Hydro-rotary vascular catheter

• US 4,950,238 A
• Filed: 07/20/1989
• Issued: 08/21/1990
• Est. Priority Date: 07/07/1988
• Status: Expired due to Fees

• Current Assignee: Clarence E. Sikes
• Original Assignee: Clarence E. Sikes
• Inventors: Sullivan, Dennis E.
• Primary Examiner(s): Thaler, Michael H.
• Assistant Examiner(s): Lewis, William
• Application Number:
  US07/383,362
• Time in Patent Office: 397 Days
• Field of Search: 604/22, 606/159, 606/167, 606/170, 606/194, 606/127, 606/128, 606/180, 134/167 C, 134/168 C, 239/214.15
• US Class Current: 604/22
• CPC Class Codes: A61B 17/3203 Fluid jet cutting instruments
• CPC Class Codes: A61B 17/32037 for removing obstructions from inner organs or blood vessels, e.g. for atherectomy
• 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 2017/22079 with suction of debris
• CPC Class Codes: A61M 2025/0073 Tip designed for influencing the flow or the flow velocity of the fluid, e.g. inserts for twisted or vortex flow
• CPC Class Codes: A61M 25/0082 Catheter tip comprising a tool

Abstract

A hydro-rotary vascular catheter for insertion in a body vessel comprises a tubular outer shell having a fluid-directing head rotatably mounted at its distal end. A plurality of outlet passages are formed about the circumference of the fluid-directing head, including a row of primary outlet passages formed near the base of the fluid-directing head and a row of secondary outlet passages formed forwardly of the primary outlet passages. The primary outlet passages are inclined radially and tangentially with respect to the shell to impart a tangential component of velocity to fluid exiting through the primary openings, while the secondary outlet openings are inclined axially in order to eject fluid in a primarily forward direction. A protective shield surrounds the primary openings to prevent the radially ejected fluid from rupturing the walls of the vessel, and to increase the turbulence of the exiting fluid.

Claims

1. A catheter apparatus for removing undesired material from a constricted area in a vessel of a patient containing a body fluid, said apparatus comprising:

(a) a tubular shell for insertion within the vessel in the patient'"'"'s body, said shell having a proximal end, a distal end, and a longitudinal axis;

(b) a non-abrasive rotary fluid-directing head secured to the distal end of said outer shell and mounted for rotation about the longitudinal axis of said shell;

(c) isolation means for isolating said constricted area from the rest of said vessel, said isolation means including (i) first isolation means mounted on said shell for placement upstream of said constricted area, and (ii) second isolation means mounted in the distal end of said shell for placement downstream of said constricted area;

(d) first supply means in said tubular shell for introducing a flushing fluid into said constricted area at a relatively high pressure;

(e) second supply means in said tubular shell for carrying the body fluid beyond said second isolation means to allow circulation of the body fluid downstream of said constricted area;

(f) spin means for imparting a spin to said rotary fluid-directing head, said spin means including primary outlet passages formed through said rotary fluid-directing head for directing streams of pressurized flushing fluid exiting said outlet passages to produce a torque causing said head to spin around the longitudinal axis of said shell;

(g) return means in said shell for carrying flushing fluid and debris created by action of said catheter apparatus away from the constricted area in said vessel out of the patient'"'"'s body; and

(h) shield means for preventing fluid exiting said primary outlet passages from directly impacting said vessel.

2. The catheter apparatus of claim 1, in which said isolation means comprises two balloon means, including a first balloon means for placement downstream of the constricted area and a second balloon means for placement upstream of the constricted area, each of said balloon means being expandable by a pressure medium so as to contact the inside walls of said vessel to operatively seal off and isolate the constricted area.

3. The catheter apparatus of claim 1, in which said rotary fluid-directing head further comprises secondary openings formed forwardly of said primary openings, each of said secondary openings communicating at one end with said first supply means and being oriented to eject fluid in primarily forward direction.

4. A catheter apparatus for removing undesired material from a constricted area in a vessel containing a body fluid, said apparatus comprising:

(a) a tubular outer shell for insertion in a vessel within a patient'"'"'s body, said shell having a proximal end and a distal end;

(b) a nonabrasive rotary fluid-directing head mounted on the distal end of said outer shell for rotation about a spin axis;

(c) two balloon means, including a first balloon means for placement downstream of the constricted area and a second balloon means for placement upstream of the constricted area, each of said balloon means being expandable by a pressurized medium to contact the inside walls of said vessel to operatively seal off and isolate the constricted area;

(d) a flushing fluid supply conduit disposed within said outer shell for delivering a pressurized flushing fluid to the constricted area;

(e) a body fluid supply duct disposed within said outer shell for delivering said patients body fluid under pressure to a location downstream of the constricted area and beyond said first balloon means;

(f) spin means for imparting a spin to said rotary fluid-directing head, said spin means including primary outlet passages formed through said rotary fluid-directing head, each of said outlet passages communicating with said flushing fluid supply conduit and being oriented to cause flushing fluid exiting said primary outlet passages to produce a torque causing said head to spin around its spin axis;

(g) a return conduit for carrying flushing fluid and debris from said undesired material from the constricted area created by the action of the flushing fluid exiting said rotary fluid-directing head away from said constricted area and out of the patient'"'"'s body; and

(h) shield means mounted on the tubular shell for preventing fluid exiting said primary outlet passages from directly impacting said vessel.

5. The catheter apparatus of claim 4, in which said body fluid supply duct comprises a hollow needle disposed for axial movement within said tubular outer shell, said first balloon means being carried in the distal end of said needle and being in fluid communication with the interior of said needle so as to be inflated by the pressurized body fluid carried within said needle.

6. The catheter apparatus of claim 5, in which said first balloon means defines an aperture for allowing the patient'"'"'s body fluid to exit the catheter and reenter the vessel downstream of the constricted area.

7. The catheter apparatus of claim 4, in which said second balloon means is carried peripherally about said tubular outer shell of said catheter, said second balloon being in fluid communication with a radially extending passageway leading from said supply channel for allowing the pressurized flushing fluid in said supply channel to enter and inflate said second balloon.

8. The catheter apparatus of claim 4, in which said rotary fluid-directing head further comprises secondary openings formed forwardly of said primary openings, each of said secondary openings communicating at one end with said first supply means and being oriented to eject fluid in a primarily forward direction.

9. A vascular catheter apparatus for removing undesired material from a constricted area in a blood vessel of a patient, said apparatus comprising:

(a) a tubular outer shell for insertion within the blood vessel, said shell having a proximal end and a distal end;

(b) an annular inner wall dividing the interior of said tubular outer shell into two coaxial conduits, the inner conduit defining a supply channel for transporting a pressurized flushing fluid to the distal end of the outer shell and the outer conduit comprising a return channel communicating with at least one opening in said tubular outer shell for allowing fluids and undesired material in the blood vessel to enter said return channel for removal from the patient;

(c) a nonabrasive rotary fluid-directing head mounted on the distal end of said outer shell for rotation about an axis of rotation, said head being in communication with the supply channel of the shell, a central opening formed at the distal end of said rotary fluid-directing head, and a plurality of primary outlet passages formed through a circumference of said rotary fluid-directing head, each of said primary outlet passages being oriented with respect to the axis of rotation of said head so that pressurized flushing fluid from the supply channel exiting said primary outlet passages produces a torque acting to rotate said head about its axis of rotation;

(d) a hollow needle defining a blood supply duct for conducting the patients'"'"'s blood under pressure through the constricted area, said hollow needle being disposed for axial movement in said supply channel from a retracted position totally within said outer shell to an extended position in which the distal end of said needle protrudes through said central opening in the distal end of said rotary fluid-directing head and beyond the constricted area of the vessel;

(e) a first inflatable balloon carried in the distal end of said hollow needle, said first inflatable balloon being in fluid communication with the interior of said hollow needle and being expandable by the pressurized blood to contact the inside walls of said vessel to operatively seal of and isolate the downstream end of said constricted area, said first balloon having an aperture for allowing blood to enter the patients blood vessel downstream of the constricted area;

(f) a second inflatable balloon carried peripherally about said tubular outer shell of said catheter at a location upstream of said first inflatable balloon, said second balloon being in fluid communication with a radially extending passageway leading from the supply channel to allow pressurized flushing fluid from said supply channel to enter and to inflate the second balloon causing the second balloon to contact the inside walls of the blood vessel to operatively seal off and to isolate the upstream end of the constricted area; and

(g) protective shield means mounted on the distal end of the shield surrounding and spaced from that portion of said head through which the primary outlet passages passages are formed for preventing pressurized flushing fluid exiting said primary outlet passages from directly impacting said vessel;

whereby, after blood has been supplied under pressure to said blood supply duct in said hollow needle and a pressurized flushing fluid has been supplied to the supply channel, causing the first and second balloons to inflate and seal off the constricted area, the pressurized flushing fluid exiting through the primary outlet passages of said head cause said head to rotate about its spin axis, the rotation of the head and the turbulent flow of the flushing fluid in the isolated restricted area removing undesired material from the restricted area of the vessel which flushing fluid and removed undesired material enters the catheter through said opening in the tubular outer shell for removal from the patient'"'"'s body.

10. The vascular catheter apparatus of claim 9, in which said pressurized flushing fluid comprises a saline solution.

11. The vascular catheter apparatus of claim 9, in which said pressurized flushing fluid comprises a solution of digestive enzymes.

12. The catheter apparatus of claim 9, in which said head further comprises at least one row of secondary openings formed forwardly of said primary openings, each of said secondary openings communicating at one end with said first supply means and being oriented to eject fluid in a primarily forward direction.