# US 10,478,315 B2 · Apparatus and method for injecting bone graft substitute and other materials

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- Number: US 10,478,315 B2
- Document ID: US10478315B2
- Status: Granted
- Kind: B2
- Application number: 15/320,803
- Filed: 2015-06-24
- Published: 2017-07-13
- Granted: 2019-11-19
- Earliest claimed: 2014-06-24
- Assignees: The University of Toledo
- Applicants: The University of Toledo
- Inventors: Anand K. Agarwal; Vijay K. Goel; Joel M. Gerber; Aakash Agarwal
- Web page: https://patentgrep.com/patent/US10478315B2

## CPC

- A61F 2/4601: {for introducing bone substitute, for implanting bone graft implants or for compacting them in the bone cavity}
- A61B 17/8822: {characterised by means facilitating expulsion of fluid from the introducer, e.g. a screw pump plunger, hydraulic force transmissions, application of vibrations or a vacuum}
- A61B 17/8825: {characterised by syringe details (A61B17/8822, A61B17/8827 take precedence)}
- A61B 17/8827: {with filtering, degassing, venting or pressure relief means}
- A61M 5/14526: {the piston being actuated by fluid pressure}
- A61M 5/172: electrical or electronic
- A61M 5/20: Automatic syringes, e.g. with automatically actuated piston rod, with automatic needle injection, filling automatically (A61M5/142 takes precedence)
- A61M 5/2053: {Media being expelled from injector by pressurised fluid or vacuum (for infusion A61M5/145, A61M5/155)}
- A61M 5/486: {Indicating injection pressure}
- A61M 2005/14513: {with secondary fluid driving or regulating the infusion}
- A61F: FILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS (dental prosthetics A61C)
- A61B: DIAGNOSIS; SURGERY; IDENTIFICATION (usefulness limited to only animals A61D)
- A61M: DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY (introducing media into or onto the bodies of animals A61D7/00; means for inserting tampons A61F13/26; devices for administering food or medicines orally A61J; containers for collecting, storing or administering blood or medical fluids A61J1/05); DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY (surgery A61B; chemical aspects of surgical articles A61L); DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR {(Electrotherapy, e.g. producing anaesthesia by the use of alternating or intermittent currents A61N1/36021)}

## Abstract

A metering delivery apparatus for injecting bone graft cement includes a body portion, a material containment vessel, an actuator, and a control unit. The body portion includes a drive housing that supports an actuator drivetrain and receiver end that supports the material containment vessel. The actuator has a first end connected to the actuator drivetrain and a second end that supports a moveable portion of the vessel to dispense material in the vessel and a retracting movement that relieves pressure applied to the material. The control unit receives actuator parameter inputs and includes a sensor to detect a signal of at least one of a pressure level and a time period. The sensor provides the detected signal to the control unit such that the control unit operates the actuator between the dispensing and retracting movements based on the detected signal and the actuator parameter inputs.

## Claims

### Claim 1

A metering delivery apparatus comprising:
a body portion having a drive housing that supports an actuator drivetrain and receiver end;
a material containment vessel configured to dispense a quantity of material and supported on the receiver end such that a portion of the vessel is secured to the body portion and another portion of the vessel is moveable relative to the body portion;
an actuator having a first end connected to the actuator drivetrain and a second end configured to connect to and support the moveable portion of the vessel in both of a dispensing movement that exerts pressure on the material and a retracting movement that relieves pressure applied to the material; and
a control unit that receives actuator parameter inputs and includes a sensor to detect a signal of at least one of a pressure level and a time period, the sensor providing the detected signal to the control unit such that the control unit operates the actuator between the dispensing and retracting movements based on the detected signal and the actuator parameter inputs;
wherein the control unit includes a central processing unit (CPU) configured to receive the actuator parameter inputs and determine whether the detected signal is above or below a signal threshold value to operate the actuator and a display unit to display actuator operation parameters;
wherein the control unit includes a current sensor circuit configured to monitor a power consumption level of the actuator; and,
wherein the current sensor circuit detects at least one of an electrical current level flowing through the actuator and a voltage drop across the actuator during the dispensing and retracting movements, the circuit including an amplifier and a resistor, the CPU having an algorithm that determines the actuator power consumption from a voltage drop measurement from the actuator and a current level passing through the resistor.

### Claim 2 (depends on 1)

The metering delivery apparatus of claim 1 wherein the material containment vessel is a syringe having a barrel with a barrel flange and a plunger with a plunger flange, the receiver end having a slot that engages the barrel flange to secure the barrel to the body portion, the actuator having a connection point that engages the plunger flange for actuation between the dispensing and retracting movements.

### Claim 3 (depends on 1)

The metering delivery system of claim 1, wherein the amplifier is a high precision, single supply rail amplifier.

### Claim 4 (depends on 1)

The metering delivery system of claim 1, wherein the display is a touch screen display supported on the body portion, the touch screen configured to receive user inputs and display performance information, the body portion further including a hand grip having an actuator drive switch that initiates movement of the actuator to dispense the material.

### Claim 5 (depends on 4)

The metering delivery system of claim 4 wherein the actuator drive switch moves the actuator between an extended position corresponding to the dispensing movement and a retracted position corresponding to the retracting movement, the actuator drive switch forming an input signal to the CPU.

### Claim 6 (depends on 5)

The metering delivery system of claim 5 wherein the CPU detects a power consumption level of the actuator to determine whether to maintain the dispensing movement or initiate the retracting movement.

### Claim 7

A metering delivery apparatus comprising:
a body portion having a drive housing that supports an actuator drivetrain and receiver end;
a material containment vessel configured to dispense a quantity of material and supported on the receiver end such that a portion of the vessel is secured to the body portion and another portion of the vessel is moveable relative to the body portion;
an actuator having a first end connected to the actuator drivetrain and a second end configured to connect to and support the moveable portion of the vessel in both of a dispensing movement that exerts pressure on the material and a retracting movement that relieves pressure applied to the material; and
a control unit that receives actuator parameter inputs and includes a sensor to detect a signal of at least one of a pressure level and a time period, the sensor providing the detected signal to the control unit such that the control unit operates the actuator between the dispensing and retracting movements based on the detected signal and the actuator parameter inputs;
wherein the control unit includes a central processing unit (CPU) configured to receive the actuator parameter inputs and determine whether the detected signal is above or below a signal threshold value to operate the actuator and a display unit to display actuator operation parameters;
wherein the display is a touch screen display supported on the body portion, the touch screen configured to receive user inputs and display performance information, the body portion further including a hand grip having an actuator drive switch that initiates movement of the actuator to dispense the material;
wherein the actuator drive switch moves the actuator between an extended position corresponding to the dispensing movement and a retracted position corresponding to the retracting movement, the actuator drive switch forming an input signal to the CPU;
wherein the CPU detects a power consumption level of the actuator to determine whether to maintain the dispensing movement or initiate the retracting movement;
and
wherein the control unit includes a current sensor circuit configured to monitor a power consumption level of the actuator, the current sensor circuit sensing a voltage drop measurement from the actuator and a current level passing through a resistor of the current sensor circuit.

### Claim 8

A metering delivery apparatus comprising:
a body portion having a drive housing that supports an actuator drivetrain and receiver end;
a material containment vessel configured to dispense a quantity of material and supported on the receiver end such that a portion of the vessel is secured to the body portion and another portion of the vessel is moveable relative to the body portion;
an actuator having a first end connected to the actuator drivetrain and a second end configured to connect to and support the moveable portion of the vessel in both of a dispensing movement that exerts pressure on the material and a retracting movement that relieves pressure applied to the material; and
a control unit that receives actuator parameter inputs and includes a sensor to detect a signal of at least one of a pressure level and a time period, the sensor providing the detected signal to the control unit such that the control unit operates the actuator between the dispensing and retracting movements based on the detected signal and the actuator parameter inputs;
wherein the material containment vessel is a syringe having a barrel with a barrel flange and a plunger with a plunger flange, the receiver end having a slot that engages the barrel flange to secure the barrel to the body portion, the actuator having a connection point that engages the plunger flange for actuation between the dispensing and retracting movements;
wherein the actuator drivetrain includes a hydraulic piston/cylinder assembly, the control unit including a central processing unit (CPU) configured to receive the actuator parameter inputs and determine whether the detected signal is above or below a signal threshold, the sensor being a pressure sensor; and,
wherein the CPU includes an algorithm that determines whether the detected signal from the pressure sensor is above a low pressure level limit and receives a time period measurement of the dispensing movement of the actuator in response to the detected pressure sensor signal being less than the low pressure level limit, the CPU determining whether the time period measurement is below a time period threshold and maintaining the dispensing movement of the actuator in response to the time period measurement being less than the time period threshold.

### Claim 9 (depends on 8)

The metering delivery system of claim 8, wherein the CPU includes an algorithm that determines whether the detected signal from the pressure sensor is below a high pressure level limit and continues to permit the dispensing movement of the actuator in response to the detected signal being below the high pressure level limit.

### Claim 10

A metering delivery apparatus comprising:
a body portion having a drive housing that supports an actuator drivetrain and receiver end;
a material containment vessel configured to dispense a quantity of material and supported on the receiver end such that a portion of the vessel is secured to the body portion and another portion of the vessel is moveable relative to the body portion;
an actuator having a first end connected to the actuator drivetrain and a second end configured to connect to and support the moveable portion of the vessel in both of a dispensing movement that exerts pressure on the material and a retracting movement that relieves pressure applied to the material; and
a control unit that receives actuator parameter inputs and includes a sensor to detect a signal of at least one of a pressure level and a time period, the sensor providing the detected signal to the control unit such that the control unit operates the actuator between the dispensing and retracting movements based on the detected signal and the actuator parameter inputs;
wherein the material containment vessel is a syringe having a barrel with a barrel flange and a plunger with a plunger flange, the receiver end having a slot that engages the barrel flange to secure the barrel to the body portion, the actuator having a connection point that engages the plunger flange for actuation between the dispensing and retracting movements;
wherein the actuator drivetrain includes a hydraulic piston/cylinder assembly, the control unit including a central processing unit (CPU) configured to receive the actuator parameter inputs and determine whether the detected signal is above or below a signal threshold, the sensor being a pressure sensor; and,
wherein the control unit includes a current sensor circuit configured to monitor a power consumption level of the actuator, the current sensor circuit sensing a voltage drop measurement from the actuator and a current level passing through a resistor of the current sensor circuit, the CPU includes an algorithm that determines the actuator power consumption from a voltage drop measurement from the actuator and a current level passing through the resistor.

### Claim 11 (depends on 10)

The metering delivery system of claim 10 wherein the CPU includes an algorithm that determines whether the detected signal from the pressure sensor is above a low pressure level limit and then whether the detected signal from the pressure sensor is below a high pressure level limit in response to the detected pressure sensor signal being greater than the low pressure level limit and continues to permit the dispensing movement of the actuator in response to the detected signal being below the high pressure level limit.

### Claim 12

A metering delivery apparatus comprising:
a body portion having a drive housing that supports an actuator drivetrain and receiver end;
a material containment vessel configured to dispense a quantity of material and supported on the receiver end such that a portion of the vessel is secured to the body portion and another portion of the vessel is moveable relative to the body portion;
an actuator having a first end connected to the actuator drivetrain and a second end configured to connect to and support the moveable portion of the vessel in both of a dispensing movement that exerts pressure on the material and a retracting movement that relieves pressure applied to the material; and
a control unit that receives actuator parameter inputs and includes a sensor to detect a signal of at least one of a pressure level and a time period, the sensor providing the detected signal to the control unit such that the control unit operates the actuator between the dispensing and retracting movements based on the detected signal and the actuator parameter inputs;
wherein the material containment vessel is a syringe having a barrel with a barrel flange and a plunger with a plunger flange, the receiver end having a slot that engages the barrel flange to secure the barrel to the body portion, the actuator having a connection point that engages the plunger flange for actuation between the dispensing and retracting movements;
wherein the actuator drivetrain includes a hydraulic piston/cylinder assembly, the control unit including a central processing unit (CPU) configured to receive the actuator parameter inputs and determine whether the detected signal is above or below a signal threshold, the sensor being a pressure sensor; and,
wherein the hydraulic piston/cylinder assembly are a plurality of hydraulic piston/cylinder assemblies arranged to provide a force multiplying effect to the material containment vessel, the material containment vessel configured as a dual chamber vessel having a working fluid end and an injection syringe end.

### Claim 13 (depends on 10)

The metering delivery system of claim 10, wherein the CPU includes an algorithm that determines whether the detected signal from the pressure sensor is below a high pressure level limit and continues to permit the dispensing movement of the actuator in response to the detected signal being below the high pressure level limit.

### Claim 14 (depends on 12)

The metering delivery system of claim 12, wherein the CPU includes an algorithm that determines whether the detected signal from the pressure sensor is below a high pressure level limit and continues to permit the dispensing movement of the actuator in response to the detected signal being below the high pressure level limit.
