Infusion device

• US 4,652,260 A
• Filed: 03/11/1985
• Issued: 03/24/1987
• Est. Priority Date: 03/11/1985
• Status: Expired due to Fees

• Current Assignee: Maxxim Medical, Inc. (UBS Ag)
• Original Assignee: Strata Medical Incorporated
• Inventors: Miller, Robert L., Santin, Ernest M., Denis, Richard E., Fenton, Paul V. Jr., Young, Thomas M., Adaniya, George
• Primary Examiner(s): Pellegrino, Stephen C.
• Application Number:
  US06/710,009
• Time in Patent Office: 743 Days
• Field of Search: 604/67, 604/65, 604/66, 604/154, 604/155, 604/218, 604/131, 604/151, 128/DIG. 2, 128/DIG. 13, 222/333, 222/346, 222/386
• US Class Current: 604/67
• 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 5/172 electrical or electronic A61M5/16804, A61M5/16831 take precedence
• CPC Class Codes: Y10S 128/12 Pressure infusion

Abstract

An infusion device for a syringe includes a ratcheted stepper motor driven intermittently under the control of a control circuit to advance a syringe plunger driver. Different speeds are determined by the detected size of the syringe in the device. A clutch assembly disengageably connects the plunger driver to a drive belt driven by the stepper motor.

A connector for a tubing set has a syringe-connect portion located in a recess of the connector, and cooperates with a force sensor in the device to detect occlusions. The connector has annular projecting portions with parallel, spaced apart actuating surfaces for engagement of the force sensor in either of two positions of the connector in the device. The connector is adapted to indicate to a sensor in which position it is located.

Claims

1. An infusion device adapted for coupling to a syringe having an elongated tubular wall extending along a tube axis with a fluid dispensing outlet port at one end and having an internal plunger adapted for motion along said tube axis, comprising:

A. means for supporting said syringe wall whereby said tube axis is substantially parallel to a reference axis associated with said device,

B. means for selectively driving said plunger over a predetermined range of motion along said tube axis, including;

i. driver member for engaging said plunger,

ii. stepper motor having an output shaft, said motor being responsive to an applied pulse to rotate said shaft a predetermined angular increment in a first direction,

iii. coupling means for coupling said output shaft to said driver member whereby said driver member translates a predetermined linear increment along said reference axis in response to each of said incremental rotations of said shaft, and

iv. control means including a battery power supply and an associated electrical circuit means operative in a pump mode for generating a succession of said pulses, and for applying said succession of pulses to said motor, said circuit means being characterized by relatively high current drain from said power supply during said pulses and relatively low current drain from said power supply between said pulses,

wherein said coupling means includes;

i. a first roller and second roller,

ii. an endless belt disposed about said first and second rollers,

iii. motor coupler means for coupling rotory motion of said output shaft to said first roller, whereby said first roller rotates a predetermined angular increment and said belt translates a predetermined linear increment in response to each of said incremental rotations of said shaft,

iv. drive coupling means for selectively coupling said belt to said driver member.

2. An infusion device according to claim 1 wherein said driver coupling means includes a selectively operable clutch assembly, said clutch assembly being operative to decouple said driver means from said belt in response to an operator applied force, said clutch assembly being inoperative and said driver means being coupled to said belt otherwise.

3. An infusion device according to claim 2 wherein said belt has a ridged inner surface, said ridges extending transverse to the direction of said belt, and

wherein said clutch assembly includes a platen member overlying in a fixed relationship to the outer surface of said belt and includes a ridged clutch member wherein the ridges of said clutch member are complementary to the ridges of said belt, said ridged clutch member is positionable in a first position with said clutch member ridges engaging the ridges of said belt and positionable in a second position with said clutch member disengaged from said belt.

4. An infusion device according to claim 1 further comprising a sensor positioned on said support means and including means for generating a force signal representative of force applied thereto in the direction of said reference axis, and

wherein said control means includes circuitry responsive to said force signal for generating an alarm signal when said force signal is representative of a force above a predetermined threshold value.

15. An infusion device according to claims 1 or 5 or 9 further comprising a ratchet assembly coupled to said stepper motor, said ratchet assembly including means for permitting incremental rotational motion of said shaft in said first direction and for preventing rotational motions of said shaft having amplitude equal to or greater than said predetermined angular increment in the other direction.

16. An infusion device according to claim 15 wherein said stepper motor includes a rotatable armature and a stator, and wherein said ratchet assembly includes a saw-toothed rimmed disk member affixed to said armature and a ring element affixed to said stator, said ring element including a pawl extending inward thereof and in interfering engagement with said saw-toothed rim.

5. An infusion device adapted for coupling to a syringe having an elongated tubular wall extending along a tube axis with a fluid dispensing outlet port at one end and having an internal plunger adapted for motion along said tube axis, comprising:

A. means for supporting said syringe wall whereby said tube axis is substantially parallel to a reference axis associated with said device,

B. means for selectively driving said plunger over a predetermined range of motion along said tube axis, including;

i. driver member for engaging said plunger,

ii. stepper motor having an output shaft, said motor being responsive to an applied pulse to rotate said shaft a predetermined angular increment in a first direction,

iii. coupling means for coupling said output shaft to said driver member whereby said driver member translates a predetermined linear increment along said reference axis in response to each of said incremental rotations of said shaft, and

iv. control means including a battery power supply and an associated electrical circuit means operative in a pump mode for generating a succession of said pulses, and for applying said succession of pulses to said motor, said circuit means being characterized by relatively high current drain from said power supply during said pulses and relatively low current drain from said power supply between said pulses,

further comprising a sensor positioned on said support means and including means for generating a force signal representative of force applied thereto in the direction of said reference axis, and

wherein said control means includes circuitry responsive to said force signal for generating an alarm signal when said force signal is representative of a force above a predetermined threshold value.

6. An infusion device according to claim 5 further comprising:

A. an elongated flexible tube defining a central bore therethrough, and

B. a rigid connector member affixed to said tube and defining a linear central bore extending therethrough, said bores defining a continuous passageway, extending from an input port of said connector member, and said connector member and including means for coupling said input port to said outlet port of said syringe, and

wherein said connector member includes at least two support portions spaced apart along the axis of said connector member central bore and an interface portion connecting said support portions, and wherein the outer surfaces of said support portions are substantially identical in shape, said shape being adapted to interfit with said support member, whereby either of said support portions may be supported by said support member, and

wherein said connector member includes at least two actuating means for selective interfering engagement with said sensor.

7. An infusion device according to claim 6 wherein said actuating means includes at least two actuating surfaces for abutting engagement with said sensor.

8. An infusion device according to claim 7 wherein said actuating surfaces are spaced apart along the axis of said connector member central bore.

9. An infusion device adapted for coupling to a syringe having an elongated tubular wall extending along a tube axis with a fluid dispensing outlet port at one end and having an internal plunger adapted for motion along said tube axis, comprising:

A. means for supporting said syringe wall whereby said tube axis is substantially parallel to a reference axis associated with said device,

B. means for selectively driving said plunger over a predetermined range of motion along said tube axis, including;

i. driver member for engaging said plunger,

ii. stepper motor having an output shaft, said motor being responsive to an applied pulse to rotate said shaft a predetermined angular increment in a first direction,

iii. coupling means for coupling said output shaft to said driver member whereby said driver member translates a predetermined linear increment along said reference axis in response to each of said incremental rotations of said shaft, and

iv. control means including a battery power supply and an associated electrical circuit means operative in a pump mode for generating a succession of said pulses, and for applying said succession of pulses to said motor, said circuit means being characterized by relatively high current drain from said power supply during said pulses and relatively low current drain from said power supply between said pulses,

further comprising;

size means positioned on said support means for generating a syringe size signal representative of the size of said syringe, and

wherein said control means includes circuitry responsive to said syringe size signal to control the pulse repetition rate of said succession of pulses in a predetermined manner.

10. An infusion device according to claim 9 wherein said size means includes sensor means for sensing the position of said output port of said syringe and, further comprising:

A. an elongated flexible tube defining a central bore therethrough, and

B. a rigid connector member affixed to said tube and defining a linear central bore extending therethrough, said bores defining a continuous passageway, extending from an input port of said connector member, and said connector member and including means for coupling said input port to said outlet port of said syringe, and

wherein said connector member includes at least two support portions spaced apart along the axis of said connector member central bore and an interface portion connecting said support portions, and

wherein the outer surfaces of said support portions are substantially identical in shape, said shape being adapted to interfit with said support member, whereby either of said support portions may be supported by said support means,

wherein said connector member includes surface regions adapted for sensing by said sensor, each of said regions being representative of an associated one of said support portions being supported by said support means.

11. An infusion device according to claim 10 wherein said sensor is an optical sensor and said regions are characterized by differing optical reflectivity.

12. An infusion device according to claim 10 wherein said sensor is a mechanically actuated switch and said regions are characterized by different physical geometry.

13. An infusion device according to claim 10 wherein said sensor is a conductivity sensor and said regions are characterized by different electrical conductivity.

14. An infusion device according to claim 9 further comprising a sensor positioned on said support means and including means for generating a force signal representative of force applied thereto in the direction of said reference axis, and

wherein said control means includes circuitry responsive to said force signal for generating an alarm signal when said force signal is representative of a force above a predetermined threshold value.

17. An infusion device adapted for coupling to a syringe having an elongated tubular wall extending along a tube axis with a fluid dispensing outlet port at one end and having an internal plunger adapted for motion along said tube axis, comprising:

A. means for supporting said syringe wall whereby said tube axis is substantially parallel to a reference axis associated with said device,

B. means for selectively driving said plunger over a predetermined range of motion along said tube axis, including;

i. driver member for engaging said plunger,

ii. stepper motor having an output shaft, said motor being responsive to an applied pulse to rotate said shaft a predetermined angular increment in a first direction,

iii. coupling means for coupling said output shaft to said driver member whereby said driver member translates a predetermined linear increment along said reference axis in response to each of said incremental rotations of said shaft, and

iv. control means including a battery power supply and an associated electrical circuit means operative in a pump mode for generating a succession of said pulses, and for applying said succession of pulses to said motor, said circuit means being characterized by relatively high current drain from said power supply during said pulses and relatively low current drain from said power supply between said pulses,

wherein said syringe includes a laterally extending flange at the upstream end of said tubular wall, wherein the distance between said syringe outlet port and said upstream end is a predetermined value associated with the size of said syringe, said device further comprising;

A. an elongated flexible tube defining a central bore therethrough, and

B. a rigid connector member affixed to said tube and defining a linear central bore extending therethrough, said bores defining a continuous passageway, extending from an input port of said connector member, and said connector member and including means for coupling said input port to said outlet port of said syringe, and

wherein said connector member includes at least two support portions spaced apart along the axis of said connector member central bore and an interface portion connecting said support portions, and

wherein the outer surfaces of said support portions are substantially identical in shape, said shape being adapted to interfit with said support member, whereby either of said support portions may be supported by said support means, and

wherein said means for supporting said syringe further includes a first support member adapted to support one of said support portions and a second support member including a set of slots adapted for receiving said flange, each of said slots being a distance along said reference axis from said first support member associated with the size of said syringe.