Reusable fluid pumping device

Abstract

Described herein is a pump assembly for use with an IV set. The pump assembly includes a rotatable crank, a piston rod, and a diaphragm assembly. The crank includes a crank profile defining multiple lobes. The piston rod includes a first follower and a second follower spaced from the first follower. Rotation of the crank relative to the piston rod reciprocates the piston rod relative to the crank. The diaphragm assembly includes a housing and a diaphragm member. The diaphragm member is coupled to the housing and cooperatively defines a volume in fluid communication with the IV set. The diaphragm member is movable between an extended position configured to draw fluid from the IV set and a retracted position configured to expel fluid into the IV set. The diaphragm member is coupled to the piston rod to reciprocate the diaphragm member.

Description

[Technical Field]

[0001] The present disclosure relates generally to infusion sets, and particularly to pumping devices for infusion sets. [Background technology]

[0002] Medical procedures often involve infusing a patient with a medical fluid (e.g., saline, liquid medication, or blood) using an intravenous (IV) catheter connected to a fluid source, such as an IV bag, through an arrangement of flexible tubing and fittings commonly referred to as an "IV set." During certain operations, devices may be used to pump medical fluids, such as blood, into a patient. In some applications, certain pumps may not provide sufficient flow rate, causing user fatigue and increasing the complexity and duration of certain surgical procedures. Summary of the Invention

[0003] The disclosed subject matter relates to a pump for use with an IV set. In certain embodiments, a pump assembly for use with an IV set is disclosed, the pump assembly including a rotatable crank having a crank profile, the crank profile defining a plurality of lobes, and a piston rod having a first follower and a second follower spaced from the first follower, the first follower contacting the crank profile to selectively advance the piston rod and the second follower contacting the crank profile to selectively retract the piston rod, wherein rotation of the crank relative to the piston rod moves the piston rod relative to the crank. a piston rod for reciprocating the diaphragm; and a diaphragm assembly comprising: a housing; and a resilient diaphragm member coupled to the housing and cooperatively defining a volume in fluid communication with the IV set, the diaphragm member being movable between an extended position configured to increase the volume and draw fluid from the IV set and a retracted position configured to decrease the volume and expel fluid into the IV set, the diaphragm being coupled to the piston rod for reciprocating the diaphragm member between the extended and retracted positions.

[0004] In certain embodiments, a pump assembly for use with an IV set is disclosed, the pump assembly comprising: a drive assembly including a drive assembly housing with a plurality of tabs, a piston rod with an end extending through the drive assembly housing between the plurality of tabs, and a drive mechanism configured to reciprocate the piston rod; a diaphragm assembly configured to be removably coupled to the drive assembly, the diaphragm assembly including a diaphragm housing with a plurality of windows, the plurality of windows configured to removably engage a plurality of tabs on the drive assembly housing; and a diaphragm assembly including: a resilient diaphragm member coupled to the housing and cooperatively defining a volume in fluid communication with the IV set, the diaphragm member movable between an extended position configured to increase the volume and draw fluid from the IV set and a retracted position configured to decrease the volume and expel fluid into the IV set, the diaphragm being removably coupled to the piston rod to reciprocate the diaphragm member between the extended and retracted positions.

[0005] In certain embodiments, a pump assembly for use with an IV set is disclosed, the pump assembly comprising: a rotatable crank having a crank profile; a piston rod having first and second followers, each in contact with the crank profile, wherein rotation of the crank relative to the piston rod reciprocates the piston rod relative to the crank; a biasing member coupled to the crank and configured to rotate the crank; a keyed shaft coupled to the biasing member, the keyed shaft being rotatable to impart energy to the biasing member; and a diaphragm assembly comprising: a housing; and a resilient diaphragm member coupled to the housing and cooperatively defining a volume in fluid communication with the IV set, the diaphragm member being movable between an extended position configured to draw fluid from the IV set and a retracted position configured to expel fluid to the IV set, the diaphragm being coupled to the piston rod to reciprocate the diaphragm member between the extended and retracted positions.

[0006] It is understood that various configurations of the subject technology will be readily apparent to those skilled in the art from this disclosure, and various configurations of the subject technology are shown and described herein by way of example. As will be understood, the subject technology is capable of other and different configurations, and its several details are capable of modification in various other respects, all without departing from the scope of the subject technology. Accordingly, the summary, drawings, and detailed description are to be regarded as illustrative in nature, and not as restrictive.

[0007] The accompanying drawings, which are included to provide a further understanding and are incorporated in and constitute a part of this specification, illustrate disclosed embodiments and, together with the description, serve to explain the principles of the disclosed embodiments. [Brief explanation of the drawings]

[0008] [Figure 1]FIG. 1 illustrates an IV set according to certain aspects of the present disclosure. [Figure 2] FIG. 2 illustrates the pumping assembly shown in FIG. 1. [Figure 3] FIG. 2 illustrates a diaphragm assembly of the pumping assembly shown in FIG. 1. [Figure 4] FIG. 3 is an exploded view of the drive assembly of the pumping assembly of FIG. 2. [Figure 5] FIG. 5 is a partial cross-sectional view of the drive assembly of FIG. 4. [Figure 6] FIG. 5 is a detailed view of the drive mechanism of the drive assembly of FIG. 4. [Figure 7] FIG. 10 is a detailed view of the junction of the drive assembly and the diaphragm assembly. [Figure 8] FIG. 10 is a detailed view of the attached drive assembly and diaphragm assembly. [Figure 9] FIG. 10 is a detailed view of the piston rod of the drive assembly and the diaphragm of the diaphragm assembly. DETAILED DESCRIPTION OF THE INVENTION

[0009] The disclosed pump assembly includes a drive assembly having a rotatable crank capable of translating or reciprocating a piston rod, which actuates a diaphragm in fluid communication with the medical fluid. The drive assembly configuration can enable high flow rates while allowing the assembly to be easily actuated by a clinician. Furthermore, the drive assembly can be separated or removably attached to the diaphragm assembly. Advantageously, by allowing the drive assembly to be removed from the diaphragm assembly, the drive assembly can be reused and the diaphragm assembly, which contacts the medical fluid, can be discarded after use. Furthermore, the drive assembly can be energized by a biasing member. The biasing member allows the pump assembly to passively pump the medical fluid to the patient.

[0010] The detailed description set forth below is intended as a description of various configurations of the subject technology and is not intended to represent the only configurations in which the subject technology may be practiced. The detailed description includes specific details for the purpose of providing a thorough understanding of the subject technology. However, it will be apparent to those skilled in the art that the subject technology may be practiced without these specific details. In some instances, well-known structures and components are shown in block diagram form to avoid obscuring the concepts of the subject technology. Similar components are labeled with the same element numbers for ease of understanding. Reference numbers may be suffixed to indicate separate instances of common elements, but are generally referred to by the same number without the suffix.

[0011] While the following description is directed to administering medical fluids using the disclosed pumping device, it should be understood that this description is merely an example of use and is not intended to limit the scope of the claims. Various aspects of the pumping device may be used in any application where it is desirable to provide increased fluid flow with reduced user fatigue.

[0012] The disclosed pumping assembly overcomes several challenges found with certain conventional pumps. One challenge with certain conventional pumps is that they can have low flow rates and can be difficult to use for extended periods of time. Certain conventional hand pumps can cause clinician fatigue during use, making their use undesirable.

[0013] Therefore, in accordance with the present disclosure, it would be advantageous to provide a pumping assembly as described herein that allows for high flow rates and extended use without clinician fatigue.

[0014] Next, an example of a pumping assembly that allows for high flow rates and long-term use will be described.

[0015] 1 illustrates an IV set 100 according to certain embodiments of the present disclosure. As described herein, IV set 100 utilizes a pumping assembly 120 to deliver fluid from a fluid source, such as a container, through tubing 106 to a patient.

[0016] In the illustrated example, fluid from a fluid source is introduced into tubing 106 of IV set 100. As shown, tubing 106 may terminate in connector 102 to facilitate coupling and / or fluid communication with the fluid source. In some embodiments, connector 102 may be a connector spike that pierces a membrane of a container to allow fluid communication from the container to tubing 106. Optionally, tubing 106 may be coupled to a patient via port 112.

[0017] In some applications, additional medical fluids or medical treatments may be introduced into the patient via IV set 100. Optionally, additional medical fluids or medical treatments may be introduced into IV set 100 via infusion site 110. Additionally, clamps 104, 108 may control the flow of fluids through tubing 106 of IV set 100.

[0018] In the illustrated example, pumping assembly 120 moves, transfers, or otherwise directs medical fluid from a container or other fluid source to a patient via tubing 106. As described herein, pumping assembly 120 enables passive pumping of medical fluid at high flow rates and low refill times. Additionally, portions of pumping assembly 120, such as drive assembly 140, may be reused and removably connected to disposable portions of pumping assembly 120, such as diaphragm assembly 130.

[0019] Figure 2 illustrates the pumping assembly 120 shown in Figure 1. Referring to Figures 1 and 2, the pumping assembly 120 can pump a medical fluid, such as blood for transfusion, from a tube 106 connected to a fluid inlet 138a to a tube 106 connected to a fluid outlet 138b. In the illustrated example, the pumping assembly 120 includes a drive assembly 140 that actuates a diaphragm assembly 130 to move the fluid from the fluid inlet 138a to the fluid outlet 138b.

[0020] As shown, a piston rod 150 of the drive assembly 140 may reciprocate to move the diaphragm 134 of the diaphragm assembly 130 to cyclically shift or move fluid between a fluid inlet 138 a and a fluid outlet 138 b. A rotatable crank 160 may engage features on the piston rod 150 to allow rotation of the crank 160 to actuate or translate the piston rod 150 in a reciprocating manner.

[0021] In some embodiments, crank 160 can be rotated by an energized biasing member within drive assembly 140. A user can wind or introduce energy into the biasing member by rotating or otherwise actuating key shaft 174. As described herein, drive assembly 140 can include a gear assembly to provide a mechanical advantage to the user and / or drive assembly 140.

[0022] As described herein, the drive assembly 140 can be fluidly isolated from the medical fluid passing through the fluid inlet 138 a and the fluid outlet 138 b in the tube 106. As shown, the diaphragm assembly 130 is fluidly coupled to or in fluid communication with the medical fluid via the fluid inlet 138 a and the fluid outlet 138 b, isolating the drive assembly 140 from the medical fluid. Advantageously, the drive assembly 140 can be removably attached to or otherwise selectively coupled to the diaphragm assembly 130 to actuate the diaphragm assembly 130. In certain applications, the drive assembly 140 can be used, removed, and reused with the diaphragm assembly 130. In some applications, the diaphragm assembly 130 can be detached from the tube 106 and discarded after use.

[0023] Figure 3 illustrates the diaphragm assembly 130 of the pumping assembly 120 shown in Figure 1. In the illustrated example, actuation of the diaphragm assembly 130 moves or transfers medical fluid from a fluid inlet 138a to a fluid outlet 138b. As described herein, the diaphragm assembly 130 may be actuated by a drive assembly 140 that is removably attached to the diaphragm assembly 130.

[0024] In the illustrated example, a diaphragm 134 coupled to the housing 132 defines a volume 133 in fluid communication with a fluid inlet 138a and a fluid outlet 138b (shown in FIG. 7). During operation, movement or deflection of the diaphragm 134 can change the size of the volume 133 to draw in or expel fluid. The diaphragm 134 may be formed from a suitable material, such as an elastically deformable, resilient, or otherwise elastomeric material. In some embodiments, the diaphragm 134 may be overmolded onto the housing 132. Additionally, in some embodiments, the diaphragm 134 may be press-fit into the housing 132.

[0025] In operation, the diaphragm 134 is pulled or stretched away from the housing 132, expanding the volume 133 of the diaphragm assembly 130 and creating a pressure drop that can aspirate or draw medical fluid from the fluid inlet 138a into the volume 133. In some embodiments, the diaphragm assembly 130 (or other portion of the IV set) can include a one-way valve to prevent backflow of fluid from the fluid outlet 138b during the expansion of the volume 133.

[0026] Additionally, diaphragm 134 can be contracted or compressed into housing 132 to contract or reduce volume 133 of diaphragm assembly 130, compressing the medical fluid within volume 133 and expelling the medical fluid from volume 133 to fluid outlet 138b and toward the patient. Diaphragm assembly 130 (or other portions of the IV set) can include another one-way valve to prevent backflow of fluid from volume 133 to fluid inlet 138a during contraction of volume 133.

[0027] In operation, diaphragm 134 can be deformed or moved manually or by drive assembly 140. As described herein, diaphragm 134 can be actuated to be moved or deformed by piston rod 150 of drive assembly 140. As described herein, an end of piston rod 150 can be removably coupled to port 136 of diaphragm 134. Piston rod 150 can engage with snap features in port 136. Additionally, diaphragm 134 can function as a fluid barrier to prevent medical fluids from contacting drive assembly 140 or piston rod 150.

[0028] In some applications, the cyclic expansion and contraction of volume 133 caused by movement of diaphragm 134 can pump fluid from fluid inlet 138a to fluid outlet 138b. As described herein, reciprocating motion of piston rod 150 can actuate diaphragm 134 in a cyclical manner to pump fluid to a patient. Advantageously, the configuration of pumping assembly 120 allows for increased flow rates and reduced refill times compared to certain conventional pumps. For example, embodiments of pumping assembly 120 can allow for flow rates of up to 30 L / min.

[0029] FIG. 4 is an exploded view of drive assembly 140 of pumping assembly 120 of FIG. 2. Referring to FIG. 4, drive assembly 140 reciprocates piston rod 150 to actuate diaphragm assembly 130 and pump fluid to a patient. During operation, piston rod 150 can reciprocate at a desired stroke length and frequency to actuate diaphragm assembly 130 and provide a desired fluid flow rate. An end 158 of piston rod 150 (shown in FIG. 5) can be coupled to diaphragm 134 via a port 136 defined in diaphragm 134. A shoulder 156 of piston rod 150 can abut diaphragm 134.

[0030] In the illustrated example, the profile 162 of the crank 160 defines the movement or translation of the piston rod 150. One or more followers 152, 154 coupled to and extending from the piston rod 150 can follow the exterior profile 162 of the crank 160 to translate the piston rod 150 as the crank 160 rotates. The exterior profile 162 of the crank 160 can include one or more curved lobes 164. As shown, the exterior profile 162 can have a multi-lobe 164 configuration. In some embodiments, the exterior profile 162 of the crank 160 can define five lobes 164. The followers 152, 154 can have a generally cylindrical shape to engage or follow the exterior profile 162 of the crank 160, creating a cam and follower configuration.

[0031] In operation, rotation of the crank 160 translates or moves the piston rod 150. As shown, the front follower 152 engages or follows the front surface of the outer profile 162 to advance the piston rod 150 forward toward the diaphragm assembly 130 (toward a compressed or ejected position) based on the geometry of the crank 160. Similarly, the rear follower 154 engages or follows the rear surface of the outer profile 162 to retract the piston rod 150 away from the diaphragm assembly 130 (toward an extended or suction position) based on the geometry of the crank 160. As shown, the front follower 152 and the rear follower 154, together with the outer profile 162 of the crank 160, can enable the piston rod 150 to reciprocate based on the geometry of the outer profile of the crank 160. Thus, the outer profile 162 of the crank 160 can define the pumping action of the diaphragm assembly 130.

[0032] In some embodiments, crank 160 can be passively rotated by drive mechanism 170 (described below and shown in FIG. 5 ) or manually rotated by a clinician via handle 166. As described below, drive mechanism 170 can be energized by rotating or winding keyed shaft 174. Winding or rotating keyed shaft 174 can energize a spring or biasing member configured to release energy and rotate crank 160. Advantageously, the configuration of drive assembly 140 allows a clinician to easily operate pumping assembly 120 with relatively low force (e.g., 0.2 Nm) and low fatigue compared to certain conventional pumps.

[0033] As shown, the components of drive assembly 140 may be disposed within or attached to housing 142. In some embodiments, piston rod 150 and crank 160 are coupled to housing 142, with portions of drive mechanism 170 disposed within housing 142. Additionally, as described herein, housing 142 may include features for removably attaching drive assembly 140 to diaphragm assembly 130. For example, housing 142 may include tabs or fingers 146 disposed about piston rod 150 configured to engage diaphragm housing 132 to removably couple drive assembly 140 with diaphragm assembly 130.

[0034] In some embodiments, the drive assembly 140 may be coupled to an IV pole 143. As shown, the housing 142 may be removably coupled to a mounting plate 144 that is attached to the IV pole 143. The housing 142 may be attached to the mounting plate 144 by a "snap fit" clip or an interference fit attachment.

[0035] Figure 5 is a partial cross-sectional view of drive assembly 140 of Figure 4. Figure 6 is a detailed view of drive mechanism 170 of drive assembly 140 of Figure 4. As explained above, in some embodiments, crank 160 can be rotated by drive mechanism 170 to enable passive operation of pumping assembly 120.

[0036] In the illustrated example, energy for driving crank 160 may be stored in biasing member 172. Biasing member 172 may be a spring, such as a torsion spring, or any other suitable device for selectively storing and releasing energy. Energy may be introduced into biasing member 172 by a user. A user may rotate key shaft 174 to wind or otherwise energize biasing member 172. The energy stored in biasing member 172 may be selectively released to rotate crank 160.

[0037] In some embodiments, drive mechanism 170 includes one or more intermeshed gears 176 a, 176 b, 176 c. Gears 176 a, 176 b, 176 c can provide a mechanical advantage to a user winding key shaft 174 to energize biasing member 172. Additionally, gears 176 a, 176 b, 176 c can control the release or discharge of energy from biasing member 172 to crank 160.

[0038] Advantageously, drive mechanism 170 can reduce the amount of fatigue experienced by a user compared to certain conventional pumps by reducing the amount of prolonged manual input required to operate pumping assembly 120. In some applications, drive mechanism 170 can provide enough energy for 20 actuations of diaphragm assembly 130 (i.e., to transfer approximately 152 mL). In some embodiments, drive mechanism 170 can reduce the amount of torque (0.2 Nm) required to operate pumping assembly 120 compared to certain conventional pumps. Furthermore, in some embodiments, pumping assembly 120 can enable a significantly higher passive flow rate (e.g., 515 mL / min compared to 300 mL / min) than certain conventional pumps.

[0039] Figure 7 is a detailed view of the interface between drive assembly 140 and diaphragm assembly 130. Figure 8 is a detailed view of the attached drive assembly 140 and diaphragm assembly 130. As described herein, drive assembly 140 and diaphragm assembly 130 can include features to allow these components to be removably attached. Advantageously, because drive assembly 140 is fluidly isolated from the medical fluid, drive assembly 140 can be removed from diaphragm assembly 130 after use, allowing drive assembly 140 to be reused and diaphragm assembly 140 deployed.

[0040] As shown, resilient fingers 146 extending from housing 142 of drive assembly 140 can engage windows 135 defined in diaphragm housing 132 of diaphragm assembly 130. Windows 135 can be circumferentially disposed around diaphragm 134. Resilient fingers 146 can be biased outward to engage edges of windows 135 to couple drive assembly 140 with diaphragm assembly 130. Drive assembly 140 can be removed from diaphragm assembly 130 by depressing fingers 146 inward.

[0041] FIG. 9 is a detailed view of the piston rod 150 of the drive assembly 140 and the diaphragm 134 of the diaphragm assembly 130. Referring to FIGS. 7-9 , in addition to the removably attached housings 132, 142 of the diaphragm assembly 130 and the drive assembly 140, respectively, the piston rod 150 may be removably attached to the diaphragm 134. As shown, a groove 159 in the piston rod end 158 may engage a feature 137 in the port 136 of the diaphragm 134 to removably couple the piston rod 150 to the diaphragm 134. In some embodiments, the piston rod end 158 may have an annular “snap fit” or interference fit with the port 136 of the diaphragm 134 to enable the piston rod 150 to actuate the diaphragm 134. As shown, a shoulder 156 of the piston rod 150 may abut a portion of the diaphragm 134. In some embodiments, the contact angle between the groove 159 of the piston rod 150 and the feature 137 of the port 136 can be adjusted to enable a desired retention force. Advantageously, the retention force between the groove 159 and the feature 137 can be configured based on the actuation force of the piston rod 150 against the diaphragm 134 to prevent inadvertent removal of the piston rod 150 from the diaphragm 134 during operation, while allowing intentional removal by a user.

[0042] Examples of subject matter art as clauses The subject technology is presented according to various aspects, for example, as described below. Various examples of aspects of the subject technology are described as numbered clauses (1, 2, 3, etc.) for convenience. These are provided as examples and are not intended to limit the subject technology. Note that any of the dependent clauses may be combined in any combination and placed into a respective independent clause, e.g., clause 1 or clause 5. Other clauses may be presented similarly.

[0043] Clause 1. A pump assembly for use with an IV set, comprising: 1. A pump assembly comprising: a rotatable crank having a crank profile, the crank profile defining a plurality of lobes; a piston rod having a first follower and a second follower spaced from the first follower, the first follower contacting the crank profile to selectively advance the piston rod and the second follower contacting the crank profile to selectively retract the piston rod, wherein rotation of the crank relative to the piston rod reciprocates the piston rod relative to the crank; and a diaphragm assembly comprising: a housing; and a resilient diaphragm member coupled to the housing and cooperatively defining a volume in fluid communication with an IV set, the diaphragm member movable between an extended position configured to increase the volume and draw fluid from the IV set and a retracted position configured to decrease the volume and expel fluid into the IV set, the diaphragm being coupled to the piston rod to reciprocate the diaphragm member between the extended and retracted positions.

[0044] Clause 2. The pump assembly of clause 1, further comprising a biasing member coupled to the crank and configured to rotate the crank.

[0045] Clause 3. The pump assembly of clause 2, further comprising a key shaft coupled to the biasing member, the key shaft being rotatable to impart energy to the biasing member.

[0046] Clause 4. The pump assembly of clause 2, comprising a plurality of gears coupled to the biasing member and the crank.

[0047] Clause 5. The pump assembly of clause 1, wherein the crank is manually rotatable.

[0048] Clause 6. The pump assembly of clause 1, wherein the diaphragm member is removably coupled to the piston rod.

[0049] Clause 7. The pump assembly of clause 1, further comprising a check valve in fluid communication with the volume to prevent backflow of fluid into the volume.

[0050] Clause 8. A pump assembly for use with an IV set, comprising: a drive assembly housing having a plurality of tabs; a drive assembly including a piston rod having an end extending through the drive assembly housing between the plurality of tabs and a drive mechanism configured to reciprocate the piston rod; 1. A pump assembly comprising: a diaphragm assembly configured to be removably coupled to a drive assembly, the diaphragm assembly comprising: a diaphragm housing including a plurality of windows configured to removably engage a plurality of tabs on the drive assembly housing; and a resilient diaphragm member coupled to the housing and cooperatively defining a volume in fluid communication with the IV set, the diaphragm member being movable between an extended position configured to increase the volume and draw fluid from the IV set and a retracted position configured to decrease the volume and expel fluid into the IV set, the diaphragm being removably coupled to a piston rod for reciprocating the diaphragm member between the extended and retracted positions.

[0051] Clause 9. The pump assembly of clause 8, further comprising a biasing member configured to energize the drive mechanism.

[0052] Clause 10. The pump assembly of clause 9, further comprising a key shaft coupled to the biasing member, the key shaft being rotatable to impart energy to the biasing member.

[0053] Clause 11. The pump assembly of clause 9, comprising a plurality of gears coupled to the biasing member and the drive mechanism.

[0054] Clause 12. The pump assembly of clause 8, further comprising a check valve in fluid communication with the volume to prevent backflow of fluid into the volume.

[0055] Clause 13. The pump assembly of clause 8, wherein the drive mechanism comprises a rotatable crank configured to engage the piston rod.

[0056] Clause 14. A pump assembly as described in clause 13, wherein the piston rod comprises a follower that is to contact the crank.

[0057] Clause 15. The pump assembly of clause 13, wherein the crank is manually rotatable.

[0058] Clause 16. A pump assembly for use with an IV set, the pump assembly comprising: a rotatable crank having a crank profile; a piston rod having first and second followers, each in contact with the crank profile, wherein rotation of the crank relative to the piston rod reciprocates the piston rod relative to the crank; a biasing member coupled to the crank and configured to rotate the crank; a keyed shaft coupled to the biasing member, the keyed shaft being rotatable to impart energy to the biasing member; and a diaphragm assembly comprising: a housing; and a resilient diaphragm member coupled to the housing and cooperatively defining a volume in fluid communication with the IV set, the diaphragm member being movable between an extended position configured to draw fluid from the IV set and a retracted position configured to expel fluid to the IV set, the diaphragm being coupled to the piston rod to reciprocate the diaphragm member between the extended and retracted positions.

[0059] Clause 17. The pump assembly of clause 16, comprising a plurality of gears coupled to the biasing member and the crank.

[0060] Clause 18. The pump assembly of clause 16, wherein the crank is manually rotatable.

[0061] Clause 19. The pump assembly of clause 16, wherein the diaphragm member is removably coupled to the piston rod.

[0062] Clause 20. The pump assembly of clause 16, further comprising a check valve in fluid communication with the volume to prevent backflow of fluid into the volume.

[0063] This disclosure is provided to enable those skilled in the art to practice the various aspects described herein. This disclosure provides various examples of the subject technology, and the subject technology is not limited to these examples. Various modifications to these aspects will be readily apparent to those skilled in the art, and the generic principles defined herein may be applied to other aspects.

[0064] Reference to an element in the singular is intended to mean "one or more" rather than "one and only one" unless otherwise specified. The term "some" refers to one or more unless otherwise specified. Masculine pronouns (e.g., his) include feminine and neuter (e.g., her and its) and vice versa. Headings and subheadings, if any, are used for convenience only and are not intended to limit the invention.

[0065] The word "exemplary" is used herein to mean "serving as an example or illustration." Any aspect or design described herein as "exemplary" is not necessarily to be construed as preferred or useful over other aspects or designs. In one aspect, various alternative configurations and operations described herein may be considered at least equivalent.

[0066] The use of a phrase such as "aspect" does not imply that such aspect is essential to the subject technology or that such aspect applies to all configurations of the subject technology. Disclosure regarding an aspect may apply to all configurations, or to one or more configurations. An aspect may provide one or more examples. A phrase such as an aspect may refer to one or more aspects, and vice versa. A phrase such as "embodiment" does not imply that such an embodiment is essential to the subject technology or that such an embodiment applies to all configurations of the subject technology. Disclosure regarding an embodiment may apply to all embodiments, or to one or more embodiments. An embodiment may provide one or more examples. A phrase such as an embodiment may refer to one or more embodiments, and vice versa. A phrase such as "configuration" does not imply that such configuration is essential to the subject technology or that such configuration applies to all configurations of the subject technology. Disclosure regarding a configuration may apply to all configurations, or to one or more configurations. A configuration may provide one or more examples. A phrase such as "configuration" may refer to one or more configurations, and vice versa.

[0067] In one aspect, unless otherwise specified, all measurements, values, ratings, positions, dimensions, sizes, and other specifications set forth in this specification, including the claims that follow, are approximate and not exact, and are intended to have a reasonable range consistent with the function to which they relate and that which is customary in the art to which they pertain.

[0068] In one aspect, the term "coupled" or the like can refer to being directly coupled. In another aspect, the term "coupled" or the like can refer to being indirectly coupled.

[0069] Terms such as "upper," "lower," "front," and "rear," as used in this disclosure, should be understood to refer to any frame of reference other than the usual frame of reference of gravity. As such, upper, lower, front, and rear surfaces may extend upward, downward, diagonally, or horizontally in the frame of reference of gravity.

[0070] Various items may be arranged differently (e.g., placed in a different order or partitioned in another way) without departing from the scope of the subject technology. All structural and functional equivalents to the elements of the various aspects described throughout this disclosure that are known or later become known to those of ordinary skill in the art are expressly incorporated herein by reference and are intended to be encompassed by the claims. Furthermore, nothing disclosed herein is intended to be exclusive to the public, regardless of whether such disclosure is expressly recited in the claims. No element of a claim is to be construed under the provisions of 35 U.S.C. 112, sixth paragraph, unless the element is expressly recited using the phrase "means for," or, in the case of a method claim, the element is recited using the phrase "step for." Furthermore, to the extent terms such as "comprising," "having," and the like are used, such terms are intended to be inclusive in the same manner as the term "comprising" is interpreted when used as a transitional term in a claim.

[0071] The title, background, summary, brief description of the drawings, and abstract of this disclosure are hereby incorporated into this disclosure and are provided as illustrative examples of the disclosure, not as a limiting description. It is submitted with the understanding that they will not be used to limit the scope or meaning of the claims. Additionally, in the Detailed Description, it will be appreciated that the description provides illustrative examples and that various features are grouped together in various embodiments for the purpose of streamlining the disclosure. This method of disclosure is not to be interpreted as reflecting an intention that the claimed subject matter requires more features than are expressly recited in each claim. Rather, as the following claims reflect, inventive subject matter lies in less than all features of a single disclosed structure or operation. The following claims are hereby incorporated into the Detailed Description, with each claim standing on its own as separately claimed subject matter.

[0072] The claims are not intended to be limited to the embodiments described herein, but are to be accorded the full scope consistent with the language of the claims and encompass all legal equivalents. Nevertheless, none of the claims are intended to, and should not be construed to, encompass subject matter that does not satisfy the requirements of 35 U.S.C. §§ 101, 102, or 103.

Claims

1. 1. A pump assembly for use with an IV set, said pump assembly comprising: a rotatable crank comprising a crank profile, the crank profile defining a plurality of lobes; a piston rod comprising a first follower and a second follower spaced from the first follower, the first follower contacting the crank profile to selectively advance the piston rod and the second follower contacting the crank profile to selectively retract the piston rod, and rotation of the crank relative to the piston rod causes the piston rod to reciprocate relative to the crank; 1. A diaphragm assembly comprising: Housing and a resilient diaphragm member coupled to the housing and cooperatively defining a volume in fluid communication with the IV set, the diaphragm member movable between an extended position configured to increase the volume and draw fluid from the IV set and a retracted position configured to decrease the volume and expel fluid into the IV set, the diaphragm member coupled to the piston rod for reciprocating the diaphragm member between the extended and retracted positions; a diaphragm assembly comprising: A pump assembly comprising:

2. The pump assembly of claim 1 , further comprising a biasing member coupled to the crank and configured to rotate the crank.

3. The pump assembly of claim 2 , further comprising a key shaft coupled to the biasing member, the key shaft being rotatable to impart energy to the biasing member.

4. The pump assembly of claim 2 , comprising a plurality of gears coupled to the biasing member and the crank.

5. The pump assembly of claim 1 , wherein the crank is manually rotatable.

6. The pump assembly of claim 1 , wherein the diaphragm member is removably coupled to the piston rod.

7. The pump assembly of claim 1 , further comprising a check valve in fluid communication with the volume to prevent backflow of fluid into the volume.

8. 1. A pump assembly for use with an IV set, said pump assembly comprising: a drive assembly housing having a plurality of tabs; a piston rod having an end extending through the drive assembly housing between the plurality of tabs; a drive mechanism configured to reciprocate the piston rod; a drive assembly comprising: a diaphragm assembly configured to be removably coupled to the drive assembly, the diaphragm assembly comprising: a diaphragm housing including a plurality of windows configured to removably engage the plurality of tabs on the drive assembly housing; a resilient diaphragm member coupled to the housing and cooperatively defining a volume in fluid communication with the IV set, the diaphragm member movable between an extended position configured to increase the volume and draw fluid from the IV set and a retracted position configured to decrease the volume and expel fluid into the IV set, the diaphragm being removably coupled to the piston rod for reciprocating the diaphragm member between the extended and retracted positions; a diaphragm assembly comprising: A pump assembly comprising:

9. The pump assembly of claim 8 , further comprising a biasing member configured to energize the drive mechanism.

10. The pump assembly of claim 9 , further comprising a keyed shaft coupled to the biasing member, the keyed shaft being rotatable to impart energy to the biasing member.

11. The pump assembly of claim 9 comprising a plurality of gears coupled to the biasing member and the drive mechanism.

12. The pump assembly of claim 8 , further comprising a check valve in fluid communication with the volume to prevent backflow of fluid into the volume.

13. The pump assembly of claim 8 , wherein the drive mechanism comprises a rotatable crank configured to engage the piston rod.

14. 14. The pump assembly of claim 13, wherein the piston rod includes a follower portion adapted to contact the crank.

15. The pump assembly of claim 13 , wherein the crank is manually rotatable.

16. 1. A pump assembly for use with an IV set, said pump assembly comprising: a rotatable crank having a crank profile; a piston rod including first and second follower portions each in contact with the crank profile, wherein rotation of the crank relative to the piston rod causes the piston rod to reciprocate relative to the crank; a biasing member coupled to the crank and configured to rotate the crank; a key shaft coupled to the biasing member, the key shaft being rotatable to impart energy to the biasing member; 1. A diaphragm assembly comprising: Housing and a resilient diaphragm member coupled to the housing and cooperatively defining a volume in fluid communication with the IV set, the diaphragm member movable between an extended position configured to draw fluid from the IV set and a retracted position configured to expel fluid into the IV set, the diaphragm member coupled to the piston rod for reciprocating the diaphragm member between the extended and retracted positions; a diaphragm assembly comprising: A pump assembly comprising:

17. The pump assembly of claim 16, comprising a plurality of gears coupled to the biasing member and the crank.

18. 17. The pump assembly of claim 16, wherein the crank is manually rotatable.

19. The pump assembly of claim 16, wherein the diaphragm member is removably coupled to the piston rod.

20. 17. The pump assembly of claim 16, further comprising a check valve in fluid communication with the volume to prevent backflow of fluid into the volume.

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