CN108852578B - Implant capable of being degraded naturally - Google Patents

Implant capable of being degraded naturally Download PDF

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Publication number
CN108852578B
CN108852578B CN201811025986.2A CN201811025986A CN108852578B CN 108852578 B CN108852578 B CN 108852578B CN 201811025986 A CN201811025986 A CN 201811025986A CN 108852578 B CN108852578 B CN 108852578B
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China
Prior art keywords
balloon
degradable material
implant
naturally
naturally degradable
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CN201811025986.2A
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CN108852578A (en
Inventor
陈珊珊
石秀凤
张强
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Shanghai Panda Medical Co ltd
Changzhou Panda Medical Co ltd
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Shanghai Panda Medical Co ltd
Changzhou Panda Medical Co ltd
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Priority to CN201811025986.2A priority Critical patent/CN108852578B/en
Publication of CN108852578A publication Critical patent/CN108852578A/en
Priority to PCT/CN2018/119122 priority patent/WO2020048029A1/en
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    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61FFILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
    • A61F5/00Orthopaedic methods or devices for non-surgical treatment of bones or joints; Nursing devices; Anti-rape devices
    • A61F5/0003Apparatus for the treatment of obesity; Anti-eating devices
    • A61F5/0013Implantable devices or invasive measures
    • A61F5/003Implantable devices or invasive measures inflatable
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61BDIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B90/00Instruments, implements or accessories specially adapted for surgery or diagnosis and not covered by any of the groups A61B1/00 - A61B50/00, e.g. for luxation treatment or for protecting wound edges
    • A61B90/02Devices for expanding tissue, e.g. skin tissue
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61FFILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
    • A61F5/00Orthopaedic methods or devices for non-surgical treatment of bones or joints; Nursing devices; Anti-rape devices
    • A61F5/0003Apparatus for the treatment of obesity; Anti-eating devices
    • A61F5/0013Implantable devices or invasive measures
    • A61F5/0036Intragastrical devices

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  • Health & Medical Sciences (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Animal Behavior & Ethology (AREA)
  • General Health & Medical Sciences (AREA)
  • Veterinary Medicine (AREA)
  • Engineering & Computer Science (AREA)
  • Biomedical Technology (AREA)
  • Heart & Thoracic Surgery (AREA)
  • Public Health (AREA)
  • Vascular Medicine (AREA)
  • Child & Adolescent Psychology (AREA)
  • Obesity (AREA)
  • Nursing (AREA)
  • Orthopedic Medicine & Surgery (AREA)
  • Surgery (AREA)
  • Oral & Maxillofacial Surgery (AREA)
  • Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
  • Pathology (AREA)
  • Dermatology (AREA)
  • Medical Informatics (AREA)
  • Molecular Biology (AREA)
  • Materials For Medical Uses (AREA)
  • Surgical Instruments (AREA)

Abstract

The application discloses a degradable implant which is used for occupying the internal space of a patient body and comprises a balloon main body, a degradable material and a fluid conveying accessory, wherein the fluid conveying accessory comprises a self-closing valve and a catheter which are fixed on the balloon, fluid is injected into the balloon through the catheter, a release channel is opened after the degradable material is degraded, and the fluid is discharged from the balloon, wherein the degradable material is a material which can be naturally degraded, and the naturally degradable material is positioned on the surface of the balloon main body or at the joint part of an upper balloon and a lower balloon. The implant is automatically degraded after being implanted into a human body for a period of time, the release channel is opened, external forces such as an external magnetic field, microwaves or changing the pH value in the stomach are not needed to induce degradation, the degraded saccule can be easily discharged out of the body, and the implant is not needed to be taken out by an operation, so that the pain of a patient is relieved.

Description

Implant capable of being degraded naturally
Technical Field
The present application relates to implants, and in particular to a naturally degradable implant.
Background
Worldwide, the incidence of obesity, including adult obesity, senile obesity, and juvenile obesity, has risen dramatically during the past 20 years. According to world health organization statistics, there were 15% adult females and 11% adult males obese worldwide in 2014, which means that there were nearly billions of adult obese worldwide in 2014. The obese population of China has been surmounted by the united states, 8960 ten thousand obese population in 2016 (8780 ten thousand obese population in the united states), with 4320 ten thousand men and 4640 ten thousand women. Obesity is often accompanied by hypertension, type II diabetes, ischemic heart disease, dyslipidemia, joint degeneration, sleep apnea, certain tumors, etc., and therefore, how to effectively control body weight, prevent and control the occurrence of complications is a topic of great concern.
The main current treatment modalities for obesity include: diet control, life intervention, drug treatment, and surgical treatment. However, the satisfactory weight-reducing effect is hardly achieved by simple diet control, living intervention and drug treatment; although the effect of the weight-reduction surgery is obvious, the weight-reduction surgery is hardly accepted by patients due to cultural, medical level, surgical complications and the like. Implantable medical devices lose weight, mimic the mechanism of surgical treatment of obesity, including intragastric balloons, which has recently emerged as a safe, simple, effective, restorable, and therefore receiving widespread attention and becoming a major effective means of losing weight in the future.
There are several types of intragastric balloons that are currently marketed abroad, and particularly intragastric balloons that are self-swallowed without being delivered through a gastroscope, are the direction of future weight loss means. The swallowed intragastric balloon is wrapped in the capsule before action and is connected with a longer catheter, one end of the catheter is connected with a self-closing valve on the intragastric balloon, and the other end of the catheter is left outside the capsule and the oral cavity. The balloon and part of the catheter wrapped in the capsule are fed into the stomach of a patient in a swallowing manner, the capsule is rapidly degraded in the gastric acid environment, fluid is conveyed into the balloon from the outer end of the catheter left outside the mouth of the patient, and the balloon is inflated from an initial compressed state to an expanded state. After the fluid is delivered, the catheter is pulled out from the patient, and the self-closing valve on the balloon and forming a fluid channel with the catheter is automatically closed so as to prevent the fluid from leaking. One such implant balloon is disclosed in US8974483B2, see in particular fig. 1.
As shown in fig. 1, the implant balloon disclosed in US8974483B2 includes a hydrogel filler 108 pre-disposed in the balloon, and after fluid is delivered into the balloon 100 through the catheter 200, the filler 108 is inflated to expand the balloon 100 in a compressed state. The degradable material 106 located inside the balloon mechanically seals the release channel and the degradable material 106 degrades under the influence of the filler or other externally applied substance opening the release channel.
A disadvantage of this configuration is that the pre-addition of filler 108 increases the initial volume of the balloon, which is not convenient for the patient to swallow. Meanwhile, the degradable material needs to be degraded by filling materials or other additional substances, and the operation is complex. Thus, how to design an implant that does not require pre-placement of the filler, while the degradable material can degrade naturally, is an urgent problem in the art.
Disclosure of Invention
In order to solve the problems in the prior art, the application provides a novel naturally degradable implant, wherein the implant is not provided with a filler in advance, and a degradable material can be automatically degraded without an additional substance.
The present application provides a naturally degradable implant for occupying an interior space of a patient's body. The implant includes sacculus main part, degradable material and fluid transport annex, and wherein fluid transport annex is including being fixed in self-closing valve and the pipe on the sacculus, through the pipe with fluid injection sacculus inside, open the release channel after the degradable material degradation, fluid is discharged from the sacculus, its characterized in that: the degradable material is a material which can be naturally degraded, and the material which can be naturally degraded is positioned on the surface of the balloon main body or the combination part of the upper balloon and the lower balloon.
In one embodiment, the naturally degradable material is a polylactic acid-based copolymer, preferably the naturally degradable material is a polylactic acid-caprolactone copolymer or a polylactic acid-trimethylene carbonate copolymer. The naturally degradable material may also be polydioxanone.
The balloon body includes at least one release channel thereon, the release channel being sealed with a naturally degradable material.
Preferably, the naturally degradable material is bonded to the surface of the balloon body in the form of a patch. The shape of the naturally degradable material can be elliptic, which is similar to the cross section of the capsule, so that the damage to the naturally degradable material caused by over folding in the folded state is avoided.
Preferably, the outer periphery and the outer peripheral surface of the naturally degradable material are covered with a cover layer made of at least one layer of balloon body material or other liquid impermeable material to control the separation time of the naturally degradable material from the balloon body.
In another embodiment, the balloon comprises an upper balloon layer and a lower balloon layer, which are joined at edges to form a unitary structure. At least one layer of naturally degradable material is arranged in the middle of the joint part of the upper layer of the saccule and the lower layer of the saccule, so as to form a naturally degradable release channel.
The bonding mode between the naturally degradable materials and the combination mode of the naturally degradable materials and the balloon body comprises bonding or welding.
The implant of the present application may be used as an intragastric balloon as well as a skin dilation balloon.
According to the natural degradable implant, the filling material is not placed in the balloon in advance, so that the balloon can be folded to a smaller volume, and the patient can swallow conveniently. The degradable material on the surface of the balloon or between the upper balloon and the lower balloon is a material which can be naturally degraded, the degradable material is automatically degraded after being implanted into a human body for a period of time, a release channel is opened, external magnetic field, microwaves or external force such as changing the pH value in the stomach are not needed to induce degradation, the balloon can be easily discharged out of the body after natural degradation, and the degradable material is not needed to be taken out by an operation, so that the pain of a patient is relieved.
Drawings
The accompanying drawings are included to provide a further understanding of the application, and are incorporated in and constitute a part of this specification, illustrate the application and together with the description serve to explain the application.
FIG. 1 is a schematic view of a balloon structure according to the prior art;
FIG. 2 is a schematic structural view of a balloon system according to one embodiment of the present application;
FIG. 3A is a top view of a balloon and naturally degradable material;
FIG. 3B is a schematic illustration of the outer perimeter and outer edge surface coverings of the naturally degradable material;
FIG. 4 is a balloon, naturally degradable material and exploded view thereof according to another embodiment of the present application;
FIG. 5 is a top view of the balloon and naturally degradable material assembled according to FIG. 4;
Fig. 6 is a side view of naturally degradable material and upper and lower layers of the balloon.
Reference numerals in the drawings: 1-edge; 2-turning holes; 100-balloon; 102-balloon shell; 103-a release channel; 104-a naturally degradable material; 105-a cover layer; 1051-outer edge; 1052-inner edge; 106-a degradable material; 108-filling; 110-balloon upper layer; 120-balloon lower layer; 200-catheter.
Detailed Description
The present application will be further described with reference to the following detailed description, wherein the drawings are for illustrative purposes only and are shown in schematic drawings, rather than physical drawings, and are not to be construed as limiting the present application, and in order to better explain the detailed description of the application, certain components of the drawings may be omitted, enlarged or reduced in size, and not represent the actual product, and it will be understood by those skilled in the art that certain well-known structures in the drawings and descriptions thereof may be omitted, and that all other embodiments obtained by those skilled in the art without making creative efforts fall within the scope of protection of the application based on the detailed description of the present application.
Referring to fig. 2, a schematic structural view of a naturally degradable implant according to one embodiment of the present application is shown. Preferably, the implant is an in vivo implanted balloon system, such as an intragastric balloon system, and those skilled in the art will readily appreciate that the balloon system of the present application may be a balloon system for other purposes, such as a skin dilation balloon, and the like. An in vivo implantation balloon system comprising: balloon 100, catheter 200, and a capsule (not shown). Balloon 100 is encased in a capsule prior to swallowing, and catheter 200 is connected at one end to a self-sealing valve on balloon 100.
The structure and manufacturing method of the balloon system of this embodiment are described in detail below with reference to the accompanying drawings. Referring to fig. 3A, the balloon shell 102 is made of a flexible material such as silicone rubber or polyurethane, and has at least one opening as a release channel 103, and the naturally degradable material 104 seals the release channel in the form of a patch, and the bonding manner of the naturally degradable material 104 and the balloon shell 102 includes bonding or welding.
The natural degradable material can be polylactic acid-based copolymer, preferably the natural degradable material is polylactic acid-caprolactone copolymer or polylactic acid-trimethylene carbonate copolymer, the thickness of the film is 10-100 micrometers, and the natural degradable material is combined on the surface of the balloon to seal the release channel. In other embodiments, the naturally degradable material is polydioxanone. The naturally degradable material may be circular, oval, square, or any other shape.
Fig. 3B shows a cover layer 105 on the outer periphery and outer edge surface of the naturally degradable material 104, where the cover layer 105 is in a ring-shaped structure, and is made of a balloon main body material or other liquid impermeable material, and the outer edge 1051 is bonded or welded to the balloon shell 102, and the inner edge 1052 is bonded or welded to the naturally degradable material 104, so as to control the separation time of the naturally degradable material 104 from the balloon shell 102.
Fig. 4-6 show schematic structural views of a naturally degradable implant according to another embodiment of the application, which differs from the embodiment shown in fig. 3 in that: the naturally degradable material is positioned at the joint of the upper and lower balloons. The structure and manufacturing method of the balloon system of this embodiment are described in detail below with reference to fig. 4 to 6.
Specifically, fig. 4 shows the balloon 100, the naturally degradable material 104 and an exploded view thereof, wherein the balloon 100 comprises a balloon upper layer 110 and a balloon lower layer 120, and a turnover hole 2 is arranged on the balloon upper layer 110; the balloon upper layer 110, the balloon lower layer 120 and the at least one layer of naturally degradable material 104 are joined together at the rim 1 by bonding or welding to form a unitary structure. The naturally degradable material 104 is located intermediate the junction of the balloon upper layer 110 and the balloon lower layer 120, forming a degradable release channel. After the combination is completed, the balloon is turned through the turning hole 2 on the upper layer 110 of the balloon. Finally, the overturning holes 2 on the upper balloon layer 110 are closed by patches to form the complete balloon, as shown in fig. 5.
Fig. 6 shows a side view of the degradable material and the upper and lower balloons, as shown in fig. 6, at least one layer of naturally degradable material 104 is provided between the junction of the upper balloon 110 and the lower balloon 120, the naturally degradable material 104 forms a release channel due to hydrolysis, the structural integrity of the balloon is destroyed, and the filler in the balloon flows out.
The use of the intragastric balloon according to the application is as follows: after the patient swallows the capsule containing balloon 100 and a portion of catheter 200, the capsule rapidly dissolves in the stomach environment, and a filler, which may be a liquid or a gas, is delivered into balloon 100 through the outer end of catheter 200. Balloon 100 changes from an initial compressed state to an inflated state. After the filling, the catheter 200 is pulled out, and the self-closing valve is automatically closed under the pressure of the filler in the balloon 100, so that the leakage of the filler in the balloon is blocked. Balloon 100 occupies the intragastric volume for weight reduction purposes. After implantation in a human body for a period of time, the naturally degradable material 104 hydrolyzes, the release pathway is opened, the structural integrity of the balloon 100 is destroyed, the balloon inner filling is discharged into the stomach of the patient, and the emptied balloon shell 102 is finally naturally discharged out of the body along with gastrointestinal peristalsis.
According to the naturally degradable implant of the present application, no filler is pre-placed in balloon 100, ensuring that the balloon can be folded to a smaller volume for ease of swallowing by the patient. The degradable material 104 outside the balloon is a material which can be naturally degraded, and is automatically degraded after being implanted into a patient for a period of time, a release channel is opened, external force such as an external magnetic field, microwaves or changing the pH value in the stomach is not needed to induce degradation, the balloon shell 102 can be easily discharged out of the body after natural degradation, and the balloon shell is not needed to be taken out by an operation, so that the pain of the patient is relieved.
Although particular embodiments of the present application have been shown and described, it will be understood by those skilled in the art that various changes, modifications, substitutions and alterations may be made therein without departing from the principles and spirit of the application, the scope of which is defined in the appended claims and their equivalents.

Claims (7)

1. An implant comprising a balloon body, a degradable material and a fluid delivery accessory, wherein the fluid delivery accessory comprises a self-closing valve and a catheter which are fixed on the balloon body, fluid is injected into the balloon body through the catheter, a release channel is opened after the degradable material is degraded, the fluid is discharged from the balloon body, and the degradable material is a naturally degradable material, and the implant is characterized in that the balloon body comprises at least one release channel which is sealed by the naturally degradable material; the naturally degradable material is combined on the surface of the balloon main body in the form of a patch;
the outer periphery and the outer edge surface of the naturally degradable material are covered with a covering layer made of at least one layer of balloon main body material or other liquid impermeable materials so as to control the separation time of the naturally degradable material and the balloon main body;
The upper layer of the balloon is provided with a turnover hole, the upper layer of the balloon and the lower layer of the balloon are connected and combined at the edge to form an integral structure, the turnover hole of the upper layer of the balloon is turned after the combination is finished, and the turnover hole of the upper layer of the balloon is closed by a patch to form a complete balloon main body;
the natural degradable material is polylactic acid-based copolymer or polydioxanone.
2. The implant of claim 1, wherein the cover is annular in shape, with an outer edge bonded or welded to the balloon housing and an inner edge bonded or welded to the naturally degradable material.
3. The implant of claim 2, wherein the naturally degradable material can be oval, round, square, or any other shape.
4. An implant according to any one of claims 1 to 3, wherein the bonding between and between the naturally degradable material and the balloon body comprises bonding or welding.
5. The implant of claim 4, wherein the polylactic acid-based copolymer may be a polylactic acid-caprolactone copolymer or a polylactic acid-trimethylene carbonate copolymer.
6. The implant of claim 5, wherein the naturally degradable material is a film having a thickness of 10-100 microns.
7. The implant of any one of claims 1-3, which is an intragastric balloon or a skin-dilating balloon.
CN201811025986.2A 2018-09-04 2018-09-04 Implant capable of being degraded naturally Active CN108852578B (en)

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Application Number Priority Date Filing Date Title
CN201811025986.2A CN108852578B (en) 2018-09-04 2018-09-04 Implant capable of being degraded naturally
PCT/CN2018/119122 WO2020048029A1 (en) 2018-09-04 2018-12-04 Naturally degradable implant

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Application Number Priority Date Filing Date Title
CN201811025986.2A CN108852578B (en) 2018-09-04 2018-09-04 Implant capable of being degraded naturally

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CN108852578B true CN108852578B (en) 2024-05-28

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Families Citing this family (6)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
CN108852578B (en) * 2018-09-04 2024-05-28 常州至善医疗科技有限公司 Implant capable of being degraded naturally
CN110613541B (en) * 2019-09-29 2021-05-11 上海理工大学 Magnetic control type weight-losing capsule and assembly thereof
CN115040300A (en) * 2021-03-09 2022-09-13 常州至善医疗科技有限公司 Closing and releasing structure of implant in body
WO2022188617A1 (en) * 2021-03-09 2022-09-15 常州至善医疗科技有限公司 Closure and release structure for in-vivo implant
CN114145893A (en) * 2021-12-03 2022-03-08 杭州糖吉医疗科技有限公司 Swallowable intragastric water balloon and preparation method and set thereof
CN114159199A (en) * 2021-12-24 2022-03-11 山东百多安医疗器械股份有限公司 Weight-losing balloon with through hole and preparation method

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CN104623740A (en) * 2013-11-15 2015-05-20 微创心脉医疗科技(上海)有限公司 Medicine balloon and preparation method thereof
CN105358184A (en) * 2013-03-14 2016-02-24 Biodg股份有限公司 Implantable medical devices comprising bio-degradable alloys with enhanced degradation rates
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CN107744419A (en) * 2017-10-31 2018-03-02 上海盼达医疗科技有限公司 The self-enclosed structure of balloon-implant
CN108158705A (en) * 2017-12-18 2018-06-15 常州至善医疗科技有限公司 A kind of connection and release structure for balloon system
CN209548162U (en) * 2018-09-04 2019-10-29 常州至善医疗科技有限公司 It is a kind of can natural degradation implantation material

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Publication number Priority date Publication date Assignee Title
CN1590449A (en) * 2003-08-14 2005-03-09 韩国见喜株式会社 Additive composition for promoting degradation of plastics
CN102006843A (en) * 2008-04-14 2011-04-06 戈尔企业控股股份有限公司 Intragastric volume-occupying device
US8974483B2 (en) * 2012-02-21 2015-03-10 Allurion Technologies, Inc. Methods and devices for deploying and releasing a temporary implant within the body
CN105358184A (en) * 2013-03-14 2016-02-24 Biodg股份有限公司 Implantable medical devices comprising bio-degradable alloys with enhanced degradation rates
CN104623740A (en) * 2013-11-15 2015-05-20 微创心脉医疗科技(上海)有限公司 Medicine balloon and preparation method thereof
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CN209548162U (en) * 2018-09-04 2019-10-29 常州至善医疗科技有限公司 It is a kind of can natural degradation implantation material

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