CN111388842A - Drug-loaded balloon apparatus - Google Patents
Drug-loaded balloon apparatus Download PDFInfo
- Publication number
- CN111388842A CN111388842A CN202010237704.6A CN202010237704A CN111388842A CN 111388842 A CN111388842 A CN 111388842A CN 202010237704 A CN202010237704 A CN 202010237704A CN 111388842 A CN111388842 A CN 111388842A
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- filling
- catheter
- membrane
- cavity
- lumen
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Links
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- 239000012528 membrane Substances 0.000 claims abstract description 98
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- 206010011732 Cyst Diseases 0.000 claims description 3
- 229920002385 Sodium hyaluronate Polymers 0.000 claims description 3
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- 230000035755 proliferation Effects 0.000 claims description 3
- 210000002460 smooth muscle Anatomy 0.000 claims description 3
- 229940010747 sodium hyaluronate Drugs 0.000 claims description 3
- YWIVKILSMZOHHF-QJZPQSOGSA-N sodium;(2s,3s,4s,5r,6r)-6-[(2s,3r,4r,5s,6r)-3-acetamido-2-[(2s,3s,4r,5r,6r)-6-[(2r,3r,4r,5s,6r)-3-acetamido-2,5-dihydroxy-6-(hydroxymethyl)oxan-4-yl]oxy-2-carboxy-4,5-dihydroxyoxan-3-yl]oxy-5-hydroxy-6-(hydroxymethyl)oxan-4-yl]oxy-3,4,5-trihydroxyoxane-2- Chemical compound [Na+].CC(=O)N[C@H]1[C@H](O)O[C@H](CO)[C@@H](O)[C@@H]1O[C@H]1[C@H](O)[C@@H](O)[C@H](O[C@H]2[C@@H]([C@@H](O[C@H]3[C@@H]([C@@H](O)[C@H](O)[C@H](O3)C(O)=O)O)[C@H](O)[C@@H](CO)O2)NC(C)=O)[C@@H](C(O)=O)O1 YWIVKILSMZOHHF-QJZPQSOGSA-N 0.000 claims description 3
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Images
Classifications
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
- A61M25/00—Catheters; Hollow probes
- A61M25/10—Balloon catheters
- A61M25/104—Balloon catheters used for angioplasty
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
- A61M29/00—Dilators with or without means for introducing media, e.g. remedies
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
- A61M25/00—Catheters; Hollow probes
- A61M25/10—Balloon catheters
- A61M2025/1043—Balloon catheters with special features or adapted for special applications
- A61M2025/105—Balloon catheters with special features or adapted for special applications having a balloon suitable for drug delivery, e.g. by using holes for delivery, drug coating or membranes
Abstract
The invention discloses a drug-loaded balloon apparatus, which comprises a catheter, an inner membrane and an outer membrane, wherein the inner membrane is positioned at the radial outer side of the catheter, a fixed connecting part is arranged on the part of the inner membrane, at least a moving part is arranged on the rest part of the inner membrane except the fixed connecting part, and the fixed connecting part is fixedly connected with the outer wall of the catheter; a filling capsule cavity is formed between the outer membrane and the inner membrane, and at least one medicine carrying cavity which is formed before the filling capsule cavity is not filled and is filled with medicines and is unfolded after the filling capsule cavity is filled so as to separate the loaded medicines is arranged on the outer wall of the outer membrane; the displacement portion is displaced radially outwardly of the catheter during filling of the filling lumen to form a hollow passageway between the filling lumen and the catheter facilitating blood flow therethrough after the filling lumen is fully filled. The medicine realizes the ultrahigh wall sticking rate of the medicine on the inner wall of the blood vessel, and plays a great role in reducing the incidence rate of postoperative coronary restenosis.
Description
Technical Field
The invention relates to a medicine-carrying balloon instrument, and belongs to the technical field of medical instruments.
Background
Currently, arterial occlusive diseases (heart, brain, internal organs and peripheral blood vessels) caused by Atherosclerosis (AS) have become the leading cause of death in humans with aging population and dietary structure change. Currently, Percutaneous Transluminal Angioplasty (PTA) and endovascular stent placement have become the primary means for treating vascular stenosis. Compared with the traditional surgical operation treatment, the interventional method for opening the angiostenosis has the advantages of small injury, higher technical success rate, short hospitalization time, less complications, excellent curative effect, repeated application, no influence on other treatment methods and the like, thereby having wide application prospect.
But in-stent restenosis (ISR) becomes one of its major challenges. Although the use of drug-eluting stents (DES) has reduced the incidence of ISR, ISR remains of value as the number of patients undergoing Percutaneous Coronary Intervention (PCI) increases year by year. Also, researchers have found that the post-ISR treatment with DES secondary to drug eluting stents is relatively poor and the incidence of major cardiac events is higher compared to treating restenosis secondary to bare stents.
The medicine saccule is one new kind of medicine releasing saccule technology developed on the basis of saccule expanding operation, saccule forming operation and other intervention technology, and is one technology of coating antiproliferative medicine, such as taxol, onto the surface of saccule, expanding and contacting with the inner membrane of blood vessel wall to release and transfer medicine fast.
The pacocath technology is creatively provided by Invatec company, urea is used as a medicine carrier of paclitaxel to finally form free pac technology, the urea is non-toxic and harmless and has good biocompatibility, the medicine coating method adopts an accurate injection automatic coating technology, the prepared liquid medicine is accurately and quantitatively injected to the surface of an expanded balloon or the surface of a folded balloon, and animal experiment results show better results.
The research of L utonix company on 225 carriers, 250 formulations and 3400 drug balloons independently develops a novel carrier technology, and the coating fastness, the uniformity and the tissue absorption level of the drug carrier adopting polysorbate and sorbitol ester as paclitaxel are all optimized.
The health medical company develops a novel drug balloon technology by adopting a new drug coating technology, and prepares the drug balloon by a method of brushing or rolling paclitaxel drugs in a dry state through pretreatment of the surface of the balloon, so as to obtain the drug balloon with good crystalline state.
Zhejiang Guichuan medical instrument company has published a spraying technology of a medicinal balloon and explained the spraying technology, but the patent is in the public stage.
Although many companies are continuously improving the related technology level, most of them focus on the drug in the aspect of balloon surface structure and drug selection and attachment formation, how to finally and effectively attach the drug in sufficient quantity to the designated site is still the main problem faced by the current drug balloon technology, which can be briefly divided into two problems:
one of the problems is as follows: the current design of the drug balloon can not avoid crossing loss, because the naked drug of the drug balloon contacts with blood, and in addition, the drug is inevitably lost due to friction with blood vessels in the crossing process. The published data shows that the drug crossing loss rate of the pacocath technology and the free pac technology is more than 20%. Therefore, the key problem is how to reduce the loss rate of the drug coating in the process of passing through the drug balloon in the blood vessel and ensure the sufficient degree of the drug before reaching the designated part;
the second problem is that: the current design of drug balloon can not exceed 60s release time, because the long-term filling in the coronary artery easily causes the ischemic necrosis of the far-end myocardium, which causes the irreversible condition to happen. Therefore, how to prolong the expansion time after the drug balloon reaches the designated position to ensure that the drug is effectively released and increased without causing coronary ischemia is also a key problem capable of guiding innovative solutions.
Disclosure of Invention
The invention aims to overcome the defects of the prior art and provides a drug-carrying balloon apparatus, which avoids the drug loss of a drug balloon catheter in the process of passing through a blood vessel, opens a hollow area to allow blood flow to pass through when releasing, fundamentally breaks the limitation that the balloon expansion does not exceed 60 seconds, realizes the ultrahigh wall sticking rate of the drug on the inner wall of the blood vessel from the two aspects, and plays a great role in reducing the incidence rate of postoperative coronary restenosis.
In order to solve the technical problems, the technical scheme of the invention is as follows: a drug-loaded balloon apparatus, comprising:
a conduit;
the inner membrane is positioned on the radial outer side of the catheter, a fixed connecting part is arranged on the inner membrane, at least a moving part is arranged on the rest part of the inner membrane except the fixed connecting part, and the fixed connecting part is fixedly connected with the outer wall of the catheter;
the outer wall of the outer membrane is provided with at least one medicine carrying cavity which is formed before the filling capsule cavity is not filled, carries the medicine and is unfolded after the filling capsule cavity is filled so as to separate the carried medicine; wherein the content of the first and second substances,
the moving portion moves radially outward of the catheter during filling of the filling balloon cavity to form a hollow passageway between the filling balloon cavity and the catheter to facilitate blood flow therethrough after the filling balloon cavity is fully filled.
Further, in order to be able to inject the medium into the filling capsule cavity, the filling device further comprises a filling channel, wherein the filling channel is connected with the filling capsule cavity so as to inject the medium into the filling capsule cavity through the filling channel.
Further, the entry that fills the passageway is equipped with sufficient valve, the export that fills the passageway is located fixed connection portion department, and with sufficient bag chamber is linked together.
Further, a concrete structure that forms medicine carrying cavity is provided and is formed, medicine carrying cavity is including locating relatively two adventitia fold portions on the outer wall of adventitia:
the radial inner sides of the two outer membrane fold parts are connected;
the radially outer sides of the two outer membrane folds form an opening adapted to be adhesively closed prior to filling of the filling lumen and separated after filling of the filling lumen.
Further, the outer membrane fold is adhesively closed before the filling cavity is unfilled and separated after the filling cavity is filled, at least at a location near the opening.
Further, at least a portion of the displacement portion is adhesively attached to the outer wall of the catheter prior to the filling lumen being unfilled and detached from the outer wall of the catheter after the filling lumen is filled.
Further, at least a portion of the moving portion prior to filling of a lumen comprises:
a conduit bond adapted to bond with the conduit;
the radial outer sides of the two inner membrane folded parts are connected, and the radial inner sides of the two inner membrane folded parts are respectively connected with the corresponding conduit bonding parts;
the inner membrane folds are bonded closed before the filling cavity is not filled and separated after the filling cavity is filled at least at the position close to the opening.
Further, the outer membrane fold is adhesively closed before the filling cavity is not filled and separated after the filling cavity is filled at least at a position near the opening;
further, at least a portion of the moving portion prior to filling of a lumen comprises:
a conduit bond adapted to bond with the conduit;
the radial outer sides of the two inner membrane folded parts are connected, and the radial inner sides of the two inner membrane folded parts are respectively connected with the corresponding conduit bonding parts;
the inner membrane fold part is bonded and closed before the filling cavity is not filled at least at the part close to the opening and is separated after the filling cavity is filled;
the adhesion force of opening part < the adhesion force of adventitia fold portion < the pipe adhesion portion with the adhesion force of pipe < the adhesion force of intima fold portion to at the filling in-process that fills the cyst chamber, the opening part adventitia fold portion the pipe adhesion portion with bond department between the pipe with intima fold portion breaks away from in proper order.
Further, sodium hyaluronate is adopted for bonding at the opening and/or the outer membrane fold part and/or the bonding part between the catheter bonding part and the catheter and/or the bonding part of the inner membrane fold part.
Further, at least one pulling belt is arranged between the outer membrane and the inner membrane, so that the outer membrane pulls the inner membrane when the filling sac cavity is filled, and a hollow channel for circulating blood flow is formed between the inner membrane and the catheter.
Further, the medicament is a smooth muscle proliferation medicament.
Further, after the filling sac cavity is filled, the arc length occupied by the fixed connecting part on the outer wall of the inner membrane corresponds to a central angle of less than 180 degrees.
After the technical scheme is adopted, the method for filling the capsule cavity through staged expansion can ensure the integrity of effective dose when the antiproliferative drug reaches the target position through the release mode of the drug-carrying cavity on the outer membrane, and simultaneously, the formation of the hollow channel after filling can ensure that the balloon is expanded to benefit from allowing blood flow to pass and correspondingly increase the drug release time so as to increase the drug wall-sticking rate, so that the anti-smooth muscle cell proliferation drug can be fully dosed and stuck on the wall for a full time, the drug action maximization is achieved, the risk of restenosis of the coronary stent is remarkably relieved, and the pain and the family burden of a patient are effectively relieved.
Drawings
Fig. 1 is a schematic structural view of a drug-loaded balloon apparatus of the present invention before filling of the filling lumen;
fig. 2 is a schematic structural view of the drug-loaded balloon apparatus of the present invention after filling the filling lumen;
FIG. 3 is a schematic structural diagram of an inner membrane wrinkle part according to the present invention;
fig. 4 is a schematic structural view of the outer film fold portion of the present invention.
Detailed Description
In order that the present invention may be more readily and clearly understood, a more particular description of the invention briefly described above will be rendered by reference to specific embodiments that are illustrated in the appended drawings.
As shown in fig. 1-4, a drug-loaded balloon apparatus comprises:
a conduit (01);
the inner membrane 05 is positioned on the radial outer side of the catheter 01, a fixed connecting part 02 is arranged on the inner membrane 05, at least a moving part is arranged on the rest part of the inner membrane 05 except the fixed connecting part 02, and the fixed connecting part 02 is fixedly connected with the outer wall of the catheter 01;
an outer membrane 06, an filling sac is formed between the outer membrane 06 and the inner membrane 05, and at least one medicine-carrying cavity which is formed before the filling sac is not filled, carries the medicine 062 and is unfolded after the filling sac is filled so as to separate the carried medicine 062 is arranged on the outer wall of the outer membrane 06; wherein the content of the first and second substances,
the displacement portion is displaced radially outwardly of the catheter 01 during filling of the filling lumen to form a hollow passageway 08 between the filling lumen and the catheter 01 to facilitate blood flow therethrough when the filling lumen is fully filled.
As shown in fig. 1 and 2, the drug-loaded balloon apparatus further comprises a filling channel 03, wherein the filling channel 03 is connected with the filling balloon cavity so as to inject a medium into the filling balloon cavity through the filling channel 03.
As shown in fig. 2, an inlet of the filling channel 03 is provided with a filling valve 04, and an outlet of the filling channel 03 is provided at the fixed connection part 02 and is communicated with the filling capsule cavity.
In particular, the filling channel 03 may be embedded on the inner wall of the catheter 01.
As shown in fig. 4, the drug-loading chamber includes two outer membrane folds 063 disposed opposite to the outer wall of the outer membrane 06:
the radial inner sides of the two outer membrane fold parts 063 are connected;
the radially outer sides of the two outer membrane folds 063 form an opening 061 adapted to be adhesively closed prior to filling of the cavity and separated after filling of the cavity.
As shown in fig. 4, the outer membrane folds 063 are adhesively closed prior to filling the lumen and separated after filling the lumen, at least at locations adjacent the openings 061.
As shown in fig. 1, at least part of the displacement portion is adhered to the outer wall of the catheter 01 closed before the filling lumen is not filled and detached from the outer wall of the catheter 01 after the filling lumen is filled.
In particular, at least part of the moving part before filling of the cavity comprises:
a catheter bonding portion 051 adapted to bond with the catheter 01;
the radial outer sides of the two inner membrane folded parts 052 are connected, and the radial inner sides of the two inner membrane folded parts 052 are respectively connected with corresponding conduit bonding parts 051;
the intimal plication 052 is adhesively closed prior to filling of the filling lumen and separated after filling of the filling lumen, at least at a location proximal to the opening 061.
Specifically, the moving part may be formed of a catheter bonding part 051 and two inner membrane folding parts 052 which are continuously provided.
Specifically, the inner membrane pleats 052 are loosely coupled at a location proximate the opening 061.
In particular, a strip-like structure may be formed for the loose connection between the conduit bond 051 and the conduit 01.
Specifically, the adhesive force at the opening 061 < the adhesive force of the outer membrane fold portion 063 < the adhesive force of the catheter bond 051 and the catheter 01 < the adhesive force of the inner membrane fold portion 052, so that the opening 061, the outer membrane fold portion 063, the adhesive portion between the catheter bond 051 and the catheter 01, and the inner membrane fold portion 052 are sequentially released during filling of the filling lumen.
The opening 061, the outer membrane fold portion 063, the bonding portion between the catheter bonding portion 051 and the catheter 01, and the bonding portion of the inner membrane fold portion 052 are bonded by sodium hyaluronate.
Specifically, as shown in fig. 1 and 2, at least one pulling belt 07 is disposed between the outer film 06 and the inner film 05.
The medicament 062 includes, but is not limited to, smooth muscle proliferation medicament.
Specifically, after the filling cavity is filled, the central angle corresponding to the arc length occupied by the fixed connection part 02 on the outer wall of the inner membrane 05 is less than 180 degrees; preferably, < 90 °.
In the initial stage of filling of the filling sac, along with the gradual increase of the internal pressure of the filling sac, the adhesion at the opening 061 is firstly lost, and the medicine 062 hidden in the outer membrane fold part 063 is primarily adhered to the inner wall of the blood vessel; then, in the second stage of filling, as the balloon outer wall constructed by the outer membrane 06 extends gradually, the adhesion of the outer membrane fold parts 063 begins to fail until the outer membrane 06 is completely unfolded and the medicine 062 is fully adhered to the inner wall of the blood vessel; thirdly, in the third stage of filling, the filling sac cavity gradually increases, namely the height between the outer membrane 06 and the inner membrane 05 increases, the pulling belt 07 starts to pull the inner membrane 05 through the outer membrane 06, the adhesion between the catheter bonding part 051 and the catheter 01 fails, and the outer surface of the inner membrane 05 is gradually peeled off from the wall of the catheter 01; finally, in the final stage of filling, the pulling belt 07 reaches the initial set maximum length, namely the height between the outer membrane 06 and the inner membrane 05 is not increased any more, after the filling is continued, the bonding of the inner membrane fold portions 052 is disabled until the inner membrane 05 is completely unfolded, the inner membrane 05 and the outer membrane 06 form a group of eccentric circles, and a cavity formed by the inner membrane 05 and the catheter 01 becomes a hollow channel 08, so that blood flow is still allowed to pass after the filling of the filling capsule cavity is completed, and the ischemia symptom of the distal coronary artery is effectively relieved.
The embodiment can ensure the integrity of effective dosage when the antiproliferative drug reaches a target position through a method of inflating and filling the balloon cavity by stages and a mode of releasing the drug-carrying cavity on the outer membrane 06, and simultaneously can ensure that the balloon is benefited by allowing blood flow to pass through during expansion so as to correspondingly increase the drug release duration and increase the drug wall-sticking rate through the formation of the hollow channel after filling, so that the anti-smooth muscle cell proliferation drug can be fully dosed and stuck on the wall for a sufficient duration integrally, the drug action maximization is achieved, the risk of restenosis of the coronary stent is remarkably slowed down, and the pain and the family burden of a patient are effectively relieved.
The above embodiments are described in further detail to solve the technical problems, technical solutions and advantages of the present invention, and it should be understood that the above embodiments are only examples of the present invention and are not intended to limit the present invention, and any modifications, equivalent substitutions, improvements and the like made within the spirit and principle of the present invention should be included in the protection scope of the present invention.
In the description of the present invention, it is to be understood that the terms indicating an orientation or positional relationship are based on the orientation or positional relationship shown in the drawings only for the convenience of describing the present invention and simplifying the description, and do not indicate or imply that the device or element referred to must have a specific orientation, be constructed and operated in a specific orientation, and thus, should not be construed as limiting the present invention.
In the present invention, unless otherwise expressly stated or limited, the terms "mounted," "connected," "secured," and the like are to be construed broadly and can, for example, be fixedly connected, detachably connected, or integrally formed; can be mechanically or electrically connected; either directly or indirectly through intervening media, either internally or in any other relationship. The specific meanings of the above terms in the present invention can be understood by those skilled in the art according to specific situations.
In the description of the present invention, it should be noted that the terms "center", "upper", "lower", "left", "right", "vertical", "horizontal", "inner", "outer", etc. indicate orientations or positional relationships based on the orientations or positional relationships shown in the drawings or the orientations or positional relationships that the products of the present invention are conventionally placed in use, and are only used for convenience in describing the present invention and simplifying the description, but do not indicate or imply that the devices or elements referred to must have a specific orientation, be constructed and operated in a specific orientation, and thus, should not be construed as limiting the present invention. Furthermore, the terms "first," "second," "third," and the like are used solely to distinguish one from another and are not to be construed as indicating or implying relative importance.
Furthermore, the terms "horizontal", "vertical", "overhang" and the like do not imply that the components are required to be absolutely horizontal or overhang, but may be slightly inclined. For example, "horizontal" merely means that the direction is more horizontal than "vertical" and does not mean that the structure must be perfectly horizontal, but may be slightly inclined.
In the present invention, unless otherwise expressly stated or limited, the first feature may be present on or under the second feature in direct contact with the first and second feature, or may be present in the first and second feature not in direct contact but in contact with another feature between them. Also, the first feature being above, on or above the second feature includes the first feature being directly above and obliquely above the second feature, or merely means that the first feature is at a higher level than the second feature. A first feature that underlies, and underlies a second feature includes a first feature that is directly under and obliquely under a second feature, or simply means that the first feature is at a lesser level than the second feature.
Claims (12)
1. A drug-loaded balloon apparatus, comprising:
a catheter (01);
the inner membrane (05) is positioned on the radial outer side of the catheter (01), a fixed connecting part (02) is arranged on the part of the inner membrane (05), at least a moving part is arranged on the remaining part of the inner membrane (05) except the fixed connecting part (02), and the fixed connecting part (02) is fixedly connected with the outer wall of the catheter (01);
an outer membrane (06), wherein an filling cavity is formed between the outer membrane (06) and the inner membrane (05), and at least one medicine-carrying cavity which is formed before the filling cavity is not filled, carries the medicine (062) and is unfolded after the filling cavity is filled so as to separate the carried medicine (062) is arranged on the outer wall of the outer membrane (06); wherein the content of the first and second substances,
the displacement portion is displaced radially outwards of the catheter (01) during filling of the filling lumen to form a hollow passage (08) between the filling lumen and the catheter (01) to facilitate blood flow therethrough when the filling lumen is fully filled.
2. The pre-loaded balloon apparatus of claim 1,
still include filling passageway (03), filling passageway (03) with filling the cyst intracavity links to each other, with through filling passageway (03) to filling the intracavitary injection medium of cyst.
3. The pre-loaded balloon apparatus of claim 2,
the entry of filling passageway (03) is equipped with sufficient valve (04), the export of filling passageway (03) is located fixed connection portion (02) department, and with sufficient bag chamber is linked together.
4. The pre-loaded balloon apparatus of claim 1,
the drug carrying cavity comprises two outer membrane fold parts (063) arranged on the outer wall of the outer membrane (06) oppositely:
the radial inner sides of the two outer membrane fold parts (063) are connected;
the radially outer sides of the two outer membrane folds (063) form an opening (061) adapted to be adhesively closed prior to filling of the cavity and separated after filling of the cavity.
5. The pre-loaded balloon apparatus of claim 4,
the outer membrane fold (063) is adhesively closed prior to filling the lumen and separated after filling the lumen, at least at a location adjacent the opening (061).
6. The pre-loaded balloon apparatus of claim 1,
at least part of the displacement portion is adhered to the outer wall of the catheter (01) closed before the filling lumen is not filled and separated from the outer wall of the catheter (01) after the filling lumen is filled.
7. The pre-loaded balloon apparatus of claim 6,
at least a portion of the mobile portion prior to filling of a lumen comprises:
a catheter bonding portion (051) adapted to bond with the catheter (01);
the radial outer sides of the two inner membrane folded parts (052) are connected, and the radial inner sides of the two inner membrane folded parts (052) are respectively connected with the corresponding conduit bonding parts (051);
the intimal fold (052) is adhesively closed prior to filling of the filling lumen and separated after filling of the filling lumen, at least at a location adjacent the opening (061).
8. The pre-loaded balloon apparatus of claim 5,
at least a portion of the mobile portion prior to filling of a lumen comprises:
a catheter bonding portion (051) adapted to bond with the catheter (01);
the radial outer sides of the two inner membrane folded parts (052) are connected, and the radial inner sides of the two inner membrane folded parts (052) are respectively connected with the corresponding conduit bonding parts (051);
the intimal fold (052) being adhesively closed prior to filling of the cavity and being separated after filling of the cavity, at least at a location adjacent the opening (061);
adhesion at the opening (061) < adhesion of the outer membrane fold (063) < adhesion of the catheter bond (051) to the catheter (01) < adhesion of the inner membrane fold (052), such that during filling of the filling balloon, the opening (061), the outer membrane fold (063), the adhesion between the catheter bond (051) and the catheter (01), and the inner membrane fold (052) disengage in sequence.
9. The pre-loaded balloon apparatus of claim 8,
the opening (061) and/or the outer membrane fold (063) and/or the bond between the catheter bond (051) and the catheter (01) and/or the bond of the inner membrane fold (052) are bonded using sodium hyaluronate.
10. The pre-loaded balloon apparatus of claim 1,
at least one drawing belt (07) is arranged between the outer membrane (06) and the inner membrane (05).
11. The pre-loaded balloon apparatus of claim 1,
the medicine (062) is a smooth muscle proliferation medicine.
12. The pre-loaded balloon apparatus of claim 1,
after the filling sac cavity is filled, the arc length occupied by the fixed connecting part (02) on the outer wall of the inner membrane (05) corresponds to a central angle of less than 180 degrees.
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Citations (7)
Publication number | Priority date | Publication date | Assignee | Title |
---|---|---|---|---|
US5792300A (en) * | 1994-01-21 | 1998-08-11 | Cordis Corporation | Perfusion catheter and striped extrusion method of manufacture |
CN103260692A (en) * | 2010-12-21 | 2013-08-21 | 因瓦泰克技术中心有限公司 | Drug eluting balloon for the treatment of stenosis and method for manufacturing the balloon |
US20150272732A1 (en) * | 2012-10-18 | 2015-10-01 | Loma Vista Medical, Inc. | Reinforced inflatable medical devices |
CN107551385A (en) * | 2017-07-03 | 2018-01-09 | 上海心至医疗科技有限公司 | A kind of newtype drug sacculus and preparation method thereof |
US20190175880A1 (en) * | 2014-12-23 | 2019-06-13 | C.R. Bard, Inc. | Inflatable medical device and related sheath |
US20190321602A1 (en) * | 2018-04-23 | 2019-10-24 | Daniel Ezra Walzman | Bulging Torus Balloon |
CN212730680U (en) * | 2020-03-30 | 2021-03-19 | 上海瑟湃智能科技有限公司 | Drug-loaded balloon apparatus |
-
2020
- 2020-03-30 CN CN202010237704.6A patent/CN111388842B/en active Active
Patent Citations (7)
Publication number | Priority date | Publication date | Assignee | Title |
---|---|---|---|---|
US5792300A (en) * | 1994-01-21 | 1998-08-11 | Cordis Corporation | Perfusion catheter and striped extrusion method of manufacture |
CN103260692A (en) * | 2010-12-21 | 2013-08-21 | 因瓦泰克技术中心有限公司 | Drug eluting balloon for the treatment of stenosis and method for manufacturing the balloon |
US20150272732A1 (en) * | 2012-10-18 | 2015-10-01 | Loma Vista Medical, Inc. | Reinforced inflatable medical devices |
US20190175880A1 (en) * | 2014-12-23 | 2019-06-13 | C.R. Bard, Inc. | Inflatable medical device and related sheath |
CN107551385A (en) * | 2017-07-03 | 2018-01-09 | 上海心至医疗科技有限公司 | A kind of newtype drug sacculus and preparation method thereof |
US20190321602A1 (en) * | 2018-04-23 | 2019-10-24 | Daniel Ezra Walzman | Bulging Torus Balloon |
CN212730680U (en) * | 2020-03-30 | 2021-03-19 | 上海瑟湃智能科技有限公司 | Drug-loaded balloon apparatus |
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