Abstract:
A system and method for treating obesity including a first instrument containing a first magnet therein, the first instrument insertable into a stomach of a patient and the first magnet deployable into the stomach of the patient and having a first space. A second instrument contains a second magnet therein, the second instrument insertable into a bowel of a patient and the second magnet deployable into the bowel of the patient and having a second space. A stent is insertable into the first and second spaces to maintain an opening formed between the stomach and bowel.

Description:
BACKGROUND OF THE INVENTION 
       [0001]    This application claims priority from provisional application Ser. No. 62/062,366, filed Oct. 10, 2014, the entire contents of which are incorporated herein by reference. 
         [0002]    1. Field of the Invention 
         [0003]    The application relates to system and method treating obesity, and, more particularly, to a system and method for performing gastric bypass. 
         [0004]    2. Background of the Related Art 
         [0005]    The incidence of obesity continues to increase worldwide. Obesity has been defined in terms of a body mass index greater than 30, with body mass index defined by weight in kilograms divided by the square of the height in meters. (Overweight is defined as a body mass index of over 25). Obesity can cause a number of serious health conditions such as hypertension, diabetes, certain forms of cancer, coronary artery disease, stroke, congestive heart failure, and venous disease. Obesity can also cause orthopedic problems, skin problems and respiratory difficulties. 
         [0006]    A variety of methods are currently being utilized to treat obesity. In general, these procedures fall into two categories: procedures which restrict food intake or procedures which alter the anatomy of the small intestine or divert the peristalsis of a person&#39;s food intake past the small intestine to decrease caloric absorption. 
         [0007]    Some methods are designed to reduce the stomach by partition or bypass such as by stapling or tying off portions of the large or small intestine or stomach to reduce the amount of food desired by the patient, and the amount absorbed by the intestinal tract. In gastric banding, an adjustable band is placed externally of the stomach to constrict a portion of the stomach. Such treatments are designed to reduce the caloric intake of the individual by more rapidly triggering the satiety impulse or limiting the amount of food the individual can ingest. Complications can occur as the individual, due to the stomach restriction, may not be intaking sufficient nutrients. 
         [0008]    Laparoscopic methods of banding and vertical banded gastroplasty have been developed, which although provide the advantages of minimally invasive surgery compared to open surgery such as less trauma, less hospital stay and faster recovery, are complicated to perform. 
         [0009]    The need exists for an improved system and method for treating obesity. 
       SUMMARY OF THE INVENTION 
       [0010]    The present invention advantageously provides a minimally invasive system and method for treating obesity. 
         [0011]    In accordance with a first aspect, the present invention provides a method for treating obesity comprising the steps of: 
         [0012]    inserting first and second endoscopes, the first endoscope inserted into a stomach of the patient and the second endoscope inserted into a bowel of a patient; 
         [0013]    delivering a penetrating device to penetrate a wall of the stomach and a wall of the bowel; 
         [0014]    approximating the bowel and stomach; 
         [0015]    deploying a first magnet in the stomach and a second magnet in the bowel; 
         [0016]    creating an opening between the stomach and bowel; and 
         [0017]    positioning a stent into the opening. 
         [0018]    In some embodiments, the step of inserting a first endoscope into the stomach includes advancing the first endoscope transorally into the stomach. 
         [0019]    In some embodiments, the method further includes the step of inserting a T-bar through the wall of the stomach and wall of the bowel and the step of approximating the bowel and stomach includes the step of pulling the T-bar proximally. 
         [0020]    In some embodiments, the first magnet is deployed from the first endoscope and the second magnet is deployed from the second endoscope. In some embodiments, the first magnet has a first opening and the second magnet has a second opening, and the step of creating an opening between the stomach and the bowel includes inserting a cutting instrument through the first and second openings of the magnets. In some embodiments, the first magnet is retained in the first endoscope in a substantially linear position and/or the second magnet is retained in the second endoscope in a substantially linear position and the first and/or second magnets move to a curved placement position after deployment from the respective endoscope. 
         [0021]    In some embodiments, the first endoscope has a first channel to receive the first magnet and a second channel to receive a device for approximating the stomach and bowel, and the step of deploying the first magnet advances the first magnet from the first channel. The first endoscope can have in some embodiments a third channel to receive the stent and the step of positioning the stent in the opening can include the step of advancing the stent from the third channel. 
         [0022]    The method can include the step of removing the first and second endoscopes and closing off a portion of the stomach. 
         [0023]    In accordance with another aspect of the present invention, a system for treating obesity is provided comprising a first instrument containing a first magnet therein, the first instrument insertable into a stomach of a patient and the first magnet deployable into the stomach of the patient and having a first space. A second instrument contains a second magnet therein, the second instrument insertable into a bowel of a patient and the second magnet deployable into the bowel of the patient and having a second space. A stent is insertable into the first and second spaces to maintain an opening formed between the stomach and bowel. 
         [0024]    In some embodiments, the first magnet is retained in the first instrument in a substantially linear position in the delivery configuration and has a curved placement configuration after deployment from the first instrument. In some embodiments, the second magnet is retained in the second instrument in a substantially linear position in the delivery configuration and has a curved placement configuration after deployment from the second instrument. 
         [0025]    In some embodiments, the stent has a first collapsed configuration when positioned in the first instrument and an expanded second position after exposure from the first instrument. 
         [0026]    In some embodiments, the first instrument has a first channel to receive the first magnet and a second channel to receive a device for approximating the stomach and bowel. In some embodiments, the first instrument has a third channel to receive the stent. 
     
    
     
       BRIEF DESCRIPTION OF THE DRAWINGS 
         [0027]    So that those having ordinary skill in the art to which the subject invention appertains will more readily understand how to make and use the surgical apparatus disclosed herein, preferred embodiments thereof will be described in detail hereinbelow with reference to the drawings, wherein: 
           [0028]      FIG. 1  is a perspective view of a first endoscopic instrument of the present invention configured for transoral insertion into the stomach of a patient; 
           [0029]      FIG. 2  is a perspective view showing the first endoscopic instrument of  FIG. 1  positioned in the stomach and a second endoscopic instrument inserted in the bowel; 
           [0030]      FIG. 3A  is a front perspective view of the first endoscopic instrument of  FIG. 1 ; 
           [0031]      FIG. 3B  is a front perspective view of an alternate embodiment of the first endoscopic instrument of the present invention; 
           [0032]      FIG. 4  is a perspective view of one of the magnets of the present invention in the elongated delivery configuration; 
           [0033]      FIG. 5A  is a perspective view of the magnet of  FIG. 4  in a circular placement configuration; 
           [0034]      FIG. 5B  is a perspective view of the magnet of  FIG. 4  in an alternate C-shaped placement configuration; 
           [0035]      FIGS. 6-20  illustrate the method of use of the system of the present invention wherein 
           [0036]      FIG. 6  illustrates the second endoscopic instrument being inserted into the bowel; 
           [0037]      FIG. 7  illustrates the first endoscopic instrument being inserted into the stomach via a transoral approach; 
           [0038]      FIG. 8  illustrates a needle and T-bar delivery sheath being advanced from the first endoscopic instrument of  FIG. 1  and further showing the second endoscopic instrument positioned in the bowel; 
           [0039]      FIG. 9  is a view similar to  FIG. 8  showing the needle advanced from the delivery sheath to puncture the stomach wall; 
           [0040]      FIG. 10  is a view similar to  FIG. 9  illustrating the needle and T-bar inserted through the stomach wall and into the bowel; 
           [0041]      FIG. 11  is a view similar to  FIG. 10  showing movement of the T-bar proximally to approximate the stomach and bowel walls, and further showing initial deployment of the sheath containing the first magnet; 
           [0042]      FIG. 12  is a view similar to  FIG. 11  showing initial deployment of the first magnet from the sheath; 
           [0043]      FIG. 13  is a view similar to  FIG. 12  showing the first magnet fully released from the first endoscopic instrument and positioned in the stomach, and further showing initial deployment from the second endoscopic instrument the second sheath containing the second magnet; 
           [0044]      FIG. 14  is a view similar to  FIG. 13  showing initial deployment of the second magnet from the sheath; 
           [0045]      FIG. 15  is a view similar to  FIG. 14  showing the second magnet fully released from the second endoscopic instrument and positioned in the bowel adjacent the bowel wall and the attraction of the second and first magnets to maintain the approximated position of the stomach and bowel walls; 
           [0046]      FIG. 16  is a view similar to  FIG. 15  illustrating a puncturing device advanced from the first endoscopic instrument and being inserted through the space (opening) in the first magnet; 
           [0047]      FIG. 17  is a view similar to  FIG. 16  showing initial deployment of a sheath containing a stent from the first endoscopic instrument; 
           [0048]      FIG. 18  is a view similar to  FIG. 17  illustrating advancement of the stent sheath through the openings in the magnets; 
           [0049]      FIG. 19  is a view similar to  FIG. 18  illustrating placement of the stent in the space between the first and second magnets to maintain the opening between the stomach and bowel, and further showing the first and second endoscopic instruments being withdrawn; and 
           [0050]      FIG. 20  illustrates the stent positioned in the stomach and bowel and the endoscopic instruments removed. 
           [0051]      FIG. 21  is a flow chart showing the procedural steps of the system of the present invention. 
       
    
    
     DETAILED DESCRIPTION OF PREFERRED EMBODIMENTS 
       [0052]    Referring now to the drawings wherein like reference numerals identify similar structural features of the apparatus disclosed herein, there is illustrated in  FIG. 1  a first endoscopic instrument, designated generally by reference numeral  10 . The first endoscopic instrument  10  of the system is configured to be inserted transorally into the stomach S, as shown in  FIG. 2 . A second endoscopic instrument  12  ( FIG. 2 ) of the system is configured to be inserted into the bowel minimally invasively through a port (not shown). The two instruments  10 ,  12  deliver first and second magnets, respectively, in performance of a gastric bypass procedure explained in detail below. 
         [0053]    As shown in  FIG. 1 , endoscopic instrument  10  is in the form of an endoscope having visualization capabilities. Endoscopic instrument  10  has a flexible outer tube  14  and a handle  16  with optional access ports  16   a,    16   b  for insertion of instruments, insertion of fluid, and/or aspiration. Instruments inserted through the instrument  10  exit the distal end  15 . The flexible tube  14  is dimensioned for insertion through the natural opening of the mouth of the patient and through the esophagus into the patient&#39;s stomach to provide a minimally invasive entry into the stomach. In alternate embodiments, the endoscopic instrument  10  can be configured for insertion through an access port for minimally invasive entry into the stomach through a small surgeon-created opening. 
         [0054]    The second endoscopic instrument  12 , as shown in  FIG. 8 , has a distal end  13 , imaging lens  17   a,  an illumination lens or window  17   b  for the light delivery system, and a lumen  19  to receive a magnet delivery device  49  ( FIG. 13 ) which contains a second magnet described below. The second endoscopic instrument  12  can have flexible tube, handle and access ports as in the first endoscopic instrument  10 . 
         [0055]    Note the designations of “first” and “second” for the various components and instruments, e.g., endoscopic instruments and magnets, as used herein are merely to identify the separate instruments and components and are not necessarily designated in the order of insertion. For example, the first endoscopic instrument can be inserted before or after the second endoscopic instrument, and the first magnet can be inserted before or after the second magnet. 
         [0056]    As used herein, the term “proximal” denotes the portion of the instrument closer to the user and the term “distal” denotes the portion of the instrument further from the user. 
         [0057]    In the embodiment of  FIG. 3A  (and  FIG. 8 ), the first endoscopic instrument  10  has four working channels (lumens), an imaging lens  18   a  for visualization of the surgical site and an illumination lens or window  18   b  for the light delivery system for illuminating the surgical site. The four working channels or lumens are for the various components of the system which are deployable from the instrument  10  for performing the gastric bypass procedure. More specifically, lumen  22  receives a magnet delivery device  40  for delivering a magnet  42  adjacent the inner stomach wall, lumen  24  receives a sheath  30  for delivering a needle  32  and T-bar  34  for approximating the wall of the stomach and the wall of the bowel, lumen  26  receives a cutting instrument (device)  36  for cutting an opening between the deployed magnet  42  and a second magnet which is deployed in the bowel, and lumen  28  receives a stent sheath  50  for delivery of a stent  52  in the openings in the magnets and through the approximated walls of the stomach and bowel to maintain the opening between the approximated stomach and bowel. The lumens  22 ,  24 ,  26 ,  28  can be of various sizes and the instruments can be inserted through lumens other than the particular lumen designated in  FIG. 8 , e.g., sheath  30  can be inserted through lumen  28  and stent sheath  50  inserted through lumen  24 . 
         [0058]    In the alternate embodiment of  FIG. 3B , the endoscopic instrument  60  has fewer working channels (lumens), thereby reducing the overall diameter of the instrument  10 . In this embodiment, the same channel can be used to deploy several components of the system. For example, endoscopic instrument  60  of this alternate embodiment has an imaging lens  62  and an illumination lens or window  64  for visualizing and illuminating the surgical site as in the endoscopic instrument  10  of  FIG. 3A . However, endoscopic instrument  60  has a lumen  66  for the needle  32  and T-bar  34  and a lumen  68  for the magnet delivery device  40  and magnet  42 . In this embodiment, the lumen  68  used for magnet delivery can also be used for the cutting device  36 , inserted after the magnet delivery device  40  is withdrawn from the lumen after delivery of the magnet  42 . The stent delivery device (stent sheath  50 ) can then be inserted through the lumen  68  after withdrawal of the cutting instrument  36 . Note that lumen  66  can alternatively be used for the cutting device and/or stent delivery. As can be appreciated, the embodiment of  FIG. 3B  enables a smaller diameter endoscope to be utilized since a single lumen can be used for multiple purposes. However, the embodiment of  FIG. 3A  has the advantages of quicker procedure time and ease of use as the various devices/components can be preloaded in the endoscope working channels so the user does not need to fully withdraw one device and then insert another device through the endoscope working channel as in the embodiment of  FIG. 3B . Even if not preloaded, the instrument of  FIG. 3A  still saves procedural time because one device does not have to be fully removed from the instrument before another device is inserted. 
         [0059]    The first magnet  42  is illustrated in  FIG. 4 . Preferably the magnet  42  is delivered in a substantially linear configuration, maintained in this delivery configuration (position) by a magnet delivery device (sheath)  40  (see  FIG. 11 ). When deployed from the delivery device  40 , the magnet  42  returns to a curved placement/configuration for placement at the stomach wall. In the embodiment of  FIG. 5A , the magnet  42  returns to a circular,  360  degree shape. In the alternate embodiment of  FIG. 5B , the magnet  42 ′ returns from its substantially linear delivery configuration to a C-shaped configuration so that ends  42   a  and  42   b  are spaced apart. In either embodiment, the magnet  42 ,  42 ′ has an opening or space  45 ,  45 ′ respectively, to receive a cutting device and then a stent as described in more detail below in conjunction with the method of use. Note the magnet  42 ,  42 ′, can be composed of a shape memory material such as a nickel titanium alloy, e.g., Nitinol, with a curved memorized configuration to which it returns upon deployment, e.g., a memorized position of  FIG. 5A or 5B . Other materials are also contemplated. 
         [0060]    The second magnet  48  can be the same as the first magnet  42  (or  42 ′) and its variations described above, and made of the same or alternate material as magnet  42  (or  42 ′). It is contained in the magnet delivery device (sheath)  49  ( FIG. 13 ) in a substantially linear delivery configuration (position) and delivered into the bowel for placement at the bowel wall as described below where it returns to a curved configuration in a similar manner as magnet  42  or  42 ′shown in  FIG. 5A  or  FIG. 5B . 
         [0061]    The method of use of the system of the present invention for performing gastric bypass will now be discussed in conjunction with  FIGS. 6-20 . It should be noted that the system can alternatively be used for other surgical procedures. The first endoscope or endoscopic instrument  10  is inserted transorally into the stomach S so that its distal end  15  is adjacent the stomach wall X as shown in  FIG. 7 . The second endoscope or endoscopic instrument  12  is inserted through a trocar port into the bowel B with its distal end  13  adjacent the bowel wall Z ( FIG. 7 ). Note the first endoscope  10  does not necessarily need to be inserted before the second endoscope  12 , e.g., it could alternatively be inserted after the second endoscope  12  is inserted into the bowel B. Additionally, the first and second endoscopes  10 ,  12  can be inserted via other ways into the stomach and bowel, respectively. 
         [0062]    Once positioned in the stomach S, a needle and T-bar delivery sheath  30  is advanced from lumen  24  of the endoscope  10  as shown in  FIG. 8 . The needle  32 , which carries the T-bar  34 , is advanced from sheath  30  by a pusher (not shown) to form a puncture through the wall X of the stomach S and the wall Z of the bowel to advance the T-bar  34  into the bowel B as shown in  FIGS. 9 and 10 . Sheath  30  can then be retracted or a flexible T-bar connector  33  pulled proximally to pull T-bar  34  proximally to engage the inner side of wall Z of the bowel B and to move the wall Z toward the stomach wall X to approximate the bowel B and stomach S ( FIG. 11 ). The sheath  30  can be retracted within lumen  24 . Magnet delivery sheath  40  is then advanced from the lumen  22  of the endoscope  10  ( FIG. 11 ), and a pusher (not shown) within the delivery sheath  40  advances the magnet  42  from the sheath  40 . The magnet  42  as shown is retained in a substantially linear delivery position along a longitudinal axis of the delivery sheath  40  for insertion. When the magnet  42  is exposed, it resumes its shape memory position as shown in  FIGS. 12 and 13 , and when fully exposed assumes the curved circular configuration of  FIGS. 13 and 5A  (or alternatively the C-shape as in  FIG. 5B ), placed to rest against the internal side of the stomach wall X. As shown, the circular shape of the magnet  42  has an opening  43 . 
         [0063]    Magnet delivery sheath  49  is then advanced from the lumen  19  of the endoscope  12  ( FIG. 13 ), and a pusher (not shown) within the delivery sheath  49  advances the magnet  48  from the sheath  49 . The magnet  42  is retained in a substantially linear delivery position along a longitudinal axis of the delivery sheath  49 . When the magnet  48  is exposed, it resumes its shape memory position as shown in  FIGS. 14 and 15 , and when fully exposed assumes the curved circular configuration of  FIGS. 15 and 5A  (or alternatively the C-shape like magnet  42 ′ of  FIG. 5B ), placed to rest against the internal side of the bowel wall Z. As shown, the circular shape of the magnet  48  has an opening  47 . The attraction forces of the two magnets  42  and  48  maintain the stomach and bowel walls in approximation. Note the T-bar  34  can be removed once the magnets  42  and  48  are in position to maintain the stomach and bowel walls in approximation due to the magnetic attraction forces. 
         [0064]    Once the magnets  42 ,  48  are in position, cutting instrument  36  is advanced from the lumen  26  of the endoscope  10  ( FIG. 16 ). The cutting instrument  36  is advanced through the openings  43  and  47  of magnets  42 ,  48 , respectively, to make an incision through the stomach wall X and bowel wall Z. The cutting instrument  36  is then withdrawn, and stent sheath  50  ( FIGS. 17 and 18 ) is advanced from lumen  28  of endoscope  10 . A stent  52  is contained within the stent sheath  50  in a reduced diameter collapsed position. The sheath  50  is inserted through the incision through the stomach wall X, bowel wall Z and into the bowel B. The sheath  50  is then withdrawn, or the stent  52  exposed from the sheath  50 , allowing the stent  52  to expand to a larger diameter expanded second position within openings  43 ,  47  of magnets  42 ,  48 , and leaving the stent  52  in position to maintain the opening between the stomach S and bowel B as shown in  FIG. 19 . The endoscopic instruments (or endoscopes)  10 ,  12  can then be withdrawn.  FIG. 20  shows the stent  52  in position with the endoscopes  10  and  12  removed from the body. A portion of the stomach is then closed off such as by a stapling instrument (not shown) or suturing. With the stent  52  in the position of  FIG. 20 , contents pass from the stomach into the bowel B through the openings in the stomach wall X and bowel Z. 
         [0065]    The procedure provides immediate results as the bypass opening is formed during the procedure. The surgeon can also see the opening before the patient is released due to the visualization provided by the endoscopes, thereby increasing efficacy of the procedure. 
         [0066]      FIG. 21  provides a flow chart setting forth the method steps of the present invention. The steps are as follows: insert a first endoscope (or endoscopic instrument) into the stomach, insert a second endoscope (or endoscopic instrument) into a bowel (although the second endoscope could alternatively be inserted before the first endoscope), deliver a needle and T-bar from the first endoscope to advance the needle and T-bar though the stomach and bowel, pull the T-bar proximally to approximate the bowel and stomach, deploy a first magnet from the first endoscope into the stomach against the lower wall, deploy a second magnet from the second endoscope against a wall of the jejunum (although the second magnet could alternatively be placed (deployed) before the first magnet), deploy a cutting instrument from the first endoscope to cut through the opening in the magnets to create an opening between the stomach and bowel, deliver (insert) a stent from the first endoscope into the opening between the stomach and bowel (through the openings in the magnets), remove the first and second endoscopes from the patient, and close off a portion of the stomach. Note the T-bar can be removed after placement of the first and second magnets. 
         [0067]    Note the magnets can be removed after a period of time if desired. 
         [0068]    Although the apparatus and method of the subject invention have been described with respect to preferred embodiments, those skilled in the art will readily appreciate that changes and modifications may be made thereto without departing from the spirit and scope of the present invention as defined by the appended claims.