Conserving microprosthesis reconstruction device

Abstract

The utility model provides a kind of breast conserving microprosthesis reconstruction device, it is suitable for the repair of partial loss of breast, including microprosthesis, flexible patch and filling gun;The microprosthesis forms airtight filling cavity inside, and the microprosthesis after filling has front surface and rear surface, fixed pull ear is equipped on the edge of the microprosthesis;The flexible patch is connected with the fixed pull ear, and the flexible patch only wraps the front surface of the microprosthesis, the rear surface of the microprosthesis is not wrapped with the flexible patch, and the edge of the flexible patch is provided with suture frame for being sutured and fixed with breast gland body;The filling gun is used to inject filling material matched with the volume of breast surgery defect into the microprosthesis inside.The device can prevent chest muscle adhesion, is fixed firmly, and is shaped and beautiful.

Description

Technical Field

[0001] This utility model relates to the field of medical device technology, specifically to a breast-conserving micro prosthesis reconstruction device. Background Technology

[0002] Currently, minimally invasive breast-conserving surgery has become the mainstream clinical procedure for breast cancer. To ensure clean surgical margins, varying degrees of tissue loss in the breast tissue are common after tumor removal. Women with medium to large breast cups often experience problems such as local dimpling and breast asymmetry after surgery. Women with small breast cups may even lose the opportunity for breast-conserving surgery due to the excessive removal of breast tissue. Existing repair methods mostly use autologous tissue transfer, skin flap transplantation, and fat transplantation. Autologous tissue repair can cause secondary trauma to other parts of the body, skin flap transplantation is highly complex, and fat transplantation has poor stability. Conventional breast implants are mostly used in total mastectomy reconstruction and are not suitable for repairing local defects after partial mastectomy. Simply reducing the size of the implant also lacks an effective fixation structure, making it prone to displacement after surgery and difficult to accurately adapt to local defects of different sizes, resulting in poor shaping effects.

[0003] To prevent implant displacement, current methods often involve suturing a patch to the implant, and then suturing the patch to the surrounding tissue. For example, Chinese utility model patent CN220275772U, entitled "A Breast Implant Structure for Easy Fixation," uses two patches sutured together to form a complete closed capsule, completely enclosing the implant inside. The front and back sides of the implant are fully covered by the patch, and a fixation piece with suture holes is provided around the capsule to fix the tissue. While this approach allows for integrated assembly of the implant and patch outside the body and simplifies intraoperative suturing, it has significant clinical drawbacks: After the back of the implant fully covers the patch, the patch directly adheres to the pectoralis major muscle during implantation, making it highly susceptible to tissue fusion and adhesion between the pectoralis major muscle and the back patch postoperatively; during muscle contraction and limb movement, the pectoralis major muscle pulls on the patch and implant, causing them to shift synchronously, resulting in persistent traction pain in the chest; under muscle tension, the implant in the adhesion area bulges locally due to traction, causing a stiff overall breast contour and preventing the natural sagging of breast tissue, which can lead to asymmetry in the appearance of both breasts in the long term, severely affecting the aesthetic results of breast reconstruction. Utility Model Content

[0004] This invention aims to at least partially solve one of the technical problems in the aforementioned technologies. Therefore, the purpose of this invention is to propose a breast-conserving micro-prosthetic reconstruction device. This device has a stable structure, can be matched to fill different tumor resection defect volumes, and achieves excellent breast reconstruction and shaping effects.

[0005] To achieve the above objectives, this utility model proposes a breast-conserving micro-prosthesis reconstruction device, suitable for the repair of local breast defects, comprising: a micro-prosthesis, a flexible patch, and an injection gun; The microprosthesis has a sealed filling cavity inside, and the filled microprosthesis has a front surface and a rear surface. The microprosthesis is provided with a fixing lug on its edge. The flexible patch is connected to the fixed pull ear. The flexible patch only covers the front surface of the micro prosthesis, and the rear surface of the micro prosthesis is not covered by the flexible patch. The edge of the flexible patch is provided with a suture frame for suturing and fixing with the mammary gland. The filling gun is used to inject filler that matches the volume of the breast surgery defect into the microprosthetic.

[0006] This invention discloses a breast-conserving micro-implant reconstruction device, which collaboratively reconstructs local breast defects using a micro-implant, a unilateral flexible patch, and an injection gun. The device covers only the anterior surface of the micro-implant with the flexible patch, leaving the posterior surface uncovered, thus avoiding the defects of pectoralis major muscle adhesion and traction caused by full coverage of the implant. The micro-implant is assembled with the flexible patch using edge-fixing lugs, and the outer suture frame of the flexible patch can be directly sutured and fixed to the incision edge of the breast tissue. This dual-limiting structure significantly reduces the risk of implant displacement. The injection gun allows for the precise injection of filler material during surgery, matching various breast defect volumes as needed. The overall structure conforms to the natural physiological shape of the breast, avoiding the pain of muscle traction and foreign body sensation, resulting in a natural and aesthetically pleasing breast reconstruction.

[0007] In addition, the breast-conserving micro-prosthetic reconstruction device proposed in the above embodiments of this utility model may also have the following additional technical features: Optionally, the flexible patch has a first hole, and the fixing lug has a second hole that matches the first hole. The flexible patch and the fixing lug are connected through the first hole and the second hole.

[0008] Optionally, the flexible patch may be a biological flexible patch or a medical polymer synthetic flexible patch.

[0009] Optionally, the microprosthetic is provided with a self-sealing tubing, and the filling gun injects filler from the self-sealing tubing.

[0010] Optionally, the injection port of the microprosthetic is sealed with medical sealant.

[0011] Furthermore, the injection port of the self-sealing hose is located at the edge of the microprosthetic, and the self-sealing hose extends toward the interior of the microprosthetic.

[0012] Optionally, the filler is silicone gel, physiological saline, or sterile inert gas.

[0013] Optionally, the flexible patch is arranged in a grid pattern.

[0014] Optionally, the filling gun is an electric filling gun.

[0015] Optionally, the front surface of the microprosthetic is an arc-shaped surface, and the rear surface of the microprosthetic is a plane. Attached Figure Description

[0016] Figure 1 This is a schematic diagram of the combined structure of the micro prosthesis and flexible patch according to an embodiment of the present invention; Figure 2 This is a schematic diagram of the structure of one embodiment of the microprosthetic according to the present invention; Figure 3 This is a schematic diagram of another embodiment of the microprosthetic according to the present invention; Figure 4 for Figure 3 A structural diagram from another perspective; Figure 5 This is a schematic diagram of the structure of the flexible patch according to an embodiment of the present utility model; Explanation of reference numerals in the attached figures: Micro prosthesis 1, fixing lug 11, second hole 12, self-sealing soft tube 13, flexible patch 2, suture frame 21, first hole 22; The filling gun is not shown in the attached drawings. Detailed Implementation

[0017] The embodiments of this utility model are described in detail below. Examples of these embodiments are shown in the accompanying drawings, wherein the same or similar reference numerals denote the same or similar elements or elements having the same or similar functions throughout. The embodiments described below with reference to the accompanying drawings are exemplary and intended to explain this utility model, and should not be construed as limiting this utility model.

[0018] To better understand the above technical solutions, exemplary embodiments of the present invention will be described in more detail below with reference to the accompanying drawings. Although exemplary embodiments of the present invention are shown in the drawings, it should be understood that the present invention can be implemented in various forms and should not be limited to the embodiments set forth herein. Rather, these embodiments are provided to enable a more thorough understanding of the present invention and to fully convey the scope of the present invention to those skilled in the art.

[0019] To better understand the above technical solutions, the following will provide a detailed explanation of the technical solutions in conjunction with the accompanying drawings and specific implementation methods.

[0020] The following is for reference. Figures 1-5 The implementation of the breast-preserving micro prosthesis 1 reconstruction device proposed in this embodiment of the present invention will be described in detail.

[0021] The breast-conserving micro-prosthesis reconstruction device according to the present invention is suitable for the repair of local defects in the breast, and includes: a micro-prosthesis 1, a flexible patch 2, and an injection gun; Specifically, the micro-implant 1 forms a closed filling cavity inside, and the filled micro-implant 1 has a front surface and a rear surface. The micro-implant 1 is provided with a fixing lug 11 on its edge. The flexible patch 2 is connected to the fixing lug 11. The flexible patch 2 only covers the front surface of the micro-implant 1, and the rear surface of the micro-implant 1 is not covered by the flexible patch 2. The edge of the flexible patch 2 is provided with a suture frame 21 for suturing and fixing with the mammary gland. The filling gun is used to inject filler that matches the volume of the breast surgery defect into the filling cavity.

[0022] In other words, this breast-conserving micro-implant reconstruction device includes a hemispherical micro-implant 1, a flexible patch 2, and an injection gun. The micro-implant 1 is made of silicone, and its outer wall is integrally molded with a pair of fixing lugs 11. The flexible patch 2 can be a biological flexible patch 2 or a medical-grade polymer synthetic flexible patch 2. The flexible patch 2 only covers the anterior surface of the micro-implant 1, leaving the posterior surface of the micro-implant 1 completely exposed without a patch, thus avoiding the pectoralis major muscle adhesion problem caused by full coverage of the capsule. If a structure is used to fully cover the micro-implant 1 with a patch, the pectoralis major muscle is prone to fusion with the back patch tissue after surgery. During limb movement, the micro-implant 1 and the flexible patch 2 will be continuously pulled, causing local pain. When the muscle tightens, the micro-implant 1 will bulge locally, and the breast cannot hang naturally, resulting in asymmetry in the shape of the two breasts, which seriously affects the aesthetics of the reconstruction. The flexible patch 2 has a suture frame 21 at its edge, which can be directly sutured and fixed to the residual breast tissue after surgery. Combined with the connection structure between the fixing lug 11 and the flexible patch 2, it forms a double-limiting fixation, promoting the growth and fusion of breast tissue and the flexible patch 2, and significantly reducing the risk of postoperative displacement of the micro-prosthesis 1. The interior of the hemispherical micro-prosthesis 1 is a closed filling cavity. During the operation, the defect volume can be accurately calculated by the water volume replacement method of the excised specimen. After the micro-prosthesis 1 and the flexible patch 2 are assembled outside the body, it is implanted into the defect area through a minimally invasive incision in the armpit, areola, or inframammary fold. Then, silicone gel, physiological saline, or sterile inert gas is quantitatively injected into the filling cavity of the micro-prosthesis 1 through an injection gun to complete the filling. After filling, the injection port can be sealed depending on the characteristics of the filler. For example, silicone gel has strong viscosity and does not easily leak, so no additional sealing is required. The entire device has a stable structure and can be individually adapted to breast defects of different resection ranges, resulting in a natural shaping effect. It is suitable for local defect repair during breast-conserving surgery for breast cancer, repair of local depressions after breast-conserving surgery, and local filling and correction of various breast deformities. The anterior and posterior surfaces of the filled micro-implant can both be curved surfaces, with the radius of curvature of the anterior surface being smaller than that of the posterior surface, or the anterior surface can be curved and the posterior surface can be flat.

[0023] Therefore, this breast-conserving micro-implant reconstruction device reconstructs local breast defects through the coordinated action of a micro-implant 1, a unilateral flexible patch 2, and an injection gun. The device only covers the anterior surface of the micro-implant 1 with the flexible patch 2, leaving the posterior surface uncovered, thus avoiding the defects of pectoralis major muscle adhesion and traction caused by full coverage of the capsule. The micro-implant 1 is assembled and connected to the flexible patch 2 via edge fixing lugs 11, and the peripheral suture frame 21 of the flexible patch 2 can be directly sutured and fixed to the incision edge of the breast tissue. This dual-limiting structure significantly reduces the risk of micro-implant 1 displacement. The injection gun allows for the precise injection of filler material during surgery, matching various breast defect volumes as needed. The overall structure conforms to the natural physiological shape of the breast, avoiding the pain of muscle traction and foreign body sensation, resulting in a natural and aesthetically pleasing breast reconstruction.

[0024] Optionally, the flexible patch 2 has a first hole 22, and the fixing lug 11 has a second hole 12 that matches the first hole 22. The flexible patch 2 and the fixing lug 11 are connected through the first hole 22 and the second hole 12. Understandably, the first hole 22 and the second hole 12 can be fixedly connected by sutures, clips, or other methods, making assembly simple and the connection strong. This allows the flexible patch 2 to stably adhere to the outside of the micro-prosthesis 1, ensuring a secure connection. This modular assembly structure can be pre-assembled externally and then inserted as a whole into the breast defect location through a small endoscopic incision in the armpit, perfectly meeting the operational space and procedural requirements of minimally invasive breast-conserving surgery.

[0025] Optionally, the flexible patch 2 can be either a biological flexible patch 2 or a medical-grade polymer synthetic flexible patch 2. Understandably, the biological flexible patch 2 is generally made of decellularized dermal matrix material, exhibiting excellent biocompatibility and gradually integrating with human breast tissue, effectively reducing postoperative rejection and capsular contracture. The medical-grade polymer synthetic flexible patch 2 can be made from commonly used medical polymer materials such as biological patches, titanium-plated polypropylene, polypropylene, polytetrafluoroethylene, and polyester. These materials have stable physicochemical properties, good flexibility, and high durability. Both types of flexible patches 2 have a flexible sheet-like structure, which not only limits and protects the micro-prosthesis 1 but also evenly distributes tissue tension at the affected area. Clinically, the choice of material can be flexibly selected based on the patient's physical condition and surgical situation.

[0026] Optionally, the microprosthesis 1 is equipped with a self-sealing tubing 13, through which the filling gun injects the filler. Understandably, in some embodiments, the microprosthesis 1 is equipped with a self-sealing tubing 13, which is a flexible medical tubing structure. When the filling gun is connected and pressure is applied, the tubing is open; after the filler is injected, the tubing quickly rebounds and closes due to its own elasticity, automatically sealing the injection channel. This structure eliminates the need for manual sealing, simplifying the intraoperative procedures during laparoscopic surgery and preventing leakage of internal silicone from the source.

[0027] Optionally, the injection port of the microprosthetic 1 is sealed with medical sealant. Understandably, in some other embodiments, the injection port does not need to be pre-set on the microprosthetic 1. After the microprosthetic 1 and flexible patch 2 are implanted, the filling gun punctures the wall of the microprosthetic 1 to establish a filling channel. After filling, the filling gun needle is removed, and medical sealant is applied to the injection port formed by the puncture to seal it. After the sealant cures, it can completely seal the puncture gap, preventing leakage of the filling material. This solution has a simpler structure, reduces the processing difficulty of the prefabricated tubing of the microprosthetic, and is suitable for use with microprosthetics for small-volume defects.

[0028] Furthermore, the injection port of the self-sealing tube 13 is located at the edge of the micro-implant 1, and the self-sealing tube 13 extends toward the interior of the micro-implant 1. Understandably, the injection port of the self-sealing tube 13 is located in the edge area of ​​the micro-implant 1, close to the minimally invasive incision after implantation, allowing for easy docking of the filling gun during surgery without the need for deep manipulation within the breast tissue; the tube extends inward into the filling cavity, allowing for even dispersion of the filling material during silicone gel filling, avoiding local accumulation that could cause unilateral protrusion of the implant, ensuring a symmetrical and flat breast shape, and improving postoperative aesthetics.

[0029] Optionally, the filler can be silicone gel, saline solution, or sterile inert gas. Medical-grade silicone gel is soft and its elasticity closely resembles that of human breast fat gland tissue. After being filled into the sealed cavity of the micro-implant 1, the breast feels natural and realistic. Its physicochemical properties are stable, it does not easily degrade in the body, and it will not cause inflammatory stimulation to the surrounding breast tissue and chest wall. Furthermore, its fluidity is moderate, allowing for precise control of the filling dosage using an electric filling gun. Individualized filling can be performed based on the measured volume of the breast defect during surgery, effectively avoiding problems such as localized unevenness and asymmetry caused by overfilling or underfilling. Saline solution is inexpensive and easy to prepare intraoperatively; if the volume of the micro-implant 1 needs to be adjusted postoperatively, it can be aspirated. Sterile inert gas has no tissue irritation and is suitable for short-term intraoperative shaping and temporary filling. Clinically, the filler can be flexibly selected according to the size of the patient's defect, surgical needs, and long-term repair goals.

[0030] Optionally, the flexible patch 2 is arranged in a grid pattern. Understandably, the grid-like perforated structure provides growth and attachment space for surrounding mammary glands and connective tissue. Postoperatively, newly formed tissue can pass through the grid openings and fuse with the patch, further enhancing the fixation effect of the implant and significantly reducing the risk of implant displacement and local slippage. At the same time, the grid structure has good air permeability, reducing postoperative complications such as residual cavity effusion, fat necrosis, and adhesions. It will not obstruct local blood supply when used by radiotherapy patients.

[0031] Optionally, the filling gun is an electric filling gun. Understandably, the electric filling gun can adopt an existing structure. The electric filling gun can set quantitative filling parameters and accurately output filler according to the preoperatively measured defect volume. Compared with manual injection guns, it has higher filling accuracy and eliminates filling deviation caused by uneven manual injection force. The device has a built-in digital volume display, which can be read intuitively under laparoscopy during the operation. It is convenient and controllable to operate and adapts to the needs of minimally invasive laparoscopic surgery.

[0032] Optionally, the anterior surface of the micro-implant is curved, and the posterior surface is flat. Understandably, the anterior curved surface of micro-implant 1 conforms to the subcutaneous glandular tissue of the breast, and its curved contour matches the natural outward convex physiological shape of the breast, resulting in a full and rounded breast appearance post-surgery, conforming to the aesthetics of the original breast curve. The posterior plane is completely exposed without the flexible patch 2 covering it, and its flat, straight surface conforms to the pectoralis major fascia. The absence of a barrier patch between the two minimizes the contact area with the foreign body, structurally preventing adhesion and fusion between the flexible patch 2 and the pectoralis major muscle. When the patient raises their arms or expands their chest, causing the pectoralis major muscle to contract and relax, the back of the micro-implant 1 plane can slightly slide along the pectoralis major fascia to buffer the traction stress, preventing the micro-implant 1 from being continuously pulled and displaced by the muscle, or causing local bulging and protrusion. This significantly reduces post-operative chest traction pain while preserving the natural sagging and dynamic deformation of the breast, maintaining long-term symmetrical and aesthetically pleasing bilateral breasts.

[0033] This breast-conserving micro-implant reconstruction device boasts differentiated core advantages, significantly improving upon the shortcomings of fully encapsulated pouch-type breast implants: the micro-implant 1 and the mesh-like flexible patch 2 are pre-assembled externally using fixing lugs 11 and corresponding holes. The suture frame 21 around the flexible patch 2 can be sutured and fixed to the breast tissue, while the mesh-like perforated structure allows for the inward growth and fusion of autologous tissue. This dual-limiting mechanism fundamentally prevents postoperative displacement of the micro-implant 1. The flexible patch 2 can be made of biological or medical-grade polymer materials, greatly reducing postoperative complications such as capsular contracture and pectoralis major muscle adhesion. The micro-implant 1 has a self-sealing soft tube 13 built into its edge, which automatically seals the channel after filling. It can also be used with medical sealant to seal the puncture injection site, with this dual structure preventing the risk of filler leakage. The accompanying electric filling gun can precisely and quantitatively inject silicone gel into the cavity of the micro-implant 1, allowing for individualized matching of different surgical defect volumes and ensuring the breast is shaped to conform to the original breast tissue. The combination of micro-prosthesis 1 and flexible patch 2 is foldable and can be implanted into the surgical area through a minimally invasive incision. It does not require autologous skin flaps, avoids additional secondary trauma to patients, and is suitable for laparoscopic minimally invasive breast-conserving surgery of various defect sizes. It also takes into account the needs of minimally invasive operation and the aesthetic effect of breast reconstruction.

[0034] In the description of this utility model, it should be understood that the terms "center", "longitudinal", "lateral", "length", "width", "thickness", "upper", "lower", "front", "rear", "left", "right", "vertical", "horizontal", "top", "bottom", "inner", "outer", "clockwise", "counterclockwise", etc., indicating the orientation or positional relationship are based on the orientation or positional relationship shown in the accompanying drawings, and are only for the convenience of describing this utility model and simplifying the description, and are not intended to indicate or imply that the device or element referred to must have a specific orientation, or be constructed and operated in a specific orientation, and therefore should not be construed as a limitation of this utility model.

[0035] Furthermore, the terms "first" and "second" are used for descriptive purposes only and should not be construed as indicating or implying relative importance or implicitly specifying the number of technical features indicated. Thus, a feature defined as "first" or "second" may explicitly or implicitly include one or more of that feature. In the description of this utility model, "a plurality of" means two or more, unless otherwise explicitly specified.

[0036] In this utility model, unless otherwise explicitly specified and limited, the terms "installation," "connection," "joining," and "fixing," etc., should be interpreted broadly. For example, they can refer to a fixed connection, a detachable connection, or an integral part; they can refer to a mechanical connection or an electrical connection; they can refer to a direct connection or an indirect connection through an intermediate medium; they can refer to the internal communication of two components or the interaction between two components. Those skilled in the art can understand the specific meaning of the above terms in this utility model according to the specific circumstances.

[0037] In this invention, unless otherwise explicitly specified and limited, "above" or "below" the second feature can include direct contact between the first and second features, or contact between the first and second features through another feature between them. Furthermore, "above," "over," and "on top" of the second feature includes the first feature directly above or diagonally above the second feature, or simply indicates that the first feature is at a higher horizontal level than the second feature. "Below," "below," and "under" the second feature includes the first feature directly below or diagonally below the second feature, or simply indicates that the first feature is at a lower horizontal level than the second feature.

[0038] In the description of this specification, the references to terms such as "one embodiment," "some embodiments," "example," "specific example," or "some examples," etc., indicate that a specific feature, structure, material, or characteristic described in connection with that embodiment or example is included in at least one embodiment or example of the present invention. The illustrative expressions of the above terms in this specification should not be construed as necessarily referring to the same embodiment or example. Furthermore, the specific features, structures, materials, or characteristics described may be combined in any suitable manner in one or more embodiments or examples. In addition, those skilled in the art can combine and integrate the different embodiments or examples described in this specification.

[0039] Although embodiments of the present invention have been shown and described above, it is understood that the above embodiments are exemplary and should not be construed as limiting the present invention. Those skilled in the art can make changes, modifications, substitutions and variations to the above embodiments within the scope of the present invention.

Claims

1. A breast-conserving micro-prosthetic reconstruction device, suitable for repairing local breast defects, characterized in that, include: Micro-prostheses, flexible patches, and filling guns; The microprosthesis has a sealed filling cavity inside, and the filled microprosthesis has a front surface and a rear surface. The microprosthesis is provided with a fixing lug on its edge. The flexible patch is connected to the fixed pull ear. The flexible patch only covers the front surface of the micro prosthesis, and the rear surface of the micro prosthesis is not covered by the flexible patch. The edge of the flexible patch is provided with a suture frame for suturing and fixing with the mammary gland. The filling gun is used to inject filler material into the filling cavity that matches the volume of the breast surgery defect.

2. The breast-conserving micro-prosthetic reconstruction device according to claim 1, characterized in that, The flexible patch has a first hole, and the fixed lug has a second hole that matches the first hole. The flexible patch and the fixed lug are connected through the first hole and the second hole.

3. The breast-conserving micro-prosthetic reconstruction device according to claim 1, characterized in that, The flexible patch is selected from biological flexible patches or medical polymer synthetic flexible patches.

4. The breast-conserving micro-prosthetic reconstruction device according to claim 1, characterized in that, The microprosthesis is equipped with a self-sealing hose, and the filling gun injects filler from the self-sealing hose.

5. The breast-conserving micro-prosthetic reconstruction device according to claim 1, characterized in that, The injection port of the microprosthetic is sealed with medical sealant.

6. The breast-conserving micro-prosthetic reconstruction device according to claim 4, characterized in that, The injection port of the self-sealing hose is located at the edge of the microprosthetic, and the self-sealing hose extends toward the interior of the microprosthetic.

7. The breast-conserving micro-prosthetic reconstruction device according to claim 1, characterized in that, The filler is silicone gel, physiological saline, or sterile inert gas.

8. The breast-conserving micro-prosthetic reconstruction device according to claim 1, characterized in that, The flexible patch is arranged in a grid pattern.

9. The breast-conserving micro-prosthetic reconstruction device according to claim 1, characterized in that, The filling gun is an electric filling gun.

10. The breast-conserving micro-prosthetic reconstruction device according to claim 1, characterized in that, The front surface of the microprosthetic is arc-shaped, and the rear surface of the microprosthetic is flat.

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