Anchors and methods for intestinal bypass sleeves

• US 9,278,019 B2
• Filed: 01/28/2012
• Issued: 03/08/2016
• Est. Priority Date: 04/03/2009
• Status: Active Grant

• Current Assignee: MetaModix, Inc.
• Original Assignee: MetaModix, Inc.
• Inventors: Thompson, Paul J., Belhe, Kedar R., Grafov, Alexander D.
• Primary Examiner(s): Wiest, Philip R
• Application Number:
  US13/360,689
• Publication Number:
  US 20120184893A1
• Time in Patent Office: 1,501 Days
• Field of Search: 604 8- 10, 604/154, 604/192, 623 2364- 237
• US Class Current: 1/1
• 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 2/24 Heart valves ; Vascular valves, e.g. venous valves; Heart implants, e.g. passive devices for improving the function of the native valve or the heart muscle; Transmyocardial revascularisation [TMR] devices; Valves implantable in the body
• CPC Class Codes: A61F 2/2476 Valves implantable in the body not otherwise provided for
• CPC Class Codes: A61F 2002/044 Oesophagi or esophagi or gullets
• CPC Class Codes: A61F 2002/045 Stomach, intestines
• CPC Class Codes: A61F 2220/0008 Fixation appliances for connecting prostheses to the body
• 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

Abstract

A gastrointestinal device for implanting within a pylorus, a duodenal bulb, and a duodenum of a patient'"'"'s gastrointestinal tract includes an expandable structure including a proximal portion having a plurality of spring arms and a distal portion having a plurality of spring arms, the proximal and distal portions coupled by a rigid central cylinder having a diameter capable of fitting within the pylorus and having a length greater than a width of the pylorus. An intestinal bypass sleeve is coupled to at least one of the proximal and distal portions of the expandable structure and having a length sufficient to extend at least partially into the duodenum. In the expanded configuration, the proximal portion has a diameter larger than a maximum opening diameter of the pylorus and further wherein, in the expanded configuration, the distal portion has a diameter larger than a maximum opening diameter of the pylorus.

Claims

1. A gastrointestinal device for implanting within a pylorus, a duodenal bulb, and a duodenum of a patient'"'"'s gastrointestinal tract, the device configured to have an expanded configuration and a contracted configuration, the device comprising:

an expandable structure including a proximal portion having a first diameter in the expanded configuration that is configured for engaging a first wall of the pylorus at a first location adjacent the pyloric antrum and having a coil compression spring, and a distal portion having a second diameter in the expanded configuration that is configured for engaging a second wall of the pylorus at a second location adjacent the duodenal bulb and having a coil compression spring, the proximal and distal portions coupled by a central cylinder portion having a third diameter in the expanded configuration that is less than the first diameter and less than the second diameter but equal to or larger than a maximum diameter of the pylorus such that the central cylinder portion does not restrict flow through the pylorus and has a length greater than a width of the pylorus, wherein the coil compression springs of the proximal and the distal portions extend radially outward to the first and second diameters, respectively, and extend circumferentially around the central cylinder;

a membrane coupled to and covering at least a portion of one of the proximal portion and the distal portion of the expandable structure; and

an intestinal bypass sleeve coupled to at least one of the proximal and distal portions of the expandable structure and having a length sufficient to extend at least partially into the duodenum;

wherein, in the expanded configuration, the proximal portion has a diameter larger than a maximum opening diameter of the pylorus and wherein, in the expanded configuration, the distal portion has a diameter larger than a maximum opening diameter of the pylorus, and further wherein the proximal and distal portions are spaced apart at discrete locations along the central cylinder.

2. The gastrointestinal device of claim 1 wherein at least one of the proximal portion and the distal portion of the expandable structure is a disk-shaped element.

3. The gastrointestinal device of claim 1 wherein at least one of the coil compression springs of the proximal portion and the distal portion of the expandable structure has a shape selected from one or more of the following:

a toroidal-shaped element, a spherical-shaped element, and a cylindrical-shaped element.

4. The gastrointestinal device of claim 1 wherein the central cylinder portion has an anti-reflux valve adapted for preventing reflux of the duodenal contents back into the stomach.

5. The gastrointestinal device of claim 1 further including a supplemental securement mechanism for securing the device to the pylorus or the stomach, the supplemental securement mechanism including one or more of the following:

a suture, a T-bar, a hook, a barb and a screw-type anchor.

6. The gastrointestinal device of claim 1 wherein the intestinal bypass sleeve has a length sufficient to extend at least partially into a jejunum of the patient'"'"'s gastrointestinal tract.

7. A gastrointestinal device for treatment of gastroparesis, the device configured to have an expanded configuration and a contracted configuration, the device comprising:

an expandable structure including a proximal portion having a first diameter in the expanded configuration that is configured for engaging a first wall of the pylorus at a first location adjacent the pyloric antrum and having a coil compression spring, and a distal portion having a second diameter in the expanded configuration that is configured for engaging a second wall of the pylorus at a second location adjacent the duodenal bulb and having a coil compression spring, the proximal and distal portions coupled by a central cylinder having a third diameter in the expanded configuration that is less than the first diameter and less than the second diameter but equal to or larger than a maximum diameter of the pylorus such that the central cylinder portion does not restrict flow through the pylorus, wherein the coil compression springs of the proximal and the distal portions extend radially outward to the first and second diameters, respectively, and extend circumferentially around the central cylinder;

a membrane coupled to and covering at least a portion of one of the proximal portion and the distal portion of the expandable structure; and

a pump device adapted for coupling at least partially within the central cylinder portion, the pump device adapted to pump chyme from a stomach, through the pylorus, to a duodenum;

wherein, in the expanded configuration, the proximal portion has a diameter larger than a maximum opening diameter of the pylorus and wherein, in the expanded configuration, the distal portion has a diameter larger than a maximum opening diameter of the pylorus, and further wherein the proximal and distal portions are spaced apart at discrete locations along the central cylinder.

8. The gastrointestinal device of claim 7 wherein at least one of the proximal portion and the distal portion of the expandable structure is a disk-shaped element.

9. The gastrointestinal device of claim 7 wherein at least one of the coil compression springs has a shape selected from one or more of the following:

a toroidal-shaped element, a spherical-shaped element, and a cylindrical-shaped element.

10. The gastrointestinal device of claim 7 wherein the central cylinder portion has an anti-reflux valve adapted for preventing reflux of the duodenal contents back into the stomach.

11. The gastrointestinal device of claim 7 further including a supplemental securement mechanism for securing the device to the pylorus or the stomach, the supplemental securement mechanism including one or more of the following:

a suture, a T-bar, a hook, a barb and a screw-type anchor.

12. The gastrointestinal device of claim 7 further comprising an intestinal bypass sleeve coupled to at least one of the proximal and distal portions of the expandable structure and having a length sufficient to extend at least partially into the jejunum.

14. The gastrointestinal device of claim 12 wherein at least one of the proximal portion and the distal portion of the expandable structure is a disk-shaped element.

15. The gastrointestinal device of claim 12 wherein at least one of the coil compression springs has a shape selected from one or more of the following:

a toroidal-shaped element, a spherical-shaped element, and a cylindrical-shaped element.

16. The gastrointestinal device of claim 12 wherein the central cylinder portion has an anti-reflux valve adapted for preventing reflux of the duodenal contents back into the stomach.

17. The gastrointestinal device of claim 12 further including a supplemental securement mechanism for securing the device to the pylorus or the stomach, the supplemental securement mechanism including one or more of the following:

a suture, a T-bar, a hook, a barb and a screw-type anchor.

13. A gastrointestinal device for implanting within a pylorus, a duodenal bulb, and a duodenum of a patient'"'"'s gastrointestinal tract, the device configured to have an expanded configuration and a contracted configuration, the device comprising:

an expandable structure including a proximal portion having a first diameter in the expanded configuration that is configured for engaging a first wall of the pylorus at a first location adjacent the pyloric antrum and having a coil compression spring, and a distal portion having a second diameter in the expanded configuration that is configured for engaging a second wall of the pylorus at a second location adjacent the duodenal bulb and having a coil compression spring, the proximal and distal portions coupled by a central cylinder portion having a third diameter in the expanded configuration that is less than the first diameter and less than the second diameter but equal to or larger than a maximum diameter of the pylorus such that the central cylinder portion does not restrict flow through the pylorus and having a length less than a width of the pylorus so as to enable the expandable structure to exert a compressive force on the pylorus, wherein the coil compression springs of the proximal and the distal portions extend radially outward to the first and second diameters, respectively, and extend circumferentially around the central cylinder;

an intestinal bypass sleeve coupled to at least one of the proximal and distal portions of the expandable structure and having a length sufficient to extend at least partially into the duodenum; and

an anti-reflux valve coupled to the central cylinder and adapted to close one end of the bypass sleeve;

wherein, in the expanded configuration, the proximal portion has a diameter larger than a maximum opening diameter of the pylorus and wherein, in the expanded configuration, the distal portion has a diameter larger than a maximum opening diameter of the pylorus, and further wherein the proximal and distal portions are spaced apart at discrete locations along the central cylinder.