Balloon dilatation catheter

Abstract

The application discloses a balloon dilatation catheter, and relates to the technical field of medical devices, which comprises a catheter assembly and a dilatation element, and further comprises at least two linear elements and at least two lifting members, wherein the lifting members are arranged on the outer surface of the dilatation element and are interposed between the linear elements, the lifting members and the linear elements are arranged alternately, and each of the two sides of the linear element is connected with a lifting member. The balloon dilatation catheter can avoid the deviation of the linear element, prevent the collapse of the balloon shape, and improve the dilatation capacity of the balloon on calcified lesions.

Description

TECHNICAL FIELD

[0001] The present application relates to the technical field of medical devices, in particular to a balloon dilatation catheter. BACKGROUND

[0002] In the prior art, in order to dilate the calcified vascular stenosis, a plurality of linear elements with certain shapes are added to the outer surface of the balloon. During the balloon dilatation process, the linear elements are embedded into the calcified lesion to avoid the slip of the balloon relative to the lesion site, and at the same time, the linear elements perform force gathering and scoring on the calcified lesion, so that the calcified vascular stenosis is easy to dilate and obtain a good lumen.

[0003] However, in the actual balloon inflation and dilatation process, the linear elements on the outer surface of the balloon act on the calcified lesion like a jack, and the linear elements are in a state of being squeezed from both the balloon contact surface and the calcified lesion contact surface. At this time, if the calcified lesion contact surface is hard, the linear elements will have a tendency to move towards the center of the balloon. Because the contact between the outer surface of the balloon and the linear elements is local and the contact area is small, the force from the calcified lesion contact surface cannot be dispersed to all areas of the balloon surface, so the stress on the contact surface of the balloon with the linear elements is greater than that on the non-contact surface area, resulting in functional failure and collapse of the outer surface area of the balloon in contact with the linear elements. Thus, the linear elements are further functionally failed.

[0004] In addition, the linear elements are prone to shift compared to the circumferential position of the balloon, forming uneven distribution, affecting the texture effect of the balloon after dilating the calcified lesion, and also easily causing the linear elements to be too loose and get stuck when the balloon is withdrawn.

[0005] In the prior art CN108601929A, a balloon catheter and a manufacturing method of the balloon are disclosed. The linear elements are pressed on the outer surface of the balloon by a pressing member. Although the linear elements are placed between the balloon and the pressing member, the position shift of the linear elements can be inhibited and the occurrence of the sticking phenomenon can be reduced. However, the presence of the pressing member also introduces factors that affect the function of the linear elements in the direction of the calcified lesion contact surface-linear element-balloon contact surface, such as the pressing force opposite to the supporting force of the balloon surface and the material of the pressing member between the linear elements and the calcified lesion. The presence of these factors is mostly not conducive to the scoring and dilatation treatment of the calcified lesion by the entire balloon system. SUMMARY

[0006] The purpose of the present application is to provide a balloon dilatation catheter to solve the problems existing in the prior art, which can improve the linear element concentration scoring ability, and also avoid the problems of kinking, hanging and uneven distribution of the linear element, and further improve the processing ability of the balloon dilatation catheter to obtain the expected lumen of the calcified lesion.

[0007] To achieve the above purpose, the present application provides the following scheme:

[0008] The present application provides a balloon dilatation catheter, which comprises a catheter assembly, a dilatation element, at least two linear elements and at least two lifting members, the lifting members are arranged on the outer surface of the dilatation element and between the linear elements, the lifting members and the linear elements are arranged alternately, and the two sides of the linear element are connected with a lifting member.

[0009] Preferably, the extension direction of the linear element is consistent with the length direction of the catheter assembly, the linear element is a triangular cross-section spine, and the base of the spine is fixed on the outer wall of the dilatation element, and the top angle of the spine is used to contact the calcified lesion.

[0010] Preferably, the lifting member is an elastic film, the end of the elastic film is fixed on the waist of the spine, and is fixed near the bottom angle of the spine.

[0011] Preferably, the linear element is three, and the lifting member is three.

[0012] Preferably, the balloon dilatation catheter provided by the present application further comprises an elastic member, the elastic member is sleeved on the catheter assembly, one end of the elastic member is fixed on the outer wall of the catheter assembly, and the other end of the elastic member is connected with one end of the linear element.

[0013] Preferably, the elastic member is an elastic sleeve.

[0014] Preferably, the catheter assembly comprises a joint, a push rod and an inner tube, the inner tube is located in the push rod, and the two ends of the inner tube can communicate with the joint and the dilatation element, the joint is Y-shaped, one end of the joint is connected with one end of the push rod, the joint can be used for the passage of guide wire and inflation agent, and the other end of the push rod is connected with one end of the dilatation element and used for transmitting the inflation agent into the dilatation element.

[0015] Preferably, two developing rings are further fixed on the inner tube, the developing rings are located inside the dilatation element, and are arranged near the two ends of the dilatation element respectively.

[0016] Preferably, the dilatation element is a balloon.

[0017] The present application has the following technical effects relative to the prior art:

[0018] The balloon expansion catheter provided by the present application is provided with an expansion element installed at one end of a catheter assembly, and the catheter assembly can pass a filling agent into the expansion element to inflate the expansion element; the lifting members are arranged on the outer surface of the expansion element and are interposed between the linear elements, and the linear elements can act on the calcified lesions when the expansion element is inflated and extruded by the lifting members; the elastic members are sleeved on the catheter assembly, one end of the elastic members is fixed to the outer wall of the catheter assembly, the other end of the elastic members is connected to one end of the linear elements, and the other end of the linear elements is fixed to the catheter assembly; thus, when the expansion element is inflated, the position of the linear elements is compensated by the elongation of the elastic members, and when the expansion element is depressurized, the linear elements are reset by the pulling force of the retraction of the elastic members, so as to reduce the gap between the linear elements and the expansion element and inhibit the linear elements from being caught; the lifting members and the linear elements are arranged alternately, and the linear elements are connected to the lifting members on both sides of the linear elements; the linear elements are limited by the lifting members on both sides of the linear elements, and when the linear elements have a tendency to move towards the inside of the expansion element, the lifting members on both sides of the linear elements can pull up and constrain the linear elements on both sides, so as to avoid the left and right deviation of the linear elements relative to the calcified lesions and the deviation of the linear elements towards the inside of the expansion element to cause the collapse of the shape of the expansion element, increase the acting force of the linear elements and the expansion element on the calcified lesions, and effectively improve the expansion capacity of the expansion element on the calcified lesions. BRIEF DESCRIPTION OF DRAWINGS

[0019] In order to more clearly illustrate the technical solutions in the embodiments of the present application or the prior art, the following will briefly introduce the drawings needed in the embodiments. Obviously, the drawings described below only show some embodiments of the present application, and other drawings can be obtained by those skilled in the art without creative effort on the basis of these drawings.

[0020] Figure 1 is a structural schematic diagram of the balloon expansion catheter provided by the present application;

[0021] Figure 2 is a sectional view of the expansion element in the present application;

[0022] Figure 3 is a force analysis diagram of the linear element in the present application;

[0023] Figure 4 is a state diagram of the balloon when the balloon is acted on by the plaque without the lifting members;

[0024] Figure 5 is a state diagram of the balloon expansion catheter provided by the present application when the balloon is acted on by the plaque;

[0025] In the figure: 100 - balloon dilatation catheter, 1 - joint, 2 - push rod, 3 - elastic member, 4 - inner tube, 5 - dilatation element, 6 - wire element, 7 - visualization ring, 8 - branch tube, 9 - main tube, 10 - lifting member. DETAILED DESCRIPTION

[0026] The technical solutions in the embodiments of the present application will be described clearly and completely below with reference to the drawings in the embodiments of the present application. Obviously, the described embodiments are only part of the embodiments of the present application, rather than all the embodiments. Based on the embodiments in the present application, all other embodiments obtained by those of ordinary skill in the art without creative work fall within the protection scope of the present application.

[0027] The purpose of the present application is to provide a balloon dilatation catheter to solve the technical problem that the existing balloon dilatation catheter has poor dilatation ability for calcified lesions.

[0028] In order to make the above-mentioned purposes, features and advantages of the present application more obvious and easy to understand, the present application will be further described in detail below with reference to the drawings and specific embodiments.

[0029] As Figures 1-5As shown, the present application provides a balloon dilatation catheter 100, comprising a catheter assembly, a dilatation element 5, at least two linear elements 6 and at least two lifting members 10; the dilatation element 5 is installed at one end of the catheter assembly, and the catheter assembly can pass inflation agent into the dilatation element 5 and make the dilatation element 5 swell; the lifting members 10 are arranged on the outer surface of the dilatation element 5 and between the linear elements 6, and the linear elements 6 are fixed around the circumference of the dilatation element 5, and then with the swelling of the dilatation element 5, the linear elements 6 can act on the calcified lesions to perform forceful scoring; the lifting members 10 between the two linear elements 6 are elastically stretched along the outer surface of the dilatation element 5 with the inflation swelling of the dilatation element 5 and the constraint of the linear elements 6, and through such a setting, the linear element 6 contact surface area of the dilatation element 5 is provided for stress absorption, and then the sheet area is distributed to other non-linear element 6 contact surface areas of the dilatation element 5; the dilatation element 5 and the lifting member 10 mutually support the linear element 6 to enhance the forceful scoring ability. The lifting member 10 and the linear element 6 are alternately arranged, and the two sides of the linear element 6 are connected with a lifting member 10 respectively, and the linear element 6 is limited on both sides by the lifting member 10, when the linear element 6 has a tendency to move to the inside of the dilatation element 5, the lifting members 10 on both sides can constrain the linear element 6 on both sides, which not only avoids the left and right deviation of the linear element 6 relative to the calcified lesions, but also avoids the deviation of the linear element 6 to the direction close to the inside of the dilatation element 5, so as to cause the collapse of the shape of the dilatation element 5, increase the force of the linear element 6 and the dilatation element 5 on the calcified lesions, effectively promote the crack effect of the linear element 6 on the annular calcified blood vessel wall, and then improve the dilatation ability of the dilatation element 5 on the calcified lesions.

[0030] In use, when the dilatation element 5 inflation swells to support the linear element 6 to press the calcified lesion blood vessel, the lifting member 10 plays a stress absorption and distribution role, provides extrusion force compensation and lateral lifting force for the linear element 6, prevents the linear element 6 from moving to the direction close to the center of the dilatation element 5, and reduces the increasing degree of stress in the contact area of the dilatation element 5 and the linear element 6; at the same time, the lifting member 10 limits the circumferential deviation of the linear element 6 relative to the dilatation element 5, so that the linear elements 6 are uniformly distributed in parallel or approximately parallel on the circumferential position of the dilatation element 5, and the dilatation element 5 and the lifting member 10 mutually support the linear element 6. Among them, the angle α formed by the lifting member 10 and the linear element 6 connected thereto is on the side of the non-dilatation element 5; when 0° < angle α < 90°, the lifting member 10 plays a role of lifting the linear element 6; when 90° < angle α < 180°, the lifting member 10 can play a role of limiting the axial deviation of the linear element 6.

[0031] Specifically, the extension direction of the linear element 6 is consistent with the length direction of the catheter assembly. The linear element 6 is a spinous process with a triangular cross-section. According to finite element analysis, the spinous process has the most obvious effect compared to other shapes (such as squares). The bottom edge of the spinous process is fixed on the outer wall of the expansion element 5, and the apex of the spinous process is used to contact the calcified lesion. The contact between the spinous process and the calcified lesion is a line contact, which can also suppress displacement to a certain extent.

[0032] The lifting component 10 is an elastic membrane that can bind the linear element 6 to the surface of the expansion element 5 before and after the expansion element 5 is filled, preventing the linear element 6 from twisting or getting stuck. The end of the elastic membrane is fixed to the waist of the spinous process and near the bottom corner of the spinous process. The elasticity of the elastic membrane is higher than that of the expansion element 5, and its length is not greater than the effective length of the expansion element 5. When the expansion element 5 expands, the force F exerted by the plaque (i.e., the calcified lesion) on the spinous process and the expansion element 5... a The force F acting on the spinous process is greater than that of the spinous process and the expansion element 5. b (The plaque is relatively hard, and when the dilator 5 expands, it will compress the spinous process, causing the spinous process to tend to move towards the interior of the dilator 5), resulting in the spinous process moving closer to the interior of the dilator 5. During this process, such as Figure 3 As shown, the elastic membranes on both sides of each spinous process exert forces F1 and F2 on the spinous process, respectively. Decomposing F1 and F2 yields forces f1″ and f2″ acting on the plaque, thus increasing the force exerted by the spinous process on the plaque and ensuring that the direction of the spinous process does not deviate. This "not deviating" includes the direction towards the interior of the expansion element 5 (i.e.,...). Figure 3 The vertical offset of the spinous process also includes the direction of the spinous process toward the elastic membranes on both sides (i.e., the vertical direction). Figure 3 The offset (left-right direction) is limited by an elastic membrane, which reduces safety hazards and is more effective than the existing method of limiting offset by increasing the internal pressure of the expansion element 5. Even better, in actual manufacturing, the width of the elastic membrane (in the direction of connection with the spike) is set less than the effective length of the expansion element 5, and it is fixed by welding. The material of the elastic membrane can be a low-modulus TPE elastic material (thermoplastic elastomer) with a hardness of 0-60A and an elongation at break >600%, or other elastic materials in the existing technology.

[0033] There are three linear elements 6 and three lifting members 10. However, in the balloon dilation catheter 100 provided by the present invention, the number of linear elements 6 and three lifting members 10 is not limited to three. Those skilled in the art can make adaptive changes to their number according to actual needs.

[0034] The balloon dilatation catheter 100 provided by the application further comprises an elastic member 3 sleeved on the catheter assembly, one end of the elastic member 3 is fixed to the outer wall of the catheter assembly, the other end of the elastic member 3 is connected to one end of the linear element 6, the other end of the linear element 6 is fixed to the catheter assembly, and then when the expansion element 5 is inflated, the position of the linear element 6 is compensated by the elongation of the elastic member 3, when the expansion element 5 is depressurized, the linear element 6 is reset by the pulling force of the retraction of the elastic member 3, the gap between the linear element 6 and the expansion element 5 is reduced, and the linear element 6 is inhibited from being hooked. The elastic member 3 is an elastic sleeve.

[0035] The catheter assembly comprises a connector 1, a push rod 2 and an inner tube 4, the inner tube 4 is located in the push rod 2, the inner tube 4 penetrates through the whole balloon dilatation catheter 100, and the two ends of the inner tube 4 can communicate the connector 1 and the expansion element 5, the connector 1 is Y-shaped, one end of the connector 1 is connected to one end of the push rod 2, and the connector 1 can be used for the passing of a guide wire and a filling agent, the guide wire is used for overall guiding to deliver the balloon dilatation catheter 100 to a lesion site, and the filling agent is used for filling the expansion element 5 and making the expansion element 5 inflated, the other end of the push rod 2 is connected to one end of the expansion element 5 and is used for transmitting the filling agent into the expansion element 5.

[0036] Two developing rings 7 are further fixed on the inner tube 4, the developing rings 7 are located inside the expansion element 5 and are arranged close to the two ends of the expansion element 5 respectively, and the specific role and principle of the developing rings 7 are consistent with the prior art, and will not be described in detail here.

[0037] The expansion element 5 is a balloon, which can be inflated or depressurized along with the input and output of the filling agent.

[0038] The connector 1 comprises a main pipe 9 and a branch pipe 8, and the main pipe 9 and the branch pipe 8 are respectively used for the passing of the guide wire and the filling agent, so as to guide and expand the inflation and depressurization of the expansion element 5.

[0039] In the specification, specific examples are applied to the principles and implementation modes of the application, and the above examples are only used to help understand the method of the application and its core idea; meanwhile, for those skilled in the art, according to the idea of the application, the specific implementation mode and application range will be changed. In summary, the content of the specification should not be understood as a limitation of the application.

Claims

1. A balloon dilatation catheter comprising a catheter assembly, a dilatation element, characterized in that: The device further comprises at least three linear elements and at least three lifting members, the lifting members are arranged on the outer surface of the expansion element and between the linear elements, and the lifting members and the linear elements are arranged alternately, and each side of the linear element is connected with a lifting member; The extending direction of the linear element is consistent with the length direction of the catheter assembly, the linear element is a triangular ratchet, and the base of the ratchet is fixed on the outer wall of the expansion element, and the top angle of the ratchet is used for contacting the calcified lesion; The lifting member is an elastic film, the end of the elastic film is fixed on the waist of the ratchet, and the end close to the base of the ratchet is fixed; The elasticity of the elastic film is higher than that of the expansion element, and the length of the elastic film is not greater than the effective length of the expansion element; When the linear element has a tendency to move to the inside of the expansion element, the lifting members on both sides of the linear element can constrain the two sides of the linear element, which can avoid the left and right deviation of the linear element relative to the calcified lesion, and also avoid the deviation of the linear element to the inside of the expansion element, which can cause the collapse of the shape of the expansion element; The expansion element is a balloon.

2. The balloon dilation catheter of claim 1, wherein: The linear element is three, and the lifting member is three.

3. The balloon dilation catheter of claim 1, wherein: The device further comprises an elastic member, the elastic member is sleeved on the catheter assembly, one end of the elastic member is fixed on the outer wall of the catheter assembly, and the other end of the elastic member is connected with one end of the linear element.

4. The balloon dilation catheter of claim 3, wherein: The elastic member is an elastic sleeve.

5. The balloon dilation catheter of claim 1, wherein: The catheter assembly comprises a joint, a push rod and an inner tube, the inner tube is located in the push rod, and the two ends of the inner tube can communicate with the joint and the expansion element, the joint is Y-shaped, one end of the joint is connected with one end of the push rod, the joint can be used for the passage of a guide wire and a filling agent, and the other end of the push rod is connected with one end of the expansion element and used for transmitting the filling agent into the expansion element.

6. The balloon dilation catheter of claim 5, wherein: Two developing rings are further fixed on the inner tube, the developing rings are located in the expansion element and arranged close to the two ends of the expansion element respectively.

Images