Peripherally Inserted Central Catheters (PICCs) and Methods for Their Use

Abstract

A peripherally insertable central catheter (PICC) configured for insertion into a blood vessel is provided, the catheter including a distal portion including a distal end opening, a proximal portion including a proximal opening, at least one flushing lumen extending therebetween, and a valve disposed within the at least one flushing lumen and having two configurations: an open configuration that allows fluid flow through the distal end opening, and a closed configuration that blocks fluid flow through the distal end opening, wherein in the closed configuration of the valve, flushing fluid admitted to the catheter through the proximal opening circulates back and flows out of a subject's blood vessel through the proximal portion, thereby preventing the flushing fluid from exiting through the distal end opening.

Description

[Technical field]

[0001] FIELD OF THE DISCLOSURE The present disclosure relates generally to peripherally inserted central catheters (PICCs) and methods of use thereof. [Background technology]

[0002] Catheters are long-established medical devices based on hollow lumens that are typically introduced into organs or blood vessels in the body to drain fluids, deliver medical substances, provide nutrition, monitor, and perform other medical-related procedures. Peripherally inserted central catheters (PICCs) are a type of catheter typically performed for chronic medical intravenous (IV) therapy, such as cancer treatment. Typically, PICCs are inserted through a peripheral arm vein using a nitinol guidewire and x-ray imaging. Once inserted, PICC devices may remain in the patient's body for extended periods of time (in some cases, more than six months). Such extended periods of use increase the risk of PICCs causing infections. These risks include, for example, the presence of external bacteria, internal bacteria, or contaminants that become established in the body during the wearing of the device and / or due to the presence of gaps between the PICC and the body. Catheter-associated bloodstream infections, bacterial growth, as well as blood clotting, obstruction, sediment deposition, air embolism, disposition, leakage, the presence of kinks, and other malfunctions of catheters are highly associated with deterioration of the patient's condition and may even lead to death.

[0003] Flushing of PICC devices with irrigation solutions such as saline is a commonly applied method that is routinely performed even after medical treatment to remove unwanted material and bacteria from the catheter lumen and maintain catheter patency. Proper flushing procedures are very important to prevent the accumulation of unwanted material in the catheter lumen.

[0004] Nonetheless, there exists a need in the art for improved PICC designs and flushing methods to facilitate disinfection and removal of undesirable material from the catheter lumen. Summary of the Invention [Problem to be solved by the invention]

[0005] Aspects of the present disclosure, according to some embodiments thereof, relate to catheters, particularly but not limited to peripherally insertable central catheters (PICCs) for administering fluids, such as medical substances and nutrients, to a subject. Following delivery of medical substances to blood vessels and / or body organs, the PICC is periodically flushed by introducing a flushing fluid, such as saline, into the catheter. Although the flushing fluid minimizes the accumulation of bacteria, clotting factors, and the like, inside the catheter, typically the flushing fluid is expelled into the subject's body, resulting in the administration of undesirable substances to the subject. However, a particular design of the present disclosure encompasses a PICC that includes at least one flushing lumen and a valve disposed within the at least one flushing lumen. The valve is configured in two configurations: an open configuration that allows fluid flow through a distal end face opening, and a closed configuration that blocks fluid flow through the distal end face opening. In the closed configuration of the valve, flushing fluid introduced into the catheter through the proximal opening circulates back through the proximal portion and exits the subject's blood vessel, thereby preventing flushing fluid from being discharged through the distal end opening. The disclosed device allows for the discharge of circulated flushing fluid outside of the blood vessel and / or body organ. Thus, the disclosure allows for further analysis of said flushing fluid to identify contaminants, bacteria, and other undesirable materials. Furthermore, the valve allows for controllable and rapid transitions between the open and closed configurations, providing a closed circulation system for flushing fluid to circulate in both directions, thus significantly reducing the risk of infection and accumulation of sediments inside the catheter. Closing the PICC may also help prevent bacterial colonization caused by back pressure and movement of the PICC inside the body when not in operation. [Means for solving the problem]

[0006] Certain embodiments of the present disclosure may include some, all, or any of the advantages described above. One or more other technical advantages will be readily apparent to those skilled in the art from the drawings, descriptions, and claims contained herein. Moreover, although certain advantages have been enumerated above, various embodiments may include all, some, or none of the enumerated advantages.

[0007] According to some embodiments, the at least one flushing lumen may be divided into a plurality of individual lumens. According to some embodiments, the at least one flushing lumen may be divided into two individual lumens, a first lumen configured to deliver flushing fluid and a second lumen configured to collect and direct flushing fluid to a proximal portion and drain the fluid from the subject's blood vessel, thereby preventing the flushing lumen containing contaminants, precipitates, clotting factors, bacteria, etc. from being delivered to the subject's body. According to some embodiments, the at least one flushing lumen may be divided into three individual lumens, with a third lumen configured to deliver a medical substance to the subject.

[0008] According to some embodiments, the valve may include an inflatable element configured to expand to a size sufficient to seal the distal end opening. According to some embodiments, the inflatable element may be a balloon. According to some embodiments, the catheter may include an inflation conduit in fluid flow communication with the inflatable element. According to some embodiments, inflation and deflation of the inflatable element may be performed via the inflation conduit.

[0009] According to some embodiments, the valve may include a sealing flap and / or shutter configured to controllably seal the distal end opening.

[0010] According to some embodiments, the catheter may include one or more sensors for monitoring and / or regulating the pressure and / or volume of fluid (e.g., flushing fluid, medical substance) entering and / or exiting the catheter.

[0011] Also disclosed herein is a method of flushing a PICC, the method including the steps of providing a PICC as described above and inserting a distal portion of the PICC into a blood vessel and / or body organ of a subject, the method also including the steps of shifting a valve to a closed configuration to block fluid flow through the distal end opening, and injecting a flushing fluid into the catheter through its proximal opening, thereby preventing the flushing fluid from being discharged through the distal end opening into the blood vessel of the subject as the flushing fluid circulates back through the proximal portion and is discharged from the catheter.

[0012] According to some embodiments, the method further comprises analyzing the flushing fluid for chemical and / or biological substances indicative of complications and / or infection. According to some embodiments, analysis of the flushing fluid may include identification of blood clots and / or bacteria.

[0013] According to some embodiments, the method may include analyzing one or more parameters related to the pressure at which the flushing fluid exits and / or enters the catheter to evaluate performance qualities of the catheter and / or the flushing fluid.

[0014] According to some embodiments, the method may include monitoring and / or regulating the pressure of the flushing liquid using one or more sensors.

[0015] According to some embodiments, the method may include monitoring and / or regulating the flow capacity of the medical substance and / or flushing fluid entering the blood vessel using one or more sensors.

[0016] According to some embodiments, the method may include regulating, with the controller, the pressure and / or flow rate of the flushing fluid and / or the medical substance.

[0017] According to some embodiments, a peripherally insertable central catheter (PICC) is provided, the catheter being configured to be inserted into a blood vessel and including a distal portion including a distal end opening, a proximal portion including a proximal end opening, at least one flushing lumen extending therebetween, and a valve disposed within the at least one flushing lumen, the valve having two configurations, an open configuration that allows fluid flow through the distal end opening, and a closed configuration that blocks fluid flow through the distal end opening, the valve in its closed configuration preventing flushing fluid entered into the catheter from its proximal opening from circulating through the proximal portion and exiting the blood vessel of a subject, thereby discharging flushing fluid via the distal end opening.

[0018] According to some embodiments, there is provided a method of flushing a peripherally insertable central catheter (PICC), the method comprising the steps of: preparing a PICC including a distal portion including a distal end opening, a proximal portion including a proximal opening, at least one flushing lumen extending therebetween, and a valve disposed within the at least one flushing lumen; inserting the distal portion of the PICC into a blood vessel of a subject; shifting the valve to a closed configuration to block fluid flow through the distal end opening; and injecting a flushing fluid into the catheter through the proximal opening, thereby preventing the flushing fluid from circulating back through the proximal portion and exiting the catheter through the distal end opening and into the blood vessel of the subject.

[0019] According to some embodiments, the at least one flushing lumen is further configured to deliver a medical substance to the subject in the open configuration of the valve.

[0020] According to some embodiments, the at least one flushing lumen is divided into two separate lumens, a first lumen configured to deliver flushing fluid and a second lumen configured to collect flushing fluid, direct it to the proximal portion, and drain it out of the subject's blood vessel.

[0021] According to some embodiments, the valve includes an expandable element configured to expand to a size sufficient to seal the distal end opening.

[0022] According to some embodiments, the catheter further includes an inflation conduit in fluid flow communication with the expandable element.

[0023] According to some embodiments, the valve includes a sealing flap and / or shutter configured to controllably seal the distal end face opening.

[0024] According to some embodiments, the valve includes a duckbill valve configured to controllably seal the distal end face opening.

[0025] According to some embodiments, the valve may include a skirt valve configured to controllably seal the distal end opening.

[0026] According to some embodiments, the valve may include a guidewire valve configured to controllably seal the distal end face opening. According to some embodiments, the guidewire valve is a guidewire actuated valve such that when the guidewire is pushed distally, the guidewire valve shifts to a closed configuration, thereby sealing off the distal end face of the PICC, and when the guidewire is pulled proximally, the guidewire valve shifts to an open configuration, thereby allowing fluid flow through the distal opening in the distal end face of the PICC.

[0027] According to some embodiments, the valve may include a piston configured to controllably seal the distal end opening. According to some embodiments, the piston may be actuated by a wire such that pushing the wire distally shifts the piston to a closed configuration, thereby sealing off the distal end face of the PICC, and pulling the piston proximally shifts the piston to an open configuration, thereby allowing fluid flow through the distal opening in the distal end face of the PICC.

[0028] According to some embodiments, the catheter further comprises an additional separate lumen for delivering a medical substance to the subject in the open configuration of the valve.

[0029] According to some embodiments, flushing fluid returned through the proximal portion exits the catheter through the proximal opening.

[0030] According to some embodiments, flushing fluid returned through the proximal portion exits the catheter through a proximal drain port.

[0031] According to some embodiments, the catheter further includes a pressure adjustment mechanism configured to regulate the flow rate of flushing fluid to facilitate circulation of the flushing fluid through the at least one flushing lumen, back through the proximal portion, and out of the catheter.

[0032] According to some embodiments, the catheter includes a flushing lumen, a lumen for manipulating the valve, a lumen for delivering a medical substance, and a lumen including a duckbill valve to facilitate separation of the medical substance.

[0033] According to some embodiments, the catheter further includes one or more sensors for monitoring and / or regulating the pressure of the flushing fluid to facilitate pressure regulation.

[0034] According to some embodiments, the catheter further includes one or more sensors for monitoring and / or regulating the flow volume of flushing fluid entering the catheter and / or exiting the catheter.

[0035] According to some embodiments, the catheter further includes one or more sensors for monitoring and / or regulating the flow volume of the medical substance entering the blood vessel.

[0036] According to some embodiments, the method further comprises analyzing the flushing fluid for chemical and / or biological substances indicative of complications and / or infection.

[0037] According to some embodiments, analyzing the flushing fluid includes identifying blood clots and / or bacteria.

[0038] According to some embodiments, the method further includes analyzing one or more parameters related to the pressure of the flushing fluid exiting and / or entering the catheter to evaluate a performance quality of the catheter and / or the flushing fluid.

[0039] According to some embodiments, the method further comprises monitoring and / or regulating the pressure of the flushing liquid using one or more sensors.

[0040] According to some embodiments, the method further includes monitoring and / or regulating the flow volume of flushing fluid entering and / or exiting the catheter using one or more sensors.

[0041] According to some embodiments, the method further includes monitoring and / or regulating the flow volume of the medical substance entering the blood vessel using one or more sensors.

[0042] According to some embodiments, the method further includes regulating, with the controller, a pressure and / or a flow rate of the flushing fluid and / or the medical substance.

[0043] Unless otherwise defined, all technical and scientific terms used herein have the same meaning as commonly understood by those skilled in the art to which this disclosure pertains. In case of conflict, the patent specification, including definitions, shall prevail. As used herein, the indefinite articles "a" and "an" mean "at least one" or "one or more," unless the context clearly dictates otherwise. [Brief description of the drawings]

[0044] Some embodiments of the present disclosure are described herein with reference to the accompanying drawings. The description together with the drawings will make clear to those skilled in the art how some embodiments can be implemented. The drawings are for illustrative purposes and are not intended to show structural details of the embodiments in more detail than is necessary for a basic understanding of the present disclosure. For clarity, some of the things depicted in the figures may not be drawn to scale. Furthermore, two different objects in the same figure may be drawn to different scales. In particular, the scale of some objects may be greatly exaggerated compared to other objects in the same figure.

[0045] In the block diagrams and flow charts, optional elements / components and steps may be included within dashed boxes.

[0046] [Figure 1] FIG. 1 is a schematic diagram of a prior art PICC introduced into a subject's blood vessel. [Diagram 2] FIG. 2 shows a schematic of a prior art PICC. [Diagram 3] FIG. 3 illustrates a schematic side view of a distal portion of a valved PICC, according to some embodiments. [Figure 4A] FIG. 4A illustrates a schematic perspective view of a distal portion of a PICC, according to some embodiments. [Figure 4B] FIG. 4B illustrates a schematic cross-sectional view of the distal portion and distal end face of the PICC of FIG. 4A, according to some embodiments. [Figure 5A] FIG. 5A illustrates a schematic perspective view of a distal portion of a PICC according to some embodiments. [Figure 5B] FIG. 5B illustrates a schematic perspective view of a distal portion of the PICC of FIG. 5A in a closed valve configuration, according to some embodiments. [Figure 6A] FIG. 6A illustrates a schematic side view in cross section of a distal portion of a PICC in an open valve configuration, according to some embodiments. [Figure 6B] FIG. 6B illustrates a schematic side view of a cross section of a distal portion of a PICC in a closed valve configuration, according to some embodiments. [Figure 7A] FIG. 7A illustrates a schematic side view in cross section of a distal portion of a PICC in an open valve configuration, according to some embodiments. [Figure 7B] FIG. 7B illustrates a schematic side view of a cross section of a distal portion of a PICC in a closed valve configuration, according to some embodiments. [Figure 8A] FIG. 8A illustrates a schematic side view in cross section of a distal portion of a PICC in an open valve configuration, according to some embodiments. [Figure 8B] FIG. 8B illustrates a schematic side view of a cross section of a distal portion of a PICC in a closed valve configuration, according to some embodiments. [Figure 9A] FIG. 9A illustrates a schematic side view of a cross section of a distal portion of a PICC in an open valve configuration, according to some embodiments. [Figure 9B] FIG. 9B illustrates a schematic side view in cross section of a distal portion of a PICC in a closed valve configuration according to some embodiments. [Figure 10] FIG. 10 illustrates a flow chart of a method for flashing a PICC according to some embodiments. DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENTS

[0047] The principles, uses, and implementations of the teachings herein may be better understood with reference to the accompanying description and drawings. Upon review of the description and drawings herein, one skilled in the art will be able to practice the teachings herein without undue effort or experimentation. In the drawings, like reference numerals refer to like parts throughout.

[0048] In the following description, various aspects of the present invention are described. For purposes of explanation, specific details are set forth in order to provide a thorough understanding of the present invention. However, it will be apparent to one skilled in the art that the present invention may be practiced without the specific details presented herein. Furthermore, well-known features may be omitted or simplified in order not to obscure the present invention.

[0049] The present invention, in some embodiments thereof, relates to catheters, and more particularly to peripherally inserted central catheters (PICCs), methods and devices for introducing and removing fluids from blood vessels and / or body organs.

[0050] The disclosed PICC, according to some embodiments, is configured to deliver medical agents to a subject in an open valve configuration. The medical agents may include drugs, such as cytotoxic drugs for cancer treatment, antibiotic drugs, etc., blood, nutrients.

[0051] According to some embodiments, the disclosed PICC can be implemented for medical substance delivery, and can optionally be implemented for simultaneous delivery of multiple medical substances, and can be implemented to prevent undesired mixing of medical substances before entering blood vessels and / or body organs. In some cases, flushing of the PICC can be implemented following delivery of medical substances. An aspect of some embodiments of the present invention relates to a catheter including a PICC having a distal portion, a proximal portion, a valve, and at least one flushing lumen extending between the distal portion and the proximal portion. The valve disposed in the at least one flushing lumen has at least two configurations, namely, an open configuration that allows fluid flow through the distal end face opening, and a closed configuration that blocks fluid flow through the distal end face opening. Thus, in the closed valve configuration, fluids admitted through the proximal end face opening circulate back and exit the catheter through the proximal drain port. The effluent, e.g., the circulated fluid, can be further analyzed for identification of bacteria, clotting factors, and contaminants, and the catheter function and / or the medical condition of the subject can be evaluated.

[0052] According to some embodiments, the at least one flushing lumen may be a lumen within which fluid flows in at least one direction between the distal end face opening and the proximal drain orifice. According to some embodiments, the at least one flushing lumen may be configured to allow fluid flow in at least two directions between the distal end face opening and the proximal drain orifice. According to some embodiments, the at least one flushing lumen may include a plurality of separate lumens. According to some embodiments, the at least one flushing lumen may be divided into a plurality of separate lumens. According to some embodiments, the at least one flushing lumen may be divided into a plurality of separate lumens, where a first lumen may be configured to deliver flushing fluid and a second lumen may be configured to receive and direct flushing fluid to a proximal portion and out of a blood vessel and / or body organ of a subject. According to some embodiments, the plurality of separate lumens may be in fluid communication.

[0053] According to some embodiments, the at least one flushing lumen includes a valve. According to some embodiments, the valve may include any element configured to prevent fluid flow from the PICC assembly to the blood vessel and / or vice versa.

[0054] According to some embodiments, the valve disposed in at least one flushing lumen can be located inside the inner distal portion of the PICC. According to some embodiments, the valve may be disposed on the distal end face of the PICC. According to some embodiments, and as described in more detail elsewhere herein, the valve may be disposed between the cavity defined by the closed arrangement of the valve, the inner wall of the PICC, and the distal end of the multiple individual lumens, and may allow circulation of fluid within the cavity at the distal portion of the PICC and outside the multiple individual lumens. Following circulation, the fluid (e.g., flushing fluid) is directed back toward the proximal end, out of the catheter, and out of the subject's body.

[0055] According to some embodiments, the valve may include an expandable element, such as a balloon, configured to expand to a size sufficient to seal the distal end face opening, thereby preventing the flow of fluid to the blood vessel and / or body organ. According to some embodiments, sealing of the PICC may require the expandable element to be fully or partially expanded (in a closed configuration). According to some embodiments, the expandable element may be positioned entirely inside and / or partially inside, or entirely outside, the distal end face of the PICC when in a closed (inflated) configuration. According to some embodiments, the valve may include rings (e.g., external and / or internal rings) located on the outer and / or inner circumference of the at least one flushing lumen, configured to shift between the open and closed configurations. For example, the rings may govern the closed configuration by decreasing the circumference of the at least one flushing lumen until no fluid can enter or leave the distal end face of the PICC assembly. Or, the rings may govern the open configuration by increasing the circumference of the flushing lumen to allow fluid to enter or leave through the distal end face. According to some embodiments, at least one flushing lumen may include a groove configured to retain a ring, providing a smooth exterior surface of the flushing lumen. A smooth exterior and / or interior surface area is beneficial for minimizing the accumulation of undesirable material and deposits on the exterior and / or interior surface area of ​​the lumen, as well as reducing the risk of infection, bacterial growth, and various contaminants.

[0056] According to some embodiments, the distal portion of the PICC assembly may include an angular distal end surface. The angular distal end surface may include a conus-like shape, where the diameter of at least one flushing lumen decreases at the distal end surface. A valve may be disposed at the conus-like distal end surface, where the valve is configured to shift from an open configuration and a closed configuration (and vice versa) as needed. The positioning of the valve may be mechanically governed, for example, by applying mechanical pressure to hold and position the valve at the narrowest region of the cone at the angular distal end surface.

[0057] According to some embodiments, the valve may include a sealing flap and / or shutter configured to controllably seal the distal end face opening. Preferably, sealing occurs quickly to minimize leakage from and / or into the catheter. Optionally, a service conduit may be permanently placed in the at least one flushing lumen, e.g., in the service lumen, in the distal portion of the PICC. Optionally or alternatively, a service conduit may be temporarily placed inside the at least one flushing lumen, so that the service conduit may be removed after a shift in valve placement. The service conduit may extend to a degree that reaches the proximal end face of the PICC assembly, thereby allowing external control of the placement of the valve, e.g., to control the valve and / or to apply mechanical pressure to the valve. According to some embodiments, a service conduit placed inside the service lumen may prevent fluid communication between the at least one flushing lumen of the PICC and the service lumen. From another perspective, when a service lumen is associated with a service conduit (eg, due to expansion / contraction of an expandable element by gas flow), fluid may not enter and / or exit the service lumen.

[0058] According to some embodiments, the service conduit may be associated with a valve, in which case the diameter of at least one flushing lumen may be reduced until no gap is present at the distal end face, sealing off the distal end face and preventing fluid ingress.

[0059] According to some embodiments, the catheter may include a pressure regulation mechanism configured to regulate and / or monitor the flow rate of the flushing fluid to facilitate circulation of the flushing fluid through at least one flushing lumen. Furthermore, because the volume of administered fluid is relatively high relative to the surface area of ​​the catheter (long, thin lumen), a pressure regulation mechanism may be required to provide optimal power flow. The pressure regulation mechanism may include, for example, a pump and / or pumping system for injecting fluid and / or expelling fluid.

[0060] According to some embodiments, the catheter may include a valve (e.g., a balloon valve), a flushing lumen, a service lumen, and a lumen with a duckbill valve. The flushing lumen may be utilized for delivery of nutritional supplements and / or flushing purposes, the service lumen may be utilized for manipulating the placement of the valve, and the lumen with the duckbill valve may be applied to administer, for example, cytotoxic drugs to a subject. The duckbill valve may also be any type of control valve, including a control valve for regulating the inflow and outflow of fluids, a control valve for facilitating separation of medical substances and minimizing residue formation inside the catheter. Furthermore, the actuation mechanism of the duckbill valve is technically simple, and therefore the use of such a catheter by a subject may be advantageous in that it allows independent operation without the need to go to a medical facility.

[0061] Optionally, in some embodiments, the catheter may include one or more sensors that allow for pressure regulation and / or monitoring of the flushing fluid, thereby facilitating pressure regulation within the lumen of the catheter. In some embodiments, the one or more sensors may regulate and / or monitor the flow rate of the flushing fluid and / or medical substance into and / or out of the catheter.

[0062] Reference is made to Figure 1, which illustrates a prior art schematic of a peripherally insertable central catheter (PICC) 100 introduced into a subject's blood vessel 102. The PICC 100 is positioned within the blood vessel 102, here in the subject's upper arm 104, and is configured to deliver a medical substance (not shown) via the blood vessel 102 into a body organ, such as a heart 108.

[0063] Reference is now made to Figure 2, which illustrates a schematic of a standard PICC 200 according to the prior art. The standard PICC 200 has a distal portion 210 configured to be inserted into a blood vessel. Optionally, the distal portion 210 may include a soft tip 211 to minimize the risk of trauma to the blood vessel. The proximal portion 220 of the PICC 200 may optionally include three separate lumens, lumens 216a, 216b, and 216c. Each of the lumens 216a, 216b, and 216c is associated with an adapter 223 configured to connect a catheter line 225 to each of the lumens 216a, 216b, and 216c. Each of the lumens 216a, 216b, and 216c includes a clamp 217a, 217b, and 217c, respectively, configured to allow temporary sealing (e.g., for minutes, hours, or days) at the proximal end 220 without removing the PICC 200 from the blood vessel. Additionally, each of the lumens 216a, 216b, and 216c includes a connector 219a, 219b, and 219c. The connectors 219a, 219b, and 219c may be needleless connectors that allow temporary association with an IV and / or syringe and / or external tube or lumen configured to deliver medical substances and / or other fluids (e.g., flushing fluid) into the PICC 200. As shown in FIG. 2, the connectors 219a and 219c may be associated with removable caps 221a and 221c to reduce the risk of infection. For example, a syringe (not shown) may be coupled to lumen 216a via connector 219a at the proximal portion of PICC 200. Clamp 217 may then be opened to allow the medical substance from the syringe to be administered to PICC 200, flow through adapter 223, catheter line 225, and into the blood vessel via distal portion 210. After administration of the medical substance, the catheter is flushed to remove contaminants, bacteria, etc., especially if administration of several medical substances is required. The flushing procedure is typically performed by inserting a flushing fluid, such as a saline solution, into one of the lumens (e.g., lumen 216c) at the proximal end 220 of PICC 200.Upon reaching the distal portion 210, the flushing fluid containing contaminants, clotting factors, bacteria, etc. is delivered to the subject's blood vessels and / or body organs. Delivery of contaminants to the subject increases the risk of infection and health problems.

[0064] Reference is now made to FIG. 3, which shows a schematic diagram of a distal portion 310 of a PICC 300, according to some embodiments. The PICC 300 is designed to facilitate circulation of flushing fluid, thereby preventing waste fluid from being discarded into the body organs, thus limiting, reducing, or eliminating the administration of bacteria, contaminants, and / or sediments from the flushing fluid into the subject. According to some embodiments of the present disclosure, the distal portion 310 includes a distal end face 312, a distal opening 314, separate lumens 316a and 316c, and a valve 318. The lumens 316a and 316c extend along the PICC 300 from its proximal portion (not shown) to the distal portion 310. 3, the lumens 316a and 316c do not reach the distal end surface 312, thereby forming a cavity 322 defined by the inner wall of the PICC 300, the distal ends of the lumens 316a and 316c, and the valve 318. According to some embodiments, the valve 318 is disposed inside the cavity 322. According to some embodiments, flushing fluid is inserted through the lumen 316a from the proximal end (not shown) of the PICC 300, and then when the valve 318 is in a closed configuration, the flushing fluid is circulated in the distal portion 310 and discharged from the exterior proximal end (not shown) of the PICC 300 through the lumen 316c. According to some embodiments, the flushing fluid may be introduced through the proximal end (not shown) of the lumen 316c, circulated in the distal portion 310, and then discharged from the exterior proximal end (not shown) of the PICC 300 through the lumen 316a. In other embodiments, the flushing fluid may be discharged outside the body from each of lumens 316a and 316c.

[0065] According to some embodiments, the cross-sectional size (e.g., diameter) of lumen 316a may be different and / or equal to the cross-sectional size of lumen 316c. According to some embodiments, the cross-sectional size of lumens 316a / 316c may correlate to the flow rate of fluid therethrough. According to some embodiments, the cross-sectional sizes of lumens 316a / 316c may be different. According to some embodiments, the cross-sectional sizes of lumens 316a / 316c may vary. According to some embodiments, a configuration in which lumens 316a and 316c have different cross-sectional sizes may induce a pressure differential between lumens 316a and 316c, thereby enabling a desired flow rate in each of the lumens.

[0066] According to some embodiments, the wall thickness of each of the lumens 316a / 316c may be different. According to some embodiments, the wall thickness of at least one of the lumens 316a / 316c may vary. Advantageously, if the lumens 316a / 316c have different and / or varying wall thicknesses, a desirable pressure differential can be provided for the fluid therein. According to some embodiments, if the lumens 316a / 316c have different and / or varying wall thicknesses, the durability of the PICC can be increased.

[0067] For some embodiments, reference is made to Figures 4A and 4B. Figure 4A shows a schematic diagram of a perspective view of a distal portion 410 of a PICC 400, and Figure 4B shows a cross-sectional view of the distal portion 410 and distal end face 412 of the PICC 400. The distal portion 410 includes a distal opening 414 located at the distal end face 412 of the PICC 400. The PICC 400 includes a separate lumen 416a, a separate lumen 416c, and may optionally also include a separate lumen 416b. According to some embodiments, the lumen 416b may include one or more separate lumens. The lumens 416a, 416b, and 416c extend along the PICC 400 from its proximal portion (not shown) to the distal portion 410. As also seen in FIG. 3, the lumens 416a, 416b and 416c do not reach the distal end surface 412, forming a cavity 422 defined by the inner wall of the PICC, the distal ends of the lumens 416a, 416b and 416c and the valve 418 (as depicted in FIG. 4B). According to some embodiments, the lumen 416a may be utilized as a medical substance administration route, the lumens 416a and 416c may be utilized as flushing lumens, while the lumen 416b may be utilized as a service lumen for the operation of a distal valve (e.g., valve 418 as shown in FIG. 4B). In other words, the lumen 416a may serve as both a medical substance administration lumen and a flushing lumen. According to some embodiments, each of the lumens 416a to 416c may independently be implemented as a medical substance administration lumen and / or as a flushing lumen and / or as a service lumen. In some embodiments, if a service lumen is present (eg, lumen 416b), the service lumen may preferably be utilized only to operate the valve.

[0068] Reference is now made to FIG. 4B, which shows a schematic diagram of a cross-sectional view of the distal portion 410 of the PICC 400 depicted in FIG. 4A, according to some embodiments. According to some embodiments, the PICC 400 includes multiple separate lumens, namely separate lumen 416a and separate lumen 416c. FIG. 4B shows a schematic flow direction 420 of flushing fluid introduced from a proximal end face (not shown) of the PICC 400, for example into lumen 416a. As shown in FIG. 4B, the closed configuration of the valve 418 results in circulation of the flushing fluid, with fluid flow from lumen 416a to lumen 416c. Fluid from lumen 416a flows from the proximal end of the PICC towards the valve 418 (and / or towards the distal end of the PICC). Valve 418, in its closed configuration, restricts the flow of fluid from lumen 416a out of the distal end of the PICC, thereby forcing the fluid to circulate into lumen 416c, as indicated by arrow 420. The closed configuration of valve 418 thus prevents the inflow of flushing fluid into the blood vessel / body organ and allows the flushing fluid to drain out of the blood vessel and / or body organ, thus reducing the risk of infection and other medical complications.

[0069] According to some embodiments, the multiple individual lumens may include one or more valves, such as duckbill valves (not shown). The one or more valves are configured to prevent circulating fluid from entering the distal end of the one or more individual lumens and flow toward the proximal end thereof. As a non-limiting example, the PICC 400 may include multiple lumens, such as four individual lumens, with a first lumen 416a (i.e., flushing lumen) configured to deliver flushing fluid, a second lumen 416c (i.e., flushing lumen) configured to receive the flushing fluid and direct it to the distal end and outside of the subject, and lumen 416b including two individual lumens, a first individual lumen and a second individual lumen, with the first individual lumen (not shown) optionally configured to operate a valve 418 and the second individual lumen (not shown) including one or more valves and optionally configured to deliver a medical substance that should not be mixed with other substances and / or fluids. When the valve 418 shifts from an open state to a closed state, the flushing fluid entering the first lumen 416a circulates inside the cavity 422. That is, the flushing fluid changes direction from the distal portion 410 of the PICC toward the proximal portion (not shown). Thus, to prevent circulating fluid from entering the second separate lumen, the second separate lumen may include one or more valves. According to some embodiments, the one or more valves may be disposed inside the second separate lumen. According to some embodiments, each of the multiple lumens may include one or more valves.

[0070] Reference is now made to Figures 5A and 5B, which show schematic perspective views of a distal portion 510 of a PICC 500 in an open valve configuration 520 (depicted in Figure 5A) and a closed valve configuration 518 (depicted in Figure 5B), respectively. The distal portion 510 includes a distal opening 514 located at a distal end face 512 of the PICC 500. According to some embodiments, the PICC 500 includes a separate lumen 516a, a separate lumen 516b, and a separate lumen 516c, as well as a cavity 522 formed between the distal ends of the lumens 516b and 516c and the distal end face 512 of the PICC 500, and a valve 524 disposed inside the cavity 522. According to some embodiments, the lumen 516c may act as a service lumen and may include a service conduit 528. In some embodiments, the service conduit 528 may control the position of the valve 522 to shift (e.g., from a closed valve position 518 to an open valve position 520 and vice versa). In some embodiments, the service conduit 528 may aid in administering the PICC 500 to a blood vessel and / or body organ. For example, while catheters are typically made of soft materials that are not visible in x-ray images, the service conduit 528 may be made of a material that aids in viability and stability in x-rays, making it easier and more appropriate to position the PICC 500 inside the blood vessel and / or body organ. As depicted in FIG. 5A, the open valve position 520 allows for the administration of a medical substance to the blood vessel and / or body organ of a subject.

[0071] As shown in FIG. 5B, the valve 524 may include a balloon 526. According to some embodiments, in the closed configuration 518, the valve 524 (or the balloon 526) may be at least partially inflated. According to some embodiments, in the closed configuration 518, the valve 524 may be inflated such that the balloon 526 occludes the distal end of the PICC. According to some embodiments, the PICC may include a service conduit 528 configured to deliver fluid (e.g., gas) to and / or from the balloon 526. According to some embodiments, the service conduit 528 may be in fluid communication with the balloon 526. According to some embodiments, the service conduit 528 may be disposed within the lumen 516c. According to some embodiments, the service conduit 528 may be disposed on and / or against the outer wall of the PICC. Advantageously, the inflated balloon valve may prevent flushing fluid from exiting the distal opening 514 and entering a blood vessel and / or body organ. Advantageously, when the PICC is in a standby state and the balloon 526 of the valve 524 is inflated, it may prevent indwelling infection from returning from the body to one or more lumens.

[0072] Reference is now made to Figures 6A and 6B, which show schematic cross-sectional side views of a distal portion 610 of a PICC 600 in an open valve configuration 620 (depicted in Figure 6A) and a closed valve configuration 618 (depicted in Figure 6B), respectively, according to some embodiments.

[0073] According to some embodiments, the following components / features 600, 610, 612, 614, 616a-c, 622, and 624 in Figures 6A and 6B correspond to components 500, 510, 512, 514, 516a-c, 522, and 524 in Figure 5 and described herein and may have the same or similar structure, configuration and / or characteristics.

[0074] According to some embodiments, and as depicted in FIGS. 6A and 6B, the distal portion 610 of the PICC 600 may include, among others, a circular or circular-like structure. Alternatively, the distal portion 610 of the PICC 600 may include, but is not limited to, an angular structure, such as a pyramidal, rectangular, polynomic structure, or any combination thereof. According to some embodiments, the PICC 600 includes a separate lumen 616a, a separate lumen 616b, and a separate lumen 616c. According to some embodiments, the PICC 600 may include two separate lumens (e.g., separate lumens 616a and 616b). According to some embodiments, the PICC 600 may include three or more separate lumens. Each possibility is a separate embodiment.

[0075] According to some embodiments, the PICC 600 includes a cavity 622 formed between the distal ends of the individual lumens 616ba, 616b, and 616c and the distal end face 512 of the PICC 600, and a valve 624 disposed inside the cavity 622. According to some embodiments, the valve 624 includes an expandable element, such as a balloon 626, that can expand to a size sufficient to block the distal opening 614, thereby preventing the flow of fluid to a blood vessel and / or body organ. According to some embodiments, the PICC 600 may include an inflation conduit (e.g., in the individual lumen 616c) in fluid flow communication with the expandable element. According to some embodiments, inflation and deflation of the expandable element may be performed via the inflation conduit. According to some embodiments, the balloon 626 may be inflated with a liquid, such as, but not limited to, a saline solution. According to some embodiments, inflation of the balloon 626 may be performed at a proximal portion (not shown) of the PICC 600.

[0076] According to some embodiments, and as depicted in FIGS. 6A and 6B , the balloon 626 is partially disposed within the cavity 622 and partially disposed within the individual lumen 616c. According to some embodiments, the balloon 626 may be disposed outside the individual lumen 616c. According to some embodiments, the balloon 626 may be disposed outside the individual lumen 616c. As a non-limiting example, the balloon 626 may be disposed on an outer portion of the individual lumen 616c. As yet another non-limiting example, the balloon 626 may be disposed essentially within the cavity 622.

[0077] 6B, the closed valve arrangement 618 of the balloon 626 includes at least a partial inflation thereof to essentially fill the cavity 622, thereby preventing fluid from entering therein. Additionally or alternatively, in some embodiments, the closed valve arrangement 618 may comprise filling the distal portions of each of the individual lumens 616a and 616b in addition to filling the cavity 626.

[0078] According to some embodiments, the closed valve arrangement 618 includes at least partial inflation of a balloon 626 that extends outside the distal end surface 612. According to some embodiments, in the closed valve arrangement 618, the balloon 626 is inflated by occupying only the inter components of the PICC 600 (e.g., by filling the cavity 622).

[0079] According to some embodiments, the separate lumen 616c is a service lumen configured to control and actuate a shift configuration (i.e., open / closed) of the valve 624. According to some embodiments, the separate lumen 616c is a service lumen configured to control an inflation / deflation configuration of the balloon 626. According to some embodiments, the PICC 600 may include or be associated with a service conduit disposed inside the separate lumen 616c. According to some embodiments, the service conduit may be in fluid communication with the valve 624. According to some embodiments, the service conduit may control a shift configuration of the valve 624 (e.g., from a closed valve configuration 618 to an open valve configuration 620, and vice versa). In some embodiments, the service conduit may aid in application of the PICC 600 to a blood vessel and / or a body organ.

[0080] According to some embodiments, the valve shifting mechanism can be controlled and / or implemented by manual (e.g., by a caregiver and / or the subject) or mechanical actuation of the valve 624 at the proximal end of the PICC 600. Alternatively or additionally, the valve shifting mechanism may be implemented automatically, for example by sensor control.

[0081] 7A and 7B, according to some embodiments, show schematic cross-sectional side views of a distal portion 710 of a PICC 700 in an open valve configuration 720 (depicted in FIG. 7A) and a closed valve configuration 718 (depicted in FIG. 7B), respectively.

[0082] According to some embodiments, the following components / features 700, 710, 712, 714, and 716a-c depicted in Figures 7A and 7B correspond to components 600, 610, 612, 614, and 616a-c described herein in Figures 6A and 6B and may have the same or similar structure, configuration, and / or characteristics.

[0083] According to some embodiments, a cavity 722 is formed between the distal ends of the individual lumens 716a and 716c and the distal end face 712 of the PICC 600, with a valve 724 disposed inside the cavity 722.

[0084] According to some embodiments, the valve 724 includes a sealing flap and / or shutter configured to controllably seal the distal end face opening. According to some embodiments, the sealing flap and / or shutter may be in the form of a skirt valve 726.

[0085] According to some embodiments, the valve 724 includes a skirt valve 726 configured to controllably seal the distal opening 714. According to some embodiments, the skirt valve 726 may be fused or otherwise integrally formed to the distal end of the outer surface of the individual lumen 716c. According to some embodiments, the skirt valve 726 may be separably associated with the individual lumen 716c. According to some embodiments, the skirt valve 726 includes a rim 728 such that in an open valve configuration 720, the rim 728 is essentially vertically disposed, allowing fluid to pass therethrough, and in a closed valve configuration 718, the rim 728 is in a downwardly inclined position, thereby preventing fluid from passing therethrough. Alternatively or additionally, in some embodiments, the closed valve configuration 718 may include an upwardly inclined position. As shown in some embodiments and in FIG. 7B, sealing off of the PICC 900 by the skirt valve 826 includes internally sealing off each of the individual lumens 716a and 716b. According to some embodiments, the closed configuration 718 of the skirt valve 726 may include sealing off the cavity 722.

[0086] According to some embodiments, and not wishing to be bound to any particular mechanism, the skirt valve 726 may be actuated via a service conduit (not shown) disposed within a separate lumen 716c. As a non-limiting example, the service conduit may be associated with a wire, among other things, where pushing the wire distally shifts the rim 728 to a downwardly angled position (i.e., closed configuration 718) sealing off the distal end face 712 of the PICC 700, and pulling the wire proximally shifts the rim 728 to a substantially vertical position (i.e., open configuration 720), thereby allowing fluid flow through a distal opening in the distal end face of the PICC.

[0087] According to some embodiments, the placement of the skirt valve 726 may be mechanically or manually actuated (e.g., by the subject and / or healthcare provider) from the proximal end of the PICC 700 and / or may be automatically actuated, for example, by sensor control. As a non-limiting example, the configuration of the skirt valve 726 may be controlled by actuating a service conduit (not shown) disposed within the individual lumen 716c.

[0088] Reference is now made to Figures 8A and 8B, which, according to some embodiments, show schematic cross-sectional side views of a distal portion 810 of a PICC 800 in an open valve configuration 820 (depicted in Figure 8A) and a closed valve configuration 818 (depicted in Figure 8B), respectively.

[0089] According to some embodiments, and as depicted in FIGS. 8A and 8B, the distal portion 810 of the PICC 800 includes, but is not limited to, an angular shaped structure, such as a pyramidal structure. Alternatively, in some embodiments, the distal portion 810 may include a circular or round structure. According to some embodiments, the PICC 800 includes a separate lumen 816a, a separate lumen 816b, and a separate lumen 816c. According to some embodiments, the separate lumen 816c is a service lumen. According to some embodiments, the PICC 800 may include two separate lumens. According to some embodiments, the PICC 800 may include three or more separate lumens. Each possibility is a separate embodiment.

[0090] According to some embodiments, a cavity 822 is formed between the distal ends of the individual lumens 816 a , 816 b and 816 c and the distal end face 812 of the PICC 800 , and a valve 824 is disposed inside the cavity 822 .

[0091] According to some embodiments, the valve 824 includes a guidewire valve 826 configured to controllably seal the distal opening 814. According to some embodiments, the guidewire valve 826 includes a cap 832, a resilient valve member 830, and is separably or permanently associated with a guidewire 828.

[0092] According to some embodiments, the guidewire valve 826 is a valve that is actuated by the guidewire 828 such that pushing the guidewire 828 distally causes the guidewire valve 826 to a closed configuration 820, thereby sealing off the distal end face 812 of the PICC 800, and pulling the guidewire 828 proximally causes the guidewire valve 826 to an open configuration 818, thereby allowing fluid flow through a distal opening 814 in the distal end face 812.

[0093] According to some embodiments, guidewire valve 826 may be fused or otherwise integrally formed with the outer surface of the distal end of individual lumen 816c. By way of non-limiting example, at least a portion of resilient valve member 830 may be associated with the distal end of individual lumen 816c. According to some embodiments, guidewire valve 826 may be detachably associated with individual lumen 816c.

[0094] According to some embodiments, guidewire valve 826 may be inserted into PICC 800 only if sealing is desired. Alternatively, in some embodiments, guidewire valve 826 may be positioned within the PICC in both the open and closed configurations 818 and 820, respectively.

[0095] According to some embodiments, guidewire valve 826 includes or is made of a flexible, resilient and / or soft material, such as, but not limited to, a polymer. According to some embodiments, cap 832 and resilient member 830 include or are made of a different material than guidewire 828. According to some embodiments, guidewire 828 may include or be made of a material that has a lower flexibility relative to cap 832 and / or resilient member 830. According to some embodiments, guidewire 828 is made of a metal, including, but not limited to, a metal, such as aluminum.

[0096] According to some embodiments, the cap 832 is configured to seal against the distal end surface 812 of the PICC 800, and thus, according to some embodiments, the structure of the cap 832 is geometrically complementary to at least a portion of the distal opening 814 and / or the distal end surface 812. According to some embodiments, the cap 832 includes, among other things, an angular structure (e.g., pyramidal, conical, etc.) that facilitates sealing against the distal end surface 812 of the PICC 800.

[0097] According to some embodiments, the resilient valve member 830 is disposed against an exterior portion of a lumen, such as individual lumen 816c. Alternatively, or additionally, in some embodiments, at least a portion of the resilient valve member 830 may be disposed inside individual lumen 816c. According to some embodiments, the guidewire valve 826 may be associated with a guidewire 828 disposed inside individual lumen 816c to shift the disposition of the guidewire valve 826.

[0098] As shown in some embodiments and in FIG. 8A, in the open valve configuration, the resilient valve member 830 is at least partially collapsed, allowing fluid to pass through the distal opening 814 of the distal end face 812 of the PICC 800. According to some embodiments, in the open valve configuration 818, the cap 832 is at least partially located inside the cavity 822. As shown in some embodiments and in FIG. 8B, in the closed valve configuration, the resilient valve member 830 is pushed distally (e.g., by stretching, deploying, etc., of the resilient member 830) such that the cap 832 seals against the distal end face 812 of the PICC 800.

[0099] According to some embodiments, placement of the guidewire valve 826 may be mechanically actuated from the proximal end of the PICC 800 and / or may be automatically actuated, for example by sensor control. According to some embodiments, the implementation of the guidewire valve 826 preferably allows for technically simple actuation of the PICC 800 and reduces the risk of occlusion.

[0100] Reference is now made to Figures 9A and 9B, which show schematic cross-sectional side views of a distal portion 910 of a PICC 900 in an open valve configuration 920 (depicted in Figure 9A) and a closed valve configuration 918 (depicted in Figure 9B), respectively, according to some embodiments.

[0101] According to some embodiments, the following components / features 900, 910, 912, 914, and 916a-c in FIGS. 9A and 9B correspond to components 800, 810, 812, 814, and 816a-c described herein in FIGS. 8A and 8B and may have the same or similar structure, configuration, and / or characteristics.

[0102] According to some embodiments, a cavity 922 is formed between the distal ends of the individual lumens 916 a , 916 b , and 916 c and the distal end face 912 of the PICC 900 , and a valve 924 is disposed inside the cavity 922 .

[0103] According to some embodiments, the valve 924 includes a piston 926 configured to controllably seal the distal opening 914. According to some embodiments, and as depicted in Figures 9A and 9B, the piston 926 is partially disposed within a separate lumen 916c. According to some embodiments, the piston 926 includes or is constructed of a rigid or semi-rigid material (e.g., including but not limited to, a polymer, a metal, or the like).

[0104] According to some embodiments, the piston 926 may be actuated by a wire or any other suitable pushing means (not shown), where pushing the wire distally shifts the piston 926 to a closed configuration 920, thereby sealing the distal end face 912 of the PICC 900, and pulling the wire proximally shifts the piston 926 to an open configuration 918, thereby allowing fluid flow through a distal opening 914 in the distal end face 912.

[0105] According to some embodiments, the piston 926 comprises a body 930 and a cap 932. According to some embodiments, at least a portion of the body 930 of the piston 926 is configured to fit within a lumen (e.g., a service lumen, e.g., individual lumen 916c). According to some embodiments, the piston 926 is preferably disposed within the individual lumen 916c to minimize risk of infection, blockage, bacterial accumulation, and the like. According to some embodiments, the cap 932 includes, but is not limited to, an angular structure, such as a pyramidal, cone-shaped, etc., configured to seal off the distal end surface 912 of the PICC 900. According to some embodiments, the cap 932 extends at least partially from the distal end surface 912 in the closed configuration 918. According to some embodiments, actuation of the piston 926 is advantageously independent of the flushing pressure within the individual lumen 916c.

[0106] According to some embodiments, the piston 926 is at least partially disposed within a respective lumen 916c in each of the open configuration 920 and / or closed configuration 918. According to some embodiments, the piston 926 advantageously provides operational security (e.g., by minimizing inadvertent pushing / pulling or otherwise movement) of each of the open and closed configurations 920 and 918. Reference is now made to Figure 10, which illustrates a flow chart of a method for flushing a PICC (such as PICCs 300, 400 and 500) according to some embodiments.

[0107] At step 1000, the method includes inserting a distal portion of a PICC into a blood vessel. According to some embodiments, a healthcare provider inserts the distal portion (such as distal portion 310, 410, 510, 610, 710, 810 or 910 of PICC 300, 400, 500, 600, 700, 800 or 900) into a blood vessel and / or organ of a subject. Optionally, the insertion may be performed using a guidewire, e.g., a Nitinol guidewire, and / or using an imaging device such as an X-ray to confirm proper location of the PICC within the subject.

[0108] In step 1002, the method includes shifting a valve to a closed configuration. According to some embodiments, a valve located at a distal portion of the PICC is shifted to a closed configuration. According to some embodiments, the valve may include, but is not limited to, an inflatable balloon that, when inflated, seals off the distal portion of the PICC. The valve shifting mechanism may be controlled manually, for example, by a healthcare provider and / or subject, or mechanically, by actuating a valve at a proximal end, and / or automatically, for example, by sensor control.

[0109] At step 1004, the method includes injecting a flushing fluid through a proximal opening of the PICC. According to some embodiments, the flushing fluid, such as saline, may be introduced into the catheter through the proximal opening.

[0110] In step 1006, the method includes circulating and draining the flushing fluid outside the blood vessel. According to some embodiments, the flushing fluid continues to flow until it reaches the distal portion of the PICC. Once the closed valve configuration is reached, the flow direction of the flushing fluid changes, i.e., it circulates, and the flushing fluid enters a different lumen, allowing the flushing fluid to flow from the distal portion to the proximal portion of the catheter and out of the body. In some embodiments, the flushing fluid may be circulated and enter the same lumen.

[0111] In step 1008, the method includes analyzing the flushing fluid as it flows out. According to some embodiments, the flushing fluid may be collected upon flow and optionally further analyzed for the presence of any chemical and / or biological material, such as, for example, contaminants, sediments, bacteria, etc. According to some embodiments, the presence of chemical and / or biological material may be indicative of complications and / or infection. According to some embodiments, analysis of the flushing fluid allows for the identification of blood clots and / or bacteria. According to some embodiments, the presence of bacteria may be indicated to aid medical staff in providing appropriate treatment to the subject, thereby improving the subject's health and wellness.

[0112] According to some embodiments, the method may include analyzing one or more parameters related to the pressure of the flushing fluid leaving and / or entering the catheter to assess the quality of the catheter and / or flushing fluid performance. The method may also assist in measuring the amount of medical substance administered. In some embodiments, exceeding the maximum pressure allowed inside the PICC may result in the formation of various defects such as kinks, which may reduce the integrity of the PICC. According to some embodiments, pressure changes inside the PICC may indicate the presence of precipitates and / or the accumulation of residue. The accumulation of undesirable substances inside the PICC and occlusion of the PICC may eventually lead to blockage of the PICC. According to some embodiments, the method may include monitoring the pressure of the medical substance and / or flushing fluid using one or more sensors. The one or more sensors may be located at various locations across the length of the PICC, for example at the distal and / or proximal ends. According to some embodiments, the one or more sensors may be associated with one or more lumens. According to some embodiments, the one or more sensors may be configured to monitor the pressure of the medical substance and / or flushing fluid within the one or more lumens. In some embodiments, it is preferable to position the one or more sensors such that smooth inner and / or outer surfaces of the lumens and / or PICC are maintained, thereby reducing the risk of infection.

[0113] According to some embodiments, the method may include monitoring the flow volume of medical material entering the blood vessel with one or more sensors, According to some embodiments, changes in flow may indicate malfunction of the PICC, and may optionally require replacement of the PICC.

[0114] According to some embodiments, the method may include monitoring a flow rate of flushing fluid into and / or out of the catheter with one or more sensors. According to some embodiments, a change in the flow rate of flushing fluid may indicate a malfunction and / or replacement of a valve. According to some embodiments, valve replacement may be performed through a service conduit.

[0115] According to some embodiments, the method may include regulating, with the controller, the pressure and / or flow volume of the flushing fluid and / or medical substance, thereby facilitating maintaining the pressure and / or flow volume within an optimal range to improve suitability of the PICC.

[0116] In the description and claims of this application, the words "include" and "have" and forms thereof are not limited to the members in a list with which the words may be associated.

[0117] Unless otherwise defined, all technical and scientific terms used herein have the same meaning as commonly understood by those skilled in the art to which this disclosure pertains. In case of conflict, the patent specification, including definitions, shall prevail. As used herein, the indefinite articles "a" and "an" mean "at least one" or "one or more," unless the context clearly dictates otherwise.

[0118] It is understood that certain features of the disclosure that are described, for clarity, in the context of separate embodiments may also be provided in combination in a single embodiment. Conversely, for brevity, various features of the disclosure that are described in the context of a single embodiment may also be provided separately, or in any suitable combination or as appropriate, in any other described embodiment of the disclosure. A feature described in the context of an embodiment should not be considered an essential feature of that embodiment unless expressly specified as such.

[0119] Although steps of the methods according to some embodiments may be described in a particular order, the methods of the present disclosure may include some or all of the described steps performed in a different order. The methods of the present disclosure may include some of the described steps or all of the described steps. No particular step in a disclosed method is considered to be an essential step of the method unless expressly stated as such.

[0120] Although the present disclosure is described in relation to its specific embodiment, it is apparent that there may be numerous alternatives, modifications, and variations that are apparent to those skilled in the art. Accordingly, the present disclosure encompasses all such alternatives, modifications, and variations that are within the scope of the appended claims. It is to be understood that the present disclosure is not necessarily limited in its application to the details of the construction and arrangement of the parts and / or methods described herein. Other embodiments may be implemented and the embodiments may be carried out in various ways.

[0121] The phraseology and terminology used herein is for the purpose of description and should not be regarded as limiting. A citation or identification of a citation in this application should not be construed as an admission that such citation is available as prior art to the disclosure. Section headings are used herein to facilitate understanding of the specification and should not be construed as necessarily limiting.

Claims

1. a distal portion configured for insertion into a blood vessel and including a distal end opening; a proximal portion including a proximal opening; at least one flushing lumen extending therebetween; and a valve disposed within the at least one flushing lumen, the valve having two configurations: an open configuration that allows fluid flow through the distal end opening, and a closed configuration that blocks fluid flow through the distal end opening.

1. A peripherally insertable central catheter (PICC) comprising: A peripherally insertable central catheter, wherein in the closed configuration of the valve, flushing fluid introduced into the catheter through the proximal opening circulates back and flows out of the subject's blood vessel through the proximal portion, thereby preventing the flushing fluid from exiting through the distal end opening.

2. The catheter of claim 1 , wherein the at least one flushing lumen is further configured to deliver a medical substance to the subject in the open configuration of the valve.

3. 10. The catheter of claim 1, wherein the at least one flushing lumen is divided into two separate lumens, a first lumen and a second lumen, the first lumen configured to deliver flushing fluid and the second lumen configured to collect the flushing fluid, direct it to a proximal portion, and drain it from the subject's blood vessel.

4. The catheter of claim 1 , wherein the valve comprises an expandable element configured to expand to a size sufficient to seal the distal end face opening.

5. The catheter of claim 4 , further comprising an inflation conduit in fluid flow communication with the expandable element.

6. The catheter of claim 1 , wherein the valve includes a sealing flap and / or shutter configured to controllably seal the distal end face opening.

7. The device of any preceding claim, wherein the valve comprises a guidewire valve configured to controllably seal the distal end face opening.

8. The device of any preceding claim, wherein the valve comprises a piston configured to controllably seal the distal end opening.

9. The catheter of claim 1 , wherein the valve comprises a duckbill valve configured to controllably seal the distal end face opening.

10. The catheter of claim 1 , wherein the valve comprises a skirt valve configured to controllably seal the distal end face opening.

11. The catheter of any one of claims 1 to 6, further comprising an additional separate lumen for delivering a medical substance to the subject in the open configuration of the valve.

12. The catheter of any one of claims 1 to 6, wherein the flushing fluid circulated back through the proximal portion exits the catheter through the proximal opening.

13. The catheter of any one of claims 1 to 6, wherein the flushing fluid circulated back through the proximal portion exits the catheter through the proximal exhaust port.

14. 7. The catheter of claim 1, further comprising a pressure adjustment mechanism configured to regulate the flow rate of the flushing fluid to facilitate circulation of the flushing fluid through the at least one flushing lumen, back through the proximal portion, and out of the catheter.

15. 10. The catheter of claim 1, comprising a flushing lumen, a lumen for actuating the valve, a lumen for delivering a medical substance, and a lumen comprising a duckbill valve for facilitating separation of the medical substance.

16. The catheter of any one of claims 1 to 6, further comprising one or more sensors for monitoring and / or adjusting the pressure of the flushing liquid to facilitate pressure regulation.

17. A catheter according to any one of claims 1 to 6, further comprising one or more sensors for monitoring and / or regulating the flow rate of the flushing fluid into and / or out of the catheter.

18. The catheter of any one of claims 1 to 6, further comprising one or more sensors for monitoring and / or regulating the flow rate of the medical substance entering the blood vessel.

19. 1. A method of flushing a peripherally insertable central catheter (PICC), comprising: a distal portion including a distal end opening; a proximal portion including a proximal opening; at least one flushing lumen extending therebetween; and a valve disposed within the at least one flushing lumen; providing a PICC comprising: inserting the distal portion of the PICC into a blood vessel of a subject; shifting the valve to a closed configuration to block fluid flow through the distal end opening; injecting a flushing fluid into the catheter through the proximal opening; The flushing method, wherein the flushing fluid returns through the proximal portion and circulates out of the catheter, preventing the flushing fluid from entering the subject's blood vessel through the distal end opening.

20. 20. The method of claim 19, further comprising analyzing the flushing fluid for chemical and / or biological substances indicative of complications and / or infection.

21. 20. The method of claim 19, wherein the step of analyzing the flushing fluid includes identifying blood clots and / or bacteria.

22. 20. The method of claim 19, further comprising analyzing one or more parameters related to the pressure of the flushing fluid exiting and / or entering the catheter to evaluate the performance of the catheter and / or the flushing fluid.

23. 20. The method of claim 19, further comprising monitoring and / or regulating the pressure of the flushing liquid with one or more sensors.

24. 20. The method of claim 19, further comprising monitoring and / or regulating the flow rate of the flushing fluid into and / or out of the catheter using one or more sensors.

25. 20. The method of claim 19, further comprising monitoring and / or regulating the flow rate of the medical substance entering the blood vessel using one or more sensors.

26. The method of any one of claims 19 to 25, further comprising regulating the pressure and / or flow rate of the flushing fluid and / or the medical substance with a controller.

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