Systems, methods and devices for embolic protection

Abstract

To provide a system, method and device for suitable embolic protection.SOLUTION: Embodiments of the present disclosure, in some embodiments, are directed to systems, methods and devices for providing embolic protection in a patient. For example, a medical device and an implantation method for implanting a medical device in a blood vessel of a subject are provided, for example comprising providing a medical device configured for arrangement in a blood vessel, the device comprising a filament, the filament being configured to include an undeployed state including a first device end (back) and a second device end (front) and at least a portion configured to fit in a lumen of a needle, and a deployed state in which the filament automatically forms helical turns in a first direction as seen from the first device end to the second device end, the helix optionally including at least one of a support portion and a filter portion.SELECTED DRAWING: Figure 1A

Description

[Technical Field]

[0001] (Related Applications) This application claims the benefit of and priority to U.S. Provisional Patent Application No. 63 / 037,382, entitled "Systems, Methods and Devices for Embolic Protection," filed June 10, 2020, the entire disclosure of which is incorporated herein by reference in its entirety.

[0002] FIELD OF THE DISCLOSURE The field of the disclosure is embolic protection devices. More particularly, the field of the disclosure is embolic protection for the prevention of stroke and / or pulmonary embolism. [Background technology]

[0003] (background) Embolism is the lodging of an embolus (a cut-off intravascular mass) in a narrow vessel, causing blockage of a portion of the body. Embolism can be classified as entering the arterial or venous circulation. Intra-arterial embolism can begin in the heart or aorta and can cause blockage and / or infarction in any part of the body. Lodging of an embolus in the brain from either the heart, aorta, or carotid artery can cause an ischemic stroke. Intravenous embolisms formed in systemic veins can lodge in the lungs after passing through the right side of the heart. This harmful condition is known as pulmonary embolism.

[0004] Distal embolism can occur spontaneously (especially in atrial fibrillation) or can be induced by manipulation of the heart, aorta, or veins, either during open surgery or during endovascular procedures such as balloon angioplasty, stent placement, or transcatheter valve replacement. Distal embolism can be prevented by pharmacological treatment (anticoagulants). While effective, anticoagulants have the adverse side effect of a high risk of bleeding, which can be serious or even life-threatening. In addition, many patients do not tolerate anticoagulant therapy well and are unable to enjoy the embolic protection it could provide.

[0005] Distal embolism can also be prevented by using mechanical filtering devices (distal embolic protection devices) placed between the embolic source and the distal vasculature. However, many prior and current devices do not adequately address the problem and, in fact, in many situations, cause problems (e.g., becoming occluded, migrating from the implantation site, and the like).

[0006] In some patients, distal embolism can be prevented by a combined approach involving both anticoagulants and mechanical filtering devices, which may be desirable in atrial fibrillation patients who have recently suffered a stroke event and need extra protection against recurrent embolic stroke. Summary of the Invention [Means for solving the problem]

[0007] (summary) Thus, embodiments of the present disclosure may be used to address embolic events within the body's blood vessels.

[0008] In some embodiments, a medical device configured for deployment within a blood vessel is provided, comprising a filament having a first device end (rear portion) and a second device end (front portion), and configured to include an undeployed state including at least a portion configured to fit within the lumen of a needle (and in some embodiments, substantially all or all of the filament), and a deployed state in which the filament automatically forms a helical winding in a first direction as viewed from the first device end to the second device end. In some embodiments, the helical winding may optionally include a support portion and a filter portion. The device is configured to be deployed within a blood vessel of a subject in an implantation orientation, such that the first device end points toward a first end of the subject and the second device end points toward a second end of the subject. The first direction of the filament corresponds to one of a clockwise or counterclockwise direction, depending on whether the device is deployed within a blood vessel disposed on a first side of a subject's body. The first direction of the filaments corresponds to the other of a clockwise or counterclockwise direction, depending on whether the device is deployed within a vessel on a second side of the subject's body.

[0009] In some embodiments, a medical device implantation method for implanting a medical device (such as one described above) into a blood vessel of a subject is described. The method includes providing a medical device configured for placement into a blood vessel, the device comprising a filament, the filament configured to include an undeployed state including a first device end (rear portion) and a second device end (front portion) and at least a portion configured to fit into the lumen of a needle (and in some embodiments, substantially all or all of the filament), and a deployed state in which the filament automatically forms a helical winding in a first direction as viewed from the first device end to the second device end (as described above, the helical winding optionally includes at least one of a support portion and a filter portion in some embodiments). The method also includes deploying the device into the blood vessel of the subject in an implantation orientation, whereby the first device end is oriented toward the first end of the subject and the second device end is oriented toward the second end of the subject. The first direction of the filaments corresponds to one of a clockwise or counterclockwise direction depending on whether the device is deployed in a blood vessel arranged on a first side of the subject's body, and the first direction of the filaments corresponds to the other of a clockwise or counterclockwise direction depending on whether the device is deployed in a blood vessel on a second side of the subject's body.

[0010] The foregoing embodiments (as well as other embodiments, see, e.g., embodiments in the Summary and Detailed Description below) may include one and / or another (in some embodiments, more than one, and in some embodiments, a majority, and in some embodiments, all) of the following additional structures, steps, functionality, and / or classifications, resulting in still further embodiments of the present disclosure: - the first side includes the left side of the subject's body and the second side includes the right side of the subject's body - Vessels on the left side of the body include the left carotid artery, and vessels on the right side of the body include the right carotid artery the distal end of the needle includes an opening and a bevel along a bevel plane; - The bevel plane is aligned so that it faces the midline of the subject during implantation - The bevel plane is aligned so that it faces the lateral direction of the subject during implantation - The bevel plane is aligned so that it faces the caudal direction of the subject during implantation - The bevel plane is aligned so that it faces the subject's head during implantation - The bevel plane is aligned so that it faces the subject's midline and faces the subject's caudal direction during implantation - The bevel plane is aligned so that it faces the subject's midline and faces the subject's head during implantation - The bevel plane is aligned so that it faces the lateral direction of the subject and faces the caudal direction of the subject during implantation - The bevel plane is aligned so that it faces the subject's lateral direction and faces the subject's cranial direction during implantation

[0011] In some embodiments, an embolic protection device (EPD) configured for deployment within a blood vessel is provided, comprising: an undeployed state including a first device end (rear portion) and a second device end (front portion), at least a portion thereof (and in some embodiments, substantially all or all thereof) configured to fit within the lumen of a needle; and a deployed state in which the filament automatically forms a helical winding in a first direction as viewed from the first device end to the second device end, the helical winding optionally including at least one of a support portion and a filter portion. An EPD is deployed in each carotid artery with a first end oriented cranially to the subject, the distal end of the needle including an opening and a bevel along a bevel plane, the bevel plane being aligned such that it faces both the midline and the caudal direction of the subject during implantation, and the first direction of the filament corresponding to a clockwise direction when the device is deployed in the right carotid artery, and the first direction of the filament corresponding to a counterclockwise direction when the device is deployed in the left carotid artery.

[0012] In some such embodiments, an embolic protection device system is provided that includes / provides, in addition to the aforementioned implantation device (e.g., an EPD device, or other filament-based medical device), a needle or catheter that is configured to house the EPD / medical device prior to implantation and to implant the EPD / medical device.

[0013] In some such embodiments, a method is provided for implanting an embolic protection device (EPD), the EPD having an undeployed state including a first device end (rear) and a second device end (leading), at least a portion thereof (and in some embodiments, substantially all or all thereof) configured to fit within the lumen of the needle, and a deployed state in which the filament automatically forms a helical winding in a first direction as viewed from the first device end to the second device end, the helical portion optionally including at least one of a support portion and a filter portion. The EPD is deployed within each carotid artery with the first end oriented cranially in the subject, and the distal end of the needle includes an opening and a bevel along the bevel plane. The bevel plane is aligned during implantation so that it faces both the midline and caudal direction of the subject, with the first direction of the filament corresponding to a clockwise direction when the device is deployed in the right carotid artery, and the first direction of the filament corresponding to a counterclockwise direction when the device is deployed in the left carotid artery.

[0014] These and other embodiments, as well as other objects and advantages of the invention disclosed herein, will become even more apparent by reference to the following detailed description and figures, a brief description of which follows. The present invention provides, for example, the following. (Item 1) 1. A medical device configured for placement within a blood vessel, the medical device comprising: a filament, the filament comprising: a first device end (rear) and a second device end (front); an undeployed state including at least a portion configured to fit within a lumen of a needle; a deployed state, wherein the filament automatically forms a helical winding in a first direction as viewed from the first device end to the second device end, the helical winding optionally including a support portion and a filter portion; configured to include the device is configured to be deployed in an implantation orientation within a blood vessel of a subject such that the first device end points toward a first end of the subject and the second device end points toward a second end of the subject; the first direction of the filaments corresponds to one of a clockwise or counterclockwise direction responsive to the device being deployed in a blood vessel disposed on a first side of the subject's body; A medical device, wherein the first direction of the filament corresponds to the other of the clockwise or counterclockwise direction depending on whether the device is deployed within a blood vessel on a second side of the subject's body. (Item 2) Item 10. The device of item 1, wherein the first side comprises a left side of the subject's body and the second side comprises a right side of the subject's body. (Item 3) Item 1, wherein the blood vessel on the left side of the body comprises the left carotid artery and the blood vessel on the right side of the body comprises the right carotid artery. (Item 4) 3. The device of item 2, wherein the blood vessel on the left side of the body comprises the left carotid artery and the blood vessel on the right side of the body comprises the right carotid artery. (Item 5) 5. The device of any of items 1-4, wherein the distal end of the needle includes an opening and a bevel along a bevel plane. (Item 6) Item 10. The device of item 1, wherein the distal end of the needle includes an opening and a bevel along a bevel plane. (Item 7) 7. The device of item 5 or 6, wherein the bevel plane is aligned such that it faces the midline of the subject during implantation. (Item 8) 7. The device of item 5 or 6, wherein the bevel plane is aligned such that it faces the lateral direction of the subject during implantation. (Item 9) 7. The device of claim 5 or 6, wherein the bevel plane is aligned such that it faces the caudal direction of the subject during implantation. (Item 10) 7. The device of claim 5 or 6, wherein the bevel plane is aligned such that it faces the cranial direction of the subject during implantation. (Item 11) 7. The device of claim 5 or 6, wherein the bevel plane is aligned during implantation such that it faces the midline of the subject and faces the caudal direction of the subject. (Item 12) 7. The device of claim 5 or 6, wherein the bevel plane is aligned such that it faces the midline of the subject and faces the cranial direction of the subject during implantation. (Item 13) 7. The device of claim 5 or 6, wherein the bevel plane is aligned such that during implantation it faces the lateral direction of the subject and faces the caudal direction of the subject. (Item 14) 7. The device of claim 5 or 6, wherein the bevel plane is aligned such that it faces a lateral direction of the subject and faces a cranial direction of the subject during implantation. (Item 15) 1. An embolic protection device (EPD) configured for placement within a blood vessel, the EPD comprising: a first device end (rear) and a second device end (front); an undeployed state including at least a portion configured to fit within a lumen of a needle; a deployed state in which the filament automatically forms a helical winding in a first direction as viewed from the first device end to the second device end, the helical winding optionally including at least one of a support portion and a filter portion; Equipped with the EPD is deployed in each carotid artery such that the first end is oriented cephalad to the subject; the distal end of the needle includes an opening and a bevel along a bevel plane; the bevel plane is aligned such that it faces both the midline and the caudal direction of the subject during implantation; a first direction of the filament corresponding to a clockwise direction in response to the device being deployed in the right carotid artery; The first direction of the filament corresponds to a counterclockwise direction in response to the device being deployed in the left carotid artery, EPD. (Item 16) 1. A medical implant system, comprising: a needle or catheter configured to house and implant a medical device prior to implantation; a medical device, which may comprise an embolic protection device (EPD); Equipped with The EPD is a first device end (rear) and a second device end (front); an undeployed state including at least a portion configured to fit within a lumen of a needle; a deployed state in which the filament automatically forms a helical winding in a first direction as viewed from the first device end to the second device end, the helical winding optionally including at least one of a support portion and a filter portion; Equipped with the device is deployed in each carotid artery such that the first end is oriented cephalad to the subject; the distal end of the needle includes an opening and a bevel along a bevel plane; the bevel plane is aligned such that it faces both the midline and the caudal direction of the subject during implantation; a first direction of the filament corresponding to a clockwise direction in response to the device being deployed in the right carotid artery; A medical implant system, wherein the first direction of the filament corresponds to a counterclockwise direction in response to the device being deployed within the left carotid artery. (Item 17) 1. A medical device implantation method for implanting a medical device into a blood vessel of a subject, comprising: A medical device configured for placement within a blood vessel is provided, the device comprising a filament, the filament comprising: a first device end (rear) and a second device end (front); an undeployed state including at least a portion configured to fit within a lumen of a needle; a deployed state in which the filament automatically forms a helical winding in a first direction as viewed from the first device end to the second device end, the helical winding optionally including at least one of a support portion and a filter portion; and deploying the device within the subject's vessel in an implantation orientation such that the first device end is directed toward a first end of the subject and the second device end is directed toward a second end of the subject; Including, the first direction of the filaments corresponds to one of a clockwise or counterclockwise direction responsive to the device being deployed in a blood vessel disposed on a first side of the subject's body; A method of implanting a medical device, wherein the first direction of the filament corresponds to the other of the clockwise or counterclockwise direction in response to the device being deployed in a blood vessel on a second side of the subject's body. (Item 18) Item 18. The method of item 17, wherein the first side comprises the left side of the subject's body and the second side comprises the right side of the subject's body. (Item 19) 19. The method of claim 17 or 18, wherein the blood vessel on the left side of the body comprises the left carotid artery and the blood vessel on the right side of the body comprises the right carotid artery. (Item 20) 20. The method of any of items 17-19, wherein the distal end of the needle includes an opening and a bevel along a bevel plane. (Item 21) 21. The method of claim 20, wherein the bevel plane is aligned such that it faces the midline of the subject during implantation. (Item 22) 21. The method of claim 20, wherein the bevel plane is aligned such that it faces the lateral direction of the subject during implantation. (Item 23) 21. The method of claim 20, wherein the bevel plane is aligned such that it faces the caudal direction of the subject during implantation. (Item 24) 21. The method of claim 20, wherein the bevel plane is aligned such that it faces the cranial direction of the subject during implantation. (Item 25) 21. The method of claim 20, wherein the bevel plane is aligned such that it faces the midline of the subject and faces the caudal direction of the subject during implantation. (Item 26) 21. The method of claim 20, wherein the bevel plane is aligned such that it faces the midline of the subject and faces the cranial direction of the subject during implantation. (Item 27) 21. The method of claim 20, wherein the bevel plane is aligned such that it faces the lateral direction of the subject and faces the caudal direction of the subject during implantation. (Item 28) 21. The method of claim 20, wherein the bevel plane is aligned such that it faces the lateral direction of the subject and faces the cranial direction of the subject during implantation. (Item 29) 1. An embolic protection device (EPD) implantation method for implanting an EPD in a blood vessel of a subject, comprising: 1. An EPD configured for placement within a blood vessel, the EPD comprising a filament, the filament comprising: a first device end (rear) and a second device end (front); an undeployed state including at least a portion configured to fit within a lumen of a needle; a deployed state in which the filament automatically forms a helical winding in a first direction as viewed from the first device end to the second device end, the helical winding optionally including at least one of a support portion and a filter portion; and deploying the EPD in each carotid artery such that the first end is oriented cephalad to the subject; Including, the distal end of the needle includes an opening and a bevel along a bevel plane; the bevel plane is aligned such that it faces both the midline and the caudal direction of the subject during implantation; a first direction of the filament corresponding to a clockwise direction in response to the device being deployed in the right carotid artery; The EPD implantation method, wherein the first direction of the filament corresponds to a counterclockwise direction in response to the device being deployed within the left carotid artery. (Item 30) 16. A method for embolic protection comprising implanting in a patient's blood vessel an embolic protection device according to any of items 1-15. (Item 31) A method, system, or device according to any of the disclosed embodiments. [Brief explanation of the drawings]

[0015] [Figure 1A] FIG. 1A illustrates a deployed state of an embolic protection device having first and second support portions with an interposed filter portion therebetween, in which a filament is wound in a counterclockwise direction, according to some embodiments of the present disclosure.

[0016] [Figure 1B] FIG. 1B illustrates a deployed state of an embolic protection device having first and second support portions with an interposed filter portion therebetween, in which the filament is wound in a clockwise direction, according to some embodiments of the present disclosure.

[0017] [Figure 2] FIG. 2 is a schematic illustration, from above, of the head and neck of a human patient lying supine and the orientation / position, according to some embodiments, relative to the bevel of a needle or cannula for implanting an embolic protection device within a body vessel.

[0018] [Figure 3] FIG. 3 is a schematic representation of a system (which may be automated) configured for implanting an embolic protection device, according to some embodiments of the present disclosure. DETAILED DESCRIPTION OF THE INVENTION

[0019] DETAILED DESCRIPTION OF SEVERAL EMBODIMENTS Embodiments of the present disclosure are related to those disclosed in PCT Publication No. WO2018 / 073830, having an international filing date of October 20, 2017, PCT Publication No. WO2013 / 179137, having an international filing date of May 30, 2013, and PCT Publication No. WO / 2014 / 111911, having an international filing date of November 27, 2013, each of which is incorporated by reference herein in its entirety. These aforementioned publications are referred to herein as "prior publications."

[0020] 1A-1B illustrate a deployed state of an embolic protection device (which may be referred to as EPDs or an EPD) according to some embodiments of the present disclosure. As shown in FIG. 1A, EPD 200 includes a filament 210 including first and second support portions 201 and 202 and a filtering portion 203 interposed between first and second support portions 201 and 202. EPD 200 may also include, in some embodiments, at least one of, and in some embodiments, multiple of, and in some embodiments, all of, pull wire 204, handle 205, tether 206, and stopper 207. When viewed from end 208 (which may be referred to as the rear or rear end of EPD 200) to end 209 (which may be referred to as the front or front end of EPD 200), and also when viewed from front end 209 to rear end 208, filament 210 is wound in a counterclockwise direction.

[0021] In some embodiments, EPD 200 may include an undeployed, generally linear state (including, according to some embodiments, a generally straight filament) configured to fit within the lumen of a cannula, catheter, or needle (which may be collectively referred to herein as a "needle"; see, e.g., reference numeral 831 in FIG. 3 ). The filament, stalk, first support portion, filtering portion, tether, stopper, pull wire (and in some embodiments, the undeployed state) may be similar to those described in prior disclosures. Furthermore, EPD 200 may be implanted within a blood vessel, such as an artery or vein, using any of the embolic protection implantation systems and / or deployment / implantation methods described in prior disclosures.

[0022] In some embodiments, the diameter of the second support portion is 0.1-2 mm smaller than the diameter of the first support portion, which has been found to improve implantation success rates compared to devices in which both support portions are the same diameter. Furthermore, in some embodiments, the second support portion may or may not be larger (depending on the embodiment) compared to the diameter of the vessel into which the EPD is implanted. In some embodiments, having the first support portion 0.2-0.7 mm larger than the diameter of the carotid artery while having the second support portion 0.5 mm smaller than the first support portion allows for both high implantation success rates and good post-implant device stability.

[0023] The second support portion may otherwise be substantially similar to the first support portion (according to some embodiments).

[0024] 1B, an EPD 220 according to some embodiments of the present disclosure is illustrated. In some embodiments, EPD 220 is substantially similar to EPD 200, except that EPD 220 is wound in a clockwise direction rather than a counterclockwise direction when viewed either from end 208 to end 209 or from end 209 to end 208.

[0025] In some embodiments, upon deployment of an EPD (according to some embodiments) within the carotid artery (e.g., to provide protection against stroke), it may be advantageous to deploy the EPD in a caudal (i.e., head-to-foot) direction (with the "rear" end 208 pointing toward the head and the "front" end 209 pointing toward the feet). In such deployment, and in some embodiments, it is advantageous to: - Deploying a deployed EPD with a counterclockwise wound filament, such as the EPD200, into the left carotid artery; and / or - Deploy an EPD, such as EPD220, in a deployed state with a clockwise wound filament, into the right carotid artery.

[0026] Working Example: 46 units of EPD220 (wound clockwise) and 127 units of EPD200 (wound counterclockwise) were deployed caudally under ultrasound guidance into the right carotid artery of sheep. The implantation success rate was 96% (44 / 46) for EPD220 and 73% (93 / 127) for EPD200. Eighty-three units of the EPD200 were deployed caudally into the left carotid artery of sheep under ultrasound guidance. The implantation success rate was 100% (83 / 83).

[0027] These data sets, according to one embodiment, demonstrate that caudal deployment of EPD 200 (wound in a counterclockwise direction) in the left carotid artery and EPD 220 (wound in a clockwise direction) in the right carotid artery optimizes implantation success in the caudal direction. This is a counterintuitive finding because the right and left carotid arteries are similar tubular structures, and therefore, at first glance, it should not matter whether the EPD is wound in a counterclockwise or clockwise direction. However, the symmetry between right and left is broken due to the presence of anatomical structures, such as the trachea, which can affect the compliance of the right and left arterial walls differently.

[0028] In some embodiments, when deploying an EPD (according to some embodiments) within the carotid artery (e.g., to provide protection against stroke), it is advantageous to deploy the implant in a cephalad (feet-to-head) direction (with the "rear" end 208 pointing toward the feet and the "front" end 209 pointing toward the head). Thus, in such embodiments, it is advantageous to: - Deploying an EPD, such as an EPD200, in a deployed state with a counterclockwise wound filament into the right carotid artery; and / or - Deploy an EPD, such as device 220, in a deployed state in which the filament is wound clockwise, into the left carotid artery.

[0029] 2 illustrates a top view of a human patient lying supine and the orientation / positioning, according to some embodiments, of the bevel of a needle or cannula (see, e.g., reference numeral 831 in FIG. 3 ) used in the methods and systems disclosed herein for implanting an embolic protection device into a body vessel. Thus, needle / cannula 300 is shown (the top view shows a cross section of the needle) including bevel 301, with dotted lines indicating lines connecting the midpoints of the bevel walls on two sides of the bevel and an arrow indicating the direction in which the opening of the needle bevel is pointing, which may be included in any of the embolic protection implantation systems and associated embolic protection device implantation methods described in the prior disclosures.

[0030] When an EPD (according to some embodiments) is deployed within the carotid artery (e.g., to provide protection against stroke), in some embodiments, it is advantageous to deploy the EPD caudally within the left carotid artery, having a deployed state in which the filament is wound counterclockwise, such as EPD 200. In such cases / embodiments, the orientation 302 of the bevel 301 is approximately halfway between the midline direction 303 and the caudal direction 304.

[0031] When an EPD (according to some embodiments) is deployed within the carotid artery (e.g., to provide protection against stroke), in some embodiments, it is advantageous to deploy the EPD caudally within the right carotid artery, having a deployed state in which the filament is wound clockwise, such as EPD 220. In such a case, orientation 305 of bevel 301 may be approximately halfway between midline direction 306 and caudal direction 304.

[0032] When an EPD (according to some embodiments) is deployed within the carotid artery (e.g., to provide protection against stroke), in some embodiments, it is advantageous to deploy the EPD cephalad into the right carotid artery, having a deployed state in which the filament is wound counterclockwise, such as EPD 200. In such cases / embodiments, the bevel orientation may be approximately halfway between the midline direction 303 and the cephalad direction 307.

[0033] When an EPD (according to some embodiments) is deployed within the carotid artery (e.g., to provide protection against stroke), in some embodiments, it is advantageous to deploy the EPD cranially within the left carotid artery, having a deployed state in which the filament is wound clockwise, such as EPD 220. In this case, the bevel orientation may be approximately halfway between midline 306 and cranial 307.

[0034] In some embodiments where the EPD is deployed caudally, it is advantageous for the bevel orientation of the delivery needle to be caudal, regardless of whether the embolic protection device is wound counterclockwise or clockwise. In some embodiments where the EPD is deployed cranially, it is advantageous for the bevel orientation to be cranial, regardless of whether the embolic protection device is wound counterclockwise or clockwise.

[0035] In some embodiments where the EPD is deployed caudally and the EPD has a counterclockwise winding, it is advantageous for the bevel orientation of the delivery needle to be arranged to be midway between the caudal and midline directions 303 if implantation is to occur in the left artery, and midway between the caudal and lateral directions 308 if implantation is to occur in the right artery.

[0036] In some embodiments, in settings where the implantation is performed in a caudal direction and the EPD has a clockwise winding, it is advantageous for the bevel orientation of the delivery needle to be midway between the caudal and midline directions 306 if the implantation is performed in the right artery, and midway between the caudal and lateral directions 309 if the implantation is performed in the left artery.

[0037] An EPD according to the disclosed embodiments can be implanted (generally) via the system disclosed in FIG. 3 (see, e.g., FIG. 8 and corresponding description, which corresponds to one of the systems disclosed in WO 2014 / 111911, incorporated herein by reference), as mentioned above, a brief description of which follows. System 80 comprises a patient-external unit 81 and a patient-internal unit 82. Patient-external unit 81 may be disposable or reusable. Patient-internal unit 82 may be disposable. Device 80 may be sterilizable using means known in the art. Patient-internal unit 82 may be reversibly connected or disconnected from patient-external unit 81, whenever unit 81 is reusable. Such reversible connection means may include any known reversible connection means, such as, for example, a screw, a magnet, or a snap.

[0038] Patient-external unit 81 may include power supply 810, control unit 811, drive mechanisms 819, 832, and 833, gear ring 815, and bearing 816, all of which may be housed within housing 834. Patient-internal unit 82 may include needle 831 and embolic protection device 20. embolic protection device 20 may reside within the lumen of needle 831 in its undeployed, generally linear state.

[0039] Drive mechanism 833 may be configured to advance or retract needle 831 relative to housing 834. Drive mechanism 832 is configured to rotate needle 831. Drive mechanism 819 can be configured to advance or retract device 20 relative to housing 834. Bearing 816 is configured to allow needle 831 to rotate relative to housing 834. Gear ring 815 may be configured to couple needle 831 to drive mechanisms 832 and 833. Gear ring 815 may be attached to the proximal end of needle 831 around the circumference of needle 831.

[0040] Drive mechanism 833 may include motor 818 and pivot 817. Pivot 817 is configured to transmit the linear (forward / reverse) motion generated by motor 818 to gear wheel 815, thereby advancing or retracting gear wheel 815 (and needle 831, to which gear wheel 815 may be precisely connected) relative to housing 834. Gear wheel 815 may be connected to pivot 817 as follows: gear wheel 815 may include a circular groove (not shown) at its proximal end, and the tip of pivot 817 may be inserted into this groove. The shape of the groove may be made such that its opening to the proximal face of gear wheel 815 may be narrower than its interior. Similarly, pivot 817 may include a valve at its distal tip, the maximum width of which is greater than the size of the groove opening. Thus, whenever the tip of pivot 817 is inserted into the groove, the linear motion of pivot 817 is again translated into linear motion of gear wheel 815 (and needle 831) by the coupling of the pivot and the groove. Gear wheel 815, however, rotates freely without interference from pivot 817 because the tip of pivot 817 slides freely within the channel of the groove.

[0041] Drive mechanism 832 may include motor 812, pivot 813, and gear wheel 814. Pivot 832 is configured to transfer rotational motion generated by motor 812 to gear wheel 814.

[0042] Gear ring 815 and gear wheel 814 may be connected by intermeshing gear teeth. Thus, rotation of gear wheel 814 is translated into rotation of gear ring 815. Gear ring 815 is precisely connected to needle 831, so rotation of gear wheel 814 is translated into rotation of needle 831. Gear wheel 814 may be configured to slide relative to gear ring 815 in a linear (forward / reverse) direction. In this way, the rotational coupling between gear wheel 814 and gear ring 815 is preserved regardless of the linear position of gear ring 815 (and needle 831). Bearing 816 allows needle 831 to rotate freely relative to housing 834.

[0043] The drive mechanism 819 may include a motor 835 and a pusher wire 822. The motor 835 may include a stator 820 and a rotor 821. A proximal portion of the flexible pusher wire 822 may rotate about the rotor 821. A distal end of the pusher wire 822, which may reside within the lumen of the needle 831, may be coupled to the proximal end of the device 20. This coupling may be reversible. For example, disconnection of the coupling may be achieved using mechanical or electrical means as known in the art, such as electrolysis.

[0044] Whenever motor 835 is configured to rotate rotor 821 in a counterclockwise direction, pusher wire 822 is advanced relative to needle 831 and device 20 may be advanced relative to the needle. Whenever motor 835 is made to rotate rotor 821 in a clockwise direction, pusher wire 822 is retracted relative to needle 831. This may or may not retract device 20 relative to the needle, depending on the type of coupling between pusher wire 822 and the proximal portion of device 20.

[0045] Whenever the needle 831 rotates relative to the housing 834, the rotational motion is transmitted to the device 20. The transmission of rotational motion between the needle and the device may be achieved by friction between the inner wall of the needle and the device.

[0046] In operation, power supply 810 provides electrical or mechanical power to control unit 811. Control unit 811 transmits power and / or signals to drive mechanisms 832, 833, and 814 according to a predetermined program stored within (for example) the control unit or by commands from an operator transmitted to the control unit via its human-machine interface. Any combination of linear and / or rotational movement of needle 831 and / or device 20 relative to external housing 834 may be implemented.

[0047] In some embodiments, implantation of the embolic filtering device 20 by the automated system 80 within a body vessel may proceed as follows: First, a physician determines that it is desirable to implant the filtering embolic device 20 within the body vessel. Under the guidance of a suitable imaging modality (not shown), such as ultrasound, high-resolution ultrasound, or CT scanning, or without any imaging guidance at all, the operator uses the sharp tip of the needle 831 to penetrate the skin adjacent to the vessel. The operator then carefully advances the system 80 through the subcutaneous tissue, transversely penetrating the vessel. Once this positioning is achieved, the operator commands the control unit 811 to execute a predetermined program (optionally dependent on input from one or more sensors) that properly exteriorizes the device 20, so that the embolic protection device 20 is properly aligned within the lumen. Once the device 20 is properly exteriorized, the operator removes the system 80 from the patient's body.

[0048] (Other points to note) While various embodiments of the present invention have been described and illustrated herein, those skilled in the art will readily envision various other means and / or structures for performing the functions and / or obtaining the results and / or one or more advantages described herein, and each such variation and / or modification is deemed to be within the scope of the embodiments of the present invention described herein. More generally, those skilled in the art will readily appreciate that all structures, parameters, dimensions, materials, functionality, steps, and configurations described herein are intended to be examples, and that the actual structures, parameters, dimensions, materials, functionality, steps, and configurations will depend on the specific application or applications in which the teachings of the present invention are used. Those skilled in the art will recognize or be able to ascertain, using no more than routine experimentation, many equivalents to the specific embodiments of the present invention (and their enumerated elements) described herein. Accordingly, the foregoing embodiments are presented by way of example only, and it will be understood that, within the scope of the claims supported by this disclosure and their equivalents, embodiments of the present invention may be practiced otherwise than as specifically described and claimed. Inventive embodiments of the present disclosure are also directed to each individual feature, system, article, structure, material, kit, functionality, step, classification, and / or method described herein. In addition, any combination of two or more such features, systems, articles, structures, materials, kits, functionality, steps, classifications, and / or methods is included within the inventive scope of the present disclosure, provided such are not mutually inconsistent. Some embodiments are distinguishable over the prior art by the specific absence of one or more features / elements / functionality. (i.e., a claim directed to such an embodiment may include a negative limitation.)

[0049] Also, as noted, various inventive concepts may be embodied as one or more methods. Thus, the acts performed as part of the method may be ordered in any suitable way, and the acts may be configured to be performed in an order different from that disclosed, which may include performing some acts simultaneously even though shown as sequential acts in the illustrative embodiments.

[0050] All references to publications or other literature, including, but not limited to, patents, patent applications, articles, web pages, books, etc., presented anywhere in this application are incorporated herein by reference in their entirety. Furthermore, all definitions, as defined and used herein, should be understood to supersede dictionary definitions, definitions in documents incorporated by reference, and / or ordinary meanings of the defined terms.

[0051] The indefinite articles "a" and "an," as used herein in the specification and claims, should be understood to mean "at least one," unless expressly stated to the contrary.

[0052] The terms "can" and "may" are used interchangeably within this disclosure to indicate that a referenced element, component, structure, feature, functionality, object, advantage, operation, step, process, apparatus, system, device, result, or classification has the capability of being used, included, or produced, or otherwise represents a suggestion set forth in the description in which the term is used for (or referenced to) a particular embodiment.

[0053] The term "and / or," as used herein in the specification and claims, should be understood to mean "either or both" of the elements so combined, i.e., elements being present in conjunction in some cases and disjointed in other cases. Multiple elements listed with "and / or" should be construed in the same manner, i.e., "one or more" of the elements so combined. Other elements may optionally be present other than those specifically identified by the "and / or" clause, whether or not related to those elements specifically identified. Thus, as a non-limiting example, a reference to "A and / or B," when used in conjunction with open-ended language such as "comprising," can refer in one embodiment to A only (optionally including elements other than B), in another embodiment to B only (optionally including elements other than A), in yet another embodiment to both A and B (optionally including other elements), etc.

[0054] In the specification and claims, when used herein, "or" should be understood to have the same meaning as "and / or" as defined above. For example, when separating elements in a list, "or" or "and / or" should be interpreted as being inclusive, i.e., including at least one of several elements or a list of elements, including more than one, and optionally, further unlisted items. Only terms clearly indicated to the contrary, such as "only one of," or "exactly one of," or, when used in the claims, "consisting of," will refer to the inclusion of exactly one element of several elements or a list of elements. Generally, the term "or," when used herein, should only be interpreted to indicate exclusive alternatives (i.e., "one or the other, but not both") when preceded by terms of exclusivity, such as "either," "one of," "only one of," or "exactly one of." "Consisting essentially of," when used in the claims, shall have its ordinary meaning as used in the field of patent law.

[0055] As used herein in the specification and claims, the phrase "at least one," in reference to a list of one or more elements, should be understood to mean at least one element selected from any one or more of the elements in the list of elements, but not necessarily including at least one of each and every element specifically listed in the list of elements, and not excluding any combination of elements in the list of elements. This definition also allows for elements other than the specifically identified elements to be optionally present in the list of elements to which the phrase "at least one" refers, whether related or unrelated to those specifically identified elements. Thus, as a non-limiting example, "at least one of A and B" (or, equivalently, "at least one of A or B," or, equivalently, "at least one of A and / or B") can refer to, in one embodiment, at least one A (optionally including more than one), where no B is present; in another embodiment, at least one B (optionally including more than one), where no A is present; in yet another embodiment, at least one A, optionally including more than one, and at least one B, optionally including more than one, where B is present (optionally including other elements); etc.

[0056] In the claims and the foregoing specification, all transitional phrases such as "comprising," "including," "carrying," "having," "containing," "involving," "holding," "composed of," and similar words are understood to be open-ended, i.e., to mean "including, but not limited to." Only the transitional phrases "consisting of" and "consisting essentially of" shall be closed or semi-closed transitional phrases, respectively, as set forth in Section 2111.03 of the United States Patent Office Manual of Patent Examining Procedures.

Claims

[Claim 1] The invention described in this specification.

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