Integrated apparatus for cerebral tissue biopsy or electrode placement by means of venous intervention via superficial cerebral vein

Abstract

The present invention relates to an integrated apparatus for cerebral tissue biopsy or electrode placement by means of venous intervention via a superficial cerebral vein. The integrated apparatus comprises a catheter and a variable balloon. The catheter is connected to the proximal end of the balloon. At least three channels are formed in the catheter: a balloon filling channel, a guide channel, and a working channel. The balloon filling channel is in communication with an inner cavity of the balloon so as to inject a contrast agent into the balloon to expand the balloon. The guide channel penetrates through the inner cavity of the balloon from the proximal end of the balloon and exits from the distal end of the balloon to be sleeved with a microguide wire. The working channel extends out of a side wall of the catheter at a set distance from the proximal end of the balloon. The working channel is provided with a puncture needle in a penetrating manner. The puncture needle protrudes from the exit port of the working channel and is used for biopsy sampling of superficial or deep brain tissue or electrode placement. The integrated apparatus has rich functions, which can not only be used for biopsy, but also can be used for electrode placement, and has accurate positioning, simple operation, high success rate, and little environmental influence in the working process.

Description

Intravenous intervention for brain tissue biopsy or electrode placement through the superficial cerebral vein Technical Field

[0001] The present invention relates to the field of medical devices, and in particular to an integrated device for intravenous intervention to perform brain tissue biopsy or electrode placement via cerebral superficial veins. Background Art

[0002] Currently, brain tissue biopsy, or placement of electrodes on the brain surface or deep within the brain, is performed by craniotomy or drilling. Traditional methods cause severe damage to the body and brain tissue, are prone to bleeding, cause significant pain to the patient, are complex to operate, have poor positioning accuracy, and are prone to deviations in biopsy sampling or electrode placement. Technical issues

[0003] The purpose of the present invention is to provide an integrated device for intravenous intervention through the superficial cerebral vein to perform brain tissue biopsy or electrode placement. The integrated device is rich in functions and can be used for both biopsy and electrode placement. It has accurate positioning, simple operation, high success rate, and the working process is less affected by the environment. Technical Solutions

[0004] In order to achieve the above-mentioned purpose, the technical solution adopted by the present invention is: an integrated device for intravenous intervention to perform brain tissue biopsy or electrode placement through the surface vein of the brain, including a catheter and a changeable balloon, the catheter is connected to the proximal end of the balloon, and the catheter has at least three channels: a balloon filling channel, a guide channel and a working channel. The balloon filling channel is connected to the inner cavity of the balloon to fill the balloon with contrast agent to expand it. The guide channel passes through the inner cavity of the balloon from the proximal end of the balloon and exits from the distal end of the balloon, and is used to sheath a microguidewire. The working channel extends from the side wall of the catheter at a set distance from the proximal end of the balloon. A puncture needle is arranged in the working channel, and the puncture needle exits from the protruding end of the working channel, and is used for surface or deep biopsy sampling of brain tissue or electrode placement.

[0005] Furthermore, the puncture needle has an internal channel and an opening at its front end, and the front end of the puncture needle punctures the target object; when used for biopsy sampling, the sampling hook is transported to the front end of the puncture needle through the internal channel, and samples are taken from the target object; when used for electrode placement, the electrode is transported to the front end of the puncture needle through the internal channel, and the electrode is placed in the target object.

[0006] Furthermore, the balloon and the catheter are sheathed on the micro-guidewire through the guide channel, and reach the target position under the guidance of the micro-guidewire during operation.

[0007] Furthermore, the catheter has a plurality of working channels, which extend from different sides of the catheter respectively, so that biopsy sampling or electrode placement can be selected from corresponding directions during operation.

[0008] Furthermore, except for the balloon filling channel being connected to the balloon lumen, the guide channel and the working channel are isolated from the balloon lumen.

[0009] Furthermore, the balloon filling channel, guide channel and working channel are integrated into one catheter, and various channels are separated at the proximal end of the catheter, which are respectively used to connect the contrast agent filling device, sheath the micro guidewire and insert the puncture needle.

[0010] Furthermore, the distal and proximal ends of the balloon and the protruding end of the working channel of the catheter are respectively provided with metal marks to facilitate positioning of the balloon and the puncture needle during operation.

[0011] Furthermore, the integrated device is equipped with a guide wire for sealing and repairing that can be transported in the working channel, the front end of the guide wire for sealing and repairing is provided with a fusible sealing head, and the front end of the sealing head is provided with an umbrella-shaped biofilm made of body-absorbable material and self-expandable; when the guide wire for sealing and repairing is transported in the working channel, the umbrella-shaped biofilm is constrained by the working channel and retracted to the outer periphery of the sealing head, and when the umbrella-shaped biofilm passes through the working channel, it automatically opens forward and outward.

[0012] Furthermore, the integrated device is equipped with a sealing and repairing guide wire that can be transported in the working channel, and a fusible sealing head is provided at the front end of the sealing and repairing guide wire, and two umbrella-shaped biofilms made of body-absorbable material and self-expanding are provided at the front and rear ends of the sealing head in the positive and reverse directions; when the sealing and repairing guide wire is transported in the working channel, the two umbrella-shaped biofilms are constrained by the working channel to retract at the outer periphery of the front and rear ends of the sealing head, and when the umbrella-shaped biofilm at the front end passes through the working channel, it automatically opens to the front and outside, and when the umbrella-shaped biofilm at the rear end passes through the working channel, it automatically opens to the rear and outside.

[0013] Furthermore, the working channel is also used to transport and eject venous wall repair material to seal and repair the puncture wound of the object. The venous wall repair material is made of a biological material that is sticky to the venous wall and can be absorbed by the venous wall. Beneficial effects

[0014] Compared with the existing technology, the present invention has the following advantages: the present invention integrates the balloon, catheter, biopsy device, and electrode placement device into an integrated device. This integrated device has a multi-channel design, wherein the working channel can be used for biopsy and for placing various electrodes such as human-machine dialogue electrodes, brain pacing electrodes, nerve regulation electrodes, and brain function localization electrodes. The balloon filling channel is connected to the balloon, and by expanding the balloon, venous blood flow is reversely blocked, thereby ensuring that the working position is not affected by blood flow, achieving the advantages of minimal trauma, convenience, accurate positioning, and easy placement. Therefore, the present invention has strong practicality and broad application prospects. BRIEF DESCRIPTION OF THE DRAWINGS

[0015] FIG1 is a schematic structural diagram of an integrated device according to an embodiment of the present invention;

[0016] FIG2 is a schematic diagram of a first working state of the integrated device according to an embodiment of the present invention;

[0017] FIG3 is a schematic diagram of a second working state of the integrated device according to an embodiment of the present invention;

[0018] FIG4 is a partially enlarged schematic diagram of the puncture needle in FIG2 ;

[0019] FIG5 is a schematic diagram of a working state of a puncture needle for electrode placement according to an embodiment of the present invention;

[0020] FIG6 is a schematic diagram of a first working state of the guide wire for occlusion repair in Example 1 of the present invention;

[0021] 7 is a schematic diagram of a second working state of the occlusion repair guide wire in Example 1 of the present invention;

[0022] FIG8 is a schematic diagram of the third working state of the guide wire for occlusion repair in Example 1 of the present invention;

[0023] 9 is a schematic diagram of a fourth working state of the occlusion repair guidewire in Example 1 of the present invention;

[0024] 10 is a schematic diagram of the fifth working state of the occlusion repair guidewire in Example 1 of the present invention;

[0025] 11 is a schematic diagram of a first working state of the occlusion repair guidewire in the second embodiment of the present invention;

[0026] 12 is a schematic diagram of a second working state of the occlusion repair guide wire in the second embodiment of the present invention;

[0027] 13 is a schematic diagram of a third working state of the occlusion repair guidewire in the second embodiment of the present invention;

[0028] 14 is a schematic diagram of the fourth working state of the occlusion repair guidewire in the second embodiment of the present invention;

[0029] 15 is a schematic diagram of the fifth working state of the occlusion repair guidewire in the second embodiment of the present invention;

[0030] FIG16 is a schematic diagram of the sixth working state of the guide wire for occlusion repair in the second embodiment of the present invention. Modes for Carrying Out the Invention

[0031] The present invention will be further described below with reference to the accompanying drawings and embodiments.

[0032] It should be noted that the following detailed descriptions are exemplary and are intended to provide further explanation of the present application. Unless otherwise specified, all technical and scientific terms used herein have the same meaning as commonly understood by those skilled in the art to which the present application belongs.

[0033] It should be noted that the terms used herein are only for describing specific embodiments and are not intended to limit the exemplary embodiments according to the present application. As used herein, unless the context clearly indicates otherwise, the singular form is also intended to include the plural form. In addition, it should be understood that when the terms "comprise" and / or "include" are used in this specification, they indicate the presence of features, steps, operations, devices, components and / or combinations thereof.

[0034] As shown in Figures 1-3, this embodiment provides an integrated device for intravenous intervention to perform brain tissue biopsy or electrode placement through the surface vein of the brain, including a catheter 1 and a variable balloon 2. The catheter 1 is connected to the proximal end of the balloon 2, and the catheter 1 has at least three channels: a balloon filling channel 101, a guide channel 102 and a working channel 103. The balloon filling channel 101 is connected to the inner cavity of the balloon to fill the balloon with contrast agent to expand it. The guide channel 102 passes through the inner cavity of the balloon from the proximal end of the balloon and exits from the distal end of the balloon, and is used to sheath a microguidewire 3. The working channel 103 extends from the side wall of the catheter at a set distance from the proximal end of the balloon. A puncture needle 4 is arranged in the working channel, and the puncture needle 4 exits from the protruding end of the working channel 103, and is used for surface or deep biopsy sampling of brain tissue or electrode placement.

[0035] For biopsy sampling or electrode placement, as shown in Figure 4 , the puncture needle 4 has an internal channel 401 and an opening 402 at its front end. The front end of the puncture needle is inserted into the target object 5. For biopsy sampling, the sampling hook is conveyed through the internal channel to the front end of the puncture needle, and a sample is taken from the target object. For electrode placement, as shown in Figure 5 , the electrode 10 is conveyed along the internal channel to the front end of the puncture needle via a guide wire 11, and the electrode is then placed into the target object.

[0036] The balloon 2 and the catheter 1 are sheathed on the micro guide wire 3 through the guide channel, and when working, they are guided by the micro guide wire 3 to reach the target position of the blood vessel 6, that is, the position where biopsy sampling or electrode placement is to be performed.

[0037] In this integrated device, except for the balloon filling channel 101, which is connected to the inner lumen of balloon 2, the guide channel 102 and working channel 103 are isolated from the inner lumen of balloon 2 and balloon filling channel 101. That is, when the guide channel 102 passes through the balloon, the connection between the channel and the balloon is sealed, while the working channel 103 does not penetrate the balloon, thus ensuring that each channel can operate independently without affecting each other. The balloon filling channel 101, guide channel 102, and working channel 103 are integrated into a single catheter 1. The distal end of the catheter 1 is connected to the proximal end of the balloon 2. The proximal end of the catheter 1 is separated into various channels, respectively used to connect to the contrast agent filling device, the sheathing of the microguidewire 3, and the insertion of the puncture needle 4.

[0038] In this embodiment, metal markers 7, 8, and 9 are provided on the distal and proximal ends of the balloon 2 and the protruding end of the working channel 103 of the catheter 1, respectively, to facilitate positioning of the balloon 2 and the puncture needle 4 during operation.

[0039] In order to avoid the need to adjust the insertion direction of the puncture needle during operation, or to facilitate biopsy sampling or electrode placement in different directions, in a preferred embodiment of the present invention, the catheter is provided with several working channels, and the several working channels extend from different sides of the catheter respectively, so that biopsy sampling or electrode placement can be selected from the corresponding direction during operation.

[0040] The method of using the integrated device for intravenous interventional brain tissue biopsy or electrode placement via the cerebral superficial vein provided in this embodiment is as follows:

[0041] 1) Place the balloon and catheter over the microguidewire through the guide channel.

[0042] 2) Continue to deliver the balloon and catheter distally until they reach the target position under the guidance of the microguidewire.

[0043] 3) Adjust the direction of the extended end of the working channel so that it faces the target object.

[0044] 4) Contrast agent is injected into the balloon through the balloon filling channel to expand the balloon and block the blood vessel, preventing blood flow from affecting biopsy sampling or electrode placement.

[0045] 5) Pass the puncture needle to the extended end of the working channel, then pass it through the extended end of the working channel and into the target object. If a biopsy is to be performed, pass the sampling hook through the internal channel of the puncture needle to the front end of the puncture needle and obtain a sample from the target object. If an electrode is to be placed, pass the electrode through the internal channel of the puncture needle to the front end of the puncture needle and place the electrode into the target object.

[0046] The integrated device for intravenous intervention for brain tissue biopsy or electrode placement via the surface vein of the brain of the present invention also provides multiple implementation schemes for repairing the puncture object rupture (venous wall) after completing the work task.

[0047] In one embodiment of the present invention, the integrated device is equipped with a guide wire 12 for blocking and repairing that can be transported in the working channel. The front end of the guide wire 12 for blocking and repairing is provided with a fusible blocking head 13, and the front end of the blocking head 13 is provided with an umbrella-shaped biofilm 14 made of body-absorbable material and self-expandable; when the guide wire 12 for blocking and repairing is transported in the working channel, the umbrella-shaped biofilm is constrained by the working channel and retracted to the outer periphery of the blocking head, and when the umbrella-shaped biofilm passes through the working channel, it automatically opens forward and outward.

[0048] In this embodiment, when the biopsy or electrode placement task is completed, the puncture needle is retracted, and the occlusion and repair guide wire is transported through the working channel toward the protruding end of the working channel, as shown in Figure 6. During the transportation process, the umbrella-shaped biofilm is restricted by the working channel and retracted to the outer periphery of the occlusion head, as shown in Figures 6-7. When the occlusion head passes through the working channel, as shown in Figure 8, the umbrella-shaped biofilm is no longer restricted by the working channel and automatically opens. At this time, the occlusion and repair guide wire is pulled back to allow the umbrella-shaped biofilm to adhere to the outer wall of the puncture object's rupture, as shown in Figure 9. Then, the occlusion head is melted, and the occlusion head and the umbrella-shaped biofilm are integrated to block the puncture object's rupture, and the remaining part of the occlusion and repair guide wire continues to be retracted, as shown in Figure 10. At this time, the contrast agent can be withdrawn, the airbag can be deflated, and blood flow can be restored.

[0049] In another embodiment of the present invention, the integrated device is equipped with a sealing and repairing guide wire 15 that can be transported in the working channel. The front end of the sealing and repairing guide wire 15 is provided with a fusible sealing head 16, and the front and rear ends of the sealing head 16 are provided with two umbrella-shaped biofilms 17 and 18 made of body-absorbable material and self-expandable in positive and negative directions; when the sealing and repairing guide wire is transported in the working channel, the two umbrella-shaped biofilms are constrained by the working channel to retract at the outer periphery of the front and rear ends of the sealing head, and when the umbrella-shaped biofilm at the front end passes through the working channel, it automatically opens forward and outward, and when the umbrella-shaped biofilm at the rear end passes through the working channel, it automatically opens backward and outward.

[0050] In this embodiment, after the biopsy or electrode placement task is completed, the puncture needle is retracted and a closure and repair guidewire is transported through the working channel toward the protruding end of the working channel, as shown in Figure 11. During the transport process, the umbrella-shaped biofilm is restricted by the working channel and retracts to the outer periphery of the closure head, as shown in Figures 11-12. When the closure head passes through the working channel, as shown in Figure 13, the front umbrella-shaped biofilm is no longer restricted by the working channel and automatically opens, that is, opens forward and outward. At this time, the closure and repair guidewire is pulled back to allow the front umbrella-shaped biofilm to adhere to the outer wall of the puncture target. The working channel is then slightly withdrawn to allow the rear umbrella-shaped biofilm to pass through the working channel. At this time, the umbrella-shaped biofilm is no longer restricted by the working channel and automatically opens in the opposite direction, as shown in Figure 14. Then, the rear umbrella-shaped biofilm that has been opened in the opposite direction is pushed against the inner wall of the puncture target through the front end of the working channel, thereby sealing the inner and outer walls of the puncture target with a double layer of umbrella-shaped biofilm in both the forward and reverse directions, as shown in Figure 15. Then, the plugging head is melted and integrated with the forward and reverse double-layer umbrella-shaped biofilm to seal the puncture wound. The remaining part of the occlusion repair guidewire is further retracted, as shown in Figure 16. At this time, the contrast agent can be withdrawn, allowing the balloon to continue to deflate and restore blood flow.

[0051] In another embodiment of the present invention, the working channel can be used to deliver and eject a venous wall repair material to seal and repair the punctured object. The venous wall repair material is made of a biomaterial that is adherent to and absorbable by the vein wall. After completing its task, the puncture needle is retracted, and the venous wall repair material is then delivered through the working channel and ejected from the distal end of the working channel. The ejected venous wall repair material adheres to the punctured object, thereby repairing the damaged venous wall.

[0052] The above description is merely a preferred embodiment of the present invention and is not intended to limit the present invention in any other manner. Any person skilled in the art may utilize the above-disclosed technical content to modify or modify the present invention into equivalent embodiments. However, any simple modifications, equivalent variations, and modifications to the above embodiments that do not depart from the technical content of the present invention and are based on the technical essence of the present invention remain within the scope of protection of the present invention.

Claims

1. An integrated device for intravenous interventional brain tissue biopsy or electrode placement via the superficial cerebral vein, characterized in that: The invention comprises a catheter and a changeable balloon, wherein the catheter is connected to the proximal end of the balloon and has at least three channels therein: a balloon filling channel, a guide channel and a working channel. The balloon filling channel is connected to the inner cavity of the balloon so as to fill the balloon with contrast agent to expand it. The guide channel passes through the inner cavity of the balloon from the proximal end of the balloon and out from the distal end of the balloon and is used for sheathing a microguidewire. The working channel extends from the side wall of the catheter at a set distance from the proximal end of the balloon. A puncture needle is arranged in the working channel and extends from the protruding end of the working channel for biopsy sampling or electrode placement.

2. The integrated device for intravenous interventional brain tissue biopsy or electrode placement via cerebral superficial veins according to claim 1, characterized in that: The puncture needle has an internal channel and an opening at its front end, and the front end of the puncture needle punctures the target object; the puncture depth of the puncture needle can be deep or shallow as needed; when used for biopsy sampling, the sampling hook is conveyed to the front end of the puncture needle through the internal channel, and the sample is taken from the target object; when used for electrode placement, the electrode is conveyed to the front end of the puncture needle through the internal channel, and the electrode is placed in the target object.

3. The integrated device for intravenous interventional brain tissue biopsy or electrode placement via cerebral superficial veins according to claim 1, characterized in that: The balloon and the catheter are sleeved on the micro-guidewire through the guide channel, and reach the target position under the guidance of the micro-guidewire during operation.

4. The integrated device for intravenous interventional brain tissue biopsy or electrode placement via cerebral superficial veins according to claim 1, characterized in that: The catheter is provided with a plurality of working channels, which extend from different sides of the catheter respectively, so that biopsy sampling or electrode placement can be selected from corresponding directions during operation.

5. The integrated device for intravenous interventional brain tissue biopsy or electrode placement via cerebral superficial veins according to claim 1, characterized in that: Except that the balloon filling channel is connected to the balloon inner cavity, the guide channel and the working channel are isolated from the balloon inner cavity.

6. The integrated device for intravenous interventional brain tissue biopsy or electrode placement via cerebral superficial veins according to claim 1, characterized in that: The balloon filling channel, the guide channel and the working channel are integrated into one catheter, and the channels are separated at the proximal end of the catheter, which are respectively used for connecting the contrast agent filling device, sheathing the micro guide wire and inserting the puncture needle.

7. The integrated device for intravenous interventional brain tissue biopsy or electrode placement via cerebral superficial veins according to claim 1, characterized in that: The distal and proximal ends of the balloon and the protruding end of the working channel of the catheter are respectively provided with metal marks, so as to facilitate the positioning of the balloon and the puncture needle penetration position during operation.

8. The integrated device for intravenous interventional brain tissue biopsy or electrode placement via cerebral superficial veins according to claim 1, characterized in that: The integrated device is equipped with a guide wire for sealing and repairing that can be transported in the working channel. The front end of the guide wire for sealing and repairing is provided with a fusible sealing head, and the front end of the sealing head is provided with an umbrella-shaped biofilm made of body-absorbable material and self-expandable. When the guide wire for sealing and repairing is transported in the working channel, the umbrella-shaped biofilm is constrained by the working channel and retracted to the outer periphery of the sealing head. When the umbrella-shaped biofilm passes through the working channel, it automatically opens forward and outward.

9. The integrated device for intravenous interventional brain tissue biopsy or electrode placement via cerebral superficial veins according to claim 1, characterized in that: The integrated device is equipped with a sealing and repairing guide wire that can be transported in the working channel. A fusible sealing head is provided at the front end of the sealing and repairing guide wire, and two umbrella-shaped biofilms made of body-absorbable material and self-expanding are provided at the front and rear ends of the sealing head in the positive and reverse directions. When the sealing and repairing guide wire is transported in the working channel, the two umbrella-shaped biofilms are constrained by the working channel to retract at the outer periphery of the front and rear ends of the sealing head. When the umbrella-shaped biofilm at the front end passes through the working channel, it automatically opens to the front and outside. When the umbrella-shaped biofilm at the rear end passes through the working channel, it automatically opens to the rear and outside.

10. The integrated device for intravenous intervention through cerebral superficial veins for brain tissue biopsy or electrode placement according to claim 1, characterized in that: The working channel is also used to deliver and eject venous wall repair material to seal and repair the puncture wound of the object. The venous wall repair material is made of a biological material that is sticky to the venous wall and can be absorbed by the venous wall.

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