Apparatus and methods for treatment of morbid obesity

Abstract

Apparatus and methods are described for treatment of morbid obesity using minimally invasive techniques. The apparatus includes a system of components that may be used separately or in combination for effectively reducing stomach volume, bypassing a portion of the stomach and/or small intestines, reducing nutrient absorption in the stomach and/or small intestines and/or depositing minimally or undigested food farther than normal into the intestines, thereby stimulating intestinal responses. The components described include an artificial stoma device, a gastric sleeve device, an intestinal sleeve device, a combined gastrointestinal sleeve device and permanent and detachable attachment systems. Also described are devices for delivering and deploying the components of the system.

1 . A method of treating a patient, comprising the steps of: 
 providing an elongate tubular body, having a proximal end, a distal end, and a flow restrictor; and    positioning the tubular body in the patient such that the distal end is in the intestine, and the flow restrictor is in the stomach, spaced apart from the pylorus.    
   
   
       2 . A method of treating a patient as in  claim 1 , wherein the flow restrictor comprises a narrowing in the tubular body.  
   
   
       3 . A method of treating a patient as in  claim 1 , wherein the flow restrictor comprises an orifice.  
   
   
       4 . A method of treating a patient as in  claim 1 , wherein the flow restrictor is adjustable.  
   
   
       5 . A method of treating a patient as in  claim 1 , wherein at least a portion of the tubular body is releasably coupled to the flow restrictor.  
   
   
       6 . A method of treating a patient as in  claim 1 , further comprising the step of attaching the tubular body to the wall of the stomach.  
   
   
       7 . A method of treating as in  claim 6 , wherein the attaching step comprises using a suture.  
   
   
       8 . A method of treating a patient as in  claim 7 , wherein the attaching step comprises suturing the tubular body to the wall of the stomach.  
   
   
       9 . A method of treating a patient as in  claim 7 , wherein the attaching step comprises attaching the tubular body to a tissue anchor with the suture.  
   
   
       10 . A method of treating a patient, comprising the steps of: 
 establishing a flow restriction within the stomach, in between the LES and pylorus; and    positioning a tube between the flow restriction and the intestine.    
   
   
       11 . A method of treating a patient as in  claim 10 , wherein the positioning step comprises positioning the tube such that it extends from the flow restriction and into the intestine at least as far as the ligament of Treitz.  
   
   
       12 . A method of treating a patient as in  claim 10 , wherein the establishing a flow restriction step comprises inserting a prosthetic stoma.  
   
   
       13 . A method of treating a patient as in  claim 10 , wherein the establishing a flow restriction step comprises creating a stoma from adjacent tissue.  
   
   
       14 . A method of treating a patient, comprising the steps of: 
 providing a tube, having a proximal end, a distal end and a lumen extending therethrough;    positioning the proximal end in the stomach and the distal end in the intestine; and    preventing gastric juices expressed from the wall of the stomach distally of the proximal end from entering the lumen.    
   
   
       15 . A method of treating a patient as in  claim 14 , wherein the positioning step comprises positioning the distal end in the jejunum.  
   
   
       16 . An endolumenal bypass method for treating obesity in a mammal, comprising the steps of: 
 establishing a pseudo stomach within the mammal, having a restricted distal opening;    establishing a flow path between the restricted opening and a point in the intestine distal to the duodenum.    
   
   
       17 . An endolumenal bypass method as in  claim 16 , wherein the establishing a flow path step comprises deploying a tubular sleeve within the intestine.  
   
   
       18 . An endolumenal bypass method as in  claim 16 , wherein the establishing a flow path step comprises securing opposing tissue surfaces together.  
   
   
       19 . An upper gastrointestinal implant, comprising: 
 an elongate, tubular body, having a proximal end and a distal end;    a funnel opening on the proximal end; and    a support structure, spaced distally apart from the proximal end;    wherein the implant is dimensioned such that the proximal end is positioned in between the antrum and the lower esophageal sphincter when the support structure is positioned in the antrum.    
   
   
       20 . An upper gastrointestinal implant as in  claim 19 , wherein the support structure comprises a self expandable ring.  
   
   
       21 . An upper gastrointestinal implant as in  claim 19 , wherein the support structure comprises a longitudinally oriented stiffening member.  
   
   
       22 . An upper gastrointestinal implant as in  claim 19  further comprising an intestinal extension.  
   
   
       23 . An upper gastrointestinal implant as in  claim 22 , wherein the column strength of the implant is greater in between the support structure and the proximal end than it is in the intestinal extension.  
   
   
       24 . A method of treating a patient, comprising the steps of: 
 providing an elongate tubular body, having a proximal end and a distal end:    positioning the tubular body such that the proximal end is within the stomach and the distal end is in the intestine; and    retaining the tubular body in position by engaging an anchor on the tubular body with adjacent tissue;    wherein the anchor is spaced distally apart from the proximal end of the tubular body.    
   
   
       25 . A method of treating a patient as in  claim 24 , wherein the providing step comprises providing a tubular body having a flow restrictor.  
   
   
       26 . A method of treating a patient as in  claim 25 , wherein the flow restrictor comprises a narrowing in the tubular body.  
   
   
       27 . A method of treating a patient as in  claim 25 , wherein the flow restrictor comprises an orifice.  
   
   
       28 . A method of treating a patient as in  claim 25 , wherein the flow restrictor is adjustable.  
   
   
       29 . A method of treating a patient as in  claim 25 , wherein at least a portion of the tubular body is releasably coupled to the flow restrictor.  
   
   
       30 . A method of treating a patient as in  claim 25 , further comprising the step of attaching the tubular body to the wall of the stomach.  
   
   
       31 . A method of treating as in  claim 30 , wherein the attaching step comprises using a suture.  
   
   
       32 . A method of treating a patient as in  claim 31 , wherein the attaching step comprises suturing the tubular body to the wall of the stomach.  
   
   
       33 . A method of treating a patient as in  claim 31 , wherein the attaching step comprises attaching the tubular body to a tissue anchor with the suture.  
   
   
       34 . A method of treating a patient as in  claim 24 , wherein the retaining step comprises engaging the anchor within the antrum.  
   
   
       35 . A method of treating a patient as in  claim 24 , wherein the retaining step comprises engaging the anchor within the pylorus.  
   
   
       36 . A method of transesophageally deploying a tubular implant within a patient, comprising the steps of: 
 providing a tubular implant, having a proximal end, a distal end, and a central lumen; the distal end initially positioned within the central lumen such that the distal most aspect of the implant is initially an intermediate portion of the implant;    transesophageally advancing the implant, intermediate portion first, through the stomach at least as far as the antrum; and    everting the distal end of the implant from the central lumen and into the intestine.    
   
   
       37 . A method of increasing the effective length of an endolumenal intestinal bypass, comprising the steps of: 
 positioning an endolumenal bypass tube within an intestine such that a distal end of the bypass tube is initially positioned at a first point in the intestine;    anchoring the tube against distal migration with respect to the stomach; and    permitting peristalsis to draw the intestine proximally with respect to the tube, thereby locating the distal end at a position within the intestine which is distal to the first point.    
   
   
       38 . A method of positioning a tubular implant within an intestine of a patient, comprising the steps of: 
 providing an elongate, tubular body, having a proximal end, a distal end, and a first magnet secured to the distal end;    transesophageally introducing the distal end into the stomach;    advancing the distal end into the pylorus; and    advancing the distal end from the pylorus into the intestine;    wherein at least the advancing the distal end from the pylorus into the intestine step is accomplished using a second magnet, external to the patient.    
   
   
       39 . A method of treating a patient, comprising the steps of: 
 providing a gastrointestinal sleeve, having a proximal end, a distal end and a length of at least about 50 cm;    positioning the sleeve with the proximal end adjacent an attachment site in the vicinity of the lower esophageal sphincter, with the distal end extending transluminally at least as far as the jejunum;    forming at least one plication at the attachment site; and    securing the sleeve to the plication.    
   
   
       40 . A method of treating a patient as in  claim 39 , comprising the step of forming at least three plications and securing the sleeve to the plications.  
   
   
       41 . A method of treating a patient as in  claim 39 , comprising the step of extending the distal end into the intestine at least as far as the ligament of Treitz.  
   
   
       42 . A method of treating a patient as in  claim 39 , wherein the providing step comprises providing a sleeve having a substantially constant diameter throughout its length.