Electrode lead guiding sheath

Abstract

The utility model relates to the technical field of cardiovascular intervention. The utility model provides an electrode wire guiding sheath. The electrode wire guiding sheath comprises a handle provided with a bending adjusting piece and a sheath tube body. The near end of the sheathing canal body is connected with the handle, a bending adjusting steel wire channel extending from the near end to the far end is arranged in the canal wall of the sheathing canal body, the bending adjusting steel wire is arranged in the bending adjusting steel wire channel, and the bending adjusting steel wire is connected with a bending adjusting piece of the handle at the near end of the sheathing canal body so that bending of the bending adjusting steel wire can be adjusted through the bending adjusting piece. A tearing line groove extending from the near end to the far end is further formed in the pipe wall of the sheathing pipe body, and the tearing line groove and the bending adjusting steel wire channel do not coincide. According to the guide sheath, the electrode wire can be shaped through the bending adjusting piece and the bending adjusting steel wire, meanwhile, the tearing line groove is formed in the tube wall of the sheath tube body, the tearing line groove and the bending adjusting steel wire do not interfere with each other, and the sheath tube body can be conveniently withdrawn after the electrode wire is implanted into the heart.

Description

Technical Field

[0001] This application relates to the field of cardiovascular interventional technology, and in particular to an electrode lead guide sheath. Background Technology

[0002] Electrode leads have a wide range of applications, including in cardiac pacemakers. A cardiac pacemaker is an implantable electronic therapeutic device. Electrical pulses generated by an external pulse generator are conducted through electrode leads to electrodes inside the body, stimulating the myocardium in contact with the electrodes, causing the heart to beat and contract, thereby treating cardiac dysfunction caused by certain arrhythmias. In this process, how the electrode leads are implanted into the patient's heart is a crucial step. Utility Model Content

[0003] This application provides an electrode wire guiding sheath, comprising:

[0004] A handle, wherein a bending adjustment element is provided on the handle; and

[0005] The sheath body, the proximal end of which is connected to the handle.

[0006] The sheath body has an adjusting wire channel extending from its proximal end to its distal end within its tube wall. The adjusting wire is placed within this channel and is connected to an adjusting component of the handle at its proximal end, allowing the bending of the adjusting wire to be adjusted via the adjusting component.

[0007] The sheath body also has a tear groove extending from the proximal end to the distal end of the sheath body on its tube wall.

[0008] Furthermore, the sheath body has two or four bending wire channels inside its tube wall, and one or two tear grooves on its tube wall.

[0009] Furthermore, the electrode wire guiding sheath also includes a head end tube, which is connected to the sheath body at the distal end of the sheath body, and the material of the head end tube is softer than the material of the sheath body.

[0010] Furthermore, a balloon is provided on the outer wall of the head end tube, and the balloon is hollow or made of an ultrasound-detectable material.

[0011] Furthermore, a radiopaque ring made of ultrasonic radiopaque material is provided on the inner wall of the head end tube or sheath body.

[0012] Furthermore, the electrode wire guiding sheath also includes a clamping device disposed on the sheath body, which expands toward the cavity of the sheath body when pressurized.

[0013] Furthermore, the clamping device is a cavity, a balloon, a spring, or a polymer material.

[0014] Furthermore, the electrode wire guiding sheath also includes:

[0015] An inner sheath includes an inner sheath tube body and an inner sheath handle connected to the proximal end of the inner sheath tube body. The inner sheath handle is disposed at the proximal end of the handle. The inner sheath tube body is disposed within the lumen of the sheath tube body and extends out of the sheath tube body from its distal end.

[0016] The inner sheath body has a tear groove on its wall extending from the proximal end to the distal end of the inner sheath body.

[0017] Furthermore, the inner wall diameter at the head end of the inner sheath body gradually decreases from the proximal end to the distal end, and the head end opening of the inner sheath is provided with multiple slots extending along the direction of the inner sheath body.

[0018] Furthermore, the electrode wire guiding sheath also includes: an electrode rotation device.

[0019] The electrode rotating device includes:

[0020] A fixed rotating device, connected to the handle, is used to fix the handle and the sheath body, and the rotation of the fixed rotating device drives the handle, the sheath body, and the electrode wires inside the sheath body to rotate; and

[0021] An electrode clip pair includes two parallel electrode clips, which are fixedly arranged and used to clamp the electrode of the electrode wire. Each electrode clip of the electrode clip pair is used to connect to a multiconductor via a wire.

[0022] According to the above-described embodiments of this application, a bending wire is provided inside the wall of the sheath body. The bending of the bending wire is controlled by the bending member on the handle, thereby causing the sheath body to bend. This allows for convenient shaping of the sheath body and the electrode wire to be placed inside it, enabling the electrode wire to be placed in a precise position within the heart. At the same time, a tear groove is provided on the wall of the sheath body, ensuring that the tear groove does not interfere with the bending wire, facilitating the removal of the sheath body after the electrode wire is implanted into the heart. Attached Figure Description

[0023] The accompanying drawings, which are part of the specification of this application, illustrate embodiments of the present application and are used together with the description of the specification to illustrate the principles of the present application.

[0024] Figure 1 A schematic diagram of an electrode wire guide sheath according to an embodiment of this application is shown.

[0025] Figure 2 A cross-sectional schematic diagram of the sheath body of an electrode wire guiding sheath according to an embodiment of this application is shown.

[0026] Figure 3 A schematic diagram showing the location of the tear groove in the electrode wire guide sheath according to an embodiment of this application is shown.

[0027] Figure 4 A schematic diagram showing the location of another tear groove in the electrode wire guide sheath according to an embodiment of this application is shown.

[0028] Figure 5 A schematic diagram of an electrode wire guide sheath with a head end tube according to an embodiment of this application is shown.

[0029] Figure 6 A cross-sectional schematic diagram of an electrode lead guide sheath with a balloon and a radiopaque ring according to an embodiment of this application is shown.

[0030] Figure 7 A cross-sectional schematic diagram of the developing ring and the bending wire channel at the connection between the head end tube and the main body of the electrode wire guiding sheath according to an embodiment of this application is shown.

[0031] Figure 8 A schematic diagram showing the relative fixation method between the sheath body and the electrode wire of the electrode wire guiding sheath according to an embodiment of this application is shown.

[0032] Figure 9 A schematic diagram of another relative fixation method between the sheath body of the electrode wire guide sheath and the electrode wire according to an embodiment of this application is shown.

[0033] Figure 10 A schematic diagram of another relative fixation method between the sheath body of the electrode wire guide sheath and the electrode wire according to an embodiment of this application is shown.

[0034] Figure 11 A schematic diagram of another relative fixation method between the sheath body of the electrode wire guide sheath and the electrode wire according to an embodiment of this application is shown.

[0035] Figure 12 A schematic diagram of another relative fixation method between the sheath body of the electrode wire guide sheath and the electrode wire according to an embodiment of this application is shown.

[0036] Figure 13 A schematic diagram of another relative fixation method between the sheath body of the electrode wire guide sheath and the electrode wire according to an embodiment of this application is shown.

[0037] Figure 14 A schematic diagram of another relative fixation method between the sheath body of the electrode wire guide sheath and the electrode wire according to an embodiment of this application is shown.

[0038] Figure 15 A schematic diagram of a double-sheath electrode wire guide sheath according to an embodiment of this application is shown.

[0039] Figure 16 A schematic diagram of an inner sheath according to an embodiment of this application is shown.

[0040] Figure 17 A schematic diagram of the head end opening of the inner sheath of a double-sheath electrode wire guide sheath according to an embodiment of this application is shown.

[0041] Figure 18 A schematic diagram showing the relative fixation method between the sheath body and the electrode wire of a double-sheath electrode wire guide sheath according to an embodiment of this application is shown.

[0042] Figure 19 A schematic diagram of another relative fixation method between the sheath body and the electrode wire of a double-sheath electrode wire guide sheath according to an embodiment of this application is shown.

[0043] Figure 20 A schematic diagram of a rotating device for an electrode wire guide sheath according to an embodiment of this application is shown.

[0044] Figure 21 A schematic diagram of an electrode wire guide sheath equipped with an electrode rotation device according to an embodiment of this application is shown. Detailed Implementation

[0045] To make the objectives, technical solutions, and advantages of the embodiments of this application clearer, the spirit of the content disclosed in this application will be clearly explained below with reference to the accompanying drawings and detailed description. After understanding the embodiments of this application, any person skilled in the art can make changes and modifications based on the technology taught in this application without departing from the spirit and scope of this application.

[0046] The illustrative embodiments and descriptions provided in this application are for explaining the application, but are not intended to limit the application. Furthermore, elements / components using the same or similar reference numerals in the drawings and embodiments are used to represent the same or similar parts.

[0047] The terms “first,” “second,” etc., used in this document are not intended to specifically refer to order or sequence, nor are they used to limit this application; they are merely used to distinguish elements or operations described using the same technical terms.

[0048] The terms “include,” “including,” “have,” “contain,” etc., used in this article are all open-ended terms, meaning that they include but are not limited to.

[0049] The term "and / or" as used herein includes any or all of the things mentioned.

[0050] The term "multiple" in this article includes "two" and "more than two"; the term "multiple groups" in this article includes "two groups" and "more than two groups".

[0051] Certain terms used to describe this application will be discussed below or elsewhere in this specification to provide additional guidance to those skilled in the art in describing the application.

[0052] Electrode leads have a wide range of applications, including cardiac pacemakers. This application provides an electrode lead guide sheath through which electrode leads can be implanted into a patient's heart.

[0053] Specifically, the procedure involves first placing the main body of the guide sheath into the desired location in the heart via the patient's vein. Then, an electrode lead is inserted into the lumen of the sheath. Rotating the sheath causes the electrode lead to rotate, thus implanting it into the heart. Finally, the sheath is torn off and removed, completing the electrode lead implantation process. One end of the electrode lead can be connected to a pacemaker.

[0054] The electrode wire guiding sheath provided in this application includes: a handle with a bending adjustment component; and a sheath body, the proximal end of which is connected to the handle. The sheath body has a bending adjustment wire channel extending from the proximal end to the distal end within its wall. The bending adjustment wire is placed within this channel and connected to the bending adjustment component at the proximal end of the sheath body, allowing adjustment of the wire's bending direction. The sheath body also has a tear groove extending from the proximal end to the distal end, which does not coincide with the bending adjustment wire channel. In one embodiment, the closest distance between the tear groove and the bending adjustment wire channel is greater than 1 mm.

[0055] Figure 1 A schematic diagram of an electrode wire guiding sheath according to an embodiment of this application is shown. Figure 1 As shown, the electrode lead guide sheath includes a handle 1 and a sheath body 2. The proximal end of the sheath body 2 is connected to the handle 1.

[0056] Figure 2A schematic cross-sectional view of the sheath body is shown. (For example...) Figure 2 As shown, a bending wire channel 3 is provided inside the tube wall of the sheath body 2. This bending wire channel 3 extends from the proximal end to the distal end of the sheath body. The bending wire is placed within the bending wire channel 3. A bending adjustment component is provided on the handle 1, and the bending wire is connected to the bending adjustment component on the handle at the proximal end of the sheath body to adjust the bending of the bending wire.

[0057] In one embodiment, the handle 1 can rotate clockwise and counterclockwise. When the handle 1 rotates, it can drive the threaded column inside the handle 1 to move along the axis of the handle 1. The upper and lower ends of the column can be fixed with bending wires, so as to convert the rotational motion of the handle 1 into the axial motion of the column. When the handle rotates, the column moves along the axis, which can put the wire in the corresponding direction under force. The wire applies tension in the direction it is in, thereby pulling the distal end of the sheath body to bend.

[0058] Those skilled in the art will understand that, although Figure 2 The number of bending wire channels 3 shown is 2, but the number of bending wire channels 3 can also be 1, 3, 4, etc., depending on the actual situation.

[0059] Also refer to Figure 2 The sheath body 2 is also provided with a tear groove 4 extending from the proximal end to the distal end of the sheath body. The tear groove 4 does not coincide with the bending wire channel 3.

[0060] In one implementation, such as Figure 2 As shown, the tear opening of the tear groove 4 is located on the inner wall of the sheath body 2, facing towards the lumen of the sheath body 2. Of course, the tear opening of the tear groove 4 can also be located on the outer wall of the sheath body 2, facing towards the outer side of the sheath 2.

[0061] Those skilled in the art will understand that, although Figure 2 The number of tear grooves 4 shown is 2, but the number of tear grooves 4 can also be 1, 3, 4, etc.

[0062] In one embodiment, the sheath body has two or four bending wire channels inside its tube wall, and one or two tear grooves are provided on the tube wall of the sheath body.

[0063] Specifically, in one embodiment, two bending wire channels 3 are provided inside the tube wall of the sheath body 2. The two bending wire channels 3 are symmetrically arranged with respect to the central axis of the sheath body 2. The number of tear grooves 4 is greater than or equal to 2, and the tear grooves 4 are located on the same side of the two bending wire channels 3, thereby realizing that the bending function and tearing function of the guide sheath do not interfere with each other.

[0064] In one implementation, such as Figure 3 As shown, two bending wire channels 3 are provided inside the tube wall of the sheath body 2. The two bending wire channels 3 are symmetrically arranged with respect to the central axis of the sheath body 2. There are two tear grooves 4. The two tear grooves 4 are symmetrically arranged with respect to the two bending wire channels 3 and the included angle α between them and the line connecting them to the center of the cross-section of the sheath body 2 is 120 degrees.

[0065] In one implementation, such as Figure 4 As shown, two bending wire channels 3 are provided inside the tube wall of the sheath body 2. The two bending wire channels 3 are symmetrically arranged with respect to the central axis of the sheath body 2. There is one tearing groove 4. The distance between the tearing groove 4 and the two bending wires 3 is approximately equal.

[0066] In one embodiment, two bending wire channels 3 are provided inside the tube wall of the sheath body 2. The two bending wire channels 3 are symmetrically arranged with respect to the central axis of the sheath body 2. The number of tear grooves 4 is greater than or equal to 2. The tear grooves 4 are located on the same side of the two bending wire channels 3 and are evenly distributed between the two bending wires.

[0067] The arrangement of the bending wire channel 3 and the tearing groove 4 ensures that the bending and tearing functions of the guide sheath do not interfere with each other.

[0068] In one embodiment, when the number of tear grooves 4 is one, the tear grooves 4 can be torn using a tearing tool.

[0069] In one embodiment, the handle 1 is also provided with a tear groove, so that the handle 1 is also withdrawn when the guide sheath is withdrawn. Specifically, the tear groove on the handle 1 can be provided correspondingly to the tear groove on the sheath body 2.

[0070] In one implementation, such as Figure 5 As shown, the electrode lead guide sheath also includes a tip tube 5, which is connected to the sheath body 2 at its distal end. The tip tube 5 is made of a softer material than the sheath body 2. In one embodiment, the tip tube 5 and the sheath body 2 can be connected by welding. In one embodiment, the tip tube 5 is made of the same material as the sheath body 2 but is softer, for example, the sheath body 2 is made of 72D PEBAX material and the tip tube 5 is made of 55D PEBAX material. Alternatively, the tip tube 5 is made of a different material than the sheath body 2 and is softer, for example, the sheath body 2 is made of 72D PEBAX material and the tip tube 5 is made of 40D TPU material. This allows for a soft tip tube, reducing irritation when the sheath enters the blood vessel, thereby reducing the risk of cardiac tamponade.

[0071] In one embodiment, the head tube 5 is also provided with a tear groove extending from the proximal end of the head tube 5 to the distal end of the head tube 5, so as to facilitate the removal of the head tube 5 at the same time when the guide sheath is removed.

[0072] In one embodiment, the bending wire channel 3 and the bending wire do not extend to the head end tube 5.

[0073] In one implementation, such as Figure 6 As shown, a balloon 6 is disposed on the outer wall of the tip tube 5. The balloon 6 can be fused to the outer wall of the tip tube 5. The material of the balloon can be the same as or different from that of the tip tube 5, but it is more flexible than the tip tube 5. Because the balloon 6 itself is more flexible and the balloon is fixed to the outer wall surface of the catheter, this structure can further realize the flexibility of the tip compared to the tube body itself being in contact with the blood vessel. The balloon 6 can completely wrap around the outer wall of the tip tube 5, or multiple small balloons can be distributed around the circumference of the outer wall of the tip tube 5.

[0074] Furthermore, in one embodiment, the balloon 6 may be hollow. The interior of the balloon 6 may be filled with an ultrasound contrast agent. In another embodiment, the balloon 6 may be made of an ultrasound-contrast material, for example, the balloon may be a microbubble contrast agent encapsulated with materials such as denatured albumin, liposomes, polymers, or various surfactants. Thus, during the implantation of the electrode leads, the position of the balloon can be observed in real time through intracardiac ultrasound imaging, thereby effectively reducing the risk of X-ray exposure for patients and physicians during existing implantation procedures. Simultaneously, the determination of the lead implantation position under intracardiac ultrasound imaging is more accurate, thereby improving implantation precision and efficiency. Those skilled in the art will understand that the mention of "made of ultrasound-contrast material" herein refers to including ultrasound-contrast materials, but may also include other materials.

[0075] In one implementation, such as Figure 6 As shown, a radiopaque ring 7 made of ultrasonic radiopaque material is provided on the inner wall of the head tube 5 or the inner wall of the sheath body 2. The radiopaque ring 7 is located on the side of the head tube 5 adjacent to the sheath body 2 or on the side of the sheath body 2 adjacent to the head tube 5. Figure 7 A cross-sectional schematic diagram of the imaging ring 7 and the bending wire channel 3 at the connection between the head tube 5 and the sheath body 2 according to an embodiment of this application is shown.

[0076] In one embodiment, the imaging ring 7 can be a ring composed of two or more arc-shaped segments. The arc joint of the imaging ring 7 can be aligned with the tear groove of the tip tube 5 or the sheath body 2 to facilitate sheath tearing after electrode wire implantation.

[0077] In one embodiment, the imaging ring 7 can be made of a high-density imaging material such as zirconium oxide or a platinum-iridium alloy to enable intracardiac ultrasound imaging, thereby effectively reducing the risk of exposure to X-rays for patients and physicians during existing implantation procedures. Simultaneously, intracardiac ultrasound imaging allows for more accurate determination of the lead implantation location, thus improving implantation precision and efficiency. Furthermore, the surface of the imaging ring 7 is frosted to better facilitate ultrasound imaging, thereby enabling precise positioning of the guide sheath.

[0078] Furthermore, after the electrode lead is positioned to the desired location, it needs to be rotated to implant it into the heart. This is typically achieved by rotating the guide sheath. However, because the electrode lead itself is relatively soft, it cannot effectively transmit torque; sometimes, even after multiple rotations at the proximal end, the distal end of the electrode lead remains stationary. Therefore, in one embodiment of this application, the electrode lead guide sheath further includes a clamping device disposed on the sheath body 2. When pressurized, this clamping device extends into the lumen of the sheath body 2. Thus, as the clamping device extends into the lumen of the sheath body 2, it can compress the electrode lead within the lumen, i.e., the clamping device and / or the inner wall of the sheath body hold the electrode lead within the lumen, achieving relative fixation between the electrode lead and the sheath body. This allows the electrode lead to rotate synchronously with the sheath body, making the implantation process more controllable.

[0079] In one embodiment, a clamping device is disposed at the distal end of the sheath body 2 so as to fix the sheath body 2 and the electrode lead relative to each other at the distal end of the sheath body 2, so as to better realize the rotational linkage between the sheath body 2 and the distal end of the electrode lead, thereby better performing intracardiac implantation of the electrode lead.

[0080] In one embodiment, the clamping device may be a cavity, a balloon, a spring, or a polymer material.

[0081] Specifically, in one implementation, such as Figure 8 As shown, the clamping device is a cavity 8 located within the wall of the sheath body 2. When gas or liquid is injected into the cavity 8, the cavity 8 expands in volume and extends towards the interior of the tube, simultaneously causing the inner wall of the sheath body 2 to expand towards the interior of the tube. This compresses the electrode wire 9 within the tube, fixing the electrode wire 9 relative to the sheath body 2, thus enabling the electrode wire 9 and the sheath body 2 to rotate synchronously during wire implantation. Specifically, a channel 10 connecting the cavity 8 can be provided within the tube wall, connecting to the inflation / liquid port near the proximal end of the guide sheath, allowing gas or liquid to be injected into the cavity 8 from the inflation / liquid port near the proximal end of the guide sheath. Figure 8Only the cavity 8 on one side of the electrode wire 9 is shown. Those skilled in the art will understand that cavities 8 can also be present on both sides, or the cavity 8 can surround the circumferential direction of the tube wall cross-section of the sheath body 2, thereby enclosing the electrode wire 9. In one embodiment, as... Figure 8 As shown, the inner wall of the sheath body 2 corresponding to the cavity 8 can also be made into an uneven shape so as to better fix it relative to the electrode wire 9.

[0082] In one implementation, such as Figure 9 As shown, the clamping device is a balloon 11 disposed on the inner wall of the sheath body 2. When gas or liquid is injected into the balloon 11, the volume of the balloon 11 increases, and the balloon expands towards the lumen, thereby squeezing the electrode wire 9 inside the lumen, fixing the electrode wire 9 relative to the sheath body 2, thus enabling the electrode wire 9 and the sheath body 2 to rotate synchronously during wire implantation. Specifically, a channel 12 connecting the balloon 11 can be provided in the tube wall, and the channel 12 connects to the inflation / fluid filling port at the proximal end of the guide sheath, so that gas or liquid can be injected into the balloon 11 from the inflation / fluid filling port at the proximal end of the guide sheath. The balloon 11 can surround the circumference of the tube wall cross section of the sheath body 2, thereby wrapping the electrode wire 9, or one or more small balloons 9 can be provided in the circumference of the tube wall cross section of the sheath body 2. Similarly, the surface of the balloon 9 can be made into an uneven shape to better fix it relative to the electrode wire 9.

[0083] In one implementation, such as Figure 10 and Figure 11 As shown, the clamping device is a spring 13 installed on the inner wall of the sheath body 2. The spring 13 expands in a direction perpendicular to the compression direction when compressed. The proximal end of the spring 13 is fixed to the wall of the sheath body 2, and the distal end is close to the control ring 15. A pressure wire 14 is also connected to the control ring 15. The other end of the pressure wire 14 extends through the wall of the sheath body 2 to the proximal end of the sheath body 2. When the pressure wire 14 is pulled at the proximal end of the sheath body 2, the pressure wire 14 moves towards the proximal end of the sheath body 2, causing the control ring 15 to move towards the proximal end. The control ring 15 pushes the distal end of the spring 13 towards the proximal end. Since the proximal end of the spring 13 is already fixed to the tube wall of the sheath body 2, the spring 13 is compressed. The spring 13 expands in a direction perpendicular to the compression direction, that is, it expands towards the inside of the tube, thereby squeezing the electrode wire 9 inside the tube and fixing the electrode wire 9 relative to the sheath body 2. This allows the electrode wire 9 to rotate synchronously with the sheath body 2 during wire implantation. The spring 13 can be a single spring or multiple springs evenly distributed along the circumference of the tube wall cross-section of the sheath body 2. Figure 10 and Figure 11Two springs 13 are shown in the axisymmetric direction of the sheath body 2. In one embodiment, the pressure wire 14 may be a bending wire, i.e., the pressure wire and the bending wire are shared, or the pressure wire 14 may be a separate wire. The control ring 15 may be a developing ring, i.e., the control ring and the developing ring are shared, or the control ring 15 may be a separate ring.

[0084] In one implementation, such as Figure 12 As shown, the clamping device is a polymer material 16 disposed on the inner wall of the sheath body 2. The polymer material 16 can be, for example, rubber, latex, silicone, or other polymer materials. The proximal end of the polymer material 16 is fixed to the tube wall of the sheath body 2, and the distal end is close to the control ring 18. A pressure wire 17 is also connected to the control ring 18. The other end of the pressure wire 17 extends through the tube wall of the sheath body 2 to the proximal end of the sheath body 2. When the pressure wire 17 is pulled at the proximal end of the sheath body 2, the pressure wire 17 moves towards the proximal end of the sheath body 2, causing the control ring 18 to move towards the proximal end. The control ring 18 pushes the distal end of the polymer material 16 towards the proximal end. Since the proximal end of the polymer material 16 is already fixed to the wall of the sheath body 2, the polymer material 16 is compressed. The polymer material 16 expands in a direction perpendicular to the compression direction, that is, it expands towards the lumen, thereby squeezing the electrode wire 9 inside the lumen and fixing the electrode wire 9 relative to the sheath body 2. This allows the electrode wire 9 to rotate synchronously with the sheath body 2 during wire implantation. In one embodiment, the pressure wire 17 can be a bending wire, that is, the pressure wire and the bending wire are shared, or the pressure wire 17 can be a separate wire. The control ring 18 can be a imaging ring, that is, the control ring and the imaging ring are shared, or the control ring 18 can be a separate ring.

[0085] In the above embodiments, the wall of the sheath body 2 at the balloon 11, spring 13 or polymer material 16 can be made thin, so that the balloon 11, spring 13 or polymer material 16 can be partially or completely sunk into the recess of the tube wall in the relaxed state.

[0086] In one implementation, such as Figure 13As shown, the clamping device consists of a spring 19 and a polymer material 20 disposed within the wall of the sheath body 2. The polymer material 20 can be, for example, rubber, latex, silicone, or other polymeric materials. The proximal end of the spring 19 is fixed to the wall of the sheath body 2. The distal end of the spring 19 and the proximal end of the polymer material 20 are located on opposite sides of the control ring 22. A pressure wire 21 is also connected to the control ring 22. The other end of the pressure wire 21 extends through the wall of the sheath body 2 to the proximal end of the sheath body 2. An opening 23 is provided on the inner wall of the sheath body 2 corresponding to the distal end of the polymer material 20. When the pressure wire 21 is released at the proximal end of the sheath body 2, the spring 19 is released elastically, and the distal end of the spring 19 moves toward the distal end of the sheath body, pushing the control ring 22 to move distally. The control ring 22 pushes the proximal end of the polymer material 16 to move distally. Under the action of the thrust, the distal end of the polymer material 16 extends out from the opening 23 on the inner wall of the sheath body 2, thereby squeezing the electrode wire 9 in the lumen and fixing the electrode wire 9 relative to the sheath body 2, so that the electrode wire 9 and the sheath body 2 can rotate synchronously during wire implantation. In one embodiment, the pressure wire 21 can be a bending wire, that is, the pressure wire and the bending wire are shared, or the pressure wire 21 can also be a separate wire. The control ring 22 can be a imaging ring, that is, the control ring and the imaging ring are shared, or the control ring 22 can also be a separate ring.

[0087] In one implementation, such as Figure 14 As shown, the clamping device is the wall of the sheath body 2 itself. The distal end of the pressure wire 24 is connected to the control ring 25. The other end of the pressure wire 21 extends through the wall of the sheath body 2 to the proximal end of the sheath body 2. When the pressure wire 24 is pulled at the proximal end of the sheath body 2, the pressure wire 24 moves towards the proximal end of the sheath body 2, causing the control ring 25 to move towards the proximal end. Since the control ring 25 is fixed to the sheath body 2, the sheath body 2 itself is compressed, causing the wall of the sheath body 2 to expand in a direction perpendicular to the compression direction, thereby squeezing the electrode wire 9 in the lumen, so that the electrode wire 9 is relatively fixed to the sheath body 2, thereby enabling the electrode wire 9 and the sheath body 2 to rotate synchronously during wire implantation. In one embodiment, the pressure wire 24 can be a bending wire, that is, the pressure wire and the bending wire are shared, or the pressure wire 24 can be a separate wire. The control ring 25 can be a developing ring, that is, the control ring is shared with the developing ring, or the control ring 25 can be a separate ring.

[0088] Through the above embodiments, the relative fixation between the sheath body 2 and the electrode lead 9 can be achieved, so that the electrode lead can rotate synchronously with the sheath body, thereby making the lead implantation process more controllable. After the lead implantation is completed, the clamping device can be released through the channel or the pressure wire, thereby removing the guide sheath after releasing the electrode lead 9.

[0089] The single-sheath type of electrode lead guide sheath has been described above. Furthermore, embodiments of this application also provide a double-sheath type of electrode lead guide sheath. That is, the electrode lead guide sheath further includes an inner sheath. The inner sheath includes an inner sheath tube body and an inner sheath handle connected to the proximal end of the inner sheath tube body. The inner sheath handle is disposed at the proximal end of the handle, and the inner sheath tube body is disposed within the lumen of the sheath tube body and extends out of the sheath tube body from its distal end. A tear groove is provided on the wall of the inner sheath tube body, extending from the proximal end to the distal end of the inner sheath tube body.

[0090] Figure 15 A schematic diagram of a double-sheath electrode wire guide sheath according to an embodiment of this application is shown. Figure 16 A schematic diagram of an inner sheath according to an embodiment of this application is shown. Figure 15 and 16 As shown, the electrode lead guide sheath includes a handle 1, a sheath body 2, and an inner sheath. The inner sheath includes an inner sheath handle 26 and an inner sheath body 27. The inner sheath handle 26 is connected to the proximal end of the inner sheath body 27. The inner sheath handle 26 is disposed at the proximal end of the handle 1, and the inner sheath body 27 is disposed within the handle 1 and the sheath body 2 and extends from the distal end of the sheath body 2. The inner sheath body 27 has a tear groove extending from the proximal end to the distal end of the inner sheath body, thereby tearing and withdrawing the inner sheath body 27 after the electrode lead is implanted into the heart. In one embodiment, the inner sheath handle 26 is also provided with a tear groove, so that the inner sheath handle 26 is withdrawn simultaneously when the guide sheath is withdrawn.

[0091] In the case of a double-sheathed guiding sheath, the electrode wire is inserted into the lumen of the inner sheath body 27, but the problem of the electrode wire not rotating synchronously with the inner sheath body 27 and the sheath body 2 still exists. Therefore, in one embodiment of this application, the relative movement between the inner sheath body 27 and the sheath body 2 can be used to extend the wall of the inner sheath body 27 toward the lumen, thereby achieving relative fixation between the electrode wire and the inner sheath body 27.

[0092] Specifically, in one implementation, such as Figure 17 As shown, at the head end of the inner sheath body 27, the inner wall diameter gradually decreases from the proximal end to the distal end, and reaches its minimum at the distal opening 271 of the inner sheath body 27. Figure 18A frontal schematic diagram of the head opening 271 of the inner sheath body 27 is shown. (See attached diagram.) Figure 18 As shown, multiple slots 272 are provided on the head opening 271, extending along the direction of the inner sheath body 27. Thus, when the electrode wire is inserted into the inner sheath body 27 and extends out of the head opening 271, the head wall of the inner sheath body 27 is stretched open. At this time, when the sheath body 2 moves towards the head of the inner sheath body 27, the inner wall of the sheath body 2 presses against the outer wall of the inner sheath body 27 at the head, causing the wall of the inner sheath body 27 to press towards the cavity of the inner sheath body, thereby compressing the electrode wire within the cavity and fixing the electrode wire relative to the inner sheath body 27. This allows the electrode wire and the inner sheath body 27 to rotate synchronously during wire implantation.

[0093] In one implementation, such as Figure 17 As shown, at the head end of the inner sheath body 27, the inner wall diameter gradually decreases from the proximal end to the distal end, reaching its minimum at the distal opening 271 of the inner sheath body 27. Figure 19 As shown, at the head end of the inner sheath body 27, an expansion ring or thread 272 is provided on the outer wall of the inner sheath body 27. A protrusion 21 can be provided at a corresponding position on the inner wall of the sheath body 2 to cooperate with the expansion ring or thread 272. When the sheath body 2 moves toward the head end of the inner sheath body 27, the protrusion 21 at the head end of the inner sheath body 27 engages with the distal end of the expansion ring or thread 272, thereby causing the inner sheath body 27 to compress the electrode wire in the cavity, so that the electrode wire and the inner sheath body 27 are relatively fixed, thereby enabling the electrode wire and the inner sheath body 27 to rotate synchronously during wire implantation.

[0094] Furthermore, in the prior art, because the electrode leads need to be rotated during implantation, the electrode leads cannot be connected to a multi-channel analyzer for real-time monitoring of the implantation process. Therefore, the electrode lead guide sheath provided in this application embodiment may further include an electrode rotation device. This electrode rotation device allows for simultaneous connection to a multi-channel analyzer during electrode lead implantation, enabling real-time monitoring of the implantation process.

[0095] The electrode rotation device of this application embodiment includes: a fixed rotation device connected to the handle, used to fix the handle and the sheath body, and to drive the handle, the sheath body and the electrode wire inside the sheath body to rotate by rotating the fixed rotation device; and an electrode clamp pair, including two parallel electrode clamps, which are fixedly arranged and used to clamp the electrode of the electrode wire, wherein each electrode clamp of the electrode clamp pair is used to be connected to a multiconductor via a wire.

[0096] In one embodiment, the aforementioned fixed-rotation device may include a fixing device and a rotating device, wherein the fixing device is used to fix the handle, the sheath body and the electrode wire, and the rotating device is used to rotate.

[0097] Figure 20 A schematic diagram of an electrode rotating device according to an embodiment of this application is shown. Figure 21 A schematic diagram of an electrode wire guide sheath equipped with an electrode rotation device according to an embodiment of this application is shown. Figure 20 and 21 As shown, the electrode rotating device includes a fixing device 28, a rotating device 29, and electrode clips 30. The fixing device 28 is used to fix the handle 1, the sheath body 2, and the electrode wires. Specifically, the sheath body 2 and the electrode wires pass through the fixing device 28, and the fixing device 28 can separately fix the inserted sheath body 2 and electrode wires in stages. The rotating device 29 can be manually rotated, simultaneously rotating the sheath body 2 and the electrode wires. Specifically, the fixing device 28 can move axially and contains a spring. When not moving, the spring is in a relaxed state. When in use, the fixing device 28 is moved axially, compressing the spring. At this time, the handle 1 can be inserted into the fixing device 28, and the fixing device 28 can be released. The spring relaxes, fixing the sheath handle 1 and the fixing device 28 into a whole. The rotating device 29 and the fixing device 28 should not have relative movement. When the rotating device 29 rotates, it can drive the fixing device 28 to rotate synchronously. The electrode clip pair 30 includes two parallel electrode clips 301 and 302, the distance between which is approximately equal to the diameter of the electrode on the electrode wire, to clamp the electrode on the electrode wire. The electrode clips can be connected to a multiconductor via a wire 31 and a multiconductor connector 32. In one embodiment, when the electrode wire has two electrodes, positive and negative, two electrode clip pairs 30 can be provided to clamp the positive and negative electrodes of the electrode wire respectively. Furthermore, the electrode rotating device may include a handle, and the electrode clip pair 30 and the wire 31 are housed within the handle. Thus, when the electrode wire is implanted, the rotating device 29 rotates the electrode wire, and the electrode on the electrode wire rotates between the fixed electrode clips 301 and 302. The electrode clips 301 and 302 are always in contact with the electrode on the electrode wire, avoiding the situation in the prior art where the electrode wire cannot be connected to the multiconductor due to being twisted multiple times during implantation.

[0098] The above description is merely an illustrative embodiment of this application. Any equivalent changes and modifications made by those skilled in the art without departing from the concept and principles of this application shall fall within the scope of protection of this application.

Claims

1. An electrode wire guiding sheath, characterized in that, include: A handle, on which a bending adjustment component is provided; as well as The sheath body, the proximal end of which is connected to the handle. The sheath body has an adjusting wire channel extending from its proximal end to its distal end within its tube wall. The adjusting wire is placed within this channel and is connected to an adjusting component of the handle at its proximal end, allowing the bending of the adjusting wire to be adjusted via the adjusting component. The sheath body also has a tear groove extending from the proximal end to the distal end of the sheath body on its tube wall.

2. The electrode wire guiding sheath according to claim 1, characterized in that, The sheath body has two or four bending wire channels inside its tube wall, and one or two tear grooves on its tube wall.

3. The electrode wire guiding sheath according to claim 1 or 2, characterized in that, Also includes: A head tube is connected to the sheath body at the distal end of the sheath body, and the material of the head tube is softer than the material of the sheath body.

4. The electrode wire guiding sheath according to claim 3, characterized in that, A balloon is provided on the outer wall of the head end tube. The balloon is hollow or made of an ultrasound-detectable material.

5. The electrode wire guiding sheath according to claim 3, characterized in that, The inner wall of the head tube or sheath body is provided with a imaging ring made of ultrasonic imaging material.

6. The electrode wire guiding sheath according to claim 1 or 2, characterized in that, Also includes: A clamping device is provided on the sheath body, which expands toward the lumen of the sheath body when pressurized.

7. The electrode wire guiding sheath according to claim 6, characterized in that, The clamping device is a cavity, a balloon, a spring, or a polymer material.

8. The electrode wire guiding sheath according to claim 1, characterized in that, Also includes: An inner sheath includes an inner sheath tube body and an inner sheath handle connected to the proximal end of the inner sheath tube body. The inner sheath handle is disposed at the proximal end of the handle. The inner sheath tube body is disposed within the lumen of the sheath tube body and extends out of the sheath tube body from its distal end. The inner sheath body has a tear groove on its wall extending from the proximal end to the distal end of the inner sheath body.

9. The electrode wire guiding sheath according to claim 8, characterized in that, The inner wall diameter at the head end of the inner sheath tube body gradually decreases from the proximal end to the distal end, and the head end opening of the inner sheath tube is provided with multiple slots extending along the direction of the inner sheath tube body.

10. The electrode wire guiding sheath according to any one of claims 1-9, characterized in that, Also includes: Electrode rotation device The electrode rotating device includes: A fixed rotating device, connected to the handle, is used to fix the handle and the sheath body, and the rotation of the fixed rotating device drives the handle, the sheath body, and the electrode wires inside the sheath body to rotate; and An electrode clip pair includes two parallel electrode clips, which are fixedly arranged and used to clamp the electrode of the electrode wire. Each electrode clip of the electrode clip pair is used to connect to a multiconductor via a wire.

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