Manufacturing method for implantable intracardiac devices and each header assembly

Abstract

The present invention relates to a method for manufacturing a header assembly for an implantable intracardiac device and a method for manufacturing an intracardiac device, the header assembly comprising at least one tine 3,103 extending from a base ring 33,133, the base ring 33,133 being formed in a conical shape, the header assembly comprising a header cap 2,102 and a header base 1,101, the header cap 2,102 and the header base 1,101 comprising supporting sides 43,53,143,153 respectively corresponding to the conical shape of the base ring 33,133, the manufacturing method comprising an assembly step, in which the base ring 33,133 is placed between the header base 1,101 and the header cap 2,102, and a subsequent fastening step, in which the header cap 2,102 is permanently fastened to the header base 1,101 such that the base ring 33,133 is located in the base ring groove.

Description

Technical Field

[0001] The present invention relates to an implantable intracardiac device such as an implantable cardiac pacemaker and a header assembly therefor.

Background Art

[0002] Active or passive intracardiac medical devices (IMDs), such as implantable cardiac pacemakers (also known as leadless pacemakers), are well-known small medical devices that are fully implanted within the ventricles or atria. Intracardiac pacemakers are used for patients suffering from bradycardia, i.e., when the heartbeat of the heart is too slow to meet the patient's physiological needs. The intracardiac pacemaker applies electrical stimulation in the form of pulses to the heart to generate a physiologically appropriate heart rate and / or in the form of shocks for cardioversion or defibrillation to restore a more normal heart rhythm. Alternative or additional functions of the intracardiac device include providing other electrical or electromagnetic signals to the heart or its surrounding tissue and sensing electrical or electromagnetic signals or other physiological parameters of the heart and / or its surrounding tissue.

[0003] U.S. Patent Application Publication 2012 / 0172690(A1) discloses a leadless pacemaker device comprising a multi-piece tine fixation subassembly with a set of four remotely deployable active fixation tines at the distal end. The document further describes fixing the pacemaker to patient tissue using four circularly arranged tines during minimally invasive surgery. The tines are configured to enter and exit the patient's cardiac tissue when deployed and positioned adjacent to the tissue to securely fix the device and provide mechanical contact of the electrodes to the patient's tissue within the center of the circular arrangement of active fixation tines. This known document further discloses a complex manufacturing method including several steps for mounting a header assembly, and seven components that need to be mounted together to form the header assembly. U.S. Patent No. 10,179,236(B2) provides another example of a leadless pacemaker with a header.

[0004] In known header solutions integrated into devices with market-standard device sizes, the header design can take up space from other critical components, such as batteries or electronic modules, impacting device lifespan or more critical device functions, such as therapeutic functions that could have been incorporated into larger electronic modules.

[0005] Another issue is that known solutions for implantable intracardiac devices either include a fixed mounting mechanism that is axially adjustable for deployment or an anti-rotation mechanism. The drawback of these existing solutions is that rotation of the device relative to the fixing mechanism is prohibited during emergency or prolonged device removal, thereby adding procedural challenges during device removal depending on the varying degree of tissue encapsulation.

[0006] During manufacturing, known solutions involve using sophisticated alignment methods to secure the tine array to the medical implant housing. For example, precisely aligning small components to each other is required before assembly, and highly distributing adhesive in microgram amounts or aligning bayonet functions is necessary to combine the header assembly with the device housing or to combine the header assembly components. Furthermore, securing the tines requires complex injection-molded parts with notches to receive the tines. Therefore, automation is difficult with conventional manufacturing methods. In addition, the use of silicone adhesives may necessitate manual cleaning after manufacturing. [Prior art documents] [Patent Documents]

[0007] [Patent Document 1] U.S. Patent Application Publication No. 2012 / 0172690(A1) [Patent Document 2] U.S. Patent No. 10,179,236 (B2) [Overview of the Initiative] [Problems that the invention aims to solve]

[0008] Therefore, there is a need for implantable intracardiac devices that have smaller dimensions, robust mounting mechanisms, lower manufacturing effort and cost, and the potential for automation. [Means for solving the problem]

[0009] The above problems are solved by the method for manufacturing a header assembly as defined in claim 1, the method for manufacturing an implantable intracardiac device as defined in claim 6, the respective header assemblies as defined in claim 9, and the respective implantable intracardiac devices as defined in claim 10.

[0010] In particular, a method for manufacturing a header assembly for an implantable intracardiac device, wherein the header assembly comprises at least one tine extending from a base ring, the base ring being formed in a conical shape, the header assembly further comprises a header cap and a header base, the header cap and the header base each comprising support sides corresponding to the conical shape of the base ring, and the manufacturing method comprises the following steps, namely: - An assembly step in which the base ring is positioned between the header base and the header cap such that the base ring is adjacent to the side of the support header base of the header base and the side of the support header cap of the header cap, - The next fixing step involves permanently securing the header cap to the header base such that, during assembly, the base ring is positioned within the base ring groove formed by the side of the support header cap and the side of the support header base. Includes.

[0011] The header assembly may further comprise a washer-like spacer that can form or contain a drug depot, for example, a steroid depot containing a DXA steroid in particular.

[0012] An implantable intracardiac device of the present invention, such as a leadless pacemaker, comprises a cylindrical housing and a header assembly manufactured by the manufacturing method described above and in the following further embodiments. The cylindrical housing, header assembly, and pin electrodes of the intracardiac device have a longitudinal axis that forms a longitudinal direction extending from the proximal end to the distal end when assembled. Furthermore, the pin electrodes protrude from the distal end of the housing, and the header assembly is positioned and mounted at the distal end of the housing of the intracardiac device such that the electrodes protrude from the header assembly, i.e., from each through or full opening of the header assembly. The opening may be a central opening. In one embodiment, a feedthrough may be positioned around and at the proximal end of the pin electrodes and may protrude at least partially through the opening of the header assembly.

[0013] The base ring, header cap, and header base, and, where applicable, the washer-shaped spacer, may have the openings described above, and the size of the openings in the spacer may be such that a pin-shaped electrode, or an electrode feedthrough located at the proximal end of the electrode, can be positioned within the openings.

[0014] The header assembly, as described in more detail above and below, is housed at the distal end of the intracardiac device and provides a fixed portion of a tine base consisting of at least one tine. The proximal end of the header assembly is formed by the header base after the header assembly has been fixed to the intracardiac device. The header cap and washer-like spacer may be formed separately or integrally.

[0015] In one embodiment, the header assembly comprises a plurality of tines, particularly two, three, four, five, or six, extending from the distal end of the base ring, the tines being evenly distributed along the entire circumference of the base ring. The base ring is formed conically such that its distal end has a larger inner and outer diameter than its proximal end. The axis of the base ring extends parallel to the axis of the housing of the intracardiac device, in other words, from the proximal to the distal direction. At least one tine can secure the device in cardiac tissue after deployment.

[0016] The cylindrical housing of the intracardiac device comprises an electronic module having a processor, an energy source (e.g., a battery or coil (for wireless charging)), and, where applicable, communication components such as an antenna. The processor may be adapted to process signals determined from the patient's body or received from the surrounding environment, and / or to generate signals for the treatment of the patient's heart. Such signals may include electrical stimulation in the form of pulses to generate a physiologically appropriate heart rate, shocks for cardioversion or diffiblation to restore a more normal heart rhythm, and / or other electrical or electromagnetic signals to the heart or its surrounding tissues. Such signals may be converted and transmitted by the electronic module and applied to the heart or its surrounding tissues by pin electrodes. The pin electrodes are electrically connected to the electronic module and the energy source. The sealed housing may contain a conductive material, such as titanium, and can function as another electrode using a regional coating, such as fractal iridium, to increase the effective electrically active surface area.

[0017] The manufacturing method of the present invention for header assemblies advantageously allows for the automation of assembly. Furthermore, the manufacturing method of the present invention is very simple and therefore cost-effective, as no bonding process or rotational fixing method is required in the proposed manufacturing steps. The manufacturing method of the present invention involves only single-axis assemblies, even small parts, which are ready for automation.

[0018] Furthermore, the aforementioned header assembly optimizes space with a conical base ring and has fewer header components, resulting in fewer processing and assembly steps during the manufacturing of implantable intracardiac devices and lower costs. The base ring is conical in shape so that the axial height can be reduced while maintaining the height of the band. The axial length and volume of the header are minimized. When implemented in a leadless pacemaker, this improvement allows for more space for other more critical functions of the device, such as the battery, and can extend the device's lifespan. In other words, that space can be allocated to electronic modules to incorporate more therapeutic functions. Conversely, for the same size battery and electronic modules, shortening the header length allows for a shorter overall device length. This enables application to smaller patients or alternative placement within the heart, such as in the right atrium.

[0019] In one embodiment, the base ring has multiple notches (i.e., cutouts, slots, or other shapes in the material), for example, at least two groups of two notches arranged adjacently in the circumferential direction within the distal end face of the base ring and extending from the distal end into the body of the base ring. The length of one notch may be at least 1 / 4 of the length of the base ring (i.e., the axial dimension) and up to 2 / 3 of the length of the base ring. In another embodiment, the length of the notches may be at least 1 / 2 of the length of the base ring. Multiple notches make it possible to reduce distortion during the shaping process.

[0020] In one embodiment, each of at least one tine has a contact portion that extends directly from the base ring and forms a connection with the base ring and flex zone, the contact portion of the tine continuing the conical shape of the base ring. Each of the plurality of tines terminates with a base ring tangent to the arc of the tine just below the surface of the header cap, the base ring being fully accommodated by the header cap at its distal end and by a spacer at its proximal end. The middle portion of each of the plurality of tines has a curved shape (e.g., a circular curve), and the end furthest from the base ring includes an outwardly twisted straight portion. Other shapes of each tine are similarly possible. In one embodiment, the base ring and at least one tine are integrally formed. The base ring and / or at least one tine may be made of a partially or fully biocompatible material, such as a superelastic material, such as nitinol.

[0021] The header cap can form a secure connection of at least one tine to the housing of the intracardiac device, allowing for rotational degrees of freedom of the tine array (see below). Furthermore, the header cap can electrically isolate the tine from the device housing and can enable staking methods for uniaxial assemblies, such as ultrasonic staking. The header cap has a rotationally symmetric design, for example, a substantially hollow cylindrical shape with supporting sides (supporting header cap sides) corresponding to the conical shape of the base ring. This means that the size and inclination of the supporting sides correspond to the size and taper of the base ring. The header cap can provide a flange projecting inward from its inner surface, where applicable, forming a seat for a washer-like spacer. This allows the header cap to permanently secure a steroid depot to the device. Furthermore, the distal end of the header cap can be sized and shaped to be suitable for the application of a welded horn, i.e., the application of a relatively smooth and flat surface to enable a welded horn tooling interface.

[0022] A base ring having at least one tine is clamped and fixed against longitudinal movement between the (proximal) header base and the (distal) header cap of the header assembly, more precisely between the support header base side face and the support header cap side face. The header base prevents the base ring from contacting the device housing and from damaging any coating material (e.g., parylene) on the device housing.

[0023] The header base is radially symmetric and further has a ring structure. One of the inner surfaces is formed as a support side face (support header base side face) corresponding to the conical shape of the base ring, which means that the size and inclination of the support side face correspond to the size and conicity (taper) of the base ring.

[0024] The header base and the header cap may include an electrically insulating and thermoplastic material, such as PEEK. PEEK is ideal due to its mechanical strength, biocompatibility, and insulation properties.

[0025] According to the present invention, in the assembly step, the components of the header assembly are arranged adjacent to each other. That is, the base ring is arranged between the header base and the header cap such that the base ring is adjacent to the support header base side surface of the header base and adjacent to the support header cap side surface of the header cap. In the next fixing step, the header cap is permanently fixed to the header base such that the base ring is located within the base ring groove formed by the support header cap side surface and the support header base side surface and is completely accommodated. Due to the conicity of the base ring and the side surfaces of the header cap and the header base, the base ring having tines cannot be pulled out of or otherwise removed from the header assembly and is permanently fixed to the header assembly. Since the base ring has a conical shape, it cannot be removed from the conical pocket formed by the support header cap side surface and the support header base side surface and is firmly attached to the intracardiac device.

[0026] In one embodiment, the header cap and the header base are fixed by heat staking or ultrasonic staking, or by mechanical welding, such as spin welding, friction stir welding, vibration welding, and / or ultrasonic welding. This is achieved, for example, when the header base and the header cap comprise or consist of materials suitable for welding and / or staking. In order to apply a welding horn during the fixing step, the header cap has respective lateral sides at its most distal end that form an end face of appropriate size. The welding horn can provide a longitudinal pressing force and / or vibrations in the ultrasonic range, for example, a frequency in the range of 20 kHz to 70 kHz, an amplitude of 30 mm to 50 mm, a staking force of 60 N to 100 N, and a staking time of up to 2 seconds, particularly up to 1.5 seconds.

[0027] In one embodiment, each of the header base and header cap has lateral surfaces next to each of its supporting surfaces that are at least partially adjacent to each other after the assembly step, and permanent fastening of the header cap and header base is at least partially provided at each of the lateral surfaces. The lateral surfaces of the header base and header cap may extend at least partially parallel after the assembly step. Each lateral surface may extend perpendicular, parallel, or inclined with respect to the longitudinal axis of the header assembly or the housing of the intracardiac device. These surfaces form staking or welding areas that provide material-to-material connection after the fastening step.

[0028] In one embodiment, the header cap and / or header base are provided with projections on each of their lateral sides, and at least a portion of the material forming the projection is used for fixing the header cap to the header base. Thus, particularly during welding, the material of the projection melts to provide material for permanent connection with the other respective components, thereby forming a connection (join) between the materials. In one embodiment, the other respective components may have recesses on the opposite side of the respective projection to form an additional interlocking connection during the fixing step. The projections can be formed, for example, by a single cone or ridge of another form located on the surface of each lateral side of the header cap and / or header base, with at least two or more cones distributed along the entire circumference of each lateral side. Alternatively, the projections can be formed as a raised ring having, for example, a triangular cross-section, located on each lateral side. In one embodiment, the ring, cone, or ridge forms a very sharp ridge at its apex.

[0029] In one embodiment, the base ring groove is sized such that a conical base ring can rotate within the base ring groove relative to the housing of the intracardiac device after the fixation step. In one embodiment, the base ring groove is closed at its proximal end by the lateral sides of a header base and header cap fixed to each other, such that an inclined slot or pocket for the base ring is closed, as a result the base ring is fixed rotatably. This provides rotational freedom of the device relative to the fixation mechanism, allowing release from sealed tissue without compromising the stability of the fixation mechanism, i.e., at least one tine.

[0030] The manufacturing method of the present invention for an implantable intracardiac device includes, in particular, the step of permanently attaching the header assembly manufactured by the manufacturing method described above to the intracardiac device, for example, to the distal end of the housing and / or to a pin-shaped electrode or feedthrough that both protrudes from the distal end of the housing. The completed intracardiac device has the advantages described above with respect to the header assembly.

[0031] In one embodiment, one of the pin electrodes or feedthroughs of the intracardiac device is provided with, for example, at least one receptive notch that forms a recess or undercut on its shell surface or side surface, so that the molten portion of the header cap or header base flows into the receptive notch during the header assembly fixing step. The receptive notch may be formed as a ring notch or a plurality of single notches distributed regularly or irregularly along the periphery of the respective shell surface or side surface. This simultaneously fixes the header assembly to the intracardiac device during the header assembly fixing step. At least one receptive notch allows for localized material flow, enabling the header base of the header assembly to be fixed to the intracardiac device housing. The molten material of the molten portion enables interlocking connection with the pin electrodes or feedthrough. To this end, the header assembly needs to be positioned at the distal end of the intracardiac device housing, after or during the assembly step, so that the pin electrodes and / or feedthrough are located within the aforementioned openings of the header assembly. In one embodiment, the molten portion is provided by projections formed on the respective lateral surfaces of the header cap and / or header base.

[0032] The above problems are solved by a header assembly manufactured using the above manufacturing method, or by an implantable intracardiac device manufactured using the above manufacturing method.

[0033] In one embodiment, the distal end of the housing of the intracardiac device is provided with a recess having an annular projection on its outer circumference that protrudes distally. The header base is suitable for being fixed into this recess, and the annular projection forms an outer rim for the header base, thereby protecting the header base after the header assembly has been fixed in the housing.

[0034] Further additional functionality may be provided by the header assembly or intracardiac device. That is, - The header base is used to house the tine array while ensuring electrical isolation from the housing. - The header cap provides an internal diameter that functions to interact with a portion of the housing implant or feedthrough flange.

[0035] The present invention is described further hereby with reference to the attached schematic diagrams. [Brief explanation of the drawing]

[0036] [Figure 1] A side view shows a first embodiment of the intracardiac device of the present invention, which includes a header assembly. [Figure 2] A side view of the embodiment shown in Figure 1 during assembly is provided. [Figure 3] A cross-sectional view of the header cap of the embodiment shown in Figure 1 is provided. [Figure 4] The header base of the embodiment shown in Figure 1 is shown in a cross-sectional view. [Figure 5] A cross-sectional view of the embodiment shown in Figure 1 during manufacturing is provided. [Figure 6] The distal end of the housing of an intracardiac device equipped with pin-shaped electrodes is shown in a side view. [Figure 7] A cross-sectional view of the embodiment shown in Figure 1 after the completion of the fixing step is provided. [Figure 8] A second embodiment of the intracardiac device of the present invention, equipped with a header assembly, is shown in exploded perspective and cross-sectional views. [Figure 9] A cross-sectional view of the embodiment shown in Figure 8 after the completion of the fixing step is provided. [Figure 10] Figure 8 shows a cross-sectional view of an example of the fixing step in the manufacturing method. [Figure 11] A third embodiment of the intracardiac device of the present invention, with a header assembly after the completion of the fixing step, is shown in a cross-sectional view. [Modes for carrying out the invention]

[0037] Figure 2 shows an exploded view of a first embodiment of an implantable intracardiac device with a header assembly, such as a leadless pacemaker, while Figure 1 shows the distal end of the device after the fixing step of the manufacturing method is completed. The components are an annular header base 1, a basically cylindrical header cap 2, four tines integrally formed with the base ring 33, a cylindrical device housing 5, and pin-shaped electrodes 7 extending distally therefrom. A common longitudinal axis 10 is also shown in Figures 1 and 2.

[0038] The base ring 33 is formed in a conical shape such that its distal end 33a has a larger diameter than its proximal end 33b.

[0039] Tine 3 extends from a conical base ring 33. The base ring 33 may have four groups of three material relief notches (slots) 31 (only one group and parts of the other two groups are shown), each extending distally into the body of the base ring 33 to allow for shaping of the conical base ring 33. The notches 31 are located on the circumference of the base ring 33, with one of the notches 31 positioned adjacent to another. Each tine has a contact portion (flex zone) 3a, a curved middle portion, and an outwardly twisted straight end (farthest from the base ring 33). Tine 3 mechanically secures the intracardiac device within the patient's heart after exposure and penetration of cardiac tissue, so that the central electrode 7 makes mechanical and electrical contact with the internal tissue of the patient's heart in one ventricle or atrium.

[0040] Each component, such as the header base 1, header cap 2, and base ring 33, is provided with a central through-opening (opening 41 in the header cap 2 and opening 51 in the header base 1, see Figure 1) for housing the electrode 7. The diameter of the central opening is such that the electrode 7 is located within the opening when the manufacturing process is completed.

[0041] The intracardiac device housing 5 includes a battery and an electronic module comprising a processor, ensuring the sealing of these components. These components are electrically connected to the electrodes 7 and provide electrical stimulation of the heart or processing of electrical signals determined from the heart. Furthermore, the housing may include communication components such as an antenna. The device housing 5 of the intracardiac device may be coated with parylene provided by a vapor deposition process to insulate the body of the housing 5 from the electrodes 7.

[0042] The basically cylindrical, rotationally symmetric header cap 2 shown in Figure 3 comprises the aforementioned central opening 41 for the electrode 7, an inclined side surface 43 formed on the outer surface of the header cap 2, a lateral side surface 45 extending perpendicular to the longitudinal axis 10, and an annular projection 46 located on the lateral side surface 45, which forms a ridge at its top. The annular projection 46 is further located adjacent to the central opening 41.

[0043] Figure 4 shows an annular, radially symmetrical header base 1, which has a central opening 51, a lateral side surface 55, and an inclined side surface 53 formed on the inner surface of the header base 1.

[0044] Figure 6 can be deduced that the pin-shaped electrode 7 has a receptive notch (annular recess) 7a at its proximal end.

[0045] During the first step of the manufacturing method of the present invention for a header assembly and intracardiac device, the header cap 2, the base ring 33 having tines 3, and the header base 2 are positioned in this order such that the support sides 43 of the header cap 2 and the support sides 53 of the header base 1 are adjacent to the conical base ring 33 (see Figure 5). As shown in Figure 2 (see arrow 39), the above components are moved in the illustrated order toward the distal end of the housing 5 of the intracardiac device in order to fix the header assembly to the housing 5 and the pin electrodes 7, simultaneously with fixing the components of the header assembly. Furthermore, the electrodes are positioned inside the opening 41 of the header cap 2 and the opening 51 of the header base 1. Alternatively, the components of the header assembly may be fixed first (by fixing the header cap 2 to the header base 1, as shown below) and then fixed to the housing 5 and the pin electrodes 7. Furthermore, at the end of the assembly step, the lateral side 45 of the header cap 2 is positioned adjacent to the lateral side 55 of the header base 1. The projection 46 of the header cap 2 contacts the opposing lateral surface 55 of the header base 1 (see Figure 5). Furthermore, the projection 46 is located near the receiving notch 7a of the pin-shaped electrode 7 shown in Figure 6.

[0046] During the next fixing step, the components of the header assembly are permanently fixed to the housing 5 having the pin-shaped electrodes 7 of the intracardiac device. The resulting configuration is shown in Figure 7. For ultrasonic welding, the sonotrode 200 may be placed in the header cap 2, as shown in Figure 10 for a second embodiment.

[0047] Ultrasonic welding is performed by pressing onto the header cap 2, which contains thermoplastic material, and by vibration within the ultrasonic range (typical frequencies of 20 kHz to 70 kHz). This high-frequency excitation heats the thermoplastic material of the header cap 2 at the interface with the header base 1 (i.e., the lateral sides 45, 55 and projection 46), causing the thermoplastic material to begin melting. The molten plastic material begins to flow and engages with the receiving notch 7a provided on the pin electrode 7. After welding, the plastic material of the header cap 2 and / or the header base 1 cool and solidify at the interface between the header cap 2 and the header base 1, i.e., at the lateral sides 45, 55 and within the receiving notch 7a (see reference no. 57 in Figure 7). As a result, a material-to-material and interlocking permanent connection is achieved between the components of the header assembly and the intracardiac device housing 5 with the pin electrode 7 (see Figure 7).

[0048] Furthermore, the connection of the materials of the header cap 2 and the header base 1 forms an interface between the lateral surfaces 45 and 55 of these components, thereby closing the proximal end of the inclined pocket formed by the support surface 43 of the header cap 2 and the support surface 53 of the header base 1, and the pocket fully accommodates the base ring 33. This inclined arrangement of the pocket prevents the base ring 33 from disengaging, allowing the base ring 33 and, consequently, the tine 3, to rotate within the pocket relative to the intracardiac device housing 5.

[0049] Ultrasonic staking of the upper cap against the lower cap is typically performed at frequencies of 20 kHz to 70 kHz. The sonotrode 200 transmits ultrasonic vibration energy into the header cap 2 (see also Figure 10).

[0050] A second embodiment of the intracardiac device and header assembly is shown in Figures 8 to 10. Most of the components of the intracardiac device are shown in Figures 1 to 7 and will not be described in detail again. The reference number of one component or function in the second embodiment is exactly 100 greater than the corresponding component or function in the first embodiment.

[0051] However, there are some differences compared to the first embodiment. Specifically, the intracardiac device of the second embodiment further includes a feedthrough 106. Formed basically as a hollow cylinder, the feedthrough 106 is located at the distal end of the housing 105 of the intracardiac device and surrounds the pin-shaped electrode 107 at its proximal end. Thus, during welding, a receiving notch 106a for the molten material is provided on the shell surface of the feedthrough 106. Furthermore, the header assembly includes a washer-shaped spacer 104 that can form or accommodate a drug depot, such as a steroid depot. To secure the washer-shaped steroid 104, the header cap 102 includes a flange-shaped projection 148 formed on the inner surface of the opening 141. The diameter of the electrode feedthrough 106 is larger than the diameter of the electrode 7.

[0052] The lateral surface 155 of the header base 101 extends partially parallel to the longitudinal axis 110 and partially perpendicular to this axis, and is formed by an inner surface. The lateral surface 145 of the header cap 102 extends partially parallel to the longitudinal axis and is formed by an outer surface that is partially inclined with respect to this axis. An annular projection 146 is formed at the nearest end of the header cap 102, having a ridge at its proximal apex.

[0053] During the assembly step, the components of the header cap and intracardiac device are positioned close to each other in a predetermined order, as indicated by the arrow 139 extending parallel to the longitudinal axis 110 in Figure 9. A washer-like spacer 104 is positioned between the flange-like projection 148 of the header cap 102 and the distal end face of the feedthrough 106. Next, the following fixing step is performed, as described in relation to the first embodiment above. The application of the sonotrode 200 on the end face of the header cap 102 is shown in Figure 10. By ultrasonic excitation, the material of the annular projection 146 is melted and flows into the receiving notch 106a of the feedthrough 106, thereby permanently engaging the header assembly with the intracardiac device and its housing 105. Furthermore, by forming material-to-material connections at the interfaces of the lateral sides 145 and 155, the inclined pocket is formed by the support surfaces 143 and 153 of the header cap 102 and header base 101, respectively, for housing the base ring 133. The washer-shaped spacer 104 is clamped by the flange-shaped projection 148 and fixed to the intracardiac device.

[0054] A third embodiment of an intracardiac device manufactured by the manufacturing method of the present invention described above is shown in Figure 11. This device is similar to the second embodiment, except for two circular grooves (instead of one) in the feedthrough shell surface that form two receptive notches 106b. Each receptive notch 106b is shallower than a single receptive notch 106a. During the fixation step, these notches 106b receive the molten material to be subsequently solidified and provide interlocking connections for the header assembly and the intracardiac device.

[0055] Header caps 2, 102 and header bases 1, 101 contain PEEK or are made of PEEK or other thermoplastic material.

[0056] The intracardiac device equipped with the header assembly of the present invention has its axial length shortened by the conical base rings 33, 133. Therefore, it does not interfere as much with the mechanism of the cardiac cycle and is more suitable for difficult situations relating to smaller patients and hearts (e.g., intraatrial regulation of the heart).

[0057] The header assembly geometry described above enables a simplified and automated single-axis assembly. Furthermore, the header assembly geometry allows for rotational movement of the base rings 33, 133 relative to the intracardiac device housing. This is advantageous for emergency or prolonged device removal when varying degrees of encapsulation are present, as it allows the intracardiac device housing to be rotated relative to the base rings 33, 133 using at least one tine 3, 103 to release the device from encapsulation without tearing the tissue engaged with at least one tine 3, 103.

Claims

1. A method for manufacturing a header assembly for an implantable intracardiac device, wherein the header assembly comprises at least one tine (3, 103) extending from a base ring (33, 133), the base ring (33, 133) being formed in a conical shape with increasing diameter distally, the header assembly further comprises a header cap (2, 102) and a header base (1, 101), the header cap (2, 102) and the header base (1, 101) each comprising support sides (43, 53, 143, 153) corresponding to the conical shape of the base ring (33, 133), and the manufacturing method comprises the following steps, i.e., The assembly step involves positioning the base ring (33, 133) between the header base (1, 101) and the header cap (2, 102) such that the base ring (33, 133) is positioned adjacent to the support header base side surface (53, 153) of the header base (1, 101) and the support header cap side surface (43, 143) of the header cap (2, 102), The next fixing step is to permanently fix the header cap (2, 102) to the header base (1, 101) such that the base ring (33, 133) is positioned within the base ring groove formed by the support header cap side surfaces (43, 143) and the support header base side surfaces (53, 153). Includes, A manufacturing method wherein the base ring groove is sized such that the conical base ring (33, 133) can rotate within the base ring groove after the fixing step.

2. The manufacturing method according to claim 1, wherein each of the header base (1, 101) and the header cap (2, 102) has lateral sides (45, 55, 145, 155) extending perpendicular to the longitudinal axis of the header assembly, next to each of its support sides (43, 53, 143, 153) which are at least partially adjacent to each other after the assembly step, and the permanent fastening of the header cap (2, 102) to the header base (1, 101) is at least partially provided at each of its lateral sides (45, 55, 145, 155).

3. The manufacturing method according to claim 2, wherein the header cap (2, 102) and / or the header base (1, 101) are provided with projections (46, 146) on each of their lateral sides (45, 55, 145, 155), and at least a portion of the material forming the projections (46, 146) is used for fixing the header cap (2, 102) to the header base (1, 101).

4. The manufacturing method according to any one of claims 1 to 3, wherein the header cap (2, 102) and the header base (1, 101) are fixed by heat staking, ultrasonic staking, or mechanical welding.

5. A step of manufacturing the header assembly by the manufacturing method described in any one of claims 1 to 4, During the fixing step, there is a step of permanently attaching the header assembly to the intracardiac device. A method for manufacturing an implantable intracardiac device, including the invention.

6. The manufacturing method according to claim 5, wherein the pin-shaped electrode (7) of the intracardiac device is provided with at least one receptive notch (7a) on the side surface of the pin-shaped electrode (7), and as a result, the material of the projection (46) formed on the lateral side surface of at least one of the header cap (2) and the header base (1) that extends perpendicular to the longitudinal axis of the header assembly melts during the fixing step of the header assembly and flows into the receptive notch (7a).

7. The manufacturing method according to claim 5, wherein the feedthrough (106) of the intracardiac device is located at the distal end of the housing (105) of the intracardiac device and surrounds the pin electrode (107) of the intracardiac device at the proximal end of the feedthrough (106) comprises at least one receptive notch (106a, 106b) on the side surface of the feedthrough (106), and as a result, the material of the projection (146) formed on the lateral side surface of at least one of the header cap (102) and the header base (101) that extends perpendicular to the longitudinal axis of the header assembly melts during the fixing step of the header assembly and flows into the receptive notch (106a, 106b).

8. The manufacturing method according to claim 7, wherein the header cap (2, 102) is permanently fixed to the feedthrough (106) either directly or via the header base (1, 101).

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