Integrated pulse generator

By using an integrated pulse generator to fix the electrode wires to the pulse generation circuit and using a rotatable coil to adjust the length of the electrode wires, the increased complexity and friction problems of connectors in the prior art are solved, achieving reduced size and improved safety.

WO2025246738A1PCT designated stage Publication Date: 2025-12-04MICROPORT SORIN CRM (SHANGHAI) CO LTD
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Patent Information

Application Number
PCT/CN2025/090599
Authority / Receiving Office
WO · WO
Patent Type
Applications
Current Assignee / Owner
Priority Date
2024-05-31
Filing Date
2025-04-23
Publication Date
2025-12-04

AI Technical Summary

Technical Problem

Existing medical pulse generators are connected to electrode wires via IS-1 connectors, which increases design complexity and failure risk. Furthermore, friction and irregular coiling of the electrode wires within the capsule can cause insulation layer cracks or breaks, affecting aesthetics and safety.

Method used

Design an integrated pulse generator by fixing the electrode wires to the pulse generation circuit and adjusting the length of the electrode wires using a rotatable coiling component, eliminating the need for connectors, and regularly coiling the electrode wires to reduce friction and sac volume.

Benefits of technology

It eliminates the risk of connector failure, reduces the size of the pulse generator, prevents electrode wire friction, improves ease of operation and safety, and reduces the size of the bladder.

✦ Generated by Eureka AI based on patent content.

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Abstract

The present invention provides an integrated pulse generator, which comprises: a coiled piece, a pulse generating circuit, and an electrode wire. The coiled piece has an inner cavity and a communication hole, and the communication hole is in communication with the inner cavity and the outside of the coiled piece. The pulse generating circuit is housed in the inner cavity and fixedly connected to one end of the electrode wire, and the other end of the electrode wire penetrates through the communication hole and out of the inner cavity, coils around the coiled piece, and then extends toward an implantation site. The coiled piece is rotatably arranged with its own axis as the axis of rotation so as to adjust the length of the electrode wire coiled around it, thereby adjusting the extension length of the electrode wire extending toward the implantation site. By means of the configuration, the need for a connector between the electrode wire and the pulse generator is eliminated, and the step of physically inserting a traditional electrode wire into the pulse generator is also omitted. This not only reduces the volume of the pulse generator, but also completely eliminates various poor connection issues caused by connector insertion faults between the traditional pulse generator and the electrode wire.
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Description

Integrated pulse generator Technical Field

[0001] This invention relates to the field of medical device technology, and in particular to an integrated pulse generator. Background Technology

[0002] In existing technologies, medical pulse generators (such as pacemakers) and electrode leads are usually two separate components. In clinical use, they are typically connected via a dedicated IS-1 connector. After connection, the electrode leads transmit signals (such as pacing and sensing signals) between the body and the pulse generator. Since electrode leads are generally non-customized products, a certain length of redundant end usually protrudes from the implantation incision after implantation. After connection to the pulse generator, the redundant length of electrode lead is usually coiled around the surface of the pulse generator and placed together with the pulse generator inside the pocket.

[0003] However, using IS-1 connectors for mechanical and electrical connections requires setting IS-1 connector plugs on the electrode wires and IS-1 connector slot cavities on the pulse generator. This undoubtedly increases the complexity of the design and manufacturing of the electrode wires and pulse generator, increases the risk of failure due to poor IS-1 connector connection, and the IS-1 connector occupies about 1 / 3 of the space of the pulse generator, making it difficult to reduce the size of the pulse generator.

[0004] Furthermore, the electrode wires coiled around the pulse generator, once inserted into the confined space of the pouch, will rub against the metal casing of the pulse generator as the body moves. Prolonged friction can lead to insulation breakdown and even conductor breakage. More importantly, the lack of a proper coiling mechanism results in irregular coiling of the electrode wires, with different operators using different methods, leading to varying curvatures. Even well-coiled wires can become tangled and disorganized during insertion into the pouch. This further increases the risk of insulation breakdown or wire breakage at points of excessive bending under prolonged stress. Additionally, it can cause bulges in the pouch area, potentially leading to skin abrasion and affecting aesthetics. Summary of the Invention

[0005] The purpose of this invention is to provide an integrated pulse generator to solve the problem that existing pulse generators need to be connected to electrode wires via connectors.

[0006] To solve the above-mentioned technical problems, the present invention provides an integrated pulse generator, characterized in that it includes: a coiled component, a pulse generating circuit, and electrode wires;

[0007] The coiled component has an inner cavity and a connecting hole, the connecting hole connecting the inner cavity and the outside of the coiled component; the pulse generating circuit is housed in the inner cavity and fixedly connected to one end of the electrode wire, the other end of the electrode wire passes through the connecting hole out of the inner cavity, coils around the coiled component and extends toward the implantation site;

[0008] The coiled component is rotatably arranged around its own axis to accommodate the length of the electrode wire coiled on it, thereby adjusting the extension length of the electrode wire extending to the implantation site.

[0009] Optionally, the integrated pulse generator further includes a base having a receiving cavity, a portion of the coiling member being rotatably disposed in the receiving cavity, and the area of ​​the coiling member for winding the electrode wire being located within the receiving cavity;

[0010] The substrate has an outlet hole, and the other end of the electrode wire passes through the outlet hole after leaving the coiled part, exits the receiving cavity, and extends toward the implantation site.

[0011] Optionally, the substrate has a guide groove, and the other end of the electrode wire passes through the guide groove after leaving the coiled part, and then exits the receiving cavity through the lead-out hole.

[0012] Optionally, the lead-out hole is opened along the axial direction of the coil, and / or the guide groove is opened in a direction perpendicular to the axis of the coil.

[0013] Optionally, the substrate has a base that abuts against the coiled part, and the guide groove is formed on the side of the base that abuts against the coiled part; the lead-out hole is formed on the base and communicates with the guide groove.

[0014] Optionally, the integrated pulse generator further includes a guide post disposed within the accommodating cavity; the other end of the electrode wire leaves the coil and is wound around the guide post to change its extension direction, and then passes through the lead-out hole to exit the accommodating cavity.

[0015] Optionally, the integrated pulse generator further includes a locking device connected to the base for locking the rotation of the coiled component relative to the base.

[0016] Optionally, the coil has circumferentially arranged ratchet teeth, and the locking device includes an engaging member adapted to the ratchet teeth for engaging with the ratchet teeth to lock the rotation of the coil in the direction of releasing the electrode wire.

[0017] Optionally, the locking device further includes a potential energy section for applying a potential force to the engaging member so that the engaging member engages with the ratchet when not subjected to external force.

[0018] Optionally, the portion of the coiled member extending out of the receiving cavity has an anti-slip feature; and / or

[0019] The integrated pulse generator is used for a temporary cardiac pacemaker, and the diameter of the electrode leads is 0.15 mm to 2 mm.

[0020] In summary, the integrated pulse generator provided by the present invention includes: a coiled component, a pulse generating circuit, and an electrode wire; the coiled component has an inner cavity and a connecting hole, the connecting hole connecting the inner cavity and the outside of the coiled component; the pulse generating circuit is housed in the inner cavity and fixedly connected to one end of the electrode wire, the other end of the electrode wire passing through the connecting hole through the inner cavity, coiling around the coiled component and extending towards the implantation site; the coiled component is rotatably arranged about its own axis to adjust the length of the electrode wire coiled on it, thereby adjusting the extension length of the electrode wire extending towards the implantation site.

[0021] This configuration directly connects the electrode wires to the pulse generation circuit, forming an integrated pulse generator. This eliminates the need for a connector between the electrode wires and the pulse generator, as well as the traditional physical connection steps between the electrode wires and the pulse generator. This not only reduces the size of the pulse generator but also completely eliminates various connection problems caused by connector failures in traditional pulse generators and electrode wires.

[0022] In addition, since the length of the electrode wire can be adjusted by rotating around the axis, redundant electrode wires can be easily and regularly wound on the winding component. This not only prevents the electrode wires from rubbing against other parts later, making the operation convenient and quick, but also effectively reduces the volume of the bag. Attached Figure Description

[0023] Those skilled in the art will understand that the accompanying drawings are provided to better understand the invention and do not constitute any limitation on the scope of the invention. Wherein:

[0024] Figure 1 is a schematic axial cross-sectional view of an integrated pulse generator according to an embodiment of the present invention.

[0025] Figure 2 is a schematic diagram of the coiled component according to an embodiment of the present invention.

[0026] Figure 3 is a schematic diagram of the substrate according to an embodiment of the present invention.

[0027] In the attached image:

[0028] 10-Coiled part; 100-Inner cavity; 101-Connecting hole; 11-Upper cover; 12-Lower cover; 13-Coiled groove; 14-Ratchet; 15-Anti-slip feature; 20-Electrode wire; 21-Ring electrode; 22-Head electrode; 30-Base; 300-Accommodating cavity; 301-Lead-out hole; 302-Expansion area; 31-Guide groove; 32-Chassis; 33-Guide post; 40-Locking device; 41-Snap-fitting part; 411-Arc-shaped abutment surface; 42-Potential energy part; 421-Spring; 50-Pulse generating circuit. Detailed Implementation

[0029] To make the objectives, advantages, and features of this invention clearer, the invention will be further described in detail below with reference to the accompanying drawings and specific embodiments. It should be noted that the drawings are all in a very simplified form and are not drawn to scale, and are only used to facilitate and clarify the explanation of the embodiments of this invention. Furthermore, the structures shown in the drawings are often part of the actual structures. In particular, different figures may emphasize different aspects and may sometimes use different scales.

[0030] As used in this invention, the singular forms "a," "an," "one," and "the" include plural objects; the term "or" is generally used to mean "and / or"; the term "a number" is generally used to mean "at least one"; the term "at least two" is generally used to mean "two or more"; furthermore, the terms "first," "second," and "third" are used for descriptive purposes only and should not be construed as indicating or implying relative importance or implicitly specifying the number of indicated technical features. Thus, a feature defined as "first," "second," or "third" may explicitly or implicitly include one or at least two of that feature; "one end" and "the other end," and "proximal end" and "distal end" generally refer to two corresponding parts, which include not only endpoints. Furthermore, as used in this invention, the terms "installed," "connected," and "attached," or "set" on one element from another, should be interpreted broadly. They generally only indicate a connection, coupling, cooperation, or transmission relationship between two elements, which can be direct or indirect through intermediate elements. They should not be construed as indicating or implying a spatial relationship between the two elements, meaning one element can be located inside, outside, above, below, or to one side of another element, unless otherwise explicitly stated. Those skilled in the art can understand the specific meaning of these terms in this invention according to the specific circumstances. Additionally, directional terms such as above, below, up, down, upward, downward, left, and right are used relative to exemplary embodiments as shown in the figures, with upward or up direction pointing towards the top of the corresponding figure, and downward or down direction pointing towards the bottom of the corresponding figure.

[0031] The purpose of this invention is to provide an integrated pulse generator to solve the problem that existing pulse generators require connection to electrode wires via connectors. The following description refers to the accompanying drawings.

[0032] Please refer to Figures 1 to 3. This embodiment of the invention provides an integrated pulse generator, comprising: a coiled component 10, a pulse generating circuit 50, and an electrode wire 20. The coiled component 10 has an inner cavity 100 and a connecting hole 101, the connecting hole 101 connecting the inner cavity 100 and the outside of the coiled component 10. The pulse generating circuit 50 is housed in the inner cavity 100 and fixedly connected to one end of the electrode wire 20. The other end of the electrode wire 20 passes through the connecting hole 101, exits the inner cavity 100, coils around the coiled component 10, and extends towards the implantation site. The coiled component 10 is rotatably configured about its own axis as a pivot A to adjust the length of the electrode wire 20 coiled thereon, thereby adjusting the extension length of the electrode wire 20 towards the implantation site. For ease of description, the end of the electrode wire 20 fixedly connected to the pulse generating circuit 50 is referred to as the proximal end of the electrode wire 20, and the other end of the electrode wire 20 relative to the proximal end is referred to as the distal end of the electrode wire 20. In one embodiment, the distal portion of the electrode lead 20 has a ring electrode 21 and a head electrode 22, which can be used for cardiac pacing and sensing. The specific structure and principle of these electrodes can be found in the prior art.

[0033] This configuration directly and fixedly connects the electrode wire 20 to the pulse generation circuit 50, forming an integrated pulse generator. This eliminates the need for a connector between the electrode wire 20 and the pulse generator, as well as the traditional physical insertion step. This not only reduces the size of the pulse generator but also completely eliminates various connection problems caused by connector failures in traditional pulse generators and electrode wires 20. Furthermore, since the winding member 10 can adjust the winding length of the electrode wire 20 by rotating around its axis, redundant electrode wires 20 can be easily and regularly wound on the winding member 10. This prevents subsequent friction between the electrode wire 20 and other parts, making operation convenient and quick, and effectively reducing the bag volume.

[0034] In one embodiment, the coiled component 10 includes an upper cover 11 and a lower cover 12, both of which are in a rotational shape around axis A, such as cylindrical, frustum-shaped, or conical. After the upper cover 11 and lower cover 12 are assembled and fixed as a single unit, their interiors enclose an inner cavity 100. Optionally, the integrated pulse generator also includes a battery (not shown). Both the battery and the pulse generation circuit 50 are disposed within the inner cavity 100. The specific structure and connection principle of the battery and the pulse generation circuit 50 can be found in existing technologies and will not be elaborated upon in this embodiment. The proximal end of the electrode wire 20 can be soldered to the pulse generation circuit 50, for example, to achieve physical fixation and electrical conduction.

[0035] Optionally, the electrode wire 20 is wound around the coiled member 10 in the circumferential direction. Since the proximal end of the electrode wire 20 passes through the connecting hole 101 into the inner cavity 100 and is fixedly connected to the pulse generating circuit 50, it is equivalent to the proximal end of the electrode wire 20 being fixed relative to the coiled member 10, while the distal end of the electrode wire 20 extends after being wound around the coiled member 10. It can be understood that when the coiled member 10 rotates around the rotating shaft A, the electrode wire 20 can be released or retracted, so that the extension length of the distal end of the electrode wire 20 is adjustable.

[0036] In an alternative example, the winding member 10 has a circumferentially recessed winding groove 13 for winding the electrode wire 20 and for limiting the electrode wire 20. The winding groove 13 may, for example, be formed on the lower cover 12. The winding groove 13 may be a relatively wide groove that allows the electrode wire 20 to be wound several turns. The winding groove 13 may also be a helical groove corresponding to the electrode wire 20, with the groove width corresponding to the outer diameter of the electrode wire 20. The number of turns of the electrode wire 20 wound on the winding member 10 is unlimited.

[0037] Furthermore, the connecting hole 101 is formed in the area of ​​the coiled member 10 for coiling the electrode wire 20, that is, in the area corresponding to the coiling groove 13. In one embodiment, the connecting hole 101 is formed radially along the coiled member 10. In another embodiment, the connecting hole 101 is not limited to being a straight hole; it can also be an arc-shaped hole or an oblique hole, which can reduce the degree of angle change when the electrode wire 20 passes through the coiling groove 13 into the inner cavity 100. Preferably, the diameter of the connecting hole 101 is adapted to the outer diameter of the electrode wire 20, for example, it can be slightly larger than the outer diameter of the electrode wire 20, so as to facilitate the insertion of the electrode wire 20 and facilitate sealing after the electrode wire 20 is inserted.

[0038] Optionally, the integrated pulse generator further includes a base 30 having a receiving cavity 300. A portion of the coiled member 10 is rotatably disposed in the receiving cavity 300, and the area of ​​the coiled member 10 for coiling the electrode wire 20 is located within the receiving cavity 300. The base 30 has a lead-out hole 301, through which the distal end of the electrode wire 20 exits the receiving cavity 300 after leaving the coiled member 10 and extends towards the implantation site. The base 30 encloses the area of ​​the coiled member 10 for coiling the electrode wire 20, thus confining the redundant length of the electrode wire 20 within the receiving cavity 300, further improving the regularity of the electrode wire 20's placement and reducing friction between the electrode wire 20 and other components or tissues. Preferably, the shape of the receiving cavity 300 restricts the axial and radial positions of the coiled member 10, allowing only rotation of the coiled member 10 about axis A within it. The location of the lead-out hole 301 can be configured according to the application scenario of the integrated pulse generator.

[0039] In one application scenario, the integrated pulse generator of this embodiment is used for a temporary cardiac pacemaker, where its main body (including the coil 10 and the base 30, etc.) is installed externally, for example, attached to the skin of the chest, while the distal portion of the electrode lead 20 can be extended to the implantation site (such as the heart chamber) after puncture. Corresponding to such an application scenario, it may be necessary to change the extension direction of the electrode lead 20 after it leaves the coil 10, and correspondingly configure the opening position and direction of the exit hole 301 to facilitate the distal end of the electrode lead 20 entering the implantation site through the puncture hole. In the exemplary example shown in Figure 1, the extension direction of the electrode lead 20 after leaving the coil 10 is approximately along the circumference of the coil 10, while the entire main body of the temporary cardiac pacemaker is attached to the body surface approximately along axis A. The electrode lead 20 needs to enter the human body along the axial direction of the coil 10; therefore, it is preferable to use some guiding structures to change, transition, guide, and restrict the extension direction of the electrode lead 20.

[0040] It should be noted that the integrated pulse generator provided in this embodiment is not limited to use in temporary pacemakers; in some applications, it can also be used in permanent pacemakers (i.e., implantable pacemakers). It also has the advantage of eliminating the connectors found in existing technologies. Furthermore, it reduces or avoids the risk of pocket infection.

[0041] In an alternative example, the substrate 30 has a base 32 abutting against the coil 10, with the side of the base 32 away from the coil 10 for attachment to the body surface. The exit hole 301 is formed in the base 32. Further, the exit hole 301 is formed along the axial direction of the coil 10, preferably along axis A. It is understood that the exit hole 301 can alter and restrict the extension direction of the electrode lead 20. The exit hole 301 being formed along the axial direction of the coil 10 causes the electrode lead 20 to be redirected to extend axially after exiting, thus being particularly suitable for direct insertion into the implantation site (e.g., the heart chamber) via puncture. Preferably, the electrode lead 20 is a solid wire, i.e., it may not have an axial cavity. Compared to the separate electrode leads with connectors in the prior art, the electrode lead 20 in this embodiment does not require an inner cavity for the plastic guidewire to pass through, thus it can be configured to be relatively thinner, making it easier to directly enter the heart chamber via puncture along the axial direction of the coil 10. Preferably, the diameter of the electrode lead 20 is 0.15mm to 2mm, for example, 0.15mm, 0.2mm, 0.3mm, 0.4mm, 0.5mm, 0.6mm, 0.7mm, 0.8mm, 1mm, 1.2mm, 1.5mm, or 2mm. Furthermore, because the electrode lead 20 can be configured to be relatively thin, the puncture site on the patient's body surface can also be relatively small, resulting in less or no wound exudation. This facilitates the direct adhesion of the wound surface to the side of the base 32 away from the coil 10, ensuring that the wound does not exude fluid and the electrode lead 20 is completely concealed.

[0042] However, when the electrode wire 20 leaves the coiled part 10, it is located approximately at the outer periphery of the coiled part 10. If the substrate 30 directly opens the lead-out hole 301 at the corresponding outer periphery of the coiled part 10, the lead-out hole 301 is located at the edge of the substrate 30, which is not conducive to covering the puncture site.

[0043] Based on this, referring to Figures 1 and 3, preferably, the substrate 30 has a guide groove 31. The distal end of the electrode wire 20 passes through the guide groove 31 after leaving the coiled member 10, and then exits the receiving cavity 300 through the exit hole 301. The guide groove 31 guides the electrode wire 20 to the middle position of the base 32, for example, corresponding to the position of axis A, and then turns and extends along the direction of axis A to exit through the exit hole 301. Thus, when the base 32 is attached to the body surface, the electrode wire 20 and the puncture site can be completely covered, thus eliminating the need for wound dressing. Furthermore, the guide groove 31 allows the electrode wire 20 coiled on the coiled member 10 to be smoothly transitioned to the exit hole 301, reducing the compression and friction on the exit hole 301 and reducing the risk of the electrode wire 20 getting stuck or breaking. The lead-out hole 301 is connected to the guide groove 31, and preferably an arc-shaped transition is provided at the connection between the lead-out hole 301 and the guide groove 31 to reduce friction and compression on the electrode wire 20.

[0044] The orientation of the guide groove 31 can be adjusted according to the shape of the base 30 and the position of the lead-out hole 301. In some embodiments, when the thickness of the chassis 32 is large, the guide groove 31 can be arranged at an angle to the axis A (i.e., not parallel), for example, extending obliquely. Preferably, the guide groove 31 is opened in a direction perpendicular to the axis A. It should be understood that the guide groove 31 being opened in a direction perpendicular to the axis A does not limit the guide groove 31 to passing through the axis A, but can form a perpendicular relationship with the axis A. In particular, the guide groove 31 is not limited to being a straight groove. For example, the guide groove 31 can be an arc-shaped groove or a curved groove on a plane perpendicular to the axis A. More preferably, the guide groove 31 intersects the axis A perpendicularly, that is, the guide groove 31 extends radially along the coiled member 10 and connects with the lead-out hole 301 at the position of the axis A. In some embodiments, the guide groove 31 can be opened on the inner surface of the side of the chassis 32 that abuts against the coiled member 10, that is, the guide groove 31 is an exposed groove, which facilitates the laying and installation of the electrode wire 20. In other embodiments, the guide groove 31 may also be formed within the wall of the chassis 32, i.e., the guide groove 31 is a concealed groove, which can strongly define the position of the electrode wire 20. Those skilled in the art can configure the guide groove 31 according to actual conditions, and this embodiment is not limited in this respect.

[0045] Preferably, the integrated pulse generator further includes a guide post 33, which is disposed within the accommodating cavity 300 and fixedly connected to the base 30. The distal end of the electrode wire 20, after leaving the coiled member 10, is wound around the guide post 33 to change its extension direction, and then passes through the lead-out hole 301 to exit the accommodating cavity 300. In an alternative example, the accommodating cavity 300 is not a circle with the exact same shape as the coiled member 10, but may have an enlarged region 302. After the coiled member 10 is installed in the accommodating cavity 300, a cavity is formed in the enlarged region 302, in which the guide post 33 can be installed. Preferably, the guide post 33 is arranged parallel to the axis A. It is understood that the electrode wire 20 can change its extension direction by being wound around the guide post 33.

[0046] Preferably, the guide post 33 can be provided together with the guide groove 31. After the distal end of the electrode wire 20 leaves the coiled part 10, it is wound around the guide post 33, changes its extension direction, and is guided into the guide groove 31. It is understood that the guide post 33 can be a smooth column or may include structures such as pulleys; this embodiment is not limited to this. The combination of the guide post 33 and the guide groove 31 further improves the guiding and transitioning effect on the electrode wire 20 and further reduces the risk of compression and friction on the electrode wire 20.

[0047] Optionally, the integrated pulse generator further includes a locking device 40, which is connected to the base 30 and used to lock the rotation of the coiled member 10 relative to the base 30. It is understood that rotation of the coiled member 10 will cause a change in the extension length of the electrode wire 20. In use, it is generally necessary to keep the electrode wire 20 stable after it extends to the implantation site, that is, it is desirable that the extension length of the electrode wire 20 no longer changes. The locking device 40 locks the rotation of the coiled member 10, thereby keeping the extension length of the electrode wire 20 fixed.

[0048] Furthermore, the locking device 40 has a locked state and an unlocked state. When the locking device 40 is in the locked state, it locks the rotation of the coiled member 10. In one embodiment, when the locking device 40 is in the locked state, it can lock only the rotation of the coiled member 10 in one direction (e.g., lock counterclockwise rotation), while allowing rotation in another direction (e.g., lock clockwise rotation). Further, the locked rotation direction of the coiled member 10 preferably corresponds to the direction in which the electrode wire 20 is released; that is, after the coiled member 10 is locked, the electrode wire 20 cannot be released, ensuring that the electrode wire 20 coiled on the coiled member 10 will not be pulled out unintentionally. In another embodiment, when the locking device 40 is in the locked state, it can lock the rotation of the coiled member 10 in all directions; that is, the rotation of the coiled member 10 is locked regardless of whether it is clockwise or counterclockwise. When the locking device 40 is in the unlocked state, it allows the coiled member 10 to rotate, thereby allowing adjustment of the extension length of the electrode wire 20.

[0049] Referring to Figures 1 and 2, in an alternative example, the coil 10 has circumferentially arranged ratchet teeth 14, and the locking device 40 includes an engaging member 41 adapted to the ratchet teeth 14 for engaging with the ratchet teeth 14 to lock rotation of the coil 10 in the direction of releasing the electrode wire 20. Preferably, the coil 10 has a plurality of ratchet teeth 14, which are evenly arranged circumferentially around the coil 10. Preferably, the engaging member 41 and at least one of the ratchet teeth 14 have an arcuate abutment surface 411 to reduce resistance to relative sliding between them.

[0050] In the example shown in Figure 2, the ratchet 14 is tilted counterclockwise. When the ratchet 14 engages with the engaging member 41, the locking device 40 is locked, preventing the coiled member 10 from rotating counterclockwise while allowing it to rotate clockwise. When the engaging member 41 disengages from the ratchet 14, the locking device 40 is unlocked, and the rotation of the coiled member 10 is unrestricted. In use, the engaging member 41 can be disengaged from the ratchet 14 first, and the electrode wire 20 can be pulled out to a certain length. Then, the engaging member 41 can be engaged with the ratchet 14. After the distal end of the electrode wire 20 is implanted into the target implantation site, the coiled member 10 is rotated clockwise, causing the redundant length of the electrode wire 20 to coil around the coiled member 10 until a suitable state is achieved.

[0051] Preferably, the locking device 40 further includes a potential energy portion 42, which applies a potential energy to the engaging member 41 so that the engaging member 41 engages with the ratchet 14 when no external force is applied. This potential energy may include elastic potential energy or magnetic potential energy, and the corresponding potential energy portion 42 may include an elastic element or a magnetic element. The following description uses an example where the potential energy portion 42 includes an elastic element. In an alternative example, the elastic element is a spring 421, and the engaging member 41 is a columnar member movably disposed radially along the coiled member 10, having an arc-shaped abutment surface 411 (such as a spherical head) at one end facing the coiled member 10. The spring 421 is sleeved outside the engaging member 41, with one end connected to the engaging member 41 and the other end connected to the base 30. Spring 421 is pre-compressed or pre-stretched, thus pre-storing elastic potential energy. When the engaging member 41 is not subjected to external force, the pre-stored elastic potential energy of spring 421 keeps the engaging member 41 engaged with ratchet 14. When unlocking is required, the engaging member 41 can be pulled away from the coiled member 10, causing the engaging member 41 to disengage from ratchet 14. At this time, spring 421 is further compressed or stretched, thus further storing elastic potential energy. Subsequently, after the engaging member 41 is released, it moves towards the coiled member 10 under the action of the elastic potential energy of spring 421 until it engages with ratchet 14.

[0052] In some other embodiments, the potential energy section 42 may include magnetic elements, such as magnetic elements arranged opposite each other, so that the magnetic repulsion between the two is used as the magnetic potential energy to drive the engagement of the engaging member 41 and the ratchet 14. Those skilled in the art can understand and configure this according to the prior art.

[0053] It should be noted that the combination of ratchet 14 and engaging member 41 shown above is merely an example of the locking device 40 and not a limitation thereof. In other embodiments, the locking device 40 may also include other structures with similar functions, such as threaded locking structures, snap-locking structures, and other locking structures commonly found in the art; this embodiment is not limited to these.

[0054] Referring to Figure 2, optionally, the portion of the coiled member 10 extending out of the receiving cavity 300 has an anti-slip feature 15. The anti-slip feature 15 may include anti-slip grooves, anti-slip protrusions, anti-slip patterns, or be constructed using anti-slip materials. Those skilled in the art can select at least one of these for configuration based on actual needs. The anti-slip feature 15 increases the gripping friction during operation, facilitating the application of force.

[0055] In summary, the integrated pulse generator provided by this invention includes: a coiled component, a pulse generating circuit, and electrode wires; the coiled component has an inner cavity and a connecting hole, the connecting hole connecting the inner cavity and the outside of the coiled component; the pulse generating circuit is housed in the inner cavity and fixedly connected to one end of the electrode wire, the other end of the electrode wire passing through the connecting hole and exiting the inner cavity, coiling around the coiled component and extending towards the implantation site; the coiled component is rotatably configured about its own axis to adjust the length of the electrode wire coiled on it, thereby adjusting the extension length of the electrode wire extending towards the implantation site. This configuration directly and fixedly connects the electrode wire to the pulse generating circuit, forming an integrated pulse generator. This eliminates the need for a connector between the electrode wire and the pulse generator, and also eliminates the traditional physical insertion step between the electrode wire and the pulse generator. This not only reduces the size of the pulse generator but also completely eliminates various connection problems caused by connector failures in traditional pulse generators and electrode wires. Furthermore, since the winding component can adjust the length of the electrode wire winding by rotating around its axis, redundant electrode wires can be easily and regularly wound onto the winding component. This not only prevents subsequent friction between the electrode wires and other parts, making operation convenient and quick, but also effectively reduces the volume of the bag.

[0056] It should be noted that the above embodiments can be combined with each other. The above description is only a description of preferred embodiments of the present invention and is not intended to limit the scope of the present invention in any way. Any changes or modifications made by those skilled in the art based on the above disclosure shall fall within the protection scope of the present invention.

Claims

1. An integrated pulse generator, characterized in that, include: Coiled components, pulse generating circuit, and electrode wires; The coiled part has an inner cavity and a connecting hole, the connecting hole connecting the inner cavity and the outside of the coiled part; The pulse generating circuit is housed in the inner cavity and fixedly connected to one end of the electrode wire; the other end of the electrode wire passes through the connecting hole, exits the inner cavity, and extends towards the implantation site after being coiled around the coiled part. The coiled component is rotatably arranged around its own axis to accommodate the length of the electrode wire coiled on it, thereby adjusting the extension length of the electrode wire extending to the implantation site.

2. The integrated pulse generator according to claim 1, characterized in that, The integrated pulse generator also includes a base having a receiving cavity, a portion of the coiling member being rotatably disposed in the receiving cavity, and the area of ​​the coiling member for winding the electrode wire being located within the receiving cavity; The substrate has an outlet hole, and the other end of the electrode wire passes through the outlet hole after leaving the coiled part, exits the receiving cavity, and extends toward the implantation site.

3. The integrated pulse generator according to claim 2, characterized in that, The substrate has a guide groove, and the other end of the electrode wire passes through the guide groove after leaving the coiled part, and then passes through the lead-out hole to exit the receiving cavity.

4. The integrated pulse generator according to claim 2 or 3, characterized in that, The outlet hole is opened along the axial direction of the coiled part.

5. The integrated pulse generator according to claim 3, characterized in that, The substrate has a base that abuts against the coiled part, and the guide groove is formed on the side of the base that abuts against the coiled part; the lead-out hole is formed on the base and communicates with the guide groove.

6. The integrated pulse generator according to claim 2 or 3, characterized in that, The integrated pulse generator also includes a guide post, which is disposed in the accommodating cavity; the other end of the electrode wire leaves the coil and is wound around the guide post to change its extension direction, and then passes through the lead-out hole to exit the accommodating cavity.

7. The integrated pulse generator according to claim 2, characterized in that, The integrated pulse generator also includes a locking device connected to the base and used to lock the rotation of the coiled component relative to the base.

8. The integrated pulse generator according to claim 7, characterized in that, The coiled component has circumferentially arranged ratchet teeth, and the locking device includes an engaging member adapted to the ratchet teeth, the engaging member being used to engage with the ratchet teeth to lock the rotation of the coiled component in the direction of releasing the electrode wire.

9. The integrated pulse generator according to claim 8, characterized in that, The locking device further includes a potential energy section for applying a potential force to the engaging member so that the engaging member engages with the ratchet when not subjected to external force.

10. The integrated pulse generator according to claim 2, characterized in that, The portion of the coiled component extending out of the accommodating cavity has anti-slip features, including anti-slip grooves, anti-slip protrusions, anti-slip patterns, or is made of anti-slip materials.

11. The integrated pulse generator according to claim 1, characterized in that, The integrated pulse generator is used for a temporary cardiac pacemaker, and the diameter of the electrode leads is 0.15 mm to 2 mm.

12. The integrated pulse generator according to claim 1, characterized in that, The winding component has a circumferentially concave winding groove, which is used for winding the electrode wire and for limiting the electrode wire.

13. The integrated pulse generator according to claim 12, characterized in that, The coiling groove is a spiral groove corresponding to the electrode wire, and its width corresponds to the outer diameter of the electrode wire.

14. The integrated pulse generator according to claim 1, characterized in that, The connecting hole can be a straight hole, an arc-shaped hole, or an oblique hole.

15. The integrated pulse generator according to claim 3, characterized in that, The guide groove is opened in a direction perpendicular to the axis of the coiled part.

Citation Information

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