CN112546445A - Cardiac pacemaker shell structure and forming process thereof - Google Patents

Abstract

The invention discloses a cardiac pacemaker shell structure and a forming process thereof.A metal sealing shell component comprises an upper metal shell, a lower metal shell and a feed-through component; the upper ends of the side walls of the upper metal shell and the lower metal shell are respectively provided with an upper feed-through groove and a lower feed-through groove; the opening edge of the lower metal shell is simultaneously spun and formed with a full-profile special-shaped necking at the inner side and the outer side of the same position of the lower metal shell by using a rotary supporting wheel and a rotary pressing wheel; the inner contour of the upper metal shell is buckled on the full-contour special-shaped necking, and is welded with the lower metal shell through laser to form a cavity for accommodating an internal electronic component; the feed-through assembly is continuously welded with the upper metal shell and the lower metal shell through laser to form a closed cavity; the invention reduces the number of parts, simplifies the assembly process, reduces corresponding dies, tool fixtures and processing equipment, reduces the product cost, and simultaneously improves the assembly property and the qualification rate of finished products.

Description

Cardiac pacemaker shell structure and forming process thereof

Technical Field

The invention relates to the technical field of medical instruments, in particular to a cardiac pacemaker shell structure and a forming process thereof.

Background

Currently, implantable medical devices are widely used to treat neurological and cardiac disorders.

An implantable cardiac pacemaker is an electronic therapeutic apparatus implanted in a patient for a long time, an electric pulse provided with energy by a battery is delivered by a pulse generator, and the electric pulse is conducted by a lead electrode to stimulate cardiac muscle contacted by the electrode so as to excite and contract the heart, thereby achieving the purpose of treating the cardiac dysfunction caused by certain arrhythmia.

The hardware of the pulse generator part of the cardiac pacemaker is mainly composed of a battery, a circuit module, a metal sealing shell, a high polymer material top cover containing an electrode connector and the like. Wherein the circuit connection between the circuit in the metal sealed shell and the electric appliance of the high polymer material top cover containing the electrode connector is completed by the feed-through assembly and the metal connecting wire.

The metal sealing shell component of the cardiac pacemaker is used as an active medical apparatus product implanted into a human body for a long time, is used for supporting the life of a patient, has extremely high requirements on the sealing protection of an internal circuit, needs to be detected by a helium mass spectrometer leak detector, and has a leak rate of less than 10 < -8 >Pa x m 3/S. The shell of the metal sealing shell component of the existing cardiac pacemaker is composed of two separated opening shells made of metal, and after the opening shells assemble functional modules such as electronic components, chips, batteries, board cards and communication coils inside, the two shells and feed-through are welded together in a laser welding mode, so that the requirement that two metal shells are perfectly matched in the welding process is met, and no pore exists.

Because the laser welding temperature is very high, and electronic components, chips, batteries, board cards, communication coils and the like in the metal sealing shell component can not resist the high temperature generated in the laser welding process, an isolation structure is required to be designed between the two metal shells to prevent the high temperature from being conducted to the inside. Meanwhile, the laser has strong penetrating power, if the laser penetrates through the joint gap of the two metal shells in the welding process and irradiates the functional module, the reliability of the internal functional module can be influenced or even damaged, the safety of a finished pacemaker product is influenced, and therefore the structure for preventing the laser from penetrating through the gap needs to be designed inside the two metal shells. The insulating temperature and penetration preventing structure is referred to as an insulating band for short. This heat insulating belt is except protecting inside components and parts not destroyed, still when two metal casing assembles, plays support and fixed inside function module, guarantees two metal casing's location, because of two metal casing produce the bad effect of welding that dislocation, height offset etc. lead to during the prevention laser welding.

The prior art typically designs the insulating strips as separate metal parts. This thermal-insulated area requires the production of mould of high accuracy, and the finished product size is accurate, and requires higher to the mould. Secondly, before two metal casing encapsulation welding, need weld heat insulating tape to one of them metal casing on, and guarantee that heat insulating tape can laminate at the metal casing internal surface uniformly to guarantee the equipment and the thermal-insulated effect of follow-up inside function module. Because the heat insulation belt is a profiling narrow belt, the process needs to be shaped and accurately positioned through a tool clamp, and the process development difficulty is high. Because the heat insulation belt and the metal shell are difficult to position in the welding process, poor welding is easy to cause, and the rejection rate is increased.

Because the whole profile of the special-shaped full-profile necking piece is of a necking structure, the special-shaped full-profile necking piece needs to be supported by the internal full profile during stamping, so that the special-shaped full-profile necking piece can not deform during stamping forming, and the size precision of the special-shaped full-profile necking piece is ensured. If full profile support is used, this can result in some of the forming cores of the press die not being able to exit the draw.

The spinning process is a relatively mature metal forming process. In the rotation of the blank with the die or the rotation of the spinning tool around the blank, the spinning tool is fed against the blank, thereby pressing and producing a continuous, point-by-point deformation of the blank. The use of spinning techniques has become very common due to the simplicity of the equipment and the dies. However, because of the limitation of the motion mode of the spinning process, the application of the spinning process only aims at the processing of some revolving body metal parts, and the full-profile special-shaped structural parts are rarely processed.

Patent publication No. CN 241139 discloses a pulse generator device, including pulse generator functional circuit, insulator, outer lead wire, interior pin end, half shell on the left side, half shell on the right side. The manufacturing method comprises the steps of buckling the left titanium shell and the right titanium shell, sewing and welding a seam between the two half shells and the insulator by adopting a program-controlled thinking linkage control system and a laser welding system, so that the two half shells and the insulator are firmly connected into a whole, sealing is guaranteed, and an outer lead is spot-welded. No specific solder package positioning problem or solution is mentioned.

Disclosure of Invention

The invention aims to provide a novel metal shell structure of a heart pacemaker adopting a spinning-formed full-profile special-shaped necking and a process thereof, which cancel heat insulation belt parts to reduce the assembly parts of a heart pacemaker pulse generator shell, simplify the assembly process of the heart pacemaker, reduce the types of a mould and a tool clamp, improve the welding yield and improve the reliability and the safety of a product.

The invention is realized by the following technical scheme:

a cardiac pacemaker housing structure comprising a metal sealed housing component, wherein: the metal seal housing assembly includes an upper metal housing, a lower metal housing, and a feedthrough assembly; the upper ends of the side walls of the upper metal shell and the lower metal shell are respectively provided with an upper feed-through groove and a lower feed-through groove for placing the feed-through assembly; the edge of the opening of the lower metal shell is provided with a full-profile special-shaped necking in a spinning mode; the inner contour of the upper metal shell is buckled on the full-contour special-shaped necking, and is welded with the lower metal shell through laser to form a cavity for accommodating an internal electronic component; and the feed-through assembly is continuously welded with the upper metal shell and the lower metal shell through laser to form a closed cavity.

Further, the feedthrough assembly is a kidney-round feedthrough assembly; the kidney-shaped feed-through assembly comprises a kidney-shaped feed-through flange edge, a feed-through metal wire and a kidney-shaped feed-through ceramic; the waist-shaped feed-through flange edge is arranged at one end of the waist-shaped feed-through ceramic; the waist-round feed-through flange edge is continuously welded with the outer side wall of the upper metal shell and the outer side wall of the lower metal shell through laser to form a closed cavity; one end of the feed-through metal wire penetrates through the edge of the waist-shaped feed-through flange to be connected with the waist-shaped feed-through ceramic; the feed-through metal wire is used for connecting the circuit in the metal sealed shell of the cardiac pacemaker and the circuit of the electrode connector in the high polymer material top cover.

Further, the feedthrough assembly is a circular feedthrough assembly; the circular feedthrough assembly comprises a circular feedthrough flange rim, a feedthrough wire, and a circular feedthrough ceramic; the circular feed-through flange edge is arranged at one end of the circular feed-through ceramic; the circular feed-through flange edge is continuously welded with the outer side wall of the upper metal shell and the outer side wall of the lower metal shell through laser to form a closed cavity; one end of the feed-through metal wire penetrates through the edge of the circular feed-through flange to be connected with the circular feed-through ceramic; the feed-through metal wire is used for connecting the circuit in the metal sealed shell of the cardiac pacemaker and the circuit of the electrode connector in the high polymer material top cover.

Further, the retraction distances of the full-profile special-shaped necking are equal.

Further, the upper feed-through groove and the lower feed-through groove are both in a shape of a half waist circle.

Further, the upper feedthrough through slot and the lower feedthrough through slot are both semi-circular in shape.

Further, the waist-shaped feed-through ceramic and the circular feed-through ceramic are both insulating filling materials; the metal sealing shell component is made of pure titanium or titanium alloy materials.

Further, the molding process of the cardiac pacemaker housing structure comprises the following steps:

s1, applying rotary pressure by the aid of a spinning wheel to abut against the outer contour of the lower metal shell, and enabling the opening structure of the lower metal shell to contract inwards; the supporting wheel is abutted against the inner part of the lower metal shell to rotate, and simultaneously plays a supporting role, so that the lower metal shell is prevented from deforming in the process of being pressed by the spinning wheel;

s2, the supporting wheel and the spinning wheel respectively rotate at the inner side and the outer side of the same position of the lower metal shell; the motion trails of the supporting wheel and the spinning wheel are the outer contour lines of the lower metal shell;

s3, the relative distance between the supporting wheel and the spinning wheel is the wall thickness of the lower metal shell; the full-profile special-shaped necking is formed on the edge of the opening of the lower metal shell in a rotary forming mode through the interaction of the rotary pressing wheel and the supporting wheel.

Further, in the step S2, the rotation directions of the supporting wheels and the lower metal shell are the same, and both are counterclockwise; the rotating direction of the spinning wheel is opposite to that of the lower metal shell and the supporting wheel, and the spinning wheel is clockwise.

Further, in step S1, before the lower metal shell is formed by spinning, the lower metal shell is cleaned and sterilized after the processes of blanking, stamping, spinning, annealing, shaping, punching, etc. for use in the next process.

The invention has the beneficial effects that:

1. the full-profile special-shaped necking structure of the lower metal shell can replace a heat insulation belt in the prior art to play a role in heat insulation and isolation protection, and the situation that laser beams directly penetrate through metal sheets to damage internal components is effectively avoided.

2. The inner contour surface of the full-contour special-shaped necking structure of the lower metal shell has the functions of supporting and positioning internal parts; the outer contour surface of the full-contour special-shaped necking structure of the lower metal shell has the functions of supporting and positioning the upper metal shell.

3. Through setting up full profile abnormal shape throat, the condition that bad welding appears when can thoroughly avoid prior art mesophragma tropical and lower metal casing welding.

4. Compared with the prior art, the integrated full-profile special-shaped necking structure has stronger structural strength, and the assembling reliability of the upper metal shell and the lower metal shell is improved.

5. Compared with the prior art, the integrated full-profile special-shaped necking structure has higher dimensional stability and dimensional precision compared with the assembly and welding of two parts.

6. Compared with the prior art, the integrated full-profile special-shaped necking structure reduces the number of parts, simplifies the assembly process, reduces corresponding dies, tool fixtures and processing equipment, reduces the product cost, and simultaneously improves the assembly property and the finished product qualification rate of the product.

Drawings

FIG. 1 is a perspective view of a 3D structure of a metallic pacemaker of a prior art arrangement;

FIG. 2 is a view of the prior art for welding and assembling a metal shell and a heat insulating strip;

FIG. 3 is a schematic illustration of laser welding of a metal housing of a prior art cardiac pacemaker;

FIG. 4 is a perspective view of the 3D structure of the metal housing of the pacemaker of the present invention;

FIG. 5 is a schematic cross-sectional view of a laser welding structure of a metal shell of the cardiac pacemaker according to the present invention;

FIG. 6 is a schematic diagram of an assembled pacemaker pulse generator according to a first embodiment of the present invention;

FIG. 7 is a feedthrough assembly of a first embodiment of the present disclosure;

FIG. 8 is a schematic diagram of an assembled pacemaker pulse generator according to a second embodiment of the present invention;

FIG. 9 is a feedthrough assembly of a second embodiment of the present disclosure;

FIG. 10 is a top plan view of the lower metal shell spin-forming of the present invention;

FIG. 11 is a side view of the spin forming of the lower metal shell of the present invention.

Description of reference numerals: 1-prior art upper metal shell; 101-prior art upper metal shell feedthrough via; 2-prior art lower metal shell; 201-lower metal shell feedthrough via of the prior art; 3-prior art thermal insulation tape; 301-insulating tape feedthrough via of the prior art; 4-prior art lower metal shell assembly; 5-the upper metal shell of the invention; 501-upper feed-through via of the invention; 502-upper metal shell inner profile of the invention; 6-the lower metal shell of the invention; 601-lower feed-through of the invention through the slot; 602-full profile, profiled, necking down inner profile of the present invention; 603-the full-profile special-shaped necking outer profile of the invention; 7-the feedthrough assembly of the first embodiment; 701-the feed-through flange edge of the first embodiment; 702-the feed-through wire of the first embodiment; 703 — the feed-through ceramic of the first embodiment; 8-the feedthrough assembly of the second embodiment; 801-feed-through flange edge of second embodiment; 802-the feed-through wire of the second embodiment; 803 — the feed-through ceramic of the second embodiment; 9-a support wheel; 10-spinning wheel; 911-support wheel rotation direction; 111-rotating direction of the spinning wheel; 611-direction of rotation of the lower metal shell.

Detailed Description

The invention will be described in detail with reference to the drawings and specific embodiments, which are illustrative of the invention and are not to be construed as limiting the invention.

It should be noted that all the directional indications (such as up, down, left, right, front, back, upper end, lower end, top, bottom … …) in the embodiments of the present invention are only used to explain the relative position relationship between the components, the movement situation, etc. in a specific posture (as shown in the drawings), and if the specific posture is changed, the directional indication is changed accordingly.

In the present invention, unless expressly stated or limited otherwise, the term "coupled" is to be interpreted broadly, e.g., "coupled" may be fixedly coupled, detachably coupled, or integrally formed; can be mechanically or electrically connected; they may be directly connected or indirectly connected through intervening media, or they may be connected internally or in any other suitable relationship, unless expressly stated otherwise. The specific meanings of the above terms in the present invention can be understood by those skilled in the art according to specific situations.

In addition, the descriptions related to "first", "second", etc. in the present invention are only for descriptive purposes and are not to be construed as indicating or implying relative importance or implicitly indicating the number of technical features indicated. Thus, a feature defined as "first" or "second" may explicitly or implicitly include at least one such feature; in addition, technical solutions between various embodiments may be combined with each other, but must be realized by a person skilled in the art, and when the technical solutions are contradictory or cannot be realized, such a combination should not be considered to exist, and is not within the protection scope of the present invention.

Referring to fig. 1, 3 and 7, a prior art embodiment is shown, which includes a prior artupper metal shell 1, a prior artlower metal shell 2, a priorart insulating strip 3, and a prior art insulating strip feed-through assembly.

As shown in fig. 2, a prior art lowermetal shell assembly 4 is constructed by spot welding aheat insulating tape 3 to the inner wall of alower metal shell 2 according to the contour thereof in an embodiment of the prior art.

In a specific embodiment of the prior art, the internal electronic components are sequentially assembled into the lowermetal shell assembly 4 of the prior art, and then welded together with themetal shell 1 and the feed-throughassembly 7 in a welding manner to form a sealed whole. And (4) carrying out leak detection by helium mass spectrometry and then putting into the next working procedure.

The feed-through of the prior art may be in the form of the feed-throughassembly 7 of the first embodiment, the feed-throughassembly 8 of the second embodiment, or other forms of feed-through assemblies.

In one embodiment of the prior art, theheat insulation belt 3 is a profiling narrow belt, so that precise die forming and shaping are required, and the development cost is high. Simultaneously thermal-insulated 3 have thermal-insulated simultaneously, fix a position and prevent that laser from piercing through the effect in gap, so this process need use the accurate location of frock clamp. The process has high development difficulty. Because the heat insulation belt and the metal shell are difficult to position in the welding process, poor welding is easy to cause, and the rejection rate is increased.

As shown in fig. 4 to 9, a cardiac pacemaker housing structure comprising a metal sealed housing assembly, wherein: the metal-sealed housing assembly comprises anupper metal housing 5, alower metal housing 6 and a feed-throughassembly 7 or 8; the upper end of the side wall of theupper metal shell 5 and the upper end of the side wall of thelower metal shell 6 are respectively provided with an upper feed-throughgroove 501 and a lower feed-throughgroove 601 for placing the feed-throughassembly 7 or the feed-throughassembly 8; the edge of the opening of thelower metal shell 6 is formed with a full-profile special-shaped necking in a spinning way; the inner contour of theupper metal shell 5 is buckled on the full-contour special-shaped necking, and is welded with thelower metal shell 6 through laser to form a cavity for accommodating internal electronic components; the feed-throughassembly 7 or the feed-throughassembly 8 is continuously welded with theupper metal shell 5 and thelower metal shell 6 respectively through laser to form a closed cavity;

the metal shell structure component provided by the invention comprises anupper metal shell 5, alower metal shell 6 with a full-contour special-shaped necking structure and a feed-throughcomponent 7 or a feed-throughcomponent 8.

The necking structure of thelower metal shell 6 replaces the function of a heat insulation belt in the prior art, the full-profile special-shaped neckingouter profile 603 of thelower metal shell 6 has the functions of heat insulation and laser penetration resistance, and can be perfectly matched with the upper metal shellinner profile 502 to realize the precise positioning and assembly of theupper metal shell 5 and thelower metal shell 6.

It should be noted that the full-profile shapedinner contour 602 also has the function of supporting and protecting internal components.

Specifically, in the embodiment, the necking of thelower metal shell 6 and the outer contour of thelower metal shell 6 are in an integral equidistant inward shrinkage structure, and are formed in a spinning mode without additional shaping, and the position accuracy is accurate.

First embodiment, as shown in fig. 7, thefeedthrough assembly 7 of the first embodiment is a kidney-shaped one, and is composed of afeedthrough flange 701 of the first embodiment, afeedthrough wire 702 of the first embodiment, and afeedthrough ceramic 703 of the first embodiment.

Specifically, in this embodiment, the feed-throughflange 701 of the first embodiment is made of metal, and is continuously welded to theupper metal housing 5 and thelower metal housing 6 by laser to form a sealed cavity.

Specifically, in this embodiment, the first embodiment of the feed-throughwire 702 on the first embodiment of the feed-throughassembly 7 interconnects the circuitry inside the metal sealed housing of the cardiac pacemaker and the circuitry of the electrode connector inside the polymer material cap, thereby forming the electrical connection part of the complete cardiac pacemaker pulse generator.

Specifically, in this embodiment, the feed-throughceramic 703 of the first embodiment in the feed-throughassembly 7 of the first embodiment is an insulating filler material.

Second embodiment, as shown in fig. 9, thefeedthrough assembly 8 of the second embodiment is circular and is composed of afeedthrough flange 801 of the second embodiment, afeedthrough wire 802 of the second embodiment, and afeedthrough ceramic 803 of the second embodiment.

Specifically, in the present embodiment, the feed-throughflange 801 of the second embodiment is made of metal, and is continuously welded to theupper metal housing 5 and thelower metal housing 6 by laser to form a sealed cavity.

Specifically, in this embodiment, the secondembodiment feedthrough assembly 8 of the second embodiment.

Specifically, in this embodiment, the second embodiment of thefeedthrough assembly 8 of the second embodiment of the present invention has thefeedthrough ceramic 803 of the second embodiment as an insulating filler material.

The necking of thelower metal shell 6 is of a full-profile special-shaped necking structure, the necking retraction distances are equal, theupper metal shell 5 can be supported in a full profile and accurately positioned, and poor welding caused by dislocation of the two metal shells is prevented.

In this embodiment, the process of making the metal seal housing assembly is: the internal electronic components are assembled into thelower metal shell 6 in sequence, and the internal electronic components of the metal sealing shell assembly can be well positioned due to the fact that theinner contour 602 of the retraction structure of thelower metal shell 6 is matched with the internal components in contour.

Specifically, in this embodiment, theinner contour 502 of the upper metal shell is buckled on theouter contour 603 of the retracted structure of the lower metal shell. At this time, the full-profile special-shaped neckingouter profile 603 of thelower metal shell 6 is perfectly matched with the upper metal shellinner profile 502, so that theupper metal shell 5 can be well fixed, the position degree of the upper metal shell is ensured, the dislocation and the height offset are prevented, and the welding yield between theupper metal shell 5 and thelower metal shell 6 is ensured.

Since thethermal insulation band 3 of the prior art and thelower metal shell 2 of the prior art are made into an integral structure in a necking form, i.e., thelower metal shell 6 of the present invention, the positioning, assembling and welding processes of thethermal insulation band 3 of the prior art and thelower metal shell 2 of the prior art are reduced. The purposes of spot welding theheat insulation belt 3 in the prior art and thelower metal shell 2 in the prior art and then positioning, assembling and welding the lowermetal shell assembly 4 in the prior art, themetal shell 1 and the feed-throughassembly 7 can be achieved only by positioning, assembling and welding theupper metal shell 5 and thelower metal shell 6 in the prior art once.

Thelower metal shell 6 is an improvement of the prior art, and theheat insulation belt 3 in the prior art and thelower metal shell 2 in the prior art are condensed into one part, so that the number of parts is reduced, and a manufacturing die of theheat insulation belt 3 is saved; the welding times are reduced; the number of tool fixtures used for welding is reduced; the problem of poor welding of the prior artheat insulating strip 3 and the prior artlower metal shell 2 is completely avoided.

As shown in fig. 10 to 11, thelower metal shell 6 is formed by a spinning process to form a full-profile necking structure of thelower metal shell 6, and it should be noted that a contour line of the full-profile necking structure is a non-revolving body profile structure.

The motion trail of thelower metal shell 6 in the spinning process is the outer contour line of thelower metal shell 6.

Thespinning wheel 10 applies a spinning pressure on the outer contour line of thelower metal shell 6 to retract the opening structure of thelower metal shell 6.

The supportingwheel 9 plays a supporting role when rotating in thelower metal shell 6 in the spinning forming process, and thelower metal shell 6 is prevented from deforming in the process of being pressed by thespinning wheel 10.

The supportingwheel 9 and thespinning wheel 10 respectively rotate at the inner side and the outer side of the same position of thelower metal shell 6.

Specifically, in the embodiment, the relative distance between the supportingwheel 9 and thespinning wheel 10 is the wall thickness of thelower metal shell 6.

Specifically, in the embodiment, the rotation directions of the supportingwheel 9 in thelower metal shell 6 and thelower metal shell 6 are the same, and both therotation direction 611 of the lower metal shell and therotation direction 911 of the supporting wheel are counterclockwise. The rotating direction of thespinning wheel 10 outside thelower metal shell 6 is opposite to the rotating direction of thelower metal shell 6 and the supportingwheel 9, and therotating direction 111 of the spinning wheel is clockwise.

It should be noted that the rotation direction in this embodiment is only a preferred embodiment of the present invention, and the rotation direction is not necessarily the only direction in the actual spinning process.

The manufacturing method of thelower metal shell 6 adopts the working procedures of blanking, stamping, spinning, annealing, shaping, punching and the like, and then cleaning and sterilizing are carried out for the next working procedure.

The invention has the advantages of simple structure, convenient processing, stable performance, complete functions and convenient operation.

In this embodiment, the necking structure of thelower metal shell 6 may be formed by a spinning process, or may be formed by other processes.

The metal shell material provided by the invention can be pure titanium or titanium alloy.

The metal shell structure provided by the invention is suitable for, but not limited to, an implanted cardiac pacemaker, an Implanted Cardioverter Defibrillator (ICD), a cardiac resynchronization therapy defibrillator (CRT-D), a cardiac resynchronization therapy pacemaker (CRT-P), an implanted brain pacemaker, an implanted nerve stimulator, an implanted spinal cord stimulator, an implanted sacral nerve stimulator, an implanted vagus nerve stimulator and the like.

According to the invention, by designing the novel metal shell structure of the integrated full-profile special-shaped necking cardiac pacemaker formed by spinning and the process thereof, heat insulation belt parts are eliminated to reduce the number of assembly parts of the cardiac pacemaker pulse generator shell, the assembly process of the cardiac pacemaker is simplified, the types of dies and tool fixtures are reduced, the welding yield is improved, and the reliability and the safety of the product are improved.

The technical solutions provided by the embodiments of the present invention are described in detail above, and the principles and embodiments of the present invention are explained herein by using specific examples, and the descriptions of the embodiments are only used to help understanding the principles of the embodiments of the present invention; meanwhile, for a person skilled in the art, according to the embodiments of the present invention, there may be variations in the specific implementation manners and application ranges, and in summary, the content of the present description should not be construed as a limitation to the present invention.

Claims (10)

Translated fromChinese

1.一种心脏起搏器外壳结构，包括金属密封外壳组件，其特征在于：所述金属密封外壳组件包括上金属外壳、下金属外壳和馈通组件；所述上金属外壳和所述下金属外壳的侧壁上端分别设置有用于放置所述馈通组件的上馈通过槽和下馈通过槽；所述下金属外壳开口边缘旋压成型有全轮廓异型缩口；所述上金属外壳的内轮廓扣合在所述全轮廓异型缩口上，并通过激光与所述下金属外壳焊接构成容纳内部电子元器件的腔体；所述馈通组件分别与所述上金属外壳和所述下金属外壳通过激光连续焊接成为密闭的腔体。1. A cardiac pacemaker housing structure, comprising a metal sealing housing assembly, characterized in that: the metal sealing housing assembly comprises an upper metal housing, a lower metal housing and a feed-through assembly; the upper metal housing and the lower metal housing The upper end of the side wall of the casing is respectively provided with an upper feed-through slot and a lower feed-through slot for placing the feed-through assembly; the opening edge of the lower metal casing is spin-formed with a full-profile special-shaped constriction; the inner part of the upper metal casing The contour is fastened on the full contour special-shaped constriction, and is welded with the lower metal shell by laser to form a cavity for accommodating internal electronic components; the feed-through assembly is respectively connected with the upper metal shell and the lower metal shell It becomes a closed cavity by continuous laser welding.2.根据权利要求1所述的一种心脏起搏器外壳结构，其特征在于：所述馈通组件为腰圆形馈通组件；所述腰圆形馈通组件包括腰圆形馈通法兰边、馈通金属丝和腰圆形馈通陶瓷；所述腰圆形馈通法兰边设置于所述腰圆形馈通陶瓷的一端；所述腰圆形馈通法兰边分别与所述上金属外壳的外侧壁和所述下金属外壳外侧壁通过激光连续焊接成为密闭的腔体；所述馈通金属丝一端穿过所述腰圆形馈通法兰边与所述腰圆形馈通陶瓷连接；所述馈通金属丝用于将心脏起搏器金属密封外壳内的电路与高分子材料顶盖内的电极连接器的电路相互连接。2 . The pacemaker housing structure according to claim 1 , wherein the feed-through assembly is a waist-circle feed-through assembly; the waist-circle feed-through assembly comprises a waist-circle feed-through method. 3 . A flange, a feed-through wire and a waist-circular feed-through ceramic; the waist-circular feed-through flange is arranged at one end of the waist-circular feed-through ceramic; the waist-circular feed-through flange is respectively connected to the The outer side wall of the upper metal shell and the outer side wall of the lower metal shell are continuously welded by laser to form a closed cavity; one end of the feed-through wire passes through the waist circle feed-through flange and the waist circle Shape feedthrough ceramic connection; the feedthrough wire is used to interconnect the circuit in the metal sealed casing of the pacemaker and the circuit of the electrode connector in the polymer material top cover.3.根据权利要求2所述的一种心脏起搏器外壳结构，其特征在于：所述馈通组件为圆形馈通组件；所述圆形馈通组件包括圆形馈通法兰边、馈通金属丝和圆形馈通陶瓷；所述圆形馈通法兰边设置于所述圆形馈通陶瓷的一端；所述圆形馈通法兰边分别与所述上金属外壳的外侧壁和所述下金属外壳外侧壁通过激光连续焊接成为密闭的腔体；所述馈通金属丝一端穿过所述圆形馈通法兰边与所述圆形馈通陶瓷连接；所述馈通金属丝用于将心脏起搏器金属密封外壳内的电路与高分子材料顶盖内的电极连接器的电路相互连接。3 . The pacemaker housing structure according to claim 2 , wherein: the feed-through assembly is a circular feed-through assembly; the circular feed-through assembly comprises a circular feed-through flange, Feed-through wire and circular feed-through ceramic; the circular feed-through flange is arranged at one end of the circular feed-through ceramic; the circular feed-through flange is respectively connected to the outer side of the upper metal shell The wall and the outer side wall of the lower metal shell are continuously welded by laser to form a closed cavity; one end of the feed-through wire is connected to the circular feed-through ceramic through the circular feed-through flange; The metal wire is used to connect the circuit in the metal sealed shell of the cardiac pacemaker with the circuit of the electrode connector in the polymer material top cover.4.根据权利要求1所述的一种心脏起搏器外壳结构，其特征在于：所述全轮廓异型缩口的内缩距离相等。4 . The pacemaker housing structure according to claim 1 , wherein the retraction distances of the full-contour special-shaped constriction are equal. 5 .5.根据权利要求2所述的一种心脏起搏器外壳结构，其特征在于：所述上馈通过槽和所述下馈通过槽的形状均为半腰圆形。5 . The pacemaker housing structure according to claim 2 , wherein the upward feed-through slot and the downward feed-through slot are both semi-waist circular in shape. 6 .6.根据权利要求3所述的一种心脏起搏器外壳结构，其特征在于：所述上馈通过槽和所述下馈通过槽的形状均为半圆形。6 . The pacemaker housing structure according to claim 3 , wherein the upward feed-through slot and the downward feed-through slot are both semicircular in shape. 7 .7.根据权利要求3所述的一种心脏起搏器外壳结构，其特征在于：所述腰圆形馈通陶瓷和所述圆形馈通陶瓷均为绝缘填充材料；所述金属密封外壳组件采用纯钛或钛合金材料制作而成。7 . The pacemaker housing structure according to claim 3 , wherein the waist circular feed-through ceramic and the circular feed-through ceramic are both insulating filling materials; the metal-sealed housing component Made of pure titanium or titanium alloy material.8.一种心脏起搏器外壳结构的成型工艺，其特征在于，包括以下步骤：8. a molding process of a cardiac pacemaker shell structure, is characterized in that, comprises the following steps:S1，采用旋压轮抵靠在下金属外壳的外轮廓上施加旋转压力，使下金属外壳的开口结构内缩；采用支撑轮抵靠在下金属外壳内部旋转时同时起到支撑作用，避免下金属外壳在被旋压轮施压的过程中变形；S1, the spinning wheel is used to press against the outer contour of the lower metal shell to apply rotational pressure to shrink the opening structure of the lower metal shell; the supporting wheel is used to rotate against the inner part of the lower metal shell and simultaneously play a supporting role to avoid the lower metal shell. Deformed in the process of being pressed by the spinning wheel;S2，支撑轮和旋压轮分别在下金属外壳的同一位置的内外两侧同时做旋转运动；支撑轮和旋压轮运动轨迹为下金属外壳的外轮廓线；S2, the supporting wheel and the spinning wheel perform rotational motions at the same time on the inner and outer sides of the same position of the lower metal shell respectively; the movement trajectory of the supporting wheel and the spinning wheel is the outer contour of the lower metal shell;S3，支撑轮和旋压轮的相对距离为下金属外壳的壁厚；通过旋压轮与支撑轮的相互作用在下金属外壳开口边缘上旋压成型全轮廓异型缩口。S3, the relative distance between the support wheel and the spinning wheel is the wall thickness of the lower metal shell; through the interaction between the spinning wheel and the support wheel, a full-profile special-shaped constriction is formed by spinning on the opening edge of the lower metal shell.9.根据权利要求8所述的一种心脏起搏器外壳结构的成型工艺，其特征在于：在所述步骤S2中，支撑轮与下金属外壳的旋转方向一致，均为逆时针方向；旋压轮则与下金属外壳和支撑轮的旋转方向相反，为顺时针方向。9. The forming process of a cardiac pacemaker shell structure according to claim 8, characterized in that: in the step S2, the rotation directions of the support wheel and the lower metal shell are consistent, and both are counterclockwise; The rotation direction of the pressing wheel is opposite to the rotation direction of the lower metal shell and the supporting wheel, which is clockwise.10.根据权利要求8所述的一种心脏起搏器外壳结构的成型工艺，其特征在于：在所述步骤S1中，下金属外壳在旋压成型前，下金属外壳先通过落料、冲压、旋压、退火，整形、打孔等工序后，清洗消毒以备下一道工序使用。10 . The forming process of a cardiac pacemaker shell structure according to claim 8 , wherein in the step S1 , before the lower metal shell is formed by spinning, the lower metal shell is blanked and punched first. 11 . , spinning, annealing, shaping, drilling and other processes, cleaning and disinfection to prepare for the next process.

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