Electrode lead tip structure, electrode lead and electrode lead delivery system

Abstract

The application provides an electrode lead head end structure, an electrode lead and an electrode lead conveying system. The electrode lead head end structure comprises a first supporting unit, a flexible transition unit, a second supporting unit, a fixing unit and a driving electric connection unit. The first supporting unit, the flexible transition unit, the second supporting unit and the fixing unit are sequentially connected and form a cavity along the extension direction of the electrode lead head end structure from the proximal end to the distal end. The driving electric connection unit is at least partially located in the cavity. The flexible transition unit is configured to be able to bend when an external force is applied and to be able to restore to the original state after the external force is removed. The application is more convenient for an operator to control the electrode lead head end structure to pass through a delivery sheath, reduces the time required for surgical operation, thereby reducing the risk of infection of a patient, enabling the surgical operation to be smoothly performed and improving the success rate of the surgical operation.

Description

Technical Field

[0001] This invention relates to the field of medical device technology, and in particular to an electrode lead tip structure, an electrode lead, and an electrode lead delivery system. Background Technology

[0002] Existing electrode lead tip structures are long and rigid, making them inflexible. When the electrode lead passes through the sheath, it encounters significant resistance, sometimes even failing to pass through the sheath altogether. This resistance also easily damages the electrode lead, especially when the distal end uses an active spiral fixation method, further complicating its passage through the sheath. Designing a flexible, bendable lead tip structure with active spiral fixation could lead to deformation at the tip, hindering torque transmission and easily damaging the lead. Therefore, regardless of whether the lead tip structure is rigid or flexible, significant thrust and torsional forces are required during implantation, increasing both the risk of lead damage and the surgical complexity.

[0003] It should be noted that the information disclosed in the background section of this invention is intended only to enhance the understanding of the general background of this invention, and should not be construed as an admission or in any way implying that the information constitutes prior art known to those skilled in the art. Summary of the Invention

[0004] This invention addresses the problems of existing electrode lead tip structures, which are disadvantageous for operators in manipulating the electrode lead tip structure through the hollow transmission sheath and are prone to electrode lead damage. It provides an electrode lead tip structure, electrode lead, and electrode lead delivery system. This invention makes it easier for operators to manipulate the electrode lead tip structure through the transmission sheath, reducing the time required for surgical procedures, thereby reducing the risk of patient infection, enabling the surgery to proceed smoothly, and improving the success rate of the surgery.

[0005] To achieve the above objectives, the present invention provides the following technical solution: an electrode lead end structure, comprising: a first support unit, a flexible transition unit, a second support unit, a fixing unit, and a driving electrical connection unit;

[0006] Along the extension direction from the proximal end to the distal end of the electrode wire head end structure, the first support unit, the flexible transition unit, the second support unit, and the fixing unit are sequentially connected to form a cavity; the two ends of the cavity respectively penetrate the proximal end and the distal end of the electrode wire head end structure.

[0007] The drive electrical connection unit is located at least partially within the cavity;

[0008] The first support unit includes a rigid hollow insulating structure through which the drive electrical connection unit passes;

[0009] The flexible transition unit is configured to be able to bend when an external force is applied and to return to its original shape after the external force is removed.

[0010] Optionally, the first support unit, the flexible transition unit, the second support unit, and the fixing unit are hollow cylinders or hollow quasi-cylinders with collinear central axes.

[0011] Optionally, the diameter of the electrode lead end structure ranges from 1 mm to 3 mm, and the length of the electrode lead end structure ranges from 5 mm to 50 mm.

[0012] Optionally, the first support unit further includes a ring electrode disposed on the outer periphery of the rigid hollow insulating structure; the rigid hollow insulating structure of the first support unit includes a first insulating member and a first supporting member, both of which are annular bodies; wherein, the first insulating member is located between the ring electrode and the first supporting member, and the ring electrode, the first insulating member, and the first supporting member are sequentially and coaxially fixedly connected; the ring electrode is connected to the flexible transition unit.

[0013] Optionally, the flexible transition unit includes a transition hose and at least one connecting wire. The transition hose includes connecting holes that correspond one-to-one with the number of connecting wires. The connecting holes penetrate the tube body of the transition hose along the axial direction of the transition hose.

[0014] The length of the connecting wire is greater than the length of the transition hose. The connecting wire passes through the connecting hole, and the proximal end of at least one connecting wire is fixedly connected to the ring electrode, while the distal end of the connecting wire fixedly connected to the ring electrode is connected to the second support unit.

[0015] The transition hose and the connecting wire are configured to bend when an external force is applied and to return to their original shape after the external force is removed.

[0016] Optionally, there are at least two connection holes, and the plurality of connection holes are evenly distributed along the circumference of the transition hose; and / or the shape of the connection holes includes a cylinder, a triangular prism, or a polygonal prism.

[0017] Optionally, the shape of the connecting hole includes a cylindrical structure with a diameter ranging from 0.02 mm to 0.3 mm, a triangular prism with a cross-sectional side length ranging from 0.02 mm to 0.3 mm, or a polygonal prism with a cross-sectional diagonal length ranging from 0.02 mm to 0.3 mm.

[0018] Optionally, when an external force is applied to the transition hose and the connecting wire, the angle range of the central angle of the transition hose subjected to the external force is 45° to 180°.

[0019] Optionally, the outer diameter of the transition hose ranges from 1.5 mm to 3 mm; the length of the transition hose ranges from 2 mm to 20 mm.

[0020] Optionally, the second support unit includes a second insulating member and a second support member fixedly connected coaxially. Both the second insulating member and the second support member are annular bodies, and the second support unit is a rigid hollow insulating structure. The second support member is sleeved on the outer periphery of the second insulating member. The second support member is fixedly connected to the flexible transition unit.

[0021] Optionally, the drive electrical connection unit includes a drive unit and a telescopic pin; the drive unit is disposed in the cavity, and the distal end of the drive unit is connected to the proximal end of the telescopic pin.

[0022] The drive unit is configured to drive the telescopic needle to move along the extension direction of the electrode lead end structure.

[0023] Optionally, the fixing unit includes a fixing head and a fixing screw;

[0024] The proximal end of the fixing head is fixedly connected to the distal end of the second support unit, and the fixing screw is fixed to the distal end of the fixing head and extends in a direction away from the second support unit.

[0025] The telescopic needle passes through the fixed head, and under the drive of the drive unit, the distal end of the telescopic needle can move from the fixed head to the distal end of the fixed screw; the central axes of the telescopic needle, the fixed head, and the fixed screw are collinear.

[0026] Optionally, the drive electrical connection unit further includes a connector connecting the drive unit and the telescopic pin, the connector being located within the cavity corresponding to the second support unit and capable of sliding along the inner wall of the second support unit.

[0027] To achieve the above objectives, the present invention also provides an electrode wire, the electrode wire comprising a connecting end, a wire body, and an electrode wire head end structure as described above, which are sequentially connected along the direction from the proximal end to the distal end of the electrode wire.

[0028] To achieve the above objectives, the present invention also provides an electrode wire delivery system, the electrode wire delivery system comprising a delivery sheath and the electrode wires described in any of the above claims;

[0029] The transfer sheath includes a sheath inlet, a tube body, and a sheath outlet, and the tube body includes at least one bend;

[0030] The delivery sheath is used to deliver the aforementioned electrode wires to the target location in the target organ tissue.

[0031] Compared with the prior art, the electrode lead end structure, electrode lead, and electrode lead delivery system provided by the present invention also have the following beneficial effects:

[0032] The electrode lead end structure provided by this invention adopts the following design: The electrode lead end structure provided by this invention includes a first support unit, a flexible transition unit, a second support unit, a fixing unit, and a driving electrical connection unit; along the extension direction of the electrode lead end structure from the proximal end to the distal end, the first support unit, the flexible transition unit, the second support unit, and the fixing unit are sequentially fixedly connected to form a cavity; the two ends of the cavity respectively penetrate the proximal end and the distal end of the electrode lead end structure; the driving electrical connection unit is at least partially located in the cavity; wherein, the first support unit includes a rigid hollow insulating structure through which the driving electrical connection unit passes; the flexible transition unit is configured to be able to bend when an external force is applied and to return to its original shape after the external force is removed. Therefore, the electrode lead end structure provided by the present invention adopts a multi-segment, flexible-transition unit and a second support unit, with the first support unit being rigid, the flexible transition unit being able to bend under external force, and the second support unit being rigid. This combination of rigidity and flexibility allows the flexible transition unit of the electrode lead end structure to bend and deform under force when the operator passes the electrode lead end structure through the curved transmission sheath. This reduces the resistance experienced by the electrode lead within the transmission sheath, making it easier for the electrode lead to pass smoothly through the curved transmission sheath during implantation. Furthermore, when rotating to implant the electrode lead, the first support unit, flexible transition unit, and second support unit of the electrode lead end structure provided by the present invention can satisfy both torsional resistance and rigid support, as well as bending deformation requirements. In summary, the electrode lead tip structure provided by this invention is not only simple in structure, but also solves the problem that the rigid electrode tip is difficult to pass through the curved sheath, and the problem that the flexible electrode tip is prone to twisting and deformation and cannot provide anti-torsion and support. It makes it easier for the operator to manipulate the electrode lead tip through the transmission sheath, reducing the time required for surgical operation, thereby reducing the risk of infection for the patient, enabling the surgery to proceed smoothly, and improving the success rate of the surgery.

[0033] Since the electrode wire and electrode wire delivery system provided by this invention belong to the same inventive concept as the electrode wire head end structure provided by this invention, the electrode wire and electrode wire delivery system provided by this invention have at least all the advantages of the electrode wire head end structure provided by this invention, which will not be elaborated here. Attached Figure Description

[0034] Figure 1 This is a schematic diagram of the structure of the electrode wire provided in Embodiment 1 of the present invention;

[0035] Figure 2 This is a schematic diagram of the transfer sheath of the electrode wire delivery system provided in Embodiment 2 of the present invention;

[0036] Figure 3 This is a schematic diagram of the overall structure of the electrode lead end structure provided in Embodiment 3 of the present invention;

[0037] Figure 4A This is a schematic diagram of the overall structure of the transition hose of the flexible transition unit of the electrode wire end structure provided in one embodiment of the third embodiment of the present invention.

[0038] Figure 4B for Figure 4A A schematic diagram of the structure in which the connecting wire is inserted into the middle two-stage transition hose;

[0039] Figure 4C for Figure 4A A front view of the object in a bent state;

[0040] Figure 5A This is a schematic diagram showing the connection of the ring electrode, connecting wire, second support member, and fixing unit in their natural state in one embodiment of the present invention.

[0041] Figure 5B for Figure 5A A schematic diagram of a connection that undergoes bending deformation under external force;

[0042] The reference numerals in the attached figures are explained as follows:

[0043] Connector end-100, conductor body-200, electrode conductor tip structure-300;

[0044] First support unit-310, hollow insulating structure-311, first insulating component-3111, first support component-3112, ring electrode-312;

[0045] Flexible transition unit-320, transition hose-321, connecting wire-322, connecting hole-323;

[0046] Second support unit-330, second insulating component-331, second support component-332;

[0047] Fixing unit-340, fixing head-341, fixing screw-342;

[0048] Drive electrical connection unit-350, drive screw-351, telescopic pin-352, connector-353;

[0049] Sheath inlet -410, first bend -420, second bend -430, sheath outlet -440;

[0050] Central angle -α. Detailed Implementation

[0051] To make the objectives, advantages, and features of the present invention clearer, the electrode lead end structure, electrode lead, and electrode lead delivery system proposed in this invention will be further described in detail below with reference to the accompanying drawings. It should be noted that the drawings are all in a very simplified form and use non-precise proportions, and are only used to facilitate and clarify the illustration of the embodiments of the present invention. It should be understood that the accompanying drawings do not necessarily show the specific structure of the invention to scale, and the illustrative features used to illustrate certain principles of the invention in the accompanying drawings are also drawn in a slightly simplified manner. Specific design features of the invention disclosed herein, including, for example, specific dimensions, orientations, positions, and shapes, will be determined in part by the specific application and environment in which they are used. Furthermore, in the embodiments described below, the same reference numerals are sometimes used across different drawings to denote the same parts or parts having the same function, and their repeated descriptions are omitted. In this specification, similar reference numerals and letters are used to denote similar items; therefore, once an item is defined in one drawing, it does not need to be further discussed in subsequent drawings.

[0052] Where appropriate, these terms may be replaced. Similarly, if the methods described herein comprise a series of steps, and the order of these steps presented herein is not necessarily the only possible order in which these steps can be performed, and some of the described steps may be omitted and / or some other steps not described herein may be added to the method.

[0053] The core idea of ​​this invention is to provide an electrode lead tip structure, an electrode lead, and an electrode lead delivery system. The electrode lead tip structure of this invention adopts a multi-segment, flexible and rigid design, which makes it easier for the operator to manipulate the electrode lead tip structure through the delivery sheath, reducing the time required for surgical operations, thereby reducing the risk of infection for the patient, enabling the surgery to proceed smoothly, and improving the success rate of the surgery.

[0054] To realize the above ideas and facilitate a better understanding of the present invention, the following embodiments are described one by one in the order of electrode leads, delivery sheaths, and electrode lead tip structures. It should be further noted that the proximal end referred to herein is the end closer to the operator (i.e., the end furthest from the lesion or target organ tissue), and the distal end referred to herein is the end furthest from the operator (i.e., the end closer to the lesion or target organ tissue). Furthermore, as those skilled in the art will understand, the present invention does not limit the use of the electrode leads, which can be used for purposes including but not limited to cardiac pacing, ablation therapy, or physiological signal acquisition.

[0055] Example 1

[0056] One embodiment of the present invention provides an electrode wire; specifically, please refer to [link to relevant documentation]. Figure 1 The diagram illustrates the structure of an electrode wire provided in one embodiment of the present invention. Figure 1 As will be understood by those skilled in the art, the present invention simplifies the electrode wire to a connection end 100, a wire body 200, and an electrode wire tip structure 300. The connection end 100, the wire body 200, and the electrode wire tip structure 300 are sequentially fixedly connected from the proximal end to the distal end along the extension direction of the electrode wire. More specifically, the electrode wire tip structure 300 provided in this embodiment is the electrode wire tip structure 300 described in any of the following embodiments. For more detailed information regarding the electrode wire tip structure 300, please refer to the relevant description below; to avoid redundancy, it will not be elaborated upon here.

[0057] Furthermore, since the electrode lead provided by this invention and the electrode lead tip structure 300 provided in the following embodiments belong to the same inventive concept, the electrode lead provided in this embodiment is also easier for the operator to manipulate through the electrode lead tip structure 300 via the delivery sheath, reducing the time required for surgical operations, thereby reducing the risk of patient infection, enabling the surgery to proceed smoothly, and improving the success rate of the surgery. In other words, the electrode lead provided in this embodiment has at least all the advantages of the electrode lead tip structure 300 provided in the following embodiments. For more detailed information on the advantages of the electrode lead tip structure 300 provided in the various embodiments of this invention, please refer to the relevant description below, which will not be elaborated here.

[0058] Example 2

[0059] This embodiment provides an electrode lead delivery system, which includes a delivery sheath and electrode leads. The delivery sheath is used to deliver the electrode leads to a target location in a target organ or tissue. Specifically, the delivery sheath of the electrode lead delivery system provided in this embodiment will be described below. For details regarding the electrode leads of the electrode lead delivery system provided in this embodiment, please refer to Embodiment 1 above. To avoid redundancy, further description will not be provided here.

[0060] To better understand this embodiment, before specifically describing the delivery sheath provided in this embodiment, it should be noted that, as those skilled in the art will understand, delivery sheaths sometimes need to be designed with a curved shape to accommodate different human anatomical structures. Therefore, when a delivery sheath with a certain degree of curvature is used to deliver electrode leads, if the electrode lead tip structure is designed with a flexible or rigid approach, it will lead to problems as described in the background art, such as the electrode leads being unable to pass through the delivery sheath or being easily damaged.

[0061] For example, please see Figure 2 The diagram schematically illustrates the structure of the transfer sheath of the electrode wire delivery system provided in this embodiment. Figure 2 As can be seen, the transfer sheath of the electrode lead delivery system provided in this embodiment includes a sheath inlet 410, a tube body (not shown in the figure), and a sheath outlet 440, and the tube body includes at least one bend. With this configuration, the transfer pin of the electrode lead delivery system provided in this embodiment can be better adapted to the structures of different target organ tissues.

[0062] Preferably, please continue to see Figure 2 In one exemplary embodiment, the transfer sheath includes a first bend 420 and a second bend 430, both of which are located near the distal end of the transfer sheath; further, the first bend 420 (large bend) has a first bending angle 510 greater than the second bend 430 (small bend); even further, the second bend 430 is located further near the distal end of the transfer sheath relative to the first bend 420; still further, both the first bend 420 and the second bend 430 are in a counterclockwise direction (with... Figure 2 When the delivery sheath is positioned as shown, it is bent so that the distal end of the delivery sheath forms a fishhook shape. This "fishhook" shaped delivery sheath allows for secondary redirection within the target organ tissue, making it easier for doctors to operate.

[0063] Furthermore, in some other preferred embodiments, the bending angles of the first bend 420 and the second bend 430 of the delivery sheath are adjustable, that is, the delivery sheath has an adjustable bending function. This makes it easier for the operator (such as a doctor) to adjust the distal end of the delivery sheath to different angles inside the patient's body through external adjustment, thereby further adapting to the anatomical structure of different target organs and tissues.

[0064] It should be noted that, as those skilled in the art will understand, this invention does not limit the number of bends in the transfer sheath, the specific location of each bend on the tube body, the bending angle of each bend, or the bending direction. In practical applications, these should be reasonably set according to actual needs. It is understood that, preferably, the bending angle of each bend in the transfer sheath and the distance between adjacent bends should be adapted to the length and bendable range (i.e., the range of the central angle corresponding to the flexible transition unit 320 when the flexible transition unit 320 is under force) of the electrode lead tip structure 300. This better protects the electrode lead and facilitates the operator's manipulation of the electrode lead tip structure 300 through the transfer sheath, reducing the time required for surgical operations, improving surgical efficiency, and alleviating patient pain.

[0065] Example 3

[0066] This embodiment provides an electrode lead end structure 300. For details, please refer to [link to documentation]. Figure 3 The diagram schematically illustrates the overall structure of the electrode lead end structure provided in this embodiment. From... Figure 3 As can be seen, the electrode lead end structure 300 provided in this embodiment includes a first support unit 310, a flexible transition unit 320, a second support unit 330, a fixing unit 340, and a driving electrical connection unit 350. More specifically, along the extension direction of the electrode lead end structure 300 from the proximal end (left side in the illustrated direction) to the distal end (right side in the illustrated direction), the first support unit 310, the flexible transition unit 320, the second support unit 330, and the fixing unit 340 are sequentially fixedly connected to form a cavity (not shown in the figure); the two ends of the cavity respectively penetrate the proximal end and the distal end of the electrode lead end structure 300. The driving electrical connection unit 350 is at least partially located within the cavity. The first support unit 310 includes a rigid hollow insulating structure 311; the flexible transition unit 320 is configured to bend when an external force is applied and to return to its original shape after the external force is removed.

[0067] Therefore, the electrode lead end structure 300 provided in this embodiment adopts a multi-segment, flexible-rigid combination design with a first support unit 310, a flexible transition unit 320, and a second support unit 330. The first support unit 310 is rigid, the flexible transition unit 320 can bend under external force, and the second support unit 330 is rigid. When the operator passes the electrode lead end structure 300 through the curved transmission sheath, the flexible transition unit 320 of the electrode lead end structure 300 can bend and deform under force, which can reduce the resistance encountered by the electrode lead in the transmission sheath. This makes it easier for the electrode lead to pass smoothly through the curved transmission sheath when implanting the electrode lead. Furthermore, when rotating to implant the electrode lead, the first support unit 310, the flexible transition unit 320, and the second support unit 330 of the electrode lead end structure 300 provided in this embodiment can meet the requirements of torsional resistance and rigid support, as well as bending deformation. In summary, the electrode lead tip structure 300 provided in this embodiment is not only simple in structure, but also solves the problem that the rigid electrode tip of the electrode lead is difficult to pass through the curved sheath, and solves the problem that the flexible electrode tip is easy to twist and deform and cannot provide anti-torsion and support. It is easier for the operator to manipulate the electrode lead tip structure 300 through the sheath, reducing the time required for surgical operation, thereby reducing the risk of infection for the patient, enabling the operation to proceed smoothly, and improving the success rate of the operation.

[0068] In some exemplary embodiments, the drive electrical connection unit 350 includes a drive unit and a telescopic pin; the drive unit is disposed within the cavity, and the distal end of the drive unit is connected to the proximal end of the telescopic pin 352; the drive unit is configured to drive the telescopic pin 352 along the extension direction of the electrode lead end structure (i.e., Figure 3 The drive electrical connection unit 350 is partially located within the cavity, comprising: the drive unit is located within the cavity, a portion of the telescopic pin 352 is located within the cavity, and the other portion of the telescopic pin 352 is located outside the cavity. More specifically, as those skilled in the art will understand, the present invention does not limit the specific form of the drive unit. Preferably, the drive unit is a drive screw 351, and the inner wall of the cavity is provided with an internal thread to match the drive screw 351. When the drive screw 351 rotates around its own axis, under the action of the internal thread, the drive screw 351 and the telescopic pin 352 are driven synchronously along the extension direction of the electrode wire head structure (i.e., the direction of extension). Figure 3 Move in the left or right direction as shown.

[0069] Preferably, please continue to see Figure 3The first support unit 310, the flexible transition unit 320, the second support unit 330, and the fixing unit 340 are hollow cylinders or hollow quasi-cylinders with collinear central axes (in the natural state of the flexible transition unit 320, i.e., when the flexible transition unit 320 is not under external force). Therefore, by designing the first support unit 310, the flexible transition unit 320, the second support unit 330, and the fixing unit 340 as cylindrical or quasi-cylinder shapes, the cylindrical or quasi-cylinder structure facilitates the delivery sheath in transporting the electrode wire with the electrode wire tip structure 300 provided in this embodiment to the target location in the target organ tissue. Simultaneously, the collinear central axes of the cavity formed by the first support unit 310, the flexible transition unit 320, the second support unit 330, and the fixing unit 340, and the cylindrical structure of the cavity, also facilitate the drive unit in driving the telescopic needle 360 ​​to move along the extension direction of the electrode wire tip structure 300. Furthermore, the central axis of the driving unit and the telescopic needle 360 ​​is collinear with the central axis of the first support unit 310, the flexible transition unit 320, the second support unit 330 and the fixing unit 340, thereby further facilitating the driving unit to drive the telescopic needle 360 ​​to move along the extension direction of the electrode lead end structure 300.

[0070] It should be noted that, as those skilled in the art will understand, the first support unit 310, the flexible transition unit 320, the second support unit 330, and the fixing unit 340 being hollow cylinders or hollow quasi-cylinders with collinear central axes are merely preferred embodiments and not limitations of the present invention. In other embodiments, the shapes of the first support unit 310, the flexible transition unit 320, the second support unit 330, and the fixing unit 340 may also be other non-cylindrical shapes, such as polygonal prisms, ellipses, etc.

[0071] Preferably, the diameter (outer diameter) of the electrode lead end structure 300 is in the range of 1mm to 3mm, and the length of the electrode lead end structure 300 is in the range of 5mm to 50mm. Therefore, setting the outer diameter of the electrode lead end structure 300 within the range of 1mm to 3mm avoids both excessively large outer diameters that would hinder the delivery of the sheath and excessively small outer diameters that would further impede the cavity of the electrode lead end structure 300, making it difficult for the drive unit to drive the telescopic needle to reciprocate along the extension direction of the electrode lead end structure 300. Setting the length of the electrode lead end structure 300 within the range of 5mm to 50mm ensures that the lengths of the first support unit 310, flexible transition unit 320, second support unit 330, and fixing unit 340 are appropriate, thus guaranteeing the rigidity and flexibility of the electrode lead end structure 300. This avoids both excessively short lengths that would result in insufficient rigidity and flexibility, and excessively long lengths that would prevent damage to the electrode lead due to the inability to adapt to closely spaced bends in the delivery conduit.

[0072] Preferably, please continue to see Figure 3 The first support unit 310 further includes a ring electrode 312 disposed on the outer periphery of the rigid hollow insulating structure 311; the rigid hollow insulating structure 311 of the first support unit 310 includes a first insulating member 3111 and a first supporting member 3112, both of which are annular; wherein, the first insulating member 3111 is located between the ring electrode 312 and the first supporting member 3112, and the ring electrode 312, the first insulating member 3111 and the first supporting member 3112 are sequentially and coaxially fixedly connected; the ring electrode 312 is connected to the flexible transition unit 340. With this configuration, the first insulating member 3111 can separate the driving screw 351 and the ring electrode 312, not only preventing the ring electrode 312 from being electrically connected to the telescopic needle 352 (which is made of conductive material and used as an electrode, and is conductive), thus achieving mutual insulation between the external ring electrode 312 and the internal telescopic needle 352; but also, the first supporting member 3112 is a rigid hollow insulating structure, achieving effective support for the first insulating member 3111 and the ring electrode 312. Therefore, it can be ensured that the proximal end of the electrode lead end structure 300 has good insulation and rigidity.

[0073] More specifically, in one preferred embodiment, the ring electrode 312, the first insulating member 3111, and the first supporting member 3112 are tightly fitted and coaxially fixedly connected. Furthermore, the ring electrode 312 is seamlessly fixedly connected to the flexible transition unit 320. Thus, this layered design further ensures the rigidity of the proximal end of the electrode lead end structure 300, thereby facilitating the placement of the driving unit along with the telescopic needle 352 within the cavity.

[0074] It should be noted that, as those skilled in the art will understand, the design of the coaxial fixed connection of the ring electrode 312, the first insulating member 3111, and the first supporting member 3112 in close contact described above is merely an illustrative example and not a limitation of the present invention. Furthermore, the material of the first insulating member 3111 is preferably silicone, polyurethane, polypropylene, etc., and the first supporting member 3112 is preferably PVC, PEEK, polyethylene, etc.

[0075] Preferably, please refer to Figures 4A-4C and Figures 5A-5B ,in, Figure 4A This is a schematic diagram of the overall structure of the transition hose 321 of the flexible transition unit 320 of the electrode wire end structure 300 provided in one embodiment of the present invention. Figure 4B for Figure 4A A schematic diagram of the structure in which the connecting wire 322 is inserted into the transition hose 321 in the middle section; Figure 4C for Figure 4A A front view of the object in a bent state; Figure 5A This is a schematic diagram showing the natural connection of the ring electrode 312, connecting wire 322 (transition hose 321 is not shown in the figure for easy observation), second support member 332 and fixing unit 340 of the electrode lead end structure 300 provided in one embodiment of the present invention. Figure 5B for Figure 5A A schematic diagram of a connection that undergoes bending deformation under external force. Figures 4A-4CAs can be seen, the flexible transition unit 320 includes a transition hose 321 and at least one connecting wire 322. The transition hose 321 includes connecting holes 323 corresponding one-to-one with the number of connecting wires 322. The connecting holes 323 penetrate the tube body of the transition hose 321 along the axial direction of the transition hose 321. The length of the connecting wire 322 is greater than the length of the transition hose 321. The connecting wire 322 passes through the connecting holes 323, and the proximal end of at least one connecting wire 322 is fixedly connected to the ring electrode 312. The distal end of the connecting wire 322 fixedly connected to the ring electrode 312 is connected to the second support unit 330 (e.g., the fixing head 341 of the fixing unit 340). The transition hose 321 and the connecting wire 322 are configured to be able to bend when an external force is applied and to return to their original shape after the external force is removed. This configuration, combining rigidity and flexibility, allows the electrode lead end structure 300 to be both torsional and rigid, while also allowing it to be bent. This makes it easier for the operator to manipulate the electrode lead end structure 300 through the transfer sheath, reducing the risk of damage to the electrode lead end structure 300 when the electrode lead is transported through the transfer sheath.

[0076] It should be noted that, as those skilled in the art will understand, the present invention does not limit the materials of the transition hose 321 and the connecting wire 322. The transition hose 321 can be made of an elastic soft material that can bend under external force; and after being inserted into the connecting wire 322, it can also bend together with the connecting wire 322 under the action of external force; furthermore, after the external force is removed, the bent and deformed transition hose 321 and the connecting wire 322 can return to their original shape. Preferably, the material of the transition hose 321 is silicone or polyurethane.

[0077] In one exemplary embodiment, there are at least two connecting holes 323 (as previously stated, the number of connecting holes 323 corresponds one-to-one with the number of connecting wires 322, and will not be repeated below); the plurality of connecting holes 323 are evenly distributed along the circumference of the transition hose 321; preferably, the shape of the connecting holes 323 includes cylinders, triangular prisms, or polygonal prisms. Thus, the even distribution of connecting holes 323 along the circumference of the transition hose 321 allows for more uniform stress distribution on the ring electrode 312, the transition hose 321, and the second support unit 330 when the transition hose 321 undergoes bending deformation, ensuring that the electrode lead end structure 300 only bends without twisting. Furthermore, the transition hose 321 with a uniformly distributed plurality of connecting holes 323 has better stability compared to a transition hose 321 with only one connecting hole 323. Further, the design of the connecting holes 323 as cylinders, triangular prisms, or polygonal prisms facilitates the insertion of the connecting wires 322. It should be noted that the present invention does not limit the number of connecting holes 323 or the number of connecting wires 322. Preferably, the number of connecting wires 322 is equal to or greater than the number of connecting holes 323. For example, one connecting wire 322 can be provided in one connecting hole 323, and multiple connecting wires 322 can also be provided in one connecting hole. More preferably, the number of connecting wires 322 is equal to the number of connecting holes 323. As in this embodiment, there are four connecting wires 322 and four connecting holes 323.

[0078] In some exemplary embodiments, the shape of the connecting hole 323 includes a cylindrical structure with a diameter ranging from 0.02 mm to 0.3 mm, a triangular prism with a cross-sectional side length ranging from 0.02 mm to 0.3 mm, or a polygonal prism with a cross-sectional diagonal length ranging from 0.02 mm to 0.3 mm. This design facilitates the insertion of the connecting wire 322 without adversely affecting the strength and flexibility of the transition hose 321.

[0079] Please see Figure 4C In one exemplary embodiment, when an external force is applied to the transition hose 321 and the connecting wire 322, the central angle α corresponding to the transition hose 321 subjected to the external force ranges from 45° to 180° (i.e., 45° ≤ α ≤ 180°). That is, the degree of curvature of the transition hose 321 varies between no curvature (where the angle between the line connecting the distal and proximal ends of the transition hose 321 is 180°, i.e., the transition hose 321 is straight) and maximum curvature (where the central angle corresponding to the curvature of the transition hose 321, i.e., the angle between the cross-sections at the proximal and distal ends, is 45°). This arrangement ensures that the electrode wires can pass smoothly through the curved transmission sheath without affecting the reciprocating movement of the drive electrical connection unit 350 within the cavity.

[0080] In one exemplary embodiment, the outer diameter of the transition hose 321 ranges from 1.5 mm to 3 mm; the length of the transition hose 321 ranges from 2 mm to 20 mm.

[0081] It should be noted that, as those skilled in the art will understand, the specific dimensions of the connecting hole 323 and the range of the first bending angle 510 of the transition hose 321 and the connecting wire 322 when an external force is applied should be reasonably set according to actual needs, and the present invention does not limit this.

[0082] Please continue reading Figure 3 In one preferred embodiment, the second support unit 330 includes a second insulating member 331 and a second support member 332 coaxially fixedly connected. Both the second insulating member 331 and the second support member 332 are annular, and the second support unit 330 is a rigid hollow insulating structure. The second support member 332 is sleeved on the outer periphery of the second insulating member 331. The second support member 332 is fixedly connected to the flexible transition unit 320. This configuration ensures that the electrode lead end structure 300 has good insulation and rigidity. Further, the second insulating member 331 and the second support member 332 are coaxially fixedly installed and seamlessly connected. It should be noted that the design of the second insulating member 331 and the second support member 332 being coaxially fixedly installed and seamlessly connected is merely illustrative and not a limitation of the present invention. Further, the material of the second insulating member 331 is preferably silicone, polyurethane, or polypropylene, and the material of the second support member 332 is preferably PVC, PEEK, or polyethylene.

[0083] More specifically, the distal ends of several connecting wires 322 are fixedly connected to the proximal end of the second support member 332, and correspondingly, the proximal ends of the connecting wires 322 fixedly connected to the proximal end of the second support member 332 are connected to the ring electrode 312. Further, it should be noted that, as mentioned above, the telescopic needle 352 is made of conductive material and used as an electrode. Preferably, the cross-sectional shape of the second insulating member 331 along its axial direction is preferably a horizontally placed L-shape. Specifically, along the extension direction (e.g. Figure 3 The first part (long side of the L-shape) of the second insulating member 331 (shown in the left-right direction) can prevent the telescopic needle 352 from being electrically connected to the ring electrode 312 via the connecting wire 322 provided in the transition hose 321; along the direction perpendicular to the extension (e.g. Figure 3 The second part (short side of the L-shape) of the second insulating member 331 (shown in the up-down direction) can prevent the fixing unit 340 from being electrically connected to the ring electrode 312 via the connecting wire 322 provided in the transition hose 321.

[0084] Please continue reading Figure 3 In one exemplary embodiment, the fixing unit 340 includes a fixing head 341 and a fixing screw 342; the proximal end of the fixing head 341 is connected to the second support unit 330 (specifically...). Figure 3 The distal end of the second insulating member 331 (shown) is fixedly connected, and the fixing screw 342 is fixed to the distal end of the fixing head 341; the telescopic needle 352 passes through the fixing head 341 and the fixing screw 342, and the central axes of the telescopic needle 352, the fixing head 341, and the fixing screw 342 are collinear. Therefore, driven by the driving screw 351, the telescopic needle 352 can more easily penetrate the target location of the target organ tissue, thereby implanting the electrode wire into the target location of the target organ tissue through the fixation of the fixing screw 342. It should be noted that the telescopic needle 352 is preferably made of a pointed metal material and is located on the central axis of the electrode wire tip structure 300, thereby facilitating the driving of the driving screw 351 to smoothly penetrate the target location of the target organ tissue.

[0085] Please continue reading Figure 3 In one preferred embodiment, the electrode lead end structure 300 further includes a connector 353 connecting the driving unit and the telescopic needle 352. The connector 353 is located within the cavity corresponding to the second support unit 330 and can slide along the inner wall of the second support unit 330. By providing the connector 353 between the driving unit (e.g., the driving screw 351) and the telescopic needle 352, the robustness of the connection between the driving unit and the telescopic needle 352 can be further ensured; moreover, it can also provide axial guidance for the movement of the telescopic needle 352. Furthermore, the fact that the connector 353 is located within the rigid cavity corresponding to the second support unit 330 makes it easier for the operator to insert the telescopic needle 352 into the target location of the target organ tissue; even further, the fact that the connector 353 can slide along the inner wall of the second support unit 330 ensures the stability of the telescopic needle 352 during movement.

[0086] To better understand the present invention, the following is a general description of the method for delivering a device having the electrode lead tip structure 300 provided by the present invention to a target organ tissue using the delivery sheath provided by the present invention:

[0087] In one exemplary implementation, the operator can first insert the electrode wire body 200 and the electrode wire tip structure 300 into the transmission sheath through the sheath inlet 410; and move the electrode wire sequentially through the first bend 420 and the second bend 430 until the electrode wire tip 300 is partially or completely exposed outside the sheath outlet 440. Combined with... Figure 2 and Figure 5BIt is understood that, since the central axis of the transfer sheath (as those skilled in the art will understand, the transfer sheath is a hollow structure capable of accommodating the electrode wire) is not entirely a straight line, but rather a multi-segment curved line, and since the length of the electrode wire tip structure 300 is relatively long, during the insertion of the electrode wire, the inner wall of the transfer sheath exerts a significant reaction force on the electrode wire tip structure 300, hindering the electrode wire tip structure 300 from passing through the transfer sheath. This causes the flexible transition unit 320 of the electrode wire tip structure 300 to bend and deform under stress. After bending and deforming under force, the first circle center... Angle α passes through the sheath until the electrode lead tip structure 300 exposes the sheath outlet 440. Finally, the electrode lead is twisted. During the twisting process, the assembly consisting of multiple connecting wires 322, the ring electrode 312, and the second support member 332 provides axial support and anti-torsional support. The fixing screw 342 rotates into the target organ tissue (e.g., myocardium), and then the rotating driving screw 351 causes the telescopic needle 352 to pierce the target location (e.g., left bundle branch) of the target organ tissue (e.g., myocardium) until the electrode lead is successfully implanted and fixed at the target location of the target organ tissue. It should be specifically noted that, as those skilled in the art will understand, the present invention does not limit the target location of the telescopic needle 352 of the electrode lead or the function of the electrode lead. In other embodiments, the electrode lead can also be fixed in the interventricular septum, atrial wall, etc. The electrode lead implanted at the target location can be used to sense the physiological information of the target organ tissue or to pace (stimulate) the target organ tissue to enable it to function normally.

[0088] It should be understood that in the description of this invention, the terms "center," "longitudinal," "lateral," "length," "width," "thickness," "upper," "lower," "front," "rear," "left," "right," "vertical," "horizontal," "top," "bottom," "inner," "outer," "clockwise," "counterclockwise," "axial," "radial," and "circumferential" indicate the orientation or positional relationship based on the orientation or positional relationship shown in the accompanying drawings. They are used only for the convenience of describing this invention and simplifying the description, and do not indicate or imply that the device or element referred to must have a specific orientation, or be constructed and operated in a specific orientation. Therefore, they should not be construed as limitations on this invention.

[0089] Furthermore, the terms "first" and "second" are used for descriptive purposes only and should not be construed as indicating or implying relative importance or implicitly specifying the number of technical features indicated. Thus, a feature defined as "first" or "second" may explicitly or implicitly include at least one of that feature. In the description of this invention, "a plurality of" means at least two, such as two, three, etc., unless otherwise explicitly specified.

[0090] In this invention, unless otherwise explicitly specified and limited, the terms "installation," "connection," "linking," and "fixing," etc., should be interpreted broadly. For example, they can refer to a fixed connection, a detachable connection, or an integral part; they can refer to a mechanical connection or an electrical connection; they can refer to a direct connection or an indirect connection through an intermediate medium; they can refer to the internal communication of two components or the interaction between two components, unless otherwise explicitly limited. Those skilled in the art can understand the specific meaning of the above terms in this invention according to the specific circumstances.

[0091] In this invention, unless otherwise explicitly specified and limited, "above" or "below" the second feature can mean that the first feature is in direct contact with the second feature, or that the first feature is in indirect contact with the second feature through an intermediate medium. Furthermore, "above," "over," and "on top" of the second feature can mean that the first feature is directly above or diagonally above the second feature, or simply that the first feature is at a higher horizontal level than the second feature. "Below," "below," and "under" the second feature can mean that the first feature is directly below or diagonally below the second feature, or simply that the first feature is at a lower horizontal level than the second feature.

[0092] In the description of this specification, the references to terms such as "one embodiment," "some embodiments," "example," "specific example," or "some examples," etc., indicate that a specific feature, structure, material, or characteristic described in connection with that embodiment or example is included in at least one embodiment or example of the present invention. In this specification, the illustrative expressions of the above terms do not necessarily refer to the same embodiment or example. Furthermore, the specific features, structures, materials, or characteristics described may be combined in any suitable manner in one or more embodiments or examples. Moreover, without contradiction, those skilled in the art can combine and integrate the different embodiments or examples described in this specification, as well as the features of different embodiments or examples.

[0093] In summary, the above embodiments have provided detailed descriptions of different configurations of the electrode lead end structure, electrode lead, and electrode lead delivery system proposed in this invention. Of course, the above descriptions are only descriptions of preferred embodiments of this invention and are not intended to limit the scope of this invention in any way. This invention includes, but is not limited to, the configurations listed in the above embodiments. Those skilled in the art can draw inferences from the above embodiments. Any changes or modifications made by those skilled in the art based on the above disclosure are within the scope of protection of the claims.

Claims

1. An electrode lead end structure, characterized in that, include: The system comprises a first support unit, a flexible transition unit, a second support unit, a fixing unit, and a drive electrical connection unit. Along the extension direction from the proximal end to the distal end of the electrode lead end structure, the first support unit, the flexible transition unit, the second support unit, and the fixing unit are sequentially connected to form a cavity; the two ends of the cavity respectively penetrate the proximal end and the distal end of the electrode lead end structure; wherein, the proximal end is the end closer to the operator, and the distal end is the end farther away from the operator; The drive electrical connection unit is located at least partially within the cavity; The first support unit includes a rigid hollow insulating structure through which the drive electrical connection unit passes and a ring electrode disposed on the outer periphery of the rigid hollow insulating structure. The flexible transition unit includes a transition hose and at least one connecting wire. The transition hose includes connecting holes that correspond one-to-one with the number of connecting wires. The connecting holes penetrate the tube body of the transition hose along the axial direction of the transition hose. The length of the connecting wire is greater than the length of the transition hose. The connecting wire passes through the connecting hole, and the proximal end of at least one connecting wire is fixedly connected to the ring electrode, while the distal end of the connecting wire fixedly connected to the ring electrode is connected to the second support unit. The transition hose and the connecting wire are configured to bend when an external force is applied and to return to their original shape after the external force is removed.

2. The electrode lead end structure according to claim 1, characterized in that, The first support unit, the flexible transition unit, the second support unit, and the fixing unit are hollow cylinders or hollow quasi-cylinders with collinear central axes.

3. The electrode lead end structure according to claim 1, characterized in that, The rigid hollow insulating structure of the first support unit includes a first insulating element and a first support element, both of which are annular. The first insulating element is located between the annular electrode and the first support element, and the annular electrode, the first insulating element, and the first support element are sequentially and coaxially fixedly connected. The annular electrode is connected to the flexible transition unit.

4. The electrode lead end structure according to claim 1, characterized in that, The connection holes are at least two in number; a plurality of the connection holes are evenly distributed along the circumference of the tube body of the transition hose; and / or the shape of the connection holes includes a cylinder, a triangular prism, or a polygonal prism.

5. The electrode lead end structure according to claim 1, characterized in that, When an external force is applied to the transition hose and the connecting wire, the angle of the central angle of the transition hose subjected to the external force ranges from 45° to 180°.

6. The electrode lead end structure according to claim 1, characterized in that, The second support unit includes a second insulating member and a second support member fixedly connected coaxially. Both the second insulating member and the second support member are annular bodies, and the second support unit is a rigid hollow insulating structure. The second support member is sleeved on the outer periphery of the second insulating member. The second support member is fixedly connected to the flexible transition unit.

7. The electrode lead end structure according to any one of claims 1-6, characterized in that, The drive electrical connection unit includes a drive unit and a telescopic pin; the drive unit is disposed in the cavity, and the distal end of the drive unit is connected to the proximal end of the telescopic pin. The drive unit is configured to drive the telescopic needle to move along the extension direction of the electrode lead end structure.

8. The electrode lead end structure according to claim 7, characterized in that, The fixing unit includes a fixing head and a fixing screw; The proximal end of the fixing head is fixedly connected to the distal end of the second support unit, and the fixing screw is fixed to the distal end of the fixing head and extends in a direction away from the second support unit. The telescopic needle passes through the fixed head, and under the drive of the drive unit, the distal end of the telescopic needle can move from the fixed head to the distal end of the fixed screw. The central axes of the telescopic needle, the fixed head, and the fixed screw are collinear.

9. The electrode lead end structure according to claim 7, characterized in that, The drive electrical connection unit further includes a connector that connects the drive unit and the telescopic pin. The connector is located in the cavity corresponding to the second support unit and can slide along the inner wall of the second support unit.

10. An electrode wire, characterized in that, It includes a connection end, a conductor body, and an electrode conductor head structure as described in any one of claims 1-9, which are sequentially connected along the direction from the proximal end to the distal end of the electrode conductor.

11. An electrode wire delivery system, characterized in that, Includes a delivery sheath and the electrode wires as described in claim 10; The transmission pin tube includes a sheath inlet, a tube body, and a sheath outlet, and the tube body includes at least one bend; The delivery sheath is used to deliver the electrode wires to the target location in the target organ tissue.

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