Intragastric device for treating obesity

• US 10,010,439 B2
• Filed: 04/20/2016
• Issued: 07/03/2018
• Est. Priority Date: 06/13/2010
• Status: Active Grant

• Current Assignee: SynerZ Medical, Inc.
• Original Assignee: SynerZ Medical, Inc.
• Inventors: Sharma, Virender K., Basude, Raghuveer
• Primary Examiner(s): LOUIS, RICHARD G
• Application Number:
  US15/134,288
• Publication Number:
  US 20170266027A1
• Time in Patent Office: 804 Days
• CPC Class Codes: A61B 17/12036 partial occlusion
• CPC Class Codes: A61B 17/12172 having a pre-set deployed three-dimensional shape methods of manufacturing A61B2017/00526
• CPC Class Codes: A61B 2017/00818 Treatment of the gastro-intestinal system
• CPC Class Codes: A61B 2017/1205 Introduction devices
• CPC Class Codes: A61B 6/12 Arrangements for detecting or locating foreign bodies
• 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 2002/9155 Adjacent bands being connected to each other
• CPC Class Codes: A61F 2220/0016 with sharp anchoring protrusions, e.g. barbs, pins, spikes
• CPC Class Codes: A61F 2230/0067 conical
• CPC Class Codes: A61F 2230/0071 spherical
• CPC Class Codes: A61F 5/0013 Implantable devices or invasive measures
• CPC Class Codes: A61F 5/0036 Intragastrical devices
• CPC Class Codes: A61F 5/0073 in the abdominal cavity, e.g. not attached to the stomach
• 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 25/0054 with regions for increasing flexibility
• CPC Class Codes: A61M 25/0068 Static characteristics of the catheter tip, e.g. shape, atraumatic tip, curved tip or tip structure
• 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
• CPC Class Codes: D04C 1/06 : Braid or lace serving particular purposes
• CPC Class Codes: D10B 2509/06 : Vascular grafts; stents

Abstract

An intragastric device including (1) a first wire mesh structure having a pre-deployment shape, a post-deployment shape greater than the pre-deployment state, and one or more openings on an upper portion of the first wire mesh structure that are configured to permit food to enter the device, (2) a second wire mesh structure having a pre-deployment shape a post-deployment shape greater than the pre-deployment state, and one or more openings on a lower portion of the second wire mesh structure that are configured to permit food to exit the device. A sleeve may be coupled to the lower portion of the wire mesh structure. An anti-migration collar may interconnect the wire mesh structure and the sleeve. In use, food enters the upper portion of the first wire mesh structure, passes through both wire mesh structures, and then exits the lower portion of the second wire mesh structure.

Claims

1. An intragastric device configured for deployment in a stomach of a person, said device comprising:

a catheter comprising a housing and a lumen extending through said housing, wherein the lumen has an internal diameter and wherein the internal diameter is equal to or less than 2 cm;

a first wire mesh structure having a pre-deployment shape that is compressed within said lumen of the catheter and a post-deployment shape that is expanded within the stomach of the person, wherein said pre-deployment shape has a first volume that is equal or less than 110 ml and a first length that is equal to or less than 75 cm and wherein said post-deployment shape has a porous, enclosed second volume, defined by a first plurality of curved surfaces, that is equal to or greater than 125 ml, said first wire mesh structure further comprising an upper portion and a lower portion wherein the upper portion has a first surface area of openings configured to permit material to enter from outside the second volume to inside the second volume and wherein the lower portion has a second surface area of openings;

a second wire mesh structure, separate from the first wire mesh structure, having a pre-deployment shape that is compressed within said lumen of the catheter and a post-deployment shape that is expanded within the stomach of the person, wherein said pre-deployment shape has a third volume that is equal or less than 100 ml and a second length that is equal to or less than 70 cm and wherein said post-deployment shape has a porous, enclosed fourth volume, defined by a second plurality of curved surfaces, that is equal to or greater than 110 ml, said second wire mesh structure further comprising an upper portion and a lower portion wherein the upper portion has a third surface area of openings configured to permit material to enter from outside the fourth volume to inside the fourth volume and wherein the lower portion has a fourth surface area of openings;

a connection to flexibly couple said first and second wire mesh structures, wherein said connection is formed between a portion of the first wire mesh structure defining said second surface area of openings and a portion of the second wire mesh structure defining said third surface area of openings,

wherein said connection is formed between a portion of a plurality of free ends of the first wire mesh structure defining said second surface area of openings and a portion of a plurality of free ends of the second wire mesh structure defining said third surface area of openings.

2. The intragastric device of claim 1 wherein the first wire mesh structure and the second wire mesh structure are positioned serially within the lumen of the catheter.

3. The intragastric device of claim 1 wherein at least one of the first plurality of curved surfaces is defined by an arc and wherein said arc is determined by a radius in a range of 0.2 cm to 20 cm and a central angle in a range of 5 to 175 degrees.

4. The intragastric device of claim 3 wherein at least one of the second plurality of curved surfaces is defined by an arc and wherein said arc is determined by a radius in a range of 0.1 cm to 15 cm and a central angle in, a range of 1 to 179 degrees.

5. The intragastric device of claim 1 wherein the first wire mesh structure has at least one of a spherical and elliptical shape.

6. The intragastric device of claim 5 wherein the second wire mesh structure has at least one of a spherical and elliptical shape.

7. The intragastric device of claim 1, wherein said first and second wire mesh structures have a degree of movement in all directions relative to each other, said degree of movement being defined by an angular displacement between a first longitudinal axis passing through a center of said first wire mesh structure, a center of the first surface area of openings, and a center of the second surface area of openings and a second longitudinal axis passing through a center of said second wire mesh structure, a center of the third surface area of openings and a center of the fourth surface area of openings.

8. The intragastric device of claim 7, wherein said angular displacement is equal to, or less than, 90 degrees.

9. The intragastric device of claim 1, wherein the connection of said first wire mesh structure to the second wire mesh structure has a length such that the first wire mesh structure can be compressed up to 99% of its equatorial diameter without leading to, a compression of said second wire mesh structure.

10. The intragastric device of claim 1, wherein the connection of said first wire mesh structure to the second wire mesh structure has a length such that, upon more than 90% compression of the first wire mesh structure, the second wire mesh structure has an angular displacement relative to the first wire mesh structure of 10% or less, wherein said angular displacement is defined by a relative angle between a first longitudinal axis passing through a center of said first wire mesh structure, a center of the first surface area of openings, and a center of the second surface area of openings and a second longitudinal axis passing through a center of said second wire mesh structure, a center of the third surface area of openings, and a center of the fourth surface area of openings.

11. The intragastric device of claim 1, wherein said first wire mesh structure and said second wire mesh structure are connected by said connection within the lumen of the catheter.

12. The intragastric device of claim 1, wherein said first wire mesh structure and said second wire mesh structure are not connected by said connection within the lumen of the catheter.

13. The intragastric device of claim 1, wherein said connection is formed by interweaving a portion of a plurality of free ends of said second surface area of openings and a portion of a plurality of free ends of said third surface area of openings.

14. The intragastric device of claim 1, wherein said second and fourth volumes together occupy 25% to 95% of the stomach.

15. The intragastric device of claim 1, further comprising a sleeve having a proximal end, a distal end, and a lumen, wherein said proximal end is coupled to said lower portion of said second wire mesh structure and said distal end is positioned in a duodenum of a patient, said sleeve further comprising a first opening in fluid communication with said fourth surface area of openings and a second opening at said distal end, wherein said sleeve is configured to transmit food from said intragastric device to said duodenum.

16. An intragastric device of claim 1, wherein said first wire mesh structure has at least one of a spherical shape and an elliptical shape and wherein said first wire mesh structure has a volume that is greater than 5 ml and less than 5000 ml.

17. An intragastric device of claim 16, wherein said second wire mesh structure has at least one of a spherical shape and an elliptical shape and wherein said second wire mesh structure has a volume that is greater than 20 ml and less than 4000 ml.

27. The intragastric device of claim 1, wherein each of the plurality of flexible members has a length such that, upon more than 90% compression of the first wire mesh structure, the second wire mesh structure has an angular displacement relative to the first wire mesh structure of 10% or less, wherein said angular displacement is defined by a relative angle between a first longitudinal axis passing through a center of said first wire mesh structure, a center of the first surface area of openings, and a center of the second surface area of openings and a second longitudinal axis passing through, a center of said second wire mesh structure, a center of the third surface area of openings, and a center of the fourth surface area of openings.

18. An intragastric device configured for deployment in a stomach of a person, said device comprising:

a first wire mesh structure having a pre-deployment shape that is compressed within a lumen of a catheter and a post-deployment shape that is expanded within the stomach of the person, wherein said pre-deployment shape has a first volume that is equal or less than 110 ml and a first length that is equal to or less than 75 cm and wherein said post-deployment shape has a porous, enclosed second volume, defined by a first plurality of curved surfaces, that is equal to or greater than 125 ml, said first wire mesh structure further comprising an upper portion and a lower portion wherein the upper portion has a first surface area of openings configured to permit material to enter from outside the second volume to inside the second volume and wherein the lower portion has a second surface area of openings;

a second wire mesh structure having a pre-deployment shape that is compressed within said lumen of the catheter and a post-deployment shape that is expanded within the stomach of the person, wherein said pre-deployment shape has a third volume that is equal or less than 100 ml and a second length that is equal to or less than 70 cm and wherein said post-deployment shape has a porous, enclosed fourth volume, defined by a second plurality of curved surfaces, that is equal to or greater than 110 ml, said first wire mesh structure further comprising an upper portion and a lower portion wherein the upper portion has a third surface area of openings configured to permit material to enter from outside the fourth volume to inside the fourth volume and wherein the lower portion has a fourth surface area of openings;

a plurality of flexible members to flexibly couple said first and second wire mesh structures, wherein said plurality of flexible members include a first flexible member attached, at one end, to a first point on said second surface area of openings and, at a second end, to a second point on said third surface area of openings and wherein said plurality of flexible members include a second flexible member attached, at one end, to a third point on said second surface area of openings and, at a second end, to a fourth point on said third surface area of openings, wherein said first point is different from the third point and wherein said second point is different from the fourth point,

wherein a length of said first flexible member, from the first point on the second surface area of openings to the second point on said third surface area of openings, is in a range of 0.01 mm and 300 mm, and

wherein a length of said second flexible member, from the third point on the second surface area of openings to the fourth point on said third surface area of openings, is in a range of 0.01 mm and 100 mm.

19. The intragastric device of claim 18, wherein the first flexible member and the second flexible member are separated by 180 degrees.

20. The intragastric device of claim 18, wherein said plurality of flexible members include a third flexible member attached, at one end, to a fifth point on said, second surface, area of openings and, at, a second end, to a sixth point on said third surface area of openings, wherein said fifth point is different from the first point and the third point and wherein said sixth point is different from the second point and the fourth point.

21. The intragastric device of claim 20, wherein a length of said third flexible member, from the fifth point on the second surface area of openings to the sixth point on said third surface area of openings, is in a range of 0.01 mm and 300 mm.

22. The intragastric device of claim 20, wherein said plurality of flexible members include a fourth flexible member attached, at one end, to a seventh point on said second surface area of openings and, at a second end, to a eighth point on said third surface area of openings, wherein said seventh point is different from the first point, the third point, and the fifth point and wherein said eighth point is different from the second point, the fourth point and the sixth point.

23. The intragastric device of claim 22, wherein a length of said fourth flexible member, from seventh point on the second surface area of openings to the eighth point on said third surface area of openings, is in a range of 0.01 mm and 100 mm.

24. The intragastric device of claim 18, wherein said first and second wire mesh structures have a degree of movement in all directions relative to each other, said degree of movement being defined by an angular displacement between a first longitudinal axis passing through a center of said first wire mesh structure, a center of the first surface area of openings, and a center of the second surface area of openings and a second longitudinal axis passing through a center of said second wire mesh structure, a center of the third surface area of openings, and a center of the fourth surface area of openings.

25. The intragastric device of claim 24, wherein said angular displacement is equal to, or less than, 90 degrees.

26. The intragastric device of claim 18, wherein each of the plurality of flexible members has a length such that the first wire mesh structure can be compressed up to 95% of its equatorial diameter without leading to a compression of said second wire mesh structure.

28. An intragastric device configured for deployment in a stomach of a person, said device comprising:

a catheter comprising a housing and a lumen extending through said housing, wherein the lumen has an internal diameter and wherein the internal diameter is equal to or less than 2 cm;

a first wire mesh structure having a pre-deployment shape that is compressed within said lumen of the catheter and a post-deployment shape that is expanded within the stomach of the person, wherein said pre-deployment shape has a first volume that is equal or less than 110 ml and a first length that is equal to or less than 75 cm and wherein said post-deployment shape has a porous, enclosed second volume, defined by a first plurality of curved surfaces, that is equal to or greater than 125 ml, said first wire mesh structure further comprising an upper portion and a lower portion wherein the upper portion has a first surface area of openings configured to permit material to enter from outside the second volume to inside the second volume and wherein the lower portion has a second surface area of openings;

a second wire mesh structure, separate from the first wire mesh structure, having a pre-deployment shape that is compressed within said lumen of the catheter and a post-deployment shape that is expanded within the stomach of the person, wherein said pre-deployment shape has a third volume that is equal or less than 100 ml and a second length that is equal to or less than 70 cm and wherein said post-deployment shape has a porous, enclosed fourth volume, defined by a second plurality of curved surfaces, that is equal to or greater than 110 ml, said second, wire mesh structure further comprising an upper portion and a lower portion wherein the upper portion has a third surface area of openings configured to permit material to enter from outside the fourth volume to inside the fourth volume and wherein the lower portion has a fourth surface area of openings;

at least one connection to flexibly couple said first and second wire mesh structures, wherein said connection is formed between a portion of the first wire mesh structure defining said second surface area of openings and a portion of the second wire mesh structure defining said third surface area of openings,

wherein at least one connection comprises a plurality of sutures.

29. The intragastric device of claim 28, wherein said plurality of sutures include a first flexible suture attached, at one end, to a first point on said second surface area of openings and, at a second end, to a second point on said third surface area of openings to form a first connection.

30. The intragastric device of claim 28, wherein a length of the first connection, from the first point on the second surface area of openings to the second point on said third surface area of openings, is in a range of 0.01 mm to 200 mm.

31. The intragastric device of claim 29, wherein said plurality of sutures include a second flexible suture attached, at one end, to a third point on said second surface area of openings and, at a second end, to a fourth point on said third surface area of openings to form a second connection, wherein said first point is different from the third point and wherein said second point is different from the fourth.

32. The intragastric device of claim 29, wherein a length of the second connection, from third point on the second surface area of openings to the fourth point on said third surface area of openings, is in a range of 0.01 mm and 300 mm.

33. The intragastric device of claim 29, wherein the first flexible suture and the second flexible suture are separated by 180 degrees.

34. The intragastric device of claim 29, wherein said plurality of sutures include a third flexible suture attached, at one end, to a fifth point on said second surface area of openings and, at a second end, to a sixth point on said third surface area of openings to form a third connection, wherein said, fifth point is different from the first point, and the third point and wherein said sixth point is different from the second point and the fourth point.

35. The intragastric device of claim 34, wherein a length of the third connection, from the fifth point on the second surface area of openings to the sixth point on said third surface area of openings, is in a range of 0.01 mm and 300 mm.

36. The intragastric device of claim 34, wherein said plurality of sutures include a fourth flexible suture attached, at one end, to a seventh point on said second surface area of openings and, at, a second end, to a eighth point on said third surface area of openings to form a fourth connection, wherein said seventh point is different from the first point, the third point, and the fifth point and wherein said eighth point is different from the second point, the fourth point and the sixth point.

37. The intragastric device of claim 36, wherein a length of the fourth connection, from seventh point on the second surface area of openings to the eighth point on said third surface area of openings, is in a range of 0.01 mm and 300 mm.

38. An intragastric device configured for deployment in a stomach of a person, said device comprising:

a catheter comprising a housing and a lumen extending through said housing, wherein the lumen has an internal diameter and wherein the internal diameter is equal to or less than 2 cm;

a first wire mesh structure having a pre-deployment shape that is compressed within said lumen of the catheter and a post-deployment shape that is expanded within the stomach of the person, wherein said pre-deployment shape has a first volume that is equal or less than 110 ml and a first length that is equal to or less than 75 cm and wherein said post-deployment shape has a porous, enclosed second volume, defined by a first plurality of curved surfaces, that is equal to or greater than 125 ml, said first wire mesh structure further comprising an upper portion and a lower portion wherein the upper portion has a first surface area of openings configured to permit material to enter from outside the second volume to inside the second volume and wherein the lower portion has a second surface area of openings;

a second wire mesh structure, separate, from the first wire mesh structure, having a pre-deployment shape that is compressed within said lumen of the catheter and a post-deployment shape that is expanded within the stomach of the person, wherein said pre-deployment shape has a third volume that is equal or less than 100 ml and a second length that is equal to or less than 70 cm and wherein said post-deployment shape has a porous, enclosed fourth volume, defined by a second plurality of curved surfaces, that is equal to or greater than 110 ml, said second wire mesh structure further comprising an upper portion and a lower portion wherein the upper portion has a third surface area of openings configured to permit material to enter from outside the fourth volume to inside the fourth volume and wherein the lower portion has a fourth surface area of openings;

a connection to flexibly couple said first and second wire mesh structures, wherein said connection is formed between a portion of the first wire mesh structure defining said second surface area of openings and a portion of the second wire mesh structure defining said third surface area of openings,

wherein said connection is formed by interweaving a portion of a plurality of free ends of said second surface area of openings and a portion of a plurality of free ends of said third surface area of openings.

39. An intragastric device configured for deployment in a stomach of a person, said device comprising:

a catheter comprising a housing and a lumen extending through said housing, wherein the lumen has an internal diameter and wherein the internal diameter is equal to or less than 2 cm;

a first wire mesh structure having a pre-deployment shape that is compressed within said lumen of the catheter and a post-deployment shape that is expanded within the stomach of the person, wherein said pre-deployment, shape has a first volume that is equal or less than 110 ml and a first length that is equal to or less than 75 cm and wherein said post-deployment shape has a porous, enclosed second volume, defined by a first plurality of curved surfaces, that is equal to or greater than 125 ml, said first wire mesh structure further comprising an upper portion and a lower portion wherein the upper portion has a first surface area of openings configured to permit material to enter from outside the second volume to inside the second volume and wherein the lower portion has a second surface area of openings;

a second wire mesh structure, separate from the first wire mesh structure, having a pre-deployment shape that is compressed within said lumen of the catheter and a post-deployment shape that is expanded within the stomach of the person, wherein said pre-deployment shape has a third volume that is equal or less than 100 ml and a second length that is equal to or less than 70 cm and wherein said post-deployment shape has a porous, enclosed fourth volume, defined by a second plurality of curved surfaces, that is equal to or greater than 110 ml, said second wire mesh structure further comprising an upper portion and a lower portion wherein the upper portion has a third surface area of openings configured to permit material to enter from outside the fourth volume to inside the fourth volume and wherein the lower portion has a fourth surface area of openings;

a connection to flexibly couple said first and second wire mesh structures, wherein, said connection is formed between, a portion of the first wire mesh structure defining said second surface area of openings and a portion of the second wire mesh structure defining said third surface area of openings,

further comprising a sleeve having a proximal end, a distal end, and a lumen, wherein said proximal end is coupled to said lower portion of said second wire mesh structure and said distal end is positioned in a duodenum of a patient, said sleeve further comprising a first opening in fluid communication with said fourth surface area of openings and a second opening at said distal end, wherein said sleeve is configured to transmit food from said intragastric device to said duodenum.

40. An intragastric device configured for deployment in a stomach of a person, said device comprising:

a first wire mesh structure having a pre-deployment shape that is compressed within a lumen of a catheter and a post-deployment shape that is expanded within the stomach of the person, wherein said pre-deployment shape has a first volume that is equal or less than 110 ml and a first length that is equal to or less than 75 cm and wherein said post-deployment shape has a porous, enclosed second volume, defined by a first plurality of curved surfaces, that is equal to or greater than 125 ml, said first wire mesh structure further comprising an upper portion and a lower portion wherein the upper portion has a first surface area of openings configured to permit material to enter from outside the second volume to inside the second volume and wherein the lower portion has a second surface area of openings;

a second wire mesh structure having a pre-deployment shape that is compressed within said lumen of the catheter and a post-deployment shape that is expanded within the stomach of the person, wherein said pre-deployment shape has a third volume that is equal or less than 100 ml and a second length that is equal to or less than 70 cm and wherein said post-deployment shape has a porous, enclosed fourth volume, defined by a second plurality of curved surfaces, that is equal to or greater than 110 ml, said first wire mesh structure further comprising an upper portion and a lower portion wherein the upper portion has a third surface area of openings, configured to permit material to enter from outside the fourth volume to inside the fourth volume and wherein the lower portion has a fourth surface area of openings;

a plurality of flexible members to flexibly couple said first and second wire mesh structures, wherein said plurality of flexible members include a first flexible member attached, at one end, to a first point on said second surface area of openings and, at a second end, to a second point on said third surface area of openings and wherein said plurality of flexible members include a second flexible member attached, at one end, to a third point on said second surface area of openings and, at a second end, to a fourth point on said third surface area of openings, wherein said first point is different from the third point and wherein said second point is different from the fourth point,

wherein each of the plurality of flexible members has a length such that the first wire mesh structure can be compressed up to 95% of its equatorial diameter without leading to a compression of said second wire mesh structure.

41. An intragastric device configured for deployment in a stomach of a person, said device comprising:

a first wire mesh structure having a pre-deployment shape that is compressed within a lumen of a catheter and a post-deployment shape that is expanded within the stomach of the person, wherein said pre-deployment shape has a first volume that is equal or less than 110 ml and a first length that is equal to or less than 75 cm and wherein said post-deployment shape has a porous, enclosed second volume, defined by a first plurality of curved surfaces, that is equal to or greater than 125 ml, said first wire mesh structure further comprising an upper portion and a lower portion wherein the upper portion has a first surface area of openings configured to permit material to enter from outside the second volume to inside the second, volume and wherein the lower portion has a second surface area of openings;

a second wire mesh structure having a pre-deployment shape that is compressed within said lumen of the catheter and a post-deployment shape that is expanded within the stomach of the person, wherein said pre-deployment shape has a third volume that is equal or less than 100 ml and a second length that is equal to or less than 70 cm and wherein said post-deployment shape has a porous, enclosed fourth volume, defined by a second plurality of curved surfaces, that is equal to or, greater than 110 ml, said first wire mesh structure further comprising an upper portion and a lower portion wherein the upper portion has a third surface area of openings configured to permit material to enter from outside the fourth volume to inside the fourth volume and wherein the lower portion has a fourth surface area of openings;

a plurality of flexible members to flexibly couple said first and second wire mesh structures, wherein said plurality of flexible members include a first flexible member attached, at one end, to a first point on said second surface area of openings and, at, a second end, to a second point on said third surface area of openings and wherein said plurality of flexible members include a second flexible member attached, at one end, to a third point on said second surface area of openings and, at a second end, to a fourth point on said third surface area of openings, wherein said first point is different from the third point and wherein said second point is different from the fourth point,

wherein each of the plurality of flexible members has a length such that, upon more than 90% compression of the first wire mesh structure, the second wire mesh structure has an angular displacement relative to the first wire mesh structure of 10% or less, wherein said angular displacement is defined by a relative angle between a first longitudinal axis passing through a center of said first wire mesh structure, a center of the first surface area of openings, and a center of the second surface area of openings and a second longitudinal axis passing through a center of said second wire mesh structure, a center of the third surface area of openings, and a center of the fourth surface area of openings.