US20110319905A1 - Multiple function vascular device - Google Patents

Abstract

A multi-purpose vascular device defines a lumen allowing fluid communication there through and has a coil with a side of the coil winds having solid physical connections between the coil winds to prevent the connected coil wind side from expanding following the application of force by an actuating member which causes the connected coil winds to have a predetermined configuration in an unstressed state. The application of longitudinal force causes the unconnected coil winds to expand, resulting in the vascular device assuming a different configuration.

Description

FIELD OF THE INVENTION
• The present invention relates to apparatus and methods for performing surgical procedures that access hollow conduits of mammalian anatomy. More particularly, the invention discloses a multi-function device for navigating tortuous vascular pathways, reaching and then crossing total occlusions in blood vessels.
BACKGROUND
• Intracorporal medical devices have been developed and used to navigate and access the tortuous vascular and other hollow conduits of a mammalian body. Some of these devices include guidewires, catheters, intravenous guidewires, stylets, intravenous catheters and related devices like endoscopes and colonoscopes that have a predetermined degree of flexibility and may have straight or pre-formed, shaped ends to guide the device through the anatomical conduit. Of the devices that are employed to reach vascular blockages, each has certain advantages and disadvantages. Many fall short of desired performance before reaching a vascular blockage because of a device prolapse at a vascular bifurcation, an inability to enter a bifurcation or be directed to the site of therapy. Others may reach an occlusion but then require a different device to be introduced before crossing the stenosis. The medical industry has striven to reach a balance between the flexibility required to negotiate around tortuous pathways and the rigidity necessary to stabilize a catheter's advancement. Many products such as intravenous interventional guidewires provide directability, flexibility or stiffness but fail to do all or a combination at the same time. These products typically have pre-formed flexible distal ends that provide minimal directability but not true directability, flexibility and stiffness combined, which would be the most useful advantage. Additionally, most physicians must use a series of different diameter guidewires to perform one procedure, creating a procedure that costs additional time, money and risks patient safety from vascular injury.
• Accessing occlusions having relatively sharp angles and passage constrictions using conventional guidewires having pre-formed “J” shapes or angled distal ends requires rotating the guidewire while simultaneously moving it proximally and distally. This action can cause damage to the fragile endothelial cell layer lining blood vessels. Additionally, conventional guidewires can lose their ability to be rotated when the flexible distal ends enter vessels of reduced diameter. Rotation of the guidewire following inserting the distal end into a vessel having a reduced diameter produces high frictional forces between the walls of the small vessels and the guidewire. A desirable device would therefore require reduced rotation and increased ability to advance in a forward or distal direction through tortuous anatomies.
• Another undesirable characteristic of conventional guidewires is the inability to support a catheter at the flexible, tapered, distal end. When a catheter is advanced toward a vascular location in and close to a bifurcation, the catheter tends to proceed in a straight line rather than following the guidewire, defined as prolapse. Further, the natural pulsation of the vascular system of a living animal can cause a conventional guidewire to move into or out of the body during the procedure, thereby losing its distal location.
• An additional disadvantage of a general use catheter is that it must be inserted into the body over a guidewire. Therefore, both a catheter and a guidewire must be used to reach a targeted site within the body. A single device that functions as an independent guidewire or both a catheter and a guidewire would save procedural time, reduce patient recovery time and cause less vascular damage to the patient.
• Still another disadvantage related to current practices resides in the catheter itself. Conventional catheters typically have totally open distal ends. Manufacturers have made efforts to design catheters with soft distal ends to minimize the extent of vascular damage when the open end engages the interior wall of blood vessels. This scraping of the endothelial layer results in a triggering of the auto immune system, causing clots to form at the damage site. Also, the distal end of the catheter may become clogged with material removed from the interior wall of the blood vessels. It is apparent that this bolus of material will be expelled from the distal catheter end when another device is inserted through the catheter. An all-in-one device having a soft, closed distal end that opens to allow other devices to be deployed from the distal end and then re-closing when the devices are withdrawn, would resolve this problem.
• Once the occlusion is reached, the objective is to cross the blockage with the guidewire or remove the guidewire and insert yet another device to cut through the occlusion. This is inherently disadvantageous in that additional time is required and a greater risk of vascular damage or perforation of the vessel wall is presented. Conventional devices used to cross the blockage are generally stiffer than conventional guidewires and when inside the catheter and reaching a bifurcation can cause the more flexible catheter to move away from the target site and follow the guide into the opposite branch of the bifurcation.
• Physicians generally have four objectives when using such vascular devices: (1) To reach the occlusion; (2) To reach the occlusion without causing vascular damage; (3) To cross the occlusion once it is reached; and (4) To reach the occlusion and cross it in as little time as possible. A device able to accomplish all four objectives would be extremely advantageous. It is not uncommon for a physician to place a catheter somewhere in a vessel and exchange the first guidewire with one or more secondary guidewires having progressively stiffer distal ends to prevent prolapse of the devices placed over the guidewire(s). Yet another advantage would be having a guidewire stiff enough to be pushed and yet be directed into branched vessels with minimal torquing. Still another advantage would be a multi-function device able to carry a second device that could bore its way through an occlusion.
• Vascular occlusions defined as Chronic Total Occulsions are blockages that can occur anywhere in a patient's vascular system, including coronary, carotid, renal, iliac, femoral, cerebral, popliteal and other peripheral arteries.
• U.S. Pat. No. 4,676,249 to Arenas discloses a guidewire having a moving internal member to provide stiffness when required, but does not disclose a directable distal end or the ability to cross occlusions. Another U.S. Pat. No. 5,542,434, discloses a longitudinally movable core wire made of a memory metal alloy that stiffens when subjected to thermal energy. This allows the wire to become stiff and yet torquable when desired, but fails when a catheter needs to be slid over the device. Both devices are deficient when they reach an occlusion with heavily calcified plaque in that they do not have the ability to bore through the occlusion.
• Using a conventional guidewire to reach the occlusion requires a catheter to be pushed over the guidewire, the final guidewire removed and then another device to be pushed through the catheter and used to cross the blockage. Such devices are generally known as percutaneous transluminal thrombectomy or artherectomy devices. These devices have various means to cross the occlusion and are singular devices lacking the ability to solely navigate the vasculature. As an example, one such device is disclosed in U.S. Pat. No. 6,945,951 and describes a thrombectomy catheter using high velocity saline through jets that erode away the blockage and cross an occlusion.
• For all these and other reasons there is a clear need for a single device that can vary its distal end, is relatively stiff, has the ability to cross an occlusion and/or a feature that can drill or bore its way through an occlusion.
SUMMARY
• In one aspect, the invention is directed to a vascular device including a shaft defining a longitudinal dimension, a lumen allowing fluid communication through the shaft extending along the longitudinal dimension and a proximal section and a distal section. The distal section further defines a weak side and a strong side and an actuating member is attached to the distal section, with the actuating member being capable of transmitting longitudinal force to the distal section. When longitudinal force is applied to the actuating member, the weak side of the distal section increases in size while the strong side maintains substantially the same size, resulting in the distal section deflecting.
• In another aspect, the invention is directed to a vascular device including a shaft defining a lateral dimension, a longitudinal dimension, a proximal section, a distal section having greater flexibility than the proximal section and a lumen allowing access through the shaft extending along the longitudinal dimension. The shaft at least partly defines a coil, and the coil further defines a distal end. An actuating member is attached to the coil, and is capable of transferring longitudinal force to the coil. A side of the coil winds is physically connected, defining a connected side, which maintains the coil winds on the connected side in a constant configuration preventing differential spacing resulting from the application of longitudinal force and causing the connected coil winds to have a predetermined configuration in an unstressed state. When longitudinal force is applied to the actuating member, an unconnected side of the coil winds expands, resulting in the vascular device assuming a stressed configuration having a different shape than the vascular device in the unstressed configuration.
• In a further aspect the invention is directed to a vascular device, including a shaft defining a lateral dimension, a longitudinal dimension, a proximal section, a distal section having greater flexibility than the proximal section and a lumen allowing access through the shaft extending along the longitudinal dimension. The shaft at least partly defines a coil, with the coil further defining a distal end. A flexible cutting shaft extends through the lumen and defines a proximal end and a distal end, with a cutting burr attached to the distal end of the cutting shaft. An actuating member is attached to the coil and is capable of transferring longitudinal force to the coil. A side of the coil winds is physically connected and defines a connected side, which maintains the coil winds on the connected side in a constant configuration preventing differential spacing resulting from the application of longitudinal force and causing the connected coil winds to have a predetermined configuration in an unstressed state. When longitudinal force is applied to the actuating member an unconnected side of the coil winds expands, resulting in the vascular device assuming a stressed configuration having a different shape than the vascular device in the unstressed configuration.
BRIEF DESCRIPTION OF THE DRAWINGS
• FIG. 1 is a cross sectional centerline view taken along the longitudinal axis of a vascular device of the present invention having a hollow actuating member.
• FIG. 1A is a cross sectional centerline view taken along the longitudinal axis of the vascular device ofFIG. 1, in a deflected configuration, following the application of distal force to the actuating member.
• FIG. 1B is a cross sectional centerline view taken along the longitudinal axis of the vascular device ofFIG. 1, in a deflected configuration, following the application of proximal force to the actuating member.
• FIG. 1C is a lateral cross section view of the guidewire ofFIG. 1 taken through the lines1C-1C, illustrating the locations of the non-expandable side and expandable side.
• FIG. 2 is a cross sectional centerline view taken along the longitudinal axis of a vascular device of the present invention with a hollow conduit extending the length of the device and having a fibrous polymer or metal actuating member.
• FIG. 2A is a cross sectional centerline view of the embodiment of the vascular device ofFIG. 2 in a deflected configuration following the application of proximal force.
• FIG. 2B is a lateral cross section view of the guidewire ofFIG. 2 taken through thelines2B-2B, illustrating the locations of the non-expandable side and expandable side.
• FIG. 3 is a cross sectional centerline view taken along the longitudinal axis of an alternative embodiment of the vascular device having a hollow actuating member, a handle and a cutting burr.
• FIG. 3A is a cross sectional centerline view of the embodiment shown inFIG. 3 in a deflected configuration following the application of distal force.
• FIG. 3B is a cross sectional centerline view of the embodiment shown inFIG. 3 in a deflected configuration following the application of proximal force.
• FIG. 3C is a lateral cross section view of the guidewire ofFIG. 3 taken through thelines3C-3C, illustrating the locations of the non-expandable side and expandable side.
• FIG. 4 is a cross sectional centerline view taken along the longitudinal axis of an alternative embodiment of the vascular device having a hollow actuating member, a handle and a cutting head which are covered by a sheath.
• FIG. 4A is a side plan view of an embodiment of the vascular device shown inFIG. 4.
• FIG. 4B is a cross sectional centerline view of the embodiment shown inFIG. 4 in a deflected configuration following the application of distal force.
• FIG. 4C is a cross sectional centerline view of the embodiment shown inFIG. 4 in a deflected configuration following the application of proximal force.
• FIG. 4D is a lateral cross section view of the guidewire ofFIG. 4 taken through the lines4D-4D, illustrating the locations of the non-expandable side and expandable side.
• FIG. 5A shows the vascular device ofFIG. 3 in use following introduction into a patient, approaching an obstruction at the onset of treatment.
• FIG. 5B shows the vascular device ofFIG. 3 in use during treatment.
• FIG. 5C shows the vascular device ofFIG. 3 in use following completion of treatment.
• FIG. 5D shows the vascular device ofFIG. 3 in use with the vascular device contained in a catheter used to aspirate debris from the treatment site.
• FIG. 5E shows a vascular device similar to that shown inFIG. 4, having an angled cutting shaft, in use during treatment.
DETAILED DESCRIPTION
• Nomenclature
• 50 Catheter
• 400 Vascular Device
• 402 Hollow Shaft
• 402aProximal Termination of Hollow Shaft
• 402bDistal Termination of Hollow Shaft
• 404 Actuating Member
• 406 Coil
• 406aOpen Wound Coil Section
• 406bSolid Coil Section
• 407 Distal Section
• 408 Weld
• 410 Distal Lumen Opening
• 412 Proximal End of Solid Coil Section
• 414 First Lumen
• 416 Second Lumen
• 418 Ribbon
• 420 Cutting Head
• 422 First Handle
• 423 Third Handle
• 424 Cutting Shaft
• 424aProximal End of Cutting Shaft
• 424bDistal End of Cutting Shaft
• 425 Second Handle
• 426 Flattened Section of Coil
• 428 Solder
• 430 Non-Expandable Side
• 432 Expandable Side
• 500 Vascular Device
• 502 Hollow Shaft
• 504 Actuating Member
• 505 Sheath
• 506 Distal End (of Vascular Device)
• 508 Slit
• 510 Coil
• 510aOpen Wound Coil Section
• 510bSolid Coil Section
• 512 Weld
• 514 First Lumen
• 516 Second Lumen
• 517 Distal Section
• 518 Ribbon
• 520 Cutting Head
• 524 Cutting Shaft
• 524aProximal End of Cutting Shaft
• 524bDistal End of Cutting Shaft
• 526 Flattened Section of Coil
• 528 Solder
• 530 Non-Expandable Side
• 532 Expandable Side
• 534 First Handle
• 536 Second Handle
• 600 Vascular Device
• 602 Coating
• 604 Actuating Member
• 606 First Lumen
• 608 Coil
• 610 Second Lumen
• 612 Ribbon
• 614 Open Coil Section
• 615 Flattened Section of Coil
• 616 Distal Closed Coil Section
• 617 Distal Section (of Vascular Device)
• 618 Actuating Member Attachment
• 620 Distal First Lumen Opening
• 622 Non-Expandable Side
• 624 Expandable Side
• 626 Handle
• 628 Proximal Closed Coil Section
• 718 Cutting Shaft
• 720 Cutting Head
• 722 Angle in Cutting Shaft
• 1000 Vascular Vessel
• 1002 Vascular Obstruction
• 1002aAttached Obstruction
• 1002bObstruction Debris
• 1400 Vascular Device
• 1410 Central Space
• 1412 Distal Section
• 1412aLoose Wound Section
• 1412bTight Wound Section
• 1414 Coil
• 1415 Proximal Coil Section
• 1416 Flattened Section of Coil
• 1418 Ribbon
• 1420 Hollow Member
• 1422 Lumen
• 1424 Solder
• 1426 Coating
• 1428 Distal End of Vascular Device
• 1429 Proximal End of Coil
• 1430 Actuating Member
• 1432 Actuating Member Attachment
• 1434 Distal End of Coil
• 1436 Distal Lumen Opening
• 1438 Non-Expandable Side
• 1440 Expandable Side
• 1442 Handle
• Definitions
• “Anatomical Conduit” refers to a naturally occurring vessel or duct within a patient's body.
• “Distal” means further from the point controlled by the operator (e.g., physician or technician) of a device.
• “Distal Force” means force applied in a distal direction or toward a distal end of the device.
• “ePTFE” means expanded polytetrafluoroethylene.
• “FEP” means fluorinated ethylene-propylene.
• “Handle” means a device used to grip certain components of the invention for the purpose of causing longitudinal movement of additional components.
• “Longitudinal Force” means either distal force or proximal force.
• “Prolapse” refers to an adverse event occurring when a medical device does not follow the desired path at a vascular bifurcation but instead where a relatively stiff device forces a relatively less stiff device straight through the vessel, pulling the less stiff device out of the side branch of the bifurcation.
• “Proximal” means closer to the point controlled by the operator (e.g., physician or technician) of a device.
• “Proximal Force” means force applied in a proximal direction or toward a proximal end of the device.
• “PTFE” means polytetrafluoroethylene.
• Construction
• The following detailed description is to be read with reference to the drawings in which similar components in different drawings have the same nomenclature. The drawings, which are not necessarily to scale, show illustrative embodiments and are not intended to limit the scope of the invention.
• It should be noted that combinations of materials and components described within this specification may be interchangeable and anyone skilled in the art will understand that a combination of materials or exchange of other materials to accomplish the work of the invention will not depart from the spirit of the invention. It is further understood that the invention is not limited to vascular use and can also be applied to use through an endoscope, gastroenterological procedures, laparoscope, artherectomy procedures, urological procedures or neurological procedures.
• For the purpose of describing the actuation of the embodiments of theinvention600,1400 as described below, ahandle626,1442 is used. The function of thehandle626,1442 is to contact thecoated coil608,1414, move the actuatingmember604,1430 and provide greater control to the operator. Using thehandle626,1442 allows the application of a longitudinal force (distal or proximal) from a proximal end (unnumbered) of thedevice600,1400 to the attached actuatingmember604 and proximal force to theactuating member1430, which causes a sliding motion. As described in detail below, the application of longitudinal force causes adistal section617,1412 of thevascular device600,1400 to deflect. In the cases of the embodiments of theinvention400,500 afirst handle422,534, contacts thehollow shaft402,502 and is attached to the actuatingmember404,504 allowing longitudinal force to be applied to thedistal section407,517, causing it to deflect. Asecond handle425,536 is attached to a cuttinghead420,520 which distally extends from adistal lumen opening410 or asheath505 and manually rotated in procedures requiring plaque removal.
• FIG. 1 shows a cross sectional centerline view taken along the longitudinal axis of avascular device600 having afirst lumen606 and asecond lumen610. Thevascular device600 can be used as a guidewire or a catheter or as a combination of the two. The presence of afirst lumen606 and asecond lumen610 allows thedevice600 to function as an aspiration device as well as a catheter so that during a medical procedure it can be simultaneously used to deliver other medical devices to a remotely navigated anatomical site and to aspirate fluids. Thedevice600 can also be used for the delivery of therapeutic fluids through thefirst lumen606 to remote anatomical sites following navigation using thedevice600 as a guidewire. Thedevice600 includes acoil608 defining a proximalopen coil section614 and a distalclosed coil section616. A proximalclosed coil section628 extends proximally of adistal coil section617 and is wound in a relatively closed coil configuration similar to the distalclosed coil section616. In one embodiment, thecoil608 can be made from a radiopaque material such as a platinum-nickel alloy that allows the physician to visualize the position of thecoil608 using radiological means, thereby navigating thevascular device600 into desired anatomical pathways with minimal forward motion. In a manner similar to the other embodiments of theinvention400,500 thedevice600 is capable of deflecting by applying longitudinal force to anactuating member604 which causes theexpandable side624 of thecoil608 to expand while thenon-expandable side622 is prevented from expanding by being fixedly attached to aribbon612 as explained below. The actuatingmember604 can be made from a variety of materials having sufficient strength to be able to cause thedistal section617 to deflect and still be flexible enough to move with thecoil608, including but not limited to stainless steel alloys, nickel titanium alloys and reinforced polymeric materials such as Kevlar® or fabric materials. Anouter polymer coating602 covers thedevice600 to the proximal point of attachment (unnumbered) of theribbon612, leaving theopen coil section614 exposed. Theribbon612 is attached to theopen coil section614 at a flattenedsection615. Means of attaching theribbon612 include but are not limited to adhesives, laser welding, or soldering. When negative pressure is applied to thesecond lumen610 thedevice600 can be used as an aspiration device to remove fluid or debris through the spaces between theopen coil section614, from an anatomical location thedevice600 has been navigated to. The distalclosed coil section616 is close or tight wound and forms anarea618 for attaching ahollow actuating member604. The actuatingmember604 can be made from a variety of materials having sufficient strength to be able to cause thedistal section617 to deflect and still be flexible to flex enough to curve with thecoil608, including but not limited to stainless steel alloys, nickel titanium alloys and reinforced polymeric materials such as Kevlar® or fabric materials. Thefirst lumen606 which extends through the center of the actuatingmember604 can also be used for aspirating fluids or debris when negative pressure is applied to thefirst lumen606. Likewise, thefirst lumen606 can be used for delivery of drugs or therapeutic fluids when positive pressure is applied. Acoating602 such as non-thrombogenic polymers, PTFE, ePTFE, FEP, polyester, polyurethane, polyethylene, silicone or hydrophilic may be applied over the proximal section (unnumbered) of thecoil608 to improve sterility as well as enhancing the outer smoothness of theguidewire600, thereby causing less trauma to the patient during introduction, the procedure itself and removal. In one embodiment thecoating602 is applied to thecoil608 by applying a polymer heat shrink tubing such as a PTFE, FEP, or polyester, followed by the application of a proper amount of heat or an appropriate length of time. In additional embodiments thecoating602 is applied by dipping theguidewire600 into a dispersion polymer such as urethane or silicone, by spraying a polymer such as PTFE, FEP, polyester or silicone or by a co-extrusion process of a polymer such as PTFE, FEP, polyester, urethane or silicone. An additional advantage of acoating602 is a reduction in adverse reactions due to adhesion of platelets, proteins, cells or other fouling materials, which can cause fibrin clot production.
• When distal force is applied to the actuatingmember604 by the operator, as shown inFIG. 1A, thedistal section617 deflects due to thenon-expandable side622 to which theribbon612 is attached being prevented from expanding while allowing theexpandable side624 to expand, resulting in thedistal section617 assuming a deflected configuration as best shown inFIG. 1A. As shown inFIG. 1B, if proximal force is applied to the actuatingmember604 thedistal section617 is deflected in another direction than when distal force is applied. This is due to the pitch of the openwound coil section614 having a relatively loose or open pitch to the coil winds (unnumbered), which allows the coil winds (unnumbered) on theexpandable side624, to be forced into a closer configuration. If the actuatingmember604 is coupled with an actuating mechanism (not shown) such as a vernier type mechanism (not shown) a predictable and variable amount of deflection can be achieved with the application of a given amount of longitudinal force.FIG. 1C shows a lateral cross section of thevascular device600 taken through the lines1C-1C and illustrates the locations of thenon-expandable side622 andexpandable side624.
• FIG. 2 is a cross sectional centerline view taken along the longitudinal axis of avascular device1400 of the present invention having afibrous actuating member1430 or metal actuating member (not shown) attached1432 to adistal end1434 of acoil1414 enabling thevascular device1400 to deflect to an alternative shape upon proximal force being applied to theactuating mechanism1430. Thevascular device1400 can be used as a guidewire or a catheter or as a combination of the two. Thedevice1400 includes acoil1414 defining adistal section1412, further defining aloose wound section1412aand atight wound section1412b. Aproximal coil section1415 extends proximally of thedistal coil section1412 and may be wound in a relatively closed coil configuration similar to thetight wound section1412b. In one embodiment, thecoil1414 can be made from a radiopaque material such as a platinum-nickel alloy that allows the physician to visualize the position of thecoil1414 using radiological means, thereby navigating thevascular device1400 into desired anatomical pathways with minimal forward motion. Thecoil1414 extends between adistal end1434 and aproximal end1429 and defines acentral space1410 inside the coil winds. Thecoil1414 defines a flattenedsection1416 towards thedistal end1434 which is configured to receive aribbon1418 which is affixed to thecoil1414. Theribbon1418 is made of a suitable metallic material such as austenitic stainless steel alloy or a tungsten alloy such as tungsten-molybdenum and tungsten-rhenium. In some instances, iridium is added to the alloy to increase strength and radiopaqueness. In another embodiment (not shown) theribbon1418 is not used and instead the deflectabledistal section1412 is defined by a series of welds (not shown), gluing (not shown) or mechanical fasteners (not shown) affixed to the coil winds. In an alternative embodiment (not shown), theribbon1418 is replaced by the application of a polymer fiber fused tocoil1414. The fiber (not shown) is entangled into thecoil1414 by means of weaving in and out of the coil winds and looping around the individual coil winds to form a solid attachment after application of an adhesive. The ribbon1418 (or other means of securing) functions to bind together the portions of thecoil1414 to which it is attached to form anon-expandable side1438 as best shown inFIG. 2B. Means of attaching theribbon1418 to the flattenedsection1416 include but are not limited to adhesives, laser welding, or soldering. Thus, when proximal force is applied to theactuating member1430 by the operator, thedistal section1412 will deflect due to thenon-expandable side1438 of thecoil1414 to which theribbon1418 is attached being prevented from expanding while allowing theexpandable side1440 to expand, resulting in thedistal section1412 deflecting from a straight configuration. If theactuating member1430 is coupled with an actuating mechanism (not shown) such as a vernier type mechanism (not shown) a predictable and variable amount of deflection can be achieved with the application of a given amount of proximal force. It is also observed that along thedistal section1412 thecoil1414 defines aloose wound section1412awhere it is wound at a lesser or looser pitch than the remainder of thecoil1414, imparting a greater degree of flexibility to thedistal section1412. Attached bysolder1424 or other means to thecoil1414 at thedistal end1428 is ahollow member1420 which resides inside thecentral space1410 and extends the length of thevascular device1400. Thehollow member1420 functions to add stiffness and stability to thevascular device1400, while also defining alumen1422 which can be used for such purposes as drug delivery, aspiration or as a general catheter. Thehollow member1420 can be made from a variety of materials having sufficient strength to be able to cause thedistal section1412 to deflect and still be flexible enough to move with thecoil1414, including but not limited to stainless steel alloys, nickel titanium alloys and reinforced polymeric materials such as Kevlar® or fabric materials. Theactuating member1430 can be made of a polymeric material such as Kevlar® or other suitable metallic material such as stainless steel and is attached bysolder1424 or other means to thedistal end1434 of thecoil1414 and routed through thecentral space1410 so as to be able to apply proximal force to thedistal section1412, allowing an operator to precisely deflect thedistal section1412 thereby enhancing the steerability and overall maneuverability of thevascular device1400. Acoating1426 such as non-thrombogenic polymers, PTFE, ePTFE, FEP, polyester, polyurethane, polyethylene, silicone or hydrophilic may be applied over thecoil1414 to improve sterility as well as enhancing the outer smoothness of theguidewire1400, thereby causing less trauma to the patient during introduction, the procedure itself and removal. In one embodiment thecoating1426 is applied to thecoil1414 by applying a polymer heat shrink tubing such as a PTFE, FEP, or polyester, followed by the application of a proper amount of heat or an appropriate length of time. In additional embodiments thecoating1426 is applied by dipping theguidewire1400 into a dispersion polymer such as urethane or silicone, by spraying a polymer such as PTFE, FEP, polyester or silicone or by a co-extrusion process of a polymer such as PTFE, FEP, polyester, urethane or silicone. An additional advantage of acoating1426 is a reduction in adverse reactions due to adhesion of platelets, proteins, cells or other fouling materials, which can cause fibrin clot production.
• As shown inFIG. 2A, if proximal force is applied to theactuating member1430 thedistal section1412 is deflected. This is due to theexpandable side1440 being able to expand while thenon-expandable side1438 is prevented from expanding. If theactuating member1430 is coupled with an actuating mechanism (not shown) such as a vernier type mechanism (not shown) a predictable and variable amount of deflection can be achieved with the application of a given amount of longitudinal force.FIG. 2B shows a lateral cross section of thevascular device1400 taken through thelines2B-2B and illustrates the locations of thenon-expandable side1438 andexpandable side1440.
• FIG. 3 shows avascular device400 which can be used as a guidewire or a catheter or as a combination of the two. Ahollow shaft402 defines afirst lumen414 into which is fitted an actuatingmember404 which is itself hollow and defines asecond lumen416. Thehollow shaft402 is proximally attached to afirst handle422 which, as described above, is used to contact thedevice400 as a whole. Athird handle423 is attached to the actuatingmember404 which provides longitudinal control over the position of the actuatingmember404. Thehollow shaft402 provides strength and support to thevascular device400 and defines aproximal termination402a, which is mounted within thefirst handle422, and adistal termination402b. Thehollow shaft402 and actuatingmember404 can be made from a variety of materials having sufficient strength to be able to cause thedistal section407 to deflect and still be flexible enough to move with acoil406, including but not limited to stainless steel alloys, nickel titanium alloys and reinforced polymeric materials such as Kevlar® or fabric materials. Thecoil406 defines anopen wound section406awhich is attached to and extends distally from thedistal termination402bof thehollow shaft402 to theproximal end412 of asolid coil section406b. Theopen wound section406ais further defined by the attachment of aribbon418 which in one embodiment is attached to a flattenedsection426 of thecoil406. Means of attaching theribbon418 include but are not limited to adhesives, laser welding, or soldering. In one embodiment, thecoil406 can be made from a radiopaque material such as a platinum-nickel alloy that allows the physician to visualize the position of thecoil406 using radiological means, thereby navigating thevascular device400 into desired anatomical pathways with minimal forward motion. Thevascular device400 defines a deflectabledistal section407 such that when longitudinal force is applied to the actuatingmember404 by the operator, thedistal section407 deflects as a result of preventing thenon-expandable side430, to which theribbon418 is attached, from expanding, while allowing theexpandable side432 to expand, resulting in thedistal section407 assuming a deflected configuration as best shown inFIGS. 3A and 3B. Theribbon418 is made of a suitable metallic material such as austenitic stainless steel alloy or a tungsten alloy such as tungsten-molybdenum and tungsten-rhenium. In some instances, iridium is added to the alloy to increase strength and radiopaqueness. In another embodiment (not shown) theribbon418 is not used and instead the deflectabledistal section407 is defined by a series of welds (not shown), gluing (not shown) or mechanical fasteners (not shown) affixed to the coil winds. In an alternative embodiment (not shown), theribbon418 is replaced by the application of a polymer fiber fused to the openwound coil section406a. The fiber (not shown) is entangled into the openwound coil section406aby means of weaving in and out of the coil winds and looping around the individual coil winds to form a solid attachment after application of an adhesive. The solid, distally locatedsection406bof thecoil406 is created by the presence ofwelds408 between the individual coil winds (unnumbered) which function to prevent flexing of thesolid section406bfrom the application of longitudinal force. Thesolid coil section406bterminates at adistal lumen opening410 which is in fluid communication with thesecond lumen416 and can thus be used to either deliver or aspirate substances from the anatomical area accessed by thedevice400. The actuatingmember404 extends proximally from thefirst handle422 allowing access to thesecond lumen416 and distally to the junction between theopen wound section406aandsolid section406bof thecoil406, where it is attached bysolder428. Extending through thesecond lumen416 is a rotatably mounted,flexible cutting shaft424, defining a proximal end424aand a distal end424bwhich terminates distally with a cuttingburr420 mounted thereon which is used to remove plaque or clots from a vessel. Asecond handle425 is distally attached to the cuttingshaft424 and is manually rotated by the physician as needed, resulting in the cuttingburr420 simultaneously rotating. Flexibility of the cuttingshaft424 is preferably provided by making it of superelastic nitinol, but it is also contemplated to be made of stainless steel, glass-filled polymer or carbon-filled polymer.
• When distal force is applied to the actuatingmember404 by the operator, as shown inFIG. 3A, thedistal section407 deflects due to thenon-expandable side430 to which theribbon418 is attached being prevented from expanding while allowing theexpandable side432 to expand, resulting in thedistal section407 assuming a deflected configuration as best shown inFIG. 3A. As shown inFIG. 3B, if proximal force is applied to the actuatingmember404 thedistal section407 is deflected in the opposite direction as when distal force is applied. This is due to the pitch of the openwound coil section406ahaving a relatively loose or open pitch to the coil winds (unnumbered), which allows the coil winds (unnumbered) on theexpandable side432, to be forced into a closer configuration. If the actuatingmember404 is coupled with an actuating mechanism (not shown) such as a vernier type mechanism (not shown) a predictable and variable amount of deflection can be achieved with the application of a given amount of longitudinal force.FIG. 3C shows a lateral cross section of thevascular device400 taken through thelines3C-3C and illustrates the locations of thenon-expandable side430 andexpandable side432.
• FIG. 4 is a cross sectional centerline view taken along the longitudinal axis of an alternative embodiment of thevascular device500 which is similar to the embodiment of thevascular device400 shown inFIGS. 3-3C, with the addition of a coveringsheath505. Thevascular device500 can be used as a guidewire or a catheter or as a combination of the two. Thesheath505 can be insert molded and surrounds at least thedistal section517 of thevascular device500. Thesheath505 functions to make thedevice500 more atraumatic, creating a safer device. Adistal end506 of thesheath505 defines a range of at least one and up to eightslits508 which are impressed across the center axis of thedistal end506 and which function to enclose a cuttinghead520 and thereby protect delicate anatomical structures during introduction. When the cuttinghead520 or other medical device (not shown) is deployed theslits508 will open, becoming flaps (not shown), allowing the physician to perform a medical procedure, such as loosening and ultimately removing plaque from the interior surfaces of artery walls. When the cuttinghead520 or other medical device (not shown) is pulled back into thesecond lumen516 following completion of the procedure, theflaps508 may close (not shown) or remain open still enclosing the cuttinghead520, allowing thedevice500 to be removed in a manner less likely to cause additional trauma to the patient.
• As shown inFIG. 4hollow shaft502 defines afirst lumen514 into which is fitted an actuatingmember504 which is itself hollow and defines asecond lumen516. Thehollow shaft502 and actuatingmember504 are proximally attached to afirst handle534 which is used to contact thedevice500 as a whole as well as allowing longitudinal control over the position of the actuatingmember504. Thehollow shaft502 provides strength and support to thevascular device500 as a whole and defines a proximal termination (unnumbered), which is mounted within thefirst handle534. Thehollow shaft502 and actuatingmember504 can be made from a variety of materials having sufficient strength to be able to cause thedistal section517 to deflect and still be flexible enough to move with acoil510, including but not limited to stainless steel alloys, nickel titanium alloys and reinforced polymeric materials such as Kevlar® or fabric materials. Thecoil510 defines anopen wound section510awhich is attached to and extends distally from the distal termination (unnumbered) of thehollow shaft502 to a proximal end (unnumbered) of asolid coil section510b. Theopen wound section510ais further defined by the attachment of aribbon518 which in one embodiment is attached to a flattenedsection526 of thecoil510. Means of attaching theribbon518 include but are not limited to adhesives, laser welding, or soldering. In one embodiment, thecoil510 can be made from a radiopaque material such as a platinum-nickel alloy that allows the physician to visualize the position of thecoil510 using radiological means, thereby navigating thevascular device500 into desired anatomical pathways with minimal forward motion. Thevascular device500 defines a deflectabledistal section517 so that when longitudinal force is applied to the actuatingmember504 by the operator, the deflectabledistal section517 deflects, as described in detail below. Theribbon518 is made of a suitable metallic material such as austenitic stainless steel alloy or a tungsten alloy such as tungsten-molybdenum and tungsten-rhenium. In some instances, iridium is added to the alloy to increase strength and radiopaqueness. In another embodiment (not shown) theribbon518 is not used and instead the deflectabledistal section517 is defined by a series of welds (not shown), gluing (not shown) or mechanical fasteners (not shown) affixed to the coil winds. In an alternative embodiment (not shown), theribbon518 is replaced by the application of a polymer fiber fused to the openwound coil section510a. The fiber (not shown) is entangled into the openwound coil section510aby means of weaving in and out of the coil winds and looping around the individual coil winds to form a solid attachment after application of an adhesive. The solid, distally locatedsection510bof thecoil510 is created in this embodiment by the presence ofwelds512 between the individual coil winds (unnumbered) which function to prevent flexing of thesolid section510bfrom the application of longitudinal force. Thesolid coil section510bterminates at a distal lumen opening (unnumbered) which is in fluid communication with thesecond lumen516 and can thus be used to either deliver or aspirate substances from the anatomical area accessed by thedevice500. The actuatingmember504 extends proximally from thefirst handle534 allowing access to thesecond lumen516 and distally to the junction between theopen wound section510aandsolid section510bof thecoil510, where it is attached bysolder528. Extending through thesecond lumen516 is a rotatably mounted cuttingshaft524, defining a proximal end524aand a distal end524bwhich terminates distally and is mounted with a cuttinghead520 and is used to remove plaque or clots from a vessel. Asecond handle536 is distally attached to the cuttingshaft524 and is manually rotated by the physician as needed, resulting in rotation of the cuttinghead520. Flexibility of the cuttingshaft524 is preferably provided by making it of superelastic nitinol, but it is also contemplated to be made of stainless steel, glass-filled polymer or carbon-filled polymer.
• When distal force is applied to the actuatingmember504 by the operator, as shown inFIG. 4B, thedistal section517 deflects due to thenon-expandable side530 to which theribbon518 is attached being prevented from expanding while allowing theexpandable side532 to expand, resulting in thedistal section517 assuming a deflected configuration as best shown inFIG. 4B. As shown inFIG. 4C, if proximal force is applied to the actuatingmember504 thedistal section517 is deflected in another direction as when distal force is applied. This is due to the pitch of the openwound coil section510ahaving a relatively loose or open pitch to the coil winds (unnumbered), which allows the coil winds (unnumbered) on theexpandable side532, to be forced into a closer configuration. If the actuatingmember504 is coupled with an actuating mechanism (not shown) such as a vernier type mechanism (not shown) a predictable and variable amount of deflection can be achieved with the application of a given amount of longitudinal force.FIG. 4D shows a lateral cross section of thevascular device500 taken through the lines4D-4D and illustrates the locations of thenon-expandable side530 andexpandable side532.
• FIG. 5A shows thevascular device400 as shown in more detail inFIG. 3 in use following introduction into a patient, approaching anobstruction1002 at the onset of treatment. It is seen that thedevice400 has been navigated to theobstruction1002 in avessel1000 which requires opening. Cuttinghead420 has been deployed from thesecond lumen416 to eventually bore through theobstruction1002 and it is observed that the distal end (unnumbered this figure) of thedevice400 is in the deflected configuration as a result of applying distal force to the actuatingmember404 which allows the device to be precisely navigated through a tortuous vascular pathway.
• FIG. 5B shows thevascular device400 in use during the beginning of treatment. It is seen that the deployed cuttinghead420 is being rotated and contacting theobstruction1002. It is further seen that some of theobstruction1002bhas been detached from its main body following treatment.
• FIG. 5C shows thevascular device400 in use following completion of treatment. It is seen that theobstruction1002 has been crossed and that someobstruction1002aremains attached to thevessel1000 wall whileother obstruction1002bis detached and has been removed.
• FIG. 5D shows thevascular device400 in use following introduction into a patient, approaching anobstruction1000 at the onset of treatment, with thevascular device400 contained in acatheter50 used to aspirate debris from the treatment site.
• FIG. 5E shows avascular device500 similar to that shown inFIG. 4 with an additional difference being apredetermined angle722 formed into the cuttingshaft718. It is seen that the deployed cuttinghead720 extends from theslit508 at thedistal end506 of thesheath505 and is being rotated and contacting theobstruction1002. Theangle722 confers the advantage of allowing the physician to rotate the proximal end (not shown) of the actuating member (not shown) causing the cuttinghead720 to move in an elliptical path around the inner walls of thevessel1000, cutting and removingobstruction1002. This allows thesheath505 to remain stationary and not rotated by the physician. A consistent deflection can be maintained on thedistal end506 of thevascular device500 and held in the center axis of thevessel1000. This advantage also reduces the amount of vascular damage caused by required rotating of conventional guidewires or cutting devices by the physician in the process of navigating thedevice500 through vascular obstructions.
• The outer diameter of thevascular device400,500,600,1400 is manufactured to dimensions that are industry standards for certain medical procedures and can range from between approximately 0.006 inch to 0.121 inch which allows passage through a ten French catheter at 0.131 inch outer diameter, as an example. The length of thevascular device400,500,600,1400 is similarly manufactured to conform to industry standards and may range between approximately 10 centimeters to 300 centimeters as required by the particular medical procedure.
• Use
• Using thevascular device400,500,600,1400 of the present invention first requires removal from sterile packaging. Standard surgical techniques are employed to incise the proper blood vessel or bodily duct using an introducer having one or more sealed ports. The introducer can range in diameter from 4 to 24 French depending on the vessel or bodily duct size and location. Most procedures performed for Percutaneous Transluminal Coronary Angioplasty (PTCA) use a 6 to 10 French device passing through the introducer. A 6 to 10 French catheter having an open and blunt distal end can cause vascular damage passing through the vessels. Therefore one embodiment of the invention described herein discloses a rounded, bulleted distal end. The introducer is placed into the vessel lumen and is followed by insertion of a guidewire, catheter or other medical device that can pass transluminally through the vessel to the site of therapy. A rounded distal end will facilitate this task with less vascular damage.
• Thevascular device400,500,600,1400 is then inserted into the introducer and carefully navigated through the patient's vasculature until the treatment site is reached. At that point, either thevascular device400,500,600,1400 is used to complete the procedure or another device is passed over or through thevascular device400,500,600,1400. At the completion of the procedure thevascular device400,500,600,1400 is disposed of.
• In theembodiments400,500 as described above, the invention may be employed as a combination guidewire and thrombectomy or atherectomy device to remove calcified plaque or venous thrombosis. When these embodiments of thevascular device400,500 are used the physician places thedistal end410,506 near the obstruction and a radio opaque contrast material may be injected into the artery through a lumen in the device, after which the physician advances asecond handle425,536 at the proximal end (unnumbered) to deploy the cuttinghead420,520 at thedistal end410,506 and slowly advance the device while manually rotating thesecond handle425,536. Aspiration may be used to remove the debris detached and displaced by the cuttinghead420,520. Upon completion of the procedure, thevascular device400,500 is removed and disposed of. These embodiments allow the physician to navigate a single device to the diseased area and complete the procedure in the shortest time with the least amount of vascular damage.
• While the invention as described above can be used as a combination guidewire/thrombectomy/atherectomy device, it can also be used a catheter. Most transfemoral coronary catheterization employ between a 4 and 10 French catheter. Small arteries will utilize around a 4 French catheter while larger arteries could utilize up to a 10 French catheter. Cited by the Journal of the American Medical Association, upward of three million cardiac catheterizations are performed annually in the United States. A device to reduce procedural time vascular damage would be an economic advantage to the industry. Thevascular device400,500,600,1400 may be applied to a variety of medical devices capable of being introduced into the vasculature or other anatomy of a patient. For example, thevascular device400,500,600,1400 could be applied to singular guidewires, guidewire/catheter combination (e.g., balloon angioplasty, stent deliver, drug delivery, fluid delivery or fluid removal), as a conduit for atherectomy devices and NUS catheters, laparoscopic and endoscopic devices, spinal or cranial navigation devices, neurostimulation and cardiac resynchronization leads, embolic protection devices, therapeutic devices and other medical devices. When used for drug delivery the invention finds utility by being able to remove fluid causing the surrounding area to lose excess fluid. A drug can then be injected and the affected area will more readily absorb the drug by the osmotic difference in pressure. This allows the drug to remain at the site rather than be carried away by the movement of interstitial fluids.
• Thevascular device600,1400 finds further utility in the implantation of neurostimulation or resynchronization leads which are typically 30 to 60 cm long. Currently these leads must include a large lumen for the insertion of a preformed stylet to steer the lead to the target site. As the industry continues to reduce the diameter of these leads to 4.1 French or less by removing the stylet lumen, a device is needed to steer the leads to the target site and allow the physician to rotate the lead (not shown) at the proximal end to implant the lead. Thevascular device600,1400 accomplishes this by providing an open lumen from the proximal end (unnumbered) to thedistal end620,1436 while allowing thedistal end620,1436 to be manipulatively deflected by the physician and the proximal end of the lead manually rotated. Following implantation of the lead the invention is removed and disposed of.

Claims (18)

1. A vascular device, comprising:

a. a shaft defining a longitudinal dimension, a lumen allowing fluid communication through the shaft extending along the longitudinal dimension, a proximal section and a distal section;

b. the distal section defining a weak side and a strong side; and

c. an actuating member attached to the distal section, the actuating member capable of transmitting longitudinal force to the distal section;

wherein applying longitudinal force to the actuating member causes the weak side of the distal section to increase in size while the strong side maintains substantially the same size, resulting in the distal section deflecting.

2. The vascular device ofclaim 1 wherein the actuating member is attached to a distal end of the distal section.

3. The vascular device ofclaim 1 wherein the vascular device in a non-stressed configuration has a straight configuration and applying distal force to the actuating member causes the distal section to deflect.

4. The vascular device ofclaim 1 wherein the vascular device in a non-stressed configuration has a straight configuration and applying proximal force to the actuating member causes the distal section to deflect.

5. The vascular device ofclaim 1 wherein at least the distal section comprises a coil defining a central space.

6. The vascular device ofclaim 5 wherein the strong side of the distal section is prevented from assuming a larger size by a ribbon attached to the coil, preventing the non-expandable side of the coil from expanding when longitudinal force is applied to the coil.

7. The vascular device ofclaim 6 wherein the ribbon is attached to the coil at a flattened area configured into the coil.

8. A vascular device, comprising:

a. a shaft defining a lateral dimension, a longitudinal dimension, a proximal section, a distal section having greater flexibility than the proximal section and a lumen allowing access through the shaft extending along the longitudinal dimension;

b. the shaft at least partly defining a coil, the coil further defining a distal end;

c. an actuating member attached to the coil, the actuating member capable of transferring longitudinal force to the coil; and

d. a side of the coil winds being physically connected, defining a connected side, to maintain the coil winds on the connected side in a constant configuration preventing differential spacing resulting from the application of longitudinal force and causing the connected coil winds to have a predetermined configuration in an unstressed state;

wherein the application of longitudinal force to the actuating member causes an unconnected side of the coil winds to expand, resulting in the vascular device assuming a stressed configuration having a different shape than the vascular device in the unstressed configuration.

9. The vascular device ofclaim 8 wherein the device in the unstressed state has a straight configuration and applying longitudinal force to the actuating member causes the distal section to deflect away from the longitudinal dimension.

10. The vascular device ofclaim 8 wherein the device in the unstressed state has an angled configuration and applying longitudinal force to the actuating member causes the distal section to deflect toward the longitudinal dimension.

11. The vascular device ofclaim 8 further comprising the side of the coil having connected coil winds being connected by a ribbon attached to the coil.

12. The vascular device ofclaim 10 wherein the ribbon resides in a recess formed into a section of the surface of the coil.

13. A vascular device, comprising:

a. a shaft defining a lateral dimension, a longitudinal dimension, a proximal section, a distal section having greater flexibility than the proximal section and a lumen allowing access through the shaft extending along the longitudinal dimension;

b. the shaft at least partly defining a coil, the coil further defining a distal end;

c. a flexible cutting shaft extending through the lumen, the cutting shaft defining a proximal end and a distal end, with a cutting burr attached to the distal end of the cutting shaft;

d. an actuating member attached to the coil, the actuating member capable of transferring longitudinal force to the coil;

e. a side of the coil winds being physically connected, defining a connected side, to maintain the coil winds on the connected side in a constant configuration preventing differential spacing resulting from the application of longitudinal force and causing the connected coil winds to have a predetermined configuration in an unstressed state;

wherein the application of longitudinal force to the actuating member causes an unconnected side of the coil winds to expand, resulting in the vascular device assuming a stressed configuration having a different shape than the vascular device in the unstressed configuration.

14. The vascular device ofclaim 13 wherein the device in the unstressed state has a straight configuration and applying longitudinal force to the actuating member causes the distal section to deflect away from the longitudinal dimension.

15. The vascular device ofclaim 13 further comprising the side of the coil having connected coil winds being connected by a ribbon attached to the coil.

16. The vascular device ofclaim 13 wherein the ribbon resides in a recess formed into a section of the surface of the coil.

17. The vascular device ofclaim 13 wherein the cutting shaft is made of superelastic nitinol.

18. The vascular device ofclaim 13 wherein at least the distal end is covered by a sheath.

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