JP4296405B2 - Breast mesh implant - Google Patents

Description

  The present invention relates to breast filling. More specifically, the present invention relates to a breast filling used by embedding a female breast defect in which a lesion tissue such as breast cancer or breast tumor is excised. The invention further relates to breast reconstruction using such breast filling.

  In many cases of breast cancer and breast tumor, surgical operation is performed to remove the lesion tissue of the breast. However, in recent years, there has been an increasing trend toward emphasizing quality of life (QOL) of patients, and the number of patients undergoing breast reconstruction after mastectomy is gradually increasing.

Traditionally, artificial breast filling has been used in such breast reconstruction techniques, either alone or in combination with its own skin and adipose tissue. As artificial breast filling that is widely used nowadays,
a) Silicon rubber sealed with silicon gel,
b) Stercon rubber sealed with sterile saline
c) A silicon gel is enclosed in an inner bag of silicon rubber, which is further contained in an outer bag of silicon rubber in which saline is enclosed, and d) solidified silicon.

  However, in a), there is a risk that silicon gel leaks through silicon rubber due to leaching or silicon rubber ruptures and flows out into the body, resulting in adverse effects on the human body such as allergies, cancer, and kidney damage. Has been pointed out. Also in b), it is pointed out that there is a risk of the physiological saline flowing out due to the rupture of the silicone rubber. Even though the saline outflow does not adversely affect the human body, the volume reduction of the breast filling can damage the shape of the breast and require further surgery. Although c) was developed for the purpose of preventing the silicone gel from flowing out into the body and preventing adverse effects on the human body, it actually includes all of the drawbacks of a) and b). Moreover, although the problem of rupture was solved by d), the problem of carcinogenicity and allergy caused by the contact of silicon itself with living tissue still remains. In this way, conventional artificial breast fillers cannot be directly embedded in the affected area because they are not only adversely affected by rupture but also have adverse effects such as allergies and carcinogenesis only by contacting with the material. Separately, a method of creating a filling space on the back of the pectoralis major muscle and embedding it is adopted. Such breast reconstruction imposes a physical and mental burden on the patient and involves significant time and cost problems.

  By the way, in the past, breast cancer treatment was mainly performed by total mastectomy in which the entire breast was removed and the regional lymph nodes were extensively cleaned. However, due to medical progress in breast cancer treatment and increasing QOL awareness, Breast-conserving surgery has been widely used, in which the lesion tissue is partially removed and radiation therapy is performed after surgery. In breast-conserving surgery, one-half to three-fourths of the breast remains, so there is no need for a breast filling that would normally be used to fill almost the entire breast. Usually, the surrounding tissue is sutured to suture the breast. At present, the shape is adjusted.

  However, although the excision is 1/4 to 1/2, the affected part is inevitably depressed and deformed in order to excise the breast tissue, and the shape and size of the breast are imbalanced between the operation side and the health side. For this reason, reconstruction has been attempted by transplanting muscles of the back and abdomen and subcutaneous fat into the defect, but a new wound is created by collecting the tissue and is painful. From the viewpoint of QOL, This is not necessarily the preferred method.

In addition, patent documents 1-12 can be mentioned as literature which disclosed the prior art regarding a breast filling.
JP-A-57-136447 JP-A-60-502237 JP 62-5342 A JP-A-62-231658 JP 63-38445 A Japanese Unexamined Patent Publication No. 1-190352 Japanese Unexamined Patent Publication No. 3-140155 Japanese Patent Laid-Open No. 4-261652 JP-A-5-505541 Japanese Utility Model Publication No. 5-62220 Japanese National Patent Publication No. 11-503652 Special table 2001-519203

  The present invention provides an implantable prosthetic breast filling that is used to reconstruct a breast by correcting depressions and deformations caused by excising breast tissue in the treatment of breast cancer or breast tumors. Objective. More specifically, an object of the present invention is to provide a breast filling that is used by being embedded in a tissue defect between the great pectoral muscle and breast skin caused by mastectomy. In particular, it is an object of the present invention to provide a breast filling that is used to fill defects in partial resection of a breast including a tumor in breast-conserving surgery.

  The present inventor has been diligently studied to solve the above-mentioned problems. As a result, the breast filling made of a porous sheet (mesh sheet) having the following specific configuration (hereinafter referred to as the breast filling of the present invention is referred to as “ It has been found that the above-mentioned 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 4 below:
Item 1. A breast mesh implant formed from a porous sheet, which is used by being embedded between the pectoral muscle and the breast skin, and has a recess (recessed hole, recessed recess) and a base of the recess A sheet portion (first sheet portion) extending from the peripheral edge of the edge, and a sheet portion (second sheet portion) extending in the direction of 360 degrees from the distal end surface of the concave portion, and based on at least the concave portion A breast mesh implant characterized by having elasticity.
Item 2. Part or all of the sheet part (first sheet part) extended from the peripheral edge of the base end of the concave part is a sheet part (second sheet part) extended in the 360 degree direction from the distal end surface of the concave part. Item 2. The breast mesh implant according to Item 1, which is provided so as to cover.
Item 3. The length of the sheet portion (second sheet portion) extending in the 360-degree direction from the distal end surface of the concave portion is a sheet portion (first sheet) extending from the base end periphery of the concave portion. The length of the former second sheet part in the Z-axis direction is shorter than the length of the latter first sheet part in the Z-axis direction, and is shorter than the length in the Z-axis direction of the latter first sheet part. Breast mesh implant.
Item 4. Item 4. The breast mesh implant according to any one of Items 1 to 3, wherein the concave portion has a substantially cylindrical shape, a substantially truncated cone shape, or an incomplete spherical shape.

Further, the present invention is a breast mesh implant listed in the following item 5:
Item 5. A breast mesh implant formed from a sheet having at least two perforations, which is used by being embedded between the pectoral muscle and the breast skin, and one sheet (first sheet) is a concave cavity (a recessed hole). , A concave recess) portion, and the front end surface of the recess is in contact with the surface of the other sheet (second sheet). A breast mesh implant characterized by having an elastic force based on

Such breast mesh implants include the following embodiments:
Item 5-1. Item 6. The breast mesh implant according to Item 5, wherein a part or all of the sheet portion of the sheet having the concave portion (first sheet) is covered with the sheet portion of the other sheet (second sheet).
Item 5-2. The length in the X-axis direction of the sheet having the recessed portion (first sheet) is longer than the length in the X-axis direction of the other sheet (second sheet), and the length of the former first sheet in the Z-axis direction is longer Item 5. The breast mesh implant according to Item 5, wherein the latter second sheet is shorter than the length in the Z-axis direction.
Item 5-3. Item 5. The breast mesh implant according to any one of Items 5 to 5-2, wherein the concave portion has a substantially cylindrical shape, a substantially truncated cone shape, or an incomplete spherical shape.
Item 5-4. Item 5, Item 5-1, which is an aspect of the breast mesh implant described in each of Item 1, Item 2, Item 3, and Item 4. Item 5-2 and Item 5-3 are breast mesh implants.

  These breast mesh implants described in each of the above items 1 to 5-4 are breast fillings that are used by being embedded in a defect caused by partial breast resection in breast-conserving surgery.

  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.

  The shape of the porous sheet (mesh sheet) is not particularly limited as long as it is porous. Specific examples include a porous film, and a net (mesh) made of monofilament or multifilament, woven fabric, or knitted fabric. The mesh sheet is preferably made from a filament in terms of stretchability, and more preferably a mesh mesh sheet (knitted mesh sheet) in terms of elasticity. The stitch structure is not particularly limited, but it is preferable to have a stitch structure having stretchability with respect to the sheet parallel plane and elasticity with respect to the sheet vertical direction. Examples of such a stitch structure include, but are not limited to, weft stitches such as flat knitting, rubber knitting, and pearl knitting, and warp stitches such as tricot knitting, Raschel knitting, and Milanese knitting. A warp stitch structure is preferable 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, cotton, linen, silk, polyamide [eg, polyhexamethylene adipamide [nylon 66], polyhexamethylene sebacamide [nylon 610], polycapramide [ Nylon 6], polydodecanamide [nylon 12], and polyhexaimethylene isophthalamide [nylon 61], copolymers and mixtures thereof], polyesters (eg, polyethylene terephthalate, polybutyl terephthalate, copolymers and mixtures thereof) ], Fluoropolymers [eg, polytetrafluoroethylene], and polyolefins [eg, polypropylene including isotactic and syndiotactic polypropylene, and isotactic and syndiotactic polypropylene mixed with polyethylene. It can be exemplified mixtures] and the like as a main component a. 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), ε-caprolactone, p-dioxanone, trimethylene carbonate, 1,4 -Conventionally known materials such as dioxepan-2-one, poly (alkylene oxalate) and a mixture of these polymers, and materials developed in the future can be exemplified without any limitation. More specifically, various materials currently used for absorbable sutures, such as cut gut (natural materials), polyglycolic acid (synthetic materials: for example, trade names such as Dexon, Keisei Bondec, and Opepolix), Examples thereof include polyglactin (synthetic material: for example, trade name Bicyclyl), polyglyconate (synthetic material: for example, trade name Maxon), and polydioxanone (synthetic material: for example, trade name PDS).

  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 of 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.

  Further, the breast mesh implant of the present invention is formed from such a porous sheet, and extends from (1) a concave portion (a concave hole or a concave portion), and (2) a proximal end periphery of the concave portion. The second feature is that it comprises a sheet part (first sheet part) that has been taken out, and (3) a sheet part (second sheet part) that has been extended and extended from the distal end surface of the concave part in a 360-degree direction. To do.

  The concave portion of (1) plays a role of imparting elastic force and bulge to the breast mesh implant for the purpose of reforming a breast having natural elasticity and bulge. Therefore, although the shape of the concave portion is not particularly limited as long as this object is achieved, for example, a substantially cylindrical shape, a substantially truncated cone shape, an incomplete spherical shape, and the like can be arbitrarily given. Here, an incomplete sphere is a part of a sphere (for example, 1/4, 1/2 or 3/4 of the sphere) lacking, for example, 3/4 sphere, hemisphere, or ¼. It means an incomplete sphere such as a sphere. From the viewpoint of restoring a breast having natural elasticity and swelling, and the ease of manufacturing, the shape of the concave portion can be preferably a substantially cylindrical shape or a substantially truncated cone shape.

  Further, the size of the concave portion is not particularly limited. The size of the concave portion is the same as that of the breast mesh implant of the present invention having the concave portion and a sheet portion extending and extending in the direction of 360 ° C. from the proximal end and the distal end surface of the concave portion. It can be appropriately prepared and designed so as to have a size suitable for implantation and placement in a defect (breast removal site) caused by tissue removal. The concave portion is formed of a porous sheet, and preferably, the concave portion is a space region, so that the concave portion can be relatively flexibly adapted to various sizes and shapes of the affected portion. be able to.

  Although there is no limitation, as an example of the size of the concave portion, when the shape of the hole or the concave portion of the concave portion is a cylindrical shape (cylindrical concave portion) like the breast mesh implant shown in FIG. The diameter of the cylindrical recess is about 5 to 60 mm, about 10 to 50 mm, about 20 to 40 mm, or about 35 to 40 mm; the depth of the cylindrical recess (column height) is about 5 to 60 mm , About 10 to 50 mm, about 20 to 40 mm, or about 30 to 40 mm. In addition, also when a concave part has another shape, it can have a magnitude | size according to this.

  FIG. 1 shows a breast mesh implant having a cylindrical recess (columnar recess) as one embodiment of the present invention. (A) is the perspective view, (b) is a cross-sectional view of the breast mesh implant that is cut in the longitudinal direction, (c) is a top view, and (d) is a bottom view. Hereinafter, the form of the breast mesh implant of this invention is demonstrated based on FIG.

The first sheet portion of (2) of the breast mesh implant of the present invention has a proximal end periphery 2 of the concave portion, in other words, a proximal end (hole or concave mouth) that forms a hole or a hollow of the concave portion 1. It is the sheet | seat part 3 extended and formed from the whole periphery (periphery). The second sheet portion (3) is a sheet portion 5 that extends from the distal end surface 4 of the concave portion 1 in the direction of 360 ° centrifugal.

  In FIG. 1, the shape of the breast mesh implant of the present invention is described so that the first sheet portion and the second sheet portion are in parallel with each other, but this is for the sake of easy understanding. Actually, when the breast mesh implant of the present invention is disposed on, for example, an arbitrary flat substrate with the first sheet portion facing down and the second sheet portion facing upward, the peripheral edge of the second sheet portion is caused by its own weight. In general, it hangs down to the first sheet portion side (see, for example, FIG. 3A).

The breast mesh implant of the present invention having at least these two sheet portions is such that the first sheet portion faces the inside of the chest facing the pectoralis major muscle and the second sheet portion faces the breast skin. Located in the excision defect. At this time, the first sheet portion is suitably used as a base sheet for stably arranging the breast mesh implant on the pectoral muscle surface side of the mastectomy defect. In addition, the first sheet portion is effectively used as a seam allowance for fixing the breast mesh implant to the mastectomy defect. On the other hand, when the second sheet portion is arranged as described above, the second sheet portion hangs down to the first sheet portion side. As a result, the breast mesh implant of the present invention has a dome-shaped or hemispherical curved shape with the concave portion 1 inside, and as a result, imparts elasticity and swelling to the breast. Can do.

  The difference in size and shape between the first sheet portion and the second sheet portion is not particularly limited. In addition, here, when referring to the size and shape of the first sheet portion, the size and shape of the first sheet portion are determined from the outer peripheral edge of the sheet portion, and the deletion portion due to the concave portion is not considered.

  For example, when the second sheet portion is larger than the first sheet portion and arranged as described above (arranged with the first sheet portion down and the second sheet portion up), the second sheet portion causes the first sheet portion to All may be covered, or only a part of the first sheet portion may be covered by the second sheet portion.

  These sheet parts (at least one of the first sheet part and the second sheet part) are effectively used as a seam margin for placing a breast mesh implant in a mastectomy defect and fixing it to the placement part. Is done. Thereby, the breast mesh implant of the present invention can be more stably fixed to the mastectomy defect.

  The breast mesh implant of the present invention can have a size or shape such that the first sheet portion and the second sheet portion protrude from the other sheet portion. As specific embodiments of such a sheet portion, for example, as shown in FIGS. 1C and 1D, the length in the X-axis direction and the length in the Z-axis direction for the first sheet portion and the second sheet portion, respectively. , The length of the first sheet portion in the X-axis direction is longer than the length of the second sheet portion in the X-axis direction, and the length of the first sheet portion in the Z-axis direction is Z of the second sheet portion. An aspect that is shorter than the length in the axial direction can be exemplified. Here, the length of the sheet portion in the X-axis direction is the distance between two points (from one point) intersecting the outer edge of the sheet portion when a line is drawn in the X-axis direction so as to pass through the center of the sheet portion. This means the distance (length) to the other point. The length in the Z-axis direction intersects with the outer edge of the sheet part when a line is drawn in the Z-axis direction so as to pass through the center of the sheet part. It means the distance between two points (distance (length) from one point to the other point). In addition, in FIG. 1, although the 2nd sheet | seat part has a substantially circular shape and the 1st sheet | seat part has an elliptical shape and each has a different shape, regardless of this, both have the same shape It may have. For example, in the case where a sheet part having a different length in the X-axis direction and a length in the Z-axis direction, such as an ellipse or a rectangle, is used, the first sheet part and the second sheet part may have the same shape. By arranging so that both sheets do not overlap, it can be prepared in the above-described embodiment having portions protruding from each other.

  The shape and size of each sheet part are not particularly limited as long as they meet the object of the present invention. The shape is preferably circular or elliptical. The size can be about 20 to 150 mm, about 30 to 100 mm, or about 50 to 90 mm.

  The breast mesh implant of the present invention can be produced by integral molding using a porous sheet so as to include each of the components (1) to (3). It can also be created from other sheets.

Breast mesh implant, when formed from at least two sheets having a porous, for example, as shown in FIG. 2, the breast mesh implant crypts unit 1 in a part as one sheet (first sheet 6) Using a sheet having a (recessed hole, recessed recess), the outer surface of the front surface of the recess is attached to the surface of the other sheet (second sheet 7 ) in a state where it is applied (attachment) Can be formed. In this state, both sheets are laminated with the concave portion 1 of the first sheet 6 (from another point of view, it can also be said to be a “convex portion” formed by the concave portion of the first sheet). Thus, the breast mesh implant thus formed has an elastic force based on at least the concave portion 1 (convex portion).

The concave portion 1 formed by the first sheet 6 of the breast mesh implant corresponds to the concave portion 1 shown in FIG. 1 (b), and the portion other than the concave portion 1 of the first sheet 6. That is, the sheet portion extending in the direction of 360 degrees from the periphery of the concave portion 1 (corresponding to the base end periphery 2 in FIG. 1B) corresponds to the first sheet portion 3 in FIG. Further, the second sheet 7 corresponds to the sheet formed from the second sheet portion 5 and the front end surface 4 of the concave portion of FIG. Note that the contact area between the second sheet 7 and the concave surface of the first sheet 6 corresponds to the concave surface 4 of FIG.

It should be noted that the breast mesh implant created from the two sheets is arranged with the first sheet 6 as a base sheet and the second sheet 7 up (actually, the first sheet 6 is a mastectomy defect portion). 2), the second sheet 6 covers the convex part formed by the concave part 1 of the first sheet. As a result, the breast mesh implant has a dome-shaped or hemispherical curved shape with the concave portion 1 (convex portion) inside, and as a result, the breast is elastic and bulges. Can be granted.

  The breast mesh implant of the present invention is used by being embedded between the greater pectoral muscle and the breast skin, specifically, in a tissue defect part (breast defect part) in which a lesion has been excised by mastectomy. In this respect, the breast mesh implant of the present invention is different from the conventional artificial breast filling used by being implanted in the back of the pectoralis major muscle. The reason why the conventional breast filling is used by embedding it in the back of the pectoralis major muscle is that the conventional breast filling is filled with silicone gel or physiological saline in the bag, and the contents may flow out due to breakage. This is because the pectoralis must be protected by the large pectoral muscle, and the weight must be supported by the pectoral pectoral muscle. On the other hand, the breast mesh implant of the present invention is composed of a porous sheet (mesh sheet) as described above, and is not a filling such as silicon gel or physiological saline, but a concave formed by the porous sheet. Since the shape of the breast and the elasticity are reconstructed by the pits (convex portion when viewed from another angle), it is lightweight and does not cause the problem of the outflow of the filling contents due to breakage. For this reason, the breast mesh implant of the present invention can be used by directly embedding and filling a breast defect portion produced by excision of a cancer or a mammary tumor.

  Furthermore, the breast mesh implant of the present invention is made of a porous sheet material and has a plurality of spatial regions therein. As a result, when the breast mesh implant of the present invention is embedded in a living body, the body fluid can easily penetrate into the inside and has high biocompatibility, and can promote tissue regeneration using it as a scaffold. And can be integrated.

Radiation therapy is usually performed after breast-conserving surgery. However, the conventional artificial breast filling made of silicon or the like is feared to be deteriorated by radiation irradiation and to be carcinogenic. For this reason, in the breast preservation method, it is common to insert a filling material after radiation therapy. On the other hand, as described above, the breast mesh implant of the present invention can be formed using a material such as polypropylene, which is known to have no material change due to irradiation. For this reason, the breast mesh implant of the present invention formed from such a material can simultaneously perform mastectomy and breast reconstruction without examining the effects of radiation irradiation in postoperative radiation therapy.

  As described above, the breast mesh implant of the present invention can be embedded and filled directly into the breast defect portion after the mastectomy, so that the conventional breast used by being embedded in a space formed by newly incising the back of the pectoralis major muscle. Compared to the filling, it is easy to perform and can be performed simultaneously with mastectomy and breast reconstruction, and has the advantage of not causing physical and mental pain to the patient.

  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 prepared into a desired shape and size using a cutting blade, a hot knife, or an ultrasonic cutting device. Further, the three-dimensional structure including the concave portion of the breast mesh implant can be formed, for example, by forming a sheet on a heating device and then cooling to fix the shape. When polypropylene is used as the sheet material, the sheet is heated on a heating device in the temperature range of about 80 to 160 ° C., preferably about 120 ° F. for a suitable time (preferably 10 seconds or more, 30 seconds). Within a minute), it can be thermoformed. In addition, it is necessary to perform this thermoforming process so that a sheet | seat material may not be deformed or a structure will deteriorate. In general, a sheet material made of polypropylene is a male type that joins at a speed in the range of about 2 centimeters / minute to about 25 centimeters / minute, preferably at a speed in the range of about 5 centimeters / minute to about 7.5 centimeters / minute, and Compressed between female forming tools. Furthermore, the sheet material made of polypropylene can be usually formed into a desired shape by heating in the range of 2 to 5 minutes, and then the shape can be fixed by cooling at a temperature below room temperature. In particular, it is desirable to cool in a range of about 2 to 5 minutes at a temperature of about 15 ° C. or less.

Further, the structure portion formed of the sheet material formed in this manner is an appropriate attachment means, for example, any means such as stitching, fusion (hot melt, etc.), pressure-sensitive adhesion, adhesion, adhesion, or embossing, Can be joined to other structural parts. For example, the concave portion 1 formed using the above-described method includes the first sheet portion 3 via the proximal peripheral edge 2 of the concave portion and the outer peripheral edge of the concave distal end surface 4 . It can be joined to the two sheet portions 5 . In addition, when the breast mesh implant is formed from two sheets (a first sheet and a second sheet) having porosity, the first sheet having the concave portion 1 formed by using, for example, the heating method described above. 6 can be joined to the second sheet 7 in a state in which the tip surface of the concave portion is applied.

  The breast mesh implant of the present invention is formed from a porous sheet having high biocompatibility and made of a non-biodegradable or biodegradable material, and has a spatial region inside including a concave portion. . For this reason, it becomes possible to adapt to the size and shape of the excision defect part relatively freely. Moreover, since the breast mesh implant of the present invention has a bulge having a desired elastic force, particularly based on the concave portion, correction correction is performed on the breast having a shape and feel (elasticity) close to natural at the time of breast reconstruction. A breast filling that can.

The present invention also relates to breast reconstruction using the breast mesh implant of the present invention. The breast reconstruction can be basically performed by a method including the following four steps:
(A) From among the breast mesh implants of the present invention, a breast mesh implant suitable for the size and shape of the resected breast tissue (for example, a breast mesh implant having substantially the same size and shape as the resected breast tissue). Process to select,
(B) inserting the breast mesh implant from a skin incision created by the mastectomy into a defect between the pectoralis major muscle and the breast skin produced by the mastectomy;
(C) The inserted breast mesh implant is sutured to the surrounding mammary gland tissue or adipose tissue as necessary, and fixed to the defect affected area, and (d) the skin incision is sutured closed to embed the breast mesh implant. Process.

  According to the breast mesh implant of the present invention, the reconstruction operation can be performed simultaneously with the excision operation of the breast lesion such as a breast cancer and a breast tumor, so that the time required for the reconstruction can be shortened and the cost for the reconstruction can be greatly reduced. Can do. Moreover, there is no worry about side effects such as carcinogenesis and allergies. Furthermore, it is not necessary to form a separate filling space on the back of the pectoralis major muscle, and as described above, the resection of the lesion and the reconstruction of the breast are completed in one operation, thus reducing the mental and physical burden on the patient. Can do.

  Since the breast mesh implant of the present invention includes a concave portion formed so as to have elasticity, it can be relatively freely adapted to the size and shape of the excision defect. In addition, the breast mesh implant of the present invention is provided with an elastic force, particularly based on the concave portion thereof, so that the depression and dent appearing on the skin during breast reconstruction are improved, and the shape and feel close to natural breast (elasticity) ) Can be corrected and repaired to the breast. Furthermore, the breast mesh implant of the present invention prepared using a sheet of material having high biocompatibility (for example, made of polypropylene) as a porous sheet can be safely filled in the living body without problems such as allergies and carcinogenicity. Can be used.

  According to the breast mesh implant of the present invention, a reconstruction operation can be performed simultaneously with a breast lesion excision operation such as a breast cancer and a breast tumor, so that the time required for the reconstruction can be shortened and the cost for the reconstruction can be greatly reduced. it can. In addition, it is not necessary to separately form a filling space on the back of the pectoralis major muscle, and as described above, the lesion excision and breast reconstruction are completed in one operation, so that the mental, physical and economic burdens given to the patient. Can be reduced.

  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
FIG. 1 shows an embodiment of the breast mesh implant of the present invention. In use, the breast mesh implant is disposed at the resection defect portion of the breast so that the second sheet portion 5 faces the breast skin so that the first sheet portion 3 faces the greater pectoral muscle. Fig. (A) is a perspective view of a breast mesh implant, Fig. (B) is a cross-sectional view of the breast mesh implant cut in a longitudinal direction, Fig. (C) is a top view of the breast mesh implant as viewed from above, and Fig. (D). Shows a bottom view of the breast mesh implant as seen from below.

As shown in the figure (b), the breast mesh implant has a concave portion (concave hole) 1 formed from a porous sheet. The first sheet portion 3 projects from the base edge 2 in the 360 ° direction, while the second sheet portion 5 projects from the distal end surface 4 of the concave portion in the 360 ° direction. is doing. For this reason, as shown in FIG. 1A, the breast mesh implant has a configuration in which the first sheet portion 3 and the second sheet portion 5 are laminated via the concave portion 1 . In addition, although what has a columnar shape is illustrated as the concave part 1 in FIG. 1, it is not limited to this, It prepares in arbitrary shapes, such as an elliptical column shape, an incomplete spherical shape, and a substantially truncated cone shape. can do. Further, in FIG. 1, the second sheet portion 5, there is a parallel with the first sheet portion 3 through the crypts portion 1, actually, as shown in (a) of FIG. 3, the second sheet portion 5 Has a dome shape curved so as to cover the first sheet portion 3 together with the front end surface 4 of the concave portion due to its own weight. This allows the breast mesh implant to mimic the bulge of the breast. In addition, the elasticity of the breast can be imitated by the recessed portion 1 wrapped inside.

In FIG. 1, the first sheet portion 3 has an oval shape, the second sheet portion 5 has a circular shape, and the length in each X-axis direction (first sheet portion: X1, second sheet portion: X2) is “X1. > X2 ”, the first sheet portion 3 is longer, and the length in each Z-axis direction (first sheet portion: Z1, second sheet portion: Z2) is“ Z1 <Z2 ”, and the second sheet portion 5 is longer. As an example, X1 is 60 to 100 mm, preferably about 80 mm; X2 is 50 to 90 mm, preferably about 70 mm; Z1 is 40 to 80 mm, preferably about 60 mm; Z2 is about 60 to 100 mm, preferably about 80 mm Can be mentioned. Moreover, 20-40 mm as a length of Y reflecting the depth of the recessed part 1 can be illustrated, Preferably it is 30-40 mm.

  The breast mesh implant can be composed of a polypropylene mesh sheet, preferably a polypropylene mesh sheet, as a porous sheet in any structural part.

The breast mesh implant is used by being embedded in a mastectomy defect portion with the first sheet portion 3 side facing the inner side of the chest facing the greater pectoral muscle. In addition, when the size of one sheet | seat part has an ellipse or a rectangle like the said breast mesh implant, it also has the advantage that it is easy to insert in an affected part (mastectomy defect part).

Example 2
In addition, the breast mesh implant of the present invention may have a cross section shown in (b ′) of FIG. 2 instead of (b) of FIG. That is, the breast mesh implant is shown in a perspective view (FIG. 1 (a)), a cross-sectional view (FIG. 2 (b ')), a top view (FIG. 1 (c)), and a bottom view (FIG. 1 (d)). It has a form.

As shown in FIG. 2 (b ′), the breast mesh implant is formed from two sheets (a first sheet 6 and a second sheet 7 ) having porosity. The first sheet 6 has an oval shape (X-axis length X1 (about 80 mm)> Z-axis length Z1 (about 60 mm)), and has a concave portion 1 (a convex portion if the view is changed) in the substantially central region. And a depth of about 30-40 mm). The distal end surface 4 of the concave portion is on the substantially central region surface of the second sheet 7 whose outer side has a circular shape (X-axis length X2 (about 70 mm) = Z-axis length Z2 (about 80 mm)). I'm wearing it. The shape of the recessed portion 1 is not limited to the columnar shape shown in FIG. 1, and can be adjusted to an arbitrary shape such as an elliptical columnar shape, an incomplete spherical shape, or a substantially truncated cone shape. In addition, as in Example 1, FIG. 1 shows that the second sheet 7 is in a state parallel to the first sheet 6 with the concave portion 1 in between. As shown in a), the second sheet 7 has a dome shape that is curved so as to cover the sheet portion of the first sheet 6 in a state where the peripheral edge faces downward due to its own weight and the recessed portion 1 is wrapped inside. . This allows the breast mesh implant to mimic the bulge of the breast. In addition, the elasticity of the breast can be imitated by the recessed portion 1 wrapped inside.

The breast mesh implant is used by being embedded in a mastectomy defect with the first sheet 6 side facing the chest side facing the greater pectoral muscle. In addition, when the size of one sheet | seat part has an ellipse or a rectangle like the said breast mesh implant, it also has the advantage that it is easy to insert in an affected part (mastectomy defect part).

  The preferred embodiments of the present invention have been described with reference to the drawings as examples. However, the breast mesh implant of the present invention is not limited to these drawings, and modifications and corrections that can be normally made by those skilled in the art are described below. It is included in the present invention.

  Since the breast mesh implant of the present invention has an elastic restoring force, it improves the depressions and depressions that appear on the skin during breast reconstruction, and corrects and repairs the breast with a shape and feel (elasticity) close to that of a natural breast. can do. According to the breast mesh implant of the present invention, a reconstruction operation can be performed simultaneously with a breast lesion excision operation such as a breast cancer and a breast tumor, so that the time required for the reconstruction can be shortened and the cost for the reconstruction can be greatly reduced. it can. In addition, it is not necessary to separately form a filling space on the back of the pectoralis major muscle, and as described above, the lesion excision and breast reconstruction are completed in one operation, so that the mental, physical and economic burdens given to the patient. Can be reduced.

It is a figure which shows the one aspect | mode of the breast mesh implant of this invention. (A) is the perspective view, (b) is a cross-sectional view of the breast mesh implant cut in the longitudinal direction, (c) is a top view thereof, and (d) is a bottom view thereof. It is a figure which shows the cross-sectional view of the one aspect | mode of the breast mesh implant of this invention cut | disconnected in the vertical direction. It is a figure which shows the one aspect | mode of the breast mesh implant of this invention. (A) is a perspective view when the first sheet 6 is disposed below according to the usage mode, (b) is a perspective view of the implant with the back side up by inverting the breast mesh implant shown in (a). It is.

Explanation of symbols

1. Concave part 2. 2. Proximal peripheral edge of the recess First sheet part 4. 4. End surface of the recess Second sheet portion 6. First sheet 7. 2nd sheet

Claims (4)

A breast mesh implant formed only from a porous biocompatible mesh sheet, which is used by being embedded between the pectoral muscle and the breast skin, and one cylindrical concave portion having a spatial region therein , A first sheet portion extending from the periphery of the hole of the concave portion or the mouth of the concave portion, and a second sheet portion extending in a 360-degree direction from the convex tip surface of the concave portion, and at least the concave portion A breast mesh implant characterized by having an elastic force based on the part. The second sheet portion extending in the direction of 360 degrees from the convex tip surface of the concave portion covers a part or all of the first sheet portion extending from the periphery of the hole of the concave portion or the mouth of the recess. The breast mesh implant according to claim 1, which is provided as described above. The length of the X-axis direction of the second sheet portion extending from the convex distal end surface 360 degree direction of the crypts portion, the first sheet portion extending from the peripheral edge of the hole or recess in the mouth of the crypts portion The breast according to claim 1 or 2, wherein the length of the former second sheet portion in the Z-axis direction is shorter than the length of the latter first sheet portion in the Z-axis direction. Mesh implant. The breast mesh implant according to any one of claims 1 to 3 , wherein the breast mesh implant is used by being embedded in a defect caused by partial breast resection in breast-conserving surgery.

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