Bending-adjustable shock wave microcatheter

Abstract

The utility model relates to a bending-adjustable shock wave micro catheter which comprises a catheter body, and the catheter body comprises an inner-layer tube and an outer-layer tube. The traction ring is fixed in the inner layer pipe, and the traction ring is connected with at least one traction wire; the electrode ring is fixed outside the inner-layer pipe, and an opening is formed in the electrode ring; the far end of the first wire is electrically connected with the electrode ring, and the far end of the second wire penetrates through the lower portion of the electrode ring and extends into the hole. The handle assembly comprises a shell, a Luer connector, a bending adjusting rotary knob, a PCB, a power source and a discharging switch. The functions of bending adjustment and shock wave are integrated on the catheter at the same time, after the shock wave balloon on the surface of the catheter treats calcification, an implant support extends out of a catheter cavity, treatment and implantation are carried out at the same time, back-and-forth instrument switching is reduced, and the operation process is simplified.

Description

TECHNICAL FIELD

[0001] The utility model relates to the field of medical equipment, concretely relates to an adjustable curved shock wave microcatheter. BACKGROUND

[0002] With the continuous development of percutaneous coronary intervention technology, its patients have severe coronary calcification. High-pressure balloon, cutting balloon, coronary rotational atherectomy is a common means for treating severe calcified lesions of coronary artery, but the effect of conventional balloon is often unclear, and the restenosis rate is high after stent implantation. Rotational atherectomy has certain operation difficulty and learning curve, and it is difficult for primary hospitals to widely carry out. The United States Shockwave Medical Company developed a revolutionary intravascular shock wave lithotripsy technology (intravascular lithotripsy, IVL), and the DISRUPT PAD series clinical research confirmed its safety and effectiveness in clinical application. Compared with coronary rotational atherectomy, shock wave lithotripsy is safer, has shorter learning curve, and is easier to popularize and carry out. IVL, as a breakthrough medical technology for calcified lesions, has rapidly gained global recognition from coronary intervention experts with its safe, effective and convenient features, and has become a routine interventional treatment for calcified lesions. This technology is not only effective for superficial calcification, but also the only technology for treating deep calcification. European and American experts have extended IVL case selection to all types of calcification, and CADI and Chinese SOLSTICE studies have also confirmed the safety and effectiveness of IVL in Asian populations.

[0003] The use method of the shock wave balloon system is to enter the target blood vessel through a 0.014-inch guide wire, and to be positioned at the target lesion by the development rings arranged at the proximal and distal ends of the balloon. After the catheter is connected with the device, the device automatically identifies the size of the catheter, and adjusts the output energy. The balloon is filled with a 1:1 saline / contrast agent mixture (which provides the ions needed to generate an electric spark) to 4atm (1atm=101.325kPa). After the balloon is inflated, the liquid-electric shock wave generator is started by controlling the foot pedal, the electrodes inside the balloon emit pulses, each pulse lasts for 10s, and then the balloon inflation pressure is released to restore blood perfusion for 30s; the above operation is repeated 2-3 times. If the lesion is long, the balloon position can be adjusted to ensure that each segment of the lesion receives shock wave pulse treatment. After the calcification is crushed by the shock wave balloon, a drug-eluting stent is used and then expanded. The prior art has the following limitations:

[0004] First, the IVL catheter currently on the market is a rapid exchange balloon structure, which needs to be delivered in conjunction with a 6F guide catheter and is compatible with a 0.014-inch guidewire system. The IVL catheter balloon has a diameter range of 2.5-4.0 mm, a balloon length of 12 mm, and an outer diameter of 1.11-1.19 mm (0.044-0.047 in). After the shock wave shatters the calcification, other devices such as microcatheters and stents need to be switched to continue treatment.

[0005] This method requires the coordination of multiple instruments, which increases the treatment process and delays surgery, increases the number of instruments and increases the financial burden on patients, and increases the outer diameter and causes more damage to patients.

[0006] Secondly, current products require manual operation by the doctor under DSA, and cannot be used in conjunction with currently advanced interventional surgical robots. This makes it inconvenient for the surgeon to perform the surgery remotely and also exposes the surgeon to more radiation. This invention aims to optimize the surgical operation process and achieve simplified product integration and remote control. Utility Model Content

[0007] The technical problem to be solved by the present invention is to overcome the deficiencies of the existing technology and provide an adjustable bend shock wave microcatheter to solve the technical problems that the existing catheter needs to be combined with multiple instruments during the treatment process, which increases the treatment process and delays the operation, and increases the number of instruments and increases the economic burden on patients.

[0008] The technical solution adopted by the utility model to solve its technical problems is:

[0009] Provided is an adjustable bend shock wave microcatheter, comprising

[0010] The catheter body comprises an inner tube and an outer tube, an annular cavity is formed between the inner tube and the outer tube, and a balloon is provided at the front end of the outer tube;

[0011] A traction ring is fixed in the inner tube and is connected to one or two traction wires. The traction wires are led out from the proximal end of the inner tube and connected to the bending knob on the handle assembly.

[0012] An electrode ring, a first wire, and a second wire, wherein the electrode ring is fixed to the outside of the inner tube and is provided with an opening; the proximal ends of the two wires pass through the proximal end of the compartment cavity, the distal end of the first wire is electrically connected to the electrode ring, and the distal end of the second wire passes under the electrode ring and extends into the opening, forming a discharge gap between the conductor of the second wire and the electrode ring;

[0013] A handle assembly includes a housing, a Luer connector, a bending knob, a PCB, a power supply, and a discharge switch. The bending knob, PCB, power supply, and discharge switch are all disposed on the housing. The PCB is electrically connected to two wires, the power supply, and the discharge switch, respectively. The bending knob is connected to the traction wire.

[0014] The Luer connector is arranged at the front end of the shell, and the Luer connector is communicated with the liquid channel in the outer tube. The rear end of the inner tube passes through the Luer connector and extends from the rear end of the shell.

[0015] Furthermore, an insulating ring is provided between the electrode ring and the inner tube, and the electrode ring is installed on the inner tube through the insulating ring. The insulating ring is also provided with an opening, and the opening of the insulating ring and the opening of the electrode ring are concentric circles. The second wire passes between the insulating ring and the electrode ring.

[0016] Furthermore, the outer tube and the balloon are bonded or welded.

[0017] Furthermore, the electrode ring is made of platinum-iridium, stainless steel or platinum-tungsten.

[0018] Furthermore, a bending adjustment mechanism is provided between the bending adjustment knob and the traction wire, and the bending adjustment mechanism is provided in the housing;

[0019] The bending adjustment mechanism includes an inner support and a slider.

[0020] The inner support is fixedly arranged in the shell, and the inner tube passes through the inner support and is fixed to the inner support by glue dispensing;

[0021] The inner support is provided with a slide groove, the slider is arranged in the slide groove, the traction wire passes through the slide groove and is connected to the slider, the slider is provided with an external thread, the bending adjustment knob is sleeved on the outside of the inner support, and a spiral groove is provided in the bending adjustment knob, and the spiral groove cooperates with the external thread;

[0022] Rotate the bending knob to drive the slider to move on the inner support, thereby driving the traction wire to pull the front end of the catheter.

[0023] Furthermore, a bending adjustment mechanism is provided between the bending adjustment knob and the traction wire, and the bending adjustment mechanism is provided in the housing;

[0024] The bending adjustment mechanism includes an inner support and two sliders.

[0025] The inner support is fixedly arranged in the shell, and the inner tube passes through the inner support and is fixed to the inner support by glue dispensing;

[0026] Two sliding grooves are formed on the inner support, two sliding blocks are arranged in the sliding grooves respectively, two traction wires are arranged in the sliding grooves and connected with the two sliding blocks respectively, external threads are arranged on the sliding blocks, the bending adjusting knob is sleeved outside the inner support, two spiral grooves are formed in the bending adjusting knob, the rotation directions of the two spiral grooves are opposite, and the two spiral grooves are matched with the external threads of the two sliding blocks respectively.

[0027] The bending adjusting knob is rotated, and the two sliding blocks are driven to move in the inner support in opposite directions.

[0028] The utility model discloses the beneficial effects are:

[0029] The utility model discloses adjustable bending shock wave microcatheter, the function of adjusting bending and shock wave is gathered simultaneously on the catheter, after the shock wave balloon treatment calcification of catheter surface, implant support stretches out from the catheter lumen, and treatment and implant are carried out simultaneously, reduce back and forth switching equipment, simplify surgical procedure.

[0030] Through the catheter of the utility model, treatment procedure can be simplified, operation delay can be avoided, the number of instruments can be reduced, the economic burden of patients can be reduced, the outer diameter can be reduced, and more damage to patients can be avoided. DRAWINGS

[0031] The utility model is further described below in combination with the drawings.

[0032] Figure 1 And Figure 2 It is adjustable bending shock wave microcatheter schematic diagram of the utility model;

[0033] Figure 3 It is handle assembly schematic diagram;

[0034] Figure 4 It is the structure diagram between catheter body and luer joint;

[0035] Figure 5 It is the structure diagram between catheter body and PCB circuit board;

[0036] Figure 6 It is inner layer pipe sectional view;

[0037] Figure 7 It is bending adjusting mechanism schematic diagram;

[0038] Wherein, 1, inner layer pipe, 11, wire hole;

[0039] 2, outer layer pipe,

[0040] 3, balloon;

[0041] 4, traction ring, 41, traction wire;

[0042] 5, electrode ring, 51, first wire, 52, second wire;

[0043] 61, housing, 62, luer, 63, bending knob, 64, PCB, 65, discharge switch

[0044] 71, inner support, 72, slider DETAILED DESCRIPTION

[0045] To make the purpose, technical scheme and advantages of the embodiments of the present application clearer, the technical scheme of the present application will be described below in connection with the drawings. Obviously, the described embodiments are only some of the embodiments of the present application, rather than all the embodiments. Based on the embodiments in the present application, all other embodiments obtained by those of ordinary skill in the art without creative labor fall within the scope of the present application.

[0046] The present application provides an adjustable bending shock wave microcatheter, which is described in detail below. It should be noted that the description order of the following embodiments is not used as a limitation on the preferred order of the embodiments of the present application. Moreover, the description of each embodiment in the following embodiments has its own emphasis, and the parts not described in detail in a certain embodiment can be referred to the related description of other embodiments.

[0047] To solve the technical problem that the catheter needs to be matched with multiple instruments during treatment in the prior art, increases the treatment process, delays the operation, increases the number of instruments, and increases the economic burden of the patient, an embodiment of the present application provides an adjustable bending shock wave microcatheter. The following is described in detail.

[0048] As shown in Figures 1 to 6 An adjustable bending shock wave microcatheter includes

[0049] A catheter body includes an inner tube 1 and an outer tube 2, an annular separation cavity is formed between the inner tube 1 and the outer tube 2, and a balloon 3 is arranged at the front end of the outer tube 2;

[0050] A traction ring 4 is fixed in the inner tube 1, the traction ring 4 is connected to one or two traction wires 41, the traction wires 41 are led out from the proximal end of the inner tube 1 and connected to a bending knob 63 on a handle assembly;

[0051] An electrode ring 5, a first wire 51 and a second wire 52, the electrode ring 5 is fixed outside the inner tube 1, and the electrode ring 5 is provided with an opening; the proximal ends of the two wires are led out from the proximal end of the separation cavity, the distal end of the first wire 51 is electrically connected to the electrode ring 5, the distal end of the second wire 52 passes below the electrode ring 5 and extends into the opening, and a discharge gap is formed between the conductor of the second wire and the electrode ring 5;

[0052] The handle assembly comprises a shell 61, a luer joint 62, a bending knob 63, a PCB circuit board 64, a power supply and a discharge switch 65, the bending knob 63, the PCB circuit board 64, the power supply and the discharge switch 65 are arranged on the shell 61, the PCB circuit board 64 is electrically connected with two wires, the power supply and the discharge switch 65 respectively, and the bending knob 63 is connected with the traction wire 41.

[0053] The luer joint 62 is arranged at the front end of the shell 61, the luer joint 62 is communicated with the liquid channel in the outer tube 2, and the rear end of the inner tube 1 passes through the luer joint 62 and extends out of the rear end of the shell 61.

[0054] Specifically, as an optional embodiment of the embodiment, an insulating ring is arranged between the electrode ring 5 and the inner tube 1, the electrode ring 5 is mounted on the inner tube 1 through the insulating ring, the insulating ring is also provided with an opening, the opening of the insulating ring is a concentric circle with the opening of the electrode ring 5, and the second wire 52 passes through between the insulating ring and the electrode ring 5.

[0055] The insulating ring is made of polyimide.

[0056] Specifically, as an optional embodiment of the embodiment, the outer tube 2 and the balloon 3 are bonded or welded.

[0057] Specifically, as an optional embodiment of the embodiment, the electrode ring 5 is made of platinum-iridium, stainless steel or platinum-tungsten.

[0058] As shown in the sectional view of the inner tube 1, Figure 6 The inner tube 1 is provided with a lumen and a wire hole 11, the wire hole 11 is used for passing the traction wire 41, and the traction ring 4 is integrally formed in the inner tube 1 in the injection molding process. The front end of the traction wire 41 is welded with the traction ring 4, the rear end of the traction wire 41 passes out of the wire hole 11 and is connected with the bending knob 63, the angle of the catheter head end can be controlled by controlling the rotation of the driving bending knob 63, so as to select the direction of advancement, after reaching the treatment site, the balloon 3 is inflated, and the discharge button is clicked to discharge treatment.

[0059] As shown in the sectional view of the inner tube 1, Figure 7 Taking the catheter with two traction wires 41 as an example,

[0060] The bending mechanism is arranged in the shell between the bending knob 63 and the traction wire 41.

[0061] The bending mechanism comprises an inner support 71 and two sliding blocks 72.

[0062] The inner support 71 is fixedly arranged in the shell, the inner tube passes through the inner support 71 and is fixed between the inner support 71 by the point gluing mode.

[0063] Two slide grooves are provided on the inner support member 71, and two sliders 72 are respectively arranged in the slide grooves. The two traction wires 41 pass through the two slide grooves and are respectively connected to the two sliders 72. The sliders 72 are provided with external threads. The bending adjustment knob 63 is sleeved on the outside of the inner support member 71. Two spiral grooves are provided in the bending adjustment knob 63. The rotation directions of the two spiral grooves are opposite. The two spiral grooves are respectively matched with the external threads of the two sliders 72.

[0064] Rotating the bending knob 63 drives the two sliders 72 to move in opposite directions on the inner support member 71 .

[0065] Specifically, assuming that the bending knob 63 is rotated forward, the first slider and the first traction wire move backward to cause the catheter tip to bend to the right. At the same time, the second slider and the second traction wire move forward synchronously to match the bending of the catheter tip.

[0066] Assume that the bending knob 63 is rotated in the opposite direction, the second slider and the second traction wire are moved backward to drive the catheter tip to bend to the left. At the same time, the first slider and the first traction wire are moved forward synchronously to match the bending of the catheter tip.

[0067] When a traction wire 41 is provided on the catheter, referring to the above embodiment, the number of the slider 72 and the number of the spiral groove are both one.

[0068] In order to realize remote operation of the catheter, a gear ring may be provided on the bending knob 63 , and the gear ring cooperates with an external electric mechanism to drive the bending knob 63 to rotate electrically.

[0069] The lumen in the middle of the inner tube 1 is used to provide a passage for devices such as stents.

[0070] The inner tube 1 may be a braided structure or a braided plus spring structure.

[0071] like Figure 1 and Figure 2 As shown, the distal end of the balloon 3 is sealedly connected to the inner tube, which can be combined by gluing or welding, and the balloon 3 is filled with a mixture of contrast agent and physiological saline from the Luer interface of the filling cavity of the balloon 3.

[0072] Figure 3 As shown, the bending knob 63 on the handle assembly is set to rotate, the traction wire 41 passes through the side wall of the inner tube 1, and then the traction wire 41 is connected to the bending knob 63. By rotating the bending knob 63, the direction of the front end of the inner tube 1 can be adjusted.

[0073] like Figure 4As shown, the luer joint 62 is connected to the outer tube 2 at the front end, and through the luer joint 62 and the outer tube 2, liquid can be injected into the balloon 3, and the inner tube 1 passes through the luer joint 62, and the rear end of the inner tube 1 extends out of the shell, and is used for inserting a stent into the inner tube 1.

[0074] As shown in the drawings, Figure 5 As shown, the traction wire 41 passes out of the side wall of the inner tube 1, and the two wires pass out of the partition cavity and are connected to the PCB circuit board 64.

[0075] The adjustable bending shock wave microcatheter of the utility model has the functions of bending and shock wave at the same time, after the shock wave balloon 3 on the surface of the catheter is used for treating calcification, the implant stent extends out of the catheter lumen, treatment and implantation are simultaneously performed, switching of equipment back and forth is reduced, and the surgical procedure is simplified.

[0076] Through the catheter, the treatment procedure can be simplified, surgery is avoided, the number of instruments is reduced, the economic burden of patients is reduced, the outer diameter is reduced, and more damage to patients is avoided.

[0077] Shock wave treatment of calcification working process: two wires are welded to obtain programs, and the PCB circuit board 64 is connected to a power supply to obtain power. The discharge switch 65 is pressed, the second wire is electrified, the voltage is 3000V, the discharge gap on the electrode ring 5 is broken after electrification, a loop is formed with the first wire 51 to generate an impact wave, and the electrode discharge generates an impact wave to treat calcification.

[0078] The adjustable bending function of the application can be combined with remote treatment of a robot, and a surgical robot remotely controls the steering of the distal end of the pipe body, and selects a corresponding target blood vessel.

[0079] The catheter integrates two functions, that is, the adjustable bending microcatheter is combined with the shock wave balloon 3, after the shock wave balloon 3 on the surface of the catheter is used for treating calcification, the implant stent extends out of the catheter lumen, treatment and implantation are simultaneously performed, switching of equipment back and forth is reduced, and the surgical procedure is simplified.

[0080] Each device (parts without specific structure) selected in the application is a general standard part or a part known to those skilled in the art, and the structure and principle thereof can be known by a person skilled in the art through a technical manual or through a conventional experimental method.

[0081] In the description of the embodiments of the utility model, unless another definite provision and limitation, the term " install " " link " " connection " should do the broad sense understanding, for example, can be fixed connection, also can be detachable connection, or integrally connected, can be mechanical connection, also can be electrical connection, can be direct connection, also can indirectly connect through the intermediate medium, can be the intercommunication of two elements. For ordinary skilled in the art, the specific meaning of the above-mentioned terms in the utility model can be understood according to the specific circumstances.

[0082] In the description of the utility model, it should be explained that the orientation or position relationship indicated by the terms "center", "upper", "lower", "left", "right", "vertical", "horizontal", "inner", "outer" and the like is based on the orientation or position relationship shown in the drawings, and is only for the convenience of describing the utility model and simplifying the description, and does not indicate or imply that the devices or elements referred to must have a particular orientation, be constructed and operated in a particular orientation, and therefore cannot be understood as a limitation on the utility model. In addition, the terms "first", "second", "third" are only for the purpose of description, and cannot be understood as indicating or implying relative importance.

[0083] In several embodiments provided in the present application, it should be understood that the disclosed system, device and method can be implemented in other ways. The device embodiments described above are only schematic, for example, the division of the units is only a logical function division, and actual implementation can have another division manner, and for example, a plurality of units or components can be combined or integrated into another system, or some features can be ignored or not executed. In addition, the coupling or direct coupling or communication connection between the units shown or discussed can be indirect coupling or communication connection through some communication interfaces, devices or units, which can be electrical, mechanical or other forms.

[0084] The units described as separate components can or can not be physically separated, and the components shown as units can or can not be physical units, i.e. they can be located in one place or distributed on a plurality of network units. Some or all of the units can be selected according to actual needs to achieve the purpose of the embodiment scheme.

[0085] In addition, the functional units in each embodiment of the utility model can be integrated in one processing unit, or each unit can exist physically, or two or more units can be integrated in one unit.

[0086] With the above ideal embodiment of the present application as the inspiration, through the above description, relevant staff can make various changes and modifications without deviating from the technical idea of the present application. The technical scope of the present application is not limited to the content in the specification, and the technical scope must be determined according to the scope of claims.

Claims

1. An adjustable bend shockwave microcatheter, characterized by, Comprising a catheter body comprising an inner tube (1) and an outer tube (2), an annular compartment is formed between the inner tube (1) and the outer tube (2), a balloon (3) is arranged at the front end of the outer tube (2); a traction ring (4) is fixed in the inner tube (1), the traction ring (4) is connected to one or two traction wires (41), the traction wires (41) are led out from the proximal end of the inner tube (1) and connected to the bending knob (63) on the handle assembly; an electrode ring (5), a first lead wire (51) and a second lead wire (52), the electrode ring (5) is fixed outside the inner tube (1), the electrode ring (5) is provided with an opening; the proximal ends of the two lead wires are led out from the proximal end of the compartment, the distal end of the first lead wire (51) is electrically connected to the electrode ring (5), the distal end of the second lead wire (52) passes through below the electrode ring (5) and extends into the opening, and a discharge gap is formed between the conductor of the second lead wire and the electrode ring (5); a handle assembly comprising a shell (61), a luer connector (62), a bending knob (63), a PCB circuit board (64), a power supply and a discharge switch (65), the bending knob (63), the PCB circuit board (64), the power supply and the discharge switch (65) are arranged on the shell (61), the PCB circuit board (64) is electrically connected to the two lead wires, the power supply and the discharge switch (65) respectively, and the bending knob (63) is connected to the traction wire (41); the luer connector (62) is arranged at the front end of the shell (61), the luer connector (62) is in communication with the liquid channel in the outer tube (2), and the rear end of the inner tube (1) passes through the luer connector (62) and extends out from the rear end of the shell (61).

2. The adjustable bending shock wave microcatheter according to claim 1, wherein an insulating ring is arranged between the electrode ring (5) and the inner tube (1), the electrode ring (5) is mounted on the inner tube (1) through the insulating ring, the insulating ring is also provided with an opening, the opening of the insulating ring and the opening of the electrode ring (5) are concentric circles, and the second lead wire (52) passes through between the insulating ring and the electrode ring (5).

3. The adjustable bending shock wave microcatheter according to claim 1, wherein the outer tube (2) and the balloon (3) are bonded or welded.

4. The adjustable bending shock wave microcatheter according to claim 1, wherein the electrode ring (5) is made of platinum-iridium, stainless steel or platinum-tungsten.

5. The adjustable bending shock wave microcatheter according to claim 1, wherein a bending mechanism is arranged between the bending knob (63) and the traction wire (41), and the bending mechanism is arranged in the shell; the bending mechanism comprises an inner support (71) and a slider (72), the inner support (71) is fixedly arranged in the shell, the inner tube passes through the inner support (71) and is fixed between the inner support (71) by means of point gluing. The inner support (71) is provided with a sliding groove, the sliding block (72) is arranged in the sliding groove, the traction wire (41) is arranged in the sliding groove and connected with the sliding block (72), the sliding block (72) is provided with external threads, the bending adjusting knob (63) is sleeved outside the inner support (71), the bending adjusting knob (63) is provided with a spiral groove, and the spiral groove is matched with the external threads. The bending adjusting knob (63) is rotated to drive the sliding block (72) to move on the inner support (71), so that the traction wire (41) pulls the front end of the catheter.

6. The adjustable bending shock wave microcatheter according to claim 1, wherein, The bending adjusting knob (63) and the traction wire (41) are provided with a bending adjusting mechanism, and the bending adjusting mechanism is arranged in the shell; The bending adjusting mechanism comprises an inner support (71) and two sliding blocks (72), The inner support (71) is fixedly arranged in the shell, and the inner layer pipe passes through the inner support (71) and is fixed between the inner support (71) by means of point gluing; The inner support (71) is provided with two sliding grooves, the two sliding blocks (72) are arranged in the sliding grooves respectively, the two traction wires (41) are arranged in the two sliding grooves and connected with the two sliding blocks (72) respectively, the sliding block (72) is provided with external threads, the bending adjusting knob (63) is sleeved outside the inner support (71), the bending adjusting knob (63) is provided with two spiral grooves, the rotating directions of the two spiral grooves are opposite, and the two spiral grooves are matched with the external threads of the two sliding blocks (72) respectively. The bending adjusting knob (63) is rotated to drive the two sliding blocks (72) to move on the inner support (71) in opposite directions.

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