CN104905890A - Novel degradable stopper implanted through guide pipe and conveying system of novel degradable stopper - Google Patents
Novel degradable stopper implanted through guide pipe and conveying system of novel degradable stopper Download PDFInfo
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- CN104905890A CN104905890A CN201410094207.XA CN201410094207A CN104905890A CN 104905890 A CN104905890 A CN 104905890A CN 201410094207 A CN201410094207 A CN 201410094207A CN 104905890 A CN104905890 A CN 104905890A
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- stopper
- sacculus
- support bar
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Abstract
The invention provides a novel degradable stopper implanted through a guide pipe. The novel degradable stopper comprises a ball bag, a supporting rod and degrading liquid. The supporting rod is fixedly connected with the ball bag, the periphery of the supporting rod is wrapped by the ball bag, and the degrading liquid is a biological material which can be degraded and absorbed and is arranged in the ball bag in a filling mode to play a supporting effect. The invention further provides a conveying system of the novel degradable stopper implanted through the guide pipe. The conveying system comprises a long sheath, an inner core, a loader, a pushing rod and an infusion pipe. The stopper is made of degradable materials, foreign objects are not left in vivo, and a long-term effect is obvious. In addition, the stopper is of a ball bag type structure, and the inner filler of the stopper is temperature-sensitive hydrogel. When an abnormal defect is blocked, the stopper can be attached to the periphery of the defect completely, and especially a better blocking effect is achieved on irregular defects. The stopper can be suitable for blocking of the patent ductus arteriosus and can be made into a stopper suitable for atrial septal defects and a stopper suitable for ventricular septal defects through changing of the shape of the ball bag.
Description
Technical field
The present invention relates to a kind of stopper and induction system thereof, particularly a kind of novel degradable stopper through conduit implantation and induction system thereof.
Background technology
Congenital heart disease (congenital heart disease) is one of common cardiovascular disease, and its sickness rate is 8 ‰-12 ‰.Suffer from various congenital heart disease in the neonate that China is born every year and about have 150,000-20 ten thousand.Patent ductus arteriosus (PDA) is congenital heart disease common clinically, the cardiopathic 9%-12% of nature of taking the lead, traditional Therapeutic Method is surgical operation, but surgical operation is larger to body injury, there is certain postoperative complication and leave cicatrix, affecting the physical and mental health of patient.From the eighties in 20th century, China progressively introduces Wicresoft's interventional technique treatment congenital heart disease, because it has, safety is good, easy and simple to handle, controllability strong, the advantage of few intercurrent disease, particularly the succeeding in developing of domestic NiTi alloys occluder, the interventional therapy method of congenital heart disease is made to promote rapidly with universal in China, and along with treating the prolongation of number of cases increase and follow up time, its advantage manifests gradually.Though the Therapeutic Method being implanted first heart stopper by Minimally Invasive Surgery has many advantages relative to traditional surgery, but the timbering material of the first heart stopper of Clinical practice is nickel-titanium alloy material now, but still there are some application risks: 1, Nitinol is nondegradable metal alloy compositions, although its biocompatibility obtains checking, the long-term long term risk implanted still cannot be controlled.2, due to Nitinol Permanent implantation and non-degradable, its heart that may affect undeveloped mature is grown up.The complication such as 3, nickel ion is separated out, nickel is irritated do not have clear and definite scientific appraisal yet.Therefore, while popularization Wicresoft interventional method treatment congenital heart disease, research and develop and seem particularly important at the first heart stopper that late result is better, risk is less of Clinical practice.
Summary of the invention
The object of this invention is to provide a kind of novel degradable stopper through conduit implantation and induction system thereof, solve the various potential risk sex chromosome mosaicism that traditional NiTi alloys occluder exists.
In order to achieve the above object, the present invention is achieved by the following technical solutions:
The invention provides a kind of novel degradable stopper implanted through conduit, comprise sacculus, support bar and degradation solution, support bar is fixedly connected with sacculus, and sacculus is wrapped in the periphery of support bar, degradation solution is can the biomaterial of degraded and absorbed, is filled in balloon interior to play a supporting role.
Further improvement of the present invention is: support bar near-end is provided with female thread, is provided with isolating membrane in female thread, and female thread is depressed in balloon center place.
Further improvement of the present invention is: support bar is the single lumen catheter be made up of degradation material, and the far-end of support bar is hemispherical, and is depressed in balloon center place.
Further improvement of the present invention is: the far-end of sacculus one end and support bar is connected by welding manner and is hemispherical, and the other end is welded in the near-end female thread place of support bar.
Further improvement of the present invention is: sacculus be degradation material polylactic acid through Mould Machining obtained by molding, balloon distal diameter 3 ~ 5mm larger than waist diameter, length of balloon 7 ~ 10mm, is made into different size according to waist diameter.
Further improvement of the present invention is: be provided with several circular holes in the middle part of support bar.
Further improvement of the present invention is: sacculus and support bar all adopt poly-lactic acid material.
Further improvement of the present invention is: degradation solution adopts polylactic acid temperature-sensitive hydrogel.
The present invention also provides a kind of induction system of the novel degradable stopper through conduit implantation, comprise long sheath, inner core, loader, push rod and infusion tube, described push rod is connected with stopper spiral, in stopper income loader, described inner core is inserted described long sheath inside and is connected by screw thread, described loader is connected with long sheath, by pushing described push rod in body, stopper is slided until diseased region in long sheath, described stopper from long sheath distal out, described push rod is enclosed within described loader inside and is connected by haemostatic valve, described infusion tube is enclosed within the inside of described push rod and is connected by female Luer, by described infusion tube to stopper infusion degradation solution.
Further improvement of the present invention is: push rod is made up of stainless steel tube, and its far-end is provided with external screw thread, and external screw thread matches with the female thread on support bar, and near-end is fixedly connected with outer female Luer.
Further improvement of the present invention is: infusion tube is that stainless steel tube is made, and its far-end is sharp inclined plane shape, and its near-end is fixedly connected with inside/outside female Luer.
Beneficial effect of the present invention: the invention provides a kind of novel degradable stopper implanted through conduit and comprise sacculus, support bar and degradation solution, support bar is connected with sacculus, degradation solution is can the biomaterial of degraded and absorbed, be filled in balloon interior to play a supporting role, because the material of this stopper all adopts degradation material, there is good biocompatibility, there is good biological degradability in vivo, do not leave any foreign body in vivo, untoward reaction can not be produced to human body, long-term effect is remarkable, therefore it is safe for acting on human body as apparatus, stop the precipitation of NiTi alloys occluder due to nickel ion to the potential risk of human body, stopper adopts balloon structure, inner filling material is degradation solution, this degradation solution is temperature-sensitive hydrogel, when the abnormal defect of shutoff, due to the mobility characteristic of sacculus elastomer and liquid, stopper can be made to fit in completely around defect, stop the occurrence probability of residual shunt, particularly there is better plugging effect to irregular defect, in addition, the implant of stopper is temperature-sensitive hydrogel, by mixing with a certain proportion of contrast agent under low temperature, can be high-visible under X-ray line during injection sacculus, the operation being convenient to Minimally Invasive Surgery is carried out, improve degree of accuracy and the success rate of operation, stopper of the present invention, can design in different size, its specification size is identical with common NiTi alloys occluder specification.According to design concept of the present invention, this stopper not only goes for the shutoff of patent ductus arteriosus, also by changing balloon features, can be made into and being applicable to the stopper of atrial septal defect and the stopper of ventricular septal defect simultaneously.The sharp inclined-plane of the infusion tube far-end of induction system is by penetrating isolating membrane, to balloon interior injection degradation solution, degradation solution is by the circular hole Filled Balloon on support bar, sacculus fills backed off after random infusion tube, isolating membrane elastic closure, stop that degradation solution spills, by regulating push rod, full sacculus is positioned over defect, due under degradation solution in vivo temperature in gel, there is certain support force, block abnormal blood flow, be rotated counterclockwise push rod and balloon occluder device and push rod are departed from, exit push rod and sheath pipe, get final product complete operation.
Structure of the present invention is simple, novel in design, convenient and practical, devises the first heart stopper that late result is better, risk is less.
Accompanying drawing explanation
Fig. 1 is degradable stopper structural representation.
Fig. 2 is the schematic diagram after stopper of the present invention folds.
Fig. 3 is the general assembly schematic diagram of stopper of the present invention and induction system.
Fig. 4 is the long sheath schematic diagram of induction system
Fig. 5 is induction system inner core schematic diagram
Fig. 6 is the schematic diagram of loader
Fig. 7 is the schematic diagram of push rod
Fig. 8 is the schematic diagram of infusion tube
Fig. 9 is this stopper implantation cardiac position schematic diagram
Figure 10 is the block diagram of induction system operation
Wherein: 1-sacculus, 2-support bar, 3-circular hole, 4-is hemispherical, 5-degradation solution, 6-isolating membrane, 7-female thread, 8-closes up, 9-sheath pipe, 10-sheath pipe joint, 11-tip configurations, 12-inner catheter, 13-inner core joint, 14-fastening, the short sheath pipe of 15-, 16-sheath pipe joint, 17-haemostatic valve, 18-external screw thread, 19-stainless steel tube, the outer female Luer of 20-, the sharp inclined plane shape of 21-, 22-stainless steel tube, 23-inside/outside female Luer.
Detailed description of the invention
In order to deepen the understanding of the present invention, be described in further detail the present invention below in conjunction with drawings and Examples, the present embodiment, only for explaining the present invention, not forming protection scope of the present invention and limiting.
Embodiment as shown in Figure 1-2, the present embodiment provides a kind of novel degradable stopper implanted through conduit, comprise sacculus 1, support bar 2 and degradation solution 5, described support bar 2 is fixedly connected with sacculus 1, described sacculus 1 is wrapped in the periphery of support bar 2, described degradation solution 5 is can the biomaterial of degraded and absorbed, be filled in described sacculus 1 inside to play a supporting role, described support bar 2 near-end is provided with female thread 7, isolating membrane 6 is provided with in described female thread 7, described female thread 7 is depressed in described sacculus 1 center, the far-end of described sacculus 1 one end and described support bar 2 is connected by welding manner and is hemispherical, the other end is connected to near-end female thread 7 place of support bar 2, described support bar 2 is the single lumen catheters be made up of degradation material, the far-end of described support bar 2 is hemispherical 4, and be depressed in described sacculus 1 center, described sacculus 1 is that degradation material polylactic acid is through Mould Machining obtained by molding, sacculus 1 distal diameter 3 ~ 5mm larger than waist diameter, length of balloon 7 ~ 10mm, different size is made into according to waist diameter, several circular holes 3 are provided with in the middle part of described support bar 2, described sacculus 1 and support bar 2 all adopt poly-lactic acid material, described degradation solution 5 adopts polylactic acid temperature-sensitive hydrogel.
Biodegradable material is compared Nitinol and is had better biocompatibility, can also under the effect of tissue liquid, enzyme etc., there is the degraded of hydrolysed form, finally be degraded into the micromolecule that energy biological metabolism is discharged or absorbed by body, sacculus and the support bar of the first heart stopper of degradable of the present invention all adopt poly-lactic acid material, this material is a kind of novel degradable material, there is good biocompatibility, as medical macromolecular materials, polylactic acid resolves into lactic acid in vivo, generates CO in the metabolism through enzyme
2and H
2o, degradation solution adopts polylactic acid temperature-sensitive hydrogel, temperature-sensitive hydrogel characteristic: the aqueous solution of polymer 20% is when temperature is lower than phase transition temperature (28 degree), aqueous solutions of polymers is collosol state, is free-pouring liquid, and temperature is increased to more than phase transition temperature (28 degree), the aqueous solution of polymer undergoes phase transition, form non-chemically crosslinked gel, and the process forming gel is reversible, and the transformation of gel-solution can occur again when temperature reduces.Human body is expelled to after mixing with a certain proportion of contrast agent under low temperature, gel is formed fast under human temperature, thus fill sacculus as supporter, and then the defect of shutoff heart, As time goes on, epithelization is formed on plugging device surface, by 6 months to 2 years, formative tissue cell gradually, heal in defect place, polylactic acid is slowly degraded and is finally disappeared, and does not leave any foreign body in vivo.
Polylactic acid or its copolymer not only have good biocompatibility, there are again good mechanical performance and physical property simultaneously, polylactic resin is thermoplastic, there is the performance similar with low-density polystyrene to polyethylene, the process equipment of general-purpose plastics can be adopted to carry out machine-shaping, and therefore, its support bar is single lumen catheter, sacculus is film like, all can realize under existing process conditions.Made in conduit by expressing technique, polylactic acid is prepared through special process, can be made into and has certain flexibility and elastic thin film, then by thermoplastic or welding manner, support bar and sacculus is connected.Polylactic acid by under low temperature be expelled in body after medicament mixed, under human body temperature, form gel, thus blocking defect, medicament mixed can adopt a certain proportion of contrast agent, under being conducive to X-ray line, observe fractions distribution.
Embodiment as shown in figures 3-8, the present embodiment provides a kind of induction system of the novel degradable stopper through conduit implantation, comprise long sheath, inner core, loader, push rod and infusion tube, described push rod is connected with stopper spiral, in stopper income loader, described inner core is inserted described long sheath inside and is connected by screw thread, described loader is connected with long sheath, by pushing described push rod in body, stopper is slided until diseased region in long sheath, described stopper from long sheath distal out, described push rod is enclosed within described loader inside and is connected by haemostatic valve 17, described infusion tube is enclosed within the inside of described push rod and is connected by female Luer, by described infusion tube to stopper infusion degradation solution 5, described long sheath comprises sheath pipe 9 and sheath pipe joint 10, the far-end of sheath pipe 9 has closing in 8, near-end is connected with sheath pipe joint 10, described inner core comprises inner catheter 12 and inner core joint 13, the far-end of inner catheter 12 becomes tip configurations 11, near-end is connected with inner core joint 13, described loader comprises short sheath pipe 15, fastening 14, sheath pipe joint 16 and haemostatic valve 17, described push rod is made up of stainless steel tube 19, its far-end is provided with external screw thread 18, described external screw thread 18 matches with the female thread 7 on described support bar 2, near-end is fixedly connected with 20 with outer female Luer, described infusion tube is that stainless steel tube 22 is made, stainless steel tube 22 diameter is less than the diameter of stainless steel tube 19, want during use to make stainless steel tube 22 through stainless steel tube 19, its far-end is sharp inclined plane shape 21, its near-end is fixedly connected with 23 with inside/outside female Luer.
The sheath pipe of induction system is teflon catheter, and inner core is high density polyethylene conduit, and joint is makrolon material; Push rod adopts stainless steel tube, far-end welding external spiral, near-end soldering stainless steel female Luer; Infusion tube is also stainless steel tube, and its external diameter can be inner through push rod, and its far-end is sharp inclined-plane, near-end welding female Luer.
Stopper operation principle of the present invention: the present invention can adopt degradation material to make by degradable patend ductus arteriosus occluder, by preforming sacculus shape support, again to ball intracapsular injection degradation solution, be liquid during degradation solution low temperature, can free-flow, can fit closely knit with defect edge, degradation solution temperature raises when reaching body temperature and is converted into gel, can supporting balloon shutoff defect.As time goes on, form epithelization on plugging device surface, by 6 months to 2 years, formative tissue cell gradually, heal in defect place, polylactic acid is slowly degraded and finally disappeared, and does not leave any foreign body in vivo.
A kind of novel degradable stopper through conduit implantation and induction system operating process thereof as shown in figs. 9-10:
Conventional percutaneous puncture, step one
(S01): by inner core through long sheath, sheath pipe joint 10 is connected with inner core joint 13 spiral;
Step 2
(S02): guide wire passes from the tip configurations 11 of inner core, pushes the long sheath and inner core that are integrally connected along guide wire, when sheath pipe far-end arrives diseased region, exits inner core;
Step 3
(S03): the support bar internal coiling 7 of the degradable stopper of dimension is connected with push rod external spiral 18, because this stopper is folding in fine strip shape (Fig. 2) in advance, in the sheath pipe 15 of income loader;
Step 4
(S04): loader is connected long sheath, the fastening 14 of loader is connected with sheath pipe joint 10 spiral of long sheath;
Step 5
(S05): in body, push push rod, this stopper at sheath in-pipe, when moving to diseased region and exposing from the closing in 8 of long sheath;
Step 6
(S06): by infusion tube through push rod inner chamber, be locked in the outer female Luer 20 of push rod by the female Luer 23 of infusion tube, the sharp inclined-plane 21 of infusion tube far-end penetrates isolating membrane 6 simultaneously;
Step 7
(S07): syringe is connected to the female Luer 23 of infusion tube, and to balloon interior injection degradation solution, degradation solution is by several circular holes 3 Filled Balloon on support bar, and sacculus fills backed off after random infusion tube, isolating membrane elastic closure, stops that degradation solution spills;
Step 8
(S08): by regulating push rod that full sacculus is positioned over defect, owing to being gel under degradation solution in vivo temperature, there is certain support force, block abnormal blood flow;
Step 9
(S09): be rotated counterclockwise push rod and this stopper and push rod are departed from, exit push rod and sheath pipe, complete operation.
Structure of the present invention is simple, novel in design, convenient and practical, devises the first heart stopper that late result is better, risk is less, major advantage:
1, because the material of this stopper all adopts degradation material, there is good biocompatibility, there is good biological degradability in vivo, do not leave any foreign body in vivo, untoward reaction can not be produced to human body, long-term effect is remarkable, and it is safe for therefore acting on human body as apparatus, has stopped the precipitation of NiTi alloys occluder due to nickel ion to the potential risk of human body.
2, because this stopper have employed balloon structure, inner filling material is degradation solution, this degradation solution is temperature-sensitive hydrogel, when the abnormal defect of shutoff, due to the mobility characteristic of sacculus elastomer and liquid, stopper can be made to fit in completely around defect, stopped the occurrence probability of residual shunt, particularly had better plugging effect to irregular defect.
3, because the implant of this stopper is temperature-sensitive hydrogel, by mixing with a certain proportion of contrast agent under low temperature, can be high-visible under X-ray line during injection sacculus, the operation being convenient to Minimally Invasive Surgery is carried out, and improves degree of accuracy and the success rate of operation.
4, stopper of the present invention, can design in different size, and its specification size is identical with common NiTi alloys occluder specification.
5, according to design concept of the present invention, this stopper not only goes for the shutoff of patent ductus arteriosus, also by changing balloon features, can be made into and being applicable to the stopper of atrial septal defect and the stopper of ventricular septal defect simultaneously.
Claims (11)
1. the novel degradable stopper implanted through conduit, it is characterized in that: comprise sacculus (1), support bar (2) and degradation solution (5), described support bar (2) is fixedly connected with sacculus (1), described sacculus (1) is wrapped in the periphery of support bar (2), described degradation solution (5) is can the biomaterial of degraded and absorbed, is filled in described sacculus (1) inner to play a supporting role.
2. a kind of novel degradable stopper implanted through conduit according to claim 1, it is characterized in that: described support bar (2) near-end is provided with female thread (7), be provided with isolating membrane (6) in described female thread (7), described female thread (7) is depressed in described sacculus (1) center.
3. a kind of novel degradable stopper implanted through conduit according to claim 2, it is characterized in that: described support bar (2) is the single lumen catheter be made up of degradation material, the far-end of described support bar (2) is hemispherical (4), and is depressed in described sacculus (1) center.
4. a kind of novel degradable stopper implanted through conduit according to claim 3, it is characterized in that: the far-end of described sacculus (1) one end and described support bar (2) is connected by welding manner and is hemispherical, and the other end is welded in near-end female thread (7) place of support bar (2).
5. a kind of novel degradable stopper implanted through conduit according to any one of claim 1-4, it is characterized in that: described sacculus (1) is for degradation material polylactic acid is through Mould Machining obtained by molding, sacculus (1) distal diameter 3 ~ 5mm larger than waist diameter, sacculus (1) length 7 ~ 10mm, is made into different size according to waist diameter.
6. a kind of novel degradable stopper implanted through conduit according to claim 5, is characterized in that: described support bar (2) middle part is provided with several circular holes (3).
7. a kind of novel degradable stopper implanted through conduit according to claim 6, is characterized in that: described sacculus (1) and support bar (2) all adopt poly-lactic acid material.
8. a kind of novel degradable stopper implanted through conduit according to claim 6, is characterized in that: described degradation solution (5) adopts polylactic acid temperature-sensitive hydrogel.
9. the induction system of the novel degradable stopper implanted through conduit, it is characterized in that: comprise long sheath, inner core, loader, push rod and infusion tube, described push rod is connected with stopper spiral, in stopper income loader, described inner core is inserted described long sheath inside and is connected by screw thread, described loader is connected with long sheath, by pushing described push rod in body, stopper is slided until diseased region in long sheath, described stopper from long sheath distal out, described push rod is enclosed within described loader inside and is connected by haemostatic valve (17), described infusion tube is enclosed within the inside of described push rod and is connected by female Luer, by described infusion tube to stopper infusion degradation solution (5).
10. the induction system of a kind of novel degradable stopper through conduit implantation according to claim 9, it is characterized in that: described push rod is made up of stainless steel tube (19), its far-end is provided with external screw thread (18), described external screw thread (18) matches with the female thread (7) on the support bar (2) of described stopper, and near-end is fixedly connected with (20) with outer female Luer.
The induction system of 11. a kind of novel degradable stoppers through conduit implantation according to claim 9, it is characterized in that: described infusion tube is that stainless steel tube (22) is made, its far-end is sharp inclined plane shape (21), and its near-end is fixedly connected with (23) with inside/outside female Luer.
Priority Applications (1)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| CN201410094207.XA CN104905890B (en) | 2014-03-14 | A kind of novel degradable plugging device and its transport system through conduit implantation |
Applications Claiming Priority (1)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| CN201410094207.XA CN104905890B (en) | 2014-03-14 | A kind of novel degradable plugging device and its transport system through conduit implantation |
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| Publication Number | Publication Date |
|---|---|
| CN104905890A true CN104905890A (en) | 2015-09-16 |
| CN104905890B CN104905890B (en) | 2018-08-31 |
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| CN105169549A (en) * | 2015-10-23 | 2015-12-23 | 李华 | Device preventing intrauterine adhesion |
| CN106037864A (en) * | 2016-07-21 | 2016-10-26 | 李勇 | Plugging device capable of injecting hydrogel for ureteroscope lithotripsy |
| CN106580386A (en) * | 2016-12-15 | 2017-04-26 | 成都迪康中科生物医学材料有限公司 | Absorbable uterine cavity saccule |
| CN106859722A (en) * | 2017-03-17 | 2017-06-20 | 广州新诚生物科技有限公司 | A kind of sacculus left atrial appendage occlusion device |
| WO2018161359A1 (en) * | 2017-03-10 | 2018-09-13 | 杭州诺茂医疗科技有限公司 | Interventional medical instrument conveying system |
| CN111212607A (en) * | 2017-09-23 | 2020-05-29 | 苏黎世大学 | Medical occluder device |
| CN115252037A (en) * | 2019-01-10 | 2022-11-01 | 卡特纳医疗有限公司 | Occluder insertion system |
| US11944315B2 (en) | 2019-09-26 | 2024-04-02 | Universität Zürich | Left atrial appendage occlusion devices |
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| CN105169549A (en) * | 2015-10-23 | 2015-12-23 | 李华 | Device preventing intrauterine adhesion |
| CN106037864A (en) * | 2016-07-21 | 2016-10-26 | 李勇 | Plugging device capable of injecting hydrogel for ureteroscope lithotripsy |
| CN106580386B (en) * | 2016-12-15 | 2019-11-05 | 成都迪康中科生物医学材料有限公司 | A kind of absorbable uterine cavity sacculus |
| CN106580386A (en) * | 2016-12-15 | 2017-04-26 | 成都迪康中科生物医学材料有限公司 | Absorbable uterine cavity saccule |
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| CN106859722B (en) * | 2017-03-17 | 2020-05-19 | 广州新诚生物科技有限公司 | Sacculus left auricle plugging device |
| CN106859722A (en) * | 2017-03-17 | 2017-06-20 | 广州新诚生物科技有限公司 | A kind of sacculus left atrial appendage occlusion device |
| CN111212607A (en) * | 2017-09-23 | 2020-05-29 | 苏黎世大学 | Medical occluder device |
| CN115252037A (en) * | 2019-01-10 | 2022-11-01 | 卡特纳医疗有限公司 | Occluder insertion system |
| CN115252037B (en) * | 2019-01-10 | 2023-10-31 | 卡特纳医疗有限公司 | Plugging device insertion system |
| US11944315B2 (en) | 2019-09-26 | 2024-04-02 | Universität Zürich | Left atrial appendage occlusion devices |
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