Drug injection balloon catheter system

Abstract

The invention discloses a medicine injection balloon catheter system which comprises a balloon catheter, a medicine container and a piston assembly, the medicine container is provided with a medicine outlet hole, a liquid inlet hole and a first air outlet hole, the medicine outlet hole is communicated with the multi-balloon catheter, and the piston assembly is arranged in the medicine container in a sliding mode and dynamically divides the interior of the medicine container into a first chamber and a second chamber. The piston assembly comprises a piston cylinder and a piston rod which are detachably matched, the piston cylinder is provided with a filter membrane capable of separating gas and liquid, and a second air outlet communicated with the first chamber is formed in the piston cylinder. The piston assembly has a combination state that the piston rod and the piston cylinder are fixed and a free state that the piston rod can slide in the piston cylinder, and in the free state, the piston rod slides to form an air passing channel used for exhausting air in the second chamber through the air passing channel and the first chamber. According to the medicine injection balloon catheter system, the medicine reagent can be conveniently prepared and used at present, bubbles in the medicine reagent can be eliminated, and the influence on the medicine injection effect is avoided.

Description

Technical Field

[0001] This application relates to the technical field of medical devices, and particularly to an infusion balloon catheter system. Background Art

[0002] Vascular diseases are close to the top of the list of human causes of death. For most vascular diseases, whether organic or functional, the basic pathological change is organ ischemic change caused by stenosis or occlusion of the blood vessel lumen. Currently, angioplasty and / or implantation of metal stents are mainly used to open the calcified lesions of blood vessels to achieve the purpose of revascularization. However, when the blood vessel is dilated, it will cause damage to the blood vessel wall, thereby triggering the formation of thrombus and the release of growth factors, which will lead to the occurrence of restenosis or the re-occlusion of the dilated blood vessel later.

[0003] To counter restenosis, drugs for treatment are applied to the blood vessel during dilation, such as cell growth inhibitory drugs and anti-proliferative drugs, etc. Currently, the infusion balloon catheter system is a commonly used interventional device for applying drugs to the blood vessel. The principle of drug use is usually to prepare the drug reagent immediately before use. Therefore, it is necessary to pre-prepare the drug reagent before operation, and then perfuse the drug reagent into the balloon catheter, and deliver the drug to the designated position of the blood vessel through the balloon catheter, which is cumbersome in operation. Or the infusion balloon catheter system is provided with a drug container that can hold the drug. During operation, it is necessary to inject a dispersant into the drug container to mix with the drug to form a drug reagent, and then perfuse the drug reagent into the balloon catheter. However, bubbles are easily generated when the dispersant and the drug are mixed in the drug container and / or when the drug reagent is transported through the catheter, which affects the infusion effect. Summary of the Invention

[0004] In view of the problems in the prior art, this application provides an infusion balloon catheter system, which is convenient for preparing and using the drug reagent immediately, and can eliminate the bubbles in the drug reagent to avoid affecting the infusion effect.

[0005] The infusion balloon catheter system provided by this application includes:

[0006] A balloon catheter having a proximal end and a distal end;

[0007] A drug container communicating with the proximal end of the balloon catheter. The drug container is provided with a drug outlet hole, a liquid inlet hole, and a first air outlet hole, and the drug outlet hole communicates with the balloon catheter;

[0008] The piston assembly is slidably disposed inside the medicine container and dynamically divides the inside of the medicine container into a first chamber and a second chamber. The first air outlet communicates with the first chamber, and the medicine outlet hole and the liquid inlet hole both communicate with the second chamber. The piston assembly includes a piston cylinder and a piston rod that are detachably fitted. The piston cylinder is provided with a second air outlet communicating with the first chamber. The piston assembly has a combined state in which the piston rod is fixed to the piston cylinder and a free state in which the piston rod can slide within the piston cylinder. In the free state, the piston rod slides to form an air passage, and the piston cylinder is provided with a filter membrane capable of separating gas and liquid for discharging the gas in the second chamber through the air passage and the first chamber.

[0009] The following also provides several optional ways, which are not additional limitations to the above overall solution, but only further supplements or preferences. On the premise of no technical or logical contradictions, each optional way can be combined with the above overall solution separately, or multiple optional ways can be combined with each other.

[0010] Optionally, the piston cylinder includes a cylinder and a first piston fixed to one end of the cylinder. The second air outlet is provided on the side wall of the cylinder. The first piston is provided with an axial through hole, and the filter membrane is fixed in the through hole.

[0011] The piston rod includes a rod body, a second piston, and a positioning column connected in sequence. The positioning column is detachably fitted with the through hole.

[0012] Optionally, the positioning column and the through hole are in threaded fit.

[0013] Optionally, the side wall at the top end of the through hole is provided with a threaded structure, and the filter membrane is fixed at the distal end of the through hole.

[0014] Optionally, the outer wall of the cylinder is provided with an elastic buckle, and a clamping groove cooperating with the elastic buckle is provided in the medicine container.

[0015] Optionally, the aperture of the first air outlet is 5 - 10 mm.

[0016] Optionally, there are multiple second air outlets, and the aperture is 0.5 - 1.5 mm.

[0017] Optionally, the aperture of the through hole is 3 - 12 mm.

[0018] Optionally, the filter membrane is an ePTFE microporous membrane.

[0019] Optionally, the medicine container is a cylinder open at the top, including a bottom wall and a side wall. An outlet hole is provided on the bottom wall, an inlet hole is provided on the side wall of the second chamber, and a first air outlet hole is provided on the side wall of the first chamber. Optionally, the medicine container includes a cylinder open at both ends and an end cap detachably installed at one end of the cylinder. The piston assembly is slidably disposed inside the cylinder, and a medicine outlet hole is provided on the end cap.

[0020] Optionally, the balloon catheter includes a balloon body and a catheter assembly. The medicine container is communicated with the proximal end of the catheter assembly, and the wall of the balloon body has a pore structure.

[0021] The present application also provides an injection balloon catheter system, including:

[0022] A balloon catheter having a proximal end and a distal end;

[0023] A medicine container communicated with the proximal end of the balloon catheter. The medicine container is provided with a medicine outlet hole, an inlet hole, and a first air outlet hole. The medicine outlet hole is communicated with the balloon catheter;

[0024] A piston assembly slidably disposed inside the medicine container and dynamically separating the inside of the medicine container into a first chamber and a second chamber. The first air outlet hole is communicated with the first chamber, and both the medicine outlet hole and the inlet hole are communicated with the second chamber. The piston assembly includes a piston cylinder and a piston rod that are detachably engaged. A second air outlet hole communicated with the first chamber is provided on the piston cylinder. The piston assembly has a combined state in which the piston rod is fixed to the piston cylinder and a free state in which the piston rod can slide inside the piston cylinder. In the free state, the piston rod slides to form an air passage, and the piston cylinder is provided with a filter membrane that can separate gas and liquid, for discharging the gas in the second chamber through the air passage and the first chamber;

[0025] A medicine, contained in the medicine container.

[0026] Compared with the prior art, the present application provides an injection balloon catheter system that facilitates the immediate preparation and use of a medicine reagent. The piston assembly can eliminate the gas in the medicine reagent and avoid generating air bubbles, which affects the injection effect. BRIEF DESCRIPTION OF THE DRAWINGS

[0027] Figure 1 is a schematic structural diagram of an injection balloon catheter system in an embodiment of the present application;

[0028] Figure 2 is a schematic structural diagram of the injection balloon catheter system in another state;

[0029] Figure 3 is a schematic diagram of the pore structure on the balloon body in an embodiment;

[0030] Figure 4 Schematic structural diagram of a traditional Chinese medicine container in an embodiment;

[0031] Figure 5 Combined schematic diagram of a traditional Chinese medicine container and a piston assembly in an embodiment;

[0032] Figure 6 is Figure 5 exploded view of;

[0033] Figure 7 is Figure 6 further exploded view of;

[0034] Figure 8 Cross-sectional view of the medicine container and the piston assembly in the combined state;

[0035] Figure 9 Cross-sectional view of the medicine container and the piston assembly in the free state;

[0036] Figure 10 Schematic structural diagram of an injection balloon catheter in another embodiment;

[0037] Figure 11 Schematic structural diagram of the injection balloon catheter system in another state.

[0038] Explanation of the reference numerals in the figure is as follows:

[0039] 110, balloon body; 111, inner cavity; 112, pore structure;

[0040] 120, catheter assembly; 121, catheter; 1211, exchange hole; 122, stress relief tube;

[0041] 130, medicine container; 131, first chamber; 132, second chamber; 133, medicine outlet hole; 134, liquid inlet hole; 135, first air outlet hole; 136, cylinder body; 137, end cap; 138, clamping groove;

[0042] 140, piston assembly; 141, piston cylinder; 1411, cylinder; 1412, second air outlet hole; 1413, elastic buckle; 1414, air passage; 1415, first piston; 1416, through hole; 142, piston rod; 1421, rod body; 1422, second piston; 1423, positioning column; 143, filter membrane;

[0043] 150, filling device; 151, filling chamber; 152, piston; 153, piston handle;

[0044] 160, one-way valve;

[0045] 170, three-way valve;

[0046] 180, guide wire. Detailed implementation mode

[0047] The following will clearly and completely describe the technical solutions in the embodiments of the present application with reference to the accompanying drawings in the embodiments of the present application. Obviously, the described embodiments are only a part of the embodiments of the present application, rather than all the embodiments. Based on the embodiments in the present application, all other embodiments obtained by those of ordinary skill in the art without creative efforts shall fall within the protection scope of the present application.

[0048] It should be noted that when a component is referred to as being "connected" to another component, it can be directly connected to the other component or there may also be an intermediate component. When a component is considered to be "disposed on" another component, it can be directly disposed on the other component or there may be an intermediate component at the same time.

[0049] Unless otherwise defined, all technical and scientific terms used herein have the same meaning as commonly understood by those of ordinary skill in the technical field to which this application belongs. The terms used herein in the specification of this application are only for the purpose of describing specific embodiments and are not intended to limit this application. The term "and / or" used herein includes any and all combinations of one or more of the related listed items.

[0050] Refer to Figures 1 to 11 , an embodiment of the present application provides a drug injection balloon catheter system, including a balloon catheter, a drug container 130, and a piston assembly 140. The balloon catheter has opposite proximal and distal ends for delivering and releasing drugs. The drug container 130 is connected to the proximal end of the balloon catheter. The drug container 130 is provided with a drug outlet hole 133, a liquid inlet hole 134, and a first air outlet hole 135. The drug outlet hole 133 is connected to the balloon catheter. The piston assembly 140 is slidably disposed inside the drug container 130 and dynamically divides the inside of the drug container 130 into a first chamber 131 and a second chamber 132. The first air outlet hole 135 communicates with the first chamber 131. Both the liquid inlet hole 134 and the drug outlet hole 133 communicate with the second chamber 132. The piston assembly 140 includes a detachable piston cylinder 141 and a piston rod 142. The piston cylinder 141 is provided with a second air outlet hole 1412 communicating with the first chamber 131. The piston assembly has a combined state in which the piston rod 142 is fixed to the piston cylinder 141 and a free state in which the piston rod 142 can slide inside the piston cylinder 141. In the free state, the piston rod 142 slides to form an air passage 1414. The piston cylinder 141 is also provided with a filter membrane 143 that can separate gas and liquid for discharging the gas in the second chamber through the air passage 1414 and the first chamber 131. In this embodiment, the drug container 130 is used to contain drugs. Solvent can be injected into the drug container 130 through the liquid inlet hole 134 to prepare a drug reagent. Before drug injection, the piston assembly 140 can extrude the gas in the drug reagent to avoid the generation of bubbles.

[0051] See Figure 3 Figure 3 , the balloon catheter generally includes a balloon body 110 and a catheter assembly 120. The balloon body 110 is located at the distal end of the catheter assembly 120. The balloon body 110 has a lumen 111, and its balloon wall is provided with a pore structure 112. The catheter assembly 120 is connected to the balloon body 110 and extends proximally. The drug outlet hole 133 communicates with the catheter assembly 120.

[0052] The pore size of the pore structure 112 is 3 - 16 μm, and the porosity is 30 - 80%. The pore size of the first air outlet 135 is 5 - 10 mm, such as 6 - 8 mm, and for another example, 7.8 mm. The pore size of the drug outlet hole 133 is 5 - 10 mm, such as 6 - 8 mm, and for another example, 7.8 mm.

[0053] In one embodiment, a plurality of second air outlet holes 1412 are provided, and their pore size is 0.5 - 1.5 mm, such as 0.8 - 1.0 mm. Along the circumferential direction of the cylinder, the second air outlet holes 1412 are divided into multiple groups. For example, they are symmetrically distributed in 2 groups, and the number of the second air outlet holes 1412 in each group can be 3.

[0054] See Figures 4 to 6 In the shown embodiment, the drug container 130 is a cylindrical structure with an open top, including a bottom wall and a side wall. The bottom wall is provided with a liquid outlet hole, and the side wall of the first chamber 131 is provided with a first air outlet 135.

[0055] Loading the drug can be carried out in the production process of the drug - injection balloon catheter system. As a whole product, that is, the drug - injection balloon catheter system includes a balloon body 110, a catheter assembly 120, a drug container 130, and a piston assembly 140. The drug container 130 contains the drug. For example, the drug is contained in the second chamber 132. It can also be carried out in the use process of the drug - injection balloon catheter system. According to actual application needs, the action of loading the drug can be performed separately, which is flexible and controllable.

[0056] The drug reagent is a cell growth - inhibitory drug and / or an anti - proliferative drug. For example, it is at least one of rapamycin, sirolimus, everolimus, zotarolimus, 42 - (dimethylphosphinyl) rapamycin (deforolimus), deforomimus, biolimus, umirolimus, tacrolimus, paclitaxel, protaxel, docetaxel.

[0057] See Figure 7, for the convenience of the medicine container 130 to hold medicine, in one embodiment, the medicine container 130 includes a detachably fitted cylinder body 136 and an end cap 137. The two ends of the cylinder body 136 are open, the end cap 137 is detachably installed at one end of the cylinder body 136, the piston assembly 140 is slidably disposed inside the cylinder body 136, and a medicine outlet hole 133 is formed in the end cap 137. Specifically, the end cap 137 and the cylinder body 136 are connected by a threaded structure, and in the connected state, the end cap 137 and the inner wall of the cylinder body 136 have a smooth transition to avoid interfering with the sliding of the piston assembly 140.

[0058] The piston cylinder 141 includes a cylinder 1411 and a first piston 1415 fixed to one end of the cylinder. A second air outlet hole 1412 is formed in the side wall of the cylinder 1411. The first piston 1415 has an axial through hole 1416, and a gas-liquid separating filter membrane 143 is fixed in the through hole 1416. The piston rod 142 includes a rod body 1421 and a second piston 1422 fixed to the rod body 1421. A positioning post 1423 is provided at one end of the second piston 1422. The through hole 1416 and the positioning post 1423 can be threadedly engaged. For example, the inner wall of the proximal end of the through hole 1416 has a threaded structure, and the filter membrane 143 is fixed to the distal end of the through hole 1416. In the assembled state, the piston rod 142 blocks the through hole 1416; in the disassembled state, the piston rod slides in the piston cylinder to release a space, which is a gas passage 1414. The gas in the second chamber 132 is discharged to the first chamber 131 through the gas passage 1414 and the second air outlet hole 1412, and then discharged through the first air outlet hole 135.

[0059] Among them, the diameter of the through hole 1416 is 3 - 12 mm, for example, 4 - 9 mm, and for another example, 5 - 7 mm. The gas-liquid separating filter membrane 143 of the present application is a waterproof and breathable filter membrane, such as an ePTFE microporous membrane.

[0060] For the convenience of fixing the piston rod 142 to the piston cylinder 141, an elastic buckle 1413 is provided on the outer wall of the cylinder 1411. Correspondingly, a card slot 138 is provided inside the medicine container 130. Through the cooperation of the elastic buckle 1413 and the card slot 138, the piston cylinder 141 can be supported in the medicine container, which is convenient for the piston rod 142 and the piston cylinder 141 to be threadedly engaged to realize their fixed connection. Among them, the elastic buckle 1413 can be semi-circular, and a plurality of elastic buckles 1413 are provided along the circumferential direction of the cylinder 1411, for example, 2. In one embodiment, a gas-liquid separating filter membrane 143 is provided in the medicine outlet hole 133. The filter membrane 143 can perform a second exhaust on the medicine reagent during medicine outlet to avoid generating bubbles and ensure the medicine injection effect. To prevent the liquid in the second chamber 132 from flowing back through the liquid inlet hole 134, a one-way valve is also provided at the position of the liquid inlet hole 134.

[0061] From the perspective of drug preservation, the drug container 130 can be made of a light-shielding material, such as brown translucent glass. In addition, the drug container 130 is packaged in a vacuum-sealed manner.

[0062] In one embodiment, the side wall of the drug container 130 is provided with visible scales, which is convenient for observation and is beneficial to controlling the preparation of the drug solution and the dosage of the drug output.

[0063] See Figure 1 、 2 , in one embodiment, a one-way valve 160 is provided between the drug container 130 and the catheter assembly 120. When the push rod is driven to slide to inject liquid into the drug container 130 (the arrows respectively represent the movement direction of the push rod and the liquid injection direction), the one-way valve 160 is in a shut-off state. When the piston assembly 140 is driven to slide to make the drug reagent flow towards the catheter assembly 120 (the arrow represents the movement direction of the push rod), the one-way valve 160 is opened under pressure and is in an open state allowing the drug reagent to pass through.

[0064] In one embodiment, the catheter assembly 120 includes a catheter 121. The distal end of the catheter 121 is connected to the balloon body 110 and is internally connected. The inside of the catheter 121 provides a guide wire channel and a fluid channel. For the convenience of the guide wire to penetrate, an exchange hole 1211 allowing the guide wire to penetrate is provided on the catheter wall. The catheter assembly 120 further includes a stress relief tube 122, and the stress relief tube 122 is connected to the proximal end of the catheter 121.

[0065] In another embodiment, the catheter assembly 120 includes a catheter 121, a stress relief tube 122, and a catheter seat connected in sequence from the distal end to the proximal end. The catheter 121 includes an inner tube and an outer tube. The inner tube provides a guide wire channel, and the radial gap between the inner tube and the outer tube provides a fluid channel. The catheter seat is provided with a drug injection port communicating with the drug container 130 and a guide wire port for the guide wire to penetrate.

[0066] See Figure 10 、 11 In the embodiment shown in

[0067] When using the drug injection balloon catheter system, a solvent and a drug can be filled into the drug container 130 through the liquid inlet hole 134 to be formulated into a drug reagent. Then, the piston assembly 140 is driven to slide to compress the second chamber 132. During the compression process, the filter membrane 143 separates gas from liquid, expelling the gas in the drug reagent. These gases are discharged through the first air outlet hole 135 of the first chamber 131. After the gas-liquid separation is completed, drug delivery is carried out to deliver the drug to the inner cavity 111.

[0068] The drug injection balloon catheter system of the present application facilitates the immediate preparation and use of the drug reagent, and can eliminate the air bubbles in the drug reagent to avoid affecting the drug injection effect.

[0069] The technical features of the above-described embodiments can be combined arbitrarily. For the sake of brevity of description, not all possible combinations of the technical features in the above-described embodiments are described. However, as long as there is no contradiction in the combination of these technical features, it should be considered as the scope described in this specification. When the technical features in different embodiments are shown in the same drawing, it can be regarded that the drawing also discloses the combination examples of the various embodiments involved at the same time.

[0070] The above-described embodiments only represent several implementation manners of the present application. The description is relatively specific and detailed, but it should not be construed as a limitation on the patent scope of the present application. It should be noted that for those of ordinary skill in the art, without departing from the concept of the present application, several modifications and improvements can still be made, and these all belong to the protection scope of the present application. Therefore, the protection scope of the present application should be subject to the appended claims.

Claims

1. Infusion balloon catheter system, characterized in that, comprising: a balloon catheter having a proximal end and a distal end; a medicine container connected to the proximal end of the balloon catheter, the medicine container being provided with a medicine outlet hole, a liquid inlet hole and a first air outlet hole, the medicine outlet hole being communicated with the balloon catheter; a piston assembly slidably disposed inside the medicine container and dynamically separating the inside of the medicine container into a first chamber and a second chamber, the first air outlet hole communicating with the first chamber, the medicine outlet hole and the liquid inlet hole both communicating with the second chamber, the piston assembly including a piston cylinder and a piston rod that are detachably fitted, the piston cylinder being provided with a second air outlet hole communicating with the first chamber, the piston assembly having a combined state in which the piston rod is fixed to the piston cylinder and a free state in which the piston rod can slide inside the piston cylinder, in the free state, the piston rod slides to form an air passage, and the piston cylinder is provided with a filter membrane that can separate gas and liquid for discharging the gas in the second chamber through the air passage and the first chamber.

2. The infusion balloon catheter system according to claim 1, characterized in that, the piston cylinder includes a cylinder and a first piston fixed to one end of the cylinder, the side wall of the cylinder being provided with the second air outlet hole, the first piston being provided with an axial through hole, and the filter membrane being fixed inside the through hole; the piston rod includes a rod body, a second piston and a positioning column connected in sequence, the positioning column being detachably fitted with the through hole.

3. The infusion balloon catheter system according to claim 2, characterized in that, the positioning column and the through hole are in threaded fit.

4. The infusion balloon catheter system according to claim 3, characterized in that, the side wall at the top end of the through hole is provided with a threaded structure, and the filter membrane is fixed at the distal end of the through hole.

5. The infusion balloon catheter system according to claim 2, characterized in that, the outer wall of the cylinder is provided with an elastic buckle, and a clamping groove cooperating with the elastic buckle is provided inside the medicine container.

6. The infusion balloon catheter system according to claim 2, characterized in that, the aperture of the first air outlet hole is 5 - 10 mm; there are multiple second air outlet holes, and the aperture is 0.5 - 1.5 mm; the aperture of the through hole is 3 - 12 mm; the filter membrane is an ePTFE microporous membrane.

7. The infusion balloon catheter system according to claim 1, characterized in that, the medicine container is a cylindrical shape with an open top, including a bottom wall and a side wall, the bottom wall being provided with a liquid outlet hole, the side wall of the second chamber being provided with the liquid inlet hole, and the side wall of the first chamber being provided with the first air outlet hole.

8. The infusion balloon catheter system according to claim 1, characterized in that, the medicine container includes a cylinder with both ends open and an end cap detachably installed at one end of the cylinder, the piston assembly being slidably disposed inside the cylinder, and the end cap being provided with the medicine outlet hole.

9. The infusion balloon catheter system according to claim 1, characterized in that, the balloon catheter includes a balloon body and a catheter assembly, the medicine container being connected to the proximal end of the catheter assembly, and the wall of the balloon body being provided with a pore structure.

10. Infusion balloon catheter system, characterized in that, comprising: a balloon catheter having a proximal end and a distal end; a drug container connected to the proximal end of the balloon catheter, the drug container being provided with a drug outlet hole, a liquid inlet hole and a first air outlet hole, the drug outlet hole being connected to the balloon catheter; a piston assembly slidably disposed inside the drug container and dynamically dividing the interior of the drug container into a first chamber and a second chamber, the first air outlet hole communicating with the first chamber, the drug outlet hole and the liquid inlet hole both communicating with the second chamber, the piston assembly comprising a piston cylinder and a piston rod that are detachably engaged, the piston cylinder being provided with a second air outlet hole communicating with the first chamber, the piston assembly having a combined state in which the piston rod is fixed to the piston cylinder and a free state in which the piston rod can slide within the piston cylinder, in the free state, the piston rod slides to form a gas passage, and the piston cylinder is provided with a filter membrane capable of separating gas and liquid for discharging the gas in the second chamber through the gas passage and the first chamber; a drug contained in the drug container.

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