CN113577509A

CN113577509A - Medicine balloon

Info

Publication number: CN113577509A
Application number: CN202110664603.1A
Authority: CN
Inventors: 祁勇翔; 缪永生; 聂芳芳; 唐乃杰; 罗雷; 王阿玲; 霍勇
Original assignee: Shanghai Biomagic Medical Co ltd
Current assignee: Shanghai Biomagic Medical Co ltd
Priority date: 2021-06-16
Filing date: 2021-06-16
Publication date: 2021-11-02
Anticipated expiration: 2041-06-16
Also published as: CN113577509B

Abstract

The invention relates to the technical field of medical instruments and discloses a medicine balloon. The medicine balloon comprises a far-end cone part, a supporting part and a near-end cone part which are sequentially arranged, the supporting part is in a hollow cylindrical shape, and a plurality of micropores for medicine particle preparations to pass through are distributed on the surface of the supporting part; the distal end conical part comprises a first pipe part, a first conical part and a first flow passage which are coaxially arranged from far to near in sequence, and the first flow passage is an annular groove and is arranged between the maximum diameter edge of the first conical part and the distal end edge of the supporting part; the near-end conical part comprises a second pipe part, a second conical part and a second flow passage which are coaxially arranged from near to far, wherein the second flow passage is an annular groove and is arranged between the maximum diameter edge of the second conical part and the near-end edge of the supporting part. The invention improves the drug content in the vascular tissues corresponding to the two ends of the saccule, preventively treats the healthy vascular tissues outside the contact areas of the two ends of the saccule by drugs, eliminates or reduces the occurrence probability of restenosis and reduces the severity of lumen loss.

Description

Medicine balloon

Technical Field

The invention relates to the technical field of medical instruments, in particular to a medicine balloon.

Background

Cardiovascular and cerebrovascular diseases have become the first cause of death worldwide. Currently, there are several main treatments for ischemic heart disease: drug-based basic therapies, coronary bypass-based surgical therapies, coronary stent-based interventions, and drug balloon-based interventions. The above treatments all have shown significant results in the treatment of coronary stenosis, but each still has some significant problems.

The coronary stent implantation is to deliver a stent system to a target area in a puncture intervention mode, expand a balloon to release a stent, open a stenotic lesion blood vessel, recover blood supply and treat ischemic heart disease. However, the stent is in the human body for a long time, the body can be stimulated to generate immune rejection, smooth muscle cells are excessively proliferated to cause thickening of an inner membrane, so that the loss of a lumen is caused, the patency rate of the lumen is reduced, the blood supply is influenced, and the life health and safety of a patient are threatened. Therefore, for the restenosis lesion in the stent, a secondary interventional operation needs to be performed on the patient, the restenosis lesion blood vessel is supported again, the blood flow is recovered, and the life of the patient is saved.

The appearance of the drug balloon solves the problems of the coronary stent to a certain extent, and the drug released from the balloon acts on primary stenosis and restenosis to inhibit smooth muscle cell hyperproliferation and ensure the smoothness of the lumen. After the operation is finished, the medicine balloon system is withdrawn from the body, so that the permanent implantation of the instrument is avoided, and the risks of stent fracture, long-term thrombus and the like are eliminated.

The traditional medicine balloon is characterized in that a medicine coating is coated on the surface of a bare balloon, and after the balloon is pressurized, medicines contained in the coating contact and act on the inner wall of a blood vessel to inhibit cell proliferation, so that the traditional medicine balloon has the function of resisting intimal hyperplasia, and the long-term lumen smoothness of the blood vessel is ensured. However, conventional drug balloons also present some serious problems during design and use. First, the traditional drug balloon will close the blood vessel after being expanded in the blood vessel, and the blood flow cannot flow to the downstream through the blood vessel, so that the myocardial ischemia at the downstream of the coronary artery is caused, and the life of the patient is threatened. In order to reduce the problem of myocardial ischemia caused by artificial blood vessel closure as much as possible, the time for pressurizing the balloon is controlled within 1 minute. Simultaneously, reduce the time that the sacculus was pressurized and will directly influence the time of sacculus and vascular wall laminating, and then reduce the adhesion efficiency of medicine on the vascular surface, reduce the effective medicine content of vascular wall to influence the treatment effect of primary stenosis pathological change and restenosis pathological change. Secondly, the traditional medicine coating adopts a method of recrystallization after mixing the medicine and the carrier and is adhered to the surface of the saccule, when the saccule is pressurized, the crystallized coating is broken, the medicine is adhered to the blood vessel wall in a chip shape under the action of the carrier, the medicine is easy to fall off under the long-term impact of blood flow, and the long-term adhesion rate of the medicine is low. Moreover, in the process of delivery and release, the drug coating on the surface of the balloon can be partially peeled off under the action of blood flow impact and expansion pressure and then flows into blood, and partial coating can also be remained on the surface of the balloon when the balloon is withdrawn after pressure relief. Therefore, most of the medicine runs off in the operation process of the traditional medicine balloon, the amount of the medicine really acting on the blood vessel wall is small, the effective release rate of the medicine is low, and the treatment effect is influenced. Furthermore, the drug coating that is shed by conventional balloons during expansion and release is not soluble in blood, will be present in the form of large particles, and with blood flow to the distal small vessels, there is a significant risk of occlusion of the distal vessels. Finally, conventional drug balloons do not have any effective therapeutic effect on the blood vessels upstream and downstream of the treatment segment, and restenosis is more likely to occur in the region of the blood vessel in contact with the ends of the balloon, and the degree of stenosis is more severe.

In summary, for primary stenosis and restenosis, how to develop a drug balloon, when the balloon is pressurized, the balloon can reduce the expansion injury to the vessel wall, avoid the excessive hyperplasia of the intima, and prevent the occurrence of restenosis in the vessel; how to develop a new drug and carrier combination and release mode, so that the drug and carrier are retained on the vessel wall in a more stable and effective mode, and the long-term stable release of the drug is ensured; how to avoid or reduce the falling of a medicine coating and the residue on the surface of the balloon when the balloon is used for conveying, pressurizing and pressure relief, and improve the effective release rate of the medicine; how to avoid or reduce large particles caused by coating falling off when the saccule is conveyed and pressurized, and avoid or reduce the occurrence of far-end vascular embolism and acute myocardial infarction; how to increase the drug content in the vascular tissue corresponding to the two ends of the balloon without increasing the vascular injury area and obtain good long-term clinical effect is a problem which needs to be solved by the technicians in the field at present.

Disclosure of Invention

Based on the above, the present invention is directed to a drug balloon, so as to solve the above technical problems in the prior art.

In order to achieve the purpose, the invention adopts the following technical scheme:

a medicine balloon comprises a distal end cone part, a supporting part and a proximal end cone part which are arranged in sequence, wherein,

the supporting part is in a cylindrical shape with a hollow interior, the far end edge of the supporting part is connected with the far end conical part, the near end edge of the supporting part is connected with the near end conical part, and a plurality of micropores for the medicine particle preparation to pass through are distributed on the cylindrical surface of the supporting part;

the far-end conical part comprises a first pipe part, a first conical part and a first flow passage which are coaxially arranged from far to near, and the far end of the first pipe part is closed; the first conical part is conical, and the diameter of the first conical part is gradually increased from far to near; the first flow passage is an annular groove and is arranged between the maximum diameter edge of the first conical part and the far end edge of the supporting part;

the proximal end conical part comprises a second pipe part, a second conical part and a second flow passage which are coaxially arranged from near to far, and the second pipe part is communicated with an external medicine particle preparation and is used for inputting the medicine particle preparation into the supporting part; the second conical part is conical, and the diameter of the second conical part is gradually increased from the near to the far; the second flow passage is an annular groove and is arranged between the maximum diameter edge of the second conical part and the near end edge of the supporting part.

As a preferable mode of the drug balloon, the maximum diameter of the first tapered portion is greater than or equal to the inner diameter of the control blood vessel and less than or equal to the maximum outer diameter of the support portion, and the first flow channel is in contact with the inner wall of the control blood vessel in the circumferential direction only through the maximum diameter edge of the first tapered portion; and/or

The maximum diameter of the second conical part is larger than or equal to the inner diameter of the control blood vessel and smaller than or equal to the maximum outer diameter of the support part, and the second flow passage is in contact with the inner wall of the control blood vessel only through the maximum diameter edge of the second conical part in the circumferential direction.

As a preferable scheme of the medicine balloon, the first flow channel is an arc-shaped track with an open top end along the axial section of the medicine balloon, the arc-shaped track starts from the far end edge of the supporting part and ends at the edge with the largest diameter of the first conical part, the included angle between the tangent of the starting point of the arc-shaped track and the vertical line is sigma 1, 0 degrees and larger than or equal to sigma 1 and smaller than 90 degrees, the included angle between the tangent of the ending point of the arc-shaped track and the vertical line is sigma 2, and 0 degrees and larger than or equal to sigma 2 and smaller than 90 degrees; and/or

The second runner is followed medicine sacculus axial cross-section is top open-ended arc orbit, the arc orbit by the proximal end edge of supporting part is originated, ends in the maximum diameter edge of second toper portion, just contained angle is sigma 3 between the tangent line of the initial point of arc orbit and the vertical line, and 0 is no less than sigma 3 < 90 °, contained angle is sigma 4 between the tangent line of the termination point of arc orbit and the vertical line, and 0 is no less than sigma 4 < 90 °.

As a preferable scheme of the drug balloon, at least one micropore is arranged inside the first flow channel, and/or

At least one micropore is arranged in the second flow passage.

As a preferable scheme of the medicine balloon, at least one groove-shaped structure is distributed on the cylindrical surface between the far-end edge and the near-end edge of the supporting part, and the at least one groove-shaped structure is arrayed along the axial direction and/or the circumferential direction of the supporting part.

As a preferable scheme of the drug balloon, the groove-shaped structure is an annular groove extending along the circumferential direction of the support part, or an arc-shaped groove extending along the circumferential direction of the support part, or a long straight groove extending along the axial direction of the support part, or a rectangular groove parallel to the axial direction of the support part; the groove-shaped structures are mutually communicated or not communicated.

As a preferable scheme of the drug balloon, the micropores are opened on the surface of the convex structures between the groove-shaped structures of the supporting part, and/or the micropores are opened in the groove-shaped structures of the supporting part.

As a preferable scheme of the drug balloon, the proportion of the sum of the surface areas of blank blood vessels corresponding to each groove-shaped structure on the surface of the supporting part in the surface area of the blood vessel with the target length is 0-80%.

As a preferable scheme of the medicine balloon, the surfaces of the supporting parts close to the positions of the far end edge and the near end edge of the supporting parts are all circular ring-shaped bulges.

As a preferable mode of the drug balloon, the farthest end point of the contour of a row of the micropores closest to the distal edge of the support part is 0.001-1.0mm from the distal edge of the support part; and/or

The nearest end point of the outline of the row of the micropores closest to the proximal edge of the support part is 0.001-1.0mm from the proximal edge of the support part.

As a preferable scheme of the drug balloon, the pore diameter of the micropores is 1-100 μm, and the particle size of the drug particles in the drug particle preparation is 1-999 nm.

The invention has the beneficial effects that:

according to the invention, the cylindrical surface of the supporting part is contacted with the inner wall of the blood vessel, the supporting part is provided with a plurality of micropores, and when the blood vessel is pressurized, the medicine particle preparation flows out through the micropores and is adhered or inlaid on the inner wall of the blood vessel, so that the medicine particle preparation can slowly release the medicine on the inner wall of the blood vessel, the excessive hyperplasia of the intima is inhibited, and the occurrence of restenosis is avoided or reduced; and when the drug balloon is used for conveying, pressurizing and releasing pressure, the problems of falling off and residue of a drug coating do not exist, the effective release rate of the drug is greatly improved, and the problems of far-end vascular embolism, acute myocardial infarction and the like caused by the falling off of the coating are avoided.

According to the invention, the first flow channel is arranged at the far end of the medicine balloon, the second flow channel is arranged at the near end of the medicine balloon, so that the liquid medicine flows from the micropores on the surface of the supporting part and flows to the two ends along the contact surface of the supporting part and the inner wall of the blood vessel, part of the liquid medicine stays in the first flow channel and the second flow channel, the liquid medicine is in contact with the inner wall of the blood vessel and moistens the blood vessel tissue, the excessive hyperplasia of the intima is inhibited, and the occurrence of restenosis is avoided or reduced; moreover, because the edges of the first flow channel and the second flow channel can be regarded as narrow annular belt-shaped tracks, the contact area with the inner wall of the blood vessel is small and can be almost ignored, the expansion injury to the blood vessel wall can be ignored, and other parts of the first flow channel and the second flow channel are not in contact with the inner wall of the blood vessel at all, and the inflammatory reaction of the tissue of the blood vessel wall caused by the expansion of the saccule can not occur. Therefore, the first flow channel and the second flow channel at the two ends of the medicine balloon improve the medicine content in the blood vessel tissues corresponding to the two ends of the balloon on the basis of ensuring that the blood vessel damage area caused by balloon expansion is not increased, and the medicine treatment is performed on the healthy blood vessel tissues outside the contact areas at the two ends of the balloon in a preventive manner, so that the occurrence probability of restenosis is eliminated or reduced, and the severity of lumen loss is reduced.

Drawings

In order to more clearly illustrate the technical solutions in the embodiments of the present invention, the drawings used in the description of the embodiments of the present invention will be briefly described below, and it is obvious that the drawings in the following description are only some embodiments of the present invention, and for those skilled in the art, other drawings can be obtained according to the contents of the embodiments of the present invention and the drawings without creative efforts.

Fig. 1 is a schematic structural diagram of a drug balloon provided in an embodiment of the present invention;

fig. 2 is a front view of a drug balloon provided in accordance with an embodiment of the present invention;

FIG. 3 is an enlarged view of the distal end of the drug balloon of FIG. 2;

FIG. 4 is an enlarged view of the structure of FIG. 3 at the first flow passage;

FIG. 5 is a partial view of the distal end of a drug balloon applied to a blood vessel (the direction of the arrows indicate the direction of flow of the drug solution) provided by one embodiment of the present invention;

FIG. 6 is an enlarged view of the proximal end structure of the drug balloon of FIG. 2;

FIG. 7 is an enlarged view of the structure of FIG. 6 at the second flow passage;

FIG. 8 is an enlarged view of the second flow passage of FIG. 6;

fig. 9 is a proximal partial view of a drug balloon applied to a blood vessel (the direction of the arrows indicate the flow direction of the drug) according to an embodiment of the present invention;

fig. 10 is a schematic structural diagram of a drug balloon provided in the second embodiment of the present invention;

fig. 11 is a front view of a drug balloon provided in accordance with example two of the present invention;

FIG. 12 is an enlarged view of a portion of the drug balloon of FIG. 11;

fig. 13 is a schematic structural diagram of a drug balloon provided in the third embodiment of the present invention;

fig. 14 is a front view of a drug balloon provided in accordance with a third embodiment of the present invention;

FIG. 15 is an enlarged view of a portion of the drug balloon of FIG. 14;

fig. 16 is a schematic structural diagram of a drug balloon provided in the fourth embodiment of the present invention;

fig. 17 is a front view of a drug balloon provided in accordance with a fourth embodiment of the present invention;

FIG. 18 is an enlarged view of a portion of the drug balloon of FIG. 17;

fig. 19 is a schematic structural diagram of a drug balloon provided in the fifth embodiment of the present invention;

fig. 20 is a front view of a drug balloon provided in accordance with example five of the present invention;

FIG. 21 is an enlarged view of a portion of the drug balloon of FIG. 20;

fig. 22 is a schematic structural diagram of a drug balloon provided in a sixth embodiment of the present invention;

fig. 23 is a front view of a drug balloon provided by a sixth embodiment of the present invention;

FIG. 24 is an enlarged view of a portion of the drug balloon of FIG. 23;

fig. 25 is an image of a prior art DSA contrast follow-up after implantation of a stent into a blood vessel.

The reference numbers in the figures are as follows:

100-a drug balloon; 110-a distal taper; 1101-a first pipe portion; 1102-a first taper; 11021-first edge; 1103 — a first flow channel; 120-a support; 1201-distal edge; 1202-raised structures; 1203-micro wells; 1204-a slot-type configuration; 1209-proximal edge; 130-a proximal taper; 1301-a second pipe portion; 1302-a second tapered portion; 13021-second edge; 1303-a second flow channel; 30-a blood vessel; 301-inner wall of blood vessel.

Detailed Description

The present invention will be described in further detail with reference to the accompanying drawings and examples. It is to be understood that the specific embodiments described herein are merely illustrative of the invention and are not limiting of the invention. It should be further noted that, for the convenience of description, only some of the structures related to the present invention are shown in the drawings, not all of the structures.

In the description of the present invention, unless expressly stated or limited otherwise, the terms "connected," "connected," and "fixed" are to be construed broadly, e.g., as meaning permanently connected, removably connected, or integral to one another; can be mechanically or electrically connected; either directly or indirectly through intervening media, either internally or in any other relationship. The specific meanings of the above terms in the present invention can be understood in specific cases to those skilled in the art.

In the present invention, unless otherwise expressly stated or limited, "above" or "below" a first feature means that the first and second features are in direct contact, or that the first and second features are not in direct contact but are in contact with each other via another feature therebetween. Also, the first feature being "on," "above" and "over" the second feature includes the first feature being directly on and obliquely above the second feature, or merely indicating that the first feature is at a higher level than the second feature. A first feature being "under," "below," and "beneath" a second feature includes the first feature being directly under and obliquely below the second feature, or simply meaning that the first feature is at a lesser elevation than the second feature.

In the description of the present embodiment, the terms "upper", "lower", "left", "right", and the like are used based on the orientations and positional relationships shown in the drawings only for convenience of description and simplification of operation, and do not indicate or imply that the referred device or element must have a specific orientation, be configured and operated in a specific orientation, and thus, should not be construed as limiting the present invention. Furthermore, the terms "first" and "second" are used only for descriptive purposes and are not intended to have a special meaning.

Example one

As shown in fig. 1-9, the present embodiment provides a drug balloon 100, which includes a distal cone portion 110, a support portion 120 and a proximal cone portion 130 connected in sequence from the distal end to the proximal end. The supporting portion 120 is a hollow cylinder, and the inner cavity of the supporting portion is used for accommodating a liquid medicine for treating diseases. The distal edge 1201 of the support part 120 is connected to the distal pyramid part 110, the proximal edge 1209 of the support part 120 is connected to the proximal pyramid part 130, a plurality of micropores 1203 are distributed on the cylindrical surface of the support part 120, and the drug particle preparation contained in the support part 120 can flow out or be ejected at high speed to the blood vessel 30 through the micropores 1203, so that the drug particles can stably stay in the target lesion tissue. Preferably, the micropores 1203 of this embodiment are small holes with a diameter in the order of micrometers. Further preferably, the plurality of micropores 1203 of the present embodiment are uniformly distributed at intervals in the circumferential direction and the axial direction on the surface of the supporting portion 120, so that the drug microparticle preparation can more uniformly flow out or be sprayed from the drug balloon 100 to the vascular lesion tissue.

The distal end tapered portion 110 of the present embodiment has a hollow tubular structure as a whole, and includes a first tube portion 1101, a first tapered portion 1102, and a first flow passage 1103, which are coaxially provided in this order from the distal end to the proximal end. The first tube portion 1101 is cylindrical and closed at the distal end, and the first tube portion 1101 is a thin-walled tubular structure of smaller diameter (this portion is outside the balloon-forming region during processing, thus preserving the form and size of the original balloon tubing). The first tapered portion 1102 has a conical shape, the diameter of which gradually increases from the far to the near, and the projection locus thereof may be an oblique straight line, a hyperbolic curve, an exponential line, or the like. The first flow channel 1103 is an annular groove circumferentially symmetrical about the balloon central axis, and is disposed between the maximum diameter edge (i.e., first edge 11021) of the first tapered portion 1102 and the distal edge 1201 of the support portion 120. The design of the first flow channel 1103 in the form of a circumferentially symmetric annular groove is to allow the corresponding healthy blood vessel wall to have a liquid medicine effect in the complete circumferential direction, and the liquid medicines in the annular groove circulate each other, so that the concentrations of the medicines are approximately the same, and the excessive proliferation of the blood vessel smooth muscle cells in the corresponding region can be uniformly inhibited, and the occurrence of intimal hyperplasia can be reduced.

The proximal tapered portion 130 of the present embodiment is also hollow and tubular, and includes a second tube 1301, a second tapered portion 1302, and a second flow channel 1303 coaxially disposed in this order from the proximal side to the distal side. The second tube part 1301 has a cylindrical shape and communicates with the external medicine fine particle preparation for inputting the external medicine fine particle preparation to the inside of the support part 120; the second tube portion 1301 is a thin-walled tubular structure of smaller diameter (this portion is outside the balloon-forming region during processing, thus maintaining the shape and dimensions of the original balloon tubing). The second tapered portion 1302 has a conical shape with a diameter gradually increasing from the proximal portion to the distal portion, and the projection locus thereof may be an oblique straight line, a hyperbolic curve, an exponential line, or the like. The second flow channels 1303 are annular grooves circumferentially symmetric about the balloon central axis and are disposed between the largest diameter edge of the second tapered portion 1302 (i.e., the second edge 13021) and the proximal edge 1209 of the support portion 120. The principle and effect of the second flow channel 1303 configured as a circular groove with a circular symmetry can be referred to the description of the first flow channel 1103, and the description of this embodiment is omitted.

According to the invention, the medicine particle preparation is released to the inner wall 301 of the blood vessel through the micropores 1203 formed on the surface of the supporting part 120, so that the medicine can be more stably and effectively retained on the inner wall 301 of the blood vessel, the medicine can be stably released for a long time, the excessive hyperplasia of the intima is inhibited, and the occurrence of restenosis is avoided or reduced. Moreover, when the drug balloon 100 is used for conveying, pressurizing and pressure relief, the problems of falling off and residue of a drug coating do not exist, and the effective release rate of the drug is greatly improved; meanwhile, the problems of distal vascular embolism, acute myocardial infarction and the like caused by the falling of the coating are avoided. In addition, after the liquid medicine flows out from the micropores 1203 of the support part 120, the liquid medicine flows towards two ends along the contact surface between the outer surface of the support part 120 and the inner wall 301 of the blood vessel, the liquid medicine flowing out of the conventional porous medicine balloon flows into the blood directly without stopping after flowing through the contact surface between the balloon and the blood vessel, no effective treatment effect is exerted on the blood vessel at the upstream and downstream of the treatment section, the restenosis lesion is more easily generated in the blood vessel area contacted with the two ends of the balloon, and the stenosis degree is more serious.

Therefore, according to the invention, the first flow channel 1103 is arranged on the distal cone part 110, the second flow channel 1303 is arranged on the proximal cone part 130, when the balloon is inflated, a space similar to a closed space can be formed between the first flow channel 1103 and the inner wall 301 of the blood vessel and between the second flow channel 1303 and the inner wall 301 of the blood vessel, and a part of the liquid medicine stays in the closed space after flowing through the contact surface between the balloon and the blood vessel 30. The liquid medicine contacts with the inner wall 301 of the blood vessel in the closed space and moistens the blood vessel tissue, and the medicine particles are adhered or embedded on the inner wall 301 of the blood vessel to slowly release the medicine, inhibit the excessive hyperplasia of the intima and avoid or reduce the occurrence of restenosis.

Further, in the present embodiment, the maximum diameter of the first tapered portion 1102 (i.e., the diameter of the first edge 11021) is greater than or equal to the inner diameter of the control blood vessel 30 and less than or equal to the maximum outer diameter of the support portion 120, and the first flow channel 1103 contacts the inner wall of the control blood vessel 30 only through the first edge 11021 of the first tapered portion 1102 in the circumferential direction. Specifically, in the present embodiment, the difference between the diameter of the first rim 11021 and the inner diameter of the control blood vessel 30 is in the range of 0 to 1mm, preferably 0.01 to 0.5mm, and more preferably 0.1 to 0.3 mm. With such a configuration, the lower limit of 0mm is to ensure that the first edge 11021 contacts the inner wall 301 of the blood vessel, and a quasi-closed space can be formed between the first flow channel 1103 and the inner wall 301 of the blood vessel, otherwise, the retention time of the liquid medicine flowing into the quasi-closed space formed between the first flow channel 1103 and the inner wall 301 of the blood vessel is too short, and the liquid medicine is liable to rapidly flow out through the first edge 11021, so that the contact time of the medicine and the inner wall 301 of the blood vessel is too short, and the effect of the medicine in inhibiting smooth muscle cell proliferation and restenosis in the blood vessel is affected. The lower limit of 0.01mm is set based on the measurement and recognition accuracy of the conventional DSA contrast apparatus and OCT imaging apparatus used clinically, which is 0.01mm, for example, the size of a reference blood vessel is 2.98mm, and only 2 decimal places are displayed. The lower limit of 0.1mm is set based on the consideration of the operation error of the size measurement performed by the doctor in clinic. The upper limits of 0.3mm, 0.5mm and 1.0mm are set based on the diameter difference between the balloon support 120 and the control blood vessel 30 during clinical operation, the smaller the difference is, the smaller the injury to the blood vessel is, the larger the difference is, the more the balloon expands the blood vessel, the larger the injury to the blood vessel is, and the higher the risk of smooth muscle cell proliferation and restenosis is. In addition, in the present embodiment, the maximum diameter of the first edge 11021 is set to be smaller than or equal to the maximum outer diameter of the support portion 120, based on the assumption that the damage to the blood vessel inner wall 301 when the first edge 11021 is expanded is reduced as much as possible, and when the diameter of the first edge 11021 is not larger than the outer diameter of the support portion 120, the damage to the blood vessel wall by the first edge 11021 of the same width is certainly not larger than the damage to the blood vessel wall by the support portion 120 of the same width.

The width of the first edge 11021 is 0.001 to 2.0mm, preferably 0.01 to 1.0mm, and more preferably 0.2 to 0.5 mm. The reason why the width is set to be very narrow is to reduce the contact area between the first edge 11021 and the inner wall 301 of the blood vessel as much as possible, and the smaller the contact area is, the smaller the expansion damage to the inner wall 301 of the blood vessel becomes, and the smaller the probability of occurrence of the restenosis at the distal end of the treatment segment becomes. In this embodiment, the preferred range of 0.2-0.5mm is described above, where 0.2mm is determined based on the fact that the balloon wall thickness is conventionally around 0.1mm, while the width of the structure at the first edge 11021 is often made up of the balloon wall thickness at both sides and the middle gap, so engineering optimality defines the width of the first edge 11021 as greater than 0.2 mm; the 0.5mm is determined to minimize the width of the first edge 11021 and reduce damage to the vessel wall. In this embodiment, since the first edge 11021 is a circular band-shaped track with a narrow width, and the contact area between the first edge 11021 and the inner wall 301 of the blood vessel is small and almost negligible, the expansion injury to the blood vessel wall can be ignored; other structures of the first flow channel 1103 are not in contact with the inner wall 301 of the blood vessel at all, so that the inflammatory reaction of the tissue of the blood vessel wall due to the expansion of the balloon does not occur.

Similarly, the maximum diameter (i.e., the second edge 13021) of the second tapered portion 1302 of the present embodiment is greater than or equal to the inner diameter of the control blood vessel 30 and less than or equal to the maximum outer diameter of the support portion 120, and the second flow channel 1303 is in contact with the inner wall of the control blood vessel 30 only through the second edge 13021 of the second tapered portion 1302 in the circumferential direction. Further, the diameter of the second margin 13021 minus the inner diameter of the control vessel 30 in this embodiment is in the range of 0-1mm, preferably 0.01-0.5mm, and more preferably 0.1-0.3 mm. The width of the second edge 13021 is 0.001-2.0mm, preferably 0.01-1.0mm, and more preferably 0.2-0.5 mm. The principle and effect of the above arrangement can be referred to the description of the first edge 11021, and the description of the embodiment is omitted.

In summary, in the present embodiment, the first flow channel 1103 structure disposed on the distal cone portion 110 and the second flow channel 1303 disposed on the proximal cone portion 130, on the basis of ensuring that the damaged area of the blood vessel 30 caused by the expansion of the balloon is not increased, the healthy blood vessel tissue outside the contact area of the two ends of the balloon is treated with drugs in a preventive manner, so as to eliminate or reduce the occurrence rate of restenosis and reduce the severity of lumen loss.

In this embodiment, the material of the drug balloon 100 may be one or more of nylon, modified nylon, nylon elastomer, and linear low density polyethylene. The drug balloon 100 may be integrally blow-molded or 3D printed, or the distal cone portion 110, the support portion 120, and the proximal cone portion 130 may be blow-molded separately and then the three portions may be joined by laser welding or hot-melt welding. The micro-holes 1203 may be processed by laser drilling several hundred micro-scale holes on the surface of the support 120. Of course, in other embodiments, other materials and processing methods may be used to manufacture the drug balloon 100, and the present embodiment is not limited thereto.

Optionally, in this embodiment, the axial distance between the first edge 11021 and the distal edge 1201 is 0-4mm, preferably 0.1-3mm, and more preferably 0.5-2 mm. This axial distance determines the length range of the drug solution remaining in the first flow channel 1103 in contact with the blood vessel wall, and if it is too short, sufficient contact between the distal blood vessel and the drug solution cannot be ensured, and the total amount of the drug in contact with the blood vessel not in contact with the balloon near the distal end of the balloon and the area to be nourished by the drug solution are insufficient, and the effect of inhibiting the smooth muscle cells and the restenosis in the blood vessel is affected, and therefore the distance is optimized to be greater than 0.5 mm. However, since the first flow channel 1103 has no supporting capability, if the distance is too long, the first flow channel 1103 is easy to bend in the blood vessel, so that the first edge 11021 is not in close contact with the blood vessel wall, the residence time of the liquid medicine after flowing into the quasi-closed space formed between the first flow channel 1103 and the inner wall 301 of the blood vessel is too short, the outflow speed from the first edge 11021 is too fast, and the contact time of the medicine with the inner wall 301 of the blood vessel is too short, thereby affecting the effect of the medicine in inhibiting smooth muscle cell proliferation and restenosis in the blood vessel, and therefore, the upper limits of the distances of 4mm, 3mm and 2mm are set in this embodiment, respectively. Similarly, in this embodiment, the axial distance between the second edge 13021 and the proximal edge 1209 is also 0-4mm, preferably 0.1-3mm, and further preferably 0.5-2mm, and the reason for setting the axial distance is the same as the reason for setting the axial distance between the first edge 11021 and the distal edge 1201, and is not described again in this embodiment.

Preferably, as shown in fig. 3-5, the first flow channel 1103 of the present embodiment has an arc-shaped track with an open top end in a cross section along the axial direction of the drug balloon 100, the arc-shaped track starts from the distal edge 1201 of the supporting portion 120 and ends at the first edge 11021 of the first tapered portion 1102, and the tangent to the starting point of the arc-shaped track forms an included angle σ 1 with the vertical line, 0 ° ≦ σ 1 < 90 °, and more preferably, 0 ° ≦ σ 1 < 45 °. With this arrangement, the liquid medicine can smoothly flow into the first flow channel 1103 along the tangential direction of the starting point of the trajectory after flowing through the contact surface between the surface of the supporting portion 120 and the blood vessel wall. The initial direction of the fluid flows to the bottom of the first flow channel 1103, and then the liquid medicine staying at the bottom of the first flow channel 1103 is continuously taken away from the bottom, and then the blood vessel wall tissue is impacted reversely, so that the effective contact between the medicine and the blood vessel inner wall 301 is ensured, and the tight fit between the blood vessel inner wall 301 and the supporting part 120 is not influenced. In addition, the included angle between the tangent line of the ending point of the arc-shaped track and the vertical line is sigma 2, sigma 2 is more than or equal to 0 degrees and less than 90 degrees, and by the arrangement, after the liquid medicine flows into the first flow channel 1103 along the starting point of the track, the liquid medicine can rotate back along the ending point of the track again and repeats; as the medical fluid accumulates, the end of the trajectory disengages from the inner wall 301 of the blood vessel, opening an opening through which excess fluid flows into the blood. In summary, in the present embodiment, after the liquid flowing out through the contact surface between the supporting portion 120 and the inner wall 301 of the blood vessel enters the first flow channel 1103, it is ensured that the new and old inflowing liquid medicines all have a chance to contact the inner wall 301 of the blood vessel, so as to prevent the liquid medicine at the bottom of the first flow channel 1103 from staying in the bottom space all the time, and the liquid medicine circulates and increases the staying time in the space, thereby increasing the chance of the liquid medicine contacting the inner wall 301 of the blood vessel, and allowing as much medicine as possible to stay in the target blood vessel tissue.

Further, as shown in fig. 6-9, the second flow path 1303 of the present embodiment also has an open-topped curved trajectory in a cross section along the axial direction of the drug balloon 100, the curved trajectory is initiated by the proximal edge 1209 of the support portion 120 and terminated by the second edge 13021 of the second taper portion 1302, and a tangent to the beginning of the curved trajectory forms an angle σ 3 with the vertical, where 0 ° ≦ σ 3 < 90 °, and more preferably, 0 ° ≦ σ 3 < 45 °. With this arrangement, the liquid medicine can smoothly flow into the second flow channel 1303 along the tangential direction of the starting point of the trajectory after flowing through the contact surface between the surface of the supporting portion 120 and the inner wall 301 of the blood vessel. The initial direction of the fluid flows to the bottom of the second flow channel 1303, and then the liquid medicine staying at the bottom of the second flow channel 1303 is continuously taken away from the bottom, and then the blood vessel wall tissue is reversely impacted, so that the effective contact between the medicine and the blood vessel inner wall 301 is ensured, and the tight fit between the blood vessel inner wall 301 and the supporting part 120 is not influenced. In addition, the included angle between the tangent line of the ending point of the arc-shaped track and the vertical line is sigma 4, sigma 4 is more than or equal to 0 degrees and less than 90 degrees, and the liquid medicine flows into the second flow channel 1303 along the starting point of the track, then rotates back along the ending point of the track, and repeats; as the medical fluid accumulates, the end of the trajectory disengages from the inner wall 301 of the blood vessel, opening an opening through which excess fluid flows into the blood. In summary, in this embodiment, after the liquid flowing out through the contact surface between the balloon supporting portion 120 and the inner wall 301 of the blood vessel enters the second flow channel 1303, it is ensured that the new and old inflowing liquid medicines all have a chance to contact the inner wall 301 of the blood vessel, so as to prevent the liquid medicine at the bottom of the second flow channel 1303 from staying in the bottom space all the time, and the liquid medicine circulates and increases the staying time in the space, and the chance of contact between the liquid medicine and the inner wall 301 of the blood vessel is increased, so that as much medicine as possible can stay in the target blood vessel tissue.

Preferably, in this embodiment, at least one micro hole 1203 may be disposed inside the first flow channel 1103 and/or inside the second flow channel 1303. Due to the arrangement, the medicine particle preparation can directly enter the first flow passage 1103 and/or the second flow passage 1303 through the micropores 1203, the content of the liquid medicine in the first flow passage 1103 and/or the second flow passage 1303 is further ensured, and the treatment effect on two ends of the pathological tissue is improved.

Further, in this embodiment, the distance from the farthest end point of the contour of the row of micro holes 1203 closest to the distal edge 1201 of the supporting portion 120 is 0.001-1.0mm, more preferably 0.01-0.1mm, and still more preferably 0.2-0.5 mm. The reason why the distance is controlled to be very small in this embodiment is to make the farthest micro-hole 1203 as close as possible to the farthest end of the blood vessel inner wall 301 which is in close contact with the support portion 120. Thus, the drug particles that flow out through the micropores 1203 may directly act on the most distal site of the damaged vascular tissue due to balloon expansion, along with the high pressure fluid. That is, micropores 1203 are directly distributed on the balloon part which causes the expansion injury to the blood vessel wall, so as to release the nano-drug and inhibit the occurrence of intimal hyperplasia and restenosis caused by the expansion injury. Exemplarily, assuming that the length of the supporting portion 120 is 20mm, the length of the blood vessel tissue segment contacted with the supporting portion 120 is considered to be 20mm, i.e., the length of the blood vessel tissue segment damaged by balloon dilatation is 20 mm. If the distance from the farthest point of the contour of the distal micro-hole 1203 to the distal edge 1201 of the support 120 is set to 0.001-1.0mm (more preferably 0.01-0.1 mm), it is considered that the length of the damaged segment of vascular tissue affected by the high concentration drug is 20mm, that is, the micro-hole 1203 directly corresponds to the length of the 20mm vascular tissue, which means that the high concentration nano-drug solution directly acts on the segment of vascular tissue. On the other hand, if there is no micro-hole 1203 directly corresponding to both ends of the vascular tissue, it means that the drug solution needs to flow from the side micro-hole 1203 to the edge of the balloon, and in the whole process, the drug content in the tissue at the edge position of both ends of the injured blood vessel is inevitably reduced due to the absorption of the drug by the vascular tissue, and the reduction of the drug concentration in the tissue means that the resistance to the intimal hyperplasia and the restenosis of the blood vessel is reduced. That is, if the distance from the farthest point of the contour of the distal micro-hole 1203 to the distal edge 1201 is greater than 1.0mm, it is considered that the length of the damaged segment of the blood vessel affected by the high concentration drug is less than 20mm, and the portion of the damaged blood vessel not affected by the high concentration drug is more likely to suffer from intimal hyperplasia, and then the condition of intravascular restenosis occurs. Of course, it should be noted that the distance is not suitable for being too small, and if the distance is less than 0.01mm, i.e., 10 μm, it is difficult to control the accuracy of the form and position tolerance of the laser drilling, and the accuracy of the distal end edge line of the support portion 120 is also required to be too high when the balloon is molded.

Further, in this embodiment, the distance from the nearest end point of the contour of the row of micro holes 1203 closest to the proximal edge 1209 of the supporting portion 120 is also 0.001-1.0mm, more preferably 0.01-0.1mm, and even more preferably 0.2-0.5mm, for the specific setting reason and effect, refer to the above explanation about the micro holes 1203 at the distal edge 1201, and this embodiment is not repeated.

Preferably, in this embodiment, the micropores 1203 distributed on the supporting portion 120 are cylindrical micropores, and the pore diameter thereof is 1-100 μm, and more preferably 2-20 μm. The design basis of the diameter range is as follows: if the aperture is too small, the drug particles at the existing level can not pass through the small holes smoothly; if the aperture is too large, the liquid flow is too large, the operation process is difficult to operate, meanwhile, the jet impact force under high pressure is too large, the blood vessel is easy to be damaged, and the balloon is easy to rupture under high pressure due to too large aperture.

In this embodiment, the drug microparticle formulation comprises: the medicine particles are evenly and stably distributed in the solvent in a suspension state at room temperature. Compared with the traditional medicine balloon 100, the surface of the medicine balloon 100 in the invention is not provided with a medicine coating, so that the medicine loss is avoided in the balloon conveying and pressurizing opening processes, meanwhile, the medicine particle carrier has better adhesion performance to the vessel wall, the medicine release efficiency is improved, and meanwhile, the occurrence of far-end embolism and acute myocardial infarction caused by the falling of large particles of the medicine coating is avoided.

In this embodiment, the maximum size of the drug particles should be smaller than the diameter of the micropores 1203. Preferably, the particle size of the drug particles in the drug particle preparation is 1 to 999 nm. Because the maximum diameter of the drug particles is less than 1 micron, compared with the bulk coating of the conventional drug balloon 100, the sum of the surface areas of all the drug particles is far greater than the surface area of the drug coating of the conventional drug balloon 100 under the condition of the same total drug loading, that is, the real contact area between the drug particles and the blood vessel wall is far greater than that of the conventional drug balloon 100. Considering that the larger the real contact area with the vascular wall, the higher the overall adhesion efficiency of the drug on the vascular wall, therefore under the condition that the initial total amount of the drug is the same, compared with the traditional drug balloon 100, the drug particle preparation can lead the drug amount adhered on the target vascular wall to be more, the drug concentration in the tissue is higher, the effect of inhibiting the excessive proliferation of smooth muscle cells is better, and the patency rate of the long-term lumen is higher.

Specifically, the form of the drug particles in this embodiment may be microspheres, liposomes, solid crystals, micelles, and the like. Further, the drug microparticles of the present embodiment comprise a drug and a carrier; the drug can be one or more of nimustine, carmustine, 5-fluorouracil, fluoroguanosine, gemcitabine, daunorubicin, doxorubicin, paclitaxel, vinblastine, topotecan, aminoglutethimide, sirolimus, everolimus, rapamycin and zotarolimus; the carrier can be one or more of racemic polylactic acid, polyethylene glycol, magnesium stearate, iohexol, iopromide, urea, sorbitol, polysorbitol, polyoxyethylene polyoxypropylene ether block copolymer, trihexyl citrate, phospholipid, matrix of ropiperazine, polylactic acid-glycolic acid copolymer, polyvinylpyrrolidone, cholesterol, vitamin E, and vitamin E polyethylene glycol succinate.

Example two

The present embodiment provides another drug balloon 100, which has a structure substantially similar to the drug balloon 100 of the first embodiment, and also includes a distal cone portion 110, a supporting portion 120, and a proximal cone portion 130, which are sequentially connected from far to near, wherein the distal cone portion 110 is provided with a first flow channel 1103, the supporting portion 120 is provided with a plurality of micropores 1203 for passing the drug microparticle preparation, and the proximal cone portion 130 is provided with a second flow channel 1303. For simplicity, the present embodiment only describes the differences from the first embodiment.

As shown in fig. 10 to 12, the present embodiment is different from the first embodiment in that: at least one groove-shaped structure 1204 is distributed on the cylindrical surface between the far end edge 1201 and the near end edge 1209 of the support part 120, and the at least one groove-shaped structure 1204 is arrayed along the axial direction and/or the circumferential direction of the support part 120, and a convex structure 1202 is formed between the groove-shaped structures 1204.

In this embodiment, the design purpose of the slot-shaped structure 1204 is two: first, when the balloon is inflated, the drug solution containing the drug flows out of the micropores 1203, and then spreads around the center of the micropores 1203. After the liquid medicine flows into the groove-shaped structure 1204, the groove-shaped structure 1204 is gradually filled with the liquid medicine, the liquid medicine can be always contacted with the blood vessel tissue of a lesion section in the balloon expansion time, and the medicine can also be adsorbed and acted on the target blood vessel tissue to inhibit the occurrence of intimal hyperplasia and restenosis. Second, during the sacculus expansion, the cell type structure 1204 on the supporting part 120 does not take place solid atress contact between with the target vascular tissue, and during the sacculus expansion promptly, the cell type structure 1204 on the supporting part 120 can not form effective expansion to the vascular wall, and target vascular inner wall is equivalent to unsettled, can not cause serious expansion damage to the vascular wall yet naturally to reduced the expansion damage regional area that the supporting part 120 caused to vascular inner wall 301, the intimal hyperplasia that comes along and restenosis also just are reduced to the minimum. To sum up, when the balloon is expanded, the groove-shaped structure 1204 on the supporting portion 120 minimizes the damage to the vessel wall as much as possible, and the liquid medicine filled inside acts on the target vessel tissue to suppress intimal hyperplasia and prevent restenosis.

Preferably, the supporting portion 120 of the present embodiment is provided with a plurality of groove-shaped structures 1204, wherein a plurality of groove-shaped structures 1204 are annular grooves extending along the circumferential direction of the supporting portion 120, and the remaining plurality of groove-shaped structures 1204 are long straight grooves extending along the axial direction of the supporting portion 120, and the annular grooves and the long straight grooves are mutually cross-communicated, that is, the liquid medicine stored in each groove-shaped structure 1204 of the present embodiment can mutually circulate. The reason for this is that when the drug solution flows through the vascular tissue, part of the drug is absorbed by the vascular tissue, resulting in a decrease in the drug concentration in the drug solution passing through the vascular tissue region; the communicated groove-shaped structures 1204 can enable liquid medicines with different medicine concentrations in the grooves to be mixed with each other, ensure that the concentration of the liquid medicines is close to be consistent, ensure that the concentration of the liquid medicines nourishing the corresponding vascular tissues in the groove-shaped structures 1204 is consistent as much as possible, and ensure that the liquid medicines are at a relatively high level, thereby effectively inhibiting the proliferation of smooth muscle cells and the restenosis in blood vessels.

It should be noted that when the groove-shaped structure 1204 is disposed on the surface of the support portion 120, the surface of the support portion 120 near the distal edge 1201 and the proximal edge 1209 with the micropores 1203 is a complete cylindrical surface in the circumferential direction, and the groove-shaped structure 1204 is not disposed (that is, the surface of the support portion 120 near the distal edge 1201 and the proximal edge 1209 are all circular ring-shaped protrusions), otherwise, the medical fluid in the groove-shaped structure 1204 may flow into the blood when the balloon is pressurized, thereby reducing the therapeutic effect on the inner wall 301 of the blood vessel. Therefore, the purpose of the above-mentioned arrangement of the present embodiment is to form a closed space between the groove-shaped structure 1204 and the inner wall 301 of the blood vessel, and not to communicate with the blood flow outside the balloon.

Preferably, in this embodiment, the micro holes 1203 are preferably opened on the surface of the protruding structure 1202 formed between the groove-shaped structures 1204 of the supporting portion 120, so that the liquid medicine can directly act on the target blood vessel tissue after flowing out through the micro holes 1203, and the treatment effect is enhanced. Certainly, in this embodiment, micropores 1203 of a micron level may also be distributed on the bottom surface of the groove-shaped structure 1204, and the micropores 1203 distributed at the bottom surface position may allow the liquid medicine to directly spray and impact on the inner wall 301 of the blood vessel through the micropores 1203 when the balloon is pressurized, so as to enhance the therapeutic effect on the inner wall 301 of the blood vessel, and the liquid medicine may fill the groove-shaped structure 1204 through the micropores 1203 and act on the suspended blood vessel wall, thereby inhibiting intimal hyperplasia and preventing restenosis. In addition, in this embodiment, the micro-holes 1203 of micron level may be distributed on the inner side surface of the groove-shaped structure 1204, so as to achieve the effect of directly filling the groove-shaped structure 1204 with the liquid medicine, thereby facilitating the inhibition of intimal hyperplasia and preventing restenosis.

Further, in this embodiment, the sum of the surface areas of the blank blood vessels corresponding to all the groove-shaped structures 1204 on the surface of the supporting portion 120 accounts for 0-80% of the surface area of the blood vessel with the target length. Here, 0 denotes that the surface of the support portion 120 is not provided with the distributed groove structure 1204; 80% means that each of the channel-shaped structures 1204 occupies 80% of the surface area of the support portion 120, i.e., at least 20% of the surface area is available to support the target lesion. The 20% area for supporting the target lesion blood vessel is set by referring to the metal coverage of a general stent, and particularly, the description about the metal coverage of the stent can be referred to in page 18 of the clinical application of the drug eluting stent. In this document, the authors believe that balloon-only expansion does not provide support to the vessel wall beyond the metallic stent, which has a metal coverage of up to 20%, so that at least 20% of the surface of the support 120 of the present invention is available to support the target vascular disorder for safety. If the area ratio of the balloon for supporting the blood vessel is too small, the balloon can not support the vascular lesion sufficiently, the postoperative vascular lesion is retracted highly, the loss rate of the lumen is high, and the operation effect is not good.

Furthermore, in the embodiment, the ratio of the sum of the surface areas of the blank blood vessels corresponding to all the groove-shaped structures 1204 distributed on the surface of the supporting portion 120 to the surface area of the blood vessel with the target length is 20% -50%, wherein 20% of the surface areas of the blood vessels with the groove-shaped structures 1204 distributed on the surface of the supporting portion 120 are ensured, and at least 20% of the damage of the balloon to the blood vessel wall is clinically significant, and if the sum is lower than 20%, the effect is not obvious; 50% be in order to further ensure the support effect of sacculus to the vascular wall, the unsettled area proportion of control blood vessel when, avoid large tracts of land vascular tissue and pathological change plaque directly to inlay in channel structure 1204 when the sacculus expands (unsettled area is big more, and the area that sacculus and vascular wall contacted is little less, then unsettled tissue and plaque owing to lack the support and fall the card into channel structure 1204 more easily). Once the blood vessel tissue and the lesion plaque are embedded into the groove-shaped structure 1204, on one hand, the inner surface of the lesion tissue consisting of the blood vessel wall and the plaque is raised and uneven, and even the lumen patency is insufficient and long-term thrombus is possibly caused; on the other hand, the embedded lesion tissues can invade the space for storing the nano liquid medicine in the groove-shaped structure 1204, so that the nano medicine content in the suspended vascular tissues is naturally reduced, the incidence rate of intimal hyperplasia and restenosis is increased due to the low-concentration tissue medicine content, and the long-term clinical effect is not facilitated.

EXAMPLE III

The present embodiment provides another drug balloon 100, which has a structure substantially similar to the drug balloon 100 in the second embodiment, and for the sake of simplicity, only the differences from the second embodiment will be described in the present embodiment.

As shown in fig. 13-15, in the present embodiment, a plurality of groove-shaped structures 1204 are distributed on the cylindrical surface between the distal edge 1201 and the proximal edge 1209 of the support portion 120, each groove-shaped structure 1204 is an annular groove extending along the circumferential direction of the support portion 120, and the plurality of annular grooves are arranged in an array along the axial direction of the support portion 120. Further, in the present embodiment, the plurality of annular grooves are not communicated with each other, that is, the liquid medicine stored in each of the groove structures 1204 is not communicated with each other. In this embodiment, the total area of each groove-shaped structure 1204 is equivalent to the total area of each protrusion structure 1202, so that the supporting effect of the drug balloon 100 on the vessel wall and the therapeutic effect of the liquid medicine in the groove on the vessel tissue are effectively balanced.

Example four

As shown in fig. 16 to 18, in the present embodiment, a plurality of groove-shaped structures 1204 are distributed on the cylindrical surface between the distal end edge 1201 and the proximal end edge 1209 of the support portion 120, each groove-shaped structure 1204 is an arc-shaped groove extending along the circumferential direction of the support portion 120, and the plurality of arc-shaped grooves are arranged in an axial array along the support portion 120, and an arc-shaped protrusion is formed between the axially adjacent arc-shaped grooves. Further, in the present embodiment, the plurality of arc-shaped slots are not communicated with each other, that is, the liquid medicine stored in each slot-shaped structure 1204 is not communicated with each other. In this embodiment, the supporting portion 120 further has a straight protrusion extending along the axial direction of the supporting portion 120, and the straight protrusion is sequentially connected to the arc-shaped grooves. The added straight strip-shaped protrusions can connect a plurality of arc-shaped protrusions arranged in an axial array along the supporting part 120 to form an integral protrusion structure which is mechanically associated with each other, so that collapse or inclination of a single arc-shaped protrusion when the single arc-shaped protrusion is subjected to a radially inward load of a vascular lesion plaque is avoided, and the supporting capability of the protrusion structure 1202 on the vascular lesion is improved. Further, the total area of the groove-shaped structures 1204 of the present embodiment is slightly smaller than the total area of the protrusion structures 1202. Therefore, on the basis of improving the treatment effect on the vascular tissue, the present embodiment also effectively increases the supporting effect of the drug balloon 100 on the vascular wall.

EXAMPLE five

As shown in fig. 19 to 21, in the present embodiment, a plurality of groove-shaped structures 1204 are distributed on the cylindrical surface between the distal end edge 1201 and the proximal end edge 1209 of the support portion 120, each groove-shaped structure 1204 is an arc-shaped groove extending along the circumferential direction of the support portion 120, and the plurality of arc-shaped grooves are arranged in an array along the axial direction and the circumferential direction of the support portion 120, and an arc-shaped protrusion is formed between the axially adjacent arc-shaped grooves. Illustratively, the present embodiment may distribute two rows of arc-shaped slots along the circumferential direction of the supporting portion 120, and each row of arc-shaped slots is uniformly arranged along the axial direction of the supporting portion 120. Further, in the present embodiment, the plurality of arc-shaped slots are not communicated with each other, that is, the liquid medicine stored in each slot-shaped structure 1204 is not communicated with each other. In this embodiment, the supporting portion 120 is further provided with two straight strip-shaped protrusions extending along the axial direction of the supporting portion 120. The two straight strip-shaped protrusions can further and stably connect the plurality of arc-shaped protrusions arranged in the axial array along the support portion 120 to form a stable integral protrusion structure which is mechanically related to each other, so that collapse or inclination of a single arc-shaped protrusion when the single arc-shaped protrusion is subjected to a radially inward load of a vascular lesion plaque is avoided, and the supporting capability of the protrusion structure 1202 on vascular lesions is improved. Preferably, the total area of each groove-shaped structure 1204 in this embodiment is smaller than that of each protrusion structure 1202, so that the supporting effect of the drug balloon 100 on the vessel wall is further increased on the basis of improving the treatment effect on the vessel tissue.

EXAMPLE six

As shown in fig. 22-24, in the present embodiment, a plurality of groove-shaped structures 1204 are distributed on the cylindrical surface between the distal edge 1201 and the proximal edge 1209 of the support 120, each groove-shaped structure 1204 is a rectangular groove, the length or width of each rectangular groove is parallel to the axial direction of the support 120, and the plurality of rectangular grooves are simultaneously arranged in an array along the axial direction and the circumferential direction of the support 120. Preferably, four rows of rectangular grooves are distributed along the circumferential direction of the support portion 120 in the present embodiment, and each row of rectangular grooves is uniformly distributed along the axial direction of the support portion 120. Further, in this embodiment, the plurality of rectangular grooves are not communicated with each other, that is, the liquid medicine stored in each groove-shaped structure 1204 is not communicated with each other. In this embodiment, a rectangular protrusion is formed between the axially adjacent rectangular grooves, and four straight-bar-shaped protrusions extending axially along the supporting portion 120 are further disposed on the supporting portion 120. The four straight strip-shaped protrusions can further stably connect the plurality of rectangular protrusions arranged in the axial array along the support portion 120 to form a stable integral protrusion structure which is mechanically associated with each other, so that collapse or inclination of a single rectangular protrusion when the single rectangular protrusion is subjected to a radially inward load of a vascular lesion plaque is avoided, and the supporting capability of the protrusion structure 1202 on the vascular lesion is improved. Further, the total area of each groove-shaped structure 1204 is significantly smaller than the total area of each protrusion structure 1202 in this embodiment, so that the supporting effect of the drug balloon 100 on the vessel wall is more effectively improved on the basis of improving the therapeutic effect on the vascular tissue.

Comparative example

Fig. 25 is an image of a prior art DSA contrast follow-up after implantation of a stent into a blood vessel. As shown in FIG. 25, after 180 days of stent implantation in the right coronary artery of a pig, the widths of 3 segments in the vessel were 2.9mm, 3.0mm and 2.9mm from top to bottom, respectively, the vessel diameter L1 at the proximal end of the lesion, the vessel diameter L2 at the middle section of the lesion and the vessel diameter L3 at the distal end of the lesion. In the animal experiment, due to the problem of equipment precision, the precision of the diameter result of the blood vessel measured by the DSA is 1 digit after the decimal point; in actual human clinical practice, the precision of the DSA equipment is higher, and the measured diameter value is usually 2 bits after the decimal point. The results show that the lumen diameters of the proximal and distal lesions are smaller than the middle lesion, i.e., the lumen loss is more pronounced at the proximal and distal lesions, and the restenosis is more pronounced, which reflects and verifies the above statement that the restenosis lesions at the proximal and distal regions are more severe than the middle lesion clinically.

Through intensive research and analysis, the inventor finds that the conditions of restenosis of blood vessels at two ends of an implanted area caused by balloon expansion are similar to stents, and are caused by damage to the blood vessels caused by mechanical expansion. After the traditional stent or the drug balloon is implanted, the proximal blank blood vessel and the distal blank blood vessel (namely, the blood vessel areas which are not applied with the drug) of the implanted section of the blood vessel of the instrument are mechanically damaged by force transmission from the balloon and the drug stent, but the blank blood vessel is lack of enough drug to resist the smooth muscle cell proliferation and the occurrence of restenosis, so that the blood vessel areas contacted with the two ends of the balloon are more easily subjected to restenosis lesion, and the stenosis degree is more serious.

It is to be noted that the foregoing is only illustrative of the preferred embodiments of the present invention and the technical principles employed. It will be understood by those skilled in the art that the present invention is not limited to the particular embodiments described herein, but is capable of various obvious changes, rearrangements and substitutions as will now become apparent to those skilled in the art without departing from the scope of the invention. Therefore, although the present invention has been described in greater detail by the above embodiments, the present invention is not limited to the above embodiments, and may include other equivalent embodiments without departing from the spirit of the present invention, and the scope of the present invention is determined by the scope of the appended claims.

Claims

1. The utility model provides a medicine balloon, includes distal end pyramis, supporting part and the proximal end pyramis that sets gradually, its characterized in that:

2. The drug balloon according to claim 1, wherein the maximum diameter of the first tapered portion is greater than or equal to the inner diameter of a control blood vessel and less than or equal to the maximum outer diameter of the support portion, and the first flow channel is in contact with the inner wall of the control blood vessel in the circumferential direction only through the maximum diameter edge of the first tapered portion; and/or

3. The drug balloon of claim 1, wherein the first flow channel has an open-topped arcuate trajectory in a cross section along an axial direction of the drug balloon, the arcuate trajectory starting from the distal edge of the support portion and ending at a maximum diameter edge of the first taper portion, and a tangent to a starting point of the arcuate trajectory makes an angle σ 1 with a vertical, 0 ° ≦ σ 1 < 90 °, and a tangent to an ending point of the arcuate trajectory makes an angle σ 2 with a vertical, 0 ° ≦ σ 2 < 90 °; and/or

4. The drug balloon of claim 1, wherein the first flow channel is internally provided with at least one of the micropores, and/or

At least one micropore is arranged in the second flow passage.

5. The drug balloon of claim 1, wherein at least one groove-shaped structure is distributed on the cylindrical surface between the distal end edge and the proximal end edge of the supporting portion, and at least one groove-shaped structure is arranged in an array along the axial direction and/or the circumferential direction of the supporting portion.

6. The drug balloon of claim 5, wherein the groove-shaped structure is an annular groove extending in the circumferential direction of the support portion, or an arc-shaped groove extending in the circumferential direction of the support portion, or a long straight groove extending in the axial direction of the support portion, or a rectangular groove parallel to the axial direction of the support portion; the groove-shaped structures are mutually communicated or not communicated.

7. The drug balloon of claim 5, wherein the micro-holes open on the surface of the raised structures between the groove-shaped structures of the support portion and/or the micro-holes open within the groove-shaped structures of the support portion.

8. The drug balloon according to claim 5, wherein the sum of the surface areas of the empty blood vessels corresponding to the groove-shaped structures on the surface of the supporting portion accounts for 0-80% of the surface area of the blood vessel with the target length.

9. The drug balloon of claim 5, wherein the surfaces of the support portions near the distal and proximal edges are circular protrusions.

10. A drug balloon according to any of claims 1-9, wherein the furthest end point of the contour of a column of the micro holes closest to the distal edge of the support is at a distance of 0.001-1.0mm from the distal edge of the support; and/or