CN115591121A

CN115591121A - Pacing system and fixing device thereof

Info

Publication number: CN115591121A
Application number: CN202110720487.0A
Authority: CN
Inventors: 吴楠; 潘景浩
Original assignee: Microport Sorin CRM Shanghai Co Ltd
Current assignee: Microport Sorin CRM Shanghai Co Ltd
Priority date: 2021-06-28
Filing date: 2021-06-28
Publication date: 2023-01-13
Also published as: WO2023273571A1

Abstract

The invention relates to the technical field of pacemakers, and provides a pacing system and a fixing device thereof. According to the pacing system and the fixing device thereof, the anti-rotation component is in the first state and the second state, the screwing-out operation of the fixing piece and the requirement for improving the connection stability are respectively adapted, and the problems that the anti-rotation structure of the traditional pacemaker hinders the screwing-out operation, the operation difficulty is increased, and the injury to a human body is increased are effectively solved.

Description

Pacing system and fixing device thereof

Technical Field

The invention relates to the technical field of pacemakers, in particular to a pacing system and a fixing device thereof.

Background

At present, the electrode lead of a pacing system (such as a leadless pacemaker) or the pacing system which is mainstream at present mainly has two fixing modes of passive wing fixing and active spiral fixing, wherein the active spiral fixing mode has the advantages of large selectable range of fixing positions and stability and reliability, and therefore, the application is more and more extensive. For the active screw fixing mode, an anti-reversion structure can be provided, so that the stability and the reliability of the fixing are increased.

However, in the actual operation process, the active spiral structure is often required to be screwed into the body, so that after the head electrode is tightly contacted with the body, the electrical performance of the pacing system or the electrode lead can be checked through a measurement technology, and whether the implantation position and the contact condition meet the electrical performance requirements is confirmed, therefore, the active spiral structure is often required to be screwed out and screwed in for two or more times, and at the moment, the anti-reverse structure is a barrier to the screwing-out operation, the operation difficulty is increased, and the injury to the body is increased.

Disclosure of Invention

In view of this, it is necessary to provide a fixing device and a pacemaker including the same, aiming at the problems that the anti-inversion structure of the existing pacemaker prevents the unscrewing operation, increases the difficulty of the operation and increases the damage to the body.

In one aspect, the present invention provides a fixation device for a pacing system, the pacing system including an electrode base and a tip electrode fixed to the electrode base, the tip electrode having a tip extending beyond an end of the electrode base; the fixing device is used for fixing with the organism so that the tip of the head electrode contacts with the organism, and the fixing device comprises:

a fixing member having a piercing end; and

prevent changeing the subassembly, including fixing base and sliding seat, the fixing base with the mounting is connected, sliding seat circumference spacing in the fixing base, prevent changeing the subassembly and have first state and second state under the first state, the fixing base with the sliding seat all is located the dorsal part of electrode base's terminal surface under the second state, the sliding seat is relative the orientation of fixing base one side protrusion of thorn income end.

In one embodiment, the anti-rotation component comprises a reducible part and an elastic part, wherein the reducible part is contacted with the front face of the movable seat, and when the volume of the reducible part is reduced, the elastic part drives the movable seat to move towards the puncture end relative to the fixed seat; alternatively, the first and second liquid crystal display panels may be,

prevent changeing the subassembly and include expandable piece and elastic component, expandable piece is located the back of sliding seat, the elastic component be used for with the sliding seat with expandable piece offsets, works as when the volume expansion of expandable piece, expandable piece promotes the moving part overcomes the elastic force of elastic component makes the sliding seat is relative the fixed seat to pierce in the end and remove.

In one embodiment, the fixing seat comprises a ring piece and a plurality of fixing blocks, the fixing blocks are arranged around the outer side of the ring piece at intervals, the movable seat comprises a connecting piece and a plurality of movable blocks, the movable blocks are arranged around the outer side of the connecting piece at intervals, the fixing blocks and the movable blocks are alternately arranged along the circumferential direction, and the connecting piece is located on one side, back to the end face of the electrode base, of the ring piece.

In one embodiment, the movable block is provided with a groove, and the groove penetrates through the end face of the movable seat.

In one embodiment, the fixing element is spiral, the groove is a U-shaped groove or a V-shaped groove, and the groove is inclined in a direction opposite to the rotation direction of the fixing element relative to the end surface of the movable seat.

In one embodiment, the reducible part is clamped between the ring plate and the connecting plate, the movable seat is driven by the elastic part, and the connecting plate has a moving trend close to the ring plate.

In one embodiment, the reducible member is a dissolvable member.

In one embodiment, the pacing system comprises an insulating base, the insulating base comprises a shaft sleeve and a flange arranged on the periphery of the shaft sleeve in a surrounding mode, the ring piece is sleeved on the shaft sleeve, the fixing block is abutted to the flange, the connecting piece is sleeved on the shaft sleeve and located between the ring piece and the flange, an accommodating space surrounding the peripheral side of the shaft sleeve is formed between the connecting piece and the ring piece, and the soluble piece is located in the accommodating space.

In one embodiment, the fixing block is provided with a liquid passing hole, the liquid passing hole is located on one side of the end surface of the ring piece, which is back to the fixing seat, and when the rotation preventing component is in the first state, the liquid passing hole is communicated with the accommodating space.

In one embodiment, the elastic part is a spring, and two ends of the spring respectively elastically abut against the connecting sheet and the retaining edge.

In one embodiment, an annular blind groove is formed in one side, back to the ring sheet, of the connecting sheet, when the movable seat is installed on the insulating base, the annular blind groove surrounds the periphery of the shaft sleeve, and one end of the spring is accommodated and limited in the annular blind groove.

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

In one embodiment, the expandable part is arranged on one side of the connecting piece, which faces away from the ring piece, and the movable seat is driven by the elastic part, so that the connecting piece has a moving tendency away from the ring piece.

In one embodiment, the expandable member is a plurality of expandable members, and at least 2 of the plurality of expandable members are made of different deformable materials.

In one embodiment, the pacing system comprises an insulating base, the insulating base comprises a shaft sleeve and a flange surrounding the periphery of the shaft sleeve, the connecting sheet and the ring sheet are sequentially sleeved on the shaft sleeve, and the expandable member is clamped between the connecting sheet and the flange.

In one embodiment, one side of the fixed seat, which is far away from the end face of the fixed seat, abuts against the rib, an accommodating space surrounding the peripheral side of the shaft sleeve is formed between the connecting piece and the rib, and the expandable piece is located in the accommodating space.

In one embodiment, the expandable member is made of a liquid-absorbing deformable material, the fixing block is provided with a liquid passing hole, the liquid passing hole is located on one side, back to the end face of the fixing seat, of the ring piece, and when the rotation preventing component is in the first state, the liquid passing hole is communicated with the accommodating space.

In one embodiment, the connecting piece is provided with a through groove, and the liquid passing hole is communicated with the accommodating space through the through groove.

In one embodiment, the expandable member is provided with a liquid suction hole, and the liquid suction hole is communicated with the through groove.

In one embodiment, the through groove comprises an annular portion, when the movable seat is mounted on the insulating base, the annular portion of the through groove surrounds the periphery of the shaft sleeve, 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 of the spring abuts against the ring sheet.

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

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

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

In one embodiment, at least one of the connecting piece and the ring piece is provided with an annular groove, the annular groove is used for accommodating the spring, and when the anti-rotation component is in the second state, the connecting piece abuts against the ring piece.

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

In another aspect, the invention provides a pacing system, including the above-mentioned fixation device.

The fixing device comprises a spiral fixing piece and an anti-rotation assembly, wherein the spiral fixing piece is provided with an insertion end, the anti-rotation assembly comprises a fixing seat and a movable seat, the fixing seat is connected with the spiral fixing piece, the movable seat is circumferentially limited on the fixing seat, the anti-rotation assembly is provided with a first state and a second state, and the fixing seat and the movable seat are both positioned on the back side of the end surface of an electrode base of the pacing system when the anti-rotation assembly is in the first state, so that the screwing-out operation of the spiral fixing piece is not hindered, and the body is prevented from being scratched; prevent changeing the subassembly and be in under the second state, the relative fixing base of movable seat one side protrusion towards the penetrating end to can utilize the movable seat to contact with the organism and rotate with restriction spiral mounting, in order to improve fixing device and organism's stability of being connected.

Drawings

In order to more clearly illustrate the embodiments of the present invention or the technical solutions in the prior art, the drawings used in the embodiments or the prior art descriptions will be briefly described below, it is obvious that the drawings in the following description are only some embodiments of the present invention, and it is obvious for those skilled in the art that drawings of other embodiments can be obtained according to the drawings without creative efforts.

FIG. 1 is a schematic diagram of a portion of a pacing system according to one embodiment, in which an anti-rotation component is in a first state;

FIG. 2 is a schematic partial structural view of a pacing system according to one embodiment, in which the anti-rotation component is in a second state;

fig. 3 is an exploded schematic view of a partial structure of the pacing system of embodiment 1;

FIG. 4 is a cross-sectional view of an anti-rotation component of a fixation device of a pacing system according to one embodiment, wherein the anti-rotation component is in a first state;

FIG. 5 is a structural schematic view of the anti-rotation component of the fixation device shown in FIG. 4 in a second state;

FIG. 6 is an exploded view of a plug and electrode base in another embodiment of a pacing system;

fig. 7 is an exploded schematic view of a portion of the structure of another embodiment of a pacing system;

FIG. 8 is a cross-sectional view of the fixation device of the pacing system of FIG. 7 with an anti-rotation component in a first state;

FIG. 9 is a perspective view of the fixation device of the pacing system of FIG. 7 with an anti-rotation component of the fixation device in a first state;

FIG. 10 is a structural view of the anti-rotation component of the fixing device shown in FIG. 9 in a second state.

Detailed Description

In order to make the aforementioned objects, features and advantages of the present invention more comprehensible, embodiments accompanying figures are described in detail below. In the following description, numerous specific details are set forth in order to provide a thorough understanding of the present invention. This invention may, however, be embodied in many different forms and should not be construed as limited to the embodiments set forth herein.

In the description of the present invention, the terms "first" and "second" are used for descriptive purposes only and are not to be construed as indicating or implying relative importance or implying any number of technical features indicated. Thus, a feature defined as "first" or "second" may explicitly or implicitly include at least one such feature. In the description of the present invention, "a plurality" means at least two, e.g., two, three, etc., unless explicitly specified otherwise.

In the present invention, unless otherwise explicitly stated or limited, the terms "mounted," "connected," "fixed," and the like are to be construed broadly, e.g., as being permanently connected, detachably connected, or integral; can be mechanically or electrically connected; they may be directly connected or indirectly connected through intervening media, or they may be interconnected within two elements or in a relationship where two elements interact with each other unless otherwise specifically limited. The specific meanings of the above terms in the present invention can be understood by those skilled in the art according to specific situations.

Example 1

Referring to fig. 1 and 2, a pacing system 100 according to an embodiment of the present invention includes an electrode base 10, a head electrode 20, and a fixation device.

The head electrode 20 is fixedly connected to the electrode base 10, and has a tip 20a protruding out of the end face 10a of the electrode base 10. The fixation device is used to secure pacing system 100 in the implant position such that tip 20a of head electrode 20 is in stable contact with the body so that pacing system 100 exerts its pacing efficacy.

It is specifically noted that the pacing system 100 of the present invention may be either a balloon pulse generator plus electrode lead mode pacing system 100 or a leadless pacemaker in which the leadless pacemaker is itself a separate generator and electrode system implanted directly into the right ventricle through the femoral vein and does not require a chest incision or subcutaneous balloon, thereby eliminating various complications associated with leads in conventional pacemakers, such as a balloon infection, hematoma, lead dislodgement, or lead rupture. And looks more aesthetically pleasing due to the absence of a chest incision or visible pacemaker pocket.

The type of pacing system 100 in the present invention is not limited thereto. Specifically, the fixation device in pacing system 100 of the present invention is configured to meet all of the fixation requirements of pacing system 100, as long as the implant site allows.

Specifically, as shown in fig. 1 and 2, the fixing device includes a fixing member 30 and an anti-rotation component 40. One end of the fixing member 30 is connected to the rotation preventing member 40, and the other end forms a piercing end 30a. The fixing member 30 may be a radial anchoring claw or a spiral anchoring claw. When the fixing member 30 is helical, the piercing end 30a may be used to pierce the body and the fixing member 30 may be screwed into the body by rotation when the pacing system 100 needs to be fixed to the body. The pacing system 100 is finally secured to the body using the securing member 30 such that the tip 20a of the head electrode 20 is in contact with the body.

For the convenience of understanding the technical solution, the following description will be given 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 practice, after pacing system 100 is secured such that tip 20a of head electrode 20 is in contact with the body, electrical performance of pacing system 100 may need to be measured to confirm that the implant site and contact condition meet electrical performance requirements. If the electrical properties are not satisfactory, the fastener 30 may need to be disengaged from the body to re-find the proper fastening location. The present embodiment adopts such a spiral fixing member 30, which greatly facilitates the screwing-in and unscrewing operations.

The anti-rotation component 40 functions to limit the rotation of the securing member 30 out of the body by contacting the body so that the pacing system 100 is stably secured to the body. Specifically, in the pacing system 100 of the present invention, 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 a first state, and in this state, when the fixing device is fixed to the body, the anti-rotation component 40 does not contact with the body, and thus does not interfere with the unscrewing operation, so that when the electrical performance of the pacing system 100 does not meet the requirement, the fixing position can be flexibly adjusted. Referring to fig. 2, the anti-rotation component 40 is in a second state and is fixed to the body fixing device, and when the anti-rotation component 40 is in the second state, the anti-rotation component 40 contacts with the body to limit the fixing member 30 from being screwed out of the body. That is, the rotation prevention assembly 40 can adjust the timing for limiting the rotation of the fixing member 30 out of the body by switching from the first state to the second state, so that the fixing stability of the pacing system 100 can be effectively enhanced in the second state, and the rotation prevention assembly can be used to reduce the difficulty of the rotation operation in the first state and avoid scratching the body.

The anti-rotation assembly 40 may be configured to have the first state and the second state described above.

Specifically, as shown in fig. 3, the anti-rotation assembly 40 includes a fixed seat 41 and a movable seat 42.

The fixing base 41 is connected to the fixing member 30, for example, the fixing base 41 is integrally formed with the fixing member 30, or the fixing member 30 is welded and fixed to the fixing base 41.

The movable seat 42 is circumferentially limited on the fixed seat 41, i.e. in the direction around the central line of the fixing member 30, the movable seat 42 and the fixed seat 41 cannot rotate relatively. Then, when the rotation preventing assembly 40 rotates around the center line direction of the fixed member 30, the fixed member 30 rotates together with the movable seat 42 and the fixed seat 41, and finally the fixed member 30 is screwed into or out of the body. In this embodiment, the movable seat 42 can move toward the side of the puncturing end 30a relative to the fixed seat 41, so that the rotation preventing member 40 can have the first state and the second state by utilizing the position change of the movable seat 42 relative to the fixed seat 41 in the direction along the center line of the fixed member 30.

As shown in fig. 4, when the rotation preventing assembly 40 is in the first state, the movable seat 42 and the fixed seat 41 are both located on a back side of the end surface 10a of the electrode base 10, where the back side refers to a side of the end surface 10a away from the end 20a, that is, neither the movable seat 42 nor the fixed seat 41 protrudes from a plane where the end surface 10a of the electrode base 10 is located. Thus, when the fixing member 30 fixes the pacing system 100 to the body, even if the end surface 10a of the electrode base 10 contacts the body to ensure the end 20a of the head electrode 20 to effectively contact the body, neither the movable seat 42 nor the fixed seat 41 contacts the body. Then, when the anti-rotation component 40 is in the first state, the anti-rotation component 40 will not contact with the body, so that when the fixing member 30 is screwed out of the body, the anti-rotation component 40 will not increase the difficulty of the screwing-out operation of the fixing member 30, and scratch of the body is avoided. The movable seat 42 and the fixed seat 41 do not protrude 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, one sides of the movable seat 42 and the fixed seat 41 close to the end 20a may be flush with each other or not, as long as the sides do not protrude from the plane where the end face 10a of the electrode base 10 is located, preferably, the flush is performed, so that the instrument structure is more compact and firmer, and the appearance is smooth and easy to operate.

Referring to fig. 5, when the rotation preventing assembly 40 is in the second state, the movable seat 42 protrudes from the fixed seat 41 toward the piercing end 30a and is used for contacting with the body, so that the movable seat 42 contacts with the body to limit the fixed element 30 from rotating reversely, thereby preventing the fixed element 30 from rotating out of the body.

It should be noted that, the protrusion of the movable seat 42 relative to the fixed seat 41 means that the end surface 42a of the movable seat 42 protrudes relative to the end surface 41a of the fixed seat 41 toward the plane of the end surface 10a of the electrode base 10, so that the movable seat 42 can contact with the body, the anti-torsion performance of the pacing system 100 relative to the body is improved, and the fixation member 30 is restricted from being screwed out of the body.

As shown in fig. 3, the fixing base 41 includes a ring piece 411 and a plurality of fixing blocks 412, and the fixing blocks 412 are arranged around the outer side of the ring piece 411 at intervals; the movable base 42 includes a connecting plate 421 and a plurality of movable blocks 422, and the plurality of movable blocks 422 are disposed around the outer side of the connecting plate 421 at intervals.

The plurality of movable blocks 422 and the plurality of fixed blocks 412 are alternately arranged in the circumferential direction, and the connection piece 421 is located on the side of the ring piece 411 facing away from the end surface 10a of the electrode base 10. In some embodiments, after the plurality of movable blocks 422 and the plurality of fixed blocks 412 are alternately embedded with each other, a ring structure is formed, the ring structure is disposed around the circumference of the electrode base 10, and when the anti-rotation component 40 is in the second state, the plurality of movable blocks 422 protrude relative to the plurality of fixed blocks 412, so that the anti-rotation component 40 has convex-concave characteristics to form a stable grip effect on the body, thereby preventing the fixing member 30 from being unscrewed from the body to stably fix the pacing system 100.

The ring structure formed by the plurality of movable blocks 422 and the plurality of fixed blocks 412 being fitted may be a standard ring structure, i.e., a ring having a circular cross section. In other embodiments, the ring structure may not be a standard circular ring structure, for example, a ring structure having a square or oval cross-section. Specifically, the movable blocks 422 and the fixed blocks 412 are only required to be engaged with each other so that the movable seat 42 is axially limited on the fixed seat 41 and can axially move relative to the fixed seat 41, so as to switch the anti-rotation assembly 40 from the first state to the second state.

Referring to fig. 1 and 2 again, in some embodiments, the movable block 422 is provided with a groove 42b, and the groove 42b penetrates 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 assembly 40 is in the second state, and the end surface 42a of the movable seat 42 contacts with the body, the groove 42b can be embedded by a part of the body tissue, thereby improving the anchoring force and better limiting the rotation of the fixing element 30 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 rotation direction of the stationary member 30 with respect to the end surface 42a of the movable seat 42. Here, the rotation direction of the fixing member 30 refers to a rotation direction in which the fixing member 30 is rotated into the body. In this embodiment, the obliquely disposed U-shaped or V-shaped grooves provide greater blocking force to prevent the fixation member 30 from unscrewing from the body, which in turn improves the stability of the connection of pacing system 100 to the body.

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

It should be noted that "flush" includes both the case where the end face 42a of the movable seat 42 is located on the same plane as the end face 10a of the electrode base 10 and the case where the end face 42a of the movable seat 42 has a height difference with the end face 10a of the electrode base 10 that is almost negligible, for example, the height difference between the end face 42a of the movable seat 42 and the end face 10a of the electrode base 10 is less than or equal to 3mm, as long as the end face 42a of the movable seat 42 contacts with the body when the anti-rotation assembly 40 is in the second state, and the torque of the fixed member 30 that is reversely rotated out of the body is increased, so that the movable seat 42 can play a better anti-rotation effect. Wherein the fixing member 30 is unscrewed from the body in the opposite direction means that the fixing member 30 is unscrewed from the body in the opposite direction to the direction in which the body is screwed.

As shown in connection with fig. 3-5, the anti-rotation assembly 40 includes a dissolvable member 43 and a spring 44.

Wherein, the dissoluble piece 43 is arranged between the fixed seat 41 and the movable seat 42. Specifically, the dissolvable piece 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 (i.e. the relative position is fixed), for example, the spring 44 is fixedly connected to 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 fixed relative to the movable seat 42. The other end of the spring 44 is fixed relative to the fixed seat 41 (i.e. the relative position is fixed), 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 surface of the movable seat 42 is connected to the fixed seat 41 through the dissolvable member 43, the back surface is connected to the fixed seat 41 through the spring 44, and the spring 44 is in a compressed state, wherein the front surface is a side close to the end surface 10a, and the back surface is a side far from the end surface 10 a. In other embodiments, the dissolvable part 43 contacts with the front surface of the movable seat 42, the movable seat 42 is kept to abut against the dissolvable part 43 under the urging of the spring 44, and as the volume of the dissolvable part 43 is reduced, the spring 44 urges the movable seat 42 to move towards the puncturing 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 an elastic force to the movable seat 42, and the connecting piece 421 has a moving tendency to approach the ring piece 411 under the driving of the spring 44 of the movable seat 42. Specifically, under the action of the elastic force of the spring 44, the connecting piece 421 and the ring piece 411 clamp the dissolvable piece 43, so that as the dissolvable piece 43 is dissolved, the connecting piece 421 gradually approaches the ring piece 411, and then the movable seat 42 moves towards the side close to the end face 10a of the electrode base 10 relative to the fixed seat 41, and finally the rotation preventing component 40 enters the second state.

In addition to the dissolvable member 43, a compressible member whose internal volume can be reduced may be used, and the dissolvable member 43 and the compressible member are collectively referred to as a reducible member. The spring 44 may alternatively be other resilient members such as rubber, thermoplastic elastomers, etc. The elastic element only needs to provide a force for the movable seat 42 to move towards the front, for example, the front of the movable seat 42 may be connected to the fixed seat 41 through the elastic element in a stretching state.

It should be noted that the dissolvable member 43 can dissolve in a specific time period or environment, so that as the dissolvable member 43 dissolves, the connecting plate 421 gradually approaches the ring plate 411 under the driving of the spring 44 by the movable seat 42, so that the movable blocks 422 connected with the connecting plate 421 will move relative to the fixed blocks 412 on the ring plate 411. As shown in fig. 4 and 5, after the dissolvable member 43 is completely dissolved, the movable block 422 extends out from the end surface 41a of the fixed seat 41, so that the anti-rotation assembly 40 is in the second state, and the fixing member 30 is restricted from being rotated out of the body by the contact between the movable block 422 and the body.

The dissolvable member 43 may be made of a solid drug that dissolves in blood, such as a solid substance like a steroid antiphlogistic, a capsule sugar coat, etc. Even if the dissolvable piece 43 is dissolved in blood, no side effect will be generated, and the dissolvable piece 43 made of the solid drug can also exert the beneficial effects of the corresponding drug after being dissolved in blood, just as the dissolvable piece 43 made of the sterol anti-inflammatory drug can exert good anti-inflammatory effect after being dissolved in blood, so as to eliminate the possible inflammation at the body piercing position of the fixing member 30, thereby being beneficial to the recovery of the wound.

In other embodiments, the dissolvable member 43 may be made of other non-drug component materials. Preferably, the dissolvable member 43 is made of a material harmless to human body and capable of dissolving in blood within a certain time, and the material of the dissolvable member 43 is not described herein.

The time required for complete dissolution of dissolvable piece 43 is related to the material, size, and environment in which dissolvable piece 43 is located. For example, in some embodiments, using a 2mm thick, 5mm diameter disk-shaped dissolvable member 43 supported by a sterol anti-inflammatory drug, it takes 60 minutes for dissolvable member 43 to dissolve completely in the blood upon entry into the body with pacing system 100, meaning that it takes 60 minutes for anti-rotation component 40 to change from the first state to the second state using dissolvable member 43.

It should be noted that, in practical application, the material and size of the dissolvable member 43 can be configured reasonably according to practical requirements to adjust the time length of complete dissolution, so as to achieve the purpose of adjusting and controlling the time length of the anti-rotation component 40 entering the second state to exert the anti-rotation performance.

Referring to fig. 4 and 5, in the process of dissolving the dissolvable member 43, the elastic force of the spring 44 moves the movable seat 42 relative to the fixed seat 41, and finally when the dissolvable member 43 is completely dissolved, the rotation-preventing component 40 is in the second state to play a role of limiting the fixing member 30 from rotating out of the body. Thus, the time period of dissolution of the dissolvable part 43, that is, the time period of the anti-rotation component 40 changing from the first state to the second state, effectively delays the timing of the anti-rotation component 40 playing the anti-rotation role, that is, after a certain time period passes after the pacing system 100 is implanted into the body, the anti-rotation component 40 enters the second state along with the dissolution of the dissolvable part 43.

Thus, after the pacing system 100 having such an anti-rotation component 40 is implanted in the body, the time-delay effect of the anti-rotation component 40 allows sufficient time for the back-out and back-in operation even if the implantation site is not ideal or the electrical performance is not satisfactory, and prevents the anti-rotation prevention structure from contacting the body during such repeated operations, thereby reducing the difficulty of the operation and reducing the damage to the body.

In the embodiment of utilizing dissolvable piece 43 to dissolve in blood for anti-rotation component 40 gradually enters the second state, when implanting pacing system 100 in the appropriate position, meeting the electrical performance requirement, need not follow-up operation, along with dissolvable piece 43 dissolves in blood, anti-rotation component 40 just can enter the second state by oneself and ensure pacing system 100 fixed stability, greatly improves the simple operation and the security of pacing system 100.

In some embodiments, thickness d of dissolvable member 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 piece 43 refers to the thickness of the dissolvable piece 43 when not dissolved, that is, the initial thickness when the dissolvable piece 43 is sandwiched between the connecting piece 421 and the ring piece 411, that is, when the rotation preventing assembly 40 is in the first state, the distance between the connecting piece 421 and the ring piece 411 is also d. Thus, when the anti-rotation assembly 40 is in the second state, since the dissolvable part 43 is completely dissolved, the connecting piece 421 contacts the ring piece 411, and the distance d that the connecting piece 421 moves relative to the ring piece 411 is then set. In this embodiment, the thickness d of the dissolvable member 43 ranges from 1mm to 5mm, so that the moving distance of the connecting sheet 421 relative to the ring sheet 411 can be effectively controlled, and the moving distance of the movable block 422 connected to the connecting sheet 421 can meet the functional requirements of the anti-rotation assembly 40 in the first state and the second state, specifically, the movable block 422 is located on the back side of the end surface 10a of the electrode base 10 in the first state of the anti-rotation assembly 40, so as not to increase the difficulty in the operation of the fixing member 30 rotating out of the body; in the second state of the anti-rotation assembly 40, the movable block 422 is moved by a distance d relative to the fixed base 41, and finally the movable block 422 can contact with the body, so as to limit the fixing member 30 from rotating out of the body, thereby improving the fixing stability of the fixing device and the body.

As shown in fig. 3 and 4, the pacing system 100 includes an insulating base 50, where the insulating base 50 includes a shaft sleeve 51 and a rib 52 surrounding the shaft sleeve 51. Electrode base 10 wears to locate axle sleeve 51, and axle sleeve 51 outside is all located to the cover ring 411 and connection piece 421 cover, utilizes axle sleeve 51 to realize radially spacing to fixing base 41 and sliding seat 42 for sliding seat 42 and fixing base 41 are radially spacing in axle sleeve 51, and because sliding seat 42 circumference is spacing in fixing base 41, thereby sliding seat 42 only can be relative fixing base 41 axial displacement, and the improvement prevents changeing subassembly 40 and is changed to the stability of second state by first state.

It should be noted that, as shown in fig. 4, the ring piece 411 has an inner hole 411a, the diameter of the inner hole 411a is equal to the outer diameter of the shaft sleeve 51, and after the fixing base 41 is assembled on the insulating base 50, the shaft sleeve 51 is matched 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 outside the shaft sleeve 51 by using the shaft hole 421 a. The sleeve 51 is fitted over the tip electrode 20, and fixes the tip electrode 20.

In some embodiments, after the fixing base 41 is assembled on the insulation 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 insulation base 50. In this embodiment, when the fixing block 412 of the fixing base 41 abuts against the rib 52, the ring piece 411 and the rib 52 are spaced apart, the connecting piece 421 is located between the ring piece 411 and the rib 52, and the soluble piece 43 is clamped between the connecting piece 421 and the ring piece 411. Specifically, since the ring piece 411 and the connecting piece 421 are both sleeved outside the shaft sleeve 51, an accommodating space surrounding the circumference of the shaft sleeve 51 is formed between the ring piece 411 and the connecting piece 421, so that the dissolvable piece 43 is disposed by using the accommodating space.

Furthermore, the fixing block 412 is provided with a liquid passing hole 41b, the liquid passing hole 41b is located on a side of the ring piece 411 facing away from the end surface 41a of the fixing seat 41, when the anti-rotation component 40 is in the first state, the liquid passing hole 41b is communicated with the accommodating space, so that after the pacing system 100 is implanted into the body, blood can enter the accommodating space where the dissolvable component 43 is located through the liquid passing hole 41b, thereby facilitating the dissolution of the dissolvable component 43 in the blood, avoiding less blood entering the accommodating space, easily causing the slow dissolution efficiency of the dissolvable component and causing the anti-rotation component 40 to enter the second state to play the role of anti-rotation.

It should be noted that, the arrangement manner 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 towards the side where the end surface 10a of the electrode base 10 is located relative to the fixed seat 41, during the process of dissolving the dissolvable piece 43, the spring 44 drives the movable seat 42 towards the side where the end surface 10a of the electrode base 10 is located, and finally the rotation preventing component 40 enters the second state.

For example, in some embodiments, the connecting piece 421 has an annular blind groove 42c on a side facing away from the ring piece 411, when the movable seat 42 is mounted on the insulating base 50, the annular blind groove 42c surrounds the outer periphery of the shaft sleeve 51, one end of the spring 44 is received and limited in the annular blind groove 42c, and 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 piece 43 between the connection piece 421 and the ring piece 411 is dissolved, the elastic force of the spring 44 can drive the connection piece 421 to approach the ring piece 411.

The annular blind groove 42c of the connecting piece 421 can improve the installation stability of the spring 44, and at the same time, at least part of the structure of the spring 44 can be accommodated, 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 whole structure of the spring 44 is accommodated in the annular blind groove 42 c. By means of the structure, the fixing device is small in overall structure, overall size is reduced, and long-term fixing in vivo is facilitated.

In other embodiments, the connecting piece 421 is not provided with the annular blind groove 42c, and two ends of the spring 44 respectively elastically abut against the connecting piece 421 and the rib 52 of the insulating base 50. There are other situations for the way in which the spring 44 is arranged in the fixing device, and a detailed description thereof is omitted.

In the embodiment shown in connection with fig. 3 in which pacing system 100 includes insulating base 50, pacing system 100 includes connector 60, seal 70, and feedthrough 80.

Wherein the connector 60 is connected to a side of the insulating base 50 facing away from the rotation-preventing member 40, the fixing device can be assembled to the pacing system 100 using the connector 60. For example, where pacing system 100 is a leadless pacemaker, connector 60 is attached to a package housing (not shown) of the leadless pacemaker, which may be made of titanium. For another example, the side of the connecting member 60 remote from the insulating base 50 is connected to an electrode lead main body (not shown).

The seal 70 is used to mount the body of the feedthrough 80 and is connected to the connector 60. A good liquid-tight effect can be achieved with the seal 70, so that the seal 70, the connection 60, the feedthrough 80 and the package housing form a completely sealed space; wherein the body of the feedthrough 80 is mounted on the sealing member 70, one end of the guide wire 801 of the feedthrough 80 is electrically connected to the head electrode 20 mounted on the electrode base 10 through the sealing channel, and the other end of the guide wire 801 of the feedthrough 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, a suppository 90 is sleeved on an end of the electrode base 10 near the end face 10a, so that after the fixing device of the pacing system 100 is fixed on the body, the suppository 90 is used to carry corresponding drugs to improve the therapeutic effect. Specifically, as shown in fig. 1, the suppository 90 is sleeved outside the electrode base 10, and the end surface 90a of the suppository 90 is substantially flush with the end surface 10a of the electrode base 10, so that after the fixing device of the pacing system 100 is fixed on the body, the end surface 90a of the suppository 90 contacts the body to exert corresponding drug effects.

In the above embodiment, the anti-rotation assembly 40 gradually enters the second state from the first state by the change of the body shape caused by the dissolution of the dissolvable piece 43, and the dissolution process of the dissolvable piece 43 has a certain delay effect on the anti-reverse effect of the anti-rotation assembly 40.

In other embodiments, other body-shape-changeable members may be disposed 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, referring to fig. 7, in the embodiment 2 provided by the present application, the anti-rotation component 40 is provided with the expandable part 43 ', and the anti-rotation component 40 is changed from the first state to the second state by using the deformation of the expandable part 43' for a certain time or under a certain condition.

Example 2

As shown in fig. 7 and 8 in conjunction, the configuration of the pacing system 100' according to embodiment 2 is substantially the same as that of the pacing system 100 according to embodiment 1.

Specifically, the pacing system 100 ' of this embodiment 2 includes an electrode base 10 ', a head electrode 20 ', and a fixation device.

The head electrode 20 ' is fixedly connected with the electrode base 10 ' and has a tip 20a ' extending out of the end face 10a ' of the electrode base 10 '. The fixation device is used to fix pacing system 100 'in the implanted position such that tip 20 a' of head electrode 20 'is in stable contact with the body so that pacing system 100' exerts its pacing efficacy.

The fixing device includes a fixing member 30 'and an anti-rotation assembly 40'. One end of the fixing member 30 ' is connected to the rotation preventing member 40 ' and the other end forms a piercing end 30a '.

The anti-rotation component 40' has a first state and a second state. As shown in fig. 9, the anti-rotation member 40 ' is in a first state in which the anti-rotation member 40 ' does not contact the body when the fixing device is fixed to the body, and thus does not interfere with the unscrewing operation, so that the fixing position can be flexibly adjusted when the electrical performance of the pacing system 100 ' is not satisfactory. Referring to fig. 10, the anti-rotation component 40 'is in a second state and is fixed to the fixing device of the body, and when the anti-rotation component 40' is in the second state, the anti-rotation component 40 'contacts with the body to limit the rotation of the fixing member 30' out of the body. That is, the rotation preventing assembly 40 ' can adjust the time for limiting the fixing member 30 ' to rotate out of the body by switching from the first state to the second state, so that the fixing stability of the pacing system 100 ' can be effectively enhanced in the second state, and the rotation preventing assembly can reduce the difficulty of rotation out in the first state and avoid scratching the body.

The rotation-proof assembly 40 ' includes a fixed seat 41 ', a movable seat 42 ', an expandable member 43 ' and a spring 44 '. The pacing system 100 ' of embodiment 2 differs from the pacing system 100 ' of embodiment 1 in that in the pacing system 100 ' of embodiment 2, the anti-rotation component 40 ' is provided with the expandable component 43 ', instead of the dissolvable component 43 in embodiment 1, the volume change of the expandable component 43 ' is utilized to gradually move the movable seat 42 ' relative to the fixed seat 41 ', so that the anti-rotation component 40 ' changes from the first state to the second state to have the effect of delaying the anti-rotation. In some embodiments, the spring 44 may be replaced with other resilient members, such as rubber, thermoplastic elastomers, and the like. In short, the elastic member is used to make the movable seat 42 'abut against 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, so that the movable seat 42' moves toward the piercing end 30a 'relative to the fixed seat 41'.

It should be noted that there are many possible positions for the elastic member, for example, in some embodiments, the front surface of the movable seat 42 'is connected to the fixed seat 41' through the elastic member in a compressed state, and the back surface is connected to the fixed seat 41 'through the expandable member 43', wherein the front surface is the side close to the end surface 10a 'and the back surface is the side far from the end surface 10 a'. The back of the movable seat 42 'may be connected to the fixed seat 41' via an elastic member in a stretched state, and the elastic member only needs to provide a force to the movable seat 42 to move to the front. Specifically, the fixed holder 41 'and the movable holder 42' in this embodiment 2 are similar in structure to those in embodiment 1.

Referring to fig. 7, the fixing base 41 ' includes a ring plate 411 ' and a plurality of fixing blocks 412 ', and the fixing blocks 412 ' are spaced around the outer side of the ring plate 411 '. The movable seat 42 ' includes a connection plate 421 ' and a plurality of movable blocks 422 ', and the plurality of movable blocks 422 ' are arranged around the outer side of the connection plate 421 ' at intervals.

As shown in fig. 8 to 10, the fixed blocks 412 'and the movable blocks 422' are alternately arranged along the circumferential direction, for example, the fixed blocks and the movable blocks are alternately embedded with each other, and the connecting piece 421 'is located on the side of the ring piece 411' facing away from the end surface 10a 'of the electrode base 10'.

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

Referring to 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 adapted to contact with the body, so that the movable seat 42' contacts with the body to limit the reverse rotation of the fixing member 30 ', thereby preventing the fixing member 30' from rotating out of the body.

In some embodiments, the movable block 422 'has a groove 42 b', and the groove 42b 'penetrates the end face 42 a' of the movable seat 42 ', so that when the anti-rotation assembly 40' is in the second state, and the end face 42a 'of the movable seat 42' contacts with the body, the groove 42b 'can be embedded by a portion of the body tissue, thereby increasing the anchoring force to better limit the rotation of the fixing element 30' 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 rotation direction of the stationary member 30' with respect to the end surface 42a 'of the movable seat 42'. The screwing direction of the fixing member 30 'refers to a rotating direction in which the fixing member 30' is screwed into the body. In this embodiment, the obliquely disposed U-shaped or V-shaped grooves provide greater blocking force to prevent the fixation member 30 'from unscrewing from the body, which in turn improves the stability of the connection of the pacing system 100' to the body.

The expandable member 43 'is disposed on a side of the connecting piece 421' opposite to the ring piece 411 ', and the expandable member 43' is a temperature-sensitive deformable material, a light-induced deformable material or a liquid-absorbing deformable material. The spring 44 'is elastically disposed between the movable seat 42' and the fixed seat 41 ', and keeps the connecting piece 421' in contact with the expandable piece 43 ', and when the expandable piece 43' expands, the expandable piece 43 'drives the connecting piece 421' to approach the ring piece 411 ', so that the anti-rotation component 40' moves from the first state to the second state.

In this embodiment, when the expandable member 43 'is not expanded, the rotation preventing assembly 40' is in the first state, and as the expandable member 43 'expands, the connecting piece 421' approaches the ring piece 411 ', and then the movable block 422' connected to the connecting piece 421 'moves toward the side of the end face 10 a' of the electrode base 10 'relative to the fixed block 412' of the fixed seat 41 ', so that the rotation preventing assembly 40' is finally switched from the first state to the second state.

It should be noted that the expandable member 43 'may be plural, and at least 2 of the plural expandable members 43' may be made of different deformable materials. Therefore, different measures can be adopted to expand the corresponding expandable piece 43 ', so that the moving distance of the connecting piece 421' relative to the ring piece 411 'can be accurately controlled, the regulation and control process of the anti-rotation component 40' is more precise, and the improvement of the operation safety is facilitated.

The temperature-sensitive deformation material comprises poly-N-isopropylacrylamide, and can obtain an expansion effect when the temperature of the temperature-sensitive deformation material is increased, and then the expandable part 43 'made of the temperature-sensitive deformation material can be adapted to drive the movable seat 42' to move relative to the fixed seat 41 ', so that the requirement that the anti-rotation component 40' is moved from the first state to the second state is met.

The photo-deformable material comprises cinnamic acid derivative polymer, and when it is determined that the electrical performance of the pacing system 100 ' is normal, infrared light is adopted to penetrate through the skin at the corresponding position, so that the photo-deformable material expands, and therefore, the expandable part 43 ' adopting the photo-deformable material can drive the movable seat 42 ' to move relative to the fixed seat 41 ', and the effect of moving the anti-rotation component 40 ' from the first state to the second state is achieved.

The liquid-absorbent deformable material includes a sodium polyacrylate-based high liquid-absorbent resin. Thus, when the expandable member 43 'is made of liquid-absorbing deformation material, the expandable member 43' can absorb the moisture in the blood and gradually expand, and then generate a pressing force on the connecting piece 421 'of the movable seat 42' during the expansion process, so that the movable seat 42 'moves relative to the fixed seat 41', and the rotation-preventing component 40 'is switched to the second state, so as to prevent the fixing member 30' from rotating out of the body, thereby improving the stability of the connection between the fixing device and the body.

In this embodiment 2, with reference to fig. 7 and 8, a 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 connecting piece 421 'and the ring piece 411' are sequentially sleeved on the shaft sleeve 51 ', the expandable piece 43' is clamped between the connecting piece 421 'and the retaining edge 52', so that when the expandable piece 43 'expands, the retaining edge 52' limits the expandable piece 43 ', the expandable piece 43' expands towards the side where the connecting piece 421 'is located, and the connecting piece 421' is driven to approach the ring piece 411 ', so that the movable block 422' on the connecting piece 421 'moves towards the end face 10 a' of the electrode base 10 'relative to the fixed block 412' on the ring piece 411 ', and finally the rotation preventing component 40' enters a second state, and the fixed piece 30 'is prevented from rotating out of the body by utilizing the contact of the movable block 422' and the body.

Referring to fig. 8, the side of the fixing seat 41 'away from the end surface 41 a' abuts against the rib 52 ', an accommodating space surrounding the circumference of the shaft sleeve 51' is formed between the connecting piece 421 'and the rib 52', and the expandable member 43 'is located in the accommodating space, so that the anti-rotation assembly 40' has a compact overall structure.

When the expandable member 43 ' is made of liquid-absorbing deformation material, the fixing block 412 ' is provided with a liquid passing hole 41b ', the liquid passing hole 41b ' is located on the side of the annular plate 411 ' facing away from the end surface 41a ' of the fixing seat 41 ', and when the rotation preventing component 40 ' is in the first state, the liquid passing hole 41b ' is communicated with the accommodating space, so that blood can enter the accommodating space when the pacing system 100 ' is implanted into the body, thereby adapting to the requirement of expansion deformation of the expandable member 43 '.

As shown in fig. 8, the connecting piece 421 'is provided with a through slot 42 c', and the liquid passing hole 41b 'is communicated with the accommodating space through the through slot 42 c', in this structure, the through slot 42c 'is provided by the connecting piece 421', so that the overall volume of the anti-rotation assembly 40 'is not affected, and simultaneously, the requirement of the expandable piece 43' for expansion and deformation can be met when blood enters the accommodating space.

Furthermore, the expandable member 43 ' is provided with a liquid absorbing hole 43a ', and the liquid absorbing hole 43a ' is communicated with the through groove 42c ', so that the efficiency of absorbing moisture of the expandable member 43 ' is improved by using the liquid absorbing hole 43a ', and the expansion speed of the expandable member 43 ' is reasonably controlled.

As shown in fig. 8, the through slot 42c ' includes an annular portion, when the movable seat 42 ' is mounted on the insulating base 50 ', the annular portion of the through slot 42c ' surrounds the outer periphery of the shaft sleeve 51 ', one end of the spring 44 ' is received in the annular portion of the through slot 42c ', and the other end of the spring 44 ' abuts against the annular plate 411 ', so that the through slot 42c ' provides a mounting space for the spring 44 ', thereby improving the compactness of the overall structure, making the fixing device smaller and more compact, and facilitating the improvement of the 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 whole structure of the spring 44 ' is accommodated in the annular portion of the through slot 42c ', so that the anti-rotation assembly 40 ' is in the second state, the spring 44 ' is accommodated in the annular portion of the through slot 42c ', the whole mechanism of the anti-rotation assembly 40 ' is compact, and the occupied space is small.

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 liquid passing hole 41b ', so that the liquid passing hole 41b ' can be sealed, and the blood is prevented from continuously entering the accommodating space, so that the expandable member 43 ' can maintain a reasonable expansion degree, the pressing force between the internal components of the anti-rotation assembly 40 ' is reduced, and the overall structural stability is improved.

Of course, in some embodiments, the material or size of the expandable member 43 ' may be set such that when the expandable member 43 ' is fully expanded, the anti-rotation assembly 40 ' is in the second state, and the pressing force between the internal components is controlled within a reasonable range. For example, in some implementations, the initial thickness h of the expandable member 43 'is 1mm, and after the expandable member 43' is fully expanded by absorbing moisture, the thickness of the expandable member 43 'is 3mm, that is, the expansion of the expandable member 43' drives the movable seat 42 'to move 2mm relative to the fixed seat 41', so that the pressing force of the expandable member 43 'on the movable seat 42' is reduced as little as possible while maintaining the reverse rotation prevention in the second state.

In the above embodiment, the position where the spring 44 'is provided is not limited to the case where the expandable member 43' is a liquid-absorbent deformable material.

Specifically, regardless of the deformable material of the expandable member 43'. The setting positions of the springs 44 ' may be set between the connecting piece 421 ' and the ring piece 411 ', so long as the connecting piece 421 ' is kept against the expandable piece 43 ', so that the expansion deformation of the expandable piece 43 ' can drive the connecting piece 421 ' to gradually approach the ring piece 411 ', and the anti-rotation assembly 40 ' can be moved from the first state to the second state.

Furthermore, at least one of the connecting piece 421 'and the ring piece 411' is provided with an annular groove (similar to the annular part structure of the through groove 42c '), the annular groove is used for accommodating the spring 44', when the anti-rotation component 40 'is in the second state, the connecting piece 421' abuts against the ring piece 411 ', so that the anti-rotation component 40' is kept in the second state, and the spring 44 'can be effectively accommodated in the annular groove, thereby being beneficial to the miniaturization of the whole structure of the anti-rotation component 40'.

As further shown in fig. 7, the pacing system 100 ' of this embodiment 2 is similar to embodiment 1, with the pacing system 100 ' further including a coupling 60 ', a seal 70 ', and a feedthrough 80 '.

Wherein the connecting member 60 ' is connected to a side of the insulating base 50 ' facing away from the rotation preventing member 40 ', and the fixing device can be assembled to the pacing system 100 ' using the connecting member 60 '. For example, where the pacing system 100 'is a leadless pacemaker, the connector 60' is connected to a package housing (not shown) of the leadless pacemaker, which may be made of titanium. For another example, the side of the connecting member 60 'remote from the insulating base 50' is connected to the electrode lead main body.

The seal 70 ' is used to mount the body of the feedthrough 80 ' and is connected to the connector 60 '. A good liquid seal is achieved with the seal 70 ', so that the seal 70', the connection piece 60 ', the feed-through 80' and the package housing form a completely sealed space. Wherein the body of the feedthrough 80 ' is mounted on the sealing member 70 ', one end of the wire 801 ' of the feedthrough 80 ' is electrically connected to the head electrode 20 ' mounted on the electrode base 10 ' through the sealing channel, and the other end of the wire 801 ' of the feedthrough 80 ' is electrically connected to the electrical components of the pacing system 100 ', e.g., the other end of the wire 801 ' of the feedthrough 80 ' is electrically connected to the electrical components of the leadless pacemaker or to a wire inside the electrode lead.

The electrode base 10 ' is sleeved with a suppository 90 ' at one end near the end face 10a ' thereof, so that after the fixing device of the pacing system 100 ' is fixed on a human body, the suppository 90 ' is used for carrying corresponding medicines to improve the curative effect. Specifically, as shown in fig. 9 and 10, the drug plug 90 ' is sleeved outside the electrode base 10 ', and the end surface 90a ' of the drug plug 90 ' is substantially flush with the end surface 10a ' of the electrode base 10 ', so that after the fixing device of the pacing system 100 ' is fixed to the body, the end surface 90a ' of the drug plug 90 ' contacts with the body to exert corresponding drug effects.

The technical features of the above embodiments can be arbitrarily combined, and for the sake of brevity, all possible combinations of the technical features in the above embodiments are not described, but should be considered as the scope of the present specification as long as there is no contradiction between the combinations of the technical features.

The above examples only show several embodiments of the present invention, and the description thereof is specific and detailed, but not to be construed as limiting the scope of the invention. It should be noted that, for a person skilled in the art, several variations and modifications can be made without departing from the inventive concept, which falls within the scope of the present invention. Therefore, the protection scope of the present patent should be subject to the appended claims.

Claims

1. A fixing device is arranged on a pacing system, the pacing system comprises an electrode base and a head electrode fixed on the electrode base, and the head electrode is provided with a tip extending out of the end face of the electrode base; the fixing device is used for fixing with the organism so that the tip of head electrode contacts with the organism, its characterized in that, fixing device includes:

a fixing member having a piercing end; and

2. The device according to claim 1, wherein the anti-rotation assembly comprises a reducible member in contact with the front face of the movable seat and an elastic member for urging the movable seat to move relative to the fixed seat toward the piercing end when the volume of the reducible member is reduced; alternatively, the first and second electrodes may be,

the anti-rotation component comprises an expandable part and an elastic part, the expandable part is located on the back face of the movable seat, the elastic part is used for enabling the movable seat to abut against the expandable part, and 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 enable the movable seat to move towards the penetrating end relative to the fixed seat.

3. The fixing device according to claim 2, wherein the fixing seat comprises a ring piece and a plurality of fixing blocks, the fixing blocks are arranged around the outer side of the ring piece at intervals, the movable seat comprises a connecting piece and a plurality of movable blocks, the movable blocks are arranged around the outer side of the connecting piece at intervals, the fixing blocks and the movable blocks are arranged alternately in the circumferential direction, and the connecting piece is located on one side, facing away from the end face of the electrode base, of the ring piece.

4. The fixing device as claimed in claim 3, wherein the movable block is provided with a groove, and the groove penetrates through the end face of the movable seat.

5. The fixing device according to claim 4, wherein the fixing member is formed in a spiral shape, and the groove is a U-shaped groove or a V-shaped groove, and is inclined in a direction opposite to a rotation direction of the fixing member with respect to an end surface of the movable seat.

6. A fixing device according to claim 3, characterised in that said reducible member is interposed between said ring and said connecting tab, said movable seat being actuated by said elastic member, said connecting tab having a tendency to move closer to said ring.

7. The fixation device of claim 6, wherein the contractible member is a dissolvable member.

8. 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 shaft sleeve, the ring piece is sleeved on the shaft sleeve, and the fixing block is abutted against the rib, the connecting piece is sleeved on the shaft sleeve and located between the ring piece and the rib, an accommodating space surrounding the circumferential side of the shaft sleeve is formed between the connecting piece and the ring piece, and the dissolvable piece is located in the accommodating space.

9. The fixing device as claimed in claim 8, wherein the fixing block is provided with a liquid passing hole, the liquid passing hole is located on a side of the ring plate facing away from the end surface of the fixing seat, and when the rotation preventing member is in the first state, the liquid passing hole is communicated with the accommodating space.

10. The fixing device as claimed in claim 8, wherein the elastic member is a spring, and two ends of the spring respectively elastically abut against the connecting piece and the rib.

11. The fixing device as claimed in claim 10, wherein a side of the connecting plate facing away from the ring plate is provided with an annular blind groove, when the movable seat is mounted on the insulating base, the annular blind groove surrounds the outer periphery of the shaft sleeve, and one end of the spring is received and limited in the annular blind groove.

12. The fastening device of claim 11, wherein the tab abuts the rib when the anti-rotation assembly is in the first state, and wherein the entire structure of the spring is received in the annular blind groove.

13. A fixing device according to claim 3, wherein the inflatable member is arranged on a side of the connecting piece facing away from the ring piece, and the movable seat is driven by the elastic member, and the connecting piece has a moving tendency away from the ring piece.

14. The fixation device of claim 13, wherein the expandable member is a plurality of at least 2 of the plurality of expandable members being of different shape-changing materials.

15. The fixation device of claim 13, wherein the pacing system comprises an insulating base, the insulating base comprises a shaft sleeve and a rib surrounding the shaft sleeve, the connecting plate and the ring plate are sequentially sleeved on the shaft sleeve, and the expandable member is sandwiched between the connecting plate and the rib.

16. The fixing device of claim 15, wherein one side of the fixing seat far away from the end surface of the fixing seat abuts against the rib, a receiving space surrounding the circumferential side of the shaft sleeve is formed between the connecting piece and the rib, and the expandable member is located in the receiving space.

17. The fixing device as claimed in claim 16, wherein the expandable member is a liquid-absorbent deformable material, the fixing block is provided with a liquid passing hole, the liquid passing hole is located on a side of the ring plate facing away from the end surface of the fixing seat, and when the rotation preventing member is in the first state, the liquid passing hole is communicated with the accommodating space.

18. The fixing device as claimed in claim 17, wherein the connecting piece is provided with a through groove, and the liquid passing hole is communicated with the accommodating space through the through groove.

19. The fastening device of claim 18, wherein the expandable member defines a fluid-aspirating aperture in communication with the channel.

20. The fixing device according to claim 18, wherein the through slot includes an annular portion, the annular portion of the through slot surrounds an outer periphery of the bushing when the movable seat is mounted on the insulating base, the elastic member is a spring, one end of the spring is received in the annular portion of the through slot, and the other end of the spring abuts against the ring plate.

21. The securing device according to claim 20, wherein when the anti-rotation component is in the second state, the connecting tab abuts against the ring tab and the entire structure of the spring is received within the annular portion of the through slot.

22. The fastening device of claim 17, wherein the connecting tab abuts the ring tab and seals the fluid-passing bore when the anti-rotation component is in the second state.

23. A fixation device as claimed in claim 20, wherein the spring is located between the connecting web and the ring web.

24. The fastening device of claim 23, wherein at least one of the connecting tab and the ring has an annular recess for receiving the spring, the connecting tab abutting the ring when the anti-rotation assembly is in the second position.

25. The fixture according to claim 1, wherein when the rotation prevention assembly is in the second state, the end surface of the movable seat is flush with the end surface of the electrode base.

26. A pacing system comprising a fixation device according to any one of claims 1-25.