CN119701167A - Balloon catheter - Google Patents

Abstract

The invention relates to a balloon catheter which is characterized by comprising a balloon, a catheter, a tail end pipe, a developing ring, a catheter seat, a stress pipe and a catheter sleeve, wherein the catheter comprises an inner pipe and an outer pipe, the outer pipe is sleeved outside the inner pipe, the distal end of the inner pipe is connected with the proximal end of the tail end pipe, the distal end of the balloon is fixed on the outer surface of the tail end pipe and/or the outer surface of the inner pipe, the proximal end of the balloon is fixed on the outer surface of the distal end of the outer pipe, the developing ring is arranged on the inner pipe in the balloon, the stress pipe is fixed at the distal end of the catheter seat, the proximal end of the inner pipe penetrates through the stress pipe and the catheter seat to be fixed inside the proximal end of the catheter seat, the proximal end of the outer pipe penetrates through the stress pipe and the catheter seat to be fixed inside the distal end of the catheter seat, and the catheter sleeve is sleeved outside the balloon. The balloon catheter can effectively solve the treatment of arterial or venous stenosis and other lesions.

Description

Balloon catheter

Technical Field

The invention relates to the field of interventional medicine, in particular to a balloon catheter.

Background

Peripheral vascular disease includes diseases of the arterial and venous systems, which are usually caused by deposits (plaques) containing fat and cholesterol adhering to the walls of arterial blood vessels, a process known as atherosclerosis, which causes arterial stenosis, resulting in a decrease in blood flow through the arteries. Atherosclerosis involves systemic arterial blood vessels and can cause peripheral arterial disease if the arteries supplying blood to the extremities develop atherosclerosis. The upper and lower limbs of the patient with Peripheral Arterial Disease (PAD) have insufficient blood supply (commonly found in lower limbs) and cannot meet the body requirements, which may cause symptoms such as pain in the upper limbs, pain in leg muscles during walking, cramp of leg, difficulty in walking and the like. Pain may also occur during rest or lying down, which may interrupt sleep if peripheral arterial disease is exacerbated. At the same time, plaque build-up in arteries can also affect blood vessels in the heart and brain, causing strokes and heart attacks. Venous diseases typically include venous compression syndrome, deep vein thrombosis, and the like.

Thus, there is a need for medical devices suitable for percutaneous transluminal angioplasty of the peripheral vascular system, including the iliac arteries and iliac femoral veins, and for the treatment of obstructive lesions of autologous or artificial arteriovenous dialysis fistulae.

Disclosure of Invention

In order to overcome the problems in the prior art, the invention provides a balloon catheter.

In some embodiments of the present invention, the balloon catheter comprises a balloon, a catheter, a tip tube, a catheter seat and a stress tube, wherein the catheter comprises an inner tube and an outer tube, the outer tube is sleeved outside the inner tube, the distal end of the inner tube is connected with the proximal end of the tip tube, the distal end of the balloon is fixed on the outer surface of the tip tube and/or the inner tube, the proximal end of the balloon is fixed on the outer surface of the distal end of the outer tube, the stress tube is arranged at the distal end of the catheter seat, the proximal end of the inner tube passes through the stress tube and the catheter seat and then is fixed inside the proximal end of the catheter seat, and the proximal end of the outer tube passes through the stress tube and the catheter seat and then is fixed inside the distal end of the catheter seat.

In some embodiments of the invention, the outer diameter of the stress tube gradually decreases from the proximal end to the distal end, and the outer surface of the stress tube is provided with a plurality of alternating continuous depressions comprising annular depressions circumferentially disposed about the stress tube, and intermittent depressions comprising at least one circumferential depression section circumferentially disposed along the stress tube.

In some embodiments of the present invention, the balloon comprises a first layer and a second layer, the second layer is disposed near the inner tube, the first layer is disposed on a surface of the second layer far away from the inner tube, the first layer is made of nylon 12, the second layer is made of pebax, and a mass ratio of the first layer to the second layer ranges from 6/4 to 8/2.

In some embodiments of the invention, the balloon comprises a first straight line segment, a first transition segment, a second straight line segment, a second transition segment, and an inflation body portion, the first straight line segment being secured to the outer surface of the tip tube and/or the inner tube, the proximal end of the first straight line segment being connected to the distal end of the first transition segment, the proximal end of the first transition segment being connected to the distal end of the inflation body portion, the second straight line segment being secured to the outer surface of the outer tube, the distal end of the second straight line segment being connected to the proximal end of the second transition segment, the distal end of the second transition segment being connected to the proximal end of the inflation body portion.

In some embodiments of the present invention, the diameter of the first transition section gradually increases from the distal end to the proximal end, the diameter of the second transition section gradually increases from the proximal end to the distal end, and the balloon catheter further includes two developing rings, one of which is disposed at a position of the inner tube corresponding to the connection of the first transition section to the expansion main body portion, and the other of which is disposed at a position of the inner tube corresponding to the connection of the second transition section to the expansion main body portion.

In some embodiments of the present invention, the inner surface of the outer tube and the outer surface of the inner tube together define an annular cavity, the lumen of the balloon is in communication with the annular cavity, the catheter hub proximal end is provided with a guidewire port in communication with the lumen of the inner tube and a filling port in communication with the annular cavity.

In some embodiments of the present invention, a ratio of a gap between the inner tube and the outer tube to an opening size of the filling port near an end of the catheter is 1:8.8-1:3.6, and a ratio of an opening size of the filling port near an end of the catheter to an opening size of the filling port far from the end of the catheter is 1:2.5-1:1.81.

In some embodiments of the present invention, the distal end of the catheter seat protrudes to the distal end to form a step structure, a first dispensing hole and a second dispensing hole are provided on the catheter seat, the first dispensing hole is provided on the step structure, the first dispensing hole penetrates to the outer surface of the outer tube, the second dispensing hole is provided on the catheter seat, the second dispensing hole penetrates to the outer surface of the inner tube, and the second dispensing hole is located between one end of the filling port close to the catheter and one end of the wire guiding port close to the catheter.

In some embodiments of the present invention, the ratio of the distance of the first dispensing hole from the distal end surface of the step structure to the length of the step structure in the axial direction is 2/5-3/5, and the ratio of the distance of the second dispensing hole from the distal end surface of the step structure to the length of the catheter hub in the axial direction is 2/5-3/5.

In some embodiments of the invention, the tip tube has a hardness less than the inner tube and the outer tube, and the ratio of the hardness of the tip tube to the hardness of the inner tube or the outer tube is in the range of 1:1.1-1:1.6.

The balloon catheter of the present invention has the advantages of being effective in treating peripheral vascular system diseases, including percutaneous transluminal angioplasty of iliac arteries and iliac femoral veins, and obstructive lesions for autologous or artificial arteriovenous dialysis fistulae, etc. The balloon has the characteristics of high burst pressure, good retractive performance and the like, and the diameter of the balloon after the flap is compressed is smaller, so that the damage to blood vessels and the damage to human bodies can be reduced. The setting of the spot gluing hole position can also skillfully avoid the situation that the guide wire port, the filling port or the annular cavity is blocked.

Drawings

Fig. 1 is a schematic perspective view of a balloon catheter according to an embodiment of the present invention.

Fig. 2 is a schematic perspective structural view of a balloon catheter according to an embodiment of the present invention.

Fig. 3 is a schematic perspective view of a stress tube of a balloon catheter according to an embodiment of the present invention.

Fig. 4 is a schematic cross-sectional view of a balloon catheter according to an embodiment of the present invention.

Fig. 5 is a schematic view of a balloon structure of a balloon catheter according to an embodiment of the present invention.

Fig. 6 is a schematic view of a catheter hub of a balloon catheter according to an embodiment of the present invention.

Fig. 7 is a schematic cross-sectional view of a balloon catheter according to an embodiment of the present invention.

The figure shows that 100 parts of balloon catheter, 1 part of balloon, 2 parts of catheter, 3 parts of terminal tube, 4 parts of developing ring, 5 parts of catheter seat, 6 parts of stress tube, 7 parts of catheter sleeve, 21 parts of inner tube, 22 parts of outer tube, 11 parts of first layer, 12 parts of second layer, 13 parts of first straight line segment, 14 parts of first transition segment, 15 parts of second straight line segment, 16 parts of second transition segment, 17 parts of expanding main body part, 131 parts of first matching part, 151 parts of second matching part, 211 parts of annular cavity, 18 parts of inner cavity, 51 parts of guide wire port, 52 parts of filling port, 53 parts of step structure, 531 parts of clamping part, 54 parts of first adhesive dispensing hole, 55 parts of second adhesive dispensing hole, 61 parts of continuous concave part, 62 parts of discontinuous concave part, 611 parts of annular concave part, 621 parts of circumferential concave part.

Detailed Description

Exemplary embodiments of the present invention will be described in more detail below with reference to the accompanying drawings. While exemplary embodiments of the present invention are shown in the drawings, it should be understood that the present invention may be embodied in various forms and should not be limited to the embodiments set forth herein. Rather, these embodiments are provided so that this disclosure will be thorough and complete, and will fully convey the scope of the invention to those skilled in the art.

It is to be understood that the terminology used herein is for the purpose of describing particular example embodiments only, and is not intended to be limiting. As used herein, the singular forms "a", "an" and "the" are intended to include the plural forms as well, unless the context clearly indicates otherwise. The terms "comprises," "comprising," "includes," "including," and "having" are inclusive and therefore specify the presence of stated features, steps, operations, elements, and/or components, but do not preclude the presence or addition of one or more other features, steps, operations, elements, components, and/or groups thereof. The method steps, processes, and operations described herein are not to be construed as necessarily requiring their performance in the particular order described or illustrated, unless an order of performance is explicitly stated. It should also be appreciated that additional or alternative steps may be used.

Although the terms first, second, third, etc. may be used herein to describe various elements, components, regions, layers and/or sections, these elements, components, regions, layers and/or sections should not be limited by these terms. These terms may be only used to distinguish one element, component, region, layer or section from another region, layer or section. Terms such as "first," "second," and other numerical terms when used herein do not imply a sequence or order unless clearly indicated by the context. Thus, a first element, component, region, layer or section discussed below could be termed a second element, component, region, layer or section without departing from the teachings of the example embodiments.

For ease of description, spatially relative terms, such as "inner," "outer," "lower," "below," "upper," "above," and the like, may be used herein to describe one element or feature's relationship to another element or feature as illustrated in the figures. Such spatially relative terms are intended to encompass different orientations of the device in use or operation in addition to the orientation depicted in the figures. For example, if the device in the figures is turned over, elements described as "below" or "beneath" other elements or features would then be oriented "above" or "over" the other elements or features. Thus, the example term "below" may include both upper and lower orientations. The device may be otherwise oriented (rotated 90 degrees or in other directions) and the spatial relative relationship descriptors used herein interpreted accordingly.

For purposes of more clarity in describing the structure of the present application, the terms "proximal" and "distal" are defined herein as terms commonly used in the interventional medical arts. Specifically, "distal" means an end far from the operator during a surgical operation, "proximal" means an end near the operator during a surgical operation, "axial" means a length direction thereof, and "radial" means a direction perpendicular to the "axial".

Referring to fig. 1 and 2, the present invention provides a balloon catheter 100, which balloon catheter 100 is particularly suitable for percutaneous transluminal angioplasty of peripheral vascular systems, including iliac arteries and iliac femoral veins, and for the treatment of obstructive lesions for autologous or artificial arteriovenous dialysis fistulae, and is also suitable for post-expansion of stents and stent grafts in peripheral blood vessels. The balloon catheter 100 comprises a balloon 1, a catheter 2, a tail end tube 3, a developing ring 4, a catheter seat 5, a stress tube 6 and a catheter sleeve 7, wherein the catheter 2 comprises an inner tube 21 and an outer tube 22, the outer tube 22 is sleeved outside the inner tube 21, and the inner tube 21 and the outer tube 22 are coaxially arranged. The distal end of the inner tube 21 is connected to the proximal end of the tip tube 3, the tip tube 3 is coaxially disposed with the inner tube 21, and the tip tube 3 is in communication with the lumen of the inner tube 21. The distal end of the balloon 1 is fixed to the outer surface of the tip tube 3 and/or the inner tube 21, and in the specific embodiment of the present invention, a part of the distal end of the balloon 1 is fixed to the outer surface of the tip tube 3, a part of the distal end is fixed to the outer surface of the inner tube 21, and the proximal end of the balloon 1 is fixed to the outer surface of the distal end of the outer tube 22. The developing ring 4 is arranged on the inner tube 21 in the balloon 1, the stress tube 6 is fixed at the distal end of the catheter seat 5, and the proximal end of the inner tube 21 passes through the stress tube 6 and the catheter seat 5 is fixed inside the proximal end of the catheter seat 5. The proximal end of the outer tube 22 passes through the stress tube 6 and the catheter seat 5 to be fixed inside the distal end of the catheter seat 5, and the catheter sleeve 7 is sleeved outside the balloon 1.

It will be appreciated that the distal end of the balloon 1 is fixed to the outer surface of the tip tube 3 and the outer surface of the inner tube 21, so that the inner tube 21 and the tip tube 3 can be connected more firmly, and the tip tube 3 and the inner tube 21 can be prevented from being disconnected. Meanwhile, in the embodiment of the present invention, the connection between the inner tube 21 and the end tube 3 is hot air welding, so that a part of the distal end of the balloon 1 is fixed on the outer surface of the end tube 3, and a part of the distal end of the balloon is fixed on the outer surface of the inner tube 21, so that the welding trace between the inner tube 21 and the end tube 3 can be covered, and the overall appearance of the balloon catheter 100 is ensured. The developing ring 4 is fixed on the inner tube 21 in the balloon 1, so as to facilitate in vivo observation and positioning of the balloon 1. The stress tube 6 is of a truncated cone structure, the outer diameter of the stress tube 6 is gradually reduced from the proximal end to the distal end, the part, close to the catheter seat 5, of the catheter 2 is easy to bend to cause damage to the catheter 2, the stress tube 6 can play a certain fixing role on the part, close to the catheter seat 5, of the catheter 2, large-angle bending is avoided, and damage to the catheter 2 after bending is avoided. Further, a flap (not shown) is provided on the balloon 1, and the flap is in the prior art and will not be described herein. The catheter sheath 7 is sleeved on the balloon 1 when the balloon catheter 100 is not in use, and the catheter sheath 7 needs to be removed from the balloon 1 when the balloon catheter 100 needs to be used. The catheter hub 7 protects the balloon 1 and also maintains the shape of the flaps when the balloon catheter 100 is not in use, avoiding flap lifting. Hydrophilic coatings are provided on the outer surface of the tip tube 3, the outer surface of the balloon 1, and the outer surface of the outer tube to ensure smoothness of the balloon catheter 100 passing in the body.

Further, the balloon catheter 100 is operated by confirming information such as a stenosis position, a diameter, a length, etc. by contrast, and then selecting the balloon catheter 100 of a corresponding specification. Then, the sheath is firstly placed in the catheter to establish a channel, and the guide wire is placed in the catheter to establish a track. The balloon catheter 100 is then advanced from outside along this path and track until the distal end of the balloon catheter 100 passes over the stenosis (aligning the balloon 1 with the stenosis). The balloon 1 is then inflated by applying pressure to the balloon catheter 100 using a pressure inflation instrument. The balloon 1 is expanded and then pressed against the stenosed segment, so that atheromatous substances, arterial plaque, etc. in the stenosed segment are pressed and deformed and then attached to the inner wall of the blood vessel. Further expanding the balloon 1, tearing the smooth muscle of the vessel wall properly, and further expanding the vessel and its lumen. After a period of time (about tens of seconds to minutes), balloon 1 is de-pressurized and withdrawn along the guidewire and passageway. At this time, the lumen of the narrow section of the blood vessel is enlarged, and the good blood circulation function is restored.

Referring to fig. 3, the outer surface of the stress tube 6 is provided with a plurality of continuous recesses 61 and intermittent recesses 62 alternately, the continuous recesses 61 include annular recesses 611 circumferentially disposed around the stress tube, and the intermittent recesses 62 include at least one circumferential Xiang Aoxian segment 621 circumferentially disposed along the stress tube 6. Specifically, the annular recess 611 is a closed annular recess formed by recessing inward on the outer surface of the stress tube 6, and the circumferential recess 621 is a small recess formed by recessing inward on the outer surface of the stress tube 6. The alternating arrangement of the continuous concave portions 61 and the intermittent concave portions 62 is understood as that one continuous concave portion 61 is connected to one intermittent concave portion 62, the intermittent concave portion 62 is connected to another continuous concave portion 61, another continuous concave portion 61 is connected to another intermittent concave portion 62, and so on, the continuous concave portions 61 and the intermittent concave portions 62 are alternately arranged. The stress tube 6 is provided with good support and strength as a whole by alternately arranging the continuous concave parts 61 and the intermittent concave parts 62, so that the stress of the stress tube 6 is more uniform, the stress tube 6 is prevented from cracking, and the fatigue performance of the stress tube 6 is improved. At the same time, the stress tube 6 can have good flexibility so as to adapt to the deformation generated by the catheter 2. The support and flexibility of the stress tube 6 can be balanced, the stress tube 6 is not too hard or too soft, the softness and stress relieving effect of the stress tube 6 are ensured, and the situation that the sleeve is damaged due to too thin wall of the stress tube 6 is avoided. Further, in the embodiment of the invention, each intermittent recess 62 includes two circumferential recess sections 621, the two circumferential recess sections 621 are symmetrically disposed, and the circumferential recess sections 621 between two adjacent intermittent recesses 62 are staggered.

With continued reference to fig. 3, the width d1 of each annular recess 611 is identical to the width d2 of each circumferential recess 621, so that the overall dimension of the stress tube 6 is more uniform, the stress of the stress tube 6 is more uniform, the bending of the stress tube 6 is smoother, and the stress concentration of the stress tube 6 at a certain point during bending is avoided. Meanwhile, in order to further ensure the flexibility and the smoothness of bending of the stress tube 6, the ratio of the axial length of the stress tube 6 to the width d1 or d2 is in the range of 24:1-28:1, and in the embodiment of the present invention, the ratio of the axial length of the stress tube 6 to the width d1 or d2 is specifically 26:1.

Referring to fig. 4, the balloon 1 includes a first layer 11 and a second layer 12, the second layer 12 is disposed near the inner tube 21, and the first layer 11 is disposed on a surface of the second layer 12 away from the inner tube 21. In order to ensure that the balloon 1 can reach the standard of high burst pressure, the material of the first layer 11 is nylon 12, the material of the second layer 12 is pebax, and the mass ratio of the first layer 11 to the second layer 12 is 6/4-8/2. In a specific embodiment of the present invention, the mass ratio of the first layer 11 to the second layer 12 is specifically 7/3. The dual-layer arrangement of the balloon 1 and the mass ratio of the first layer 11 to the second layer 12 are set to 7/3, so that the balloon 1 can have higher burst pressure, and the safety of the balloon 1 is further ensured. Meanwhile, the retraction performance of the balloon 1 can be ensured, so that the balloon 1 has lower blocking feeling in the process of retracting outside the body, and the retraction is smoother.

In other specific embodiments of the present invention, the balloon 1 may have a single-layer structure, and the balloon 1 is formed by extrusion molding after mixing nylon 12 and pebax according to a mass ratio of 7/3. The mass ratio of nylon 12 to pebax can be adaptively set according to the requirements of actual burst pressure and retractive performance, for example, the mass ratio of nylon 12 to pebax can be specifically 8/2 or 6/4, etc.

Referring to fig. 2 and 5, when the balloon 1 is not inflated, the balloon 1 includes a first straight line segment 13, a first transition segment 14, a second straight line segment 15, a second transition segment 16, and an inflation body 17, wherein the first straight line segment 13 is fixed on the outer surface of the end tube 3 and/or the inner tube 21, the first straight line segment 13 acts as a connection portion and is connected to the outer surface of the end tube 3 and/or the inner tube 21, in the embodiment of the present invention, a part of the first straight line segment 13 is connected to the outer surface of the end tube 3, and the rest of the first straight line segment 13 is connected to the outer surface of the inner tube 21. The proximal end of the first straight section 13 is connected to the distal end of the first transition section 14, and the proximal end of the first transition section 14 is connected to the distal end of the expansion body 17. The second straight section 15 is fixed on the outer surface of the outer tube 22, and the second straight section 15 acts as a connection point to connect with the outer surface of the outer tube 22. The distal end of the second straight section 15 is connected to the proximal end of the second transition section 16, and the distal end of the second transition section 16 is connected to the proximal end of the expansion body 17. The diameter of the first transition section 14 increases gradually from the distal end to the proximal end, and the diameter of the second transition section 16 increases gradually from the proximal end to the distal end.

It will be appreciated that in the embodiment of the present invention, the first straight line segment 13, the first transition segment 14, the second straight line segment 15, the second transition segment 16, and the expansion body 17 are integrally formed. The length of the inflatable body 17 is the effective length of the balloon 1, i.e. when the balloon 1 is inflated, the inflatable body 17 is the main portion of inflation, the remainder will not be inflated or only a small portion will be inflated, the length of the inflatable body 17 is 20mm-120mm. The inflated main body 17 is a portion having a diameter 5 to 7 times that of the balloon catheter 100 when the balloon catheter is not inflated in a natural state, for example, when the balloon catheter 100 is fitted with a 7F delivery sheath, the diameter of the balloon 1 when the balloon is not inflated is 2.31mm, and the diameter of the balloon 1 when inflated is 12mm. The number of the developing rings 4 is two, one developing ring 4 is disposed at a position where the inner tube 21 is connected to the expansion body 17 corresponding to the first transition section 14, and the other developing ring 4 is disposed at a position where the inner tube 21 is connected to the expansion body 17 corresponding to the second transition section 16. The developing ring 4 may be used to determine the position of the balloon 1 in the body, and the developing ring 4 may determine the position of the inflated body 17, so as to confirm the position of the effective length of the balloon 1 in the body, so that the effective length of the balloon 1 acts on the lesion more accurately. In other embodiments of the present invention, the first straight line segment 13, the first transition segment 14, the second straight line segment 15, the second transition segment 16, and the expansion body 17 may also be made separately.

Further, in the embodiment of the present invention, since the first and second straight line segments 13 and 15 have larger dimensions than the end tube 3, the inner tube 21 and the outer tube 22, if the first straight line segment 13 is directly connected to the end tube 3 and the inner tube 21, or the second straight line segment 15 is directly connected to the outer tube 22, the redundant portions of the first and second straight line segments 13 and 15 cannot be directly connected to the end tube 3, the inner tube 21 and the outer tube 22, and the redundant portions of the first and second straight line segments 13 and 15 will be stacked on the end tube 3, the inner tube 21 and the outer tube 22 and then thermally welded together, so that the outer diameters of the two end portions of the balloon 1 are increased. The minimum size of the balloon 1 after the flap is compressed depends on the size of the two end parts of the balloon 1, and if the size of the two end parts of the balloon 1 is larger, the size of the balloon 1 after the flap is compressed is also larger. Therefore, in order to reduce the size of the two end portions of the balloon 1, the compressed size of the flap of the balloon 1 is reduced, so as to reduce the damage to blood vessels and the damage to human bodies, the first straight line segment 13 and the second straight line segment 15 are directly connected with the tail end tube 3 and the inner tube 21 after being cut, and the redundant parts which cannot be directly connected with the tail end tube 3, the inner tube 21 and the outer tube 22 are avoided in the first straight line segment 13 and the second straight line segment 15, so that the compressed size of the flap of the balloon 1 is minimized.

Specifically, the distal end of the first straight line segment 13 and the proximal end of the second straight line segment 15 are uniformly cut, so that the distal end of the first straight line segment 13 includes at least two first matching portions 131 arranged at intervals, the proximal end of the second straight line segment 15 includes at least two second matching portions 151 arranged at intervals, the dimensions of each first matching portion 131 are the same, and the dimensions of each second matching portion 151 are the same. It will be appreciated that in the specific embodiment of the present invention, the first straight line segment 13 and the second straight line segment 15 are cut in the horizontal and vertical directions, and four first matching portions 131 and four second matching portions 151 are obtained after cutting. The four first matching parts 131 are connected with the tail end pipe 3 and the inner pipe 21, the four second matching parts 151 are connected with the outer pipe 22, the contact area between the first straight line section 13 and the second straight line section 15 and the tail end pipe 3, the inner pipe 21 and the outer pipe 22 is reduced, the first matching parts 131 can be all connected with the tail end pipe 3 and the inner pipe 21, the second matching parts 151 can be all connected with the outer pipe 22, and redundant parts of the first straight line section 13 and the second straight line section 15 are avoided. Meanwhile, the distal end of the first straight line segment 13 and the proximal end of the second straight line segment 15 are cut uniformly, so that the same size of each first matching portion 131 and the same size of each second matching portion 151 can be ensured, and further redundant portions caused by larger single sizes of a certain first matching portion 131 or a certain second matching portion 151 can be avoided.

Referring to fig. 2, the inner surface of the outer tube 22 and the outer surface of the inner tube 21 together define an annular cavity 211, and the inner cavity 18 of the balloon 1 communicates with the annular cavity 211. The proximal end of the catheter seat 5 is provided with a guide wire port 51 and a filling port 52, the guide wire port 51 is communicated with the cavity of the inner tube 21, and the filling port 52 is communicated with the annular cavity 211. Specifically, the guide wire port 51 is used for threading a guide wire, the guide wire is threaded from the guide wire port 51, then enters the cavity of the inner tube 21, passes through the inner tube 21, then enters the cavity of the end tube 3, and finally is threaded from the distal end of the end tube 3. The filling port 52 is used for supplying filling liquid into the annular cavity 211, and the filling liquid passes through the annular cavity 211 and then enters the inner cavity 18 of the balloon 1, so that the balloon 1 is inflated and expanded.

Further, referring to fig. 1, 2, 6 and 7, the distal end of the catheter seat 5 protrudes distally to form a step structure 53, an engaging portion 531 protrudes from the outer surface of the step structure 53, and the proximal end of the stress tube 6 is sleeved on the step structure 53 and is fixed on the step structure 53 by the engaging portion 531. The catheter seat 5 is provided with a first dispensing hole 54 and a second dispensing hole 55, the first dispensing hole 54 is disposed on the step structure 53, a ratio of a distance S1 between the first dispensing hole 54 and a distal end face of the step structure 53 to a length of the step structure 53 in an axial direction is 2/5-3/5, and the first dispensing hole 54 penetrates through to an outer surface of the outer tube 22. The second dispensing hole 55 is disposed on the catheter seat 5, a ratio of a distance S2 between the second dispensing hole 55 and a distal end face of the step structure 53 to a length of the catheter seat in an axial direction is 2/5-3/5, and the second dispensing hole 55 penetrates through to an outer surface of the inner tube 21.

It will be appreciated that glue may be dispensed into the first dispensing aperture 54 to thereby fix the outer tube 22 relative to the catheter hub 5. Glue is dropped into the second dispensing hole 55, so as to fix the inner tube 21 relative to the catheter seat 5. Meanwhile, the position of the first glue dispensing hole 54 is set at a distance S1 away from the distal end face of the step structure 53, so that the first glue dispensing hole 54 is at a certain distance from the distal end of the step structure 53, and at the same time, the first glue dispensing hole is at a certain distance from the proximal end of the outer tube 22 and the filling opening 52, so that glue can be prevented from penetrating into the annular cavity 211 and sealing the annular cavity 211, glue can be prevented from penetrating into the filling opening 52, sealing the filling opening 52 by the glue can be prevented, and overflow of the glue from the distal end of the catheter seat 5 can be prevented. The second dispensing hole 55 is disposed at a distance S2 away from the distal end face of the step structure 53, and the second dispensing hole 55 is disposed between one end D1 of the filling opening 52, which is close to the catheter 2, and one end D2 of the guide wire opening 51, which is close to the catheter 2, so that the second dispensing hole 55 is a certain distance from the proximal end of the outer tube 22, and is a certain distance from the guide wire opening 51 and the filling opening 52, thereby preventing glue from penetrating into the guide wire opening 51, the filling opening 52, and the annular cavity 211, and further preventing glue from blocking the guide wire opening 51, the filling opening 52, or the annular cavity 211.

With continued reference to fig. 1,2 and 7, the balloon 1 provided by the present invention has the characteristic of quick pressure relief, specifically, the ratio of the gap between the inner tube 21 and the outer tube 22 to the opening dimension L1 of the end of the filling port 52 near the catheter 2 is 1:8.8-1:3.6, and the ratio of the opening dimension L1 of the end of the filling port 52 near the catheter 2 to the opening dimension L2 of the end of the filling port 52 far from the catheter is 1:2.5-1:1.81. In the specific embodiment of the present invention, the gap between the inner tube 21 and the outer tube 22 is set to 0.25mm-0.5mm, the opening dimension L1 of the end of the filling opening 52 near the catheter 2 is 1.8mm-2.2mm, and the opening dimension L2 of the end of the filling opening 52 far from the catheter is 4mm-4.5mm. By setting the above dimensions, the flow rate of the liquid filled in the balloon 1 is faster, and the pressure relief time of the balloon 1 is reduced. For example, when the effective length of the balloon 1 is 60mm, the diameter of the balloon 1 after inflation is 18mm, the gap between the inner tube 21 and the outer tube 22 is set at 0.42mm, the opening dimension L1 of the end of the inflation port 52 near the catheter 2 is 2.06mm, and the opening dimension L2 of the end of the inflation port 52 away from the catheter is 4.29mm, the pressure relief time of the balloon 1 is 20 seconds.

With continued reference to fig. 2, the hardness of the end tube 3 is smaller than that of the inner tube 21 and the outer tube 22, and the ratio of the hardness of the end tube to that of the inner tube or the outer tube is in the range of 1:1.1-1:1.6, specifically, the hardness of the end tube 3 is 50D-60D, and the hardness of the inner tube 21 and the outer tube 22 is 67D-77D. In the specific embodiment of the present invention, the hardness of the end tube 3 is 55D, and the hardness of the inner tube 21 and the outer tube 22 is 72D. This is because the hardness of the distal end of the balloon catheter 100 is reduced, so that the smoothness of the balloon catheter 100 when it enters the human body is improved, and the balloon catheter 100 is prevented from damaging human tissues, blood vessels, and the like when it enters the human body. The hardness of the outer tube 22 and the inner tube 21 is high because the filled liquid applies pressure to the inner tube 21 and the outer tube 22 when the balloon 1 is filled, and the hardness of the inner tube 21 and the outer tube 22 is high to prevent the inner tube 21 and the outer tube 22 from being deformed.

Compared with the prior art, the balloon catheter has the advantages that the balloon catheter can effectively treat diseases of peripheral vascular systems, including percutaneous transluminal angioplasty of iliac arteries and iliac femoral veins, obstructive lesions for autologous or artificial arteriovenous dialysis fistulae and the like. The balloon has the characteristics of high burst pressure, good retractive performance and the like, and the diameter of the balloon after the flap is compressed is smaller, so that the damage to blood vessels and the damage to human bodies can be reduced. The setting of the spot gluing hole position can also skillfully avoid the situation that the guide wire port, the filling port or the annular cavity is blocked.

The above description is only of the preferred embodiments of the present invention and is not intended to limit the invention, but any modifications, equivalents, improvements, etc. within the principles of the present invention should be included in the scope of the present invention.

Claims (10)

1. The balloon catheter is characterized by comprising a balloon, a catheter, a tail end pipe, a catheter seat and a stress pipe, wherein the catheter comprises an inner pipe and an outer pipe, the outer pipe is sleeved outside the inner pipe, the distal end of the inner pipe is connected with the proximal end of the tail end pipe, the distal end of the balloon is fixed on the outer surface of the tail end pipe and/or the outer surface of the inner pipe, the proximal end of the balloon is fixed on the outer surface of the distal end of the outer pipe, the stress pipe is arranged at the distal end of the catheter seat, the proximal end of the inner pipe penetrates through the stress pipe and the catheter seat and then is fixed inside the proximal end of the catheter seat, and the proximal end of the outer pipe penetrates through the stress pipe and the catheter seat and then is fixed inside the distal end of the catheter seat.

2. The balloon catheter of claim 1, wherein the outer diameter of the stress tube gradually decreases from the proximal end to the distal end, the outer surface of the stress tube being provided with a plurality of alternating continuous depressions comprising annular depressions circumferentially disposed about the stress tube, and intermittent depressions comprising at least one circumferential depression section circumferentially disposed about the stress tube.

3. The balloon catheter of claim 1, wherein the balloon comprises a first layer and a second layer, the second layer is arranged close to the inner tube, the first layer is arranged on one surface of the second layer far away from the inner tube, the first layer is made of nylon 12, the second layer is made of pebax, and the mass ratio of the first layer to the second layer is in the range of 6/4-8/2.

4. The balloon catheter of claim 1, wherein the balloon comprises a first straight line segment, a first transition segment, a second straight line segment, a second transition segment, and an inflation body portion, wherein the first straight line segment is secured to the outer surface of the tip tube and/or the inner tube, the proximal end of the first straight line segment is connected to the distal end of the first transition segment, the proximal end of the first transition segment is connected to the distal end of the inflation body portion, the second straight line segment is secured to the outer surface of the outer tube, the distal end of the second straight line segment is connected to the proximal end of the second transition segment, and the distal end of the second transition segment is connected to the proximal end of the inflation body portion.

5. The balloon catheter of claim 4, wherein the diameter of the first transition section increases gradually from the distal end to the proximal end, the diameter of the second transition section increases gradually from the proximal end to the distal end, and the balloon catheter further comprises two development rings, one of the development rings being disposed at a position of the inner tube corresponding to the connection of the first transition section to the inflatable body portion, and the other development ring being disposed at a position of the inner tube corresponding to the connection of the second transition section to the inflatable body portion.

6. The balloon catheter of claim 1, wherein the inner surface of the outer tube and the outer surface of the inner tube together define an annular lumen, the lumen of the balloon being in communication with the annular lumen, the catheter hub proximal end being provided with a guidewire port in communication with the lumen of the inner tube and a filling port in communication with the annular lumen.

7. The balloon catheter of claim 6, wherein a ratio of a gap between the inner tube and the outer tube to an opening size of the filling port near an end of the catheter is 1:8.8-1:3.6, and a ratio of an opening size of the filling port near an end of the catheter to an opening size of the filling port far from the end of the catheter is 1:2.5-1:1.81.

8. The balloon catheter of claim 7, wherein the distal end of the catheter hub protrudes distally to form a stepped structure, a first dispensing hole and a second dispensing hole are formed in the catheter hub, the first dispensing hole is formed in the stepped structure, the first dispensing hole penetrates through the outer surface of the outer tube, the second dispensing hole is formed in the catheter hub, the second dispensing hole penetrates through the outer surface of the inner tube, and the second dispensing hole is located between one end of the filling port, which is close to the catheter, and one end of the wire guide port, which is close to the catheter.

9. The balloon catheter of claim 8, wherein the ratio of the distance of the first dispensing hole from the distal end surface of the step structure to the length of the step structure in the axial direction is 2/5-3/5, and the ratio of the distance of the second dispensing hole from the distal end surface of the step structure to the length of the catheter hub in the axial direction is 2/5-3/5.

10. The balloon catheter of claim 1, wherein the tip tube has a hardness less than the inner tube and the outer tube, and wherein the ratio of the hardness of the tip tube to the hardness of the inner tube or the outer tube is in the range of 1:1.1 to 1:1.6.