CATHETER AND SYSTEM FOR INJECTION OF GAS-ENRICHED LIQUID DIRECTLY TO A PATIENT - Patent application

Abstract

The catheter includes a catheter body, a first lumen extending through the catheter body, one or more second lumens extending through the catheter body, and two or more capillaries extending from the catheter body and connected to the second lumen. The first lumen at least one of receiving a sample of blood from the patient's vascular system or measuring a parameter of the blood. The second lumen receives a gas-enriched liquid from a gas-enriched liquid source. The capillaries receive the gas-enriched liquid from the one or more second lumens and simultaneously distribute respective streams of the gas-enriched liquid directly into the vascular system such that the streams of gas-enriched liquid cross and mix with the blood in a region beyond the first lumen beyond the end of the catheter body.

Description

[Technical field]

[0001] [Priority claim] This application claims priority under 35 U.S.C. § 119(e) to U.S. Provisional Patent Application No. 63 / 151,422, filed February 19, 2021, the entire contents of which are incorporated herein by reference.

[0002] The present disclosure relates to catheters and systems for infusing gas-enriched liquids into a patient. [Background technology]

[0003] Gas-enriched liquids are desirable for a wide range of applications. However, at ambient pressure, many gases, such as oxygen or nitrogen, have relatively low solubility in liquids, such as water, producing relatively low concentrations of dissolved gas in the liquid. One method of obtaining increased gas concentration levels without significantly increasing the volume of the liquid involves injecting and mixing a gas-enriched liquid, such as a gas-supersaturated liquid, into the liquid of interest. Liquids can be gas-enriched at high pressures.

[0004] Conventional methods for delivering oxygenated blood or oxygen-enriched liquids to tissues and bodily fluids involve the use of extracorporeal circuits for blood oxygenation, which require drawing blood from a patient, circulating the blood through an artificial lung to increase the blood oxygen concentration, and then delivering the blood back to the patient. Summary of the Invention

[0005] In an embodiment, the catheter is configured to be inserted into a patient's vascular system. The catheter includes an elongated catheter body, a first lumen extending through the catheter body, one or more second lumens extending through the catheter body, and two or more capillaries extending from the catheter body and coupled to the one or more second lumens. The first lumen may be configured to be in fluid communication with the patient's vascular system when the catheter is inserted into the patient's vascular system, and the first lumen may be configured to perform at least one of receiving a sample of the patient's blood from the patient's vascular system or measuring a parameter of the patient's blood. The one or more second lumens may be configured to receive a gas-enriched liquid from a gas-enriched liquid source. Each of the two or more capillaries is in fluid communication with the one or more second lumens and is configured to be in fluid communication with the patient's vascular system when the catheter is inserted into the patient's vascular system. Each of the two or more capillaries can be configured to receive gas-enriched liquid from the one or more second lumens and can be configured to simultaneously distribute a respective stream of gas-enriched liquid directly into the patient's vascular system.

[0006] The catheter body may be configured to position the two or more capillaries at one or more predetermined angles relative to each other such that the flow of the gas-enriched liquid crosses and mixes with the patient's blood in a region beyond the end of the catheter body beyond the first lumen. The first lumen may be recessed relative to the output end of each of the two or more capillaries. The first lumen may be recessed longitudinally or axially in the catheter body relative to the output end of each of the two or more capillaries. The capillaries may also be referred to as capillary tubes, or simply as tubes. The first lumen may extend with one or more second lumens. The first lumen may be fluidly separated from one or more second lumens within the body of the catheter.

[0007] Implementations of this aspect may include one or more of the following features.

[0008] In some implementations, the gas-enriched liquid may be a supersaturated oxygen-enriched liquid.

[0009] In some implementations, the first lumen can be configured to receive a guidewire to position the catheter relative to a patient's vasculature.

[0010] In some implementations, the catheter can further include a pressure sensor disposed in the first lumen. The pressure sensor can be configured to obtain one or more pressure measurements.

[0011] In some implementations, the parameter of the patient's blood may be at least one of a partial pressure of oxygen in the patient's blood, a SO2 of the patient's blood, a pressure of the patient's blood, a flow rate of the patient's blood, or a temperature of the patient's blood.

[0012] In some implementations, the first lumen can range in diameter from 0.020 inches (about 0.5 mm) to 0.045 inches (about 1.1 mm).

[0013] In some implementations, the catheter can include a third lumen extending through the catheter body. The third lumen can be configured to be in fluid communication with the patient's vascular system when the catheter is inserted into the patient's vascular system. The third lumen can be configured to at least one of receive an additional sample of the patient's blood from the patient's vascular system and measure an additional parameter of the patient's blood.

[0014] In some implementations, the catheter body can be configured to position two or more capillaries such that the flow of gas-enriched liquid intersects a longitudinal axis extending through the center of the catheter.

[0015] The catheter body may be configured to dispose two or more capillaries, which may be configured for intersecting flow of gas-enriched liquid.

[0016] In some implementations, the catheter body can be configured to arrange two or more capillaries so that the flow of gas-enriched liquid does not intersect with a longitudinal axis extending through the center of the catheter.

[0017] In some implementations, the catheter may further include one or more shields or guards disposed across the distal opening of the first lumen and configured to reduce nucleation along one or more surfaces of the catheter.

[0018] In some implementations, at least one of the predetermined angles may be in the range of 10 to 80 degrees.

[0019] In some implementations, the diameter of at least one of the two or more capillaries and the diameter of at least another one of the two or more capillaries may be equal.

[0020] In some implementations, the diameter of at least one of the two or more capillaries can be different from the diameter of at least another one of the two or more capillaries.

[0021] In some implementations, at least one of the two or more capillaries can have an inner diameter in the range of 40 microns to 100 microns.

[0022] In some implementations, at least one of the two or more capillaries can have an outer diameter in the range of 140 microns to 400 microns.

[0023] In some implementations, two or more capillaries may comprise one or more elongated tubes extending from the catheter body.

[0024] In some implementations, the distance between (i) the intersection point of the gas-enriched liquid flow and (ii) the end tip of the catheter or the output opening of the first lumen can be greater than or equal to the diameter of the end tip of the catheter.

[0025] In some implementations, the distance between (i) the output ends of the two or more capillaries and (ii) the end tip of the catheter or the output opening of the first lumen can be greater than or equal to the diameter of the end tip of the catheter.

[0026] In some implementations, at least one capillary may include fiducial markings.

[0027] In some implementations, the gas-enriched liquid streams can cross and mix with the patient's blood without the formation of gas bubbles.

[0028] In some implementations, the flow of gas-enriched liquid can cross and mix with the patient's blood over the end of the catheter body and in areas beyond the first lumen to reduce bubble nucleation along one or more surfaces of the catheter or capillary.

[0029] In some implementations, the catheter may further include one or more sensors that may be configured to be in fluid communication with the patient's vascular system when the catheter is inserted into the patient's vascular system.

[0030] In some implementations, at least one of the one or more sensors can be a partial pressure of oxygen (pO2) sensor.

[0031] In some implementations, the catheter can further comprise a self-centering device configured to center the catheter body within the patient's vasculature.

[0032] In some implementations, the self-centering device can include one or more mesh structures that surround the catheter body.

[0033] In another aspect, a system can include a catheter as described herein and a fluid dispensing device in fluid communication with the one or more second lumens. The fluid dispensing device can include one or more pumps configured to supply gas-enriched liquid to the one or more second lumens.

[0034] Implementations of this aspect may include one or more of the following features.

[0035] In some implementations, the system can include one or more connectors configured to couple the one or more second lumens to one or more respective dispense ports of the fluid dispensing device.

[0036] In some implementations, at least one of the one or more connectors can be a high pressure luer fitting.

[0037] In some implementations, the gas-enriched liquid may include one or more of oxygen, ozone, an inert gas, nitrogen, nitrous oxide, carbon dioxide, or air.

[0038] In some implementations, the gas-enriched liquid may have a dissolved oxygen (O2) concentration in the range of 0.2 and 3 ml O2 / ml solvent.

[0039] In some implementations, the gas-enriched liquid may contain a dissolved oxygen (O2) concentration of 0.1-6 ml O2 / ml liquid (STP), or 0.2-3 ml O2 / ml liquid (STP).

[0040] In another aspect, a system includes a catheter as described herein and a blood sampling device in fluid communication with the first lumen. The blood sampling device can be configured to draw a sample of the patient's blood from the patient's vascular system into the first lumen.

[0041] Implementations of this aspect may include one or more of the following features.

[0042] In some implementations, two or more capillaries may be coated with a hydrophilic coating.

[0043] In another aspect, a catheter is configured to be inserted into a patient's vascular system. The catheter comprises an elongated, coiled catheter body, a first lumen extending therethrough, the first lumen configured to receive a gas-enriched liquid, and a plurality of openings disposed along the length of the catheter body. The plurality of openings are in fluid communication with the first lumen. The openings are configured to dispense the gas-enriched liquid directly into the patient's vascular system.

[0044] Implementations of this aspect may include one or more of the following features.

[0045] In some implementations, the gas-enriched liquid may be a supersaturated oxygen-enriched liquid.

[0046] In some implementations, the catheter can include one or more periodically repeating curves.

[0047] In some implementations, the length of each of the periodically repeating turns can be variable.

[0048] In some implementations, the catheter body can have an inner diameter ranging from 0.020 inches (about 0.5 mm) to 0.045 inches (about 1.1 mm).

[0049] In some implementations, the catheter body can have an outer diameter in the range of 4F to 12F (about 1.33 mm to about 4 mm).

[0050] In some implementations, the catheter can be constructed at least in part from a shape memory material.

[0051] In some implementations, one or more surfaces of the catheter may be composed of at least one of polycarbonate, glass, ceramic, stainless steel, polyetheretherketone (PEEK), or polyimide.

[0052] In some implementations, the catheter body can extend along an axial direction, and at least a portion of the openings can face in one or more radial directions perpendicular to the axial direction.

[0053] In some implementations, each of the apertures can be located at a different respective radial position about the catheter body.

[0054] In some implementations, the catheter body can extend along an axial direction, and each of the openings can face in one or more radial directions perpendicular to the axial direction.

[0055] In some implementations, each of the apertures can have a diameter in the range of 40 microns to 100 microns.

[0056] In some implementations, each of the openings can have a circular shape.

[0057] In some implementations, the catheter body can extend along a helical path.

[0058] In some implementations, the catheter body can extend along a helical path having a variable diameter.

[0059] In some implementations, adjacent openings can be offset from one another along the catheter body by a distance ranging from 1 cm to 5 cm.

[0060] In some implementations, the catheter body can be configured to receive a guide rod.

[0061] In some implementations, the catheter body can be configured such that at least a portion of the catheter body is curvature-reduced when the guide rod is inserted into the catheter body.

[0062] In some implementations, the catheter may further include one or more elongated tubes extending from the catheter body. The one or more elongated tubes may include one or more second lumens in fluid communication with the opening. The one or more elongated tubes may be configured to receive the gas-enriched liquid from the opening and dispense the gas-enriched liquid directly into the patient's vascular system.

[0063] In some implementations, at least one of the one or more elongate tubes may branch into one or more respective portions, each defining a respective third lumen in fluid communication with the first lumen.

[0064] In some implementations, the gas-enriched liquid may include one or more of oxygen, ozone, an inert gas, nitrogen, nitrous oxide, carbon dioxide, or air.

[0065] In some implementations, the gas-enriched liquid may have a dissolved oxygen (O2) concentration ranging from 0.2 to 3 ml O2 / ml solvent.

[0066] In some implementations, the gas-enriched liquid may contain a dissolved oxygen (O2) concentration of 0.1-6 ml O2 / ml liquid (STP), or 0.2-3 ml O2 / ml liquid (STP).

[0067] In another aspect, a system includes a catheter as described herein and a fluid dispensing device in fluid communication with the first lumen, the fluid dispensing device including one or more pumps configured to supply a gas-enriched liquid to the first lumen.

[0068] Implementations of this aspect may include one or more of the following features.

[0069] In some implementations, the catheter can include a connector configured to couple the first lumen to a dispensing port of a fluid dispensing device.

[0070] In some implementations, the connector may be a luer fitting.

[0071] In another aspect, a catheter is configured to be inserted into a patient's vascular system. The catheter comprises an elongated catheter body, a first lumen extending through the catheter body, where the first lumen is configured to receive a gas-enriched liquid, and a plurality of elongated tubes extending along the catheter body. Adjacent elongated tubes may be offset from one another along the catheter body. Each of the elongated tubes includes a respective second lumen in fluid communication with the first lumen. The elongated tubes are configured to receive the gas-enriched liquid from the first lumen and dispense the gas-enriched liquid directly into the patient's vascular system.

[0072] Implementations of this aspect may include one or more of the following features.

[0073] In some implementations, the gas-enriched liquid may be a supersaturated oxygen-enriched liquid.

[0074] In some implementations, at least one of the elongate tubes may branch into one or more respective portions.

[0075] In some implementations, each of the portions can be in fluid communication with the first lumen.

[0076] In some implementations, each of the sections can include a respective output end, and each of the output ends can be located at a different respective radial position about the catheter body.

[0077] In some implementations, the catheter body can have an inner diameter ranging from 0.020 inches (about 0.5 mm) to 0.045 inches (about 1.1 mm).

[0078] In some implementations, the catheter body can have an outer diameter in the range of 4F to 12F (about 1.33 mm to about 4 mm).

[0079] In some implementations, at least one of the elongate tubes can have an inner diameter in the range of 40 microns to 100 microns.

[0080] In some implementations, at least one of the elongate tubes can have an outer diameter in the range of 140 microns to 400 microns.

[0081] In some implementations, at least one of the elongate tubes can include a circular cross-section.

[0082] In some implementations, adjacent elongate tubes can vary in length from one another, ranging from 1 cm to 5 cm in length.

[0083] In some implementations, adjacent elongate tubes can be offset from one another along the catheter body by a distance ranging from 1 cm to 5 cm.

[0084] In some implementations, the gas-enriched liquid may include one or more of oxygen, ozone, an inert gas, nitrogen, nitrous oxide, carbon dioxide, or air.

[0085] In some implementations, the gas-enriched liquid may have a dissolved oxygen (O2) concentration ranging from 0.2 to 3 ml O2 / ml solvent.

[0086] In some implementations, the gas-enriched liquid may contain a dissolved oxygen (O2) concentration of 0.1-6 ml O2 / ml liquid (STP), or 0.2-3 ml O2 / ml liquid (STP).

[0087] In some implementations, at least one capillary may include a fiducial marking.

[0088] In some implementations, the catheter can be flexible enough to be guided through a catheter delivery system.

[0089] In another aspect, a system includes the catheter described above and a fluid dispensing device in fluid communication with the first lumen. The fluid dispensing device can include one or more pumps configured to supply a gas-enriched liquid to the first lumen.

[0090] In some implementations, the catheter can include a connector configured to couple the first lumen to a dispensing port of a fluid dispensing device.

[0091] In some implementations, the connector may be a luer fitting.

[0092] In general, implementations described with respect to one aspect can be provided in combination with other aspects. The details of one or more embodiments are set forth in the accompanying drawings and description. Other features and advantages will be apparent from the description and drawings, and from the claims. [Brief description of the drawings]

[0093] [Figure 1A] 1 is a diagram of an exemplary system for enriching bodily fluids with a gas-enriched liquid inside an enclosed region of the body. [Figure 1B] 1 is a diagram of an exemplary system for enriching bodily fluids with a gas-enriched liquid inside an enclosed region of the body.

[0094] [Figure 2A] FIG. 1 is a diagram of an exemplary catheter. [Figure 2B] FIG. 1 is a diagram of an exemplary catheter.

[0095] [Figure 3A] FIG. 1 is a diagram of another exemplary catheter. [Figure 3B] FIG. 1 is a diagram of another exemplary catheter.

[0096] [Figure 4A] FIG. 1 is a diagram of another exemplary catheter. [Figure 4B] FIG. 1 is a diagram of another exemplary catheter.

[0097] [Figure 5A] FIG. 1 illustrates an exemplary catheter including an inflated balloon structure.

[0098] [Figure 5B] 1A-1C are diagrams of an exemplary catheter including an expandable mesh structure.

[0099] [Figure 6A] FIG. 1 illustrates an exemplary configuration of a capillary tube of a catheter. [Figure 6B] FIG. 1 illustrates an exemplary configuration of a capillary tube of a catheter. [Figure 6C] FIG. 1 illustrates an exemplary configuration of a capillary tube of a catheter.

[0100] [Figure 7A] FIG. 2 is a diagram of another exemplary system for enriching bodily fluids with a gas-enriched liquid inside an enclosed region of the body. [Figure 7B] FIG. 2 is a diagram of another exemplary system for enriching bodily fluids with a gas-enriched liquid inside an enclosed region of the body. [Figure 7C] FIG. 2 is a diagram of another exemplary system for enriching bodily fluids with a gas-enriched liquid inside an enclosed region of the body.

[0101] [Figure 8A] 1A-1C illustrate the insertion of a guide rod into an exemplary catheter. [Figure 8B] 1A-1C illustrate the insertion of a guide rod into an exemplary catheter.

[0102] [Figure 9A] FIG. 1 illustrates an exemplary catheter having a tubular branching structure.

[0103] [Figure 9B] FIG. 1 is a diagram of an exemplary catheter having a tubular structure. DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENTS

[0104] 1A illustrates an exemplary system 100 for enriching bodily fluids with dissolved gas or gas-enriched liquid inside an enclosed region of the body. By way of example, the system 100 can be used to enrich a patient's blood with supersaturated oxygen-enriched liquid or supersaturated liquid within the patient's vasculature, thereby delivering supersaturated oxygen (SSO2) therapy to the patient and increasing oxygen in the blood and diffusion of oxygen to the tissues. In certain implementations, the oxygen-enriched liquid or solution, e.g., the supersaturated oxygen-enriched liquid or solution, can include liquids with a dissolved O2 concentration of 0.1 ml O2 / ml liquid (STP) or greater, or 0.1-6 ml O2 / ml liquid (STP), or 0.2-3 ml O2 / ml liquid (STP) (e.g., without clinically significant gas embolism).

[0105] 1A, the system 100 includes a catheter 102, a gas-enriched liquid source 150, a pump 152, a sensor 154, and a sample extraction device 156. The catheter 102 is configured for insertion into a patient's vascular system to facilitate delivery of gas-enriched liquid (e.g., from the gas-enriched liquid source 150) to the patient's vascular system via the pump 152. Additionally, the catheter 102 is configured to facilitate measurement of one or more characteristics of the patient's blood within the patient's vascular system (e.g., by providing access to the patient's vascular system for the sensor 154) and / or to facilitate collection of a blood sample from the patient's vascular system (e.g., by providing access to the patient's vascular system for the sample extraction device 156). For example, the sensor 154 may be disposed at a distal (or first) end 108a of the catheter 102 or in a communicating lumen of the catheter 102. The sensor 154 may detect various blood parameters (e.g., the partial pressure of oxygen (pO2) of the patient's blood, the oxygen saturation (SO2) of the patient's blood, the flow rate of the patient's blood, the temperature of the patient's blood) during treatment or after treatment has stopped or been completed.

[0106] The catheter 102 includes an elongated catheter body 104 (e.g., extending through the center of the catheter body 104 along a longitudinal axis 106) having a distal end 108a and an opposing proximal (or second) end 108b. In some implementations, the catheter may have a circular, elliptical, or oval cross-section along part or all of its length. In some implementations, the catheter body 104 may be flexible (e.g., may be bent or curved at one or more locations along its length). In some implementations, at least a portion of the catheter 102 and / or catheter body 104 may be constructed from polycarbonate, glass, ceramic, stainless steel, polyetheretherketone (PEEK), polyetherblockamide (PEBA) (e.g., PEBAX from Akrema SA of Colombes, France), acrylonitrile butadiene styrene (ABS), polyimide, and / or other suitable materials. In some implementations, the catheter body 104 can have an outer diameter ranging from 4F to 12F, or such as from 4F to 6F (according to the French scale - approximately 1.33 mm to 4 mm, or approximately 1.33 mm to 2 mm).

[0107] Additionally, the catheter 102 includes multiple lumens extending through the catheter body 104. In this example, the catheter 102 includes one or more communicating lumens 110a extending through the center of the catheter body 104 (e.g., along the longitudinal axis 106). At least two additional lumens 110b and 110c can extend through opposing sides of the catheter body 104 (e.g., parallel to the communicating lumen 110a). Each of the lumens 110a-110c can have a circular, elliptical, or oval cross-section along a portion or the entirety of its length. In some implementations, the communicating lumen 110a can have an inner diameter in the range of 0.020 inches to 0.045 inches (about 0.5 mm to about 1.1 mm).

[0108] Each of the lumens 110a-110c includes a respective input opening and a respective output opening. For example, the communicating lumen 110a includes an input opening 112a at the first (or distal) end 108a of the catheter body 104 and an output opening 112b at the second (or proximal) end 108b of the catheter body 104. As another example, the lumen 110b includes an input opening 114a at the first end 108a of the catheter body 104 and an output opening 114b at the second end 108b of the catheter body 104. As another example, the lumen 110c includes an input opening 116a at the first end 108a of the catheter body 104 and an output opening 116b at the second end 108b of the catheter body 104.

[0109] Additionally, the catheter 102 includes a capillary 118a extending from and in fluid communication with the output opening 114b of the lumen 110b (e.g., so that fluid can flow from the lumen 110b to the capillary 118a). The capillary 118a terminates at an output opening 120a. In some implementations, the capillary 118a can have an inner diameter between 40 microns and 100 microns. In some implementations, the capillary 118a can have an outer diameter between 140 microns and 160 microns. In some implementations, the capillary 118a can have a length in the range of 5 cm to 10 cm, or a length "l" that is substantially equal to the diameter of the catheter tip or distal end.

[0110] Additionally, the catheter 102 also includes a capillary tube 118b that extends from and is in fluid communication with the output opening 116b of the lumen 110c (e.g., so that fluid can flow from the lumen 110c to the capillary tube 118b). The capillary tube 118b terminates at an output opening 120b. In some implementations, the capillary tube 118b can have an inner diameter of 40 microns to 100 microns. In some implementations, the capillary tube 118b can have an outer diameter of 140 microns to 400 microns. In some implementations, the capillary tube 118b can have a length in the range of 5 cm to 10 cm, or a length "l" that is substantially equal to the diameter of the catheter tip or distal end.

[0111] In some implementations, the capillaries 118a and 118b can have the same or different inner and / or outer diameters. In some implementations, the capillaries 118a and 118b can have the same or different lengths.

[0112] During an exemplary use of the system 100, the gas-enriched liquid source 150 and the pump 152 are coupled by the catheter 102 such that the gas-enriched liquid source 150 and the pump 152 are in fluid communication with the input openings 114a and 116a of the lumens 110b and 110c, respectively. By way of example, one or more fluid-tight tubes may be used to transport the gas-enriched liquid from the gas-enriched liquid source 150 to the pump 152 and from the pump 152 to the input openings 114a and 116b. In some implementations, one or more fluid-tight tubes may be used to transport the gas-enriched liquid from the gas-enriched liquid source 150 to the input openings 114a and 116b, with at least a portion of the one or more fluid-tight tubes being coupled to or forming a portion of a peristaltic pump to urge the fluid from the gas-enriched liquid source to the input openings 114a and 116b. In some implementations, the tubing may be secured to the input openings 114a and 116b using fittings or connectors, such as high pressure Luer fittings.

[0113] In some implementations, the gas-enriched liquid source 150 may include one or more storage tanks for storing the gas-enriched liquid. In some implementations, the gas-enriched liquid may be a supersaturated oxygen-enriched liquid or a supersaturated liquid, such as a liquid having a dissolved oxygen (O2) concentration between 0.2 and 3 ml O2 / ml solvent (a concentration corresponding to 100 psi to 1500 psi). In some implementations, the gas-enriched liquid may include a liquid enriched with oxygen, ozone, inert gas, nitrogen, nitrous oxide, carbon dioxide, and / or air. In some implementations, the gas-enriched liquid source 150 may include an oxygenation device, which is operated by a console or hardware components that control the operation of the oxygenation device, as described in U.S. Pat. No. 9,919,276, the entire disclosure of which is expressly incorporated herein by reference in its entirety. The console or hardware components may include a controller, a processor, a memory, and associated circuitry. The oxygenation device may include a fluid supply chamber for receiving a physiological liquid, such as saline, from an IV bag, and an nebulization chamber for receiving a suitable gas, such as oxygen, from an oxygen tank. The saline is pumped into the oxygen pressurized nebulization chamber and nebulized to produce a gas-enriched or supersaturated liquid, such as supersaturated oxygen-enriched saline or supersaturated saline. In certain implementations, the gas-enriched liquid may be an oxygen-enriched liquid or solution, such as a supersaturated oxygen-enriched liquid or solution, and may include liquids with a dissolved O2 concentration of 0.1 ml O2 / ml liquid (STP) or greater, or 0.1-6 ml O2 / ml liquid (STP), or 0.2-3 ml O2 / ml liquid (STP) (e.g., without clinically significant gas embolism). In some implementations, the gas-enriched liquid can be a supersaturated oxygen-enriched liquid or solution (e.g., saline with a dissolved O2 concentration of 0.1 ml O2 / ml saline (STP) or greater, or 0.1-6 ml O2 / ml saline (STP) or 0.2-3 ml O2 / ml saline (STP)) (e.g., without clinically significant gas embolism).

[0114] Further, a portion of the catheter 102 is inserted into the patient, e.g., the second end 108b of the catheter body 104 is disposed within the patient's vascular system (e.g., a blood vessel 160, e.g., a blood vessel or an artery). After the catheter 102 is inserted into the patient, the pump 152 is actuated such that it draws gas-enriched liquid from the gas-enriched liquid source 150 and pumps the gas-enriched liquid, e.g., supersaturated liquid, into each of the lumens 110b and 110c. The gas-enriched liquid flows through the lumens 110b and 110c into the capillaries 118a and 118b and is discharged from the output openings 120a and 120b as two respective streams 122a and 122b.

[0115] In some implementations, the system 100 can be configured to output flows according to different flow rates and / or pressures. For example, the system 100 can be configured to output flows of 1 mL / min (e.g., at a pressure of 100 psi, about 690 kPa) to 3 mL / min (e.g., at a pressure of 300 psi, about 2 MPa).

[0116] The capillaries 118a and 118b are configured such that the flows 122a and 122b intersect with each other and mix at a mixing region 124 within the patient's vasculature. For example, the capillaries 118a and 118b may define respective paths that are angled with respect to the longitudinal axis 106, such that the flows 122a and 122b exit the output openings 120a and 120b at respective angles with respect to the longitudinal axis 106. In some implementations, the capillaries 120a and 120b may be configured such that the flows 122a and 122b intersect at a point 126 beyond the tip of the catheter 102 (e.g., the point 126 is on or around the longitudinal axis 106). For example, the flows 122a and 122b may mix without or without significant bubble formation in the mixing region 124, which is a distance downstream from the output openings of the capillaries 118a and 118b.

[0117] Additionally, the communication lumen 110a provides access to the patient's vascular system. For example, in some implementations, the sensor 154 may be at least partially inserted into the communication lumen 110a so as to be in fluid communication with the patient's blood. In other implementations, the sensor may be located outside the communication lumen or on the catheter wall. The sensor 154 may obtain one or more sensor measurements on the blood and provide feedback related to the measured parameters affected by the SSO2 therapy to optimize the SSO2 therapy. For example, the sensor 154 may measure the oxygen partial pressure of the patient's blood, the oxygen concentration or SO2 of the patient's blood, the pressure of the patient's blood, e.g., arterial blood pressure, the flow rate of the patient's blood, and / or the temperature of the patient's blood.

[0118] Examples of such sensors include:

[0119] One example of a sensor for measuring the partial pressure of oxygen (pO2) or oxygen saturation SO2 of a patient's blood is a pulse oximeter. A pulse oximeter can be used to measure arterial pO2 or SO2. A pulse oximeter estimates the percentage of oxygen bound to hemoglobin in the blood. A pulse oximeter uses a light-emitting diode and a light-sensitive sensor to measure the absorption of red and infrared light. In another example, to measure the partial pressure of oxygen, the sensor includes an electrode, such as a Clark electrode for measuring pO2. A Clark electrode is an electrode that measures the ambient oxygen concentration of a liquid using a catalytic platinum surface according to the net reaction O2 + 4e- + 4H+ → 2H2O. The various sensors can be connected to the system's controller via a cable or other hardwired or wireless connection.

[0120] A processor may receive signals from these sensors, which correspond to a measured value of pO2. The processor compares the measured pO2 to a target range of blood pO2, for example, 760 to 1500 mmHg (approximately 100 kPa to 200 kPa). The target range may be calculated based on a blood flow rate of 50 to 150 ml / min, a saline flow rate of 2 to 5 ml / min, and a dissolved O2 concentration in the saline of 0.2-3 ml O2 / ml saline (STP). A controller may adjust the saline flow rate and / or the dissolved O2 concentration in the saline based on the measured pO2 in the blood to achieve an arterial blood pO2 in the target range. The processor may issue an alert, for example, via a user interface, an audible alarm, and / or a visual alarm indicating the concentration of pO2. The measured pO2 indicates the effectiveness of supersaturated oxygen therapy and informs a caregiver whether the pO2 in the blood is in a target range for optimizing the delivery of oxygen to the patient's ischemic tissues. In certain implementations, the processor may control the delivery of supersaturated oxygen therapy by modifying one or more of the above reference saline or oxygen parameters based on the signal received from the sensor.

[0121] Another example of a sensor is an O2 fluorescent probe. The fluorescent probe may be connected to the system's controller via a cable or other wired or wireless connection. A light source of the O2 fluorescent probe is illuminated. A fiber optic cable may be used to provide light to the light source, in certain implementations, with the fiber optic cable connected to the system's controller. Fluorescence of a sensor molecule of the O2 fluorescent probe is measured. The sensor molecule may include a fluorescent molecule. A signal is received by the processor from the O2 fluorescent probe based on the fluorescence measurement. The fluorescence is measured by measuring the lifetime or decay of a fluorescence intensity signal from an illuminated sensor molecule (such as a fluorescent molecule) on the fluorescent probe. This signal decay is caused by the quenching effect of oxygen molecules in the blood or tissue on the fluorescence intensity signal of the sensor molecule. The processor can determine the oxygen concentration SO2 or pO2 in the blood or tissue based on the quenching effect of oxygen on the fluorescence intensity signal of the fluorescent probe. The change in time required for the signal to decay due to oxygen quenching is indicative of the local oxygen concentration SO2 or pO2 in the blood or tissue. The processor issues an alert, for example, via a user interface, an audible alarm, and / or a visual alarm, based on the determined blood or tissue oxygen concentration, SO2 or pO2. The alert may indicate the effectiveness of the supersaturated oxygen therapy. The determined oxygen concentration SO2 or pO2 indicates the effectiveness of the supersaturated oxygen therapy and informs a caregiver whether the blood oxygen concentration SO2 or pO2 is within a predefined target range (e.g., an expected range for a healthy individual) to optimize the delivery of oxygen to the patient. In certain implementations, the processor can control the delivery of the supersaturated oxygen therapy by modifying one or more of the saline or oxygen parameters, for example, the saline flow rate or the dissolved O2 concentration in the saline, based on the determined oxygen concentration SO2 or pO2 value.

[0122] Another example of a sensor is a temperature sensor located on the catheter. For example, a thermistor can be utilized to measure the temperature of the patient's blood. The processor can receive a signal from the thermistor, which corresponds to a measurement of the blood temperature. The processor can issue an alert, for example, via a user interface, an audible alarm, and / or a visual alarm indicating the temperature of the blood, which can alert a caregiver to hypothermia or hyperthermia, e.g., a fever condition, in the patient.

[0123] An exemplary sensor for measuring the arterial pressure of the patient's blood is a pressure sensor disposed or coupled to the communication lumen. The communication lumen may be used for direct measurement of arterial pressure. The communication lumen may be connected to a fluid filling system, which is connected to an electronic pressure transducer. A change in the detected blood pressure may indicate improved perfusion and / or restoration of flow in the ischemic tissue as a result of the SSO2 therapy. The therapy may result in improved cardiac function. In certain implementations, the processor may control the delivery of supersaturated oxygen therapy based on feedback of the arterial pressure.

[0124] Exemplary sensors used to determine blood flow rate include temperature sensors such as thermistors, thermocouples, or thermoanemometers. The temperature sensor may be located at the catheter tip, the capillary tip, or the communicating lumen. The temperature sensor may be heated to raise the temperature of the sensor. As blood flows past the temperature sensor, the temperature the temperature sensor cools to indicates the flow rate past the temperature sensor. The determined blood flow rate may be fed back to the system to indicate the effectiveness of SSO2 therapy in improving perfusion and / or restoring blood flow in the ischemic tissue. In certain implementations, the processor may control the delivery of supersaturated oxygen therapy based on the blood flow rate feedback.

[0125] If the sensor is a pressure sensor, the sensor may detect the pressure difference between the ambient pressure and the arterial pressure or the absolute value of the arterial pressure. The pressure sensor may be located anywhere in the communication lumen, but does not necessarily have to be located in the communication lumen, and may be located outside the lumen. One example of a pressure sensor is a strain gauge. In a catheter with multiple communication lumens, the pressure sensor may be located in a first communication lumen that provides an uninterrupted pressure signal, while blood sampling may be performed simultaneously through a second communication lumen. In another example, two pressure sensors may be used, one located in the first communication lumen and one located in the second communication lumen, providing redundancy of pressure readings.

[0126] As another example, in some implementations, the sample extraction device 156 may be used to obtain a sample of the patient's blood through the communicating lumen 110a. For example, the sample extraction device 156 may include one or more pumps or syringes to draw a sample of the patient's blood through the lumen 110a and out of the patient's body. The syringe may be coupled to the proximal end of the catheter for sampling. A valve or stopcock may be included at the proximal end of another lumen of the catheter to control sampling.

[0127] In some implementations, the communicating lumen 110a can also be used to guide the catheter 102 within the patient's body. For example, a guidewire can be inserted into the communicating lumen 110a and manipulated to control the shape and / or placement of the catheter 102 within the patient's body.

[0128] Additionally, catheter 102 may be configured to eliminate or otherwise reduce the formation of air bubbles within the patient's vasculature. For example, flows 122a and 122b may mix in a mixing region 124 away from any surfaces of catheter 102 or the capillaries to reduce, hinder, or reduce the likelihood of air bubble formation due to nucleation on the surfaces of catheter 102 or the capillaries.

[0129] 1B, the output opening 112b of the communication lumen 110a is recessed (e.g., a distance d along the longitudinal axis 106) from the output openings 120a and 120b of the capillaries 118a and 118b. Accordingly, the flows 122a and 122b are less likely to impinge on the surface of the lumen 110a, thereby further impeding or reducing the likelihood of bubble formation via nucleation. Furthermore, the flows 122a and 122b are less likely to interfere with the acquisition of sensor measurements by the sensor 154. In some implementations, the distance d can be selected based on the size of the tip of the catheter 102. For example, the distance d can be at least as long as the diameter of the tip or distal end of the catheter 102. In some implementations, the distance d can be 0.060 inches (about 1.5 mm) to 0.100 inches (about 2.5 mm). As shown in FIGS. 1A and 1B, in some implementations, the catheter 102 may also include one or more shields or guards 128 (e.g., protrusions, walls, bumps, etc.) positioned over the output opening 112b to reduce nucleation along one or more surfaces of the catheter.

[0130] In certain examples, d is measured relative to the diameter of the catheter. The diameter of the catheter tip or distal end varies depending on factors such as the size of the artery, the blood flow rate, and blood backflow. The mixing region where the flows intersect may generate a mixing zone that is away from the catheter distal end. Since the diameter of the catheter tip affects the blood flow and turbulence in the mixing zone, it is important to ensure that the mixing zone is at least a distance d away from the catheter tip and the output opening of the communicating lumen. In certain examples, a distance d substantially equal to the diameter of the catheter tip is the minimum distance from the catheter tip where the mixing zone should be located. This helps to avoid the diameter of the catheter tip affecting the mixing. The recessed output opening of the communicating lumen also helps to ensure the reliability of the blood sample removed through the communicating lumen. It is desirable for the mixing zone to be at least a distance d away from the output opening of the communicating lumen to avoid sampling unmixed SSO2 solution. Also, during pressure detection, the sufficiently recessed output opening of the communicating lumen results in reduced noise during pressure measurement. In some implementations, the distance d can be from 0.060 inches (about 1.5 mm) to 0.100 inches (about 2.5 mm).

[0131] Additionally, each of the surfaces of the catheter 102 (e.g., the inner surfaces of the lumens 110a-110c and capillaries 118a and 118b, the outer surfaces of the capillaries 118a and 118b, the outer surface of the catheter body 104, etc.) can be smoothed to impede or further reduce the likelihood of bubble formation by nucleation. In some implementations, one or more of the surfaces can be coated or pre-wetted with a liquid and / or a hydrophilizing agent or coating (e.g., saline, ethanol, benzalkonium heparin, blood proteins, etc.) prior to use to further inhibit bubble formation by nucleation.

[0132] 1A and 1B, the lumen 110a extends centrally through the catheter body 104 and along the longitudinal axis 106. However, this need not always be the case. For example, Figures 2A and 2B show perspective and front views, respectively, of another exemplary catheter 102. In this example, the lumen 110a is disposed off-center along the catheter body 104 such that it extends parallel to the longitudinal axis (rather than along the longitudinal axis 106).

[0133] Further, in the example shown in Figures 1A and 1B, the catheter 102 includes two lumens 110b and 110c and two capillaries 118a and 118b for conveying the gas-enriched liquid into the patient's vascular system. However, that need not always be the case. For example, Figures 3A and 3B show perspective and front views, respectively, of another exemplary catheter 102. In this example, the catheter 102 includes three lumens 110b-110d extending through the catheter body 104, each configured to convey the gas-enriched liquid into the patient's vascular system. Further, the catheter 102 includes three capillaries 118a-118c extending from and in fluid communication with the lumens 110b-110d, respectively. During an exemplary use of system 100, gas-enriched liquid source 150 and pump 152 are attached to catheter 102 such that gas-enriched liquid source 150 and pump 152 are in fluid communication with the input openings of each of lumens 110b-110d. Additionally, pump 152 is actuated such that it draws gas-enriched liquid from gas-enriched liquid source 150 and pumps the gas-enriched liquid into each of lumens 110b-110d. The gas-enriched liquid flows through lumens 110b-110d into capillaries 118a-118c and exits capillaries 118a-118c as three respective streams.

[0134] Additionally, the capillaries 118a-118c are configured such that the flows mix at a mixing region within the patient's vasculature. For example, the capillaries 118a-118c may define respective paths that are angled relative to the longitudinal axis 106, such that the flows exit the capillaries 118a-118c at respective angles relative to the longitudinal axis 106. In some implementations, the capillaries 118a-118c may be configured such that at least two of the flows intersect at a point some distance beyond the tip of the catheter 102. In some implementations, the capillaries 118a-118c may be configured such that all of the flows intersect at a point some distance beyond the tip of the catheter 102 (e.g., at a point on the longitudinal axis 106).

[0135] 3A and 3B show an exemplary catheter having three lumens and three capillaries for transporting gas-enriched liquid and are merely illustrative examples. In practice, the catheter can include any number of lumens and capillaries for transporting gas-enriched liquid. As an example, the catheter can include one, two, three, four, or more lumens for transporting gas-enriched liquid. As another example, the catheter can include one, two, three, four, or more capillaries for transporting gas-enriched liquid.

[0136] In some implementations, the catheter may have multiple lumens connected to multiple capillaries. For example, although not shown in the figures, the catheter may include a single capillary and multiple lumens, some of which may converge and connect to a single capillary, and others of which may serve as communicating lumens to at least one of receive a sample of the patient's blood from the patient's vasculature or measure a parameter of the patient's blood. The flow may exit the single capillary output opening without crossing the vessel wall and mix the blood without forming air bubbles at a distance downstream from the capillary output opening. A single capillary catheter may also be utilized to indicate where air bubble formation is less of a concern, for example, where blood flow does not go to the heart or brain but is instead pushed against the capillary bed or the patient's tissue, or when to target venous blood flow.

[0137] Additionally, while the exemplary catheters described above each have a single lumen to facilitate measuring one or more characteristics of the patient's blood within the patient's vasculature and / or to facilitate collecting a blood sample from the patient's vasculature, this need not always be the case. Indeed, a catheter can have any number of lumens (e.g., one, two, three, four, or more) to facilitate measuring one or more characteristics of the patient's blood within the patient's vasculature and / or to facilitate collecting a blood sample from the patient's vasculature.

[0138] As shown in Figures 3A-3B, the capillaries 118a-118c may be configured such that all or two or more of the flows ejected by the capillaries 118a-118c intersect at a point along the longitudinal axis 106 beyond the tip of the catheter 102. For example, as shown in Figure 3B, in cross section, each of the capillaries 118a-118c may extend radially from the longitudinal axis 106. However, this need not always be the case. For example, Figures 4A and 4B show perspective and front views, respectively, of another exemplary catheter 102. In this example, each of the capillaries 118a-118c does not extend radially from the longitudinal axis 106 in cross section. Instead, in cross section, each of the capillaries 118a-118c is offset relative to their respective radii at a particular angle such that the flows ejected by the capillaries 118a-118c interact at a point that is not on the longitudinal axis 106. This may be beneficial, for example, to facilitate mixing of the patient's blood and the gas-enriched liquid in a spiral or vortex pattern, which may further inhibit, reduce, or prevent the formation of bubbles. Having angled capillaries may generate angular momentum that causes mixing by rotation, which may result in improved overall mixing. In certain instances, the capillaries may be offset or angled at angles ranging from greater than 0 degrees to 15 degrees relative to one another. Typically, the longitudinal direction of the catheter may be considered relative to the axial direction of the catheter. Additionally, the lateral direction of the catheter may be considered relative to the radial direction of the catheter.

[0139] In some implementations, the system 100 may also include a self-centering feature for positioning the catheter 102 within the patient's vasculature (e.g., so that the capillaries of the catheter body 104 and / or the flow discharged by the capillaries are centered in the vein or artery, away from the vessel walls and impeding the flow from impinging on the vessel walls, thereby reducing or impeding nucleation or bubble formation). For example, FIG. 5A shows an exemplary catheter 102 including an inflated balloon structure 502. The balloon structure 502 surrounds a portion of the catheter 104 and may be selectively inflated and deflated. For example, after a portion of the catheter 102 is inserted into the blood vessel 160, the balloon structure 502 may be inflated so that it contacts the wall of the blood vessel 160. In this configuration, the body of the catheter 104 is centered within the blood vessel 160. In response, the flow of gas-enriched liquid discharged by the capillaries 118a and 118b mixes in a mixing region away from the wall of the blood vessel 160. This can be beneficial, for example, in reducing mechanical stress on the vessel wall and further inhibiting, preventing or reducing the formation of air bubbles.

[0140] As another example, FIG. 5B illustrates an exemplary catheter 102 that includes an expandable mesh structure 504. The mesh structure 504 surrounds a portion of the catheter 104 and can be selectively expanded and collapsed. For example, after a portion of the catheter 102 is inserted into a blood vessel 160, the mesh structure 504 can expand so that it contacts the wall of the blood vessel 160. In this configuration, the body of the catheter 104 is centrally positioned inside the blood vessel 150. Accordingly, the streams of gas-enriched liquid discharged by the capillaries 118a and 118b mix in a mixing region away from the wall of the blood vessel 160. As explained above, this can be beneficial, for example, in reducing mechanical stress on the blood vessel wall and further inhibiting, preventing, or reducing the formation of gas bubbles.

[0141] As described above, the capillaries of the catheter may be configured such that the streams of gas-enriched liquid discharged by the capillaries mix at a mixing region within the patient's vasculature. For example, the capillaries may define respective paths that are angled relative to the longitudinal axis of the catheter, such that the streams exit the capillaries at respective angles relative to the longitudinal axis 106. In some implementations, the angle may be between 10 degrees and 80 degrees, or between 15 degrees and 75 degrees.

[0142] In some implementations, this angle may be selectively adjusted. For example, one or more of the capillaries may include a flexible portion or hinge that can be selectively bent or curved (e.g., to selectively increase or decrease the angle). This may be beneficial, for example, in allowing a user to adjust the distance between the mixing region and the end of the catheter.

[0143] For example, as shown in FIG. 6A, the catheter 102 may include two capillaries 118a and 118b (e.g., as described in conjunction with FIG. 1A and FIG. 1B). Additionally, the capillaries 118a and 118b may define respective paths that are angled at a first angle 602a with respect to the longitudinal axis 106 of the catheter 102, such that flow exits the capillaries at the first angle 602a with respect to the longitudinal axis 106. For example, the capillaries 118a and 118b may define respective paths that are angled at an angle 602a with respect to the longitudinal axis 106 of the catheter 102 that is approximately 45 degrees. In this configuration, the flow exited by the capillaries 118a and 118b intersect at a first point 604a beyond the tip of the catheter 102.

[0144] Further, as shown in FIG. 6B, the capillaries 118a and 118b can be adjusted to define respective paths angled at a second angle 602b with respect to the longitudinal axis 106 of the catheter 102, the second angle 602b being greater than the first angle 602a. Accordingly, the flow is discharged from the capillaries according to the second angle 602b with respect to the longitudinal axis 106. For example, the capillaries 118a and 118b can define respective paths angled at a second angle 602b with respect to the longitudinal axis 106 of the catheter 102, the second angle 602b being approximately 60 degrees. In this configuration, the flow discharged by the capillaries 118a and 118b intersect at a second point 604b beyond the tip of the catheter 102. As shown in FIG. 6B, the distance between the second point 604b and the tip of the catheter 102 is smaller than the distance between the first point 604a and the tip of the catheter 102.

[0145] Further, as shown in FIG. 6C, the capillaries 118a and 118b can be adjusted to define respective paths angled at a third angle 602c with respect to the longitudinal axis 106 of the catheter 102, the third angle 602c being smaller than the first angle 602a. Accordingly, the flow is discharged from the capillaries according to the third angle 602c with respect to the longitudinal axis 106. For example, the capillaries 118a and 118b can define respective paths angled at a third angle 602c with respect to the longitudinal axis 106 of the catheter 102, the third angle 602c being about 30 degrees. In this configuration, the flow discharged by the capillaries 118a and 118b intersect at a third point 604c beyond the tip of the catheter 102. As shown in FIG. 6C, the distance between the third point 604c and the tip of the catheter 102 is greater than the distance between the first point 604a and the tip of the catheter 102.

[0146] In some implementations, the catheter 102 may include features that allow a user to determine the orientation of the capillaries when in a patient's body. For example, the capillaries 118a and 118b may include fiducial markings or structures that allow for manipulation or movement of the capillaries. For example, the structures may include wires or other mechanisms coupled to the capillaries through the catheter to allow for manipulation or bending of the capillaries. Bendable capillaries may allow a user to angle or change the path of the flow of each jet relative to the longitudinal axis 106 of the catheter 102. Additionally, fiducial markings on the capillaries may be used to position or guide the capillaries. The fiducial markings may be at least partially composed of a radiopaque material (e.g., a metal or metal alloy) such that the orientation of the fiducial markings may be determined using a medical imaging system (e.g., an x-ray imaging system). For example, the fiducial markings may include radiopaque markers 608a and 608b, shown in FIG. 6A, disposed on capillaries 118a and 118b, respectively.

[0147] 7A shows another exemplary system 700 for enriching bodily fluids with gas-enriched liquid inside an enclosed region of the body. By way of example, system 100 may be used to enrich a patient's blood with supersaturated oxygen-enriched liquid within the patient's vasculature.

[0148] 7A, system 700 includes a catheter 702, a gas-enriched liquid source 150, and a pump 152. Catheter 702 is configured for insertion into a patient's vascular system and configured to facilitate delivery of gas-enriched liquid (e.g., from gas-enriched liquid source 150) via pump 152 to the patient's vascular system.

[0149] The catheter 102 includes an elongated tubular catheter body 704 having a coil portion 706 (shown in more detail in FIG. 7B). Additionally, the coil portion 706 defines multiple output apertures 708 along at least a portion of its length. In some implementations, at least a portion of the catheter 702 and / or catheter body 704 may be constructed of polycarbonate, glass, ceramic, stainless steel, PEEK, and / or polyimide. In some implementations, the catheter body 174 may have an outer diameter ranging from 4F to 12F, or, for example, from 4F to 5F (according to the French scale). In some implementations, the catheter body 174 may have an inner diameter ranging from 0.020 inches to 0.045 inches (about 0.5 mm to about 1.1 mm).

[0150] 7C shows a cross-sectional view of the coil portion 706. As shown in FIG. 7C, the catheter body 704 includes a tubular wall 710 (e.g., having a circular, elliptical, or oval cross-section) that defines a lumen 712. Additionally, each of the output openings 708 extends through the wall 710 such that a fluid path extends from the lumen 712 to the surrounding environment. In some implementations, the catheter 702 can extend axially and at least some of the output openings 708 can fan one or more radial directions perpendicular to the axial direction (e.g., such that a flow of gas-enriched liquid exits the catheter 702 in a direction perpendicular to the flow of blood in the patient's vasculature).

[0151] During an exemplary use of the system 700, the gas-enriched liquid source 150 and the pump 152 are attached to the catheter 702 such that the gas-enriched liquid source 150 and the pump 152 are in fluid communication with the lumen 712. By way of example, one or more fluid-tight tubes may be used to transport the gas-enriched liquid from the gas-enriched liquid source 150 to the pump 152, and from the pump 152 to the input opening 714 of the catheter 702. In some implementations, the tubes may be secured to the input opening 714 using fittings or connectors, such as high pressure Luer fittings.

[0152] Further, a portion of the catheter 702 is inserted into the patient, e.g., the coil portion 706 of the catheter body 704 is disposed within the patient's vascular system (e.g., a blood vessel 160, e.g., a vein or artery). After the catheter 702 is inserted into the patient, the pump 152 is actuated such that it draws gas-enriched liquid from the gas-enriched liquid source 150 and pumps the gas-enriched liquid into the lumen 712. The gas-enriched liquid flows through the lumen 712 as respective streams 716 and is discharged from the output opening 708 into the blood vessel 160, where it mixes with the blood. This configuration may be beneficial, for example, in providing the gas-enriched liquid into the patient's blood in a diffusive manner, thereby eliminating or otherwise reducing the formation of gas bubbles within the patient's vascular system.

[0153] 7A and 7B show an example configuration of coil portion 706 having four coils, but this is merely an illustrative example. In practice, coil portion 706 may have any number of coils (e.g., 1, 2, 3, 4, 5, or more). Additionally, coil portion 706 may have any number of output apertures 708 (e.g., 1, 2, 3, 4, 5, or more).

[0154] In some implementations, one or more of the coils of the coil portion 706 can have a helical or spiral shape (e.g., have a variable diameter). In some implementations, the coils in the coil portion 706 can repeat according to a periodic pattern. In some implementations, the elongated tubular catheter body can be substantially straight, without any coils or helical portions.

[0155] In some implementations, at least some of the output apertures 708 may be periodically distributed along at least a portion of the catheter body 704. In some implementations, adjacent output apertures 708 may be separated from one another by at least a certain minimum distance. The minimum distance may depend on the jet penetration of each flow exiting the output aperture 708 (e.g., the flow rate of the gas-enriched liquid and / or the diameter of the output aperture 708). The output apertures may be separated or spaced apart such that the jet penetration dissipates before reaching an adjacent output aperture or output aperture branch to prevent or reduce nucleation or bubble formation. For example, if the jet penetration is high order, the minimum spacing may be longer. As another example, if the jet penetration is low order, the minimum spacing may be shorter. This may be beneficial, for example, in further preventing or reducing the likelihood of bubble formation due to nucleation. Exemplary ranges of minimum spacing distances between output apertures include 1 cm to 5 cm from aperture center to aperture center, either around the circumference or along the longitudinal axis of the catheter. In some implementations, adjacent openings 708 can be offset or spaced along the catheter body 704 from one another by a distance ranging from 1 cm to 5 cm.

[0156] In some implementations, at least a portion of the catheter 702 may be flexible. This may be beneficial, for example, in facilitating insertion and placement of the catheter 702 within a patient's body. By way of example, as shown in FIG. 8A, a guide rod 718 may be inserted into the lumen 712 of the catheter 702 and pushed toward the coiled portion 706. As shown in FIG. 8B, the guide rod 718 may be pushed through at least a portion of the coiled portion 706 such that the coiled portion 706 is at least partially straight. In this configuration, the catheter 702 may be more easily inserted into a patient's blood vessel. Upon inserting the catheter 702 into a patient's blood vessel, the guide rod 718 may be retracted from the catheter 702. In some implementations, the catheter 702 may be at least partially constructed of a shape memory material such that the coiled portion 706 returns to its coiled shape when the guide rod 718 is retracted.

[0157] 7A-7C, the catheter 702 includes multiple output apertures 708 in fluid communication with the surrounding environment and the lumen 712 of the catheter body 704. However, in some implementations, the catheter 702 may further include one or more tubular structures to further increase diffusivity, whereby the gas-enriched liquid is discharged into the patient's vasculature. For example, as shown in FIG. 9A, the catheter 702 may include one or more branched tubular structures 902, each configured to receive the gas-enriched liquid from the lumen 712 and discharge the gas-enriched liquid as a respective stream 904 into the patient's vasculature.

[0158] 9B, the catheter 702 can include one or more non-branched tubular structures 906, each configured to receive gas-enriched liquid from the lumen 712 and discharge the gas-enriched liquid as a respective stream 908 into the patient's vasculature. In some implementations, the catheter can include both branched and non-branched tubular structures. The tubular structures can be offset or spaced apart from one another along the longitudinal axis of the catheter to prevent the stream from a first tubular structure from intersecting a surface of a second tubular structure, thereby reducing or preventing bubble formation or nucleation.

[0159] In general, the catheter 702 shown in FIGS. 9A and 9B may be similar to one or more of the other catheters described above (e.g., the catheter 702 described with reference to FIGS. 7A-7C). For example, the catheter 702 shown in FIGS. 9A and 9B may have an inner diameter ranging from 0.020 inches to 0.045 inches (about 0.5 mm to about 1.1 mm) and / or an outer diameter ranging from 4F to 12F (about 1.33 mm to 4 mm). Additionally, the catheter 702 shown in FIGS. 9A and 9B may include one or more fiducial markings. Additionally, one or more fluid-tight tubes may be used to convey the gas-enriched liquid from the gas-enriched liquid source (e.g., the gas-enriched liquid source 150) to the pump (e.g., the pump 152) and from the pump to the input opening of the catheter 702. In some implementations, the tube may be secured to the input opening using a fitting or connector, such as a high pressure Luer fitting.

[0160] In some implementations, at least some of the tubular structures 902 and / or 906 may be sized to be the same as another of the tubular structures. In some implementations, at least some of the tubular structures 902 and / or 906 may be sized differently than another of the tubular structures. In some implementations, at least some of the tubular structures 902 and / or 906 may have an inner diameter ranging from 40 microns to 100 microns. Additionally, at least some of the tubular structures 902 and / or 906 may have an outer diameter ranging from 140 microns to 400 microns. In some implementations, adjacent tubular structures 902 and / or 906 may differ in length from one another by a length ranging from 1 cm to 5 cm. In some implementations, adjacent tubular structures may be offset or spaced apart from one another along the catheter body by a distance ranging from 1 cm to 5 cm.

[0161] While the present specification contains many details, these should not be construed as limiting the scope of what may be claimed, but rather as descriptions of features specific to particular examples. Certain features that are described in the context of separate implementations herein may also be combined. Conversely, various features that are described in the context of a single implementation may also be implemented in multiple embodiments separately or in any suitable subcombination.

[0162] Although multiple embodiments have been described, various modifications can be made without departing from the spirit and scope of the invention. Accordingly, other embodiments are within the scope of the following claims.

Claims

1. 1. A catheter configured for insertion into a patient's vascular system, the catheter comprising: A catheter body; a first lumen extending through the catheter body, the first lumen configured to be in fluid communication with the patient's vascular system when the catheter is inserted into the patient's vascular system, the first lumen configured to at least one of receive a sample of blood from the patient's vascular system or measure a parameter of the patient's blood; one or more second lumens extending through the catheter body, the one or more second lumens configured to receive gas-enriched liquid from a gas-enriched liquid source; two or more capillary tubes extending from the catheter body and coupled to the one or more second lumens; each of the two or more capillaries in fluid communication with the one or more second lumens and in fluid communication with the vascular system of the patient when the catheter is inserted into the vascular system of the patient; each of the two or more capillaries is configured to receive the gas-enriched liquid from the one or more second lumens and simultaneously distribute a respective stream of the gas-enriched liquid directly into the vascular system of the patient; the catheter body is configured to position the two or more capillaries at one or more predetermined angles relative to one another such that the flow of the gas-enriched liquid intersects and mixes with the patient's blood in a region beyond an end of the catheter body and beyond the first lumen; catheter.

2. The catheter of claim 1 , further comprising a pressure sensor disposed within the first lumen, the pressure sensor configured to obtain one or more pressure measurements.

3. The parameters of the patient's blood include: the partial pressure of oxygen in the patient's blood; The patient's blood SO ２ , the patient's blood pressure; the flow rate of the patient's blood; or The temperature of the patient's blood The catheter according to claim 1 or 2, wherein the catheter is at least one of:

4. The catheter, 4. The catheter of claim 1, further comprising a third lumen extending through the catheter body, the third lumen configured to be in fluid communication with the patient's vascular system when the catheter is inserted into the patient's vascular system, the third lumen configured to perform at least one of receiving an additional sample of the patient's blood from the patient's vascular system and / or measuring an additional parameter of the patient's blood.

5. 5. The catheter of claim 1, wherein the catheter body is configured to position the two or more capillaries such that the flow of the gas-enriched liquid does not intersect with a longitudinal axis extending through a center of the catheter.

6. 6. The catheter of claim 1, further comprising one or more shields or guards disposed over a distal opening of the first lumen and configured to reduce nucleation along one or more surfaces of the catheter.

7. The catheter of claim 1 , wherein at least one capillary comprises a fiducial marking.

8. 8. The catheter of claim 1, further comprising one or more sensors, the one or more sensors configured to be in fluid communication with the patient's vascular system when the catheter is inserted into the patient's vascular system.

9. At least one of the one or more sensors measures partial oxygen pressure (pO ２ 9. The catheter of claim 8, wherein the sensor is a

10. The catheter of claim 1 , further comprising a self-centering device configured to center the catheter body within the vasculature of the patient.

11. A catheter body; a first lumen extending through the catheter body, the first lumen configured to be in fluid communication with the patient's vascular system when the catheter body is inserted into the patient's vascular system, the first lumen configured to at least one of receive a sample of blood from the patient's vascular system or measure a parameter of the patient's blood; one or more second lumens extending through the catheter body, the one or more second lumens configured to receive gas-enriched liquid from a gas-enriched liquid source; two or more capillary tubes extending from the catheter body and coupled to the one or more second lumens; each of the two or more capillaries is in fluid communication with the one or more second lumens and is configured to be in fluid communication with the patient's vascular system when the catheter body is inserted into the patient's vascular system; each of the two or more capillaries is configured to receive the gas-enriched liquid from the one or more second lumens and simultaneously distribute a respective stream of the gas-enriched liquid directly into the vascular system of the patient; the catheter body is configured to position the two or more capillaries at one or more predetermined angles relative to one another such that the flow of the gas-enriched liquid intersects and mixes with the patient's blood in a region beyond an end of the catheter body and beyond the first lumen; a fluid dispensing device in fluid communication with the one or more second lumens, the fluid dispensing device having one or more pumps configured to supply the gas-enriched liquid to the one or more second lumens. system.

12. 12. The system of claim 11, further comprising one or more connectors configured to couple the one or more second lumens to one or more respective dispense ports of the fluid dispense device.

13. 13. The system of claim 11 or 12, wherein the gas-enriched liquid comprises one or more of oxygen, ozone, an inert gas, nitrogen, nitrous oxide, carbon dioxide or air.

14. A catheter body; a first lumen extending through the catheter body, the first lumen configured to be in fluid communication with the patient's vascular system when the catheter body is inserted into the patient's vascular system, the first lumen configured to at least one of receive a sample of blood from the patient's vascular system or measure a parameter of the patient's blood; one or more second lumens extending through the catheter body, the one or more second lumens configured to receive gas-enriched liquid from a gas-enriched liquid source; two or more capillary tubes extending from the catheter body and coupled to the one or more second lumens; each of the two or more capillaries is in fluid communication with the one or more second lumens and is configured to be in fluid communication with the patient's vascular system when the catheter body is inserted into the patient's vascular system; each of the two or more capillaries is configured to receive the gas-enriched liquid from the one or more second lumens and simultaneously distribute a respective stream of the gas-enriched liquid directly into the vascular system of the patient; the catheter body is configured to position the two or more capillaries at one or more predetermined angles relative to one another such that the flow of the gas-enriched liquid intersects and mixes with the patient's blood in a region beyond an end of the catheter body and beyond the first lumen; and a blood sampling device in fluid communication with the first lumen, the blood sampling device configured to draw the sample of the patient's blood from the patient's vascular system through the first lumen. system.

15. The system of claim 11 , further comprising a pressure sensor disposed within the first lumen, the pressure sensor configured to obtain one or more pressure measurements.

16. The parameters of the patient's blood include: the partial pressure of oxygen in the patient's blood; The patient's blood SO ２ , the patient's blood pressure; the flow rate of the patient's blood; or The temperature of the patient's blood The system of claim 11 , wherein the at least one of

17. The catheter body includes:

12. The system of claim 11, comprising: a third lumen extending through the catheter body, the third lumen configured to be in fluid communication with the patient's vascular system when the catheter body is inserted into the patient's vascular system, the third lumen configured to at least one of receive an additional sample of the patient's blood from the patient's vascular system or measure an additional parameter of the patient's blood.

18. 12. The system of claim 11, further comprising one or more sensors, the one or more sensors configured to be in fluid communication with the patient's vascular system when the catheter body is inserted into the patient's vascular system.

19. The parameters of the patient's blood include: the partial pressure of oxygen in the patient's blood; The patient's blood SO ２ , the patient's blood pressure; the flow rate of the patient's blood; or The temperature of the patient's blood The system of claim 14, wherein the at least one of

20. 15. The system of claim 14, further comprising one or more sensors, the one or more sensors configured to be in fluid communication with the patient's vascular system when the catheter body is inserted into the patient's vascular system.

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