Stabilized tissue penetrating catheters

• US 6,726,677 B1
• Filed: 03/29/2000
• Issued: 04/27/2004
• 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: Flaherty, J. Christopher, Makower, Joshua
• Primary Examiner(s): Jaworski, Francis J.
• Application Number:
  US09/538,119
• Time in Patent Office: 1,490 Days
• Field of Search: 604/95-99, 604/528, 604/41-42, 604/500, 604/506-510, 606/159, 606/169-171, 600/439, 600/462-471, 623/1
• US Class Current: 604/528
• 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 17/12136 Balloons
• CPC Class Codes: A61B 17/12172 having a pre-set deployed three-dimensional shape methods of manufacturing A61B2017/00526
• 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 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 2017/00455 : Orientation indicators, e.g. recess on the handle
• 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 2017/1107 : 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 2017/22069 : Immobilising; Stabilising
• CPC Class Codes: A61B 2017/22072 : with an instrument channel, e.g. for replacing one instrument by the other in cannulas A61B17/3417
• 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 2090/3784 : both receiver and transmitter being in the instrument or receiver being also transmitter
• 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 8/12 : in body cavities or body tracts, e.g. by using catheters catheters per se A61M25/00
• CPC Class Codes: A61B 8/445 : Details of catheter construction
• CPC Class Codes: A61B 8/4488 : the transducer being a phased array
• CPC Class Codes: A61B 90/361 : Image-producing devices, e.g. surgical cameras
• CPC Class Codes: A61B 90/39 : Markers, e.g. radio-opaque or breast lesions markers
• 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 2/9517 : handle assemblies therefor
• 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: A61K 31/195 : having an amino group
• 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
• CPC Class Codes: A61M 25/0147 : with movable mechanical means, e.g. pull wires
• CPC Class Codes: A61M 25/0155 : with hydraulic or pneumatic means, e.g. balloons or inflatable compartments
• CPC Class Codes: A61M 29/02 : Dilators made of swellable material balloon catheters for angioplasty A61M25/104

Abstract

A tissue penetrating catheter that is usable to advance a tissue penetrator from within a blood vessel, through the wall of the blood vessel to a target location. The catheter includes at least one stabilizing device thereon for stabilizing catheter prior to advancing the tissue penetrator. The tissue penetrator may extend through a lumen in the body of the catheter and project transversely through an exit port. The stabilizing device may be located closely adjacent to the exit port, or may surround the exit port. The stabilizing device may be one or more balloons, or other mechanical structure that is expandable into contact with the inner luminal wall of the blood vessel. Desirably, the exit port is forced into contact with the blood vessel wall to shorten the distance that the tissue penetrator projects from the catheter body to the target location. The catheter is particular useful for forming blood flow tracts between blood vessels, in particular in coronary revascularization procedures. Methods of utilizing such a catheter to bypass an arterial obstruction is also disclosed.

Claims

1. A catheter device for penetrating through the wall of a vessel within a patient'"'"'s body to a target location outside of that vessel, said device comprising:

a. a catheter body having a proximal end and a distal end, the catheter body being advanceable into the vessel;

b. a tissue penetrator that is passable from the catheter body, through the wall of the vessel and to the target location outside the vessel;

c. catheter orientation apparatus comprising at least one of i) an imageable marker indicative of the trajectory along which the tissue penetrator will advance from the catheter body and ii) an imaging apparatus for imaging at least the target location relative to an indication of the trajectory along which the tissue penetrator will advance from the catheter body, so as to enable an operator to rotationally orient the catheter body in the vessel such that subsequent advancement of the tissue penetrator from the catheter body will cause the tissue penetrator to enter the target location; and

,

d. a stabilizer that is radially extendable from the catheter body to deter at least some movement of the catheter body within the vessel as the penetrator penetrates through the wall of the blood vessel.

2. The catheter of claim 1, wherein the stabilizer is expandable.

3. The catheter of claim 2, wherein the stabilizer comprises an apparatus selected from the group consisting of:

at least one balloon;

at least one cage structure that is deployable laterally from the catheter body;

at least one member that is deployable laterally from the catheter body; and

,

a portion of the catheter body that is initially in a first non-stabilizing configuration and is subsequently transitionable to a stabilizing configuration.

4. The catheter of claim 3, wherein the stabilizer expands concentrically about the catheter body.

5. The catheter of claim 4, wherein the stabilizer is located within a distance no greater than about three times the diameter of the catheter from a location at which the penetrator exits the catheter body.

6. The catheter of claim 4, wherein the stabilizer substantially surrounds a location at which the penetrator exits the catheter body and wherein a penetrator passageway is formed in the stabilizer to permit the tissue penetrator to pass therethrough.

7. The catheter of claim 3, wherein the stabilizer expands non-concentrically about the catheter body such that a location at which the penetrator exits the catheter body is located closely adjacent to or in contact with the blood vessel wall when the stabilizer is expanded.

8. The catheter of claim 7, wherein the stabilizer extends axially on both sides of a location at which the penetrator exits the catheter body.

9. The catheter of claim 1, wherein the stabilizer device comprises a shape memory alloy element that is initially disposed in a first configuration whereby the stabilizer is not deployed and is subsequently transitionable to a second configuration whereby the stabilizer is deployed.

10. The catheter of claim 1, wherein the stabilizer comprises at least two stabilizer members provided on the catheter, at least one of said stabilizer members being proximal to and at least one of said stabilizer members being distal to a location at which the penetrator exits the catheter body.

11. The catheter of claim 1, wherein the stabilizer is further constructed to straighten a portion of the catheter body when the stabilizer is deployed.

12. The catheter of claim 1, wherein the stabilizer is constructed and deployed in a manner that allows some body fluid to flow through the vessel, past the stabilizer, when the stabilizer is deployed.

13. The catheter of claim 1 wherein the orientation apparatus comprises at least one penetrator direction marker is formed on the stabilizer, said at least one penetrator direction marker being useable in conjunction with an imaging device, to orient the catheter body within the vessel such that the penetrator will pass into the target location.

14. The catheter of claim 13 wherein the at least one penetrator direction marker is formed on the stabilizer at a location that is radially opposite the location at which the penetrator passes from the catheter body.

15. The catheter of claim 13 wherein the at least one penetrator direction marker is imageable by an imaging apparatus positioned outside of the patient'"'"'s body.

16. The catheter of claim 13 wherein the at least one penetrator direction marker is imageable by an imaging apparatus positioned on or in the catheter.

17. The catheter of claim 16 wherein the orientation apparatus of the catheter further comprises a lumen for receiving an imaging apparatus therewithin such that the imaging apparatus may image the target location and the at least one penetrator direction marker.

18. The catheter of claim 16 wherein the orientation apparatus of the catheter comprises an imaging apparatus mounted in the catheter, said imaging apparatus being useable to image the target location and the at least one penetrator direction marker.