Patent Application
20250072838
The foregoing applications are incorporated by reference herein in their entireties. To the extent the foregoing applications or any other material incorporated herein by reference conflicts with the present disclosure, the present disclosure controls.
The present technology relates to implantable medical devices and associated systems and methods of use. Particular embodiments of the present technology are directed to vascular access devices, systems, and methods.
Vascular access devices (e.g., vascular access ports) are minimally invasive, surgically implanted devices that provide relatively quick and easy access to a patient's central venous system for the purpose of administering intravenous medications, such as chemotherapeutic agents. Conventional vascular access devices are commonly used for patients requiring frequent, repeated intravenous administration of therapeutic agents or fluid, repeated blood draws, and/or for patients with difficult vascular access.
Vascular access devices such as vascular access ports typically include a reservoir attached to a catheter. The entire unit is placed completely within a patient's body using a minimally invasive surgical procedure. In most cases, the reservoir is placed in a small pocket created in the upper chest wall just inferior to the clavicle, and the catheter is inserted into the internal jugular vein or the subclavian vein with the tip resting in the superior vena cava or the right atrium. However, such vascular access devices can be placed in other parts of the body and/or with the catheter positioned in alternative sites as well. In conventional devices, the reservoir is typically bulky such that the overlying skin protrudes, allowing a clinician to use palpation to localize the device for access when it is to be used for a medication infusion or aspiration of blood for testing. A self-sealing cover (e.g., a thick silicone membrane) is disposed over and seals the reservoir, allowing for repeated access using a non-coring (e.g., Huber type) needle that is inserted through the skin and into the port. This access procedure establishes a system in which there is fluid communication between the needle, the vascular access device, the catheter, and the vascular space, thereby enabling infusion of medication or aspiration of blood via a transcutaneous needle.
Conventional vascular access devices are bulky by design to allow a clinician to localize the device by palpation. To be accurately accessed by a clinician, the vascular access device needs to be either visualized or palpated under the skin. Additionally, conventional vascular access ports have no electronic components and no internal power source. Accordingly, there is a need for improved vascular access devices.
The subject technology is illustrated, for example, according to various aspects described below, including with reference to
1. A vascular access device comprising:
2. The vascular access device of Clause 1, wherein the data communications module is carried by the housing of the hub.
3. The vascular access device of Clause 1 or Clause 2, wherein the sensing element is configured to communicate with the data communications module via a wireless connection.
4. The vascular access device of Clause 1 or Clause 2, further comprising a conductive element having a first portion electrically coupled to the sensing element and a second portion electrically coupled to the data communications module.
5. The vascular access device of Clause 4, wherein the conductive element and catheter are coextruded.
6. The vascular access device of Clause 4 or Clause 5, wherein the conductive element is at least partially positioned within a sidewall of the catheter.
7. The vascular access device of any one of Clauses 4 to 6, wherein the catheter comprises a channel that is radially offset from the lumen, and wherein the conductive element is positioned within the channel.
8. The vascular access device of any one of Clauses 1 to 7, further comprising a battery in electrical communication with the sensing element.
9 The vascular access device of any one of Clauses 1 to 8, wherein the sensing element is at least partially positioned within a sidewall of the catheter.
10. The vascular access device of any one of Clauses 1 to 9, wherein the sensing element is at least partially exposed to the lumen of the catheter and/or an environment surrounding the catheter.
11. The vascular access device of any one of Clauses 1 to 10, wherein the lumen is a first lumen, the catheter having a second lumen radially offset from the first lumen.
12. The vascular access device of Clause 11, wherein the sensing element is positioned within the second lumen.
13. The vascular access device of Clause 11 or Clause 12, wherein the first lumen is fluidically isolated from the second lumen.
14. The vascular access device of any one of Clauses 1 to 13, wherein the physiological parameter of the patient comprises at least one of a heart rate of the patient, a central venous pressure of the patient, a respiratory rate of the patient, a respiratory sound of the patient, a cardiac sound of the patient, a gastrointestinal sound of the patient, a speech of the patient, a core temperature of the patient, an electrical signal of a heart of the patient, an activity level of the patient, a blood oxygenation of the patient, or a blood glucose of the patient.
15. The vascular access device of any one of Clauses 1 to 14, wherein the performance parameter of the vascular access device comprises at least one of a flow rate within the lumen of the catheter, a pressure in the lumen of the catheter, a temperature of the catheter, an electrical impedance of the sensing element, or a charge level of a battery of the device.
16. A vascular access device comprising:
17. The vascular access device of Clause 16, wherein the distal end portion of the catheter is configured to be cut to be separated from the intermediate portion of the catheter.
18. The vascular access device of Clause 16 or Clause 17, wherein the catheter comprises one or more markers configured to indicate a location of at least one of the intermediate portion of the catheter or the distal end portion of the catheter.
19. The vascular access device of Clause 18, wherein the one or more markers comprise at least one of a film, a coating, a surface treatment, a recess, an opening, or a protrusion.
20. The vascular access device of Clause 18 or Clause 19, wherein the one or more markers comprise at least one of a number, a letter, a color, a symbol, a pattern, or a shape.
21. A vascular access device for implanting into a body of a patient, the vascular access device comprising:
22. The vascular access device of Clause 21, the intermediate portion further comprising a data communications module communicatively coupled to the sensing element.
23. The vascular access device of Clause 21 or Clause 22, further comprising a data communications module carried by the hub and configured to communicate wirelessly with an external computing device.
24. The vascular access device of Clause 22 or Clause 23, wherein the data communications module is communicatively coupled to the sensing element via a conductive element.
25. The vascular access device of Clause 24, wherein the conductive element has a proximal end portion configured to be electrically coupled to the data communications module and a distal end portion configured to be electrically coupled to the sensing element.
26. The vascular access device of Clause 24 or Clause 25, wherein a first portion of the conductive element is positioned within the sidewall of the catheter and a second portion of the conductive element extends away from the sidewall of the catheter.
27. The vascular access device of Clause 26, wherein the conductive element extends from the first portion within the sidewall to the second portion through an aperture in the sidewall.
28. The vascular access device of Clause 26 or Clause 27, wherein the first portion is the distal end portion of the conductive element, and the second portion is the proximal end portion of the conductive element.
29. The vascular access device of any one of Clauses 25 to 28, wherein the proximal end portion of the conductive element is configured to be electrically coupled to the data communications module via an electrical connector carried by the housing of the hub.
30. A vascular access system comprising:
31. The vascular access system of Clause 30, wherein the physiological parameter comprises at least one of a heart rate, a heart rhythm, a respiratory rate, a pulmonary function testing parameter, a breath sound, a heart sound, an abdominal sound, or a vocal sound.
32. The vascular access system of Clause 30 or Clause 31, further comprising a data communications module communicatively coupled to the sensing element and configured to transmit the data obtained by the sensing element to an external computing device.
33. The vascular access system of any one of Clauses 30 to 32, wherein the controller is carried by the hub.
34. The vascular access system of any one of Clauses 30 to 32, wherein the controller is separate from the hub.
35. The vascular access system of Clause 34, wherein the controller is configured to be extracorporeally positioned when the hub is implanted.
36. The vascular access system of any one of Clauses 30 to 35, wherein the system further comprises an electronics component carried by the hub.
37. The vascular access system of any one of Clauses 30 to 36, wherein the sensing element is a microphone.
38. The vascular access system of any one of Clauses 30 to 37, wherein the sensing element comprises a plurality of microphones.
Many aspects of the present disclosure can be better understood with reference to the following drawings. The components in the drawings are not necessarily to scale. Instead, emphasis is placed on illustrating clearly the principles of the present disclosure.
The present technology relates to implantable medical devices such as vascular access devices and associated systems and methods of use. Specific details of several embodiments of the technology are described below with reference to
The vascular access devices and systems of the present technology may be equipped with electronic components that provide a platform for remote monitoring of the device and/or patient. For example, several of the vascular access devices disclosed herein include a sensing element configured to obtain data characterizing a patient's health, performance of the device, treatment status, and/or other parameters for enhancing patient care. According to some embodiments, a vascular access device can include a sensing element configured to obtain patient physiological data while the vascular access device is implanted within the patient, and determine one or more physiological parameters based on the data. The system may determine certain physiological parameters, for example, that indicate one or more symptoms of a medical condition that requires immediate medical attention or hospitalization. Such physiological parameters can include those related to temperature, patient movement/activity level, heart rate, respiratory rate, blood oxygen saturation, and/or other suitable parameters described herein. Additionally or alternatively, the systems of the present technology can be configured to determine one or more device performance parameters. For example, a vascular access device can include a sensing element configured to obtain data characterizing a flow rate within the device and, based on the data, the system can determine if the device is occluded and/or the extent of the occlusion.
According to various embodiments of the present technology, a vascular access device comprises a hub including a fluid reservoir and a catheter configured to be secured to the hub and fluidically coupled to the reservoir. The vascular access device can include one or more sensing elements carried by the hub and/or one or more sensing elements carried by the catheter. As detailed herein, a sensing element carried by the catheter may be configured to obtain data characterizing certain device parameters and/or physiological parameters and transmit the data to the hub and/or an extracorporeal location (e.g., to an interrogation device, a remote computing device, etc.) for storage and/or further processing. Catheter-level sensing can be particularly beneficial for measuring physiological parameters, as catheters can access more distal and/or central locations within the patient's heart and vasculature and thus provide greater accuracy for certain measurements, such as core temperature, central venous pressure, heart rate, etc. Additionally or alternatively, a sensing element carried by the catheter can be configured to obtain data characterizing catheter performance, as described in greater detail herein.
As shown schematically in
The system 10 may further include first remote computing device(s) 160 (or server(s)), and the local computing device 150 may in turn be in communication with first remote computing device(s) 160 over a wired or wireless communications link (e.g., the Internet, public and private intranet, a local or extended Wi-Fi network, cell towers, the plain old telephone system (POTS), etc.). The first remote computing device(s) 160 may include one or more own processor(s) and memory. The memory may be a tangible, non-transitory computer-readable medium configured to store instructions executable by the processor(s). The memory may also be configured to function as a remote database, i.e., the memory may be configured to permanently or temporarily store data received from the local computing device 150 (such as one or more physiological measurements or parameters and/or other patient information).
In some embodiments, the first remote computing device(s) 160 can additionally or alternatively include, for example, server computers associated with a hospital, a medical provider, medical records database, insurance company, or other entity charged with securely storing patient data and/or device data. At a remote location 170 (e.g., a hospital, clinic, insurance office, medical records database, operator's home, etc.), an operator may access the data via a second remote computing device 172, which can be, for example a personal computer, smart device (e.g., a smartphone, a tablet, or other handheld device having a processor and memory), or other suitable device. The operator may access the data, for example, via a web-based application. In some embodiments, the obfuscated data provided by the device 100 can be de-obfuscated (e.g., unencrypted) at the remote location 170.
In some embodiments, the device 100 may communicate with remote computing devices 160 and/or 172 without the intermediation of the local computing device 150. For example, the vascular access device 100 may be connected via Wi-Fi or other wireless communications link to a network such as the Internet. In other embodiments, the device 100 may be in communication only with the local computing device 150, which in turn is in communication with remote computing devices 160 and/or 172.
The hub 202 may comprise a housing 208, a fluid reservoir 210 contained within the housing 208, and a septum 212 adjacent the reservoir 210 that is configured to receive a needle therethrough for delivery of a fluid (such as a therapeutic or diagnostic agent) to the reservoir 210. The housing 208 may be made of a biocompatible plastic, metal, ceramic, medical grade silicone, or other material that provides sufficient rigidity and strength to prevent inadvertent needle puncture through the housing 208. The septum 212 can be, for example, a self-sealing membrane made of silicone or other deformable, self-sealing, biocompatible material.
The catheter 600 can be configured to permanently or detachably couple to the hub 202 to be placed into fluid communication with the reservoir 210. For example, as shown in
As shown in
As shown in
The catheter 600 can have different lengths depending on the desired positioning of the distal end portion 600b of the catheter 600, such as within the superior vena cava SVC, the right atrium RA, the inferior vena cava IVC, or another suitable cardiovascular location.
In some embodiments, for example as shown in
Referring back to
The controller may also include a data communications unit configured to securely transmit data between the device 200 and external computing devices (e.g., local computing device 150, remote computing devices 160 and 172, etc.). In some embodiments, the controller includes a localization unit configured to emit a localization signal (e.g., lights that transilluminate a patient's skin, vibration, a magnetic field, etc.) to aid a clinician in localizing the device 200 when implanted within a patient. The controller can also include a wireless charging unit (such as a coil) configured to recharge a battery (not shown) of the device 200 when in the presence of an interrogation device (e.g., local device 150 or another suitable device).
The system 10 may be configured to continuously and/or periodically obtain measurements via the sensing element 204. The sensing element 204 may be carried by the housing 208 and/or the catheter 600, and/or may include a sensing component separate from the housing 208 and catheter 600 but physically or wirelessly communicatively coupled to the housing 208 and/or catheter 600. The sensing element 204 may be implanted at the same location as the device 200 or at a different location, or may be positioned on the patient at an exterior location (e.g., on the patient's skin). The sensing element 204 may be permanently coupled to the device 200, or may be configured to temporarily couple to the device 200.
In some embodiments, the sensing element 204 is built into the housing 208 and/or the catheter 600 such that only a portion of the sensing element 204 is exposed to the local physiological environment when the device 200 is implanted. For example, the sensing element 204 may comprise one or more electrodes having an external portion positioned at an exterior surface of the housing 208 and/or the catheter 600 and an internal portion positioned within the housing 208 and/or the catheter 600 and, optionally, wired to the controller. In some embodiments, the sensing element 204 may comprise one or more electrodes having an internal portion positioned at an interior surface of the housing 208 at the interface with the port reservoir 210 or junction of the reservoir 210 and the catheter 600, or extending into the catheter 600.
In some embodiments the sensing element 204 may be completely contained within the housing 208 and/or the catheter 600. For example, the sensing element 204 may comprise one or more pulse oximeters enclosed by the housing 208 and/or the catheter 600 and positioned adjacent a window in the housing 208 and/or the catheter 600 through which light emitted from the pulse oximeter may pass to an external location, and back through which light reflected from the external location may pass for detection by a photodiode of the pulse oximeter. In such embodiments the window may be, for example, a sapphire window that is brazed into place within an exterior wall of the housing 208 and/or the catheter 600.
The sensing element 204 may comprise at least one sensor completely enclosed by the housing 208 and/or the catheter 600 and at least one sensor that is partially or completely positioned at an external location, whether directly on the housing 208 and/or catheter 600 or separated from the housing 208 and/or catheter 600 (but still physically coupled to the housing 208 and/or catheter 600 via a wired connection, for example). In some embodiments, at least a portion of the sensing element 204 is positioned at and/or exposed to an interior region of the reservoir 210. In some embodiments, at least a portion of the sensing element 204 is positioned at and/or exposed to a lumen of the catheter 600.
The sensing element 204 and/or electronic component 206 can be mounted to one or both sides of a PCB. The hub 202 and/or the catheter 600 can carry a PCB mounting one sensing element 204, a PCB mounting one electronic component 206, a PCB mounting multiple sensing elements 204 and/or a PCB mounting multiple electronic components 206. Although
In some embodiments, the sensing element 204 may include a separate controller (not shown) that comprises one or more processors and/or software components. In such embodiments, the sensing element 204 may process at least some of the measurements to determine one or more parameters, and then transmit those parameters to the controller of the device 200 (with or without the underlying data). In some examples, the sensing element 204 may only partially process at least some of the measurements before transmitting the data to the controller. In such embodiments, the controller may further process the received data to determine one or more parameters. The local computing device 150 and/or the remote computing devices 160, 172 may also process some or all of the measurements obtained by the sensing element 204 and/or parameters determined by the sensing element 204 and/or the controller.
According to some aspects of the technology, the sensing element 204 may include memory. The memory may be a non-transitory computer-readable medium configured to permanently and/or temporarily store the measurements obtained by the sensing element 204. In those embodiments where the sensing element 204 includes its own processor(s), the memory may be a tangible, non-transitory computer-readable medium configured to store instructions executable by the processor(s).
In some embodiments, the sensing element(s) 204 and/or controller may be configured to detect, identify, monitor, and/or communicate information by electromagnetic, acoustic, motion, optical, thermal, or biochemical sensing elements or means. The sensing element(s) 204 may include, for example, one or more temperature sensing elements (e.g., one or more thermocouples, one or more digital temperature sensors, one or more thermistors or other type of resistance temperature detector, etc.), one or more impedance sensing elements (e.g., one or more electrodes), one or more pressure sensing elements, one or more optical sensing elements, one or more flow sensing elements (e.g., a Doppler velocity sensing element, an ultrasonic flow meter, etc.), one or more ultrasonic sensing elements, one or more photoplethysmography (PPG) sensing elements (e.g., pulse oximeters, etc.), one or more chemical sensing elements, one or more movement sensing elements (e.g., one or more accelerometers), one or more pH sensing elements, an electrocardiogram (“ECG” or “EKG”) unit, one or more electrochemical sensing elements, one or more hemodynamic sensing elements, and/or other suitable sensing devices.
The sensing element 204 may comprise one or more electromagnetic sensing elements configured to measure and/or detect, for example, impedance, voltage, current, or magnetic field sensing capability with a wire, wires, wire bundle, magnetic node, and/or array of nodes. The sensing element 204 may comprise one or more acoustic sensing elements configured to measure and/or detect, for example, sound frequency, within human auditory range or below or above frequencies of human auditory range, beat or pulse pattern, tonal pitch melody, and/or song. The sensing element 204 may comprise one or more motion sensing elements configured to measure and/or detect, for example, vibration, movement pulse, pattern or rhythm of movement, intensity of movement, and/or speed of movement. Motion communication may occur by a recognizable response to a signal. This response may be by vibration, pulse, movement pattern, direction, acceleration, or rate of movement. Motion communication may also be by lack of response, in which case a physical signal, vibration, or bump to the environment yields a motion response in the surrounding tissue that can be distinguished from the motion response of the sensing element 204. Motion communication may also be by characteristic input signal and responding resonance. The sensing element 204 may comprise one or more optical sensing elements which may include, for example, illuminating light wavelength, light intensity, on/off light pulse frequency, on/off light pulse pattern, passive glow or active glow when illuminated with special light such as UV or “black light”, or display of recognizable shapes or characters. It also includes characterization by spectroscopy, interferometry, response to infrared illumination, and/or optical coherence tomography. The sensing element 204 may comprise one or more thermal sensing elements configured to measure and/or detect, for example, device 200 temperature relative to surrounding environment, the temperature of the device 200 (or portion thereof), the temperature of the environment surrounding the device 200 and/or sensing element 204, or differential rate of the device temperature change relative to surroundings when the device environment is heated or cooled by external means. The sensing element 204 may comprise one or more biochemical devices which may include, for example, the use of a catheter, a tubule, wicking paper, or wicking fiber to enable micro-fluidic transport of bodily fluid for sensing of protein, RNA, DNA, antigen, and/or virus with a micro-array chip.
In some aspects of the technology, the controller and/or sensing element 204 may be configured to detect and/or measure the concentration of blood constituents, such as sodium, potassium, chloride, bicarbonate, creatinine, blood urea nitrogen, calcium, magnesium, and phosphorus. The system 10 and/or the sensing element 204 may be configured to evaluate liver function (e.g., by evaluation and/or detection of AST, ALT, alkaline phosphatase, gamma glutamyl transferase, troponin, etc.), heart function (e.g., by evaluation and/or detection of troponin), coagulation (e.g., via determination of prothrombin time (PT), partial thromboplastin time (PTT), and international normalized ratio (INR)), and/or blood counts (e.g., hemoglobin or hematocrit, white blood cell levels with differential, and platelets). In some embodiments, the system 10 and/or the sensing element 204 may be configured to detect and/or measure circulating tumor cells, circulating tumor DNA, circulating RNA, multigene sequencing of germ line or tumor DNA, markers of inflammation such as cytokines, C reactive protein, erythrocyte sedimentation rate, tumor markers (PSA, beta-HCG, AFP, LDH, CA 125, CA 19-9, CEA, etc.), and others.
As previously mentioned, the system 10 may determine one or more physiological parameters based on data obtained by the sensing element 204 and/or one or more other physiological parameter(s). For example, the system 10 may be configured to determine physiological parameters such as heart rate, temperature, blood pressure (e.g., systolic blood pressure, diastolic blood pressure, mean arterial blood pressure), cardiac output, ejection fraction, pulmonary artery pressure, pulmonary capillary wedge pressure, left atrial pressure, blood flow rate, blood velocity, pulse wave speed, volumetric flow rate, reflected pressure wave amplitude, augmentation index, flow reserve, resistance reserve, resistive index, capacitance reserve, hematocrit, heart rhythm, electrocardiogram (ECG) tracings, body fat percentage, activity level, body movement, falls, gait analysis, seizure activity, blood glucose levels, drug/medication levels, blood gas constituents and blood gas levels (e.g., oxygen, carbon dioxide, etc.), lactate levels, hormone levels (such as cortisol, thyroid hormone (T4, T3, free T4, free T3), TSH, ACTH, parathyroid hormone), medication concentration in the blood, pharmacokinetic and pharmacodynamic data, and/or any correlates and/or derivatives of the foregoing measurements and parameters (e.g., raw data values, including voltages and/or other directly measured values). In some embodiments, data obtained by the sensing element 204 can be utilized or characterized as a physiological parameter without any additional processing by the system 10.
Additionally or alternatively, the sensing element 204 can be configured to obtain data characterizing a parameter associated with performance of the device, treatment of the patient, etc. For example, the sensing element 204 can be configured to obtain data characterizing a flow rate parameter within the catheter 600 and/or the reservoir 210, a pressure within the catheter 600 and/or the reservoir 210, a temperature of one or more portions of the device 200, a presence and/or position of an object (e.g., a needle, fluid, a clot, etc.) within the reservoir 210 and/or catheter 600, information encoded by machine-readable indicia, etc.
The system 10 may also determine and/or monitor derivatives of any of the foregoing parameters (e.g., physiological parameters, device performance parameters, treatment parameters, identity parameters, etc.), such as a rate of change of a particular parameter, a change in a particular parameter over a particular time frame, etc. As but a few examples, the system 10 may be configured to determine a temperature over a specified time, a maximum temperature, a maximum average temperature, a minimum temperature, a temperature at a predetermined or calculated time relative to a predetermined or calculated temperature, an average temperature over a specified time, a maximum blood flow, a minimum blood flow, a blood flow at a predetermined or calculated time relative to a predetermined or calculated blood flow, an average blood flow over time, a maximum impedance, a minimum impedance, an impedance at a predetermined or calculated time relative to a predetermined or calculated impedance, a change in impedance over a specified time, a change in impedance relative to a change in temperature over a specified time, a change in heart rate over time, a change in respiratory rate over time, activity level over a specified time and/or at a specified time of day, and other suitable derivatives.
Data may be obtained continuously or periodically at one or more predetermined times, ranges of times, calculated times, and/or times when or relative to when a measured event occurs. Likewise, parameters (physiological or otherwise) may be determined continuously or periodically at one or more predetermined times, ranges of times, calculated times, and/or times when or relative to when a measured event occurs.
Based on the determined parameters, the system 10 of the present technology can be configured to provide an indication of the patient's health, the performance and/or health of device, and/or the status of a treatment to the patient and/or a clinician. For example, the controller may compare one or more physiological parameters to a predetermined threshold or range and, based on the comparison, provide an indication of the patient's health. If the determined physiological parameter(s) is above or below the predetermined threshold or outside of the predetermined range, the system 10 may provide an indication that the patient is at risk of, or has already developed, a medical condition characterized by symptoms associated with the determined physiological parameters. As used herein, a “predetermined range” refers to a set range of values, and “outside of a/the predetermined range” refers to (a) a measured or calculated range of values that only partially overlap the predetermined range or do not overlap any portion of a predetermined range of values. As used herein, a “predetermined threshold” refers to a single value or range of values, and a parameter that is “outside” of “a predetermined threshold” refers to a situation where the parameter is (a) a measured or calculated value that exceeds or fails to meet a predetermined value, (b) a measured or calculated value that falls outside of a predetermined range of values, (c) a measured or calculated range of values that only partially overlaps a predetermined range of values or does not overlap any portion of a predetermined range of values, or (d) a measured or calculated range of values where none of the values overlap with a predetermined value.
Predetermined parameter thresholds and/or ranges can be empirically determined to create a look-up table. Look-up table values can be empirically determined, for example, based on clinical studies and/or known healthy or normal values or ranges of values. The predetermined threshold may additionally or alternatively be based on a particular patient's baseline physiological parameters, a particular device's baseline performance parameters, etc. In some embodiments, the system 10 can be configured to determine the predetermined threshold and/or range based on data collected by the device to determine a patient's normal or baseline parameter or range of parameters. In some cases, a patient's baseline parameter or range of parameters may differ from known normal parameters/ranges of parameters. For example, a patient with anemia may have a lower baseline blood oxygenation saturation than a non-anemic patient. Accordingly, a predetermined threshold for blood oxygenation saturation that indicates that the patient's blood oxygenation saturation is abnormal and/or indicative of a medical condition may be lower for the anemic patient than for a non-anemic patient.
In some embodiments, the controller may be configured to detect a pattern of measurements (of a single parameter or a combination of parameters) indicative of a health condition. In such embodiments, the individual measurements may not fall outside of a given “normal” range yet, when considered together, can still indicate a change in health status. For example, the controller may be configured to identify patterns of change in temperature, heart rate, and activity that are associated with infection, even if all three are still within a “normal” range.
Medical conditions detected and/or indicated by the system 10 may include, for example, sepsis, pulmonary embolism, metastatic spinal cord compression, anemia, dehydration/volume depletion, vomiting, pneumonia, congestive heart failure, performance status, arrythmia, neutropenic fever, acute myocardial infarction, pain, opioid toxicity, nicotine or other drug addiction or dependency, hyperglycemic/diabetic ketoacidosis, hypoglycemia, hyperkalemia, hypercalcemia, hyponatremia, one or more brain metastases, superior vena cava syndrome, gastrointestinal hemorrhage, immunotherapy-induced or radiation pneumonitis, immunotherapy-induced colitis, diarrhea, cerebrovascular accident, stroke, pathological fracture, hemoptysis, hematemesis, medication-induced QT prolongation, heart block, tumor lysis syndrome, sickle cell anemia crisis, gastroparesis/cyclic vomiting syndrome, hemophilia, cystic fibrosis, chronic pain, volume overload, hyperuricemia, and/or seizure. Any of the systems and/or devices disclosed herein may be used to monitor a patient for any of the foregoing medical conditions.
The system 10 can be configured to provide notifications to a patient and/or a clinician. For example, the device 100 and/or an external computing device (e.g., a smartphone, a PC, etc.) can be configured to provide a notification to the patient if a battery carried by the device 100 is low and needs to be recharged. The system 10 may be configured to provide a notification to a patient and/or clinician if it determines that the device is occluded, overheating, has lost wireless communication, is infected or colonized, or is otherwise malfunctioning. In some embodiments, the device 100 includes a notification unit configured to provide notifications to the patient without the need for an external computing device. The notification unit can include a speaker, a light, a vibration element, or another means for providing audible, visual, haptic, and/or tactile notifications to the patient. As an example, the notification unit can comprise a vibration element configured to vibrate if the patient's blood glucose has fallen outside of predetermined healthy or normal range to indicate to the patient that intervention should be taken to regulate their blood glucose.
In some embodiments, one or more parameters of a notification provided by a notification unit can be based on a type of information to be communicated to a patient. For example, a high frequency, high amplitude vibration can communicate to the patient that their blood pressure is higher than a predetermined threshold, while a low frequency, low amplitude vibration can communicate to the patient that their blood pressure is lower than a predetermined threshold. Further, various notification modalities and/or parameters can be used alone or in combination to communicate specific information to the patient. For example, the notification unit can include an LED light and a speaker. If the system 10 determines that the patient is experiencing ventricular fibrillation, the LED light can emit red light and the speaker can emit an audible notification instructing listeners to call an ambulance. In some embodiments, the LED light can emit a light of a specific color to indicate that the device 100 needs to be recharged.
According to various embodiments of the present technology, the device 100 can comprise a voice recognition unit configured to obtain audio data. The voice recognition unit can include a microphone, such as any of the microphones described herein, and a controller communicatively coupled to the microphone. In some embodiments, the voice recognition unit or one or more portions thereof is communicatively coupled to the sensing element 102 or another electronic component carried by the device 100. In some embodiments, the voice recognition unit comprises a microphone communicatively coupled to a separate controller carried by device 100 and/or an external controller.
The voice recognition unit can be configured to obtain audio data and, in some embodiments, transmit the audio data to the controller and/or sensing element 102. In some embodiments, the controller can be configured to cause the device 100 to perform a function or action, based at least in part on the audio data. For example, a person (e.g., a patient, a clinician, etc.) can provide an audible instruction for the device 100 to obtain data characterizing a temperature of the person. Providing the audible instruction can include saying out loud “Device, take the patient's temperature.” The voice recognition unit can obtain audio data characterizing the sound waves produced by the person providing the audible instruction. The audio data can be transmitted to a controller, which can process the audio data and, based on the audio data, cause the sensing element 102 carried by the device 100 to obtain data characterizing a temperature of the patient. In some embodiments, the controller can process the temperature data and/or cause the notification unit to provide a notification communicating the patient's temperature. In another example, a person can provide an audible instruction for the device 100 to turn on, wake up, exit a lower-power mode, or otherwise activate.
As previously noted, a vascular access device of the present technology can include a catheter carrying a sensing element, whose positioning can facilitate and/or enable collection of specific data by the sensing element. For example, a photoelectric sensing element configured to emit light into a lumen of the catheter and detect light reflected by the contents of the lumen can be carried by the catheter such that the sensor is exposed to the lumen of the catheter (e.g., directly, via a window, etc.) to permit the intended emission and detection of light. A sensing element carried by the catheter can be configured to obtain data characterizing a performance of the catheter. For example, a catheter can become obstructed if a blood clot forms in, on, or at the distal end of the catheter, which can hinder or prevent fluid delivery and/or aspiration through the device. A catheter of the present technology can carry a sensing element configured to measure a flow rate within the catheter, a pressure within the catheter, or another parameter such that the system is configured to evaluate a performance and/or functioning of the catheter. Additionally or alternatively, a sensing element carried by the catheter can be configured to be positioned distal of a hub of the vascular access device, which can enhance performance of the sensing element. For example, a central venous pressure measurement can be obtained with a greater accuracy by obtaining the measurement from a sensing element positioned in one of the venae cavae near the right atrium of the heart instead of a sensing element positioned at a proximal location in the superior vena cava.
A sensing element carried by a catheter can be configured to communicate with one or more data communications units and/or one or more remote computing devices. In some embodiments, a sensing element carried by a catheter can be configured to communicate with one or more electronic components (e.g., one or more additional sensing elements, one or more controllers, etc.) carried by the hub of the vascular access device. As described in greater detail below, a sensing element carried by a catheter can be configured to communicate via a wired connection or a wireless connection.
In
According to several embodiments, the catheter can include a sensing element configured to charge and/or communicate via a wired connection.
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As previously described, and as shown in
The catheter 1410 can be configured to be secured to the outlet port 1406 such that the conductive element 1416 is, either directly or indirectly, electrically coupled to the electronic component 1418 carried by the housing 1402. For example, the outlet port 1406 can comprise an electrically conductive material. The entire outlet port 1406 can comprise the electrically conductive material or the outlet port 1406 can comprise distinct regions of electrically conductive material. As shown in
As described herein, a catheter in accordance with several embodiments of the present technology can carry one or more sensing elements configured to detect a physiological parameter.
In some embodiments, for example as shown in
The sensing element 1606 can have any suitable two-dimensional shape (e.g., circular, triangular, hexagonal, etc.) or three-dimensional shape (e.g., cuboidal, spherical, cylindrical, conica, prismatic, toroidal, etc.). In these and other embodiments, a position of the sensing element 1606 on the catheter 1600 can be defined by points or edges forming a perimeter of the sensing element 1606, by a central point of a surface of the sensing element 1606, or by a central point within a volume of the sensing element 1606.
Although
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In contrast to the catheter 1800 and sensing element 1810 of
The sensing elements 1710, 1810, and 1910 are each depicted as having a thickness (as defined with reference to
A spacing of the sensing elements 2510 with respect to the proximal end portion 2500a and/or distal end portion 2500b of the catheter 2500 can be selected based on the physiological parameter(s) to be detected by the sensing elements 2510. For example, it may be advantageous for a sensing element 2510 configured to detect a core temperature of a patient to be located as close to the distal terminus of the catheter 2500 as possible so that, when the device is implanted, the sensing element 2510 is located as centrally within the patient as possible. In some embodiments, spacing of the sensing elements 2510 relative to one another, a spacing of a sensing element 2510 relative to a reference on the device (e.g., a proximal or distal terminus of the catheter 2500, etc.), and/or a position of a sensing element 2510 relative to the patient's anatomy can be based on a desired performance of the sensing elements 2510. For example, it may be advantageous for sensing elements 2510 that are configured to detect an electrical signal of the patient's heart (e.g., EKG electrodes, etc.) to be spaced apart by no less than a predetermined threshold to ensure an electrical signal detected by the sensing elements 2510 is of sufficient quality.
As previously noted, in some embodiments it may be advantageous for sensing elements carried by a catheter of a vascular access device to be located at specific positions based on the patient's anatomy, a desired performance of the sensors, or another design consideration. For example, it may be advantageous for a sensing element configured to detect a central venous pressure of a patient to be located within at least one of the venae cavae and as close to the right atrium of the heart as possible. Accordingly, a vascular access device of the present technology can be configured such that, when the device is implanted, a central venous pressure sensing element is positioned within the superior vena cava or the inferior vena cava at a location as close to the right atrium as possible. In some embodiments, this can be ensured by spacing such a sensing element apart from the proximal terminus of the catheter and/or the housing defining the reservoir by a specific distance.
Additionally, it is often the case that the distal tip of a catheter of a vascular access device should be located at a specific position for delivery of medication and/or withdrawal of fluid samples via the device. For example, as noted with regards to
Despite the importance of precise and accurate positioning of the catheter and sensing elements within a patient, such positioning can be challenging to achieve. Patients have variable anatomy and the distance between the pocket in the upper chest wall where the hub is to be positioned and the desired location of the distal tip of the catheter or the desired location of the sensing element may differ across patients. Accordingly, even if two hubs are implanted at the exact same location in two different patients, the distal tip of the catheter and the sensing elements may be located at different positions within each of the patient's vasculature.
To address the above-noted needs and challenges, a vascular access device of the present technology can comprise a catheter whose length can be modified such that, when the device is implanted in a patient, the sensing element(s) are positioned at desired locations relative to the patient's anatomy.
In some embodiments, a sidewall 2610 of the catheter 2604 can include one or more markers 2612 configured to indicate information regarding the location of the sensing element 2606 and/or a desired length of the catheter 2604. For example,
As shown in
In some embodiments, the device 2600 can be provided to a user in a pre-assembly configuration in which the catheter 2604 is not fixedly secured to the hub 2602. In such embodiments, the proximal end portion 2604a and/or the distal end portion 2604b of the catheter 2604 can be trimmed, cut, or otherwise modified and the catheter 2604 can be secured to the hub 2602 after modifying either end of the catheter 2604. However, in some embodiments the device 2600 can be provided to a user in an assembled configuration in which the proximal end portion 2604a of the catheter 2604 is fixedly secured to the hub 2602. In such embodiments, the distal end portion 2604b of the catheter 2604 can be modified, but not the proximal end portion 2604a.
As previously noted, a catheter of the present technology can carry one or more electrical components, such as a sensing element, configured to communicate with other electrical components via a wired connection. For example, as described with reference to
The conductive element 2710 can have a distal end portion electrically coupled to the sensing element 2706 and a proximal end portion electrically coupled to the connector 2712. The distal portion of the conductive element 2710 can be coextruded with a sidewall of the catheter 2704, positioned within a lumen and/or channel of the catheter 2704, etc. Additionally or alternatively, the conductive element 2710 can have a proximal portion that is separate from the catheter 2704 (see
According to various embodiments, for example as shown in
The distinct nature of the electronics module 2806 and catheter 2804 can facilitate and/or enable modifications of the length of the catheter 2804. For example, in some embodiments the proximal end portion 2804a and/or the distal end portion 2804b of the catheter 2804 can be cut or otherwise modified prior to securing of the electronics module 2806 to the catheter 2804. In some embodiments, the electronics module 2806 can be secured to the distal end portion 2804b of the catheter 2804 prior to trimming of the catheter 2804, such that only the proximal end portion 2806a of the catheter 2804 can be trimmed once the module 2806 and catheter 2804 have been secured.
The electronics module 2806 can include one or more electronic components 2812 including, but not limited to, a sensing element, a controller, memory, a data communications unit, or a power source. If the electronics module 2806 includes multiple electronic components 2812, these components can be communicatively coupled to one another via a wired or wireless connection. Additionally or alternatively, one or more of the electronic components 2812 can be configured to wirelessly communicate to an external device. In some embodiments, for example as shown in
The electronics module 2806 can be substantially cylindrical in shape. In some embodiments, an outer diameter of the electronics module 2806 is substantially equivalent to an outer diameter of the catheter 2804. The electronics module 2806 can have a lumen extending therethrough and sidewall openings in fluidic communication with the lumen such that fluids can be delivered or withdrawn through the electronics module 2806. In some embodiments, the electronics module 2806 is not configured for fluid delivery or withdrawal and does not have a lumen and/or sidewall openings, in which case the catheter 2804 would contain a side port for fluid communication between the catheter lumen and the surrounding bodily fluid.
In some embodiments, a system of the present technology can be configured to determine a physiological parameter of a patient based on data obtained by a vascular access device characterizing a parameter of the device. For example, because a catheter of an implanted vascular access device moves in a characteristic pattern throughout a patient's cardiac cycle, data characterizing motion of the catheter can be used to determine a heart rate parameter of the patient, a cardiac contractility parameter of the patient, a cardiac output parameter of the patient, or another parameter of the patient that is indicative of the patient's cardiac function.
The device 3000 can be configured to obtain data characterizing displacement and/or deformation of the elongated member 3004, which can be utilized to determine certain physiological parameters of a patient. The hub 3002 can carry one or more first sensing elements 3006 and the elongated member 3004 can carry one or more second sensing elements 3008. Although
To obtain data characterizing motion of the elongated member 3004, the first sensing element 3006 can comprise a proximity sensor configured detect a distance between the first sensing element 3006 and the second sensing element 3008. The first sensing element 3006 can comprise any suitable proximity sensing modality such as, but not limited to, photoelectric, inductive, capacitive, Hall effect, ultrasonic, etc. In some embodiments, the second sensing element 3008 can comprise an emitter configured to emit sensing energy and the first sensing element 3006 can comprise a detector configured to detect the sensing energy emitted by the emitter. In these and other embodiments, the sensing energy detected by the first sensing element 3006 can be used to determine a distance between the first and second sensing elements 3006, 3008. Additionally or alternatively, the second sensing element 3008 can comprise a passive target and the first sensing element 3006 can comprise a detector configured to detect the second sensing element 3008. For example, the first sensing element 3006 can comprise an inductive proximity sensor having an oscillation circuit and a coil configured to emit a magnetic field. The second sensing element 3008 can comprise a ferrous and/or conductive material that modifies the magnetic field in a distance-dependent manner. As the second sensing element 3008 moves closer to the first sensing element 3006, eddy currents are progressively generated in the second sensing element 3008, which in turn progressively create an opposing magnetic field that reduces the inductance of the inductive proximity sensor.
Still, in some embodiments, the second sensing element 3008 can comprise a proximity sensor configured to detect a distance between the second sensing element 3008 and the first sensing element 3006. As detailed above with respect to the first sensing element 3006, the second sensing element 3008 can comprise any suitable proximity sensing modality and the first sensing element 3006 can be an emitter or a passive target.
According to various embodiments, both the first sensing element 3006 and the second sensing element 3008 can comprise proximity sensors. The first and second sensing elements 3006, 3008 can be configured to detect one another and/or the first sensing element 3006 and/or the second sensing element 3008 can be configured to detect a target. For example, both the first and second sensing elements 3006, 3008 can comprise inductive proximity sensors configured to detect a passive target that is positioned on the vascular access device 3000, separate from the vascular access device 3000 but implanted within the patient, or external to the patient. The first and second sensing elements 3006, 3008 can comprise the same sensing modality or different sensing modalities. Additionally or alternatively, the first and second sensing elements 3006, 3008 can be configured to detect the same target or different targets.
In some embodiments, one or both of the first and second sensing element 3006, 3008 can comprise an emitter and/or a target configured to be detected by an extracorporeally-positioned detector. For example, the first and second sensing elements 3006, 3008 can comprise conductive material configured to be detected by an inductive proximity sensor positioned on the patient (e.g., on the patient's chest, on the patient's back, etc.) and the first and second sensing elements 3006, 3008 can comprise conductive material configured to be detected by the proximity sensor (e.g., by modifying the magnetic field generated by the proximity sensor as detailed herein). In these and other embodiments, displacement of the first and second sensing elements 3006, 3008, and thereby motion of the catheter, can be detected by the proximity sensor. The external proximity sensor can be secured to the patient (e.g., via medical tape, a bandage, etc.) to continuously obtain data characterizing motion of the catheter and/or the proximity sensor can be intermittently positioned
According to various aspects of the present technology, motion of a catheter can be characterized without determining a distance between the catheter and a hub of the vascular access device. For example,
In some embodiments, the catheter can comprise multiple sensing elements spaced around a circumference of the catheter and/or along a length of the catheter. For example,
The sensing element 3308 can be configured to obtain data characterizing a physiological parameter of the patient, a performance parameter of the device, a parameter of a treatment, or another parameter as described herein. Examples embodiments of the sensing element 3308 are detailed below. These examples are not intended to be exhaustive, but rather illustrate the various modalities, configurations, and functions of sensing elements of the present technology.
In some embodiments, the sensing element 3308 carried by the hub 3302 can be configured to obtain data characterizing a parameter of a needle configured to transport fluid in or out of the reservoir 3306 such as, but not limited to, data characterizing a presence of a needle within the reservoir 3306, data characterizing a position of a needle relative to a specific reference point on the hub 3302 (e.g., a distance between a distal tip of a needle and a septum covering the reservoir 3306 or a base of the reservoir 3306, etc.), data characterizing a material of the needle, etc. For example, the sensing element 3308 can comprise a pressure transducer positioned within the reservoir 3306 at the base portion 3302a of the hub 3302. The sensing element 3308 can be configured to obtain data characterizing a pressure within the reservoir 3306 such that, when a needle is inserted into the reservoir 3306 and contacts the sensing element 3308, a pressure detected by the sensing element 3308 increases. Additionally or alternatively, the sensing element 3308 can comprise a conductive element such that, when a conductive (e.g., metal) needle is inserted into the reservoir 3306 and contacts the sensing element 3308, an electrical circuit is opened or closed. In some embodiments, the sensing element 3308 can comprise an inductive proximity sensor configured to emit a magnetic field that is modified by a conductive object, such as a metallic needle, in a distance-dependent manner such that the sensing element 3308 is configured to measure a distance to the needle. A system of the present technology can use any of the previously-described data to determine whether the needle is properly inserted into the reservoir 3306 and whether it is safe to proceed with delivery or aspiration of fluid through the needle.
The sensing element 3308 can be configured to detect the presence of an object, such as a needle, within the reservoir 3306 and/or a position of an object within the reservoir 3306. It may be advantageous for the sensing element 3308 to determine a presence and/or position of an object, such as a needle, relative to the reservoir 3306 of the hub 3302 without contacting the object, for example so that the sensing element 3308 can be contained within the housing 3304 of the hub 3302 and is not exposed to fluids in the reservoir 3306. Accordingly, the sensing element 3308 can comprise a non-contact proximity sensor such as a photoelectric proximity sensor, a magnetic proximity sensor, an inductive proximity sensor, etc. Still, in some embodiments, the sensing element 3308 comprises an electromechanical sensor such as a linear variable differential transducer, a pressure transducer, a switch, etc. A sensing element 3308 comprising a pressure transducer can comprise a pressure-sensitive film, a force sensitive resistor, a strain gauge, a solid state transducer, a wet pressure sensor, or any other suitable pressure transducer.
In some embodiments, the sensing element 3308 can be configured to obtain data characterizing an indicator carried by the needle that is configured to communicate information regarding a patient or a treatment. For example, the sensing element 3308 can be configured to read machine-readable indicia such as a label, barcode, Quick Read (QR) code, iQR code, micro QR code, FrameQR code, or other machine-readable indicia carried by the needle. Such indicia can contain information regarding an identity of the patient, a type of the needle, injection system including needle and catheter system appropriate for power injection, a type of fluid to be transported through the needle, a location of treatment, a date of treatment, a time of treatment, or other patient information, device information, or treatment information. The sensing element 3308 can be configured to transmit data characterizing the information to a computing device for storage, interpretation by the computing device, etc.
The sensing element 3308 carried by the hub 3302 can be configured to obtain data characterizing one or more parameters such as, but not limited to, pressure within the reservoir 3306, flow rate within the reservoir 3306, temperature within the reservoir 3306, temperature of the hub 3302, temperature of the patient's tissues surrounding the hub 3302, presence and/or position of an object in the reservoir 3306, constituents and/or properties of fluid within the reservoir 3306, others, or combinations thereof.
In some embodiments, it may be advantageous for a hub of a vascular access device to comprise a first portion defining the reservoir and a second portion carrying electronic components, and for the first and second portions to be physically separable. For example, if a patient completes intravascular therapy but a clinician wishes to continue remote monitoring of the patient's health, it may be desirable to remove the catheter and reservoir from the patient while leaving the portion of the device containing the electronics implanted in the patient. A clinician and/or patient may want to remove the catheter and reservoir due to risks of complications occurring from long-term indwelling and/or the hassle of maintenance (e.g., monthly flushes and heparin locks, etc.). Moreover, the ability to remove the catheter and/or reservoir from the patient enhances the safety of the device, as either component can be removed if infection, thrombosis, or another illness were to occur while the device was implanted. Additionally or alternatively, it may be desirable to remove the electronics from the patient while leaving the catheter and reservoir implanted.
According to several embodiments of the present technology, a vascular access device (or component thereof) can be configured to measure radiation exposure. For example, any of the vascular access devices disclosed herein can include a sensing element configured to detect and/or measure radiation. The sensing element can provide a continuous measurement of cumulative dose and current dose rate, and can warn the patient or healthcare team with an audible alarm when a specified dose rate or a cumulative dose is exceeded. In some embodiments, the sensing element only measures radiation intermittently, or on demand. The sensing element can be carried on and/or in the hub, or may be a separate component communicatively coupled to the hub and/or another component of the system. In some embodiments, for example, the vascular access device includes an integrated dosimeter. The integrated dosimeter can be an ion chamber dosimeter, or may be a thermoluminescent diode (TLD) dosimeter. The TLD can be configured to measure ionizing radiation exposure by measuring the intensity of light emitted from a Dy or B doped crystal in the detector when heated. The intensity of light emitted is dependent upon the radiation exposure.
Many physiologic events create characteristic sounds in the patient's body that can provide insight into the patient's health. Listening to the internal sounds of the body (or “auscultation”) is often a fundamental part of clinical examination and diagnostic procedures. Typically, auscultation is performed by a highly trained medical professional using a stethoscope. To examine a patient's lungs and respiratory function, for example, a medical professional may listen to sounds transmitted from the patient's body via the stethoscope, differentiate multiple body sounds from one another (e.g., tracheal sounds from bronchial sounds from bronchovesicular sounds from vesicular sounds, breath sounds from cardiac sounds, etc.), mentally evaluate various parameters of a sound of interest (e.g., frequency, intensity, duration, number, etc.), and mentally compare the sound of interest to known corresponding sounds (e.g., normal breath sounds, crackling sounds characteristic of chronic obstructive pulmonary disorder, wheezing sounds characteristic of pneumonia, absence of sound characteristic of pneumothorax, etc.). The ability to discern and interpret the body's many diverse sounds in a clinically meaningful way takes years of practice and is difficult to master. Not surprisingly, deficiencies in auscultation skills have been widely reported in the medical literature.
Despite the challenges associated with training, auscultation remains an important tool for obtaining information regarding physiological events, pathological changes, specific medical conditions, and overall health of a patient. Accordingly, various embodiments of the present technology are directed towards devices and systems configured to obtain audio data from the patient's body and process the audio data to obtain information regarding a patient's health. Additionally or alternatively, a medical device and/or system of the present technology can be configured to obtain audio data to obtain information regarding a performance or operation of the device and/or a treatment of the patient with the device.
The medical device 3600 can be configured to be positioned intradermally, subcutaneously, within a body lumen (e.g., a blood vessel, a bile duct, an intestine, etc.), secured to a wall of an organ, or in any other suitable location. In some embodiments, the medical device 3600 can be configured to be positioned on an external surface of a patient's skin. The medical device 3600 can provide one or more therapeutic functions such as drug delivery, electrical stimulation, structural support, and others. In some embodiments, the medical device 3600 has one or more additional diagnostic functions, such as temperature monitoring, blood constituent monitoring, etc. As described in greater detail below, the medical device 3600 can be a vascular access device, such as any of the vascular access devices disclosed herein.
The audio data obtained by the sensing element 3602 can be used by the controller and/or a medical professional to identify a physiological event such as, but not limited to, contraction of a patient's heart, opening or closing of patient's heart valve, blood flow through a patient's cardiovascular system, inhalation of air into a patient's lung, exhalation of air from a patient's lungs, sneezing, wheezing, coughing, snoring, speaking, peristalsis, muscular contraction, or other physiological events. Additionally or alternatively, the audio data obtained by the sensing element 3602 can be used by the controller and/or a medical professional to determine and/or indicate one or more physiological parameters of the patient. For example, the data can be used to determine a heart rate parameter, a heart rhythm parameter, a respiratory rate parameter, a cardiac output parameter, a forced expiratory volume in one second parameter, a forced vital capacity parameter, a forced expiratory flow parameter, a tidal volume parameter, a forced inspiratory flow parameter, a peak expiratory flow parameter, or another parameter of a patient. Additionally or alternatively, the data and/or derived parameters can be used by a system of the present technology and/or a medical professional to determine the presence and/or extent of a medical condition that the patient is afflicted by. Such medical conditions can include, but are not limited to, pneumothorax, valve disease, arrhythmia, pericarditis, acute myocardial infarction, septal defects, endocarditis, congestive heart failure, chronic obstructive pulmonary disorder, pulmonary edema, pneumonia, interstitial lung disease (e.g., pulmonary fibrosis, late-stage COPD, etc.), atelectasis, vomiting, cough, orthopnea, pulmonary embolism, sleep apnea, pleural effusion, emphysema, epiglottitis, recurrent laryngeal nerve paralysis, glottic larynx cancer, stroke, brain tumors, and/or falls.
As shown in
In some embodiments, the sensing element(s) 3714 can be carried by the device 3700 at specific locations based, at least in part, on an intended purpose of the sensing element(s) 3714. For example, it may be advantageous for a sensing element 3714 configured to detect cardiac sounds to be carried by the distal end portion 3704b of the catheter 3704 so that, when the device 3700 is implanted, the sensing element 3714 is located near or within the heart. In another example, it may be advantageous to position a sensing element 3714 configured to detect respiratory sounds at the hub 3702 so that, when the device 3700 is implanted, the sensing element 3714 is located proximate the lungs and/or airways. Positioning a sensing element 3714 near the source of an acoustic wave to be detected can greatly improve the signal to noise ratio. Additionally or alternatively, a position and/or orientation of the sensing element(s) with respect to the device 3700 and/or the patient can be based, at least in part, on a directionality (e.g., a polar pattern) of the sensing element(s) 3714. For example, if the sensing element 3714 carried by the hub 3702 comprises a microphone having a cardioid polar pattern, the sensing element 3714 will only detect acoustic waves from one direction and should be positioned relative to the hub 3702 such that, when the device 3700 is implanted, the sensing element 3714 is oriented towards a source of an acoustic wave of interest (e.g., the heart to detect cardiac sounds, the lungs to detect respiratory sounds, etc.).
According to several embodiments, the controller 3716 can be configured to estimate a cardiac output parameter based at least in part on audio data acquired by the device 3700. The cardiac output parameter can be an estimate of cardiac output, a change in cardiac output, a characterization of output state (e.g., a high output, a low output states, etc.), or another suitable cardiac output parameter. In a person with a healthy heart and/or heart valves, blood flow out of the left ventricle and across the aortic valve is not audible through a stethoscope. When the blood flow increases, an audible murmur often arises because of the flow becoming turbulent. The murmur may get louder as the flow increases, which is sometimes referred to as a flow murmur or high output murmur. In some embodiments, the sensing element 3714 can be configured to obtain audio data characterizing blood flow over the aortic valve, and the controller 3716 can be configured to use the acquired audio data to characterize the flow (e.g., low flow versus high flow, etc.). This characterization can be used to determine if cardiac output is increasing or decreasing, and such a determination could be in many clinical scenarios. For example, if a patient has a fever and the controller 3716 indicates that the patient is experiencing an increase in blood flow based on audio data collected by the sensing element 3714, this can indicate that the patient is showing early signs of sepsis.
The controller 3716 can, in some embodiments, be configured to estimate a source of a murmur based at least in part on audio data acquired by the device 3700. A murmur can be indicative of valvular disease such as stenosis or insufficiency, which can occur at any of the four heart valves. To estimate the source of the murmur, the controller 3716 can use audio data to indicate whether the murmur occurs during systole or diastole and/or the portion of systole or diastole that the murmur occurs during (e.g., mid systole, holosystole, end systole, etc.), which can indicate the source of the murmur. In some embodiments, the controller 3716 can be configured to quantitatively characterize a parameter of the audio data (e.g., pitch, frequency, amplitude, intensity, etc.), which can indicate the source of the murmur. Additionally or alternatively, the controller 3716 can be configured to qualitatively characterize the sound. For example, the controller 3716 can characterize the sound as a “click,” which can be indicative of mitral valve prolapse. In some cases, a murmur can occur due to an atrial or ventricular septal defect. Accordingly, the controller 3716 can be configured to use the audio data to detect a murmur that is characteristic of an atrial septal defect and/or a ventricular septal defect, which can be used to indicate the source of the murmur.
In some embodiments, based on the audio data (alone or in combination with one or more other sensed parameters), the controller 3716 can be configured to detect a murmur from valvular dysfunction secondary to vegetation formation that is indicative of endocarditis. Additionally or alternatively, the controller 3716 can be configured to detect a characteristic sound of cardiac rub that is indicative of pericarditis.
The controller 3716 can be configured to characterize an abnormal heart sound and/or a change in a heart sound of a patient, which can indicate one or more cardiovascular conditions. According to various embodiments, the controller 3716 can be configured to detect an abnormal heartbeat of a patient. For example, the controller 3716 can be configured to characterize an abnormal cardiac sound and/or a change in a cardiac sound of a patient, which can indicate an abnormal heartbeat associated with bradycardia, tachycardia, premature atrial contractions, atrial fibrillation, atrial flutter, paroxysmal supraventricular tachycardia, accessory pathway tachycardia, AV nodal reentrant tachycardia, premature ventricular contractions, ventricular tachycardia, ventricular fibrillation, long QT syndrome, bradyarrhythmia, sinus node dysfunction, heart block, or another arrythmia.
In some embodiments, based on the audio data (alone or in combination with one or more other sensed parameters), the controller 3716 can be configured to characterize an abnormal cardiac sound and/or a change in a cardiac sound of a patient that is indicative of acute myocardial infarction.
Typical heart sounds of a healthy patient comprise a first heart sound (S1) corresponding to closing of the mitral and tricuspid valves and a second heart sound (S2) corresponding to closing of the aortic and pulmonic valves. Patients with heart failure often have a third heart sound (S3) and/or a fourth heart sound (S4), which are abnormal. Based on the audio data, the controller 3716 can be configured to determine the presence of abnormal heart sounds, which can indicate signs of heart failure.
In some cases, a patient's heart function and health can be estimated by evaluating non-cardiac sounds. For example, a patient with venous congestion will often develop pulmonary edema, which can cause crackles or “rales” in the lungs, wheezing, and/or changes in respiratory rate. Patients with congenital heart failure often experience orthopnea, or positional shortness of breath associated with an increase in pulmonary edema when the patient lies flat. Such increase in pulmonary edema can cause and/or exacerbate the abnormal breath sounds associated with pulmonary edema. As such, the controller 3716 can be configured to detect and/or characterize respiratory sounds and/or other body sounds that can be used to estimate a patient's cardiac function. The controller 3716 can be configured to use the audio data alone or in combination with another sensed parameter. For example, a position of a patient can be detected by an accelerometer and/or gyroscope which, when used by the controller 3716 in combination with audio data characterizing abnormal breath sounds characteristic of pulmonary edema, can be used to detect orthopnea.
Many pathologies and medical conditions can cause changes in a patient's breath sounds and/or abnormal breath sounds. The controller 3716, according to various embodiments of the present technology, can be configured to use the audio data (alone or in combination with one or more other sensed parameters) to detect such changes and/or abnormalities in a patient's breath sounds. For example, as noted above, the controller 3716 can be configured to detect crackles, rales, or wheezing in a patient's breath sounds, which can be indicative of pulmonary edema.
According to some embodiments, the controller 3716 can be configured to estimate pulmonary function testing parameters, such as forced expiratory volume during the first (FEV1), second (FEV2), and third (FEV3) seconds of a forced breath and/or forced vital capacity (FVC). FEV1 and FVC are often diminished in patients with obstructive lung disease like asthma and chronic obstructive pulmonary disease (e.g., emphysema, chronic bronchitis, etc.). When obstructive lung disease worsens, the expiratory phase of breathing is prolonged and the sound of wheezing increases. Based on the patient's baseline pulmonary function and obtained audio data, the controller 3716 can determine a time of the patient's expiratory phase and/or characterize the presence and extent of wheezing (e.g., by volume, pitch, etc.), which can be used to estimate changes in underlying lung function.
According to various embodiments, the controller 3716 can be configured to detect the presence and/or extent of a pneumothorax in a patient. A patient suffering from a pneumothorax will have an absence in breath sounds in the area of the pneumothorax. Thus, the controller 3716 can be configured to determine that there is an absence of an expected breath sound, which can indicate the presence of a pneumothorax. In some embodiments, the controller 3716 can be configured to characterize a degree of a loss of breath sounds, which can be used to estimate a size of the pneumothorax. In some embodiments, based on the audio data (alone or in combination with one or more other sensed parameters), the controller 3716 is configured to detect diminished or absent breath sounds in a region of atelectasis (obstructive or non-obstructive), diminished breath sounds in a region of a pleural effusion, and/or diminished breath sounds due to empyema.
Lobar pneumonia can lead to consolidation of one or more lobes of the lung, which will often cause a loss of breath sounds or “bronchiolar” breath sounds in which air passes through the large and medium airways, but not all the way to the alveoli. According to various embodiments of the present technology, the controller 3716 can be configured to detect a loss of breath sounds and/or bronchiolar breath sounds, which can be used to determine if a patient is suffering from lobar pneumonia and/or lobar consolidation. Lobar consolidation can also lead to egophony. Traditionally, egophony is detected when a medical professional performing auscultation asking a patient to say a long “e” sound and instead they produce an “a” sound. The controller 3716 can be configured to use audio data collected during such an exercise to detect such an abnormality in the patient's speech, which can be indicative of lobar pneumonia and/or consolidation.
The controller 3716 can, according to various embodiments, use the audio data either alone or in combination with one or more other sensed parameters to detect a pulmonary embolism. For example, a pulmonary embolism can cause strain on the right side of the heart, which can cause a right heart fourth heart sound (S4). In some cases, a pulmonary embolism can cause pulmonary edema which, as detailed above, can cause changes in respiratory rate and/or characteristic sounds such as crackles, rales, and/or wheezing.
In some embodiments, based on the audio data (alone or in combination with one or more other sensed parameters), the controller 3716 is configured to detect coarse or dry breath sounds, which can be used to detect interstitial lung disease (e.g., pulmonary fibrosis, late-stage chronic obstructive pulmonary disorder, etc.). As described above with reference to
Anaphylaxis can cause stridor and/or wheezing upon inspiration as a result of upper airway and/or laryngeal edema due to anaphylaxis. Additionally or alternatively, a patient's cardiac output can increase due to anaphylaxis. Accordingly, a controller 3716 according to various aspects of the present technology can be configured to use the audio data to detect stridor, wheezing, and/or cardiac output, which can be used to detect anaphylaxis.
In some embodiments, based on the audio data (alone or in combination with one or more other sensed parameters), the controller 3716 is configured to detect the sound of snoring intermixed with absence of breath sounds while a patient is lying down (for example, as measured by an activity and/or position sensing element) which can be used to detect sleep apnea.
In some embodiments, based on the audio data (alone or in combination with one or more other sensed parameters), the controller 3716 is configured to detect slurred speech, which can be used to detect a stroke or a brain tumor.
The controller 3716 can be configured to detect cough based on the audio data (alone or in combination with one or more other sensed parameters). In some embodiments, the controller 3716 is configured to determine a parameter of a cough (e.g., a frequency, an intensity, dry, productive, etc.) from the audio data.
In some embodiments, based on the audio data (alone or in combination with one or more other sensed parameters), the controller 3716 is configured to detect abnormal vocal and/or gastrointestinal sounds, which can be used to detect vomiting. Additionally or alternatively, the controller 3716 can be configured to detect mastication based on the acquired audio data (e.g., based on vocal sounds, gastrointestinal sounds, etc.). In some embodiments, the controller 3716 can create and index the audio data to characterize mastication. For example, the controller 3716 can detect a time of mastication, which can be indicative of decreased appetite, hypogeusia, anorexia, etc.
The controller 3716 can, according to various embodiments, be configured to detect swallowing. For example, the controller 3716 can use the audio data, alone or in combination with one or more other sensed parameters, to detect vocal and/or gastrointestinal sounds of a patient to detect swallowing. Swallowing detection can be for monitoring a patient's consumption of food or liquids, a patient's nutritional status, a patient's compliance to a feeding or fluid regimen, etc. In some embodiments, the device 3700 can be configured to provide a notification (e.g., a tactile notification, a visible notification, an audible notification, etc.) to the patient based on the detected swallowing. For example, the device 3700 can provide a notification the patient to communicate that the patient should consume fluids. Such notification can be provided, for example, if the controller 3716 does not detect a swallow over a predetermined duration of time and/or if the controller 3716 detects tachycardia, which could be caused by dehydration. In some embodiments, the device 3700 can be configured to provide a notification to the patient to provide feedback regarding the patient's compliance to a treatment plan, a requested action, etc.
Various pathologies and medical conditions can cause changes in a patient's voice. For example, epiglottitis can cause stridor and/or “hot potato voice,” glottic larynx cancer can cause a hoarse voice, and recurrent laryngeal nerve paralysis, which can occur with mediastinal masses, can cause vocal changes. The controller 3716 can be configured to use the audio data to detect vocal changes or abnormalities, which can indicate one or more pathologies or medical conditions.
In some embodiments, the controller 3716 can be configured to use the audio data (alone or in combination with one or more other sensed parameters) to detect extrathoracic sounds. For example, the controller 3716 can be configured to detect abdominal and/or gastrointestinal sounds (or the lack thereof), such as hypoactive bowel sounds, hyperactive bowel sounds, borborygmi, flatulence, etc. Abnormal abdominal and/or gastrointestinal sounds can be indicative of obstruction, ileus, hernia, tumor, ulcers, bleeding, inflammatory bowel disease, Crohn's disease, infection, food allergies, peritonitis, etc. Additionally or alternatively, the controller 3716 can be configured to detect womb sounds of a pregnant woman during gestation, which can provide insight into the health of the woman and/or her child.
The controller 3716 can be configured to use the audio data (alone or in combination with one or more other sensed parameters) to detect a sound originating from outside of the patient's body. For example, the controller 3716 can be configured to detect sounds associated with scratching of the patient's skin, which can indicate a response to a medical treatment, an allergy, a dermatological disorder, a psychological disorder, etc. As a specific example, the controller 3716 can be configured to detect scratching of the skin secondary to pruritis, which can be a side effect of chemotherapy or hyperbilirubinemia.
In some embodiments, the controller 3716 can use the audio data (alone or in combination with one or more other sensed parameters) to detect an activity of a patient. For example, the controller 3716 can detect a sound associated with a patient falling, such as the sound of airflow, calls for help, or cries of pain. In some embodiments, the controller 3716 can use data from an accelerometer to facilitate the detection of an activity of the patient in combination with the audio data.
In some embodiments, the controller 3716 can be configured to use the audio data (alone or in combination with one or more other sensed parameters) to detect a parameter associated with a performance of the device 3700. For example, the controller 3716 can detect a parameter of the audio data (e.g., a presence of the data, an amplitude, an intensity, a frequency, a pitch, etc.) and indicate whether the device 3700 is performing as intended. In some embodiments, the controller 3716 can detect a change in the audio data over time, which can be indicative of a change in the impedance of the sensing element 3714.
The catheter 3800 can further include an annular electrode 3808 extending around a transverse perimeter of the catheter body 3802, a first sensing element 3810 within the first axial lumen 3804, and a second sensing element 3812 within the second axial lumen 3806. The catheter body 3802 can define a window 3814 opening into the first axial lumen 3804 and proximate to the first sensing element 3810. The catheter 3800 can further include electrical leads 3816a-3816c embedded in the internal wall 3807 or another wall portion of the catheter body 3802 and extending proximally from the annular electrode 3808, the second sensing element 3812, and the first sensing element 3810, respectively. In other embodiments, the first sensing element 3810, the second sensing element 3812, and the window 3814 can have different arrangements. For example, the window 3814 can open into the second axial lumen 3806 and/or be proximate to the second sensing element 3812. As another example, the second sensing element 3812 can be embedded in the internal wall 3807 or another wall portion of the catheter body 3802 rather than being within the second axial lumen 3806.
With reference again to
Although many of the embodiments are described above with respect to vascular access devices, the technology is applicable to other applications and/or other approaches, such as other types of implantable medical devices (e.g., pacemakers, implantable cardioverter/defibrillators (ICD), deep brain stimulators, insulin pumps, infusion ports, orthopedic devices, and monitoring devices such as pulmonary artery pressure monitors). Moreover, other embodiments in addition to those described herein are within the scope of the technology. Additionally, several other embodiments of the technology can have different configurations, components, or procedures than those described herein. A person of ordinary skill in the art, therefore, will accordingly understand that the technology can have other embodiments with additional elements, or the technology can have other embodiments without several of the features shown and described above with reference to
The descriptions of embodiments of the technology are not intended to be exhaustive or to limit the technology to the precise form disclosed above. Where the context permits, singular or plural terms may also include the plural or singular term, respectively. Although specific embodiments of, and examples for, the technology are described above for illustrative purposes, various equivalent modifications are possible within the scope of the technology, as those skilled in the relevant art will recognize. For example, while steps are presented in a given order, alternative embodiments may perform steps in a different order. The various embodiments described herein may also be combined to provide further embodiments.
As used herein, the terms “generally,” “substantially,” “about,” and similar terms are used as terms of approximation and not as terms of degree, and are intended to account for the inherent variations in measured or calculated values that would be recognized by those of ordinary skill in the art.
Moreover, unless the word “or” is expressly limited to mean only a single item exclusive from the other items in reference to a list of two or more items, then the use of “or” in such a list is to be interpreted as including (a) any single item in the list, (b) all of the items in the list, or (c) any combination of the items in the list. Additionally, the term “comprising” is used throughout to mean including at least the recited feature(s) such that any greater number of the same feature and/or additional types of other features are not precluded. It will also be appreciated that specific embodiments have been described herein for purposes of illustration, but that various modifications may be made without deviating from the technology. Further, while advantages associated with certain embodiments of the technology have been described in the context of those embodiments, other embodiments may also exhibit such advantages, and not all embodiments need necessarily exhibit such advantages to fall within the scope of the technology. Accordingly, the disclosure and associated technology can encompass other embodiments not expressly shown or described herein.
For the purposes of this specification and appended claims, unless otherwise indicated, all numerical values used in the specification and claims, are to be understood as being modified in all instances by the term “about.” Accordingly, unless indicated to the contrary, the numerical parameters set forth in the following specification and attached claims are approximations that may vary depending upon the desired properties sought to be obtained by the present invention. At the very least, and not as an attempt to limit the application of the doctrine of equivalents to the scope of the claims, each numerical parameter should at least be construed in light of the number of reported significant digits and by applying ordinary rounding techniques.
Notwithstanding that the numerical ranges and parameters setting forth the broad scope of the invention are approximations, the numerical values set forth in the specific examples are reported as precisely as possible. Any numerical value, however, inherently contains certain errors necessarily resulting from the standard deviation found in their respective testing measurements. Moreover, all ranges disclosed herein are to be understood to encompass any and all subranges subsumed therein. For example, a range of “1 to 10” includes any and all subranges between (and including) the minimum value of 1 and the maximum value of 10, that is, any and all subranges having a minimum value of equal to or greater than 1 and a maximum value of equal to or less than 10, e.g., 5.5 to 10.
This application claims the benefit of the following prior applications: U.S. Provisional Application No. 63/261,454, filed Sep. 21, 2021, andU.S. Provisional Application No. 63/262,989, filed Oct. 25, 2021.
| Filing Document | Filing Date | Country | Kind |
|---|---|---|---|
| PCT/US22/76731 | 9/20/2022 | WO |
| Number | Date | Country | |
|---|---|---|---|
| 63261454 | Sep 2021 | US | |
| 63262989 | Oct 2021 | US |
