This application is the U.S. national stage application of International Patent Application No. PCT/IB2011/051071, filed Mar. 15, 2011, the disclosure of which is hereby incorporated by reference in its entirety, including all figures, tables and amino acid or nucleic acid sequences.
The present invention relates to a micropump with a rotatably and axially movable rotor. The micropump may be used, inter alia, in medical applications for the administration of drugs, in non-medical applications or for diagnostic purposes.
A micropump for precise administration of small quantities of a liquid or pasty liquid is described in international applications WO2005039674 and WO2007074363. The rotational and axial movement of the rotor relative to the housing creates a pumping action while opening and closing valves to draw liquid into the pump and to expel liquid from the pump. A curve on the rotor cooperating with a complementary cam on the housing causes the axial displacement of the rotor when one of the valves is open. When both valves are closed, axial displacement of the rotor should be essentially nil subject to a certain elasticity of the chamber containing the liquid, the liquid being essentially incompressible. The presence of air in the pump or of occlusions hindering the flow of the liquid downstream of the pump may affect the axial displacement of the rotor and the pumping characteristics of the pump.
In many medical applications, such as the transcutaneous or intravenous delivery of liquid drugs, the presence of air in the liquid to be administered is highly undesirable. In drug delivery systems there may also be occurrences of occlusion, for example due to blood clotting or crushing of catheter tubing or more generally application or build-up of a back-pressure, or of leakage. In many conventional systems, separate pressure sensors are installed in the system with a view of detecting occlusion or leakage however such systems are usually not adapted to detect reliably air bubbles. Moreover, the presence of separate sensors complicates the pump system and renders it more complex and costly to operate. The pump and pressure sensors being separate, there is also a certain risk that the sensors may function incorrectly without being noticed without discontinuing the operation of the pump.
The detection of occlusion or leakage of a pump system, or the detection of presence of air in a pump would also be useful in many applications outside the medical field.
In many applications it is desirable to have an economical disposable pump system that is able to pump small quantities of liquid accurately, safely and reliably, in particular for single or limited use pump applications. Such applications may include for instance pumps of portable drug delivery systems such as insulin patch pumps, liquid dosing systems in laboratory or consumer applications, print cartridges, and many other applications.
An object of this invention is to provide a pump for that is accurate, reliable, compact, and economical to manufacture.
It would be advantageous to provide a micropump that is particularly cost effective to manufacture, such that it could be provided as a disposable system.
It would be advantageous to provide a pump with reliable means for detecting occlusion or leakage in the pump or downstream or upstream of the pump.
It is another object of this invention to provide a disposable micropump for medical applications that is economical, reliable and safe and that can deliver small quantities of liquid very accurately.
Objects of this invention have been achieved by providing a pump according to the present invention.
Other objects of this invention have been achieved by providing a method of detecting leakage or occlusion.
Disclosed herein is a pump comprising a housing, comprising a rotor chamber, inlet and outlet channels opening into the rotor chamber, and inlet and outlet seals mounted on a surface of the chamber, and a rotor rotatably and axially slidably received in the chamber and comprising a first axial extension comprising a liquid supply channel and a second axial extension comprising a liquid supply channel, the first and second axial extensions having different diameters. The inlet and outlet seals engage a surface of the rotor, whereby the liquid supply channel of each axial extension in conjunction with a corresponding seal forms a valve that opens and closes as a function of the angular and axial displacement of the rotor. At least one of the inlet and outlet channels opens transversely or radially into the rotor chamber and at least one of the inlet and outlet seals forms a closed circuit circumscribing said at least one of the inlet and outlet channels.
In an advantageous embodiment, both inlet and outlet channels open transversely into the rotor chamber and both inlet and outlet seals each forms a closed circuit circumscribing respective inlet and outlet channels. The surface circumscribed by either the inlet or the outlet seal preferably wraps around the corresponding rotor extension over an angle (α, β) less than 180°.
In an embodiment, the rotor is configured to oscillate over a rotation angle less than 360°, a back and forth movement constituting a pumping cycle.
In another embodiment, the rotor is configured to rotate in a single direction, a rotation angle of 360° constituting a pumping cycle.
The rotor and housing may comprise inter-engaging cam elements to effect the rotor axial displacement as a function of the rotation angle. In an advantageous variant, said cam elements comprising a double sided cam slot. The double sided cam slot may have a varying width in a variant configured to enable leakage or occlusion detection.
In the non oscillating variant, the axial displacement during pump filling may be defined by a cam section on one side of the cam slot, and the axial displacement during pump expelling defined by a cam section on an opposite side of the cam slot, the opposing cam surfaces acting as reference surfaces that accurately define the volume of pumped liquid at each cycle.
In an oscillating variant, the cam slot comprises a first portion defining the axial displacement in one rotation direction, and a second portion defining the axial displacement in an opposite rotation direction. At a transition position in the cam slot corresponding to a change in direction of rotation, the cam slot may advantageously comprises a step down or a point of no return configured to ensure that a complementary cam finger progresses from one cam slot portion to the other cam slot portion.
Also disclosed herein is a method of detecting occlusion or leakage of a pump, including the steps of performing an initial measurement comprising turning the rotor in a forward pumping direction at least one revolution and storing the axial displacement as a function of rotation displacement profile in a look-up table as a cam profile, measuring the rotor axial displacement as a function of rotation displacement during subsequent pumping and comparing the measured rotor displacement with the stored cam profile.
Before the cam profile setting, the rotor may be rotated in a reverse direction until a cam shoulder abuts a complementary cam finger, thus setting a defined reference starting position.
In an advantageous variant, a back and forth displacement of the rotor may be effected over an angle less than 90° when both valves V1 and V2 are closed to detect leakage.
Also disclosed herein is a method of removing gas bubbles or detecting leakage in a pump comprising a housing portion and an axially and rotatably movable rotor portion mounted in the housing portion and having an inlet valve (V1) and an outlet valve (V2), the method including applying a back and forth displacement of the rotor over an angle less than 180° while applying an axial force on the rotor. The back and forth displacement of the rotor occurs when both valves (V1, V2) are closed, preferably over an angle less than 90°.
A pump disclosed herein may in particular be adapted for medical applications, including for the administration of liquid medicaments.
Further objects and advantageous aspects of the invention will be apparent from the claims and the following detailed description of an embodiment of the invention in conjunction with the drawings in which:
a is a cross-sectional view of a pump module according to an embodiment of the invention;
b and 1c are exploded perspective views of the module of
d is a cross-sectional view through line 1d-1d of
a to 4f are perspective views of a rotor and housing of a pump module according to an embodiment of the invention, the housing being shown as partially transparent in order to better view the rotor therein, the different views 4a to 4f illustrating different rotational and axial position of the rotor relative to the housing to illustrate the pumping function of this embodiment, which relates to a rotor that rotates less than a full 360° in one direction or the other in an oscillating movement;
a to 5f are illustrations similar to
a is a graph illustrating the axial displacement (stroke) of the pump rotor as a function of the angular displacement of the rotor for a normal operating condition;
b is a graph similar to
c is a graph similar to
d is a graph similar to
e is graph similar to
f is a graph similar to
a-12e are graphs illustrating the axial displacement of an oscillating pump rotor with a double sided variable slot width cam according to an embodiment of the invention that allows detection of leakage or occlusion, where
Referring to the figures, in particular
Within the scope of the invention, the pump may be configured such that the inlet and outlet channels described herein are inversed, namely that the inlet opens into the larger diameter first chamber portion and the outlet opens into the smaller diameter second chamber portion. In other words, the pump may be configured to pump liquid from the large diameter portion towards the small diameter portion, or inversely may be configured to pump liquid from the small diameter portion towards the large diameter portion. For simplicity, only one of the variants is described in detail herein, however it is understood that using the same functioning principle, the pump may be configured according to the other variant.
The housing further comprises an inlet seal 20 surrounding the inlet channel 26 and mounted on a surface 29 of the chamber portion into which the inlet channel opens, and an outlet seal 18 surrounding the outlet channel 28 and mounted on a surface 27 of the chamber portion into which the outlet channel opens. The inlet seal 20 forms a closed circuit circumscribing the inlet 26 and the outlet seal 18 forms a closed circuit circumscribing the outlet 28. The outlet and inlet seals are configured to sealingly engage respective surfaces 31, 33 of corresponding first and second axial extensions of the rotor. The surface circumscribed by either the inlet or the outlet seal wraps around the corresponding rotor extension over an angle (α, β) that is preferably less than 180°.
Liquid supply channels 22, 24 are provided in the first and second axial extensions of the rotor.
According to an embodiment, as illustrated in
In another embodiment, as illustrated in
The liquid supply channels 22, 24 and seals 18, 20, are configured to form an outlet valve V2 and an inlet valve V1 that open and close the outlet and inlet channels as a function of the rotor axial and angular position relative the housing. The inlet and outlet channels in the housing do not need to be aligned as illustrated but may be positioned relative to each other at any angle around the rotor, the liquid supply channels in the rotor extensions being positioned accordingly. It is understood that the shape, position and size of the seals and the shape, position and size of the liquid supply channels may vary considerably without departing from the scope of the invention, the essential function being to open and close the valves and to avoid both valves being open simultaneously.
The inlet and outlet seals 20, 18 may be formed as separate elements assembled in the housing, or as elements formed integrally with the housing, for instance injection molded in the housing. The seals may for instance be injected from silicone-based or thermoplastic elastomers or rubber in a two-component single injection molding process with the housing.
Sealing rings 41, 43 may be provided around first and second extensions of the rotor on outer sides of the inlet and outlet valves in order to seal the liquid filling part of the rotor chamber 23. These sealing rings may be in the form of O-ring seals or other seals mounted or injected in the housing or on the rotor.
The rotor 6 may be driven by any appropriate motor (not shown). For instance, the rotor may comprise a motor portion (not shown) with one or more permanent magnets providing one or more magnetic poles, driven in rotation by electromagnets in a motor stator portion (not shown). The motor stator portion may either be part of the pump, or part of a separate base unit into which the pump module is removably mounted. The base unit can be provided with electronics for controlling and operating the pump and/or for transmitting signals to a control unit via a wireless or wired link. The base unit may be configured as a reusable unit to which the pump module is removably mounted such that the pump module may be disposed of and replaced.
The axial displacement of the rotor may be performed by a magnetic or electromagnetic drive, or by a magnetic or spring biasing force combined with a cam system. A single sided cam system 35, 37 on the rotor 6 and housing 4 in conjunction with a spring or a magnetic biasing force BF is known per se in the prior art and illustrated in
The axial displacement of the rotor may also be effected by means of a double-sided cam, according to an advantageous aspect of an embodiment of the invention, as illustrated in
The cam slot may comprise a single slot extending fully around the rotor for the embodiment where the rotor rotates 360° for the pumping action (embodiment of
The opposing cam surfaces 40a, 40b, 40a′, 40b′, 40a″, 40b″ of the cam slot 38, 38′, 38″ may either define a slot of essentially constant width (
In the embodiment with an oscillating rotor illustrated in
Referring now to
It may be noted that the rotor may be rotated in the reverse direction to pump liquid in the reverse direction (the inlet becomes the outlet and vice versa), the axial displacement cam being configured accordingly to allow rotation in both directions.
Referring to the embodiment of
The axial movement of the oscillating pump illustrated in
Referring now to
In section S1, no axial displacement takes place and the pump is neither filling nor emptying. Just before or as the cam protrusion on the housing meets the ramp CP2 of the rotor cam profile, the pump inlet valve V1 opens and the rotor is axially displaced along cam section S2 to draw liquid into the pump chamber up to the maximum axial displacement position defined by the cam portion CP3 after which the inlet valve closes and the rotor follows the flat path of section S3a along the cam portion CP3 until the cam finger on the housing moves past the cam profile section CP4. Along section S3b after the cam dropdown CP4, there is essentially no axial displacement since the liquid therein is essentially incompressible. There is however an inherent elasticity in the materials surrounding and containing the liquid in the pump, in particular in the seals which are elastic, such that there is a slight axial displacement step S3b as illustrated. Even though the cam profile abruptly changes at CP4 to the minimum value CP5 the rotor axial position does not change (except for the slight step) until the outlet valve opens allowing liquid to be expelled from the pump chamber.
In a variant of the invention where the cam ramp dropdown (CP4 to CP5) is essentially simultaneous with the valve V2 opening, occlusion detection is possible, however leakage detection is limited.
As the pump chamber empties, the axial displacement of the rotor follows the section S4 down to the minimum value defined by the cam profile CP5 to follow section S5 (which then rejoins S1 for further cycles). It should be noted that in order to keep the cam elements of the rotor and housing engaged, an axial biasing force is applied on the rotor relative to the housing. In typical embodiments, the axial biasing force may be applied magnetically and/or by means of a preloaded spring (not shown).
In the case of a leakage in the pump chamber, for example due to a defective seal, the rotor displacement may be detected since the rotor will displace axially in the zone Z1 before the outlet valve is opened and the ramp S4′ as illustrated in
Leakage in the pump chamber may also be detected by effecting a back and forth displacement of the rotor after the ramp dropdown section CP4 in the section (zone Z1) where both valves V1 and V2 are closed as illustrated in
A back and forth rotation of the rotor while an axial force is applied to the rotor may also be effected to dislodge gas bubbles in the pump chamber, especially during the priming operation. Preferably, the wobbling is performed at a position where the cam finger is over the ramp section CP2, such that the rotor performs a rotational and axial back and forth movement to dislodge bubbles stuck to the pump chamber walls. In a variant, gas bubbles may be dislodged by rotating the rotor in a reverse direction until the cam finger hits the stop CP4 to create a mechanical shock (deceleration). A back and forth rotation may be effected two or more times with the housing cam hitting the stop CP4 at each reverse rotation to create a plurality of successive shocks to dislodge gas bubbles. The rotor may then effect one, two or more turns to evacuate the gas bubbles after the wobbling operation.
The bubble dislodging operation may be effected in the priming operation, but may also be effected at any time during the operation of the pump, at regular intervals or for example after a malfunction detection, in particular to distinguish between a malfunction due to leakage or the presence of gas in the pump. In effect, a rotor displacement according to
As illustrated in
In the case of partial occlusion, for example in the case of impurities, a pinched outlet pipe, a blood clot and the like, the downstream pressure at the outlet will increase and cause the axial displacement S4′″ of the rotor to be more gradual as illustrated in
The occlusion and leakage detection methods described above may be applied in the same manner as described above in an embodiment with an oscillating pump as illustrated in
Each of the displacement profiles may be compared to an expected or defined reference profile S4, S5 as shown in
Referring to
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0376/10 | Mar 2010 | CH | national |
Filing Document | Filing Date | Country | Kind | 371c Date |
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PCT/IB2011/051071 | 3/15/2011 | WO | 00 | 9/14/2012 |
Publishing Document | Publishing Date | Country | Kind |
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WO2011/114285 | 9/22/2011 | WO | A |
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Entry |
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Written Opinion in International Application No. PCT/IB2011/051071, Oct. 10, 2011, pp. 1-13. |
Number | Date | Country | |
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20130017099 A1 | Jan 2013 | US |