Cardiac pacemaker electrode lead delivery sheath

Abstract

The present disclosure provides a cardiac pacemaker electrode lead delivery sheath, comprising a sheath base and a sheath tube, the sheath base is provided with a sheath tube interface; the sheath tube comprises a connecting area, a buffer area and an implantation area arranged in sequence along the axial direction, the connecting area is fixedly connected with the sheath tube interface, the buffer area connects the connecting area and the implantation area, the inner wall of the buffer area is provided with a protruding structure, and the cutting resistance of the cutting tool in the buffer area is between the cutting resistances of the sheath base and the implantation area. The present disclosure makes the sheath base and the implantation area of the sheath tube transition through the buffer area, because the buffer area is provided with the protruding structure, the friction and resistance are increased, the cutting resistance of the cutting tool in the buffer area decreases from one side close to the connecting area to one side close to the implantation area, therefore the cutting force required for cutting the buffer area gradually decreases from the connecting area to the implantation area, the force is easier to grasp and the cutting is smoother in the whole cutting process, and the operation difficulty of the user is reduced.

Description

Technical Field

[0001] This invention relates to the field of medical device technology, and in particular to a cardiac pacemaker electrode lead delivery sheath. Background Technology

[0002] A pacemaker is an implantable electronic therapeutic device that delivers electrical pulses powered by a battery through a pulse generator. These pulses are conducted through electrodes to stimulate the myocardium touched by the electrodes, causing the heart to beat and contract, thereby treating cardiac dysfunction caused by certain arrhythmias. The most crucial step in pacemaker implantation surgery is the implantation of the pacemaker electrodes.

[0003] In clinical surgery, the implantation of pacemaker electrodes requires the assistance of an auxiliary sheath for guidance and support. The specific procedure involves first inserting the sheath into the heart chamber, and then advancing the electrode through the sheath into the heart chamber. After the electrode is secured, the sheath needs to be withdrawn from the body. However, because there are other testing devices connected to the other end of the electrode, the withdrawal of the sheath causes interference. Therefore, the sheath needs to be cut axially to complete the entire sheath removal operation.

[0004] Currently, the sheaths on the market are thicker at the junction of the sheath seat and the sheath tube (hereinafter referred to as the junction) and thinner at the sheath tube. This results in a greater force required to cut the junction but less force required to cut the sheath tube. The force difference between the junction and the sheath tube is significant. Due to inertia, doctors need to control the force during cutting, which places high demands on their skills and makes force control difficult. There is also a risk of causing unnecessary harm to the patient. Summary of the Invention

[0005] To address the shortcomings of existing technologies, the present invention aims to provide a cardiac pacemaker electrode lead delivery sheath that reduces the difficulty of operation for users and lowers the risks associated with clinical use of the delivery sheath.

[0006] A first aspect of this disclosure provides a cardiac pacemaker electrode lead delivery sheath, comprising:

[0007] Sheath base, equipped with sheath tube interface;

[0008] The sheath includes a connecting area, a buffer zone, and an implantation zone arranged sequentially along the axial direction. The connecting area is fixedly connected to the sheath interface. The buffer zone connects the connecting area and the implantation zone. The inner wall of the buffer zone is provided with a protruding structure. The protruding structure makes the cutting resistance of the cutting tool in the buffer zone between the cutting resistance of the sheath seat and the implantation zone.

[0009] Optionally, the protrusion structure includes a first protrusion extending along the inner circumference of the inner wall, thereby being cut when the cutting tool cuts the buffer zone; and

[0010] The number of the first protrusions is one, and the thickness of the first protrusion decreases from the side closer to the connection area to the side closer to the implantation area; or, the number of the first protrusions is multiple, and the multiple first protrusions are distributed at intervals along the axial direction of the sheath, and the thickness and / or length of the first protrusions closer to the connection area is greater than the thickness and / or length of the first protrusions closer to the implantation area.

[0011] Optionally, the first protrusion has a groove for guiding the cutting direction of the cutting tool; the groove is opened along the axial direction of the sheath and is recessed from the surface of the first protrusion toward the inner wall of the sheath.

[0012] Optionally, the protrusion structure includes a second protrusion, the second protrusion including a first protrusion portion and a second protrusion portion, a gap between the first protrusion portion and the second protrusion portion, the width of the gap being configured to clamp the cutting tool thereby providing frictional resistance when the cutting tool cuts the buffer zone.

[0013] Optionally, the width of the gap increases from the side closer to the connection area to the side closer to the implantation area; and / or

[0014] The portion of the gap near the connection area forms a flared opening.

[0015] Optionally, the second protrusion may include multiple sets arranged around the inner wall.

[0016] A second aspect of this disclosure provides a cardiac pacemaker electrode lead delivery sheath, comprising:

[0017] Sheath base, equipped with sheath tube interface;

[0018] The sheath includes a connecting area, a buffer zone, and an implantation zone arranged sequentially along the axial direction. The connecting area is fixedly connected to the sheath interface. The buffer zone connects the connecting area and the implantation zone. The inner wall of the buffer zone is provided with a protruding structure, which includes a first protrusion and a second protrusion. The first protrusion extends along the inner circumference of the inner wall so that it can be cut when a cutting tool cuts the buffer zone. The second protrusion includes a first protruding portion and a second protruding portion. There is a gap between the first protruding portion and the second protruding portion. The width of the gap is configured to clamp the cutting tool so as to provide frictional resistance when the cutting tool cuts the buffer zone. The first protrusion has a groove for guiding the cutting direction of the cutting tool. The groove corresponds to the gap. The protruding structure makes the resistance of the cutting tool in the buffer zone between the resistance of the sheath seat and the implantation zone.

[0019] Optionally, the sheath is formed by processing multiple segments of polymer material with different hardness in the axial direction, and the hardness of the sheath decreases from the proximal end near the sheath seat to the distal end away from the sheath seat.

[0020] Optionally, the sheath seat includes a sheath seat body, a side support, and a handle. The sheath seat body has a sheath cap interface, a sheath tube interface, and a channel connecting the sheath tube interface and the sheath cap interface. The handle is connected to the sheath seat body, and the side support passes through the handle and connects to the channel. The wall thickness of the sheath tube body on the side near the sheath tube interface is less than the wall thickness on the side near the sheath cap interface.

[0021] Optionally, it also includes a hemostatic valve, wherein the inlet of the hemostatic valve is located at the sheath cap interface, and the outlet of the hemostatic valve passes through the sheath cap interface and enters the channel;

[0022] The hemostatic valve is provided with an elastic structure for shielding the outlet. The elastic structure can be opened by top pressure to expose the outlet, and automatically closes to seal the outlet after the top pressure is released. The outer periphery of the hemostatic valve is provided with reinforcing ribs near the elastic structure.

[0023] Optionally, the hemostatic valve is fixed to the sheath cap interface by a sheath cap. The sheath cap includes a sheath cap body, a bayonet, and an instrument channel. The sheath cap body includes a sheath cap top and an annular sidewall connecting the sheath cap top. The bayonet is formed on the annular sidewall, and the instrument channel extends from the sheath cap top to the annular sidewall.

[0024] The outer wall of the sheath seat body is provided with a locking block, and the outer edge of the inlet of the hemostatic valve abuts between the sheath cap interface and the top of the sheath cap, and the locking block is inserted into the locking slot of the sheath cap.

[0025] A third aspect of this disclosure also provides a method for preparing a cardiac pacemaker electrode lead delivery sheath, comprising: when manufacturing the sheath using an extruder, performing segmented temperature control on the head end of the extruder, wherein the segmented temperature control refers to the extrusion temperature of the portion with a thicker wall on the upper part of the sheath being greater than the extrusion temperature of the portion with a thinner wall on the upper part of the sheath being made.

[0026] Optionally, the temperature difference between the extrusion temperature of the thicker portion of the sheath and the extrusion temperature of the thinner portion of the sheath is determined based on the thickness difference between the thicker portion of the sheath and the thinner portion of the sheath. For every 1 mm increase in the thickness difference, the temperature difference increases by 8℃-10℃.

[0027] Optionally, multiple perforated venting structures may be added to the die at the extruder head end.

[0028] Implementing the above plan will have the following beneficial effects:

[0029] By incorporating a connecting area, a buffer zone, and an implantation zone on the sheath, the sheath is fixedly connected to the sheath seat via the connecting area. A buffer zone provides a transition between the sheath seat and the implantation zone. The buffer zone features a raised structure, increasing resistance and causing the cutting resistance of the cutting tool to decrease from the side closer to the connecting area to the side closer to the implantation zone. Therefore, the cutting force required to cut the buffer zone gradually decreases from the connecting area to the implantation zone, making the cutting process easier to control and smoother, reducing the difficulty of operation for the user, lowering surgical risks, and avoiding unnecessary harm to the patient. Furthermore, during the sheath molding process using rheological technology, temperature control combined with increased venting ensures uniform rheological distribution within the sheath buffer zone. Attached Figure Description

[0030] This specification will further illustrate embodiments by way of exemplary models, which will be described in detail with reference to the accompanying drawings. These embodiments are not limiting; in these embodiments, the same reference numerals denote the same structures, wherein:

[0031] Figure 1 This is a schematic diagram of the structure of a cardiac pacemaker electrode lead delivery sheath provided in an embodiment of this disclosure;

[0032] Figure 2 This is a schematic diagram of the structure of the connection between the sheath seat and the sheath tube provided in an embodiment of this disclosure;

[0033] Figure 3 This is a schematic diagram of the structure of the sheath seat provided in an embodiment of this disclosure;

[0034] Figure 4 This is a schematic diagram of the structure of the sheath body and the handle provided in this embodiment of the disclosure;

[0035] Figure 5 This is a schematic diagram of the hemostatic valve provided in an embodiment of this disclosure;

[0036] Figure 6 This is a schematic diagram of the outlet opening of the hemostatic valve provided in an embodiment of this disclosure;

[0037] Figure 7 This is a schematic diagram of the outlet closure of the hemostatic valve provided in an embodiment of this disclosure;

[0038] Figure 8 This is a schematic diagram of the sheath cap provided in an embodiment of this disclosure;

[0039] Figure 9 This is a schematic diagram of the assembled structure of the sheath cap, hemostatic valve, and sheath seat provided in the embodiments of this disclosure.

[0040] In the diagram: 100 Sheath seat, 101 Sheath tube interface, 102 Sheath seat body, 103 Side support, 104 Handle, 105 Locking block, 106 Luer connector, 107 Cutout, 108 Channel, 109 Sheath cap interface.

[0041] 200 Sheath, 201 Connecting area, 202 Buffer zone, 203 Implantation area, 204 First protrusion, 205 Second protrusion, 206 Groove, 207 Gap, 208 First protrusion, 209 Second protrusion

[0042] 300 Hemostatic valve, 301 Inlet, 302 Outlet, 303 Elastic structure, 304 Reinforcing rib.

[0043] 400 Sheath cap, 401 Sheath cap body, 402 Bayonet, 403 Instrument channel. Detailed Implementation

[0044] To make the objectives, technical solutions, and advantages of the embodiments of the present invention clearer, the technical solutions of the embodiments of the present invention will be clearly and completely described below with reference to the accompanying drawings. Obviously, the described embodiments are only some embodiments of the present invention, and not all embodiments. The components of the embodiments of the present invention described and shown in the accompanying drawings can generally be arranged and designed in various different configurations.

[0045] Therefore, the following detailed description of the embodiments of the invention provided in the accompanying drawings is not intended to limit the scope of the claimed invention, but merely to illustrate selected embodiments of the invention. All other embodiments obtained by those skilled in the art based on the embodiments of the invention without inventive effort are within the scope of protection of the invention.

[0046] It should be noted that similar labels and letters in the following figures indicate similar items. Therefore, once an item is defined in one figure, it does not need to be further defined and explained in subsequent figures.

[0047] In the description of this invention, it should be noted that the terms "upper," "lower," "left," "right," "vertical," "horizontal," "inner," and "outer," etc., indicate the orientation or positional relationship based on the orientation or positional relationship shown in the accompanying drawings, or the orientation or positional relationship commonly used when the product of this invention is in use. They are used only for the convenience of describing the invention and for 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 the invention. Furthermore, the terms "first," "second," and "third," etc., are used only to distinguish descriptions and should not be construed as indicating or implying relative importance. In the description of this invention, unless otherwise stated, "a plurality of" means two or more.

[0048] In the description of this invention, it should also be noted that, unless otherwise explicitly specified and limited, the terms "set" and "connection" should be interpreted broadly. For example, they can refer to a fixed connection, a detachable connection, or an integral connection; they can refer to a mechanical connection or an electrical connection. Those skilled in the art can understand the specific meaning of the above terms in this invention based on the specific circumstances.

[0049] Embodiments of the present invention are described in detail below. Examples of these embodiments are shown in the accompanying drawings, wherein the same or similar reference numerals denote the same or similar elements or elements having the same or similar functions throughout. The embodiments described below with reference to the accompanying drawings are exemplary and are only used to explain the present invention, and should not be construed as limiting the present invention.

[0050] This disclosure provides a cardiac pacemaker electrode lead delivery sheath, which includes at least a sheath seat 100 and a sheath tube 200. The sheath seat 100 is provided with a sheath tube interface 101. The sheath tube 200 includes a connection area 201, a buffer zone 202, and an implantation area 203 arranged sequentially along the axial direction. The sheath tube 200 of the connection area 201 is inserted into the sheath tube interface 101 and fixedly connected to the sheath tube interface 101. The inner wall of the buffer zone is provided with a protruding structure. The protruding structure makes the cutting resistance of the cutting tool in the buffer zone 202 between the cutting resistance of the sheath seat 100 and the cutting resistance of the implantation area 203.

[0051] The sheath 200 has a thicker wall at the connection point with the sheath seat 100, requiring a larger cutting force. Conversely, the sheath 200 has a thinner wall, requiring a smaller cutting force. When cutting the sheath seat 100 and the sheath 200, the large difference in force between the connection point and the sheath itself makes it difficult for the operator to precisely and quickly reduce the cutting force when cutting from the sheath seat 100 to the sheath 200 due to inertia. The novel delivery sheath provided in this embodiment features a force buffer 202 near the connection point between the sheath 200 and the sheath seat 100. A raised structure is designed on the sheath 200 within the buffer 202 to increase friction and / or resistance during cutting. This allows the force used to cut the buffer 202 to gradually decrease, preventing sudden changes and making the entire cutting process smoother. This reduces the difficulty of the surgeon's operation, lowers surgical risks, and avoids unnecessary harm to the patient. In one possible implementation, the raised structure causes the cutting resistance of the cutting tool in the buffer zone 202 to decrease from the side closer to the connection area 201 to the side closer to the implantation area 203. This design allows the cutting force to transition gently from the sheath seat to the sheath tube, further improving the smoothness of the cutting process.

[0052] The sheath 200 is formed axially from multiple segments of polymer material with varying hardness, the hardness of which decreases from the proximal end near the sheath seat 100 to the distal end away from the sheath seat 100. The connecting region 201 and the buffer zone 202 are located at the proximal end of the sheath 200, and the distal end of the sheath 200 is included in the implantation region 203, which refers to the area of ​​the sheath 200 that enters the patient's body to deliver the electrode wire. In one possible implementation, the sheath 200 is formed longitudinally from three segments of polymer material with varying hardness, such as... Figure 1 As shown, the sheath 200 includes a first part connected to the sheath seat 100, a second part in the middle, and a third part furthest from the sheath seat 100. The first part is made of a harder polymer material, the second part is made of a medium-hardness polymer material, and the third part is made of a softer polymer material. The material of the third part has a radiopaque effect. The change in hardness from far to near in the sheath 200 ensures operational safety and reduces complications such as cardiac perforation. The above example illustrates that the sheath 200 includes three segments of materials with different hardnesses. In actual manufacturing and use, the sheath 200 may include fewer or more segments of materials with different hardnesses. This disclosure does not limit the number of segments of materials with different hardnesses included in the sheath 200.

[0053] This embodiment utilizes multiple segments of polymer materials with varying hardness to fabricate the sheath 200, resulting in excellent flexibility. Specifically, the sheath 200 can be configured with various lengths and 3D bends ranging from 20cm to 50cm to accommodate pacing at different cardiac chamber locations. Traditional ventricular pacing leads are typically placed at or around the apex of the right ventricle, which may cause asynchronous ventricular contraction, increasing the risk of heart failure and atrial fibrillation. The sheath 200 in this disclosure, by developing a length and bend different from those used clinically, allows the electrode lead tip to be placed in the His bundle and left bundle branch, achieving better electromechanical synchronization compared to traditional right ventricular pacing, and offering advantages such as simple positioning and a long pacing device lifespan.

[0054] In one possible implementation, the protrusion structure includes a first protrusion 204, and the transition between the connecting region 201 and the implantation region 203 is achieved through a buffer 202 containing the first protrusion 204. In another possible implementation, the protrusion structure includes a second protrusion 205, and the transition between the connecting region 201 and the implantation region 203 is achieved through the second protrusion 205. In yet another possible implementation, the protrusion structure includes a first protrusion 204 and a second protrusion 205. The first protrusion 204 can be positioned close to the connecting region 201 or close to the implantation region 203. When the first protrusion 204 is positioned close to the connecting region 201, the second protrusion 205 is positioned close to the implantation region 203, and vice versa. Of course, the first protrusion 204 and the second protrusion 205 can also be spaced apart along the long axis of the sheath 200.

[0055] The number of first protrusions 204 can be one or more. When there is only one first protrusion 204, the thickness of the first protrusion 204 decreases from the side closer to the connecting region 201 to the side closer to the implantation region 203. When there are multiple first protrusions 204, the multiple first protrusions 204 are distributed at intervals along the axial direction of the sheath 200, and the thickness and / or length of the first protrusion 204 closer to the connecting region 201 is greater than the thickness and / or length of the first protrusion 204 closer to the implantation region 203, such as... Figure 2 As shown. The thickness of the first protrusion 204 refers to the wall thickness of the first protrusion 204 in the radial direction of the sheath 200, and the length of the first protrusion 204 refers to the length of the first protrusion 204 in the circumferential direction of the sheath 200.

[0056] In one possible implementation, the first protrusion 204 has a groove 206; the groove 206 is formed along the axial direction of the sheath 200 and recesses from the surface of the first protrusion 204 into the inner wall of the sheath 200. This groove 206 guides the cutting direction of the cutting tool to facilitate the user's cutting operation. It is important to note that the depth of the groove 206 is less than the wall thickness of the first protrusion 204, ensuring that the force required in the area of ​​the cutting buffer 202 where the first protrusion 204 is located is greater than the force required in the area of ​​the cutting buffer 202 where neither the first protrusion 204 nor the second protrusion 205 is located. In one possible implementation, the depth of the groove 206 can gradually increase from the side closer to the connection area 201 to the side closer to the implantation area 203, thus gradually reducing the required cutting force.

[0057] The buffer zone is provided with at least one set of second protrusions. Each second protrusion 205 includes a first protrusion 208 and a second protrusion 209. A gap 207 is provided between the first protrusion 208 and the second protrusion 209 to provide frictional resistance for the cutting tool. The width of the gap 207 increases from the side closer to the connecting area 201 to the side closer to the implantation area 203. By designing the width of the gap 207 to change gradually, the frictional force between the cutting tool and the gap 207 gradually decreases during the cutting process from the connecting area 201 to the implantation area 203, and the required cutting force also gradually decreases, thereby reducing the difference in force required to cut the implantation area 203 and making the cutting process smoother. In one possible implementation, the portion of the gap 207 near the connecting area 201 forms a flared opening. The flared opening design facilitates the reception of the cutting tool and guides the cutting direction of the tool.

[0058] When the buffer has multiple second protrusions, these protrusions are distributed around the inner circumference of the buffer, improving the tolerance of the cutting direction. Specifically, the multiple second protrusions can completely surround the inner wall of the buffer, so that the cutting blade will be guided into a gap regardless of the cutting direction; or, the multiple second protrusions can only surround a portion of the inner wall of the buffer. For example, when the buffer has a first protrusion 204 and a second protrusion 205, the second protrusions can be set to surround the area on the inner wall of the buffer adjacent to the first protrusion 204, so that when the cutting blade cuts the first and second protrusions, it can be guided into the gap even if there is a slight deviation in direction.

[0059] In one possible implementation, when the protrusion structure includes a first protrusion 204 and a second protrusion 205, the gap 207 of the second protrusion 205 is collinear with the groove 206 of the first protrusion 204. Both the gap 207 and the groove 206 serve to guide the cutting path of the cutting tool. By designing the gap 207 and the groove 206 to be collinear, the operator does not need to change the cutting path during the cutting operation, thus improving the convenience of operation.

[0060] In one possible implementation, the structure at the connection between the sheath 200 and the sheath seat 100 is as follows: Figure 2As shown, a first protrusion 204 and a second protrusion 205 are provided on the inner wall of the sheath 200 in the buffer zone 202 to increase the cutting resistance. There are three first protrusions 204, all with the same wall thickness. The length of the three protrusions decreases along the cutting direction, thus reducing the resistance. Each first protrusion 204 has a V-shaped groove 206, which facilitates cutting and guides the cutting blade. The second protrusion 205 includes a symmetrically arranged first protrusion 208 and a second protrusion 209. A gap 207 exists between the first protrusion 208 and the second protrusion 209. The cutting blade moves within the gap 207. During cutting, there is friction between the cutting blade and the first and second protrusions 208 and 209. The gap 207 has a flared design. The portion of the gap 207 near the connecting area 201 is wider, serving a guiding function. The portion of the gap 207 near the implantation area 203 becomes wider, gradually reducing the friction of the cutting blade. This structural design increases the friction and resistance between the cutting blade and the sheath 200 in the buffer zone 202, gradually reducing the force required by the doctor to cut in the buffer zone 202. This makes the entire cutting process smoother, reduces the difficulty of the doctor's operation, lowers the risk of surgery, and avoids unnecessary harm to the patient.

[0061] In existing technologies, the tip of the sheath is fixedly connected to the sheath seat. The tip of the sheath lacks a buffer zone with a raised structure, and the wall thickness of the same section of the sheath is almost uniform. Using rheoforming technology to manufacture the sheath can largely ensure rheological uniformity. The rheoforming technology for the sheath involves: melting the tubing at high temperature, inserting a metal mandrel inside the tubing, and covering the outer layer of the tubing with FEP heat-shrink tubing. External heating causes the heat-shrink tubing to shrink, restricting the tubing both internally and externally. After cooling, it solidifies and takes shape.

[0062] Different wall thicknesses of tubing require different extrusion temperatures. When the sheath 200 needs to have multiple protrusions, the wall thickness difference becomes significant. Using traditional rheological forming techniques to manufacture the sheath and extruding at the same temperature leads to processing defects such as uneven material rheology near the protrusions, insufficient filling, and air bubbles. This application achieves uniform extrusion by setting temperature control. Specifically, the tubing is preheated before entering the extruder, and a segmented temperature control section at the extruder head is used. Segmented temperature control means setting the extrusion temperature of the thicker portion of the sheath to be higher than that of the thinner portion, allowing the preheated tubing to be better suited for extrusion. The temperature difference between the thicker and thinner portions of the sheath is determined based on their thickness difference; for every 1mm increase in thickness difference, the temperature difference increases by 8℃-10℃. Meanwhile, due to the increased thickness, air bubbles are more likely to be generated during extrusion of the material tube. By adding multiple perforated venting structures to the die at the extruder head, venting is increased to prevent the generation of air bubbles.

[0063] Please see Figure 3 The sheath base 100 includes a sheath base body 102, a side branch 103, and a handle 104. The sheath base body 102 has a sheath cap interface 109, a sheath tube interface 101, and a channel 108 connecting the sheath tube interface 101 and the sheath cap interface 109. The handle 104 is connected to the sheath base body 102. One end of the side branch 103 passes through the channel 108 of the handle 104, and the other end of the side branch 103 has a Luer connector 106, which can be used to connect devices for air suction and injection of anticoagulants such as heparin. The channel 108 on the sheath base body 102 can deliver medical devices such as electrode leads to designated locations. The wall thickness of the side of the sheath base body 102 near the sheath tube interface 101 is less than the wall thickness of the side near the sheath cap interface 109, so that the cutting force required to cut the sheath base 100 gradually decreases. In addition, the sheath body 102 is provided with a cut 107 for a connecting channel 108, which extends from the sheath cap interface 109 to the sheath tube interface 101 for guiding the cutting blade. In one possible implementation, the cut 107 on the sheath body 102, the groove 206 on the first protrusion 204, and the gap 207 on the second protrusion 205 are collinear. When cutting, the cutting blade naturally transitions from the cut 107 to the groove 206 and the gap 207, improving the guiding effect on the cutting blade.

[0064] In one possible implementation, the pacemaker electrode lead delivery sheath also includes a hemostatic valve 300. The inlet 301 of the hemostatic valve 300 is located at the sheath cap interface 109, and the outlet 302 of the hemostatic valve 300 passes through the sheath cap interface 109 and enters the channel 108. The hemostatic valve 300 has an elastic structure 303 for covering the outlet 302. The elastic structure 303 can be opened by the pressure applied during device insertion to expose the outlet 302, and automatically closes to seal the outlet 302 after the pressure is released. The outlet 302 of the hemostatic valve 300 can be a hole located at the bottom of the hemostatic valve 300, and the diameter of the outlet 302 is smaller than the diameter of the inlet 301. The elastic structure 303 can be an elastic sheet. The material of the hemostatic valve 300 can be silicone. The hemostatic valve 300 has a central circular hole structure to facilitate the entry of dilators and other medical devices. The hemostatic valve 300 has an automatically closing elastic structure 303 on the side near the sheath 200. This elastic structure 303 only allows instruments to be inserted towards the sheath 200, enabling proper hemostasis without affecting the placement of the dilator. When an instrument is inserted, the elastic structure 303 opens, such as... Figure 6 As shown, after the instrument is removed, the elastic structure 303 can close automatically, as... Figure 7 As shown. Furthermore, a reinforcing rib 304 is provided on the outer periphery of the hemostatic valve 300 near the elastic structure 303, as shown. Figure 5 As shown, this reinforcing rib 304 can prevent air from entering the blood vessels during clinical negative pressure aspiration, and at the same time can enhance the self-closing of the elastic structure 303, resulting in better hemostasis.

[0065] The hemostatic valve 300 can be fixed to the sheath seat 100 by adhesive bonding, welding, or mechanical positioning. In one possible implementation, the hemostatic valve 300 is fixed to the sheath seat 100 by a sheath cap 400. Please refer to [link to relevant documentation]. Figure 8 The sheath cap 400 includes a sheath cap body 401, a locking slot 402, and an instrument channel 403. The sheath cap body 401 includes a top of the sheath cap 400 and an annular sidewall connecting to the top of the sheath cap 400. The locking slot 402 is formed on the annular sidewall, and the instrument channel 403 extends from the top of the sheath cap 400 to the annular sidewall. A locking block 105 is provided on the outer wall of the sheath seat body 102. See also... Figure 9 The outer edge of the inlet 301 of the hemostatic valve 300 abuts between the sheath cap interface 109 and the top of the sheath cap 400. The locking block 105 on the sheath seat 100 is inserted into the locking slot 402 of the sheath cap 400, thereby fixing the hemostatic valve 300 on the sheath seat 100.

[0066] Note that the above description is merely a preferred embodiment of the present invention and the technical principles employed. Those skilled in the art will understand that the present invention is not limited to the specific embodiments described herein, and various obvious changes, readjustments, and substitutions can be made without departing from the scope of protection of the present invention. Therefore, although the present invention has been described in detail through the above embodiments, the present invention is not limited to the above embodiments, and may include many other equivalent embodiments without departing from the concept of the present invention, the scope of which is determined by the scope of the appended claims.

Claims

1. A cardiac pacemaker electrode lead delivery sheath, characterized in that, include: Sheath base, equipped with sheath tube interface; The sheath includes a connecting area, a buffer zone, and an implantation zone arranged sequentially along the axial direction. The connecting area is fixedly connected to the sheath interface. The buffer zone connects the connecting area and the implantation zone. The inner wall of the buffer zone is provided with a protruding structure. The protruding structure makes the cutting resistance of the cutting tool in the buffer zone between the cutting resistance of the sheath seat and the implantation zone. The protrusion structure includes a first protrusion extending along the inner circumference of the inner wall, thereby being cut when the cutting tool cuts the buffer zone; the number of the first protrusion is one, and the thickness of the first protrusion decreases from the side closer to the connection area to the side closer to the implantation area; or, the number of the first protrusion is multiple, and the multiple first protrusions are distributed at intervals along the axial direction of the sheath, and the thickness and / or length of the first protrusion closer to the connection area is greater than the thickness and / or length of the first protrusion closer to the implantation area; The first protrusion has a groove for guiding the cutting direction of the cutting tool; the groove is opened along the axial direction of the sheath and is recessed from the surface of the first protrusion toward the inner wall of the sheath.

2. The cardiac pacemaker electrode lead delivery sheath according to claim 1, characterized in that, The protrusion structure includes a second protrusion, which includes a first protrusion portion and a second protrusion portion, with a gap between the first protrusion portion and the second protrusion portion. The width of the gap is configured to clamp the cutting tool, thereby providing frictional resistance when the cutting tool cuts the buffer zone.

3. The cardiac pacemaker electrode lead delivery sheath according to claim 2, characterized in that, The width of the gap increases from the side closer to the connection area to the side closer to the implantation area; and / or The portion of the gap near the connection area forms a flared opening.

4. The cardiac pacemaker electrode lead delivery sheath according to claim 2, characterized in that, The second protrusion includes multiple sets arranged around the inner wall.

5. A cardiac pacemaker electrode lead delivery sheath, characterized in that, include: Sheath base, equipped with sheath tube interface; The sheath includes a connecting area, a buffer zone, and an implantation zone arranged sequentially along the axial direction. The connecting area is fixedly connected to the sheath interface. The buffer zone connects the connecting area and the implantation zone. The inner wall of the buffer zone is provided with a protruding structure, which includes a first protrusion and a second protrusion. The first protrusion extends along the inner circumference of the inner wall so that it can be cut when a cutting tool cuts the buffer zone. The second protrusion includes a first protruding portion and a second protruding portion. There is a gap between the first protruding portion and the second protruding portion. The width of the gap is configured to clamp the cutting tool so as to provide frictional resistance when the cutting tool cuts the buffer zone. The first protrusion has a groove for guiding the cutting direction of the cutting tool. The groove corresponds to the gap. The protruding structure makes the resistance of the cutting tool in the buffer zone between the resistance of the sheath seat and the implantation zone.

6. The cardiac pacemaker electrode lead delivery sheath according to claim 5, characterized in that, The sheath is formed by processing multiple sections of polymer material with different hardness in the axial direction, and the hardness of the sheath decreases from the proximal end near the sheath seat to the distal end away from the sheath seat.

7. The cardiac pacemaker electrode lead delivery sheath according to claim 5, characterized in that, The sheath base includes a sheath base body, a side support, and a handle. The sheath base body has a sheath cap interface, a sheath tube interface, and a channel connecting the sheath tube interface and the sheath cap interface. The handle is connected to the sheath base body, and the side support passes through the handle and connects to the channel. The wall thickness of the sheath tube body on the side near the sheath tube interface is less than the wall thickness on the side near the sheath cap interface.

8. The cardiac pacemaker electrode lead delivery sheath according to claim 7, characterized in that, It also includes a hemostatic valve, the inlet of which is located at the sheath cap interface, and the outlet of which passes through the sheath cap interface and enters the channel; The hemostatic valve is provided with an elastic structure for shielding the outlet. The elastic structure can be opened by top pressure to expose the outlet, and automatically closes to seal the outlet after the top pressure is released. The outer periphery of the hemostatic valve is provided with reinforcing ribs near the elastic structure.

9. The cardiac pacemaker electrode lead delivery sheath according to claim 8, characterized in that, The hemostatic valve is fixed to the sheath cap interface by a sheath cap. The sheath cap includes a sheath cap body, a bayonet, and an instrument channel. The sheath cap body includes a sheath cap top and an annular sidewall connecting the sheath cap top. The bayonet is formed on the annular sidewall, and the instrument channel extends from the sheath cap top to the annular sidewall. The outer wall of the sheath seat body is provided with a locking block, and the outer edge of the inlet of the hemostatic valve abuts between the sheath cap interface and the top of the sheath cap, and the locking block is inserted into the locking slot of the sheath cap.

10. A method for preparing a cardiac pacemaker electrode lead delivery sheath according to any one of claims 1-9, characterized in that, When using an extruder to manufacture sheaths, the head end of the extruder is subjected to segmented temperature control. The segmented temperature control means that the extrusion temperature of the thicker portion of the sheath is greater than the extrusion temperature of the thinner portion of the sheath.

11. The method for preparing the cardiac pacemaker electrode lead delivery sheath according to claim 10, characterized in that, The temperature difference between the extrusion temperature of the thicker portion of the sheath and the extrusion temperature of the thinner portion of the sheath is determined based on the thickness difference between the thicker portion of the sheath and the thinner portion of the sheath. For every 1 mm increase in the thickness difference, the temperature difference increases by 8℃-10℃.

12. The method for preparing the cardiac pacemaker electrode lead delivery sheath according to claim 10 or 11, characterized in that, Multiple perforated venting structures are added to the die at the head end of the extruder.

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