Abstract:
A magnet assembly for a magnetic anastamosis device is provide that is minimally invasive, easily and quickly delivered, and is accurately positioned to improve the delivery procedure. The magnet assembly includes an elongated hub and a plurality of magnetic members disposed over the elongated hub. The elongated hub is formed of a resilient or shape memory material, permitting the magnet assembly to be operable between a delivery configuration and a deployed configuration. In this manner, the package width of the magnet assembly is greatly reduced for delivery, thereby permitting delivery over a wire guide as well as through an access device such as a catheter. Associated delivery procedures and medical devices are also provided.

Description:
CROSS-REFERENCE TO RELATED APPLICATIONS 
     This application claims the benefit of U.S. Provisional Application Ser. No. 60/978,754, filed on Oct. 9, 2007, entitled “MAGNETIC ANASTOMOSIS DEVICE HAVING IMPROVED DELIVERY” 
    
    
     FIELD OF THE INVENTION 
     The present invention relates generally to magnetic anastomosis devices for forming an anastomosis between two viscera. 
     BACKGROUND OF THE INVENTION 
     Magnetic anastomosis devices (MADs) are currently used to create a channel between two viscera for the purpose of redirecting bodily fluids. For example, intestinal contents or bile may be redirected in patients who have developed an obstruction of the bowel or bile duct due to such conditions as tumor, ulcer, inflammatory strictures or trauma. With reference to  FIG. 1 , the relative positions of several organs of the abdominal cavity are shown, including the gall bladder  10 , the common bile duct  12 , the stomach  14 , the duodenum  16  and the jejunum  18  of the small intestine. Inflammatory strictures  20 ,  22  of the jejunum  18  and bowel duct  12  are shown by the dotted lines in  FIG. 1 . 
     A magnetic anastomosis device (MAD)  30  has been depicted in  FIG. 2 , the details of which may be found in U.S. Pat. No. 5,690,656, the disclosure of which is incorporated herein by reference in its entirety. Generally, the MAD  30  includes first and second magnet assemblies  30   a ,  30   b  comprising magnetic cores  36   a ,  36   b  which are surrounded by thin metal rims  38   a ,  38   b . Due to the magnetic attraction between the two magnetic cores  36   a ,  36   b , the walls  32 ,  34  of two adjacent viscera may be sandwiched and compressed between the magnet assemblies  30   a ,  30   b , resulting in ischemic necrosis of the walls  32 ,  34  to produce an anastamosis between the two viscera. With reference back to  FIG. 1 , the two viscera may comprise the jejunum  18  and the stomach  14 , the bowel duct  12  and the duodenum  16 , or various other combinations. 
     Historically, MADs have been delivered through surgical intervention such as laparotomy, which of course is invasive and carries its own risks. The exemplary self-centering MAD of U.S. Pat. No. 5,690,656 permit delivery of the device over a wire guide and through the oral cavity, and typically under fluoroscopy. Alternatively, delivery can be accomplished by simply swallowing the magnet assemblies of the MAD and using massage under fluoroscopy to center the two magnet assemblies. Finally, delivery of the magnet assemblies has occasionally been performed endoscopically with grasping forceps, which can be time consuming and difficult. Removal of the MAD is typically accomplished allowing the magnet assemblies to pass through the gastrointestinal track naturally, or more typically with a follow-up endoscopic procedure using grasping forceps. Unfortunately, the relatively large size of the magnet assemblies can make delivery and retrieval complicated. In fact, balloon dilation of bodily lumens is often required in order to deliver the magnet assemblies to the desired location. Likewise, the size of bodily lumens is often the limiting factor in the size of the magnet assemblies that can be delivered and deployed. 
     BRIEF SUMMARY OF THE INVENTION 
     The present invention provides a magnet assembly for a magnetic anastamosis device that is minimally invasive, easily and quickly delivered, and is accurately positioned to improve the delivery procedure. According to one embodiment constructed in accordance with the teachings of the present invention, a magnet assembly for a magnetic anastamosis device includes an elongated hub and a plurality of magnetic members disposed over the elongated hub. The elongated hub is formed of a shape memory material, permitting the magnet assembly to be operable between a delivery configuration and a deployed configuration. In the delivery configuration, the elongated hub extends generally linearly, and in the deployed configuration the elongated hub forms an annular shape. In this manner, the package width of the magnet assembly is greatly reduced for delivery, thereby permitting delivery over a wire guide as well as through an access device such as a catheter. 
     According to more detailed aspects, the elongated hub is formed of a nickel titanium alloy. The elongated hub is preferably tubular and defines an inner passageway sized to receive the wire guide. The plurality of magnetic members may abut each other in the deployed configuration. Each of the plurality of magnetic members includes a hole sized to receive the elongated hub, and each hole may be sized to permit the magnetic member to slide along the elongated hub, or may be sized to provide a friction fit. In the former case, the elongated hub includes a stop formed at one end of the elongated hub to prevent the plurality of magnetic members from passing beyond the end. Alternatively, the plurality of magnetic members and elongated hub may include corresponding tabs and detents or other means for maintaining the position of the magnetic members on the elongated hub. In one form, the plurality of magnetic members each include a jacket attached to a side thereof, each jacket projecting beyond the sides to define an edge. Each edge may contact the edges of adjacent jackets to form a continuous annular “cutting” edge in the deployed configuration. 
     Another embodiment constructed in accordance with the teachings of the present invention provides a medical device for forming an anastamosis between two bodily walls, the medical device comprising a magnet assembly and an access device. The magnet assembly has an elongated hub and a plurality of magnetic members disposed over the elongated hub. The access device is structured to be coupled to the magnet assembly. The magnet assembly is biased to a deployed configuration defined by the elongated hub and plurality of magnetic members forming an annular shape. When the magnet assembly is coupled to the access device, the magnet assembly assumes a delivery configuration defined by the elongated hub and plurality of members having a generally linear configuration. According to more detailed aspects, the elongated hub is formed of a resilient material biased to the deployed configuration. Alternatively, the elongated hub is formed of a shaped memory material which takes the deployed configuration when the elongated hub is exposed to body temperature. 
     A method of delivering a magnet assembly that is part of a magnetic anastamosis device is also provided in accordance with the teachings of the present invention. A magnet assembly is provided having an elongated hub and a plurality of magnetic members disposed over the elongated hub. An access device is introduced to a position proximate a first bodily wall. The magnet assembly is coupled to the access device such that the magnet assembly assumes a delivery configuration having a generally linear shape. The magnet assembly is translated relative to the access device whereby the magnet assembly assumes a deployed configuration having a generally annular shape. 
    
    
     
       BRIEF DESCRIPTION OF THE DRAWINGS 
       The accompanying drawings incorporated in and forming a part of the specification illustrate several aspects of the present invention, and together with the description serve to explain the principles of the invention. In the drawings: 
         FIG. 1  depicts various abdominal organs; 
         FIG. 2  depicts a prior art magnetic anastamosis device; 
         FIG. 3  depicts is a plan view of magnet assembly in a deployed configuration for forming a portion of a magnetic anastamosis device constructed in accordance with the teachings of the present invention; 
         FIG. 4  is a plan view of the delivery condition of an elongated hub forming a portion of the magnet assembly depicted in  FIG. 3 ; 
         FIG. 5  is a plan view of the deployed condition of the elongated hub depicted in  FIG. 4 ; 
         FIG. 6  is cross-sectional view of the delivery configuration of the magnet assembly depicted in  FIG. 3 ; 
         FIG. 7  is a cross-sectional view showing different means for connecting the magnetic members and the elongated hub to form the magnet assembly depicted in  FIG. 3 ; 
         FIGS. 8 through 12  are perspective views showing various embodiments of magnetic members forming a portion of the magnet assembly in accordance with the teachings of the present invention; 
         FIG. 13  is a schematic illustration of the magnetic orientation of the magnetic members; 
         FIG. 14  is a schematic illustration, partially in cross-section, depicting another magnetic orientation of the magnetic members; 
         FIG. 15  is a plan view of another embodiment of a magnet assembly for forming a magnetic anastamosis device constructed in accordance with the teachings of the present invention; 
         FIG. 16  is a cross-sectional view of the magnet assembly depicted in  FIG. 15 ; 
         FIG. 17  depicts is a plan view of the magnet assembly of  FIGS. 15 and 16  in a deployed configuration; and 
         FIGS. 18-20  schematically depict delivery of two magnet assemblies for forming a magnetic anastamosis device in accordance with the teachings of the present invention. 
     
    
    
     DETAILED DESCRIPTION OF THE INVENTION 
     Turning now to the figures,  FIG. 3  depicts a single magnet assembly  40  for a magnetic anastomosis device that is used to form an anastomosis between two viscera. The magnet assembly  40  generally comprises an elongated hub  42  and a plurality of magnetic members  44  disposed over the elongated hub  42 . The deployed configuration of the magnet assembly  40  is depicted in  FIG. 3 , wherein the elongated hub  42  and the plurality of magnetic members  44  form an annular shape having an interior space  43 . It will be recognized by those skilled in the art that the magnet assembly  40  may be used in conjunction with another magnet assembly of larger or smaller size to form the magnetic anastamosis device (i.e. similar to that depicted in  FIG. 2 .) To improve delivery of the magnet assembly  40 , the magnet assembly is operable to a delivery configuration as depicted in  FIG. 6 . In the delivery configuration, the magnet assembly  40  has a reduced width, making it easier to pass through bodily lumens. 
     To achieve the delivery and deployed configurations of the magnet assembly  40 , the elongated hub  42  is structured to transition between a linear condition as depicted in  FIG. 4  and an annular condition such as the circular shape depicted in  FIG. 5 . As such, the elongated hub  42  may be constructed of a resilient material which is biased to the annular condition depicted in  FIG. 5  but may be flexed and straightened into the linear condition depicted in  FIG. 4 . Suitable resilient materials include metals (e.g. stainless steel), alloys (e.g. nickel-titanium) or polymers (e.g. polyethylene, polytetrafluorethylene (PTFE) including Teflon®, polyvinyl chloride (PVC)), and composites. Alternatively, the elongated hub  42  may be formed of a shape memory material such as nickel-titanium alloys (Nitinol), copper-aluminum-nickel, copper-zinc-aluminum, and iron-manganese-silicon alloys. That is, the shape memory material of the elongated hub  42  is structured to take the linear condition of  FIG. 4  at a first temperature, and moves into the annular condition of  FIG. 5  at a second temperature. The second temperature preferably corresponds to body temperature of the patient, or above body temperature but below tissue harming temperature, so that one can freely maneuver the device inside the body, and then inject a hot fluid over the device to trigger the shape memory. It will be recognized that the linear condition of the elongated hub  42  corresponds with the delivery configuration of the magnet assembly  40  ( FIG. 6 ) while the annular condition of the elongated hub  42  corresponds to the deployed configuration of the magnet assembly  40  ( FIG. 3 ). 
     As best seen in  FIG. 4 , the elongated hub  42  is preferably formed as a tube  46  defining an interior passageway  48  which is sized to receive an access device such as a wire guide  50 . For example, the wire guide  50  may be used to maintain the linear condition of the elongated hub  42  when it is constructed of a resilient material that is biased to the annular condition ( FIG. 5 ). In either construction of the elongated hub  42  (i.e. biased or shape memory), the ability to couple the elongated hub  46  and magnet assembly  40  to a wire guide  50  is useful in navigating the magnet assembly  40  to the desired location for forming the anastomosis. For example, it will be recognized by those skilled in the art that the wire guide  50  may include radiopaque markers permitting tracking of the distal tip of the wire guide  50  such that the delivery point of the magnet assembly  40  may be readily and easily monitored by the physician under fluoroscopy. 
     Turning to  FIG. 6 , it will be recognized that an alternate access device such as a catheter or cannula  54  may be used to maintain the magnet assembly  40  in its delivery configuration, while also providing access to the desired location within the viscera on which the procedure will be formed. The cannula  54  defines an interior space  55  receiving the magnet assembly  40  therein. A pusher  56  may be used to translate the magnet assembly  40  within the cannula  54  or simply to maintain its position therein. As with the wire guide  50 , the cannula  54  may include radiopaque markers  57  permitting tracking of the access device under feroscopy for accurate positioning of the magnet assembly  40 . It will also be recognized by those skilled in the art that the cannula  54  may be used alone or in conjunction with a wire guide  50  for navigation of the bodily lumens and delivery of the magnet assembly  40 . 
     As also seen in  FIG. 6 , the plurality of magnetic members  44  are axially spaced along the elongated hub  42 . In particular, each magnetic member  44  is located on the exterior of the elongated hub  42  and includes a hole  52  sized to receive the elongated hub  42 . Turning to  FIG. 7 , a few of the numerous ways in which the magnetic members  44  may be coupled to the elongated hub  42  have been depicted. By way of example, magnetic member  44   a  includes a hole  52   a  which is sized larger than an outer diameter of the elongated hub  42  and thus is axially translatable therealong. The magnetic member  44   b  has been shown as soldered to the elongated hub  42 , although numerous related means such as welding or adhesives may also be employed. The magnetic member  44   c  includes a protective coating  58  which may be formed of various materials such as polymers like Teflon® or Paralene® for protection of the magnetic core from the corrosive effects of digestive acids or other bodily fluids depending upon the body structure involved. It will also be recognized that the magnetic member  44   c  depicts a friction fit with the elongated hub  42 , which may be employed regardless of whether the coating  58  is used. Finally, magnetic member  44   d  depicts a corresponding detent  60  and tab  62  which may be formed on the hub  42  and magnetic member  44   d.    
     The magnet assembly  40  as depicted in  FIGS. 3-7  has a general ring or disc shape (i.e. having an axial height which is less than the outer diameter of the magnetic member  44 ) which may be circular, oval or ovoid, square or the like, and it will also be recognized by those skilled in the art that the magnetic members  44  may take numerous sizes and shapes, a few of which have been depicted in  FIGS. 8-12 . The magnetic member  44   e  of  FIG. 8  has been depicted as generally cubular. The magnetic member  44   f  of  FIG. 9  has been depicted as generally cylindrical. The magnetic member  44   g  of  FIG. 10  has been depicted as polygonal and specifically hexagonal, while also being elongated. The magnetic member  44   h  of  FIG. 11  has been depicted as a generally trapezoidal body, the trapezoidal shape existing in a plane generally parallel to the elongated hub  42 . The trapezoidal shape is denoted by a radially inner side  64  which is smaller in length than a larger radially outer side  66 . It will be recognized by those skilled in the art that the trapezoidal shape of magnetic member  44   h , as well as related wedge or pie shapes, has particular usefulness when a continuous upper or lower surface of the magnet assembly  40  is desired. That is, the angled side surfaces  65  will abut adjacent side surfaces  65  of the neighboring magnetic members  44   h . As such, the angling of side surface  65  and the relative sizes of opposing surfaces  64 ,  66  may be selected depending upon the number of magnetic members  44   h  and the radius of the annular deployed configuration ( FIG. 3 ). Finally, the magnetic member  44   i  of  FIG. 12  is formed as an oblong bead. Numerous other shapes of the magnetic members  44  may be readily envisioned by those skilled in the art. 
     As shown in  FIGS. 13 ,  14  and  15 , each magnetic member  44  may be designed to have its magnetic north and south poles divided by virtually any plane. For example, in  FIG. 13  the north portion  70  and south portion  72  of the magnetic member  44  has been separated along a transverse plane (indicated by dotted line), generally perpendicular to the axis of the elongated hub  42 . In  FIG. 14 , each magnetic member  44  has its north portion  74  and south portion  76  divided along an annular plane (indicated by dotted line), generally parallel to the axis of the elongated hub  42 . It will also be recognized that in the embodiment of  FIG. 14 , when the magnetic members  44  are permitted to slide axially over the elongated hub  42 , a stop  68  may be formed at the ends of the elongated hub  42  to keep the magnetic members  44  disposed over the elongated hub  42 . In  FIG. 16 , the magnetic member  44   h  has its north portion  78  separated from its south portion  80  by a longitudinal plane (indicated by dotted line) parallel with the axis of the elongated hub  42 . 
     It can also be seen in  FIGS. 15 and 16  that another embodiment of the magnet assembly  40   h  has been depicted which utilizes the trapezoidal magnetic members  44   h  of  FIG. 11 . As previously noted, the magnetic members  44   h  may be sized whereby in the deployed configuration the side surfaces  65  abut to form a continuous upper and lower annular surface, as best seen in  FIG. 16 . Again, the magnetic members  44   h  leave an interior space  43   h  in the deployed configuration. To accommodate the magnetic members  44   h  in both the delivery and deployed configurations, each member  44   h  includes an elongated hole  52   h  for receiving the elongated hub  42 . Preferably the holes  52   h  have a width equal to or greater than an outer diameter of the elongated hub  42  so that the free ends of the hub  42  may be received side-by-side in the deployed configuration as depicted in  FIG. 15 . It will be recognized that the magnet assembly  40   h  is not limited to side-by-side free ends of the elongated hub  42 , and by way of example the free ends could be telescopically received, structured for coaxial mating, or the elongated hub  42  constructed differently to accommodate the configurations, such as being formed of a flat wire or strip, of a material which stretches, or numerous other constructions. 
     It will also be recognized that the magnetic member  44   h  has been modified to include a jacket  82  attached to a side thereof, and particularly the larger radially outward surface  66  depicted in  FIG. 11 . Each jacket  82  projects beyond the adjacent sides (i.e. upper and lower sides on the page) to define an edge  84 . As such, in the deployed configuration of  FIG. 16 , each edge  84  contacts the edges of adjacent jackets  82  to form a continuous annular edge in the deployed configuration. The coupling of magnet assembly  40   h  to another magnet assembly of smaller or larger size and having a similar flange  82  results in automatic self-centering, as well as the continuous edge of the smaller magnet assembly acting as a cutting edge in order to accelerate the process of ischemic necrosis of the tissue captured between the two magnets, thereby forming the anastamosis more quickly. 
     It will be recognized that the jackets  82  may be employed with any shape of magnetic members  44 , and thus the edges  84  need not contact each other to form a continuous annular edge. For example,  FIG. 17  depicts a magnet assembly  140  much like that of  FIG. 3  wherein each of the magnetic members  144  includes a jacket  182  that is spaced from adjacent jackets  182 , but nonetheless forms a sufficient cutting edge to accelerate ischemic necrosis. Alternatively, a longer magnet assembly  140  could be employed and the jackets  182  attached to the radially inner area of the magnetic members  144  so that a continuous annular edge is formed around the interior space  143 . 
     Although one magnet assembly  40 ,  140  has been described, two magnet assemblies are intended for use together as a magnetic anastamosis device, as previously indicated. At least one of the two magnet assemblies is a magnet assembly constructed in accordance with the teachings of the present invention. For example,  FIG. 18  depicts a first magnet assembly  40   h ( i ) (similar to the magnet assembly  40   h  depicted in  FIGS. 15-16 ) being delivered into the duodenum  16  using the delivery catheter  54 . In the figure, the deployed configuration of the magnet assembly  40   h ( i ) has been illustrated in dashed lines.  FIG. 19  depicts a second magnet assembly  40   h ( ii ) being delivered into the stomach  14  using the delivery catheter  54 , the second magnet assembly  40   h ( ii ) having a different diameter than the first magnet assembly  40   h ( i ), but otherwise being similarly constructed. As shown in the enlarged cross-sectional view of  FIG. 20 , the two magnet assemblies  40   h ( i ),  40   h ( ii ) become attracted together to sandwich the tissue  14 ,  16  therebetween, eventually causing necrosis of the tissue and an anastamosis. Further details of methods for delivering one or more magnet assembly are described hereinbelow. 
     Accordingly, it will be recognized by those skilled in the art that the magnetic anastamosis device employing the magnet assemblies  40  of the present invention not only preserves the benefits of improving the time to form an anastamosis, but further provides a smaller delivery configuration which may be easily located within the body for accurate delivery. As such, the present invention also encompasses a method for delivering the magnet assembly to a position for forming an anastamosis between two viscera. The method includes introducing an access device into one of the viscera, such as the wire guide  50  or cannula  54  depicted in  FIGS. 4 and 6  respectively. The magnet assembly is coupled to the access device such that the magnet assembly takes the delivery configuration depicted in  FIG. 6  where the elongated hub and plurality of magnetic members extend generally linearly. Upon translation of the magnet assembly relative to the access device, the magnet assembly takes a deployed configuration ( FIG. 3 ,  FIG. 15 ) within the viscera where the elongated hub and plurality of magnetic members form an annular shape. The access device may be placed within the viscera and then the magnet assembly be translated along the access device to the desired location, or the access device and magnet assembly may be coupled together and then translated together into the viscera. The combined medical device for performing an anastamosis between two viscera thus includes both the magnet assembly and the access device which cooperate together to permit the delivery of the magnet assembly to a desired location. 
     When the elongated hub  42  is simply biased to its annular condition ( FIG. 5 ) the access device is used to maintain the elongated hub  42  in its linear condition and the magnet assembly  40  and its delivery configuration. Thus, upon decoupling of the magnet assembly and access device, the magnet assembly will automatically assume its deployed configuration. When the elongated hub  42  is formed of a shape memory material such as nitinol, the increased temperature of the patient&#39;s body will cause the elongated hub  42  to take its annular condition ( FIG. 5 ) and the magnet assembly  40  will assume its deployed configuration ( FIG. 3 ). Likewise, a lower temperature fluid may be delivered to the magnet assembly at a later time to cause it to resume its delivery configuration ( FIG. 6 ) (or the material of the elongate hub  42  can be formed to include a stress induced martensite (SIM) phase such that sufficient stress on the hub  42  causes it to become more plastic and able to take the delivery configuration) whereby forceps or another device may be used to withdraw the magnet assembly onto a wire guide or within a cannula or other access device for removal from the patient. In both cases, upon formation of the anastamosis the magnets may be permitted to pass through the body naturally or may be removed by other means such as laporotic removal, endoscopic removal or other procedure. 
     The foregoing description of various embodiments of the invention has been presented for purposes of illustration and description. It is not intended to be exhaustive or to limit the invention to the precise embodiments disclosed. Numerous modifications or variations are possible in light of the above teachings. The embodiments discussed were chosen and described to provide the best illustration of the principles of the invention and its practical application to thereby enable one of ordinary skill in the art to utilize the invention in various embodiments and with various modifications as are suited to the particular use contemplated. All such modifications and variations are within the scope of the invention as determined by the appended claims when interpreted in accordance with the breadth to which they are fairly, legally, and equitably entitled.