Surgical body fluid and / or tissue isolating membrane

Abstract

The invention discloses a body fluid and / or tissue isolating membrane for operation, the isolating membrane can be placed in a body, the isolating membrane comprises an adsorption layer, and the adsorption layer can adsorb body fluid and / or tissue flowing out of an object to be resected in the body in the resection process. And iatrogenic dissemination and planting caused by overflow of body fluid and / or tissues in the to-be-cut object can be avoided. After adsorption is completed and the cyst or the solid tumor is cut off, the isolating membrane is placed in the specimen bag, the isolating membrane is compressed and taken out of the umbilical hole after the body fluid in the adsorption layer is sucked out through the negative pressure device, and therefore the situation that body fluid tissue in the tumor overflows and is disseminated in the cyst or solid tumor resection operation can be avoided.

Description

Technical Field

[0001] The present invention relates to the technical field of medical devices, and particularly to a body fluid and / or tissue isolation membrane for surgery. Background Art

[0002] The progress of laparoscopic surgery has made it possible to remove most benign abdominal cysts. Compared with traditional laparotomy, laparoscopic surgery has the advantages of less trauma, shorter hospital stay and faster recovery, and is favored by patients due to its better aesthetic effect.

[0003] However, in terms of the oncological safety of laparoscopic minimally invasive surgery, whether tumor resection meets the "tumor-free principle" has caused controversy. This is mainly because iatrogenic cyst rupture and spillage of the contents of malignant masses in laparoscopic minimally invasive surgery can upgrade the disease stage, resulting in the need for adjuvant chemotherapy and may damage the overall survival of patients.

[0004] Some researchers believe that at present, rupture of serous cystadenoma and dermoid cyst does not affect the postoperative morbidity, because the pelvic cavity is repeatedly irrigated during the operation, and generally does not affect the residual contents of the dermoid cyst. Ovarian mucinous cyst and peritoneal mucinous tumor are two tumors with different biological behaviors. Therefore, even if there is a little spillage during the operation and it is repeatedly washed clean, it will not affect the prognosis. However, in fact, for patients with tumor rupture and spillage during the operation, their follow-up requirements are more stringent, and both patients and surgeons will face greater psychological pressure. For individual patients with early malignant tumors that have not been identified, the adverse outcomes caused by failed surgery are irreparable.

[0005] The risks of iatrogenic cyst rupture and spillage of the contents of malignant masses in the selection of laparoscopic cyst or other solid tumor resection are related to factors such as cyst size, nature, surgical method, surgeon's operation ability, and laparoscopic equipment research and development. Although there is a certain boundary between cysts and normal tissues, continuously improving the technical operation ability and retaining normal tissues and functions under certain conditions are also the pursuits of the continuous development of medicine. Objective problems such as huge pelvic masses affecting the surgical field of vision, narrow intraoperative operation space, uneven distribution of the gap between tumors and normal tissues, and incomplete accuracy of preoperative tumor evaluation cause iatrogenic cyst rupture and spillage of the contents of malignant masses, and once malignant tumors cause iatrogenic dissemination and implantation, it directly affects the prognosis of patients.

[0006] Therefore, the above-mentioned prior art has at least the following technical problems: Laparoscopic minimally invasive surgery is prone to iatrogenic cyst rupture and spillage of the contents of malignant masses, resulting in a relatively high risk of iatrogenic dissemination and implantation. Summary of the Invention

[0007] Embodiments of the present application provide a surgical body fluid and / or tissue isolation membrane, which solves the technical problem in the prior art that laparoscopic minimally invasive surgery is prone to iatrogenic cyst rupture and malignant mass content overflow, resulting in a relatively high risk of iatrogenic dissemination and implantation.

[0008] To solve the above technical problem, embodiments of the present application provide a surgical body fluid and / or tissue isolation membrane. The isolation membrane can be placed in the body, and the isolation membrane includes an adsorption layer. The adsorption layer can adsorb the body fluid and / or tissue flowing out during the resection of the object to be resected in the body, so as to prevent the body fluid and / or tissue in the object to be resected from overflowing and spreading.

[0009] Furthermore, the isolation membrane can be curled to facilitate entry and exit from the human body.

[0010] Furthermore, the isolation membrane can be shaped to wrap or partially wrap around the object to be resected, or be laid under the object to be resected;

[0011] The adsorption layer faces the object to be resected to adsorb the body fluid and / or tissue flowing out during the resection of the object to be resected.

[0012] Furthermore, the adsorption layer is a sponge and / or foam having the function of adsorbing body fluid and / or tissue.

[0013] Furthermore, the adsorption layer is a nano polyurethane sponge and / or polyvinyl formal foam.

[0014] Furthermore, an anti-slip structure for increasing friction is formed on the adsorption layer to prevent the tissue or mucus falling on the adsorption layer from shifting.

[0015] Furthermore, the anti-slip structure is a fold disposed on the outer surface of the adsorption layer.

[0016] Furthermore, the isolation membrane further includes an auxiliary layer connected to the adsorption layer;

[0017] The auxiliary layer has elasticity and can be shaped to drive the adsorption layer to be shaped.

[0018] Furthermore, the auxiliary layer is a shapeable metal layer.

[0019] Furthermore, the auxiliary layer is a metal woven mesh.

[0020] Furthermore, the auxiliary layer is made of titanium-nickel alloy and / or nickel-titanium-cobalt (NiTiCo) alloy.

[0021] Furthermore, the adsorption layer is adhesively fixed to the auxiliary layer.

[0022] The above one or more technical solutions in the embodiments of the present application have at least one or more of the following technical effects:

[0023] (1) The isolation membrane described in the embodiment of the present application is provided with an adsorption layer. After the isolation membrane is curled and compressed and enters the surgical cavity through the umbilical surgical approach, the isolation membrane can be unfolded and laid in the surgical dissemination risk area (below the area where the cyst or solid tumor to be removed is located) to physically separate the cyst or solid tumor from the surrounding tissues and organs, or the isolation membrane can be wrapped around the cyst or solid tumor to be removed after being shaped by surgical instruments; during the cyst or solid tumor removal process, the adsorption layer can absorb the body fluid and / or tissue flowing out of the cyst or solid tumor to avoid the overflow and dissemination of body fluid and tissue in the tumor; after the cyst or solid tumor is removed, the isolation membrane is placed in a specimen bag, and after the body fluid and / or tissue in the adsorption layer is sucked out by a laparoscopic negative pressure suction device, the isolation membrane is curled and compressed by a laparoscopic grasping forceps and the isolation membrane is removed from the umbilical hole.

[0024] (2) The isolation membrane also includes an auxiliary layer, which is elastic and can be molded, that is, it can maintain a certain shape under the action of external force. In this way, the auxiliary layer can force the adsorption layer to be molded synchronously, and the isolation membrane can be wrapped or partially wrapped on the cyst or solid tumor to be removed, so that in the process of cutting the cyst or solid tumor, the adsorption layer can wrap and adsorb the body fluids and / or tissues flowing out of the cyst or solid tumor to prevent them from overflowing and spreading; of course, the isolation membrane can also be laid in the surgical dissemination risk area (below the area where the cyst or solid tumor to be removed is located) to physically separate the cyst or solid tumor from the surrounding tissues and organs, and to absorb the body fluids and / or tissues dripping from the cyst or solid tumor.

[0025] (3) Since the auxiliary layer is elastic and can be shaped, the auxiliary layer can also drive the adsorption layer to curl and fold under the action of external force, and the curling and folding conform to the isolation membrane through the umbilical hole, thereby facilitating entry and exit of the human surgical area.

[0026] (4) An anti-slip structure for increasing friction is provided on the upper surface of the adsorption layer. When the adsorption layer wraps a cyst or a solid tumor, the anti-slip structure can hinder the shedding of larger particles of tissue or the displacement of mucus, thereby further reducing the risk of tissue dissemination. BRIEF DESCRIPTION OF THE DRAWINGS

[0027] In order to more clearly illustrate the embodiments of the present invention or the technical solutions in the prior art, the drawings required for use in the embodiments or the description of the prior art will be briefly introduced below. Obviously, the drawings described below are only some embodiments of the present invention. For ordinary technicians in this field, other drawings can be obtained based on these drawings without paying creative work.

[0028] Figure 1 Structural schematic of a body fluid and / or tissue isolation membrane for surgery in an embodiment of the present invention Figure 1 ;

[0029] Figure 2 Structural schematic of a body fluid and / or tissue isolation membrane for surgery in an embodiment of the present invention Figure 2 ;

[0030] Figure 3 Partial schematic diagram of the upper surface of the adsorption layer in an embodiment of the present invention;

[0031] Figure 4 Structural schematic diagram of the adsorption holes of the adsorption layer in an embodiment of the present invention;

[0032] Figure 5 Partial schematic diagram of the auxiliary layer in an embodiment of the present invention. Detailed implementation manners

[0033] By providing a body fluid and / or tissue isolation membrane for surgery in the embodiments of the present application, the technical problem in the prior art that laparoscopic minimally invasive surgery is prone to iatrogenic cyst rupture and malignant mass content overflow, resulting in a relatively high risk of iatrogenic dissemination and implantation, is solved.

[0034] To better understand the above technical solutions, the above technical solutions will be described in detail below in conjunction with the accompanying drawings of the specification and specific implementation manners.

[0035] As Figure 1 、 2 shown, in one or more embodiments of the present application, a body fluid and / or tissue isolation membrane for surgery is provided. The isolation membrane includes an adsorption layer 100 and an auxiliary layer 200 connected to the lower surface 120 of the adsorption layer 100. The adsorption layer 100 and the auxiliary layer 200 can be bonded and fixed into one body by glue. Of course, the adsorption layer 100 and the auxiliary layer 200 can also be connected by other means, such as snap connection, etc. In this way, the adsorption layer 100 and the auxiliary layer 200 are also detachable, and the auxiliary layer 200 can be reused, which is not limited herein.

[0036] During use, after curling and compressing the isolation membrane, it enters the surgical cavity through the umbilical orifice surgical approach. After unfolding the isolation membrane, the isolation membrane can be laid on the surgical dissemination risk area (below the area where the cyst or solid tumor to be removed is located) to physically separate the cyst or solid tumor from the surrounding tissue organs. In this way, during the resection of the cyst or solid tumor, the adsorption layer 100 can hold and adsorb the body fluid and / or tissue substance dripping from the cyst or solid tumor, thereby avoiding the spillage and dissemination of the body fluid and / or tissue substance; or after being shaped by surgical instruments, the isolation membrane is curled to wrap or partially wrap the cyst or solid tumor to be removed. In this way, during the resection of the cyst or solid tumor, the adsorption layer 100 can directly adsorb the body fluid and / or tissue substance in the tumor, thereby avoiding the spillage and dissemination of the body fluid and / or tissue substance. After completing the surgical operation, place the isolation membrane in the specimen bag, suck out the body fluid in the adsorption layer 100, and then compress it with instruments and remove the isolation membrane through the umbilical orifice.

[0037] As Figures 1 to 4 shown, the adsorption layer 100 is a sponge layer and / or foam layer with the function of adsorbing body fluid and / or tissue substance, on which adsorption holes 130 are formed, and the whole forms a sponge-like porous layered structure, having excellent elasticity, water absorption, and good biocompatibility. For example, the adsorption layer 100 can be a nano-polyurethane sponge and / or polyvinyl formal (PVF) foam.

[0038] Specifically, as a porous structure material, the nano-polyurethane sponge has a unique hierarchical porous structure (micropores, mesopores, and macropores), which makes it have strong adsorption performance and water absorption function; polyvinyl formal (PVF) foam is a foaming material obtained by using polyvinyl alcohol (PVAL) as the main raw material through a specific preparation process.

[0039] The above-mentioned nano-polyurethane sponge and polyvinyl formal (PVF) foam have the following advantages: (1) excellent elasticity and water absorption, capable of absorbing and storing a large amount of water; (2) good biocompatibility, having good compatibility in the living body and not causing rejection reactions; (3) wear resistance, having high wear resistance and being able to withstand a certain amount of friction and wear; (4) high mechanical flexibility; (5) high tear resistance; (6) high anti-permeability; (7) biodegradable; (8) non-toxic, harmless, and non-allergic. Therefore, the above-mentioned nano-polyurethane sponge and polyvinyl formal (PVF) foam are very suitable as the material for the adsorption layer 100. It should be noted that both the above-mentioned nano-polyurethane sponge and polyvinyl formal (PVF) foam can select mature products on the market.

[0040] Furthermore, the adsorption layer 100 includes an upper surface 110 for facing and / or contacting the cyst or solid tumor, and an anti-slip structure for increasing friction is formed on the upper surface 110 of the adsorption layer 100 to hinder the displacement of larger particles of detached tissue or mucus when the adsorption layer 100 wraps the cyst or solid tumor, thereby further reducing the risk of tissue dissemination.

[0041] In one embodiment of the present application, the anti-slip structure may be a fold 111 arranged on the upper surface 110 of the adsorption layer 100. For example, the fold 111 may be an arc-shaped fold, so that the upper surface 110 of the adsorption layer 100 is wavy. The fold 111 can not only increase the friction force, but also increase the surface area of ​​the adsorption layer 100, increase its contact area with the cyst or solid tumor, and thus improve the adsorption capacity. In addition, the fold 111 may be formed by die casting.

[0042] Of course, the anti-slip structure may also be a recessed structure (such as a groove) and / or a protruding structure (such as a convex point, a convex rib), etc., arranged on the upper surface 110 of the adsorption layer 100, which is not limited here.

[0043] The adsorption layer 100 is a soft layer, and the auxiliary layer 200 is elastic and can be shaped, that is, it can maintain a certain shape under the action of external force. In this way, the auxiliary layer 200 can force the adsorption layer 100 to curl and be shaped synchronously, so that the isolation membrane can wrap or partially wrap the cyst or solid tumor to be removed, so that in the process of cutting the cyst or solid tumor, the adsorption layer 100 can wrap and absorb the body fluids and / or tissues flowing out of the cyst or solid tumor to avoid overflow and dissemination. Of course, the isolation membrane can also be laid in the surgical dissemination risk area (below the area where the cyst or solid tumor to be removed is located) to physically separate the cyst or solid tumor from the surrounding tissues and organs, and to absorb the body fluids and / or tissues dripping from the cyst or solid tumor.

[0044] Specifically, the method of using the isolation membrane is selected according to the location and morphology of the cyst or solid tumor to be removed: if the cyst or solid tumor to be removed is relatively free (such as ovarian cyst / intestinal stromal tumor / gastric tumor in a non-adhesion state), the isolation membrane can be used to wrap / partially wrap the cyst or solid tumor; if the cyst or solid tumor to be removed is relatively fixed and has poor mobility (such as gallbladder / colon tumor / cystic lesions with local adhesions, etc.), after emptying the gap below the resection site or separating one side of the adhesion, the isolation membrane is laid under the cyst or solid tumor to physically separate the cyst or solid tumor from the surrounding tissues and organs, and one side of the adsorption layer 100 contacts or faces the cyst or solid tumor.

[0045] In addition, since the auxiliary layer 200 is elastic and can be shaped, the auxiliary layer 200 can also drive the adsorption layer 100 to curl and fold under the action of an external force, and conform to the placement of the isolation film through the umbilical hole by curling and folding, so as to facilitate entry and exit from the human surgical area.

[0046] For example, the auxiliary layer 200 can be a metal layer. For instance, the metal can be a shapeable titanium-nickel alloy, nickel-titanium-cobalt (NiTiCo) alloy, etc.

[0047] Specifically, titanium-nickel alloy and nickel-titanium-cobalt (NiTiCo) alloy have the following characteristics: (1) Shape memory effect, with a unique shape memory function, that is, the shape formed above a certain temperature can automatically return to its original shape when reheated to above a certain temperature after being cooled below a certain temperature and deformed; (2) Superelasticity, showing excellent superelasticity, that is, it can exhibit a larger elastic deformation than ordinary metals under a certain deformation without permanent deformation; (3) Biocompatibility, having good biocompatibility and being suitable for medical devices; (4) Corrosion resistance, with better corrosion resistance than the best medical stainless steel. Therefore, titanium-nickel alloy and nickel-titanium-cobalt (NiTiCo) alloy are very suitable as the material for the auxiliary layer 200.

[0048] Furthermore, as Figure 2 、 5 shown, the auxiliary layer 200 is a metal woven mesh, such as a shapeable titanium-nickel alloy woven mesh, nickel-titanium-cobalt (NiTiCo) alloy woven mesh, etc.

[0049] Specifically, the auxiliary layer 200 is in a mesh shape with mesh holes 210 thereon, which can not only reduce its own weight and facilitate surgical operation, but also reduce the material usage and cost, and can better curl.

[0050] Furthermore, the glue is a PGSA polymer with high-strength bioadhesive properties.

[0051] Specifically, PGSA polymer (polyglycerol sebacate) is a high-strength bioadhesive material with the following performance characteristics: (1) Biodegradability, PGSA polymer is a biodegradable polymer, which is very important for biomedical applications because it can reduce the long-term presence of implants in the body and reduce the risk of long-term complications; (2) Elasticity, having rubber-like elasticity because the ester bonds in its polymer backbone are covalently crosslinked to form a three-dimensional network structure, similar to vulcanized rubber; (3) Biocompatibility, PGSA polymer is made of glycerol and sebacic acid, both of which are metabolites of mammals, so it has good biocompatibility. Therefore, PGSA polymer is suitable as the glue.

[0052] Of course, other medical adhesives, such as soy protein bioadhesive, can also be used as the adhesive.

[0053] It should be noted that single-port laparoscopic surgery is divided into natural orifice transluminal endoscopic surgery (NOTES) and transumbilical single-port laparoscopic surgery. The former refers to the endoscopic system entering the human body through natural orifices, such as the oral cavity / anus / vagina, etc. for surgery; while the latter refers to the endoscopic system entering through the umbilical orifice for surgery. The single-port laparoscopic technique has not only been increasingly mature in the field of gynecology, but also in other surgical departments. With the research and development of variable-angle lenses and extended operating instruments for single-port laparoscopy, and the accumulation of surgeons' surgical experience, the single-port laparoscopic technique has been widely used in the diagnosis and treatment of various gynecological benign diseases and early malignant tumors, and has gradually ventured into the surgical treatment of high-difficulty gynecological malignant tumors.

[0054] Due to its unique minimally invasive and scarless effect, fast postoperative recovery, mild pain, and high patient satisfaction, especially in terms of the convenience of surgical instrument and device entry and exit from the body cavity, and the protection of the no-tumor principle during the separation and removal of specimens, the single-port laparoscopy has a better development trend and broader application prospects in clinical work. Therefore, the isolation membrane described in the embodiments of the present application is particularly suitable for single-port laparoscopic surgery, especially pelvic and abdominal cyst surgery, gallbladder surgery, etc.

[0055] An exemplary usage method of the surgical body fluid and / or tissue isolation membrane provided by the embodiments of the present application is as follows:

[0056] Place the curled isolation membrane into the surgical area such as the pelvic cavity through the natural orifice or the umbilical surgical incision path;

[0057] Separate the space around the cyst, cystic organ (such as the gallbladder, etc.) or solid tumor;

[0058] Place the isolation membrane under the cyst or solid tumor;

[0059] Change the shape of the isolation membrane through surgical operation so that it wraps / partially wraps the cyst or solid tumor, or is laid under the cyst or solid tumor to physically separate the cyst or solid tumor from the surrounding tissue organs, and the adsorption layer 100 faces the cyst or solid tumor;

[0060] During the process of cutting the tumor, the adsorption layer 100 adsorbs the body fluid and / or tissue discharged from the cyst or solid tumor to prevent spillage; if the cyst or solid tumor cannot be completely dissected or the risk of tumor rupture during dissection is relatively high, after separating the space under the tumor and placing the isolation membrane, cyst puncture decompression or tumor reduction can be performed, and then the cyst or solid tumor can be completely dissected or removed.

[0061] When the tumor resection is completed, aspirate the body fluid and / or tissue residue in the adsorption layer 100 through a laparoscopic negative pressure suction device;

[0062] Coil the isolation membrane again, place it into the retrieval bag, and then take it out through the natural orifice incision or umbilical port.

[0063] The use of the isolation membrane can minimize the risk of tumor fluid and tissue spillage and dissemination during the entire surgical process, with the technical effects of simple operation, stability and reliability, and effectively strengthening the principle of tumor-free surgery.

[0064] It should be understood that although terms such as "first" and "second" may be used herein to describe various units, these units should not be limited by these terms. These terms are only used to distinguish one unit from another. For example, without departing from the scope of the exemplary embodiments, the first unit may be referred to as the second unit, and similarly, the second unit may be referred to as the first unit.

[0065] The outer, middle, inner and other orientation terms mentioned or possibly mentioned in this specification are defined with respect to the structures shown in the respective drawings. They are relative concepts and may accordingly change depending on their different positions and usage states. Therefore, these or other orientation terms should not be construed as restrictive terms.

[0066] The above are only the preferred embodiments of the present application, and do not impose any formal or substantial limitations on the present application. It should be noted that for those of ordinary skill in the art in this technical field, without departing from the method of the present application, several improvements and supplements can still be made, and these improvements and supplements should also be regarded as the protection scope of the present invention. For those skilled in the art, without departing from the spirit and scope of the present application, any equivalent changes, modifications and evolutions made by using the technical content disclosed above shall be equivalent embodiments of the present application; at the same time, any equivalent changes, modifications and evolutions made to the above embodiments based on the substantial technology of the present application shall still fall within the scope of the technical solution of the present application.

Claims

1. A body fluid and / or tissue isolation membrane for surgery, characterized in that: The isolation membrane can be placed in the body, and the isolation membrane includes an adsorption layer (100). The adsorption layer (100) can absorb body fluids and / or tissues that flow out of the object to be resected in the body during the resection process, so as to prevent the body fluids and / or tissues in the object to be resected from overflowing and spreading.

2. A surgical body fluid and / or tissue isolation membrane as claimed in claim 1, characterized in that: The isolation membrane can be rolled up to facilitate entering and exiting the human body.

3. A surgical body fluid and / or tissue isolation membrane as claimed in claim 2, characterized in that: The isolation membrane can be shaped to wrap or partially wrap around the object to be resected, or to be laid under the object to be resected; The adsorption layer (100) faces the object to be resected so as to absorb body fluids and / or tissues discharged from the object to be resected during the resection process.

4. A surgical body fluid and / or tissue isolation membrane as claimed in claim 1, characterized in that: The absorbent layer (100) is a sponge and / or foam having the function of absorbing body fluids and / or tissues.

5. A surgical body fluid and / or tissue isolation membrane as claimed in claim 4, characterized in that: The adsorption layer (100) is nano polyurethane sponge and / or polyvinyl formal foam.

6. A surgical body fluid and / or tissue separation membrane according to any one of claims 1 to 5, characterized in that: An anti-slip structure for increasing friction is formed on the adsorption layer (100) to prevent the displacement of tissue or mucus that falls off the adsorption layer (100).

7. A surgical body fluid and / or tissue isolation membrane as claimed in claim 5, characterized in that: The anti-slip structure is wrinkles (111) arranged on the outer surface (110) of the adsorption layer (100).

8. A surgical body fluid and / or tissue isolation membrane as claimed in claim 3, characterized in that: The isolation film further comprises an auxiliary layer (200) connected to the adsorption layer (100); The auxiliary layer (200) is elastic and can be shaped to drive the adsorption layer (100) to be shaped.

9. A surgical body fluid and / or tissue isolation membrane as claimed in claim 8, characterized in that: The auxiliary layer (200) is a plastic metal layer; further, the auxiliary layer (200) is a metal woven mesh.

10. A surgical body fluid and / or tissue isolation membrane as claimed in claim 9, characterized in that: The auxiliary layer (200) is made of titanium-nickel alloy and / or nickel-titanium-cobalt alloy.

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