Systems, methods and devices for embolic protection

Abstract

Embodiments of the present disclosure are directed to systems, methods and device for providing embolic protection in a patient, and implantation of devices (and systems thereof) for enabling such functionality. In some embodiments, a device is configured for implantation in a body vessel including fluid flow. The device may assume, or be constrained to assume, an un-deployed state and a deployed state. In the un-deployed state, the device or a portion thereof is configured to reside in the lumen of a thin needle or cannula having a diameter of less than about 0.5 mm (for example). The needle may include a curved portion, fix the deployed state, the device has an axis which, when implanted, is positioned approximately parallel to the fluid flow of the vessel. In some embodiments, the device comprises a thin filament body whereby in a deployed state, at least a portion of the filament takes on a helical shape. In some embodiments, at least one helix coil has height or pitch greater than the coil diameter. In some embodiments, the device has a monofilament fitter portion including at least one coil whose center is off the helix axis. The device may be made of a super-elastic alloy so that the device can transition between the un-deployed and the deployed states without plastic deformation (in at least some embodiments). In some embodiments, the device is configured for transcatheter delivery.

What is currently claimed is: 
     
         1 . An embolic protection device (EPD) configured for arrangement within a blood vessel, the EPD comprising:
 a filament configured to include:
 an un-deployed state including a portion configured to fit within a lumen of a needle or a tube; and 
 a deployed state wherein the filament automatically forms a helix comprising a support portion and a filter portion, 
   wherein:
 the support portion comprises a first portion of the helix which includes an axis, comprising an elongated coil having a height which exceeds a diameter thereof; and 
 the filter portion includes a funnel configured to taper in a first direction, the funnel also including at least one reducing coil having a center which is off the axis. 
   and wherein:
 the support portion is configured to at least one of orientate the filler portion within a blood vessel and secure the EPD relative to the blood vessel; 
 at least a portion of the elongated coil is configured to resist axial compression of the support portion; and 
 the reducing coil is configured to capture emboli greater than a predetermined size. 
   
     
     
         2 . The EPD of  claim 1 , wherein the deployed shape further comprises a stem configured to traverse the vessel wall. 
     
     
         3 . The EPD of  claim 1 , further comprising a pull wire configured traverse a patient's skin and enable retraction of the device by pulling the device out of the vessel. 
     
     
         4 . The EPD of  claim 1 , further comprising a stopper configured to prevent the filament from moving from the vessel lumen outwards through a puncture in the vessel. 
     
     
         5 . The EPD of  claim 1 , further comprising an anchor configured to engage tissue externally to the vessel lumen. 
     
     
         6 . The EPD of  claim 1 , further comprising a second support portion wherein the filler portion is interposed between the support portion and the second support portion. 
     
     
         7 . The EPD of  claim 1 , further comprising a second reducing coil whose carter is off the axis. 
     
     
         8 . The EPD of  claim 7 , wherein a line segment connecting the centers of the reducing coil and the second reducing coil intersects the axis. 
     
     
         9 . The EPD of  claim 1 , wherein the filament is made from nitinol. 
     
     
         10 . The EPD of  claim 1 , wherein the filament cross section is round, and the diameter of the cross section is in the range of 0.05 and 0.3 mm. 
     
     
         11 . A system for providing embolic protection in a patient, the system comprising:
 an embolic protection device (EPD);   a needle;   a pusher;   a driving mechanism;   a control unit;   a power supply; and   an input/output device,   wherein:
 a proximal end of the EPD is initially arranged within the lumen of the needle; 
 a distal end of the pusher is initially arranged within the lumen of the needle and proximally to the proximal end of the EPD; and 
 upon an operator instruction through the input/output EPD, the controller causes the pusher to push at least a portion of the EPD out of the needle lumen by means of the power supply and the driving mechanism. 
   
     
     
         12 . The system of  claim 11 , wherein the EPD comprises the EPD of  claim 1 . 
     
     
         13 . The system of  claim 11 , wherein the EPD comprises the EPD of any of  claims 1 - 10 . 
     
     
         14 . A system for providing embolic protection in a patient, the system comprising:
 an embolic protection device (EPD);   a needle;   a pusher having a hollow lumen;   a driving mechanism:   a control unit;   a power supply; and   an input/output device,   wherein:
 a proximal end of a filament of the EPD is initially arranged within the lumen of the needle; 
 the distal end of the pusher is initially arranged within the lumen of the needle and proximally to the proximal end of the EPD; 
 at least a portion of a pull wire of the EPD is arranged within the lumen of the 
 pusher; and 
 upon an operator instruction through the input/output EPD, the controller causes the pusher to push at least a portion of the EPD out of the needle lumen by means of the power supply and the driving mechanism. 
   
     
     
         15 . The system of  claim 14 , wherein the EPD comprises the dev ice of  claim 1 . 
     
     
         16 . The system of  claim 14 , wherein the EPD comprises the device of any of  claims 1 - 10 . 
     
     
         17 . An embolus capturing method comprising:
 puncturing a wall of a blood vessel transcutaneously with an end of a needle, the needle including a lumen housing at least a portion of an embolic protection device (EPD), wherein:
 the EPD comprises a filament configured to include an un-deployed state having a portion configured to fit within a lumen of a needle or a tube, and a deployed state whereby the filament automatically forms a helix comprising a support portion and a filter portion, 
 the support portion comprises a first portion of the helix which includes an axis, comprising an elongated coil having a height which exceeds a diameter thereof; and 
 the filter portion includes a funnel configured to taper in a first direction, the funnel also including at least one reducing coil having a center which is off the axis, 
   directing the distal lip through the skin and into a blood vessel;   deploying the filament from the needle, wherein:
 the filament forms the deployed state, 
 the axis aligns at least approximately with the direction of the flow of blood in the vessel; 
   and   removing the distal tip from the blood vessel and skin.   
     
     
         18 . The method of  claim 17 , wherein the EPD further includes a stem, and wherein the method further comprises arranging the stem to lie within or traverse the vessel wall. 
     
     
         19 . The method of  claim 17 , further comprising arranging at least one of an anchor, a pull wire, and a stopper with the filament during or after deployment. 
     
     
         20 . An embolic protection system for providing embolic protection in a patient, the system comprising:
 a needle:   an EPD including a monofilament, the EPD having an un-deployed shape wherein a portion of the monofilament is configured to fit within the lumen of the needle, and a deployed shape wherein the monofilament has at least one curve;   a pusher,   a driving mechanism;   a control unit;   a power supply; and   an input/output device,   wherein:
 the proximal end of the EPD is initially arranged within the lumen of the needle; 
 the distal end of the pusher is initially arranged within the lumen of the needle and proximally to the proximal end of the EPD; 
 upon an operator instruction through the input/output device the controller causes the pusher to push at least a portion of the EPD out of five needle lumen by means of the power supply and the driving mechanism, and 
 the speed with which the EPD is pushed out of the needle is less than about 2 cm/sec. 
   
     
     
         21 . The system of  claim 20 , wherein the needle comprises a portion that is curved. 
     
     
         22 . An embolic protection device (EPD) configured for arrangement within a blood vessel, the EPD comprising:
 a filament configured to include:
 an un-deployed state comprising a portion configured to fit within a lumen of a needle or a tube; and 
 a deployed state comprising a support portion and a filter portion, 
   wherein
 the support portion is shaped as a helix having an axis, 
 the helix including at least a portion of a coil of the helix whose height exceeds its diameter, 
 at least one coil of the helix includes a diameter which exceeds the diameter of the vessel for which the EPD is placed, 
 the filter portion comprises a plurality of coils whose diameters decrease in the direction towards the proximal or the distal end of the EPD, 
 a reducing element comprising at least one reducing coil of the helix whose center is off the helix axis, and 
 the diameters of the plurality of tapering coils and the at least one reducing coil are smaller than the diameter of the artery. 
   
     
     
         23 . An embolic protection implantation system for implanting an embolic protection device (EPD) within a vessel of the body comprising:
 a housing;   a needle having a lumen, wherein the needle is configured to at least one of house, at least partially, and guide an EPD into a vessel of the body of a patient:   a pusher configured to push or otherwise move at least the EPD relative to the needle; and   a driving mechanism configured to move at least one of the pusher and the EPD so as to deploy the EPD into the vessel.   
     
     
         24 . The system of  claim 23 , further comprising an EPD configured to assume an un-deployed shape including a curved portion. 
     
     
         25 . The system of  claim 23 , wherein the driving mechanism comprises at least one of a motor, a pinion, a spur, and a planetary gear. 
     
     
         26 . The system of  claim 23 , wherein the needle is connected to the housing. 
     
     
         27 . The system of  claim 23 , wherein the needle includes a straight portion and a curved portion. 
     
     
         28 . The system of  claim 27 , wherein at least part of the straight portion is arranged externally to the housing, and/or at least part of the curved portion is arranged within the housing. 
     
     
         29 . The system of  claim 27 , wherein the curved portion includes one or more coils or turns. 
     
     
         30 . The system of  claim 23 , further comprising a drum. 
     
     
         31 . The system of  claim 30 , further comprising an axle configured to enable the drum to rotate thereon. 
     
     
         32 . The system of  claim 31 , wherein the axle is connected to the housing. 
     
     
         33 . The system of  claim 25 , further comprising a drum, wherein the spur is connected to the drum. 
     
     
         34 . The system of  claim 23 , wherein the in-deployed state of the EPD is inherited from the configuration of the needle. 
     
     
         35 . The system of  claim 23 , wherein the EPD is at least partially housed within the lumen of the needle. 
     
     
         36 . The system of  claim 23 , further comprising at least one of: a power supply, a controller, and an input and/or output device. 
     
     
         37 . The system of  claim 23 , wherein at least part of the pusher is housed within the lumen of the needle. 
     
     
         38 . The system of  claim 23 , wherein the pusher is configured to initially reside external to the lumen of the needle. 
     
     
         39 . The system of  claim 23 , wherein a distil end of the pusher is arranged proximally to a proximal end of the EPD. 
     
     
         40 . The system of  claim 30 , wherein a proximal end of the pusher is connected to the drum. 
     
     
         41 . The system of  claim 23 , wherein the pusher is configured to extend towards a proximal end of the needle through guides or channels. 
     
     
         42 . The system of  claim 23 , wherein the pusher includes a lumen or is solid. 
     
     
         43 . The system of  claim 42 , wherein the pusher includes a lumen, and a pull wire of the EPD is arranged within the lumen of the pusher. 
     
     
         44 . The system of  claim 42 , wherein a proximal end of the pull wire protrudes proximally from a proximal end of the pusher. 
     
     
         45 . The system of  claim 23 , wherein rotation of the driving mechanism in a first direction effects rotation of the drum in a second direction. 
     
     
         46 . The system of  claim 36 , wherein the input output device comprises at least a button for operating the system. 
     
     
         47 . The system of  claim 23 , comprising a first part configured lo be disposable and a second part configured to be reusable. 
     
     
         48 . The system of  claim 48 , wherein the reusable part includes one or more of the housing, an input-output device, a controller, a power supply, and all or portions of the driving mechanism. 
     
     
         49 . The system of  claim 48 , wherein the disposable part includes one or more of the needle, the embolic protection device, and at least a portion of the driving mechanism. 
     
     
         50 . The system of  claim 48 , wherein the reusable and disposable pans are reversibly connected with each other. 
     
     
         51 . The system of  claim 23 , further comprising at least one of an LED or audio output device, wherein one and/or another is configured to indicate that the EPD is fully exteriorized from the needle. 
     
     
         52 . The system of  claim 23 , wherein fully exteriorized docs not include exteriorization of one or more of a stem, an anchor, and a pull wire of the EPD. 
     
     
         53 . The system of  claim 23 , wherein at least a portion of the needle comprises a flexible tube. 
     
     
         54 . The system of  claim 53 , wherein the flexible tube comprises at least one of nitinol and polymer, and wherein the distal portion of the needle comprises the flexible tube, such that the tip of the needle is flexible. 
     
     
         55 . The system of  claim 53 , further comprising a catheter configured to provide transcutaneous access to the lumen of a blood vessel proximate an entry site on the skin of a patient. 
     
     
         56  The system of  claim 53 , wherein the flexible tube is configured with a curved portion and a distal end configured to puncture the wall of the vessel such that the distal end can optionally pierce the vessel from inside to outside. 
     
     
         57 . An embolic protection device (EPD) implanting system for implanting an embolic protection device (EPD) within a vessel of the body comprising:
 a housing;   a flexible tube having a lumen, wherein the flexible tube is configured to at least one of house, at least partially, and guide an EPD into a vessel of the body of a patient;   a pusher configured to push or otherwise move at least the EPD relative to the flexible tube,   a drum; and   a driving mechanism configured to move at least one of the pusher, the drum, the flexible tube and the EPD so as deploy the EPD into the vessel.   
     
     
         58 . An embolic protection device (EPD) implanting method for implanting an embolic protection device (EPD) into a vessel comprising:
 providing an EPD implanting system, wherein at least a portion of a needle configured to aid in the implantation of an EPD comprises a flexible tube;   providing a catheter;   piercing the skin of a patient at an entry site, the entry site being proximate a blood vessel of a patient;   arranging the catheter relative to the patient such that a distal end thereof is placed adjacent an implantation site within the lumen of the blood vessel and a proximal end thereof protruding outside the skin at the entry site;   guiding the flexible tube into the lumen of the catheter through the proximal end thereof until a distal end of the flexible tube is arranged at or near the implantation site within the blood vessel;   deploying the EPD at or near the implantation site;   withdrawing the flexible tube and leaving the EPD at the implantation site; and   withdrawing the catheter.   
     
     
         59 . The method of  claim 58 , wherein the EPD implanting system comprises the system according to  claim 57 . 
     
     
         60 . The method of  claim 58 , wherein the EPD implanting system comprises the system according to any of  claims 20 ,  21  and  23 - 57 . 
     
     
         61 . A embolic protection device (EPD) implanting method for implanting an embolic protection device (EPD) comprising:
 providing an EPD implanting system;   providing a catheter;   piercing the skin of a patient at an entry site, the entry site being proximate a blood vessel of a patient;   arranging the catheter relative to the patient such that a distal end thereof is placed adjacent an implantation site within the lumen of the blood vessel and a proximal end thereof protruding outside the skin at the entry site;   guiding the flexible tube into the lumen of the catheter through the proximal end thereof until a distal end of the flexible tube is arranged at or near the implantation site within the blood vessel;   deploying the EPD at or near the implantation site;   withdrawing the flexible tube and leaving the EPD at the implantation site; and   withdrawing the catheter.   
     
     
         62 . The method of  claim 61 , wherein the EPD implanting system comprises the system according to  claim 57 . 
     
     
         63 . The method of  claim 61 , wherein the EPD implanting system comprises the system according to any of  claims 20 ,  21  and  23 - 57 .