Delivery device

Abstract

To provide a delivery device that can be used to administer microparticles to a patient intravenously at a low speed and / or at a constant rate during the operation.SOLUTION: A delivery device includes a first fluid inlet fluidly connectable to a first source of an injection medium, a fluid outlet, a fluid mixer fluidly connecting the first fluid inlet to the fluid outlet, a second fluid inlet fluidly connectable to a second source of the injection medium, and a source of microparticles fluidly connecting the second fluid inlet to the fluid mixer. When fluid flows from the second source of the injection medium into the delivery device, a second injection medium fluidly drives microparticles from the source of microparticles into the fluid mixer, and the fluid outlet dispenses to the patient an injection medium that includes the microparticles.SELECTED DRAWING: Figure 1

Description

[Technical field]

[0001] CROSS-REFERENCE TO RELATED APPLICATIONS This application is a continuation of U.S. Provisional Patent Application No. 62 / 749,322, filed October 23, 2018. No. 2, and U.S. Provisional Patent Application No. 62 / 754,355, filed November 1, 2018. No. 6,393,633, filed on Dec. 13, 2003, which claims the benefit of priority to the same patent application as claim 1, which are incorporated herein by reference.

[0002] The present disclosure relates to a device for delivering microparticles to a patient. [Background technology]

[0003] The following paragraphs are provided to those of skill in the art to indicate that the material discussed therein is prior art or that This document does not constitute an admission that the information contained herein is part of the general knowledge of the

[0004] The microparticles can be used to treat hypervascular tumors, such as uterine leiomyomas, and blood vessels, such as vascular malformations. For selective occlusion of blood vessels in the treatment of abnormalities, interventional radiology (IRA) These microparticles are injected into the hepatic artery of a patient.

[0005] Selective internal radiation therapy (SIRT) is used to treat primary or metastatic hepatic malignancies. In SIRT, yttrium 90 ( 90 Y) Radioactively labeled microparticles enter the patient's hepatic artery Radioactive yttrium - preferentially localizes to liver tumors due to increased vascularization. The 90-labeled microparticles disintegrate and irradiate the surrounding tissue.

[0006] preface The following preamble is intended to introduce the reader to the present specification, but does not define the invention. One or more inventions are directed to the apparatus features described below or elsewhere in this document. The present invention may be implemented in any combination or subcombination of any element or method step. By simply not claiming one or more inventions, No waiver or disclaimer of rights to the inventions presented.

[0007] The microparticles are injected intravenously into a patient using an infusion medium such as an intravenous aqueous solution. However, if the particles have a density substantially higher than the injection medium (glass particles in an aqueous solution), etc.), the particles may settle out together, making it difficult to inject the particles into a patient. Administering a slow and consistent rate can be particularly difficult.

[0008] BTG allows the injection medium to flow upward through the bottom of the settled particulates to fill a constant volume reservoir. TheraSphere( The company attempts to address this problem with its Yttrium-90 glass particulate product. The activated microparticles are delivered to the patient along with the infusion medium. To fluidize particles that are significantly denser than glass particles in saline, This approach may require undesirably high flow rates of injection medium, which is related to the density of the microparticles. This can result in an infusion medium with inconsistent concentrations of delivered microparticles over time. Fluidization of particles is achieved by treating microparticles that are significantly denser than the injection medium and when the concentration of microparticles is greater than that of the injection medium. Consistently for microparticles in close proximity to the body (e.g., resin-based microparticles in saline solution). This may result in administration of ineffective concentrations. Summary of the Invention [Problem to be solved by the invention]

[0009] Thus, during operation, the microparticles are administered intravenously to the patient at a slow and / or constant rate. There remains a need for a delivery device that can be used for [Means for solving the problem]

[0010] In one aspect, the present disclosure provides a method for producing a microfluidic device comprising: a first fluid inlet; a second fluid inlet; a fluid mixer; a fluid mixer for mixing the particulates with the fluid from the source and a fluid outlet; The fluid mixer is fluidly connected to a source of injection fluid through the first fluid inlet. The source of particulates is fluidly connectable to the first fluid source of the body. The fluid mixer is fluidly connectable to a second source of infusion medium via a port. The fluid outlet is fluidly connected to the fluid port for transport of an input medium.

[0011] In another aspect, the present disclosure provides a method for delivering microparticles to a patient. The method includes: The injection medium is flowed into a first arm of the fluid mixer, and then into a second arm of the fluid mixer. and directing a second infusion medium into a third arm of the fluid mixer. and introducing the second infusion medium into the elongated housing. Fluidically driving the microparticles into a first injection medium, and forming the resulting microparticles into the first injection medium. and administering intravenously to the patient a mixture of said first infusion medium and said second infusion medium. The flow of infusion medium is independent of the flow of the second infusion medium.

[0012] Embodiments of the present disclosure will now be described, by way of example only, with reference to the accompanying drawings, in which: [Brief description of the drawings]

[0013] [Figure 1] FIG. 1 is an illustration of an exemplary transport device according to the present disclosure. [Diagram 2] FIG. 2 is a cross-sectional view of an exemplary fluid mixer that may be used in a transport device according to the present disclosure. [Diagram 3] FIG. 3 is a cross-sectional view of a portion of an exemplary transport device oriented in a load direction. [Figure 4] FIG. 4 is a cross-sectional view of a portion of an exemplary transport device oriented in a fluid-filling orientation. [Diagram 5] FIG. 5 is a side view of another example of a transport device according to the present disclosure. [Figure 6] FIG. 6 is a side view of a portion of the transport device of FIG. 5, with portions shown as transparent to show internal details. [Figure 7] FIG. 7 is a side view of the delivery device of FIG. 5 with the chamber separated from the remainder of the delivery device. [Figure 8] FIG. 8 is a side view of an example of a fluid mixer of the transport device of FIG. [Figure 9] FIG. 9 is a side view of yet another example of a transport device according to the present disclosure. DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENTS

[0014] In general, the present disclosure provides a fluid inlet, a second fluid inlet, a fluid mixer, a source of particulates, and a method for producing a fluid inlet and a method for producing a particulate. The fluid mixer is adapted to deliver a fluid to a source of particulates, and a fluid outlet. and via a first fluid inlet, a first supply of infusion medium, referred to as a transfer medium The source of particulates is fluidly connectable to the displacement medium via the second fluid inlet. The fluid mixer is fluidly connectable to a second source of infusion medium, referred to as an intravenous catheter. A fluid outlet is provided for delivering a transfer medium and a replacement medium to a patient or the like via the catheter. is connected to

[0015] During operation, fluid driven from a source of displacement medium into the transport device flows from a source of particulates. The particulates are fluidly driven into the mixer.

[0016] The first and second fluid inlets are adapted to allow the flow of the transfer medium and the displacement medium through the fluid mixer. , allowing them to be independent of each other.

[0017] In the context of this disclosure, a "fluid mixer" refers to a mixer in which both the transport medium and the displacement medium are fluid. Refers to any combination of components that mix the transport medium with the replacement medium as it flows into the mouth When the particulate source is filled with particulates, the displacement medium is Carry at least some of the particulates.

[0018] For example, a fluid mixer may be a T-junction, such as a chromatography T-junction. In one example, the fluid mixer may be a junction or a Y-junction. and a conduit for fluidly connecting a source of transport medium to the fluid outlet. The fluid mixer may also be used to add particulates to the transport medium passing through the fluid mixer. The dispenser may include a dispenser disposed within the conduit. In a particular embodiment, the fluid mixer is configured with two concentric tubes. (a) an outer tube that conveys the transfer medium from a source of the transfer medium to a fluid outlet; and (b) conveying the particulates from a source of the particulates to the transport medium in the direction of flow of the transport medium. an inner tube.

[0019] The source of particulates may be an elongated housing, such as tubing, that holds or contains the particulates. The elongated housing for holding the particulates may include a fluid mixer at one end. and is fluidly connectable at a distal end to a source of replacement medium. Fluid is driven from a source into the distal end of the elongated housing. The particulates are fluidly driven from the elongated housing into a fluid mixer.

[0020] In some examples, the dispenser in the fluid mixer is configured such that the transport device is oriented in the transport direction. In another example, the fluid mixer may have a portion that is substantially horizontally disposed when the fluid mixer is inserted. The spacer has a portion that is disposed substantially vertically when the transport device is oriented in the transport direction. possible.

[0021] In the exemplary dispenser, the cross-sectional area of ​​the flow path for the particles is large enough, and Since the flow is sufficiently constant, the fluid flow is controlled by the specified operating flow rate and the particles are transported. For example, the diameter of the flow passage of the microparticles may be substantially smaller than the average diameter of the microparticles administered. and / or the elongated housing containing the particulates may be at least three times the diameter of the particulates. The cross-sectional area may be the same as the opening of the fluid mixer for injection of the child. , and the cross-sectional area of ​​the flow path of the particulate is "sufficiently constant" compared to the flow rate of the displacement medium. To account for the increased flow rate of the combined transport medium and displacement medium, a fluid mixer is used. It should be understood that the flow rate is smaller before the flow mixer and larger after the flow mixer.

[0022] Exemplary Dispenser Including a Particulate Dispenser with a Fluid Mixer Disposed Within a Conduit In this case, the cross section of the conduit does not substantially restrict the flow of fluid (at the operating flow rate) through the fluid mixer. The cross section of the dispenser may be large enough so that the

[0023] In operation, the transport device is fluidly connected to a transport medium and a displacement medium. The transport medium flows from a source through the fluid mixer and is transported through a fluid outlet. The fluid may be administered to the patient intravenously, for example via a catheter. In the absence of However, when the source of replacement medium flows into the delivery device, the particulates are transferred from the particulate source to the delivery device. The fluid mixer is driven fluidly into the transport medium passing therethrough, and the transport medium and the displacement medium are mixed. The mixture is carried through a fluid outlet for delivery to the patient.

[0024] For a given flow rate of the transport medium, the amount of particulate delivered to the patient depends on the flow rate of the replacement medium. A higher flow rate transports more particles per unit time into the fluid. The lower the flow rate, the higher the dosage of the microparticles. This results in fewer particles being forced into the fluid mixer per unit time, This results in a lower dose for the child.

[0025] The flow rates of the first and second infusion media are both selected and combined to reduce the amount of particulate matter. A desired transport rate can be provided, but the flow of the transport medium is independent of the flow of the replacement medium. .

[0026] The flow rate of the transport medium is 2 to 80 times, for example, 10 to 50 times or 20 to 40 times, that of the replacement medium. The combined flow rate of the transfer medium and the replacement medium can be up to about 0.5 mL / s. The flow rate may be substantially the same as the flow rate of the patient's blood flow, such as a flow rate of 100 μm. The packing efficiency within the housing may be about 80% to about 40%. The volume of the microparticles relative to the total volume of the injection device. providing about 1 mg to about 200 mg of microparticles per combined volume of the first and second infusion media; The particulate may have a specific gravity greater than the specific gravity of the transport medium. may have a specific gravity with respect to water of about 3.3 to about 3.9.

[0027] A transport device is also fluidly connected to the elongated housing and in position with the elongated housing. A chamber may be defined that is fluidly disposed between the exchange medium and the sized to retain at least all of the particulates within the transport device, and The chamber may be used to load particles into the elongated housing. When oriented in the loading direction, for example, the chamber is positioned substantially above the elongated housing. may include a conical portion that funnels particulates from the chamber into the elongated housing when the The transport device is oriented such that the elongated housing is disposed substantially above the chamber. When oriented in the fluid-filling direction, the particles remain within the chamber.

[0028] To fill the elongated housing with particulates, a transport device is arranged in the fluid filling direction. Qualitatively all of the particles are dropped into a chamber located substantially below the elongated housing. If the elongated housing is not filled with a fill fluid, the transport device may be filled with a displacing medium. The elongated housing may be connected to such a fluid source, and the elongated housing is fluidly connected to the chamber. The elongated halves can be filled from their bottom ends, which are connected to the fluid mixer, to their top ends, which are connected to the fluid mixer. Once the housing is filled with fill fluid, the transport device can be positioned in a fill orientation. The particulates disposed in the chamber may be disposed in an elongated housing that may be disposed substantially below the chamber. The particles, which are denser than the filling fluid, are poured in. The particles, which are denser than the filling fluid, are poured in. They settle and fill the elongated housing faster than fine particles.

[0029] In the context of this disclosure, "substantially above" and "substantially below" refer to how the fluid For example, if an elongated housing has a length of 45 mm, If the chamber is tilted at an angle of 100 degrees and the chamber is not directly below the elongated housing, the particles will The chamber may fall from the housing into the chamber. For example, the chamber may fall directly above the housing. However, the funnel is angled sufficiently to direct the particles into the elongated housing. In this case, the particulates may fall out of the chamber and into the elongated housing.

[0030] When the particulate source includes an elongated housing, the transport device may include a fluid mixer that is connected to the elongated housing. The housing may include a particulate trap fluidly connected to the housing. In the filling direction, the particulates may be elongated. The fluid is poured into the housing and a particulate trap prevents particulates from entering the fluid mixer. The trap may be, for example, a tube that connects the elongated housing to a fluid mixer. The bending motion may be approximately a 90 degree bend or a U-turn within the working.

[0031] The transport device may alternatively be fluidly connected to the elongated housing. A chamber that is not fluidly disposed between the ring and the replacement medium can be defined. The chamber is adapted to retain at least all of the particulate matter loaded within the elongated housing. The chamber is sized to be fluidly external to the fluid flow path from the displacement medium to the liquid outlet. To fill the elongated housing with particulates, the particulates in the chamber may be From the chamber, optionally through a fluid mixer, and into the elongated housing. The microparticles are forced to flow fill fluid from the chamber through the elongated housing and into the fill fluid. The particles can be transported by being discharged from the fluid outlet. A filter is disposed between the elongated housing and the fill fluid outlet to prevent or inhibit It can be done.

[0032] The filler fluid and particulates can be removed by depressurizing the filler fluid outlet, for example, using a suction syringe. Alternatively, the filler fluid and particulates may be drawn out of the chamber by the displacement fluid. It may be drawn from the chamber by applying a vacuum to the source.

[0033] The filler fluid and particulates may be added to the chamber by, for example, injecting a gas or filler fluid into the chamber. The chamber is then opened by applying positive pressure to the bar and displacing the particles into the elongated housing. Can be pushed off the bar.

[0034] The present disclosure also generally provides devices in which particulates can be loaded. Such devices include a first fluid inlet, a second fluid inlet, a fluid mixer, and a receptacle configured to hold particulates; The fluid mixer includes a receptacle, a fluid outlet, and a fluid mixer fluidly connected to the receptacle. A first fluid inlet is fluidly connectable to a first source of infusion medium, referred to as a transfer medium. The receptacle is adapted to receive a first fluid inlet of the infusion medium, referred to as the replacement medium. The fluid mixer is fluidly connectable to a fluid source of 2. The fluid mixer is fluidly connected to a fluid outlet. .

[0035] If the receptacle holds the particles, the device is called a transport device, and the receptacle As mentioned above, the receptacle is a device for holding particles. or may include an elongated housing, such as tubing, configured to contain the A receptacle, such as an elongated housing, is adapted to fluidly couple at a first end to a source of replacement medium. and at a second end thereof, the fluid mixer. It is possible.

[0036] The device may further include a fill fluid inlet fluidly connected to the receptacle. The supply may be fluidly connectable to the receptacle via the fill fluid inlet. may be provided within the chamber. A supply of microparticles may be provided separately from the device. , a fill fluid outlet, where the receptacle may include a fluid between the fill inlet and the fill fluid outlet. For example, the first end of the receptacle is fluidly connected to the fill fluid outlet. and a second end of the receptacle may be connected to the fluid mixer and to the fill fluid inlet. In another example, the first end of the receptacle can be fluidly connected to the fill fluid inlet. The second end of the receptacle may be connected to a fill fluid outlet, which may be the same as the fluid outlet. The devices may be connected in a timely manner.

[0037] The apparatus may include a filter fluidly disposed between the receptacle and the fill fluid outlet. The filter is designed to trap particles when the receptacle is filled with particles from a particle source. Particles may be prevented or blocked from exiting the fill fluid outlet.

[0038] The transport device further comprises a nozzle for receiving the cleaning medium, the nozzle being fluidly connectable to the fluid outlet through the elongated housing. The cleaning medium may include, for example, a source of microparticles if not all of the microparticles have been administered to the patient. The cleaning medium may be used to wash particulates from the elongated housing. Can be used to prime with the body.

[0039] The present disclosure also generally provides a method for delivering microparticles to a patient. The method includes: A first injection medium, referred to as the body, is flowed into a first arm of the fluid mixer and A second injection medium, called the displacement medium, is pumped out of the second arm of the thermostat and into the fluid mixer. The replacement medium flows into the third arm of the thermostat, where it is pumped through a micro-particle packed in an elongated housing. Fluidically driving the particles into a transport medium and then displacing the resulting microparticles, transport medium, and displacement medium. The flow of the transfer medium is different from the flow of the replacement medium. It is independent.

[0040] The relative flow rate of the transfer medium to the flow rate of the replacement medium determines the concentration of particulates (e.g. Determine the absolute flow rates (e.g., mg / mL) of the transfer and replacement media (e.g., mL / sec). This method determines the amount of microparticles delivered to the patient. g of microparticles can be administered to a patient. In some instances, the method can deliver approximately 1 mg of microparticles per second. From particles to about 60 mg of particulates per second, or from about 1 mg of particulates per second to about 30 mg of particulates per second The particles may be administered to a patient. In a particular example, the method can deliver about 10 mg of microparticles per second. Approximately 20 mg of microparticles can be administered to a patient per second.

[0041] The authors of this disclosure are not limited to any of the exemplary subject matter discussed above, unless the subject matter refers to alternatives. It is to be understood that any and all combinations are contemplated.

[0042] An example of a transport device according to the present disclosure is shown in Figure 1. The transport device (100) comprises a source of transport medium. A first source of infusion medium designated (104) and a source of replacement medium designated (106) are and a fluid outlet (108). The fluid transport device is shown with a fluid mixer (102) connected to it. It should be understood that the product may be manufactured, sold, or delivered without the connections in place. be.

[0043] The delivery device (100) is shown with tubing forming an elongated housing (110). In the illustrated position, the elongated housing (110) has a vertical portion (11 The elongated housing (110) is fluidly coupled at one end to the fluid mixer (102). at the other end, the replacement medium is fluidly connected to a source (106) of replacement medium.

[0044] The transport device (100) comprises an elongated housing (110) and a source (106) of displacement medium. The chamber (114) and the fine particle (116) define a chamber (114) disposed fluidly therebetween. An optional clip (116) is shown between the long housing (110). The clip (116) is disposed between the chamber (114) and the elongated housing (110). It can be used to stop or reduce the flow of fluids and / or particulates.

[0045] In operation, a transport medium from a transport medium source (104) passes through the fluid mixer (102). The replacement medium is delivered from the replacement medium source (106) through a fluid outlet (108). The exchange medium travels through the chamber (114) into the elongated housing (110) and The particulate matter located within the elongated housing (110) is forced into the fluid mixer (102). The transfer medium passing through the fluid mixer (102) is a transfer medium containing fine particles and a displacement medium. The fluid outlet (108) delivers the particles to the patient. 8) is shown as tubing. During transportation, the tubing may be secured by any suitable mechanism. For example, the tubing may be a peripheral tubing that is inserted into the patient. It may be fluidly connected to a venous catheter.

[0046] The ratio of fluid transport from the source of the transfer medium and the source of the replacement medium is at least partially In the illustrated delivery device (100), the delivery The source of medium (104) and the source of replacement medium (106) are syringes connected together. As shown, the two plungers in the two syringes experience the same linear displacement. By combining two syringes in this way, the ratio of the cross-sectional areas of the two syringes is The ratio of fluid delivery can be set by this. The first syringe is a 20 mL syringe. and the second syringe may be a 0.5 mL syringe, and the two syringes may be By connecting such syringes together, a 40:1 The ratio of the fluid transport of the transfer medium to the displacement medium, v / v, is obtained.

[0047] The source of transfer medium (104) and the source of replacement medium (106) are shown as syringes. 1, these sources may be any fluid injection device and may be the same or similar. , or different. This also applies to the devices shown in the other figures. For example, the source of the transfer medium is an IV bag connected to a peristaltic pump. and the source of the replacement medium can be a syringe. Both the source of the transfer medium and the source of the replacement medium can be a syringe. The sources of the medium may be sources of the same medium, but are separately connected and independently transported. For example, the transport device can be a single The first set of tubing can be fluidly connected to an IV bag. The second tubing can be connected to a peristaltic pump that feeds the mixer. The set can be connected to a peristaltic pump that pumps fluid into a source of microparticles.

[0048] The transport medium and the replacement medium may be the same or different. For example, the transfer medium may be saline while the replacement medium may be deionized water, or Both the vehicle and the replacement vehicle may be saline.

[0049] The transport device (100) is also shown with an optional T-port valve (118). The T-port valve (118) allows a fluid, such as a transfer medium, to flow from an inlet (120) to a first inlet (122). only into the first injector, only into the second injector, or Allows both injectors to be drawn in simultaneously.

[0050] A fluid mixer (102) is generally shown in FIG. 2, where the arrows indicate the supply and The direction of flow of the transfer medium is shown from a source (not shown) to a fluid outlet (not shown). The dispenser includes a conduit (122) and a dispenser (124) disposed within the conduit. The dispenser (124) adds particulates to the transport medium passing through the fluid mixer, and The dispenser directs the particles in the direction of the flow of the transport medium. This may direct the particles towards the centre of the fluid flow.

[0051] The chamber (114) is shown in cross section in Figure 3. The chamber (114) is conical. In the illustrated position, the conical portion (126) is at the bottom of the chamber. The microparticles are then pumped into the elongated housing (110). The long housing (110), chamber (114), and source of displacement medium (not shown) are ) are at least fluidly connected via metal fittings (128 and 130) The chamber (114) also includes two separate housings (132 and 133). 4) during the fabrication of the transport device. The two parts of the housing can be joined together. A chamber (114) may be formed. An optional clip (116) may be provided to prevent the device from moving or otherwise affecting the movement of the device. The chamber (114) is closed to reduce or prevent particulates from escaping during obtain.

[0052] The transport device (100) and chamber (114) are shown in the loading direction in Figures 1 and 3. The chamber (114) is shown in a fluid-filled orientation in FIG. In the orientation, an elongated housing (110) is positioned above a chamber (114), and The fine particles are collected in the chamber (114). The displacement medium is placed in the chamber (114). The chamber (114) is connected to a fitting (130) that fluidly connects to a source of exchange medium. The added replacement medium fills the chamber (114) and then passes through the elongated housing (116). The displacement medium may be added at a rate that avoids fluidizing the fine particles. This allows the elongated housing (110) to be emptied without introducing a large amount of particulates into the elongated housing (110). The housing (110) may be filled.

[0053] Once the chamber (114) and the elongated housing (110) are filled with fluid, the transport The device can then be returned to the loading position shown in FIG. The particles are then transported through the conical portion (126) of the chamber (114) into the elongated housing. The mixture is poured into a mold (110).

[0054] Reference is now made to Figures 5 through 8, which illustrate another embodiment of a transport device according to the present disclosure. Many of the features of the transport device shown are similar to those described above with reference to Figures 1 to 4. 5. In order to avoid obscuring the description, the above description will not be repeated in detail. Where like features are described, like reference numbers increased by 400 are used.

[0055] The transport device (500) of FIG. 5 includes a source of transport medium (504) and a source of replacement medium ( a fluid mixer fluidly connected to the fluid outlet (508); The device is shown equipped with a sir (502).

[0056] The delivery device (500) includes an elongated housing (510), which in this embodiment is tubing. The elongated housing (510) is fluidly coupled at a second end to the fluid mixer (502). and at a first end is fluidly connected to a source of replacement medium (506).

[0057] In the example shown in FIG. 5, the fluid mixer (502) includes a T-junction (540) for mixing the fluids. The T-junction (540) is connected to the outlet (508). To facilitate washing of the particles, a check valve (542) connectable to a washing fluid is included.

[0058] The chamber (514) of this embodiment also regulates the flow of particulates into the elongated housing (510). A first fluid control valve (536) for controlling the flow of the fluid is connected to the first fluid control valve (536) of the elongated housing (510). Thus, in this embodiment, the source of replacement medium (506) is The chamber is not directly connected to the elongated housing as in the first embodiment described above with reference to FIG. The connector (510) is directly connected to the connector (512).

[0059] In operation, a transport medium from a transport medium source (504) passes through the fluid mixer (502). and exits through the fluid outlet (508).

[0060] The fluid control valve (536) controls the flow of fluid from the chamber (514) into the elongated housing (510). The replacement medium source (506) may be opened to facilitate the flow of particulates and fluids. The displacement medium drawn from the elongated housing (510) moves into the elongated housing (510) and displaces the particulates. The fluid mixer (502) is pushed from the housing (510) of the fluid mixer (50 2) is used to transport the transfer medium containing the particulates and the replacement medium to the patient. and transports the particles through the fluid outlet (508).

[0061] The chamber (514) and the fluid control valve (536) are shown in FIG. (514) includes a cone-shaped portion (526) for pouring the particles, and a flow control valve (5 When the microparticles and carriers are disposed within the chamber (514), the microparticles and carriers are disposed within the chamber (514) when the microparticles and carriers are disposed within the chamber (514). The fluid is pumped through tubing (538) into the elongated housing (510). The fluid control valve (536) reduces or prevents the flow of particulates into the elongated housing (510). The tubing (538) may be closed to control the flow of the fluid through the chamber (514). It is fluidly connected to a control valve (536).

[0062] Referring to FIG. 7, the chamber (514) is separated from the remainder of the transport device (500). The chamber (514) is shown with a small amount of particulate or granules in it. 1. The fluid control valve (536) is disconnected for the purpose of filling the suction pipe with the carrier fluid, or both. The chamber (514) is separated from the fluid control valve (536). directional displacement, i.e., from the cone-shaped portion (526) to the fluid control valve (536) The fluid control valve (536) is disconnected by disconnecting the extending tubing (538). The chamber (514) connects the tubing (538) to the fluid control valve (536). It can be relinked by reinsertion.

[0063] A side view of the fluid mixer (502) is shown in Figure 8. The arrows shown in Figure 8 indicate the The direction of flow of the transport medium is shown from a medium source (not shown) to a fluid outlet (not shown). The fluid mixer (502) in this example is a T-junction and includes a conduit (522). and a dispenser (524) disposed within the conduit. In use, the particulate is dispensed From the dispenser (524) flows the transport medium which passes through the fluid mixer (502). The dispenser (524) directs the particles in the direction of the flow of the transport medium. 524) is substantially concentric with the conduit to direct the particles toward the center of the fluid flow. .

[0064] During use, changing the delivery device (500) will maintain the same behavior for both filling and fluid delivery. Optionally, the orientation of the transport device (500) may be adjusted to maintain momentum within the chamber (514). The device may be modified to facilitate removal of trapped gases such as air.

[0065] An example of a device in which the microparticles can be loaded is the transport device shown in FIG. A source (504), a source of displacement medium (506), or a chamber that supplies particulates to the device. Except (514).

[0066] Reference is now made to Fig. 9, which illustrates another example of a transport device according to the present disclosure. Many of the features are similar to those described above with reference to Figures 1 to 4 and may be omitted to avoid obscuring the description. Similar features are described with reference to FIG. Where applicable, similar reference numbers are used, but increased by 800.

[0067] The transport device (900) of FIG. 9 includes a source of transport medium (904) and a source of replacement medium (905). a fluid mixer fluidly connected to the fluid outlet (908); The transport device (900) is shown equipped with a tubing (902) in this embodiment. The elongated housing (910) includes a second end. a fluid mixer (902) at a first end and a source of displacement medium at a second end. (906) is fluidly connected to

[0068] In the example shown in FIG. 9, the fluid mixer (902) includes a T-junction. 04) and the displacement medium (906) enter the T-junction from two branches and then The fluid flows through the tubing, exits the T-junction, and into the fluid outlet (908). The T-junction of the mixer (902) is directly adjacent to the second T-junction. After passing through a second T-junction, the fluid (904) enters the fluid mixer (902). The T-junction of the main mixer (902) and the second T-junction must be directly adjacent to each other. However, they need not be, and could alternatively be separated by a length of tubing, for example.

[0069] In operation, the transport medium (904) passes through the fluid mixer (902) and exits the fluid outlet (904). 08). The displacement medium (906) moves into the elongated housing (910), and The particulates are forced from the elongated housing (910) into the fluid mixer (902). The transfer medium passing through the pump (902) delivers the transfer medium containing the particulates and the replacement medium to the patient. The particulates are conveyed through a fluid outlet (908) for transport.

[0070] In contrast to the embodiment described above with respect to FIG. 1, the chamber (914) in this embodiment is elongated. There is no fluid interposed between the housing (910) and the source of replacement medium (906). The chamber (914) accommodates a flow of the displacement medium from the source (906) to the liquid outlet (908). In this embodiment, the chamber (914) is located outside the fluid flow path. 2) to the second end of the elongated housing (910).

[0071] The exemplary transport device shown in FIG. 9 further includes a source of cleaning medium (950), which is (i) an elongated and (ii) a housing (910) connecting the transport medium (904) and the fluid outlet (908). The source of cleaning medium (950) is optional and may be replaced. A fluid control valve fluidly connecting the source of medium (906) and the source of transport medium (904). (952) is also optional.

[0072] To fill the elongated housing (910) with particulates from the chamber (914), A suction syringe (944) is used to apply a vacuum to the filler fluid outlet (946) to dispense the filler fluid containing the particulates. Filling fluid is drawn from the chamber (914) into the elongated housing (910). The nozzle (948) prevents or prevents particles from being drawn into the aspirating syringe (944) during filling. They are positioned to suppress or

[0073] Although not shown in FIG. 9, a device may be provided to direct the flow of fluid to a desired portion of the transport device. A fluid control valve may be included. For example, the delivery device may include a filter (948) and a fill fluid outlet (9 46) between the fill fluid outlet and the fill fluid outlet. Such a flow control valve may be provided to allow the replacement medium to flow to the fill fluid outlet. During delivery of particulates to the patient to reduce or prevent escape from the mouth (946). In another embodiment, the transport device may connect the fluid control valve to the source of transport medium (904 ) and the mixer (902). Such a flow control valve may be included between the Reduces inflow into the tubing connecting (902) and the source of transfer medium (904). or may be closed during loading of the elongated housing (910) with particulates to prevent .

[0074] An example of a device in which the microparticles can be loaded is the transport device shown in FIG. A source (904), a source of replacement medium (906), a chamber (91) for supplying the particles to the device. 4), excluding the aspirating syringe (944), or the source of cleaning medium (950).

[0075] In the above description, for purposes of explanation, numerous details are set forth in order to provide a thorough understanding of the embodiments. However, it will be apparent to one skilled in the art that these specific details are not required. Therefore, what has been described is merely illustrative of the application of the described embodiments and is not intended to be limiting of the scope of the invention. Many modifications and variations are possible in light of the above teaching.

[0076] The above description provides examples, and modifications and variations may be made to particular embodiments by those of ordinary skill in the art. It will be understood that the claims may be implemented as set forth herein. The present invention should not be limited by the specific examples described, but should be consistent with the specification as a whole. should be interpreted in a manner that

Claims

1. 1. A delivery device for intravenous delivery of microparticles to a patient, comprising: The delivery device includes (i) a first source of infusion medium, and (ii) a second source of infusion medium. a source of fluid communication with said transport device; a first fluid inlet fluidly connectable to a first source of infusion medium; fluid outlet, a fluid mixer fluidly connecting the first fluid inlet to the fluid outlet; a second fluid inlet fluidly connectable to a second source of the infusion medium; and a source of particulate fluidly connecting the second fluid inlet to the fluid mixer; a second source of infusion medium flows into the delivery device; A second infusion medium fluidly drives particulates from the particulate source to the fluid mixer. Move and, the fluid outlet dispenses the infusion medium containing the particulates to a patient. transport equipment.

2. the source of particulates includes an elongated housing that holds the particulates; The elongated housing is fluidly connected to the fluid mixer at one end and to a distal end 10. The transport device of claim 1, wherein the transport device is fluidly connectable to a second source of infusion medium at a first port.

3. The transport device is fluidly disposed between the elongated housing and the second fluid inlet. The transport device of claim 2 , further comprising a chamber defining a space for receiving the transport material.

4. The chamber is located within the chamber when the transport device is in a particulate loading orientation.

4. The transport device of claim 3, further comprising a conical portion for funneling particulate matter into said elongated housing. sending device.

5. The fluid mixer comprises: a conduit for a first infusion medium, the conduit fluidly connecting the first fluid inlet to the fluid outlet; the conduit connecting it; and A dispenser disposed in the conduit for dispensing the fluid passing through the fluid mixer. The dispenser is configured to add particles to the infusion medium in the direction of the infusion medium flow. Spencer, The transport device of any one of claims 1 to 4, comprising:

6. The conduit and the dispenser are concentric tubes, and the dispenser The transport device of claim 5 .

7. The fluid mixer is configured to move the first fluid in a substantially horizontal direction when the transport device is in a transport position.

7. The transport device of claim 1, configured to deliver an infusion medium of

8. The fluid mixer is configured to move the first fluid in a substantially vertical direction when the transport device is in a transport position.

7. The transport device of claim 1, configured to deliver an infusion medium of

9. a particulate trap fluidly positioned between the particulate source and the fluid mixer; The transport device according to any one of claims 1 to 8, comprising:

10. The particulate trap includes a tubing that connects the particulate source to the fluid mixer.

10. The transport device of claim 9, comprising approximately a 90 degree bend or U-turn in the loop.

11. The source of the first infusion medium is different from the source of the second infusion medium, and optionally According to any one of claims 1 to 10, the first injection medium and the second injection medium are the same. The transport device described.

12. the transport device defines a flow path for the particulate; The particulate flow path includes the particulate source, the fluid mixer, and the fluid outlet. A transport according to any one of claims 1 to 11, including the first and second fluidic connections and all fluid connections therebetween. Device.

13. 2. The method of claim 1, wherein the flow path diameter of the microparticle is at least three times the average diameter of the microparticle.

3. The transport device according to claim 2.

14. The cross section of the flow path of the particles is substantially uniform from the source of the particles to the fluid mixer.

14. The transport device of claim 12 or 13, wherein the

15. The particulates are loaded into the particulate source at a loading efficiency of about 80% to about 40%. A transport device according to any one of claims 1 to 14.

16. The microparticles have a specific gravity greater than that of the injection medium.

13. A transport device according to claim 1 .

17. 1. A method for delivering microparticles to a patient, the method comprising: A first injection medium is flowed into a first arm of a fluid mixer, and the first injection medium is flowed into a first arm of the fluid mixer. causing outflow from the second arm; and independently flowing the second infusion medium into a third arm of the fluid mixer; The second injection medium is used to inject the microparticles filled in the elongated housing into the first injection medium. and fluidly driving the microparticles, the first infusion medium, and the A mixture of the two injection media is produced, and The mixture exiting the second arm of the fluid mixer is administered intravenously to a patient. thing, A method comprising:

18. The flow rate of the first infusion medium is about 2 to about 80 times the flow rate of the second infusion medium. The method according to claim 17.

19. The flow rate of the first infusion medium is about 20 to about 40 times the flow rate of the second infusion medium.

20. The method of claim 17.

20. The total flow rate of the first infusion medium and the second infusion medium is equal to or greater than the local blood flow rate at the time of administration. The method according to any one of claims 17 to 19, wherein the method is substantially the same as

21. About 1 mg to about 200 mg of microparticles per total mL of infusion medium is administered intravenously to the patient. The method according to any one of claims 17 to 20, wherein the

22. 17-2, wherein the microparticles are administered at a rate of about 1 mg per second to about 200 mg per second.

2. The method according to any one of claims 1 to 11.

23. 1. A delivery device for intravenous delivery of microparticles to a patient, the delivery device comprising a transfer medium and and a displacement medium, said transport device being: a first fluid inlet fluidly connectable to the transport medium; fluid outlet, a fluid mixer fluidly connecting the first fluid inlet to the fluid outlet; a source of particulate fluidly connected to the fluid mixer; and a second fluid inlet fluidly connectable to the displacement medium; The second fluid inlet is connected to the fluid inlet and utilizes the displacement medium to displace the particulates into the fluid. a mixer and passing the particulates through the transport medium through the fluid outlet. , transport equipment.

24. 1. An apparatus for loading microparticles for intravenous delivery to a patient, said apparatus comprising: a displacing medium and a fluidly connectable device; a first fluid inlet fluidly connectable to the transport medium; fluid outlet, a fluid mixer fluidly connecting the first fluid inlet to the fluid outlet; a receptacle configured to hold a particulate and fluidly coupled to the fluid mixer; the receptacle connected to a receptacle that is fluidly connectable to the replacement medium and is fluidly connectable to the receptacle; a second fluid inlet fluidly connected to the fluid mixer by the receptacle; the second fluid inlet 13. An apparatus comprising:

25. The receptacle is fluidly connected at a first end to the second fluid inlet and 25. The apparatus of claim 24, fluidly connected to the fluid mixer at two ends.

26. 25. The method of claim 24, further comprising: a fill fluid inlet fluidly connected to the receptacle.

26. The apparatus described in 25.

27. The receptacle (a) fluidly connects the fill fluid inlet and the fluid mixer. or (b) fluidly connecting said fill fluid inlet and said fill fluid outlet.

7. The apparatus described in 6.

28. a filter fluidly disposed between the receptacle and the fill fluid outlet.

28. The apparatus of claim 27.

29. The fluid mixer according to any one of claims 24 to 28, wherein the fluid mixer is a T-junction. Device.

Images