Abstract:
An implant for placement within a hollow body organ including a member having an undeployed shape for delivery to the hollow body and a deployed shape for implantation therein. The member has a plurality of links pivotably connected to each other, and a flexible elongated tether connected to the member such that tensioning the tether places the member in the deployed shape. The member has sufficient rigidity in its deployed shape to exert an outward force against an interior of the hollow body so as to bring together two substantially opposing surfaces of the hollow body.

Description:
RELATED APPLICATION DATA 
       [0001]    This application is a continuation in Part of U.S. application Ser. No. 11/469,564, filed on Sep. 1, 2006, which is hereby incorporated herein by reference. 
     
    
     FIELD OF THE INVENTION 
       [0002]    The present invention has application in conventional open, laparoscopic and endoscopic surgical instrumentation and methods as well application in robotic-assisted surgery. The present invention has even further relation to devices implanted within the stomach to induce weight loss. 
       BACKGROUND OF THE INVENTION 
       [0003]    Morbid obesity is a serious medical condition. In fact, morbid obesity has become highly pervasive in the United States, as well as other countries, and the trend appears to be heading in a negative direction. Complications associated with morbid obesity include hypertension, diabetes, coronary artery disease, stroke, congestive heart failure, multiple orthopedic problems and pulmonary insufficiency with markedly decreased life expectancy. With this in mind, and as those skilled in the art will certainly appreciate, the monetary and physical costs associated with morbid obesity are substantial. In fact, it is estimated the costs relating to obesity are in excess of one hundred billion dollars in the United States alone. 
         [0004]    A variety of surgical procedures have been developed to treat obesity. The most common currently performed procedure is Roux-en-Y gastric bypass (RYGB). This procedure is highly complex and is commonly utilized to treat people exhibiting morbid obesity. Other forms of bariatric surgery include Fobi pouch, bilio-pancreatic diversion, and gastroplasty or “stomach stapling”. In addition, implantable devices are known which limit the passage of food through the stomach and affect satiety. 
         [0005]    In view of the highly invasive nature of many of these procedures, efforts have been made to develop less traumatic and less invasive procedures. Gastric-banding is one of these methods. Gastric-banding is a type of gastric reduction surgery attempting to limit food intake by reducing the size of the stomach. In contrast to RYGB and other stomach reduction procedures, gastric-banding does not require the alteration of the anatomy of the digestive tract in the duodenum or jejunum. 
         [0006]    However, gastric bands still require invasive surgical techniques. Recently, many new approaches to the treatment of obesity have been described in the art aiming to reduce invasiveness while maintaining effectiveness. First, restrictive procedures aim to reduce the amount of food a person can eat at a given time. One approach is endoscopic gastric restriction, which aims to create a small restrictive pouch in the proximal stomach by fastening anterior and posterior walls of the stomach together, simulating a vertical gastroplasty. Another approach is to use Restrictive sleeves. These are stent like structures, which are placed in the proximal most portion of the stomach and provide a restrictive outlet, preventing patients from overeating. Yet another approach is to use space occupying devices which maintain a constant volume in the stomach, limiting the amount of food a person can ingest at a given time. In yet another approach, physicians use balloons which expand in the stomach. While easy to install and reversible, these devices have been plagued by migration, leading to obstruction. Because of this, they have to be removed within 6 months. 
       SUMMARY OF THE INVENTION 
       [0007]    An implant for placement within a hollow body organ including a member having an undeployed shape for delivery to the hollow body and a deployed shape for implantation therein. The member has a plurality of links pivotably connected to each other, and a flexible elongated tether connected to the member such that tensioning the tether places the member in the deployed shape. The member has sufficient rigidity in its deployed shape to exert an outward force against an interior of the hollow body so as to bring together two substantially opposing surfaces of the hollow body. 
     
    
     
       BRIEF DESCRIPTION OF THE DRAWINGS 
         [0008]      FIG. 1  is an endoscopy overtube placed in the esophagus 
           [0009]      FIG. 2  is a close up of the stomach with overtube in place 
           [0010]      FIG. 3  is an overall view of the implantable coil device 
           [0011]      FIG. 4  is a close up of the distal end of the coil 
           [0012]      FIG. 5  is a close up of the proximal end of the coil 
           [0013]      FIG. 6  is an isometric view close up of the distal end of the coil 
           [0014]      FIG. 7  is an isometric view of one link with the heat stake assembly 
           [0015]      FIG. 8  is an isometric view showing the link assembly in a bent configuration 
           [0016]      FIG. 9  is an isometric view showing the top link component with the male pins 
           [0017]      FIG. 10  is an isometric view showing the bottom link component with the counter bore 
           [0018]      FIG. 11  is an isometric view showing the bottom link component with pivot boss 
           [0019]      FIG. 12  is an cross sectional view showing the pivot pin heat stake assembly 
           [0020]      FIG. 13  is various view&#39;s showing the individual features on the link assembly 
           [0021]      FIG. 14  shows isometric view&#39;s of the link connector assembly 
           [0022]      FIG. 15  is an exploded view of the proximal tip of the gastric coil 
           [0023]      FIG. 16  is a top view of an end of the coil 
           [0024]      FIG. 17  is a view of the elastomer link 
           [0025]      FIG. 18  is a view of the distal string lock with the string configuration shown 
           [0026]      FIG. 19  is a view of the proximal string lock with the string configuration shown 
           [0027]      FIG. 20  is a view of the distal string lock with the string configuration pulled into a partially deployment configuration 
           [0028]      FIG. 21  is a view showing the deployment sequence with the distal tip just entering the stomach 
           [0029]      FIG. 22  is a view showing the deployment sequence with the first three links just entering the stomach 
           [0030]      FIG. 23  is a view showing the deployment sequence with the first three links just entering the stomach and tension being placed on the pull cable 
           [0031]      FIG. 24  is a view showing the deployment sequence with the first five links entering the stomach and tension being placed on the pull cable 
           [0032]      FIG. 25  is a view showing the deployment sequence with the first five links entering the stomach and tension being placed on the pull cable 
           [0033]      FIG. 26  is a view showing the deployment sequence with the first eight links entering the stomach and tension being placed on the pull cable 
           [0034]      FIG. 27  is a view showing the deployment sequence with the first eleven links entering the stomach and tension being placed on the pull cable 
           [0035]      FIG. 28  is a view showing the deployment sequence with the distal end of the coil fully deployed in the stomach with the string lock fully locked into position 
           [0036]      FIG. 29  is a view showing the deployment sequence with the first twelve links entering the stomach and tension being placed on the distal pull cable to pull it into position 
           [0037]      FIG. 30  is a view showing the deployment sequence with the first sixteen links entering the stomach and tension being placed on both pull cable&#39;s to pull them into position 
           [0038]      FIG. 31  is a view showing the deployment sequence with the first seventeen links entering the stomach and tension being placed on the proximal pull cable to hold it in position while the flexible endoscope advances the remaining coil into the stomach 
           [0039]      FIG. 32  is a view showing the deployment sequence with the entire coil entering the stomach. 
           [0040]      FIG. 33  is a view showing the deployment sequence with the entire coil entering the stomach 
           [0041]      FIG. 34  is a view showing the deployment sequence with the entire coil deployed inside the stomach, the proximal string is being pulled to lock the proximal string lock into position. 
           [0042]      FIG. 35  is a view showing the deployment sequence with the entire coil deployed inside the stomach, Both string lock&#39;s are locked into position. 
           [0043]      FIG. 36  is a view showing the proximal pull cable being cut so the pull cable can be removed from the coil. 
           [0044]      FIG. 37  is a view showing the resultant coil configuration after the proximal pull cable is cut and removed 
           [0045]      FIG. 38  is a view showing the distal pull cable being cut so the pull cable can be removed from the coil. 
           [0046]      FIG. 39  is a view showing the resultant coil configuration after the proximal and distal pull cable are both cut and removed 
           [0047]      FIG. 40  is a view showing the resultant coil configuration after the cables, Flexible Endoscope, and Endoscopy Overtube are removed. 
           [0048]      FIG. 41  is a isometric view showing the components of the string lock assembly 
           [0049]      FIG. 42  is a isometric view showing the components of the string lock assembly 
           [0050]      FIG. 43  is a isometric view showing the string lock component by itself 
           [0051]      FIG. 44  is a top view showing the string routing with the knot prior to locking in the string lock component 
           [0052]      FIG. 45  is a top view showing the string routing with the knot after locking in the string lock component 
           [0053]      FIGS. 46 through 55  are deployment stages of the coil deployment inside the stomach 
       
    
    
     DETAILED DESCRIPTION OF THE INVENTION 
       [0054]    The preferred embodiment of the Implantable Coil is made up of individual links made from HDPE injection molded plastic with a radio-opaque additive such as barium sulfate. The material must be Biocompatible to be implanted within the body. It may be made from a variety of materials including: 
         [0055]    i. Polyetheretherketone (PEEK) 
         [0056]    ii. High Density Polyethylene (HDPE) 
         [0057]    iii. Polypropylene (PP) 
         [0058]    iv. Low Density Polyethylene (LDPE) 
         [0059]    v. Polysulfone (PSU) 
         [0060]    The individual links are made up of a top link and a bottom link that are securely connected together with gripper pins where a hexagonal hole is made in the bottom link and a tapered pin  29  is made in the top link such that the tapered pin press fits into the hex hole  32  and securely holds the top and bottom together. 
         [0061]    It may be necessary to heat stake the pin such that the pin is melted  29  into the hex hole to hold securely together as shown in  FIGS. 7 and 12 . The heat stake forming tool  33  is designed to provide the most heat transfer into the melted head of the boss  29  as shown in  FIG. 12 , and  FIG. 13   
         [0062]    A snap together fastener feature may alternately be used to hold these links together rather than the gripper pin design. 
         [0063]      FIG. 11 , The outside diameter of the gripper pin feature  81  is also used as a pivot pin for the link connectors as shown in  FIG. 15 . 
         [0064]      FIG. 14 , The Link connector assembly is made up of a top link  7 , and an elastomer link  20 , and bottom link  7  on the bottom. This assembly is assembled over the pivot pin boss  81 . The pivot pin boss  81  is symmetrical on each end of the link components  23 , 24 . 
         [0065]    The Link Components  23 , 24  can be injection molded in colors, The colors can be used to identify the proximal  58 , center  55 , and distal  62  sections of the Implantable Coil. 
         [0066]    The Link components can also be individually numbered starting with the first being the distal most tip. And the second link and so on. 
         [0067]    The Implantable Coil  104  further includes Radiopaque features that can be identified with Fluoroscopy Where the distal tip  7  of the Implantable coil  FIG. 3  is made up of two stainless steel spacers  78  that can easily be identified with a fluoroscope. The proximal tip  10  of the Implantable coil  FIG. 5  is made up of only one stainless steel spacers  24  that can easily be identified with a fluoroscope. This spacer  24  differs from the distal spacers  78  in that spacer  24  has scallops cut in the outer diameter that differentiate it from the distal end  7  while viewing with Fluoroscopy. The proximal tip  10  has a plastic spacer  39  that is not visible under Fluoroscopy. This combination of spacers provides a clear difference in the distal  7  and proximal  10  ends under Fluoroscopy. 
         [0068]      FIG. 8  The link joint can only bend to a pre-determined angle. This angle is determined by measuring in a pre-clinical environment, the minimum diameter that will pass from a hollow body organ into an adjoining lumen. Such as from the stomach into the pylorus. Once this diameter is determined, the device maximum angle was determined. The link connectors are designed to never bend beyond or smaller than this radius. 
         [0069]    Bending of the Implantable Coil  104  in all directions is necessary as the coil must be able to pass down through the over tube. The over tube  3  makes some turns down through the mouth and into the esophagus  4  as shown in  FIG. 1 . The Coil is designed to flex easily in the direction as the coil bends around the pivot pins but in the perpendicular direction the tolerances of the parts must allow the link assembly to flex to get around these anatomical curves. To be flexible in this direction the total height of the Link connector assembly as shown in  FIG. 14 . must be smaller than the 
         [0070]      FIG. 16  The link component&#39;s  23 ,  24  has flat&#39;s  40  on each end. The Elastoner Link Connector  20  pulls the links  23 ,  24  together and causes these flat surfaces to come together. This has a self straightening effect on the assembly. 
         [0071]    The Link connectors  FIG. 15  are also designed with an elastomer link connector  20 , the elastomer link connector  20  pulls the links  23 , 24  together end to end  40  and allows the entire Implantable Coil to exert outward pressure on the hollow body organ  FIG. 55 . This is accomplished by allowing the elastomer link connector  20  to flex/stretch which then allows the link to bend as shown in  FIG. 8 . The rigid link connectors  7  have an oval hole  79  that acts as a positive stop at the pre-determined bending radius as shown in  FIG. 8 . The link component  23 ,  24  are bent into this configuration with a pull cable  11 ,  18 . The positive stop bent configuration has several points that bottom out and prevent over bending of the link at  29 ,  42 , and  80  as shown in  FIG. 8 . In this configuration  FIG. 8  the Elastomer Link Connector  20  is stretched to its maximum length.  FIG. 15 , Note that the Elastomer Link Connector  20  must be stretched over the pivot pin boss  81  in order to be in a stretched position and to hold the flats  40  together as shown in  FIG. 16 . 
         [0072]    The Link Connectors  7  provide a gap filling feature between the Link sections, as shown in  FIG. 8  Item  20  or in the straight configuration  FIG. 16  Item  41  This overlap of components prevents tissue from getting between the Links,  23 ,  24   
         [0073]      FIG. 3  A String lock Link  8 ,  9  provides a locking means to allow the distal and proximal ends to be pulled into a curved diameter  105  as these curved ends will not allow passage of the Implantable Coil out of the hollow body organ into adjoining lumens such as the pylorus  6  as shown in  FIG. 2 . see Also  FIG. 52 . The string lock link assembly is made up by a simple modification to the regular link components  23 ,  24 . After hole&#39;s  64 ,  66 ,  106  are drilled through an existing parts  23 ,  24  they provide mounting for the string lock components. The new modified links are numbered in  FIG. 41  as  69 , and  70 . The Link component  24  or now  70  with the male pin  29  also has a modification to the rib  30  on both sides. One side rib gets a small arc  108  milled out as shown in  FIG. 41 . The other rib  71  gets a portion of the rib milled off as shown in  FIG. 42 . The main string lock components are the string lock  65 , and the string lock pin  107 . Both components are made from Biocompatible materials. They may be made from a variety of materials including: 316 Stainless Steel or suitable alternates. 
         [0074]      FIG. 43  The String Lock has a flexible arm  100  that is made from a single piece of Stainless Steel, A slot  99  is provided around the perimeter of the Flexible arm  100  to allow the arm to move as the string lock knot  19 ,  59  are pulled through during deployment. The arm flex&#39;s in area  77  while the post  73  are securely assembled in the holes  64 , and  106  between the Modified Link Components  69  and  70 . There are two slots  74  that provide free passage of the string lock cable  11 ,  18 . Additional space  75  is provided in the tip area  76  of the flexible arm  100  for the knot  19  and  59  to snap over and lock into place holding the distal and proximal ends of the Implantable Coil into a curved diameter  105  as shown in  FIGS. 44 ,  45 , and  52 . 
         [0075]      FIG. 3  Both ends of the Implantable Coil contain a loop of Removable pull cable  15  on the distal end and  13  on the proximal end. These pull cables consist of a long loop of cable connected at the ends with a Pull Link  16  at the distal end and  14  at the proximal end. The loop also is routed through a loop  17  distal and  12  proximal at the end of the string lock cables  18  distal and  11  proximal. After deployment is completed and the Implantable Coil is deployed as shown in  FIG. 35  the Removable pull cable  15  on the distal end and  13  on the proximal can be cut near the Pull Link  16 , and  14 . One end of each cut loop can be pulled to remove the Removable pull cable  13 , and  15  from the Implantable Coil assembly. 
         [0076]      FIG. 46  Deployment of the over tube  3  in the esophagus  4 , inspect and assess the interior surfaces of the Stomach  5  with the endoscope  60  The preferred embodiment of the Implantable Coil  104  is to deploy it in the gastric cavity or stomach  5 . The endoscope  60  is first advanced into the gastric cavity  5  to inspect and to orientate where the Implantable Coil  104  is to be placed. A guide wire may be used if necessary to re-insert the endoscope  60  with the over tube  3 . 
         [0077]      FIG. 47  Deployment of the distal portion of the Implantable Coil. Once the over tube  3  is placed as shown in  FIG. 46  the Endoscope  60  is removed and the Implantable Coil  104  is inserted down the over tube  3 . The Endoscope  60  is used to push the Implantable Coil  104  down the over tube  3  with a grasper through the working channel of the Endoscope  60 . The grasper holds onto the Proximal tip  10  of the Implantable Coil  104 . This assembly is then inserted down the over tube  3  First the distal tip  52  is ejected out the over tube tip inside the stomach as shown in  FIG. 47 . The Distal tip  53  continues its gentle deployment into the stomach as shown in  FIG. 22 . After 3 or 4 distal links are entered into the stomach, the distal pull cable  15  is pulled on from outside the body. The resultant distal cable  18  is pulled taunt  54  as shown in  FIG. 23 . As more Links  50  are gently advanced into the stomach the distal cable  18  continues to be pulled taunt  54  until the knot  19  is pulled inside the distal string lock link  8 . 
         [0078]      FIG. 48  Deployment of the distal portion of the Implantable Coil and Forming the distal portion of the coil into an arc The Knot  19  pulls through slot  74  and deflects flex arm  100  out of the path as the knot  19  is pulled through and locks on the other side of the flex arm  100  as shown in  FIGS. 43 ,  44 , and  45   
         [0079]      FIG. 49  Pull the distal pull cable  15  and lock the Distal string knot  19  into the distal string lock  8  Once locked in position the center coil section  55  continues to gently advance. The Distal Pull Cable  18  and  15  can be pulled while advancing to help make sure the distal tip deploys as needed in the gastric cavity. 
         [0080]      FIG. 50  Advance the Center Links  55  into the stomach  5  Once locked in position the center coil section  55  continues to gently advance. The Distal Pull Cable  18  and  15  can be pulled to help make sure the distal tip moves in the gastric cavity as needed. 
         [0081]      FIG. 51  Advance the Proximal Links  58  into the stomach  5  and pull on the proximal pull cable  13  and lock the Proximal string knot  59  into the Proximal string lock  9  The Proximal End  58  continues advancing into the gastric cavity  5 . First the Proximal Links  58  are advanced while gently pulling on the Proximal Pull Cable  11 , and  13 . This brings the proximal Links  58  into the gastric cavity  5  in a arc where the links push outward along the greater curve. This allows all of the Proximal Links  58  to be deployed inside the stomach  5 . The Proximal Pull Cable  11 , and  13  are then pulled to lock the Proximal String Lock  9  which temporarily pulls the links away from the greater curve of the stomach as shown in  FIG. 34 . 
         [0082]      FIG. 52  Inspect placement of the Implantable Coil  104  with endoscope  60  The final step prior to cutting the Pull Cable  11 , and  13  is to release the graspers that were used to hold the proximal tip  10 . The graspers are used through the Endoscope working channel to hold the proximal tip  10  to advance it down the over tube  3 . To remove the removable portion of the pull cable  13 , and  15  a pair of scissors  63  are used to cut the cables near the pull block  14 , and  16  as shown in  FIGS. 36 , and  38 . A final inspection can be done with the Endoscope  60  after the removal of the removable pull cables  13  and  15  as shown in  FIG. 39 . 
         [0083]      FIG. 53  Remove the Removable Pull Cables  13 ,  15 , Remove the Over Tube  3 , and Endoscope  60   
         [0084]      FIG. 54  This figure shows what a stomach looks like from both a side and front view before the Implantable Coil  104  is implanted. 
         [0085]      FIG. 55  This figure is the same as  FIG. 54  except that the Implantable Coil  104  is implanted and the stomach is distended in the front plane where it brings the anterior and posterior surfaces together.