Catheter assembly

Abstract

A catheter assembly may include a catheter, a controller, and an internal power source. The catheter may include a catheter tube and a catheter hub, wherein a proximal end portion of the catheter tube may be disposed in the catheter hub. The catheter tubing may incorporate a plurality of piezoelectric transducers into the length of the catheter tubing. The plurality of piezoelectric transducers may be configured as a plurality of vibrators for vibrating when the catheter tube is placed in the vasculature and thereby inhibiting accumulation of biological material on a lumenal surface or a distal lumenal surface of the catheter tube by means of vibration along a length of the catheter tube. The controller may include a processor and a memory, wherein the controller may be configured to control the at least multiple piezoelectric transducers. The internal power source may be configured to power the controller and the plurality of piezoelectric transducers.

Description

[0001] priority

[0002] This application claims the benefit of priority to U.S. Provisional Application No. 63 / 471,744, filed on June 7, 2023, which is incorporated by reference in its entirety into this application. Technical Field

[0003] The present invention relates to the field of medical devices, and more particularly to catheter assemblies. Background Art

[0004] Occlusions in catheters, including central venous catheters ("CVCs") and peripherally inserted central catheters ("PICCs"), can inhibit or even prevent fluid flow through such catheters. This can lead to ineffective medications and complications such as infiltration, phlebitis, or infection. The aforementioned occlusions can occur in a variety of different ways. In one example, Figure 8 As shown, thrombotic occlusions can occur when one or more thrombi are formed in, around, or at the distal portion of the catheter. In another example, non-thrombotic occlusions can occur due to biofilm formation, lipid residues from a lipid-containing nutrient mixture or a drug formulation including an oily carrier, or drug precipitation from the same or different drug formulation in, around, or at the distal portion of the catheter. Catheters, catheter assemblies, and methods for inhibiting the formation of such occlusions are needed. Disclosed herein are catheters, catheter assemblies, and methods that solve the aforementioned problems by mechanically inhibiting the formation of such occlusions. Summary of the invention

[0005] In some embodiments, a catheter assembly is disclosed herein, comprising a catheter, a controller, and an internal power source. The catheter comprises a catheter tube and a catheter sleeve, and the proximal portion of the catheter tube is arranged in the catheter sleeve. The catheter tube incorporates multiple piezoelectric transducers into the length of the catheter tube. The multiple piezoelectric transducers are configured as multiple vibrators for vibrating when the catheter tube is placed in the vascular system and thereby inhibiting the accumulation of biomaterials on the luminal surface of the catheter tube, the distal luminal surface of the catheter tube, or the luminal surface and the distal luminal surface of the catheter tube by means of vibration along the length of the catheter tube. The controller comprises a processor and a memory, and the controller is configured to control at least a plurality of piezoelectric transducers. The internal power source is configured to power the controller and the multiple piezoelectric transducers.

[0006] In some embodiments, the plurality of piezoelectric transducers and the electrical leads connecting the plurality of piezoelectric transducers to the controller are flexible electronic devices. The flexible electronic devices are fabricated on the luminal surface of the catheter tube, fabricated on the distal luminal surface of the catheter tube, or disposed between the luminal surface and the distal luminal surface of the catheter tube.

[0007] In some embodiments, the internal power source is a lithium-ion battery or a flexible battery.

[0008] In some embodiments, the thickness of the flexible electronic device ranges from about 1 μm to about 500 μm.

[0009] In some embodiments, individual piezoelectric transducers in the plurality of piezoelectric transducers, individual groups of piezoelectric transducers in the plurality of piezoelectric transducers, or a combination of individual piezoelectric transducers and individual groups of piezoelectric transducers are individually electronically addressed.

[0010] In some embodiments, individual piezoelectric transducers, individual groups of piezoelectric transducers, or combinations of individual piezoelectric transducers and individual groups of piezoelectric transducers are individually electronically addressable allowing the vibrations along the length of the catheter tubing to be customized by the position of individual piezoelectric transducers or individual groups of piezoelectric transducers.

[0011] In some embodiments, individual piezoelectric transducers, individual groups of piezoelectric transducers, or a combination of individual piezoelectric transducers and individual groups of piezoelectric transducers are individually electronically addressed to allow the distal portion of the catheter tubing to be cut to achieve the desired placement length of the catheter tubing. The remaining piezoelectric transducers of the plurality of piezoelectric transducers that are not cut with the distal portion of the catheter tubing are capable of vibrating along the placement length of the catheter tubing in accordance with being individually electronically addressed.

[0012] In some embodiments, the plurality of piezoelectric transducers are further configured as a plurality of sensors for sensing and thereby monitoring environmental conditions of the catheter tube when the catheter tube is placed in the vasculature.

[0013] In some embodiments, the controller and internal power source are incorporated into a portion of the catheter hub. Optionally, the controller and internal power source are incorporated into the sewing wings of the catheter hub.

[0014] In some embodiments, the controller and internal power source are incorporated into a base or cover of the catheter fixture. The base or cover of the catheter fixture includes fixture-based electrical connectors for connecting to catheter-based electrical connectors to power and control the plurality of piezoelectric transducers.

[0015] In some embodiments, the controller is configured to vibrate the plurality of piezoelectric transducers at a frequency in a range of about 30 Hz to about 15 MHz and an amplitude in a range of about 1 nm to about 100 μm.

[0016] In some embodiments, the accumulation of biological material is an intraluminal thrombus, a fibrin tail, a fibrin sheath, a mural thrombus, a biofilm, or a combination thereof.

[0017] In some embodiments, the catheter is a CVC or a PICC.

[0018] In some embodiments, a method of a catheter assembly is also disclosed herein, which includes a placement operation and a power supply operation. The placement operation includes placing a catheter of the catheter assembly in the patient's vascular system. The catheter includes a catheter tube and a catheter hub, and the proximal portion of the catheter tube is arranged in the catheter hub. The catheter tube incorporates multiple piezoelectric transducers into the length of the catheter tube. Multiple piezoelectric transducers are configured as multiple vibrators. The power supply operation includes powering the catheter assembly with the aid of an internal power supply. The power supply operation activates a controller including a processor and a memory, and the controller is configured to control multiple piezoelectric transducers to vibrate and thereby inhibit the accumulation of biomaterials on the inner cavity surface of the catheter tube, the far inner cavity surface of the catheter tube, or the inner cavity surface and the far inner cavity surface of the catheter tube by means of vibration along the length of the catheter tube.

[0019] In some embodiments, the plurality of piezoelectric transducers and the electrical leads connecting the plurality of piezoelectric transducers to the controller are flexible electronic devices. The flexible electronic devices are fabricated on the luminal surface of the catheter tube, fabricated on the distal luminal surface of the catheter tube, or disposed between the luminal surface and the distal luminal surface of the catheter tube.

[0020] In some embodiments, individual piezoelectric transducers in the plurality of piezoelectric transducers, individual groups of piezoelectric transducers in the plurality of piezoelectric transducers, or a combination of individual piezoelectric transducers and individual groups of piezoelectric transducers are individually electronically addressed.

[0021] In some embodiments, individual piezoelectric transducers, individual groups of piezoelectric transducers, or combinations of individual piezoelectric transducers and individual groups of piezoelectric transducers are individually electronically addressable allowing the vibrations along the length of the catheter tubing to be customized by the position of individual piezoelectric transducers or individual groups of piezoelectric transducers.

[0022] In some embodiments, the method further comprises a cutting operation prior to a placement operation for placing the catheter in the patient's vascular system. The cutting operation comprises cutting a distal portion of the catheter tubing to achieve a desired placement length of the catheter tubing. Individual piezoelectric transducers, individual groups of piezoelectric transducers, or a combination of individual piezoelectric transducers and individual groups of piezoelectric transducers are individually electronically addressed to allow the remaining piezoelectric transducers of the plurality of piezoelectric transducers that are not cut with the distal portion of the catheter tubing to vibrate along the placement length of the catheter tubing according to being individually electronically addressed after a powering operation for powering the catheter assembly.

[0023] In some embodiments, the plurality of piezoelectric transducers are further configured as a plurality of sensors for sensing and thereby monitoring environmental conditions of the catheter tube during placement operations of placing the catheter in the patient's vasculature and powering operations of powering the catheter assembly and activating the controller.

[0024] In some embodiments, the controller and internal power source are incorporated into a portion of the catheter hub. Optionally, the controller and internal power source are incorporated into the sewing wings of the catheter hub.

[0025] In some embodiments, the accumulation of biological material is an intraluminal thrombus, a fibrin tail, a fibrin sheath, a mural thrombus, a biofilm, or a combination thereof.

[0026] These and other features of the concepts provided herein will become more readily apparent to those skilled in the art in view of the accompanying drawings and the following description, which describe in more detail specific embodiments of such concepts. BRIEF DESCRIPTION OF THE DRAWINGS

[0027] Figure 1 A catheter for mechanically inhibiting occlusion formation is shown in accordance with some embodiments.

[0028] Figure 2 Shown is a detailed view of a catheter tube of a catheter according to some embodiments, the catheter tube including a plurality of piezoelectric transducers along the length of the catheter tube.

[0029] Figure 3 Shown is a detailed view of a catheter hub of a catheter according to some embodiments, the catheter hub including a controller and an internal power source incorporated into a portion of the catheter hub.

[0030] Figure 4 Another catheter for mechanically inhibiting occlusion formation is shown in accordance with some embodiments.

[0031] Figure 5 According to some embodiments, a Figure 4Detailed view of a baseboard of a catheter fixture device for a catheter of FIG. 1 , the catheter fixture device including a controller and an internal power supply incorporated into the baseboard.

[0032] Figure 6 According to some embodiments, the fixing Figure 5 Catheter fixation devices in Figure 4 A catheter is provided to form a catheter assembly for mechanically inhibiting occlusion formation.

[0033] Figure 7 According to some embodiments, Figure 1 catheter or Figure 6 Block diagram of the catheter assembly.

[0034] Figure 8 Various thrombotic occlusions are shown according to some embodiments. DETAILED DESCRIPTION

[0035] 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 be optionally combined with or replace the features of any of the many other embodiments disclosed herein.

[0036] About the terms used herein, it should also be understood that these terms are for the purpose of describing some specific embodiments, and these 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 set of features or steps, and do not provide sequence or numerical restrictions. For example, "first", "second" and "third" features or steps do not necessarily appear in this order, and the specific embodiments including such features or steps are not necessarily limited to these three features or steps. In addition, unless otherwise specified, any feature or step in the aforementioned features or steps and then can also include one or more features or steps. For convenience, using labels such as "left", "right", "top", "bottom", "front", "back", etc., these labels are not intended to imply, for example, any specific fixed position, orientation or direction. On the contrary, such labels are used to reflect, for example, relative position, orientation or direction. The singular forms of "a kind of", "one" and "the" include plural references, unless the context clearly specifies otherwise.

[0037] "Proximal" is used to indicate a portion, segment, component, element, etc. of a medical device that is intended to be placed near or relatively close to a clinician when the medical device is used on a patient. For example, a "proximal portion" or "proximal segment" of a medical device includes a portion or segment of a medical device that is intended to be placed near a clinician when the medical device is used on a patient. Similarly, a "proximal length" of a medical device includes a length of a medical device that is intended to be placed near a clinician when the medical device is used on a patient. The "proximal end" of a medical device includes an end of a medical device that is intended to be placed near a clinician when the medical device is used on a patient. The proximal portion, proximal segment, or proximal length of a medical device need not include the proximal end of the medical device. In fact, 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 indicate that the proximal portion, proximal segment, or proximal length of a medical device includes the proximal end of the medical device, or if deemed advantageous in the following description, the "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, respectively, of the medical device to refer to the "proximal portion," "proximal segment," or "proximal length" of the medical device.

[0038] "Distal" is used to indicate that the part, segment, component, element, etc. of the medical device is intended to be placed near the patient, relatively close to the patient, or even in the patient's body when the medical device is used for the patient. For example, the "distal part" or "distal segment" of the medical device includes the part or segment of the medical device intended to be placed near the patient, relatively close to the patient, or even in the patient's body when the medical device is used for the patient. Similarly, the "distal length" of the medical device includes the length of the medical device intended to be placed near the patient, relatively close to the patient, or even in the patient's body when the medical device is used for the patient. The "distal end" of the medical device is the end of the medical device intended to be placed near the patient, relatively close to the patient, or even in the patient's body when the medical device is used for the patient. The distal part, distal segment, or distal length of the medical device does not need to include the distal end of the medical device. In fact, the distal part, distal segment, or distal length of the medical device can be shorter than the distal end of the medical device. However, the distal part, distal segment, or distal length of the medical device can include the distal end of the medical device. If the context does not indicate that the distal portion, distal segment, or distal length of a medical device includes the distal end of the medical device, or if deemed advantageous in the following description, the "distal portion," "distal segment," or "distal length" may be modified to indicate that such portion, segment, or length includes the end portion, end segment, or end length, respectively, of the medical device to refer to the "distal portion," "distal segment," or "distal length" of the medical device.

[0039] Unless defined otherwise, all technical and scientific terms used herein have the same meanings as commonly understood by one of ordinary skill in the art.

[0040] Occlusions in catheters (including CVCs and PICCs) can inhibit or even prevent fluid flow through such catheters. This can lead to ineffective medications and complications such as infiltration, phlebitis, or infection. The aforementioned occlusions can occur in a variety of different ways. In one example, Figure 8 As shown, thrombotic occlusions can occur when one or more thrombi are formed in, around, or at the distal portion of the catheter. In another example, non-thrombotic occlusions can occur due to biofilm formation, lipid residues from a lipid-containing nutrient mixture or a drug formulation including an oily carrier, or drug precipitation from the same or different drug formulation in, around, or at the distal portion of the catheter. Catheters, catheter assemblies, and methods for inhibiting the formation of such occlusions are needed. Disclosed herein are catheters, catheter assemblies, and methods that solve the aforementioned problems by mechanically inhibiting the formation of such occlusions.

[0041] For example, the catheter assembly may include a catheter, a controller, and an internal power supply. The catheter may include a catheter tube and a catheter sleeve, wherein the proximal portion of the catheter tube may be arranged in the catheter sleeve. The catheter tube may incorporate multiple piezoelectric transducers into the length of the catheter tube. Multiple piezoelectric transducers may be configured as multiple vibrators for vibrating when the catheter tube is placed in the vascular system and thereby suppressing the accumulation of biomaterials on the inner cavity surface or the far inner cavity surface of the catheter tube by means of vibration along the length of the catheter tube. The controller may include a processor and a memory, wherein the controller may be configured to control at least a plurality of piezoelectric transducers. The internal power supply may be configured to power the controller and a plurality of piezoelectric transducers. In view of the accompanying drawings and the following description, such catheter assemblies and their features will become more apparent to those skilled in the art.

[0042] catheter

[0043] Figure 1 A catheter 100 for mechanically inhibiting occlusion formation is shown in accordance with some embodiments. Figure 3 Shown is a detailed view of a catheter hub 102 of a catheter 100 including a controller 104 and an internal power source 106 incorporated into a portion of the catheter hub 102 according to some embodiments. Figure 7 According to some embodiments, Figure 1 A block diagram of a catheter 100 is shown.

[0044] like Figure 1 and Figure 3As shown, the catheter 100 may include a catheter tube 108, a catheter hub 102, and one or more extension legs 110, which are coupled together in the aforementioned order. In practice, the catheter tube 108 may include a proximal portion disposed in the catheter hub 102, and each of the one or more extension legs 110 may include a distal portion disposed in the catheter hub 102. In some embodiments, such a catheter 100 may be a CVC or a PICC; however, it should be understood that the catheter 100 is not limited thereto, as the catheter 100 may be any catheter intended for placement in a patient's vasculature for a time sufficient to form a thrombotic or non-thrombotic occlusion.

[0045] Figure 2 Shown is a detailed view of a catheter tube 108 of a catheter 100 including a plurality of piezoelectric transducers 112 along the length of the catheter tube 108 according to some embodiments.

[0046] like Figure 2 As shown, the catheter tubing 108 may incorporate a plurality of piezoelectric transducers 112 into the aforementioned length of the catheter tubing 108. Through the inverse piezoelectric effect, the plurality of piezoelectric transducers 112 may be configured as a plurality of vibrators for use, such as to vibrate when the catheter tubing 108 is placed in the vasculature of the patient for a period of time and thereby inhibit the accumulation of thrombotic or non-thrombotic occlusions on the luminal surface of the catheter tubing 108, the distal luminal surface of the catheter tubing 108, or both the luminal surface and the distal luminal surface of the catheter tubing 108 by means of anti-adhesion vibrations along the length of the catheter tubing 108 including the plurality of piezoelectric transducers 112. For example, the plurality of piezoelectric transducers 112 configured as a plurality of vibrators may vibrate when the catheter tubing 108 is placed in the vasculature of the patient for a period of time and thereby inhibit the accumulation of thrombotic or non-thrombotic occlusions on the luminal surface of the catheter tubing 108, the distal luminal surface of the catheter tubing 108, or both the luminal surface and the distal luminal surface of the catheter tubing 108 by means of anti-adhesion vibrations along the length of the catheter tubing 108 including the plurality of piezoelectric transducers 112. Figure 8 ), accumulation of non-thrombotic biological materials (such as biofilms), or a combination thereof. Because the anti-adhesion vibration along the length of the catheter tubing 108 inhibits the accumulation of non-thrombotic biological materials (such as biofilms), the catheter tubing 108 does not need to be formed of an antimicrobial material, formed of a material containing an antimicrobial agent, coated with an antimicrobial coating, or any combination thereof.

[0047] The plurality of piezoelectric transducers 112 and any electrical leads 114 connecting the plurality of piezoelectric transducers 112 to the controller 104 may be implemented in a flexible electronic device, wherein the plurality of piezoelectric transducers 112 may be formed of lead zirconate titanate (“PZT”) or polyvinylidene fluoride (“PVDF”), and wherein each piezoelectric transducer in the plurality of piezoelectric transducers 112 may have the same or different dimensions as another piezoelectric transducer in the plurality of piezoelectric transducers 112. Such flexible electronic devices may be fabricated on the luminal surface of the catheter tubing 108, fabricated on the distal luminal surface of the catheter tubing 108, or disposed between the luminal surface and the distal luminal surface of the catheter tubing 108. When the flexible electronic device is fabricated on the luminal surface of the catheter tubing 108, the catheter tubing 108 may be extruded on a tubular polymer substrate including the flexible electronic device, the extruded catheter tubing 108 having the same or different polymer as the tubular substrate. Alternatively, the tubular substrate including the flexible electronics can be dip coated in a coating mixture that also has the same or different polymer as the tubular substrate. When the flexible electronics are disposed between the luminal surface and the distal luminal surface of the catheter tubing 108, the flexible electronics can be fabricated on the inner layer of the catheter tubing 108, wherein the outer layer of the catheter tubing 108 is extruded or dip coated thereon, the outer layer of the catheter tubing 108 being the same or different polymer as the inner layer of the catheter tubing 108.

[0048] It is worth noting that the thickness of the flexible electronic device can be at least about 1 μm, including at least about 20 μm, such as at least about 50 μm, for example, at least about 80 μm, 100 μm or 500 μm. Alternatively, the thickness of the flexible electronic device can be no greater than about 500 μm, including no greater than about 100 μm, such as no greater than about 80 μm, for example, no greater than about 50 μm, 20 μm or 1 μm. For example, the thickness of the flexible electronic device can be in the range from about 1 μm to about 500 μm.

[0049] Advantageously, individual piezoelectric transducers in the plurality of piezoelectric transducers 112, individual groups of piezoelectric transducers in the plurality of piezoelectric transducers 112, or combinations of individual piezoelectric transducers and individual groups of piezoelectric transducers can be configured to be individually electronically addressable via dedicated electrical leads 114 to each piezoelectric transducer in the plurality of piezoelectric transducers 112 or each group of piezoelectric transducers in the plurality of piezoelectric transducers 112. The ability of individual piezoelectric transducers, individual groups of piezoelectric transducers, or combinations of individual piezoelectric transducers and individual groups of piezoelectric transducers to be individually electronically addressable allows the anti-stiction vibrations along the length of the catheter tubing 108 to be customized in terms of frequency, amplitude, or pulse waveform via the location or specific locations of the individual piezoelectric transducers or individual groups of piezoelectric transducers. In addition, individual piezoelectric transducers, individual groups of piezoelectric transducers, or a combination of individual piezoelectric transducers and individual groups of piezoelectric transducers can be individually electronically addressed to allow the distal portion of catheter tubing 108 to be cut to achieve the desired placement length of catheter tubing 108. The remaining piezoelectric transducers of the plurality of piezoelectric transducers 112 that are not cut with the distal portion of catheter tubing 108 remain capable of anti-stick vibration along the placement length of catheter tubing 108 according to being able to be individually electronically addressed. Therefore, when catheter 100 is configured as a PICC, catheter 100 maintains both the fixed-length cut-to-length characteristics of a PICC and its ability to mechanically inhibit occlusion formation as described herein.

[0050] Notwithstanding the foregoing, it should be understood that the plurality of piezoelectric transducers 112 may alternatively be commonly addressed via a shared electrical lead 114. Commonly addressing the plurality of piezoelectric transducers 112 is simpler for the design and manufacture of the catheter 100, but commonly addressing the plurality of piezoelectric transducers 112 forgoes the benefit of being able to tailor the anti-stiction vibration along the length of the catheter tubing 108 in terms of frequency, amplitude, or pulse waveform by the location or specific sites of individual piezoelectric transducers or individual groups of piezoelectric transducers. Furthermore, in some embodiments, commonly addressing the plurality of piezoelectric transducers 112 may forgo the benefit of being able to cut the catheter 100 to length while maintaining its ability to mechanically inhibit occlusion formation as described herein.

[0051] Through the piezoelectric effect, the plurality of piezoelectric transducers 112 may be further configured as a plurality of sensors for sensing and thereby monitoring environmental conditions of the catheter tube 108 when the catheter tube 108 is placed in the vasculature. Such environmental conditions may include fluid pressure, fluid flow, temperature, infiltration or extravasation in or around the catheter 100, heart rate, acoustic signals from the heart (e.g., heart murmur), etc.

[0052] like Figure 3As shown, the controller 104 and the internal power source 106 can be incorporated into a portion of the catheter hub 102. Alternatively, the controller 104 and the internal power source 106 can be incorporated into the suture wings 116 of the catheter hub 102. In any case, as shown in FIG. Figure 7 As shown, the controller 104 may include components selected from at least a processor 118 , an auxiliary memory 120 , and a sensor interface 122 .

[0053] Processor 118 may include control unit 124, computing unit 126, and primary memory 128 (e.g., cache memory, random access memory ["RAM"], or both), where primary memory 128 may be configured to store programs and data (e.g., sensor data) in use. Although primary memory 128 may be separate from processor 118 in use, primary memory 128 may be configured to store programs and data (e.g., sensor data) in use. Figure 7 The remaining parts mentioned in are located in the same package, but at least the aforementioned RAM can be distributed outside the package of processor 118, for example, in its own package. When the multiple piezoelectric transducers are configured in whole or in part as multiple sensors, processor 118 can also include an analog-to-digital converter ("ADC") 130 configured to convert electrical signals from the multiple piezoelectric sensors from analog to digital and a digital signal processor ("DSP") 132 configured to generate sensor data from the electrical signals. Although ADC 130 and DSP 132 can be integrated with the processor 118 in Figure 7 The remaining components mentioned in are located in the same package, but ADC 130 and DSP 132 may be distributed outside of the package of processor 118, for example, in their own packages.

[0054] The secondary memory 120 may be configured to store data (e.g., sensor data) and programs including instructions, logic (including vibration or sensing logic), algorithms (including vibration or sensing algorithms), or some combination thereof, for loading into the primary memory 128 for use by the processor 118, for example, in performing the following operations: modulating the drive voltage to customize the anti-adhesion vibration when the catheter tubing 108 is placed in the vasculature or determining the environmental conditions of the catheter tubing 108 based on the sensor data. In practice, the plurality of piezoelectric transducers 112 may be excited according to any mode or combination of modes selected from a continuous mode, a pulse mode, or a burst mode, and the modes for exciting the plurality of piezoelectric transducers 112 are stored in the secondary memory 120 for loading into the primary memory 128 as needed for use by the processor 118 for preventing adhesion of thrombotic or non-thrombotic occlusions or removing any existing accumulation.

[0055] The sensor interface 122 may include a signal conditioner 134 configured to normalize electrical signals from the plurality of piezoelectric sensors through voltage or current limiting, anti-aliasing filtering, etc. Additionally, the sensor interface 122 may include an amplifier 136 configured to amplify the electrical signal and thereby increase its signal-to-noise ratio.

[0056] The internal power source 106 can be configured to power the controller 104 and the plurality of piezoelectric transducers 112. Such an internal power source 106 can be an internal battery that can be recharged through a port in the catheter hub 102. Optionally, the internal battery is a lithium-ion battery, a button cell, or a flexible battery used with the remainder of the flexible electronics. Despite the foregoing, the internal power source 106 can alternatively be an external power source configured for wired or wireless power.

[0057] The controller 104 may be configured to control at least the plurality of piezoelectric transducers 112, whether the plurality of piezoelectric transducers 112 are configured as a plurality of vibrators, a plurality of sensors, or both a plurality of vibrators and a plurality of sensors. When the plurality of piezoelectric transducers 112 are configured as both a plurality of vibrators and a plurality of sensors, a portion of the plurality of piezoelectric transducers 112 may be specifically configured as a plurality of vibrators, and another portion of the plurality of piezoelectric transducers 112 may be specifically configured as a plurality of sensors. Alternatively, the plurality of piezoelectric transducers 112 may be configured to operate independently as vibrators or sensors according to control signals provided thereto by the controller 104.

[0058] When the plurality of piezoelectric transducers 112 are configured in whole or in part as a plurality of vibrators, the controller 104 may be configured to vibrate the plurality of vibrators at a frequency of at least about 30 Hz, including at least about 1 kHz, such as at least about 20 kHz, for example, at least about 50 kHz, 100 kHz, 150 kHz, 200 kHz, 250 kHz, 500 kHz, 5 MHz, or 15 MHz. Alternatively, the controller 104 may be configured to vibrate the plurality of vibrators at a frequency of not greater than about 15 MHz, including not greater than about 5 MHz, such as not greater than about 500 kHz, for example, not greater than about 250 kHz, 200 kHz, 150 kHz, 100 kHz, 50 kHz, 20 kHz, 1 kHz, or 30 Hz. For example, the controller 104 may be configured to vibrate the plurality of vibrators at a frequency in the range from about 30 Hz to about 15 MHz, including from about 1 kHz to about 5 MHz, such as from about 20 kHz to about 250 kHz, for example, from about 20 kHz to about 150 kHz.

[0059] In addition, when the plurality of piezoelectric transducers 112 are configured in whole or in part as a plurality of vibrators, the controller 104 may be configured to vibrate the plurality of vibrators with an amplitude of at least about 1 nm, including at least about 100 nm, such as at least about 200 nm, for example, at least about 300 nm, 400 nm, 500 nm, 10 μm, or 100 μm. Alternatively, the controller 104 may be configured to vibrate the plurality of vibrators with an amplitude of no greater than about 100 μm, including no greater than about 10 μm, such as no greater than about 500 nm, for example, no greater than about 400 nm, 300 nm, 200 nm, 100 nm, or 1 nm. For example, the controller 104 may be configured to vibrate the plurality of vibrators with an amplitude in the range of about 1 nm to about 100 μm. Notably, constructive interference of superposition of vibration waves from at least adjacent piezoelectric transducers can advantageously increase amplitude in one or more locations or specific sites along the length of catheter tube 108 as desired to inhibit accumulation of thrombotic or non-thrombotic occlusions.

[0060] It is worth noting that the power consumption of the plurality of piezoelectric transducers 112 depends on a combination of the size, vibration frequency, and vibration amplitude of the piezoelectric transducers, and may range from about 1 μW to about 100 mW.

[0061] Catheter components

[0062] Figure 4 Another catheter 138 for mechanically inhibiting occlusion formation is shown according to some embodiments, and Figure 5 A detailed view of a base plate 140 of a catheter securing device 142 for a catheter 138 is shown, according to some embodiments, the catheter securing device 142 including a controller 104 and an internal power source 106 incorporated into the base plate 140 . Figure 6 A catheter 138 is shown secured in a catheter securing device 142, thereby forming a catheter assembly 144 for mechanically inhibiting occlusion formation, according to some embodiments. Figure 7 According to some embodiments, Figure 6 A block diagram of the catheter assembly 144 is provided.

[0063] like Figures 4 to 6 As shown, the catheter assembly 144 may include a catheter 138 and a catheter fixing device 142, wherein the plurality of piezoelectric transducers 112, the controller 104, and the internal power source 106 are distributed between the separate components of the catheter assembly 144, namely, between the catheter 138 and the catheter fixing device 142.

[0064] Similar to the catheter 100 described above, Figure 4 and Figure 6The catheter 138 may include a catheter tube 108, a catheter hub 102, and one or more extension legs 110, which are connected together in the aforementioned order. In addition, as described above, the catheter tube 108 may include a plurality of piezoelectric transducers 112 and electrical leads 114 along the length of the catheter tube 108. Unlike the catheter 100 described above, the catheter 138 does not need to include a controller 104 or an internal power supply 106, which are disposed in a catheter fixture 142, as described below. Therefore, the catheter 138 can be configured so that the suture wing through hole 146 of the suture wing 116 includes ring contacts 148, which are operably connected to the plurality of piezoelectric transducers 112 via electrical leads 114 for powering the plurality of piezoelectric transducers 112 of the catheter tube 108 and controlling the plurality of piezoelectric transducers.

[0065] like Figure 5 As shown, the catheter securing device 142 may include a pad 150 and a retainer 152 fixedly coupled together, the catheter securing device 142 being configured to secure the catheter 138 to a patient when the catheter tube 108 of the catheter 138 is placed within the vasculature of the patient.

[0066] The pad 150 may include a skin-facing side including an adhesive thereon for adhering the catheter securing device 142 to the patient after removing the liner on the skin-facing side of the pad 150. The pad 150 may also include an exposed side opposite the skin-facing side of the pad 150, with the retainer 152 fixedly attached to the exposed side.

[0067] The holder 152 may include a base plate 140, a pair of posts 154 extending from the base plate 140, and a top cover 156, wherein the base plate 140, the top cover 156, or both the base plate 140 and the top cover 156 include the controller 104 and the internal power supply 106. Figure 5As shown, both the controller 104 and the internal power source 106 can be incorporated into the base plate 140 of the holder 152; however, in some embodiments, the controller 104 and the internal power source 106 can alternatively be distributed between the base plate 140 and the top cover 156. Regardless of whether the controller 104 and the internal power source 106 are incorporated into the base plate 140, the top cover 156, or distributed between the base plate 140 and the top cover 156 of the catheter fixture 142, the catheter fixture 142 can include fixture-based electrical connectors in the base plate 140 or the top cover 156 for connecting to the catheter-based electrical connectors to power and control the plurality of piezoelectric transducers 112. For example, a pair of posts 154 extending from the substrate 140 can be configured as a catheter-based electrical connector for connecting to the ring contact 148 of the suture wing 116 of the catheter 138 (as a catheter-based electrical connector) for powering and controlling multiple piezoelectric transducers 112 of the catheter tube 108 of the catheter 138. Figure 5 and Figure 6 The top cover 156 shown in the figure (which is formed by two movable hinged top cover pieces) can be configured to cover the sewing wings 116 of the catheter 138 and hold it in place on a pair of posts 154 extending from the substrate 140, thereby maintaining sufficient electrical contact for powering and controlling the multiple piezoelectric transducers 112.

[0068] It is noteworthy that although the catheter assembly 144 may include a plurality of piezoelectric transducers 112, a controller 104, and an internal power source 106 distributed in a separate component of the catheter assembly 144 (i.e., distributed between the catheter 138 and the catheter fixing device 142), the catheter assembly 144 need not be limited to the aforementioned configuration. In fact, the controller 104 and the internal power source 106 may instead be housed in a separate controller unit that is independent of the catheter fixing device 142. Such a controller unit may be configured with a plug for insertion into a port of the catheter hub 102 of the catheter 138, etc., and the controller unit may be easily replaced with another powered controller unit as needed to maintain mechanical suppression of occlusion formation in the catheter tubing 108 of the catheter 138 with minimal interruption. That is, a plurality of piezoelectric transducers 112, a controller 104, and an internal power source 106 may be incorporated into a single-component catheter assembly (such as the catheter 100 described above).

[0069] method

[0070] Methods may include methods of using and manufacturing the catheter 100 or catheter assembly 144 .

[0071] With respect to methods of using catheter 100 or catheter assembly 144, such methods may include one or more operations selected from a resection operation, a placement operation, a fixation operation, a powering operation, and a customization operation.

[0072] The cutting operation may precede the placement operation, as the cutting operation may include cutting the distal portion of catheter tubing 108 to achieve the desired placement length of catheter tubing 108. As described above, individual piezoelectric transducers, individual groups of piezoelectric transducers, or a combination of individual piezoelectric transducers and individual groups of piezoelectric transducers are individually electronically addressed to allow the remaining piezoelectric transducers of the plurality of piezoelectric transducers 112 that were not cut with the distal portion of catheter tubing 108 to vibrate along the placement length of catheter tubing 108 in accordance with being individually electronically addressed.

[0073] The placement procedure may include placing the catheter 100 or 138 in the patient's vasculature, such as by the Seldinger technique.

[0074] The securing operation may include securing the catheter 100 or 138 to the patient. With respect to the catheter 138, the securing operation may include securing the catheter 138 in the catheter securing device 142, which in turn may include arranging the suture wings 116 of the catheter 138 in the substrate over a pair of posts 154 extending from the substrate 140 so that the ring contacts 148 of the suture wings 116 form sufficient electrical contact for powering and controlling the plurality of piezoelectric transducers 112. Additionally, the securing operation may include covering the suture wings 116 of the catheter 138 to hold it in place over the pair of posts 154 and maintain electrical contact for powering and controlling the plurality of piezoelectric transducers 112.

[0075] The powering operation may include supplying power to the catheter 100 or the catheter assembly 144 through the internal power source 106. Such powering operation activates the controller 104 including the processor 118 and the memory to control the plurality of piezoelectric transducers 112 to vibrate and thereby inhibit the accumulation of biomaterial on the luminal surface of the catheter tubing 108, the distal luminal surface of the catheter tubing 108, or both the luminal surface and the distal luminal surface of the catheter tubing 108 by means of anti-adhesion vibration along the length of the catheter tubing 108.

[0076] The customized operation may include imaging the catheter 100 or 138 via ultrasound or the like, determining where a thrombotic or non-thrombotic occlusion is located in the catheter tubing 108, and applying a customized vibration where the thrombotic or non-thrombotic occlusion is located in the catheter tubing 108 if such an occlusion is present. The customized vibration may be customized in terms of frequency, amplitude, or pulse waveform, and may be provided by one or more individual piezoelectric transducers or individual groups of one or more piezoelectric transducers where the thrombotic or non-thrombotic occlusion is located in the catheter tubing 108. Furthermore, the above-described burst mode may be used in the customized vibration to provide vibration frequencies up to the MHz range and vibration amplitudes up to the μm range in order to disrupt thrombotic or non-thrombotic occlusions located in the catheter tubing 108. Advantageously, similar to any anti-stick vibrations provided along the length of the catheter tubing 108 described herein, such customized vibrations can be confined to the luminal surface or distal luminal surface of the catheter tubing 108 as surface waves thereon, thereby selectively aiming the luminal surface or distal luminal surface of the catheter tubing 108 relative to the other.

[0077] Advantageously, once catheter 100 or 138 is placed and power is supplied to catheter 100 or catheter assembly 144, respectively, according to the placement and powering operations, no further intervention by the clinician (e.g., catheter flushing, antibiotic lock therapy, etc.) is required until internal power source 106 is recharged or replaced. Furthermore, because internal power source 106 prevents the patient from being connected to an external power source, the patient can enjoy as much mobility as the patient is otherwise permitted.

[0078] With respect to methods of manufacturing the catheter 100 or catheter assembly 144, such methods may include one or more operations selected from manufacturing operations and assembly operations.

[0079] The manufacturing operation may include manufacturing the flexible electronic device on the lumen surface of the catheter tubing 108, manufacturing the flexible electronic device on the distal lumen surface of the catheter tubing 108, or arranging the flexible electronic device between the lumen surface and the distal lumen surface of the catheter tubing 108. Such manufacturing of the flexible electronic device may include using a contact-type flexible electronic device manufacturing method selected from screen printing, flexographic printing, gravure printing, and soft lithography. Alternatively, the manufacturing of the flexible electronic device may include using a non-contact flexible electronic device manufacturing method selected from multiphoton lithography or direct laser writing lithography, aerosol printing, and inkjet printing. According to what has been described above for the flexible electronic device manufactured on the lumen surface of the catheter tubing 108, the flexible electronic device may be manufactured on a tubular substrate or even as a tubular substrate, and the remainder of the catheter tubing 108 may be extruded or dip-coated thereon. And as explained above for flexible electronics disposed between the luminal and distal luminal surfaces of catheter tubing 108, flexible electronics may be fabricated on the inner layer of catheter tubing 108 and the outer layer of catheter tubing 108 may be extruded or dip coated thereon.

[0080] The assembly operation may include inserting or otherwise arranging the proximal portion of the catheter tube 108 into the catheter hub 102. Additionally, the assembly operation may include inserting or otherwise arranging the distal portion of each of the one or more extension legs 110 into the catheter hub 102.

[0081] Although some specific embodiments have been disclosed herein, and although these specific embodiments have been disclosed in considerable detail, these specific embodiments are not intended to limit the scope of the concepts provided herein. Additional adaptations or modifications may be envisioned by those of ordinary skill in the art, and in broader aspects, these adaptations or modifications are also encompassed. Therefore, changes may be made to the specific embodiments disclosed herein without departing from the scope of the concepts provided herein.

Claims

1. A catheter assembly, characterized in that: include: A catheter, the catheter comprising: a catheter tube incorporating a plurality of piezoelectric transducers into a length of the catheter tube, the plurality of piezoelectric transducers configured as a plurality of vibrators for vibrating when the catheter tube is placed in a vasculature and thereby inhibiting accumulation of biomaterial on a luminal surface of the catheter tube, a distal luminal surface of the catheter tube, or both the luminal and distal luminal surfaces of the catheter tube by virtue of vibrations along the length of the catheter tube; and a catheter hub in which the proximal portion of the catheter tube is disposed; a controller comprising a processor and a memory, the controller being configured to control at least the plurality of piezoelectric transducers; and An internal power source is configured to provide power to the controller and the plurality of piezoelectric transducers.

2. The catheter assembly according to claim 1, characterized in that The multiple piezoelectric transducers and the electrical leads connecting the multiple piezoelectric transducers to the controller are flexible electronic devices, which are manufactured on the inner cavity surface of the catheter tube, manufactured on the distal inner cavity surface of the catheter tube, or arranged between the inner cavity surface and the distal inner cavity surface of the catheter tube.

3. The catheter assembly according to claim 2, characterized in that The internal power source is a lithium-ion battery or a flexible battery.

4. The catheter assembly according to claim 2, characterized in that The thickness of the flexible electronic device ranges from 1 μm to 500 μm.

5. The catheter assembly according to claim 1, characterized in that Individual piezoelectric transducers of the plurality of piezoelectric transducers, individual groups of piezoelectric transducers of the plurality of piezoelectric transducers, or combinations of the individual piezoelectric transducers and the individual groups of piezoelectric transducers are individually electronically addressed.

6. The catheter assembly according to claim 5, characterized in that The individual piezoelectric transducers, individual groups of piezoelectric transducers, or the combination of individual piezoelectric transducers and individual groups of piezoelectric transducers are individually electronically addressable allowing the vibrations along the length of the catheter tube to be customized by the position of the individual piezoelectric transducers or individual groups of piezoelectric transducers.

7. The catheter assembly according to claim 5, characterized in that The individual piezoelectric transducers, individual groups of the piezoelectric transducers, or a combination of the individual piezoelectric transducers and the individual groups of piezoelectric transducers are individually electronically addressed to allow the distal portion of the catheter tube to be cut away to achieve a desired placement length of the catheter tube, and the remaining piezoelectric transducers of the plurality of piezoelectric transducers are capable of vibrating along the placement length of the catheter tube in accordance with being individually electronically addressed.

8. The catheter assembly according to claim 1, characterized in that The plurality of piezoelectric transducers are further configured as a plurality of sensors for sensing and thereby monitoring environmental conditions of the catheter tube when the catheter tube is placed in the vasculature.

9. The catheter assembly according to claim 1, characterized in that The controller and the internal power source are incorporated into a portion of the catheter hub.

10. The catheter assembly according to claim 1, characterized in that The controller and the internal power source are incorporated into the sewing wings of the catheter hub.

11. The catheter assembly according to claim 1, characterized in that The controller and the internal power supply are incorporated into a base plate or top cover of a catheter fixture, wherein the base plate or top cover of the catheter fixture includes a fixture-based electrical connector for connecting to a catheter-based electrical connector to power and control the multiple piezoelectric transducers.

12. The catheter assembly according to claim 1, characterized in that The controller is configured to vibrate the plurality of piezoelectric transducers at a frequency in a range of 30 Hz to 15 MHz and an amplitude in a range of 1 nm to 100 μm.

13. The catheter assembly according to claim 1, characterized in that The accumulation of biological material is an intraluminal thrombus, a fibrin tail, a fibrin sheath, a mural thrombus, a biofilm, or a combination thereof.

14. The catheter assembly according to claim 1, characterized in that The catheter is a central venous catheter or a peripherally inserted central catheter.

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