Drug delivery system

• US 6,494,861 B1
• Filed: 01/15/1997
• Issued: 12/17/2002
• Est. Priority Date: 01/15/1997
• Status: Expired due to Fees

• Current Assignee: Boston Scientific Corporation
• Original Assignee: Boston Scientific Corporation
• Inventors: Tsukernik, Vladimir
• Primary Examiner(s): Buiz, Michael
• Assistant Examiner(s): MENDEZ, MANUEL A
• Application Number:
  US08/783,268
• Time in Patent Office: 2,162 Days
• Field of Search: 604/96, 604/97, 604/98, 604/99, 604/100, 604/102, 604/30, 604/31, 604/53, 604/65-67, 604/104, 604/118, 606/191, 606/192, 606/193, 606/194, 128/DIG.12, 128/DIG.13
• US Class Current: 604/67
• CPC Class Codes: A61M 2025/105 having a balloon suitable for drug delivery, e.g. by using holes for delivery, drug coating or membranes
• CPC Class Codes: A61M 25/10 Balloon catheters A61M25/0125 takes precedence; embolectomy A61B17/22032; retractors A61B17/02; inflatable balloons for placing stents or stent-grafts A61F2/958 ; stomach balloons for treatment of obesity A61F5/0003; oesophagal tubes A61J15/00
• CPC Class Codes: A61M 25/10182 Injector syringes
• CPC Class Codes: A61M 25/10184 Means for controlling or monitoring inflation or deflation
• CPC Class Codes: A61M 25/104 used for angioplasty

Abstract

A system for controlling delivery of a physiological fluid internally to a patient from a balloon catheter. The system includes a controller, an inflation-fluid pressurizer for maintaining inflation fluid in an inflation-fluid conduit under pressure, and a physiological-fluid pressurizer for maintaining physiological fluid in a physiological-fluid conduit under pressure. The inflation-fluid pressurizer is connected to receive signals from the controller to cycle pressure in the inflation-fluid conduit between a balloon inflating pressure and a balloon deflating pressure. The physiological-fluid pressurizer is connected to receive signals from the controller to cycle pressure in the physiological-fluid conduit between a fluid delivery pressure and a resting pressure. The controller is programmed to synchronize signals to the inflation-fluid pressurizer with signals to the physiological-fluid pressurizer. Thus, periods of balloon inflating pressure in the inflation-fluid conduit generally overlap with periods of fluid delivery pressure in the physiological-fluid conduit, and periods of balloon deflating pressure in the inflation-fluid conduit generally overlap with periods of resting pressure in the physiological-fluid conduit.

Claims

1. A system for controlling delivery of a physiological fluid internally to a patient from a balloon catheter, the balloon catheter comprising a distal balloon connected to a catheter shaft, an inflation-fluid conduit connecting the balloon to a proximal source of pressurized balloon inflation fluid, and a physiological-fluid conduit connecting a fluid-delivery outlet of the balloon catheter to a proximal source of pressurized physiological fluid;

the system comprising

(a) a controller;

(b) an inflation-fluid pressurizer for maintaining inflation fluid in the inflation-fluid conduit under pressure, the inflation-fluid pressurizer being connected to receive signals from the controller to cycle pressure in the inflation-fluid conduit between a balloon inflating pressure and a balloon deflating pressure;

(c) a physiological-fluid pressurizer for maintaining physiological fluid in the physiological-fluid conduit under pressure, the physiological-fluid pressurizer being connected to receive signals from the controller to cycle pressure in the physiological-fluid conduit between a fluid delivery pressure and a resting pressure;

the controller being programmed to synchronize the signals to the inflation-fluid pressurizer with the signals to the physiological-fluid pressurizer, such that periods of balloon inflating pressure in the inflation-fluid conduit generally overlap with periods of fluid delivery pressure in the physiological-fluid conduit, and periods of balloon deflating pressure in the inflation-fluid conduit generally overlap with periods of resting pressure in the physiological-fluid conduit.

2. The system of claim 1 further comprising a holder sized and shaped to hold both:

(i) an inflation fluid delivery chamber having a first moveable wall, movement of the first moveable wall changing the volume of the inflation fluid delivery chamber, and (ii) a physiological fluid delivery chamber having a second moveable wall, movement of the second moveable wall changing the volume of the physiological fluid delivery chamber.

3. The system of claim 1 in which the inflation-fluid pressurizer comprises a first driver and a first connector sized and shaped for connection of the first driver to a first movable wall of an inflation fluid delivery chamber, movement of the first moveable wall changing the volume of the inflation fluid delivery chamber, and the physiological-fluid pressurizer comprises a second driver and a second connector sized and shaped for connecting of the second driver to a second movable wall of a physiological fluid delivery chamber, movement of the second moveable wall changing the volume of the physiological fluid delivery chamber, the first driver being connected to the controller via a first circuit, and the second driver being connected to the controller via a second circuit.

4. The system of claim 3 in which the first connector is a push-pull coupling, whereby the first driver can push the first moveable wall to decrease the volume of the inflation fluid delivery chamber and the first driver can pull the first moveable wall to increase the volume of the inflation fluid delivery chamber.

5. The system of claim 3 in which the second connector is a push-only coupling, whereby the second driver can push the second moveable wall to decrease the volume of the physiological fluid delivery chamber, and the second driver cannot pull the second moveable wall to increase the volume of the physiological fluid delivery chamber.

6. The system of claim 4 in which the holder accommodates a first syringe, the first syringe comprising a plunger which moves the first movable wall, and the push-pull coupling comprises a flattened region of the plunger at least partially enveloped by a mating structure of the first driver, whereby movement of the first driver toward the inflation fluid delivery chamber pushes the plunger and moves the first moveable wall to decrease the volume of the inflation fluid delivery chamber, thereby increasing the pressure in the inflation-fluid conduit, and movement of the first driver away from the inflation fluid delivery chamber engages the plunger and moves the first moveable wall to increase the volume of the inflation fluid delivery chamber.

7. The system of claim 5 or claim 6 in which the holder accommodates a second syringe, the second syringe comprising a plunger which moves the second movable wall, and the push-only coupling comprises a flattened region of the plunger which mates with a flattened member of the second driver, whereby movement of the first driver toward the physiological fluid delivery chamber pushes the plunger and moves the second moveable wall to decrease the volume of the physiological fluid delivery chamber, thereby increasing the pressure in the physiological fluid delivery chamber, and movement of the second driver away from the physiological fluid delivery chamber disengages the flattened region of the plunger from the flattened structure of the second driver without changing the volume of the physiological fluid delivery chamber.

8. The system of claim 3 in which the first driver comprises a first pneumatic cylinder which is independently controlled by a first solenoid relay, said first solenoid relay being controlled by the controller.

9. The system of claim 3 or claim 8 in which the second driver comprises a second pneumatic cylinder which is independently controlled by a second solenoid relay, said second solenoid relay being controlled by the controller.

10. The system of claim 1, wherein the physiological fluid is a drug.

11. The system of claim 1, wherein the programmable controller comprises a timer.

12. The system of claim 2 in which the system further comprises a housing that surrounds the holder.

13. A method for delivering a physiological fluid internally to a patient from a balloon catheter, the balloon catheter comprising a distal balloon connected to a catheter shaft, an inflation-fluid conduit connecting the balloon to a proximal source of pressurized balloon inflation fluid, and a physiological-fluid conduit connecting a fluid-delivery outlet of a balloon catheter to a proximal source of pressurized physiological fluid;

the method comprising;

providing a system comprising (a) a controller;

(b) an inflation-fluid pressurizer for maintaining inflation fluid in the inflation-fluid conduit under pressure; and

(c) a physiological-fluid pressurizer for maintaining physiological fluid in the physiological-fluid conduit under pressure;

alternately inflating and deflating the balloon at the internal location by cycling pressure in the inflation-fluid conduit between a balloon inflating pressure and a balloon deflating pressure;

alternately delivering physiological fluid at the internal location by cycling pressure in the physiological-fluid conduit between a fluid delivery pressure and a resting pressure;

synchronizing cycling of the pressure in the inflation-fluid conduit with cycling of the pressure in the physiological-fluid conduit, so that periods of balloon inflating pressure in the inflation-fluid conduit generally overlap with periods of fluid delivery pressure in the physiological-fluid conduit, and periods of balloon deflating pressure in the inflation-fluid conduit generally overlap with periods of resting pressure in the physiological-fluid conduit.