Drug-coated balloon catheter

Abstract

The present application discloses a drug-coated balloon catheter, comprising a push catheter, a drug-coated balloon fixed to the distal end of the push catheter, a sheath movably mounted on the outside of the push catheter and the drug-coated balloon, and a control handle disposed at the proximal end of the sheath. The control handle comprises a housing and a winding mechanism disposed on the housing, the proximal end of the sheath forming a reeling section connected to the reeling mechanism, and the reeling mechanism is used to reel the reeling section so that the distal end of the sheath moves toward the proximal end, thereby exposing the drug-coated balloon. The drug-coated balloon catheter can significantly shorten the length of the control handle, making it easier for doctors to operate; in addition, balloons of different lengths can be used with the same control handle, which expands the scope of application of the control handle and facilitates procurement and inventory management.

Description

Technical Field

[0001] The present application relates to the technical field of medical devices, and in particular to a drug-coated balloon catheter. Background Art

[0002] Arterial stenosis has long plagued humanity. To address this condition, treatments have progressed through the use of bare balloons, bare stents, and drug-eluting stents. However, each of these treatments has its own limitations. Drug-coated balloon catheters have emerged as a response to this challenge. These catheters not only expand the balloon to create a channel for blood flow, but also contain a drug that effectively inhibits smooth muscle cell proliferation, preventing restenosis.

[0003] Before expansion, the active drug coating on the surface of a conventional drug-coated balloon catheter is exposed to the vascular environment, making it susceptible to erosion by high-velocity blood flow, resulting in drug loss. Existing drug-coated balloon catheters employ a sheath over the balloon to reduce drug loss.

[0004] The existing drug-coated balloon catheter is provided with a proximal end of the sheath and a slider on the control handle fixedly connected together, and the slider is connected to a retractable tube arranged axially. When the operating slider moves axially toward the proximal end, the tube is folded axially toward the proximal end, and the sheath is driven by the slider to move proximally at the same time, exposing the drug-coated balloon to release the drug. However, the above-mentioned existing drug-coated balloon catheter has the following defects: as the length of the balloon increases, the axial movement distance of the slider and the length of the tube must be increased, which increases the length of the control handle (the length of the control handle can reach more than 35 cm), causing inconvenience for the operator to use and requiring matching with a longer guidewire; in addition, balloons of different lengths require different models of control handles, which limits the scope of application of the control handle, and too many models of control handles will also bring inconvenience to procurement and inventory management. Summary of the Invention

[0005] In view of this, the present application provides a drug-coated balloon catheter to solve the above problems.

[0006] An embodiment of the present application provides a drug-coated balloon catheter, comprising a push catheter and a drug-coated balloon fixed to the distal end of the push catheter, the drug-coated balloon catheter further comprising a sheath movably mounted outside the push catheter and the drug-coated balloon, and a control handle disposed at the proximal end of the sheath, the control handle comprising an outer shell and a winding mechanism disposed on the outer shell, the proximal end of the sheath forming a winding section connected to the winding mechanism, the winding mechanism being used to wind the winding section so that the distal end of the sheath moves toward the proximal end, thereby exposing the drug-coated balloon.

[0007] The drug-coated balloon catheter provided in the embodiment of the present application has a sheath provided on the outer cover of the drug-coated balloon, and a winding mechanism provided on the control handle. The proximal end of the sheath forms a reeling section connected to the reeling mechanism. The reeling section is wound by the reeling mechanism, so that the distal end of the sheath moves toward the proximal end, thereby exposing the drug-coated balloon. In this way, the sheath can protect the drug coating on the surface of the drug-coated balloon, reducing the drug loss rate during the delivery of the drug-coated balloon catheter. More importantly, because the reeling mechanism on the control handle controls the distal end of the sheath to move toward the proximal end in a reeling manner, the length of the control handle can be significantly shortened compared to the control method of the prior art by retracting the tube, greatly facilitating the doctor's operation. In addition, the reeling mechanism can expose balloons of different lengths by different degrees of winding of the reeling section. Therefore, balloons of different lengths can be used with the same control handle, expanding the scope of application of the control handle and facilitating procurement and inventory management. BRIEF DESCRIPTION OF THE DRAWINGS

[0008] In order to more clearly illustrate the embodiments of the present application or the technical solutions in the prior art, the following briefly introduces the drawings required for use in the embodiments or the description of the prior art. Obviously, the drawings described below are only some embodiments of the present application. For ordinary technicians in this field, other drawings can be obtained based on these drawings without paying any creative labor.

[0009] Figure 1 This is a schematic structural diagram of the drug-coated balloon catheter in the first state provided by the first embodiment of the present application.

[0010] Figure 2 yes Figure 1 Schematic diagram of the structure of the drug-coated balloon catheter in the second state.

[0011] Figure 3 yes Figure 2 Schematic diagram of the winding mechanism of the drug-coated balloon catheter winding the reeling section of the sheath.

[0012] Figure 4 yes Figure 3 Schematic diagram of the structure of the cutting mechanism of the drug-coated balloon catheter.

[0013] Figure 5 yes Figure 3 Schematic diagram of the cross-section of the cutting mechanism, sheath and push catheter of the drug-coated balloon catheter along the sheath axis.

[0014] Figure 6 yes Figure 3 Schematic diagram of the radial cross-section of the retracted segment and winding axis of the drug-coated balloon catheter.

[0015] Figure 7 yes Figure 3 Schematic diagram of the radial cross-section of the sheath and cutting blade of the drug-coated balloon catheter.

[0016] Figure 8 yes Figure 3 Schematic diagram of the radial cross-section of the retracted section of the drug-coated balloon catheter in the non-retracted state.

[0017] Figure 9 This is a schematic structural diagram of a drug-coated balloon catheter provided in the second embodiment of the present application.

[0018] Figure 10 yes Figure 9 A three-dimensional exploded view of the gear rack, winding mechanism, and drive mechanism of the drug-coated balloon catheter.

[0019] Figure 11 yes Figure 9 Schematic diagram of the reeling section of the reeling sheath of the reeling mechanism of the drug-coated balloon catheter.

[0020] Figure 12 yes Figure 9 Schematic diagram of the structure of the cutting mechanism of the drug-coated balloon catheter.

[0021] Figure 13 yes Figure 9 A cross-sectional view of the cutting mechanism, sheath, and push catheter of the drug-coated balloon catheter along the sheath axis.

[0022] Figure 14 This is a simplified structural diagram of the drug-coated balloon catheter provided in the third embodiment of the present application.

[0023] Figure 15 This is a simplified structural diagram of the drug-coated balloon catheter provided in the fourth embodiment of the present application.

[0024] Description of main component symbols

[0025] Drug-coated balloon catheters 100, 200, 300, and 400

[0026] Catheter hub 10

[0027] Push catheter 20

[0028] Drug-coated balloon 30

[0029] Sheath 40

[0030] Winding section 401

[0031] Non-rewinding section 402

[0032] Volume 1 Ending 41

[0033] Volume 2, Ending 42

[0034] Auxiliary segmentation structure 403

[0035] Control handle 50

[0036] Housing 51

[0037] Through holes 5101, 5102

[0038] Cavity 510

[0039] First housing 511

[0040] Avoidance 5111

[0041] Second housing 512

[0042] Gear rack 52

[0043] First bracket 521

[0044] Second bracket 522

[0045] Extension plate 5221

[0046] Containment Space 523

[0047] Winding mechanism 53

[0048] Winding shaft 530

[0049] First winding shaft 531

[0050] Second winding shaft 532

[0051] Buffer sleeve 54

[0052] Power element 55

[0053] Connecting portion 551

[0054] Operation unit 552

[0055] Driving mechanism 57

[0056] Gear 570

[0057] Gear Department 5701

[0058] Rotating shaft 5702

[0059] Bushing 5703

[0060] First gear 571

[0061] Second gear 572

[0062] Third gear 573

[0063] Fourth gear 574

[0064] Limiting piece 58

[0065] Limited space 580

[0066] Cutting mechanism 60

[0067] Cutting base 61

[0068] Through hole 610

[0069] Card slot 611

[0070] Cutting blade 63

[0071] Cutting edge 631

[0072] The following specific implementation methods will further illustrate this application in conjunction with the above-mentioned drawings. DETAILED DESCRIPTION

[0073] The following will be combined with the accompanying drawings in the embodiments of this application to clearly and completely describe the technical solutions in the embodiments of this application. Obviously, the embodiments described are only part of the embodiments of this application, not all of the embodiments. Based on the embodiments of this application, all other embodiments obtained by ordinary technicians in this field without making creative efforts are within the scope of protection of this application.

[0074] First, it should be noted that in the field of interventional medicine, the end of an instrument closest to the operator is generally referred to as the proximal end, and the end away from the operator is generally referred to as the distal end. The circumferential direction is the direction around the axis of an object such as a cylinder or tube (perpendicular to the axis and also perpendicular to the cross-sectional radius); the radial direction is the direction along the diameter or radius. It is worth noting that the "end" used in terms such as "proximal end," "distal end," "one end," "other end," "first end," "second end," "initial end," "terminal end," "two ends," "free end," "upper end," and "lower end" is not limited to the end, endpoint, or end face, but also includes the portion extending an axial distance and / or radial distance from the end, endpoint, or end face on the component to which the end, endpoint, or end face belongs. Unless otherwise defined, all technical and scientific terms used in this application have the same meaning as commonly understood by those skilled in the art to which this application belongs. The customary terms used in this specification are for the purpose of describing specific embodiments only and are not to be construed as limiting this application. The terms "first," "second," and the like in the specification and claims of this application and the accompanying drawings are used to distinguish different objects, not to describe a specific order. Unless the context clearly indicates otherwise, the singular forms "a", "an" and "the" are intended to include the plural forms as well. The terms "including" and any variations thereof are intended to cover non-exclusive inclusions. In addition, the present application can be implemented in a variety of different forms and is not limited to the embodiments described in this embodiment. The purpose of providing the following specific embodiments is to facilitate a clearer and more thorough understanding of the disclosure of this application, wherein words indicating directions such as up, down, left, and right only refer to the position of the structure shown in the corresponding drawings.

[0075] The following description is for the purpose of illustrating the general principles of the present invention and is not intended to limit the scope of the present invention. The scope of protection of the present invention shall be determined by the appended claims.

[0076] Please also refer to Figures 1 to 3 The drug-coated balloon catheter 100 provided in the first embodiment of the present application includes a pushing catheter 20, a drug-coated balloon 30 fixed to the distal end of the pushing catheter 20, a sheath 40 movably arranged outside the pushing catheter 20 and the drug-coated balloon 30, and a control handle 50 arranged at the proximal end of the sheath 40.

[0077] The control handle 50 includes a shell 51 and a winding mechanism 53 arranged on the shell 51. The proximal end of the sheath 40 forms a reeling section 401 connected to the reeling mechanism 53. The reeling mechanism 53 is used to reel the reeling section 401 so that the distal end of the sheath 40 moves toward the proximal end, thereby exposing the drug-coated balloon 30.

[0078] It should be noted that in Figure 1In the first state shown, the drug-coated balloon 30 of the drug-coated balloon catheter 100 is housed in the sheath 40, that is, the drug-coated balloon 30 is not expanded. The sheath 40 protects the drug coating on the surface of the drug-coated balloon 30, reducing the drug loss rate during the delivery process of the drug-coated balloon catheter 100. Figure 2 In the second state shown, the drug-coated balloon 30 of the drug-coated balloon catheter 100 is exposed outside the sheath 40 and the drug-coated balloon 30 can be fully expanded, so that the drug coating on the surface of the drug-coated balloon 30 can be released and transferred to the blood vessel wall to exert its drug effect.

[0079] Please also refer to Figures 3 to 8 The proximal end of the sheath 40 is divided into at least one reeling segment 401 along the axial direction of the sheath 40, that is, each reeling segment 401 includes two side edges (not shown) extending along the axial direction of the sheath 40 and capable of moving away from each other. The push catheter 20 can pass through the reeling segment 401 between the two side edges, so that the reeling mechanism 53 can only reel the reeling segment 401 without affecting the push catheter 20. The reeling mechanism 53 can smoothly reel the reeling segment 401. The reeling mechanism 53 includes at least one reeling shaft 530. In one embodiment, all reeling segments 401 are reeled around the same reeling shaft 530. In other embodiments, each reeling segment 401 is reeled around a corresponding reeling shaft 530.

[0080] like Figure 1 and Figures 3 to 5 As shown, in this embodiment, the drug-coated balloon catheter 100 further includes a cutting mechanism 60 for rapidly cutting the proximal end of the sheath 40 to form a reeled segment 401. The cutting mechanism 60 is configured to axially cut the proximal end of the sheath 40 while the reeling mechanism 53 is reeling the reeled segment 401, thereby increasing the length of the reeled segment 401. The cutting mechanism 60 can be directly fixed to the housing 51 or fixed to the housing 51 via other components. The central axis of the cutting mechanism 60 is collinear with the central axis L1 of the sheath 40, so that the proximal end of the sheath 40 is cut axially into at least one reeled segment 401.

[0081] The cutting mechanism 60 includes a cutting base 61 and a cutting blade 63 disposed on the cutting base 61. It is understood that in other embodiments, the cutting mechanism 60 may include multiple cutting blades 63. The number of cutting blades 63 corresponds to the number of reeling sections 401. Those skilled in the art may design the number of cutting blades 63 based on actual needs, and this application does not impose any specific limitation thereto.

[0082] In which, the cutting base 61 is provided with a through hole 610 along the axial direction for the sheath 40 to pass through. The cutting blade 63 extends into the through hole 610. The cutting blade 63 includes a cutting edge 631. The extension direction of the cutting edge 631 intersects with the central axis L1 of the sheath 40, that is, the extension direction of the cutting edge 631 forms an angle α with the central axis L1 of the sheath 40, wherein preferably 90°≥α≥15°. A card slot 611 that is connected to the through hole 610 is provided at the distal end of the cutting base 61. The cutting blade 63 is snapped into the card slot 611 and extends into the through hole 610. Optionally, in some embodiments, the cutting edge 631 is perpendicular to the axial direction of the sheath 40, that is, the extension direction of the cutting edge 631 is perpendicular to the central axis L1 of the sheath 40.

[0083] Among them, the end of the cutting edge 631 facing away from the cutting base 61 is located between the outer wall of the push catheter 20 and the inner wall of the sheath 40 to prevent the cutting blade 63 from scratching the push catheter 20 when cutting the sheath 40. In order to ensure the smoothness of cutting the sheath 40, the cutting blade 63 is made of a hard material, such as but not limited to stainless steel. The cutting base 61 supports the cutting blade 63, and the hardness of the cutting base 61 can be less than the hardness of the cutting blade 63 to save costs. In this embodiment, the cutting blade 63 is made of stainless steel 440C, and the cutting base 61 is made of stainless steel 304. In some other embodiments, the cutting blade 63 can also be replaced by other cutting elements such as a wire body.

[0084] In some alternative embodiments, the drug-coated balloon catheter 100 can omit the cutting mechanism 60, thereby simplifying the structure of the drug-coated balloon catheter 100 and reducing production costs. In order to facilitate the separation of the proximal end of the sheath 40, the proximal end of the sheath 40 is provided with at least one auxiliary separation structure 403 extending in the axial direction. The auxiliary separation structure 403 includes but is not limited to at least one of a fold, a plurality of hollow seams arranged at intervals, and a thinning groove. By pulling the two sides of the auxiliary separation structure 403, the proximal end of the sheath 40 can be separated through the auxiliary separation structure 403 to form a retracted section 401. It can be understood that in some embodiments, the drug-coated balloon catheter 100 includes a cutting mechanism 60, and the proximal end of the sheath 40 is further provided with an auxiliary separation structure 403 to further quickly cut the proximal end of the sheath 40.

[0085] The distal end of the sheath 40 can move axially along the delivery catheter 20. The sheath 40 is preferably a tubular structure that can be positioned over the unexpanded drug-coated balloon 30. The sheath 40 is made of a biocompatible material. Biocompatible materials include, but are not limited to, materials with a low coefficient of friction, such as e-PTFE, PTFE, FEP, or PET. Preferably, to facilitate the axial sliding of the distal end of the sheath 40 along the delivery catheter 20, the sheath 40 is made of a material with a low coefficient of friction.

[0086] Optionally, to facilitate the extension of the drug-coated balloon 30 from the sheath 40, the distal end of the sheath 40 may also be provided with at least one auxiliary segmentation structure 403 extending axially. Specifically, after the drug-coated balloon 30 is delivered to the lesion site, the sheath 40 is withdrawn, that is, the winding mechanism 53 winds the reeling section 401, so that the distal end of the sheath 40 moves toward the proximal end of the delivery catheter 20. The distal auxiliary segmentation structure 403 can be expanded by the drug-coated balloon 30 until it tears, while the proximal auxiliary segmentation structure 403 can be cut by the cutting mechanism 60 or torn by the reeling force transmitted by the reeling shaft 530, so that the drug-coated balloon 30 can extend from the side of the sheath 40 near the distal end and be exposed outside the sheath 40, thereby exposing the drug-coated balloon 30 to the vascular environment of the lesion site. The drug-coated balloon 30 is then inflated and expanded to release the drug coating and transfer it to the inner wall of the blood vessel at the lesion site.

[0087] like Figure 3 and Figures 6 to 8 As shown, the reeling section 401 has a reeled state and a non-reeled state. The sheath 40 also includes a non-reeling section 402 adjacent to the reeling section. The radial cross-section of the reeling section 401 is an open-loop structure, which facilitates the reeling section 401 to deviate from the push catheter 20 and be wound on the winding shaft 530. The radial cross-section of the non-reeling section 402 is a closed-loop structure to prevent the drug-coated balloon 30 from being washed away by high-speed blood flow and causing loss of drug, thereby greatly reducing the drug loss rate of the drug-coated balloon catheter 100 during delivery. Because the sheath 40 is a hollow tubular structure, in the non-reeled state, the radial cross-section of each reeling section 401 is roughly arc-shaped. In the retracted state, each retracted section 401 is relatively far away from the push catheter 20 in the radial direction of the push catheter 20 compared to other parts of the sheath 40 (i.e., the non-retracted section 402). In this way, it is convenient to increase the axial length of the retracted section 401 after dividing the proximal end of the sheath 40, and avoid interference with the push catheter 20 when the winding mechanism 53 winds the retracted section 401 of the sheath 40.

[0088] Specifically, the line L2 on which the reeling section 401 lies when reeled deviates from the central axis L1 of the non-reeling section 402. That is, the reeling section 401 deviates relative to the non-reeling section 402, forming an angle β between the reeling section 401 and the non-reeling section 402. Optionally, the angle β is acute to prevent the sheath from breaking due to excessive deviation of the reeling section 401 and to ensure that the reeling section 401 does not interfere with the push catheter 20 when being reeled on the reeling shaft 530.

[0089] In this embodiment, the winding mechanism 53 includes a winding shaft 530. The central axis of the winding shaft 530 is perpendicular to the central axis of the sheath 40. The proximal end of the sheath 40 is divided into a reeling section 401 along the axial direction of the sheath 40. The radial cross-section of the reeling section 401 is roughly C-shaped. Specifically, an opening 4011 is cut out along the axial direction of the proximal end of the sheath 40 to form the reeling section 401, so that the reeling section 401 deviates from the push catheter 20 and rotates around the winding shaft 530. The distal end of the reeling section 401 is fixedly connected to the non-reeling section 402, and the proximal end of the reeling section 401 is fixed to the winding shaft 530.

[0090] Please refer again Figure 1 and Figure 3 The control handle 50 further includes a power element 55 fixedly connected to the winding shaft 530. The power element 55 is used to control the rotation of the winding shaft 530 to wind up the reel segment 401. In other embodiments, the proximal end of the sheath is divided into at least two reel segments along the axial direction of the sheath, and at least two reel segments are each wound on the winding shaft. The power element is used to control the rotation of the winding shaft to wind up the at least two reel segments.

[0091] The power element 55 can be either a mechanical element or an electric element. In this embodiment, the power element 55 is a mechanical element, such as a mechanical knob. The mechanical knob includes a connecting portion 551 fixed to the winding shaft 530 and an operating portion 552 fixed to the side of the connecting portion 551 facing away from the winding shaft 530. The connecting portion 551 extends vertically from the middle of the operating portion 552. The connecting portion 551 and the winding shaft 530 can be integrally formed or fixedly connected together via a mounting structure. The mounting structure can include, but is not limited to, a snap-fit ​​structure or a threaded structure. The operating portion 552 is exposed from the housing 51 and is rotatable relative to the housing 51 for user operation. Specifically, when the operating portion 552 is rotated in a first predetermined direction, the reeling section 401 rotates about the central axis of the winding shaft 530, causing the distal end of the sheath 40 to move toward the proximal end of the sheath 40, thereby causing the drug-coated balloon 30 to extend from the sheath 40. The first predetermined direction can be clockwise or counterclockwise.

[0092] The drug-coated balloon catheter also includes a catheter hub 10. The catheter hub 10 is positioned proximal to the delivery catheter 20. The catheter hub 10 can be secured directly to the delivery catheter 20 or via a control handle 50. The catheter hub 10 is provided with a guidewire port 11 for inserting a guidewire and an inflation port 13 for injecting fluid to inflate the balloon.

[0093] The control handle 50 also includes a buffer sleeve 54 fixedly mounted on the distal end of the housing 51. The central axis of the buffer sleeve 54 is collinear with the central axis L1 of the push catheter 20 and the sheath 40. The push catheter 20 and the sheath 40 are disposed within the buffer sleeve 54, thereby preventing them from being bent. The buffer sleeve 54 can be injection molded from a soft rubber material, such as, but not limited to, silicone or thermoplastic polyurethane elastomer.

[0094] Specifically, the housing 51 includes a first shell 511 and a second shell 512 that fit together and are fixed to each other. The first shell 511 and the second shell 512 can be fixedly connected together by a snap-fit ​​structure, a screw locking mechanism, etc. The first shell 511 and the second shell 512 can both be made of hard plastic material to save costs. The hard material includes, but is not limited to, acrylonitrile butadiene styrene plastic (ABS). The first shell 511 and the second shell 512 enclose a cavity 510 having two opposite through holes 5101 and 5102 (see FIG. 5 ). Figure 9 The buffer sleeve 54 is snapped into the through hole 5101, and the catheter hub 10 is snapped into the through hole 5102. The push catheter passes through the buffer sleeve 54 and connects to the catheter hub 10. The first housing 511 also defines a clearance opening 5111 for the operating portion 552 of the power element 55 to pass through, facilitating user operation. The cutting mechanism 60 and the winding mechanism 53 are both housed within the cavity 510 of the housing 51.

[0095] The interior of the push catheter 20 is axially provided with a guidewire cavity and a filling cavity. The guidewire cavity is isolated from the filling cavity and is arranged side by side. The portion of the push catheter 20 that passes through the drug-coated balloon 30 is provided with a balloon filling port (not shown) that is in communication with the drug-coated balloon 30. The guidewire port 11 is in communication with the guidewire cavity so that the guidewire passes through the guidewire port 11 and through the guidewire cavity. The guidewire cavity axially penetrates the distal end and the proximal end of the push catheter 20. The filling cavity is in communication with the filling port 13 and the balloon filling port. Thus, the filling port 13, the filling cavity and the balloon filling port form a channel for filling or relieving pressure on the drug-coated balloon 30, so as to enable the introduction or extraction of fluid into or out of the drug-coated balloon 30 to fill or relieve pressure on the drug-coated balloon 30. Specifically, filling port 13 can be connected to an external pressure pump, and liquid enters or flows out of the drug-coated balloon 30 through filling port 13, the filling cavity, and the balloon filling port, thereby achieving inflation or pressure relief of the drug-coated balloon 30. It is understood that the user can set one or more filling cavities within the delivery catheter 20 based on the actual condition of the diseased tissue and the time required for filling, and accordingly, one or more filling ports 13 can be set on the catheter adapter 10.

[0096] At least one drug-coated balloon 30 is fixedly provided at the distal end of the push catheter 20. The drug-coated balloon 30 can be fixed by welding, bonding, or fixing with a fixing member, etc., which are generally used in the art and will not be described in detail here.

[0097] The drug-coated balloon 30 is an expandable balloon. Specifically, the drug-coated balloon 30 can be selectively filled or drained with liquid, thereby improving the wall adhesion of the drug-coated balloon 30. The outer wall of the drug-coated balloon 30 is provided with a drug coating. The drug coating can cover the entire outer wall of the drug-coated balloon 30. In another embodiment, the drug coating can cover a portion of the outer wall of the drug-coated balloon 30. In one embodiment, the active drug coating contains an active drug that inhibits smooth muscle cell proliferation. Optionally, in another optional embodiment, the drug coating also includes a carrier. The carrier can be used to promote the rapid release of the active drug from the outer wall of the drug-coated balloon 30 or promote absorption by diseased tissue. The carrier is, for example, but not limited to, an organic acid salt or a polyol. In this embodiment, mannitol is used as the carrier. In this embodiment, the active drug is a drug that inhibits smooth muscle cell proliferation (such as paclitaxel, rapamycin, etc.). In this embodiment, paclitaxel is used.

[0098] The process of treating a vascular lesion using the drug-coated balloon catheter 100 provided in the first embodiment of the present application includes the following steps: first, the distal end of the drug-coated balloon catheter 100 is delivered to the vicinity of the vascular lesion, and the drug-coated balloon 30 is aligned with the lesion. The winding mechanism 53 is controlled to wind the reeling section 401 so that the distal end of the sheath 40 moves proximally, i.e., the distal end of the sheath 40 moves along the axial direction of the delivery catheter 20 toward the proximal end of the delivery catheter 20 until the drug-coated balloon 30 is exposed outside the sheath 40. At this point, the drug-coated balloon 30 is exposed to the vascular lesion; the drug-coated balloon 30 is inflated, and after the drug-coated balloon 30 is inflated, the lesion is fully dilated, and the drug coating 32 is released from the surface of the drug-coated balloon 30 and transferred to the vascular wall to exert its drug effect; finally, the drug-coated balloon 30 is depressurized and removed from the patient, completing the procedure.

[0099] The drug-coated balloon catheter 100 provided in an embodiment of the present application is provided with a sheath 40 on the outer cover of the drug-coated balloon 30, and a winding mechanism 53 is provided on the control handle 50. The proximal end of the sheath 40 forms a winding section 401 connected to the winding mechanism 53. The winding section 401 is wound by the winding mechanism 53, so that the distal end of the sheath 40 moves toward the proximal end, thereby exposing the drug-coated balloon 30. In this way, the sheath 40 can protect the drug coating on the surface of the drug-coated balloon 30, reducing the drug loss rate of the drug-coated balloon catheter during delivery; more importantly, since the winding mechanism 53 on the control handle 50 controls the movement of the distal end of the sheath 40 to the proximal end in a winding manner, compared with the control method of the prior art through the extension and contraction of the tube, the length of the control handle can be significantly shortened, greatly facilitating the doctor's operation; in addition, the winding mechanism 53 can expose balloons of different lengths according to the different degrees of winding of the retracted section 401, so balloons of different lengths can be used with the same control handle, which expands the scope of application of the control handle and facilitates procurement and inventory management.

[0100] Please also refer to Figure 9 and Figure 10 The structure of the drug-coated balloon catheter 200 provided in the second embodiment of the present application is similar to that of the drug-coated balloon catheter 100 of the first embodiment, except that the winding mechanism 53 includes at least two winding shafts 530, the sheath 40 includes at least two reeling segments 401, and the control handle 50 further includes a drive mechanism 57 disposed within the housing 51. The drive mechanism 57 is configured to drive each winding shaft 530 to rotate to reel in the corresponding reeling segment 401. The central axis of each winding shaft 530 is perpendicular to the central axis of the sheath 40.

[0101] The drive mechanism 57 includes at least two gears 570 drivingly connected to at least two winding shafts 530. Each gear 570 includes a coaxially arranged gear portion 5701 and a rotating shaft portion 5702. Each winding shaft 530 is fixed to and coaxially arranged with the corresponding rotating shaft portion 5702. One of the at least two gears 570 serves as a driving gear, and the remaining gears 570 serve as driven gears.

[0102] In this embodiment, the at least two winding shafts 530 include a first winding shaft 531 and a second winding shaft 532, and the at least two reeling sections 401 include a first reeling section 41 and a second reeling section 42. The proximal ends of the first reeling section 41 and the proximal ends of the second reeling section 42 are fixed to the first winding shaft 531 and the second winding shaft 532, respectively. The first reeling section 41 is located at the end of the first winding shaft 531 away from the gear portion 5701 associated with the first winding shaft 531, and the second reeling section 42 is located at the end of the second winding shaft 532 away from the gear portion 5701 associated with the second winding shaft 532.

[0103] The at least two gears 570 include a first gear 571, a second gear 572, a third gear 573, and a fourth gear 574, which mesh in sequence. The first winding shaft 531 and the second winding shaft 532 are fixed to the rotating shaft portion 5702 of the first gear 571 and the rotating shaft portion 5702 of the fourth gear 574, respectively. When the second gear 572 or the third gear 573 serves as the driving gear, the winding direction of the first reeling section 41 is opposite to the winding direction of the second reeling section 42. In this way, the first reeling shaft 531 and the second reeling shaft 532 can respectively wind up the first reeling section 41 and the second reeling section 42, thereby improving the reliability of winding the proximal end of the sheath 40.

[0104] Specifically, in this embodiment, the first winding shaft 531 and the rotating shaft portion 5702 of the first gear 571 are integrally formed, and the second winding shaft 532 and the rotating shaft portion 5702 of the fourth gear 574 are also integrally formed. That is, the rotating shaft portion 5702 of the first gear 571 can serve as the first winding shaft 531, and the rotating shaft portion 5702 of the fourth gear 574 can serve as the second winding shaft 532. In other embodiments, the first winding shaft 531 and the rotating shaft portion 5702 of the first gear 571, and the second winding shaft 532 and the rotating shaft portion 5702 of the fourth gear 574 can be welded together or detachably fixed together. In this way, the first winding shaft 531 and the first gear 571, and the second winding shaft 532 and the fourth gear 574 can rotate synchronously, thereby ensuring smooth and balanced winding of the proximal end of the sheath 40.

[0105] The first and second winding sections 41, 42 can be fixed to the outer or inner walls of the first and second winding shafts 531, 532, respectively, by bonding. In this embodiment, both the first and second winding shafts 531, 532 are provided with through-holes 5301. The proximal end of the first winding section 41 passes through the through-holes 5301 of the first winding shaft 531 and is tightly wound around the outer wall of the first winding shaft 531 a predetermined number of times. The proximal end of the second winding section 42 also passes through the through-holes 5301 of the second winding shaft 532 and is tightly wound around the second winding shaft 532 a predetermined number of times. The predetermined number of times is 3-4. In other embodiments, the first and second winding sections 41, 42 can also be fixed to the first and second winding shafts 531, 532, respectively, by bonding, crimping, snap-fitting, or screw-locking structures.

[0106] Please see again Figures 9 to 11In this embodiment, the second gear 572 serves as the driving gear, and the first, third, and fourth gears 573 and 574 serve as driven gears, with the third gear 573 serving as the driven reversing gear. When the second gear 572 rotates in a first direction, it drives the first and third gears 571 and 573 to rotate in a second direction opposite to the first direction, while the fourth gear 574 rotates in the first direction. At this point, the first and fourth gears 571 and 574 drive the corresponding first and second winding shafts 531 and 532 to rotate synchronously, respectively. However, the first and second winding shafts 531 and 532 rotate in opposite directions. The winding direction of the first winding section 41 adapts to the rotation direction of the first winding section 531, and the winding direction of the second winding section 42 adapts to the rotation direction of the second winding section 532. As a result, the first and second winding shafts 531 and 532 continuously wind the corresponding first and second winding sections 41 and 42 in opposite directions, respectively. In this way, the distal end of the sheath 40 moves toward the proximal end to expose the drug-coated balloon. The winding direction of the first reeling section 41 is opposite to the winding direction of the second reeling section 42, which helps the distal ends of the first reeling section 41 and the second reeling section 4 to be continuously separated or separated under the pulling action of the first reeling shaft 531 and the second reeling shaft 532.

[0107] Optionally, the first gear 571 and the fourth gear 574 are symmetrically arranged about the central axis of the sheath 40, and the second gear 572 and the third gear 573 are symmetrically arranged about the central axis of the sheath 40, with a gap between the first gear 571 and the fourth gear 574. This increases the winding space of the first winding shaft 531 and the second winding shaft 532, preventing interference between the first winding shaft 531 and the second winding shaft 532 when winding the first winding section 41 and the second winding section 42, respectively, thereby improving the smoothness and balance of the winding action.

[0108] To ensure the reliability of the rotation of the at least two gears 570, the at least two gears 570 are made of a polymer material or a metal material. The polymer material includes, but is not limited to, polyoxymethylene (POM) and nylon. The metal material includes, but is not limited to, stainless steel.

[0109] Optionally, the control handle 50 further includes a power element 55 fixedly connected to the drive gear. The power element 55 is used to control the rotation of the drive gear, thereby driving the driven gear and at least two winding shafts 530 to rotate and wind at least two winding segments 401. The power element in the first embodiment is applicable to the power element 55 in the second embodiment and will not be described in detail herein. In the second embodiment, the power element 55 is fixedly connected to the drive gear.

[0110] In this embodiment, the control handle 50 further includes a gear frame 52 fixedly connected to the housing 51. At least two gears 570 are rotatably connected to the gear frame 52. Each winding shaft 530 includes an extending section 5301 extending from the gear frame 52, and each reeling section 401 is wound around the extending section 5301 of the corresponding winding shaft 530.

[0111] Specifically, the gear rack 52 includes a first bracket 521 and a second bracket 522 that cooperate and are fixed to each other. The first bracket 521 and the second bracket 522 are detachably connected together to facilitate the user to install and remove the reeling section 401. The first bracket 521 and the second bracket 522 together enclose a receiving space 523 for accommodating at least two gears 570. The second bracket 522 is a plate-like structure. An extension plate 5221 for fixing the cutting mechanism 60 is provided at the far end of the second bracket 522. The cutting mechanism 60 is provided on the side of the extension plate 5221 away from the first bracket 521 to prevent the reeling section 401 from interfering with the rotation of the corresponding two gears 370 when winding on the winding shaft 530.

[0112] Each reeling segment 401 is offset relative to the non-reeling segment 402, away from the central axis L1 of the sheath 40. Specifically, the extension direction of each reeling segment 401 forms an angle β with the axial direction of the sheath 40. Optionally, the angle β is acute to prevent breakage of the reeling segment 401 due to excessive deviation. Thus, by designing the extension plate 5221 to expose the first bracket 521, more space is created below the gear rack 52 to accommodate the reeled reeling segment 401. This further ensures that the reeling mechanism 53 does not interfere with the push catheter 20 when reeling the reeling segment 401 of the sheath 40.

[0113] Optionally, a limit member 58 is provided at one end of the extending section 5301 of each winding shaft 530 away from the gear frame 52. A limit space 580 is formed between the limit member 58 and the gear frame 52, so that each reeling section 401 is located within the corresponding limit space 580, thereby preventing each reeling section 401 from being separated from the corresponding winding shaft 530, thereby ensuring the reliability of the reeling section 401 being wound on the winding shaft 530, so that the distal end of the sheath 40 can move along the axial direction of the push catheter 20, so that the drug-coated balloon 30 can extend out of the sheath 40.

[0114] Please see again Figure 9 and Figure 10 The drive mechanism 57 further includes a plurality of sleeves 5703 fixed to the gear frame 52. Each gear 570 is rotatably connected to its corresponding sleeves 5703 at both ends. This reduces friction between the gear 570 and the gear frame 52, thereby improving the smoothness of winding of the reeling section 401 of the sheath 40. It will be appreciated that the length of the reeling section 401 increases as the number of turns of the reeling section increases.

[0115] Please also refer to Figure 9 and Figures 12 to 13 , Figure 12 FIG. 1 is a schematic structural diagram of the cutting mechanism 60 of the drug-coated balloon catheter 200 ; Figure 13 FIG2 shows a cross-sectional view of the cutting mechanism 60, the sheath 40, and the push catheter 20 of the drug-coated balloon catheter 200 along the sheath axis. In the second embodiment, the structure of the cutting mechanism 60 is similar to that of the first embodiment, except that two cutting blades 63 are provided on the cutting base 61 of the cutting mechanism 60.

[0116] The two cutting blades 63 are symmetrically arranged about the central axis L1 of the sheath 40. This ensures that the proximal end of the sheath 40, cut by the cutting blades 63, produces a reeling section 401 of the same size, thereby ensuring balanced reeling of the reeling section 401. The end of the cutting edge 631 facing away from the cutting base 61 is located between the outer wall of the push catheter 20 and the inner wall of the sheath 40. Specifically, the distance between the two cutting blades 63 is approximately 2mm-5mm less than the inner diameter of the sheath 40 and approximately 2mm-5mm greater than the outer diameter of the push catheter 20. This prevents the cutting blades 63 from scratching the push catheter 20 when cutting the sheath 40.

[0117] The drug-coated balloon catheter provided in this embodiment, based on the same principles as the previous embodiment, also significantly shortens the control handle, facilitating operation for physicians. Balloons of varying lengths can be used with the same control handle, expanding its applicability and facilitating procurement and inventory management. This will not be further elaborated here. Furthermore, the control handle of this embodiment incorporates four gears connected to the winding mechanism, enhancing the smoothness and balance of the winding of the two reeling sections.

[0118] See also Figure 14 In the third embodiment, the structure of the drug-coated balloon catheter 300 is similar to that of the drug-coated balloon catheter 200 of the second embodiment, except that at least two gears 570 include a first gear 571, a second gear 572, and a third gear 573 that mesh with each other in sequence. The first winding shaft 531 and the second winding shaft 532 are fixed to the rotating shaft portions of the first gear 571 and the third gear 573, respectively. When any of the first gear 571, the second gear 572, and the third gear 573 can serve as a driving gear, the winding direction of the first winding section 41 is the same as the winding direction of the second winding section 42. This increases the distance between the first winding shaft 531 and the second winding shaft 532, allowing the first winding section 41 and the second winding section 42 to be wound relatively far apart without interfering with each other.

[0119] For example, when the second gear 572 acts as a driving gear to rotate in the counterclockwise direction D1, it drives the first gear 571 and the third gear 573 to rotate in the clockwise direction D2. At this time, the first winding segment 41 and the second winding segment 42 fixed on the first winding shaft 531 and the second winding shaft 532 respectively are pulled, that is, the first winding segment 41 and the second winding segment 42 are wound on the first winding shaft 531 and the second winding shaft 532 in the clockwise direction D2, so that the distal end of the sheath 40 moves axially toward the proximal end of the push catheter 20, thereby exposing the drug-coated balloon 30.

[0120] In other embodiments, the first winding shaft 531 and the second winding shaft 532 are fixed to the rotating shaft portion of the second gear 572 and the rotating shaft portion of the third gear 573, respectively, the first gear 571 serves as a driving gear, and the winding direction of the first winding section 41 is opposite to the winding direction of the second winding section 42. Alternatively, the first winding shaft 531 and the second winding shaft 532 are fixed to the rotating shaft portion of the first gear 571 and the rotating shaft portion of the second gear 572, respectively, the third gear 573 serves as a driving gear, and the winding direction of the first winding section 41 is opposite to the winding direction of the second winding section 42.

[0121] The drug-coated balloon catheter provided in this embodiment, based on the same principles as the aforementioned embodiments, also significantly shortens the length of the control handle, facilitating operation by physicians. Balloons of varying lengths can be used with the same control handle, expanding its applicability and facilitating procurement and inventory management. This will not be further discussed here. Furthermore, the control handle is equipped with three gears connected to the winding mechanism. These three gears are arranged side by side, perpendicular to the central axis of the sheath, further reducing the length of the control handle and making it smaller overall.

[0122] See also Figure 15 The structure of the drug-coated balloon catheter 400 of the fourth embodiment is similar to that of the drug-coated balloon catheter 200 of the second embodiment, except that at least two gears 570 include a first gear 571 and a second gear 572 meshing with the first gear 571, and the first winding shaft 531 and the second winding shaft 532 are respectively fixed on the rotating shaft portion of the first gear 571 and the rotating shaft portion of the second gear 572. Either the first gear 571 or the second gear 572 can serve as the driving gear, and the winding direction of the first winding section 41 is opposite to the winding direction of the second winding section 42.

[0123] When the first gear 571 rotates in the counterclockwise direction D1, the second gear 572 is driven to rotate in the clockwise direction D2. At this time, the first winding segment 41 and the second winding segment 42 fixed on the first winding shaft 531 and the second winding shaft 532 respectively are pulled, that is, the first winding segment 41 is wound on the first winding shaft 531 in the counterclockwise direction D1, and the second winding segment 42 is wound on the second winding shaft 532 in the clockwise direction D2, so that the distal end of the sheath 40 moves axially toward the proximal end of the push catheter 20, thereby exposing the drug-coated balloon 30.

[0124] The drug-coated balloon catheter provided in this embodiment, based on the same principles as the above-mentioned embodiments, can also significantly shorten the length of the control handle, making it easier for doctors to operate. Balloons of different lengths can be used with the same control handle, expanding the control handle's applicability and facilitating procurement and inventory management. This will not be discussed in detail here. Furthermore, the control handle is equipped with two gears that are connected to the winding mechanism. The two gears are arranged side by side in a direction perpendicular to the central axis of the sheath, which not only improves the winding smoothness and balance of the two reeling sections but also helps to further reduce the length of the control handle, thereby making the overall size of the control handle smaller.

[0125] The above is a detailed introduction to the embodiments of the present application. Specific examples are used herein to illustrate the principles and implementation methods of the present application. The description of the above embodiments is only used to help understand the method and core idea of ​​the present application. At the same time, for those skilled in the art, according to the idea of ​​the present application, there may be changes in the specific implementation methods and application scope. In summary, the content of this specification should not be understood as a limitation on the present application.

Claims

1. A drug-coated balloon catheter, comprising a delivery catheter and a drug-coated balloon fixed to the distal end of the delivery catheter, characterized in that: The drug-coated balloon catheter further includes a sheath movably sleeved over the push catheter and the drug-coated balloon, and a control handle disposed at the proximal end of the sheath. The control handle includes a housing and a winding mechanism disposed on the housing. The proximal end of the sheath forms a reeling section connected to the reeling mechanism. The reeling mechanism is used to reel the reeling section so that the distal end of the sheath moves toward the proximal end, thereby exposing the drug-coated balloon. The winding mechanism on the control handle controls the distal end of the sheath to move toward the proximal end in a winding manner, thereby shortening the length of the control handle, and balloons of different lengths can be used with the same control handle; The proximal end of the sheath is divided into at least one winding segment along the axial direction of the sheath, and the winding mechanism includes at least one winding shaft; all the winding segments are wound around the same winding shaft, or each of the winding segments is wound around a corresponding winding shaft; At least one of the retractable sections has a retracted state and a non-retracted state. In the non-retracted state, a radial cross-section of each of the retractable sections is substantially arc-shaped. In the retracted state, each of the retractable sections is relatively farther away from the push catheter in the radial direction of the push catheter than other portions of the sheath. The length of the winding section increases as the number of turns of the winding section increases; The control handle further comprises a cutting mechanism, wherein the cutting mechanism is used to cut the proximal end of the sheath in the axial direction when the winding mechanism winds the reeling section, so as to increase the length of the reeling section; The cutting mechanism includes a cutting base and a cutting blade disposed on the cutting base. The cutting base is provided with a through hole along the axial direction for the sheath to pass through. The cutting blade extends into the through hole. The cutting blade includes a cutting edge. The extending direction of the cutting edge intersects with the central axis of the sheath. The end of the cutting edge facing away from the cutting base is located between the outer wall of the pushing tube and the inner wall of the sheath.

2. The drug-coated balloon catheter according to claim 1, wherein: The winding mechanism includes a winding shaft, and the control handle also includes a power element fixedly connected to the winding shaft, and the power element is used to control the winding shaft to rotate to wind at least one of the winding segments.

3. The drug-coated balloon catheter according to claim 1, wherein: The winding mechanism includes at least two winding shafts, the sheath includes at least two winding sections, and the control handle also includes a driving mechanism arranged in the shell, and the driving mechanism is used to drive each winding shaft to rotate to wind the corresponding winding section; the central axis of each winding shaft is perpendicular to the central axis of the sheath.

4. The drug-coated balloon catheter according to claim 3, wherein: The driving mechanism includes at least two gears that are transmission-connected to at least two of the winding shafts, each of the gears includes a coaxially arranged gear portion and a rotating shaft portion, and each of the winding shafts is fixed on a corresponding rotating shaft portion and is coaxially arranged with the corresponding rotating shaft portion; one of the at least two gears serves as a driving gear, and the remaining gears serve as driven gears.

5. The drug-coated balloon catheter according to claim 4, wherein: At least two of the winding shafts include a first winding shaft and a second winding shaft, and at least two of the winding sections include a first winding section and a second winding section. The proximal end of the first winding section and the proximal end of the second winding section are respectively fixed on the first winding shaft and the second winding shaft. The first winding section is located on the end of the first winding shaft away from the gear part associated with the first winding shaft, and the second winding section is located on the end of the second winding shaft away from the gear part associated with the second winding shaft.

6. The drug-coated balloon catheter according to claim 5, wherein: The at least two gears include a first gear and a second gear meshing with the first gear, the first winding shaft and the second winding shaft are respectively fixed on the rotating shaft portion of the first gear and the rotating shaft portion of the second gear, the first gear or the second gear serves as the driving gear, and the winding direction of the first winding section is opposite to the winding direction of the second winding section.

7. The drug-coated balloon catheter according to claim 6, wherein: The at least two gears include a first gear, a second gear and a third gear that are meshed in sequence, and the first winding shaft and the second winding shaft are respectively fixed on the rotating shaft portion of the first gear and the rotating shaft portion of the third gear. When any one of the first gear, the second gear and the third gear is the driving gear, the winding direction of the first winding section is the same as the winding direction of the second winding section.

8. The drug-coated balloon catheter according to claim 5, wherein: The at least two gears include a first gear, a second gear and a third gear that are meshed in sequence; the first winding shaft and the second winding shaft are respectively fixed on the rotating shaft portion of the first gear and the rotating shaft portion of the second gear, the third gear serves as the driving gear, and the winding direction of the first winding section is opposite to the winding direction of the second winding section; or the first winding shaft and the second winding shaft are respectively fixed on the rotating shaft portion of the second gear and the rotating shaft portion of the third gear, the first gear serves as the driving gear, and the winding direction of the first winding section is opposite to the winding direction of the second winding section.

9. The drug-coated balloon catheter according to claim 5, wherein: The at least two gears include a first gear, a second gear, a third gear and a fourth gear that are meshed in sequence. The first winding shaft and the second winding shaft are respectively fixed on the rotating shaft portion of the first gear and the rotating shaft portion of the fourth gear. When the second gear or the third gear serves as the driving gear, the winding direction of the first winding section is opposite to the winding direction of the second winding section.

10. The drug-coated balloon catheter according to claim 9, wherein: The first gear and the fourth gear are symmetrically distributed about the central axis of the sleeve, the second gear and the third gear are symmetrically distributed about the central axis of the sleeve, and there is a distance between the first gear and the fourth gear.

11. The drug-coated balloon catheter according to claim 4, wherein: The control handle further comprises a power element fixedly connected to the driving gear, and the power element is used to control the driving gear to rotate so as to drive the driven gear and at least two winding shafts to rotate and wind at least two winding sections.

12. The drug-coated balloon catheter according to claim 4, wherein: The driving mechanism also includes a gear rack fixedly connected to the shell, and the at least two gears are rotatably connected to the gear rack. Each of the winding shafts includes an extended section extending from the gear rack, and each of the winding sections is wound on the extended section of the corresponding winding shaft.

13. The drug-coated balloon catheter according to claim 12, wherein: A limiting member is provided at one end of the extended section of each winding shaft away from the gear frame, and a limiting space is formed between the limiting member and the gear frame, so that each of the winding sections is located in the corresponding limiting space.

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