WO2004050971A2 - Apparatus and method for manipulating tissue - Google Patents
Apparatus and method for manipulating tissue Download PDFInfo
- Publication number
- WO2004050971A2 WO2004050971A2 PCT/US2003/038110 US0338110W WO2004050971A2 WO 2004050971 A2 WO2004050971 A2 WO 2004050971A2 US 0338110 W US0338110 W US 0338110W WO 2004050971 A2 WO2004050971 A2 WO 2004050971A2
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- WIPO (PCT)
- Prior art keywords
- shaft
- tissue
- effector
- distal end
- mechanisms
- Prior art date
Links
- 238000000034 method Methods 0.000 title claims description 47
- 230000007246 mechanism Effects 0.000 claims abstract description 327
- 239000012636 effector Substances 0.000 claims abstract description 255
- 210000002784 stomach Anatomy 0.000 claims description 39
- 208000021302 gastroesophageal reflux disease Diseases 0.000 claims description 19
- 210000001015 abdomen Anatomy 0.000 claims description 3
- 210000003238 esophagus Anatomy 0.000 description 16
- 239000000463 material Substances 0.000 description 8
- 208000008589 Obesity Diseases 0.000 description 7
- 235000020824 obesity Nutrition 0.000 description 7
- 208000037265 diseases, disorders, signs and symptoms Diseases 0.000 description 6
- 239000003292 glue Substances 0.000 description 6
- 201000010099 disease Diseases 0.000 description 5
- 210000001035 gastrointestinal tract Anatomy 0.000 description 4
- 238000010992 reflux Methods 0.000 description 4
- 238000012800 visualization Methods 0.000 description 4
- 239000000853 adhesive Substances 0.000 description 3
- 230000001070 adhesive effect Effects 0.000 description 3
- 239000002253 acid Substances 0.000 description 2
- 230000009286 beneficial effect Effects 0.000 description 2
- 230000008901 benefit Effects 0.000 description 2
- 238000010276 construction Methods 0.000 description 2
- 230000000694 effects Effects 0.000 description 2
- 230000002496 gastric effect Effects 0.000 description 2
- 230000036541 health Effects 0.000 description 2
- 208000001022 morbid obesity Diseases 0.000 description 2
- 230000000087 stabilizing effect Effects 0.000 description 2
- 238000001356 surgical procedure Methods 0.000 description 2
- 208000023514 Barrett esophagus Diseases 0.000 description 1
- 208000023665 Barrett oesophagus Diseases 0.000 description 1
- 208000007217 Esophageal Stenosis Diseases 0.000 description 1
- 206010054949 Metaplasia Diseases 0.000 description 1
- 206010030194 Oesophageal stenosis Diseases 0.000 description 1
- 206010030201 Oesophageal ulcer Diseases 0.000 description 1
- 206010030216 Oesophagitis Diseases 0.000 description 1
- 210000000683 abdominal cavity Anatomy 0.000 description 1
- 230000009471 action Effects 0.000 description 1
- 230000007547 defect Effects 0.000 description 1
- 208000035475 disorder Diseases 0.000 description 1
- 239000003814 drug Substances 0.000 description 1
- 201000006549 dyspepsia Diseases 0.000 description 1
- 208000006881 esophagitis Diseases 0.000 description 1
- 210000003236 esophagogastric junction Anatomy 0.000 description 1
- 210000003736 gastrointestinal content Anatomy 0.000 description 1
- 208000024798 heartburn Diseases 0.000 description 1
- 230000015689 metaplastic ossification Effects 0.000 description 1
- 238000012986 modification Methods 0.000 description 1
- 230000004048 modification Effects 0.000 description 1
- 210000000056 organ Anatomy 0.000 description 1
- 239000000523 sample Substances 0.000 description 1
- 239000007787 solid Substances 0.000 description 1
- 210000005070 sphincter Anatomy 0.000 description 1
- 208000024891 symptom Diseases 0.000 description 1
- 208000011580 syndromic disease Diseases 0.000 description 1
- 230000001225 therapeutic effect Effects 0.000 description 1
- 238000002560 therapeutic procedure Methods 0.000 description 1
- 238000002604 ultrasonography Methods 0.000 description 1
- 230000000007 visual effect Effects 0.000 description 1
Classifications
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
- A61B17/00—Surgical instruments, devices or methods, e.g. tourniquets
- A61B17/068—Surgical staplers, e.g. containing multiple staples or clamps
- A61B17/072—Surgical staplers, e.g. containing multiple staples or clamps for applying a row of staples in a single action, e.g. the staples being applied simultaneously
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
- A61B17/00—Surgical instruments, devices or methods, e.g. tourniquets
- A61B17/00234—Surgical instruments, devices or methods, e.g. tourniquets for minimally invasive surgery
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
- A61B17/00—Surgical instruments, devices or methods, e.g. tourniquets
- A61B17/02—Surgical instruments, devices or methods, e.g. tourniquets for holding wounds open; Tractors
- A61B17/0218—Surgical instruments, devices or methods, e.g. tourniquets for holding wounds open; Tractors for minimally invasive surgery
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
- A61B17/00—Surgical instruments, devices or methods, e.g. tourniquets
- A61B17/068—Surgical staplers, e.g. containing multiple staples or clamps
- A61B17/072—Surgical staplers, e.g. containing multiple staples or clamps for applying a row of staples in a single action, e.g. the staples being applied simultaneously
- A61B17/07292—Reinforcements for staple line, e.g. pledgets
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
- A61B17/00—Surgical instruments, devices or methods, e.g. tourniquets
- A61B17/00234—Surgical instruments, devices or methods, e.g. tourniquets for minimally invasive surgery
- A61B2017/00349—Needle-like instruments having hook or barb-like gripping means, e.g. for grasping suture or tissue
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
- A61B17/00—Surgical instruments, devices or methods, e.g. tourniquets
- A61B2017/00743—Type of operation; Specification of treatment sites
- A61B2017/00818—Treatment of the gastro-intestinal system
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
- A61B17/00—Surgical instruments, devices or methods, e.g. tourniquets
- A61B2017/00743—Type of operation; Specification of treatment sites
- A61B2017/00818—Treatment of the gastro-intestinal system
- A61B2017/00827—Treatment of gastro-esophageal reflux
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
- A61B17/00—Surgical instruments, devices or methods, e.g. tourniquets
- A61B2017/00831—Material properties
- A61B2017/00876—Material properties magnetic
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
- A61B17/00—Surgical instruments, devices or methods, e.g. tourniquets
- A61B17/068—Surgical staplers, e.g. containing multiple staples or clamps
- A61B17/072—Surgical staplers, e.g. containing multiple staples or clamps for applying a row of staples in a single action, e.g. the staples being applied simultaneously
- A61B2017/07214—Stapler heads
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
- A61B17/00—Surgical instruments, devices or methods, e.g. tourniquets
- A61B17/28—Surgical forceps
- A61B17/29—Forceps for use in minimally invasive surgery
- A61B2017/2901—Details of shaft
- A61B2017/2905—Details of shaft flexible
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
- A61B17/00—Surgical instruments, devices or methods, e.g. tourniquets
- A61B17/30—Surgical pincettes without pivotal connections
- A61B2017/306—Surgical pincettes without pivotal connections holding by means of suction
Definitions
- This invention relates to medical apparatus and methods in general, and more particularly to medical apparatus and methods for manipulating tissue.
- Gastroesophageal reflux disease is the most common gastrointestinal problem in humans. GERD occurs when the esophageal exposure to acid from the stomach is greater than that of the normal population. GERD may be a result from a defect in the stomach, the esophageal sphincter, or the esophagus. Heartburn is the most common symptom. GERD can result in complications such as esophagitis, esophageal ulceration, esophageal stricture, esophageal metaplasia (i.e., Barrett's esophagus) and short esophagus syndrome.
- GERD Gastroesophageal reflux disease
- One possible way to treat GERD may be to alter the configuration of the esophagus and/or stomach.
- Obesity is associated with a large number of health-related problems. Several of these problems are underlying causes of earlier mortality for obesity. Obesity may be treated with mechanical interventions including surgical procedures .
- One possible way to treat obesity may be to manipulate the tissues of the gastrointestinal tract to alter the size and/or shape of the stomach.
- Still other medical disorders may be treated by manipulating tissue in selected ways, e.g., such as by bringing opposite walls of a tube of tissue into proximity with one another, or for creating a cylinder or tube of tissue wrapped partially or entirely by an outer layer of tissue, etc.
- an apparatus for reconfiguring tissue comprising: a shaft having a distal end and a proximal end; at least one effector mechanism movably mounted to said distal end of said shaft, each said effector mechanism comprising at least one gripping element for gripping tissue to that effector mechanism, said at least one effector mechanism being configured to capture the gripped tissue against said shaft; at least one actuating mechanism mounted to said proximal end of said shaft; and at least one connection mechanism connecting said at least one actuating mechanism to said at least one effector mechanism, whereby a user may utilize said at least one actuating mechanism to actuate said at least one effector mechanism so as to reconfigure tissue.
- an apparatus for reconfiguring tissue comprising: a shaft having a distal end and a proximal end, wherein said distal end of said shaft comprises at least one gripping element for drawing tissue against said shaft and for selectively maintaining the tissue in such engagement; two effector mechanisms movably mounted to said distal end of said shaft, each said effector mechanism comprising at least one gripping element for gripping tissue to that effector mechanism, said two effector mechanisms being configured to capture the gripped tissue against said shaft, wherein said distal end of said shaft comprises a longitudinal axis, wherein said two effector mechanisms are pivotally mounted to said shaft along a pivot axis extending parallel to said longitudinal axis of said distal end of said shaft, wherein said two effector mechanisms are configured to move between (i) a closed position wherein said two effector mechanisms fold concentrically about said distal end of said shaft, and (ii) an open position wherein said two effector mechanisms rise like wings over said shaft, and wherein said at least one grip
- an apparatus for reconfiguring tissue comprising: a shaft having a distal end and a proximal end, wherein said distal end of said shaft comprises at least one gripping element for drawing tissue against said shaft and for maintaining the tissue in such engagement while suction is maintained; an effector mechanism movably mounted to said distal end of said shaft, said effector mechanism comprising at least one gripping element for gripping tissue to that effector mechanism, said effector mechanism being configured to capture the gripped tissue against said shaft, wherein said distal end of said shaft comprises a longitudinal axis, wherein said effector mechanism is pivotally mounted to said shaft along a pivot axis extending transverse to said longitudinal axis of said distal end of said shaft, wherein said effector mechanism is configured to move between (i) a closed position wherein said effector mechanism folds concentrically about said distal end of said shaft, and (ii) an open position wherein said effector mechanism rises over said shaft, and wherein said at least one griping element
- an apparatus for reconfiguring tissue comprising: a shaft having a distal end and a proximal end; a plurality of effector mechanisms mounted to said distal end of said shaft, each said effector mechanism comprising at least one gripping element for gripping tissue to that effector mechanism, said plurality of effector mechanisms being configured to capture the gripped tissue against said shaft, wherein said distal end of said shaft comprises a longitudinal axis, wherein said plurality of effector mechanisms extend parallel to said longitudinal axis of said distal end of said shaft, wherein said plurality of effector mechanisms are configured to move between (i) a first position wherein said plurality of effector mechanisms collectively form a tubular configuration, and (ii) a second position wherein said plurality of effector mechanisms collectively form a non- tubular configuration, and wherein said at least one gripping element comprises a suction pod for drawing tissue against the effector mechanism and for maintaining the tissue in such engagement while suction is maintained; at least one actuating
- a method for reconfiguring tissue comprising: providing apparatus comprising: a shaft having a distal end and a proximal end, wherein said distal end of said shaft comprises at least one gripping element for drawing tissue against said shaft and for selectively maintaining the tissue in such engagement; two effector mechanisms movably mounted to said distal end of said shaft, each said effector mechanism comprising at least one gripping element for gripping tissue to that effector mechanism, said two effector mechanisms being configured to capture the gripped tissue against said shaft, wherein said distal end of said shaft comprises a longitudinal axis, wherein said two effector mechanisms are pivotally mounted to said shaft along a pivot axis extending parallel to said longitudinal axis of said distal end of said shaft, wherein said two effector mechanisms are configured to move between (i) a closed position wherein said two effector mechanisms fold concentrically about said
- said at least one gripping element comprises a suction pod for drawing tissue against the effector mechanism and for maintaining the tissue in such engagement while suction is maintained; at least one actuating mechanism mounted to said proximal end of said shaft; and at least one connection mechanism connecting said at least one actuating mechanism to said two effector mechanisms, whereby a user may utilize said at least one actuating mechanism to actuate said two effector mechanisms so as to reconfigure tissue; positioning said two effector mechanisms in said closed position; advancing said apparatus so that said distal end of said shaft is positioned adjacent tissue to be reconfigured; positioning said two effector mechanisms in said open position; gripping tissue against said distal end of said shaft and against said two effector mechanisms; and positioning said two effector mechanisms in said closed position so as to reconfigure the gripped tissue and capture that tissue against said shaft.
- a method for reconfiguring tissue comprising: providing apparatus comprising: a shaft having a distal end and a proximal end, wherein said distal end of said shaft comprises at least one gripping element for drawing tissue against said shaft and for maintaining the tissue in such engagement while suction is maintained; ( an effector mechanism movably mounted to said distal end of said shaft, said effector mechanism comprising at least one gripping element for gripping tissue to that effector mechanism, said effector mechanism being configured to capture the gripped tissue against said shaft, wherein said distal end of said shaft comprises a longitudinal axis, wherein said effector mechanism is pivotally mounted to said shaft along a pivot axis extending transverse to said longitudinal axis of said distal end of said shaft, wherein said effector mechanism is configured to move between (i) a closed position wherein said effector mechanism folds concentrically about said distal end of said shaft, and (ii) an open position wherein said effector mechanism rises over said shaft, and wherein
- a method for reconfiguring tissue comprising: providing apparatus comprising: a shaft having a distal end and a proximal end; a plurality of effector mechanisms mounted to said distal end of said shaft, each said effector mechanism comprising at least one gripping element for gripping tissue to that effector mechanism, said plurality of e fector mechanisms being configured to capture the gripped tissue against said shaft, wherein said distal end of said shaft comprises a longitudinal axis, wherein said plurality of effector mechanisms extend parallel to said longitudinal axis of said distal end of said shaft, wherein said plurality of effector mechanisms are configured to move between (i) a first position wherein said plurality of effector mechanisms collectively form a tubular configuration, and (ii) a second position wherein said plurality of effector mechanisms collectively form a non- tubular configuration, and wherein said at least one gripping element comprises a suction pod for drawing tissue against the effector mechanism and for maintaining the tissue in such engagement while suction
- a method for treating GERD comprising: creating a neoesophagus that extends into the abdomen.
- Figs. 1-4 are a series of schematic views showing a first preferred embodiment of the present invention
- Figs. 5-10 are a series of schematic views showing the apparatus of Figs. 1-4 being used in a procedure to treat
- FIG. 11 and 12 are schematic views showing an alternative form of the procedure shown in Figs. 5-10;
- Figs. 13-18 are a series of schematic views showing a second preferred embodiment of the present invention.
- Figs. 19-22 are a series of schematic views showing the apparatus of Figs. 13-18 being used in a medical procedure;
- Figs. 23 and 24 are schematic views showing alternative forms of the procedure shown in Figs. 19-22; and
- Figs. 25-31 are a series of schematic views showing a third preferred form of the present invention.
- the present invention relates to apparatus and methods for manipulating tissue.
- This invention can be used to manipulate tissue so as to create many different shapes and configurations.
- apparatus is provided which can be used to bring opposite walls of a hollow organ or viscus into close apposition such that they form a tube of tissue, and/or apparatus is provided which can be used to create a cylinder or tube of tissue wrapped partially or entirely by an out-pouching of the same hollow viscus.
- apparatus can be used to create an inner tube of stomach or esophagus wrapped by a pouch of stomach, and/or apparatus is provided which can be used to create a tube of stomach in continuity with the esophagus, whereby to essentially create a neoesophagus which may be wrapped partially or entirely by an outer pouch of the stomach, the lumen of which is in continuity with the main lumen of the stomach, esophagus, and neoesophagus.
- the present invention comprises multiple components which may be used alone, together, or in various combinations.
- the present invention may provide stabilizing means (such as suction, pins, barbs, hooks, adhesive, glue, magnets, etc.) to effect conformational changes in tissue configurations, and fixation means (such as staples, pins, barbs, hooks, adhesive, glue, magnets, etc.) to secure the tissue in such configuration after the stabilizing means are withdrawn.
- stabilizing means such as suction, pins, barbs, hooks, adhesive, glue, magnets, etc.
- fixation means such as staples, pins, barbs, hooks, adhesive, glue, magnets, etc.
- novel apparatus may be used to treat disease states.
- disease states One of these disease states is GERD.
- Another of these disease states is obesity.
- various embodiments of the invention will sometimes be discussed in the context of these two disease states, i.e., GERD and obesity. However, it is to be appreciated that this is intended to be by way of example and not limitation, and that the present invention may be applied to the treatment of other disease states as well.
- the apparatus comprises a flexible tube with effector mechanisms on the distal end and actuating mechanisms on the proximal end.
- other devices including but not limited to endoscopes, cables, pulleys, staplers, magnets, other tubes, devices for conveying a variety of energy sources, tubes for delivering adhesives and glues, etc.
- the walls of the tube may also have one or more additional l ⁇ mens through which one or more devices may be passed.
- the effector mechanisms may be used to grasp tissue to assist in manipulating that tissue.
- the effector mechanisms may take any form that will g ip the tissue, such as suction, one or more hooks, one or more staples, glue, magnets, etc.
- the preferred embodiments disclosed herein utilize suction to grasp the tissue.
- the suction is applied to the tissue through pods . These pods are mounted on the distal end of the flexible tube.
- the pods may comprise any shape or configuration consistent with the application intended.
- the pods comprise a low-profile curvilinear box with one or more holes formed therein. The side of the box with the one or more holes contacts the tissue.
- Suction can be applied to the port through one or more small conduits which run inside, outside, or in the sidewall of the flexible tube. Suction can be applied to the conduits by any means capable of generating satisfactory suction (e.g., a suction pump) .
- a suction pump e.g., a suction pump
- the suction conduits run inside the sidewall of the flexible tube. The distal ends of the conduits are connected to the pods, and the proximal ends of the conduits are connected to the suction source.
- the actuating mechanisms are disposed at least in part on the proximal end of the flexible tube.
- the actuating mechanisms are used to effect movement of the effector mechanisms which engage and manipulate the tissue.
- the actuating mechanisms may move the effector mechanisms by any of the various means well known in the art including, but not limited to, cables, cogs., motor systems, remote wireless systems, etc.
- cables are used to move the effector mechanisms. More particularly, the effector mechanisms are connected to a series of cables that run within the flexible tube. These cables run the length of the tube, from the distal end to the proximal end.
- the flexible tube itself can be directly maneuvered by the doctor, or the flexible tube can be mounted on another instrument (e.g., an endoscope) and passively steered by maneuvering of that other instrument.
- another instrument e.g., an endoscope
- the apparatus may comprise a visualization unit to assist in appropriately directing the apparatus.
- This visualization unit may be an integral component of the system, similar to a flexible endoscope or ultrasound probe or wireless video transmitter, etc.
- the visualization unit may be independent of the system, e.g., it may comprise a CT or MRI machine.
- the present invention could be employed without visual aid.
- an endoscope is used to assist in visualization, with the endoscope passing through the central lumen of the flexible tube. Once the effector mechanisms have manipulated the tissue into proper position, the tissue can be held in position by various types of fixation mechanisms including, but not limited to, staples, sutures, magnets, glue, etc.
- staples are located in the flexible tube, and the effector mechanisms can act as anvils for the staples.
- These staples may be actuated by actuating mechanisms (e.g., cables) similar to those used to manipulate the effector mechanisms.
- actuating mechanisms e.g., cables
- GERD is the most common gastrointestinal problem in humans, and may be treated by altering the configuration of the esophagus and/or stomach.
- the present invention comprises a novel apparatus and method for manipulating the esophagus and/or stomach so as to alter the configuration of the esophagus and/or stomach and thereby treat GERD.
- severe obesity is associated with a large number of health related problems, and may be treated by manipulating the tissues of the gastrointestinal tract to alter the size and/or shape of the stomach.
- the present invention provides a novel apparatus and method for manipulating the tissues of the gastrointestinal tract so as to alter the size and/or shape of the stomach and thereby treat obesity.
- an apparatus 5 comprises a flexible tube 10 having an outer surface 15 and an inner lumen 20.
- Various devices e.g., working tools, scopes, etc.
- Pods 25 (shown in Figs. 3 and 4 but omitted from the remaining drawings for purposes of clarity) are provided in the outer surface 15 of flexible tube 10, whereby tissue may be drawn to the outer surface 15 of flexible tube 10.
- Conduits 30 (shown in Figs. 3 and 4 but omitted from the remaining drawings for purposes of clarity) are formed in the side wall of flexible tube 10 and supply suction to pods 25. Effector mechanisms 35 are configured to concentrically close about flexible tube 10.
- effector mechanisms 35 are pivotally mounted to flexible tube 10 by a mount 40, with actuating mechanism 45 (preferably including a flexible tube 50) being used to position flexible tube 10 and effector mechanisms 35 relative to the tissue, and to open and close effector mechanisms 35 relative to flexible tube 10.
- actuating mechanism 45 preferably including a flexible tube 50
- pods 25 are also provided on the interior walls of effector mechanisms 35.
- Conduits 30 may be provided in the interior walls of effector mechanisms 35 and extend out through flexible tube 50 for connection to a vacuum source.
- Fixation mechanisms in the form of staples 55 are preferably provided in the sidewall of flexible tube 10. Actuating mechanisms of the sort well known in the art (not shown) may be provided to drive staples 55 radially outward from flexible tube 10; when effector mechanisms 35 are closed down concentrically around flexible tube 10 (Figs. 1 and 2), the effector mechanisms can serve as anvils to bend the staples closed.
- Apparatus 5 can be used to gather and fold tissue into a tube configuration, e.g., for treatment of GERD. More particularly, with effector mechanisms 35 in a closed position (e.g., Figs. 1 and 2), apparatus 5 is advanced down the esophagus and into the stomach. Next, and looking now at Fig. 5, effector mechanisms 35 are brought to the open position in the main body of the stomach. Then apparatus 5 is brought up to the angle of the stomach near the gastroesophageal junction (Figs. 6 and 7). Next, suction is applied to pods 25 (Fig. 8) , thereby bringing tissue into proximity with outer surface of flexible tube 10 and the underside of effector wings 35.
- a closed position e.g., Figs. 1 and 2
- effector mechanisms 35 are brought to the open position in the main body of the stomach. Then apparatus 5 is brought up to the angle of the stomach near the gastroesophageal junction (Figs. 6 and 7). Next, suction is applied to pods 25
- tissue brought into proximity with the outer surface of flexible tube 10 will essentially form a neoesophagus.
- effector wings 35 are brought to the closed position (Fig. 9).
- the anterior and posterior pouches of stomach are folded around the outer wall of the neoesophagus.
- Staples 55 may then be activated so as to hold the walls of the tube of tissue TT together and secure the wrapped pouches in place, and the apparatus 5 removed (Fig. 10) .
- a tube of tissue TT having a lumen TL, can be created that is surrounded by pouches of stomach that are in luminal continuity with the main lumen of the stomach.
- this tube is effectively a wrapped neoesophagus which may minimize gastroesophageal reflux.
- the novel apparatus and method may be used to create a tube of esophagus (e.g., neoesophagus) that may extend into the abdomen.
- This tube of esophagus may then be surrounded in part or completely by the stomach (i.e., the wrap) .
- This neoesophagus may prevent reflux because the lengthening of the esophagus has caused it to be in the abdominal cavity and is thus under positive pressure. This positive pressure may cause the neoesophagus to collapse, thereby preventing reflux.
- This neoesophagus may also prevent reflux because it is wrapped by the stomach in such a way that the lumen of the wrap of stomach may exert a collapsible force on the esophagus and/or neoesophagus as it distends, thereby preventing reflux.
- the wrap effected by apparatus 5 may be of various circumferential degree.
- Fig. 10 depicts a wrap of approximately 270 degrees, however, this wrap could be anywhere up to 360 degrees .
- a fluidtight tube of tissue TT it may be important to provide a fluidtight tube of tissue TT.
- the apparatus 5 is to create a wrapped neoesophagus to treat GERD
- Staples (fired outwardly from flexible tube 10) may serve to hold the fluidtight material 65 to the outside surface of the tube of tissue TT.
- stapling mechanisms of the sort well known in the art may be provided on the underside of effector wings 35, whereby the staples 70 (using the outside wall of flexible tube 10 as an anvil) may secure the fluidtight material 65 to the outer wall of the tube of tissue TT. See Fig. 12.
- flexible tube 10 and effector mechanisms 35 may omit suction pods or other tissue gripping mechanisms, and the stomach tissue may be wrapped around the neoesophagus by using appropriate apparatus geometry moving about the neoesophageal fixation line. This may be facilitated by vacuum evacuation of the stomach contents to bring the stomach walls into contact with the effector arms.
- an apparatus 105 comprises a flexible shaft 110 with an actuator end 115 and an effector end 120.
- the effector end 120 has one or more effector mechanisms 125.
- the distal end of the device has a hollow tube 130 with a central lumen 135 (Figs. 14 and 16) .
- Objects such as a working instrument, endoscope, etc. can pass through the central lumen 135.
- Effector mechanism 125 is adapted to open and close about an end pivot 140.
- a septum 145 has one portion anchored to effector mechanism 125 and another portion anchored to hollow tube 130.
- septum 145 enters the interior of effector mechanism 125 via a slot 150 (Fig. 16)
- septum 145 enters the side wall of hollow cylinder 130 via a slot 155.
- the top portion of hollow tube 130, the underside of effector mechanism 125 and/or the septum 145 have suction pods 160 disposed therein, with suction being supplied to the suction pods 160 via flexible shaft 110.
- effector mechanism 125 can be opened relative to hollow tube 130, suction applied to draw tissue against effector mechanism 125, hollow tube 130 and/or septum 145, and then effector mechanisms 125 closed so as to reconfigure the tissue.
- the underside of effector mechanism 125 includes a plurality of staples 165 which can be fired out of the bottom of effector mechanism 125 by stapling mechanisms of the sort well known in the art (not shown) .
- Apparatus 105 can be used in various ways to therapeutically reconfigure tissue.
- apparatus 105 has its effector mechanism 125 placed into its closed position (Figs. 13 and 14), the distal end of apparatus 105 is positioned between two opposing walls of tissue T, and effector mechanism 125 is opened (Fig. 19) .
- suction is applied so as to cause the tissue T to be drawn against effector mechanism 125, hollow tube 130 and/or septum 145 (Fig. 20) .
- effector mechanism 125 is closed and staples 165 set (using the outer surface of hollow tube 130 as an anvil). See Fig. 21.
- effector mechanism 125 is opened so as to release the tissue, and the apparatus withdrawn, leaving the tissue in the reconfigured arrangement shown in Fig. 22.
- the staple 165 may be supported by one (Fig. 23) or two (Fig. 24) pieces of material 170, with the material being carried into position by effector mechanism 125 (in the example shown in Fig. 23) or by effector mechanism 125 and hollow tube 130 (in the example shown in Fig. 24) .
- an apparatus 205 comprises a flexible tube 210 with an outer surface 215, an inner surface 220 and a central lumen 225.
- the sidewall 230 of flexible tube 210 may be solid, and/or the sidewall 230 of flexible tube 210 may be hollow through which other devices such as suction tubes, cables, wires, etc. may run.
- Apparatus 205 includes an effector end 235 and an actuator end 240.
- the effector end 235 comprises a plurality of effector mechanisms 245.
- the effector mechanisms 245 can be parallel to but otherwise independent of one another (e.g., as a series of independent elements collectively forming the distal end of hollow tube 210) or one or more of the effector mechanisms 245 can be connected to one another (e.g., so as to form a slotted tube configuration, such as that shown in Figs. 25, 28 and 29) .
- Each of the effector mechanisms 245 is provided with one or more suction pods 250 (only shown on some of the effector mechanisms 245 for clarity of illustration) for gripping tissue and one or more fastening elements 255.
- the fastening elements 255 may be any elements that are adapted to secure themselves to one another; in one preferred form of the invention, fastening elements 255 are magnets.
- the actuating end 240 has suction ports 260 which connect to suction pods 250, whereby suction may be applied to suction pods 250, and cables 270 to individually manipulate the relative position of effector mechanisms 245 (e.g., to move them longitudinally relative to the long axis of hollow tube 210, or to move them laterally relative to the longitudinal axis of hollow tube 210, etc.).
- Figs. 28 and 29 show how cables 270 may be used to manipulate the effector end 235 of hollow tube 210 from a normal round configuration (Fig. 28) to a folded configuration (Fig. 29).
- tissue may first be gripped by moving the effector end 235 of tube 210 adjacent to tissue and applying suction to suction ports 260, whereby tissue will be drawn against suction pods 250, and the tissue may thereafter be folded by actuating cables 270 whereby to bring the tissue together (Fig. 29).
- This action simultaneously brings fastening elements 255 into proximity with each other, whereby the fastening elements 255 can secure the tissue in such position.
- Figs. 30 and 31 shown the same structure shown in Figs. 29-29, except that an additional fastener element 255A is provided on the device.
- This additional fastening element 255A can be placed anywhere in, on or around the device so that additional folds of tissue may be created.
Abstract
Description
Claims
Priority Applications (3)
Application Number | Priority Date | Filing Date | Title |
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AU2003293191A AU2003293191B2 (en) | 2002-11-29 | 2003-12-01 | Apparatus and method for manipulating tissue |
CA2507803A CA2507803C (en) | 2002-11-29 | 2003-12-01 | Apparatus and method for manipulating tissue |
EP03790182A EP1590517A4 (en) | 2002-11-29 | 2003-12-01 | Apparatus and method for manipulating tissue |
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US42956802P | 2002-11-29 | 2002-11-29 | |
US60/429,568 | 2002-11-29 | ||
US45329403P | 2003-03-11 | 2003-03-11 | |
US60/453,294 | 2003-03-11 | ||
US45812803P | 2003-03-27 | 2003-03-27 | |
US60/458,128 | 2003-03-27 |
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WO2004050971A3 WO2004050971A3 (en) | 2004-11-04 |
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PCT/US2003/038110 WO2004050971A2 (en) | 2002-11-29 | 2003-12-01 | Apparatus and method for manipulating tissue |
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US (2) | US7892245B2 (en) |
EP (1) | EP1590517A4 (en) |
AU (1) | AU2003293191B2 (en) |
CA (1) | CA2507803C (en) |
WO (1) | WO2004050971A2 (en) |
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Also Published As
Publication number | Publication date |
---|---|
CA2507803A1 (en) | 2004-06-17 |
US7892245B2 (en) | 2011-02-22 |
US20040193190A1 (en) | 2004-09-30 |
WO2004050971A3 (en) | 2004-11-04 |
EP1590517A4 (en) | 2010-03-10 |
CA2507803C (en) | 2012-12-04 |
AU2003293191A1 (en) | 2004-06-23 |
US8617189B2 (en) | 2013-12-31 |
EP1590517A2 (en) | 2005-11-02 |
US20120010639A1 (en) | 2012-01-12 |
AU2003293191B2 (en) | 2008-08-07 |
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