Integrated adjustable bent catheter

Abstract

The integrated bendable catheter comprises an electrode section, a bendable section and a main body section which are sequentially connected from the far end to the near end, the bendable section and the main body section are integrally formed and each comprise a macromolecule inner layer, a braid layer and a macromolecule outer layer which are sequentially stacked from inside to outside, the braid layer of the bendable section is of a structure, and the braid layer of the bendable section is of a structure. The braid layer of the main body section is of a net-shaped braid structure. The integrated bending-adjustable catheter provided by the invention adopts an integrated forming manufacturing method, so that the development cost of raw materials can be reduced, the manufacturing procedures and the assembly difficulty of workers can be reduced, in addition, when the catheter enters a complicated heart structure, a bifurcation of a blood vessel or a special-shaped structure, the catheter is ensured to move smoothly, no damage such as scratching to tissues is caused, and the catheter is suitable for popularization and application. The safety, the effectiveness and the usability of the catheter are improved; the braid layer of the bendable section is of a spiral braid structure, flexibility and resilience are good, and bending can be controlled in place conveniently.

Description

Technical Field

[0001] The present invention relates to the technical field of medical devices, and in particular to an integrated adjustable curved catheter. Background Art

[0002] Vascular intervention technology can effectively treat cardiovascular and cerebrovascular diseases, as well as peripheral vascular diseases, and has the advantages of less trauma and quick recovery. It also has targeted characteristics, which can enable some patients who cannot tolerate surgery or have lost the opportunity for surgery or are drug-resistant to receive effective treatment.

[0003] The heart has a complex structure, and there are safety risks when the catheter enters a bifurcation or atypical structure. Peripheral blood vessels also have branches and bifurcations. For example, the renal artery originates from the abdominal aorta and is divided into two branches at the renal hilum. The starting point of the left renal artery is often higher than the right renal artery. During renal sympathetic denervation ablation, a small incision is made in the groin, and the femoral artery is punctured through the abdominal aorta to enter the left and right renal arteries. During the operation, both left and right renal arteries need to be ablated. After the energy is transmitted to the ablation site for a few seconds, the energy generates heat to denature the tissue and cut off the sympathetic nerves, thereby achieving sympathetic denervation treatment. Currently, most of the catheters on the market are multi-segment adhesives, which have problems such as poor recovery of the bendable section after bending control, low connection strength at the adhesive joint, poor coaxiality and smoothness of the appearance. In the process of delivering the catheter, the vascular wall may be damaged. If the vascular wall is penetrated, it may cause heavy bleeding. In addition, there may be dangerous situations such as vascular dissection. Summary of the invention

[0004] The object of the present invention is to provide an integrated adjustable curved conduit to solve one or more problems in the prior art.

[0005] In order to solve the above problems, the present invention provides an integrated adjustable bend catheter, comprising: an electrode segment, a bendable segment and a main body segment connected in sequence from the distal end to the proximal end, the bendable segment and the main body segment are integrally formed, and both include a polymer inner layer, a braided layer and a polymer outer layer stacked in sequence from the inside to the outside, wherein the braided layer of the bendable segment is a spiral braided structure, and the braided layer of the main body segment is a mesh braided structure.

[0006] Optionally, in the integrated adjustable bend catheter, the electrode segment includes a support tube and an electrode disposed on the support tube;

[0007] The support tube is melt-welded to the distal end of the bendable section; or, the support tube, the bendable section and the main section are integrally formed, and the wire of the electrode extends from the distal end of the support tube into the support tube, and extends to pass through the inner cavity of the support tube, the bendable section and the main section in sequence, until it extends out of the proximal end of the main section.

[0008] Optionally, in the integrated adjustable bend conduit, the support tube is an annular support tube, the annular support tube, the bendable section and the main section are integrally formed, and the braided layer of the annular support tube is the same spiral braided structure as the braided layer of the bendable section.

[0009] Optionally, in the integrated adjustable bend conduit, the electrode is a first electrode, the electrode segment includes a plurality of the first electrodes, and the plurality of the first electrodes are sequentially arranged along the extension direction of the annular support tube.

[0010] Optionally, in the integrated adjustable bend conduit, the electrode segment further includes a temperature sensor, and the temperature sensor is welded to one side of the first electrode close to the annular support tube, and the metal wire of the temperature sensor is used to simultaneously serve as a conductor of the first electrode.

[0011] Optionally, in the integrated adjustable bend catheter, the support tube is a straight support tube, the proximal end of the straight support tube and the distal end of the bendable section are connected by fusion welding for a smooth transition, and the electrode includes a second electrode, which is connected to the distal end of the straight support tube.

[0012] Optionally, in the integrated adjustable bend catheter, the second electrode is bonded to the distal end of the straight support tube, and the gap between the second electrode and the straight support tube is filled with glue.

[0013] Optionally, in the integrated adjustable bend conduit, the electrode further includes a third electrode disposed on the straight support tube.

[0014] Optionally, in the integrated adjustable bend catheter, the bendable section is a single-lumen tube section.

[0015] Optionally, in the integrated adjustable bend conduit, the integrated adjustable bend conduit also includes a handle and at least one pull wire, the handle is connected to the proximal end of the main body section, the proximal end of the pull wire is fixed to the handle, and the distal end of the pull wire is fixed to the bendable section, and the handle controls the bending of the bendable section by driving the pull wire to move.

[0016] In summary, the integrated adjustable bend catheter provided by the present invention comprises: an electrode segment, a bendable segment and a main body segment connected in sequence from the distal end to the proximal end, the bendable segment and the main body segment are integrally formed, and both comprise a polymer inner layer, a braided layer and a polymer outer layer stacked in sequence from the inside to the outside, wherein the braided layer of the bendable segment is a spiral braided structure, and the braided layer of the main body segment is a mesh braided structure. Compared with the prior art, the integrated adjustable bend catheter provided by the present invention has the following beneficial effects:

[0017] (1) The one-piece manufacturing method can reduce the development cost of raw materials, reduce the manufacturing process and the difficulty of assembly for workers. In addition, when the catheter enters the complex heart structure, bifurcation of blood vessels or special-shaped structures, it ensures that the catheter moves smoothly without scratching the tissue, thereby improving the safety, effectiveness and ease of use of the catheter;

[0018] (2) The braided layer of the bendable section adopts a spiral braided structure, which has good softness and resilience, making it easy to control the bending. BRIEF DESCRIPTION OF THE DRAWINGS

[0019] Those skilled in the art will appreciate that the accompanying drawings are provided for a better understanding of the present invention and do not constitute any limitation on the scope of the present invention.

[0020] Figure 1 It is a partial structural schematic diagram of the catheter in the first embodiment of the present invention;

[0021] Figure 2 Schematic diagram of a polymer inner layer, a braided layer and a polymer outer layer in an embodiment of the present invention;

[0022] Figure 3 Schematic diagram of the bending control of the catheter in the second embodiment of the present invention;

[0023] Figure 4 Schematic diagram of two types of bending control bends of the catheter in the third embodiment of the present invention;

[0024] The symbols in the drawings are described as follows:

[0025] 11-main body segment; 12-bendable segment; 13-electrode segment;

[0026] 100- polymer inner layer; 201- spiral braided structure; 202- mesh braided structure; 300- polymer outer layer;

[0027] 131 - annular support tube; 132 - first electrode;

[0028] 140 - straight support tube; 141 - second electrode; 142 - third electrode. DETAILED DESCRIPTION

[0029] The catheter provided by the present invention is an adjustable curved catheter, which uses a pull-wire system to control the distal curvature of the catheter. The distal end of the catheter is provided with an electrode to achieve mapping and / or ablation. The electrode material is a platinum-iridium alloy, and can also be other commonly used electrode materials such as stainless steel and gold. The electrode surface can be porous, which can realize the saline perfusion function and prevent renal artery damage, scab or clot formation. At the same time, the lower contact surface temperature allows the catheter system to use higher power for ablation, increase the ablation depth, and remove the lesion more safely and effectively. The perfusion and temperature measurement functions can improve the safety and effectiveness of ablation to a certain extent. The adjustable curved catheters currently available on the market are assembled using a multi-section connection type. There are problems such as protrusions and weak connection strength at the connection. There are risks such as scratches, dissections, and shedding during the operation, which increases the difficulty of surgical operation. To this end, the present invention aims to achieve the integration of the adjustable curved catheter.

[0030] In order to make the purpose, advantages and features of the present invention clearer, the present invention is further described in detail below in conjunction with the accompanying drawings and specific embodiments. It should be noted that the drawings are all in a very simplified form and are not drawn to scale, and are only used to conveniently and clearly assist in explaining the purpose of the embodiments of the present invention. In addition, the structure shown in the drawings is often a part of the actual structure. In particular, the emphasis of each drawing is different, and sometimes different scales are used.

[0031] As used in the present invention, the singular forms "a", "an" and "the" include plural objects, the term "or" is generally used in a sense including "and / or", the term "several" is generally used in a sense including "at least one", and the term "at least two" is generally used in a sense including "two or more". In addition, the terms "first", "second" and "third" are used for descriptive purposes only and cannot be understood as indicating or suggesting relative importance or implicitly indicating the number of the indicated technical features. Thus, the features defined as "first", "second", and "third" may explicitly or implicitly include one or at least two of the features, "one end" and "the other end" and "the proximal end" and "the distal end" generally refer to two corresponding parts, which are not only included in the present application document, "proximal end" and "distal end" are the relative orientation, relative position, and direction of the elements or actions relative to each other from the perspective of the doctor using the medical device, although "proximal end" and "distal end" are not restrictive, but "proximal end" generally refers to the end of the medical device close to the doctor during normal operation, and "distal end" generally refers to the end that first enters the patient's body. In addition, as used in the present invention, "installed", "connected", "connected", and one element "set" on another element should be understood in a broad sense, usually only indicating that there is a connection, coupling, matching or transmission relationship between the two elements, and the connection, coupling, matching or transmission between the two elements can be direct or indirect through an intermediate element, and cannot be understood as indicating or implying the spatial position relationship between the two elements, that is, one element can be in any orientation such as inside, outside, above, below or on one side of another element, unless the content clearly indicates otherwise.

[0032] [Example 1]

[0033] See also Figure 1 Combined with Figure 2 The embodiment of the present invention provides an integrated adjustable bend catheter, comprising: an electrode segment 13, a bendable segment 12 and a main segment 11 connected in sequence from the distal end to the proximal end, wherein the bendable segment 12 and the main segment 11 are integrally formed and each comprises a polymer inner layer 100, a braided layer and a polymer outer layer 300 stacked in sequence from the inside to the outside, wherein Figure 2 As shown in , the braided layer of the bendable section 12 is a spiral braided structure 201, and the braided layer of the main section 11 is a mesh braided structure 202, such as a plain braided structure. The spiral braided structure of the bendable section 12 meets the bending control requirements of the bendable section 12, and the mesh braided structure 202 of the main section 11 provides a higher support force and torsion control capability for the catheter.

[0034] Optionally, when forming the bendable section 12 and the main section 11, the braided layer between the two can be connected by docking after the two braided structures are woven, or the braided layer between the two can be woven as one piece, and the weaving method is changed during the weaving process so that the braided layer between the two has different braided structures. The specific weaving method is not the focus of this application and will not be described in detail here. However, it should be understood that no matter what method is used to form the middle braided layer, the polymer inner layer 100 and the polymer outer layer 300 of the bendable section 12 and the main section 11 can be integrally formed by drawing or the like.

[0035] The catheter provided in the embodiment of the present invention adopts an integrated molding manufacturing method, which can reduce the development cost of raw materials, reduce the manufacturing process and the difficulty of assembly for workers. In addition, when the catheter enters a complex heart structure, a bifurcation or a special-shaped structure of a blood vessel, it ensures that the catheter moves smoothly without scratching the tissue, thereby improving the safety, effectiveness and ease of use of the catheter; the braided layer of the bendable section 12 adopts a spiral braided structure 201, which has good softness and resilience, and is easy to control the bending in place.

[0036] In the prior art, the bendable section 12 usually adopts a multi-lumen tube to achieve the purpose of bending control. However, the catheter provided in this embodiment adopts a spiral braided structure 201 to meet the bending control requirements of the bendable section 12 and has good recoverability. Therefore, the bendable section 12 in the embodiment of the present invention can abandon the multi-lumen structure of the bendable section 12 in the prior art and be a single-lumen tube section, thereby achieving the purpose of reducing the processing difficulty of the bendable section 12.

[0037] The catheter provided in an embodiment of the present invention may further include a handle (not shown), which is connected to the proximal end of the main body section 11. The distal end of a pull wire for controlling bending is connected to the bendable section 12, and the proximal end is connected to the handle. The handle controls the bending shape of the bendable section 12 by controlling the movement of the pull wire.

[0038] In this embodiment, the integrated adjustable curved catheter is a ring-shaped adjustable curved catheter, which can be used for monitoring pulmonary vein ECG signals, and can also be used for mapping other parts. It can be used alone or in conjunction with other ablation catheters, such as a balloon catheter, which can reach the heart through the inner channel of the balloon catheter to help the balloon catheter find the pulmonary vein and monitor the catheter ablation effect. The catheter can also be used for different ablation energy sources, such as radio frequency, pulse, microwave and other energies, which are not limited in this application.

[0039] For more details, please see Figure 1The electrode segment 13 of the annular adjustable curved catheter includes an annular support tube 131 and a first electrode 132 arranged on the annular support tube 131. The first electrode 132 can be made of metal materials such as gold, platinum-iridium alloy or stainless steel, and plays a mapping and / or ablation role. Specifically, it can be a ring electrode or a microelectrode. When the first electrode 132 is a ring electrode, it is sleeved on the annular support tube 131. Figure 2 As shown in the figure, the number of turns of the annular support tube 131 is approximately one turn. In some other embodiments, the number of turns of the annular support tube 131 may be multiple turns, which are spirally distributed and always have relative proximal and distal ends, wherein the proximal end is a connecting end for connecting to the distal end of the bendable section 12, and the distal end is a free end. Other deformation structures of the annular support tube are not described in detail in this application.

[0040] In order to increase the ablation area, preferably, the electrode segment 13 includes a plurality of first electrodes 132, and the plurality of first electrodes 132 are sequentially arranged along the extension direction of the annular support tube 131. Preferably, in addition to the bendable segment 12 and the main segment 11 being integrally formed, the annular support tube 131 can also be integrally formed with the bendable segment 12 and the main segment 11, and the braided layer of the annular support tube 131 is the spiral braided structure 201 that is the same as the braided layer of the bendable segment 12.

[0041] For the existing annular adjustable bend catheter, the annular support tube 131 of the electrode segment 13 usually uses a non-woven polymer hose, and a shaping wire is arranged inside the hose to achieve shape shaping and ring diameter fixing. The bendable segment 12 also mostly uses a non-woven hose, which on the one hand meets the bending control requirements, and on the other hand serves to connect the electrode segment 13 with the main segment 11. The annular adjustable bend catheter in this embodiment adopts an integrated molding technology. The annular support tube 131, the bendable segment 12 and the main segment 11 use an integrated molded pipe. The annular support tube 131 can achieve shaping and fix the ring diameter through a spiral braided wire, without the need to install an additional shaping wire. The spiral braided wire of the bendable segment 12 can meet the bending control requirements of the bendable segment 12, and has good resilience, which helps to improve the problem that the bendable segment 12 is deformed and cannot be restored after the existing catheter is bent. Compared with existing catheters, the integrated adjustable bend catheter provided in this embodiment eliminates the process of connecting the electrode segment 13 and the bendable segment 12, achieves one-piece molding without connection gaps, and avoids damage to tissues caused by the catheter during surgery.

[0042] The wire of the first electrode 132 needs to extend out of the proximal end of the catheter to connect with the radiofrequency instrument, three-dimensional system, etc. For the existing annular adjustable bend catheter, a through hole is generally opened on the annular support tube 131, and the electrode wire passes through the through hole into the catheter and extends out from the proximal end of the catheter. In this embodiment, the annular support tube 131 has a braided layer, and the braided layer is generally made of metal material. If a through hole is opened on the annular support tube 131, there will be a risk of wire breakage and catheter leakage. In view of this, preferably, the first electrode 132 extends from the distal end (i.e., the free end) of the annular support tube 131 into the annular support, and extends to pass through the inner cavity of the annular support tube 131, the bendable section 12 and the main section 11 in sequence, until it extends out of the proximal end of the main section 11. It is understandable that the free end of the annular support tube 131 can be sealed by a plugging piece, or by injecting glue, and the sealing operation can be performed after the wire of the first electrode 132 extends from the free end into the annular support. Through this lead-in method, the problems of wire breakage and catheter leakage caused by perforating the annular support tube 131 can be avoided. Furthermore, in order to make the wire of the first electrode 132 fit the outer surface of the annular support tube 131, a layer of heat shrink tube can be set on the annular support tube 131, or a layer of glue can be applied on the annular support.

[0043] In addition, preferably, the electrode segment 13 also includes a temperature sensor (not shown). The first electrode 132 is welded with a temperature sensor on one side close to the annular support tube 131. The temperature sensor is arranged in close contact with the first electrode 132 to monitor the actual temperature of human tissue. The temperature sensor can be a conventional thermocouple, and its metal wire is used to simultaneously serve as the conductor of the first electrode 132, so that the radio frequency instrument end can simultaneously release energy and monitor temperature. When the metal wire of the temperature sensor serves as the conductor of the first electrode 132, similarly, in order to avoid the problem of wire damage and catheter leakage caused by punching, the metal wire of the temperature sensor extends from the free end of the annular support tube 131 into the annular support tube 131, and extends to pass through the inner cavity of the annular support tube 131, the bendable segment 12 and the main body segment 11 in sequence, until it extends out of the proximal end of the main body segment 11.

[0044] [Example 2]

[0045] See also Figure 3In this embodiment, the integrated adjustable bend conduit is a straight conduit. Specifically, the electrode segment 13 includes a straight support tube 140 and a second electrode 141 axially connected to the distal end of the straight support tube 140. The proximal end of the straight support tube 140 and the distal end of the bendable segment 12 are connected by fusion welding to achieve a smooth transition. It can be understood that the second electrode 141 is a head electrode. If the head electrode is directly connected to the bendable segment 12, poor insulation may result. Therefore, after the second electrode 141 is connected to the distal end of the straight support tube 140 made of insulating material, it is connected to the bendable segment 12 through the straight support tube 140. Preferably, the second electrode 141 is bonded to the distal end of the straight support tube 140, and the gap between the second electrode 141 and the straight support tube 140 is filled with glue.

[0046] In existing linear adjustable bend catheters, the sections are generally connected by gluing or other methods. The connection of multiple sections leads to gaps, pits, protrusions and other problems on the catheter surface, which reduces the safety of use during surgery. In the linear adjustable bend catheter provided in this embodiment, on the one hand, the bendable section 12 and the main section 11 are integrally formed with a smooth surface. On the other hand, the electrode section 13 and the bendable section 12 are melt-welded by high-frequency welding. This welding process can achieve a smooth transition between the electrode section 13 and the bendable section 12. In addition, the gap between the second electrode 141 of the electrode section 13 and the straight support tube 140 is filled with glue. Therefore, the overall surface of the catheter is smooth and the movement fluency is improved.

[0047] In addition, the electrode segment 13 may also include a third electrode 142, which is disposed on the straight support tube 140. The third electrode 142 may be an ablation electrode, which may be in the form of a ring electrode or a microelectrode, and the ablation electrode contacts the blood vessel wall or tissue, and energy may be applied for ablation. However, the present application does not limit the third electrode 142 to only being an ablation electrode, and may also be configured as other electrodes, such as a mapping electrode. The third electrode 142 is also configured as a mapping electrode and / or an ablation electrode.

[0048] [Example 3]

[0049] In this embodiment, the integrated adjustable curved conduit is another linear adjustable curved conduit, which is different from the second embodiment. Figure 4 In this embodiment, the integrated adjustable bending conduit has two pull-wire systems, which can control the bendable section 12 to have two bending shapes.

[0050] For an adjustable bend catheter, when a multi-lumen tube is used for the bendable section, the addition of a pull-wire system makes it more difficult to assemble in the originally tight space. The integrated adjustable bend catheter provided in this embodiment abandons the multi-lumen tube and uses a single-lumen tube, so that the functional systems are no longer constrained by the diameter of the multi-lumen tube when being assembled.

[0051] In summary, the integrated adjustable bend catheter provided by the present invention comprises: an electrode segment, a bendable segment and a main body segment connected in sequence from the distal end to the proximal end, the bendable segment and the main body segment are integrally formed, and both comprise a polymer inner layer, a braided layer and a polymer outer layer stacked in sequence from the inside to the outside, wherein the braided layer of the bendable segment is a structure, and the braided layer of the main body segment is a mesh braided structure. The integrated adjustable bend catheter provided by the present invention adopts an integrated molding manufacturing method, which can reduce the development cost of raw materials, reduce the manufacturing process and the assembly difficulty of workers. In addition, when the catheter enters a complex heart structure, a bifurcation or a special-shaped structure of a blood vessel, it ensures that the catheter moves smoothly without scratching the tissue, thereby improving the safety, effectiveness and ease of use of the catheter; the braided layer of the bendable segment adopts a spiral braided structure, which has good softness and resilience, and is easy to control the bend in place.

[0052] It should be noted that the various embodiments in this specification are described in a progressive manner, and each embodiment focuses on the differences from other embodiments. The same or similar parts between the various embodiments can be referenced to each other. In addition, the different parts between the various embodiments can also be used in combination with each other, and the present invention is not limited to this.

[0053] In addition, it should be recognized that although the present invention has been disclosed as a preferred embodiment, the above embodiment is not intended to limit the present invention. For any technician familiar with the art, without departing from the scope of the technical solution of the present invention, the technical content disclosed above can be used to make many possible changes and modifications to the technical solution of the present invention, or modified into equivalent embodiments of equivalent changes. Therefore, any simple modification, equivalent change and modification made to the above embodiment according to the technical essence of the present invention without departing from the content of the technical solution of the present invention still belongs to the scope of protection of the technical solution of the present invention.

Claims

1. An integrated adjustable curved conduit, characterized in that: include: The electrode segment, the bendable segment and the main body segment are connected in sequence from the distal end to the proximal end, the bendable segment and the main body segment are integrally formed, and both include a polymer inner layer, a braided layer and a polymer outer layer stacked in sequence from the inside to the outside, wherein the braided layer of the bendable segment is a spiral braided structure, and the braided layer of the main body segment is a mesh braided structure.

2. The integrated adjustable curved conduit as claimed in claim 1, characterized in that: The electrode segment includes a support tube and an electrode arranged on the support tube; The support tube is melt-welded to the distal end of the bendable section; or, the support tube, the bendable section and the main section are integrally formed, and the wire of the electrode extends from the distal end of the support tube into the support tube, and extends to pass through the inner cavity of the support tube, the bendable section and the main section in sequence, until it extends out of the proximal end of the main section.

3. The integrated adjustable curved conduit as claimed in claim 2, characterized in that: The support tube is an annular support tube, and the annular support tube, the bendable section and the main body section are integrally formed, and the braided layer of the annular support tube has the same spiral braided structure as the braided layer of the bendable section.

4. The integrated adjustable curved conduit as claimed in claim 3, characterized in that: The electrode is a first electrode, the electrode segment includes a plurality of the first electrodes, and the plurality of the first electrodes are sequentially arranged along the extending direction of the annular support tube.

5. The integrated adjustable curved conduit as claimed in claim 4, characterized in that: The electrode segment further includes a temperature sensor. The temperature sensor is welded to a side of the first electrode close to the annular support tube. The metal wire of the temperature sensor is used to simultaneously serve as a conductor of the first electrode.

6. The integrated adjustable curved conduit as claimed in claim 2, characterized in that: The support tube is a straight support tube, the proximal end of the straight support tube and the distal end of the bendable section are connected by fusion welding to achieve a smooth transition, and the electrode includes a second electrode connected to the distal end of the straight support tube.

7. The integrated adjustable curved conduit as claimed in claim 6, characterized in that: The second electrode is bonded to the distal end of the straight support tube, and a gap between the second electrode and the straight support tube is filled with glue.

8. The integrated adjustable curved conduit as claimed in claim 6, characterized in that: The electrode further comprises a third electrode arranged on the straight support tube.

9. The integrated adjustable curved conduit as claimed in claim 1, characterized in that: The bendable section is a single-lumen tube section.

10. The integrated adjustable curved conduit as claimed in claim 1, characterized in that: The integrated adjustable bendable catheter also includes a handle and at least one pull wire, the handle is connected to the proximal end of the main body section, the proximal end of the pull wire is fixed to the handle, and the distal end of the pull wire is fixed to the bendable section. The handle drives the pull wire to move to control the bending of the bendable section.

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