CN115779241B - Drug balloon system - Google Patents
Drug balloon system Download PDFInfo
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- CN115779241B CN115779241B CN202211461619.3A CN202211461619A CN115779241B CN 115779241 B CN115779241 B CN 115779241B CN 202211461619 A CN202211461619 A CN 202211461619A CN 115779241 B CN115779241 B CN 115779241B
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- 239000003814 drug Substances 0.000 title claims abstract description 124
- 229940079593 drug Drugs 0.000 title claims abstract description 73
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- 210000005077 saccule Anatomy 0.000 claims abstract description 7
- 230000000149 penetrating effect Effects 0.000 claims abstract description 4
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Abstract
The invention provides a medicine balloon system, which comprises a tip, an inner tube, a balloon, a sleeve, a protection component and a cutting medicine storage component, wherein the tip is provided with a first end and a second end; the distal end of the inner tube is connected with the tip, and the interior of the inner tube is communicated with the interior of the tip and forms a guide channel for the penetration of a guide wire; the balloon is sleeved on the inner tube, the far end of the balloon is fixedly connected to the inner tube, the near end of the balloon is connected with the sleeve, the sleeve is sleeved on the inner tube, and a gap channel for a liquid medium to flow into the balloon is arranged between the sleeve and the inner tube; the protection component is movably sleeved on the sleeve; the cutting medicine storage component is arranged on the saccule and used for cutting and penetrating into a blood vessel, and a medicine storage groove is arranged on the cutting medicine storage component; the balloon and the cutting medicine storage component are stored in the protection component by driving the protection component to move towards the tip. The drug balloon system can reduce the drug loss in the intervention process and improve the utilization rate of the drug after being adhered to the wall.
Description
Technical Field
The invention relates to the technical field of medical instruments, in particular to a drug balloon system.
Background
Vascular intervention is an important therapeutic modality for the revascularization of stenotic lesions, where restenosis is usually caused by proliferation of smooth muscle cells in the media.
In recent years, new devices and therapeutic strategies have been developed to overcome the above problems, and a drug-coated balloon, which is a product of a combination of conventional balloon-forming and advanced drug eluting techniques, is gradually showing its superiority as an effective supplement to stent-forming. The DCB (drug coated balloon Drug Coating Balloon, DCB) not only is simple and convenient to operate, but also has unique advantages for restenosis, bifurcation lesions, small vascular lesions, severe bending calcification lesions and the like in stents. However, DCB still has the problems of serious loss of the balloon surface drug during the intervention process, short contact time with the vessel wall, low drug utilization efficiency, and the like.
In addition, since atherosclerosis is the pathological basis for causing acute cardiovascular events, the main cause of the acute cardiovascular events is local atherosclerotic plaque rupture and thrombosis, and the thrombosis depends on the vulnerability of the atherosclerotic plaque, which is easy to cause plaque rupture and thrombosis, thereby causing acute coronary syndrome to occur. On one hand, platelets are easily activated by naked lipid in unstable plaque to form micro-thrombosis which is adhered and aggregated at lesion vascular sites to cause microcirculation obstruction under the extrusion action of a saccule or a stent after the stent is put in; on the other hand, thrombus is easy to fracture and fall off in the treatment process, so that the thrombus fragments flow to the distal end of the coronary artery, and the distal end blood vessel is blocked, thereby the phenomenon of slow blood flow occurs. With the increase of the blocking quantity, the remote blood vessel is completely re-blocked, namely, no reflow phenomenon appears, and finally the risks of congestive heart failure, malignant arrhythmia and cardiac death are increased, so that the difficulty of interventional therapy is increased, the occurrence rate of cardiovascular events is increased, the curative effect of PCI is seriously influenced, and the death rate of AMI patients is increased.
Therefore, it is desirable to provide a drug balloon system to reduce drug loss during intervention and improve drug utilization after wall expansion.
Disclosure of Invention
The invention aims to provide a medicine balloon system so as to reduce medicine loss in an intervention process and improve the utilization rate of medicine after being adhered to a wall.
In order to achieve the above object, the present invention provides a drug balloon system, comprising a tip, an inner tube, a balloon, a sleeve, a protection component and a cutting drug storage component; the distal end of the inner tube is connected with the tip, and the interior of the inner tube is communicated with the interior of the tip and forms a guide channel for the penetration of a guide wire; the balloon is sleeved on the inner tube, the far end of the balloon is fixedly connected to the inner tube, the near end of the balloon is connected with the sleeve, the sleeve is sleeved on the inner tube, and a gap channel for a liquid medium to flow into the balloon is arranged between the sleeve and the inner tube; the protection component is movably sleeved on the sleeve; the cutting medicine storage component is arranged on the saccule and is used for cutting and penetrating into a blood vessel, and a medicine storage groove is formed in the cutting medicine storage component; the balloon and the cutting medicine storage component are stored in the protection component by driving the protection component to move towards the direction of the tip.
Preferably, the drug balloon system further comprises a Y-shaped needle seat, the proximal end of the inner tube is inserted into the straight cavity of the Y-shaped needle seat, the proximal end of the sleeve is inserted into the straight cavity of the Y-shaped needle seat, and the clearance channel is communicated with the Y-shaped cavity of the Y-shaped needle seat.
Preferably, the protection assembly comprises an outer sheath tube and a Y valve assembly, the outer sheath tube is movably sleeved on the sleeve, the proximal end of the outer sheath tube is connected with the distal end of the Y valve assembly, and the Y valve assembly is sleeved on the sleeve.
Preferably, the drug balloon system further comprises a capturing net component, wherein the capturing net component is sleeved on the sleeve and is positioned between the balloon and the outer sheath, and the outer sheath is driven to move towards the tip direction by the Y-valve component so as to store the capturing net component, the balloon and the cutting drug storage component in the outer sheath.
Preferably, the drug balloon system further comprises an intermediate sheath movably sleeved on the sleeve and positioned between the outer sheath and the sleeve, and the distal end of the intermediate sheath is connected with the capturing net assembly; the position of the capture net assembly is adjusted by actuating the intermediate sheath to move.
Preferably, the capturing net assembly comprises a capturing net body and a capturing net fixing ring, wherein the proximal end of the capturing net body is connected with the capturing net fixing ring, and the capturing net fixing ring is connected with the distal end of the intermediate sheath tube.
Preferably, the capturing net body is provided with a plurality of micropore structures, and the micropore structures are used for allowing normal blood to pass through so as to intercept medicines.
Preferably, the drug balloon system further comprises a regulator, the proximal end of the intermediate sheath is connected with the regulator, and the regulator is sleeved on the sleeve.
Preferably, the cutting medicine storage component comprises a cutting wire and a constraint wire, the cutting wire is arranged on the balloon along the axial direction of the balloon, the constraint wire is wound on the balloon along the radial direction of the balloon, and the medicine storage grooves are distributed on the constraint wire.
Preferably, the plurality of cutting wires are uniformly distributed on the balloon along the radial direction of the balloon, the proximal end of the balloon is provided with a proximal end fixing ring connected with the proximal end of the cutting wire, and the distal end of the balloon is provided with a distal end fixing ring connected with the distal end of the cutting wire; the plurality of constraint wires are distributed on the balloon at equal intervals along the circumferential direction of the balloon, and the cutting wires and the constraint wires are fixedly connected together in a crossing way.
Compared with the prior art, the drug balloon system has the advantages that the protective component is arranged on the sleeve, and the protective component is driven to move towards the tip, so that the balloon and the cutting drug storage component are stored in the protective component, further, the drug loss of the drug balloon system in the intervention process can be reduced, and the cutting drug storage component is prevented from damaging the normal vascular part; through order about protection component to keep away from the direction of pointed end removes, can make again that the original collection is in protection component's inside sacculus with the cutting medicine storage subassembly breaks away from outside constraint, injects liquid medium to the sacculus through the clearance passageway, expands the sacculus, and the medicine in the storing groove of cutting medicine storage subassembly can release, simultaneously, and the cutting medicine storage subassembly can cut and pierce pathological change position, can go deep into pathological change vascular medium membrane, improves the medicine utilization ratio. Therefore, the drug balloon system of the invention can reduce the drug loss in the interventional process and improve the utilization rate of the drug after the wall is dilated.
Drawings
Fig. 1 is a block diagram of a drug balloon system of the present invention.
Fig. 2 is a cross-sectional view of the drug balloon system of the present invention at the location of the Y-hub.
Fig. 3 is a block diagram of the drug balloon system of the present invention at the point of the tip to the outer sheath.
Fig. 4 is a block diagram of a balloon and cutting drug storage assembly of the present invention.
Fig. 5 is an enlarged view at a in fig. 4.
Fig. 6 is a cross-sectional view of the drug balloon system of the present invention at the location of the capture net assembly.
Detailed Description
In order to describe the technical content and constructional features of the present invention in detail, the following description will be made with reference to the embodiments in conjunction with the accompanying drawings.
In this document, "proximal" and "distal" are relative orientations, relative positions, and relative directions of elements or actions relative to one another from the perspective of a physician using the medical device, although "proximal" and "distal" are not intended to be limiting, and "proximal" generally refers to an end of the medical device that is proximal to the physician during normal operation, and "distal" generally refers to an end that first enters the patient.
Referring to fig. 1 to 5, the drug balloon system 100 of the present invention includes a tip 1, an inner tube 2, a balloon 3, a sleeve 4, a protection component 5, and a cutting drug storage component 6; the distal end of the inner tube 2 is connected to the tip 1, and the interior of the inner tube 2 communicates with the interior of the tip 1 and forms a guide channel 7 for guiding the penetration of a guide wire; the balloon 3 is sleeved on the inner tube 2, the distal end of the balloon 3 is fixedly connected to the inner tube 2, the proximal end of the balloon 3 is connected with the sleeve 4, the sleeve 4 is sleeved on the inner tube 2, and a gap channel 8 for liquid medium to flow into the balloon 3 is arranged between the sleeve 4 and the inner tube 2; the protection component 5 is movably sleeved on the sleeve 4; the cutting medicine storage component 6 is arranged on the saccule 3, the cutting medicine storage component 6 is used for cutting and penetrating into a blood vessel, and a medicine storage groove 621 is arranged on the cutting medicine storage component 6; the balloon 3 and the cutting medicine storage component 6 are stored in the protection component 5 by driving the protection component 5 to move towards the tip 1. The tip 1 may be connected to the inner tube 2 by a UV bonding process, the proximal end of the balloon 3 is connected to the sleeve 4 by laser welding, and the distal end of the balloon 3 is connected to the inner tube 2 by laser welding, but not limited thereto.
Referring to fig. 1 and 2, in the present embodiment, the drug balloon system 100 further includes a Y-shaped needle holder 9, the proximal end of the inner tube 2 is inserted into the straight cavity 91 of the Y-shaped needle holder 9, the proximal end of the sleeve 4 is inserted into the straight cavity 91 of the Y-shaped needle holder 9, and the gap channel 8 is communicated with the Y-shaped cavity 92 of the Y-shaped needle holder 9. Specifically, the depth of the inner tube 2 inserted into the straight cavity 91 of the Y-shaped needle seat 9 is deeper than the depth of the sleeve 4 inserted into the straight cavity 91 of the Y-shaped needle seat 9, and the proximal end of the sleeve 4 is located at a position close to the Y-shaped cavity 92 of the Y-shaped needle seat 9, so that the clearance channel 8 is communicated with the Y-shaped cavity 92 of the Y-shaped needle seat 9, a doctor can conveniently inject liquid medium through the Y-shaped cavity 92 of the Y-shaped needle seat 9, and the liquid medium can flow into the balloon 3 through the clearance channel 8, so that the balloon 3 is expanded.
Referring to fig. 1, in the present embodiment, the protection assembly 5 includes an outer sheath 51 and a Y valve assembly 52, the outer sheath 51 is movably sleeved on the sleeve 4, a proximal end of the outer sheath 51 is connected to a distal end of the Y valve assembly 52, and the Y valve assembly 52 is sleeved on the sleeve 4. The doctor can drive the outer sheath tube 51 to move towards the direction close to the tip 1 (namely the direction of the distal end) through the Y-valve assembly 52, so that the balloon 3 and the cutting medicine storage assembly 6 are stored in the outer sheath tube 51, and further the medicine loss of the medicine balloon system 100 in the interventional process can be reduced; the physician may move the outer sheath 51 away from the tip 1 (i.e., proximally) through the Y-valve assembly 52, and may also disengage the balloon 3, which was originally housed within the protective assembly 5, and the cutting drug storage assembly 6 from the external restraint. The proximal end of the outer sheath 51 may be connected to the distal end of the Y valve assembly 52 by a UV bonding process, but is not limited thereto.
Referring to fig. 1, 3 and 6, the drug balloon system 100 of the present invention further includes a capturing net assembly 10, wherein the capturing net assembly 10 is sleeved on the sleeve 4 and located between the balloon 3 and the outer sheath 51, and the outer sheath 51 is driven to move towards the tip 1 by the Y valve assembly 52 to store the capturing net assembly 10, the balloon 3 and the cutting drug storage assembly 6 in the outer sheath 51. The outer sheath 51 is urged by the Y-valve assembly 52 in a direction toward the tip 1 (i.e., in a distal direction) to stow the capture net assembly 10 within the outer sheath 51 for convenient intervention by a physician in the lesion of the patient using the drug balloon system 100 of the present invention; the Y-valve assembly 52 drives the outer sheath 51 to move away from the tip 1 (i.e., in the proximal direction), so that the capture net assembly 10 originally stored in the outer sheath 51 is released, the capture net assembly 10 is used for capturing thrombus plaque, plaque generated in the operation process is prevented from flowing to a normal vascular site, and the plaque can be pumped out of the body.
Referring to fig. 1, the drug balloon system 100 of the present invention further comprises an intermediate sheath 11, wherein the intermediate sheath 11 is movably sleeved on the cannula 4 and is located between the outer sheath 51 and the cannula 4, and the distal end of the intermediate sheath 11 is connected with the capturing net assembly 10; the position of the capture net assembly 10 is adjusted by actuating the intermediate sheath 11. Further, the drug balloon system 100 of the present invention further comprises a regulator 12, the proximal end of the intermediate sheath 11 is connected to the regulator 12, and the regulator 12 is sleeved on the cannula 4. The position of the capture net assembly 10 is adjusted by setting the adjuster 12 so that the physician drives the movement of the intermediate sheath 11 through the adjuster 12.
Referring to fig. 6, in the present embodiment, the capturing net assembly 10 includes a capturing net body 101 and a capturing net fixing ring 102, wherein a proximal end of the capturing net body 101 is connected to the capturing net fixing ring 102, the capturing net fixing ring 102 is connected to a distal end of the intermediate sheath 11, and a proximal end of the intermediate sheath 11 is connected to the regulator 12. The proximal end of the capturing net body 101 may be fixed on the capturing net fixing ring 102 by a laser welding process, the distal end of the middle sheath 11 is connected with the capturing net fixing ring 102 by glue, and the proximal end of the middle sheath 11 is connected with the regulator 12 by a UV bonding process, but not limited thereto. Further, the capturing net body 101 is provided with a plurality of micro-porous structures (not shown) for allowing normal blood to pass therethrough and intercepting the medicine. The medicine is intercepted by allowing normal blood to pass through the micropore structure on the capturing net body 101, so that the medicine concentration of a lesion part is ensured, and the medicine utilization rate is improved.
Referring to fig. 3 to 5, in the present embodiment, the cutting drug storage assembly 6 includes a cutting wire 61 and a constraining wire 62, the cutting wire 61 is disposed on the balloon 3 along the axial direction of the balloon 3, the constraining wire 62 is wound on the balloon 3 along the radial direction of the balloon 3, and the drug storage grooves 621 are distributed on the constraining wire 62. Specifically, the plurality of cutting wires 61 are uniformly distributed on the balloon 3 along the radial direction of the balloon 3, the proximal end of the balloon 3 is provided with a proximal end fixing ring 31 connected with the proximal end of the cutting wires 61, and the distal end of the balloon 3 is provided with a distal end fixing ring 32 connected with the distal end of the cutting wires 61; the plurality of constraint wires 62 are distributed on the balloon 3 at equal intervals along the circumferential direction of the balloon 3, and the cutting wires 61 and the constraint wires 62 are fixedly connected together in a crossing way to form a constraint cage body. The intersection between the cutting wire 61 and the constraining wire 62 is connected by laser welding, the proximal end of the cutting wire 61 is connected with the proximal end fixing ring 31 by laser welding, and the distal end of the cutting wire 61 is connected with the distal end fixing ring 32 by laser welding, but not limited thereto. After the liquid medium is injected through the Y-shaped cavity 92 of the Y-shaped needle seat 9, the liquid medium can flow into the balloon 3 through the clearance channel 8, so that the balloon 3 is expanded, and at the moment, the balloon 3 can be expanded under the constraint condition due to the actions of the external cutting wire 61 and the constraint wire 62, so that the damage to the blood vessel wall is reduced, meanwhile, the medicine in the medicine storage groove 621 can be released, the cutting wire 61 can also penetrate into the blood vessel wall, and the permeation effect of the medicine is improved.
Referring to fig. 1 to 6, the specific working principle of the drug balloon system 100 of the present invention is as follows:
the guide wire passes through the catheter sheath set to reach the predetermined lesion of the blood vessel, and the drug balloon system 100 of the present invention passes through the guide wire to reach the predetermined lesion of the blood vessel. The movement of the Y-valve assembly 52 drives the proximal movement of the outer sheath 51, freeing the balloon 3 from external restraint, while releasing the capture net assembly 10. Then, the balloon 3 is expanded by injecting a liquid medium into the Y-cavity 92 of the Y-hub 9, and at this time, the balloon 3 is expanded under the constraint condition due to the external cutting wire 61 and the constraint wire 62, thereby reducing the damage to the vessel wall. Simultaneously, the medicine in the medicine storage groove 621 can be released, and the cutting wire 61 can penetrate into the inner part of the blood vessel wall, so that the permeation effect of the medicine is improved. During operation of the balloon 3 and the medicament, the capture net body 101 of the capture net assembly 10 captures plaque generated during this process at the proximal end, and intercepts medicament flushed from the blood stream. In addition, the position of the capture net assembly 10 can be adjusted by the adjuster 12 during this process to better capture plaque and medications. After the balloon 3 finishes the work, the balloon 3 is decompressed through the Y-shaped cavity 92 of the Y-shaped needle seat 9. The outer sheath 51 is then moved distally by moving the Y-valve assembly 52, folding the capture net assembly 10, balloon 3, and cut drug storage assembly 6, thereby stowing the capture net assembly 10, balloon 3, and cut drug storage assembly 6 within the outer sheath 51, and pushing the drug balloon system 100 out of the body.
In summary, the drug balloon system 100 of the invention is characterized in that the protective component 5 is arranged on the sleeve 4, and the protective component 5 is driven to move towards the direction of the tip 1, so that the balloon 3 and the cutting drug storage component 6 are stored in the protective component 5, thereby reducing the drug loss of the drug balloon system 100 in the interventional process and preventing the cutting drug storage component 6 from damaging the normal vascular part; through driving the protection component 5 to move towards the direction away from the tip 1, the balloon 3 and the cutting medicine storage component 6 which are originally collected in the protection component 5 can be separated from external constraint, liquid medium is injected into the balloon 3 through the clearance channel 8 to expand the balloon 3, medicines in the storage groove of the cutting medicine storage component 6 can be released, meanwhile, the cutting medicine storage component 6 can cut and pierce a lesion part, and can penetrate into the middle membrane of a lesion blood vessel, so that the utilization rate of the medicines is improved. The drug balloon system 100 of the present invention also prevents plaque generated during surgery from flowing to normal vascular sites while simultaneously evacuating plaque from the body by providing the capture net assembly 10 on the proximal side of the balloon 3. In addition, the capturing net body 101 of the capturing net assembly 10 is further provided with a microporous structure, and the medicine can be intercepted by using the microporous structure to allow normal blood to pass through, so that the medicine concentration of a lesion part is ensured, and the medicine utilization rate is improved.
The foregoing disclosure is only illustrative of the preferred embodiments of the present invention and is not to be construed as limiting the scope of the invention, which is defined by the appended claims.
Claims (8)
1. A drug balloon system, which is characterized by comprising a tip, an inner tube, a balloon, a sleeve, a protection component, a cutting drug storage component and a capturing net component; the distal end of the inner tube is connected with the tip, and the interior of the inner tube is communicated with the interior of the tip and forms a guide channel for the penetration of a guide wire; the balloon is sleeved on the inner tube, the far end of the balloon is fixedly connected to the inner tube, the near end of the balloon is connected with the sleeve, the sleeve is sleeved on the inner tube, and a gap channel for a liquid medium to flow into the balloon is arranged between the sleeve and the inner tube; the protection component is movably sleeved on the sleeve; the cutting medicine storage component is arranged on the saccule and is used for cutting and penetrating into a blood vessel, and a medicine storage groove is formed in the cutting medicine storage component; the balloon and the cutting medicine storage component are stored in the protection component by driving the protection component to move towards the direction of the tip; the protection assembly comprises an outer sheath tube and a Y-valve assembly, the outer sheath tube is movably sleeved on the sleeve, the proximal end of the outer sheath tube is connected with the distal end of the Y-valve assembly, and the Y-valve assembly is sleeved on the sleeve; the catching net component is sleeved on the sleeve and is positioned between the saccule and the outer sheath, and the Y-shaped valve component drives the outer sheath to move towards the direction of the tip so as to collect the catching net component, the saccule and the cutting medicine storage component in the outer sheath.
2. The drug balloon system of claim 1, further comprising a Y-hub, wherein the proximal end of the inner tube is inserted into the straight cavity of the Y-hub, the proximal end of the sleeve is inserted into the straight cavity of the Y-hub, and the clearance channel is in communication with the Y-cavity of the Y-hub.
3. The drug balloon system of claim 1, further comprising an intermediate sheath movably sleeved over the cannula and positioned between the outer sheath and the cannula, a distal end of the intermediate sheath being connected to the capture net assembly; the position of the capture net assembly is adjusted by actuating the intermediate sheath to move.
4. A drug balloon system according to claim 3 and wherein said capture net assembly comprises a capture net body and a capture net retaining ring, said capture net body proximal end being connected to said capture net retaining ring, said capture net retaining ring being connected to said intermediate sheath distal end.
5. The drug balloon system of claim 4, wherein the capture net body is provided with a plurality of microporous structures for allowing normal blood to pass therethrough to intercept the drug.
6. The drug balloon system of claim 3, further comprising a regulator, wherein the proximal end of the intermediate sheath is coupled to the regulator and the regulator is sleeved over the cannula.
7. The drug balloon system of claim 1, wherein the cutting drug storage assembly comprises a cutting wire and a constraining wire, the cutting wire is disposed on the balloon along an axial direction of the balloon, the constraining wire is wound on the balloon along a radial direction of the balloon, and the drug storage grooves are distributed on the constraining wire.
8. The drug balloon system according to claim 7, wherein a plurality of the cutting wires are uniformly distributed on the balloon along the radial direction of the balloon, the proximal end of the balloon is provided with a proximal fixing ring connected with the proximal end of the cutting wire, and the distal end of the balloon is provided with a distal fixing ring connected with the distal end of the cutting wire; the plurality of constraint wires are distributed on the balloon at equal intervals along the circumferential direction of the balloon, and the cutting wires and the constraint wires are fixedly connected together in a crossing way.
Priority Applications (1)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| CN202211461619.3A CN115779241B (en) | 2022-11-17 | 2022-11-17 | Drug balloon system |
Applications Claiming Priority (1)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| CN202211461619.3A CN115779241B (en) | 2022-11-17 | 2022-11-17 | Drug balloon system |
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| CN115779241A CN115779241A (en) | 2023-03-14 |
| CN115779241B true CN115779241B (en) | 2024-01-19 |
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| Application Number | Title | Priority Date | Filing Date |
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| CN202211461619.3A Active CN115779241B (en) | 2022-11-17 | 2022-11-17 | Drug balloon system |
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| Publication number | Priority date | Publication date | Assignee | Title |
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| CN116271456B (en) * | 2023-05-23 | 2023-08-11 | 杭州瑞维特医疗科技有限公司 | Medicine sacculus pipe subassembly |
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| CN113081185A (en) * | 2021-04-08 | 2021-07-09 | 哈尔滨医科大学 | Thrombus cutting system |
| CN114010917A (en) * | 2021-11-05 | 2022-02-08 | 广东博迈医疗科技股份有限公司 | Double-medicine administration balloon |
| CN114796810A (en) * | 2022-04-12 | 2022-07-29 | 四川大学华西医院 | Cutting sacculus pipe of medicine carrying |
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