Device, system and method for interstitial transvascular intervention

• US 6,746,464 B1
• Filed: 10/28/1998
• Issued: 06/08/2004
• Est. Priority Date: 10/13/1995
• Status: Expired due to Term

• Current Assignee: Medtronic Vascular, Inc. (Medtronic Plc)
• Original Assignee: TransVascular, Inc. (Medtronic Plc)
• Inventors: Makower, Joshua
• Primary Examiner(s): REIP, DAVID OWEN
• Application Number:
  US09/181,701
• Time in Patent Office: 2,050 Days
• Field of Search: 606/11, 606/159, 606/108, 606/153-156, 606/184, 606/185, 600/16-18, 600/106, 600/107, 128/855, 604/164, 604/174, 604/95.01, 604/100.01, 604/103.01, 604/116, 604/117, 604/261, 604/506-513, 604/103.1
• US Class Current: 606/185
• CPC Class Codes: A61B 1/3137 for examination of the interior of blood vessels
• CPC Class Codes: A61B 17/00234 for minimally invasive surgery A61B17/0218, A61B17/0469, A61B17/12013, A61B17/1285, A61B17/29, A61B17/320016 take precedence
• CPC Class Codes: A61B 17/00491 Surgical glue applicators surgical adhesives A61L24/00; two-component delivery syringes A61M5/19
• CPC Class Codes: A61B 17/0057 Implements for plugging an opening in the wall of a hollow or tubular organ, e.g. for sealing a vessel puncture or closing a cardiac septal defect sutures A61B17/04; closing rectum or urethra near body surface A61F2/0009
• CPC Class Codes: A61B 17/0643 with separate closing member, e.g. for interlocking with staple
• CPC Class Codes: A61B 17/11 for performing anastomosis; Buttons for anastomosis
• CPC Class Codes: A61B 17/12022 Occluding by internal devices, e.g. balloons or releasable wires plugging an opening in the wall of an organ A61B17/0057; occluders for the cervical canal A61F6/146; vas deferens occluders A61F6/20
• CPC Class Codes: A61B 17/12045 double occlusion, e.g. during anastomosis
• CPC Class Codes: A61B 17/12109 in a blood vessel
• CPC Class Codes: A61B 17/12131 characterised by the type of occluding device
• CPC Class Codes: A61B 17/12136 Balloons
• CPC Class Codes: A61B 17/12181 formed by fluidized, gelatinous or cellular remodelable materials, e.g. embolic liquids, foams or extracellular matrices
• CPC Class Codes: A61B 17/1219 expandable in contact with liquids
• CPC Class Codes: A61B 17/320725 with radially expandable cutting or abrading elements A61B17/32075 takes precedence
• CPC Class Codes: A61B 17/3417 Details of tips or shafts, e.g. grooves, expandable, bendable; Multiple coaxial sliding cannulas, e.g. for dilating syringe needles A61M5/32; dilators A61M29/00
• CPC Class Codes: A61B 17/3496 Protecting sleeves or inner probes; Retractable tips for protecting body piercing guide needles A61M25/0612
• CPC Class Codes: A61B 18/00 Surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body eye surgery A61F9/007; ear surgery A61F11/00
• CPC Class Codes: A61B 18/1445 at the distal end of a shaft, e.g. forceps or scissors at the end of a rigid rod
• CPC Class Codes: A61B 18/1477 Needle-like probes
• 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 18/24 : with a catheter A61B18/26, A61B18/28 take precedence
• CPC Class Codes: A61B 2017/00243 : cardiac
• CPC Class Codes: A61B 2017/00247 : Making holes in the wall of the heart, e.g. laser Myocardial revascularization
• CPC Class Codes: A61B 2017/00252 : for by-pass connections, i.e. connections from heart chamber to blood vessel or from blood vessel to blood vessel
• CPC Class Codes: A61B 2017/003 : Steerable
• CPC Class Codes: A61B 2017/00504 : Tissue welding
• CPC Class Codes: A61B 2017/00641 : for closing fistulae, e.g. anorectal fistulae
• CPC Class Codes: A61B 2017/0641 : having at least three legs as part of one single body
• CPC Class Codes: A61B 2017/1107 : for blood vessels
• CPC Class Codes: A61B 2017/1139 : Side-to-side connections, e.g. shunt or X-connections
• 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 2017/22077 : with a part piercing the tissue A61B2017/22044 takes precedence
• CPC Class Codes: A61B 2017/306 : holding by means of suction
• CPC Class Codes: A61B 2017/347 : Locking means, e.g. for locking instrument in cannula
• CPC Class Codes: A61B 2017/3488 : Fixation to inner organ or inner body tissue
• CPC Class Codes: A61B 2018/00392 : Transmyocardial revascularisation
• CPC Class Codes: A61B 2018/00869 : Phase
• CPC Class Codes: A61B 2018/1425 : Needle
• CPC Class Codes: A61B 2090/378 : using ultrasound
• CPC Class Codes: A61B 2090/3925 : ultrasonic
• CPC Class Codes: A61B 2090/3929 : Active markers
• CPC Class Codes: A61B 2090/3958 : emitting a signal
• CPC Class Codes: A61B 90/361 : Image-producing devices, e.g. surgical cameras
• CPC Class Codes: A61B 90/40 : Apparatus fixed or close to patients specially adapted for providing an aseptic surgical environment
• CPC Class Codes: A61F 2/07 : Stent-grafts
• CPC Class Codes: A61F 2/2493 : Transmyocardial revascularisation [TMR] devices
• CPC Class Codes: A61F 2/90 : characterised by a net-like or mesh-like structure
• CPC Class Codes: A61F 2/95 : Instruments specially adapted for placement or removal of stents or stent-grafts
• CPC Class Codes: A61F 2002/30079 : magnetic
• CPC Class Codes: A61F 2002/8486 : provided on at least one of the ends
• CPC Class Codes: A61F 2210/009 : magnetic
• CPC Class Codes: A61M 2025/0076 : Unidirectional valves
• CPC Class Codes: A61M 2025/018 : Catheters having a lateral opening for guiding elongated means lateral to the catheter
• CPC Class Codes: A61M 2025/1052 : for temporarily occluding a vessel for isolating a sector

Abstract

Method and apparatus for utilizing the vascular system as a conduit to reach other vascular and extravascular locations within the body. Included are methods for revascularization wherein the extravascular passageways are formed to permit blood flow between vascular locations. Also included are methods for performing transvascular interstitial surgery (TVIS) wherein extravascular passageways are formed from a blood vessel to another vascular or non-vascular intracorporeal location. Also disclosed are devices usable for forming extravascular passageways in accordance with the invention, or for modifying, valving, maintaining or closing such passageways.

Claims

1. A catheter device for delivering a substance to a target site located outside of the lumen of a blood vessel;

a catheter that is advanceable into the blood vessel lumen;

a penetrator that is advanceable from the catheter;

a lumen extending through the penetrator; and

,

trajectory indicating apparatus for indicating the trajectory on which the penetrator will advance relative to the location of the target site, thereby enabling an operator to place the catheter in such position and rotational orientation within the blood vessel lumen that the penetrator will advance from the catheter, out of the blood vessel lumen to the target site.

2. A catheter device according to claim 1 wherein the trajectory indicating apparatus comprises a passive marker.

3. A catheter device according to claim 1 wherein the trajectory indicating apparatus comprises an active marker.

4. A catheter device of claim 1 wherein the trajectory indicating apparatus comprises a marker that may be sensed by a magnetic apparatus.

5. A catheter device according to claim 1 wherein the trajectory indicating apparatus comprises marker that may be imaged by a radiographic imaging apparatus.

6. A catheter device according to claim 1 wherein the trajectory indicating apparatus comprises a) an imageable marker which indicates the trajectory on which the penetrator will subsequently advance and b) imaging apparatus for concurrently imaging the target site and the imageable marker.

7. A catheter device according to claim 6 wherein the imageable marker is located on or in the catheter.

8. A catheter device according to claim 7 wherein both the imageable marker and the imaging apparatus are located on or in the catheter.

9. A catheter device according to claim 7 wherein the imageable marker is located on or in the catheter and the imaging device is not located on or in the catheter.

10. A catheter device according to claim 7 wherein the imaging device is located on or in the catheter and the imageable marker is not located on or in the catheter.

11. A catheter device according to claim 1 wherein the trajectory indicating apparatus is operative to sense flow within the target location.

12. A catheter device according to claim 1 wherein the trajectory indicating apparatus comprises a transmitter and receiver.

13. A catheter device according to claim 12 wherein one of the transmitter and receiver are positionable at the target site.

14. A catheter device according to claim 1 wherein the penetrator comprises a hollow needle through which the substance may be injected.

15. A catheter device according to claim 1 wherein the penetrator comprises a curved hollow needle through which the substance may be injected.

16. A method for delivering a substance to a target site located outside the lumen of a blood vessel, said method comprising the steps of:

A. providing a catheter device which comprises i) a catheter, ii) a penetrator that is advanceable from the catheter, iii) a lumen extending through the penetrator and, iv) trajectory indicating apparatus for indicating the trajectory on which the penetrator will advance relative to the location of the target site, thereby enabling an operator to place the catheter in such position and rotational orientation within the blood vessel lumen that the penetrator will advance from the catheter, out of the blood vessel lumen to the target site.

B. positioning the catheter device within the lumen of the blood vessel;

C. using the trajectory indicating apparatus to obtain an indication of the trajectory on which the penetrator will subsequently advance from the catheter;

D. making any necessary adjustments to the position and/or rotational orientation of the catheter within the blood vessel lumen to cause the indication of the trajectory on which the penetrator will subsequently advance from the catheter to indicate that when subsequently advanced the penetrator will enter the target site;

E. advancing the penetrator from the catheter, out of the blood vessel lumen and into the target site; and

,

E. infusing the substance through the lumen of the penetrator and into the target site.

17. A method according to claim 16 wherein the blood vessel is a vein.

18. A method according to claim 16 wherein the blood vessel is an artery.

19. A method according to claim 16 wherein the blood vessel is a coronary vein.

20. A method according to claim 16 wherein the blood vessel is a coronary artery.

21. A method according to claim 16 wherein the substance is a drug.