The present invention relates to infusion pumps and cassettes removably loadable therein.
Programmable infusion pumps are used to carry out controlled delivery of liquid food for enteral feeding and liquid medications for various purposes such as pain management. In a common arrangement, an infusion pump receives a disposable administration set comprising flexible tubing through which an infusion liquid is pumped. The administration set may comprise a cassette through which a resiliently deformable tubing segment extends, wherein the tubing segment has an upstream inflow end connected to tubing coming from a supply source of the infusion liquid and a downstream outflow end connected to tubing that leads to a patient. The resiliently deformable tubing segment is designed to be engaged by a pumping mechanism of the infusion pump. The cassette is removably loadable in the pump in a predetermined position in which the tubing segment is placed near the pumping mechanism to enable the pumping mechanism to act upon the tubing segment to drive liquid flow through the tubing.
As a safety feature to protect the patient, it is known to provide a free-flow protection device as part of the administration set to automatically stop flow of infusion liquid through the tubing if the cassette is not properly loaded in the pump. Free-flow protection devices of the prior art have various forms, including spring-biased pinch clamps, slide clamps, and in-line occluders. When the cassette is properly loaded in the pump, the free-flow protection device is disabled and typically sits idle until needed.
Spring-biased pinch clamps provide reliable free-flow protection, and have advantages over in-line occluders and slide clamps. Unlike in-line occluders, which have a stop valve within the lumen of the tubing segment, spring-biased pinch clamps do not interfere with the flow of thicker nutritional liquids. Unlike slide clamps, which require application of an external force to move the slide clamp from an open position to a closed position, spring-biased pinch clamps are biased to automatically assume a closed position in the absence of an external force needed to open the pinch clamp. Despite these advantages, spring-biased pinch clamps have the drawback that they are mechanically complex to manufacture and assemble. A spring-biased pinch clamp may have three parts: a main body, a separate plunger movable with respect to the main body, and a spring element for biasing the plunger relative to the main body. These parts are manufactured separately and must then be assembled, thereby adding cost to the cassette.
The present disclosure provides a cassette for use with an infusion pump. The cassette may generally comprise a monolithic cassette body and a segment of resiliently deformable tubing mounted to the cassette body for conveying a flow of liquid. The monolithic cassette body may include a fixed pinch element, and a deflectable pinch arm having a movable pinch element. The pinch arm may normally reside in a closed position in which the movable pinch element cooperates with the fixed pinch element to deform the tubing segment to stop the flow of liquid. The pinch arm may be resiliently deflectable away from the closed position to an open position in which the movable pinch element is positioned relative to the fixed pinch element such that the flow of liquid is permitted, wherein deflection of the pinch arm away from the closed position spring biases the pinch arm toward the closed position. Thus, the monolithic cassette body has an integrally formed free-flow protection device.
In an aspect of the disclosure, the cassette body may include a platen surface, and deflection of the pinch arm from the closed position to the open position may displace the movable pinch element in a lateral direction relative to the platen surface and the tubing segment. In one embodiment, the platen surface may be convex, for example trapezoidal.
In another aspect of the disclosure, the cassette body may include a wall having an opening therethrough, the pinch arm may have a first portion cantilevered outwardly from the wall to extend away from the tubing segment and a second portion arranged to extend inwardly through the opening, and the movable pinch element may be located on the second portion of the pinch arm. The pinch arm may be deflectable away from the closed position by forcing the first portion of the pinch arm toward the wall.
In another aspect of the disclosure, the cassette may further comprise a spring received by the cassette body, wherein the spring additionally spring biases the pinch arm toward the closed position when the pinch arm is deflected away from the closed position. In one embodiment, the spring may be a leaf spring. The leaf spring may include a proximal end and a distal end, and the cassette body may include a first slot adjacent the wall and a second slot adjacent the pinch arm, wherein the first and second slots respectively receive the proximal and distal ends of the leaf spring.
The disclosure also provides fluid delivery system comprising a pump in combination with a cassette as summarized above. The pump may comprise a cassette interface and a pump door movable relative to the cassette interface between a loading position and a pumping position. When the cassette is received by the cassette interface of the pump, movement of the pump door from the loading position to the pumping position may cause the pump door to deflect the pinch arm from the closed position to the open position, and subsequent movement of the pump door from the pumping position to the loading position may cause the pinch arm to automatically return from the open position to the closed position.
The nature and mode of operation of the present invention will now be more fully described in the following detailed description taken with the accompanying drawing figures, in which:
As shown in
Cassette 34 of the present embodiment is now described with reference to
Monolithic cassette body 36 comprises a free-flow protection device integrally formed as part of the monolithic cassette body. In the depicted embodiment, the free-flow-protection device includes a fixed pinch element 38 and a pinch arm 40 having a movable pinch element 42. Pinch arm 40 normally resides in a closed position illustrated in
Cassette body 36 may include a platen surface 44 extending adjacent to at least a portion of tubing segment 32A. Platen surface 44 may or may not be flat (i.e. planar). As best seen in
Deflection of pinch arm 40 between the closed position (
Cassette body may include a wall 46 having an opening 48 therethough. Pinch arm 40 may have a first portion 40A cantilevered outwardly from wall 46 to extend away from tubing segment 32A and a second portion 40B arranged to extend inwardly from a distal end of first portion 40A toward tubing segment 32A, wherein second portion 40B passes through opening 48 in wall 46. Movable pinch element 42 may be located on second portion 40B of pinch arm 40. In the embodiment shown in
Movable pinch element 42 may include a movable pinch edge 42A and the fixed pinch element 38 may include a fixed pinch edge 38A, wherein the movable pinch edge and fixed pinch edge contact tubing segment 32A on opposite lateral sides of the tubing segment. The fixed pinch edge 38A and movable pinch edge 42A may be arranged to contact tubing segment 32A directly across from one another at an axial pinch location P along the tubing segment, as shown in
Cassette body 36 may include at least one grip 50 for holding tubing segment 32A adjacent to platen surface 44. For example, first and second grips 50 may be arranged near opposite ends of the platen surface 44, respectively.
Cassette body 36 may be molded or additively manufactured, for example by three-dimensional printing, as a monolithic plastic part. By way of non-limiting example, cassette body 36 may be molded from a polycarbonate or TRITAN™ brand plastic. As will be appreciated from the foregoing description, monolithic cassette body 36 includes an integrally formed free-flow protection device.
As an option, cassette 34 may further comprise a spring 52 received by cassette body 36 for providing additional spring biasing of pinch arm 40 toward the closed position when the pinch arm is deflected away from the closed position. In one embodiment, spring 52 is a leaf spring which includes a proximal end 53 and a distal end 55, and cassette body 36 includes a first slot 37 adjacent wall 46 and a second slot 39 adjacent pinch arm 40, wherein first slot 37 receives proximal end 53 of leaf spring 52 and second slot 39 receives distal end 55 of the leaf spring. According to the illustrated embodiment, second slot 39 may receive distal end 55 of leaf spring 52 with clearance between the distal end of the leaf spring and an end of the slot. First slot 37 may be proximate a cantilever location where first portion 40A of pinch arm 40 merges with wall 46.
While spring 52 is shown in one embodiment as being a leaf spring, spring 52 may be a different type of spring, for example a coil spring or a torsion spring.
Loading of cassette 34 into infusion pump 10 to provide a safe fluid delivery system will now be described with reference to
Door 62 may include a cam surface 64 configured to engage pinch arm 40 as door 62 is moved from the loading position to the pumping position, as indicated by the arrow in
In the illustrated embodiment, pump door 62 has a hinge axis 65 about which the pump door pivots between the loading position and the pumping position, and deflection of pinch arm 40 from the closed position to the open position is in a direction toward hinge axis 65. Instead of a hinged door, a sliding door may be used and configured such that sliding the door from its loading position to its pumping position will deflect pinch arm from its closed position to its open position.
While the present disclosure describes exemplary embodiments, the detailed description is not intended to limit the scope of the appended claims to the particular embodiments set forth. The claims are intended to cover such alternatives, modifications and equivalents of the described embodiments as may be included within the scope of the claims.
Number | Name | Date | Kind |
---|---|---|---|
3918854 | Catarious et al. | Nov 1975 | A |
4537561 | Xanthopoulos | Aug 1985 | A |
4689043 | Bisha | Aug 1987 | A |
4944485 | Daoud | Jul 1990 | A |
5330431 | Herskowitz | Jul 1994 | A |
5401256 | Stone et al. | Mar 1995 | A |
5620312 | Hyman | Apr 1997 | A |
D389228 | Winterer et al. | Jan 1998 | S |
5704584 | Winterer et al. | Jan 1998 | A |
5954485 | Johnson et al. | Sep 1999 | A |
6203528 | Deckert et al. | Mar 2001 | B1 |
8551057 | Gagliardoni et al. | Oct 2013 | B2 |
8920144 | Rotem et al. | Dec 2014 | B2 |
8986252 | Cummings et al. | Mar 2015 | B2 |
9017297 | Travis | Apr 2015 | B2 |
9333290 | Rotem | May 2016 | B2 |
9581152 | Rotem et al. | Feb 2017 | B2 |
9616170 | Nakanishi | Apr 2017 | B2 |
20030040700 | Hickle et al. | Feb 2003 | A1 |
20040094147 | Schyra et al. | May 2004 | A1 |
20050214146 | Corwin et al. | Sep 2005 | A1 |
20070265559 | Kunishige | Nov 2007 | A1 |
20090221964 | Rotem | Sep 2009 | A1 |
20100036322 | Rotem | Feb 2010 | A1 |
20100082001 | Beck | Apr 2010 | A1 |
20110313358 | Hariharesan et al. | Dec 2011 | A1 |
20120083737 | Beck | Apr 2012 | A1 |
20120136305 | Gagliardoni et al. | May 2012 | A1 |
20120213646 | Shipman | Aug 2012 | A1 |
20120266965 | Hariharesan et al. | Oct 2012 | A1 |
20130267899 | Robert et al. | Oct 2013 | A1 |
20140276424 | Davis et al. | Sep 2014 | A1 |
20150285404 | Koyama et al. | Oct 2015 | A1 |
Number | Date | Country |
---|---|---|
1557187 | Jul 2005 | EP |
3133453 | Jul 2007 | JP |
WO-2010023913 | Mar 2010 | WO |
2010101783 | Sep 2010 | WO |
2014184986 | Nov 2014 | WO |
Number | Date | Country | |
---|---|---|---|
20210023297 A1 | Jan 2021 | US |