CN117482286A - Multilayer composite patch with net piece banding structure - Google Patents
Multilayer composite patch with net piece banding structure Download PDFInfo
- Publication number
- CN117482286A CN117482286A CN202311474300.9A CN202311474300A CN117482286A CN 117482286 A CN117482286 A CN 117482286A CN 202311474300 A CN202311474300 A CN 202311474300A CN 117482286 A CN117482286 A CN 117482286A
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- Prior art keywords
- layer
- mesh
- bioabsorbable
- composite patch
- patch
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- 239000002131 composite material Substances 0.000 title claims abstract description 40
- 210000001035 gastrointestinal tract Anatomy 0.000 claims abstract description 22
- 239000000463 material Substances 0.000 claims abstract description 13
- 239000012528 membrane Substances 0.000 claims description 13
- 239000004743 Polypropylene Substances 0.000 claims description 7
- -1 polypropylene Polymers 0.000 claims description 7
- 229920001155 polypropylene Polymers 0.000 claims description 7
- 239000002033 PVDF binder Substances 0.000 claims description 4
- 238000010041 electrostatic spinning Methods 0.000 claims description 4
- 229920002981 polyvinylidene fluoride Polymers 0.000 claims description 4
- AEMRFAOFKBGASW-UHFFFAOYSA-N Glycolic acid Polymers OCC(O)=O AEMRFAOFKBGASW-UHFFFAOYSA-N 0.000 claims description 3
- 229920000954 Polyglycolide Polymers 0.000 claims description 3
- 238000010146 3D printing Methods 0.000 claims description 2
- 238000005266 casting Methods 0.000 claims description 2
- 238000000748 compression moulding Methods 0.000 claims description 2
- 238000007731 hot pressing Methods 0.000 claims description 2
- 238000009940 knitting Methods 0.000 claims description 2
- 229920000747 poly(lactic acid) Polymers 0.000 claims description 2
- 229920002463 poly(p-dioxanone) polymer Polymers 0.000 claims description 2
- 239000000622 polydioxanone Substances 0.000 claims description 2
- 229920000728 polyester Polymers 0.000 claims description 2
- 210000000683 abdominal cavity Anatomy 0.000 abstract description 20
- 238000007789 sealing Methods 0.000 abstract description 11
- 230000007547 defect Effects 0.000 abstract description 10
- 230000008439 repair process Effects 0.000 abstract description 9
- 230000003628 erosive effect Effects 0.000 abstract description 8
- 230000000694 effects Effects 0.000 abstract description 2
- 210000004872 soft tissue Anatomy 0.000 abstract description 2
- 230000017423 tissue regeneration Effects 0.000 abstract description 2
- 210000001519 tissue Anatomy 0.000 description 16
- 206010019909 Hernia Diseases 0.000 description 12
- CURLTUGMZLYLDI-UHFFFAOYSA-N Carbon dioxide Chemical compound O=C=O CURLTUGMZLYLDI-UHFFFAOYSA-N 0.000 description 8
- 238000002513 implantation Methods 0.000 description 8
- 238000000034 method Methods 0.000 description 6
- 210000000056 organ Anatomy 0.000 description 5
- 231100000241 scar Toxicity 0.000 description 5
- 238000001356 surgical procedure Methods 0.000 description 5
- 229910002092 carbon dioxide Inorganic materials 0.000 description 4
- 239000001569 carbon dioxide Substances 0.000 description 4
- VUZPPFZMUPKLLV-UHFFFAOYSA-N methane;hydrate Chemical compound C.O VUZPPFZMUPKLLV-UHFFFAOYSA-N 0.000 description 4
- 229920001059 synthetic polymer Polymers 0.000 description 4
- XLYOFNOQVPJJNP-UHFFFAOYSA-N water Substances O XLYOFNOQVPJJNP-UHFFFAOYSA-N 0.000 description 4
- 230000015572 biosynthetic process Effects 0.000 description 3
- 230000028709 inflammatory response Effects 0.000 description 3
- 208000034991 Hiatal Hernia Diseases 0.000 description 2
- 206010020028 Hiatus hernia Diseases 0.000 description 2
- 208000005646 Pneumoperitoneum Diseases 0.000 description 2
- 208000027418 Wounds and injury Diseases 0.000 description 2
- 230000000151 anti-reflux effect Effects 0.000 description 2
- 239000003292 glue Substances 0.000 description 2
- 208000015181 infectious disease Diseases 0.000 description 2
- 230000007170 pathology Effects 0.000 description 2
- 230000008569 process Effects 0.000 description 2
- 230000003014 reinforcing effect Effects 0.000 description 2
- 238000000926 separation method Methods 0.000 description 2
- 230000009772 tissue formation Effects 0.000 description 2
- 238000009966 trimming Methods 0.000 description 2
- 208000000094 Chronic Pain Diseases 0.000 description 1
- 208000002193 Pain Diseases 0.000 description 1
- 208000035965 Postoperative Complications Diseases 0.000 description 1
- 210000005022 abdominal esophagus Anatomy 0.000 description 1
- 210000003484 anatomy Anatomy 0.000 description 1
- 230000009286 beneficial effect Effects 0.000 description 1
- 238000010586 diagram Methods 0.000 description 1
- 238000005516 engineering process Methods 0.000 description 1
- 210000003238 esophagus Anatomy 0.000 description 1
- 239000007943 implant Substances 0.000 description 1
- 208000014674 injury Diseases 0.000 description 1
- 230000007774 longterm Effects 0.000 description 1
- 210000001370 mediastinum Anatomy 0.000 description 1
- 230000004048 modification Effects 0.000 description 1
- 238000012986 modification Methods 0.000 description 1
- 238000011084 recovery Methods 0.000 description 1
- 230000009467 reduction Effects 0.000 description 1
- 238000010561 standard procedure Methods 0.000 description 1
- 230000000638 stimulation Effects 0.000 description 1
- 210000002784 stomach Anatomy 0.000 description 1
- 239000000126 substance Substances 0.000 description 1
- 230000008733 trauma Effects 0.000 description 1
- 210000001186 vagus nerve Anatomy 0.000 description 1
- 210000001835 viscera Anatomy 0.000 description 1
Abstract
The invention relates to a multi-layer composite patch with a mesh edge sealing structure, and relates to the technical field of soft tissue repair materials. The multi-layer composite patch with the mesh edge sealing structure comprises a bioabsorbable film layer, a mesh layer and a bioabsorbable ring belt layer; the mesh layer is adhered to the upper surface of the absorbable film layer, the bioabsorbable annular layer is arranged above the mesh layer and completely covers the edge of the mesh layer, and the edge of the bioabsorbable film layer is bent and adhered to the edge of the bioabsorbable annular layer to cover the edge of the bioabsorbable annular layer. The multi-layer composite patch with the mesh edge sealing structure can wrap the alimentary canal from the alimentary canal hole or the alimentary canal groove to repair the junction defect/weakness of the alimentary canal and the abdominal cavity wall so as to achieve the treatment effect; the patch edge can be effectively protected from erosion of the patch to the digestive tract.
Description
Technical Field
The invention relates to the technical field of soft tissue repair materials, in particular to a multi-layer composite patch with a mesh edge sealing structure. In clinical applications, such patches may be used to repair and strengthen the digestive tract and abdominal cavity wall boundary defects/weaknesses in the abdominal cavity.
Background
Patch erosion (Mesh reduction or Mesh planning) is a potentially serious complication of a clinician performing a non-stretch hernia repair on a patient. Such postoperative complications are often manifested by chronic pain in the patient after surgery, with portions of the implant eroding into surrounding tissue or adjacent organ tissue at the implantation site.
The main reasons for the erosion of the patch are two, one is that the patch migrates and erodes due to insufficient fixation of the patch or external forces, and the other is that the patch migrates and erodes gradually along the anatomical surface after implantation.
From the experience of the clinician, the damage to the organ surface can be prevented to some extent by trimming the sharp edges of the patch and reducing the inflammatory response leading to erosion. Therefore, during operation, a proper patch should be selected, unnecessary trimming is reduced, and damage caused by friction between the edge of the patch and viscera is reduced as much as possible. However, when using tension-free hernia repair to repair and strengthen defects/weaknesses at the junction of the alimentary canal and the abdominal cavity wall, the resulting erosion of the patch is more direct than that caused by conventional tension-free hernia repair, because the relative position between the placement of the patch and the associated anatomy is different from that of conventional tension-free hernia repair. This is because in this case the alimentary tract is generally perpendicular to the patch direction, which gives a higher likelihood of near perpendicular contact of the patch edges. This is also a concern for clinicians in taking standard clinical techniques.
Disclosure of Invention
In order to solve the problems in the prior clinical technology, the invention aims to provide a multi-layer composite patch with a mesh edge sealing structure. The patch may provide closed protection to the entire patch edge, changing its potential contact with the digestive tract from a sharp contact to a blunt contact.
The multi-layer composite patch with the mesh edge sealing structure comprises a bioabsorbable film layer, a mesh layer and a bioabsorbable ring belt layer; the mesh layer is adhered to the upper surface of the absorbable film layer, the bioabsorbable annular layer is arranged above the mesh layer and completely covers the edge of the mesh layer, and the edge of the bioabsorbable film layer is bent and adhered to the edge of the bioabsorbable annular layer to cover the edge of the bioabsorbable annular layer.
Wherein the net sheet layer is provided with digestive tract holes, and the digestive tract holes are positioned at 1/2-3/4 of the length direction.
Wherein the mesh layer has an alimentary canal aperture and a lateral opening connecting the alimentary canal aperture.
The net sheet layer is provided with an alimentary canal groove, and the alimentary canal groove is positioned at 1/4-3/4 of the width direction.
Wherein the material of the bioabsorbable membrane layer and the bioabsorbable ring belt layer is a polylactide copolymer such as polypropylene-caprolactone, polypropylene-glycolide, and the like.
The bio-absorbable film layer and the bio-absorbable girdle layer are prepared through solution casting, solution pouring, hot pressing, electrostatic spinning and other processes.
Wherein the mesh layer is made of non-absorbable material and/or absorbable material.
Wherein the non-absorbable material is selected from polypropylene, polyvinylidene fluoride and/or polyester.
Wherein the absorbable material is selected from the group consisting of polyglycolide, polyglycolide and/or polydioxanone.
The mesh layer is prepared through warp knitting, 3D printing, compression molding, electrostatic spinning and other processes.
Compared with the prior art, the multi-layer composite patch with the mesh edge sealing structure has the following beneficial effects:
the multi-layer composite patch with the mesh edge sealing structure can wrap the alimentary canal from the alimentary canal hole or the alimentary canal groove to repair the junction defect/weakness of the alimentary canal and the abdominal cavity wall so as to achieve the treatment effect; the patch edge can be effectively protected from erosion of the patch to the digestive tract.
Drawings
FIG. 1 is a schematic view in partial cross-section of a multi-layer composite patch panel edge seal of the present invention;
FIG. 2 is a schematic hierarchical view of a multi-layer composite patch of the present invention;
FIG. 3 is a schematic structural view of a multi-layer composite patch with alimentary canal holes of example 1;
FIG. 4 is a schematic structural view of a multi-layer composite patch with an alimentary canal orifice and an arcuate head of example 2;
FIG. 5 is a schematic structural view of a multi-layer composite patch with digestive tract grooves according to example 3;
fig. 6 is a schematic view of the edge of a multi-layer composite patch in which the present invention is actually used.
FIG. 7 is a schematic view of a conventional patch edge (not including a bioabsorbable belt layer) using the prior art;
fig. 8 is a margin pathology section of an implanted animal using the multi-layered composite patch of the present invention.
Fig. 9 is a section of an edge pathology in an animal re-implanted using a conventional patch of the prior art.
Detailed Description
The multi-layer composite patch with mesh edge seal structure of the present invention will be further described below with reference to specific examples to aid one skilled in the art in a more complete, accurate and thorough understanding of the present invention.
The invention relates to a multi-layer composite patch with a mesh edge sealing structure, which is characterized in that a bioabsorbable material is adopted to thoroughly cover and protect the edge of the patch so as to reduce the stimulation of the edge of the patch to the tissues of the digestive tract or the abdominal cavity wall and reduce the possibility of patch erosion. The edge sealing position comprises a bioabsorbable film layer 1, a net sheet layer 2 adhered on the absorbable film layer, and a bioabsorbable ring belt layer 3 for edge protection, and the partial cross-section schematic diagram of the net sheet edge sealing position is shown in fig. 1. As shown in fig. 2, the multi-layer composite patch itself comprises a layer of bioabsorbable film 4, a mesh layer 5 adhered over the absorbable film layer, and a layer of bioabsorbable tape layer 6 for edge protection.
Example 1
As shown in fig. 3, the structure of the multi-layer composite patch according to the present embodiment conforms to the multi-layer structure of the bioabsorbable membrane layer 7, the mesh layer 8, and the bioabsorbable belt layer 9. The mesh layer is added with digestive tract holes 8-1 for the digestive tract to pass through. In application, the outer surface of the bioabsorbable membrane layer is placed facing the abdominal cavity, the outer surface of the non-absorbable layer is placed facing the abdominal cavity wall, and the digestive tract can be connected with the abdominal cavity wall through the digestive tract hole. In this example, polypropylene-caprolactone was used for the bioabsorbable membrane layer and the bioabsorbable ring belt layer. The polypropylene-caprolactone has good biocompatibility and degradability, can effectively reduce the risk of adhesion between the patch and organs in the abdominal cavity or the formation of extra scar tissues at the initial stage of implantation, is slowly degraded and absorbed after the tissue grows in, and finally is metabolized into carbon dioxide and water to be discharged out of the body. In this example, polypropylene is used for the mesh layer. Polypropylene is a non-absorbable synthetic polymer, and can stimulate tissues to quickly induce scar tissue formation so as to achieve the purpose of repairing and reinforcing tissues around the digestive tract. In addition, in order to improve the biocompatibility of polypropylene, the mesh layer may be immersed in a polypropylene-caprolactone solution, the surface thereof is coated, and then the surface is dried, so that the treated mesh layer can obtain better biocompatibility.
Example 2
As shown in fig. 4, the multi-layer composite patch structure of the present embodiment conforms to the multi-layer structure of the bioabsorbable membrane layer 10, the mesh layer 11, and the bioabsorbable belt layer 12. The mesh layer is added with digestive tract holes 11-1 for the digestive tract to pass through. When the patch is applied, the outer surface of the bioabsorbable membrane layer is placed facing the abdominal cavity, the outer surface of the non-absorbable layer is placed facing the abdominal cavity wall, the alimentary canal can enter the alimentary canal hole through the lateral opening 11-2, and the fixed tail fin 11-3 formed at the lateral opening of the mesh layer can be used for fixing the patch by an operator. And the patch contains an arcuate head 11-4. In this example, polypropylene-glycolide was used for the bioabsorbable membrane layer and the bioabsorbable belt layer. The polypropylene-glycolide has good biocompatibility and degradability, can effectively reduce the risk of adhesion between the patch and organs in the abdominal cavity or the formation of extra scar tissues at the initial stage of implantation, is slowly degraded and absorbed after the tissue grows in, and finally is metabolized into carbon dioxide and water to be discharged out of the body. In this example, polypropylene and polyglycolide-caprolactone are used for the mesh layer. Polypropylene is a non-absorbable synthetic polymer, and can stimulate tissues to quickly induce scar tissue formation so as to achieve the purpose of repairing and reinforcing tissues around the digestive tract. Polyglycolide-caprolactone is an absorbable synthetic polymer which provides mechanical strength to maintain the operating hand of the physician at the beginning of implantation, but is degraded and absorbed after the tissue is grown in, and finally metabolized to carbon dioxide and water to be expelled from the body.
Example 3
As shown in fig. 5, the multi-layer composite patch structure of the present embodiment conforms to the multi-layer structure of the bioabsorbable membrane layer 13, the mesh layer 14, and the bioabsorbable tape layer 15. The mesh layer is added with an alimentary canal groove 14-1 for the alimentary canal to pass through. When the patch is applied, the outer surface of the bioabsorbable membrane layer is placed facing the abdominal cavity, the outer surface of the non-absorbable layer is placed facing the abdominal cavity wall, the digestive tract can pass through the digestive tract groove and is placed at the bottom 14-2 of the digestive tract groove, and the fixed tail 14-3 formed at the notch of the digestive tract groove of the mesh layer can be used for fixing the patch by an operator. In this example, polypropylene-caprolactone was used for the bioabsorbable membrane layer and the bioabsorbable ring belt layer. The polypropylene-caprolactone has good biocompatibility and degradability, can effectively reduce the risk of adhesion between the patch and organs in the abdominal cavity or the formation of extra scar tissues at the initial stage of implantation, is slowly degraded and absorbed after the tissue grows in, and finally is metabolized into carbon dioxide and water to be discharged out of the body. In this example, polyvinylidene fluoride was used for the mesh layer. Polyvinylidene fluoride is a non-absorbable synthetic polymer, has stable physical and chemical properties, and has good long-term biocompatibility and biostability.
The multilayer composite patch of example 1 is typically used in a standard surgical procedure for parastomal hernias, which is typically performed by a surgeon with corresponding clinical experience, and common surgical procedures are Keyhole and sugarboker. With laparoscopic surgical applications, ostomy procedures typically include: 1) Establishing pneumoperitoneum, confirming the defect position under a laparoscope, judging the defect size, and entering the stomas by hernia contents and hernia contents. 2) The intra-abdominal and parastomal hernia sac adhesion was loosened. 3) The suture closes the dead space and the defect. 4) The alimentary canal is passed through the central aperture of the multi-layered composite patch with the non-absorbable layer of the multi-layered composite patch facing the abdominal cavity wall and the bioabsorbable membrane layer facing into the abdominal cavity, which is then prescribed on the abdominal cavity wall with sutures, fasteners, medical glue. 5) If the separation wound surface is larger in the operation, a drainage tube is required to be placed in the hernia sac so as to prevent infection caused by effusion. Closing the puncture.
The multi-layer composite patches described in examples 2 and 3 are typically used in the standard surgical procedure of laparoscopic hiatal hernia repair, which is typically performed by a surgeon with corresponding clinical experience, and has the advantages of small trauma, rapid recovery, positive anti-reflux effect, few complications, etc. Standard procedures for surgery generally include: 1) Establishing pneumoperitoneum, confirming the defect position under a laparoscope, judging the defect size, and entering the mediastinum by hernia contents. 2) The hernia contents are returned to the abdominal cavity and the hernial sac is separated from the contents (if any) and care should be taken to protect the vagus nerve at the esophagus during this procedure. 3) Lifting the abdominal esophagus to expose the defect part. The non-absorbable layer of the multi-layer composite patch special for hiatal hernia is oriented to the diaphragm, the bioabsorbable film layer is oriented to the stomach, and then the suture, the fixer and the medical glue are used for fixing the patch on the diaphragm. 4) If the separation wound surface is larger in the operation, a drainage tube is required to be placed in the hernia sac so as to prevent infection caused by effusion. 5) According to the actual condition of the patient, the anti-reflux operation can be properly performed.
As shown in fig. 6, for a multi-layer composite patch employing the present invention, the edges thereof may be covered by their bioabsorbable belt layers and form a blunt contact surface. Such contact surfaces, after implantation in a living being, develop a lower inflammatory response to the surrounding tissue at their edges, as shown in fig. 8. As shown in fig. 7, for a conventional patch that does not employ a bio-absorbable annular layer, the edges thereof are not covered by the bio-absorbable annular layer and present a sharp serrated contact surface. Such contact surfaces, after implantation in a living body, develop a high inflammatory response to the surrounding tissue at their edges, as shown in fig. 9.
It will be apparent to those skilled in the art that the present invention has been described by way of example only, and that the invention is not limited by the above embodiments, and that various insubstantial modifications, either as contemplated by the method and the solution of the invention, or as otherwise would be apparent to one of ordinary skill in the art, are within the scope of the invention.
Claims (10)
1. A multilayer composite patch with net piece banding structure which characterized in that: the multi-layer composite patch comprises a bioabsorbable film layer, a mesh layer and a bioabsorbable ring belt layer; the mesh layer is adhered to the upper surface of the absorbable film layer, the bioabsorbable annular layer is arranged above the mesh layer and completely covers the edge of the mesh layer, and the edge of the bioabsorbable film layer is bent and adhered to the edge of the bioabsorbable annular layer to cover the edge of the bioabsorbable annular layer.
2. The multi-layer composite patch with mesh edge seal structure of claim 1, wherein: the net sheet layer is provided with digestive tract holes, and the digestive tract holes are positioned at 1/2-3/4 of the length direction.
3. The multi-layer composite patch with mesh edge seal structure of claim 1, wherein: the mesh layer has an alimentary canal aperture and a lateral opening connecting the alimentary canal aperture.
4. The multi-layer composite patch with mesh edge seal structure of claim 1, wherein: the net sheet layer is provided with an alimentary canal groove, and the alimentary canal groove is positioned at 1/4-3/4 of the width direction.
5. The multi-layer composite patch with mesh panel edge seal structure of any one of claims 1-4, wherein: the material of the bioabsorbable membrane layer and the bioabsorbable annular belt layer is polylactide copolymer.
6. The multi-layer composite patch with mesh edge seal structure of claim 5, wherein: the bioabsorbable membrane layer and the bioabsorbable annular layer are prepared by solution casting, solution pouring, hot pressing or electrostatic spinning.
7. The multi-layer composite patch with mesh panel edge seal structure of any one of claims 1-4, wherein: the mesh layer is made of non-absorbable material and/or absorbable material.
8. The multi-layer composite patch with mesh edge seal structure of claim 7, wherein: the non-absorbable material is selected from polypropylene, polyvinylidene fluoride and/or polyester.
9. The multi-layer composite patch with mesh edge seal structure of claim 7, wherein: the absorbable material is selected from the group consisting of polyglycolide-caprolactone, polyglycolide and/or polydioxanone.
10. The multi-layer composite patch with mesh edge seal structure of claim 7, wherein: the mesh layer is prepared by warp knitting, 3D printing, compression molding or electrostatic spinning.
Priority Applications (1)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| CN202311474300.9A CN117482286A (en) | 2023-11-08 | 2023-11-08 | Multilayer composite patch with net piece banding structure |
Applications Claiming Priority (1)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| CN202311474300.9A CN117482286A (en) | 2023-11-08 | 2023-11-08 | Multilayer composite patch with net piece banding structure |
Publications (1)
| Publication Number | Publication Date |
|---|---|
| CN117482286A true CN117482286A (en) | 2024-02-02 |
Family
ID=89673962
Family Applications (1)
| Application Number | Title | Priority Date | Filing Date |
|---|---|---|---|
| CN202311474300.9A Pending CN117482286A (en) | 2023-11-08 | 2023-11-08 | Multilayer composite patch with net piece banding structure |
Country Status (1)
| Country | Link |
|---|---|
| CN (1) | CN117482286A (en) |
-
2023
- 2023-11-08 CN CN202311474300.9A patent/CN117482286A/en active Pending
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