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WO2007137194A2 - Pompe électromagnétique de faible consommation et dispositif de perfusion implantable comportant une telle pompe - Google Patents

Pompe électromagnétique de faible consommation et dispositif de perfusion implantable comportant une telle pompe Download PDF

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Publication number
WO2007137194A2
WO2007137194A2 PCT/US2007/069295 US2007069295W WO2007137194A2 WO 2007137194 A2 WO2007137194 A2 WO 2007137194A2 US 2007069295 W US2007069295 W US 2007069295W WO 2007137194 A2 WO2007137194 A2 WO 2007137194A2
Authority
WO
WIPO (PCT)
Prior art keywords
armature
fluid
housing
electromagnet
pump
Prior art date
Application number
PCT/US2007/069295
Other languages
English (en)
Other versions
WO2007137194A9 (fr
WO2007137194A3 (fr
Inventor
Theodore J. Falk
Norbert W. Frenz, Jr.
Peter C. Lord
Original Assignee
Infusion System, Llc,
Priority date (The priority date is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the date listed.)
Filing date
Publication date
Application filed by Infusion System, Llc, filed Critical Infusion System, Llc,
Publication of WO2007137194A2 publication Critical patent/WO2007137194A2/fr
Publication of WO2007137194A3 publication Critical patent/WO2007137194A3/fr
Publication of WO2007137194A9 publication Critical patent/WO2007137194A9/fr

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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
    • A61M5/14244—Pressure infusion, e.g. using pumps adapted to be carried by the patient, e.g. portable on the body
    • A61M5/14276—Pressure infusion, e.g. using pumps adapted to be carried by the patient, e.g. portable on the body specially adapted for implantation
    • 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
    • F04B17/00—Pumps characterised by combination with, or adaptation to, specific driving engines or motors
    • F04B17/03—Pumps characterised by combination with, or adaptation to, specific driving engines or motors driven by electric motors
    • F04B17/04—Pumps characterised by combination with, or adaptation to, specific driving engines or motors driven by electric motors using solenoids
    • F04B17/042—Pumps characterised by combination with, or adaptation to, specific driving engines or motors driven by electric motors using solenoids the solenoid motor being separated from the fluid flow
    • 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
    • A61M2205/00—General characteristics of the apparatus
    • A61M2205/82—Internal energy supply devices
    • A61M2205/8206—Internal energy supply devices battery-operated
    • A61M2205/8212—Internal energy supply devices battery-operated with means or measures taken for minimising energy consumption
    • 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
    • A61M5/14216—Reciprocating piston type

Definitions

  • small electromagnetic pumps are used for pumping liquids such as medicines, drugs, insulin, chemotherapy liquids, and other life critical drugs to a patient. These pumps are sometimes required to be quite small given the fact that they oftentimes will be implanted into the patient's body. If the pump is implanted, it is desirable that it have a low power requirement so that the battery which powers the electromagnetic pump has a long life.
  • the pump operate in a manner preventing damage to fragile drugs, such as insulin, and that moving parts of the pump be resistant to wear, thus prolonging the useful working life of the pump.
  • the low power electromagnetic pump operates at an extremely low power, and it may be used in implantable drug delivery systems, although the principles of this invention can be variously applied.
  • the low power electromagnetic pump may be employed in applications external to a patient's body.
  • the present invention provides an electromagnetic pump comprising a housing having an interior fluid containing region including a fluid receiving chamber in fluid communication with an inlet tube, a fluid output chamber in fluid communication with an outlet tube, and a check valve operatively associated with the fluid containing region for allowing fluid flow in a direction from the inlet tube toward the outlet tube and blocking fluid flow in a direction from the outlet tube to the inlet tube.
  • An electromagnet is carried by the housing and located external to the fluid containing region, and a barrier of fluid impervious material isolates the electromagnet from the fluid chambers of the pump.
  • An armature is positioned in the fluid containing region of the housing and comprises a pole portion located for magnetic attraction by the electromagnet, and the armature has a plunger portion extending from the pole portion.
  • the armature is supported in the housing for movement from a rest position through a forward pumping stroke when attracted by the energized electromagnet to force fluid from the output chamber through the outlet tube, and for movement in an opposite direction through a return stroke back to the rest position when the electromagnet is de-energized.
  • a retainer element can be joined to the armature, and a main spring can be captured between the retainer element and a retainer plate.
  • the main spring is for providing a biasing force during the return stroke. Guiding of the armature as it reciprocates is provided by the cooperation between the plunger portion and the adjacent housing of the pump, which is formed as a surrounding wall or cylinder in the pump housing.
  • the pump can be used for delivering an infusion medium to a patient.
  • the pump also has an interior fluid containing region, and the inlet and outlet tubes are in fluid communication with that region.
  • the electromagnet is located external to that fluid containing region of the housing, and is separated from the fluid containing region of the housing by a barrier.
  • the electromagnet can comprise a case and a core or coil spindle positioned inside the case.
  • the case and core comprise a magnetic material.
  • the case has a thickness, a length, and a diameter, and the core has a diameter and a length.
  • the case surrounds the coil and core, the case being spaced from the coil so as to be in insulated relation to the coil for example by encapsulant material such as potting compound or epoxy.
  • the ratio of the case diameter to the core diameter is in a range from about 2.5 to about 7, or is in a range from about 3.5 to about 7 or is about 3.5, and the ratio of the case length to the case diameter is in a range from about 1 .3 to about 2.3.
  • the case diameter can be less than about 0.28 inches so that the pump can be installed in an implantable drug delivery system.
  • the housing has a pump chamber which has a volume defined by a region within the housing surface bounded by the check valve, an axial end face of the plunger portion, and a bypass check valve. Also, a ratio of the volume of the pump chamber to a stroke volume is less than about 0.9 so as to enable the pump to move a liquid containing gas bubbles having a volume up to about 300 microliters against a pressure increase of at least five pounds per square inch.
  • the delivered stroke volume of the pump is between about 0.1 microliters to about 0.35 microliters.
  • the voltage supplied to the coil to energize the electromagnet ranges between about 1 .5 volts to about 6.0 volts.
  • the voltage supplied to the coil is terminated at time intervals ranging between about 1 millisecond to about 6 milliseconds. This time range can longer or shorter in other embodiments.
  • FIG. 1 is a longitudinal sectional view of the pump according to a preferred embodiment of the invention.
  • FIG. 2 is a diagrammatic view of the pump at rest with gap exaggerated.
  • FIG. 3 is a diagrammatic view of the pump showing one stage of the forward stroke.
  • FIG. 4 is a diagrammatic view of the pump showing a more forwardly stroke than FIG. 3.
  • FIG. 5 is a diagrammatic view of the pump showing the return stroke.
  • FIG. 6 is a schematic of the circuitry of the electromagnetic pump.
  • FIG. 7 is a graph further illustrating operation of the electromagnetic pump.
  • FIG. 8 is an enlarged fragmentary sectional view further illustrating the main check valve of the electromagnetic pump.
  • FIG. 9 is a plan view of an implantable infusion device in accordance with one embodiment of a present invention.
  • FIG. 10 is a plan view of the implantable infusion device illustrated in FIG. 9 with the cover removed.
  • FIG. 1 1 is a partial section view taken along line 1 1 -1 1 in FIG. 9.
  • FIG. 12 is a block diagram of the implantable infusion device illustrated in FIGS. 9-1 1.
  • the present inventions are related to low power electromagnetic pumps of the type shown in, for example, United States Patents Nos.
  • FIG. 1 shows a longitudinal sectional view of the pump 10.
  • the pump 10 comprises a body or housing 32 which may be embodied to have a cylindrical shape.
  • the housing 32 is generally hollow and has an fluid receiving chamber 15 at its inlet 19 that is in fluid communication with an inlet tube 14.
  • the housing 32 also has a fluid output chamber 17 at its outlet 21 that is in fluid communication with an outlet tube 20, and the fluid receiving and output chambers 15, 17, respectively, are in fluid communication with one another, as will be described presently.
  • fluid for example insulin, drugs, medications, chemotherapy drugs, and life critical drugs
  • fluid for example insulin, drugs, medications, chemotherapy drugs, and life critical drugs
  • FIG. 1 shows the pump 10 at rest, and the pumping cycle will be described in greater detail presently.
  • the inlet tube 14 receives incoming drugs, medicines, insulin, and other fluids to be moved by the pump 10.
  • the pump 10 contains an armature 45 having a plunger portion 49.
  • the inlet tube 14 is in fluid communication with and leads to a pump chamber 122 defined in the housing 32, that is the volume bounded by the inlet check valve 24, a bypass check valve 74, and an axial end face 53 of the plunger portion 49.
  • An armature shaft chamber 124 is defined in the housing 32, and it is sized to accommodate the pump armature
  • the armature shaft chamber 124 leads to and is in fluid communication with a main spring retainer chamber 126 having a diameter greater than the diameter of the armature shaft chamber 124.
  • the main spring retainer chamber 126 is in fluid flow communication with and leads to a pole button chamber 128 having a diameter greater than the diameter the main spring retainer chamber 126.
  • the pole button chamber 128 is in fluid flow communication with and leads to a flow passage 130, which is in fluid communication with the fluid output chamber 17.
  • an armature chamber 132 can be viewed as a combination of the armature shaft chamber 124, the main spring retainer chamber 126, and the pole button chamber 128.
  • the armature chamber 132 is sized such that the pump armature 45 can be positioned therein.
  • the housing 32 further defines, between the armature shaft chamber
  • a passage or orifice 44 defined in the housing 32 leads from the armature shaft chamber 124 to a plug chamber 134.
  • the orifice 44 provides for fluid communication between the armature shaft chamber 124 and the plug chamber 134.
  • the orifice 44 may be of relatively small diameter made by drilling and the like.
  • the plug chamber 134 leads to and is in fluid flow communication with bypass chamber 136.
  • the bypass chamber 136 is in fluid flow communication with the pole button chamber 128. These chambers thus provide for a bypass path or passage in the pump 10
  • the seat ferrule 56 shown in FIG. 1 is mounted to the housing 32 and joins to the inlet tube 14. It is noted that upstream of the seat ferrule 56 there is a reservoir of fluid to be pumped (not shown in the figures).
  • the pump armature 45 is located in the fluid containing region defined in the housing 32.
  • the armature comprises a pole portion 48 located for magnetic attraction by the electromagnet 100.
  • the plunger portion 49 is joined to and extends from the pole portion 48.
  • the armature pole portion 48 is located for movement within the pole button chamber 128 as shown in FIG. 1 .
  • the armature 45 is movably supported in housing 32 for movement from a rest position through a forward pumping stroke when attracted by the electromagnet 100 to force fluid out through outlet 21 , and for movement in an opposite direction through a return stroke back to the rest position. In FIG. 1 , armature 45 is shown at rest.
  • Armature pole portion 48 which occupies a major portion of the pole button chamber 128 in which it is positioned, is in the general form of a disc. It has a lateral dimension as viewed in FIG. 1 which is several times greater than the longitudinal dimension thereof.
  • Pole portion 48 comprises a solid, monolithic body of magnetic material having a first axial end face 50 that faces toward barrier or plate 51 and a second, opposite axial end face 52 that faces toward inlet tube 14.
  • first and second axial end faces 50, 52, respectively, of the pole portion 48 are disposed substantially perpendicular to the direction of travel of armature 45, as shown.
  • the pole portion 48 comprises a magnetic material, such as a heat treated chrome-molybdenum-iron alloy.
  • a heat treated chrome-molybdenum-iron alloy examples include 29-4 and 29-4C chrome-molybdenum iron alloy. These alloys have high corrosion resistance, and have adequate magnetic characteristics for use in the pump 10 when heat treated.
  • the alloy is heat treated to provide it with a BH characteristic that yields the requisite level of magnetic flux density and a relatively low level of coercive force, wherein B is the flux density and H is the magnetic field.
  • BH characteristics are well known to those having ordinary skill in the art.
  • the alloy is sufficiently resistant to corrosive effects of insulin stabilized for use in implantable drug delivery systems and does not harm the insulin or other drug to be used in the system.
  • the armature pole portion 48 terminates at the first end face 50 and serves as a pole face that faces the electromagnet 100.
  • the armature end face 50 together with electromagnet 100 define the magnetic circuit gap which is closed during the forward stroke of the armature 45.
  • the first end face 50 is of a relatively large cross-sectional area as compared to the cross sectional area of the armature plunger portion 49.
  • the plunger portion 49 of the armature 45 is movably positioned within the interior region of housing portion 32 and extends axially from armature pole portion 48 in a direction toward the inlet tube 14.
  • Plunger portion 49 is substantially cylindrical in shape having an outer diameter slightly less than the diameter of the interior passage in the housing 32 to allow reciprocal movement of plunger 49 within housing portion 32 during the forward and return strokes of armature 45.
  • the plunger portion 49 terminates in an axial end face 53 that faces in a direction toward the tube 14.
  • Plunger portion 49 has an enlarged, generally cylindrical formation 54 on the end adjacent pole portion 48 and which formation 54 has a diameter slightly greater than that of plunger portion 49.
  • annular head or enlargement 55 At the end of formation 54 adjacent pole portion 48 there is provided an annular head or enlargement 55.
  • the second axial end face 52 of pole portion 48 is provided with a recess 57 bordered by an annular peripheral flange 58.
  • the recess 57 is of a diameter sized to receive the outer end of the annular head or enlargement 55, and the recess 57 is surrounded by a flange 58.
  • the flange 58 is sized such that it can be crimped onto and over formation annular head or enlargement 55, as shown in FIG. 1 , thereby securely joining the armature plunger portion 49 and the armature pole portion 48.
  • the main check valve 24 is shown in FIG. 1 , positioned at the end of the armature shaft chamber 124.
  • the main check valve means 24 allows fluid from an upstream location, for example a reservoir, to enter the pump 10 when it is activated (the forward stroke of the pump 10).
  • the check valve 24 comprises a retainer 29 joined to a check valve element 27.
  • the check valve 24 opens allowing fluid from an upstream location, such as a reservoir, to enter the pump 10 through the inlet tube 14.
  • an upstream location such as a reservoir
  • the pump 10 is in the deactivated state, shown in FIGS. 1 and 2.
  • the pump armature 45 is drawn to the electromagnet 100 as will be described in connection with FIG. 2 (this shows the forward stroke of the pump 10).
  • the electromagnet 100 is isolated from the fluid being pumped by the barrier or plate 51 .
  • the plate 51 may be embodied as a thin plate-like diaphragm.
  • the plate 51 prevents fluids being pumped from contacting the parts and components of the electromagnet 100, or in other words, provides a fluid seal between the electromagnet 100 and the pump interior.
  • the electromagnet 100 serves to cyclically generate an electromagnetic field and is used to pull the armature 45 towards it when it is activated, which draws fluid into the pump 10.
  • the armature 45 returns to its at rest state (FIG. 1 ).
  • the check valve 24 is closed shortly after the armature 45 contacts plate 51 .
  • FIG. 1 also shows a retainer element 59.
  • the retainer element 59 comprises an annular body 60 having a lip portion 61 that extends about its periphery.
  • the retainer element 59 also defines a central opening or bore (not shown) into which the cylindrical formation 54 of the armature 45 is positioned.
  • the retainer element 59 is joined to the cylindrical formation 54 by welding, laser welding, friction fit, or combinations thereof.
  • FIG. 1 also shows a retainer plate 80, which defines a bypass fluid chamber opening 82, an outlet opening 84, and a central opening 86.
  • the central opening 86 is sized receive a crimped flange 58 that surrounds the annular enlarged head 55.
  • the retainer plate 80 also comprises an annular retainer plate flange 88 surrounding the central opening 86.
  • the outer weld ring 94 of the pump 10 comprises an annular support protrusion or lip 95.
  • the support protrusion 95 contacts a peripheral edge of the retainer plate 80.
  • the retainer plate 80 is thus positioned between the housing 32 and the support protrusion 95, and becomes trapped therebetween upon welding or joining the outer weld ring 94 and the housing 32. This prevents movement of the retainer plate 80 as the pump 10 cycles. Due to this configuration, the retainer plate 80 itself need not be welded.
  • the electromagnet 100 comprises a case 101.
  • a second weld ring 1 12 is provided on the case 101 adjacent the pump housing 32.
  • the outer diameter of the second weld ring 1 12 is substantially equal to the outer diameter of the outer weld ring 94, such that the respective outer surfaces are substantially flush.
  • the pump housing 32 and electromagnet case are placed in abutting relation on opposite sides of the barrier 51 .
  • the assembly is secured together by a weld joining the respective outer surfaces of the outer weld rings 94 and second weld ring 1 12.
  • the electromagnet case 101 houses a coil spindle or core 102.
  • the case 101 and core 102 are made from a magnetic material.
  • the case has a first case end 106 and a second case end 108.
  • the first case end 106 is joined to the pump housing 32 as described above, such that the core 102 is separated from the fluid containing region of the pump housing 32 by the barrier 51 .
  • a coil 104 comprising a wire or conductor is wound around the coil spindle or core 102.
  • a locator 105 is provided and it is joined to the core 102 adjacent the first case end 106.
  • a washer 107 also of magnetic material, is provided and it is joined to the other end of the core 102 adjacent the second case end 108.
  • a locator 105 is provided, and one of the purposes of the locator 105 and washer 107 is to center the core 102 within the case 101 during the potting process that is used to form the electromagnet 100.
  • potting compound, encapsulant material, or epoxy 109 is introduced into the case 101 .
  • the potting compound flows between the case 101 and coil 104, between the core 102 and coil 104, and between the conductors that make up the coil 104.
  • Potting compound 109 is well known to those having ordinary skill in the art.
  • the potting compound joins the coil 104 to the case 101 , the coil 104 to the core 102, and the conductors of the coil 104 to one another.
  • the cured potting compound 109 thus insulates and stabilizes the internal components of the electromagnet 100.
  • case 101 serves to space coil 104 from case 101 in an insulated manner.
  • insulated spacing of case 101 from coil 104 can be accomplished by other means such as insulated spacer components positioned between coil 104 and case 101 or by having washers like washer 107 at each end of the assembly and provided with inwardly extending annular flanges positioned to space and support coil 104 and case 101 relative to each other.
  • a body of potting compound or a potting cap 110 can be joined to a second end 108 of the electromagnet 100.
  • a pair of terminals 1 1 1 extends from the second end 108 of the electromagnet 100, and each of the terminals is surrounded by and insulated by the potting cap 1 10.
  • a conductor 1 14 is joined to each of the pair of terminals 11 1 .
  • the conductors 1 14 lead to a battery powered charging circuit 115 which is depicted in FIG. 1 as a box, and is shown in greater detail in FIG. 6.
  • the battery powered circuit 1 15 delivers pulses of energy to the pump in a manner to be described presently
  • the pulses of energy energize the electromagnet pump 100, and this causes the pole portion 48 of the armature 45 to be drawn toward the electromagnet 100, as shown in FIGS. 3 and 4.
  • the armature 45 compresses the main spring 90 as it moves towards the electromagnet 100.
  • fluid is drawn into the pump 10.
  • the electromagnet 100 is de-energized, the main spring 90 expands, as shown in FIG. 5, and applies force on the retainer element 59, which moves the armature 45 back to its at rest position in the pump 10 shown in FIG. 1 .
  • the efficiency of the pump 10 is increased by the electromagnet 100 and the magnetic components that make up the magnetic circuit, reducing the degree of saturation of the magnetic circuit at peak coil current.
  • the case diameter CD is less than about 0.28 inches so that the pump can be installed in, for example, an implantable drug delivery system. In all embodiments, the ratio of the case diameter, designated CD in
  • FIG. 1 to the core diameter S is in a range from about 2.5 to about 7, or is in a range from about 3.5 to about 7 or is about 3.5, and the ratio of the case length, designated CL in FIG. 1 , to the case diameter CD is in a range from about 1 .3 to about 2.3.
  • a plug 42 is mounted to the housing 32 in a plug chamber 134.
  • a bypass check valve 74 is positioned internal to the housing 32, between the orifice 44 and the bypass chamber 136.
  • Spring 76 is located between check valve element 78 and the end 43 of the plug 42.
  • the bypass check valve 74 controls fluid communication between the orifice 44 and bypass fluid chamber 136. That is, during the return stroke after the electromagnet 100 has been deactivated and the armature 45 begins to return to its starting position (rest position) shown in FIG. 1 , the bypass check valve 74 opens. Fluid from the armature shaft chamber 124 moves through the orifice 44, forces on element 78 and opens the bypass check valve 74. The fluid then moves into the bypass chamber 136.
  • the pumping cycle of the pump 10 is diagrammatically shown in FIGS. 2-5. Since the internal volume of the pump 10 does not change either during the pumping stroke or the return stroke in the absence of air within the pump 10, the volume of an incompressible fluid leaving the pump 10 is always equal to the volume of fluid entering the pump. As shown, when the armature 45 is in its rest position, no fluid flow passes through the inlet tube 14, because check valve 24 blocks fluid flow through the pump 10.
  • the electromagnet 100 is energized which creates a magnetic field in the vicinity of the plate barrier 51 (FIG. 3).
  • the armature 45 moves the distance of its stroke determined by the time when the electromagnet 100 deactivates (it de-energizes) and the return stroke, shown in FIG. 5, follows.
  • the armature 45 moves in the direction of the arrow designated 144 to its rest position as shown diagrammatically in FIG. 5. This movement is accomplished when main spring 90 releases its stored energy, which moves armature 45 toward check valve 24.
  • the check valve 24 closes prior to the return stroke, thus preventing any backflow of fluid out of the pump 10.
  • the pump 10 can comprise titanium, titanium alloys, and other non- corrosive materials, it is well suited for these applications.
  • the pump 10 can be used in combination with other implantable medical devices, and in combination with primary cell batteries, for example lithium batteries. It can also be used in combination with rechargeable power sources, for example rechargeable lithium batteries. It also can be used with capacitors rechargeable by radio frequency energy or other means.
  • Another use for the present pump 10 is in life critical situations as a means to deliver drugs, medicines, pain killers, wherein the pump 10 is located external to the patient. It is noted that the portion of the housing 32 that accommodates the plunger portion 49 is formed as a surrounding wall or cylinder 35 as shown in FIG. 4.
  • the plunger portion 49 is adjacent the cylinder 35 and is guided by the cylinder 35, so that no parts have to be aligned during assembly of the plunger portion 49 and housing 32. To allow for this, the plunger portion 49 has a greater length as compared with pistons/plungers used in other low power electromagnetic pumps. This increased plunger portion 49 length tends to reduce leakage between the cylinder wall 35 of the housing 32 and the plunger portion 49. Clearance between the cylinder 35 and the piston portion 49 can therefore be increased for ease of manufacture, while retaining the accuracy of the volume delivered by the pump 10.
  • Stroke volume is defined as the cross sectional area of plunger 49 times the total displacement of plunger 49 during the forward armature stroke. It is desired that the stroke volume be less than about 0.4 microliters.
  • Obtaining a desired stroke volume advantageously allows reduction of the amount of magnetic material in the pump, reduction in the degree of saturation in the pump magnetic circuit and increase in the stroke frequency associated with a fixed fluid delivery rate.
  • the armature pole portion 48 and plunger portion 49 are of fixed length, and the structural relationship thereof to housing 32 and/or components of the pump in the housing provides a selected stroke volume.
  • One way of accomplishing this is by precisely machining armature plunger 49 to the exact length for a desired stroke volume.
  • Another way is to provide one or more shims in housing 32. This affects the structural relationship between housing 32 and armature 49 thereby affecting the stroke volume.
  • One such shim is designated 64 and is installed between the plunger portion axial end face 53 and the main check valve 24. This reduces the manufacturing time required to arrive at the desired stroke volume, and as a result, the cost of the pump 10 is reduced.
  • check valve 24 i.e. by way of a pump component in housing 32.
  • the check valve assembly can be adjusted to change the axial location of the end face of check valve element 27 which contacts the plunger axial end face 53 when the armature is in the rest position. This, in turn, adjusts the extent of axial movement of plunger 49 thereby adjusting the stroke volume.
  • the attachment of the pole portion 48 to the plunger portion 49 has also been improved and simplified, in that the number of crimps in the flange 58 has been decreased from eight to six in one of the preferred embodiments.
  • the electromagnetic pump 10 also has simplified circuitry as shown in
  • FIG. 6, which is a schematic of the circuitry 1 19.
  • the circuit 1 15 that is capable of charging a capacitor 1 17 to the battery voltage.
  • the capacitor 1 17 can then be fully or partially discharged through the coil 104 to create a magnetic field so that pulses of energy can be delivered to the electromagnet 100 at timed intervals.
  • the circuit 1 15 includes a battery 116, a capacitor 1 17, a diode 1 18 in parallel with a pump coil 104, and first and second timer controlled switches 120, 121 , respectively.
  • the battery 1 16 is a lithium battery. When the first switch 120 is closed and second switch 121 is open, the capacitor 1 17 charges and stores energy in an electric field.
  • the first switch 120 is opened and the second switch 121 is closed such that the charge from the capacitor 1 17 is rapidly delivered to the coil 104.
  • the diode 1 18 provides a current path for the coil current to flow through, and this allows the stored energy of the coil 104 to be slowly dissipated. This decreases the likelihood of a voltage spike when the second switch 121 opens which protects the components of the circuit components described above.
  • the minimum capacitance required to drive the pump, Cmin can be expressed as
  • the capacitor energy retained at the end of the pulse driving the solenoid is not lost between pulses.
  • the capacitor must therefore have low leakage. It also must have capacitance significantly higher than the minimum required to drive the solenoid and, therefore, should have high energy density to avoid occupying excessive space on the circuit board. This requires a capacitor with relatively high capacitance, which must have low leakage so that the charge is not lost between pulses.
  • a solid tantalum capacitor is suitable for this purpose.
  • the pump 10 is designed to deliver 0.25 microliters per pulse rather than the 0.5 microliters per pulse delivered by other low power electromagnetic pumps. For a given rate of drug delivery, the pump 10 operates at twice the pulse frequency of the other pumps and requires less than 50% of the energy per pulse. The small pulse volume both shortens the time interval between pulses and requires less energy to be delivered by the capacitor.
  • the pump 10 can be operated efficiently at least over the range of voltages from about 1 .5 volts to about 6.0 volts by terminating the external voltage to the coil 104 at suitable time intervals.
  • the time ranges between about 1 millisecond to about 6 milliseconds. The time range can be longer or shorter in other embodiments.
  • this voltage range could be shifted to higher or lower values as required.
  • the pump 10 is able to deliver accurate pulse volumes when operated with a wide range of catheter designs. This has been accomplished by specifying a soft accumulator to ensure that the catheter-accumulator combination does not generate a negative pressure pulse strong enough to draw additional fluid volume through the pump 10.
  • a soft accumulator to ensure that the catheter-accumulator combination does not generate a negative pressure pulse strong enough to draw additional fluid volume through the pump 10.
  • the stroke volume delivered by the pump 10 is reduced from the 0.5 microliters delivered by the other pumps to about 0.25 microliters.
  • MRI magnetic resonance imaging
  • the coil 104 delivers fewer ampere-turns to the magnetic circuit. This makes it possible to both reduce the coil 104 volume and to reduce the degree of saturation of the magnetic circuit, thus improving the efficiency of the pump 10.
  • the smaller stroke volume of the pump 10 compared with the earlier low power electromagnetic pumps could have been obtained by shortening the stroke length, by reducing the piston diameter, or by a combination of both. Shortening the stroke length would have increased the energy efficiency. This would, however, also have increased the difficulty of setting the stroke volume precisely, increased the effect of seat wear on the stroke volume, and increased the pump chamber dead volume, which would have consequently increased the difficulty associated with pumping bubbles.
  • the nominal stroke length of the pump 10 can be selected to be the same as prior pumps, in which case the reduction in stroke volume is obtained almost entirely by decreasing the diameter of the plunger portion 49. In other embodiments, it may be feasible to reduce the stroke length by about 50%, thus reducing the stroke volume to about 0.1 microliters.
  • the inlet check valve 24 design is improved over past check valves.
  • the initial motion of the plunger is inhibited by the fact that the opening of the check valve 24 is limited by the motion of the piston.
  • This effect is reduced in the pump 10 because the diameter of the check valve 24 is increased relative to diameter of the plunger portion 49.
  • the ratio of the sealing diameter of portion 65 of check valve 24 to the diameter of end face 53 of the armature plunger is greater than about 0.6 to reduce inhibiting the initial motion of armature plunger 49.
  • the pump 10 can pump against a normal 6 (six) pounds per square inch (hereinafter p.s.i.) pressure head. This is higher than the 4 p.s.i. considered normal for other low power electromagnetic pumps. Operation against the higher pressure head increases the safety margin should a patient travel to a high altitude and the pump develop a leak. So long as the pressure of the reservoir that supplies the pump 10 is less than the ambient pressure, a leak across the pump may disable the pump 10 but it will not cause life- threatening overdelivery of drug.
  • p.s.i. pounds per square inch
  • the pump 10 is used in a drug delivery application in which it is implanted in a human body, and the pump 10 is used for the delivery of liquid. This assists in ensuring that under normal conditions no air will enter the pump 10. However, if some air should enter into the pump it is desirable that the pump 10 continue to operate so that it passes any air bubble and resumes delivery of the drug. Failure to do so might require that the pump 10 be explanted from the patient or some other intervention to resolve bubble problems. The ability of the pump 10 to continue to operate when air is present within the pump depends upon several factors.
  • the volume of air retained within the pump chamber 122 at rest must be small enough compared with the stroke volume so that the pressure decrease within the pump chamber during the pumping stroke is sufficient to open the inlet check valve and draw flow into the pump chamber 122.
  • the required pressure decrease is the pressure increase against which the pump 10 is operating combined with the pressure differences required to open the two check valves. It is noted that if the pump 10 failed to meet this criterion, then even a very small bubble (comparable in volume to the pump
  • the ability of the pump 10 to move air has been increased beyond that of the other pumps by reducing the volume of the pump chamber 122, i.e., the volume bounded by the inlet check valve 24 (end face 65 of the check valve element), the bypass check valve 74 (orifice 44 and the included portion of the valve element end face) and the axial end face 53 of the plunger portion 49.
  • the pump can pump continuously while passing bubble volumes up to about 300 microliters.
  • a ratio of the volume of the pump chamber to the stroke volume is less than about 0.9 so as to enable the pump to move liquid containing gas bubbles having a volume up to about 300 microliters against a pressure increase of at least five pounds per square inch. Pumping did not fail after passage of this volume of air and it is probable that the pump 10 is capable of pumping still larger bubbles.
  • the pressure in the pump chamber 122 may be equal to the outlet pressure of the pump 10 or it may be equal to the sum of the outlet pressure and the pressure required to hold the bypass check valve open. This depends upon how quickly and completely the bypass check valve seals at the end of the return stroke and whether there is a significant leak between the plunger portion 49 and cylinder 35 between pump pulses. The calculation proceeds by determining first how far the plunger portion 49 must travel before the pressure in the pump chamber 122 decreases to a low enough value to open the main check valve 24. This depends in part on the specific heat ratio, Y, of the gas.
  • ⁇ Pbcv is the pressure drop across the bypass check valve 74
  • ⁇ Pmcv is the pressure drop across the main check valve 24
  • Poutiet is the delivery pressure
  • Pinlet is the inlet pressure.
  • the accuracy of other low power electromagnetic pumps depends, in part, on the presence of an orifice in the outlet tube that limits the speed at which the plunger may pull an accumulator of relatively low compliance located at the end of the outlet tube. In that case, the pressure drop across the orifice and the back pressure which develops in the accumulator during the stroke combine to reduce the inertial overdelivery of fluid when the pressure increase across the pump is small or negative.
  • a bubble passes through one of these other pumps, it first reduces the fluid delivery per stroke while the bubble is located within the pump chamber. Relatively quickly the bubble passes from the pump chamber into the pump body, where it is usually trapped until it redissolves in the passing flow.
  • the pump may tend to overdeliver fluid because the bubble in the pump body provides compliance upstream of the orifice negating the effect of the orifice in limiting the piston speed and the flow rate.
  • the pump 10 is designed to have relatively short inlet and outlet tubes, 14, 20, respectively, as compared to those of other low power electromagnetic pumps, and these result in reduced inertial flow.
  • the pump 10 can include an accumulator designed to have relatively large compliance so that the difference between the pulse volume delivered by the pump 10 with a bubble in the pump body 32 and with only fluid in the pump body 32 is relatively small.
  • the pump 10 may be provided with a compliant element within the pump body 32 to further reduce the inaccuracy associated with inertial flow.
  • the pump 10 incorporates a bypass circuit 37 around the plunger portion 49. This serves several purposes. It allows passage of air through the pump 10 without breaking down the liquid seal, which inhibits leakage of air through the plunger portion 49 and cylinder 35. Efficient pumping of air by the pump 10 relies upon maintenance of this liquid seal. Another purpose of the bypass circuit 37 is to allow rapid return of the piston portion 49 to its rest position after the pumping stroke. This is of importance primarily in applications of the pump 10, which require rapid pumping rates.
  • the performance of the pump mechanism is dependent on the piston-cylinder seal, i.e. the liquid seal between the outer surface of armature plunger portion 49 and the inner surface of cylinder 35.
  • This seal may be comprised of if air enters the piston- cylinder interface, i.e. the space or clearance between the outer surface of armature plunger portion 49 and the inner surface of cylinder 35.
  • the mechanism depends on this seal in both the forward pumping stroke and the return stroke.
  • the piston-cylinder seal sustains suction in the pump chamber 122 while at the same time resisting the pressure required to push fluid or air from the outlet chamber 17 into the outlet tube 20 which may be in fluid communication with an accumulator/catheter.
  • Air retained in the outlet chamber 17 is at a higher pressure than the negative pressure created in the pump chamber 122 and thus tends to enter the piston-cylinder interface from the outlet chamber side. It will enter the piston-cylinder interface if the pressure exceeds the bubble point of this space. If this happens the pump mechanism will not be able to sustain suction in the pump chamber 122 or push out fluid. The stoke volume will be significantly diminished or will go to zero at low reservoir pressures.
  • the pump chamber volume stroke volume ratio; 2.
  • Each of these parameters can be enhanced by choosing materials and surfaces which are hydrophilic and in the case of bubble point, by decreasing the piston-cylinder gap or interface.
  • the dead space in the pump chamber volume and the retention of fluid in the dead spaces can be addressed using hydrophilic materials or coatings. Hydrophilic surfaces in small cracks can draw in water and will retain water tenaciously. Less viscous hydrophilic coating materials will actually fill in cracks and other small spaces and decrease the dead volume of the pump chamber 122 thus increasing the pump chamber volume: stroke volume ratio.
  • the piston-cylinder interface bubble point must resist air entry from the outlet chamber 17 during the forward stroke and must resist air entry from the pump chamber 122 during the return stroke. If the bubble point is too low during the forward stroke and air enters the piston-cylinder interface, the pump may not develop enough pressure to open the main check valve 24. If air enters the piston-cylinder interface during the return stroke, the bypass check valve 74 may open late or not at all and the volume of air pumped will be small. Bubble point is strongly affected by the size of the interface and by the hydrophilicity of the interior surfaces of the interface. Bubble point is increased by decreasing the clearance between the piston and the cylinder and by making the surface of the piston and cylinder more hydrophilic using coatings, or surface treatments, or simply by using materials which are intrinsically hydrophilic.
  • Coating materials may be poly ethylene glycol (PEG), acrylic or other forms of hydrogels or any other hydrophilic coating.
  • Solvent based coatings can be used to enter and fill fine cracks and crevices.
  • Plasma treatments and abrasive treatments may be used to enhance the hydrophilic nature of surfaces.
  • Materials such as titanium, sapphire and glass which are naturally hydrophilic are currently used, however aggressively hydrophilic coatings such as the hydrogels or PEG mentioned above could have a dramatic effect would significantly improved the low pressure pumping capability of the pump.
  • the pump 10 and other low power electromagnetic pump designs allow the main check valve 24 to be held closed at rest by a strong return spring.
  • the force of the return spring 90 is immediately removed from the main check valve 24 and the check valve 24 is then held closed by the weak check valve spring 25.
  • the strong return spring 90 prevents leakage back through the pump 10 between pumping strokes and is essential if the pump 10 is to deliver accurate small fluid volumes.
  • the weak spring 25, which tends to hold the check valve 24 closed during the pumping stroke but which allows the check valve 24 to open with a minimal pressure difference in the flow direction, is important to the efficient pumping of air.
  • the simplified structure and method of assembly of the pump of this invention advantageously reduce cost of manufacture.
  • the various characterizing features of the pump described hereinabove contribute to its enhanced energy and operational efficiency.
  • the pump of this invention requires less than 50% of the energy per pulse required by pumps heretofore available. For example, it has been determined that the energy required by the pump described herein to pump a unit volume is 4 millijoules/microliter whereas the pump described in United States Patent
  • FIGS. 1-10 One example of an implantable infusion device in accordance with a present invention is generally represented by reference numeral 200 in FIGS.
  • an "implantable infusion device” is a device that includes a reservoir and an outlet, and is sized, shaped and otherwise constructed (e.g. sealed) such that both the reservoir and outlet can be simultaneously carried within the patient's body.
  • the exemplary infusion device 200 includes a housing 202 (e.g. a titanium housing) with a bottom portion 204, an internal wall 206, and a cover 208.
  • An infusible substance e.g. medication
  • the reservoir 210 may be replenished by way of a refill port 212 that extends from the reservoir, through the internal wall 206, to the cover 208.
  • a hypodermic needle (not shown), which is configured to be pushed through the refill port 212, may be used to replenish the reservoir 210.
  • the reservoir 210 is in the form of a titanium bellows that is positioned within a sealed volume defined by the housing bottom portion 204 and internal wall 206. The remainder of the sealed volume is occupied by propellant P, which may be used to exert negative pressure on the reservoir 210.
  • Other reservoirs that may employed in the present infusion devices include reservoirs in which propellant exerts a positive pressure.
  • Still other exemplary reservoirs include negative pressure reservoirs that employ a movable wall that is exposed to ambient pressure and is configured to exert a force that produces an interior pressure which is always negative with respect to the ambient pressure.
  • the exemplary ambulatory infusion device 200 illustrated in FIGS. 9-12 also includes the above-described pump 10.
  • the pump inlet tube 14 is coupled to the interior of the reservoir 210, while the outlet tube 20 is coupled to an outlet port 218 by a passageway 220. Operation of the pump 10 causes infusible substance to move from the reservoir 210 to the outlet port 218.
  • a catheter 222 may be connected to the outlet port 218 so that the infusible substance passing through the outlet port will be delivered to a target body region in spaced relation to the infusion device 200 by way of the outlet 224 at the end of the catheter.
  • the capacitor 1 17 (as well as some other aspects of the circuitry 1 19 illustrated in FIG. 6) are carried on a board 230.
  • a communication device 232 which is connected to an antenna 234, is carried on the same side of the board 230 as the capacitor 1 17.
  • the exemplary communication device 232 is an RF communication device.
  • Other suitable communication devices include, but are not limited to, oscillating magnetic field communication devices, static magnetic field communication devices, optical communication devices, ultrasound communication devices and direct electrical communication devices.
  • a controller 236 (FIG. 12), such as a microprocessor, microcontroller or other control circuitry, is carried on the other side of the board 230.
  • the controller controls the operations of the infusion device 200 in accordance with instructions stored in memory and/or provided by an external device (e.g. a remote control) by way of the communication device 232.
  • the controller 236 may be used to control the circuitry 1 19 such that fluid is supplied to the patient in accordance with, for example, a stored basal delivery schedule or a bolus delivery request.
  • the controller 236 may also be used to monitor sensed pressure in the manner described below.
  • the exemplary infusion device 200 is also provided with a side port 240 that is connected to the passageway 220.
  • the side port 240 facilitates access to an implanted catheter 222, typically by way of a hypodermic needle.
  • the side port 240 allows clinicians to push fluid into the catheter 220 and/or draw fluid from the catheter for purposes such as checking catheter patency, injecting contrast dye into the patient, and/or injecting additional medication into the region at the catheter outlet 224.
  • the outlet port 218, a portion of the passageway 220, the antenna 234 and the side port 240 are carried by a header assembly 242.
  • the header assembly 242 is a molded, plastic structure that is secured to the housing 202.
  • the housing 202 includes a small aperture through which portions of the passageway 220 are connected to one another, and a small aperture through which the antenna 234 is connected to the board 230.
  • the exemplary infusion device 200 illustrated in FIGS. 9-12 also includes a pressure sensor 244 that is connected to the passageway 220.
  • the pressure sensor 244 senses the pressure at the outlet port 218 which, in the illustrated embodiment, is also the pressure within the catheter 222.
  • the pressure sensor 244 is connected to the controller 236 and may be used to analyze a variety of aspects of the operation exemplary implantable infusion device 200. For example, pressure measurements may be used to determine whether or not the pump 10 is functioning properly and whether or not there is a complete or partial blockage in the catheter 220.
  • the controller 236 may perform a variety of different functions in response to determination that the pump 10 is not functioning properly and/or the catheter 222 is blocked. For example, the controller 236 may actuate an audible alarm (not shown) that is located within the housing 202 in order to signal that the pump 10 is not functioning properly and/or the catheter 222 is blocked.

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

Abstract

La présente invention concerne une pompe électromagnétique comportant un induit comprenant une partie polaire et une partie piston, la partie piston dimensionnée pour être reçue dans un passage de forme cylindrique formé dans le corps et guidant l'induit. La pompe comporte également un électro-aimant associé en fonctionnement à l'induit, et la pompe est entraînée lors d'une course de pompage vers l'avant par la décharge partielle d'une capacité pour pénétrer dans l'électro-aimant. Le boîtier de l'électro-aimant est dimensionné de sorte qu'un rapport du diamètre du boîtier au diamètre du noyau et un rapport de longueur du boîtier au diamètre du boîtier assurent une efficacité électromagnétique améliorée.
PCT/US2007/069295 2006-05-19 2007-05-18 Pompe électromagnétique de faible consommation et dispositif de perfusion implantable comportant une telle pompe WO2007137194A2 (fr)

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US11/437,571 US20070269322A1 (en) 2006-05-19 2006-05-19 Low power electromagnetic pump
US11/437,571 2006-05-19

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US8251960B2 (en) 2007-03-24 2012-08-28 The Alfred E. Mann Foundation For Scientific Research Valves, valved fluid transfer devices and ambulatory infusion devices including the same
US7976500B2 (en) * 2008-06-26 2011-07-12 Calibra Medical, Inc. Disposable infusion device with redundant valved safety
US9968733B2 (en) * 2008-12-15 2018-05-15 Medtronic, Inc. Air tolerant implantable piston pump
DE102009008082B3 (de) * 2009-02-09 2010-06-02 Compact Dynamics Gmbh Bremsaggregat einer schlupfgeregelten Kraftfahrzeug-Bremsanlage mit einer Fluidfördereinrichtung
US8197454B2 (en) * 2009-02-21 2012-06-12 Incumed, Llc Fluid cartridges and partially implantable medical devices for use with same
US9370619B2 (en) * 2009-02-21 2016-06-21 Incumed, Llc Partially implantable medical devices and delivery/manifold tube for use with same
US20100217243A1 (en) * 2009-02-21 2010-08-26 Mann Alfred E Partially implantable medical devices and treatment methods associated with same
US9125981B2 (en) * 2009-02-21 2015-09-08 Incumed, Llc Fluid cartridges including a power source and partially implantable medical devices for use with same
EP2878819A3 (fr) * 2013-11-28 2015-10-21 Teylor Intelligent Processes SL Électro-aimant arrière adapté pour pompes vibrantes et valves
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WO2007137194A9 (fr) 2008-12-24
WO2007137194A3 (fr) 2008-04-03

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