Systems and methods for attaching pre-fabricated header connector assembly to housing of implantable electronic device

{
  "publication_number": "US9687661B2",
  "country": "US",
  "kind": "B2",
  "title": "Systems and methods for attaching pre-fabricated header connector assembly to housing of implantable electronic device",
  "abstract": "Implementations of the present disclosure may take the form of an implantable electronic device such as an implantable pulse generator for administering electrotherapy via an implantable medical lead configured to couple with the implantable pulse generator, or an implantable cardiac monitor. The implantable electronic device includes a housing, a header connector assembly and a sealing member. The header connector assembly includes a connector assembly and a header enclosing the connector assembly. The sealing member is sandwiched between the header connector assembly and the housing.",
  "claims": [
    "1. An implantable electronic device comprising: a housing having a top surface; a header connector assembly comprising a connector assembly and a header enclosing the connector assembly, the header connector assembly having a bottom surface; and a sealing member formed into an elongated body having an inner surface, the sealing member insertable between the header connector assembly and the housing, the elongated body of the sealing member extending along a peripheral boundary of an area interfacing between the header connector assembly and the housing, an assembly of the housing, the header connector assembly, and the sealing member creating a backfill volume defined by the top surface of the housing, the bottom surface of the header connector assembly, and the inner surface of the elongated body.",
    "2. The implantable electronic device of claim 1, wherein the header connector assembly comprises a groove in which the sealing member at least partially resides when inserted between the header connector assembly and the housing.",
    "3. The implantable electronic device of claim 2, wherein the groove is defined in the header of the header connector assembly.",
    "4. The implantable electronic device of claim 1, wherein the top surface of the housing comprises a groove in which the sealing member at least partially resides when inserted between the header connector assembly and the housing.",
    "5. The implantable electronic device of claim 1, wherein the sealing member extends along the entirety of the peripheral boundary continuous and uninterrupted.",
    "6. The implantable electronic device of claim 1, further comprising a backfill material located in the backfill volume.",
    "7. The implantable electronic device of claim 1, wherein the header connector assembly comprises a peripheral rim including a groove in which sealing member resides.",
    "8. The implantable electronic device of claim 1, wherein the housing comprises a peripheral rim including a groove in which sealing member resides.",
    "9. The implantable electronic device of claim 1, wherein the sealing member comprises at least one of a scone elastomer, a thermoplastic, elastomer, or a solvent based adhesive.",
    "10. The implantable device of claim 1, wherein the implantable electronic device comprises an implantable pulse generator for administering electrotherapy via an implantable medical lead configured to couple with the implantable pulse generator.",
    "11. The implantable device of claim 1, wherein the implantable electronic device comprises an implantable cardiac monitor.",
    "12. A method of manufacturing an implantable electronic device, the method comprising: a) sandwiching a sealing member having an elongated body between a housing and a header connector assembly, the elongated body of the sealing member extending along a peripheral boundary of an area interfacing between the header connector assembly and the housing; and b) backfilling between a top surface of the housing, a bottom surface of the header connector assembly, and an inner surface of the elongated body of the sealing member with a backfill material, the sealing member preventing leaking of the backfill material.",
    "13. The method of claim 12, further comprising and subsequent to step a) and prior to step b), welding components of a connector assembly of the header connector assembly to components of a feedthru of the housing.",
    "14. The method of claim 12, wherein the header connector assembly comprises a groove in which the sealing member at least partially resides when sandwiched between the header connector assembly and the housing.",
    "15. The method of claim 12, wherein a top surface of the housing comprises a groove in which the sealing member at least partially resides when sandwiched between the header connector assembly and the housing.",
    "16. The method of claim 12, wherein the header connector assembly is pre-manufactured prior to being used to sandwich the sealing member between the housing and header connector assembly.",
    "17. The method of claim 12, wherein the sealing member is a pre-manufactured part having the same geometry as a groove in which the sealing member is received prior to being sandwiched between the header connector assembly and the housing.",
    "18. The method of claim 17, wherein the sealing member comprises at least one of a silicone elastomer, a thermoplastic elastomer, or a solvent based adhesive.",
    "19. The method of claim 12, wherein the sealing member is deposited into a groove as a silicone rubber based liquid or gel, the groove being part of at least the header connector assembly or the housing, the scone based liquid or gel being fully cured before the sealing member is sandwiched between the header connector assembly and the housing.",
    "20. The method of claim 12, wherein the sealing member is deposited into a groove as a silicone rubber based liquid or gel, the groove being part of at least the header connector assembly or the housing, the silicone based liquid or gel not yet being fully cured before the sealing member is sandwiched between the header connector assembly and the housing.",
    "21. The method of cam 12, wherein the sealing member is deposited into a groove as a solvent based adhesive, the groove being part of at least the header connector assembly or the housing, the solvent based adhesive not yet being fully cured before the sealing member is sandwiched between the header connector assembly and the housing.",
    "22. The method of claim 12, wherein the implantable electronic device comprises an implantable pulse generator for administering electrotherapy via an implantable medical lead configured to couple with the implantable pulse generator.",
    "23. The method of claim 12, wherein the implantable electronic device comprises an implantable cardiac monitor."
  ],
  "description_excerpt": "Aspects of the present invention relate to medical apparatus and methods. More specifically, the present invention relates to systems and methods for attaching a pre-fabricated header connector assembly to a housing of an implantable electronic device such as an implantable pulse generator or implantable cardiac monitor.\n\nImplantable 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, commonly include a housing, feedthrus, and a connector assembly that is enclosed in a header. 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.\n\nOther implantable electronic devices such as, for example, implantable cardiac monitors (ICMs) also employ a housing and a header. ICMs are used to monitor heart function or other electrical signals, but do not administer electrotherapy.\n\nCurrent header casting manufacturing processes and the associated methods of assembling the header and its enclosed connector assembly onto the housing require multiple operations, are skill intensive, and unavoidably time consuming.",
  "cpc": [
    "A61B 5/686",
    "A61B 2562/22",
    "A61B 5/0402",
    "A61B 5/318",
    "A61N 1/375",
    "A61N 1/37512",
    "A61N 1/3752",
    "A61N 1/3968"
  ],
  "ipc": [
    "A61B 5/00",
    "A61N 1/375",
    "A61B 5/02",
    "A61B 5/0402"
  ],
  "assignees": [
    "Pacesetter Inc"
  ],
  "inventors": [
    "Dino Bortolin",
    "Ekaterina Tkatchouk",
    "Christopher R. Jenney"
  ],
  "filing_date": "2015-08-28",
  "publication_date": "2017-06-27",
  "grant_date": "2017-06-27",
  "priority_date": "2015-08-28",
  "application_number": "US-201514839750-A",
  "family_id": "58103529",
  "cited_by_count": 8,
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}