Interventional device for tubular bodies

Abstract

An interventional device for a tubular body, comprising: a stent switchable between a first state and a second state, the diameter of the stent in the second state being greater than the diameter of the stent in the first state; the at least one puncture part is arranged on the stent, and the puncture part is used for puncturing the wall of the tubular body when the stent is in the second state; the at least one electrode is arranged on the at least one puncture part, and the electrode is used for extending out of the tubular body from the area, punctured by the puncture part, of the wall. By means of the scheme, effective implantation of the electrode can be achieved based on the intervention device, the implanted electrode can make direct contact with the biological tissue target area outside the tubular body, direct and non-barrier signal interaction is achieved, and the signal collecting and stimulation applying effects of the electrode are greatly improved.

Description

Technical Field

[0001] This invention relates to the field of medical device technology, and more specifically to an interventional device for tubular bodies. Background Technology

[0002] In the field of medical devices, electrodes for sensing brainwave signals (such as rigid electrodes and flexible electrodes) are widely researched and applied. Electrodes are placed in locations close to brain tissue (such as on the skull, on the dura mater, or under the dura mater) or implanted into the brain tissue.

[0003] The current common procedure for implanting electrodes in the brain involves first opening the scalp and skull to expose the brain tissue, and then placing the electrodes on or implanting them into the brain tissue. This invasive implantation method, because it requires opening the skull to expose the brain tissue, can lead to various adverse reactions and may even affect the health and safety of the organism.

[0004] Another way to sense brain signals or stimulate brain tissue is through vascular intervention. This method delivers sensing and / or stimulating devices (e.g., electrodes) to the target location via blood vessels, a natural pathway in the body. While this allows for non-invasive signal acquisition from brain tissue, the quality and quantity of brainwave signals acquired by the implanted electrodes are poor, affecting the signal acquisition effectiveness of the implanted electrodes. Summary of the Invention

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

[0006] To address the aforementioned technical problems, embodiments of the present invention provide an interventional device for a tubular body, comprising: a stent switchable between a first state and a second state, wherein the diameter of the stent in the second state is larger than the diameter in the first state; at least one puncture portion disposed 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 disposed on the at least one puncture portion, the electrode being used to extend out of the tubular body from the area of ​​the wall punctured by the puncture portion.

[0007] Optionally, the stent is grid-shaped, and the at least one puncture portion is located at the intersection of the grid or on the edge connecting adjacent intersections; and / or, the stent is corrugated, and the at least one puncture portion is located at different positions on the stent.

[0008] Optionally, the puncture portion can switch between a non-erect state and an erect state, wherein the puncture portion in the erect state extends substantially radially along the support.

[0009] Optionally, the puncture portion may elastically deform between the non-upright state and the upright state; and / or, the puncture portion may be 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, the number of puncture portions is multiple, 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 conical, or at least the end of the puncture portion away from the support has a needle-like structure.

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

[0013] Optionally, the at least one puncture site and the at least one electrode correspond one-to-one, or a single puncture site corresponds to multiple electrodes.

[0014] Optionally, the electrode includes: a first electrode site, at least disposed at the tip of the puncture site.

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

[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 electrically connected to the first electrode site.

[0018] Optionally, the electrode wire and the first electrode site are electrically connected by conductive adhesive.

[0019] Optionally, the electrode includes an electrode wire, the electrode wire including at least one second electrode site, and the puncture portion is adapted to carry at least a portion of the electrode wire extending 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, which is fitted onto the tip of the puncture site.

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

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

[0023] Optionally, the electrode wire holes of multiple electrode wires are fitted onto the tip of the same puncture site.

[0024] Optionally, the puncture portion has a cavity for accommodating the electrode wire, and the tip of the puncture portion has an opening communicating with the cavity, through which the electrode wire can extend beyond the puncture portion.

[0025] Optionally, a through hole is provided at the connection between the puncture site and the support to allow the electrode wire to pass through.

[0026] Optionally, the interventional device further includes an electrode wire guide housed within the cavity, the electrode wire guide being used to guide the electrode wire to extend out of the puncture site from the opening.

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

[0028] Optionally, the interventional device further includes a fixation layer, wherein a portion of the electrode wire extending along the support is clamped between the fixation layer and the support.

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

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

[0031] Optionally, during the first state, at least the tip of the puncture portion is further away from the stent than the covering layer.

[0032] Optionally, the interventional device further includes a delivery sheath detachably fitted onto the stent in the first state, the delivery sheath being used to hold the stent in the first state.

[0033] Optionally, the end of the delivery sheath near the support can be torn radially to unfold into a two-dimensional plane.

[0034] Optionally, the interventional device further includes a balloon, the stent being fitted onto the balloon, the balloon being used to switch the stent from the first state to the second state.

[0035] Optionally, the tubular body includes blood vessels.

[0036] Optionally, the material of the support is selected from any one 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.

[0037] Optionally, the material of the puncture site is selected from any one 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 or a combination of the following: gold, platinum, iridium, tungsten, magnesium, molybdenum, platinum-iridium alloy, titanium alloy, graphite, carbon nanotubes, polyethylene dioxythiophene (PEDOT) and its derivative polymers, poly(p-styrene sulfonic acid), polypyrrole, and iridium oxide.

[0039] Optionally, the coating material is selected from any one or a combination of the following: cellulose, chitin, hyaluronic acid, collagen, gelatin, sodium alginate, polyurethane (PU), polytetrafluoroethylene (PTFE), expanded polytetrafluoroethylene (EPTFE), polylactic acid (PAL), L-polylactic acid (PLLA), D-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), parylene, epoxy resin, polyamide-imide (PAI), polylactic acid (PHA), polylactic acid-glycolic acid copolymer (PHAH), poly(terephthalic acid) ether (C), SU8, silicone, and silicone rubber.

[0040] Optionally, the material of the metal layer is selected from any one 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 or a combination of the following: polyimide PI, polydimethylsiloxane PDMS, parylene, polyethylene terephthalate PET, epoxy resin, polyamide-imide PAI, polylactic acid PHA, polylactic acid-glycolic acid copolymer PHAH, poly(p-phenylene ether) C, SU8, silicone, and silicone rubber.

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

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

[0044] This invention provides an interventional device for a tubular body, comprising: a stent switchable between a first state and a second state, wherein the diameter of the stent in the second state is larger than the diameter in the first state; at least one puncture portion disposed on the stent for puncturing the wall of the tubular body when the stent is in the second state; and at least one electrode disposed on the at least one puncture portion for extending out of the tubular body from the area of ​​the wall punctured by the puncture portion.

[0045] Compared to existing methods where electrodes implanted via interventional devices are attached to the inner wall of a tubular body, interacting with the target area through the tubular wall and severely impacting signal acquisition and stimulation effectiveness, this embodiment achieves effective electrode implantation using an interventional device for tubular bodies. The implanted electrode can directly contact the target area of ​​biological tissue outside the tubular body, enabling direct and unobstructed signal interaction and significantly improving signal acquisition and stimulation effectiveness. Specifically, at least one puncture site is added to the stent. As the stent expands within the tubular body, the puncture site pierces the tubular wall, creating a channel for the electrode to extend. Furthermore, the electrode, along with the stent, is inserted into the biological body through the tubular body and implanted into the target area near the tubular body via the channel created by the puncture site. With the electrode delivered outside the tubular body through the channel, there is no longer a tubular wall obstructing the target area, allowing the electrode to directly acquire electrical signals from the target area or directly apply stimulation signals, thus greatly improving the electrode implantation effect.

[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 the interface between the brain and the machine. Electrodes set or carried on the puncture site can be used to collect brain wave signals or provide specific electrical signals for brain region electrical stimulation.

[0047] Furthermore, the electrode includes a first electrode site, at least disposed at the tip of the puncture portion. Thus, by placing the electrode site at the tip of the puncture portion, the electrode site at the tip is simultaneously implanted into the target area while the puncture portion punctures the wall of the tubular body. Furthermore, the first electrode site is formed by a metal layer covering the outer surface of the puncture portion, to help the surface of the puncture portion simultaneously achieve both puncture and implantation functions, allowing the electrode implantation to be completed in one step as the stent expands.

[0048] Furthermore, the electrode includes an electrode wire with at least one second electrode site. The puncture portion is adapted to carry at least a portion of the electrode wire, extending out of the tubular body from the area punctured by the puncture portion on the wall. Thus, by carrying the electrode wire through the puncture portion, the electrode wire can pass through the wall of the tubular body and reach outside the tubular body, achieving direct contact with the target area. Furthermore, electrode wires prepared using any existing process can be carried by the puncture portion for implantation, which improves the compatibility of the interventional device described in this embodiment and enhances its adaptability to various types of electrode wires. Attached Figure Description

[0049] Figure 1 This 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 stent in its first state;

[0051] Figure 3 yes Figure 1 A schematic diagram of the stent in its second state;

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

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

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

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

[0056] Figure 8 This is a schematic cross-sectional view of a puncture site 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 site shown;

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

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

[0060] Figure 12 yes Figure 11 A magnified view of a portion of region A in the middle;

[0061] Figure 13 yes Figure 1 Cross-sectional view along the BB direction. Detailed Implementation

[0062] As mentioned in the background section, existing electrode implantation using vascular intervention methods can only acquire brain wave signals of poor quality and in very limited quantity.

[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 expands in the blood vessel, and the disc-shaped electrode is attached to the inner wall of the blood vessel. The sensed brain wave signal is a mixture of signals from numerous neurons in the brain tissue around the blood vessel.

[0064] Electrodes implanted via vascular intervention can only collect brain signals through the blood vessel wall. The electrode pads located within the blood vessel are separated from the neurons in the surrounding brain tissue by the blood vessel wall and cerebrospinal fluid. This means that the electrode pads do not directly collect or stimulate the neurons, resulting in poor quality and a very limited quantity of brainwave signals that can be acquired. The brainwave signals acquired by the electrode pads are a mixture of signals from numerous neurons in the perivascular brain tissue. These mixed signals cannot characterize the signal characteristics of specific neurons, nor can they clearly characterize the functional features of brain regions. Furthermore, distinguishing these mixed signals is extremely difficult. Moreover, after analysis and decoding, very little information from these brainwave signals can be used for amyotrophic lateral sclerosis (ALS), limiting their application to limited behavioral control, such as moving and confirming mouse cursors with eye-tracking devices.

[0065] To address the aforementioned technical problems, embodiments of the present invention provide an interventional device for a tubular body, comprising: a stent switchable between a first state and a second state, wherein the diameter of the stent in the second state is larger than the diameter in the first state; at least one puncture portion disposed 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 disposed on the at least one puncture portion, the electrode being used to extend out of the tubular body from the area of ​​the wall punctured by the puncture portion.

[0066] This embodiment enables effective electrode implantation based on the interventional device, allowing the implanted electrode to directly contact the target area of ​​biological tissue outside the tubular body, achieving direct and unobstructed signal interaction and significantly improving the electrode's signal acquisition and stimulation effects. Specifically, at least one puncture site is added to the stent. As the stent expands within the tubular body, the puncture site pierces the tubular wall to form a channel for the electrode to extend. Furthermore, the electrode, along with the stent, is inserted into the biological body through the tubular body and implanted into the target area near the tubular body through the channel created by the puncture site. With no longer the tubular wall obstructing the electrode extending beyond the tubular body, the electrode can directly acquire electrical signals from the target area or directly apply stimulation signals to the target area, greatly improving the electrode implantation effect.

[0067] To make the above-mentioned objects, features, and beneficial effects of the present invention more apparent and understandable, specific embodiments of the present invention will be described in detail below with reference to the accompanying drawings. The same reference numerals are used to label the same parts in each figure. The embodiments are merely illustrative, and of course, partial substitutions or combinations can be made to the structures shown in different embodiments. In the modified examples, descriptions of matters identical to those in the first embodiment are omitted, and only the differences are described. In particular, the same effects produced by the same structure will not be mentioned one by one in each embodiment.

[0068] Figure 1 This is a 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 means for sensing and / or stimulating tissue. For example, the interventional device 1 may integrate the means for sensing and / or stimulating tissue; in other words, the interventional device 1 described in this embodiment can itself be considered as a means for sensing and / or stimulating tissue. As another example, the interventional device 1 may carry the means for sensing and / or stimulating tissue. After the means for sensing and / or stimulating tissue, such as an electrode, is implanted into the target area via a tubular body through an interventional procedure, the interventional device 1 can be withdrawn from the tubular body, at which point the electrode remains in the target area.

[0070] The tissue can be, for example, cells (e.g., neurons) of an organism (e.g., the brain).

[0071] The device for sensing and / or stimulating tissue may be, for example, an electrode. In some embodiments, the electrode may include a flexible electrode. The flexibility of a flexible electrode can specifically be reflected in that the electrode has a flexible structure that can be bent / folded as needed. The definition of a flexible electrode can be found in general definitions in the art.

[0072] The tubular body can be, for example, a blood vessel, trachea, esophagus, renal tubule, larynx, duct, etc.

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

[0074] Specifically, refer to Figures 1 to 3 The interventional device 1 for tubular bodies described in this embodiment may include a stent 11, which can be in a first state (such as...) Figure 2 (as shown) and the second state (as shown) Figure 1 and 3 The diameter of the bracket 11 in the second state is greater than that in the first state when it is switched between the two states (as shown).

[0075] The support 11 can also be referred to as a support frame. For example, the support 11 can at least have a retracted state (e.g., Figure 2 The first state shown), the released state, and the expanded state (e.g., Figure 1 and Figure 3 (The second state shown). In some embodiments, the stent 11 can be constrained to a contracted state by an external force, and enters a released state when the external force is removed, and further enters an expanded state under its own deformation and / or the action of another external force. The external force can, for example, come from a delivery sheath 3 fitted onto the stent 11 (such as...). Figure 11 As shown), another external force can come from, for example, the balloon 12 (refer to balloon stents in the prior art). In one specific embodiment, the stent 11 can be an overall ring structure, such as a ring-shaped wave structure.

[0076] For ease of description, the radial direction of the stent 11 is denoted as the r direction, and the axial direction of the stent 11 is denoted as the x direction. The stent 11 has an inner surface 11a and an outer surface 11b along the radial direction. The inner side of the inner surface 11a faces the balloon 12, and the outer side of the outer surface 11b faces the wall of the tubular body.

[0077] Further reference Figures 1 to 3 The interventional device 1 may also include at least one puncture part 2 disposed on the stent 11, the puncture part 2 being 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 substantially outward in a radial (e.g., r direction) manner, 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 tip 2a to ensure reliable puncture of the wall of the tubular body.

[0079] For example, multiple puncture sites 2 can be distributed at different locations on the stent 11, which helps to increase the contact points with the wall of the tubular body.

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

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

[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, there is a one-to-one correspondence between electrode wires 14 and electrodes 13.

[0083] Furthermore, the interventional device 1 may also include a balloon 12, with a stent 11 fitted onto the balloon 12. 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 fitted thereon may be collectively referred to as a balloon stent, which has at least a contracted state, a deployed state, and an inflated state. The balloon stent, as an implant, can move along the lumen of the tubular body to the target location.

[0084] In a typical application scenario, a balloon stent in a constricted state is delivered to the target location via interventional procedures. The balloon stent is then released, and gas or liquid is injected into the balloon 12 to open the stent 11, thereby causing the stent 11 to enter an inflated state. Figure 1 As shown. Under the action of expansion force, the puncture part 2 on the stent 11 can puncture the wall of the tubular body, and the tip 2a of the puncture part 2 can extend outside 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 in the axial direction (e.g., the x-direction) that matches the shape of the blood vessel. The stent 11 has self-supporting properties due to the material properties of the metal it is made of, and is contractile in both the axial (e.g., the x-direction) and radial (e.g., the r-direction).

[0086] In some embodiments, the support 11 may be made of a highly elastic alloy such as nickel-titanium.

[0087] In some embodiments, the support 11 may be manufactured by 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 enclosing it, and in an expanded state after being inflated by the inflated balloon 12. In both the released and expanded states, the stent 11 has a mesh-like morphology (e.g., Figure 1 and Figure 3 (as shown) or wavy (as shown) Figure 4 As shown), the entire support 11 exhibits a porous structure when viewed radially (as shown). Figure 1 and Figure 3 (as shown) or striped structure (such as) Figure 4 (As shown).

[0089] Taking a tubular body as a blood vessel and the target region as brain tissue as an example, the stent 11 is first delivered to the target location by the delivery sheath 3 during the delivery process. Then, by withdrawing the delivery sheath 3, the stent 11 is released and exposed in the blood vessel. At this time, the stent 11 is in a released state and has a certain degree of self-expansion property.

[0090] Then, by inflating the balloon 12 inside the stent 11 with gas or liquid, the stent 11 is further expanded and opened. Under the combined action of self-expansion and the inflation 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 come into contact with the brain tissue outside the blood vessel. This allows the electrode 13, located at the puncture portion 2, to come into contact with the brain tissue outside the blood vessel, thereby enabling the sensing of electroencephalogram (EEG) signals or the application of electrical stimulation. For example, the electrode 13 can be located at the tip 2a of the puncture portion 2. Alternatively, the tip 2a of the puncture portion 2 can carry the electrode 13.

[0091] Therefore, a puncture section 2 is provided on the stent 11, which can puncture the tubular body (e.g., blood vessel). An electrode 13 is also provided on the puncture section 2. After the puncture section 2 punctures the tubular body, the electrode 13 can contact the target area (e.g., brain tissue) outside the tubular body, thereby enabling the direct acquisition of electrical signals (e.g., electroencephalogram signals) from the target area or the transmission of stimulation signals to the target area.

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

[0093] In a specific implementation, refer to Figures 1 to 3The support 11 can be in the form of a mesh. Furthermore, at least one puncture point 2 can be disposed at a fulcrum of the support 11 or at other locations that can provide support. The fulcrum can be, for example, the intersection of supporting skeletons.

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

[0095] In some embodiments, the spacing between adjacent intersections of the mesh support 11 in the first state may be smaller than the spacing between adjacent intersections of the mesh support 11 in the second state.

[0096] In one variation, refer to Figure 4 The support 11 can be corrugated. Furthermore, at least one puncture portion 2 can be distributed at different locations on the support 11. For example, the puncture portions 2 can be set at the crests, troughs, and locations between the crests and troughs of the corrugations. Figures 2 to 4 The electrode wires 14 connecting each electrode 13 are not shown.

[0097] In a specific implementation, continue to refer to Figures 1 to 3 The puncture site 2 can be in a non-upright position (e.g., Figure 2 (as shown) and upright position (as shown) Figure 3 and Figure 1 The puncture section 2, which is in an upright position, extends substantially along the radial direction (e.g., the r direction) of the support 11 when switching between the two positions.

[0098] Specifically, refer to Figure 2 The non-upright position can be, for example, a lying position, where the angle between the extension direction of the puncture part 2 (e.g., the direction from the end connected to the stent 11 towards the tip 2a) and the axis of the stent 11 is essentially zero. Specifically, the angle refers to the angle between the extension direction of the puncture part 2 and the support surface that provides support for the puncture part 2. It should be noted that in practical applications, the specific value of the angle in the non-upright position can be reasonably determined within the range of [0, 90 degrees] based on the specific shape of the tubular body (e.g., degree of curvature, diameter, etc.) to facilitate the implantation of the interventional device 1 and to avoid the tip 2a of the puncture part 2 scratching the tubular body.

[0099] Furthermore, the upright position can include a near-upright position. As the stent 11 enters the released state, the puncture site 2 is inserted from... Figure 2The non-upright state shown is transformed into an upright or near-upright state, thereby maximizing the support force of the stent 11 during its expansion. This facilitates the puncture point 2's penetration of the tubular wall under the support of the expansion force of the stent 11. It should be noted that in practical applications, the specific value of the included angle in the upright state can be reasonably determined within the range of [0, 90) degrees according to the specific shape of the tubular body (e.g., degree of curvature, diameter, etc.) to ensure that the tip 2a of the puncture point 2 can smoothly pierce the tubular wall with the expanding stent 11 in the upright state.

[0100] In some embodiments, the puncture portion 2 may be made of a metal with good elasticity, such as nickel-titanium or its alloy, to provide elasticity to the puncture portion 2. This allows the puncture portion 2 to have a certain degree of bending ability and to self-recover 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 cannula of the entire interventional device 1) covering the stent 11 is retracted, the elasticity of the puncture section 2 allows it to return to an upright or near-upright state. At this time, the central axis of the puncture section 2 has a corresponding angle (e.g., preferably 90 degrees) between it and its support surface on the stent 11, so that the puncture section 2 obtains support force based on the support surface on the stent 11 to perform subsequent tubular puncture operations.

[0102] In some embodiments, provided that the puncture portion 2 in the upright state is sufficient to pierce the wall of the tubular body, the switching between the non-upright and upright states of the puncture portion 2 may not be limited to elastic deformation. For example, the puncture portion 2 may extend and retract radially (e.g., in the r direction) to switch between the non-upright and upright states.

[0103] In a typical application scenario, during the delivery of the interventional device 1 into a tubular biological tissue, such as a blood vessel, the stent 11, along with the puncture section 2, is retracted into the delivery sheath 3. Upon reaching the target location, the delivery sheath 3 is retracted, the stent 11 is released, and the puncture section 2 is also released. At this point, the puncture section 2 can self-reopen to an upright position.

[0104] In one specific implementation, the length of the puncture section 2 in its upright position along its extension direction is greater than the thickness of the tubular body wall. This ensures that the puncture section 2 can pierce the wall in the upright position, allowing the electrode 13 to extend to the outside of the tubular body. Furthermore, by rationally designing the length of the puncture section 2, there is sufficient clearance to penetrate brain tissue after piercing blood vessels, thereby ensuring that the electrode 13 can effectively establish a direct electrical connection with cranial nerves.

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

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

[0107] For example, the length of the puncture site 2 provided in different areas on the outer periphery of the stent 11 can be different in the upright state.

[0108] For example, puncture portions 2 of different lengths can be evenly distributed on the outer surface 11b of the support 11.

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

[0110] In some embodiments, for multiple puncture sites 2 that differ in length in the upright state, the length of each puncture site 2 along the extension direction may be the same in the non-upright state. This 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 multiple puncture parts 2 on the stent 11, it is possible to avoid collisions between adjacent puncture parts 2 and damage when the stent 11 is in the first state.

[0112] Furthermore, when the stent 11 is in the first position, adjacent puncture sites 2 can be stacked one on top of the other.

[0113] In one specific implementation, the puncture site 2 can be cone-shaped, such as... Figures 5 to 9 As shown. For example, it can have a narrow, elongated conical structure. The tip of the cone is suitable for forming the tip 2a.

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

[0115] In some embodiments, the puncture portion 2 may be manufactured by a processing technique such as etching.

[0116] In one embodiment, the puncture portion 2 can be fixed to the stent 11 by means of, for example, bonding or laser welding. Specifically, the puncture portion 2 can be connected to the stent 11 via a medium, which can be 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 welding agent.

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

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

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

[0120] For example, a single puncture site 2 can correspond to multiple electrodes 13. That is, a puncture site 2 can carry or be equipped with multiple electrodes 13 at the same time, which is beneficial to increase the number of electrodes 13 that can establish a direct connection with the target area after the puncture site 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, refer to Figure 10 A single puncture site 2 may include multiple needle tip structures, each of which may carry one or more electrodes 13 (e.g., electrode wires 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 a support 11. The needle tip structure may be hollow and communicate with an internal hollow region at its tip 2a, which is beveled to ensure it can pierce the wall of the tubular body. Alternatively, the needle tip structure may be solid, with the tip 2a fitted with a hole 134 for the electrode wire 132 to carry the electrode 13.

[0123] For example, a single puncture site 2 may include multiple cone-shaped structures, with one of the cone-shaped structures forming a tree-like branching structure. Each cone-shaped structure may carry or be provided with an electrode 13.

[0124] In a specific implementation, refer to Figure 5 Electrode 13 may include a first electrode site 131, at least disposed at the tip 2a of the puncture portion 2. In this embodiment, different functional structures are exemplarily distinguished by different types of filling in the exemplary cross-sectional views.

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

[0126] Furthermore, each first electrode site 131 can be adapted to form an electrode 13, with one first electrode site 131 provided at each tip 2a of each puncture portion 2. That is, the first electrode site 131 and the tip 2a correspond one-to-one.

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

[0128] Thus, by placing electrode sites at the tip 2a of the puncture section 2, the electrode sites at the tip 2a are simultaneously implanted into the target area while the puncture section 2 punctures the wall of the tubular body.

[0129] In some embodiments, the tip 2a itself may form the first electrode site 131. For example, the puncture portion 2 may be made entirely or at least at the tip 2a 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 metallic coating (e.g., a metal layer 21). The additional metal layer 21 helps to improve the 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 or a combination of gold, platinum, iridium, tungsten, magnesium, molybdenum, platinum-iridium alloy, and titanium alloy.

[0133] Therefore, the surface of the puncture site 2 can simultaneously achieve the functions of puncture and implantation, as well as site signal acquisition. With the expansion of the stent 11, the implantation of the electrode 13 can be completed in one step.

[0134] Furthermore, the material selection for the puncture part 2 itself is more flexible, and it is not limited to conductive materials. For example, the material selection for the puncture part 2 can be based on factors such as elasticity and hardness in an upright state. This helps to reduce costs and obtain a puncture part 2 with greater hardness to ensure puncture reliability. Furthermore, nickel-titanium can be used to make the puncture part 2 to balance elasticity and conductivity. Furthermore, a metal layer 21 of materials such as tungsten or gold can be coated on the outer surface of the puncture part 2 to further enhance conductivity.

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

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

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

[0138] In some embodiments, the material of the insulating layer 22 may be selected from any one or a combination of the following: polyimide PI, polydimethylsiloxane PDMS, parylene, polyethylene terephthalate PET, epoxy resin, polyamide-imide 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 adapted to ensure that, after the tip 2a pierces the wall of the tubular body, the exposed area can reliably connect to the cells at the target location.

[0140] In some embodiments, while 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 a specific implementation, continue to refer to Figure 5 The electrode wire 14 can be electrically connected to the first electrode point 131.

[0142] Specifically, the electrode wires 14 can correspond one-to-one with the first electrode sites 131, transmitting signals between the corresponding first electrode sites 131 and the outside world (e.g., computing devices) without interference.

[0143] For example, the puncture section 2 is cone-shaped, with one puncture section 2 corresponding to one cone, and a first electrode site 131 is provided at the tip of each cone. Correspondingly, each cone 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 serves as an electrical connection, while the wire sheath 142 serves as insulation, isolation, and protection.

[0145] In a specific implementation, refer to Figure 5 The electrode wire 14 and the first electrode site 131 can be electrically connected by conductive adhesive.

[0146] Specifically, conductive adhesive can be applied between the puncture site 2 and the stent 11.

[0147] For example, the puncture site 2 is coated at least at its bottom with a conductive adhesive (e.g., conductive glue) to form a conductive adhesive layer 23 between the bottom surface and the support 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, a fixing adhesive layer 24, a conductive adhesive layer 23, and the puncture portion 2 are sequentially stacked on the stent 11 from the inside to the outside 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. Then, a conductive adhesive can be applied to the fixing adhesive layer 24 to form a conductive adhesive layer 23. Finally, the puncture part 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 bond the puncture part 2 to the support 11 together with the fixing adhesive, but also further transmit the electroencephalogram (EEG) signals collected by the first electrode site 131 on the puncture part 2 to the electrode wire 14 through the conductive adhesive layer 23, or transmit the stimulation signals transmitted from the electrode wire 14 to the first electrode site 131 on the tip 2a to provide electrical stimulation to the brain tissue.

[0150] In some embodiments, the electrode wire 14 may be connected to the bottom or side of the puncture portion 2. For example, it may be connected to the conductive adhesive 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 support 11 may be greater than the projected area of ​​the conductive adhesive layer 23 on the support 11. Furthermore, the insulating layer 22 may 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, conductive adhesive can be applied around the connection between the puncture portion 2 and the fixing adhesive layer 24 (i.e., the side of the puncture portion 2), and the end of the electrode wire 14 can be attached to the area coated with conductive adhesive to achieve electrical connection.

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

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

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

[0156] Specifically, the electrode wire 132 can be a flexible structure that can be bent / folded as needed. Furthermore, the electrode wire 132 can be, for example, an ultra-flexible electrode wire with micron-scale dimensions.

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

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

[0159] Thus, the electrode wire 132 is carried by the puncture section 2 so that it can pass through the wall of the tubular body and reach outside the tubular body, achieving direct contact with the target area. Furthermore, the electrode wire 132 prepared by any existing process can be carried by the puncture section 2 to complete the implantation, which helps to improve the compatibility of the interventional device 1 described in this embodiment and increase its adaptability to various types of electrode wires 132.

[0160] In some embodiments, at least one second electrode site 133 may be arranged at intervals along the extension direction of the electrode wire 132. Each second electrode site 133 may independently establish a direct electrical connection with a cell in the target region.

[0161] In some embodiments, the electrode wire 132 may be fabricated using microelectromechanical processing (MEMS) technology. Specifically, the electrode wire 132 may include a second electrode site 133 and a wire structure (e.g., wiring inside the electrode wire).

[0162] The second electrode site 133 is the exposed metal site, also known as the electrode contact.

[0163] The wire structure is adapted to form an electrode wire 14 for transmitting EEG signals sensed or acquired by the second electrode site 133 to a back-end device (e.g., back-end portion 135), or for transmitting stimulation signals transmitted from the back-end device to brain tissue cells.

[0164] Furthermore, the second electrode site 133 is typically made of low-resistivity metals such as gold or platinum.

[0165] For example, refer to Figure 7 Each second electrode site 133 corresponds one-to-one with an electrode lead 14. The electrode lead 14 is used to transmit the electroencephalogram (EEG) signals sensed or acquired by the corresponding second electrode site 133 or to transmit stimulation signals from the backend device to neurons in the brain tissue. Each electrode lead 14 is separated by an insulating material.

[0166] Further, refer to Figure 6 and Figure 7 Along its extension direction, the electrode wire 132 may include a site segment 132a at the front end, a lead segment 132b in the middle, and a rear end segment 132c at the rear end. The site segment 132a is at least partially implanted into a target region (e.g., brain tissue) outside the tubular structure to sense electroencephalogram (EEG) signals or to deliver stimulation signals. The lead segment 132b is at least partially attached to the scaffold 11 (e.g., a covering layer 151 covering the scaffold 11) to secure the electrode wire 132 and facilitate stable signal transmission. The rear end segment 132c may be located outside the organism.

[0167] In some embodiments, Figures 6 to 10 The puncture section 2 described in the illustrated embodiment and the above-mentioned Figure 5 The main difference between the puncture section 2 in the illustrated embodiment is: Figures 6 to 10 In the embodiment shown, the puncture part 2 itself may not play (or not primarily play) a conductive role, and the electrical connection with the biological tissue in the target area is achieved by the electrode wire 132 carried outside the tubular body by the tip 2a of the puncture part 2.

[0168] In a specific implementation, refer to Figure 6 , Figure 7 and Figure 10 The electrode wire 132 can be carried outside the tubular body in the form of being sleeved on the puncture section 2.

[0169] Specifically, the puncture site 2 can be fixedly connected to the stent 11. For example, the connection can be made by bonding or welding, such as laser welding.

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

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

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

[0173] Furthermore, the hole 134 can be fitted onto the tip 2a of the puncture part 2.

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

[0175] Furthermore, after the electrode wire 132 is implanted into 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 directly transmitting stimulation signals to the neurons. In this way, EEG signals from specific brain regions can be directly sensed or acquired, with better signal quality and fewer mixed signals, facilitating subsequent signal processing and analysis, and even controlling external devices based on EEG signals.

[0176] In some embodiments, the electrode wire 132 may also be attached to the tip 2a by means of adhesion so that it can be implanted into the target area as the tip 2a is inserted into the target area.

[0177] Therefore, by adopting this implementation scheme, after the electrode wire 132 is implanted into the target area through the puncture part 2 on the stent 11, 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 implantation state of the puncture site 2.

[0179] Alternatively, the stent 11, along with the 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 punctured by the puncture portion 2 on the wall of the tubular body, 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 can form a protective layer on the surface of the puncture portion 2, and can further reduce the potential damage to the hole portion 134 by the metal tip 2a when the hole portion 134 is fitted with the tip 2a.

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

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

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

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

[0185] In a specific implementation, refer to Figure 8 and Figure 9 The electrode wire 132 can be carried outside the tubular body in a form that is housed inside the puncture section 2. That is, as described above... Figure 6 and Figure 10 The difference in the embodiment shown is that, in this embodiment, the electrode wire 132 of the interventional device 1 does not contact the wall of the tubular body during the puncture part 2 piercing the wall of the tubular body, but extends out of the tubular body through the inside of the support 11 and the inside of the puncture part 2.

[0186] Specifically, the puncture section 2 may have a cavity 26 for accommodating the electrode wire 132.

[0187] Furthermore, the tip 2a of the puncture section 2 has an opening 261 that communicates with the cavity 26, and the electrode wire 132 can extend out of the puncture section 2 through the opening 261. Thus, during the process of the tip 2a piercing the wall of the tubular body and entering the target area, the electrode wire 132 can be implanted into the target area outside the tubular body along with the tip 2a.

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

[0189] In some embodiments, the cross-section of the opening 261 at the tip 2a can be a slope, that is, the cross-section may not be perpendicular to the radial direction (e.g., the r direction) of the support 11. Thus, the tip 2a with the opening 261 is shaped like a needle tip, and while piercing the wall of the tubular body, the electrode wire 132 housed in the cavity 26 is delivered from the opening 261 to the tip 2a in a manner similar to needle injection, so as to achieve electrical connection with cells in the target region outside the tubular body.

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

[0191] In one specific implementation, a through hole 262 communicating with the cavity 26 can be provided at the connection between the puncture part 2 and the support 11 so that the electrode wire 132 can pass through.

[0192] Specifically, the connection point can be located, for example, at the bottom of the puncture section 2. Correspondingly, 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 section 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 by opening a hole directly below the cavity 26 in the radial direction (e.g., the r direction). The through-hole 262 communicates with the cavity 26, thereby allowing the electrode wire 132 to extend from the support 11 into the cavity 26 of the puncture section 2 through the through-hole 262. In other words, a section of the electrode wire 132, such as a wire segment 132b, can extend along the inner surface 11a of the support 11.

[0194] In one variation, the connection point may be located, for example, on the side of the puncture portion 2. For instance, an opening may be made on the side of the puncture portion 2 near the stent 11 for the electrode wire 132 to pass through. Correspondingly, a through-hole 262 extends along the axial direction (e.g., the x-direction) of the stent 11 to connect the cavity 26 and the outer surface 11b of the stent 11, with the electrode wire 132 extending along the outer side of the stent 11 to the puncture portion 2. Specifically, the outer side of the stent 11 may refer to the side facing the wall of the tubular body.

[0195] In some embodiments, the electrode wire 132 may be movable relative to the support 11.

[0196] Furthermore, when at least the stent 11 is in the first state, the tip 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 into the target area, the electrode wire 132 can extend from the opening 261 from the cavity 26 and be implanted into the target area.

[0197] In one embodiment, the interventional device 1 may further include an electrode wire guide (not shown) housed within the cavity 26, the electrode wire guide being used to guide the electrode wire 132 out of the puncture site 2 through the opening 261.

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

[0199] Specifically, the fixing layer 15 can be, for example, a coating layer 151. Electrode leads 14 or electrode wires 132 can extend between the support 11 and the coating layer 151.

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

[0201] Before use (e.g., when the stent 11 is in the first state), the tip 2a of the puncture portion 2 passes through the covering layer 151 beforehand. That is, during the period when the stent 11 is in the first state, at least the tip 2a of the puncture portion 2 is further away from the stent 11 than the covering 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 at this time, 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 covering layer 151.

[0203] In the unreleased state, the puncture section 2 can lie on the surface of the covering layer 151. In the subsequent release state, the puncture section 2 changes from the lying state (e.g., non-upright state) to the upright state so as to obtain the support force of the puncture tubule from the surface of the stent 11.

[0204] In some embodiments, the tip of the electrode wire 132 may have a certain amount of slack that is not clamped between the fixation layer 15 and the support 11, so as to ensure that after the tip 2a pierces the wall of the tubular body, the tip of the electrode wire 132 can move further out of the tubular body relative to the tip 2a, so as to ensure successful implantation into the target area and establish an electrical connection with the biological tissue in that area.

[0205] For example, the portion of the electrode wire 132 housed within the cavity 26 can be bent at least once to allow for some margin, and this portion of the electrode wire 132 can extend beyond the tip 2a from the opening 261 after the tip 2a pierces the wall of the tubular body.

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

[0207] In one specific implementation, the interventional device 1 may further include a blocking part 16, which is disposed on the outer surface 11b and / or inner surface 11a of the stent 11 at least around the puncture part 2, and the blocking part 16 is used to block the gap between the wall of the tubular body and the puncture part 2.

[0208] Specifically, the sealing portion 16 may include a coating layer 151, which may be made of a biocompatible medical coating material such as PTFE.

[0209] Furthermore, the coating layer 151 can be manufactured using various processing methods such as 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 material), thereby enabling it to have high adhesion to biological tissues.

[0210] The function of the covering layer can be to seal and stop bleeding on the wound of the tubular body after the puncture site 2 punctures the tubular body and implants it into the biological tissue of the target area, while also enabling the stent 11 to quickly form endothelialization on the inner wall of the tubular body.

[0211] In some embodiments, the covering layer 151 may exist only in the area where each puncture portion 2 is located. For example, the covering layer 151 may surround the area where the bottom end of the puncture portion 2 is located in order to specifically cover the tiny wound created by the tip 2a of the puncture portion 2 piercing the wall of the tubular body.

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

[0214] In some embodiments, the coating layer 151 may also be two or more layers of film. For example, Figure 9 The illustrated embodiments and Figure 8 The main difference in the illustrated embodiments is that, Figure 9 The interventional device 1 shown has a coating layer 151 arranged on the inner surface 11a and the outer surface 11b of the support 11.

[0215] Specifically, the puncture point 2 passes through the covering layer 151 located on the outer surface 11b of the stent 11 beforehand. The covering layer 151 located on the outer surface 11b of the stent 11 can seal the tiny wounds created 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 side to prevent fluid (e.g., blood in the blood vessel) in the tubular body 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, causing internal bleeding.

[0217] Furthermore, the electrode unit, including the electrode wire 132 and the electrode wire guide, can be pre-extended between the support 11 and the coating layer 151 located on the inner surface 11a of the support 11, and enter the cavity 26 through the through hole 262. Thus, the electrode unit can be fixed between the support 11 and the coating layer 151, at which point the coating layer 151 located on the inner surface 11a of the support 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 covering layer 151 located on the inner surface 11a of the stent 11 can provide a good seal and apply a certain pressure to the electrode unit on the blood vessel side, which is beneficial for the fixation of the electrode unit between the stent 11 and the covering layer 151, and also beneficial for the subsequent implantation of the electrode unit.

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

[0220] In some embodiments, the support 11 may be located between the coating layer 151 and the electrode wire 132 (or electrode lead 14) along the radial direction (e.g., the r direction), such as... Figure 8 As shown.

[0221] In some embodiments, the coating layer 151 may be located between the support 11 and the electrode wire 132 (or electrode lead 14) along the radial direction (e.g., the r direction) of the support 11, such as... Figure 6 As shown.

[0222] In a specific implementation, refer to Figure 11 and Figure 12 The interventional device 1 may further include a delivery sheath 3 for delivering the balloon stent to the target location of the tubular body. The balloon stent may include a balloon 12 and a stent 11 fitted onto the balloon 12.

[0223] Specifically, the delivery sheath 3 is detachably fitted onto the support 11 in the first state to hold the support 11 in the first state.

[0224] Furthermore, the delivery sheath 3 protects the balloon stent with the puncture site 2 from damage during delivery. Furthermore, the delivery sheath 3 overcomes resistance within the tubular structure to smoothly deliver the balloon stent structure to the target location.

[0225] Furthermore, the balloon 12 and the stent 11 of the balloon stent are placed radially superimposed, that is, they are in a concentric circle structure, with the stent 11 surrounding 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 superimposed balloon 12 and stent 11 in the contracted state.

[0226] Furthermore, the radially stacked balloon 12 and stent 11 can be pre-positioned within the delivery sheath 3. For example, the delivery sheath 3 can have an inner lumen 31 for accommodating the balloon and stent.

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

[0228] Furthermore, the delivery sheath 3 may also have a cannula segment 32 and a delivery segment 33, wherein the diameter of the cannula segment 32 is larger than the diameter of the delivery segment 33. Along the x-direction, the cannula segment 32 is positioned at the front end to accommodate the main body portion of the balloon stent, such as the portion containing the balloon 12 and stent 11. The delivery segment 33 is positioned 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 have a polymer coating.

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

[0232] In a specific implementation, continue to refer to Figure 11 and Figure 12 The delivery sheath 3 near the end (e.g., the front end) of the support 11 can be torn radially (e.g., in the r direction) to unfold into a two-dimensional plane.

[0233] Specifically, the delivery sheath 3 has a tubular structure with a tearable and deployable front end, as shown in the schematic diagram of its front end face. Figure 11 As shown.

[0234] Furthermore, the tearable and deployable tubular structure at the front end can be opened and removed from the front end after the delivery sheath 3 is retracted. This avoids damage to the electrode lead 14 and its rear end portion, as well as the rear end portion of the balloon 12.

[0235] For example, the delivery sheath 3 is withdrawn to the distal end 17a of the catheter (as shown). Figure 1 When the bifurcated structure (exemplary shown within the circle) is removed, it can be torn open from the front end and directly removed from the conduit 17, making it more convenient for the user.

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

[0237] In a specific implementation, continue to refer to Figure 1 and Figure 13 The interventional device 1 may also 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, catheter 17 may have at least one lumen.

[0239] For example, refer to Figure 13 The catheter 17 may include a first lumen 183 and a second lumen 184, which are isolated from each other. Both the first lumen 183 and the second lumen 184 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 channel for the movement of the guidewire 182.

[0240] In some embodiments, the balloon 12 may be located at the tip 17b of the catheter 17, and the inner lumen of the balloon 12 is in communication with the first lumen 183 of the catheter 17. Gas, saline, contrast fluid, etc. can be filled into the balloon 12 through the first lumen 183.

[0241] In a typical application scenario, combined with Figure 1 When the stent 11 is in the retracted state (e.g., as Figure 2 In the first state shown, the balloon 12 is also in a contracted state and is wrapped by the stent 11. As the balloon 12 and stent 11 move within the delivery sheath 3 along with the guidewire 182, since both the balloon 12 and stent 11 are in a contracted state, the stent 11 is attached to the surface of the balloon 12 in a manner that wraps around the balloon 12, and the two move together within the delivery sheath 3 in a fixed relative position. During this period, the puncture section 2 pre-passes through the covering layer 151 and is in a non-upright state.

[0242] After reaching the target location within the tubular body, balloon 12 and stent 11 are deployed. At this point, balloon 12 is inflated by filling it with gas, saline, contrast fluid, etc.

[0243] When the balloon 12 is inflated, it expands and provides an expansion force to the stent 11 surrounding the balloon 12, thereby causing the stent 11 to enter an expanded state. During this period, the puncture site 2 deforms into an upright state.

[0244] When the stent 11 is in the expanded state (e.g., as Figure 1 and Figure 3In the second state shown, the stent 11 is close to the inner wall of the blood vessel and supports the tip 2a of the puncture part 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 distal end 17a of the catheter is provided with an opening for the guidewire 182 to extend into. The opening communicates with the second lumen 184. The guidewire 182 extends into the second lumen 184 through the opening and extends to the distal end 17b of the catheter 17, which is closed. When delivering a balloon stent into a human blood vessel, the guidewire 182 can guide the entire catheter 17.

[0246] Furthermore, before being filled, the balloon 2 may exist within the delivery sheath 3 in a two-, three-, or five-fold folded structure. The two-, three-, or five-fold folds may be similar to the folding method of a folding umbrella.

[0247] Furthermore, the electrode wire 14 can be routed along the inner surface 11a of the bracket 11 or along the outer surface 11b of the bracket 11 to electrically connect the corresponding electrode 13 to the external device.

[0248] In a typical application scenario, given the tortuous and flexible nature of intracranial blood vessels, both the delivery sheath 3 and the catheter 17 need to have high permeability and delivery capability. During interventional treatment, the target location is first determined by 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 housed within the delivery sheath 3. When the delivery sheath 3 reaches the target blood vessel location, the guidewire 182 also guides the catheter 17 along the pathway to the target location.

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

[0250] Then, the filling seat (e.g., filling port 19) of the catheter rear end 17a 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 lumen 183, causing the balloon 12 to expand, thereby further expanding the stent 11 and entering the expansion state.

[0251] During the expansion of the stent 11, the expansion force of the stent 11 causes the puncture part 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 part 2, together with the electrode wire 132 set thereon, is also implanted into the brain tissue around the blood vessel.

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

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

[0255] For example, there can be two developing rings 171, which are respectively located on both sides of the support 11 along the x-direction.

[0256] In some embodiments, the diameter of the conduit 17 is about 0.5-1 mm, and its length along the x-direction is 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 support 11 before expansion is approximately 0.5 mm to 1.0 mm, and the diameter after expansion is approximately 1.5 mm to 2.0 mm.

[0259] Therefore, by adopting this embodiment, the electrode 13 can be effectively implanted based on the interventional device, and the implanted electrode 13 can directly contact the target area of ​​biological tissue outside the tubular body, achieving direct and unobstructed signal interaction, greatly improving the effect of electrode signal acquisition and stimulation application. Specifically, at least one puncture part 2 is added to the stent 11. As the stent 11 expands, the puncture part 2 punctures the wall of the tubular body to create a channel for the electrode 13 to extend. Further, the electrode 13 is inserted into the biological body through the tubular body along with the stent 11, and implanted into the target area near the tubular body through the channel created by the puncture part 2. There is no longer the obstruction of the tubular body wall between the electrode 13, which is delivered outside the tubular body through the channel, and the target area, so the electrode 13 can directly acquire electrical signals from the target area or directly apply stimulation signals to the target area, greatly improving the implantation effect of the electrode 13.

[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, realizing the interface between the brain and the machine. Electrode 13, set or carried on the puncture site 2, can be used to collect brainwave signals or provide specific electrical signals for brain region electrical stimulation.

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

[0262] In this embodiment, the material used for the coating layer may 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), poly(l lactic acid) (PLLA), poly(d-lactide) (PDLLA), and polyglycolic acid (PGA). Poly(acetic 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, polyamide-imide (PAI), polylactic acid (PHA), polylactic acid-glycolic acid copolymer (PHAH), poly(terephthalic acid) C, SU8, silicone, and silicone rubber.

[0263] Nickel-titanium alloys possess properties such as shape memory effect, temperature control, superelasticity, fatigue resistance, and good biocompatibility, making them suitable as medical materials for clinical applications in dentistry, gynecology, orthopedics, and cardiovascular fields.

[0264] Medical-grade nickel-titanium alloys are metals primarily used to manufacture implantable medical devices. Nickel-titanium alloys are shape memory alloys, meaning they automatically return to their original state within a specific temperature range after undergoing plastic deformation. Shape memory metals have advantages such as good biocompatibility and rapid stress recovery. In the medical field, nickel-titanium alloys are the most suitable shape memory metals for implantation because of their good biocompatibility and the ability to modify their properties by adjusting their composition. Shape memory metals are particularly suitable for use in in-body stents, such as cardiac stents, which are commonly used in the treatment of vascular diseases.

[0265] In embodiments of the present invention, the material of the support is selected from any one 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 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 embodiments of the present invention, the material of the electrode site is selected from any one or a combination of the following: gold, platinum, iridium, tungsten, magnesium, molybdenum, platinum-iridium alloy, titanium alloy, graphite, carbon nanotubes, polyethylene dioxythiophene (PEDOT) and its derivative polymers, poly(p-styrene sulfonic acid), polypyrrole, and iridium oxide.

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

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

[0270] In embodiments of the present invention, the material of the biodegradable layer is selected from any one or a combination of the following: polylactic acid (PLA), polylactic acid compound (PLGA), and magnesium alloy.

[0271] While the present invention has been disclosed above, it is not limited thereto. Any person skilled in the art can make various modifications and alterations without departing from the spirit and scope of the invention; therefore, the scope of protection of the present invention should be determined by the scope defined in 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 greater than a diameter of the bracket in the first state; at least one puncture portion, disposed on the stent, the puncture portion being used to puncture the wall of the tubular body when the stent is in the second state; At least one electrode is disposed at 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.

2. The interventional device according to claim 1, characterized in that The stent is in a grid shape, and the at least one puncture portion is distributed at the intersections of the grid or at the edges 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, characterized in that: 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.

4. The interventional device according to claim 3, characterized in that: The puncture portion can be elastically deformed 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, characterized in that: 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, characterized in that: The puncture portion is cone-shaped, or at least the end of the puncture portion away from the stent is a needle tip structure.

7. The interventional device according to claim 1, characterized in that: 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, characterized in that: The at least one puncture part corresponds to the at least one electrode one by one, or a single puncture part corresponds to a plurality of electrodes.

9. The interventional device according to claim 1, characterized in that: The electrode comprises: 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, characterized in that: Also includes: An electrode lead is electrically connected to the first electrode site.

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

14. The interventional device according to claim 1, characterized in that The electrode comprises an electrode wire, wherein the electrode wire comprises at least one second electrode site, and the puncture portion is adapted to carry at least a portion of the electrode wire and extend out of the tubular body from an area on the wall punctured by the puncture portion.

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

16. The interventional device according to claim 15, characterized in that The outer surface of the puncture portion is covered with an insulating layer and / or a degradable layer.

17. The interventional device according to claim 15, characterized in that: 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.

18. The interventional device according to claim 15, characterized in that: The electrode wire holes of the plurality of electrode wires are sleeved on the tip of the same puncture portion.

19. The interventional device according to claim 14, characterized in that: The puncture part has a cavity, and the cavity is used to accommodate the electrode wire. The tip of the puncture part is provided with an opening connected to the cavity, and the electrode wire can extend out of the puncture part from the opening.

20. The interventional device according to claim 19, characterized in that A through hole communicating with the cavity is provided at the connection between the puncture portion and the support for the electrode wire to pass through.

21. The interventional device according to claim 19, characterized in that Also includes: The electrode wire guide is received in the cavity and is used to guide the electrode wire to extend out of the puncture portion from the opening.

22. The interventional device according to claim 14, characterized in that The electrode wire extends along the outer side and / or inner side of the stent to the puncture portion.

23. The interventional device according to claim 22, characterized in that Also includes: A fixing layer is provided, and a portion of the electrode wire extending along the bracket is sandwiched between the fixing layer and the bracket.

24. The interventional device according to claim 1, characterized in that Also includes: A blocking portion at least surrounds the puncture portion and is disposed 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.

25. The interventional device according to claim 24, characterized in that The blocking portion includes a coating layer.

26. The interventional device according to claim 25, characterized in that 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.

27. The interventional device according to claim 1, characterized in that Also includes: A delivery sheath is detachably mounted on the stent in the first state, and is used to keep the stent in the first state.

28. The interventional device according to claim 27, characterized in that The end of the delivery sheath tube close to the stent can be torn apart in radial direction so as to be unfolded in a two-dimensional plane.

29. The interventional device according to claim 1, characterized in that 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.

30. The interventional device according to claim 1, characterized in that The tubular body includes a blood vessel.

31. The interventional device according to claim 1, characterized in that 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.

32. The interventional device according to claim 1, characterized in that The material of the puncture part 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.

33. The interventional device according to claim 14, characterized in that 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.

34. The interventional device according to claim 25, characterized in that 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.

35. The interventional device according to claim 10, characterized in that 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.

36. The interventional device according to claim 11, characterized in that 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, silica gel and silicone rubber.

37. The interventional device according to claim 16, characterized in that 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.

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