Classifications

• • A—HUMAN NECESSITIES
  • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
  • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
  • A61M5/00—Devices for bringing media into the body in a subcutaneous, intra-vascular or intramuscular way; Accessories therefor, e.g. filling or cleaning devices, arm-rests
  • A61M5/14—Infusion devices, e.g. infusing by gravity; Blood infusion; Accessories therefor
  • A61M5/142—Pressure infusion, e.g. using pumps
  • A61M5/14212—Pumping with an aspiration and an expulsion action
  • A61M5/14228—Pumping with an aspiration and an expulsion action with linear peristaltic action, i.e. comprising at least three pressurising members or a helical member
• • A—HUMAN NECESSITIES
  • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
  • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
  • A61M5/00—Devices for bringing media into the body in a subcutaneous, intra-vascular or intramuscular way; Accessories therefor, e.g. filling or cleaning devices, arm-rests
  • A61M5/14—Infusion devices, e.g. infusing by gravity; Blood infusion; Accessories therefor
  • A61M5/142—Pressure infusion, e.g. using pumps
• • F—MECHANICAL ENGINEERING; LIGHTING; HEATING; WEAPONS; BLASTING
  • F04—POSITIVE - DISPLACEMENT MACHINES FOR LIQUIDS; PUMPS FOR LIQUIDS OR ELASTIC FLUIDS
  • F04B—POSITIVE-DISPLACEMENT MACHINES FOR LIQUIDS; PUMPS
  • F04B43/00—Machines, pumps, or pumping installations having flexible working members
  • F04B43/08—Machines, pumps, or pumping installations having flexible working members having tubular flexible members
  • F04B43/082—Machines, pumps, or pumping installations having flexible working members having tubular flexible members the tubular flexible member being pressed against a wall by a number of elements, each having an alternating movement in a direction perpendicular to the axes of the tubular member and each having its own driving mechanism
• • A—HUMAN NECESSITIES
  • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
  • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
  • A61M39/00—Tubes, tube connectors, tube couplings, valves, access sites or the like, specially adapted for medical use
  • A61M39/22—Valves or arrangement of valves
  • A61M39/28—Clamping means for squeezing flexible tubes, e.g. roller clamps
  • A61M39/281—Automatic tube cut-off devices, e.g. squeezing tube on detection of air

Definitions

• the present invention relates to medical devices, and more particularly, to an improved disposable infusion apparatus and peristaltic pump for delivering intravenous drugs at a controlled rate to a patient.
• the prior art includes devices that employ a bag filled with fluid medication that feeds by gravity through IV tubing having drip or other controllers. It is difficult for a patient to be ambulatory with a gravity fed infusion device and flow control is very limited.
• Another prior art infusion apparatus comprises an elastic bladder forming a liquid container mounted in an elongated cylindrical housing, a flow control valve, and tubing for supply of the liquid to the patient.
• the elastic walls of the bladder expand along the walls of the cylindrical housing when filled with the liquid, and provide the pressure for expelling the liquid.
• the bladder is typically filled by hand with a syringe which often requires an inordinate amount of force.
• Another drawback is that the bladder is forced to expand into an unnatural elongated configuration along the housing walls as it is filled. As a result of this unnatural configuration, the pressure of the bladder varies widely with the volume of liquid therein. Therefore, in most cases this type of elastic infusion apparatus does not have a reasonably stable pressure and flow rate over the infusion period.
• a peristaltic or other positive displacement pump which is electrically driven.
• Programmable infusion pumps have been provided having the capability for precise tailoring of the fluid delivery rate parameters in four different modes, namely, continuous, intermittent, PCA (patient controlled analgesic) and TPN (total parenteral nutrition) .
• PCA patient controlled analgesic
• TPN total parenteral nutrition
• a disposable infusion apparatus includes proximal, distal and intermediate segments of IV tubing connected via couplings.
• the intermediate segment has a length sufficient for operative engagement with a pumping member of a peristaltic pump throughout a pumping stroke thereof.
• the intermediate segment further has a maximum Durometer of seventy-five on the Shore A scale.
• the pumping member includes a plurality of fingers mounted in side-by-side substantially parallel relationship for individual reciprocation. Motor driven cams individually reciprocate respective ones of the fingers in a predetermined timed sequence so that when the linearly disposed intermediate segment is squeezed by the fingers, intravenous fluid in the tubing will be pumped therethrough.
• the disposable apparatus further includes a door connected to opposite ends of the intermediate segment and which is releasably loadable in a case to place the intermediate segment into operative engagement with the pumping member.
• Fig. 1 illustrates a programmable infusion system in phantom lines with a preferred embodiment of our disposable apparatus loaded therein.
• the disposable is shown connected to conventional IV tubing segments, an iv bag, a spike connector and a leur fitting.
• the IV tubing segments are broken at various locations to make this figure more compact.
• Fig. 2 is an enlarged fragmentary view of the programmable infusion system with the disposable apparatus installed therein and showing its relationship to a preferred embodiment of our peristaltic pump.
• Fig. 3 is a further enlarged view of the peristaltic pump and the door of the disposable.
• the IV tubing segments are not shown in this figure.
• Fig. 4 is an enlarged view of the three segments of tubing that form part of the disposable.
• Fig. 5 is an enlarged side elevation view of one of the fingers of the peristaltic pump showing how it squeezes shut the intermediate tubing segment of the disposable.
• Fig. 6 is a side elevation view of one of the cam wheels of the peristaltic pump. The motion of the cam wheel is illustrated in phantom lines.
• Figs. 7-9 illustrate details of the disposable door, tube clamp and IV tubing couplings. Best Mode for Carrying Out the Invention
• a programmable infusion system 10 which is adapted to utilize our disposable infusion apparatus and peristaltic pump. It includes a compact, portable rectangular case 12.
• the case may be made of injection molded plastic and may measure approximately seven inches in length by approximately three and one-half inches in width (right side in Fig. 1) by approximately one inch in thickness (right side in Fig. 1) .
• the preferred embodiment of our disposable IV tubing apparatus 14 may be releasably loaded or installed in a receptacle 16 (Fig. 2) in a long side edge of the case 12.
• the proximal end disposable IV tubing apparatus 14 is connected to a conventional spike 20 (Fig. 1) .
• the patient inserts the spike into a conventional bag 22 of intravenous fluid in which the desired medications are dissolved.
• the distal end of the disposable IV tubing apparatus 14 is connected to a conventional male leur fitting 26 which in turn connects to a conventional IV catheter (not illustrated) .
• a disposable IV fluid conveying means is a necessary requirement in an infusion system since i ensures sterility. It also prevents residual amounts of medication from one IV drug administration from being inadvertently delivered when a new IV drug administration commences.
• the preferred embodiment of our peristaltic pump 30 is mounted inside the case 12 adjacent the receptacle 16.
• a pumping member 32 of the- pump engages a linearly disposed intermediate segment 34 of the disposable IV tubing apparatus 14.
• the pumping member 32 comprises nine individual fingers 32a which slide back and forth toward and away from the intermediate IV tubing segment 34.
• the fingers 32a are moved by corresponding cam wheels 36 (Fig. 6) .
• a flexible boot 33 (Fig. 2 ) surrounds the fingers and forms an interface between the fingers and the intermediate segment 34 of IV tubing. The peripheral edges of this boot are sealed to internal walls of the case to protect the pump from contamination.
• Each cam wheel 36 (Fig. 5) has a splined mounting hole 37 therethrough which is offset from the center of the wheel.
• Each finger 32a comprises a rectangular block having a circular hole in which a corresponding one of the cam wheels 36 rotates.
• the hole has a diameter slightly larger than the outside diameter of the wheel so that the wheel can rotate inside the hole and thereby pull the finger back and forth.
• the motion of one of the cam wheels is illustrated in phantom lines in Fig. 6.
• the cam wheels 36 are mounted on a splined shaft 38 in progressive, offset alignment for individually reciprocating respective ones of the fingers 32a in a predetermined, timed sequence.
• the linearly disposed segment 34 of IV tubing is progressively squeezed by the fingers 32a so that intravenous fluid in the tubing is pumped therethrough.
• the intermediate IV tubing segment 34 is preferably made of vinyl or silicone and has a maximum Durometer of seventv-five measured on the Shore A scale.
• non-stiff disposable IV tubing apparatus 14 also ensures that less torque is required to rotate the splined shaft 38, thereby resulting in an overall reduction in energy consumption when the peristaltic pump is electrically driven from battery power as hereafter described.
• the fingers 32a preferably have small teats 32b
• Fig. 6 projecting from the ends thereof. These teats engage and squeeze the intermediate IV tubing segment 34. It has been determined that these teats ensure that the tubing segment 34 will be completely squeezed off during each cycle of each finger. It is important to understand that the intermediate tubing segment 34 must have a minimum amount of stiffness and resilience or else it will not open and close in a manner that will permit it to function as a peristaltic pump. Preferably the tubing segment 34 has a minimum Durometer of thirty-five measured on the
• the programmable infusion system 10 includes means for releasably mounting the intermediate IV tubing segment 34 adjacent the pumping member 32.
• the intermediate tubing segment 34 is mounted to a door 40 having a hook-shaped member 40a (Fig. 3) at one end and a compressible clasp 40b at the other end.
• the hook-shaped member 40a of the door may be engaged by the patient with a shoulder 16a (Fig. 2 ) located at one end of the receptacle 16 in the case 12.
• the other end of the door is then swung in and the clasp 40b snaps into the other end of the receptacle 16.
• the intermediate IV tubing segment 34 is squeezed between the individual fingers 32a and a compressible, resilient pad 42 (Figs. 3 and 6) supported by the innerside of the door 40.
• This pad may be made of polyurethane foam.
• the shaft 38 (Fig. 3) which supports the cam wheels 36 is journaled at opposite ends in ball bearings 44.
• a gear 46 rigidly mounted on one end of the shaft 38 meshes with another gear 48 (Fig. 2) rigidly mounted on another shaft 50 of a DC motor module 51 having an internal 141:1 gear reduction.
• one-hundred and forty-one rotations of the armature of the DC motor turns the shaft 50 one revolution and thus the cam shaft 38 one revolution.
• the disposable IV tubing apparatus 14 has a proximal tubing segment 52 and a distal tubing segment 54 connected to opposite ends of the intermediate IV tubing segment 34 by means of couplings 56 and 58. These couplings are attached to the underside of the door 40 as hereafter described in conjunction with Fig. 9.
• the intermediate IV tubing segment 34 preferably has an inside diameter of approximately 0.125 inches. Silicone and VINYL tubing can be commercially obtained having the desired stiffness.
• the proximal segment 52 and the distal segment 54 are each preferably made of clear polyvinyl chloride (PVC) having an outside diameter of approximately 0.140 inches and an inside diameter of approximately .088 inches. This clear PVC tubing is larger in both inside and outside diameter than the conventional PVC tubing segments 55a and 55b (Fig. 1) which connect the segments 52 and 54 to the spike 20 and male lure fitting 26, respectively.
• PVC polyvinyl chloride
• the designed maximum delivery rate is 5 approximately three hundred milliliters per hour.
• the minimum designed delivery rate is approximately 0.1 milliliters per hour.
• the delivery resolution is approximately 0.1 milliliters per hour for .01 through 99.9 milliliters per hour and approximately one
• VTBI designed maximum volume to be infused
• VTBI minimum volume to be infused
• KVO 15 designed "keep vein open” (KVO) rate is approximately one milliliter per hour for one through three hundred milliliter per hour rates and approximately 0.1 through 0.99 milliliters per hour for 0.1 through 0.99 milliliter per hour rates.
• the door 40 has a rectangular aperture 90 formed adjacent the hook-shaped member 40a.
• a resilient metal tubing squeezer 92 has an upper end 92a which is tightly received in the aperture 90 in the door 40.
• 25 squeezer 92 has a pair of parallel downwardly extending arms which terminate in coiled sections 92b. Referring to Fig. 8, when the disposable is assembled, the intermediate segment 34 is squeezed shut between the coiled sections 92b. When the door
• the clasp 40b consists of a V-shaped element.
• the door 40 is preferably made of injection molded plastic and the V-shaped clasp 40b is compressible upon swinging the clasp into the receptacle 16 in the case. This allows a wedge-shaped projection 96 on the clasp 40b to clear and snap into engagement behind an L-shaped latch 98.
• the coupling 56 is received in a slot in a bracket 102 which extends from the underside of the exterior wall of the door 40 near the clasp 40b.
• the coupling 56 is solvent, welded or bonded to the bracket 102.
• the coupling 58 is similarly received in another recess formed in the hook-shaped member 40a. Again the coupling 58 is solvent bonded to the member 40a.
• a magnet 106 (Fig.
• the Hall effect switch 108 (Fig. 3) adjacent the receptacle 16.
• the Hall effect switch is connected to the micro-controller hereafter described so that the output thereof will indicate whether or not a disposable has been correctly loaded into the case 12.
• the peristaltic pump 30 is a single channel, linear peristaltic pump having nine reciprocating fingers 32a.
• the intermediate IV tubing segment 34 is highly flexible as previously indicated. In a preferred embodiment of the disposable 14, the intermediate IV tubing segment 34 is made of silicone and has an inside diameter of approximately 0.125 inches. Approximately 0.12 milliliters of intravenous fluid are pumped through the intermediate IV tubing segment 34 for each single revolution of pump shaft 38.
• the combined motor and gear reduction module 51 also preferably includes a built-in motor encoder.
• One suitable unit is the MICRO-MO Model 1624006S. It uses TEFLON (Trademark) fixotropic lubricant.
• a conventional Robert's clamp 23 (Fig. 1) may be provided on the segment of conventional IV tubing 55b for closing off the same.

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• Health & Medical Sciences (AREA)
• Engineering & Computer Science (AREA)
• Hematology (AREA)
• Life Sciences & Earth Sciences (AREA)
• Vascular Medicine (AREA)
• Anesthesiology (AREA)
• Biomedical Technology (AREA)
• Heart & Thoracic Surgery (AREA)
• Veterinary Medicine (AREA)
• Public Health (AREA)
• Animal Behavior & Ethology (AREA)
• General Health & Medical Sciences (AREA)
• General Engineering & Computer Science (AREA)
• Mechanical Engineering (AREA)
• Infusion, Injection, And Reservoir Apparatuses (AREA)
• Reciprocating Pumps (AREA)

Applications Claiming Priority (2)

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• 1991
  • 1991-04-29 CA CA 2080370 patent/CA2080370C/fr not_active Expired - Fee Related
  • 1991-04-29 EP EP19910909243 patent/EP0527868A4/en not_active Ceased
  • 1991-04-29 JP JP91508693A patent/JPH05507007A/ja active Pending
  • 1991-04-29 WO PCT/US1991/002930 patent/WO1991016933A1/fr not_active Application Discontinuation

Patent Citations (2)

Non-Patent Citations (1)

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