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
  • A61F2/02—Prostheses implantable into the body
  • A61F2/12—Mammary prostheses and implants
• • 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
  • A61F2/0059—Cosmetic or alloplastic implants
• • 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
  • A61F2230/00—Geometry of prostheses classified in groups A61F2/00 - A61F2/26 or A61F2/82 or A61F9/00 or A61F11/00 or subgroups thereof
  • A61F2230/0002—Two-dimensional shapes, e.g. cross-sections
  • A61F2230/0028—Shapes in the form of latin or greek characters
  • A61F2230/0043—L-shaped
• • 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
  • A61F2230/00—Geometry of prostheses classified in groups A61F2/00 - A61F2/26 or A61F2/82 or A61F9/00 or A61F11/00 or subgroups thereof
  • A61F2230/0002—Two-dimensional shapes, e.g. cross-sections
  • A61F2230/0028—Shapes in the form of latin or greek characters
  • A61F2230/0054—V-shaped
• • 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
  • A61F2250/0037—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 height or in length

Definitions

• This invention relates to a soft tissue support, including but not limited to a human mammary support.
• Soft tissue such as human breasts
• Soft tissue is prone to sagging with age. This is caused by a weakening of the support structures of the relevant soft tissue.
• the support structure includes ligaments and the breast skin.
• each breast supports the breast by suspending it from the area around the collarbone above the breast. With ageing, the skin looses its elasticity and stretches. Ligaments that support the breast tissue internally also loose some of its resilience because of ageing. The combination of loss of resilience of the ligaments and loss of elasticity and stretching of the breast skin causes the breast support structure to be compromised. This leads to deformation of the shape of the breast, which is referred to as breast ptosis. In effect the weight of the breast tissue deforms the shape of the breast.
• Some breast prostheses have been developed to treat aesthetic problems associated with ageing breasts. These include normal breast augmentation implants which do not address the problem of breast ptosis but merely add volume to the breast. In some instances this may have beneficial effects. However a breast augmentation implant does not lift a breast, but rather pushes it forward. If the patient already has breast ptosis, an augmentation implant merely pushes the sagged breast outward and does not lift it.
• FR2682284 (Dessart); FR2746298 (Bellity); US4840629 (Silimed Silicone E lnstr Medic); WO9704722 (Pignataro); and US5217494 (Coggins et al).
• a common problem with the prior art prostheses is that the prosthesis is implanted in a manner which secures the prosthesis between the skin and breast tissue in a manner which makes revision very difficult. Compounding this problem is the fact that most of these prostheses have to be implanted by means of relatively invasive procedures, which makes revision using the existing prosthesis very difficult.
• a further problem is that it is in some instances very difficult for a surgeon to manipulate the shape of a breast after the prosthesis has been implanted. It is also very difficult for the surgeon to vary manipulate the locations at which the prosthesis is secured. This could have been useful to modify the shape of the breast, which means that a surgeon does not have a significant scope to modify the shape of the breast.
• the surgeon simply attaches the prosthesis to its various attachment locations and the shape of the breast is then determined by factors outside the control of the surgeon. This often results in less than satisfactory results.
• a further very practical problem of the prior art breast prostheses is that these do nothing to shape the breast per se other than supporting it against the breast muscle.
• the prior art prostheses can at best be likened to a very tight sports top which squashes the breasts and thereby prevents movement without allowing the breasts to take on a natural ideal shape.
• a mammalian soft tissue support comprising a biocompatible resilient layer with a predetermined shape including means to secure the support subcutaneously.
• the layer to include means for the support to be operatively securable to the breast bone or second chondro-stemal junction of the recipient.
• the layer comprises a mesh of resilient elongate members, preferably a mesh of circular cross section strand, further preferably a polypropylene strand.
• the means to secure the support to the recipient to comprise suture, preferably non-dissolvable suture, extended through the fascia at the level of the second intercostal space, to which the support is secured and around at least one strand of mesh .
• the mesh prefferably be generally L-shaped, alternatively U-shaped, and to include an operatively lateral leg and an operatively medial leg, and further preferably for the lateral leg to be wider than the medial leg.
• the support to include at least one marking on the support which indicates a cut line to reshape the support operatively.
• marking is further provided for the marking to be located substantially parallel to the edge of the support to define a reshaped support having a predetermined size smaller than the support.
• the support to include a plurality of predefined markings with each marking indicating a unique cut line.
• marking is also provided for the marking to be heat sealed to provide, operatively, an edge after cutting through which the support is securable subcutaneously.
• a soft tissue support system comprising a soft tissue support as defined above with an associated complimentary template, for the template to be substantially impermeable to body fluids.
• Figure 1 shows a plan view of a female breast support according to the invention
• Figure 2 shows a female breast after a peri areola incision has been made into it to enable implanting of the prosthesis of Figure 1
• Figure 3 shows the breast of Figure 2 with the skin surrounding the areola stretched to allow access to the breast tissue and with a template of the prosthesis placed in position on the breast tissue;
• Figure 4 shows the prosthesis after it has been placed on the template and has been secured to the fascia of the second intercostal rib and the breast tissue;
• Figure 5 shows the template being withdrawn from underneath the prosthesis
• Figure 6 shows the prosthesis after the template has been removed from underneath it;
• Figure 7 shows a section through a recipient of the prosthesis skin and breast tissue;
• Figure 8 shows the incisions for an alternative procedure to implant the prosthesis;
• Figure 9 shows the incisions for another alternative procedure to implant the prosthesis.
• the support (1) is shaped and configured to support, operatively, a human female breast.
• the support (1) as shown in Figure 1 , comprises a generally L-shaped layer of biocompatible resilient mesh (2).
• the L-shaped support (1) includes a lateral leg (3) and medial leg (4), of which the lateral leg (3) is slightly wider than the medial leg (4).
• the mesh (2) includes heat sealed periphery (5).
• the mesh (2) is a synthetic mesh, in this embodiment manufactured from polypropylene.
• the mesh (2) includes a diamond shaped openwork structure (6) and each strand (7) of the mesh (2) is manufactured of polypropylene.
• the support (1) is operatively arranged such that the long dimension of each of the diamonds in the shaped openwork structure (6) is orientated substantially from top to bottom relatively to the recipient's body, and the short dimension of each diamond of the openwork structure (6) is orientated substantially across the mesh (2), in other words operatively horizontally.
• the orientation of the strands (7) in the diamond shaped openwork structure (6) allows the support (1) to provide more support in the vertical direction than in the horizontal direction.
• the long dimension of the diamond shaped openwork structure (6) resists deformation more than deformation is resisted in the short dimension. This enables the support (1) to resist gravity which normally contributes to sagging of a breast, but still allows the breast to expand naturally as would be the case during, for example, breast swelling because of the female menstrual cycle.
• the surgeon needs to expose the breast tissue.
• the type of procedure used depends of the size of the patient's breasts and the amount of ptosis or sagging of the breasts present.
• Patients with a breast cup size of between a size B and a size C and which have relatively little ptosis can have the support (1) implanted through a peri areola access point, i.e. an incision (8) which is made around the areola (9) as is shown in Figure 2.
• the skin (10) is stretched open to allow access to the underlying breast tissue (11).
• Patents with cup sizes of C and above and which experience large amounts of ptosis normally need to have a breast reduction in conjunction with the implanting of the support (1).
• a surgeon normally needs greater access than what the previously mentioned procedures allow.
• a peri areola incision (16) is made, followed by an incision (17) downwards to the infra- mammary crease and an incision (18) in the infra-mammary crease, as is shown in Figure 9.
• This allows the skin to be flapped open to allow adequate access to the breast tissue for the reduction and the implanting of the support (1) afterwards.
• the procedure is started by making the peri areola incision (8).
• the general construction of the tissue which forms the female breast is shown schematically in Figure 7. It can be seen that underneath the skin (19) there is a layer of fat (20), then the breast gland (21) and finally the breast muscle (22).
• the aim of the procedure is to implant the support (1) in the layer of fat (20).
• the support (1) cannot be implanted directly underneath the skin (19) since that will create the risk that the some of the strands (7) of the mesh may be extruded through the skin (19).
• the support (1) is also not implanted directly onto the breast gland (21) since implanting it at that level means the surgeon has to dissect the fatty tissue (20) from the gland, which is to be avoided if possible.
• the fatty tissue (20) is therefore dissected into two layers, a first (20A) which is left attached to the skin (19) and a second (20B) which is left to cover the breast gland (21).
• the fatty tissue grows into the mesh (2) to incorporate it into the breast tissue.
• the layer of fat (20) is dissected up to the medial side of the breast to the height of about the second intercostal space (23) and around the breast (24). This exposes a layer of fat covering the breast gland over which the support (1) is to be secured.
• the support (1) forms part of a system which is used by a surgeon to implant it.
• the system includes the support (1) and a complimentary template (25), which is manufactured from a sterilised layer of plastics material.
• the template (25) matches the shape of the support (1) precisely, allowing the edges of the support (1) to be extend marginally over the edges of the template (25) when the support (1) is placed onto the template (25).
• the template (25) is used by a surgeon to determine the most appropriate position for the support (1) on the breast tissue.
• the template (25) is manufactured from a resilient plastics material which is not affected by contact with body fluids. As shown in Figure 3, the template (25) is used to capture the breast tissue after it has been exposed. The end (29) of the medial leg (26) of the template (25) is placed in position where the support (1) will be secured, i.e. typically over the second intercostal space (23).
• the base (27) of the L-shaped template (25) is then extended below the breast tissue to capture it and the end (30) of the lateral leg (28) is placed over the end (29) of the medial leg (26) of the template (25).
• the lateral leg (28) is wider than the medial leg (26) which allows it to support breast tissue which may extend to underneath the armpit of the patient.
• the end (30) of the lateral leg (28) may be extended over the end (29) of the medial leg (26), which allows the surgeon to shape the breast (24).
• the support (1) is placed over the template (25), which is held in place and at the desired orientation at the same time merely by sticking to the body fluid from the fatty tissue (20B) underneath it.
• the support (1) is then secured to the selected intercostal space (23) by suture (32) which is extended through the end (35) of the medial leg (36) of the support (1) and the fascia of the intercostal space (23).
• the body of the support (1) is then secured to the breast tissue underneath the template by surgical staples (33) through the edge (34) of the support (1) into the fatty tissue (20B) underneath it.
• the end (37 of the lateral leg (38) of the support (1) is finally sutured to the selected intercostal space (23) and the end (35) of the medial leg (36) underneath it.
• the support (1) is secured in the patient's breast without allowing it to come in complete contact with body fluid of the patient until it has been secured in place.
• the template (25) also aids the implanting by providing the surgeon with a device to determine the size of the support (1) that is needed. It is possible for the surgeon to cut the template (25) to the correct size to determine the best fit before the support (1) is implanted. Once the correct size has been determined, the support (1) may be cut to the same size as the template before implanting the support (1 ).
• the template (25) is removed from underneath the support (1). This is done by pulling the template (25) through the opening left along the inside edge of the support (1) around the areola (9), as is shown in Figure 5.

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)
• Materials For Medical Uses (AREA)

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• 2006
  • 2006-04-28 CA CA 2606969 patent/CA2606969C/en not_active Expired - Fee Related
  • 2006-04-28 WO PCT/IB2006/001056 patent/WO2006117622A1/en active Application Filing
  • 2006-04-28 MX MX2007013295A patent/MX2007013295A/es unknown
  • 2006-04-28 AU AU2006242962A patent/AU2006242962B2/en not_active Ceased
  • 2006-04-28 EA EA200702373A patent/EA013782B1/ru not_active IP Right Cessation
  • 2006-04-28 KR KR20077027855A patent/KR20080007485A/ko not_active Application Discontinuation
  • 2006-04-28 JP JP2008508330A patent/JP4782824B2/ja not_active Expired - Fee Related
  • 2006-04-28 NZ NZ563828A patent/NZ563828A/en not_active IP Right Cessation
  • 2006-04-28 BR BRPI0610761-3A patent/BRPI0610761A2/pt not_active IP Right Cessation
  • 2006-04-28 EP EP20060744592 patent/EP1898838A1/de not_active Withdrawn
• 2007
  • 2007-10-29 IL IL186995A patent/IL186995A0/en unknown
  • 2007-11-27 ZA ZA200711206A patent/ZA200711206B/xx unknown
  • 2007-11-28 NO NO20076154A patent/NO20076154L/no not_active Application Discontinuation

Non-Patent Citations (1)

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