Method and apparatus for treatment of cardiac disorders

• US 8,500,720 B2
• Filed: 05/09/2005
• Issued: 08/06/2013
• Est. Priority Date: 05/09/2005
• Status: Active Grant

• Current Assignee: Medtronic Incorporated (Medtronic Plc)
• Original Assignee: Medtronic Incorporated (Medtronic Plc)
• Inventors: Keimel, John G.
• Primary Examiner(s): Sirmons, Kevin C
• Assistant Examiner(s): GILBERT, ANDREW M
• Application Number:
  US11/124,984
• Publication Number:
  US 20060251641A1
• Time in Patent Office: 3,011 Days
• Field of Search: 604/890.1, 604/891.1, 604/892.1
• US Class Current: 604/891.1
• CPC Class Codes: A61K 31/713 Double-stranded nucleic acids or oligonucleotides
• CPC Class Codes: A61K 38/00 Medicinal preparations containing peptides peptides containing beta-lactam rings A61K31/00; cyclic dipeptides not having in their molecule any other peptide link than those which form their ring, e.g. piperazine-2,5-diones, A61K31/00; ergot alkaloids of the cyclic peptide type A61K31/48; containing macromolecular compounds having statistically distributed amino acid units A61K31/74; medicinal preparations containing antigens or antibodies A61K39/00; medicinal preparations characterised by the non-active ingredients, e.g. peptides as drug carriers, A61K47/00
• CPC Class Codes: A61K 38/47 acting on glycosyl compounds (3.2), e.g. cellulases, lactases
• CPC Class Codes: A61M 2210/125 Heart
• CPC Class Codes: A61M 39/0208 Subcutaneous access sites for injecting or removing fluids transcutaneous access sites A61M39/0247; implantable infusion devices A61M5/14276
• CPC Class Codes: A61M 39/04 having pierceable self-sealing members
• CPC Class Codes: A61M 5/14276 specially adapted for implantation
• CPC Class Codes: A61M 5/172 electrical or electronic A61M5/16804, A61M5/16831 take precedence

Abstract

The present invention is directed to systems and methods for delivering therapy for a cardiac disorder, wherein the system comprises a source for supplying a protein formulation containing a protein that is otherwise deficient in cardiac cells in a patient with a cardiac disorder, and a catheter having a proximal end and a distal end for delivering the protein formulation to the pericardial sac region of a human heart.

Claims

1. A method comprising:

diagnosing a patient as having a cardiac disorder caused by a protein deficiency due to a gene mutation, the disorder being selected from the group consisting of glycogen storage disease Type II and Fabry disease;

injecting a therapeutic protein formulation into an implantable source, the therapeutic protein formulation comprising a protein in a form that is deficient in cardiac cells in the patient with the cardiac disorder, the protein being selected from lysosomal acid α

-glucosidase and α

-galactosidase;

determining a rate for delivering the therapeutic protein formulation based on the genetic sequence of the patient'"'"'s gene encoding the deficient protein; and

delivering the therapeutic protein formulation from the source through an implantable catheter directly to a pericardial sac region of a heart of a patient,

wherein the source is an implantable pump that provides for a programmable delivery rate of the protein formulation, and wherein the protein formulation is delivered at the determined delivery rate.

2. The method of claim 1, wherein integrity and activity of the protein formulation is maintained by adding to the protein formulation, at least one species operable for maintaining a desired pH.

3. The method of claim 1, wherein the pump includes a refillable reservoir to store the protein formulation prior to delivery to the pericardial sac.

4. The method of claim 1, wherein the disorder is glycogen storage disease Type II and the protein is lysosomal acid α

-glucosidase.

5. The method of claim 1, wherein the disease is Fabry disease and the protein is α

-galactosidase.