This application relates to medical devices, and in particular to wire guides and methods of using wire guides.
Wire guides are commonly used in vascular procedures to introduce a wide variety of medical devices into the vascular system. For example, wire guides may be used in angioplasty procedures, diagnostic and interventional procedures, percutaneous access procedures, or radiological and neuroradiological procedures in general.
A traditional wire guide may include an elongated core element with one or more tapered sections near its distal end and a flexible helical coil disposed about the distal portion of the core element. The distal end of the core element or a separate safety ribbon which is secured to the distal end of the core element may extend through the flexible coil and be secured to a distal end member of the wire guide, such as a rounded member disposed at the distal end of the helical coil. In addition, the wire guide may include a handle at the proximal end of the core element to rotate, and thereby steer the wire guide as it is being advanced through a patient's vascular system.
Wire guides may encounter various challenges as they are steered through a patient's vascular system or other body lumen. For example, a procedure may require a physician to steer a wire guide through tortuous passageways before reaching a destination. In such a procedure, the wire guide needs sufficient stiffness to be pushed along the path while remaining flexible enough to pass through the tortuous passageways without causing damage. Additionally, the patient's vascular system or other bodily lumen may contain occlusions that impede the wire guide along its path. Some wire guides may struggle to pass through occlusions. These occlusions may also impede fluid flow. Therefore, a need exists for an improved wire guide for passing through and/or clearing occlusions.
In one implementation, a medical wire guide is provided that includes a mandrel, a cannula disposed about a portion of the mandrel, and a spring coupled with the mandrel. The spring is configured to be placed in a loaded state in response to relative displacement between the mandrel and the cannula. The spring is also configured to bias the mandrel in a distal direction relative to the cannula upon release of the spring from the loaded state.
In another implementation, a medical wire guide is provided that includes a mandrel, a cannula disposed about a first portion of the mandrel, and a spring disposed about a second portion of the mandrel. The mandrel is movable relative to the cannula to place the spring in a loaded state. The cannula comprises a first recess, and the mandrel comprises a protuberance engagable with the first recess. The spring is held in the loaded state when the protuberance is engaged with the first recess. The spring biases the mandrel forward in a distal direction relative to the cannula upon disengagement of the protuberance from the first recess.
In yet another implementation, a method of using a medical wire guide is provided. A spring of the medical wire guide is placed in a loaded state by retracting a mandrel of the medical wire guide. A distal tip of the medical wire guide, disposed at a distal end of the mandrel, is positioned to be within a spring range of an occlusion in a body lumen. The spring is released from the loaded state to bias the distal tip against the occlusion.
The components in the figures are not necessarily to scale. Moreover, in the figures, like referenced numerals designate corresponding parts throughout the different views.
For the purposes of promoting an understanding of the principles of the invention, reference will now be made to the embodiments illustrated in the drawings and specific language will be used to describe the same. It will nevertheless be understood that no limitation of the scope of the invention is thereby intended, and alterations and modifications in the illustrated device, and further applications of the principles of the invention as illustrated therein are herein contemplated as would normally occur to one skilled in the art to which the invention relates.
As used herein, the term “proximal” refers to a portion of the wire guide (or a portion of any device component) closest to a physician when placing a wire guide in a patient, and the term “distal” refers to a portion of the wire guide (or a portion of any device component) closest to the end inserted into the patient's body.
The mandrel 104 may comprise a core wire or solid shaft with a distal end and a proximal end. The distal tip 110 may be disposed at the distal end of the mandrel 104. A handle 112 may be disposed at the proximal end of the mandrel 104. The handle 112 may be used to push the mandrel 104 in a distal direction, pull the mandrel 104 in a proximal direction, or twist the mandrel 104.
The mandrel 104 may be formed of a suitable metallic material such as medical grade stainless steel, a stainless steel alloy, a super-elastic material including a nickel-titanium alloy (e.g., Nitinol), a linear-elastic material, or combinations of these materials. In other implementations, other suitable mandrel materials may be used. The mandrel 104 may include a radiopaque material, such as platinum or gold. Inclusion of a radiopaque material may increase the visibility of the wire guide 102 within the body of a patient. In some implementations, a radiopaque material may be included in other portions of the wire guide 102, such as in the cannula 106, the spring 108, and/or the distal tip 110.
The mandrel 104 may take one of many different shapes. In some implementations, the mandrel 104 has a circular cross-sectional shape. In other implementations, the mandrel 104 has a rectangular cross-sectional shape. In yet other implementations, the cross-section of the mandrel 104 assumes different shapes along the length of the mandrel 104.
The mandrel 104 may have a cross-sectional area that remains substantially constant along its length. Alternatively, the mandrel 104 may have a cross-sectional area that varies along its length. In one implementation, the mandrel 104 has a cross-sectional area that diminishes gradually or stepwise at increasing distances from the proximal end of the wire guide 102 such that the mandrel 104 tapers to a smaller diameter toward its distal end. For example, as shown in
The cannula 106 is disposed about a portion of the mandrel 104. The cannula 106 may be a sheath, tube, helical coil, or a combination thereof. The cannula 106 may be compressible or uncompressible. In one implementation, the cannula 106 comprises a solid tube. In another implementation, the cannula 106 comprises a coil wrapped around the mandrel 104. The cannula 106 may be manufactured from stainless steel, a stainless steel alloy, a nickel-titanium alloy (e.g., Nitinol), or combinations of these materials. In other implementations, other cannula materials may be used.
The cannula 106 is sized to receive the portion of the mandrel 104 such that the mandrel 104 is longitudinally movable relative to the cannula 106. In this way, a physician may use the handle 112 to push, pull, or twist the mandrel 104 relative to the cannula 106. In one implementation, the mandrel 104 may be coated with a material to allow it to slide through the cannula 106 more easily. In another implementation, the inner surface of the cannula 106 may be coated. The coating may be a material that reduces the coefficient of friction between the mandrel 104 and the cannula 106. For example, the coating may include a polymer, such as a fluoropolymer. In one implementation, the coating may be polytetrafluoroethylene (“PTFE”).
The distal tip 110 is disposed at a distal end of the mandrel 104. In one implementation, the distal tip 110 is an integral portion of the mandrel 104. In another implementation, the distal tip 110 is connected with the mandrel 104. For example, the distal tip 110 may be attached to the mandrel 104 by adhesive, solder, laser welding, or other attachment method. In one implementation, the distal tip 110 comprises an atraumatic shape, such as a rounded front or a front of flexible material that provides blunt force for dislodging or clearing occlusions. For example, the distal tip 110 may be a solder ball or a sphere. In another implementation, the distal tip 110 may have a shape that is designed to pierce through occlusions. For example, the distal tip 110 may be a spear, sharpened end, or other pointed structure.
The spring 108 is disposed about a distal portion of the mandrel 104 between the distal end of the cannula 106 and the distal tip 110. For example, as shown in
The spring 108 may be a compression spring formed from any material suitable for forming compression springs, such as stainless steel, alloys including stainless steel, a nickel-titanium alloy (e.g., Nitinol), or combinations of these materials. In other implementations, other spring materials may be used. For example, the spring may be a micro or miniature type spring made by the Motion Dynamics Corporation.
In one implementation, the proximal end (or other proximal portion) of the spring 108 is fixed to the distal end of cannula 106 and the distal end (or other distal portion) of the spring 108 is fixed to the distal tip 110 in a suitable manner as is known in the art, for example, by welding, soldering, or a brazed joint. Alternatively, the proximal end (or other proximal portion) of the spring 108 may be fixed to the mandrel 104. In another implementation, the ends of the spring 108 may rest against the distal end of cannula 106 and the distal tip 110. In other implementations, different suitable spring connection systems may be used.
The spring 108 may be configured to push the distal tip 110 forward in a distal direction in a desired manner. For example, in one implementation, the spring 108 may extend up to an inch or two very quickly. In other implementations, the spring 108 may extend more than two inches very quickly. The spring 108 may be formed to have a spring constant that provides a desired biasing force according to Hooke's law, F=−kx, where F represents the force exerted by the spring 108 when released, k represents the spring constant, and x represents the distance that the spring 108 is compressed from a relaxed state. To increase the force provided by the spring 108, the spring 108 may be compressed to a greater degree before release or may be formed to have a larger spring constant. In some implementations, a large spring force may be desired to help clear or pass through occlusions in the vascular system. In other implementations, a smaller spring force may be desired to avoid damage to the vascular system. The spring compression degree and spring constant may therefore be selected or varied to meet the needs of the intended application for the wire guide 102.
In one implementation, the trigger mechanism 304 includes a first recess 402 located on the cannula 106 at a predetermined location near the proximal end of the cannula 106. The first recess 402 is configured to receive and engage a protuberance 404 on the mandrel 104 so as to hold the spring 108 in its compressed state. The trigger mechanism 304 also includes a longitudinal slot 405 located on the cannula 106, the proximal end of the longitudinal slot 405 being adjacent the first recess 402. The longitudinal slot 405 is configured to guide the protuberance 404 toward the first recess 402 when a user pulls the mandrel 104 in a proximal direction to compress the spring 108 from its substantially relaxed state. In operation, a user pulls the mandrel 104 in a proximal direction to compress the spring 108 until the protuberance 404 reaches the first recess 402, at which time the user twists the mandrel 104 so as to position the protuberance 404 in the first recess 402. Subsequently, when the user releases the mandrel 104, the protuberance 404 is engaged within first recess 402 under the bias of the spring 108 so as to hold the spring 108 in its compressed state. As shown in
The location of the recess 402 may be selected to achieve the desired degree of compression when the spring 108 is in the compressed or loaded state. In implementations that desire a high degree of spring compression, the recess 402 may be located relatively close to the proximal end of the wire guide 302. In implementations that desire a lesser degree of spring compression, the recess 402 may be located relatively further from the proximal end of the wire guide 302. The trigger mechanism 304 may also include additional recesses similar to the recess 402 to allow for a user-selected amount of spring compression.
In some implementations, the trigger mechanism 304 may also include a second recess 406 located on the cannula 106 at a predetermined location adjacent the distal end of the longitudinal slot to hold the spring in a substantially relaxed state when the protuberance 404 engages the second recess 406. In other implementations, the protuberance that engages with the second recess 406 may be different than the protuberance 404 that engages with the first recess 402. The location of the second recess 406 may be selected to achieve the desired degree of flexibility in the spring 108 in a substantially relaxed state. In implementations that desire a relatively high degree of wire guide tip flexibility, the second recess 406 may be located at a position that holds the spring 108 in a relaxed state to provide a highly flexible wire guide tip. In implementations that desire a lesser degree of wire guide tip flexibility, the second recess 406 may be located at a position that partially compresses the spring 108 to provide a stiffer wire guide tip. Similarly, in implementations that desire a stiff wire guide tip, the user may engage the protuberance 404 with the first recess 402 to place the spring in the compressed state. The spring 108 provides a greater stiffness in the compressed state than it does in a substantially relaxed state. Therefore, the wire guide 302 may provide a variable range of distal tip flexibility based on the degree of compression in the spring 108.
In the wire guide 602, the spring 608 is disposed about a proximal portion of the mandrel 604. Placing the spring 608 near the proximal end of the wire guide 602 allows the spring 608 to be nearer to the user and may provide the user with improved control. The spring 608 may be a tension spring formed from any material suitable for forming tension springs, such as stainless steel, alloys including stainless steel, a nickel-titanium alloy (e.g., Nitinol), or combinations of these materials. In other implementations, other elastic spring materials may be used.
The spring 608 may be coupled between a collar 605 mounted on the proximal portion of the mandrel 604 and the proximal end of the cannula 606. In one implementation, the proximal end (or other proximal portion) of the spring 608 is fixed to the collar 605 and the distal end (or other distal portion) of the spring 608 is fixed to the proximal end of cannula 106 in a suitable manner as is known in the art, for example, by welding, soldering, or a brazed joint. In other implementations, another spring connection system may be used. Alternatively, the proximal end (or other proximal portion) of the spring 608 may be fixed to the handle 610.
The spring 608 may be formed to have a spring constant that provides a desired biasing force according to Hooke's law, F=−kx, where F represents the force exerted by the spring 608 when released, k represents the spring constant, and x represents the distance that the spring 608 is stretched from a relaxed state. To increase the force provided by the spring 608, the spring 608 may be stretched to a greater degree before release or may be formed to have a larger spring constant. In some implementations, a large spring force is desired to help clear or pass through occlusions in the vascular system. In other implementations, a smaller spring force may be desired to avoid damage to the vascular system. The spring extension degree and spring constant may therefore be selected or varied to meet the needs of the intended application for the wire guide 602.
Although not shown in
At act 902, a spring of the wire guide is compressed or stretched. The spring of the wire guide 302 or 602 may be compressed or stretched either before insertion of the device into the patient's vascular system or after insertion of the device into the patient's vascular system. In one implementation, a user may pull the mandrel 104 of the wire guide 302 in a proximal direction to retract the distal tip 110 and place the spring 108 into a compressed state. The spring 108 may be compressed between the distal tip 110 and some other support structure, such as the cannula 106 of the wire guide 302. In another implementation, a user may pull the mandrel 604 or handle 610 of the wire guide 602 in a proximal direction to place the spring 608 into an extended state. The amount of force that is provided by the spring is dependent on the amount of compression or extension in the spring. The user may control the amount of spring force created by controlling the amount of compression/extension provided to the spring. In one implementation, a small spring force may be desired. Therefore, the user may only compress/stretch the spring a relatively small amount. In other implementations, a larger spring force may be desired. Therefore, the user may compress/stretch the spring a relatively larger amount.
At act 904, the spring is held in the compressed or extended state. In one implementation, a user may engage the mandrel 104 with a trigger mechanism 304 to hold the spring 108 in the compressed state. In another example, a user may engage the mandrel 604 with a trigger mechanism to hold the spring 608 in the extended state.
At act 906, the wire guide 302 or 602 is positioned within a patient's vascular system. The wire guide 302 or 602 may be positioned within a patient's vascular system at act 906 before and/or after the spring of the wire guide 302 or 602 is placed in the loaded state at act 902. For example, in one implementation, the user may first position the distal tip of the wire guide to be near the occlusion before placing the spring in the loaded state. In another implementation, the spring may be placed in the loaded state before the distal tip is positioned to be near the occlusion.
In one implementation, a user may position the distal tip 110 of the wire guide 302 to be within a spring extension range of an occlusion in a vascular passage. The spring extension range may be the distance that the spring 108 may propel the distal tip 110 forward in a distal direction when the spring 108 is released from the compressed state. In another implementation, a user may position the distal tip 802 of the wire guide 602 to be within a spring recoil range of an occlusion in a vascular passage. The spring recoil range may be the distance that the spring 608 may propel the distal tip 802 forward in a distal direction when the spring 608 is released from the extended state.
At act 908, the spring of the wire guide is released from the compressed or extended state. In one implementation, the spring 108 is released from the compressed state. In another implementation, the spring 608 is released from the extended state. When released from the compressed or extended state, the spring propels the distal tip forward in a distal direction. The spring may be configured to extend from the compressed state quickly. The quick movement of the spring may allow the distal tip to penetrate the occlusion. Because the distal tip may be positioned to be within the spring extension or recoil range of the occlusion at act 906, the distal tip may make contact with the occlusion when propelled by the spring. In some instances, the spring 108 will push the distal tip against the occlusion without passing through the occlusion. In other instances, the spring will push the distal tip through the occlusion. A user may also twist the mandrel connected with the distal tip to apply a drilling motion from the distal tip to the occlusion.
At act 910, it is determined whether the occlusion has been sufficiently cleared. The user may determine whether a large enough passage has been created by the spring action of the wire guide. If the user determines that the occlusion has not been sufficiently cleared at act 910, then the spring may be recompressed/stretched at act 902 for a second attempt at clearing the occlusion. This recompression/stretching may occur while the distal tip remains within the patient. After one or more compressions/stretches and releases of the spring, the user may determine that the occlusion is sufficiently cleared. When that occurs, the user may continue feeding the wire guide through the patient's vascular system to the desired destination at act 912. In some instances, the objective of the procedure may be to clear one or more occlusions. In that case, the wire guide 302 would be steered to the next occlusion and the spring action occlusion clearing process may begin again for the next occlusion.
At various points in the procedure, the user may slide other medical devices over the wire guide into the patient. In one implementation, the user may slide tubing along the wire guide to the location of the occlusion. The tubing may then be used as a passageway to remove material that may become dislodged from the occlusion by the spring action wire guide. Alternatively, the tubing may be used to support a weak vessel or deliver material to a desired location within the patient.
Although the invention has been described and illustrated with reference to specific illustrative embodiments thereof, it is not intended that the invention be limited to those illustrative embodiments. For example,
The medical devices described herein may be dimensioned to fit within a vascular passage or other body lumen. The wire guide may generally have a length in the range of 30-600 cm. In some implementations, the length of the wire guide may be in the range of 90-300 cm. The wire guide may generally have an outer diameter in the range of 0.204-1.321 mm (0.008-0.052 inches). In some implementations, the outer diameter may be in the range of 0.254-2.286 mm (0.01-0.09 inches). For example, one type of wire guide may have an outer diameter of about 0.889 mm (0.035 inches).
This application claims the benefit of U.S. Provisional Application No. 61/224,236, filed Jul. 9, 2009, which is hereby incorporated by reference.
Filing Document | Filing Date | Country | Kind | 371c Date |
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PCT/US10/41367 | 7/8/2010 | WO | 00 | 3/8/2012 |
Number | Date | Country | |
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61224236 | Jul 2009 | US |