Interventional devices for tubular bodies

Abstract

An interventional device for a tubular body comprises: a stent, switchable between a first state and a second state, the diameter of the stent in the second state being larger than the diameter in the first state; at least one puncture portion provided on the stent, the puncture portion being used to puncture the wall of the tubular body when the stent is in the second state; and at least one electrode provided on the at least one puncture portion, the electrode being used to extend outside the tubular body from the area on the wall punctured by the puncture portion. Through the disclosed solution, effective implantation of electrodes can be achieved based on the interventional device, and the implanted electrodes can directly contact the target area of ​​biological tissue outside the tubular body, achieving direct and unobstructed signal interaction, greatly improving the effect of the electrodes in collecting signals and applying stimulation.

Description

Technical Field

[0001] The present invention relates to the technical field of medical instruments, and in particular to an interventional device for a tubular body. Background Art

[0002] In the field of medical devices, electrodes that sense brainwave signals (such as rigid electrodes and flexible electrodes) are widely researched and applied. The electrodes are placed close to the brain tissue (such as on the skull, above the dura mater, or below the dura mater) or implanted into the brain tissue.

[0003] Currently, the most common method for implanting electrodes in the brain involves first opening the scalp and skull to expose the brain tissue, then placing the electrodes on or into the brain tissue. This invasive implantation method, which requires opening the skull to expose brain tissue, can cause various adverse reactions and even threaten the health and safety of the individual.

[0004] Another way to sense EEG signals or stimulate brain tissue is through vascular access, which allows sensing and / or stimulation devices (e.g., electrodes) to be delivered to the target location through the body's natural pathways, such as blood vessels. While this approach enables non-invasive signal acquisition from brain tissue, the quality of the EEG signals collected by the implanted electrodes is poor and the quantity is very limited, affecting the signal acquisition effectiveness of the implanted electrodes. Summary of the Invention

[0005] The technical problem solved by the present invention is to provide an improved interventional device, which can realize effective signal sensing or electrical stimulation of the lesion area or target area while forming a minimal incision in tubular biological tissue, and can achieve a good electrode implantation effect.

[0006] To solve the above technical problems, an embodiment of the present invention provides an interventional device for a tubular body, comprising: a stent, which can be switched between a first state and a second state, and the diameter of the stent in the second state is larger than the diameter in the first state; at least one puncture portion, which is arranged on the stent, and the puncture portion is used to puncture the wall of the tubular body when the stent is in the second state; at least one electrode, which is arranged on the at least one puncture portion, and the electrode is used to extend out of the tubular body from the area on the wall punctured by the puncture portion.

[0007] Optionally, the stent is in a grid shape, and the at least one puncture portion is distributed at the intersection of the grid or the edge connecting adjacent intersections; and / or, the stent is in a corrugated shape, and the at least one puncture portion is distributed at different positions of the stent.

[0008] Optionally, the puncture portion can be switched between a non-upright state and an upright state, and the puncture portion in the upright state substantially extends along the radial direction of the stent.

[0009] Optionally, the puncture portion is elastically deformable between the non-upright state and the upright state; and / or, the puncture portion is made of nickel titanium.

[0010] Optionally, the length of the puncture portion in the upright state along the extension direction is greater than the thickness of the wall; and / or, there are multiple puncture portions, and the length of at least one puncture portion in the upright state along the extension direction is different from the length of other puncture portions in the upright state along the extension direction.

[0011] Optionally, the puncture portion is cone-shaped, or at least the end of the puncture portion away from the stent is in a needle tip structure.

[0012] Optionally, the puncture portion and the bracket are integrally formed, or the puncture portion is connected to the bracket via a medium, and the medium is selected from at least one of an adhesive and a solder.

[0013] Optionally, the at least one puncture portion corresponds to the at least one electrode one-to-one, or a single puncture portion corresponds to a plurality of electrodes.

[0014] Optionally, the electrode includes: a first electrode site, which is at least arranged at the tip of the puncture part.

[0015] Optionally, the first electrode site is formed by a metal layer covering the outer surface of the puncture portion.

[0016] Optionally, a portion of the outer surface of the metal layer is coated with an insulating layer.

[0017] Optionally, the interventional device further includes: an electrode wire, wherein the electrode wire is electrically connected to the first electrode site.

[0018] Optionally, the electrode wire and the first electrode site are electrically connected via a conductive glue.

[0019] Optionally, the electrode includes: an electrode wire, the electrode wire includes at least one second electrode site, and the puncture portion is suitable for carrying at least a portion of the electrode wire to extend out of the tubular body from the area on the wall punctured by the puncture portion.

[0020] Optionally, the electrode wire is provided with a hole portion, and the hole portion is sleeved on the tip of the puncture portion.

[0021] Optionally, the outer surface of the puncture portion is covered with an insulating layer and / or a degradable layer.

[0022] Optionally, after at least a portion of the electrode wire extends out of the tubular body from the area on the wall pierced by the puncture portion, the stent can return to the first state and be withdrawn from the tubular body.

[0023] Optionally, the electrode wire holes of the plurality of electrode wires are sleeved on the tip of the same puncture portion.

[0024] Optionally, the puncture portion has a cavity for accommodating the electrode wire, and the tip of the puncture portion is provided with an opening communicating with the cavity, and the electrode wire can extend out of the puncture portion from the opening.

[0025] Optionally, a through hole communicating with the cavity is provided at the connection between the puncture portion and the bracket for the electrode wire to pass through.

[0026] Optionally, the interventional device further includes: an electrode wire guide, housed in the cavity, and configured to guide the electrode wire to extend from the opening to outside the puncture portion.

[0027] Optionally, the electrode wire extends along the outer side and / or inner side of the stent to the puncture portion.

[0028] Optionally, the interventional device further includes: a fixing layer, and the portion of the electrode wire extending along the stent is sandwiched between the fixing layer and the stent.

[0029] Optionally, the interventional device further includes: a blocking portion, which at least surrounds the puncture portion and is arranged on the outer surface and / or inner surface of the stent, and is used to block the gap between the wall and the puncture portion.

[0030] Optionally, the sealing portion includes a coating layer.

[0031] Optionally, when the stent is in the first state, at least the tip of the puncture portion is farther away from the stent than the coating layer.

[0032] Optionally, the interventional device further comprises: a delivery sheath detachably sleeved on the stent in the first state, wherein the delivery sheath is used to keep the stent in the first state.

[0033] Optionally, the end portion of the delivery sheath close to the stent can be torn apart radially to expand into a two-dimensional plane.

[0034] Optionally, the interventional device further includes: a balloon, the stent is sleeved on the balloon, and the balloon is used to switch the stent from the first state to the second state.

[0035] Optionally, the tubular body includes a blood vessel.

[0036] Optionally, the material of the stent is selected from any one of the following or a combination of the following: the material of the stent is selected from any one of the following or a combination of the following: nickel, titanium, nickel-titanium alloy, cobalt, cobalt alloy, chromium, cobalt-chromium alloy, magnesium, magnesium alloy, zinc alloy, stainless steel.

[0037] Optionally, the material of the puncture portion is selected from any one of the following or a combination of the following: nickel, titanium, nickel-titanium alloy, cobalt, cobalt alloy, chromium, cobalt-chromium alloy, magnesium, magnesium alloy, zinc alloy, and stainless steel.

[0038] Optionally, the material of the second electrode site is selected from any one of the following or a combination of the following: gold, platinum, iridium, tungsten, magnesium, molybdenum, platinum-iridium alloy, titanium alloy, graphite, carbon nanotubes, polyethylenedioxythiophene PEDOT and its derivative polymers, poly(p-styrene sulfonic acid), polypyrrole, and iridium oxide.

[0039] Optionally, the material of the coating is selected from any one of the following or a combination of the following: cellulose, chitin, hyaluronic acid, collagen, gelatin, sodium alginate, polyurethane PU, polytetrafluoroethylene PTFE, expanded polytetrafluoroethylene E PTFE, polylactic acid PAL, left-handed polylactic acid PLLA, right-handed polylactic acid PDLLA, polyglycolic acid PGA, polycaprolactone PCL, polyamide PA, polyethylene terephthalate PET, polyether block polyamide PEBAX, high-density polyethylene HDPE, thermoplastic polyurethane elastomer TPU, polyimide PI, polydimethylsiloxane PDMS, polyparaxylene Parylene, epoxy resin, polyamideimide PAI, polylactic acid PHA, polylactic acid-glycolic acid copolymer PHAH, poly(p-phenylene ether) C, SU8, silicone and silicone rubber.

[0040] Optionally, the material of the metal layer is selected from any one of the following or a combination of the following: gold, platinum, iridium, tungsten, magnesium, molybdenum, platinum-iridium alloy, and titanium alloy.

[0041] Optionally, the material of the insulating layer is selected from any one of the following or a combination of the following: polyimide PI, polydimethylsiloxane PDMS, polyparaxylene Parylene, polyethylene terephthalate PET, epoxy resin, polyamideimide PAI, polylactic acid PHA, polylactic acid-hydroxyacetic acid copolymer PHAH, poly(p-phenylene ether) C, SU8, silicone and silicone rubber.

[0042] Optionally, the material of the degradable layer is selected from any one of the following or a combination of the following: polylactic acid PLA, a composite of polylactic acid PLGA, and magnesium alloy.

[0043] Compared with the prior art, the technical solution of the embodiment of the present invention has the following beneficial effects:

[0044] An embodiment of the present invention provides an interventional device for a tubular body, comprising: a stent, which can be switched between a first state and a second state, and the diameter of the stent in the second state is larger than the diameter in the first state; at least one puncture portion, which is arranged on the stent, and the puncture portion is used to puncture the wall of the tubular body when the stent is in the second state; at least one electrode, which is arranged on the at least one puncture portion, and the electrode is used to extend outside the tubular body from the area on the wall punctured by the puncture portion.

[0045] Compared to the existing electrodes implanted based on interventional devices, which are attached to the inner wall of the tubular body and interact with the target area through the wall of the tubular body, which seriously affects the effect of the electrode collecting signals and applying stimulation, this embodiment can achieve effective electrode implantation based on an interventional device for the tubular body, and the implanted electrode can directly contact the target area of ​​biological tissue outside the tubular body, achieving direct and unobstructed signal interaction, greatly improving the effect of the electrode collecting signals and applying stimulation. Specifically, at least one puncture part is added to the stent. As the stent is expanded in the tubular body, the puncture part punctures the wall of the tubular body to form a channel for the electrode to extend. Furthermore, the electrode is inserted into the biological body through the tubular body with the stent, and is implanted into the target area near the tubular body through the channel created by the puncture part. There is no longer any obstruction of the tubular wall between the electrode sent out of the tubular body and the target area, so that the electrode can directly collect the electrical signal of the target area or directly apply stimulation signals to the target area, and the electrode implantation effect is greatly improved.

[0046] Furthermore, in specific application scenarios of brain-computer interfaces, a neural interface can be established between brain tissue and the interventional device described in this embodiment, realizing a brain-machine interface. Electrodes provided on or carried by the puncture site can be used to collect brain wave signals or provide specific electrical signals for electrical stimulation of brain regions.

[0047] Furthermore, the electrode includes a first electrode site, disposed at least at the tip of the puncture portion. Thus, by disposing the electrode site at the tip of the puncture portion, the puncture portion punctures the wall of the tubular body while the electrode site at the tip is simultaneously implanted into the target area. Furthermore, the first electrode site is formed from a metal layer covering the outer surface of the puncture portion, thereby enabling the surface layer of the puncture portion to simultaneously perform both puncture and implant functions, allowing for a one-step electrode implantation as the stent expands.

[0048] Furthermore, the electrode includes: an electrode wire, the electrode wire includes at least one second electrode site, and the puncture portion is suitable for carrying at least a portion of the electrode wire from the area on the wall pierced by the puncture portion to extend outside the tubular body. Thus, the electrode wire is carried by the puncture portion so that the electrode wire can pass through the wall of the tubular body to reach the outside of the tubular body, thereby achieving direct contact with the target area. Furthermore, the electrode wire prepared by any existing process can be carried by the puncture portion to complete the implantation, which is beneficial to improving the compatibility of the interventional device described in this embodiment and improving the adaptability to various types of electrode wires. BRIEF DESCRIPTION OF THE DRAWINGS

[0049] Figure 1 is a schematic diagram of an interventional device for a tubular body according to a first embodiment of the present invention;

[0050] Figure 2 yes Figure 1 A schematic diagram of the middle bracket in a first state;

[0051] Figure 3 yes Figure 1 a schematic diagram of the middle bracket in the second state;

[0052] Figure 4 yes Figure 1 A schematic diagram of a variation of the middle bracket;

[0053] Figure 5 is a schematic cross-sectional view of a puncture portion according to a second embodiment of the present invention;

[0054] Figure 6 is a schematic cross-sectional view of a puncture portion according to a third embodiment of the present invention;

[0055] Figure 7 yes Figure 6 A partial enlarged view of the middle electrode wire;

[0056] Figure 8 is a schematic cross-sectional view of a puncture portion according to a fourth embodiment of the present invention;

[0057] Figure 9 yes Figure 8 A schematic cross-sectional view of a variation of the puncture portion shown;

[0058] Figure 10 is a schematic cross-sectional view of a puncture portion according to a fifth embodiment of the present invention;

[0059] Figure 11 is a schematic diagram of a delivery sheath according to a sixth embodiment of the present invention;

[0060] Figure 12 yes Figure 11 A partial enlarged view of the middle area A;

[0061] Figure 13 yes Figure 1 Cross-section along direction BB. DETAILED DESCRIPTION

[0062] As mentioned in the background art, the brainwave signals that can be collected by existing electrode implantation using vascular intervention are of poor quality and very limited in number.

[0063] The latest research result is a stentrode (stent electrode recording array) electrode, whose main working principle is: a disc-shaped electrode is placed on an intracranial stent, the intracranial stent is expanded in the blood vessel, and the disc-shaped electrode is attached to the inner wall of the blood vessel. The brain wave signal it senses is a mixed signal of many neurons in the brain tissue around the blood vessels.

[0064] This type of electrode implanted through vascular intervention can only collect brain signals across the blood vessel wall. There is a barrier of blood vessel wall and cerebrospinal fluid between the electrode patch located in the blood vessel and the neurons in the brain tissue near the blood vessel, resulting in the electrode patch not being able to directly collect and stimulate the signals of the neurons. The quality of the brain wave signals that can be collected by the electrode patch is poor and the number is very limited. The brain wave signals collected by the electrode patch are mixed signals of many neurons in the brain tissue around the blood vessels. The mixed signals of these neurons cannot characterize the signal characteristics of specific neurons, nor can they clearly characterize the functional characteristics of the brain region. It is also very difficult to distinguish the mixed signals of these neurons. At the same time, after analysis and decoding, these brain wave signals can only provide very little information for spinal lateral sclerosis (ALS) and can only be used for a small amount of behavioral control, such as moving and confirming the mouse cursor in conjunction with an eye movement device.

[0065] To solve the above technical problems, an embodiment of the present invention provides an interventional device for a tubular body, comprising: a stent, which can be switched between a first state and a second state, and the diameter of the stent in the second state is larger than the diameter in the first state; at least one puncture portion, which is arranged on the stent, and the puncture portion is used to puncture the wall of the tubular body when the stent is in the second state; at least one electrode, which is arranged on the at least one puncture portion, and the electrode is used to extend out of the tubular body from the area on the wall punctured by the puncture portion.

[0066] By adopting this embodiment, it is possible to achieve effective implantation of electrodes based on the interventional device, and the implanted electrodes can directly contact the target area of ​​biological tissue outside the tubular body, achieving direct and unobstructed signal interaction, greatly improving the effect of the electrodes collecting signals and applying stimulation. Specifically, at least one puncture portion is added to the stent, and as the stent expands within the tubular body, the puncture portion punctures the wall of the tubular body to form a channel for the electrode to extend. Furthermore, the electrode is introduced into the biological body through the tubular body along with the stent, and is implanted into the target area near the tubular body through the channel created by the puncture portion. There is no longer any obstruction of the wall of the tubular body between the electrode extending out of the tubular body through the channel and the target area, so that the electrode can directly collect electrical signals from the target area or directly apply stimulation signals to the target area, and the electrode implantation effect is greatly improved.

[0067] To make the above-mentioned objectives, features, and beneficial effects of the present invention more clearly understood, specific embodiments of the present invention are described in detail below with reference to the accompanying drawings. Identical parts are denoted by the same reference numerals in the various figures. The various embodiments are merely illustrative, and the structures shown in the various embodiments may be partially replaced or combined. In the variations, descriptions of matters identical to those in the first embodiment are omitted, and only the differences are described. In particular, identical effects produced by identical structures will not be discussed individually for each embodiment.

[0068] Figure 1 Schematic diagram of an interventional device 1 for a tubular body (hereinafter referred to as interventional device 1 ) according to a first embodiment of the present invention.

[0069] The interventional device 1 may include a device for sensing and / or stimulating tissue. For example, the interventional device 1 may be integrated with the device for sensing and / or stimulating tissue. In other words, the interventional device 1 described in this embodiment itself may be regarded as a device for sensing and / or stimulating tissue. For another example, the interventional device 1 may carry the device for sensing and / or stimulating tissue. After the device for sensing and / or stimulating tissue, such as an electrode, is implanted into the target area through the tubular body in an interventional manner, the interventional device 1 may be withdrawn from the tubular body, at which point the electrode is retained in the target area.

[0070] The tissue may be, for example, cells (eg, neurons) of an organism (eg, a brain).

[0071] The device for sensing and / or stimulating tissue may be, for example, an electrode. In some embodiments, the electrode may comprise a flexible electrode. The flexibility of the flexible electrode may be specifically reflected in the electrode being a flexible structure that can be bent / folded as needed. The definition of a flexible electrode may refer to the universal definition in the art.

[0072] The tubular body may be, for example, a blood vessel, a trachea, an esophagus, a renal tubule, a larynx, a catheter, or the like.

[0073] Based on this embodiment, the cells of the organism intervened by the interventional device 1 interact with the outside world through electrodes. The interventional device 1 can implant electrodes into a target area via the tubular body through an interventional method, so that the electrodes can sense and / or stimulate tissue in the target area. The target area is located outside the tubular body. The tissue surrounding the tubular body intervened by the interventional device 1 can be referred to as the target area.

[0074] Specifically, refer to Figures 1 to 3 The interventional device 1 for a tubular body according to this embodiment may include a stent 11, which may be in a first state (eg Figure 2 As shown) and the second state (as Figure 1 and 3 The diameter of the bracket 11 when in the second state is greater than the diameter when in the first state.

[0075] The support 11 may also be referred to as a support frame. For example, the support 11 may have at least a contracted state (e.g., Figure 2 the first state shown), a released state, and an expanded state (e.g., Figure 1 and Figure 3 In some embodiments, the stent 11 can be restrained in a contracted state by an external force, and enters a released state as the external force is removed, and further enters an expanded state as the stent 11 deforms and / or is acted upon by another external force. The external force can, for example, come from a delivery sheath 3 (e.g., Figure 11 As shown), another external force may come from, for example, the balloon 12 (refer to the balloon stent in the prior art). In a specific embodiment, the stent 11 may be an annular structure as a whole, such as an annular wave-shaped structure.

[0076] For ease of description, the radial direction of stent 11 is designated as the r direction, and the axial direction of stent 11 is designated as the x direction. Stent 11 has radially opposed inner and outer surfaces 11a and 11b. The inner side of inner surface 11a faces the balloon 12, while the outer side of outer surface 11b faces the wall of the tubular body.

[0077] Further, continue to refer to Figures 1 to 3 The interventional device 1 may further include at least one puncture portion 2 provided on the stent 11 , and the puncture portion 2 may be used to puncture the wall of the tubular body when the stent 11 is in the second state.

[0078] For example, the puncture portion 2 can be fixed to the outer surface 11b of the stent 11 and extend outward substantially in the radial direction (e.g., direction r) at least when the stent 11 is in the second state. Furthermore, the end of the puncture portion 2 away from the stent 11 is a pointed end 2a to ensure reliable puncture of the wall of the tubular body.

[0079] For another example, multiple puncture portions 2 can be distributed at different positions of the stent 11, which is beneficial for increasing the contact points with the wall of the tubular body.

[0080] Furthermore, the interventional device 1 may further include at least one electrode 13 disposed at at least one puncture portion 2, the electrode 13 being configured to extend outside the tubular body from the area of ​​the wall punctured by the puncture portion 2. The electrode 13 is the portion of the corresponding puncture portion 2 used to establish a neural interface.

[0081] Furthermore, the electrode 13 extending out of the tubular body from the area punctured by the puncture portion 2 reaches the target area (eg, brain tissue) near the periphery of the tubular body, thereby establishing a direct connection with, for example, neurons in the brain.

[0082] Furthermore, each electrode 13 has a corresponding electrode wire 14. Figure 1 One of the electrode wires 14 is shown as an example. In some embodiments, each electrode wire 14 corresponds to at least one electrode 13. For example, the electrode wires 14 and the electrodes 13 correspond one to one.

[0083] Furthermore, the interventional device 1 may also include a balloon 12, over which the stent 11 is sheathed. The balloon 12 is used to switch the stent 11 from a first state to a second state. For example, the balloon 12 and the stent 11 sheathed thereon may be collectively referred to as a balloon-stent. The balloon-stent has at least a contracted state, a released state, and an expanded state. As an implant, the balloon-stent can be moved along the tubular lumen to a target location.

[0084] In a typical application scenario, the balloon stent in a contracted state is delivered to the target location by intervention, and then the balloon stent is released and gas or liquid is filled into the balloon 12 to open the stent 11, so that the stent 11 enters the expanded state, such as Figure 1 Under the action of the expansion force, the puncture portion 2 on the stent 11 can puncture the wall of the tubular body, and the tip 2a of the puncture portion 2 can extend out of the tubular body, thereby implanting the electrode 13 into the target area near the periphery of the tubular body.

[0085] In some embodiments, the stent 11 has a tubular shape that matches the shape of a blood vessel in the axial direction (e.g., the x-direction). Due to the material properties of the metal used, the stent 11 has self-supporting properties and is contractible in both the axial direction (e.g., the x-direction) and the radial direction (e.g., the r-direction).

[0086] In some embodiments, the bracket 11 can be made of an alloy with good elasticity, such as nickel titanium.

[0087] In some embodiments, the manufacturing method of the bracket 11 may include cutting, carving, metal weaving, etc.

[0088] In some embodiments, the stent 11 is in a released state after being released from the delivery sheath 3 that wraps it, and is subsequently in an expanded state after being expanded by the filled balloon 12. In the released state and the expanded state, the stent 11 has a lattice-like shape (e.g., Figure 1 and Figure 3 as shown) or corrugated (as Figure 4 As shown), the entire stent 11 presents a porous structure when viewed in its radial direction (as shown Figure 1 and Figure 3 as shown) or striped structures (as Figure 4 shown).

[0089] For example, if the tubular body is a blood vessel and the target area is brain tissue, the stent 11 is first delivered to the target location by the delivery sheath 3. Then, the delivery sheath 3 is withdrawn, releasing the stent 11 and exposing it to the blood vessel. At this point, the stent 11 is in a released state and has a certain degree of self-expansion.

[0090] Then, by filling the balloon 12 inside the stent 11 with gas or liquid, the stent 11 is further expanded and stretched. Under the dual effects of self-expansion and the expansion of the balloon 12, the stent 11 expands and opens, allowing the puncture portion 2 on the stent 11 to puncture the blood vessel and contact the brain tissue outside the blood vessel. This allows the electrode 13 provided at the puncture portion 2 to contact the brain tissue outside the blood vessel, thereby enabling EEG signals to be sensed or electrical stimulation to be provided. For example, the electrode 13 can be provided at the tip 2a of the puncture portion 2. For another example, the tip 2a of the puncture portion 2 can carry the electrode 13.

[0091] Therefore, a puncture portion 2 is provided on the bracket 11, and the puncture portion 2 can puncture a tubular body (for example, a blood vessel). An electrode 13 is provided on the puncture portion 2. After the puncture portion 2 punctures the tubular body, the electrode 13 can contact the target area outside the tubular body (for example, brain tissue), thereby being able to directly collect electrical signals (for example, electroencephalogram signals) from the target area or transmit stimulation signals to the target area.

[0092] In some embodiments, the number of puncture portions 2 provided on the stent 11 can be any number, for example, 1, 2, 4, 6, 8, 16, 20, 24, 36, 40, 60, 64, etc.

[0093] In one specific implementation, reference Figures 1 to 3The support 11 may be in a grid shape. Further, at least one puncture portion 2 may be provided at a fulcrum of the support 11 or at other locations that can provide support force. The fulcrum may be, for example, an intersection of the support frame.

[0094] For example, at least one puncture portion 2 may be distributed at an intersection of the grid or at an edge connecting adjacent intersections.

[0095] In some embodiments, the spacing between adjacent intersections of the grid-shaped bracket 11 in the first state may be smaller than the spacing between adjacent intersections of the grid-shaped bracket 11 in the second state.

[0096] In one variation, reference Figure 4 The stent 11 may be corrugated. Further, at least one puncture portion 2 may be distributed at different positions of the stent 11. For example, the crest, trough, or position between the crest and trough of the corrugation may be used to set the puncture portion 2. Figures 2 to 4 The electrode wires 14 connecting the electrodes 13 are not shown.

[0097] In one specific implementation, continue to refer to Figures 1 to 3 The puncture part 2 can be in a non-upright state (such as Figure 2 as shown) and upright (as Figure 3 and Figure 1 The puncture portion 2 in the upright state basically extends along the radial direction of the stent 11 (for example, the r direction).

[0098] Specifically, refer to Figure 2 , the non-upright state can be, for example, a lying position, that is, the angle between the extension direction of the puncture portion 2 (for example, the direction from the end connected to the bracket 11 to the tip 2a) and the axial direction of the bracket 11 is basically zero. The angle can specifically refer to the angle between the extension direction of the puncture portion 2 and the support surface that provides support for the puncture portion 2. It should be pointed out that in actual applications, the specific value of the angle in the non-upright state can be reasonably determined within the range of [0,90) degrees according to the specific shape of the tubular body (for example, the degree of curvature, the diameter, etc.), so as to facilitate the implantation of the interventional device 1 and avoid the tip 2a of the puncture portion 2 scratching the tubular body.

[0099] Further, the upright state may include an approximately upright state. As the support 11 enters the released state, the puncture portion 2 moves from Figure 2The non-upright state shown is transformed into an upright state or a near-upright state, thereby maximizing the support force of the stent 11 during the expansion of the stent 11. This facilitates the puncture portion 2 to pierce the wall of the tubular body under the support of the expansion force of the stent 11. It should be noted that in actual applications, the specific value of the angle in the upright state can be reasonably determined within the range of [0, 90) degrees based on the specific shape of the tubular body (e.g., the degree of curvature, diameter, etc.), to ensure that the tip 2a of the puncture portion 2 in the upright state can smoothly pierce the wall of the tubular body as the stent 11 expands.

[0100] In some embodiments, the puncture portion 2 can be made of a relatively elastic metal, such as nickel-titanium or an alloy thereof, to provide elasticity to the puncture portion 2. This allows the puncture portion 2 to have a certain degree of bending ability and also allows it to self-restore to an upright state. In other words, the puncture portion 2 can elastically deform between the non-upright state and the upright state.

[0101] Specifically, after the delivery sheath 3 (i.e., the entire cannula of the interventional device 1) encasing the stent 11 is withdrawn, the elasticity of the puncture portion 2 enables it to return to an upright or nearly upright position. At this point, the central axis of the puncture portion 2 forms a corresponding angle (e.g., preferably 90 degrees) with its support surface on the stent 11, allowing the puncture portion 2 to obtain support from the support surface on the stent 11 to perform subsequent tubular puncture.

[0102] In some embodiments, provided that the puncture portion 2 in the upright position is sufficient to puncture the wall of the tubular body, the switching of the puncture portion 2 between the non-upright position and the upright position may not be limited to elastic deformation. For example, the puncture portion 2 may be able to expand and contract in the radial direction (e.g., in the r direction) to switch between the non-upright position and the upright position.

[0103] In a typical application scenario, during delivery of interventional device 1 into a tubular biological tissue, such as a blood vessel, stent 11 and puncture portion 2 are retracted within delivery sheath 3. Upon reaching the target location, delivery sheath 3 is withdrawn, releasing stent 11 and puncture portion 2. At this point, puncture portion 2 can automatically open and return to its upright position.

[0104] In one embodiment, the length of the puncture portion 2 in the upright position is greater than the thickness of the tubular wall. This ensures that the puncture portion 2 can penetrate the wall in the upright position, allowing the electrode 13 to extend and reach the exterior of the tubular body. Furthermore, by rationally designing the length of the puncture portion 2, a sufficient amount of excess material remains after puncturing, for example, a blood vessel, thereby ensuring that the electrode 13 can effectively establish a direct electrical connection with the cranial nerve.

[0105] In some embodiments, the length of the puncture portion 2 along the extension direction can be determined according to the wall thickness of the tubular body into which the interventional device 1 needs to be implanted.

[0106] In a specific implementation, there are multiple puncture parts, and the length of at least one puncture part 2 along the extension direction in the upright state may be different from the length of other puncture parts 2 along the extension direction in the upright state.

[0107] For example, the puncture portions 2 provided at different areas on the periphery of the stent 11 may have different lengths in the upright state.

[0108] For another example, the puncture portions 2 of different lengths may be evenly distributed on the outer surface 11 b of the stent 11 in an interspersed manner.

[0109] Therefore, tubular bodies with different wall thicknesses can be compatible, so that the interventional device 1 can be adapted to different types of tubular bodies.

[0110] In some embodiments, for multiple puncture portions 2 having different lengths in the upright state, the lengths of the puncture portions 2 along the extension direction in the non-upright state may be the same, which may be beneficial for facilitating the delivery of the interventional device 1 within the tubular body.

[0111] In some embodiments, by rationally arranging the distribution of the plurality of puncture portions 2 on the stent 11 , it is possible to avoid collisions between adjacent puncture portions 2 and resulting damage when the stent 11 is in the first state.

[0112] Furthermore, when the bracket 11 is in the first position, adjacent puncture parts 2 can be stacked up and down.

[0113] In a specific implementation, the puncture portion 2 may be conical, such as Figures 5 to 9 For example, it can be a narrow and long cone-shaped structure. The cone tip is suitable for forming the tip 2a.

[0114] In a variation, at least the end of the puncture portion 2 away from the stent 11 is a needle tip structure, such as Figure 10 As shown, to form a tip 2a sufficient to pierce the wall of the tubular body.

[0115] In some embodiments, the puncture portion 2 can be made by etching or other processing techniques.

[0116] In one embodiment, the puncture portion 2 can be fixed to the support 11 by, for example, bonding, laser welding, or the like. Specifically, the puncture portion 2 can be connected to the support 11 via a medium selected from at least one of an adhesive and a solder (also referred to as a welding agent). The adhesive can be, for example, glue, such as medical glue. The welding agent can be, for example, a laser welder.

[0117] In one variation, the puncture portion 2 can be integrally formed with the stent 11. This helps improve the overall structural strength of the stent 11 and the puncture portion 2 disposed thereon. Furthermore, the stent 11 can better provide support for the puncture portion 2, ensuring that the puncture portion 2 quickly and reliably pierces the wall of the tubular body.

[0118] In a specific implementation, a single puncture portion 2 may correspond to at least one electrode 13 .

[0119] For example, at least one puncture portion 2 may correspond one to one with at least one electrode 13. That is, each puncture portion 2 is provided with or carries one electrode 13.

[0120] For another example, a single puncture part 2 can correspond to multiple electrodes 13. That is, a puncture part 2 can carry or be provided with multiple electrodes 13 at the same time, which helps to increase the number of electrodes 13 that can establish direct connection with the target area after the puncture part 2 punctures the wall of the tubular body.

[0121] In some embodiments, a single puncture portion 2 may be provided with multiple tips 2a.

[0122] For example, reference Figure 10 , a single puncture portion 2 may include multiple needle tip structures, each of which may carry one or more electrodes 13 (e.g., electrode wire 132). Multiple needle tip structures may be arranged in an array on a base 27, which may be fixed to the outer surface 11b of the bracket 11. The needle tip structure may be hollow and connected to the internal hollow area at the tip 2a, and the tip 2a may be designed with an inclined surface to ensure that it can puncture the wall of the tubular body. Alternatively, the needle tip structure may be solid, and the tip 2a may be provided with a hole 134 for the electrode wire 132 to carry the electrode 13 on the needle tip structure.

[0123] For another example, a single puncture portion 2 may include multiple cone-shaped structures, one of which is the main body and presents a tree-like branching structure. Each cone-shaped structure may carry or be provided with an electrode 13.

[0124] In one specific implementation, reference Figure 5 The electrode 13 may include a first electrode site 131, which is at least provided at the tip 2a of the puncture portion 2. In this embodiment, different functional structures are exemplarily distinguished by different types of filling in each exemplary cross-sectional view.

[0125] Specifically, the tip 2a may be, for example, the end of the puncture portion 2 that is away from the stent 11 in the upright state.

[0126] Furthermore, each first electrode site 131 may be adapted to form an electrode 13, and a first electrode site 131 is provided at each tip 2a of each puncture portion 2. In other words, the first electrode sites 131 and the tips 2a correspond one to one.

[0127] In an application scenario where the target area around the tubular body is brain tissue, the first electrode site 131 can be used to sense EEG signals or apply electrical stimulation to the brain tissue.

[0128] Thus, by disposing the electrode sites at the tip 2a of the puncture portion 2, the electrode sites at the tip 2a are implanted into the target area simultaneously with the puncture portion 2 puncturing the wall of the tubular body.

[0129] In some embodiments, the tip 2 a itself can form the first electrode site 131 . For example, the entire puncture portion 2 or at least the tip 2 a is made of a conductive material to form the first electrode site 131 .

[0130] In some embodiments, the first electrode site 131 may be formed by a metal layer 21 covering the outer surface of the puncture portion 2 .

[0131] Specifically, the upper surface of the puncture portion 2 (including the tip 2a) may have a metal coating (eg, a metal layer 21). The additionally coated metal layer 21 is beneficial for improving the electrical conductivity of the surface of the puncture portion 2.

[0132] In some embodiments, the material of the metal layer may be, for example, any one of gold, platinum, iridium, tungsten, magnesium, molybdenum, platinum-iridium alloy, titanium alloy, or a combination thereof.

[0133] Thus, the surface layer of the puncture portion 2 can simultaneously realize the puncture implantation function and the site signal collection function. As the stent 11 is expanded, the implantation of the electrode 13 can be completed in one step.

[0134] Furthermore, the material selection for the puncture portion 2 itself is more flexible and is not limited to conductive materials. For example, the material selection for the puncture portion 2 can be based on factors such as elasticity and hardness in the upright position. This helps reduce costs and allows for a harder puncture portion 2 to ensure reliable puncture. Furthermore, nickel titanium can be used to make the puncture portion 2, balancing elasticity and conductivity. Furthermore, the outer surface of the puncture portion 2 can be coated with a metal layer 21 made of a material such as tungsten or gold to further enhance conductivity.

[0135] In one specific implementation, continue to refer to Figure 5 , a portion of the outer surface of the metal layer 21 may be coated with an insulating layer 22 .

[0136] Specifically, the outer surface of the metal layer 21 except at the tip 2 a may be coated with the insulating layer 22 .

[0137] Furthermore, the insulating layer 22 can protect the metal layer 21 from being scratched, and can help ensure the insulation between the area of ​​the puncture part 2 except the electrode site 131 and the surrounding environment and other puncture parts 2.

[0138] In some embodiments, the material of the insulating layer 22 can be selected from any one of the following or a combination of the following: polyimide PI, polydimethylsiloxane PDMS, polyparaxylene Parylene, polyethylene terephthalate PET, epoxy resin, polyamideimide PAI, polylactic acid PHA, polylactic acid-glycolic acid copolymer PHAH, poly(p-phenylene ether) C, SU8, silicone and silicone rubber.

[0139] In some embodiments, the size of the area of ​​the metal layer 21 exposed outside the insulating layer 22 is suitable for ensuring that after the tip 2a pierces the wall of the tubular body, the exposed area can reliably electrically connect with cells at the target location.

[0140] In some embodiments, when the puncture portion 2 is in a non-upright state, the metal layer 21 and the insulating layer 22 attached to the surface of the puncture portion 2 may also be in a deformed state.

[0141] In one specific implementation, continue to refer to Figure 5 , the electrode wire 14 can be electrically connected to the first electrode site 131.

[0142] Specifically, the electrode wires 14 can correspond one-to-one with the first electrode sites 131, and transmit signals between the corresponding first electrode sites 131 and the outside world (for example, a computing device) without interfering with each other.

[0143] For example, the puncture portion 2 is cone-shaped, one puncture portion 2 corresponds to one thorn, and the top of each thorn is provided with a first electrode site 131. Accordingly, each thorn is connected to an independent electrode wire 14.

[0144] Furthermore, the electrode wire 14 may include a wire core 141 and a wire sheath 142 covering the wire core 141. The wire core 141 may function as an electrical connection, and the wire sheath 142 may function as insulation, isolation, and protection.

[0145] In one specific implementation, reference Figure 5 The electrode wire 14 and the first electrode site 131 can be electrically connected through conductive glue.

[0146] Specifically, the conductive glue may be applied between the puncture portion 2 and the bracket 11 .

[0147] For example, the puncture portion 2 is coated with a conductive adhesive (such as conductive glue) at least at the bottom to form a conductive adhesive layer 23 between the bottom surface and the bracket 11. The conductive adhesive layer 23 is electrically connected not only to the metal layer 21 but also to the electrode wire 14.

[0148] Furthermore, the puncture portion 2 can be connected to the stent 11 via a conductive adhesive and a fixing adhesive. For example, the fixing adhesive layer 24, the conductive adhesive layer 23, and the puncture portion 2 can be stacked sequentially from the inside to the outside of the stent 11 in a radial direction (e.g., the r direction). In other words, the conductive adhesive is disposed between the puncture portion 2 and the fixing adhesive.

[0149] During preparation, a fixing adhesive can be first applied to the support 11 to form a fixing adhesive layer 24, and then a conductive adhesive can be applied to the fixing adhesive layer 24 to form a conductive adhesive layer 23. Finally, the puncture portion 2 is fixed to the conductive adhesive layer 23, and the conductive adhesive is connected to the electrode wire 14. In this way, the conductive adhesive can not only adhere the puncture portion 2 to the support 11 together with the fixing adhesive, but can also further transmit the EEG signals collected by the first electrode site 131 on the puncture portion 2 to the electrode wire 14 through the conductive adhesive layer 23, or transmit the stimulation signals transmitted by the electrode wire 14 to the first electrode site 131 on the tip 2a, thereby providing electrical stimulation to the brain tissue.

[0150] In some embodiments, the electrode wire 14 can be connected to the bottom or side of the puncture portion 2. For example, it can be connected to the conductive glue on the bottom or side of the puncture portion 2.

[0151] In some embodiments, the projected area of ​​the fixing adhesive layer 24 on the stent 11 can be larger than the projected area of ​​the conductive adhesive layer 23 on the stent 11. Furthermore, the insulating layer 22 can cover the portion of the fixing adhesive layer 24 that is not covered by the puncture portion 2 (including the metal layer 21 covering the puncture portion 2), the conductive adhesive layer 23, and the electrode wire 14.

[0152] In one variation, the conductive glue can be coated around the connection between the puncture portion 2 and the fixed adhesive layer 24 (i.e., the side of the puncture portion 2), and the end of the electrode wire 14 can be adhered to the area coated with the conductive glue to achieve electrical connection.

[0153] Specifically, the fixing adhesive layer 24 and the puncture portion 2 are sequentially stacked radially (e.g., in the r direction) from the inside out on the stent 11. Furthermore, a conductive adhesive is applied around the connection gap between the fixing adhesive layer 24 and the puncture portion 2 (with the metal layer 21 coated on its outer surface) to electrically connect the metal layer 21 and the electrode wire 14.

[0154] Furthermore, the insulating layer 22 may cover the outer surface of the metal layer 21 except the tip 2 a and the outer surface of the conductive adhesive.

[0155] In one specific implementation, reference Figures 6 to 10 Electrode 13 may include an electrode wire 132, which may include at least one second electrode site 133. Cells in the target area interact with the outside world via the electrode wire (e.g., the wiring within the electrode wire and the rear end portion 135) through the second electrode site 133. In some embodiments, the rear end portion 135 may be, for example, a signal processing device.

[0156] Specifically, the electrode wire 132 may be a flexible structure that can be bent / folded as needed. Further, the electrode wire 132 may be, for example, an ultra-flexible electrode wire having a size in the micron range.

[0157] Furthermore, at least one second electrode site 133 may be correspondingly provided at the end of the electrode wire 132 , wherein each second electrode site 133 and the rear end portion 135 are electrically connected via wiring within the electrode wire.

[0158] Furthermore, the puncture portion 2 may be adapted to carry at least a portion of the electrode wire 132 out of the tubular body from the area of ​​the wall of the tubular body punctured by the puncture portion 2 .

[0159] Thus, the electrode wire 132 is carried by the puncture portion 2, allowing the electrode wire 132 to pass through the wall of the tubular body and reach the outside of the tubular body, achieving direct contact with the target area. Furthermore, the electrode wire 132 produced using any existing process can be carried by the puncture portion 2 for implantation, which helps improve the compatibility of the interventional device 1 described in this embodiment and enhances its compatibility with various types of electrode wire 132.

[0160] In some embodiments, at least one second electrode site 133 may be spaced apart along the extension direction of the electrode wire 132. Each second electrode site 133 may independently establish direct electrical connection with cells in the target area.

[0161] In some embodiments, the electrode wire 132 may be fabricated using micro-electromechanical machining technology. Specifically, the electrode wire 132 may include a second electrode site 133 and a wire structure (eg, a wire inside the electrode wire).

[0162] The second electrode site 133 is an exposed metal site, also called an electrode contact.

[0163] The wire structure is suitable for forming an electrode wire 14, which is used to transmit the EEG signal sensed or collected by the second electrode site 133 to a back-end device (such as the back-end part 135), or to transmit the stimulation signal transmitted from the back-end device to brain tissue cells.

[0164] Furthermore, the second electrode sites 133 are usually made of low-resistance metals such as gold and platinum.

[0165] For example, reference Figure 7 The second electrode sites 133 correspond one-to-one with the electrode leads 14. The electrode leads 14 are used to transmit EEG signals sensed or collected by the corresponding second electrode sites 133, or to transmit stimulation signals transmitted from the back-end device to neurons in the brain tissue. Each electrode lead 14 is separated by insulating material.

[0166] Further, refer to Figure 6 and Figure 7 , along the extension direction, the electrode wire 132 may include a site segment 132a at the front end, a wire segment 132b located in the middle, and a rear end segment 132c located at the rear end. The site segment 132a is at least partially implanted into a target area (e.g., brain tissue) outside the tubular body to sense EEG signals or provide stimulation signals. The wire segment 132b is at least partially attached to the bracket 11 (e.g., the coating layer 151 covering the bracket 11) to fix the electrode wire 132, which helps in the stable transmission of the signal. The rear end segment 132c can be located outside the biological body.

[0167] In some embodiments, Figures 6 to 10 The puncture portion 2 of the embodiment shown and the above Figure 5 The main differences of the puncture portion 2 in the illustrated embodiment are: Figures 6 to 10 The puncture portion 2 of the embodiment shown may not play (or not mainly play) a conductive role, and electrical connection with biological tissue in the target area is achieved through the electrode wire 132 carried outside the tubular body by the tip 2a of the puncture portion 2.

[0168] In one specific implementation, reference Figure 6 、 Figure 7 and Figure 10 The electrode wire 132 can be carried outside the tubular body in the form of being sheathed on the puncture part 2.

[0169] Specifically, the puncture portion 2 can be fixedly connected to the bracket 11. For example, the connection can be fixed by bonding or welding, and the welding can be, for example, laser welding.

[0170] Furthermore, the wire electrode 132 may be provided with a hole portion 134 (also referred to as a wire hole).

[0171] For example, the hole portion 134 may be located at the front end of the electrode wire 132 . That is, the hole portion 134 may be closer to the end of the electrode wire 132 than to the at least one second electrode site 133 .

[0172] For another example, the hole portion 134 may be provided in the middle of a section where the at least one second electrode site 133 of the electrode wire 132 is located.

[0173] Furthermore, the hole portion 134 may be sleeved on the tip 2 a of the puncture portion 2 .

[0174] For example, the tip 2a of the tapered puncture portion 2 passes through the hole 134, thereby carrying the electrode wire 132 into the target area (eg, brain tissue) as the tip 2a punctures the wall of the tubular body and enters the target area outside the tubular body.

[0175] Furthermore, after the electrode wire 132 is implanted in a target area such as brain tissue, the second electrode site 133 on the electrode wire 132 can contact the neurons in the brain tissue, thereby directly acquiring EEG signals from the neurons and transmitting stimulation signals directly to the neurons. In this way, EEG signals from a specific brain region can be directly sensed or collected. The EEG signals are of better quality and less contaminated, facilitating subsequent signal processing and analysis, and even controlling external devices based on the EEG signals.

[0176] In some embodiments, the electrode wire 132 may also be connected to the tip 2 a by adhesion, so that the electrode wire 132 is implanted into the target area as the tip 2 a penetrates the target area.

[0177] As described above, using this embodiment, after the puncture portion 2 on the stent 11 carries the electrode wire 132 and is implanted into the target area, the second electrode site 133 on the electrode wire 132 can collect electrical signals from the target area or provide electrical stimulation to the target area.

[0178] Furthermore, after the electrode wire 132 is implanted, the stent 11 can remain on the inner wall of the tubular body and maintain the implanted state of the puncture part 2 .

[0179] Alternatively, the stent 11 and puncture portion 2 can be withdrawn from the tubular body, leaving only the electrode wire 132 in the target area. For example, after at least a portion of the electrode wire 132 extends out of the tubular body from the area of ​​the tubular body punctured by the puncture portion 2, the stent 11 can be returned to the first state and withdrawn from the tubular body.

[0180] In some embodiments, the outer surface of the puncture portion 2 may be covered with a coating 25. The coating 25 may form a protective layer on the surface of the puncture portion 2, and further reduce potential damage to the hole portion 134 by the metal tip 2a when the hole portion 134 is hooked on the tip 2a.

[0181] In some embodiments, the coating 25 may be, for example, an insulating layer 22. Figure 5 The difference between the puncture portion 2 described in the illustrated embodiment is that the insulating layer 22 in this example can completely cover the outer surface of the puncture portion 2 , that is, the tip 2 a of the puncture portion 2 is also covered with the insulating layer 22 .

[0182] In some embodiments, coating 25 can be, for example, a degradable layer. Specifically, the degradable layer can be composed of a degradable material, including polymers such as polylactic acid (PLA), polylactic acid (PLGA), and degradable metals such as magnesium alloys. Furthermore, after the electrode wire 132 is implanted in the target area, the degradable layer can further degrade, thereby reducing the risk of damage to the target area and facilitating separation of the puncture portion 2 and the electrode wire 132.

[0183] In some embodiments, the coating 25 may be, for example, an insulating layer 22 and a degradable layer. For example, the insulating layer 22 may cover the outer surface of the puncture portion 2, and the degradable layer may be further coated on the outer surface of the insulating layer 22.

[0184] In some embodiments, each puncture portion 2 may be equipped with one or more electrode wires 132. For example, the holes 134 of the multiple electrode wires 132 may be sleeved on the tip 2a of the same puncture portion 2.

[0185] In one specific implementation, reference Figure 8 and Figure 9 , the electrode wire 132 can be carried outside the tubular body in the form of being housed inside the puncture part 2. Figure 6 and Figure 10 The difference between the illustrated embodiment is that the electrode wire 132 of the interventional device 1 described in this embodiment does not contact the wall of the tubular body during the period when the puncture part 2 punctures the wall of the tubular body, but extends out of the tubular body through the inside of the stent 11 and the inside of the puncture part 2.

[0186] Specifically, the puncture part 2 may have a cavity 26 , and the cavity 26 is used to accommodate the electrode wire 132 .

[0187] Furthermore, the tip 2a of the puncture portion 2 is provided with an opening 261 communicating with the cavity 26, and the electrode wire 132 can extend from the opening 261 outside the puncture portion 2. Thus, as the tip 2a pierces the wall of the tubular body and enters the target area, the electrode wire 132 can follow the tip 2a and be implanted into the target area outside the tubular body.

[0188] In some embodiments, one or more electrode wires 132 may be housed in the cavity 26 of a single puncture portion 2 .

[0189] In some embodiments, the cross-section of the opening 261 at the tip 2a can be an inclined surface, that is, the cross-section may not be perpendicular to the radial direction (e.g., the r direction) of the stent 11. Thus, the tip 2a with the opening 261 is shaped like a needle tip. While puncturing the wall of the tubular body, the electrode wire 132 housed in the cavity 26 is transported from the opening 261 to the outside of the tip 2a in a manner similar to a needle injection, thereby achieving electrical connection with cells in the target area outside the tubular body.

[0190] In some embodiments, the bottom end of the puncture portion 2 can be fixed to the bracket 11 by bonding or welding.

[0191] In a specific implementation, a through hole 262 communicating with the cavity 26 may be provided at the connection between the puncture portion 2 and the support 11 for the electrode wire 132 to pass through.

[0192] Specifically, the connection point can be located at the bottom of the puncture portion 2, for example. Accordingly, the through hole 262 extends radially (e.g., in the r direction) to connect the cavity 26 and the interior of the stent 11, and the electrode wire 132 extends along the inner side of the stent 11 to the puncture portion 2. The inner side of the stent 11 can specifically refer to the side facing the balloon 12.

[0193] For example, a through hole 262 can be formed directly below the cavity 26 in the radial direction (e.g., in the r direction). The through hole 262 communicates with the cavity 26, thereby allowing the electrode wire 132 to extend from the stent 11 through the through hole 262 into the cavity 26 of the puncture portion 2. In other words, the wire segment 132b of the electrode wire 132 can extend along the inner surface 11a of the stent 11.

[0194] In one variation, the connection point can be located on the side of the puncture portion 2. For example, a hole can be opened on the side of the puncture portion 2 near the stent 11 to allow the electrode wire 132 to pass through. Accordingly, the through hole 262 extends along the axial direction of the stent 11 (e.g., the x-direction) to connect the cavity 26 and the outer surface 11b of the stent 11. The electrode wire 132 extends along the outside of the stent 11 to the puncture portion 2. The outside of the stent 11 can specifically refer to the side facing the wall of the tubular body.

[0195] In some embodiments, the wire electrode 132 can move relative to the support 11 .

[0196] Furthermore, at least when the stent 11 is in the first state, the front end of the electrode wire 132 (e.g., at least the site segment 132a) can abut against the inner wall of the cavity 26. After the tip 2a of the puncture portion 2 pierces the tubular body and enters the target area, the electrode wire 132 can extend from the cavity 26 through the opening 261 and be implanted in the target area.

[0197] In a specific implementation, the interventional device 1 may further include an electrode wire guide (not shown), which is accommodated in the cavity 26 . The electrode wire guide is used to guide the electrode wire 132 to extend from the opening 261 out of the puncture portion 2 .

[0198] In one specific implementation, continue to refer to Figure 5 and Figure 9The interventional device 1 may further include a fixing layer 15 , and the portion of the electrode wire 14 or the electrode wire 132 extending along the stent 11 is sandwiched between the fixing layer 15 and the stent 11 .

[0199] Specifically, the fixing layer 15 may be, for example, a coating layer 151 . The electrode wire 14 or the electrode wire 132 may extend between the stent 11 and the coating layer 151 .

[0200] Furthermore, the coating layer 151 may be attached to (eg, in close contact with) the outer surface 11 b and / or the inner surface 11 a of the stent 11 .

[0201] Before use (e.g., when the stent 11 is in the first state), the tip 2a of the puncture portion 2 pre-passes through the coating layer 151. That is, when the stent 11 is in the first state, at least the tip 2a of the puncture portion 2 is farther away from the stent 11 than the coating layer 151.

[0202] In a typical application scenario, when the stent 11 is in the delivery sheath 3, it is in an unreleased state (i.e., a contracted state), and the puncture portion 2 on the stent 11 is also in an unreleased state. At this stage, the puncture portion 2 has already passed through the coating layer 151.

[0203] In the unreleased state, the puncture part 2 can lie on the surface of the coating layer 151, and in the subsequent released state, the puncture part 2 changes from the lying state (for example, the non-upright state) to the upright state so as to obtain the supporting force of the puncture tubular body from the surface of the stent 11.

[0204] In some embodiments, the front end of the electrode wire 132 can have a certain margin that is not clamped between the fixing layer 15 and the bracket 11, so as to ensure that after the tip 2a pierces the wall of the tubular body, the front end of the electrode wire 132 can move further outside the tubular body relative to the tip 2a, ensuring successful implantation into the target area and establishing an electrical connection with the biological tissue in the area.

[0205] For example, the portion of the electrode wire 132 accommodated in the cavity 26 may be bent at least once to achieve a certain margin, and this portion of the electrode wire 132 may extend out of the tip 2a from the opening 261 after the tip 2a pierces the wall of the tubular body.

[0206] In one specific implementation, continue to refer to Figures 5 to 10 The interventional device 1 may further include a blocking portion 16 , which is disposed on the outer surface 11 b and / or the inner surface 11 a of the stent 11 at least surrounding the puncture portion 2 , and the blocking portion 16 is used to block the gap between the wall of the tubular body and the puncture portion 2 .

[0207] In one specific embodiment, the interventional device 1 may further include a sealing portion 16, which at least surrounds the puncture portion 2 and is arranged on the outer surface 11b and / or inner surface 11a of the stent 11. The sealing portion 16 is used to seal the gap between the wall of the tubular body and the puncture portion 2.

[0208] Specifically, the blocking portion 16 may include a coating layer 151 , which may be made of, for example, a medical coating material with high biocompatibility such as PTFE.

[0209] Furthermore, the coating layer 151 can be manufactured using various processing methods, including stretching and electrospinning. The upper surface of the coating layer 151 (e.g., the surface facing the wall of the tubular body) can have a high specific surface area (specific surface area refers to the total area per unit mass of a material), thereby achieving high adhesion to biological tissues.

[0210] The coating layer can seal and stop bleeding the wound on the tubular body after the puncture portion 2 punctures the tubular body and is implanted into the biological tissue of the target area, while allowing the stent 11 to quickly form endothelialization on the inner wall of the tubular body.

[0211] In some embodiments, the coating layer 151 may only be present in the area where each puncture portion 2 is located. For example, the coating layer 151 may surround the area where the bottom end of the puncture portion 2 is located, so as to specifically cover the tiny wound caused by the tip 2a of the puncture portion 2 puncturing the wall of the tubular body.

[0212] In some embodiments, the coating layer 151 may cover the entire inner surface 11 a and / or outer surface 11 b of the stent 11 .

[0213] In some embodiments, the coating layer 151 may be, for example, a single layer film, such as Figure 5 、 Figure 6 、 Figure 8 and Figure 10 shown.

[0214] In some embodiments, the coating layer 151 may also be a two-layer or multi-layer film. For example, Figure 9 The embodiment shown and Figure 8 The main difference of the embodiment shown is that Figure 9 The interventional device 1 shown is provided with coating layers 151 on the inner surface 11 a and the outer surface 11 b of the stent 11 , respectively.

[0215] Specifically, the puncture portion 2 is pre-pierced through the coating layer 151 located on the outer surface 11b of the stent 11. The coating layer 151 located on the outer surface 11b of the stent 11 can block the tiny wound generated when the tip 2a punctures the wall of the tubular body.

[0216] Furthermore, the coating layer 151 located on the inner surface 11a of the stent 11 can be used to close the through hole 262 of the stent 11 on the tubular body side to prevent the liquid in the tubular body (for example, the blood in the blood vessel) from entering the cavity 26 of the puncture part 2 through the through hole 262, and then flowing out of the tubular body through the opening 261 of the puncture part 2 to cause internal bleeding.

[0217] Furthermore, the electrode unit including the electrode wire 132 and the electrode wire guide can be pre-extended between the bracket 11 and the coating layer 151 located on the inner surface 11a of the bracket 11, and pass through the through hole 262 into the cavity 26. In this way, the electrode unit can be fixed between the bracket 11 and the coating layer 151. In this case, the coating layer 151 located on the inner surface 11a of the bracket 11 can function as the aforementioned fixing layer 15.

[0218] Furthermore, in the example where the tubular body is a blood vessel, regardless of whether the blood vessel is a vein or an artery, the coating layer 151 located on the inner surface 11a of the stent 11 can provide a good sealing effect and provide a certain pressure to the electrode unit on the blood vessel side, thereby facilitating the fixation of the electrode unit between the stent 11 and the coating layer 151, and facilitating the subsequent implantation of the electrode unit.

[0219] In some embodiments, the sealing portion 16 may also be made of other hemostatic materials.

[0220] In some embodiments, along the radial direction of the stent 11 (eg, r direction), the stent 11 may be located between the coating layer 151 and the electrode wire 132 (or the electrode wire 14), as shown in FIG. Figure 8 shown.

[0221] In some embodiments, along the radial direction (eg, r direction) of the stent 11, the coating layer 151 may be located between the stent 11 and the electrode wire 132 (or the electrode wire 14). Figure 6 shown.

[0222] In one specific implementation, reference Figure 11 and Figure 12 The interventional device 1 may further include a delivery sheath 3 for delivering the balloon stent to the target position of the tubular body. The balloon stent may include a balloon 12 and a stent 11 sheathed on the balloon 12.

[0223] Specifically, the delivery sheath 3 can be detachably sleeved on the stent 11 in the first state to maintain the stent 11 in the first state.

[0224] Furthermore, the delivery sheath 3 can protect the balloon stent with the puncture portion 2 from being damaged during the delivery process. Furthermore, the delivery sheath 3 can overcome the resistance within the tubular body to smoothly deliver the balloon stent structure to the target location.

[0225] Furthermore, the balloon 12 and stent 11 of the balloon stent are radially stacked, that is, they form a concentric circular structure, and the stent 11 surrounds the balloon 12 in the radial direction (e.g., the r direction). The inner diameter of the delivery sheath 3 can be equal to or greater than the outer diameter of the radially stacked balloon 12 and stent 11 in the deflated state.

[0226] Furthermore, the radially stacked balloon 12 and stent 11 may be pre-placed in the delivery sheath 3. For example, the delivery sheath 3 may have an inner cavity 31 for accommodating the balloon stent.

[0227] The inner lumen 31 may extend along the axial direction (eg, x-direction) of the stent 11 , and the delivery sheath 3 may have a uniform diameter.

[0228] Furthermore, the delivery sheath 3 may further include a sleeve section 32 and a delivery section 33, wherein the diameter of the sleeve section 32 is larger than the diameter of the delivery section 33. Along the x-direction, the sleeve section 32 is provided at the front end to accommodate the main portion of the balloon-stent, such as the portion where the balloon 12 and the stent 11 are located. The delivery section 33 is provided at the rear end to accommodate the rear end portion of the balloon-stent, such as the portion of the catheter 17.

[0229] In some embodiments, the delivery sheath 3 may be, for example, a metal spring tube or a metal braided tube.

[0230] In some embodiments, the delivery sheath 3 may be coated with a polymer material.

[0231] In some embodiments, the softness of the delivery sheath 3 gradually decreases from the front end to the rear end.

[0232] In one specific implementation, continue to refer to Figure 11 and Figure 12 The end portion (eg, the front end) of the delivery sheath 3 close to the stent 11 can be torn apart in the radial direction (eg, the r direction) to be unfolded into a two-dimensional plane.

[0233] Specifically, the delivery sheath 3 has a tubular structure with a front end that can be torn and expanded, and the schematic diagram of the front end thereof is as follows: Figure 11 shown.

[0234] Furthermore, the tubular structure with a tearable and expandable front end can be opened and removed from the front end after the delivery sheath 3 is withdrawn, thereby avoiding damage to the electrode wire 14 and its rear end portion and the rear end portion of the balloon 12.

[0235] For example, the delivery sheath 3 is withdrawn to the rear end 17a of the catheter (eg Figure 1 When the forked structure is exemplarily shown in the circle, it can be torn open from the front end and directly removed from the catheter 17, which is more convenient for users to operate.

[0236] In one variation, the delivery sheath 3 may be a tubular structure with a complete leading end.

[0237] In one specific implementation, continue to refer to Figure 1 and Figure 13 The interventional device 1 may further include a balloon unit, which may include at least a balloon 12 , a catheter 17 (also referred to as a balloon catheter) and a guidewire 182 .

[0238] Specifically, the catheter 17 may have at least one lumen.

[0239] For example, reference Figure 13 The catheter 17 may include a first lumen 183 and a second lumen 184, which are isolated from each other. The first lumen 183 and the second lumen 184 both extend along the axial direction (e.g., the x-direction) of the catheter 17. The first lumen 183 communicates with the lumen of the balloon 12. The second lumen 184 serves as a passage for the guidewire 182 to move.

[0240] In some embodiments, the balloon 12 may be located at the front end 17b of the catheter 17, and the inner cavity of the balloon 12 is in communication with the first cavity 183 of the catheter 17. The first cavity 183 may be used to fill the balloon 12 with gas, saline, contrast fluid, and the like.

[0241] In a typical application scenario, combined with Figure 1 , when the stent 11 is in a contracted state (e.g., Figure 2 In the first state (shown in the figure), balloon 12 is also in a deflated state and is wrapped by stent 11. As balloon 12 and stent 11 move within delivery sheath 3 along guidewire 182, since both balloon 12 and stent 11 are in a deflated state, stent 11 adheres to the surface of balloon 12, wrapping around balloon 12. The two move together within delivery sheath 3 with their relative positions fixed. During this period, puncture portion 2 has previously passed through coating layer 151 and is in a non-erect position.

[0242] After reaching the target position in the tubular body, the balloon 12 and the stent 11 are released. At this time, the balloon 12 is filled with gas, physiological saline, contrast solution, etc. to make the balloon 12 enter a filled state.

[0243] When the balloon 12 is in the filled state, the balloon 12 expands and provides an expansion force to the stent 11 wrapped with the balloon 12, so that the stent 11 enters the expanded state. During this period, the puncture portion 2 is deformed to an upright state.

[0244] When the stent 11 is in the expanded state (e.g., Figure 1 and Figure 3In the second state shown in FIG, the stent 11 is in close contact with the inner wall of the blood vessel and supports the tip 2a of the puncture portion 2 to puncture the blood vessel, so that the tip 2a can be implanted into the brain tissue around the blood vessel.

[0245] Furthermore, the rear end 17a of the catheter is provided with an opening for a guidewire 182 to extend into. The opening is connected to the second lumen 184. The guidewire 182 extends through the opening into the second lumen 184 and to the front end 17b of the catheter 17. The front end 17b of the catheter 17 is closed. When delivering the balloon stent within a human blood vessel, the guidewire 182 can guide the entire catheter 17.

[0246] Furthermore, the balloon 2 before being filled may be in a folded structure with two, three or five folds inside the delivery sheath 3. The two, three or five folds may be folded in a manner similar to a folding umbrella.

[0247] Furthermore, the electrode wires 14 may be routed along the inner surface 11 a of the bracket 11 , or along the outer surface 11 b of the bracket 11 , to electrically connect the corresponding electrodes 13 and external devices.

[0248] In a typical application scenario, due to the tortuous and soft nature of intracranial blood vessels, both the delivery sheath 3 and the catheter 17 need to have high passability and deliverability. During interventional treatment, the target location is first determined through angiography. Then, the delivery sheath 3 is delivered into the blood vessel through the femoral vein, jugular vein, femoral artery, or brachial artery. The catheter 17 is accommodated in the delivery sheath 3. When the delivery sheath 3 reaches the target blood vessel, the guidewire 182 also guides the catheter 17 along the pathway to the target location.

[0249] After the delivery sheath 3 and the catheter 17 have reached the target position, the delivery sheath 3 is withdrawn to release the balloon 12 and the stent 11 from the delivery sheath 3. At this time, the stent 11 is in a released state, and the puncture portion 2 on the stent 11 is in an upright state.

[0250] Then, the filling seat (for example, the filling tube port 19) at the rear end 17a of the catheter is connected to the filling device (not shown), and an appropriate volume of contrast fluid (or saline) is filled into the cavity of the balloon 12 through the first cavity 183 to expand the balloon 12, thereby further expanding the stent 11 and putting it into an expanded state.

[0251] During the expansion process of the stent 11 , the expansion force of the stent 11 causes the puncture portion 2 on the stent 11 to puncture through the blood vessel wall and enter the brain tissue surrounding the blood vessel.

[0252] After the stent 11 is pressed into the inner wall of the blood vessel, the tip 2a of the puncture portion 2 together with the electrode wire 132 provided thereon are also correspondingly implanted into the brain tissue surrounding the blood vessel.

[0253] Then, the balloon 12 is depressurized, and the balloon 12 changes from a filled state to a negative pressure state, and then the catheter 17 is withdrawn from the body.

[0254] In some embodiments, during implantation of the interventional device 1 , the real-time position of the balloon 12 can be displayed by a developing ring 171 provided on the catheter 17 .

[0255] For example, the number of the developing rings 171 may be two and they are respectively disposed on both sides of the bracket 11 along the x direction.

[0256] In some embodiments, the conduit 17 has a diameter of about 0.5-1 mm and a length in the x-direction of about 50-150 mm.

[0257] In some embodiments, the length of the balloon 12 along the x-direction is approximately 0.5-15 mm.

[0258] In some embodiments, the diameter of the stent 11 before expansion is about 0.5 mm-1.0 mm, and the diameter after expansion is about 1.5-2.0 mm.

[0259] From the above, the present embodiment can realize the effective implantation of the electrode 13 based on the interventional device, and the implanted electrode 13 can directly contact the target area of ​​biological tissue outside the tubular body, realize direct and unobstructed signal interaction, and greatly improve the effect of the electrode collecting signals and applying stimulation. Specifically, at least one puncture portion 2 is added to the bracket 11, and as the bracket 11 is expanded, the puncture portion 2 punctures the wall of the tubular body to create a channel for the electrode 13 to extend. Furthermore, the electrode 13 is introduced into the biological body through the tubular body along with the bracket 11, and is implanted into the target area near the tubular body through the channel created by the puncture portion 2. There is no longer any obstruction of the wall of the tubular body between the electrode 13 sent out of the tubular body through the channel and the target area, so that the electrode 13 can directly collect the electrical signal of the target area or directly apply the stimulation signal to the target area, and the implantation effect of the electrode 13 is greatly improved.

[0260] Furthermore, in specific application scenarios of brain-computer interfaces, a neural interface can be established between brain tissue and the interventional device 1 described in this embodiment, thereby realizing a brain-machine interface. Electrodes 13 provided on or carried by the puncture portion 2 can be used to collect brain wave signals or provide specific electrical signals for electrical stimulation of brain regions.

[0261] Furthermore, a coating layer 151 is added to the stent 11, and the tip 2a of the puncture portion 2 pre-passes through the coating layer 151. Thus, after the tip 2a punctures a blood vessel, the coating layer 151 can quickly adhere to the resulting wound, thereby preventing bleeding and helping to repair the blood vessel wound.

[0262] In this embodiment, the material used for the coating layer can be selected from at least one of the following materials: cellulose, chitin, hyaluronic acid, collagen, gelatin, sodium alginate, polyurethane (PU), polytetrafluoroethylene (PTFE), expanded polytetrafluoroethylene (EPTFE), polylactic acid (PAL), polylactic acid (PLLA), poly(l lactic acid), poly(D lactide), poly(PGA), polyols (PLLA ... acid), polycaprolactone (PCL), polyamide (PA), polyethylene terephthalate (PET), polyether block polyamide PEBAX, high-density polyethylene HDPE, thermoplastic polyurethane elastomer TPU, polyimide PI, polydimethylsiloxane PDMS, parylene, epoxy resin, polyamideimide PAI, polylactic acid PHA, polylactic acid-glycolic acid copolymer PHAH, poly(p-phenylene ether) C, SU8, silicone and silicone rubber.

[0263] Nickel-titanium alloy has the characteristics of shape memory effect, temperature control, superelasticity, fatigue resistance, and good biocompatibility. It is used as a medical material in clinical dentistry, gynecology, orthopedics, cardiovascular and other fields.

[0264] Medical nickel-titanium alloy is a metal that is primarily used to manufacture implantable medical devices. Nickel-titanium alloy is a shape memory alloy that automatically returns to its original state within a specific temperature range after plastic deformation. Shape memory metals have advantages such as good biocompatibility and fast stress recovery. In the medical field, the shape memory metal suitable for implantation in the human body is mainly nickel-titanium alloy, because it has good biocompatibility and its properties can be changed by adjusting its composition. Shape memory metals are particularly suitable for use in stents in the body, such as heart stents. As a treatment for vascular diseases, heart stents usually use nickel-titanium alloys.

[0265] In an embodiment of the present invention, the material of the stent is selected from any one of the following or a combination of the following: nickel, titanium, nickel-titanium alloy, cobalt, cobalt alloy, chromium, cobalt-chromium alloy, magnesium, magnesium alloy, zinc alloy, and stainless steel.

[0266] In an embodiment of the present invention, the material of the puncture portion is selected from any one of the following or a combination of the following: nickel, titanium, nickel-titanium alloy, cobalt, cobalt alloy, chromium, cobalt-chromium alloy, magnesium, magnesium alloy, zinc alloy, and stainless steel.

[0267] In an embodiment of the present invention, the material of the electrode sites is selected from any one of the following or a combination of the following: gold, platinum, iridium, tungsten, magnesium, molybdenum, platinum-iridium alloy, titanium alloy, graphite, carbon nanotubes, polyethylenedioxythiophene PEDOT and its derivative polymers, poly(p-styrene sulfonic acid), polypyrrole, and iridium oxide.

[0268] In an embodiment of the present invention, the material of the metal layer is selected from any one of the following or a combination of the following: gold, platinum, iridium, tungsten, magnesium, molybdenum, platinum-iridium alloy, and titanium alloy.

[0269] In an embodiment of the present invention, the material of the insulating layer is selected from any one of the following or a combination of the following: polyimide PI, polydimethylsiloxane PDMS, polyparaxylene Parylene, polyethylene terephthalate PET, epoxy resin, polyamide-imide PAI, polylactic acid PHA, polylactic acid-hydroxyacetic acid copolymer PHAH, poly(p-phenylene ether) C, SU8, silicone and silicone rubber.

[0270] In an embodiment of the present invention, the material of the degradable layer is selected from any one of the following or a combination of the following: polylactic acid PLA, a synthetic material of polylactic acid PLGA, and magnesium alloy.

[0271] Although the present invention is disclosed as above, the present invention is not limited thereto. Any person skilled in the art can make various changes and modifications without departing from the spirit and scope of the present invention. Therefore, the scope of protection of the present invention should be based on the scope defined by the claims.

Claims

1. An interventional device for a tubular body, characterized in that: include: a bracket, switchable between a first state and a second state, wherein a diameter of the bracket in the second state is larger than a diameter in the first state; at least one puncture portion provided on the stent, the puncture portion being configured to puncture the wall of the tubular body when the stent is in the second state; at least one electrode disposed at the at least one puncture portion, the electrode being configured to extend outside the tubular body from an area of ​​the wall punctured by the puncture portion; The electrode comprises: an electrode wire, the electrode wire comprising at least one second electrode site, the puncture portion being adapted to carry at least a portion of the electrode wire and extend out of the tubular body from the area of ​​the wall punctured by the puncture portion; The puncture part has a cavity for accommodating the electrode wire. The tip of the puncture part is provided with an opening communicating with the cavity, and the electrode wire can extend out of the puncture part from the opening.

2. The interventional device according to claim 1, wherein: The stent is in a grid shape, and the at least one puncture portion is distributed at the intersection of the grid or the edge connecting adjacent intersections; and / or, the stent is in a corrugated shape, and the at least one puncture portion is distributed at different positions of the stent.

3. The interventional device according to claim 1, wherein: The puncture portion can be switched between a non-upright state and an upright state. In the upright state, the puncture portion substantially extends along the radial direction of the stent.

4. The interventional device according to claim 3, characterized in that The puncture portion is elastically deformable between the non-upright state and the upright state; and / or, the puncture portion is made of nickel titanium.

5. The interventional device according to claim 3, wherein: The length of the puncture portion in the upright state along the extension direction is greater than the thickness of the wall; and / or, there are multiple puncture portions, and the length of at least one puncture portion in the upright state along the extension direction is different from the length of other puncture portions in the upright state along the extension direction.

6. The interventional device according to claim 1, wherein: The puncture portion is cone-shaped, or at least the end of the puncture portion away from the stent is in a needle-tip structure.

7. The interventional device according to claim 1, wherein: The puncture portion and the bracket are integrally formed, or the puncture portion is connected to the bracket via a medium, and the medium is selected from at least one of an adhesive and a solder.

8. The interventional device according to claim 1, wherein: The at least one puncture portion corresponds to the at least one electrode one to one, or a single puncture portion corresponds to a plurality of electrodes.

9. The interventional device according to claim 1, wherein: The electrode includes: a first electrode site, which is at least arranged at the tip of the puncture part.

10. The interventional device according to claim 9, characterized in that The first electrode site is formed by a metal layer covering the outer surface of the puncture portion.

11. The interventional device according to claim 10, characterized in that A portion of the outer surface of the metal layer is coated with an insulating layer.

12. The interventional device according to claim 9, wherein: Also includes: An electrode lead is electrically connected to the first electrode site.

13. The interventional device according to claim 12, wherein: The electrode wire and the first electrode site are electrically connected via conductive glue.

14. The interventional device according to claim 1, wherein: The electrode wire is provided with a hole portion, and the hole portion is sleeved on the tip of the puncture portion.

15. The interventional device according to claim 14, wherein: The outer surface of the puncture portion is covered with an insulating layer and / or a degradable layer.

16. The interventional device according to claim 14, wherein: After at least a portion of the electrode wire extends out of the tubular body from the area on the wall pierced by the puncture portion, the stent can return to the first state and be withdrawn from the tubular body.

17. The interventional device according to claim 14, wherein: The electrode wire holes of the plurality of electrode wires are sleeved on the tip of the same puncture part.

18. The interventional device according to claim 14, wherein: A through hole communicating with the cavity is provided at the connection between the puncture portion and the bracket for the electrode wire to pass through.

19. The interventional device according to claim 14, wherein: Also includes: The electrode wire guide is accommodated in the cavity and is used to guide the electrode wire to extend from the opening to outside the puncture portion.

20. The interventional device according to claim 1, wherein The electrode wire extends along the outer side and / or inner side of the stent to the puncture portion.

21. The interventional device according to claim 20, wherein: Also includes: A fixing layer is provided, wherein the portion of the electrode wire extending along the bracket is sandwiched between the fixing layer and the bracket.

22. The interventional device according to claim 1, wherein Also includes: A blocking portion at least surrounds the puncture portion and is provided on the outer surface and / or inner surface of the stent. The blocking portion is used to block the gap between the wall and the puncture portion.

23. The interventional device according to claim 22, wherein: The blocking portion includes a coating layer.

24. The interventional device according to claim 23, wherein: When the stent is in the first state, at least the tip of the puncture portion is farther away from the stent than the coating layer.

25. The interventional device according to claim 1, wherein Also includes: A delivery sheath is detachably sleeved on the stent in the first state, and is used to keep the stent in the first state.

26. The interventional device according to claim 25, wherein The end portion of the delivery sheath tube adjacent to the stent can be torn apart in a radial direction so as to be deployed in a two-dimensional plane.

27. The interventional device according to claim 1, wherein Also includes: A balloon, the stent is sleeved on the balloon, and the balloon is used to switch the stent from the first state to the second state.

28. The interventional device according to claim 1, wherein The tubular body includes a blood vessel.

29. The interventional device according to claim 1, wherein The material of the stent is selected from any one of the following or a combination of the following: nickel, titanium, nickel-titanium alloy, cobalt, cobalt alloy, chromium, cobalt-chromium alloy, magnesium, magnesium alloy, zinc alloy, and stainless steel.

30. The interventional device according to claim 1, wherein The material of the puncture portion is selected from any one of the following or a combination of the following: nickel, titanium, nickel-titanium alloy, cobalt, cobalt alloy, chromium, cobalt-chromium alloy, magnesium, magnesium alloy, zinc alloy, and stainless steel.

31. The interventional device according to claim 1, wherein The material of the second electrode site is selected from any one of the following or a combination of the following: gold, platinum, iridium, tungsten, magnesium, molybdenum, platinum-iridium alloy, titanium alloy, graphite, carbon nanotubes, polyethylenedioxythiophene PEDOT and its derivative polymers, poly(p-styrene sulfonic acid), polypyrrole, and iridium oxide.

32. The interventional device according to claim 23, wherein The material of the coating is selected from any one of the following or a combination of the following: cellulose, chitin, hyaluronic acid, collagen, gelatin, sodium alginate, polyurethane PU, polytetrafluoroethylene PTFE, expanded polytetrafluoroethylene E PTFE, polylactic acid PAL, left-handed polylactic acid PLLA, right-handed polylactic acid PDLLA, polyglycolic acid PGA, polycaprolactone PCL, polyamide PA, polyethylene terephthalate PET, polyether block polyamide PEBAX, high-density polyethylene HDPE, thermoplastic polyurethane elastomer TPU, polyimide PI, polydimethylsiloxane PDMS, polyparaxylene Parylene, epoxy resin, polyamideimide PAI, polylactic acid PHA, polylactic acid-glycolic acid copolymer PHAH, poly(p-phenylene ether) C, SU8, silicone and silicone rubber.

33. The interventional device according to claim 10, wherein: The material of the metal layer is selected from any one of the following or a combination of the following: gold, platinum, iridium, tungsten, magnesium, molybdenum, platinum-iridium alloy, and titanium alloy.

34. The interventional device according to claim 11, wherein The material of the insulating layer is selected from any one of the following or a combination of the following: polyimide PI, polydimethylsiloxane PDMS, polyparaxylene Parylene, polyethylene terephthalate PET, epoxy resin, polyamideimide PAI, polylactic acid PHA, polylactic acid-glycolic acid copolymer PHAH, poly(p-phenylene ether) C, SU8, silicone and silicone rubber.

35. The interventional device according to claim 15, wherein The material of the degradable layer is selected from any one of the following or a combination of the following: polylactic acid PLA, a composite of polylactic acid PLGA, and magnesium alloy.

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