Catheter system having a small diameter rotatable drive member

• US 4,923,462 A
• Filed: 08/15/1988
• Issued: 05/08/1990
• Est. Priority Date: 03/17/1987
• Status: Expired due to Fees

• Current Assignee: Dow Corning Enterprises Incorporated
• Original Assignee: Cordis Corporation (Cardinal Health, Inc.)
• Inventors: Stevens, Robert C.
• Primary Examiner(s): NOT, DEFINED
• Assistant Examiner(s): NOT, DEFINED
• Application Number:
  US07/233,998
• Time in Patent Office: 631 Days
• Field of Search: 604/22, 604/27, 604/53, 128/304, 128/305, 128/310, 606/159, 606/180
• US Class Current: 606/159
• 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 2017/22075 with motorized advancing or retracting means
• CPC Class Codes: A61B 2017/22094 for crossing total occlusions, i.e. piercing
• CPC Class Codes: A61B 2090/3933 Liquid markers

Abstract

Method and apparatus for opening a partially or totally occluded blood vessel. A conventional catheter is inserted within a patient and the condition of a blood vessel ascertained. If it is determined that sufficient blockage exists to cannulize the vessel, a small diameter drive catheter having a rotatable head at a distal end is inserted into the conventional catheter in close proximity to the occluded region. The head is rotated at high speeds as dye is injected through the catheter to monitor progress of the procedure. Different sized rotating heads having different blockage removing characteristics are inserted until the procedure has been completed to the physician'"'"'s satisfaction. The drive mechanism is a small d.c. powered hand-held motor operated by the physician during the procedure.

Claims

1. A process for opening a partially or totally blocked blood vessel within a subject comprising the steps of:

inserting an elongated angiographic catheter into a subject blood vessel;

injecting an opaque dye into a proximal end of the angiographic catheter to cause said opaque dye to flow through a central passageway of said angiographic catheter and enter the blood vessel;

imaging the patient to locate obstructions or regions of reduced blood flow within the blood vessel which can be detected due to the presence of the opaque dye within the blood vessel;

providing a drive catheter by rotatably supporting an elongated flexible drive wire having an enlarged distal head at one end within a tightly coiled wire having adjacent coils that touch and extend along a substantial length of said drive wire to form a sheath that acts as a bearing for the drive wire;

without withdrawing the angiographic catheter from the patient blood vessel inserting the distal head of the drive catheter into a proximal end of the central passageway of said angiographic catheter and pushing the drive catheter into the center passageway of the angiographic catheter until said enlarged distal head is in proximity to an obstruction or region of reduced blood flow within the blood vessel; and

rotating said drive wire at high speed relative said coiled wire sheath bearing by rotating a proximal end of the drive wire not covered by the sheath to effect high speed rotation of the enlarged distal head for opening said blood vessel.

2. The process of claim 1 wherein in addition to rotating the distal head at high speed, suction is applied at a proximal end of the elongated catheter to remove material separated from the blood vessel either during or after high speed rotation of the rotatable head.

3. The process of claim 1 wherein the opaque dye and saline is injected during high speed rotation of the head and the patient is imaged during said high speed rotation to observe the blocked region of the blood vessel.

4. The process of claim 1 wherein multiple elongated rotatable drives are inserted having differing dimensions during the process.

5. The process of claim 1 wherein as the distal head is rotated at high speed it is brought into physical contact with the obstructions or regions of reduced blood flow and the angiographic catheter is inserted along the vessel to guide the distal drive as the rotatable head opens said obstructions.

6. A catheter system for opening an obstruction in a blood vessel comprising:

(a) a drive catheter including a distal tip for engaging the obstruction, a drive shaft coupled to the tip and an elongated sleeve supporting the drive shaft for rotation relative the elongated sleeve and having an outer surface coated with a synthetic material to facilitate insertion of the drive catheter into a diagnostic catheter, and

(b) connector apparatus for directing the drive catheter and a fluid dye through the diagnostic catheter to the region of the obstruction including;

(i) branch connector means having a connector body including first and second input openings in communication with an output opening, said branch connector means for routing a fluid dye from one input opening through the output opening and routing the drive catheter from the second input opening through the output opening;

(ii) coupling means for coupling the branch connector means to the diagnostic catheter with the output opening of said connector body opening into said diagnostic catheter for routing said drive catheter and fluid into the diagnostic catheter; and

(iii) seal means coupled to the branch connector means for inhibiting the fluid dye entering the first input opening from exiting the second input opening along an outside surface of the elongated sleeve of the drive catheter, the seal means comprising a heat shrinkable plastic tube that sealingly engages the drive catheter sleeve at the second input opening to the connector body while allowing sliding movement to the drive catheter through said connector body to allow positioning of the distal tip relative to the branch connector means.

7. A process for dislodging obstructing matter from within a subject organ comprising the steps of:

inserting an elongated diagnostic catheter having a central passageway into a subject organ;

injecting an opaque dye through the central passageway of said diagnostic catheter into the organ while imaging the patient to isolate said matter within the organ;

rotatably supporting a solid, elongated flexible drive shaft, having an enlarged distal head at one end within a helically wound coiled wire sheath bearing having adjacent coils that touch and which extend along a substantial length of said flexible drive shaft;

without withdrawing the diagnostic catheter from the organ inserting the enlarged distal head into a proximal end of the central passageway of said diagnostic catheter and pushing the drive shaft and sheath through the diagnostic catheter until said enlarged distal head is in proximity to the matter within the organ; and

rotating said drive shaft at high speed relative the coiled wire sheath bearing by rotating a proximal end of the drive shaft not covered by the sheath to effect high speed rotation of the enlarged head to dislodge the matter from said organ.

8. The process of claim 7 wherein in addition to rotating the head at high speed, suction is applied at a proximal end of the diagnostic catheter to remove dislodged matter from the organ either during or after high speed rotation of the rotatable head.

9. The process of claim 7 wherein the opaque dye and saline is injected during high speed rotation of the head and the patient is imaged during said high speed rotation to observe the region of the organ that includes the matter.

10. The process of claim 7 wherein multiple elongated rotatable drives are inserted having differing dimensions during the process.

11. The process of claim 7 wherein as the rotatable head is rotated at high speed it is brought into physical contact with the matter and the elongated catheter is inserted further into the organ to guide the rotatable drive as the rotatable head removes said matter.

12. A catheter system for dislodging material from within an organ comprising:

(a) a drive catheter including a distal tip for engaging the material, a drive shaft coupled to the tip, and an elongated sleeve supporting the drive shaft for rotation relative the elongated sleeve and having an outer surface coated with a synthetic material to facilitate insertion of the drive catheter into a diagnostic catheter, and

(b) connector apparatus for directing the drive catheter and a fluid dye through the diagnostic catheter to the region of the material including;

(i) branch connector means having a connector body including first and second input openings in communication with an output opening for routing a fluid dye from one input opening through the output opening and routing the drive catheter from the second input opening through the output opening;

(ii) coupling means for coupling the branch connector means to the diagnostic catheter with the output opening of said connector body opening into the diagnostic catheter for routing said drive catheter and fluid into the diagnostic catheter; and

(iii) seal means coupled to the branch connector means for inhibiting the fluid dye entering the first input opening from exiting the second input opening along an outside surface of the elongated sleeve of the drive catheter, the seal means comprising a heat shrinkable plastic tube that sealingly engages the drive catheter sleeve at the second input opening to the connector body while allowing sliding movement to the drive catheter through said connector body to allow positioning of the distal tip relative to the branch connector means.

13. The catheter system of claim 12 wherein the elongated sleeve comprises a tightly coiled wire coated on an outer surface with a synthetic covering.