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 of U.S. Provisional Application No. 63 / 471,744, filed on June 7, 2023, the entire disclosure of which is incorporated herein by reference. Technical Field

[0003] This application 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 result in ineffective drug therapy and complications such as infiltration, phlebitis, or infection. The aforementioned occlusions can occur in a variety of different ways. In one example, as Figure 8 shown, thrombotic occlusions can occur when one or more thrombi form within, around, or at the distal portion of the catheter. In another example, non-thrombotic occlusions can occur due to biofilm formation, lipid residues from lipid-containing nutritional mixtures or pharmaceutical formulations including oily carriers, or drug precipitates from the same or different pharmaceutical formulations within, around, or at the distal portion of the catheter. There is a need for catheters, catheter assemblies, and methods for inhibiting the formation of such occlusions. Disclosed herein are catheters, catheter assemblies, and methods for solving the foregoing problems by mechanically inhibiting the formation of such occlusions. Summary of the Utility Model

[0005] In some embodiments, disclosed herein is a catheter assembly that includes a catheter, a controller, and an internal power source. The catheter includes a catheter tube and a catheter liner, and a proximal portion of the catheter tube is disposed within the catheter liner. The catheter tube incorporates a plurality of piezoelectric transducers along the length of the catheter tube. The plurality of piezoelectric transducers are configured as a plurality of vibrators for vibrating when the catheter tube is placed in the vasculature and thereby inhibiting the accumulation of biological materials on the inner lumen surface of the catheter tube, the distal inner lumen surface of the catheter tube, or both the inner lumen surface and the distal inner lumen surface of the catheter tube by means of vibration along the length of the catheter tube. The controller includes a processor and a memory, and the controller is configured to control at least the plurality of piezoelectric transducers. The internal power source is configured to power the controller and the plurality of 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 electronics. The flexible electronics are fabricated on the inner lumen surface of the catheter tube, on the distal inner lumen surface of the catheter tube, or disposed between the inner lumen surface and the distal inner lumen 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, an individual piezoelectric transducer among the plurality of piezoelectric transducers, an individual group of piezoelectric transducers among the plurality of piezoelectric transducers, or a combination of an individual piezoelectric transducer and an individual group of piezoelectric transducers is individually electronically addressed.

[0010] In some embodiments, individually electronically addressing an individual piezoelectric transducer, an individual group of piezoelectric transducers, or a combination of an individual piezoelectric transducer and an individual group of piezoelectric transducers allows customization of the vibration along the length of the catheter fitting by the position of the individual piezoelectric transducer or the individual group of piezoelectric transducers.

[0011] In some embodiments, individually electronically addressing an individual piezoelectric transducer, an individual group of piezoelectric transducers, or a combination of an individual piezoelectric transducer and an individual group of piezoelectric transducers allows excision of the distal portion of the catheter fitting to achieve a desired placement length of the catheter fitting. The remaining piezoelectric transducers among the plurality of piezoelectric transducers that are not excised with the distal portion of the catheter fitting are capable of vibrating along the placement length of the catheter fitting according to 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 the environmental conditions of the catheter fitting when the catheter fitting is placed in the vasculature.

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

[0014] In some embodiments, the controller and the internal power source are incorporated into the substrate or the top cover of the catheter fixing device. The substrate or the top cover of the catheter fixing device includes fixing device-based electrical connectors for connection to catheter-based electrical connectors to supply power to 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 the range of about 30 Hz to about 15 MHz and an amplitude in the range of about 1 nm to about 100 μm.

[0016] In some embodiments, the accumulation of biological material is an intraluminal thrombus, fibrin tail, fibrin sheath, mural thrombus, 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 the catheter of the catheter assembly in the vasculature of a patient. The catheter includes a catheter tube and a catheter bushing, and a proximal portion of the catheter tube is disposed in the catheter bushing. The catheter tube incorporates a plurality of piezoelectric transducers into the length of the catheter tube. The plurality of piezoelectric transducers are configured as a plurality of vibrators. The power supply operation includes powering the catheter assembly by means of an internal power source. The power supply operation activates a controller including a processor and a memory, and the controller is configured to control the plurality of piezoelectric transducers to vibrate and thus inhibit the accumulation of biological material on the inner lumen surface of the catheter tube, the distal inner lumen surface of the catheter tube, or both the inner lumen surface and the distal inner lumen surface of the catheter tube by means of the 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 electronics. The flexible electronics are fabricated on the inner lumen surface of the catheter tube, on the distal inner lumen surface of the catheter tube, or disposed between the inner lumen surface and the distal inner lumen surface of the catheter tube.

[0020] In some embodiments, an individual piezoelectric transducer among the plurality of piezoelectric transducers, an individual group of piezoelectric transducers among the plurality of piezoelectric transducers, or a combination of an individual piezoelectric transducer and an individual group of piezoelectric transducers is individually electronically addressed.

[0021] In some embodiments, individually electronically addressing an individual piezoelectric transducer, an individual group of piezoelectric transducers, or a combination of an individual piezoelectric transducer and an individual group of piezoelectric transducers allows customization of the vibration along the length of the catheter tube by the position of the individual piezoelectric transducer or the individual group of piezoelectric transducers.

[0022] In some embodiments, the method further includes an excision operation prior to the placement operation of placing the catheter in the vasculature of a patient. The excision operation includes excising a distal portion of the catheter tubing to achieve a desired placement length of the catheter tubing. A single piezoelectric transducer, a single group of piezoelectric transducers, or a combination of a single piezoelectric transducer and a single group of piezoelectric transducers is individually electronically addressed to allow the remaining piezoelectric transducers among the plurality of piezoelectric transducers that are not excised 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 power supply operation of powering the catheter assembly.

[0023] In some embodiments, the plurality of piezoelectric transducers are further configured as a plurality of sensors for sensing and thus monitoring environmental conditions of the catheter tubing during a placement operation of placing the catheter in the vasculature of a patient and a power supply operation of powering and activating a controller of the catheter assembly.

[0024] In some embodiments, the controller and the internal power supply are incorporated into a portion of the catheter bushing. Optionally, the controller and the internal power supply are incorporated into a suture wing of the catheter bushing.

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

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

[0027] Figure 1 A catheter for mechanically inhibiting occlusion formation according to some embodiments is shown.

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

[0029] Figure 3 A detailed view of a catheter bushing of a catheter according to some embodiments is shown, the catheter bushing including a controller and an internal power supply incorporated into a portion of the catheter bushing.

[0030] Figure 4 Another catheter for mechanically inhibiting occlusion formation according to some embodiments is shown.

[0031] Figure 5 Shown is according to some embodiments for Figure 4Detailed view of the substrate of a catheter fixation device for a catheter, the catheter fixation device including a controller and an internal power source incorporated into the substrate.

[0032] Figure 6 Shows a catheter fixed in Figure 5 the catheter fixation device of Figure 4 to form a catheter assembly for mechanically inhibiting occlusion formation.

[0033] Figure 7 Shows a Figure 1 catheter or Figure 6 block diagram of the catheter assembly of

[0034] Figure 8 Shows various thrombotic occlusions 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 can have features that can be easily separated from the specific embodiments, and these features can optionally be combined with the features of any one of many other embodiments disclosed herein or replace the features of any one of many other embodiments disclosed herein.

[0036] Regarding 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 group of features or steps, and do not provide a sequence or numerical limitation. For example, the "first", "second", and "third" features or steps do not necessarily occur in that order, and a specific embodiment including such features or steps is not necessarily limited to these three features or steps. Additionally, unless otherwise specified, any of the foregoing features or steps can further include one or more features or steps. For convenience, labels such as "left", "right", "top", "bottom", "front", "rear", etc. are used, and these labels are not intended to imply, for example, any specific fixed position, orientation, or direction. Instead, 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 dictates otherwise.

[0037] "Proximal" is used to indicate the part, 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, the "proximal part" or "proximal segment" of a medical device includes the part or segment of the medical device that is intended to be placed near the clinician when the medical device is used on a patient. Similarly, the "proximal length" of a medical device includes the length of the medical device that is intended to be placed near the clinician when the medical device is used on a patient. The "proximal end" of a medical device includes the end that is intended to be placed near the clinician when the medical device is used on a patient. The proximal part, proximal segment, or proximal length of a medical device need not include the proximal end of the medical device. In fact, the proximal part, proximal segment, or proximal length of a medical device can be shorter than the proximal end of the medical device. However, the proximal part, proximal segment, or proximal length of a medical device can include the proximal end of the medical device. If the context does not indicate that the proximal part, proximal segment, or proximal length of a medical device includes the proximal end of the medical device, or if it is considered advantageous in the following description, the "proximal part", "proximal segment", or "proximal length" can be modified to indicate that such part, segment, or length respectively includes the end part, end segment, or end length of the medical device to refer to the "proximal part", "proximal segment", or "proximal length" of the medical device.

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

[0039] 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 to which this disclosure pertains.

[0040] Occlusions in catheters (including CVCs and PICCs) can inhibit or even prevent fluid flow through such catheters. This can result in ineffective drug therapy and complications such as infiltration, phlebitis, or infection. The aforementioned occlusions can occur in a variety of different ways. In one example, as Figure 8 shown, thrombotic occlusions can occur when one or more thrombi form within, around, or at the distal portion of the catheter. In another example, non-thrombotic occlusions can occur due to biofilm formation, lipid residues from lipid-containing nutritional mixtures or pharmaceutical formulations including lipid carriers, or drug precipitation from the same or different pharmaceutical formulations within, around, or at the distal portion of the catheter. There is a need for catheters, catheter assemblies, and methods for inhibiting the formation of such occlusions. Disclosed herein are catheters, catheter assemblies, and methods for solving the aforementioned problems by mechanically inhibiting the formation of such occlusions.

[0041] For example, a catheter assembly can include a catheter, a controller, and an internal power source. The catheter can include a catheter tubing and a catheter sleeve, wherein a proximal portion of the catheter tubing can be disposed within the catheter sleeve. The catheter tubing can incorporate a plurality of piezoelectric transducers along the length of the catheter tubing. The plurality of piezoelectric transducers can be configured as a plurality of vibrators for vibrating when the catheter tubing is placed within the vasculature and thereby inhibiting the accumulation of biological material on the inner lumen surface or the distal inner lumen surface of the catheter tubing by means of vibrations along the length of the catheter tubing. The controller can include a processor and a memory, wherein the controller can be configured to control at least the plurality of piezoelectric transducers. The internal power source can be configured to power the controller and the plurality of piezoelectric transducers. Such catheter assemblies and their features will become more apparent to those skilled in the art in view of the drawings and the following description.

[0042] Catheter

[0043] Figure 1 illustrates a catheter 100 for mechanically inhibiting occlusion formation according to some embodiments. Figure 3 illustrates a detailed view of a catheter sleeve 102 of the catheter 100 according to some embodiments, the catheter sleeve including a controller 104 and an internal power source 106 incorporated into a portion of the catheter sleeve 102. Figure 7 illustrates according to some embodiments Figure 1 a block diagram of the catheter 100.

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

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

[0046] As Figure 2 shown, the catheter fitting 108 can incorporate a plurality of piezoelectric transducers 112 into the foregoing length of the catheter fitting 108. Through the inverse piezoelectric effect, the plurality of piezoelectric transducers 112 can be configured as a plurality of vibrators for vibrating, for example, when the catheter fitting 108 is placed in a patient's vasculature for a period of time, and thereby suppressing the accumulation of thrombotic or non-thrombotic occlusion on the inner lumen surface of the catheter fitting 108, the distal inner lumen surface of the catheter fitting 108, or both the inner lumen surface and the distal inner lumen surface of the catheter fitting 108 by means of anti-adhesion vibration along the length of the catheter fitting 108 including the plurality of piezoelectric transducers 112. For example, the plurality of piezoelectric transducers 112 configured as a plurality of vibrators can vibrate when the catheter fitting 108 is placed in a patient's vasculature for a period of time, and thereby suppress the accumulation of thrombotic biomaterials (such as intraluminal thrombus, fibrin tail, fibrin sheath, or mural thrombus, each of which is shown in Figure 8 ), non-thrombotic biomaterials (such as biofilm), or a combination thereof. Since the anti-adhesion vibration along the length of the catheter fitting 108 suppresses the accumulation of non-thrombotic biomaterials (such as biofilm), the catheter fitting 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] A plurality of piezoelectric transducers 112 and any electrical leads 114 that connect the plurality of piezoelectric transducers 112 to the controller 104 can be implemented in a flexible electronic device, where the plurality of piezoelectric transducers 112 can be formed of lead zirconate titanate (“PZT”) or polyvinylidene fluoride (“PVDF”), and where each piezoelectric transducer in the plurality of piezoelectric transducers 112 can have the same or different dimensions as another piezoelectric transducer in the plurality of piezoelectric transducers 112. Such flexible electronic devices can be fabricated on the inner lumen surface of the conduit fitting 108, on the distal inner lumen surface of the conduit fitting 108, or disposed between the inner lumen surface and the distal inner lumen surface of the conduit fitting 108. When the flexible electronic device is fabricated on the inner lumen surface of the conduit fitting 108, the conduit fitting 108 can be extruded over a tubular polymer substrate that includes the flexible electronic device, and the extruded conduit fitting 108 has the same or different polymer as the tubular substrate. Alternatively, the tubular substrate that includes the flexible electronic device can be dip-coated in a coating mixture that also has the same or different polymer as the tubular substrate. When the flexible electronic device is disposed between the inner lumen surface and the distal inner lumen surface of the conduit fitting 108, the flexible electronic device can be fabricated on an inner layer of the conduit fitting 108, where an outer layer of the conduit fitting 108 is extruded or dip-coated thereon, and the outer layer of the conduit fitting 108 is the same or different polymer as the inner layer of the conduit fitting 108.

[0048] Notably, 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, an individual piezoelectric transducer among the plurality of piezoelectric transducers 112, an individual group of piezoelectric transducers among the plurality of piezoelectric transducers 112, or a combination of an individual piezoelectric transducer and an individual group of piezoelectric transducers can be configured to be individually electronically addressed via dedicated electrical leads 114 leading to each piezoelectric transducer among the plurality of piezoelectric transducers 112 or each group of piezoelectric transducers among the plurality of piezoelectric transducers 112. The ability of an individual piezoelectric transducer, an individual group of piezoelectric transducers, or a combination of an individual piezoelectric transducer and an individual group of piezoelectric transducers to be individually electronically addressed allows for customization of the anti-adhesion vibration along the length of the catheter fitting 108 in terms of frequency, amplitude, or pulse waveform by the location of the individual piezoelectric transducer or individual group of piezoelectric transducers or specific loci. Additionally, the ability of an individual piezoelectric transducer, an individual group of piezoelectric transducers, or a combination of an individual piezoelectric transducer and an individual group of piezoelectric transducers to be individually electronically addressed allows for excision of the distal portion of the catheter fitting 108 to achieve a desired placement length of the catheter fitting 108. The remaining piezoelectric transducers among the plurality of piezoelectric transducers 112 that are not excised with the distal portion of the catheter fitting 108 remain capable of achieving anti-adhesion vibration along the placement length of the catheter fitting 108 in accordance with being able to be individually electronically addressed. Thus, when the catheter 100 is configured as a PICC, the catheter 100 both retains the fixed-length cutting characteristic of a PICC and retains its ability to mechanically inhibit occlusion formation as described herein.

[0050] Although the foregoing has been described, it should be understood that the plurality of piezoelectric transducers 112 can alternatively be addressed collectively via shared electrical leads 114. Addressing the plurality of piezoelectric transducers 112 collectively is simpler for the design and manufacture of the catheter 100, but addressing the plurality of piezoelectric transducers 112 collectively forfeits the benefit of being able to customize the anti-adhesion vibration along the length of the catheter fitting 108 in terms of frequency, amplitude, or pulse waveform by the location of the individual piezoelectric transducer or individual group of piezoelectric transducers or specific loci. Additionally, in some embodiments, addressing the plurality of piezoelectric transducers 112 collectively can forfeit the benefit of being able to cut the catheter 100 to a certain length while maintaining its ability to mechanically inhibit occlusion formation as described herein.

[0051] Via the piezoelectric effect, the plurality of piezoelectric transducers 112 can be further configured as a plurality of sensors for sensing and thus monitoring the environmental conditions of the catheter fitting 108 when the catheter fitting 108 is placed in the vasculature. Such environmental conditions can include fluid pressure, fluid flow, temperature, infiltration or extravasation within or around the catheter 100, heart rate, acoustic signals from the heart (e.g., heart murmurs), and the like.

[0052] As Figure 3As shown, the controller 104 and the internal power supply 106 can be incorporated into a portion of the catheter bushing 102. Optionally, the controller 104 and the internal power supply 106 can be incorporated into the suture wing 116 of the catheter bushing 102. In any case, as Figure 7 shown, the controller 104 can include components selected from at least the processor 118, the auxiliary memory 120, and the sensor interface 122.

[0053] The processor 118 can include a control unit 124, an arithmetic unit 126, and a main memory 128 (e.g., cache memory, random access memory [“RAM”], or both), where the main memory 128 can be configured to store programs and data in use (e.g., sensor data). Although the main memory 128 can be located within the same package as the remaining portions of the processor 118 mentioned in Figure 7 it, at least the aforementioned RAM can be distributed outside the package of the processor 118, e.g., in its own package. When multiple piezoelectric transducers are configured in whole or in part as multiple sensors, the 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 the ADC 130 and the DSP 132 can be located within the same package as the remaining portions of the processor 118 mentioned in Figure 7 it, the ADC 130 and the DSP 132 can be distributed outside the package of the processor 118, e.g., in its own package.

[0054] The auxiliary memory 120 can 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 main memory 128 for use by the processor 118, e.g., when performing the following operations: modulating the drive voltage to customize anti-adhesion vibration or determining the environmental conditions of the catheter fitting 108 based on sensor data when the catheter fitting 108 is placed in the vasculature. In fact, the multiple piezoelectric transducers 112 can be excited according to any mode or combination of modes selected from continuous mode, pulse mode, or burst mode, and the mode for exciting the multiple piezoelectric transducers 112 is stored in the auxiliary memory 120 for loading into the main memory 128 as needed for use by the processor 118 to prevent adhesion of thrombotic or non-thrombotic occlusions or to eliminate any existing accumulations.

[0055] The sensor interface 122 may include a signal conditioner 134 configured to standardize electrical signals from multiple 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 thus increase its signal-to-noise ratio.

[0056] The internal power source 106 may be configured to power the controller 104 and the multiple piezoelectric transducers 112. Such an internal power source 106 may be an internal battery, which may be capable of being charged through a port in the catheter bushing 102. Optionally, the internal battery is a lithium-ion battery, a button battery, or a flexible battery used with the remainder of the flexible electronics. Although the foregoing has been described, the internal power source 106 may alternatively be an external power source configured for wired or wireless power supply.

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

[0058] When the multiple piezoelectric transducers 112 are configured, in whole or in part, as multiple vibrators, the controller 104 may be configured to cause the multiple vibrators to vibrate 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 cause the multiple vibrators to vibrate at a frequency 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 cause the multiple vibrators to vibrate at a frequency within 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 multiple piezoelectric transducers 112 are all or partially configured as multiple vibrators, the controller 104 can be configured to vibrate the multiple 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 can be configured to vibrate the multiple vibrators with an amplitude not greater than about 100 μm, including not greater than about 10 μm, such as not greater than about 500 nm, for example, not greater than about 400 nm, 300 nm, 200 nm, 100 nm or 1 nm. For example, the controller 104 can be configured to vibrate the multiple vibrators with an amplitude in the range of about 1 nm to about 100 μm. It is noted that constructive interference of the superposition of vibration waves from at least adjacent piezoelectric transducers can advantageously increase the amplitude at one or more positions or specific sites along the length of the catheter fitting 108 as needed to inhibit the accumulation of thrombotic or non-thrombotic occlusions.

[0060] It is noted that the power consumption of the multiple piezoelectric transducers 112 depends on the combination of the size, vibration frequency, and vibration amplitude of the piezoelectric transducers, and can range from about 1 μW to about 100 mW.

[0061] Catheter assembly

[0062] Figure 4 Another catheter 138 for mechanically inhibiting occlusion formation according to some embodiments is shown, and Figure 5 A detailed view of a substrate 140 of a catheter fixing device 142 for the catheter 138 according to some embodiments is shown, and the catheter fixing device 142 includes a controller 104 and an internal power source 106 incorporated into the substrate 140. Figure 6 A catheter 138 fixed in the catheter fixing device 142 according to some embodiments is shown, thereby forming a catheter assembly 144 for mechanically inhibiting occlusion formation. Figure 7 Shown according to some embodiments Figure 6 of the catheter assembly 144.

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

[0064] Similar to the above catheter 100, Figure 4 and Figure 6The catheter 138 may include a catheter fitting 108, a catheter bushing 102, and one or more extension legs 110, which are coupled together in the foregoing order. Additionally, as described above, the catheter fitting 108 may include a plurality of piezoelectric transducers 112 along the length of the catheter fitting 108 and electrical leads 114. Different from the catheter 100 described above, the catheter 138 does not need to include a controller 104 or an internal power source 106, which are disposed in the catheter fixation device 142, as described below. Thus, the catheter 138 may be configured such that the suture wing through-holes 146 of the suture wings 116 include loop contacts 148, which are operably connected to the plurality of piezoelectric transducers 112 through the electrical leads 114 for powering the plurality of piezoelectric transducers 112 of the catheter fitting 108 and controlling the plurality of piezoelectric transducers.

[0065] As Figure 5 shown, the catheter fixation device 142 may include a pad 150 and a retainer 152 fixedly coupled together, and the catheter fixation device 142 is configured to fix the catheter 138 to a patient when the catheter fitting 108 of the catheter 138 is placed within the patient's vasculature.

[0066] The pad 150 may include a skin-facing side, and an adhesive is included on the skin-facing side for adhering the catheter fixation device 142 to the patient after removing the liner on the skin-facing side of the pad 150. The pad 150 may further include an exposed side opposite to the skin-facing side of the pad 150, and the retainer 152 is fixedly attached to the exposed side.

[0067] The retainer 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 source 106. In fact, as Figure 5As shown, both the controller 104 and the internal power supply 106 can be incorporated into the substrate 140 of the retainer 152; however, in some embodiments, the controller 104 and the internal power supply 106 can alternatively be distributed between the substrate 140 and the top cover 156. Whether the controller 104 and the internal power supply 106 are incorporated into the substrate 140, the top cover 156, or distributed between the substrate 140 and the top cover 156 of the catheter fixing device 142, the catheter fixing device 142 can include fixture-based electrical connectors in the substrate 140 or the top cover 156 for connecting to 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 catheter-based electrical connectors for connecting to the loop contacts 148 (as catheter-based electrical connectors) of the suture wings 116 of the catheter 138 to power and control the plurality of piezoelectric transducers 112 of the catheter fitting 108 of the catheter 138. Figure 5 and Figure 6 The top cover 156 shown in Figure 5 (which is formed by two movably hinged top cover parts) can be configured to cover the suture wings 116 of the catheter 138 and hold them in place on a pair of posts 154 extending from the substrate 140, thereby maintaining sufficient electrical contact for powering and controlling the plurality of piezoelectric transducers 112.

[0068] It is noted that while the catheter assembly 144 can include a plurality of piezoelectric transducers 112, a controller 104, and an internal power supply 106 distributed among the individual components of the catheter assembly 144 (i.e., distributed between the catheter 138 and the catheter fixing device 142), the catheter assembly 144 is not limited to the foregoing configuration. In fact, the controller 104 and the internal power supply 106 can alternatively be housed in an independent controller unit that is independent of the catheter fixing device 142. Such a controller unit can be configured with a plug for insertion into the port of the catheter bushing 102 of the catheter 138, and the controller unit can be easily replaced with another powered controller unit as needed to maintain mechanical inhibition of occlusion formation in the catheter fitting 108 of the catheter 138 with minimal interruption. That is, the plurality of piezoelectric transducers 112, the controller 104, and the internal power supply 106 can be incorporated into a single-component catheter assembly (such as the catheter 100 described above).

[0069] Method

[0070] The method can include methods of using and manufacturing the catheter 100 or the catheter assembly 144.

[0071] Methods of using catheter 100 or catheter assembly 144 can include one or more operations selected from resection operations, placement operations, fixation operations, power supply operations, and customization operations.

[0072] The resection operation can be performed before the placement operation, as the resection operation can include resection of the distal portion of catheter fitting 108 to achieve a desired placement length of catheter fitting 108. As described above, individually piezoelectric transducers, individual groups of piezoelectric transducers, or a combination of individually piezoelectric transducers and individual groups of piezoelectric transducers being individually electronically addressed allows the remaining piezoelectric transducers among the plurality of piezoelectric transducers 112 that are not resected with the distal portion of catheter fitting 108 to vibrate along the placement length of catheter fitting 108 according to being individually electronically addressed.

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

[0074] The fixation operation can include fixing catheter 100 or 138 to the patient. With respect to catheter 138, the fixation operation can include fixing catheter 138 in catheter fixation device 142, which can in turn include disposing suture wings 116 of catheter 138 above a pair of posts 154 extending from substrate 140 such that loop contacts 148 of suture wings 116 form sufficient electrical contact for powering and controlling the plurality of piezoelectric transducers 112. Additionally, the fixation operation can include covering suture wings 116 of catheter 138 to hold them in place on the pair of posts 154 and maintain electrical contact for powering and controlling the plurality of piezoelectric transducers 112.

[0075] The power supply operation can include powering catheter 100 or catheter assembly 144 through internal power source 106. Such power supply operation activates controller 104 including processor 118 and memory to control the plurality of piezoelectric transducers 112 to vibrate and thus inhibit the accumulation of biological materials on the inner lumen surface of catheter fitting 108, the distal inner lumen surface of catheter fitting 108, or both the inner lumen surface and the distal inner lumen surface of catheter fitting 108 by means of anti-adhesion vibration along the length of catheter fitting 108.

[0076] Custom operations can include imaging the catheter 100 or 138, such as via ultrasound, determining where a thrombotic or non-thrombotic occlusion is located within the catheter plumbing 108, and, in the presence of such an occlusion, applying a customized vibration where the thrombotic or non-thrombotic occlusion is located within the catheter plumbing 108. The customized vibration can be customized in terms of frequency, amplitude, or pulse waveform and can 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 within the catheter plumbing 108. Additionally, the burst mode described above can 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 the thrombotic or non-thrombotic occlusion located within the catheter plumbing 108. Advantageously, similar to any anti-adhesion vibration provided along the length of the catheter plumbing 108 described herein, such customized vibration can be restricted to the inner lumen surface or distal inner lumen surface of the catheter plumbing 108 as a surface wave thereon, thereby selectively targeting the inner lumen surface or distal inner lumen surface of the catheter plumbing 108 relative to the other.

[0077] Advantageously, once the catheter 100 or 138 is placed and the catheter 100 or catheter assembly 144 is powered according to the placement operation and power supply operation, respectively, no further clinician intervention (e.g., catheter flushing, antibiotic lock therapy, etc.) is required until the internal power source 106 is charged or replaced. Additionally, since the internal power source 106 obviates the need for the patient to be connected to an external power source, the patient can enjoy as much mobility as the patient is permitted to have.

[0078] Regarding methods of manufacturing the catheter 100 or catheter assembly 144, such methods can include one or more operations selected from manufacturing operations and assembly operations.

[0079] Manufacturing operations can include manufacturing flexible electronic devices on the inner lumen surface of the catheter fitting 108, manufacturing flexible electronic devices on the distal inner lumen surface of the catheter fitting 108, or disposing the flexible electronic devices between the inner lumen surface and the distal inner lumen surface of the catheter fitting 108. Such manufacturing of the flexible electronic devices can include using contact-type flexible electronic device manufacturing methods selected from screen printing, flexographic printing, gravure printing, and soft lithography. Alternatively, the manufacturing of the flexible electronic devices can include using non-contact-type flexible electronic device manufacturing methods selected from multiphoton lithography or direct laser writing lithography, aerosol printing, and inkjet printing. As set forth above for the flexible electronic devices manufactured on the inner lumen surface of the catheter fitting 108, the flexible electronic devices can be manufactured on or even as the tubular substrate, and the remaining portion of the catheter fitting 108 can be extruded or dip-coated thereon. And as set forth above for the flexible electronic devices disposed between the inner lumen surface and the distal inner lumen surface of the catheter fitting 108, the flexible electronic devices can be manufactured on the inner layer of the catheter fitting 108, and the outer layer of the catheter fitting 108 can be extruded or dip-coated thereon.

[0080] Assembly operations can include inserting or otherwise disposing the proximal portion of the catheter fitting 108 into the catheter bushing 102. Additionally, the assembly operations can include inserting or otherwise disposing the distal portion of each of one or more extension legs 110 into the catheter bushing 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 can be envisioned by those of ordinary skill in the art, and in a broader sense, these adaptations or modifications are also encompassed. Accordingly, changes can 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 catheter is a central venous catheter or a peripherally inserted central catheter.

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