Patent Grant
8777590
The present invention relates to a means of loading and unloading a pump cassette or other fluid delivery device into a medical pump.
Modern medical care often involves the use of medical pump devices to deliver fluids and/or fluid medicine to patients. Medical pumps permit the controlled delivery of fluids to a patient, and such pumps have largely replaced gravity flow systems, primarily due to the pump's much greater accuracy in delivery rates and dosages, and due to the possibility for flexible yet controlled delivery schedules. Of the modern medical pumps, those incorporating a diaphragm cassette are often preferred because they provide more accurately controlled rate and volume than do other types of pumps.
A typical positive displacement pump system includes a pump device driver and a fluid delivery device, including but not limited to a syringe, tubing, section of tubing, or a disposable cassette. The disposable cassette, which is adapted to be used only for a single patient and for one fluid delivery cycle, is typically a small plastic unit having an inlet and an outlet respectively connected through flexible tubing to a fluid supply container and to the patient receiving the fluid. The cassette includes a pumping chamber, with the flow of fluid through the chamber being controlled by a plunger or plunger activated in a controlled manner by the device driver.
One of the requirements for many pumps, including cassette pumps, is that they are able to dictate the stability and proper positioning of the fluid delivery device or cassette when loaded. The stability and proper positioning of the cassette is critical to ensure that any pump elements (including the plunger and/or sensors) that interact with the cassette are precisely aligned and positioned to accurately produce the desired output of the cassette or sense conditions related to the pump.
Previous pumps attempted to accomplish the proper positioning of the cassette by providing a molded seat that a user would manually push the cassette into. Once the cassette is forced into the molded seat, retentive snap elements engage the outer surface of the cassette to hold the cassette within the molded seat.
These previous pumps often have few if any physical elements to ensure proper cassette orientation to the pump. They rely heavily on proper loading by the operator to insure complete seating of the cassette to the pump. Additionally, they may often lack means for monitoring if the cassette was indeed oriented correctly and/or fully seated to the pump.
Other previous pumps have attempted to provide automatic cassette loaders that utilize sensors and alarms when improper cassettes are placed in the loader and to detect when the loader is not fully opened or closed. Specifically, as seen in U.S. Pat. No. 7,258,534 a processing unit is utilized in order to drive a linear actuator to position a carriage to load and unload a cassette. While effective at providing a loader that does not accept inaccurately sized cassettes, ensuring that the cassette loader is fully opened for loading, and providing an alarm if the loader is jammed or not fully closed, problems remain. Such a design is very complex, expensive, has increased maintenance issues, and can be difficult to use.
Therefore, a principal object of this invention is to provide a cost-effective medical pump having a manual loading system that provides clear, stable and proper positioning of the fluid delivery device.
A further object of the invention is to provide a medical pump that monitors proper fluid delivery device loading.
A further object of the invention is to provide a medical pump with a fluid delivery device loading system that is essentially bi-stable and thereby prevents dwelling, parking or inadvertent positioning of the fluid delivery device loading system in any position other than fully open or fully closed.
Another object of the invention is to provide a medical pump having a manual release element for manually ejecting a fluid delivery device from the pump.
Another object of the invention is to provide a medical pump with a cassette loading system having reduced complexity and power requirements.
These and other objects will be apparent to those skilled in the art.
A medical pump includes a chassis having a fixed seat, and a carriage having a footing for receiving a fluid delivery device, including but not limited to a cassette, syringe and/or tubing, and restricting its movement. An actuator assembly moves the carriage between open and closed positions to engage the cassette or fluid delivery device to the seat. The seat establishes the position of both the carriage and fluid delivery device in the closed position.
The actuator assembly is connected to the carriage and includes a rack and pinion assembly that can be operated by rotation of a U-shaped body of the pinion assembly about a pivot axis manually with a handle or lever or otherwise. The rotation of the pinion assembly about the pivot axis causes a cam follower on the U-shaped body to move along the cam surface of a cam element mounted to the chassis. The cam surface is separated into first (upper or closing) and second (lower or opening) cam surfaces by a raised detent, apex or point of instability thereon. Thus, carriage is urged in a bi-stable manner into either a fully open position or a fully closed position. The cam element surface profile prevents dwelling of the carriage in any position other than fully open or fully closed when external force is withdrawn or withheld. One or more spring elements can interconnect the cam element or cam follower of pinion assembly with the chassis to obtain the desired carriage closing and opening force characteristics, as well as the force/torque requirements at the handle or lever. In one embodiment, a user can manually rotate the pinion assembly with an externally accessible handle to open and close the carriage.
With reference to
With reference to
An elastomeric membrane 32 forms a diaphragm that extends over a pumping chamber 38 located between the inlet 24 and outlet 26 on an inner face 40 of the main body 28.
In operation, fluid enters through the inlet 24 and is forced through outlet 26 under pressure. The fluid is delivered to the outlet 26 when the pump 10 displaces the pumping chamber 38 to expel the fluid. During the intake stroke the pump 10 releases the pumping chamber 38, and the fluid is then drawn through the inlet 24 and into the pumping chamber 38. In a pumping stroke, the pump 10 displaces the pumping chamber 38 to force the fluid contained therein through the outlet 26. Thus, the fluid flows from the cassette 22 in a series of spaced-apart pulses rather than in a continuous flow. The fluid is delivered to the patient at a pre-set rate, in a predetermined manner, and only for a particular pre-selected time or total dosage.
A flow stop 42 is formed as a switch in the main body 28 and protrudes from the inner surface 40. This protrusion forms an irregular portion of the inner surface 40 which can be used to align the cassette 22 as well as monitor the orientation of the cassette 22. The flow stop 42 provides a manual switch for closing and opening the cassette 22 to fluid flow when the cassette is not installed in the pump 10. Once the cassette 22 is properly loaded, seated or installed in the pump 10, the pump controls in a conventional manner the positioning of the flow stop 42 and thus the delivery of fluid through the cassette 22.
As best shown in
The actuator assembly 44 additionally has a carriage 56 that is connected to the chassis 46 and has an opening therein that is adapted to receive the cassette 22. The opening forms a footing that restricts movement of the cassette within the carriage 56. U.S. Pat. No. 7,258,534 that is incorporated in its entirety herein describes the carriage 56, the cassette receiving opening and footing in greater detail, how fascia 55 surrounds and is connected to the carriage 56 and slide plates, and explains how a cassette 22 is loaded into a carriage 56. As disclosed therein, the carriage 56 is movable inwardly with respect to the chassis 46 from an open position wherein the carriage 56 is spaced from a fixed seat 43 on the chassis 46 to a closed position to engage the cassette 22 to the fixed seat 43. The fixed seat 43 on the chassis 46 is formed by one or more finger elements 45 extending horizontally and outwardly from a vertical base surface located on the front of the chassis 46.
In operation the cassette 22 is inserted into a top opening of the front carriage assembly, when the loader 20 is in the open position. Upon insertion, the cassette 22 slides into the carriage 56 and is loosely secured in place and supported by the footing on the carriage. The carriage 56 is movable from an open position horizontally inwardly with respect to the chassis 46 to a closed position to engage the cassette 22 to the fixed seat 43.
In one embodiment of the present invention the actuator assembly 44 includes a rack element 57 connected to the carriage 56. The rack element 57 has a plurality of teeth 58 and optionally can include written indicia associated with the teeth 58 to indicate the position of the carriage 56 with respect to the chassis 46.
As best understood in view of
In one embodiment the mounting brackets 59, 59A, 59B extend between the side chassis members 47, 49 and a bearing plate 61, 63 that mounts to the side chassis members 47, 49 and includes the bearing 50. In such an embodiment, the brackets 59, 59A, 59B have an upper arm 34 and a lower arm 36 that define an opening 35 therebetween and extend from a central portion that is connected to the carriage 56. The opening 35 is sized and shaped so as to provide clearance that allows for the predetermined, anticipated or desired range of movement of the carriage 56 with respect to the chassis 46. Separate bearing plates 61, 63 and clearance in the rear of the chassis 46 and side chassis members 47, 49 allow assembly of most of the actuator assembly 44 after the carriage 56 is put in place and brought into engagement with the fixed seat on the chassis 46. In one embodiment guide members 65, 67 are mounted or formed on one or more of the side chassis members 47, 49 or the bearing plates 61, 63 to guide the mounting brackets 59, 59A, 59B during their movement with respect to the chassis 46. The use of a lower guide member 67 also provides a support surface on which the movable brackets 59, 59A, 59B can slide.
The actuator assembly 44 additionally includes a pinion assembly 62 that is best seen in
The actuator assembly 44 additionally comprises a cam element 80 as best shown in
As shown in FIGS. 3 and 8-13, the actuator assembly 44 has at least one spring element 92 that is used to bias the cam element 80 into engagement with the cam follower 72 and generally toward the carriage 56 that holds the cassette 22. In one embodiment (FIGS. 3 and 8-9) a tension spring is used and connected to the end of the cam element 80 opposite the opening 82 and attached at another end to the anchor 54 on the chassis 46 or to another location on the chassis 46 or actuator assembly 44. As shown in FIGS. 3 and 10-13, one way of connecting an end of the spring element 92 to an end of the cam element 80 is with the anchor 91, which in this particular embodiment is shown as a hook. Alternatively, in another embodiment shown in
In addition, more than one spring element 92 operatively connected to the cam element and working in concert or opposition with another may be used to provide biasing force and provide the desired open and closing force characteristics or torque requirements for the loader 20 or the handle 71. See
Because of the unique design of the actuator assembly 44, in the absence of any externally applied force, the actuator assembly 44 always presents a minimum clamping force of more than 7 lbs. to keep the carriage 56 in a closed or fully closed position and a force of about 1 lb. to keep the carriage 56 in an open or fully open position. Somewhere in the range of 5-10 lbs. of external force needs to be applied to overcome the biasing force of the actuator assembly 44 and move the carriage 56 from a nominally open position to the transition point where the cam follower 72 is at the detent 90. The force required gradually increases as the carriage 56 or the handle 71 is moved inwardly until the cam follower 72 reaches the detent 90 on the cam element 80. Once the detent 90 is traversed, the biasing force of the actuator assembly 44 switches from resistance to assistance and provides a clamping force that moves the carriage 56 to the closed position and maintains it there. In the closed position, the actuator assembly 44 clamps the carriage 56 closed so that the cassette 22 engages the fixed seat on the chassis 46. In this position, the initially closed flow stop 42 and the cassette 22 are under the control of the infuser mechanism 16 of the pump 10. The actuator assembly 44 stops or resists further movement of the carriage 56 at the opened and closed positions and prevents externally initiated movement from being stopped between the opened and closed positions. If the external forces are withdrawn during the inward movement of the loader 20 prior to the traversing of the detent 90, the loader 20 will be urged to return to the open position. If the external forces are withdrawn during the opening of the loader 20 prior to the traversing of the detent 90, the loader 20 is likewise urged to return to or stay in the closed position. Thus, the carriage 56 can only stop, rest or dwell in a fully opened or fully closed position, thereby ensuring that the carriage 56, and thus cassette 22, is not parked or left in a different position. In this manner the carriage 56 cannot be left in a position close to but not quite in the fully closed position wherein flow stop 42 might be inadvertently bumped open causing free flow to a patient without realization of a user. Instead, the carriage 56 can only be stopped in the fully open and fully closed positions such that an individual using the medical pump 10 does not use the medical pump at a time that the cassette 22 is not properly installed and positioned within the pump 10. The loading system also identifies and prevents an unauthorized or improper cassette from being loaded. An unauthorized, incorrect or improperly shaped cassette cannot be fully loaded because it will be physically blocked from reaching the fully closed position and thus the carriage 56 will return to the fully open position where the user will realize the error and remove the improper cassette.
In operation, with reference to
As an individual manually or otherwise moves the carriage 56 or rotates the lever 71, the cam follower 72 moves along the first arcuate surface 86 to the detent 90 to place the system in a neutral but unstable detent position. At the detent position the force from the cam element 80 is normal to the pivot axis 70 resulting in a balance with the other forces in the system that neither urges the teeth 68 of the pinion assembly 62 to pull or push on the teeth 58 of the carriage mounting brackets 59, 59A, 59B. Instead, because the force from the cam element 80 is normal to the axis, no inherent internal rotational force exists on the pinion assembly 62. However, because the detent 90 is formed as a raised apex, it is unlikely for the cam follower 72 to dwell there.
When the cam follower 72 moves to the second arcuate section 88 of the cam surface 84, as shown in
Once a cassette 22 is installed in the carriage 56 of the loader 20 the handle 71 is then rotated causing the cam follower 72 to move along the cam surface 84 from the second arcuate section 88 to the detent 90. Once the cam follower 72 overcomes the detent 90 and begins moving along the first arcuate section 86 of the cam element 80 the rotational force about axis 70 changes to a force urging the carriage 56 to the closed position. In this manner the actuator assembly 44 urges and holds the carriage 56 in the fully opened and fully closed positions and prevents the carriage from stopping at a position that is not either fully opened or fully closed.
Handle 71 is received within the bearing 50 of the infusion cover 18 of the housing 12 by a lever bearing 104. Lever bearing 104 similarly has a journal 106 that is centrally located and aligns with the journal 100 of the handle 71 such that a fastening member 108 is threadably received through the journal 106 by the journal 100 to secure the handle 71 to the lever bearing 104.
The lever bearing 104 has a rounded main body 110 that has aligned openings 112 separated by spokes 114. The openings 112 are spaced about the journal 106 and receive the engagement members 102 such that when the lever bearing 104 is secured to the handle 71 the engagement members 102 are within the openings 112. The openings 112 are of size and shape to have a greater circumference than the engagement members such that the engagement members 102 can rest within the openings 112 without engaging the lever bearing 104. In this manner the handle 71 is rotated from about 5 degrees to 10 degrees before engaging the spoke 114 of the lever bearing 104 in order to cause rotation of the lever bearing 104.
The lever bearing 104 additionally has a tongue element 116 extending from the main body 110 downwardly and forming a flange 118 that extends away from an arcuate section 120 of the tongue element 116 such that the flange 118 extends toward the interior of the housing 12. Finally, the tongue widens to a rounded end section 122 that angles downwardly from the flange 118. Attached to the end section 122 is a roller element 124 that is guided by a bearing element 126 in the interior of the housing 12. In the embodiment shown, the bearing element 126 is a raised rail formed arcuately on an interior surface of the cover 18 of the housing 12. The bearing element could also be an arcuate slot in the cover 18 that guides a pin on which the roller element 124 is mounted.
Additionally within the cover 18 of the housing 12 a spring element 128 having a coil 130 mounted on a hub element 132 secured to the housing 12. The spring element 128 additionally has first and second tang elements 134 and 136 where the first tang element engages a stop element 138 secured to the housing 12 and the second tang element 136 is an elongated member having a length longer than the first tang element 134 and received within a groove 123 (not shown) on the roller element 124 such that the roller element 124 is guided along the second tang 136 as the lever bearing 104 is rotated about the pivot axis 70.
In the embodiment of
When rotating the handle 71, the handle can be rotated from about 5-10 degrees before the arcuate flanges 142 engage the spokes 114 of the lever bearing 104. After this the lever bearing 104 continues to rotate such that the spokes 114 engage and rotate the arcuate flanges 142 of the pinion assembly 62. During the initial “lost motion” rotation of the handle 71, the second tang 136 resists the motion of the handle 71 as the roller element 124 moves along the tang 136. In this manner the handle 71 is not urged toward the opened position unless overcoming more than a mere nominal force on the lever that can be created as the result of cleaning the lever 71 and housing 12 during routine maintenance of the pump 10. As the pinion assembly 62 rotates the pinion assembly 62 interacts with the cam element 80 as discussed above in order to open and close the cassette loader 20 as required.
Thus, presented is a medical pump for use with a cassette. The device has an actuator assembly that is bi-stable and arranged so as to be actuated to place the assembly in only one of a fully opened or a fully closed position. By utilizing this arrangement a manual actuator can be utilized that prevents a carriage from being parked in a position that is not either fully opened or fully closed. This eliminates instances of mistake wherein a carriage is parked in a non-closed position yet an individual believes the carriage is closed and attempts to provide medicine with the infuser or pumping mechanism 16 of the pump 10. This also helps deter a user from inadvertently changing the position of the flow stop 42 on the cassette 22 during loading and unloading. In addition, the system is easy to use efficient and is more inexpensive to manufacture than automatic loaders for pumps. By only allowing a fully opened or fully closed position cassettes of only a certain predetermined size may be placed into the system to ensure that inaccurately sized cassettes that are incompatible with the medical pump are not placed into the medical pump. Thus, at the very least all of the stated objectives have been met.
It will be appreciated by those skilled in the art that other various modifications could be made to the device without departing from the scope of this invention. All such modifications and changes fall within the scope of the claims and are intended to be covered thereby.
This application claims the benefit of U.S. Provisional Application Ser. No. 61/426,348 filed Dec. 22, 2010, which is hereby incorporated in its entirety herein by reference.
| Number | Name | Date | Kind |
|---|---|---|---|
| 1576445 | Mitchell | Mar 1926 | A |
| 2903165 | Hanson et al. | Sep 1959 | A |
| 3427986 | Corneil | Feb 1969 | A |
| 3606596 | Edwards | Sep 1971 | A |
| 3777581 | Sartori | Dec 1973 | A |
| 4187057 | Xanthopoulos | Feb 1980 | A |
| 4513885 | Hogan | Apr 1985 | A |
| 4696671 | Epstein et al. | Sep 1987 | A |
| 4842584 | Pastrone | Jun 1989 | A |
| 4858548 | Echeverria | Aug 1989 | A |
| 5098262 | Wecker et al. | Mar 1992 | A |
| 5138743 | Hoffman | Aug 1992 | A |
| 5282787 | Wortich | Feb 1994 | A |
| 5462256 | Minick et al. | Oct 1995 | A |
| 5586868 | Lawless et al. | Dec 1996 | A |
| 5601420 | Warner et al. | Feb 1997 | A |
| 5647852 | Atkinson | Jul 1997 | A |
| 5673588 | Raymond | Oct 1997 | A |
| 5816779 | Lawless et al. | Oct 1998 | A |
| 5910808 | Fukasawa et al. | Jun 1999 | A |
| 6231320 | Lawless et al. | May 2001 | B1 |
| 6325264 | Omosako | Dec 2001 | B1 |
| 6595943 | Burbank | Jul 2003 | B1 |
| D504507 | Ziegler et al. | Apr 2005 | S |
| 7160087 | Fathallah et al. | Jan 2007 | B2 |
| 7258534 | Fathallah et al. | Aug 2007 | B2 |
| 8152486 | Fathallah et al. | Apr 2012 | B2 |
| 20050095152 | Dale | May 2005 | A1 |
| 20050214129 | Greene et al. | Sep 2005 | A1 |
| 20050260090 | Stark et al. | Nov 2005 | A1 |
| 20070058412 | Wang et al. | Mar 2007 | A1 |
| 20080038130 | Fathallah et al. | Feb 2008 | A1 |
| 20080145249 | Smisson et al. | Jun 2008 | A1 |
| 20100094224 | Fathallah et al. | Apr 2010 | A1 |
| Number | Date | Country | |
|---|---|---|---|
| 20120164006 A1 | Jun 2012 | US |
| Number | Date | Country | |
|---|---|---|---|
| 61426348 | Dec 2010 | US |
