MESH SUPPORT DEVICE FOR A BREAST IMPLANT AND A METHOD FOR FIXATING A BREAST IMPLANT IN A MESH SUPPORT DEVICE
20220338971 · 2022-10-27
Assignee
Inventors
Cpc classification
A61F2/0063
HUMAN NECESSITIES
A61F2220/0033
HUMAN NECESSITIES
International classification
A61F2/00
HUMAN NECESSITIES
Abstract
The invention relates to a mesh support device (10) for supporting abreast implant (40), wherein the mesh support device (10) comprises a first panel (11) and a second panel (12), of which at least the second panel (12) is a mesh panel (12), which consists of a large number of individual meshes, and wherein the mesh support device (10) further comprises a first arm (31), which has a length Li and is arranged at a first side of the first panel (11), and a second arm (32), which has a length L2 and is arranged at a second side of the first panel (11), the second side being opposite to the first side, wherein each of the first and second arms (31, 32) is configured to be threaded through anyone of said large number of individual meshes and the lengths L.sub.1 and L.sub.2 are chosen such that 30 mm <L.sub.1 <210 mm and 30 mm <L.sub.2 <210 mm. The invention also relates to a method for fixating the breast implant (40) in the support device (10).
Claims
1. A mesh support device (10) for supporting a breast implant (40), wherein the mesh support device (10) comprises a first panel (11) and a second panel (12), of which panels at least the second panel (12) is a mesh panel (12), which consists of a large number of individual meshes, and wherein the mesh support device (10) further comprises a first arm (31), which has a length L.sub.1 and is arranged at a first side of the first panel (11), and a second arm (32), which has a length L.sub.2 and is arranged at a second side of the first panel (11), the second side being opposite to the first side, wherein each of the first and second arms (31, 32) is configured to be threaded through any one of said large number of individual meshes, and wherein 30 mm≤L.sub.1210 mm and 30 mm≤L.sub.2≤210mm.
2. The mesh support device (10) according to claim 1, wherein the first panel (11) is a mesh panel (11).
3. The mesh support device (10) according to claim 1, wherein 70mm≤L.sub.1 ≤180mm and 70mm≤L.sub.2≤180mm.
4. The mesh support device (10) according to claim 1, wherein 110mm≤L.sub.1≤150mm and 110mm≤L.sub.2≤150mm.
5. The mesh support device (10) according to claim 1, wherein the first and second arms (31, 32) have widths that are substantially larger than the dimensions of an individual mesh such that a friction locking is created once the arm (31, 32) has been threaded through an individual mesh.
6. The mesh support device (10) according to claim 1, wherein the first panel (11) is made from a first material and the second mesh panel (12) is made from a second material, the second material being different from the first material.
7. The mesh support device (10) according to claim 6, wherein the first and second materials are bio-degradable materials having different degradation times.
8. The mesh support device (10) according to claim 2, wherein the first mesh panel (11) and the second mesh panel (12) are cut out from the same piece of mesh material.
9. The mesh support device (10) according to claim 8, wherein also the first and second arms (31, 32) are cut out from the same piece of mesh material.
10. The mesh support device (10) according to claim 9, wherein the first arm (31) extends generally along the first side of the first mesh panel (11) and the second arm (32) extends generally along the second side of the first mesh panel (11).
11. The mesh support device (10) according to, claim 8 wherein the mesh material is a bio-degradable mesh material.
12. The mesh support device (10) according to claim 1, wherein the outer end of the first arm (31) and/or the outer end of the second arm (32) is pointed.
13. The mesh support device (10) according to claim 1, wherein the outer end of the first arm (31) and/or the outer end of the second arm (32) comprises stiffeners.
14. The mesh support device (10) according to claim 1 wherein the first mesh panel and the second mesh panel are divided or separated by a waist.
15. The mesh support device (10) according to claim 1 wherein the second mesh panel has a larger area and/or a larger width (W.sub.2) than the area and/or width (W.sub.1) of the first mesh panel.
16. A method for positioning and fixating a breast implant (40) in a mesh support device (10) comprising a first panel (11) and second panel (12), which are configured to be positioned opposite each other and of which at least the second panel (12) is a mesh panel (12), which consists of a large number of individual meshes, wherein the mesh support device (10) further comprises a first arm (31) arranged at a first side of the first panel (11) and a second arm (32) arranged at a second side of the first panel (11), the second side being opposite to the first side, which method comprises the steps of: determining a suitable position for the breast implant (40) between the first panel (11) and the second mesh panel (12); based on the determined suitable position, selecting a first one of said large number of individual meshes and threading the first arm (31) through this selected first individual mesh; and based on the determined suitable position, selecting a second one of said large number of individual meshes and threading the second arm (32) through this selected second individual mesh, wherein the selected first individual mesh and the selected second individual mesh are selected such that the breast implant (40) is positioned between the first arm (31) and the second arm (32).
Description
BRIEF DESCRIPTION OF THE DRAWINGS
[0024] The invention will be described below with reference to the appended drawings, wherein same or similar elements have been given the same reference numerals, and:
[0025]
[0026]
[0027]
[0028]
[0029]
[0030]
DETAILED DESCRIPTION OF PREFERRED EMBODIMENTS
[0031] In the figures, same, similar or corresponding elements have been given the same reference numerals.
[0032]
[0033] In one embodiment of the present invention the width of either the first mesh panel or the second mesh panel is larger than the other. In one embodiment the width of the first mesh panel is less than the width of the second mesh panel, W.sub.1<W.sub.2. In another embodiment of the present invention the area of either the first mesh panel or the second mesh panel is larger than the other. In one embodiment the area of the second mesh panel is larger than the area of the first mesh panel. This provides for a better enclosure of the breast implant and thereby better support.
[0034] Further, the first arm 31 has a length L.sub.1 and the second arm 32 has length L.sub.2. According to the invention, the arm lengths L.sub.1 and L.sub.2 are relatively long, and depend in practice on the size of the particular breast implant that the mesh support device 10 is intended to support. The size of the mesh support device 10, i.e. the areal size of the first panel 11 and the areal size of the second mesh panel 12, depends also on the size of the breast implant that is going to be used together with the support device 10, and here the size of the mesh support device 10 is characterized by the widths W.sub.1 and W.sub.2, respectively.
[0035] To achieve the special advantages with a mesh support device 10 according to the invention, the arms 31 and 32 are relatively long, but to not impair neither the user- friendliness nor the manufacturing efficiency should not be excessively long, and according to the present invention their lengths should be chosen such that 30mm≤L.sub.1 ≤210mm, and more preferably 70mm ≤L.sub.1 ≤180mm, and most preferably 110mm ≤L.sub.1 ≤150mm; and 30mm ≤L.sub.2 ≤210mm, and more preferably 70mm≤L.sub.2 ≤180mm, and most preferably 110mm ≤L.sub.2 ≤150mm. In this particular embodiment, there are two arms 31 and 32 provided on the first panel 11, but — as will be seen below — more arms, e.g. four or six arms, could be arranged. The first arm 31 and the second arm 32 have typically the same length (L.sub.1 =L.sub.2), but it is within the scope of the invention that the lengths L.sub.1 and L.sub.2 are different (L.sub.1≠L.sub.2) as long as L.sub.1 and L.sub.2 fulfill their respective length intervals as given above.
[0036] In
[0037] In the configuration shown in
[0038] Further, to keep the breast implant 40 securely in place, the first arm 31 and the second arm 32 are dimensioned such that a friction locking is created once one arm 31 or 32 has been threaded through an individual mesh. Thus, the widths of the first and second arms 31, 32 are chosen much larger than any dimension of an individual mesh. In practice, an arm 31 or 32 can be gently folded or rolled around its longitudinal axis before its outer end is threaded and forced through an individual mesh, which, when the arm 31 or 32 thereafter strives to resume its original shape, creates the friction locking that prevents the arm 31 or 32 from moving back out from the selected individual mesh once it has been threaded therethrough. To provide for a secure and reliable friction locking the first arm 31 can have width in the interval of 5 mm to 30 mm, and also the second arm 32 can have a width in the interval of 5 mm to 30 mm. However, the widths chosen for the first and second arms 31, 32 depend on the size and also shape of the individual meshes whose sizes and shapes are determined by the particular pattern the mesh is manufactured, e.g. the weaving pattern or knitting pattern which has been used during the manufacture of the second mesh panel 12 and, optionally, also the first mesh panel 11.
[0039] From
[0040]
[0041] Further, the first arm 31 has a length L.sub.1 and the second arm 32 has length L.sub.2. According to the invention, the arm lengths L.sub.1 and L.sub.2 are relatively long, and depend in practice on the size of the particular breast implant that the mesh support device 10 is intended to support. The size of the mesh support device 10, i.e. the areal size of the first panel 11 and the areal size of the second mesh panel 12, depends also on the size of the breast implant that is going to be used together with the support device 10, and here the size of the mesh support device 10 is characterized by widths W.sub.1 and W.sub.2, respectively.
[0042] To achieve the special advantages with a mesh support device 10 according to the invention, the arms 31 and 32 are relatively long, but to not impair neither the user- friendliness nor the manufacturing efficiency should not be excessively long, and according to the present invention their lengths should be chosen such that 30mm L.sub.1≤210mm, and more preferably 70mm ≤L.sub.1 ≤180mm, and most preferably 110mm≤L.sub.1≤150mm; and 30mm ≤L.sub.2 ≤210mm, and more preferably 70mm≤L.sub.2 ≤180mm, and most preferably 110mm ≤L.sub.2≤150mm. In this particular embodiment, there are two arms 31 and 32 provided on the first panel 11, but — as will be seen below — more arms, e.g. four or six arms, could be arranged. The first arm 31 and the second arm 32 have typically the same length (L.sub.1 =L.sub.2), but it is within the scope of the invention that the lengths L.sub.1and L.sub.2 are different (L.sub.1≠L.sub.2) as long as L.sub.1 and L.sub.2 fulfill their respective length intervals as given above.
[0043] In
[0044] In the configuration shown in
[0045] Further, to keep the breast implant 40 securely in place, the first arm 31, i.e. the width thereof, and the second arm 32, i.e. the width thereof, and are dimensioned such that a friction locking is created once one arm 31 or 32 has been threaded through an individual mesh. In practice, an arm 31 or 32 can be gently folded or rolled around its longitudinal axis before its outer end is threaded through an individual mesh, something which, when the arm 31 or 32 thereafter strives to resume its original shape, creates the friction locking that prevents the arm 31 or 32 from moving back out from the individual mesh once it has been threaded therethrough. To provide for a secure and reliable friction locking the first arm 31 can have width in the interval of 5 mm to 30 mm, and also the second arm 32 can have a width in the interval of 5 mm to 30 mm. However, the widths chosen for the first and second arms 31, 32 depend on the sizes and also shapes of the individual meshes that constitute the second mesh panel 12.
[0046] From
[0047] A comparison of
[0048]
[0049] Further, the first arm 31 has a length L.sub.1, the second arm 32 has length L.sub.2, the third arm 33 has a length L.sub.3 and the fourth arm 34 has a length L.sub.4. According to the invention, the arm lengths L.sub.1, L.sub.2, L.sub.3 and L.sub.4 are relatively long, and depend in practice on the size of the particular breast implant that the mesh support device 10 is intended to support. The size of the mesh support device 10, i.e. the size of the first panel 11 and the size of the second mesh panel 12, depends also on the size of the breast implant that is going to be used together with the support device 10, and here the size of the mesh support device 10 is characterized by widths W.sub.1 and W.sub.2, respectively.
[0050] To achieve the special advantages with a mesh support device 10 according to the invention, the arms 31, 32, 33 and 34 are relatively long, but to not impair neither the user-friendliness nor the manufacturing efficiency should not be excessively long, and according to the present invention their lengths should be chosen such that 30mm≤L.sub.1 ≤210 mm, and more preferably 70 mm≤L.sub.1≤180mm, and most preferably 110mm ≤L.sub.1 ≤150mm; and 30mm ≤L.sub.2 ≤210mm, and more preferably 70mm≤L.sub.2 ≤180mm, and most preferably 110mm ≤L.sub.2 ≤150mm; and 30mm ≤L.sub.3 ≤210mm, and more preferably 70≤mm L.sub.3 ≤180mm, and most preferably 110mm≤L.sub.3 ≤150mm; and 30mm ≤L.sub.4 ≤210mm, and more preferably 70mm ≤L.sub.4 ≤180mm, and most preferably 110mm ≤L.sub.4 ≤150mm In this particular embodiment, there are four arms 31, 32, 33 and 34 provided at the first panel 11, but other numbers of arms could have been arranged. The first arm 31 and the second arm 32 have typically the same length (L.sub.1 =L.sub.2), and the third arm 33 and the fourth arm 34 have typical the same length (L.sub.3 =L.sub.4), but it is within the scope of the invention that the all lengths are different (L.sub.1≠L.sub.2 ≠L.sub.3 ≠L.sub.4) as long as the arms fulfill their respective length intervals.
[0051] The third embodiment of a medical support device 10 shown in
[0052]
[0053] The mesh tabs 41, 42 can be made integral with the second mesh panel 12, i.e. the tabs 41, 42 and the second mesh panel 12 are cut out from the same piece of mesh material. As an alternative, it is, however, possible to arrange the mesh tabs 41, 42 as separate elements on the second mesh panel 12. The mesh tabs 41, 41 can then be attached, e.g. by sewing, stitching or gluing, on the second mesh panel 12. To provide individual meshes in mesh tabs 41, 42, which are arranged as separate elements, provide for the possibility to have one mesh material in the mesh tabs 41, 42 and another, different mesh material in the second mesh panel 12. The mesh material of a tab, and consequently the thread material that surrounds the individual meshes, can thereby, for example, be chosen to provide for a good strength and/or a good friction locking of the arms once threaded through an individual mesh, while the material selected for the second mesh panel provides for good flexibility and/or tissue integration. For all embodiments of the present invention, individual meshes can either be provided in a second mesh panel and are thereby located inside the general contour of the second mesh panel, or individual meshes can be provided in mesh tabs, which project out from the general contour of the second mesh panel and which either are integral with the second mesh panel, i.e. the mesh tabs and the second mesh panel are cut out from the same piece of mesh material, or which are arranged as separate elements and are attached to the second mesh panel by, for example, sewing, stitching or gluing. In the latter case, the mesh tabs and the second mesh panel can be made from the same type of mesh material or from different mesh materials.
[0054] As stated above, the present invention also relates to a method for positioning and fixating a breast implant in a mesh support device comprising a first panel and second panel, which are configured to be positioned opposite each other and of which at least the second panel is a mesh panel, which consists of a large number of individual meshes, wherein the mesh support device further comprises a first arm arranged at a first side of the first panel and a second arm arranged at a second side of the first panel, the second side being opposite to the first side, which method comprises the steps of: [0055] determining a suitable position for the breast implant between the first panel and the second mesh panel; [0056] based on the determined suitable position, selecting a first one of said large number of individual meshes and thread the first arm through this selected first individual mesh; and [0057] based on the determined suitable position, selecting a second one of said large number of individual meshes and threading the second arm through this selected second individual mesh, wherein the selected first individual mesh and the selected second individual mesh are selected such that the breast implant is positioned between the first arm and the second arm.
[0058] Each threading step can be preceded by same manipulation of the arm to be threaded. The arm can, for example, folded or rolled along its longitudinal extension, to thereby create a more solid and more pointed arm. To facilitate the threading operation, the arms can also be made more pointed, as was discussed in conjunction with
[0059] In
[0060]
[0061] Thus, for all embodiments presented herein, the dimension of an individual mesh is generally much smaller than the width of an arm that is configured to be threaded through the individual mesh. Typically, some manipulation is therefore required to initially force the arm through the selected individual mesh, and the arm can, for example, be gently folded or rolled along its longitudinal axis, to temporarily reduce its transverse extension, before the arms is threaded, i.e. pulled or pushed, through the individual mesh. To provide for a secure and reliable friction locking the first arm can have width in the interval of 5 mm to 30 mm, and also the second arm can have a width in the interval of 5 mm to 30 mm. However, the widths chosen for the first and second arms depend on the size and also shape of the individual meshes. The corresponding widths are applicable if more than two arms are arranged in or at a panel.
[0062] As has been mentioned above, the arms of a first panel can be arranged integral with the first panel, i.e. the arms and first mesh panel are cut out from the same piece of material, which can be a mesh material, or the arms can be arranged as separate elements which are attached to the first panel. In the latter case, the arms can be made from the same sort of material as the first panel, or the arms and the first panel can be made from different materials, such that one material is a mesh material or both materials are mesh materials. Similarly, for all embodiments presented herein, a first panel can be made from a first material, which can be a mesh material, and a second mesh panel can be made from a second material, which is different from the first material. In this case, the first panel and the second mesh panel are joined together, e.g. by sewing, at a position that will correspond to a midsection. If, for example, the first panel is intended to constitute the front panel, the first material can be a flexible material that adapts to the convex shape of the front side of a breast implant, while the second material is a material that promotes tissue integration at the backside of the breast implant. Obviously, the opposite applies if the second mesh panel is intended to constitute the front panel, while the first panel is intended to constitute the back panel.
[0063] However, as an alternative, which also applies for all embodiments presented herein, a first panel, which is a first mesh panel, and a second mesh panel can be made as an integral unit, which here means that the first mesh panel and the second mesh panel are arranged as one piece of mesh material, i.e. a front panel and a back panel are created by folding the piece of mesh material at a midsection or waist. This latter case, when the first mesh panel and the second mesh panel are made from the same piece of mesh material, provides for a very efficient and material-saving manufacturing, as is illustrated in
[0064]
[0065] A mesh panel of a mesh support device 10 can be made by means of any known knitting or weaving technique, and it is preferred that the mesh for the mesh panel is made by a technique that prevents unraveling of the mesh panel. One example of such a knitting technique is warp-knitting, which is a family of knitting methods in which the yarn zigzags along the length of the fabric, i.e. following adjacent columns of knitting rather than a single row. By using a manufacturing method that prevents, or at least reduces the risk of, unraveling, the mesh support device can be more reliable anchored (e.g. stitched, sewed, sutured or stapled) to the human breast tissue during and after implantation of a breast implant.
[0066] In a preferred embodiment, the mesh of a mesh support device 10 is made from a degradable material, and preferably from a bio-degradable material, which means that the material in question can be resorbed by the human body. By using a degradable material, which degrades inside the body, complications that are known to sometimes be associated with permanent mesh products can be avoided. Examples of materials in the fibers or yarns that constitute the mesh of the mesh support device 10 are (a) resorbable polymers with a relatively short degradation time, and non-limiting examples are polymers or copolymers made from the monomer glycolide in pure form, or in combination with paradioxanone, lactide, trimethylene carbonate or caprolactone, or polymers or copolymers made from the monomer paradioxanone in its pure form, or in combination with lactide, trimethylene carbonate or caprolactone; or (b) resorbable polymers with a relative long degradation time, and non-limiting examples are polylactide and polyurethanes, e.g. polyureaurethanes, polyesterurethanes and polycarbonateurethanes; or (c) any combinations thereof.
[0067] As indicated above, several materials can be combined in a single mesh support device according to the present invention, and a suitable mesh is commercially available under the tradename TIGR® Matrix Surgical Mesh and is sold by the company Novus Scientific. This mesh, which is described in U.S. Pat. Nos. 9,566,370, 8,083,755 and 8,016,841, comprises two different polymers having different degradation times, and it is believed that the resulting gradual degradation can promote tissue integration of a mesh support device made by this particular mesh. However, although synthetic and degradable materials are believed to be advantageous, a mesh support device according to the present invention can be made from permanent (non- degradable, non-resorbable) synthetic materials or even from biological materials, and any combination thereof
[0068] Although the present invention has been described with reference to specific embodiments, also shown in the appended drawings, it will be apparent to those skilled in the art that many variations and modifications can be done within the scope of the invention as described in the specification and defined with reference to the claims below.