Drug delivery balloon

Abstract

This invention discloses a drug delivery balloon, comprising: a balloon body having a radially deformable region thereon, wherein a radially concave portion is formed in the radially deformable region when the balloon body is in a contracted state, and an accommodating space is formed within the radially concave portion; a guidewire axially passing through the balloon body; and a rupture component disposed within the accommodating space; the rupture component includes a radially outwardly invasive portion and a base portion located radially inwardly on the invasive portion, the bottom of the base portion and the outer wall of the balloon wall defining a sheet-like cavity, and a drug delivery channel extending through the sheet-like cavity is formed in the invasive portion; a first fluid channel and a second fluid channel are constructed within the guidewire, the second fluid channel extending to the proximal end of the balloon body and forming a second fluid outlet; and a drug delivery channel is established between the second fluid outlet and the sheet-like cavity, the drug delivery channel being formed on the balloon wall of the balloon body for delivering drug flowing from the second fluid outlet to the sheet-like cavity.

Description

Technical Field

[0001] This invention relates to the field of medical device technology, and in particular to a drug delivery balloon for use in angioplasty. Background Technology

[0002] Myocardial infarction and stroke caused by atherosclerosis are occurring more and more frequently. A typical feature of atherosclerosis is the formation of plaques inside blood vessels, which narrows the inner diameter of the blood vessels (stenosis), thus forming diseased segments. These narrowed diseased segments may be blocked by free thrombi, leading to sudden myocardial infarction or stroke.

[0003] Angioplasty aims to dilate narrowed blood vessels to increase the diameter of the pores, thereby significantly reducing the probability of the blood vessel being blocked by free thrombi, and thus effectively reducing the risk of myocardial infarction or stroke.

[0004] As a core component of angioplasty, the balloon, after being delivered to the diseased segment, applies mechanical force to the plaque within the diseased vessel through inflation to perform transient dilation of the diseased segment. This can be used as a final dilation treatment for the diseased segment (i.e., only transient dilation of the diseased segment) or, in conjunction with a stent, as a basic dilation treatment for the diseased segment (i.e., after transient dilation of the diseased segment using a balloon, permanent dilation of the diseased segment is then performed using a stent).

[0005] One characteristic of old plaques is that their surface calcification is thick and hard. When dilating lesion segments with old plaques, the mechanical force provided by the balloon is sometimes insufficient to dilate the lesion segment or to dilate it to the expected extent, resulting in balloon dilation failure or failure to achieve the expected dilation effect.

[0006] To effectively dilate diseased segments with old plaques, the prior art provides a balloon (for example, the applicant's earlier patent application number 202310151107.5, entitled "Perforated Balloon"). The balloon is characterized by having a perforation component arranged on the balloon body. During the balloon body's inflation process, the perforation component invades the plaque, thereby effectively reducing the overall hardness of the plaque within the diseased segment, thus enabling the balloon to effectively dilate diseased segments with old plaques.

[0007] However, during and / or after balloon dilation of the diseased segment, the diseased segment may experience endothelial tearing and tissue bleeding due to dilation, which can easily lead to vascular rupture and aortic dissection.

[0008] To reduce the risk of vascular rupture and inhibit vascular dissection, a balloon is provided in the prior art. The balloon is characterized by carrying a drug for tissue repair (such as paclitaxel or rapamycin, drugs used to inhibit cell proliferation) in the ruptured component. When the ruptured component invades the plaque, the drug is released into the diseased segment along with the invasion of the ruptured component to repair endothelial tears and tissue bleeding, thereby reducing the risk of vascular rupture and effectively inhibiting vascular dissection.

[0009] The balloons provided in the prior art carry drugs in the following ways: the drug is coated on the surface of the rupture component, or grooves or blind holes are constructed on the surface of the rupture component, and the drug is filled into the grooves or blind holes.

[0010] However, this type of balloon for drug delivery has the following drawbacks in angioplasty:

[0011] 1. During the process of the balloon switching from the constricted state to the inflated state, and before penetrating into the plaque, some of the drug is uncontrollably released into the bloodstream, resulting in drug loss and thus insufficient drug delivery to the plaque.

[0012] 2. The amount of drug that the ruptured component can hold is relatively small, resulting in insufficient drug delivery to the plaque.

[0013] 3. In the early stages of plaque invasion through the ruptured component, the drug may be released rapidly and uncontrollably, thus preventing the drug from being released continuously throughout the angioplasty procedure.

[0014] 4. Because liquid drugs have high fluidity, broken parts are not suitable for carrying liquid drugs.

[0015] Although existing technologies provide a way to deliver drugs to the balloon's perforation component at the proximal end of the catheter (the end away from the balloon) to address the issues of insufficient drug dosage and continuous drug delivery, this method requires constructing a two-layer balloon body with an inner and outer layer at the balloon site. This structure makes the balloon very difficult to manufacture, and the mechanical force exerted by the balloon on the blood vessel will fluctuate significantly during the drug delivery process. Summary of the Invention

[0016] To address the aforementioned technical problems in the prior art, embodiments of the present invention provide a drug delivery balloon.

[0017] To solve the above-mentioned technical problems, the technical solution adopted in the embodiments of the present invention is as follows:

[0018] A drug delivery balloon, comprising:

[0019] The balloon body has an inflated state and a contracted state. An axially extending radial deformation region is constructed on the balloon body. When the balloon body is in the contracted state, the radial deformation region is in a radially inward contracted state to form a radially constricted portion. The radially constricted portion has an axially extending accommodating space and a constricted opening located radially outward of the accommodating space.

[0020] A guidewire is axially inserted through the balloon body, and both ends of the balloon body are fixedly covered by the guidewire.

[0021] A breaking component is disposed within the accommodating space;

[0022] The perforation component includes an outwardly invasive portion and a base portion located radially inwardly to the invasive portion. The bottom of the base portion is attached to and fixed to the outer wall of the balloon body and defines a sheet-like cavity with the outer wall of the balloon body. A drug delivery channel penetrating the sheet-like cavity is provided in the invasive portion.

[0023] The guidewire contains a first fluid conduit and a second fluid conduit. The first fluid conduit extends to the axial segment corresponding to the balloon body and forms a first fluid outlet. Pressurized fluid is supplied to the interior of the balloon body through the first fluid outlet, causing the balloon body to inflate. The second fluid conduit extends to the proximal end of the balloon body and forms a second fluid outlet. Wherein:

[0024] A drug delivery channel is established between the second fluid outlet and the sheet cavity. The drug delivery channel is formed on the wall of the balloon body to deliver the drug flowing from the second fluid outlet to the sheet cavity and out of the invasive portion through the drug delivery channel.

[0025] Preferably, the drug delivery balloon further includes a first membrane, the first membrane being configured in a strip shape, the first membrane covering the outer wall of the balloon body; wherein:

[0026] The two sides of the first membrane in the width direction are bonded and fixed to the outer wall of the capsule wall so that the first membrane and the capsule wall define the drug delivery channel;

[0027] The first membrane extends axially along the balloon body and corresponds to the circumferential position of the rupture component, such that the balloon wall at the circumferential position corresponding to the rupture component forms the drug delivery channel, thereby allowing the distal end of the drug delivery channel to enter the sheet-like cavity axially.

[0028] Preferably, the perforation components include a plurality of circumferentially arranged components, each of which corresponds to the drug delivery channel; wherein:

[0029] The drug delivery balloon further includes a second membrane, which surrounds the proximal end of the balloon body circumferentially and forms an annular flow channel with the balloon wall at the proximal end of the balloon body; the proximal end of the drug delivery channel extends into the annular flow channel, and the second fluid outlet extends into the annular flow channel.

[0030] Preferably,

[0031] Each of the aforementioned breaching components is divided into multiple segments arranged sequentially along the axial direction;

[0032] Each of the first membranes is bonded to the capsule wall at its center in the width direction, dividing the drug delivery channels into multiple parallel channels. By constructing stepped notches on the first membranes corresponding to the multiple rupture components, the multiple drug delivery channels extend into the sheet-like cavity enclosed by the multiple rupture components.

[0033] Preferably, the cross-sectional structure of the first membrane is configured such that an arch is formed in the middle, the arch and the capsule wall defining the drug delivery channel.

[0034] Preferably, the thickness of both the first membrane and the second membrane is less than the thickness of the balloon wall of the balloon body.

[0035] Preferably, a rectangular ring is attached and fixed to the outer wall of the capsule wall corresponding to the rupture component, the base of the rupture component is fixed to the rectangular ring, and the rectangular ring, the bottom of the base, and the capsule wall define the sheet-like cavity; the drug delivery channel extends to the bottom of the base and communicates with the sheet-like cavity; a clearance groove is provided at the bottom of the rectangular ring, and the first membrane enters the sheet-like cavity through the clearance groove.

[0036] Preferably, the bottom of the base is covered with a throttling membrane, and the throttling membrane has a plurality of throttling holes corresponding one-to-one with the drug delivery channels. The drug in the plate-shaped cavity enters the drug delivery channels through the throttling holes.

[0037] Preferably, the invasive portion includes a plurality of protruding needles integrally formed with the base portion, and the drug delivery channel passes through the protruding needles; wherein:

[0038] The cross-section of the protruding pin is prismatic; a slit is formed from the top of the protruding pin downwards.

[0039] Preferably, the invasive portion is a cutting edge with a triangular cross-section, and the upper end of the drug delivery channel penetrates the two inclined surfaces of the cutting edge.

[0040] Compared with the prior art, the beneficial effects of the drug delivery balloon provided by the embodiments of the present invention are:

[0041] By establishing drug delivery channels on the balloon wall of the balloon body, creating drug delivery orifices inside the rupture component, and establishing a sheet-like cavity between the rupture component and the balloon wall of the balloon body, it is possible to deliver drugs in vitro and continuously and adequately into the plaque via the balloon of the present invention. Furthermore, since the drug delivery channels are formed on the balloon wall of the balloon body, the drug delivery process has less impact on the mechanical force applied by the balloon body to the lesion segment, resulting in less pressure fluctuation of the mechanical force.

[0042] Other key advantages of the present invention are described directly and implicitly in the detailed embodiments described below.

[0043] The overview of various implementations or examples of the technology described in this invention is not a complete disclosure of the full scope or all features of the disclosed technology. Attached Figure Description

[0044] Figure 1 A front view of a drug delivery balloon provided for an embodiment of the present invention.

[0045] Figure 2 for Figure 1 A magnified view of part A.

[0046] Figure 3 for Figure 1 BB-direction sectional view.

[0047] Figure 4 A cross-sectional view of a drug delivery balloon with an invasive portion of a first structural form installed in a contracted state, provided as an embodiment of the present invention.

[0048] Figure 5 A cross-sectional view of a drug delivery balloon with an invasive portion of a first structural form installed in an inflated state, provided as an embodiment of the present invention.

[0049] Figure 6 for Figure 5 A magnified view of part C.

[0050] Figure 7 A three-dimensional structural diagram of the breach component with the first structural form of the intrusion section.

[0051] Figure 8 for Figure 7 A magnified view of part D.

[0052] Figure 9 This is a three-dimensional structural diagram of the breach component with the first structural form of the intrusion section, from another perspective.

[0053] Figure 10A cross-sectional view of a drug delivery balloon with an invasive portion of a second structural form installed in a contracted state, provided as an embodiment of the present invention.

[0054] Figure 11 A cross-sectional view of a drug delivery balloon with an invasive portion of a second structural form installed, provided as an embodiment of the present invention, in an inflated state.

[0055] Figure 12 for Figure 11 A magnified view of part E.

[0056] Figure 13 This is a three-dimensional structural diagram of a breach component with a second structural form.

[0057] In the picture:

[0058] 10-Balloon body; 11-Balloon wall; 111-Outer wall; 12-Radial deformation region; 121-Accommodation space; 122-Constriction; 123-Radially inward constriction; 13-Radially outward protrusion; 20-Guidewire; 21-First fluid conduit; 211-First fluid outlet; 22-Second fluid conduit; 221-Second fluid outlet; 30-Break-in component; 31-Invasion section; 311-Protruding needle; 311 1-Gap; 32-Base section; 33-Drug delivery channel; 34-Sheet-shaped cavity; 35-Rectangular ring; 351-Allowing groove; 36-Throttle membrane; 361-Throttle orifice; 40-Drug delivery channel; 41-First membrane; 411-Arch; 312-Edge; 3121-Bevel; 42-Stepped notch; 50-Annular guide cavity; 51-Second membrane; 100-Lesion segment; 101-Plaque. Detailed Implementation

[0059] Unless otherwise defined, the technical or scientific terms used in this invention shall have the ordinary meaning understood by one of ordinary skill in the art to which this invention pertains. The terms "first," "second," and similar terms used in this invention do not indicate any order, quantity, or importance, but are merely used to distinguish different components. Terms such as "comprising" or "including" mean that the element or object preceding the word encompasses the elements or objects listed following the word and their equivalents, without excluding other elements or objects. Terms such as "connected" or "linked" are not limited to physical or mechanical connections, but can include electrical connections, whether direct or indirect. Terms such as "upper," "lower," "left," and "right" are used only to indicate relative positional relationships; when the absolute position of the described object changes, the relative positional relationship may also change accordingly.

[0060] To keep the following description of the embodiments of the present invention clear and concise, detailed descriptions of known functions and known components are omitted.

[0061] This invention discloses a drug delivery balloon that, while creating a rupture in the plaque within a diseased vessel segment to dilate the segment, simultaneously releases medication into the plaque to repair the rupture and reduce vascular damage caused by dilation (e.g., endothelial tearing, tissue bleeding), thereby reducing the risk of vascular rupture and effectively inhibiting aortic dissection. This drug delivery balloon is particularly suitable for dilating diseased segments with old plaques, and especially for dilating diseased segments in the aorta (e.g., the carotid artery). The balloon can be used alone for transient dilation of the diseased segment; it can also be used in conjunction with a stent, i.e., after transient dilation of the diseased segment using the balloon, a stent is used to permanently support (dilate) the segment.

[0062] like Figure 1 As shown, the drug delivery balloon includes a balloon body 10, a guidewire 20, and multiple perforation components 30.

[0063] The balloon body 10 includes a main body region located in the middle and conical regions located on both sides of the main body region. The outer sides of the two conical regions are the proximal and distal ends of the balloon body 10, respectively. Figure 1 The left end shown is the proximal end of the balloon body 10, and the right end is the distal end of the balloon body 10. The guidewire 20 is used to insert the balloon body 10 along the lumen of the blood vessel into the lesion segment 100. The guidewire 20 axially passes through the proximal and distal ends of the balloon body 10. The balloon walls 11 at both the proximal and distal ends of the balloon body 10 are covered by the guidewire 20 using adhesive bonding, heat fusion bonding, or other methods. The balloon body 10 is manufactured using an elastic material such as polyamide through injection molding, thus giving it elastic deformation capability; for example... Figure 1 and combined Figure 3 As shown, the guidewire 20 has a hollow internal structure, forming a first fluid conduit 21 within it. This first fluid conduit 21 extends at least to a axial segment corresponding to the balloon body 10, and a first fluid outlet 211 radially penetrating the first fluid conduit 21 is provided on this axial segment. Thus, by supplying pressurized fluid (e.g., liquid, specifically physiological saline or contrast agent) to the proximal end of the guidewire 20 (the end located outside the body), the pressurized fluid travels along the first fluid conduit 21 and enters the interior of the balloon body 10 outside the guidewire 20 through the first fluid outlet 211, thereby forcing the balloon body 10 to inflate. The balloon body 10 can be elastically restored and contracted by removing the fluid from its interior. Therefore, the balloon body 10 has a controllable inflation and contraction state. Figure 4As shown, when it is necessary to deliver the balloon body 10 to the lesion segment 100, the balloon body 10 is in a contracted state to facilitate the passage of the balloon body 10 through the lesion segment 100; as Figure 5 As shown, after the balloon body 10 passes through the lesion segment 100, the balloon body 10 is switched from a contracted state to an inflated state by providing pressurized fluid to the balloon body 10, so as to expand the lesion segment 100.

[0064] Multiple axially extending and circumferentially arranged radial deformation regions 12 are constructed on the balloon body 10, and the deformation characteristics of each radial deformation region 12 are configured as follows: Figure 1 and Figure 4 As shown, when the balloon body 10 is in a contracted state, the radial deformation region 12 contracts radially inward, thereby forming a radially constricted portion 123 surrounded by the balloon wall 11 of the balloon body 10 in the region. The radially constricted portion 123 is located inside the outer periphery enclosed by the balloon body 10 in the contracted state. Furthermore, an accommodating space 121 is formed inside the radially constricted portion 123, which extends in the same direction as the radially constricted portion 123. The radially constricted portion 123 also forms a constricted opening 122 located radially outside the accommodating space 121, with a cross-sectional width corresponding to the accommodating space 121 that is smaller than that of the accommodating space 121.

[0065] like Figure 4 and Figure 10 As shown, each radially constricted portion 123 has a rupture component 30 in its accommodating space 121. This rupture component 30 is elongated and arranged along the axial direction of the balloon body 10, thus aligning with the extending direction of the accommodating space 121. The rupture component 30 includes a radially outwardly facing intrusion portion 31 and a base portion 32 located radially inwardly to the intrusion portion 31. The bottom of the base portion 32 is directly or indirectly attached to the outer wall 111 of the balloon body 10 wall 11 corresponding to the accommodating space 121, thereby fixing the rupture component 30 to the balloon body 10. When the balloon body 10 is in a contracted state, as... Figure 2 and Figure 4 as well as Figure 10 As shown, the rupture component 30 is located within the accommodating space 121 of the radially recessed portion 123 and does not protrude beyond the outer periphery enclosed by the balloon body 10. Therefore, during the delivery of the balloon body 10 to the lesion segment 100, the intrusion portion 31 of the rupture component 30, being located inside the balloon body 10, reduces the probability of scratching the vessel walls of normal blood vessels near both sides of the lesion segment 100. Furthermore, when the balloon body 10 is switched to an inflated state using pressurized fluid, such as... Figure 5 and Figure 11As shown, the radially constricted portion 123 drives the rupture component 30 to move radially outward and protrude radially outside the balloon body 10 through the expanded constriction 122. Simultaneously, the intrusion portion 31 of the rupture component 30 enters the plaque 101, thereby effectively reducing the overall hardness of the plaque 101 within the lesion segment 100 and achieving effective expansion of the lesion segment 100 by the balloon body 10. In some more preferred structures, such as... Figure 1 As shown, the radial deformation region 12 is confined within the main body region of the balloon body 10. Thus, when the balloon body 10 is in a contracted state, the constriction 122 can be effectively maintained at a small opening, thereby effectively preventing the intrusion portion 31 of the rupture component 30 from protruding outside the balloon body 10 due to the easy opening of the constriction 122 in the contracted state, thus effectively reducing the probability of the intrusion portion 31 scratching the blood vessel wall. After the balloon body 10 inflates, the radially constricted portion 123 forms a radially outward protrusion 13 by protruding radially outward. This radially outward protrusion 13 protrudes beyond the outer periphery enclosed by the balloon body 10, further increasing the radial protrusion of the rupture component 30 beyond the balloon body 10. Figure 5 As shown, after the balloon body 10 inflates and the rupture component 30 invades the plaque 101, the balloon wall 11 of the balloon body 10 will not come into contact with the inner wall of the plaque 101, thereby reducing the direct compression on the plaque 101.

[0066] The key structural features of the balloon provided by this invention are as follows.

[0067] First aspect:

[0068] like Figure 1 , 2 As shown in Figure 6, a sheet-like cavity 34 is defined between the bottom of the base portion 32 of the rupture component 30 and the outer wall 111 of the bladder wall 11 corresponding to the accommodating space 121. Furthermore, a plurality of drug delivery channels 33 are provided from the surface of the intrusion portion 31 of the rupture component 30 toward the bottom of the base portion 32, and the drug delivery channels 33 extend into the sheet-like cavity 34.

[0069] The second aspect:

[0070] like Figure 1 and Figure 3 As shown, a second fluid conduit 22 is also constructed inside the guidewire 20. The second fluid conduit 22 extends from the proximal end of the guidewire 20 to the axial segment corresponding to the proximal end of the balloon body 10, and a second fluid outlet 221 is provided on the axial segment that radially extends to the second fluid conduit 22. The second fluid conduit 22 is used to deliver drugs, that is, drugs can be delivered from the proximal end of the guidewire 20 to the balloon body 10 through the second fluid conduit 22.

[0071] Third aspect:

[0072] like Figure 1 and Figure 6 As shown, a drug delivery channel 40 is established between the second fluid outlet 221 and the corresponding sheet cavity 34 of each circumferentially arranged perforated component 30 so that the second fluid outlet 221 is connected to each sheet cavity 34 through the corresponding drug delivery channel 40; and the drug delivery channel 40 is formed outside the outer wall 111 of the capsule wall 11.

[0073] Based on the above-mentioned structural features of the balloon, during the process of the balloon body 10 inflating and causing the intrusion portion 31 of the rupture component 30 to invade the plaque 101 or after intrusion into the interior of the plaque 101, the second fluid conduit 22 can be used to provide drugs. Furthermore, the drugs are delivered through the drug delivery channel 40 to the corresponding lamellae 34 of each rupture component 30. The drugs entering the lamellae 34 are released into the interior of the plaque 101 through a plurality of drug delivery channels 33 to repair the damage to the related tissues of the lesion segment 100 caused by the rupture and expansion.

[0074] By establishing a drug delivery channel 40 on the balloon wall 11 of the balloon body 10, creating a drug delivery channel 33 inside the rupture component 30, and establishing a sheet-like cavity 34 between the rupture component 30 and the balloon wall 11 of the balloon body 10, it is possible to deliver drugs in vitro and continuously and adequately into the plaque 101 via the balloon of the present invention. Furthermore, since the drug delivery channel 40 is formed on the balloon wall 11 of the balloon body 10, the drug delivery process has less impact on the mechanical force applied by the balloon body 10 to the lesion segment 100, resulting in less pressure fluctuation of the mechanical force.

[0075] The present invention also provides a preferred method and structure for establishing a drug delivery channel 40, namely, establishing the drug delivery channel 40 by attaching a membrane (first membrane 41) to the outer wall 111 of the balloon body 10. Specifically, as Figure 1 , 2As shown in Figure 6, the first diaphragm 41 is cut into a strip shape and arranged along the axial direction of the balloon body 10, located between the sheet-like cavity 34 corresponding to each rupture component 30 and the second fluid outlet 221. The two sides of the first diaphragm 41 in the width direction are bonded to the outer wall 111 of the balloon body 10 via adhesive, heat fusion, or other methods. Thus, a linear flow channel for fluid passage, i.e., a drug delivery channel 40, is defined between the middle of the first diaphragm 41 and the outer wall 111 of the balloon body 10. This method of establishing the drug delivery channel 40 by attaching a diaphragm to the outer wall 111 of the balloon body 10 greatly reduces the difficulty of establishing the drug delivery channel 40. Furthermore, since the drug delivery channel 40 is located on the outside of the balloon body 10, the drug delivery process has little impact on the inflation state of the balloon body 10. In some more preferred configurations, the first membrane 41 is made of the same material as the balloon body 10, and the thickness of the first membrane 41 is much smaller than the thickness of the balloon wall 11 of the balloon body 10. In this way, the first membrane 41 deforms before the balloon body 10 in response to the pressure of the delivered drug, thereby further reducing the influence of the drug delivery process on the inflation state of the balloon body 10.

[0076] In some more preferred embodiments, such as Figure 6 As shown, the cross-sectional structure of the first membrane 41 is configured such that an arch 411 is formed in the middle, and the arch 411 and the capsule wall 11 define a drug delivery channel 40. In this way, the drug delivery channel 40 has sufficient flow cross-sectional margin, so that even if the cross-section of the drug delivery channel 40 is reduced due to the deformation of the balloon body 10, the drug delivery channel 40 can still provide a sufficient flow of drug to the sheet cavity 34.

[0077] In some more preferred embodiments, such as Figure 1 , 3 As shown in Figures 4 and 6, the first diaphragm 41 corresponds circumferentially to each rupture component 30. Thus, the first diaphragm 41 and the circumferentially oriented capsule wall 11 corresponding to the rupture component 30 form a drug delivery channel 40, with the distal end of the drug delivery channel 40 axially entering the sheet-like cavity 34. The advantage of this arrangement is that during the inflation of the balloon body 10, the capsule wall 11 corresponding to the rupture component 30 deforms very little due to the constraint of the rupture component 30. Consequently, the deformation of the first diaphragm 41 corresponding to the capsule wall 11 in that region is small. Therefore, the inflation process of the balloon body 10 has a smaller impact on the flow cross-section of the drug delivery channel 40 formed by the first diaphragm 41 and the outer wall 111 of the capsule wall 11 in that region.

[0078] In some more preferred embodiments, such as Figure 1 and Figure 3As shown, a second membrane 51 is disposed on the proximal end of the balloon body 10 at an axial position corresponding to the second fluid outlet 221. The second membrane 51 is circumferentially surrounding the proximal end of the balloon body 10. The second membrane 51 is attached in a similar manner to the first membrane 41, that is, the two sides of the second membrane 51 in the width direction are bonded and fixed to the outer wall 111 of the balloon wall 11 at the proximal end of the balloon body 10, so that the middle part of the second membrane 51 and the outer end of the proximal balloon wall 11 define an annular flow channel 50. The proximal end of the circumferentially arranged and axially extended first membrane 41 is connected to the second membrane 51, so that the proximal end of the drug delivery channel 40 defined by the first membrane 41 extends into the annular flow channel 50. In this way, the drug flowing out from the second fluid outlet 221 first enters the annular flow channel 50 and then enters each drug delivery channel 40. Thus, the drug can be more evenly distributed to each drug delivery channel 40 through the annular flow channel 50. In some preferred configurations, the second membrane 51 is made of the same material as the balloon body 10, and the thickness of the second membrane 51 is much smaller than the thickness of the balloon wall 11 of the balloon body 10.

[0079] In some more preferred embodiments, such as Figure 1 and combined Figure 6 As shown, each rupture component 30 located in the accommodating space 121 is divided into multiple segments, and the multiple rupture components 30 are arranged sequentially at intervals along the axial direction. This helps to improve the axial compliance of the balloon body 10, thereby enabling the balloon body 10 to penetrate blood vessels with tortuous characteristics. In these embodiments, the base 32 of each rupture component 30 located in the same accommodating space 121 defines a sheet-like cavity 34 with the outer wall 111 of the balloon body 10. Each first membrane 41 divides the drug delivery channel 40 into multiple parallel channels with the same number of segments as the rupture components 30 by bonding the middle portion of its width direction to the balloon wall 11. By constructing stepped notches 42 on the first membranes 41 corresponding to the multiple rupture components 30, the multiple drug delivery channels 40 respectively extend into the sheet-like cavity 34 formed by the multiple rupture components 30, and the drug in each drug delivery channel 40 flows into the corresponding sheet-like cavity 34 through the stepped notches 42. In these embodiments, multiple drug delivery channels 40 are constructed using a single membrane to accommodate the arrangement of the multiple rupture components 30.

[0080] In some more preferred embodiments, such as Figure 6 and Figure 7As shown, a rectangular ring 35 is attached and fixed to the outer wall 111 of the capsule wall 11 corresponding to the rupture component 30. The base 32 of the rupture component 30 is fixed to the rectangular ring 35. The rectangular ring 35, the bottom of the base 32, and the capsule wall 11 define a sheet-like cavity 34. The drug delivery channel 33 extends to the bottom of the base 32 and communicates with the sheet-like cavity 34. A clearance groove 351 is provided at the bottom of the rectangular ring 35, through which the first membrane 41 enters the sheet-like cavity 34. The rectangular ring 35 can be made of the same material as the capsule body 10. Therefore, the rectangular ring 35 has elastic deformation characteristics and flexibility. The rectangular ring 35 makes the rupture component 30 and the capsule wall 11 have better fit, thereby effectively preventing the rupture component 30 from separating from or cracking the capsule wall 11 due to deformation of the capsule wall 11.

[0081] In some more preferred embodiments, such as Figure 6 As shown, the bottom of the base 32 is covered with a throttling membrane 36, which has multiple throttling orifices 361 corresponding to the drug delivery channels 33. The drug in the plaque cavity 34 enters the drug delivery channel 33 through the throttling orifices 361. The throttling membrane 36 and the throttling orifices 361 are used to establish a certain pressure in the plaque cavity 34 and the upstream drug delivery channel 40, and to control the flow rate of the drug into the plaque 101 by throttling the drug.

[0082] Embodiments of the present invention also provide two structural forms of the intrusion portion 31 of the breaching component 30.

[0083] like Figures 6 to 9 As shown, the first structural form of the intrusion section 31 includes a plurality of rectangularly arranged protruding needles 311. The aforementioned drug delivery channel penetrates through these protruding needles, thereby forming a needle hole in the protruding needle. Furthermore, the cross-sectional shape of the protruding needle is constructed into a prismatic shape, which facilitates the needle hole's penetration into the plaque 101. A slit 3111 is formed downwards from the top of the protruding needle 311, allowing the intrusion section 31 to release drug at any depth in the invasion direction. The protruding needles 311 in this structural form can be laser-engraved. A balloon equipped with the perforation component 30 of this structure is more suitable for transient dilation of the diseased segment 100.

[0084] The second type of intrusive part 31: such as Figure 12 and Figure 13 As shown, the intrusion portion 31 is a triangular-shaped cutting edge 312, and the upper end of the drug delivery channel 33 passes through the two inclined surfaces 3121 of the cutting edge 312. This cutting edge 312 is used to cut the plaque 101 of the diseased segment 100. Therefore, the balloon with the rupture component 30 of this structure is more suitable for use in conjunction with a stent.

[0085] The above embodiments are merely exemplary embodiments of the present invention and are not intended to limit the present invention. The scope of protection of the present invention is defined by the claims. Those skilled in the art can make various modifications or equivalent substitutions to the present invention within its spirit and scope of protection, and such modifications or equivalent substitutions should also be considered to fall within the scope of protection of the present invention.

Claims

1. A drug delivery balloon, comprising: The balloon body has an inflated state and a contracted state. An axially extending radial deformation region is constructed on the balloon body. When the balloon body is in the contracted state, the radial deformation region is in a radially inward contracted state to form a radially constricted portion. The radially constricted portion has an axially extending accommodating space and a constricted opening located radially outward of the accommodating space. A guidewire is axially inserted through the balloon body, and both ends of the balloon body are fixedly covered by the guidewire. A breaking component is disposed within the accommodating space; Its features are, The perforation component includes an outwardly invasive portion and a base portion located radially inwardly to the invasive portion. The bottom of the base portion is attached to and fixed to the outer wall of the balloon body and defines a sheet-like cavity with the outer wall of the balloon body. A drug delivery channel penetrating the sheet-like cavity is provided in the invasive portion. The guidewire contains a first fluid conduit and a second fluid conduit. The first fluid conduit extends to the axial segment corresponding to the balloon body and forms a first fluid outlet. Pressurized fluid is supplied to the interior of the balloon body through the first fluid outlet, causing the balloon body to inflate. The second fluid conduit extends to the proximal end of the balloon body and forms a second fluid outlet. Wherein: A drug delivery channel is established between the second fluid outlet and the sheet cavity. The drug delivery channel is formed on the wall of the balloon body to deliver the drug flowing from the second fluid outlet to the sheet cavity and out of the invasive portion through the drug delivery channel.

2. The drug delivery balloon according to claim 1, characterized in that, The drug delivery balloon further includes a first membrane, the first membrane being configured in a strip shape, the first membrane covering the outer wall of the balloon body; wherein: The two sides of the first membrane in the width direction are bonded and fixed to the outer wall of the capsule wall so that the first membrane and the capsule wall define the drug delivery channel; The first membrane extends axially along the balloon body and corresponds to the circumferential position of the rupture component, such that the balloon wall at the circumferential position corresponding to the rupture component forms the drug delivery channel, thereby allowing the distal end of the drug delivery channel to enter the sheet-like cavity axially.

3. The drug delivery balloon according to claim 2, characterized in that, The breaching components include multiple components arranged circumferentially, each of which corresponds to the drug delivery channel; wherein: The drug delivery balloon further includes a second membrane, which surrounds the proximal end of the balloon body circumferentially and forms an annular flow channel with the balloon wall at the proximal end of the balloon body; the proximal end of the drug delivery channel extends into the annular flow channel, and the second fluid outlet extends into the annular flow channel.

4. The drug delivery balloon according to claim 2, characterized in that, Each of the aforementioned breaching components is divided into multiple segments arranged sequentially along the axial direction; Each of the first membranes is bonded to the capsule wall at its center in the width direction, dividing the drug delivery channels into multiple parallel channels. By constructing stepped notches on the first membranes corresponding to the multiple rupture components, the multiple drug delivery channels extend into the sheet-like cavity enclosed by the multiple rupture components.

5. The drug delivery balloon according to claim 2, characterized in that, The cross-sectional structure of the first membrane is configured such that an arch is formed in the middle, and the arch and the capsule wall define the drug delivery channel.

6. The drug delivery balloon according to claim 3, characterized in that, The thickness of both the first membrane and the second membrane is less than the thickness of the balloon wall of the balloon body.

7. The drug delivery balloon according to claim 2, characterized in that, A rectangular ring is attached and fixed to the outer wall of the capsule corresponding to the rupture component. The base of the rupture component is fixed to the rectangular ring. The rectangular ring, the bottom of the base, and the capsule wall define the sheet-like cavity. The drug delivery channel extends to the bottom of the base and communicates with the sheet-like cavity. An avoidance groove is provided at the bottom of the rectangular ring, and the first membrane enters the sheet-like cavity through the avoidance groove.

8. The drug delivery balloon according to claim 1, characterized in that, The bottom of the base is covered with a throttling membrane, and the throttling membrane has a plurality of throttling holes that correspond one-to-one with the drug delivery channels. The drug in the plate-shaped cavity enters the drug delivery channels through the throttling holes.

9. The drug delivery balloon according to claim 1, characterized in that, The invasive portion includes a plurality of protruding needles integrally formed with the base portion, and the drug delivery channel passes through the protruding needles; wherein: The cross-section of the protruding pin is prismatic; a slit is formed from the top of the protruding pin downwards.

10. The drug delivery balloon according to claim 1, characterized in that, The invasive portion is a cutting edge with a triangular cross-section, and the upper end of the drug delivery channel penetrates the two inclined surfaces of the cutting edge.

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