Catheter insert including one or more sensors

Abstract

In some instances, a device includes an elongated catheter insert body defining a body lumen, the elongated catheter insert body being configured to be at least partially inserted into a catheter lumen defined by a catheter without covering a first fluid opening of the catheter and forming a fluid-tight connection with the catheter, and one or more sensors positioned on the elongated body. At least one of the one or more sensors is configured to sense a substance of interest. The elongated catheter insert body comprises a material that is substantially impermeable to the substance of interest.

Description

[0001] This application claims priority to U.S. patent application No. 16 / 840,150, entitled “CATHETER INSERTINCLUDING ONE OR MORE SENSORS,” filed on April 3, 2020, which claims the benefit of U.S. provisional patent application No. 62 / 952,776, entitled “CATHETER INCLUDING A PLURALITY OF SENSORS,” filed on December 23, 2019. Technical Field

[0002] The present disclosure relates to medical devices, and more particularly to catheters. Background Art

[0003] Medical devices, such as catheters, can be used to help patients urinate. In some cases, such catheters may be used during and / or after surgery. In cases where a catheter is used to help a patient urinate, a Foley catheter is a type of catheter that can be used for longer periods of time than a non-Foley catheter. Some Foley catheters are constructed of silicone rubber and include an anchoring member, which may be an inflatable balloon that can be inflated in the patient's bladder to act as an anchor so that the proximal tip of the catheter does not slip out of the patient's bladder. Summary of the Invention

[0004] In general, the present disclosure describes a medical device, such as an insert for a catheter (e.g., a Foley catheter). The medical device includes an elongated body configured to be at least partially inserted into a lumen of the catheter, and one or more sensors positioned on the elongated body. In some instances, the medical device is configured to be inserted into the drainage lumen of the Foley catheter such that the proximal end of the medical device is adjacent to, but does not cover, an eyelet, drainage opening, or other means of entry into the drainage lumen of the catheter from the patient's bladder, thereby allowing urine to flow from the patient's bladder into the Foley catheter and through the medical device. In some instances, the medical device is configured to be inserted into the drainage lumen of the Foley catheter such that the distal end is outside the drainage lumen of the Foley catheter. In some examples, the distal tip of the medical device may form a funnel or include a connector for connecting to a fluid collection container, such as a urine bag, wherein the funnel or connector is configured to prevent the medical device from being inserted so far into the drainage lumen of the Foley catheter that the proximal tip of the medical device would cover the eyelet, drainage opening, or other entry means for urine to enter the drainage lumen of the Foley catheter from the patient's bladder.

[0005] In some instances, at least one of the one or more sensors may be placed on the distal portion of the medical device. As used herein, distal is defined in Section 3.1.4 of ASTM F623-19, Standard Performance Specification for Foley Catheters. That is, the proximal end of the medical device is the end closest to the patient. Thus, the distal end is the end farthest from the patient. The one or more sensors located in the distal portion may be configured to sense one or more substances of interest, and a portion or the entire elongated body of the medical device may comprise a material that is substantially impermeable (e.g., impermeable or nearly impermeable) to the substances of interest to help minimize loss and / or contamination of the substances of interest as fluid containing the substances of interest propagates through the lumen of the elongated body of the medical device to the one or more sensors located in the distal portion. In this way, the medical device is configured so that the sensors are able to sense substances of interest despite being positioned relatively far from a fluid source (e.g., the bladder). As used herein, "sensing" may include "detecting" and / or "measuring."

[0006] In one instance, the present disclosure relates to a device comprising an elongated body defining a body lumen, the elongated body being configured to be at least partially inserted proximally into a catheter lumen defined by a catheter without covering a proximal fluid opening of the catheter and forming a fluid-tight connection with the catheter, and one or more sensors positioned on the elongated body, at least one of the one or more sensors being configured to sense a substance of interest in the fluid within the body lumen, wherein the elongated body comprises a material that is substantially impermeable to the substance of interest.

[0007] In another example, the present disclosure is directed to an assembly comprising: a Foley catheter including an elongated catheter body defining a drainage lumen, the elongated catheter body including a catheter distal portion and a catheter proximal portion, the catheter proximal portion defining a first drainage opening for fluidly coupling to the drainage lumen, and the catheter distal portion defining a second drainage opening for fluidly coupling to the drainage lumen; and a catheter inserter including: an elongated catheter inserter body defining a body lumen, the elongated catheter inserter body including a first body distal portion, a second body distal portion, and a body proximal portion, the body proximal portion defining a first body fluid opening for fluidly coupling to the body lumen, and the first body distal portion The catheter inserter elongated body comprises a second body fluid opening defined by a fluid connection to the body lumen, wherein the catheter inserter elongated body is configured such that when the first body distal portion is connected to the Foley catheter and the second body distal portion and the body proximal portion are inserted into the drainage lumen, the proximal end of the catheter inserter elongated body remains distal to the first drainage opening of the Foley catheter; and one or more sensors positioned on the catheter inserter elongated body, at least one of the one or more sensors being configured to sense a substance of interest, wherein the catheter inserter elongated body comprises a material that is substantially impermeable to the substance of interest, the material extending from the first body fluid opening to the at least one of the one or more sensors.

[0008] In another example, the present disclosure relates to a method comprising: introducing a proximal end of a catheter insert into a lumen of a catheter, the catheter insert comprising an elongated body defining a main lumen and one or more sensors positioned on the elongated body, at least one of the one or more sensors being configured to sense a substance of interest in a fluid within the main lumen, wherein the elongated body comprises a material that is substantially impermeable to the substance of interest; advancing the catheter insert proximally into the drainage lumen so that the proximal end of the catheter insert is proximal to an anchoring member of the catheter and distal to a proximal fluid opening of the catheter; and fluidly coupling the catheter insert and the catheter.

[0009] The details of one or more examples are set forth in the accompanying drawings and the description below. Other features, objects, and advantages will be apparent from the description and drawings, and from the claims. BRIEF DESCRIPTION OF THE DRAWINGS

[0010] Figure 1 A diagram illustrating an example Foley catheter.

[0011] Figure 2 A diagram illustrating an example medical device configured for insertion into a Foley catheter.

[0012] Figure 3 To illustrate the Figure 2 Diagram of a Foley catheter, an example medical device.

[0013] Figures 4A-4C To illustrate the use of a medical device inserted into a Foley catheter Figure 3 Figure 2 is a diagram of a cross-sectional view of an example of a medical device and a Foley catheter, the cross section being taken along Figure 3 The line 2-2 is intercepted.

[0014] Figure 5 A flow chart illustrating an example method of operating a medical device.

[0015] Figure 6 is a block diagram of an example external device that may be used with a medical device. DETAILED DESCRIPTION

[0016] Acute kidney injury (AKI) is a complication that can occur after some medical procedures, such as some heart surgeries, for example, coronary artery bypass grafting (CABG). AKI can also occur after other surgeries that are prolonged and involve a large amount of blood loss or fluid shifts. For example, a surgical patient's body may change the direction of their blood flow, which can cause the kidneys to be deprived of oxygen. One cause of surgery-related AKI is a lack of oxygen to the kidneys, which can lead to an inflammatory response in the patient's kidneys. This inflammatory response can cause the patient's kidney function to deteriorate. The deterioration of kidney function can lead to a buildup of waste products in the blood, which can delay the patient's recovery from surgery and lead to a longer hospital stay, and can even lead to further complications.

[0017] While systemic vital signs such as cardiac output, blood pressure, and hematocrit can help monitor these functions, it is also useful to monitor the oxygenation status of the kidneys to limit or even prevent the risk of AKI. Accurate monitoring of renal oxygenation can be challenging due to the inaccessibility of the kidneys. Near-infrared spectroscopy (NIRS) measures regional oxygen saturation and has some utility in measuring renal oxygenation in infants and relatively slender adults, but may not have the penetration depth and specificity required in some patients.

[0018] The present disclosure describes an example medical device that is configured to monitor the renal function of a patient, such as a patient who is undergoing or has undergone surgery, which can help reduce the occurrence of AKI. The medical device includes at least one sensor that is configured to sense the parameters of a fluid of interest, such as urine in the case of renal function monitoring. Although urine, bladder, and AKI are primarily mentioned herein to describe the example medical device, in other examples, the medical device can be used together with other target locations (such as intravascular locations) in the patient's body and monitor the fluid of interest other than urine and / or other patient conditions other than renal function. As discussed in further detail below, in some examples, the example medical device includes an oxygen sensor that is configured to sense the amount of oxygen dissolved in urine in the bladder (e.g., oxygen tension or uPO2 or PuO2) and / or sense urine volume (e.g., urine production rate), and a clinician or device can determine the oxygenation state of one or more kidneys of a patient from the oxygen sensor.

[0019] Example parameters of interest sensed by the sensors described herein include, but are not limited to, any one or more of the following: amount of dissolved oxygen, urine concentration, urine conductivity, urine specific gravity, urine biomarkers, amount of dissolved carbon dioxide in urine, urine pH, bladder or abdominal pressure, bladder temperature, urine color, urine creatinine, or motion from an accelerometer or other motion sensor. In some cases, it may be desirable to sense one or more of these parameters as close to the kidney as possible because when the sensor is positioned away from the kidney, there is an increased risk of introducing noise or losing signal strength and / or an increased risk of changes in the concentration or integrity of the substance of interest in the fluid of interest before being sensed by the sensor. For example, an electrical, optical, or radio frequency signal representing a parameter sensed near the kidney may be affected by noise and / or signal strength loss as the signal propagates from the sensor near the kidney to a device that can process the signal and display information about the sensed parameter. For example, in the case of a Foley catheter, it may be desirable to sense one or more of these parameters at the proximal end of the Foley catheter (e.g., in the patient's bladder). However, placing these sensors at the proximal end of the catheter can increase the size and stiffness of the catheter and, therefore, can compromise patient comfort or the catheter's delivery capabilities. By design, the Foley catheter is made small and flexible so that it can be inserted through the urethra and into the patient's bladder. If the Foley catheter were stiffer, it might be more difficult to comfortably insert the catheter into the patient's bladder.

[0020] The amount of dissolved oxygen in a patient's urine can indicate kidney function or kidney health. For example, the amount of dissolved oxygen in a patient's urine in the bladder can be correlated with the perfusion and / or oxygenation of the kidneys, which is indicative of kidney performance. However, dissolved oxygen can be relatively difficult to measure. One way to measure dissolved oxygen is through a fluorescence or luminescence lifetime sensor. The decay of the glow indicates the oxygen level in the patient's urine. In order to accurately measure the oxygen level in a patient's urine, it may be necessary to take the measurement before any significant change in the oxygen content in the urine occurs, for example, as close to the kidneys as possible. However, placing the dissolved oxygen sensor at the proximal end of the catheter may be impractical because doing so can increase the cost, size, and size of the catheter.

[0021] According to an example of the present disclosure, instead of integrating all desired sensors in a proximal portion such as a catheter (e.g., a portion to be inserted into a patient's bladder or otherwise introduced into a patient's body), or positioning one or more sensors in a distal portion of a catheter, one or more sensors may be positioned at a distal portion of the elongated body of a medical device or distal end of the elongated body, and the medical device is configured to be inserted into a catheter. The medical device may be referred to as a catheter insert. In order to help minimize or even eliminate degradation and / or contamination of a substance of interest in a fluid (e.g., urine) before the fluid reaches the distal portion of the elongated body of the medical device or the sensor distal end of the elongated body of the medical device, a portion or all of the elongated body of the medical device comprises a material that is substantially impermeable (e.g., impermeable or nearly impermeable) to the substance of interest. The medical device described herein may also be referred to as a catheter insert. Although described herein as a catheter insert, in some instances, the medical device may be used together with other devices or on an independent basis.

[0022] Compared to existing Foley catheters or other medical devices that are permeable to many substances of interest, the medical devices described herein, such as catheter inserts, enable sensors to relatively accurately sense substances of interest in a fluid despite being positioned relatively far from a fluid source (e.g., the bladder). For example, some Foley catheters may include an elongated body made of silicone rubber, which is very porous to oxygen. Consequently, using a dissolved oxygen sensor on the distal portion of such a Foley catheter to measure oxygen content in urine can result in erroneous or biased measurements because oxygen can dissipate from the urine through the walls of the Foley catheter as urine travels from the bladder through the drainage lumen of the proximal portion of the catheter to the sensor on the distal portion of the catheter and into the surrounding environment. Oxygen can also permeate through the walls of the Foley catheter as urine travels from the bladder through the drainage lumen of the proximal portion of the catheter to the sensor on the distal portion of the catheter from the surrounding environment. For example, oxygen can dissipate into or permeate other tissues in the urethra and the atmosphere outside the urethra. However, in some examples described herein, the elongated body of a medical device configured to be at least partially inserted into a drainage lumen of a Foley catheter comprises a material that is substantially impermeable to oxygen, such that the amount of oxygen dissipated or permeated through the walls of the medical device and through the walls of a Foley catheter having the inserted medical device is reduced relative to the elongated body of a standard Foley formed solely of silicone rubber.

[0023] In some instances, the catheter inserts described herein may be made entirely of a material that is substantially impermeable to the substance of interest. In other instances, the catheter inserts may be made of multiple materials, at least one of which is substantially impermeable to the substance of interest. In some instances, the catheter inserts may maintain flexibility and be configured to minimize attenuation of the signal of interest, but may remain sufficiently rigid to be inserted into a Foley catheter. Due to the material being substantially impermeable to the substance of interest, the catheter inserts may be stiffer than a standard Foley catheter. Thus, according to the techniques disclosed herein, a standard Foley catheter, which is designed to be relatively flexible, may be inserted into a patient's bladder, and a catheter insert including one or more sensors may be introduced into the drainage lumen of the Foley catheter, enabling sensing of substances of interest relatively distal to the bladder without increasing the stiffness of the Foley catheter. By positioning the sensors in the distal portion of the elongated body of the catheter insert (or distal to the distal end of the elongated body), the sensors may be larger, may rely on relatively more electrical and / or optical connections, and the catheter itself may be smaller and more flexible, compared to positioning all sensors in the proximal portion of the catheter.

[0024] The catheter inserter is configured to be removed from the Foley catheter without removing the Foley catheter from the patient. Thus, the catheter inserter can be introduced into the drainage lumen of the Foley catheter as needed or desired. For example, if a Foley catheter is already in use on a patient and a clinician determines that sensing of a substance of interest in the patient is desirable, the clinician can introduce the catheter inserter into the already used Foley catheter (in place in the patient's bladder) rather than removing the Foley catheter and inserting a sensing Foley catheter to avoid additional discomfort for the patient.

[0025] The catheter insert can be formed by any suitable material, and the material can be selected based on the substance of interest. For example, in some instances, at least one of the materials forming the catheter insert can be a material that is substantially impermeable to the substance of interest, such as oxygen or carbon dioxide. "Substantially impermeable" can refer to being impermeable or impermeable within the scope allowed by manufacturing tolerances, and / or having a permeability that allows the loss and / or increase of the substance of interest through the material (e.g., through the wall of the elongated body comprising the material) to be relatively minimal (e.g., less than or equal to 5% at a flow rate of 10 ml / h). In some instances, the material that is substantially impermeable to the substance of interest extends along the entire length and periphery of the elongated body of the catheter insert. In other instances, the material that is substantially impermeable to the substance of interest is only along a portion of the length of the elongated body and / or only a portion of the inner and / or outer periphery, such as extending only between the proximal portion of the elongated body and the distal end of the sensor position. By using at least one material that is substantially impermeable to the substance of interest to construct the catheter insert, the sensor can be positioned at the distal portion of the catheter insert while providing more accurate sensor measurements when using a standard Foley catheter.

[0026] Any suitable material can be used for the material that is substantially impermeable to the substance of interest, and the material can be selected based on the substance of interest. In "The Permeability Characteristics of Silicone Rubber" by Haibing Zhang, Ph.D. and Andy Cloud, Society for the Advancement of Material and Process Engineering, 2006, Dr. Zhang provides a table describing the oxygen permeability of various materials. 3 *cm / (s*cm 2 *cmHg) as the unit, the oxygen permeability of dimethyl silicone rubber is indicated as 60*10 9 , nylon 6 indicates 0.004*10 9, polyethylene terephthalate (PET) is indicated as 0.0019*10 9 , polytetrafluoroethylene (PTFE) indicates 0.0004*10 9 The permeability of dimethyl silicone rubber to carbon dioxide is indicated as 323. Therefore, silicone rubber tends to be porous to substances of interest in monitoring renal function, while nylon 6, PET, and PTFE tend to be substantially impermeable to substances of interest in monitoring renal function. Foley catheters are typically constructed of latex or silicone rubber because their flexibility, elasticity, ballooning capability, and low cost make them attractive materials.

[0027] In one example, according to the technology of the present disclosure, a catheter insert, such as a catheter insert configured to be inserted into a catheter, such as a Foley catheter, can be constructed of at least one material that is substantially impermeable to a substance of interest, such as, but not limited to, carbon dioxide or oxygen. In some examples, the catheter insert can be made solely of a material that is substantially impermeable to the substance of interest, such as nylon, PET, or PTFE, in some examples, the substance of interest is oxygen. In other examples, the catheter insert can be made in part of a material that is substantially impermeable to the substance of interest. For example, the catheter insert can be made of a relatively thin layer of a material that is substantially impermeable to the substance of interest disposed on another body material. By constructing a catheter insert, such as a catheter insert configured to be inserted into a Foley catheter, of at least one material that is substantially impermeable to the substance of interest, such as nylon, PET, or PTFE, degradation of the substance of interest during transport through the catheter insert and the Foley catheter can be mitigated, or the introduction of contaminants into the fluid in the catheter insert when using a standard Foley catheter can be mitigated. In one example, a relatively thin layer of substantially impermeable material can be placed on the inner surface of a lumen defined by the catheter insert, and the fluid of interest flows from the proximal portion to the distal portion of the catheter insert through the lumen. In another example, in addition to or in place of the inner surface of the lumen, a relatively thin layer of substantially impermeable material can be placed on the outer surface of the catheter insert.

[0028] Certain parameters of urine or other fluids of interest, such as temperature and pressure, are better measured at the proximal portion of the catheter. Measuring temperature at the distal portion can result in relatively inaccurate measurements because urine can undergo heat exchange with the lumen, surrounding tissue, and atmosphere as it travels from the proximal portion of the catheter insert to the distal portion. Measuring pressure at the distal portion can also result in inaccurate measurements because the distal portion can be higher or lower than the abdomen. These problems can be alleviated by measuring temperature and / or pressure at the proximal portion. In some instances, the catheter insert may have one or more sensors located at the proximal portion.

[0029] Thus, it may be desirable to have a catheter insert, such as a catheter insert configured to be inserted into a Foley catheter, having one or more sensors in a proximal portion and a distal portion and comprising a material that is substantially impermeable to the substance of interest. In some instances, the catheter insert may include such sensors. In some instances, the catheter insert may be configured to attach sensors to the catheter insert. In some instances, the material is substantially impermeable to oxygen and / or carbon dioxide. The sensors that may be positioned in the proximal portion may include a temperature sensor and / or a pressure sensor. The sensors that may be positioned in the distal portion may include sensors that sense urine volume (e.g., flow rate or volume), urine concentration, the amount of dissolved oxygen in the urine (oxygen tension or uPO2), the amount of dissolved carbon dioxide in the urine, urine pH, urine color, urine creatinine, and / or motion.

[0030] Figure 1 FIG2 is a conceptual side view of an example Foley catheter 10 including an elongated catheter body 12, a hub 14, and an anchoring member 18. The Foley catheter 10 includes a distal catheter portion 17A and a proximal catheter portion 17B. The distal catheter portion 17A includes the distal tip 12A of the Foley catheter 10 and is intended to be external to the patient's body during use, while the proximal catheter portion 17B includes the proximal tip 12B of the Foley catheter 10 and is intended to be internal to the patient's body during use. For example, the distal catheter portion 17A can remain external to the patient's body when the proximal catheter portion 17B is positioned within the patient's body, e.g., such that the proximal tip 12B of the Foley catheter 10 is within the patient's urethra and bladder.

[0031] The catheter elongate body 12 is a structure (e.g., a tubular structure) extending from a hub 14 to a proximal tip 12B and defining one or more internal lumens. Figure 1 、 2 4A and 4B, the elongated catheter body 12 defines a lumen 34 and a lumen 36 (in Figures 4A-4C ). In some instances, lumen 34 can be a drainage lumen for draining fluid from a target site, such as a bladder. In other instances, lumen 34 can be used for any other suitable purpose, such as delivering a substance or another catheter insert to a target site in a patient's body. Lumen 34 can extend from proximal fluid opening 13 defined by catheter proximal portion 17B of elongated body 12 to distal fluid opening 14A at the distal end of Foley catheter 10, such as defined by hub 14. Both proximal fluid opening 13 and distal fluid opening 14A can be fluidically coupled to lumen 34 such that fluid can flow from one of proximal fluid opening 13 or distal fluid opening 14A through lumen 34 to the other of proximal fluid opening 13 or distal fluid opening 14A. In instances where lumen 34 is a drainage lumen, proximal fluid opening 13 and distal fluid opening 14A can be drainage openings.

[0032] In some examples, the catheter elongated body 12 has a suitable length for entering a patient's bladder through the urethra. The length can be measured along the central longitudinal axis 16 of the catheter elongated body 12. In some examples, the outer diameter of the catheter elongated body 12 can be about 12 French to about 14 French, although other sizes can be used in other examples. The catheter distal portion 17A and the catheter proximal portion 17B can each have any suitable length.

[0033] exist Figure 1 In the example shown, the distal tip 12A of the catheter elongate body 12 is received within the hub 14 and mechanically connected to the hub 14 via adhesive, welding, or another suitable technique or combination of techniques.

[0034] The hub 14 is positioned at the distal end of the catheter elongate body 12 and defines openings (eg, 14A, 14B) through which one or more internal lumens (eg, Figure 4A and 4B The lumen 34 shown is open and, in some instances, closed. Although the hub 14 is Figure 1 14C and 14D (e.g., a "Y-hub"), the hub 14 may have any suitable number of arms, which may depend on the number of inner lumens defined by the catheter elongate body 12. For example, each arm of the hub 14 may be fluidly coupled to a corresponding inner lumen of the catheter elongate body 12. Figure 1 In the example of FIG. 1 , the hub 14 includes a distal fluid opening 14A fluidly coupled to a lumen 34 and a lumen 36 fluidly coupled to the catheter elongate body 12 (at Figures 4A-4C In instances where the anchoring member 18 does not include an expandable balloon, rather than defining a lumen 36, the catheter elongate body 12 may define an inner lumen configured to receive a deployment mechanism (e.g., a pull wire or push wire) for deploying the expandable structural anchoring member 18, and the hub 14 may include distal fluid opening 14A and opening 14B through which a clinician may access the deployment mechanism.

[0035] A fluid collection container (e.g., a urine bag) can be attached to distal fluid opening 14A for collecting urine drained from the patient's bladder. Inflation opening 14B is operable to connect to an inflation device to inflate an anchoring member 18 positioned on the catheter proximal portion 17B of the Foley catheter 10. When not in use, the anchoring member 18 can be uninflated or undeployed. The hub 14 can include connectors, such as connector 15, for connecting to other devices, such as a fluid collection container and an inflation source. In some instances, connector 15 includes a luer-type connector, a threaded connection, or other connector configured to establish a fluid-tight seal with another device. In some instances, the Foley catheter 10 includes a strain relief member 11, which can be part of the hub 14 or can be separate from the hub 14.

[0036] The proximal catheter portion 17B of the Foley catheter 10 includes an anchoring member 18 and a proximal fluid opening 13. The anchoring member 18 may include any suitable structure configured to expand from a relatively low-profile state to an expanded state, wherein the anchoring member 18 can engage with the patient's tissue (e.g., within the bladder) to help secure and prevent the proximal catheter portion 17B from moving out of the patient's body. For example, the anchoring member 18 may include an anchoring balloon or other expandable structure. When inflated or deployed, the anchoring member 18 can function to anchor the Foley catheter 10 to the patient, such as within the patient's bladder. In this way, the portion of the Foley catheter 10 proximal to the anchoring member 18 can prevent it from sliding out of the patient's bladder. The proximal fluid opening 13 can be positioned on the surface of the elongated body 12 between the anchoring member 18 and the proximal end 12B (as shown), or can be positioned at the proximal end 12B, thereby defining an opening at the proximal end of the Foley catheter 10.

[0037] The catheter elongate body 12 can be structurally configured to be relatively flexible, pushable, and relatively resistant to kinking and bending, such that it resists bending when a pushing force is applied to a relatively distal portion of the catheter inserter to advance the elongate body proximally through the urethra into the bladder. Kinking and / or bending of the catheter elongate body 12 can hinder a clinician's efforts to advance the elongate body proximally.

[0038] In some examples, the catheter elongate body 12 is formed of two or more discrete and separate longitudinally extending segments that are mechanically connected to each other, for example, at an axial butt joint. In other examples, the catheter elongate body 12 can have a unitary construction (e.g., formed from one continuous sheet of material, such as extruded to define a seamless body) and can be substantially continuous along the length of the catheter elongate body 12.

[0039] In some examples, at least a portion of the outer surface of the catheter elongated body 12 includes one or more coatings, such as an antimicrobial coating and / or a lubricious coating. The lubricious coating can be configured to reduce static or dynamic friction between the catheter elongated body 12 and the patient's tissue as the catheter elongated body 12 is advanced through the urethra.

[0040] Figure 2 5 is a conceptual side view of an example catheter inserter 50, which includes a catheter inserter elongated body 58 and one of a plurality of sensors 52. Although catheter inserter 50 is primarily described herein as being used with a Foley catheter, in other examples, catheter inserter 50 can be used with other catheters or for other purposes, such as for draining wounds or for intravascular monitoring or medical procedures. Furthermore, in some examples, catheter inserter 50 is configured to sense one or more parameters discussed herein without being introduced into a catheter, such as by being introduced directly into a patient.

[0041] The catheter insert elongated body 58 includes a first body distal portion 60A and a second body distal portion 60B and a body proximal portion 60C. The second body distal portion 60B and the body proximal portion 60C can be configured to be insertable into and / or removable from the lumen of another catheter insert, such as a Foley catheter 10. In some instances, the first body distal portion 60A is configured to remain outside the lumen 34 of the Foley catheter 10 when the second body distal portion 60B and the body proximal portion 60C are inserted into the drainage lumen of the Foley catheter 10. The first body distal portion 60A includes a body distal end 64 of the catheter insert elongated body 58. In some instances, the first body distal portion 60A is configured to facilitate the inlet or outlet of fluid from a lumen defined by the catheter insert elongated body 58. For example, the first body distal portion 60A may include a connector 70, such as at the distal-most end of the catheter insert 50, which is configured to define a fluid-tight seal with the Foley catheter 10 to help prevent fluid from the lumen 34 of the Foley catheter 10 from flowing out of the lumen 34 between any gap defined between the catheter insert 50 and the Foley catheter 10 when the catheter insert 50 is introduced into the lumen 34.

[0042] In some examples, the connector 70 can include a threaded male section 70A that is configured to be fluidically connected to a mating section on a device, such as a urine collection device. In some examples, the connector 70 can also be configured to form a fluid-tight connection with the Foley catheter 10 so that when a fluid, such as urine, flows through the catheter inserter 50 (which is inserted into the lumen 34 of the Foley catheter 10), the fluid does not leak at the distal end 12A of the Foley catheter 10. For example, the connector 70 can include a threaded female section 70B that is configured to be threaded onto the connector 15 of the Foley catheter 10 to form a fluid-tight connection with the Foley catheter 10. In some examples, other techniques are used to prevent leakage at the distal end of the Foley catheter. For example, the first body distal portion 60A can include a press-fit funnel connector such that, when pushed into the distal tip 12A of the Foley catheter 10, the compliant material (on the first body distal portion 60A, on the distal tip 12A, or both) forms a fluid-tight coupling between the first body distal portion 60A and the distal tip 12A of the Foley catheter 10 (e.g., the compliant material can form a lip attached to the exterior of the connector 15, as shown). Figure 3 As another example, a compressible sealing material (e.g., formed at least in part from an expandable material such as a hydrogel, a hydrophilic polymer, etc.) can be positioned on an outer surface of connector 70 such that when catheter inserter 50 is introduced into lumen 34 of Foley catheter 10 and positioned such that connector 70 abuts distal tip 12A of Foley catheter 10, the sealing member is disposed (e.g., compressed) at the interface between connector 70 and Foley catheter 10. In some examples, the sealing member is configured to expand in the presence of a fluid to fill any gaps at the interface between the outer surface of connector 70 and distal tip 12A of Foley catheter 10 to form a fluid-tight connection between Foley catheter 10 and catheter inserter 50, or at least reduce any leakage between Foley catheter 10 and catheter inserter 50 at distal tip 12A of Foley catheter 10.

[0043] In some examples, the first body distal portion 60A is configured to interact with the hub 14 to assist the clinician in properly positioning the catheter inserter elongated body 58 within the lumen 34 of the Foley catheter. For example, the connector 70 can be positioned along the catheter inserter 50 such that the connector 70 prevents the first body distal portion 60A from entering the lumen 34 of the Foley catheter 10, for example, by having a maximum cross-sectional dimension that is greater than the cross-sectional dimension of the lumen 34. In other examples, the first body distal portion 60A can include structural features other than the connector 70 that are configured to act as a stop to limit proximal insertion of the catheter inserter 50 into the lumen 34 of the Foley catheter 10, for example, to prevent the catheter inserter elongated body 58 from obstructing the proximal fluid opening 13 of the Foley catheter 10. For example, in addition to or in lieu of the connector 70, the first body distal portion 60A can include a lip or tab or form a funnel to help prevent the catheter inserter 50 from proximally inserting too far into the lumen 34. When the second body distal portion 60B and the body proximal portion 60C are positioned in the lumen 34, the connector 70 or other structure of the contact hub 14 can provide the clinician with tactile feedback that the catheter insert 50 is properly aligned with the Foley catheter 10, for example, such that the catheter insert elongated body 58 does not cover the proximal fluid opening 13 in the lumen 34, or that a fluid-tight connection has been formed between the catheter insert 50 and the Foley catheter 10.

[0044] Second body distal portion 60B is intended to be inside the drainage lumen of Foley catheter 10, but outside the patient's body, when catheter inserter 50 is inserted into Foley catheter 10. Body proximal portion 60C is intended to be inside the drainage lumen of Foley catheter 10 and inside the patient's body when catheter inserter 50 is inserted into the drainage lumen of Foley catheter 10, such that body proximal portion 60C is within catheter proximal portion 17B.

[0045] The catheter inserter elongated body 58 is a structure extending from a distal end 64 to a proximal end 62 and defining one or more internal lumens. Figure 2-4C In the example shown, the catheter inserter elongate body 58 defines a body lumen 66 ( Figure 4B and Figure 4C). In some instances, the main body lumen 66 may be a drainage lumen configured to drain fluid from a target site, such as a bladder. In other instances, the main body lumen 66 may be used for any other suitable purpose, such as delivering a substance or another medical device to a target site in a patient's body. The main body lumen 66 may extend from the first main body fluid opening 54 to the second main body fluid opening 56. Both the first main body fluid opening 54 and the second main body fluid opening 56 may be fluidically coupled to the main body lumen 66 such that fluid may flow from one of the first main body fluid opening 54 or the second main body fluid opening 56 to the other of the first main body fluid opening 54 or the second main body fluid opening 56 through the main body lumen 66. In instances where the main body lumen 66 is a drainage lumen, the first main body fluid opening 54 and the second main body fluid opening 56 may be drainage openings.

[0046] In some examples, the catheter inserter elongated body 58 has a suitable length for entering a patient's bladder through the urethra. For example, the combined length of the second body distal portion 60B and the body proximal portion 60C of the catheter inserter elongated body 58 can be such that when the catheter inserter 50 is fully inserted into the Foley catheter 10 (e.g., the connector 70 prevents the catheter inserter elongated body 58 from being further proximally advanced into the lumen 34 of the Foley catheter 10), the body proximal end 62 is distal to the proximal fluid opening 13 of the Foley catheter 10, and in some examples, proximal to the anchoring member 18. In this way, the catheter inserter 50 does not block the flow of urine through the proximal fluid opening 13, allowing urine to flow into the Foley catheter 10 and into the catheter inserter 50 through the bodily fluid opening 54. The length can be measured along the central longitudinal axis 68 of the catheter inserter elongated body 58. In some examples, the outer diameter of the catheter inserter elongated body 58 can be between about 2 French and about 6 French, although other dimensions can be used in other examples so that the second distal body portion 60B and the proximal body portion 60C can be inserted into and / or removed from another medical device, such as a Foley catheter 10. In some examples, the catheter inserter elongated body can have an outer diameter that impedes or prevents urine from flowing between the outer surface of the catheter inserter 50 and the inner lumen 34 of the Foley catheter 10. The first distal body portion 60A, the second distal body portion 60B, and the proximal body portion 60C of the catheter inserter elongated body 58 can each have any suitable length.

[0047] A fluid collection container (e.g., a urine bag) can be attached to the second body fluid opening 56 for collecting urine drained from the patient's bladder. In some examples, the first body distal portion 60A can include a connector, such as connector 70, for connecting to other devices, such as a fluid collection container. In some examples, the first body distal portion 60A can define a funnel.

[0048] The catheter insert 50 comprises one or more sensors, such as sensor 52A, 52B or 52C (being collectively referred to as or being individually one or more sensors 52), which are configured to sense fluid or the patient's parameter of the renal condition of indication patient. Although be illustrated as on the first body distal portion 60A being positioned at the catheter insert 50, in some instances, one or more sensors 52 can be positioned at any combination of the second body distal portion 60B, main body proximal portion 60C or the first body distal portion 60A, the second body distal portion 60B and / or main body proximal portion 60C. In some instances, some parameters should be relatively close to fluid source, such as bladder sensing, because parameter can significantly change over time or based on the position of sensing parameter. Temperature can be an example that significantly changes over time, and pressure is an example parameter that can change based on the position of sensing parameter. Temperature and pressure are two parameters that can be better sensed at the catheter proximal portion 17B place (relatively close to fluid source) of Foley catheter 10. Thus, in some examples, one or more sensors 52 may be located in the proximal body portion 60C of the catheter inserter 50, such as a temperature sensor and / or a pressure sensor.

[0049] The one or more sensors 52 are configured to transmit sensor data to the external device 24 ( Figure 3 In some examples where one or more of the sensors 52 are located on the second body distal portion 60B or the body proximal portion 60C, the one or more sensors can transmit sensor data to the external device 24 via an embedded wire or fiber optic cable through a connection within the catheter inserter elongated body 58 of the catheter inserter 50. In other examples, the wire or fiber optic cable can run between the outer surface of the catheter inserter 50 and the lumen 34, within another inner lumen of the catheter, or outside the Foley catheter 10. In other examples, the one or more sensors 52 can transmit sensor data to the external device 24 via wireless communication techniques.

[0050] In some instances, one or more sensors located on the first body distal portion 60A (e.g., sensor 52A) or the second body distal portion 60B (e.g., sensor 52B) may be relatively large, require relatively more electrical or optical connections and / or sense parameters that may be relatively far from the fluid source compared to the parameters sensed by the sensors located on the body proximal portion 60C. Thus, the parameters that the one or more or one or more sensors 52 located on the first body distal portion 60A or the second body distal portion 60B are configured to sense may include parameters that do not substantially vary significantly over time or based on the location of the sensed parameters. Because the catheter inserts of the present disclosure include a material that is substantially impermeable to the substance of interest, the sensors located on the first body distal portion 60A or the second body distal portion 60B may also be configured to sense parameters that otherwise vary significantly over time or based on the location of the sensed parameters, such as the amount of dissolved oxygen in urine (oxygen tension or uPO2) or the amount of dissolved carbon dioxide in urine. In some examples, the one or more sensors 52 may include sensors configured to sense urine volume (e.g., flow rate or volume), urine concentration, the amount of dissolved oxygen in urine, the amount of dissolved carbon dioxide in urine, urine pH, urine color, urine creatinine, urine conductivity, urine specific gravity, urine biomarkers, and / or motion. For example, the one or more sensors 52 may include a color sensor, a creatinine sensor, a flow sensor, a pH sensor, a volume sensor, a dissolved gas sensor (e.g., a dissolved oxygen sensor or a dissolved carbon dioxide sensor), a urine conductivity sensor, a urine specific gravity sensor, a urine biomarker sensor, or a motion sensor.

[0051] In some examples, one or more sensors 52 are mechanically attached to the catheter inserter elongated body 58 or another portion of the catheter inserter 50 by being embedded in the catheter inserter elongated body 58, via a crimped tape or another suitable attachment mechanism or combination of attachment mechanisms, using any suitable technique, such as, but not limited to, adhesives, welding. In some examples, the one or more sensors 52 are not mechanically attached to the catheter inserter elongated body 58 or the catheter inserter 50, but are mechanically attached to a structure distal to the distal end 64 of the body of the catheter inserter 50, such as a tube extending between the hub 14 and a fluid collection container.

[0052] Figure 3 FIG. 5 is a diagram illustrating a catheter inserter 50 inserted into a Foley catheter 10. Figure 3 In the example shown in FIG. 5 , the catheter inserter 50 is shown in dashed lines. For example, the proximal portion 60C of the body of the catheter inserter 50 can be inserted through the distal fluid opening 14A of the Foley catheter 10, such as the second drainage opening ( Figure 1 ) and enters lumen 34 (shown in Figure 4A), such that the proximal body portion 60C of the catheter inserter 50 is received within the proximal catheter portion 17B of the Foley catheter 10, and the second distal body portion 60B of the catheter inserter 50 is received within the distal catheter portion 17A of the Foley catheter 10. In this example, the first distal body portion 60A of the catheter inserter 50 remains outside the Foley catheter 10. In some examples, when the connector 70 is coupled to the distal end 12A of the Foley catheter 10 or the lip 53 (as in Figure 3 14 in the illustrated example) such that the catheter inserter elongated body 58 cannot be further introduced into the lumen 34 without removing the connector 70 or otherwise disrupting the integrity of the connector 70, the body proximal end 62 of the catheter inserter 50 is distal to the proximal fluid opening 13, e.g., the first drainage opening, allowing fluid, such as urine, to flow into the Foley catheter 10 via the proximal fluid opening 13, through the first body fluid opening 54 of the catheter inserter 50, and through the body lumen 66 of the catheter inserter 50 to the fluid opening 56 of the catheter inserter 50. A fluid collection container, e.g., a urine bag, may be fluidly coupled to the fluid opening 56 ( Figure 2 ).

[0053] In some examples, when catheter inserter 50 is inserted into Foley catheter 10, one or more sensors 52 may be external to Foley catheter 10. In other examples, when catheter inserter 50 is inserted into Foley catheter 10, one or more of the one or more sensors 52 may be internal to Foley catheter 10. One or more sensors 52 may be coupled to external device 24.

[0054] One or more sensors 52 can be configured to transmit sensor data to an external device 24. External device 24 can be a computing device, such as a workstation, desktop computer, laptop computer, smartphone, tablet computer, server, or any other type of computing device that can be configured to receive, process, and / or display sensor data. One or more sensors 52 can transmit the sensor data to the external device via connection 26. Connection 26 can be an electrical, optical, wireless, or other connection.

[0055] Although Figure 3In the embodiment of the present invention, only one sensor 52 is shown, but in other examples, the catheter inserter 50 may include any appropriate number of sensors on the main body proximal portion 60C, any appropriate number of sensors on the second body distal portion 60B and any appropriate number of sensors on the first body distal portion 60A, wherein the sensor sensing same or different parameters on the main body proximal portion 60C, the sensor sensing same or different parameters on the second body distal portion 60B, and the sensor sensing same or different parameters on the first body distal portion 60A. In addition, some or all of the sensors on the main body proximal portion 60C can sense the same or different parameters with the sensor on the second body distal portion 60B or the first body distal portion 60A. For example, the sensor on the distal portion can be temperature-dependent, and may need to sense temperature on main body proximal portion 60C, second body distal portion 60B and / or first body distal portion 60A.

[0056] The catheter inserter elongate body 58 can be structurally configured to be relatively flexible, pushable, and relatively resistant to kinking and bending, such that it can resist bending when a pushing force is applied to a relatively distal portion of the catheter inserter 50 to advance the elongate body proximally through the distal fluid opening 14A of the Foley catheter 10. Kinking and / or bending of the catheter inserter elongate body 58 can hinder a clinician's efforts to advance the elongate body proximally.

[0057] Because some substances of interest can dissipate from or penetrate into a fluid, such as urine, within the lumen 34 of the elongated catheter body 12 of the Foley catheter 10, the elongated catheter body 58 of the catheter insert 50 can be made of or include a material that is substantially impermeable (e.g., impermeable or nearly impermeable) to one or more substances of interest. In some instances, the elongated catheter body 58 can be made entirely or primarily of a material that is substantially impermeable to the substances of interest. In other instances, the elongated catheter body 58 can be configured so that the material is positioned to minimize or even prevent the substances of interest from exiting the body lumen 66 via the sidewalls of the elongated catheter body 58, wherein the sidewalls can be walls extending between the body distal end 64 and the body proximal end 62. In addition to or in lieu of minimizing or preventing the substances of interest from exiting the body lumen 66 via the sidewalls, in some instances, the material can be configured and positioned to minimize or even prevent, in some instances, the substances of interest or other contaminants from entering the body lumen 66 via the sidewalls.

[0058] Like Guan Figure 4A and 4BAs discussed in further detail, in some instances, a material that is substantially impermeable to a substance of interest can be positioned along an inner surface of the catheter inserter elongated body 58 defining the body lumen 66. In addition to or in lieu of being positioned on the inner surface, the material can be positioned along an outer surface of the catheter inserter elongated body 58. In this manner, a material that is substantially impermeable to a substance of interest can help minimize or even eliminate degradation and / or contamination of the substance of interest as the fluid in which the substance of interest is present propagates through the body lumen 66 of the catheter inserter elongated body 58 to one or more sensors 52 that can be located on or distal to the first body distal portion 60A. In this manner, the catheter inserter 50 is configured such that the one or more sensors 52 can sense a substance of interest even when the one or more sensors 52 are positioned relatively far from the body proximal end 62 of the catheter inserter elongated body 58 and a source of fluid, such as the bladder.

[0059] The material that is substantially impermeable to the substance of interest can extend from any suitable location on the proximal body portion 60C of the catheter insertion elongated body 58 to any suitable location on the second body distal portion 60B or the first body distal portion 60A of the catheter insertion elongated body 58 to inhibit degradation and / or contamination of the substance of interest. For example, the material can extend from the proximal body end 62 to the distal body end 64. In other examples, the material can extend from the proximal body end 62 to the one or more sensors 52.

[0060] In some instances, the catheter inserter elongated body 58 is formed by two or more discrete and separate longitudinal extension sections that are for example mechanically connected to each other at the axial butt joint place. In other instances, the catheter inserter elongated body 58 can be substantially continuous along the length of the catheter inserter elongated body 58, rather than being formed by two or more discrete and separate longitudinal extension sections that are for example mechanically connected to each other at the axial butt joint place. Compared with the elongated body that comprises two or more longitudinal extension segments that are mechanically connected to each other, substantially continuous catheter inserts the elongated body 58 and can better be configured to distribute power in longitudinal direction (on the direction of central longitudinal axis 68) and direction of rotation (rotation around central longitudinal axis 68). Therefore, the substantially continuous structure of the catheter inserter elongated body 58 can help the catheter inserter elongated body 58 that axial urging force is transferred to the main body proximal portion 60C from the first body distal portion 60A of the catheter inserter elongated body 58, and the rotational force (if existing) that will be applied to the first body distal portion 60A of the catheter inserter elongated body 58 is transferred to the ability of the main body proximal portion 60C.

[0061] In some examples, at least a portion of the outer surface of the catheter inserter elongate body 58 includes one or more coatings, such as a lubricious coating. The lubricious coating can be configured to reduce static and / or dynamic friction between the catheter inserter elongate body 58 and the lumen 34 of the Foley catheter 10 as the catheter inserter elongate body 58 is advanced.

[0062] Figures 4A-4C A diagram illustrating an example cross section of a catheter inserter 50 and a Foley catheter 10, wherein the cross section is taken along Figure 3 Line 2 - 2 in FIG. 1 is taken in a direction normal to the central longitudinal axis 16 . Figure 4A A cross-section of the elongated catheter body 12 of the Foley catheter 10 is depicted, defining a lumen 34 and a lumen 36. In some examples, the lumen 34 may be referred to as a drainage lumen and configured to drain urine from the patient's bladder, and the lumen 36 may be configured to deliver an inflation fluid to the anchoring member 18 (at Figure 1 In operation, lumen 34 can serve as a passage for urine to enter Foley catheter 10 through proximal fluid opening 13 to distal fluid opening 14A.

[0063] Figure 4B 1 is a diagram illustrating a cross section of a Foley catheter 10 and an example catheter inserter 50 when the catheter inserter 50 is inserted into the Foley catheter 10. Figure 4B In some embodiments, the catheter insert 50 can be constructed of a material that is substantially impermeable to substances of interest, such as oxygen and / or carbon dioxide. In some embodiments, the material can be at least one of nylon, PET, or PTFE.

[0064] As depicted, the outer periphery of the catheter inserter elongated body 58 contacts the inner surface 38 defining the lumen 34 of the Foley catheter 10. In other examples, the outer periphery of the catheter inserter elongated body 58 may not contact or may partially contact the inner surface 38 defining the lumen 34. In some examples, the outer periphery of the catheter inserter elongated body 58 contacts or partially contacts the inner surface 38 defining the lumen 34 along the entire length of the second body distal portion 60B and the body proximal portion 60C. In other examples, the outer periphery of the catheter inserter elongated body 58 does not contact or partially contacts the inner surface 38 defining the lumen 34 along the entire length of the second body distal portion 60B and the body proximal portion 60C. The body lumen 66 of the catheter inserter 50 can serve as a passage for urine to enter the catheter inserter 50 through the first body fluid opening 54 to the second body fluid opening 56. Although the body lumen 66 is depicted as circular in cross-section, it can be of any shape in other examples.

[0065] Figure 4C 1 and 2 are diagrams illustrating cross sections of the Foley catheter 10 and another example catheter inserter when the catheter inserter is inserted into the Foley catheter 10. Figure 4C The catheter inserter may be an example of the catheter inserter 50. Figure 4C In the illustrated example, the catheter insert includes a catheter insert elongated body 76 made of a plurality of material layers, such as a first material layer 74 and a second material layer 72, which may be concentrically arranged in examples in which the catheter insert elongated body 76 has an annular cross-section or similarly stacked in a radially outward direction in examples in which the catheter insert elongated body 76 defines a non-circular cross-section (e.g., elliptical, rectangular, square, etc.). In some examples, the first material layer 74 is relatively impermeable to substances of interest, such as oxygen and / or carbon dioxide, and is positioned along the inner surface of the catheter insert elongated body 76 that defines the body lumen 66. In some examples, the second material layer is relatively permeable to substances of interest, such as oxygen and / or carbon dioxide. In some examples, the first material layer 74 extends along the entire length of the body lumen 66, while in other examples, the first material layer 74 extends only along a portion of the length of the body lumen 66, such as from a proximal portion of the body to one or more sensors, which may help maintain a desired level of flexibility of the catheter insert elongated body 76. In addition, as Figure 4C As shown, in some examples, the first material layer 74 extends around the entire inner periphery of the body lumen 66 (eg, the inner circumference in examples where the inner periphery is circular in cross-section).

[0066] First material layer 74 can be selected based on the desire to restrict flow of one or more substances of interest from or into catheter inserter elongate body 76. In some examples, layer 74 of first material can be one or more of nylon, PET, or PTFE.

[0067] In some examples, the first material layer 74 is relatively thin, wherein the thickness of the first material layer 74 is measured in a direction orthogonal to the central longitudinal axis 16, such as in a radial direction. For example, the first material layer 74 can be in the range of 0.001 to 0.100 inches (0.0254 mm to 2.54 mm) thick. In other examples, the first material layer 74 can be in the range of 0.0005 to 0.050 inches (0.0127 mm to 1.27 mm) thick. By keeping the first material layer 74 relatively thin, the catheter insert can remain relatively flexible.

[0068] In other examples, the first material layer 74 may be relatively permeable to the substance of interest, but the second material layer 72 may be relatively impermeable to the substance of interest. For example, the second material layer 72 may be the outermost surface of the catheter insert elongated body 76, or may be covered by another material, such as a lubricious coating. In other examples, the second material layer 72 may be an intermediate layer of the wall of the catheter insert elongated body 76, such as positioned between structural layers of silicone rubber or another suitable flexible material.

[0069] The first material layer 74 and / or the second material layer 72 can be relatively impermeable to substances of interest, such as oxygen and / or carbon dioxide. In some instances, the first material layer 74 and / or the second material layer 72 can be nylon, PET or PTFE. In some instances, the first material layer 74 and / or the second material layer 72 are relatively thin. For example, the first material layer 74 and / or the second material layer 72 of material 32 can be within the range of 0.001 to 0.100 inches (0.0254 mm to 2.54 mm). By keeping the first material layer 74 and / or the second material layer 72 relatively thin, the catheter inserter elongated body 76 can remain flexible. In some instances, the first material layer 74 and / or the second material layer 72 of material 32 extend from the body distal end to the body proximal end along the entire length of the catheter inserter elongated body 76, and in other instances, the first material layer 74 and / or the second material layer 72 only extend along a portion of the length of the catheter inserter elongated body 76.

[0070] Additionally, in some instances, the first material layer 74 and / or the second material layer 72 extend around the entire periphery of the catheter insert elongated body 58, while in other instances, the first material layer 74 and / or the second material layer 72 extend around less than the entire periphery of the catheter insert elongated body 76, such as approximately 90% or more of the entire periphery of the catheter insert elongated body 76, which can help maintain a desired level of flexibility of the catheter insert elongated body 76.

[0071] Figure 5 A flowchart illustrating an example method of using a Foley catheter 10 and a catheter inserter 50 is provided. A clinician can insert the Foley catheter 10 into the patient's bladder and then secure the Foley catheter to the patient via an anchoring member on a proximal portion of the elongated body of the Foley catheter (80). For example, the clinician can secure the Foley catheter 10 to the patient via the anchoring member 18. For example, the clinician can connect the inflation opening 14B to an inflation device and inflate the anchoring member 18 using, for example, the inflation device and an inflation fluid, such as sterile water, saline, or gas. In examples where the anchoring member 18 is an expandable structure, the clinician can deploy the anchoring member 18 by pushing the structure radially outward or pulling the structure back to cause the expandable structure to expand radially outward.

[0072] The clinician can connect the fluid opening on the first distal end of the catheter inserter 50 to a fluid collection container. For example, the clinician can connect the second bodily fluid opening 56 of the catheter inserter 50 to a fluid collection container, such as a urine bag. The clinician can introduce the proximal end of the catheter inserter 50 into the drainage lumen of a Foley catheter, the catheter inserter including an elongated catheter inserter body defining a body lumen (84). For example, the clinician can insert the body proximal end 62 of the catheter inserter 50 into the lumen 34 of the Foley catheter 10. The clinician can insert the body proximal end 62 of the catheter inserter 50 into the lumen 34 before inserting the Foley catheter 10 into the patient's bladder or after the Foley catheter 10 is positioned in the patient.

[0073] The clinician can advance the proximal body tip 62 of the catheter inserter 50 to a target site in the lumen 34 (86). For example, the clinician can advance the proximal body tip 62 of the catheter inserter 50 through the patient to a target site, such as proximal to the anchoring member 18 and distal to the proximal fluid opening 13 of the Foley catheter 10.

[0074] One or more sensors positioned on the elongated body of the catheter insert can sense one or more parameters, at least one of which includes a substance of interest in the fluid in the main lumen (88). For example, one or more sensors 52 can sense one or more parameters of urine transported through the main lumen 66. For example, one or more sensors 52 can physically contact the urine flowing through the main lumen 66 and can sense one or more parameters such as temperature, pressure, urine volume (e.g., flow rate or volume), urine concentration, amount of dissolved oxygen in urine, amount of dissolved carbon dioxide in urine, urine pH, urine color, urine creatinine, and / or motion. In some instances, the substance of interest can be at least one of oxygen or carbon dioxide. In some instances, one or more sensors 52 can sense urine between the catheter insert 50 and the fluid collection container.

[0075] Although Figure 5 The example of FIG1 illustrates a number of steps, but these steps can be performed in a different order or simultaneously. For example, the clinician can connect the fluid opening 56 of the catheter inserter 50 to a fluid collection container after introducing the proximal end 62 of the body of the catheter inserter 50 into the lumen 34 of the Foley catheter 10.

[0076] Figure 6 1 is a functional block diagram illustrating an example of an external device 24 configured to communicate with and receive information from one or more sensors 52 of a catheter inserter 50. Figure 6In the example of FIG, external device 24 includes processing circuitry 200, memory 202, user interface (UI) 204, and communication circuitry 206. External device 24 may be a dedicated hardware device with dedicated software for reading sensor data. Alternatively, external device 24 may be an off-the-shelf computing device, such as a desktop computer, laptop computer, tablet computer, or smartphone running a mobile application that enables external device 24 to read sensor data from one or more sensors 52.

[0077] In some examples, the user of the external device 24 may be a clinician, physician, or healthcare provider. In some examples, the user uses the external device 24 to monitor the patient's renal function. In some examples, the user may interact with the external device 24 via a UI 204, which may include a display that presents a graphical user interface to the user and a keyboard or another mechanism (such as a touch-sensitive screen) for receiving input from the user. The external device 24 may communicate with one or more sensors 52 using wired, wireless, or optical methods via a communication circuit system 206.

[0078] Processing circuitry 200 and other processing circuitry described herein may include any combination of integrated circuitry, discrete logic circuitry, analog circuitry (e.g., one or more microprocessors), digital signal processors (DSPs), application specific integrated circuits (ASICs), or field programmable gate arrays (FPGAs). In some examples, processing circuitry 200 may include multiple components, such as one or more microprocessors, one or more DSPs, one or more ASICs, or one or more FPGAs, as well as any combination of other discrete or integrated logic circuitry, and / or analog circuitry.

[0079] Memory 202 may store program instructions, such as software 208, which may include one or more program modules executable by processing circuitry 200. When executed by processing circuitry 200, such program instructions may enable processing circuitry 200 and external device 24 to provide the functionality attributed thereto. The program instructions may be embodied in software and / or firmware. Memory 202 may include any volatile, nonvolatile, magnetic, optical, or electrical medium, such as random access memory (RAM), read-only memory (ROM), nonvolatile RAM (NVRAM), electrically erasable programmable ROM (EEPROM), flash memory, or any other digital medium.

[0080] This disclosure includes the following examples.

[0081] Example 1. A device comprising: an elongated body defining a body lumen, the elongated body being configured to be at least partially inserted proximally into a catheter lumen defined by a catheter without covering a proximal fluid opening of the catheter and forming a fluid-tight connection with the catheter; and one or more sensors positioned on the elongated body, at least one of the one or more sensors being configured to sense a substance of interest in the fluid within the body lumen, wherein the elongated body comprises a material that is substantially impermeable to the substance of interest.

[0082] Example 2. The device of Example 1, wherein the one or more sensors comprise at least one of a temperature sensor, a pressure sensor, a dissolved gas sensor, a flow sensor, a volume sensor, a pH sensor, a creatinine sensor, a color sensor, a urine conductivity sensor, a urine specific gravity sensor, a urine biomarker sensor, or a motion sensor.

[0083] Example 3. The device of example 1 or 2, wherein the one or more sensors comprise a dissolved gas sensor comprising at least one of a dissolved oxygen sensor or a dissolved carbon dioxide sensor.

[0084] Example 4. The device of any combination of examples 1 to 3, wherein the material is configured to minimize flow of a substance of interest from the body lumen to an environment external to the elongated body.

[0085] Example 5. The device of any combination of examples 1 to 4, wherein the material comprises at least one of nylon, polyethylene terephthalate (PET), or polytetrafluoroethylene (PTFE).

[0086] Example 6. The device of any combination of examples 1 to 5, wherein the substance of interest comprises at least one of oxygen or carbon dioxide.

[0087] Example 7. The device of any combination of examples 1 to 6, wherein the material is a first material and the elongated body comprises a layer of the first material and a layer of a second material permeable to the substance of interest.

[0088] Example 8. The device of Example 7, wherein the first material is disposed on an inner surface of the elongated body, the inner surface defining the body lumen.

[0089] Example 9. The device of example 7 or 8, wherein the first material is disposed on an outer surface of the elongated body.

[0090] Example 10. A device according to any one of Examples 1 to 9, wherein at least one of the one or more sensors is positioned on a distal portion of the slender body, the distal portion having a cross-sectional dimension larger than the catheter lumen so that the distal portion can remain outside the catheter lumen when the slender body is inserted into the catheter lumen.

[0091] Example 11. The device of Example 10, wherein the distal portion defines a funnel.

[0092] Example 12. The device of Example 10 or 11, wherein the distal portion is configured to connect to a fluid collection container.

[0093] Example 13. A device according to any combination of Examples 1 to 12, wherein the material extends from a first distal portion of the slender body to a proximal portion of the slender body, and wherein the body lumen is configured to transport urine from the proximal portion to the distal portion.

[0094] Example 14. An assembly comprising: a Foley catheter comprising an elongated catheter body defining a drainage lumen, the elongated catheter body comprising a catheter distal portion and a catheter proximal portion, the catheter proximal portion defining a first drainage opening for fluid coupling to the drainage lumen, and the catheter distal portion defining a second drainage opening for fluid coupling to the drainage lumen; and a catheter inserter comprising: an elongated catheter inserter body defining a body lumen, the elongated catheter inserter body comprising a first body distal portion, a second body distal portion, and a body proximal portion, the body proximal portion defining a first body fluid opening for fluid coupling to the body lumen, and the first body distal portion defining a second body fluid opening for fluid coupling to the body lumen. The catheter inserter elongated body comprises a second body fluid opening coupled to the body lumen, wherein the catheter inserter elongated body is configured such that when the first body distal portion is connected to the Foley catheter while the second body distal portion and the body proximal portion are inserted into the drainage lumen, the proximal end of the catheter inserter elongated body remains distal to the first drainage opening of the Foley catheter; and one or more sensors positioned on the catheter inserter elongated body, at least one of the one or more sensors being configured to sense a substance of interest, wherein the catheter inserter elongated body comprises a material that is substantially impermeable to the substance of interest, the material extending from the first body fluid opening to the at least one of the one or more sensors.

[0095] Example 15. The assembly of Example 14, wherein at least one of the one or more sensors is positioned on the first distal portion of the catheter inserter elongated body.

[0096] Example 16. The assembly of example 15, wherein the at least one sensor comprises a dissolved gas sensor comprising at least one of a dissolved oxygen sensor or a dissolved carbon dioxide sensor.

[0097] Example 17. An assembly according to any combination of Examples 14-16, wherein the one or more sensors include at least one of a temperature sensor, a pressure sensor, a dissolved gas sensor, a flow sensor, a volume sensor, a pH sensor, a creatinine sensor, a color sensor, a urine conductivity sensor, a urine specific gravity sensor, a urine biomarker sensor, or a motion sensor.

[0098] Example 18. The assembly of any combination of examples 14 to 17, wherein the material comprises at least one of nylon, polyethylene terephthalate (PET), or polytetrafluoroethylene (PTFE), and the catheter insert is stiffer than a Foley catheter.

[0099] Example 19. The assembly of any combination of examples 14 to 18, wherein the catheter inserter is configured to form a fluid-tight coupling with a Foley catheter.

[0100] Example 20. A method comprising: introducing a proximal end of a catheter insert into a lumen of a catheter, the catheter insert comprising: an elongated body defining a body lumen; and one or more sensors positioned on the elongated body, at least one of the one or more sensors being configured to sense a substance of interest in a fluid within the body lumen, wherein the elongated body comprises a material that is substantially impermeable to the substance of interest; advancing the catheter insert proximally into the drainage lumen so that the proximal end of the catheter insert is proximal to an anchoring member of the catheter and distal to a proximal fluid opening of the catheter; and fluidly coupling the catheter insert and the catheter.

[0101] Example 21. The method of Example 20, wherein the one or more sensors include at least one of a temperature, pressure, dissolved gas sensor, flow sensor, volume sensor, pH sensor, creatinine sensor, color sensor, urine conductivity sensor, urine specific gravity sensor, urine biomarker sensor, or motion sensor.

[0102] Example 22. The method of Example 20 or 21, wherein the one or more sensors comprise a dissolved gas sensor comprising at least one of a dissolved oxygen sensor or a dissolved carbon dioxide sensor.

[0103] Example 23. The method of any combination of Examples 20 to 22, wherein the material is configured to minimize flow of a substance of interest from the body lumen to an environment external to the elongated body of the catheter inserter.

[0104] Example 24. The method of any combination of examples 20 to 23, wherein the material comprises at least one of nylon, polyethylene terephthalate (PET), or polytetrafluoroethylene (PTFE).

[0105] Example 25. The method of any combination of examples 20 to 24, wherein the substance of interest comprises at least one of oxygen or carbon dioxide.

[0106] Example 26. The method of any combination of examples 20 to 25, wherein the material is a first material and the catheter inserter elongate body comprises a layer of the first material and a layer of a second material permeable to the substance of interest.

[0107] Example 27. The method of Example 26, wherein the first material is disposed on an inner surface of the elongated body of the catheter inserter, the inner surface defining the body lumen.

[0108] Example 28. The method of example 26 or 27, wherein the first material is disposed on an outer surface of the elongated body of the catheter insert.

[0109] Example 29. The method of any combination of Examples 20 to 28, further comprising connecting a fluid opening on the distal tip of the catheter inserter to a fluid collection container.

[0110] Various examples have been described. These and other examples are within the scope of the following claims.

Claims

1. A catheter insert comprising: A catheter inserter elongated body defining a body lumen, the catheter inserter elongated body comprising: a first body distal portion; a second body distal portion configured to be inserted into a drainage lumen of a catheter; and a proximal body portion configured to be inserted into the drainage lumen such that a proximal end of the catheter inserter elongated body remains distal to a drainage opening of the catheter while the second distal body portion and the proximal body portion are within the drainage lumen, wherein the proximal body portion defines a first body fluid opening fluidly coupled to the body lumen and the first distal body portion defines a second body fluid opening fluidly coupled to the body lumen; as well as one or more sensors positioned on the elongated body of the catheter inserter, at least one of the one or more sensors being configured to sense a substance of interest, wherein the catheter inserter elongate body comprises a material that is substantially impermeable to the substance of interest, the material extending from the first body fluid opening to at least one of the one or more sensors.

2. The catheter insert of claim 1 , wherein the one or more sensors comprise at least one of a temperature sensor, a pressure sensor, a dissolved gas sensor, a flow sensor, a volume sensor, a pH sensor, a creatinine sensor, a color sensor, a urine conductivity sensor, a urine specific gravity sensor, a urine biomarker sensor, or a motion sensor.

3. The catheter insert of claim 1, wherein the one or more sensors comprise a dissolved gas sensor comprising at least one of a dissolved oxygen sensor or a dissolved carbon dioxide sensor.

4. The catheter insert of any one of claims 1 to 3, wherein the material is configured to minimize flow of a substance of interest from the lumen to an environment external to the elongate body.

5. The catheter inserter according to any one of claims 1 to 3, wherein the material comprises at least one of nylon, polyethylene terephthalate (PET), or polytetrafluoroethylene (PTFE), and the catheter inserter is stiffer than the catheter.

6. The catheter insert of any one of claims 1 to 3, wherein the substance of interest comprises at least one of oxygen or carbon dioxide.

7. The catheter inserter according to any one of claims 1 to 3, wherein the material is a first material and the catheter inserter elongate body comprises a layer of the first material and a layer of a second material permeable to the substance of interest.

8. The catheter inserter of claim 7, wherein the first material is disposed on an interior surface of the catheter inserter elongated body, the interior surface defining the body lumen.

9. The catheter inserter of claim 7, wherein the first material is disposed on an outer surface of the catheter inserter elongated body.

10. The catheter inserter according to any one of claims 1 to 3, wherein the at least one sensor of the one or more sensors is positioned on the first body distal portion of the catheter inserter elongated body. The catheter inserter of claim 10 , wherein the first body distal portion defines a funnel.

12. The catheter inserter of claim 10, wherein the first body distal portion is configured to connect to a fluid collection container.

13. The catheter insert of any one of claims 1 to 3, wherein the material extends from the first body distal portion to the body proximal portion, and wherein the body lumen is configured to transport urine from the proximal portion to the first body distal portion.

14. The catheter inserter according to any one of claims 1 to 3, wherein the body proximal portion is configured to be removable from the drainage lumen.

15. An assembly comprising: a Foley catheter comprising an elongated catheter body defining a drainage lumen, the elongated catheter body comprising a distal catheter portion and a proximal catheter portion, the proximal catheter portion defining a first drainage opening fluidly coupled to the drainage lumen, and the distal catheter portion defining a second drainage opening fluidly coupled to the drainage lumen; and A catheter inserter comprising: a catheter inserter elongated body defining a body lumen, the catheter inserter elongated body comprising a first body distal portion, a second body distal portion, and a body proximal portion, the body proximal portion defining a first body fluid opening fluidly coupled to the body lumen, and the first body distal portion defining a second body fluid opening fluidly coupled to the body lumen, wherein the catheter inserter elongated body is configured such that when the first body distal portion is connected to the Foley catheter while the second body distal portion and the body proximal portion are inserted into the drainage lumen, a proximal tip of the catheter inserter elongated body remains distal to the first drainage opening of the Foley catheter; and one or more sensors positioned on the elongated body of the catheter inserter, at least one of the one or more sensors being configured to sense a substance of interest, wherein the catheter insert elongate body comprises a material that is substantially impermeable to a substance of interest, the material extending from the first body fluid opening to the at least one of the one or more sensors.

16. The assembly of claim 15, wherein the material comprises at least one of nylon, polyethylene terephthalate (PET), or polytetrafluoroethylene (PTFE), and the catheter insert is stiffer than the Foley catheter.

17. An assembly according to claim 15 or claim 16, wherein the catheter inserter is configured to form a fluid tight coupling with the Foley catheter.

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