Therapeutic systems for medical treatment with magnetoresponsive materials or structures

Abstract

Therapeutic systems and methods for medical treatment use magnetoresponsive materials and structures. For example, a therapeutic system can include an elongate medical device and a magnetic-field generator. The elongate medical device can include a luminal coating, an abluminal coating, or both over at least a distal portion of the elongate medical device. Such a coating can include one or more magnetoresponsive submicron materials responsive to a magnetic field generated by the magnetic-field generator. When the magnetic field is directed toward the coating, the medical treatment can be administered. The medical treatment can be selected from local hypothermia, targeted delivery of one or more therapeutic agents, and combinations thereof for disrupting any thrombotic or non-thrombotic occlusions on the elongate medical device or another elongate medical device. Alternatives to the coating can include formation of the distal portion of the elongate medical device with a magnetoelastic material or magnetoresponsive structure thereon.

Description

THERAPEUTIC SYSTEMS AND METHODS FOR MEDICAL TREATMENT WITH MAGNETORESPONSIVE MATERIALS OR STRUCTURESPRIORITY

[0001] This application claims the benefit of priority to U.S. Provisional Application No. 63 / 599,331, filed November 15, 2023, which is incorporated by reference in its entirety into this application.BACKGROUND

[0002] Occlusions in catheters such as central venous catheters (“CVCs”) or peripherally inserted central catheters (“PICCs”) can inhibit or even prevent fluids from flowing through such catheters. This can lead to ineffective medication-based therapy as well as complications such as infiltration, phlebitis, or infection. The foregoing occlusions can arise in a variety of different ways. In an example, thrombotic occlusions can arise when one or more thrombi form within, around, or at a distal-end portion of a catheter as shown in FIG. 21. In another example, non-thrombotic occlusions can arise from biofilm formation during catheter- related bloodstream infections (“CRB Sis”), lipid residue from lipid-containing nutritional admixtures or drug formulations including oleaginous vehicles, or drug precipitation from the same or different drug formulations within, around, or at a distal-end portion of a catheter. Existing solutions for medical treatment of thrombotic or non-thrombotic occlusions include antithrombotic or antimicrobial catheter coatings, antithrombotic or antimicrobial catheter lock solutions, and application of ultrasonic mechanical vibrations; however, such existing solutions are limited in their efficacy, particularly when it comes to antimicrobial resistant bacteria.

[0003] In view of the foregoing, disclosed herein are therapeutic systems and methods for medical treatment of thrombotic and non-thrombotic occlusions using magnetoresponsive materials and structures.SUMMARY

[0004] Disclosed herein is a therapeutic system for medical treatment using one or more magnetoresponsive materials. The therapeutic system includes, in some embodiments, an elongate medical device and a magnetic-field generator. The elongate medical device includes a primary lumen and a coating selected from a luminal coating, an abluminal coating, and a combination of both the luminal and abluminal coatings over at least a distal portion of theelongate medical device. The coating includes one or more magnetoresponsive submicron materials for the one-or-more magnetoresponsive materials. The one-or-more magnetoresponsive submicron materials are responsive to a magnetic field generated by the magnetic-field generator when the magnetic field is directed toward the coating. Indeed, when the magnetic field is directed toward the coating, the medical treatment is administered, which medical treatment is selected from local hypothermia, targeted delivery of one or more therapeutic agents, and combinations thereof for disrupting any thrombotic or non-thrombotic occlusions.

[0005] In some embodiments, the therapeutic system further includes a console configured to drive the magnetic-field generator. The console includes one or more processors and memory having instructions stored thereon that drive the magnetic field generator when the instructions are executed by the one-or-more processors.

[0006] In some embodiments, the console and the magnetic-field generator form a dedicated magnetic field-generating system of the therapeutic system.

[0007] In some embodiments, the console is an ultrasound console configured for both ultrasound imaging and driving the magnetic-field generator. The magnetic-field generator is integrated into an ultrasound probe.

[0008] In some embodiments, the elongate medical device is an intravenous catheter. The distal portion of the elongate medical device includes a distal tip such that the coating extends over the distal tip for disrupting the thrombotic or non-thrombotic occlusions thereof, if present.

[0009] In some embodiments, the elongate medical device is a dedicated companion implement to the magnetic-field generator of the therapeutic system. The companion implement is configured for insertion into one or more lumens of an intravenous catheter.

[0010] In some embodiments, the distal portion of the elongate medical device includes a distal tip such that the coating extends over the distal tip for contacting and disrupting the thrombotic or non-thrombotic occlusions in the one-or-more lumens of the intravenous catheter, if present.

[0011] In some embodiments, the distal portion of the elongate medical device including the coating is inflatable for the contacting and disrupting of the thrombotic or non- thrombotic occlusions in the one-or-more lumens of the intravenous catheter, if present. The primary lumen is configured as an inflation lumen for inflating the distal portion of the elongate medical device.

[0012] In some embodiments, the companion instrument is steerable for the contacting and disrupting of the thrombotic or non-thrombotic occlusions in the one-or-more lumens of the intravenous catheter, if present. The primary lumen includes a steering element disposed therein for steering the companion implement.

[0013] In some embodiments, the coating includes the one-or-more magnetoresponsive submicron materials deposited on at least the distal portion of the elongate medical device.

[0014] In some embodiments, the coating includes the one-or-more magnetoresponsive submicron materials embedded in a coating material on at least the distal portion of the elongate medical device.

[0015] In some embodiments, the coating includes the one-or-more magnetoresponsive submicron materials and the one-or-more therapeutic agents deposited on at least the distal portion of the elongate medical device or embedded in a coating material on at least the distal portion of the elongate medical device.

[0016] In some embodiments, the magnetic field generated by the magnetic-field generator causes the one-or-more magnetoresponsive submicron materials to resonate therewith. Subsequent energy loss of the one-or-more magnetoresponsive submicron materials through relaxation of the one-or-more magnetoresponsive submicron materials causes lattice vibrations and, thus, local hypothermia in at least the distal portion of the elongate medical device for disrupting the thrombotic or non-thrombotic occlusions, if present.

[0017] In some embodiments, the magnetic field generated by the magnetic-field generator causes the one-or-more magnetoresponsive submicron materials to resonate therewith and, thus, release the one-or-more therapeutic agents from at least the distal portion of the elongate medical device for disrupting the thrombotic or non-thrombotic occlusions, if present.

[0018] In some embodiments, each occlusion of the thrombotic or non-thrombotic occlusions is selected from an intraluminal thrombus, a fibrin tail, a fibrin sheath, a mural thrombus, a biofilm, a lipid residue, a precipitated drug, and some combination thereof.

[0019] Also disclosed herein is a therapeutic system for medical treatment using one or more magnetoresponsive structures. The therapeutic system includes, in some embodiments, an elongate medical device and a magnetic-field generator. The elongate medical device includes a primary lumen and a plurality of magnetoresponsive structures incorporated into a luminal surface, an abluminal surface, or a combination of both the luminal and abluminal surfaces over at least a distal portion of the elongate medical device. The one-or-more magnetoresponsive structures are responsive to a magnetic field generated by the magnetic- field generator when the magnetic field is directed toward the distal portion of the elongate medical device. Indeed, when the magnetic field is directed toward the distal portion of the elongate medical device the medical treatment is administered, which medical treatment includes actuating the plurality of magnetoresponsive structures to disrupt any thrombotic or non-thrombotic occlusions.

[0020] In some embodiments, the therapeutic system further includes a console configured to drive the magnetic-field generator. The console includes one or more processors and memory having instructions stored thereon that drive the magnetic field generator when the instructions are executed by the one-or-more processors.

[0021] In some embodiments, the console and the magnetic-field generator form a dedicated magnetic field-generating system of the therapeutic system.

[0022] In some embodiments, the console is an ultrasound console configured for both ultrasound imaging and driving the magnetic-field generator. The magnetic-field generator is integrated into an ultrasound probe.

[0023] In some embodiments, the elongate medical device is an intravenous catheter. The plurality of magnetoresponsive structures are incorporated into the distal portion of the elongate medical device including a distal tip of the intravenous catheter for disrupting the thrombotic or non-thrombotic occlusions thereof, if present.

[0024] In some embodiments, each occlusion of the thrombotic or non-thrombotic occlusions is selected from an intraluminal thrombus, a fibrin tail, a fibrin sheath, a mural thrombus, a biofilm, a lipid residue, a precipitated drug, and some combination thereof.

[0025] Also disclosed herein is a therapeutic system for medical treatment using a magnetoelastic material. The therapeutic system includes, in some embodiments, an elongate medical device and a magnetic-field generator. The elongate medical device includes a primary lumen and at least a distal portion formed of the magnetoelastic material or incorporating the magnetoelastic material therein. The magnetoelastic material is responsive to a magnetic field generated by the magnetic-field generator when the magnetic field is directed toward the distal portion of the elongate medical device. Indeed, when the magnetic field is directed toward the distal portion of the elongate medical device the medical treatment is administered, which medical treatment includes actuating the magnetoelastic material to disrupt any thrombotic or non-thrombotic occlusions.

[0026] In some embodiments, the therapeutic system further includes a console configured to drive the magnetic-field generator. The console includes one or more processors and memory having instructions stored thereon that drive the magnetic field generator when the instructions are executed by the one-or-more processors.

[0027] In some embodiments, the console and the magnetic-field generator form a dedicated magnetic field-generating system of the therapeutic system.

[0028] In some embodiments, the console is an ultrasound console configured for both ultrasound imaging and driving the magnetic-field generator. The magnetic-field generator is integrated into an ultrasound probe.

[0029] In some embodiments, the elongate medical device is an intravenous catheter. The magnetoelastic material is incorporated into the distal portion of the elongate medical device including a distal tip of the intravenous catheter for disrupting the thrombotic or non- thrombotic occlusions thereof, if present.

[0030] In some embodiments, each occlusion of the thrombotic or non-thrombotic occlusions is selected from an intraluminal thrombus, a fibrin tail, a fibrin sheath, a mural thrombus, a biofilm, a lipid residue, a precipitated drug, and some combination thereof.

[0031] Also disclosed herein is a method of a therapeutic system for medical treatment. The method includes, in some embodiments, a magnetic field-generating operation, a magnetic field-responding operation, and an occlusion-disrupting operation. The magnetic fieldgenerating operation includes generating a magnetic field with a magnetic-field generator. The magnetic field-responding operation includes responding to the magnetic field by a distal portion of an elongate medical device to effectuate the medical treatment. At least the distal portion of the elongate medical device includes a coating over the distal portion of the elongate medical device. Such a coating includes one or more magnetoresponsive submicron materials for responding to the magnetic field. Alternatively, at least the distal portion of the elongate medical device includes a plurality of magnetoresponsive structures incorporated into a surface of the distal portion of the elongate medical device for responding to the magnetic field. Further alternatively, at least the distal portion of the elongate medical device includes a magnetoelastic material incorporated into the distal portion of the elongate medical device or forming an entirety of the distal portion of the elongate medical device for responding to the magnetic field. The occlusion-disrupting operation includes disrupting any thrombotic or non-thrombotic occlusions, if present, on the distal portion of elongate medical device upon responding to the magnetic field.

[0032] In some embodiments, the method further includes a magnetic field-driving operation. The magnetic field-driving operation includes driving the magnetic-field generator with a console including one or more processors as well as memory having instructions stored thereon for the driving of the magnetic-field generator when the instructions are executed by the one-or-more processors.

[0033] These and other features of the concepts provided herein will become more apparent to those of skill in the art in view of the accompanying drawings and following description, which describe particular embodiments of such concepts in greater detail.BRIEF DESCRIPTION OF DRAWINGS

[0034] FIG. 1 illustrates a therapeutic system for medical treatment using one or more magnetoresponsive materials or structures in accordance with some embodiments.

[0035] FIG. 2A illustrates an elongate medical device in accordance with some embodiments.

[0036] FIG. 2B illustrates a transverse cross section of a distal portion of the elongate medical device including magnetoresponsive materials disposed therein in accordance with some embodiments.

[0037] FIG. 3 illustrates a transverse cross section of the distal portion of the elongate medical device including a coating of magnetoresponsive materials in accordance with some embodiments.

[0038] FIG. 4 illustrates a transverse cross section of the distal portion of the elongate medical device including another coating having magnetoresponsive materials disposed therein in accordance with some embodiments.

[0039] FIG. 5 illustrates a transverse cross section of the distal portion of the elongate medical device including yet another coating of magnetoresponsive materials having one or more therapeutic agents disposed therein in accordance with some embodiments.

[0040] FIG. 6 illustrates a transverse cross section of the distal portion of the elongate medical device including yet another coating having magnetoresponsive materials and the one- or-more therapeutic agents disposed therein in accordance with some embodiments.

[0041] FIG. 7 illustrates a console and a magnetic-field generator forming a dedicated magnetic field-generating system of the therapeutic system in accordance with some embodiments.

[0042] FIG. 8 illustrates an ultrasound console and an ultrasound probe including a magnetic field-generating subsystem as part of the therapeutic system in accordance with some embodiments.

[0043] FIG. 9 illustrates a block diagram of the ultrasound console and the ultrasound probe in accordance with some embodiments.

[0044] FIG. 10 illustrates the magnetic-field generator in use on a CVC as the elongate medical device in accordance with some embodiments, the CVC having a thrombotic or non- thrombotic occlusion.

[0045] FIG. 11 illustrates a detailed view of the magnetic-field generator in use on the CVC having the thrombotic or non-thrombotic occlusion in accordance with some embodiments.

[0046] FIG. 12 illustrates a first mechanism for disrupting thrombotic or non- thrombotic occlusions in accordance with some embodiments in accordance with some embodiments.

[0047] FIG. 13 illustrates a second mechanism for disrupting the thrombotic or non- thrombotic occlusions in accordance with some embodiments in accordance with some embodiments.

[0048] FIG. 14 illustrates the magnetic-field generator in use on a CVC or PICC with a companion implement as the elongate medical device disposed therein in accordance with some embodiments, the CVC or PICC having a thrombotic or non-thrombotic occlusion.

[0049] FIG. 15 illustrates a detailed view the companion implement disposed in the CVC or PICC, the companion implement including an inflatable distal portion inflated to be in contact with the thrombotic or non-thrombotic occlusion in accordance with some embodiments.

[0050] FIG. 16 illustrates a detailed view the companion implement disposed in the CVC or PICC, the companion implement including a steerable distal portion steered to be in contact with the thrombotic or non-thrombotic occlusion in accordance with some embodiments.

[0051] FIG. 17 illustrates a detailed view of the distal portion of the elongate medical device including a plurality of magnetoresponsive structures incorporated into an abluminal surface of the elongate medical device in accordance with some embodiments.

[0052] FIG. 18 illustrates a detailed view of a cantilever for a magnetoresponsive structure of the plurality of magnetoresponsive structures in accordance with some embodiments.

[0053] FIG. 19 illustrates a detailed view of the distal portion of the elongate medical device including another plurality of magnetoresponsive structures incorporated into the abluminal surface of the elongate medical device in accordance with some embodiments.

[0054] FIG. 20 illustrates a detailed view of a pillar for a magnetoresponsive structure of the plurality of magnetoresponsive structures in accordance with some embodiments.

[0055] FIG. 21 illustrates a variety of thrombotic occlusions medically treatable by way of the therapeutic systems and methods for medical treatment in accordance with some embodiments.DESCRIPTION

[0056] Before some particular embodiments are disclosed in greater detail, it should be understood that the particular embodiments disclosed herein do not limit the scope of the concepts provided herein. It should also be understood that a particular embodiment disclosed herein can have features that can be readily separated from the particular embodiment and optionally combined with or substituted for features of any of a number of other embodiments disclosed herein.

[0057] Regarding terms used herein, it should also be understood the terms are for the purpose of describing some particular embodiments, and the terms do not limit the scope of the concepts provided herein. Ordinal numbers (e.g., first, second, third, etc.) are generally used to distinguish or identify different features or steps in a group of features or steps, and do not supply a serial or numerical limitation. For example, “first,” “second,” and “third” features or steps need not necessarily appear in that order, and the particular embodiments including such features or steps need not necessarily be limited to the three features or steps. In addition, any of the foregoing features or steps can, in turn, further include one or more features or steps unless indicated otherwise. Labels such as “left,” “right,” “top,” “bottom,” “front,” “back,” and the like are used for convenience and are not intended to imply, for example, any particular fixed location, orientation, or direction. Instead, such labels are used to reflect, for example, relative location, orientation, or directions. Singular forms of “a,” “an,” and “the” include plural references unless the context clearly dictates otherwise.

[0058] “Proximal” is used to indicate a portion, section, piece, element, or the like of a medical device intended to be near or relatively nearer to a clinician when the medical device is used on a patient. For example, a “proximal portion” or “proximal section” of the medical device includes a portion or section of the medical device intended to be near the clinician when the medical device is used on the patient. Likewise, a “proximal length” of the medical device includes a length of the medical device intended to be near the clinician when themedical device is used on the patient. A “proximal end” of the medical device is an end of the medical device intended to be near the clinician when the medical device is used on the patient. The proximal portion, the proximal section, or the proximal length of the medical device need not include the proximal end of the medical device. Indeed, the proximal portion, the proximal section, or the proximal length of the medical device can be short of the proximal end of the medical device. However, the proximal portion, the proximal section, or the proximal length of the medical device can include the proximal end of the medical device. Should context not suggest the proximal portion, the proximal section, or the proximal length of the medical device includes the proximal end of the medical device, or if it is deemed expedient in the following description, “proximal portion,” “proximal section,” or “proximal length” can be modified to indicate such a portion, section, or length includes an end portion, an end section, or an end length of the medical device for a “proximal end portion,” a “proximal end section,” or a “proximal end length” of the medical device, respectively.

[0059] “Distal” is used to indicate a portion, section, piece, element, or the like of a medical device intended to be near, relatively nearer, or even in a patient when the medical device is used on the patient. For example, a “distal portion” or “distal section” of the medical device includes a portion or section of the medical device intended to be near, relatively nearer, or even in the patient when the medical device is used on the patient. Likewise, a “distal length” of the medical device includes a length of the medical device intended to be near, relatively nearer, or even in the patient when the medical device is used on the patient. A “distal end” of the medical device is an end of the medical device intended to be near, relatively nearer, or even in the patient when the medical device is used on the patient. The distal portion, the distal section, or the distal length of the medical device need not include the distal end of the medical device. Indeed, the distal portion, the distal section, or the distal length of the medical device can be short of the distal end of the medical device. However, the distal portion, the distal section, or the distal length of the medical device can include the distal end of the medical device. Should context not suggest the distal portion, the distal section, or the distal length of the medical device includes the distal end of the medical device, or if it is deemed expedient in the following description, “distal portion,” “distal section,” or “distal length” can be modified to indicate such a portion, section, or length includes an end portion, an end section, or an end length of the medical device for a “distal end portion,” a “distal end section,” or a “distal end length” of the medical device, respectively.

[0060] Unless defined otherwise, all technical and scientific terms used herein have the same meaning as commonly understood by those of ordinary skill in the art.

[0061] As set forth above, occlusions in catheters such as CVCs or PICCs can inhibit or even prevent fluids from flowing through such catheters. This can lead to ineffective medication-based therapy as well as complications such as infiltration, phlebitis, or infection. The foregoing occlusions can arise in a variety of different ways. In an example, thrombotic occlusions can arise when one or more thrombi form within, around, or at a distal-end portion of a catheter as shown in FIG. 21. In another example, non-thrombotic occlusions can arise from biofilm formation during CRB Sis, lipid residue from lipid-containing nutritional admixtures or drug formulations including oleaginous vehicles, or drug precipitation from the same or different drug formulations within, around, or at a distal-end portion of a catheter. Existing solutions for medical treatment of thrombotic or non-thrombotic occlusions include antithrombotic or antimicrobial catheter coatings, antithrombotic or antimicrobial catheter lock solutions, and application of ultrasonic mechanical vibrations; however, such existing solutions are limited in their efficacy, particularly when it comes to antimicrobial resistant bacteria.

[0062] In view of the foregoing, disclosed herein are therapeutic systems and methods for medical treatment of thrombotic and non-thrombotic occlusions using magnetoresponsive materials and structures. Indeed, the therapeutic systems and methods disclosed herein provide medical treatment for thrombotic and non-thrombotic occlusions selected from at least intraluminal thrombi, fibrin tails, fibrin sheaths, mural thrombi, biofilms, lipid residues, precipitated drugs, and various combinations thereof, whether the thrombotic occlusions, the non-thrombotic occlusions, or the various combinations thereof are minimal deposits, complete blockages, or something therebetween. For example, as shown in FIG. 21, the therapeutic systems and methods can provide medical treatment for at least an intraluminal thrombus 206, a fibrin tail 208, a fibrin sheath 210, or mural thrombus 212 in the catheter tube 114 of the intravenous catheter 112 or another CVC or PICC while the foregoing catheter is disposed in a blood vessel 214 of a patient.Therapeutic systems

[0063] FIG. 1 illustrates a therapeutic system 100 for medical treatment using one or more magnetoresponsive materials 102 or structures 104 in accordance with some embodiments.

[0064] As shown, the therapeutic system 100 for medical treatment includes an elongate medical device 106 and a magnetic-field generator 108, each of which can vary in accordance with different embodiments. Indeed, as set forth below, the elongate medical device 106 can be the intravenous catheter 112 shown, for example, in FIG. 2 A, or some other tubular medical device including a stent, a urinary catheter such a Foley catheter, or the like. Alternatively, the elongate medical device 106 can be the companion implement 124 shown, for example, in FIG. 14, wherein the companion implement 124 is configured for insertion into one or more lumens of the intravenous catheter 112 or another intravenous catheter. The one- or-more magnetoresponsive materials 102 or structures 104 of the elongate medical device 106 can also vary in accordance with different embodiments. As further set forth below, the magnetic-field generator 108 and a console 110 such as the dedicated console 154 can form the dedicated magnetic field-generating system 156 of the therapeutic system 100 in some embodiments. However, in some other embodiments, the magnetic-field generator 108 is integrated into the ultrasound probe 160 and the console 110 can be the ultrasound console 158 configured for both ultrasound imaging and driving the magnetic-field generator 108. In such embodiments, the magnetic field-generating subsystem of the ultrasound system 162 can be considered part of the therapeutic system 100.Elongate medical devices

[0065] FIGS. 2A, 10, and 11 illustrate the elongate medical device 106 in accordance with some embodiments.

[0066] The elongate medical device 106 can be an intravenous catheter 112 including a catheter tube 114, a catheter hub 116, one or more extension legs 118, and one or more extension-leg fittings 120 fluidly connected in the foregoing order. While the intravenous catheter 112 of FIG. 2 A includes an unfurcated or nonfurcated catheter hub, a single corresponding extension leg, and a single corresponding extension-leg fitting, the intravenous catheter 112 is not limited thereto. Indeed, the intravenous catheter 112 can be multiluminal with the catheter tube 114 including a plurality of catheter-tube lumens such as two or three catheter-tube lumens. The catheter hub 116 can be correspondingly furcated with a plurality of catheter-hub lumens such as two or three catheter-hub lumens in a bifurcated or trifurcated catheter hub, respectively. The one-or-more extension legs 118 can be a plurality of extension legs in accordance with the catheter hub 116 and any furcation thereof. For example, the plurality of extension legs 118 can be a pair or trio of extension legs, wherein each extensionleg of the plurality of extension legs 118 has an extension-leg lumen. Lastly, the one-or-more extension-leg fittings 120 can be a plurality of extension-leg fittings in accordance with the plurality of extension legs 118. Accordingly, the plurality of extension-leg fittings 120 can be a pair or trio of extension-leg fitting in some embodiments.

[0067] Whether the intravenous catheter 112 has a single lumen resulting from fluid connection of a single catheter-tube lumen, a single catheter-hub lumen, and a single extensionleg lumen or a plurality of lumens resulting from fluid connection of the plurality of cathetertube lumens, the plurality of catheter-hub lumens, and a plurality of extension-leg lumens, respectively, the intravenous catheter 112 has at least a primary lumen 122 therethrough. Such a primary lumen 122 is characterized by extending from a distal portion of the intravenous catheter 112 such as a distal end of the intravenous catheter 112 to a proximal portion of the intravenous catheter 112 such as a proximal end of the intravenous catheter 112. Other lumens of the intravenous catheter 112 such as a secondary lumen or a tertiary lumen of the intravenous catheter 112 can be short of the distal end of the intravenous catheter 112 but, like the primary lumen 122, extend to the proximal portion of the intravenous catheter 112 such as the proximal end of the intravenous catheter 112.

[0068] FIGS. 14-16 illustrates the elongate medical device 106 in accordance with some other embodiments.

[0069] In an alternative to the elongate medical device 106 being the intravenous catheter 112, the elongate medical device 106 can be a dedicated companion implement 124 to the magnetic-field generator 108 of the therapeutic system 100, wherein the companion implement 124 includes an elongate body 125 configured for insertion into one or more lumens of an intravenous catheter similar to the intravenous catheter 112, albeit without the one-or- more magnetoresponsive materials 102 or structures 104 of the intravenous catheter 112. For example, the companion implement 124 can be sized for insertion into a primary or distal lumen of an intravenous catheter such as a CVC or PICC as shown in each figure of FIGS. 14-16. Further, at least an end portion of a distal portion of the companion implement 124 can be configured as an inflatable portion 126 or a steerable portion 128 of the companion implement 124 for contacting an exposed side of any thrombotic or non-thrombotic occlusion in the one- or-more lumens of the intravenous catheter 112. Indeed, as shown in FIG. 15, the inflatable portion 126 of the companion implement 124 can be inflated into contact with the exposed side of any thrombotic or non-thrombotic occlusion in the one-or-more lumens of the intravenouscatheter for disrupting the thrombotic or non-thrombotic occlusion in accordance with medical treatment thereof. As shown in FIG 16, the steerable portion 128 of the companion implement 124 can be steered into contact with the exposed side of any thrombotic or non-thrombotic occlusion in the one-or-more lumens of the intravenous catheter for disrupting the thrombotic or non-thrombotic occlusion in accordance with the medical treatment thereof.

[0070] It should be understood that while the companion implement 124 is intended for the medical treatment of thrombotic or non-thrombotic occlusions in an intravenous catheter similar to the intravenous catheter 112 but without the one-or-more magnetoresponsive materials 102 or structures 104 thereof, the companion implement 124 can be used together with the intravenous catheter 112 to enhance the medical treatment of any thrombotic or non- thrombotic occlusions. Indeed, the distal portion of the companion implement 124 can be used to contact the exposed side of any thrombotic or non-thrombotic occlusion in one or more lumens of the intravenous catheter 112 while the distal portion of the intravenous catheter 112 is already in contact with an underside of the thrombotic or non-thrombotic occlusion. When a magnetic field generated by the magnetic-field generator 108 is directed toward the distal portion of both the companion implement 124 and the intravenous catheter 112, the thrombotic or non-thrombotic occlusion can be disrupted from both the exposed side and the underside for enhanced medical treatment of the thrombotic or non-thrombotic occlusion.

[0071] Like the intravenous catheter 112, the companion implement 124 has at least the primary lumen 122 therethrough. Such a primary lumen 122 is characterized by extending from the distal portion of the companion implement 124 to a proximal portion of the companion implement 124 such as a proximal end of the companion implement 124. Different than the intravenous catheter 112, however, the primary lumen 122 of the companion implement 124 is not for medication-based therapy or the like but for inflating the inflatable portion 126 or steering the steerable portion 128 of the companion implement 124. In an example, the primary lumen 122 of the companion implement 124 can be configured as an inflation lumen for inflating the inflatable portion 126 of the companion implement 124 in the distal portion thereof as shown in FIG. 15. In another example, the primary lumen 122 of the companion implement 124 can be configured with a steering element (e.g., one or more steering wires) disposed therein for steering the steerable portion 128 of the companion implement 124 in the distal portion thereof as shown in FIG. 16.

[0072] Whether the elongate medical device 106 is the intravenous catheter 112 or the companion implement 124, at least a distal portion of the elongate medical device 106 includes the one-or-more magnetoresponsive materials 102 or structures 104. Like that set forth above, such a distal portion of the elongate medical device 106 can include a distal end portion of the elongate medical device 106 such as a distal tip of the elongate medical device 106, which distal end portion of the elongate medical device 106 includes a distal end of the elongate medical device 106. Being as the distal portion of the elongate medical device 106 can include the one-or-more magnetoresponsive materials 102 or structures 104, the distal end portion of the elongate medical device 106 can include the one-or-more magnetoresponsive materials 102 or structures 104. In an example, the distal end portion of the intravenous catheter 112 can be commensurate with a distal tip (e.g., a tapered portion of a same or different material as a remainder of the catheter tube) of the intravenous catheter 112, wherein at least the distal tip of the intravenous catheter 112 includes the one-or-more magnetoresponsive materials 102 or structures 104 as shown among FIGS. 2A, 2B, and 3-6. In another example, the distal end portion of the companion implement 124 can be commensurate with the inflatable or steerable portion 126 or 128 of the companion implement 124, wherein at least the inflatable or steerable portion 126 or 128 of the companion implement 124 includes the one-or-more magnetoresponsive materials 102 or structures 104 as shown among FIGS. 2A, 2B, 3-6, and 14-16.

[0073] As to the one-or-more magnetoresponsive materials 102, at least the distal portion of the elongate medical device 106 such as the distal end portion of the elongate medical device 106 (e.g., the distal tip of the intravenous catheter 112, the inflatable portion 126 of the companion implement 124, the steerable portion 128 of the companion implement 124) can be formed of the one-or-more magnetoresponsive materials 102, incorporate the one-or-more magnetoresponsive materials 102 therein, include a coating 130 of the one-or-more magnetoresponsive materials 102, or some combination thereof for administering the medical treatment. That said, up to an entirety of the elongate medical device 106 can be formed of the one-or-more magnetoresponsive materials 102, incorporate the one-or-more magnetoresponsive materials 102 therein, include the coating 130 of the one-or-more magnetoresponsive materials 102, or some combination thereof for administering the medical treatment.

[0074] Regarding at least the distal portion of the elongate medical device 106 being formed of the one-or-more magnetoresponsive materials 102 or incorporating the one-or-more magnetoresponsive materials 102 therein, at least the distal portion of the elongate medical device 106 or the distal end portion thereof can be formed of one or more magnetoelastic materials 132 or incorporate the one-or-more magnetoelastic materials 132 therein. For example, at least the distal portion of the elongate medical device 106 or the distal end portion thereof can incorporate the one-or-more magnetoelastic materials 132, wherein one such magnetoelastic material can include elongate strips of Fe4oNi38Mo4Bi8, longitudinally disposed or embedded in the foregoing portion of the elongate medical device 106 as shown by way of the transverse cross section of the distal portion of the elongate medical device 106 in FIG. 2B.

[0075] The one-or-more magnetoelastic materials 132 are responsive to the magnetic field generated by the magnetic-field generator 108 when the magnetic field is directed toward the portion (e.g., the distal portion, the distal end portion, or the distal end) of the elongate medical device 106 including the one-or-more magnetoelastic materials 132. Indeed, when the magnetic field is directed toward the portion of the elongate medical device 106 including the one-or-more magnetoelastic materials 132 for a sufficient period of time, the medical treatment is administered, which medical treatment includes actuating the one-or-more magnetoelastic materials 132 and, thereby, deforming them to disrupt any thrombotic or non-thrombotic occlusions present in the elongate medical device 106, for example, break up or dissolve the thrombotic occlusions or break up the non-thrombotic occlusions of bacterial biofilms.

[0076] Regarding at least the distal portion of the elongate medical device 106 including the coating 130 of the one-or-more magnetoresponsive materials 102, at least the distal portion of the elongate medical device 106 or the distal end portion thereof can include the coating 130 formed of one or more magnetoresponsive submicron materials 134, one or more magnetoresponsive micron-sized materials 136, or some combination thereof. Alternatively, the coating 130 can be formed of another coating material 138 such as a biocompatible polymer with the one-or-more magnetoresponsive submicron materials 134, the one-or-more magnetoresponsive micron-sized materials 136, or some combination thereof disposed or otherwise loaded in the coating 130 of the other coating material 138. Such a coating 130 can be further defined as a luminal coating 140, an abluminal coating 142, or a combination of the luminal and abluminal coatings 140 and 142 — even though FIGS. 3-6 only show the combination of the luminal and abluminal coatings 140 and 142. Unless there is anexpress reference to such a species of the coating 130, or should context suggest otherwise, the term “coating” should be understood as a genus encompassing each species of the luminal coating 140, the abluminal coating 142, and the combination of the luminal and abluminal coatings 140 and 142.

[0077] The one-or-more magnetoresponsive materials 102 of the coating 130 are responsive to the magnetic field generated by the magnetic-field generator 108 when the magnetic field is directed toward the portion (e.g., the distal portion, the distal end portion, or the distal end) of the elongate medical device 106 over which the coating 130 extends. Indeed, when the magnetic field is directed toward the coating 130 of the elongate medical device 106 including the one-or-more magnetoresponsive materials 102 for a sufficient period of time, the medical treatment is administered, which medical treatment is selected from local hypothermia, release of some of the one-or-more magnetoresponsive materials 102, targeted delivery of the one-or-more therapeutic agents 144, and combinations thereof for disrupting any thrombotic or non-thrombotic occlusions present in the elongate medical device 106, for example, breaking up or dissolving the thrombotic occlusions or killing and breaking up the non- thrombotic occlusions of bacterial biofilms.

[0078] Notably, the term “magnetoresponsive submicron materials” is used herein to refer to a subgenus of the one-or-more magnetoresponsive materials 102 in which the size of each discrete entity (e.g., particle) of the one-or-more magnetoresponsive submicron materials 134 is readily given in nanometers. Likewise, the term “magnetoresponsive micron-sized materials” is used herein to refer to a subgenus of the one-or-more magnetoresponsive materials 102 in which the size of each discrete entity (e.g., particle) of the one-or-more magnetoresponsive micron-sized materials 136 is readily given in microns or micrometers. Therefore, the scale of the one-or-more magnetoresponsive materials 102 can range from nanometers to micrometers. For example, the coating 130 can include nanostructures such as nanoparticles or nanorods of iron, iron oxide (e.g., magnetite [FesCU]), cobalt, cobalt oxide, nickel, nickel oxide, or some combination thereof; microstructures such as microparticles or microrods of iron, iron oxide, cobalt, cobalt oxide, nickel, nickel oxide, or some combination thereof; or some combination of the foregoing nanostructures and microstructures. Additionally or alternatively, the one-or-more magnetoresponsive materials 102 can include so-called nanobots or microbots, which also range from at least nanometers to micrometers. See, for example, the following reference, which is incorporated herein by reference in itsentirety: Zhou, Huaijuan, et al. “Magnetically driven micro and nanorobots.” Chemical Reviews 121.8 (2021): 4999-5041. Lastly, for expository expediency, description of any embodiment set forth herein with respect to the one-or-more magnetoresponsive submicron materials 134 should be understood to extend to the one-or-more magnetoresponsive micronsized materials 136 for such embodiments. That said, any magnetoresponsive submicron materials 134 appearing in the claims should be construed in accordance with their nanometersized discrete entities (e.g., particles), and any magnetoresponsive micron-sized materials 136 appearing in the claims should be construed in accordance with their micron-sized discrete entities (e.g., particles).

[0079] FIGS. 3 and 4 illustrate transverse cross sections of the distal portion of the elongate medical device 106 including the coating 130 of the one-or-more magnetoresponsive materials 102 in accordance with some embodiments.

[0080] As shown in FIG. 3, the coating 130 can be formed of the one-or-more magnetoresponsive submicron materials 134, wherein the one-or-more magnetoresponsive submicron materials 134 are deposited on at least the distal portion of the elongate medical device 106. Alternatively, as shown in FIG. 4, the coating 130 can be formed of the other coating material 138 (e.g., the biocompatible polymer) with the one-or-more magnetoresponsive submicron materials 134 disposed or embedded in the coating 130 of the other coating material 138 on at least the distal portion of the elongate medical device 106.

[0081] FIG. 12 illustrates a first mechanism of local hypothermia for disrupting thrombotic or non-thrombotic occlusions in accordance with some embodiments in accordance with some embodiments.

[0082] As shown, the magnetic field generated by the magnetic-field generator 108 causes the one-or-more magnetoresponsive submicron materials 134 of the coating 130 shown in at least FIGS. 3 and 4 to resonate therewith. Subsequent energy loss of the one-or-more magnetoresponsive submicron materials 134 through relaxation of the one-or-more magnetoresponsive submicron materials 134 causes lattice vibrations (e.g., via Neel relaxation) and, thus, local hypothermia in the portion (e.g., the distal portion, the distal end portion, or the distal end) of the elongate medical device 106 over which the coating 130 extends for disrupting the thrombotic or non-thrombotic occlusions, if present. Notably, however, the local hypothermia in the foregoing portion of the elongate medical device 106 can also result fromBrownian relaxation, which relates to relaxation of physical rotation of the one-or-more magnetoresponsive submicron materials 134 of the coating 130.

[0083] FIGS. 5 and 6 illustrate additional transverse cross sections of the distal portion of the elongate medical device 106 including the coating 130 of the one-or-more magnetoresponsive materials 102 in accordance with some embodiments.

[0084] As shown in FIG. 5, the coating 130 can be formed of the one-or-more magnetoresponsive submicron materials 134, wherein the one-or-more magnetoresponsive submicron materials 134 are deposited on at least the distal portion of the elongate medical device 106 similar to that shown in FIG. 3. In addition, however, one or more therapeutic agents 144 (e.g., thrombolytics such as a recombinant tissue-type plasminogen activator including alteplase, reteplase, or tenecteplase; antimicrobials or antibiotics such as ciprofloxacin, vancomycin, gentamicin, daptomycin, azithromycin, or one or more rifamycins; etc.) can be deposited on at least the distal portion of the elongate medical device 106 along with the one- or-more magnetoresponsive submicron materials 134 for targeted delivery upon release. Indeed, the one-or-more therapeutic agents 144 can be disposed in the coating 130 of one-or- more magnetoresponsive submicron materials 134 or vice versa. Alternatively, as shown in FIG. 6, the coating 130 can be formed of the other coating material 138 (e.g., the biocompatible polymer) with the one-or-more magnetoresponsive submicron materials 134 disposed or embedded in the coating 130 of the other coating material 138 on at least the distal portion of the elongate medical device 106 similar to that shown in FIG. 4. In addition, however, the one- or-more therapeutic agents 144 can be disposed or embedded in the coating 130 of the other coating material 138 on at least the distal portion of the elongate medical device 106 along with the one-or-more magnetoresponsive submicron materials 134 for targeted delivery upon release.

[0085] Notwithstanding the foregoing, however, it should be understood the one-or- more therapeutic agents 144 can be generated (e.g., reactive oxygen species [“ROS”] such as hydroxyl radicals) by the one-or-more magnetoresponsive submicron materials 134 as set forth in the following reference, which is incorporated herein in its entirety: Voinov, Maxim A., et al. “Surface-mediated production of hydroxyl radicals as a mechanism of iron oxide nanoparticle biotoxicity.” Journal of the American Chemical Society 133.1 (2011): 35-41. In such embodiments, the coating 130 is formed of the one-or-more magnetoresponsive submicron materials 134 deposited on at least the distal portion of the elongate medical device106 as shown in FIG. 3, or the coating 130 is formed of the other coating material 138 (e.g., the biocompatible polymer) with the one-or-more magnetoresponsive submicron materials 134 disposed or embedded in the coating 130 of the other coating material 138 on at least the distal portion of the elongate medical device 106 as shown in FIG. 4. However, release of the one- or-more therapeutic agents 144 from the coating 130, which one-or-more therapeutic agents 144 can be the ROS, follows a mechanism akin to the second mechanism set forth below in reference to FIG. 13.

[0086] FIG. 13 illustrates a second mechanism of therapeutic-agent release from the coating 130 of the one-or-more magnetoresponsive submicron materials 134 for disrupting the thrombotic or non-thrombotic occlusions in accordance with some embodiments in accordance with some embodiments. However, FIG. 13 can alternatively be interpreted as illustrating a third mechanism of magnetoresponsive-material release from the coating 130 of the one-or- more magnetoresponsive submicron materials 134 for disrupting the thrombotic or non- thrombotic occlusions in accordance with some embodiments.

[0087] While the magnetic field generated by the magnetic-field generator 108 can cause the one-or-more magnetoresponsive submicron materials 134 to resonate therewith and, thereby, cause lattice vibrations and, thus, local hypothermia in the portion (e.g., the distal portion, the distal end portion, or the distal end) of the elongate medical device 106 over which the coating 130 extends, the magnetic field generated by the magnetic-field generator 108 can additionally or alternatively cause the one-or-more magnetoresponsive submicron materials 134 to resonate therewith and, thus, release the one-or-more therapeutic agents 144 from at least the portion (e.g., the distal portion, the distal end portion, or the distal end) of the elongate medical device 106 over which the coating 130 extends for disrupting the thrombotic or non- thrombotic occlusions, if present. Further, in accordance with the alternative interpretation of FIG. 13 set forth above, the magnetic field generated by the magnetic-field generator 108 can additionally or alternatively cause the one-or-more magnetoresponsive submicron materials 134 to resonate therewith and, thus, release some of the one-or-more magnetoresponsive submicron materials 134 from at least the portion (e.g., the distal portion, the distal end portion, or the distal end) of the elongate medical device 106 over which the coating 130 extends for disrupting the thrombotic or non-thrombotic occlusions, if present.

[0088] The one-or-more magnetoresponsive materials 102 are primarily set forth herein as forming at least the distal portion of the elongate medical device 106, beingincorporated into at least the distal portion of the elongate medical device 106, forming the coating 130 over at least the distal portion of the elongate medical device 106, and the like, however, the one-or-more magnetoresponsive materials 102 can alternatively be directly administered or otherwise delivered via another elongate medical device to an intravenous catheter similar to the intravenous catheter 112 or, for enhanced medical treatment, the intravenous catheter 112, itself, for disrupting any thrombotic or non-thrombotic occlusions thereof. Optionally, the one-or-more therapeutic agents 144 set forth herein can be coadministered with the one-or-more magnetoresponsive materials 102 to any of the foregoing intravenous catheters for disrupting any thrombotic or non-thrombotic occlusions thereof. Advantageously, directly administering the one-or-more magnetoresponsive materials 102 to such intravenous catheters expands the scope of the one-or-more magnetoresponsive materials 102 that can be used for disrupting any thrombotic or non-thrombotic occlusions of the intravenous catheter 112.

[0089] Regarding expanding the scope of the one-or-more magnetoresponsive materials 102 by directly administering the one-or-more magnetoresponsive materials 102 to the intravenous catheters, the scope of the one-or-more magnetoresponsive materials 102 can be expanded to, for example, shape-transforming magnetoresponsive materials such as the gallium-based liquid metal set forth in the following reference, which is incorporated herein by reference in its entirety: Elboume, Aaron, et al. “Antibacterial liquid metals: biofilm treatment via magnetic activation.” ACS nano 14.1 (2020): 802-817. Notably, when the foregoing gallium-based liquid metal is exposed to or held under a magnetic field like that of the magnetic-field generator 108 for a sufficient period of time, discrete entities (e.g., droplets) of the gallium-based liquid metal actuate and transform their shapes to develop sharp edges that break down thrombotic or non-thrombotic occlusions, particularly those of biofilms by rupturing bacterial cell walls with the sharp edges. Advantageously, the ultrasound probe 160 can be configured to locally disperse and, optionally, emulsify the gallium-based liquid metal by way of ultrasound cavitation when the gallium-based liquid metal is present as a bolus in the distal portion of any of the foregoing intravenous catheters. Not only can application of ultrasound, itself, break down and, thus, disrupt thrombotic or non-thrombotic occlusions in the intravenous catheters, but dispersion of the gallium-based liquid metal by way of ultrasound cavitation ensures that there is a sufficient population of the discrete entities (e.g., droplets) of the gallium-based liquid metal for timely disruption of any thrombotic or non-thrombotic occlusions of the intravenous catheters.

[0090] FIGS. 17 and 19 illustrate detailed views of the distal portion of the elongate medical device 106 including different pluralities of magnetoresponsive structures 104 incorporated into the abluminal surface 148 of the elongate medical device 106 in accordance with some embodiments.

[0091] As to the one-or-more magnetoresponsive structures 104, at least the distal portion of the elongate medical device 106 such as the distal end portion of the elongate medical device 106 (e.g., the distal tip of the intravenous catheter 112, the inflatable portion 126 of the companion implement 124, the steerable portion 128 of the companion implement 124) can include the one-or-more magnetoresponsive structures 104 for administering the medical treatment. That said, up to an entirety of the elongate medical device 106 can include the one- or-more magnetoresponsive structures 104 for administering the medical treatment. Further, the elongate medical device 106 can include a plurality of a magnetoresponsive structures 104 thereon, for example, incorporated into a luminal surface 146, an abluminal surface 148, or both the luminal and abluminal surfaces 146 and 148 of the elongate medical device 106.

[0092] The plurality of magnetoresponsive structures 104 are responsive to the magnetic field generated by the magnetic-field generator 108 when the magnetic field is directed toward the portion (e.g., the distal portion, the distal end portion, or the distal end) of the elongate medical device 106 including the plurality of a magnetoresponsive structures 104 thereon. Indeed, when the magnetic field is directed toward the portion of the elongate medical device 106 including the plurality of the magnetoresponsive structures 104 for a sufficient period of time, the medical treatment is administered, which medical treatment includes actuating the plurality of magnetoresponsive structures 104 to disrupt any thrombotic or non- thrombotic occlusions present in the elongate medical device 106, for example, break up or dissolve the thrombotic occlusions or break up the non-thrombotic occlusions of bacterial biofilms.

[0093] FIG. 18 illustrates a detailed view of a cantilever 150 for a magnetoresponsive structure of the plurality of magnetoresponsive structures 104 in accordance with some embodiments.

[0094] As shown, the plurality of magnetoresponsive structures 104 can include a plurality of magnetoresponsive microstructures such as a plurality of cantilevers 150 like those set forth in the following reference, which is incorporated herein by reference in its entirety:Leulmi Pichot, Selma, et al. “Magneto-mechanically actuated microstructures to efficiently prevent bacterial biofilm formation.” Scientific Reports 10.1 (2020): 15470. However, instead of the plurality of cantilevers 150 being fabricated on an elemental silicon substrate, the plurality of cantilevers 150 can be either fabricated on silicone or another biocompatible polymer of the elongate medical device 106 or transferred thereto, for example, by soft lithography, notably with a spacing between free extremities of the cantilevers 150 that optimizes efficacy in disrupting thrombotic or non-thrombotic occlusions with operability of the cantilevers 150, which operability can be affected by the flexibility of the elongate medical device 106 when the cantilevers 150 are too close to each other. For example, a bend in the elongate medical device 106 can result in tension on a side of the elongate medical device 106 and compression on an opposite side thereof, which compression results in the cantilevers 150 on the opposite side of the elongate medical device 106 being closer to each other. The spacing between the free extremities of the cantilevers 150 takes such compression into account for optimized efficacy in disrupting thrombotic or non-thrombotic occlusions with operability of the cantilevers 150.

[0095] When the magnetic field of the magnetic-field generator 108 is directed toward the portion of the elongate medical device 106 including the plurality of cantilevers 150 for a sufficient period of time, the medical treatment is administered, which medical treatment includes actuating the plurality of cantilevers 150 and, thereby, causing each operable cantilever 150 of the plurality of cantilevers 150 to deflect in toward or away from the luminal or abluminal surface 146 or 148 of the elongate medical device 106 at its free extremity. Notably, such deflection can be in accordance or resonance with a frequency of the alternating magnetic field, which, in some embodiments, can be as low as 100 Hz, 50 Hz, 40 Hz, 30 Hz, 20 Hz, 10 Hz, 5 Hz, 3 Hz, 1 Hz, 0.5 Hz, 0.3 Hz, or 0.10 Hz. Insofar as at least bacterial biofilms such as those that can form during CRB Sis, deflection of the plurality of cantilevers 150 at such a frequency over a period of time prevents significant bacterial adhesion to the luminal or abluminal surface 146 or 148 of the elongate medical device 106 and, thereby, subsequent bacterial growth into biofilms. As such, the plurality of cantilevers 150 can advantageously mitigate antimicrobial resistant infections, eliminate the biofilms thereof, or even prophylactically prevent them in the first place.

[0096] FIG. 20 illustrates a detailed view of a pillar 152 for a magnetoresponsive structure of the plurality of magnetoresponsive structures 104 in accordance with some embodiments.

[0097] As set forth above, the plurality of magnetoresponsive structures 104 can include the plurality of magnetoresponsive microstructures; however, as shown, the plurality of magnetoresponsive microstructures can alternatively be a plurality of pillars 152 like those set forth in the following reference, which is incorporated herein by reference in its entirety: Gu, Huan, et al. “Magnetically driven active topography for long-term biofilm control.” Nature Communications 11.1 (2020): 2211. Notably, the plurality of pillars 152 can be being fabricated directly on silicone or another biocompatible polymer of the elongate medical device 106 in accordance with the foregoing reference, but spacing between the pillars 152 should be optimized, like that set forth above, for efficacy in disrupting thrombotic or non-thrombotic occlusions with operability of the pillars 152, which operability can be affected by the flexibility of the elongate medical device 106 when the pillars 152 are too close to each other. For example, a bend in the elongate medical device 106 can result in tension on a side of the elongate medical device 106 and compression on an opposite side thereof, which compression results in the pillars 152 on the opposite side of the elongate medical device 106 being closer to each other. The spacing between the pillars 152 takes such compression into account for optimized efficacy in disrupting thrombotic or non-thrombotic occlusions with operability of the pillars 152.

[0098] When the magnetic field of the magnetic-field generator 108 is directed toward the portion of the elongate medical device 106 including the plurality of pillars 152 for a sufficient period of time, the medical treatment is administered, which medical treatment includes actuating the plurality of pillars 152 and, thereby, causing each operable pillar 152 of the plurality of pillars 152 to sway over the luminal or abluminal surface 146 or 148 of the elongate medical device 106. Notably, such sway can be in accordance or resonance with a frequency of the alternating magnetic field, which, in some embodiments, can be as low as 100 Hz, 50 Hz, 40 Hz, 30 Hz, 20 Hz, 10 Hz, 5 Hz, 3 Hz, 1 Hz, 0.5 Hz, 0.3 Hz, or 0.10 Hz. Insofar as at least bacterial biofilms such as those that can form during CRB Sis, sway of the plurality of pillars 152 at such a frequency over a period of time prevents significant bacterial adhesion to the luminal or abluminal surface 146 or 148 of the elongate medical device 106 and, thereby, subsequent bacterial growth into biofilms. As such, the plurality of pillars 152 canadvantageously mitigate antimicrobial resistant infections, eliminate the biofilms thereof, or even prophylactically prevent them in the first place.Magnetic field-generating system or subsystems

[0099] FIG. 7 illustrates a dedicated console 154 and the magnetic-field generator 108 forming a dedicated magnetic field-generating system 156 of the therapeutic system 100 in accordance with some embodiments. FIG. 8 illustrates an ultrasound console 158 and an ultrasound probe 160 including a magnetic field-generating subsystem as part of the therapeutic system 100 in accordance with some embodiments.

[0100] As shown, the console 110 of the therapeutic system 100 can be the dedicated console 154 configured to drive the magnetic-field generator 108 operably coupled thereto, wherein the dedicated console 154 and the magnetic-field generator 108 form the dedicated magnetic field-generating system 156 of the therapeutic system 100. Alternatively, the console 110 of the therapeutic system 100 can be the ultrasound console 158. Further, the magnetic- field generator 108 can be integrated into the ultrasound probe 160 operably coupled to the ultrasound console 158, wherein the ultrasound console 158 is configured for both ultrasound imaging with the ultrasound probe 160 and driving the magnetic-field generator 108 thereof. In such embodiments, the magnetic field-generating system of the therapeutic system 100 is the magnetic field-generating subsystem of an ultrasound system 162, wherein the magnetic field-generating subsystem of the ultrasound system 162 up to an entirety of the ultrasound system 162 can be considered part of the therapeutic system 100. Advantageously, the magnetic field-generating subsystem of the ultrasound system 162 provides additional functionality to an ultrasound system that synergistically allows for both visualization of thrombotic and non- thrombotic occlusions of an intravenous catheter, if present, as well as the medical treatment set forth herein for any thrombotic and non-thrombotic occlusions. Further, the additional functionality of the magnetic field-generating subsystem is provided to such an ultrasound system that is otherwise already familiar to users of ultrasound systems. Notwithstanding the foregoing, the dedicated console 154 and the magnetic-field generator 108 can alternatively adopt the form factor of the ultrasound system 162 without any ultrasound-imaging functionality for form-factor familiarity to the users of ultrasound systems.

[0101] FIG. 9 illustrates a block diagram of the ultrasound console 158 and the ultrasound probe 160 in accordance with some embodiments.

[0102] It should be understood that while the ultrasound system 162 is described below with reference to the block diagram of FIG. 9, the magnetic field-generating subsystem of the ultrasound system 162 and the dedicated magnetic field-generating system 156 of the therapeutic system 100 have various components in common. As such, description of the components of the dedicated console 154 and the magnetic-field generator 108 of the dedicated magnetic field-generating system 156 of the therapeutic system 100 can be extracted from description of at least the magnetic field-generating subsystem of the ultrasound system 162. For this reason, various components of the dedicated console 154 and the magnetic-field generator 108 of the dedicated magnetic field-generating system 156 are identified in the drawings with reference numbers used in the description for the ultrasound console 158 and the magnetic-field generator 108 of the ultrasound probe 160 of the magnetic field-generating subsystem of the ultrasound system 162.

[0103] The ultrasound console 158 can include one or more processors 164 and memory 166 including instructions 168 stored thereon configured to instantiate one or more processes when executed by the one-or-more processors 164 for controlling various functions of the ultrasound system 162 such as ultrasound imaging with the ultrasound probe 160, administering the medical treatment to disrupt any thrombotic or non-thrombotic occlusions in the intravenous catheter 112 or a similar intravenous catheter with the companion implement 124, or both. As to ultrasound imaging, some of the various functions can include sending emitted ultrasound signals into the patient, receiving echoed ultrasound signals from the patient, or processing the echoed ultrasound signals into ultrasound-imaging data for visualizing any thrombotic or non-thrombotic occlusions of the intravenous catheter 112 or a similar intravenous catheter, the companion implement 124 in any catheter of the foregoing intravenous catheters, or both. As to administering the medical treatment, some of the various functions can include driving the magnetic-field generator 108 or actuating the one-or-more magnetoresponsive materials 102 or structures 104 of the elongate medical device 106. For example, actuating the one-or-more magnetoresponsive materials 102 or structures 104 of the elongate medical device 106 can include actuating the one-or-more magnetoelastic materials 132 thereof and, thereby, deforming the one-or-more magnetoelastic materials 132 to disrupt any thrombotic or non-thrombotic occlusions; causing the one-or-more magnetoresponsive submicron materials 134 to resonate with the magnetic field and, thus, cause local hypothermia, release of some of the one-or-more magnetoresponsive submicron materials 134, release of the one-or-more therapeutic agents 144, or some combination thereof to disrupt any thrombotic ornon-thrombotic occlusions; or actuating the plurality of magnetoresponsive structures 104 to disrupt any thrombotic or non-thrombotic occlusions.

[0104] The ultrasound console 158 can further include a display screen 170 integrated therein; however, the display screen 170 can alternatively be separated from the ultrasound console 158 and communicatively coupled thereto. The display screen 170 can be configured to provide a graphical user interface (“GUI”) and display information thereon such as ultrasound images including at least the blood vessel 214 of the patient in which the intravenous catheter 112 or a similar intravenous catheter (e.g., CVC, PICC, etc.) is placed, optionally, with any thrombotic or non-thrombotic occlusions.

[0105] The ultrasound console 158 can further include a console button interface 172 with one or more physical buttons 174 configured to immediately call up to the display screen 170 one or more desired ultrasound- system modes such as a scan mode for collecting ultrasound-imaging data for displaying the ultrasound images on the display screen 170 or a treatment mode for driving the magnetic-field generator 108 and actuating the one-or-more magnetoresponsive materials 102 or structures 104 of the elongate medical device 106 to disrupt any thrombotic or non-thrombotic occlusions. However, the ultrasound console 158 can additionally or alternatively include one or more on-screen buttons 176 provided by the GUI as shown in FIG. 8.

[0106] The ultrasound console 158 can further include a digital controller / analog interface 178 configured to communicate with the one-or-more processors 164, other components of the ultrasound console 158, and other components of the ultrasound system 162 such as the array of ultrasound transducers 190 or magnets of the ultrasound probe 160 to govern interfacing between the foregoing components.

[0107] The ultrasound console 158 can further include a power connection 180 configured to enable an operable connection to an external power supply 182. Additionally or alternatively, the ultrasound console 158 can include an internal power supply 184 (e.g., a battery). Whether or not the ultrasound console 158 includes the internal power supply 184, the ultrasound console 158 includes power management circuitry 186 with the digital controller / analog interface 178 for power regulation and distribution. Indeed, such power regulation and distribution includes powering the magnetic-field generator 108 when generating the magnetic field therewith, which can include generating the magnetic field withalternating current for the alternating magnetic field set forth below. Notably, the power requirement for the magnetic-field generator 108 can range from at least about 0.1 kW to no more than about 5.0 kW, including at least about 0.5 kW to no more than about 4.0 kW, such as at least about 1.0 kW to no more than about 4.0 kW, for example, at least about 1.0 kW to no more than about 3.5 kW, at least about 1.0 kW to no more than about 3.0 kW, or at least about 1.0 kW to no more than about 2.5 kW for an hour of use. Depending upon an amount, concentration, or both of the one-or-more magnetoresponsive materials 102 or structures 104 in at least the distal portion of the elongate medical device 106, such power is sufficient to disrupt any thrombotic or non-thrombotic occlusions with the elongate medical device 106 at a depth up to at least 5 cm, 10 cm, or 15 cm.

[0108] The ultrasound probe 160 can include a probe head 188 that houses an array of ultrasound transducers 190, wherein the array of ultrasound transducers 190 includes piezoelectric transducers or capacitive micromachined ultrasound transducers (“CMUTs”). Such a probe head 188 of the ultrasound probe 160 is configured to be placed against skin of the patient for emitting the ultrasound signals into the patient and receiving the echoed ultrasound signals from the patient.

[0109] The ultrasound probe 160 can include magnets housed in the probe head 188 along with the array of ultrasound transducers 190. For example, the probe head 188 can include one or more magnetic field-generating electromagnets 192 such as a plurality of the magnetic field-generating electromagnets 192 (e.g., a pair of the magnetic field-generating electromagnets 192) for generating the magnetic field, which can be an alternating magnetic field in some embodiments. Optionally, the probe head 188 can also include a maneuverability magnet 194, which can also be an electromagnet, for maneuvering any of the one-or-more magnetoresponsive materials 102, structures 104, or the like capable of being maneuvered such as any free nanoparticles or microparticles (e.g., nanoparticles or microparticles released from the coating 130, nanoparticles or microparticles deposited in an intravenous catheter such as the intravenous catheter 112, or some combination thereof). The probe head 188 of the ultrasound probe 160 is further configured to be placed against the skin of the patient for actuating the one-or-more magnetoresponsive materials 102 or structures 104 of the elongate medical device 106 or maneuvering any free nanoparticles or microparticles such as moving the free nanoparticles or microparticles, if present, into contact with any thrombotic or non- thrombotic occlusions.

[0110] Notably, with respect to the magnetic-field generator 108 of the dedicated magnetic field-generating system 156 of the therapeutic system 100, but extensible to the magnetic-field generator 108 of the ultrasound probe 160, the one-or-more magnetic fieldgenerating electromagnets 192 for generating the magnetic field can be arranged in an ellipse, which, notably, encompasses a circle in the special case where the two focal points of the ellipse are coincident at the geometric center of the ellipse. Such an arrangement of the one-or-more magnetic field-generating electromagnets 192 facilitates generation of a single alternating magnetic field for the magnetic field. In an example, a single magnetic field-generating electromagnet can have a coil with a diameter commensurate with that of the circular arrangement of the plurality of magnetic field-generating electromagnets 192 around the head 196 of the magnetic-field generator 108 in FIG. 7. The single magnetic field-generating electromagnet can be configured to generate the single alternating magnetic field. In another example, the plurality of magnetic field-generating electromagnets 192 around the head 196 of the magnetic-field generator 108 shown in FIG. 7 can be configured to generate the single alternating magnetic field by superposition of each magnetic field generated by the plurality of magnetic field-generating electromagnets 192.[OHl] The ultrasound probe 160 can further include a button-and-memory controller 198 for governing button operation of one or more physical buttons 200 configured for operating the magnetic-field generator 108, as well as operating the ultrasound probe 160 itself. In an example, the one-or-more physical buttons 200 can include an on-off button for switching the magnetic field-generating electromagnets 192 on or off. In another example, the one-or- more physical buttons 200 can include another on-off button for switching the maneuverability magnet 194 on or off. The button-and-memory controller 198 is in operable communication with a probe interface 201 of the ultrasound console 158, which includes an input / output (“VO”) component 202 for interfacing with the array of ultrasound transducers 190 or magnets and a button-and-memory I / O component 204 for interfacing with the button-and-memory controller 198.Methods

[0112] FIGS. 10, 11, and 14 illustrate an occlusion-disrupting operation of a method of the using the therapeutic system 100 or the therapeutic system 100 itself in accordance with some embodiments.

[0113] Also disclosed herein are methods of the therapeutic system 100 for medical treatment. Such methods include at least a method of using the therapeutic system 100 and a method of the therapeutic system 100 itself. For example, the method of the therapeutic system 100 itself can include a magnetic field-driving operation, a magnetic field-generating operation, a magnetic field-responding operation, and the occlusion-disrupting operation.

[0114] The magnetic field-driving operation can include driving the magnetic-field generator 108 with the dedicated console 154 or the ultrasound console 158 having the one-or- more processors 164 as well as the memory 166 having the instructions 168 stored thereon for the driving of the magnetic-field generator 108 when the instructions 168 are executed by the one-or-more processors 164.

[0115] The magnetic field-generating operation can include generating a magnetic field with the magnetic-field generator 108.

[0116] The magnetic field-responding operation can include responding to the magnetic field by the distal portion of the elongate medical device 106 to administer the medical treatment. As set forth above, at least the distal portion of the elongate medical device 106 can include the coating 130 thereover, wherein the coating 130 can include the one-or- more magnetoresponsive submicron materials 134 for responding to the magnetic field. Alternatively, at least the distal portion of the elongate medical device 106 can include the plurality of magnetoresponsive structures 104 incorporated into the surface of the elongate medical device 106 for responding to the magnetic field. Further alternatively, at least the distal portion of the elongate medical device 106 can include the one-or-more magnetoelastic materials 132 incorporated into the elongate medical device 106 or forming an entirety of the distal portion of the elongate medical device 106 for responding to the magnetic field.

[0117] The occlusion-disrupting operation can include disrupting any thrombotic or non-thrombotic occlusions, if present, on the distal portion of elongate medical device 106 (e.g., the intravenous catheter 112) or with the distal portion of the elongate medical device 106 (e.g., the companion implement 124) upon responding to the magnetic field.

[0118] While some particular embodiments have been disclosed herein, and while the particular embodiments have been disclosed in some detail, it is not the intention for the particular embodiments to limit the scope of the concepts provided herein. Additional adaptations or modifications can appear to those of ordinary skill in the art, and, in broaderaspects, these adaptations or modifications are encompassed as well. Accordingly, departures may be made from the particular embodiments disclosed herein without departing from the scope of the concepts provided herein.

Claims

CLAIMSWhat is claimed is:

1. A therapeutic system for medical treatment using one or more magnetoresponsive materials, comprising: an elongate medical device including: a primary lumen; and a coating selected from a luminal coating, an abluminal coating, and a combination of both the luminal and abluminal coatings over at least a distal portion of the elongate medical device, the coating including one or more magnetoresponsive submicron materials for the one-or-more magnetoresponsive materials; and a magnetic-field generator, the one-or-more magnetoresponsive submicron materials responsive to a magnetic field generated by the magnetic-field generator when directed toward the coating for effectuating the medical treatment, which medical treatment is selected from local hypothermia, targeted delivery of one or more therapeutic agents, and combinations thereof to disrupt any thrombotic or non-thrombotic occlusions.

2. The therapeutic system of claim 1, further comprising a console configured to drive the magnetic-field generator, the console including one or more processors and memory having instructions stored thereon that drive the magnetic field generator when executed by the one-or-more processors.

3. The therapeutic system of claim 2, wherein the console and the magnetic-field generator form a dedicated magnetic field-generating system of the therapeutic system.

4. The therapeutic system of claim 2, wherein the console is an ultrasound console configured for both ultrasound imaging and driving the magnetic-field generator, and the magnetic-field generator is integrated into an ultrasound probe.

5. The therapeutic system of any claim of claims 1 -4, wherein the elongate medical device is an intravenous catheter, the distal portion of the elongate medical device including a distal tip such that the coating extends over the distal tip for disrupting the thrombotic or non- thrombotic occlusions thereof, if present.

6. The therapeutic system of any claim of claims 1 -4, wherein the elongate medical device is a dedicated companion implement to the magnetic-field generator of the therapeutic system, the companion implement configured for insertion into one or more lumens of an intravenous catheter.

7. The therapeutic system of claim 6, wherein the distal portion of the elongate medical device includes a distal tip such that the coating extends over the distal tip for contacting and disrupting the thrombotic or non-thrombotic occlusions in the one-or-more lumens of the intravenous catheter, if present.

8. The therapeutic system of claim 7, wherein the distal portion of the elongate medical device including the coating is inflatable for the contacting and disrupting of the thrombotic or non-thrombotic occlusions in the one-or-more lumens of the intravenous catheter, if present, the primary lumen configured as an inflation lumen for inflating the distal portion of the elongate medical device.

9. The therapeutic system of claim 7, wherein the companion instrument is steerable for the contacting and disrupting of the thrombotic or non-thrombotic occlusions in the one-or-more lumens of the intravenous catheter, if present, the primary lumen including a steering element disposed therein for steering the companion implement.

10. The therapeutic system of any claim of claims 1-9, wherein the coating includes the one-or-more magnetoresponsive submicron materials deposited on at least the distal portion of the elongate medical device.

11. The therapeutic system of any claim of claims 1-9, wherein the coating includes the one-or-more magnetoresponsive submicron materials embedded in a coating material on at least the distal portion of the elongate medical device.

12. The therapeutic system of either claim 10 or 11, wherein the coating includes the one-or-more magnetoresponsive submicron materials and the one-or-more therapeutic agents deposited on at least the distal portion of the elongate medical device or embedded in a coating material on at least the distal portion of the elongate medical device.

13. The therapeutic system of any claim of claims 1-12, wherein the magnetic field generated by the magnetic-field generator causes the one-or-more magnetoresponsivesubmicron materials to resonate therewith, subsequent energy loss of the one-or-more magnetoresponsive submicron materials through relaxation of the one-or-more magnetoresponsive submicron materials causing lattice vibrations and, thus, local hypothermia in at least the distal portion of the elongate medical device for disrupting the thrombotic or non- thrombotic occlusions, if present.

14. The therapeutic system of any claim of claims 1-12, wherein the magnetic field generated by the magnetic-field generator causes the one-or-more magnetoresponsive submicron materials to resonate therewith and, thus, release the one-or-more therapeutic agents from at least the distal portion of the elongate medical device for disrupting the thrombotic or non-thrombotic occlusions, if present.

15. The therapeutic system of any claim of claims 1-14, wherein each occlusion of the thrombotic or non-thrombotic occlusions is selected from an intraluminal thrombus, a fibrin tail, a fibrin sheath, a mural thrombus, a biofilm, a lipid residue, a precipitated drug, and some combination thereof.

16. A therapeutic system for medical treatment using magnetoresponsive structures, comprising: an elongate medical device including: a primary lumen; and a plurality of magnetoresponsive structures incorporated into a luminal surface, an abluminal surface, or a combination of both the luminal and abluminal surfaces over at least a distal portion of the elongate medical device; and a magnetic-field generator, the one-or-more magnetoresponsive structures responsive to a magnetic field generated by the magnetic-field generator when directed toward the distal portion of the elongate medical device for effectuating the medical treatment, which medical treatment includes actuating the plurality of magnetoresponsive structures to disrupt any thrombotic or non-thrombotic occlusions.

17. The therapeutic system of claim 16, further comprising a console configured to drive the magnetic-field generator, the console including one or more processors and memoryhaving instructions stored thereon that drive the magnetic field generator when executed by the one-or-more processors.

18. The therapeutic system of claim 17, wherein the console and the magnetic-field generator form a dedicated magnetic field-generating system of the therapeutic system.

19. The therapeutic system of claim 17, wherein the console is an ultrasound console configured for both ultrasound imaging and driving the magnetic-field generator, and the magnetic-field generator is integrated into an ultrasound probe.

20. The therapeutic system of any claim of claims 16-19, wherein the elongate medical device is an intravenous catheter, the plurality of magnetoresponsive structures incorporated into the distal portion of the elongate medical device including a distal tip of the intravenous catheter for disrupting the thrombotic or non-thrombotic occlusions thereof, if present.

21. The therapeutic system of any claim of claims 16-20, wherein each occlusion of the thrombotic or non-thrombotic occlusions is selected from an intraluminal thrombus, a fibrin tail, a fibrin sheath, a mural thrombus, a biofilm, a lipid residue, a precipitated drug, and some combination thereof.

22. A therapeutic system for medical treatment using a magnetoelastic material, comprising: an elongate medical device including a primary lumen, the elongate medical device including at least a distal portion formed of the magnetoelastic material or incorporating the magnetoelastic material therein; and a magnetic-field generator, the magnetoelastic material responsive to a magnetic field generated by the magnetic-field generator when directed toward the distal portion of the elongate medical device for effectuating the medical treatment, which medical treatment includes actuating the magnetoelastic material to disrupt any thrombotic or non- thrombotic occlusions.

23. The therapeutic system of claim 22, further comprising: a console configured to drive the magnetic-field generator, the console including one or more processors and memory having instructions storedthereon that drive the magnetic field generator when executed by the one- or-more processors.

24. The therapeutic system of claim 23, wherein the console and the magnetic-field generator form a dedicated magnetic field-generating system of the therapeutic system.

25. The therapeutic system of claim 23, wherein the console is an ultrasound console configured for both ultrasound imaging and driving the magnetic-field generator, and the magnetic-field generator is integrated into an ultrasound probe.

26. The therapeutic system of any claim of claims 22-25, wherein the elongate medical device is an intravenous catheter, the magnetoelastic material incorporated into the distal portion of the elongate medical device including a distal tip of the intravenous catheter for disrupting the thrombotic or non-thrombotic occlusions thereof, if present.

27. The therapeutic system of any claim of claims 22-26, wherein each occlusion of the thrombotic or non-thrombotic occlusions is selected from an intraluminal thrombus, a fibrin tail, a fibrin sheath, a mural thrombus, a biofilm, a lipid residue, a precipitated drug, and some combination thereof.

28. A method of a therapeutic system for medical treatment, comprising: generating a magnetic field with a magnetic-field generator; and responding to the magnetic field by a distal portion of an elongate medical device to effectuate the medical treatment, at least the distal portion of the elongate medical device including: a coating over the distal portion of the elongate medical device, the coating including one or more magnetoresponsive submicron materials for responding to the magnetic field; a plurality of magnetoresponsive structures incorporated into a surface of the distal portion of the elongate medical device for responding to the magnetic field; or a magnetoelastic material incorporated into the distal portion of the elongate medical device or forming an entirety of the distal portion of the elongate medical device for responding to the magnetic field; and disrupting any thrombotic or non-thrombotic occlusions, if present, on the distal portion of elongate medical device upon responding to the magnetic field.

29. The method of claim 28, further comprising driving the magnetic-field generator with a console including one or more processors and memory having instructions stored thereon for the driving of the magnetic-field generator when executed by the one-or- more processors.

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