Balloon catheter

Abstract

The present invention provides a balloon catheter, comprising: an outer tube, an inner tube, an end tube and a balloon; the inner tube passes through the inner cavity of the outer tube, and a first channel is formed between the inner wall of the outer tube and the outer wall of the inner tube; the end tube is connected to the distal end of the inner tube, the balloon is sleeved on the outside of the inner tube, the distal end of the balloon is connected to the distal end of the inner tube or the end tube, the proximal end of the balloon is connected to the outer tube, and the balloon is in fluid communication with the first channel; the inner tube is provided with a second channel extending axially, and the side wall of the inner tube is provided with at least one side opening, and the second channel is in fluid communication with the balloon via the side opening. The balloon catheter provided by the present invention forms a circulation channel through the second channel, the side opening, the inner cavity of the balloon and the first channel, which can realize real-time flow replacement of the liquid medium inside the balloon, thereby preventing bubbles from accumulating inside the balloon, and has a flushing effect on the inner cavity of the balloon, which can prevent bubbles and impurities from accumulating inside the balloon and affecting the function and effectiveness of the product.

Description

Technical Field

[0001] The present invention relates to the technical field of medical devices, and in particular to a balloon catheter. Background Art

[0002] Existing shock wave balloon catheters typically include a catheter and a balloon located at the distal end of the catheter, which can be filled and expanded with liquid. A shock wave generator is installed in the balloon, and the shock wave transmits the impact force through the liquid filled in the balloon and acts on the balloon wall and the calcified lesion area. The repeated shock waves can soften and break up the calcified area, thereby treating and alleviating the patient. During use, especially when shock waves are generated by electrode discharge, a large number of bubbles will be generated in the liquid medium in the balloon. As the shock wave continues to occur, the bubbles will produce a cavitation effect to load the shock wave, further enhancing the shock wave effect. The cavitation effect refers to the continuous movement and growth of small bubbles with the vibration of the surrounding medium until they burst. However, in actual practice, not all bubbles generated in the liquid medium can burst. As the number of shock wave emissions accumulates, a large number of unburst bubbles will accumulate inside the balloon. The residual bubbles will make the liquid medium in the balloon unbalanced and affect the transmission of the shock wave, thereby reducing the effectiveness of the surgical treatment. Summary of the Invention

[0003] The object of the present invention is to provide a balloon catheter to alleviate the technical problem of air bubbles accumulating inside the balloon and being unable to be discharged in existing balloon catheters.

[0004] In a first aspect, the present invention provides a balloon catheter comprising: an outer tube, an inner tube, a terminal tube, and a balloon;

[0005] The inner tube passes through the inner cavity of the outer tube, and a first channel is formed between the inner wall of the outer tube and the outer wall of the inner tube;

[0006] The terminal tube is connected to the distal end of the inner tube, the balloon is sheathed on the outside of the inner tube, the distal end of the balloon is connected to the distal end of the inner tube or the terminal tube, the proximal end of the balloon is connected to the outer tube, and the balloon is in fluid communication with the first channel;

[0007] The inner tube is provided with a second channel extending in the axial direction, and the side wall of the inner tube is provided with at least one side opening, and the second channel is communicated with the balloon through the side opening.

[0008] In combination with the first aspect, the present invention provides a first possible implementation manner of the first aspect, wherein the ratio of the length of the side opening to the diameter of the side opening is less than or equal to 0.5, or greater than 0.5 and less than or equal to 4.

[0009] In combination with the first aspect, the present invention provides a second possible implementation of the first aspect, wherein the side opening is located at the distal end of the balloon lumen.

[0010] In combination with the first aspect, the present invention provides a third possible implementation of the first aspect, wherein the diameter of the side opening gradually decreases from the inside to the outside along the wall thickness direction.

[0011] In combination with the first aspect, the present invention provides a fourth possible implementation of the first aspect, wherein the ratio of the area of ​​the second channel to the area of ​​the first channel in a cross section perpendicular to the axis of the outer tube is 1:4 to 1:1.

[0012] In combination with the first aspect, the present invention provides a fifth possible implementation of the first aspect, wherein a shock wave generator is installed on the inner tube, and the shock wave generator is located inside the balloon.

[0013] In combination with the first aspect, the present invention provides a sixth possible implementation of the first aspect, wherein the inner tube is provided with a first guidewire cavity, the terminal tube is provided with a second guidewire cavity connected to the first guidewire cavity, and the first guidewire cavity and the second guidewire cavity are connected to each other for inserting a guide wire.

[0014] In combination with the first aspect, the present invention provides a seventh possible implementation of the first aspect, wherein the balloon catheter further comprises a catheter seat connected to the proximal ends of the outer tube and the inner tube;

[0015] The catheter seat is provided with a liquid filling port and a liquid withdrawal port, the liquid filling port is in fluid communication with the second channel, and the liquid withdrawal port is in fluid communication with the first channel.

[0016] In combination with the seventh possible implementation manner of the first aspect, the present invention provides an eighth possible implementation manner of the first aspect, wherein the catheter seat is further provided with a guidewire port communicated with the inner tube.

[0017] In combination with the seventh possible implementation of the first aspect, the present invention provides a ninth possible implementation of the first aspect, wherein a first guidewire cavity is provided in the inner tube, and a second guidewire cavity communicating with the first guidewire cavity is provided on the catheter seat.

[0018] The embodiments of the present invention bring the following beneficial effects: an inner tube is passed through the inner cavity of an outer tube, and a first channel is formed between the inner wall of the outer tube and the outer wall of the inner tube, the terminal tube is connected to the distal end of the inner tube, the balloon is sleeved on the outside of the inner tube, the distal end of the balloon is connected to the distal end or the terminal tube of the inner tube, the proximal end of the balloon is connected to the outer tube, and the balloon is fluidically connected to the first channel, and a second channel is arranged along the axial direction of the inner tube, the second channel is connected to the balloon through the side opening of the side wall of the inner tube, the second channel, the side opening, the inner cavity of the balloon, and the first channel together can form a circulating flow channel, thereby realizing real-time flow replacement of the liquid medium inside the balloon, thereby avoiding the accumulation of bubbles inside the balloon, and having a flushing effect on the inner cavity of the balloon, thereby avoiding the accumulation of bubbles and impurities inside the balloon and affecting the function and effectiveness of the product.

[0019] In order to make the above-mentioned objects, features and advantages of the present invention more obvious and easy to understand, preferred embodiments are given below and described in detail with reference to the accompanying drawings. BRIEF DESCRIPTION OF THE DRAWINGS

[0020] In order to more clearly illustrate the specific embodiments of the present invention or the technical solutions in related technologies, the following briefly introduces the drawings required for use in the specific embodiments or related technical descriptions. Obviously, the drawings described below are some embodiments of the present invention. For ordinary technicians in this field, other drawings can be obtained based on these drawings without paying any creative work.

[0021] Figure 1 A schematic diagram of a balloon catheter provided in accordance with a first embodiment of the present invention;

[0022] Figure 2 for Figure 1 Cross-section view at position A-A;

[0023] Figure 3 A partially enlarged schematic diagram of the balloon catheter provided by the first embodiment of the present invention;

[0024] Figure 4 A partial cross-sectional view of the outer tube and inner tube of a balloon catheter provided by an embodiment of the present invention;

[0025] Figure 5 A schematic diagram of a catheter adapter provided in accordance with a first embodiment of the present invention;

[0026] Figure 6 It is a schematic diagram of the orifice flow-pressure characteristic curve;

[0027] Figure 7 A partially enlarged schematic diagram of a balloon catheter provided in a second embodiment of the present invention;

[0028] Figure 8 for Figure 7 Cross-section at the B-B position;

[0029] Figure 9 A schematic diagram of a catheter adapter provided according to a second embodiment of the present invention.

[0030] Icons: 100 - outer tube; 200 - inner tube; 201 - second channel; 202 - side opening; 203 - first guidewire lumen; 204 - first guidewire lumen; 300 - terminal tube; 400 - balloon; 500 - first channel; 600 - shock wave generator; 700 - catheter hub; 701 - filling port; 702 - withdrawal port; 703 - guidewire port; 704 - second guidewire lumen; 800 - guidewire; 900 - guidewire. DETAILED DESCRIPTION

[0031] The technical solution of the present invention will be clearly and completely described below with reference to the accompanying drawings. Obviously, the embodiments described are only some embodiments of the present invention, not all embodiments. All other embodiments obtained by ordinary technicians in this field based on the embodiments of the present invention without making any creative efforts shall fall within the scope of protection of the present invention.

[0032] In the description of the present invention, it should be noted that the terms "center", "up", "down", "left", "right", "vertical", "horizontal", "inside", "outside" and the like indicate orientations or positional relationships based on the orientations or positional relationships shown in the accompanying drawings, and are only for the convenience of describing the present invention and simplifying the description, and do not indicate or imply that the device or element referred to must have a specific orientation, be constructed and operated in a specific orientation, and therefore cannot be understood as limiting the present invention. In addition, the terms "first", "second" and "third" are used for descriptive purposes only and cannot be understood as indicating or implying relative importance. Physical quantities in formulas, unless separately marked, should be understood as basic quantities of the International System of Units, or derived quantities derived from basic quantities through mathematical operations such as multiplication, division, differentiation or integration.

[0033] In the description of the present invention, it should be noted that, unless otherwise expressly specified or limited, the terms "mounted," "connected," and "connected" should be understood in a broad sense. For example, they may refer to fixed, detachable, or integral connections; mechanical or electrical connections; direct or indirect connections through an intermediate medium; and internal communication between two components. Those skilled in the art will understand the specific meanings of the above terms in the present invention based on the specific circumstances.

[0034] like Figure 1 、 Figure 2 、 Figure 3As shown, the balloon catheter provided by an embodiment of the present invention includes: an outer tube 100, an inner tube 200, an end tube 300 and a balloon 400; the inner tube 200 passes through the inner cavity of the outer tube 100, and a first channel 500 is formed between the inner wall of the outer tube 100 and the outer wall of the inner tube 200; the end tube 300 is connected to the distal end of the inner tube 200, and the balloon 400 is sleeved on the outside of the inner tube 200, the distal end of the balloon 400 is connected to the distal end of the inner tube 200 or the end tube 300, the proximal end of the balloon 400 is connected to the outer tube 100, and the balloon 400 is fluidically connected to the first channel 500; the inner tube 200 is provided with a second channel 201 extending axially, and the side wall of the inner tube 200 is provided with at least one side opening 202, and the second channel 201 is connected to the balloon 400 through the side opening 202.

[0035] Specifically, the liquid medium is injected through the second channel 201 and discharged through the first channel 500. The second channel 201, the side opening 202, the inner cavity of the balloon 400, and the first channel 500 together constitute a circulation channel. When using the balloon catheter, the liquid medium can be continuously infused, thereby realizing real-time flow replacement of the liquid medium inside the balloon 400, which can prevent bubbles from accumulating inside the balloon and has a flushing effect on the inner cavity of the balloon, thereby preventing bubbles and impurities from accumulating inside the balloon and affecting the function and effectiveness of the product.

[0036] like Figure 1 、 Figure 2 、 Figure 3 and Figure 4 As shown, in the embodiment of the present invention, the ratio of the length l of the side opening 202 to the diameter d of the side opening 202 is less than or equal to 0.5, or greater than 0.5 and less than or equal to 4. In the embodiment where the diameter of the side opening 202 gradually decreases from the inside to the outside, the diameter d of the side opening 202 represents the inner end diameter of the side opening 202.

[0037] Specifically, the length l of the side opening 202 is equal to the wall thickness of the inner tube 200. When l / d ≤ 0.5, it is called a thin-walled small hole; when 0.5 < l / d ≤ 4, it is called a thick-walled hole; when l / d > 4, it is called a slender hole. In this embodiment, thin-walled small holes and thick-walled holes are selected. Under the same pressure difference, the flow rate of the thick-walled hole is greater than that of the thin-walled hole. The greater the pressure difference, the more significant the flow rate advantage of the thick-walled hole (see Figure 6 ).

[0038] Preferably, the ratio of the length l of the side opening 202 to the diameter d of the side opening 202 is greater than 0.5 and less than or equal to 4. The inner tube wall thickness of the balloon catheter provided by this solution can be set within a smaller parameter range, which is conducive to the use of the balloon catheter. In addition, the diameter of the side opening 202 gradually decreases from the inside to the outside along the wall thickness direction. The diameter D of the inner tube 200 is much larger than the diameter d of the side opening 202. When the fluid flows through the side opening 202, the liquid in the inner tube 200 converges toward the side opening 202. The outer end diameter d0 of the side opening 202 and the inner end diameter d of the side opening 202 are smaller than the diameter d of the end (outer end) of the side opening 202 facing the inner cavity of the balloon 400. Therefore, the fluid flowing through the side opening 202 forms a gradual contraction trend, and the liquid flowing through the side opening 202 first contracts and then diffuses, thereby achieving a dispersed flow of the liquid medium into the interior of the balloon 400.

[0039] It should be noted that, in the present invention, there is no special limitation on the number and distribution positions of the side openings 202 .

[0040] Preferably, the ratio of the sum of the minimum areas of the plurality of side openings 202 along the inner tube wall thickness direction to the area of ​​the first channel 500 is in the range of 1:4 to 1:1.

[0041] Preferably, the side opening 202 is located at the distal end of the balloon lumen. This solution is conducive to the full replacement of the liquid medium.

[0042] like Figure 1 、 Figure 2 、 Figure 3 and Figure 4 As shown, the side opening 202 is located at the distal end of the inner cavity of the balloon 400. The fluid entering the inner cavity of the balloon 400 from the side opening 202 flows toward the proximal end, thereby filling the balloon 400 and replacing the original liquid medium in the inner cavity of the balloon 400. In this way, the fluid in the inner cavity of the balloon 400 can be fully replaced, and the bubbles in the inner cavity of the balloon 400 can be fully discharged, and the shock wave conduction effect can be prevented from being affected by the accumulation of too many bubbles on the outside of the shock wave generator 600.

[0043] The ratio of the area of ​​the second channel 201 to the first channel 500 on the cross section perpendicular to the axis of the outer tube 100 is 1:4 to 1:1. The liquid medium flows into the second channel 201 and flows out through the first channel 500. The cross-sectional area of ​​the second channel 201 is 1mm 2 ~9mm 2When the cross-sectional area ratio of the second channel 201 to the first channel 500 is between 1:4 and 1:1, the fluid medium can be ensured to flow out fully. Furthermore, it should be noted that the cross-sectional area of ​​the first channel 500 should not be too large. The maximum cross-sectional area of ​​the first channel 500 is four times that of the second channel 201. This ensures that the fluid in the inner cavity of the balloon 400 maintains a certain pressure during the circulation of the fluid medium. On this basis, the proximal and distal ends of the balloon 400 are respectively configured as conical structures, which not only facilitates the expansion and contraction of the balloon 400, but also the conical structure at the proximal end can guide the fluid inside the balloon 400, thereby directing the liquid medium and bubbles in the inner cavity of the balloon 400 to the first channel 500 and out.

[0044] like Figure 1 、 Figure 3 As shown, a shock wave generator 600 is mounted on the inner tube 200 and is located inside the balloon 400. The shock wave generator 600 may include multiple electrode pairs spaced apart along the axial direction of the inner tube 200. The discharge of the electrode pairs generates shock waves that are transmitted to the outside through the liquid medium in the inner cavity of the balloon 400. The shock waves act on the balloon wall and the calcified lesion, thereby softening the calcified lesion area.

[0045] like Figure 1 and Figure 2 As shown, the inner tube 200 is provided with a first guide wire lumen 203 , and the terminal tube 300 is provided with a second guide wire lumen communicated with the first guide wire lumen 203 .

[0046] Guidewire lumen Figure 1 、 Figure 5 As shown, the balloon catheter further includes a catheter adapter 700, which is connected to the proximal ends of the outer tube 100 and the inner tube 200. The catheter adapter 700 is provided with a filling port 701 and a liquid withdrawal port 702. The filling port 701 is in fluid communication with the second channel 201, and the liquid withdrawal port 702 is in fluid communication with the first channel 500. In this embodiment, after the balloon catheter is implanted at the lesion site, the liquid withdrawal port 702 can be blocked first, and then a liquid medium can be injected through the filling port 701. The liquid medium is then injected into the lumen of the balloon 400 through the second channel 201 and the side opening 202 under the injection pressure, and then discharged through the first channel 500 and the liquid withdrawal port 702, thereby achieving continuous replacement of the fluid in the lumen of the balloon 400 and preventing the accumulation of bubbles inside the balloon 400. A liquid withdrawal pump can also be used to withdraw liquid from the liquid withdrawal port 702 to further accelerate the outflow of the liquid medium.

[0047] like Figure 1 、 Figure 2 and Figure 5As shown, the catheter adapter 700 is further provided with a guidewire port 703 communicating with the first guidewire lumen 203. The guidewire passes through the second guidewire lumen of the terminal tube 300 into the first guidewire lumen 203 and then exits from the guidewire port 703 of the catheter adapter 700. The balloon catheter can be guided along the guidewire to be implanted at the lesion site.

[0048] like Figure 1 、 Figure 2 and Figure 3 As shown, the inner tube 200 is further provided with a first wire cavity 204, and the catheter seat 700 is further provided with a second wire cavity 704. The second wire cavity 704 is communicated with the first wire cavity 204 and is used to pass a wire 800 electrically connected to the shock wave generator 600. The shock wave generator 600 can be powered by a high-voltage power supply device via the wire 800.

[0049] Furthermore, a developing ring (not shown in the figure) can be provided inside the balloon 400 , and the developing ring can be connected to the inner tube 200 . The position of the developing ring can be detected by imaging, thereby knowing the implantation position of the balloon 400 .

[0050] refer to Figure 7 、 Figure 8 and Figure 9 The second embodiment of the present invention provides another balloon catheter, which is different from the first embodiment in that only a second channel 201 is provided in the inner tube 200 of this embodiment, and a first guidewire cavity and a first guidewire cavity are not provided; a filling port 701 and a liquid withdrawal port 702 are provided on the catheter seat 700, and no additional guidewire port is required.

[0051] In this embodiment, the entrance of the second guidewire lumen on the terminal tube 300 is located at the distal end of the terminal tube 300, and the exit is located on the sidewall of the proximal end of the terminal tube 300. The guidewire 900 enters through the entrance of the second guidewire lumen, exits from the exit of the second guidewire lumen, and extends from the outside of the balloon 400 to the proximal end of the balloon catheter.

[0052] In this embodiment, the wire can be directly disposed in the second channel 201 without additionally providing a wire cavity.

[0053] Finally, it should be noted that the above embodiments are only used to illustrate the technical solutions of the present invention, rather than to limit it. Although the present invention has been described in detail with reference to the above embodiments, those skilled in the art should understand that they can still modify the technical solutions described in the above embodiments, or replace some or all of the technical features therein with equivalents. However, these modifications or replacements do not cause the essence of the corresponding technical solutions to deviate from the scope of the technical solutions of the embodiments of the present invention.

Claims

1. A balloon catheter, characterized in that: include: outer tube, inner tube, terminal tube and balloon; The inner tube passes through the inner cavity of the outer tube, and a first channel is formed between the inner wall of the outer tube and the outer wall of the inner tube; The terminal tube is connected to the distal end of the inner tube, the balloon is sheathed on the outside of the inner tube, the distal end of the balloon is connected to the distal end of the inner tube or the terminal tube, the proximal end of the balloon is connected to the outer tube, and the balloon is in fluid communication with the first channel; The inner tube is provided with a second channel extending in the axial direction, and the side wall of the inner tube is provided with at least one side opening, and the second channel is connected with the balloon through the side opening; The diameter of the side opening gradually decreases from inside to outside along the wall thickness direction; The ratio of the length of the side opening to the inner end diameter of the side opening is less than or equal to 0.5, or greater than 0.5 and less than or equal to 4; The ratio of the sum of the minimum areas of the plurality of side openings along the inner tube wall thickness direction to the area of ​​the first channel is in the range of 1:4 to 1:1; the ratio of the area of ​​the second channel to the first channel on the cross section perpendicular to the axis of the outer tube is in the range of 1:4 to 1:1, and the cross-sectional area of ​​the second channel is 1mm 2 ~9mm 2 ; A liquid medium can be injected into the balloon through the second channel, and the liquid medium can be discharged through the first channel, forming a circulation channel through the second channel, the side opening, the balloon lumen, and the first channel.

2. The balloon catheter according to claim 1, characterized in that The side opening is located at the distal end of the balloon lumen.

3. The balloon catheter according to claim 1, characterized in that A shock wave generator is installed on the inner tube and is located inside the balloon.

4. The balloon catheter according to claim 1, characterized in that The inner tube is provided with a first guidewire cavity, and the terminal tube is provided with a second guidewire cavity communicated with the first guidewire cavity. The first guidewire cavity and the second guidewire cavity are connected to each other for inserting a guidewire. The balloon catheter according to claim 1 , wherein: The balloon catheter further comprises a catheter seat, wherein the catheter seat is connected to the proximal ends of the outer tube and the inner tube; The catheter seat is provided with a liquid filling port and a liquid withdrawal port, the liquid filling port is in fluid communication with the second channel, and the liquid withdrawal port is in fluid communication with the first channel. The balloon catheter according to claim 5 , wherein: The catheter seat is also provided with a guide wire port communicated with the inner tube.

7. The balloon catheter according to claim 5, characterized in that A first guide wire cavity is provided in the inner tube, and a second guide wire cavity communicating with the first guide wire cavity is provided on the catheter seat.

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