Classifications

• • A—HUMAN NECESSITIES
  • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
  • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
  • A61M25/00—Catheters; Hollow probes
  • A61M25/10—Balloon catheters
  • A61M25/104—Balloon catheters used for angioplasty
• • A—HUMAN NECESSITIES
  • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
  • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
  • A61M25/00—Catheters; Hollow probes
  • A61M25/10—Balloon catheters
  • A61M2025/1043—Balloon catheters with special features or adapted for special applications
  • A61M2025/1052—Balloon catheters with special features or adapted for special applications for temporarily occluding a vessel for isolating a sector
• • A—HUMAN NECESSITIES
  • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
  • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
  • A61M25/00—Catheters; Hollow probes
  • A61M25/10—Balloon catheters
  • A61M2025/1043—Balloon catheters with special features or adapted for special applications
  • A61M2025/1097—Balloon catheters with special features or adapted for special applications with perfusion means for enabling blood circulation only while the balloon is in an inflated state, e.g. temporary by-pass within balloon
• • A—HUMAN NECESSITIES
  • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
  • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
  • A61M25/00—Catheters; Hollow probes
  • A61M25/10—Balloon catheters
  • A61M25/1011—Multiple balloon catheters

Definitions

• the field of the invention relates to perfusion cathe ⁇ ters, specifically those adapted to perform angioplasty pro ⁇ cedures.
• Performing coronary angioplasty requires inflation of a balloon in an arterial passage in an effort to clear a flow- path for blood by expanding the stenosis.
• the balloon When the balloon is deflated, the result is an increase in the available cross- sectional area for blood flow in the arterial passage.
• the problem with the angioplasty procedure is that during balloon inflation, the circulation is cut off. This can result in ischemia and electrocadiologic changes.
• Other observed phe ⁇ nomena occurring during or shortly after coronary angioplasty are abrupt reclosure where the stenosis after the conclusion of coronary angioplasty realigns itself so as to reclose the arterial passage.
• portions of the stenosis can break loose at one end and obstruct the flowpath. This is known as intimal flaps. Obviously, all of these conditions result in emergencies, with potential for severe consequences if not immediately addressed.
• the angioplasty catheter needs to have sufficient column strength so as to have good pushability and torquability reactions to allow advancement of the catheter to the stenosis.
• the pa ⁇ tient's blood pressure proximally of the stenosis drives the blood through the openings and out the distal end of the catheter.
• One serious disadvantage of the use of such cathe- ters for perfusion is that at the time the patient requires angioplasty, the patient has fairly low blood pressure or is in AV block, and the patient's ventricular ejection fraction is low.
• These elements comprise the driving force to push the blood through the openings illustrated in U.S. Patents 4,790,315 and 4,661,094.
• Another shortcoming of the catheter illustrated in the '315 patent is that it has a relatively high profile, to the extent that it cannot be used as a pri ⁇ mary catheter.
• a low-profile angioplasty catheter which is insertable through a guiding catheter.
• the angioplasty cath ⁇ eter has two balloons.
• the distal balloon dilates the steno- sis.
• the proximal balloon is separately inflatable and se ⁇ lectively closes the annular passage between the angioplasty catheter and the guiding catheter.
• the angioplasty catheter has a central lumen with a series of openings allowing fluid communication from the central lumen into the annular passage proximally of the balloon which seals the annular passage.
• blood can be withdrawn from an arterial source through a lumen (or plurality thereof) in the guiding catheter and pumped into the annular passage between the angioplasty catheter and the guiding catheter.
• the blood then passes through the openings proximal to the proximal balloon into the central lumen of the PTCA catheter and flows beyond the distal tip of the angio ⁇ plasty catheter to maintain circulation of the patient's blood at a point distal of the stenosis.
• Figure 1 is a sectional view of the catheter assembly of the present invention, illustrating the balloons in an in ⁇ flated position.
• Figure 2 is a sectional view adjacent the proximal end of the guiding catheter assembly of the present invention.
• Figure 3 is a sectional view of the angioplasty catheter proximally of both balloons illustrated in Figure 1.
• a guiding catheter 13 has an outer sheath 8 integral to the guiding catheter connected adjacent its proximal end.
• the guiding catheter 13 terminates in a hub 6.
• sheath 8 has a plurality of lumens 20, 21 and 22.
• Lumen 20 can be used to monitor pressure in the patient's artery (not shown).
• Lumen 20 terminates in an open end 11 where the patient's blood pressure can be sensed in view of fluid com ⁇ munication from end 11 through lumen 20 to connection 7.
• a suitable pressure transducer can be connected to connection 7 to provide continuous monitoring of the patient's blood pres ⁇ sure during inflation of balloon 17. Additional lumens 21 and 22 are provided for the purposes of blood aspiration.
• connection 29 is the suction connection for pump 28.
• the discharge of pump 28 is attached to connection 9, which is a side port to the hemostasis connection 5.
• guiding catheter hub 6 and hemostasis connector 5 can be made integral.
• the PTCA catheter 14 extends through guiding catheter 13, forming an annular passage 30 between PTCA catheter 14 and guiding catheter 13.
• a plurality of openings 15 provide fluid communication between lumen 26 (see Figure 3) and annular passage 30.
• Pump 28 discharges into connection 9, which is in fluid communication with annu- lar passage 30, which in turn is in fluid communication with lumen 26 through openings 15.
• a proximal balloon 16 can be selectively inflated to seal off annular passage 30.
• Proximal balloon 16 is inflated via proximal balloon inflation lumen 24, which extends from proximal balloon 16 to the proximal end of the catheter at connection 3.
• Suitable media can be in ⁇ jected into connection 3 to selectively inflate or deflate balloon 16.
• the distal balloon 17 is in fluid communication with distal balloon inflation lumen 25, which extends substantially the length of the catheter to connection 4.
• the distal balloon 17 can be selectively inflated or de ⁇ flated by injecting or withdrawing appropriate media into or from connection 4.
• the proximal end of the PTCA catheter 14 has a guidewire port 2, having a centerline substantially coincident with the longitudinal axis of the PTCA catheter 14 to allow a guidewire 1 to pass completely through lumen 26 and out the PTCA distal opening 18, wherein the tip 19 of guide ⁇ wire 1 is shown to extend.
• a tube 27 can be option ⁇ ally installed within lumen 26.
• the guidewire can pass through the inside of tube 27.
• tube 7 extends the length of PTCA catheter 14 to a point proximally of open ⁇ ings 15.
• a stiffness rod can be em- ployed and preferably located in lumens 24 or 25.
• proximal balloon 16 typically, the center of proximal balloon 16 is about 15-
• the overall length of the PTCA catheter 14 is in the order of 130-140 cm.
• the guiding catheter 13 is advanced from the femoral artery up to the aortic root over a standard 0.032-
• the arterial passage proximal to the inflated balloon 17 is in fluid communication with ends 12 of lumens 21 and 22.
• Pump 28 is activated to pump the patient's blood from the artery proximally to the inflated balloon 17, back into connection 9, through the annular passage 30, through openings 15, back into the lumen catheter 14, distally of balloon 17. It should be noted that prior to pumping of the blood, saline is pumped into the prox ⁇ imal end of the catheter through lumen 26 and is retained within lumen 26 during the blood pumping to prevent the blood passing through openings 15 from traveling toward the proximal end of the catheter.
• openings 15 When the blood is pumped through openings 15, it cannot move in the proximal direction but moves distally out the distal end of the catheter 14 at point 18.
• One immediately apparent advantage to this scheme is that the patient's blood pressure can be continuously monitored because it is continuously sensed through opening 11, which is in fluid communication with connection 7, to which a pressure transducer (not shown) is connected.
• the available cross-sectional area for substantially the entire length of the catheter 14 is dramatically increased by pumping the blood on the outside of catheter 14, rather than through central lumen 26.
• Typical guiding catheters have inside diameters of 0.080 inch, while the PTCA catheter described herein has outside diameters of 0.045 inch.
• the resulting cross-sectional area of annular passage 30 is approximately 0.01375 sq.in. which is consider ⁇ ably larger than the best possible area available in the typi- cal PTCA catheter for distal hemoperfusion, which is approxi ⁇ mately 0.032 inches in diameter, with a resulting area of approximately 0.0008 sq.in.
• the flow cross-sectional area for substantially the entire length of a PTCA catheter 14 which is normally about 130-140 cm. is about 17 times greater than trying to perfuse the blood through the lumen 26 of the PTCA catheter 14 over its entire length.
• Another advantage of the apparatus A of the present invention is that the guiding catheter 13 is built with sheath 8 to allow the pressure measurement through open ⁇ ing 11 and the blood aspirated through opening 12 without having to install additional catheters in the patient to provide for these needs. This results in decrease in trauma to the patient due to the compact design of the apparatus of the present invention.
• stiffener tube 27 also encompasses a stiffening rod.
• a blood pump such as illus ⁇ trated in co-pending application Serial No. 07/347,406, also invented by these Applicants, can be employed as pump 28 illustrated in Figure 1.
• This is a piston-type pump with a pulsation dampener and is designed not to have any dead spots therein.
• the pressures that this pump can develop i.e., in the order of 200 psi, will not necessarily be re ⁇ quired in view of the dramatic increase in the flowing cross- sectional area of the apparatus A of the present invention. Since the flowing cross-sectional area proximally to openings 15 has been increased in the order of approximately 17-20 times, the available cross-sectional area of prior low-profile designs, pump pressures in the order of 50-100 psi will be sufficient to deliver approximately 60 cc/min. distally of balloon 17 through opening 18.

Landscapes

• Health & Medical Sciences (AREA)
• Heart & Thoracic Surgery (AREA)
• Life Sciences & Earth Sciences (AREA)
• Anesthesiology (AREA)
• Child & Adolescent Psychology (AREA)
• Biophysics (AREA)
• Pulmonology (AREA)
• Engineering & Computer Science (AREA)
• Vascular Medicine (AREA)
• Biomedical Technology (AREA)
• Hematology (AREA)
• Animal Behavior & Ethology (AREA)
• General Health & Medical Sciences (AREA)
• Public Health (AREA)
• Veterinary Medicine (AREA)
• Media Introduction/Drainage Providing Device (AREA)

Applications Claiming Priority (1)

Publications (2)

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• 1991
  • 1991-05-23 EP EP19910910972 patent/EP0586371A4/en not_active Withdrawn
  • 1991-05-23 WO PCT/US1991/003638 patent/WO1992020398A1/en not_active Application Discontinuation
  • 1991-05-23 JP JP51098591A patent/JP3190332B2/ja not_active Expired - Fee Related

Non-Patent Citations (1)

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