The present disclosure is related to the field of intravenous (IV) infusion devices such as peristaltic pumps and the associated flexible IV tubing and other related devices. Specifically, the present disclosure relates to arrangements and methods for preventing free flow in an IV tube when the infusion pump is disengaged from the IV tube.
It is a common practice to deliver fluids such as medications to a patient intravenously by means of a pumping device, such as a peristaltic pump, a four-finger pump, a diaphragm pump or a constant displacement pump. Such pumps are useful because they can deliver the medication in a highly controlled and precise fashion, and because they do so without coming in contact with the medication. The fluid is moved through a flexible IV tube by pressing a pumping member against the tube sufficiently to move the fluid in the tube downstream towards the patient. In the case of peristaltic mechanisms having multiple pumping fingers, the fingers are moved against the tube in a sequential manner from upstream to downstream to sequentially occlude the tube thereby moving the fluid in the tube downstream towards the patient. When the IV tube is mounted correctly in the pump, the IV tube is at all times occluded by one of the pumping members, thereby preventing the “free flow” of fluid to the patient. “Free flow” of medical fluids is undesirable since the flow of the fluid is uncontrolled and the prescribed treatment is not followed.
It is common for the peristaltic pumping mechanism to be located in a housing with a hinged door. The tube through which the fluid is to be moved is placed in contact with the pumping mechanism inside the door, with the ends of the tubing typically extending out the top and bottom of the door opening. As the door is shut over the tube, a platen on the inside of the door presses against the IV tube to provide a backing surface against which the pumping members can occlude the tube. The platen is typically spring loaded, although not always, against the pumping mechanism so that one or more of the pumping fingers of the pumping mechanism occludes the tube once the door is shut over the tube. The tube occlusion prevents free flow while the door is shut.
This arrangement of the IV tube relative to the pumping mechanism requires that there be some means for preventing flow in the tube when the door of the pump is open. Merely opening the pump door would relieve the tube from the occluding pumping mechanism/platen combination and free flow could possibly occur. This could result in the uncontrolled infusion of medication into the patient under the influence of the static head pressure in the tube, or blood from the patient could flow back into the IV tube. Known devices for preventing the unwanted flow in the tube include manual clamps on the tube separate from the infusion pump, and automatic occluding devices mounted on the pump. The manual devices require some manipulation skill on the part of the attending technician, and there is always the chance that the technician will forget to properly initiate the manual clamping process of the tube before the door of the pump is opened. Furthermore, the door may be accidentally opened, resulting in free flow in the tube.
Automatic devices mounted on the infusion pump for assisting in clamping and unclamping infusion tubes have improved. In particular, the reliability in timing the occlusion and release (unocclusion) of the tube with the disengagement and engagement, respectively, of the tube with the pumping members has improved. Typically, the action of opening the door is relied upon to initiate the occlusion of the IV tube by a clamp, and the action of closing the door is relied upon to initiate the release or unocclusion of the tube by an IV tube clamp. However, there still can occur the possibility of an inadvertent free flow of fluid through the IV tube due to operator error in regard to use of such devices. The above need has been partly addressed in the prior art by providing a mechanism called “flow stop.”
In one aspect of the present disclosure, an improved anti-flow protection apparatus in needed.
The above-discussed and other needs for improved anti-flow protection devices and methods are disclosed.
In a first exemplary aspect, a mechanism for selectively preventing fluid flow through a resilient tube is disclosed. The mechanism comprises a base for holding the tube, a locking arm mounted on the base and having a moveable tab, a slide clamp, having a distal end and a proximate end, slidably mountable on the base for reciprocating movement in a sliding direction between an occluding position and an open position, the slide clamp having an aperture through which the tube extends when the tube is mounted within the mechanism, the aperture having a constricted region at which the tube is occluded when the tube is within the constricted region, and an expanded region at which the tube is not occluded when the tube is within the expanded region, and a flange at the distal end of the slide clamp and configured for interaction with an operator finger for pushing the slide clamp in a sliding direction toward the open position, the moveable tab being directly behind the flange in the sliding direction, the flange having a slip preventive feature preventing slippage of the operator finger from the flange at least in the sliding direction, wherein the locking arm locks the slide clamp in the occluding position until released by actuation of the moveable tab.
In a second exemplary aspect, A method of preventing fluid leakage from a tube during loading the tube in a pump, comprising the steps of passing the tube through an opening in a slide clamp, the slide clamp provided for occluding the tube when the slide clamp is in an occluding position and allowing passage of fluid through the tube when the slide clamp is in an open position, the slide clamp being slideable in a sliding direction between the occluding position and the open position, the slide clamp comprising a release tab in the sliding direction with respect to a flange coupled to the slide clamp, pushing, with an operator's finger, on the flange in the sliding direction to seat the slide clamp in the pump, and preventing inadvertent slippage of the operator's finger in the sliding direction with a slip prevention feature on the flange, wherein the release tab is configured to deactivate the slide clamp upon closing a door of the pump, thereby allowing passage of fluid through the tube.
In a third exemplary aspect, a slide clamp for use in a fluid pump is disclosed. The slide clamp comprises a flange positioned at a distal end of the slide clamp, the flange configured to reciprocate in a sliding direction. The flange comprises a height greater than a thickness of the slide clamp in a direction substantially perpendicular to the sliding direction and a slip preventive feature preventing slippage of an operator's finger from the flange at least in the sliding direction.
The foregoing and other features, aspects and advantages of the embodiments of the present disclosure will become more apparent from the following detailed description and accompanying drawings.
Certain configurations of the present disclosure address and solve problems related to accidental fluid discharge when a pump door of a fluid delivery pump is open by provision of a flange fitted on a slide clamp that is a part of a flow stop mechanism. In certain aspects, the flange is configured to prevent accidental slippage of finger that may result in pressing of a release tab. Pressing the release tab when the pump door is open and a disposable portion is being loaded in the pump may defeat a flow-stop mechanism before the disposable portion is loaded completely, thereby causing undesirable fluid flow.
In certain configurations, the pump door is configured to deactivate the slide clamp upon closure of the pump door. Broadly speaking, at least two pump door configurations are possible. In the first pump door configuration, one or more bosses are included to control operation of the flow stop, resulting in deactivation of the flow stop after the pump door is closed. Additional operational details of such a pump door configuration can be found in the previously referenced U.S. Pat. No. 5,453,098. In the second pump door configuration, an opening is provided in the pump door through which a latching arm travels to deactivate the flow stop upon closure of the pump door. Additional operational details of such a pump door configuration can be found in U.S. Pat. No. 6,629,955 to Morris et al., incorporated herein by reference.
As shown in
The body 15 of the slide clamp 14 is penetrated from its top surface 17 to its bottom surface 19 by an elongated aperture 20. The elongated dimension of the aperture 20 is arranged on the slide clamp 14 to be parallel to the direction of the relative sliding movement between the base 12 and the slide clamp 14. Two side edges of the body 15 of the slide clamp 14 are fitted with rails 22 that lie parallel to the sliding direction (arrow 111). When the slide clamp 14 is slidingly engaged with the base 12, the rails 22 fit in a sliding fashion on two rail channels 27 on the top of the base 12 at the top of two frames 24 formed on the edges of the base 12. Alignment of the slide clamp 14 with the base 12 is accomplished by the fit of the rails 22 over the rail channels 27 of the frames 24, and by the fit of the body 15 of the slide clamp 14 between the frames 24.
Two flexible cantilevered locking arms 28 are molded into the top of the base 12, with their distal free ends 26 biased downwardly below the top surface 25 of the base 12. Biasing of the free ends 26 downwardly is accomplished by molding the locking arms 28 in a downwardly sloped configuration, but the biasing could also be accomplished by the use of springs or other means. A release tab 32 is formed on the locking arms 28, projecting upwardly from the locking arms 28 substantially parallel to the longitudinal axis of the tower 16. In the free state, when the locking arms 28 are sloped downwardly relative to the top surface 25 of the base 12, the release tab 32 is spaced away from the outer surface of the tower 16. The free ends 26 of the locking arms 28 can be flexed upwardly by pressing the release tab 32 toward the tower 16. Without departing from the spirit of the disclosure, one locking arm 28 can be used in place of the two shown, or each locking arm 28 can have a separate release tab 32.
Two locking projections 30 are molded on the top surface 17 of the body 15 of the slide clamp 14, with the projections 30 taking the form of ramps. The locking projections 30 are transversely positioned on the slide clamp 14 to align with the free ends 26 of the locking arms 28 when the slide clamp 14 is inserted into the base 12. The locking projections 30 are also longitudinally positioned to prevent the slide clamp 14 from being inserted into the base 12 far enough to move from its occluding position to its open position.
A flange 101 is provided at the distal end 103 of slide clamp 14, the distal end 103 being located farther away from the sliding direction (arrow 111) with respect to the proximate end 105 and the release tab 32. The flange 101 is provided on the slide clamp 14 to facilitate movement of the slide clamp 14 to the open position by pushing against the flange 101 in the sliding direction (arrow 111). The flange 101 is configured to be slip-resistant (i.e., prevent an inadvertent finger slip) when pushing the flange in the sliding direction. In certain configurations of the present disclosure, the flange 101 has a height great enough to allow secure placement of an operator's finger during pushing operation. To prevent finger-slip, the height of the flange 101, in the direction perpendicular to the sliding direction (arrow 111) may be chosen to be 2 millimeters or more, generally in the 5-10 millimeters range. In certain embodiments, the height of the flange 101 in the direction substantially perpendicular to the slide clamp 14 is larger than thickness of the slide clamp 14, thereby providing better support for an operator's finger during pushing operation than the slide clamp 14. The height of the flange 101 is practically limited in the depicted embodiment by the opening 109 in the pump door 130 so that the flange 101 does not inhibit closing of the pump door 130 during fluid delivery operation. However, in other embodiments, when a pump door 130 opening is not a limiting factor, the height of the flange 101 may be made greater to provide further assurance of finger slippage prevention.
As seen in
As seen in
Still referring to
Operative elements of the door and latch mechanism are shown schematically and designated as elements A, B, and C, to illustrate their interaction with the flow stop 10 of the present disclosure. The releasing boss A is formed on the door and positioned to contact the release tab 32 as the door is moved to the shut position, and to press the release tab 32 toward the tower 16. A pushing boss B is formed on the latch mechanism and positioned to contact the flange 101 on the slide clamp 14, as the latch is engaged, to push the slide clamp 14 from its occluding position to its open position, Finally, one or more pulling hooks C are formed on the latch mechanism and positioned to contact the pulling projections 40 as the latch is disengaged to pull the slide clamp 14 from its open position to its occluding position.
Element A of the door moves generally to the right as seen in
To use the flow stop 10 of the present disclosure, the slide clamp 14 is fully inserted into the base 12 until the open end 34 of the aperture 20 aligns with the longitudinal axis of the tower 16. The release tab 32 is manually pressed toward the tower 16 as necessary to allow full insertion of the slide clamp 14. A pumping tube 46 is selected for its appropriate size, flexibility, and durability. One end of the selected pumping tube 46 is attached to the tube connector 18 at the top end 21 of the tower 16 by being fit over the tube connector 18. One end of a selected IV tube 48 is threaded through the open end 34 of the aperture 20 and attached to the base 12 by being fit into the bottom end 23 of the tower 16. The slide clamp 14 is then manually withdrawn from the base 12 to occlude the IV tube 48, as depicted in
The other end of the pumping tube 46 is connected to a supply (not shown) of the chosen fluid to be pumped. The door 130 of the pump housing 122 is opened and the flow stop 10 is placed inside the door 130 with the base 12 securely mounted to the pump housing and the free ends 26 of the locking arms 28 projecting outwardly from the pump housing. The pumping tube 46 is placed in contact with the pumping mechanism (e.g., 144,
If the pump door 130 is to be opened, the latching mechanism must first be disengaged, which will move the elements B and C to the left, causing the pulling hooks C to contact the pulling projections 40 and pull the slide clamp 14 to the left, to its occluding position. The latching mechanism can be constructed by known means so that only after this occlusion occurs will the door 130 be unlatched. At this time, the door 130 can be opened. The locking arms 28, having engaged the locking projections 30, maintain the slide clamp 14 in its occluding position, even if the slide clamp 14 is pushed toward the base 12 with considerable force.
The latching mechanism can also be constructed by known means so that when the door 130 has been unlatched, the latching mechanism cannot be moved back to its latched position until the door 130 has been shut. Therefore, if the door 130 is to be shut, the release boss A will press the release tab 32 toward the tower 16 to release the locking arms 28 from engagement with the locking projections 30, and the slide clamp 14 can be subsequently moved to the open position as explained before.
In certain configurations, the flange 101 comprises more than one of the various slip-resistant designs. For example, the flange 101 is designed to have an angled top portion and at the same time be concavely shaped. Furthermore, although in the illustrated configurations, the flange 101 is shown to be generally rectangular, several other shapes (e.g., oval, circular) are possible within the scope of the present disclosure. In certain configurations, the flange 101 is fabricated as a separate element that is attached to the flow stop using rivets or glue, etc. In certain configurations, the flange 101 and the flow stop 10 form a single piece, typically manufactured by injection molding. Furthermore, the flange 101 comprises variety of materials, such as slip-resistant rubber, plastic, etc.
Although embodiments of the present disclosure have been described and illustrated in detail, it is to be clearly understood that the same is by way of illustration and example only and is not to be taken by way of limitation, the scope of the present invention being limited only by the terms of the appended claims.