JP2009268861A - Breast mesh implant - Google Patents

Abstract

<P>PROBLEM TO BE SOLVED: To provide a breast mesh implant used by putting it into the breast for compensating a tissue defect part after excision of a lesion such as mammary gland tumor including breast cancer to maintain the cosmetic. <P>SOLUTION: The breast mesh implant is used by implanting it between the greater pectoral muscle and the breast skin. The breast mesh implant is formed of two sheets 1, 2 with perforations and a bag 3 set therebetween. Liquid of saline etc. is put into the bag 3 from outside adjusting its amount according to the size of the tissue defect to compensate the defect part by filling the tissue defect part so as to reduce deformation after operation. <P>COPYRIGHT: (C)2010,JPO&INPIT

Description

  The present invention relates to a breast mesh implant that is used in a breast in order to compensate for a tissue defect after excision of a lesion, such as a mammary tumor including a breast cancer, and to maintain tonicity.

Conventionally, in the case of various mammary tumors such as breast cancer, in many cases, an operation for excising the mammary gland tissue at the lesion of the breast has been performed. After surgery, various degrees of breast deformation are unavoidable, and various surgical techniques have been devised to maintain the suitability, such as undergoing breast reconstruction after surgery, but it is cumbersome and requires skill. Not so common. Breast reconstruction has been conventionally performed using breast filling, own skin, adipose tissue, muscles, and the like. In addition, as an artificial filling that is currently widely used to compensate for the breast defect,
a) Silicon rubber sealed with silicon gel,
b) A silicone rubber sealed with sterile physiological saline,
c) Silicon gel is enclosed in an inner bag of silicon rubber, which is further housed in an outer bag of silicon rubber in which physiological saline is enclosed, and d) solidified silicon e) shaped mesh And so on.
However, a) has been pointed out that there is a risk that silicon gel will flow out due to leaching or rupture of silicon rubber, which will have various adverse effects on the human body. In b), volume leakage due to leakage of the filler and rupture of the silicone rubber causes deterioration of breast conformity. Further, c) reduces the risk of leakage and rupture of the contents silicon of a), but the risk of foreign material injection remains. In d), the influence of silicon itself on the living body remains. Even though these problems are solved, e) is difficult to obtain symmetry compared to the non-resected mammary gland because of the shaped mesh.
In addition, the following patent document can be mention | raise | lifted as a well-known technique relevant to this invention.

  JP-A-57-136447   JP-A 62-5342   JP-A-1-190352   JP 2004-130118 A   JP 2005-137398 A

As for the treatment of breast cancer, due to the recent medical progress and the increasing awareness of QOL, the mainstream is not the whole mammary gland but the partial resection including the lesion and the breast preservation consisting of regional lymph node cleansing. However, although it is a partial resection, the shape may be worse than expected due to deformation in the healing process after surgery. For this purpose, it is necessary to re-operate and replenish the defect created by resection of the mammary gland by transplanting the skin, adipose tissue, muscle, and the like. This is not necessarily preferable because it causes a patient's mental pain and financial burden.

The present invention relates to an implantable artificial breast filling used to treat a mammary gland disease including breast cancer to compensate for a defect in a mammary tissue after the mammary gland has been removed and to prevent various deformations. The purpose is to provide. More specifically, an object of the present invention is to provide a mammary gland filling that is used by being embedded in a mammary gland tissue defect between the pectoralis major muscle and the breast skin produced by mammectomy. In particular, an object of the present invention is to provide a breast filling used for filling a mammary defect after a breast-conserving operation.

  The present invention has been intensively studied to solve the above problems, and has a breast filling comprising a porous sheet (mesh sheet) having the following specific configuration and a bag (hereinafter referred to as “breast filling”). According to "Mesh Implant"), it was found that the above problems can be solved. The present invention has been developed based on such knowledge.

That is, the present invention is a breast mesh implant listed in items 1 to 3 below:
Item 1. A breast mesh implant having at least two perforated sheets and a bag interposed between the front of the greater pectoral muscle and the back of the breast skin.
Item 2. An injection part is installed in the back adhesive part of the mesh sheet on the back of the breast skin so that injection of a liquid such as physiological saline can be adjusted from outside the body.
Item 3. To inject the contents of the bag, a reservoir for injecting liquid from outside the body can be connected to the bottom of a mesh sheet bag placed on the front of the pectoralis major muscle.
Item 4. 2. The breast mesh implant according to claim 1, wherein the mesh sheet of the implant has a second sheet attached to the bottom of the bag, and the two sheets can more firmly replenish and fix the tissue defect. 3. .

Further, the present invention is a breast mesh implant listed in the following item 5:
Item 5. A breast mesh implant having a bag used by embedding in a mammary gland tissue defect caused by surgery between the pectoral muscles and the breast skin, and a liquid such as physiological saline in the bag according to the volume of the deficient tissue Breast mesh implants that can be injected while being adjusted to maintain postoperative stability.

  These breast mesh implants described in each of items 1 to 5 above are breast fillings that are used by being embedded in a tissue defect caused by mammectomy in breast-conserving surgery or the like.

  The present invention is described in detail below.

  The breast mesh implant of the present invention is characterized in that it is formed from a porous sheet and a bag adhered to the sheet.

  The shape of the porous sheet (mesh sheet) used in the present invention is not particularly limited as long as it is porous. Specific examples include a porous film and a net (network) made of monofilament or multifilament, woven fabric, or woven fabric. The mesh sheet is preferably made from a filament in terms of stretchability, and more preferably a mesh-like mesh sheet (knitted mesh sheet) in terms of elasticity. The network structure is not particularly limited, but it is preferable to have a network structure having stretchability with respect to the sheet parallel plane and elasticity with respect to the sheet vertical direction. As an example of such a mesh structure, weft stitches such as flat knitting, rubber knitting and pearl knitting, and tricot knitting. Examples thereof include warp stitches such as Raschel knitting and Miranese knitting, but are not limited thereto, and preferred examples thereof include a warp stitch structure from the viewpoint of elasticity in the sheet vertical direction.

  The material of the porous sheet constituting the breast mesh implant of the present invention is only required to be biocompatible, and there is no particular limitation on whether it is biodegradable (absorbable) or non-biodegradable (nonabsorbable). . Non-biodegradable (non-absorbable) materials include, for example, polyamide (eg, polyhexamethylene adipamide (nylon 66), polyhexamethylene sebamide (nylon 610), polycabramide (nylon 6), polydodecanamide (nylon 12). ), And polyhexaimethylene isophthalamide (nylon 61), copolymers and mixtures thereof), polyesters (eg, polyethylene terephthalate, polybutyl terephthalate, polybutyl terephthalate, copolymers and mixtures thereof), fluoropolymers (For example, polytetrafluoroethylene), polyolefin (for example, a mixture mainly composed of isotactic and syndiotactic polypropylene), and the like can be exemplified. Polyester, polytetrafluoroethylene, expanded polytetrafluoroethylene, and polypropylene are preferable, and polypropylene is more preferable.

  Biodegradable (absorbable) materials include glycolide, lactide (L-, D-, and meso-form lactide and mixtures thereof, e-caprolactone, p-dioxanone, trimethylene carbonate, 1,4,4 -Conventionally known materials such as dioxeban-2-one, poly (alkylene oxalate) and a mixture of these polymers), and materials to be developed in the future can be exemplified without limitation. More specifically, various materials currently used for absorbable sutures. For example, cut gut (natural material), polyglycolic acid (synthetic material: for example, trade name Dexon, Keiseipondek, and opepolix, etc.), poglactin (synthetic material: for example, trade name Bicyclyl, etc.) polyglyconate (synthetic material: for example, Trade name maxon etc.) and polydioxanone (synthetic material: trade name PDS, for example).

  The breast mesh implant of the present invention may be composed of the same or different porous sheet (mesh sheet) as long as it has biocompatibility. For example, even if it is a combination of a sheet made of a biodegradable (absorbable) material and a sheet made of a non-biodegradable (non-absorbable) material, the mesh structure (porous structure) or pore size It may consist of a combination with different sheets. The porous sheet (mesh sheet) used in the present invention may have a part that does not have holes. Therefore, the breast mesh implant of the present invention may be composed of a combination of a sheet having porosity as a whole and a sheet having no holes in part or all.

  The material of the bag constituting the breast mesh implant of the present invention is not particularly limited as long as it is biocompatible, and whether it is biodegradable (absorbable) or non-biodegradable (nonabsorbable). Non-biodegradable (non-absorbable) materials include, for example, polyamide (eg, polyhexamethylene adipamide (nylon 66), polyhexamethylene sebamide (nylon 610), polycabramide (nylon 6), polydodecanamide (nylon 12). ), And polyhexaimethylene isophthalamide (nylon 61), copolymers and mixtures thereof), polyesters (eg polyethylene

Terephthalate, polybutyl terephthalate, polybutyl terephthalate, copolymers and mixtures thereof), fluoropolymers (eg polytetrafluoroethylene), and polyolefins (eg isotactic and syndiotactic polypropylene based mixtures) ) And the like. Polyester, polytetrafluoroethylene, foamed polytetrafluoroethylene, silicon, and polypropylene are preferable, and silicon and polypropylene are more preferable.

  Biodegradable (absorbable) materials include glycolide, lactide (L-, D-, and meso-form lactide and mixtures thereof, e-caprolactone, p-dioxanone, trimethylene carbonate, 1,4,4 -Conventionally known materials such as dioxeban-2-one, poly (alkylene oxalate) and a mixture of these polymers), and materials to be developed in the future can be exemplified without limitation. More specifically, various materials currently used for absorbable sutures. For example, cut gut (natural material), polyglycolic acid (synthetic material: for example, trade name Dexon, Keiseipondek, opepolix, etc.), poglactin (synthetic material: for example, trade name Bicuril, etc.) polyglyconate (synthetic material: for example , Brand name maxon, etc.) and polydioxanone (synthetic material: for example, brand name PDS).

  Further, in the breast mesh implant of the present invention, the porous sheet may be an upper layer only and a bag may be fixed below the upper layer. In other words, in the case of a mammary gland tissue defect that does not require a lower layer sheet, it may be possible to achieve a sufficient tree with only the upper layer porous sheet.

  If the bag is filled with a liquid such as physiological saline from the outside, the deficient part of the mammary tissue is filled with the swollen bag, and the remaining mammary tissue is brought into contact with moderate pressure, the healing process of the wound after the operation is performed. It is possible to prevent deformation due to scar contracture. For this purpose, as shown in the figure, a puncture part having a packing (4) made of silicon or rubber is provided so that liquid can be injected from the outside into a sheet having an upper porous layer, or the lower layer as shown in the figure. An injection port (6) can be connected to the bottom of the porous sheet to control injection from a site away from the surgical wound.

  The breast mesh implant of the present invention can be designed by appropriately adjusting the size of the porous sheet and bag depending on the size of the mammary tissue defect. It is also possible to cut the sheet during the operation and adjust its size.

  In the breast mesh implant of the present invention, a sheet having a lower porous layer is placed on a mammary gland exfoliation part in front of the pectoralis major muscle that has been excised by surgery after the resection is completed (if necessary, the upper porous layer is placed). The sheet is spread and attached to the subcutaneous mammary gland exfoliation part of the mammary gland tissue defect part, and is embedded.

  The breast mesh implant of the present invention is fixed to the mammary tissue defect part in close contact with the remaining mammary gland only in the bag part, while the skin having a porous upper layer is in close contact with the skin, so that the skin surface has a natural shape The natural shape can be imparted depending on the body position. Furthermore, if a mesh sheet is also attached to the lower surface of the bag, there is an advantage that the tissue defect portion can be more reliably fixed from the front and rear surfaces.

  As described above, the breast mesh implant of the present invention is newly inserted in the dorsal space of the pectoralis major muscle as in the conventional method for embedding in the defect of the mammary tissue after the breast-conserving operation. Compared to breast reconstruction, there is an advantage that the operation is easy and the resection and reconstruction can be performed simultaneously in a shorter time.

  A breast mesh implant composed of two layers of sheets does not necessarily take a parallel configuration as shown in FIG. Since there is a bag containing a liquid such as a raw meal between the meshes, it takes a form depending on the form of the remaining mammary gland tissue, so that it becomes a state close to the shape of a natural mammary gland as shown in the figure.

  The breast mesh implant of the present invention can be manufactured according to conventional methods known in the art. For example, the porous sheet as described above can be adjusted to a desired shape and size using a cutting blade, a hot knife, or an ultrasonic cutting device. Further, the structure including the bag can be formed by, for example, fixing the sheet and the bag by means of fusion (hot melt or the like), pressure-sensitive adhesion, adhesion, adhesion, or embossing.

The invention's effect

  Since the breast mesh implant of the present invention includes a bag, the breast mesh implant can be adapted relatively freely depending on the size of the bag and the amount of liquid injected, regardless of the size and shape of the mammary tissue defect. Moreover, since the upper mesh sheet is placed under the skin, it is difficult for post-operative depressions and protrusions of the breast skin to be obtained, and a natural shape and feel can be obtained. Furthermore, because the sheet is made up of two layers on the top and bottom of the bag, the bag can be fixed better. In addition, if a material with high biocompatibility (for example, polypropylene used in hernia surgery) is used as the material of the seat or bag, it can be safely and safely in vivo without any problems with allergies or carcinogenicity. It can be used by filling it. By using the mesh implant of the present invention, breast cancer and other mammary tumors can be reconstructed at the same time as reconstruction. Easier and shorter operation time is not required compared to conventional reconstruction methods. And the costs associated with it are greatly reduced, reducing the economic, mental and physical burden on the patient.

  Hereinafter, the contents of the present invention will be specifically described with reference to the following drawings. However, the present invention is not limited to these.

Example 1
As shown in the figure, the breast mesh implant of the present invention has mesh sheets attached to the upper and lower layers of the bag. A puncture part made of silicon or rubber is provided at the upper part of the adhering part with an injection needle from the outside, and the amount of injection can be adjusted to fill the defective part according to the size of the postoperative breast tissue Has a part. As shown in FIG. 2, a hood-like object (5) is attached under the puncture portion so that the bag is not torn by a needle punctured from the outside. In this way, the upper layer is spread on the skin under the breast and fixed to the upper edge of the mammary tissue, and the lower mesh sheet is spread on the front of the pectoralis major muscle at the lower edge of the mammary tissue defect, below the fascia and mammary tissue stump By attaching a liquid such as physiological saline into the bag and inflating it, the space of the tissue defect can be compensated regardless of the shape of the defect. In order to inject the liquid, an injection part can be installed in the upper sheet and an appropriate amount can be injected from outside the body, but an injection port can be installed in the attachment part of the bag of the lower sheet and used.

It is a perspective view which shows the one aspect | mode of the mesh implant of this invention. An upper and lower mesh sheets and a bag attached for the purpose of filling a tissue defect by injecting a liquid therebetween are shown. Shows a cross-sectional view of the breast mesh implant. An example of usage of the mesh sheet of the present invention will be shown. FIG. 3 is a view showing that the mesh sheet is mounted so as to be placed in a mammary gland tissue defect and the bag is inflated to maintain the normal mammary gland in the defect. The figure which has equipped the port for injection | pouring to the mesh implant of this invention is shown.

Explanation of symbols

1. 1. Upper mesh sheet 2. Lower mesh sheet 3. Bag for injecting liquids such as raw food 4. Puncture part made of silicon or rubber for injection from outside the body 5. Bag damage prevention hood with needle etc. when injecting from outside the body. Reservoir for infusion from outside the body attached to the mesh sheet

Claims (3)

It is a breast mesh implant formed from two sheets of porous material that are embedded and used between the pectoral muscles and the breast skin, and a bag placed between them. A breast mesh implant characterized in that a liquid such as raw food is injected into the bag from outside the body while adjusting the amount of injection according to the size of the tissue defect to replenish the tissue defect. The bag attached to the sheet is connected to an injection port or an injection port for the purpose of adjusting a liquid injection fee so that liquid can be injected between the two sheets from the outside. A breast mesh implant. For the purpose of replenishing the tissue defect that occurred after the mastectomy, the upper layer is sewn to the peeling surface under the breast, and in the case of an implant with two layers, the lower layer is the large breast at the bottom of the tissue defect. The purpose is to restore the shape of the breast on the operation side by sewing a bag placed between the two sheets into the front of the muscle and injecting a liquid such as saline to the volume corresponding to the volume of the tissue defect. The breast mesh implant according to claim 1, which is used in the above.

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