DEVICE AND METHOD FOR ELECTROTHROMBOSIS

Abstract

The application relates to an electrotherapeutic device for inducing thrombosis, which includes a power source and a guide wire portion.

Claims

1. A device, comprising a power source (1), an output guide wire (2) and an input guide wire (4), wherein the output guide wire (2) is connected to an anode (3) of the power source (1); and the input guide wire (4) is connected to a cathode (5) of the power source (1).

2. The device of claim 1, wherein the power source (1) is a stent releaser.

3. The device of claim 2, wherein the power source (1) is a Solitaire stent releaser.

4. The device of claim 1, wherein the power source (1) comprises: a power supply portion, comprising an internal power source, wherein the internal power source is a direct current power source, of which voltage is 10-40 V; a current control portion, comprising a voltage stabilizer, a diode, a first resistor, a second resistor and a third resistor, wherein an input terminal of the voltage stabilizer is connected with the internal power source, and an output terminal thereof is divided into two branches which are respectively connected with the first resistor and the third resistor; the diode is connected with a third terminal of the voltage stabilizer and connected with the second resistor in series; a resistance value of the first resistor is 200-400; a resistance value of the second resistor is 5-40; and a resistance value of the third resistor is 500-4000 ; a regulating portion, comprising a first rheostat and a second rheostat, wherein the first rheostat and the third resistor, which are connected in series, are connected with the second rheostat together in parallel; the maximum resistance value of the first rheostat is 5-15 k; and the maximum resistance value of the second rheostat is 10-30 k; and an output portion, comprising an ammeter and an external electrode which are connected with the first rheostat and the third resistor in series.

5. The device of claim 4, wherein the power source (1) further comprises a position converter, wherein the position converter is connected with the first rheostat in series and has two, three, four or five switching positions; and the resistance values of the resistors connected to the corresponding switching positions are 0-30 k.

6. The device of claim 4, wherein in the power source (1), the voltage of the internal power source is 24 V; the voltage stabilizer is formed by connecting two LM117HVH three-terminal voltage stabilizers in series; the diode is formed by connecting two diodes in series; the resistance value of the first resistor is 330; the resistance value of the second resistor is 20; the resistance value of the third resistor is 2000; the maximum resistance value of the first rheostat is 10 k; and the maximum resistance value of the second rheostat is 20 k.

7. The device of claim 1, wherein the output guide wire (2) is a Traxcess guide wire.

8. The device of claim 7, wherein the output guide wire (2) is a Traxcess-14 guide wire.

Description

BRIEF DESCRIPTION OF THE DRAWINGS

[0020] FIG. 1 is a schematic diagram of a device of the application.

[0021] FIG. 2 is a circuit diagram of a power source for the application.

[0022] FIG. 3A is a radiographic image of Case 1 after being applied with an intracranial stent.

[0023] FIG. 3B is a radiographic image of Case 1 using a guide wire.

[0024] FIG. 3C is a radiographic image of Case 1 after being charged with electricity three times by a Solitaire stent releaser for 6 minutes in total.

[0025] FIG. 3D is a DSA image of Case 1 re-examined 6 months after electrotherapy.

[0026] FIG. 4A is a radiographic image of basilar artery perforating branch microaneurysms before electrothrombosis operation in Case 2.

[0027] FIG. 4B is a radiographic image of Case 2 after being charged with electricity three times by the Solitaire stent releaser for 6 minutes in total.

[0028] FIG. 5A is a radiographic image before electrothrombosis operation in Case 3.

[0029] FIG. 5B is a radiographic image of Case 3 after being charged with electricity three times by the Solitaire stent releaser for 6 minutes in total.

DETAILED DESCRIPTION OF THE INVENTION

[0030] As mentioned above, a device of the application includes (or consists of) a power source and a guide wire portion.

[0031] The power source can be a commercially available constant current power source or constant voltage power source. The applicant discovered in clinical practice that the constant current power source has more advantages than the constant voltage power source as follows: although the constant voltage power source can provide constant output voltage, the stability and controllable output of current will be affected due to the individual differences in human body resistance of each person which cannot maintain stability at all times, while the constant current power source can directly provide constant current, which is more conducive to the stability of external conditions for thrombosis and the controllability of heat.

[0032] In a specific embodiment, the output current of the power source is about 0.1-50 mA, 0.2-20 mA, 0.5-10 mA or 0.8-5 mA. In another specific embodiment, the output current of the power source is about 0.8 mA, 1 mA, 1.5 mA, 2 mA, 3 mA, or 5 mA.

[0033] The applicant also surprisingly discovered that a commercially available stent releaser, such as a Solitaire stent releaser, can be used as a power source for the application. The stent releaser mainly uses the electrolysis principle in stent releasing, which has no relation with thrombosis in general medical practice. However, the inventors of the application unexpectedly discovered that the stent releaser can be advantageous in the electric thrombosis method of the application due to its stable and safe voltage (e.g., about 9 V), especially relatively constant current (e.g., about 0.8-1.0 mA) in the process of being power-supplied. Therefore, the application in another aspect relates to a use of a stent releaser (e.g., a Solitaire stent releaser) in electrothrombosis therapy and a use of the same in manufacturing a device for thrombosis.

[0034] In addition to using the stent releaser as a guest power source, other suitable power sources can also be used. For example, the inventors of the application design a power source which includes the following components: an internal power source, a voltage stabilizer, a diode, a first resistor, a second resistor, a third resistor, a first rheostat, an ammeter, an external electrode and a second rheostat, wherein the internal power source forms a power supply portion; the voltage stabilizer, the diode, the first resistor, the second resistor and the third resistor form a current control portion; the first rheostat and the second rheostat form a regulating portion; and the ammeter and the external electrode form an output portion. The regulating portion optionally further includes a position converter to switch the current between different switching positions, thereby constantly outputting corresponding current. Considering that subcutaneous resistance of a human body is generally not more than 500, the resistance ranges of the various resistors and rheostats can be determined as follows.

[0035] In the power supply portion, the internal power source can directly adopt a direct current power source or form a direct current power source by converting external alternating current into direct current. Direct current output voltage of the power source may be about 10 V, 2 V, 14 V, 16 V, 18 V, 20 V, 22 V, 24 V, 26 V, 28 V, 30 V, 32 V, 34 V, 36 V, 38 V or 40 V, for example, a 24 V direct current power source is used.

[0036] In the current control portion, the voltage stabilizer is configured to ensure that a circuit voltage of the output portion is relatively stable. The voltage stabilizer can adopt a common three-terminal voltage stabilizer in the market, for example, an LM117HVH three-terminal voltage stabilizer. An output terminal of the voltage stabilizer is divided into two branches which are respectively connected with the first resistor for voltage division and the third resistor for current limiting. The reason why the third resistor for current limiting needs to be provided is that the resistance values of different living bodies vary greatly, which may also lead to excessive current variation. Therefore, it is necessary to provide the resistor for current limiting here for safety. A resistance value of the first resistor may be about 200 , 220 , 230 , 250 , 280 , 300 , 320 , 30 , 350 , 380 or 400. A resistance value of the third resistor may be about 500, 1000, 1500, 2000, 2500, 3000, 3500 or 4000.

[0037] In addition, the diode is connected to a third terminal of the voltage stabilizer and connected with the second resistor in series, thereby protecting the voltage stabilizer from being damaged due to excessively high output voltage. Specifically, when the output terminal of the voltage stabilizer is connected with a large capacitor and an input terminal thereof has a small voltage holding capacity, a situation that the potential of the output terminal is higher than that of the input terminal will occur after power off, therefore, the diode needs to be arranged to allow the capacitor at the output terminal of the voltage stabilizer to discharge to the input terminal so as to protect the voltage stabilizer. One or more (e.g., one, two or three) diodes may be connected in series according to the need for current regulation. A resistance value of the second resistor may be about 5 , 10 , 15 , 20 , 25 , 30 , 35 , 40.

[0038] In the regulating portion, the first rheostat is connected with the third resistor in series; the first rheostat and the third resistor together are connected with the second rheostat in parallel; and the first rheostat is configured to regulate current in a large range between different living bodies (for example, between different patients). The maximum resistance value of the first rheostat may be about 5 k, 5.5 k, 6 k, 6.5 k, 7 k, 7.5 k, 8 k, 8.5 k, 9 k, 9.5 k, 10 k, 10.5 k, 11 k, 11.5 k, 12 k, 12.5 k, 13 k, 13.5 k, 14 k, 14.5 k, or 15 k. The first rheostat may be provided with several (for example, three) switching positions, and the resistance values of the switching positions may be about 0.5 k, 1 k, 1.5 k, 2 k, 2.5 k, 3 k, 3.5 k, 4 k, 4.5 k, 5 k, 5.5 k, 6 k, 6.5 k, 7 k, 7.5 k, 8 k, 8.5 k, 9 k, 9.5 k, 10 k, 10.5 k, 11 k, 11.5 k, 12 k, 12.5 k, 13 k, 13.5 k, 14 k, 14.5 k, and 15 k.

[0039] The second rheostat is configured to fine-tune the current when the living body fluctuates in a small range (for example, when operating on the same patient). The maximum resistance value of the second rheostat may be about 10 k, 11 k, 12 k, 13 k, 14 k, 15 k, 16 k, 17 k, 18 k, 19 k, 20 k, 21 k, 22 k, 23 k, 24 k, 25 k, 26 k, 27 k, 28 k, 29 k, or 30 k. The second rheostat may also be provided with several (for example, three) switching positions, and the resistance values of the switching positions may be about 1 k, 2 k, 3 k, 4 k, 5 k, 6 k, 7 k, 8 k, 9 k, 10 k, 11 k, 12 k, 13 k, 14 k, 15 k, 16 k, 17 k, 18 k, 19 k, 20 k, 21 k, 22 k, 23 k, 24 k, 25 k, 26 k, 27 k, 28 k, 29 k or 30 k.

[0040] The regulating portion may also include the position converter connected with the first rheostat and the third resistor in series, and the function of current switching is realized by switching a control switch to different switching positions. The number of the switching positions may be two, three, four or five, etc. each of the switching positions is connected with a certain resistor so as to adjust the current within the range of the above-mentioned output current; and the resistance value of the resistor is related to the third resistor and the first rheostat, as well as to the resistance of different living bodies. For example, the resistance value of the resistor connected to each switching position can be about 0 k, 0.3 k, 0.5 k, 1 k, 2 k, 3 k, 4 k, 5 k, 6 k, 7 k, 8 k, 9 k, 10 k, 11 k, 12 k, 13 k, 14 k, 15 k, 16 k, 17 k, 18 k, 19 k, 20 k, 21 k, 22 k, 23 k, 24 k, 25 k, 26 k, 27 k, 28 k, 29 k or 30 k respectively so as to control the output current at about 0.5 mA, 1 mA, 1.5 mA, 2 mA, 2.5 mA, 3 mA, 3.5 mA, 4 mA, 4.5 mA or 5 mA.

[0041] In the output portion, the ammeter is an ammeter commonly used in the industry, which is configured to indicate the current in electrothrombosis operation, and may act as a portion of the panels 6 described above. The measuring range of the ammeter matches the common current range of electrothrombosis, such as being 0-5 mA, 0-10 mA, 0-20 mA or 0-50 mA, etc. When in use, the first rheostat and/or the second rheostat can be regulated according to the readings of the ammeter. The external electrode corresponds to the above-mentioned anode 3 and cathode 5. The ammeter and the external electrode are connected with the first rheostat and the third resistor in series.

[0042] For the above-mention power source, FIG. 2 shows a specific embodiment. The internal power source is a 24 V direct current power source, an output terminal of which is connected with two LM117HVH three-terminal voltage stabilizers U1 and U2 which are connected in series; and an output terminal of U2 is divided into two branches which are respectively connected with a first resistor R1 (330) and a third resistor R6 (2000). In addition, one terminal of U2 is connected with two diodes D1 and D2 and a second resistor R5 (20) in series to feed the current back to U1 so as to protect U1 and U2. The first rheostat R2, the position converter, the ammeter XMM1 and the external electrode are connected with the third resistor R6 in series, and the series circuit is connected with the second rheostat R3 in parallel. The maximum resistance value of the first rheostat R2 is 10 k; and the maximum value of the second rheostat R3 is 20 k. The position converter has three switching positions which are connected with resistors R4, R7 and R8 respectively, so that the corresponding output currents are about 1 mA, 2 mA and 5 mA respectively.

[0043] In addition, the output guide wire of the application can adopt a guide wire commonly used in clinic. Preferably, the guide wire is provided with a head end with good conductivity, moderate heat generation and electrolytic resistance.

[0044] The inventors of the application unexpectedly discovered that commercially available Traxcess series guide wires, such as a Traxcess-14 guide wire, are very suitable for use as an output guide wire of the application. The Traxcess guide wire was originally only used for general intravascular diagnosis or treatment by cooperating with a microcatheter, and there were no reports of its use in thrombosis. Due to its good conductivity and strong electrolytic resistance (e.g., the proximal of the Traxcess-14 guide wire has an insulating coating over 140 cm except for about 3 cm at the tail end, which is beneficial to the concentration of positive charge to the head end covered by an inert platinum coil), the Traxcess guide wire is adapted to be used as the guide wire being charged with electricity in the method for electrothrombosis of the application. Therefore, the application in another aspect relates to a use of the Traxcess guide wire, especially the Traxcess-14 guide wire, in electrothrombosis therapy and to a use in manufacturing a device for thrombosis.

[0045] The output guide wire of the application (for example, at the head end) is optionally equipped with a device for measuring a temperature or for temperature alarm, and/or an auxiliary device for introducing a microcatheter.

[0046] The input guide wire used in the application can be a guide wire commonly used in clinic, for example, a wire provided on an electrode of a common medical power source or a stent releaser can be used as the input guide wire. The input guide wire can be connected with a metal syringe needle and pricked under the skin of a human body (for example, under the skin of a thigh), or be tied at an appropriate position on the human body, or be pasted on the skin through a patch, thereby realizing circuit communication with the human body and forming a loop. Under the condition of not being pricked under the skin, one should pay attention to the fact that the resistance value of the human body will become larger. In order to ensure proper current, the parameters of the power source, such as voltage and internal resistance, should be regulated accordingly.

[0047] The application also relates to a use of a combination of a Solitaire stent releaser and a Traxcess-14 guide wire in electrothrombosis therapy and a use in manufacturing a device for thrombosis.

Examples

[0048] The following cases treated with the method and device of the application are aneurysms which are difficult to treat by conventional treatment methods, and the immediate postoperative effect and reexamination effect are very ideal.

[0049] Materials and Method

[0050] A commercially available Traxcess-14 guide wire is used as an output guide wire, the tail end (namely, the conductive end without the coating) is connected to the anode of the Solitaire stent releaser, the head end of the guide wire is super-selected to an aneurysm cavity, and all guide wire portions inside of the body up to a tumor neck are isolated beyond the range of blood circulation by the microcatheter. In the thigh portion, a needle (a metal needle capable of conducting electricity, such as a common syringe needle) penetrates into the skin and is connected with a wire (serving as an input guide wire) on the cathode of the power source of the Solitaire stent releaser, so that positive charges converge at the aneurysm cavity, and current passes through a subcutaneous resistor of the human body and returns to the cathode of the release device via a thigh needle, thereby forming a complete loop (the principle is exactly the same as that of the release device).

[0051] During operative procedures, the head end of the guide wire is super-selected into the aneurysm cavity, the proximal end of the tumor neck is protected by the microcatheter in the whole process, the power source of the Solitaire stent releaser is powered on to realize the electrothrombosis operation in a intermittent way, and the current is controlled at about 1 mA when being powered on. Three times of such operation form one stage and one stage is followed by angiography until the effect is satisfactory.

[0052] Case Description

[0053] Case 1: a male who was 15 years old was injured after falling down when riding a motorcycle. He has multiple dissecting aneurysms and pseudoaneurysms at bilateral carotid arteries. With the above-mentioned operation, pseudoaneurysm to which the microcatheter cannot enter is subjected to eletrotherapy merely.

[0054] The therapeutic process is shown in FIGS. 3A-3D. FIG. 3A shows that an ophthalmic artery segment pseudoaneurysm is still developed after being applied with an intracranial stent, and the conventional microcatheter cannot pass through a mesh. FIG. 3B shows that the Traxcess-14 guide wire is utilized, wherein the head end thereof can reach the tumor cavity and the microcatheter also can follow to the mesh of the intracranial stent. FIG. 3C shows that after the Solitaire stent releaser is powered on three times for 6 minutes in total, the tumor cavity is not developed obviously, indicating that an electric thrombus is well formed. FIG. 3D is a DSA image by reexamined 6 months after electric therapy, indicating that the electric thrombus is well maintained, and showing that the thrombus formed by the device and method of the application have a lasting effect.

[0055] Case 2: a male who was 49 years old was admitted to hospital due to subarachnoid hemorrhage (SAH). As shown in the angiography in FIG. 4A, basilar artery perforating branch microaneurysms exist at the position indicated by the arrow. Since the pseudoaneurysm is so tiny that the conventional microcatheter cannot enter easily, the above-mentioned operation is adopted for electric therapy. After the Solitaire stent releaser is powered on three times for 6 minutes in total, the tumor cavity is not developed obviously. As shown in FIG. 4B, it shows that the electric thrombus is also well formed.

[0056] Case 3: a female who was 51 years old had a headache and had vomited for 10 days. Head CT showed hematocele in a prepontine cistern, an annular cistern and a fourth ventricle, and Head CTA showed the presence of extremely small aneurysms of the basilar truncus artiriosus. The angiography of the aneurysms is shown in FIG. 5A. After the Solitaire stent releaser is powered on 3 times for 6 minutes in total, the tumor cavity is not developed obviously. As shown in FIG. 5B, it indicates that the electric thrombus is also well formed.

[0057] The above-mentioned examples are only used to illustrate or explain the technical scheme of the application, and should not be construed as constituting any limitation to the application. Any improvement and modification of this application without creative labor shall also be deemed to fall within the scope of this application.