Bending-controllable balloon plugging micro-catheter

Abstract

The utility model discloses a controllable bending balloon plugging micro-catheter, which relates to the technical field of interventional catheters, and comprises an integral balloon structure and a controllable bending structure, wherein the integral balloon and the catheter outer layer are integrally formed and are not bonded or welded to the catheter, so that the strength of the balloon can be improved, and the use risk in a high-pressure environment can be reduced; the controllable bending structure achieves bending control of the far end of the catheter body, the efficiency of the catheter passing through a human body lumen can be improved, then the operation success rate and the treatment precision are improved, and the operation risk and equipment failure loss are reduced.

Description

TECHNICAL FIELD

[0001] The present application relates to the technical field of interventional catheter, in particular to a controllable bent balloon occlusion microcatheter. BACKGROUND

[0002] Interventional catheter is an indispensable auxiliary tool in human body septum puncture, cardiovascular intervention, peripheral vascular intervention, heart atrial septostomy, renal artery ablation, heart valve repair, tumor interventional embolization and other interventions with bifurcated blood vessels and requiring precise positioning of human body lumen intervention surgery. Usually, a pre-plasticity catheter is used to pre-establish a channel from the outside to the target position, providing a channel for subsequent guide wire or other instruments to enter for diagnosis and treatment. However, due to the individual differences in human body structure, the pre-plasticity catheter cannot completely meet all clinical needs. Once the inserted catheter does not meet the physiological structure of the patient, it needs to be withdrawn and a new catheter is inserted, which will increase the operation time and may cause harm to the patient.

[0003] In order to adapt to the individual differences of human body anatomy, controllable bent catheters have emerged and been widely used. The controllable bent catheter is a catheter with a controllable bent segment at the distal end of the catheter body. By controlling the handle of the catheter to drive the traction line connected to the controllable bent segment to move axially, the distal end of the catheter body can be bent to different angles. When the bending angle of the controllable bent segment meets the specific physiological structure characteristics of the human body lumen, the handle is stopped. At this time, the distal end of the catheter body is aligned with the target lumen inlet, and then the diagnostic and / or therapeutic instruments / mediums are delivered to the target lumen through the catheter body.

[0004] Tumor interventional embolization, aneurysm embolization, Marshall anhydrous alcohol ablation and other interventional procedures usually use balloon occlusion microcatheters to infuse media and / or liquid and / or embolic materials and / or appropriate instruments (such as stents, spring coils) through the microcatheter, and to temporarily occlude peripheral blood vessels or neurovasculars or selectively block or control blood flow through the microcatheter distal end inflatable and deflatable balloon. The balloon occlusion microcatheter belongs to a kind of microcatheter, which is a kind of interventional catheter, has a very small diameter, and has no strict size definition. Empirically, small catheters with a diameter of 0.70-1.30 mm are called microcatheters. Microcatheters generally have a reinforced multi-layer composite structure and are commonly used in fine vascular interventional therapy.

[0005] The conventional balloon occlusion microcatheter connects or attaches the balloon to the microcatheter body by means of adhesion or welding, which not only increases the complexity of the balloon occlusion microcatheter manufacturing process, but also has the risk of unstable connection structure of the balloon in high-pressure environment or complex working environment. At the same time, due to the precision characteristics of the microcatheter itself and the special structure with the balloon, the controllable bending of the balloon occlusion microcatheter has great difficulty in structure, strength and process implementation. The existing conventional balloon occlusion microcatheter cannot change the distal end of the microcatheter into a suitable curved shape to pass through the small and winding body lumen like the controllable bending conventional catheter of larger size, so the current operator has great difficulty in operation, the treatment accuracy needs to be improved, and there is a risk of surgery and equipment failure. SUMMARY

[0006] The purpose of the present application is to overcome the shortcomings of the prior art and provide a controllable bending balloon occlusion microcatheter, which comprises an integrated balloon structure and a controllable bending structure. The integrated balloon is integrally formed with the outer layer of the catheter and is not adhered or welded to the catheter, which can reduce the complexity of the balloon microcatheter manufacturing process and reduce the risk of balloon use in high-pressure environment; the controllable bending structure can control the bending degree of the distal end of the catheter, improve the efficiency of the catheter passing through the body lumen, and thus improve the success rate of surgery and treatment accuracy, reduce the risk of surgery and equipment failure.

[0007] To achieve the above-mentioned purpose, the present application provides a controllable bending balloon occlusion microcatheter, which comprises a catheter body and a controllable bending base. The catheter body is a multi-layer structure comprising a catheter inner layer, a catheter intermediate layer and a catheter outer layer, all of which are made of high molecular polymer material, wherein the catheter inner layer forms an infusion lumen, and the catheter intermediate layer and the catheter outer layer form an inflation lumen; the proximal end of the catheter body is a non-bendable section, and the distal end of the catheter body is a bendable section.

[0008] The catheter outer layer is provided with an integrated balloon, and the catheter outer layer can be divided into a non-balloon proximal section, a balloon section and a non-balloon distal section. The balloon section is a balloon with elasticity and inflation and contraction. The balloon is integrally formed with the catheter outer layer, and the balloon is not adhered or welded to the catheter. The balloon has a smooth surface, and the balloon is completely attached to the catheter intermediate layer in the un-inflated state.

[0009] The catheter intermediate layer is internally provided with at least one traction line, and the traction line is externally provided with a limiting tube sleeve. The traction line is connected to the distal end of the catheter intermediate layer. The controllable bending base is provided with a drug and instrument infusion interface, a medium infusion interface and a traction control bending mechanism. The controllable bending base controls the bendable section of the catheter body through the traction line. The drug and instrument infusion interface connects the infusion lumen, and the medium infusion interface connects the inflation lumen.

[0010] In some embodiments, a metal reinforcing layer is provided between the inner layer and the intermediate layer of the catheter, and the metal reinforcing layer is configured as a metal braided tube, a metal spring tube, a metal hypotube, or a composite tube formed by connecting a metal spring tube and a hypotube in series.

[0011] In some embodiments, the intermediate layer of the catheter comprises a metal braided layer and a polymer layer, and the metal braided layer and the polymer layer are combined to form an integrated composite structure.

[0012] In some embodiments, the polymer material used in the inner layer, the intermediate layer, the outer layer of the catheter, and the limiting tube sleeve comprises one or more of Nylon, PEBAX, PEU, PTFE, PU, PI, or PEEK.

[0013] In some embodiments, when the balloon is in an unexpanded state, the difference between the outer diameter of the balloon segment of the outer layer of the catheter and the outer diameters of the non-balloon proximal segment and the non-balloon distal segment is less than 0.1 mm.

[0014] In some embodiments, the distal end of the intermediate layer of the catheter is provided with a positioning component, the positioning component is in the shape of a circular ring and is sleeved on the intermediate layer of the catheter, and the positioning component is made of a radiopaque material; the pull wires are uniformly distributed in the circumferential direction of the central axis of the intermediate layer of the catheter, the pull wires are connected to the positioning component, and the connection points are uniformly distributed along the positioning component, and the connection mode includes welding or winding.

[0015] In some embodiments, the distal end of the intermediate layer of the catheter is not provided with a positioning component, the pull wires are uniformly distributed in the circumferential direction of the central axis of the intermediate layer of the catheter, and the pull wires are fixedly connected to the distal end of the intermediate layer of the catheter by winding; in a further aspect, when a plurality of pull wires are fixedly connected to the distal end of the intermediate layer of the catheter by winding, different pull wires can control the bendable segment of the catheter body to bend in different directions.

[0016] In some embodiments, the balloon is internally provided with a first radiopaque ring and a second radiopaque ring, the first radiopaque ring is located at the abutting position of the non-balloon proximal segment and the balloon segment of the outer layer of the catheter, and the second radiopaque ring is located at the abutting position of the balloon segment and the non-balloon distal segment of the outer layer of the catheter.

[0017] In some embodiments, the traction bending control mechanism comprises a manual bending control component and a locking component, the manual bending control component drives the displacement of the pull wires to drive the bending of the bendable segment of the catheter body, and the locking component comprises two states of locking and opening, and when the locking component is in the locking state, the movement of the manual bending control component is limited.

[0018] In some embodiments, the manual bending control component and the locking component are designed as an operable mechanical structure, and the mechanical structure can be a rotating wheel, a knob, or a slide button.

[0019] In some embodiments, the outer layer of the catheter comprises a plurality of non-adjacent balloon segments, each balloon segment exhibiting an elastic, collapsible balloon, and the plurality of balloons are in communication with the inflation lumen. In further aspects, the plurality of balloons can be simultaneously in an inflated state.

[0020] In some embodiments, the drug and media infusion interfaces are luer connectors.

[0021] In some embodiments, the intermediate layer of the catheter has two non-adjacent positioning components at the distal end, each positioned at a different portion of the bendable segment of the catheter body, and the pull wires are connected to the positioning components to control the bends of the catheter body, respectively.

[0022] Due to the use of the above technical solutions, the present application has the following beneficial effects compared with the prior art. On the one hand, the controllable bend balloon occlusion microcatheter adopts a whole balloon structure, the balloon segments of the outer layer of the catheter exhibit elastic, collapsible balloons, the balloon and the outer layer of the catheter are integrally formed and are not bonded or welded, and in a high-pressure use environment, the whole balloon can exhibit good safety and stability; the balloon and the outer layer of the catheter are integrally formed, which also avoids the cumbersome process of bonding or welding of the traditional balloon. On the other hand, the controllable bend balloon occlusion microcatheter adopts a controllable bend structure, the bending of the bendable segment of the catheter is controlled to improve the efficiency of the catheter through the body lumen, reduce the operation time and operation risk, and thus improve the operation success rate and treatment accuracy. BRIEF DESCRIPTION OF DRAWINGS

[0023] Figure 1 The structure schematic diagram of one embodiment of the controllable bend balloon occlusion microcatheter proposed by the present application;

[0024] Figure 2 The structure schematic diagram of one embodiment of the controllable bend balloon occlusion microcatheter proposed by the present application in the state of balloon inflation, distal bending and locking;

[0025] Figure 3 The catheter body cross-sectional view of one embodiment of the controllable bend balloon occlusion microcatheter proposed by the present application;

[0026] Figure 4 The structure schematic diagram of the outer layer of one embodiment of the controllable bend balloon occlusion microcatheter proposed by the present application;

[0027] Figure 5 The structure schematic diagram of the pull wire, positioning component and limiting tube sleeve in the catheter body of one embodiment of the controllable bend balloon occlusion microcatheter proposed by the present application;

[0028] Figure 6A 、 Figure 6B 、 Figure 6CStructure diagram of the controllable bending and locking principle of the plurality of embodiments of the controllable bending balloon occlusion microcatheter proposed by the present application;

[0029] Figure 7 Structure diagram of the catheter outer layer containing a plurality of non-adjacent balloon segments of one embodiment of the controllable bending balloon occlusion microcatheter proposed by the present application;

[0030] Figure 8 Diagram of the catheter middle layer distal end provided with two positioning components of one embodiment of the controllable bending balloon occlusion microcatheter proposed by the present application.

[0031] Figure 9A 、 Figure 9B 、 Figure 9C Structure diagram of the traction wire and catheter middle layer winding connection of the plurality of embodiments of the controllable bending balloon occlusion microcatheter proposed by the present application.

[0032] List of corresponding feature names of the reference numerals in the drawings:

[0033] 1, controllable bending base; 11, drug and instrument infusion interface; 12, medium infusion interface; 13, traction controllable bending mechanism; 131, manual controllable bending component; 132, locking component;

[0034] 2, catheter body; 21, catheter inner layer; 22, catheter middle layer; 221, traction wire; 222, positioning component; 223, first developing ring; 224, second developing ring; 225, limiting sleeve; 23, catheter outer layer; 231, balloon / balloon segment; 232, non-balloon proximal segment; 233, non-balloon distal segment; 24, metal reinforcing layer; 25, infusion lumen; 26, inflation lumen;

[0035] 3, catheter body bendable segment;

[0036] 4, catheter body unbendable segment. DETAILED DESCRIPTION

[0037] The present application will be further described in detail below through specific embodiments combined with the drawings. In the field of medical devices, the proximal end refers to the end of the medical device controlled by the doctor or outside the human body, and the distal end refers to the other end of the medical device that plays a diagnostic / therapeutic role or is in the human body, thereby extending the definition of the proximal and distal directions, and accordingly naming the distal end and the proximal end of the overall structure or individual parts for convenient detailed description.

[0038] The controllable bending balloon occlusion microcatheter proposed by the present application is used in interventional operations such as tumor interventional embolization, aneurysm embolization, Marshall absolute alcohol ablation, etc., and through infusion of medium and / or liquid and / or embolic material and / or appropriate instruments (such as stents, spring coils), temporary occlusion of peripheral blood vessels or neurovascular vessels, or selective blockage or control of blood flow can be achieved.

[0039] Embodiment of controllable bending balloon occlusion microcatheter in the present application:

[0040] A controllable bending balloon occlusion microcatheter comprises a controllable bending base 1 and a catheter body 2. The controllable bending base 1 is provided with a drug and device infusion interface 11, a medium infusion interface 12 and a traction controllable bending mechanism 13, and the distal end of the controllable bending base 1 is connected to the proximal end of the catheter body 2. The catheter body comprises, from inside to outside, a catheter inner layer 21, a catheter intermediate layer 22 and a catheter outer layer 23. The catheter inner layer 21 and the catheter outer layer 23 are made of soft high polymer material. The catheter inner layer 21 forms an infusion lumen 25, and the catheter outer layer and the catheter intermediate layer form an inflation lumen 26.

[0041] The catheter intermediate layer 22 internally comprises a metal braid layer and a high polymer layer, which are combined with each other to form an integrated composite structure. The catheter intermediate layer 22 is provided with a limiting sleeve 225 in the middle, the limiting sleeve 225 is internally provided with a traction line 221, the distal end of the catheter intermediate layer 22 is provided with a positioning component 222, the positioning component 222 is a circular ring component and is made of a developing material, the positioning component 222 is sleeved on the catheter intermediate layer 22, the distal end of the traction line 221 is connected with the positioning component 222 in a welding manner.

[0042] The catheter outer layer 23 is provided with a whole balloon 231, and the catheter outer layer 23 can be divided into a non-balloon proximal section 232, a balloon section 231 and a non-balloon distal section 233. The balloon section 231 is a balloon 231 with elasticity and shrinkable, the balloon 231 is integrally formed with the catheter outer layer 23 and is not bonded or welded to the catheter body 2, the balloon 231 has a smooth surface, and the balloon 231 completely adheres to the catheter intermediate layer 22 in the unexpanded state; the inflation lumen 26 is in communication with the balloon 231 and the medium infusion interface 12, when the fluid medium passes through the medium infusion interface 12 and reaches the balloon 231 through the inflation lumen 26, the balloon 231 no longer adheres to the catheter intermediate layer 22 to form a circumferential expansion state, thereby adhering to the inner wall of the human body lumen to play a role of temporarily occluding the peripheral blood vessels or neurovascular vessels, and the control of the filling and unloading of the fluid medium is the control of the blood flow blockage and flow.

[0043] When the balloon 231 is in the unexpanded state, the outer diameter of the balloon section 231 of the catheter outer layer 23 is equal to the outer diameters of the non-balloon proximal section 232 and the non-balloon distal section 233 of the catheter outer layer 23.

[0044] The traction control bending mechanism 13 comprises a manual bending control component 131 and a locking component 132. The manual bending control component 131 is connected to the proximal end of the traction line 221, and drives the traction line 221 to displace the proximal end to realize the bending of the bendable section 3 in the catheter body 2. When the length of the traction line 221 remaining in the catheter body 2 is shortened by displacement, the positioning component 222 in the catheter body 2 bends towards the side of the traction line 221, so that the catheter body 2 is bent. When the locking component 132 is in the open state, the manual bending control component 131 can move freely to change the displacement of the traction line 221. When the locking component 132 is in the locked state, the manual bending control component 131 is limited to move and limit the displacement of the traction line 221.

[0045] The first developing ring 223 and the second developing ring 224 are arranged inside the balloon 231, and the first developing ring 223 and the second developing ring 224 are arranged inside the catheter intermediate layer 22. The first developing ring 223 is located at the position adjacent to the non-balloon proximal section 232 and the balloon section 231 of the catheter outer layer 23, and the second developing ring 224 is located at the position adjacent to the balloon section 231 and the non-balloon distal section 233 of the catheter outer layer 23.

[0046] In a specific embodiment, the metal braid layer inside the catheter intermediate layer 22 is a composite structure formed by connecting a metal spring tube and a metal hypotube in series. The high polymer material of the catheter inner layer 21 can be selected from PTFE, PU, PEBAX, PI, Nylon or PEEK. The material of the high polymer layer of the catheter intermediate layer 22 can be selected from Nylon, PEBAX or PEU. The material of the metal braid layer of the catheter intermediate layer 22 can be selected from nickel-titanium, stainless steel or tungsten. The high polymer material of the catheter outer layer 23 can be selected from HDPE, PTFE, PEBAX, PI, PU, silicone rubber or PEU. The material of the limiting tube sleeve 225 can be selected from PTFE or UHMW-PE.

[0047] In a specific embodiment, the catheter intermediate layer 22 is provided with two limiting sleeve tubes 225, which are symmetrically distributed in the catheter intermediate layer 22. Two traction lines 221 are respectively arranged inside the two limiting sleeve tubes 225, and the two traction lines are respectively connected to the circular ring-shaped positioning component 222 by welding, and the connection points are symmetrically distributed. The manual bending control component 131 can independently control the two traction lines 221 to realize the bending of the bendable section of the catheter body 2 in different directions.

[0048] In a specific embodiment, the intermediate layer 22 of the catheter is provided with two non-adjacent positioning components 222 at the distal end, and the intermediate layer 22 is provided with two limiting sleeves 225 symmetrically distributed therein, and the two limiting sleeves 225 are respectively provided with two traction lines 221 inside, and the two traction lines 221 are respectively connected with the two positioning components 222, and the traction control bending mechanism 13 can independently control the two traction lines 221 to realize the bending of the plurality of bendable segments of the catheter body 2 at the same time.

[0049] In a specific embodiment, the outer layer 2 of the catheter is provided with a plurality of non-adjacent balloon segments 231, that is, the plurality of balloon segments 231 and a plurality of non-balloon segments are connected in series to form an integrally formed outer layer 2 of the catheter; each balloon segment 231 is a balloon 231 with elasticity and can be expanded and contracted, and the plurality of balloons 231 are connected with the inflation lumen 26. When the fluid medium reaches the plurality of balloons 231 through the medium infusion interface 12 via the inflation lumen 26, the plurality of balloons 231 no longer adhere to the intermediate layer 22 to form a circumferential expansion state, and then fit the inner wall of the multi-segment human body lumen to realize precise plugging of a specific lumen segment.

[0050] In some specific embodiments, in order to avoid the influence of the positioning components 222 on the process difficulty, structural strength and balloon shape performance in the segment where the balloon 231 is located, preferably, the positioning components 222 are located in the non-balloon distal segment 233 of the outer layer 23 of the catheter.

[0051] In some specific embodiments, the drug infusion interface 11 and the medium infusion interface 12 are both luer joints to facilitate connection in a unified specification.

[0052] In the description of the embodiments of the present application, the terms related to the description of the direction and position relationship such as "upper", "lower", "bottom", "inner" and "outer" are only for the convenience of describing the present application, and cannot be understood as a limitation on the present application.

[0053] In the related description of the present application, unless otherwise explicitly stated, the terms related to "connection", "connection" and the like should be understood in a broad sense, including but not limited to fixed connection, detachable connection, integral connection, indirect connection through a medium, or mechanical connection, electrical connection, conductive component communication.

[0054] The embodiments of the present application are only for the purpose of illustrating the technical concept and characteristics of the present application, and the purpose is to enable those skilled in the art to understand the content of the present application and implement it, and cannot limit the protection scope of the present application. Any equivalent changes or modifications made in accordance with the spirit and essence of the present application should be covered within the protection scope of the present application.

Claims

1. A controllable curved balloon occlusion microcatheter, characterized in that, Includes the catheter body and the controllable bending base; The catheter body includes an inner layer, a middle layer, and an outer layer. The inner layer, the middle layer, and the outer layer are made of a high molecular polymer material. The inner layer forms an infusion lumen, and the middle layer and the outer layer form an expansion lumen. The proximal end of the catheter body is an inflexible section, and the distal end of the catheter body is a flexible section; The outer layer of the catheter is provided with an integral balloon, which can be divided into a non-balloon proximal section, a balloon section and a non-balloon distal section. The balloon section is an elastic, expandable balloon, wherein the balloon is integrally formed with the outer layer of the catheter, the balloon has a smooth surface, and the balloon is completely attached to the middle layer of the catheter when it is not inflated. At least one traction wire is provided inside the intermediate layer of the catheter, and a limiting sleeve is provided outside the traction wire. The traction wire is connected to the distal end of the intermediate layer of the catheter. The controllable bending base is provided with a drug infusion interface, a medium infusion interface and a traction bending mechanism. The controllable bending base controls the bendable section of the catheter body via the traction line. The drug infusion interface is connected to the infusion lumen and the medium infusion interface is connected to the expansion lumen.

2. The controllable curved balloon occlusion microcatheter according to claim 1, characterized in that, A metal reinforcing layer is provided between the inner layer of the catheter and the middle layer of the catheter. The metal reinforcing layer is configured as a metal braided tube, a metal spring tube, a metal thiopan tube, or a composite tube formed by connecting a spring tube and a thiopan tube in series.

3. The controllable curved balloon occlusion microcatheter according to claim 1, characterized in that, The inner layer of the catheter includes a metal braided layer and a polymer layer, which are combined to form an integrated composite structure.

4. The controllable curved balloon occlusion microcatheter according to claim 2 or 3, characterized in that, When the balloon is in an uninflated state, the difference between the outer diameter of the balloon segment of the outer layer of the catheter and the outer diameter of the proximal and distal non-balloon segments is less than 0.5 mm.

5. The controllable curved balloon occlusion microcatheter according to claim 4, characterized in that, The distal end of the intermediate layer of the catheter is provided with a positioning component. The positioning component is circular in shape and is sleeved on the intermediate layer of the catheter. The positioning component is made of radiopaque material. The traction wires are evenly distributed circumferentially in the intermediate layer of the catheter. The traction wires are connected to the positioning component, and the connection points are evenly distributed along the positioning component. The connection method includes welding or wrapping.

6. The controllable curved balloon occlusion microcatheter according to claim 4, characterized in that, No positioning component is set at the distal end of the intermediate layer of the catheter. The traction wires are evenly distributed circumferentially along the central axis of the intermediate layer of the catheter, and the distal end of the traction wires is fixedly connected to the intermediate layer of the catheter by winding.

7. The controllable curved balloon occlusion microcatheter according to claim 5 or 6, characterized in that, The balloon is provided with a first radiopaque ring and a second radiopaque ring. The first radiopaque ring is located at the junction of the non-balloon proximal segment and the balloon segment on the outer layer of the catheter, and the second radiopaque ring is located at the junction of the balloon segment and the non-balloon distal segment on the outer layer of the catheter.

8. The controllable curved balloon occlusion microcatheter according to any one of claims 1-7, characterized in that, The traction bending control mechanism includes a manual bending control component and a locking component. The manual bending control component drives the traction line to move so as to drive the bendable section of the conduit body to bend. The locking component has two states: locked and unlocked. When the locking component is in the locked state, it restricts the movement of the manual bending control component.

9. The controllable curved balloon occlusion microcatheter according to claim 8, characterized in that, The manual bending control component and the locking component are designed as operable mechanical structures, which may employ a wheel, knob, or slide.

10. The controllable curved balloon occlusion microcatheter according to claim 8, characterized in that, The outer layer of the catheter includes multiple non-adjacent balloon segments, each of which is an elastic, expandable balloon, and each balloon is connected to the expandable lumen.

11. The controllable curved balloon occlusion microcatheter according to claim 8, characterized in that, Both the drug infusion interface and the medium infusion interface are Luer connectors.

12. The controllable curved balloon occlusion microcatheter according to claim 5, characterized in that, The distal end of the intermediate layer of the catheter is provided with two non-adjacent positioning components. Each positioning component is located at a different position in the flexible section of the catheter body. The traction line is connected to the positioning component to control multiple bends of the catheter body.

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