Stent monitoring assembly and method of use thereof

Abstract

The present invention provides an assembly including a stent and sensors positioned on and / or inside the stent. [Solution] In the assembly of the present invention, within the scope of a certain particular aspect, the sensor is a wireless sensor, which includes, for example, one or more fluid pressure sensors, contact sensors, position sensors, accelerometers, pulse pressure sensors, blood volume sensors, blood flow sensors, blood chemistry sensors, blood metabolism sensors, mechanical stress sensors and / or temperature sensors. Within the scope of a certain particular aspect, these stents can be used to assist in stent placement, monitor stent function, differentiate complications of stent treatment, monitor physiological parameters and / or to medically image internal passages, such as vascular lumens.

Description

Technical Field

[0001] The present invention generally relates to the field of vascular and non-vascular stents, and more particularly to stents used in monitoring various medical conditions including, for example, the occurrence of restenosis, stent occlusion, and / or other diseases.

[0002]

Description of Related Applications

Background Art

[0003] A stent is generally a cylindrical, flexible, and hollow scaffold-like medical device that can be inserted into a body lumen to physically maintain the patency of structures and / or passages (typically tubular organ structures, e.g., blood vessels, gastrointestinal tract, urinary tract, airway, or male and female reproductive tracts) that have become closed or partially occluded, thereby reducing or blocking the passage of material. Stents are usually placed in a compressed form into the affected organ by percutaneous insertion (e.g., vascular stents) or through a congenital opening (e.g., mouth, nose, or anus), and are then expanded into position (often by inflating a balloon or by using a "self-expanding" stent) thereby opening the organ lumen and returning it to its original size and shape. Stents can be used to treat and / or prevent a wide variety of diseases and / or conditions resulting from luminal stenosis or obstruction, whether caused by trauma to the vascular wall or external compression (benign or malignant tumors, abscesses, cysts), disease processes occurring within the vascular wall (e.g., cancer, atherosclerosis, inflammation, scarring, or stenosis), or / or disease processes occurring on the surface of the vascular wall (or within the lumen) (thrombosis, atherosclerosis, restenosis, tumor growth, inflammation and scarring, gallstones, urinary stones, mucosal impaction, etc.). Stents are used in a wide variety of tubular internal passages to maintain the normal passage of intraluminal substances (blood, digestive contents, digestive enzymes and bile, air, urine, reproductive substances), such passages include, for example, vascular structures (e.g., coronary arteries, carotid arteries, cerebral arteries, vertebral arteries, iliac arteries, femoral arteries, popliteal arteries, tibial arteries, mesenteric arteries, pulmonary arteries, and other branches of these arteries), large veins (e.g., superior vena cava, inferior vena cava, veins of the neck, upper and lower extremities), and digestive tract structures. Examples include (e.g., esophagus, duodenum, small intestine, colon, biliary tract and pancreatic duct), lung structures (e.g., for maintaining the patency of the trachea, bronchi, bronchioles or alveoli), urinary system structures (urinary collection system, ureters, urethra), female and male reproductive system structures (e.g., for maintaining the patency of the Fallopian duct, urethra, and prostatic portion), cranial and intracranial sinus structures (maxillary sinus, frontal sinus, lacrimal duct), and inner ear structures (middle ear ventilation tubes), and inner ear structures (middle ear ventilation tubes).

[0004] Typically, stents are composed of metal components (such as stainless steel, titanium, platinum, nitinol, and cobalt-chromium) and / or polymer components (degradable and non-degradable polymers), and these stents are often configured to have a single, integrated structure or to consist of multiple components (e.g., a bifurcated stent system). Stents may be non-degradable, partially degradable, or completely degradable. In addition, stents may be coated with one or more different compositions, such as both polymers and chemicals (see, for example, U.S. Patent Nos. 8,003,157, 7,294,145, 8,277,867, 8,277,833, and U.S. Patent Publication No. 2005 / 0181011 and U.S. Patent No. 5,716,981). Typical examples of stents include those disclosed in U.S. Patent Nos. 6,852,153, 7,942,923, 7,753,947, 7,879,082, and 8,287,588.

[0005] One of the primary uses of stents is the treatment of coronary artery disease, peripheral vascular disease, and cerebrovascular disease. Simply put, coronary artery disease typically begins with the development of stenosis or occlusion within the coronary vascular system (right coronary artery, left coronary artery, left anterior descending artery, left circumflex artery, coronary sinus, and their branches); peripheral vascular disease is most often caused by stenosis or occlusion of the arteries of the legs (common iliac artery, iliac artery, femoral artery, superficial femoral artery, popliteal artery, and their branches), the renal arteries (renal arteries), or the arteries of the upper limbs; and cerebrovascular disease involves the arteries of the head and neck (common carotid artery, internal carotid artery, and their branches, cerebral artery, vertebral artery), but any blood vessel in the body may also be affected. Partial occlusion of one or more coronary arteries is often due to the development and progression of atherosclerotic plaque formation, resulting in angina (chest pain and shortness of breath on exertion), while complete occlusion of coronary arteries is usually due to plaque rupture and thrombus formation, resulting in acute coronary syndrome (ACS) and / or myocardial infarction (heart attack). In peripheral artery disease, partial occlusion of blood vessels in the legs results in claudication (pain or "heaviness" on walking or exertion), while complete occlusion results in acute ischemia and gangrene. In cerebrovascular disease, narrowing of blood vessels supplying the brain results in syncope (fainting), dizziness and transient numbness (paralysis), weakness and speech disturbances (this is just a list of some of the symptoms), while complete occlusion results in cerebral vascular incidentalities (CVA or "attacks") and permanent neurological defects. To address problems caused by either stenosis or occlusion, stents are typically delivered to the occlusion site using a delivery device designed to send them out and deploy them across the lesion, thereby restoring blood flow downstream.The general method for deploying a stent is as follows: a catheter is inserted into the bloodstream (often via the femoral artery in the inguinal region), advanced through the bloodstream until the catheter reaches the site of stenosis or occlusion, then advanced across the lesion, and then the lesion is opened using only a balloon (angioplasty) or a stent crimped onto an expandable balloon catheter (direct stent placement). After the stent is deployed and the artery is opened, the expanded stent is left in place to maintain patency of the lumen of the previously occluded vessel. In the case of "self-expanding" stents, the balloon does not need to open the stent, and unlike these, the stent expands in place from the delivery catheter after deployment. Examples of such procedures are described in U.S. Patent No. 5,749,824 and International Publication No. 98 / 36709. Non-vascular stent placement follows almost the same procedure, but the stent is approached through a congenital opening (mouth, nose, or anus), and is usually positioned in place under direct visualization (endoscopic examination), and then expanded to complete the procedure.

[0006] In recent years, there have been many technological advancements in stent construction, drug loading, and delivery, but many shortcomings still remain that need to be addressed.

[0007] The precise placement, deployment, and adequate dilation of stents remain challenges, particularly in the vascular system, where indirect visualization techniques, such as angiography, are primarily used for stent placement. Angiography (in which radiopaque dyes flow through the bloodstream) only reveals the anatomical structure of the vascular lumen and does not provide information about abnormalities in the vessel wall (which are often segments with significant disease during treatment). Adequate and complete deployment (sufficient dilation) of stents is often difficult to confirm with angiography alone. Long and branched lesions (diseases occurring at artery bifurcations) often require the use of multiple stents, overlapping stents, or bifurcated stents, and accurate placement and precise determination of the amount of overlap between adjacent stents (high overlap between continuous or interconnected stents increases the risk of eventual failure) are also difficult to confirm. A stent equipped with sensors that can provide physicians with real-time information regarding vascular wall abnormalities, balloon and vascular wall pressure, stent location within the vascular wall, sufficient stent expansion and deployment, stent patency / lumen size, contact and overlap between adjacent / mutually connected stents, blood flow through the device, and confirmation of the stent's placement after deployment is extremely beneficial to the attending physician and significantly reduces the long-term incidence of complications.

[0008] Monitoring for potential complications after deployment (twisting, stent rupture, restenosis, thrombosis, incomplete closure) helps in managing patients well postoperatively and warns both patients and physicians of the potential for serious side effects. Monitoring the surface properties of the stent to determine the healing status of the device within the artery can help determine when and why the patient can be discontinued from antiplatelet (or anticoagulant) therapy. Continuous monitoring of physiological parameters, such as pulse rate, pulse pressure, blood pressure, and blood flow, can provide useful information about overall systemic and local cardiovascular function. Furthermore, in the case of biodegradable and bioerosive stents, sensors implanted on various surfaces within the polymer (typically polymer) stent (lumen and paralumen surfaces) and at various depths within the polymer (typically polymer) stent can provide useful information about the stent's dissolution rate and ultimate complete bioresorption. In drug-eluting stents, sensors can be used to monitor the release of therapeutic agents from the device.

[0009] Postoperative in-hospital monitoring of patients who have undergone stent placement is conducted through personal visits by hospital staff and the medical team, including medical monitoring (vital signs, telemetry, etc.) and, as needed, diagnostic imaging studies and blood studies. Once the patient is discharged, stent performance and patient prognosis are checked during regular visits to the physician's clinic. During these visits, the full medical history, physical examination, and complementary imaging and diagnostic studies are used to monitor the patient's progress and identify any potential complications. During these visits, the physician typically assesses physical signs and symptoms, performs appropriate studies (ECG, echocardiography, angiography), and questions the patient to determine their activity level, daily functional performance, pain, and rehabilitation progress. [Prior art documents] [Patent Documents]

[0010] [Patent Document 1] U.S. Patent No. 8,003,157 [Patent Document 2] U.S. Patent No. 7,294,145 [Patent Document 3] U.S. Patent No. 8,277,867 [Patent Document 4] U.S. Patent No. 8,277,833 [Patent Document 5] U.S. Patent Application Publication No. 2005 / 0181011 [Patent Document 6] U.S. Patent No. 5,716,981 [Patent Document 7] U.S. Patent No. 6,852,153 [Patent Document 8] U.S. Patent No. 7,942,923 [Patent Document 9] U.S. Patent No. 7,753,947 [Patent Document 10] U.S. Patent No. 7,879,082 [Patent Document 11] U.S. Patent No. 8,287,588 [Patent Document 12] U.S. Patent No. 5,749,824 [Patent Document 13] International Publication No. 98 / 36709 pamphlet [Overview of the Initiative] [Problems that the invention aims to solve]

[0011] Unfortunately, the majority of a patient's recovery period occurs between hospital or clinic visits. Therefore, accurately measuring and following the progression or worsening of symptoms, and correlating stent performance in "real life" with patient activity levels, exercise tolerance, rehabilitation programs, and medications, is extremely difficult. For much of this information, physicians rely on patient self-reporting to gain insights into postoperative treatment effectiveness and the course of recovery and rehabilitation. This is often further complicated by the fact that patients may not be entirely clear on what they should be seeking, lack knowledge of what constitutes "normal / expected" postoperative recovery, be non-compliant, or be unable to effectively communicate these symptoms. Furthermore, differentiating and tracking complications (in-hospital and in-hospital) before they become symptomatic and occur between physician visits, or differentiating and tracking complications that are difficult (or impossible) to detect, would also provide valuable and additional information for the management of stent patients. Currently, neither physicians nor patients have access to a type of "real-time," continuous, objective stent performance measurement that these individuals might otherwise have. The ability to monitor stent function in situ provides physicians with useful objective information during clinic visits. Furthermore, patients can obtain additional readings at home at various points in time (e.g., when experiencing pain, during exercise, after taking medication) to provide physicians with important complementary clinical information (which can be sent electronically to healthcare providers, even remotely), and can be given early warning indicators to request assistance or provide reassurance.

[0012] This invention provides novel stents that solve many of the problems of conventional stents, methods for constructing and using these novel stents, and further brings other related advantages.

[0013] In short, the provided assembly includes a stent and sensors for monitoring, in particular, the anatomical structure (and general health of the tissue) of the tissue surrounding the stent, the integrity or effectiveness of the stent, the full opening and precise deployment of the stent, the relationship between the stent and other stents or stent segments, the disease process, the movement of fluids through the stent, the healing of the stent in the body, stent rupture or impending rupture due to disease or other processes (e.g., restenosis, inflammation, benign or malignant tumor growth, clot formation), trauma, or interventional procedures (e.g., surgery). Typical stents suitable for use in the present invention include, for example, stents for blood vessels (e.g., coronary arteries, carotid arteries, cerebral arteries, vertebral arteries, renal arteries, iliac arteries, mesenteric arteries, arteries of the upper and lower limbs, and all the branches and veins of the aforementioned arteries and blood vessels), stents for the digestive system (e.g., esophagus, biliary tract, duodenum, colon, and pancreas), stents for the lungs (e.g., to maintain patency of the trachea, bronchi, bronchioles, or alveoli), stents for the head and neck (sinus, lacrimal duct, tympanic cavity), and stents for the urogenital system (e.g., ureters, urethra, fallopian tube, prostate).

[0014] In one aspect of the present invention, an assembly is provided comprising a stent and a sensor positioned on or inside the stent. Such a stent can be positioned in a wide variety of lumens, such as congenital internal passages (e.g., the vascular system, e.g., coronary, cervical, cerebral, and vertebral vessels, as well as renal, iliac, and various arteries of the lower extremities, pulmonary airways (e.g., trachea, bronchi, and bronchioles or other airways in the lungs including alveoli), digestive structures (e.g., esophagus, duodenum, small intestine, colon, biliary tract, and pancreatic duct), head and neck (sinus, lacrimal duct, middle ear ventilation tube), and urogenital (ureter, urethra, Fallopian duct, prostate)), surgically created internal passages (intracerebral shunts, spinal shunts, pulmonary shunts, hepatic shunts, ileal fistulas, colostomy tubes, surgical drains, middle ear ventilation tubes), and passages created or caused by trauma or disease processes.

[0015] According to various embodiments, the assembly includes a stent and one or more sensors disposed on or within the stent. Such sensors include, for example, one or more stents disposed on the outer wall of the stent, on the inner wall of the stent, and / or within the stent material itself. In related embodiments, one or more sensors may be disposed on the luminal surface, on the perivascular surface, and / or implanted within the stent or contained within the stent itself.

[0016] In the present invention, a wide variety of sensors can be utilized. Such sensors include, for example, fluid pressure sensors, contact sensors, position sensors, accelerometers, vibration sensors, pulse pressure sensors, blood volume sensors, blood flow sensors, blood chemistry sensors, blood metabolism sensors, mechanical stress sensors, and temperature sensors. In one embodiment, the sensor may be connected to other medical devices that can be used to deliver one or more types of drugs. In other embodiments, one or more sensors may be wireless sensors and / or sensors connected to a wireless microprocessor.

[0017] In a particularly preferred embodiment, a plurality of sensors are disposed on the stent. In still other embodiments, two or more types of sensors are disposed on the stent. In other related embodiments, the plurality of sensors are disposed on or within the stent at a sensor density of one or more, two or more, three or more, four or more, five or more, six or more, seven or more, eight or more, nine or more, ten or more, or twenty or more sensors per square centimeter. In other embodiments, the plurality of sensors are disposed on or within the stent at a sensor density of one or more, two or more, three or more, four or more, five or more, six or more, seven or more, eight or more, nine or more, ten or more, or twenty or more sensors per cubic centimeter. In any of these embodiments, fewer than 50, fewer than 75, fewer than 100, or fewer than 200 sensors may be provided per square centimeter or per cubic centimeter.

[0018] In other embodiments of the present invention, each assembly has a unique sensor or device identification number. In another embodiment, one or more (or each) of the sensors has a unique sensor identification number. In yet another embodiment, one or more (or each) of the sensors is uniquely defined within a specific location on or within the stent.

[0019] In yet another aspect of the present invention, an assembly is provided that includes a stent and one or more of the sensors provided herein, the sensor measuring or detecting one or more measurements of cardiac function, including, for example, cardiac output, stroke volume, ejection fraction, systolic blood pressure, diastolic blood pressure, mean arterial pressure, systemic vascular resistance, total peripheral resistance, temperature and / or restenosis, blood clotting or partial or complete occlusion of the lumen fluid flow within the patient's body. In another aspect of the present invention, an assembly is provided that includes a stent and one or more of the sensors provided herein, the sensor measuring or detecting surface (lumen) contact, the sensor being able to measure the degree / extent of healing (which, in the case of a vascular stent, is typically endothelialization) and the coating of the lumen surface of the stent by biological tissue, such information being available to the physician to determine whether the patient remains at risk of thrombosis and whether anticoagulation therapy needs to be continued.

[0020] In certain embodiments of the present invention, the stent is a drug-eluting stent, which may optionally be coated with one or more polymers or may include one or more polymers.

[0021] In another aspect of the present invention, the use of the assembly described herein is provided for the measurement of cardiac function (described herein) and / or for medical imaging and / or self-diagnosis of one or more aspects of cardiac function, disease, stent integrity and / or stent effectiveness.

[0022] In another aspect of the present invention, a method for monitoring a stent is provided, which includes the steps of: a) transmitting a wireless electrical signal from a location outside the human body to a location inside the human body; b) receiving the signal at a sensor located on a stent provided inside the human body; c) supplying power to the sensor using the received signal; d) detecting data at the sensor; and e) outputting the detected data from the sensor to a receiving unit provided outside the human body. In various embodiments, the stent can constitute any of the assemblies provided herein.

[0023] In other words, a non-transient computer-readable storage medium that configures a computer computing system to perform a method, the method comprising: a) identifying a patient, wherein the identified patient has at least one wireless stent, and each wireless stent has one or more wireless sensors; b) instructing a wireless query unit to collect sensor data from at least one of the one or more wireless sensors; and c) receiving the collected sensor data. In a particular embodiment, such a method may optionally further include: a) identifying a plurality of patients, wherein each identified patient has at least one wireless stent, and each wireless stent has one or more wireless sensors; b) instructing a wireless query unit associated with each identified patient to collect sensor data from at least one of the one or more wireless sensors; c) receiving the collected sensor data; and d) aggregating the collected sensor data. In yet another embodiment, such a method may optionally further include the steps of a) removing sensitive patient data from the collected sensor data and b) parsing the collected data according to the type of sensor. In related embodiments, the stored content includes the step of configuring a computer system to perform the method and the step of instructing a wireless query unit to perform the method and the step of instructing a control unit associated with the wireless query unit. Any of the assemblies, stents, and / or sensors described herein can be used in such a method.

[0024] In another aspect of the present invention, a method is provided for determining stent degradation, the method comprising: a) providing an assembly comprising a stent and one or more sensors positioned on the stent surface and / or at various depths within the biodegradable / bierosive stent to a patient's internal passage; and b) detecting changes in the sensors to thus determine the rate of degradation and / or complete degradation of the stent. In various embodiments, the sensors can detect one or more physiological (e.g., contact, fluid flow rate, pressure and / or temperature) and / or spatial (e.g., location within the patient's body) parameters. In another embodiment, the detection step is a series of detections over time, and optionally, the method may further include a step of determining the rate of degradation of the stent and / or estimating the time to complete degradation of the stent.

[0025] In yet another aspect of the present invention, a method is provided for imaging a stent or an assembly including a stent with sensors, the method comprising the step of detecting changes over time in sensors inside, on, and / or inside the stent, wherein the stent has sensors at a density of 1 or more, 2 or more, 3 or more, 4 or more, 5 or more, 6 or more, 7 or more, 8 or more, 9 or more, 10 or more, or 20 or more sensors per square centimeter. In another aspect, the stent has sensors at a density of 1 or more, 2 or more, 3 or more, 4 or more, 5 or more, 6 or more, 7 or more, 8 or more, 9 or more, 10 or more, or 20 or more sensors per cubic centimeter. In any of these embodiments, it is preferable that there be fewer than 50, fewer than 75, fewer than 100, or fewer than 200 sensors per square centimeter or cubic centimeter.

[0026] As described above, a wide variety of sensors can be used in the present invention, and such sensors include, for example, fluid pressure sensors, contact sensors, position sensors, accelerometers, vibration sensors, pulse pressure sensors, blood volume sensors, blood flow sensors, blood chemistry sensors, blood metabolism sensors, mechanical stress sensors, and temperature sensors. In various embodiments, the stent may be a vascular stent, a digestive stent, a lung stent, a sinus stent, or a urogenital stent, and may optionally be biodegradable, partially biodegradable, or non-biodegradable. In yet another embodiment, the sensor is a wireless sensor and / or a sensor connected to a wireless microprocessor. By imaging the sensor in this way, the integrity of the stent can be queried wirelessly, and the results can be reported periodically. This allows the patient's health to be checked periodically or at any time desired by the patient and / or physician.

[0027] Details of one or more embodiments are described in the following detailed description. Other features, other purposes and other advantages will be apparent from the description in the specification, the description in the drawings and the description in the claims. In addition, all patents and patent application publications cited herein are incorporated herein by reference and the entirety of their disclosures is part of this specification. [Brief explanation of the drawing]

[0028] [Figure 1] This is a diagram of an example stent equipped with sensors (such as blood flow sensors, pulse pressure sensors, position sensors or location markers and / or pH sensors). [Figure 2] This is a diagram of an example stent containing a sensor, illustrating the movement of blood through the stent. [Figure 3A] This is a diagram illustrating an example of a stent with various openings provided within the stent strut. [Figure 3B] This diagram shows the arrangement of one or more sensors within one of the openings in the strut. [Figure 4A]This diagram shows a branching point in a blood vessel where stenosis has occurred at multiple locations within the vessel. [Figure 4B] This is a diagram showing a stent equipped with PTCA. [Figure 4C] This diagram shows a stent-plus-stent configuration (also known as "inverted T"). [Figure 4D] This diagram shows the stent-plus-stent deployment configuration (referred to as "T-stent placement"). [Figure 4E] This diagram shows a stent-plus-stent deployment configuration known as a "crash." [Figure 4F] This diagram shows a stent-plus-stent deployment configuration, referred to as "Y" or "V". [Figure 4G] This diagram shows the stent-plus-stent deployment configuration, also known as the "kiss" configuration. [Figure 4H] This diagram shows the stent-plus-stent configuration, also known as "culottes." [Figure 5] This is a schematic diagram of a contact sensor that can be used to facilitate and / or assist in the placement of overlapping stents. [Figure 6] This figure shows medical imaging of vascular anatomical structures using sensors capable of detecting positional motion. [Figure 7] This figure shows medical imaging of the vascular system using a sensor capable of detecting positional motion caused by vascular pathological features. [Figure 8] This figure shows an embodiment of an information and communication technology system configured for processing sensor data. [Figure 9] This is a block diagram of a sensor, query module, and control unit according to one embodiment of the present invention. [Figure 10] This is a schematic diagram of one or more sensors placed on a stent inside a patient's body that are explored to obtain and output data in accordance with the present invention. [Modes for carrying out the invention]

[0029] As described above, stents are equipped with numerous sensors to monitor the precise placement and deployment of the stent within the body, the anatomical structure and pathological condition of the tissues surrounding the stent, the integrity and effectiveness of the stent, the normal and abnormal healing state of the tissues in contact with the stent, the function of the tissues and organ systems in contact with the stent, the degradation and dissolution of the stent (in the case of biodegradable stents), and stent rupture or impending rupture due to disease or other processes (e.g., restenosis, thrombosis, inflammation, benign or malignant tumor growth). However, before describing the present invention, it is helpful to first define certain terms used below for understanding the present invention.

[0030] A "stent" is a medical device that can be used to keep human body structures and / or internal passages open. Stents can be used to treat and / or prevent a wide variety of diseases and / or conditions resulting from luminal stenosis or obstruction, whether caused by trauma or external compression of the blood vessel wall (benign or malignant tumors, abscesses, cysts), disease processes occurring within the blood vessel wall (e.g., cancer, atherosclerosis, inflammation, scarring, or stenosis), and / or disease processes occurring on the surface of the blood vessel wall (or within the lumen) (e.g., thrombosis, atherosclerosis, restenosis, tumor growth, inflammation and scarring, gallstones, urinary stones, mucosal impaction, etc.), and / or caused by surgery or other medical interventions.

[0031] Stents are used in a wide variety of tubular internal passages to maintain the normal passage of intraluminal substances (blood, digestive contents, digestive enzymes and bile, air, urine, reproductive substances), such passages include, for example, vascular structures (e.g., coronary arteries, carotid arteries, cerebral arteries, vertebral arteries, iliac arteries, femoral arteries, popliteal arteries, tibial arteries, mesenteric arteries, pulmonary arteries, and other branches of these arteries), large veins (e.g., superior vena cava, inferior vena cava, veins of the neck, upper and lower extremities), and digestive tract structures. Examples include (e.g., esophagus, duodenum, small intestine, colon, biliary tract and pancreatic duct), lung structures (e.g., for maintaining the patency of the trachea, bronchi, bronchioles or alveoli), urinary system structures (urinary collection system, ureters, urethra), female and male reproductive system structures (e.g., for maintaining the patency of the Fallopian duct, urethra, and prostatic portion), cranial and intracranial sinus structures (maxillary sinus, frontal sinus, lacrimal duct), and inner ear structures (middle ear ventilation tubes), and inner ear structures (middle ear ventilation tubes).

[0032] Typically, stents are composed of metal or polymer components, and these stents may have a single structure or multiple components (e.g., a bifurcated stent system). Stents may be non-degradable, partially degradable, or completely degradable. In addition, stents may be coated with one or more different compositions, such as polymers and pharmaceuticals (including biological agents and stem cells). Representative examples of stents include U.S. Patent Nos. 6,852,153, 7,942,923, 7,753,947, 7,879,082, and 8,287,588, as well as various publications (for example, Craig S. Bonsignore, "Open Stent Design: Design and analysis of self-expanding cardiovascular stents," CreateSpace Independent Publishing Platform, November 2012, and Sigwart, Frank (eds.), "Coronary Stents" Examples include the stents disclosed in Springer, 2012.

[0033] According to a preferred embodiment, the stent of the present invention has a unique device identification number ("UDI"), and each of the sensors on the stent has a unique sensor identification number ("USI").

[0034] "Sensor" means an instrument that can be used to measure one or more different aspects of the human body, a stent inserted into the human body, and / or the integrity, impact, effectiveness, or effect of a stent inserted into the human body. Typical examples of sensors suitable for use in the present invention include, for example, fluid pressure sensors, contact sensors, position sensors, pulse pressure sensors, blood volume sensors, blood flow sensors, chemical sensors (e.g., for blood and / or other bodily fluids), metabolic sensors (e.g., for blood and / or other bodily fluids), accelerometers, mechanical stress sensors, and temperature sensors. In certain embodiments, the sensors may be wireless sensors, or in other embodiments, the sensors may be connected to a wireless microprocessor. In another embodiment, one or more (including all) of the sensors may have a unique sensor identification number ("USI") that specifically identifies the sensor.

[0035] A wide variety of sensors (also known as Microelectromechanical Systems, i.e., "MEMS," Nanoelectromechanical Systems, i.e., "NEMS," and BioMEMS or BioNEMS) are generally referred to as follows: https: / / en.wikipedia.org / wiki / MEMS(See [reference]) can be used in the present invention. Representative patent specifications and patent application specifications include U.S. Patent No. 7,383,071 and U.S. Patent Publication No. 2010 / 0285082. Representative publications include Albert Foch, "Introduction to BioMEMS," CRC Press, 2013; Marc J. Madow, "From MEMS to Bio-MEMS and Bio-NEMS: Manufacturing Techniques and Applications," CRC Press, 2011; Simona Badilescu, "Bio-MEMS: Science and Engineering Perspectives," CRC Press, 2011; and Steven S. Saliterman (Sreven) S. Saliterman), "Fundamentals of BioMEMS and Medical Microdevices," SPIE - The International Society of Optical Engineering, 2006, Wanjunn Wang, Steven A. Soper.Soper (ed.), "Bio-MEMS: Technologies and Applications," CRC Press, 2012; Volker Kempe, "Inertial MEMS: Principles and Practice," Cambridge University Press, 2011; Polla, DL et al., "Microdevices in Medicine," Annual Review of Biomedical Engineering (Ann. Rev. Biomed. Eng.), 2000, Vol. 2, pp. 551-576; Yun, KS et al. al.), "A Surface-Tension Driven Micropunp for Low-voltage and Low Power Operations," Journal of Microelectromechanical Systems, October 2002, 11:5; Yeh, R. et al., "Single Mask, Large Force, and Large Displacement Electrostatic Linear Inchworm Motors," Journal of Microelectromechanical Systems, August 2002, 11:4, pp. 330-336; Loh, NC et al., "Sub-10cm." 3Interferometric Accelerator with Nano-G Resolution (Sub-10cm) 3 "Interferometric Accelerometer with Nano-g Rsolution," Journal of Microelectromechanical Systems, June 2002, 11:3, pp. 182-187. All of these publications are cited by reference and their entire contents are incorporated herein by reference.

[0036] To further understand the various aspects of the present invention provided herein, the following sections are provided below: A. Stents and stent use; B. Stents housing sensors; C. Stent placement, deployment and connection; D. Partially or entirely biodegradable stents; E. Stent coatings; F. Drug-eluting stents; G. Methods for monitoring infection within stents; H. Separate use of sensor-housing stents in healthcare; I. Power generation from stents; J. Medical imaging and self-diagnosis, predictive analysis and predictive maintenance of stent-containing assemblies; K. Methods for monitoring stent-containing assemblies; and L. Collection, transmission, analysis and distribution of data from stent-containing assemblies.

[0037] A. Stent and stent usage As mentioned above, stents are used to open and maintain the lumen of diseased internal passages (e.g., arteries, gastrointestinal tract, urinary tract), but they have been found to be most frequently used in the vascular system. Simply put, stents are best inserted into internal lumens to physically maintain the patency of structures and / or passages (typically tubular organ structures, e.g., blood vessels, gastrointestinal tract, urinary tract, intracranial sinuses, airways, or male and female reproductive tracts) that have become closed or partially occluded, thereby reducing or blocking the passage (typically the passage of fluids, solids, or air). Stents are usually placed percutaneously (e.g., a vascular stent is inserted into the vascular system through the femoral artery in the groin, then manipulated in the bloodstream under X-ray guidance until the stent reaches the diseased vessel) or by insertion through a congenital opening (e.g., mouth, nose, anus), and then placed into the affected organ under direct visualization (endoscopic method). In most cases, stents are delivered to the deployment site in a compressed form and then expanded in place (often by inflating a balloon or by using a "self-expanding" stent), thereby opening the organ lumen and returning it to its original size and shape. Symptoms of closure or obstruction (e.g., chest pain, claudication, neurological defects, dysphagia, bowel obstruction, jaundice, dyspnea, infertility, urinary tract obstruction, sinus pain) are determined by the diseased organ, and the goal of stent treatment is the restoration of normal anatomical structure and lumen function. Stent rupture can be due to a number of causes, including situations such as improper placement, improper sizing, incomplete opening or deployment, tissue growth into the stent lumen (restenosis, tumor cell growth, inflammation), lumen obstruction (blood clots, gallstones, kidney stones), stent rupture, stent entanglement, and stent migration. Stent placement sensors that can assist physicians in proper placement and stents that can be continuously monitored to detect evidence of partial and / or complete occlusion offer significant advantages compared to existing devices.

[0038] Figure 1 shows a typical stent with sensors housed within it. Figure 2 shows a configuration where some of the sensors are positioned in a location exposed to the blood flowing through the stent. A wide variety of sensors can be placed on the inner wall (lumen wall) of the stent, inside the stent, and / or on the outer wall (paralumen wall) of the stent. Typical sensors that can be used inside the stent include fluid pressure sensors, contact sensors, position sensors, pulse pressure sensors, blood volume sensors, blood flow sensors, blood chemistry sensors, blood (and tissue) metabolism sensors, accelerometers, mechanical stress sensors, vibration sensors, and temperature sensors.

[0039] In various embodiments, the vascular stents (coronary, peripheral, and cerebral vessels) of the present invention are preferably equipped with various sensors capable of detecting and distinguishing between stenosis, restenosis, and / or thrombosis and normal vascular healing. Blood flow sensors, fluid pressure sensors, and blood volume sensors placed on the lumen surface can detect the presence and location of stenosis due to an increase in blood flow velocity and blood pressure (and pulse pressure) (relative to normal pressure) at the site of stenosis. Stenosis due to neointima-hyperplasia or agglutination may be detected as a "dead spot" and / or change in reading on the vascular surface when the blood flow sensors, blood metabolism sensors, and / or blood chemistry sensors are covered by vascular tissue or blood clots, while paraluminal pressure sensors and accelerometers do not show changes in paraluminal pressure or stent wall deformation. Metabolic or chemical sensors can determine the difference between stenosis (normal pH and physiological reading) and agglutination (decreased pH and change in physiological reading). Finally, complete coverage of the stent lumen surface in the absence of changes in pressure, blood flow, stent deformation, and metabolic / chemical properties suggests normal healing, and the stent is endothelialized (covered with cells that line the blood vessels of the human body). This indicator of healthy and complete integration of the stent into the vessel wall (i.e., the stent is no longer exposed to elements of blood flow) has important clinical implications—it draws attention to the possibility of discontinuing the patient's (costly and dangerous) anticoagulation therapy, because the risk of subacute and delayed thrombosis is now significantly reduced. In the case of biodegradable stents, complete coverage of the stent lumen surface and integration of the stent into the vessel wall means that stent dissolution is now safe (i.e., stent fragments will not be released into the bloodstream).

[0040] Furthermore, patients requiring stents often suffer from pervasive cardiovascular diseases that result in cardiac and systemic circulatory failure. For example, patients who have undergone stent placement are at high risk of myocardial infarction (heart attack), cerebrovascular accident (attack), congestive heart failure, renal failure, and arrhythmias. The coronary arteries are crucial to cardiac function, and therefore, monitoring certain hemodynamic and metabolic parameters within these arteries can provide physicians with extremely important information regarding the patient's cardiac, renal, and circulatory function. The coronary stent of the present invention preferably includes fluid pressure sensors, contact sensors, position sensors, pulse pressure sensors, blood volume sensors, blood flow sensors, blood chemistry sensors, blood metabolism sensors, accelerometers, mechanical stress sensors, temperature sensors, etc., suitable for this purpose. Representative stents of the present invention can be used by those skilled in the art to calculate and monitor important physiological parameters, such as cardiac output (CO), stroke volume (SV), ejection fraction (EV), systolic blood pressure (sBP), diastolic blood pressure (dBP), mean arterial pressure (mAP), systemic vascular resistance (SVR), total peripheral resistance (TPV), and pulse pressure (PP). For example, FloTrac / Vigileo (Edwards Life Sciences, Irvine, California) uses pulse contour analysis to calculate stroke volume (SV) and systemic vascular resistance (SVR), and pressure recording analysis (PRAM) is used by Most Care (Padra Vitec, Italy) to estimate cardiac output (CO) from the analysis of arterial pressure waveforms. Changes in cardiac output (CO), stroke volume (SV), and ejection fraction (EF), as well as cardiac index (CI), are important in detecting complications such as myocardial ischemia and myocardial infarction, and can also help physicians concretize and adjust cardiac medications and dosages. The pulse pressure sensors, pulse contour sensors, and heart rate sensors installed on and inside the stent of the present invention can help detect and monitor cardiac arrhythmias and heart rate abnormalities, and these sensors can also be used to monitor the patient's response to cardiac medications that affect heart rate and rhythm.Readings of systolic blood pressure (sBP), diastolic blood pressure (dBP), mean arterial pressure (mAP), systemic vascular resistance (SVR), and total peripheral resistance (TPV) can be used by physicians to monitor the dosage and effects of antihypertensive and vasopressor (blood pressure increasing) drugs. Clearly, peripheral and cerebral vascular stents implanted in other arteries (renal arteries, iliac arteries, femoral arteries, carotid arteries, etc.) can also monitor virtually all of the above parameters.

[0041] The vascular stent of the present invention preferably has a cardiovascular sensor (described herein) suitable for monitoring renal function, as well as a blood chemistry sensor and a blood metabolism sensor. Examples of blood chemistry and metabolic sensors useful in this embodiment include, but are not limited to, blood urea nitrogen (BUN) sensors, creatinine (Cr) sensors, and electrolyte (calcium, potassium, phosphorus, sodium, etc.) sensors. Furthermore, by combining metabolic data with hemodynamic data and urinalysis results, physicians can calculate glomerular filtration rate (GFR), a highly useful measure of renal function. This information is particularly useful in the management of dialysis patients to monitor the timing, effectiveness, and frequency of dialysis therapy.

[0042] In one embodiment of the present invention, the stent may further have one or more temperature sensors. These sensors can be used to track both the separate temperatures of the blood, the blood vessel wall, and the surrounding environment, as well as the temperature changes over time. Such temperature changes can be used to diagnose the risk of infection (or other disease or condition) and to enable a physician or caregiver to treat the infection (or other disease or condition) before it becomes fully apparent.

[0043] B. Stent containing sensors As described above, in various aspects of the present invention, the sensors described herein are preferably housed within a stent, such as, for example, within a hole in the strut of the stent or within the strut itself. The term “hole” as used herein should be understood to include openings that extend completely through the stent, as well as other openings or partial openings that allow insertion of a sensor within the stent, such as a cavity, recess, well, or other opening. Typical examples of stents include those described in U.S. Patent Nos. 7,208,010 and 7,179,289.

[0044] For example, as shown in Figure 3A, a typical stent has various holes provided in the stent strut. Figure 3B shows the arrangement of one or more sensors housed in one of the openings in the strut.

[0045] C. Stent placement, deployment, and connection In certain embodiments, the stents of the present invention can provide detection information useful for various important clinical functions. It is widely recognized that the greater the amount of trauma the vascular wall suffers during stent placement and deployment, the higher the probability that the stent will eventually become occluded (for example, due to restenosis). Causes of vascular trauma during placement include inaccurate sizing (stents that are too large for the vessel), difficult placement and deployment (requiring extensive manipulation to place the stent), long lesions, overlapping stents, balloon over-inflation or stent over-expansion, complex lesions (including stent placement at bifurcations), and placement of stents in winding vessels. Precise placement, sizing, deployment, and adequate stent expansion remain challenges, particularly in the vascular system, where indirect visualization techniques, such as angiography, are primarily used for stent placement. However, angiography (in which radiopaque dyes flow through the bloodstream) only reveals the anatomical structure of the vascular lumen and does not provide information about abnormalities in the vessel wall (which are often segments with significant disease during treatment). Real-time detection information from the stent itself is useful for physicians when deciding on stent placement, and even just listing a few important functions, it is useful for physicians when placing a stent to determine whether the stent is anatomically correct, whether the stent is appropriately sized for the outcome of stent placement, whether the stent fully opens (deploys) during balloon expansion (or self-expansion), whether the stent exerts too much (or too little) pressure on the vessel wall, whether the stent segments are correctly assembled, whether the amount of overlap between adjacent stents is optimal, whether there is stent entanglement or deformation, whether there is stent cracking or breakage, and whether there is uniform flow through the instrument. With the stent of the present invention, physicians during surgery can monitor many beneficial parameters that can result in good and less traumatic stent placement and deployment.

[0046] Improper sizing of the stent relative to the vessel wall in which it is housed can significantly increase the risk of rupture (particularly due to restenosis), and stents equipped with sensors that can detect the amount, presence, and / or absence of pressure against the vessel wall and the amount of contact with the vessel wall can help match the stent size and degree of expansion (deployment) to the size of the vessel wall. All or partial incomplete opening of the stent (called incomplete malapposition—areas where the stent is not in sufficient contact with the vessel wall and protrudes into the lumen of the ductus arteriosus) increases the risk of subsequent blood clotting (thrombosis) and stent rupture, and position sensors, contact sensors, and accelerometers provided on the stent can be used to identify and correct areas of incomplete opening (deployment) during stent insertion, and "locking" to a fully open position can be confirmed by sensors provided on and within the instrument. Improper positioning of the stent (mispositioning) is also a common complication of stent therapy, either at the time of deployment or due to subsequent movement / movement. The sensor-containing stent of the present invention can be used to confirm proper initial placement and the resulting movement or displacement within the blood vessel. Movement of the stent as a whole or detachment of individual stent segments from one another is another troublesome issue in stent insertion and current therapies. The stent of the present invention has the ability to detect movement / detachment of the entire stent as well as movement and / or detachment of individual segments (or fragments), providing useful diagnostic information to physicians and patients. Stent entanglement as a result of subsequent movement during and / or after deployment is also a significant clinical issue if it occurs. The stent of the present invention has position sensors and accelerometers distributed throughout the stent that can detect deformation and entanglement of the stent. Stent cracking and rupture are problems with all stents, but can be particularly problematic with peripheral stents in the lower extremities (due to movement of the lower extremities or bending of the stent throughout the knee joint) and with polymer degradable stents.Vibration sensors, position sensors, location sensors, and accelerometers installed throughout the device can warn physicians and patients of the occurrence of this complication before it develops into an emergency.

[0047] In various aspects of the present invention, an assembly is provided in which a stent may consist of an integrated component combined with another stent, or a number of components that need to be arranged in an appropriate manner to ensure proper utility. When a patient has arterial disease and vascular stenosis at a bifurcation in the vascular dendritic structure, it is often necessary to use a stent (or stent component) that can be positioned in situ to match the anatomical structure of the occluded segment. For example, Figure 4 is a schematic diagram of various types of stent placement examples, in which a contact sensor can be used to ensure proper stent placement. Figure 4A shows a bifurcation in which stenosis occurs at multiple locations in the vessel. Figure 4B shows a stent with PTCA. Figure 4C shows a stent-plus-stent configuration (also called "reverse-T"). Figure 4D shows a stent-plus-stent configuration (called "T-stenting"). Figure 4E shows a stent-plus-stent configuration called "Crush". Figure 4F shows a stent-plus-stent deployment configuration called "Y" or "V". Figure 4G shows a stent-plus-stent deployment configuration called "kissing". Figure 4H shows a stent-plus-stent deployment configuration called "Culotte". In each case, using contact sensors (potentially "matched" or complementary) allows verification of the correct assembly, using accelerometers allows verification of anatomical location and structure, position sensors allow monitoring of movement, flow sensors allow verification of vascular patency, and pressure / vascular wall sensors allow verification of complete deployment and accurate vessel size. In short, this detection information can create a three-dimensional image of the anatomical structure of the vessel and stent, thus significantly improving the data available from angiography alone. This dramatically increases the likelihood of accurate, safe, and effective deployment of multiple stents within complex vascular lesions.

[0048] Figure 5 is a schematic diagram of a contact sensor that can be used to facilitate and / or assist in the placement of overlapping stents. Overlapping stents are used to treat long or winding lesions where a single stent is insufficient to span the entire length of the diseased segment. While often effective, overlapping stents are more prone to failure, and the failure rate is directly proportional to the degree of overlap between adjacent stents. Too much overlap increases the risk of failure, and too little overlap—especially if there is a gap between the two stents—is equally problematic. Using stent-to-stent contact sensors allows for the detection of both the presence and degree of overlap between adjacent stents. In a preferred embodiment, the stent-to-stent contact sensors are “matched” or complementary, allowing for the determination of the point at which an ideal amount of overlap between adjacent stents has been reached. Furthermore, by using pressure sensors, position sensors, and accelerometers, it is possible to verify that overlapping segments are equally positioned to ensure that there is no lumen size "mismatch" between the two overlapping segments.

[0049] D. Partial or fully biodegradable stents As described above, the stents of the present invention (for blood vessels (e.g., coronary arteries, carotid arteries, cerebral arteries, vertebral arteries, iliac arteries, femoral arteries and arteries of the lower extremities), for the digestive system (e.g., esophagus, duodenum, colon, biliary tract and pancreas), for the lungs (e.g., to maintain patency of the trachea, bronchi, bronchioles or alveoli), for the head and neck (sinus, lacrimal duct, tympanic cavity), and for the urogenital system (e.g., ureters, urethra, prostate, fallopian tube)) are preferably composed of one or more biodegradable polymers. Such stents are preferably fully or partially biodegradable and / or reabsorbable. Typical examples of such stents include, for example, the stents described in U.S. Patent Publication Nos. 2009 / 0192588, 2007 / 0270940, and 2003 / 0104030, and U.S. Patent Nos. 6,387,124, 6,869,443, and 7,044,981.

[0050] The arrangement of sensors described herein on or inside a biodegradable or partially biodegradable stent (at various depths within the polymer) allows for the determination of stent degradation and, optionally, the measurement of the stent's biodegradation or reabsorption rate. Therefore, in one aspect of the present invention, a method is provided for determining stent degradation, comprising: a) providing an assembly comprising a stent and one or more sensors positioned on the stent surface and / or at various depths within the biodegradable / biodegradable stent to a patient's internal passage; and b) detecting changes in the sensors to determine the rate of stent degradation and / or complete degradation. In various embodiments, the sensors can detect one or more physiological (e.g., contact, fluid flow rate, pressure and / or temperature) and / or spatial (e.g., location within the patient's body) parameters. In another embodiment, the detection step is a series of detections over time, and optionally, the method may further include a step of determining the rate of stent degradation and / or estimating the time to complete stent degradation. In yet another embodiment, the stent can determine the degree of lumen coverage of the device by healing tissue, and thus confirm that the stent is implanted within the blood vessel wall (reducing or eliminating the risk of stent fragments being released into the luminal fluid).

[0051] In one embodiment, the biodegradable stent is an esophageal stent, a ureteral stent, a urethral stent, a sinus stent, a vascular stent, or a prostate stent, and the deterioration of the stent can be monitored by detecting the disappearance or movement of a sensor over a period of time.

[0052] E. Stent coating In certain embodiments of the present invention, a stent is provided which has one or more coatings applied to one or more surfaces of the stent. The coatings are preferably provided on the stent for various purposes. The coatings may be biodegradable, non-biodegradable, or a combination thereof. Typical examples of coatings are those mainly composed of polymers (e.g., polymers composed of polyurethane, polyester, polylactic acid, polyamino acids, polytetrafluoroethylene, Teflon®, Gore-Tex®), but non-polymer coatings can also be used.

[0053] Typical examples of suitable coatings include, for example, the coatings described in U.S. Patent Nos. 8,123,799, 8,080,051, 8,001,925, 7,553,923, and 5,779,729, all of which are incorporated herein by reference and whose entire contents constitute part of this specification.

[0054] F. Drug-eluting stent In certain embodiments of the present invention, the stents provided herein are preferably designed to elute one or more agents (e.g., biologically active agents). Typical examples include U.S. Patent No. 5,716,981, U.S. Patent Application Publication No. 2005 / 0021126, and U.S. Patent Application Publication No. 2005 / 0171594 (Title of Invention: Stents with bioactive coatings) and U.S. Patent Application Publication No. 2005 / 0181005, and U.S. Patent Application Publication No. 2005 / 0181009 (Title of Invention: Implantable sensors and implantable pumps and anti-scarring agents), all of which are incorporated herein by reference and whose entire contents are incorporated herein by reference.

[0055] Therefore, various embodiments of the present invention provide a drug-eluting stent (e.g., a drug-coated stent) having one or more sensors and capable of releasing a desired agent (e.g., a drug or therapeutic agent) to a desired location in the body (e.g., a body lumen and / or blood vessel wall). In related embodiments, the drug-eluting delivery device is preferably provided within the stent to release the desired drug when requested (e.g., remotely activated / on-demand or at a timed schedule, for which generally see U.S. Patent Application Publication 2011 / 0092948 (Title of Invention: Remotely Activated Piezoelectric Pump For Delivery of Biological Agents to the Intervertebral Disc and Spine), which is hereby cited by reference and whose entire contents are incorporated herein by reference) or when an activation event is detected (e.g., leakage detection by a pressure sensor). For example, in certain embodiments of the present invention, it is preferable to administer or release a biological agent together with the stent to treat or prevent a disease (e.g., i) together with a chemotherapeutic agent in the case of cancer or to prevent restenosis, ii) restenosis prevention agents, such as taxanes or limus agents, in the case of restenosis prevention, or iii) together with an antibacterial agent in the case of infection).

[0056] In a preferred embodiment, one or more sensors (e.g., pressure sensors, contact sensors, and / or position sensors) can be used to determine the proper placement of the desired drug, as well as the amount of drug to be released to the desired site and the kinematic characteristics of the release.

[0057] G. Methods for monitoring infection In other embodiments, a stent having one or more temperature sensors is provided. Such a stent can be used to measure the temperature of the blood, the temperature of the blood vessel or lumen wall, the temperature of the stent, the temperature within local tissue, and the temperature of the surrounding environment adjacent to the stent. Methods are also provided for monitoring temperature changes over time to determine if an infection may be imminent and / or to issue a warning (e.g., to the patient and / or healthcare provider).

[0058] In certain embodiments of the present invention, metabolic and physical sensors may also be placed on or within the stent, or on or within various components of the stent, to monitor for rare but potentially life-threatening complications. In some patients, the stent and the surrounding tissue may become infected. Sensors, such as temperature sensors (to detect temperature increases), pH sensors (to detect pH decreases), and other metabolic sensors, may be used to indicate the presence of infection on or around the stent. For example, temperature sensors may be placed on or within the stent to enable early detection of infection and allow for proactive treatment with antibiotics or surgical intervention.

[0059] H. Separate use of sensor-containing stents in health management Sensors and any associated medical devices attached to a stent offer various advantages in both healthcare and non-healthcare settings (e.g., at home or in the workplace). For example, postoperative progress can be monitored (readings can be compared daily, weekly, etc.), information can be compiled and shared with both the patient and the attending physician, thereby allowing for sequential rehabilitation follow-up and comparison with expected (typically age-group) benchmarks. In certain embodiments, a wearable device queries the sensor in a selected or randomized manner to capture and / or store the collected sensor data. This data can then be downloaded to another system or device (as described in detail below).

[0060] By integrating data collected by the sensors described herein (e.g., contact sensors, position sensors, strain gauges, and / or accelerometers) using simple and widely available commercially available analytical techniques, such as pedometers and Global Positioning System (GPS) functions, it is possible to collect even more clinically important data, such as the extent of the patient's walking (time, distance, steps, speed, gait), the patient's activity level (frequency, duration, intensity of activity), exercise tolerance (work, calories, power, training effect), range of motion (described later), and prosthesis performance under various "real-world" conditions (but not limited to these). It is difficult to exaggerate the values ​​of this information when enabling good management of the patient's recovery. The attending physician (or physical therapist, rehabilitation specialist) only observes the patient intermittently during scheduled visits, and many non-corresponding factors can affect the patient's function at the precise moment of examination. These factors include, to name just a few, the presence or absence of pain, inflammation, stiffness, time of day, compliance and timing of medication use (pain medications, anti-inflammatory drugs), recent activity and exercise levels, patient endurance, mental state, language barriers, characteristics of the physician-patient relationship, or the patient's ability to accurately describe their symptoms. Continuous monitoring and data collection allow patients and physicians to objectively monitor progress by providing information on the patient's function under a variety of conditions and circumstances, thereby evaluating how performance has been affected by various interventions (pain control, exercise, physiotherapy, anti-inflammatory drugs, inhalation, etc.) and comparing the rehabilitation progress with past and future expected function. Good treatment decisions and good patient compliance can be expected when both physicians and patients benefit from observing the impact of various treatment modes on the patient's rehabilitation, activity, function, and overall performance.

[0061] I. Electricity generation In certain aspects of the present invention, it is preferable that one or more small electrical generating units be arranged inside, within, and / or on the stent. Briefly, various techniques for extracting power from slight mechanical motion or vibration are described. For example, this can be seen in the papers "Piezoelectric Power Scavenging of Mechanical Vibration Energy" by UK Singh et al., Australian Mining Technology Conference, October 24, 2007, pp. 111-118, and "Next Generation Micro-power Systems" by Chandrakasan et al., Symposium on VLSI Circuits Digest of Technical Papers, 2008, pp. 1-5. See also U.S. Patent No. 8,283,793 (Title of Invention: Device for Energy Harvesting within a Vessel) and U.S. Patent No. 8,331,632 (Title of Invention: Devices, Methods and Systems for Harvesting Energy in the Body). All of these prior art documents are incorporated herein by reference, and their entire contents are incorporated herein by reference. These cited documents provide examples of different types of power scavengers that can generate electricity from very little movement and store it for later use. The cited documents also describe embodiments that do not require movement, but rather generate electricity as a result of applying or removing pressure to a particular structure.Furthermore, these cited documents describe embodiments in which electricity can be generated from pulsating forces within the body.

[0062] Electricity is generated by one or more electric generators and then transmitted to any one of the various sensors described herein. For example, the electricity may be transmitted to the illustrated sensor. This electricity may also be transmitted to other sensors described later herein. Power transmission can be carried out by any acceptable technique. For example, if the sensor is physically coupled to a stent, a wire may be extended from the electric generator to the specific sensor. As a variation, electricity can be transmitted wirelessly in the same way that a wireless smart card receives power from a power source located in immediate vicinity using appropriate transmitting and receiving antennas. Power-dependent transmitting and receiving techniques are also described in the aforementioned publications, published patent applications and issued U.S. patents, all of which are incorporated herein by reference.

[0063] J. Medical imaging, self-diagnosis, predictive analysis, and predictive maintenance of stent-containing assemblies. The present invention provides a stent that can be imaged by the use of sensors under a wide variety of conditions. For example, according to various aspects of the present invention, a method is provided for imaging a stent or an assembly including a stent equipped with sensors, the method comprising the step of detecting changes in sensors within, on and / or inside the stent over time, wherein the stent has sensors at a density of 1 or more, 2 or more, 3 or more, 4 or more, 5 or more, 6 or more, 7 or more, 8 or more, 9 or more, 10 or more, or 20 or more sensors per square centimeter. In other aspects, the stent has sensors at a density of 1 or more, 2 or more, 3 or more, 4 or more, 5 or more, 6 or more, 7 or more, 8 or more, 9 or more, 10 or more, or 20 or more sensors per cubic centimeter. In any of these embodiments, it is preferable that there be fewer than 50, fewer than 75, fewer than 100, or 100 sensors per square centimeter or cubic centimeter. As described above, a variety of sensors can be used in the present invention, and such sensors include, for example, fluid pressure sensors, contact sensors, position sensors, pulse pressure sensors, blood volume sensors, blood flow sensors, blood chemistry sensors, blood metabolism sensors, mechanical stress sensors, and temperature sensors.

[0064] For example, using a stent having the sensors described herein, the anatomical structure of the blood vessel and the structure of the stent can be imaged by sensors capable of detecting positional motion. The sensors used may further include an accelerometer and a motion sensor for detecting stent movement due to heartbeat or other physical changes. Changes in position over time of the accelerometer and / or motion sensor can be used as measurements of changes in position over time of the stent wall and / or blood vessel wall. Such positional changes can be used as surrogate markers of the anatomical structure of the blood vessel and the structure of the stent—that is, such positional changes can form an "image" of the stent and / or blood vessel wall to provide information regarding the dimensions, shape and location of restenosis within the stent, the dimensions, shape and location of blood clot formation, tumor growth, abscess formation, atheroma plaque formation, stent twisting, stent rupture, segmentation or separation of bifurcated stents, the amount of overlap of overlapping stents, and / or stent movement / migration.

[0065] For example, as shown in Figure 7, a medical imaging method of the vascular system is illustrated by a sensor that can detect pathological features of blood vessels, such as positional motion resulting from restenosis or thrombus formation. By imaging a stent in this way, the integrity of the stent can be periodically checked wirelessly and the results reported. This allows for periodic checks of the patient's health or at any time desired by the patient and / or physician, thus enabling predictive diagnosis and / or predictive maintenance or prevention of stent problems.

[0066] Next, a specific exemplary embodiment will be described in detail. One particular advantage is the raw and in-situ monitoring of the recovery of the patient in whom the stent has been implanted. The sensors described herein collect data in a constant manner during normal daily activities and, if necessary, even at night. For example, a contact sensor may acquire and report data once every 10 seconds, once every minute, or once a day. Other sensors may collect data more frequently, for example, several times per second. For example, temperature, contact, and / or location data may be expected to be collected and stored several times per second. Other forms of data may only need to be collected on a minute-by-minute or hour-by-hour basis. Another sensor can collect data only when notified by the patient as part of an "event record"—that is, when the patient experiences a specific event (e.g., pain, trauma, etc.)—by an external signal generator / trigger device, and send a signal to the instrument to obtain a reading at that time, with the aim of enabling a comparison of subjective / symptomatic data with subjective / sensor data in an attempt to better understand the underlying cause or trigger of the patient's symptoms.

[0067] In certain cases, the stent is sized to accommodate one or more processor circuits, CPUs, memory chips and other electrical circuits, as well as antennas for transmitting and receiving data, and has more than enough space for such purposes. In other embodiments, the medical device in question may accommodate one or more processor circuits, CPUs, memory chips and other electrical circuits, as well as antennas for transmitting and receiving data. The processor is preferably programmed to collect data from various sensors on a schedule of any choice set by the medical professional. It is preferable to continuously monitor all actions postoperatively and collect data to store in memory provided within the stent.

[0068] Patients with stents typically undergo regular health checkups. When a patient visits a doctor's office for a checkup, the doctor places a reader in close contact with the stent, the stent illustrated in this embodiment, to transfer data from the internal circuitry within the stent to a database in the doctor's office. The use of wireless transmission using smart cards or other technologies is well known in the art and does not require further explanation. Embodiments of such wireless data transmission are described in the published U.S. patent applications and U.S. patent specifications described herein. The collected data (e.g., collected over a short period, several weeks, or even several months) is transferred over several months from the memory located within the stent to the doctor's computer or wireless device. The computer then analyzes the data to determine whether there are any abnormalities, whether there are any unexpected changes over time, whether there are any good or bad trends, and whether there are any other signs indicating the patient's health and the stent's functionality. For example, if a patient decides to ski or jog, the doctor can monitor the effects of such activity on the stent, such effects including changes during the activity. Next, the physician can examine the integrity of the stent in the hours and days following the event and compare it with data prior to the event to determine whether any particular event caused long-term damage or whether the activity applied forces to the stent exceeding the manufacturer's performance specifications for that particular stent. Data can be collected and compared with the current and long-term performance of the stent from strain gauges, contact sensors, surface wear sensors, or other sensors, if present. A representative example of an electronic data capture, documentation and clinical decision support system (EDDS) is described in International Publication No. 2012 / 061825, which is incorporated herein by reference and whose entire contents are part of this specification.

[0069] In one variation, the patient may also have such a reader at home, which periodically verifies data from the stent, for example, once a day or once a week. As mentioned above, the patient can also "trigger" the device reading (by an external signal generator / trigger device) as part of an "event record." By empowering patients to continue their own rehabilitation—and enabling them to recognize the positive (and negative) effects of various lifestyle choices on their health and rehabilitation—it is expected that compliance and patient outcomes will improve. Furthermore, patients can share their experiences with other patients via the web, thereby drawing their attention to signs and symptoms that should attract the patient's physician's attention when comparing their progress to expected "standards" regarding function and rehabilitation. The performance of different stents can be compared across different patients (different sexes, weights, activity levels, etc.), which helps manufacturers design better devices and helps surgeons and other healthcare providers select the right stent for specific patient types. Payers, patients, manufacturers, and physicians can all benefit from the collection of this comparative information. Finally, data collected at home can be sent to a doctor's clinic via the internet for analysis, potentially eliminating unnecessary visits in some cases and facilitating faster medical follow-up in others.

[0070] K. How to monitor a stent As described above, the present invention also provides a method for monitoring one or more of the stents provided herein. For example, Figure 8 shows a monitoring system 20 that can be used in conjunction with a stent 14 of the form shown in any one of Figures 1, 2, 3, 4, 5, 6, or 7. The monitoring system 20 includes a usable sensor 22, an inquiry module 24, and a control unit 26. The sensor 22 is of a passive wireless type that can operate on power received from a wireless source. Such sensors of this type are well known and widely used in the art. A good example of this type of pressure sensor is a MEMS pressure sensor, for example, part number LPS331AP, which is commercially available on the open market from STMicroelectronics. MEMS pressure sensors are well known to operate on very little power and are suitable for remaining unpowered and idle for extended periods. These pressure sensors can be wirelessly powered via RF signals. Based on the power received wirelessly via RF signals, these pressure sensors detect pressure and then output the detected data.

[0071] In one embodiment, an electrical generation system is provided that can be used to supply power to the sensors described herein (e.g., fluid pressure sensors, contact sensors, position sensors, pulse pressure sensors, blood volume sensors, blood flow sensors, blood chemistry sensors, blood metabolism sensors, accelerometers, mechanical stress sensors, temperature sensors, etc.). For example, the power generation system may utilize pulsating blood flow in a blood vessel. After generating electricity with one or more electrical generators or power generators, the electricity is sent to any one of the various sensors described herein. For example, power transmission can be carried out by any acceptable technique. For example, the electrical generator can be directly connected to one or more sensors by wires. Alternatively (or additionally), electricity can be transmitted wirelessly in the same way that a wireless smart card receives power from an adjacent power source using appropriate transmitting and receiving antennas.

[0072] During operation, as shown in Figure 8, the query module 24 outputs a signal 28. Signal 28 is a wireless signal (e.g., an RF band wireless signal) which contains power for the sensor 22 and a query request for the sensor 22 to perform detection. When queryed by signal 28, the sensor 2 activates and stores enough power in an onboard capacitor to maintain operation during detection and data reporting. Such power receiving circuits and power storage in onboard capacitors are well known in the art and therefore do not need to be shown in detail. Proper detection is performed by the sensor 22, and the data is then output from the sensor and returned to the query module 24 in the form of a signal 30, which is received at the input port of the query module.

[0073] In one embodiment, the initial signal 28 is provided with sufficient signal strength to supply power to the sensor, perform a detection operation, output a signal, and return it to the query module 24. In another embodiment, two or more signals 28 are sent, each providing sufficient additional power to the sensor to complete the detection operation, and then to transmit the data through the signal path 30 and return it to the query module 24. For example, the signal 28 may be sent continuously with a detection request component in the first part of the signal, and then power may be provided as either a stable signal or a pulse to operate the sensor. When the sensor is ready to output data at any time, the sensor may send a warning signal to the query module 24 indicating that data is arriving and turn off the signal 28 to avoid interference. In a modified example, the query signal 28 may be in a first frequency state, and the output signal 30 may be in a second frequency state that is sufficiently far apart so that these signals do not interfere with each other. In a preferred embodiment, both of these signals have the same frequency, and as a result, the same antenna of the sensor can receive signal 28 and transmit signal 30.

[0074] The query signal 28 may contain data for selecting a specific signal provided on the stent. For example, the signal 28 may activate all sensors on the stent simultaneously, then send requests for data from each at different selected times, so that one query signal 28 is provided for a set duration, for example, 1 to 2 seconds, so that each sensor on the stent collects data during this period, and then at the end of the period, the data is reported at different times over the next 0.5 to 2 seconds with each signal 30, so that data is collected from all sensors 22 with one query signal 28.

[0075] The query module 24 operates under the control of a control unit 26, which includes a microprocessor for the controller, memory, I / O circuits for interfacing with the query module, and a power supply. The control unit outputs data to a computer or other device, thereby making it available for use by a physician to display and treat a patient.

[0076] Figure 9 shows the operation of an embodiment of the present invention within a patient's body. The patient has epidermis 32. The stent, placed in one of the heart's blood vessels, is located inside the patient's body. The stent 14 can be placed in any one of many locations within the patient's body. In this embodiment, the stent is a coronary stent placed in the patient's coronary artery (left anterior descending artery), but stents in other blood vessels and non-vascular stents (as described above) can be used in substantially the same manner.

[0077] As shown in Figure 9, the query module 24 and control unit 26 are positioned outside the patient's skin 32. The query signal 28 is a wireless RF signal that passes through the patient's skin, and the data is received on the wireless RF signal 30 from the sensor 22 and returned to the query module 24. The wireless signal may be within any frequency range, but the RF range is preferred. Frequencies in the VLF to LF range of 3 to 300 kHz are preferred in order to allow the signal to be carried to a sufficient depth in the body with low power, but frequencies below 3 kHz and frequencies above 300 kHz can also be used. Detection does not require the transfer of large amounts of data and low power is preferred, therefore low frequency RF signals are preferable. This also avoids conflict with other wireless signal generators, such as Bluetooth®, mobile phones, etc., and avoids accidental activation by such other wireless signal generators.

[0078] L. Data collection, transfer, analysis, and distribution from stents. Figure 10 shows one embodiment of an information and communication technology (ICT) system 800 configured to process sensor data (for example, data from any one sensor 22 in Figures 1, 2, 3, 4, 5, 6, or 7). In Figure 10, the ICT system 800 is shown as including computer calculations that exchange information via a network 804, but in other embodiments, computer devices may exchange information directly with each other or via other intermediary devices, and in some cases, computer devices may not exchange information at all. The computer device in Figure 10 has a computing server 802, a control unit 26, a query unit 24, and other devices that are not shown for clarity.

[0079] In Figure 10, one or more sensors 22 communicate with the query module 24. The query module 24 is directed by the control unit 26, but otherwise, it operates autonomously to transmit and receive information from the sensors 22. Either the query module 24 or the control unit 26, or both, can communicate with the computing server 802.

[0080] In certain embodiments, the query module and / or control unit may be a wearable device attached to the patient. The wearable device (e.g., a wristwatch, wristband, eyeglasses, or other device that can be carried or worn by the patient) may query sensors over a set (or random) period to collect data and send the data to one or more networks (804). Furthermore, the wearable device may spontaneously collect data that can also be sent to the network. Typical examples of collectible data include location (e.g., GPS), body temperature or skin temperature, and other physiological data (e.g., pulse rate). In yet another embodiment, the wearable device may directly notify the patient of any of many predetermined conditions, including (but not limited to) a potential or actual malfunction of the device.

[0081] The information transmitted between the inquiry module 24 and the sensor 22 can be useful for many purposes described herein. In some cases, for example, sensor data information is collected and explicitly analyzed for the health of an individual patient. In other cases, sensor data is collected and transmitted to another computer for aggregation with other data (for example, sensor data from sensor 22 is collected and aggregated with other data collected from a wearable device (for example, a device that may include GPS data in a particular embodiment)).

[0082] Figure 10 shows a view of computing server 802 as a collaborative bank of servers, further including computing servers 802a, 802b, and one or more other servers 802n. As can be understood, computing server 802 may include any number of computing servers operating individually or collectively in accordance with the interests of the users of the computing servers.

[0083] In some embodiments, the computing server 802 is configured as a cloud computing device located in one or more geographical locations, for example, within the United States and Canada. The computing device may be configured as a Microsoft Azure cloud computing device or as several other virtually accessible remote computing services.

[0084] The query module 24 and control unit 26 are optionally shown to communicate with the computing server 802. Sensor data is transferred to (and additionally or alternatively transferred from) the computing server 802 via the network 804 through the query module 24 or the control unit 26.

[0085] Network 804 includes cellular communication networks, conventional cable networks, satellite networks, optical fiber networks, and some or all of one or more local area networks, wide area networks, personal area networks, etc., configured as a computing network. In a preferred embodiment, Network 804 includes any communication hardware and software that work together to enable users of computer devices to browse and interact with other computer devices.

[0086] The computing server 802 includes a central processing unit (CPU) digital signal processing unit (DSP) 808, a communication module 810, an input / output (I / O) module 812, and a storage module 814. The components of the computing server 802 are cooperatively coupled to one another by one or more buses 816, which facilitate the transfer and control of information within and through the computing server 802. The communication module 810 can be configured to transmit information between the computing server 802 and other computing devices (e.g., computing servers 802a, 802b, 802n, control unit 26, query unit 24, etc.). The I / O module 812 can be configured to receive input from devices such as a keyboard, computer mouse, trackball, etc. The I / O module 812 can be configured to provide output to devices such as a display, recorder, LED, audio device, etc.

[0087] The memory module 814 may include one or more types of storage media. For example, the memory module 814 in Figure 10 includes a read-write memory (RAM) 818, a read-only memory (ROM) 820, a disk memory 822, an optical memory 824, and other types of memory storage media 826. In some embodiments, one or more database structures are built on one or more storage devices in the memory module 814. Using the database structure, data collected from the sensor 22 can be stored.

[0088] In some embodiments, the memory module 814 may further include one or more portions of memory organized as a non-transient computer-readable medium (CRM). The CRM is configured to store computer computation instructions that can be executed by the CPU 808. The computer computation instructions may be stored as one or more files, each file may contain one or more computer programs. The computer programs may be standalone programs or parts of larger computer programs. Alternatively or additionally, each file may contain data or other computer computation support material for an application that commands the collection, analysis, processing, and / or distribution of data from a sensor (e.g., a stent sensor). A sensor data application typically executes a set of instructions stored on the computer-readable medium.

[0089] To ensure understanding, the computing servers illustrated and described herein are illustrative and do not limit the scope of the present invention. Computing server 802 can be connected to other devices not shown, such connections include connections via one or more networks, for example, via the Internet or via the Web embedded in network 804. Generally speaking, a computer computing system or device (e.g., “client” or “server”) or any part thereof may optionally include any combination of hardware that can interact with each other to perform functions in the manner described, if programmed or otherwise configured by software, such hardware includes, but is not limited to, desktop or other types of computers, database servers, network storage devices and other network devices, PDAs (personal digital assistants), mobile phones, wireless telephones, pagers, electronic organizers, internet appliances, television-based systems (e.g., set-top boxes and / or personal / digital video recorders) and various other products including appropriate local area communication functions. Furthermore, the functions provided by the illustrated system modules may, in some embodiments, be combined into a state with fewer modules or distributed into a state with additional modules. Similarly, in some embodiments, some functions of the illustrated modules may not be provided and / or other additional functions may be available.

[0090] In addition, although various items are shown as being stored in memory or being stored while being used, it is preferable that these items or some of these items be transferred between memory and other storage devices for memory management and / or data integrity purposes. In at least some embodiments, the illustrated modules and / or systems are software modules / systems that, when executed by a CPU / DSP808 or other processor, include software instructions that program this processor to automatically perform the described operations for the module / system. In variations, in other embodiments, some or all of the software modules and / or systems may operate in memory located in another device and communicate information with the illustrated computer computing system / device via intercomputer communication.

[0091] Furthermore, in some embodiments, some or all of the modules and / or systems may be partially implemented or provided in other ways, for example, in the form of at least firmware and / or hardware means, such means including, but not limited to, one or more application-specific integrated circuits (ASICs), standard integrated circuits, controllers (e.g., by executing appropriate instructions, and including microcontrollers and embedded controllers), field-rewritable gate arrays (FPGAs), composite programmable logic devices (CPLDs), etc. Some or all of the systems, modules, or data structures may also be stored on transient or non-transient computer-readable storage media 814, such as hard disks 822 or flash drives or other non-volatile storage devices 826, volatile memory 818, non-volatile memory 820, network storage devices or portable media articles (e.g., DVD discs, CD discs, optical discs, flash memory devices, etc.) which are to be read by appropriate input or output systems or via appropriate connection schemes (e.g., as software instructions or structured data). The system, modules, and data structures are also, in some embodiments, transmitted as generated data signals (e.g., as carrier waves or other analog or digital propagation signals) over various computer-readable transmission media, such as wireless and wired / cable media. The data signals can take various forms, such as as part of a single or multiplexed analog signal, as a number of separate signal packets or frames, as separate or streaming sets of digital bits, or in any other form. Such computer program products can also take other forms in other embodiments. Therefore, the present invention can be implemented in other computer system configurations.

[0092] In Figure 10, for example, sensor data from sensor 22 is provided to computing server 802. Generally speaking, sensor data represents data extracted from known patients and known sensors. It is preferable that sensor data include or be further related to additional information, such as USI, UDI, timestamp, location (e.g., GPS), date stamp, and other information. The difference between various sensors lies in the fact that some may contain many or few data bits that associate the data with a specific source, collection device, transmission characteristics, etc.

[0093] In some embodiments, sensor data may include sensitive information requiring careful handling, such as private health information associated with a specific patient. Sensitive information, such as sensor data from sensor 22, may include any information that the parties involved wish not to be widely or easily disclosed. Sensitive information may be independent or combined with other non-sensitive information. For example, a patient's medical information is typically sensitive information. In some cases, the storage and transmission of a patient's medical information is protected by government orders (e.g., laws, regulations, etc.), such as the Health Insurance Portability and Accountability Act (HIPPA) in the United States.

[0094] When we refer to “sensitive” information as described herein, this includes information that is entirely sensitive and information that is any combination of sensitive and non-sensitive information. Sensitive information is best represented in the form of a data file or in some other format. A data file containing a patient’s medical information, as used herein, may be referred to as “sensitive information.” Other information, such as employment information, financial status, identification information, and many other forms of information, may also be considered sensitive information.

[0095] Computer systems can represent sensitive information using coding algorithms (e.g., ASCII), well-recognized file formats (e.g., PDF), or some other format. Computer systems can also protect sensitive information from widespread or easily leaked information using encryption algorithms.

[0096] Generally speaking, sensitive information can be stored by computer systems as separate sets of data bits. A set of data bits is sometimes called "plaintext." Furthermore, computer systems can utilize encryption processes and encryption algorithms (i.e., ciphers) to convert plaintext into a set of data bits that is virtually unreadable (i.e., ciphertext). A computer system with knowledge of the encryption key used to create the ciphertext can restore this information to a readable state of plaintext. Therefore, in some cases, sensitive data (e.g., sensor data 806a, 806b) is optionally encrypted before being transmitted to a computer.

[0097] In one embodiment, the operation of the information and communication technology (ICT) system 800 in Figure 10 includes one or more sensor data computer programs stored on a computer-readable medium. The computer programs can optionally derive and / or receive data from one or more stent sensors implanted in the bodies of one or more patients. It is preferable to run the sensor data computer programs within the computing server 802. Alternatively or additionally, the sensor data computer programs can run within the control unit 26 and the query unit 24.

[0098] In one embodiment, a computer program that commands the collection and use of stent sensor data is stored on a non-transient computer-readable medium in a storage module 814. The computer program is configured to identify the patient in whom the wireless stent is implanted. The wireless stent may have one or more wireless sensors.

[0099] In some cases, the computer program identifies one patient, and in other cases, two or three or more patients are identified. Each patient may have one or more wireless stents, and each wireless stent may have one or more wireless sensors of the type described herein.

[0100] The computer program is configured to command the collection of sensor data from the wireless stent device. The sensor data is generally collected by a wireless query unit 24. In some cases, the program communicates with the wireless query unit 24. In other cases, the program communicates with a control unit 26, which issues commands to the wireless query unit 24. In yet other cases, other mechanisms are used to command the collection of sensor data.

[0101] Once sensor data is collected, it is desirable to process such data further. For example, in some cases, sensor data may include sensitive patient data that can be deleted or unassociated with such data. Sensor data may be stored individually (e.g., by a unique sensor identification number, device number, etc.) or aggregated with other sensor data by sensor type, timestamp, location stamp, date stamp, patient type, other patient characteristics, or some other means.

[0102] The following pseudo-code description is executed by computing server 802 and is used as a whole to illustrate one example algorithm described herein with reference to Figure 10. JPEG2026090342000002.jpg78150

[0103] As those skilled in the art will recognize, it is customary in the art to materialize apparatus and / or processes and / or systems, and then to incorporate such materialized apparatus and / or processes and / or systems into a more comprehensive apparatus and / or processes and / or systems using technology and / or other practices. That is, at least a portion of the apparatus and / or processes and / or systems described herein can be incorporated into other apparatus and / or processes and / or systems by a reasonable amount of experimentation. As will be recognized by those skilled in the art, examples of such other devices and / or processes and / or systems may include, where appropriate to the context and use, all or part of: (a) air transport (e.g., airplanes, rockets, helicopters); (b) ground transport (e.g., automobiles, trucks, locomotives, tanks, armored personnel carriers); (c) buildings (e.g., houses, warehouses, offices); (d) electrical appliances (e.g., coffee makers, refrigerators, washing machines, dryers); (e.g., communication systems (e.g., networking systems, telephone systems, Voice over IP systems); (f) enterprises (e.g., Internet service provider (ISP) enterprises, e.g., Comcast Cable, Qwest, Southwestern Bell); or (g) wired / wireless service providers (e.g., AT&T, T-Mobile, Verizon).

[0104] In certain cases, the use of a system or method may occur within a jurisdiction even if its components are located outside that jurisdiction. For example, in a distributed computing context, the use of a distributed computing system may occur within a jurisdiction even if parts of the system (e.g., relays, servers, processors, signal carriers, transmitting computers, receiving computers, etc., located outside that jurisdiction) are located outside that jurisdiction. In one embodiment of the present invention, the patient with the stent may be in one location, while the data processing and analysis are performed in another location.

[0105] The sale of a system or method may also occur within a jurisdiction, even if components of the system or method are located outside the jurisdiction and / or used outside the jurisdiction. Furthermore, the embodiment of at least a portion of a system that implements a method within one jurisdiction does not preclude the use of the system within another jurisdiction.

[0106] In conclusion, stents utilizing various sensors can be used to assist in various important clinical functions, such as safe, accurate, and minimally traumatic placement and deployment of the stent, procedural and postoperative "real-time" imaging of the stent and its surrounding anatomical structures, the occurrence of stent complications, and the overall health status of the patient (cardiac, renal, and other physiological parameters). Currently, postoperative evaluation of patients who have undergone stent replacement (both inpatients and outpatients) relies on medical monitoring (vital signs, blood studies, ECG, etc.) supplemented with patient history, anthropometric measurements, and diagnostic imaging studies as needed. However, much of the patient's recovery period occurs between hospital visits and clinic visits, and much of the data on daily function remains uncaptured. Furthermore, monitoring the patient's progress using any diagnostic imaging technique can be costly and invasive, and may also carry its own health risks (e.g., coronary angiography). Therefore, accurately measuring and following the onset or worsening of symptoms and evaluating "real-world" stent performance is extremely difficult. This is because the symptoms are particularly related to the patient's activity level, exercise tolerance, and the effectiveness of rehabilitation efforts and medications.

[0107] Currently, neither physicians nor patients have access to a form of "real-time," continuous, objective stent performance measurement that they might otherwise wish they had. Monitoring the stent's function, integrity, anatomical structure, and physiological characteristics in situ would provide physicians with useful objective information during clinic visits, and patients could obtain additional readings at home at various points in time (e.g., when experiencing pain, during exercise, after taking medication) to provide physicians with important complementary clinical information (which could be sent electronically to healthcare providers, even remotely). From a patient's perspective, being able to monitor many of these same parameters at home allows them to play a more preventative role in patient care and recovery, and can provide patients with either early warning indicators or assurances for seeking medical assistance.

[0108] In one variation, the patient may also have such a reader at home, which periodically verifies data from the stent, for example, once a day or once a week. In addition to empowering patients to continue their own rehabilitation—and enabling them to recognize the positive (and negative) effects of various lifestyle choices on their health and rehabilitation—such information access can be expected to improve compliance and enhance patient outcomes. For example, in certain embodiments, the devices and systems provided herein can instruct or otherwise notify the patient or an authorized third party of deviations from normal and / or set parameters (e.g., greater than 10%, greater than 20%, greater than 25%, greater than 50%, greater than 70%, and / or greater than 100%). Furthermore, patients can share their recovery experiences with other patients via the web, thereby drawing their attention to signs and symptoms that should attract the patient's physician's attention by comparing their progress to expected "standards" regarding function and rehabilitation (e.g., on Facebook® or other social media sites). From a public health perspective, comparing the performance of different stents across different patients (different sexes, disease severity, activity levels, comorbidities, e.g., hypertension, diabetes, smoking status, obesity, etc.) helps manufacturers design better stents and physicians select the appropriate stent for specific patient types. Payers, patients, manufacturers, and physicians all benefit from the collection of this comparative information. Substandard and dangerous products can be identified and removed from the market, and objective, long-term valid data can be collected and analyzed. Finally, data collected at home can be sent to physicians' clinics via the internet for analysis—potentially eliminating unnecessary visits and facilitating faster medical follow-up.

[0109] The following are some specific numbered embodiments of the systems and methods disclosed herein. These embodiments are illustrative only. To be understood, the present invention is not limited to the embodiments described herein for illustrative purposes, but includes all such forms of the present invention that fall within the scope of the above disclosure. [Implementation Item 1] An assembly comprising a stent and a sensor disposed on or inside the stent. [Implementation Section 2] The above sensor is an assembly according to Embodiment 1, which is positioned on the outer wall of the stent. [Embodiment 3] The above sensor is an assembly according to embodiment 1, which is positioned on the inner wall of the above stent. [Embodiment Item 4] The above sensor is an assembly according to Embodiment 1, which is located inside the above stent. [Embodiment 5] The assembly according to Embodiment 1, wherein the sensor is positioned on the surface of the lumen, on the para-lumen surface, and / or implanted within the lumen. [Implementation Section 6] The above-mentioned sensor is a fluid pressure sensor, as described in any one of Embodiments 1 to 4. [Embodiment 7] The above sensor is a contact sensor, as described in any one of Embodiments 1 to 4. [Embodiment 8] The above sensor is a position sensor, as described in any one of Embodiments 1 to 4. [Embodiment Item 9] The above sensor is a pulse pressure sensor, as described in any one of Embodiments 1 to 4. [Implementation item 10] The above-mentioned sensor is a blood volume sensor, as described in any one of Embodiments 1 to 4. [Initiative 11] The above sensor is a blood flow sensor, as described in any one of Embodiments 1 to 4. [Implementation item 12] The above-mentioned sensor is a blood chemistry sensor, as described in any one of Embodiments 1 to 4. [Embodiment 13] The above-mentioned sensor is a blood metabolism sensor, as described in any one of Embodiments 1 to 4. [Embodiment Item 14] The above-mentioned sensor is a mechanical stress sensor, an accelerometer, or a temperature sensor, as described in any one of Embodiments 1 to 4. [Embodiment Item 15] The assembly according to any one of embodiments 1 to 14, wherein the stent is a vascular stent, a digestive stent, a lung stent, a head and neck stent, or a genitourinary stent. [Implementation Item 16] The assembly according to Embodiment 15, wherein the vascular stent is a coronary artery stent, a carotid artery stent, a cerebral stent, a vertebral stent, an iliac stent, a femoral stent, a popliteal stent, or a stent for the arteries of the lower limbs. [Embodiment Item 17] The assembly according to Embodiment 15, wherein the digestive stent is an esophageal stent, a duodenal stent, a colonic stent, a gallbladder stent, or a pancreatic stent. [Embodiment 18] The above-mentioned lung stent is a stent that maintains the trachea, bronchi, bronchioles, or alveoli in a patency state, as described in Embodiment 15. [Implementation item 19] The assembly according to Embodiment 15, wherein the urogenital stent is a ureteral stent, a urethral stent, a urethral prostatic stent, or a fallopian tube stent. [Embodiment 20] The assembly according to Embodiment 15, wherein the head and neck stent is a sinus stent, maxillary sinus stent, frontal sinus stent, lacrimal duct stent, nasal stent, or middle ear ventilation tube. [Implementation Clause 21] The above-mentioned stent is a biodegradable or partially biodegradable stent, as described in any one of Embodiments 1 to 20. [Embodiment Section 22] The above-mentioned stent is a non-biodegradable stent, as described in any one of Embodiments 1 to 20. [Embodiment 23] The above-mentioned sensor is a wireless sensor, as described in any one of Embodiments 1 to 22. [Embodiment Section 24] The above sensor is an assembly according to any one of embodiments 1 to 22, connected to a wireless microprocessor. [Embodiment 25] The assembly according to any one of embodiments 1 to 24, wherein multiple sensors are arranged on or inside the stent. [Embodiment Clause 26] The above-mentioned stent is an assembly according to any one of embodiments 1 to 25, having two or more types of sensors. [Embodiment Clause 27] The above-mentioned stent is an assembly according to any one of embodiments 1 to 26, having one or more fluid pressure sensors, contact sensors, accelerometers, and position sensors. [Embodiment 28] The assembly according to any one of embodiments 1 to 27, wherein the sensors are a plurality of sensors arranged on or inside the stent at a sensor density of one or more, two or more, three or more, four or more, five or more, six or more, seven or more, eight or more, nine or more, ten or more, or twenty or more per square centimeter. [Embodiment Section 29] The assembly according to any one of embodiments 1 to 27, wherein the sensors are a plurality of sensors arranged on or inside the stent at a sensor density of one or more, two or more, three or more, four or more, five or more, six or more, seven or more, eight or more, nine or more, ten or more, or twenty or more per cubic centimeter. [Embodiment 30] The above sensor is an assembly according to any one of Embodiments 1 to 29, having a unique sensor identification number. [Embodiment 31] The above-mentioned sensor is uniquely located within a specified position on or inside the above-mentioned stent, as described in any one of the embodiments 1 to 30. [Embodiment 32] The above-mentioned stent is an assembly according to any one of the embodiments described in sections 1 to 31, comprising two or more sections. [Embodiment 33] The above-mentioned sensors are arranged on each of the two or more sections described above in the assembly according to embodiment 32. [Embodiment 34] The above sensor can be used to detect the proper connection or assembly of a complete stent, as described in Embodiment 32. [Embodiment 35] An assembly comprising a stent and a sensor, wherein the sensor measures the cardiac output of a patient. [Embodiment 36] An assembly comprising a stent and a sensor, wherein the sensor measures the stroke volume of a patient. [Embodiment 37] An assembly comprising a stent and a sensor, wherein the sensor measures the ejection fraction of a patient. [Embodiment 38] An assembly comprising a stent and a sensor, wherein the sensor measures the patient's systolic blood pressure. [Embodiment 39] An assembly comprising a stent and a sensor, wherein the sensor measures the patient's diastolic blood pressure. [Embodiment Item 40] An assembly comprising a stent and a sensor, wherein the sensor measures the mean arterial pressure of a patient. [Embodiment Item 41] An assembly comprising a stent and a sensor, wherein the sensor measures the systemic vascular resistance of a patient. [Embodiment Section 42] An assembly comprising a stent and a sensor, wherein the sensor measures the total peripheral resistance of a patient. [Embodiment Item 43] An assembly comprising a stent and a sensor, wherein the sensor measures the patient's body temperature. [Embodiment Item 44] An assembly comprising a stent and a sensor, wherein the sensor measures the occurrence of restenosis. [Embodiment Item 45] An assembly comprising a stent and a sensor, wherein the sensor measures cardiac function. [Embodiment Item 46] An assembly comprising a stent and a sensor, wherein the sensor measures the occurrence of thrombosis, atherosclerosis, tumor, inflammation, abscess, or other space-occupying lesions. [Embodiment Item 47] An assembly comprising a stent and a sensor, wherein the sensor measures the development of normal healing tissue on the luminal surface of the stent.

[0110] [Embodiment 48] An assembly comprising a stent and a sensor, wherein the sensor measures metabolic function, including indicators of renal function. [Embodiment Item 49] An assembly comprising a stent and a sensor, wherein the sensor measures cardiac rhythm including conduction and rhythmic abnormalities. [Embodiment 50] The above-mentioned stent is a drug-eluting stent, as described in any one of Embodiments 1 to 49. [Embodiment 51] The above-mentioned stent is at least partially coated with one or more polymers, as an assembly according to any one of embodiments 1 to 50. [Embodiment 52] Use of a stent or assembly described in any one of Embodiments 1 to 51, for the purpose of obtaining measurements of cardiac function. [Embodiment 53] The above-mentioned measurements of cardiac function are selected from the group consisting of cardiac output, stroke volume, ejection fraction, systolic and / or diastolic blood pressure, mean arterial pressure, systemic vascular resistance, and total peripheral resistance, as described in Embodiment 52. [Embodiment 54] The above measurements are performed at two or more points in time, as described in Embodiment section 52 or 53. [Embodiment 55] The above measurements are performed over a period of one or more days, two or more days, three or more days, four or more days, five or more days, ten or more days, fifteen or more days, or thirty or more days, as described in any one of the embodiments described in 52 to 54. [Embodiment 56] The above measurements are performed over a period of one month or more, two months or more, three months or more, four months or more, five months or more, six months or more, or twelve months or more, as described in any one of the Embodiments 52 to 55. [Embodiment 57] A method for monitoring stents, The steps include: transmitting a wireless electrical signal from an external location to an internal location within the human body; and receiving the signal at a sensor located on a stent provided inside the human body. The steps include supplying power to the sensor using the received signal, The above step involves detecting data at the sensor, A method comprising the step of outputting the detected data from the sensor to a receiving unit located outside the human body. [Embodiment 58] The method according to Embodiment 57, wherein the stent is an assembly described in any one of Embodiments 1 to 51. [Embodiment 59] The method according to the embodiment described in section 57 or 58, wherein the receiving unit is a wristwatch, a wristband, a mobile phone, or eyeglasses. [Embodiment 60] The above-mentioned receiving unit is installed in the patient's residence or clinic, according to any one of embodiments 57 to 59. [Implementation clause 61] The above-mentioned detected data is provided to healthcare providers according to the method of any one of the embodiments described in items 57 to 60. [Embodiment Clause 62] The above-detected data is written to one or more websites, according to the method of any one of Embodiments 57 to 61. [Embodiment 63] A non-transient computer-readable storage medium that configures a computer computing system for storage content to perform a method, wherein the method is The process includes the step of identifying a patient, wherein the identified patient has at least one wireless stent, and each wireless stent has one or more wireless sensors. The process includes the step of instructing a wireless inquiry unit to collect sensor data from at least one of the one or two or more wireless sensors described above, A non-transient, computer-readable storage medium, including the step of receiving the sensor data collected above. [Embodiment Item 64] A non-transient computer-readable storage medium that configures a computer computing system for storage content to perform a method, wherein the method is The process further includes the step of identifying multiple patients, each identified patient having at least one wireless stent, and each wireless stent having one or more wireless sensors. The steps include instructing a wireless inquiry unit associated with each identified patient to collect sensor data from at least one of the one or more wireless sensors described above, This includes the step of receiving the sensor data collected above, A non-transient computer-readable storage medium according to claim 63, comprising the step of aggregating the sensor data collected above. [Embodiment 65] The above method, The above steps include removing sensitive patient data from the collected sensor data, A non-transient computer-readable storage medium according to Embodiment 63, further comprising the step of parsing the collected data according to the type of sensor, and configuring a computer computing system to enable the storage content to perform the method. [Implementation clause 66] The non-transient computer-readable storage medium according to Embodiment 63, wherein the step of instructing the wireless query unit includes a step of instructing a control unit associated with the wireless query unit to configure the computer computing system so that the storage content performs the method. [Embodiment 67] The above-mentioned stent is an assembly according to any one of Embodiments 1 to 51, and the non-transient computer-readable storage medium according to any one of Embodiments 63 to 66. [Embodiment 68] The collected sensor data is received on a non-transient computer-readable storage medium according to any one of embodiments 63 to 67, on a wristwatch, wristband, mobile phone, or eyeglasses. [Embodiment Item 69] The collected sensor data is received in the patient's residence or office on a non-transient computer-readable storage medium according to any one of embodiments 63 to 68. [Embodiment Clause 70] The collected sensor data is provided to a healthcare provider in a non-transient, computer-readable storage medium according to any one of embodiments 63 to 69. [Embodiment Clause 71] The collected sensor data is written to one or more websites on a non-transient computer-readable storage medium according to any one of embodiments 63 to 70. [Embodiment 72] A storage medium according to the method of any one of Embodiments 57 to 62 or any one of Embodiments 63 to 71, wherein the above data is analyzed. [Embodiment Item 73] The above data is plotted in a manner that allows for the visualization of changes over time, as described in Embodiment 72 of the method or storage medium. [Embodiment Clause 74] The above data is plotted to provide a three-dimensional image, in the method or storage medium according to Embodiment 72 or 73. [Embodiment Item 75] A method for determining stent deterioration, comprising: a) providing an assembly including a stent and one or more sensors to a patient's internal passage; and b) detecting a change in the sensors to thus determine the deterioration of the stent. [Embodiment 76] The method according to embodiment 75, wherein the sensor can detect one or more physiological and / or spatial parameters. [Embodiment Clause 77] The above-mentioned sensor is a method according to embodiment 75 or 76 for detecting contact, fluid flow rate, pressure and / or temperature. [Embodiment 78] The above sensor is a method according to any one of embodiments 75 to 77, which detects the location inside the patient's body. [Embodiment Clause 79] The above assembly is the assembly described in any one of Embodiments 1 to 51, according to the method according to any one of Embodiments 75 to 78. [Embodiment 80] The above detection step is a series of detections over time, according to any one of Embodiments 75 to 79. [Embodiment 81] A method for imaging a stent, comprising the step of detecting changes over time of sensors inside, on, and / or inside the stent, wherein the stent has sensors at a sensor density of 1 or more, 2 or more, 3 or more, 4 or more, 5 or more, 6 or more, 7 or more, 8 or more, 9 or more, 10 or more, or 20 or more per square centimeter. [Embodiment 82] A method for imaging a stent, comprising the step of detecting changes over time of sensors inside, on, and / or inside the stent, wherein the stent has sensors at a sensor density of 1 or more, 2 or more, 3 or more, 4 or more, 5 or more, 6 or more, 7 or more, 8 or more, 9 or more, 10 or more, or 20 or more per cubic centimeter. [Embodiment 83] The method according to embodiment 81 or 82, wherein the sensor is one or more of the following: a fluid pressure sensor, a contact sensor, a position sensor, an accelerometer, a pulse pressure sensor, a blood volume sensor, a blood flow sensor, a blood chemistry sensor, a blood metabolism sensor, a mechanical stress sensor, and a temperature sensor. [Embodiment 84] The method according to any one of embodiments 81 to 83, wherein the stent described above is an assembly described in any one of embodiments 1 to 51. [Embodiment 85] A method for a patient to place a stent in the body, comprising the steps of: a) implanting an assembly described in any one of Embodiments 1 to 51; and b) detecting the placement of the stent by detecting a sensor. [Embodiment 86] The method according to Embodiment 85, wherein the stent has two or more sections, and the detection of the two or more sections can be determined by analysis of one or more sensors. [Embodiment 87] The arrangement of the stent can be visualized by a two-dimensional or three-dimensional display or by images of one or more sensors on the stent, as described in Embodiment 85 or 86. [Embodiment 88] The above stent comprises two stents implanted so as to overlap each other, according to any one of embodiments 85 to 87. [Embodiment Item 89] The method according to any one of embodiments 85 to 88, wherein the above detection of the stent's arrangement makes it possible to determine whether the stent is twisted or incorrectly positioned.

[0111] Any combination of the various embodiments described above can be used to provide other embodiments. All U.S. patents, U.S. patent application publications, U.S. patent applications, PCT application publications, foreign patents, foreign patent applications, and non-patent literature referenced herein are incorporated herein by reference and their entire contents constitute part of this specification. Further embodiments can be provided by modifying the aspects of the embodiments as necessary to adopt the concepts of various patents, patent applications, and patent application publications. These and other modifications can be made to the embodiments in light of the contents of the detailed description above. In general, the terms used in the following claims should not be interpreted as limiting the invention described in the claims to this specification and any specific embodiments disclosed herein, but rather as encompassing all conceivable embodiments together with the entire scope of equivalents based on the claims. Thus, the invention described in the claims is not limited by the contents of the specification.

Claims

1. A non-transient computer-readable storage medium that configures a computer computing system for storage content to perform a method, The process includes the step of identifying a patient, wherein the identified patient has at least one wireless stent, and each wireless stent has one or more wireless sensors. The process includes the step of instructing a wireless inquiry unit to collect sensor data from at least one of the one or more wireless sensors, A non-transient computer-readable storage medium, including the step of receiving the aforementioned collected sensor data.

2. A non-transient computer-readable storage medium that configures a computer computing system for storage content to perform a method, wherein the method is The process further includes the step of identifying multiple patients, each identified patient having at least one wireless stent, and each wireless stent having one or more wireless sensors. The steps include instructing a wireless inquiry unit associated with each identified patient to collect sensor data from at least one of the one or more wireless sensors, The step includes receiving the aforementioned collected sensor data, A non-transient computer-readable storage medium according to claim 1, comprising the step of aggregating the aforementioned collected sensor data.

3. The aforementioned method, The steps include removing sensitive patient data from the collected sensor data, A non-transient computer-readable storage medium according to claim 1, further comprising the step of parsing the collected data according to the type of sensor, and configuring a computer computing system so that the storage content performs the method.

4. The non-transient computer-readable storage medium according to claim 1, wherein the step of instructing the wireless query unit includes a step of instructing a control unit associated with the wireless query unit to configure a computer computing system so that the storage content performs the method.

5. The non-transient computer-readable storage medium according to claim 1, wherein the stent is an assembly comprising a single stent and a sensor disposed on or inside the single stent.

6. The non-transient computer-readable storage medium according to claim 5, wherein the sensor is positioned on the outer wall of the stent, on the inner wall of the stent, inside the stent, on the lumen surface of the stent, on the paralumen surface of the stent, and / or implanted in the lumen of the stent.

7. The non-transient computer-readable storage medium according to claim 5, wherein the sensor is selected from a fluid pressure sensor, a contact sensor, a position sensor, a pulse pressure sensor, a blood volume sensor, a blood flow sensor, a blood chemistry sensor, a blood metabolism sensor, a mechanical stress sensor, an accelerometer, and a temperature sensor.

8. The stent is selected from vascular stents, digestive stents, lung stents, head and neck stents, and urogenital stents. The vascular stents mentioned above are selected from coronary artery stents, carotid artery stents, cerebral stents, vertebral stents, iliac stents, femoral stents, popliteal stents, and stents for the arteries of the lower extremities. The digestive stents mentioned above are esophageal stents, duodenal stents, colonic stents, gallbladder stents, or pancreatic stents. The lung stent is a stent that maintains the trachea, bronchi, bronchioles, or alveoli in a patency state. The urogenital stents mentioned above are ureteral stents, urethral stents, urethral prostatic stents, or fallopian tube stents. The non-transient computer-readable storage medium according to claim 5, wherein the head and neck stent is a sinus stent, maxillary sinus stent, frontal sinus stent, lacrimal duct stent, nasal stent, or middle ear ventilation tube.

9. The stent is a biodegradable or partially biodegradable stent, The aforementioned stent is a non-biodegradable stent. The aforementioned sensor is a wireless sensor. The sensor is connected to a wireless microprocessor. Multiple sensors are arranged on or inside the stent. The stent has two or more types of sensors, The stent is a drug-eluting stent, or The non-transient computer-readable storage medium according to claim 5, wherein the stent is at least partially coated with one or more polymers.

10. The non-transient computer-readable storage medium according to claim 5, wherein the sensors are a plurality of sensors, and the sensors are arranged on or inside the stent at a sensor density of one or more, two or more, three or more, four or more, five or more, six or more, seven or more, eight or more, nine or more, ten or more, or twenty or more per square centimeter, and / or arranged on or inside the stent at a sensor density of one or more, two or more, three or more, four or more, five or more, six or more, seven or more, eight or more, nine or more, ten or more, or twenty or more per cubic centimeter.

11. The non-transient computer-readable storage medium according to claim 5, wherein the sensor has a unique sensor identification number and / or is uniquely located within a designated position on or inside the stent.

12. The non-transient computer-readable storage medium according to claim 5, wherein the stent is composed of two or more sections, the sensors are positioned on each of the two or more sections, and / or the sensors can be used to detect the proper connection or assembly of the complete stent.

13. The non-transient computer-readable storage medium according to claim 5, wherein the sensor measures the patient's cardiac output, the sensor measures the patient's stroke volume, the sensor measures the patient's ejection fraction, the sensor measures the patient's systolic blood pressure, the sensor measures the patient's diastolic blood pressure, the sensor measures the patient's mean arterial pressure, the sensor measures the patient's systemic vascular resistance, the sensor measures the patient's total peripheral resistance, the sensor measures the patient's body temperature, the sensor measures the occurrence of restenosis, the sensor measures cardiac function, the sensor measures thrombus formation, the sensor measures the progression of atherosclerosis, the sensor measures tumor formation, the sensor measures the progression of inflammation, and the sensor measures the occurrence of an abscess or other space-occupying lesion.

14. The collected sensor data is received on a wristwatch, wristband, mobile phone, or eyeglasses, in a non-transient computer-readable storage medium according to any one of claims 1 to 13.

15. The collected sensor data is received in the patient's residence or office, in a non-transient computer-readable storage medium according to any one of claims 1 to 14.

16. The collected sensor data is provided to a healthcare provider in a non-transient computer-readable storage medium according to any one of claims 1 to 15.

17. The collected sensor data is written to one or more websites on a non-transient computer-readable storage medium according to any one of claims 1 to 16.

18. A non-transient computer-readable storage medium according to any one of claims 1 to 17, wherein the collected sensor data is analyzed.

19. The non-transient computer-readable storage medium according to claim 18, wherein the collected sensor data is plotted to enable visualization of changes over time.

20. The non-transient computer-readable storage medium according to claim 18, wherein the collected sensor data is plotted to provide a three-dimensional image.

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