Priming System for Infusion Devices
20230011520 · 2023-01-12
Inventors
Cpc classification
A61M39/227
HUMAN NECESSITIES
A61M5/152
HUMAN NECESSITIES
F04D9/006
MECHANICAL ENGINEERING; LIGHTING; HEATING; WEAPONS; BLASTING
F04D9/043
MECHANICAL ENGINEERING; LIGHTING; HEATING; WEAPONS; BLASTING
F04D9/004
MECHANICAL ENGINEERING; LIGHTING; HEATING; WEAPONS; BLASTING
A61M2205/3337
HUMAN NECESSITIES
A61M5/16809
HUMAN NECESSITIES
A61M2205/0216
HUMAN NECESSITIES
International classification
A61M5/145
HUMAN NECESSITIES
Abstract
Priming systems and infusion assemblies are provided. For example, a priming system comprises a priming conduit having a priming portion and a pressure portion. The priming portion is in fluid communication with a first fluid source, with an inlet and an outlet for ingress and egress of a first fluid from the first fluid source. The pressure portion is in fluid communication with a second fluid source connected by a connector. Disposed within the priming conduit are a biasing member and a valve having an open position and a closed position. The biasing member is in operable communication with the valve to urge the valve into the closed position such that the valve defaults to the closed position. The open position allows the first fluid to flow from the inlet to the outlet and the closed position prevents the first fluid from flowing from the inlet to the outlet.
Claims
1-20. (canceled)
21. A priming system, comprising: a priming conduit having: a priming portion in fluid communication with a first fluid source, the priming portion having an inlet for ingress of a first fluid from the first fluid source and an outlet for egress of the first fluid, wherein the inlet and the outlet are aligned, and a pressure portion in fluid communication with the second fluid source, wherein the second fluid source generates either a positive pressure or a negative pressure; a valve having an open position and a closed position, the valve comprising a linear actuator; and a biasing member disposed within the priming conduit, the biasing member in operable communication with the valve to urge the valve into the closed position such that the valve defaults to the closed position.
22. The priming system of claim 21, where in the linear actuator comprises a series of at least two dimensions and wherein the series of dimensions alternate smaller and larger in size.
23. The priming system of claim 21, wherein the priming portion and the pressure portion form an intersection.
24. The priming system of claim 23, wherein the valve is in the closed position when a dimension having a larger size blocks the intersection, preventing the first fluid from flowing from the inlet to the outlet.
25. The priming system of claim 23, wherein the valve is in the open position when the dimension having a smaller size is positioned in the intersection, allowing the first fluid to flow from the inlet, around the dimension, to the outlet.
26. The priming system of claim 21, wherein the positive pressure moves the valve linearly along the axis of the pressure conduit away from the second fluid source supplying the positive pressure to the pressure portion positioning the dimension having the smaller size at the intersection of the priming portion and the pressure portion.
27. The priming system of claim 21, wherein the negative pressure shifts the valve linearly along the axis of the pressure conduit in a direction towards the second fluid source supplying the negative pressure to the pressure portion into the open position such that the dimension having the smaller size is at the intersection of the priming portion and the pressure portion.
28. The priming system of claim 21, wherein the first fluid does not flow into the pressure portion of the priming conduit.
29. The priming system of claim 21, wherein the valve and the biasing member are configured to stop prior to allowing the second fluid into the priming portion.
30. The priming system of claim 21, wherein the priming conduit further comprises a stop, and wherein the biasing member is in contact with the stop such that the biasing member biases against the stop to control the position of the valve.
31. The priming system of claim 21, wherein the pressure portion is Y-shaped with a stem and at least one arm.
32. The priming system of claim 31, wherein the stem of the pressure portion intersects the priming portion, and the stop, biasing member, and valve are disposed within the stem.
33. The priming system of claim 31, wherein a first arm of the pressure portion includes the connector connecting the second fluid source.
34. The priming system of claim 31, wherein a second arm of the pressure portion provides an additional area within the pressure portion to build sufficient pressure with the second fluid to open the valve.
35. The priming system of claim 34, wherein the second arm of the pressure portion further comprises a plug.
36. The priming system of claim 21, further comprising a seal disposed between the valve and the pressure portion of the priming conduit.
37. The priming system of claim 36, wherein the seal is an O-ring extending about the valve and in contact with an inner surface of the pressure portion of the priming conduit.
38. The priming system of claim 21, wherein the valve includes a piston having a surface area and wherein the piston has a varying diameter to minimize the surface area in contact with the priming conduit.
39. The priming system of claim 21, wherein the axial alignment of the priming portion minimizes resistance and enables efficient flow of the first fluid through the priming conduit.
Description
BRIEF DESCRIPTION OF THE DRAWINGS
[0014] 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:
[0015]
[0016]
[0017]
DETAILED DESCRIPTION
[0018] 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.
[0019] Moreover, the particular naming of the components, capitalization of terms, the attributes, data structures, or any other programming or structural aspect is not mandatory or significant, and the mechanisms that implement the invention or its features may have different names, formats, or protocols. Also, the particular division of functionality between the various components described herein is merely exemplary and not mandatory; functions performed by a single component may instead be performed by multiple components, and functions performed by multiple components may instead performed by a single component.
[0020] Further, the detailed description uses numerical and letter designations to refer to features in the drawings. Like or similar designations in the drawings and description have been used to refer to like or similar parts of the invention. As used herein, the terms “first,” “second,” and “third” may be used interchangeably to distinguish one component from another and are not intended to signify location or importance of the individual components.
[0021] Referring to the drawings,
[0022] More particularly, pump 102 defines a reservoir that serves as a pressurized fluid source, holding medicinal fluid, such as local anesthetics, and providing a source of fluid under pressure. Pump 102 forces the medicinal fluid through a tubing or conduit 108. Conduit 108 forms a continuous flow path 110 for delivery of the medicinal fluid into a wound site nerve bundle or the blood stream of a patient P. In the depicted exemplary embodiment, conduit or tubing 108 defines an outlet 112 connecting the continuous flow path 110 to a catheter 114 that delivers the medicinal fluid to patient P. In such embodiments, conduit 108 and catheter 114 may together define continuous flow path 110 from pump 102 to patient P.
[0023] Further, in some embodiments, infusion assembly 100 may be configured to provide for bolus delivery. In such configurations, conduit 108 may split into a continuous or primary flow path 110 and a controlled bolus flow path 140. Thus, medicinal fluid may be delivered into a wound site nerve bundle or the blood stream of patient P from pump 102 via the continuous or primary flow path or from a bolus delivery device 150 via the controlled bolus flow path.
[0024] Pump 102 preferably accommodates a volume from about 100 to 500 ml of fluid under a pressure of up to approximately 30 psi. In some embodiments, the pump may hold the fluid under a pressure of about 10 psi to about 30 psi and, in other embodiments, under a pressure of about 15 psi to about 25 psi. More particularly, pump 102 has an inner core 116 extending between upper support member 104 and lower support member 106 along axial direction A. Inner core 116 is surrounded by an elastomeric bladder 118 within a housing 120. Inner core 114 preferably has an inlet port 122, e.g., to fill bladder 118 with fluid, and an outlet port 124 in fluid communication with conduit 108, e.g., to dispense the fluid from bladder 118 to patient P through flow path 110. Fluid is held under pressure within elastomeric bladder 118 and flows from elastomeric bladder 118 into conduit 108 through outlet port 124, preferably flowing at a controlled and predictable rate. Alternatively, conduit 108 may be sized to serve as a flow restrictor. Further, elastomeric bladder 118 preferably is 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, silicone rubber, or the like.
[0025] Exemplary pumps are described in U.S. Pat. Nos. 7,959,623 and 5,254,481, which are hereby incorporated by reference. A variety of other conventional pumps also may be used. For example, the pumps described in U.S. Pat. Nos. 5,080,652 and 5,105,983, which are hereby incorporated by reference, may be used. As will be understood by those of skill in the art, other suitable electronic or mechanical pumps offered by other manufacturers may be used as well.
[0026] Continuing with
[0027] An optional filter 128 downstream of clamp 126 separates the fluid from contaminates and other undesired particles that may be found within the fluid. Filter 128 also preferably eliminates air from fluid flow path 110. One such filter 128 is described in U.S. Pat. No. 6,350,253, which is hereby incorporated by reference. Of course, other suitable filters recognized in the industry may be used to capture undesired particles and/or remove air from the system.
[0028] As further shown in
[0029] The particular arrangement of clamp 126, filter 128, and flow regulator 130 (or glass tube 132) described herein is merely exemplary. These elements, if present, may be arranged in any order, as will be easily understood by those skilled in the art. Desirably, however, glass orifice tube 132 is located downstream of filter 128 when orifice tube 132 and filter 128 are provided in infusion assembly 100.
[0030] In the exemplary embodiment illustrated in
[0031] Generally, the bolus delivery device 150 is configured to receive fluid, elastically expand to pressurize the fluid, store the pressurized fluid, and dispense the pressurized fluid while avoiding over-administration of a medicinal fluid to the patient. Downstream from the bolus delivery device 150, the continuous flow path 110 and the bolus flow path 140 converge into a single flow path. Further, as illustrated in
[0032] The flow restrictor 146 restricts the flow of fluid to the bolus delivery device 150, e.g., to help control the bolus refill rate. For example, fluid from the pump 102 refills a reservoir of the device 150 following the administration of a bolus dose to the patient P. By controlling the refill rate of the reservoir, the flow restrictor 146 may be one feature of the bolus system that helps prevent over-administration of medication to the patient, e.g., by limiting or restricting the delivery of additional medicinal fluid to the patient within a time period following the administration of a bolus dose of the medicinal fluid. As shown in
[0033] Although described herein with respect to the bolus system of the infusion assembly 100, it should be appreciated that the priming system 200 described herein also may be used to prime infusion assembly tubing and/or other components of the infusion assembly 100, such as flow selection devices or the like. Of course, the priming system 200 may be used with other appropriate assemblies, devices, or systems as well.
[0034] Turning now to
[0035] The pressure portion 206 of priming system 200 is in fluid communication with a second fluid source 214 that provides a second fluid F.sub.2 to the priming system 200. More particularly, the pressure portion 206 includes a connector 216 for connecting the second fluid source 214 to the pressure portion. In the depicted embodiment, the connector 216 is a luer connector and the second fluid source 214 is a syringe that supplies a second fluid F.sub.2 such as saline or the like, but in other embodiments, other types of connectors 216, fluid sources 214, and second fluids F.sub.2 also may be used. For example, the second fluid source 214 may be a vacuum source that generates or supplies a vacuum within the pressure portion 206. Thus, in various embodiments, the second fluid source 214 and second fluid F.sub.2 may generate either a positive pressure or a negative pressure within the pressure portion 206 of the priming conduit 202.
[0036] As shown in
[0037] As illustrated in
[0038] More specifically, for the illustrated piston embodiment, the first diameter d.sub.1 of the valve 218 spans the intersection 222 when the valve 218 is in the closed position. Because the segments of the valve 218 having the first diameter d.sub.1 contact the inner surface 220 of the priming portion 206 of the priming conduit 202, the valve 218 prevents the first fluid F.sub.1 from flowing across the intersection 222, i.e., the valve 218 blocks the intersection 222 and thereby prevents the first fluid F.sub.1 from flowing from the inlet 210 of the priming portion 204 to the outlet 212 of the priming portion 204. However, when the valve 218 is in the open position, a segment of the valve 218 having the second diameter d.sub.2 spans the intersection 222. Because the second diameter d.sub.2 of the valve 218 is smaller than the first diameter d.sub.1, the second diameter d.sub.2 segment of the valve 218 does not block the intersection 222 of the priming and pressure portions 204, 206, and the first fluid F.sub.1 may flow from the priming portion inlet 210 around the valve 218 to the priming portion outlet 212, where the first fluid F.sub.1 reenters the bolus flow path 140 to flow on to the bolus delivery device 150 and any other downstream components of the infusion assembly 100.
[0039] As illustrated in
[0040] The piston-style valve 218 of the embodiment illustrated in
[0041] As described above, the valve 218 may have a varying diameter d; specifically, the exemplary valve 218 has a first diameter d.sub.1 and a second diameter d.sub.2 that is smaller than the first diameter d.sub.1. The position of the first and second diameters d.sub.1 and d.sub.2 with respect to the intersection 222 between the priming and pressure portions 204, 206 of the priming conduit 202 determine whether the valve 218 is open, permitting the first fluid F.sub.1 to flow through the priming portion 204, or closed, preventing the first fluid F.sub.1 from flowing through the priming portion 204. However, the varying diameter d of the valve 218 also varies the surface area of the valve 218 in contact with the inner surface 220 of the pressure portion 206. More particularly, the valve 218, configured as a piston in the embodiment of
[0042] As further illustrated in
[0043] With the valve 218 opened by the positive or negative pressure of the second fluid F.sub.2 supplied by the second fluid source 214 as shown in
[0044] The priming system 202 also may include other safety features that, in particular, prevent bypassing the flow control provided by the flow restrictor 146 to help prevent over-administration of medication to the patient. For instance, the pressure required to move the valve 218 to the open position of
[0045] Accordingly, as described herein, a system is provided for faster priming of various components of an infusion assembly. In exemplary embodiments, the priming system described herein allows faster priming of certain components of the infusion assembly by bypassing a flow restrictor that otherwise controls the flow rate of fluid to the components. However, the priming system also includes features for discouraging or preventing continuous and/or non-priming related bypassing of the flow restrictor, such that the flow rate may be controlled per the design of the infusion system. For instance, the priming system defaults to a closed position, such that the fluid of the infusion assembly is permitted to flow through the priming system, bypassing the flow restrictor, upon a positive action by a user. In particular embodiments, the positive action may be the connection of a second fluid source that applies pressure to a check valve controlling flow through the priming system, and the ability to connect the second fluid source may be disabled after priming, e.g., by removing or breaking off a connector, such that the priming system returns to its default closed position and cannot be re-opened. Other benefits and advantages of the subject matter described herein also may be realized by those of ordinary skill in the art.
[0046] 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.