WO2021217697A1

WO2021217697A1 - Drug-release balloon catheter and drug release method therefor

Info

Publication number: WO2021217697A1
Application number: PCT/CN2020/089184
Authority: WO
Inventors: 刘振全; 魏征
Original assignee: 童妍(上海)医疗器械有限公司
Priority date: 2020-04-29
Filing date: 2020-05-08
Publication date: 2021-11-04
Also published as: CN111408019A

Abstract

A drug-release balloon catheter and a drug release method therefor. A second balloon of the drug-release balloon catheter comprises a first area, a second area provided at the proximal end of the first area, and a third area provided at the distal end of the first area; the first area is provided with at least one micropore; during drug release, the second balloon is in an expanded state; the diameter of the first area is smaller than the diameter of the second area and smaller than the diameter of the third area; and the second area and the third area are both attached to the inner wall of a cavity, and the first area and the inner wall of the cavity define a drug-release space.

Description

Drug-releasing balloon catheter and its drug-releasing method

Technical field

The invention relates to the technical field of medical devices, in particular to a drug-releasing balloon catheter and a drug-releasing method thereof.

Background technique

The drug-releasing balloon catheter is an emerging method for the treatment of body cavities (for example, coronary artery, blood vessel, eustachian tube, trachea, bronchus, ureter, urinary catheter, urinary tube, prostate, etc.) that has emerged in recent years. The surface of the drug-releasing balloon catheter is coated with liquid medicine. When the drug-releasing balloon catheter reaches the diseased site, the drug-releasing balloon catheter can be inflated by inflating the drug-releasing balloon catheter, thereby making the drug-releasing balloon catheter Contact with the inner wall of the cavity and exert pressure on it to open the diseased part, and the liquid medicine on the surface of the drug-releasing balloon catheter can be released to the diseased part, which has a therapeutic effect on the diseased part.

However, during the process of delivering the drug-releasing balloon catheter into the target lumen, a part of the drug solution will be lost, and in the process of being delivered to the diseased part in the target lumen, part of the drug solution on the surface of the drug-releasing balloon catheter It may be taken away by the fluid in the cavity (for example, blood, urine, air, etc.), and there is very little medicine that actually reaches the lesion. In order to completely repair the diseased part, a large dose or multiple doses are required. This may increase the economic burden of the patient, and the lost liquid medicine may block the cavity and/or increase the body's metabolic burden.

Summary of the invention

The purpose of the present invention is to provide a drug-releasing balloon catheter and a drug-releasing method thereof, which can prevent or reduce the loss of liquid medicine and realize precise drug delivery.

To achieve this goal, the present invention adopts the following technical solutions:

A drug-releasing balloon catheter. The drug-releasing balloon catheter includes a first balloon, a second balloon, and a first channel and a second channel that are isolated from each other. The second balloon is sleeved on the first balloon In addition, the internal space of the first balloon constitutes a first chamber, the space between the first balloon and the second balloon constitutes a second chamber, and the first channel is connected to the first chamber. The chamber is in communication, the second passage is in communication with the second chamber, the pressurized fluid is delivered to the first chamber through the first passage, or is drawn out from the first chamber, and the liquid medicine The second balloon is delivered to the second chamber through the second channel, or is withdrawn from the second chamber. The second area and the third area arranged at the distal end of the first area. The first area is provided with at least one micropore. When the drug is released, the second balloon is in an inflated state. The diameter is smaller than the diameter of the second area and smaller than the diameter of the third area, the second area and the third area are both attached to the inner wall of the cavity, and the first area surrounds the inner wall of the cavity. Together to form a drug release space.

In one of the embodiments, the first balloon is a semi-compliant balloon or a non-compliant balloon.

In one of the embodiments, the second balloon is a compliant balloon or a semi-compliant balloon or a non-compliant balloon.

In one of the embodiments, the first balloon and the second balloon are both in a folded state before use.

In one of the embodiments, the pressurized fluid is delivered into the first cavity through the first channel, so that when the first balloon is inflated, the first balloon expands and supports the cavity road.

In one of the embodiments, when the first balloon is in an inflated state, the middle part of the first balloon is a working section for expanding and supporting the cavity, and the shape of the working section is the same as The shape of the cavity matches.

In one of the embodiments, the working section is cylindrical, the outer diameter of the working section is 1-30 mm, and the length of the working section is 5-300 mm.

In one of the embodiments, when the second balloon is in an inflated state, the diameter of the first area is 0.1%-50% smaller than the diameter of the second area, and/or the diameter of the first area It is 0.1%-50% smaller than the diameter of the third region.

In one of the embodiments, the porosity of the micropores in the first region is 2%-80%.

In one of the embodiments, the first area is composed of a first surface, a second surface, and a third surface. The second surface is inclined inwardly from the second area and is connected to the first surface and the third surface. Between the second areas, the third surface is inclined inwardly from the third area, and is connected between the first surface and the third area, and the micropores are opened in the first area. On the surface, or, the micropores are opened on the first surface and the second surface and/or the third surface.

In one of the embodiments, the pores on the first surface have a pore diameter in the range of 5-200 μm, the pores on the second surface have a pore diameter in the range of 10-200 μm, and the micropores on the third surface have a pore diameter in the range of 5-200 μm. The pore size range is 10-200μm.

In one embodiment, the drug-releasing balloon catheter further includes a first catheter and a second catheter. The second catheter is sheathed outside the first catheter, and the distal end of the first catheter is connected to the The first balloon is connected, the distal end of the second catheter is connected with the second balloon, the inner space of the first catheter forms a first channel, and the gap between the first catheter and the second catheter The space constitutes the second channel.

In one of the embodiments, the drug-releasing balloon catheter further includes a guide wire cavity, and both ends of the guide wire cavity are in communication with the outside.

In one of the embodiments, the drug-releasing balloon catheter further includes a visualization ring, and the visualization ring is located in the first chamber.

A drug release method, which is applied to a drug release balloon catheter. The drug release balloon catheter includes a first balloon, a second balloon, a first channel, and a second channel. The second balloon The balloon is set outside the first balloon, the inner space of the first balloon constitutes a first chamber, the space between the first balloon and the second balloon constitutes a second chamber, the The second balloon includes a first area, a second area disposed at the proximal end of the first area, and a third area disposed at the distal end of the first area respectively, and at least one micropore is opened in the first area , The drug release method includes:

Step 1. Deliver the drug-releasing balloon catheter to the diseased part of the cavity;

Step 2: Deliver pressurized fluid into the first chamber through the first passage, so that the first balloon expands to expand and support the chamber;

Step 3. The liquid medicine is delivered into the second chamber through the second channel, so that the second balloon is inflated. When the second balloon is in an inflated state, the diameter of the first region is smaller than the diameter of the second balloon. The diameter of the second area is smaller than the diameter of the third area, the second area and the third area are both attached to the inner wall of the cavity, and the first area is connected to the inner wall of the cavity Enclosed to form a drug release space M, the drug solution flows into the drug release space M through the micropores, and is used to treat the diseased part;

Step 4. After the treatment, the pressurized fluid in the first chamber is drawn out through the first channel, and the drug release balloon catheter is taken out.

In one of the embodiments, the drug-releasing balloon catheter further includes a guide wire lumen with both ends connected to the outside world. Before step 1, the guide wire is first inserted from the distal end of the guide wire lumen, and then From the proximal end of the guide wire lumen, the drug-releasing balloon catheter is moved along the guide wire.

In one of the embodiments, the drug-releasing balloon catheter further includes a developing ring located in the first chamber, and in step 1, the drug-releasing ball is observed through the developing ring Whether the balloon catheter is in place.

In one of the embodiments, after step 2 is completed, before step 3 is performed, part of the pressurized fluid in the first chamber is withdrawn through the first passage.

In one of the embodiments, the number of administrations is two or more times, the completion of step 3 once is the completion of one administration, and the recovery work step is performed between two adjacent administrations.

In one of the embodiments, the restoration work step includes:

Firstly withdraw the liquid medicine remaining in the medicine release space through the second channel;

Then withdraw part of the pressurized fluid in the first chamber through the first passage to reduce the pressure in the first balloon;

Finally, withdraw the liquid medicine remaining in the second chamber through the second channel, so that the second area and the third area are separated from the inner wall of the cavity, so that the cavity is restored Work.

In one of the embodiments, the time for a single administration is 3 minutes, and the working time after the cavity returns to work is 3 to 5 minutes.

In one of the embodiments, after the restoration work step is completed, and before step 3 is performed again, another step is required: replenishing the pressurized fluid to the first chamber through the first passage, so that The first balloon supports the cavity.

In one of the embodiments, in the step 4, after the treatment is completed, the drug release space and the remaining drug solution in the second chamber must be drawn out through the second channel before being taken out. The drug-releasing balloon catheter.

In one of the embodiments, after the treatment is over, the step of pumping out the pressurized fluid and the remaining liquid medicine is:

Then withdraw the liquid medicine remaining in the second chamber through the second channel;

Finally, the pressurized fluid remaining in the first chamber is drawn out through the first passage.

In one of the embodiments, the drug-releasing balloon catheter further includes a protective sleeve. Before step 1, the following steps are performed: the protective sleeve is placed on the second balloon, and the protective sleeve is passed through the second channel. After the physiological saline is input into the second chamber, the air in the second chamber is removed through the micropores, and then the protective cover is removed.

Compared with the prior art, the present invention has the following beneficial effects:

When the second balloon is in an inflated state, the diameter of the first area is smaller than the diameter of the second area, and the diameter of the first area is smaller than the diameter of the third area, and the second area and the third area are both attached to the inner wall of the cavity , The first area is enclosed with the inner wall of the cavity to form a drug release space. Under the barrier effect of the second and third regions, the liquid medicine in the drug release space will not be lost or is very little lost. At the same time, the fluid outside the drug release space cannot enter the drug release space. Therefore, the drug release space The medicinal solution can be fully used to treat diseased parts, increase the reprint rate, and achieve precise drug delivery. In addition, it also reduces the risk of clogging of the cavity caused by the loss of liquid medicine and the body's metabolic burden.

Description of the drawings

Fig. 1 is a schematic structural diagram of a drug-releasing balloon catheter provided in Example 1 of the present invention.

Fig. 2 is a schematic diagram of the partial coordination between the drug-releasing balloon catheter and the lumen shown in Fig. 1.

Fig. 3 is a top view of an adapter provided in Embodiment 1 of the present invention.

Fig. 4 is a schematic structural diagram of another drug-releasing balloon catheter provided in Example 2 of the present invention.

Reference signs: first balloon 11; second balloon 12; first chamber 13; second chamber 14; micropore 15; first surface 16; second surface 17; third surface 18; first catheter 21; second conduit 22; first channel 23; second channel 24; third conduit 25; developing ring 26; main body 31; first connecting tube 32; second connecting tube 33; third connecting tube 34; push tube 35; first communication port 41; second communication port 42; first area D1; second area D2; third area D3; drug release space M; working section N.

Detailed ways

The technical solution of the present invention will be further explained by specific embodiments below. It should be understood by those skilled in the art that the described embodiments are only to help understand the present invention and should not be regarded as specific limitations to the present invention.

Example 1

As shown in FIGS. 1 and 2, this embodiment provides a drug-releasing balloon catheter, which includes a first balloon 11, a second balloon 12, and a first channel 23 and a second channel 24 that are isolated from each other. The second balloon 12 is sleeved outside the first balloon 11, the inner space of the first balloon 11 constitutes the first chamber 13, and the space between the first balloon 11 and the second balloon 12 constitutes the second chamber 14. The first passage 23 is in communication with the first chamber 13, and the second passage 24 is in communication with the second chamber 14. The pressurized fluid can be delivered to the first chamber 13 through the first passage 23 or drawn from the first chamber 13. The liquid medicine can be transported to the second chamber 14 through the second channel 24 or can be drawn out from the second chamber 14. The second balloon 12 includes a first area D1, a second area D2 disposed at the proximal end of the first area D1, and a third area D3 disposed at the distal end of the first area D1. The first area D1 is provided with at least one micro孔15.

Before use, both the first balloon 11 and the second balloon 12 are in a folded state, so that the drug-releasing balloon catheter can be smoothly delivered to the diseased part of the lumen.

When in use, the pressurized fluid is delivered into the first chamber 13 through the first channel 23, so that the first balloon 11 is expanded to expand and support the cavity. The liquid medicine is delivered into the second chamber 14 through the second channel 24, so that the second balloon 12 is expanded. When the second balloon 12 is in an expanded state, the diameter of the first area D1 is smaller than the diameter of the second area D2, and The diameter of the first area D1 is smaller than the diameter of the third area D3, the second area D2 and the third area D3 are both attached to the inner wall of the cavity, and the first area D1 and the inner wall of the cavity form a drug release space M. The expansion of the second balloon 12 also makes the micropores 15 open, and the liquid medicine enters the drug release space M through the second channel 24, the second chamber 14, and the micropores 15 in sequence. Since the second area D2 and the third area D3 are attached to the inner wall of the cavity, the second area D2 and the third area D3 play a blocking role. Under the blocking action of the second area D2 and the third area D3, the liquid medicine in the drug release space M will not be lost or very little is lost. At the same time, the fluid outside the drug release space M cannot enter the drug release space M. Therefore, , The liquid medicine in the drug release space M can be fully used to treat the diseased part (shown in the shaded part in Fig. 2), which increases the reload rate and realizes precise drug delivery. In addition, it also reduces the risk of clogging of the cavity caused by the loss of liquid medicine and the body's metabolic burden.

After use, the drug release space M and the remaining liquid medicine in the second chamber 14 are drawn out through the second channel 24, and the pressurized fluid in the first chamber 13 is drawn out through the first channel 23, and finally, the release is taken out. Medicine balloon catheter.

In this embodiment, because the first balloon 11 needs to expand and support the lumen, the first balloon 11 is a semi-compliant balloon or a non-compliant balloon, and it is difficult for the compliant balloon to expand and support the cavity. The second balloon 12 can be a compliant balloon or a semi-compliant balloon or a non-compliant balloon. The second balloon 12 can be made of medical polymer materials, for example, silicon rubber, block copolymers of polyether and polyamide, polyethylene or polycarbonate, and the like.

Considering the stenosis of the pathological part of the cavity, it is necessary to open and support the cavity to treat the pathological part. In this embodiment, the first balloon 11 instead of the second balloon 12 is used to expand and support the cavity. This is because in order to open and support the cavity, the pressurized fluid needs to be delivered under high pressure. Especially when the inner wall of the cavity is calcified, if there is not enough pressure, it will be difficult to open and support the cavity. The second balloon 12 is provided with a micro-hole 15. If the liquid medicine is delivered to the second chamber 14 under high pressure, the micro-hole 15 will be over-expanded under the action of high pressure, and a large amount of liquid medicine will flow into the drug-releasing space. In M, it impacts the diseased part and causes discomfort to the body. Further, a large amount of liquid medicine will squeeze the second area D2 and the third area D3, and then rush into other parts of the cavity, thereby blocking the cavity and/or increasing the body Metabolic burden. Please refer to FIG. 1 again. When the first balloon 11 is in an inflated state, the middle part of the first balloon 11 is the working section N. The working section N is used to expand and support the cavity. Therefore, the shape of the working section N needs to match the formation of the cavity. For example, when the lumen is a blood vessel, the working segment N is cylindrical. The outer diameter of the working section N needs to be determined according to the inner diameter of the cavity, and the length of the working section N needs to be determined according to the length of the lesion. In one of the embodiments, when the lumen is a blood vessel, the outer diameter of the working section N is 1-30 mm, and the length of the working section N is 5-300 mm.

In this embodiment, when the second balloon 12 is in an inflated state, it is sufficient to make the diameter of the first area D1 smaller than the diameter of the second area D2, and the diameter of the first area D1 is smaller than the diameter of the third area D3, As for the size relationship between the diameter of the second area D2 and the diameter of the third area D3, it can be adjusted according to actual requirements. In one of the embodiments, the diameter of the first region D1 is 0.1%-50% smaller than the diameter of the second region D2, and/or the diameter of the first region D1 is 0.1%-50% smaller than the diameter of the third region D3.

In this embodiment, the first area D1 is composed of a first surface 16, a second surface 17 and a third surface 18. The second surface 17 is inclined inward from the second area D2, and is connected between the first surface 16 and the second area D2. The third surface 18 is inclined inward from the third area D3, and is connected between the first surface 16 and the third area D3. The first surface 16, the second surface 17, and the third surface 18 may all be flat or curved, and all may be smooth or rough surfaces, which are not limited here.

In this embodiment, the porosity of the micropores 15 in the first region D1 is 2%-80%. The micro holes 15 can be made by laser drilling or etching. The micropores 15 may be uniformly or unevenly distributed on the first region D1. Further, the micropores 15 may be provided on the first surface 16 only, or the micropores 15 may be provided on the first surface 16 and the second surface 17 and/or the third surface 18. The pore size of the micropores 15 depends on factors such as the concentration and viscosity of the liquid medicine. In one of the embodiments, the pore size of the micropores 15 on the first surface 16 is in the range of 5-200 μm, the pore diameter of the micropores 15 on the second surface 17 is in the range of 10-200 μm, and the micropores 15 on the third surface 18 are in the range of 10-200 μm. The pore size range is 10-200μm. The second surface 17 and the third surface 18 are both inclined surfaces, and the apertures of the micropores 15 on the second surface 17 and the third surface 18 are designed to be slightly larger, which facilitates the withdrawal of the liquid medicine.

In this embodiment, the pressurized fluid can be normal saline or normal saline mixed with a certain amount of heparin, as long as it can enter the first balloon 11 through the first passage 23 under pressure, so that the first balloon 11 is expanded. In turn, the first balloon 11 is expanded and supports the cavity.

In this embodiment, the medicinal liquid includes any one or a combination of at least two of the anti-inflammatory medicinal liquid, the anti-infective medicinal liquid, the scar-inhibiting medicinal liquid, and the anti-adhesion and anti-scarring medicinal liquid.

In this embodiment, the drug in the medicinal solution is selected from aspirin, salicylic acid, sodium salicylate, magnesium salicylate, diflunisal, di-salicylate, ibuprofen, indomethacin, fluorine Bibuprofen, Phenoxyibuprofen, Naproxen, Piroxicam, Butazepine, Fenprofen, Fenbufen, Carprofen, Ketoprofen, Diclofenac, Ketorolac, Tetraflufena Acid, sulindac, tolmetin, celecoxib, streptomycin, gentamicin, kanamycin, sisomicin, tobramycin, amikacin, netilmicin, lin Bizhi, isepamicin, penicillin, paromycin, paromomycin, neomycin, astromycin, glucocorticoid, triamcinolone acetonide, dexamethasone, betamethasone, cortisone , Hydrocortisone, mometasone furoate, rimexolone, prednisone, prednisolone, methylprednisolone, triamcinolone, budesonide, beclomethasone dipropionate, fluticasone propionate, cicles Naide, fluocinolone, clofloxasone, halometasone, difluxazone, halometasone, flucloxonide and its derivatives, erythromycin and its derivatives, azithromycin, middimecin and its derivatives Substances, spiramycin and its derivatives, acetylspiramycin, tacrolimus, sirolimus, everolimus, amphotericin B, pentamycin, fidaxomycin, telithromycin, silk Bisomycin, rapamycin, mometasone furoate, mitomycin, dexamethasone, cyclosporine A, berberine, berberine hydrochloride, paclitaxel, docetaxel, vinorelbine, elemi Any one or a combination of at least two of ene or enalapril.

In this embodiment, the liquid medicine can be dispersed in the biodegradable polymer, so that when the liquid medicine enters the diseased part, it can be slowly released. The biodegradable polymer can be selected from polyhydroxyalkanoates, polyhydroxybutyrate compounds, poly(glycerol-sebacic acid), polypeptides, polylactic acid, polyglycolic acid, polylactic acid-glycolic acid copolymer, Any one or a combination of at least two of polydioxanone, polylactic acid-polyethylene oxide copolymer, or hyaluronic acid.

In this embodiment, the drug-releasing balloon catheter further includes a first catheter 21 and a second catheter 22. The second catheter 22 is sleeved outside the first catheter 21, the distal end of the first catheter 21 is connected to the first balloon 11, and the distal end of the second catheter 22 is connected to the second balloon 12. The inner space of the first duct 21 constitutes the first passage 23, and the space between the first duct 21 and the second duct 22 constitutes the second passage 24. It is understandable that the first channel 23 and the second channel 24 can also be arranged in other ways, as long as the first channel 23 and the second channel 24 are isolated from each other, and the first channel 23 communicates with the first chamber 13, and the second channel It suffices that 24 is in communication with the second chamber 14. For example, an adapter (as shown in FIG. 3, not labeled) may be provided, and the adapter is provided with a first communication port 41 and a second communication port 42. Both the first balloon 11 and the second balloon 12 are connected to the adapter, and the first chamber 13 is in communication with the first communication port 41, and the second chamber 14 is in communication with the second communication port 42. In this way, the first duct 21 and the second duct 22 can be arranged side by side and inserted into the first communication port 41 and the second communication port 42 respectively. The internal space of the first duct 21 constitutes the first channel 23, and the second duct 22 The internal space constitutes the second passage 24.

In this embodiment, the drug-releasing balloon catheter further includes a connecting device (not marked in the figure) for connecting external equipment. The connecting device includes a main body portion 31 and a first connecting pipe 32 and a second connecting pipe 33 provided on the main body portion 31. Both the proximal end of the first catheter 21 and the proximal end of the second catheter 22 extend into the main body portion 31. One end of the first connecting pipe 32 extends into the main body portion 31 and is connected to and communicated with the first pipe 21. The other end of the first connecting pipe 32 is exposed outside the main body portion 31 and communicates with the outside. One end of the second connecting pipe 33 extends into the main body portion 31 and is connected to and communicated with the second conduit 22, and the other end of the second connecting pipe 33 is exposed outside the main body portion 31 and communicates with the outside. In this way, the pressurized fluid can enter the first chamber 13 through the first connecting pipe 32 and the first passage 23, or the pressurized fluid in the first chamber 13 can be passed through the first passage 23 and the first connecting pipe 32. Pull out. The medicinal solution can enter the second chamber 14 through the second connecting tube 33 and the second channel 24, and further enter the drug release space M through the micropores 15, or the drug release space M and the remaining drug in the second chamber 14 The liquid can be drawn out through the second channel 24 and the second connecting pipe 33.

In this embodiment, the drug-releasing balloon catheter further includes a third catheter 25. The connecting device further includes a third connecting tube 34 provided on the main body portion 31. The third catheter 25 is inserted through the first balloon 11 and the first catheter 21, and the distal end of the third catheter 25 passes through the first balloon 11 and the second balloon 12 and is exposed to the outside to communicate with the outside world. The proximal end of the third tube 25 extends into the main body 31, one end of the third connecting tube 34 extends into the main body 31, and is connected to and communicated with the third tube 25, and the other end of the third connecting tube 34 is exposed outside the main body 31 , Connect with the outside world. The inner cavity of the third catheter 25 and the third connecting tube 34 constitutes a guide wire lumen (not shown in the figure) for passing the guide wire (not shown in the figure). Specifically, the guide wire is inserted from the distal end of the third catheter 25 and passed out from the end of the third connecting tube 34 exposed outside the main body portion 31. In this way, the drug-releasing balloon catheter can move along the guide wire and be delivered to The lesion of the cavity. Understandably, the arrangement of the third duct 25 makes the first chamber 13 become the space between the first balloon 11 and the third duct 25, and the first passage 23 becomes the space between the first duct 21 and the third duct 25 Between the space.

In this embodiment, the drug-releasing balloon catheter further includes a developing ring 26. The developing ring 26 is arranged on the third duct 25 and is located in the first chamber 13. Through the visualization ring 26, it can be observed whether the drug-releasing balloon catheter is placed in place. There may be one or more than one imaging ring 26. In this embodiment, there are two imaging rings 26, which are located at the proximal end and the distal end of the first balloon 11, respectively.

This embodiment also provides a drug release method for the above-mentioned drug release balloon catheter, which includes the following steps:

Step 2: Deliver pressurized fluid into the first chamber 13 through the first channel 23, so that the first balloon 11 is expanded to expand and support the cavity;

Step 3. The liquid medicine is delivered into the second chamber 14 through the second channel 24, so that the second balloon 12 is inflated. When the second balloon 12 is in an inflated state, the diameter of the first area D1 is smaller than that of the second area D2. The diameter of the first area D1 is smaller than the diameter of the third area D3. The second area D2 and the third area D3 are both attached to the inner wall of the cavity. The first area D1 and the inner wall of the cavity form a drug release space. M, the medicinal solution flows into the drug release space M through the microhole 15 for treating the diseased part;

Step 4. After the treatment, the pressurized fluid in the first chamber 13 is drawn out through the first channel 23, and the drug-releasing balloon catheter is taken out.

Based on the above-mentioned drug release method, during treatment, the drug solution enters the drug release space M through the micropores 15. Under the blocking action of the second area D2 and the third area D3, the drug solution in the drug release space M will not be lost or There is very little loss, and at the same time, the fluid outside the drug release space M cannot enter the drug release space M. Therefore, the drug liquid in the drug release space M can be fully used to treat the diseased part, which increases the reload rate and realizes Precise drug delivery. In addition, it also reduces the risk of clogging of the cavity caused by the loss of liquid medicine and the body's metabolic burden.

Step 1 is to deliver the drug-releasing balloon catheter to the diseased part of the lumen. In order to deliver the drug-releasing balloon catheter to the diseased part of the lumen smoothly and accurately, before proceeding to step 1, the guide wire is first removed from the guidewire cavity. The distal end of the tube is penetrated, and then penetrated from the proximal end of the guide wire lumen, so that the drug-releasing balloon catheter moves along the guide wire, so that step 1 can be performed, which is to deliver the drug-releasing balloon catheter to the pathological part of the lumen. Further, in step 1, the visualization ring 26 can be used to observe whether the drug-releasing balloon catheter is placed in place.

Understandably, after step 2 is performed, the first balloon 11 not only expands the cavity, but also expands the second balloon 12. The distance between the first balloon 11 and the second balloon 12 is small, which means that the second chamber 14 is relatively small, which is not conducive to the delivery of liquid medicine into the second chamber 14. Therefore, before performing step 3, it is necessary to perform a step: withdraw part of the pressurized fluid in the first chamber 13 through the first passage 23. In this way, the pressure in the first balloon 11 can be reduced, so that the space between the first balloon 11 and the second balloon 12 can be increased, that is, the space of the second chamber 14 can be increased.

Step 3 is a single administration step. Considering that under the blocking effect of the second area D2 and the third area D3, the cavity cannot work normally, for example, the fluid in the cavity cannot circulate normally. Therefore, the time of a single administration It cannot be too long. If sufficient dosing is not possible within the safe time, multiple doses are required. If multiple administrations are required, step 3 needs to be performed multiple times, and the recovery work step is performed between two adjacent steps 3. That is, after step 3 is completed, the recovery work step is performed, then step 3 is performed, and then step 3 is performed again. Carry out the recovery steps...and so on, until the target number of doses is completed, then go to step 4. For example, when the target number of doses is 2 times, step 3 is required, and then the recovery work step is performed, and then step 3 is performed again. In this way, step 4 can only be performed after the target number of doses is completed twice.

The steps of restoring work are: firstly withdraw the residual liquid medicine in the drug release space M through the second channel 24 (understandably, if there is no pressure effect, the micropore 15 is in a closed state, therefore, the residual liquid in the drug release space M is removed After the liquid medicine is withdrawn, under the drive of no pressure, the liquid medicine in the second chamber 14 will not pass through the micro-holes 15 and then enter the drug release space M), and then withdraw back to the first chamber 13 through the first channel 23 Part of the pressurized fluid inside the first balloon 11 reduces the pressure in the first balloon 11, and finally withdraws the residual liquid medicine in the second chamber 14 through the second channel 24, so that the second area D2, the third area D3 and the cavity The inner wall is separated, so that the cavity can be restored to work. For example, when the lumen is a blood vessel, restoring the lumen to work is to restore the bleeding function.

The remaining liquid medicine in the drug release space M is first withdrawn through the second channel 24 to prevent the second area D2 and the third area D3 from being separated from the inner wall of the cavity after the second balloon 12 is depressurized, and no longer acts as a barrier. Function, the residual liquid medicine in the drug release space M flows into other areas of the cavity, and even flows into other parts of the body through the cavity, thereby causing blockage of the cavity and/or increasing the body's metabolic burden.

Part of the pressurized fluid is then withdrawn through the first passage 23 to reduce the pressure in the first balloon 11 in order to increase the space between the first balloon 11 and the second balloon 12, that is, to increase the second chamber 14 space. After the space of the second chamber 14 is increased, the residual liquid in the second chamber 14 can be easily drawn back. Otherwise, it is difficult to apply suction to the residual liquid in the second chamber 14, and it is difficult to suck cleanly. .

The time for a single administration and the working time after the cavity is restored to work need to be determined according to the type of cavity. For example, when the cavity is a blood vessel, the time for a single administration is 3 minutes, and the working time after the cavity is restored to work is 3 to 5 minutes.

Considering that part of the pressurized fluid in the first chamber 13 is withdrawn during the restoration work step, therefore, after the restoration work step is completed, before step 3 is performed again, another step is required: to pass through the first channel 23 to the first chamber 13 A cavity 13 is supplemented with pressurized fluid, so that the first balloon 11 can still support the cavity.

It is understandable that after the treatment, there may still be liquid medicine remaining in the drug release space M and the second chamber 14. Therefore, after the treatment, not only the pressurized fluid in the first chamber 13 must be pumped out through the first channel 23, but also the drug release space M and the residual liquid medicine in the second chamber 24 must be pumped out through the second channel 24. After that, the delivery balloon catheter can be removed. The specific steps are: firstly withdraw the residual liquid medicine in the drug release space M through the second channel 24, and then withdraw part of the pressurized fluid in the first chamber 13 through the first channel 23, so as to reduce the amount of the liquid in the first balloon 11. The pressure, then the residual liquid medicine in the second chamber 14 is drawn out through the second channel 24, and finally the pressurized fluid remaining in the first chamber 13 is drawn out through the first channel 23.

Proceed to the step of "first withdraw the residual liquid medicine in the drug release space M through the second passage 24", and proceed to the step of "then withdraw part of the pressurized fluid in the first chamber 13 through the first passage 23 to reduce the first The reason for the "pressure in the balloon 11" is the same as the reason in the recovery work step, and will not be repeated here.

In addition, it should be understood that the space between the first balloon 11 and the second balloon 12, that is, the second chamber 14, is filled with air before the liquid medicine is filled. When the liquid medicine is input into the second chamber 14 through the second channel 24, the air in the second chamber 14 will be discharged. Some cavities in the body are not suitable for intervention with air. For example, when the cavities are blood vessels, air entering the blood vessels may cause thrombosis. Therefore, it is necessary to remove the air in the second chamber 14 before proceeding to step 1. Specifically, before proceeding to step 1, the following steps are performed: a protective sleeve (not shown in the figure) is placed on the second balloon 12, and physiological saline is inputted into the second chamber 14 through the second channel 24, and passed through the microhole 15. After the air in the second chamber 14 is removed, the protective cover is removed. The second balloon 12 is sheathed with a protective cover to prevent the second balloon 12 from being inflated under the filling action of the physiological saline after the physiological saline is infused, so that the drug-releasing balloon catheter cannot enter the cavity.

This embodiment provides a drug-releasing balloon catheter and a drug-releasing method thereof, wherein the second balloon 12 of the drug-releasing balloon catheter includes a first area D1 and a second area respectively arranged at the proximal end of the first area D1 D2 and a third area D3 arranged at the distal end of the first area D1. The first area D1 is provided with at least one micro-hole 15. When the second balloon 12 is in an inflated state, the diameter of the first area D1 is smaller than that of the second area The diameter of D2, and the diameter of the first area D1 is smaller than the diameter of the third area D3, the second area D2 and the third area D3 are both attached to the inner wall of the cavity, and the first area D1 is enclosed with the inner wall of the cavity to form a relief Medicine Space M. Under the barrier effect of the second area D2 and the third area D3, the liquid medicine in the drug release space M will not be lost or very little lost. At the same time, the fluid outside the drug release space M cannot enter the drug release space M, so , The liquid medicine in the drug release space M can be fully used to treat the diseased part, which increases the reload rate and realizes precise drug delivery. In addition, it also reduces the risk of clogging of the cavity caused by the loss of liquid medicine and the body's metabolic burden.

Example 2

As shown in Figure 4, this embodiment provides another drug-releasing balloon catheter. Compared with the drug-releasing balloon catheter of Example 1, the differences are: 1) the connecting device is different; 2) the first catheter 11 The way of fitting is different from the connecting device; 3) The setting way of the third conduit 25 is different.

In this embodiment, the connecting device includes a main body portion 31, a first connecting tube 32 disposed on the main body portion 31, a second connecting tube 33 disposed on the main body portion 31, and a push tube 35, excluding the one described in Embodiment 1. The third connecting pipe 34.

In this embodiment, the proximal end of the first catheter 21 does not extend into the main body portion 31 but is arranged close to the main body portion 31. One end of the first connecting tube 32 extends into the main body portion 31 to connect to and communicate with the proximal end of the push tube 35, and the other end of the first connecting tube 32 is exposed outside the main body portion 31 and communicates with the outside. The distal end of the push tube 35 extends in the second tube 12 toward the first tube 11 to be inserted into the first tube 11 so as to communicate with the first tube 11. In this way, the pressurized fluid can enter the first chamber 13 through the first connecting pipe 32, the push pipe 35 and the first passage 23, or the pressurized fluid in the first chamber 13 can pass through the first passage 23, the push pipe 35 and the first connecting pipe 32 are drawn out.

Please refer to FIG. 4 again, the distal end of the push tube 35 is partially cut off along the axial direction of the push tube 35. In this way, the strength of the push tube 35 can be reduced to prevent the push tube 35 from being too strong and causing damage to the first catheter 11. The push tube 35 may be made of stainless steel.

In this embodiment, the proximal end of the third conduit 25 extends to the distal end of the push tube 35 and is bent, and after passing through the first conduit 21, it penetrates the second conduit 22 to communicate with the outside. The inner cavity of the third catheter 25 constitutes a guide wire lumen (not shown in the figure). The guide wire (not shown in the figure) penetrates from the distal end of the third catheter 25 and extends along the guide wire lumen, from the vicinity of the third catheter 25. End through out. Understandably, as long as both ends of the guidewire lumen are in communication with the outside, the guidewire can be inserted from the distal end of the guidewire lumen, and then pass through the proximal end of the guidewire lumen.

This embodiment also provides a drug release method, which is the same as the drug release method in Example 1, and will not be repeated here.

The applicant declares that the above are only specific implementations of the present invention, but the scope of protection of the present invention is not limited to this, and those skilled in the art should understand that anyone who belongs to the technical field disclosed in the present invention Any changes or substitutions that can be easily conceived within the technical scope fall within the scope of protection and disclosure of the present invention.

Claims

A drug-releasing balloon catheter, characterized in that the drug-releasing balloon catheter comprises a first balloon, a second balloon, and a first channel and a second channel that are isolated from each other, and the second balloon is sleeved on Outside the first balloon, the internal space of the first balloon constitutes a first chamber, the space between the first balloon and the second balloon constitutes a second chamber, and the first channel is connected to The first chamber is in communication, the second passage is in communication with the second chamber, and pressurized fluid is delivered to the first chamber through the first passage, or is delivered from the first chamber. Withdrawn, the medical solution is delivered to the second chamber through the second channel, or is drawn from the second chamber, the second balloon includes a first area and is respectively disposed in the first area The proximal second region and the third region arranged at the distal end of the first region are provided with at least one micropore. When the drug is released, the second balloon is in an inflated state. The diameter of the first area is smaller than the diameter of the second area and smaller than the diameter of the third area. Both the second area and the third area are attached to the inner wall of the cavity. The inner wall of the road is enclosed to form a drug release space.
The drug release balloon catheter according to claim 1, wherein when the second balloon is in an inflated state, the diameter of the first area is 0.1%-50% smaller than the diameter of the second area, And/or the diameter of the first area is 0.1%-50% smaller than the diameter of the third area.
The drug release balloon catheter according to claim 1, wherein in the first area, the porosity of the micropores is 2%-80%.
The drug release balloon catheter according to claim 1, wherein the first area is composed of a first surface, a second surface, and a third surface, and the second surface is inward from the second area Inclined and connected between the first surface and the second area, the third surface is inclined inward from the third area, and connected between the first surface and the third area, The micropores are opened on the first surface, or the micropores are opened on the first surface and the second surface and/or the third surface.
The drug-releasing balloon catheter according to claim 4, wherein the pore size of the micropores on the first surface is in the range of 5-200 μm, and the pore size of the micropores on the second surface is in the range of 10-200 μm. The pore size of the micropores on the third surface is in the range of 10-200 μm.
The drug release balloon catheter according to claim 1, wherein the pressurized fluid is delivered into the first chamber through the first channel, so that when the first balloon is inflated, the first A balloon expands and supports the cavity.
The drug-releasing balloon catheter according to claim 6, wherein when the first balloon is in an inflated state, the middle part of the first balloon is a working section for expanding and supporting the The cavity, the shape of the working section matches the shape of the cavity.
The drug release balloon catheter according to claim 7, wherein the working section is cylindrical, the outer diameter of the working section is 1-30 mm, and the length of the working section is 5-300 mm.
The drug-releasing balloon catheter according to claim 1, wherein the drug-releasing balloon catheter further comprises a guide wire cavity, and both ends of the guide wire cavity are in communication with the outside.
The drug-releasing balloon catheter of claim 1, wherein the drug-releasing balloon catheter further comprises a visualization ring, and the visualization ring is located in the first chamber.
A drug release method, characterized in that the drug release method is applied to a drug release balloon catheter, and the drug release balloon catheter includes a first balloon, a second balloon, a first channel, and a second channel. The second balloon is sleeved outside the first balloon, the inner space of the first balloon forms a first chamber, and the space between the first balloon and the second balloon forms a second chamber The second balloon includes a first area, a second area disposed at the proximal end of the first area, and a third area disposed at the distal end of the first area respectively, and the first area is provided with At least one micropore, and the drug release method includes:

Step 1. Deliver the drug-releasing balloon catheter to the diseased part of the cavity;

Step 2: Deliver pressurized fluid into the first chamber through the first passage, so that the first balloon expands to expand and support the chamber;

Step 3. The liquid medicine is delivered into the second chamber through the second channel, so that the second balloon is inflated. When the second balloon is in an inflated state, the diameter of the first region is smaller than the diameter of the second balloon. The diameter of the second area is smaller than the diameter of the third area, the second area and the third area are both attached to the inner wall of the cavity, and the first area is connected to the inner wall of the cavity. Enclosed to form a drug release space M, the drug solution flows into the drug release space M through the micropores, and is used to treat the diseased part;

Step 4. After the treatment, the pressurized fluid in the first chamber is drawn out through the first channel, and the drug release balloon catheter is taken out.
The drug release method according to claim 11, wherein the drug release balloon catheter further comprises a guide wire lumen with both ends connected to the outside world. Before step 1, the guide wire is removed from the guide wire. The distal end of the cavity penetrates, and then penetrates from the proximal end of the guide wire lumen, so that the drug-releasing balloon catheter moves along the guide wire.
The drug release method according to claim 11, wherein the drug release balloon catheter further comprises a development ring, and in step 1, the development ring is used to observe whether the drug release balloon catheter is placed In place.
The drug release method according to claim 11, wherein after step 2 is completed, before step 3 is performed, part of the pressurized fluid in the first chamber is withdrawn through the first channel.
The drug release method according to claim 11, wherein the number of administrations is two or more times, the completion of step 3 once is to complete one administration, and the recovery work step is performed between adjacent two administrations.
The drug release method according to claim 15, wherein the step of restoring work comprises:

Firstly withdraw the liquid medicine remaining in the medicine release space through the second channel;

Then withdraw part of the pressurized fluid in the first chamber through the first passage to reduce the pressure in the first balloon;

Finally, withdraw the liquid medicine remaining in the second chamber through the second channel, so that the second area and the third area are separated from the inner wall of the cavity, so that the cavity is restored Work.
The drug release method according to claim 16, characterized in that, after completing the restoring work step and before performing step 3 again, it is also necessary to perform a step: to pass through the first channel to the first chamber The pressurized fluid is supplemented so that the first balloon supports the cavity.
The drug release method according to claim 11, characterized in that, in the step 4, after the treatment is completed, the drug release space and the residual all in the second chamber are further removed through the second channel. The drug-releasing balloon catheter can be taken out only after the liquid medicine is drawn out.
The drug release method according to claim 18, wherein after the treatment, the step of extracting the pressurized fluid and the remaining liquid medicine is:

Firstly withdraw the liquid medicine remaining in the medicine release space through the second channel;

Then withdraw part of the pressurized fluid in the first chamber through the first passage to reduce the pressure in the first balloon;

Then withdraw the liquid medicine remaining in the second chamber through the second channel;

Finally, the pressurized fluid remaining in the first chamber is drawn out through the first passage.
The drug release method according to claim 11, wherein the drug release balloon catheter further comprises a protective cover, and before step 1, the first step is to cover the second balloon with the protective cover , Inputting physiological saline into the second chamber through the second channel, and removing the air in the second chamber through the micropores, and then removing the protective cover.