Pressure regulation system and method of regulating fluid pressure in lumen of medical device

Abstract

The invention provides a pressure adjusting system and a method for adjusting the pressure of fluid in an inner cavity of medical equipment, and relates to a method for controlling a pressure control pump to enable the pressure of the fluid in the inner cavity of the medical equipment to change within a period of time. A coronary artery blood vessel remodeling catheter, a peripheral balloon dilatation catheter, a peripheral blood vessel remodeling catheter, an intracranial laser balloon dilatation catheter, a drug coating balloon dilatation catheter, a photodynamic balloon catheter, a mastoid balloon catheter, a constraint type balloon dilatation catheter and a spinous process balloon can be made. Expansion and contraction of a balloon body in a balloon catheter such as a drug delivery balloon catheter are regularly changed within a period of time, and therefore the treatment effect is better achieved.

Description

TECHNICAL FIELD

[0001] The present application relates to the technical field of medical devices, in particular to a pressure regulating system and a method for regulating fluid pressure in a balloon lumen of a medical device. BACKGROUND

[0002] Vascular diseases have been close to the first cause of human death, and most of the vascular diseases, whether organic or functional, have the basic pathological change of ischemic change of organs caused by stenosis or occlusion of vascular lumen, such as neointimal proliferation caused by cell and tissue damage of the vascular wall, which is easy to cause restenosis of the vascular lumen.

[0003] In order to treat vascular diseases, a series of balloon catheters have been developed for a wide range of medical catheterization procedures, including angioplasty, stent delivery and local drug delivery. Such balloon catheters include papillary balloon catheters for crushing vascular plaques in the lesion site when the balloon body is expanded; constraint balloon dilation catheters (also known as chocolate balloons) which can orderly expand the blood vessels when the balloon body is expanded by providing a cage structure made of nickel-titanium wire on the outer surface of the balloon body, while avoiding the generation of disordered flow-limiting layers; scored balloons which can effectively crush hard plaques by providing one or more scored wires made of nickel-titanium alloy or the like on the outer surface of the balloon body when the balloon body is expanded; and spinous balloon catheters which can form cracks by extruding plaques when the balloon body is expanded by providing three 120° distributed spinous wires or spinous rib elements usually made of high molecular materials such as nylon on the outer surface of the balloon body, and can also prevent the balloon body from slipping.

[0004] Another type of balloon catheter, called drug delivery balloon catheter, is also widely used at present. As an important interventional instrument, this type of balloon catheter is used to deliver drugs to the lesion site of the vascular system or body organs of mammals including humans, and can be divided into two categories: drug-coated balloon catheters and drug-infusion balloon catheters, wherein the drug-coated balloon catheter loads drugs (such as inhibitors for inhibiting vascular intimal hyperplasia, or photosensitive cross-linking agents) on the outer surface of the balloon body in the form of a coating, and then delivers the balloon body to the lesion site in the body to release the drugs, while the drug-infusion balloon catheter infuses a liquid containing drugs into the lumen of the balloon body and then flows out to the lesion site near the balloon body through the apertures provided on the balloon body wall.

[0005] Regardless of the balloon catheter, after the balloon catheter is guided to the lesion site in the body under the guidance of a guide element such as a guide wire or a suture, fluid needs to be applied to the balloon body to expand it. When the fluid is applied, it is crucial to control the pressure in the balloon body lumen. For example, in a drug delivery balloon catheter, the drug release process is not easy to control, which will affect the treatment effect, so whether the pressure in the balloon body lumen can be well controlled is crucial to whether the drug can be fully released to the vascular lesion site.

[0006] US6050973A discloses that the fluid pressure injected into the balloon body is limited to a desired cut-off pressure by providing a piston movable between an open position and a closed position, when the fluid pressure in the balloon body is lower than the cut-off pressure, the piston is in the open position to allow fluid to be injected into the balloon body to increase the fluid pressure in the balloon body, when the fluid pressure in the balloon body reaches the cut-off pressure, the piston is in the closed position to prevent fluid from being injected into the balloon body. CN114053009A discloses that by controlling the sliding of the pressurizing displacement assembly in the sliding cavity, when it is necessary to pressurize the balloon stent, the gas in the sliding cavity can be pushed to the balloon stent to complete the pressurizing work of the balloon stent, at the same time, the internal pressure of the balloon stent is detected by the pressure detection assembly to ensure that the internal pressure of the balloon stent reaches the preset pressure, avoiding that the internal pressure of the balloon stent is too large or too small. However, both of them maintain the fluid pressure in the balloon body at a fixed level, although it can avoid the fluid pressure in the balloon body from being too large to exceed the burst pressure and cause the balloon body to burst, but this cannot fully exert the treatment effect, for example, in a drug delivery balloon catheter, maintaining the fluid pressure in the balloon body at a fixed level cannot fully release the drug.

[0007] CN208823744U discloses that in a balloon catheter system, a hollow balloon body is provided with a vibration structure unit inside, when the balloon body is filled and expanded, the drug covered on the surface of the balloon body contacts the blood vessel wall, the balloon body enters a vibration state, thereby promoting the drug to be absorbed by the blood vessel wall. However, since this vibration structure unit is arranged inside the balloon body, it will sacrifice the flexibility of the drug-eluting balloon catheter, and also complicate the structural design of the drug-eluting balloon catheter.

[0008] Japanese Patent JP6830814B2 discloses a drug delivery catheter device in which a heating unit located within the balloon cavity heats the liquid injected into the balloon cavity to 60°C to 90°C when the balloon expands, thereby raising the blood vessel wall to the same temperature. This promotes the penetration of the drug coated on the balloon surface into the blood vessel wall in a relatively short time. However, given that the heating unit is located inside the balloon and the liquid within the balloon cavity needs to be heated to such a high temperature, strict temperature control and human safety controls are required for the drug delivery catheter device, making its structural design extremely complex.

[0009] Therefore, there is an urgent need to design a simple and easy-to-implement pressure regulation system and method to make the fluid pressure inside the balloon change regularly during balloon expansion, thereby achieving better therapeutic effects. Summary of the Invention

[0010] To address the shortcomings of existing technologies, this invention provides a balloon catheter system, the balloon catheter system comprising: A balloon catheter, comprising a tube body and a balloon body, the tube body having a distal end and a proximal end and a fluid cavity, the balloon body being disposed on the periphery of the distal end of the tube body, the inner cavity of the balloon body communicating with the fluid cavity, and the proximal end of the tube body having a fluid injection port communicating with the fluid cavity; A pressure control pump is provided, which has a fluid communication section. This fluid communication section is connected to the fluid injection port and the inner cavity of the balloon body in a fluid pathway. When the balloon body is delivered to the target site within the body and fluid is injected into the balloon body and the fluid communication section, the pressure regulation module, after operation, can sequentially raise the fluid pressure within the inner cavity of the balloon body to p1, ..., p... n Where n is an integer, n≥2, p x-1 ≠p x Let x be an integer, 2≤x≤n, and let the fluid pressure in the inner cavity of the balloon be repeatedly adjusted according to p1→...→p over a time period t. n →p1 change pattern change.

[0011] The present invention also provides a pressure regulating system, the pressure regulating system comprising: A medical device having an internal cavity and a fluid injection interface connected in a fluid passage; A pressure control pump having a fluid communication portion in fluid communication with a lumen of the medical device and a fluid injection port, the pressure control module being operable to cause the fluid pressure in the lumen of the medical device to reach pi,..., pn, respectively, and then p1→...→pn, respectively, over a period of time t, where n is an integer, n > 2, pi ≠ pn, x is an integer, 2 < x < n, and then pi again, after the medical device has been delivered to a target site in or near a subject and fluid has been injected into the lumen of the medical device and the fluid communication portion. n where n is an integer, n > 2, pi ≠ pn, x is an integer, 2 < x < n, and then pi again, after the medical device has been delivered to a target site in or near a subject and fluid has been injected into the lumen of the medical device and the fluid communication portion. x-1 where n is an integer, n > 2, pi ≠ pn, x is an integer, 2 < x < n, and then pi again, after the medical device has been delivered to a target site in or near a subject and fluid has been injected into the lumen of the medical device and the fluid communication portion. x where n is an integer, n > 2, pi ≠ pn, x is an integer, 2 < x < n, and then pi again, after the medical device has been delivered to a target site in or near a subject and fluid has been injected into the lumen of the medical device and the fluid communication portion. n where n is an integer, n > 2, pi ≠ pn, x is an integer, 2 < x < n, and then pi again, after the medical device has been delivered to a target site in or near a subject and fluid has been injected into the lumen of the medical device and the fluid communication portion.

[0012] The present application also provides a method of varying the fluid pressure in a lumen of a balloon, the method comprising: delivering a balloon to a target site in a subject, the balloon being in a balloon catheter in fluid communication with a pressure control pump, the balloon catheter comprising a tube having opposite distal and proximal ends and a fluid lumen, and the balloon, the balloon being disposed about the tube at the distal end thereof, the balloon having a lumen in fluid communication with the fluid lumen, the proximal end of the tube having a fluid injection port in fluid communication with the fluid lumen, the pressure control pump having a fluid communication portion in fluid communication with the fluid injection port and the lumen of the balloon; injecting fluid into the balloon and the fluid communication portion, the fluid causing the balloon to expand, the pressure control module being operable to cause the fluid pressure in the lumen of the balloon to reach pi,..., pn, respectively, and then p1→...→pn, respectively, over a period of time t, where n is an integer, n > 2, pi ≠ pn, x is an integer, 2 < x < n, and then pi again, after the balloon has been delivered to a target site in or near a subject and fluid has been injected into the lumen of the balloon and the fluid communication portion. n where n is an integer, n > 2, pi ≠ pn, x is an integer, 2 < x < n, and then pi again, after the medical device has been delivered to a target site in or near a subject and fluid has been injected into the lumen of the medical device and the fluid communication portion. x-1 where n is an integer, n > 2, pi ≠ pn, x is an integer, 2 < x < n, and then pi again, after the medical device has been delivered to a target site in or near a subject and fluid has been injected into the lumen of the medical device and the fluid communication portion. x where n is an integer, n > 2, pi ≠ pn, x is an integer, 2 < x < n, and then pi again, after the medical device has been delivered to a target site in or near a subject and fluid has been injected into the lumen of the medical device and the fluid communication portion. n where n is an integer, n > 2, pi ≠ pn, x is an integer, 2 < x < n, and then pi again, after the medical device has been delivered to a target site in or near a subject and fluid has been injected into the lumen of the medical device and the fluid communication portion.

[0013] The present application also provides a method of varying the fluid pressure in a lumen of a balloon, the method comprising: delivering a balloon to a target site in a subject, the balloon being in a balloon catheter in fluid communication with a pressure control pump, the balloon catheter comprising a tube having opposite distal and proximal ends and a fluid lumen, and the balloon, the balloon being disposed about the tube at the distal end thereof, the balloon having a lumen in fluid communication with the fluid lumen, the proximal end of the tube having a fluid injection port in fluid communication with the fluid lumen, the pressure control pump having a fluid communication portion in fluid communication with the fluid injection port and the lumen of the balloon; After the lumen and fluid communicating part of the medical device is filled with fluid, the pressure regulating module is operated to make the fluid pressure in the lumen of the medical device reach p1,...,p n , where n is an integer, n≥2, p x-1 ≠p x , x is an integer, 2≤x≤n, and the fluid pressure in the lumen of the medical device is repeatedly changed according to the change mode of p1→...→p n →p1 in a time period t.

[0014] In the present application, the fluid communicating part is the part of the pressure control pump that is connected to the fluid injection interface in the fluid passage and can contain fluid, and the volume of which can be changed after being adjusted.

[0015] Further, the medical device is a balloon catheter, which comprises a tube body and a balloon body, the lumen of the medical device is the lumen of the balloon body, the tube body has opposite distal and proximal ends and is provided with a fluid cavity, the balloon body is arranged on the outer periphery of the distal end of the tube body, the lumen of the balloon body is in communication with the fluid cavity, and the fluid injection interface of the medical device is arranged at the proximal end of the tube body and is in communication with the fluid cavity.

[0016] Further, 0<|p x-1 -p x |≤16atm, preferably, 1atm<|p x-1 -p x |≤16atm. Further, 2atm<|p x-1 -p x |≤6atm.

[0017] Further, for any two adjacent p x-1 and p x , the time interval of p x-1 →p x is denoted as t x-1 ; for p n and p1, the time interval of p n →p1 is denoted as t n , t x-1 can be divided into a pressure maintaining time period t m x-1 and a pressure changing time period t c x-1 , t n can be divided into a pressure maintaining time period t m n and a pressure changing time period t c n , t m x-1≥10ms and t m n ≥10ms. Furthermore, t m x-1 =t m n and t c x-1 =t c n , or ∑t x-1 (x=2,..., n)=t n .

[0018] Furthermore, in t c x-1 and t c n At that time, p x-1 →p x and p n →The pressure change pattern between p1 is selected from one of the following patterns: (1) a linear change pattern, (2) a nonlinear change pattern. Further, the nonlinear change pattern is characterized by alternating peaks and troughs for p. x-1 →p x In terms of min(p) x-1 ,p x ) <p x-1 and p x Fluid pressure between each peak <max(p x-1 ,p x ), min(p x-1 ,p x ) <p x-1 and p x Fluid pressure at each trough <max(p x-1 ,p x ); for p n →For p1, min(p n p1) <p n Fluid pressure at each peak between p1 and p1 <max(p n ,p1),min(p n p1) <p n Fluid pressure at each trough between p1 and p1 <max(p n (p1).

[0019] Furthermore, let p1→...→p n →p1 represents a single change, with a change frequency f of 3~500 times / min and t of 10s~30min. Further, f can be 30~200 times / min and t can be 20s~10min.

[0020] Further, n = 2, p1 < p2, or p1 > p2. Further, n = 3, and the change pattern of p1 → p2 → p3 → p1 is selected from one of the following patterns: (1) p1 < p2 < p3; (2) p1 < p2, p2 > p3, p1 = p3; (3) p1 < p2, p2 > p3, p1 < p3; (4) p1 < p2, p2 > p3, p1 > p3; (5) p1 > p2 > p3; (6) p1 > p2, p2 < p3, p1 = p3; (7) p1 > p2, p2 < p3, p1 < p3; (8) p1 > p2, p2 < p3, p1 > p3.

[0021] In some cases, in order to deliver the balloon catheter of the present invention to the target site in the body (such as atherosclerotic sites, calcified sites and other diseased sites), the tube body is further provided with a guide wire channel, so that the guide wire can pass through during interventional delivery. Under the guidance of the guide wire, the balloon catheter can be delivered to the target site in the body.

[0022] Further, the pressure control pump includes a pressure regulation module, and the pressure regulation module includes a housing, a bolt, a rubber plug and a knob. The rubber plug is arranged in the inner cavity of the housing and is hermetically connected with the inner cavity of the housing. One end of the bolt is arranged in the inner cavity of the housing and is fixed together with the rubber plug. The part of the housing between the distal end of the housing and the rubber plug is the fluid communication part. The other end of the bolt passes through the proximal end of the inner cavity of the housing and is connected with the knob. By rotating the knob counterclockwise or clockwise, the volume of the fluid communication part can be changed. In some cases, the pressure control pump is replaced by a pulsating pump or an electromagnetic pump.

[0023] Further, the pressure control pump further includes a three-way valve. Further, the pressure regulation module is further provided with a pressure gauge, and the pressure gauge is arranged on the side wall of the housing, or on the fluid passage between the three-way valve and the distal end of the housing, or on the fluid passage between the three-way valve and the fluid injection interface.

[0024] Further, the pressure control pump is an electromagnetic pump. The pressure control pump includes a pressure regulation module, and the pressure regulation module includes a pump body, a magnetic core plunger device installed in the pump body, and an electromagnetic device sleeved outside the pump body. The part of the pump body between the distal end of the pump body and the magnetic core plunger device is the liquid communication part. One end of the pump body is connected to the fluid injection interface in the fluid passage. The electromagnetic device can generate a pulsed electromagnetic field to push the magnetic core plunger device to reciprocate in the pump body, so that the volume of the liquid communication part continuously changes periodically.

[0025] Further, the pressure control pump is a pulsating pump, the pressure control pump comprises a pressure regulating module, the pressure regulating module comprises a pump body, a handle and a piston, the pump body is fixedly connected with the handle, the piston is located in the pump body, the piston is in close contact with the inner wall of the pump body and can move along the inner wall of the pump body, the part of the pump body between the distal end of the pump body and the piston is a liquid communication part, one open end of the pump body is in communication with the fluid injection interface on the fluid passage, and the piston can reciprocate in the pump body, so that the volume of the liquid communication part changes periodically.

[0026] Further, the balloon body is loaded with drugs, and the drugs are coated on the outer surface of the balloon body in the form of a coating.

[0027] Further, the balloon body has pores on the balloon wall, and the pores can output the drug-containing fluid flowing into the balloon body lumen through the fluid cavity by the drug delivery device to the target site near the balloon body.

[0028] Further, the outer surface of the balloon body is distributed with a plurality of radially outward papillary points. Further, one or more notched wires made of nickel-titanium alloy are coated on the outer surface of the balloon body. Further, three spinous process wires or spinous process rib elements distributed at 120° are arranged on the outer surface of the balloon body. Further, a plurality of axially spaced columns and a plurality of axially spaced radially expandable rings are arranged on the balloon body, and the plurality of axially spaced columns and the plurality of axially spaced radially expandable rings form a cage structure. In some cases, each axial column and each radially expandable ring is made of a metal wire such as a nickel-titanium wire or nylon.

[0029] The application also provides a novel pulsating pump, which comprises a base plate, a motor, a working shaft, a connecting piece and a fixing block, the motor and the fixing block are directly or indirectly fixedly connected to the base plate, one end of the working shaft is fixedly connected to the motor, the other end of the working shaft is sleeved with the connecting piece, the connecting piece is located between the motor and the fixing block, a pressure regulating section of a connecting pipe is located between the connecting piece and a side wall of the fixing block closest to the motor, and the connecting piece and the fixing block cooperate to prevent the pressure regulating section from falling off from the connecting piece and the fixing block when the motor is working.

[0030] Further, the connecting pipe is fixedly connected to the inside or the side wall of the fixing block, and the connecting pipe is fixedly connected to the inside or the side wall of the connecting piece.

[0031] Further, the fixed block is provided with a first channel and a second channel which are penetrated from inside the fixed block or fixedly connected to at least one side wall of the fixed block; the connecting piece is provided with a penetration channel on two opposite side walls, and the connecting pipe is sequentially penetrated from the first channel, the penetration channel and the second channel.

[0032] Further, the connecting piece is provided with a plurality of parallel penetration channels on two opposite side walls, and the connecting pipe is sequentially penetrated from the first channel, the plurality of penetration channels and the second channel, and a section of the connecting pipe between the plurality of penetration channels is in a spiral structure.

[0033] Further, the fixed block is provided with a first channel and a second channel which are penetrated from inside the fixed block or fixedly connected to at least one side wall of the fixed block; the connecting piece is provided with a penetration channel on two opposite side walls, and the connecting pipe is sequentially penetrated from the first channel, the penetration channel and the second channel.

[0034] Further, the pulsating pump comprises a positioning plate, the positioning plate is divided into a flat section and a vertical section, the vertical section is fixedly connected to the top of the flat section, the flat section is fixedly connected to the bottom plate, the motor is fixedly arranged on the flat section and fixedly connected with the vertical section, the vertical section is provided with a penetration hole, one end of the motor is penetrated from the penetration hole and fixedly connected with the motor.

[0035] Further, the fixed block is divided into an upper cover and a base, the upper cover is provided with parallel first upper half channel and second upper half channel on the bottom, the base is provided with parallel first lower half channel and second lower half channel on the top, when the upper cover and the base are assembled together, the first upper half channel and the first lower half channel form the first channel of the fixed block, and the second upper half channel and the second lower half channel form the second channel of the fixed block.

[0036] Further, the bottom of the upper cover is provided with a first row of glue injection grooves and a second row of glue injection grooves, the adjacent glue injection grooves in the first row of glue injection grooves and the second row of glue injection grooves are spaced apart by a certain distance, the first upper half channel is located between the first row of glue injection grooves and the second row of glue injection grooves, and the groove direction of each glue injection groove in the first row of glue injection grooves and the second row of glue injection grooves is perpendicular to the first upper half channel and terminates at the first upper half channel; the bottom of the upper cover is also provided with a third row of glue injection grooves and a fourth row of glue injection grooves, the adjacent glue injection grooves in the third row of glue injection grooves and the fourth row of glue injection grooves are spaced apart by a certain distance, the second upper half channel is located between the third row of glue injection grooves and the fourth row of glue injection grooves, and the groove direction of each glue injection groove in the third row of glue injection grooves and the fourth row of glue injection grooves is perpendicular to the second upper half channel and terminates at the second upper half channel.

[0037] Further, the top of the base is also provided with a first groove and a second groove, the first lower half channel is located between the first groove and the second groove, the bottom of the first groove and the second groove terminates at the first lower half channel, the first groove is located directly below the first row of glue injection grooves, and the second groove is located directly below the second row of glue injection grooves; the top of the base is also provided with a third groove and a fourth groove, the second lower half channel is located between the third groove and the fourth groove, the bottom of the third groove and the fourth groove terminates at the second lower half channel, the third groove is located directly below the third row of glue injection grooves, and the fourth groove is located directly below the fourth row of glue injection grooves.

[0038] Further, the part of the bottom plate for supporting the fixing block is provided with at least one fixing channel penetrating through the upper and lower surfaces of the bottom plate, the bottom of the fixing block is provided with at least one row of inwardly recessed fixing holes, the number of rows of fixing holes is the same as the number of fixing channels, and each row of fixing holes corresponds to one fixing channel, and for each fixing hole, one fixing member is fixedly connected with the fixing hole through the corresponding fixing channel.

[0039] The application also provides a novel pulsating pump, which comprises a bottom plate, a motor, a fixing block, a cylindrical cam male head, a cylindrical cam female head and a cover plate, the motor and the fixing block are directly or indirectly fixedly connected to the bottom plate, one section of a connecting pipe serving as a pressure adjusting section is fixed between the fixing block and the cover plate, and the cover plate and the fixing block are fixedly connected together. The cylindrical cam male head can be divided into a base part and a rod-shaped part, the rod-shaped part is formed by extending from the base part to the fixing block by a distance, one end of the base part is fixedly connected to the working shaft of the motor, and the opposite end of the base part is spaced apart along the outer periphery and is provided with convex structures and concave structures. The fixed block is provided with a through channel, the cylindrical cam head is arranged in the through channel and can axially slide along the through channel, one end of the cylindrical cam head is provided with an inwardly recessed connecting channel, the connecting channel of the cylindrical cam head can axially slide the rod-shaped part, and one end of the connecting channel of the cylindrical cam head is distributed with convex structures and concave structures along the outer periphery. Each convex structure and each concave structure on the base part respectively matches each concave structure and each convex structure on the connecting channel of the cylindrical cam head in shape, each convex structure on the base part is switched between matching one concave structure on the connecting channel of the cylindrical cam head and aligning with one convex structure on the connecting channel of the cylindrical cam head at intervals when the motor works, each concave structure on the base part is switched between matching one convex structure on the connecting channel of the cylindrical cam head and aligning with one concave structure on the connecting channel of the cylindrical cam head at intervals synchronously, thereby driving the cylindrical cam head to axially slide along the through channel towards or away from the fixed block.

[0040] Further, the pulsating pump further comprises a positioning plate, the positioning plate is divided into a flat section and a vertical section, the vertical section is fixed perpendicularly to the flat section, the vertical section is located between the flat section and the fixed block, the motor is arranged on the flat section and fixedly connected with the vertical section, a through hole is arranged in the vertical section, one end of the base part is provided with an inwardly recessed connecting channel and passes through the through hole, and the connecting channel of the base part is fixedly connected with the working shaft of the motor.

[0041] Further, the fixed block is divided into a flat part and a vertical part, one end of the flat part close to the motor is used for fixing the vertical part, and the other end of the flat part is used for supporting the cover plate, and the through channel of the fixed block is arranged in the vertical part.

[0042] Further, one side wall of the vertical part close to the cover plate is provided with an inwardly recessed first transverse groove, and one side wall of the cover plate close to the vertical part is provided with an inwardly recessed second transverse groove, the two spatially aligned transverse grooves form a complete fixing groove when the fixed block and the cover plate are assembled together, and the connecting pipe passes through the fixing groove; the first transverse groove is divided into two parts by the through channel and is located on both sides of the through channel; and one side wall of the cover plate close to the vertical part is further provided with an inwardly recessed extrusion groove, the extrusion groove is spatially aligned with the through channel, and the extrusion groove spatially intersects the second transverse groove.

[0043] Further, the depth of the extrusion groove is greater than the depth of the second lateral groove, the extrusion groove divides the second lateral groove into two, the first segment and the second segment of the second lateral groove are located on both sides of the extrusion groove, and the connecting pipe does not contact the bottom of the extrusion groove.

[0044] Further, the depth of the extrusion groove is less than or equal to the depth of the second lateral groove, the extrusion groove divides the second lateral groove into three, the first segment and the second segment of the second lateral groove are located on both sides of the extrusion groove, and the third segment of the second lateral groove is located between the first segment and the second segment and is arranged at the bottom of the extrusion groove.

[0045] Further, the depth of the third segment is less than the depth of the first segment and the second segment, and is equal to the difference between the depth of the first segment or the second segment and the depth of the second lateral groove.

[0046] Further, the width of the cover plate is greater than the width of the fixed block, the opposite first end and second end of the side wall of the cover plate closest to the vertical part are exposed from the fixed block; the first end of the side wall of the cover plate is provided with a first upper glue discharging small groove and a first lower glue discharging small groove, the first segment is located between the first upper glue discharging small groove and the first lower glue discharging small groove, adjacent glue discharging small grooves in the first upper glue discharging small groove and the first lower glue discharging small groove are spaced apart at a distance, and the groove direction of each glue discharging small groove is perpendicular to the second lateral groove and terminates at the first segment, and the first upper glue discharging small groove and the first lower glue discharging small groove are located in the exposed part of the first end of the side wall. The second end of the side wall of the cover plate is provided with a second upper glue discharging small groove and a second lower glue discharging small groove, the second segment is located between the second upper glue discharging small groove and the second lower glue discharging small groove, adjacent glue discharging small grooves in the second upper glue discharging small groove and the second lower glue discharging small groove are spaced apart at a distance, and the groove direction of each glue discharging small groove is perpendicular to the second lateral groove and terminates at the second segment, and the second upper glue discharging small groove and the second lower glue discharging small groove are located in the exposed part of the second end of the side wall.

[0047] Further, the first upper glue discharging small groove and the second upper glue discharging small groove are distributed on both sides of the extrusion groove and are spatially aligned, and the first lower glue discharging small groove and the second lower glue discharging small groove are distributed on both sides of the extrusion groove 952 and are spatially aligned.

[0048] Furthermore, the portion of the base plate used to support the fixing block is provided with at least one fixing channel penetrating the upper and lower surfaces of the base plate, and the bottom of the fixing block is provided with at least one row of inwardly recessed fixing holes. The number of rows of fixing holes is the same as the number of fixing channels, with each row of fixing holes corresponding to one fixing channel. For each fixing hole, a fixing member passes through the corresponding fixing channel and is fixedly connected to the fixing hole.

[0049] This invention provides a balloon catheter system and a method for altering the fluid pressure within the balloon cavity. The method allows for periodic changes in the fluid pressure within the balloon cavity during balloon inflation, thereby enabling the balloon in various types of balloon catheters, such as coronary artery remodeling catheters, peripheral balloon dilation catheters, intracranial laser balloon dilation catheters, drug-coated balloon dilation catheters, photodynamic balloon catheters, mastoid balloon catheters, restraint balloon dilation catheters, spinous process balloons, and drug delivery balloon catheters, to periodically change according to a pre-set pattern over a period of time, thus enhancing the therapeutic effect. Attached Figure Description

[0050] To more clearly illustrate the technical solutions in the embodiments of this application or the conventional technology, the drawings used in the description of the embodiments or the conventional technology will be briefly introduced below. Obviously, the drawings described below are only some embodiments of this application. For those skilled in the art, other drawings can be obtained based on these drawings without creative effort.

[0051] Figure 1 This is a schematic diagram of the balloon catheter of Embodiment 1 of the present invention; Figure 2 This is a schematic diagram of the balloon catheter in Embodiment 1 of the present invention when the guidewire is located outside the balloon body; Figure 3 for Figure 2 A schematic diagram showing the positions of the tubular body, double-lumen tube, and balloon body within the balloon; Figure 4 for Figure 2 A schematic diagram of the cross-section of the double-lumen tube; Figure 5 This is a schematic diagram of the pressure control pump in Embodiment 1 of the present invention; Figure 6 This is a schematic diagram of the balloon catheter of Embodiment 7 of the present invention; Figure 7 This is a three-dimensional schematic diagram of the papillary balloon catheter of Embodiment 8 of the present invention; Figure 8 for Figure 7 A three-dimensional schematic diagram of the central saccule; Figure 9 for Figure 7 Left view of the middle saccule; Figure 10 This is a schematic diagram of the balloon catheter in Embodiment 9 of the present invention; Figure 11 This is a schematic diagram of a pressure regulating implementation part with a through channel on the side wall of the connector in Embodiment 2 of the present invention. The connecting pipe is omitted to show the through channel. Figure 12 This is a schematic diagram of a pressure regulating implementation part with a notch at one end of the connector in Embodiment 2 of the present invention; Figure 13 for Figure 11 or Figure 12 The exploded view of the fixed block is shown with the bottom of the top cover facing upwards for easier observation. Figure 14 This is a simplified schematic diagram showing the circuit connection in Embodiments 2, 3, or 4 of the present invention, as well as the connection between the connecting tube and the inner cavity of the housing or pump body and the balloon catheter in the fluid passage. Figure 15 This is a schematic diagram of the pressure regulating implementation unit in Embodiment 4 of the present invention. In order to observe the transverse groove on the side wall of the cover plate, the cover plate is disassembled from the pressure regulating implementation unit, and the side wall of the cover plate with the transverse groove is shown. In addition, at a certain moment when the geared motor is working, the convex structure on the base of the cylindrical cam male head fits into the concave structure on the connecting channel of the cylindrical cam female head. Figure 16 This is a schematic diagram of the pressure regulating implementation unit in Embodiment 4 of the present invention. In order to observe the transverse groove on the side wall of the cover plate, the cover plate is disassembled from the pressure regulating implementation unit, and the side wall of the cover plate with the transverse groove is shown. In addition, at a certain moment when the geared motor is working, the convex structure on the base of the cylindrical cam male head contacts the convex structure on the connecting channel of the cylindrical cam female head. Figure 17 for Figure 16 A schematic diagram showing the pressure regulating actuators assembled together. Figure 18 for Figure 16 A schematic diagram of the bottom of the base plate when the pressure regulating mechanism is assembled. Figure 19 for Figure 16 Exploded view of the pressure regulation implementation unit in the middle; Figure 20 for Figure 16 The diagram shows the male and female cylindrical cam heads at two different angles. Detailed Implementation

[0052] In order to make the above objectives, features and advantages of the present application more clear and comprehensible, the detailed description of the specific embodiments of the present application is made below with reference to the accompanying drawings. In the following description, a lot of specific details are set forth in order to provide a thorough understanding of the present application. However, the present application can be implemented in many different ways other than the one described herein, and one of ordinary skill in the art can make similar improvements without departing from the scope of the present application, and therefore the present application is not limited to the specific embodiments disclosed below.

[0053] It is noted that when an element is referred to as being "on" or "connected to" another element, it can be directly on the other element or intervening elements can also be present. When an element is referred to as being "connected to" another element, it can be directly connected to the other element or intervening elements can also be present. The terms "vertical", "horizontal", "upper", "lower", "left", "right" and similar expressions as used in the description of the specification are for the purpose of illustration only and do not indicate the only position of the embodiment.

[0054] In addition, the terms "first", "second", etc. are used herein only to describe various elements, and do not imply or suggest relative importance or a number of the technical features indicated. Thus, the features defined as "first", "second" can explicitly or implicitly include at least one of the features. In the description of the present application, the meaning of "a plurality of" is at least two, such as two, three, etc., unless otherwise specifically limited.

[0055] In the present application, unless otherwise specifically defined and limited, the "on", "under", "above" and "over" of the first feature to the second feature can be that the first feature is directly in contact with the second feature, or the first feature is indirectly in contact with the second feature through an intermediate medium. Moreover, the "on", "above" and "over" of the first feature to the second feature can be that the first feature is directly above or obliquely above the second feature, or only indicates that the first feature is higher than the second feature in horizontal height (or in a use state, or in a certain drawing perspective). The "under", "below" and "under" of the first feature to the second feature can be that the first feature is directly below or obliquely below the second feature, or only indicates that the first feature is lower than the second feature in horizontal height (or in a use state, or in a certain drawing perspective).

[0056] Unless otherwise defined, all technical and scientific terms used in the specification of the present application have the same meaning as commonly understood by one of ordinary skill in the art to which the present application belongs. The terms used in the specification of the present application are only for the purpose of describing the specific embodiments and are not intended to limit the present application. The term "and / or" used in the specification of the present application includes any and all combinations of one or more of the related listed items.

[0057] When used to indicate direction, the proximal end in the text generally refers to the side closest to the operator (e.g., a doctor), and the distal end is the side relatively far away. Correspondingly, each component itself has a relative distal end and a proximal end. When used to refer to a structure, the "end" in the text indicates the endpoint of the structure or a point or region in that lateral direction, or a specific structure connected to that point or region.

[0058] Example 1: A novel balloon catheter like Figures 1-4 As shown, a novel balloon catheter 100 includes a tube body 130 having opposing distal and proximal ends, the tube body 130 providing at least a fluid cavity and an optical fiber cavity; a balloon body 110 located on the periphery of the distal portion of the tube body 130 and communicating with the fluid cavity; and an optical fiber 120 passing through the optical fiber cavity and having a light-emitting segment extending to the location of the balloon body 110. The light-emitting segment of the optical fiber 120 can be fabricated by physically stripping (e.g., sandblasting, grinding, scraping, etc.) or chemically stripping the cladding of the portion of the optical fiber 120 located within the balloon body 110.

[0059] The balloon catheter system 100 also includes a catheter seat 140 and a stress relief tube 150. The stress relief tube 150 is connected between the tube body 130 and the catheter seat 140. The catheter seat 140 is connected to the proximal end of the tube body 130 and has interfaces that communicate with the fluid cavity and the fiber cavity respectively, namely the fluid injection interface 141 and the fiber cavity interface 142. After the fiber optic cable 120 extends out of the fiber cavity, it is connected to the light generation module through the fiber optic connector 160.

[0060] A light-generating module, connected to the near end of optical fiber 120, includes a light source. The light-generating module can drive the light-emitting segment of optical fiber 120 to emit light of different wavelengths, such as blue light or red light, according to different needs. Blue light can cause drugs such as photosensitive crosslinking agents to react with collagen and / or elastin in the vascular lesion site to form a vascular microscaffold, while red light can repair cells and tissues in the vascular lesion site.

[0061] A drug is coated on the outer surface of the balloon body 110 in the form of a coating. In some cases, the thickness of the coating is 1-100 μm, for example 10-80 μm, for example 20-50 μm. In some cases, the amount of drug coated in the coating is 1-8 g / m2, for example 2-6 g / m2, for example 2-4 g / m2, relative to the unit balloon surface area. The drug used can be an inhibitor of vascular intimal hyperplasia for preventing vascular restenosis, and can be selected from at least one of rapamycin, sirolimus, everolimus, zotarolimus, 42-(dimethylphosphino) rapamycin, biolimus, umirolimus, tacrolimus, paclitaxel, protaxel, docetaxel. In order to facilitate the transfer of the drug, the inhibitor of vascular intimal hyperplasia can be used in combination with a carrier substance, which plays a key role in ensuring the effective absorption and retention of the drug in the vascular wall. For example, paclitaxel is usually used in combination with a carrier substance such as iopromide, butyryl trihexyl citrate (BTHC) and urea to enhance the adhesion and transfer of paclitaxel.

[0062] The drug used can also be a photosensitive cross-linking agent, which can be selected from at least one of porphyrin, porphyrin derivative compound, phthalocyanine, chlorin, purpurin, 5-hydroxyacetic acid, 4-amino-1,8-naphthalimide, 1,8-naphthalimide, 1,8-naphthalimide multimer, dimeric naphthalimide compound, 2,2'-((ethane-1,2-di(oxy))bis(ethane-2,1-diyl)bis(6-((2-(2-(2- aminoethoxy)ethyl)amino)-1H-benzo[de]isoquinoline-1,3(2H)-dione, 6-[2-[2-(2- aminoethoxy)ethoxy]ethylamino]-2-[2-[2-[2-[6-[2-[2-(2- aminoethoxy)ethoxy]ethylamino]-1,3-dioxobenzo[de]isoquinoline-2-yl]ethoxy]ethoxy] ethylamino]benzo[de]isoquinoline-1,3-dione, 2,2'-[1,2-ethanediylbis(oxy-2,1- ethanediyl)]bis[6-({2-[2-(2-aminoethoxy)ethoxy]ethyl}amino)-1H-benzo[de]isoquinoline- 1,3(2H)-dione], 1H-benzo[de]isoquinoline-1,3(2H)-dione, 2,2'-[1,2-ethanediylbis(oxy-2,1- ethanediyl)]bis[6-[[2-[2-(2-aminoethoxy)ethoxy]ethyl]amino]-(9Cl), N-5-azido-2- nitrobenzoyloxy succinimide, N-(beta-maleimidopropoxy)succinimide ester, N-[e- maleimidocaproyloxy]succinimide ester, N-[gamma-maleimidobutyryloxy]succinimide, succinimidyl-6-(3-[2-pyridyldithio]-propionamido)hexanoate, m-maleimidobenzoyl-N- hydroxysuccinimide ester, 3-[2-pyridyldithio]propionhydrazide, N-succinimidyl bromoacetate, N-succinimidyl iodoacetate, N-sulfosuccinimidyl iodoacetate, succinimidyl-4-[N- maleimidomethyl]cyclohexane-1-carboxylate, N-succinimidyl 4-[4-maleimidophenyl]butyrate, succinimidyl-6-[beta-maleimidopropionamido]hexanoate, N-succinimidyl 3-[2- pyridyldithio]-propionate, sulfosuccinimidyl 6-(3'-[2-pyridyldithio]-propionamido)hexanoate, m-maleimidobenzoyl-N-hydroxysulfosuccinimide ester, N-sulfosuccinimide-6-[4'- azido-2'-nitrophenylamino]hexanoate, and sulfosuccinimidyl-4-[N-maleimidomethyl] cyclohexane-1-carboxylate.

[0063] In addition, the drug used can be a mixture of an inhibitor for inhibiting vascular intimal hyperplasia and a photosensitive crosslinking agent, and when the therapeutic agent is loaded in the form of a coating, the coating can be any one of the following structures: the coating is sequentially formed on the outer surface of the balloon body 110 by an inhibitor layer and a photosensitive crosslinking agent layer, and the thickness of each layer is 1-50 μm; or the coating is a layer containing the inhibitor and the photosensitive crosslinking agent. The loading method of the coating is to prepare a solution of the coating in advance, apply the solution to the surface of the balloon, and then dry. In the coating, the mass ratio of the inhibitor to the photosensitive crosslinking agent is 1:0.2-5, for example, 1:1-4, and for example, 1:2-3.

[0064] In use, the balloon body 110 is first filled with fluid by injecting the fluid into the fluid lumen of the tube body 130, and then light of a specific wavelength range is emitted by the light generating module, the light is emitted by the light emitting section of the optical fiber 120, and after being scattered by the balloon body 110, the fluid in the balloon body 110, and the balloon body 110, the light irradiates the lesion site for a period of time to achieve a therapeutic effect.

[0065] The tube body 130 includes an inner tube 132 and an outer tube 131 nested inside and outside each other, the distal end of the balloon body 110 is sealingly connected to the outer wall of the inner tube 132, and the proximal end of the balloon body 110 is sealingly connected to the outer tube 131, the inner tube 132 and the outer tube 131 have a radial gap, and the radial gap is a fluid lumen, and the lumen of the inner tube 132 is an optical fiber lumen. The balloon body 110 includes an equal diameter section 113 and tapered sections 114 located at both ends of the equal diameter section 113.

[0066] The tube body 130 has at least one section in the axial direction as a double lumen tube 133, the double lumen tube 133 includes a fluid lumen 138 and a guide wire channel 137, the fluid lumen 138 and the guide wire channel 137 are parallel to each other and isolated from each other, and the fluid lumen 138 is in communication with the radial gap of the inner tube 132 and the outer tube 131.

[0067] The inner tube 132 extends out of the tube wall of the distal end portion of the balloon body 110, and a first guide wire port 134 is formed therein, the two ends of the guide wire channel 137 are respectively a second guide wire port 135 and a third guide wire port 136, and the guide wire 180 runs as shown in the figure Figure 2 In use, the guide wire 180 enters the guide wire channel 137 of the double lumen tube from the third guide wire port 136, then extends to the outside of the balloon body 110 from the second guide wire port 135, and then enters the lumen of the inner tube from the first guide wire port 134, and the diameter of the lumen of the inner tube is 0.54-0.80 mm. Further preferably, the diameter of the lumen of the inner tube is 0.54-0.74 mm.

[0068] The first guide wire port, the second guide wire port and the third guide wire port are aligned in the axial direction of the tube body. The distance D1 between the first guide wire port and the distal end of the balloon body is 5-20 mm, and the distance D2 between the second guide wire port and the proximal end of the balloon body is 10-30 mm. Further preferably, the distance D1 between the first guide wire port and the distal end of the balloon body is 5-15 mm, and the distance D2 between the second guide wire port and the proximal end of the balloon body is 10-30 mm.

[0069] The balloon body 110 can be a bare balloon or a profiled balloon. The material of the balloon body needs to have sufficient flexibility, good passability, and can smoothly reach the intended site, while meeting excellent processing performance, good resilience, fatigue resistance and dimensional stability. Preferably, the material of the balloon body is one of PEBAX, nylon and TPU. Further preferably, the material of the balloon body is PEBAX or nylon.

[0070] To adjust the fluid pressure in the balloon body 110, a variety of pressure control pumps can be used. The first pressure control pump includes a pressure regulating module, which includes a housing 1, a bolt 2, a rubber plug 3, a knob 4, a pressure gauge 5 and a three-way valve 6. The inner cavity of the housing 1 extends from the distal end of the housing 1 to the proximal end of the housing 1. The inner cavity of the housing 1 is in fluid communication with the three-way valve 6 at the distal end, and one end of the bolt 2 extends through the proximal end of the housing 1 into the inner cavity of the housing 1 and is fixed with the rubber plug 3 which is sealingly connected with the inner wall of the housing 1. The sealing connection between the rubber plug 3 and the inner wall of the housing 1 can be achieved by providing an O-ring. The other end of the bolt 2 extends out of the proximal end of the housing 1 and is connected with the knob 4. The rubber plug 3 divides the inner cavity of the housing 1 into two parts: a fluid containing part 11 and a fluid isolation part 12. By rotating the three-way valve 6, the fluid containing part 11 can be in fluid communication with the fluid injection interface 141, and thus in fluid communication with the inner cavity of the balloon body 110, while the fluid isolation part 12 is not in fluid communication with the fluid injection interface 141, but in fluid communication with the air outside the housing 1. Of course, the proximal end of the housing 1 can be sealed so that the fluid isolation part 12 becomes a sealed chamber. The pressure gauge 5 is sealingly arranged on the side wall of the housing 1 and can be used to measure the fluid pressure in the fluid containing part 11. Of course, the pressure gauge 5 can also be sealingly arranged on the distal end of the housing 1, on the pipeline between the three-way valve 6 and the distal end of the housing 1, or on the pipeline between the three-way valve 6 and the fluid injection interface 141. When the injected fluid is a liquid, the air in the fluid passage between the inner cavity of the balloon body 110 and the fluid containing part 11 can be in communication with the air in the external environment by rotating the three-way valve 6, thereby expelling the air in the fluid passage. After the air is expelled, the inner cavity of the balloon body 110 and the fluid containing part 11 are connected in fluid communication by rotating the three-way valve 6. Of course, the three-way valve 6 can not be provided, and before use, a negative pressure pump can be used to remove the air in the fluid passage between the inner cavity of the balloon body 110 and the fluid containing part 11. In addition, the pressure gauge 5 can be replaced by a pressure sensor.

[0071] The three-way valve 6 is connected to the fluid injection port 141 through the connecting tube 7, so that when the balloon body 110 is expanded, a portion of the fluid is filled into the fluid containing portion 11 of the housing 1 through the connecting tube 7 and the three-way valve 6, so that the fluid containing portion 11 of the housing 1 is connected in fluid communication with the inner cavity of the balloon body 110, and thus the fluid pressure measured by the pressure gauge 5 is equal to the fluid pressure in the inner cavity of the balloon body 110. When the knob 4 is rotated clockwise (i.e. the rotation direction shown by the arrow 13), the knob 4 drives the rubber plug 3 to move towards the distal end of the housing 1 through the screw 2, so that the volume of the fluid containing portion 11 is reduced and the volume of the fluid isolation portion 12 is increased, and at least a portion of the fluid in the fluid containing portion 11 is squeezed out of the inner cavity of the housing 1, thereby increasing the fluid pressure in the inner cavity of the balloon body 110, and the fluid pressure can be known by the fluid pressure displayed by the pressure gauge 5. When the knob 4 is rotated counterclockwise (i.e. the rotation direction shown by the arrow 14), the knob 4 drives the rubber plug 3 to move towards the proximal end of the housing 1 through the screw 2, so that the volume of the fluid containing portion 11 is increased and the volume of the fluid isolation portion 12 is reduced, and more fluid is injected into the fluid containing portion 11, thereby reducing the fluid pressure in the inner cavity of the balloon body 110, and the fluid pressure can be known by the fluid pressure displayed by the pressure gauge 5. Since the fluid containing portion 11 of the housing 1 is connected in fluid communication with the inner cavity of the balloon body 110, whether the knob 4 is rotated clockwise or counterclockwise, the fluid volume in the inner cavity of the balloon body 110 is changed, thereby changing the expansion and contraction amplitude of the balloon body 110 accordingly. Of course, the knob 4 and the screw 2 can be replaced by a handle of a common syringe, and the handle extends from the proximal end of the housing 1 and is fixedly connected to the rubber plug 3, and the fluid pressure in the balloon body is adjusted by adjusting the volume change of the fluid containing portion 11 by axially pushing and pulling the handle.

[0072] The material of the connecting tube 7 can be selected from at least one of nylon, TPU, PVC, PA, PEPBAX, silicone and the like. In addition, the connecting tube 7 can also be selected from a flexible tubular material woven by fibers or metal wires. Therefore, the connecting tube 7 can be a single-layer tube or a braided tube.

[0073] After the three-way valve 6 is connected to the fluid injection interface 141 through the connecting pipe 7 (for example, the connecting pipe 7 is connected to the fluid injection interface 141 through a three-way pipe), the initial pressure of the fluid is first set to a large value p1, for example, 12 atm, by rotating the knob 4 clockwise, so that the drug coating on the surface of the balloon body 110 adheres to the vascular wall of the lesion site, and then the pressure of the fluid is reduced to p2 (p2 < p1), for example, 8 atm, by rotating the knob 4 counterclockwise, and then the pressure of the fluid is increased to p1 by rotating the knob 4 clockwise again, so that the knob 4 is repeatedly rotated in this rhythm, and the pressure of the fluid is constantly changed in the mode of p1→p2→p1, and at the same time, the balloon body 110 also follows the change rule of expansion→contraction→expansion according to the pressure change mode of the fluid. This makes the balloon body 110 vibrate regularly with the change of the fluid pressure, so that the drug on the surface of the balloon body 110 can be more fully released into the vascular wall. p1→p2→p1 is one change, and the application finds that when the change frequency f is 3-500 times / min (preferably 30-200 times / min), and the change duration t is 10 s-30 min (preferably 20 s-10 min), the drug release effect is best, and more drugs are released to the vascular lesion site, which makes the bioavailability of the drug relatively high. The absolute value of the difference between p1 and p2 is denoted as |p1-p2|, and in some cases, 0<|p1-p2|≤16atm. In some cases, 1atm<|p1-p2|≤16atm. In some cases, 2atm<|p1-p2|≤6atm.

[0074] Of course, the pressure of the fluid in the balloon cavity can also be adjusted by rotating the knob 4 to reach p1,..., p n , where n is an integer, n≥2, p x-1 ≠p x , x is an integer, 2≤x≤n. In some cases, 0<|p x-1 -p x |≤16atm. In some cases, 1atm<|p x-1 -p x |≤16atm. In some cases, 2atm<|p x-1 -p x |≤6atm. The pressure of the fluid in the balloon cavity is constantly changed in the mode of p1→...→p n →p1 within a period of time. For any two adjacent p x-1 and p x , the time interval of p x-1 →p x , that is, the change of the fluid pressure from p x-1 to px The required time is denoted as t. x-1 ; for p n Compared to p1, p n →p1 time interval (i.e., fluid pressure from p) n The time required for the change to p1 is denoted as t. n Regardless of t x-1 Or t n Each time interval can be divided into two parts according to the time sequence: the pressure maintenance period and the pressure change period. Specifically, t x-1 It can be divided into pressure maintenance time period t m x-1 and the time period t of pressure change c x-1 (m represents maintenance, c represents change), t n It can be divided into pressure maintenance time period t m n and the time period t of pressure change c n In some cases, t m x-1 ≥10ms and t m n ≥10ms, t m x-1 =t m n and t c x-1 =t c n In some cases, t m x-1 ≥10ms and t m n ≥10ms, p1→...→p n Total time interval and t n Equal, i.e., ∑t x-1 (x=2,..., n)=t n In some cases, t m x-1 ≥10ms and t m n ≥10ms, at t c x-1 and t c n At that time, p x-1 →p x and p nThe pressure change pattern between →p1 can be linear (e.g., linearly decreasing or linearly increasing) or nonlinear. Nonlinear patterns can be graphs or geometric curves with alternating peaks and troughs, such as sine, cosine, or sawtooth curves. They can also be nonlinear monotonically increasing or decreasing patterns, such as monotonically increasing or decreasing segments within geometric curves like exponential, elliptic, circular, hyperbolic, logarithmic, parabolic, sine, cosine, and sawtooth curves. For any chosen x, p x-1 →p x and p n →The pressure change pattern between p1 and p2 can be both linear and nonlinear, or it can be p1 / p2 ... x-1 →p x The pressure change pattern during the pressure change period is a linear pattern, p n →The pressure change pattern between p1 and p1 during the pressure change period is a non-linear change pattern, or p x-1 →p x The pressure change pattern during the pressure change period is a non-linear change pattern, p n →The pressure change pattern between p1 and p1 during the pressure change period is a linear change pattern. When x≥3, p x-2 →p x-1 p x-1 →p x and p n →The pressure change patterns between p1 and p1 during the pressure change period can simultaneously be linear or nonlinear. Alternatively, one of them can be linear while the other two are nonlinear, or one can be nonlinear while the other two are linear. Furthermore, even if two of the pressure change patterns are both linear or nonlinear, different linear patterns (e.g., two straight lines with different slopes and intercepts) or different nonlinear patterns (e.g., one a sine curve and the other an exponential curve) can be selected.

[0075] When the nonlinear variation pattern is characterized by alternating peaks and troughs, for p x-1 →p x In terms of p x-1 and p x The absolute value of the fluid pressure difference between each peak and each trough is less than |p x-1 -p x |, the fluid pressure at each peak and max(p x-1 ,p x (referring to taking p)x-1 and p x The absolute value of the difference between the two maximum values ​​is less than |p x-1 -p x |, the fluid pressure at each trough and min(p x-1 ,p x (referring to taking p) x-1 and p x The absolute value of the difference between the two minimum values ​​is less than |p x-1 -p x |;For p n →Regarding p1, p n The absolute value of the fluid pressure difference between each peak and each trough between p1 and p1 is less than |p1|. n -p1|, the fluid pressure at each peak and max(p n The absolute value of the difference between p1 and p2 is less than |p1. n -p1|, the fluid pressure at each trough and min(p n The absolute value of the difference between p1 and p2 is less than |p1. n -p1|. In some cases, for p x-1 →p x In terms of min(p) x-1 ,p x ) <p x-1 and p x Fluid pressure between each peak <max(p x-1 ,p x ), min(p x-1 ,p x ) <p x-1 and p x Fluid pressure at each trough <max(p x-1 ,p x ); for p n →For p1, min(p n p1) <p n Fluid pressure at each peak between p1 and p1 <max(p n ,p1),min(p n p1) <p n Fluid pressure at each trough between p1 and p1 <max(p n (p1). In some cases, for p x-1 →p x In terms of min(p) x-1 ,p x )+10%×|p x-1 -p x |≤p x-1 and p x The fluid pressure value of each peak between them is ≤ min(p)x-1 ,p x )+90%×|p x-1 -p x |,min(p x-1 ,p x )+10%×|p x-1 -p x |≤p x-1 and p x The fluid pressure value of each trough between the waves is ≤ min(p x-1 ,p x )+90%×|p x-1 -p x |;For p n →For p1, min(p n ,p1)+10%×|p n -p1|≤p n The fluid pressure value of each peak between p1 and p1 is ≤ min(p n ,p1)+90%×|p n -p1|,min(p n -p1)+10%×|p n -p1|≤p n The fluid pressure value of each trough between p1 and p2 is ≤ min(p1 / p2). n ,p1)+90%×|p n -p1|. In some cases, for p x-1 →p x In terms of min(p) x-1 ,p x )+40%×|p x-1 -p x |≤p x-1 and p x The fluid pressure value of each peak between them is ≤ min(p) x-1 ,p x )+80%×|p x-1 -p x |,min(p x-1 ,p x )+10%×|p x-1 -p x |≤p x-1 and p x The fluid pressure value of each trough between the waves is ≤ min(p x-1 ,p x )+50%×|p x-1 -p x |;For p n →For p1, min(p n ,p1)+40%×|p n -p1|≤pn the fluid pressure value between each peak of pi and p2 is ≤ min(pi, p2) + 80% x |pi - p2| n n the fluid pressure value between each peak of pi and p2 is ≤ min(pi, p2) + 80% x |pi - p2| n the fluid pressure value between each peak of pi and p2 is ≤ min(pi, p2) + 80% x |pi - p2| n the fluid pressure value between each peak of pi and p2 is ≤ min(pi, p2) + 80% x |pi - p2| n the fluid pressure value between each peak of pi and p2 is ≤ min(pi, p2) + 80% x |pi - p2| n the fluid pressure value between each peak of pi and p2 is ≤ min(pi, p2) + 80% x |pi - p2| n the fluid pressure value between each peak of pi and p2 is ≤ min(pi, p2) + 80% x |pi - p2|

[0076] When n = 2, the change pattern of pi → p2 → pi can be (1) pi < p2; (2) pi > p2. When n = 3, the change pattern of pi → p2 → p3 → pi can be (1) pi < p2 < p3; (2) pi < p2, p2 > p3, pi = p3; (3) pi < p2, p2 > p3, pi < p3; (4) pi < p2, p2 > p3, pi > p3; (5) pi > p2 > p3; (6) pi > p2, p2 < p3, pi = p3; (7) pi > p2, p2 < p3, pi < p3; (8) pi > p2, p2 < p3, pi > p3. The fluid pressure in the balloon lumen is constantly changing in the pattern of pi → p2 → p3 → pi over a period of time.

[0077] In some cases, pi < p2, pi ≤ p x 2 ≤ x ≤ n. At this time, when n = 3, the change pattern of pi → p2 → p3 → pi can be (1) pi < p2 < p3; (2) pi < p2, p2 > p3, pi = p3; (3) pi < p2, p2 > p3, pi < p3. The fluid pressure in the balloon lumen is constantly changing in the pattern of pi → p2 → p3 → pi over a period of time; when n = 2, the change pattern of pi → p2 → pi can be pi < p2.

[0078] ​The fluid injected into the balloon body during the expansion of the balloon body can be selected from a gas or a liquid, preferably a liquid, because compared with a liquid, a gas is more affected by temperature or pressure changes, which can cause the gas to expand unevenly, resulting in excessive local pressure of the balloon body and causing the balloon body to burst, thereby causing an infection in the body. In addition, after the balloon body bursts, gas leaks, and a large amount of gas enters the vascular lesion site instantaneously, gathers in the body, and is easy to form a gas embolus, causing blood circulation disorders and even endangering life. When using a gas, excessive pressure (greater than 2 atm) is more likely to cause the balloon body to burst and the gas to leak. This does not mean that a gas cannot be used as a fluid, but when a gas is used as a fluid, more stringent control measures need to be taken to ensure safety in the body. In addition, the balloon catheter of the present application is not limited to being used in vascular lesions, and when used in situations such as tracheal expansion, a gas can be used as a fluid. When using a liquid, a liquid with a similar osmotic pressure to body fluid can be selected, such as normal saline.

[0079] The second pressure control pump in the embodiment is an electromagnetic pump, such as the micro electromagnetic pump disclosed in Chinese Patent CN210422911U. The electromagnetic pump includes a pressure regulating module, and the pressure regulating module includes a pump body, a magnetic core plunger device installed in the pump body, and an electromagnetic device sleeved outside the pump body. The part of the pump body between the distal end of the pump body and the magnetic core plunger device is a liquid containing part. The pump body has a tubular structure with two open ends. In use, one end of the pump body is connected to the fluid injection interface of the tube body 130 in fluid communication through a connecting tube. The electromagnetic device drives the magnetic core plunger device to reciprocate in the pump body by generating a pulsed electromagnetic field, so that the volume of the liquid containing part in the pump body changes periodically, and thus the fluid pressure in the lumen of the balloon body 110 also changes periodically. A pressure gauge can also be provided in the electromagnetic pump to monitor the change in fluid pressure.

[0080] In addition, the third pressure control pump in the embodiment is a pulsatile pump, such as the one disclosed in Chinese Patent CN210933378U. The pulsatile pump includes a pressure regulating module, and the pressure regulating module includes a pump body, a handle, and a piston. The pump body is fixedly connected with the handle, and the piston is located in the pump body and tightly contacts with the inner wall of the pump body and can move along the inner wall of the pump body. The part of the pump body between the distal end of the pump body and the piston is a liquid containing part. In use, one open end of the pump body is connected to the fluid injection interface of the tube body 130 in fluid communication through a connecting tube. The piston reciprocates in the pump body, so that the volume of the liquid containing part in the pump body changes periodically, which causes the fluid pressure in the lumen of the balloon body 110 to also change periodically. A pressure gauge can also be provided in the pulsatile pump to monitor the change in fluid pressure.

[0081] Regardless of the pressure control pump, the fluid communication part of the pressure control pump can be located inside the pressure regulating module or outside the pressure regulating module, as long as the fluid communication part is connected in fluid communication with the inner cavity of the balloon body in the fluid passage when the fluid pressure in the balloon body changes, can accommodate fluid and change in volume, such as the liquid containing part of each pressure control pump in Embodiment 1 is a fluid communication part, the lumen of the pressure control section in Embodiment 2 is a fluid communication part, and the lumen of the connecting pipe located above the extrusion groove or at the bottom of the groove in Embodiment 3 is a fluid communication part. The control of the pressure regulating module can be manual control or automatic control. As known by those skilled in the art, when automatic control is used, the knob 4 or the handle can be controlled by providing electronic elements such as motors, microprocessors, pressure sensors, and PCB circuit boards.

[0082] Embodiment 2: A new pulsatile pump This embodiment is a fourth pressure control pump of the present application, which is also a new pulsatile pump, as shown in Figures 11-13 The difference between this embodiment and the first pressure control pump in Embodiment 1 is that the pressure regulating module further comprises a pressure regulating implementation part 8, and the pressure regulating implementation part 8 comprises a bottom plate 81, a positioning plate 82, a stepping motor 83, and a fixed block 84. The positioning plate 82 is divided into two parts: a flat section 821 and a vertical section 822, and the vertical section 822 is fixed vertically on the top of the flat section 821, preferably designed as one piece. The flat section 821 and the fixed block 84 are fixedly connected to the top of the bottom plate 81, such as the flat section 821 being arranged at one end of the bottom plate 81 and the fixed block 84 being arranged at the opposite end of the bottom plate 81. The vertical section 822 is located between the flat section 821 and the fixed block 84 and can be used to determine the installation position of the stepping motor 83. The stepping motor 83 is arranged on the top of the flat section 821 and fixedly connected with the vertical section 822, such as being fixedly connected with the vertical section 822 through a plurality of fixing members 824, which can be selected from screws, bolts-nuts, or studs-nuts. A through hole 823 is arranged on the vertical section 822. Of course, the positioning plate 82 can also be omitted, and in this case, the stepping motor 83 is only fixedly connected to the top of the bottom plate 81.

[0083] A gap is left between the stepper motor 83 and the fixed block 84. One end of the working shaft 85 is fixedly connected with the stepper motor 83 through the through hole 823. When the stepper motor 83 is powered on, the working shaft 85 will rotate. The other end of the working shaft 85 is located between the stepper motor 83 and the fixed block 84 and is sleeved with the connecting piece 86. The connecting piece 86 can be made of common plastic or metal materials and can adopt geometric shapes such as cylinders and cuboids. In some cases, a through channel 861 is arranged on the side wall of the connecting piece 86, so that the connecting pipe 7 can pass through the through channel 861 from one side of the connecting piece 86 to the opposite side of the connecting piece 86. Of course, multiple parallel through channels 861 can also be arranged according to the needs. At this time, the connecting pipe 7 presents a spiral structure when passing through the multiple parallel through channels 861. Whether a single through channel 861 is arranged or multiple parallel through channels 861 are arranged, the initial direction of the connecting pipe 7 entering the connecting piece 86 is deflected from the direction of the connecting pipe 7 finally leaving the connecting piece 86, and the deflection angle is 60°-180°, preferably 180°. In some cases, the connecting piece 86 is not provided with the through hole 861, but the connecting pipe 7 is fixedly connected to the side wall of the connecting piece 86.

[0084] In some cases, the fixed block 84 is provided with a first channel 841 and a second channel 842. In some cases, the two channels pass through the inside of the fixed block 84. In some cases, the two channels do not pass through the inside of the fixed block 84, but are fixedly connected to the side walls of the fixed block 84, such as two tubular pieces being fixedly connected to two opposite side walls of the fixed block 84 as the first channel 841 and the second channel 842. The connecting pipe 7 passes through the first channel 841, the through channel 861 and the second channel 842 in sequence. In some cases, the fixed block 84 can also not be provided with the first channel 841 and the second channel 842, but the connecting pipe 7 is directly fixedly connected to two opposite side walls of the fixed block 84, such as by arranging multiple ring-shaped pieces, each of which is fixed to the fixed block 84 by a screw or the like fixing piece. In this way, the connecting pipe 7 can pass through each ring-shaped piece. At this time, the connecting pipe 7 is fixedly connected to one side wall of the fixed block 84, passes through the through channel 861, and is then fixedly connected to the other opposite side wall of the fixed block 84.

[0085] In some cases, the connecting member 86 is not provided with a through channel 861, but the end of the connecting member 86 facing the fixing block 84 is provided with an inwardly recessed notch 862, and a fixing member 863 passes through two opposite side walls of the notch 862 from the side of the connecting member 86, the direction in which the fixing member 863 passes through the notch 862 is perpendicular to the recessed direction of the notch 862, and preferably, the notch 862 is located at the middle part of the end of the connecting member 86 facing the fixing block 84. The fixing member 863 can be selected from a screw, a bolt-nut or a stud-nut. At this time, the connecting pipe 7 passes through the first channel 841, the gap between the fixing member 863 and the bottom of the notch 862 and the second channel 842 in sequence.

[0086] Regardless of the form, a section of the connecting pipe 7 is located between a side wall of the fixing block 84 closest to the stepping motor 83 and the connecting member 86, which is called the pressure regulating section 71. When the stepping motor 83 works, the working shaft 85 drives the pressure regulating section 71 to rotate, thereby extruding the fluid in the pressure regulating section 71, which will cause the volume of the pressure regulating section 71 to decrease, thus increasing the fluid pressure in the connecting pipe 7. When the pressure regulating section 71 is extruded, the connecting pipe 7 does not fall off from the fixing block 84 and the connecting member 86 under the limitation of the fixing block 84 and the connecting member 86. In the present application, regardless of whether the connecting pipe 7 passes through the inside of the fixing block 84 and the connecting member 86, or is fixed to a side wall of the fixing block 84 and the connecting member 86, or a section of the connecting pipe 7 passes through the inside of the fixing block 84 and another section is fixed to a side wall of the connecting member 86, or other connection forms are adopted, as long as the pressure regulating section 71 does not fall off from the fixing block 84 and the connecting member 86 during the extrusion when the stepping motor 83 works. In some cases, the pressure regulating section 71 remains horizontal when in the initial position, i.e. parallel to the bottom plate 81, at this time the pressure regulating section 71 is not extruded. The fluid communicating part of the pressure control pump is the lumen of the pressure regulating section 7.

[0087] In some cases, the fixing block 84 can be divided into an upper cover 843 and a base 844, and the upper cover 843 can cover the base 844. The bottom of the upper cover 843 is provided with parallel first upper half channel 841-1 and second upper half channel 842-1, and the top of the base 844 is provided with parallel first lower half channel 841-2 and second lower half channel 842-2. When the upper cover 843 and the base 844 are assembled together, the first upper half channel 841-1 and the first lower half channel 841-2 form the first channel 841 of the fixing block 84, and the second upper half channel 842-1 and the second lower half channel 842-2 form the second channel 842 of the fixing block 84, and preferably, the first upper half channel 841-1 and the first lower half channel 841-2 are semicircular, and the second upper half channel 842-1 and the second lower half channel 842-2 are semicircular, of course, other geometric shapes can also be selected as needed.

[0088] The bottom of the upper cover 843 is also provided with two rows of glue injection grooves 845, and the distance between adjacent glue injection grooves 845 in each row of glue injection grooves 845 is certain. The first upper half channel 841-1 is located between the two rows of glue injection grooves 845, and the groove direction of each glue injection groove 845 is perpendicular to the first upper half channel 841-1 and ends at the first upper half channel 841-1. When the connecting pipe 7 passes through the first upper half channel 841-1, the solidified glue (such as UV glue) can be injected into each glue injection groove 845 to firmly fix the connecting pipe 7 in the first upper half channel 841-1. The bottom of the upper cover 843 is also provided with two rows of glue injection grooves 846, and the distance between adjacent glue injection grooves 846 in each row of glue injection grooves 846 is certain. The second upper half channel 842-1 is located between the two rows of glue injection grooves 846, and the groove direction of each glue injection groove 846 is perpendicular to the second upper half channel 842-1 and ends at the second upper half channel 842-1. When the connecting pipe 7 passes through the second upper half channel 842-1, the liquid solidified glue can be injected into each glue injection groove 846 to firmly fix the connecting pipe 7 in the second upper half channel 842-1. The distance between adjacent glue injection grooves in each row of glue injection grooves 845 or 846 is adjustable, as long as the connecting pipe 7 can be fixed in the first upper half channel 841-1 and the second upper half channel 842-1 after the solidified glue is injected into each row of glue injection grooves.

[0089] The top of the base 844 is also provided with two grooves 847 between which the first lower half channel 841-2 is located, the bottom of each groove 847 terminates at the first lower half channel 841-2, that is, one side wall in each groove 847 which is parallel to and closest to the first lower half channel 841-2 is at least partially missing, preferably completely missing. Each groove 847 is located directly below a corresponding row of glue injection slots 845, which allows the cured glue injected into each glue injection slot 845 to first leak into the groove 847 located directly below each row of glue injection slots 845 if some of the cured glue leaks downward, and the cured glue leaked into the groove 847 can also be used to fix the connecting pipe 7 located in the first lower half channel 841-2. The top of the base 844 is also provided with two grooves 848 between which the second lower half channel 842-2 is located, the bottom of each groove 848 terminates at the second lower half channel 841-2, that is, one side wall in each groove 848 which is parallel to and closest to the second lower half channel 842-2 is at least partially missing, preferably completely missing. Each groove 848 is located directly below a corresponding row of glue injection slots 846, which allows the cured glue injected into each glue injection slot 846 to first leak into the groove 848 located directly below each row of glue injection slots 846 if some of the cured glue leaks downward, and the cured glue leaked into the groove 848 can also be used to fix the connecting pipe 7 located in the second lower half channel 842-2.

[0090] The portion of the base plate 81 used to support the fixing block 84 has multiple parallel fixing channels 811 penetrating the upper and lower surfaces of the base plate 81. Preferably, the direction of these fixing channels is parallel to or perpendicular to the length direction of the base plate 81. Of course, one such fixing channel can also be provided as needed. In this case, the bottom of the fixing block 84 has multiple rows of inwardly recessed fixing holes, the number of rows of fixing holes being the same as the number of fixing channels. Each row of fixing holes has at least one fixing hole, for example, three fixing holes spaced at a certain distance. When the fixing hole is a thermoplastic nut, for each fixing hole, a screw can be selected and fixedly connected to the fixing hole by passing through the corresponding fixing channel. Furthermore, the purpose of setting a fixed channel on the base plate 81 is to adjust the distance between the fixed block 84 and the vertical section 822 by adjusting the fixed position of the fixed block 84 on the fixed channel 811. This is because, depending on the specifications of the balloon catheter or the different fluid pressure control requirements in the balloon, the initial size of the pressure regulating section 71 can be increased by increasing the distance between the two. If the pressure regulating section 71 is rotated by the same angle θ using the stepper motor 83, the increase in fluid pressure in the balloon will be smaller than before the increase. Conversely, if the initial size of the pressure regulating section 71 is reduced by decreasing the distance between the two, the increase in fluid pressure in the balloon will be larger than before the increase when the pressure regulating section 71 is rotated by the same angle θ using the stepper motor 83.

[0091] like Figure 14 As shown, one end of the connecting pipe 7 is connected to the inner cavity of the housing 1 or the pump body. Figure 14 (represented by SC) is connected in the fluid pathway, and the other end of the connecting tube 7 is connected to the balloon catheter ( Figure 14 (represented by BC) are connected in the fluid passage, and this connection can be achieved using a three-way valve or a three-way pipe (not shown in the diagram). Of course, Figure 14 The BC in the middle can also be replaced by other medical devices (such as Terumo's balloon-type radial artery compressor), as long as the fluid pressure inside the medical device also needs to be adjusted. In this case, the inner cavity of the medical device can be connected to one end of the connecting tube 7 in the fluid passage. The stepper motor 83 and the printed circuit board 86 are connected together in the circuit, and the printed circuit board is connected together with the power supply 87 in the circuit. When the printed circuit board 86 is connected to a high-power power supply 87 (such as a 220V AC power supply), a voltage adjustment module 88 can be connected between the printed circuit board 86 and the power supply 87 to reduce the voltage so that the pressure adjustment section 71 is not over-compressed when it is squeezed. Figure 14 In this context, IE can represent the pressure regulating implementation unit in Embodiment 2, Embodiment 3, or Embodiment 4, and M represents the motor in the pressure regulating implementation unit, which can be a stepper motor in Embodiment 2, a linear motor in Embodiment 3, or a geared motor in Embodiment 4.

[0092] The control switch 89 is arranged on the printed circuit board 86, and can also be arranged between the power supply 87 and the printed circuit board 86, or between the printed circuit board 86 and the stepping motor 83, or other appropriate positions on the circuit. Before the control switch 89 is turned on, the knob 4 or the push-pull handle is rotated to adjust the pressure in the fluid passage to an initial value p1 (the pressure value can be displayed by the pressure gauge 5 or the pressure sensor), and then the control switch 89 is turned on, and the stepping motor 83 drives the working shaft 85 to rotate in one direction (clockwise or counterclockwise), for example, clockwise at least one turn. Such rotation will extrude the pressure adjusting segment 71 and make the pressure adjusting segment 71 knotted, and the greater the rotation angle in one direction, the more the pressure adjusting segment 71 is knotted, thereby increasing the fluid pressure in the balloon body more. When the control switch is turned off, the pressure adjusting segment 71 rotates in the opposite direction, and the number of knots of the pressure adjusting segment 71 is reduced, or even reset to the initial position. The opening and closing of the control switch 89 is controlled by the microprocessor on the printed circuit board 86, so that the pressure adjusting segment 71 can be regularly extruded and reset, thereby realizing regular changes of the fluid pressure in the balloon body. The printed circuit board 86 can also be provided with a memory, and the pressure control program set in advance is stored in the memory, and when used, the microprocessor can call the pressure control program from the memory to accurately control the change of the fluid pressure in the balloon body. In addition, the microprocessor can also control the working shaft 85 of the stepping motor 83 to rotate in a certain direction for a certain angle and then keep for a period of time, at which time the fluid pressure in the balloon body can be maintained at a certain specific value for a period of time. For example, when the initial pressure p1 = 8 atm, the control switch 89 is turned on, the pressure adjusting segment 71 is first extruded, the fluid pressure in the balloon body is increased to 11 atm (p2), and then the control switch 89 is turned off, the pressure adjusting segment 71 is reset to the initial position, at which time the fluid pressure in the balloon body returns to the initial pressure (p1), and p1→p2→p1 is one change. When the change frequency f is 3-500 times / min (preferably 30-200 times / min), and the change duration t is 10 s-30 min (preferably 20 s-10 min), the drug release effect is best, and more drugs reach the vascular lesion site, which makes the bioavailability of the drug higher. The absolute value of the difference between p1 and p2 is denoted as |p1-p2|, and in some cases, 0<|p1-p2|≤16 atm. In some cases, 1 atm<|p1-p2|≤16 atm. In some cases, 2 atm<|p1-p2|≤6 atm.

[0093] Of course, the fluid pressure in the balloon body cavity can also be controlled by the stepping motor 83 to reach p1,..., p n wherein n is an integer, n≥2, p x-1 ≠p x, x is an integer, 2≤x≤n. In some cases, 0<|p x-1 -p x |≤16atm. In some cases, 1atm<|p x-1 -p x |≤16atm. In some cases, 2atm<|p x-1 -p x |≤6atm. The fluid pressure in the balloon lumen changes constantly in the pattern of p1→...→p n →p1 over a period of time. In addition, as in Embodiment 1, each time interval can be divided into two parts in time sequence: a pressure maintaining time interval and a pressure changing time interval, and the change pattern of each time interval is the same as in Embodiment 1. x-1 or t n , each time interval can be divided into two parts in time sequence: a pressure maintaining time interval and a pressure changing time interval, and the change pattern of each time interval is the same as in Embodiment 1.

[0094] When n=3, the change pattern of p1→p2→p3→p1 can be (1) p1<p2<p3; (2) p1<p2, p2>p3, p1=p3; (3) p1<p2, p2>p3, p1<p3; (4) p1<p2, p2>p3, p1>p3; (5) p1>p2>p3; (6) p1>p2, p2<p3, p1=p3; (7) p1>p2, p2<p3, p1<p3; (8) p1>p2, p2<p3, p1>p3. The fluid pressure in the balloon lumen changes constantly in the pattern of p1→p2→p3→p1 over a period of time. When n=2, the change pattern of p1→p2→p1 can be (1) p1<p2; (2) p1>p2.

[0095] In some cases, p1<p2, p1≤p x , 2≤x≤n. At this time, when n=3, the change pattern of p1→p2→p3→p1 can be (1) p1<p2<p3; (2) p1<p2, p2>p3, p1=p3; (3) p1<p2, p2>p3, p1<p3. The fluid pressure in the balloon lumen changes constantly in the pattern of p1→p2→p3→p1 over a period of time; when n=2, the change pattern of p1→p2→p1 can be p1<p2.

[0096] Embodiment 3: A new pulsatile pump The embodiment is a fifth pressure control pump of the application, which is also a new type of pulsating pump. The difference between the embodiment and the embodiment 2 is that a linear motor is used instead of the step motor in the embodiment 2. When the linear motor works, the linear motor drives the working shaft to move linearly in the axial direction. When the working shaft moves linearly in the axial direction towards the fixed block, the connecting member will squeeze the pressure adjusting section, thereby increasing the fluid pressure in the balloon body. When the working shaft moves linearly in the axial direction away from the fixed block, the connecting member will stretch the pressure adjusting section, thereby reducing the fluid pressure in the balloon body.

[0097] The fluid pressure in the balloon body can be controlled to reach p1,...,p n , where n is an integer, n≥2, p x-1 ≠p x , x is an integer, 2≤x≤n. In some cases, 0<|p x-1 -p x |≤16atm. In some cases, 1atm<|p x-1 -p x |≤16atm. In some cases, 2atm<|p x-1 -p x |≤6atm. The fluid pressure in the balloon body changes in the mode of p1→...→p n →p1 over time. In addition, like the embodiment 1, no matter t x-1 or t n , each time interval can be divided into two parts in time sequence: a pressure maintaining time period and a pressure changing time period, and the change mode of each time period is the same as that in the embodiment 1.

[0098] When n=3, the change mode of p1→p2→p3→p1 can be (1) p1<p2<p3; (2) p1<p2, p2>p3, p1=p3; (3) p1<p2, p2>p3, p1<p3; (4) p1<p2, p2>p3, p1>p3; (5) p1>p2>p3; (6) p1>p2, p2<p3, p1=p3; (7) p1>p2, p2<p3, p1<p3; (8) p1>p2, p2<p3, p1>p3. The fluid pressure in the balloon body changes in the mode of p1→p2→p3→p1 over time. When n=2, the change mode of p1→p2→p1 can be (1) p1<p2; (2) p1>p2.

[0099] In some cases, p1<p2, p1≤p x, 2≤x≤n. At this time, when n=3, the change mode of p1→p2→p3→p1 can be (1) p1<p2<p3; (2) p1<p2, p2>p3, p1=p3; (3) p1<p2, p2>p3, p1<p3. The fluid pressure in the balloon lumen is constantly changing in the mode of p1→p2→p3→p1 over a period of time; when n=2, the change mode of p1→p2→p1 can be p1<p2.

[0100] Embodiment 4: A new type of pulsatile pump This embodiment is the sixth pressure control pump of the present application, which is also a new type of pulsatile pump, as shown in Figures 15-20 The difference between this embodiment and the first pressure control pump in Embodiment 1 is that the pressure regulating module further comprises a pressure regulating implementation part 9, which comprises a bottom plate 91, a positioning plate 92, a speed reducer 93, a fixed block 94 and a cover plate 95. The positioning plate 92 is divided into two parts: a flat section 921 and a vertical section 922, which is fixed vertically on the top of the flat section 921, preferably an integrated design. The flat section 921 and the fixed block 94 are fixedly connected to the top of the bottom plate 91, such as the flat section 921 being arranged at one end of the bottom plate 91 and the fixed block 94 being arranged at the opposite end of the bottom plate 91. The vertical section 922 is located between the flat section 921 and the fixed block 94, which can be used to determine the installation position of the speed reducer 93. The speed reducer 93 is arranged on the top of the flat section 921 and fixedly connected with the vertical section 922. A through hole 923 is arranged in the vertical section 922, and a cylindrical cam male head 96 passes through the through hole 923. The base part 961 of the cylindrical cam male head 96, which is connected with one end of the speed reducer 93, is provided with an inwardly recessed connecting channel 962, and the opposite end of the base part 961 is provided with a concave-convex interval structure along the outer periphery. The connecting channel 962 can extend to a part of the inside of the rod-shaped part 963 of the cylindrical cam male head, or can penetrate through the entire rod-shaped part 963. The connecting channel 962 is fixedly connected with the working shaft 97 of the speed reducer 93. The rod-shaped part 963 extends a distance from the middle part of the base part 961 to the fixed block 94, preferably in a cylindrical shape. The rod-shaped part 963 and the base part 961 are preferably an integrated design. The cross-sectional size of the rod-shaped part 963 is smaller than that of the base part 961, but larger than that of the connecting channel 962.

[0101] The fixed block 94 can be divided into a flat portion 941 and a vertical portion 942, the vertical portion 942 being fixed vertically on the top of the flat portion 941, preferably being designed as an integral molding. The flat portion 941 has one end close to the positioning plate 92 for setting the vertical portion 942, and the other end for supporting the cover plate 95. The vertical portion 942 is provided with a through channel 943, preferably located in the middle region of the vertical portion 942. A cylindrical cam head 98 is arranged in the through channel 943 and axially slides a distance along the through channel 943, the length of the cylindrical cam head 98 being equal to or less than the length of the through channel 943, and of course can be greater than the length of the through channel according to needs. One end of the cylindrical cam head 98 is provided with an inwardly recessed connecting channel 981, which can axially slide the rod-shaped portion 963, and the opposite end of the cylindrical cam head 98 is solid, preferably square.

[0102] One end of the connecting channel 981 is also provided with a structure of concave-convex alternately spaced along the outer periphery. The cross-sectional dimension of the cylindrical cam head 98 is greater than the cross-sectional dimension of the through channel 943, which can prevent the cylindrical cam head 98 from being pulled out of the through channel 943. The convex structures 964 and the concave structures 965 on the base portion 961 are spaced apart, the convex structures 982 and the concave structures 983 on the connecting channel 981 are spaced apart, the convex structures 964 and the concave structures 983 are equal in number and can match in shape, and one convex structure 964 corresponds to only one concave structure 983 in space; the concave structures 965 and the convex structures 982 are equal in number and can match in shape, and one concave structure 965 corresponds to only one convex structure 982 in space. This matching can be complete matching, that is, in each pair of matched convex structure and concave structure, the top end of the convex structure and the bottom end of the concave structure are gaplessly matched together, and this matching can also be non-complete matching, that is, in each pair of matched convex structure and concave structure, the top end of the convex structure and the bottom end of the concave structure exist a certain distance interval.

[0103] When the reduction motor 93 is working, at some time, all the convex structures 964 on the cylindrical cam male head 96 match all the concave structures 983 on the cylindrical cam female head 98, and all the concave structures 965 on the cylindrical cam male head 96 match all the convex structures 982 on the cylindrical cam female head 98, at another time, all the convex structures 964 on the cylindrical cam male head 96 align with all the convex structures 982 on the cylindrical cam female head 98, and all the concave structures 965 on the cylindrical cam male head 96 align with all the concave structures 983 on the cylindrical cam female head 98. The matching of all the concave structures 965 on the cylindrical cam male head with all the convex structures 982 on the cylindrical cam female head and the aligning of all the concave structures 965 on the cylindrical cam male head with all the concave structures 983 on the cylindrical cam female head are carried out alternately, and the matching of all the convex structures 964 on the cylindrical cam male head with all the concave structures 983 on the cylindrical cam female head and the aligning of all the convex structures 964 on the cylindrical cam male head with all the convex structures 982 on the cylindrical cam female head are also carried out alternately.

[0104] The cylindrical cam male head 96 and the cylindrical cam female head 98 are structurally separated and are not an independent entity. Since the cylindrical cam male head 96 is fixedly connected with the reduction motor 93, when all the convex structures 964 on the cylindrical cam male head align with all the convex structures 982 on the cylindrical cam female head, the cylindrical cam female head will also slide along the axial direction: when sliding towards the fixed block 94, the cylindrical cam female head will approach and press the connecting pipe 7 located above or below the pressing groove 952; when sliding away from the fixed block, the degree of pressing of the connecting pipe by the cylindrical cam female head is reduced, or even no pressing of the connecting pipe.

[0105] A lateral wall of the vertical portion 942 close to the cover plate 95 is provided with an inwardly recessed transverse groove 944, and a lateral wall of the cover plate 95 close to the vertical portion 942 is provided with an inwardly recessed transverse groove 951, the two transverse grooves are spatially aligned, and are preferably semicircular, when the fixed block and the cover plate are assembled together, the transverse groove 944 and the transverse groove 951 form a complete fixing groove, through which the connecting pipe passes, preferably, the transverse groove 944 and the transverse groove 951 are semicircular, and the two combined together can form a circular fixing groove. The transverse groove 944 is divided into two by the through channel 943 and is located on both sides of the through channel 943.

[0106] The side wall of the cover plate near the vertical portion 942 is further provided with an inwardly recessed extrusion groove 952, which is spatially aligned with the through channel 943, and preferably, the cross-sectional shape and size of the two are completely identical, of course, the cross-sectional size of the extrusion groove 952 can be larger than that of the through channel 943 according to the needs. Preferably, the extrusion groove 952 is located at the middle portion of the side wall of the cover plate near the vertical portion 942. When the depth of the extrusion groove 952 is greater than that of the transverse groove 951, the extrusion groove 952 divides the transverse groove 951 into two, wherein the first segment 951-1 and the second segment 951-2 of the transverse groove 951 are located on both sides of the extrusion groove 952, and the bottom of the extrusion groove 952 is not provided with the transverse groove 951. When the connecting pipe 7 is placed, the connecting pipe 7 is arranged above the transverse groove 951, so as not to be in contact with the bottom of the extrusion groove 952; in order to increase the contact area of the connecting pipe 7 and the transverse groove 951, the depth of the extrusion groove 952 can be less than or equal to that of the transverse groove 951, and the extrusion groove divides the transverse groove 951 on the cover plate into three, wherein the first segment 951-1 and the second segment 951-2 of the transverse groove 951 are located on both sides of the extrusion groove, the third segment 951-3 is located between the first segment and the second segment and is arranged at the bottom of the extrusion groove 952, and the depth of the third segment is less than that of the first segment and the second segment, and is equal to the difference between the depth of the first segment 951-1 or the second segment 951-2 and the depth of the transverse groove 951. Of course, the depth of the third segment can also be less than or greater than the difference between the depth of the first segment 951-1 or the second segment 951-2 and the depth of the transverse groove 951.

[0107] When the deceleration motor is powered, the deceleration motor 93 drives the cylindrical cam male head 96 and the cylindrical cam female head 98 to move axially towards the extrusion groove 952, and the cylindrical cam female head 98 extrudes the connecting pipe fixed above or at the bottom of the extrusion groove 952. The width of the cover plate 95 is greater than the width of the fixed block 94, so that the opposite first end and second end of a side wall of the cover plate 95 connected with the vertical part 942 are exposed from the fixed block 94. At the first end of the side wall of the cover plate 95, two rows of glue injection grooves are arranged: the first upper row of glue injection grooves 953 and the first lower row of glue injection grooves 954, and the first section 951-1 of the transverse groove 951 is located between the two rows of glue injection grooves, and the adjacent glue injection grooves in each row of glue injection grooves are spaced apart, and each row of glue injection grooves is located in the exposed part of the first end of the side wall, facilitating the application of curing glue; at the second end of the side wall of the cover plate 95, two rows of glue injection grooves are arranged: the second upper row of glue injection grooves 955 and the second lower row of glue injection grooves 956, and the second section 951-2 of the transverse groove 951 is located between the two rows of glue injection grooves, and the adjacent glue injection grooves in each row of glue injection grooves are spaced apart, and each row of glue injection grooves is located in the exposed part of the second end of the side wall, facilitating the application of curing glue. The first upper row of glue injection grooves 953 and the second upper row of glue injection grooves 955 are distributed on both sides of the extrusion groove 952 and are spatially aligned, and the first lower row of glue injection grooves 954 and the second lower row of glue injection grooves 956 are distributed on both sides of the extrusion groove 952 and are spatially aligned. The groove direction of each glue injection groove is perpendicular to the transverse groove 951 and terminates at the transverse groove 951. When the connecting pipe 7 passes through the transverse groove 951, curing glue can be injected into each glue injection groove in each row of glue injection grooves to firmly fix the connecting pipe 7 in the transverse groove 951.

[0108] The cover plate 95 and the fixed block 94 are fixedly connected together. In order to fixedly connect the cover plate 95 and the fixed block 94 together, the fixing member 945 can be used to fixedly connect the cover plate 95 and the flat part 941 together, or the fixing member 945 can be used to fixedly connect the cover plate 95 and the vertical part 942 together, and the fixing member 945 can be selected from a screw, a bolt-nut or a stud-nut.

[0109] The part of the bottom plate 91 for supporting the fixing block 94 is provided with a plurality of fixing channels 911 penetrating the upper and lower surfaces of the bottom plate 91, which are preferably parallel to the length direction of the bottom plate 91 or perpendicular to the length direction of the bottom plate 91, and of course, one such fixing channel 911 can also be provided according to needs. At this time, the bottom of the fixing block 94 is provided with a plurality of rows of inwardly recessed fixing holes, the number of rows of fixing holes is the same as the number of fixing channels 911, and only one fixing channel 911 corresponds to each row of fixing holes in space. Each row of fixing holes is provided with at least one fixing hole, for example, three fixing holes are provided at intervals; for each fixing hole, a fixing member 946 can be used to pass through the corresponding fixing channel 911 and be fixedly connected with the fixing hole. When the fixing hole is a hot melt nut, for each fixing hole, a screw can be selected to pass through the corresponding fixing channel 911 of each fixing hole and be fixedly connected with the fixing hole. In addition, the purpose of providing the fixing channel 911 on the bottom plate 91 is also to adjust the distance between the fixing block 94 and the vertical section 922, because according to different specifications of the balloon catheter or according to different fluid pressure control needs in the balloon body, the distance between the two can be adjusted to control the extrusion strength of the cylindrical cam nut 98 on the connecting pipe 7 located above or below the extrusion groove 952.

[0110] The fluid pressure in the balloon body lumen can be controlled to reach p1,...,p n , where n is an integer, n≥2, p x-1 ≠p x , x is an integer, 2≤x≤n. In some cases, 0<|p x-1 -p x |≤16atm. In some cases, 1atm<|p x-1 -p x |≤16atm. In some cases, 2atm<|p x-1 -p x |≤6atm. The fluid pressure in the balloon body lumen is constantly changing in the mode of p1→...→p n →p1over time. In addition, as in Embodiment 1, whether it is t x-1 or t n , each time interval can be divided into two parts in chronological order: a pressure maintaining period and a pressure changing period, and the change mode of each period is the same as in Embodiment 1.

[0111] When n = 3, the change mode of p1→p2→p3→p1 can be (1) p1 < p2 < p3; (2) p1 < p2, p2 > p3, p1 = p3; (3) p1 < p2, p2 > p3, p1 < p3. The fluid pressure in the balloon lumen changes continuously in the mode of p1→p2→p3→p1 over time. When n = 2, the change mode of p1→p2→p1 can be (1) p1 < p2; (2) p1 > p2.

[0112] In some cases, p1 < p2, p1 ≤ p x 2 ≤ x ≤ n. At this time, when n = 3, the change mode of p1→p2→p3→p1 can be (1) p1 < p2 < p3; (2) p1 < p2, p2 > p3, p1 = p3; (3) p1 < p2, p2 > p3, p1 < p3. The fluid pressure in the balloon lumen changes continuously in the mode of p1→p2→p3→p1 over time; when n = 2, the change mode of p1→p2→p1 can be p1 < p2.

[0113] Embodiment 5: A new balloon catheter The balloon catheter in Embodiment 5 is different from Embodiment 1 in that the light generating device including the light source is not located outside the balloon catheter, but at least one LED light source is arranged in the balloon lumen or inner wall, and then the LED light source is connected with the control circuit located outside the balloon catheter through the optical fiber lumen interface (at this time, it should be called LED wire interface). When the LED light source needs to emit light, pressing the on-off switch in the control circuit can make the LED light source emit light of a specific wavelength range, and when the LED light source does not need to emit light, pressing the on-off switch again can turn off the LED light source.

[0114] Embodiment 6: A new balloon catheter The balloon catheter in Embodiment 6 is different from Embodiment 1 in that, since some drugs loaded on the surface of the balloon body can play a role after being released to the lesion site without the need for activation of the drugs, the optical fiber and the light generating module are not required to be arranged.

[0115] Embodiment 7: A new balloon catheter The balloon catheter in Embodiment 7, like Embodiment 1, is different in that the light generating device including the light source is not located outside the balloon catheter, but at least one LED light source is arranged in the balloon lumen or inner wall, and then the LED light source is connected with the control circuit located outside the balloon catheter through the optical fiber lumen interface (at this time, it should be called LED wire interface). When the LED light source needs to emit light, pressing the on-off switch in the control circuit can make the LED light source emit light of a specific wavelength range, and when the LED light source does not need to emit light, pressing the on-off switch again can turn off the LED light source. Figure 6As shown, the difference from Example 1 is that the drug is not coated on the surface of the balloon body in the form of a coating. Instead, the drug is added to the liquid that expands the balloon body. A drug delivery device (such as syringe 170) is connected to the fluid injection interface 141, allowing the drug-containing liquid to flow into the inner cavity 120 of the balloon body through the fluid cavity 138, which communicates with the inner cavity 120 of the balloon body. Then, it flows out of the balloon body 110 through pores in the balloon wall, thereby reaching the vascular lesion site, thus enabling the drug to exert its therapeutic effect. When the drug does not require light activation, the optical fiber and light generation module are also unnecessary.

[0116] Example 8: A novel balloon catheter like Figures 7-9 As shown, the provided balloon catheter 200 is a papillary balloon catheter, comprising a balloon body 210 and a tubular body 230. The balloon body 210 includes a balloon wall 211, which defines an inner lumen 212. Multiple radially outwardly oriented papillary points 220 are distributed on the outer surface of the balloon body 210. The papillary points 220 can be fixed to the outer surface of the balloon wall 211 by means of bonding or other methods, and are generally made of polyurethane or silicone material. The balloon body 210 has a distal end 201 and a proximal end 202 along the axial direction.

[0117] The papillae 220 have a radially raised height H relative to the outer surface of the capsule wall 211, where H is 0.05–0.50 mm, for example, 0.05–0.30 mm. There are multiple papillae 220, for example, 3–8 groups spaced apart along the circumference of the capsule body, with each group containing 3–20 protrusions spaced apart along the axial direction of the capsule body. The papillae 220 are spherical or ellipsoidal, for example, hemispherical, with a hemispherical diameter of 0.12–0.80 mm. Along the circumference of the capsule body, the distance L between two adjacent groups of protrusions is 0.5–6 times the height H of the protrusion, preferably 2–4 times. In some cases, the distance between adjacent protrusions within the same group is also L.

[0118] The tube 230 is used to inject fluid into the inner cavity 212 of the balloon body 210, causing the balloon body 210 to inflate. After use, the fluid is discharged, and the balloon body 210 collapses or folds to facilitate recovery.

[0119] The tube body 230 can be a single tube or include multiple tubes. For example, the tube body 230 includes an inner tube 232 and an outer tube 231. The inner tube 232 is axially oriented and serves as a fluid cavity 237 for guide wire insertion during interventional delivery. The balloon body 210 is located on the outer periphery of the inner tube 232, and the distal end of the balloon body 210 is sealed to the outer wall of the inner tube 232.

[0120] The outer tube 231 is sleeved on the outside of the inner tube 232, the proximal end of the balloon body 210 is butted against the distal end of the outer tube 231, and the radial gap between the outer tube 231 and the inner tube 232 is a fluid cavity 238 in communication with the inner cavity 212, and the fluid can be injected into and inflate the balloon body 210 through the fluid cavity 238.

[0121] When treating vascular stenosis lesions such as vascular plaque and calcified lesions, the pressure is accumulated on the papillary point 220 when the balloon body 210 is expanded, which increases the friction between the balloon body 210 and the blood vessel wall, and promotes the fragmentation of the vascular plaque and calcified lesion site. When the balloon catheter 200 is equipped with any one of the pressure control pumps in embodiments 1-4, the three-way valve 6 of the pressure control pump can be connected in fluid communication with the fluid cavity 238 through the connecting tube 7. Then by operating the pressure control pump, the pressure of the fluid is constantly changed in the mode of p1→p2→p1, and at the same time, the balloon body 210 also follows the change rule of expansion→contraction→expansion according to the pressure change mode of the fluid, so that the papillary point 220 protruding on the surface of the balloon body 210 periodically rubs the lesion site, which can better promote the fragmentation of the vascular plaque and calcified lesion site.

[0122] Of course, the fluid pressure in the balloon body cavity can also be adjusted by the pressure control pump to reach p1,...,p n , where n is an integer, n≥2, p x-1 ≠p x , x is an integer, 2≤x≤n. In some cases, 0<|p x-1 -p x |≤16atm. In some cases, 1atm<|p x-1 -p x |≤16atm. In some cases, 2atm<|p x-1 -p x |≤6atm. The fluid pressure in the balloon body cavity is constantly changed in the mode of p1→...→p n →p1 within a period of time. In addition, as in embodiment 1, whether it is t x-1 or t n , each time interval can be divided into two parts in time sequence: a pressure maintaining time period and a pressure changing time period, and the change mode of each time period is the same as that in embodiment 1.

[0123] When n = 3, the change pattern of p1 → p2 → p3 → p1 can be: (1) p1 < p2 < p3; (2) p1 < p2, p2 > p3, p1 = p3; (3) p1 < p2, p2 > p3, p1 < p3; (4) p1 < p2, p2 > p3, p1 > p3; (5) p1 > p2 > p3; (6) p1 > p2, p2 < p3, p1 = p3; (7) p1 > p2, p2 < p3, p1 < p3; (8) p1 > p2, p2 < p3, p1 > p3. The fluid pressure in the inner cavity of the balloon continuously changes according to the pattern of p1 → p2 → p3 → p1 over a period of time. When n = 2, the change pattern of p1 → p2 → p1 can be: (1) p1 < p2; (2) p1 > p2.

[0124] In some cases, p1 < p2, p1 ≤ p x , 2 ≤ x ≤ n. At this time, when n = 3, the change pattern of p1 → p2 → p3 → p1 can be: (1) p1 < p2 < p3; (2) p1 < p2, p2 > p3, p1 = p3; (3) p1 < p2, p2 > p3, p1 < p3. The fluid pressure in the inner cavity of the balloon continuously changes according to the pattern of p1 → p2 → p3 → p1 over a period of time; when n = 2, the change pattern of p1 → p2 → p1 can be p1 < p2.

[0125] Example 9: A new type of balloon catheter The balloon catheter 300 of this example can select the constrained balloon dilation catheter in Chinese Patent CN102939125B, as Figure 10 shown. The difference between it and Example 3 is that multiple axially spaced apart axial columns 301 and multiple axially spaced apart radially expandable rings 302 are provided on the balloon body 310, and each axial column 301 is cross - attached to each radially expandable ring 302. These axial columns 301 and these radially expandable rings 302 together form an approximately cylindrical cage - like structure. When the balloon body 310 expands, the radially expandable rings 302 expand, but the maximum expansion diameter of the radially expandable rings 302 is less than the maximum expansion diameter of the balloon body 310. Therefore, when the balloon body 310 is fully expanded, under the constraint of the radially expandable rings 302, pillow - like parts 303 and grooves 304 are distributed at intervals on the outer surface of the balloon body 310. The axial columns 301 and the radially expandable rings 302 can be made of materials such as wire (such as nitinol wire) or nylon. One end of each axial column 301 is connected to the distal end of the balloon body 310 or the inner or outer wall of the tube body 330 near the distal end of the balloon body 310 by a fixed connection or other connection methods, and the other end is connected to the proximal end of the balloon body 310 or the inner or outer wall of the tube body 330 near the distal end of the balloon body 310 by a fixed connection or other connection methods. When the drug is not needed, the drug coating in Example 3 can be removed.

[0126] The present application finds that when the balloon catheter 300 is equipped with any one of the pressure control pumps in embodiments 1-4, the three-way valve 6 of the pressure control pump can be connected in fluid communication with the fluid injection interface of the tube body 330 through the connecting tube 7. Then repeatedly rotate the knob 4, so that the pressure of the fluid is constantly changing in the mode of p1→p2→p1, and at the same time, the balloon body 310 also follows the change rule of expansion→contraction→expansion according to the pressure change mode of the fluid, so that the pillow part 303 of the balloon body 310 is periodically attached and extruded to the lesion site (such as atherosclerotic plaque), which can better promote plaque remodeling and reduce damage to the vascular endothelium. In addition, when the balloon body 310 has a drug coating on the outer surface, the balloon body 310 follows the change rule of expansion→contraction→expansion, which also promotes drug release, and more drugs are released to the vascular lesion site.

[0127] Of course, the fluid pressure in the balloon cavity can also be adjusted by rotating the knob 4 to reach p1,...,p n , where n is an integer, n≥2, p x-1 ≠p x , x is an integer, 2≤x≤n. In some cases, 0<|p x-1 -p x |≤16atm. In some cases, 1atm<|p x-1 -p x |≤16atm. In some cases, 2atm<|p x-1 -p x |≤6atm. The fluid pressure in the balloon cavity is constantly changing in the mode of p1→...→p n →p1 over time. In addition, as in embodiment 1, whether it is t x-1 or t n , each time interval can be divided into two parts in chronological order: a pressure maintenance period and a pressure change period, and the change mode of each period is the same as in embodiment 1.

[0128] When n = 2, the change mode of p1→p2→p1 can be (1) p1 < p2; (2) p1 > p2. When n = 3, the change mode of p1→p2→p3→p1 can be (1) p1 < p2 < p3; (2) p1 < p2, p2 > p3, p1 = p3; (3) p1 < p2, p2 > p3, p1 < p3. The fluid pressure in the balloon lumen is constantly changing in the mode of p1→p2→p3→p1 over time.

[0129] In some cases, p1 < p2, p1 ≤ p x , 2 ≤ x ≤ n. At this time, when n = 3, the change mode of p1→p2→p3→p1 can be (1) p1 < p2 < p3; (2) p1 < p2, p2 > p3, p1 = p3; (3) p1 < p2, p2 > p3, p1 < p3. The fluid pressure in the balloon lumen is constantly changing in the mode of p1→p2→p3→p1 over time; when n = 2, the change mode of p1→p2→p1 can be p1 < p2.

[0130] Example 10: Detection of drug release amount The balloon catheter in Example 1 of the present application is taken as the experimental object, and a silica gel tube is taken as the model blood vessel to carry out the experiment, wherein the drug coating of the balloon catheter contains paclitaxel and BTHC, and the fluid used for balloon body expansion is water.

[0131] Drug coating preparation method: a proper amount of BTHC is dissolved in acetone, a proper amount of paclitaxel is added, dissolved, the concentration of the dissolved paclitaxel is 10-30 mg / ml, the concentration of BTHC is 1-10 mg / ml, then mixed, coated on the balloon, dried, and wound to obtain. In the prepared drug coating, the paclitaxel dose is 1-10 μg / mm 2 . For the convenience of description, in Example 1, the concentration of the dissolved paclitaxel is 25 mg / ml, and the concentration of BTHC is 2.5 mg / ml; in the prepared drug coating, the paclitaxel dose is 2.4 μg / mm 2 The specific experiment is carried out.

[0132] The experimental group is the balloon catheter containing the pressure control pump, the balloon body is filled to 12 atm by the pressure control pump, the fluid pressure is changed in the mode of 12 atm (p1)→8 atm (p2)→12 atm (p1) by repeatedly rotating the knob, the change frequency is 30 times / min, the change duration is 1 min, n = x = 2, t m1=t m 2=10ms, t1=t2, for p1→p2, 9.6atm≤fluid pressure of each peak between p1 and p2≤11.2atm, 9.6atm≤fluid pressure of each trough between p1 and p2≤11.2atm; for p2→p1, 9.6atm≤fluid pressure of each peak between p2 and p1≤11.2atm, 9.6atm≤fluid pressure of each trough between p2 and p1≤11.2atm, 3 groups in parallel. The control group is a balloon catheter without a pressure control pump, the balloon body is inflated to 12atm and kept constant, 3 groups in parallel. The balloon catheters used in the experimental group and the control group belong to the same batch of balloon catheters.

[0133] The experimental process is to extend the drug-coated balloon into a silica gel tube (the silica gel tube itself is placed in a glass test tube) with appropriate amount of water, inflate the balloon body to 12atm with the inflation pump, and the fluid pressure in the experimental group and the control group changes according to the respective change mode, and keeps for 1min, in this process, the drug is released into the aqueous solution (release process), and the balloon in the experimental group and the control group is taken out after pressure relief. Then put each balloon taken out into a test tube with 4mL acetonitrile, until the drug remaining on each balloon is completely dissolved in the acetonitrile solution (residual process), shake well, and then measure the residual drug content (recorded as residual amount). The aqueous solution in the release process is filtered with a 0.22μm filter head, and 4ml acetonitrile is used to rinse the glass test tube to obtain acetonitrile rinse liquid, and the filtered filter head is immersed in the acetonitrile rinse liquid until the drug on the filter head is completely dissolved in the acetonitrile, which is marked as the drug released into water (referred to as water); the silica gel tube in the release process is rinsed with 4ml acetonitrile until the drug is completely dissolved in acetonitrile, which is marked as the drug released onto the silica gel tube (referred to as tube), and the drug content is measured. The experimental results are shown in the following table.

[0134]

[0135] As can be seen from the table, compared with the control group (26.90%), the average drug residue of the experimental group is significantly reduced to 19.80%, and the reduction rate is as high as (26.90%-19.80%) / 26.8%, that is, 26.40%. Even if the two-by-two comparison is carried out between the control group and the experimental group, the lowest reduction rate of the average drug residue is 12.76%. In addition, since the silica gel tube is used as a blood vessel model, the drug released on the silica gel tube will act on the blood vessel lesion site, and the drug released from the silica gel tube into the water will be washed away by the blood in the real blood vessel, so it will not play a role in the blood vessel lesion site. Therefore, it is more meaningful to compare the drug content released on the silica gel tube in the control group and the experimental group. After comparison, compared with the control group (66.68%), the average drug content released on the silica gel tube in the experimental group is significantly increased to 76.14%, and the increase rate is as high as 14.2%. Therefore, the technical scheme of the present application not only can significantly improve the drug release amount, but also more drugs are released on the silica gel tube as a blood vessel model, which means that more drugs reach the blood vessel lesion site during actual use, thereby better playing a therapeutic effect.

[0136] When the second pressure control pump, the third pressure control pump, the fourth pressure control pump, the fifth pressure control pump or the sixth pressure control pump in embodiments 1-4 is used to replace the first pressure control pump in embodiment 1 to adjust the fluid pressure in the balloon body, more drugs can be significantly promoted to be released, and more drugs are released on the silica gel tube as a blood vessel model.

[0137] The above-described embodiments only express several embodiments of the present application, and the description is more specific and detailed, but it should not be understood as limiting the scope of the application. It should be noted that for ordinary skilled persons in the art, without departing from the concept of the present application, several modifications and improvements can be made, which are all within the protection scope of the present application. Therefore, the patent protection scope of the present application should be subject to the appended claims.

Claims

1. A pressure regulating system, characterized by, The pressure regulating system comprises: A medical device provided with a lumen and a fluid injection port in fluid communication; A pressure control pump is provided with a fluid communicating part in fluid communication with the inner cavity of the medical device and the fluid injection interface, and after injecting fluid into the inner cavity of the medical device and the fluid communicating part, the pressure regulating module is controlled to allow the fluid pressure in the inner cavity of the medical device to reach p1,...,p n , where n is an integer, n≥2, p x-1 ≠p x , x is an integer, 2≤x≤n, and allow the fluid pressure in the inner cavity of the medical device to repeatedly change according to the change mode of p1→...→p n →p1 in a period of time t.

2. The pressure regulating system of claim 1, wherein, The medical device is a balloon catheter comprising a tube and a balloon, the lumen of the medical device is the lumen of the balloon, the tube has opposite distal and proximal ends and is provided with a fluid lumen, the balloon is provided on the outer periphery of the distal end of the tube, the lumen of the balloon is in communication with the fluid lumen, and the fluid injection port of the medical device is provided on the proximal end of the tube and is in communication with the fluid lumen.

3. The pressure regulating system of claim 1, wherein, 0 < |p x-1 -p x |≤16atm, preferably, 1 atm < |p x-1 -p x |≤16atm, more preferably, 2 atm < |p x-1 -p x |≤6atm.

4. The pressure regulating system of claim 1, wherein, For any two adjacent p x-1 and p x , the time interval of p x-1 →p x is denoted as t x-1 ; for p n and p1, the time interval of p n →p1 is denoted as t n , t x-1 can be divided into a pressure maintaining time period t m x-1 and a pressure changing time period t c x-1 in time sequence, t n can be divided into a pressure maintaining time period t m n and a pressure changing time period t c n in time sequence, t m x-1 ≥ 10 ms and t m n ≥ 10 ms.

5. The pressure regulating system of claim 4, wherein, t m x-1 =t m n and t c x-1 =t c n , or, ∑t x-1 (x=2,..., n)=t n .

6. The pressure regulating system of claim 4, wherein, At t c x-1 and t c n The pressure variation pattern between p x-1 → p x and p n → p1is selected from one of the following patterns: (1) a linear variation pattern, (2) a non-linear variation pattern with peaks and valleys occurring at intervals, for p x-1 → p x , the fluid pressure at each peak between min(p x-1 , p x ) and p x-1 and p x is < max(p x-1 , p x ), the fluid pressure at each valley between min(p x-1 , p x ) and p x-1 and p x is < max(p x-1 , p x ); for p n → p1, the fluid pressure at each peak between min(p n , p1) and p n and p1is < max(p n , p1), the fluid pressure at each valley between min(p n , p1) and p n and p1is < max(p n , p1).

7. The pressure regulating system of claim 1, wherein, p1→...→p n →p1 is a change in one, the change frequency f is 3-500 times / min, t is 10s-30min, preferably, f is 30-200 times / min, t is 20s-10min.

8. The pressure regulating system of claim 1, wherein, When n=2, p1 9. The pressure regulating system of claim 2, wherein, The balloon is loaded with a drug, and the drug is coated on the outer surface of the balloon in the form of a coating.

10. A method of regulating fluid pressure in a lumen of a medical device, characterized by, The method comprises: Delivering at least a portion of a medical device in fluid communication with a pressure control pump to a target site in or near a subject, the medical device being provided with a lumen and a fluid injection port in fluid communication, the pressure control pump being provided with a fluid communication portion in fluid communication with the lumen and the fluid injection port of the medical device; After the lumen and fluid communicating part of the medical device is filled with fluid, the pressure regulating module is operated to make the fluid pressure in the lumen of the medical device reach p1,...,p n , where n is an integer, n≥2, p x-1 ≠p x , x is an integer, 2≤x≤n, and the fluid pressure in the lumen of the medical device is repeatedly changed according to the change mode of p1→...→p n →p1 in a time period t.

Images