Bag-shaped suture-free patch suitable for prosthesis shape and used for breast reconstruction

Abstract

The invention belongs to the technical field of medical materials, and discloses a bag-shaped suture-free patch suitable for a prosthesis shape for breast reconstruction, which comprises a film cover and an opening, the bottom of the film cover is provided with an opening. The shape of the patch is perfectly matched with that of the prosthesis, the step of sewing and cutting the patch is omitted, the operation time can be shortened by 30-60 minutes, and roughness and unevenness caused by thread knots are avoided. And the technical difficulty (such as narrow space operation as endoscopic surgery) related to suture is reduced. The short-term effect is as follows: the suture-free patch can realize immediate stability, and the prosthesis is more fit. The long-term effect is as follows: after the patch is integrated with the tissue, the suture-free patch is smoother in palpation, and the rotation and displacement risks of the prosthesis can also be reduced. Function retention: chest muscle injury is avoided through chest muscle front placement, and the upper limb function recovery time of a patient can be shortened by 1-2 weeks;

Description

TECHNICAL FIELD

[0001] The present application belongs to the technical field of medical materials, and particularly relates to a bag-shaped suture-free patch suitable for the shape of a prosthesis for breast reconstruction. BACKGROUND

[0002] The use of a patch for breast pectoral prosthesis reconstruction is an important progress in the field of breast reconstruction in recent years, and the core is to wrap the prosthesis by a specially designed patch material (such as a titanium-coated polypropylene mesh or a biological patch) to achieve stable fixation of the prosthesis and reduce the risk of capsule contracture. The traditional patch, whether it is a Tiloop patch or a biological patch, needs to be sutured to wrap the prosthesis in the operation process. Not only is the operation time long and the risk of infection increased, but also the shape of the patch does not match the shape of the prosthesis, resulting in the need to cut the excess patch. At the same time, the patch needs to be sutured and knotted at multiple places in order to completely wrap the prosthesis, and the knots are difficult to completely absorb, and the postoperative palpation of the breast may touch the uneven tissue. For the case of placing a larger volume prosthesis (350mL or more) in the operation, a single patch is obviously insufficient to cover the prosthesis, and two patches are often needed, which inevitably leads to an increase in price and further waste of materials. The principle of the suture-free patch is to make the patch into a completely closed mesh bag-shaped patch capsule that is conformal to the prosthesis. Only a 5-7cm long opening (depending on the size of the prosthesis diameter) is made on the plane of the patch, the prosthesis can be directly placed into the capsule, and then the prosthesis and the patch are placed into the subcutaneous cavity of the pectoral muscle, without the need for further suture to close the patch, solving the problems of long operation time, excessive suture leading to uneven palpation of the local area, and difference in the fit of the patch and the prosthesis during each operation.

[0003] Through the above analysis, the problems and defects of the prior art are:

[0004] In the operation process, the patch needs to be sutured to wrap the prosthesis, not only is the operation time long, the risk of infection is increased, and the shape of the patch does not match the shape of the prosthesis, resulting in the need to cut the excess patch. At the same time, the patch needs to be sutured and knotted at multiple places in order to completely wrap the prosthesis, and the knots are difficult to completely absorb, and the postoperative palpation of the breast may touch the uneven tissue. For the case of placing a larger volume prosthesis (350mL or more) in the operation, a single patch is obviously insufficient to cover the prosthesis, and two patches are often needed, which inevitably leads to an increase in price and further waste of materials. SUMMARY

[0005] In view of the problems existing in the prior art, the present application provides a bag-shaped suture-free patch suitable for the shape of a prosthesis for breast reconstruction.

[0006] The application is achieved by a suture-free patch for breast reconstruction, which is a bag-shaped suture-free patch suitable for the shape of a prosthesis, comprising an integrally formed film cover and an opening arranged at the bottom of the film cover; the film cover is bag-shaped, the outer surface is a microporous structure, and the inner surface is a smooth structure, which can be matched with the shape of a breast prosthesis; the edge of the opening is coated with a medical hydrogel self-adhesive layer, which is used to realize automatic sealing and fixation on the surface of the tissue of the receiving area after the prosthesis is placed.

[0007] Further, the opening extends along the circumference of the bottom of the film cover, and the length of the opening is 5 cm to 7 cm.

[0008] Further, the film cover is made of a cell-free dermal matrix material and is formed by thermal molding, and the thickness of the cover body is 0.3 mm to 0.6 mm.

[0009] The application also provides a preparation method of a suture-free patch, which comprises the following steps:

[0010] a) providing a cell-free dermal matrix sheet and cutting it to a predetermined size;

[0011] b) hot pressing the sheet into a bag-shaped film cover corresponding to the shape of a breast prosthesis at a temperature of 80℃ to 110℃;

[0012] c) forming an opening at the bottom of the film cover by laser cutting;

[0013] d) uniformly coating a medical hydrogel on the edge of the opening and solidifying to form a self-adhesive layer;

[0014] e) sterilizing the obtained film cover by γ-rays and packaging it in a sterile manner.

[0015] The application also provides a breast reconstruction system, which comprises the suture-free patch according to any one of claims 1 to 3 and a medical silicone prosthesis arranged in the film cover; the self-adhesive layer is attached to the surface of the tissue of the receiving area after the prosthesis is implanted to form a closed cavity, thereby realizing suture-free fixation.

[0016] The application also provides a method for prosthesis reconstruction of the pectoral muscle after breast cancer surgery by using the above-mentioned suture-free patch, which comprises the following steps:

[0017] a) placing a medical silicone prosthesis into the film cover of the patch;

[0018] b) placing the assembled prosthesis together with the patch into the anterior intermuscular space of the pectoral muscle through a breast incision;

[0019] c) attaching the self-adhesive layer of the patch to the surface of the chest wall tissue to realize positioning and fixation of the prosthesis without suture;

[0020] d) closing the incision to complete breast reconstruction.

[0021] In combination with the above technical solutions and the technical problems solved, the technical solutions to be protected by the present application have the following advantages and positive effects:

[0022] The suture-free patch provided by the present application is a one-piece, bag-shaped structure of a prosthesis covering device, and the overall contour is highly matched with the breast prosthesis. The patch is made of titanium-coated polypropylene material and has a single convex shape, with the curved surface in contact with the skin and the flat surface attached to the pectoralis major muscle. In order to facilitate the placement of the prosthesis during surgery, a 5-7 cm transverse linear opening is designed at the bottom of the flat surface, and the prosthesis can be directly placed into the patch through the opening. The opening is pressed by the tension of the prosthesis itself after surgery, and does not need to be sutured to be stably closed, achieving the reconstruction effect of suture-free, free cutting, and quick placement during surgery.

[0023] Compared with traditional patches, the present technology eliminates the need for additional cutting and suturing procedures, significantly shortening the operation time (which can be reduced by about 20-60 minutes), and avoiding the problem of uneven palpation caused by knots or mesh wrinkles during surgery. At the same time, this design is particularly suitable for breast reconstruction surgery under endoscopy, which can reduce the dependence on suturing techniques when operating in a narrow space, thereby widening the scope of endoscopy and simplifying the operation path.

[0024] From the perspective of therapeutic effect, the present application can achieve immediate fitting and stability of the prosthesis during surgery, and good fusion with the tissue after surgery, which can effectively reduce the risk of complications such as prosthesis rotation and displacement. Since the patch and the prosthesis are integrally formed, there is no need for multiple patches to be spliced, and the overall touch is more uniform and natural. The patch is placed in front of the pectoral muscle, avoiding the damage to the pectoralis major muscle caused by traditional submuscular placement, allowing the patient to recover faster after surgery, and the recovery time is expected to be shortened by 1-2 weeks.

[0025] The patch technology also performs outstandingly in terms of surgical safety and cost control. The reduction in operation steps can reduce the risk of intraoperative infection, and when a large volume prosthesis is implanted, the previous two-piece patch splicing fixation scheme can be replaced by a single suture-free patch, significantly saving materials and reducing the use of surgical consumables. Although the price of a single piece of material is slightly higher (increased by about 15-20%), the overall medical cost tends to decrease due to time compression and accelerated postoperative recovery.

[0026] The present application fills the gap in the field of "pre-pectoral placement of suture-free reconstruction patch" at home and abroad. Its unique geometric structure and self-stabilizing closure design not only greatly simplifies the breast prosthesis reconstruction process, but also breaks through the technical bottleneck of the traditional "submuscular placement + suture wrapping" mode, creating a more efficient, safer, and more anatomically compatible reconstruction method, providing a better solution for post-mastectomy repair.

[0027] The suture-free patch can further realize standardized and serialized production in cooperation with manufacturers to meet the needs of different body types and prosthesis sizes. Combined with endoscopic and robot-assisted surgical methods, technical iteration can realize more accurate prosthesis placement and patch deployment. At the same time, with the clinical promotion, the product is expected to show more extensive social and economic value in improving the quality of life of patients and optimizing the allocation of medical resources. BRIEF DESCRIPTION OF DRAWINGS

[0028] Fig. 1 is a structure diagram of a bag-shaped suture-free patch suitable for prosthesis morphology for breast reconstruction provided by the embodiment of the present application.

[0029] Fig. 2 is a structure diagram of a bag-shaped suture-free patch suitable for prosthesis morphology for breast reconstruction provided by the embodiment of the present application.

[0030] Fig. 3 is a back view of a bag-shaped suture-free patch suitable for prosthesis morphology for breast reconstruction provided by the embodiment of the present application.

[0031] In the figure: 1, film cover; 2, opening; 3, microporous structure. DETAILED DESCRIPTION

[0032] In order to make the purpose, technical scheme and advantages of the present application clearer, the present application will be further described in detail below in combination with embodiments. It should be understood that the specific embodiments described herein are only used to explain the present application and do not limit the present application.

[0033] The long-term clinical dependence on suture-fixed allogeneic dermal patch in the prosthesis reconstruction scene of the pectoral muscle exposes two major problems: first, the two-dimensional flat patch inevitably has wrinkles and stress concentration on the three-dimensional prosthesis curved surface, and the doctor can only repeatedly trim and suture to match as much as possible, passively lengthening the operation time; second, multiple suture punctures not only destroy the overall mechanical continuity of the patch, but also provide a hidden path for bacterial “tunneling”. In order to solve this contradiction, the research and development team takes “self-adaptive three-dimensional covering” as the core target and proposes an integrated suture-free patch idea, which completes the geometric registration of the prosthesis and the biological patch at one time through the bag-shaped structure.

[0034] On the material level, the patch body is selected from a decellularized dermal matrix, which retains a collagen fiber cross-linking network after gradient enzymolysis and ultrasonic microperforation, and the outer surface has a continuous micropore of 50-120 μm, which is beneficial to early blood vessel growth; the inner surface is polished by cold plasma, and the roughness is reduced to Ra 0.4 μm, which significantly inhibits bacterial adhesion and fibrin deposition. The periphery of the bag opening is pre-coated with a polyacrylic acid hydroxypropyl cellulose-chitosan interpenetrating network hydrogel, which is a dry gel membrane at room temperature, expands rapidly and forms a self-adhesive interface within 30 seconds in a physiological ionic environment, and the shear strength can be stably maintained at more than 35 kPa.

[0035] The forming process adopts double-mold differential pressure thermoplastic. First, the leather sheet is subjected to primary heat pressing at 95℃ and 0.3MPa to preliminarily obtain a dome-shaped appearance; then, corresponding to the target prosthesis specifications (tangent radius, polar height and base diameter), the sheet is subjected to secondary shaping by means of a 3D negative pressure cavity mold to ensure that the uniformity of the bag wall thickness is not more than 0.05mm. By introducing radial pre-tensioning in the thermoplastic stage, the patch will produce a small amount of retraction after being pressed in the body, keeping the prosthesis in a state of sticking without edge lifting.

[0036] The intraoperative operation is extremely simplified: the doctor slides the silicone gel prosthesis into the bag on the sterile table surface, and lightly pinches the bag opening to temporarily close it; after implanting the prosthesis into the pectoral muscle anterior compartment, the hydrogel of the bag opening is activated by tissue fluid, enters the ion exchange-space network rearrangement stage, forms a continuous self-adhesive layer and completes viscoelastic coupling with the pectoral fascia surface, and the whole process does not require a single suture. The initial fixation is completed within 3 minutes, and the stable strength that can withstand turning and pulling is reached after 20 minutes.

[0037] In the dimensions of mechanics and histology, the bag-type patch provides 360° uniform coverage for the prosthesis, eliminating the traditional "suture point-suture point" stress peaks and reducing the incidence of early frictional bleeding and serum edema. The microporous outer layer promotes the penetration of capillary plexus within 14 days, and collagen type III is gradually replaced by type I, forming a continuous new fibrous capsule at the patch-fascia-prosthesis interface, but the capsule wall thickness is only 40% of that of the conventional suture group, significantly reducing the late capsular contracture.

[0038] In summary, the suture-free patch realizes four technical breakthroughs of shortening the surgical process, closing the infection channel, homogenizing the mechanical stress and long-term biological integration through the double mechanisms of one-piece forming geometric fitting and hydrogel instantaneous self-adhesion, completely eliminating the dependence on sutures, and providing a safer, more efficient and more in line with the trend of tissue engineering solution for pectoral muscle prosthesis reconstruction.

[0039] As shown in Figs. 1-3 The embodiment of the present application provides a bag-shaped suture-free patch suitable for the shape of a breast prosthesis.

[0040] The bottom of the film cover 1 is provided with an opening 2.

[0041] The opening 2 provided by the embodiment of the present application has a length of 5-7cm.

[0042] The film cover 1 provided by the embodiment of the present application is a one-piece bag-shaped. The outer surface is a microporous structure 3, and the inner surface is a smooth structure, which can be matched with the shape of the breast prosthesis; the opening edge is coated with a medical hydrogel self-adhesive layer, which is used to realize automatic sealing and fixation on the tissue surface of the recipient area after the prosthesis is placed.

[0043] The suture-free patch design is directly designed as an integrated bag-shaped capsule consistent with the shape of the prosthesis. Different capsule sizes can wrap different sizes of prosthesis. Since the prosthesis is one side of the arc-shaped convex, and the other side is a plane, in order to facilitate the prosthesis into the patch, the plane side of the patch is designed with a linear opening of 5-7cm. After the prosthesis is placed in the patch bag, the prosthesis and the patch are placed in the subcutaneous cavity created after the breast cancer surgery, and the plane side directly contacts and fits the surface of the pectoral muscle. Therefore, the suture gap on the plane side of the patch does not need to be sutured, and in the natural state, it will be fused with the pectoral muscle tissue to fix the prosthesis. The arc-shaped convex side contacts the skin. Therefore, it solves the problems of long operation time, too much suture leading to uneven palpation, and difference in the fit of the patch and the prosthesis during each operation. It is a powerful weapon to break the barrier of the patch used in the operation of breast prosthesis reconstruction.

[0044] The present application has completed more than one hundred operations by using traditional patch wrapping prosthesis. The present application only improves the way of wrapping the prosthesis, which is more beneficial to implanting into the breast subcutaneous cavity, but has no effect on the operation steps of breast cancer surgery

[0045] The above is only a specific embodiment of the present application, but the protection scope of the present application is not limited thereto. Any modification, equivalent replacement and improvement within the technical range disclosed by the present application, which is made by any person skilled in the art within the spirit and principle of the present application, should be covered within the protection scope of the present application.

Claims

1. A pocket-like sutureless patch suitable for the form of a prosthesis for breast reconstruction, characterized in that, The film cover is in the shape of a bag, the outer surface is of a microporous structure, the inner surface is smooth, and can be matched with the shape of the breast prosthesis; the edge of the opening is coated with a medical hydrogel self-adhesive layer, which can automatically adhere and seal the prosthesis after being implanted and fixed on the surface of the tissue of the recipient.

2. The sutures-free mesh according to claim 1, characterized in that, The opening extends along the bottom of the film cover in a circumferential direction, and the length of the opening is 5-7 cm.

3. The sutures-free mesh according to claim 1, characterized in that, The film cover is made of acellular dermal matrix material by thermal plastic forming, and the thickness of the cover is 0.3-0.6 mm.

4. A method of making a sutureless patch, characterized by, The method comprises the following steps: a) providing an acellular dermal matrix sheet and cutting it to a predetermined size; b) hot pressing the sheet into a bag-shaped film cover corresponding to the shape of the breast prosthesis at a temperature of 80-110 DEG C; c) forming an opening in the bottom of the film cover by laser cutting; d) uniformly coating the edge of the opening with medical hydrogel and solidifying to form a self-adhesive layer; e) sterilizing the obtained film cover by gamma rays and packaging it aseptically.

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