Abstract:
The present disclosure relates to the field of embolic coil delivery. In particular, the present disclosure provides a delivery system that allows an embolic coil, retained on a delivery tube outside of the microcatheter, to be positioned within a target occlusion area of a patient prior to being controllably deployed, or retracted into the microcatheter for repositioning. The delivery system is particularly useful for minimizing embolic coil kickback.

Description:
CROSS-REFERENCE TO RELATED APPLICATIONS 
       [0001]    This application claims priority under 35 U.S.C. §119(e) to co-pending U.S. Provisional Application Ser. No. 62/138,498, filed on Mar. 26, 2015, herein incorporated by reference in its entirety. 
     
    
     FIELD OF THE INVENTION 
       [0002]    The present disclosure relates to the field of medical devices. Specifically, the present disclosure relates to systems and methods for releasing an embolic coil from a delivery device into the vasculature of a patient. More specifically, the present disclosure relates to a detachment mechanism that allows controlled deployment of an embolic coil beyond the distal opening of the delivery device without embolic coil kickback. 
       BACKGROUND 
       [0003]    Various medical conditions require partial or complete occlusion of blood vessels or vascular malformations (e.g., an aneurysm). Embolic coils have proven popular for such applications owing to their ability to be placed at such sites using a variety of percutaneous delivery techniques. To achieve adequate embolic coil density for embolus formation, it is common for multiple embolic coils to be implanted within the vascular malformation. Embolic coils are typically delivered to a selected site within the vasculature using a catheter-based delivery system in a minimally invasive procedure. A common delivery system design includes an embolic coil secured by a tether in the form of a simple loop that extends the length of the delivery system, passes through an attachment member on the embolic coil and extends back along the length of the delivery system. The embolic coil is reversibly retained against the distal end of the delivery system by applying tension to both free ends of the tether. The embolic coil is deployed by releasing one end of the tether while retracting the other of the tether until the free end is completely removed from the attachment member. A common problem associated with this simple loop design is that pulling the free end of the tether through the attachment member tends to cause a portion of the recently released embolic coil to protrude out of the occlusion site into the parent vessel. This partial displacement of the embolic coil, often referred to as kickback, can disrupt the flow of blood in the parent vessel and potentially lead to thrombosis in an undesired location. 
         [0004]    Accordingly, there is a continued need for a 100% detachable delivery system that allows the embolic coil to be advanced completely outside the distal end of the delivery system without deploying, and provides complete release of the embolic coil at the desired time. 
       SUMMARY 
       [0005]    Particular embodiments of the disclosure are described in the Summary and Detailed Description of the Preferred Embodiments, below. Although the disclosure has been described in connection with specific embodiments, it should be understood that the disclosure as claimed should not be unduly limited to such specific embodiments. For example, the systems and methods described herein provide controlled embolic coil deployment beyond the distal opening of the microcatheter without embolic coil kickback. 
         [0006]    In one aspect, the present disclosure relates to an embolic coil delivery system, comprising: a microcatheter that includes a proximal end defining a proximal aperture, a distal end defining a distal aperture and a lumen extending therebetween; a delivery tube slidably disposed within the lumen of the microcatheter, wherein the delivery tube includes a proximal end defining a proximal aperture, a distal end defining a distal aperture and a lumen extending therebetween; an embolic coil that includes a proximal attachment member configured to reversibly engage the distal end of the delivery tube; and a tether comprising a first end and a second end, wherein the tether forms a loop along the length of the delivery tube lumen, and wherein a portion of the tether forms a releasable knot around the proximal attachment member of the embolic coil. The first and second ends of the tether may extend outside the proximal end of the microcatheter. The lumen of the microcatheter may define an inner diameter of about 0.021 inches (0.533 mm) to about 0.027 inches (0.690 mm). The delivery tube may include an outer diameter of at most about 0.019 inches (0.483 mm). The lumen of the delivery tube may define an inner diameter of about 0.017 inches (0.432 mm). The attachment member may include an outer diameter that is substantially equal to the outer diameter of the delivery tube. For example, the attachment member may include an outer diameter of about 0.017 inches (0.432 mm). The tether may include an outer diameter of about 0.003 inches (0.080 mm). The releasable knot may be a slip-knot. For example, the releasable knot may be a highwayman&#39;s knot. Applying tension to the first end of the tether may tighten the releasable knot around the proximal attachment member of the embolic coil. Applying tension to the first end of the tether may secure the proximal attachment member of the embolic coil to the distal end of the delivery tube. Applying tension to the second end of the tether may release the releasable knot from the proximal attachment member of the embolic coil. A portion of the proximal attachment member may extend into the distal aperture of the delivery tube when the proximal attachment member is secured to the distal end of the delivery tube. The releasable knot does not extend outside the distal end of the delivery tube when the releasable knot is attached to the proximal attachment member of the embolic coil. The attachment member may comprise an eyelet defining an opening. The releasable knot may pass through the opening of the eyelet. At least a portion of the eyelet may be curved. The inner and/or outer surfaces of the eyelet may be substantially smooth. The attachment member may be formed from a proximal winding of the embolic coil. The attachment member may be fixedly attached to the proximal end of the embolic coil by a weld, solder or glue. The tether may be a flexible line, a filament, a monofilament, a multifilament, a braid, a stretch-resistant member, a suture material or a metallic wire. The metallic wire may be formed from nitinol. The first and second ends of the tether may be operatively joined to an actuator. The actuator may comprise a handle and a thumbwheel. The embolic coil may be a fibered embolic coil. The embolic coil may be comprised of a metal such as platinum, rhodium, palladium, rhenium, tungsten, gold, silver, tantalum, and alloys of these metals including platinum/tungsten alloys and nickel-titanium alloys. 
         [0007]    In another aspect, the present disclosure relates to a method of delivering an embolic coil, comprising: advancing an embolic coil delivery system to a target occlusion area within a patient; advancing delivery tube through the lumen of the microcatheter such that the distal end of the delivery tube extends outside the distal aperture of the microcatheter; and applying tension to the second end of the tether to release the proximal attachment member from the distal aperture of the delivery tube, thereby releasing the embolic coil into the target occlusion area. The delivery system may comprise a microcatheter that includes a proximal end defining a proximal aperture, a distal end defining a distal aperture and a lumen extending therebetween. A delivery tube may be slidably disposed within the lumen of the microcatheter, wherein the delivery tube includes a proximal end defining a proximal aperture, a distal end defining a distal aperture and a lumen extending therebetween. An embolic coil that includes a proximal attachment member may be configured to reversibly engage the distal end of the delivery tube. A tether comprising a first end and a second end that forms a loop along the length of the delivery tube lumen, may form a releasable knot around the proximal attachment member of the embolic coil. Applying tension to the first end of the tether may secure the proximal attachment member of the embolic coil to the distal aperture of the delivery tube. The method may further include retracting the delivery tube through the lumen of the microcatheter such that the distal end of the delivery tube does not extend outside the distal aperture of the microcatheter. The method may further include removing the delivery system from the patient. The method may still further include, prior to releasing the embolic coil, advancing or retracting the delivery tube to position the embolic coil within the target occlusion area. The method may still further include removing the delivery tube from the lumen of the microcatheter. A second embolic coil may be loaded into the delivery tube. The delivery tube loaded with the second embolic coil may be advanced through the lumen of the microcatheter to a target occlusion area. The second embolic coil may be released the embolic coil into the target occlusion area. 
         [0008]    In yet another aspect, the present disclosure relates to a kit for delivery of an embolic coil, comprising: a microcatheter defining a lumen disposed along an axis, the microcatheter having a proximal end defining a proximal aperture, a distal end defining a distal aperture, an inner diameter and an outer diameter; a delivery tube defining a lumen disposed along an axis, the delivery tube having a proximal end defining a proximal aperture, a distal end defining a distal aperture, an inner diameter and an outer diameter, wherein the outer diameter of the delivery tube is less than the inner diameter of the microcatheter; an embolic coil that includes a proximal attachment member configured to reversibly engage the distal aperture of the delivery tube; and a tether comprising a first end and a second end, wherein the tether is disposed along the length of the delivery tube lumen and coupled to the proximal attachment member of the embolic coil by a releasable knot. 
     
    
     
         [0009]    Non-limiting embodiments of the present disclosure are described by way of example with reference to the accompanying figures, which are schematic and not intended to be drawn to scale. In the figures, each identical or nearly identical component illustrated is typically represented by a single numeral. For purposes of clarity, not every component is labeled in every figure, nor is every component of each embodiment of the disclosure shown where illustration is not necessary to allow those of ordinary skill in the art to understand the disclosure. In the figures: 
           [0010]      FIG. 1  depicts a delivery system in which the delivery tube and attached embolic coil are disposed entirely within the lumen of the microcatheter, in accordance with one embodiment of the present disclosure. 
           [0011]      FIG. 2  depicts the delivery system of  FIG. 1  after the delivery tube and attached embolic coil have advanced outside the distal end of the microcatheter, in accordance with another embodiment of the present disclosure. 
           [0012]      FIG. 3  depicts a magnified view of the delivery tube and attached embolic coil positioned outside the distal end of the microcatheter, in accordance with another embodiment of the present disclosure. 
           [0013]      FIGS. 4A-C  depict a releasable knot in the tightened ( 4 A), partially released ( 4 B) and completely released ( 4 C) configurations, in accordance with embodiments of the present disclosure. 
           [0014]      FIG. 5  depicts the delivery system of  FIG. 2  following the release of the embolic coil from the delivery tube, in accordance with yet another embodiment of the present disclosure. 
           [0015]      FIG. 6  depicts the delivery system with the delivery tube retracted into the microcatheter following the release of the embolic coil, in accordance with another embodiment of the present disclosure. 
       
    
    
       [0016]    It is noted that the drawings are intended to depict only typical or exemplary embodiments of the disclosure. It is further noted that the drawings may not be necessarily to scale. Accordingly, the drawings should not be considered as limiting the scope of the disclosure. The disclosure will now be described in greater detail with reference to the accompanying drawings. 
       DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENTS 
       [0017]    Before the present disclosure is described in further detail, it is to be understood that the disclosure is not limited to the particular embodiments described, as such may vary. It is also to be understood that the terminology used herein is for the purpose of describing particular embodiments only, and is not intended to be limiting beyond the scope of the appended claims. Unless defined otherwise, all technical terms used herein have the same meaning as commonly understood by one of ordinary skill in the art to which the disclosure belongs. Finally, although embodiments of the present disclosure are described with specific reference to systems and method for delivering embolic coils, it should be appreciated that the scope of the disclosure may be applicable to a number of implantable devices requiring delivery to specific location(s) within a patient, including for example, occlusion balloons, self-expanding stents and the like. 
         [0018]    The present disclosure is generally directed to systems and methods for actively releasing medical devices, including, for example, embolic coils within a body lumen of a patient. More specifically, the present disclosure relates to an embolic coil that is  100 % detachable and designed to allow the embolic coil to be advanced (i.e., pushed) completely outside the distal end of the delivery microcatheter without deploying. The embolic coil remains attached to the distal end of the delivery tube by an easy-release knot that provides a simple detachment mechanism that is completely controlled by the medical professional. For example, as described in greater detail below, once the delivery tube and attached embolic coil have been advanced outside the distal end of the microcatheter, the medical professional has the option of releasing the embolic coil into the patient or retracting the delivery tube and attached embolic coil back into the microcatheter for repositioning within, or removal from, the patient. 
         [0019]      FIG. 1  depicts an embolic coil delivery system, which includes a microcatheter  10  with a proximal end  14  optionally defining a proximal aperture  15 , a distal end  16  defining a distal aperture  17  and a lumen  12  extending therebetween. A delivery tube  20  is slidably disposed within the lumen  12  of the microcatheter  10 . The delivery tube  20  includes a proximal end (not indicated) optionally defining a proximal aperture (not indicated), a distal end  26  defining a distal aperture  27  and a lumen extending therebetween. An embolic coil  30  is reversibly coupled to the distal end  26  of delivery tube  20  by a proximal attachment member  32 , which in preferred embodiments defines a loop or other structure configured to accept a mechanical coupling means as described below. In preferred embodiments, mechanical coupling between the embolic coil  30  and the delivery system is achieved by means of a tether that includes first and second ends  42   a,    44   a  that form a loop along the length of the lumen of delivery tube  20 . The first and second ends  42   a,    44   a  of the tether extend outside the proximal end  14  of the microcatheter  10 . A portion  42   b  and  44   b  of the tether between the first and second ends  42   a,    44   a  is tied to the proximal attachment member  32  by a releasable knot  46 . As illustrated in  FIG. 1 , the proximal attachment member includes an opening  38  through which the releasable knot is secured. The releasable knot  46  is configured such that applying tension to (i.e., pulling) the first end  42   a  of the tether in a proximal direction relative to the microcatheter tightens the releasable knot about the proximal attachment member  32 . In addition to tightening the releasable knot, the tension applied to the first end  42   a  of the tether reversibly secures the proximal attachment member  32  against distal end  26  of the delivery tube  20 . 
         [0020]    As used herein, the term “tether” refers to a flexible line, including but not limited to, a filament, monofilament, multifilament, braid, suture material or wire (including metallic wire, such as nitinol) capable of being formed into a knot. For example, in one embodiment of the present disclosure, the tether is formed from a suture material or nitinol wire with a diameter of about 0.003 inches (0.080 mm). Similarly, the term “slipknot,” “slip-knot” or “easy-release knot,” as used herein, refers to a knot formed from a single continuous tether that includes two free ends that extend beyond the proximal end of the microcatheter. Pulling one of the free ends forces the knot to tighten around the structure to which it is attached, while pulling on the other free end will release the knot. While the releasable knot depicted herein (see  FIGS. 4A-C ) is referred to as a “Highwayman&#39;s knot,” it should be appreciated that the present disclosure is in no way limited to this specific type of knot, but can include any number of slipknots known in the art, including, for example, a mooring hitch knot, a slipped buntline knot, a tumble hitch knot and the like. 
         [0021]    As illustrated in  FIG. 2 , the delivery tube  20  may be advanced (i.e., pushed) distally through the lumen  12  of the microcatheter  10  until the distal end  26  of delivery tube  20  and embolic coil  30  are disposed outside of distal end  16  of the microcatheter  10 . Importantly, the proximal tension on first end  42   a  of the tether is maintained while the delivery tube is being advanced distally such that the proximal attachment member  32  of embolic coil  30  remains securely coupled to the distal end  26  of delivery tube  20 . 
         [0022]    As best illustrated in  FIG. 3 , the delivery tube  20 , proximal attachment member  32  and embolic coil  30  are dimensioned to fit within the lumen  12  of the microcatheter  10 . However, the proximal attachment member  32  is dimensioned to only partially fit within the distal aperture of  27  of the delivery tube  20 . By way of non-limiting example, in one embodiment the distal aperture  17  of microcatheter  10  has an inner diameter  18  of about 0.021 inches (0.533 mm) to about 0.027 inches (0.690 mm). The delivery tube  20  has a corresponding outer diameter  29  that is slightly smaller, e.g., about 0.019 inches (0.483 mm) than the inner diameter  18  of the microcatheter to permit the delivery tube  20  to slide within the lumen  12  of the microcatheter  10 . The distal end  26  of delivery tube  20  further defines a distal aperture  27  with an inner diameter  28  of about 0.017 inches (0.432 mm). Importantly, the proximal attachment member  32  includes a corresponding outer diameter  34  that is approximately equal to the outer diameter  29  of the delivery tube, e.g., about 0.019 inches (0.483 mm). 
         [0023]    Providing a proximal attachment member  32  with an outer diameter  34  that is approximately equal to the outer diameter  29  of the delivery tube ensures that the proximal attachment member  32  and embolic coil  30  are able to pass through the lumen  12  of microcatheter  10 , but cannot fully enter the lumen of delivery tube  20 . This configuration ensures that embolic coil  30  remains reversibly secured to the distal end  26  of the delivery tube  20  until the releasable knot is untied. Of course, all of the dimensions provided above should be viewed only as guidelines, and the disclosure, in its broader aspects, should not be limited thereto. 
         [0024]    One advantage associated with retaining the embolic coil  30  outside of the delivery tube  20  is that it allows the thickness of the delivery tube to be increased, thereby imparting greater strength and control (i.e., pushability) for advancing the delivery tube throughout the entire length of the microcatheter. 
         [0025]    Another advantage associated with the proximal attachment member  32  described herein is that it includes a portion proximal to the outer diameter  34  that extends partially into the distal aperture  27 . This allows the releasable knot  46  to reversibly engage the proximal attachment member entirely within the delivery tube  20 . This eliminates safety concerns associated with the releasable knot  46  being exposed to the lining of the vasculature wall and/or microcatheter  10  during deployment of the embolic coil  30 . For example, preventing exposure of the releasable knot  46  to the environment outside of the delivery tube limits the likelihood of thrombus formation that could affect the deployment and/or retraction of the embolic coil  30 . Preventing exposure of the releasable knot  46  to the microcatheter lumen  12  also limits potential problems with deploying and/or retracting the embolic coil, and minimizes wear (i.e., abrasion) on the tether itself. 
         [0026]    Yet another advantage associated with the proximal attachment member  32  described herein is that its curved designs also allows the embolic coil to be re-centered within the distal aperture  27  of the delivery tube  20  if repositioning and/or removal is required (discussed below). 
         [0027]    While the proximal attachment member may include a variety of shapes, in one embodiment the proximal attachment member  32  is a curved eyelet, similar to that of a sewing needle. The eyelet may be made of a variety of materials, including the same materials used to form the embolic coil (discussed below). In one embodiment, the eyelet is formed from a proximal winding of the embolic coil. In another embodiment, the eyelet is formed separately from the embolic coil, and attached to the embolic coil by a solder, weld, glue or related bonding techniques known in the art. An eyelet, or similar design, as depicted herein is preferable due to its small size and absence of sharp edges. For example, the smooth surfaces of the eyelet will not cut the tether and/or the vasculature of the patient. Similarly, the small size of the eyelet allows it to remain inside the vascular malformation without extending into the parent vessel. 
         [0028]      FIG. 4  depicts a magnified view of a releasable knot according to one embodiment of the present disclosure.  FIG. 4A  specifically depicts a Highwayman&#39;s knot secured to a curved portion of the proximal attachment member  32 . The knot remains secured to the proximal attachment member by applying continuous tension to the first end  42   a  of the tether. As discussed above, pulling first end  42   a  in a proximal direction relative to the microcatheter  10  also ensures that the eyelet remains coupled to the distal end  26  of delivery tube  20 . Importantly, little or substantially no tension is applied to second end  44   a  of the tether when in the tightened configuration. As best depicted in  FIG. 4B , the process of releasing the Highwayman&#39;s knot from the proximal attachment member  32  begins applying tension to the second end  44   a  of the tether, while simultaneously relieving at least some of the tension applied to first end  42   a.  While at least partially relieving some of the tension applied to first end  42   a  allows the second end  44   a  of the tether to more easily unwrap from the eyelet, it should be appreciated that the knot may be released while first end  42   a  remains under tension. As shown in  FIG. 4C , continued application of tension to the second end  44 a of the tether eventually unties the releasable knot such that no portion of the tether is in contact with the proximal attachment member  32 . 
         [0029]    As best depicted in  FIG. 5 , once the medical professional has verified that the embolic coil  30  is properly positioned within the patient, the embolic coil  30  may be released by untying the knot as discussed in  FIGS. 4A-C . In one embodiment, the first and second ends  42   a,    44   a  of the tether extend outside the proximal end  14  of the microcatheter  10  and are secured within an actuator (not shown) that includes a handle and thumbwheel. Such actuators are known in the art, including, for example, U.S. Pat. Nos. 8,784,446, 7,285,117, and 6,102,920 herein incorporated by reference in their entirety. The thumbwheel allows the medical professional to control the amount of tension applied to the first or second ends  42   a,    44   a  of the tether as necessary. For example, when the delivery system is being advanced through the vasculature of the patient the thumbwheel may allow the medical professional to maintain the desired amount of tension on the first end  42   a  of the tether to maintain the proximal attachment member  32  securely coupled to the distal end  26  of the delivery tube  20 . Once the embolic coil  30  is properly positioned within the patient, the medical professional can use the thumbwheel to release the tension on the first end  42   a  of the tether and apply tension on the second end  44   a  until the knot  46  releases from the eyelet. 
         [0030]    Again, the immediate release affected by this knot configuration allows the embolic coil to be 100% detachable since no portion of the tether remains in contact with the proximal attachment member  32  once the knot is untied. The releasable knot  46  is therefore superior to simple loop designs that require the free end of the tether to be pulled all the way through the embolic coil attachment mechanism. As discussed above, the process of removing the tether tends to cause displacement/kickback of the deployed embolic coil into the parent vasculature. 
         [0031]    Referring to  FIG. 6 , once the embolic coil is released from the distal end  26  of the delivery tube  20 , the delivery tube is retracted into the lumen  12  of the microcatheter  10 . The entire delivery system may then be removed from the patient. Alternatively, the delivery tube  20  may be withdrawn from the lumen  12  of the microcatheter  10 , and the microcatheter  10  re-loaded with another delivery tube  20  containing an embolic coil  30 . Once the ends  42   a  and  44   a  are secured to the actuator, the delivery tube  20  and attached embolic coil  30  may be advanced through the lumen  12  and distal aperture  17  of the microcatheter  10 . Upon verifying that the second embolic coil  30  is properly positioned within the patient, the embolic coil can be released and/or repositioned according the steps described above. This procedure may be repeated as necessary based on the size and shape of the particular vascular malformation. 
         [0032]    Referring back to  FIGS. 2 and 3 , it should be emphasized that if the medical professional determines that the embolic coil  30  is improperly positioned once the delivery tube  20  has been advanced outside of the distal aperture  17  of microcatheter  10 , the delivery tube and microcatheter may be retracted into the lumen  12  of the microcatheter for repositioning or removal from the patient. 
         [0033]    The embolic coil  30  may be formed from a plurality of coil windings. When manufacturing the embolic coil  30 , the coil material is wound into a coil shape, which will typically be linear. Generally speaking, the embolic coil  30  is a metallic coil formed from metals or alloys, for example, selected from platinum group metals, particularly platinum, rhodium, palladium, and rhenium, as well as tungsten, gold, silver, tantalum, and alloys of these metals including platinum/tungsten alloys and nickel-titanium alloys (nitinol) among others. These materials have significant radiopacity, and their alloys may be tailored to have a blend of flexibility and stiffness for the coil. They are also generally biologically inert. The diameter of the wire used in the production of the embolic coil  30  may fall in the range of 0.00025 inches (0.00635 mm) to about 0.006 inches (0.152 mm). The embolic coil  30  may have a primary diameter of between about 0.003 (0.080 mm) and about 0.025 inches (0.635 mm), but for most applications a diameter between about 0.008 inches (0.203 mm) to about 0.018 inches (0.457 mm) provides sufficient hoop strength to hold the embolic coil  30  in place within the chosen body site, lumen or cavity without substantially distending the wall of the site and without moving from the site as a result of the repetitive fluid pulsing found in the vascular system. In one embodiment, the embolic coil is a fibered embolic coil. 
         [0034]    All of the devices and/or methods disclosed and claimed herein can be made and executed without undue experimentation in light of the present disclosure. While the devices and methods of this disclosure have been described in terms of preferred embodiments, it will be apparent to those of skill in the art that variations can be applied to the devices and/or methods and in the steps or in the sequence of steps of the method described herein without departing from the concept, spirit and scope of the disclosure. All such similar substitutes and modifications apparent to those skilled in the art are deemed to be within the spirit, scope and concept of the disclosure as defined by the appended claims.