Catheter

Abstract

The embodiment of the utility model discloses a catheter. The catheter comprises a bag body; an inner tube including a guidewire channel and a filled lumen coupled to the balloon; the guide wire channel penetrates through the balloon body and comprises a guide wire inlet positioned on the near side of the catheter and a guide wire outlet positioned on the far side of the balloon body; the outer tube wraps the inner tube, a first infusion cavity extending in the axial direction of the inner tube is formed between the outer tube and the inner tube, and the first infusion cavity comprises a first fluid inlet located on the near side of the catheter and a first fluid release opening located on the near side of the balloon body.

Description

Technical Field

[0001] The present invention relates to a medical device, and more particularly to a balloon catheter for treating a blood vessel. Background Art

[0002] Balloon catheters can be used to treat vascular diseases such as vascular access failure. In the field, there are mainly two types of balloon catheters, one is a dilatation balloon catheter (e.g., angioplasty balloon catheter) used to treat the narrowed or stenotic part of the blood vessel and restore flow, and the other is an occlusion balloon catheter used to infuse fluid (e.g., drugs, contrast enhancement agents or flushing materials) into the blood vessel. For example, during the treatment process, the doctor needs to use the dilatation balloon catheter for one or more dilatations, or may need to use the occlusion balloon catheter to infuse therapeutic agents into the corresponding lesion location in the blood vessel. And before and after the dilation, the doctor needs to perform intravascular angiography through the occlusion balloon catheter to confirm the specific condition of the lesion location. If the dilation effect of the blood vessel is not good, the occlusion balloon catheter needs to be withdrawn and the dilatation balloon catheter needs to be re-inserted to dilate the blood vessel, which not only causes a long treatment process, but also causes greater damage to the patient's blood vessels, and the operation is complicated, which is a great test for the doctor's proficiency in operation.

[0003] Therefore, it is necessary to propose a composite catheter that can simultaneously meet the treatment needs of dilation, angiography, and treatment. Utility Model Content

[0004] An embodiment of the present specification provides a catheter, comprising: a balloon body; an inner tube, the inner tube comprising a guidewire channel and a filling lumen connected to the balloon body; the guidewire channel passes through the balloon body, comprising a guidewire inlet positioned on the proximal side of the catheter and a guidewire outlet positioned on the distal side of the balloon body; an outer tube, the outer tube covering the inner tube, a first infusion lumen extending axially along the inner tube is formed between the outer tube and the inner tube, the first infusion lumen comprising a first fluid inlet positioned on the proximal side of the catheter and a first fluid release port positioned on the proximal side of the balloon body.

[0005] In some embodiments, the filling lumen, the guidewire channel and the first infusion lumen are independently provided.

[0006] In some embodiments, an annular ridge is sleeved on the inner tube located proximal to the balloon, the annular ridge protrudes from the outer wall of the inner tube, the outer tube covers the annular ridge, and the first fluid release port is located proximal to the annular ridge.

[0007] In some embodiments, the annular ridge is connected to the inner tube near the inner surface of the inner tube, and the annular ridge is connected to the outer tube near the outer surface of the outer tube.

[0008] In some embodiments, the outer tube positioned distal to the annular ridge has a narrowing section, the distance between the inner wall of the narrowing section of the outer tube and the outer wall of the inner tube gradually decreases along the axial direction, and the difference between the cross-sectional area of ​​the distal end of the narrowing section and the cross-sectional area of ​​the inner tube is 0 or less than a preset threshold.

[0009] In some embodiments, the distance between the proximal end of the narrowed section of the outer tube and the annular ridge is in the range of 0.2 mm to 3 mm.

[0010] In some embodiments, the length of the narrowed section of the outer tube ranges from 0.5 mm to 3 mm.

[0011] In some embodiments, a protrusion height of the annular ridge relative to the outer wall of the inner tube is smaller than a distance between the inner wall of the outer tube and the outer wall of the inner tube.

[0012] In some embodiments, the annular ridges are made of metal for visualization under ultrasound.

[0013] In some embodiments, the annular ridge includes an ultrasound reflection enhancing structure on the outer surface proximate to the outer tube.

[0014] In some embodiments, the ultrasound reflection enhancing structure comprises a concave-convex structure.

[0015] In some embodiments, the outer tube is formed of a material having a lower tensile modulus and / or a higher elongation at yield point than the material formed of the inner tube.

[0016] In some embodiments, the tensile modulus of the material forming the outer tube ranges from 200MPa to 650MPa, and the elongation at yield point of the material forming the outer tube ranges from 15% to 25%; or the tensile modulus of the material forming the inner tube ranges from 400MPa to 1280MPa, and the elongation at yield point of the material forming the inner tube ranges from 3% to 15%.

[0017] In some embodiments, the cross-sectional shape of the first infusion cavity is annular, and the cross-sectional area of ​​the first infusion cavity is 0.2 mm 2 -1.8mm 2 within the range.

[0018] In some embodiments, the first infusion lumen includes two or more first fluid release ports.

[0019] In some embodiments, the total opening area of ​​the two or more first fluid release ports is greater than the cross-sectional area of ​​the first infusion lumen.

[0020] In some embodiments, the cross-section of the filling lumen surrounds or partially surrounds the cross-section of the guidewire channel.

[0021] In some embodiments, the cross-sectional shape of the inner tube is circular, and in the cross-sectional shape of the inner tube, the cross-sectional shape of the filling lumen and the cross-sectional shape of the guidewire channel are symmetrical relative to the same midline of the cross-sectional shape of the inner tube.

[0022] In some embodiments, the inner tube further comprises a second infusion lumen extending axially along the inner tube, the second infusion lumen and the guidewire channel passing through the balloon together, the second infusion lumen comprising a second fluid inlet positioned proximal to the catheter and a second fluid release port positioned distal to the balloon.

[0023] In some embodiments, the filling lumen, the guidewire channel, the first infusion lumen, and the second infusion lumen are independently provided.

[0024] In some embodiments, a cross-section of the second infusion lumen and a cross-section of the filling lumen together surround or partially surround a cross-section of the guidewire channel.

[0025] In some embodiments, the cross-sectional shape of the inner tube is circular. On the cross-sectional shape of the inner tube, the cross-sectional shape of the filling lumen and the cross-sectional shape of the second infusion lumen are symmetrically distributed along the midline of the cross-sectional shape of the inner tube, and the cross-sectional shape of the guidewire channel is symmetrical relative to the midline of the symmetrical distribution of the cross-sectional shape of the filling lumen and the cross-sectional shape of the second infusion lumen.

[0026] In some embodiments, the cross-sectional area of ​​the second infusion lumen is 0.1 mm 2 -0.8mm 2 . BRIEF DESCRIPTION OF THE DRAWINGS

[0027] This specification will be further described in the form of exemplary embodiments, which will be described in detail by the accompanying drawings. These embodiments are not restrictive, and in these embodiments, the same number represents the same structure, wherein:

[0028] Figure 1 is an exemplary structural diagram of a catheter according to some embodiments of the present specification;

[0029] Figure 2 yes Figure 1 An enlarged view of region A shown in;

[0030] Figure 3 is a schematic cross-sectional view of a tube body according to some embodiments of the present specification;

[0031] Figure 4 is a schematic cross-sectional view of an inner tube according to some embodiments of the present specification;

[0032] Figure 5 is a schematic cross-sectional view of an inner tube according to other embodiments of the present specification;

[0033] Figure 6 is a schematic cross-sectional view of an inner tube according to some other embodiments of the present specification;

[0034] Figure 7 is a schematic cross-sectional view of a tube body according to other embodiments of the present specification;

[0035] Figure 8 is a schematic cross-sectional view of an inner tube according to some further embodiments of the present specification;

[0036] Fig. 9 is a cross-sectional view of a proximal tube body of a balloon according to some embodiments of the present specification;

[0037] Fig.10 is a distribution diagram of fluid release ports on a tube body according to some embodiments of this specification;

[0038] Fig.11 It is a diagram of the opening structure of the fluid release port shown in some embodiments of this specification. DETAILED DESCRIPTION

[0039] In order to more clearly illustrate the technical solutions of the embodiments of this specification, the following is a brief introduction to the drawings required for the description of the embodiments. Obviously, the drawings described below are only some examples or embodiments of this specification. For ordinary technicians in this field, this specification can also be applied to other similar scenarios based on these drawings without creative work. Unless it is obvious from the language environment or otherwise explained, the same reference numerals in the figures represent the same structure or operation.

[0040] As shown in this specification and claims, unless the context clearly indicates an exception, the words "a", "an", "an" and / or "the" do not refer to the singular and may also include the plural. Generally speaking, the terms "comprise" and "include" only indicate the inclusion of the steps and elements that have been clearly identified, and these steps and elements do not constitute an exclusive list. The method or device may also include other steps or elements.

[0041] Figure 1 is an exemplary structural diagram of a catheter according to some embodiments of the present specification.

[0042] like Figure 1 As shown, the catheter 100 includes a tube body 110 and a capsule 120. The tube body 110 has a certain length along its axial direction. The tube body 110 includes a catheter proximal side 111 and a catheter distal side 112. The catheter proximal side 111 refers to the side of the catheter 100 that is close to the user (such as a doctor) when in use, and the catheter distal side 112 is the side of the catheter 100 that is away from the user when in use. The capsule 120 is connected to the tube body 110 and is positioned at the catheter distal side 112. It should be noted that Figure 1 The bending of the tube body 110 shown is to exaggerate and simulate the shape of the tube body 110 in a blood vessel. Since the tube body 110 is flexible, the tube body 110 can be naturally extended in a natural state, and the axial direction of the tube body 110 extends along its body.

[0043] The tubular body 110 is surrounded to form various lumens (e.g., a guidewire channel, a filling lumen, an infusion lumen, etc.). In some embodiments, the proximal side 111 of the catheter is provided with various inlets corresponding to the various lumens (e.g., a guidewire inlet, a fluid inlet, etc.). In some embodiments, the tubular body 110 is surrounded to form a filling lumen, and the proximal side 111 of the catheter is provided with a filling port 131 corresponding to the filling lumen, and the filling port 131 is connected to the filling lumen. In some embodiments, the tubular body 110 is surrounded to form a guidewire channel, and the proximal side 111 of the catheter is provided with a guidewire inlet 141 corresponding to the guidewire channel, and the guidewire inlet 141 is connected to the guidewire channel. In some embodiments, the tubular body 110 is surrounded to form an infusion lumen, and the proximal side 111 of the catheter is provided with a fluid inlet corresponding to the infusion lumen, and the fluid inlet is connected to the infusion lumen. In some embodiments, the tube body 110 is surrounded by two or more infusion lumens (e.g., a first infusion lumen and a second infusion lumen), and the proximal side 111 of the catheter is provided with two or more infusion lumen fluid inlets (e.g., a first fluid inlet 151 and a second fluid inlet 161) corresponding to the two or more infusion lumens.

[0044] In some embodiments, a guidewire channel, a filling lumen, and an infusion lumen may be formed simultaneously in the tubular body 110. In some embodiments, the guidewire channel, the filling lumen, and the infusion lumen in the tubular body 110 are independent of each other and are not interconnected. In some embodiments, the guidewire channel, the filling lumen, and the two or more infusion lumens in the tubular body 110 are independent of each other and are not interconnected. The distribution of the guidewire channel, the filling lumen, and the infusion lumen in the tubular body 110 can refer to Figure 3-Figure 8 and related content.

[0045] In some embodiments, the catheter 100 further includes a catheter seat 170, which is positioned at the proximal side 111 of the catheter. In some embodiments, the catheter seat 170 is arranged around the tube body 110, and the catheter seat 170 is provided with a filling port 131, a guide wire inlet 141, and a fluid inlet (e.g., a first fluid inlet 151 and a second fluid inlet 161) extending outward, so as to facilitate the filling port 131, the guide wire inlet 141, and the fluid inlet to be connected to an external device (e.g., a filling device, etc.). In some embodiments, the catheter seat 170 and various inlets can be made of hard materials to ensure the service life of the catheter 100 and various inlets. Various hard inlets are also convenient for plugging and pulling connections with external devices. In some embodiments, the catheter 100 may also not include the catheter seat 170, and various inlets such as the filling port 131, the guide wire inlet 141, and the fluid inlet can be directly extended outward from the tube body 110. In some embodiments, since the tube body 110 needs to enter a blood vessel, it is generally made of soft materials, and various inlets extending directly outward from the tube body 110 can be made of hard materials to facilitate the connection of various inlets with external devices.

[0046] like Figure 1The distribution of the filling port 131, the guidewire inlet 141, and the fluid inlet (the first fluid inlet 151 and the second fluid inlet 161) shown is for example only, and the positions of the filling port 131, the guidewire inlet 141, and the fluid inlet (the first fluid inlet 151 and the second fluid inlet 161) can be interchanged or randomly distributed. For example, the filling port 131, the guidewire inlet 141, and the fluid inlet are all arranged toward the same side. In some embodiments, since the guidewire 200 needs to pass through the guidewire channel through the dedicated guidewire inlet 141, in order to facilitate the passage of the guidewire 200, the guidewire channel and the guidewire inlet 141 are coaxially arranged. In the case where the guidewire channel is coaxially arranged with the tube body 110, the guidewire inlet 141 is coaxially arranged with the tube body 110 (such as Figure 1 As shown in FIG. 1 , the guide wire inlet 141 extends axially along the tube body 110 .

[0047] The balloon 120 is a member that can expand under a certain pressure. The balloon 120 is sealed and connected to the filling lumen in the tube body 110, and the balloon 120 is adjacent to the distal end 112 of the catheter. In some embodiments, the filling lumen extends between the filling port 131 and the interface between the balloon 120 and the tube body 110. Gas or liquid is injected into the filling lumen through the filling port 131, and the injected gas or liquid passes through the filling lumen to fill the balloon 120 or expand the balloon 120.

[0048] In some embodiments, the guidewire channel includes not only a guidewire inlet 141, but also a guidewire outlet 142, and the guidewire outlet 142 is connected to the guidewire channel. The guidewire channel penetrates the capsule 120, that is, the wall of the tubular body 110 surrounding the guidewire channel penetrates the capsule 120, so that the guidewire 200 can pass through the capsule 120. For ease of explanation, the side of the capsule 120 close to the doctor when the catheter 100 is used is defined as the proximal side 121 of the capsule, and the side of the capsule 120 away from the doctor when the catheter 100 is used is defined as the distal side 122 of the capsule. The guidewire channel penetrates the capsule 120 from the proximal side 121 of the capsule to the distal side 122 of the capsule. The guidewire outlet 142 is positioned at the distal side 122 of the capsule.

[0049] Figure 2 yes Figure 1 In some embodiments, the Figure 2As shown, the infusion lumen includes not only a fluid inlet, but also a fluid release port. The fluid release port is an opening arranged on the wall of the tube body 110 for the fluid in the infusion lumen to flow into the blood vessel, and the fluid release port is connected to the infusion lumen. The fluid release port can be positioned at the proximal side 121 of the sac body, or at the distal side 122 of the sac body. In some embodiments, when the tube body 110 includes two or more infusion lumens, the fluid release ports corresponding to the two or more infusion lumens are separately arranged at the proximal side 121 of the sac body and the distal side 122 of the sac body. In some embodiments, the fluid release ports corresponding to the two or more infusion lumens can be simultaneously arranged at the proximal side 121 of the sac body or the distal side 122 of the sac body. Taking the first fluid release port 152 and the second fluid release port 162 as an example, the first fluid release port 152 is positioned at the proximal side 121 of the sac body, and the first fluid release port 152 is arranged on the wall of the tube body 110 between the proximal side 111 of the catheter and the distal side 112 of the catheter. The second fluid release port 162 is positioned at the distal end 122 of the sac body, and the infusion lumen corresponding to the second fluid release port 162 and the guidewire channel penetrate the sac body 120 together, that is, the portion of the tube body 110 that penetrates the sac body 120 includes the infusion lumen and the guidewire channel. The second fluid release port 162 is disposed on the wall of the tube body 110 between the guidewire outlet 142 and the sac body 120. In some embodiments, in order to ensure the flow rate of the fluid in the infusion lumen, an infusion lumen may include two or more fluid release ports. The distribution of the two or more fluid release ports on the wall of the tube body 110 can refer to Fig.10 In some embodiments, the opening shape of the fluid release port may include a regular shape or an irregular shape such as a circle, a square, a triangle, an ellipse, etc. The exemplary opening shape of the fluid release port can be referred to Fig.11 and related content.

[0050] In some embodiments, Figure 2 As shown, a developing ring 180 is sleeved on the portion of the tube body 110 that passes through the balloon 120. The developing ring 180 can be displayed under ultrasound to indicate the position of the balloon 120 in the blood vessel, so as to assist the doctor in determining whether the balloon 120 has reached the lesion position of the blood vessel. In some embodiments, two or more developing rings 180 are sleeved on the portion of the tube body 110 that passes through the balloon 120, and highlight the position of the balloon 120 under ultrasound, which is consistent with the developing marks set at other positions of the catheter 100 (e.g. Fig. 9 In some embodiments, one of the two or more developing rings 180 is disposed near the distal side 122 of the capsule, and another of the two or more developing rings 180 is disposed near the proximal side 121 of the capsule, which can indicate the extended length of the capsule 120 under ultrasound, helping doctors to accurately determine whether the capsule 120 covers the entire lesion location.

[0051] Figure 3It is a schematic cross-sectional view of a tube body according to some embodiments of the present specification.

[0052] Figure 3 The cross section of the tubular body 110 shown is a cross section of the tubular body 110 somewhere between the first fluid release port 152 and the proximal side 111 of the catheter. Figure 3 As shown, the cross section of the tube body 110 includes the cross section of the outer tube 113 and the cross section of the inner tube 114. There is a cross section of the first infusion cavity 150 between the cross section of the outer tube 113 and the cross section of the inner tube 114. The cross section of the inner tube 114 includes the cross section of the filling lumen 130 and the cross section of the guidewire channel 140.

[0053] The outer tube 113 covers the inner tube 114. In some embodiments, the outer tube 113 and the inner tube 114 are coaxially arranged so that the outer tube 113 and the inner tube 114 extend along the same axial direction. In some embodiments, the outer tube 113 and the inner tube 114 are spaced apart from each other, and an infusion lumen extending along the axial direction of the tube body 110 (i.e., the axial direction of the inner tube 114 or the axial direction of the outer tube 113) can be formed between the outer tube 113 and the inner tube 114, which is defined as a first infusion lumen 150. For more information about the outer tube 113 covering the inner tube 114, please refer to Fig. 9 and related content.

[0054] The outer tube 113 is a tubular structure extending in the axial direction. In some embodiments, the cross-sectional shape of the outer wall of the outer tube 113 is circular, which is a shape that fits the blood vessel and facilitates the movement of the catheter 100. The outer wall of the outer tube 113 refers to the outer surface of the outer tube 113 facing outward, that is, facing the blood vessel when in use. In some embodiments, the cross-sectional shape of the inner wall of the outer tube 113 can be any shape including regular shapes or irregular shapes such as circles, squares, and polygons. The inner wall of the outer tube 113 refers to the inner surface of the outer tube 113 facing the inner tube 114. In some embodiments, in order to ensure that the wall of the outer tube 113 can be evenly stressed when the fluid passes through the first infusion cavity 150 and to avoid damage to a certain part of the outer tube 113, the cross-sectional shape of the inner wall of the outer tube 113 is circular.

[0055] The inner tube 114 is a tubular structure extending in the axial direction. In some embodiments, the cross-sectional shape of the outer wall of the inner tube 114 is any shape including regular shapes such as circular, square, polygonal or irregular shapes. The outer wall of the inner tube 114 refers to the outer surface of the inner tube 114 facing the outer tube 113. Similarly, in some embodiments, in order to ensure that the wall of the outer tube 113 can be evenly stressed when the fluid passes through the first infusion cavity 150 and to avoid damage to a certain part of the outer tube 113, the cross-sectional shape of the outer wall of the inner tube 114 is circular. For ease of description, the following content describes the cross-sectional shape of the inner wall of the outer tube 113 being circular and the cross-sectional shape of the outer wall of the inner tube 114 being circular as examples.

[0056] In some embodiments, the first infusion lumen 150 is used for fluid delivery and release, and the delivered fluid is usually a therapeutic solvent, and / or a contrast solvent, or a mixed solvent of the two. In some embodiments, the cross-sectional shape of the first infusion lumen 150 is annular. In some embodiments, the inner diameter of the outer tube 113 is greater than the outer diameter of the inner tube 114, so that the cross-sectional area of ​​the first infusion lumen 150 formed between the outer tube 113 and the inner tube 114 is within a range of 0.2 mm 2 -1.8mm 2 The inner diameter of the outer tube 113 is the diameter of the outer tube 113 wall near the inner tube 114, and the outer diameter of the inner tube 114 is the diameter of the inner tube 114 wall near the outer tube 113. The cross-sectional area of ​​the first infusion cavity 150 can be obtained by the difference between the inner area of ​​the outer tube 113 obtained by the inner diameter of the outer tube 113 and the outer area of ​​the inner tube 114 obtained by the outer diameter of the inner tube 114. Ensure that the cross-sectional area of ​​the first infusion cavity 150 is within 0.2mm 2 -1.8mm 2 In the range of , it can be ensured that the flow rate of the fluid in the first infusion cavity 150 can meet the needs of treatment or angiography. At the same time, the inner diameter of the outer tube 113 is larger than the outer diameter of the inner tube 114, so that there is a gap between the outer tube 113 and the inner tube 114, without direct contact, reducing the friction between the inner wall of the outer tube 113 and the outer wall of the inner tube 114, making the tube body 110 easier to bend as a whole, and more adaptable to the direction of the blood vessel, ensuring the bending ability of the catheter 100 in the blood vessel, thereby ensuring the passability of the catheter 100 in the blood vessel. In some embodiments, the cross-sectional area range of the first infusion cavity 150 is 0.25mm 2 -1.7mm 2 In some embodiments, in order to control the overall cross-sectional size of the catheter 100, ensure that the catheter 100 can pass through the blood vessel smoothly, and on this basis, ensure that the wall thickness of the outer tube 113 is not too small and is damaged during use, the cross-sectional area range of the first infusion cavity 150 is 0.3mm 2 -1.5mm 2 .

[0057] The inner tube 114 is provided with a filling lumen 130 and a guidewire channel 140. In some embodiments, the filling lumen 130 extends axially along the tube body 110. In some embodiments, the cross-sectional shape of the filling lumen 130 can be any shape including regular shapes or irregular shapes such as crescent, circle, square, polygon, etc. In some embodiments, the guidewire channel 140 extends axially along the tube body 110. In some embodiments, the cross-sectional shape of the guidewire channel 140 can be any shape including regular shapes or irregular shapes such as circle, square, polygon, etc., but the cross-sectional size and shape design of the guidewire channel 140 need to enable the guidewire 200 to move freely in the guidewire channel 140. In some embodiments, the cross-sectional size of the guidewire channel 140 should not be excessively larger than the cross-sectional size of the guidewire 200 to avoid bending or accumulation of the guidewire 200 during the movement of the guidewire channel 140, which affects the movement of the guidewire 200. In some embodiments, as Figure 3 As shown, the cross-sectional shape of the guidewire 200 is circular, and the cross-sectional shape of the guidewire channel 140 is configured as a circle that surrounds the cross-sectional shape of the guidewire 200 and has the same or slightly larger size than the cross-sectional shape of the guidewire 200 (as shown in FIG. Figure 3 The difference in cross-sectional shape between the guidewire channel 140 and the guidewire 200 is shown in FIG.

[0058] Figure 4 It is a schematic cross-sectional view of an inner tube according to some embodiments of the present specification. Figure 5 It is a schematic cross-sectional view of an inner tube according to other embodiments of the present specification. Figure 6 It is a schematic cross-sectional view of an inner tube according to some other embodiments of the present specification.

[0059] In some embodiments, Figure 4 As shown, the cross-sectional shape of the guidewire channel 140 is an octagon, and the cross-sectional shape of the guidewire channel 140 is configured to surround the cross-sectional shape of the guidewire 200, and the octagon formed by the cross-sectional shape of the guidewire channel 140 is close to or circumscribed with the circle formed by the cross-sectional shape of the guidewire 200. In some embodiments, as Figure 5 As shown, the cross-sectional shape of the guidewire channel 140 is elliptical, and the cross-sectional shape of the guidewire channel 140 is configured to surround the cross-sectional shape of the guidewire 200 , and the shortest dimension of the cross-sectional shape of the guidewire channel 140 (ie, the short diameter of the ellipse) is close to or equal to the diameter of the cross-sectional shape of the guidewire 200 .

[0060] The filling lumen 130 and the guidewire channel 140 are independent of each other on the inner tube 114. In order to ensure that the delivery of the fluid or gas in the filling lumen 130 is not affected by the existence or shape of the guidewire 200 in the guidewire channel 140, the distance between the section of the filling lumen 130 and the section of the guidewire channel 140 can be made close to each other on the cross section of the inner tube 114. In some embodiments, reference Figure 3As shown, the portion of the cross section of the filling lumen 130 close to the guidewire channel 140 is a curved segment 132, and the shortest distances from each point on the curved segment 132 to the cross section of the guidewire channel 140 are close to or equal. And by making the shortest distances from each point on the curved segment 132 to the cross section of the guidewire channel 140 larger, the delivery of the fluid or gas in the filling lumen 130 is not affected by the existence or shape of the guidewire 200 in the guidewire channel 140, and the delivery of the fluid or gas in the filling lumen 130 is not squeezed to the guidewire 200 in the guidewire channel 140, thereby affecting the movement of the guidewire 200. In some embodiments, in order to make the squeezing of the flow of the fluid in the filling lumen 130 more balanced at various locations on the inner tube 114, avoid affecting the flow of the first infusion lumen 150, or avoid damage to a certain location on the inner tube 114, the cross section of the filling lumen 130 and the cross section of the guidewire channel 140 are both relative to the same center line on the cross section of the inner tube 114 (such as Figure 3-Figure 6 In some embodiments, as shown in the middle line (2), Figure 3 As shown, in order to make the distance between the cross-section of the filling lumen 130 and the cross-section of the guidewire channel 140 on the cross-section of the inner tube 114 close everywhere, the cross-section of the filling lumen 130 surrounds the cross-section of the guidewire channel 140, and the cross-section shape of the filling lumen 130 is a crescent shape surrounding the guidewire channel 140, or a semi-circular shape, etc.

[0061] In some embodiments, in order to make the distance between the cross section of the inner tube 114 and the cross section of the filled lumen 130 and the cross section of the guidewire channel 140 close everywhere, reference Figure 4 As shown, the cross-section of the filling lumen 130 partially surrounds the cross-section of the guidewire channel 140, that is, the curved segment 132 on the cross-section of the filling lumen 130 close to the guidewire channel 140 surrounds the cross-section of the guidewire channel 140, so that the shortest distances from each point on the curved segment 132 to the cross-section of the guidewire channel 140 are close or equal everywhere. The remaining line segments on the cross-section of the filling lumen 130 can be any line shape, or can be arranged arbitrarily and connected with the curved segment 132. In some embodiments, in order to prevent the delivery of the fluid or gas in the filling lumen 130 from being squeezed into the first infusion lumen 150 and affecting the flow of the first infusion lumen 150, the distance between the cross-section of the filling lumen 130 and the outer wall of the inner tube 114 can be close everywhere on the cross-section of the inner tube 114. In some embodiments, refer to Figure 3 , Figure 5 and Figure 6As shown in FIG. 1 , the portion of the cross section of the filling lumen 130 close to the outer wall of the inner tube 114 is a curved segment 133, and the shortest distances from each point on the curved segment 133 to the outer wall of the inner tube 114 are close or equal. And the shortest distances from each point on the curved segment 132 to the outer wall of the inner tube 114 are made larger, so that the delivery of the fluid or gas in the filling lumen 130 and the flow of the fluid in the first infusion lumen 150 are not affected by each other. In some embodiments, the curved segment 132 and the curved segment 133 can be smoothly connected by a line segment, such as Figure 3 and Figure 5 As shown, the curve segment 132 and the curve segment 133 can also be connected by several line segments, such as Figure 6 shown.

[0062] Figure 7 It is a schematic cross-sectional view of a tube body according to other embodiments of the present specification.

[0063] The inner tube 114 may also be provided with a second infusion lumen 160. The second infusion lumen 160 is used for fluid delivery and release, and the delivered fluid is usually a therapeutic solvent, and / or a contrast solvent, or a mixed solvent of the two. The second infusion lumen 160 extends axially along the tube body 110. In some embodiments, the cross-sectional shape of the second infusion lumen 160 may be any shape including regular shapes such as circular, square, polygonal, or irregular shapes. In some embodiments, in order to ensure that the flow rate of the fluid in the second infusion lumen 160 can meet the needs of treatment or contrast, the cross-sectional area of ​​the second infusion lumen 160 is within 0.1mm 2 -0.8mm 2 In some embodiments, in order to increase the flow rate of the fluid in the second infusion cavity 160, the cross-sectional area of ​​the second infusion cavity 160 is within the range of 0.2 mm 2 -0.8mm 2 In some embodiments, in order to control the overall cross-sectional size of the catheter 100, ensure that the catheter 100 can pass through the blood vessel smoothly, and on this basis, ensure that the wall thickness of the inner tube 114 is not too small and is damaged during use, the cross-sectional area of ​​the second infusion cavity 160 is within a range of 0.2mm 2 -0.5mm 2 .

[0064] The filling lumen 130, the guidewire channel 140 and the second infusion lumen 160 are each independent on the inner tube 114. In order to ensure that the delivery of the fluid or gas in the filling lumen 130 and the delivery of the fluid in the second infusion lumen 160 are not affected by the existence or shape of the guidewire 200 in the guidewire channel 140, the distance between the cross section of the second infusion lumen 160 and the filling lumen 130 and the cross section of the guidewire channel 140 can be close to each other in the cross section of the inner tube 114. In some embodiments, Figure 3-Figure 6Similarly to the above-mentioned related contents, the shortest distance from the part of the cross section of the second infusion cavity 160 close to the guidewire channel 140 to the cross section of the guidewire channel 140 is close to or equal to the shortest distance from the part of the cross section of the filling lumen 130 close to the guidewire channel 140 to the cross section of the guidewire channel 140. Moreover, the above-mentioned shortest distance is large, so that the delivery of the fluid or gas in the filling lumen 130 and the delivery of the fluid in the second infusion cavity 160 are not affected by the existence or shape of the guidewire 200 in the guidewire channel 140, and the delivery of the fluid or gas in the filling lumen 130 and the delivery of the fluid in the second infusion cavity 160 will not be squeezed to the guidewire 200 in the guidewire channel 140, thereby affecting the travel of the guidewire 200. In some embodiments, in order to make the various places on the inner tube 114 more evenly squeezed by the flow of the fluid in the filling lumen 130, avoid affecting the flow of the first infusion lumen 150, or avoid damage to a certain place on the inner tube 114, the cross section of the filling lumen 130 and the cross section of the second infusion lumen 160 are along the midline of the cross section of the inner tube 114 ( Figure 7-Figure 8 The cross section of the guide wire channel 140 is symmetrically distributed with respect to the cross section of the filling lumen 130 and the cross section of the second infusion lumen 160. Figure 7-Figure 8 The center line (O) shown is symmetrical.

[0065] In some embodiments, Figure 7 As shown, in order to make the distance between the cross section of the second infusion cavity 160 and the cross section of the filling lumen 130 close to the cross section of the guide wire channel 140 on the cross section of the inner tube 114, the cross section of the second infusion cavity 160 and the cross section of the filling lumen 130 surround the cross section of the guide wire channel 140, and the cross section shape of the second infusion cavity 160 and the cross section shape of the filling lumen 130 are jointly formed into a crescent shape surrounding the guide wire channel 140, or a semi-circular shape, etc. In some embodiments, in order to avoid the second infusion cavity 160 and the filling lumen 130 from affecting each other, the second infusion cavity 160 and the filling lumen 130 are spaced apart. In essence, it can be understood that Figure 3 Or the filled lumen 130 cross section shown in 5 is evenly divided into two, Figure 7 The second infusion lumen 160 and the filling lumen 130 are shown. In some embodiments, in order to make the distance between the second infusion lumen 160 and the filling lumen 130 on the cross section of the inner tube 114 close to the cross section of the guidewire channel 140, the cross section of the second infusion lumen 160 and the filling lumen 130 partially surround the cross section of the guidewire channel 140. In some embodiments, the cross section of the second infusion lumen 160 and the filling lumen 130 on the cross section of the inner tube 114 can be Figure 4 and Figure 6 The filling lumen 130 is shown to be evenly divided into two sections.

[0066] Figure 8It is a schematic cross-sectional view of an inner tube according to some further embodiments of the present specification.

[0067] like Figure 8 As shown, on the cross section of the inner tube 114, the cross section of the guidewire channel 140, the cross section of the second infusion lumen 160 and the cross section of the filling lumen 130 are evenly distributed to ensure that the guidewire channel 140, the second infusion lumen 160 and the filling lumen 130 do not affect each other. At the same time, the cross section of the guidewire channel 140, the cross section of the second infusion lumen 160 and the filling lumen 130 are all at a certain distance from the inner tube 114, so as not to affect the flow of the fluid in the first infusion lumen 150. In some embodiments, the cross-sectional areas and cross-sectional shapes of the guidewire channel 140, the second infusion lumen 160 and the filling lumen 130 are close or identical, so that the distances between the guidewire channel 140, the second infusion lumen 160 and the filling lumen 130 are equal or close. In some embodiments, the guidewire channel 140 , the second infusion lumen 160 , and the filling lumen 130 have circular cross-sectional shapes, and the guidewire channel 140 , the second infusion lumen 160 , and the filling lumen 130 are distributed in a triangular shape on the cross-section of the inner tube 114 .

[0068] The outer diameter of the catheter 100 involved in the embodiment of this specification is consistent with the outer diameter of the existing balloon dilatation catheter, and can smoothly enter the blood vessel. By making the catheter 100 include a guidewire channel 140, a second infusion lumen 160, a first infusion lumen 150 and a filling lumen 130, the catheter 100 can be expanded, angiographic, and treated at the same time to meet the treatment needs of expansion, angiography, and treatment. The first infusion lumen 150 is arranged between the inner tube 114 and the outer tube 113, which is conducive to reducing the friction between the inner wall of the outer tube 113 and the outer wall of the inner tube 114, making the tube body 110 easier to bend as a whole, and more adaptable to the direction of the blood vessel, ensuring the bending ability of the catheter 100 in the blood vessel, thereby ensuring the passability of the catheter 100 in the blood vessel.

[0069] In some embodiments, when the catheter 100 bends along the blood vessel, the outer tube 113 will deform more than the inner tube 114, and the flexibility of the outer tube 113 needs to be greater than that of the inner tube 114 to ensure the overall bending ability of the catheter 100. In addition, the inner tube 114 needs to carry the guidewire channel 140, the second infusion lumen 160 and the filling lumen 130, and the material forming the inner tube 114 needs to meet the requirements of high pressure resistance and a certain supporting force.

[0070] The bending ability of the catheter 100 can be determined by in vitro testing. For example, the in vitro test generally includes the following steps: prepare catheter A and catheter B. Catheter A includes an outer tube A and an inner tube A. Among them, the tensile modulus of the material forming the outer tube A is 510MPa and the elongation at yield point is 18%. The tensile modulus of the material forming the inner tube A is 950MPa and the elongation at yield point is 12%. Catheter B includes an outer tube B and an inner tube B. The tensile modulus of the material forming the outer tube B is 1100MPa and the elongation at yield point is 11%. The tensile modulus of the material forming the inner tube B is 950MPa and the elongation at yield point is 12%. The other components, structures, dimensions and other parameters of catheter A and catheter B are the same.

[0071] Water at 37°C is passed through the vascular model, and a guidewire and a sheath are inserted into the vascular model. Catheter A and catheter B (hereinafter referred to as the catheter) are delivered along the guidewire and the sheath, respectively. The distal end of the catheter remains stationary after reaching the initial position, and then the proximal end of the catheter is clamped on the push force tester. After preparation, the catheter is pushed along the guidewire with a pushing distance of 200mm. During this process, the push force tester is run to observe the tracking performance and bending ability of the catheter along the guidewire. After the push is completed, the catheter is withdrawn to the initial position along the guidewire. During the entire push and withdrawal process, the push force and withdrawal force detected by the push force tester are recorded. The entire push and withdrawal process can be repeated multiple times to obtain more accurate test results. The test results are shown in Table 1:

[0072] Table 1

[0073]

[0074] Referring to Table 1, the pushing force of catheter A is smaller, and the pushing force of catheter B is larger, which means that catheter A has better bending ability, and there is no significant difference in the retraction force between the two. The tensile modulus and yield point elongation of the forming material of inner tube A and inner tube B are the same, the tensile modulus of the forming material of outer tube A is smaller than the tensile modulus of the forming material of outer tube B, and the yield point elongation of the forming material of outer tube A is greater than the yield point elongation of the forming material of outer tube B, which means that the flexibility of outer tube A is greater than that of outer tube B. It can be seen that the bending ability of the catheter is related to the flexibility of its outer tube (or the whole), and the greater the flexibility, the better the bending ability.

[0075] In some embodiments, the material forming the outer tube 113 has a lower tensile modulus and / or a higher yield point elongation than the material forming the inner tube 114. In some embodiments, in order to ensure the overall bending ability of the catheter 100, the tensile modulus of the material forming the outer tube 113 is in the range of 200MPa-400MPa. In some embodiments, in order to make the catheter 100 have better bending ability, the tensile modulus of the material forming the outer tube 113 is in the range of 200MPa-320MPa. In some embodiments, in order to ensure the compressive performance of the outer tube 113 and avoid the outer tube 113 from rupturing during use, the tensile modulus of the material forming the outer tube 113 is in the range of 280MPa-320MPa. In some embodiments, in order to ensure the overall bending ability of the catheter 100, the yield point elongation of the material forming the outer tube 113 is in the range of 15%-25%. In some embodiments, in order to make the catheter 100 have better bending ability, the yield point elongation of the material forming the outer tube 113 is in the range of 19%-25%. In some embodiments, in order to ensure the compression resistance of the outer tube 113 and prevent the outer tube 113 from rupturing during use, the yield point elongation of the material forming the outer tube 113 is in the range of 19%-21%. In some embodiments, in order to enable the inner tube 114 to cooperate with the outer tube 113 to bend, so as to ensure the overall bending ability of the catheter 100, the tensile modulus of the material forming the inner tube 114 is in the range of 400MPa-1280MPa. In some embodiments, in order to enable the inner tube 114 to better cooperate with the outer tube 113 to bend, the tensile modulus of the material forming the inner tube 114 is in the range of 400MPa-880MPa. In some embodiments, in order to ensure the compression resistance of the inner tube 114 and prevent the inner tube 114 from rupturing during use, the tensile modulus of the material forming the inner tube 114 is in the range of 720MPa-880MPa. In some embodiments, in order to ensure the overall bending ability of the catheter 100, the yield point elongation of the material forming the outer tube 113 is in the range of 15%-25%. In some embodiments, in order to enable the inner tube 114 to cooperate with the outer tube 113 to bend, so as to ensure the overall bending ability of the catheter 100, the yield point elongation of the material forming the inner tube 114 is in the range of 400MPa-1280MPa. In some embodiments, in order to enable the inner tube 114 to better cooperate with the outer tube 113 to bend, the tensile modulus of the material forming the inner tube 114 is in the range of 400MPa-880MPa. In some embodiments, in order to ensure the compressive resistance of the inner tube 114 and prevent the inner tube 114 from rupturing during use, the tensile modulus of the material forming the inner tube 114 is in the range of 720MPa-880MPa. In some embodiments, in order to enable the inner tube 114 to cooperate with the outer tube 113 to bend, so as to ensure the overall bending ability of the catheter 100, the tensile modulus of the material forming the inner tube 114 is in the range of 400MPa-1280MPa.In some embodiments, in order to enable the inner tube 114 to better cooperate with the outer tube 113 to bend, the tensile modulus of the material forming the inner tube 114 is in the range of 400MPa-880MPa. In some embodiments, in order to ensure the compressive performance of the inner tube 114 and prevent the inner tube 114 from rupturing during use, the tensile modulus of the material forming the inner tube 114 is in the range of 720MPa-880MPa. In some embodiments, in order to enable the inner tube 114 to cooperate with the outer tube 113 to bend to ensure the overall bending ability of the catheter 100, the yield point elongation of the material forming the inner tube 114 is in the range of 3%-15%. In some embodiments, in order to enable the inner tube 114 to better cooperate with the outer tube 113 to bend, the yield point elongation of the material forming the inner tube 114 is in the range of 8%-15%. In some embodiments, in order to ensure the compressive performance of the inner tube 114 and prevent the inner tube 114 from rupturing during use, the yield point elongation of the material forming the inner tube 114 is in the range of 8%-10%. It should be noted that the embodiments of the tensile modulus range and the yield point elongation range of the materials forming the outer tube 113 and the inner tube 114 may be applied simultaneously or selectively.

[0076] In some embodiments, a ridge is provided between the inner wall of the outer tube 113 and the outer wall of the inner tube 114, which can further reduce the friction between the inner wall of the outer tube 113 and the outer wall of the inner tube 114, thereby ensuring the bending ability of the catheter 100 in the blood vessel. Fig. 9 shown.

[0077] Fig. 9 It is a cross-sectional view of the proximal tube body of the balloon according to some embodiments of the present specification.

[0078] like Fig. 9 As shown, an annular ridge 190 is sleeved on the inner tube 114 positioned at the proximal side 121 of the sac body. The annular ridge 190 protrudes from the outer wall of the inner tube 114. The outer tube 113 covers the annular ridge 190. The annular ridge 190 can separate the outer tube 113 and the inner tube 114, so that when the catheter 100 bends with the blood vessel, a certain degree of freedom of displacement or deformation can be generated between the outer tube 113 and the inner tube 114, thereby ensuring the bending ability of the catheter 100.

[0079] In some embodiments, the protrusion height of the ridge 190 relative to the outer wall of the inner tube 114 is less than the distance between the inner wall of the outer tube 114 and the outer wall of the inner tube 114. This prevents the ridge 190 from lifting the outer tube 114, thereby increasing the radial dimension of the catheter 100 at the ridge 190 and affecting the insertion of the catheter 100 into the blood vessel.

[0080] In some embodiments, the inner surface of the annular ridge 190 near the inner tube 114 is connected to the inner tube 114, and the outer surface of the annular ridge 190 near the outer tube 113 is connected to the outer tube 113 to fix the annular ridge 190. Since the outer tube 113 and the inner tube 114 both have a certain elasticity, the outer tube 113 and the inner tube 114 are not directly attached under the connection of the annular ridge 190, and a certain degree of freedom of displacement or deformation can still be generated between the outer tube 113 and the inner tube 114 when the catheter 100 bends with the blood vessel. In some embodiments, the annular ridge 190 and the inner tube 114 and the outer tube 113 can be sealed by welding or other connection methods.

[0081] In some embodiments, the first fluid release port 152 is positioned proximal to the annular ridge 190 (the side of the annular ridge 190 close to the physician when the catheter 100 is in use), so that the fluid in the first infusion lumen 150 can be released from the first fluid release port 152 .

[0082] In some embodiments, the annular ridge 190 is a circular ring structure adapted to the shape of the outer wall of the inner tube 114. In some embodiments, the circumferential cross section of the annular ridge 190 is a regular shape, such as an ellipse, a rectangle, a circle, etc. In some embodiments, the sharp corners of the circumferential cross section of the annular ridge 190 are polished to avoid wearing the inner tube 114 or the outer tube 113. In some embodiments, in order to indicate the position of the first fluid release port 152 under ultrasound display, the annular ridge 190 can be a developing ring that can be displayed under ultrasound. In some embodiments, the forming material of the annular ridge 190 is a metal material that can be developed under ultrasound, such as platinum-iridium alloy or tantalum. In some embodiments, the outer surface of the annular ridge 190 near the outer tube 113 includes an enhanced ultrasonic reflection structure to ensure that the annular ridge 190 can be clearly developed under ultrasound. In some embodiments, the enhanced ultrasonic reflection structure includes a concave-convex structure. For example, holes are densely distributed on the outer surface of the annular ridge 190. For another example, an uneven pattern is provided on the outer surface of the annular ridge 190. For another example, the outer surface of the annular ridge 190 is polished to make the outer surface uneven. By providing a concave-convex structure on the outer surface of the annular ridge 190 close to the outer tube 113 and increasing the friction index of the outer surface, the reflection of the annular ridge 190 under ultrasound can be enhanced, thereby enhancing the display of the annular ridge 190 under ultrasound.

[0083] In some embodiments, the first fluid release port 152 is provided on the outer tube 113 and is positioned on the proximal side of the annular ridge 190 (the side of the annular ridge 190 close to the doctor when the catheter 100 is in use). The fluid in the first infusion cavity 150 can be released from the first fluid release port 152. In some embodiments, in order to keep the first fluid release port 152 unobstructed, the first fluid release port 152 needs to be arranged close to the annular ridge 190. In some embodiments, the distance between the first fluid release port 152 and the annular ridge 190 in the axial direction of the tube body 110 is in the range of 0.3 mm to 2.5 mm. In some embodiments, the distance between the first fluid release port 152 and the annular ridge 190 in the axial direction of the tube body 110 is in the range of 0.5 mm to 2 mm. In some embodiments, the distance between the first fluid release port 152 and the capsule 120 in the axial direction of the tube body 110 is in the range of 8 mm to 25 mm. In some embodiments, the distance between the first fluid release port 152 and the capsule 120 in the axial direction of the tube body 110 is in the range of 10 mm to 20 mm.

[0084] In some embodiments, the distal end of the outer tube 113, that is, the end of the outer tube 113 away from the doctor when the catheter 100 is in use, is located between the ridge 190 and the balloon 120. In other words, the distal end of the outer tube 113 is located proximal to the balloon 120 and distal to the ridge 190 (the side of the ridge 190 away from the doctor when the catheter 100 is in use). Fig. 9 The outer tube 113 positioned at the distal side of the annular ridge 190 has a narrowing section 1131, which is gradually narrowed relative to the inner tube 114. In some embodiments, the narrowing section 1131 gradually tapers along the axial direction of the tube body 110 toward the capsule 120, and the distance between the inner wall of the narrowing section 1131 and the outer wall of the inner tube 114 gradually decreases along the axial direction, so that the cross-sectional area of ​​the narrowing section 1131 gradually approaches the cross-sectional area of ​​the inner tube 114. In some embodiments, the difference between the cross-sectional area of ​​the distal end of the narrowing section 1131, that is, the distal end of the outer tube 113, and the cross-sectional area of ​​the inner tube 114 is 0 (i.e., equal) or less than a preset threshold value (e.g., 1 mm), and the cross-sectional shape of the end of the narrowing section 1131 is consistent with the cross-sectional shape of the inner tube 114, so that the outer tube 113 and the inner tube 114 can achieve a substantially sealed connection. Thus, even when the ridge 190 is not sealed with the outer tube 113 and the inner tube 114, the fluid in the first infusion cavity 150 can be mostly released from the first fluid release port 152. By providing the narrowing section 1131 on the outer tube 113 to achieve connection with the inner tube 114, relative displacement can be generated between the outer tube 113 and the inner tube 114 when the catheter 100 bends with the blood vessel, thereby improving the bending ability of the catheter 100. In some embodiments, the part of the tube body proximal to the ridge 190 on the outer tube 113 smoothly transitions with the narrowing section 1131, so that the connection between the outer tube 113 and the inner tube 114 can pass smoothly in the blood vessel.

[0085] In some embodiments, to ensure that the annular ridge 190 separates the outer tube 113 and the inner tube 114, the proximal end of the narrowing section 1131 of the outer tube 113, that is, the end of the narrowing section 1131 close to the annular ridge 190, is 0.2 mm to 3 mm away from the annular ridge 190. In some embodiments, the proximal end of the narrowing section 1131 of the outer tube 113 is 0.3 mm to 2.5 mm away from the annular ridge 190. In some embodiments, the proximal end of the narrowing section 1131 of the outer tube 113 is 0.5 mm to 2 mm away from the annular ridge 190.

[0086] In some embodiments, in order to ensure that the connection between the outer tube 113 and the inner tube 114 can pass smoothly through the blood vessel, the length of the narrowed section 1131 of the outer tube 113 is in the range of 0.5 mm to 3 mm. In some embodiments, the length of the narrowed section 1131 of the outer tube 113 is in the range of 0.8 mm to 2.5 mm. In some embodiments, the length of the narrowed section 1131 of the outer tube 113 is in the range of 1 mm to 2 mm.

[0087] Continue to refer to Fig. 9 , the inner tube 114 is connected to the sac 120. The filling lumen 130 on the inner tube 114 is in communication with the sac 120, so that the gas or liquid transported in the filling lumen 130 enters the sac 120. The portion of the inner tube 114 carrying the guidewire channel 140 and the second infusion lumen 160 passes through the sac 120. In some embodiments, the guidewire outlet 142 is located on the portion of the inner tube 114 that passes through the sac 120, and the guidewire transported by the guidewire channel 140 exits from the guidewire outlet 142. In some embodiments, the second fluid release port 162 is located on the portion of the inner tube 114 that passes through the sac 120, and the fluid transported in the second infusion lumen 160 is released from the second fluid release port 162 located at the distal end 122 of the sac. The fluid in the first infusion lumen 150 between the inner tube 114 and the outer tube 113 is released from the first fluid release port 152 provided on the outer tube 113.

[0088] In the application of the catheter 100, the catheter 100 needs to be used together with a sheath, a guide wire, a filler and other instruments commonly used in interventional surgery. First, perform surgical puncture, insert a guide wire, perform interventional opening of the blood vessel according to the location of the lesion in the blood vessel, establish a vascular access, and then connect the first fluid inlet of the first infusion cavity of the catheter 100 to a syringe filled with contrast agent (contrast agent) and exhaust the air, then insert the capsule along the guide wire, after the capsule passes over the narrow position of the lesion, perform angiography confirmation at the proximal side of the capsule through the infusion lumen, and then perform a pressurization operation on the capsule through the filling device to expand the capsule and perform expansion treatment on the lesion. During the treatment process, before and after the expansion of the capsule, the first infusion cavity and the second infusion cavity can be used to release contrast agents and / or therapeutic agents, or a mixed solvent of the two, to the proximal side of the capsule in the blood vessel and / or the distal side of the capsule, for angiography confirmation and / or drug treatment, without the need to withdraw the capsule and replace the angiography catheter. The annular ridge can indicate the position of the first fluid release port under ultrasound, so as to observe whether the first fluid release port reaches the lesion position. The developing ring in the capsule can indicate the covering position of the capsule under ultrasound, so as to observe whether the capsule covers the lesion and stenosis position of the blood vessel.

[0089] Fig.10 This is a distribution diagram of fluid release ports on a tube body according to some embodiments of this specification. Fig.11 It is a diagram of the opening structure of the fluid release port shown in some embodiments of this specification.

[0090] In some embodiments, Fig.10 As shown in a, the fluid release port is an opening provided on the tube body. The first fluid release port 152 is an opening provided on the outer tube 113 near the annular ridge 190. The second fluid release port 162 is an opening on a portion of the inner tube 114 at the distal side 122 of the balloon body.

[0091] In some embodiments, the opening shapes of the first fluid release port 152 and the second fluid release port 162 can be any shape, for example, Fig.11 The square circle shown in a, such as Fig.11 The oval shown in b, Fig.11 The circle shown in c, Fig.11 Regular or irregular shapes such as square, triangle, polygon, etc. as shown in (d).

[0092] In some embodiments, in order to prevent the first fluid release port 152 or the second fluid release port 162 from being blocked in the blood vessel, resulting in the inability to release the fluid, it is necessary to set a plurality of first fluid release ports 152 and / or a plurality of second fluid release ports 162 on the tube body 110 to reduce the probability of the first fluid release port 152 or the second fluid release port 162 being blocked. Specifically, two or more first fluid release ports 152 are set on the outer tube 113 near the annular ridge 190. Two or more second fluid release ports 162 are set on a portion of the inner tube 114 at the distal side 122 of the capsule.

[0093] Taking the first fluid release port 152 as an example, the second fluid release port 162 is similar thereto. Fig.10 As shown in FIG. 1 b, two or more first fluid release ports 152 may be distributed along the axial circumference of the outer tube 113. Fig.10 As shown in c, two or more first fluid release ports 152 may be distributed in an array on the outer tube 113 .

[0094] In some embodiments, the first fluid release port 152 has a certain opening area, and the sum of the opening areas of two or more first fluid release ports 152 is greater than the cross-sectional area of ​​the first infusion cavity 150, increasing the speed at which the fluid flows out of the first fluid release port 152, thereby ensuring the flow rate of the fluid in the first infusion cavity 150. In some embodiments, the second fluid release port 162 has a certain opening area, and the sum of the opening areas of two or more second fluid release ports 162 is greater than the cross-sectional area of ​​the second infusion cavity 160, increasing the speed at which the fluid flows out of the second fluid release port 162, thereby ensuring the flow rate of the fluid in the second infusion cavity 160.

[0095] The basic concepts have been described above. Obviously, for those skilled in the art, the above detailed disclosure is only for example and does not constitute a limitation of this specification. Although not explicitly stated here, those skilled in the art may make various modifications, improvements and corrections to this specification. Such modifications, improvements and corrections are suggested in this specification, so such modifications, improvements and corrections still belong to the spirit and scope of the exemplary embodiments of this specification.

[0096] At the same time, this specification uses specific words to describe the embodiments of this specification. For example, "one embodiment", "an embodiment", and / or "some embodiments" refer to a certain feature, structure or characteristic related to at least one embodiment of this specification. Therefore, it should be emphasized and noted that "one embodiment" or "an embodiment" or "an alternative embodiment" mentioned twice or more in different positions in this specification does not necessarily refer to the same embodiment. In addition, certain features, structures or characteristics in one or more embodiments of this specification can be appropriately combined.

[0097] In some embodiments, numbers describing the number of components and attributes are used. It should be understood that such numbers used in the description of the embodiments are modified by the modifiers "about", "approximately" or "substantially" in some examples. Unless otherwise specified, "about", "approximately" or "substantially" indicate that the numbers are allowed to vary by ±20%. Accordingly, in some embodiments, the numerical parameters used in the specification and claims are approximate values, which may change according to the required features of individual embodiments. In some embodiments, the numerical parameters should take into account the specified significant digits and adopt the general method of retaining digits. Although the numerical domains and parameters used to confirm the breadth of their range in some embodiments of this specification are approximate values, in specific embodiments, the setting of such numerical values ​​is as accurate as possible within the feasible range.

Claims

1. A catheter, characterized in that: include: cystic body; An inner tube, the inner tube comprising a guidewire channel and a filling lumen connected to the balloon; the guidewire channel runs through the balloon, comprising a guidewire inlet positioned proximal to the catheter and a guidewire outlet positioned distal to the balloon; An outer tube covers the inner tube, and a first infusion cavity extending axially along the inner tube is formed between the outer tube and the inner tube. The first infusion cavity includes a first fluid inlet positioned proximal to the catheter and a first fluid release port positioned proximal to the balloon.

2. The catheter according to claim 1, characterized in that The filling lumen, the guidewire channel and the first infusion lumen are independently arranged.

3. The catheter according to claim 1, characterized in that An annular ridge is sleeved on the inner tube located at the proximal side of the balloon, the annular ridge protrudes from the outer wall of the inner tube, the outer tube covers the annular ridge, and the first fluid release port is located at the proximal side of the annular ridge.

4. The catheter according to claim 3, characterized in that The outer tube positioned distally of the annular ridge has a narrowing section, the distance between the inner wall of the narrowing section of the outer tube and the outer wall of the inner tube gradually decreases along the axial direction, and the difference between the cross-sectional area of ​​the distal end of the narrowing section and the cross-sectional area of ​​the inner tube is 0 or less than a preset threshold.

5. The catheter according to claim 3, characterized in that The protruding height of the annular ridge relative to the outer wall of the inner tube is smaller than the distance between the inner wall of the outer tube and the outer wall of the inner tube.

6. The catheter according to claim 5, characterized in that The annular ridge is made of metal for visualization under ultrasound.

7. The catheter according to claim 6, characterized in that The annular ridge includes an ultrasound reflection enhancing structure on an outer surface close to the outer tube.

8. The catheter according to claim 7, characterized in that The ultrasonic reflection enhancement structure includes a concave-convex structure.

9. The catheter according to claim 1, characterized in that The outer tube may be formed of a material having a lower tensile modulus and / or a higher elongation at yield point than the material formed of the inner tube.

10. The catheter according to claim 1, characterized in that The tensile modulus of the material forming the outer tube is in the range of 200MPa-650MPa, and the yield point elongation of the material forming the outer tube is in the range of 15%-25%; or The tensile modulus of the material forming the inner tube is in the range of 400MPa-1280MPa, and the yield point elongation of the material forming the inner tube is in the range of 3%-15%.

11. The catheter according to claim 1, characterized in that The cross-sectional shape of the first infusion cavity is annular, and the cross-sectional area of ​​the first infusion cavity is 0.2 mm 2 -1.8mm 2 within the range.

12. The catheter according to claim 1, characterized in that The first infusion lumen includes two or more first fluid release ports.

13. The catheter according to claim 12, characterized in that The total opening area of ​​the two or more first fluid release ports is greater than the cross-sectional area of ​​the first infusion cavity.

14. The catheter according to claim 1, characterized in that The cross-section of the filling lumen surrounds or partially surrounds the cross-section of the guidewire channel.

15. The catheter according to claim 1, characterized in that The cross-sectional shape of the inner tube is circular. On the cross-sectional shape of the inner tube, the cross-sectional shape of the filled lumen and the cross-sectional shape of the guidewire channel are both symmetrical with respect to the same center line of the cross-sectional shape of the inner tube.

16. The catheter according to claim 1, characterized in that The inner tube also includes a second infusion lumen extending axially along the inner tube, the second infusion lumen and the guidewire channel passing through the balloon together, and the second infusion lumen includes a second fluid inlet positioned proximal to the catheter and a second fluid release port positioned distal to the balloon.

17. The catheter according to claim 16, characterized in that The filling lumen, the guidewire channel, the first infusion lumen and the second infusion lumen are independently arranged.

18. The catheter according to claim 16, characterized in that The cross section of the second infusion lumen and the cross section of the filling lumen jointly surround or partially surround the cross section of the guidewire channel.

19. The catheter according to claim 16, characterized in that The cross-sectional shape of the inner tube is circular. On the cross-sectional shape of the inner tube, the cross-sectional shape of the filling lumen and the cross-sectional shape of the second infusion lumen are symmetrically distributed along the midline of the cross-sectional shape of the inner tube, and the cross-sectional shape of the guidewire channel is symmetrical relative to the midline on which the cross-sectional shape of the filling lumen and the cross-sectional shape of the second infusion lumen are symmetrically distributed.

20. The catheter according to claim 16, characterized in that The cross-sectional area of ​​the second infusion cavity is 0.1 mm 2 -0.8mm 2 .

Images