Intragastric device for treating obesity

• US 10,420,665 B2
• Filed: 09/23/2015
• Issued: 09/24/2019
• Est. Priority Date: 06/13/2010
• Status: Active Grant

• Current Assignee: SynerZ Medical, Inc.
• Original Assignee: W. L. Gore & Associates (W.L. Gore & Associates)
• Inventors: Sharma, Virender K., Basude, Raghuveer
• Primary Examiner(s): Rodjom, Katherine M
• Application Number:
  US14/862,706
• Publication Number:
  US 20160095733A1
• Time in Patent Office: 1,462 Days
• CPC Class Codes: A61B 6/12 Arrangements for detecting or locating foreign bodies
• CPC Class Codes: A61B 6/485 involving fluorescence X-ray imaging
• CPC Class Codes: A61F 2/04 Hollow or tubular parts of organs, e.g. bladders, tracheae, bronchi or bile ducts A61F2/18, A61F2/20 take precedence; devices, other than stent-grafts, providing patency to, or preventing collapsing of, tubular structures of the body other than stent-grafts, e.g. stents A61F2/82; instruments specially adapted for placement or removal of stents or stent-grafts A61F2/95
• CPC Class Codes: A61F 2002/045 Stomach, intestines
• CPC Class Codes: A61F 2230/0071 spherical
• CPC Class Codes: A61F 5/0036 Intragastrical devices
• CPC Class Codes: A61F 5/0076 preventing normal digestion, e.g. Bariatric or gastric sleeves
• CPC Class Codes: A61F 5/0079 Pyloric or esophageal obstructions
• CPC Class Codes: A61F 5/0089 Instruments for placement or removal
• CPC Class Codes: A61M 2025/0004 having two or more concentrically arranged tubes for forming a concentric catheter system
• CPC Class Codes: A61M 25/0108 using radio-opaque or ultrasound markers
• CPC Class Codes: A61M 25/0136 Handles therefor
• CPC Class Codes: A61M 25/09 Guide wires

Abstract

A gastrointestinal device for treating obesity includes a three-dimensional porous structure configurable between a compressed pre-deployment configuration to facilitate delivery and an expanded post-deployment configuration. The porous structure includes a first opening at its proximal end and a larger second opening at its distal end. The porous structure also includes a sleeve coupled to its distal end. Optionally, the device further includes a suture at the proximal end of the wire mesh structure to facilitate retrieval and an anti-migration component positioned at the junction of the porous structure with the sleeve. The porous structure is deployed in a patient'"'"'s stomach such that the anti-migration component sits proximal to the patient'"'"'s pylorus and prevents migration of the entirety of the device into and through the pylorus. The sleeve extends through the pylorus, into the duodenum and ends in the duodenum or jejunum. Food enters the device from the first opening at the proximal end of the porous structure, passes through the porous structure and sleeve, and exits at the distal end of the sleeve. The device treats obesity by providing a relatively immovable volume occupying structure in the stomach and a bypass for food past the pylorus and proximal portion of the small intestine. Optionally, the device further acts to slow the passage of food through the digestive tract. Patients with the device experience satiety more quickly and have a prolonged sensation of satiety.

Claims

1. A delivery device for delivering a gastrointestinal device into a gastrointestinal tract of a patient, said gastrointestinal device comprising a porous structure configurable between a compressed pre-deployment configuration and an expanded post-deployment configuration, an anti-migration collar proximate a distal end of said porous structure, and an elongate sleeve coupled to the distal end of said porous structure, said delivery device comprising:

a flexible outer catheter having a proximal end, a distal end, and a lumen;

a flexible inner catheter having a proximal end, a distal end, and a lumen configured to slidably receive a guide wire, wherein said inner catheter is positioned coaxially and is configured to be slidably movable within the lumen of said outer catheter;

wherein said outer catheter is configured to be retracted in a proximal direction over said inner catheter while maintaining said inner catheter in place to expose said gastrointestinal device from said distal end of said delivery device;

a first handle attached to the proximal end of said inner catheter and having a proximal end, a distal end, and a lumen configured to slidably receive said guide wire;

a second handle attached to the proximal end of said outer catheter and having a proximal end, a distal end, and a lumen configured to slidably receive said inner catheter, wherein, prior to delivery of said intragastric device, a proximal portion of said inner catheter positioned between said first and second handles is exposed and not covered by said outer catheter;

an elongate flexible pilot component having a proximal end, a distal end and a length having a variable stiffness, said pilot component comprising a distal spherical component and a proximal spherical component and extending from said distal end of said inner catheter;

a first stopping mechanism removably attached to said exposed portion of said inner catheter; and

a second stopping mechanism removably attached to said exposed portion of said inner catheter and positioned proximal to said first stopping mechanism;

wherein said first and second stopping mechanisms are configured to be sequentially removed from said inner catheter as said outer catheter is retracted.

2. The delivery device of claim 1, wherein said sleeve has length such that, once said gastrointestinal device is delivered, a proximal end of said sleeve is positioned proximal to a patient'"'"'s pylorus and a distal end of said sleeve is positioned in a portion of a patient'"'"'s duodenum.

3. The delivery device of claim 1, wherein said outer catheter has a length of approximately 1.5 meters and said delivery device has an overall length of approximately 3 meters.

4. The delivery device of claim 1, further comprising a hydrophilic coating over at least one of said pilot component and said distal end of said outer catheter, wherein, when activated, said hydrophilic coating is adapted to ease insertion and navigation of said delivery device.

5. The delivery device of claim 1, further comprising a port on at least one of said first handle for injecting a fluid into said lumen of said inner catheter and said second handle for injecting a fluid into said lumen of said outer catheter.

6. The delivery device of claim 1, wherein said proximal spherical component is configured to be atraumatic and includes a radiopaque marker for radiographic visualization during delivery.

7. The delivery device of claim 1, wherein said distal spherical component is configured in an atraumatic ball-tip shape.

8. The delivery device of claim 1, wherein said variable stiffness of said pilot component is less than a stiffness of said distal end of said outer catheter at its proximal end and similar to a stiffness of a 0.035 inch guide wire at its distal end.

9. A delivery system for delivering a gastrointestinal device into a gastrointestinal tract of a patient, said system comprising:

a gastrointestinal device comprising;

a porous structure configurable between a compressed pre-deployment configuration and an expanded post-deployment configuration;

an anti-migration collar proximate a distal end of said porous structure; and

an elongate sleeve coupled to a distal end of said porous structure;

a delivery device comprising;

a flexible outer catheter having a proximal end, a distal end, and a lumen;

a flexible inner catheter having a proximal end, a distal end, and a lumen configured to slidably receive a guide wire, wherein said inner catheter is positioned coaxially and is adapted to be slidably movable within the lumen of said outer catheter;

a first handle attached to the proximal end of said inner catheter and having a proximal end, a distal end, and a lumen configured to slidably receive said guide wire;

a second handle attached to the proximal end of said outer catheter and having a proximal end, a distal end, and a lumen configured to slidably receive said inner catheter, wherein a proximal portion of said inner catheter positioned between said first and second handles is not covered in its entirety by said outer catheter;

an elongate flexible component comprising a distal spherical component and a proximal spherical component and extending from said distal end of said inner catheter;

a first stopping mechanism removably attached to said exposed portion of said inner catheter;

a second stopping mechanism removably attached to said exposed portion of said inner catheter and positioned proximal to said first stopping mechanism;

wherein said distal end of said inner catheter is adapted to be passed through openings of said porous structure, wherein said sleeve is wrapped coaxially about said inner catheter, wherein said outer catheter may be retracted in a proximal direction over said inner catheter while maintaining said inner catheter in place, and wherein said first and second stopping mechanisms are adapted to be sequentially removed from said inner catheter as said outer catheter is retracted to expose and deliver the gastrointestinal device from said distal end of said delivery device.

10. The delivery system of claim 9, further comprising a hydrophilic coating over at least one of said elongate flexible component and said distal end of said outer catheter, wherein, when said hydrophilic coating is activated, the hydrophilic coating eases insertion and navigation of said delivery device.

11. The delivery system of claim 9, further comprising a port on at least one of said first handle for injecting a fluid into said lumen of said inner catheter and said second handle for injecting a fluid into said lumen of said outer catheter.

12. The delivery system of claim 9, wherein said delivery device has a variable stiffness along its length.