HAND-HELD FLUID DELIVERY DEVICE WITH SENSORS TO DETERMINE FLUID PRESSURE AND VOLUME OF FLUID DELIVERED TO INTERVERTEBRAL DISCS DURING DISCOGRAPHY

• US 20070112299A1
• Filed: 05/26/2006
• Published: 05/17/2007
• Est. Priority Date: 05/27/2005
• Status: Active Grant

• Current Assignee: Stryker Corporation
• Original Assignee: Stryker Corporation
• Inventors: Strickler, Michael, Carusillo, Steven, Rodenkirch, Douglas, Smit, Karen, Gennrich, David
• Granted Patent: US 7,959,607 B2
• Time in Patent Office: Days
• US Class Current: 604/67
• CPC Class Codes: A61M 2005/14573 with a replaceable reservoir for quick connection/disconnection with a driving system
• CPC Class Codes: A61M 2205/3389 Continuous level detection A61M2205/3393 takes precedence
• CPC Class Codes: A61M 2210/1003 Spinal column
• CPC Class Codes: A61M 2230/50 Temperature
• CPC Class Codes: A61M 2230/60 Muscle strain, i.e. measured on the user
• CPC Class Codes: A61M 5/1456 with a replaceable reservoir comprising a piston rod to be moved into the reservoir, e.g. the piston rod is part of the removable reservoir
• CPC Class Codes: A61M 5/31566 Means improving security or handling thereof

Abstract

A fluid delivery device is provided for delivering fluid to a target site such as an intervertebral disc during discography. The fluid delivery device includes pressure and volume sensors to determine the pressure and the volume of the fluid delivered to the intervertebral disc. The fluid delivery device is hand-held during use and includes a syringe assembly having a plunger with threads that enables controlled discharge of the fluid from the fluid delivery device by rotating the plunger in a housing of the fluid delivery device. The fluid delivery device may also include a communication module to wirelessly transfer data to an external device outside of a sterile field, while the fluid delivery device is in the sterile field. The fluid delivery device may also include a physiological sensor to monitor involuntary pain responses based on changing physiological parameters such as increases in body temperature or blood pressure.

Claims

1. A fluid delivery device for delivering fluid to an intervertebral disc through a fluid conduit during a discography procedure and monitoring selected parameters of the fluid delivered to the intervertebral disc, said device comprising:

a housing including a reservoir for storing the fluid, said housing having a hand-held portion;

a manually actuated pump disposed in said housing and configured to pump fluid from said reservoir, said pump including a manual actuator;

a discography needle connected to said housing for receiving the fluid discharged by said pump, said discography needle shaped for percutaneous insertion into the intervertebral disc to direct the fluid into the intervertebral disc and having a length of at least 5 cm and an outer diameter of 16 gauge or smaller;

a pressure sensor disposed in said housing and positioned to sense the pressure of the fluid discharged by said pump, said pressure sensor producing a pressure signal representative of the sensed pressure;

a volume sensor disposed in said housing for sensing a volume of the fluid discharged by said pump, said volume sensor producing a volume signal representative of the volume of fluid discharged by said pump;

a controller disposed in said housing and connected to said pressure sensor for receiving the pressure signal and to said volume sensor for receiving the volume signal, said controller configured to;

based on the volume signal, determine the cumulative volume of fluid discharged by said pump; and

output signals representative of the pressure and volume of the fluid discharged by said pump;

a display mounted to said housing and in communication with said controller for receiving the output signals representative of the pressure and volume of discharged fluid, said display configured to, based on said controller output signals, display indications of the pressure and volume of fluid discharged by said pump; and

a battery disposed in said housing for actuating said pressure sensor, said volume sensor, said controller and said display,

wherein said housing, including said reservoir, said pump including said actuator, said pressure sensor, said volume sensor, said controller, said display and said battery cumulatively have a weight of 1.5 kilograms or less.

2. The device as set forth in claim 1, including a selectable volume tare switch attached to said housing and in communication with said controller and configured for resetting said value of the volume to zero upon actuation, so that said controller generates an output signal indicating the volume of fluid discharged by said pump after the resetting operation.

3. The device as set forth in claim 1, wherein said pump is a plunger that is mounted to said housing and has a head disposed in said reservoir.

4. The device as set forth in claim 3, wherein:

said plunger is formed with external threads;

an engagement mechanism is mounted to said housing for engaging said threads of said plunger in an engaged position to allow rotational advancement of said plunger in said reservoir and for disengaging from said threads in a disengaged position to allow slidable advancement of said plunger in said reservoir.

5. The device as set forth in claim 3, wherein said volume sensor includes a contact member operatively coupled to said plunger for rotating with said plunger relative to said housing during said rotational advancement and a plurality of sensing members fixed relative to said plunger such that the volume is measured based on said contact member being sensed by said plurality of sensing members as said contact member rotates with said plunger relative to said plurality of sensing members.

6. The device as set forth in claim 3, including an engagement detector in communication with said controller and responsive to said engagement mechanism to detect when said engagement mechanism is in said engaged position such that said controller measures the volume only when said engagement mechanism is in said engaged position.

7. The device as set forth in claim 1, including a selectable recall switch attached to said housing in communication with said controller, said controller having memory and configured to, upon actuation of said recall switch, retrieve from said memory saved pressure and volume data and output signals representative of the saved and recalled data to said display.

8. The device as set forth in claim 1, including a selectable key data switch attached to said housing in communication with said controller, said controller having memory and configured to store in said memory the current fluid pressure and volume data upon actuation of said key data switch.

9. The device as set forth in claim 1, wherein:

a communication module is attached to said controller for receiving output signals therefrom and is configured to wirelessly transmit the output signals to a receiver;

said battery providing energy to said communication module; and

wherein said housing, including said reservoir and said communication module, said pump including said actuator, said pressure sensor, said volume sensor, said controller, said display and said battery cumulatively have a weight of 1.5 kilograms or less.

10. The device as set forth in claim 9, wherein said communication module includes an infra-red LED.

11. The device as set forth in claim 9, wherein said housing, including said reservoir and said communications module, said pump including said actuator, said pressure sensor, said volume sensor, said controller, said display and said battery cumulatively have a weight of 0.5 kilograms or less.

12. The device as set forth in claim 1 wherein said controller is configured for determining a composite metric based on at least two of the pressure, the volume, and time and displaying said composite metric on said display.

13. The device as set forth in claim 1, wherein said pump is capable of discharging fluid into said discography needle at a maximum pressure of 200 psi.

14. The device as set forth in claim 1, wherein said housing, including said reservoir, said pump including said actuator, said pressure sensor, said volume sensor, said controller, said display and said battery cumulatively have a weight of 0.5 kilograms or less.

15. The device as set forth in claim 1, wherein said discography needle has a length of at least 12 cm and an outer diameter of 18 gauge or smaller.

16. The device as set forth in claim 1 wherein said controller includes memory for saving data during use, said data relating to the pressure, the volume, and time.

17. A system for delivering fluid to a target site during a medical procedure, monitoring selected parameters of the fluid delivered to the target site, and transferring data related to the monitored parameters, said system comprising:

a fluid delivery device adapted for being placed within a sterile field to deliver fluid to the target site during the medical procedure, said device including;

a housing defining a fluid chamber for storing the fluid to be delivered to the target site;

a plunger having a distal end disposed in said fluid chamber for discharging the fluid from said fluid chamber to the target site during the medical procedure as said plunger moves in said fluid chamber relative to said housing;

a pressure sensor for sensing a pressure of the fluid in said fluid chamber;

a volume sensor for sensing a volume of the fluid discharged from said fluid chamber; and

a controller in communication with said pressure sensor and said volume sensor for determining values of the pressure and the volume, said controller having memory for storing data related to said values of the pressure and the volume;

in combination with;

a data transfer system adapted for being placed outside of the sterile field and including an external device spaced from said fluid delivery device and configured for wirelessly receiving said data from said controller.

18. A fluid delivery device for delivering fluid to an intervertebral disc of a patient during a discography procedure, said device comprising:

a housing defining a fluid chamber for storing the fluid;

a plunger having a distal end disposed in said fluid chamber for discharging the fluid from said fluid chamber to the intervertebral disc during the discography as said plunger moves in said fluid chamber relative to said housing;

a pressure sensor for sensing a pressure of the fluid in said fluid chamber;

a physiological sensor for sensing a physiological parameter of the patient, said physiological parameter being uncontrollable by the patient;

a controller in communication with said pressure sensor and said physiological sensor for determining values of the pressure and said physiological parameter, said controller being configured for automatically marking a key value of the pressure in response to said value of said physiological parameter exceeding a predetermined limit wherein said predetermined limit correlates to a predetermined level of pain sensed by the patient and said value of said physiological parameter is unable to be controlled by the patient.