CN109745147B - Method for manufacturing full-autologous tissue double-layer envelope conformable breast prosthesis - Google Patents
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Abstract
The invention discloses a method for manufacturing a full-autologous tissue double-layer coated conformable breast prosthesis, which comprises the steps of obtaining a skin epidermal layer tissue, a dermis layer tissue and a subcutaneous fat tissue from a patient according to a pre-estimated cutting range and a pre-estimated volume, then placing the skin epidermal layer tissue and the skin layer-removed fat tissue into a sterile container, placing the sterile container into a water bath box with the temperature of 50-60 ℃ for warm bath for 20-40 minutes for inactivation, trimming and sewing the inactivated autologous fat tissue into conformable breast prosthesis contents with required shapes and sizes, sewing the inactivated skin epidermal layer tissue into an inner layer coated capsule of the conformable breast prosthesis contents according to the shapes and sizes of the conformable breast prosthesis contents, and sewing the dermis layer into an outer layer coated capsule of the conformable breast prosthesis contents. The method of the invention can prevent inflammatory cells of surrounding tissues from immersing after the prosthesis is implanted, prevent possible inflammatory reaction of prosthesis contents, avoid the risk of puncture and rupture of the prosthesis, and improve the toughness, elasticity, shape maintenance, extrusion resistance and other trauma capabilities of the manufactured prosthesis.
Description
Technical Field
The invention belongs to the technical field of human body prostheses, and particularly relates to a method for manufacturing a full-autologous tissue double-layer envelope conformable breast prosthesis.
Background
The benign and malignant lesions of the mammary gland require the operation to excise part and all glands, and the appearance of the breast after the operation can have the phenomena of local collapse, crater shape, oblique and retraction of nipples and the like due to the partial loss of the glands. When the shape of the breast is unacceptable, the breast can only be completely removed, with serious consequences. After partial glands are lost, the existing method for making up is to fill the lost area through the transfer of the ipsilateral latissimus dorsi valve, namely a molding operation, but no suitable conformal filling prosthesis is available at present. After all glands are lost, treatment methods such as implantation forming of a silica gel prosthesis, transfer forming of a skin flap with pedicles (rectus abdominis or latissimus dorsi), or combined application of the two methods are adopted.
However, the existing silicone gel prosthesis for breast molding is composed of two parts, namely a silicone capsule and liquid content such as silicone gel or normal saline, and is manufactured into oblate silicone capsules with limited shapes and sizes, and the oblate silicone capsules are completely filled into the vacancy of a mammary gland or the back of pectoralis major after the mammary gland is completely lacked, so that the breast is bulged to achieve the molding purpose.
The existing prosthesis is used for integrally implanting and filling the whole mammary gland after the whole mammary gland is lost, the shape is mostly similar to a hemisphere or an oblate, the size is designed according to the body form and the requirements of European and American women, for example, the diameter and the convexity of the bottom of the hemisphere and the height of the prosthesis are not suitable for the body form and the breast molding requirements of Asian women, the shape and the size types of the shape and the size manufactured by using a mold are limited, and the conformal filler required for cutting local glands due to different focus sizes in early breast cancer and breast benign lesions is difficult to solve, namely the conformal filler is suitable for different gland loss sizes, shapes, volumes and. The existing prosthesis is made of allogenic chemical materials, for example, the raw materials of the silica gel prosthesis are chemical foreign matters and are sourced from non-human autologous tissues, and after the prosthesis is implanted, allergy, rejection, carcinogenesis, puncture rupture, aging, displacement and slippage, contracture of envelope tissues around the prosthesis, psychological interference, limited storage time in vivo, need of operation and removal, serious side reaction and even toxic side reaction possibly occur due to the influence of the production quality of manufacturers and the like may exist. In addition, the existing prosthesis is a silica gel hemisphere, which cannot be directly sutured, and meanwhile, a patch material bag is required to support and fix the prosthesis at a proper position, and the patch is mainly imported, so that the price is high. The prosthesis is feared to be broken due to sharp puncture during and after the prosthesis implantation operation. The autogenous tissue valve breast shaping operation is used for breast plastic after partial mastectomy, mainly cuts the autogenous ipsilateral neurovascular pedicle latine muscle skin valve to transfer and fill a partial lacking area of a gland, the autogenous tissue valve shaping operation after the total mastectomy needs to cut the autogenous ipsilateral neurovascular pedicle latine muscle skin valve or rectus abdominus muscle skin valve to transfer and fill the deficient area of the gland, the integrity of the tissue structure of a supplying area is damaged, the tissue structure comprises beautiful appearance, sensory function, motor function and the like, the operation trauma and the operation complications including partial or total necrosis of the transferred muscle skin valve, the scar of the supplying area is increased, long-time hydrops under the skin are generated, and the forming effect is not satisfactory due to the waste atrophy of the transferred muscle.
Disclosure of Invention
The invention aims to provide a method for manufacturing a full-autogenous tissue double-layer envelope conformable breast prosthesis, which is used for manufacturing the full-autogenous tissue double-layer envelope conformable breast prosthesis, so as to overcome the problems in the background art and meet the requirement of filling the breast prosthesis.
In order to achieve the purpose, the technical scheme of the invention is as follows:
a method for manufacturing a full autologous tissue double-layer envelope conformable breast prosthesis comprises the following steps:
obtaining skin epidermal layer and dermal layer tissues and subcutaneous adipose tissues from a self-retrievable part of a patient according to a pre-estimated breast tissue resection range and amount;
respectively placing the cut skin epidermal layer and dermal layer tissues into a sterile container containing physiological saline, completely immersing the cut skin epidermal layer and dermal layer into the physiological saline liquid, and temporarily storing at room temperature for later use;
putting the epidermis layer and the skin layer-removed adipose tissues into a sterile container, and putting the sterile container into a water bath box at the temperature of 50-60 ℃ for warm bath for 20-40 minutes for inactivation;
trimming and sewing the inactivated autologous adipose tissues into a conformal breast prosthesis content with a required shape and size;
according to the shape and the size of the content of the conformal breast prosthesis, the inactivated skin surface tissue is sewn into an inner layer film bag of the content of the conformal breast prosthesis, and the dermis layer is sewn into an outer layer film bag of the content of the conformal breast prosthesis.
Preferably, the step of putting the epidermis layer and the adipose tissue without the skin layer into a sterile container, and putting the sterile container into a water bath box with the temperature of 50-60 ℃ for warm bath for 20-40 minutes for inactivation comprises the following steps:
putting the epidermis layer and the adipose tissue without the epidermis layer into a sterile container, and putting the sterile container into a water bath box with the temperature of 56 ℃ for warm bath for 30 minutes for inactivation.
Further, the trimming and sewing the inactivated autologous adipose tissue into the content of the conformal breast prosthesis with the required shape and size comprises the following steps:
and trimming and sewing the inactivated autologous adipose tissues into the content of the conformal breast prosthesis with the required shape and size under the sterile environment and room temperature condition.
Preferably, the room temperature is 15-25 ℃.
Further, according to the shape and the size of the content of the conformal breast prosthesis, the inactivated skin surface tissue is sewn into an inner layer membrane bag of the content of the conformal breast prosthesis, and the dermis layer is sewn into an outer layer membrane bag of the content of the conformal breast prosthesis, wherein when sewing is carried out, the specification of a sewing line is 4-0 or 5-0, the distance between every two needles is 2-3 mm, and the edge distance is 2-3 mm.
Optionally, the inactivated skin surface tissue is sewn into an inner layer membrane bag which is suitable for the content of the breast prosthesis, the dermis layer is sewn into an outer layer membrane bag which is suitable for the content of the breast prosthesis, and intermittent sewing is adopted.
Optionally, the inactivated skin surface tissue is sewn into an inner layer membrane bag which is suitable for the content of the breast prosthesis, the dermis layer is sewn into an outer layer membrane bag which is suitable for the content of the breast prosthesis, and continuous carpet edge type sewing is adopted.
Further, the inner layer capsule wraps the content of the conformal breast prosthesis, and the outer layer capsule wraps the outer surface of the inner layer capsule.
The invention provides a method for manufacturing a full-autologous tissue double-layer envelope adaptive breast prosthesis, which is characterized in that the prosthesis is made of autologous tissues of patients, overcomes the defect that the existing prosthesis is made of allogenic chemical materials, and avoids the defects of allergy, rejection, carcinogenesis, rupture, aging, psychological interference, limited storage time in vivo, need of operation for taking out, influence of the production quality of manufacturers, possibility of serious side reactions, even toxic and side reactions, catastrophe and the like after implantation due to the fact that the existing prosthesis is a source of autologous tissues. The range of the desirable autologous skin and subcutaneous adipose tissues is wide, such as the whole lower abdomen, the inner thighs at both sides and the like, the preparation requirements of the prosthesis after all breast glands with different sizes are lost can be met, and a conformal prosthesis can be prepared according to the specific lost shape and size of the breast glands, namely the conformal prosthesis is suitable for the different lost sizes, shapes, volumes and the like of the glands, so that the defects of the existing prosthesis are overcome, and the existing prosthesis is only used for filling and integrally implanting after the whole breast gland is lost; the shape and the size are designed according to the body types and requirements of European and American women, and are not suitable for Asian women; the shape and size of the mould are limited, and the problem of conformal filler and the like required by the removal of local glands due to different lesion sizes in early breast cancer and breast benign lesion is difficult to solve. The prosthesis prepared by the invention takes the skin and subcutaneous adipose tissues of the self-retrievable part, does not need to carry a vascular pedicle or keep blood supply by utilizing a vascular anastomosis technology, has small damage to tissue structures and functions of supply areas, no risk of complications such as transfer tissue flap necrosis and the like, no complications such as necrosis and the like of inactivated adipose tissues, small size atrophy amplitude and long shape maintenance time; the prosthesis manufacturing technology is simple and convenient, compared with the existing breast forming technology using the tissue valve with the vascular pedicle or vascular anastomosis to transfer, the breast forming technology greatly saves the operation time, reduces the operation wound, reduces the postoperative complications and avoids using high-value implanted consumables; autologous inactivated adipose tissue is used as the content, with the elastic texture closest to the autologous breast gland glandular tissue, without risk of rupture of the prosthesis by puncture. The invention uses double-layer coating, thus improving the toughness, elasticity, appearance maintenance and anti-extrusion ability of the manufactured prosthesis; the outer envelope of the prosthesis is self epidermis-removed dermis, can survive without a vascular pedicle, has good compatibility with surrounding tissues, and avoids complications such as capsular contracture around the prosthesis. The inner layer of the prosthesis is an inactivated autologous epidermal layer, blood supply is not needed, inflammatory cells of surrounding tissues can be prevented from being immersed after the prosthesis is implanted, and possible inflammatory reactions of contents of the prosthesis, such as complications of texture change of the prosthesis caused by tissue liquefaction, absorption, fibrosis, calcification and the like, can be prevented.
Drawings
FIG. 1 is a flow chart of the method for manufacturing the full autologous tissue double-layer envelope conformable breast prosthesis of the present invention.
Fig. 2 is a cross-sectional view of the fully autologous tissue double-layer capsule conformable breast prosthesis of the present invention.
Detailed Description
The technical solutions of the present invention are further described in detail below with reference to the drawings and examples, which should not be construed as limiting the present invention.
In one embodiment, the method for manufacturing the fully autologous tissue double-layer envelope conformable breast prosthesis comprises the following steps:
step S1, obtaining the epidermis and dermis layers of the skin and the subcutaneous adipose tissue from the self-proposed part of the patient according to the pre-estimated range and amount of the removed breast tissue.
The skin and subcutaneous adipose tissues of the self-available part of the patient are used, and the resection range and the size of the breast tissue are estimated according to the requirements of conventional anesthesia and surgical operation.
The requirements for routine anesthesia and surgical procedures are as follows: after the patient is in a horizontal position and general anesthesia is completed, 2% iodophor is used for disinfecting the skin of a supply area (a skin taking area and a subcutaneous fat area) for 2 times, a sterile towel is laid on the supply area conventionally, a drum type skin taking knife is used for cutting out a skin layer in a preset operation cutting range, then the skin corium layer with the skin removed is cut out by the drum type skin taking knife, finally subcutaneous fat is cut out on the superficial surface of a deep fascia, and the incision is sutured once. In this example, the whole epidermis of the skin was cut out using a drum-type skin cutter, and the whole epidermis without epidermis was removed.
According to the operation requirement, the fat tissue amount of one part of the lower abdomen of a common patient can meet the requirement of breast reconstruction operation, and if the skin amount is insufficient, skin can be additionally taken from other parts for preparing the prosthesis capsule. The method of skin incision and incision closure in the donor area is the same as described above.
Step S2, placing the cut skin epidermis and dermis tissues into sterile containers containing normal saline, completely immersing the cut skin epidermis and dermis in normal saline, and temporarily storing at room temperature for later use.
Placing epidermal layer and dermal layer into sterile cup or bag containing appropriate amount of normal saline, and completely soaking the epidermal and dermal tissues in normal saline liquid. The normal saline is in proper amount to completely contain the epidermis layer tissue and the dermis layer tissue.
Step S3, placing the epidermis layer and the adipose tissue with the skin layer removed into a sterile container, and placing into a water bath box with the temperature of 50-60 ℃ for warm bath for 20-40 minutes for inactivation.
Placing the epidermis layer tissue and the fat tissue without the epidermis layer into a sterile cup or a sterile bag, placing the sterile cup or the sterile bag into a water bath box at the temperature of 50-60 ℃ for warm bath for 20-40 minutes for inactivation, wherein the epidermis layer tissue is used for sewing an inner layer coating bag, and the fat tissue is used for preparing a content.
In a preferred embodiment, the water in the water bath is at a temperature of 56 degrees Celsius and is incubated for 30 minutes for inactivation.
In another embodiment, the water in the water bath is at a temperature of 50 degrees Celsius and is incubated for 40 minutes for inactivation.
In another embodiment, the water in the water bath is at a temperature of 60 degrees Celsius and is incubated for 20 minutes for inactivation.
Step S4, the inactivated autologous adipose tissue is trimmed and sewn into the content of the conformal breast prosthesis with the required shape and size.
The inactivated autologous adipose tissue is trimmed and sewn into the prosthesis contents of the desired shape and size, i.e., to conform to the breast prosthesis contents, depending on the amount of breast tissue surgically removed, including the shape, volume, and patient requirements for breast shape.
In one embodiment, 3D printing techniques may be utilized to fabricate conformal breast prosthesis contents.
Typically, the deactivated autologous adipose tissue is trimmed and sewn manually to the desired shape and size of the prosthesis contents.
When the inactivated autologous adipose tissues are trimmed and sewn into prosthesis contents with required shapes and sizes, the operation needs to be carried out in a sterile environment at room temperature, and the temperature is proper between 15 and 25 ℃.
And step S5, sewing the inactivated skin surface tissue into an inner layer membrane bag of the content of the conformal breast prosthesis according to the shape and the size of the content of the conformal breast prosthesis, and sewing the dermis layer into an outer layer membrane bag of the content of the conformal breast prosthesis.
In this embodiment, the inactivated epidermal layer tissue of the skin is sewn into the inner layer capsule of the conformal breast prosthesis according to the shape and size of the content of the conformal breast prosthesis, and during sewing, a non-damaged suture line is used as much as possible, the specification is about 4-0 to 5-0, the distance between needles is 2-3 mm, the margin (namely the distance from the needle eye to the edge of the suture) is 2-3 mm, and the suture can be performed discontinuously or continuously in a blanket-edge manner, so that the suture is tight.
The most basic principle of selecting the suture is as follows: sutures which are thin and strong and which have minimal tissue reaction are used to the greatest extent. The thickness of the various sutures is indicated in millimeters and zeros, with larger numbers indicating thicker sutures; the diameter of the suture is in millimeters and is often expressed in terms of a few 0. The thinner the suture line, the larger the number of 0 s. For example, 6 nylon threads of 0 are thinner than 4 nylon threads of 0. But in practice the thickness depends on the material of the suture. For example, 5 lines of 0, the gut line is thicker than the polypropylene synthetic line (ProleneTM). The principle of choice in terms of thickness is to select as thin a suture as possible, under conditions that can withstand the wound tension. Wire diameter specification 5-0# about 0.1-0.149 mm, 4-0# about 0.15-0.199 mm.
The de-skinned dermis (not inactivated) was fabricated into an outer envelope pouch conforming to the contents of the breast prosthesis using the same sewing method.
Wherein, the inner layer capsule wraps the content of the conformal breast prosthesis, and the outer layer capsule wraps the outer surface of the inner layer capsule.
In one embodiment, the fully autologous tissue double-layer capsule conformable breast prosthesis is shown in fig. 2, wherein 1 is the contents of the conformable breast prosthesis, 2 is the inner capsule, and 3 is the outer capsule.
The shape and volume of the fully autologous tissue double-layer envelope conformable breast prosthesis are determined according to the range and the volume of the patient to be removed, and are not limited to the shape shown in fig. 2, and the detailed description is omitted here.
The invention takes the inactivated adipose tissue as the content, the inactivated autologous epidermal layer as the inner layer envelope, and the inactivated autologous de-epidermal dermis as the outer layer envelope to prepare the conformal breast prosthesis of the full autologous tissue with double-layer envelope for the breast plastic surgery. Solves the serious side effects of allergy, rejection, carcinogenesis and the like possibly caused by the existing use of foreign body prosthesis. The autologous inactivated adipose tissues have elasticity as a whole, satisfactory hand feeling and proper weight, and the autologous inactivated epidermis prevents local inflammatory cells from immersing the prosthesis, so that possible liquefaction, necrosis, fibrosis, calcification and the like of the body contents are avoided; the self-skinning leather can survive and has toughness, good fusion degree with surrounding tissues, and good texture and hand feeling of the prosthesis. The autologous tissue source prosthesis is simple and convenient to manufacture, low in cost and not influenced by the production quality of manufacturers. The raw materials have zero cost and pollution, can be obtained from multiple parts, can be used for breast shaping after filling large local deletion of mammary gland, and whole breast filling shaping after complete deletion of mammary gland, and can also be used for simple breast cosmetology such as breast augmentation shaping.
In addition, the problem of operation complications such as severe operation wound and skin flap necrosis caused by unavoidable increase of supply area in the operation of the autologous tissue flap transfer molding with the vascular pedicle is solved. The inactivation time and temperature are tested repeatedly and proved to be effective and usable by pathological examination; the suture is tight, and no gap is left between the suture needle eye and the needle.
The above embodiments are only for illustrating the technical solution of the present invention and not for limiting the same, and those skilled in the art can make various corresponding changes and modifications according to the present invention without departing from the spirit and the essence of the present invention, but these corresponding changes and modifications should fall within the protection scope of the appended claims.
Claims (7)
1. A method for manufacturing a full autologous tissue double-layer envelope conformable breast prosthesis is characterized by comprising the following steps of:
respectively placing the autologous skin epidermis layer and dermis layer tissues of a patient into a sterile container containing physiological saline according to the pre-estimated breast tissue excision range and the pre-estimated breast tissue excision amount, completely immersing the epidermis layer and the dermis layer into the physiological saline liquid, and temporarily storing the epidermis layer and the dermis layer at room temperature for later use;
placing the epidermis layer and the adipose tissue of the patient with the skin layer removed into a sterile container, and placing the sterile container into a water bath box with the temperature of 50-60 ℃ for warm bath for 20-40 minutes for inactivation;
trimming and sewing the inactivated autologous adipose tissues into a conformal breast prosthesis content with a required shape and size;
according to the shape and the size of the content of the conformal breast prosthesis, the inactivated skin epidermal layer tissue is sewn into an inner layer membrane bag of the content of the conformal breast prosthesis, the dermis layer is sewn into an outer layer membrane bag of the content of the conformal breast prosthesis, the content of the conformal breast prosthesis is wrapped by the inner layer membrane bag, and the outer layer membrane bag is wrapped outside the inner layer membrane bag.
2. The method for manufacturing the full autologous tissue double-layer envelope conformable breast prosthesis according to claim 1, wherein the step of placing the epidermis layer and the adipose tissue of the patient with the skin layer removed from the patient into a sterile container, and then placing the container into a water bath box with a temperature of 50-60 ℃ for warm bath for 20-40 minutes for inactivation comprises the steps of:
and (3) placing the epidermis layer and the adipose tissue of the patient with the skin layer removed into a sterile container, and placing the sterile container into a water bath box with the temperature of 56 ℃ for warm bath for 30 minutes for inactivation.
3. The method for manufacturing a full autologous tissue double-layer envelope conformable breast prosthesis according to claim 1, wherein the trimming and sewing of the inactivated autologous adipose tissue into the conformable breast prosthesis content with desired shape and size comprises:
and trimming and sewing the inactivated autologous adipose tissues into the content of the conformal breast prosthesis with the required shape and size under the sterile environment and room temperature condition.
4. The method for manufacturing the fully autologous tissue double-layer capsule conformable breast prosthesis of claim 3, wherein the room temperature is 15-25 ℃.
5. The method for manufacturing a fully autologous tissue double-layer envelope conformable breast prosthesis according to claim 1, wherein the inactivated skin epidermis tissue is sewn into an inner layer envelope sac conforming to the content of the breast prosthesis according to the shape and size of the content of the conformable breast prosthesis, and the dermis layer is sewn into an outer layer envelope sac conforming to the content of the breast prosthesis, wherein the specification of the suture thread is 4-0 or 5-0, the needle pitch is 2-3 mm, and the margin is 2-3 mm during sewing.
6. The method for manufacturing a fully autologous tissue double-layer envelope conformable breast prosthesis according to claim 5, wherein the inactivated skin epidermal layer tissue is sewn into an inner layer envelope sac which conforms to the content of the breast prosthesis, and the dermis layer is sewn into an outer layer envelope sac which conforms to the content of the breast prosthesis, and the intermittent sewing is adopted.
7. The method for manufacturing a fully autologous tissue double-layer envelope conformable breast prosthesis according to claim 5, wherein the inactivated skin epidermal layer tissue is sewn into an inner layer envelope sac which conforms to the contents of the breast prosthesis, and the dermis layer is sewn into an outer layer envelope sac which conforms to the contents of the breast prosthesis, and continuous carpet edge sewing is adopted.
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| CN105078613A (en) * | 2009-07-21 | 2015-11-25 | 生命细胞公司 | Graft materials for surgical breast procedures |
| CN106264786A (en) * | 2016-09-24 | 2017-01-04 | 成都测迪森生物科技有限公司 | A kind of chest enhancement prosthesis |
| JP2018110869A (en) * | 2018-02-06 | 2018-07-19 | グンゼ株式会社 | Fatty tissue reconstruction member |
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| CN1133554A (en) * | 1993-09-07 | 1996-10-16 | 资料范围投资公司 | Improved soft tissue implant |
| CN1146324A (en) * | 1995-09-28 | 1997-04-02 | 张建军 | Breast prosthesis |
| CN1517077A (en) * | 2003-01-16 | 2004-08-04 | 中国医学科学院中国协和医科大学整形 | Anti-contractura type artificial breast |
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