Abstract:
An occluding device apparatus includes an embolization coil with a distal end and a proximal end with an opening and an attacher that is threaded through the opening at the proximal end of the embolization coil. The apparatus further comprises a delivery kit for delivery of the embolization coil in a body cavity. The kit comprises a guide catheter for percutaneous introduction of the embolization coil and an inner catheter slidably disposed within the guide catheter during insertion. The inner catheter comprises a proximal end and a distal end. The inner catheter further includes a hub disposed adjacent the proximal end. The kit further comprises a guide wire slidably disposed within the inner catheter. The guide wire provides a path during insertion thereof within a body cavity. The kit further comprises a pushwire to advance the embolization coil through the inner catheter.

Description:
BACKGROUND 
       [0001]    The embodiments of the present invention relate to medical devices. More particularly, the embodiments relate to assemblies for deploying medical devices including occluding devices into a body cavity. 
         [0002]    Medical devices such as embolization coils and plugs have been used as a primary occluding device for treatment of various arteriovenous malformations (AVM) and varicoceles, as well as for many other arteriovenous abnormalities in the body. Occluding devices are also used to repair abnormal shunts between arteries and veins, prevent or reduce blood flow to tumors, stop hemorrhaging as a result of trauma, and stabilize aneurysms to prevent rupture. Embolization coils, for example pushable fibered coils, may be made in a variety of sizes with varying diameters and may be made of several different materials including stainless steel and platinum. Occlusion devices may vary for differing purposes, e.g., to hold the device in place within a cavity or vessel and to pack the device within the vessel for enhanced occlusion. 
         [0003]    Although current devices are adequate, in some cases delivery of such coils or plugs may be improved for more effective occlusion of fluid flow through a lumen of a body vessel. Many medical procedures for occluding blood flow through an artery or vein require a number of coils, since a single coil or two may not be sufficient to effectively occlude blood flow through a lumen of an artery or vein. In some cases, delivery of such a coil or a plug can involve pushing a coil through the lumen of a delivery catheter using a pusher element. In other cases, the device, such as the coil or plug, can be receive a threaded end of a delivery device, and the practitioner deploying the device can use rotational force to separate the device from the delivery mechanism. 
         [0004]    In certain cases, delivery can be complicated because without some sort of external surface pushing back against the rotation, the device may simply rotate with the delivery member rather than becoming disengaged from it. In many cases, the external friction is derived from contact with the wall of the vessel in which the device is being deployed. This can be disadvantageous when the body cavity to which the device is being deployed is particularly delicate, such as in an aneurysm. 
       BRIEF SUMMARY OF THE INVENTION 
       [0005]    There is a need for an improved means of delivery of medical devices such as coils and plugs into body cavities. The medical device described herein provides an assembly for and a method of delivering a device into the lumen of a body vessel. 
         [0006]    In one aspect, the present invention is a medical device delivery assembly comprising a medical device to be deployed having a first proximal end and a first distal end. The first proximal end has a first interior lumen and a first outer surface with at least one prong being attached to the first outer surface of the first proximal end. The assembly has a delivery portion having a second proximal end and a second distal end. The delivery portion having a second interior lumen and a second outer surface, the second interior lumen being sized so as to fit the first proximal end of the medical device to be deployed therein. The second distal end of the delivery portion has at least one notch which receives the at least one prong of the medical device to be deployed. The assembly further comprises a mandrel having a third proximal end and a third distal end and slidably disposed within the interior lumen of the second interior lumen of the delivery portion, the third distal end of the mandrel fitting within the first interior lumen of the first proximal end of the medical device to be deployed. In another form, the occluding device includes an embolization coil with a distal end and a proximal end and a suture or an attacher that is tied as a slip-knot around the proximal end of the embolization coil. 
         [0007]    In another aspect, the present invention is a method of deploying a medical device in a body cavity. The method provides a medical device having a first proximal end and a first distal end, the first proximal end having a first interior lumen and a first outer surface, at least one prong being attached to the first outer surface of the first proximal end. The method provides a delivery portion having a second proximal end and a second distal end, the delivery portion having a second interior lumen and a second outer surface. The second interior lumen is sized so as to fit the first proximal end of the medical device to be deployed therein. The second distal end of the delivery portion has at least one notch which can receive the at least one prong of the medical device to be deployed. The method then comprises threading a mandrel having a third proximal end and a third distal end, the third distal end being threaded, into the first interior lumen of the first proximal end of the medical device to be deployed. The mandrel is inserted into the second interior lumen of the delivery portion. The medical device and the delivery portion are then introduced into a patient percutaneously, and the device is maneuvered to the location where the device is to be delivered. The mandrel is then rotated until the third distal end of the mandrel is no longer within the first interior lumen of the medical device, and the medical device is released into the body cavity. 
         [0008]    In a third aspect, the present invention is a kit for deploying a medical device to a body cavity. In this embodiment, the kit comprises a medical device to be deployed having a first proximal end and a first distal end, the first proximal end having a first interior lumen and a first outer surface and at least one prong being attached to the first outer surface of the first proximal end. The kit provides a sheath for positioning the medical device in the body cavity comprising a delivery portion having a second proximal end and a second distal end, the delivery portion having a second interior lumen and a second outer surface. The second interior lumen is sized so as to fit the first proximal end of the medical device to be deployed therein. The second distal end of the delivery portion has at least one notch which can receive the at least one prong of the medical device to be deployed. The kit also provides a mandrel having a third proximal end and a third distal end and slidably disposed within the interior lumen of the second interior lumen of the delivery portion, the third distal end of the mandrel which can fit within the first interior lumen of the first proximal end of the medical device to be deployed. 
         [0009]    Further features and advantages will become apparent from the following description and from the claims. 
     
    
     
       BRIEF DESCRIPTION OF THE DRAWINGS 
         [0010]      FIG. 1  is a perspective view of a medical device partially engaged with a delivery assembly in accordance with one embodiment of the present; 
           [0011]      FIG. 2A  is a perspective view of the medical device fully engaged with the delivery assembly; 
           [0012]      FIG. 2B  is a cutaway perspective view of the medical device fully engaged with the delivery assembly; 
           [0013]      FIG. 3  is a partial side view of a mandrel of the delivery assembly; 
           [0014]      FIG. 4  is a perspective view of the medical device disengaged from the delivery assembly; 
           [0015]      FIG. 5A-C  are perspective views of medical devices and delivery assemblies; 
           [0016]      FIG. 6A  is an exploded view of an embolization kit; and 
           [0017]      FIG. 6B  is a side view of the embolization kit of  FIG. 6A . 
       
    
    
     DETAILED DESCRIPTION OF THE INVENTION 
       [0018]    This description is not intended to limit the present invention in any manner, but rather serves to enable those skilled in the art to make and use the invention. 
         [0019]    The terms “substantially” or “about” used herein with reference to a quantity or shape includes variations in the recited quantity or shape that are equivalent to the quantity or shape recited, such as an amount or physical conformation that is equivalent to the quantity or shape recited for an intended purpose or function. 
         [0020]    A medical device may be deployed to a body cavity and employed for treatment of a number of conditions in which partial or complete occlusion of a body cavity is desired, including but not limited to renal arteriovenous malfunction (AVM), pulmonary AVM, vascular tumors, low-flow fistulas, trauma related hemorrhages, and visceral vasculature defects including varicoceles, aneurysms, and selected telangiectasias. For example, treatment of visceral vasculature defects may include but are not limited to embolotherapy on gastroduogenal hemorrhages, hepatic aneurysms, celiac aneurysms, internal iliac aneurysms, and internal spermatic varicoceles. 
         [0021]    Although occluding devices are explicitly named in the proceeding, it is another intended aspect of this invention to provide a delivery assembly that allows for reliable and convenient detachment of any medical device. In this aspect, the medical device which is intended to remain in the lumen of a body cavity or vessel as a permanent or temporary method of treatment. 
         [0022]      FIG. 1  shows a medical device  10  and medical device delivery assembly in accordance with one embodiment of the present invention. As shown, the device  10  is positioned extending out of interior lumen  24  of delivery catheter  20 . 
         [0023]    As illustrated in  FIG. 1 , device  10  is an occluding coil comprising a first proximal portion  16  and a first distal portion  12 . In one aspect, the medical device (in this case, a coil) extends from the first proximal end  16  to the first distal end  12 . The device  10  is illustrated in truncated form for clarity and the illustration is not intended to limit the length of the coil in the distal direction, nor does it limit the type of device that can be employed to a coil. Device  10  also includes a pair of rail structures  14  toward its proximal end. The rail structures  14 , alternately termed rails  14 , are illustrated as rectangular blocks for simplicity but may be of other shapes such as rounded shapes, elliptical shapes, triangular shapes, or any other shapes which may reasonably fitted into a corresponding receiving element. 
         [0024]    The rails  14  can be made of any suitable material, including metal or rigid polymer, and can either be prefabricated as a component of the device  10  or can be separately formed and attached after manufacture. There can be a single rail, or a plurality of rails  14 . The rails can vary in shape, in length, and in width. The rails  14  can be evenly spaced around the perimeter of the first proximal portion  16  of the medical device  10  or the rails  14  can be biased to one portion of the device. Although the rails  14  of  FIG. 1  are illustrated as being the same size and shape as one another, it is not necessary that they are. For instance, one rail  14  of a device  10  can be substantially rectangular while a second rail  14  is substantially circular. 
         [0025]    The rails  14  can be fixed at any point axially along the length of the device  10 . In cases of devices  10  with a relatively short length, the rails may be extend the entire length of the device. In other devices, the rails  14  may be set at a point substantially closer to the proximal end than to the distal end of the device  10 . In this case, the effect will be that the device  10  will be both disengaged from the locking assembly comprising the rails and notches, but a portion of the device  10  will remain within the delivery catheter. Various embodiments reflecting the fact that the rails  14  can be placed at different positions along the axial length of device  10  are depicted in the drawings. However, the rails  14  will be fixed at approximately the same axial position on the device such that when the device is rotably disengaged from the mandrel, the whole device is free to move independent of the delivery assembly. 
         [0026]    The delivery catheter  20  of  FIG. 1  is further subdivided into two portions: a second proximal portion  26  and a second distal portion  28 . In one aspect, the second proximal portion  26  extends to the second distal portion  28 . As illustrated, the second proximal portion can comprise a braid  22 . If a braided catheter is used, it may be made of materials including but not limited to high tensile stainless steel, such as 304V stainless steel wire, tungsten, gold, titanium, silver, copper, platinum, palladium, iridium, nickel-cobalt alloys, cobalt chrome alloys, molybdenum tungsten alloys, tantalum alloys, and titanium alloys. Some metals, such as tungsten and tungsten alloys, may be preferred to permit improved visualization of the assembly. 
         [0027]    Other tubular catheter assemblies which are not braided are acceptable for use in this assembly. The catheter can be made of any suitable material, including a shape memory polymer or another plastic. The catheter has an interior lumen  24  which is wide enough to fit mandrel  40  within. 
         [0028]    Second distal portion  28  of the delivery catheter comprises outer tube  30 . Outer tube  30  has at its distal end at least one notch  32 . The notches  32  are equal in number to the rails  14  of the device  10  which is to be deployed, and their size and shape are such that they are capable of receiving and securely engaging the rails  14 . The outer tube  30  has a number of notches  32  to receive the rails  14  in sufficient quantity so that all notches are accommodated. For instance, as illustrated in  FIG. 1 , the rectangular rails  14  are of a size and shape that they will fit into notches  32 . 
         [0029]    Outer tube  30  may be attached to the second proximal portion of the delivery catheter in any suitable way. The outer tube  30  may be soldered or welded onto the distal end of the second proximal portion  26 , or the distal end of the second proximal portion may be crimped to a size where it can be snugly placed within an interior lumen of outer tube  30 . The outer tube  30  can be made of rigid or flexible material, of metal, polymer, or plastic, as long as it is able to receive and securely engage the rails  14 . 
         [0030]    In an alternative embodiment, the at least one notch  32  can be formed from the distal end of a delivery catheter during or after its manufacture instead of attaching a separate outer tube  30  to the distal end of the delivery catheter. 
         [0031]    As illustrated in  FIG. 2A , first proximal portion  16  of the medical device  10  is sized to fit into the interior lumen of outer tube  30 . As in  FIG. 1 , the portion of the medical device distal to the portion illustrated is not shown for purposes of clarity. 
         [0032]      FIG. 2A and 2B  represent an initial delivery configuration for the delivery assembly. The medical device  10  would be engaged with mandrel  40  via threads  42  and packed for delivery with the at least one rails  14  seated in at least one notches  32 . A device in this configuration would be longitudinally locked; that is, the engagement of the device  10  with the threads  42  of mandrel  40  would prevent motion along the longitudinal axis of the delivery catheter  20 , preventing accidental slippage of the device off of the end of the mandrel  40  and into an undesired position within the body cavity prior to intended deployment. Pushing the mandrel alone, without rotational force, will not dislodge the coil into the lumen of the body cavity or vessel. 
         [0033]    In one embodiment, the first proximal portion  16  of the medical device  10  which can be housed within the interior of the outer tube  30  is relatively short in length, for instance no longer than about 3 millimeters. Because the delivery assembly may need to maneuver through relatively tortuous portions of the vasculature or other parts of the anatomy, the relatively stiff outer tube  30  should be kept to a smaller length. 
         [0034]    As shown in  FIG. 3 , the mandrel  40  is another component of the medical device delivery system. The mandrel comprises a third distal end  48  which has threads  42  and extends to a third proximal end  46 , which the physician uses to rotate and thereby move the device  10  from its engaged to disengaged state. The mandrel is made of a flexible material, such as a shape memory metal or a flexible polymer, as shown by bend  44 . The mandrel is made of a flexible material in order to facilitate negotiation of tortuous portions of the anatomy. 
         [0035]      FIG. 4  illustrates another embodiment of the invention of this disclosure. In this case, the interventionalist has rotated the mandrel  40  and the device  10  has been disengaged from threads  42  of the mandrel  40 . Note that rails  14  of the device continue to be associated with the device. Although the embodiment illustrated in  FIG.1 ,  2 A,  2 B, and  4  shows rails  14  as a component of the device to be delivered, it is also envisioned that an inverted configuration wherein the rails  14  comprise a portion of delivery catheter  20  and the notches  32  are instead on the proximal end of device  10 . 
         [0036]    As mentioned, the process of preparation of a device for deployment begins with seating the prongs or rails  14  within the notches  32 . Then the third distal end of a mandrel, which is threaded, is threaded into the interior of the medical device  10  with the mandrel also passing into the second interior lumen of the delivery portion. 
         [0037]    In the interventional suite, the medical device and the delivery portion are introduced into a patient percutaneously and the device is maneuvered to the location (that is, the body cavity or the body vessel where the device is to be delivered) buy using a pushing force. When the desired location has been reached the mandrel is rotated by the interventionalist at its third proximal end until the third distal end of the mandrel is no longer within the first interior lumen of the medical device, thereby releasing the medical device into the body cavity. 
         [0038]    One advantage of such a method is that the delivery assembly does not need to gain purchase on the vessel wall during delivery and deployment in order to create a mechanical force that allows for rotation of the mandrel without concomitant rotation of the device. Such force is instead generated from contacting the rails  14  with the outer tube  30  within notches  32 , keeping the device itself stationary as the mandrel alone rotates and becomes disengaged from the device. When the mandrel is freed from the first proximal end  16  of the device  10 , the device  10  is no longer kept in place and can thus move in longitudinally in the distal direction in order to be deployed to the body cavity or vessel. When the threads  42  of the mandrel  40  are disengaged from the device  10 , the device  10  is effectively considered to be in the deployed state. 
         [0039]      FIG. 5A-5C  illustrate alternative embodiments of the medical device delivery assembly. In each case, alternative configurations of rails  114 / 214 / 314  are shown with their respective notches  132 / 232 / 332 . In  FIG. 5A , the rails  114  and notches  132  are substantially triangular. In  FIG. 5B , the rails  214  are relatively small circular-shaped points which are able to slide into notches  232 . Note that although the lengthwise size of the rails is shortened, the notches themselves are still of approximately the same lengths in other embodiments. Finally, in  FIG. 5C  a single-rail, single-notch device is shown. In this embodiment, notch  332  is not parallel to the longitudinal axis, and rail  314  is likewise at an angle. Still, when rotational force is applied to the mandrel, the rail will be gradually expelled from the notch  332  and will altogether disengage. 
         [0040]    The components of the invention of this disclosure, including the rails, the notches, and the outer tube of the delivery catheter, can be made as portions of entirely new devices or can exist as modifications to well-known devices. One particular device which would benefit from improvements as listed above is the microcoil. These coils are small and must occasionally be deployed into difficult-to-access portions of the anatomy. As such, the extra precision gained from using a screw-type delivery assembly would be a benefit in delivering these devices. 
         [0041]    As mentioned, the device  10  may preferably be an embolic coil. Such a coil may be made of primary and secondary coils which are fabricated from shape memory materials or alloys, such as superelastic nickel-titanium alloys. In one embodiment, the diameter of the coil is smaller toward the proximal end  16  in order to keep the width consistent as this is where the rails  14  will be attached. Alternatively, the coil may substantially comprise simply a primary coil. An example of a suitable superelastic nickel-titanium alloy is Nitinol, which can “remember” and recover a previous shape. 
         [0042]    Nitinol undergoes a reversible phase transformation between a martensitic phase and an austenitic phase that allows it to “remember” and return to a previous shape or configuration. For example, compressive strain imparted to the coils  18 ,  28  in the martensitic phase to achieve a low-profile delivery configuration may be substantially recovered during a reverse phase transformation to austenite, such that the coils  18 , expand to a “remembered” (e.g., deployed) configuration at a treatment site in a vessel. Typically, recoverable strains of about 8-10% may be obtained from superelastic nickel-titanium alloys. The forward and reverse phase transformations may be driven by a change in stress (superelastic effect) and/or temperature (shape memory effect). 
         [0043]    Slightly nickel-rich Nitinol alloys including, for example, about 51% Ni and about 49% Ti are known to be useful for medical devices which are superelastic at body temperature. In particular, alloys including 50.6-50.8% Ni and 49.2-49.4% Ti are considered to be medical grade Nitinol alloys and are suitable for the present coils  18 ,  28 . The nickel-titanium alloy may include one or more additional alloying elements. 
         [0044]    Turning now to  FIGS. 6A and 6B , there is illustrated the embolization kit  310  which implements the occluding device  10 . As shown, the kit  310  includes an inner catheter  314  preferably made from a soft, flexible material such as silicone or any other suitable material. Generally, the inner catheter  315  has a proximal end  316 , a distal end  318 , and an outer tube as an adapter or hub  320  to receive apparatus to be advanced therethrough. The kit  310  further includes a guide wire  322  which provides a path during insertion of the catheter  324  within a body cavity. The size of the wire guide is based on the inside diameter of the guide catheter  324 . 
         [0045]    In one embodiment, the kit  310  further includes a polytetrafluoroethylene (PTFE) guide catheter or sheath  324  for percutaneously introducing the inner catheter  315  in a body vessel. Of course, any other suitable material may be used. The guide catheter  324  may have a size of about 4-French to  8 -French and allows the inner catheter  315  to be inserted therethrough to a desired location in the body cavity. The guide catheter  324  receives the inner catheter  315  and provides stability of the inner catheter  315  at a desired location of the body cavity. For example, the guide catheter  324  may stay stationary within a common visceral artery, e.g., a common hepatic artery, and add stability to the inner catheter  315  as the inner catheter is advanced through the guide catheter to a point of occlusion in a connecting artery, e.g., the left or right hepatic artery. 
         [0046]    The medical device  10  has been loaded at distal end  318  of the inner catheter  315 . The prongs or rails of the device  10  are interlocked within the notches  337  of the outer tube  333  which is attached to distal end  318  of the inner catheter  315 . In this embodiment, a mandrel is used to mechanically advance or push the occluding device  10  through the inner catheter  314  before application of rotational force and deployment of the device. The size of the push wire used depends on the diameters of the inner catheter  315 . 
         [0047]    It is to be understood that the embolization kit  310  described above is merely one example of a kit that may be used to deploy the medical device in a body cavity or vessel. Other kits, assemblies, and systems may be used to deploy any embodiment of the occluding device without falling beyond the scope or spirit of the present. 
         [0048]    The aforementioned as well as other embodiments are within the following claims.