Abstract:
A magnamosis system for auto-anastomosing a region of the body using implants with magnetic members that may be individually delivered to different locations in the body. The implants with their magnetic members have a mating surface and polar alignment that generates an attractive force to compress tissue in the region between them. The tissue in the region necroses as a result of the compressive force such that tissue surrounding the necrosed tissue heals together to form an anastomosis.

Description:
CROSS-REFERENCE TO RELATED APPLICATIONS 
       [0001]    This application claims priority from U.S. Provisional Patent Application 61/614,630 filed Mar. 23, 2012, which is incorporated herein by reference. 
         [0002]    This application is a continuation-in-part of U.S. patent application Ser. No. 13/428,122 filed Mar. 23, 2012. U.S. patent application Ser. No. 13/428,122 filed Mar. 23, 2012 is a continuation of U.S. patent application Ser. No. 12/189,330 filed Aug. 11, 2008, which is incorporated herein by reference. U.S. patent application Ser. No. 12/189,330 filed Aug. 11, 2008 is a continuation-in-part of U.S. patent application Ser. No. 11/677,700 filed Feb. 22, 2007, incorporated herein by reference in its entirety, which is a continuation-in-part of U.S. patent application Ser. No. 11/431,416 filed on May. 9, 2006, incorporated herein by reference in its entirety, which is a continuation-in-part of U.S. patent application Ser. No. 10/954,995 filed on Sep. 29, 2004, incorporated herein by reference in its entirety. 
     
    
     FIELD OF THE INVENTION 
       [0003]    The invention relates to methods, devices and systems for performing anastomosis. In particular, the invention relates to magnamosis devices, which are devices for performing anastomosis using magnets for applying compressive force between two structures. 
       BACKGROUND OF THE INVENTION 
       [0004]    Anastomosis is the connection of two structures. It refers to connections between blood vessels or between other tubular structures such as loops of intestine. An example of surgical anastomosis occurs when a segment of intestine is resected and the two remaining ends are sewn or stapled together (anastomosed) to re-establish continuity of the bowel, for example Roux-en-Y anastomosis. The procedure is referred to as intestinal anastomosis. The present invention advances the art by providing new devices to perform anastomosis. 
       SUMMARY OF THE INVENTION 
       [0005]    A magnamosis system is provided for performing an anastomosis. The system has two implants each distinguishing a casing with a magnet. The magnets are of opposite polarity. The casings have mating surfaces. A first implant defines a convex mating surface, and the convex mating surface has a first radius. The second implant defines a concave mating surface and the concave mating surface extends within the body of the second implant. The concave mating surface has a second radius, such that the second radius is greater than the first radius. 
         [0006]    While the convex mating surface faces the concave mating surface, a magnetic mating of the surfaces, caused by the magnets, causes the convex mating surface of the first implant to extend within the body of the second implant and apply a non--uniform compressive force across two adjacent structures disposed in between the two mating surfaces. The non-uniform compressive force is capable of forming an anastomosis between the two adjacent structures. 
         [0007]    To ensure the magnamosis system is exerting a force above a certain threshold, an additional element that measures force, distance or some other relatable measurement could be included in magnamosis implants. Accordingly, various examples are provided with force sensors. Furthermore, embodiment of the implants could have different forms, shapes and sizes as well as implants with or without through holes. 
     
    
     
       BRIEF DESCRIPTION OF THE DRAWINGS 
         [0008]      FIG. 1  shows a magnamosis system  100  with a first implant  110  and a second implant  120  for performing an anastomosis according to an exemplary embodiment of the invention. Both implants  110  and  120  are without through holes. 
           [0009]      FIGS. 2-4  show magnamosis systems  200 ,  300  and  400  similar to magnamosis system  100  with the difference of also having force sensors  210 ,  310  and  410 , respectively. 
           [0010]      FIG. 5  shows according to an exemplary embodiment of the invention a view of magnamosis system  500 . Both implants  510  and  520  are without through holes. 
           [0011]      FIG. 6  shows according to an exemplary embodiment of the invention a view of magnamosis system  600 . Both implants  610  and  620  do have through holes. 
           [0012]      FIG. 7  shows according to an exemplary embodiment of the invention a view of magnamosis system  700 . Both implants  710  and  720  have oval/ellipsoidal shaped through holes. 
           [0013]      FIG. 8  shows a magnamosis system  800  with a first implant  810  and a second implant  820  for performing an anastomosis according to an exemplary embodiment of the invention. Both implants  810  and  820  have through holes. 
           [0014]      FIGS. 9-11  show magnamosis systems  900 ,  1000  and  1100  similar to magnamosis system  800  with the difference of also having force sensors  910 ,  1010  and  1110 , respectively. 
           [0015]      FIG. 12  shows according to an exemplary embodiment of the invention a system  1200  with a set of integrated first implants  1210  and a set of to integrated second implants  1220 . 
       
    
    
     DETAILED DESCRIPTION 
       [0016]      FIG. 1  shows a magnamosis system  100  with a first implant  110  and a second implant  120 . First implant  110  has a first casing  112  (defining a body) that encloses a first magnet  114  with a first magnetic polarity. First casing  112  defines a convex mating surface  116  with a first radius. 
         [0017]    Second implant  120  has a second casing  122  (defining a body) that encloses a second magnet  124  with a second magnetic polarity opposite from the first magnetic polarity. Second casing  122  defines a concave mating surface  126  that extends within the body of the second implant  120 . Concave mating surface  126  has a second radius, whereby the second radius is greater than the first radius as shown in  FIG. 1 . In one example, the convex mating surface is a single convex mating surface and the concave mating surface is a single concave mating surface. 
         [0018]    While the convex mating surface  116  faces the concave mating surface  126 , a magnetic mating of the two surfaces, caused by the two magnets, causes the convex mating surface  116  of the first implant  110  to extend within the body of the second implant  120  and apply a non-uniform compressive force across two adjacent structures disposed in between the two mating surfaces. The non-uniform compressive force is capable of forming an anastomosis between the two adjacent structures. In addition, the non-uniform compressive force across the two adjacent structures increases radially inward toward the center of the two surfaces. 
         [0019]    One of the possibly complicating clinical issues with the use of the magnamosis system for creating compression anastomosis in e.g. a bowel is for the surgeon to know that the system is exerting enough force to ensure a proper anastomosis formation. In certain circumstances, if the bowel is too thick, an anastomosis could not form correctly. To ensure the magnamosis system is exerting a force above the known threshold, an additional element that measures force, distance or some other relatable measurement could be included in magnamosis implants. 
         [0020]    Accordingly,  FIGS. 2-4  show magnamosis systems  200 ,  300  and  400 , which are the same as system  100  shown in  FIG. 1 , with the difference of the addition of a force sensor  210 ,  310  and  410  respectively. Each of the force sensors, in the different examples of  FIGS. 2-4 , measures the attractive magnetic force caused by the two magnets during the magnetic mating of the two surfaces. 
         [0021]      FIG. 2  shows force sensor  210  inside the first casing  112  located underneath the convex mating surface  116  (i.e. in between convex mating surface  116  and first magnet  114 ).  FIG. 3  shows force sensor  310  inside the second casing  122  located underneath the concave mating surface  126  (i.e. in between concave mating surface  126  and second magnet  124 ). 
         [0022]    Force sensors  210  and  310  could be various types of force sensors. In one example, the force sensor, resistor or gauge could ensure that the magnamosis system is exerting a force above a certain threshold or resistance. Such a sensor acts like an on/off sensor and be triggered when a certain force threshold is reached. An example of a force threshold for clinical use is approximately 4 N (1 lb) and the sensitivity does not have to be very high. In case the threshold is reached, the circuit closes and transmits a signal (e.g. wirelessly) via radio frequency identification technology. An external reader both wirelessly powers the internal device as well as reads the signal to ensure the implanting surgeon that the correct force has been met and the device will function as intended. The signal from the force sensor could also be translated to a visual or audible signal that alerts the surgeon that a threshold pressure has been achieved. 
         [0023]    In another example of force sensors  210  and  310 , one could have a calibrated spring. The spring is calibrated so that when the two implant surfaces are mating and the proper attractive force between the magnets is achieved the spring compresses completely. When the magnet is suspended in the center of the casing indicating no coupling a dark line painted on the magnet is visible through a small opening in an opaque material lining the casing. When for example the first implant couples with the second implant and compresses the spring the dark line is hidden and the reflective surface of the magnet is exposed through the opening. This then could serve as a visual indicator if the surgeon had visual contact with the magnamosis system. If the clinical procedure prevents direct visualization of the magnamosis system, it can be mounted on a delivery device that contains an integrated light (e.g. LED) and a photo detector. The light and photo detector would be oriented such that both were facing the magnamosis system and lined up with the small opening in the opaque material mentioned above. When the magnamosis system is not coupled with another device the dark line on the magnet is visible through the opening and the photo detector will detect very little light reflected from light source. However, when an implant is coupled, the reflective surface of the magnet will be visible through the opening and the photo detector will see a large amount of light reflected from the light source. This signal from the photo detector can be directly correlated to how much the spring has deflected and therefore how much attraction force there is between the magnets of the two implants. 
         [0024]    In still another example, FIG,  4  shows a Hall effect sensor  410  to indirectly sense a magnetic field strength (flux) caused by the two magnets,  114  and  124 . Hall effect sensor  410  can be embedded in, located outsides or near the magnamosis system  400  as long as it is able to detect the magnetic flux caused by the two magnets. For example, when the second implant  120  mates with the first implant  110 , the magnetic flux will increase by an amount that is directly related to the attractive force between the two implants. The force between the implants is a function of distance and magnetic strength. By measuring the increase (or change) in magnetic flux, the amount of force can be determined by indirectly measuring the distance between the magnets. The measured or determined data can then be displayed to the surgeon. 
         [0025]    The implants of the magnamosis system according to the invention could be with or without through holes. The examples of  FIGS. 1-5  are implants without through holes, whereas the examples of  FIGS. 6-12  are with through holes. The magnamosis system  500  shows first implant  510  and second implant  520  analogous to two discs or two English muffins. The magnamosis system  600  shows first implant  610  and second implant  620  analogous to two Donuts with through holes  612  and  622 , respectively. The implants could be circular or ellipsoidal/oval.  FIG. 7  shows a magnamosis system  700  where implants  710  and  720  as well as the respective through holes  712  and  722  have an oval shape. Irrespective of the size or shape, the implants conform to the convex and concave mating surfaces with different radii as described supra. 
         [0026]    The choice of the shape of the magnamosis system and existence of through holes depends on the clinical applicability and use. Different sizes and shapes of the device accommodate different clinical situations. As one might expect, a smaller person will most likely require a smaller bowel anastomosis than a larger person would. The simplest solution to accommodate these clinical issues is to have different diameter devices. However, this may not provide the best solution for every case. With a circular magnamosis system one can only create an anastomosis that is less than the diameter of that patient&#39;s bowel. In some clinical applications, it may be advantageous to create a larger anastomosis. 
         [0027]    A larger anastomosis can be obtained by an anastomosis system with an oval shape according to  FIG. 7 . The oval shape increases the area of the anastomosis without increasing the space necessary to implant it. The oval does need not to be a traditional oval shape. The long edges of the oval could be parallel to further increase the size of the hole, but it is not necessary that they be so. 
         [0028]    A larger or different type of anastomosis could also be achieved by having sets of multiples of the first and second implants forming a magnamosis system.  FIG. 12  shows an example with two first implants  1210  and two second implants  1220 . The implants in each set could be encased in the same casing, or somehow attached to each other. It is important to note that the convex and concave mating surfaces with different radii as described supra remains in place for each implant in the respective sets. One can image various structures, arrays and shapes varying based on the example of  FIG. 12  all of which are part of the scope of the invention. 
         [0029]      FIG. 8  shows a magnamosis system  800  with a first implant  810  and a second implant  820 . First implant  810  has a first casing  812  (defining a body) that encloses a first magnet  814  with a first magnetic polarity. First casing  812  further has a first through hole  818  and a terminal structure defining a convex mating surface  816  with a first radius. 
         [0030]    Second implant  820  has a second casing  822  (defining a body) that encloses a second magnet  824  with a second magnetic polarity opposite from the first magnetic polarity. Second casing  822  further has a second through hole  828  and a terminal structure defining a concave mating surface  826  that extends within the body of the second implant  820 . Concave mating surface  826  has a second radius, whereby the second radius is greater than the first radius as shown in  FIG. 8 . In one example, the convex mating surface is a single convex mating surface and the concave mating surface is a single concave mating surface. 
         [0031]    While the convex mating surface  816  faces the concave mating, surface  826 , a magnetic mating of the two surfaces, caused by the two magnets, causes the convex mating surface  816  of the first implant  810  to extend within the body of the second implant  820  and apply a non-uniform compressive force across two adjacent structures disposed in between the two mating surfaces. The non-uniform compressive force is capable of forming an anastomosis between the two adjacent structures. In addition, the non-uniform compressive force across the two adjacent structures increases radially inward toward the first and second through-holes,  818  and  828 . 
         [0032]    Accordingly,  FIGS. 9-11  show magnamosis systems  900 ,  1000  and  1100 , which are the same as system  800  shown in  FIG. 8 , with the difference of the addition of a force sensor  910 ,  1010  and  1110  respectively. Each of the force sensors, in the different examples of  FIGS. 9-11 , measures the attractive magnetic force caused by the two magnets during the magnetic mating of the to surfaces. 
         [0033]      FIG. 9  shows force sensor  910  inside the first casing  812  located underneath the convex mating surface  816  (i.e. in between convex mating surface  816  and first magnet  814 ).  FIG. 10  shows force sensor  1010  inside the second casing  822  located underneath the concave mating surface  826  (i.e. in between concave mating surface  826  and second magnet  824 ). In still another example,  FIG. 11  shows a Hall effect sensor  1110  to indirectly sense a magnetic field strength (flux) caused by the two magnets,  814  and  824 . The examples of sensors described with respect to FIG&amp;  2 - 4  would apply to the example of sensor for  FIG. 941 . 
         [0034]    In general and applicable to the embodiments described herein, the non-uniform compressive force could be strong enough to generate a necrosis tissue region of two adjacent structures. The necrosis tissue region could depart from the two adjacent structures to form a flow passage. Such a flow passage could form a fistula, and the fistula could pass the implants therethrough. Furthermore, the non-uniform compressive force could generate a force at the perimeter of the implants that is strong enough to fuse two adjacent structures while still promoting tissue growth within the two fused structures, 
         [0035]    The casing for each implant can either fully enclose the magnet and force sensor if applicable. However, this does not have to be the case since it is only important that the mating surface are fully covered or enclosed and that the magnet and/or force sensor remain one unit. For example, aspects of the non-facing sides could remain open, i.e. not enclosed. Therefore, we refer to the fact that the casings at least partially enclosed the magnets. 
         [0036]    The casings could be made out of plastic like a polycarbonate, but any other material is applicable as long as it does not interfere with the magnetic fields of the magnets. The size and shape of the magnets could vary as long as they are capable of generating the non-uniform compressive force as described. The location of magnets inside the casing could vary, but it is typically important that they cover a large enough area to again generate the non-uniform compressive force. The magnets in general extend underneath the surface area of mating surfaces. 
         [0037]    Force sensors could be combined. For example, one could have a magnamosis system with force sensors in each implant as well as a Hall effect sensor. One can imagine various combinations of sensors which are all applicable and useful to the invention. 
         [0038]    Further teachings and embodiments are described in U.S. patent application Ser. No. 12/189,330 filed Aug. 11, 2008 now U.S. Pat. No. 8,142,454 issued on Mar. 27, 2012, which is herein incorporated by reference in its entirety.