Variable Fluid Flow Rate Control Device
20230048874 · 2023-02-16
Inventors
Cpc classification
A61M5/16813
HUMAN NECESSITIES
A61M5/165
HUMAN NECESSITIES
A61M2205/0216
HUMAN NECESSITIES
International classification
A61M5/168
HUMAN NECESSITIES
A61M5/14
HUMAN NECESSITIES
Abstract
A flow selector having features for controlling the flow rate of a fluid over a continuous range of flow rates is provided. In particular, a flow selector including a flow rate selection mechanism is provided, where the flow rate selection mechanism provides more precise control of the fluid flow rate. A flow selector comprising a needle valve for controlling the flow rate of a fluid over a continuous range of flow rates also is provided.
Claims
1. A flow selector for selectively controlling a flow rate of a fluid, the flow selector comprising: an inlet tube; an outlet tube; a flow rate selection mechanism, the flow rate selection mechanism including a shaft having a distal end and a proximal end, and a seat that receives the distal end of the shaft, wherein the flow rate selection mechanism is positioned between the inlet tube and the outlet tube to permit an ingress of fluid from the inlet tube and an egress of fluid to the outlet tube, and an enclosure for holding the inlet tube, the outlet tube, and the flow rate selection mechanism in position relative to each other, the enclosure having an inlet opening for receiving the inlet tube, an outlet opening for receiving the outlet tube, and a shaft opening for receiving the shaft of the flow rate selection mechanism.
2. The flow selector of claim 1, wherein the shaft of the flow rate selection mechanism comprises indicia for indicating a selected flow rate to a user of the flow selector.
3. The flow selector of claim 2, wherein the indicia comprise a series of numbers representing a range of flow rates selectable using the flow selector.
4. The flow selector of claim 1, wherein the enclosure comprises a first side and a second side, the second side being opposite the first side, and wherein the first side defines the inlet opening and the shaft opening and the second side defines the outlet opening.
5. The flow selector of claim 1, wherein the enclosure comprises a first side and a second side, the second side being opposite the first side, and wherein the first side defines the inlet opening and the second side defines the outlet opening and the shaft opening.
6. The flow selector of claim 1, wherein the enclosure comprises a first side and a second side, the second side being opposite the first side, and wherein the first side defines the inlet opening and the outlet opening and the second side defines the shaft opening.
7. The flow selector of claim 1, wherein the enclosure comprises a first side, a second side, and a third side, the second side being opposite the first side and the third side being between the first side and the second side, and wherein the first side defines the inlet opening, the second side defines the outlet opening, and the third side defines the shaft opening.
8. The flow selector of claim 1, wherein the distal end of the shaft and the seat of the flow rate selection mechanism are positioned within the enclosure and the proximal end of the shaft of the flow rate selection mechanism is positioned outside the enclosure.
9. The flow selector of claim 1, wherein the proximal end of the shaft comprises a control knob.
10. The flow selector of claim 1, wherein the flow rate selection mechanism is a needle valve.
11. A flow selector for selectively controlling a flow rate of a fluid, the flow selector comprising: an inlet tube; an outlet tube; a needle valve, the needle valve including a shaft having a distal end and a proximal end, and a seat that receives the distal end of the shaft, wherein the distal end of the shaft is tapered in shape and the seat has a recess with a shape complementary to the shape of the distal end of the shaft, and an enclosure for holding the inlet tube, the outlet tube, and the needle valve in position relative to each other, the enclosure having an inlet opening for receiving the inlet tube, an outlet opening for receiving the outlet tube, and a shaft opening for receiving the shaft of the needle valve, wherein the distal end of the needle valve is positioned between the inlet tube and the outlet tube within the enclosure to permit an ingress of fluid from the inlet tube and an egress of fluid to the outlet tube.
12. The flow selector of claim 11, wherein the shaft of the needle valve comprises indicia for indicating a selected flow rate to a user of the flow selector.
13. The flow selector of claim 12, wherein the indicia comprise a series of numbers representing a range of flow rates selectable using the flow selector.
14. The flow selector of claim 11, wherein the distal end of the shaft is received within the recess of the seat, and wherein the distal end of the shaft is configured to move along an axial direction within the recess to adjust a flow rate of fluid through the needle valve.
15. The flow selector of claim 11, wherein the shaft of the needle valve comprises a control knob for manual control of the flow rate of the fluid by a user of the flow selector.
16. The flow selector of claim 11, wherein the enclosure comprises a first side and a second side, the second side being opposite the first side, and wherein the first side defines the inlet opening and the shaft opening and the second side defines the outlet opening.
17. The flow selector of claim 11, wherein the enclosure comprises a first side and a second side, the second side being opposite the first side, and wherein the first side defines the inlet opening and the second side defines the outlet opening and the shaft opening.
18. The flow selector of claim 11, wherein the enclosure comprises a first side and a second side, the second side being opposite the first side, and wherein the first side defines the inlet opening and the outlet opening and the second side defines the shaft opening.
19. The flow selector of claim 11, wherein the enclosure comprises a first side, a second side, and a third side, the second side being opposite the first side and the third side being between the first side and the second side, and wherein the first side defines the inlet opening, the second side defines the outlet opening, and the third side defines the shaft opening.
Description
BRIEF DESCRIPTION OF THE DRAWINGS
[0010] A full and enabling disclosure of the present invention, including the best mode thereof, directed to one of ordinary skill in the art, is set forth in the specification, which makes reference to the appended figures, in which:
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DETAILED DESCRIPTION
[0023] Reference now will be made in detail to embodiments of the invention, one or more examples of which are illustrated in the drawings. Each example is provided by way of explanation of the invention, not limitation of the invention. In fact, it will be apparent to those skilled in the art that various modifications and variations can be made in the present invention without departing from the scope or spirit of the invention. For instance, features illustrated or described as part of one embodiment can be used with another embodiment to yield a still further embodiment. Thus, it is intended that the present invention covers such modifications and variations as come within the scope of the appended claims and their equivalents.
[0024] Referring to
[0025] In some configurations, dispensing device 100 may provide for bolus delivery. In such embodiment, conduit 104 splits into continuous or primary flow path 106 and into a controlled bolus flow path (not illustrated) for delivery into a wound site nerve bundle or the blood stream of patient P. Other aspects of the bolus delivery system are described more fully herein.
[0026] Pump 102 preferably accommodates about from 100 to 500 ml of fluid under a pressure of approximately 10 to 15 psi. Pump 102 has an inner core 108 surrounded by an elastomeric chamber 110 within a housing 112. Inner core 108 preferably has an inlet port 114 to fill the pump and an outlet port 116 in fluid communication with the conduit or tubing 104. Elastomeric chamber 110 is preferably constructed from a resilient material that may comprise a variety of elastomeric compositions, well known in the art, including vulcanized synthetic polyisoprenes, natural latex, natural rubber, synthetic rubber or silicone rubber. Exemplary pumps are described in U.S. Pat. No. 5,254,481, which is hereby incorporated by reference. A variety of other conventional pumps may be used, so long as they can impart the desired pressure on the fluid. For example, the pumps described in U.S. Pat. Nos. 5,080,652 and 5,105,983, which are hereby incorporated by reference may also be used, as well as other suitable electronic or mechanical pumps offered by other manufacturers as will be understood by those of skill in the art.
[0027] Fluid is held under pressure within elastomeric chamber 110 and flows from elastomeric chamber 110 through outlet port 116 into conduit 104 at a controlled and predictable rate. Alternatively, conduit 104 may be sized to serve as a flow restrictor.
[0028] An optional clamp 118 is positioned in the flow path 106 downstream from conduit 104. Clamp 118 can compress the flow path 106 such that fluid flow from pump 102 is occluded. Such occlusion is advantageous for the transportation and preparation of fluid delivery or dispensing device 100 as described herein. An exemplary clamp 118 also is described in U.S. Pat. No. 6,350,253, which is hereby incorporated by reference. However, a variety of other conventional clamps known in the industry may be used to occlude the flow of fluid from pump 102 through the flow path 106 such as, e.g., compression clamps, C clamps, roller clamps, and the like.
[0029] An optional filter 120 downstream of clamp 118 separates the fluid from contaminates and other undesired particles that may be found within the fluid. Filter 120 also preferably eliminates air from the fluid path 106. One such filter 120 is described in U.S. Pat. No. 6,350,253, which is hereby incorporated by reference. Other suitable filters recognized in the industry may be used to capture undesired particles and/or remove air from the system.
[0030] In some embodiments, device 100 for dispensing fluid to patient P utilizes at least one flow detector assembly 122 including a flow detector to indicate a flow condition. Desirably, one flow detector assembly 122 is located above or upstream of a flow selector 200 and one flow detector assembly 122 is located below or downstream of flow selector 200, as illustrated in
[0031] Flow detector 122 provides a signal when the flow condition of the fluid in continuous flow path 106 has changed from a predetermined flow condition. Generally speaking, the flow rate in continuous flow path 106 can be associated with a fluid flow state such as, for example, a continuous and steady flow rate. For example, flow detector 122 may be configured to provide a signal that the flow rate of the fluid in continuous flow path 106 is less than the predetermined flow rate, within a range of predetermined flow rates, or greater than a predetermined flow rate.
[0032] As further illustrated in
[0033] As previously stated, some embodiments of device 100 may incorporate a bolus delivery system. In an exemplary embodiment, the bolus delivery system accumulates a large quantity of fluid from the bolus flow path leading from reservoir 102 and holds the fluid under pressure until the bolus dose is triggered by a patient operable actuator for release into patient P. Such a large volume bolus delivery system is configured to receive fluid, elastically expand to pressurize fluid, store the pressurized fluid, and dispense the pressurized fluid, while avoiding bolus refill during bolus delivery or after bolus delivery but before it is enabled to elastically expand in a subsequent delivery cycle. The actuator is configured such that it does not require effort to force the fluid out of the bolus reservoir and such that when actuated by the patient, fluid is permitted to flow out of the bolus reservoir to the patient without further action by the patient. The large volume bolus delivery system is desirably a PCA device as described at, for example, U.S. Pat. No. 6,936,035 for “Patient Controlled Drug Administration Device” issued Aug. 30, 2005 to Rake et al. and U.S. Pat. No. 8,308,688 for “Large-Volume Bolus Patient Controlled Drug Administration Device” issued Nov. 13, 2012 to Valle et al., the contents of each being incorporated herein by reference.
[0034] Downstream from the large volume bolus delivery system, continuous flow path 106 and the bolus dose flow path converge into a single flow path to patient P. An optional clamp and an optional filter may be positioned in the bolus flow path downstream from conduit 104. The clamp can compress the bolus flow path such that fluid flow from pump 102 is occluded. Such occlusion is advantageous for the transportation and preparation of fluid delivery device 100 as described herein.
[0035] The release-rate of the bolus dose to patient P is controlled by the decompression of the elastomeric bolus reservoir, by the pressure gradient at the actuator, and the diameter of the catheter 126. Advantageously, patient P does not have to provide pressure to force fluid out of the large volume bolus delivery system into the narrower bolus flow path. Rather, patient P can turn the stopcock or release the push button to administer the bolus dose. If patient P activates the bolus actuator or valve prior to the time the bolus reservoir has filled to its capacity, patient P receives less than the full amount of the bolus dose. In effect, this prevents the patient from self-administering more than the maximum desired amount of fluid per the time specified as a large volume bolus dose.
[0036] A flow detector assembly 122 with its flow detector may be located downstream of the location where continuous flow path 106 and the bolus dose flow path converge into a single flow path. In this location, the flow detector 122 provides a signal that the flow rate of the fluid in the single flow path is less than a predetermined flow rate; such a signal indicates a flow state that is less than a continuous and substantially constant flow rate of fluid.
[0037] Referring now to
[0038] In the exemplary embodiment shown in
[0039] Flow selector 200 also includes an enclosure 204 for holding an inlet tube 206 and an outlet tube 208 (
[0040] As illustrated in
[0041]
[0042] As shown in
[0043]
[0044] Referring back to
[0045] Flow rate selection mechanism 210 also includes a control knob 228 having a protruding portion 230; control knob 228 is positioned at proximal end 224 of shaft 212. Protruding portion 230 may, e.g., help a user of flow selector 200 visualize and/or keep track of the rotation of shaft 212 or help a user grip control knob 228 to manually adjust the flow rate using flow selector 200. Alternatively, control knob 228 may have other configurations, and in some embodiments, control knob 224 may be omitted, e.g., when flow selector 200 is automatically adjustable using a controller assembly or the like.
[0046] As shown in
[0047] As previously stated, threaded portion 226 permits shaft 212 to rotate, e.g., through electromechanical means or by the application of a rotational force to control knob 228 by a user of flow selector 200. Shaft 212 is received within recess 219 of seat 218 such that, when rotated, shaft 212 may be advanced or retracted along the axial direction A within recess 219. That is, when rotated in one direction, shaft 212 advances toward distal end 214 of flow rate selection mechanism 210. When rotated in the opposite direction, shaft 212 retracts away from distal end 214. Thus, by rotating shaft 212, a smaller or larger portion of shaft 212 may be received within recess 219 of seat 218 such that more or less of volume V of recess 219 is occupied by shaft 212.
[0048] As described, flow rate selection mechanism 210 receives an ingress of fluid from inlet tube 206 and permits an egress of fluid to outlet tube 208. The fluid received at the inlet of flow rate selection mechanism 210 is at a relatively constant pressure, i.e., flow rate selection mechanism 210 is operated at relatively constant inlet pressures. Typical pressure profiles of the fluid encountered by flow rate selection mechanism 210 during its operation generally are as described at, e.g., U.S. Pat. No. 8,968,242 for “Inflatable Elastomeric Pump for an Infusion Assembly,” issued Mar. 3, 2015 to Tefer, et al., the contents of which is incorporated herein by reference. Tefer, et al. illustrates pressure profiles of the fluid environment downstream of an elastomeric pump, which would be typical of the operating pressure profiles experienced by flow rate selection mechanism 210.
[0049] Referring now to
[0050] In this way, flow selector 200 controls the flow rate within dispensing device 100. Rotating shaft 212 to advance distal end 222 toward distal end 214 of flow rate selection mechanism 210 decreases the available volume V.sub.A within recess 219, which decreases the flow rate of fluid through flow rate selection mechanism 210. Thus, the flow rate of fluid through selection mechanism 210 after advancing shaft 212 within recess 219 is less than the flow rate of fluid through selection mechanism 210 prior to such rotation of shaft 212. Rotating shaft 212 to retract distal end 222 away from distal end 214 of flow rate selection mechanism 210 increases the available volume V.sub.A within recess 219, which increases the flow rate of fluid through flow rate selection mechanism 210. Therefore, the flow rate of fluid through selection mechanism 210 after retracting shaft 212 within recess 219 is greater than the flow rate of fluid through selection mechanism 210 prior to such rotation of shaft 212. Accordingly, by rotating shaft 212, e.g., automatically or manually, a flow rate for the fluid downstream of flow rate selection mechanism 210 can be selected.
[0051] Constructing flow selector 200 as described above facilitates precise control of the flow rate within dispensing device 100. More particularly, the flow rate is adjustable on a continuous scale such that any appropriate flow rate, e.g., for intravenous or intramuscular drug delivery or for other applications of dispensing device 100, may be selected from zero flow to maximum flow, i.e., from no flow to the maximum flow rate attainable in the device. That is, even slight rotations of shaft 212 change the available volume V.sub.A of recess 219, which may change the flow rate of fluid through flow rate selection mechanism 210. Thus, the flow rate can be adjusted precisely and over an entire, continuous range of flow rate values, rather than a range of discrete flow rates.
[0052] In some embodiments, shaft 212 of flow rate selection mechanism 210 includes indicia 232 along shaft 212 for indicating a selected flow rate to a user of the flow selector 200. As illustrated in
[0053] Referring now to
[0054] Referring particularly to
[0055] In the exemplary embodiment illustrated in
[0056] Referring now to
[0057] As shown in
[0058] It should be readily understood that references to first side 241, second side 242, third side 243, and fourth side 244 of enclosure 204 in
[0059] This written description uses examples to disclose the invention, including the best mode, and also to enable any person skilled in the art to practice the invention, including making and using any devices or systems and performing any incorporated methods. The patentable scope of the invention is defined by the claims and may include other examples that occur to those skilled in the art. Such other examples are intended to be within the scope of the claims if they include structural elements that do not differ from the literal language of the claims or if they include equivalent structural elements with insubstantial differences from the literal language of the claims.