Apparatus and method for delivering therapeutic and diagnostic agents

• US 7,211,041 B2
• Filed: 03/25/2005
• Issued: 05/01/2007
• Est. Priority Date: 05/07/1999
• Status: Expired due to Fees

• Current Assignee: Boston Scientific Scimed (Boston Scientific Corporation)
• Original Assignee: Boston Scientific Scimed (Boston Scientific Corporation)
• Inventors: Mueller, Richard
• Primary Examiner(s): CAMPBELL, THOR S
• Application Number:
  US11/090,859
• Publication Number:
  US 20050171474A1
• Time in Patent Office: 767 Days
• Field of Search: None
• US Class Current: 600/106
• CPC Class Codes: A61B 17/221 Gripping devices in the form of loops or baskets for gripping calculi or similar types of obstructions surgical snare instruments A61B17/32056
• CPC Class Codes: A61B 17/3207 Atherectomy devices working by cutting or abrading; Similar devices specially adapted for non-vascular obstructions A61B17/32037 takes precedence; endoscopic cutting instruments A61B17/320016
• CPC Class Codes: A61B 2017/00247 Making holes in the wall of the heart, e.g. laser Myocardial revascularization
• CPC Class Codes: A61B 2017/22077 with a part piercing the tissue A61B2017/22044 takes precedence
• CPC Class Codes: A61B 2017/22082 after introduction of a substance
• CPC Class Codes: A61B 2017/2212 having a closed distal end, e.g. a loop
• CPC Class Codes: A61B 2018/00392 Transmyocardial revascularisation
• CPC Class Codes: A61B 2090/064 for measuring force, pressure or mechanical tension
• 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 2210/125 Heart

Abstract

A drug-delivery tool and method for delivering a diagnostic or therapeutic agent to a target site within a selected body tissue, such as the myocardium of the heart, is disclosed. The drug-delivery tool generally includes an accessing device having a tissue-penetrating implement in its distal-end region, and elements for delivering a selected agent into a cavity formed by the implement. Methods of use are also described.

Claims

1. A method for delivering a selected diagnostic or therapeutic agent to a target site within a selected body tissue having a surface, comprising the steps of:

(a) providing a drug-delivery tool comprising

(i) an accessing device having distal and proximal ends, an inner lumen extending therebetween, a drug-delivery reservoir, and a user-control structure;

(ii) a tissue-penetrating implement carried on the distal end of the accessing device for axial movement in and out of the lumen, wherein the implement comprises a tip for penetrating the body tissue, and is operatively connected to the user-control structure; and

(iii) at least a first transducer located at the distal end of the accessing device;

(b) placing the distal end of the accessing device into contact with a selected body tissue surface;

(c) manipulating the orientation of the accessing device to a desired orientation, based on at least one signal from the first transducer;

(d) applying pressure to the selected body tissue surface with the distal end of the accessing device to create a seal;

(e) selectively actuating the tissue-penetrating implement to penetrate the selected body tissue surface; and

(f) delivering a drug while maintaining the seal.

2. The method of claim 1, wherein the desired orientation comprises placing the distal end of the accessing device substantially perpendicular to the selected body tissue surface.

3. The method of claim 1, wherein the distal end of the accessing tool is substantially circular and has a circumference, and wherein the first transducer is situated on the circumference of the distal end.

4. The method of claim 3, wherein the first transducer is in the shape of an annular ring.

5. The method of claim 3, wherein the tissue-penetrating implement is in fluid communication with the drug-delivery reservoir, and is configured to release the drug after penetrating a selected body tissue surface.

6. The method of claim 5, wherein the selected body tissue is a heart tissue, and wherein natural movements in the heart tissue can cause a drug to be released by the tissue-penetrating implement.

7. The method of claim 5, wherein the tissue-penetrating implement further comprises a cavity configured to store the drug.

8. The method of claim 5, wherein the tissue-penetrating implement does not receive a drug from the drug-delivery reservoir until after the completion of step (e).

9. The method of claim 1, wherein the tissue-penetrating implement in steps (b) and (c) is retracted within the lumen so that no portion of the tissue-penetrating implement extends beyond the distal end of the accessing device.

10. The method of claim 1, wherein the tissue-penetrating implement is configured to store the drug.

11. The method of claim 1, wherein the drug-delivery tool further comprises a second transducer.

12. The method of claim 1, wherein the first transducer is a pressure transducer.

13. The method of claim 1, wherein the first transducer is an ultrasound transducer.

14. A method for delivering a selected diagnostic or therapeutic agent to a target site within a selected body tissue having a surface, comprising the steps of:

(a) providing a drug-delivery tool comprising

(i) an accessing device having distal and proximal ends, an inner lumen extending therebetween, a drug-delivery reservoir, and a user-control structure;

(ii) a tissue-penetrating implement carried on the distal end of the accessing device and operatively connected to the user-control structure; and

(iii) at least a first transducer located at the distal end of the accessing device;

(b) placing the distal end of the accessing device into contact with a selected body tissue surface;

(c) manipulating the orientation of the accessing device to a desired orientation, based on at least one signal from the first transducer;

(d) applying pressure to the selected body tissue surface with the distal end of the accessing device to create a seal when the body tissue is in a diastolic state; and

(e) maintaining the seal while the body tissue is in a systolic state.

15. The method of claim 14, wherein a drug is released during the movement of the tissue between the diastolic state and the systolic state.

16. The method of claim 15, wherein the release of the drug is caused by the movement of the tissue from a diastolic state to a systolic state.

17. The method of claim 14, further comprising the step of selectively actuating the tissue-penetrating implement to penetrate the selected body tissue surface after step (d).