Fluid Delivery Device And A Method of Delivering Fluid

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 includes 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.

1 .- 9 . (canceled) 
     
     
         10 . A fluid delivery device for delivering a fluid to a patient during a 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 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 an involuntary physiological parameter of the patient;   a controller in communication with said pressure sensor and said physiological sensor, said controller is configured to determine values of said pressure and said involuntary physiological parameter,   wherein said controller is configured to automatically mark a key value of said pressure in response to said value of said involuntary physiological parameter exceeding a predetermined limit for said involuntary physiological parameter, and   wherein said predetermined limit of said involuntary physiological parameter is based on a pain magnitude scale.   
     
     
         11 . The fluid delivery device of  claim 10 , wherein said physiological sensor is configured to sense an involuntary physiological parameter selected from the group consisting of body temperature, blood pressure, muscle flex, heart rate, respiration, oxygen saturation, integumentary system, muscle tone, intracranial pressure, pupil size, vagal nerve tone, hormonal release, metabolic changes, and brain waves. 
     
     
         12 . The fluid delivery device of  claim 10 , wherein said physiological sensor is selected from the group consisting of a blood pressure sensor, a body temperature sensor, a muscle displacement sensor, and combinations thereof. 
     
     
         13 . The fluid delivery device of  claim 10 , wherein said physiological sensor comprises a plurality of physiological sensors configured to sense an involuntary physiological parameter. 
     
     
         14 . The fluid delivery device of  claim 10 , wherein said involuntary physiological parameter comprises a plurality of involuntary physiological parameters, and
 wherein values of said plurality of involuntary physiological parameters are monitored, and wherein said controller is configured to automatically mark said key value of said pressure in response to the values of said plurality of said involuntary physiological parameters.   
     
     
         15 . The fluid delivery device of  claim 10 , further comprising a readout, wherein said controller is in communication with a readout. 
     
     
         16 . The fluid delivery device of  claim 15 , wherein said readout is a moving graph, a light indicator, or a status bar. 
     
     
         17 . The fluid delivery device of  claim 10 , wherein said fluid delivery device is configured to discharge the fluid into an intervertebral disc, a vertebral body, or an inflatable member. 
     
     
         18 . A method of automatically marking a key value of pressure with a fluid delivery device, the fluid delivery device including a housing defining a fluid chamber for storing the fluid, a plunger having a distal end disposed in the fluid chamber for discharging the fluid from the fluid chamber as the plunger moves in the fluid chamber relative to the housing, a pressure sensor, a physiological sensor for sensing an involuntary physiological parameter of the patient, and a controller in communication with the pressure sensor and the physiological sensor for determining values of the pressure and the involuntary physiological parameter, said method comprising:
 discharging fluid from the fluid chamber;   sensing pressure of the fluid in the fluid chamber;   sensing the involuntary physiological parameter of the patient with the physiological sensor; and   automatically marking a key value of the pressure in response to the value of the involuntary physiological parameter exceeding the predetermined limit for the involuntary physiological parameter, wherein the predetermined limit of the involuntary physiological parameter is based on a pain magnitude scale.   
     
     
         19 . The method of  claim 18 , further comprising displaying the value of the sensed involuntary physiological parameter of the patient. 
     
     
         20 . The method of  claim 18 , wherein sensing the involuntary physiological parameter of the patient further comprises sensing the involuntary physiological parameter selected from the group consisting of body temperature, blood pressure, muscle flex, heart rate, respiration, oxygen saturation, integumentary system, muscle tone, intracranial pressure, pupil size, vagal nerve tone, hormonal release, metabolic changes, brain waves, and combinations thereof. 
     
     
         21 . The method of  claim 18 , wherein the step of sensing the involuntary physiological parameter of the patient comprises sensing a plurality of involuntary physiological parameters. 
     
     
         22 . The method of  claim 18 , wherein the step of sensing the involuntary physiological parameter of the patient comprises sensing a plurality of involuntary physiological parameters with a plurality of involuntary physiological parameters. 
     
     
         23 . The method of  claim 18 , wherein the step of sensing the involuntary physiological parameter of the patient further comprises sensing a plurality of involuntary physiological parameters, and
 wherein the step of automatically marking the key value of the pressure in response to the value of the involuntary physiological parameter exceeding a predetermined limit further comprises automatically marking the key value of the pressure in response to the values of the plurality of the involuntary physiological parameters.   
     
     
         24 . The method of  claim 18 , wherein the step of discharging fluid from the fluid chamber comprises discharging fluid to an intervertebral disc, a vertebral body, or an inflatable member. 
     
     
         25 . The method of  claim 19 , wherein the step of discharging fluid from the fluid chamber comprises discharging fluid to an intervertebral disc and wherein the patient is consciously unaware of which disk the fluid is discharged to. 
     
     
         26 . The method of  claim 19 , wherein the fluid is selected from the group consisting of contrast media, bone cement, a hydrogel, or saline.