medical device therapy for obesity and metabolic disease – the
TRANSCRIPT
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Richard I. Rothstein, MDRichard I. Rothstein, MDInterim Chair, Department of MedicineInterim Chair, Department of Medicine
Chief, Section of Gastroenterology and HepatologyChief, Section of Gastroenterology and HepatologyProfessor of Medicine and of SurgeryProfessor of Medicine and of Surgery
Dartmouth Medical SchoolDartmouth Medical SchoolHanover, NHHanover, NH
Medical Device Therapy for ObesityMedical Device Therapy for Obesity and Metabolic Disease and Metabolic Disease –– The Current LandscapeThe Current Landscape
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Focus on Endoscopic Therapies Focus on Endoscopic Therapies for Primary Treatmentfor Primary Treatment
Devices will be mentioned to illustrate mechanismsNo endorsement intended for any devices or mechanismsNot all devices will be reviewed
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1999
Obesity Trends (BMI 30) Among U.S. Adults 1990, 1999, 2008
2008
1990
No Data <10% 10%–14% 15%–19% 20%–24% 25%–29% ≥30%
CDC.GOV
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The Environment: Portion SizeThe Environment: Portion Size
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Non-surgical Treatment for Obesity
Diet and exercise
(5 - 7% weight loss)
Behavioral therapy plus diet & exercise (10%)
Pharmacotherapy• modest efficacy• weight regain after stopping meds• adverse effects• uncertain long-term safety
After Stylopoulos, Aguirre GIE 2009; 70:1167-75
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Vertical Banded Vertical Banded Gastroplasty Gastroplasty
(VBG)(VBG)
Surgery for Surgery for ObesityObesity
Restrictive and Restrictive and MalabsorptiveMalabsorptive
ProceduresProcedures
Adjustable Adjustable Gastric Band Gastric Band
(AGB)(AGB)
Sleeve Sleeve Gastrectomy Gastrectomy
(SG)(SG)
Biliopancreatic Biliopancreatic diversion (BPD)diversion (BPD)
Duodenal Switch Duodenal Switch (DS)(DS)
RouxRoux--enen--Y Y Gastric Bypass Gastric Bypass
(RYGB)(RYGB)
Surgery for Surgery for ObesityObesity
Restrictive Restrictive ProceduresProcedures Gastric Gastric
Imbrication Imbrication (GI)(GI)
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Weight Change after Surgery
Sjostrom L et al. N Engl J Med 2007;357:741-752
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Rates of Remission of Diabetes
AdjustableGastric Banding
Roux-en-YGastric Bypass
BiliopancreaticDiversion
98%38% 84%Buchwald H., JAMA 2004
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RYGB: A Complex of 5 Operations
CONFIDENTIAL
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Gastric Bypass: Five Operations
1. Isolation of gastric cardia
CONFIDENTIAL
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Gastric Bypass: Five Operations
2. Exclusion of distal stomach
CONFIDENTIAL
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Gastric Bypass: Five Operations
3. Exclusion of duodenum and proximal jejunum
CONFIDENTIAL
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Gastric Bypass: Five Operations
4. Exposure of distal jejunum to undigested nutrients
CONFIDENTIAL
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Gastric Bypass: Five Operations
5. Partial vagotomy
CONFIDENTIAL
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Effects of Surgery on Diabetes
Potential Mechanisms
Weight loss
Decreased nutrient intake
Changes in GI physiology or signaling
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Weight and diabetes control after RYGBWeight and diabetes control after RYGB
Mason E. Obes Surg 2005; 15: 459Mason E. Obes Surg 2005; 15: 459--6161Rubino F et al. Ann Surg 2006; 244: 741Rubino F et al. Ann Surg 2006; 244: 741--99
«« DistalDistal
mechanism mechanism ––
Hindgut theoryHindgut theory
»»
Nutrients – fat, carbs, protein
L Cells
GLP-1, PYY, Oxyntomodulin
Effects on glucose homeostasis (incretins)
- Insulin secretion- insulin sensing
and sensitivity- Beta cell mass - Glucagon secretion
Effects on appetite and weight
- Gastric emptying- Appetite- Acid secretion
Hindgut theory – increased nutrients
to distal gut
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«« ProximalProximal
mechanism mechanism ––
Foregut theoryForegut theory
»»
Weight and diabetes control after RYGBWeight and diabetes control after RYGB
Ghrelin
Eating
Nutrients to the foregut
“Anti-incretins”
Effects on appetite and weight
- Gastric emptying- Appetite- Acid secretion
Effects on glucose homeostasis
- Insulin secretion- insulin sensing
and sensitivity- Beta cell mass
Foregut theory – bypass duodenal nutrient passage
Rubino , F. Diabetes Care Feb 2008 Vol. 31 No. 2; S290-S296Spector, D, Shikora S. Int J Clin Pract. Feb 2010, 62 (Suppl. 66) 53-58
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Endoscopic PossibilitiesEndoscopic Possibilities
•• Bypass proximal duodenum and/or stomachBypass proximal duodenum and/or stomach
•• Compartmentalize stomach/restrict volumeCompartmentalize stomach/restrict volume
•• Delay stomach emptyingDelay stomach emptying
•• Mimic effects of surgery on weight and DMMimic effects of surgery on weight and DM
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EndoBarrier EndoBarrier
Alteration of gastric outlet
Food goes down liner – duodenal exclusion
Digestive juices go around liner
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EndoBarrier SystemEndoBarrier System
Implant
Co-axial Delivery CatheterRetrieval System
•• AnchorAnchor•• NitinolNitinol•• Large proximal openingLarge proximal opening•• Barbs in each directionBarbs in each direction•• Retrieval drawstringsRetrieval drawstrings
•• SleeveSleeve•• Impermeable fluoropolymerImpermeable fluoropolymer•• 61 cm (2 ft) length61 cm (2 ft) length•• Radiopaque markersRadiopaque markers
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ValenTxA b s t r a c t :
The present invention provides devices and methods for attachment of an implanted device, such as an artificial stoma device (202), a gastrointestinal sleeve device (200, 258, 278, 428, 458, 560) or an attachment cuff (214, 550, 570), within a patient's digestive tract for treatment of obesity. Special surgical fasteners (100, 130, 222, 240, 250, 276, 530, 542) provide a lasting and durable attachment to the gastrointestinal tissue without causing excessive pressure that could result in tissue erosion and detachment of the implanted device. Fastener delivery devices (150) that facilitate peroral placement and deployment of fasteners (100, 130, 222, 240, 250, 276, 530, 542) and secondary devices are also provided. Also described are implantable devices and attachment means (230, 234) that avoid causing excessive pressure within the tissue by having compliance that is compatible with the gastrointestinal tissues where it is attached.
VALENTX, INC. [US/US]; 200 Homedale Rd., Hopkins, MN 55343 (US) (All Except US). KAGAN, Jonathan [US/US]; 200 Homedale Rd., Hopkins, MN 55343 (US) (US Only). DANN, Mitchell [US/US]; 4020 West Lake Creek Dr., Wilson, WY 83014 (US) (US Only). FLUET, Greg [US/US]; 620 1/2 East Hall St., Jackson, WY 83002 (US) (US Only). IKRAMUDDIN, Sayeed [US/US]; Rm. 304, 410 E. River Rd., Minneapolis, MN 55455 (US) (US Only). SWAIN, Paul [--/GB]; 41 Willow Rd., London NW3 1TN (GB) (US Only). THOMAS, Richard [US/US]; 556 Trapelo Rd., Belmont, MA 02478 (US) (US Only). VON HOFFMANN, Gerard [US/US]; 3 Via Presea, Trabuco Canyon, CA 92679 (US) (US Only). WILMORE, Mary, Lynn [US/US]; P.O. Box 516, Victor, ID 83445 (US) (US Only).
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Valentx Endo Bypass SleeveValentx Endo Bypass Sleeve
Endo Bypass SleeveRYGB
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Techniques for Reduction of Techniques for Reduction of Gastric VolumeGastric Volume
•• Balloons and bezoarsBalloons and bezoars
•• SewingSewing
•• StaplingStapling
•• ImplantsImplants
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Balloons and Devices Balloons and Devices to Fill Gastric Spaceto Fill Gastric Space
•
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ReShape DuoReShape Duo Delivery SystemDelivery System
ReShape
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ReShapeReShape
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Spatz BalloonSpatz BalloonAdjustable
Prevents migration of
balloon
Visible on imaging
Retrievable
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Full Sense Device
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Full Sense Device
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Some Sewing ToolsSome Sewing Tools
NDONDO
EndoCinchEndoCinch
GG--ProxProx
TASTAS
Eagle ClawEagle Claw
SpidermanSpiderman
SafeStitchSafeStitch
StomaPhyxStomaPhyx
OverStitchOverStitch
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Gastric restriction and Gastric restriction and CompartmentalizationCompartmentalization
EndoCinch concept
(Swain 2002)
EndoCinch attempt
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SafeStitchSafeStitch
Charles Filipi, 2007
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The TOGa System (Satiety)The TOGa System (Satiety)TOGa Sleeve StaplerTOGa Sleeve Stapler
•• 54F (18mm) diameter54F (18mm) diameter•• Designed to use an 8.6 mm OD endoscopeDesigned to use an 8.6 mm OD endoscope•• Direct visualizationDirect visualization•• Creates stapled sleeve along lesser Creates stapled sleeve along lesser curvecurve
TOGa Restrictor • 45F (15mm) diameter• Delivered alongside endoscope• Creates stapled “pleats”
at distal end of sleeve, restricting outflow
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Sleeve Stapler inserted over guidewire, positioned on lesser
curveSail / septum deployed to
spread tissueendoscopic view –
Sail / septum
vacuum applied to capture anterior and
posterior tissuestapler jaws closed and
fired
Result is stapled sleeve. Repeat to create longer sleeve
, then use restrictor
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BaroSense Transoral Platform
Creates a Small proximal Pouch distal to the GE
junction
Full thickness plication anchor points
Food Outlet
•TERIS (Transoral Endoscopic Restrictive Implant System)
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Hour Glass Procedure
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Alteration of Gastric MotilityAlteration of Gastric Motility
•• BOTOXBOTOX
•• NeuromodulationNeuromodulation
•• Pyloroduodenal obstructing devicesPyloroduodenal obstructing devices
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BOTOX InjectionBOTOX Injection
•• In animal studies In animal studies -- delayed gastric emptying delayed gastric emptying
from antral injectionsfrom antral injections
•• Human studies showed variable results for Human studies showed variable results for antral injectionsantral injections
•• Adding fundic injection in RCT:Adding fundic injection in RCT:wt loss 11 vs 5 kg; p<0.001wt loss 11 vs 5 kg; p<0.001BMI reduction 4 vs 2; p<0.001BMI reduction 4 vs 2; p<0.001Delayed stomach emptyingDelayed stomach emptying
Foschi D, et al. Int J Obes 2007; 31: 707-12
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Electrical Neuro-modulation• EnteroMedics• Leptos Biomedical• IntraPace• MetaCure• Medtronic (Transneuronix)
Current surgical placement could evolve to endoscopic
Mechanisms:increase satietyreduce appetite and food intakealter neuro-endocrine responsesaffect gastric and intestinal motility
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Transpyloric Shuttle TPS™Intermittent sealing of pylorus in concert
with peristalsis may:
• Delay gastric emptying• Induce early satiety
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TPS™ within delivery sleeve TPS™ prior to locking
Locked TPS™
Entirely endoscopic … Self-placing… Non-anchored…Multi-year dwell
TPS™ after unlocking
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SatiSphereSatiSphere
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Endocore Pyloric ValveEndocore Pyloric Valve
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Aspire BariatricsAspire Bariatrics
•• Divert ingested nutrient flow out of the Divert ingested nutrient flow out of the bodybody
•• BariAssist GBariAssist G--ShuntShunt
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Future DevelopmentsFuture Developments
•• NOTESNOTES
•• CapsulesCapsules
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Role of NOTES
• Compartmentalization
• Gastrojejunostomy
• Sleeve Gastrectomy
“Human transvaginal sleeve gastrectomy: initial experience”
Ramos AC, Zundel N, Neto MG, Maalouf MSurg Obes Relat Dis. 2008 Sep-Oct;4(5):660-3
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• The endoscope advanced into the peritoneal cavity
• A loop of jejunum identified and pulled into the stomach
Gastrojejunostomy
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The loop of jejunum is secured with sutures to the stomach
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Incision made into the jejunal loop using a needle-knife
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The open ends of the incision are secured to the gastric incision with a second line of sutures completing the gastrojejunostomy
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Bariatrion Gastric Bypass Device Currently Lap-Endo Hybrid Approach
Schurr MO, HO C, Rieber F et al. Min Invas Surg 2009; 18:273-9
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Capsular Intragastric BalloonCapsular Intragastric Balloon
(a) Deflated balloon ) Inflated balloon
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Endolumenal Treatment for ObesityEndolumenal Treatment for Obesity
Less Expensive Less Effective
More Expensive More Effective
Surgery
EndoscopicEndoscopicProceduresProcedures
Medication
Diet and Exercise
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We anticipate the development of We anticipate the development of endoscopic treatments that will help endoscopic treatments that will help
manage our most recent human manage our most recent human evolutionevolution……..