Method of interventional surgery

• US 6,860,867 B2
• Filed: 09/20/2001
• Issued: 03/01/2005
• Est. Priority Date: 09/20/2001
• Status: Expired due to Term

• Current Assignee: Regents of the University of California (University of California)
• Original Assignee: Regents of the University of California (University of California)
• Inventors: Pisano, Albert P., Seward, Kirk Patrick
• Primary Examiner(s): Lucchesi, Nicholas D.
• Assistant Examiner(s): Thompson, Michael M
• Application Number:
  US09/961,079
• Publication Number:
  US 20030055400A1
• Time in Patent Office: 1,258 Days
• Field of Search: 604/522, 604/41, 604/506, 604/507, 604/508, 604/509, 604/96.01, 604/97.01, 604/97.02, 604/98.01, 604/99.01, 604/103.01, 604/103.02, 604/103.07, 604/103.08, 604/104, 604/271, 604/272, 604/913, 600/431, 606/159, 606/170, 606/185, 606/190, 606/191, 606/194, 606/195
• US Class Current: 604/22
• CPC Class Codes: A61B 17/3478 Endoscopic needles, e.g. for infusion biopsy needles A61B10/0233; catheters with injection needles A61M25/0067
• CPC Class Codes: A61B 2017/00247 Making holes in the wall of the heart, e.g. laser Myocardial revascularization
• CPC Class Codes: A61B 2017/00345 Micromachines, nanomachines, microsystems
• CPC Class Codes: A61B 2017/00398 using powered actuators, e.g. stepper motors, solenoids
• CPC Class Codes: A61B 2017/22061 for spreading elements apart
• CPC Class Codes: A61B 2017/22075 with motorized advancing or retracting means
• CPC Class Codes: A61B 2018/00392 Transmyocardial revascularisation
• CPC Class Codes: A61M 2025/0086 the needles having bent tips, i.e. the needle distal tips are angled in relation to the longitudinal axis of the catheter
• CPC Class Codes: A61M 2025/0087 Multiple injection needles protruding laterally from the distal tip
• CPC Class Codes: A61M 2025/009 the needle having a bent tip, i.e. the needle distal tip is angled in relation to the longitudinal axis of the catheter
• CPC Class Codes: A61M 2025/0093 wherein at least one needle is a microneedle
• CPC Class Codes: A61M 2025/1086 having a special balloon surface topography, e.g. pores, protuberances, spikes or grooves
• CPC Class Codes: A61M 25/0084 being one or more injection needles

Abstract

A method of interventional surgery is described. The method may include inserting an actuator within a body of a vascularized organism and positioning the actuator adjacent a target region within a vessel of the body. The actuator is operated to cause a needle thereof to move in a substantially perpendicular direction relative to a wall of the vessel to produce an opening therein. A therapeutic or diagnostic agent may be delivered by the needle to the target region via the opening in the vessel wall.

Claims

1. A method of interventional surgery comprising:

inserting an actuator within a body of a vascularized organism and stopping the actuator adjacent a target region within a vessel of the vasculature of the body, the actuator including an expandable section incorporating a needle, the actuator being operable between an unactuated condition in which the expandable section is in a furled state and an actuated condition in which the expandable section is in an unfurled state;

causing the expandable section to change from the furled state to the unfurled state, to cause the needle to move in a substantially perpendicular direction relative to a wall of the vessel to produce an opening therein; and

delivering a therapeutic or diagnostic agent from the needle to the target region via the opening in the wall of the vessel.

2. The method of claim 1 wherein the therapeutic agent is selected from the group consisting of:

an inorganic pharmacological agent;

an organic pharmacological agent;

a cell with a treatment function including an undifferentiated, partially differentiated, or fully differentiated stem cell, an islet cell, or a genetically altered cell; and

an organic genetic material including a gene, a chromosome, a plasmid, DNA, RNA, mRNA, rRNA, tRNA, synthetic RNA, or synthetic DNA.

3. The method of claim 1 wherein the diagnostic agent is selected from the group consisting of:

a contrast medium, a radioactive marker, a fluorescent marker, an antibody marker, and an enzyme marker.

4. The method of claim 1 wherein the causing step includes supply an activating fluid to the actuator, and further including removing the activating fluid from the actuator to cause the expandable section to return to the furled state, thereby withdrawing the needle from the wall of the vessel.

5. The method of claim 1 wherein a proximal end of the actuator is joined to a lead end of a therapeutic catheter.

6. The method of claim 5 wherein a distal end of the actuator is joined to a tip end of the therapeutic catheter.

7. A method of interventional surgery comprising:

inserting an actuator within a body of a vascularized organism and stopping the actuator adjacent a target region within a vessel of the vasculature of the body, the actuator including an actuator body having a distal end and a proximal end, a central expandable section including a needle and located between the distal end and the proximal end, the actuator being operable between an unactuated condition in which the expandable section is in a furled state and an actuated condition in which the expandable section is in an unfurled state; and

operating the actuator to cause the expandable section to change from the furled state to the unfurled state such that the needle moves in an approximately perpendicular direction relative to a central longitudinal axis of the actuator body from a position inside the actuator body to a position outside the actuator body.

8. A method of catheter-based interventional surgery comprising:

inserting and manipulating a distal end of a catheter within a body of a vascularized organism, the distal end of the catheter including an actuator;

positioning the actuator adjacent a target region of a vessel of the vasculature of the body and terminating movement of the distal end of the catheter;

operating the actuator to cause an expandable section thereof to change from a furled state to an unfurled state such that a microneedle at the expandable section moves in a substantially perpendicular direction relative to a wall of the vessel, from a position inside a body of the actuator to a position outside the body of the actuator, to produce an opening in the wall of the vessel.

9. The method of claim 8 wherein a proximal end of the actuator is attached to a lead end of the catheter.

10. The method of claim 9 wherein a distal end of the actuator is attached to a tip end of the catheter.

11. The method of claim 8 further including supplying a therapeutic or diagnostic agent from the microneedle to the target region via the opening in the wall of the vessel.

12. The method of claim 11 wherein an activating fluid is supplied to the actuator to cause the expandable section to change from the furled state to the unfurled state.

13. The method of claim 12 further including removing the activating fluid from the actuator to cause the expandable section to return to the furled state.

14. The method of claim 13 wherein the activating fluid is a liquid.

15. A method of interventional surgery comprising:

inserting an actuator within a body and stopping the actuator adjacent a target region within a vessel of the vasculature of the body, the actuator being operable between an unactuated condition in which an expandable section thereof is in a furled state and an actuated condition in which the expandable section is in an unfurled state, and a plurality of needles at the expandable section; and

operating the actuator to cause the expandable section to change from the furled state to the unfurled state such that the needles move in an approximately perpendicular direction relative to a central longitudinal axis of the actuator from a position inside the actuator to a position outside the actuator.

16. The method of claim 15 wherein the needles are spaced along a length of the expandable section.

17. The method of claim 16 wherein when the expandable section changes from the furled state to the unfurled state, the plurality of needles move at substantially the same time.

18. The method of claim 16 wherein when the expandable section changes from the furled state to the unfurled state, at least one of the plurality of needles moves before another one of the plurality of needles.

19. The method of claim 15 wherein when the expandable section changes from the furled state to the unfurled state, at least one of the plurality of needles moves in a direction that is different from the direction of movement of another one of the plurality of needles.

20. A method of interventional surgery comprising:

inserting an actuator within a body of a vascularized organism and stopping the actuator adjacent a target region within a vessel of the vasculature of the body, the actuator including an expandable section, the actuator being operable between an unactuated condition in which the expandable section is in a furled state and an actuated condition in which the expandable section is in an unfurled state, and a needle at the expandable section; and

operating the actuator to cause the expandable section to change from the furled state to the unfurled state such that the needle moves from a position inside the actuator to a position outside the actuator.

21. The method of claim 20 further including providing a plurality of needles at the expandable section such that at least one of the needles moves in a direction that is different from the direction of movement of another one of the needles.