WO2020251454A1 - A medical support device - Google Patents

A medical support device Download PDF

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Publication number
WO2020251454A1
WO2020251454A1 PCT/SE2020/050579 SE2020050579W WO2020251454A1 WO 2020251454 A1 WO2020251454 A1 WO 2020251454A1 SE 2020050579 W SE2020050579 W SE 2020050579W WO 2020251454 A1 WO2020251454 A1 WO 2020251454A1
Authority
WO
WIPO (PCT)
Prior art keywords
support device
medical support
medical
matrix
elastomer
Prior art date
Application number
PCT/SE2020/050579
Other languages
French (fr)
Inventor
Per HEDÉN
Original Assignee
Per Hedén Aesthetic Surgery Ab
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
Application filed by Per Hedén Aesthetic Surgery Ab filed Critical Per Hedén Aesthetic Surgery Ab
Priority to EP20823250.4A priority Critical patent/EP3982878A4/en
Priority to US17/618,113 priority patent/US20220346940A1/en
Priority to CN202080043451.7A priority patent/CN113966208A/en
Priority to AU2020290877A priority patent/AU2020290877A1/en
Priority to IL288902A priority patent/IL288902B2/en
Priority to CA3140990A priority patent/CA3140990A1/en
Priority to KR1020217041957A priority patent/KR20220024150A/en
Priority to BR112021025134A priority patent/BR112021025134A2/en
Priority to JP2021574187A priority patent/JP7520057B2/en
Publication of WO2020251454A1 publication Critical patent/WO2020251454A1/en

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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
    • A61F2/0063—Implantable repair or support meshes, e.g. hernia meshes
    • 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
    • A61F2/02—Prostheses implantable into the body
    • A61F2/12—Mammary prostheses and implants
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61L—METHODS OR APPARATUS FOR STERILISING MATERIALS OR OBJECTS IN GENERAL; DISINFECTION, STERILISATION OR DEODORISATION OF AIR; CHEMICAL ASPECTS OF BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES; MATERIALS FOR BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES
    • A61L27/00—Materials for grafts or prostheses or for coating grafts or prostheses
    • A61L27/14—Macromolecular materials
    • A61L27/18—Macromolecular materials obtained otherwise than by reactions only involving carbon-to-carbon unsaturated bonds
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61L—METHODS OR APPARATUS FOR STERILISING MATERIALS OR OBJECTS IN GENERAL; DISINFECTION, STERILISATION OR DEODORISATION OF AIR; CHEMICAL ASPECTS OF BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES; MATERIALS FOR BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES
    • A61L27/00—Materials for grafts or prostheses or for coating grafts or prostheses
    • A61L27/14—Macromolecular materials
    • A61L27/20—Polysaccharides
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61L—METHODS OR APPARATUS FOR STERILISING MATERIALS OR OBJECTS IN GENERAL; DISINFECTION, STERILISATION OR DEODORISATION OF AIR; CHEMICAL ASPECTS OF BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES; MATERIALS FOR BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES
    • A61L27/00—Materials for grafts or prostheses or for coating grafts or prostheses
    • A61L27/36—Materials for grafts or prostheses or for coating grafts or prostheses containing ingredients of undetermined constitution or reaction products thereof, e.g. transplant tissue, natural bone, extracellular matrix
    • A61L27/3604—Materials for grafts or prostheses or for coating grafts or prostheses containing ingredients of undetermined constitution or reaction products thereof, e.g. transplant tissue, natural bone, extracellular matrix characterised by the human or animal origin of the biological material, e.g. hair, fascia, fish scales, silk, shellac, pericardium, pleura, renal tissue, amniotic membrane, parenchymal tissue, fetal tissue, muscle tissue, fat tissue, enamel
    • 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
    • A61F2/0077—Special surfaces of prostheses, e.g. for improving ingrowth
    • 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
    • A61F2/0077—Special surfaces of prostheses, e.g. for improving ingrowth
    • A61F2002/0081—Special surfaces of prostheses, e.g. for improving ingrowth directly machined on the prosthetic surface, e.g. holes, grooves
    • 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
    • A61F2220/00—Fixations or connections for prostheses classified in groups A61F2/00 - A61F2/26 or A61F2/82 or A61F9/00 or A61F11/00 or subgroups thereof
    • A61F2220/0008—Fixation appliances for connecting prostheses to the body
    • 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
    • A61F2240/00—Manufacturing or designing of prostheses classified in groups A61F2/00 - A61F2/26 or A61F2/82 or A61F9/00 or A61F11/00 or subgroups thereof
    • A61F2240/001—Designing or manufacturing processes
    • A61F2240/002—Designing or making customized prostheses
    • A61F2240/004—Using a positive or negative model, e.g. moulds
    • 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
    • A61F2250/00—Special features of prostheses classified in groups A61F2/00 - A61F2/26 or A61F2/82 or A61F9/00 or A61F11/00 or subgroups thereof
    • A61F2250/0014—Special features of prostheses classified in groups A61F2/00 - A61F2/26 or A61F2/82 or A61F9/00 or A61F11/00 or subgroups thereof having different values of a given property or geometrical feature, e.g. mechanical property or material property, at different locations within the same prosthesis
    • A61F2250/0025—Special features of prostheses classified in groups A61F2/00 - A61F2/26 or A61F2/82 or A61F9/00 or A61F11/00 or subgroups thereof having different values of a given property or geometrical feature, e.g. mechanical property or material property, at different locations within the same prosthesis differing in roughness
    • 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
    • A61F2250/00—Special features of prostheses classified in groups A61F2/00 - A61F2/26 or A61F2/82 or A61F9/00 or A61F11/00 or subgroups thereof
    • A61F2250/0014—Special features of prostheses classified in groups A61F2/00 - A61F2/26 or A61F2/82 or A61F9/00 or A61F11/00 or subgroups thereof having different values of a given property or geometrical feature, e.g. mechanical property or material property, at different locations within the same prosthesis
    • A61F2250/0026—Special features of prostheses classified in groups A61F2/00 - A61F2/26 or A61F2/82 or A61F9/00 or A61F11/00 or subgroups thereof having different values of a given property or geometrical feature, e.g. mechanical property or material property, at different locations within the same prosthesis differing in surface structures
    • 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
    • A61F2250/00—Special features of prostheses classified in groups A61F2/00 - A61F2/26 or A61F2/82 or A61F9/00 or A61F11/00 or subgroups thereof
    • A61F2250/0014—Special features of prostheses classified in groups A61F2/00 - A61F2/26 or A61F2/82 or A61F9/00 or A61F11/00 or subgroups thereof having different values of a given property or geometrical feature, e.g. mechanical property or material property, at different locations within the same prosthesis
    • A61F2250/003—Special features of prostheses classified in groups A61F2/00 - A61F2/26 or A61F2/82 or A61F9/00 or A61F11/00 or subgroups thereof having different values of a given property or geometrical feature, e.g. mechanical property or material property, at different locations within the same prosthesis differing in adsorbability or resorbability, i.e. in adsorption or resorption time
    • A61F2250/0031—Special features of prostheses classified in groups A61F2/00 - A61F2/26 or A61F2/82 or A61F9/00 or A61F11/00 or subgroups thereof having different values of a given property or geometrical feature, e.g. mechanical property or material property, at different locations within the same prosthesis differing in adsorbability or resorbability, i.e. in adsorption or resorption time made from both resorbable and non-resorbable prosthetic parts, e.g. adjacent parts
    • 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
    • A61F2250/00—Special features of prostheses classified in groups A61F2/00 - A61F2/26 or A61F2/82 or A61F9/00 or A61F11/00 or subgroups thereof
    • A61F2250/0058—Additional features; Implant or prostheses properties not otherwise provided for
    • A61F2250/0067—Means for introducing or releasing pharmaceutical products into the body
    • 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
    • A61F2250/00—Special features of prostheses classified in groups A61F2/00 - A61F2/26 or A61F2/82 or A61F9/00 or A61F11/00 or subgroups thereof
    • A61F2250/0058—Additional features; Implant or prostheses properties not otherwise provided for
    • A61F2250/0069—Sealing means
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61L—METHODS OR APPARATUS FOR STERILISING MATERIALS OR OBJECTS IN GENERAL; DISINFECTION, STERILISATION OR DEODORISATION OF AIR; CHEMICAL ASPECTS OF BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES; MATERIALS FOR BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES
    • A61L2430/00—Materials or treatment for tissue regeneration
    • A61L2430/04—Materials or treatment for tissue regeneration for mammary reconstruction

Definitions

  • the present invention concerns a medical support device for use in a human body part, a method of producing it and to use it.
  • a filling such as silicone gel or saline
  • the matrix may be absorbable or not by the human body.
  • the aim of the present invention is to be able to support and/or augment a human body part without the previously known drawbacks.
  • a medical support device for use in a human body part.
  • the device comprises at least a wall shaped portion having a first side, which shows a bulge out of a plane, and a second side of the wall shaped portion has a corresponding cavity, for example as a dome shape, wherein the medical support device comprises an elastomer.
  • the wall shaped portion is curved around more than one axis or has a draped shape.
  • the medical support device is open from the plane into the cavity, i.e. never closed such as, for example, a common breast implant filled with liquid silicone gel or saline.
  • the medical support device With the medical support device according to the invention it will be possible to keep en dogenous tissue and/or fat and/or added material, such as hyaluronic acid in place in the human body part.
  • An advantage with this solution is that it will be permeable for x-ray ra diation when filled with endogenous tissue and/or fat, which is important for secure mam- mography.
  • the wall thickness i.e. between the first side and second side, is more or less the same over the wall shaped portion.
  • the medical support is pre-shaped.
  • a rim in the plane is at least partially present along an edge of the cavity.
  • the rim will make it easier to apply sutures to the medical support device when fastening it to the tissue of the body part. Attaching the medical support device will in turn lead to less problems with malpositioning, such as rotation, and lateral and bottoming out movement of the implant. It will also make sure the material in the cavity of the medical support device stays in place.
  • the device is made of an elastomer and provided with a matrix at least at the rim. According to an embodiment the device is made of an elastomer and provided with a matrix at least partially at the second side, cavity side, of the wall shaped portion.
  • a device is used in a breast, preferably in a woman's breast.
  • a method of producing a medical support device provided, whereby a mandrel having a desired shape is dipped in an unhardened elastomer to shape the device.
  • Preferably at least a piece of matrix is arranged on the man drel before or on the device after the dipping.
  • a method of using such a medical support device according is provided.
  • An implant without incapsulated material is formed, where the med ical support device keeps endogenous tissue and/or fat and/or added material, such as hy aluronic acid, in place in the human body part.
  • Fig. la, b and c show an embodiment of the invention in a cross-sectional view, a plan view and a side view, respectively.
  • Fig. 2a, b, c and d show different embodiments having a rim in a cross-sectional view and two plan views, respectively.
  • Fig. 3a-g show different embodiments of the invention in cross-sectional views.
  • Fig. 4a and b show embodiments of different shapes from the side.
  • Fig. 5a and b show embodiments with different shapes in a plan view.
  • Fig. 6a, b and c show different embodiments of mandrels for the production of embodi ments of the invention.
  • Fig. 7 shows an example of a use of the invention.
  • Fig. 8 shows an example of a use of the invention.
  • the medical support device 1 comprises at least a wall shaped portion 2. It has a first side 3, which shows a bulge out of a plane 4 and a second side 5 that has a correspond- ing cavity.
  • the wall shaped portion 2 may have a dome shape, although it is possible to have any particular shape according to the purpose of the supporting in the human body.
  • the wall shaped portion 2 is curved over at least two different thought axes or draped, i.e. it does not have shape of a partial cylinder. Preferably it has a thickness between the first side 3 and the second side 5 which is more or less the same over the bulge/cavity.
  • the medical support device 1 is shown in a plan view from the first side 2. In the shown embodiment the device has a more or less circular footprint, although any shape would be possible.
  • Fig. lc the embodiment of Fig. la and b is shown from the side.
  • the medical support device 1 is for supporting endogenous tissue and/or fat in place in a human body part.
  • any suitable body part may receive the medical support device 1, such as in the buttocks or breasts, although it would probably be mostly used in women's breasts.
  • the medical device 1 will support endogenous tissue or fat or both against gravitational pull. It is also conceivable to add other materials suitable to be in a human body, such as hyalu ronic acid. Or only use other material or materials in the cavity portion of the medical sup port device 1.
  • the medical support device 1 comprises either an elastomer or matrix, or both.
  • the elasto- mer material may be of any kind suitable to be used with a human body and being pliable.
  • the elastomer may for example be a silicon rubber, preferably of the type used in breast implants.
  • the matrix may be built up by biological or synthetic materials or a combination thereof. It could comprise absorbable and/or non-absorbable material. For example, it could be an acellular dermal matrix.
  • a medical support device 1 in cross section where at least a portion of a rim 6 is provided at an edge 7 of the cavity or bulge in the plane 4.
  • the at least one portion of the rim 6 may be more easily attached to tissue in a human body than attaching only an edge 7.
  • any suture may be used for this, absorbable or not.
  • FIG. 2b an embodiment is shown in a plan view where several portions of the rim 6 is provided and in Fig. 2c a full rim 6 surrounding the edge 7 is shown.
  • Fig. 2d another em bodiment is shown where the wall shaped portion 2 is cut off 8 in its upper portion and having a rim 6 around the edge 7 left in the plane 4 so that a pocket is formed when attached to tissue in the human body. All the shown embodiment in Fig. 2 may comprise an elastomer and/or matrix.
  • Figs. 3a-g Different embodiments of how a combination of an elastomer and matrix will now be ex- emplified in Figs. 3a-g.
  • Fig. 3a a dome-shaped medical support device 1 is shown made of elastomer and having a portion of matrix 9 provided on the second side 5 in the lower region.
  • matrix 9 may be provided all over the second side 5 or, as shown in Fig. 3b, all over the first side 3, or over a portion of the first side 3.
  • Fig. 3c a medical support device 1 having a rim 6 is shown where matrix 9 is provided at the rim 6 on the same side as the second side 5 of the wall shaped portion 2. It is also conceivable to have matrix 9 on the other side, as is shown in Fig.
  • matrix 9 is provided both in the cavity, the second side 5, and at the rim 6.
  • matrix 9 is provided on a lower portion of the cavity and bulge, respectively, as well as along the rim 6.
  • the shape of the medical support device 1 may differ according to its use and purpose.
  • a more or less dome-shape is shown, preferably a partial sphere, and in Fig. 4b an anatomical shape is shown.
  • the projection may differ, too, as well as the height of a projection point 12.
  • the footprint of the medical support device 1 may also differ ac cording to its use and purpose.
  • Fig. 5a and 5b two different examples are shown, circular having the same height as width; or having different height compared to the width, respec- tively. The height may be longer than the width or vice versa.
  • the footprint may be oval or as shown in Fig. 5b, drop shaped.
  • a medical support device 1 may be produced.
  • Fig. 6a, b and c three different mandrels are shown.
  • the mandrel is dipped in an elastomer in a flowing condition. Then it is taken up and the elastomer hardens into a pliable condition. This could be effectuated by means of heat or added substances, for example.
  • the dipping usually is repeated a desired number of times.
  • the elastomer is taken off the mandrel, and if needed cut to desired shape. It is possible to turn it inside out, i.e. the surface of the elastomer closest to the mandrel will instead become the bulge side, the first side 3.
  • a special surface such as a textured surface
  • Different roughness from fine to coarse may be provided by having a surface structure on the mandrel.
  • a rim 6 a mandrel according to Figs. 6b and 6c may be used.
  • a combination of elastomer and matrix parts of matrix may be arranged at the mandrel at desired positions, or over the full mandrel surface, before the dipping. Alternatively, the matrix is arranged after the dipping before hardening.
  • the medical support device 1 may be provided in a range of sizes making it possible to find a suitable size for the special needs of each patient.
  • a use of the medical support device 1 is shown.
  • the medical support device 1 is positioned inside a human body part 10, in this case a female breast.
  • the deep gland tissue and/or fat is separated and a portion of it is provided inside of the cavity, i.e. on the second side 5 of the medical support device 1.
  • the medical support device is attached with sutures 11.
  • the sutures are preferably of the absorbable type.
  • the medical support device may for example be attached in a muscle, the breast muscle in the shown case. It is also conceivable to provide fat or other tissue, preferably endogenous, within the cavity of the medical support device in addition to gland tissue or only fat or only other tissue.
  • hyaluronic acid or other medical injectable material in the cavity, alone or mixed with endogenous tissue of any or several kinds.
  • Fig. 8 it is shown the possibility to add, for example hyaluronic acid or fat, by means of a syringe into a cavity of a medical support device already in place in a human body part 10. This puncturing will not do any harm as no harmful material may leak out as it would with a common breast implant filled with silicone gel.

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  • Health & Medical Sciences (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Public Health (AREA)
  • Oral & Maxillofacial Surgery (AREA)
  • Transplantation (AREA)
  • Veterinary Medicine (AREA)
  • Animal Behavior & Ethology (AREA)
  • General Health & Medical Sciences (AREA)
  • Engineering & Computer Science (AREA)
  • Biomedical Technology (AREA)
  • Chemical & Material Sciences (AREA)
  • Heart & Thoracic Surgery (AREA)
  • Vascular Medicine (AREA)
  • Cardiology (AREA)
  • Dermatology (AREA)
  • Medicinal Chemistry (AREA)
  • Epidemiology (AREA)
  • Chemical Kinetics & Catalysis (AREA)
  • Molecular Biology (AREA)
  • Urology & Nephrology (AREA)
  • Zoology (AREA)
  • Botany (AREA)
  • Prostheses (AREA)
  • Materials For Medical Uses (AREA)

Abstract

A medical support device (1 ), for use in a woman's breast as an implant without incapsulated material, wherein the medical support device (1) comprises at least a wall shaped portion (2) having a first side (3), which shows a bulge out of a plane (4), and a second side (5) of the wall shaped portion (2) has a corresponding cavity, for example a dome shape, wherein the medical support device (1) comprises an elastomer. The device will keep endogenous tissue and/or fat and/or added material, such as hyaluronic acid, in place inside of deep gland tissue of a woman's breast by means of being attached to tissue, such as muscle. A method of producing and to use such a medical support device (1 ).

Description

A MEDICAL SUPPORT DEVICE
The present invention concerns a medical support device for use in a human body part, a method of producing it and to use it.
Background
Previously are implants filled with a filling, such as silicone gel or saline, known. There is always a risk of leakage of the filling or encapsulating of the implant. It is also known to use a matrix to support an implant within a human body part, the matrix may be absorbable or not by the human body.
Summary of the invention
The aim of the present invention is to be able to support and/or augment a human body part without the previously known drawbacks.
According to a first aspect of the invention a medical support device, for use in a human body part is provided. The device comprises at least a wall shaped portion having a first side, which shows a bulge out of a plane, and a second side of the wall shaped portion has a corresponding cavity, for example as a dome shape, wherein the medical support device comprises an elastomer. The wall shaped portion is curved around more than one axis or has a draped shape. The medical support device is open from the plane into the cavity, i.e. never closed such as, for example, a common breast implant filled with liquid silicone gel or saline.
With the medical support device according to the invention it will be possible to keep en dogenous tissue and/or fat and/or added material, such as hyaluronic acid in place in the human body part. An advantage with this solution is that it will be permeable for x-ray ra diation when filled with endogenous tissue and/or fat, which is important for secure mam- mography. According to an embodiment the wall thickness, i.e. between the first side and second side, is more or less the same over the wall shaped portion. Preferably, the medical support is pre-shaped. According to an embodiment a rim in the plane is at least partially present along an edge of the cavity. The rim will make it easier to apply sutures to the medical support device when fastening it to the tissue of the body part. Attaching the medical support device will in turn lead to less problems with malpositioning, such as rotation, and lateral and bottoming out movement of the implant. It will also make sure the material in the cavity of the medical support device stays in place.
According to an embodiment the device is made of an elastomer and provided with a matrix at least at the rim. According to an embodiment the device is made of an elastomer and provided with a matrix at least partially at the second side, cavity side, of the wall shaped portion.
According to an embodiment device is used in a breast, preferably in a woman's breast. According to a second aspect of the invention a method of producing a medical support device provided, whereby a mandrel having a desired shape is dipped in an unhardened elastomer to shape the device. Preferably at least a piece of matrix is arranged on the man drel before or on the device after the dipping. According to a third aspect of the invention a method of using such a medical support device according is provided. An implant without incapsulated material is formed, where the med ical support device keeps endogenous tissue and/or fat and/or added material, such as hy aluronic acid, in place in the human body part. Short description of drawings
The present invention will now be described in more detail under referral to the enclosed drawings, in which:
Fig. la, b and c show an embodiment of the invention in a cross-sectional view, a plan view and a side view, respectively.
Fig. 2a, b, c and d show different embodiments having a rim in a cross-sectional view and two plan views, respectively.
Fig. 3a-g show different embodiments of the invention in cross-sectional views.
Fig. 4a and b show embodiments of different shapes from the side.
Fig. 5a and b show embodiments with different shapes in a plan view.
Fig. 6a, b and c show different embodiments of mandrels for the production of embodi ments of the invention.
Fig. 7 shows an example of a use of the invention.
Fig. 8 shows an example of a use of the invention.
Detailed description of embodiments of the invention
In Fig. la, b and c an embodiment of a medical support device 1 of the present invention is shown. The medical support device 1 comprises at least a wall shaped portion 2. It has a first side 3, which shows a bulge out of a plane 4 and a second side 5 that has a correspond- ing cavity. For example, the wall shaped portion 2 may have a dome shape, although it is possible to have any particular shape according to the purpose of the supporting in the human body.
The wall shaped portion 2 is curved over at least two different thought axes or draped, i.e. it does not have shape of a partial cylinder. Preferably it has a thickness between the first side 3 and the second side 5 which is more or less the same over the bulge/cavity. In Fig. lb the medical support device 1 is shown in a plan view from the first side 2. In the shown embodiment the device has a more or less circular footprint, although any shape would be possible. In Fig. lc the embodiment of Fig. la and b is shown from the side. The medical support device 1 is for supporting endogenous tissue and/or fat in place in a human body part. Any suitable body part may receive the medical support device 1, such as in the buttocks or breasts, although it would probably be mostly used in women's breasts. The medical device 1 will support endogenous tissue or fat or both against gravitational pull. It is also conceivable to add other materials suitable to be in a human body, such as hyalu ronic acid. Or only use other material or materials in the cavity portion of the medical sup port device 1.
The medical support device 1 comprises either an elastomer or matrix, or both. The elasto- mer material may be of any kind suitable to be used with a human body and being pliable. The elastomer may for example be a silicon rubber, preferably of the type used in breast implants. The matrix may be built up by biological or synthetic materials or a combination thereof. It could comprise absorbable and/or non-absorbable material. For example, it could be an acellular dermal matrix.
In Fig. 2a an embodiment of a medical support device 1 is shown in cross section where at least a portion of a rim 6 is provided at an edge 7 of the cavity or bulge in the plane 4. The at least one portion of the rim 6 may be more easily attached to tissue in a human body than attaching only an edge 7. Preferably, any suture may be used for this, absorbable or not.
In Fig. 2b an embodiment is shown in a plan view where several portions of the rim 6 is provided and in Fig. 2c a full rim 6 surrounding the edge 7 is shown. In Fig. 2d another em bodiment is shown where the wall shaped portion 2 is cut off 8 in its upper portion and having a rim 6 around the edge 7 left in the plane 4 so that a pocket is formed when attached to tissue in the human body. All the shown embodiment in Fig. 2 may comprise an elastomer and/or matrix.
Different embodiments of how a combination of an elastomer and matrix will now be ex- emplified in Figs. 3a-g. In Fig. 3a a dome-shaped medical support device 1 is shown made of elastomer and having a portion of matrix 9 provided on the second side 5 in the lower region. Obviously, matrix 9 may be provided all over the second side 5 or, as shown in Fig. 3b, all over the first side 3, or over a portion of the first side 3. In Fig. 3c a medical support device 1 having a rim 6 is shown where matrix 9 is provided at the rim 6 on the same side as the second side 5 of the wall shaped portion 2. It is also conceivable to have matrix 9 on the other side, as is shown in Fig. 3f or on both sides. In Fig. 3d matrix 9 is provided both in the cavity, the second side 5, and at the rim 6. In Fig. 3e and 3g matrix 9 is provided on a lower portion of the cavity and bulge, respectively, as well as along the rim 6.
Obviously, the shape of the medical support device 1 may differ according to its use and purpose. In fig. 4a a more or less dome-shape is shown, preferably a partial sphere, and in Fig. 4b an anatomical shape is shown. The projection may differ, too, as well as the height of a projection point 12. The footprint of the medical support device 1 may also differ ac cording to its use and purpose. In Fig. 5a and 5b two different examples are shown, circular having the same height as width; or having different height compared to the width, respec- tively. The height may be longer than the width or vice versa. For example, the footprint may be oval or as shown in Fig. 5b, drop shaped.
Now examples of how a medical support device 1 may be produced will be described. In Fig. 6a, b and c three different mandrels are shown. The mandrel is dipped in an elastomer in a flowing condition. Then it is taken up and the elastomer hardens into a pliable condition. This could be effectuated by means of heat or added substances, for example. The dipping usually is repeated a desired number of times. The elastomer is taken off the mandrel, and if needed cut to desired shape. It is possible to turn it inside out, i.e. the surface of the elastomer closest to the mandrel will instead become the bulge side, the first side 3.
In case a special surface is desired, such as a textured surface, it is possible to provide it on the first side 3 or second side 5, respectively, or on both sides. Different roughness from fine to coarse may be provided by having a surface structure on the mandrel. It is also pos sible to imprint a texture on the outermost layer, before hardening. For example, it is pos- sible to use polyurethane or a salt to imprint. If a rim 6 is desired a mandrel according to Figs. 6b and 6c may be used. If a combination of elastomer and matrix is desired parts of matrix may be arranged at the mandrel at desired positions, or over the full mandrel surface, before the dipping. Alternatively, the matrix is arranged after the dipping before hardening.
The medical support device 1 may be provided in a range of sizes making it possible to find a suitable size for the special needs of each patient.
In Fig. 7 a use of the medical support device 1 is shown. The medical support device 1 is positioned inside a human body part 10, in this case a female breast. In the present case the deep gland tissue and/or fat is separated and a portion of it is provided inside of the cavity, i.e. on the second side 5 of the medical support device 1. The medical support device is attached with sutures 11. The sutures are preferably of the absorbable type. The medical support device may for example be attached in a muscle, the breast muscle in the shown case. It is also conceivable to provide fat or other tissue, preferably endogenous, within the cavity of the medical support device in addition to gland tissue or only fat or only other tissue. It is also conceivable to add hyaluronic acid or other medical injectable material in the cavity, alone or mixed with endogenous tissue of any or several kinds. In Fig. 8 it is shown the possibility to add, for example hyaluronic acid or fat, by means of a syringe into a cavity of a medical support device already in place in a human body part 10. This puncturing will not do any harm as no harmful material may leak out as it would with a common breast implant filled with silicone gel.

Claims

1. A medical support device, for use in a woman's breast as an implant without incap- sulated material, wherein the device comprises at least a wall shaped portion having a first side, which shows a bulge out of a plane, and a second side of the wall shaped portion has a corresponding cavity, for example as a dome shape, the medical sup port device comprises an elastomer , the device will keep endogenous tissue and/or fat and/or added material, such as hyaluronic acid, in place inside of deep gland tis sue of the woman's breast by means of being attached to tissue, such as muscle.
2. The medical support device according to claim 1, wherein a matrix is comprised in the medical support device.
3. The medical support device according to claim lor 2, wherein a rim in the plane is at least partially present along an edge of the cavity of the wall shaped portion.
4. The medical support device according to claim 3, wherein the device is made of an elastomer and provided with a matrix at least at the rim.
5. A method of producing a medical support device according to claim 1, whereby a mandrel having a desired shape is dipped in an unhardened elastomer one or several times and hardened in order to shape the medical support device.
6. The method according to claim 5, whereby at least a piece of matrix is arranged on the mandrel or on the device after the dipping.
7. A method of using a medical support according to any of the preceding claims, wherein an implant without incapsulated material is formed, where the medical sup port device keeps endogenous tissue and/or fat and/or added material, such as hy aluronic acid, in place in the human body part.
PCT/SE2020/050579 2019-06-13 2020-06-09 A medical support device WO2020251454A1 (en)

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EP20823250.4A EP3982878A4 (en) 2019-06-13 2020-06-09 A medical support device
US17/618,113 US20220346940A1 (en) 2019-06-13 2020-06-09 A medical support device
CN202080043451.7A CN113966208A (en) 2019-06-13 2020-06-09 Medical support device
AU2020290877A AU2020290877A1 (en) 2019-06-13 2020-06-09 A medical support device
IL288902A IL288902B2 (en) 2019-06-13 2020-06-09 A medical support device
CA3140990A CA3140990A1 (en) 2019-06-13 2020-06-09 A medical support device
KR1020217041957A KR20220024150A (en) 2019-06-13 2020-06-09 medical aid organization
BR112021025134A BR112021025134A2 (en) 2019-06-13 2020-06-09 A medical support device
JP2021574187A JP7520057B2 (en) 2019-06-13 2020-06-09 Medical Support Devices

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SE1950712A SE544434C2 (en) 2019-06-13 2020-06-09 A medical support device for use as a breast implant

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IL288902B2 (en) 2024-05-01
AU2020290877A1 (en) 2022-01-20
BR112021025134A2 (en) 2022-01-25
SE544434C2 (en) 2022-05-24
SE1950712A1 (en) 2020-12-14
CN113966208A (en) 2022-01-21
IL288902A (en) 2022-02-01
IL288902B1 (en) 2024-01-01
JP7520057B2 (en) 2024-07-22
EP3982878A4 (en) 2022-07-20
EP3982878A1 (en) 2022-04-20
AU2020290877A2 (en) 2022-01-27
JP2022537945A (en) 2022-08-31
US20220346940A1 (en) 2022-11-03
KR20220024150A (en) 2022-03-03
CA3140990A1 (en) 2020-12-17

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