WO2009097482A1 - Gastric inflation band with integrated infusion catheter - Google Patents
Gastric inflation band with integrated infusion catheter Download PDFInfo
- Publication number
- WO2009097482A1 WO2009097482A1 PCT/US2009/032536 US2009032536W WO2009097482A1 WO 2009097482 A1 WO2009097482 A1 WO 2009097482A1 US 2009032536 W US2009032536 W US 2009032536W WO 2009097482 A1 WO2009097482 A1 WO 2009097482A1
- Authority
- WO
- WIPO (PCT)
- Prior art keywords
- band
- gastric band
- chamber
- gastric
- inflation bladder
- Prior art date
Links
Classifications
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61F—FILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
- A61F5/00—Orthopaedic methods or devices for non-surgical treatment of bones or joints; Nursing devices; Anti-rape devices
- A61F5/0003—Apparatus for the treatment of obesity; Anti-eating devices
- A61F5/0013—Implantable devices or invasive measures
- A61F5/005—Gastric bands
- A61F5/0053—Gastric bands remotely adjustable
- A61F5/0056—Gastric bands remotely adjustable using injection ports
Definitions
- This invention relates to a device for the treatment of obesity, and, more specifically, to an inflatable band that can be surgically placed around the stomach while also providing a means for direct drug and therapeutic agent delivery to the site of band placement.
- One method to treat obesity is to place an inextensible band on the outside of a portion of the patient's stomach thereby ereating a stoma with reduced diameter whieh restriets the patient's food intake.
- Kuzmak et al. describes a gastrie banding device in U.S. Pat. 4,592,339, which is made of inextensible material and needs to be surgically tightened to achieve the desired diameter of the stoma opening.
- the Kuzmak band also provides an inflatable portion that allows small post-operational adjustment of the diameter of the stoma after implantation by injection or withdrawal of fluid from an implanted injection port.
- U.S. Pat. 5,601,604 issued to Vincent describes a gastric band that incorporates a fastening means and an inflatable inner surfaee that allows a more versatile range of adjustment to the stoma.
- the present invention is an inflatable gastric band that incorporates a fluid channel located proximate to or within an outer surface of the band, and an inflatable bladder on a stomaeh-faeing side of the band.
- the gastric band attaches to a double lumen eatheter, with one of the lumens communicating with the fluid channel and the other lumen communicating with the inflatable bladder.
- Each lumen also communicates with a respective chamber of a dual infusion port. Injection or withdrawal of fluid in one chamber of the infusion port allows adjustment of the diameter of the stoma, by expanding/contracting the inflatable bladder, while the injection of drugs or therapeutic agents into the other chamber allows the infusion of drugs or agents directly into the abdominal cavity of a gastric band recipient.
- the inflatable bladder can be continuous or segmented.
- a segmented bladder reduces the possibility of a pinching and/or a folding of the inner surface of the gastric band during expansion/contraction, thereby lessening a chanee of stomach pinching or irritation.
- FIG. IA is a schematic drawing of a gastric inflatable band according to one embodiment of the present invention.
- FIG. IB is an exemplary cross-section of a catheter portion of the invention shown in FIG, IA;
- FIG. 1C is a schematic top view of an outer band side of a band portion of the invention shown in FIG. IA;
- FIG. ID is a schematic side view of the outer band side of the band portion of the invention shown in FIG. 1C;
- FIG. IE is a schematic bottom view of an inner band side of the band portion of the invention shown in FIG. 1C.
- the present invention provides an adjustable gastric band adapted for placement by laparoscopic surgery around a patient's stomach.
- the gastric band provides for delivery of therapeutic agents directly to the band placement site.
- the present invention provides a configuration of an inflatable bladder that avoids folds and pinches, thereby reducing the possibility of stomach irritation.
- FIG. I A provides a prospective view of one embodiment of the present invention.
- the device comprises a band portion 100, a catheter portion 200, and a two chambered infusion port 300.
- the band portion 100 comprises an outer band member 110 and an inner inflatable bladder 120.
- the outer band member 110 is made of a tissue compatible material that is flexible, but preferably not extensible.
- the inner inflatable bladder 120 is also made of tissue compatible material that is elastic.
- the inflatable bladder 120 can be filled with fluid, such as saline.
- the band portion 100 further comprises a head end 104 and a tail end 106,
- the head end 104 comprises a locking meehanism 108 to reeeive the tail end 106.
- the locking mechanism 108 comprises a hole 111 eut precisely in the onter band member 110.
- the tail end 106 comprises a retaining ring 210 that engages the locking mechanism 108 on the head end 104.
- the catheter portion 200 is pulled through the hole 111 in the outer band member 110 until the retaining ring 210 emerges on the other side of the outer band member 110 and locks in place.
- the band portion 100 When locked, the band portion 100 forms a ring with fixed diameter around the patient's stomach.
- the inflatable bladder 120 is adapted to expand or subsequently contract (deflate) depending on the amount of fluid delivered thereto. Infusion to or withdrawal of fluid from the inflatable bladder 120 allows for easy adjustment of an inner diameter of the band portion 100. This, in turn, adjusts the diameter of the stoma of the patient's stomach.
- the band portion 100 communicates with the infusion port 300 through the catheter portion 200.
- the catheter portion 200 comprises two lumens 201, 202.
- FIG. IB shows a cross- section view of one embodiment of the catheter portion 200, illustrating that the two internal lumens 201, 202 each have a "D" shaped configuration,
- the lumens 201, 202 can be configured to any desired shape presently known in the catheter art.
- the catheter portion 200 of present invention may also include more than two lumens.
- the first lumen 201 is in fluid tight communication, on one end, with the inflatable bladder 120 and on the other end is in fluid tight communication with a first chamber 310 of the infusion port 300. The amount of fluid within the inflatable bladder 120 can thus be adjusted by injecting or withdrawing fluid from the corresponding chamber 310 of infusion port 300, thereby controlling the inner diameter of the band portion 100.
- FIG. 1C shows a top view of the band portion 100 of the present invention.
- the outer band member 110 further comprises a fluid channel 112 approximate to the outer surface of the band member 110. Openings such as slits or holes are formed in the outer wall of the fluid channel 112.
- the outer wall of the fluid channel 112 is made of a flexible material that is essentially flat and uniform in thickness. Slits 113 are precisely cut into the outer wall of the fluid channel 112.
- These slits 1 13 are essentially one-way valves that open and allow free communication of fluid inside of the flnid channel 112 to the abdominal eavity when the hydrostatic pressure inside the fluid channel is higher than a predetermined threshold compared to the outside pressure.
- the slits 113 When the pressure in the abdominal cavity is equal or higher than the fluid pressure inside the fluid channel 1 12, the slits 113 elose and prevent retrograde fluid flow into the fluid channel 112.
- the minimum amount of pressure needed to open the slits may be adjusted by varying the number of slits, length of the slits, the thickness and/or elasticity of the fluid channel wall.
- FIG. 1C shows the slits or holes 113 only on the outer side of the band portion 100 (i.e., the side opposite the inflatable bladder 120), the fluid channel 112 eould be configured so that the slits or holes 113 open to the inner side of the band portion 100, or to the longitudinal edges.
- the fluid channel 112 may be integral to, or exist essentially within, the band member 110, thereby allowing slits or holes to be loeated variously about the inner and outer sides, as well as along the edges, of the band member 110.
- the fluid ehannel 112 eomprises a permeable material along at least a portion of its respective longitudinal length, allowing the drugs or agents introduced into the fluid channel 112 to pass through the permeable portion of the channel 112 when a hydrostatic pressure inside the channel 122 is greater than a predetermined threshold, sueh as the pressure within the abdominal cavity.
- the permeable material may be a material selectively permeable to drugs and therapeutic agents,
- the permeable material can be configured into a membrane. Permeability could be controlled by the material composition, thereby allowing selective passage of drugs and therapeutic agents through the membrane based on pre-selected criteria, such as the molecular weight.
- the second lumen 202 of the catheter portion 200 is in fluid tight communication with, on one end, the fluid channel 112 of band member 110 and, at the other end, a second chamber 320 of the infusion port 300.
- Injection of drugs or a therapeutic agent into the second chamber 320 of the infusion port 300 allows the delivery of the drugs or therapeutic agents directly to the site of band portion 100 placement. This allows localized administration of drugs and therapeutic agents to the placement site of the gastric band, minimizing the total dosage of drugs or therapeutic agents required, if administered differently, and reducing the risk of systematic adverse reactions to the drugs or therapeutic agents.
- FIG. IA represents another feature of the infusion port 300 included in one embodiment of the present invention.
- the two chambers 310, 320 of the infusion port 300 are of different heights.
- the height difference of the two chambers 310, 320 is distinguishable by tactile examination.
- a physician can readily distinguish the two infusion ehambers 310, 320 by palpitation of the implant site without the aid of any other instrument.
- FIG. ID shows a side view of the band portion 100 of the present invention.
- FIG, IE shows a bottom view of the band portion 100 of the present invention.
- the segmented inflation bladder 120 aspeet of the present invention is shown.
- the inflatable bladder 120 is configured into several segments.
- a segmented inflatable bladder 120 ean expand to a greater degree than a eontinuous inflation bladder retaining the same amount of fluid.
- a segmented inflation bladder thereby provides a greater degree of post-surgical adjustment to the size of the stoma in the patient's stomaeh.
- Another advantage provided by a segmented bladder is that only the smooth, middle portion of eaeh segment eontaets the stomach. This avoids many possible pinch points and fold areas that would irritate the outer lining of the stomach, due to the lesser bladder contact area with the stomach.
Landscapes
- Health & Medical Sciences (AREA)
- Child & Adolescent Psychology (AREA)
- Obesity (AREA)
- Nursing (AREA)
- Orthopedic Medicine & Surgery (AREA)
- Engineering & Computer Science (AREA)
- Biomedical Technology (AREA)
- Heart & Thoracic Surgery (AREA)
- Vascular Medicine (AREA)
- Life Sciences & Earth Sciences (AREA)
- Animal Behavior & Ethology (AREA)
- General Health & Medical Sciences (AREA)
- Public Health (AREA)
- Veterinary Medicine (AREA)
- Surgical Instruments (AREA)
Abstract
Description
Claims
Priority Applications (3)
Application Number | Priority Date | Filing Date | Title |
---|---|---|---|
CA2713814A CA2713814C (en) | 2008-01-30 | 2009-01-30 | Gastric inflation band with integrated infusion catheter |
MX2010008392A MX2010008392A (en) | 2008-01-30 | 2009-01-30 | Gastric inflation band with integrated infusion catheter. |
EP09705609.7A EP2240091B1 (en) | 2008-01-30 | 2009-01-30 | Gastric inflation band with integrated infusion catheter |
Applications Claiming Priority (2)
Application Number | Priority Date | Filing Date | Title |
---|---|---|---|
US2460308P | 2008-01-30 | 2008-01-30 | |
US61/024,603 | 2008-01-30 |
Publications (1)
Publication Number | Publication Date |
---|---|
WO2009097482A1 true WO2009097482A1 (en) | 2009-08-06 |
Family
ID=40913250
Family Applications (1)
Application Number | Title | Priority Date | Filing Date |
---|---|---|---|
PCT/US2009/032536 WO2009097482A1 (en) | 2008-01-30 | 2009-01-30 | Gastric inflation band with integrated infusion catheter |
Country Status (5)
Country | Link |
---|---|
US (1) | US8425401B2 (en) |
EP (1) | EP2240091B1 (en) |
CA (1) | CA2713814C (en) |
MX (1) | MX2010008392A (en) |
WO (1) | WO2009097482A1 (en) |
Families Citing this family (64)
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US7338433B2 (en) | 2002-08-13 | 2008-03-04 | Allergan, Inc. | Remotely adjustable gastric banding method |
ES2617452T3 (en) | 2002-08-28 | 2017-06-19 | Apollo Endosurgery, Inc | Fatigue resistant gastric band device |
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US7871387B2 (en) | 2004-02-23 | 2011-01-18 | Tyco Healthcare Group Lp | Compression sleeve convertible in length |
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US8109892B2 (en) | 2007-04-09 | 2012-02-07 | Tyco Healthcare Group Lp | Methods of making compression device with improved evaporation |
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US8016778B2 (en) | 2007-04-09 | 2011-09-13 | Tyco Healthcare Group Lp | Compression device with improved moisture evaporation |
US8162861B2 (en) | 2007-04-09 | 2012-04-24 | Tyco Healthcare Group Lp | Compression device with strategic weld construction |
US8506508B2 (en) | 2007-04-09 | 2013-08-13 | Covidien Lp | Compression device having weld seam moisture transfer |
US8029450B2 (en) | 2007-04-09 | 2011-10-04 | Tyco Healthcare Group Lp | Breathable compression device |
US8114117B2 (en) | 2008-09-30 | 2012-02-14 | Tyco Healthcare Group Lp | Compression device with wear area |
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2009
- 2009-01-30 EP EP09705609.7A patent/EP2240091B1/en not_active Not-in-force
- 2009-01-30 WO PCT/US2009/032536 patent/WO2009097482A1/en active Application Filing
- 2009-01-30 CA CA2713814A patent/CA2713814C/en not_active Expired - Fee Related
- 2009-01-30 MX MX2010008392A patent/MX2010008392A/en active IP Right Grant
- 2009-01-30 US US12/362,680 patent/US8425401B2/en not_active Expired - Fee Related
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Also Published As
Publication number | Publication date |
---|---|
US20090198261A1 (en) | 2009-08-06 |
EP2240091A4 (en) | 2015-03-25 |
CA2713814A1 (en) | 2009-08-06 |
MX2010008392A (en) | 2010-11-05 |
CA2713814C (en) | 2014-09-02 |
EP2240091B1 (en) | 2016-07-20 |
EP2240091A1 (en) | 2010-10-20 |
US8425401B2 (en) | 2013-04-23 |
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