Patent Application
20160271324
The present invention is related to medical pumps, more specifically to reservoirs used with insulin pumps and means to prevent and detect any over or under pressure in the reservoir.
Some insulin pumps, such as the one illustrated on
The implementation of an additional anti-free-flow valve is a possible way to overcome this problem. See WO 2008/029051. However, this may be expensive for a disposable product and may not be totally fail safe.
The present invention provides another advantageous solutions to prevent an over or under delivery of fluid to the patient (for example: insulin) which is induced when the pressure gradient between the reservoir and the external environment changes. Furthermore, the present invention may advantageously use with a method described in the application EP 11172494.4.
To this effect, it relates to a medical pump comprising three distinct chambers. Said medical device is designed to form a hard housing comprising a top and bottom hard shells. Said housing further comprises a hard wall and a movable membrane which create said three distinct chambers. Said movable membrane tightly separates the second and the third chambers. The first and third chambers have a watertight interface. Said second chamber is designed to contain a fluid. Said movable membrane may be moved between said rigid wall and the bottom hard shell, in such a way that the fluid tight reservoir is formed by the second chamber. Said first chamber comprises a first venting mean which is arranged to provide a fluidic communication between said first chamber and the external environment. Said third chamber comprises a second venting mean which is arranged to provide a fluidic communication between said third chamber and the external environment. The device further comprises a pumping element located in the first chamber, at least one pressure sensor which measures the pressure gradient between the first chamber and the third chamber. Said medical device comprises a fluid pathway which permits a first fluid connection between said second chamber and said pumping element and a second fluid connection between said pumping element and a patient line.
With the present invention, the third chamber is completely vented by said second venting mean while maintaining the protection against mechanical forces or ingress of solid foreign objects such as sharp tips. In one of embodiment, said second venting mean is formed by several passages. The protection against water ingress is not insured for the third chamber, which is not necessary If said movable member is a tight membrane. While, the first chamber is vented by a vent which may be hydrophobic and or oleophobic to protect the electronic part.
In one of embodiment, said movable membrane may transmit the pressure of the third chamber to said first fluid connection via the second chamber and the movable membrane. If, one or the both venting means get clogged, the pressure in the device and the pressure of the external environment may be different. The pressure gradient between inside device, in particular in the third chamber, and the external environment may induce an over or under delivery of the fluid to the patient.
For this reason, the second venting mean comprises several passages (which reduce the clogging risk) and the device uses a method partially described in the application EP 11172494.4 for detecting if at least one venting means is clogged.
The sensors may be localised in said chambers, in said fluid connections and/or outside.
The sensor may be a gauge pressure sensor localised between:
The reference port of said gauge pressure sensors may be the external environment, the first chamber or the third chamber.
In one of embodiment, the device comprises processing means for the sensor signal which may measure the pressure gradient between the third chamber and the first chamber or the external environment. And said processing means detect a under or over pressure in said first chamber and/or said third chamber.
Said processing means can detect the clogging of said first venting mean and/or said second venting mean.
The medical pump comprises alarm means which alert the patient in case of said first venting mean and/or said second venting mean are clogged.
The medical pump of the present invention comprises three distinct chambers (23, 29, 22). The second chamber (29) and the third chamber (22) is separated by a movable membrane (2) which may be moved between a bottom hard shell (1) and the rigid wall (3) and comprises an upper face (8), a lower face (9) and a lateral face (10). Said bottom shell (1) contains several holes (5) which are forming the internal ends of passages (7) communicating between the third chamber and the external environment.
The first chamber (23) is defined between the top hard shell (24) and the rigid wall (3). Said first chamber (23) comprises an upper face (25), a lower face (26), a pumping element (4) and a first venting mean (20).
The third chamber and the first chamber are tightly separated by at least said rigid wall (3) which is designed to form a watertight interface.
In one of said embodiments, a hydrophobic surface treatment or coating can also be used on and/or around the holes (5) to limit the water ingress.
In one of said embodiments, said first chamber (23) comprises the electronic elements.
In one of said embodiments, the lateral faces of said chambers are formed by the junction between part of the top and the bottom hard shell of the medical device.
The medical device comprises a first fluid connection (27) between said second chamber (29) and said pumping element, and a second fluid connection (28) between said pumping element and the patient line.
A sensor may measure a pressure gradient between the fluid and said first chamber (23) and/or said third chamber (22) or between said both chambers. Said sensor can be located upstream and/or downstream of the pumping element (4).
In a preferred embodiment, the sensor is a gauge pressure sensor. The reference port of said gauge pressure sensor is connected to said first chamber (23), allowing the detection of under or over pressure between:
In case of one or both of said venting means are clogged, a positive or negative pressure may be trapped in the third chamber (22) and/or in the first chamber (23).
Therefore, the device further comprises alarm means which can alert the patient if the first venting mean (20) of the first chamber or/and the second venting mean (7) of said third chamber (22) are clogged.
Vent Clogging Case Studies:
In a preferred embodiment, the change of pressure due to clogging can be monitored using two gauge sensors located in the pumping element. A first gauge pressure sensor is located in the first fluid connection (27) which may measure the pressure of the third chamber which is transmitted to the second chamber (29) (and the first fluid connection (27)) via the movable membrane (2). A second gauge pressure sensor is located in the second fluid connection (28) which may measure the pressure of the patient line. For both sensors, the reference port is the first chamber (23).
1. Clogging of the second venting mean (7) only→potential over or under pressure in the third chamber (22) is transmitted to the fluid in the second chamber (29) via the membrane (2) and is detected via the first sensor since the reference port (the first chamber (23)) of said sensor is not pressurized. The first sensor detects a pressure gradient between the third chamber (22) and the first chamber (23) while the second sensor doesn't detect any pressure gradient between the patient line and the first chamber (23).
2. Clogging of the first venting mean (20) only→the first chamber (23) and therefore the reference ports of both sensors shall potentially exhibit over or under pressure with respect to external environment. Said over or under pressure will be detected by both sensors. Positive (respectively negative) pressure in said first chamber (23) leads to a pressure signal equivalent to a negative (resp. positive) pressure in the pumping chamber in normal conditions. Therefore, a clogging of said first venting mean (20) is detected when the pressure in the first chamber (23) becomes different from external environment pressure. Said difference of pressure inducing the same offset on both gauge pressure sensors with respect to a reference value obtained either by measuring the pressure sensor signal before the priming of the pump or by using calibration data.
3. Clogging of all venting ports→the first and third chambers (23, 22) are potentially in over or under pressure with respect to the external environment. Therefore, the first sensor can't detect any pressure gradient between the first and the second or third chambers. But, the patient line pressure may be different. Therefore, the second sensor can detect a pressure gradient between the first chamber (23) and the patient line.
In a preferred embodiment, said holes (5) are oriented in a direction which is forming an angle above 30° with the main direction of their respective passages (7).
In the present invention the design of the bottom shell and more particularly the second venting mean (7) are driven by:
When second venting means (7), which is several passages like holes (5), are provided in the bottom shell (1) it is not possible to accidentally close all openings because of their specific locations. The compression of the pump against a soft material on the top shell cannot typically obstruct these passages because of their lateral orientated location. The closure of the passages by lateral compression is also prevented by baffles (6) that limit the access typically to fingers.
The passages (7) may have the shape of a slit or any other shape having one dimension preferably lower than 1 mm.
The passages (7) may also be made into a recess and oriented perpendicularly to the normal of the lateral face (10) of the third chamber (22) in order to prevent the insertion of a straight and rigid tip, the minimum dimension of the opening being preferably no longer limited to 1 mm in this configuration according to this recess.
The bottom shell (1) is preferably transparent; the patient should be able to see any large obstruction due to foods or any sticky stuff and eventually to change the disposable.
The bottom shell (1) and/or the rigid wall (3) and/or the membrane (2) are preferably made in plastic, and more generally in any material having specific grades compatible with insulin. The use of the same material is desirable for thermowelding. The contact surfaces for gluing or thermowelding between the top and bottom shell should be large enough to withstand reservoir overpressure up to 1 bar and drop test from a height of 1 meter or more.
The membrane material has ideally a low elasticity and a low permeability. The membrane thickness is typically smaller than 100 microns.
The surface of the membrane (2) is ideally larger than the surface of the lower face (9) of the third chamber (22) of the bottom shell to prevent any in-plane stress in the membrane and therefore any effect due to the membrane elasticity.
The bottom shell (1) can advantageously include Moiré pattern. In case of overfilling of the reservoir, when the membrane is directly in contact with the bottom shell, the reservoir pressure would bend the bottom shell and induce changes in the Moiré pattern, giving a visual feedback of overfilling to the patient. The Moiré pattern covers partly the bottom shell (1) surface in order to make possible the observation of bubbles into the reservoir.
The bottom shell may include any means to detect deformation due to static load or a pressurized reservoir (e.g. strain gauges, pressure sensors . . . ).
The passages (7) may be partly or completely covered by a removable and permeable tape that ensures the venting of the reservoir. In case of projection of sticky stuff on the passages (7) the patient can advantageously remove the tape instead of trying to clean up the device or simply changing it. The tape may be made of several sheets that can be removed iteratively. Such air permeable tape may also cover the first venting mean (20) of the first chamber (23).
The bottom shell (1) may include marks (11) that help the patient to find the filling port (12) containing a septum.
The bottom shell (1) is ideally flat and has lateral slides (13) for patch insertion (clipping) and grips (14) for patch removal (unclipping).
Fluid, e.g. water, can flow through the passages (7) and then in the space between the bottom shell (1) and the membrane (2), the fluid tightness being only provided to the first chamber (23) of the pump which, among other elements, includes the battery (16). The electronic and pump controller are in the first chamber which is water tight but has to be vented in case a zinc-air battery needing oxygen and when a gauge pressure sensors are used. The first chamber (23) is tightly assembled using lock (21) or clips or any other means onto the upper face of the rigid wall (3), contacting electrically the pads of the pump via the spring contacts (18) of the Printed Circuit Board (PCB) (17).
The first chamber (23) uses the first venting mean (20) which is therefore preferably hydrophobic and/or oleophobic.
In another embodiment (
In another embodiment, the device further comprises three distinct venting means. The first venting mean connects directly the first chamber to the external environment, the second venting mean connects directly the third chamber to the external environment and the third venting mean is located between the third and the first chamber. This embodiment insure a good venting in third and first chambers even if one venting mean is clogged. Said third venting mean is preferably hydrophobic and/or oleophobic.
| Number | Date | Country | Kind |
|---|---|---|---|
| 11171155.2 | Jun 2011 | EP | regional |
| 11172494.4 | Jul 2011 | EP | regional |
| Number | Date | Country | |
|---|---|---|---|
| Parent | 14128959 | Dec 2013 | US |
| Child | 15062086 | US |
