Monofilament implants and systems for delivery thereof

Abstract

Systems, devices and methods are presented for embolic protection. In some embodiments, a device for implantation in a patient's vessel containing a fluid flow is provided which comprises proximal and distal ends, an undeployed, substantially linear state, and a deployed, spring-like (helical) state comprising windings. When the device is deployed, the line segment connecting the proximal and distal ends is approximately perpendicular to the majority of the windings and to the fluid flow. In some embodiments, a delivery device for the monofilament device is provided. The delivery device comprises a needle having a lumen, a sharp distal end, and a pusher slidable within the needle. A method for deploying the monofilament device using the delivery device is provided.

We claim: 
     
         1 . A system for providing an implant in a patient's vessel, the system comprising:
 a housing,   a power supply,   a control unit,   a driving mechanism,   an implant comprising an undeployed, substantially linear state and a deployed state,   a needle comprising a hollow lumen, a proximal end, and a distal end, wherein said needle is configured to receive the implant in the undeployed state,   wherein the implant is exteriorized from the needle according to a predetermined program, an instruction from an operator, or both.   
     
     
         2 . The system of  claim 1 , wherein the driving mechanism is configured to rotate, bend, or twist said implant. 
     
     
         3 . The system of  claim 1 , wherein the driving mechanism is configured to advance or retract the implant. 
     
     
         4 . The system of  claim 1 , wherein the driving mechanism is configured to advance or retract the needle. 
     
     
         5 . The system of  claim 1 , wherein the implant is selected from the group consisting of: an embolic protection device, an occlusion device, a patent foramen ovale occlusion device, a left atrial appendage occlusion device, a venous occlusion device, an arterial occlusion device, a drug delivery platform, a radiation delivery platform, a cardiac akinesis treatment device, and a stent. 
     
     
         6 . The system of  claim 1 , wherein the housing is configured in the shape of an ergonomic handle. 
     
     
         7 . The system of  claim 1 , further comprising one or more sensors. 
     
     
         8 . The system of  claim 1 , wherein the housing, the power supply, the control unit, and the driving mechanism reside in a patient-external unit. 
     
     
         9 . The system of  claim 8 , wherein the patient-external unit is disposable. 
     
     
         10 . The system of  claim 8 , wherein the patient-external unit is reusable. 
     
     
         11 . The system of  claim 8 , wherein the needle and the implant comprise an internal unit. 
     
     
         12 . The system of  claim 8 , wherein the external unit and the internal unit is reversibly connected. 
     
     
         13 . The system of  claim 1 , wherein the power supply is electrical and/or mechanical. 
     
     
         14 . The system of  claim 1 , wherein the power supply is a direct current source or an alternating current source. 
     
     
         15 . The system of  claim 1 , wherein the control unit comprises one or more of: a man machine interface, an input/output device, an analog or digital electronic controller, and a computer processor. 
     
     
         16 . The system of  claim 1 , wherein the driving mechanism comprises a motor. 
     
     
         17 . The system of  claim 16 , wherein said motor is of one or more of the following types: direct current, universal, alternating current. stepper, permanent magnet, brushed direct current, brushless direct current, switched reluctance, coreless direct current, printed armature, pancake, alternating current with sliding rotor, synchronous electric, induction, doubly fed electric, and torque. 
     
     
         18 . The system of  claim 1 , wherein the needle has an outer diameter less than about 1 mm. 
     
     
         19 . The system of  claim 7 , wherein the at least one sensor is physical, chemical, physiological, or electrophysiological. 
     
     
         20 . The system of  claim 7 , wherein the at least one sensor is mounted on the needle. 
     
     
         21 . The system of  claim 7 , wherein the at least one sensor comprises a pressure sensor. 
     
     
         22 . A method for providing an implant in a patient's vessel, the method comprising:
 providing the system of  claim 1 ,   making a puncture in a wall of the vessel using the sharp distal end of the needle or the distal end of the implant, and   exteriorizing the implant through said puncture by means of signals provided to the driving mechanism by the control unit.   
     
     
         23 . A system for providing an implant in a patient's vessel, the system comprising:
 an implant comprising an undeployed, substantially linear state and a deployed state,   a needle comprising a hollow lumen, a proximal end, and a distal end, wherein said needle is configured to receive the implant in the undeployed state, and   a driving mechanism configured to rotate, bend, or twist said implant, or rotate the needle.   
     
     
         24 . A device for medical use in a patient's vessel containing a fluid flow, the device comprising
 proximal and distal ends,   a substantially linear undeployed state, and   a deployed state having an axis of symmetry,   wherein in the deployed state, the axis of symmetry is approximately perpendicular to the fluid flow.   
     
     
         25 . The device of  claim 24 , wherein the medical use is embolic protection. 
     
     
         26 . The device of  claim 24 , further comprising a filament. 
     
     
         27 . The device of  claim 26 , wherein the filament is configured with a helical shape comprising windings or turns in the deployed state. 
     
     
         28 . The device of  claim 26 , wherein the filament is configured with a circular cross section. 
     
     
         29 . The device of  claim 26 , wherein the length of the filament is between about 7 and about 300 mm. 
     
     
         30 . The device of  claim 26 , wherein the diameter of the filament is less than about 0.2 mm. 
     
     
         31 . The device of  claim 26 , wherein the diameter of the filament is less than about 0.15 mm. 
     
     
         32 . The device of  claim 26 , wherein the undeployed state is configured to fit within the lumen of a tube or a needle, wherein said lumen has a diameter in the range of about 0.05 mm and about 1.0 mm and a length in the range of about 10 mm and about 400 mm. 
     
     
         33 . The device of  claim 24 , wherein the undeployed state is configured in the shape of a helix wherein the pitch is much larger than the diameter. 
     
     
         34 . The device of  claim 27 , wherein the plurality of the windings vary in diameter. 
     
     
         35 . The device of  claim 27 , wherein the plurality of windings approximately trace the shape of a spherical shell. 
     
     
         36 . The device of  claim 27 , wherein the length of a line segment connecting the proximal and the distal ends in the deployed state is larger than the diameter of the vessel. 
     
     
         37 . The device of  claim 36 , wherein the length is in the range of about 7 mm and about 20 mm. 
     
     
         38 . The device of  claim 35 , wherein the diameter of said spherical shell is less than or equal to the diameter of the vessel. 
     
     
         39 . The device of  claim 26 , wherein the proximal most and distal most segments of said filament in the deployed state are substantially collinear with the line segment connecting the proximal and distal ends. 
     
     
         40 . The device of  claim 27 , further comprising a most proximal turn and a most distal turn, wherein each of said turns resides in a potentially different plane roughly parallel to the line segment connecting the proximal and the distal ends. 
     
     
         41 . The device of  claim 40 , wherein the radius of curvature at any point along the filament exceeds a critical value equal to the diameter of the filament divided by twice the critical strain of the material from which the filament is made. 
     
     
         42 . The device of  claim 41 , wherein said critical value is greater than about 0.6 mm. 
     
     
         43 . The device of  claim 27 , wherein the distance between consecutive windings exceeds about 0.7 mm. 
     
     
         44 . The device of  claim 27 , wherein the distance between consecutive windings is less than about 1.5 mm. 
     
     
         45 . The device of  claim 26 , wherein the filament includes a hollow lumen. 
     
     
         46 . The device of  claim 24 , further comprising a radiopaque marker. 
     
     
         47 . The device of  claim 24 , further comprising an echogenic marker. 
     
     
         48 . The device of  claim 26 , wherein the filament is made from a shape memory alloy or a super-elastic alloy. 
     
     
         49 . The device of  claim 26 , further comprising one or two end pieces. 
     
     
         50 . The device of  claim 26 , wherein the proximal most segment of said filament in the deployed state is substantially collinear with the line segment connecting the proximal and distal ends. 
     
     
         51 . The device of  claim 27 , further comprising a most proximal turn, wherein said turn resides in a plane roughly parallel to the line segment connecting the proximal and the distal ends. 
     
     
         52 . The device of  claim 40 , wherein the radius of curvature at any point along the filament exceeds a critical value equal to the diameter of the filament divided by twice the critical strain of the material from which the filament is made. 
     
     
         53 . The device of  claim 52 , wherein said critical value is greater than about 0.6 mm. 
     
     
         54 . A delivery device for the device of  claim 24 , wherein the delivery device comprises:
 a needle having a lumen, a sharp distal end, an outer diameter less than 1 mm, and   a pusher slidable within said needle.   
     
     
         55 . The delivery device of  claim 54 , further comprising a needle handle. 
     
     
         56 . The delivery device of  claim 54 , further comprising a pusher handle. 
     
     
         57 . An end piece for a device comprising a monofilament for implantation in a patient's vessel, the end piece comprising one or more of: a radiopaque marker, an echogenic marker, an anchor, a non-traumatic tip, and a bearing. 
     
     
         58 . The end piece of  claim 57 , wherein the monofilament device is selected from the group consisting of: an embolic protection device, an occlusion device, a patent foramen ovale occlusion device, a left atrial appendage occlusion device, a venous occlusion device, an arterial occlusion device, a drug delivery platform, a radiation delivery platform, a cardiac akinesis treatment device, and a stent. 
     
     
         59 . The end piece of  claim 57 , wherein the end piece is configured with an undeployed and a deployed state. 
     
     
         60 . The end piece of  claim 57 , wherein said anchor comprises one or more of: a roughened surface. a barb, a micro-barb, a hook, a bulge, and a material configured to enlarge upon contact with an aqueous environment. 
     
     
         61 . The end piece of  claim 57 , wherein said radiopaque marker comprises gold, platinum, or any other heavy metal. 
     
     
         62 . The end piece of  claim 57 , wherein said echogenic marker comprises one or more of: a micro-bubble, a micro-bubble coating, and a cornerstone reflector. 
     
     
         63 . The end piece of  claim 57 , wherein said bearing comprises housing and an axle. 
     
     
         64 . The end piece of  claim 63 , wherein said axle is configured to rotate in said housing with any degree of friction. 
     
     
         65 . The end piece of  claim 63 , wherein the axle is integral with the monofilament. 
     
     
         66 . The end piece of  claim 57 , wherein each of the radiopaque marker, the echogenic marker, the anchor, the non-traumatic tip, and the bearing need not be physically distinct. 
     
     
         67 . The end piece of  claim 57 , wherein said bearing is configured to release accumulated torsion or to prevent the build-up of torsion in the monofilament. 
     
     
         68 . A method for implanting a medical device in a patient's vessel containing fluid flow, the method comprising:
 providing a needle having a lumen and a sharp distal end,   providing a pusher slidable within the lumen of the needle,   providing a device having a distal end, an undeployed, substantially linear state, and a deployed state having an axis of symmetry,   loading the device in the undeployed state into the needle,   making a puncture in a wall of the vessel using the sharp distal end of the needle or the distal end of the device, and   exteriorizing the device through said puncture by advancing the pusher, retracting the needle, or both, such that said axis of symmetry is approximately perpendicular to the fluid flow.   
     
     
         69 . The method of  claim 68 , further comprising the step of retracting the needle and the pusher from the patient, and/or making a second puncture at a location approximately diametrically opposed said first puncture. 
     
     
         70 . The method of  claim 68 , wherein the device is anchored proximate said puncture following exteriorization. 
     
     
         71 . The method of  claim 69 , wherein the device is anchored at locations proximate said puncture and said second puncture following exteriorization. 
     
     
         72 . The method of  claims 68 - 71 , wherein said device is selected from the group consisting of: an embolic protection device, an occlusion device, a patent foramen ovale occlusion device, a left atrial appendage occlusion device, a venous occlusion device, an arterial occlusion device, a drug delivery platform, a radiation delivery platform, a cardiac akinesis treatment device, and a stent. 
     
     
         73 . The device of  claim 27 , wherein the length of a line segment connecting the proximal and the distal ends in the deployed state is larger than or equal to the diameter of the vessel. 
     
     
         74 . The device of  claim 36  or  73 , wherein the diameter of every turn or winding is less than or equal to the diameter of the vessel.