A kind of can effectively preventing is shifted, reduces the degradable human body support of hypertrophy and manufacture method
Technical field
The present invention relates to a kind of degradable human body support and preparation method thereof of the hypertrophy that can effectively prevent from being shifted, reducing, especially its distinctive film mulching method and fixed knot.
Background technology
Esophagus is optimum, malignant stricture is that digestive endoscopy doctor needs one of significant clinical problem solved.Optimum and the malignant stricture for esophagus, Therapeutic Method conventional at present comprises esophagostenosis expansion or esophageal stenting.In the treatment of esophagostenosis, conventional support is Nitinol self-inflated metal rack (self-expanding stent, SES).But metal rack is a kind of foreign body for human body, the long-term SES of placement treats Benign esophageal stenosis, can cause the hyperplasia of Esophageal Mucosa, cause patient's dysphagia to increase the weight of even to cause the complication such as perforation; Need second operation to take out after playing therapeutical effect simultaneously, this adds increased the misery of patient, Operative risk and medical expense.
Along with the further investigation to degradation material, have developed some and compare the degradation material being suitable for preparing support, as PPDO (PDO), polylactic acid (PLA), polycaprolactone, polyglycolic acid, polylcaprolactone, polyhydroxybutyrate valerate, Polyethylene Glycol, degradable polyurethane are that the degradation material ratio of representative is more suitable for establishment biodegradable Esophageal Stent.Degradation material is in vivo once degraded, and its supporting role declines gradually, and namely certain hour is degraded complete and excreted.Do not need scope intervention again after inserting, there is wide potential applicability in clinical practice.But the clinical report after the biodegradable Esophageal Stent implantation of clinical only useful PPDO entirety establishment at present, and complication is more serious, Benign esophageal stenosis is made in of short duration expansion, subsequently due to stimulate cause Esophageal Mucosa hyperplasia, even cause restenosis, simultaneously the ratio of stent migration is quite high.The high-strength mechanical that the preparation method of this side effect and biodegradable Esophageal Stent and its structure cause stimulates closely related.
Therefore, if can provide one safer, whether at the bottom of hypertrophy, inflammatory reaction and displacement rate, do not need to take out again, and/or can the human body support of storing state such as to be shifted by Fast Identification at radiography, will be a very valuable thing.
Summary of the invention
The object of the present invention comprises provides a kind of can effectively preventing to be shifted, to reduce the degradable human body alimentary canal support of hypertrophy and manufacture method, this support comprises the stagewise mesh structure flexibly connected, the film mulching method of skirt stacked, and for support bracket fastened special fixed-node.
Technical scheme of the present invention is as follows:
Effectively can prevent displacement, reduce a degradable human body alimentary canal support for hypertrophy, comprise:
---mesh structure, this mesh structure is made up of multistage time reticulate body, be connected in series between this multistage time reticulate body, make this multistage time reticulate body under stressed, to a certain degree bend relative to each other, and a passage is formed between this multistage time reticulate body, this multistage time reticulate body is made up of degradable material;
---skirt stacked degradable overlay film, film material is coated on the outer surface of each segmentation, and covering material is degradation material;
---at least one developing mark, is attached on this multistage time reticulate body, identifies the implantation position of this medical-therapeutic treatment of human body support at human body in order to provide during human body radiography.
Described mesh structure two outside time reticulate body compared with inner side, there is larger caliber; Described skirt stacked degradable overlay film is positioned at support two end portions and exceeds the described degradable human body alimentary canal rack body 5-10mm that effectively can prevent displacement, reduce hypertrophy, in making shirt rim shape, for preventing hypertrophy.
Medical-therapeutic treatment of human body support is used for support human body digestion tract, and to avoid subsiding, the passage in this multistage time reticulate body keeps solid, liquid or gas to lead to opposite side by the side of this degradable medical-therapeutic treatment of human body support smoothly.
Multiple described mesh structure is made up of degradable macromolecule material.
Multiple described mesh structure carries out the series connection structure body be connected in series, and is made up of the degradable material identical or different with multiple described mesh structure.
Described developing mark is a metal material or this developing mark is a non-metallic material.
Effectively can prevent displacement, reduce the degradable human body alimentary canal support of hypertrophy, it is characterized in that described developing mark has multiple, and be socketed in the diverse location of multiple described mesh structure respectively.
Multiple described mesh structure is worked out by a rhizoid material, or multiple described mesh structure is worked out by more than two silk materials.
The invention provides another kind effectively to prevent displacement, reduce the degradable human body alimentary canal support of hypertrophy, comprise:
Multistage time mesh structure, is made up of degradable material; And
Series connection structure body, is connected in series by this series connection structure body between this multistage time reticulate body, and make this multistage time reticulate body under stressed, other reticulate body to a certain degree bends relatively, and forms a passage between this multistage time reticulate body.
Described human body alimentary canal support more comprises a coating film, is coated on this multistage time netted body peripheral; More comprise at least one developing mark, be attached on this multistage time mesh structure, identify the implantation position of this medical-therapeutic treatment of human body support at human body in order to provide during human body radiography.
Described mesh structure two outside time reticulate body compared with inner side, there is larger caliber; Described skirt stacked degradable overlay film is positioned at support two end portions and exceeds the described degradable human body alimentary canal rack body 5-10mm that effectively can prevent displacement, reduce hypertrophy, in making shirt rim shape, for preventing hypertrophy.
Described can effectively preventing being shifted, reducing the degradable human body alimentary canal support of hypertrophy for supporting esophagus, biliary tract, urethra, trachea or body cavities, to avoid subsiding, the passage in this multistage time reticulate body keeps solid, liquid or gas to lead to opposite side by the side of this degradable medical-therapeutic treatment of human body support smoothly.
Described the plurality of mesh structure is made up of degradable macromolecule material.
This multistage described time mesh structure carries out the series connection structure body be connected in series, and is made up of the degradable material identical or different with this multistage time reticulate body.
This developing mark described is a metal material or this developing mark described is a non-metallic material, and this developing mark described has multiple, and is socketed in the diverse location of this multistage time mesh structure respectively.
Described multistage time mesh structure is worked out by a rhizoid material or described multistage time mesh structure is worked out by more than two silk materials.
The present invention also provides a kind of manufacture method of degradable medical-therapeutic treatment of human body support, comprises following steps:
Become multiple reticulate bodies with a degradable material wire rod weaving, be connected in series with series connection structure body between the plurality of reticulate body, make the plurality of reticulate body can carry out certain bending to each other when stressed; Utilize a coating film, coated the plurality of reticulate body, this bag membrane is degradable material.
More comprise following steps:
By at least one developing mark, be attached on this multistage time reticulate body, identify the implantation position of this medical-therapeutic treatment of human body support at human body in order to provide during human body radiography.
The invention has the beneficial effects as follows:
1. after balloon expandable, reach working diameter inserting after in body, expand moulding after not easily bounce back, the establishment of mariages structure effectively prevents support from degradation process, occurring subsiding of supporting structure;
2. the segment design of this type biodegradable stent can make support play supporting role at esophagostenosis position, simultaneously each intersegmental can freely-movable relatively, due to the existence of skirt stacked film material, at utmost reduce the long stimulus effect to the non-narrow positions of esophagus, avoid because biodegradable stent main body continues the hyperplasia phenomenon stimulating Esophageal Mucosa to cause;
3. this type biodegradable stent has polylactic acid to surpass the full structure of film of mouth, effectively prevents Esophageal Mucosa hypertrophy granulation tissue Esophageal Stent mesh of growing into inner, forms support tube intracavity narrow;
4. because special pimple surplus exists, and segmental structure one end compressive deformation, all the other grid sections normal expansion, support is not easily shifted.
5, the mesh structure of degradable human body alimentary canal support of the present invention is made up of multistage time reticulate body, flexible linking is carried out between multistage time reticulate body, make multistage time reticulate body under stressed, a certain section of dictyosome is stressed, next segmentation dictyosome can't be delivered to, reduce the frequency that integral support is stressed, reduce stent migration ratio.Owing to flexibly connecting between dictyosome, can relatively to a certain degree bend to each other, support entirety can unstressedly bend, and better complies with body cavities physiological structure; When the peristalsis effect that digestion tract multifrequency is secondary, support entirety can reduce wriggling wave amplitude, absorption portion wriggling ability, thus slows down the mechanical stimulus to body cavities, extenuates hypertrophy complication; Especially the stimulus intensity of rim of a cup end and the frequency can significantly decline, and rim of a cup hyperplasia degree can reduce a lot;
6, degradable human body alimentary canal support of the present invention mesh structure two outside time reticulate body compared with inner side, there is larger caliber, can be horn body, cup-shaped, spherical, mushroom-shaped structure, or other amplify body in proper order; Larger expansion equivalent can be produced in end, to avoid tract inter collapse, by the passage in multistage time reticulate body, keep solid, liquid or gas to lead to opposite side by the side of medical-therapeutic treatment of human body support smoothly.Support two ends step is stressed comparatively strong simultaneously, and large rim of a cup effectively can prevent stent migration, fixing human support; Here the multistage mentioned refers to more than two sections and two sections.Multiple times netted body support frame is made up of degradable macromolecule material, as lactic acid and modification thereof without, polyurethane, polyglycolic acid (polyglycolicacid, PGA), polycaprolactone (polycaprolactone, or PPDO (Poly-p-dioxanone PCL), PPDO) etc., or be individually the preparation of non-degradable material, or both mixing compositions.Degradable material as: as PPDO (PPDO), polylactic acid (PLA), polycaprolactone, polyglycolic acid, polylcaprolactone, polyhydroxybutyrate valerate, Polyethylene Glycol, degradable polyurethane etc.;
7, the overlay film of the multistage time netted body support frame group stacked of degradable human body alimentary canal support of the present invention, skirt stacked degradable film mulching method is that multistage time reticulate body relative motion provides space, can not limit, affect the displacement of multistage time reticulate body, bending, wriggling etc.; Overlay film has completely cut off scaffolding thread material and has contacted with the direct of digestive tract inwall, as tissue fluid, mucus etc., and available protecting degradable silk material, extend the degradation time of support, within treatment time, make support can support tract fully narrow, can not be too fast because of degraded, cause too early subsiding; In addition, change bare bracket and the linear contact lay pattern of digestion orifice bracket support, become face contact mode, effectively extenuate stimulus intensity, wire side film material can stop granulation prevention to develop to support intracavity simultaneously; Also stifled fistula can be carried out, as esophago-tracheal fistula; This film material can be that degradable material or non-degradable material are formed, as polylactic acid and modification body film material, PTFE film material;
8, degradable human body alimentary canal support of the present invention with special fixed-node, support can be made closely chimeric with digestive tract inwall, the heavy outpost of the tax office is set in the digestive tract section of implant frame, effectively prevents stent migration.In order to extenuate the stimulation of node to digestion inwall, material surface for the preparation of node can carry antiinflammatory microgranule medicine, this node can prepare (must have good biocompatibility) by the non-metallic material of band developing function in addition, so both can play support bracket fastened effect, meet the function of development simultaneously, stenter to implant ready position can be shown;
9, one or more developing mark, symmetry is attached on multistage time reticulate body circumference, identifies the implantation position of this medical-therapeutic treatment of human body support at human body in order to provide during human body radiography.Developing mark is for can be metal material, and the metal of preferably human body not responsiveness, such as gold, platinum, tantalum or other various Metal and Alloy materials are formed.The polymer that also can have developing function for other, developing mark also can be non-metallic material, as long as it can reflect its position when human body radiography.Developing mark more than two, and can be socketed in the diverse location of the plurality of reticulate body respectively;
By these medical-therapeutic treatment of human body support and manufacture method, instrument more easily can be provided medically, can inflammatory reaction be reduced, and can not need to remove support by second time operation, what support also can be more reliable maintain should position.
Accompanying drawing explanation
Fig. 1 is a kind of structural representation of the degradable human body alimentary canal support according to the embodiment of the present invention.
Fig. 2 is the axial front view of Fig. 1 degradable human body alimentary canal support.
Fig. 3 is the structural representation of reticulate body in degradable human body alimentary canal support.
Fig. 4 is the structural representation of one of situation when mesh structure bends in degradable human body alimentary canal support.
The structural representation of one of situation when Fig. 5 is mesh structure compression in degradable human body alimentary canal support.
Fig. 6 is the degradation process schematic diagram of degradable Esophageal Stent in bar horse pig body of the embodiment of the present application.
concrete embodiment
Below in conjunction with embodiment, the present invention will be further described, but the present invention is never limited to following embodiment.
Please refer to Fig. 1 and Fig. 2, wherein Fig. 1 is side view, and Fig. 2 is front view.
Fig. 1 illustrates a kind of degradable medical-therapeutic treatment of human body support with Fig. 2, comprises mesh structure, coating film and developing mark: the first developing mark 131, second developing mark 132, the 3rd developing mark 133 and the 4th developing mark 134.Mesh structure is by multistage time reticulate body: first paragraph time reticulate body 111, second segment time reticulate body 112, 3rd section reticulate body 113, 4th section reticulate body 114 and the 5th section reticulate body 115 form, multistage time reticulate body comprises: first paragraph time reticulate body 111, second segment time reticulate body 112, 3rd section reticulate body 113, flexible wire 151 is had to be connected in series between the 4th section reticulate body 114 and the 5th section reticulate body 115, this connection can connect for simple smooth, also other mode can be adopted, multistage time reticulate body is under stressed, to a certain degree bend relative to each other.At multistage time reticulate body: first paragraph time reticulate body 111, second segment time reticulate body 112, the 3rd section reticulate body 113, form a passage between the 4th section reticulate body 114 and the 5th section reticulate body 115.Although illustrated time reticulate body is five sections, also can be two sections or other various probabilities, and each reticulate body can have same diameter and length, also according to the body cavities that will implant, different stent diameters, length can be designed.
Skirt stacked degradable overlay film: the first skirt stacked degradable overlay film 211, second skirt stacked degradable overlay film the 212, the 3rd skirt stacked degradable overlay film the 213, the 4th skirt stacked degradable overlay film 214 and the 5th skirt stacked degradable overlay film 215 are overlying on multistage time reticulate body in the mode that skirt is folded: first paragraph time reticulate body 111, second segment time reticulate body 112, the 3rd section reticulate body 113, the 4th section reticulate body 114 and the 5th section reticulate body 115 surface, its one end is fixed, and the other end is overlying on the surface of next section of reticulate body film material; The first series connection structure body 141 that cladding process uses includes but not limited to suture body, dipping, electrostatic spinning etc.Can comprise multiple similar or be same as the series connection structure body of the first series connection structure body 141.
Both can carry out shutoff for tract fistula by skirt stacked degradable overlay film, and as esophago-tracheal fistula, to avoid such as esophagus, trachea object, air to move improperly via leak generation, the freely-movable of every section of merogenesis can not be limited again, thus extenuate stimulation.The cladding process of skirt stacked degradable overlay film is not limited to sew up, flood and electrostatic spinning.
Multiple developing mark comprises: the first developing mark 131, second developing mark 132, the 3rd developing mark 133 and the 4th developing mark 134 are attached on the works of one or more snippets reticulate body, identifies the implantation position of this medical-therapeutic treatment of human body support at human body in order to provide during human body radiography.
Special fixed knot 13 invests multistage time reticulate body: first paragraph time reticulate body 111, second segment time reticulate body 112, the 3rd section reticulate body 113, the 4th section reticulate body 114 and the 5th section reticulate body 115 surface, play support bracket fastened effect, the risk reducing stent migration or come off; If special fixed knot material has developability in addition, can use as developing mark, thus not need special the first developing mark 131, second developing mark 132, the 3rd developing mark 133 and the 4th developing mark 134.
Fig. 3 illustrates the first state of network structure body 11.Fig. 4 to illustrate in network structure body 11 between multiple time netted structures after by certain strength, carries out the state of angle of bend to each other.Deformation when Fig. 5 illustrates that network structure body 11 is extruded.In this example, although network structure body is using rhombus as explanation, actual fabrication can replace to other geometries various.
Mesh structure, coating film are made up of various high molecular degradable material.The macromolecule material of reticulate body includes but not limited to polylactic acid, Merlon, a poly-caprolactone, gelatin, Polyethylene Glycol or a kind of and multiple combination, can be: Biopolvester, biology cellulose, polysaccharide and polyamino acid etc., as polylactic acid and modifier (poly-L-lactic acid thereof, PLA), polyglycolic acid (polyglycolicacid, PGA), polycaprolactone (polycaprolactone, or PPDO (Poly-p-dioxanone, PPDO) PCL).
The material of coating film can be applicable degradable material, such as but not limited to, pellosil, PTFE film etc., can be such as lactic acid and modification thereof without, polyurethane, polyglycolic acid (polyglycolicacid, PGA), polycaprolactone (polycaprolactone, or PPDO (Poly-p-dioxanone PCL), PPDO) etc., Biopolvester, biology cellulose, polysaccharide and polyamino acid etc., as polylactic acid and modifier (poly-L-lactic acid thereof, PLA), polyglycolic acid (polyglycolicacid, PGA), polycaprolactone (polycaprolactone, PCL), PPDO (Poly-p-dioxanone, PPDO), polylactic acid and modification thereof without, polyurethane, polyglycolic acid (polyglycolicacid, PGA), polycaprolactone (polycaprolactone, PCL), PPDO (Poly-p-dioxanone, PPDO) etc.Actual material can carry out suitable adjustment according to the human body that will implant.
Except the human body support of Fig. 1 to Fig. 5 demonstration, skirt superimposition film, special node or developing mark can need to make trade-offs according to difference.Such as can make the network structure body not needing coating film, or not need the network structure body of developing mark, all belong to scope of the present invention.
In addition, multistage time reticulate body: first paragraph time reticulate body 111, second segment time reticulate body 112, the 3rd section reticulate body 113, the first serial connection series connection structure body 141 of carrying out between the 4th section reticulate body 114 and the 5th section reticulate body 115 being connected in series, by with the identical degradable material composition of this multistage time reticulate body, also can make by different materials as required.
A concrete embodiment of the present invention is as follows:
A kind of Biodegradable scaffold, the polylactic acid biological skirt stacked degradable overlay film comprising the rack body of Biodegradable material PPDO segmentation establishment, rim of a cup and cut.
Described Biodegradable scaffold main unit and the bifilar silk establishment of rim of a cup unit USP1 PPDO silk, linkage unit USP0 PPDO silk sub-thread silk is worked out.
Described Biodegradable scaffold main body adopts segmentation establishment, is linkage unit between each section; It is linkage unit between rim of a cup unit and main unit.
The every segment length 10mm of described Biodegradable scaffold main unit, linkage unit length 4mm..
Described Biodegradable scaffold two ends are rim of a cup shape, length 10mm, and diameter comparatively main part expands 6mm.
The each section surface of described Biodegradable scaffold covers polylactic acid membrane, and integral support film material is skirt stacked, and film material surpasses mouth overlay film length 5mm.; Described skirt stacked degradable overlay film is positioned at support two end portions and exceeds the described degradable human body alimentary canal rack body 5-10mm that effectively can prevent displacement, reduce hypertrophy, in making shirt rim shape, for preventing hypertrophy.
At support rim of a cup edge near interlude, adopt each symmetry of USP2# PPDO silk to make a call to 4 each special fixing pimple knots, interlude makes a call to 4 pimple knots.
The present invention also provides a kind of method making degradable medical-therapeutic treatment of human body support, comprises:
Become multiple reticulate bodies with a degradable material wire rod weaving, be connected in series with series connection structure body between the plurality of reticulate body, make the plurality of reticulate body can carry out certain bending to each other when stressed;
Utilize a coating film, coated the plurality of reticulate body, this bag membrane is degradable material.
More comprise:
By at least one developing mark, be attached on this multistage time reticulate body, identify the implantation position of this medical-therapeutic treatment of human body support at human body in order to provide during human body radiography.
Fig. 6 is the degradation process of degradable Esophageal Stent in bar horse pig body of the embodiment of the present application
As shown in Figure 6: the embodiment of the present application stagewise support is inserted after in bar horse pig body and occurred without stent migration, totally 10 stages, for convenience of explanation, according to from left to right, top-down order, be labeled as W1 to W5 successively, W6-W10, namely the degraded occurring timbering material PPDO (PPDO) is started in the W2 stage, the obvious degradation of timbering material PPDO (PPDO) is there is in the W4 stage, there is the fracture of timbering material PPDO (PPDO) in the W6 stage, the W7 stage occurs that the sheet of supporting structure comes off, W8 stage support is degradable, support is inserted after in bar horse pig body, does not occur that Esophageal Mucosa is hemorrhage, bores a hole and ulcer, the mucosa hyperplasia that timbering material PPDO (PPDO) causes is reversible mucosa reaction, the obvious mucosa hypertrophy of esophageal tissue is there is in the W2 stage, the W2 stage peaks, along with the degraded of timbering material, Esophageal Mucosa hyperplasia degree alleviates gradually, mainly be positioned at the position that timbering material PPDO (PPDO) is fitted with Esophageal Mucosa, after support is degradable, mucosa hypertrophy is not obvious, the position mucosa of W9 stage placing rack remains a little white scar, and W10 stage support disappears substantially.
The above is only the preferred implementation of the application, those skilled in the art is understood or realizes the invention of the application.Multiple amendment for these embodiments will be apparent for a person skilled in the art, and General Principle as defined herein when not departing from the spirit or scope of the application, can realize in other embodiments.Therefore, the application can not be limited in these embodiments shown in this article, but will meet the widest scope consistent with principle disclosed herein and features of novelty.