Method, device and kit for performing gene therapy

• US 6,135,976 A
• Filed: 09/25/1998
• Issued: 10/24/2000
• Est. Priority Date: 09/25/1998
• Status: Expired due to Term

• Current Assignee: EKOS Corporation (Boston Scientific Corporation)
• Original Assignee: EKOS Corporation (Boston Scientific Corporation)
• Inventors: Tachibana, Cozier, Hansmann, Douglas R.
• Primary Examiner(s): KENNEDY, SHARON E
• Application Number:
  US09/161,063
• Time in Patent Office: 760 Days
• Field of Search: 604/20-22, 604/96, 604/49, 604/101, 604/96.01, 604/101.01, 604/101.03, 604/101.05, 600/437, 600/462, 600/466, 600/467, 600/469, 600/470, 606/27-28, 607/96, 607/97
• US Class Current: 604/21
• CPC Class Codes: A61K 41/0028 Disruption, e.g. by heat or ultrasounds, sonophysical or sonochemical activation, e.g. thermosensitive or heat-sensitive liposomes, disruption of calculi with a medicinal preparation and ultrasounds
• CPC Class Codes: A61K 47/6957 the form being a device or a kit, e.g. stents or microdevices
• CPC Class Codes: A61M 2025/0057 Catheters delivering medicament other than through a conventional lumen, e.g. porous walls or hydrogel coatings
• CPC Class Codes: A61M 2025/105 having a balloon suitable for drug delivery, e.g. by using holes for delivery, drug coating or membranes
• CPC Class Codes: A61M 2025/1086 having a special balloon surface topography, e.g. pores, protuberances, spikes or grooves
• CPC Class Codes: A61M 25/1011 Multiple balloon catheters
• CPC Class Codes: A61M 37/0092 using ultrasonic, sonic or infrasonic vibrations, e.g. phonophoresis

Abstract

A catheter is provided for performing gene therapy on a selected section of a body lumen. The catheter comprises a distal catheter body including one or more expandable members for occluding sections of the body lumen proximal and/or distal to the selected section of the body lumen; a gene therapy composition delivery lumen connected to one or more gene therapy composition delivery ports at the distal catheter body for delivering a gene therapy composition to the selected section of the body lumen, the gene therapy composition delivery lumen housing a gene therapy agent; a washing lumen connected to one or more washing ports for delivering fluid to wash the selected section of the body lumen; and an ultrasound transducer for delivering ultrasound energy to the selected section of the body lumen.

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; and

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.

2. The method according to claim 1 wherein the catheter includes an expandable member for occluding a section of the body lumen proximal to the selected section of the body lumen, the method including occluding a section of the body lumen proximal to the selected section of the body lumen.

3. The catheter according to claim 1 wherein the catheter includes an expandable member for occluding a section of the body lumen distal to the selected section of the body lumen, the method including occluding a section of the body lumen distal to the selected section of the body lumen.

4. The method according to claim 1 wherein the catheter includes an expandable member for occluding a section of the body lumen proximal to the selected section of the body lumen and an expandable member for occluding a section of the body lumen distal to the selected section of the body lumen, the method including occluding sections of the body lumen proximal and distal to the selected section of the body lumen.

5. The method according to claim 1 wherein the method further includes the step of washing the selected section of the body lumen before delivering the gene therapy composition into the selected section of the body lumen.

6. The method according to claim 5 wherein the method further includes the step of delivering ultrasound during the washing step.

7. The method according to claim 1 wherein the method further includes the step of washing the selected section of the body lumen after delivering the gene therapy composition into the selected section of the body lumen in order to remove the gene therapy composition from the body lumen.

8. The method according to claim 7 wherein the method further includes the step of delivering ultrasound during the washing step.

9. The method according to claim 1 wherein the gene therapy agent is selected from the group consisting of DNA and RNA viral vectors and plasmids.

10. The method according to claim 1 wherein the gene therapy composition further includes a microbubble booster.

11. The method according to claim 1 wherein the gene therapy composition further includes a gene therapy carrier.

12. The method according to claim 1 wherein the step of delivering ultrasound is performed intermittantly with the step of delivering the gene therapy composition.

13. The method according to claim 12 wherein the step of delivering ultrasound intermittantly includes ceasing delivery of ultrasound for periods of time at least 0.1 second in duration.

14. The method according to claim 12 wherein the step of delivering ultrasound intermittantly includes ceasing delivery of ultrasound for periods of time sufficient for a bolus of the gene therapy composition to be delivered from a location in the catheter where the composition is not affected by the prior delivery of ultrasound to the selected section.