Apparatus and methods for stimulating revascularization and/or tissue growth

• US 6,120,520 A
• Filed: 03/17/1999
• Issued: 09/19/2000
• Est. Priority Date: 05/27/1997
• Status: Expired

• Current Assignee: Abbott Cardiovascular Systems Incorporated (Abbott Laboratories)
• Original Assignee: Angiotrax, Inc.
• Inventors: Saadat, Vahid, Ream, John H.
• Primary Examiner(s): Buiz, Michael
• Assistant Examiner(s): LEWIS, WILLIAM W
• Application Number:
  US09/271,094
• Time in Patent Office: 552 Days
• Field of Search: 606/1, 606/7, 606/14, 606/46, 606/159, 606/170
• US Class Current: 606/170
• 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 18/1492 having a flexible, catheter-like structure, e.g. for heart ablation A61B18/1477 takes precedence
• CPC Class Codes: A61B 2017/00022 Sensing or detecting at the treatment site
• CPC Class Codes: A61B 2017/00026 Conductivity or impedance, e.g. of tissue
• CPC Class Codes: A61B 2017/00106 ultrasonic
• CPC Class Codes: A61B 2017/00247 Making holes in the wall of the heart, e.g. laser Myocardial revascularization
• CPC Class Codes: A61B 2017/003 Steerable
• CPC Class Codes: A61B 2017/00398 using powered actuators, e.g. stepper motors, solenoids
• CPC Class Codes: A61B 2018/00196 reciprocating lengthwise
• CPC Class Codes: A61B 2018/00208 actively driven, e.g. by a motor
• CPC Class Codes: A61B 2018/00267 having a basket shaped structure
• CPC Class Codes: A61B 2018/00279 deployable
• CPC Class Codes: A61B 2018/00291 using suction
• CPC Class Codes: A61B 2018/00392 Transmyocardial revascularisation
• CPC Class Codes: A61B 2018/00738 Depth, e.g. depth of ablation
• CPC Class Codes: A61B 2018/00761 Duration
• CPC Class Codes: A61B 2018/00839 Bioelectrical parameters, e.g. ECG, EEG
• CPC Class Codes: A61B 2018/00916 with means for switching or controlling the main function of the instrument or device
• CPC Class Codes: A61B 2018/1435 Spiral
• CPC Class Codes: A61B 2018/1437 whereby the windings of the spiral touch each other such as to create a continuous surface
• CPC Class Codes: A61B 2018/1861 : with an instrument inserted into a body lumen or cavity, e.g. a catheter
• CPC Class Codes: A61B 2090/3782 : transmitter or receiver in catheter or minimal invasive instrument
• CPC Class Codes: A61B 2218/002 : Irrigation
• CPC Class Codes: A61B 2218/007 : Aspiration
• CPC Class Codes: A61B 34/20 : Surgical navigation systems; Devices for tracking or guiding surgical instruments, e.g. for frameless stereotaxis
• CPC Class Codes: A61B 8/0841 : for locating instruments
• CPC Class Codes: A61B 90/37 : Surgical systems with images on a monitor during operation
• CPC Class Codes: A61M 37/0069 : Devices for implanting pellets, e.g. markers or solid medicaments for introducing of radioactive sources for interstitial radiation therapy, i.e. brachytherapy A61N5/1027

Abstract

Apparatus and methods for stimulating revascularization and tissue growth are provided using an apparatus having a directable end region carrying a tissue piercing end effector. The apparatus optionally includes electrodes for depositing RF energy to form a controlled degree of scar tissue formation, means for delivering a controlled amount of a bioactive agent at the treatment site, or both.

Claims

1. Apparatus for treating an interior region of a cardiac chamber, the apparatus comprising:

a catheter configured for insertion into a cardiac chamber, the catheter having a deflectable end region;

an end effector disposed within the deflectable end region, the end effector adapted to form a needle track at a treatment site in an interior region of the cardiac chamber, the end effector movable between a first position, wherein the end effector is retracted within the end region, and a second position, wherein the end effector is extended beyond a distal endface of the catheter; and

means for moving the end region between the first and second positions,

wherein the end effector further comprises means for depositing a controlled amount of a bioactive agent at the treatment site.

2. The apparatus of claim 1 wherein the end effector comprises a non-coring sharpened tip.

3. The apparatus of claim 1 wherein the end effector further comprises an electrode adapted to deliver RF energy to the treatment site.

4. The apparatus of claim 1 wherein the end effector further comprises a plurality of fine wires, the fine wires movable between a retracted position and an extended position, the plurality of fine wires forming a matrix of additional needle tracks at the treatment site when extended.

5. The apparatus of claim 1 wherein the end effector is coupled to a drive shaft, the apparatus further comprising a controller including a hydraulic mechanism coupled to the drive shaft to extend and retract the end effector.

6. The apparatus as defined in claim 1 wherein the end effector is coupled to a drive shaft, the apparatus further comprising a controller including a pneumatic mechanism coupled to the drive shaft to extend and retract the end effector.

7. The apparatus as defined in claim 1 wherein the end effector is coupled to a drive shaft, the apparatus further comprising a manually actuated mechanism coupled to the drive shaft to extend and retract the end effector.

8. Apparatus for treating an interior region of a cardiac chamber, the apparatus comprising:

a catheter having a deflectable end region;

an end effector adapted to form a needle track at a treatment site in an interior region of the cardiac chamber, the end effector movable between a first position, wherein the end effector is retracted within the end region, and a second position, wherein the end effector is extended beyond a distal endface of the catheter; and

means for depositing a bioactive agent in the needle track when the end effector is in the second position.

9. The apparatus of claim 8 wherein the end effector comprises a non-coring sharpened tip.

10. The apparatus of claim 8 wherein the end effector further comprises an electrode adapted to deliver RF energy to the treatment site.

11. The apparatus of claim 10 wherein the bioactive agent is a fluid and the means for depositing comprises supplies the fluid to the end effector under pressure.

12. The apparatus of claim 8 wherein bioactive agent has a pellet form and the means for depositing the bioactive agent comprises a push rod.

13. A method of treating an interior region of a cardiac chamber comprising:

providing apparatus having a catheter adapted for insertion into a cardiac chamber, the catheter having a deflectable end region including an end effector adapted to form a needle track at a treatment site in an interior region of the cardiac chamber;

inserting the apparatus within a cardiac chamber;

deflecting the end region to dispose the end effector at a selected orientation relative to an endocardial surface;

actuating the end effector to form a needle track in an interior region of the cardiac chamber at a treatment site; and

delivering a controlled amount of a bioactive agent at the treatment site.

14. The method of claim 13 further comprising delivering RF energy to the treatment site to create a controlled depth of necrosis at the treatment site.

15. The method of claim 13 wherein delivering a controlled amount of a bioactive agent at the treatment site further comprises injecting the bioactive agent under pressure sufficient to form a pocket of bioactive agent in the tissue.

16. The method of claim 13 wherein delivering a controlled amount of a bioactive agent at the treatment site further comprises injecting a pellet comprising a bioactive agent.

17. The method as defined in claim 13 wherein the end effector further comprises a plurality of fine wires, the fine wires movable between a retracted position and an extended position, the method further comprising extending the plurality of fine wires to form a matrix of additional needle tracks at the treatment site.

18. The method as defined in claim 13 further comprising, following delivering a controlled amount of a bioactive agent at the treatment site:

translating the end region to relocate the end effector; and

repeating actuation of the end effector.