Catheter apparatus for treating arterial occlusions

• US 6,266,550 B1
• Filed: 01/13/2000
• Issued: 07/24/2001
• Est. Priority Date: 01/16/1998
• Status: Expired due to Term

• Current Assignee: Cardinal Health Switzerland 515 GmbH (Cardinal Health, Inc.)
• Original Assignee: LuMend, Inc. (Cardinal Health, Inc.)
• Inventors: Vetter, James W., Milo, Charles F., Hinohara, Tomoaki, Selmon, Matthew R.
• Primary Examiner(s): Lateef, Marvin M.
• Assistant Examiner(s): SHAW, SHAWNA JEANNINE
• Application Number:
  US09/483,173
• Time in Patent Office: 558 Days
• Field of Search: 600/407, 600/137, 600/146, 600/104, 600/585, 600/439, 600/462, 600/464, 600/467, 600/471, 600/478, 606/159, 606/190
• 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 2017/22077 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 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 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 a micro-invasive extraluminally operable locator for imaging the progress of the working element through the occlusion. Conical, abrasive, blunt-dissecting, and sharp-pointed, and steering and non-steering working elements including guide wires are described. Acoustic transducers and a flexible imaging tube are described for the locator. A suction cup is described for removably anchoring the imaging tube to a surface. A signal-emitting working element and cooperating signal-receiving locator are described. A method for treating arterial occlusions is described.

Claims

1. An apparatus for creating a path through an arterial occlusion, comprising:

a intra-arterial catheter shaft having distal end and a proximal end and at least one lumen therethrough;

a working element comprising;

an inner shaft slidably disposed in a lumen of the catheter shaft having a distal end zone projecting from the distal end of the catheter shaft;

a nose cone coupled to the distal end zone of the inner shaft; and

a sharp, pointed distal end proximate to a distal end of the nose cone; and

a plurality of dissecting wires wherein each dissecting wire comprises a proximal end coupled to the distal end of the catheter shaft and a distal end coupled to a proximal end of the nose cone, and a medial portion between the distal end and the proximal end, wherein each of the dissecting wires is substantially aligned with a central axis of the catheter shaft between its proximal end and its distal end, and wherein as the catheter shaft is urged through the occlusion, the nose cone contacts tissue, which slows the distal progress of the working element relative to the distal progress of the catheter shaft, causing the medial portion of each of the plurality of dissecting wires to bow outward from the central axis of the catheter shaft while maintaining the substantial alignment with the central axis of the catheter shaft such that the dissecting wires blunt dissect tissues encountered by the dissecting wires as the dissecting wires advance distally.

2. The apparatus of claim 1, further comprising an extra-arterial locator, the extra-arterial locator comprising:

a flexible imaging tube with a distal end, a proximal end, and at least one lumen therethrough;

an imaging device in the at least one lumen; and

at least one attachment device on an outer surface of the flexible imaging tube between the distal end and the proximal end, wherein the extra-arterial locator is operable to be stabilized proximate to an artery containing the occlusion using the at least one attachment device, so that the imaging device may be used to aid in directing the sharp, pointed distal end and the working element to and through the occlusion.

3. The apparatus of claim 2, further comprising:

a rotatable and translatable control shaft disposed in the lumen of the flexible imaging tube, wherein the control shaft is coupled to the imaging device at a distal end and to a motor assembly such that the imaging device may be moved in a scanning pattern to collect position data; and

a signal conducting path coupling the imaging device to an imaging instrument, wherein the imaging instrument is controllable by a computer to produce an image from the position data.

4. The apparatus of claim 3, wherein the at least one attachment device comprises a suction cup, and wherein the apparatus further comprises a lumen having a distal end coupled to the suction cup and a proximal end coupled to a pressure modulating device operable such that a vacuum may be created to stabilize a surface of the flexible imaging tube.

5. The apparatus of claim 4, wherein the suction cup is formed as a part of an exterior surface of the flexible imaging device, and wherein the exterior surface is of an elastomeric material such that the suction cup may be manipulated into different positions proximate the flexible imaging tube to assist in insertion of the flexible imaging tube into a body.

6. The apparatus of claim 5, wherein the at least one attachment device comprise two rows, each of at least one suction cup, wherein the rows are located parallel a central axis of the flexible imaging tube, and wherein the apparatus further comprises an imaging window through the flexible imaging tube that is located between the rows, the imaging device being located proximate to the imaging window.

7. A method for treating an arterial occlusion in a mammal, comprising:

inserting a catheter shaft and a working element into an occluded artery, wherein the working element comprises,

an inner shaft slidably disposed in a lumen of the catheter shaft having a distal end zone projecting from the distal end of the catheter shaft;

a nose cone coupled to the distal end zone of the inner shaft; and

a sharp, pointed distal end proximate to a distal end of the nose cone, wherein a distal end of the catheter shaft and a proximal end of the nose cone are coupled by a plurality of flexible dissecting wires, each of the flexible wires having a medial portion between the distal end of the catheter shaft and the proximal end of the nose cone, and wherein each of the dissecting wires is substantially aligned with a central axis of the catheter shaft between the distal end of the catheter shaft and the proximal end of the nose cone;

urging the pointed, sharp end against the occlusion such that an opening in the occlusion is created and such that a distal end of the nose cone enters the opening;

further urging the nose cone against the occlusion, wherein as the nose cone encounters resistance, which slows the distal progress of the working element relative to the distal progress of the catheter shaft, the medial portion of each of the plurality of dissecting wires is caused to bow outward from the central axis of the catheter shaft such that the dissecting wires blunt dissect tissues encountered by the dissecting wires and widen the opening as the dissecting wires advance distally.

8. The method of claim 7, further comprising:

positioning an extra-arterial locator proximate an occluded artery, wherein the locator comprises a flexible imaging tube and an imaging device disposed in a lumen of the flexible imaging tube;

stabilizing the extra-arterial locator by activating an attachment device that causes the extra-arterial locator to be temporarily fixed to a body part of the mammal;

positioning the working element against the occlusion by,

manipulating the catheter shaft by applying unequal pressure to at least two steering wires attached to a proximal end of the working element; and

manipulating an imaging device control shaft of the extra-arterial locator to rotate and translate the imaging device in a scanning pattern such that an image of an area of the occlusion may be generated.

9. The method of claim 8, wherein stabilizing the extra-arterial locator comprises operating a pressure control device coupled to suction cups on an exterior surface of the flexible imaging tube such that the suction cups adhere to the body part.

10. The method of claim 9, wherein positioning the extra-arterial locator comprises deforming the suction cups about the exterior surface of the flexible imaging tube such that positioning around body parts is facilitated.