Therapeutic systems and methods for medical treatment using magnetically responsive materials or structures

Abstract

Disclosed herein are treatment systems and methods for medical treatment using magnetically responsive materials and structures. For example, a treatment system can include an elongated medical device and a magnetic field generator. The elongated medical device can include an inner lumen coating, a distal inner lumen coating, or both, over at least a distal portion of the elongated medical device. Such coatings can include one or more magnetically responsive sub-micron materials that are responsive to a magnetic field generated by the magnetic field generator. When the magnetic field is directed at the coating, a medical treatment can be administered. The medical treatment can be selected from the group consisting of local hypothermia, targeted delivery of one or more therapeutic agents, and combinations thereof, for use in disrupting any thrombotic or non-thrombotic occlusion on the elongated medical device or another elongated medical device. Alternatives to the coating can include forming a distal portion of the elongated medical device with a magnetoelastic material or a magnetically responsive structure on the elongated medical device.

Description

[0001] priority

[0002] This application claims priority to U.S. Provisional Application No. 63 / 599,331, filed November 15, 2023, the entire contents of which are incorporated herein by reference. Background Technology

[0003] Occlusion in catheters (such as central venous catheters (“CVCs”) or peripherally inserted central catheters (“PICCs”)) can inhibit or even prevent fluid flow through such catheters. This can lead to ineffective drug-based treatment and complications such as infiltration, phlebitis, or infection. The aforementioned occlusion can occur in a variety of different ways. In one example, such as... Figure 21 As shown, thrombotic occlusion can occur when one or more thrombi form within, around, or at the distal portion of the catheter. In another example, nonthrombotic occlusion can occur due to biofilm formation during catheter-related bloodstream infection (“CRBSI”), lipid residues from lipid-containing nutrient mixtures or drug formulations including oily carriers, or drug precipitation from the same or different drug formulations within, around, or at the distal portion of the catheter. Existing solutions for medical treatment of thrombotic or nonthrombotic occlusion include antithrombotic or antimicrobial catheter coatings, antithrombotic or antimicrobial catheter sealing solutions, and the application of ultrasonic mechanical vibration; however, such existing solutions have limitations in their efficacy, particularly when antimicrobial resistant bacteria are involved.

[0004] In view of the foregoing, this article discloses a therapeutic system and method for medical treatment of thrombotic and non-thrombotic occlusions using magnetically responsive materials and structures. Summary of the Invention

[0005] This document discloses a therapeutic system for medical treatment using one or more magnetically responsive materials. In some embodiments, the therapeutic system includes an elongated medical device and a magnetic field generator. The elongated medical device includes a first lumen and a coating, the coating being selected from a lumen coating, a distal lumen coating, and a combination of both, located over at least a distal portion of the elongated medical device. The coating includes one or more magnetically responsive submicron materials for use with one or more magnetically responsive materials. The one or more magnetically responsive submicron materials respond to a magnetic field generated by the magnetic field generator when the magnetic field is directed toward the coating. In practice, when the magnetic field is directed toward the coating, a medical treatment is applied, the medical treatment being selected from local cryotherapy, targeted delivery of one or more therapeutic agents, and combinations thereof, to disrupt any thrombotic or non-thrombotic occlusion.

[0006] In some implementations, the treatment system also includes a console configured to drive a magnetic field generator. The console includes one or more processors and a memory storing instructions that, when executed by the one or more processors, drive the magnetic field generator.

[0007] In some implementations, the console and the magnetic field generator form a dedicated magnetic field generation system for the treatment system.

[0008] In some implementations, the console is an ultrasound console configured for both ultrasound imaging and driving a magnetic field generator. The magnetic field generator is integrated into the ultrasound detector.

[0009] In some implementations, the elongated medical device is an intravenous catheter. The distal portion of the elongated medical device includes a distal tip, such that a coating extends over the distal tip to disrupt thrombotic or non-thrombotic occlusions in the presence of the distal tip.

[0010] In some implementations, the elongated medical device is a dedicated accessory to the magnetic field generator of the treatment system. The accessory is configured for insertion into one or more lumens of an intravenous catheter.

[0011] In some embodiments, the distal portion of the elongated medical device includes a distal tip such that a coating extends over the distal tip to contact and disrupt thrombotic or nonthrombotic occlusions in one or more lumens of the intravenous catheter.

[0012] In some embodiments, the distal portion of the elongated medical device, including the coating, is inflatable to contact and disrupt thrombotic or non-thrombotic occlusions in one or more lumens of an intravenous catheter. A first lumen is configured as an inflatable lumen for inflating the distal portion of the elongated medical device.

[0013] In some embodiments, the accessory device is manipulatory to access and disrupt thrombotic or non-thrombotic occlusions in one or more lumens of the intravenous catheter. A first lumen includes a manipulatory element disposed therein for manipulating the accessory device.

[0014] In some implementations, the coating comprises one or more magnetically responsive submicron materials deposited on at least the distal portion of an elongated medical device.

[0015] In some embodiments, the coating includes one or more magnetically responsive submicron materials embedded in the coating material on at least the distal portion of the elongated medical device.

[0016] In some embodiments, the coating comprises one or more magnetically responsive submicron materials and one or more therapeutic agents deposited on or embedded in a coating material on at least the distal portion of an elongated medical device.

[0017] In some implementations, a magnetic field generated by a magnetic field generator induces resonance in one or more magnetically responsive submicron materials. Subsequently, relaxation of the one or more magnetically responsive submicron materials leads to energy loss in the materials, thereby causing lattice vibrations and thus localized low temperatures in at least the distal portion of the elongated medical device to disrupt thrombotic or non-thrombotic occlusions in their presence.

[0018] In some implementations, a magnetic field generated by a magnetic field generator causes one or more magnetically responsive submicron materials to resonate with it, and thus releases one or more therapeutic agents from at least a distal portion of the elongated medical device to disrupt thrombotic or nonthrombotic occlusions in the presence of such occlusions.

[0019] In some implementations, each type of thrombotic or non-thrombotic occlusion is selected from intraluminal thrombi, fibrin tails, fibrin sheaths, mural thrombi, biofilms, lipid residues, precipitated drugs, and some combination thereof.

[0020] This document also discloses a treatment system that uses one or more magnetically responsive structures for medical treatment. In some embodiments, the treatment system includes an elongated medical device and a magnetic field generator. The elongated medical device includes a first lumen and a plurality of magnetically responsive structures incorporated over at least a distal portion of the elongated medical device on a lumen surface, a distal lumen surface, or a combination of both. The one or more magnetically responsive structures respond to a magnetic field generated by the magnetic field generator when the magnetic field is directed toward the distal portion of the elongated medical device. In practice, when the magnetic field is directed toward the distal portion of the elongated medical device, a medical treatment is applied, which includes actuating the plurality of magnetically responsive structures to disrupt any thrombotic or non-thrombotic occlusion.

[0021] In some implementations, the treatment system also includes a console configured to drive a magnetic field generator. The console includes one or more processors and a memory storing instructions that, when executed by the one or more processors, drive the magnetic field generator.

[0022] In some implementations, the console and the magnetic field generator form a dedicated magnetic field generation system for the treatment system.

[0023] In some implementations, the console is an ultrasound console configured for both ultrasound imaging and driving a magnetic field generator. The magnetic field generator is integrated into the ultrasound detector.

[0024] In some implementations, the elongated medical device is an intravenous catheter. Multiple magnetically responsive structures are incorporated into the distal portion of the elongated medical device, including the distal end of the intravenous catheter, to disrupt thrombotic or non-thrombotic occlusions in the presence of such occlusions at the distal end.

[0025] In some implementations, each type of thrombotic or non-thrombotic occlusion is selected from intraluminal thrombi, fibrin tails, fibrin sheaths, mural thrombi, biofilms, lipid residues, precipitated drugs, and some combination thereof.

[0026] This document also discloses a treatment system using a magnetoelastic material for medical treatment. In some embodiments, the treatment system includes an elongated medical device and a magnetic field generator. The elongated medical device includes a first lumen and at least a distal portion formed of or incorporated therein by a magnetoelastic material. The magnetoelastic material responds to a magnetic field generated by the magnetic field generator when it is directed toward the distal portion of the elongated medical device. In practice, when the magnetic field is directed toward the distal portion of the elongated medical device, a medical treatment is applied, which includes actuating the magnetoelastic material to disrupt any thrombotic or non-thrombotic occlusion.

[0027] In some implementations, the treatment system also includes a console configured to drive a magnetic field generator. The console includes one or more processors and a memory storing instructions that, when executed by the one or more processors, drive the magnetic field generator.

[0028] In some implementations, the console and the magnetic field generator form a dedicated magnetic field generation system for the treatment system.

[0029] In some implementations, the console is an ultrasound console configured for both ultrasound imaging and driving a magnetic field generator. The magnetic field generator is integrated into the ultrasound detector.

[0030] In some implementations, the elongated medical device is an intravenous catheter. A magnetoelastic material is incorporated into the distal portion of the elongated medical device, including the distal end of the intravenous catheter, to disrupt thrombotic or non-thrombotic occlusions in the event of such occlusions at the distal end.

[0031] In some implementations, each type of thrombotic or non-thrombotic occlusion is selected from intraluminal thrombi, fibrin tails, fibrin sheaths, mural thrombi, biofilms, lipid residues, precipitated drugs, and some combination thereof.

[0032] This document also discloses a method for a therapeutic system used in medical treatment. In some embodiments, the method includes a magnetic field generation operation, a magnetic field response operation, and an occlusion destruction operation. The magnetic field generation operation includes generating a magnetic field using a magnetic field generator. The magnetic field response operation includes responding to the magnetic field by a distal portion of an elongated medical device to achieve the medical treatment. At least the distal portion of the elongated medical device includes a coating on the distal portion of the elongated medical device. Such a coating includes one or more magnetically responsive submicron materials for responding to the magnetic field. Alternatively, at least the distal portion of the elongated medical device includes a plurality of magnetically responsive structures incorporated into the surface of the distal portion of the elongated medical device for responding to the magnetic field. Furthermore, alternatively, at least the distal portion of the elongated medical device includes a magnetoelastic material incorporated into or forming integrally with the distal portion of the elongated medical device for responding to the magnetic field. The occlusion destruction operation includes destroying any thrombotic or non-thrombotic occlusion present in the distal portion of the elongated medical device when the distal portion of the elongated medical device responds to the magnetic field.

[0033] In some implementations, the method further includes magnetic field driving operations. Magnetic field driving operations include using a console comprising one or more processors and a memory storing instructions thereon to drive the magnetic field generator.

[0034] These and other features of the concepts provided herein will become more apparent to those skilled in the art in light of the accompanying drawings and the following description, which describe specific embodiments of such concepts in more detail. Attached Figure Description

[0035] Figure 1 A therapeutic system using one or more magnetically responsive materials or structures for medical treatment is shown according to some embodiments.

[0036] Figure 2A A slender medical device according to some implementation schemes is shown.

[0037] Figure 2B A transverse cross-section of the distal portion of an elongated medical device according to some embodiments is shown, the distal portion of which includes a magnetically responsive material disposed therein.

[0038] Figure 3 A transverse cross-section of the distal portion of an elongated medical device according to some embodiments is shown, the distal portion of which includes a coating of magnetically responsive material.

[0039] Figure 4A transverse cross-section of the distal portion of an elongated medical device according to some embodiments is shown, the distal portion of which includes another coating in which a magnetically responsive material is disposed.

[0040] Figure 5 A transverse cross-section of the distal portion of an elongated medical device according to some embodiments is shown, the distal portion of the elongated medical device including a further coating of a magnetically responsive material in which one or more therapeutic agents are disposed.

[0041] Figure 6 A transverse cross-section of the distal portion of an elongated medical device according to some embodiments is shown, the distal portion of the elongated medical device including a further coating in which a magnetically responsive material and one or more therapeutic agents are disposed.

[0042] Figure 7 The console and magnetic field generator of a dedicated magnetic field generation system for forming a therapeutic system according to some embodiments are shown.

[0043] Figure 8 An ultrasound console and ultrasound detector, comprising a magnetic field generation subsystem as part of a treatment system, are shown according to some embodiments.

[0044] Figure 9 Block diagrams of an ultrasound console and an ultrasound detector according to some implementation schemes are shown.

[0045] Figure 10 A magnetic field generator is shown as used on a CVC (cervical ventricular occlusion) as an elongated medical device according to some embodiments, wherein the CVC has thrombotic or non-thrombotic occlusion.

[0046] Figure 11 Detailed views of a magnetic field generator used on a CVC with thrombotic or non-thrombotic occlusion, according to some embodiments, are shown.

[0047] Figure 12 A first mechanism for disrupting thrombotic or non-thrombotic occlusions according to some implementation schemes is shown.

[0048] Figure 13 A second mechanism for disrupting thrombotic or non-thrombotic occlusions is shown according to some implementation schemes.

[0049] Figure 14 A magnetic field generator for use on a CVC or PICC is shown according to some embodiments, wherein the accompanying device is an elongated medical device disposed therein, the CVC or PICC having thrombotic or non-thrombotic occlusion.

[0050] Figure 15Detailed views of an accessory device arranged in a CVC or PICC according to some embodiments are shown, the accessory device including an inflatable distal portion that is inflated to contact a thrombotic or non-thrombotic occlusion.

[0051] Figure 16 Detailed views of an accessory device arranged in a CVC or PICC according to some embodiments are shown. The accessory device includes a maneuverable distal portion that is manipulated to contact a thrombotic or non-thrombotic occlusion.

[0052] Figure 17 Detailed views of the distal portion of an elongated medical device according to some embodiments are shown. The distal portion of the elongated medical device includes multiple magnetically responsive structures incorporated into the distal lumen surface of the elongated medical device.

[0053] Figure 18 Detailed views of the cantilever of the magnetic response structure in several magnetic response structures according to some embodiments are shown.

[0054] Figure 19 Detailed views of the distal portion of an elongated medical device according to some embodiments are shown. The distal portion of the elongated medical device includes multiple additional magnetically responsive structures incorporated into the distal lumen surface of the elongated medical device.

[0055] Figure 20 Detailed views of the cylinders of the magnetic response structures in several magnetic response structures according to some embodiments are shown.

[0056] Figure 21 Various thrombotic occlusions that can be medically treated by therapeutic systems and methods for medical treatment according to some embodiments are shown. Detailed Implementation

[0057] Before disclosing some specific embodiments in more detail, it should be understood that the specific embodiments disclosed herein do not limit the scope of the concepts provided herein. It should also be understood that the specific embodiments disclosed herein may have features that can be easily separated from the specific embodiments, and these features may optionally be combined with or replace features of any of the many other embodiments disclosed herein.

[0058] Regarding the terminology used herein, it should be understood that these terms are for the purpose of describing certain specific embodiments and do not limit the scope of the concepts presented herein. Ordinal numbers (e.g., first, second, third, etc.) are generally used to distinguish or identify different features or steps within a set of features or steps and do not provide for a sequence or numerical limitation. For example, the features or steps “first,” “second,” and “third” do not necessarily appear in that order, and a particular embodiment including such features or steps is not necessarily limited to these three features or steps. Furthermore, unless otherwise specified, any of the foregoing features or steps may further include one or more features or steps. For convenience, labels such as “left,” “right,” “top,” “bottom,” “front,” “back,” etc., are used, and these labels are not intended to imply, for example, any particular fixed position, orientation, or direction. Rather, such labels are used to reflect, for example, relative position, orientation, or direction. The singular forms “a,” “an,” and “the” include plural references unless the context clearly specifies otherwise.

[0059] The term "proximal" is used to indicate a portion, segment, component, element, etc., of a medical device intended to be placed near or relatively close to a clinician when used on a patient. For example, a "proximal portion" or "proximal segment" of a medical device includes the portion or segment of the medical device intended to be placed near a clinician when used on a patient. Similarly, a "proximal length" of a medical device includes the length of the medical device intended to be placed near a clinician when used on a patient. A "proximal end" of a medical device includes the end of the medical device intended to be placed near a clinician when used on a patient. The proximal portion, proximal segment, or proximal length of a medical device does not necessarily include the proximal end of the medical device. In practice, the proximal portion, proximal segment, or proximal length of a medical device may be shorter than the proximal end of the medical device. However, the proximal portion, proximal segment, or proximal length of a medical device may include the proximal end of the medical device. If the context does not specify that the proximal portion, proximal segment, or proximal length of a medical device includes the proximal end of the medical device, or if it is deemed advantageous in the following description, the terms "proximal portion," "proximal segment," or "proximal length" may be modified to indicate that such portion, segment, or length includes the end portion, end segment, or end length of the medical device, respectively, to refer to the "proximal portion," "proximal segment," or "proximal length" of the medical device.

[0060] The term "distal" is used to indicate a portion, segment, part, element, etc., of a medical device intended to be placed near, relatively close to, or even inside the patient when used on a patient. For example, a "distal portion" or "distal segment" of a medical device includes a portion or segment of the medical device intended to be placed near, relatively close to, or even inside the patient when used on a patient. Similarly, a "distal length" of a medical device includes the length of the medical device intended to be placed near, relatively close to, or even inside the patient when used on a patient. The "distal end" of a medical device is the end of the medical device intended to be placed near, relatively close to, or even inside the patient when used on a patient. A distal portion, distal segment, or distal length of a medical device does not necessarily include the distal end of the medical device. In practice, a distal portion, distal segment, or distal length of a medical device may be shorter than the distal end of the medical device. However, a distal portion, distal segment, or distal length of a medical device may include the distal end of the medical device. If the context does not specify that the distal portion, distal segment, or distal length of a medical device includes the distal end of the medical device, or if it is deemed advantageous in the following description, the terms “distal portion,” “distal segment,” or “distal length” may be modified to indicate that such a portion, segment, or length includes the end portion, end segment, or end length of the medical device, respectively, to refer to the “distal portion,” “distal segment,” or “distal length” of the medical device.

[0061] Unless otherwise defined, all technical and scientific terms used herein have the same meaning as commonly understood by one of ordinary skill in the art.

[0062] As mentioned above, occlusion in catheters (such as CVCs or PICCs) can inhibit or even prevent fluid flow through such catheters. This can lead to ineffective drug-based treatments and complications such as infiltration, phlebitis, or infection. The aforementioned occlusion can occur in a variety of different ways. In one example, such as... Figure 21 As shown, thrombotic occlusion can occur when one or more thrombi form within, around, or at the distal portion of the catheter. In another example, nonthrombotic occlusion can occur due to biofilm formation during CRBSI, lipid residues from lipid-containing nutrient mixtures or drug formulations including oily carriers, or drug precipitation from the same or different drug formulations within, around, or at the distal portion of the catheter. Existing solutions for medical treatment of thrombotic or nonthrombotic occlusion include antithrombotic or antimicrobial catheter coatings, antithrombotic or antimicrobial catheter sealing solutions, and the application of ultrasonic mechanical vibration; however, such existing solutions have limitations in their efficacy, particularly when antimicrobial resistant bacteria are involved.

[0063] In light of the foregoing, this paper discloses therapeutic systems and methods for the medical treatment of thrombotic and non-thrombotic occlusions using magnetically responsive materials and structures. In fact, 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, deposited drugs, and various combinations thereof, regardless of whether the thrombotic occlusion, non-thrombotic occlusion, or their various combinations are in a state of minimal deposition, complete obstruction, or any intermediate state. For example, as... Figure 21 As shown, the treatment system and method can provide medical treatment for at least intraluminal thrombus 206, fibrin tail 208, fibrin sheath 210, or mural thrombus 212 in the catheter fitting 114 of the aforementioned catheter when the intravenous catheter 112 or another CVC or PICC is placed in the patient's blood vessel 214.

[0064] Treatment System

[0065] Figure 1 A therapeutic system 100 is shown that uses one or more magnetically responsive materials 102 or structures 104 for medical treatment according to some embodiments.

[0066] As shown in the figure, the treatment system 100 for medical treatment includes an elongated medical device 106 and a magnetic field generator 108, each of which can vary according to different implementations. In fact, as described below, the elongated medical device 106 can be, for example... Figure 2A The intravenous catheter 112 shown may be any other tubular medical device, including stents, urinary catheters (such as Foley catheters), etc. Alternatively, the elongated medical device 106 may be, for example... Figure 14 The accessory device 124 shown is configured for insertion into one or more lumens of an intravenous catheter 112 or another intravenous catheter. One or more magnetically responsive materials 102 or structures 104 of the elongated medical device 106 may also vary depending on the implementation. As further explained below, in some embodiments, a magnetic field generator 108 and a console 110 (such as a dedicated console 154) may form a dedicated magnetic field generation system 156 for the treatment system 100. However, in some other embodiments, the magnetic field generator 108 is integrated into an ultrasound detector 160, and the console 110 may be an ultrasound console 158 configured for both ultrasound imaging and driving the magnetic field generator 108. In such embodiments, the magnetic field generation subsystem of the ultrasound system 162 may be considered part of the treatment system 100.

[0067] Slender medical devices

[0068] Figure 2A , Figure 10 and Figure 11 A slender medical device 106 according to some implementation schemes is shown.

[0069] The elongated medical device 106 may be an intravenous catheter 112, which includes a catheter fitting 114, a catheter bushing 116, one or more extension legs 118, and one or more extension leg fittings 120, which are fluidly connected in the aforementioned order. Although Figure 2A The intravenous catheter 112 includes an unbranched or non-branched catheter liner, a single corresponding extension leg, and a single corresponding extension leg fitting, but the intravenous catheter 112 is not limited thereto. In fact, the intravenous catheter 112 can be multi-lumen, wherein the catheter fitting 114 includes multiple catheter fitting lumens, such as two or three catheter fitting lumens. The catheter liner 116 can correspondingly branch into multiple catheter liner lumens, such as two or three catheter liner lumens respectively in a bifurcation or trifurcation catheter liner. One or more extension legs 118 can be multiple extension legs according to the catheter liner 116 and any of its branching. For example, the multiple extension legs 118 can be a pair or three extension legs, wherein each of the multiple extension legs 118 has an extension leg lumen. Finally, one or more extension leg fittings 120 can be multiple extension leg fittings according to the multiple extension legs 118. Thus, in some embodiments, the multiple extension leg fittings 120 can be a pair or three extension leg fittings.

[0070] Whether the intravenous catheter 112 has a single lumen formed by a fluid connection of a single catheter fitting lumen, a single catheter liner lumen, and a single extension leg lumen, or multiple lumens formed by fluid connections of multiple catheter fitting lumen, multiple catheter liner lumen, and multiple extension leg lumen, the intravenous catheter 112 has at least one first lumen 122 passing through it. Such a first lumen 122 is characterized by extending from a distal portion (such as the distal end of the intravenous catheter 112) to a proximal portion (such as the proximal end of the intravenous catheter 112). Other lumens of the intravenous catheter 112 (such as a second or third lumen of the intravenous catheter 112) may be shorter than the distal end of the intravenous catheter 112, but similar to the first lumen 122, they all extend to the proximal portion (such as the proximal end of the intravenous catheter 112).

[0071] Figures 14 to 16 A slender medical device 106 according to some other embodiments is shown.

[0072] In the alternative to intravenous catheter 112, elongated medical device 106 can be a dedicated accessory 124 for magnetic field generator 108 of treatment system 100, wherein accessory 124 includes an elongated body 125 configured for insertion into one or more lumens of an intravenous catheter (similar to intravenous catheter 112), although without one or more magnetically responsive materials 102 or structures 104 of intravenous catheter 112. For example, accessory 124 can be sized for insertion into the first or distal lumen of an intravenous catheter (such as CVC or PICC), as... Figures 14 to 16 Each figure in the diagram is shown. Furthermore, at least the distal portion of the accessory 124 can be configured as an inflatable portion 126 or a maneuverable portion 128 of the accessory 124 for contacting any exposed side of a thrombotic or non-thrombotic occlusion in one or more lumens of the intravenous catheter 112. In fact, as... Figure 15 As shown, the inflatable portion 126 of the accessory device 124 can be inflated to contact the exposed side of any thrombotic or non-thrombotic occlusion in one or more lumens of the intravenous catheter for use in disrupting the thrombotic or non-thrombotic occlusion according to its medical treatment. Figure 16 As shown, the operable portion 128 of the accessory device 124 can be manipulated to contact the exposed side of any thrombotic or nonthrombotic occlusion in one or more lumens of the intravenous catheter for the purpose of disrupting the thrombotic or nonthrombotic occlusion according to its medical treatment.

[0073] It should be understood that while the accessory device 124 is intended for the medical treatment of thrombotic or non-thrombotic occlusions in an intravenous catheter (similar to intravenous catheter 112, but without one or more of its magnetically responsive materials 102 or structures 104), the accessory device 124 can be used with the intravenous catheter 112 to enhance the medical treatment of any thrombotic or non-thrombotic occlusion. In fact, the distal portion of the accessory device 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 when the distal portion of the intravenous catheter 112 has already contacted the inferior side of the thrombotic or non-thrombotic occlusion. When the magnetic field generated by the magnetic field generator 108 is directed towards the distal portions of both the accessory device 124 and the intravenous catheter 112, the thrombotic or non-thrombotic occlusion can be disrupted from both the exposed and inferior sides to enhance the medical treatment of the thrombotic or non-thrombotic occlusion.

[0074] Similar to the intravenous catheter 112, the accessory device 124 has at least a first lumen 122 extending therethrough. This first lumen 122 is characterized by extending from a distal portion of the accessory device 124 to a proximal portion (such as the proximal end of the accessory device 124). However, unlike the intravenous catheter 112, the first lumen 122 of the accessory device 124 is not used for drug-based treatments, etc., but rather for inflating the inflatable portion 126 of the accessory device 124 or manipulating its manipulatory portion 128. In one example, the first lumen 122 of the accessory device 124 can be configured as an inflatable lumen for inflating its inflatable portion 126 in the distal portion of the accessory device 124, such as... Figure 15 As shown. In another example, the first cavity 122 of the accessory 124 may be configured to have actuating elements (e.g., one or more actuating lines) disposed therein, so as to actuate its operable portion 128 in the distal portion of the accessory 124, as shown. Figure 16 As shown.

[0075] Whether the elongated medical device 106 is an intravenous catheter 112 or an accessory device 124, at least the distal portion of the elongated medical device 106 includes one or more magnetically responsive materials 102 or structures 104. Similarly, such a distal portion of the elongated medical device 106 may include a distal portion of the elongated medical device 106 (such as the distal end of the elongated medical device 106), which includes the distal end of the elongated medical device 106. Since the distal portion of the elongated medical device 106 may include one or more magnetically responsive materials 102 or structures 104, the distal end of the elongated medical device 106 may also include one or more magnetically responsive materials 102 or structures 104. In one example, the distal portion of the intravenous catheter 112 may correspond to the distal end of the intravenous catheter 112 (e.g., a tapered portion of the same or different material as the remainder of the catheter fitting), wherein at least the distal end of the intravenous catheter 112 includes, for example, a tapered portion of the same or different material as the remainder of the catheter fitting. Figure 2A , Figure 2B and Figures 3 to 6 One or more magnetically responsive materials 102 or structures 104 are shown. In another example, the distal portion of the accessory 124 may correspond to the inflatable or operable portion 126 or 128 of the accessory 124, wherein at least the inflatable portion 126 or operable portion 128 of the accessory 124 includes, as shown in the figure, Figure 2A , Figure 2B , Figures 3 to 6 and Figures 14 to 16 One or more magnetically responsive materials 102 or structures 104 are shown.

[0076] Regarding the one or more magnetically responsive materials 102, at least the distal portion of the elongated medical device 106 (such as the distal portion of the elongated medical device 106 (e.g., the distal end of the intravenous catheter 112, the inflatable portion 126 of the accessory 124, the manipulable portion 128 of the accessory 124)) may be formed of, incorporated with, or have contained one or more magnetically responsive materials 102, a coating 130 comprising one or more magnetically responsive materials 102, or some combination thereof, for the application of medical treatment. That is, the elongated medical device 106 may be formed, or entirely comprised of, one or more magnetically responsive materials 102, a coating 130 comprising one or more magnetically responsive materials 102, or some combination thereof, for the application of medical treatment.

[0077] Regarding the at least distal portion of the elongated medical device 106 being formed of or incorporating one or more magnetically responsive materials 102, the at least distal portion or distal portion of the elongated medical device 106 may be formed of or incorporating one or more magnetoelastic materials 132. For example, the at least distal portion or distal portion of the elongated medical device 106 may be incorporating one or more magnetoelastic materials 132, wherein one such magnetoelastic material may comprise elongated Fe atoms arranged longitudinally or embedded in the aforementioned portion of the elongated medical device 106. 40 Ni 38 Mo4B 18 belt, such as Figure 2B The transverse cross-section of the distal portion of the slender medical device 106 is shown.

[0078] When a magnetic field is directed at a portion of the elongated medical device 106 comprising one or more magnetoelastic materials 132 (e.g., distal portion, distal end, or distal end), the one or more magnetoelastic materials 132 respond to the magnetic field generated by the magnetic field generator 108. In practice, a medical treatment is applied to the portion of the elongated medical device 106 comprising one or more magnetoelastic materials 132 for a sufficiently long period of time, the medical treatment comprising actuating the one or more magnetoelastic materials 132 and thereby deforming them to disrupt any thrombotic or non-thrombotic occlusions present in the elongated medical device 106, for example, breaking down or dissolving thrombotic occlusions or breaking down non-thrombotic occlusions formed by bacterial biofilms.

[0079] Regarding the at least distal portion of the elongated medical device 106 comprising a coating 130 of one or more magnetically responsive materials 102, the at least distal portion or distal portion of the elongated medical device 106 may include a coating 130 formed of one or more magnetically responsive submicron materials 134, one or more magnetically responsive micron-sized materials 136, or some combination thereof. Alternatively, the coating 130 may be formed of another coating material 138 (such as a biocompatible polymer), wherein one or more magnetically responsive submicron materials 134, one or more magnetically responsive micron-sized materials 136, or some combination thereof are arranged or otherwise loaded within the coating 130 of the other coating material 138. Such a coating 130 may be further defined as an inner lumen coating 140, a distal inner lumen coating 142, or a combination of an inner lumen coating 140 and a distal inner lumen coating 142, although... Figures 3 to 6 Only combinations of inner lumen coating 140 and distal lumen coating 142 are shown. Unless explicitly mentioned in connection with such a type of coating 130, or otherwise indicated by the context, the term "coating" should be understood to encompass the general category of each of the types of inner lumen coating 140, distal lumen coating 142, and combinations of inner lumen coating 140 and distal lumen coating 142.

[0080] When a magnetic field is directed toward a portion of the elongated medical device 106 to which the coating 130 extends (e.g., distal portion, distal end, or distal end), one or more magnetically responsive materials 102 of the coating 130 respond to the magnetic field generated by the magnetic field generator 108. In practice, while the magnetic field is directed toward the coating 130 of the elongated medical device 106, which includes one or more magnetically responsive materials 102, a medical treatment is applied. This medical treatment is selected from localized cryotherapy, release of some of the materials 102, targeted delivery of one or more therapeutic agents 144, and combinations thereof, to disrupt any thrombotic or non-thrombotic occlusions present in the elongated medical device 106, for example, by breaking down or dissolving thrombotic occlusions or killing and breaking down non-thrombotic occlusions formed by bacterial biofilms.

[0081] It is worth noting that the term "magnetically responsive submicron material" is used herein to refer to a subclass of one or more magnetically responsive materials 102, wherein the size of each discrete entity (e.g., particle) of one or more magnetically responsive submicron materials 134 is readily expressed in nanometers. Similarly, the term "magnetically responsive micrometer-sized material" is used herein to refer to a subclass of one or more magnetically responsive materials 102, wherein the size of each discrete entity (e.g., particle) of one or more magnetically responsive micrometer-sized materials 136 is readily expressed in micrometers or micrometers. Therefore, the scale of one or more magnetically responsive materials 102 can range from nanometers to micrometers. For example, coating 130 may include: nanostructures, such as nanoparticles or nanorods of iron, iron oxide (e.g., magnetite [Fe3O4]), 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 aforementioned nanostructures and microstructures. Additionally or alternatively, one or more magnetically responsive materials 102 may include so-called nanodots or microdots, also ranging from at least nanometers to micrometers. For example, see the following reference, the full text of which is incorporated herein by reference: Zhou, Huaijuan et al. “Magnetically driven micro and nanorobots.” Chemical Reviews 121.8 (2021):4999-5041. Finally, for ease of illustration, the description herein of any embodiment set forth with respect to one or more magnetically responsive submicron materials 134 should be understood to extend to one or more magnetically responsive micron-sized materials 136 for such embodiments. That is, any magnetically responsive submicron material 134 appearing in the claims should be interpreted according to its nanoscale discrete entity (e.g., particles), and any magnetically responsive micron-sized material 136 appearing in the claims should be interpreted according to its micron-sized discrete entity (e.g., particles).

[0082] Figure 3 and Figure 4 A transverse cross-section of the distal portion of an elongated medical device 106 according to some embodiments is shown, the distal portion of the elongated medical device comprising a coating 130 of one or more magnetically responsive materials 102.

[0083] like Figure 3 As shown, coating 130 can be formed of one or more magnetically responsive submicron materials 134, wherein the one or more magnetically responsive submicron materials 134 are deposited on at least the distal portion of the elongated medical device 106. Alternatively, as Figure 4As shown, coating 130 may be formed of another coating material 138 (e.g., a biocompatible polymer), wherein one or more magnetically responsive submicron materials 134 are disposed on or embedded in coating 130 of another coating material 138 on at least the distal portion of elongated medical device 106.

[0084] Figure 12 The first mechanism by which local hypothermia is used to disrupt thrombotic or non-thrombotic occlusions according to some embodiments is illustrated.

[0085] As shown in the figure, the magnetic field generated by the magnetic field generator 108 causes at least Figure 3 and Figure 4 One or more magnetically responsive submicron materials 134 of the coating 130 shown resonate with it. Subsequently, relaxation of the one or more magnetically responsive submicron materials 134 leads to energy loss of the one or more magnetically responsive submicron materials 134, thereby causing lattice vibrations (e.g., via Néel relaxation), and thus causing localized low temperatures in the portion of the elongated medical device 106 to which the coating 130 extends (e.g., distal portion, distal end, or distal end) to disrupt thrombotic or non-thrombotic occlusions in the presence of such occlusions. However, it is noteworthy that the aforementioned localized low temperatures in the elongated medical device 106 can also be caused by Brownian relaxation, which involves the physical rotational relaxation of one or more magnetically responsive submicron materials 134 of the coating 130.

[0086] Figure 5 and Figure 6 An additional transverse section is shown of the distal portion of an elongated medical device 106 according to some embodiments, the distal portion of which includes a coating 130 of one or more magnetically responsive materials 102.

[0087] like Figure 5 As shown, coating 130 can be formed of one or more magnetically responsive submicron materials 134, wherein the one or more magnetically responsive submicron materials 134 are deposited on at least the distal portion of the elongated medical device 106, similar to Figure 3As shown. However, alternatively, one or more therapeutic agents 144 (e.g., thrombolytic agents, such as recombinant tissue plasminogen activators including alteplase, reteplase, or teneplastase; antimicrobial agents or antibiotics, such as ciprofloxacin, vancomycin, gentamicin, daptomycin, azithromycin, or one or more rifamycins; etc.) can be deposited together with one or more magnetically responsive submicron materials 134 on at least the distal portion of the elongated medical device 106 for targeted delivery upon release. In practice, one or more therapeutic agents 144 can be disposed within a coating 130 of one or more magnetically responsive submicron materials 134, or vice versa. Figure 6 As shown, coating 130 can be formed from another coating material 138 (e.g., a biocompatible polymer), wherein one or more magnetically responsive submicron materials 134 are disposed on or embedded in coating 130 of the other coating material 138 on at least the distal portion of elongated medical device 106, similar to Figure 4 As shown. However, alternatively, one or more therapeutic agents 144 may be arranged or embedded in a coating 130 of another coating material 138 on at least the distal portion of the elongated medical device 106, together with one or more magnetically responsive submicron materials 134, for targeted delivery upon release.

[0088] Despite the foregoing description, it should be understood that one or more therapeutic agents 144 (e.g., reactive oxygen species [“ROS”], such as hydroxyl radicals) can be generated from one or more magnetically responsive submicron materials 134, as described in the following reference, the entire text of which is incorporated herein by reference: 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, coating 130 is formed of one or more magnetically responsive submicron materials 134 deposited on at least the distal portion of an elongated medical device 106, such as... Figure 3 As shown, or coating 130 is formed of another coating material 138 (e.g., a biocompatible polymer), wherein one or more magnetically responsive submicron materials 134 are disposed on or embedded in coating 130 of another coating material 138 on at least the distal portion of elongated medical device 106, such as Figure 4 As shown. However, the release of one or more therapeutic agents 144 (which may be ROS) from coating 130 follows the guidelines below. Figure 13The second mechanism described is similar to the first mechanism.

[0089] Figure 13 A second mechanism is illustrated, according to some embodiments, for the release of a therapeutic agent from a coating 130 of one or more magnetically responsive submicron materials 134 to disrupt thrombotic or non-thrombotic occlusions. However, Figure 13 Alternatively, it can be interpreted as illustrating a third mechanism, according to some embodiments, of releasing magnetically responsive material from a coating 130 of one or more magnetically responsive submicron materials 134 to disrupt thrombotic or non-thrombotic occlusions.

[0090] While the magnetic field generated by the magnetic field generator 108 can induce resonance between one or more magnetically responsive submicron materials 134 and therewith, thereby causing lattice vibrations and thus localized low temperatures in the portion of the elongated medical device 106 where the coating 130 extends thereon (e.g., distal portion, distal end, or distal end), the magnetic field generated by the magnetic field generator 108 can additionally or alternatively induce resonance between one or more magnetically responsive submicron materials 134 and therewith, and thus release one or more therapeutic agents 144 from at least the portion of the elongated medical device 106 where the coating 130 extends thereon (e.g., distal portion, distal end, or distal end) to disrupt thrombotic or nonthrombotic occlusions in the presence of such occlusions. Furthermore, according to the above description of... Figure 13 An alternative interpretation is that the magnetic field generated by the magnetic field generator 108 may additionally or alternatively cause one or more magnetically responsive submicron materials 134 to resonate with it, and thus release some of the magnetically responsive submicron materials 134 from at least a portion (e.g., distal portion, distal end, or distal end) of the coating 130 extending thereon in the elongated medical device 106 to disrupt thrombotic or nonthrombotic occlusions in the presence of such occlusions.

[0091] One or more magnetically responsive materials 102 are generally described herein as forming at least the distal portion of an elongated medical device 106, incorporating into at least the distal portion of an elongated medical device 106, forming a coating 130 on at least the distal portion of an elongated medical device 106, etc. However, one or more magnetically responsive materials 102 may alternatively be applied directly or otherwise delivered to an intravenous catheter similar to an intravenous catheter 112 via another elongated medical device, or to the intravenous catheter 112 itself for enhanced medical treatment, to disrupt any thrombotic or non-thrombotic occlusion thereof. Alternatively, one or more therapeutic agents 144 described herein may be administered to any of the aforementioned intravenous catheters together with one or more magnetically responsive materials 102 for disrupting any thrombotic or non-thrombotic occlusion thereof. Advantageously, direct application of one or more magnetically responsive materials 102 to such intravenous catheters expands the range of magnetically responsive materials 102 that can be used to disrupt any thrombotic or non-thrombotic occlusion of the intravenous catheter 112.

[0092] Regarding the expansion of the scope of one or more magnetically responsive materials 102 by directly applying one or more magnetically responsive materials 102 to intravenous catheters, the scope of one or more magnetically responsive materials 102 can be expanded to, for example, shape-transformation magnetically responsive materials, such as gallium-based liquid metals, as described in the following reference, the entire text of which is incorporated herein by reference: Elbourne, Aaron et al. “Antibacterial liquid metals: biofilm treatment via magnetic activation.” ACS nano 14.1 (2020): 802-817. It is noteworthy that when the aforementioned gallium-based liquid metal is exposed to or held in a magnetic field (similar to the magnetic field of the magnetic field generator 108) for a sufficiently long period, discrete entities of the gallium-based liquid metal (e.g., droplets) are actuated and transform their shape to form sharp edges, which break up thrombotic or non-thrombotic occlusions, particularly biofilm-formed occlusions, by utilizing the sharp edges to rupture bacterial cell walls. Advantageously, the ultrasound detector 160 can be configured to locally disperse and optionally emulsify the gallium-based liquid metal by ultrasonic cavitation when it is present as clumps in the distal portion of any of the aforementioned intravenous catheters. Not only can the application of ultrasound itself break up and thus disrupt thrombotic or non-thrombotic occlusions in the intravenous catheter, but the dispersion of the gallium-based liquid metal by ultrasonic cavitation ensures the presence of a sufficient number of discrete entities (e.g., droplets) of the gallium-based liquid metal for timely disruption of any thrombotic or non-thrombotic occlusions in the intravenous catheter.

[0093] Figure 17 and Figure 19A detailed view of the distal portion of an elongated medical device 106 according to some embodiments is shown. The distal portion of the elongated medical device includes a plurality of different magnetically responsive structures 104 incorporated into the distal lumen surface 148 of the elongated medical device 106.

[0094] Regarding one or more magnetically responsive structures 104, at least a distal portion of the elongated medical device 106 (such as the distal portion of the elongated medical device 106 (e.g., the distal end of the intravenous catheter 112, the inflatable portion 126 of the accessory 124, the manipulable portion 128 of the accessory 124) may include one or more magnetically responsive structures 104 for administering medical treatment. That is, the elongated medical device 106 may include, or be entirely, one or more magnetically responsive structures 104 for administering medical treatment. Furthermore, the elongated medical device 106 may include multiple magnetically responsive structures 104 thereon, for example, incorporated into the lumen surface 146, the distal lumen surface 148, or both the lumen surface 146 and the distal lumen surface 148 of the elongated medical device 106.

[0095] When a magnetic field is directed at a portion of the elongated medical device 106 comprising a plurality of magnetically responsive structures 104 (e.g., a distal portion, a distal end, or a distal region), the plurality of magnetically responsive structures 104 respond to the magnetic field generated by the magnetic field generator 108. In practice, a medical treatment is applied to the portion of the elongated medical device 106 comprising the plurality of magnetically responsive structures 104 for a sufficiently long period of time, the medical treatment comprising actuating the plurality of magnetically responsive structures 104 to disrupt any thrombotic or non-thrombotic occlusions present in the elongated medical device 106, for example, breaking down or dissolving thrombotic occlusions or breaking down non-thrombotic occlusions formed by bacterial biofilms.

[0096] Figure 18 A detailed view of the cantilever 150 of a magnetic response structure in one of a plurality of magnetic response structures 104 according to some embodiments is shown.

[0097] As shown in the figure, the multiple magnetically responsive structures 104 may include multiple magnetically responsive microstructures, such as multiple cantilever 150, as described in the following reference, the entire text of which is incorporated herein by reference: Leulmi Pichot, Selma et al. “Magneto-mechanically actuated microstructures to efficiently prevent bacterial biofilm formation.” Scientific Reports 10.1 (2020): 15470. However, instead of fabricating the multiple cantilever 150 on a basic silicon substrate, the multiple cantilever 150 may be fabricated on a silicone or another biocompatible polymer of the elongated medical device 106, or, for example, transferred thereon by soft etching. It is noteworthy that there is a spacing between the free ends of the cantilever 150, which optimizes the effectiveness of disrupting thrombotic or non-thrombotic occlusions by utilizing the maneuverability of the cantilever 150. When the cantilever 150 is too close to each other, the maneuverability may be affected by the flexibility of the elongated medical device 106. For example, bending in the elongated medical device 106 can cause tension on one side of the elongated medical device 106 and compression on its opposite side, and the compression causes the cantilever 150s on the opposite sides of the elongated medical device 106 to come closer to each other. The spacing between the free ends of the cantilever 150 takes into account such compression in order to achieve optimized efficacy in disrupting thrombotic or non-thrombotic occlusions by utilizing the operability of the cantilever 150.

[0098] While the magnetic field of the magnetic field generator 108 is directed at a portion of the elongated medical device 106 comprising a plurality of cantilever 150 for a sufficiently long period of time, a medical treatment is applied. This medical treatment includes actuating the plurality of cantilever 150, thereby deflecting each operable cantilever 150 at its free end toward or away from the inner lumen surface 146 or distal lumen surface 148 of the elongated medical device 106. Notably, such deflection can be based on or resonate with the frequency of the alternating magnetic field. In some embodiments, the frequency of the alternating magnetic field 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. For at least bacterial biofilms (such as those that can form during CRBSI), the deflection of the multiple cantilevers 150 at such a frequency over a period of time prevents significant bacterial adhesion to the inner lumen surface 146 or distal lumen surface 148 of the elongated medical device 106, thereby preventing subsequent bacterial growth into a biofilm. Therefore, the multiple cantilevers 150 can advantageously mitigate antimicrobial resistant infections, eliminate their biofilms, or even prevent them preventively in the first place.

[0099] Figure 20A detailed view of the column 152 of the magnetic response structure in one of a plurality of magnetic response structures 104 according to some embodiments is shown.

[0100] As described above, the plurality of magnetically responsive structures 104 may comprise a plurality of magnetically responsive microstructures; however, as shown, the plurality of magnetically responsive microstructures may comprise a plurality of pillars 152, as described in the following reference, the entire text of which is incorporated herein by reference: Gu, Huan et al. “Magnetically driven active topography for long-term biofilm control.” Nature Communications 11.1 (2020): 2211. It is noteworthy that, according to the foregoing reference, a plurality of pillars 152 may be fabricated on silicone or another biocompatible polymer of the elongated medical device 106; however, the spacing between the pillars 152 should be optimized, as described above, to utilize the maneuverability of the pillars 152 to achieve the effect of disrupting thrombotic or non-thrombotic occlusions. When the pillars 152 are too close to each other, maneuverability may be affected by the flexibility of the elongated medical device 106. For example, bending in the elongated medical device 106 can cause tension on one side of the elongated medical device 106 and compression on its opposite side, and the compression causes the columns 152 on the opposite sides of the elongated medical device 106 to move closer to each other. The spacing between the columns 152 takes into account such compression in order to achieve optimized efficacy in disrupting thrombotic or non-thrombotic occlusions by utilizing the operability of the columns 152.

[0101] A medical treatment is applied while the magnetic field of the magnetic field generator 108 is directed at a portion of the elongated medical device 106 comprising a plurality of columns 152 for a sufficiently long period of time. This medical treatment includes actuating the plurality of columns 152, thereby causing each operable column 152 to oscillate on the inner lumen surface 146 or distal lumen surface 148 of the elongated medical device 106. Notably, such oscillation can be based on or resonate with the 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. For at least bacterial biofilms (such as those that can form during CRBSI), the oscillation of the plurality of columns 152 at such frequencies for a period of time prevents significant bacterial adhesion to the inner lumen surface 146 or distal lumen surface 148 of the elongated medical device 106, thereby preventing subsequent bacterial growth into a biofilm. Therefore, multiple columns 152 can advantageously mitigate antimicrobial resistant infections, eliminate their biofilms, or even prevent them preventively in the first place.

[0102] Magnetic field generating system or subsystem

[0103] Figure 7 A dedicated console 154 and a magnetic field generator 108 of a dedicated magnetic field generation system 156 for a therapeutic system 100 according to some embodiments are shown. Figure 8 An ultrasound console 158 and an ultrasound detector 160, comprising a magnetic field generating subsystem as part of a treatment system 100, are shown according to some embodiments.

[0104] As shown in the figure, the console 110 of the treatment system 100 may be a dedicated console 154 configured to drive a magnetic field generator 108 operatively coupled thereto, wherein the dedicated console 154 and the magnetic field generator 108 form a dedicated magnetic field generation system 156 of the treatment system 100. Alternatively, the console 110 of the treatment system 100 may be an ultrasound console 158. Furthermore, the magnetic field generator 108 may be integrated into an ultrasound detector 160 operatively coupled to the ultrasound console 158, wherein the ultrasound console 158 is configured to perform ultrasound imaging using the ultrasound detector 160 and to drive its magnetic field generator 108. In such embodiments, the magnetic field generation system of the treatment system 100 is a magnetic field generation subsystem of the ultrasound system 162, wherein the magnetic field generation subsystem of the ultrasound system 162, or the entire ultrasound system 162, can be considered part of the treatment system 100. Advantageously, the magnetic field generation subsystem of ultrasound system 162 provides additional functionality to the ultrasound system, which synergistically allows visualization of thrombotic and non-thrombotic occlusions of intravenous catheters (if present) and the medical treatments described herein for any thrombotic and non-thrombotic occlusions. Furthermore, the additional functionality of the magnetic field generation subsystem is provided to such ultrasound systems that are already familiar to the user. Despite the foregoing, the dedicated console 154 and magnetic field generator 108 can alternatively employ the shape factor of ultrasound system 162 without any ultrasound imaging functionality, allowing the user of the ultrasound system to operate based on shape factor familiarity.

[0105] Figure 9 A block diagram of an ultrasound console 158 and an ultrasound detector 160 according to some embodiments is shown.

[0106] It should be understood that, although the following references Figure 9The block diagram describes the ultrasound system 162, but the magnetic field generating subsystem of the ultrasound system 162 and the dedicated magnetic field generating system 156 of the treatment system 100 share various common components. Therefore, the description of the components of the dedicated console 154 and magnetic field generator 108 of the dedicated magnetic field generating system 156 of the treatment system 100 can be extracted from the description of at least the magnetic field generating subsystem of the ultrasound system 162. For this purpose, the various components of the dedicated console 154 and magnetic field generator 108 of the dedicated magnetic field generating system 156 are identified in the accompanying drawings using the reference numerals used in the description of the ultrasound console 158 of the magnetic field generating subsystem of the ultrasound system 162 and the magnetic field generator 108 of the ultrasound detector 160.

[0107] The ultrasound control console 158 may include one or more processors 164 and a memory 166, the memory including instructions 168 stored thereon, which are 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 performing ultrasound imaging using the ultrasound detector 160, applying medical treatments to disrupt any thrombotic or non-thrombotic occlusion of the intravenous catheter 112 or a similar intravenous catheter with an accessory 124, or both. Regarding ultrasound imaging, some of the various functions may include transmitting emitted ultrasound signals into a patient, receiving echo ultrasound signals from a patient, or processing echo ultrasound signals into ultrasound imaging data to visualize any thrombotic or non-thrombotic occlusion of the intravenous catheter 112 or a similar intravenous catheter, or any of the aforementioned intravenous catheters, with the accessory 124, or both. Regarding applying medical treatments, some of the various functions may include driving a magnetic field generator 108 or actuating one or more magnetically responsive materials 102 or structures 104 of an elongated medical device 106. For example, actuating one or more magnetically responsive materials 102 or structures 104 of an elongated medical device 106 may include actuating one or more magnetoelastic materials 132 thereon, thereby deforming one or more magnetoelastic materials 132 to disrupt any thrombotic or non-thrombotic occlusion; causing one or more magnetically responsive submicron materials 134 to resonate with a magnetic field, thereby causing localized hypothermia; releasing some of the materials in one or more magnetically responsive submicron materials 134; releasing one or more therapeutic agents 144 or some combination thereof to disrupt any thrombotic or non-thrombotic occlusion; or driving multiple magnetically responsive structures 104 to disrupt any thrombotic or non-thrombotic occlusion.

[0108] The ultrasound console 158 may also include a display screen 170 integrated therein; however, the display screen 170 may alternatively be separate from and communicatively coupled to the ultrasound console 158. The display screen 170 may be configured to provide a graphical user interface (“GUI”) and display information thereon, such as ultrasound images of at least one vessel 214 of the patient in which an intravenous catheter 112 or similar intravenous catheter (e.g., CVC, PICC, etc.) is placed, optionally with any thrombotic or non-thrombotic occlusion.

[0109] The ultrasound console 158 may also include a console button interface 172 with one or more physical buttons 174 configured to immediately invoke one or more desired ultrasound system modes on the display screen 170, such as a scan mode for collecting ultrasound imaging data to display ultrasound images on the display screen 170, or a treatment mode for driving the magnetic field generator 108 and actuating one or more magnetically responsive materials 102 or structures 104 of the elongated medical device 106 to disrupt any thrombotic or non-thrombotic occlusions. However, the ultrasound console 158 may additionally or alternatively include one or more on-screen buttons 176 provided by a GUI, such as… Figure 8 As shown.

[0110] The ultrasound console 158 may also include a digital controller / analog interface 178 configured to communicate with one or more processors 164, other components of the ultrasound console 158, and other components of the ultrasound system 162 (such as an array of ultrasound transducers 190 or a magnet of an ultrasound detector 160) to manage the handover between the aforementioned components.

[0111] The ultrasound console 158 may also include a power connection 180 configured to provide an operable connection to an external power supply 182. Additionally or alternatively, the ultrasound console 158 may include an internal power supply 184 (e.g., a battery). Regardless of whether the ultrasound console 158 includes an internal power supply 184, it includes power management circuitry 186 with a digital controller / analog interface 178 for power regulation and distribution. In practice, such power regulation and distribution includes powering the magnetic field generator 108 when generating a magnetic field, which may include using alternating current to generate the magnetic field to achieve an alternating magnetic field, as described below. It is noteworthy that for one hour of use, the power requirement of 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. Depending on the amount, concentration, or both of one or more magnetically responsive materials 102 or structures 104 in at least the distal portion of the elongated medical device 106, such power is sufficient to disrupt any thrombotic or non-thrombotic occlusion at a depth of up to at least 5 cm, 10 cm, or 15 cm in the elongated medical device 106.

[0112] The ultrasound detector 160 may include a detector head 188 that houses an array of ultrasound transducers 190, wherein the array of ultrasound transducers 190 includes piezoelectric transducers or capacitive micromechanical ultrasound transducers (“CMUTs”). Such a detector head 188 of the ultrasound detector 160 is configured to rest against the patient’s skin to transmit ultrasound signals into the patient’s body and receive echo ultrasound signals from the patient.

[0113] The ultrasound detector 160 may include magnets housed together with the array of ultrasound transducers 190 in a detector head 188. For example, the detector head 188 may include one or more magnetic field generating electromagnets 192 for generating a magnetic field, such as a plurality of magnetic field generating electromagnets 192 (e.g., a pair of magnetic field generating electromagnets 192), and in some embodiments, the magnetic field may be an alternating magnetic field. Optionally, the detector head 188 may also include a manipulation magnet 194, which may also be an electromagnet, for manipulating any of one or more manipulating magnetically responsive materials 102, structures 104, etc., such as any free nanoparticles or microparticles (e.g., nanoparticles or microparticles released from coating 130, nanoparticles or microparticles deposited in an intravenous catheter (such as intravenous catheter 112), or some combination thereof). The probe head 188 of the ultrasound probe 160 is further configured to be placed against the patient's skin for actuating one or more magnetically responsive materials 102 or structures 104 of the elongated medical device 106, or manipulating any free nanoparticles or microparticles, such as moving free nanoparticles or microparticles (if present) to bring them into contact with any thrombotic or non-thrombotic occlusion.

[0114] It is worth noting that, relative to the dedicated magnetic field generator 108 of the treatment system 100, but extendable to the magnetic field generator 108 of the ultrasound detector 160, one or more magnetic field generating electromagnets 192 for generating the magnetic field can be arranged in an elliptical shape. Notably, in the special case where the two foci of the ellipse coincide at the geometric center of the ellipse, the ellipse encompasses a circle. This arrangement of one or more magnetic field generating electromagnets 192 facilitates the generation of a single alternating magnetic field for the magnetic field. In one example, the single magnetic field generating electromagnet can have a coil with a diameter similar to... Figure 7 The diameters of the multiple magnetic field generating electromagnets 192 arranged in a circular pattern around the head 196 of the magnetic field generator 108 are symmetrical. A single magnetic field generating electromagnet can be configured to generate a single alternating magnetic field. In another example, Figure 7 The plurality of magnetic field generating electromagnets 192 shown around the head 196 of the magnetic field generator 108 can be configured to generate a single alternating magnetic field by superimposing each magnetic field generated by the plurality of magnetic field generating electromagnets 192.

[0115] The ultrasonic detector 160 may also include a button and memory controller 198 for managing button operations of one or more physical buttons 200 configured to operate the magnetic field generator 108, as well as operating the ultrasonic detector 160 itself. In one example, the one or more physical buttons 200 may include a switch button for turning the magnetic field generating electromagnet 192 on or off. In another example, the one or more physical buttons 200 may include another switch button for turning the manipulating magnet 194 on or off. The button and memory controller 198 is operatively in communication with a detector interface 201 of the ultrasonic console 158, the detector interface including input / output (“I / O”) components 202 for communication with the ultrasonic transducer 190 or the array of magnets, and button and memory I / O components 204 for communication with the button and memory controller 198.

[0116] method

[0117] Figure 10 , Figure 11 and Figure 14 The occlusion disruption operation is illustrated according to some embodiments using the treatment system 100 or the treatment system 100 itself.

[0118] This document also discloses methods for using a treatment system 100 for medical treatment. Such methods include methods that utilize at least the treatment system 100 and methods that utilize the treatment system 100 itself. For example, methods that utilize the treatment system 100 itself may include magnetic field driving operations, magnetic field generation operations, magnetic field response operations, and occlusion destruction operations.

[0119] Magnetic field driving operation may include driving the magnetic field generator 108 using a dedicated console 154 or an ultrasonic console 158 having one or more processors 164 and a memory 166 thereon storing instructions 168, which are used to drive the magnetic field generator 108 when executed by one or more processors 164.

[0120] The magnetic field generation operation may include generating a magnetic field using a magnetic field generator 108.

[0121] Magnetic field responsive operation may include responding to a magnetic field by a distal portion of the elongated medical device 106 to apply a medical treatment. As described above, at least the distal portion of the elongated medical device 106 may include a coating 130 thereon, wherein the coating 130 may include one or more magnetically responsive submicron materials 134 for responding to a magnetic field. Alternatively, at least the distal portion of the elongated medical device 106 may include a plurality of magnetically responsive structures 104 incorporated into the surface of the elongated medical device 106 for responding to a magnetic field. Furthermore, alternatively, at least the distal portion of the elongated medical device 106 may include one or more magnetoelastic materials 132 incorporated into the elongated medical device 106 or forming the entire distal portion of the elongated medical device 106 for responding to a magnetic field.

[0122] Occlusion destruction procedures may include destroying any thrombotic or non-thrombotic occlusion (if present) on the distal portion of the elongated medical device 106 (e.g., intravenous catheter 112) in response to a magnetic field, or destroying any thrombotic or non-thrombotic occlusion (if present) using the distal portion of the elongated medical device 106 (e.g., accessory 124).

[0123] While certain specific embodiments have been disclosed herein, and while these specific embodiments have been disclosed in considerable detail, they are not intended to limit the scope of the concepts provided herein. Other adaptations or modifications will arise in those skilled in the art, and are also encompassed in a broader sense. Therefore, changes may be made to the specific embodiments disclosed herein without departing from the scope of the concepts provided herein.

Claims

1. A therapeutic system using one or more magnetically responsive materials for medical treatment, comprising: Elongated medical device, the elongated medical device comprising: First internal cavity; and A coating selected from an inner lumen coating, a distal inner lumen coating, and a combination of both said inner lumen coating and distal inner lumen coating on at least a distal portion of said elongated medical device, said coating comprising one or more magnetically responsive submicron materials for said one or more magnetically responsive materials; and A magnetic field generator, wherein one or more magnetically responsive submicron materials respond to a magnetic field generated by the magnetic field generator when the magnetic field is directed toward the coating in order to achieve the medical treatment, the medical treatment being selected from local cryotherapy, targeted delivery of one or more therapeutic agents and combinations thereof, to disrupt any thrombotic or non-thrombotic occlusion.

2. The treatment system of claim 1 further includes a console configured to drive the magnetic field generator, the console including one or more processors and a memory storing instructions thereon that drive the magnetic field generator when executed by the one or more processors.

3. The treatment system according to claim 2, wherein the console and the magnetic field generator form a dedicated magnetic field generation system for the treatment system.

4. The treatment 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 detector.

5. The treatment system according to any one of claims 1 to 4, wherein the elongated medical device is an intravenous catheter, and the distal portion of the elongated medical device includes a distal end such that the coating extends over the distal end to disrupt the thrombotic or nonthrombotic occlusion in the presence of the distal end.

6. The treatment system according to any one of claims 1 to 4, wherein the elongated medical device is a dedicated accessory to the magnetic field generator of the treatment system, the accessory being configured for insertion into one or more lumens of an intravenous catheter.

7. The treatment system of claim 6, wherein the distal portion of the elongated medical device includes a distal end such that the coating extends over the distal end to contact and disrupt the thrombotic or nonthrombotic occlusion in the presence of the thrombotic or nonthrombotic occlusion in the lumen of the intravenous catheter.

8. The treatment system of claim 7, wherein the distal portion of the elongated medical device including the coating is inflatable to contact and disrupt the thrombotic or nonthrombotic occlusion in the presence of the thrombotic or nonthrombotic occlusion in the one or more lumens of the intravenous catheter, the first lumen being configured as an inflatable lumen for inflating the distal portion of the elongated medical device.

9. The treatment system of claim 7, wherein the accessory device is steerable to contact and disrupt the thrombotic or non-thrombotic occlusion in the presence of the thrombotic or non-thrombotic occlusion in one or more lumens of the intravenous catheter, the first lumen including a manipulation element disposed therein for manipulating the accessory device.

10. The treatment system according to any one of claims 1 to 9, wherein the coating comprises one or more magnetically responsive submicron materials deposited on at least the distal portion of the elongated medical device.

11. The treatment system according to any one of claims 1 to 9, wherein the coating comprises one or more magnetically responsive submicron materials embedded in a coating material on at least the distal portion of the elongated medical device.

12. The treatment system of claim 10 or 11, wherein the coating comprises one or more magnetically responsive submicron materials and one or more therapeutic agents deposited on or embedded in a coating material on at least the distal portion of the elongated medical device.

13. The treatment system according to any one of claims 1 to 12, wherein the magnetic field generated by the magnetic field generator causes the one or more magnetically responsive submicron materials to resonate therewith, and subsequently, relaxation of the one or more magnetically responsive submicron materials leads to energy loss of the one or more magnetically responsive submicron materials, thereby causing lattice vibrations, thus causing localized low temperatures in at least the distal portion of the elongated medical device, so as to disrupt the thrombotic or non-thrombotic occlusion in the presence of the thrombotic or non-thrombotic occlusion.

14. The treatment system according to any one of claims 1 to 12, wherein the magnetic field generated by the magnetic field generator causes the one or more magnetically responsive submicron materials to resonate with it, thereby releasing the one or more therapeutic agents from at least the distal portion of the elongated medical device to disrupt the thrombotic or nonthrombotic occlusion in the presence of the thrombotic or nonthrombotic occlusion.

15. The treatment system according to any one of claims 1 to 14, wherein each of the thrombotic or non-thrombotic occlusions is selected from intraluminal thrombi, fibrin tails, fibrin sheaths, mural thrombi, biofilms, lipid residues, precipitated drugs, and some combination thereof.

16. A therapeutic system using a magnetically responsive structure for medical treatment, comprising: Elongated medical device, the elongated medical device comprising: First internal cavity; and Multiple magnetically responsive structures are incorporated into an inner lumen surface, a distal inner lumen surface, or a combination of both, on at least a distal portion of the elongated medical device; and A magnetic field generator, wherein one or more magnetically responsive structures respond to a magnetic field generated by the magnetic field generator when the magnetic field is directed toward the distal portion of the elongated medical device in order to perform the medical procedure, the medical procedure comprising actuating the plurality of magnetically responsive structures to disrupt any thrombotic or non-thrombotic occlusion.

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

18. The treatment system of claim 17, wherein the console and the magnetic field generator form a dedicated magnetic field generation system for the treatment system.

19. The treatment 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 detector.

20. The treatment system according to any one of claims 16 to 19, wherein the elongated medical device is an intravenous catheter, and the plurality of magnetically responsive structures are incorporated into the distal portion of the elongated medical device including the distal end of the intravenous catheter to disrupt the thrombotic or non-thrombotic occlusion in the presence of the thrombotic or non-thrombotic occlusion at the distal end.

21. The treatment system according to any one of claims 16 to 20, wherein each of the thrombotic or non-thrombotic occlusions is selected from intraluminal thrombi, fibrin tails, fibrin sheaths, mural thrombi, biofilms, lipid residues, precipitated drugs, and some combination thereof.

22. A treatment system using magnetoelastic materials for medical processing, comprising: An elongated medical device including a first lumen, the elongated medical device including at least a distal portion formed of or incorporated therein by the magnetoelastic material; and A magnetic field generator, wherein the magnetoelastic material responds to a magnetic field generated by the magnetic field generator when the magnetic field is directed toward the distal portion of the elongated medical device in order to perform the medical treatment, the medical treatment including actuating the magnetoelastic material to disrupt any thrombotic or non-thrombotic occlusion.

23. The treatment system according to claim 22, further comprising: A console configured to drive the magnetic field generator, the console including one or more processors and a memory thereon storing instructions that drive the magnetic field generator when executed by the one or more processors.

24. The treatment system of claim 23, wherein the console and the magnetic field generator form a dedicated magnetic field generation system for the treatment system.

25. The treatment 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 detector.

26. The treatment system according to any one of claims 22 to 25, wherein the elongated medical device is an intravenous catheter, and the magnetoelastic material is incorporated into the distal portion of the elongated medical device including the distal end of the intravenous catheter to disrupt the thrombotic or non-thrombotic occlusion in the presence of the thrombotic or non-thrombotic occlusion at the distal end.

27. The treatment system according to any one of claims 22 to 26, wherein each of the thrombotic or non-thrombotic occlusions is selected from intraluminal thrombi, fibrin tails, fibrin sheaths, mural thrombi, biofilms, lipid residues, precipitated drugs, and some combination thereof.

28. A method for a treatment system for medical treatment, comprising: A magnetic field is generated using a magnetic field generator; as well as The medical treatment is performed by a distal portion of an elongated medical device that responds to the magnetic field, wherein at least the distal portion of the elongated medical device comprises: A coating, located on the distal portion of the elongated medical device, comprising one or more magnetically responsive submicron materials for responding to the magnetic field; Multiple magnetically responsive structures, incorporated into the surface of the distal portion of the elongated medical device, are used to respond to the magnetic field; or A magnetoelastic material, incorporated into or integrally forming the distal portion of the elongated medical device, for responding to the magnetic field; and When the distal portion of the elongated medical device responds to the magnetic field, it disrupts any thrombotic or non-thrombotic occlusion present in the distal portion of the elongated medical device.

29. The method of claim 28, further comprising driving the magnetic field generator using a console, the console including one or more processors and a memory storing instructions thereon, the instructions being used to drive the magnetic field generator when executed by the one or more processors.

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