阅读说明：本技术 ***植入物中的非加压空气袋 (Non-pressurized air bag in breast implant ) 是由 A.戈瓦里 Y.阿尔加维 于 2018-11-14 设计创作，主要内容包括：本发明公开了一种可植入装置,所述可植入装置包括：密封的柔性第一壳体,所述密封的柔性第一壳体被构造用于植入人类受试者的乳房内；弹性填充材料,所述弹性填充材料容纳在所述密封的柔性第一壳体内；密封的柔性第二壳体,所述密封的柔性第二壳体设置在位于所述密封的柔性第一壳体内部的所述弹性填充材料内；以及一定体积的气体,所述一定体积的气体容纳在所述密封的柔性第二壳体内,使得所述气体的体积小于当所述装置经受一个大气压的外部压力时在所述密封的柔性第二壳体内引起非零应变所需的阈值充气体积。(The present invention discloses an implantable device comprising: a sealed flexible first shell configured for implantation within a breast of a human subject; an elastomeric filler material contained within the sealed flexible first housing; a sealed flexible second housing disposed within the resilient filler material inside the sealed flexible first housing; and a volume of gas contained within the sealed flexible second housing such that the volume of gas is less than a threshold inflation volume required to induce a non-zero strain within the sealed flexible second housing when the device is subjected to an external pressure of one atmosphere.)

1. An implantable device, comprising:

a sealed flexible first shell configured for implantation within a breast of a human subject;

an elastomeric filler material contained within the sealed flexible first housing;

a sealed flexible second housing disposed within the resilient filler material inside the sealed flexible first housing; and

a volume of gas contained within the sealed flexible second housing such that the volume of the gas is less than a threshold inflation volume required to induce a non-zero strain in the sealed flexible second housing when the device is subjected to an external pressure of one atmosphere.

2. The implantable device of claim 1, wherein the elastomeric filling material comprises a silicone gel.

3. The implantable device of claim 1, wherein the volume of gas comprises a volume of air.

4. The implantable device of claim 1, wherein the volume of the gas comprises 85% of the threshold inflation volume.

5. A method for manufacturing an implantable device, the method comprising:

providing a sealed flexible first shell configured for implantation within a breast of a human subject;

filling the sealed flexible first shell with an elastomeric filling material;

disposing a sealed flexible second housing within the resilient filler material located inside the sealed flexible first housing; and

inflating the sealed flexible second housing with a volume of gas such that the volume of the gas is less than a threshold inflation volume required to induce a non-zero strain in the sealed flexible second housing when the device is subjected to an external pressure of one atmosphere.

6. The method of claim 5, wherein filling the sealed flexible first housing comprises filling the sealed flexible first housing with a silicone gel.

7. The method of claim 5, wherein inflating the sealed flexible second housing comprises inflating the sealed flexible second housing with air.

8. The method of claim 5, wherein the volume of the gas is 85% of the threshold inflation volume.

Technical Field

The present invention relates generally to medical devices, and in particular to breast implants.

Background

Breast implants are inserted into or attached to the human breast in order to replace tissue that has been medically removed in procedures such as mastectomy. The purpose of a breast implant is to restore the original form of the breast, including its feel and weight. Breast implants may also be inserted into the breast to enhance or enlarge the appearance of the breast for cosmetic purposes.

British patent application GB2,388,780 describes a weight-reducing external breast implant comprising a body and one or more air bladders.

Us patent 4,125,117 describes a universal breast implant that can be used as a substitute for patients with epithelial flaps and symmetrical lateral flaps for the right or left breast as well as for patients with varying degrees of surgery, scarring, muscle removal, etc.

Us patent 8,205,356 describes an attempt to replicate the natural and effective anatomy, such as a bare foot, in footwear, orthotic and other products, which provides superior flexibility, cushioning and stable support compared to existing products.

Us patent 8,080,057 describes a method for optimal breast reconstruction including steps for performing a mastectomy with the skin envelope of the breast preserved.

Us patent 9,399,122 describes a method and system for a tissue expander that can function in conjunction with an extended tissue expander (such as an extended tissue expander to be temporarily implanted in a patient) to form a pocket for a permanent implant.

Disclosure of Invention

Embodiments of the present invention described below provide for improved breast implants.

Thus, according to an embodiment of the present invention, there is disclosed an implantable device comprising: a sealed flexible first shell configured for implantation within a breast of a human subject; an elastomeric filler material contained within the sealed flexible first housing; a sealed flexible second housing disposed within the resilient filler material inside the sealed flexible first housing; and a volume of gas contained within the sealed flexible second housing such that the volume of gas is less than a threshold inflation volume required to induce a non-zero strain within the sealed flexible second housing when the device is subjected to an external pressure of one atmosphere.

In one embodiment, the elastomeric filling material comprises a silicone gel.

In another embodiment, the volume of gas comprises a volume of air.

In another embodiment, the volume of gas is 85% of the threshold inflation volume.

There is also provided, in accordance with an embodiment of the present invention, a method for manufacturing an implantable device, including providing a sealed flexible first shell configured for implantation within a breast of a human subject, filling the sealed flexible first shell with an elastic filler material, disposing a sealed flexible second shell within the elastic filler material located inside the sealed flexible first shell, and inflating the sealed flexible second shell with a volume of gas such that the volume of gas is less than a threshold inflation volume required to induce a non-zero strain in the sealed flexible second shell when the device is subjected to an external pressure of one atmosphere.

In one embodiment, filling the sealed flexible first housing comprises filling the sealed flexible first housing with a silicone gel.

In another embodiment, inflating the sealed flexible second housing includes inflating it with air.

The invention will be more fully understood from the following detailed description of embodiments of the invention taken together with the accompanying drawings, in which:

drawings

FIG. 1 is a schematic cross-sectional view of a human female breast with a breast implant according to an embodiment of the present invention;

fig. 2 is a schematic perspective view of a first shell of a breast implant according to an embodiment of the present invention;

FIG. 3 is a schematic cross-sectional view of a polyamide/polyurethane (PA/PU) composite according to an embodiment of the present invention;

FIG. 4 is a schematic perspective view of a cut PA/PU composite prepared for Radio Frequency (RF) welding according to an embodiment of the present invention;

fig. 5 is a schematic perspective view of a second shell preform after RF welding two composite sheets according to an embodiment of the present invention;

fig. 6 is a schematic perspective view of a second housing preform after an inflation step according to an embodiment of the present invention;

fig. 7 is a schematic perspective view of a second housing preform after a sealing step according to an embodiment of the present invention;

fig. 8 is a schematic cross-sectional view of a complete breast implant according to an embodiment of the present invention; and is

Fig. 9 is a flow chart schematically illustrating a method for manufacturing a breast implant according to an embodiment of the present invention.

Detailed Description

SUMMARY

A commonly used breast implant is one in which an elastic filling material, such as a silicone gel, is contained in a sealed flexible first shell. However, breast implants that are completely filled with such materials are relatively heavy and may be uncomfortable for the wearer of the implant.

Embodiments of the present invention provide implantable devices for use as breast implants. The device includes a sealed flexible first shell configured for implantation within a breast of a human subject. An elastomeric fill material is contained within the flexible first shell and there is a sealed flexible second shell disposed within the elastomeric fill material.

A volume of gas is present within the sealed second housing, and the volume of gas is selected to be less than a threshold inflation volume. The threshold inflation volume is the volume of gas that induces a non-zero strain in the sealed second housing, and then subjects the device to an external pressure of one atmosphere.

Embodiments of the invention described herein address the possibility of gas leakage, so as to enable the construction of a breast implant equipped with a balloon-like second shell without significant gas leakage during the lifetime of the implant. This enables the construction and manufacture of a lightweight and stable breast implant.

The disclosed embodiments reduce any potential gas leakage below a preset limit by only partially inflating the second housing, as will be described in detail below.

Description of the System

Fig. 1 is a schematic cross-sectional view of a human female breast 20 having a breast implant 21 according to an embodiment of the present invention. Implant 21 includes a first housing 22 and a second housing 23, described in more detail below. In the disclosed embodiment, breast implant 21 is positioned as a breast implant between breast tissue 24 and pectoralis major 26. It will be appreciated by those skilled in the art that in alternative embodiments, the breast implant 21 may be positioned as a sub-fascial, sub-pectoralis, or sub-muscular implant, with reference to different positions of the implant relative to the pectoralis major muscle 26.

Fig. 2 is a schematic perspective view of the first shell 22 of the breast implant 21 according to an embodiment of the present invention. The first housing 22 is manufactured by repeatedly dipping a mandrel (not shown) in a silicone solution. The coating of silicone solution is cured between successive impregnations. Once a sufficient thickness of the silicone layer covering the mandrel has been reached (typically 0.1mm) and the silicone has cured, the silicone "skin" is peeled off the mandrel. The rod passing through the mandrel leaves an opening 62 in the first housing 22.

Fig. 3 is a schematic cross-sectional view of a polyamide/polyurethane (PA/PU) composite 70 according to an embodiment of the present invention. A PA/PU composite 70 (or similar flexible and non-elastic material) is used for the second housing 23. The flexibility of the second shell 23 allows the shell to adapt its shape to the changing shape of the implant 21 due to, for example, movement of the breast 20. The inelasticity of the second shell 23 prevents the shell, and thus the implant 21, from changing its dimensions in a low pressure environment (e.g., an aircraft).

The composite material 70 is manufactured by dipping a fine mesh of PA (polyamide) 72 in liquid PU (polyurethane) 74. The composite was then fed to two parallel rollers to flatten the sheet.

Fig. 4 is a schematic perspective view of a PA/PU composite 70 after being cut in preparation for Radio Frequency (RF) welding, according to an embodiment of the present invention. Two similarly shaped pieces are cut from the PA/PU composite 70 to form an upper composite sheet 80 and a lower composite sheet 82, which together form the second shell preform 76. As described below, the sheets 80 and 82 are used to form the second housing 23, and the shape of the sheets 80 and 82 may be circular, square, or any other desired shape of the second housing 23. After RF welding, extensions 84 are left on each component to form fill tubes 86 (shown in fig. 5).

Fig. 5 is a schematic perspective view of the second shell preform 76 after RF welding of the upper and lower composite sheets 80 and 82, respectively, according to an embodiment of the present invention. The upper and lower composite sheets 80, 82 have been RF welded together along weld lines 90, respectively, positioned at the periphery of the sheets. In this process, a fill tube 86 has been formed from the extension 84 for inflating the second shell preform 76.

Fig. 6 is a schematic perspective view of the second housing preform 76 after it has been partially inflated, according to an embodiment of the invention. Since the second shell preform 76 is partially inflated by the fill tube 86, the upper and lower composite sheets 80 and 82, respectively, form a balloon-like volume.

By partially inflated is meant that the second enclosure is subjected to gas while the enclosure is subjected to an external pressure of one atmosphereIs inflated to the volume V<V_th. Threshold inflation volume V of the second housing_thIs defined as the inflated volume that will induce a non-zero strain in the shell. When the gas is at a pressure of one atmosphere, the volume of the housing and the volume of the gas are the same. Typical value of V is V_th85% of the total. Partial inflation (rather than full inflation) of the second shell reduces the potential diffusion of gas into the elastomeric filling material of the implant to below a preset limit.

Fig. 7 is a schematic perspective view of a complete second shell 23 formed from a preform 76, according to an embodiment of the present invention. The initial RF weld 90 has been completed with a sealing RF weld 94, thus completely sealing the volume of gas between the upper composite sheet 80 and the lower composite sheet 82, respectively. In addition, the portion of the fill tube 86 outside the edge of the second shell preform 76 has been cut away.

Fig. 8 is a schematic illustration of a complete breast implant 21 according to an embodiment of the present invention. The complete second housing 23 (fig. 7) has been inserted into the first housing 22 (fig. 2) through the opening 62. The second housing 23 is further fixed in place by a ring of cement 130, which attaches the second housing to the first housing 22. The cement 130 also closes the interior of the first casing 22, enabling subsequent filling of the first casing without leaking filling material, as will be described below. Elements 132, 133, 134, and 136 are described further below.

Fig. 9 is a flow chart 230 schematically illustrating a method for manufacturing a breast implant 21 according to an embodiment of the present invention. The method splits from start step 232 into two paths 234 and 236. The path 234 leads to a first housing fabrication step 238 that includes fabricating the first housing 22 by dip casting as described above with reference to fig. 2. The path 236 leads to step 240 and 246 for manufacturing the second housing 23. In a material manufacturing step 240, the composite material 70 for the second shell 23 is manufactured as described above in connection with fig. 3. In the cutting and welding step 242, the two pieces 80 and 82 of composite material 70 are cut to shape and attached to one another to form the second shell preform 76 with the fill tube 86, as described above with reference to fig. 4-5. In the partial inflation step 244, the second shell preform 76 is partially inflated with gas, as described above with reference to fig. 6. In a sealing step 246, the partially inflated second housing preform 76 is sealed with RF welding and the fill tube 86 is severed as described above with reference to fig. 7. The result of the sealing step 246 is a complete second housing 23.

Steps 238 and 240-246 may be implemented in series or in parallel. These steps converge in a second housing insertion step 250, wherein the complete second housing 23 is inserted and secured in the first housing 22, as described above with reference to fig. 8. With further reference to fig. 8, in a capping step 252, the opening 62 is closed using a cap 136 of the same material as the first housing 22. In addition to the cement 130, the use of the cap 136 further secures the implant 21 against leakage of the resilient filler material 132.

In an implant filling step 254, the first housing 22 is filled with the resilient filling material 132 using a syringe (not shown) through the housing wall 133 at location 134 until a predetermined volume of material has been injected. A typical volume of the breast implant 21 is 800 cc. If the second housing 23 is not inserted into the first housing, the entire 800cc volume will be filled with silicone, weighing approximately 800 g. The volume of the second shell is typically 30-40% of the total volume of the breast implant 21, resulting in a reduction of 30-40% of the volume of 800cc of injected silicone, which in turn reduces the weight of the implant by 30-40% of the weight of 800 g.

The elastomeric filling material 132 typically comprises a two-part silicone gel. The silicone gel is a viscous liquid and is injected simultaneously by syringe. Prior to injecting the silicone gel into the first housing 22, air bubbles are removed from the gel under vacuum.

Once the silicone gel typically solidifies at an elevated temperature of about 160 ℃, the injection hole at location 134 is sealed in a sealing step 256 using the same material as used to fabricate first shell 22, and the construction of the breast implant is terminated (in a finishing step 258).

The breast implant 21 is depicted in fig. 8 as having an elliptical cross-sectional shape. However, due to the flexibility of the material of the first shell 22 and the complete second shell 23 and the elasticity of the filling material 132, it will adapt its shape to the surrounding tissue, as shown in fig. 1.

According to the inventors' experiments, embodiments of the present invention reduce the weight of the implant by 30-35% without affecting its tactile properties by introducing a sealed second shell into the filler material in the first shell.

It will be appreciated that the embodiments described above are cited by way of example, and that the present invention is not limited to what has been particularly shown and described hereinabove. Rather, the scope of the present invention includes both combinations and subcombinations of the various features described hereinabove, as well as variations and modifications thereof which would occur to persons skilled in the art upon reading the foregoing description and which are not disclosed in the prior art.