CN115607812A - Drug-coated balloon catheter - Google Patents

Abstract

The application discloses medicine coating sacculus pipe, including the propelling movement pipe, be fixed in the medicine coating sacculus, the activity cover of the distal end of propelling movement pipe are established the propelling movement pipe reaches the outer sheath of medicine coating sacculus and set up in the brake valve lever of sheath near-end. The control handle comprises a shell and a winding mechanism arranged on the shell, a winding section connected with the winding mechanism is formed at the proximal end of the sheath, and the winding mechanism is used for winding the winding section so that the distal end of the sheath moves towards the proximal end to expose the drug coating balloon. The drug coating balloon catheter can obviously shorten the length of the control handle, and is convenient for doctors to operate; in addition, the saccules with different lengths can be matched with the same control handle, so that the application range of the control handle is enlarged, and the purchase and the inventory management are convenient.

Description

Drug-coated balloon catheter

Technical Field

The application relates to the technical field of medical equipment, in particular to a drug coating balloon catheter.

Background

Arterial stenosis has been a disease which troubles human beings, and in order to cure the disease, human beings go through treatment stages of a naked balloon, a naked stent, a drug eluting stent and the like in sequence, however, the treatment schemes have different defects. The drug-coated balloon catheter is produced by carrying out the operation, a channel is established for blood circulation through balloon expansion, and drugs carried on the balloon can effectively inhibit proliferation of smooth muscle cells and prevent restenosis of blood vessels.

In the traditional medicine coating balloon catheter, before the medicine coating balloon is expanded, an active medicine coating arranged on the surface of the medicine coating balloon is exposed in a blood vessel environment, so that the medicine coating is easily washed by high-speed blood flow to cause the loss of medicine dosage. An existing drug-coated balloon catheter reduces the loss rate of drugs by providing a sheath on the outside of the drug-coated balloon.

This current medicine coating sacculus pipe sets up the near end of sheath and slider fixed connection on the control handle together, and the telescopic pipe fitting that sets up along the axial is connected to the slider, when operation slider moves to the near end along the axial, the pipe fitting intussuscepts to the near end along the axial, and the sheath is being driven by the slider and is moving to the near end simultaneously, exposes the sacculus that scribbles the medicine to release the medicine. However, the above-mentioned existing drug-coated balloon catheters have the following drawbacks: along with the increase of the length of the saccule, the axial moving distance of the sliding block and the length of the pipe fitting must be increased, so that the length of the control handle is increased (the length of the control handle can reach more than 35 cm), the use of an operator is inconvenient, and a longer guide wire needs to be matched; in addition, the balloons with different lengths need to be matched with control handles with different models, the application range of the control handles is limited, and the purchase and inventory management are inconvenient due to too many models of the control handles.

Disclosure of Invention

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

The embodiment of the application provides a medicine coating sacculus pipe, include the propelling movement pipe and be fixed in the medicine coating sacculus of the distal end of propelling movement pipe, medicine coating sacculus pipe is still established including the activity cover the propelling movement pipe reaches the outer sheath of medicine coating sacculus and set up in the brake valve lever of sheath proximal end, brake valve lever include the shell and set up in winding mechanism on the shell, the proximal end of sheath form with the roll-up section that winding mechanism connects, winding mechanism is used for coiling the roll-up section, so that the distal end of sheath removes to the proximal end, thereby exposes the medicine coating sacculus.

The drug coating balloon catheter provided by the embodiment of the application is provided with the sheath outside the drug coating balloon, the winding mechanism is arranged on the control handle, the winding section connected with the winding mechanism is formed at the near end of the sheath, and the winding section is wound through the winding mechanism, so that the far end of the sheath moves towards the near end to expose the drug coating balloon. Therefore, the sheath can protect the drug coating on the surface of the drug coating balloon, and the drug loss rate of the drug coating balloon catheter in the conveying process is reduced; more importantly, the winding mechanism on the control handle controls the far end of the sheath to move towards the near end in a winding mode, so that compared with the control mode of extending and retracting through a pipe fitting in the prior art, the length of the control handle can be obviously shortened, and the doctor can operate the control handle conveniently; in addition, the winding mechanism can correspondingly expose the balloons with different lengths according to different winding degrees of the winding section, so that the balloons with different lengths can be matched with the same control handle, the application range of the control handle is expanded, and the purchasing and inventory management are also facilitated.

Drawings

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

Fig. 1 is a schematic structural view of a drug-coated balloon catheter provided in a first embodiment of the present application in a first state.

Fig. 2 is a schematic structural view of the drug-coated balloon catheter of fig. 1 in a second state.

Fig. 3 is a diagrammatic illustration of the winding mechanism of the drug-coated balloon catheter of fig. 2 winding the furled section of the sheath.

Fig. 4 is a schematic structural view of a cutting mechanism of the drug-coated balloon catheter of fig. 3.

Fig. 5 is a schematic cross-sectional view of the cutting mechanism and sheath of the drug-coated balloon catheter and the pusher catheter of fig. 3 along the axial direction of the sheath.

Fig. 6 is a schematic radial cross-sectional view of the take-up section and take-up shaft of the drug-coated balloon catheter of fig. 3.

Fig. 7 is a schematic radial cross-sectional view of the sheath and cutting blades of the drug-coated balloon catheter of fig. 3.

Fig. 8 is a schematic radial cross-sectional view of the furled section of the drug-coated balloon catheter of fig. 3 in a non-furled state.

Fig. 9 is a schematic structural view of a drug-coated balloon catheter provided in a second embodiment of the present application.

Fig. 10 is an exploded perspective view of the gear carrier, winding mechanism, and drive mechanism of the drug-coated balloon catheter of fig. 9.

Fig. 11 is a diagrammatic illustration of the winding mechanism of the drug-coated balloon catheter of fig. 9 retracting the retraction segment of the sheath.

Fig. 12 is a schematic view of the cutting mechanism of the drug-coated balloon catheter of fig. 9.

Fig. 13 is a cross-sectional view of the cutting mechanism and sheath and pusher catheter of the drug-coated balloon catheter of fig. 9 along the axial direction of the sheath.

Fig. 14 is a diagrammatic, schematic view of a drug-coated balloon catheter provided in accordance with a third embodiment of the present application.

Fig. 15 is a schematic structural diagram of a drug-coated balloon catheter provided in a fourth embodiment of the present application.

Description of the main elements

Drug- coated balloon catheter 100, 200, 300, 400

Catheter hub 10

Pusher catheter 20

Drug-coated balloon 30

Sheath 40

Roll-up section 401

Non-furled section 402

The first winding section 41

Second retraction segment 42

Auxiliary segmentation structure 403

Control handle 50

Outer shell 51

Through holes 5101 and 5102

Cavity 510

First housing 511

Avoiding position port 5111

Second shell 512

Gear carrier 52

First bracket 521

Second bracket 522

Extension plate 5221

Receiving space 523

Winding mechanism 53

Winding shaft 530

First winding shaft 531

Second winding shaft 532

Buffer tube 54

Power element 55

Connecting part 551

Operation unit 552

Drive mechanism 57

Gear 570

Gear part 5701

Rotating shaft part 5702

Shaft sleeve 5703

First gear 571

Second gear 572

Third gear 573

Fourth Gear 574

Position limiter 58

Spacing space 580

Cutting mechanism 60

Cutting base 61

Through hole 610

Card slot 611

Cutting blade 63

Cutting edge 631

The following detailed description will further illustrate the present application in conjunction with the above-described figures.

Detailed Description

The technical solutions in the embodiments of the present application will be clearly and completely described below with reference to the drawings in the embodiments of the present application, and it is obvious that the described embodiments are only some embodiments of the present application, and not all embodiments. All other embodiments, which can be derived by a person skilled in the art from the embodiments given herein without making any creative effort, shall fall within the protection scope of the present application.

First, in the field of interventional medicine, the end of the instrument near the operator is generally referred to as the proximal end, and the end of the instrument 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 column, a pipe body and the like (perpendicular to the axis and the radius of the section); radial is the direction along a diameter or radius. It is noted that the term "end" as used herein with respect to "proximal end", "distal end", "one end", "another end", "first end", "second end", "initial end", "distal end", "both ends", "free end", "upper end", "lower end", and the like, is not limited to a tip, end or end surface, but also includes a portion extending an axial distance and/or a radial distance from the tip, end or end surface over the component to which the tip, end or end surface 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 invention 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 claims of the present application and in the above-described drawings are used for distinguishing between different objects and not for describing a particular 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 "comprises" and any variations thereof is intended to cover non-exclusive inclusions. In addition, the present application may be embodied in many different forms and is not limited to the embodiments described in the present embodiment. The following detailed description is provided for the purpose of providing a more thorough understanding of the present disclosure, and the words used to indicate orientation above, below, left and right are used solely to describe the illustrated structure in the context of the corresponding figures.

While the specification concludes with claims describing the preferred embodiments of the present application, it is understood that the description is made only by way of illustration of the general principles of the present application and not intended to limit the scope of the present application. The protection scope of the present application shall be subject to the definitions of the appended claims.

Referring to fig. 1 to 3, a balloon catheter 100 with drug coating according to a first embodiment of the present disclosure includes a push catheter 20, a balloon 30 with drug coating fixed at a distal end of the push catheter 20, a sheath 40 movably sleeved on the push catheter 20 and the balloon 30 with drug coating, and a control handle 50 disposed at a proximal end of the sheath 40.

Control handle 50 includes a housing 51 and a winding mechanism 53 disposed on housing 51. The proximal end of sheath 40 forms a winding segment 401 connected to winding mechanism 53. Winding mechanism 53 is used to wind winding segment 401 such that the distal end of sheath 40 moves proximally to expose 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, the drug-coated balloon 30 is not expanded, and the sheath 40 protects the drug coating on the surface of the drug-coated balloon 30, thereby reducing 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 out of 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 the drug effect.

Referring to fig. 3 to 8, the proximal end of the sheath 40 is divided into at least one furling section 401 along the axial direction of the sheath 40, that is, each furling section 401 includes two side edges (not labeled) that can be away from each other and extend along the axial direction of the sheath 40, the push catheter 20 can pass out of the furling section 401 from between the two side edges, so that the winding mechanism 53 can wind only the furling section 401 without affecting the push catheter 20, and the winding mechanism 53 can smoothly wind the furling section 401. The winding mechanism 53 includes at least one winding shaft 530. In an embodiment, all the roll-up segments 401 are wound around the same said winding shaft 530. In other embodiments, each take-up segment 401 is wound about 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 furled segment 401. The cutting mechanism 60 is used to cut the proximal end of the sheath 40 axially when the winding mechanism 53 winds said furled section 401, so that the length of the furled section 401 increases. The cutting mechanism 60 may be secured directly to the housing 51; or may be secured to the housing 51 by other means. 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 into at least one furled segment 401 in 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 furling sections 401, and those skilled in the art can design the number of the cutting blades 63 according to actual requirements, and the present application is not limited in particular.

The cutting base 61 is provided with a through hole 610 for the sheath 40 to pass through in the axial direction. Cutting blade 63 extends into through-hole 610 and cutting blade 63 includes cutting edge 631. The extending direction of the cutting edge 631 intersects the central axis L1 of the sheath 40, i.e. the extending direction of the cutting edge 631 forms an included angle α with the central axis L1 of the sheath 40, wherein preferably 90 ° α ≧ 15 °. The distal end of the cutting base 61 is provided with a slot 611 penetrating the through hole 610. The cutting blade 63 is clamped in the clamping groove 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, i.e. the cutting edge 631 extends 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 conduit 20 and the inner wall of the sheath 40 to avoid the cutting blade 63 scratching the push conduit 20 when cutting the sheath 40. To ensure the 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 less than that of the cutting blade 63 to save cost. 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, the cutting blade 63 may be replaced with other cutting elements such as a wire.

In some alternative embodiments, the cutting mechanism 60 may be omitted from the drug-coated balloon catheter 100, which may simplify the structure of the drug-coated balloon catheter 100 and reduce the production cost. To facilitate the dissection of the proximal end of the sheath 40, the proximal end of the sheath 40 is provided with at least one axially extending secondary dissection structure 403. The auxiliary dividing structure 403 includes, but is not limited to, at least one of a fold, a plurality of spaced-apart hollow-out seams, 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 furling 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 a secondary dissection structure 403 to further rapidly cut the proximal end of the sheath 40.

Wherein the distal end of the sheath 40 is movable in the axial direction of the pusher catheter 20. Sheath 40 is preferably a tubular structure that can fit over the unexpanded drug-coated balloon 30. The sheath 40 is made of a biocompatible material. Examples of biocompatible materials include, but are not limited to, materials with a low coefficient of friction such as e-PTFE, FEP, or PET. Preferably, to facilitate axial sliding of the distal end of sheath 40 along push catheter 20, sheath 40 is made of a material having a low coefficient of friction.

Optionally, to facilitate the protrusion 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 secondary 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 furling section 401, so that the distal end of the sheath 40 moves toward the proximal direction close to the pushing catheter 20, the distal auxiliary dividing structure 403 can be opened by the drug-coated balloon 30 until being torn, and the proximal auxiliary dividing structure 403 can be cut by the cutting mechanism 60 or torn by the furling force transmitted by the winding shaft 530, so that the drug-coated balloon 30 can extend from the side of the sheath 40 close to the distal end and be exposed outside the sheath 40, thereby exposing 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 inner wall of the blood vessel of the lesion.

As shown in fig. 3 and 6 to 8, the retraction segment 401 has a retracted state and a non-retracted state. The sheath 40 further comprises a non-furling section 402 adjacent to the furling 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 pusher catheter 20 on the winding shaft 530. The radial cross section of the non-furled section 402 is a closed-loop structure, so as to avoid the loss of drug dosage caused by the high-speed blood flow scouring of the drug-coated balloon 30, thereby greatly reducing the drug loss rate of the drug-coated balloon catheter 100 in the delivery process. Since the sheath 40 is a hollow tubular structure, in the non-furled state, the radial cross-section of each furled segment 401 is substantially arc-shaped. In the furled state, each furled segment 401 is relatively far from the said push catheter 20 in the radial direction of the push catheter 20 compared to the other parts of the sheath 40 (i.e. the non-furled segments 402), thus facilitating the increase of the axial length of the furled segment 401 after the proximal end of the sheath 40 is split and avoiding interference with the push catheter 20 when the winding mechanism 53 winds the furled segment 401 of the sheath 40.

Specifically, a line L2 of the furling section 401 when furled deviates from a central axis L1 of the non-furling section 402, that is, the furling section 401 deviates from the non-furling section 402, that is, an included angle β is formed between the furling section 401 and the non-furling section 402. Optionally, the included angle β is an acute angle to avoid the problem that the furled section 401 is excessively deviated to cause the sheath to break, and to enable the furled section 401 not to interfere with the pushing catheter 20 when being wound on the winding shaft 530.

In the present 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 take-up section 401 along the axial direction of the sheath 40. The radial cross section of the retraction section 401 is substantially C-shaped. Specifically, the proximal end of sheath 40 is axially cut out of opening 4011 to form a furled segment 401, thereby effecting a deflection of furled segment 401 away from pusher catheter 20 about a winding axis 530. The distal end of the take-up segment 401 is fixedly attached to the non-take-up segment 402 and the proximal end of the take-up segment 401 is fixed to the take-up shaft 530.

Referring again to fig. 1 and 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 for winding the take-up section 401. In other embodiments, the proximal end of the sheath is split axially of the sheath into at least two segments, and both segments are wound on the 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 the present 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 a side of the connecting portion 551 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 operating portion 552 is exposed from the housing 51 and is rotatable relative to the housing 51 for operation by a user. Specifically, when the handle 552 is rotated in a first predetermined direction, the retraction section 401 is rotated about the central axis of the retraction shaft 530 to move the distal end of the sheath 40 toward the proximal end of the sheath 40 to effect the deployment of the drug-coated balloon 30 from within 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. The catheter hub 10 is disposed at the proximal end of the pusher catheter 20. Catheter hub 10 may be secured directly to the pusher catheter 20 or secured to the pusher catheter 20 via control handle 50. The catheter seat 10 is provided with a guide wire port 11 and a filling port 13, wherein the guide wire port 11 is used for a guide wire to penetrate, and the filling port 13 is used for fluid injection of a filling balloon.

The control handle 50 also includes a bumper sleeve 54 fixedly disposed on the distal end of the housing 51. The central axis of the buffer tube 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 inserted into the buffer sleeve 54, so that the push catheter 20 and the sheath 40 are prevented from being broken. 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 can be fixed together by a fastening structure, a screw locking mechanism, etc. The first housing 511 and the second housing 512 can be made of hard plastic material to save cost. The hard material includes, but is not limited to, acrylonitrile Butadiene Styrene plastic (ABS). The first housing 511 and the second housing 512 enclose a cavity 510 (see fig. 9) having two opposing through holes 5101, 5102. The buffer sleeve 54 is clamped in the through hole 5101, the catheter base 10 is clamped in the through hole 5102, and the pushing catheter passes through the buffer sleeve 54 and is connected with the catheter base 10. The first housing 511 further defines a position-avoiding opening 5111 for the operation portion 552 of the power element 55 to pass through, so as to facilitate the operation of the user. The cutting mechanism 60 and the winding mechanism 53 are both housed in the cavity 510 of the housing 51.

The push catheter 20 is provided with a guide wire lumen and an inflation lumen in the axial direction. The guide wire cavity is separated from the filling cavity and is arranged side by side. The portion of the push catheter 20 penetrating the drug-coated balloon 30 is provided with a balloon filling opening (not shown) communicating with the drug-coated balloon 30. The guide wire port 11 communicates with the guide wire lumen to enable a guide wire to pass through the guide wire port 11 and through the guide wire lumen. A guidewire lumen extends axially through the distal and proximal ends of the pusher catheter 20. The filling cavity is communicated with the filling port 13 and the balloon filling port. Thus, the inflation port 13, the inflation lumen, and the balloon inflation port form a path for inflating or deflating the drug-coated balloon 30 to enable inflation or deflation of the drug-coated balloon 30 by fluid introduced or withdrawn into the drug-coated balloon 30. Specifically, the filling port 13 can be connected to an external pressure pump, and liquid enters or flows out of 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 the 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 inside the pusher catheter 20 depending on the actual state of the diseased tissue and the time required for filling, and correspondingly, one or more filling ports 13 on the catheter hub 10.

The distal end of the pusher 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 is a common technical means in the art and is not described herein again.

Wherein the drug-coated balloon 30 is an expandable balloon. Specifically, the drug-coated balloon 30 can be selectively filled or drained with liquid, so as to improve 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 drug-coated balloon 30. In another embodiment, the drug coating may cover a portion of the outer wall of the drug-coated balloon 30. In one embodiment, the active agent coating comprises an active agent that inhibits smooth muscle cell proliferation. Optionally, in another optional embodiment, the drug coating further comprises a carrier. The carrier may be used to facilitate the rapid release of the active drug from the outer wall of the drug-coated balloon 30 or to facilitate absorption by the diseased tissue. Examples of the carrier include, but are not limited to, organic acid salts and polyhydric alcohols, and mannitol is used as the carrier in this embodiment. In the present embodiment, the active drug is a drug (e.g., paclitaxel, rapamycin, etc.) having an effect of inhibiting smooth muscle cell proliferation, and paclitaxel is used in the present embodiment.

The process of treating a lesion of a blood vessel with the drug-coated balloon catheter 100 provided in the first embodiment of the present application includes the following operations: the distal portion of drug-coated balloon catheter 100 is first delivered to the vicinity of the lesion of the blood vessel and drug-coated balloon 30 is directed at the lesion. Controlling the winding mechanism 53 to wind the furling section 401 so as to enable the distal end of the sheath 40 to move towards the proximal end, namely, the distal end of the sheath 40 moves towards the direction close to the proximal end of the pushing catheter 20 along the axial direction of the pushing catheter 20 until the drug coating balloon 30 is exposed out of the sheath 40, and at the moment, the drug coating balloon 30 is exposed at the lesion site of the blood vessel; the drug coating balloon 30 is inflated, the blood vessel of the lesion part is fully expanded after the drug coating balloon 30 is inflated, and the drug coating 32 is released from the surface of the drug coating balloon 30 and transferred to the blood vessel wall to play the drug effect; finally, the drug coating balloon 30 is decompressed, and the patient is removed from the body, 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 furling section 401 connected with the winding mechanism 53 is formed at the proximal end of the sheath 40, and the furling 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. Thus, the sheath 40 can protect the drug coating on the surface of the drug-coated balloon 30, and the drug loss rate of the drug-coated balloon catheter in the conveying process is reduced; more importantly, because 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 mode, compared with the control mode of stretching and retracting through a pipe fitting in the prior art, the length of the control handle can be obviously shortened, and the operation of a doctor is greatly facilitated; in addition, the winding mechanism 53 can correspondingly expose the balloons with different lengths according to different winding degrees of the winding section 401, so that the balloons with different lengths can be matched with the same control handle, the application range of the control handle is expanded, and purchasing and inventory management are facilitated.

Referring to fig. 9 and 10 together, a second embodiment of the present application provides a drug-coated balloon catheter 200 having a structure similar to that of the drug-coated balloon catheter 100 of the first embodiment, except that the winding mechanism 53 comprises at least two winding shafts 530, the sheath 40 comprises at least two winding segments 401, the control handle 50 further comprises a driving mechanism 57 disposed in the housing 51, and the driving mechanism 57 is used for driving each winding shaft 530 to rotate to wind the corresponding winding segment 401. The central axis of each winding shaft 530 is perpendicular to the central axis of the sheath 40.

The driving mechanism 57 comprises at least two gears 570 in transmission connection with at least two winding shafts 530, and each gear 570 comprises a gear part 5701 and a rotating shaft part 5702 which are coaxially arranged. Each of the winding shafts 530 is fixed to the corresponding rotating shaft portion 5702, and is disposed coaxially 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.

In this embodiment, the at least two winding shafts 530 comprise a first winding shaft 531 and a second winding shaft 532, and the at least two winding segments 401 comprise a first winding segment 41 and a second winding segment 42. The proximal end of the first winding segment 41 and the proximal end of the second winding segment 42 are respectively fixed on the first winding shaft 531 and the second winding shaft 532, the first winding segment 41 is located at one end of the first winding shaft 531 far from the gear portion 5701 associated with the first winding shaft 531, and the second winding segment 42 is located at one end of the second winding shaft 532 far 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 mesh in sequence. 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 serves 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, and the reliability of winding at the proximal end of the sheath 40 is improved.

Specifically, in the present 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 be used as the first winding shaft 531, and the rotating shaft portion 5702 of the fourth gear 574 can 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 and fixedly connected together. In this way, first winding shaft 531 and first gear 571, and second winding shaft 532 and fourth gear 574 can rotate synchronously, thereby ensuring smoothness and balance of winding the proximal end of sheath 40.

The first winding segment 41 and the second winding segment 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 this 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 tightly winds 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 tightly winds around the second winding shaft 532 for a preset number of turns. Wherein the preset number of turns is 3-4 turns. In other embodiments, the first winding section 41 and the second winding section 42 can be further fixed to the first winding shaft 531 and the second winding shaft 532 by bonding, pressing, snapping, screwing, or the like.

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, wherein the third gear 573 serves as a driven reversing gear. When the second gear 572 rotates in the first direction, the first gear 571 and the third gear 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 the second winding shaft 532 to rotate synchronously, but the first winding shaft 531 and the second winding shaft 532 rotate in opposite directions, the winding direction of the first winding segment 41 is adapted to the rotation direction of the first winding shaft 531, the winding direction of the second winding segment 42 is adapted to the rotation direction of the second winding shaft 532, and the first winding shaft 531 and the second winding shaft 532 continuously wind the corresponding first winding segment 41 and the second winding segment 42 in opposite directions. In this manner, the distal end of the sheath 40 is moved proximally to expose the drug-coated balloon. The winding direction of the first winding stage 41 is opposite to the winding direction of the second winding stage 42, which helps the distal end of the first winding stage 41 and the distal end of the second winding stage 4 to be continuously divided or separated by the drawing action of the first winding shaft 531 and the second winding shaft 532.

Alternatively, 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 the first gear 571 and the fourth gear 574 have a spacing therebetween. Thus, the winding space of the first winding shaft 531 and the second winding shaft 532 is increased, interference in the process that the first winding section 41 and the second winding section 42 are respectively wound by the first winding shaft 531 and the second winding shaft 532 is avoided, and the smoothness and the balance of the 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 polymer material includes, but is not limited to, polyoxymethylene (POM) and nylon. The metal material includes, but is not limited to, stainless steel.

Optionally, the control handle 50 further comprises a power element 55 fixedly connected to said driving gear. The power element 55 is used for controlling the driving gear to rotate so as to drive the driven gear and the at least two winding shafts 530 to rotate to wind the at least two winding segments 401. The power element in the first embodiment is suitable for the power element 55 in the second embodiment, and details are not described herein. In the second embodiment, the power element 55 is fixedly connected to the driving gear.

In this embodiment, the control handle 50 further includes a gear carrier 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 of the extension carriage 52, and each take-up reel 401 is wound on the extension 5301 of the respective winding shaft 530.

Specifically, the gear rack 52 includes a first bracket 521 and a second bracket 522 fixed to each other. The first 521 and second 522 brackets are removably connected together to facilitate the user's installation and removal of the roll-up section 401. The first bracket 521 and the second bracket 522 jointly enclose a receiving space 523 for receiving at least two gears 570. The second bracket 522 has a plate-shaped structure. The distal end of the second bracket 522 is provided with an extension plate 5221 for fixing the cutting mechanism 60. The cutting mechanism 60 is disposed on a side of the extension plate 5221 facing away from the first bracket 521, so as to prevent the winding section 401 from interfering with the rotation of the two gears 370 when winding on the winding shaft 530.

Each retracting segment 401 is offset with respect to the non-retracting segment 402 towards the central axis L1 away from the sheath 40, i.e. the extending direction of each retracting segment 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 of breakage caused by transition deviation of the furling section 401. By designing the extension plate 5221 to expose the first bracket 521 in this manner, there is more space below the carrier 52 to accommodate the wound segment 401, and it is further ensured that the winding mechanism 53 does not interfere with the catheter 20 when winding the segment 401 of the sheath 40.

Optionally, a stop member 58 is disposed at an end of the protruding portion 5301 of each winding shaft 530 away from the gear rack 52. A limiting space 580 is formed between the limiting member 58 and the gear rack 52, so that each furling segment 401 is positioned in the corresponding limiting space 580, and each furling segment 401 is prevented from being separated from the corresponding winding shaft 530, and the reliability of winding of the furling segments 401 on the winding shaft 530 is ensured, so that the distal end of the sheath 40 moves along the axial direction of the push catheter 20, and the drug coating 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 gear carrier 52. Both ends of each gear 570 are rotatably connected to the associated two bushings 5703, so that the friction between the gear 570 and the carrier 52 is reduced, thereby improving the smoothness of winding of the take-up section 401 of the sheath 40. It will be appreciated that the length of the wrapping segment 401 increases as the number of turns of the segment is wound increases.

Referring to fig. 9 and 12-13 together, fig. 12 is a schematic structural view of the cutting mechanism 60 of the drug-coated balloon catheter 200; fig. 13 is a cross-sectional view of the cutting mechanism 60 of the drug-coated balloon catheter 200, the sheath 40, and the pusher catheter 20 in 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 the cutting base 61 of the cutting mechanism 60.

Wherein, the two cutting blades 63 are symmetrically distributed about the central axis L1 of the sheath 40, so that the proximal cutting blade 63 of the sheath 40 can obtain the same size of the retracting segment 401 after cutting, thereby ensuring the balance of retracting of the retracting segment 401. The end of the cutting edge 631 facing away from the cutting base 61 is located between the outer wall of the pusher catheter 20 and the inner wall of the sheath 40. Specifically, the distance between the two cutting blades 63 is about 2mm to 5mm less than the inner diameter of the sheath 40 and about 2mm to 5mm greater than the outer diameter of the pusher catheter 20. In this way, the cutting blade 63 is prevented from scratching the push conduit 20 when cutting the sheath 40.

The drug-coated balloon catheter provided by the embodiment is based on the same principle as the embodiment, the length of the control handle can be obviously shortened, and the operation of a doctor is facilitated; the sacculus of different length can match same brake valve lever, has enlarged brake valve lever's application scope, also makes things convenient for purchase and inventory management, and it is no longer 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 engaged in sequence, 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 that 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 the first winding stage 41 and the second winding stage 42 can be wound relatively far away without interference.

For example, when the second gear 572 serves as a driving gear to rotate in the counterclockwise direction D1, 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 segment 41 and the second winding segment 42 respectively fixed on the first winding shaft 531 and the second winding shaft 532 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 in the axial direction toward the proximal end of the pusher catheter 20, 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, the first gear 571 is used as a driving gear, and the winding direction of the first winding segment 41 is opposite to the winding direction of the second winding segment 42. Alternatively, the first winding shaft 531 and the second winding shaft 532 are fixed to the rotating shaft of the first gear 571 and the rotating shaft of the second gear 572, respectively, and the third gear 573 is a driving gear, so that the winding direction of the first winding stage 41 is opposite to the winding direction of the second winding stage 42.

The drug-coated balloon catheter provided by the embodiment is based on the same principle as the above embodiment, and can also obviously shorten the length of the control handle, thereby facilitating the operation of a doctor; the sacculus of different length can be collocated with same brake valve lever, has enlarged brake valve lever's application scope, also makes things convenient for purchase and inventory management, and the no longer repeated here. In addition, be provided with the three gear of being connected with the winding mechanism transmission in the brake valve lever, three gear sets up side by side in proper order along the direction of perpendicular to sheath central axis, helps further reducing brake valve lever's length for brake valve lever's whole size is littleer.

Referring to fig. 15, the structure of the balloon catheter 400 with drug coating of the fourth embodiment is similar to that of the balloon catheter 200 with drug coating of the second embodiment, except that at least two gears 570 include a first gear 571 and a second gear 572 engaged with the first gear 571, the first winding shaft 531 and the second winding shaft 532 are respectively fixed on the rotating shaft of the first gear 571 and the rotating shaft of the second gear 572 correspondingly, 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 that 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 on the first winding shaft 531 in the counterclockwise direction D1, and the second winding section 42 winds 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 pushing catheter 20, thereby exposing the drug-coated balloon 30.

The drug-coated balloon catheter provided by the embodiment is based on the same principle as the embodiment, the length of the control handle can be obviously shortened, and the operation of a doctor is facilitated; the sacculus of different length can match same brake valve lever, has enlarged brake valve lever's application scope, also makes things convenient for purchase and inventory management, and it is no longer repeated here. In addition, be provided with two gears of being connected with the winding mechanism transmission in the brake valve lever, two gears set up side by side along the direction of perpendicular to sheath central axis, have not only promoted two roll-up sections's winding smoothness nature and equilibrium, and help further reducing brake valve lever's length to make brake valve lever's whole size littleer.

The above embodiments are described in detail, and specific examples are applied herein to explain the principles and embodiments of the present application, and the description of the embodiments is only used to help understand the method and the core idea of the present application; meanwhile, for a person skilled in the art, according to the idea of the present application, the specific embodiments and the application range may be changed, and in view of the above, the content of the present specification should not be construed as limiting the present application.

Claims (20)

1. The utility model provides a medicine coating sacculus pipe, includes the propelling movement pipe and is fixed in the medicine coating sacculus of the distal end of propelling movement pipe, its characterized in that, medicine coating sacculus pipe is still established including the activity cover propelling movement pipe reaches the outer sheath of medicine coating sacculus and set up in the brake valve lever of sheath near-end, brake valve lever include the casing and set up in winding mechanism on the casing, the proximal end of sheath form with the roll-up section that winding mechanism connects, winding mechanism is used for convoluteing the roll-up section, so that the distal end of sheath removes to the proximal end, thereby exposes medicine coating sacculus.

2. The drug-coated balloon catheter of claim 1, wherein the proximal end of the sheath is divided into at least one of the furled segments along an axial direction of the sheath, the winding mechanism including at least one winding shaft; all the furling sections are wound around the same winding shaft; alternatively, each said take-up segment is wound about a respective winding axis.

3. A drug-coated balloon catheter according to claim 2, wherein at least one of said segments has a furled state and a non-furled state, wherein each of said segments has a generally arcuate radial cross-section in said non-furled state; in the furled state, each of the furled segments is relatively farther from the pusher catheter in a radial direction of the pusher catheter than other portions of the sheath.

4. The drug-coated balloon catheter of claim 2, wherein the winding mechanism includes one of the winding shafts, and the control handle further includes a powered element fixedly attached to the winding shaft for controlling rotation of the winding shaft to wind the at least one take-up reel.

5. The drug-coated balloon catheter of claim 2, wherein the winding mechanism includes at least two of the winding shafts, the sheath includes at least two of the take-up segments, and the control handle further includes a drive mechanism disposed within the housing for driving each of the winding shafts in rotation to wind the respective take-up segment; the central axis of each winding shaft is perpendicular to the central axis of the sheath.

6. The drug-coated balloon catheter of claim 5, wherein the drive mechanism comprises at least two gears drivingly connected to at least two of the winding shafts, each of the gears comprising a gear portion and a shaft portion coaxially disposed, each of the winding shafts being fixed to and coaxially disposed with a corresponding shaft portion; one of the at least two gears serves as a driving gear, and the rest of the gears serve as driven gears.

7. The drug-coated balloon catheter of claim 6, wherein the at least two winding shafts include a first winding shaft and a second winding shaft, and the at least two winding segments include a first winding segment and a second winding segment, a proximal end of the first winding segment and a proximal end of the second winding segment being respectively fixed to the first winding shaft and the second winding shaft, the first winding segment being located at an end of the first winding shaft away from a gear portion associated with the first winding shaft, and the second winding segment being located at an end of the second winding shaft away from a gear portion associated with the second winding shaft.

8. The drug-coated balloon catheter according to claim 7, wherein the at least two gears include a first gear and a second gear engaged 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 is used 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 7, wherein the at least two gears include a first gear, a second gear and a third gear, which are engaged with each other in sequence, the first winding shaft and the second winding shaft are respectively fixed to the rotating shaft portion of the first gear and the rotating shaft portion of the third gear, and 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.

10. The drug-coated balloon catheter of claim 7, wherein the at least two gears comprise a first gear, a second gear, and a third gear that mesh in sequence; the first winding shaft and the second winding shaft are respectively and correspondingly fixed on the rotating shaft part of the first gear and the rotating shaft part of the second gear, the third gear is used as the driving gear, and the winding direction of the first winding section is opposite to that of the second winding section; or the first winding shaft and the second winding shaft are respectively and correspondingly fixed on the rotating shaft part of the second gear and the rotating shaft part of the third gear, the first gear is used as the driving gear, and the winding direction of the first winding section is opposite to that of the second winding section.

11. The drug-coated balloon catheter according to claim 7, wherein the at least two gears include a first gear, a second gear, a third gear and a fourth gear, which are engaged with each other in sequence, the first winding shaft and the second winding shaft are respectively fixed to the rotating shaft portion of the first gear and the rotating shaft portion of the fourth gear, and when the second gear or the third gear is used as the driving gear, the winding direction of the first winding section is opposite to the winding direction of the second winding section.

12. The drug-coated balloon catheter of claim 11, wherein the first gear and the fourth gear are symmetrically distributed about the central axis of the sheath, the second gear and the third gear are symmetrically distributed about the central axis of the sheath, and the first gear and the fourth gear have a spacing therebetween.

13. The drug-coated balloon catheter of claim 6, wherein the control handle further comprises a power element fixedly connected to the drive gear, the power element for controlling rotation of the drive gear to rotate the driven gear and the at least two winding shafts to wind the at least two winding segments.

14. The drug-coated balloon catheter of claim 6, wherein the drive mechanism further comprises a gear carrier fixedly attached to the housing, the at least two gears being rotatably attached to the gear carrier, each of the winding shafts comprising an extension extending from the gear carrier, each of the retraction segments being wound on the extension of the respective winding shaft.

15. The drug-coated balloon catheter of claim 14, wherein a limiting member is disposed at an end of the extending section of each winding shaft away from the gear carrier, and a limiting space is formed between the limiting member and the gear carrier, so that each winding section is located in the corresponding limiting space.

16. The drug-coated balloon catheter of claim 1, wherein the length of the furled segment increases as the number of turns the furled segment is wound increases.

17. The drug-coated balloon catheter of claim 16, wherein the control handle further comprises a cutting mechanism for cutting the proximal end of the sheath axially as the winding mechanism winds the furled segment to increase the length of the furled segment.

18. The drug-coated balloon catheter of claim 17, wherein the cutting mechanism comprises a cutting base and a cutting blade disposed on the cutting base, the cutting base having a through hole for the sheath to pass through axially, the cutting blade extending into the through hole, the cutting blade comprising a cutting edge extending in a direction intersecting the central axis of the sheath.

19. The drug-coated balloon catheter of claim 18, wherein an end of the cutting edge facing away from the cutting base is located between an outer wall of the push catheter and an inner wall of the sheath.

20. The drug-coated balloon catheter of claim 1, wherein the proximal end of the sheath is provided with at least one axially extending auxiliary dividing structure comprising at least one of a fold, spaced perforations, and thinned grooves; the proximal end of the sheath is segmented by the auxiliary segmentation structure to form the furling section.

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