WO2023273571A1

WO2023273571A1 - Pacing system and fixing device thereof

Info

Publication number: WO2023273571A1
Application number: PCT/CN2022/089216
Authority: WO
Inventors: 吴楠; 潘景昊
Original assignee: 创领心律管理医疗器械（上海）有限公司
Priority date: 2021-06-28
Filing date: 2022-04-26
Publication date: 2023-01-05
Also published as: CN115591121A

Abstract

Provided are a pacing system (100,100') and a fixing device thereof. The fixing device comprises a fixing member (30,30') and an anti-rotation assembly (40,40'). The fixing member (30,30') has a penetrating end (30a,30a'). The anti-rotation assembly (40,40') comprises a fixed base (41,41') and a movable base (42,42'). The movable base (42,42') is circumferentially limited to the fixed base (41,41'). The anti-rotation assembly (40,40') has a first state and a second state. When the anti-rotation assembly (40,40') is in the first state, the fixed base (41,41') and the movable base (42,42') are located on the back side of an end surface (10a,10a') of an electrode base (10,10'). When the anti-rotation assembly (40,40') is in the second state, the movable base (42,42') protrudes relative to one side of the fixed base (41,41') facing the penetrating end (30a,30a').

Description

Pacing system and its fixing device

Cross References to Related Applications

This application claims the priority of the Chinese patent application with the application number 202110720487.0 and the title of the invention "pacing system and its fixing device" submitted to the China Patent Office on June 28, 2021, the entire contents of which are incorporated in this application by reference .

technical field

The present application relates to the technical field of pacemakers, in particular to a pacemaker system and its fixing device.

technical background

At present, the lead wires of pacing systems (such as leadless pacemakers) or mainstream pacing systems mainly have two fixing methods: passive wing fixation and active screw fixation. Active screw fixation has the advantages of a large range of optional fixation positions and stability and reliability, so it is more and more widely used. The active screw fixation can have an anti-reversal structure, thereby increasing the stability and reliability of the fixation.

However, in the actual surgical operation, it is often necessary to screw the active helical structure into the body so that the head-end electrodes are in close contact with the body before the electrical properties of the pacing system or lead wire can be checked through measurement technology, and the implantation position and contact can be confirmed. Whether the condition meets the electrical performance requirements, so it often needs to be unscrewed twice or even multiple times. At this time, the anti-reverse structure becomes an obstacle to the unscrewing operation, which increases the difficulty of the operation and increases the damage to the human body.

Contents of the invention

According to various exemplary embodiments of the present application, there are provided a fixation device and a pacemaker including the fixation device.

In one aspect, the present application provides a fixing device, which is arranged in a pacing system, and the pacing system includes an electrode base and a head electrode fixed on the electrode base, and the head electrode has a structure protruding from the electrode base. The terminal outside the end surface; the fixing device is used to fix with the body so that the end of the head electrode is in contact with the body, and the fixing device includes:

a fastener having a piercing end; and

The anti-rotation assembly includes a fixed seat and a movable seat, the fixed seat is connected to the fixed member, the movable seat is circumferentially limited to the fixed seat, the anti-rotation assembly has a first state and a second state, In the first state, both the fixed seat and the movable seat are located on the back side of the end surface of the electrode base, and in the second state, the movable seat faces One side of the piercing end protrudes.

In one of the embodiments, the anti-rotation assembly includes a shrinkable member and an elastic member, the shrinkable member is in contact with the front of the movable seat, and when the volume of the shrinkable member shrinks, the elastic member Drive the movable seat to move toward the piercing end relative to the fixed seat; or,

The anti-rotation assembly includes an expandable member and an elastic member, the expandable member is located on the back of the movable seat, and the elastic member is used to press the movable seat against the expandable member, when the expandable member When the volume of the expandable part expands, the expandable part pushes the movable part to overcome the elastic force of the elastic part and makes the movable seat move toward the piercing end relative to the fixed seat.

In one of the embodiments, the fixed seat includes a ring piece and a plurality of fixed blocks, and the fixed blocks are arranged at intervals around the outer side of the ring piece, and the movable seat includes a connecting piece and a plurality of movable blocks, so that The plurality of movable blocks are arranged at intervals around the outer side of the connecting sheet, the plurality of fixed blocks and the plurality of movable blocks are arranged alternately along the circumferential direction, and the connecting sheet is located on the side of the ring sheet facing away from the electrode base One side of the end face of the seat.

In one embodiment, a groove is opened on the movable block, and the groove runs through the end surface of the movable seat.

In one of the embodiments, the fixing member is helical, the groove is a U-shaped groove or a V-shaped groove, and the end face of the movable seat is inclined in a direction opposite to the direction of rotation of the fixing member. .

In one of the embodiments, the shrinkable member is sandwiched between the ring piece and the connecting piece, the movable seat is driven by the elastic member, and the connecting piece has a position close to the ring. Tablet mobile trends.

In one of the embodiments, the shrinkable member is a dissolvable member.

In one of the embodiments, the pacing system includes an insulating base, the insulating base includes a shaft sleeve and a rib surrounding the outer periphery of the shaft sleeve, the ring piece is sleeved on the shaft sleeve, And make the fixed block lean against the rib, the connecting piece is sleeved on the shaft sleeve, and is located between the ring piece and the rib, the connection between the connecting piece and the ring piece An accommodating space surrounding the circumference of the sleeve is formed between them, and the dissolvable part is located in the accommodating space.

In one of the embodiments, a liquid passage hole is opened on the fixed block, and the liquid passage hole is located on the side of the end face of the ring sheet facing away from the fixed seat. When the anti-rotation component is in the first state, the liquid hole communicates with the receiving space.

In one of the embodiments, the elastic member is a spring, and the two ends of the spring elastically abut against the connecting piece and the rib respectively.

In one of the embodiments, the side of the connecting piece facing away from the ring piece is provided with an annular blind groove, and when the movable seat is installed on the insulating base, the annular blind groove surrounds the shaft One end of the spring is accommodated and limited in the annular blind groove.

In one of the embodiments, when the anti-rotation assembly is in the first state, the connecting piece abuts against the rib, and the entire structure of the spring is accommodated in the annular blind groove.

In one of the embodiments, the expandable member is arranged on the side of the connecting piece facing away from the ring piece, the movable seat is driven by the elastic member, and the connecting piece has a The movement trend of the ring piece.

In one embodiment, there are multiple expandable elements, and at least two of the expandable elements use different deformable materials.

In one of the embodiments, the pacing system includes an insulating base, the insulating base includes a shaft sleeve and a rib surrounding the outer circumference of the shaft sleeve, and the connecting piece and the ring piece are sleeved in turn. On the shaft sleeve, the expandable member is sandwiched between the connecting piece and the rib.

In one of the embodiments, the side of the fixing seat away from its end surface abuts against the rib, and a receiving space surrounding the circumference of the shaft sleeve is formed between the connecting piece and the rib , the expandable member is located in the accommodation space.

In one of the embodiments, the expandable member is a liquid-absorbent deformable material, and the fixed block is provided with a liquid-through hole, and the liquid-through hole is located on the end surface of the ring sheet facing away from the fixed seat When the anti-rotation component is in the first state, the liquid hole communicates with the receiving space.

In one embodiment, the connecting piece is provided with a through groove, and the liquid hole communicates with the receiving space through the through groove.

In one of the embodiments, the expandable member is provided with a liquid suction hole, and the liquid suction hole communicates with the through groove.

In one of the embodiments, the through groove includes an annular portion, and when the movable base is installed on the insulating base, the annular portion of the through groove surrounds the outer circumference of the sleeve, and the elastic member is a spring , one end of the spring is accommodated in the annular portion of the through groove, and the other end abuts against the ring piece.

In one embodiment, when the anti-rotation component is in the second state, the connecting piece is against the ring piece, and the entire structure of the spring is accommodated in the ring portion of the through groove.

In one of the embodiments, when the anti-rotation component is in the second state, the connecting piece abuts against the ring piece and seals the liquid hole.

In one of the embodiments, the spring is located between the connecting piece and the ring piece.

In one of the embodiments, at least one of the connecting piece and the ring piece is provided with an annular groove, and the annular groove is used to accommodate the spring. When the anti-rotation component is in the second state, the The connecting piece is against the ring piece.

In one embodiment, when the anti-rotation assembly is in the second state, the end surface of the movable seat is flush with the end surface of the electrode base.

In another aspect, the present application provides a pacing system, including the above-mentioned fixing device.

The above-mentioned pacing system and its fixing device, the fixing device includes a screw fixing part and an anti-rotation assembly, wherein the screw fixing part has a piercing end, the anti-rotation assembly includes a fixing seat and a movable seat, and the fixing seat is connected with the screw fixing part, The movable seat is circumferentially limited to the fixed seat, and the anti-rotation component has a first state and a second state. When the anti-rotation component is in the first state, both the fixed seat and the movable seat are located on the back side of the end surface of the electrode base of the pacing system , so as not to hinder the unscrewing operation of the screw fastener, and to avoid scratching the body; when the anti-rotation component is in the second state, the movable seat protrudes from the side of the fixed seat facing the piercing end, so that the movable seat and the The body is in contact with each other to limit the inversion of the helical fixing part, so as to improve the stability of the connection between the fixing device and the body.

Description of drawings

In order to more clearly illustrate the technical solutions in the embodiments of the present application or the prior art, the following will briefly introduce the drawings that need to be used in the description of the embodiments or the prior art. Obviously, the accompanying drawings in the following description are only These are some embodiments of the present application. Those skilled in the art can also obtain the drawings of other embodiments according to these drawings without creative work.

Fig. 1 is a partial structural diagram of a pacing system in an embodiment, wherein the anti-rotation component is in a first state.

Fig. 2 is a partial structural diagram of a pacing system in an embodiment, wherein the anti-rotation component is in a second state.

FIG. 3 is an exploded schematic diagram of a partial structure of the pacing system of Embodiment 1. FIG.

Fig. 4 is a schematic cross-sectional structural view of the anti-rotation assembly of the fixing device of the pacing system in an embodiment, wherein the anti-rotation assembly is in a first state.

Fig. 5 is a structural schematic diagram of the anti-rotation component of the fixing device shown in Fig. 4 when it is in a second state.

Fig. 6 is an exploded schematic diagram of the drug suppository and the electrode base in the pacing system in another embodiment.

FIG. 7 is an exploded schematic diagram of a partial structure of the pacing system of Embodiment 2. FIG.

FIG. 8 is a schematic cross-sectional structural view of the anti-rotation assembly of the fixing device of the pacing system shown in FIG. 7 , wherein the anti-rotation assembly is in a first state.

Fig. 9 is a perspective view of the structure of the fixing device of the pacing system shown in Fig. 7, wherein the anti-rotation component of the fixing device is in a first state.

Fig. 10 is a schematic structural view of the anti-rotation component of the fixing device shown in Fig. 9 when it is in a second state.

detailed description

In order to make the above-mentioned purpose, features and advantages of the present application more obvious and understandable, the specific implementation manners of the present application will be described in detail below in conjunction with the accompanying drawings. In the following description, numerous specific details are set forth in order to provide a thorough understanding of the application. However, the present application can be implemented in many other ways different from those described here, and those skilled in the art can make similar improvements without departing from the connotation of the present application, so the present application is not limited by the specific embodiments disclosed below.

In the description of the present application, the terms "first" and "second" are used for descriptive purposes only, and cannot be understood as indicating or implying relative importance or implicitly specifying the quantity of indicated technical features. Thus, the features defined as "first" and "second" may explicitly or implicitly include at least one of these features. In the description of the present application, "plurality" means at least two, such as two, three, etc., unless otherwise specifically defined.

In this application, terms such as "installation", "connection", "connection" and "fixation" should be interpreted in a broad sense, for example, it can be a fixed connection or a detachable connection, unless otherwise clearly specified and limited. , or integrated; it may be mechanically connected or electrically connected; it may be directly connected or indirectly connected through an intermediary, and it may be the internal communication of two components or the interaction relationship between two components, unless otherwise specified limit. Those of ordinary skill in the art can understand the specific meanings of the above terms in this application according to specific situations.

Example 1

As shown in FIG. 1 and FIG. 2 , a pacing system 100 according to an embodiment of the present application includes an electrode base 10 , a head electrode 20 and a fixing device.

The head electrode 20 is fixedly connected to the electrode base 10 and has a terminal 20a protruding from the end surface 10a of the electrode base 10 . The fixing device is used to fix the pacing system 100 at the implanted position, so that the tip 20a of the head electrode 20 is in stable contact with the body, so that the pacing system 100 can exert its pacing function.

It should be particularly pointed out that the pacing system 100 in this application can be either a pacing system 100 in the mode of a capsular pulse generator superimposed with an electrode lead, or a leadless pacemaker. A leadless pacemaker is itself a self-contained generator and electrode system that is implanted directly into the right ventricle through the femoral vein without the need for a chest incision or subcutaneous pocket, thereby eliminating the multiple complications associated with the leads in conventional pacemakers. Complications, such as capsular bag infection, hematoma, lead displacement, or lead breakage. Also, it looks more aesthetically pleasing since there is no chest incision or visible pacemaker pocket.

The type of the pacing system 100 in the present application is not limited here, as long as the implantation position allows, the structure of the fixing device in the pacing system 100 of the present application can meet all the fixing requirements of the pacing system 100 .

As shown in FIGS. 1 and 2 , the fixing device includes a fixing piece 30 and an anti-rotation assembly 40 . One end of the fixing member 30 is connected with the anti-rotation component 40, and the other end forms a piercing end 30a. It should be noted that the fixing member 30 may be a radial anchor claw, or may be a helical shape. When the fixing member 30 is helical, when the pacing system 100 needs to be fixed on the human body, the piercing end 30a can be used to puncture the human body, and the fixing member 30 can be screwed into the human body through rotation. Finally, the pacing system 100 is fixed to the body by using the fixing member 30, so that the tip 20a of the head electrode 20 is in contact with the body.

In order to facilitate the understanding of the technical solution, the following description will be made by taking the spiral shape of the fixing member 30 as an example, but the structure of the fixing member 30 is not limited.

In practical applications, after the pacing system 100 is fixed so that the tip 20a of the head electrode 20 is in contact with the body, it is necessary to measure the electrical properties of the pacing system 100 to confirm whether the implantation position and contact conditions meet the electrical performance requirements. . When the electrical properties cannot meet the requirements, the fixing member 30 needs to be separated from the body to find a suitable fixing position again. This embodiment adopts such a helical fixing member 30, which greatly facilitates the screw-in and screw-out operations.

The function of the anti-rotation component 40 is to restrict the fixing member 30 from rotating out of the body by contacting with the body, so that the pacing system 100 is stably fixed on the body. In the pacing system 100 of the present application, the anti-rotation component 40 has a first state and a second state. As shown in FIG. 1 , the anti-rotation component 40 is in the first state. In this state, when the fixing device is fixed on the human body, the anti-rotation component 40 does not contact the human body, and thus does not interfere with the unscrewing operation. Therefore, in the pacing system 100 When the electrical performance does not meet the requirements, the fixed position can be adjusted flexibly. As shown in FIG. 2 , the anti-rotation assembly 40 is in the second state, and the anti-rotation assembly 40 is in contact with the human body to restrict the fixing member 30 from rotating out of the human body. That is to say, the anti-rotation assembly 40 can adjust the timing of limiting the rotation of the fixing member 30 out of the human body by switching from the first state to the second state, so that it can be used to effectively strengthen the pacing system in the second state. The fixed stability of 100, at the same time, it can be used in the first state to reduce the difficulty of unscrewing operation, and avoid scratching the human body.

As shown in FIG. 3 , the anti-rotation assembly 40 includes a fixed seat 41 and a movable seat 42 .

The fixing seat 41 is connected with the fixing member 30 . In some embodiments, the fixing seat 41 and the fixing member 30 are integrally formed. In other embodiments, the fixing member 30 is welded and fixed to the fixing base 41 .

The movable seat 42 is circumferentially limited to the fixed seat 41 , that is, in the direction around the centerline of the fixed member 30 , and the movable seat 42 and the fixed seat 41 cannot rotate relative to each other. When the anti-rotation assembly 40 rotates around the centerline of the fixing member 30, the fixing member 30 rotates together with the movable seat 42 and the fixing seat 41, and finally the fixing member 30 is screwed into or out of the human body. In this embodiment, the movable seat 42 can move relative to the fixed seat 41 toward the side where the piercing end 30a is located, so that the anti-rotation assembly can 40 has a first state and a second state.

As shown in FIG. 4 , when the anti-rotation assembly 40 is in the first state, both the movable seat 42 and the fixed seat 41 are located on the back side of the end face 10a of the electrode base 10, and the back side refers to the side of the end face 10a away from the end head 20a . That is to say, neither the movable seat 42 nor the fixed seat 41 protrudes from the plane where the end surface 10 a of the electrode base 10 is located. In this way, when the fixing member 30 fixes the pacing system 100 to the body, even if the end surface 10a of the electrode base 10 is in contact with the body to ensure that the end 20a of the head electrode 20 is in effective contact with the body, the movable seat 42 and the fixed seat 41 will not contact with the body. Then, when the anti-rotation component 40 is in the first state, the anti-rotation component 40 will not be in contact with the human body, so that when the fixing part 30 is unscrewed out of the human body, the anti-rotation component 40 will not increase the difficulty of the unscrewing operation of the fixing part 30, and avoid scratches body. Neither the movable seat 42 nor the fixed seat 41 protrudes from the plane where the end face 10a of the electrode base 10 is located, including the case of being flush with the end face 10a, and also including the case of being far away from the end face 10a. The sides of the movable seat 42 and the fixed seat 41 close to the end 20a may be flush with each other, or may not be flush with each other, as long as they do not protrude from the plane where the end surface 10a of the electrode base 10 is located. In one embodiment, the sides of the movable seat 42 and the fixed seat 41 close to the end 20a are flush with each other, so that the structure of the instrument is more compact and firm, and the appearance is smooth and easy to operate.

As shown in FIG. 5 , when the anti-rotation assembly 40 is in the second state, the movable seat 42 protrudes from the side of the fixed seat 41 facing the piercing end 30a, and is used to contact the human body, so that the movable seat 42 and the human body can be used to contact each other. The contact restricts the reverse rotation of the fixing part 30 to prevent the fixing part 30 from rotating out of the human body.

It should be noted that the movable seat 42 protrudes relative to the fixed seat 41, which means that the end face 42a of the movable seat 42 protrudes toward the plane where the end face 10a of the electrode base 10 is located relative to the end face 41a of the fixed seat 41, so that the movable seat 42 can be in contact with the human body. The contact improves the anti-rotation performance of the pacing system 100 relative to the human body, and then restricts the fixing member 30 from rotating out of the human body.

As shown in Figure 3, the fixed seat 41 includes a ring piece 411 and a plurality of fixed blocks 412, and a plurality of fixed blocks 412 are arranged at intervals around the outer side of the ring piece 411; the movable seat 42 includes a connecting piece 421 and a plurality of movable blocks 422, a plurality of The movable blocks 422 are arranged at intervals around the outer side of the connecting piece 421 . A plurality of movable blocks 422 and a plurality of fixed blocks 412 are arranged alternately along the circumferential direction, and the connecting piece 421 is located on a side of the ring piece 411 facing away from the end surface 10 a of the electrode base 10 .

In some embodiments, a plurality of movable blocks 422 and a plurality of fixed blocks 412 are alternately fitted together to form a ring structure, and the ring structure is arranged around the circumference of the electrode base 10 . In the second state, the plurality of movable blocks 422 protrude relative to the plurality of fixed blocks 412, so that the anti-rotation assembly 40 has convex and concave characteristics, so as to form a stable grasping effect on the human body, thereby preventing the fixing member 30 from spinning out from the human body, so as to Stabilize and fix the pacing system 100 .

It should be noted that, the annular structure formed by fitting the plurality of movable blocks 422 and the plurality of fixed blocks 412 may be a standard ring structure, that is, the cross section is circular. In other embodiments, the ring structure may not be a standard ring structure, for example, a ring structure with a square or oval cross section. To be precise, as long as the plurality of movable blocks 422 and the plurality of fixed blocks 412 are engaged with each other so that the movable seat 42 is limited to the fixed seat 41 in the axial direction and can move relative to the fixed seat 41 in the axial direction, the anti-rotation assembly 40 can be changed from the first state Just switch to the second state.

Referring to Fig. 1 and Fig. 2 again, in some embodiments, the movable block 422 is provided with a groove 42b, and the groove 42b runs through the end surface 42a of the movable seat 42 (through the thickness direction of the movable block 422), so that when the anti-rotation The assembly 40 is in the second state, so that when the end surface 42a of the movable seat 42 is in contact with the body, the groove 42b can be embedded by part of the body tissue, thereby increasing the anchoring force and better restricting the fixing member 30 from rotating out of the body.

Further, the groove 42 b is a U-shaped groove or a V-shaped groove, and is inclined in a direction opposite to the direction of rotation of the fixing member 30 relative to the end surface 42 a of the movable seat 42 . Wherein, the rotation direction of the fixing member 30 refers to the rotation direction of the fixing member 30 screwed into the human body. In this embodiment, the inclined U-shaped groove or V-shaped groove is used to provide greater blocking force to prevent the fixing member 30 from rotating out of the human body, thereby improving the stability of the connection between the pacing system 100 and the human body.

In some embodiments, when the anti-rotation assembly 40 is in the second state, as shown in FIG. 5 , the end surface 42 a of the movable seat 42 is flush with the end surface 10 a of the electrode base 10 .

It should be noted here that "flush" not only includes the situation that the end surface 42a of the movable seat 42 and the end surface 10a of the electrode base 10 are on the same plane, but also includes the existence of the end surface 42a of the movable seat 42 and the end surface 10a of the electrode base 10. In the case of almost negligible height difference, as there is a height difference between the end surface 42a of the movable seat 42 and the end surface 10a of the electrode base 10 less than or equal to 3mm, as long as the anti-rotation assembly 40 is in the second state, the end surface of the movable seat 42 42a is in contact with the human body, and it is enough to increase the torque of the fixing member 30 reversely unscrewed from the human body, so that the movable seat 42 can play a better anti-rotation effect. Wherein, the reverse rotation of the fixing member 30 from the human body means that the fixing member 30 is screwed out of the human body in a direction opposite to the direction in which the fixing member 30 is screwed into the human body.

As shown in FIG. 3 to FIG. 5 , the anti-rotation assembly 40 includes a dissolvable part 43 and a spring 44 .

The dissolvable part 43 is arranged between the fixed seat 41 and the movable seat 42 . Specifically, the dissolvable part 43 is sandwiched between the ring piece 411 of the fixed seat 41 and the connecting piece 421 of the movable seat 42 . One end of the spring 44 is fixed relative to the movable seat 42 (referring to a fixed relative position), for example, the spring 44 is fixedly connected with the movable seat 42, or the spring 44 abuts against the connecting piece 421 of the movable seat 42, so that one end of the spring 44 is relatively Movable seat 42 is fixed. The other end of the spring 44 is fixed relative to the fixed seat 41 (referring to a fixed relative position), that is, the other end of the spring 44 and the fixed seat 41 are fixed to each other. For example, in some embodiments, the front of the movable seat 42 is connected to the fixed seat 41 through the dissolvable part 43, and the back is connected to the fixed seat 41 through the spring 44, and the spring 44 is in a compressed state, wherein the front refers to the side near the end face 10a , the back side refers to the side away from the end face 10a. In some other embodiments, the dissolvable part 43 is in contact with the front of the movable seat 42, and the movable seat 42 is kept against the dissolvable part 43 under the drive of the spring 44. As the volume of the dissolvable part 43 shrinks, the spring 44 drives The movable seat 42 moves toward the piercing end relative to the fixed seat 41, and finally the anti-rotation assembly 40 is switched to the second state.

In this embodiment, the spring 44 provides elastic force for the movable seat 42 , driven by the spring 44 , the connecting piece 421 has a tendency to move close to the ring piece 411 . Under the elastic force of the spring 44, the connecting piece 421 and the ring piece 411 clamp the dissolvable part 43, so that as the dissolving part 43 dissolves, the connecting piece 421 gradually approaches the ring piece 411, and then the movable seat 42 moves toward the fixed seat 41. The anti-rotation component 40 enters the second state finally by moving along the side close to the end surface 10a of the electrode base 10 .

In addition to the dissolvable part 43, a compressible part whose volume can be reduced in the body can also be used, and the dissolvable part 43 and the compressible part are collectively referred to as a shrinkable part. The spring 44 can also be replaced by other elastic members, such as rubber, thermoplastic elastomer and the like. The elastic member only needs to provide the movable seat 42 with a force to move to the front. For example, the front of the movable seat 42 may be connected to the fixed seat 41 through the stretched elastic member.

It should be pointed out that the dissolvable part 43 can be dissolved in a specific period of time or in a certain environment. In this way, with the dissolution of the dissolvable part 43, the movable seat 42 is driven by the spring 44, and the connecting piece 421 gradually approaches the ring piece. 411 , so that the plurality of movable blocks 422 connected to the connecting piece 421 will move relative to the plurality of fixed blocks 412 on the ring piece 411 . As shown in FIG. 4 and FIG. 5, after the dissolvable part 43 is completely dissolved, the movable block 422 protrudes from the end surface 41a of the fixed seat 41, so that the anti-rotation assembly 40 is in the second state, and the contact between the movable block 422 and the human body is used to Limit the fixing part 30 to unscrew out of the human body.

The dissolvable part 43 can be made of solid medicine that dissolves in the blood, such as solid substances such as steroid anti-inflammatory medicine and capsule sugar coating. In this way, even if the dissolvable part 43 is dissolved in the blood, no side effects will be produced. Moreover, after the dissolvable part 43 made of this type of solid drug is dissolved in the blood, it can also exert the beneficial effect of the corresponding medicine, just as the steroid anti-inflammatory drug After dissolving in the blood, the dissolvable part 43 can exert a good anti-inflammation effect, so as to eliminate the possible inflammation at the position where the fixing part 30 punctures the human body, thereby facilitating the recovery of the wound.

In other embodiments, the dissolvable part 43 can also be made of other non-drug materials. More suitably, the dissolvable part 43 is made of a material that is harmless to the human body and can be dissolved in blood within a certain period of time. The material of the dissolvable part 43 will not be repeated here.

The time required for the dissolvable part 43 to completely dissolve is related to the material, size and environment of the dissolvable part 43 . For example, in some embodiments, the disc-shaped dissolvable part 43 with a thickness of 2 mm and a diameter of 5 mm supported by steroid anti-inflammatory drugs is used. It takes 60 minutes to dissolve, which means that it takes 60 minutes for the anti-rotation component 40 adopting the dissolvable part 43 to change from the first state to the second state.

It should be noted that in practical applications, the material and size of the dissolvable part 43 can be reasonably configured according to actual needs, so as to adjust the time for complete dissolution, so as to achieve the purpose of controlling the anti-rotation component 40 to enter the second state and play its role. The purpose of the duration of anti-reverse performance.

As shown in FIG. 4 and FIG. 5 , during the dissolving process of the dissolvable part 43 , under the elastic force of the spring 44 the movable seat 42 moves relative to the fixed seat 41 and finally when the dissolvable part 43 is completely dissolved, the anti-rotation assembly 40 is in the The second state has the effect of restricting the fixing member 30 from rotating out of the human body. In this way, during the period of dissolution of the dissolvable part 43, that is, the period of time during which the anti-rotation component 40 changes from the first state to the second state, the timing for the anti-rotation component 40 to play an anti-reverse function is effectively delayed, that is, After a certain period of time after the pacing system 100 is implanted in the body, the anti-rotation component 40 enters the second state with the dissolution of the dissolvable part 43 .

Therefore, after the pacing system 100 with the anti-rotation component 40 is implanted in the body, even if the implantation position is not ideal or the electrical performance does not meet the requirements, the delay effect of the anti-rotation component 40 will give enough time to complete. The operation of screwing out and then screwing in again prevents the anti-reversal structure from contacting the human body during repeated operations, so as to reduce the difficulty of operation and reduce the damage to the human body.

In the embodiment in which the dissolvable member 43 is dissolved in the blood so that the anti-rotation assembly 40 gradually enters the second state, when the pacing system 100 is implanted in a suitable position and meets the electrical performance requirements, no subsequent operations are required. The component 43 dissolves in the blood, and the anti-rotation assembly 40 can automatically enter the second state to ensure the stability of the pacing system 100, which greatly improves the convenience and safety of the pacing system 100 in operation.

In some embodiments, the thickness d of the dissolvable part 43 ranges from 1mm to 5mm, such as 1mm, 2mm, 3mm, 4mm or 5mm. It should be noted that the thickness d of the dissolvable part 43 refers to the thickness of the dissolvable part 43 when it is not dissolved, that is, the initial thickness when it is sandwiched between the connecting piece 421 and the ring piece 411, that is, the anti-rotation component 40 In the first state, the distance between the connecting piece 421 and the ring piece 411 is also d. In this way, when the anti-rotation assembly 40 is in the second state, since the dissolvable part 43 is completely dissolved, the connecting piece 421 is in contact with the ring piece 411 , and then the connecting piece 421 moves relative to the ring piece 411 by a distance d. In this embodiment, the value range of the thickness d of the dissolvable part 43 is 1 mm to 5 mm, which can effectively control the distance that the connecting piece 421 moves relative to the ring piece 411. At this time, the movable block 422 connected to the connecting piece 421 moves The distance can be adapted to the functional requirements of the anti-rotation assembly 40 in the first state and the second state. To be precise, in the first state of the anti-rotation assembly 40, the movable block 422 is located on the back side of the end surface 10a of the electrode base 10 , will not increase the operation difficulty of the fixing member 30 to unscrew the human body; in the second state of the anti-rotation assembly 40, the movable block 422 moves a distance of d relative to the fixed seat 41, and finally the movable block 422 can be in contact with the human body, thereby limiting The fixing part 30 is unscrewed out of the human body to improve the fixing stability of the fixing device and the human body.

As shown in FIG. 3 and FIG. 4 , the pacing system 100 includes an insulating base 50 , and the insulating base 50 includes a sleeve 51 and a rib 52 surrounding the sleeve 51 . The electrode base 10 is passed through the shaft sleeve 51, and the ring piece 411 and the connecting piece 421 are both sleeved on the outside of the shaft sleeve 51, and the shaft sleeve 51 is used to realize radial positioning of the fixed seat 41 and the movable seat 42, so that the movable seat 42 and the movable seat 42 The fixed seat 41 is radially limited by the shaft sleeve 51, and since the movable seat 42 is circumferentially limited by the fixed seat 41, the movable seat 42 can only move axially relative to the fixed seat 41, and the anti-rotation assembly 40 is changed from the first state to the second state. Two-state stability.

It should be pointed out that, as shown in FIG. 4, the ring piece 411 has an inner hole 411a, and the diameter of the inner hole 411a is equal to the outer diameter of the shaft sleeve 51. After the fixing seat 41 is assembled on the insulating base 50, the shaft sleeve 51 Cooperate with the inner hole 411a of the ring piece 411 . Correspondingly, the connecting piece 421 is also provided with a shaft hole 421a, so that the connecting piece 421 is sleeved on the outside of the shaft sleeve 51 by using the shaft hole 421a. The sleeve 51 is sleeved on the head electrode 20 to install and fix the head electrode 20 .

In some embodiments, after the fixing base 41 is assembled on the insulating base 50 , the fixing block 412 of the fixing base 41 abuts against the rib 52 , so that the fixing base 41 is fixed relative to the insulating base 50 . In this embodiment, when the fixed block 412 of the fixed seat 41 abuts against the rib 52, the ring piece 411 is spaced from the rib 52, and the connecting piece 421 is located between the ring piece 411 and the rib 52, which can be dissolved The piece 43 is clamped between the connecting piece 421 and the ring piece 411 . Since the ring piece 411 and the connecting piece 421 are sleeved on the outside of the sleeve 51 , a receiving space around the circumference of the sleeve 51 is formed between the ring piece 411 and the connecting piece 421 , so that the dissolvable element 43 is disposed in the receiving space.

Further, the fixed block 412 is provided with a liquid hole 41b, which is located on the side of the ring piece 411 facing away from the end surface 41a of the fixed seat 41. When the anti-rotation assembly 40 is in the first state, the liquid hole 41b 41b communicates with the storage space, so that after the pacing system 100 is implanted in the body, the blood can enter the storage space where the dissolvable part 43 is located through the liquid hole 41b, so that the dissolvable part 43 can dissolve in the blood and avoid entering the storage space There is less blood in the body, which will easily lead to a slow dissolution efficiency of the soluble joint, which makes the waiting time for the anti-rotation component 40 to enter the second state to play the anti-reverse function to be longer.

It should be noted that the arrangement of the spring 44 has many possibilities, as long as the elastic force provided by the spring 44 can make the movable seat 42 have a tendency to move toward the side where the end surface 10a of the electrode base 10 is located relative to the fixed seat 41, it can be During the dissolving process of the dissolvable part 43 , the spring 44 drives the movable seat 42 toward the side where the end surface 10a of the electrode base 10 is located, and finally the anti-rotation assembly 40 enters the second state.

For example, in some embodiments, the side of the connecting piece 421 facing away from the ring piece 411 is provided with an annular blind groove 42c. When the movable seat 42 is installed on the insulating base 50, the annular blind groove 42c surrounds the outer circumference of the shaft sleeve 51, One end of the spring 44 is accommodated and limited in the annular blind groove 42c. When the movable seat 42 and the fixed seat 41 are assembled to the insulating base 50, the other end of the spring 44 abuts against the rib 52 and is fixed relative to the fixed seat 41. In this embodiment, as the dissolvable part 43 between the connecting piece 421 and the ring piece 411 dissolves, the elastic force of the spring 44 can drive the connecting piece 421 close to the ring piece 411 .

The annular blind groove 42c on the connecting piece 421 can improve the installation stability of the spring 44, and at the same time, can accommodate at least part of the structure of the spring 44. For example, as shown in FIG. 4, when the anti-rotation assembly 40 is in the first state, the connecting piece 421 abuts against the rib 52 of the insulating base 50, and the entire structure of the spring 44 is accommodated in the annular blind groove 42c. Utilizing this structural arrangement, the overall structure of the fixing device is small and exquisite, the overall volume is reduced, and it is beneficial to play a fixing role in the body for a long time.

In some other embodiments, no annular blind groove 42c is provided on the connecting piece 421 , and the two ends of the spring 44 elastically abut against the connecting piece 421 and the rib 52 of the insulating base 50 respectively. There are other situations regarding the arrangement of the spring 44 in the fixing device, which will not be repeated here.

As shown in FIG. 3 , in an embodiment where the pacing system 100 includes an insulating base 50 , the pacing system 100 includes a connecting member 60 , a sealing member 70 and a feedthrough 80 .

Wherein, the connecting piece 60 is connected to a side of the insulating base 50 facing away from the anti-rotation assembly 40 , and the fixing device can be assembled to the pacing system 100 by using the connecting piece 60 . For example, when the pacing system 100 is a leadless pacemaker, the connector 60 is connected to the packaging case (not shown) of the leadless pacemaker, and the packaging case of the leadless pacemaker can be made of titanium metal. . For another example, the side of the connector 60 away from the insulating base 50 is connected to the main body of the electrode lead (not shown).

The sealing member 70 is used to install the main body of the feedthrough 80 and is connected with the connecting member 60 . A good liquid sealing effect can be achieved by using the sealing member 70, so that the sealing member 70, the connecting member 60, the feedthrough 80 and the package housing form a completely sealed space; wherein, the main body of the feedthrough 80 is installed on the sealing member 70, and the feedthrough 80 One end of the guide wire 801 passing through 80 passes through the sealed channel and is electrically connected to the head electrode 20 installed on the electrode base 10 , and the other end of the guide wire 801 feeding through 80 is electrically connected to the electrical components of the pacing system 100 , For example, the other end of the guide wire 801 of the feedthrough 80 is electrically connected to the electrical components of the leadless pacemaker or the guide wire inside the electrode lead.

As shown in FIG. 6 , the end of the electrode base 10 close to its end surface 10 a is sheathed with a drug plug 90 , so that after the fixing device of the pacing system 100 is fixed on the body, the drug plug 90 can be used to carry corresponding drugs to improve the curative effect. As shown in FIG. 1 , the drug plug 90 is sheathed on the outside of the electrode base 10, and the end face 90a of the drug plug 90 is basically flush with the end face 10a of the electrode base 10, so that after the fixing device of the pacing system 100 is fixed on the human body, , the end surface 90a of the medicine suppository 90 is in contact with the human body to exert the corresponding medicine effect.

In the above-mentioned embodiment, the shape change occurs through the dissolution of the dissolvable part 43, so that the anti-rotation assembly 40 gradually enters the second state from the first state. The turn effect has a certain delay effect.

In other embodiments, other body-shape changeable members can also be arranged between the fixed seat 41 and the movable seat 42 to adaptively delay the timing of the anti-rotation assembly 40 entering the second state. For example, as shown in FIG. 7 , in Embodiment 2 provided by the present application, the anti-rotation assembly 40 is provided with an expandable member 43 ′, and the expansion member 43 ′ is deformed within a certain period of time or under certain conditions to realize the anti-rotation assembly 40 . Change from the first state to the second state.

Example 2

As shown in FIG. 7 and FIG. 8 , the structure of the pacing system 100 ′ of the second embodiment is basically the same as that of the pacing system 100 of the first embodiment. The pacing system 100' of the second embodiment includes an electrode base 10', a head electrode 20' and a fixing device.

The head electrode 20' is fixedly connected to the electrode base 10', and has a terminal 20a' protruding from the end surface 10a' of the electrode base 10'. The fixing device is used to fix the pacing system 100' at the implanted position, so that the tip 20a' of the head electrode 20' is in stable contact with the body, so that the pacing system 100' can exert its pacing function.

The fixing device includes a fixing piece 30' and an anti-rotation component 40'. One end of the fixing member 30' is connected with the anti-rotation component 40', and the other end forms a piercing end 30a'.

The anti-rotation assembly 40' has a first state and a second state. As shown in Figure 9, the anti-rotation assembly 40' is in the first state. In this state, when the fixing device is fixed on the body, the anti-rotation assembly 40' does not contact the body, and thus does not interfere with the unscrewing operation. When the electrical performance of the system 100' does not meet the requirements, the fixed position can be flexibly adjusted. As shown in FIG. 10 , the anti-rotation component 40 ′ is in the second state, the anti-rotation component 40 ′ is in contact with the human body, and restricts the fixing member 30 ′ from rotating out of the human body. That is to say, the anti-rotation component 40' can adjust the timing of restricting the fixing part 30' from rotating out of the human body by switching from the first state to the second state, so that it can effectively strengthen the anti-rotation component 40' in the second state. The fixed stability of the stroke system 100' can be used, and at the same time, it can be used in the first state to reduce the difficulty of unscrewing operation and avoid scratching the human body.

The anti-rotation assembly 40' includes a fixed seat 41', a movable seat 42', an expandable part 43' and a spring 44'. The difference between the pacing system 100' of Embodiment 2 and the pacing system 100' of Embodiment 1 is that in the pacing system 100' of Embodiment 2, the anti-rotation component 40' is provided with an inflatable member 43', instead of the Dissolvable part 43 in 1. Utilizing the volume change of the expandable member 43', the movable seat 42' gradually moves relative to the fixed seat 41', so that the process of changing the anti-rotation assembly 40' from the first state to the second state has the effect of delaying the anti-reverse function. Effect. In some embodiments, the spring 44 can also be replaced by other elastic members, such as rubber, thermoplastic elastomer and the like. In short, the elastic member is used to offset the movable seat 42' and the expandable member 43'. When the volume of the expandable member 43' expands, the expandable member 43' pushes the movable seat 42' to overcome the elastic force of the elastic member to make the movable seat 42' moves toward the piercing end 30a' relative to the fixed seat 41'.

It should be noted that there are many possibilities for the location of the elastic member. For example, in some embodiments, the front of the movable seat 42' is connected to the fixed seat 41' through the elastic member in a compressed state, and the back is connected to the fixed seat 41' through the expandable member 43'. The fixing seat 41' is connected, wherein the front side refers to the side close to the end face 10a', and the back side refers to the side away from the end face 10a'. It is also possible that the back side of the movable seat 42' is connected with the fixed seat 41' through an elastic member in a stretched state, and the elastic member only needs to provide the movable seat 42 with a force to move to the front. The structures of the fixed seat 41' and the movable seat 42' in the second embodiment are similar to those in the first embodiment.

As shown in FIG. 7 , the fixing base 41 ′ includes a ring piece 411 ′ and a plurality of fixing blocks 412 ′, and the fixing blocks 412 ′ are arranged at intervals around the outer side of the ring piece 411 ′. The movable seat 42' includes a connecting piece 421' and a plurality of movable blocks 422', and the plurality of movable pieces 422' are arranged at intervals around the outer side of the connecting piece 421'.

As shown in FIG. 8 to FIG. 10, a plurality of fixed blocks 412' and a plurality of movable blocks 422' are arranged alternately along the circumferential direction, for example, the two are alternately fitted together, and the connecting piece 421' is located on the back of the ring piece 411'. To the side of the end surface 10a' of the electrode base 10'.

As shown in FIG. 8 and FIG. 9 , when the anti-rotation assembly 40 ′ is in the first state, the movable seat 42 ′ and the fixed seat 41 ′ are located on the back side of the end surface 10 a ′ of the electrode base 10 ′.

As shown in FIG. 10 , when the anti-rotation assembly 40' is in the second state, the movable seat 42' protrudes relative to the fixed seat 41' and is used to contact the human body, so that the contact between the movable seat 42' and the human body is used to limit the fixed member. 30' is reversed to prevent the fixing part 30' from rotating out of the body.

In some embodiments, the movable block 422' is provided with a groove 42b', and the groove 42b' runs through the end surface 42a' of the movable seat 42', so that when the anti-rotation assembly 40' is in the second state, the movable seat 42' When the end face 42a' is in contact with the body, the groove 42b' can be embedded by part of the body tissue, thereby increasing the anchoring force and better restricting the fixing member 30' from rotating out of the body.

Further, the groove 42b' is a U-shaped groove or a V-shaped groove, and is inclined in a direction opposite to the direction of rotation of the fixing member 30' relative to the end surface 42a' of the movable seat 42'. Wherein, the rotation direction of the fixing part 30' refers to the rotation direction of the fixing part 30' being screwed into the human body. In this embodiment, the inclined U-shaped groove or V-shaped groove is used to provide greater blocking force to prevent the fixing member 30 ′ from rotating out of the human body, thereby improving the stability of the connection between the pacing system 100 ′ and the human body.

The expandable part 43' is disposed on the side of the connecting piece 421' facing away from the ring piece 411', and the expandable part 43' is a temperature-sensitive deformable material, a photo-induced deformable material or a liquid-absorbent deformable material. The spring 44' is elastically arranged between the movable seat 42' and the fixed seat 41', and keeps the connecting piece 421' in contact with the expandable part 43'. When the expandable part 43' expands, the expandable part 43' drives the connection The piece 421' is close to the ring piece 411', so that the anti-rotation assembly 40' moves from the first state to the second state.

In this embodiment, when the inflatable part 43' is not inflated, the anti-rotation assembly 40' is in the first state. With the expansion of the inflatable part 43', the connecting piece 421' approaches the ring piece 411', and then connects with the connecting piece 421. The connected movable block 422' moves toward the side of the end surface 10a' of the electrode base 10' relative to the fixed block 412' of the fixed seat 41', finally making the anti-rotation assembly 40' switch from the first state to the second state.

It should be noted that there may be multiple expandable components 43', and at least two of the multiple expandable components 43' adopt different deformable materials. Therefore, different means can be adopted to expand the corresponding expandable part 43', and then to precisely control the moving distance of the connecting piece 421' relative to the ring piece 411', so that the adjustment process of the anti-rotation component 40' is more precise, which is conducive to improving operational safety. sex.

The temperature-sensitive deformable material includes poly-N-isopropylacrylamide, and when the temperature of the temperature-sensitive deformable material is increased, an expansion effect can be obtained, and then the expandable member 43 made of the temperature-sensitive deformable material ’, it can adapt to drive the movable seat 42' to move relative to the fixed seat 41', so as to meet the requirement of moving the anti-rotation assembly 40' from the first state to the second state.

The photodeformable material includes cinnamic acid derivative polymers. When the electrical performance of the pacing system 100' is determined to be normal in the body, infrared light can be used to penetrate the skin at the corresponding position to make the photodeformable material expand. Therefore, this The expandable member 43' of material can drive the movable seat 42' to move relative to the fixed seat 41', so as to achieve the effect of moving the anti-rotation assembly 40' from the first state to the second state.

The liquid-absorbent deformable material includes sodium polyacrylate-based superabsorbent resin. In this way, when the expandable member 43' is made of a liquid-absorbent deformable material, the expandable member 43' can absorb the moisture in the blood and gradually expand, and then in the process of expansion, it will produce a force on the connecting piece 421' of the movable seat 42'. The extrusion force makes the movable seat 42' move relative to the fixed seat 41', so that the anti-rotation component 40' switches to the second state, so as to prevent the fixing part 30' from rotating out of the body and improve the connection stability between the fixing device and the body.

In the second embodiment, referring to FIG. 7 and FIG. 8 , the pacing system 100 ′ includes an insulating base 50 ′, and the insulating base 50 ′ includes a shaft sleeve 51 ′ and a rib 52 ′ surrounding the outer circumference of the shaft sleeve 51 ′. The connecting piece 421' and the ring piece 411' are sequentially sleeved on the shaft sleeve 51', and the expandable part 43' is sandwiched between the connecting piece 421' and the rib 52', so that when the expandable part 43' expands, the rib 52' restricts the expandable part 43', so that the expandable part 43' expands toward the side where the connecting piece 421' is located, and then drives the connecting piece 421' close to the ring piece 411', so that the movable block 422 on the connecting piece 421' 'then the fixed block 412' on the ring piece 411' moves toward the end surface 10a' of the electrode base 10', and finally the anti-rotation component 40' enters the second state, and the contact between the movable block 422' and the body prevents the fixed part 30 from ' Unscrew the body.

As shown in Figure 8, the side of the fixed seat 41' away from its end surface 41a' abuts against the rib 52', and there is a storage space around the circumference of the shaft sleeve 51' between the connecting piece 421' and the rib 52'. Space, the expandable member 43' is located in the receiving space, so that the overall structure of the anti-rotation assembly 40' is compact.

When the expandable member 43' is a liquid-absorbing deformable material, a liquid passage hole 41b' is opened on the fixed block 412', and the liquid passage hole 41b' is located at the end surface 41a' of the ring piece 411' facing away from the fixed seat 41'. On one side, when the anti-rotation component 40' is in the first state, the liquid hole 41b' communicates with the receiving space, so that when the pacing system 100' is implanted in the body, blood can enter the receiving space, thereby adapting to the expandable member 43 'Expansion deformation needs.

Continuing to refer to Fig. 8, the connecting piece 421' is provided with a through groove 42c', and the liquid passage hole 41b' communicates with the storage space through the through groove 42c'. , will not affect the overall volume of the anti-rotation assembly 40', and at the same time, can meet the needs of blood entering the receiving space and adapting to the expansion and deformation of the expandable member 43'.

Further, the expandable member 43' is provided with a liquid suction hole 43a', and the liquid suction hole 43a' communicates with the through groove 42c', so that the liquid suction hole 43a' can be used to improve the water absorption efficiency of the expandable member 43' to reasonably control The expansion speed of the expandable member 43'.

Continuing to refer to Fig. 8, the through groove 42c' includes an annular part. When the movable seat 42' is installed on the insulating base 50', the annular part of the through groove 42c' surrounds the outer circumference of the shaft sleeve 51', and one end of the spring 44' accommodates In the annular part of the through groove 42c', the other end is offset against the ring piece 411'. In this way, the through groove 42c' is used to provide installation space for the spring 44', which improves the compactness of the overall structure and makes the fixing device smaller as a whole, which is conducive to improving safety. performance.

Further, when the anti-rotation assembly 40' is in the second state, the connecting piece 421' abuts against the ring piece 411', and the entire structure of the spring 44' is accommodated in the annular part of the through groove 42c', so that the anti-rotation assembly 40 'In the second state, the spring 44' is accommodated in the annular part of the through groove 42c', and the overall mechanism of the anti-rotation assembly 40' is compact and takes up little space.

It should be noted that, in some embodiments, when the anti-rotation assembly 40' is in the second state, the connecting piece 421' abuts against the ring piece 411' and seals the fluid hole 41b', so that the fluid hole 41b 'closed to reduce blood continuing to enter the receiving space, so that the expandable member 43' can maintain a reasonable degree of expansion, reduce the extrusion force between the internal components of the anti-rotation assembly 40', and improve the overall structural stability.

Of course, in some embodiments, the material or size of the expandable member 43' can also be set so that when the expandable member 43' is fully expanded, the anti-rotation assembly 40' is in the second state, and the internal elements The extrusion force is controlled within a reasonable range. For example, in some practical ways, the initial thickness h of the expandable member 43' is 1mm, and after absorbing moisture and fully expanding, the thickness of the expandable member 43' is 3mm, that is to say, the expansion of the expandable member 43' drives The movable seat 42' has moved 2 mm relative to the fixed seat 41', so that when the anti-rotation is maintained in the second state, the pressing force of the expandable member 43' on the movable seat 42' is reduced as little as possible.

It should be noted that, in the above embodiment, the location of the spring 44' is not limited to the case where the expandable member 43' is a liquid-absorbent deformable material.

It doesn't matter what kind of deformable material the expandable member 43' is. The installation position of the spring 44' can be arranged between the connecting piece 421' and the ring piece 411', as long as the connecting piece 421' is held against the expandable part 43', so that the expansion deformation of the expandable part 43' The connecting piece 421 ′ can be driven gradually close to the ring piece 411 ′ to realize the movement of the anti-rotation component 40 ′ from the first state to the second state.

Further, at least one of the connecting piece 421' and the ring piece 411' is provided with an annular groove (similar to the structure of the annular part of the through groove 42c'), and the annular groove is used to accommodate the spring 44', when the anti-rotation assembly 40 'When in the second state, the connecting piece 421' abuts against the ring piece 411', so that the anti-rotation assembly 40' is kept in the second state, and the spring 44' can be effectively accommodated in the annular groove to facilitate anti-rotation Miniaturization of the overall structure of the turn assembly 40'.

As shown in FIG. 7 , the pacing system 100 ′ of the second embodiment is similar to that of the first embodiment, and the pacing system 100 ′ further includes a connecting part 60 ′, a sealing part 70 ′ and a feedthrough 80 ′.

Wherein, the connecting piece 60' is connected to the side of the insulating base 50' facing away from the anti-rotation assembly 40', and the fixing device can be assembled to the pacing system 100' by using the connecting piece 60'. For example, when the pacing system 100' is a leadless pacemaker, the connector 60' is connected to the leadless pacemaker's packaging case (not shown), and the leadless pacemaker's packaging case can be made of titanium. Made of metal. For another example, the side of the connecting member 60 ′ away from the insulating base 50 ′ is connected to the main body of the electrode lead.

The sealing member 70' is used to install the main body of the feedthrough 80' and is connected with the connecting member 60'. A good liquid sealing effect can be achieved by using the sealing member 70 ′, so that the sealing member 70 ′, the connecting member 60 ′, the feedthrough 80 ′ and the packaging shell form a completely sealed space. Wherein, the main body of the feedthrough 80' is installed on the sealing member 70', and one end of the guide wire 801' of the feedthrough 80' passes through the sealed channel and is electrically connected with the head electrode 20' installed on the electrode base 10'. The other end of the guide wire 801' through 80' is electrically connected to the electrical components of the pacing system 100', for example, the other end of the guide wire 801' fed through 80' is connected to the electrical components or electrode leads of a leadless pacemaker. The internal wire is electrically connected.

The end of the electrode base 10' close to its end surface 10a' is sheathed with a drug plug 90', so that after the fixing device of the pacing system 100' is fixed on the body, the drug plug 90' can carry corresponding drugs to improve the curative effect. As shown in FIG. 9 and FIG. 10, the drug plug 90' is sheathed on the outside of the electrode base 10', and the end face 90a' of the drug plug 90' is basically flush with the end face 10a' of the electrode base 10', so that the pacing After the fixing device of the system 100' is fixed on the human body, the end surface 90a' of the medicine suppository 90' contacts the human body to exert corresponding drug effects.

The technical features of the above embodiments can be combined arbitrarily. To make the description concise, all possible combinations of the technical features in the above embodiments are not described. However, as long as there is no contradiction in the combination of these technical features, they should be It is considered to be within the range described in this specification.

The above examples only express several implementation modes of the present application, and the description thereof is relatively specific and detailed, but should not be construed as limiting the scope of the patent application. It should be noted that those skilled in the art can make several modifications and improvements without departing from the concept of the present application, and these all belong to the protection scope of the present application. Therefore, the scope of protection of the patent application should be based on the appended claims.

Claims

A fixing device arranged in a pacing system, the pacing system includes an electrode base and a head electrode fixed on the electrode base, the head electrode has a terminal protruding from the end surface of the electrode base ; The fixing device is used to fix with the body so that the end of the head electrode is in contact with the body, and the fixing device includes:

a fastener having a piercing end; and

The anti-rotation assembly includes a fixed seat and a movable seat, the fixed seat is connected to the fixed member, and the movable seat is circumferentially limited to the fixed seat; the anti-rotation assembly has a first state and a second state, In the first state, both the fixed seat and the movable seat are located on the back side of the end surface of the electrode base, and in the second state, the movable seat faces One side of the piercing end protrudes.
The fixing device according to claim 1, wherein the anti-rotation assembly includes a shrinkable part and an elastic part, the shrinkable part is in contact with the front of the movable seat, and when the volume of the shrinkable part shrinks , the elastic member drives the movable seat to move toward the piercing end relative to the fixed seat; or,

The anti-rotation assembly includes an expandable member and an elastic member, the expandable member is located on the back of the movable seat, and the elastic member is used to press the movable seat against the expandable member, when the expandable member When the volume of the expandable part expands, the expandable part pushes the movable part to overcome the elastic force of the elastic part and makes the movable seat move toward the piercing end relative to the fixed seat.
The fixing device according to claim 2, wherein the fixed seat includes a ring piece and a plurality of fixed blocks, and the plurality of fixed blocks are arranged at intervals around the outer side of the ring piece, and the movable seat includes a connecting piece and a plurality of a plurality of movable blocks, the plurality of movable blocks are arranged at intervals around the outer side of the connecting piece, the plurality of fixed blocks and the plurality of movable blocks are arranged alternately along the circumferential direction, and the connecting piece is located on the back of the ring piece to the side of the end face of the electrode base.
The fixing device according to claim 3, wherein a groove is opened on the movable block, and the groove runs through the end surface of the movable seat.
The fixing device according to claim 4, wherein the fixing member is in a spiral shape, the groove is a U-shaped groove or a V-shaped groove, and the end face opposite to the movable seat faces the rotation of the fixing member. Tilt in the opposite direction.
The fixing device according to claim 3, wherein the shrinkable part is sandwiched between the ring piece and the connecting piece, the movable seat is driven by the elastic piece, and the connecting piece Has a tendency to move closer to the ring piece.
6. The fixation device of claim 6, wherein the shrinkable member is a dissolvable member.
The fixing device according to claim 7, wherein the pacing system includes an insulating base, the insulating base includes a shaft sleeve and a rib surrounding the outer circumference of the shaft sleeve, and the ring piece is sleeved on the the shaft sleeve, and make the fixed block abut against the rib, the connecting piece is sleeved on the shaft sleeve, and is located between the ring piece and the rib, the connecting piece and the rib An accommodating space around the periphery of the shaft sleeve is formed between the ring pieces, and the dissolvable part is located in the accommodating space.
The fixing device according to claim 8, wherein the fixing block is provided with a liquid passage hole, and the liquid passage hole is located on the side of the end face of the ring sheet facing away from the fixing seat, when the anti When the rotating assembly is in the first state, the liquid passage hole communicates with the receiving space.
The fixing device according to claim 8, wherein the elastic member is a spring, and the two ends of the spring elastically abut against the connecting piece and the rib respectively.
The fixing device according to claim 10, wherein an annular blind groove is opened on the side of the connecting piece facing away from the ring piece, and when the movable seat is installed on the insulating base, the annular blind groove The groove surrounds the outer circumference of the shaft sleeve, and one end of the spring is accommodated and limited in the annular blind groove.
The fixing device according to claim 11, wherein, when the anti-rotation assembly is in the first state, the connecting piece abuts against the rib, and the entire structure of the spring is accommodated in the annular blind groove.
The fixing device according to claim 3, wherein the expandable member is arranged on the side of the connecting piece facing away from the ring piece, the movable seat is driven by the elastic member, and the connecting piece The blades have a tendency to move away from the ring blades.
The fixing device according to claim 13, wherein there are a plurality of expandable elements, and at least two of the expandable elements adopt different deformable materials.
The fixing device according to claim 13, wherein the pacing system includes an insulating base, the insulating base includes a shaft sleeve and a rib surrounding the outer circumference of the shaft sleeve, the connecting piece and the The ring pieces are sequentially sleeved on the shaft sleeve, and the expandable part is sandwiched between the connecting piece and the rib.
The fixing device according to claim 15, wherein, the side of the fixing seat away from the end face thereof abuts against the rib, and a ring surrounding the sleeve is formed between the connecting piece and the rib. A surrounding storage space, the expandable member is located in the storage space.
The fixing device according to claim 16, wherein the expandable member is a liquid-absorbing deformable material, and the fixing block is provided with a liquid passage hole, and the liquid passage hole is located on the back side of the ring piece. One side of the end face of the fixing seat, when the anti-rotation component is in the first state, the liquid hole communicates with the receiving space.
The fixing device according to claim 17, wherein the connecting piece is provided with a through groove, and the liquid hole communicates with the receiving space through the through groove.
The fixing device according to claim 18, wherein the expandable member is provided with a liquid suction hole, and the liquid suction hole communicates with the through groove.
The fixing device according to claim 18, wherein the through groove includes an annular portion, and when the movable seat is mounted on the insulating base, the annular portion of the through groove surrounds the outer circumference of the sleeve, so that The elastic member is a spring, one end of the spring is accommodated in the annular portion of the through groove, and the other end is against the ring piece.
The fixing device according to claim 20, wherein when the anti-rotation assembly is in the second state, the connecting piece abuts against the ring piece, and the entire structure of the spring is accommodated in the ring portion of the through groove .
The fixing device according to claim 17, wherein when the anti-rotation component is in the second state, the connecting piece abuts against the ring piece and seals the liquid hole.
The fixing device according to claim 20, wherein the spring is located between the connecting piece and the ring piece.
The fixing device according to claim 23, wherein at least one of the connecting piece and the ring piece is provided with an annular groove, and the annular groove is used to accommodate the spring. When the anti-rotation component is in the second In a state, the connecting piece abuts against the ring piece.
The fixing device according to claim 1, wherein when the anti-rotation assembly is in the second state, the end surface of the movable seat is flush with the end surface of the electrode base.
A pacing system, comprising the fixation device according to any one of claims 1-25.