System and method for genetically treating cardiac conduction disturbances

• US 7,094,201 B1
• Filed: 08/18/1999
• Issued: 08/22/2006
• Est. Priority Date: 07/17/1996
• Status: Expired due to Fees

• Current Assignee: Medtronic Incorporated (Medtronic Plc)
• Original Assignee: Medtronic Incorporated (Medtronic Plc)
• Inventors: Morissette, Josée, Stokes, Kenneth B.
• Primary Examiner(s): WEHBE, ANNE MARIE SABRINA
• Application Number:
  US09/376,317
• Time in Patent Office: 2,561 Days
• Field of Search: 435/69.1, 435/320.1, 514/44, 604/24, 604/28, 604/93, 604/96, 607/9, 607/119, 607/120, 607/122
• US Class Current: 600/120
• CPC Class Codes: A61K 38/1709 from mammals
• CPC Class Codes: A61K 48/00 Medicinal preparations containing genetic material which is inserted into cells of the living body to treat genetic diseases; Gene therapy
• CPC Class Codes: A61K 48/0075 characterised by an aspect of the delivery route, e.g. oral, subcutaneous
• CPC Class Codes: A61M 2025/0089 Single injection needle protruding axially, i.e. along the longitudinal axis of the catheter, from the distal tip
• CPC Class Codes: A61M 5/3291 Shafts with additional lateral openings
• CPC Class Codes: C07K 14/705 Receptors; Cell surface antigens; Cell surface determinants tumour specific antigens C07K14/4748

Abstract

The present invention provides delivery systems for and methods of delivering conduction protein genetic material to cardiac cells in localized areas of the heart to improve the conductance therein. More specifically, there is provided a system and method for delivering connexin proteins or nucleic acid molecules encoding connexin proteins to a site in the heart which has been determined by mapping procedures to have a conduction disturbance. For cases where conduction is impaired, selected genetic material is delivered to cells around the disturbance area, in order to enhance overall conductivity patterns; in other cases, genetic material is selected to slow conduction in affected areas, so as to prevent, e.g., brady-tachy syndrome.

Claims

1. An implantable delivery system for delivering doses of genetic material to cardiac tissue, comprising:

recombinant nucleic acid vectors encoding a conduction protein selected from the group Cx40, Cx43, and Cx45;

a catheter, said catheter having a distal tip portion for engaging the cells of said cardiac tissue and delivering thereto said recombinant nucleic acid vectors;

a reservoir means for holding said recombinant nucleic acid vectors, said reservoir means located proximal to the said distal tip portion of said catheter; and

a delivery means for delivering and transfecting or transducing a therapeutically effective amount of said recombinant nucleic acid vectors from said reservoir means through said distal tip portion of said catheter to said cardiac tissue such that said cardiac tissue is transfected or transduced with said recombinant nucleic acid vectors;

wherein said catheter additionally comprises a mapping electrode means, a pacing electrode means, and a conductor means for connecting said mapping electrode means and a pacing electrode means to the proximal end of said catheter; and

wherein said mapping electrode means provides the means of determining the location of said cardiac tissue deficient in connexin expression for transfection or transducing said cells in said cardiac tissue and wherein said pacing electrode means provides means for testing or controlling the effect of the expression of said recombinant nucleic acid vectors with a pacemaker.