Provide a medical device with sensing function

Abstract

Ancillary components for medical devices, and more specifically, sensing constructs that can be added to medical devices such as implantable medical devices to provide a medical device with sensing capabilities. The ancillary components are not part of the medical device but are associated with the existing medical device in a safe manner and provide information about the medical device and / or the environment surrounding the medical device when the device is implanted in a patient, and then transmit that information to a location outside the patient for evaluation.

Description

[0001] Cross - reference to related applications

[0002] This application claims the benefit of U.S. Provisional Patent Application No. 62 / 828,579, filed on April 3, 2019, under 35 U.S.C.§119(e), which is hereby incorporated by reference in its entirety for all purposes. Technical field

[0003] This application generally relates to accessory components for medical devices, and more particularly, the present invention relates to a sensing construct that can be added to a medical device such as an implantable medical device to provide a medical device with sensing capabilities. Background art

[0004] The treatment of people with injured or degenerative conditions may often involve implanting medical devices. For example, some people develop life - threatening aneurysms and are treated by implanting an endovascular graft or an endovascular stent - graft in the region of the aneurysm sac. Typically, an aneurysm is a bulge and weakness in the aortic wall, but they can occur anywhere in the human arterial vascular system. This dilation causes the aortic diameter to widen, creating what is known as an aneurysm sac. Most aortic aneurysms occur in the abdominal aorta (abdominal aortic aneurysm or AAA), but they can also occur in the thoracic aorta (thoracic aortic aneurysm or TAA) or in both the thoracic and abdominal segments of the aorta. Other examples of aneurysms include femoral aneurysms, which are bulges and weaknesses in the femoral artery wall (located in the thigh), iliac aneurysms, which are weaknesses in the iliac artery wall (a group of arteries located in the pelvis), popliteal aneurysms, which occur when there is a weakness in the popliteal artery wall that supplies blood to the knee, thigh, and calf, subclavian aneurysms, which occur at a weakness or bulge in the subclavian artery wall (located below the collarbone), suprarenal aneurysms of the aorta above the kidneys, and visceral aneurysms that occur within the celiac artery and include the celiac artery, superior mesenteric artery, inferior mesenteric artery, hepatic artery, splenic artery, and renal artery.

[0005] An endovascular graft or an endovascular stent - graft is a tubular structure that is inserted above and below the aneurysm sac and thus extends through the aneurysm sac. The graft or stent - graft captures the blood that would normally flow into the aneurysm sac and retains that blood within the graft or stent - graft. As a result, the pressure on the blood vessel wall surrounding the aneurysm sac is reduced. In turn, this reduced pressure decreases the likelihood of rupture of the wall surrounding the aneurysm sac.

[0006] Unfortunately, treating physicians do not have an easy way to fully monitor traditional grafts or traditional stent - grafts after they are implanted in a patient, nor do they have an easy way to fully monitor the area around the implanted device, such as monitoring the integrity of the aneurysm sac. This disclosure addresses that need. Summary of the Invention

[0008] Briefly, the present disclosure provides a sensing device that can be combined with a medical device such as a medical implant. The sensing device is designed to be conveniently combined with the medical device in such a way that the sensing device does not interfere with the operation of the medical device. The sensing device does not serve as a medical device, but rather supplements the benefits that the patient receives from the medical device. For example, if the medical device is a stent, in one embodiment, the sensing device can be used to monitor the operation of the stent. In another embodiment, the sensing device can be used to monitor the physical condition of the patient into whom the stent has been inserted. Thus, the sensing device itself does not provide any therapeutic value. However, when combined with the medical device, the combination of the sensing device and the medical device can provide the physiological function of the medical device as well as temporal information regarding one or both of the patient and the medical device.

[0009] In one aspect, the present disclosure provides a sensing attachment for a medical device. In one embodiment, the medical device is an implantable medical device and the sensing attachment is also implantable in a human patient. For example, it can have a size that can be delivered to the patient via a percutaneous procedure such as for delivering a stent graft. In one embodiment, the sensing attachment is intended to be physically associated with, i.e., in contact with, a medical device such as an implantable stent graft or an implantable graft (where the term implantable graft refers to a graft that does not include a stent), rather than being a medical device that itself provides the benefits of a stent or a stent graft or a graft. Thus, it can be said that the sensing attachment is not a stent, or a stent graft, or a graft. In one embodiment, the sensing attachment may not provide any therapeutic benefit to the patient other than obtaining information about the relevant medical device that is intended to provide a therapeutic benefit to the patient and communicating with third-party information derived from sensors that are part of the sensing attachment. The sensing attachment is intended to be associated with a medical device, where the medical device itself may or may not have a sensor, but in one embodiment, the present disclosure provides a sensing attachment associated with a medical device where the medical device does not include a sensor.

[0010] The sensing attachment has sensors that allow it to obtain information, and the sensing attachment also has a body, where in one embodiment, the body is adapted to be reversibly attached to and detached from the medical device. For example, when the medical device is a stent graft or a graft, the body can be reversibly adapted to fit around the outside of the graft or the stent graft, or the body can be reversibly adapted to fit around the graft or the stent graft, i.e., the sensing attachment can be attached to and detached from the graft or the stent graft. In one embodiment, the sensor is directly attached to the body. In one embodiment, the sensor is not directly attached to the body, but rather is indirectly attached to the body, for example, via a wire that extends between the body and the sensor or a housing that contains the sensor.

[0011] In one embodiment, the sensing attachment has an elastic or superelastic body. For example, the body can be made of an elastic polymer or a superelastic metal alloy such as nitinol. By being elastic or superelastic, the body can expand to fit around the outside of a medical device and then release from its expanded size to subsequently adhere closely to the outer surface of the medical device. By being elastic or superelastic, the body can be compressed to fit inside the medical device and then release from its compressed size to subsequently adhere closely to the inner surface of the medical device. In this way, the body can adopt a shape that fits around a tubular medical device such as a graft or a stent graft.

[0012] In one embodiment, the sensing attachment has a body in the shape of a spring. The body in the shape of a spring can fit inside or outside a graft or a stent graft and be held in a position relative to the surface of the medical device by means of hoop stress.

[0013] In one embodiment, the body is an adjustable-size body that can conform to the size and shape of the medical device associated therewith. To be adjustable in size, the body can be formed of an elastic material such as an elastic polymer or a superelastic metal alloy such as nitinol. Additionally, or alternatively, to be adjustable in size, the body can have a form and shape suitable for size adjustment, such as a spring or a clip.

[0014] Thus, in one aspect, the present disclosure provides a sensing attachment for a medical device, wherein the attachment includes a sensor, a body, and a communication interface configured to provide in vivo communication to another device. The body can be further described as providing one or more of the following: the body is adapted to reversibly attach to and detach from the medical device; the body is an elastic or superelastic body having a shape that conforms around the inner or outer surface of a tubular medical device such as a graft or a stent graft; the body is made of nitinol and is in the shape of a spring; the body is adjustable in size such that it can conform to the size and shape of the medical device associated therewith. The body can also be referred to as a stent because it provides a support or structure to which the sensor can be attached or fixed and also provides a structure that can hold the sensing attachment associated with the medical device.

[0015] The present disclosure provides a sensing attachment that includes a sensor, a communication interface, and a body.

[0016] For example, the present disclosure provides the following numbered exemplary embodiments of the sensing attachment:

[0017] 1. A sensing attachment for a medical device, the attachment comprising:

[0018] a) A sensor;

[0019] b) A communication interface configured to provide in - vivo communication to another device; and at least one of the following:

[0020] 1. A body adapted to be reversibly attached to and detached from a medical device.

[0021] 2. An elastic or super - elastic body having a shape that conforms around a tubular medical device such as a graft or a stent - graft.

[0022] 3. A body in the shape of a spring formed from nitinol; and / or

[0023] 4. An adjustable - size body that can conform to the size and shape of a medical device.

[0024] 2. A sensing attachment for a medical device, the attachment comprising:

[0025] a) A sensor;

[0026] b) A body adapted to be reversibly attached to and detached from a medical device; and

[0027] c) A communication interface configured to provide in - vivo communication to another device.

[0028] 3. A sensing attachment for a medical device, the attachment comprising:

[0029] a) A sensor;

[0030] b) An elastic or super - elastic body having a shape that conforms around a tubular medical device such as a graft or a stent - graft; and

[0031] c) A communication interface configured to provide in - vivo communication to another device.

[0032] 4. A sensing attachment for a medical device, the attachment comprising:

[0033] a) A body in the shape of a spring formed from nitinol;

[0034] b) A sensor attached to the body; and

[0035] c) A communication interface configured to provide in - vivo communication to another device.

[0036] 5. A sensing attachment for a medical device, the attachment comprising:

[0037] a) A sensor;

[0038] b) An adjustable - size body that can conform to the size and shape of a medical device; and

[0039] c) A communication interface configured to provide in - vivo communication to another device.

[0040] In one aspect, the present disclosure provides a sensing attachment for a medical device associated with a medical device, where the medical device associated with the sensing attachment may be referred to as a system. In one aspect, the present disclosure provides a sensing attachment for a medical device associated with a medical device, where the medical device combined with but not associated with the sensing attachment may be referred to as a kit. After receiving the kit, one can associate the included sensing attachment with the included medical device to provide the system of the present disclosure. The medical device may be a stent graft or a graft, where a graft is a medical device that does not include a stent as part of its structure, as opposed to a stent graft that has both a stent and a graft as part of its structure. The sensing attachment may not provide any therapeutic benefit to the patient other than obtaining information about the relevant medical device intended to provide a therapeutic benefit to the patient and communicating with third-party information from sensors present as part of the sensing attachment. The kit and the system include a sensing attachment and a medical device, where the medical device itself may or may not have a sensor, but in one embodiment, the present disclosure provides a kit or system that includes a sensing attachment and a medical device associated with or potentially associated with the sensing attachment, where the medical device does not include a sensor.

[0041] For example, the present disclosure provides the following numbered exemplary embodiments of kits and systems that include a sensing attachment and a medical device:

[0042] 6. A system comprising a sensing attachment for a medical device and a medical device associated with the sensing attachment, the system comprising:

[0043] a) A sensing attachment comprising:

[0044] 1. A sensor;

[0045] 2. A communication interface configured to provide in vivo communication to another device; and at least one of the following:

[0046] i. A body adapted to reversibly attach to and detach from a medical device;

[0047] ii. An elastic or superelastic body having a shape that conforms around a tubular medical device such as a graft or a stent graft;

[0048] iii. A body in the shape of a spring formed from nitinol; and / or

[0049] iv. An adjustable-sized body that can conform to the size and shape of a medical device; and

[0050] b) A medical device selected from a graft and a stent graft.

[0051] 7. A system comprising a sensing attachment for a medical device and a medical device associated with the sensing attachment, the system comprising:

[0052] a) a sensing attachment comprising:

[0053] 1. a sensor;

[0054] 2. a body adapted to reversibly attach to and detach from a medical device; and

[0055] 3. a communication interface configured to provide in vivo communication to another device; and

[0056] b) a medical device selected from a graft and a stent graft.

[0057] 8. A system comprising a sensing attachment for a medical device and a medical device associated with the sensing attachment, the system comprising:

[0058] a) a sensing attachment comprising:

[0059] 1. a sensor;

[0060] 2. an elastic or superelastic body having a shape conforming around a tubular medical device such as a graft or a stent graft; and

[0061] 3. a communication interface configured to provide in vivo communication to another device; and

[0062] b) a medical device selected from a graft and a stent graft.

[0063] 9. A system comprising a sensing attachment for a medical device and a medical device associated with the sensing attachment, the system comprising:

[0064] a) a sensing attachment comprising:

[0065] 1. a body in the shape of a spring formed of nitinol;

[0066] 2. a sensor attached to the body; and

[0067] 3. a communication interface configured to provide in vivo communication to another device; and

[0068] b) a medical device selected from a graft and a stent graft.

[0069] 10. A system comprising a sensing attachment for a medical device and a medical device associated with the sensing attachment, the system comprising:

[0070] a) a sensing attachment comprising:

[0071] 1. a sensor;

[0072] 2. An adjustable-sized body that can conform to the size and shape of a medical device; and

[0073] 3. A communication interface configured to provide in-vivo communication to another device; and

[0074] b) A medical device selected from a graft and a stent graft.

[0075] 11. A kit comprising a sensing attachment configured for a medical device and a medical device that may be associated with the sensing attachment, the kit comprising:

[0076] a) The sensing attachment, comprising:

[0077] 1. A sensor;

[0078] 2. A communication interface configured to provide in-vivo communication to another device; and at least one of the following:

[0079] i. A body adapted to reversibly attach to and detach from a medical device;

[0080] ii. An elastic or super-elastic body having a shape that conforms around a tubular medical device such as a graft or a stent graft;

[0081] iii. A body in the shape of a spring formed from nitinol; and / or

[0082] iv. An adjustable-sized body that can conform to the size and shape of a medical device; and

[0083] b) A medical device selected from a graft and a stent graft.

[0084] 12. A kit comprising a sensing attachment for a medical device and a medical device that may be associated with the sensing attachment, the kit comprising:

[0085] a) The sensing attachment, comprising:

[0086] 1. A sensor;

[0087] 2. A body adapted to reversibly attach to and detach from a medical device; and

[0088] 3. A communication interface configured to provide in-vivo communication to another device; and

[0089] b) A medical device selected from a graft and a stent graft.

[0090] 13. A kit comprising a sensing attachment for a medical device and a medical device that may be associated with the sensing attachment, the kit comprising:

[0091] a) The sensing attachment, comprising:

[0092] 1. Sensor;

[0093] 2. An elastic or superelastic body having a shape conforming around a tubular medical device such as a graft or a stent graft; and

[0094] 3. A communication interface configured to provide in vivo communication to another device; and

[0095] b) A medical device selected from a graft and a stent graft.

[0096] 14. A kit comprising a sensing attachment for a medical device and a medical device that may be associated with the sensing attachment, the kit comprising:

[0097] a) The sensing attachment, comprising:

[0098] 1. A body in the shape of a spring formed of nitinol;

[0099] 2. A sensor attached to the body; and

[0100] 3. A communication interface configured to provide in vivo communication to another device; and

[0101] b) A medical device selected from a graft and a stent graft.

[0102] 15. A kit comprising a sensing attachment for a medical device and a medical device that may be associated with the sensing attachment, the kit comprising:

[0103] a) The sensing attachment, comprising:

[0104] 1. Sensor;

[0105] 2. An adjustable body capable of conforming to the size and shape of a medical device; and

[0106] 3. A communication interface configured to provide in vivo communication to another device; and

[0107] b) A medical device selected from a graft and a stent graft.

[0108] In one aspect, the present disclosure provides an apparatus that includes a sensing attachment located within a delivery catheter. In one aspect, the present disclosure provides an apparatus that includes a system and a delivery catheter, wherein the system includes a sensing attachment associated with a graft, and wherein the system is located within the delivery catheter. In one aspect, the present disclosure provides an apparatus that includes a system and a delivery catheter, wherein the system includes a sensing attachment associated with a stent graft, and wherein the system is located within the delivery catheter. For example, in one embodiment, the present disclosure provides an apparatus that includes: a) a delivery catheter having a proximal end and a distal end and having a lumen extending therethrough, the lumen having a length and a cross-sectional area; b) a sensing attachment in a compressed state, the compressed sensing attachment being entirely located within the lumen of the delivery catheter; c) a pusher slidably disposed within the lumen of the delivery catheter, the pusher being adjacent to but not within the compressed sensing attachment; and d) a distally movable sheath that covers a first portion of the length of the inner lumen of the delivery catheter, wherein the first portion of the inner lumen contains a first portion of the pusher and a first portion of the sensing attachment in a compressed state; wherein the slidably disposed pusher engages the distally movable sheath such that sliding of the pusher causes movement of the movable sheath, wherein the movement exposes the first portion of the compressed sensing attachment and thereby allows the compressed sensing attachment to assume a less compressed form.

[0109] In one aspect, the present disclosure provides a method of manufacturing a sensing attachment, wherein the method includes: a) forming a body of the sensing attachment, wherein the body is at least one of the following: i) a body adapted to reversibly attach to and detach from a medical device; ii) an elastic or superelastic body having a shape adapted to fit around a tubular medical device such as a graft or a stent graft; iii) a body in the form of a spring formed from nitinol; and / or iv) a size-adjustable body adaptable to the size and shape of a medical device; b) forming an electronic assembly including a sensor and a communication interface; c) forming a power source; d) electrically coupling and fixedly attaching the power source to the electronic assembly; and e) fixedly attaching the electronic assembly and the power source to the body of the sensing attachment. Optionally, the body is formed by shaping nitinol filaments. Optionally, the body is in the form of a spring having a size and shape that fits around a stent graft and that is held against the outer surface of the stent graft by hoop stress. Optionally, the body is in the form of a spring having a size and shape that fits inside a stent graft and that is held against the inner surface of the stent graft by hoop stress.

[0110] In one aspect, the present disclosure provides a method for associating a sensing attachment with a medical device, for example by a method according to any one of the numbered embodiments below:

[0111] 1. A method for associating a sensing attachment with a medical device in a safe manner in vitro, the method comprising:

[0112] a) Selecting a medical device from a graft and a stent graft, wherein the medical device has an inner diameter and an outer diameter;

[0113] b) Selecting a sensing attachment having an inner diameter and an outer diameter, wherein at least one of the following: (i) the inner diameter of the sensing attachment is substantially the same as the outer diameter of the medical device; and (ii) the outer diameter of the sensing attachment is substantially the same as the inner diameter of the medical device;

[0114] c) Placing the sensing attachment inside or outside the medical device in vitro, wherein circumferential stress secures the sensing attachment to the medical device.

[0115] 2. A method for manufacturing a system comprising a medical device having a sensing attachment located therein, the method comprising:

[0116] a) Providing a medical device selected from a graft and a stent graft, the medical device having an interior and an exterior;

[0117] b) Determining the inner diameter of the medical device;

[0118] c) Selecting a sensing attachment having an interior and an exterior, the exterior having an outer diameter, wherein the outer diameter of the sensing attachment is substantially the same as the inner diameter of the medical device;

[0119] d) Compressing the sensing attachment from a non-compressed state to a compressed state, thereby reducing the inner diameter of the sensing attachment and placing the sensing attachment in a compressed state;

[0120] e) Placing the compressed sensing attachment at a location within the medical device having an inner diameter;

[0121] f) Allowing the sensing attachment to return to the non-compressed state such that the exterior of the sensing attachment contacts the interior of the medical device to provide a system comprising a medical device having a sensing attachment located therein.

[0122] 3. A method for manufacturing a system comprising a medical device and a sensing attachment located outside the medical device, the method comprising:

[0123] a) Providing a medical device selected from a graft and a stent graft, the medical device having an inner surface and an outer surface;

[0124] b) Selecting a sensing attachment having an interior and an exterior, the interior having an inner diameter, wherein the inner diameter of the sensing attachment is larger than the outer diameter of the medical device; and

[0125] c) Placing the sensing attachment around the medical device.

[0126] In one aspect, the present disclosure provides methods for implanting a sensing attachment within a patient while associating the sensing attachment with a medical device. For example, the present disclosure provides the following methods:

[0127] 1. A method comprising the steps of:

[0128] a) providing a first device comprising a stent graft contained within a first delivery catheter;

[0129] b) providing a second device comprising a sensing attachment contained within a second delivery catheter;

[0130] c) inserting the first device into a patient during a medical procedure and implanting the stent graft within the patient;

[0131] d) inserting the second device into a patient during a medical procedure and implanting the sensing attachment within the patient, the sensing attachment being implanted at a location adjacent to the stent graft;

[0132] e) removing the first delivery catheter from the patient; and

[0133] f) removing the second delivery catheter from the patient.

[0134] 2. A method comprising the steps of:

[0135] a) implanting a stent graft within a patient during a medical procedure to provide an implanted stent graft; and

[0136] b) implanting a sensing attachment within a patient during a medical procedure to provide an implanted sensing attachment;

[0137] c) wherein the implanted sensing attachment is adjacent to the implanted stent graft and wherein implanting the stent graft within the patient does not also effect implanting the sensing attachment within the patient.

[0138] 3. A method for associating a sensing attachment with a stent graft in a safe manner in vivo, the method comprising:

[0139] a) implanting a stent graft into a blood vessel of a patient during a medical procedure, the stent graft having an outer diameter;

[0140] b) providing a sensing attachment having an inner diameter, the inner diameter of the sensing attachment being substantially the same as the outer diameter of the stent graft; and

[0141] c) placing the sensing attachment around the stent graft in vivo during a medical procedure, wherein circumferential stress secures the sensing attachment to the stent graft.

[0142] 4. A method of associating a sensing attachment with a stent graft in a safe manner in vivo, the method comprising:

[0143] a) selecting a stent graft having an outer diameter;

[0144] b) implanting the stent graft into a patient's blood vessel during a medical procedure;

[0145] c) selecting a sensing attachment having an inner diameter, the inner diameter of the sensing attachment being substantially the same as the outer diameter of the stent graft; and

[0146] d) placing the sensing attachment around the stent graft in vivo during a medical procedure, wherein circumferential stress secures the sensing attachment to the stent graft.

[0147] In one aspect, the present disclosure provides methods for monitoring a patient in whom a sensing attachment has been implanted. For example, the present disclosure provides methods comprising the steps of:

[0148] a) obtaining information using a sensor secured to the sensing attachment, the sensing attachment being physically associated with, but not a component of, a medical device implanted in a patient, the medical device being selected from a stent graft and a graft; and

[0149] b) transmitting the information or a modified form thereof to a device located outside the patient.

[0150] Optionally, in a method of monitoring a patient using the sensing attachment of the present disclosure, one or more of the following may be used to describe the method: the sensing attachment is associated with an abdominal aortic aneurysm stent graft; the sensor obtains characteristic information of the pressure within the aneurysm sac; the sensor obtains characteristic information of the pressure within the stent graft located within the patient's abdominal aortic aneurysm; the sensor is a plurality of sensors; the sensor is a plurality of sensors located within an abdominal aortic aneurysm stent graft, wherein the plurality of sensors obtain characteristic information of a first blood pressure at the inlet of the stent graft and characteristic information of a second blood pressure at the outlet of the stent graft; the transmission of the information is by radio frequency transmission from the sensing attachment; the information is information regarding the presence or absence of endoleakage associated with the implanted stent graft; the information is information regarding the presence or absence of a partial obstruction of the blood flowing through the stent graft; the information is information regarding the presence or absence of a rupture in the stent graft; the information is information regarding the patient's cardiovascular condition; the information is information regarding the patient's cardiovascular condition, the cardiovascular condition being selected from myocardial infarction, congestive heart failure, arrhythmia, and renal failure.

[0151] When describing a sensing attachment, or a system or kit incorporating a sensing attachment, or a delivery system for a sensing attachment, or a method of manufacturing or using a sensing attachment, any one or more of the following may optionally be used: the body is in the form of a solid or hollow filament; the body is in the form of a monofilament or multifilament; the body is in the form of a hollow monofilament; the body is in the form of a hollow monofilament incorporating nitinol, wherein the hollow monofilament has a lumen; the body is in the form of a hollow monofilament incorporating nitinol, wherein the hollow monofilament has a lumen surrounded by the wall of the hollow monofilament, wherein the wall has an inner surface facing the lumen and an outer surface facing away from the lumen, and wherein the hollow monofilament has a plurality of incisions along its length, each incision extending from the outer surface of the hollow monofilament into the lumen of the hollow monofilament; the body is in the form of a hollow monofilament incorporating nitinol, wherein the hollow monofilament has a lumen surrounded by the wall of the hollow monofilament, wherein the wall has an inner surface facing the lumen and an outer surface facing away from the lumen, and wherein the hollow monofilament has a plurality of incisions along its length, each incision extending from the outer surface of the hollow monofilament into the lumen of the hollow monofilament, wherein the plurality of incisions are spaced 1-20 mm apart from each other; the body is in the form of a plurality of loops; the body is in the form of a spring; the body is in the form of a spring wound in a clockwise direction; the body is in the form of a spring wound in a counterclockwise direction; the body is in the form of a clip; the body is in the form of a ring; the body is in the form of a spring; the body is in the form of a clip or a cuff bracelet; the sensing attachment is biocompatible; the body is elastic or superelastic; the body includes a shape memory material; the body includes nitinol; the body includes an elastomeric plastic; the body has dimensions and a shape such that it can surround and abut against the outer surface of a stent graft; the body has dimensions and a shape such that it can surround and abut against the inner surface of a stent graft; the body has dimensions and a shape such that it can surround and abut against the inner surface of a graft; the sensing attachment is in a compressed form and is mounted within a delivery catheter for percutaneous delivery to a patient; the body includes a polymer coating on the body surface; the body includes a lubricating coating on the body surface; a sleeve is positioned around at least a portion of the body surface; the sensor of the sensing attachment is selected from fluid pressure sensors, fluid volume sensors, contact sensors, position sensors, pulse pressure sensors, blood volume sensors, blood flow sensors, chemical sensors (e.g., for blood and / or other fluids), metabolic sensors (e.g., for blood and / or other fluids), accelerometers, mechanical stress sensors, and temperature sensors; the sensor is a pressure sensor; the sensor is a plurality of pressure sensors; the sensor is a MEMS sensor; the sensor is sealed; the sensing attachment further includes a power source; the sensing attachment further includes a power source and an electronic component having various circuits powered by the power source, the electronic component including one or more components selected from fuses, switches, clock generators, and power management units, memories, and controllers; the communication interface of the sensing attachment includes a radio frequency (RF) transceiver and a filter coupled to an antenna; the communication interface of the sensing attachment includes a tissue conduction communication circuit coupled to a pair of electrodes; and / or the communication interface of the sensing attachment includes a sound data circuit coupled to an acoustic transducer.

[0152] In one embodiment, the sensing device of the present disclosure is designed to be added to a medical device before the device is provided to a patient. The medical device does not need to be physically modified in any way to accommodate the presence of the sensing device.

[0153] In an exemplary embodiment, and briefly stated, the present disclosure provides: a sensor including a housing, wherein the housing surrounds a detector, and the housing includes an extension that allows the sensor to be fixedly attached to a support; a construct including a sensor fixedly attached to a support, wherein the support can be firmly engaged with a medical device; and an assembly including a sensor, a support of the sensor, and a medical device, wherein the sensor is in direct contact with and fixedly attached to the support, and wherein the support is in direct contact with and firmly engaged with the medical device, wherein optionally, the sensor is not in direct contact with the medical device.

[0154] Additionally, the present disclosure provides a method of forming a construct, wherein the construct includes a sensor fixedly attached to a support, and wherein the support can be firmly engaged with a medical device; the method includes: a) providing a sensor including a housing, wherein the housing surrounds a detector, and the housing includes an extension that allows the sensor to be fixedly attached to a support; b) forming a support that can be firmly engaged with a medical device; c) fixedly attaching the sensor to the support during the formation of the support.

[0155] Additionally, the present disclosure provides a method of forming a construct, wherein the construct includes a sensor fixedly attached to a support, and wherein the support can be firmly engaged with a medical device; the method includes: a) providing a sensor including a housing, wherein the housing surrounds a detector, and the housing includes an extension that allows the sensor to be fixedly attached to a support; b) providing a support that can be firmly engaged with a medical device; c) fixedly attaching the sensor to the support before firmly engaging the support with the medical device.

[0156] In various embodiments of the present invention, one or more sensors may be positioned within, on, or inside a sensing attachment, including any location entirely within the sensing attachment, including, for example, on the outer (lumen) wall, inner (lumen) wall, between the inner and outer walls of the sensing attachment, or any combination thereof. In related embodiments, the sensor includes a plurality or multiple sensors (optionally, different types of sensors), which may be positioned on and / or within multiple surfaces of the sensing attachment. A variety of sensors may be used herein, including, 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 fluids), metabolic sensors (e.g., for blood and / or other fluids), accelerometers, mechanical stress sensors, temperature sensors, and the like. In certain embodiments, the sensor is a wireless sensor. In other embodiments, the sensor is connected to a wireless microprocessor. In other embodiments, the sensor is passive and thus does not require its own power source.

[0157] In various embodiments, a plurality of the aforementioned sensors are positioned on the sensing attachment, and in a preferred embodiment, the sensing attachment may contain more than one type of sensor (e.g., one or more or any combination of the following: fluid pressure sensor, contact sensor, position sensor, pulse pressure sensor, blood volume sensor, blood flow sensor, chemical sensor (e.g., for blood and / or other liquids), metabolic sensor (e.g., for blood and / or other liquids), accelerometer, mechanical stress sensor, temperature sensor, etc.).

[0158] In other aspects of the present invention, the stent graft includes two or more segments. In a preferred embodiment, the sensing attachment contains sensors that sense the connection of two or more segments.

[0159] In other embodiments, the sensing adjunct may include sensors at a particular density at a particular location. For example, the sensing adjunct may have a sensor density greater than 1 sensor per square centimeter, 2, 3, 4, 5, 6, 7, 8, 9, or 10 or more sensors per square centimeter, or if the calculation is volume-based, more than 1, 2, 3, 4, 5, 6, 7, 8, 9, or 10 sensors per cubic centimeter of the stent graft. (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 fluids), metabolic sensors (e.g., for blood and / or other fluids), accelerometers, mechanical stress sensors, temperature sensors, or any combination thereof). In related embodiments, the sensors (e.g., 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 fluids), metabolic sensors (e.g., for blood and / or other fluids), accelerometers, mechanical stress sensors, and temperature sensors) may be located at specific locations on or within the sensing adjunct.

[0160] In certain embodiments of the present invention, the sensing adjunct has a specific unique device identification number ("UDI"), and in other embodiments, each sensor on the sensing adjunct has a specific unique sensor identification number ("USI"), or a unique group identification number ("UGI", e.g., an identification number that identifies the sensor as one of a group of sensors, such as a fluid pressure sensor, contact sensor, position sensor, pulse pressure sensor, blood volume sensor, blood flow sensor, blood chemistry sensor, blood metabolic sensor, and / or mechanical stress sensor). In other embodiments, the USI is specifically associated with a location on the sensing adjunct.

[0161] In various embodiments, the sensing adjunct provided herein can be used to provide data identifying a variety of different conditions or diseases, including the development of type I, II, III, IV, and / or V endoleaks. In addition, the sensing adjunct can also provide specific cardiac measurements, including, for example, cardiac output, stroke volume, ejection fraction, systolic and / or diastolic blood pressure, mean arterial pressure, systemic vascular resistance, and total peripheral resistance. The sensing adjunct can also be used to measure and record temperature changes within the blood and / or vessel walls of a subject.

[0162] In other aspects of the present invention, methods are provided for monitoring a graft or stent graft, including the steps of: transmitting a radio signal from a location external to the body to a location internal to the body; receiving the signal at a sensor on a sensor attachment located internal to the body; powering the sensor using the received signal; sensing data at the sensor; and outputting the sensed data from the sensor to a receiving unit located external to the body. Optionally, power is provided to the sensor by an internal power source, such as a battery, rather than wirelessly. The integrity of the graft or stent graft can be interrogated wirelessly and the results reported periodically. This allows for regular or ad hoc checking of the patient's health status as needed by the patient and / or physician.

[0163] In other embodiments, each sensor includes a signal receiving circuit and a signal output circuit. The signal receiving circuit receives an interrogation signal that includes one or both of a power supply and a data collection request component. Using the power from the interrogation signal or an internal battery, the sensor powers the circuit portions required for sensing, performs the sensing, and then outputs the data to the interrogation module. The interrogation module operates under the control of a control unit that includes suitable I / O circuitry, memory, a controller in the form of a microprocessor, and other circuitry to drive the interrogation module. In other embodiments, sensors (e.g., fluid pressure sensors, contact sensors, position sensors, pulse pressure sensors, blood volume sensors, blood flow sensors, blood chemistry sensors, blood metabolite sensors, and / or mechanical stress sensors) are configured such that they can be easily mechanically attached to the sensing attachment (e.g., through an opening in the sensor housing or other attachment that provides a permanent attachment of the sensor to the sensing attachment).

[0164] In other aspects of the method of the present invention, devices are provided that are adapted to transmit a radio signal from a location external to the body to a location internal to the body; receive the signal at one of the above sensors on a sensing attachment located internal to the body; sense data at the sensor; and output the sensed data from the sensor to a receiving unit located external to the body. In certain embodiments, the receiving unit can provide an analysis of the signal provided by the sensor.

[0165] The following are some exemplary embodiments of the present disclosure, presented in numbered form for convenience.

[0166] 1. A sensing attachment for a medical device, the attachment comprising:

[0167] a) a sensor;

[0168] b) a communication interface configured to provide in vivo communication to another device; and at least one of the following:

[0169] i) a body adapted to reversibly attach to and detach from a medical device;

[0170] ii) An elastic or hyperelastic body having a shape conforming around a tubular medical device such as a graft or a stent graft;

[0171] iii) A body in the shape of a spring formed from nitinol; and / or

[0172] iv) An adjustable-size body capable of conforming to the size and shape of a medical device.

[0173] 2. The sensing attachment of embodiment 1, wherein the body is in the form of a solid or hollow filament.

[0174] 3. The sensing attachment of embodiment 1, wherein the body is in the form of a monofilament or multifilament.

[0175] 4. The sensing attachment of embodiment 1, wherein the body is in the form of a hollow monofilament.

[0176] 5. The sensing attachment of embodiment 1, wherein the body is in the form of a hollow monofilament containing nitinol, and wherein the hollow monofilament has a lumen.

[0177] 6. The sensing attachment of embodiment 1, wherein the body is in the form of a hollow monofilament containing nitinol, and wherein the hollow monofilament has a lumen surrounded by a wall of the hollow monofilament, and wherein the wall has an inner surface facing the lumen and an outer surface facing away from the lumen, and wherein the hollow monofilament has a plurality of incisions along its length, each incision extending from the outer surface of the hollow monofilament into the lumen of the hollow monofilament.

[0178] 7. The sensing attachment of embodiment 1, wherein the body is in the form of a hollow monofilament containing nitinol, and wherein the hollow monofilament has a lumen surrounded by a wall of the hollow monofilament, and wherein the wall has an inner surface facing the lumen and an outer surface facing away from the lumen, and wherein the hollow monofilament has a plurality of incisions along its length, each incision extending from the outer surface of the hollow monofilament into the lumen of the hollow monofilament, and wherein the plurality of incisions are spaced 1 - 20 mm apart from each other.

[0179] 8. The sensing attachment of embodiment 1, wherein the body is in the form of a plurality of loops.

[0180] 9. The sensing attachment of any one of embodiments 1 - 7, wherein the body is in the shape of a spring.

[0181] 10. The sensing attachment of any one of embodiments 1 - 7, wherein the body is in the shape of a spring wound in a clockwise direction.

[0182] 11. The sensing attachment of any one of embodiments 1 - 7, wherein the body is in the shape of a spring wound in a counterclockwise direction.

[0183] 12. The sensing attachment of any one of embodiments 1-7, wherein the body is in the shape of a clip.

[0184] 13. The sensing attachment of any one of embodiments 1-7, wherein the body is in the shape of a ring.

[0185] 14. The sensing attachment of any one of embodiments 1-7, wherein the body comprises a hollow monofilament in the shape of a spring.

[0186] 15. The sensing attachment of any one of embodiments 1-7, wherein the body is in the shape of a clip or a cuff bracelet.

[0187] 16. The sensing attachment of any one of embodiments 1-15, wherein the sensing attachment is biocompatible.

[0188] 17. The sensing attachment of any one of embodiments 1-16, wherein the body is elastic or superelastic.

[0189] 18. The sensing attachment of any one of embodiments 1-17, wherein the body comprises a shape memory material.

[0190] 19. The sensing attachment of any one of embodiments 1-18, wherein the body comprises nitinol.

[0191] 20. The sensing attachment of any one of embodiments 1-4 and 8-18, wherein the body comprises an elastic plastic.

[0192] 21. The sensing attachment of any one of embodiments 1-20, wherein the body has dimensions and a shape that allow it to fit against and abut the outer surface of a stent graft.

[0193] 22. The sensing attachment of any one of embodiments 1-20, wherein the body has dimensions and a shape that allow it to fit against and abut the inner surface of a stent graft.

[0194] 23. The sensing attachment of any one of embodiments 1-20, wherein the body has dimensions and a shape that allow it to fit against and abut the inner surface of a graft.

[0195] 24. The sensing attachment in a compressed form of any one of embodiments 1-23, which fits inside a delivery catheter for percutaneous delivery to a patient.

[0196] 25. The sensing attachment of any one of embodiments 1-24, wherein the body comprises a polymer coating on the body surface.

[0197] 26. The sensing attachment of any one of embodiments 1-24, wherein the body comprises a smooth coating on the body surface.

[0198] 27. The sensing attachment of any one of embodiments 1-24, wherein the cuff is located around at least a portion of the body surface.

[0199] 28. In the sensing attachment of any one of embodiments 1-27, wherein the sensor is selected from a fluid pressure sensor, a fluid volume sensor, a contact sensor, a position sensor, a pulse pressure sensor, a blood volume sensor, a blood flow sensor, a chemical sensor (e.g., for blood and / or other fluids), a metabolic sensor (e.g., for blood and / or other fluids), an accelerometer, a mechanical stress sensor, and a temperature sensor.

[0200] 29. The sensing attachment of any one of embodiments 1-27, wherein the sensor is a pressure sensor.

[0201] 30. The sensing attachment of any one of embodiments 1-29, wherein the sensor is a plurality of pressure sensors.

[0202] 31. The sensing attachment of any one of embodiments 1-30, wherein the sensor is a MEMS sensor.

[0203] 32. The sensing attachment of any one of embodiments 1-31, wherein the sensor is sealed.

[0204] 33. The sensing attachment of any one of embodiments 1-32, further comprising a power source.

[0205] 34. The sensing attachment of any one of embodiments 1-32, further comprising a power source and an electronic assembly having various circuits powered by the power source, the electronic assembly including one or more components selected from a fuse, a switch, a clock generator, and a power management unit, a memory, and a controller.

[0206] 35. The sensing attachment according to any one of embodiments 1-34, wherein the communication interface comprises a radio frequency (RF) transceiver and a filter coupled to an antenna.

[0207] 36. The sensing attachment according to any one of embodiments 1-34, wherein the communication interface comprises a tissue conduction communication circuit coupled to a pair of electrodes.

[0208] 37. The sensing attachment according to any one of embodiments 1-34, wherein the communication interface comprises a data sound circuit coupled to an acoustic transducer.

[0209] 38. A kit comprising the sensing attachment of any one of embodiments 1-37 and a stent graft.

[0210] 39. A kit comprising the sensing attachment of any one of embodiments 1 - 37 and a graft.

[0211] 40. A system comprising the sensing attachment of any one of embodiments 1 - 37 associated with a stent graft.

[0212] 41. A system comprising the sensing attachment of any one of embodiments 1 - 37 associated with a graft.

[0213] 42. A device comprising the sensing attachment of any one of embodiments 1 - 37 located within a delivery catheter.

[0214] 43. A device comprising a system and a delivery catheter, the system comprising the sensing attachment of any one of embodiments 1 - 37 associated with a graft, the system being located within the delivery catheter.

[0215] 44. A device comprising a system and a delivery catheter, the system comprising the sensing attachment of any one of embodiments 1 - 37 associated with a stent graft, the system being located within the delivery catheter.

[0216] 45. A device comprising:

[0217] a) A delivery catheter having a proximal end and a distal end and having a lumen extending therethrough, the lumen having a length and a cross - sectional area;

[0218] b) The sensing attachment of any one of embodiments 1 - 37 in a compressed state, the compressed sensing attachment being entirely located within the lumen of the delivery catheter;

[0219] c) A pusher slidably disposed within the lumen of the delivery catheter, the pusher being adjacent to the compressed sensing attachment rather than within the compressed sensing attachment; and

[0220] d) A distally movable sheath covering a first portion of the length of the inner lumen of the delivery catheter, wherein the first portion of the lumen contains a first portion of the pusher and a first portion of the sensing attachment in a compressed state;

[0221] wherein the slidably disposed pusher engages the distally movable sheath such that sliding of the pusher causes movement of the movable sheath, wherein the movement exposes the first portion of the compressed sensing attachment and thereby allows the compressed sensing attachment to assume a less compressed form.

[0222] 46. A method of manufacturing the sensing attachment of any one of embodiments 1 - 37, comprising:

[0223] a) Forming a body of the sensing attachment, wherein the body is at least one of the following:

[0224] i) A body adapted to be reversibly attached to and detached from a medical device;

[0225] ii) An elastic or superelastic body having a shape conforming around a tubular medical device such as a graft or a stent graft;

[0226] iii) A body in the form of a spring formed from nitinol; and / or

[0227] iv) A size-adjustable body capable of conforming to the size and shape of a medical device;

[0228] b) Forming an electronic assembly including a sensor and a communication interface;

[0229] c) Forming a power source;

[0230] d) Electrically coupling and fixedly connecting the power source to the electronic assembly; and

[0231] e) Fixedly attaching the electronic assembly and the power source to the body of the sensing attachment.

[0232] 47. The method of embodiment 46, wherein the body is formed by setting the shape of nitinol filaments.

[0233] 48. The method of embodiment 46, wherein the body is in the form of a spring having a shape conforming around a stent graft and maintaining its size and shape against the outer surface of the stent graft by hoop stress.

[0234] 49. The method of embodiment 46, wherein the body is in the form of a spring having a shape conforming within a stent graft and maintaining its size and shape against the inner surface of the stent graft by hoop stress.

[0235] 50. A method comprising the following steps:

[0236] a) Providing a first device including a stent graft contained within a first delivery catheter;

[0237] b) Providing a second device including a sensing attachment according to one of embodiments 1 - 37 contained within a second delivery catheter;

[0238] c) Inserting the first device into a patient during a medical procedure and implanting the stent graft in the patient;

[0239] d) Inserting the second device into a patient during a medical procedure and implanting the sensing attachment in the patient, the sensing attachment being implanted at a location adjacent to the stent graft;

[0240] e) Removing the first delivery catheter from the patient; and

[0241] f) Removing the second delivery catheter from the patient.

[0242] 51. A method comprising the following steps:

[0243] a) implanting a stent graft into a patient during a medical procedure to provide an implanted stent graft; and

[0244] b) implanting a sensing attachment according to any one of embodiments 1-37 into the patient during a medical procedure to provide an implanted sensing attachment;

[0245] c) wherein the implanted sensing attachment is adjacent to the implanted stent graft, and wherein implanting the stent graft into the patient does not also effect implanting the sensing attachment into the patient.

[0246] 52. A method of associating a sensing attachment with a stent graft in a safe manner in vivo, the method comprising:

[0247] a) implanting a stent graft into a blood vessel of a patient during a medical procedure, the stent graft having an outer diameter;

[0248] b) providing a sensing attachment according to any one of embodiments 1-37 having an inner diameter, wherein the inner diameter of the sensing attachment is substantially the same as the outer diameter of the stent graft; and

[0249] c) placing the sensing attachment around the stent graft in vivo during a medical procedure, wherein hoop stress secures the sensing attachment to the stent graft.

[0250] 53. A method of associating a sensing attachment with a stent graft in a safe manner in vivo, the method comprising:

[0251] a) selecting a stent graft having an outer diameter;

[0252] b) implanting the stent graft into a blood vessel of a patient during a medical procedure;

[0253] c) selecting a sensing attachment according to any one of embodiments 1-37 having an inner diameter, wherein the inner diameter of the sensing attachment is substantially the same as the outer diameter of the stent graft; and

[0254] d) placing the sensing attachment around the stent graft in vivo during a medical procedure, wherein hoop stress secures the sensing attachment to the stent graft.

[0255] 54. A method of associating a sensing attachment with a medical device in a safe manner in vitro, the method comprising:

[0256] a) selecting a medical device from a graft and a stent graft, wherein the medical device has an inner diameter and an outer diameter;

[0257] b) Select a sensing attachment according to any one of Embodiments 1 - 37 having an inner diameter and an outer diameter, wherein at least one of the following: (i) the inner diameter of the sensing attachment is substantially the same as the outer diameter of the medical device; and (ii) the outer diameter of the sensing attachment is substantially the same as the inner diameter of the medical device;

[0258] c) Place the sensing attachment inside or outside the medical device in vitro, wherein circumferential stress secures the sensing attachment to the medical device.

[0259] 55. A method of manufacturing a system including a medical device having a sensing attachment located within the medical device, the method comprising:

[0260] a) Provide a medical device selected from a graft and a stent graft, the medical device having an interior and an exterior;

[0261] b) Determine the inner diameter of the medical device;

[0262] c) Select a sensing attachment according to any one of Embodiments 1 - 37 having an interior and an exterior, the exterior having an outer diameter, wherein the outer diameter of the sensing attachment is substantially the same as the inner diameter of the medical device;

[0263] d) Compress the sensing attachment from a non - compressed state to a compressed state, thereby reducing the inner diameter of the sensing attachment and placing the sensing attachment in a compressed state;

[0264] e) Place the compressed sensing attachment at a location within the medical device having an inner diameter;

[0265] f) Allow the sensing attachment to return to the non - compressed state such that the exterior of the sensing attachment contacts the interior of the medical device to provide a system including a medical device having a sensing attachment located within the medical device.

[0266] 56. A method of manufacturing a system including a medical device and a sensing attachment located outside the medical device, the method comprising:

[0267] a) Provide a medical device selected from a graft and a stent graft, the medical device having an inner surface and an outer surface;

[0268] b) Select a sensing attachment according to any one of Embodiments 1 - 37 having an interior and an exterior, the interior having an inner diameter, wherein the inner diameter of the sensing attachment is larger than the outer diameter of the medical device; and

[0269] c) Place the sensing attachment around the medical device.

[0270] 57. A method for monitoring a patient, the method comprising:

[0271] a) Obtaining information using a sensor fixed to a sensing attachment according to any one of embodiments 1-37, the sensing attachment being physically associated with, but not a component of, a medical device implanted in a patient, the medical device being selected from a stent graft and a graft; and

[0272] b) Transmitting the information or a modified form thereof to a device located outside the patient.

[0273] 58. The method according to embodiment 57, wherein the sensing attachment is associated with an abdominal aortic aneurysm stent graft.

[0274] 59. The method according to embodiment 57, wherein the sensor obtains characteristic information of the pressure within the aneurysm sac.

[0275] 60. The method according to embodiment 57, wherein the sensor obtains characteristic information of the pressure within the stent graft located within the patient's abdominal aortic aneurysm.

[0276] 61. The method of embodiment 57, wherein the sensor is a plurality of sensors.

[0277] 62. The method of embodiment 57, wherein the sensor is a plurality of sensors located within the abdominal aortic aneurysm, wherein the plurality of sensors obtain characteristic information of a first blood pressure at the inlet of the stent graft and characteristic information of a second blood pressure at the outlet of the stent graft.

[0278] 63. The method of embodiment 57, wherein the information is transmitted by radio frequency transmission from the sensing attachment.

[0279] 64. The method of embodiment 57, wherein the information is information regarding the presence or absence of endoleak associated with the implanted stent graft.

[0280] 65. The method of embodiment 57, wherein the information is information regarding the presence or absence of a partial blockage of flow through the stent graft.

[0281] 66. The method of embodiment 57, wherein the information is information regarding the presence or absence of a rupture within the stent graft.

[0282] 67. The method of embodiment 57, wherein the information is information regarding the patient's cardiovascular disorder.

[0283] 68. The method of embodiment 57, wherein the information is information regarding the patient's cardiovascular disorder, the cardiovascular disorder being selected from myocardial infarction, congestive heart failure, arrhythmia, and renal failure.

[0284] For example, in an embodiment, the present disclosure provides a sensing attachment for a medical device, and a system including the sensing attachment associated with a medical device, wherein the sensing attachment includes a sensor; a communication interface configured to provide in vivo communication to another device; and a body including a spring-shaped monofilament that conforms to and abuts an inner or outer surface of a tubular medical device selected from a graft or a stent graft, wherein the body is adapted to reversibly attach to and detach from the medical device; and wherein the sensor is directly or indirectly fixed to the body of the sensing attachment. In one embodiment, the spring is wound in a clockwise direction. Optionally, the body has dimensions and a shape that allow it to conform to and abut the outer surface of a stent graft. Optionally, the body has dimensions and a shape that allow it to conform to and abut the inner surface of a stent graft. Optionally, the sensing attachment is associated with the inner or outer surface of a stent graft. In either case, the body optionally includes a coating on its surface, such as a polymer coating, e.g., a polymer coating that reduces wear between the sensing attachment and the associated medical device. In one embodiment, the spring is wound in a counterclockwise direction. Optionally, the body is in the form of a hollow monofilament including nitinol and has a lumen surrounded by the wall of the hollow monofilament, wherein the wall has an inner surface facing the lumen and an outer surface facing away from the lumen, and wherein the hollow monofilament has a plurality of incisions along its length, each incision extending from the outer surface of the hollow monofilament into the lumen of the hollow monofilament. Optionally, the sensing attachment is biocompatible. Optionally, the sensor and any associated circuitry are contained in a sealed housing. Optionally, the sensor can be a MEMS sensor, and the sensor can be selected from a fluid pressure sensor, a fluid volume sensor, a contact sensor, a position sensor, a pulse pressure sensor, a blood volume sensor, a blood flow sensor, a chemical sensor (e.g., for blood and / or other fluids), a metabolic sensor (e.g., for blood and / or other fluids), an accelerometer, a mechanical stress sensor, and a temperature sensor, including any one or more of the listed sensors. In one embodiment, the sensor is a pressure sensor. In one embodiment, the sensor is a plurality of sensors, e.g., a plurality of pressure sensors. The sensing attachment may also include other components, such as a power source and an electronic assembly having various circuits powered by the power source, wherein the electronic assembly may include one or more components selected from a fuse, a switch, a clock generator, and a power management unit, a memory, and a controller. In one embodiment, the communication interface includes a radio frequency (RF) transceiver and a filter coupled to an antenna. The sensing attachment can be used in the methods disclosed herein, and a sensing attachment associated with or combined with a stent graft or a graft can be prepared and used according to the methods described herein.

[0285] The above and other features of the present invention and the manner of obtaining them will become apparent and the present invention will be best understood by reference to the following more detailed description. All references disclosed herein are incorporated herein by reference in their entirety as if each reference was incorporated individually.

[0286] This brief summary is provided to introduce some concepts in a simplified form that will be further described in detail below. Unless otherwise expressly stated, this brief summary is not intended to identify key or essential features of the claimed subject matter nor is it intended to limit the scope of the claimed subject matter.

[0287] Details of one or more embodiments are set forth in the following description. Features illustrated or described in connection with one exemplary embodiment may be combined with features of other embodiments. Accordingly, any of the various embodiments described herein may be combined to provide other embodiments. Aspects of the embodiments may be modified as necessary to incorporate concepts of various patents, applications, and publications identified herein to provide further embodiments. Other features, objects, and advantages will be apparent from the description, drawings, and claims.

[0288] Brief Description of the Drawings

[0289] Exemplary features of the present disclosure, their nature, and various advantages will be apparent from the following detailed description of the drawings and various embodiments. Non-limiting and non-exhaustive embodiments are described with reference to the drawings, wherein like labels or reference numerals refer to like components in the various views unless otherwise indicated. The size and relative positions of the elements in the drawings are not necessarily drawn to scale. For example, the shapes of the various elements are selected, enlarged, and positioned to enhance the readability of the drawings. Specific shapes of the drawn elements have been selected for ease of identification in the drawings. One or more embodiments are described below in connection with the drawings, wherein:

[0290] Figure 1 is a front perspective view showing an exemplary body of the sensing attachment in the form of a filament and having a wavy loop shape.

[0291] Figure 2A is a front view, and Figure 2B is an upper right perspective view, each showing an exemplary body of the sensing attachment in the form of a plurality of adjacent loops. Figure 2A shows a portion of the body. Figure 2B shows a portion of the body in the shape of a clip, also referred to as a cuff bracelet shape.

[0292] Figure 3A , Figure 3B and Figure 3C are each front views showing an exemplary body of the sensing attachment, each in the form of a clip.Figure 3A shows a filament in the shape of a classic paper clip, Figure 3B shows a filament in the shape of a paper clip, and Figure 3C shows a sheet that has been cut into the shape of a paper clip.

[0293] Figure 4A and Figure 4B each is a right front perspective view showing an exemplary body of the sensing attachment, each in the form of a clip. Figure 4A shows a sheet in the shape of a clip, while Figure 4B shows a filament in the shape of a clip, where the clip shape can also be referred to as a cuff bracelet shape.

[0294] Figure 5A is a perspective view showing an exemplary body of the sensing attachment, the body being in the form of a filament and a spring shape, where Figure 5B shows Figure 5A a cross-sectional view of the filament of Figure 5A and particularly shows the circular cross-section of the filament of

[0295] Figure 5C is a perspective view showing an exemplary body of the sensing attachment, the body being in the form of a filament and a spring shape, where Figure 5D shows Figure 5C a cross-sectional view of the filament of Figure 5C and particularly shows the flat cross-section of the filament of

[0296] Figure 6 is a lower right perspective view showing an exemplary body of the sensing attachment, the body being in the form of a hollow monofilament with a cutout therein, and a spring shape.

[0297] Figure 7A is a front view showing the body of the sensing attachment of Figure 1 in its natural, uncompressed and unextended dimensions, while Figure 7B is a front view showing the same body in a radially expanded dimension.

[0298] Figure 8 is a block diagram showing the components of an exemplary implantable reporting processor (IRP) including a sensor.

[0299] Figure 9A 、 Figure 9B 、 Figure 9C and Figure 9D each is a left front perspective view, each view showing an embodiment for fixedly attaching a sensor to a support.

[0300] Figure 10 is a front perspective view showing a construct including a sensor fixedly attached to a support.

[0301] Figure 11 It is a front view showing another view of the structure including a sensor fixedly attached to a support.

[0302] Figure 12 It shows Figure 11 A detailed view of an expanded view of a part, showing the relative placement of the support element and the sensor.

[0303] Figure 13A and Figure 13B is a front view showing that the structure can be adjusted to the expanded form as in Figure 13B or the compact form as in Figure 13A .

[0304] Figure 14 It is a top view showing the sensor and other components of the sensing attachment of the spline 63 firmly attached to the Figure 6 body.

[0305] Figure 15 It is a partial cross-sectional view of a blood vessel, which is a front view of an assembly including a sensor, a support for the sensor, and a medical device, where the sensor is in direct contact with and fixedly attached to the support, and where the support is in direct contact with and firmly engaged with the medical device.

[0306] Figure 16 It is a partial cross-sectional view of a blood vessel, which is a front view of a stent graft associated with two sensing attachments, one (420) in the shape of a clip and the other (422) in the shape of a pair of forceps, each sensing attachment being firmly attached to the stent graft.

[0307] Figure 17 It is a partial cross-sectional view of a blood vessel, which is a front view of a stent graft associated with a sensing attachment having the spring shape shown in the perspective view, being firmly associated with the stent graft.

[0308] Figure 18 It is a partial cross-sectional view of a blood vessel, which is a stent graft shown in the front view and also shows an assembly including a structure that includes a sensor and a support, the structure being closely associated with a medical device, in this case an endovascular graft.

[0309] Figure 19 It is a partial cross-sectional view of a blood vessel, which is a stent graft shown in the front view and also shows an assembly including a structure that includes a sensor and a support, the structure being closely associated with a medical device, in this case an endovascular graft.

[0310] Figure 20Is an isometric view of a delivery system configured to deliver a sensing attachment or a combination of sensing attachments associated with a medical device to a patient.

[0311] Figure 21 Is Figure 20 A side view of a delivery catheter of the delivery system, showing the position of a sensing attachment or a combination of sensing attachments associated with a medical device as contained within the delivery catheter.

[0312] Figure 22 Is an environmental view of the sensing attachment environment in a patient's home. DETAILED DESCRIPTION OF THE INVENTION

[0314] The present invention can be more readily understood by reference to the following detailed description of the preferred embodiments of the invention and the examples included herein. In reading this detailed description, and unless otherwise explained, all technical and scientific terms used herein have the same meaning as commonly understood by one of ordinary skill in the art to which this disclosure pertains. The singular terms "a," "an," and "the" include plural referents unless the context clearly dictates otherwise. Similarly, the word "or" is intended to include "and" unless the context clearly dictates otherwise. The term "comprises" means "includes." The abbreviation, "e.g.", derived from the Latin exempli gratia, is used herein to denote a non-limiting example. Thus, the abbreviation "e.g." is synonymous with the term "for example."

[0315] In one aspect, the present disclosure provides standalone sensing attachments and related systems that work in conjunction with approved medical devices, treatment methods, and procedures. The sensing attachments are independent of the medical devices in that the sensing attachments are not necessarily components or integral parts of the medical devices, but are attached or otherwise secured to a standalone and fully functional medical device, where the attachment is made in a reversible manner. The sensing attachments include sensors that can detect and / or measure characteristics in the vicinity of the attachment. For example, the sensing attachments can measure any one or more of hydrodynamic properties such as flow and / or pressure, the presence of biomarkers such as infection markers and / or inflammation markers, and / or the detection of particles within the human arterial or venous vascular system. In one aspect, data obtained from the sensors or a modified form of the data is transmitted to an external receiver for data integration and analysis.

[0316] On the one hand, the present disclosure provides a sensing attachment that can be used in combination with a medical device, optionally a medical device that has been implanted in a patient, i.e., an implanted medical device. The sensing attachment includes sensors, i.e., includes one or more sensors, where the sensors can detect and / or measure conditions specific to features near the sensing attachment, i.e., one or more conditions. In one embodiment, the sensing attachment can be in direct contact with the medical device. In one embodiment, the sensing attachment is very close to the medical device, such as within a few centimeters of the medical device, i.e., 1 or 2 or 3 centimeters. In addition to the sensors, the sensing attachment also includes a body that serves to hold the sensing attachment in a desired position. The sensors can be directly fixed to the body, for example, by gluing or welding the sensors to the body. In one embodiment, the sensors are contained within a specially designed housing that provides for securely fixing the sensors to the sensing attachment, e.g., to the body of the sensing attachment.

[0317] On the one hand, the body of the sensing attachment is or includes a filament. As used herein, a filament refers to a form that is very long compared to its width and height. Optionally, the filament has the same width and height, in which case the filament has a circular cross-section, such as is present in a typical wire having a circular cross-section. However, the filaments of the present disclosure do not necessarily have equal width and height dimensions, i.e., are not necessarily circular. In one embodiment, the width is relatively small and the height is relatively large, such that the filament has a cross-section that can be described as flat. In this case, the filament can be described as a flat filament having two sides. This form is widely referred to in the wire industry as a flat wire. In a flat filament, the edges can be rounded, or they can be sharp, i.e., the flat wire has square edges. The opposite sides of the flat filament may or may not have the same profile.

[0318] The filament can optionally be a solid filament, such as a wire. The filament can optionally be a hollow filament, such as a tube. The filament can be a monofilament, rather than, for example, a multifilament. Thus, in some aspects, the present disclosure provides a body in the form of a solid monofilament and a body in the form of a hollow monofilament. The present disclosure also provides a body in the form of a multifilament.

[0319] In one embodiment, the body is formed from a single filament, such as a single hollow monofilament. In one embodiment, the body is formed from multiple filaments, such as a mixture of solid monofilaments and hollow monofilaments. For clarity, in a multifilament, each filament of the multifilament follows the same spatial path because the individual filaments of the multifilament are joined together along their entire length. In contrast, each individual filament present in a body formed from multiple filaments can follow its own spatial path because in this case, the individual filaments are not joined together along their entire length.

[0320] In one embodiment, the body is formed in whole or in part from a single filament. In one embodiment, the body is formed in whole or in part from a single monofilament. In one embodiment, the body is formed in whole or in part from a single solid monofilament. In one embodiment, the body is formed in whole or in part from a single hollow monofilament. In one embodiment, the body is formed in whole or in part from multifilaments. In one embodiment, the body is formed in whole or in part from a single multifilament. In one embodiment, the body is formed in whole or in part from a single multifilament comprising a plurality of solid monofilaments. In one embodiment, the body is formed in whole or in part from a single multifilament comprising a plurality of hollow monofilaments.

[0321] For example, a body made from a plurality of monofilaments can have the form of a plurality of loops, each loop made from a monofilament, where the loops are locked together. For example, a central loop can be connected to two adjacent loops, where each adjacent loop is further attached to another new loop, etc., to provide a form of a plurality of loops connected together. This form can be described as a chain, where each monofilament provides a link for the chain.

[0322] In one embodiment, the body is formed in whole or in part from a sheet, where a sheet refers to a form that is very thin compared to its length and width.

[0323] The body of the sensing attachment can be described according to its shape. The body, such as a filament or a sheet, can adopt various shapes. In one embodiment, the shape provides a body of a size that matches the sensing attachment, which can conform to the size and shape of the respiratory therapy device of the sensing attachment associated therewith. In one embodiment, the shape provides an adjustable-size body for the sensing attachment, which can be adjusted to the size and shape of the medical device associated with the sensing attachment during operation of the medical device within a patient's body when the medical device undergoes size and / or shape changes. In one embodiment, the shape provides a feature that the sensing attachment can be reversibly attached to and detached from the medical device, i.e., the body holds the sensing attachment in the desired position without any physical mechanical connection of the sensing attachment to the medical device.

[0324] In one embodiment, the body has or comprises the shape of a wavy filament that is annular as a whole, i.e., the filament has no starting or ending point. Such a body is shown in Figure 1 which shows a body 10 made from a filament 12, where the filament follows a wavy path when it forms a loop shape. The wavy path can also be described as a sine curve in the sense that the path turns to the right, then turns to the left after a distance, then turns to the right again after a further distance, etc.

[0325] In one embodiment, the body has the shape of a plurality of rings connected together to form a chain. Optionally, each ring can pass through two adjacent rings, forming a flexible chain like a link. Optionally, each ring is fixedly attached to two adjacent rings, where such a body is shown in Figure 2A which shows a body 20 made of filaments 22, the filaments 22 being in a loop shape, and the body 20 having a plurality of rings fixedly connected together ( Figure 2A five rings are shown).

[0326] In one embodiment (not shown), a series of adjacent rings form an annular chain because there is no specific ring that can be said to be the first or the last ring, and this shape can also be called a bracelet shape. In another embodiment, as shown in Figure 2B , a series of adjacent rings 24 are not completely circular, but have a starting ring and an ending ring, with a plurality of rings 26 in between. In Figure 2B , a series of rings form a clip shape, also called a cuff bracelet shape. In another embodiment (not shown), the plurality of rings are in the form of a spring.

[0327] In one embodiment, the body has or includes a clip shape. The clip is designed to be fixed or attached to the edge of a medical device in a secure manner. Exemplary shapes of the clip are shown in Figure 3A , Figure 3B and Figure 3C . These clips function effectively in the same way as a paper clip that can be attached to a piece of paper.

[0328] Figure 3A shows a body 30 in the shape of a classic paper clip made of filaments 32. Figure 3B shows a body 32 in a common paper clip shape made of filaments 34. Figure 3C shows a body 37 made of a sheet 38, the sheet including a cutout 39 to provide a body in the shape of a paper clip.

[0329] In one embodiment, the support structure has or includes a clip shape. Exemplary clip shapes are shown in Figure 4A . The body 40 is in the shape of a clip. Figure 4A has the form of a strip of material, where the form has been shaped into a semi-circle, where the semi-circle extends more than 180 degrees but less than 360 degrees, such that the semi-circular clip 40 includes a gap 44. Figure 4B The clip 46 shown in Figure 4A is made of filaments 48 instead of a sheet of material, where the filaments 478 effectively trace the edge of the clip of Figure 4A and also includes a gap 48.

[0330] In one embodiment, the body has or includes a spring shape. The spring has a surface in the shape of a helix, created by sweeping a circle around a helical path. In one embodiment, the helix is wound in a clockwise direction. In one embodiment, the helix is wound in a counterclockwise direction. The direction can be selected according to, for example, the expected path that a sensing attachment can take when implanted for percutaneous delivery.

[0331] An exemplary spring is shown in Figure 5A . Figure 5A The body 50 in Figure 5B is made of a circular monofilament 52, where the monofilament 52 is shown in cross-section in Figure 5C , where the cross-section is circular. Thus, the spring 50 is made of a solid monofilament 52. Another exemplary spring is shown in Figure 5C . Figure 5D The spring 54 in

[0332] is made of a flat monofilament 56, where the monofilament 56 is shown in cross-section in Figure 5A and Figure 5C , where the cross-section is substantially flat rather than circular. Thus, the spring 54 is made of a flat solid monofilament 56. Figure 5A In Figure 5C and

[0333] the body in the form of a spring is shown as being formed from solid filaments, such as the solid circular filaments shown in Figure 6 or the substantially flat filaments shown in Figure 6 . However, the spring shape is not limited to being formed from solid or flat filaments. In another embodiment, the spring is formed from a hollow monofilament, such as a hollow monofilament having a circular cross-section.

[0334] When cutting is performed in the filaments, in one option, the cuts are the same along the length of the filaments. That is, each cut starts on the same side of the filament and each cut extends into the filament a fixed distance that is less than the diameter of the filament. This option may be referred to as straight-cut hollow tubes and is shown in Figure 6 . In this option, the hollow monofilament with cuts has ridges 63, also known as splines or lamellas, where these terms all refer to the long, narrow, thin strips of material that form the tube and where there are no cuts present. The greater the cutting depth, the narrower the spline. In an embodiment, the spline has a width less than 25% of the filament circumference, or less than 20% of the filament circumference, or less than 15%, or less than 10%.

[0335] Referring again to Figure 6 , a series of loops extend from the splines, and three such loops are shown as features 64a, 64b, and 64c in Figure 6 . The loops can be defined in part by their length. In one embodiment, cuts are made in the hollow monofilament every 6 mm such that the loops have a length of approximately 6 mm (slightly less than 6 mm since the cuts will remove a small amount of material). Generally speaking, all other factors being equal, greater compliance can be achieved when the loop length is shorter. In an embodiment, the loop length is less than 20 mm, or less than 15 mm, or less than 10 mm, or less than 8 mm. However, if the loop length is too short relative to the diameter of the hollow monofilament, the resulting spring does not have much strength to maintain its shape. In an embodiment, the loops have a length of at least 4 mm, or at least 5 mm, or at least 6 mm, or at least 7 mm, or at least 8 mm, or at least 9 mm, or at least 10 mm. In an embodiment, the hollow monofilament has a plurality of loops that have a length of 1 - 20 mm, or 2 - 10 mm, or 3 - 8 mm, or 5 - 7 mm. In an embodiment, the hollow monofilament has a diameter less than 10 mm, or less than 9 mm, or less than 8 mm, or less than 7 mm, or less than 6 mm, or less than 5 mm, or less than 4 mm, including ranges formed by any two of the listed values, for example, a diameter in the range of 4 - 6 mm.

[0336] To provide the subject matter of the present disclosure, the cuts can be made regularly and identically along the length of the hollow monofilament, and this is the case in Figure 6Shown in. However, the incisions can be such a pattern that each incision is different from the previous (adjacent) incision, but varies along the length of the hollow monofilament by some fixed parameters. For example, the beginning of the incision can be offset by a fixed degree compared to the previous incision. Structures can be envisioned, such as those formed by rotating the hollow monofilament a fixed amount around its longitudinal axis after each cut, such that the resulting splines have a helical shape, also known as a helical or sinusoidal shape. The resulting cut pattern is an example of a cross-hinged pattern, where cross-hinging is known in the field of laser cutting of hollow monofilaments and provides a greater variation in cutting and cut patterns. Generally, the hollow monofilaments of the present disclosure can be cut into any cross-hinged pattern to provide the body of the sensing attachment of the present disclosure.

[0337] On the one hand, the body of the sensing attachment of the present disclosure conforms to the shape and / or dimensions of a medical device placed against the construct. Thus, if the medical device is, for example, a graft having a tubular shape and the body is wound around the exterior of the tubular graft in a helical manner, the body of the present disclosure can contract in size to be in direct contact with the fabric of the graft and adopt the shape and dimensions of the tubular graft. This property of the body of the present disclosure will be referred to as compliance, and in one aspect, the body of the present disclosure is compliant.

[0338] On the one hand, the body of the present disclosure is adapted to change the shape and / or dimensions of a medical device placed against the construct. Thus, if the medical device is, for example, a graft having a tubular shape that is implanted into, for example, a patient's blood vessel and the body is wound around the exterior of the tubular graft in a helical manner, the body of the present disclosure can increase and / or decrease in size in direct response to a change in the size of the graft. When implanted in a patient, due to changes in intravascular pressure, the size of the graft may change, resulting in an increase (expansion) or decrease (contraction) in the diameter of the graft. Thus, in one embodiment, the body has the ability to return to its normal shape after being stretched or compressed. This property of the body of the present disclosure will be referred to as elasticity, or elastic compliance, and in one aspect, the body of the present disclosure is elastic, or elastically compliant. The construct may alternatively be referred to as elastically deformable.

[0339] On the one hand, the body of the present disclosure undergoes a change in size and / or shape when heated, such as from 25°C to 37°C. This property of the construct of the present disclosure will be referred to as shape memory, and in one aspect, the construct of the present disclosure has shape memory.

[0340] Whether the construct of the present disclosure is compliant, elastic, or has shape memory, or one or more of them, may depend on one or more materials used to manufacture the construct as described below, and / or the shape selected for the body as described above. Figure 7A Shown as being made of such as Figure 1The ring-shaped body 70 made of the wavy filament 71 shown in the figure is in a contracted form and has a diameter 72. As Figure 7B shown, upon radial expansion 73, the body 70 made of the wavy filament 71 assumes an expanded form with a diameter 74. This change in diameter is facilitated by selecting the shape of the body, where as Figure 7A and Figure 7B can be seen, as the body expands to diameter 74, the undulations of the filament 71 become less sharp or less pronounced. In one embodiment, the body of the sensing attachment of the present disclosure has an expandable and contractible shape, such as a ring, clip, clamp, and spring as shown herein.

[0341] On the one hand, the body of the sensing attachment is made entirely or in part of a metal, including metal alloys. Exemplary metals are platinum, an alloy of platinum and iridium, and an alloy of nickel and titanium. On the one hand, the metal is nitinol. Nitinol refers to a superelastic metal alloy of nickel and titanium. In one embodiment, the two elements are present in approximately equal atomic percentages (e.g., Nitinol 55, Nitinol 60). Nitinol exhibits two closely related and unique properties: the shape memory effect (SME) and superelasticity (SE; also known as pseudoelasticity, PE). Shape memory is the ability of nitinol to deform at a certain temperature and then return to its original, undeformed shape when heated above its "transition temperature". Superelasticity occurs in a narrow temperature range just above its transition temperature; in this case, the undeformed shape can be restored without heating, and the material exhibits a huge elasticity, about 10 - 30 times that of ordinary metals. On the one hand, the metal is a non-magnetic alloy of cobalt, chromium, nickel, and molybdenum. This metal alloy is called Elgiloy TM metal alloy and is available from Elgiloy Specialty Metals (Elgin, IL, USA). On the one hand, the metal is an alloy of stainless steel, chromium, nickel, and iron.

[0342] On the one hand, the support of the construct is made entirely or in part of an organic polymer. Exemplary polymers include, but are not limited to, polypropylene, polyethylene, including high-density polyethylene, and polyesters, such as those formed from ethylene glycol and terephthalic acid (e.g., Dacron TM polyester, PET). On the one hand, the organic polymer is an elastomer, such as silicone, polyurethane, polyurethane-siloxane copolymer, and styrene-isoprene rubber (e.g., SIS).

[0343] On the one hand, the body is formed of a circular or oval cross-sectional structure, which can be a solid or tubular base shape, where the material properties are superelastic, the shape, the material, including metals or combinations of metals and polymers, such that the mechanical properties are within a ratio range suitable for processing, handling, and therapeutic management of the human body at 32 °C to 39 °C, and allows for the manufacture of a body with an allowable strain of 8.5% or less to achieve processability and therapeutic deliverability.

[0344] On the one hand, the body of the sensing attachment has a coating covering at least a portion of the body. The term coating is intended to include coatings such as polymer coatings located and adhered to the surface of the sensing attachment, as well as sleeves such as sleeves pulled over the sensing attachment and located around and on top of the surface of the sensing attachment, and modifications to the surface of the sensing attachment that give the surface properties different from those of the underlying material forming the body of the sensing attachment.

[0345] The coating or coatings can impart the desired properties to the body and / or the sensing attachment. On the one hand, the coating enhances the mechanical properties of the body. On the one hand, the coating enhances the electrical properties of the body. On the one hand, the coating enhances the biocompatibility properties of the body. In one embodiment, the sensing attachment can be partially or fully covered in a soft compliant material, woven fabric, polymer, or a combination of these materials to ensure that no mechanical damage occurs when interacting with the stent graft.

[0346] In one embodiment, the coating can serve to reduce wear, which can occur when the sensing attachment changes size in response to changes in the size of the associated implant that the sensing attachment contacts. For example, if the implant is a stent graft, due to the pulsation within the blood vessel where the stent graft is located, its diameter repeatedly increases and decreases, and the sensing attachment expands and contracts in response to this movement of the stent graft, there may be some friction between the graft and the sensing attachment. The graft in the stent graft is typically made of fibers, which can wear when rubbed. On the one hand, the present disclosure provides a sensing attachment with a body having a coating, where the coating is less abrasive to the associated medical device than the underlying material, thereby minimizing the likelihood of wear of the stent graft. The coating can partially or fully cover the body in a soft compliant material, including woven fabric, polymer, or a combination of these materials to ensure that no mechanical damage occurs when interacting with the stent graft.

[0347] On the one hand, the coating is produced by adding a metal element to the surface of the body. Optionally, in this case, the surface has a composition that is a variant of the composition underlying the surface coating, where the coating contains one or more elements not present in the composition underlying the coating. Optionally, the added metal element is present in sufficient quantity and thickness such that the entire coating is made of the additional metal element.

[0348] In one embodiment, the coating is an organic polymer, which includes a single polymer and mixtures of polymers. In one embodiment, the coat or coating is biocompatible. In one embodiment, the coat or coating is non-biodegradable. For example, the coating on the surface of the sensing attachment can be or include poly(tetrafluoroethylene), e.g., Teflon TM polymers. Other suitable coatings can include one or more of epoxy resins, silicones, urethanes, and acrylic resins. A poly(p-xylene) coating, such as that prepared from poly-p-xylene, can also be present on the surface of the sensing attachment.

[0349] The coating can be bonded to the body of the sensing attachment, such as when the coating is produced by adding a metallic element to the body surface or by applying an organic polymer to the body surface, in which case the coating can be referred to as a coating. Optionally, the coating can be a separate feature of the sensing attachment. For example, the coating can be in the form of a sleeve that fits over some or all of the body of the sensing attachment and slides around it. When the sleeve is used to provide a coating over some or all of the body, the sleeve can optionally incorporate passive or active components that act together with the sensor or other components of the sensing attachment. Those components present in or on the sleeve can be fabricated by nano- or microelectromechanical system manufacturing techniques.

[0350] In one embodiment, the coat or coating includes a bioactive agent. The bioactive agent can be released near the attachment to provide a therapeutic benefit to a patient who has received a medical implant. For example, the bioactive agent can be an anti-proliferative drug that causes a reduction in host endothelialization and / or tissue overgrowth, which may accompany the implantation of a medical device and / or sensing attachment. As another example, the bioactive agent can be an anti-fouling agent that protects the surface of the sensing attachment from bacterial deposition.

[0351] In one embodiment, the coat or coating includes chemicals that enhance the lubricity of the coating. For example, the coat or coating can include a lubricating component such as a polyalkylene oxide.

[0352] In one embodiment, the final shape of the support structure is achieved through a process called shape setting. Shape setting is particularly useful when the support structure is formed from a shape memory alloy. After cutting and cleaning the monofilament, the resulting structure is shaped into the desired form, and in the case of a shape memory alloy, subsequent cold working is carried out, mainly in combination with heat treatment, with mechanical means confining all the tines and the base tube within or on a mandrel or fixture of the appropriate geometry. This is referred to as "shape setting".

[0353] The shape of the stylet can be set using different degrees of shape setting / training heat treatments (temperature, time, prior cold work, bending, and bend and free recovery ("BFR") testing), which determine the final mechanical properties, austenite finish, transformation temperature, and alloy composition of the shape memory alloy.

[0354] The sensing attachment will have a size and shape at body temperature, i.e., at or about 37 °C. When no external force is acting on the sensing attachment, this size and shape can be referred to as its natural size and natural shape. The elastic or superelastic sensing attachment can be acted upon by one or more external forces to cause compression or expansion of the sensing attachment. The compressed or constrained state of the sensing attachment occupies less volume than the unconstrained state, where volume refers to the space enclosed within the outer surface of the sensing attachment. For example, the sensing attachment can be compressed to fit within a delivery catheter and constrained to remain in the fitted position within the delivery catheter. When present within the delivery catheter, the sensing attachment can be described as being in a constrained or compressed form or state. At body temperature, when the constraining features of the delivery catheter are removed, or the sensing attachment is ejected from the delivery catheter, the constrained sensing attachment can freely and spontaneously assume its natural or unconstrained or uncompressed form or state.

[0355] This technique of having an article in a constrained state during delivery to a patient and in an unconstrained state after the article has been delivered to the desired location within the patient's body is well known in the field of stent delivery and stent graft delivery, particularly when the delivery is performed percutaneously, i.e., via a needle puncture through the skin. Similar to the procedures used to prepare stents and stent grafts for percutaneous stent and stent graft delivery, in one embodiment of the present disclosure, the sensing attachment is prepared from nitinol, formed into a compressed form during the shaping process, and delivered to the patient's body in the compressed form and assumes a non-compressed form after being delivered to the desired location in the patient. Thus, in one embodiment, the present disclosure provides a method of preparing a sensing attachment in a compressed form from nitinol using shape setting techniques.

[0356] In describing the sensing attachment of the present disclosure, including kits, systems, and methods of making and using the sensing attachment, reference may be made to the diameter of the sensing attachment. Strictly speaking, diameter is only a characteristic of a perfect circle, and the sensing attachment of the present disclosure may not have a perfect circular form. In some embodiments, it may have a non-circular form that can be close to but not equivalent to a circular form. When the sensing attachment is not perfectly circular, a reference to the diameter can be understood as referring to the distance across the sensing attachment as observed from a top view of the sensing attachment, where the graft or stent graft can be located either outside or inside the sensing attachment as viewed from the top view. When the sensing attachment is perfectly circular, then the top view of the sensing attachment will appear as a circle. For example, when the sensing attachment has a shape such as Figure 2BWhen referring to the shape of the cuff bracelet shown, the inner diameter of the sensing attachment refers to the distance between a first point on the inner surface of the cuff bracelet and a second point passing directly through the interior of the sensing attachment, as determined with reference to the first point. As another example, when the sensing attachment has a spring shape as shown in Figure 6 when viewed from the top, it will have a circular appearance, and the inner diameter of the sensing attachment refers to the distance between a first point on the inner surface of the circle and a second point passing directly through the interior of the sensing attachment, as determined by reference to the first point, i.e., if the top view of the spring shows the spring as a perfect circle, it is the standard diameter. For a sensing attachment that does not form a perfect circle when viewed from the top, the inner diameter may alternatively be referred to as the inner cross distance, and the outer diameter may alternatively be referred to as the outer cross distance.

[0357] When the sensing attachment is intended to be located around the outer surface of a medical device and is fixed in place with the help of hoop stress, the inner diameter or inner cross distance of the sensing attachment refers to the minimum distance between the opposing surfaces within the sensing attachment. This minimum distance should be substantially the same and should include only slightly less than the outer diameter of the stent graft or graft so that the sensing attachment exerts a slight force on the medical device. Similarly, when the sensing attachment is intended to be located within the inner surface of a medical device and is fixed in place with the help of hoop stress, the outer diameter or outer cross distance of the sensing attachment refers to the maximum distance between the opposing surfaces of the sensing attachment. This maximum distance should be substantially the same and should include only slightly greater than the inner diameter of the stent graft or graft so that the sensing attachment exerts a slight force on the medical device. The inner cross distance is the inner diameter when the device forms a perfect circle when viewed from the top. The outer cross distance is the outer diameter when the device forms a perfect circle when viewed from the top.

[0358] Regarding the graft and the stent graft, each of them has a lumen, and when the lumen is completely filled with fluid, each has a tubular shape, which is typically the case when the medical device has been deployed in a patient and fluid is flowing through the device. The inner and outer diameters of the graft and the stent graft refer to the state of the device when the fluid is flowing completely through the lumen of the device. In this state, the graft and the stent graft each have an inner diameter (the maximum distance through the lumen) and an outer diameter (the maximum distance between two opposing points on the surface of the graft, as measured through the lumen), where these distances can be observed from the top view of the stent graft or the graft, as if looking down through the lumen.

[0359] In one embodiment, the present disclosure provides a method of associating a sensing attachment with a medical device in a safe manner in vitro. The method includes: selecting a medical device from a graft and a stent graft, wherein the medical device has an inner diameter and an outer diameter; selecting a sensing attachment having an inner diameter (or inner cross distance) and an outer diameter (or outer cross distance), wherein at least one of the following: (i) the inner diameter (or inner cross distance) of the sensing attachment is substantially the same as the outer diameter of the medical device; (ii) the outer diameter (or outer cross distance) of the sensing attachment is substantially the same as the inner diameter of the medical device; and placing the sensing attachment inside or outside the medical device in vitro, wherein circumferential stress secures the sensing attachment to the medical device. The sensing attachment can be selected to have dimensions and a shape that allow it to be securely held near the associated stent graft or graft by circumferential stress. Optionally, when the sensing attachment is a clip, the sensing attachment can be clipped onto the stent graft or graft to associate the sensing attachment with the stent or stent graft.

[0360] In one embodiment, the present disclosure provides a method of manufacturing a system including a medical device having a sensing attachment located therein. The method includes: providing a medical device selected from a graft and a stent graft, the medical device having an inner side (lumen side) and an outer side; determining the inner diameter of the medical device; selecting a sensing attachment having an inner side and an outer side, the outer side having an outer diameter (or outer cross distance), wherein the outer diameter of the sensing attachment is substantially the same as the inner diameter of the medical device; compressing the sensing attachment from a non-compressed state to a compressed state, thereby reducing the inner diameter (or inner cross-section) of the sensing attachment and providing a compressed state of the sensing attachment; placing the compressed sensing attachment at a location within the medical device having an inner diameter; and allowing the sensing attachment to return to the non-compressed state such that the outside of the sensing attachment contacts the inside of the medical device to provide a system including a medical device having a sensing attachment located therein. The sensing attachment can be selected to have dimensions and a shape that allow it to be securely held near the associated stent graft or graft by circumferential stress. Optionally, when the sensing attachment is a clip, the sensing attachment can be clipped onto the stent graft or graft to associate the sensing attachment with the stent or stent graft.

[0361] In one embodiment, the present disclosure provides a method of manufacturing a system including a medical device and a sensing attachment located within the medical device, the method comprising: providing a medical device selected from a graft and a stent graft, the medical device having an inner surface (lumen surface) and an outer surface; selecting a sensing attachment having an inner side and an outer side, the inner side having an inner diameter (or inner cross distance), wherein the inner diameter (or inner cross distance) of the sensing attachment is greater than the outer diameter of the medical device; and placing the sensing attachment around the medical device. The sensing attachment can be selected to have dimensions and a shape that allow it to be securely held in the vicinity of the associated stent graft or graft by circumferential stress. Optionally, when the sensing attachment is a clip, the sensing attachment can be clipped onto the stent graft or graft to associate the sensing attachment with the stent or stent graft.

[0362] In one embodiment, the present disclosure provides a method of associating a sensing attachment with a stent graft in a safe manner in vivo, the method comprising: implanting a stent graft having an outer diameter into a patient's blood vessel during a medical procedure; providing a sensing attachment having an inner diameter (or inner cross distance), wherein the inner diameter (or inner cross distance) of the sensing attachment is substantially the same as the outer diameter of the stent graft; and placing the sensing attachment around the stent graft in vivo during the medical procedure, wherein circumferential stress secures the sensing attachment to the stent graft. The sensing attachment can be selected to have dimensions and a shape that allow it to be securely held in the vicinity of the associated stent graft or graft by circumferential stress.

[0363] In one embodiment, the present disclosure provides a method of associating a sensing attachment with a stent graft in a safe manner in vivo, the method comprising: selecting a stent graft having an outer diameter; implanting the stent graft into a patient's blood vessel during a medical procedure; selecting a sensing attachment having an inner diameter (or inner cross distance), wherein the inner diameter (or inner cross distance) of the sensing attachment is substantially the same as the outer diameter of the stent graft; and placing the sensing attachment around the stent graft in vivo during the medical procedure, wherein circumferential stress secures the sensing attachment to the stent graft. The sensing attachment can be selected to have dimensions and a shape that allow it to be securely held in the vicinity of the associated stent graft or graft by circumferential stress.

[0364] The sensing attachment of the present disclosure includes sensors, i.e., one or more sensors securely attached directly or indirectly to the body of the sensing attachment in a secure manner. The term "sensor" refers to an instrument that can be used to measure one or more different aspects (anatomical, physiological, metabolic, and / or functional) of body tissue and / or one or more aspects of a medical device. Representative examples of sensors suitable for use in the present invention include, for example, fluid pressure sensors, fluid volume sensors, contact sensors, position sensors, pulse pressure sensors, blood volume sensors, blood flow sensors, chemical sensors (e.g., for blood and / or other fluids), metabolic sensors (e.g., for blood and / or other fluids), accelerometers, gyroscopes, displacement sensors, pressure sensors, fluid sensors, mechanical stress sensors, and temperature sensors. Any one or more of these sensors can be included on the sensing attachment. In other embodiments, one or more (including all) of the sensors can have a unique sensor identification number ("USI") that specifically identifies the sensor.

[0365] Sensors can be used to detect, measure, and / or monitor information related to the status of a medical device associated with post-implantation. The status of the medical device can include the integrity of the device, the movement of the device, the forces applied to the device, and other information related to the implanted medical device. Examples of these types of sensors 1022 include pressure sensors, fluid sensors, flow sensors, gyroscopes, accelerometers, displacement sensors, and temperature sensors, as well as other sensors mentioned herein.

[0366] Sensors can be used to detect, measure, and / or monitor information related to the status of the body or body part of a medical device associated with post-implantation. The status of the body or body part can include kinematic information of the body or body part. Examples of these types of sensors 1022 include fluid flow sensors, pressure sensors, gyroscopes, accelerometers, displacement sensors, impedance sensors, and temperature sensors, any one or more of which can be coupled to a processor.

[0367] Sensors can be used to detect, measure, and / or monitor information related to the status of body tissue of a medical device associated with post-implantation. Body tissue monitoring can include blood pressure, pH level, and flow rate. Examples of this type of sensor 1022 include fluid pressure sensors, fluid flow sensors, pulse pressure sensors, blood volume sensors, blood flow sensors, chemical sensors (e.g., for blood and / or other fluids), metabolic sensors (e.g., for blood and / or other fluids).

[0368] Sensors can be used to monitor and / or measure the displacement of a stent graft relative to the blood vessel in which the stent graft is located. For example, the stent graft can have a contact sensor and a sensing attachment placed outside the stent graft can also have a contact sensor, where the two contact sensors sense each other. If the stent graft moves longitudinally, the sensing attachment can resist this movement when the sensing attachment is held relative to the outer surface of the stent graft by circumferential stress (and is also contained in the semi-solid material that is typically present in an aneurysm), or no such movement may occur if the sensing attachment is located around the stent graft but not in physical contact with the surface of the stent graft. This difference in movement can be recorded as a change in contact between the two contact sensors (the contact sensor on the stent graft and the contact sensor on the sensing attachment). This change in contact can be communicated externally to the doctor, who will be aware that the stent graft has moved and can consider taking remedial action.

[0369] In some embodiments, the sensor can be a wireless sensor, or in other embodiments, the sensor is wirelessly connected to a microprocessor. In other embodiments, one or more (including all) sensors can have a unique sensor identification number ("USI") that specifically identifies the sensor and / or a unique device identification number ("UDI"), and the sensor can utilize this identifier to provide unique information for tracking purposes for the relevant medical device for medical device manufacturers, healthcare systems, and regulatory requirements.

[0370] In one embodiment, microelectromechanical systems or "MEMS", or nanoelectromechanical systems or "NEMS", as well as BioMEMS or BioNEMS, see generally https: / / en.wikipedia.org / wiki / MEMS) can be used as sensors in the present invention. Representative patents and patent applications include U.S. Patent Nos. 7,383,071, 7,450,332; 7,463,997, 7,924,267 and 8,634,928, and U.S. Application Publications Nos. 2010 / 0285082 and 2013 / 0215979. Representative publications include "Introduction to BioMEMS", Albert Foch, CRC Press, 2013; From MEMS to Bio-MEMS and Bio-NEMS: Manufacturing Techniques and Applications, by Marc J. Madou, CRC Press 2011; Bio-MEMS: Science and Engineering Perspectives, by Simona Badilescu, CRC Press 2011; "Fundamentals of BioMEMS and Medical Microdevices", Steven S. Saliterman, SPIE - The International Society of Optical Engineering, 2006; "Bio-MEMS: Technologies and Applications", edited by Wanjun Wang and Steven A. Soper, CRC Press, 2012; and "Inertial MEMS: Principles and Practice", Volker Kempe, Cambridge University Press, 2011; Polla, D.L., et al., "Microdevices in Medicine," Ann. Rev. Biomed. Eng. 2000, 02:551 - 576; Yun, K.S., et al., "A Surface-Tension Driven Micropump for Low-voltage and Low-Power Operations," J. Microelectromechanical Sys., 11:5, October 2002, 454 - 461; Yeh, R., et al., “Single Mask, Large Force, and Large Displacement Electrostatic Linear Inchworm Motors,” J. Microelectromechanical Sys., 11:4, August 2002, 330-336; and Loh, N.C., et al., “Sub-10cm3 Interferometric Accelerometer with Nano-g Resolution,” J. Microelectromechanical Sys., 11:3, June 2002, 182-187; all of the above documents are incorporated herein by reference in their entirety.

[0371] In one embodiment, the sensor is a flow sensor. When the sensor is present in a blood vessel of a host, such as in a blood vessel, the flow sensor can be used to measure the flow through the sensor. The flow sensor can be used to detect and / or measure changes in the flow passing through the sensor. The flow sensor may be able to detect an interruption in fluid flow, such as an interruption in blood flow in a blood vessel. The flow sensor may have a single or multiple membranes.

[0372] In one embodiment, the sensor is a pressure sensor. When located within a host, the sensor is capable of measuring pressure and measuring and / or detecting changes in pressure near the sensor. The pressure sensor can be used to measure the pressure present in a blood vessel of a host, such as in a blood vessel. The pressure sensor can be used to detect and / or measure changes in pressure present in a host blood vessel. The pressure sensor may have a single or multiple membranes.

[0373] In one embodiment, the sensor is an ultrasonic sensor that obtains information via an ultrasonic transducer. The ultrasonic transducer can be configured to receive and / or transmit ultrasonic signals. The ultrasonic sensor can be used to measure fluid flow or detect large particulate material, where large refers to the aggregation of more than one red blood cell (RBC), white blood cell (WBC), and / or platelet. In some embodiments, the ultrasonic transducer can be provided with the ultrasonic sensor in an implantable reporting processor to obtain ultrasonic imaging of a desired region of the body, such as a region of the body near an implanted medical device.

[0374] In one embodiment, the sensor is an acoustic sensor. Optionally, the acoustic sensor has a substantially smooth sensitivity between approximately 20 Hz and approximately 20 kHz.

[0375] In one embodiment, the sensor is an IMU, more fully known as an inertial measurement unit. An IMU is an electronic device that uses a combination of accelerometers and gyroscopes to measure and report specific forces, angular rates of the body, and sometimes also the magnetic field around the body.

[0376] The sensor can be associated with one or more other components of the sensing attachment, which may be referred to as auxiliary components, and together these components provide an implantable reporting processor (IRP). Exemplary sensors and auxiliary components can be bundled together and include a sensor, a battery, an inertial measurement unit (IMU); a pedometer, a radio, and an antenna. The components can be welded together and sealed. In one embodiment, the auxiliary components include one or more of a sealed battery, a microprocessor, a memory, and a radio with at least one antenna. The memory may have the ability to store data generated within 1 - 90 days. In one embodiment, the sensor is a wired sensor. In this case, the sensor is connected to a power source, such as a battery, via a wire. Optionally, the wired sensor is a capacitive pressure sensor. In one embodiment, the sensor is a wireless sensor. When the sensor is a wireless sensor, the power source of the sensor is not physically connected to the sensor. The power source can be placed near the sensor, for example, it can be implanted in the abdomen of a patient receiving a graft. The power source can be of the type used to power a pacemaker or an implantable defibrillator, which is a known type of power source. The power source will be physically connected to at least one antenna, which is used to wirelessly transmit power to the sensor. The power source can also be physically connected to an antenna for receiving information from the sensor. Thus, in one embodiment, the present disclosure provides a wireless sensor integrated with a medical device.

[0377] Figure 8 is a diagram of an implantable reporting processor (IRP) 103 that can be associated with a sensing attachment ( Figure 8 not shown). The components of the implantable reporting processor 103 include a power source 112, an electronic assembly 110 having various circuits powered by the power source, and one or more components of a communication interface, such as an antenna 130, electrodes 131, 133, and a sound transducer 135. The circuits of the electronic assembly 110 can include a fuse 114, switches 116, 118, a clock generator and a power management unit 120, one or more sensors 122, a memory 124, a controller 132, and a communication circuit 125. The communication circuit 125 can include one or more of a radio frequency (RF) transceiver 126 and a filter 128 coupled to the antenna 130; a tissue conduction communication circuit 137 coupled to a pair of electrodes 131, 133; or a data sound circuit 139 coupled to the sound transducer 135. Examples of some or all of these components are described elsewhere in this application or in U.S. Application No. 16 / 084,544, which is incorporated herein by reference in all jurisdictions where such incorporation is permitted by reference.

[0378] Reference Figure 8, in the IRP of the sensing attachment, the sensor 122 can be located on the printed circuit board of the electronic assembly 110, or in or on another structure of the sensing attachment, separate from the implantable reporting processor 103, but electrically coupled to the electronic assembly. In certain embodiments, the sensor 122 can include a processor or can be coupled to a processor located on the printed circuit board of the electronic assembly 110. In one embodiment, the sensor is a wireless sensor. In other embodiments, one or more (including all) sensors can have a unique sensor identification number ("USI") that specifically identifies the sensor.

[0379] Reference Figure 8 , the power supply 112 is configured to generate a regulated power signal in the range of approximately 1 - 24 volts (V) to power the components of the implantable reporting processor 103. The power supply 112 can include one or more of a battery, a rechargeable power device (e.g., a rechargeable battery or a supercapacitor), and an energy harvester.

[0380] In one embodiment, the power supply 112 can be any suitable battery, such as a lithium carbon monofluoride (LiCFx) battery, or is configured to store the energy of the power components of the electronic assembly 110 within the expected lifespan of the sensing attachment (e.g., 5 to 25+ years).

[0381] In one embodiment, the power supply 112 can be a rechargeable power device, such as a lithium-ion battery or a supercapacitor. In this case, the power supply 112 includes additional components for charging the power supply through an external recharging unit. These additional components include a power coil configured to generate voltage and current in response to a near magnetic field generated by the external recharging unit.

[0382] In one embodiment, the power supply 112 can be an energy harvester. The energy harvester is configured to convert environmental stimuli into energy for charging a rechargeable power device. For example, the harvester can convert one or more of the body heat of the subject in which the implantable reporting processor 103 is implanted, the kinetic energy generated by the movement of the subject, pressure (e.g., atmospheric pressure or pressure within the subject, such as the subject's blood pressure), the energy generated by electrochemical reactions within the subject, the energy generated by a radio frequency (RF) field, and light into a battery charging current or voltage or a supercapacitor charge.

[0383] Still referring Figure 8 , the fuse 114 can be any suitable fuse (e.g., permanent) or circuit breaker (e.g., resettable) that is configured to prevent the power supply 112 or the current flowing out of the power supply from harming the patient and damaging one or more components of the electronic assembly 110. For example, the fuse 114 can be configured to prevent the power supply 112 from generating heat sufficient to burn the patient, damage the electronic assembly 110, or damage the structural components of the sensing attachment.

[0384] In Figure 8 it, switch 116 is configured to couple power supply 112 to one or more sensors 122 or disconnect power supply from one or more sensors 122 in response to a control signal from controller 132. For example, controller 132 may be configured to generate a control signal having an open state, which causes switch 116 to open and thus disconnect power supply from one or more sensors 122 during a sleep mode or other low power mode to save power and thus extend the life of power supply 112. Similarly, controller 132 may also be configured to generate a control signal having a closed state, which causes switch 116 to close and thus couple power supply to one or more sensors 122 in other cases of "waking up" from the sleep mode or exiting another low power mode. This low power mode may be used only for one or more sensors 122, or for one or more other components of sensor and electronic assembly 110.

[0385] Switch 118 is configured to couple power supply 112 to memory 124 or disconnect power supply from memory 124 in response to a control signal from controller 132. For example, controller 132 may be configured to generate a control signal having an open state, which causes switch 118 to open and thus disconnect power supply from memory 124 during a sleep mode or other low power mode to save power and thus extend the life of power supply 112. Similarly, controller 132 may also be configured to generate a control signal having a closed state, which causes switch 118 to close and thus couple power supply to memory 124 in other cases of "waking up" from the sleep mode or exiting another low power mode. This low power mode may be used only for memory 124, or for one or more other components of memory and electronic assembly 110.

[0386] As Figure 8 shown, clock and power management unit 120 may be configured to generate clock signals for one or more other components of electronic assembly 110, and may be configured to generate periodic commands or other signals (e.g., interrupt requests) in response to which controller 132 causes one or more components of implantable reporting processor 103 to enter or exit a sleep or other low power mode. Clock and power management unit 120 may also be configured to regulate the voltage from power supply 112 and provide a regulated power supply voltage to some or all other components of electronic assembly 110.

[0387] In Figure 8In [the device], the memory 124 may include volatile memory and non-volatile memory. For example, the volatile memory may be configured to store an operating system and one or more application programs executed by the controller 132. The non-volatile memory may be configured to store configuration information of the implantable reporting processor 103 and store data written by the controller 132, and provide data in response to a read command from the controller.

[0388] In one aspect, the implantable reporting processor 103 includes a communication interface that facilitates communication between a sensing attachment ( Figure 8 not shown in [the device]) and another instrument. The other device may be, for example, an external device located outside or away from the patient who has received the sensing attachment, such as a base station, or it may be an internal instrument located within the patient who has received the sensing attachment. In either case, the communication between the implanted sensing attachment and another instrument (whether internal or external) is referred to as in-vivo communication. One or more in-vivo communication modes may be enabled by the communication interface of the implantable reporting processor 103. Possible in-vivo communication modes include: 1) RF telemetry communication, 2) tissue conduction communication, such as electrical coupling communication, and 3) data sound communication, such as ultrasonic or acoustic communication.

[0389] The communication interface includes communication circuitry 125 that is generally but not necessarily associated with the electronic components 110 of the implantable reporting processor 103. The communication circuitry 125 may include any hardware, firmware, software, or any combination thereof suitable for enabling one or more in-vivo communication modes. To this end, the communication circuitry 125 may include, for example, a voltage regulator, a current generator, an oscillator or circuitry for generating signals, resistors, capacitors, inductors, and other filtering circuitry for processing received signals, as well as circuitry for modulating and / or demodulating signals according to a communication protocol.

[0390] Depending on the mode of in-vivo communication, the communication circuitry 125 may also include transistors or other switching circuitry for selectively coupling transmitted signals to a desired transceiver or receiving signals from a desired transceiver, such as the antenna 130 (which may be used for electromagnetic communication, e.g., RF telemetry communication) or electrodes 131, 133 (which may be used for tissue conduction communication) or the acoustic transducer 135 (which may be used for data sound communication). Under the control of the controller 132, the communication circuitry 125 may receive downlink communication signals from an external device or another implanted device, and transmit uplink communication signals to it. Additionally, the communication circuitry 125 may communicate with a networked computing device via an external device and a computer network, such as the Medtronic CareLink(R) network developed by Medtronic, plc of Dublin, Ireland.

[0391] Reference Figure 8, additional details regarding each of the RF telemetry communication, tissue conduction communication, and data acoustic communication modes for in - body communication are as follows.

[0392] In one embodiment, the communication interface includes an RF telemetry mode of in - body communication, which is enabled by an RF communication interface that includes antenna 130 and RF telemetry circuitry, such as RF transceiver 126 and filter 128. The RF transceiver 126 can be a conventional transceiver that is configured to allow the controller 132 (and optionally the fuse 114) to communicate with another implanted medical device ( Figure 8 not shown in the figure) or with a base station configured to be used with a sensing attachment ( Figure 8 not shown in the figure). For example, the RF transceiver 126 can be any suitable type of transceiver (e.g., Bluetooth, Bluetooth Low Energy (BTLE), and ), can be configured to operate according to any suitable protocol (e.g., MICS, ISM, Bluetooth, Bluetooth Low Energy (BTLE), and ), and can be configured to operate in a frequency band from 1 MHz to 5.4 GHz or any other suitable range.

[0393] The filter 128 can be any suitable band - pass filter, such as a surface acoustic wave (SAW) filter or a bulk acoustic wave (BAW) filter. The antenna 130 can be any antenna suitable for the frequency band in which the RF transceiver 126 generates signals for antenna transmission and the frequency band in which the base station ( Figure 8 not shown in the figure) generates signals for antenna reception.

[0394] In one embodiment, the communication interface includes a tissue conduction communication (TCC) mode of in - body communication, which is enabled by a TCC interface that includes TCC circuitry 137 and a pair of electrodes 131, 133. The TCC interface allows the controller 132 to communicate with another device having the same TCC interface as the implantable reporting processor 103. The other device can be an implanted medical device ( Figure 8 not shown in the figure), or a base station configured to be used with a sensing attachment ( Figure 8 not shown in the figure) ( Figure 8 not shown in the figure).

[0395] Tissue conduction communication relies on the ionic content of the patient's body tissue in which the sensing attachment is implanted and is thus commonly referred to as current communication. The ionic content of the body tissue provides an electrical communication medium through which information is sent to and received from the sensing attachment. To communicate in the transmit mode, the TCC circuitry 137 applies a voltage across the electrodes 131, 1033 to cause a current to flow between the electrodes and the corresponding electrical signal to propagate through the body tissue. By measuring the voltage generated between the two electrodes, the receiving device ( Figure 8(not shown) can detect the propagation current. To communicate in the receive mode, the TCC circuit 137 measures the voltage across the electrodes 131, 133.

[0396] When tissue conduction communication is employed to facilitate communication, the sensing attachment and other devices that receive information and / or send information to the sensing attachment have relevant hardware, firmware, software, or any combination thereof suitable for providing such communication. TCC transmission and the associated hardware, firmware, software have been described and may be included in the intelligent implantable devices of the present disclosure. See, for example, U.S. Patent Publications No. US2016213939, No. US2018207429, No. US2019160290, No. US2019160291, No. US2019160292, No. US2019184181. For example, in one aspect, the TCC circuit 137 may be coupled to one or more electrodes 131, 133 and configured with circuitry that enables the TTC interface to switch between a transmit mode for transmitting a TCC signal and a receive mode for receiving a TCC signal from another similarly configured device.

[0397] In one embodiment, the communication interface includes a data sound mode of in-vivo communication enabled by a data sound communication interface that includes a data sound circuit 139 and at least one acoustic transducer 135. The data sound communication interface allows the controller 132 to communicate with another instrument having the same data sound communication interface as the implantable reporting processor 103. The other instrument may be an implantable medical device ( Figure 8 (not shown), or a base station ( Figure 8 (not shown) configured to be used with the sensing attachment ( Figure 8 (not shown).

[0398] Data sound communication relies on the patient's body in which the sensing attachment has been implanted to provide a medium through which information is sent to and received from the implanted sensing attachment. To communicate in the transmit mode, the data sound circuit 139 outputs mechanical sound waves that propagate through the body via the acoustic transducer 135. The sound waves may be in the ultrasonic range, for example, above 20 KHz. The propagated mechanical sound waves may be detected by a receiving device having an acoustic transducer ( Figure 8 (not shown). To communicate in the receive mode, the data sound circuit 139 receives and measures the sound waves.

[0399] When data-sound communication is employed to facilitate communication, the implanted sensing accessory 1002 and other devices that receive information and / or send information to the implanted sensing accessory have relevant hardware, firmware, software, or any combination thereof suitable for providing such communication. Data-sound communication transmissions and the associated hardware, firmware, and software have been described and may be included in the sensing accessory of the present disclosure. See, for example, U.S. Patent No. 7,489,967 and U.S. Patent Publications Nos. 2010 / 0249882 and 2013 / 0033966. For example, in one aspect, a data-sound circuit 139 may be coupled to a sound transducer 135 and configured with circuitry enabling a data-sound communication interface to switch between a transmission mode for transmitting ultrasonic signals and a reception mode for receiving ultrasonic signals from another similarly configured device.

[0400] Referring Figure 8 , a controller 132, which may be any suitable microcontroller or microprocessor, is configured to control the configuration and operation of one or more other components of the electronic assembly 110. For example, the controller 132 is configured to control one or more sensors 122 to sense relevant measurement data and store the measurement data generated by the one or more sensors in a memory component. The controller 132 is also configured to generate messages for communication via one or more types of communication interfaces. For example, in the case of RF telemetry communication, the controller 132 generates a message including the stored data as a payload, packs the message, and provides the message packet to an RF transceiver 126 for transmission to a base station ( Figure 8 not shown). The controller 132 may also be configured to execute commands received via the communication interface from a base station ( Figure 8 not shown), such as an antenna 130, a filter 128, and an RF transceiver 126. For example, the controller 132 may be configured to receive configuration data from a base station and provide the configuration data to the components of the electronic assembly 110 to which the configuration data is directed. If the base station directs configuration data to the controller 132, the controller is configured to configure itself in response to the configuration data.

[0401] Still referring Figure 8 , the operation of an implantable report processor (IRP) 1003 is described as being related to the implanted sensing accessory, where the IRP is provided or otherwise associated therewith.

[0402] The normally electrically closed fuse 114 is configured to open electrically in response to an event that could harm the patient in which the implantable reporting processor 103 is located, or that could damage the power supply 112 of the implantable circuitry if the event persists for longer than a safe length of time. Events in response to which the fuse 114 can open electrically include overcurrent conditions, overvoltage conditions, overtemperature conditions, overcurrent time conditions, overvoltage time conditions, and overtemperature time conditions. An overcurrent condition occurs in response to the current through the fuse 114 exceeding an overcurrent threshold. Similarly, an overvoltage condition occurs in response to the voltage across the fuse 114 exceeding an overvoltage threshold, and an overtemperature condition occurs in response to the temperature of the fuse exceeding a temperature threshold. An overcurrent time condition occurs in response to the integration of the current through the fuse 114 over a measurement time window (e.g., ten seconds) that exceeds a current time threshold, where the window can "slide" forward in time such that the window always extends backward from the current time by the length of the window, in units of time. Optionally, an overcurrent time condition occurs if the time that the current through the fuse 114 exceeds the overcurrent threshold exceeds a threshold time. Similarly, an overvoltage time condition occurs in response to the integration of the voltage across the fuse 114 over a measurement time window, and an overtemperature time condition occurs in response to the integration of the temperature of the fuse over a measurement time window. Optionally, an overvoltage time condition occurs if the time that the voltage across the fuse 114 exceeds the overvoltage threshold exceeds a threshold time, and an overtemperature time condition occurs if the time that the temperature associated with the fuse 114, the power supply 112, or the electronic assembly 110 exceeds the temperature threshold exceeds a threshold time. However, even if the fuse 114 opens, thereby disconnecting the power supply from the electronic assembly 110, the mechanical and structural components of the intelligent implant ( Figure 8 not shown) remain fully operational.

[0403] The controller 132 is configured to cause one or more sensors 122 to make a detection or measurement, such as a pressure or fluid flow detection or measurement, to determine whether the measurement is a qualified or valid measurement, to store data representative of the valid measurement, and to cause the RF transceiver 126 to transmit the stored data to a base station or other source external to the prosthesis.

[0404] Still referring Figure 8 , in response to being polled by a base station ( Figure 8 not shown) or by another instrument external to the implanted device, the controller 132 generates a regular message having a payload and header information. The payload includes stored samples of signals generated by one or more sensors 122, and the header information includes a partition of the samples in the payload, a timestamp indicating the time at which the sensors 122 acquired the samples, an implantable prosthesis identifier (serial number), and a patient identifier (e.g., number or name).

[0405] The controller 132 generates data packets including messages according to a conventional data packet protocol. Each packet may also include a packet header that includes, for example, the sequence number of the packet, so that even if the packets are sent or received out of order, the receiving device can correctly sort the packets.

[0406] The controller 132 encrypts some or all parts of each data packet according to a conventional encryption algorithm, for example, and performs error coding on the encrypted data packets. For example, the controller 132 encrypts at least the sensing attachment and the patient identifier to make the data packets compliant with the Health Insurance Portability and Accountability Act (HIPAA).

[0407] The controller 132 provides the encrypted and error-coded data packets to the RF transceiver 126, and the RF transceiver 126 sends the data packets to a destination outside the sensing attachment via the filter 128 and the antenna 130, such as the home base station 104. The RF transceiver 126 can transmit the data packets according to any suitable data packet transmission protocol.

[0408] Still referring Figure 8 to, alternative embodiments of the implantable report processor 103 are envisioned. For example, the RF transceiver can perform encryption or error coding instead of or complementary to the controller 132. In addition, one or both of the switches 116 and 118 can be omitted from the electronic assembly 110. In addition, the implantable report processor 103 can include components other than those described herein, and one or more of the components described herein can be omitted.

[0409] In certain embodiments of the present invention, the sensing attachment has a specific unique device identification number ("UDI"), and in other embodiments, each sensor on the sensing attachment has a specific unique sensor identification number ("USI"), or a unique group identification number ("UGI", for example, an identification number that identifies the sensor as one of a group of sensors, such as 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, and / or a mechanical stress sensor). In other embodiments, the USI is specifically associated with a location on the sensing attachment.

[0410] In one embodiment, the sensor is directly or indirectly attached to the body of the sensing attachment. For example, the sensor can be contained within a housing, where the housing is fixed in place on the body, thereby fixing the sensor in place on the sensing attachment. In one embodiment, the housing is not an airtight sealed housing. In one embodiment, the housing is an airtight sealed housing that does not interfere with the operation of the sensor and auxiliary components.

[0411] Figure 9AA method for attaching a sensor to a support in the form of a filament according to the present disclosure is shown. In Figure 9A , the sensor housing 150 is shown to have two extensions 152, each extension 152 having a hole. A support filament 154 of a wire strut support such as Figure 1 , Figure 2A , Figure 2B , Figure 2C, Figure 3A , Figure 3B , Figure 4B , Figure 5A or Figure 5B shown in is helically threaded through the holes in the extensions. The holes are filled by the wire strut 154, but the positions of the holes are shown as features 156. In this way, the sensor housing, and depending on the sensor itself, is attached to the support to provide the configuration of the subject and sensor of the present disclosure.

[0412] Figure 9B Another method for attaching a sensor to a support according to the present disclosure is shown. In Figure 9B , the sensor housing 160 is shown to have two extensions 162a and 162b, each extension 162a and 162b having two holes. A support wire 164 of a wire strut support such as Figure 1 , Figure 2A , Figure 2B , Figure 2C, Figure 3A , Figure 3B , Figure 4B , Figure 5A or Figure 5B shown in is helically threaded through one hole in each extension, for example hole 166a in extension 162a and hole 166b in extension 166b, while another wire strut 164 is helically threaded through hole 168a in extension 162a and hole 168b in extension 166b. In this way, the sensor housing, and depending on the sensor itself, is attached to the support to provide the configuration of the subject and sensor of the present disclosure.

[0413] Figure 9C Yet another method for attaching a sensor to a support according to the present disclosure is shown. In Figure 9C , the sensor housing 170 is shown to have one extension 172, where the extension 172 has a hole 174. A support such as Figure 1 , Figure 2A , Figure 2B , Figure 2C, Figure 3A , Figure 3B , Figure 4B , Figure 5A or Figure 5BOne support monofilament 176 of the wire strut support shown in [figure number] helically passes through the hole 174 in the extension. In this way, the sensor housing, and depending on the sensor itself, is attached to the support to provide the construction of the main body and the sensor of the present disclosure.

[0414] Figure 9D Another method for attaching a sensor to a support according to the present disclosure is shown. In Figure 9D , the sensor housing 180 is shown to have an extension 182, where the extension 182 has a hole 184. It can be a support monofilament 186 such as that of the wire strut support shown in Figure 1 , Figure 2A , Figure 2B , Figure 2C, Figure 3A , Figure 3B , Figure 4B , Figure 5A or Figure 5B helically passes through the hole 184 in the extension. Additionally, a crimp is applied at positions 188 on either side of the extension 182, where the crimp helps attach the sensor to the monofilament support at a fixed position. In this way, the sensor housing, and depending on the sensor itself, is attached to the support to provide the construction of the main body and the sensor of the present disclosure.

[0415] Figure 10 , Figure 11 and Figure 12 show constructs in which the sensor within the main body and the housing have been combined. Although the sensor can be contained within a housing such as that shown in Figure 9A , Figure 9B , Figure 9D and Figure 9D , the sensor can alternatively be combined with the main body using other fixing techniques, such as chip stacking and bonding attachment consisting of low temperature or non-destructive temperature processes. Environmental humidity, supersaturated humidity, or non-humidity bonding processes can also be employed to fix the sensor to the main body of the sensing attachment.

[0416] Figure 10Illustrated is a construct 200 including support struts 220 in the form of wire loops, on which a plurality of sensors 210 are located. The construct 200 may be referred to herein as CSR2. The CRS2 includes wireless capacitive pressure sensors and may also include accelerometers if used inside a stent graft. The sensors are mounted on at least one sinusoidal strut 220, which can expand to conform to the available endovascular geometry. The construct 200 can be fixed around the stent graft via circumferential stress against the abutting surface. The construct 200 thus abuts and remains in place next to the medical device without being mechanically attached to the medical device. The shape and size of the sensors are preferably minimized to provide a minimum cross-sectional area for blood flow, thereby reducing the risk of hemolysis and thrombosis. The construct may include a plurality of struts 220 to provide additional stability for the orientation of the sensors and / or provide additional compression of the lumen of the inner graft or arterial vessel. The latter may be necessary to prevent migration of the CRS2 when subjected to forces within the vascular system. Each CRS2 is designed to cover a minimum and maximum inflation range to cover a certain range of vessel diameters. For example, one CRS2 can cover a diameter of 3 mm to 6 mm, and the next larger size can cover 5 mm to 10 mm. Such schemes can be used to cover the vessel lumen diameters commonly found in the cardiovascular system or aneurysm geometries.

[0417] Figure 11 is another view of construct 230, which includes wire strut supports 240, to which a plurality of sensors 210 are attached.

[0418] Figure 12 is from Figure 11 an enlarged view of a portion 4 of the wire of support 240, to which sensor 210 is attached.

[0419] The sensors can be attached to each rail at a single point or multiple points via interconnect holes integrated into the sensor housing ( Figure 10 ), and / or welded or glued in place. Optionally, they can be fixed in place by crimping, gluing or other attachment stops that hold the sensors in place along the stent rails ( Figure 11 ).

[0420] As described herein, the placement of the sensors on the body should not interfere with the body's ability to be compliant, elastic, or have shape memory, or any combination thereof.

[0421] Figure 13A and Figure 13B illustrates as Figure 7AThe body 70 shown, to which the sensor 210 is attached to provide the construct 250. The construct 250 may include a rail in a compressed geometry 252 or an extended geometry 254, where in each case, the rail is attached to a plurality of sensors 210. The extended form is useful if a laparoscopic or open surgical method is used in which the CRS2 is placed outside the blood vessel / catheter, otherwise the CRS2 may be in an open or compact configuration for mounting around the blood vessel. In this case, an external fixing device such as a clip, adhesive, or other crimping techniques known to those skilled in the art can be used to keep the loop open or compressed to form a closed loop.

[0422] If the body has a portion whose size or shape does not change significantly during use, the sensor and auxiliary components can be attached to that portion of the body. For example, as Figure 14 shown, Figure 6 the body shown has a spline 300 (shown as feature 63 in Figure 6 ) that remains at a constant size during use. Sensors 302 (three sensors 302 are shown in Figure 14 ) can be placed on the spline 300, which can communicate wired via line 304. A power supply 306 can likewise be fixed to the spline 300 to supply power to the sensors 302 via line 308. Figure 14 An antenna 310 is also shown in

[0423] to provide communication between the outside world and the implanted sensing attachment. The antenna 310 can communicate wired with the sensors 302 and / or the power supply 306 via a line conduit 312. The antenna 310 can be fixed to the spline 300 on the longitudinal and / or radial axes, or it can be attached only to the line 312, in which case the antenna can move freely away from the sensor attachment. The attachment can be done, for example, by welding or gluing.The body can be manufactured by standard methods known in the art. For example, methods for manufacturing an object from nitinol are well known and can be used to manufacture the body of the present disclosure. For example, a hollow monofilament made of nitinol can be cut multiple times to provide a body including a plurality of incisions. The body can be fixed to a mandrel to cause it to adopt the desired shape and dimensions, which are the final desired shape and dimensions when the sensing attachment is associated with a medical device. When attached to the mandrel, the body is placed at a high temperature, such as 550 °C for a period of time, then cooled, and then the mandrel is removed, whereupon the body retains the dimensions and shape it had when fixed to the mandrel, herein referred to as its natural state. The body can then be cooled, typically referred to as supercooling, and compressed into a smaller volume state, i.e., a compressed state. When this compressed state of the body is brought to room temperature of about 25 °C, it will retain its compressed state. However, when it is further heated to body temperature of about 37 °C, it will spontaneously decompress and return to its natural state. When the body, which is part of the sensing attachment, is placed within a delivery catheter, the compressed state can be further compressed, where this further compression is sometimes referred to as crimping. After release from the delivery catheter at body temperature of about 37 °C, the sensing attachment will decompress and enter its natural state. This or similar techniques can be used for other metal bodies, such as those prepared from platinum or an alloy of platinum and iridium.

[0424] In one embodiment, the sensing attachment is associated with, or incorporated into, or is intended to be associated with a medical device. The medical device of the present disclosure is a graft or a stent graft. Representative stent grafts with which the sensing attachment of the present disclosure can be associated include vascular (e.g., endovascular) stent grafts, gastrointestinal (e.g., esophageal) stent grafts, and urinary stent grafts. A stent graft is a tube made of a thin metal mesh (the stent) covered with a thin fabric (the graft).

[0425] Unless the context otherwise indicates, a reference to a graft does not refer to a stent graft, but rather to a graft without a stent. A graft is a tubular structure having a lumen and a surrounding wall, where the wall can be referred to as a sidewall. The wall has an inner surface facing the lumen, i.e., an extroluminal surface, and also has an outer surface or an external surface facing away from the lumen, i.e., an extroluminal surface. In one embodiment, the graft is a vascular graft. In one embodiment, the graft can be made of a synthetic material, such as a polyester fabric. Expanded polytetrafluoroethylene, Or other polyethylene terephthalate and polyurethane are currently used to manufacture synthetic vascular grafts and can be used to manufacture the grafts of the present disclosure. In one embodiment, the graft has only two holes: a hole allowing fluid to enter the graft and a hole allowing fluid to leave the graft, wherein the graft provides a conduit for the fluid. When the graft is intended for vascular transplantation, i.e., a synthetic vascular graft, in one embodiment, the graft has a diameter greater than 8 mm, such as 8 to 10 mm, and can be used for, for example, aortoiliac artery replacement, or can have a diameter of about 6 to 8 mm and can be used for, for example, carotid artery or common femoral artery replacement.

[0426] In one embodiment, the medical device is suitable for endovascular treatment or repair. For example, a graft or a stent graft can be suitable for treating or repairing an endovascular aneurysm. Generally, an aneurysm is a bulge and weakness in the aortic wall, but it can occur anywhere in the human arterial vascular system. The aorta is the largest blood vessel in the body and it transports blood from the heart to other parts of the body. Most aortic aneurysms occur in the abdominal aorta (abdominal aortic aneurysm or AAA), but they can also occur in the thoracic aorta (thoracic aortic aneurysm or TAA) or in the thoracic and abdominal segments of the aorta. Other examples of aneurysms that can be treated or repaired with the stent grafts of the present disclosure include femoral aneurysms, which are bulges and weaknesses in the femoral artery wall (located in the thigh), an iliac aneurysm that is a weakness in the wall of the iliac artery (a group of arteries located in the pelvis), a popliteal aneurysm that occurs when there is a weakness in the wall of the popliteal artery that supplies blood to the knee, thigh, and calf, a subclavian aneurysm that occurs at a weakness or bulge in the wall of the subclavian artery (located below the collarbone), a suprarenal aneurysm of the aorta above the kidneys, and a visceral aneurysm that occurs within the celiac artery and includes the celiac artery, superior mesenteric artery, inferior mesenteric artery, hepatic artery, splenic artery, and renal artery.

[0427] For example, a stent graft can be used to treat or repair an abdominal aortic aneurysm (AAA), and in this case, such a device is sometimes referred to as an endovascular repair graft for AAA. Endovascular repair can be performed to treat aneurysms located below the renal arteries. Using a needle puncture or a small incision in one or both of the patient's groin arteries, a thin tube (catheter) is inserted and advanced to the aneurysm site, usually guided by X-ray images. Then a wire and an expandable stent graft (a fabric-covered wire frame) are advanced through the thin tube. Once in the correct position, the stent graft is allowed to expand within the artery. The wire frame pushes against the healthy part of the aorta to seal the device in place. Once in place, blood flows through the stent graft and cannot enter the aneurysm. This procedure can be performed efficiently, taking 1.5 to 3.5 hours, and most patients are discharged within 1 to 5 days.

[0428] In some cases, an aneurysm affects one or more major arteries branching off the aorta. In such cases, different types of grafts, called fenestrated grafts or fenestrated stent grafts, are placed. Fenestrated grafts get their name from the tiny incisions that allow the graft to bend and align with the artery branches and can also be modified to fit your specific anatomy. Implantation of a fenestrated graft typically takes 3 - 8 hours. As used herein, a stent graft refers to a fenestrated graft as well as a graft that does not contain tiny incisions. In one embodiment, the medical device is suitable for treating or repairing an abdominal aortic aneurysm (AAA).

[0429] As another example, a stent graft can be used to treat or repair a thoracic aortic aneurysm (TAA). The procedure for repairing a TAA with a stent graft is commonly referred to as thoracic endovascular aneurysm repair (TEVAR). Thoracic aortic aneurysms are classified into three categories based on their location: aortic arch, ascending aorta, and descending thoracic aneurysms. A TAA can be a thoracoabdominal aortic aneurysm, which is a bulge and weakness in the aortic wall that extends from the chest into the abdomen. Using a surgical method, the thoracic aneurysm is replaced with a synthetic graft. In the TEVAR procedure, the thoracic stent graft is inserted into the aneurysm through a small incision in the groin. In one embodiment, the medical device of the present disclosure is suitable for treating or repairing a thoracic aortic aneurysm (AAA). In one embodiment, the medical device is a stent graft for TEVAR. In another embodiment, the medical device is a graft for the surgical treatment of a TAA as described above.

[0430] Exemplary grafts and stent grafts suitable for use as medical devices according to the present disclosure are provided in CN105832332; CN107440816; CN202207217U; CN204049932U; CN207085001U; GB201517623; GB201519983; GB2515731; GB2517689; RE39,335; US20100324650; US20120239131; US20120271399; US20130073027; US20130261731; US20140018902; US20140052231; US20140121761; US20140135898; US20140277335; US20150088244; US20150127086; US20150202065; US20150250626; US20150250629; US20150335290; US20160038085; US20160100969; US20160113796; US20160120638; US20160184076; US20160184077; US20160184078; US20160250395; US20160302950; US20170000630; US20170007391; US20170135806; US20170209254; US20170231749; US20170231751; US20170239035; US20170281331; US20170281332; US20170290654; US20170319359; US20170340462; US20170360993; US20180071076; US7,290,494; US8,118,856; US8,728,145; US8,870,938; US8,888,837; US8,945,200; US8,945,203; US8,951,298; US8,998,972; US9,101,457; US9,168,162; US9,345,594; US9,468,517; US9,486,341; US9,603,697; US9,629,705; US9,687,366; US9,808,334; US9,811,613; US9,833,341; US9,839,540; US9,861,503; US9,907,642; US9,918,825; US9,925,032;In WO11158045; WO13130390; WO15047094; WO16123676; WO17060738; WO17064484; WO2013167491; WO2013167492; WO2013167493; WO2016008944; WO2017114879; WO2017134198; and WO2017187174.;

[0431] For endovascular stent graft implantation, a surgeon inserts a stent graft into a blood vessel at the aneurysm location to reduce the pressure on the blood vessel wall at the aneurysm site. Such stent grafts have been widely used for many years and are well known. Unfortunately, such endovascular stent grafts sometimes fail. One type of failure that can occur is blood seeping into the aneurysm sac; a condition called endoleak, of which there are 5 different types. Type I endoleak occurs when blood flows between the stent graft and the blood vessel wall; usually at the proximal (usually renal) or distal (usually iliac) end of the graft. This complication can also occur due to movement of the graft away from its desired position, sometimes called migration. Type II endoleak occurs when blood flows backward (retrograde) from an artery that originates from the aneurysm sac itself (usually the lumbar, testicular, or inferior mesenteric artery) into the aneurysm sac. Type III endoleak occurs when blood leaks between the connection sites of an "articulated" or "segmented" stent graft; these multi-component stent grafts are inserted as separate parts and then assembled into their final configuration within the artery. Detecting and confirming accurate assembly and fluid-tight contact between the different parts is difficult, and current verification methods for correct assembly are suboptimal. Type IV endoleak occurs when cracks or defects appear in the stent graft fabric and blood can leak directly through the graft material. Finally, type V endoleak is blood leaking into the aneurysm sac from an unknown source. Regardless of its cause, endoleak is generally a medical emergency, and early detection, characterization, and monitoring of them are an important unmet medical need.

[0432] Other complications of stent graft placement include partial blockage (stenosis) of the blood flowing through the stent graft, detachment, rupture, fabric wear (durability), kinking, misalignment, and systemic cardiovascular conditions (myocardial infarction, congestive heart failure, arrhythmia, renal failure). Currently, it is difficult or, in many cases, impossible to detect such complications before they occur or in the early stages of their development. The present disclosure addresses these problems by associating sensing attachments with conventional implanted stent grafts or conventional implanted grafts.

[0433] On the one hand, the medical device is an implantable medical device, and an exemplary implantable medical device is a stent graft, which is implanted into a patient's body during a surgical procedure to treat an aneurysm. An aneurysm refers to an undesired dilation of a blood vessel, for example, a dilation that exceeds at least 1.5 times the normal diameter of the blood vessel. The dilated blood vessel may have a bulge called an aneurysm sac, which can weaken the blood vessel wall and eventually rupture. Aneurysms are most commonly found in the arteries at the base of the brain (i.e., the circle of Willis) and the largest artery in the human body, the aorta. The abdominal aorta from the diaphragm to the bifurcation of the main iliac arteries is the most common site for aortic aneurysms. This abdominal aortic aneurysm (AAA) usually occurs between the renal artery and the iliac artery.

[0434] The sensing attachment can be associated at different locations of the stent graft, as in the example shown in Figures 15 to 18 . For illustrative purposes, in Figures 15 to 18 , the sensing attachment is shown associated with an AAA stent graft. However, the sensing attachment can equally be associated with different stent grafts, for example, different (non-AAA) vascular (e.g., endovascular) stent grafts, gastrointestinal (e.g., esophageal) stent grafts, or urinary stent grafts. Similarly, the sensing attachment can be associated with a graft rather than a stent graft. When associated with a graft, the sensing attachment can be within the lumen, i.e., the outer lumen, i.e., associated inside the graft.

[0435] As shown in Figure 15 , as previously shown in Figure 7A and Figure 7B , a sensing attachment 410 in the form of a filament as shown in

[0436] can be deployed within the aneurysm sac 412 of the blood vessel 414 and in contact with the outer surface of the inner graft 416. Figure 16 As shown in Figure 3A , a sensing attachment 420 in the form of a clip as shown in Figure 16 can be deployed at the entrance of the aneurysm sac 412 of the blood vessel 414 and in contact with the inner and outer surfaces of the inner graft 116. Also as shown in Figure 4A , a sensing attachment 422 in the form of a clip as shown in Figure 16contact as shown in). In one embodiment, the sensing attachment includes a pressure sensor, which refers to one or more pressure sensors. The pressure sensors can have a preferred orientation depending on how they are placed. A sensing attachment designed to contact a lumen (blood vessel or synthetic graft) will orient the pressure sensor radially inward away from the lumen. A sensing attachment in the form of a ring can also be placed outside and juxtaposed to an endovascular graft as a ring. In this case, the circumferential stress of the endovascular graft will contact the inner diameter of the sensing attachment and hold it in place. In this case, the sensor will be oriented radially outward.

[0437] As Figure 17 shown in, as Figure 5A and Figure 5C shown in, a sensing attachment 430 in the form of a spring can be deployed within the aneurysm sac 412 of a blood vessel 414 and contact the outer surface of the endograft 416.

[0438] As Figure 18 shown in, as Figure 6 shown in, a sensing attachment 440 in the form of a spring can be deployed within the aneurysm sac 412 of a blood vessel 414 and contact the outer surface of the endograft 416.

[0439] In addition to long-term monitoring of hemodynamic and other parameters, the sensing attachments described herein also offer the advantage of being universal to any endovascular graft and can be percutaneously assembled onto the graft during surgery, either extracorporeally or intracorporeally, without affecting the design of the graft.

[0440] Optionally, the sensing attachment can be located within the aneurysm sac such that it neither contacts (nor minimally contacts) the endovascular graft nor significantly contacts the inner lumen of the aneurysm sac. This option is shown in Figure 19 . Once the endovascular graft 416 is deployed within the blood vessel 414, due to the arterial proximal and distal sealing of the endograft relative to the aneurysm sac, the sensing attachment 450 including the sensor 452 is captured within the aneurysm sac 412. In one embodiment, the sensing attachment surrounds the length of the stent graft but has an uncompressed dimension with an inner diameter greater than the outer diameter of the stent graft. In this way, the sensing attachment effectively floats within the aneurysm sac rather than pressing against the surface of the stent graft and being held in place by circumferential stress.

[0441] In one embodiment, Figure 19The sensing attachment in the depicted scenario includes a plurality of sensors, each of which has a controlled orientation relative to the stent graft. Since the sensing attachment extends completely around the stent graft and the stent graft is in fixed contact with the blood vessels above and below the aneurysm sac, the sensing attachment within the aneurysm sac cannot be flipped or inverted: it must maintain a fixed orientation relative to the stent graft. Because the relative orientation of the stent graft and the sensing attachment is fixed and because the sensors maintain a fixed orientation on the sensing attachment, the sensors have a constant, controlled, and known orientation relative to the stent graft.

[0442] In one embodiment, the present disclosure provides a system including a stent graft and a sensing attachment, where the stent graft has an outer diameter determined in the uncompressed state of the stent graft and the sensing attachment has an inner diameter determined in the non-compressed and non-expanded state of the sensing attachment, where the inner diameter of the sensing attachment is greater than the outer diameter of the stent graft such that the sensing attachment fits around the outer surface of the stent graft without contacting the outer surface of the stent graft. The sensing attachment has a plurality of sensors that are in a fixed orientation relative to the body of the sensing attachment, where the sensors can be, for example, pressure sensors or flow sensors. In one embodiment, the present disclosure provides a method where the system is implanted into a patient, where the stent graft traverses the aneurysm sac and the sensing attachment surrounds the outside of the stent graft and is located within the aneurysm sac, as Figure 19 shown.

[0443] In Figure 15 and Figure 19 the sensing attachment is shown as having sensor 103. For ease of viewing, the sensors are not shown in Figure 16 , Figure 17 and Figure 18 . However, when the sensing attachment is associated with the implanted stent graft, as shown in Figure 16 , Figure 17 and Figure 18 , the sensing attachment will have at least one sensor as discussed herein. Moreover, an exemplary sensing attachment placed inside the AAA graft, i.e., within the lumen, is shown in Figure 16 , where the sensing attachment 122 is completely within the stent graft at the distal location and the sensing attachment 120 is partially placed within the lumen and partially outside the lumen, i.e., on the outer surface of the stent graft, at the proximal location, where blood flows from the proximal end to the distal end of the stent graft. Although Figure 15 , Figure 17 and Figure 18 show the sensing attachment completely on the outer lumen surface of the stent graft, the sensing attachment can alternatively be located on the inner lumen surface of the stent graft. Moreover, although Figure 15 , Figure 17 and Figure 18Shows a sensing attachment within the aneurysm sac around the center or body of the stent graft, but the sensing attachment can alternatively be located at the proximal and / or distal ends of the stent graft.

[0444] In an alternative embodiment, a sensing attachment having a wireless accelerometer and a wireless capacitive pressure sensor can be used in combination with a sensing attachment external to the endograft located within the aneurysm sac to obtain intraluminal pressure measurements within the aneurysm sac region and within the blood vessel. The pressure within the aneurysm sac will be much lower than that in the blood vessel as it has been excluded from flow by the endograft. The pressure within the aneurysm sac well sealed by the endograft is typically in the range of 10 - 30 mmHg with a pulse pressure of 5 - 10 mmHg, as compared to an arterial pressure of 60 - 140 mmHg with a pulse pressure of 40 - 60 mmHg. If there is an endoleak, the aneurysm sac pressure will increase, resulting in a decrease in the mean intraluminal pressure and pulse pressure. This in turn will cause segmental changes in the graft wall motion, resulting in changes in the accelerometer signal. In addition to changes in the intraluminal pressure, having an accelerometer signal will prevent false positive indications of pressure sensor drift indicating EL as two sensors (accelerometer and pressure) are required to diagnose the presence of an endoleak.

[0445] For coronary applications, sensing attachments will be implanted proximal and distal to the lesion, avoiding any contact with the actual coronary stent. By measuring the pressure at each location, detailed information regarding coronary vessel flow rate, pressure, and pulse pressure changes over time can be monitored, alerting patients and clinicians to changes with higher fidelity compared to discrete monitoring every six months to one year as the standard of care.

[0446] In the case of an implantable medical device, the sensing attachment can be associated with the medical device before implantation, i.e., pre - operatively, or during implantation, i.e., intra - operatively, or after the implantable medical device has been implanted in the patient, i.e., post - operatively.

[0447] On the one hand, the sensing attachment is associated with the medical device prior to the procedure of implanting the medical device into the patient, i.e., pre - operatively. In one embodiment, the sensing attachment is associated with the medical device in the operating room but before the start of the surgery. In one embodiment, the sensing attachment is associated with the medical device before the medical device is packaged for shipment to the surgical center such that the sensing attachment is already associated with the medical device when it arrives in the operating room.

[0448] In one embodiment, a sensing attachment is associated with a graft. The graft is typically implanted into a patient during surgery, where the graft is interposed, i.e., a portion of a tubular structure in the patient is excised, and the graft is interposed at the location where the tube was cut. In one embodiment, a graft with an associated sensing attachment is used for an interposition vascular graft. For an interposition procedure, the sensing attachment can be associated with the graft prior to the start of the surgery. In one embodiment, the sensing attachment is associated with the interior of the graft, i.e., the sensing attachment is placed fully or partially inside the graft (lumen). In this way, a sensor attached to the sensing attachment will be able to perform detection and / or measurement of the fluid flowing through the graft after the graft with the associated sensing attachment is implanted in the patient. In cases where the sensor is to detect fluid pressure and / or fluid flow rate, the sensor should be located inside the sensing attachment, i.e., on the side of the sensing attachment facing the interior lumen of the graft. In one embodiment, the graft is associated with two sensing attachments, one at the inlet of the graft and the other at the outlet of the graft, where the sensors on the sensing attachments are in contact with the fluid flowing through the interior lumen of the graft.

[0449] The sensing attachment can be associated with the interior of the graft by compressing the sensing attachment from a non-compressed state (i.e., natural state) to a compressed state, holding the sensing attachment in the compressed state, placing the sensing attachment in the desired location within the graft while holding the sensing attachment in the compressed state, and then releasing the sensing attachment from the compressed state so that the sensing attachment returns to its natural state, i.e., non-compressed state. The non-compressed state should have dimensions such that the outer surface of the sensing attachment contacts the inner surface of the fabric of the graft with a certain pressure. The amount of pressure should be sufficient to hold the sensing attachment in the proper position within the graft. The pressure of the sensing attachment pushing against the inner wall of the graft will create a circumferential stress, where the circumferential stress should be sufficient to fix the sensing attachment in the proper position within the graft. A delivery system as described herein can be used to transfer the compressed sensing attachment to the site with the graft and then release the sensing attachment from the compressed state at the desired time and allow it to assume its natural state.

[0450] In one embodiment, the present disclosure provides a graft associated with a sensing attachment. Optionally, the association may place the sensing attachment wholly or partially within the lumen of the graft. In one embodiment, the sensor on the attachment may not face i.e., contact the graft such that when the graft is implanted in a patient, the sensor will contact the fluid passing through the graft. Optionally, the sensing attachment may be two sensing attachments, one placed at each end of the graft, with the sensing attachment placed within the graft in each case. In one embodiment, the present disclosure provides a method of associating a sensing attachment with a graft, wherein the method includes placing the sensing attachment within the lumen of the graft. Optionally, the sensing attachment is in a compressed state when placed within the graft and is then released from the compressed state after it is in the desired position within the graft and is held in place within the graft by hoop stress. In one embodiment, the present disclosure provides a method of monitoring intravascular fluid, the method including interposing a graft associated with a sensing attachment according to the present disclosure and then monitoring the fluid flowing through the graft using the sensor of the sensing attachment, as described herein.

[0451] In one embodiment, the present disclosure provides a stent graft associated with a sensing attachment. The association of the sensing attachment with the stent graft is described in detail below using an AAA stent graft as an example. However, the same disclosure applies to other stent grafts, such as other endovascular stent grafts, as well as gastrointestinal stent grafts and urinary stent grafts.

[0452] There are two main treatment methods for AAA, known as open surgical repair and endovascular aneurysm repair (EVAR). Surgical repair typically involves opening the dilated portion of the aorta, inserting a synthetic tube, and closing the aneurysm sac around the tube. In the case of surgical repair, the sensing attachment of the present disclosure may be associated with a stent graft in the operating room. For example, a spring-shaped sensing attachment may be mounted on the outer periphery of the stent graft, and the combination of the sensing attachment and the medical device may be inserted into the dilated portion of the aorta, and then the aneurysm sac around the combination may be closed. When the sensing attachment has any other shape, the same procedure may be used. For example, in the case where the sensing attachment has a clip shape, the sensing attachment may be clipped onto the stent graft, or in the case where the sensing attachment has a clip shape (such as a cuff bracelet shape), it may be clipped onto the stent graft, wherein in any case the combination of the sensing attachment associated with the stent graft is inserted into the aneurysm sac.

[0453] Minimally invasive endovascular aneurysm repair (EVAR) treatment methods for implanting stent grafts in the aneurysm region of the aorta have been developed as an alternative or improvement to open surgery. EVAR typically involves inserting a delivery catheter into the femoral artery, guiding the catheter to the aneurysm site via X-ray visualization, and delivering a synthetic stent graft to the AAA via the catheter. The stent graft is contained within the delivery catheter in a compressed form. Upon reaching the location of the AAA, the compressed stent graft is ejected from the delivery catheter, and thus, due to the elastic properties of the stent graft, the stent graft expands to its desired shape and size. According to the present disclosure, a sensing attachment is associated with the stent graft and the combination is compressed into the delivery catheter. When the compressed combination of the sensing attachment and the stent graft is delivered to the site of the AAA, the combination may be ejected from the delivery catheter, and thus each stent graft and the associated sensing attachment expand to their respective shapes and sizes due to the elastic properties of the stent graft and the sensing attachment.

[0454] In one embodiment, the present disclosure provides a stent graft associated with a sensing attachment. Optionally, the association may place the sensing attachment completely or partially within the lumen of the graft. The sensor on the attachment may not face, i.e., contact, the graft of the stent graft so that when the graft is implanted in a patient, the sensor will contact the fluid passing through the graft. Optionally, the association may place the sensing attachment completely or partially against the outer surface of the stent graft, i.e., not entirely within the lumen of the stent graft. In this case, the sensor on the attachment may not face, i.e., contact, the graft of the stent graft so that when the graft is implanted in a patient, the sensor will contact the fluid passing around the graft in the region of the aneurysm sac. Optionally, when the sensing attachment is placed in the lumen, the sensing attachment may be two or three sensing attachments placed at respective ends of the stent graft. In one embodiment, three sensing attachments are placed in the lumen, one at each orifice of the stent graft. In this way, when the sensor is a pressure sensor or other fluid measurement sensor, the sensor can monitor the fluid flowing in and out of the stent graft.

[0455] In one embodiment, the present disclosure provides a method of associating a sensing attachment with a stent graft, wherein the method includes placing the sensing attachment within the lumen of the graft. Optionally, the sensing attachment is in a compressed state when placed in the stent graft and is then released from the compressed state after it is in the desired position within the stent graft and is held in place within the stent graft by hoop stress. In one embodiment, the present disclosure provides a method of monitoring fluid within a stent graft, the method including surgically placing a stent graft associated with the sensing attachment of the present disclosure within an aneurysm sac and then monitoring the fluid flowing in the stent graft using the sensor of the sensing attachment, as described herein.

[0456] In one embodiment, the present disclosure provides a method of associating a sensing attachment with a stent graft, the method including placing the sensing attachment against an outer surface of the stent graft. Optionally, the sensing attachment is in an expanded state when it is placed against the outer surface of the stent graft and is then released from the expanded state after it is in a desired position around the stent graft to then assume its natural, i.e., expanded but not compressed, state and is held in place around the stent graft by hoop stress. In one embodiment, the present disclosure provides a method of monitoring fluid within a stent graft, the method including surgically placing a stent graft associated with a sensing attachment of the present disclosure within an aneurysm sac and then monitoring fluid flowing within the stent graft using a sensor of the sensing attachment, as described herein.

[0457] In one aspect, during the same procedure of implanting a medical device within a patient, a sensing attachment is associated with the medical device. This option will be described for the case where the sensing attachment is of a spring shape as shown in Figure 5A , Figure 5C or Figure 6 and the medical device is an AAA stent graft, however, the same principle applies to other sensing attachments and implantable medical devices as described herein.

[0458] In one aspect, introducing a sensing attachment into an endovascular graft does not interrupt the standard methods of abdominal aortic aneurysm treatment employed by a physician. For example, after the main graft portion of an AAA graft is in place, a secondary percutaneous delivery system carrying the sensing attachment enters the AAA sac and is positioned to deploy the sensing attachment around the maximum diameter of the AAA main graft and extend down the graft until the sensor system is fully deployed from the percutaneous delivery system. In one embodiment, the sensor can be placed to cover any angular arc within the AAA sac, from 1 degree to 360 degrees around the circumference of an AAA repair with a medical device graft. Optionally, a sensing attachment, e.g., having a spring shape, can be released around the outer diameter of the implanted graft and can be released before or after the final installation of an accessory iliac limb seal.

[0459] When a sensing attachment is placed around the outer diameter of an AAA graft treatment system for an abdominal aortic aneurysm, the compressive spring force that holds the sensing attachment in place adjacent to the stent graft can be created by the shaping of the body of the sensing attachment, e.g., the main tubular frame structure itself, or in a combination of nitinol tubes or communication antennas that form the base of the sensing attachment platform, e.g., platinum iridium wires that form a communication antenna. The characteristics of the sensing attachment, especially the metallic characteristics, can be used to achieve the necessary inward spring force that can maintain a circular shape in a single diameter configuration or a multi-diameter configuration where there is a large diameter and a small diameter. The inward spring force should have a minimal impact on the AAA inner diameter in human anatomy or on the graft material sealing function.

[0460] Optionally, a sensing attachment, e.g., having a spring shape, can be released and positioned within the inner diameter of the abdominal aortic graft treatment system so as not to displace below the iliac bifurcation of the AAA treatment graft. In this way, the sensing attachment can not only sense the blood waveform but also detect the effect on the waveform through sensors placed in the blood pathway.

[0461] In one implementation Figure 16 In the method of the situation shown, the inner graft is normally inserted and then the sensing attachment is inserted and placed on the inner graft before it is fully deployed in the vascular system, i.e., like a cigar band. The sensing attachment axially moves along the inner graft within the aneurysm sac to the appropriate position, and the inner graft is expanded so that the inner diameter of the sensing attachment contacts the outer diameter of the inner graft, such that the inherent circumferential stress of the sensing attachment fixes the sensing attachment against the inner graft to prevent any migration. As a second measure to prevent axial movement of the sensing attachment, the sensing attachment cannot migrate distally because the aneurysm sac is "isolated" via the inner graft.

[0462] On the one hand, after the procedure of implanting a medical device into a patient, the sensing attachment is associated with the medical device. This option will be described for the case where the sensing attachment is in the shape of a spring and the medical device is an AAA stent graft. However, the same principle applies to other sensing attachments and other implantable medical devices as described herein.

[0463] On the one hand, the present disclosure provides a sensing attachment of a geometry that can be delivered through a catheter of a single-tube or multi-tube configuration that enters the vasculature through a delivery system and is tracked to a designated site to release the sensing attachment in a similar designated area where an implant has been positioned into the vascular structure.

[0464] After association, the sensing attachment should be coiled, i.e., wound around the graft or the vessel wall, and held in place by interacting with the AAA graft, or by opposite forces on the wall, anchored to the wall or based on the coil length and the transition of the non-expanded abdominal aorta to the enlarged wall, and stabilized within the AAA sac region by contacting the aneurysm wall at the base of the enlarged aneurysm wall in the transition to the iliac artery wall.

[0465] As described herein, the sensing attachment can be associated with the medical device before, during, or after surgery. In any case, the sensing attachment needs to be implanted into the patient. When the sensing attachment is associated with the medical device before surgery, the combination of the sensing attachment and the associated medical device can be placed within a single delivery system such that the sensing attachment and the associated medical device are co-delivered to the patient. However, when the sensing attachment is associated with the medical device during or after surgery, separate delivery systems are used to deliver the sensing attachment and the medical device to the patient, i.e., one delivery system for the medical device and a separate delivery system for the sensing attachment.

[0466] In one embodiment, a catheter delivery system is used to deliver a sensing attachment to a patient. In one embodiment, the catheter delivery system is designed to accommodate a separate sensing attachment, or a sensing attachment associated with a medical device. Physicians performing AAA treatment are very familiar with the catheter delivery system for stent grafts. The present disclosure provides a catheter delivery system similar to the catheter delivery system with which physicians are familiar when performing AAA treatment. Using this embodiment, a physician can use the skills he or she has developed for treating AAA to also deliver the sensing attachment of the present disclosure to the patient being treated. This embodiment will be described for the case of delivering the sensing attachment alone; however, the same principles apply when delivering a combination of the sensing attachment and a medical device.

[0467] To deliver a medical device via a catheter delivery system, an elastic medical device is compressed into a very small size that can be inserted into the femoral artery. This is commonly done in the current practice of delivering and implanting stents or stent grafts via a catheter delivery system. The medical device is compressed into a very small size and then held in that small size by the catheter delivery system while it is delivered to the aneurysm site through the progressive movement of the delivery catheter through the artery. The medical device is typically held within the distal end of the delivery catheter. When the distal end of the delivery catheter reaches the location where the physician wishes to deploy the carried medical device, the release mechanism on the delivery catheter is activated by the physician, which causes the medical device to be released from the delivery catheter. Due to the elastic nature of the medical device, it will assume its uncompressed size and shape when released from the delivery catheter. The same principle is applied to deliver the sensing attachment or a combination of the sensing attachment and a related medical device to the desired location within the patient's body.

[0468] Figure 20 and Figure 21 An exemplary embodiment of a delivery device 500 for a sensing attachment 510 in a compressed state is shown. Although Figure 20 and Figure 21 the discussion is with respect to the delivery of the sensing attachment 510, the same principles apply when the sensing attachment is associated with a medical device, such as a stent graft. Thus, in the following discussion, reference to the sensing attachment 510 applies equally to a combination of the sensing attachment and a stent graft or other medical device.

[0469] Figure 20 and Figure 21The delivery device 500 can include a delivery catheter 520 and a handle 550 operably coupled to the delivery catheter 520. The delivery catheter 520 has a proximal end and a distal end and also has a lumen extending therethrough, where the lumen has a length and a cross-sectional area. The sensing attachment 510 in a compressed state is entirely located within the lumen of the delivery catheter and extends from a distal end 510d of the lumen to a proximal end 510p of the lumen. The delivery device 500 also includes a pusher 530 slidably disposed within the lumen of the delivery catheter 520. A portion of the pusher 530 is shown in Figure 21 where the remaining portion of the pusher 530 is located behind the sensing attachment 510 and is thus not visible in the view of Figure 21 . The pusher 530 is adjacent to but not within the compressed sensing attachment. In other words, the pusher 530 and the sensing attachment 510 are adjacent but separated because the pusher 530 does not enter or pass through the compressed sensing attachment 510.

[0470] As shown in Figure 21 , the distal portion of the delivery catheter 520 can include a distal sheath 524 that covers and constrains at least a portion of the compressed sensing attachment 510 in a radially compressed configuration and, in one embodiment, covers and constrains all of it. Thus, the delivery device 500 includes a distally movable sheath 524 that covers a portion of the inner lumen length of the delivery catheter, where the lumen portion contains a portion of the pusher 530 and a first portion of the sensing attachment 510 in a compressed state.

[0471] The slidably disposed pusher 530 engages the distally movable sheath 524 such that sliding of the pusher 530 causes movement of the movable sheath 524, where the movement exposes the compressed sensing attachment 510 and thus allows the compressed sensing attachment to assume a less compressed form. In other words, moving the distal sheath 524 in the distal direction can expose the sensing attachment 510, thereby releasing the compressed sensing attachment to assume a less compressed form. In Figure 21 , the distally movable sheath 524 has been moved in the distal direction and occupies the space shown as 524. In an embodiment, the pusher is a solid pusher, a flexible pusher, or a rotatable pusher.

[0472] In one embodiment, not shown in Figure 21 or Figure 22 , the delivery device includes a proximally movable sheath, where the proximally movable sheath covers a second portion of the inner lumen length of the delivery catheter, where the second portion of the lumen contains a second portion of the pusher and a second portion of the sensing attachment in a compressed state. The handle assembly 550 engages the proximally movable sheath and can cause movement of the proximally movable sheath such that the movement exposes the second portion of the compressed sensing attachment and thus allows the compressed sensing attachment to assume a less compressed form.

[0473] For example, a movable slider screw within the proximal handle 550 (which may also be referred to as a linear slider and is not shown in Figure 21 or Figure 22 may connect the handle 550 to a proximal movable sheath (not shown) to provide movement of the proximal movable sheath such that the movement exposes a second portion of the compressed sensing attachment. The proximal movable sheath may be moved by rotating the handle and utilizing a linear helical interaction to move the proximal outer sheath proximally from its position above the sensor attachment system. As an alternative, a locking slider and groove configuration may be used to connect the proximal movable sheath to the handle.

[0474] The proximal movable sheath should be able to move longitudinally and independently from the push rod, where the push rod is used to move the distal movable sheath.

[0475] In one embodiment, the push rod and the delivery catheter are arranged such that no offset is formed at the distal end of the delivery catheter. In one embodiment, the compressed sensing agent is not located within the offset at the distal end of the delivery catheter. In one embodiment, the push rod and the delivery catheter are arranged such that no depression is present at the distal end of the delivery catheter. In one embodiment, the compressed sensing agent is not located within the depression at the distal end of the delivery catheter.

[0476] In various embodiments, the present disclosure provides:

[0477] 1) A device comprising:

[0478] a) A delivery catheter having a proximal end and a distal end and having a lumen extending therethrough, the lumen having a length and a cross-sectional area;

[0479] b) A sensing attachment in a compressed state, the compressed sensing attachment being entirely located within the lumen of the delivery catheter;

[0480] c) A push rod slidably disposed within the lumen of the delivery catheter, the push rod being adjacent to the compressed sensing attachment rather than within the compressed sensing attachment;

[0481] d) A distal movable sheath covering a first portion of the inner lumen length of the delivery catheter, wherein the first portion of the lumen contains a first portion of the push rod and a first portion of the sensing attachment in a compressed state;

[0482] e) Wherein the slidably disposed push rod engages the distal movable sheath such that sliding of the push rod causes movement of the movable sheath, wherein the movement exposes the first portion of the compressed sensing attachment and thereby allows the compressed sensing attachment to assume a less compressed form.

[0483] 2) The device of embodiment 1, wherein the push rod and the delivery catheter are arranged such that no offset is formed at the distal end of the delivery catheter.

[0484] 3) The device of embodiment 1, wherein the compressed sensing attachment is not located within the offset at the distal end of the delivery catheter.

[0485] 4) The device of embodiment 1, wherein the push rod is a solid push rod.

[0486] 5) The device of embodiment 1, wherein the push rod is a flexible push rod.

[0487] 6) The device of embodiment 1, further comprising a handle and a distally movable sheath, wherein the handle is engaged with the proximally feedable sheath by means of a movable sliding screw, wherein the distally movable sheath covers a part of the inner lumen length of the delivery catheter, and wherein this inner lumen part contains a part of the push rod and a second part of the sensing attachment in a compressed state.

[0488] 7) The device of embodiment 1, further comprising a marker.

[0489] 8) The device of embodiment 1, further comprising a marker detectable by fluoroscopy.

[0490] 9) The device of embodiment 1, further comprising a marker in the distal part of the delivery catheter and a marker in the proximal part of the delivery catheter.

[0491] 10) The device of embodiment 1, further comprising a marker on the push rod and a marker on the distally movable sheath.

[0492] 11) The device of embodiment 1, further comprising a marker that is visible and positioned to provide direct visual communication on the placement of the distal part of the delivery system, and to apply the position of the distal end of the loaded sensor attachment system for release activation.

[0493] 12) The device of embodiment 1, further comprising a marker that is visible and positioned to provide direct visual communication on the placement of the proximal part of the delivery system, and to apply the position of the proximal end of the loaded sensor attachment system for secondary release activation.

[0494] 13) The device of embodiment 1, further comprising a marker that is visible and positioned to provide direct visual communication on the placement of covering the distal and proximal edges of the loaded sensor attachment system for release activation.

[0495] 14) The device of embodiment 1 further includes a marker, which is visible and positioned to provide direct radial orientation visual communication at a radially placed position distal to the loaded sensor attachment system for release activation.

[0496] 15) The device of embodiment 1 further includes a marker on the proximally movable sheath such that a doctor can visibly determine the radial orientation and linear travel of the proximal shaft during the surgical procedure.

[0497] 16) The device of embodiment 1, wherein the push rod includes a lumen extending through the entire length of the push rod.

[0498] 17) The device of embodiment 1, wherein the push rod includes a lumen extending through the entire length of the push rod, and the push rod lumen enables the delivery catheter to move over the guide wire.

[0499] 18) The device of embodiment 1, wherein the push rod includes a lumen extending through the entire length of the push rod, and the push rod lumen enables a doctor to irrigate the AAA sac and thereby ensure that there is no blood clot in the AAA sac that may impede the function of the device.

[0500] 19) The device of embodiment 1, wherein the distal end of the delivery catheter terminates at a distal tip.

[0501] 20) The device of embodiment 1, wherein the distal end of the delivery catheter terminates at a distal tip, and the distal tip has a configuration that provides manipulable characteristics during the insertion and positioning of the sensing attachment in the patient's body.

[0502] 21) The device of embodiment 1, wherein the distal end of the delivery catheter terminates at a distal tip, and the distal tip includes a polymeric material having a gauge hardness in the range of 25A to 95A.

[0503] 22) The device of embodiment 1, wherein the distal end of the delivery catheter terminates at a distal tip, and the distal tip has a proximal end and a distal end, and the proximal end has a diameter that can interface with the distal portion of the distally movable sheath and then extends in a tapered configuration and transitions to a tubular form, and the tubular form has an outer diameter smaller than the outer diameter of the distally movable sheath and an inner diameter that enables irrigation or the presence of a guide wire within the tubular form.

[0504] 23) The device of embodiment 1, wherein the distal end of the delivery catheter terminates at a distal tip, and the distal tip has a proximal end and a distal end, and the proximal end has a diameter that can interface with the distal portion of the distally movable sheath and then extends in a tapered configuration and transitions to a tubular form, and the tubular form has an outer diameter smaller than the outer diameter of the distally movable sheath and an inner diameter that enables irrigation or the presence of a guide wire within the tubular form, and the tapered configuration should have a length from the larger diameter to the smaller diameter of 5 mm to 60 mm as measured.

[0505] 24) The device of embodiment 1, wherein the distal end of the delivery catheter terminates at a distal tip, and wherein the distal tip has a length of 5 mm to 60 mm.

[0506] 25) The device of embodiment 1, wherein the distal end of the delivery catheter terminates at a distal tip, and wherein the distal tip has a diameter configuration selected from coaxial and non - coaxial, and wherein the diameter configuration facilitates the maneuverability of the delivery catheter.

[0507] 26) The device of embodiment 1, wherein the distal end of the delivery catheter terminates at a distal tip, and wherein the distal tip does not have any markers.

[0508] 27) The device of embodiment 1, wherein the distal end of the delivery catheter terminates at a distal tip, and wherein the distal tip includes a marker.

[0509] 28) The device of embodiment 1, wherein the distal end of the delivery catheter terminates at a distal tip, and wherein the distal tip includes a marker detectable by fluoroscopy.

[0510] Markers, also known as marker bands, are known for other delivery systems and can be used in the devices of the present disclosure. A marker can be a radiopaque marker, which can include a heavy metal having an atomic number of at least about 70, including gold, platinum, tantalum, etc. In some cases, the radiopaque marker can include a powdered heavy metal such as bismuth or tantalum. See, for example, U.S. Patent Nos. 5,429,617; 5,772,642 and 7,641,647; and U.S. Patent Publications Nos. US20060258982 and US20160113796.

[0511] A guide wire for guiding the delivery catheter to a desired location within a patient is known for other delivery shafts and can be part of the device of the present disclosure or used in combination with the device of the present disclosure. See, for example, U.S. Patent No. 69366065 and U.S. Patent Publications Nos. US20060074477; US20070299502 and US20080172122. In use, the guide wire can be used with the delivery catheter to deploy a sensing attachment or a combination of sensing attachments associated with a medical device such as a stent graft to a desired location within a patient.

[0512] In one embodiment, the present disclosure provides a method that includes packaging and / or preparing, such as processing, an assembly that includes a delivery catheter and a sensing attachment system or a combination of the assembly and a sensing attachment associated with a medical device such as a stent graft. Such packaging and preparation facilitate the assembly reaching the desired treatment facility and location, such as a hospital, ready for use. The sensing attachment can be shipped to the desired treatment facility in a constrained (e.g., compressed) or unconstrained (natural) configuration. In one embodiment, the assembly is packaged and transported in a constrained configuration. The sensor attachment can be external to the delivery catheter or preloaded in the delivery catheter. After packaging, but before transportation, the assembly can be sterilized, for example, by gamma radiation or electron beam. Before packaging, the assembly can be sterilized, for example, by a gas method such as exposing the assembly to gases such as ethylene oxide (EO), ozone, nitrogen oxides, and chlorine dioxide. In one embodiment, the present disclosure provides a sensing assembly in packaged form, wherein the sensing assembly has been optionally sterilized. In one embodiment, the present disclosure provides, in packaged form, a sensing assembly in combination with a medical device, such as a stent graft, wherein optionally the sensing assembly and the medical device, such as the stent graft, have been sterilized. Optionally, in one embodiment, when the sensing attachment is within the package, such as when the sensing attachment is preloaded into the delivery catheter, the sensing attachment is in a constrained form. Optionally, in one embodiment, when the sensing attachment is within the package, such as when the sensing attachment is external to the delivery catheter that is also within the package, the sensing attachment is in an unconstrained form, or the sensing attachment and the graft or stent graft are both in an unconstrained form, or the sensing attachment is packaged separately in an unconstrained form without a delivery system.

[0513] According to the present disclosure, the materials and compression schemes for inserting a sensing attachment via a catheter are similar to those currently used for coronary stents and endovascular grafts. The sensing attachment can be radially compressed to fit within the catheter delivery system. It will be delivered via a catheter similar to current coronary stent and endovascular stent technologies, placed within its preferred arterial position, and deployed in a similar manner. Optionally, if a shape memory metal is used for the loop material, the sensing attachment can be assembled in the loop state and cooled before insertion into the delivery system to present Figure 8 or other optimized geometries to minimize the radial dimension and elongate the axial dimension. This change in shape is intended to facilitate insertion via a smaller French catheter. For a sensing attachment placed external to an endovascular graft within an aneurysm sac, the sensing attachment is placed before the endograft within the aneurysm sac, and if minimal contact with the vessel wall or endograft within the aneurysm sac is desired, it can be segmented and expanded into a non-circular shape to better match the asymmetric shape of the aneurysm sac.

[0514] Accordingly, in one embodiment, the present disclosure provides a sensing attachment delivery system for intravascular and external or internal deployment of a sensing attachment around an endovascular repair graft, the system comprising: a delivery catheter including a tubular housing at a distal end portion of the catheter; a sensing attachment encapsulated by a tubular configuration and constrained within the tubular housing, wherein the sensing attachment is configured to transition between an elongated radially compressed state and a shortened radially expanded state. The delivery system may have radiopaque markers and / or tactile features that assist in identifying the delivery location.

[0515] In one aspect, the present disclosure provides methods and systems for monitoring medical devices, particularly implanted medical devices, and / or the environment surrounding a medical device. Such monitoring can provide information related to the status and function of the medical device, where the information can be used by a healthcare provider to inform decisions regarding the treatment or prognosis of a patient. Such monitoring can also, or alternatively, provide information related to the status of the patient, which again can be used by a healthcare provider to inform decisions regarding the treatment or prognosis of the patient. Such information can also, or alternatively, provide information about the environment in which the sensing attachment is placed, for example, in some cases, a stent graft can be implanted with one or more complementary implants such as arterial embolization units. Although the sensing attachment is associated with the stent graft, the sensing attachment can detect and / or measure environmental characteristics that provide information about the operation of nearby complementary implants.

[0516] The operation of a sensing attachment associated with a medical device will be described for embodiments of the present disclosure, where the sensing attachment is in the form of a spring and the medical device is an endovascular graft such as an AAA stent graft. However, the same principles apply to other sensing attachments and other implantable medical devices described herein. Thus, in one aspect, the spring-shaped sensing attachment complements an endovascular graft, such as an AAA stent graft, and converts such a graft from a passive state to an intelligent active state that can monitor the vascular biophysiology near the endovascular graft.

[0517] Once the sensing attachment is placed in the desired location, the sensing attachment is active and can be balanced and calibrated in conjunction with anatomical outputs measurable by sensors on the platform. Having multiple sensors on any sensing attachment provides an opportunity to implement sensor calibration. In one embodiment, the sensing attachment has multiple sensors. Thus, the pressure readings in one sensor can be compared to those of its immediate neighbors, averaged, and adjusted to account for any drift. This will be done externally as part of post-processing the signal. This is useful because the sensor may inadvertently contact the lumen wall and / or it may have tissue overgrowth that limits its sensitivity. Additionally, for attachment pressure sensors within arterial blood flow, they can always be calibrated against external BP pressure measurements and adjusted via algorithms to reflect changes in the mean pressure and pulse pressure across the arterial system.

[0518] The sensing attachments of the present disclosure carry one or more sensors, such as a sensor array, to detect or measure specific descriptive information in the region of an implanted medical device. For example, when a medical device is implanted within an AAA sac, the sensor or sensor array can detect one or more of pressure, vascular vibrations, sounds, temperature, etc., which can provide an appropriate indication of acute and potential problems that may be caused by biological, arterial muscle, or therapeutic graft changes and that can affect the expected outcome of a corrective procedure.

[0519] Grafts and stent grafts are commonly used in a variety of medical procedures to open and / or maintain the lumen of body passages (such as arteries, the gastrointestinal tract, the urinary tract). However, they are most commonly used in vascular procedures, such as in the treatment of aortic aneurysm disease. An aortic aneurysm (AA) is an aortic dilation that is typically caused by an underlying disease (usually atherosclerosis) that results in a weakened blood vessel wall. As the aneurysm grows larger over time, the risk that it will burst or rupture increases rapidly; if left untreated, it can lead to massive bleeding and death. Inserting a stent graft into the aneurysm not only simply keeps the diseased blood vessel open, but also bridges the dilated section of the blood vessel from a healthy blood vessel to a healthy blood vessel.

[0520] However, currently available stent grafts have many limitations, such as endoleak, migration, detachment, wear and durability issues, rupture, stenosis, kinking, and malposition. For example, current stent grafts are prone to continuous leakage around the stent graft area and into the aneurysm sac (a condition known as "endoleak"). As a result, the pressure within the aneurysm sac does not decrease, remains at or near arterial pressure, and there is still a risk of rupture. Endoleak is one of the most common and clinically dangerous complications in stent graft placement, and the early detection and treatment of endoleak remain an important medical problem. In certain embodiments, the sensing attachment of the present invention has a pressure detection sensor capable of detecting elevated pressure within the aneurysm sac and warning the patient and / or the attending physician of a potential endoleak. The pressure sensor on the sensing attachment can identify an increase in the extra-luminal pressure (the outer surface of the graft in contact with the vessel wall); this indicates that the pressure within the aneurysm sac is increasing and the aneurysm is no longer excluded from the circulation. Since most endoleaks are asymptomatic in patients (rupture is usually the first symptom), a gradual or rapid increase in the extra-luminal pressure of the stent graft (or the aneurysm wall pressure) is an important early indicator for seeking medical care and ensuring an investigation of its potential causes. The sensing attachment of the present disclosure, when properly placed, can monitor such a gradual or rapid increase in the extra-luminal pressure of the stent graft. Currently, no such continuous monitoring and early detection system is available for identifying endoleak, and the embodiments of the present invention will greatly facilitate the identification and early treatment of this potentially fatal complication in stent graft treatment.

[0521] There are 5 common types of perigraft leakage (endoleak), and the corrective measures may vary depending on the underlying cause. In certain embodiments, the sensing attachment of the present disclosure has a fluid pressure sensor, a contact sensor, a position sensor, a pulse pressure sensor, a blood volume sensor, a blood flow sensor, a chemical sensor (e.g., for blood and / or other fluids), a metabolic sensor (e.g., for blood and / or other fluids), an accelerometer, a mechanical stress sensor, a temperature sensor, etc., which can provide useful information for the doctor to determine which type of endoleak may be present.

[0522] Multiple sensors fixed to a construct located outside the AAA graft ( Figure 15 , Figure 16 , Figure 17 , Figure 18 and Figure 19)It is designed to measure extravascular leakage into the aneurysm sac due to at least one of four types of endoleak. This is crucial because with early detection, clinicians may successfully treat the patient. The current standard of care allows or only allows ultrasound and / or contrast CT imaging of vascular grafts. In cases where it is not detected prior to the imaging session, the timing of intervention can lead to graft failure and death as few symptoms manifest before failure.

[0523] Type I endoleak is leakage that occurs around the top or bottom of the stent graft. Since the blood flowing out of the top or bottom region of the stent graft has a high flow rate, Type I leaks are usually addressed with a greater sense of urgency once they are detected. Type II endoleak is the most common. These are leaks that occur when blood flows from an aortic branch or other stented vessel into the aneurysm sac. The blood flows into the aneurysm sac cavity through small branches that enter the treated aneurysm. Type III occurs when the overlapping stent graft components separate, which allows pressurized blood flow into the aneurysm cavity. Type IV occurs when there is blood flow through the pores of the stent graft.

[0524] Multiple pressure sensors can be used to detect endoleak as an increase in pressure above baseline. Additionally, if the pressure sensors are arranged in a geometric pattern around the circumference of the AAA host graft, the location of the leak can be approximated as the pulsatile jet emanating from the leak will have a local effect, i.e., the local high-speed jet will have a local region of lower dynamic pressure. This can be used to help clinicians understand the location and type of endoleak, enabling them to formulate a cohesive treatment strategy.

[0525] Motion sensors can also detect the root cause of Type I endoleak. For bifurcated grafts, a longitudinal force is applied to the graft due to the arterial pulse pressure. When the pressure wave reaches the bifurcation, this applies a cyclic force to the graft that must be counteracted by the circumferential stress that secures the graft to the proximal and distal necks. Type I endoleak occurs if the proximal neck of the AAA graft fails to maintain its seal against the host aorta due to (1) the longitudinal force being greater than the radial circumferential stress exerted by the AAA graft; (2) further dilation of the host aorta due to aneurysm disease progression, or (3) a combination of items 1 and 2. Therefore, knowing whether the proximal (or distal) connection of the AAA graft has moved from its initial insertion reference position can provide a precursor for Type I endoleak, allowing treatment before failure.

[0526] The first type of endoleak (type I endoleak) occurs when blood leaks directly around the stent graft (proximally or distally) and into the aneurysm sac. This type of endoleak may persist from insertion due to poor sealing between the stent graft and the vessel wall, or may develop later due to loss of seal. Additionally, this problem may arise due to changes in the position or orientation of the stent graft relative to the aneurysm as the aneurysm grows, shrinks, elongates, or shortens over time after treatment. Type I endoleak also commonly occurs if the stent graft "moves downstream" from its initial placement point due to blood flow and arterial pulsations. Representative sensing attachments associated with the stent graft can have contact and / or position sensors, where the sensing attachments are located proximally and distally (optionally, and within the body of the stent graft) of the stent graft to assist in identifying type I endoleak. Sensing attachments equipped with pressure and / or contact sensors can indicate a suspected endoleak by detecting elevated intraluminal pressure; in addition, loss of contact between the proximal and / or distal end of the graft and the vessel wall (as detected by the contact sensor) will indicate the presence of type I endoleak, while loss of contact of the stent graft body with the vessel wall will suggest the location, size, and extent of the endoleak present in the aneurysm sac. Moreover, sensing attachments having position sensors and / or accelerometers and located proximally and / or distally (optionally, and within the body of the stent graft) of the stent graft can detect movement (migration) of the stent graft from its original placement point (a common cause of type I endoleak), and also assist in determining the size and location of the endoleak (by detecting deformation of the stent graft wall).

[0527] As described herein, in certain embodiments, specific sensors attached to the sensing attachment can be identified by their USI as well as their location within the sensing attachment. Thus, based on knowledge of the position and activity of an overall set of sensors, a more comprehensive picture or analysis of the overall function of the stent graft (and the patient's response to the stent graft) can be determined. For example, when analyzed as a group, a set of sensors can be utilized to determine the specific type of endoleak, the degree and location of the endoleak. Additionally, the collection of sensors can be used to evaluate a variety of other conditions, including, for example, kinking or deformation of the stent graft, and stenosis of the stent graft.

[0528] Data collection from the sensors of the sensing attachment can also be used to ensure proper placement of the stent graft (e.g., no leakage during placement), and that the stent graft is properly positioned (e.g., and the side arms are properly attached to the body of the stent graft).

[0529] A second type of graft leakage (type II endoleak) may occur because collateral arteries extend from the treated segment of the vessel (usually lumbar, testicular, and / or inferior mesenteric arteries). Once the aneurysm is excluded by the stent graft, blood flow may reverse within these vessels and continue to fill the aneurysm sac around the stent graft. The sensing adjuncts of the present disclosure may have contact and / or position sensors, and two such sensing adjuncts may be associated at the proximal and distal ends of the stent graft (optionally, and within the body of the stent graft) to assist in identifying type II endoleaks. A sensing adjunct equipped with pressure and / or contact sensors and associated with an implanted stent graft may indicate a suspected endoleak by detecting elevated intraluminal pressure; in addition, continuous contact with the vessel wall at the proximal and / or distal end of the graft (as detected by a contact sensor) will indicate that the endoleak may be type II, while loss of contact between the stent graft body and the vessel wall will suggest the location, size, and extent of the endoleak present in the aneurysm sac. Finally, sensing adjuncts located at the proximal and distal ends of the stent graft and having position sensors and / or accelerometers will confirm that the stent graft has not migrated from its original placement site, while those sensors located within the body of the stent graft will assist in determining the size and anatomical location of the endoleak (by detecting deformation of the stent graft wall), which may imply the vessel responsible for the type II endoleak.

[0530] A third type of endoleak (type III endoleak) may occur due to disconnection of the device (in the case of modular or segmented devices). Due to the complex vascular anatomy, the diversity of aneurysm shapes, and the need to customize a suitable stent graft for a particular patient, many stent grafts are composed of multiple parts that are inserted separately and constructed into a final configuration within the aorta. As the aneurysm grows, shrinks, elongates, or shortens over time after treatment, its shape changes, and disconnection of the device at the connection points may develop. Sensing adjuncts may be specifically associated with two or more of these segmented devices, where the sensing adjuncts may have, for example, contact and / or position sensors. These sensors may be monitored to assist in evaluating the integrity of the seal between the stent graft segments. During placement of the stent graft, complementary sensing adjuncts may have paired / matching contact sensors on their respective sensing adjuncts, which may be used to confirm that precise and accurate connection has been achieved during construction of the device. If a type III endoleak develops, a gap / discontinuity between the contact sensors on the sensing adjuncts located on complementary segments may be detected to determine the location and extent of the endoleak present.

[0531] The fourth type of endoleak (type IV endoleak) is due to the development of holes within the graft material through which blood can leak into the aneurysm sac. The continuous pulsation of the blood vessel causes the graft material to rub against the metal stent, eventually leading to fabric wear and graft failure. Representative sensing attachments of the present disclosure have 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 fluids), metabolic sensors (e.g., for blood and / or other fluids), accelerometers, mechanical stress sensors, temperature sensors, and similar sensors that can be associated with the vicinity of the fabric of the stent graft body to assist in identifying type IV endoleaks. If a defect develops in the graft material, the associated sensors will help determine the size and location of the endoleak by detecting deformations and defects in the stent graft wall. In extreme cases, a defect in the stent graft wall can lead to stent graft rupture; a condition that can be detected early due to embodiments of the present invention.

[0532] The last type of endoleak (type V endoleak) is leakage of unknown origin. Representative sensing attachments equipped with 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 fluids), metabolic sensors (e.g., for blood and / or other fluids), accelerometers, mechanical stress sensors, temperature sensors, etc. can be associated with the stent graft and indicate the presence of a suspected endoleak by detecting elevated intraluminal pressure. Additionally, a loss of contact with the vessel wall detected by the contact sensor, changes in the position sensor, and / or movement detected by the accelerometer can detect changes in the stent graft and help determine the size and location of the endoleak (by detecting deformations in the stent graft wall).

[0533] The sensing attachment associated with a stent graft according to the present disclosure can provide sensing information to serve a variety of important clinical functions. For example, during the initial placement of the stent graft, this information is useful to the clinician to determine whether it is anatomically correctly placed, whether there is leakage around the graft, whether the stent graft segments are correctly assembled, to detect kinking or deformation of the graft, to determine whether there is uniform blood flow through the device - to name just a few important functions. Malpositioning of the stent graft, whether at the time of placement or due to subsequent movement / migration, is a common complication of stent graft treatment. The sensing attachment associated with a stent graft according to the present disclosure can be used to confirm correct initial placement and any subsequent repositioning. Separation of the entire graft (from the artery), or individual graft segments from each other, is another problematic complication of stent graft insertion and ongoing treatment. The sensing attachment associated with a stent graft according to the present disclosure can have the ability to detect movement / separation of the entire stent graft as well as movement and / or separation of the individual segments, thus providing valuable diagnostic information to the clinician and patient. Kinking of the stent graft during deployment and / or after placement due to subsequent movement, if it occurs, is also an important clinical problem. The sensing attachment associated with a stent graft according to the present disclosure has position sensors and accelerometers that are capable of detecting deformation and kinking of the stent graft.

[0534] In some cases, due to external compression (such as endoleak), stenosis (growth of thickened vascular tissue called neointimal hyperplasia on the inner surface of the stent graft), or formation of thrombotic clots, the lumen of the stent graft may narrow and restrict blood flow through the graft. The sensing attachment associated with a stent graft according to the present disclosure has a variety of sensors capable of detecting and differentiating the types of stenosis. Blood flow, fluid pressure, and blood volume sensors on the sensing attachment located on the inner lumen surface of the stent graft can detect the presence and location of stenosis, which is due to increased blood flow velocity and increased blood (and pulse) pressure at the stenotic site (relative to the normal segments of the graft), as well as stenosis caused by external compression (such as the presence of endoleak discussed above). When the blood flow sensor, blood metabolism, and / or chemical sensors (e.g., for blood and / or other fluids) are covered by vascular tissue or clot, stenosis due to neointimal hyperplasia or clot formation will be detected as a "dead spot" and / or a change in the readings on the lumen surface; while the intraluminal pressure sensor and accelerometer will not show a change in intraluminal pressure or deformation of the stent graft wall (which occurs in the case of endoleak). The metabolism and chemical sensors are capable of determining the difference between stenosis (normal pH value and physiological readings) and clot (decreased pH value and changed physiological readings). The present disclosure provides sensing attachments that can be associated with a stent graft to make these determinations, as well as methods for making these determinations.

[0535] As mentioned, stent grafts are typically placed in an artery (usually the aorta) at the anatomical location where important arterial side branches originate. The most important of these are the renal arteries, but aortic aneurysms can affect the lumbar arteries, testicular arteries, inferior mesenteric artery, and internal iliac arteries. To keep these arteries patent (and prevent them from being blocked by the placement of a stent graft), stent grafts with holes (or fenestrations) have been developed, which allow blood to flow through the graft and into the arteries branching off the aorta. FEVAR (fenestrated endovascular aneurysm repair) is a stent graft design and treatment method that can keep important vessels originating from the aorta patent. The sensing attachment of the present disclosure has sensors such as blood flow sensors, fluid pressure sensors, pulse pressure sensors, blood volume sensors, and / or blood chemistry and metabolism sensors, where the sensing attachment can be associated with the stent graft at the fenestration site to monitor blood flow through the collateral. Similarly, the sensing attachment of the present disclosure can also have position sensors, contact sensors, and / or accelerometers, which can be associated at the fenestration location to monitor the patency of the collateral (due to stenosis and / or kinking, migration, and blockage of the arterial branches by the stent graft itself).

[0536] In addition, patients in need of stent grafts typically have extensive cardiovascular disease, resulting in impaired cardiac and circulatory function. For example, patients receiving stent grafts are at increased risk of myocardial infarction (heart attack), congestive heart failure, renal failure, and arrhythmias. The aorta is the largest blood vessel originating from the heart, and thus, monitoring certain hemodynamic and metabolic parameters within the aorta can provide clinicians with very important information regarding the patient's cardiac, renal, and circulatory function. The sensing adjuncts associated with the stent grafts according to the present disclosure include 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 fluids), metabolic sensors (e.g., for blood and / or other fluids), accelerometers, mechanical stress sensors, temperature sensors, etc. suitable for such purposes. Representative sensing adjuncts of the present disclosure can have pressure sensors, pulse pressure sensors, pulse contour sensors, blood volume sensors, blood flow sensors, which can be associated with the stent grafts and provide information that can be used by a person of ordinary skill in the art to calculate and monitor important physiological parameters such as cardiac output (CO), stroke volume (SV), ejection fraction (EF), 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, CA) uses pulse contour analysis to calculate stroke volume (SV) and systemic vascular resistance (SVR); Most Care (Vytech, Padora, Italy) uses pressure recording analysis method (PRAM) to estimate cardiac output (CO) from the analysis of arterial pressure waveforms. Changes in cardiac output (CO), stroke volume (SV), ejection fraction (EF), and cardiac index (CI) are important in detecting complications such as myocardial ischemia and infarction; they can also assist clinicians in implementing and adjusting cardiac medications and dosages. Pulse pressure sensors, pulse contour sensors, and heart rate sensors, which are part of the sensing adjuncts and associated with the stent grafts, can help detect and monitor arrhythmias and abnormal heart rates; they can also be used to monitor the patient's response to cardiac medications that affect heart rate and rhythm. Clinicians can use systolic blood pressure (sBP), diastolic blood pressure (dBP), mean arterial pressure (mAP), systemic vascular resistance (SVR), and total peripheral resistance (TPV) readings to monitor the dosage and effectiveness of blood pressure-lowering medications and pressor (increase blood pressure) agents.

[0537] As described above, patients in need of a stent graft typically have medical problems associated with cardiovascular disease, such as kidney injury or renal failure. The renal arteries originate from the aorta and are typically very close to the typical location where the stent graft is placed; thus, monitoring certain hemodynamic and metabolic parameters within the aorta can provide doctors and patients with very important "real-time" information about ongoing kidney function. The sensing attachment associated with the stent graft according to the present disclosure can include circulatory sensors (as described herein) suitable for monitoring kidney function, as well as chemical sensors (e.g., for blood and / or other fluids) and metabolic sensors (e.g., for blood and / or other fluids). Examples of blood chemistry and metabolic sensors that can be used in this embodiment include, but are not limited to, blood urea nitrogen (BUN), creatinine (Cr), and electrolytes (calcium, potassium, phosphate, sodium, etc.). Additionally, combining metabolic data with hemodynamic data and urine analysis can allow clinicians to calculate the glomerular filtration rate (GFR), which is a very useful measure of kidney function. This information is particularly useful in the management of dialysis patients to monitor the timing, effectiveness, and frequency of dialysis treatments.

[0538] Finally, due to the numerous complications described above, there is long-term uncertainty regarding the entire stent graft technology as a treatment for aortic aneurysms. Although much more invasive and traumatic, standard open surgical aneurysm repair is very durable and effective. Uncertainties regarding endovascular stent grafts include whether they will reduce the aneurysm rupture rate, the rate of perigraft leakage (endoleak), device migration, the ability to effectively exclude the aneurysm long-term, and device rupture or disconnection. The sensing attachment associated with the stent graft according to the present disclosure has the ability to detect and monitor many (if not all) of the above complications and represents an important advancement in the overall stent graft treatment.

[0539] In one embodiment, the sensor will acquire the sensed information and transmit the sensed information to a storage chip. The information is then formed into a suitable and defined data packet and transmitted from the storage chip to a receiver located outside the patient's body for any processing, recording, timestamping, or algorithmic calculations to provide the data in a digital, pictorial, or graphical manner that enables a trained reviewer to evaluate the status of the implant and / or the surrounding environment and make an appropriate decision based thereon, e.g., to perform an anticipated correction to the procedure.

[0540] In one embodiment, the sensing attachment supplements the endovascular graft and transforms the graft from a passive state to an intelligent active state by monitoring vascular biophysiology.

[0541] Placing a stent with sensors at the proximal and distal locations of the AAA graft enables a series of hemodynamic assessments. An exemplary sensing attachment placed inside the AAA graft, i.e., within the lumen, is in Figure 16is shown, where the sensing attachment 122 is fully within the stent graft at the distal location, and the sensing attachment 120 is partially placed inside and partially outside the lumen, i.e., on the outer surface of the stent graft, at the proximal location, where blood flows from the proximal end to the distal end of the stent graft. Although Figure 15 , Figure 17 and Figure 18 show a sensing attachment fully on the outer lumen surface of the stent graft, the sensing attachment can alternatively be located on the inner lumen surface of the stent graft. Also, although Figure 15 , Figure 17 and Figure 18 show a sensing attachment located around the center of the stent graft within the aneurysm sac, the sensing attachment can alternatively be located at the proximal and / or distal end of the stent graft. Thus, in one embodiment, the stent graft is associated with two sensing attachments, both located within the stent graft lumen, one at the proximal end of the stent graft and the other at the distal end of the stent graft.

[0542] Using these locations, i.e., pressure and / or flow sensors within the lumen at the proximal and distal ends of the stent graft, a complete assessment of the patient's hemodynamic state can be determined and provided to the patient and the clinician. Data from the pressure and / or flow sensors can be used to calculate a series of hemodynamic parameters, including heart rate, blood pressure, pulse pressure, cardiac output, stroke volume, total peripheral resistance, and graft patency. Overall, these parameters can be used to enable the clinician to manage a range of disease pathologies using drug interventions, including hypertension, congestive heart failure, and atrial fibrillation, at a much higher temporal frequency than the current standard of care provided by infrequent clinician visits.

[0543] The sensing attachment can be incorporated into an environment that communicates with the sensing attachment. An exemplary environment is an operating room where the sensing attachment is being implanted into a patient by a healthcare professional. In the case where the sensing attachment has been implanted into a patient, another exemplary environment is the patient's home. Yet another exemplary environment is a doctor's office where a patient with an implanted sensing attachment is being evaluated, for example. A detailed description of an exemplary environment in the patient's home is provided below. However, the features and connectivity described are similarly present in other environments where there is a patient with an implanted sensing attachment, such as an operating room and a doctor's office, although not described in as much detail herein.

[0544] Figure 22An example sensing accessory environment 1000 is shown, including a map of the environment in a patient's home. In this environment, a sensing accessory 1002, including an implantable reporting processor 1003, has been implanted in a patient (not shown). The implantable reporting processor (IRP) 1003 is arranged and configured to collect data, including, for example, medical and health data of the patient associated with the device, as well as operational data of the sensing accessory 1002 itself. The sensing accessory 1002 communicates with one or more home base stations 1004 or one or more smart devices 1005 during different phases of monitoring the patient.

[0545] The sensing accessory 1002 includes one or more sensors that collect information and data, including medical and health data of the patient associated with the sensing accessory, as well as operational data of the sensing accessory 1002 itself. The sensing accessory 1002 collects data at various different times and at various different rates during the monitoring of the patient, and may optionally store the data in memory until it is transmitted outside the patient's body. In some embodiments, the sensing accessory 1002 may operate during multiple different phases of monitoring the patient. For example, more data may be collected shortly after the sensing accessory 1002 is implanted in the patient, but less data is collected later.

[0546] The amount and type of data collected by the sensing accessory 1002 may vary from patient to patient, and the amount and type of data collected may change for an individual patient. For example, a medical practitioner studying the data collected by the sensing accessory 1002 of a particular patient may adjust or otherwise control how the sensing accessory 1002 collects future data.

[0547] The amount and type of data collected by the sensing accessory 1002 may be different for different types of patient conditions, for different patient demographics, or for other differences. Alternatively or in addition, the amount and type of data collected may change over time based on other factors, such as how the patient is healing or feeling, how long the monitoring process is expected to last, how much power remains in the sensing accessory 1002 and how much power should be conserved, the type of movement being monitored, the body part being monitored, etc. In some cases, the data collected is supplemented with personal descriptive information provided by the patient, such as subjective pain data, quality of life metric data, comorbidities associated with the patient and the sensing accessory 1002, perceptions or expectations, etc.

[0548] Once the sensing attachment 1002 is implanted in a patient and the patient returns home, the sensing attachment can begin communicating outside the patient's body, within a home environment. The communication can be with, for example, a home base station 1004, a smart device 1005 (e.g., the patient's smart phone), a connected personal assistant 1007, or two or more of the home base station and the smart device, and the connected personal assistant can communicate with the sensing attachment 1002. The sensing attachment 1002 can collect data at a determined rate and time, a variable rate and time, or otherwise controllable rate and time. Data collection can begin when the sensing attachment 1002 is initialized in the operating room, under the guidance of a practicing physician, or at some later point in time. At least some of the data collected by the sensing attachment 1002 can be transmitted directly to the home base station 1004, directly to the smart device 1005, directly to the connected personal assistant 1007, transmitted to the base station via one or both of the smart device and the connected personal assistant, connected to the smart device via one or both of the base station and the connected personal assistant, or connected to the connected personal assistant via one or both of the smart device and the base station. Here, "one or both" means via a single item alone, as well as via two items in series or parallel. For example, data collected by the sensing attachment 1002 can be transmitted to the home base station 1004 alone via the smart device 1005, alone via the connected personal assistant 1007, sequentially via the smart device and the connected personal assistant, sequentially via the connected personal assistant and the smart device, and directly, and possibly simultaneously via the smart device and the connected personal assistant. Similarly, data collected by the sensing attachment 1002 can be transmitted to the smart device 1005 alone via the home base station 1004, alone via the connected personal assistant 1007, sequentially via the home base station and the connected personal assistant, sequentially via the connected personal assistant and the home base station, and directly, and possibly simultaneously via the home base station and the connected personal assistant. Additionally, for example, data collected by the sensing attachment 1002 can be transmitted to the connected personal assistant 1007 alone via the smart device 1005, alone via the home base station 1004, sequentially via the smart device and the home base station, sequentially via the home base station and the smart device, and directly, and possibly simultaneously via the smart device and the home base station.

[0549] In various embodiments, one or more of the femtocell 1004, the smart device 1005, and the connected personal assistant 1007 ping the sensing attachment 1002 at periodic, predetermined, or other times to determine whether the sensing attachment 1002 is within the communication range of one or more of the femtocell, the smart device, and the connected personal assistant. Based on the response from the sensing attachment 1002, one or more of the femtocell 1004, the smart device 1005, and the connected personal assistant 1007 determine that the sensing attachment 1002 is within the communication range and may request, command, or otherwise direct the sensing attachment 1002 to transmit the data it has collected to one or more of the femtocell 1004, the smart device 1005, and the connected personal assistant 1007.

[0550] In some cases, each of one or more of the femtocell 1004, the smart device 1005, and the connected personal assistant 1007 may be arranged with a respective optional user interface. The user interface may be formed as a multimedia interface for unidirectional or bidirectional transfer of one or more types of multimedia information (e.g., video, audio, tactile, etc.). Via the respective user interfaces of one or more of the femtocell 1004, the smart device 1005, and the connected personal assistant 1007, a patient ( Figure 22 (not shown) or a colleague of the patient ( Figure 22 (not shown) may input additional data to supplement the data collected by the sensing attachment 1002. For example, the user may input personal descriptive information (e.g., age change, weight change), changes in medical conditions, comorbidities, pain levels, quality of life, an indication of how the sensing attachment 1002 "feels", or other subjective metric data, personal information of medical practitioners, etc. In these embodiments, the personal descriptive information may be input using a keyboard, mouse, touch screen, microphone, wired or wireless computing interface, or some other input device. In cases where personal descriptive information is collected, the personal descriptive information may include or otherwise be associated with one or more identifiers that associate the information with the sensing attachment 1002, the patient, the relevant medical practitioner, the associated medical institution, etc.

[0551] In some of these cases, the respective optional user interfaces of each of one or more of the femtocell 1004, the smart device 1005, and the connected personal assistant 1007 may also be arranged to convey information associated with the sensing attachment 1002 to a user, such as from a medical practitioner. In these cases, the information conveyed to the user may be transmitted via a video screen, an audio output device, a tactile transducer, a wired or wireless computing interface, or some other similar means.

[0552] In embodiments where a user interface is arranged in one or more of the femtocell 1004, smart device 1005, and connected personal assistant 1007, the user interface may be formed with an internal user interface arranged for communicatively coupling to a patient portal device. The patient portal device may be a smart phone, tablet, wearable device, weight or other health measurement device (e.g., thermometer, bathroom scale, etc.), or some other computing device capable of wired or wireless communication. In these cases, the user is able to input personal descriptive information, and the user may also be able to receive information associated with the sensing attachment 1002.

[0553] The femtocell 1004 uses the patient's home network 1006 to transmit the collected data to the cloud 1008. The home network 1006, which may be a local area network, provides access from the patient's home to a wide area network such as the Internet. In some embodiments, the femtocell 1004 may use a Wi-Fi connection to connect to the home network 1006 and access the Internet. In other embodiments, the femtocell 1004 may connect to the patient's home computer ( Figure 22 (not shown in the figure), such as via a USB connection, which itself is connected to the home network 1006.

[0554] The smart device 1005 may communicate directly with the sensing attachment 1002 via a signal such as a compatible Bluetooth (Blue ) signal, and may use the patient's home network 1006 to transmit the collected data to the cloud 1008, or may communicate directly with the cloud, e.g., via a cellular network. Alternatively, the smart device 1005 is configured to communicate directly with one or both of the femtocell 1004 and the connected personal assistant 1007 via a signal such as a compatible Bluetooth signal, and is not configured to communicate directly with the sensing attachment 1002.

[0555] In addition, the connected personal assistant 1007 may communicate directly with the sensing attachment 1002 via a signal such as a compatible Bluetooth (Blue ) signal, and may use the patient's home network 1006 to transmit the collected data to the cloud 1008, or may communicate directly with the cloud, e.g., via a modem / Internet connection or a cellular network. Optionally, the connected personal assistant 1007 is configured to communicate directly with one or both of the femtocell 1004 and the smart device 1005 via a signal such as a compatible Bluetooth signal, and is not configured to communicate directly with the sensing attachment 1002.

[0556] In addition to transmitting the data to be collected to cloud 1008, one or more of the home base station 1004, the smart device 1005, and the connected personal assistant 1007 may also obtain data, commands, or other information from cloud 1008 directly or via the home network 1006. One or more of the home base station 1004, the smart device 1005, and the connected personal assistant 1007 may provide some or all of the received data, commands, or other information to the sensing attachment 1002. Examples of such information include, but are not limited to, updated configuration information, diagnostic requests to determine whether the sensing attachment 1002 is operating properly, data collection requests, and other information.

[0557] Cloud 1008 may include one or more server computers or databases to aggregate the data collected from the sensing attachment 1002, and in some cases the personal descriptive information collected from the patient ( Figure 22 not shown), as well as data collected from other sensing attachments (not shown), and in some cases personal descriptive information collected from other patients. In this way, cloud 1008 may create various different metrics regarding the data collected from each of the multiple sensing attachments implanted into separate patients. This information may help determine whether the sensing attachment is working properly. The information collected may also be helpful for other purposes, such as determining which specific devices may not be operating properly, determining whether the procedures or conditions associated with the sensing attachment are helpful to the patient (e.g., whether the stent graft is operating properly), and determining other medical information.

[0558] Still referring to Figure 22, alternative embodiments are envisioned. For example, one or two of the femtocell 1004, smart device 1005, and connected personal assistant 1007 may be omitted from the sensing attachment environment 1000. Additionally, each of the femtocell 1004, smart device 1005, and connected personal assistant 1007 may be configured to communicate with one or two of the sensing attachment 1002 and the cloud 1008 via one or two of the femtocell, smart device, and connected personal assistant. Further, the smart device 1005 may be temporarily shrunk to an interface of the sensing attachment 1002 and may be any suitable device other than a smartphone, such as a smartwatch, smart patch, and any IoT device, such as a coffee pot, that can act as an interface of the sensing attachment 1002. Additionally, one or more of the femtocell 1004, smart device 1005, and connected personal assistant 1007 may act as a communication hub for multiple sensing attachments implanted in one or more patients. Additionally, if a healthcare professional and an insurance company have pre-authorized such an order or reorder, one or more of the femtocell 1004, smart device 1005, and connected personal assistant 1007 may automatically order or reorder a prescription or medical supply in response to a patient input or a sensing attachment input (e.g., pain level, instability level); optionally, one or more of the base station, smart device, and connected personal assistant may be configured to request authorization to place an order or reorder from a healthcare professional or an insurance company. Additionally, one or more of the femtocell 1004, smart device 1005, and connected personal assistant 1007 may be configured with a personal assistant, such as or

[0559] Although the sensing attachment environment has been described in the patient's home, the same principles apply when the environment is an operating room or a doctor's office. For example, in association with a medical procedure, the sensing attachment 1002 may be implanted in a patient within an operating room environment. Synchronized with the medical process, the sensing attachment 1002 communicates with an operating room base station (similar to a femtocell). Subsequently, after fully recovering from the medical procedure, the patient returns home, where the sensing attachment 1002 is arranged to communicate with the femtocell 1004. Thereafter, at other times, when the patient goes to see a doctor for a follow-up consultation, the sensing attachment 1002 is arranged to communicate with a doctor's office base station. In any case, the sensing attachment 1002 communicates with each base station via a short-range network protocol, such as Medical Implant Communication Service (MICS), Medical Device Radio Service (MedRadio), or some other wireless communication protocol suitable for use with the sensing attachment 1002.

[0560] For example, implanting the sensing attachment 1002 into a patient can occur in an operating room. As used herein, an operating room includes any office, room, building, or facility in which the sensing attachment 1002 is implanted into a patient. For example, the operating room can be a typical operating room in a hospital, an operating room in a surgical clinic or a doctor's office, or any other operating room in which the sensing attachment 1002 is implanted into a patient.

[0561] An operating room base station (similar to Figure 22 the home base station) is used to configure and initialize the sensing attachment 1002 associated with the sensing attachment 1002 implanted in a patient. A communication relationship is formed between the sensing attachment 1002 and the operating room base station, for example, based on a polling signal sent by the operating room base station and a response signal sent by the sensing attachment 1002.

[0562] When forming the communication relationship that typically occurs before implanting the sensing attachment 1002, the operating room base station sends initial configuration information to the sensing attachment 1002. The initial configuration information can include, but is not limited to, a timestamp, a date stamp, an identification of the type and location of the sensing attachment 1002, information about other implants associated with the sensing attachment, surgeon information, patient identification, operating room information, and the like.

[0563] In some embodiments, the initial configuration information is passed unidirectionally; in other embodiments, the initial configuration is passed bidirectionally. The initial configuration information can define at least one parameter associated with data collection by the sensing attachment 1002. For example, for each of one or more operating modes, the configuration information can identify settings of one or more sensors on the sensing attachment 1002. The configuration information can also include other control information, such as the initial operating mode of the sensing attachment 1002, a specific event that triggers a change in the operating mode, radio settings, data collection information (e.g., how often the sensing attachment 1002 wakes up to collect data, the time at which it collects data, the amount of data collected), identification information for the home base station 1004, the smart device 1005, and the connected personal assistant 1007, and other control information related to the implantation or operation of the sensing attachment 1002. Examples of the connected personal assistant 1007, also referred to as a smart speaker, include Amazon Amazon Google patient monitors, Comcast’s health tracking speaker, and Apple

[0564] In some embodiments, the configuration information may be pre-stored on the operating room base station or an associated computing device. In other embodiments, a surgeon, surgical technician, or some other medical practitioner may input control information and other parameters into the operating room base station for transmission to the sensing attachment 1002. In at least one such embodiment, the operating room base station may communicate with an operating room configuration computing device. The operating room configuration computing device includes an application with a graphical user interface that enables a medical practitioner to input configuration information for the sensing attachment 1002. In various embodiments, the application executed on the operating room configuration computing device may have some predefined configuration information that may or may not be adjustable by the medical practitioner.

[0565] The operating room configuration computing device transmits the configuration information to the operating room base station via a wired or wireless network connection (e.g., via a USB connection, Bluetooth connection, Bluetooth Low Energy (BTLE) connection, or Wi-Fi connection), which in turn transmits it to the sensing attachment 1002.

[0566] The operating room configuration computing device may also display information about the sensing attachment 1002 or the operating room base station to the surgeon, surgical technician, or other medical practitioner. For example, if the sensing attachment 1002 is unable to store or access configuration information, if the sensing attachment 1002 is unresponsive, if the sensing attachment 1002 identifies a problem with one of the sensors or radios during an initial self-test, if the operating room base station is unresponsive or malfunctioning, or for other reasons, the operating room configuration computing device may display an error message.

[0567] Although the operating room base station and the operating room configuration computing device are described as separate devices, the embodiments are not so limited; rather, the functions of the operating room configuration computing device and the operating room base station may be included in a single computing device or in separate devices as shown. In this manner, in one embodiment, a medical practitioner may be able to input configuration information directly into the operating room base station.

[0568] After the sensing attachment is implanted in a patient, the patient may periodically visit a doctor's office for follow-up evaluations. On one hand, the present disclosure provides a doctor's office environment (similar to the home environment described herein) in which the implanted sensing attachment communicates with the office environment. During these visits, as part of the monitoring process, data that has been stored in the memory may be accessed, and / or specific data may be requested and obtained.

[0569] For example, at different times during the entire monitoring process, the patient may be required to see a practicing physician for a follow-up appointment. The healthcare practitioner may be the surgeon who implanted the sensing attachment 1002 into the patient or a different practicing physician who oversees the patient's monitoring process, physical therapy, and rehabilitation. For various different reasons, the practicing physician may wish to collect real-time data from the sensing attachment 1002 in a controlled environment. In some cases, requests to access the practicing physician can be conveyed through the respective optional bi-directional user interfaces of one or more of the home base station 1004, the smart device 1005, and the connected personal assistant 1007.

[0570] The practicing physician utilizes a physician's office base station that communicates with the sensing attachment 1002 (similar to Figure 22 the home base station shown) to transfer additional data between the physician's office base station and the sensing attachment 1002. Optionally or additionally, the practicing physician utilizes the physician's office base station ( Figure 22 not shown) to pass commands to the sensing attachment 1002. In some embodiments, the physician's office base station instructs the sensing attachment 1002 to enter a high-resolution mode to temporarily increase the rate or type of data collected over a short period of time. The high-resolution mode directs the sensing attachment 1002 to collect a different (e.g., large) amount of data while the healthcare practitioner is also monitoring the patient's activities.

[0571] In some embodiments, the physician's office base station enables the practicing physician to input events or pain markers, which can be synchronized with the high-resolution data collected by the sensing attachment 1002. For example, when the sensing attachment 1002 is in high-resolution mode, the practicing physician may have the patient walk on a treadmill. While the patient is walking, the patient may complain of pain. The practicing physician can click a pain marker button on the physician's office base station to indicate the patient's discomfort. The physician's office base station records the marker and the time the marker was entered. When the time of the marker is synchronized with the time of the high-resolution data collected, the practicing physician can analyze the data to attempt to determine the cause of the pain.

[0572] In other embodiments, the doctor's office base station can provide updated configuration information to the sensing attachment 1002. The sensing attachment 1002 can store the updated configuration information, which can be used to adjust parameters associated with data collection. For example, if the patient is in good condition, the practitioner can direct a reduction in the frequency of data collection by the sensing attachment 1002. Conversely, if the patient is experiencing an unexpected amount of pain, the practitioner can instruct the sensing attachment 1002 to collect additional data for a defined period (e.g., several days). The practitioner can use the additional data to diagnose and treat a particular problem. In some cases, the additional data can include personal descriptive information provided by the patient after the patient has left the presence of the practitioner and is no longer within the range of the doctor's office base station. In these cases, the personal descriptive information can be collected and transmitted via one or more of the home base station 1004, the smart device 1005, and the connected personal assistant 1007. Firmware within the sensing attachment and / or the base station will provide safeguards to limit the duration of such enhanced monitoring to ensure that the sensing attachment 1002 maintains sufficient power to last the life cycle of the implant.

[0573] In various embodiments, the doctor's office base station can communicate with a doctor's office configuration computing device (similar to the operating room computing device). The doctor's office configuration computing device includes an application with a graphical user interface that enables the practitioner to input commands and data. Some or all of the commands, data, and other information can later be transmitted via the doctor's office base station to the sensing attachment 1002. For example, in some embodiments, the practitioner can use the graphical user interface to instruct the sensing attachment 1002 to enter its high-resolution mode. In other embodiments, the practitioner can use the graphical user interface to input or modify the configuration information of the sensing attachment 1002. The doctor's office configuration computing device transmits information (e.g., commands, data, or other information) to the doctor's office base station via a wired or wireless network connection (e.g., via a USB connection, a Bluetooth connection, or a Wi-Fi connection), which in turn transmits some or all of the information to the sensing attachment 1002.

[0574] The doctor's office configuration computing device can also display to the practitioner information about the sensing attachment 1002, other information about the patient (e.g., personal descriptive information), or the doctor's office base station. For example, the doctor's office configuration computing device can display high-resolution data collected by the sensing attachment 1002 and transmitted to the doctor's office base station. The doctor's office configuration computing device can also display an error message if the sensing attachment 1002 is unable to store or access configuration information, if the sensing attachment 1002 is unresponsive, if the sensing attachment 1002 identifies a problem with one of the sensors or radios, if the doctor's office base station is unresponsive or malfunctioning, or for other reasons.

[0575] In some embodiments, a doctor's office configured computing device can access Cloud 1008. In at least one embodiment, a practicing physician can use the doctor's office configured computing device to access data stored in Cloud 1008 that was previously collected by the sensing attachment 1002 and transmitted to Cloud 1008 via one or both of the home base station 1004 and the smart device 1005. Similarly, the doctor's office configured computing device can transmit high-resolution data obtained from the sensing attachment 1002 to Cloud 1008 via the doctor's office base station. In some embodiments, the doctor's office base station can have Internet access and may be able to directly transmit high-resolution data to Cloud 1008 without using the doctor's office configured computing device.

[0576] In various embodiments, when the patient is not in the practicing physician's office, the practicing physician can update the configuration information of the sensing attachment 1002. In these cases, the practicing physician can use the doctor's office configured computing device ( Figure 22 not shown) to transmit the updated configuration information to the sensing attachment 1002 via Cloud 1008. One or more of the home base station 1004, the smart device 1005, and the connected personal assistant 1007 can obtain the updated configuration information from Cloud 1008 and transmit the updated configuration information to the cloud. This can allow the practicing physician to remotely adjust the operation of the sensing attachment 1002 without the patient coming to the practicing physician's office. This can also allow the practicing physician to send a message to the patient in response to, for example, personal description information provided by the patient and passed through one or more of the home base station 1004, the smart device 1005, and the personal assistant 1007 connected to the doctor's office base station ( Figure 22 not shown). For example, if the patient says to the connected personal assistant 1007 "I am in pain", the practicing physician can prescribe pain medication and have the connected personal assistant "say" "The doctor has sent a prescription to your preferred pharmacy; you can pick up the prescription at 4 PM" to notify the patient. prescription; you can pick up the prescription at 4 PM" to notify the patient.

[0577] Although the doctor's office base station ( Figure 22 not shown) and the doctor's office configured computing device ( Figure 22 not shown) are described as separate devices, the embodiments are not so limited; rather, the functions of the doctor's office configured computing device and the doctor's office base station can be included in a single computing device or separate devices (as shown). In this way, in one embodiment, the practicing physician can be enabled to directly input configuration information or markings into the doctor's office base station and view high-resolution data (and synchronized marking information) on a display on the doctor's office base station.

[0578] In one embodiment, the sensor communication, activation, and functionality of the communication and power components will be similar to those described in PCT Publication WO2017165717. This provides the advantage of being able to collect and monitor a range of useful information related to EVAR and the patient's general condition to manage the patient's health. The frequency of data collection is based on a power optimization algorithm, taking into account the required data frequency, size limitations related to battery technology, memory size, and the power requirements of all components (such as IMU, memory, sensors, radio). The information includes but is not limited to: battery charge level; implantation duration; traceability; implant serial number; acute and chronic measurements, including intracapsular pressure, arterial pressure at multiple locations, hemodynamic parameters such as CO concentration, blood flow, heart rate; and activity measurements such as steps and distance. Additionally, the present disclosure optionally provides integration of patient input data such as BMI, comorbidities, medications, pain, and quality of life metrics.

[0579] It should be noted that not all data can be collected at every time interval. Similarly, it should be noted that the above-mentioned acute and chronic measurements may only need to be collected for a few seconds within any time interval. It is also stipulated that if the aneurysm sac pressure measurement or other measurements indicate a signal, the patient will be directed to a clinician for further evaluation via an interface connecting the patient to their clinician.

[0580] In one embodiment, the present disclosure provides a released signal that is released from a sensor and contains information sensed by the sensor. In another embodiment, the present disclosure provides for the capture of the released signal, where the capture can occur near the sensor or at a remote location. In yet another embodiment, the present disclosure provides for the processing of the released signal, where the released signal is processed to provide useful information.

[0581] The present disclosure provides a sensor and construct that is separable from a medical device such as a graft, such that no physical modification to the medical device (such as the graft) is required to enable the medical device to have sensing capabilities. The design is actually universal for obtaining hemodynamic measurements of any arterial vessel using laparoscopic or open surgical implantation methods with percutaneously or extravascularly placed sensors. For example, a system such as that described herein can be placed proximal and / or distal to a coronary stent to determine when an occlusion occurs, thereby alerting the patient and clinician for intervention before an emergency situation arises. Depending on the placement of the sensor, the present invention can be used to monitor hemodynamics and pressure related to secondary comorbidities such as hypertension using algorithms that range from local vascular pressure measurements to systemic pressure measurements for real-time diagnostic purposes. The latter allows the patient / clinician to titrate medications to control their hypertension.

[0582] In an embodiment, the present disclosure provides: a sensor including a housing that surrounds a detector, the housing including an extension that allows the sensor to be fixedly attached to a support; a construct including the sensor fixedly attached to a support, where the support can be firmly engaged with a medical device; an assembly including the sensor, a support of the sensor, and a medical device, where the sensor is in direct contact with and fixedly attached to the support, and where the support is in direct contact with and firmly engaged with the medical device, where optionally, the sensor is not in direct contact with the medical device.

[0583] The following are exemplary numbered embodiments according to the present disclosure:

[0584] 1) A sensor including a housing that surrounds a detector, the housing including an extension that allows the sensor to be fixedly attached to a support.

[0585] 2) A construct including the sensor fixedly attached to a support, where the support can be firmly engaged with a medical device.

[0586] 3) A front view of an assembly including the sensor, a support of the sensor, and a medical device, where the sensor is in direct contact with and fixedly attached to the support, and where the support is in direct contact with and firmly engaged with the medical device.

[0587] 4) The sensor of embodiment 1, which is sterile.

[0588] 5) The construct of embodiment 2, which is sterile.

[0589] 6) The assembly of embodiment 3, which is sterile.

[0590] 7) The sensor of embodiment 1, where the detector detects one of pressure, temperature, motion, and acceleration.

[0591] 8) The construct of embodiment 2, where the sensor detects one of pressure, temperature, motion, and acceleration.

[0592] 9) The assembly of embodiment 3, where the sensor detects one of pressure, temperature, motion, and acceleration.

[0593] 10) The sensor of embodiment 1, where the detector is a non-biological sensor.

[0594] 11) The construct of embodiment 2, where the sensor is a non-biological sensor.

[0595] 12) The assembly of embodiment 3, where the sensor is a non-biological sensor.

[0596] 13) The sensor of Embodiment 1, which comprises a medical-grade material.

[0597] 14) The construct of Embodiment 2, which comprises a medical-grade material.

[0598] 15) The assembly of Embodiment 3, which comprises a medical-grade material.

[0599] 16) The sensor of Embodiment 1, wherein the sensor comprises a housing, and the housing comprises a material selected from metal and polyetheretherketone.

[0600] 17) The construct of Embodiment 2, wherein the sensor comprises a housing, and the housing comprises a material selected from metal and polyetheretherketone.

[0601] 18) The construct of Embodiment 3, wherein the sensor comprises a housing, and the housing comprises a material selected from metal and polyetheretherketone.

[0602] 19) The construct of Embodiment 2, wherein the support member comprises a material selected from metal (such as nitinol) and polyetheretherketone.

[0603] 20) The assembly of Embodiment 3, wherein the support member comprises a material selected from metal (such as nitinol) and polyetheretherketone.

[0604] 21) The assembly of Embodiment 3, wherein the medical device is an implantable medical device.

[0605] 22) The construct of Embodiment 2, which comprises a plurality of sensors (for example, 2 - 10 sensors)

[0606] 23) The construct of Embodiment 22, wherein the plurality of sensors are in direct contact with the support member.

[0607] 24) The assembly of Embodiment 3, which comprises a plurality of sensors (for example, 2 - 10 sensors).

[0608] 25) The assembly of Embodiment 24, wherein the plurality of sensors are in direct contact with the support member.

[0609] 26) The assembly of Example 3, wherein the medical device comprises a guide rail, and the sensor is fixedly attached to the guide rail.

[0610] 27) The sensor of Embodiment 1, wherein the sensor comprises any one or more of a battery, a memory, a radio, an antenna, and an inertial measurement unit (IMU).

[0611] 28) The construct of Embodiment 2, wherein the sensor comprises any one or more of a battery, a memory, a radio, an antenna, and an inertial measurement unit (IMU).

[0612] 29) The assembly of Embodiment 3, wherein the sensor comprises any one or more of a battery, a memory, a radio, an antenna, and an inertial measurement unit (IMU).

[0613] 30) The sensor of Embodiment 1, wherein the sensor comprises a housing and the housing comprises an extension, and the extension comprises one or more holes.

[0614] 31) The construct of Embodiment 2, wherein the sensor comprises a housing and the housing comprises an extension, and the extension comprises one or more holes.

[0615] 32) The assembly of Embodiment 3, wherein the sensor comprises a housing and the housing comprises an extension, and the extension comprises one or more holes.

[0616] 33) The assembly of Embodiment 3, which comprises a plurality of supports, and each of the plurality of supports comprises a sensor

[0617] 34) The construct of Embodiment 2, wherein the support is in the form of a cannula.

[0618] 35) The assembly of Embodiment 3, wherein the support is in the form of a cannula.

[0619] 36) A construct comprising a cannula, the cannula comprising a luminal side and an abluminal side, and the construct further comprises a sensor fixedly attached to the abluminal side of the cannula.

[0620] 37) The construct of Embodiment 36, wherein the cannula comprises a rail, and the sensor is fixedly attached to the rail.

[0621] 38) The construct of Embodiment 36, wherein the sleeve comprises nitinol.

[0622] 39) The construct of Embodiment 36, wherein the cannula is expandable according to the width of the cannula.

[0623] 40) The construct of Embodiment 36, wherein the sleeve is not a stent.

[0624] 41) The construct of Embodiment 36, wherein the cannula fits around a stent or a graft and firmly engages the stent or the graft.

[0625] 42) The construct of Embodiment 36, wherein the sleeve has a length of 1 to 3 millimeters.

[0626] 43) The construct of embodiment 36, comprising a plurality of sensors fixedly attached to the proximal side of the cannula.

[0627] 44) A method of forming a construct, wherein the construct comprises a sensor fixedly attached to a support, and wherein the support can be firmly engaged with a medical device; the method comprising: a) providing a sensor comprising a housing that surrounds a detector, the housing comprising an extension that permits the sensor to be fixedly attached to the support; b) forming a support that can be firmly engaged with a medical device; c) fixedly attaching the sensor to the support during the formation of the support.

[0628] 45) A method of forming a construct, wherein the construct comprises a sensor fixedly attached to a support, and wherein the support can be firmly engaged with a medical device; the method comprising: a) providing a sensor comprising a housing that surrounds a detector, the housing comprising an extension that permits the sensor to be fixedly attached to the support; b) providing a support that can be firmly engaged with a medical device; c) fixedly attaching the sensor to the support before firmly engaging the support with the medical device.

[0629] The present invention has been described herein in broad and general terms. Each narrower genus and sub-genus grouping falling within the general disclosure also forms part of the present invention. This includes the general description of the present invention, with the proviso or negative limitation of removing any subject matter from the dependent, whether or not the excised material is specifically recited herein.

[0630] It should also be understood that, as used herein and in the appended claims, the singular forms "a", "an", and "the" include plural referents, unless the context clearly dictates otherwise, the term "X and / or Y" means "X" or "Y" or "X" and "Y", and the letter "s" following a noun denotes both the plural and singular forms of that noun. Additionally, in the case of describing features or aspects of the present invention in terms of a Markush group, it is intended and will be recognized by those skilled in the art that the present invention includes and is thus also described in terms of any single member and any subgroup of members of the Markush group, and the applicant reserves the right to amend the application or claim specifically to any single member or any subgroup of members of the Markush group.

[0631] All references disclosed herein, including patent references and non-patent references, are hereby incorporated by reference in their entirety as if each reference were incorporated individually. For example, PCT Publication No. WO 2017 / 165717 is incorporated herein for all purposes, including for disclosing how to power a sensor as disclosed herein; and how to permit transmission of information obtained by a sensor as disclosed herein to outside the patient who has received the sensor.

[0632] It should be understood that the terms used herein are for the purpose of describing particular embodiments only and are not intended to be limiting. It should also be understood that unless specifically defined herein, the terms used herein will be given their conventional meanings known in the relevant art.

[0633] References throughout this specification to "one embodiment" or "an embodiment" and variations thereof mean that a particular feature, structure, or characteristic described in connection with that embodiment is included in at least one embodiment. Thus, the phrases "in one embodiment" or "in an embodiment" that appear in different places in this specification do not necessarily all refer to the same embodiment. Furthermore, the particular features, structures, or characteristics may be combined in any suitable manner in one or more embodiments.

[0634] As used in this specification and the appended claims, the singular forms "a", "an", and "the" include plural referents, i.e., one or more, unless the context and content clearly indicate otherwise. For example, the term "a sensor" refers to one or more sensors, and the term "a medical device including a sensor" refers to a medical device including at least one sensor, where the medical device including a sensor may have, for example, 1 sensor, 2 sensors, 3 sensors, 4 sensors, 5 sensors, 6 sensors, 7 sensors, 8 sensors, 9 sensors, 10 sensors, or more than 10 sensors. A plurality of sensors means more than one sensor. It should also be noted that the conjunctive terms "and" and "or" are generally used in their broadest sense to include "and / or", unless the context and content specifically dictate inclusively or exclusively as the case may be. Thus, the use of an alternative (e.g., "or") should be understood to mean any one of the alternatives, both, or any combination thereof. Additionally, the combination of "and" and "or" when referred to herein as "and / or" is intended to cover embodiments that include all relevant items or ideas, as well as one or more other alternative embodiments that include less than all relevant items or ideas.

[0635] Unless the context requires otherwise, throughout the specification and the following claims, the word "comprise" and its synonyms and variations, such as "have" and "include", and its variations, such as "comprises" and "comprising", shall be construed in an open, inclusive sense, such as "including but not limited to". The term "consisting essentially of" limits the scope of a claim to the specified materials or steps, or those that do not materially affect the underlying and novel characteristics of the claimed invention.

[0636] Any headings used in this document are for the sole purpose of expediting the reader's review and should not be construed as limiting the invention or the claims in any way. Accordingly, the headings and abstracts of the present disclosure provided herein are for convenience only and do not interpret the scope or meaning of the embodiments.

[0637] Where ranges of values are provided herein, it is to be understood that each intermediate value, to the tenth of the unit of the lower limit, unless the context clearly dictates otherwise, between the upper and lower limits of that range and any other stated or intermediate value within that stated range, is included in the invention. The upper and lower limits of these smaller ranges may independently be included in the smaller ranges and also in the invention, subject to any specific exclusions stated within the range. Where the stated range includes one or both of the limits, ranges excluding either one or both of those included limits are also included in the invention.

[0638] For example, any concentration range, percentage range, ratio range or integer range provided herein shall be understood to include any integer values within the stated range and, where appropriate, fractions thereof (such as one-tenth and one-hundredth of an integer), unless otherwise stated. Moreover, unless otherwise stated, any numerical range recited herein relating to any physical characteristic, such as polymer subunits, size or thickness, shall be understood to include any integer within the stated range. As used herein, unless otherwise stated, the term "about" means ±20% of the stated range, value or structure.

[0639] All U.S. patents, U.S. patent application publications, U.S. patent applications, foreign patents, foreign patent applications, and non-patent publications mentioned in this specification and / or listed in the application data sheet are hereby incorporated by reference in their entirety. These documents may be incorporated by reference for the purpose of describing and disclosing, for example, the materials and methods described in the publications, which may be used in conjunction with the presently described invention. The publications discussed above and throughout the document are provided only for their disclosure prior to the filing date of the present application. Nothing herein is to be construed as an admission that the inventors are not entitled to antedate any reference publication by virtue of prior invention.

[0640] All patents, publications, scientific articles, websites, and other documents and materials cited or mentioned herein are indicative of the level of skill of those of ordinary skill in the art to which the present invention pertains, and each such cited document and material is hereby incorporated by reference into this application to the same extent as if it were individually incorporated by reference in its entirety or set forth in its entirety herein. The applicant reserves the right to actually incorporate into this specification any and all materials and information from any such patents, publications, scientific articles, websites, electronically available information, and other reference materials or documents.

[0641] Generally, in the following claims, the terms used should not be construed as limiting the claims to the specific embodiments disclosed in the specification and claims, but should be construed to include all possible embodiments and the full scope of all equivalents of such claims. Accordingly, the claims are not limited by the present disclosure.

[0642] Furthermore, the written description portion of this patent includes all claims. Additionally, all claims, including all original claims and all claims from any and all priority documents, are hereby incorporated by reference in their entirety into the written description portion of the specification, and the applicant reserves the right to materially incorporate the application, the written description of any and all such claims, or any other portion thereof. Accordingly, for example, in no event may a patent be construed as failing to provide a written description of a claim based on a claim that the exact wording of the claim is not set forth in such words in the written description portion of the patent.

[0643] The claims will be construed in accordance with the law. However, and notwithstanding any claim or perception of ease or difficulty in construing any claim or portion thereof, in no event will any adjustment or modification of a claim or any portion thereof during the examination of one or more applications result in this patent being construed as having lost any right to any and all equivalents thereof that do not form part of the prior art.

[0644] Other non-limiting embodiments are within the following claims. The patent may not be construed as limited to the specific examples or non-limiting embodiments or methods specifically and / or expressly disclosed herein. In no event may the patent be construed as being limited by any statement made by any examiner or any other officer or employee of the Patent and Trademark Office, unless such statement is specifically adopted in the applicant's response in writing and without limitation or reservation.

Claims

1. A sensing attachment for a medical device, the attachment comprising: a) a sensor; b) a communication interface configured to provide in-vivo communication to another device; and at least one of the following: i) an elastic or super-elastic body having a shape conforming around a tubular medical device, wherein the body is not integrated with the tubular medical device; and ii) a body in the form of a spring made of nitinol, conforming around a tubular medical device, wherein the body is not integrated with the tubular medical device; wherein the body is in the form of a hollow monofilament comprising nitinol, wherein the hollow monofilament has a lumen surrounded by the wall of the hollow monofilament, wherein the wall has an inner surface facing the lumen and an outer surface facing away from the lumen, and wherein the hollow monofilament has a plurality of incisions along its length, each incision extending from the outer surface of the hollow monofilament into the lumen of the hollow monofilament.

2. The sensing attachment according to claim 1, wherein the body is in the form of a hollow monofilament comprising nitinol, wherein the hollow monofilament has a lumen surrounded by the wall of the hollow monofilament, wherein the wall has an inner surface facing the lumen and an outer surface facing away from the lumen, and wherein the hollow monofilament has a plurality of incisions along its length, each incision extending from the outer surface of the hollow monofilament into the lumen of the hollow monofilament, wherein the plurality of incisions are spaced 1-20 mm apart from each other.

3. The sensing attachment according to claim 1, wherein the body is in the form of a plurality of rings.

4. The sensing attachment according to claim 1, wherein the body is in the form of a spring.

5. The sensing attachment according to claim 1, wherein the body is in the form of a spring wound in a clockwise direction.

6. The sensing attachment according to claim 1, wherein the body is in the form of a spring wound in a counterclockwise direction.

7. The sensing attachment according to claim 1, wherein the body is in the form of a clip.

8. The sensing attachment according to claim 1, wherein the body is annular.

9. The sensing attachment according to claim 1, wherein the body comprises a hollow monofilament in the form of a spring.

10. The sensing attachment according to claim 1, wherein the body is in the form of a clip or a cuff bracelet.

11. The sensing attachment according to claim 1, wherein the sensing attachment is biocompatible.

12. The sensing attachment according to claim 1, wherein the body is elastic or super-elastic.

13. The sensing attachment according to claim 1, wherein the body comprises a shape memory material.

14. The sensing attachment according to claim 1, wherein the body comprises an elastic plastic.

15. The sensing attachment according to claim 1, wherein the body has dimensions and a shape that allow it to conform to and abut against the outer surface of a stent graft.

16. The sensing attachment according to claim 1, wherein the body has dimensions and a shape that allow it to conform to and abut against the inner surface of a stent graft.

17. The sensing attachment according to claim 1, wherein the body has dimensions and a shape that permit it to conform to and abut an inner surface of a graft.

18. The sensing attachment according to claim 1, which is in a compressed form and is disposed inside a delivery catheter for percutaneous delivery to a patient.

19. The sensing attachment according to claim 1, wherein the body includes a polymeric coating on a surface of the body.

20. The sensing attachment according to claim 1, wherein the body includes a smooth coating on a surface of the body.

21. The sensing attachment according to claim 1, wherein a cuff is disposed around at least a portion of a surface of the body.

22. The sensing attachment according to claim 1, wherein the sensor is selected from the group consisting of a fluid pressure sensor, a fluid volume sensor, a contact sensor, a position sensor, a pulse pressure sensor, a blood flow sensor, a chemical sensor, an accelerometer, a mechanical stress sensor, and a temperature sensor.

23. The sensing attachment according to claim 22, wherein the sensor is selected from the group consisting of a blood volume sensor and a metabolic sensor.

24. The sensing attachment according to claim 1, wherein the sensor is a pressure sensor.

25. The sensing attachment according to claim 1, wherein the sensor is a plurality of pressure sensors.

26. The sensing attachment according to claim 1, wherein the sensor is a MEMS sensor.

27. The sensing attachment according to claim 1, wherein the sensor is hermetically sealed.

28. The sensing attachment according to claim 1, further comprising a power source.

29. The sensing attachment according to claim 1, further comprising a power source and an electronic assembly having various circuits powered by the power source, the electronic assembly including one or more components selected from the group consisting of a fuse, a switch, a clock generator, and a power management unit, a memory, and a controller.

30. The sensing attachment according to claim 1, wherein the communication interface includes a radio frequency transceiver and a filter coupled to an antenna.

31. The sensing attachment according to claim 1, wherein the communication interface includes a tissue conduction communication circuit coupled to a pair of electrodes.

32. The sensing attachment according to claim 1, wherein the communication interface includes a data sound circuit coupled to an acoustic transducer.

33. The sensing attachment according to claim 1, wherein the tubular medical device is a graft.

34. The sensing attachment according to claim 1, wherein the tubular medical device is a stent graft.

35. The sensing attachment according to claim 22, wherein the chemical sensor is a sensor for blood.

36. The sensing attachment according to claim 23, wherein the metabolic sensor is a sensor for blood.

37. A medical device kit, comprising the sensing attachment according to claim 1 and a stent graft.

38. A medical device kit, comprising the sensing attachment according to claim 1 and a graft.

39. A medical device system, comprising the sensing attachment according to claim 1 associated with a stent graft.

40. A medical device system, comprising the sensing attachment according to claim 1 associated with a graft.

41. A medical device apparatus comprising the sensing attachment of claim 1 located within a delivery catheter.

42. A medical device apparatus comprising a system and a delivery catheter, the system comprising the sensing attachment of claim 1 associated with a graft, the system being located within the delivery catheter.

43. A medical device apparatus comprising a system and a delivery catheter, the system comprising the sensing attachment of claim 1 associated with a stent graft, the system being located within the delivery catheter.

44. A medical device apparatus, which comprises: a) A delivery catheter having a proximal end and a distal end and having a lumen extending therethrough, the lumen having a length and a cross-sectional area; b) The sensing attachment of claim 1 in a compressed state, the compressed sensing attachment being entirely located within the lumen of the delivery catheter; c) A push rod slidably disposed within the lumen of the delivery catheter, the push rod being adjacent to the compressed sensing attachment rather than within the compressed sensing attachment; and d) A distally movable sheath covering a first portion of the length of the lumen of the delivery catheter, wherein the first portion of the lumen contains a first portion of the push rod and a first portion of the sensing attachment in a compressed state; wherein the slidably disposed push rod engages the distally movable sheath such that sliding of the push rod causes movement of the movable sheath, wherein the movement exposes the first portion of the compressed sensing attachment and thereby allows the compressed sensing attachment to assume a lesser compressed form.

45. A method of manufacturing the sensing attachment of claim 1, comprising: a) Forming a body of the sensing attachment, wherein the body is at least one of the following: i) An elastic or superelastic body having a shape conforming to the periphery of a tubular medical device, wherein the body is not integrated with the tubular medical device; and ii) A body in the form of a spring formed of nitinol, having a shape conforming to the periphery of a tubular medical device, wherein the body is not integrated with the tubular medical device; b) Forming an electronic assembly including a sensor and a communication interface; c) Forming a power source; d) Electrically coupling and fixedly attaching the power source to the electronic assembly; and e) Fixedly attaching the electronic assembly and the power source to the body of the sensing attachment.

46. The method of claim 45, wherein the body is formed by shaping nitinol filaments.

47. The method of claim 45, wherein the body is in the form of a spring having a shape conforming to the periphery of a stent graft and maintaining dimensions and a shape against the outer surface of the stent graft by hoop stress.

48. The method of claim 45, wherein the body is in the form of a spring having a shape conforming to the inside of a stent graft and maintaining dimensions and a shape against the inner surface of the stent graft by hoop stress.

49. The method of claim 45, wherein the tubular medical device is a graft.

50. The method of claim 45, wherein the tubular medical device is a stent graft.

51. A method of associating a sensing attachment with a medical device in a safe manner in vitro, the method comprising: a) Select a medical device as a graft, wherein the medical device has an inner diameter and an outer diameter; b) Select the sensing attachment of claim 1 having an inner diameter and an outer diameter, wherein the inner diameter of the sensing attachment is substantially the same as the outer diameter of the medical device; c) Place the sensing attachment outside the medical device in vitro, wherein circumferential stress secures the sensing attachment to the medical device.

52. A method of associating a sensing attachment with a medical device in a safe manner in vitro, the method comprising: a) Select a medical device as a graft, wherein the medical device has an inner diameter and an outer diameter; b) Select the sensing attachment of claim 1 having an inner diameter and an outer diameter, wherein the outer diameter of the sensing attachment is substantially the same as the inner diameter of the medical device; c) Place the sensing attachment inside the medical device in vitro, wherein circumferential stress secures the sensing attachment to the medical device.

53. A method of manufacturing a system comprising a medical device having a sensing attachment located therein, the method comprising: a) Provide a medical device as a graft, the medical device having an interior and an exterior; b) Determine the inner diameter of the medical device; c) Select a sensing attachment of claim 1 having an interior and an exterior, the exterior having an outer diameter, wherein the outer diameter of the sensing attachment is substantially the same as the inner diameter of the medical device; d) Compress the sensing attachment from a non-compressed state to a compressed state, thereby reducing the inner diameter of the sensing attachment and placing the sensing attachment in a compressed state; e) Place the compressed sensing attachment at a location within the medical device having an inner diameter; f) Allow the sensing attachment to return to the non-compressed state such that the exterior of the sensing attachment contacts the interior of the medical device to provide a system comprising a medical device having a sensing attachment located within the medical device.

54. A method of manufacturing a system comprising a medical device and a sensing attachment located outside the medical device, the method comprising: a) Provide a medical device as a graft, the medical device having an inner surface and an outer surface; b) Select a sensing attachment of claim 1 having an interior and an exterior, the interior having an inner diameter, wherein the inner diameter of the sensing attachment is larger than the outer diameter of the medical device; and c) Place the sensing attachment around the medical device.

55. A non-diagnostic method for monitoring a patient, the method comprising: a) Obtain information using a sensor fixed to the sensing attachment of claim 1, the sensing attachment being physically associated with but not a component of a medical device implanted in a patient, the medical device being a graft; and b) Transmit the information or a modified form thereof to a device located outside the patient.

56. The method of claim 55, wherein the sensing attachment is associated with an abdominal aortic aneurysm stent graft.

57. The method of claim 55, wherein the sensor obtains characteristic information of the pressure within the aneurysm sac.

58. The method of claim 55, wherein the sensor obtains characteristic information of the pressure within a stent graft located within an abdominal aortic aneurysm of a patient.

59. The method according to claim 55, wherein the sensor is a plurality of sensors.

60. The method according to claim 55, wherein the sensor is a plurality of sensors located within an abdominal aortic aneurysm stent graft, and wherein the plurality of sensors obtain characteristic information of a first blood pressure at an inlet of the stent graft and characteristic information of a second blood pressure at an outlet of the stent graft.

61. The method according to claim 55, wherein the information is transmitted by radio frequency transmission from the sensing attachment.

62. The method according to claim 56, wherein the information is information regarding the presence or absence of endoleak associated with the implanted stent graft.

63. The method according to claim 56, wherein the information is information regarding the presence or absence of a partial obstruction of blood flowing through the stent graft.

64. The method according to claim 56, wherein the information is information regarding the presence or absence of a rupture within the stent graft.

65. The method according to any one of claims 51-55, wherein the graft is a stent graft.

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