US20160151182A9 - Anchoring Guidewire and Methods for Use - Google Patents
Anchoring Guidewire and Methods for Use Download PDFInfo
- Publication number
- US20160151182A9 US20160151182A9 US14/244,134 US201414244134A US2016151182A9 US 20160151182 A9 US20160151182 A9 US 20160151182A9 US 201414244134 A US201414244134 A US 201414244134A US 2016151182 A9 US2016151182 A9 US 2016151182A9
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- US
- United States
- Prior art keywords
- anchoring
- guidewire
- core
- basket
- compressed state
- Prior art date
- Legal status (The legal status is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the status listed.)
- Granted
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Classifications
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61F—FILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
- A61F2/00—Filters implantable into blood vessels; Prostheses, i.e. artificial substitutes or replacements for parts of the body; Appliances for connecting them with the body; Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents
- A61F2/95—Instruments specially adapted for placement or removal of stents or stent-grafts
- A61F2/954—Instruments specially adapted for placement or removal of stents or stent-grafts for placing stents or stent-grafts in a bifurcation
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
- A61M25/00—Catheters; Hollow probes
- A61M25/01—Introducing, guiding, advancing, emplacing or holding catheters
- A61M25/02—Holding devices, e.g. on the body
- A61M25/04—Holding devices, e.g. on the body in the body, e.g. expansible
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
- A61M25/00—Catheters; Hollow probes
- A61M25/01—Introducing, guiding, advancing, emplacing or holding catheters
- A61M25/09—Guide wires
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
- A61M25/00—Catheters; Hollow probes
- A61M25/01—Introducing, guiding, advancing, emplacing or holding catheters
- A61M25/09—Guide wires
- A61M2025/09125—Device for locking a guide wire in a fixed position with respect to the catheter or the human body
Definitions
- Guidewires may be utilized to direct medical devices into a desired target vessel for intervention.
- Conventional guidewire methods and devices may include a steerable guidewire that is not anchored in any way.
- the stiff device may work to straighten the guide wire as the device is advanced over the curved portion of the guide wire and the steerable guidewire may often slip back out of the target vessel making it difficult to use the steerable guidewire as a coaxial rail to guide a device into the appropriate vessel.
- the present invention is directed to methods and apparatus that may include an anchoring basket to anchor a guidewire to vasculature prior to graft deployment. These features may thereby improve the ease by which stent grafts can be placed in branched vessels and increase the speed and success of complex cases, while at the same time lowering the chance for complications.
- Anchoring the guidewire to the subject's vasculature may have a stabilizing effect for the tip of the catheter and afford greater stability and confidence for the operator.
- Once the anchoring basket is deployed it may be locked in place, securing the basket and may beneficially allow blood to continue to flow through the basket and downstream.
- the guidewire Once anchored, the guidewire may be used as a common coaxial rail for improved delivery of treatment devices such as bare metal stents, covered stents, and other over-the-wire devices.
- the present invention provides an anchoring guidewire comprising: (a) an outer core, (b) an anchoring basket, (c) a steerable tip, and (d) an actuator core, where the outer core, the anchoring basket and the steerable tip are axially aligned with one another, and where the actuator core is movably disposed within both the outer core and the anchoring basket, and where the actuator core is coupled to the steerable tip.
- the invention may provide that the anchoring basket comprises a plurality of strips defined in the outer core adjacent to the steerable tip, where the plurality of strips are substantially straight in a first neutral state and bow out in a radial direction in a second compressed state.
- the invention may provide that the anchoring basket comprises a plurality of wires each with a proximal end and a distal end, where each proximal end of the plurality of wires is attached to a first holder and each distal end of the plurality of wires is attached to a second holder, where the plurality of wires are substantially straight in a first neutral state and bow out in a radial direction in a second compressed state.
- the present invention also provides a method for deploying an anchoring guidewire, the method comprising: (a) introducing the anchoring guidewire according to the first aspect of the invention into an arterial configuration, (b) placing the actuator core under tension and causing the steerable tip to advance towards the outer core, and (c) moving the anchoring basket from a first neutral state to a second compressed state.
- FIG. 1A is a side view of the anchoring guidewire in a neutral state, in accordance with one embodiment of the invention.
- FIG. 1B is a side view of the anchoring guidewire in a compressed state, in accordance with one embodiment of the invention.
- FIG. 2A is a side view of a locking mechanism in a neutral state, in accordance with one embodiment of the invention.
- FIG. 2B is a side view of a locking mechanism in a compressed state, in accordance with one embodiment of the invention.
- FIG. 2C is a side view of a locking mechanism in a locked state, in accordance with one embodiment of the invention.
- FIG. 3 is a flow chart depicting functions that can be carried out in accordance with example embodiment of the disclosed methods.
- the present invention may take the form of an anchoring guidewire 100 comprising: (a) an outer core 102 , (b) an anchoring basket 104 , (c) a steerable tip 106 , and (d) an actuator core 108 .
- the outer core 102 , the anchoring basket 104 and the steerable tip 106 may be axially aligned with one another.
- the actuator core 108 may be movably disposed within both the outer core 102 and the anchoring basket 104 and may be coupled to the steerable tip 106 .
- the total length of the anchoring guidewire 100 may range from about 120 mm to about 10,000 mm.
- the outer core 102 may be made of, for example, polyurethane, a polyurethane with tungsten, gold, nitinol, platinum, stainless steel, stainless steel with nickel, tungsten or any other suitable material.
- the outer core 102 may have a diameter in the range from about 0.25 mm to about 1 mm, and preferably in the range from about 0.254 mm to about 0.9652 mm.
- a plurality of radiopaque markers may be disposed on the outer core 102 .
- This plurality of radiopaque markers may be arranged such that the plurality of radiopaque makers are spaced apart by 1 cm, for example, starting at the proximal end of the anchoring basket 104 and moving in a proximal direction in a range up to about 20 mm along the outer core 102 .
- the anchoring basket 104 may include a plurality of strips defined in the outer core 102 adjacent to the steerable tip 106 . These strips may be created by laser cutting the outer core 102 . The strips may be substantially straight in a first neutral state (as shown in FIG. 1A ) and may bow out in a radial direction in a second compressed state (as shown in FIG. 1B ).
- the anchoring basket 104 may include a plurality of wires each with a proximal end and a distal end.
- This plurality of wires may be made of, for example, nitinol, titanium, titanium alloys, various plastics or any other suitable material.
- each proximal end of the plurality of wires may be attached to a first holder 110 and each distal end of the plurality of wires may be attached to a second holder 112 .
- the plurality of wires may be coupled directly to the outer core 102 and to the steerable tip 106 .
- the plurality of wires may be substantially straight in a first neutral state (as shown in FIG.
- the anchoring basket 104 may have a diameter in the second compressed state ranging from about 3 mm to about 70 mm.
- the first holder 110 may be in mechanical communication with the outer core 102 and the second holder 112 may be in mechanical communication with the steerable tip 106 .
- the outer core 102 may be physically coupled to the first holder 110 and the steerable tip 106 may likewise be physically coupled to the second holder 112 .
- the actuator core 108 may be movably disposed within the outer core 102 and extend through the anchoring basket 104 such that the actuator core 108 may be coupled to the steerable tip 106 and/or the second holder 112 .
- the actuator core 108 may cause the anchoring basket 104 to move between the first neutral state and the second compressed state.
- FIG. 1A illustrates the first neutral state of the anchoring guidewire 100
- FIG. 1B illustrates the second compressed state of the anchoring guidewire 100 .
- the actuator core 108 may be positioned to allow it to cause the steerable tip 206 to advance towards the outer core 102 until the anchoring basket 104 is in the second compressed state.
- the actuator core 108 may be positioned to allow it to cause the second holder 112 to advance towards the first holder 110 until the anchoring basket 104 is in the second compressed state.
- FIGS. 2A-2C illustrate an example locking mechanism in accordance with one embodiment of the invention.
- the actuator core 108 may be in physical communication with a releasable locking mechanism to hold the anchoring basket 104 in the second compressed state.
- the releasable locking mechanism may include a raised element or protrusion 114 coupled to the actuator core 108 .
- the raised element or protrusion 114 may be configured to fit within a slot 116 in the outer core 102 .
- the actuator core 108 and thereby the raised element 114 may be pulled in a proximal direction relative to the outer core 102 , then rotated such that an interference fit (shown in FIG. 2C ) with the outer core 102 prevents the raised element 114 from moving distally.
- the actuator core 108 may be locked in position and hold the anchoring basket 104 in the second compressed state.
- the wires 105 are spring-loaded such that they seek to return to the first neutral state.
- the second holder 112 is positioned to allow it to cause the steerable tip 106 to advance away from the outer core 102 until the first neutral state is achieved.
- the actuator core 108 may have a stiffness such that the actuator core 108 may be capable of both pushing and pulling the steerable tip 106 .
- the actuator core 108 and/or the spring force in the plurality of wires may cause the wire anchor basket 104 to return to the first neutral state.
- the steerable tip 106 may have various stiffness and thickness to account for different use cases. For example, the steerable tip 106 may be thinner and/or less stiff in a case where the anchoring guidewire 100 must navigate a tight turn to advance to the target vessel. In another example, the steerable tip 106 may be thicker and/or stiffer in a case where the target vessel is less delicate and there is a more direct route to the target vessel.
- the steerable tip 206 may have a length in the range from about 5 mm to about 200 mm.
- FIG. 3 is a simplified flow chart illustrating a method according to an exemplary embodiment. Although the blocks are illustrated in a sequential order, these blocks may also be performed in parallel, and/or in a different order than those described herein. Also, the various blocks may be combined into fewer blocks, divided into additional blocks, and/or removed based upon the desired implementation.
- the method involves introducing the anchoring guidewire according to any one of the foregoing embodiments into any appropriate arterial configuration, including a synthetic lumen.
- the method involves placing the actuator core under tension and causing the steerable tip to advance towards the outer core.
- the method involves moving the anchoring basket from a first neutral state to a second compressed state.
- the method involves locking the actuator core in place to hold the anchoring basket in the second compressed state.
- the actuator core may be locked in place using the example locking mechanism described above in relation to FIGS. 2A-2C , or through some other locking mechanism.
- the method may further include the step of unlocking the actuator core.
- the method may further include removing tension from the actuator core and moving the anchoring basket from the second compressed state to the first neutral state.
Abstract
Description
- This application is a non-provisional of and claims priority to U.S. Provisional Application No. 61/809,134 entitled “Anchoring Guidewire,” filed on Apr. 5, 2013, which is hereby incorporated by reference in its entirety.
- Guidewires may be utilized to direct medical devices into a desired target vessel for intervention. Conventional guidewire methods and devices may include a steerable guidewire that is not anchored in any way. When tortuous anatomies are involved, the stiff device may work to straighten the guide wire as the device is advanced over the curved portion of the guide wire and the steerable guidewire may often slip back out of the target vessel making it difficult to use the steerable guidewire as a coaxial rail to guide a device into the appropriate vessel.
- The present invention is directed to methods and apparatus that may include an anchoring basket to anchor a guidewire to vasculature prior to graft deployment. These features may thereby improve the ease by which stent grafts can be placed in branched vessels and increase the speed and success of complex cases, while at the same time lowering the chance for complications. Anchoring the guidewire to the subject's vasculature may have a stabilizing effect for the tip of the catheter and afford greater stability and confidence for the operator. Once the anchoring basket is deployed it may be locked in place, securing the basket and may beneficially allow blood to continue to flow through the basket and downstream. Once anchored, the guidewire may be used as a common coaxial rail for improved delivery of treatment devices such as bare metal stents, covered stents, and other over-the-wire devices.
- Thus, in a first aspect, the present invention provides an anchoring guidewire comprising: (a) an outer core, (b) an anchoring basket, (c) a steerable tip, and (d) an actuator core, where the outer core, the anchoring basket and the steerable tip are axially aligned with one another, and where the actuator core is movably disposed within both the outer core and the anchoring basket, and where the actuator core is coupled to the steerable tip.
- In one embodiment, the invention may provide that the anchoring basket comprises a plurality of strips defined in the outer core adjacent to the steerable tip, where the plurality of strips are substantially straight in a first neutral state and bow out in a radial direction in a second compressed state.
- In another embodiment, the invention may provide that the anchoring basket comprises a plurality of wires each with a proximal end and a distal end, where each proximal end of the plurality of wires is attached to a first holder and each distal end of the plurality of wires is attached to a second holder, where the plurality of wires are substantially straight in a first neutral state and bow out in a radial direction in a second compressed state.
- In a second aspect, the present invention also provides a method for deploying an anchoring guidewire, the method comprising: (a) introducing the anchoring guidewire according to the first aspect of the invention into an arterial configuration, (b) placing the actuator core under tension and causing the steerable tip to advance towards the outer core, and (c) moving the anchoring basket from a first neutral state to a second compressed state.
-
FIG. 1A is a side view of the anchoring guidewire in a neutral state, in accordance with one embodiment of the invention. -
FIG. 1B is a side view of the anchoring guidewire in a compressed state, in accordance with one embodiment of the invention. -
FIG. 2A is a side view of a locking mechanism in a neutral state, in accordance with one embodiment of the invention. -
FIG. 2B is a side view of a locking mechanism in a compressed state, in accordance with one embodiment of the invention. -
FIG. 2C is a side view of a locking mechanism in a locked state, in accordance with one embodiment of the invention. -
FIG. 3 is a flow chart depicting functions that can be carried out in accordance with example embodiment of the disclosed methods. - Exemplary methods and systems are described herein. It should be understood that the word “exemplary” is used herein to mean “serving as an example, instance, or illustration.” Any embodiment or feature described herein as “exemplary” is not necessarily to be construed as preferred or advantageous over other embodiments or features. The exemplary embodiments described herein are not meant to be limiting. It will be readily understood that certain aspects of the disclosed systems and methods can be arranged and combined in a wide variety of different configurations, all of which are contemplated herein.
- Furthermore, the particular arrangements shown in the Figures should not be viewed as limiting. It should be understood that other embodiments may include more or less of each element shown in a given Figure. Further, some of the illustrated elements may be combined or omitted. Yet further, an exemplary embodiment may include elements that are not illustrated in the Figures.
- In a first aspect, as shown in
FIGS. 1A-B , the present invention may take the form of ananchoring guidewire 100 comprising: (a) anouter core 102, (b) ananchoring basket 104, (c) asteerable tip 106, and (d) anactuator core 108. Theouter core 102, theanchoring basket 104 and thesteerable tip 106 may be axially aligned with one another. Further, theactuator core 108 may be movably disposed within both theouter core 102 and theanchoring basket 104 and may be coupled to thesteerable tip 106. The total length of theanchoring guidewire 100 may range from about 120 mm to about 10,000 mm. - As used herein, with respect to measurements and calculations, “about” means ±5%.
- The
outer core 102 may be made of, for example, polyurethane, a polyurethane with tungsten, gold, nitinol, platinum, stainless steel, stainless steel with nickel, tungsten or any other suitable material. Theouter core 102 may have a diameter in the range from about 0.25 mm to about 1 mm, and preferably in the range from about 0.254 mm to about 0.9652 mm. In some embodiments, a plurality of radiopaque markers may be disposed on theouter core 102. This plurality of radiopaque markers may be arranged such that the plurality of radiopaque makers are spaced apart by 1 cm, for example, starting at the proximal end of theanchoring basket 104 and moving in a proximal direction in a range up to about 20 mm along theouter core 102. - In one embodiment, the
anchoring basket 104 may include a plurality of strips defined in theouter core 102 adjacent to thesteerable tip 106. These strips may be created by laser cutting theouter core 102. The strips may be substantially straight in a first neutral state (as shown inFIG. 1A ) and may bow out in a radial direction in a second compressed state (as shown inFIG. 1B ). - In another embodiment, the
anchoring basket 104 may include a plurality of wires each with a proximal end and a distal end. This plurality of wires may be made of, for example, nitinol, titanium, titanium alloys, various plastics or any other suitable material. In one embodiment, each proximal end of the plurality of wires may be attached to afirst holder 110 and each distal end of the plurality of wires may be attached to asecond holder 112. In an alternative embodiment, the plurality of wires may be coupled directly to theouter core 102 and to thesteerable tip 106. The plurality of wires may be substantially straight in a first neutral state (as shown inFIG. 1A ) and bow out in a radial direction in a second compressed state as thefirst holder 110 andsecond holder 112 are moved closer to one another (as shown inFIG. 1B ). Theanchoring basket 104 may have a diameter in the second compressed state ranging from about 3 mm to about 70 mm. Thefirst holder 110 may be in mechanical communication with theouter core 102 and thesecond holder 112 may be in mechanical communication with thesteerable tip 106. In some embodiments, theouter core 102 may be physically coupled to thefirst holder 110 and thesteerable tip 106 may likewise be physically coupled to thesecond holder 112. - The
actuator core 108 may be movably disposed within theouter core 102 and extend through theanchoring basket 104 such that theactuator core 108 may be coupled to thesteerable tip 106 and/or thesecond holder 112. In operation, theactuator core 108 may cause theanchoring basket 104 to move between the first neutral state and the second compressed state.FIG. 1A illustrates the first neutral state of the anchoringguidewire 100, andFIG. 1B illustrates the second compressed state of the anchoringguidewire 100. In one embodiment, theactuator core 108 may be positioned to allow it to cause the steerable tip 206 to advance towards theouter core 102 until the anchoringbasket 104 is in the second compressed state. In another embodiment, theactuator core 108 may be positioned to allow it to cause thesecond holder 112 to advance towards thefirst holder 110 until the anchoringbasket 104 is in the second compressed state. -
FIGS. 2A-2C illustrate an example locking mechanism in accordance with one embodiment of the invention. Specifically, theactuator core 108 may be in physical communication with a releasable locking mechanism to hold theanchoring basket 104 in the second compressed state. As shown inFIG. 2A , the releasable locking mechanism may include a raised element orprotrusion 114 coupled to theactuator core 108. In the first neutral state, the raised element orprotrusion 114 may be configured to fit within aslot 116 in theouter core 102. As shown inFIGS. 2B-2C , as the anchoringguidewire 100 moves from the first neutral state to the second compressed state, theactuator core 108 and thereby the raisedelement 114 may be pulled in a proximal direction relative to theouter core 102, then rotated such that an interference fit (shown inFIG. 2C ) with theouter core 102 prevents the raisedelement 114 from moving distally. The net result of this is that theactuator core 108 may be locked in position and hold theanchoring basket 104 in the second compressed state. When the plurality ofwires 105 of the anchoringbasket 104 are in the second compressed state, thewires 105 are spring-loaded such that they seek to return to the first neutral state. As such, when a tension in theactuator core 108 is removed, thesecond holder 112 is positioned to allow it to cause thesteerable tip 106 to advance away from theouter core 102 until the first neutral state is achieved. - In one embodiment, the
actuator core 108 may have a stiffness such that theactuator core 108 may be capable of both pushing and pulling thesteerable tip 106. Here, theactuator core 108 and/or the spring force in the plurality of wires may cause thewire anchor basket 104 to return to the first neutral state. - The
steerable tip 106 may have various stiffness and thickness to account for different use cases. For example, thesteerable tip 106 may be thinner and/or less stiff in a case where the anchoringguidewire 100 must navigate a tight turn to advance to the target vessel. In another example, thesteerable tip 106 may be thicker and/or stiffer in a case where the target vessel is less delicate and there is a more direct route to the target vessel. The steerable tip 206 may have a length in the range from about 5 mm to about 200 mm. -
FIG. 3 is a simplified flow chart illustrating a method according to an exemplary embodiment. Although the blocks are illustrated in a sequential order, these blocks may also be performed in parallel, and/or in a different order than those described herein. Also, the various blocks may be combined into fewer blocks, divided into additional blocks, and/or removed based upon the desired implementation. - At
block 302, the method involves introducing the anchoring guidewire according to any one of the foregoing embodiments into any appropriate arterial configuration, including a synthetic lumen. Atblock 304 the method involves placing the actuator core under tension and causing the steerable tip to advance towards the outer core. Atblock 306, the method involves moving the anchoring basket from a first neutral state to a second compressed state. Atblock 308, the method involves locking the actuator core in place to hold the anchoring basket in the second compressed state. The actuator core may be locked in place using the example locking mechanism described above in relation toFIGS. 2A-2C , or through some other locking mechanism. In another embodiment, the method may further include the step of unlocking the actuator core. In still another embodiment, the method may further include removing tension from the actuator core and moving the anchoring basket from the second compressed state to the first neutral state. - While various aspects and embodiments have been disclosed herein, other aspects and embodiments will be apparent to those skilled in the art. All embodiments within and between different aspects of the invention can be combined unless the context clearly dictates otherwise. The various aspects and embodiments disclosed herein are for purposes of illustration and are not intended to be limiting, with the true scope and spirit being indicated by the following claims.
Claims (20)
Priority Applications (1)
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US14/244,134 US10004621B2 (en) | 2013-04-05 | 2014-04-03 | Anchoring guidewire and methods for use |
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US201361809134P | 2013-04-05 | 2013-04-05 | |
US14/244,134 US10004621B2 (en) | 2013-04-05 | 2014-04-03 | Anchoring guidewire and methods for use |
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US20150282966A1 US20150282966A1 (en) | 2015-10-08 |
US20160151182A9 true US20160151182A9 (en) | 2016-06-02 |
US10004621B2 US10004621B2 (en) | 2018-06-26 |
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JP6820612B2 (en) | 2015-10-30 | 2021-01-27 | セレバスク,インコーポレイテッド | Hydrocephalus treatment system and method |
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Also Published As
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US10004621B2 (en) | 2018-06-26 |
US20150282966A1 (en) | 2015-10-08 |
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