Detailed Description
The following description of the embodiments of the present application will be made clearly and completely with reference to the accompanying drawings, in which it is apparent that the embodiments described are only some embodiments of the present application, but not all embodiments. All other embodiments, which can be made by those skilled in the art based on the embodiments of the application without making any inventive effort, are intended to be within the scope of the application.
It should be noted that, in the interventional medical field, an end of the instrument close to the operator is generally referred to as a proximal end, and an end of the instrument remote from the operator is generally referred to as a distal end. The circumferential direction is the direction around the axis of the object such as a cylinder, a pipe body and the like (perpendicular to the axis and the radius of the section), and the radial direction is the direction along the diameter or the radius. It is noted that the terms "proximal," "distal," "one end," "other end," "first end," "second end," "initial end," "terminal," "both ends," "free end," "upper end," "lower end," and the like are intended to refer to "an end" and are not limited to a tip, endpoint, or end face, but include portions extending an axial distance and/or a radial distance from the tip, endpoint, or end face to the element to which the tip, endpoint, or end face pertains. Unless defined otherwise, all technical and scientific terms used herein have the same meaning as commonly understood by one of ordinary skill in the art to which this application belongs. The terminology used in the description of the application herein is for the purpose of describing particular embodiments only and is not intended to be limiting of the application. The terms first, second and the like in the description and in the claims and in the above-described figures, are used for distinguishing between different objects and not necessarily for describing a sequential or chronological order. The singular forms "a," "an," and "the" are intended to include the plural forms as well, unless the context clearly indicates otherwise. The term "comprising" and any variations thereof is intended to cover a non-exclusive inclusion. Furthermore, the present application may be embodied in many different forms and is not limited to the embodiments described in the present embodiment. The following specific examples are provided to facilitate a more thorough understanding of the present disclosure, in which terms indicating orientations of the components, up, down, left, right, etc., are merely for the locations of the illustrated structures in the corresponding drawings.
The description is then made of the preferred embodiments for carrying out the application, but the above description is made for the purpose of illustrating the general principles of the application and is not meant to limit the scope of the application. The scope of the application is defined by the appended claims.
Referring to fig. 1 to 3, a drug-coated balloon catheter 100 according to a first embodiment of the present application includes a push catheter 20, a drug-coated balloon 30 fixed at a distal end of the push catheter 20, a sheath 40 movably sleeved outside the push catheter 20 and the drug-coated balloon 30, and a control handle 50 disposed at a proximal end of the sheath 40.
The control handle 50 includes a housing 51 and a winding mechanism 53 disposed on the housing 51, the proximal end of the sheath 40 forming a winding section 401 connected to the winding mechanism 53, the winding mechanism 53 for winding the winding section 401 such that the distal end of the sheath 40 moves proximally to expose the drug coated balloon 30.
In the first state shown in fig. 1, the drug-coated balloon 30 of the drug-coated balloon catheter 100 is accommodated in the sheath 40, that is, in a state in which the drug-coated balloon 30 is not expanded, the sheath 40 protects the drug coating on the surface of the drug-coated balloon 30, and reduces the drug loss rate of the drug-coated balloon catheter 100 during the delivery process. In the second state shown in fig. 2, 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 vessel wall, and the drug effect is exerted.
Referring to fig. 3 to 8, the proximal end of the sheath 40 is divided into at least one winding section 401 along the axial direction of the sheath 40, that is, each winding section 401 includes two sides (not shown) extending along the axial direction of the sheath 40 and capable of being separated from each other, the push catheter 20 can pass through the winding section 401 from between the two sides, so that the winding mechanism 53 can wind only the winding section 401 without affecting the push catheter 20, and the winding mechanism 53 can smoothly wind the winding section 401. The winding mechanism 53 includes at least one winding shaft 530. In one embodiment, all the winding sections 401 are wound around the same said winding shaft 530. In other embodiments, each winding section 401 is wound around a respective winding shaft 530.
As shown in fig. 1 and 3-5, in this embodiment, the drug-coated balloon catheter 100 further includes a cutting mechanism 60 to rapidly cut the proximal end of the sheath 40 to form a rolled section 401. The cutting mechanism 60 is used to axially cut the proximal end of the sheath 40 as the winding mechanism 53 winds the spooled segment 401 to increase the length of the spooled segment 401. The cutting mechanism 60 may be secured directly to the housing 51 or may be secured to the housing 51 by other elements. The central axis of the cutting mechanism 60 is collinear with the central axis L1 of the sheath 40 to cut the proximal end of the sheath 40 into at least one rolled section 401 along the axial direction of the sheath 40.
The cutting mechanism 60 includes a cutting base 61 and a cutting blade 63 disposed on the cutting base 61. It will be appreciated that in other embodiments, the cutting mechanism 60 may include a plurality of cutting blades 63. The number of the cutting blades 63 corresponds to the number of the winding sections 401, and those skilled in the art can design the number of the cutting blades 63 according to actual needs, and the present application is not particularly limited.
Wherein, the cutting base 61 is provided with a through hole 610 along the axial direction for the sheath 40 to pass through. Cutting blade 63 extends into through hole 610 and cutting blade 63 includes a cutting edge 631. The extension direction of the cutting edge 631 intersects the central axis L1 of the sheath 40, i.e. the extension direction of the cutting edge 631 forms an angle α with the central axis L1 of the sheath 40, wherein preferably 90 ° or more α or more than 15 °. The distal end of the cutting base 61 is provided with a clamping groove 611 communicated with the through hole 610. The cutting blade 63 is clamped in the clamping groove 611 and extends into the through hole 610. Alternatively, in some embodiments, the cutting edge 631 is perpendicular to the axial direction of the sheath 40, i.e., the extending direction of the cutting edge 631 is perpendicular to the central axis L1 of the sheath 40.
Wherein 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 avoid snagging on the push catheter 20 when the cutting blade 63 cuts the sheath 40. To ensure smoothness of the cutting 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 may be smaller than that of the cutting blade 63 to save costs. In the present embodiment, the cutting blade 63 is made of stainless steel 440C, and the cutting base 61 is made of stainless steel 304. In other embodiments, cutting blade 63 may be replaced with other cutting elements such as wire.
In some alternative embodiments, the drug-coated balloon catheter 100 may omit the cutting mechanism 60, which may simplify the structure of the drug-coated balloon catheter 100 and reduce production costs. To facilitate severing of the proximal end of the sheath 40, the proximal end of the sheath 40 is provided with at least one axially extending auxiliary severing feature 403. The auxiliary dividing structure 403 includes, but is not limited to, at least one of crease, a plurality of hollow slits arranged at intervals, and a thinning groove. Pulling on both sides of the auxiliary dividing structure 403 divides the proximal end of the sheath 40 via the auxiliary dividing structure 403 to form the rolled section 401. It will be appreciated 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 sectioning structure 403 to further rapidly cut the proximal end of the sheath 40.
Wherein the distal end of sheath 40 is movable in the axial direction of push catheter 20. Sheath 40 is preferably a tubular structure that may be placed over the exterior of unexpanded drug coated balloon 30. Sheath 40 is made of a biocompatible material. The biocompatible material is, for example, but not limited to, e-PTFE, PTFE, FEP, or a material with a low coefficient of friction such as PET. Preferably, to facilitate sliding of the distal end of the sheath 40 along the axial direction of the push catheter 20, the sheath 40 is made of a material having a relatively low coefficient of friction.
Optionally, to facilitate the extension of the drug-coated balloon 30 from within the sheath 40, the distal end of the sheath 40 may also be provided with at least one axially extending auxiliary dividing structure 403. Specifically, after the drug-coated balloon 30 is delivered to the lesion, the sheath 40 is retracted, that is, the winding mechanism 53 winds the winding section 401, so that the distal end of the sheath 40 moves in the proximal direction near the push catheter 20, the distal auxiliary dividing structure 403 may be spread apart by the drug-coated balloon 30 until it is torn, and the proximal auxiliary dividing structure 403 may be cut by the cutting mechanism 60 or torn by the winding force transmitted through the winding shaft 530, so that the drug-coated balloon 30 may protrude from the side of the sheath 40 near the distal end and be exposed to the outside of the sheath 40, thereby realizing the exposure of the drug-coated balloon 30 to the vascular environment of the lesion, and then the drug-coated balloon 30 is inflated and expanded, so that the drug coating is released and transferred to the vascular inner wall of the lesion.
As shown in fig. 3 and 6 to 8, the roll-up section 401 has a roll-up state and a non-roll-up state. The jacket 40 also includes a non-rolled section 402 adjacent to the rolled section. The radial cross-section of the winding section 401 is an open loop configuration to facilitate winding of the winding section 401 off of the push catheter 20 on the winding shaft 530. The radial cross section of the non-furling section 402 is a closed loop structure to avoid drug loss caused by the drug-coated balloon 30 being flushed by high-speed blood flow, thereby greatly reducing the rate of drug loss during delivery of the drug-coated balloon catheter 100. Since the sheath 40 is of hollow tubular construction, in the non-rolled state, each rolled section 401 has a substantially arcuate radial cross-section. In the rolled state, each rolled section 401 is relatively far from the pusher catheter 20 in the radial direction of the pusher catheter 20 compared to the other portions of the sheath 40 (i.e., the non-rolled sections 402), which facilitates the separation of the proximal end of the sheath 40, increases the axial length of the rolled sections 401, and avoids interference with the pusher catheter 20 when the rolling mechanism 53 rolls the rolled sections 401 of the sheath 40.
Specifically, the line L2 of the rolled section 401 when rolled deviates from the central axis L1 of the non-rolled section 402, i.e. the rolled section 401 deviates from the non-rolled section 402, i.e. an angle β is formed between the rolled section 401 and the non-rolled section 402. Optionally, the included angle β is acute, so as to avoid the problem of sheath breakage caused by excessive deviation of the winding section 401, and so that the winding section 401 does not interfere with the push catheter 20 when wound on the winding shaft 530.
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 rolled section 401 along the axial direction of the sheath 40. The radial cross section of the winding section 401 is substantially C-shaped. Specifically, the proximal end of sheath 40 is cut with an opening 4011 axially to form a crimp segment 401 to effect a rotation of the crimp segment 401 about the winding axis 530 offset from the pusher catheter 20. The distal end of the winding section 401 is fixedly connected to the non-winding section 402, and the proximal end of the winding section 401 is fixed to the winding shaft 530.
Referring again to fig. 1 and 3, the control handle 50 further includes a power element 55 fixedly coupled to the winding shaft 530. The power element 55 is used to control the rotation of the winding shaft 530 to wind the winding section 401. In other embodiments, the proximal end of the sheath is split into at least two furling segments along the axial direction of the sheath, and the at least two furling segments are both wound on a winding shaft. The power element is used for controlling the winding shaft to rotate so as to wind at least two winding sections.
The power element 55 may be 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 connection 551 fixed to the winding shaft 530 and an operation portion 552 fixed to a side of the connection 551 facing away from the winding shaft 530. The connection portion 551 extends vertically from the middle of the operation portion 552. The connection portion 551 and the winding shaft 530 may be integrally formed, or may be fixedly connected together by a mounting structure. Such as, but not limited to, a snap-fit arrangement, a threaded arrangement, etc. The operation portion 552 is exposed to the housing 51 and rotatable relative to the housing 51 for operation by a user. Specifically, when the operation portion 552 rotates in the first preset direction, the winding section 401 rotates around the central axis of the winding shaft 530 to move the distal end of the sheath 40 toward the proximal end of the sheath 40, thereby realizing the protrusion of the drug coated balloon 30 from the inside of the sheath 40. The first preset direction may be a clockwise direction or a counterclockwise direction.
The drug-coated balloon catheter also includes a catheter hub 10. Catheter hub 10 is disposed at the proximal end of push catheter 20. Catheter hub 10 may be secured directly to push catheter 20 or may be secured to push catheter 20 by control handle 50. Catheter hub 10 is provided with a guidewire port 11 for guidewire penetration and an inflation port 13 for fluid infusion of the inflation balloon.
The control handle 50 also includes a buffer sleeve 54 fixedly disposed on the distal end of the housing 51. The central axis of the buffer cannula 54 is collinear with the central axis L1 of the push catheter 20 and sheath 40. The push catheter 20 and sheath 40 are disposed through the buffer cannula 54 so that kinking of the push catheter 20 and sheath 40 is avoided. The cushion collar 54 may be injection molded from a soft gel material such as, but not limited to, silicone, thermoplastic polyurethane elastomer, and the like.
Specifically, the housing 51 includes a first housing 511 and a second housing 512 that are fixed to each other. The first housing 511 and the second housing 512 may be fixedly connected together by a fastening structure, a screw locking mechanism, or the like. Both the first housing 511 and the second housing 512 may be made of hard plastic materials to save cost. The hard material includes, but is not limited to, acrylonitrile-butadiene-styrene plastic (Acrylonitrile Butadiene STYRENE PLASTIC, ABS). The first housing 511 and the second housing 512 enclose a cavity 510 (see fig. 9) having two opposite through holes 5101,5102. The buffer sleeve 54 is clamped in the through hole 5101, the catheter holder 10 is clamped in the through hole 5102, and the pushing catheter passes through the buffer sleeve 54 and is connected with the catheter holder 10. The first housing 511 is further provided with a clearance opening 5111 through which the operation portion 552 of the power element 55 passes, so as to facilitate the operation of a user. The cutter mechanism 60 and the winding mechanism 53 are both housed in the cavity 510 of the housing 51.
The interior of the push catheter 20 is axially provided with a guidewire lumen and a filling lumen. The guidewire lumen is isolated from the filling lumen and disposed 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 formed through the drug-coated balloon 30. The guidewire port 11 is in communication with the guidewire lumen to enable a guidewire to pass through the guidewire port 11 and through the guidewire lumen. The guidewire lumen extends axially through the distal and proximal ends of the push catheter 20. The filling cavity is communicated with the filling port 13 and the balloon filling port. Thus, the inflation port 13, inflation lumen and balloon inflation port form a channel for inflating or depressurizing the drug-coated balloon 30 to effect the inflation or deflation of the drug-coated balloon 30 by the introduction or withdrawal of fluid into or from the drug-coated balloon 30. Specifically, the filling port 13 may be connected to an external pressure pump, and the liquid enters or exits the interior of the drug-coated balloon 30 through the filling port 13, the filling cavity, and the balloon filling port, so as to realize filling expansion or pressure release of the drug-coated balloon 30. It will be appreciated that the user may provide one or more filling lumens within the push catheter 20 depending on the actual condition of the lesion and the time required for filling, and that one or more filling ports 13 may be provided on the catheter hub 10 accordingly.
The distal end of the push catheter 20 is fixedly provided with at least one drug-coated balloon 30. The fixing manner of the drug coated balloon 30 may be welding, bonding or fixing by a fixing member, which are common in the art, and will not be described herein.
Wherein the drug-coated balloon 30 is an expandable balloon. Specifically, the interior of the drug-coated balloon 30 may be selectively filled or drained, thereby improving the adherence of the drug-coated balloon 30. The outer wall of the drug-coated balloon 30 is provided with a drug coating. The drug coating may cover the entire outer wall of the drug coating balloon 30. In another embodiment, the drug coating may cover a portion of the outer wall of the drug coating balloon 30. In one embodiment, the active agent coating comprises an active agent that inhibits smooth muscle cell proliferation. Optionally, in another alternative embodiment, a carrier is also included in the drug coating. The carrier may be used to facilitate rapid release of the active agent from the outer wall of the drug coated balloon 30 or to facilitate absorption by the diseased tissue. The carrier is, for example, but not limited to, an organic acid salt or a polyol, and mannitol is used as the carrier in this embodiment. In this embodiment, the active drug is a drug (e.g., paclitaxel, rapamycin, etc.) having an inhibitory effect on smooth muscle cell proliferation, and paclitaxel is used in this embodiment.
The procedure for treating a lesion of a blood vessel using the drug-coated balloon catheter 100 provided in the first embodiment of the present application includes the operations of first delivering the distal end portion of the drug-coated balloon catheter 100 to the vicinity of the lesion of the blood vessel and aligning the drug-coated balloon 30 to the lesion. The winding mechanism 53 is controlled to wind the winding section 401 so that the distal end of the sheath 40 moves proximally, namely, the distal end of the sheath 40 moves in the axial direction of the push catheter 20 towards the direction close to the proximal end of the push catheter 20 until the drug coated balloon 30 is exposed outside the sheath 40, at this time, the drug coated balloon 30 is exposed at the lesion site of the blood vessel, the drug coated balloon 30 is inflated, the blood vessel at the lesion site is fully expanded after the drug coated balloon 30 is inflated, the drug coated 32 is released from the surface of the drug coated balloon 30 and transferred to the blood vessel wall to exert the drug effect, and finally the drug coated balloon 30 is decompressed, withdrawn from the body of the patient, and the operation is completed.
According to the drug coated balloon catheter 100 provided by the embodiment of the application, the sheath 40 is sleeved outside the drug coated balloon 30, the winding mechanism 53 is arranged on the control handle 50, the proximal end of the sheath 40 forms the winding section 401 connected with the winding mechanism 53, and the winding section 401 is wound by the winding mechanism 53, so that the distal end of the sheath 40 moves towards the proximal end, and the drug coated balloon 30 is exposed. Therefore, the sheath 40 can protect the drug coating on the surface of the drug coating balloon 30, so that the drug loss rate of the drug coating balloon catheter in the conveying process is reduced, more importantly, as the winding mechanism 53 on the control handle 50 controls the distal end of the sheath 40 to move towards the proximal end in a winding manner, compared with the control manner of stretching through a pipe fitting in the prior art, the length of the control handle can be obviously shortened, the operation of doctors is greatly facilitated, in addition, the winding degree of the winding mechanism 53 on the winding section 401 can correspondingly expose the balloons with different lengths, the balloons with different lengths can be matched with the same control handle, the application range of the control handle is enlarged, and purchasing and inventory management are also facilitated.
Referring to fig. 9 and 10 together, the structure of the drug-coated balloon catheter 200 according to the second embodiment of the present application is similar to that of the drug-coated balloon catheter 100 according to the first embodiment, except that the winding mechanism 53 includes at least two winding shafts 530, the sheath 40 includes at least two winding sections 401, and the control handle 50 further includes a driving mechanism 57 disposed in the housing 51, and the driving mechanism 57 is used for driving each winding shaft 530 to rotate so as to wind the corresponding winding section 401. The central axis of each winding shaft 530 is perpendicular to the central axis of the sheath 40.
The drive mechanism 57 comprises at least two gears 570 drivingly connected to at least two of said winding shafts 530, each gear 570 comprising a coaxially arranged gear portion 5701 and a shaft portion 5702. Each winding shaft 530 is fixed to a corresponding rotating shaft portion 5702, and is disposed coaxially with the corresponding rotating shaft portion 5702. One of the at least two gears 570 acts as a driving gear and the remaining gears 570 act as driven gears.
In the present 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 winding sections 401 include a first winding section 41 and a second winding section 42. The proximal ends of the first winding section 41 and the second winding section 42 are respectively fixed to the first winding shaft 531 and the second winding shaft 532, the first winding section 41 is located on an end of the first winding shaft 531 away from the gear portion 5701 associated with the first winding shaft 531, and the second winding section 42 is located on an end of the second winding shaft 532 away from the gear portion 5701 associated with the second winding shaft 532.
The at least two gears 570 include a first gear 571, a second gear 572, a third gear 573, and a fourth gear 574 that are sequentially engaged. The first winding shaft 531 and the second winding shaft 532 are fixed to the rotation shaft portion 5702 of the first gear 571 and the rotation shaft portion 5702 of the fourth gear 574, respectively. When the second gear 572 or the third gear 573 is used as the driving gear, the winding direction of the first winding section 41 is opposite to the winding direction of the second winding section 42. In this way, the first winding shaft 531 and the second winding shaft 532 can wind the first winding section 41 and the second winding section 42, respectively, improving the reliability of winding the proximal end of the sheath 40.
Specifically, in the present embodiment, the first winding shaft 531 is integrally formed with the rotation shaft portion 5702 of the first gear 571, and the second winding shaft 532 is integrally formed with the rotation shaft portion 5702 of the fourth gear 574, that is, the rotation shaft portion 5702 of the first gear 571 may be used as the first winding shaft 531, and the rotation shaft portion 5702 of the fourth gear 574 may be used 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 may be welded together or detachably fixedly connected 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 be rotated synchronously, thereby ensuring smoothness and balance of the proximal winding of the sheath 40.
The first winding section 41 and the second winding section 42 may be fixed to the outer wall or the inner wall of the first winding shaft 531 and the second winding shaft 532, respectively, by an adhesive method. In the present embodiment, the first winding shaft 531 and the second winding shaft 532 are both provided with a through hole 5301, the proximal end of the first winding section 41 passes through the through hole 5301 of the first winding shaft 531 and is tightly wound around the outer wall of the first winding shaft 531 for a preset number of turns, and the proximal end of the second winding section 42 also passes through the through hole 5301 of the second winding shaft 532 and is tightly wound around the second winding shaft 532 for a preset number of turns. Wherein the preset number of turns is 3-4. In other embodiments, the first winding section 41 and the second winding section 42 may be fixed to the first winding shaft 531 and the second winding shaft 532 by bonding, crimping, buckling, screw locking, etc.
Referring to fig. 9 to 11 again, in the present embodiment, the second gear 572 serves as a driving gear, the first gear 571, the third gear 573, and the fourth gear 574 serve as driven gears, and the third gear 573 serves as a driven reversing gear. When the second gear 572 rotates in a first direction, the first and third gears 571 and 573 are driven to rotate in a second direction opposite to the first direction, and the fourth gear 574 rotates in the first direction. At this time, the first gear 571 and the fourth gear 574 drive the corresponding first winding shaft 531 and second winding shaft 532 to rotate synchronously, respectively, but the first winding shaft 531 and the second winding shaft 532 rotate in opposite directions, the winding direction of the first winding section 41 is adapted to the rotation direction of the first winding shaft 531, and the winding direction of the second winding section 42 is adapted to the rotation direction of the second winding shaft 532, so that the first winding shaft 531 and the second winding shaft 532 continuously wind the corresponding first winding section 41 and second winding section 42 in opposite directions, respectively. In this manner, the distal end of sheath 40 is moved proximally to expose the drug-coated balloon. The winding direction of the first winding section 41 is opposite to the winding direction of the second winding section 42, which helps the distal ends of the first winding section 41 and the second winding section 4 to be continuously separated or separated by the pulling action of the first winding shaft 531 and the second winding shaft 532.
Optionally, the first gear 571 and the fourth gear 574 are symmetrically distributed about the central axis of the sheath 40, the second gear 572 and the third gear 573 are symmetrically distributed about the central axis of the sheath 40, and a space is provided between the first gear 571 and the fourth gear 574. In this way, the winding space of the first winding shaft 531 and the second winding shaft 532 is increased, interference is avoided during the process of winding the first winding section 41 and the second winding section 42 by the first winding shaft 531 and the second winding shaft 532 respectively, and smoothness and balance of winding action are further improved.
Wherein, in order 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 high polymer material includes, but is not limited to, polyoxymethylene resin (Polyoxymethylene, POM) and nylon. The metallic material includes, but is not limited to, stainless steel.
Optionally, the control handle 50 further comprises a power element 55 fixedly connected to said drive gear. The power element 55 is used for controlling the rotation of the driving gear to drive the rotation of the driven gear and the at least two winding shafts 530 to wind the at least two winding sections 401. The power element in the first embodiment is applicable to the power element 55 in the second embodiment, and the disclosure is not repeated. In a second embodiment, the power element 55 is fixedly connected to the drive gear.
In this embodiment, the control handle 50 further includes a gear rack 52 fixedly connected to the housing 51. At least two gears 570 are rotatably coupled to the carrier 52. Each winding shaft 530 includes an extension 5301 extending from the gear frame 52, and each winding section 401 is wound on the extension 5301 of the corresponding winding shaft 530.
Specifically, the gear rack 52 includes a first bracket 521 and a second bracket 522 that are fixed in cooperation with each other. The first bracket 521 and the second bracket 522 are detachably coupled together to facilitate the user's installation and removal of the roll-up section 401. The first bracket 521 and the second bracket 522 together enclose a receiving space 523 that receives at least two gears 570. The second bracket 522 has a plate-like structure. The distal end of the second bracket 522 is provided with an extension plate 5221 for securing the cutting mechanism 60. The cutting mechanism 60 is disposed on the side of the extension plate 5221 facing away from the first bracket 521, and prevents the winding section 401 from interfering with the rotation of the corresponding two gears 370 when wound on the winding shaft 530.
Each of the rolled sections 401 is deviated from the non-rolled section 402 toward the central axis L1 away from the sheath 40, i.e. the extending direction of each rolled section 401 forms an angle β with the axial direction of the sheath 40. Optionally, the included angle β is an acute angle, so as to avoid the problem that the winding section 401 deviates in transition and causes breakage. In this way, by designing the extension plate 5221 to expose the first bracket 521, more space is provided below the gear frame 52 to accommodate the rolled-up section 401, thereby further ensuring that the rolling mechanism 53 does not interfere with the pushing catheter 20 when rolling up the rolled-up section 401 of the sheath 40.
Optionally, an end of the protruding section 5301 of each winding shaft 530 remote from the gear frame 52 is provided with a stopper 58. A spacing space 580 is formed between the spacing member 58 and the gear frame 52 such that each of the winding segments 401 is positioned within the corresponding spacing space 580, thereby preventing each of the winding segments 401 from being separated from the corresponding winding shaft 530, and further ensuring the reliability of winding the winding segments 401 on the winding shaft 530 such that the distal end of the sheath 40 moves in the axial direction of the push catheter 20 such that the drug-coated balloon 30 can extend out of the sheath 40.
Referring again to fig. 9 and 10, the drive mechanism 57 further includes a plurality of bushings 5703 secured to the carrier 52. Both ends of each gear 570 are rotatably coupled to the associated two shaft sleeves 5703, thus reducing friction between the gears 570 and the gear frame 52, and improving smoothness of winding of the winding section 401 of the sheathing 40. It will be appreciated that the length of the winding section 401 increases with the number of turns of the winding section.
Referring to fig. 9 and 12-13, fig. 12 is a schematic structural view of the cutting mechanism 60 of the drug coated balloon catheter 200, and fig. 13 is a sectional view of the cutting mechanism 60 of the drug coated balloon catheter 200, the sheath 40 and the pusher catheter 20 along the axial direction of the sheath. 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 a cutting base 61 of the cutting mechanism 60.
The two cutting blades 63 are symmetrically distributed about the central axis L1 of the sheath 40, so that the proximal end of the sheath 40 near the cutting blade 63 can obtain the winding section 401 with the same size after cutting, thereby ensuring the winding balance of the winding 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 less than about 2mm-5mm of the inner diameter of the sheath 40 and greater than about 2mm-5mm of the outer diameter of the push catheter 20. In this way, the cutting blade 63 is prevented from snagging the push catheter 20 while cutting the sheath 40.
The balloon catheter with the drug coating provided by the embodiment can obviously shorten the length of the control handle based on the same principle as the embodiment, is convenient for doctors to operate, and the balloons with different lengths can be matched with the same control handle, so that the application range of the control handle is enlarged, and purchasing and inventory management are also convenient, and are not repeated here. In addition, four gears in transmission connection with the winding mechanism are arranged in the control handle of the embodiment, so that the winding smoothness and balance of the two winding sections are improved.
Referring to fig. 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 which are sequentially meshed, 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 third gear 573, and when any one of the first gear 571, the second gear 572 and the third gear 573 can be used 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. In this way, the distance between the first winding shaft 531 and the second winding shaft 532 is increased, and further the first winding section 41 and the second winding section 42 can be wound relatively far from each other without interfering with each other.
For example, when the second gear 572 is rotated in the counterclockwise direction D1 as the driving gear, the first gear 571 and the third gear 573 are driven to rotate in the clockwise direction D2, and at this time, the first winding section 41 and the second winding section 42 respectively fixed on the first winding shaft 531 and the second winding shaft 532 are pulled, that is, the first winding section 41 and the second winding section 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 toward the proximal end close to the push catheter 20 in the axial direction, thereby exposing the drug coated balloon 30.
In other embodiments, the first winding shaft 531 and the second winding shaft 532 are respectively fixed on the rotating shaft portion of the second gear 572 and the rotating shaft portion of the third gear 573, and 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. Or the first winding shaft 531 and the second winding shaft 532 are respectively fixed to the rotating shaft portion of the first gear 571 and the rotating shaft portion of the second gear 572, and 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.
The balloon catheter with the drug coating provided by the embodiment can obviously shorten the length of the control handle based on the same principle as the embodiment, is convenient for doctors to operate, and the balloons with different lengths can be matched with the same control handle, so that the application range of the control handle is enlarged, and purchasing and inventory management are also convenient, and are not repeated here. In addition, be provided with three gears that are connected with winding mechanism transmission in the control handle, three gears set up side by side in proper order along the direction of perpendicular to sheath central axis, help further reducing control handle's length for control handle's overall dimension is littleer.
Referring to fig. 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 meshed with the first gear 571, 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, the first gear 571 or the second gear 572 can be used 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.
When the first gear 571 rotates in the counterclockwise direction D1, the second gear 572 is driven to rotate in the clockwise direction D2, and at this time, the first winding section 41 and the second winding section 42 respectively fixed on the first winding shaft 531 and the second winding shaft 532 are pulled, that is, the first winding section 41 winds around the first winding shaft 531 in the counterclockwise direction D1, and the second winding section 42 winds around the second winding shaft 532 in the clockwise direction D2, so that the distal end of the sheath 40 moves toward the proximal end near the push catheter 20 in the axial direction, thereby exposing the drug coated balloon 30.
The balloon catheter with the drug coating provided by the embodiment can obviously shorten the length of the control handle based on the same principle as the embodiment, is convenient for doctors to operate, and the balloons with different lengths can be matched with the same control handle, so that the application range of the control handle is enlarged, and purchasing and inventory management are also convenient, and are not repeated here. In addition, be provided with two gears of being connected with winding mechanism transmission in the control handle, two gears set up side by side along the direction of perpendicular to sheath central axis, have not only promoted the coiling smoothness nature and the equilibrium of two roll-up sections, and help further reducing control handle's length to make control handle's overall dimension littleer.
The foregoing has outlined rather broadly the more detailed description of embodiments of the application, wherein the principles and embodiments of the application are explained in detail using specific examples, the above examples being provided solely to facilitate the understanding of the method and core concepts of the application; meanwhile, as those skilled in the art will appreciate, modifications will be made in the specific embodiments and application scope in accordance with the idea of the present application, and the present disclosure should not be construed as limiting the present application.