Bending-adjustable mesh basket ablation catheter and preparation method thereof

Abstract

The invention discloses an adjustable bent mesh basket ablation catheter and a preparation method thereof. The catheter comprises a mesh basket assembly, a sleeve, a front push-pull ring, a side push-pull button, a handle, an irrigation element, a far-end tube, an elbow adjusting tube, a near-end tube, a head end fixing piece, a middle electrode ring, a magnetoelectric positioning sensor, a pull ring, a pull wire, a magnetoelectric positioning sensor wire, a wire, an end electrode ring and an insulating sleeve. The ablation catheter has the advantages that the front end of the ablation catheter is of the mesh basket structure, the mesh basket structure can be flexibly unfolded or contracted, two different diameters can be switched at any time, electrodes on the ablation catheter are well attached to tissue, stability is high, the ablation catheter can be suitable for different pulmonary vein opening anatomical structures, the contact area of the mesh basket assembly and the tissue is increased after the ablation catheter is unfolded, and the ablation effect is good. Therefore, the time required by ablation is shortened, the irrigation structure in the catheter is beneficial to reducing tissue damage and reducing thrombus occurrence, the catheter also has mapping, navigation and treatment functions, the time of instrument replacement is shortened, and the treatment effect is improved.

Description

TECHNICAL FIELD

[0001] The present application belongs to the technical field of medical devices, and particularly relates to an adjustable bending net basket ablation catheter and a preparation method thereof. BACKGROUND

[0002] In medicine, a pulse ablation instrument is a medical device that causes target cells to undergo programmed death by emitting an output high-voltage pulse signal, and is currently widely used in the field of atrial fibrillation treatment. An ablation catheter is a catheter used for pulse ablation surgery, which is usually used with a pulse ablation instrument. It can cause irreversible injury (IRE) of nanoscale electroporation of cell membranes through high-voltage pulse electric fields for a short time, and is commonly used to treat drug-refractory, recurrent, and symptomatic paroxysmal atrial fibrillation. By ablating abnormal myocardial cells, the normal rhythm of the heart is restored.

[0003] A medical catheter is disclosed in Chinese Patent Application No. 202110726356.3; its advantages are that the ring electrodes do not overlap each other, so that the electrical signal can be stably collected; and the mapping accuracy is high, which can meet the mapping of different pulmonary vein structures. However, the disadvantages are that the ring catheter has a small mapping range and a limited field of view, which easily misses key lesions, and the physician needs to withdraw the mapping catheter and insert an ablation catheter / point ablation catheter after completing the mapping, which increases the ablation surgery time and patient cost.

[0004] An ablation catheter is disclosed in Chinese Patent Application No. 201510870613.5; its advantages are that radiofrequency ablation evaporates water in the target tissue through thermal efficiency, thereby drying and necrosing the tissue to achieve the treatment purpose. The ablation catheter can accurately measure the contact pressure of the ablation catheter and the inner wall of the heart to avoid heart perforation caused by excessive pressure. However, the disadvantages are that the traditional ablation time is long, the ablation efficiency is low, the selectivity to the tissue is low, and the electrophysiological surgery such as pulmonary vein isolation cannot be efficiently performed. SUMMARY

[0005] To solve the above problems, the purpose of the present application is to provide an adjustable bending net basket ablation catheter and a preparation method thereof.

[0006] To achieve the above objectives, the adjustable basket ablation catheter provided by the present invention includes a basket assembly, a sleeve, a front push-pull ring, a side push-pull knob, a handle, an irrigation element, a distal tube, an adjustable tube, a proximal tube, a head fixing component, a middle electrode ring, a magnetoelectric positioning sensor, a pull ring, a pull wire, a magnetoelectric positioning sensor wire, a wire, an end electrode ring, and an insulating sleeve; wherein, the basket assembly is a bulb-shaped structure formed by multiple skeleton arms, each skeleton arm is provided with an insulating sleeve, and each insulating sleeve is provided with at least two spaced-apart end electrode rings; the distal tube, the adjustable tube, and the proximal tube are arranged in a head-to-tail configuration. The tail-to-tail connection is arranged inside the sleeve from front to back, with gaps between the distal tube, the bending tube, the proximal tube, and the sleeve. The front end of the head-end fixing member has multiple micro-perforated structures, located outside the front port of the distal tube. The middle part is annular and fixed at the front port of the distal tube, while the rear part is tubular and inserted inside the distal tube. Two middle electrode rings are fixed at intervals to the outside of the distal tube, and two other middle electrode rings are fixed at intervals to the outside of the bending tube. The rear end contraction opening of the basket assembly is arranged around the front end of the distal tube and axially fixed to the circumferential wall of the middle part of the head-end fixing member. A magnetoelectric positioning sensor is also present. The pull ring is located inside the distal tube; the front push-pull ring is fitted onto the outside of the proximal tube and connected to the rear end of the sleeve; the handle is a hollow structure, with the rear end of the proximal tube passing through the central hole of the front push-pull ring and connecting to the front port of the handle; a socket for the pulse ablation device is provided on the rear end face of the handle; the side push-pull knob is installed on the side of the handle; one end of the pull cable is fixed to the pull ring, and the middle section passes through the bending tube, the middle of the proximal tube, and the inside of the handle in sequence along the axial direction, with the other end connected to the side push-pull knob; one end of the magnetoelectric positioning sensor wire is connected to the magnetoelectric positioning sensor, and the middle section passes through the... The middle of the bend-adjusting tube, the proximal tube, and the inside of the handle are connected at the other end to the socket. One end of each wire is connected to an end electrode ring or a middle electrode ring. The middle of all wires passes through the middle of the distal tube, the bend-adjusting tube, the proximal tube, and the inside of the handle in sequence along the axial direction, or through the middle of the bend-adjusting tube, the proximal tube, and the inside of the handle. The other end is connected to the socket. The inlet of the irrigation element is connected to a saline container. The outer end of the extension tube passes through the rear end face of the handle and is fixed at the liquid cavity inside the proximal tube and the gap between the proximal tube and the sleeve. The outer side of the extension tube is fixed to the side of the handle.

[0007] The basket assembly is made of flexible materials, including nickel-titanium alloy, and has shape memory function. It is spherical or gourd-shaped and can change diameter under the action of the sleeve and the front push-pull ring. The end electrode rings on adjacent skeleton arms are arranged in an up-down or staggered manner.

[0008] The casing is a double-layer composite pipe, with the outer layer made of at least one material selected from polyether block polyamide and polyurethane; and the inner layer made of PTFE.

[0009] The distal tube is a three-layer composite tube, the outer tube is made of at least one of polyamide and polyether block polyamide; the middle tube is made of 304 stainless steel wire knitting; and the inner tube is made of at least one of polyamide and polyether block polyamide.

[0010] The bending-adjustable tube is a three-layer composite tube, the outer tube is made of at least one of polyether block polyamide and thermoplastic polyurethane elastomer; the middle tube is made of 304 stainless steel wire knitting; and the inner tube is a four-cavity tube and is made of at least one of polyamide, polyether block polyamide and thermoplastic polyurethane elastomer.

[0011] The proximal tube is a three-layer composite tube, the outer tube is made of at least one of polyamide, polyether block polyamide and thermoplastic polyurethane elastomer; the middle tube is made of 304 stainless steel wire knitting; and the inner tube is a PTFE tube.

[0012] The irrigation element is made of at least one of medical-grade PVC, silicone and thermoplastic polyurethane elastomer, and the outer end of the extension pipeline is fixed at the rear port of the gap between the proximal tube and the sleeve after passing through the rear end face of the handle 5.

[0013] The pull ring and the pull wire are made of stainless steel; the head-end fixing member, the middle electrode ring and the end electrode ring are made of platinum-iridium alloy and gold and other biocompatible inert materials; and the insulating sleeve is made of at least one of polyether block polyamide and thermoplastic polyurethane elastomer.

[0014] The preparation method of the adjustable bending basket ablation catheter provided by the application comprises the following steps in sequence:

[0015] 1) Preparation of the proximal tube: first, the inner tube is sleeved on a heat-shrinkable mandrel; then the heat-shrinkable mandrel and the inner tube are placed on a knitting machine together; the knitting machine is started to form the middle tube knitted by 304 stainless steel wire on the inner tube; then the outer tube and the heat-shrinkable tube are sleeved on the middle tube in sequence, and after assembly, they are placed on a laminating heat-shrinking machine together for heat shrinking; after completion, the heat-shrinkable tube is peeled off, and finally the heat-shrinkable mandrel is extracted to form the proximal tube.

[0016] 2) Preparation of distal tube and bending tube: first, four mandrels are placed in the four inner cavities of the bending tube, and then hollow mandrel sleeves are placed outside the four mandrels; the inner layer tube of the distal tube is sleeved on the hollow mandrel, one end of which overlaps with the inner layer tube of the bending tube having four cavities, and a heat shrink tube is sleeved outside it, and the inner layer tube of the distal tube and the inner layer tube of the bending tube are integrated by a hot air welding machine; then a middle layer tube woven by 304 stainless steel wire is formed on the inner layer tube by using a braiding machine; finally, the outer tube layer of the bending tube and the distal tube, and the heat shrink tube are sequentially sleeved on the corresponding middle layer tube, and are heat shrunk by a laminating heat shrink machine, after which the heat shrink tube is peeled off, and finally all the mandrels and hollow mandrel sleeves are extracted to form the distal tube and the bending tube;

[0017] 3) Connection of the basket assembly: the rear end of the basket assembly with the installed insulating sleeve and the end electrode ring is inserted into the circumferential wall of the head end fixing member at the front end of the distal tube, and then the basket assembly and the head end fixing member are fixed by glue;

[0018] 4) Connection of the pull wire and the lead wire: one end of the pull wire is fixed to the pull ring;

[0019] 5) Assembly of the internal structure of the distal tube and the bending tube assembly: the lead wire of the middle rear part of the head end fixing member, the magnetoelectric positioning sensor, the pull ring, and the end electrode ring is inserted into the cavity of the distal tube, and then the lead wire is led out of the outside of the bending tube; finally, the distal tube is filled with glue, the corresponding positions are adjusted, and the glue is cured to complete the assembly;

[0020] 6) The lead wire of the end electrode ring, the middle electrode ring, and the magnetoelectric positioning sensor is sequentially inserted into the inside of the proximal tube and the handle, and is placed in the front end of the proximal tube at the rear end of the distal tube and the bending tube assembly, and epoxy glue is applied at the gap and the connection surface of the pipe, and then it is placed in an oven for curing, thereby connecting into an integrated pipe;

[0021] 7) Assembly of the sleeve: the integrated pipe formed by the above-mentioned distal tube, bending tube, and proximal tube is inserted into the sleeve;

[0022] 8) Assembly of the handle and the front push-pull ring: the rear end of the sleeve and the proximal tube are connected with the front push-pull ring and the front end of the handle, respectively;

[0023] 9) The proximal tube is fixed in the inside of the handle, and the other end of the pull wire is connected to the side push-pull ring;

[0024] 10) Assembly of the irrigation element: the outer end of the extension pipe is fixed in the liquid cavity of the proximal tube and the gap between the proximal tube and the sleeve after passing through the rear end surface of the handle, and the outside of the extension pipe is fixed on the side surface of the handle;

[0025] 11) Finally, the other end of the wire of the magnetic-electric positioning sensor, the middle electrode ring and the end electrode ring are electrically connected with the socket, thus completing the whole preparation process.

[0026] The adjustable bending net basket ablation catheter and the preparation method thereof have the following beneficial effects: the front end of the ablation catheter is a net basket structure, the structure can be flexibly expanded or contracted, and the two different diameters can be switched at any time, the electrodes on the structure have good tissue adhesion and high stability, the structure can be applied to different pulmonary vein orifice anatomical structures, the contact area between the net basket assembly and the tissue is increased after expansion, so that the ablation time is reduced, the irrigation structure in the catheter helps to reduce tissue damage and reduce thrombosis, the catheter also has the functions of mapping, navigation and treatment, the time of replacing the instrument is shortened, and the treatment effect is improved. BRIEF DESCRIPTION OF DRAWINGS

[0027] Figure 1 The adjustable bending net basket ablation catheter provided by the present application is shown in the figure.

[0028] Figure 2 A is a structure schematic view of the net basket assembly in the adjustable bending net basket ablation catheter provided by the present application.

[0029] Figure 2 B is a structure schematic view of the net basket assembly in the adjustable bending net basket ablation catheter provided by the present application.

[0030] Figure 3 The adjustable bending net basket ablation catheter provided by the present application is shown in the figure.

[0031] Figure 4 The longitudinal structure of the catheter is shown in the cross-sectional view.

[0032] Figure 5 The cross-sectional view of the bending pipe and the proximal pipe is shown in the figure.

[0033] Figure 6 A and Figure 6 B are respectively the front view and the perspective view of the net basket assembly in the adjustable bending net basket ablation catheter provided by the present application.

[0034] Figure 7 A and Figure 7 B are respectively the front view and the perspective view of the net basket assembly in the embodiment 1.

[0035] Figure 8 A and Figure 8 B are respectively the front view and the perspective view of the net basket assembly in the embodiment 2.

[0036] Figure 9 A and Figure 8 B are respectively the front view and the perspective view of the net basket assembly in the embodiment 3.

[0037] Figure 10 A and Figure 10 B are front and perspective views, respectively, of the basket assembly of Example 4.

[0038] Figure 11 A and Figure 11 B are front and perspective views, respectively, of the basket assembly of Example 5. DETAILED DESCRIPTION

[0039] The application will be described in greater detail with reference to the accompanying drawings and specific examples.

[0040] As Figures 1-6 A, Figure 6As shown in B, the adjustable bending basket ablation catheter provided by the application is matched with a pulse ablation instrument, and comprises a basket assembly 1, a sleeve 2, a front push-pull ring 3, a side push-pull knob 4, a handle 5, an irrigation element 6, a distal tube 7, a bending tube 8, a proximal tube 9, a head end fixing part 10, middle electrode rings 11, a magneto-electric positioning sensor 12, a pull ring 13, a pull wire 14, a magneto-electric positioning sensor wire 15, wires 17, end electrode rings 19 and insulating sleeves 20. The basket assembly 1 is a bulb-shaped structure surrounded by a plurality of framework arms 18, and each framework arm 18 is externally provided with an insulating sleeve 20, and each insulating sleeve 20 is provided with at least two end electrode rings 19 arranged at intervals to realize target position mapping and ablation. The distal tube 7, the bending tube 8 and the proximal tube 9 are arranged in the inside of the sleeve 2 in a head-to-tail manner from front to back, and there is a space between the distal tube 7, the bending tube 8, the proximal tube 9 and the sleeve 2 to facilitate the deformation of the bending tube 8 and to serve as a physiological saline flow channel to prevent thrombosis and blood reflux. The front end of the head end fixing part 10 is formed with a plurality of microporous structures, is located outside the front end port of the distal tube 7, is annular in the middle and is fixed at the front end port of the distal tube 7, is tubular in the back and is inserted into the inside of the distal tube 7 to serve as a physiological saline flow channel to realize uniform flushing and prevent high pressure from damaging human tissues. Two middle electrode rings 11 are fixed at intervals outside the distal tube 7, and the other two middle electrode rings 11 are fixed at intervals outside the bending tube 8. The rear end contraction opening of the basket assembly 1 is arranged around the circumferential wall outside the front end of the distal tube 7 and is fixed in the middle of the head end fixing part 10 in the axial direction. The magneto-electric positioning sensor 12 and the pull ring 13 are arranged in the inside of the distal tube 7, wherein the magneto-electric positioning sensor 12 is used to obtain the absolute position coordinates of the two middle electrode rings 11 on the distal tube 7. The front push-pull ring 3 is sleeved outside the proximal tube 9 and is connected with the rear end of the sleeve 2 to push the sleeve 2 to change the diameter of the basket assembly 1. The handle 5 is a hollow structure, the rear end of the proximal tube 9 is connected with the front end port of the handle 5 after passing through the center hole of the front push-pull ring 3, and the rear end surface of the handle 5 is provided with a socket matched with the pulse ablation instrument. The side push-pull knob 4 is installed on the side surface of the handle 5. One end of the pull wire 14 is fixed on the pull ring 13, the middle part penetrates the middle part of the bending tube 8, the proximal tube 9 and the inside of the handle 5 in sequence in the axial direction, and the other end is connected with the side push-pull knob 4. One end of the magneto-electric positioning sensor wire 15 is connected with the magneto-electric positioning sensor 12, the middle part penetrates the middle part of the bending tube 8, the proximal tube 9 and the inside of the handle 5 in sequence in the axial direction, and the other end is electrically connected with the socket. One end of each wire 17 is connected with an end electrode ring 19 or a middle electrode ring 11, the middle part of all the wires penetrates the middle part of the distal tube 7, the bending tube 8, the proximal tube 9 and the inside of the handle 5 or the middle part of the bending tube 8, the proximal tube 9 and the inside of the handle 5 in sequence in the axial direction, and the other end is electrically connected with the socket.The irrigation element 6 is connected to a physiological saline solution container, and the outer end of the extension pipeline is fixed in the liquid cavity 16 of the proximal tube 9 and the gap between the proximal tube 9 and the sleeve 2 after penetrating the rear end face of the handle 5, and the outer side of the extension pipeline is fixed on the side of the handle 5, which is used for flushing the human tissue to prevent thrombosis.

[0041] The basket assembly 1 is made of a flexible material with shape memory function, such as nickel-titanium alloy, and has a spherical or gourd shape and can change in diameter under the action of the sleeve 2 and the front push-pull ring 3; the end electrode rings 19 on the adjacent frame arms 18 are arranged in an up-down or staggered manner. Figure 6 A, 6B, the basket assembly 1 is composed of 8 frame arms 18; each frame arm 18 is provided with two end electrode rings 19 with a spacing of 2mm, and the end electrode rings 19 on the adjacent frame arms 18 are arranged in an up-down manner.

[0042] The sleeve 2 is a double-layer composite tube, and the outer tube is made of at least one of polyether block polyamide (Pebax) and polyurethane (PU); the inner tube is a PTFE tube.

[0043] The distal tube 7 is a three-layer composite tube, the outer tube is made of at least one of polyamide (PA) and polyether block polyamide; the middle tube is woven by 304 stainless steel wire; and the inner tube is made of at least one of polyamide and polyether block polyamide.

[0044] The bending tube 8 is a three-layer composite tube, the outer tube is made of at least one of polyether block polyamide and thermoplastic polyurethane elastomer to provide different flexural properties to achieve uniform deformation of the bending tube 8; the middle tube is woven by 304 stainless steel wire; and the inner tube is a four-cavity tube made of at least one of polyamide, polyether block polyamide and thermoplastic polyurethane elastomer; one cavity is used for penetrating the pull wire 14, one cavity is used for penetrating the magnetoelectric positioning sensor wire 15 and the electrode ring wire 17, another cavity is the liquid cavity 16, and the remaining cavity is used for setting the standby pull wire 14.

[0045] The proximal tube 9 is a three-layer composite tube, the outer tube is made of at least one of polyamide (PA), polyether block polyamide (Pebax) and thermoplastic polyurethane elastomer (TPU); the middle tube is woven by 304 stainless steel wire; and the inner tube is a PTFE tube used for penetrating the magnetoelectric positioning sensor wire 15, the electrode ring wire 17 and the pull wire 14 and as a liquid flow channel.

[0046] The irrigation element 6 is made of at least one of medical-grade PVC, silicone, and thermoplastic polyurethane elastomer, and the outer end of the extension pipeline is fixed in the proximal tube 9 after passing through the rear end face of the handle 5 and the gap between the proximal tube 9 and the sleeve 2.

[0047] The pull ring 13 and the pull wire 14 are made of stainless steel; the head-end fixing member 10, the middle electrode ring 11, and the end electrode ring 19 are made of biocompatible inert materials such as platinum-iridium alloy and gold; and the insulating sleeve 20 is made of at least one of polyether block polyamide and thermoplastic polyurethane elastomer.

[0048] The preparation method of the adjustable curved mesh basket ablation catheter includes the following steps in sequence:

[0049] 1) Preparation of the proximal tube 9: first, the inner tube is sleeved on the heat-shrinkable mandrel; then the heat-shrinkable mandrel and the inner tube are placed on the braiding machine; the braiding machine is started to form the middle tube woven by 304 stainless steel wires on the inner tube; then the outer tube and the heat-shrinkable tube are sequentially sleeved on the middle tube; after assembly, they are placed together in the laminating heat-shrinking machine for heat shrinking; after completion, the heat-shrinkable tube is peeled off; finally, the heat-shrinkable mandrel is extracted to form the proximal tube 9.

[0050] 2) Preparation of the distal tube 7 and the bending tube 8: first, four mandrels are respectively placed at the four inner cavities of the bending tube 8, and then the hollow mandrel is sleeved outside the four mandrels; the inner tube of the distal tube 7 is sleeved on the hollow mandrel, with one end overlapping the inner tube of the bending tube 8 having four cavities, and the heat-shrinkable tube is sleeved outside; the inner tube of the bending tube 8 and the inner tube of the distal tube 7 are integrated into a structure by a hot air welding machine; then the braiding machine is used to form the middle tube woven by 304 stainless steel wires on the inner tube; finally, the outer tube layer and the heat-shrinkable tube of the bending tube 8 and the distal tube 7 are sequentially sleeved on the corresponding middle tube, and heat shrinking is performed by the laminating heat-shrinking machine; after completion, the heat-shrinkable tube is peeled off; finally, all the mandrels and the hollow mandrel are extracted to form the distal tube 7 and the bending tube 8.

[0051] 3) Connection of the mesh basket assembly 1: the rear end of the mesh basket assembly 1 with the installed insulating sleeve 20 and the end electrode ring 19 is inserted into the circumferential wall of the head-end fixing member 10 in the axial direction and is arranged on the outer side of the front end of the distal tube 7; then the mesh basket assembly 1 and the head-end fixing member 10 are fixed by glue.

[0052] 4) Connection of the pull wire 14 and the guide wire 17: one end of the pull wire 14 is fixed on the pull ring 13.

[0053] 5) Assembling of the inner structure of the pipe assembled by the distal tube 7 and the bending tube 8: the middle and rear part of the head end fixing part 10, the lead wire 17 of the magneto-electric positioning sensor 12, the pull ring 13 and the end electrode ring 19 are put into the cavity of the distal tube 7, and then the lead wire is led out of the outside of the bending tube 8; finally, the glue is poured into the distal tube 7 and the corresponding position is adjusted, and the assembly is completed after solidification;

[0054] 6) The end electrode ring 19, the middle electrode ring 11 and the lead wire 17 of the magneto-electric positioning sensor 12 are sequentially penetrated into the inside of the proximal tube 9 and the handle 5, and then placed into the front end of the proximal tube 9 at the rear end of the pipe assembled by the distal tube 7 and the bending tube 8, and the epoxy glue is applied at the gap and the connecting surface of the pipe, and then placed in the oven for solidification, thereby connected into an integrated pipe;

[0055] 7) Assembly of the sleeve 2: the integrated pipe assembled by the distal tube 7, the bending tube 8 and the proximal tube 9 is put into the sleeve 2;

[0056] 8) Assembly of the handle 5 and the front push-pull ring 3: the rear end of the sleeve 2 and the proximal tube 9 are connected with the front end of the handle 5 and the front push-pull ring 3 respectively;

[0057] 9) The proximal tube 9 is fixed in the inside of the handle 5, and the other end of the pull wire 14 is connected to the side push-pull ring 4;

[0058] 10) Assembly of the irrigation element 6: the outer end of the extended pipe is fixed in the liquid cavity 16 of the proximal tube 9 and the gap between the proximal tube 9 and the sleeve 2 after passing through the rear end surface of the handle 5, and the outside of the extended pipe is fixed on the side surface of the handle 5;

[0059] 11) Finally, the other end of the lead wire 17 of the end electrode ring 19, the middle electrode ring 11 and the magneto-electric positioning sensor 12 is electrically connected with the socket, thereby completing the whole preparation process.

[0060] The use method of the adjustable bending net basket ablation catheter provided by the present application is described as follows: when it is needed to perform pulse ablation operation on a patient by using a pulse ablation instrument and the adjustable bending net basket ablation catheter, first, the medical staff connects the socket on the adjustable bending net basket ablation catheter with the electrical interface on the pulse ablation instrument; then, the adjustable bending net basket ablation catheter is put into the human body, and in the process of operation, the target position is measured and discharged by using the end electrode ring 19, and the absolute position coordinates of the two middle electrode rings 11 on the distal tube 7 are obtained by using the magneto-electric positioning sensor 12; at the same time, the physiological saline is provided to the human tissue through the gap between the head end fixing part 10, the distal tube 7, the bending tube 8 and the proximal tube 9 and the sleeve 2 by using the irrigation element 6, so as to prevent thrombosis and blood reflux. When it is needed to change the diameter of the net basket assembly 1 according to the ablation position of the patient, one hand holds the handle 5, and the other hand pushes the front push-pull ring 3 forward, so as to make the net basket assembly 1 enter the sleeve 2 from the front end of the sleeve 2 and change the diameter of the net basket assembly 1, or pull the front push-pull ring 3 backward, so as to make the net basket assembly 1 expose outside the front end of the sleeve 2, and then the shape memory function of the used material is used to restore the original large diameter. For example, Figure 2 A, 2B, the two diameters are 30 mm and 12 mm respectively. When it is needed to change the angle of the net basket assembly 1, the side push-pull ring 4 is pushed backward, the distal tube 7 is pulled backward through the pull wire 14 and the pull ring 13, so as to make the relatively soft bending tube 8 produce bending deformation, thereby changing the angle of the net basket assembly 1, and vice versa.

[0061] Example 1:

[0062] For example, Figure 7 A, 7B, the net basket assembly 1 is spherical and is composed of eight framework arms 18, and each framework arm 18 is provided with an insulating sleeve 20, which is made of Pebax, TPU or other materials. Two end electrode rings 19 are arranged on each framework arm 18, the interval between the two end electrode rings 19 is 3 mm, and the end electrode rings 19 on the adjacent framework arms 18 are arranged in an up-down manner.

[0063] Example 2:

[0064] For example, Figure 8 A, 8B, the net basket assembly 1 is spherical and is composed of eight framework arms 18, and each framework arm 18 is provided with an insulating sleeve 20, which is made of Pebax, TPU or other materials. Two end electrode rings 19 are arranged on each framework arm 18, the interval between the two end electrode rings 19 is 3 mm, and the end electrode rings 19 on the adjacent framework arms 18 are arranged in an up-down manner.

[0065] Example 3:

[0066] As shown in Figure 9 The basket assembly 1 is spherical, as shown in A, 9B, which is composed of 8 skeleton arms 18, and each skeleton arm 18 is provided with an insulating sleeve 20, which is made of polyether block polyamide (Pebax), thermoplastic polyurethane elastomer (TPU) and other materials. Each skeleton arm 18 is provided with three end electrode rings 19, with a spacing of 2mm, and the end electrode rings 19 on adjacent skeleton arms 18 are arranged in an up-down manner.

[0067] Example 4:

[0068] As shown in Figure 10 The basket assembly 1 is spherical, as shown in A, 9B, which is composed of 8 skeleton arms 18, and each skeleton arm 18 is provided with an insulating sleeve 20, which is made of polyether block polyamide (Pebax), thermoplastic polyurethane elastomer (TPU) and other materials. Each skeleton arm 18 is provided with three end electrode rings 19, with a spacing of 2mm, and the end electrode rings 19 on adjacent skeleton arms 18 are arranged in an up-down manner.

[0069] Example 5:

[0070] As shown in Figure 11 The basket assembly 1 is spherical, as shown in A, 9B, which is composed of 8 skeleton arms 18, and each skeleton arm 18 is provided with an insulating sleeve 20, which is made of polyether block polyamide (Pebax), thermoplastic polyurethane elastomer (TPU) and other materials. Each skeleton arm 18 is provided with three end electrode rings 19, with a spacing of 2mm, and the end electrode rings 19 on adjacent skeleton arms 18 are arranged in an up-down manner.

Claims

1. An adjustable-bend basket ablation catheter, used in conjunction with a pulse ablation device, characterized in that: The adjustable-bend basket ablation catheter includes a basket assembly (1), a sleeve (2), a front push-pull ring (3), a side push-pull knob (4), a handle (5), an irrigation element (6), a distal tube (7), an adjustable tube (8), a proximal tube (9), a head end fixing piece (10), a middle electrode ring (11), a magnetoelectric positioning sensor (12), a pull ring (13), a pull wire (14), a magnetoelectric positioning sensor wire (15), a wire (17), an end electrode ring (19), and an insulating sleeve (20); wherein, the basket assembly (1) is a bulb-shaped structure formed by multiple skeleton arms (18), each skeleton arm (18) is provided with an insulating sleeve (20) on its exterior, and each insulating sleeve (20) is provided with one to one Two end electrode rings (19) are spaced apart; the distal tube (7), the bending tube (8), and the proximal tube (9) are arranged end-to-end inside the sleeve (2), with gaps between the distal tube (7), the bending tube (8), the proximal tube (9), and the sleeve (2); the front end of the head fixing member (10) has multiple micro-hole structures, located outside the front port of the distal tube (7), the middle part is annular and fixed at the front port of the distal tube (7), and the rear part is tubular and inserted into the interior of the distal tube (7); two middle electrode rings (11) are spaced apart and fixed outside the distal tube (7), and two other middle electrode rings (11) are spaced apart and fixed outside the bending tube (8); the rear end of the basket assembly (1) The contraction port is set around the front end of the distal tube (7) and fixed axially to the circumferential wall of the head end fixing part (10); the magnetoelectric positioning sensor (12) and the pull ring (13) are set inside the distal tube (7); the front push-pull ring (3) is sleeved on the outside of the proximal tube (9) and connected to the rear end of the sleeve (2); the handle (5) is a hollow structure, and the rear end of the proximal tube (9) passes through the center hole of the front push-pull ring (3) and is connected to the front port of the handle (5). The rear end face of the handle (5) is provided with a socket for the pulse ablation instrument; the side push-pull knob (4) is installed on the side of the handle (5); one end of the pull wire (14) is fixed to the pull ring (13), and the middle part passes through the bending tube (8) axially. The middle part of the proximal tube (9) and the inside of the handle (5) are connected to the side push-pull knob (4); one end of the magnetoelectric positioning sensor wire (15) is connected to the magnetoelectric positioning sensor (12), and the middle part passes through the bending tube (8), the middle part of the proximal tube (9) and the inside of the handle (5) in sequence along the axis, and the other end is electrically connected to the socket; one end of each wire (17) is connected to an end electrode ring (19) or a middle electrode ring (11), and the middle part of all wires passes through the distal tube (7), the bending tube (8), the middle part of the proximal tube (9) and the inside of the handle (5) in sequence along the axis, or the middle part of the bending tube (8), the proximal tube (9) and the inside of the handle (5), and the other end is electrically connected to the socket;The inlet of the irrigation element (6) is connected to a saline container. The outer end of the extension tube passes through the rear end face of the handle (5) and is fixed to the inner liquid cavity (16) of the proximal tube (9) and the rear end of the gap between the proximal tube (9) and the sleeve (2). The outer side of the extension tube is fixed to the side of the handle (5).

2. The adjustable-bend basket ablation catheter according to claim 1, characterized in that: The basket assembly (1) is made of a flexible material including nickel-titanium alloy and has shape memory function. It is spherical or gourd-shaped and can change diameter under the action of the sleeve (2) and the front push-pull ring (3). The end electrode rings (19) on the adjacent skeleton arms (18) are arranged in an up-down or staggered manner.

3. The adjustable-bend basket ablation catheter according to claim 1, characterized in that: The sleeve (2) is a double-layer composite tube. The outer tube is made of at least one of polyether block polyamide and polyurethane. The inner tube is made of PTFE.

4. The adjustable-bend basket ablation catheter according to claim 1, characterized in that: The distal tube (7) is a three-layer composite tube. The outer tube is made of at least one of polyamide and polyether block polyamide. The middle tube is made of 304 stainless steel wire. The inner tube is made of at least one of polyamide and polyether block polyamide.

5. The adjustable-bend basket ablation catheter according to claim 1, characterized in that: The bending pipe (8) is a three-layer composite pipe. The outer layer is made of at least one of polyether block polyamide and thermoplastic polyurethane elastomer. The middle layer is made of 304 stainless steel wire. The inner layer is a four-cavity pipe made of at least one of polyamide, polyether block polyamide and thermoplastic polyurethane elastomer.

6. The adjustable-bend basket ablation catheter according to claim 1, characterized in that: The proximal tube (9) is a three-layer composite tube. The outer tube is made of at least one of polyamide, polyether block polyamide and thermoplastic polyurethane elastomer; the middle tube is made of 304 stainless steel wire braid; and the inner tube is made of PTFE.

7. The adjustable-bend basket ablation catheter according to claim 1, characterized in that: The irrigation element (6) is made of at least one of medical grade PVC, silicone, and thermoplastic polyurethane elastomer. The outer end of the extended tube passes through the rear end face of the handle (5) and is fixed at the liquid cavity (16) inside the proximal tube (9) and at the gap between the proximal tube (9) and the sleeve (2).

8. The adjustable-bend basket ablation catheter according to claim 1, characterized in that: The pull ring (13) and pull wire (14) are made of stainless steel; the head end fixing part (10), the middle electrode ring (11) and the end electrode ring (19) are all made of biocompatible inert materials including platinum-iridium alloy and gold; the insulating sleeve (20) is made of at least one of polyether block polyamide and thermoplastic polyurethane elastomer.

9. A method for preparing an adjustable-bend basket ablation catheter as described in any one of claims 1 to 8, characterized in that: The preparation method includes the following steps performed in sequence: 1) Preparation of proximal tube (9): First, the inner tube is put on the heat shrink mandrel; then the heat shrink mandrel and the inner tube are placed together on the braiding machine; the braiding machine is started to form a middle tube made of 304 stainless steel wire on the inner tube; then the outer tube and the heat shrink tube are put on the middle tube in sequence. After assembly, they are placed together on the lamination heat shrinking machine for heat shrinking. After completion, the heat shrink tube is peeled off, and finally the heat shrink mandrel is pulled out to make the proximal tube (9). 2) Preparation of the distal tube (7) and the bending tube (8): First, place four mandrels in the four cavities of the bending tube (8), and then put the hollow mandrel on the outside of the four mandrels; put the inner tube of the distal tube (7) on the hollow mandrel, with one end overlapping the inner tube of the bending tube (8) which has four cavities, and put the heat shrink tube on its outside. Use a hot air welding machine to make the inner tube of the bending tube (8) and the inner tube of the distal tube (7) into an integral structure; then use a braiding machine to form a middle tube made of 304 stainless steel wire on the inner tube; finally, put the outer tube layer and heat shrink tube of the bending tube (8) and the distal tube (7) on the corresponding middle tube in sequence, heat shrink by a laminating heat shrink machine, peel off the heat shrink tube after completion, and finally pull out all the mandrels and hollow mandrels to make the distal tube (7) and the bending tube (8). 3) Connection of the basket assembly (1): The rear end contraction of the basket assembly (1) with the insulating sleeve (20) and end electrode ring (19) installed is inserted around the front end of the distal tube (7) and axially into the circumferential wall of the head end fixing member (10). Then, the basket assembly (1) and the head end fixing member (10) are glued together. 4) Connection of pull wire (14) and conductor (17): Fix one end of pull wire (14) to pull ring (13); 5) Assembly of the internal structure of the pipeline assembled by the distal tube (7) and the bending tube (8): Place the middle and rear part of the head end fixing part (10), the magnetoelectric positioning sensor (12), the pull ring (13) and the wire (17) of the end electrode ring (19) into the cavity of the distal tube (7), and then lead the wires out to the outside of the bending tube (8); finally, fill the distal tube (7) with glue, adjust the corresponding position, and cure to complete the assembly; 6) Pass the wires (17) of the end electrode ring (19), the middle electrode ring (11), and the magnetoelectric positioning sensor (12) through the inside of the proximal tube (9) and the handle (5) in sequence. Insert the rear end of the pipeline assembled by the distal tube (7) and the bending tube (8) into the front end of the proximal tube (9). Apply epoxy glue to the gaps and connecting surfaces of the pipeline, and then place it in an oven to cure, thereby connecting them into an integrated pipeline. 7) Assembly of the sleeve (2): Insert the integrated pipeline composed of the above-mentioned distal pipe (7), bend-adjusting pipe (8) and proximal pipe (9) into the sleeve (2); 8) Assembly of handle (5) and front push-pull ring (3): Connect the rear ends of sleeve (2) and proximal tube (9) to the front push-pull ring (3) and the front port of handle (5), respectively; 9) Fix the near end tube (9) inside the handle (5) and connect the other end of the pull wire (14) to the side push-pull knob (4); 10) Assembly of irrigation element (6): After passing the outer end of the extension pipe through the rear end face of the handle (5), fix it to the liquid cavity (16) inside the proximal tube (9) and the gap between the proximal tube (9) and the sleeve (2), while the outer side of the extension pipe is fixed to the side of the handle (5). 11) Finally, connect the other end of the wires (17) of the end electrode ring (19), the middle electrode ring (11), and the magnetoelectric positioning sensor (12) to the socket to complete the entire preparation process.

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