Alternate site gene therapy

• US 20040002677A1
• Filed: 12/11/2002
• Published: 01/01/2004
• Est. Priority Date: 12/11/2001
• Status: Active Grant

• Current Assignee: Boston Scientific Scimed, Inc. (Boston Scientific Corporation)
• Original Assignee: EKOS Corporation (Boston Scientific Corporation)
• Inventors: Gentsler, Curtis C.
• Granted Patent: US 7,141,044 B2
• Time in Patent Office: Days
• US Class Current: 604/22
• CPC Class Codes: A61B 17/12045 double occlusion, e.g. during anastomosis
• CPC Class Codes: A61B 17/2202 the ultrasound transducer being inside patient's body at the distal end of the catheter
• CPC Class Codes: A61B 2017/00969 used for transplantation
• CPC Class Codes: A61B 2017/12127 Double occlusion, e.g. for creating blood-free anastomosis site
• CPC Class Codes: A61B 2017/22038 with a guide wire
• CPC Class Codes: A61B 2017/22069 Immobilising; Stabilising
• CPC Class Codes: A61B 2017/22082 after introduction of a substance
• CPC Class Codes: A61B 2017/22088 ultrasound absorbing, drug activated by ultrasound
• CPC Class Codes: A61B 90/06 Measuring instruments not otherwise provided for
• CPC Class Codes: A61M 25/00 Catheters; Hollow probes dilators A61M29/00; peritoneal catheters A61M1/285; tracheal tubes A61M16/04; for drainage A61M27/00; for uterus, vagina or rectum A61M31/00 ; for measuring or testing A61B; materials for catheters A61L29/00
• CPC Class Codes: A61M 25/007 Side holes, e.g. their profiles or arrangements; Provisions to keep side holes unblocked
• CPC Class Codes: A61M 37/0092 using ultrasonic, sonic or infrasonic vibrations, e.g. phonophoresis

Abstract

A method is described for performing gene therapy at an alternate site when it is undesirable or impossible to perform gene therapy at the injured or diseased region. A gene therapy composition is administered using a catheter adapted to deliver ultrasound to facilitate uptake of the gene therapy composition into one or more cells at the alternate site. The treated section may then be transplanted to another region of the body which is diseased or injured.

Claims

1. A method for performing gene therapy on a selected section of a body lumen comprising:

placing within a selected section of the body lumen a catheter including one or more expandable members for occluding sections of the body lumen proximal and/or distal to the selected section;

occluding sections of the body lumen proximal and/or distal to the selected section of the body lumen;

delivering a gene therapy composition into the selected section of the body lumen;

delivering ultrasound to the selected section of the body lumen for a period of time in the presence of the gene therapy composition under conditions where the ultrasound causes cavitation of cells in the selected section; and

transplanting the selected section of the body lumen into another region of the body.

2. The method according to claim 1 wherein said selected section of the body lumen is highly vascularized.

3. The method according to claim 1 wherein said selected section of the body lumen is capable of anaerobic metabolism.

4. The method according to claim 1 wherein said selected section of the body lumen is highly vascularized and capable of anaerobic metabolism.

5. The method of claim 1, wherein the selected section of the body lumen is a blood vessel of leg skeletal muscle.

6. The method of claim 1, wherein the gene therapy composition comprises a gene operably linked to a promoter for expression in one or more cells within the selected section of the body lumen.

7. The method of claim 6, wherein the gene produces a gene product which reduces the immune response to grafts.

8. The method of claim 6, wherein the gene produces a gene product which blocks cell proliferation.

9. The method of claim 1, wherein the gene therapy composition comprises an oligonucleotide.