IMPLANTABLE MEDICAL DEVICE WITH MODULAR INJECTION MOLDED HEADER ASSEMBLY AND RELATED METHODS OF MANUFACTURE
Disclosed herein is an implantable electronic device. In one embodiment, the device has a modular header-feedthru assembly and a housing. The modular header-feedthru assembly has a conductor assembly, a feedthru coupled to the conductor assembly, and a polymer header that is injected molded about the conductor assembly and at least a portion of the feedthru. The housing is welded to the feedthru.
This present application is a continuation of, and claims priority to, U.S. application Ser. No. 15/073,294, which was filed on 17 Mar. 2016, the complete subject matter of which is expressly incorporated herein by reference in its entirety.
BACKGROUNDEmbodiments of the present invention relate to medical apparatus and methods. More specifically, the present invention relates to systems and methods for manufacturing a header assembly of an implantable electronic device such as an implantable pulse generator or implantable cardiac monitor.
Implantable electronic devices (IEDs) include pulse generators (IPGs) such as pacemakers and implantable cardioverter defibrillators (ICDs), which are used in the treatment of cardiac conditions, and neuromodulators or neurostimulators, which are used in chronic pain management or the actuation and control of other body systems. These IPGs commonly include a housing, feedthrus, and a connector assembly that is enclosed in a header and includes many internal electrically conductive components such as, for example, wires, ribbon, antennas, blocks, rings, etc. Electrical stimulation originating in the housing is led to the connector assembly through feedthrus. The connector assembly serves to transmit electrical signals out of the IPG and to a lead electrically connected to the connector assembly, the lead transmitting electrical signals between the IPG and patient tissue.
Other IEDs include implantable cardiac monitors (ICMs). ICMs also employ a housing, feedthrus, a header, and internal electrically conductive components of the header, such as, for example, antennas and sensing electrodes. ICMs are used to monitor heart function or other electrical signals, but do not administer electrotherapy.
Conventional processes for fabricating a header of an IED employ epoxy casting the header about the header's electrically conductor components and to the device after the feedthru has been welded to the device case. The epoxy casting process is a labor intensive process that requires significant secondary operations such as, for example, buffing, sanding and cleaning of the header and the housing. Such secondary processes require a dedicated wet room that is outside the cleanroom used in the assembly of the header to the housing.
There is a need in the art for an IED that is less expensive and labor intensive to manufacture.
SUMMARYDisclosed herein is an implantable electronic device. In one embodiment, the device includes a modular header-feedthru assembly and housing. The modular header-feedthru assembly includes a conductor assembly, a feedthru coupled to the conductor assembly, and a polymer header that was injected molded about the conductor assembly and at least a portion of the feedthru. The housing is welded to the feedthru.
The at least a portion of the feedthru may include a groove and the polymer header may fully occupy the groove in anchoring the polymer header to the feedthru. The groove may extend in a recessed manner horizontally and circumferentially about a base of the feedthru. The groove may have a recess depth of between approximately 0.01″ and approximately 0.03″, and a recess height of between approximately 0.01″ and approximately 0.03″.
The housing may enclose at least one of a battery or a hybrid. The welding between the housing and the feedthru may form a hermetic seal between the housing and the feedthru.
The feedthru may include a feedthru terminal that is in electrical communication with the conductor assembly and extends from the feedthru into a female electrical receptacle supported by the housing to make electrical contact with the female electrical receptacle. The female electrical receptacle may be in electrical communication with electronic components contained in the housing.
The feedthru terminal may be plugged into the female electrical receptacle. The female electrical receptacle may include a biasing member that biases against the feedthru terminal. The biasing member may include a funnel portion.
The polymer header may include a thermoplastic. The polymer header may include Tecothane and/or Pallathane.
The implantable electronic device may be an implantable cardiac monitor. The conductor assembly may include an electrode plate and a BLE antenna. The electrode plate may include an electrode surface in the form of a generally continuous flat surface. The electrode plate may include an electrode surface including at least one of bumps or recesses.
The implantable electronic device may be an implantable pulse generator. The conductor assembly may be in the form of a connector assembly including a ring block, a tip block, and/or an antenna. The implantable electronic device may also include an implantable medical lead configured to electrically couple with the implantable pulse generator.
Also disclosed herein is a method of manufacturing an implantable electronic device. In one embodiment, the method includes: direct injection mold a polymer material about a conductor assembly and an upper portion of a feedthru base to form a modular header-feedthru assembly; mate a bottom portion of the feedthru base with a top portion of a housing of the implantable electronic device; and weld the bottom portion of the feedthru base to the top portion of the housing.
The housing may enclose at least one of a battery or a hybrid. The welding between the top portion of the housing and the bottom portion of the feedthru base may form a hermetic seal between the housing and the feedthru.
The method may further include plugging a feedthru terminal into a female electrical receptacle to make electrical contact with the female electrical receptacle. The feedthru may include the feedthru terminal, which is in electrical communication with the conductor assembly. The feedthru terminal may extend from the feedthru into the female electrical receptacle, which may be supported by a hybrid that is supported by the housing such that it can be said that the female receptacle is operably coupled to the housing. The female electrical receptacle may be in electrical communication with electronic components contained in the housing.
The polymer material may include a thermoplastic. The polymer material may include at least one of Tecothane or Pallathane.
The implantable electronic device manufactured via the method may be an implantable cardiac monitor. The conductor assembly may include an electrode plate and a BLE antenna.
The implantable electronic device manufactured via the method may be an implantable pulse generator. The conductor assembly may be in the form of a connector assembly including at least one of a ring block, a tip block, or an antenna.
The feedthru may include a groove and the polymer material may be caused to fully occupy the groove in anchoring the polymer material to the feedthru. The groove may extend in a recessed manner horizontally and circumferentially about the feedthru base. The groove may have a recess depth of between approximately 0.01″ and approximately 0.03″, and a recess height of between approximately 0.01″ and approximately 0.03″.
While multiple embodiments are disclosed, still other embodiments of the present disclosure will become apparent to those skilled in the art from the following detailed description, which shows and describes illustrative embodiments of the disclosure. As will be realized, the invention is capable of modifications in various aspects, all without departing from the spirit and scope of the present disclosure. Accordingly, the drawings and detailed description are to be regarded as illustrative in nature and not restrictive.
Implementations of the present disclosure involve an implantable electronic device (IED) 20 such as an implantable cardiac monitor (ICM) or an implantable pulse generator (IPG). The IPG administers electrotherapy or other neurostimulation via an implantable lead having a lead connector end on a proximal end of the implantable lead. The IPG includes a housing or can and a connector assembly enclosed in a header to form a header connector assembly that is coupled to the housing or can. The header connector assembly has at least one lead connector receiving bore or receptacle that includes electrical contacts of the connector assembly that make electrical contact with corresponding electrical terminals on the lead connector end on the proximal end of the implantable lead when the lead connector end is plugged into or otherwise received in the lead connector receiving bore or receptacle. Via the electrical connection between the corresponding electrical terminals of the lead connector end and the electrical contacts of the lead connector receiving bore, electrical signals can be administered from the IPG and through the lead to patient tissue. Similarly, but in reverse, electrical signals originating in patient tissue can travel via the lead to the IPG to be sensed at the IPG.
The ICM is similar to the IPG in that it also includes a housing or can and a header. However, unlike the IPG, the ICM does not attach to leads and the ICM simply monitors electrical signals and does not administer therapy.
The implantable electronic device configurations and methods of assembly disclosed herein are advantageous for at least the reason that they save manufacturing costs. Specifically, the implantable electronic devices disclosed herein employ an advantageous modular assembly of an IED 20 that is able to take advantage of direct injection molding for the manufacture of a modular header-feedthru assembly 106, which can then be plugged into the device housing 24 and welded thereto. The resulting IED 20 are advantageous in that they have a robust configuration that has less associated manufacturing costs than those devices known in the art.
Before beginning a detailed discussion of the modular aspects of the IED 20 and the corresponding methods of manufacture, a general discussion is first given regarding features of a lead connector end at the proximal end of an implantable medical lead followed by a general discussion of the features of an IPG 20. A general discussion is then given regarding the features of an ICM 20, followed immediately thereafter by a detailed discussion of the modular aspects of the devices 20 and the related methods of manufacture.
A. Overview of a Lead Connector End and IPGAs is well known in the art, bipolar coaxial leads typically consists of a tubular housing of a biocompatible, biostable insulating material containing an inner multifilar conductor coil that is surrounded by an inner insulating tube. The inner conductor coil is connected to a tip electrode on the distal end of the lead. The inner insulating tube is surrounded by a separate, outer multifilar conductor coil that is also enclosed within the tubular housing. The outer conductor coil is connected to an anodal ring electrode along the distal end portion of the lead. The inner insulation is intended to electrically isolate the two conductor coils preventing any internal electrical short circuit, while the housing protects the entire lead from the intrusion of body fluids. These insulating materials are typically either silicone rubber or polyurethane. More recently, there have been introduced bipolar leads in which multifilar cable conductors contained within multilumen housings are substituted for the conductor coils in order to reduce even further the overall diameter of the lead.
The proximal lead end portion 10 shown in
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The various tabs are welded to corresponding terminals 100 of a feedthru 102 similar to that discussed below with respect to
As can be understood from the preceding discussion and as provided in greater detail below, the header-feedthru assembly 106 forms a first module that is plugged into electrical receptacles 104 of the housing 24, which forms a second module. The feedthru 102 of the header-feedthru assembly 106 is welded to the housing 24 to complete the assembly of the IPG 20 as it generally appears in
These concepts discussed above with respect to an IPG 20 will now be discussed with respect to an ICM 20.
B. Overview of an ICMAs can be understood from
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As discussed in detail below, once the header assembly 22 is completed such that the header 40 is injected molded about the electrically conductive components (e.g., in the case of an ICM 20, the electrically conductive components of the conductor assembly 42) and to the feedthru 102 to form a resulting modular header-feedthru assembly 106, the feedthru terminals 100 are plugged into electrical receptacles 104 located in the housing 24 of the IPG 20 similar to that discussed below with respect to
As can be understood from the preceding discussion and as provided in greater detail below, the header-feedthru assembly 106 forms a first module that is plugged into electrical receptacles 104 of the housing 24, which forms a second module. The feedthru 102 of the header-feedthru assembly 106 is welded to the housing 24 to complete the assembly of the ICM 20 as it generally appears in
To begin a discussion of the manufacture of the modular header-feedthru assembly 106 discussed above and its combination with a housing 24 to form an IED 20 that is either an IPG 20 (see
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In other embodiments, the biasing member 126 make take other forms such as, for example, a linearly extending spring-like member extending the length of the interior of the outer shell 128. The outer shell and the biasing member may be made from a variety of electrically conductive metals such as, stainless steel, platinum, platinum-iridium alloy, gold, beryllium copper, or etc.
As can be understood from
The above described IPG 20 and ICM 20 are advantageous in that they have a robust configuration that has less associated manufacturing costs than those devices known in the art. The above-described manufacturing method facilitates an advantageous modular assembly of an IED 20 that is able to take advantage of direct injection molding for the manufacture of a modular header-feedthru assembly 106, which can then be plugged into the device housing 24 and welded thereto.
The foregoing merely illustrates the principles of the invention. Various modifications and alterations to the described embodiments will be apparent to those skilled in the art in view of the teachings herein. It will thus be appreciated that those skilled in the art will be able to devise numerous systems, arrangements and methods which, although not explicitly shown or described herein, embody the principles of the invention and are thus within the spirit and scope of the present invention. From the above description and drawings, it will be understood by those of ordinary skill in the art that the particular embodiments shown and described are for purposes of illustrations only and are not intended to limit the scope of the present invention. References to details of particular embodiments are not intended to limit the scope of the invention.
Claims
1. An implantable electronic device comprising:
- a header-feedthru assembly comprising a feedthru base and a feedthru terminal extending through the feedthru base such that a first portion of the feedthru terminal extends beyond a bottom portion of the feedthru base; and
- a housing that contains a female electrical receptacle within a recess of the housing, wherein the housing includes a mating end that defines a cavity, the housing configured to receive at least the bottom portion of the feedthru base into the cavity and engage the feedthru base to guide the feedthru terminal into alignment with the female electrical receptacle as the header-feedthru assembly is plugged into the cavity for the feedthru terminal to enter into and electrically connect to the female electrical receptacle.
2. The implantable electronic device of claim 1, wherein an upper edge of the housing at the mating end is coupled to the feedthru base by a weld and the weld forms a hermetic seal between the upper edge of the housing and the feedthru base.
3. The implantable electronic device of claim 1, wherein the cavity is defined by an upper edge of the housing at the mating end, and the upper edge has a closed shape.
4. The implantable electronic device of claim 3, wherein the closed shape is oblong.
5. The implantable electronic device of claim 1, wherein a second portion of the feedthru terminal extends beyond an upper portion of the feedthru base, and the header-feedthru assembly further comprises a molded polymer header that is secured to the upper portion of the feedthru base and encases the second portion of the feedthru terminal.
6. The implantable electronic device of claim 5, wherein the molded polymer header comprises at least one of a thermoplastic polyurethane material or a thermoplastic polycarbonate material.
7. The implantable electronic device of claim 1, wherein the female electrical receptable is electrically coupled to internal electronic components within the housing, and the feedthru terminal is electrically coupled to a conductor assembly of the header-feedthru assembly,
- wherein receipt of the first portion of the feedthru terminal within the female electrical receptacle as the header-feedthru assembly is plugged into the cavity electrically connects the internal electronic components of the housing to the conductor assembly.
8. The implantable electronic device of claim 7, wherein the implantable electronic device is an implantable cardiac monitor and the conductor assembly comprises an electrode plate and an antenna that are each at least partially encased within a molded polymer header of the header-feedthru assembly.
9. The implantable electronic device of claim 7, wherein the implantable electronic device is an implantable pulse generator and the conductor assembly comprises at least one of a ring block or a tip block configured to receive and electrically connect to a lead of the implantable pulse generator, the at least one of the ring block or the tip block at least partially encased within a molded polymer header of the header-feedthru assembly.
10. The implantable electronic device of claim 1, wherein the female electrical receptacle is a first of plural female electrical receptacles secured in place within the recess of the housing and the feedthru terminal is a first of plural feedthru terminals coupled to and extending through the feedthru base, wherein the housing engages the feedthru base as the header-feedthru assembly is plugged into the cavity to guide the plural feedthru terminals into alignment with, and receipt into, different corresponding ones of the plural female electrical receptacles.
11. The implantable electronic device of claim 1, wherein the feedthru base includes a flange with a bottom edge, and the bottom edge of the flange is configured to abut against an upper edge of the housing at the mating end of the housing to block additional movement of the header-feedthru assembly into the cavity.
12. The implantable electronic device of claim 1, wherein the female electrical receptacle defines a cylindrical hole that is sized to receive the first portion of the feedthru terminal.
13. The implantable electronic device of claim 1, wherein the female electrical receptacle includes an outer shell and a biasing member within the outer shell, the biasing member configured to press against an outer surface of the first portion of the feedthru terminal that is received within the female electrical receptacle.
14. A method of manufacturing an implantable electronic device, the method comprising:
- coupling a feedthru terminal to a feedthru base such that the feedthru terminal extends through the feedthru base and a first portion of the feedthru terminal extends beyond a bottom portion of the feedthru base; and
- plugging the feedthru base, with the feedthru terminal coupled thereto, into a cavity at a mating end of a housing that contains a female electrical receptacle, wherein the mating end of the housing is configured to engage and guide the feedthru base such that the feedthru terminal aligns with, and is received into, the female electrical receptacle to electrically connect to the female electrical receptacle as the feedthru base is plugged into the cavity.
15. The method of claim 14, further comprising molding a polymer material to an upper portion of the feedthru base to form a polymer header on the feedthru base, wherein the polymer header encases a second portion of the feedthru terminal that extends beyond the upper portion of the feedthru base.
16. The method of claim 15, wherein the polymer material is molded to the feedthru base prior to plugging the feedthru base into the cavity of the housing, such that the polymer header is present on the feedthru base as the feedthru base is plugged into the cavity.
17. The method of claim 15, wherein the feedthru terminal is a first of plural feedthru terminals, and the coupling of the feedthru terminal comprises coupling the plural feedthru terminals to the feedthru base, wherein the method further comprises welding an electrode array and an antenna to the plural feedthru terminals prior to molding the polymer material to the upper portion of the feedthru base such that the polymer material at least partially encases the electrode array and the antenna.
18. The method of claim 15, wherein the molding of the polymer material is a direct injection process.
19. The method of claim 14, further comprising welding the feedthru base to the mating end of the housing after plugging the feedthru base into the cavity of the housing to form a hermetic seal between the housing and the feedthru base.
20. The method of claim 14, wherein the housing has an upper edge at the mating end, the upper edge having a closed shape and defining the cavity, wherein plugging the feedthru base into the cavity comprises aligning the feedthru base with the closed shape of the upper edge for the bottom portion of the feedthru base to be received within the cavity.
Type: Application
Filed: Sep 7, 2022
Publication Date: Jan 5, 2023
Inventors: Wisit Lim (Santa Clarita, CA), Reza Imani (Moorpark, CA), Brett Villavicencio (Valencia, CA), Mitch Goodman (Santa Clarita, CA)
Application Number: 17/930,092