A cardiac pacemaker housing structure and its forming process

Abstract

The invention discloses a cardiac pacemaker housing structure and a molding process thereof. The metal sealed housing assembly comprises an upper metal housing, a lower metal housing and a feed-through assembly. The upper ends of the side walls of the upper metal housing and the lower metal housing are respectively provided with an upper feed-through groove and a lower feed-through groove. The opening edge of the lower metal housing is simultaneously spin-formed with a full-contour special-shaped shrinkage on both inner and outer sides of the same position of the lower metal housing by using a rotating support wheel and a rotating pressure wheel. The inner contour of the upper metal housing is buckled on the full-contour special-shaped shrinkage, and is laser welded with the lower metal housing to form a cavity for accommodating internal electronic components. The feed-through assembly is respectively laser-continuously welded with the upper metal housing and the lower metal housing to form a closed cavity. The invention reduces the number of parts, simplifies the assembly process, reduces the corresponding molds, fixtures, and processing equipment, reduces product costs, and improves the assemblability and finished product qualification rate of the product.

Description

Technical Field

[0001] The invention relates to the technical field of medical devices, in particular to a cardiac pacemaker housing structure and a molding process thereof. Background Art

[0002] Currently, implantable medical devices are widely used to treat diseases of the nervous system and cardiac system.

[0003] An implantable cardiac pacemaker is an electronic therapeutic device that is implanted in the patient's body for a long time. It emits electrical pulses powered by a battery through a pulse generator, which are conducted through wire electrodes to stimulate the myocardium that the electrodes contact, causing the heart to become excited and contracted, thereby achieving the purpose of treating heart dysfunction caused by certain arrhythmias.

[0004] The hardware of the pulse generator of the cardiac pacemaker is mainly composed of components such as batteries, circuit modules, metal sealed shells and polymer material top covers containing electrode connectors. The circuit connection between the circuit in the metal sealed shell and the electrical connection of the polymer material top cover containing the electrode connector is completed by feed-through components and metal connecting wires.

[0005] As an active medical device product implanted in the human body for a long time to support the life of the patient, the metal sealed housing assembly of the pacemaker has extremely high requirements for sealing protection of its internal circuit. It needs to be tested by a helium mass spectrometer leak detector with a leakage rate of less than 10-8Pa*m3 / S. The housing of the existing metal sealed housing assembly of the pacemaker is composed of two separate open shells made of metal. After the electronic components, chips, batteries, boards, communication coils and other functional modules are assembled into the open shell, the two shells and feedthroughs are welded together by laser welding. This requires that the two metal shells are perfectly matched during the welding process without any pores.

[0006] Since the laser welding temperature is very high, and the electronic components, chips, batteries, boards, communication coils, etc. in the metal sealed shell assembly cannot withstand the high temperature generated during the laser welding process, an isolation structure needs to be designed between the two metal shells to prevent the high temperature from being conducted to the inside. At the same time, the laser has a strong penetrating ability. If the laser penetrates the joint gap between the two metal shells during the welding process and irradiates the functional module, it will affect or even destroy the reliability of the internal functional module and affect the safety of the finished pacemaker. Therefore, a structure to prevent the laser from penetrating the gap needs to be designed inside the two metal shells. The isolation temperature and anti-penetration structure are referred to as insulation belts. In addition to protecting the internal components from damage, the insulation belt also supports and fixes the internal functional modules when the two metal shells are assembled, ensures the positioning of the two metal shells, and prevents poor welding caused by misalignment and height difference between the two metal shells during laser welding.

[0007] In the prior art, the insulation belt is generally designed as a separate metal part. The insulation belt requires high-precision mold production, and the finished product size is accurate, which places high demands on the mold. Secondly, before the two metal shells are packaged and welded, the insulation belt needs to be welded to one of the metal shells first, and it is ensured that the insulation belt can be evenly attached to the inner surface of the metal shell to ensure the subsequent assembly and insulation effect of the internal functional modules. Since the insulation belt is a contoured narrow belt, this process needs to be shaped and precisely positioned by a fixture, and the process development is difficult. Since it is difficult to position the insulation belt and the metal shell during welding, it is easy to cause poor welding, resulting in an increased scrap rate.

[0008] Since the full contour of the special-shaped full-contour shrinking parts is a shrinking structure, internal full-contour support is required during stamping, so that it will not deform during stamping and ensure its dimensional precision. If full-contour support is used, part of the forming core of the stamping die will not be able to exit from the shrinking.

[0009] Spinning is a relatively mature metal forming process. When the blank rotates with the mold or the spinning tool rotates around the blank, the spinning tool and the blank are fed relative to each other, so that the blank is compressed and deformed continuously and point by point. Due to the simplicity of equipment and molds, the application of spinning technology has been very common. However, due to the limitations of the movement mode of spinning process, the application of spinning process is generally only for the processing of some rotating metal parts, and rarely for processing full-contour special-shaped structural parts.

[0010] The utility model patent with patent announcement number CN2451139 discloses a pulse generator device, including a pulse generator functional circuit, an insulator, an external lead, an internal lead end, a left half shell, and a right half shell. The manufacturing method is to buckle the left and right titanium shells together, and use a program-controlled thinking linkage control system and a laser welding system to sew and weld the seams of the two half shells and the seams of the two half shells and the insulators to firmly connect them as one and ensure sealing, and spot weld the external lead at the same time. The specific welding package positioning problem and solution are not mentioned. Summary of the invention

[0011] The purpose of the present invention is to provide a novel metal shell structure of a pacemaker with full-contour special-shaped shrinkage formed by spin forming and its process, which eliminates the insulation belt parts to reduce the assembly parts of the pacemaker pulse generator shell, simplifies the assembly process of the pacemaker, reduces the types of molds and tooling fixtures, improves the welding yield, and improves the reliability and safety of the product.

[0012] The present invention is achieved through the following technical solutions:

[0013] A cardiac pacemaker housing structure comprises a metal sealed housing assembly, wherein: the metal sealed housing assembly comprises an upper metal housing, a lower metal housing and a feedthrough assembly; the upper ends of the side walls of the upper metal housing and the lower metal housing are respectively provided with an upper feedthrough groove and a lower feedthrough groove for accommodating the feedthrough assembly; the opening edge of the lower metal housing is spin-formed with a full-contour profiled constriction; the inner contour of the upper metal housing is buckled on the full-contour profiled constriction, and is laser welded with the lower metal housing to form a cavity for accommodating internal electronic components; the feedthrough assembly is laser continuously welded with the upper metal housing and the lower metal housing to form a closed cavity.

[0014] Furthermore, the feedthrough assembly is an oval-shaped feedthrough assembly; the oval-shaped feedthrough assembly includes an oval-shaped feedthrough flange, a feedthrough metal wire and an oval-shaped feedthrough ceramic; the oval-shaped feedthrough flange is arranged at one end of the oval-shaped feedthrough ceramic; the oval-shaped feedthrough flange is respectively welded to the outer wall of the upper metal shell and the outer wall of the lower metal shell through continuous laser welding to form a closed cavity; one end of the feedthrough metal wire passes through the oval-shaped feedthrough flange and is connected to the oval-shaped feedthrough ceramic; the feedthrough metal wire is used to interconnect the circuit in the metal sealed shell of the pacemaker with the circuit of the electrode connector in the polymer material top cover.

[0015] Furthermore, the feedthrough assembly is a circular feedthrough assembly; the circular feedthrough assembly includes a circular feedthrough flange, a feedthrough wire and a circular feedthrough ceramic; the circular feedthrough flange is arranged at one end of the circular feedthrough ceramic; the circular feedthrough flange is respectively welded to the outer wall of the upper metal shell and the outer wall of the lower metal shell by continuous laser welding to form a closed cavity; one end of the feedthrough wire passes through the circular feedthrough flange and is connected to the circular feedthrough ceramic; the feedthrough wire is used to interconnect the circuit in the metal sealed shell of the pacemaker with the circuit of the electrode connector in the polymer material top cover.

[0016] Furthermore, the shrinkage distances of the full-contour special-shaped shrinkages are equal.

[0017] Furthermore, the upper feed through slot and the lower feed through slot are both in a semi-circular shape.

[0018] Furthermore, the upper feed through slot and the lower feed through slot are both semicircular in shape.

[0019] Furthermore, the oval-shaped feedthrough ceramic and the circular feedthrough ceramic are both insulating filling materials; and the metal sealed housing assembly is made of pure titanium or titanium alloy material.

[0020] Furthermore, a molding process of a pacemaker housing structure comprises the following steps:

[0021] S1, a spinning wheel is used to press against the outer contour of the lower metal shell to apply rotational pressure, so that the opening structure of the lower metal shell shrinks inward; a supporting wheel is used to press against the inside of the lower metal shell and play a supporting role while rotating, so as to prevent the lower metal shell from deforming during the process of being pressed by the spinning wheel;

[0022] S2, the supporting wheel and the spinning wheel rotate simultaneously on the inner and outer sides of the same position of the lower metal shell; the movement tracks of the supporting wheel and the spinning wheel are the outer contour line of the lower metal shell;

[0023] S3, the relative distance between the supporting wheel and the spinning wheel is the wall thickness of the lower metal shell; through the interaction between the spinning wheel and the supporting wheel, a full-contour special-shaped shrinkage is formed on the opening edge of the lower metal shell.

[0024] Furthermore, in step S2, the support wheel and the lower metal shell rotate in the same direction, that is, counterclockwise; while the spinning wheel rotates in the opposite direction to the lower metal shell and the support wheel, that is, clockwise.

[0025] Furthermore, in the step S1, before the lower metal shell is spin-formed, the lower metal shell first goes through processes such as blanking, stamping, spinning, annealing, shaping, and punching, and then is cleaned and disinfected for use in the next process.

[0026] Beneficial effects of the present invention:

[0027] 1. The full-contour special-shaped shrinkage structure of the lower metal shell can replace the existing thermal insulation belt to play a role in heat insulation and isolation protection, effectively preventing the laser beam from directly penetrating the metal sheet and damaging the internal components.

[0028] 2. The inner contour surface of the full-contour special-shaped shrinking structure of the lower metal shell has the function of supporting and positioning the internal components; the outer contour surface of the full-contour special-shaped shrinking structure of the lower metal shell has the function of supporting and positioning the upper metal shell.

[0029] 3. By setting the full-contour special-shaped shrinkage, the poor welding situation that occurs when the insulation belt and the lower metal shell are welded in the prior art can be completely avoided.

[0030] 4. Compared with the prior art, the integrated full-contour special-shaped shrinkage structure has stronger structural strength and improves the reliability of the assembly of the upper metal shell and the lower metal shell.

[0031] 5. Compared with the existing technology, the integrated full-contour special-shaped shrinking structure has higher dimensional stability and dimensional accuracy than the assembly and welding of two parts.

[0032] 6. Compared with the existing technology, the integrated full-contour special-shaped shrinking structure reduces the number of parts, simplifies the assembly process, reduces the corresponding molds, fixtures, and processing equipment, reduces product costs, and improves the product's assemblability and finished product qualification rate. BRIEF DESCRIPTION OF THE DRAWINGS

[0033] Figure 1 It is a stereoscopic diagram of the 3D structure of the metal shell of a cardiac pacemaker in the prior art solution;

[0034] Figure 2 This is a welding assembly diagram of a metal shell and an insulating belt under the existing technical solution;

[0035] Figure 3 It is a schematic diagram of laser welding of a metal shell of a cardiac pacemaker according to the prior art solution;

[0036] Figure 4 It is a three-dimensional diagram of the 3D structure of the metal shell of the cardiac pacemaker of the present invention;

[0037] Figure 5 It is a schematic cross-sectional view of the laser welding structure of the metal shell of the cardiac pacemaker of the present invention;

[0038] Figure 6 is a schematic structural diagram of an assembled cardiac pacemaker pulse generator according to a first embodiment of the present invention;

[0039] Figure 7 is a feed-through assembly according to a first embodiment of the present invention;

[0040] Figure 8 is a schematic structural diagram of an assembled cardiac pacemaker pulse generator according to a second embodiment of the present invention;

[0041] Fig. 9 is a feed-through assembly according to a second embodiment of the present invention;

[0042] Fig.10 is a top view of the spin-formed lower metal shell of the present invention;

[0043] Fig.11 It is a side view of the spin forming of the lower metal shell of the present invention.

[0044] Explanation of the reference numerals: 1-the upper metal shell of the prior art; 101-the upper metal shell feed-through hole of the prior art; 2-the lower metal shell of the prior art; 201-the lower metal shell feed-through hole of the prior art; 3-the insulation belt of the prior art; 301-the insulation belt feed-through hole of the prior art; 4-the lower metal shell assembly of the prior art; 5-the upper metal shell of the present invention; 501-the upper feed-through slot of the present invention; 502-the inner contour of the upper metal shell of the present invention; 6-the lower metal shell of the present invention; 601-the lower feed-through slot of the present invention; 602-the full-profile special-shaped shrinking inner contour of the present invention; 603-the full-profile special-shaped shrinking outer contour of the present invention; 7-the feed-through assembly of the first embodiment; 701-the feed-through flange of the first embodiment; 702-the feed-through wire of the first embodiment; 703-the feed-through ceramic of the first embodiment; 8-the feed-through assembly of the second embodiment; 801-the feed-through flange of the second embodiment; 802-the feed-through wire of the second embodiment; 803-the feed-through ceramic of the second embodiment; 9-the support wheel; 10-the spinning wheel; 911-support wheel rotation direction; 111-spinning wheel rotation direction; 611-lower metal shell rotation direction. DETAILED DESCRIPTION

[0045] The present invention will be described in detail below with reference to the accompanying drawings and specific embodiments. The exemplary embodiments and descriptions of the present invention are used to explain the present invention, but are not intended to limit the present invention.

[0046] It should be noted that all directional indications in the embodiments of the present invention (such as up, down, left, right, front, back, upper end, lower end, top, bottom...) are only used to explain the relative position relationship, movement status, etc. between the components under a certain specific posture (as shown in the accompanying drawings). If the specific posture changes, the directional indication will also change accordingly.

[0047] In the present invention, unless otherwise clearly defined and limited, the term "connection" should be understood in a broad sense, for example, "connection" can be a fixed connection, a detachable connection, or an integral connection; it can be a mechanical connection or an electrical connection; it can be a direct connection or an indirect connection through an intermediate medium, it can be the internal connection of two elements or the interaction relationship between two elements, unless otherwise clearly defined. For ordinary technicians in this field, the specific meanings of the above terms in the present invention can be understood according to specific circumstances.

[0048] In addition, in the present invention, the descriptions of "first", "second", etc. are only used for descriptive purposes and cannot be understood as indicating or implying their relative importance or implicitly indicating the number of the indicated technical features. Therefore, the features defined as "first" and "second" may explicitly or implicitly include at least one of the features; in addition, the technical solutions between the various embodiments can be combined with each other, but they must be based on the ability of ordinary technicians in the field to implement them. When the combination of technical solutions is contradictory or cannot be implemented, it should be considered that such a combination of technical solutions does not exist and is not within the scope of protection required by the present invention.

[0049] like Figure 1 , Figure 3 and Figure 7 As shown, a specific implementation of the prior art includes an upper metal shell 1 of the prior art, a lower metal shell 2 of the prior art, an insulation belt 3 of the prior art, and an insulation belt feed-through assembly of the prior art.

[0050] like Figure 2 As shown, it is a specific implementation of the prior art, in which the insulating belt 3 is spot welded to the inner wall of the lower metal shell 2 according to the outer contour to form the lower metal shell assembly 4 of the prior art.

[0051] In a specific implementation of the prior art, the internal electronic components are sequentially assembled into the metal shell assembly 4 of the prior art, and then welded together with the metal shell 1 and the feedthrough assembly 7 to form a sealed whole. After leak detection by helium mass spectrometry, the next process is put into use.

[0052] The feedthrough form in the prior art may be the feedthrough component 7 of the first embodiment, may be the feedthrough component 8 of the second embodiment, or may be other forms of feedthrough components.

[0053] In a specific implementation of the prior art, since the insulation belt 3 is a narrow belt that is contoured, it requires precision die forming and shaping, and the development cost is relatively high. At the same time, the insulation belt 3 has the functions of heat insulation, positioning, and preventing laser penetration through the gap, so this process requires the use of a fixture for precise positioning. The process development is difficult. Since it is difficult to position the insulation belt and the metal shell during welding, it is easy to cause poor welding, resulting in an increase in the scrap rate.

[0054] like Figures 4 to 9As shown, a pacemaker housing structure comprises a metal sealed housing assembly, wherein: the metal sealed housing assembly comprises an upper metal housing 5, a lower metal housing 6 and a feedthrough assembly 7 or a feedthrough assembly 8; the upper ends of the side walls of the upper metal housing 5 and the lower metal housing 6 are respectively provided with an upper feedthrough groove 501 and a lower feedthrough groove 601 for placing the feedthrough assembly 7 or the feedthrough assembly 8; the opening edge of the lower metal housing 6 is spin-formed with a full-contour profiled constriction; the inner contour of the upper metal housing 5 is buckled on the full-contour profiled constriction, and is laser welded with the lower metal housing 6 to form a cavity for accommodating internal electronic components; the feedthrough assembly 7 or the feedthrough assembly 8 is respectively laser-welded with the upper metal housing 5 and the lower metal housing 6 to form a closed cavity;

[0055] The metal shell structure assembly provided by the present invention is composed of an upper metal shell 5, a lower metal shell 6 with a full-profile special-shaped shrinkage structure, and a feed-through assembly 7 or a feed-through assembly 8.

[0056] The necking structure of the lower metal shell 6 replaces the thermal insulation function of the prior art. The full-contour special-shaped necking outer contour 603 of the lower metal shell 6 has the functions of heat insulation and laser penetration prevention, and can perfectly cooperate with the inner contour 502 of the upper metal shell to achieve precise positioning and assembly of the upper metal shell 5 and the lower metal shell 6.

[0057] It should be noted that the full-contour special-shaped shrink inner contour 602 has the function of supporting and protecting internal components.

[0058] Specifically, in the present embodiment, the constriction of the lower metal shell 6 and the outer contour of the lower metal shell 6 are an integrated equidistant inward-constricted structure, which is formed by spinning, does not require additional shaping, and has precise positioning.

[0059] Embodiment 1, as Figure 7 As shown, the feedthrough component 7 of the first embodiment is oval in shape, and is composed of a feedthrough flange 701 of the first embodiment, a feedthrough metal wire 702 of the first embodiment, and a feedthrough ceramic 703 of the first embodiment.

[0060] Specifically, in this embodiment, the feed-through flange 701 of the first embodiment is made of metal, and is continuously laser welded with the upper metal shell 5 and the lower metal shell 6 to form a closed cavity.

[0061] Specifically, in the present embodiment, the feedthrough metal wire 702 of the first embodiment on the feedthrough assembly 7 of the first embodiment connects the circuit inside the metal sealed housing of the pacemaker with the circuit of the electrode connector inside the polymer material top cover, thereby forming a complete circuit connection part of the pacemaker pulse generator.

[0062] Specifically, in the solution of this embodiment, the feed-through ceramic 703 of the first embodiment in the feed-through assembly 7 of the first embodiment is an insulating filling material.

[0063] Embodiment 2, as Fig. 9 As shown, the feedthrough component 8 of the second embodiment is circular, and is composed of a feedthrough flange 801 of the second embodiment, a feedthrough metal wire 802 of the second embodiment, and a feedthrough ceramic 803 of the second embodiment.

[0064] Specifically, in this embodiment, the feed-through flange 801 of the second embodiment is made of metal, and is continuously laser welded with the upper metal shell 5 and the lower metal shell 6 to form a closed cavity.

[0065] Specifically, in the present embodiment, the feedthrough wire 802 of the second embodiment of the feedthrough assembly 8 of the second embodiment connects the circuit inside the metal sealed housing of the pacemaker with the circuit of the electrode connector inside the polymer material top cover, thereby forming a complete circuit connection part of the pacemaker pulse generator.

[0066] Specifically, in this embodiment, the feed-through ceramic 803 of the second embodiment of the feed-through assembly 8 of the second embodiment is an insulating filling material.

[0067] The shrinkage of the lower metal shell 6 is a full-contour special-shaped shrinkage configuration, and the shrinkage distance of the shrinkage is equal, which can fully support the contour and accurately position the upper metal shell 5 to prevent the two metal shells from being misaligned and causing poor welding.

[0068] In this embodiment, the process of making the metal sealed housing assembly is: assemble the internal electronic components into the lower metal housing 6 in sequence. Since the inner contour 602 of the retracted structure of the lower metal housing 6 matches the contour of the internal components, the electronic components inside the metal sealed housing assembly can be well positioned.

[0069] Specifically, in this embodiment, the upper metal shell inner contour 502 is buckled on the lower metal shell inner shrink structure outer contour 603. At this time, the full-profile special-shaped shrinking outer contour 603 of the lower metal shell 6 perfectly matches the upper metal shell inner contour 502, which can well fix the upper metal shell 5, ensure its position, prevent dislocation and height difference, and thus ensure the welding yield between the upper metal shell 5 and the lower metal shell 6.

[0070] Since the heat insulating belt 3 of the prior art and the lower metal shell 2 of the prior art are made into an integral structure in the form of a shrinkage, i.e., the lower metal shell 6 of the present invention, the positioning, assembly and welding processes of the heat insulating belt 3 of the prior art and the lower metal shell 2 of the prior art are reduced. Only a single positioning, assembly and welding of the upper metal shell 5 of the present invention and the lower metal shell 6 of the present invention is required, so that the purpose of first spot welding the heat insulating belt 3 of the prior art and the lower metal shell 2 of the prior art, and then positioning, assembling and welding the lower metal shell assembly 4 of the prior art with the metal shell 1 and the feed-through assembly 7 can be achieved.

[0071] The lower metal shell 6 is an improvement of the prior art, which combines the prior art insulation belt 3 and the prior art lower metal shell 2 into one part, thereby reducing the number of parts, saving the manufacturing mold of the insulation belt 3, reducing the number of welding times, reducing the tooling and fixtures used for welding, and completely avoiding the problem of poor welding between the prior art insulation belt 3 and the prior art lower metal shell 2.

[0072] like Figure 10 to Figure 11 As shown, the lower metal shell 6 realizes a full-contour shrinking structure of the lower metal shell 6 through a spinning process. It should be noted that the contour line of the full-contour shrinking structure is a non-rotating body special-shaped structure.

[0073] The movement trajectory of the lower metal shell 6 in the spinning process is the outer contour line of the lower metal shell 6 .

[0074] The spinning wheel 10 applies a rotational pressure to the outer contour line of the lower metal shell 6 to shrink the opening structure of the lower metal shell 6 .

[0075] During the spinning process, the support wheel 9 plays a supporting role while rotating inside the lower metal shell 6 , thereby preventing the lower metal shell 6 from deforming during the process of being pressed by the spinning wheel 10 .

[0076] The supporting wheel 9 and the spinning wheel 10 rotate simultaneously on the inner and outer sides of the same position of the lower metal shell 6 .

[0077] Specifically, in this embodiment, the relative distance between the supporting wheel 9 and the spinning wheel 10 is equal to the wall thickness of the lower metal shell 6 .

[0078] Specifically, in this embodiment, the support wheel 9 in the lower metal shell 6 rotates in the same direction as the lower metal shell 6, and the lower metal shell rotation direction 611 and the support wheel rotation direction 911 are both counterclockwise. The spinning wheel 10 outside the lower metal shell 6 rotates in the opposite direction to the lower metal shell 6 and the support wheel 9, and the spinning wheel rotation direction 111 is clockwise.

[0079] It should be noted that the rotation direction in this embodiment is only a preferred embodiment of the present invention, and this rotation direction is not necessarily the only direction in the actual spin forming process.

[0080] The manufacturing method of the lower metal shell 6 of the present invention adopts the processes of blanking, stamping, spinning, annealing, shaping, punching, etc., and then cleaning and disinfecting for use in the next process.

[0081] The invention has the advantages of simple structure and configuration, convenient processing, stable performance, complete functions and convenient operation.

[0082] It should be noted that, in this embodiment, the necking structure of the lower metal shell 6 may be formed by a spinning process or by other processes.

[0083] It should be noted that the metal shell material provided by the present invention can be pure titanium or titanium alloy.

[0084] The metal shell structure provided by the present invention is applicable to, but not limited to, implantable cardiac pacemakers, implantable cardioverter defibrillators (ICDs), cardiac resynchronization therapy defibrillators (CRT-Ds), cardiac resynchronization therapy pacemakers (CRT-Ps), implantable brain pacemakers, implantable neural stimulators, implantable spinal cord stimulators, implantable sacral neural stimulators, implantable vagus nerve stimulators, and the like.

[0085] The present invention designs a novel metal shell structure of a pacemaker with an integrated full-contour special-shaped shrinkage formed by spin forming and a process thereof, eliminates the insulation belt parts to reduce the assembly parts of the pacemaker pulse generator shell, simplifies the assembly process of the pacemaker, reduces the types of molds and tooling fixtures, improves the welding yield, and improves the reliability and safety of the product.

[0086] The technical solutions provided by the embodiments of the present invention are introduced in detail above. Specific examples are used herein to illustrate the principles and implementation methods of the embodiments of the present invention. The description of the above embodiments is only applicable to help understand the principles of the embodiments of the present invention. At the same time, for those skilled in the art, according to the embodiments of the present invention, there will be changes in the specific implementation methods and application scopes. In summary, the content of this specification should not be understood as limiting the present invention.

Claims

1. A cardiac pacemaker housing structure, comprising a metal sealed housing assembly, characterized in that: The metal sealed housing assembly comprises an upper metal housing, a lower metal housing and a feedthrough assembly; the upper ends of the side walls of the upper metal housing and the lower metal housing are respectively provided with an upper feedthrough groove and a lower feedthrough groove for placing the feedthrough assembly; the opening edge of the lower metal housing is spin-formed with a full-contour profiled constriction; the inner contour of the upper metal housing is buckled on the full-contour profiled constriction, and is laser welded with the lower metal housing to form a cavity for accommodating internal electronic components; the feedthrough assembly is laser continuously welded with the upper metal housing and the lower metal housing to form a closed cavity; The forming of the full-contour special-shaped necking comprises the following steps: S1, a spinning wheel is used to press against the outer contour of the lower metal shell to apply rotational pressure, so that the opening structure of the lower metal shell shrinks inward; a supporting wheel is used to press against the inside of the lower metal shell and play a supporting role while rotating, so as to prevent the lower metal shell from deforming during the process of being pressed by the spinning wheel; S2, the supporting wheel and the spinning wheel rotate simultaneously on the inner and outer sides of the same position of the lower metal shell; the movement tracks of the supporting wheel and the spinning wheel are the outer contour line 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; through the interaction between the spinning wheel and the supporting wheel, a full-contour special-shaped shrinkage is formed on the opening edge of the lower metal shell.

2. A cardiac pacemaker housing structure according to claim 1, characterized in that: The feedthrough assembly is an oval-shaped feedthrough assembly; the oval-shaped feedthrough assembly includes an oval-shaped feedthrough flange, a feedthrough metal wire and an oval-shaped feedthrough ceramic; the oval-shaped feedthrough flange is arranged at one end of the oval-shaped feedthrough ceramic; the oval-shaped feedthrough flange is respectively welded to the outer wall of the upper metal shell and the outer wall of the lower metal shell through continuous laser welding to form a closed cavity; one end of the feedthrough metal wire passes through the oval-shaped feedthrough flange and is connected to the oval-shaped feedthrough ceramic; the feedthrough metal wire is used to interconnect the circuit in the metal sealed shell of the pacemaker with the circuit of the electrode connector in the polymer material top cover.

3. A cardiac pacemaker housing structure according to claim 2, characterized in that: The feedthrough assembly is a circular feedthrough assembly; the circular feedthrough assembly comprises a circular feedthrough flange, a feedthrough wire and a circular feedthrough ceramic; the circular feedthrough flange is arranged at one end of the circular feedthrough ceramic; the circular feedthrough flange is respectively welded to the outer wall of the upper metal shell and the outer wall of the lower metal shell by continuous laser welding to form a closed cavity; one end of the feedthrough wire passes through the circular feedthrough flange and is connected to the circular feedthrough ceramic; the feedthrough wire is used to interconnect the circuit in the metal sealed shell of the pacemaker with the circuit of the electrode connector in the polymer material top cover.

4. A cardiac pacemaker housing structure according to claim 1, characterized in that: The inward shrinkage distances of the full-contour special-shaped shrinkages are equal.

5. A cardiac pacemaker housing structure according to claim 2, characterized in that: The upper feed-through slot and the lower feed-through slot are both in a semi-circular shape.

6. A cardiac pacemaker housing structure according to claim 3, characterized in that: The upper feed through slot and the lower feed through slot are both semicircular in shape.

7. A cardiac pacemaker housing structure according to claim 3, characterized in that: The oblong-shaped feedthrough ceramic and the circular feedthrough ceramic are both insulating filling materials; the metal sealed housing component is made of pure titanium or titanium alloy material.

8. A cardiac pacemaker housing structure according to claim 1, characterized in that: In step S2, the support wheel and the lower metal shell rotate in the same direction, that is, counterclockwise; the spinning wheel rotates in the opposite direction to the lower metal shell and the support wheel, that is, clockwise.

9. A cardiac pacemaker housing structure according to claim 1, characterized in that: In the step S1, before the lower metal shell is spin-formed, the lower metal shell first goes through processes such as blanking, stamping, spinning, annealing, shaping, and punching, and then is cleaned and disinfected for use in the next process.

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