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EP4514281A1 - Nouveau revêtement en silicone - Google Patents

Nouveau revêtement en silicone

Info

Publication number
EP4514281A1
EP4514281A1 EP23804195.8A EP23804195A EP4514281A1 EP 4514281 A1 EP4514281 A1 EP 4514281A1 EP 23804195 A EP23804195 A EP 23804195A EP 4514281 A1 EP4514281 A1 EP 4514281A1
Authority
EP
European Patent Office
Prior art keywords
silicone
liner
making
sidewalls
microcraters
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.)
Pending
Application number
EP23804195.8A
Other languages
German (de)
English (en)
Inventor
Aldo Laghi
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.)
ALPS South LLC
Original Assignee
ALPS South LLC
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 US17/742,721 external-priority patent/US20220266481A1/en
Application filed by ALPS South LLC filed Critical ALPS South LLC
Publication of EP4514281A1 publication Critical patent/EP4514281A1/fr
Pending 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
    • B—PERFORMING OPERATIONS; TRANSPORTING
    • B29—WORKING OF PLASTICS; WORKING OF SUBSTANCES IN A PLASTIC STATE IN GENERAL
    • B29C—SHAPING OR JOINING OF PLASTICS; SHAPING OF MATERIAL IN A PLASTIC STATE, NOT OTHERWISE PROVIDED FOR; AFTER-TREATMENT OF THE SHAPED PRODUCTS, e.g. REPAIRING
    • B29C33/00—Moulds or cores; Details thereof or accessories therefor
    • B29C33/38—Moulds or cores; Details thereof or accessories therefor characterised by the material or the manufacturing process
    • B—PERFORMING OPERATIONS; TRANSPORTING
    • B29—WORKING OF PLASTICS; WORKING OF SUBSTANCES IN A PLASTIC STATE IN GENERAL
    • B29C—SHAPING OR JOINING OF PLASTICS; SHAPING OF MATERIAL IN A PLASTIC STATE, NOT OTHERWISE PROVIDED FOR; AFTER-TREATMENT OF THE SHAPED PRODUCTS, e.g. REPAIRING
    • B29C33/00—Moulds or cores; Details thereof or accessories therefor
    • B29C33/42—Moulds or cores; Details thereof or accessories therefor characterised by the shape of the moulding surface, e.g. ribs or grooves

Definitions

  • This invention relates to liners for use in a prosthetic assembly. Specifically, the described invention relates to liners having a silicone lining that is smooth to the touch via the use of sand-blasting the molds used to create the liners.
  • Silicone liners have been used since the 1980s in the prosthetic industry such as those described in U.S. Patent No. 4,923,474 granted to Klassen and Kristinsson.
  • Other examples of such liners include U.S. Pat. No. 5,728,168 to Laghi et al., U.S. Pat. 5,830,237 granted to Kania, U.S Patent No. 5,507,834 to Laghi et al., U.S. Patent No. 5,443,525 to Laghi et al., and U.S. Patent 5,728,168 to Laghi et al.
  • silicone liners have historically been difficult to take on an off due to the high coefficient of static friction of silicone. As such, they tend to stick to the skin of a residual limb. This prevents relative movement at the interface skin/liner and therefore induces high shear forces on the skin in localized portions of the residual limb as the ground reaction to ambulation is transmitted to the skeleton through the silicone interface and the skin. These resulting shear forces increase the likelihood of blistering of the skin, especially for patients with sensitive skin. It is therefore desired to develop a silicone liner having a reduced frictional effect such that the user can easily don and doff their prosthetic liner.
  • the present invention utilizes a novel sandblasting technique so as to create “microcraters” in the silicone of the prosthetic liner, as it is molded, which allow for the liner to be donned and doffed with ease and which is skin-friendly.
  • the method described herein is particularly effective for silicone liners because silicones, when in the liquid state, have low surface tension which allows them to penetrate tiny holes and cracks and, therefore, to create the microcraters. Silicones’ viscosity is also inversely proportional to temperature which makes silicone flow easier as they get closer to the surface of the hold mold. As a result, silicones produce a faithful mirror image of the cratered mold surface.
  • Another object of the invention is to provide a silicone liner with a more comfortable interior silicone lining.
  • Another object of the invention is to provide a method of manufacturing silicone liners having reduced frictional characteristics.
  • Another object of the invention is to provide a liner having microcraters.
  • Another object of the invention is to describe a method of making silicone liners by molding the liners using mold mandrels that have been sandblasted.
  • the present invention relates generally to a liner for use in a prosthetic assembly having a silicone interior comprising microcraters by sandblasting the silicone mandrel using #36 grit at 100 psi. Using a sandblasted mold mandrel, a silicone liner can be manufactured having improved friction characteristics.
  • the liner of the present invention may optionally include a fabric cover bonded to the exterior surface.
  • F ig. l is a front view of the improved silicone liner
  • Fig. 2 is a sectional view 7 of a silicone sheet formed using a mandrel that has not been sandblasted.
  • Fig. 3 is a sectional view 7 of a silicone sheet formed using a mandrel sandblasted with #36 grit at 100 psi.
  • Fig. 4 is a sectional view of a silicone sheet formed using a mandrel sandblasted with #320 grit at 100 psi.
  • Fig. 5 is a graph showing the effect of sandblasting on the pulling force necessary to remove a silicone sheet from a steel substrate showing the effect on the static coefficient of friction.
  • the present invention relates to a liner 100 for use with prosthetic devices.
  • the liner 100 for use with a prosthetic assembly comprises an open upper end 12 for receiving a residual limb, not shown, a closed botom end 14, and sidewalls 16 of predetermined thickness.
  • the liner is airtight when donned over a residual limb.
  • the preferred thickness of the sidewalls 16 is about 1.5mm to 3.0 mm. Note that the thickness is greater at the bottom end than in the sidewalls; the preferred thickness of the silicone at said bottom end 14 is about 3.0 mm to 12.0 mm.
  • the sidewalls 16 have an inner layer 18 of the improved silicone described herein.
  • the sidewalls 16 can be fabric or another layer of more durable and higher friction silicone.
  • a mandrel Prior to molding the silicone, a mandrel is sandblasted using #36 grit at 100 psi.
  • the particular grit and pressure used provide the beneficial characteristics of the present invention. Other grits and pressures did not produce the benefits of reduced frictional hold and less chance of skin irritation. .
  • the silicone is molded over it, allowing the silicone to seep into the microcraters formed by the sandblasting. As can be seen in Figs. 2-4, the size of grit used during sandblasting has a sizeable effect.
  • Fig. 2 depicts a sheet of silicone 20 that has not been sandblasted. As can be seen by the cross-section 2-2, not sandblasting the mandrel results in a smooth exterior surface 22 which maintains the high frictional characteristics of silicone.
  • Figs. 3 and 4 show' a microscopic view of exterior surface 22 after the mandrel sandblasted.
  • Fig. 3 shows the microcrating the exterior surface 22 is subjected to using #36 grit at 100 psi thereby creating microcraters 24. Along line 3-3, the microcraters created generally have a depth of about 0.0195 mm.
  • FIG. 4 shows the microcrating the exterior surface 22 is subjected to using #320 grit at 100 psi.
  • Sandblasting with #320 grit may be done alone or after the mandrel has been sandblasted with #36 grit.
  • the microcraters created generally have a depth of about 0.0100 mm. The deeper microcraters create a lower static coefficient of friction for silicone because there is less surface area for the exterior surface 22 to be in contact with, as can be seen when comparing the sheet in Fig, 3 with the sheet in Fig. 4.
  • Sandblasting between #36 and #320 grit may also be performed.
  • microcraters 24 of differing depths include, but are not limited to, modification of the mandrel surface via rolling, compression of the mold against a textured surface, chemical etching, laser engraving, computer numerical control (CNC) engraving, electro-erosion (i.e. electric discharge machining), electrodeposition, laser micro melting, shot blasting, shot peening, and pinwheeling. Similar methods now know 7 or to be discovered which are equivalent to the methods included (i.e. methods that create microcraters in the exterior surface of a silicone layer in a prosthetic liner) are intended to be included in the above listing

Landscapes

  • Health & Medical Sciences (AREA)
  • Cardiology (AREA)
  • Oral & Maxillofacial Surgery (AREA)
  • Transplantation (AREA)
  • Engineering & Computer Science (AREA)
  • Biomedical Technology (AREA)
  • Heart & Thoracic Surgery (AREA)
  • Vascular Medicine (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Animal Behavior & Ethology (AREA)
  • General Health & Medical Sciences (AREA)
  • Public Health (AREA)
  • Veterinary Medicine (AREA)
  • Prostheses (AREA)
  • Casting Or Compression Moulding Of Plastics Or The Like (AREA)

Abstract

L'invention concerne un revêtement prothétique en silicone destiné à être utilisé avec un ensemble prothétique qui agit en tant qu'interface entre le membre résiduel d'un amputé et l'ensemble emboîture. Le revêtement prothétique comprend une extrémité proximale ouverte, une extrémité distale fermée et des parois latérales comprenant une couche interne de silicone moulée. La silicone est moulée sur un mandrin qui a été sablé à l'aide d'un grain n° 36 et, éventuellement, d'un grain n° 320 à 100 psi de façon à former des micro-cratères et à réduire le coefficient de frottement statique.
EP23804195.8A 2022-05-12 2023-05-10 Nouveau revêtement en silicone Pending EP4514281A1 (fr)

Applications Claiming Priority (2)

Application Number Priority Date Filing Date Title
US17/742,721 US20220266481A1 (en) 2019-05-07 2022-05-12 Novel Silicone Liner
PCT/US2023/021696 WO2023220151A1 (fr) 2022-05-12 2023-05-10 Nouveau revêtement en silicone

Publications (1)

Publication Number Publication Date
EP4514281A1 true EP4514281A1 (fr) 2025-03-05

Family

ID=88730890

Family Applications (1)

Application Number Title Priority Date Filing Date
EP23804195.8A Pending EP4514281A1 (fr) 2022-05-12 2023-05-10 Nouveau revêtement en silicone

Country Status (3)

Country Link
EP (1) EP4514281A1 (fr)
CN (1) CN119546259A (fr)
WO (1) WO2023220151A1 (fr)

Family Cites Families (5)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US5772864A (en) * 1996-02-23 1998-06-30 Meadox Medicals, Inc. Method for manufacturing implantable medical devices
DE102014011034B4 (de) * 2014-07-23 2016-06-23 Uniprox GmbH & Co. KG Perforierter Liner
US11045307B2 (en) * 2016-05-11 2021-06-29 Establishment Labs S.A. Medical implants and methods of preparation thereof
WO2020227478A1 (fr) * 2019-05-07 2020-11-12 Alps South Europe, S.R.O. Doublure de prothèse en silicone sablée
US20220266481A1 (en) * 2019-05-07 2022-08-25 Aldo Laghi Novel Silicone Liner

Also Published As

Publication number Publication date
WO2023220151A1 (fr) 2023-11-16
CN119546259A (zh) 2025-02-28

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