Devices and methods for treatment of obesity

Abstract

Methods, devices, tools, instruments and systems for treating a patient to induce weight loss. In one method embodiment, a device, including an expandable member in a collapsed configuration, is passed through an opening in the skin of the patient, and into the abdominal cavity of the patient. At least a portion of the expandable member is anchored relative to at least one structure in the abdominal cavity, without piercing the stomach. The expandable member is expanded to an expanded configuration in a space in the abdominal cavity to perform at least one of: prevention of expansion of the stomach of the patient into the space; and compression of a portion of the stomach.

1 . A method of treating a patient, said method comprising: 
 passing a device including an expandable member in a collapsed configuration through an opening in the skin of the patient, and into the abdominal cavity of the patient;    anchoring at least a portion of the expandable member, relative to at least one structure in the abdominal cavity, without piercing the stomach; and    expanding the expandable member to an expanded configuration in a space in the abdominal cavity to perform at least one of: prevention of expansion of the stomach of the patient into the space; and compression of a portion of the stomach.    
   
   
       2 . The method of  claim 1 , wherein said method is performed as a percutaneous procedure.  
   
   
       3 . The method of  claim 1 , wherein said method is performed as a laparoscopic procedure.  
   
   
       4 . The method of  claim 1 , wherein said method is performed as a mini-laparoscopic procedure.  
   
   
       5 . The method of  claim 1 , wherein a guidewire is passed through the skin of the patient, and into the abdominal cavity, and wherein the device is passed over the guidewire to guide the device to an intended location in the abdominal cavity.  
   
   
       6 . The method of  claim 1 , further comprising inserting a sheath through a minimally invasive opening made through the skin and the abdominal wall, wherein the guidewire is inserted through the sheath to pass the guidewire through the skin and abdominal wall and into the abdominal cavity.  
   
   
       7 . The method of  claim 5 , further comprising inserting a flexible endoscope through the skin and into the abdominal cavity, to view placement of the guidewire prior to passing the device over the guidewire.  
   
   
       8 . The method of  claim 5 , further comprising visualizing placement of the guidewire using at least one of: fluoroscopy, three-dimensional RF visualization, and three-dimensional magnetic visualization.  
   
   
       9 . The method of  claim 5 , further comprising inserting a trocar through the sheath and advancing the trocar to establish a pathway into the abdominal cavity.  
   
   
       10 . The method of  claim 1 , further comprising advancing an anchoring frame through the skin and into the abdominal cavity, prior to said passing a device including an expandable member through the skin of the patient, and into the abdominal cavity of the patient; and anchoring the expandable member to the anchoring frame upon passing the device into the abdominal cavity.  
   
   
       11 . The method of  claim 10 , wherein said anchoring frame is an elongated anchoring frame.  
   
   
       12 . The method of  claim 10 , wherein the anchoring frame is anchored to a structure in the abdominal cavity prior to anchoring the expandable member to the anchoring frame.  
   
   
       13 . The method of  claim 10 , wherein the anchoring frame is anchored to a structure in the abdominal cavity by action of passing the device over the anchoring frame.  
   
   
       14 . The method of  claim 12 , wherein the anchoring frame is anchored to an internal surface of the abdominal wall.  
   
   
       15 . The method of  claim 13 , wherein the anchoring frame is anchored to an internal surface of the abdominal wall.  
   
   
       16 . The method of  claim 10 , wherein the expandable member of the device is locked to the anchoring frame by a mechanical locking apparatus.  
   
   
       17 . The method of  claim 5 , further comprising advancing an anchoring frame over the guidewire,) through the skin and into the abdominal cavity, prior to said passing a device over the guidewire; and anchoring the expandable member to the anchoring frame upon passing the device into the abdominal cavity.  
   
   
       18 . The method of  claim 17 , wherein said anchoring frame is an elongated anchoring frame.  
   
   
       19 . The method of  claim 17 , wherein the anchoring frame is anchored to a structure in the abdominal cavity prior to anchoring the expandable member to the anchoring frame.  
   
   
       20 . The method of  claim 17 , wherein the anchoring frame is anchored to a structure in the abdominal cavity by action of passing the device over the anchoring frame.  
   
   
       22 . The method of  claim 19 , wherein the anchoring frame is anchored to an internal surface of the abdominal wall.  
   
   
       23 . The method of  claim 20 , wherein the anchoring frame is anchored to an internal surface of the abdominal wall.  
   
   
       24 . The method of  claim 17 , wherein the expandable member of the device is locked to the anchoring frame by a mechanical locking apparatus.  
   
   
       25 . The method of  claim 1 , wherein said expandable member is inflatable, said method further comprising attaching an access member external of the abdominal wall, said access member in fluid communication with said expandable member.  
   
   
       26 . The method of  claim 1 , wherein said device further comprises a second expandable member, said method further comprising at least partially expanding the second expandable member.  
   
   
       27 . The method of  claim 1 , wherein the device is passed in a compact configuration, the device being provided with looped tabs, the compact configuration being achieved by rolling the device to align opposite sets of the looped tabs, and inserting a rod or wire through the aligned sets of looped tabs.  
   
   
       28 . The method of  claim 1 , wherein the device is passed in a compact configuration, the compact configuration being achieved by providing an expandable compaction member that is preformed to roll up when inflated; placing the expandable member on the expandable compaction member while said compaction member is in a spread apart, non-inflated state; and inflating said expandable compaction member to assume a rolled up configuration substantially surrounding the expandable member and maintaining the expandable member in the compact configuration.  
   
   
       29 . The method of  claim 28 , further comprising deflating the expandable compaction member once the expandable member has been positioned in a desired location in the abdominal cavity; and retracting the deflated compaction member to remove it form the expandable member prior to said expanding the expandable member.  
   
   
       30 . The method of  claim 29 , wherein said anchoring comprises anchoring the expandable member via at least one of: at least one attachment tab, an attachment flange, and an anchoring rail prior to said deflating the expandable compaction member.  
   
   
       31 . The method of  claim 29 , wherein said anchoring at least a portion of the expandable member is performed prior to said deflating the expandable compaction member.  
   
   
       32 . The method of  claim 1 , wherein the device is passed in a compact configuration, the compact configuration being achieved by providing a rigid exoskeleton; and placing the expandable member in the rigid exoskeleton, wherein the rigid exoskeleton maintains the expandable member in the compact configuration.  
   
   
       33 . The method of  claim 32 , further comprising extracting the expandable member from the rigid exoskeleton once the expandable member has been positioned in a desired location in the abdominal cavity.  
   
   
       34 . The method of  claim 33 , wherein a distal portion of the expandable member, at least one attachment tab or flange extending from a distal portion of the expandable member, or a distal portion of the expandable member and at least one attachment tab or flange extending from the expandable member extends out of the rigid exoskeleton prior to said extracting, and wherein said anchoring at least a portion of the expandable member is performed prior to said extracting and assists in said extracting by retracting the rigid exoskeleton against the force provided by said anchoring.  
   
   
       35 . The method of  claim 33 , wherein said extracting comprises rotating the rigid exoskeleton.  
   
   
       36 . The method of  claim 33 , wherein said extracting comprises moving the rigid exoskeleton linearly away from an anchored portion of the expandable member.  
   
   
       37 . The method of  claim 34 , wherein said anchoring comprises anchoring via at least one of: the at least one attachment tab, an attachment flange, and an anchoring rail.  
   
   
       38 . The method of  claim 33 , wherein said extracting is performed incrementally, said method further comprising anchoring additional portions of the expandable member in steps between incremental extraction steps performed.  
   
   
       39 . (canceled)  
   
   
       40 . The method of  claim 1 , wherein the device is passed in a compact configuration, the compact configuration being achieved by providing a capsule formed of a water soluble skin; inserting the expandable member, while in a compact configuration into the capsule; and maintaining the compact configuration of the expandable member with the capsule during said passing a device.  
   
   
       41 . The method of  claim 40 , wherein the water soluble skin of the capsule at least partially dissolves in the space prior to said expanding the expandable member.  
   
   
       42 . The method of  claim 1 , wherein the device is passed in a compact configuration, the compact configuration being achieved by insertion the expandable member in an expandable exoskeleton, wherein the expandable exoskeleton has a first configuration that maintains the expandable member in the compact configuration, and a second, expanded configuration, wherein the second, expanded configuration is achieved by said expanding the expandable member.  
   
   
       43 . The method of  claim 1 , wherein the expandable member comprises an elongated tube, said anchoring at least a portion of the expandable member comprises anchoring a distal end portion of the tube, said method further comprising incrementally advancing an additional portion of the tube and placing the additional portion into a desired location; anchoring the additional portion; and repeating the incrementally advancing, placing and anchoring the additional portion steps until all of the elongated tube has been placed and anchored in the abdominal cavity.  
   
   
       44 . The method of  claim 1 , wherein the device is passed in a compact configuration, the compact configuration being achieved and maintained by compacting the expandable member and inserting the expandable member within a sheath.  
   
   
       45 . The method of  claim 10 , wherein the device is passed in a compact configuration, the compact configuration being achieved and maintained by compacting the expandable member and inserting the expandable member within a sheath.  
   
   
       46 . The method of  claim 1 , wherein the device is passed in a compact configuration via an introducer that maintains the device in the compact configuration during said passing.  
   
   
       47 . (canceled)  
   
   
       48 . The method of  claim 46 , wherein said anchoring is performed prior to said opening.  
   
   
       49 . The method of  claim 46 , wherein said anchoring is performed after said opening.  
   
   
       50 . The method of  claim 46 , wherein said opening is performed by manipulation of one or more tethers extending though the introducer.  
   
   
       51 . The method of  claim 50 , wherein the device is reoriented relative to the introducer by action of said opening, facilitated by the at least one tether.  
   
   
       52 . The method of  claim 46 , further comprising extracting the expandable member after said opening.  
   
   
       53 . The method of  claim 51 , further comprising extracting the expandable member after the device is reoriented.  
   
   
       54 . (canceled)  
   
   
       55 . The method of  claim 46 , wherein said anchoring comprises anchoring via at least one of: at least one attachment tab, an attachment flange, and an anchoring rail.  
   
   
       56 . The method of  claim 46 , further comprising extracting the expandable member incrementally, said method further comprising anchoring additional portions of the expandable member in steps between incremental extraction steps performed.  
   
   
       57 . (canceled)  
   
   
       58 . The method of  claim 46 , further comprising providing the expandable member in the compact configuration around a distal end portion of an inner sheath of the introducer, and sliding a distal end portion of an outer sheath of the introducer over at least a portion of the expandable member to maintain the expandable member in the compact configuration during said passing a device.  
   
   
       59 . The method of  claim 58 , further comprising retracting the outer sheath relative to the inner sheath, once the device has been placed in the space in the abdominal cavity, so that the outer sheath no longer covers the expandable member.  
   
   
       60 . (canceled)  
   
   
       61 . The method of  claim 59 , further comprising extracting the expandable member after said retracting.  
   
   
       62 . (canceled)  
   
   
       63 . The method of  claim 61 , wherein a distal portion of the expandable member, at least one attachment tab or flange extending from a distal portion of the expandable member, or a distal portion of the expandable member and at least one attachment tab or flange extending from the expandable member extends out of the compact configuration prior to said extracting, and wherein said anchoring at least a portion of the expandable member is performed prior to said extracting and assists in said extracting by retracting the introducer against the force provided by said anchoring.  
   
   
       64 . The method of  claim 63 , wherein said anchoring comprises anchoring via at least one of: the at least one attachment tab, an attachment flange, and an anchoring rail.  
   
   
       65 . The method of  claim 61 , wherein said extracting is performed incrementally, said method further comprising anchoring additional portions of the expandable member in steps between incremental extraction steps performed.  
   
   
       66 . The method of  claim 61 , wherein a distal portion of the expandable member, at least one attachment tab or flange extending from a distal portion of the expandable member, or a distal portion of the expandable member and at least one attachment tab or flange extending from the expandable member extends out of the compact configuration prior to said extracting, wherein said extracting is performed by grasping the distal portion of the expandable member, the at least one attachment tab or flange extending from a distal portion of the expandable member, or the distal portion of the expandable member and at least one attachment tab or flange extending from the expandable member and holding the same relatively motionless while retracting the introducer, and wherein said anchoring at least a portion of the expandable member is performed after said extracting.  
   
   
       67 . (canceled)  
   
   
       68 . (canceled)  
   
   
       69 . (canceled)  
   
   
       70 . The method of  claim 58 , wherein a distal portion of the expandable member, at least one attachment tab or flange extending from a distal portion of the expandable member, or a distal portion of the expandable member and at least one attachment tab or flange extending from the expandable member extends out of the compact configuration prior to said extracting, wherein said extracting is performed by grasping the distal portion of the expandable member, the at least one attachment tab or flange extending from a distal portion of the expandable member, or the distal portion of the expandable member and at least one attachment tab or flange extending from the expandable member and holding the same relatively motionless while retracting the introducer, and wherein said anchoring at least a portion of the expandable member is performed after said extracting.  
   
   
       71 . The method of  claim 46 , wherein the introducer comprises a rigid sheath and at least a portion of the expandable member is inserted, in the compact configuration, into the rigid sheath to maintain the expandable member in the compact configuration during said passing a device.  
   
   
       72 . The method of  claim 71 , further comprising tongue-rolling the expandable member into the compact configuration, prior to insertion into the rigid sheath.  
   
   
       73 . The method of  claim 71 , further comprising retracting the rigid sheath relative to the expandable member, once the device has been placed in the space in the abdominal cavity, so that the rigid sheath no longer covers the expandable member.  
   
   
       74 . The method of  claim 71 , wherein a distal end portion of the expandable member, at least one attachment tab or flange extending from a distal end portion of the expandable member, or a distal end portion of the expandable member and at least one attachment tab or flange extending from the expandable member extends out of the rigid sheath prior to said retracting the rigid sheath, and wherein said anchoring at least a portion of the expandable member is performed prior to said retracting and retains the expandable member relatively fixed as the rigid sheath is retracted.  
   
   
       75 . The method of  claim 74 , wherein said anchoring comprises anchoring via at least one of: the at least one attachment tab, an attachment flange, and an anchoring rail.  
   
   
       76 . The method of  claim 73 , wherein said retracting is performed incrementally, said method further comprising anchoring additional portions of the expandable member in steps between incremental retraction steps performed.  
   
   
       77 . The method of  claim 71 , wherein a distal end portion of the expandable member, at least one attachment tab or flange extending from the distal end portion of the expandable member, or the distal end portion of the expandable member and the at least one attachment tab or flange extending from the expandable member extends out of the rigid sheath prior to said retracting, wherein said retracting is performed by grasping the distal end portion of the expandable member, the at least one attachment tab or flange extending from the distal portion of the expandable member, or the distal end portion of the expandable member and the at least one attachment tab or flange extending from the expandable member and holding the same relatively motionless while retracting the rigid sheath, and wherein said anchoring at least a portion of the expandable member is performed after said retracting.  
   
   
       78 . The method of  claim 10 , wherein the expandable member is a first expandable member, said method further comprising adjusting expansion of a second expandable member to vary a degree of at least one of: prevention of expansion of the stomach of the patient into the space; and compression of a portion of the stomach.  
   
   
       79 . The method of  claim 10 , wherein at least one tab extends from the expandable member, said anchoring comprising fixing said at least one tab to said at least one structure.  
   
   
       80 . The method of  claim 10 , further comprising anchoring an adjustment member that is connected to the expandable member via a conduit, to a portion of the patient's body.  
   
   
       81 . The method of  claim 10 , further comprising: 
 passing an intragastric expandable device within the interior cavity of the stomach;    expanding the intragastric expandable device to a predetermined size or pressure;    expanding the expandable member to displace a portion of the stomach wall;    monitoring the expanding of the expandable member and displacement of the portion of the stomach wall; and    ceasing expanding the expandable member when the distance between the portion of the stomach wall being displaced and the intra-gastric expandable device reaches a predetermined distance or when a predetermined pressure is monitored via the intra-gastric expandable device.    
   
   
       82 . The method of  claim 81 , wherein said expanding is ceased when the stomach wall contacts the intragastric expandable device.  
   
   
       83 . The method of  claim 81 , wherein the intragastric expandable device comprises a pressure sensor and said expanding is ceased when pressure monitored by the pressure sensor reaches a predetermined pressure level.  
   
   
       84 . The method of  claim 81 , wherein the intragastric expandable device comprises an ultrasonic sensor configured to measure the distance between the portion of the wall being depressed and the intragastric expandable device, and said expanding is ceased when a predetermined distance has been reached.  
   
   
       85 . The method of  claim 81 , wherein said monitoring comprises visualization by a surgeon of the advancement of the displacement of the stomach wall toward the intragastric expandable device, and said expanding is ceased when a predetermined distance has been reached.  
   
   
       86 . The method of  claim 81 , wherein said expanding is ceased when it is confirmed through visualization that the wall has contacted the intragastric expandable device.  
   
   
       87 - 184 . (canceled)