comes to a state where it can retain its form. For example, a hot casted material is left for cooling.
  • step numbered 304 it is also possible to apply coating (6) or coating fabric (7) by fitting a coating fabric (7) on the outer surface mentioned or by coating a material in liquid or solution form on the outer surface mentioned by means of spraying, dipping, etc.
  • a step (305) of placing at least one auxiliary strip (8) extending in a direction to encircle the stump on the first layer (2) is also applied.
  • the intermediate layer may comprise both the sheet (4a) and the strips (4b).

Landscapes

  • Health & Medical Sciences (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Public Health (AREA)
  • Transplantation (AREA)
  • Engineering & Computer Science (AREA)
  • Biomedical Technology (AREA)
  • Heart & Thoracic Surgery (AREA)
  • Oral & Maxillofacial Surgery (AREA)
  • Animal Behavior & Ethology (AREA)
  • Vascular Medicine (AREA)
  • General Health & Medical Sciences (AREA)
  • Cardiology (AREA)
  • Veterinary Medicine (AREA)
  • Prostheses (AREA)
  • Materials For Medical Uses (AREA)
  • Orthopedics, Nursing, And Contraception (AREA)

Abstract

La présente invention concerne un revêtement hybride pour prothèses, dont la capacité de flexibilité peut être réglée. Un revêtement développé selon l'invention comprend une couche intermédiaire entre au moins deux couches, et présente une répartition spécifique de module d'élasticité dans toute la zone entre ces couches. L'invention concerne également le procédé de production de ce revêtement.
PCT/TR2018/050271 2018-02-22 2018-05-28 Revêtement hybride perfectionné Ceased WO2019164465A2 (fr)

Applications Claiming Priority (4)

Application Number Priority Date Filing Date Title
TR2018/02549 2018-02-22
TR2018/02549A TR201802549A2 (tr) 2018-02-22 2018-02-22 Çi̇ft etki̇li̇ li̇ner
TR201805042 2018-04-09
TR2018/05042 2018-04-09

Publications (2)

Publication Number Publication Date
WO2019164465A2 true WO2019164465A2 (fr) 2019-08-29
WO2019164465A3 WO2019164465A3 (fr) 2019-12-12

Family

ID=67687314

Family Applications (1)

Application Number Title Priority Date Filing Date
PCT/TR2018/050271 Ceased WO2019164465A2 (fr) 2018-02-22 2018-05-28 Revêtement hybride perfectionné

Country Status (1)

Country Link
WO (1) WO2019164465A2 (fr)

Family Cites Families (3)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US9248032B2 (en) * 2010-10-14 2016-02-02 Ossur Hf Suspension liner system with distensible seal
US20160338858A1 (en) * 2015-05-19 2016-11-24 Lim Innovations, Inc. Prosthetic socket liner garment
EP3362003B1 (fr) * 2015-10-15 2021-01-06 Össur Iceland EHF Système d'étanchéité réglable

Also Published As

Publication number Publication date
WO2019164465A3 (fr) 2019-12-12

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