Catheter apparatus for guided transvascular treatment of arterial occlusions

• US 6,241,667 B1
• Filed: 01/15/1998
• Issued: 06/05/2001
• Est. Priority Date: 01/15/1998
• Status: Expired due to Term

• Current Assignee: Cardinal Health Switzerland 515 GmbH (Cardinal Health, Inc.)
• Original Assignee: LuMend, Inc. (Cardinal Health, Inc.)
• Inventors: Hinohara, Tomoaki, Vetter, James W., Milo, Charles F., Selmon, Matthew R.
• Primary Examiner(s): Lateef, Marvin M.
• Assistant Examiner(s): MANTIS MERCADER, ELENI M
• Application Number:
  US09/008,198
• Time in Patent Office: 1,237 Days
• Field of Search: 600/427, 600/424, 600/433-435, 600/407, 606/151-156, 606/189, 606/198, 128/898, 604/96, 604/104, 604/164, 623/1, 623/2
• US Class Current: 600/407
• 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 17/320758 with a rotating cutting instrument, e.g. motor driven A61B17/320725, A61B17/32075 and A61B17/320783 take precedence; for removing intra-ocular material A61F9/00763; endoscopic rotatable cutting instruments A61B17/32002
• 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 2017/22077 with a part piercing the tissue A61B2017/22044 takes precedence
• CPC Class Codes: A61B 2017/308 with suction cups
• CPC Class Codes: A61B 2017/320004 abrasive
• CPC Class Codes: A61B 2017/320044 Blunt dissectors blunt suture needles A61B2017/06085
• CPC Class Codes: A61B 2018/00392 Transmyocardial revascularisation
• CPC Class Codes: A61B 2090/3784 both receiver and transmitter being in the instrument or receiver being also transmitter
• 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: A61M 2025/1097 with perfusion means for enabling blood circulation only while the balloon is in an inflated state, e.g. temporary by-pass within balloon
• CPC Class Codes: A61M 25/0147 with movable mechanical means, e.g. pull wires

Abstract

An apparatus is described for treating arterial occlusions combining an intraluminally operable catheter having an occlusion-crossing working element, with an extraluminally operable locator for imaging the progress of the working element through the occlusion. Suction coupling means are described for removably anchoring the locator to a surface proximate the heart. A method for treating arterial occlusions is described in which the distal end of the catheter shaft exits a lumen of the locator, penetrates the arterial wall distal to the occlusion, crosses the occlusion retrograde and passes into a separately introduced standard intravascular catheter, whereupon the distal end of the shaft may be manipulated from the proximal end of the standard catheter. The proximal end of the shaft is then released from external attachments and drawn into the artery to perform treatment or guiding functions. Spatial interrelationships are observed real-time via the locator. Conical, abrasive, blunt-dissecting, sharp-pointed and guide-wire type working elements, steerable and non-steering, are described. Acoustic transducers and a flexible imaging tube are described for the locator. A signal-emitting working element and cooperating signal-receiving locator are described.

Claims

1. An apparatus for treating arterial occlusions, comprising:

a locator for extraluminal placement proximate to an arterial occlusion, wherein the locator includes an imaging tube having a proximal end zone, a distal end zone, a lumen therebetween, and an imaging device operatively disposed in the imaging tube; and

an elongated flexible catheter shaft disposed in the lumen of the imaging tube that is formed with a a distal end zone, wherein the distal end zone of the catheter shaft include a working element that is transvascularly operable upon the occlusion in view of spatial information provided by the locator, and wherein the working element further includes a tissue-penetrating wire at least partially disposed within the working element.

5. An apparatus as set forth in claim 1, wherein:

the catheter shaft includes a steering member, the steering member including at least one steering wire disposed in the catheter shaft having a distal end zone, wherein the distal end zone of the steering wire having at least one displacing linkage to the working element and displacement of steering wire deflects the working clement to direct the working element in a preferred direction.

6. An apparatus as set forth in claim 1, wherein the tissue-penetrating wire includes a sharpened distal end and is slidably disposed in the catheter shaft, and wherein the distal end of the tissue-penetrating wire is configured for distal advancement relative to the distal end portion of the shaft.

7. An apparatus as set forth in claim 1, wherein the distal end of the working element includes a trocar tip.

8. An apparatus as set forth in claim 1, wherein the working element includes a guide wire.

9. An apparatus as set forth in claim 8, wherein the guide wire is steerable.

10. An apparatus as set forth in claim 8, wherein the guide wire includes a transducer that emits a signal, and wherein the locator detects the signal emitted by the guide wire transducer to provide an anatomical location and orientation of the guide wire while the guide wire is manipulated.

11. An apparatus as set forth in claim 10, wherein the guide wire is steerable.

12. An apparatus as set forth in claim 1 wherein the distal end zone of the catheter shaft includes an outer surface formed with a plurality of slots partially circumscribing the catheter shaft to provide a flexible distal end zone of the catheter shaft without substantial increased axial compressibility.

13. An apparatus as set forth in claim 12, wherein the catheter shaft has a longitudinal axis and the longitudinal axis is circumscribed by a plurality of rings disposed the distal end zone of the catheter shaft, the rings defining a path for a steering wire.

14. An apparatus as set forth in claim 1 wherein the imaging device includes at least one energy transducer and the locator includes a signal generator-processor a operatively coupled to the energy transducer.

15. An apparatus as set forth in claim 14, wherein the imaging tube includes a proximal end zone an a lumen, and further comprising:

a transducer control shaft disposed in the lumen of the imaging tube, wherein the transducer control shaft includes a proximal end zone and a signal conducting path, the signal conducting path being operatively coupled to the signal generator-processor via the proximal end zone; and

wherein the locator includes a control shaft driver operatively coupled to the proximal end zone of the transducer control shaft; and

the at least one transducer is movably disposed in the lumen, manipulably attached to the transducer control shaft, and operatively coupled to the signal conducting path, and wherein the transducer control shaft driver and the signal generator-processor cooperate with the transducer control shaft and the transducer to provide a scanning image.

16. An apparatus as set forth in claim 15, wherein the transducer control shaft is rotatably disposed in the imaging tube lumen and rotationally driven by the transducer driver.

17. An apparatus as set forth in claim 14, wherein the locator includes at least one acoustic transducer, an acoustic signal generator-processor, and at least one signal conducting path for coupling the transducer to the generator-processor, wherein the working element is operated while the locator provides an acoustically-derived data output embodying the anatomical location and orientation of the working element.

18. An apparatus as set forth in claim 14, wherein the locator acquires and displays an image of the occlusion and of the working element.

19. An apparatus as set forth in claim 14 wherein the signal generator-processor correlates reflected acoustical energy with manipulations of the transducer by the driver, wherein the transducer is physically manipulated within the imaging tube while the signal generator-processor generates an output signal embodying spatially organized data about objects proximate the working element.

20. An apparatus as set forth in claim 14 wherein the transducer is rotatable and translatable by the transducer control shaft driver via the transducer control shaft, and wherein the transducer, driver, and signal generator-processor cooperate to scanningly emit and receive acoustic energy and to generate an output signal embodying the anatomical location and orientation of the working element while the working element is operated.

21. An apparatus as set forth in claim 14 wherein the transducer includes a plurality of acoustic transducers, and wherein the transducers and signal generator-processor cooperate to emit and receive acoustic energy and to generate an output signal embodying the anatomical location and orientation of the working element while the working element is operated.

22. An apparatus as set forth in claim 15, wherein a portion of the imaging tube is flexible.

23. An apparatus as set forth in claim 1, wherein the locator includes means for stabilizing the locator with respect to a surface located within a body.

24. An apparatus as set forth in claim 1, wherein the imaging tube has an exterior surface defining at least one suction coupling area to provide removable adherence to bodily tissues which stabilize positioning of the locator.

26. An apparatus as set forth in claim 24, wherein the locator includes means for selectively activating the suction coupling area.

27. An apparatus as set forth in claim 26, wherein the locator includes a pressure modulating device and at least one pressure communicating path coupling a suction coupling area to the pressure modulating device that selectively activates the suction coupling area.

28. An apparatus as set forth in claim 1 wherein the working element emits a signal and the locator detects the signal emitted by the working element, and wherein anatomical location and orientation of the working element is provided while the working element is operating.

29. An apparatus as set forth in claim 1 wherein the imaging tube includes a suction lumen, at least one imaging window, and an exterior surface defining at least one suction area including an imaging window, the suction lumen communicating with the suction area.

2. The catheter shaft includes a steering member, the steering member including at least one steering wire disposed in the catheter shaft having a distal end zone, wherein the distal end zone of the steering wire has at least one displacing linkage to the distal end zone of the catheter shaft, and the working element has at least one deflecting linkage to the catheter shaft, wherein displacement of the steering wire deflects the distal end zone of the catheter shaft thereby deflecting the working element to direct the working element in a preferred direction.

3. An apparatus as set forth in claim 2, wherein at least one tube is disposed about the steering wire, and wherein the steering wire is slidably positioned with the catheter shaft.

4. An apparatus as set forth in claim 2, wherein a ring is disposed in the distal end zone of the catheter shaft and the steering wire is affixed to the ring, and wherein the distal end of the steering wire is securely anchored in the distal end zone of the catheter shaft.

25. An apparatus as set forth in cliam 1, wherein the exterior surface of the imaging tube defines an imaging window and a plurality of suction coupling areas disposed peripherally about the window.

30. A method for treating an arterial occlusion having a distal boundary and a proximal boundary in a human or animal body, comprising the steps of:

providing an apparatus for treating an arterial occlusion, the apparatus comprising a locator including an imaging tube with a proximal end zone, a distal end zone, a lumen therebetween, and an imaging device operatively disposed in the imaging tube; and

an elongated flexible catheter shaft, disposed in the lumen of the imaging tube, including a distal end zone and a working element disposed therein;

introducing tee locator into the chest cavity, placing the distal end zone of the locator proximate the distal boundary of the occlusion,

activating the locator to discern the anatomical location and position of the working element;

advancing the catheter shaft into contact with the artery while observing the anatomical location and position of the working element via the locator;

advancing the working element through an arterial wall and into the artery; and

advancing the working element retrograde within the artery and into and through the occlusion until the working element exits the occlusion via the proximal boundary of the occlusion;

wherein the locator, catheter shaft and working element are positioned proximate the occlusion and the working element is operated to cross the occlusion, while the locator reveals the anatomical location and orientation of the working element to accomplish manipulation of the working element.

31. A method as set forth in claim 30, wherein the working element is steerable and further comprising the steps of:

steering the working element across an occlusion upon activation of the locator so that the locator, catheter shaft and working element are positioned proximate the occlusion; and

monitor the anatomical location and orientation of the working element a with the locator to accomplish steering and manipulation of the working element.

32. A method as set forth in claim 30, further comprising the steps of:

providing a second catheter adapted for manipulating the working element of the catheter shaft;

placing the second catheter proximal to the occlusion; and

positioning the working element of the catheter shaft into contact with the second catheter upon advancement of the working element retrograde within the artery and into the occlusion, and wherein the catheter shaft is manipulable via the working element thereof while positioned across the occlusion.

33. A method as set forth in claim 30, further comprising the steps of:

providing a second catheter adapted for manipulating the working element of the catheter shaft;

introducing the second catheter into the arterial lumen from an entry point proximal to the occlusion, the second catheter includes a proximal end, a distal end and a lumen therebetween; and

passing the working element through the lumen of the second catheter to the proximal end thereof upon advancement of the working element retrograde within the artery and into the occlusion, wherein the catheter shaft is manipulable via the working element thereof through the proximal end of the second catheter.

34. A method as set forth in claim 33, further comprising the steps of:

manipulating the working element via the proximal end of the second catheter upon passage of the working element to the proximal end of the second catheter; and

drawing the catheter shaft out of the locator imaging tube lumen until the proximal end of the catheter shaft exits the imaging tube lumen and is positioned proximate the distal boundary of the occlusion, wherein the catheter shaft is introduced into the artery from the locator imaging tube lumen, brought under the control by means of the second catheter, and drawn into a position across the occlusion for therapeutic and guiding functions.

35. A method as set forth in claim 30, wherein the catheter shaft consists of a guide wire and the working element consists of the distal end of the guide wire.