A balloon for expanding vesicle-type string valve

Abstract

The present invention relates to the technical field of medical device implants, and in particular to a balloon expansion balloon for a vesicle-type string valve, comprising a central catheter and a plurality of split balloons sequentially connected in series along the axis direction of the central catheter, wherein the interiors of the plurality of split balloons are respectively connected to the lumen of the central catheter; the central catheter is connected to an external fluid delivery device, and the plurality of split balloons are pressurized or depressurized by the external fluid delivery device. The balloon expansion balloon for a vesicle-type string valve of the present invention has a simple manufacturing process and low manufacturing cost. Its structure can be used to successfully locate the position of the aorta, further increase the internal pressure of the balloon to expand the deformed or narrowed valve, destroy the calcified valve, and restore its elasticity; pre-expand the native valve to prepare for artificial valve replacement, and at the same time, the compliance and adaptability are extremely high, reducing the adverse effects of excessive balloon expansion and balloon sliding, reducing the possibility of complications or damage, and is easy to operate, thereby improving the success rate of the operation.

Description

Technical Field

[0001] The invention relates to the technical field of medical device implants, and in particular to an expansion balloon for a vesicle-type string valve. Background Art

[0002] Aortic valve stenosis is a common cause of acquired heart disease. A large part of the root cause is that the valve is calcified and rigid, and its ability to open and close is limited, which results in obstruction of the antegrade flow of blood through the heart. When the valvular leaflets become very severe, invasive measures such as aortic dilation or valve replacement are usually required for treatment. The existing technology mainly uses catheter-based minimally invasive balloon valvuloplasty to expand the valve leaflets. The principle is that during the treatment process, a balloon catheter is inserted into a vein or artery and pushed forward until it reaches the heart valve that needs treatment. Fluid is injected into the balloon to expand it, so as to expand the diseased valve to open it, destroy the hardened calcium sheets, and restore the elasticity of the valve leaflets. The degree of expansion of the balloon depends on the severity of the disease. After the valve leaflets are expanded, the fluid in the balloon is expelled to shrink it, and then it is removed from the cardiovascular system. Reference is made to the patent document with application number 2017103073972, which discloses a balloon catheter for expanding the aortic valve and its inflation device, wherein the balloon catheter includes a catheter, and a balloon located at the distal end of the catheter, the balloon includes an inner balloon and an outer balloon nested inside and outside, the inner balloon and the outer balloon are provided with independent expansion cavities, the outer balloon includes a distal part, a waist and a proximal part arranged in sequence along the axis of the catheter, in the expanded state, the diameter of the waist is smaller than the diameter of the distal part and the proximal part, and the inner balloon expands radially in the fluid-filled state to press against the waist to expand the aortic valve. The proximal and distal ends of the balloon of the prior art need to maintain non-compliance, and the middle needs to maintain semi-compliance. For an integrated balloon, if different materials are used to make different parts respectively, the connection method between different materials should be considered; if the same material is used, different parts need to be treated differently to produce different properties, the overall process is complex, high requirements are placed on process accuracy, and the manufacturing cost is high.

[0003] In view of the above technical problems, it is necessary to improve them. Summary of the invention

[0004] The purpose of the present invention is to provide a balloon expansion for a vesicle-type string valve in view of the defects of the prior art.

[0005] In order to achieve the above purpose, the present invention adopts the following technical solutions:

[0006] A balloon expansion device for a vesicle-type series valve comprises a central catheter and a plurality of separate balloons connected in series in sequence along the axis of the central catheter, wherein the interiors of the separate balloons are respectively connected to the lumen of the central catheter; the central catheter is connected to an external fluid delivery device, and the separate balloons are pressurized or depressurized by the external fluid delivery device.

[0007] As a preferred solution, the plurality of split balloons are all single-layer balloons, or all multi-layer balloons, or a combination of single-layer balloons and multi-layer balloons.

[0008] As a preferred embodiment, the vesicle shape of the split spherical balloon is a combination of one or more of spherical, elliptical, prismatic, and bubble-shaped.

[0009] As a preferred embodiment, the outer surface of the split balloon has texture or a plurality of protrusions.

[0010] As a preferred embodiment, the plurality of split balloons include a proximal balloon, a distal balloon, and an intermediate balloon, and the diameters of the proximal balloon and the distal balloon after being fully inflated are larger than the diameter of the intermediate balloon after being fully inflated.

[0011] As a preferred embodiment, the interiors of the proximal balloon, the distal balloon and the intermediate balloon are connected to the central catheter lumen through valve ports, respectively; a rotary valve is provided in the central catheter, and the rotary valve includes an input end and an output end, and the input end is connected to an external fluid delivery device. By rotating the rotary valve, when the output end coincides with the valve port, the output end is connected to the valve port, and when the output end does not coincide with the valve port, the output end is not connected to the valve port.

[0012] As a preferred embodiment, when the rotary valve rotates to the first position, the valve ports of the proximal balloon and the distal balloon are connected to the output end at the same time, and the valve port of the intermediate balloon is not connected to the output end; when the rotary valve rotates to the second position, the valve port of the intermediate balloon is connected to the output end, and the valve ports of the proximal balloon and the distal balloon are not connected to the output end.

[0013] As a preferred solution, when the split balloon is in a fully punched state, the maximum diameter of the distal balloon is 16-32 mm, the maximum diameter of the middle balloon is 14-30 mm, and the maximum diameter of the proximal balloon is 16-32 mm.

[0014] As a preferred solution, when the split balloon is in a fully punched state, the internal fluid pressure of the proximal balloon and the distal balloon is 1-3 atm, and the internal fluid pressure of the middle balloon is 0.1-1 atm.

[0015] As a preferred solution, the split balloon is composed of a plurality of split small balloons arranged in a ring around a central catheter, and the interiors of the plurality of split small balloons are respectively connected to an external fluid delivery device through the central catheter.

[0016] Compared with the prior art, the vesicle-type string valve expansion balloon of the present invention has a simple manufacturing process and low manufacturing cost. Its structure can be used to successfully locate the position of the aorta, further increase the internal pressure of the balloon to expand the deformed or narrowed valve, destroy the valve calcification, and restore its elasticity; the native valve is pre-expanded to prepare for artificial valve replacement. At the same time, it has extremely high compliance and adaptability, reduces the adverse effects of balloon over-expansion and balloon sliding, reduces the possibility of complications or injuries, is easy to operate, and improves the success rate of the operation. BRIEF DESCRIPTION OF THE DRAWINGS

[0017] Figure 1 It is a front view of the expansion balloon for the vesicle-type string valve according to the first embodiment of the present invention;

[0018] Figure 2 It is a schematic diagram of positioning the expansion balloon of the vesicle-type string valve in the aorta according to the first embodiment of the present invention;

[0019] Figure 3 It is a schematic diagram of a state where the aortic valve is expanded by an expansion balloon of a balloon-type vesicle-type valve according to the first embodiment of the present invention;

[0020] Figure 4 It is an enlarged schematic diagram of a cross section of a central catheter of a balloon for a vesicle-type string valve according to a second embodiment of the present invention;

[0021] Figure 5 is an enlarged schematic diagram of a cross section of a central catheter when the rotary valve of the balloon for the balloon-type cascade valve according to the second embodiment of the present invention is located in the first position;

[0022] Figure 6 It is an enlarged schematic diagram of the cross section of the central catheter when the rotary valve of the balloon expansion valve for the vesicle-type string valve according to the second embodiment of the present invention is in the second position;.

[0023] Figure 7 Schematic diagram of the case where the split balloon of the balloon-type string-type valve expansion balloon of the third embodiment of the present invention is double-layered;

[0024] Figure 8 is an enlarged schematic cross-sectional view of the middle balloon of the balloon-type string valve expansion balloon according to the fourth embodiment of the present invention;

[0025] Among them: 101. distal balloon; 101a. distal inner balloon; 102. middle balloon; 102a. split small balloon; 103. proximal balloon; 104. central catheter; 104a. proximal valve port; 104b. distal valve port; 104c. middle valve port; 105. capillary; 106. left ventricular outflow tract; 107. aortic valve; 108. leaflets; 109. aorta; 110. inner tube; 110a. proximal opening; 110b. distal opening; 110c. middle opening; 111. lumen; 112. rotary valve. DETAILED DESCRIPTION

[0026] The following describes the embodiments of the present invention by specific examples, and those skilled in the art can easily understand other advantages and effects of the present invention from the contents disclosed in this specification. The present invention can also be implemented or applied through other different specific embodiments, and the details in this specification can also be modified or changed in various ways based on different viewpoints and applications without departing from the spirit of the present invention. It should be noted that the following embodiments and features in the embodiments can be combined with each other without conflict.

[0027] Embodiment 1:

[0028] like Figure 1-3 As shown, the expansion balloon for the vesicle-type string valve of this embodiment includes a catheter, and split balloons arranged in sequence along the catheter. The balloons are not interconnected and have independent inner cavities. The split balloons can be directly made of different materials to meet the material compliance requirements of different positions, which is simpler than the process of the integrated balloon.

[0029] Specifically, the split balloon includes a proximal balloon 103, an intermediate balloon 102, and a distal balloon 101. The proximal balloon 103 and the distal balloon 101 are made of non-compliant materials, which may be PET, polytetrafluoroethylene, polyimide, high molecular polymer or fiber material, or compliant or semi-compliant materials may be treated by electron beam, chemical or other cross-linking methods to make them relatively non-compliant. The intermediate balloon 102 is made of semi-compliant materials, which may be nylon, resin, vinyl, PVC, polyethylene, polyurethane, polyetheramide, olefin, etc. Similarly, non-compliant materials may be used to weaken the structure of the material through electron beam, chemical treatment or other processes, so as to make it relatively semi-compliant.

[0030] The proximal balloon 103, the intermediate balloon 102 and the distal balloon 101 are respectively connected in series on the central catheter 104. The balloon is prismatic and round in shape. It is connected to the central catheter 104 cavity through the capillary 105. The central catheter 104 is connected to an external fluid delivery device. The external fluid delivery device is used to inflate or release the pressure of several separate balloons. The fluid control device is equipped with a pressure gauge and a control valve for measuring the pressure in the balloon cavity to control the size of the balloon expansion. When fully inflated and expanded, the diameters of the proximal balloon 103 and the distal balloon 101 are larger than the diameter of the middle balloon 102. Relying on this structure with large ends and a small middle, the balloon can be easily fixed in the position of the valve, reducing the possibility of the overall deviation and sliding of the balloon. At the same time, different balloons rely on different delivery tubes to control fluid delivery, and their expansion and contraction do not interfere with each other, which greatly reduces the possibility of balloon rupture and valve tearing caused by excessive expansion, thereby improving the speed, success rate and safety of the operation. Combined with the average size of human blood vessels and multiple experiments, it has been confirmed that the maximum diameter of the distal balloon 101 is 16-32mm, the maximum diameter of the middle balloon 102 is 14-30mm, and the maximum diameter of the proximal balloon 103 is 16-32mm. The internal fluid pressure of the proximal balloon 103 and the distal balloon 101 is 1-3atm, and the internal fluid pressure of the middle balloon 102 is 0.1-1atm. The expansion balloon for the vesicle-type string valve under this data has the highest adaptability.

[0031] Preferably, the number of the split balloons is more than three, and the vesicle shape of the split balloon is a combination of one or more of spherical, elliptical, prismatic, round, and bubble-shaped, and the graded pressure control is used to obtain various styles of string structures.

[0032] Preferably, the balloon surface is textured or roughened, and the texture may be plain, twill, mesh or threaded, or may be a dispersed arrangement of thorn-shaped or hemispherical protrusions, so as to increase the surface friction after the balloon is inflated, maintain the position of the entire balloon when the valve is expanded, and reduce the possibility of the balloon sliding after being positioned at the aorta 109 due to heart beating or blood pressure. At the same time, the gaps between the textures can reduce the balloon expansion from over-sealing the valve, and avoid hypotension or related complications during surgery caused by prolonged poor blood flow; at the same time, the surface protrusions are more likely to concentrate stress, and compared with the smooth balloon surface, it is more likely to cause valve calcification and rupture even under low pressure.

[0033] Preferably, a developing material is added to the material of the balloon so that the balloon expansion can be observed through a developing device; preferably, some drugs required during the operation can be coated on the outer surface of the balloon, for example, paclitaxel drugs can be used to eliminate local calcification deposited on the valve and promote the rupture of calcified valves.

[0034] Preferably, the two ends of the middle balloon 102 are bonded to the distal balloon 101 and the proximal balloon 103 respectively, and the bonding method includes thermal bonding, solvent bonding or using an adhesive.

[0035] Take aorta 109 as an example, refer to Figure 2 , Figure 3 , specifically describing the implementation status of balloon dilatation of the aortic valve 107.

[0036] Figure 2 The balloon is delivered into the aorta 109 through a conveyor, and the perspective imaging technology is used to position the distal balloon 101 at the left ventricular outflow tract 106 and the intermediate balloon 102 at the aortic valve 107. After the balloon is positioned at the valve, the external fluid delivery device begins to deliver fluid to the distal balloon 101 and the proximal balloon 103 until the internal pressure of the balloon is about 0.1-0.5atm, and the internal pressure of the balloon is slightly higher than the external pressure. By pushing or pulling back the central catheter 104, and coordinating the increase or decrease of the pressure inside the balloon, the intermediate balloon 102 is stabilized as much as possible at the aortic valve 107, so that the entire balloon is in a relatively ideal position. After the positioning is determined, the pressure in the distal balloon 101 and the proximal balloon 103 is further increased to 1-3atm through the external fluid delivery device, so that the balloon is fully expanded and the outer wall of the balloon is against the blood vessel wall. When its diameter is slightly larger than the aorta 109, the entire balloon will not slide away from the relatively narrow aortic valve 107 even if it slides under the blood flow pressure. In addition, its expansion will also be limited by the non-compliant material structure to avoid excessive expansion.

[0037] Figure 3 After expressing the saccule localization, Figure 2 On this basis, the pressure in the middle balloon 102 is increased, so that the middle balloon 102 expands and pushes the leaflets 108 to expand outward, causing them to calcify and crack. The pressure in the middle balloon 102 is gradually increased until the calcified part of the leaflets 108 is fully destroyed. In the artificial valve implantation surgery, in order to determine the diameter of the patient's aortic valve 107 and determine how large the artificial valve is required and the expansion pressure required to fully expand the artificial valve, the pressure in the middle balloon 102 can be further increased to make it fully expand until the waist of the balloon is completely against the aortic valve 107. When the two are completely against each other, the middle balloon 102 is imaged and recorded, and the diameter of the aortic valve 107 is estimated from its expanded size combined with the pressure inside it, and an artificial valve of corresponding size is selected accordingly.

[0038] The vesicle-type string valve expansion balloon of this embodiment has a simple manufacturing process and low manufacturing cost. Its structure can be used to successfully locate the position of the aorta 109, further increase the internal pressure of the balloon to expand the deformed or narrowed valve, destroy the valve calcification, and restore its elasticity; pre-expand the native valve to prepare for artificial valve replacement. At the same time, it has extremely high compliance and adaptability, reduces the adverse effects of balloon over-expansion and balloon sliding, reduces the possibility of complications or injuries, is easy to operate, and improves the success rate of the operation.

[0039] Embodiment 2:

[0040] The difference between the balloon expansion balloon for the vesicle-type string valve of this embodiment and the embodiment 1 is that:

[0041] like Figure 4-6 As shown, the internal structure of the central catheter 104 of this embodiment adopts a rotary valve structure, and the interiors of the proximal balloon 103, the distal balloon 101, and the intermediate balloon 102 are connected to the lumen 111 of the central catheter 104 through valve ports, respectively. The rotary valve 112 includes an input end and an output end, and the input end is connected to an external fluid delivery device. By rotating the rotary valve 112, when the output end coincides with the valve port, the output end is connected to the valve port, and when the output end does not coincide with the valve port, the output end is not connected to the valve port. That is, by rotating the inner tube 110 at the output end of the rotary valve 112, each valve port is aligned with the valve port on the central catheter 104, and then the fluid in the lumen 111 is input or extracted by controlling the delivery device to achieve the expansion or contraction of the balloon.

[0042] like Figure 4 The diagram is a schematic diagram of a state in which all valve ports of the central conduit 104 are closed.

[0043] The inner tube 110 is rotated so that the proximal opening 110a and the distal opening 110b are aligned with the proximal valve port 104a and the distal valve port 104b on the central catheter 104. Figure 5 As shown, when the rotary valve 112 rotates to the first position, a fluid delivery device is used to deliver fluid to the lumen 111 to increase the pressure, so that the fluid in the lumen 111 enters the distal balloon 101 and the proximal balloon 103, and the balloons begin to expand.

[0044] When the distal balloon 101 and the proximal balloon 103 are fully expanded and abut against the blood vessel wall, the inner tube 110 is further rotated. Figure 6As shown, the rotary valve 112 is rotated to the second position, so that the middle opening 110c on the inner tube 110 is aligned with the middle valve port 104c on the central catheter 104. At this time, the proximal valve port 104a and the distal valve port 104b on the central catheter 104 are in a closed state; a fluid delivery device is used to deliver fluid into the lumen 111 to increase the pressure, so that the fluid in the lumen 111 enters the middle balloon 102 to expand the valve. After the valve expansion is completed, the fluid in the lumen 111 is withdrawn to shrink the middle balloon 102 until the pressure in the balloon drops to 0atm; then the inner tube 110 is rotated in the opposite direction to Figure 5 The fluid in the lumen 111 is continuously extracted to shrink the distal balloon 101 and the proximal balloon 103. When the pressure in the balloon returns to 0 atm, the inner tube 110 is rotated to Figure 4 The advantages of this embodiment are that multiple capillaries 105 are prevented from being squeezed by each other when they are simultaneously constrained in the central catheter 104, the assembly structure of the central catheter 104 is simplified, and the expansion and contraction of the distal balloon 101 and the proximal balloon 103 are more synchronous.

[0045] For other structures, please refer to Example 1.

[0046] Embodiment three:

[0047] The difference between the balloon expansion balloon for the vesicle-type string valve of this embodiment and the embodiment 1 is that:

[0048] like Figure 7 As shown, the split balloon of this embodiment forms a double-layer balloon by nesting an additional balloon inside the balloon. At the same time, the inner and outer double-layer balloons are respectively equipped with separate capillaries 105 for partial pressure control. Taking the distal balloon 101 as an example, a distal inner balloon 101a is nested inside it, and the distal balloon 101 and the distal inner balloon 101a control the internal pressure through different capillaries 105 respectively. The inner balloon has semi-compliance, and when fully expanded, such as under a pressure of 1-3atm, its maximum diameter is slightly larger than the maximum diameter of the outer balloon. Compared with Example 1, increasing the number of balloon layers can improve the pressure resistance inside a single balloon and reduce the possibility of balloon explosion; increasing the pressure resistance of the middle balloon 102 can further improve the effect of full expansion of the valve; and at the same time, multiple balloon layers can also prevent ruptured calcified fragments from puncturing the entire balloon. Partial pressure control can more accurately control the size and speed of balloon expansion, avoid instantaneous over-expansion of the balloon to damage the blood vessel wall, and at the same time, the pressure distribution on the balloon surface is more uniform. Similarly, in actual application, in addition to the double-layer balloon, a nested multi-layer balloon implementation method can also be adopted to make the regulation of internal pressure more detailed and accurate.

[0049] For other structures, please refer to Example 1.

[0050] Embodiment 4:

[0051] The difference between the balloon expansion balloon for the vesicle-type string valve of this embodiment and the embodiment 1 is that:

[0052] like Figure 8 As shown, since the area and degree of valve calcification are different in different patients, the cross-sectional structure of the patient's valve ring is generally not a regular circle. Especially for patients with severe calcification, when the valve is expanded and squeezed around the valve ring by the balloon, some irregular hard protrusions will be formed, which will exert a certain pressure on the balloon surface. In addition, the limited compliance of the balloon will make it impossible for the balloon to form an effective fit in the area where the valve calcification is relatively light, which will lead to insufficient expansion. Taking the intermediate balloon 102 as an example, a plurality of split small balloons 102a are arranged in a ring around the central catheter 104, and each small balloon has a capillary 105 connected to the fluid delivery device to control the expansion and contraction of each small balloon. This embodiment adopts a combination of multiple balloons in the same area to solve the problem of fit during balloon expansion for different patients.

[0053] For other structures, please refer to Example 1.

[0054] The specific embodiments described herein are merely examples of the spirit of the present invention. Those skilled in the art may make various modifications or additions to the specific embodiments described or replace them in similar ways, but they will not deviate from the spirit of the present invention or exceed the scope defined by the appended claims.

Claims

1. A balloon for expanding a vesicle-type string valve, characterized in that: It comprises a central catheter and a plurality of split balloons connected in series in the direction of the central catheter axis, wherein the interiors of the plurality of split balloons are respectively connected to the central catheter lumen; the central catheter is connected to an external fluid delivery device, and the plurality of split balloons are pressurized or depressurized by the external fluid delivery device; The plurality of split balloons are all single-layer balloons, or all multi-layer balloons, or a combination of single-layer balloons and multi-layer balloons; The plurality of split balloons include a proximal balloon, a distal balloon, and an intermediate balloon, and the diameters of the proximal balloon and the distal balloon after being fully inflated are larger than the diameter of the intermediate balloon after being fully inflated; The interiors of the proximal balloon, the distal balloon, and the intermediate balloon are respectively connected to the central catheter lumen through valve ports. The central catheter is provided with a rotary valve, which includes an input end and an output end. The input end is connected to an external fluid delivery device. By rotating the rotary valve, when the output end coincides with the valve port, the output end is connected to the valve port, and when the output end does not coincide with the valve port, the output end is not connected to the valve port. The split balloon is composed of a plurality of split small balloons arranged in a ring around a central catheter, and the interiors of the plurality of split small balloons are connected to an external fluid delivery device through the central catheter.

2. A balloon for expanding a vesicle-type string valve as claimed in claim 1, characterized in that: The vesicle shape of the split spherical balloon is a combination of one or more of spherical, elliptical, prismatic, and blister shapes.

3. A balloon for expanding a vesicle-type string valve as claimed in claim 2, characterized in that: The outer surface of the split balloon has textures or a plurality of protrusions.

4. The balloon for expanding a vesicle-type string valve according to claim 1, characterized in that: When the rotary valve rotates to the first position, the valve ports of the proximal balloon and the distal balloon are connected to the output end at the same time, and the valve port of the middle balloon is not connected to the output end; when the rotary valve rotates to the second position, the valve port of the middle balloon is connected to the output end, and the valve ports of the proximal balloon and the distal balloon are not connected to the output end.

5. The balloon for expanding a vesicle-type string valve according to claim 1, characterized in that: When the split balloon is in a fully punched state, the maximum diameter of the distal balloon is 16-32 mm, the maximum diameter of the middle balloon is 14-30 mm, and the maximum diameter of the proximal balloon is 16-32 mm.

6. The balloon for expanding a vesicle-type string valve according to claim 5, characterized in that: When the split balloon is in a fully punched state, the internal fluid pressures of the proximal balloon and the distal balloon are 1-3 atm, and the internal fluid pressure of the middle balloon is 0.1-1 atm.

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