High specific gravity intragastric device

US 8,758,385 B2
Filed: 12/22/2009
Issued: 06/24/2014
Est. Priority Date: 12/27/2008
Status: Active Grant

First Claim

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1. An untethered, high specific gravity, antrum-based, intragastric device, comprising:

a single expandable casing having a biocompatible outer surface and, upon expansion, a predetermined shape for contacting the antrum of the stomach of a subject;

wherein,the expanded casing hasa minimum, cross-sectional dimension of at least about 40 mm during operation of the device in the subject to avoid passage of any portion of the device through the lower esophageal sphincter or pyloric sphincter of the subject after expansion, limiting the intragastric device to a minimum volume of π

(40 mm)³/6 or about 33 ml;

a maximum, cross-sectional dimension of the predetermined shape of about 70 mm for a positioning of the predetermined shape in the pyloric antrum of the subject, limiting the intragastric device to a maximum volume of π

(70 mm)³/6 or about 180 ml;

and,a high specific gravity material, wherein the high specific gravity material has a specific gravity that is greater than 1.2 and contributes to an in vivo specific gravity of the device that ranges from about 1.2 to about 2.1, wherein the specific gravity functions to direct the device to the pyloric antrum of the subject to induce gastric discomfort during use of the device;

wherein, the specific gravity of the device allows the device to move freely about the distal stomach and apply pressure to the antrum without otherwise affecting normal gastric function of the subject.

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Abstract

The teachings are directed to an intragastric device comprising a flexible and expandable bladder having a predetermined shape upon expansion for contacting the antrum of the stomach of a subject. The device is designed to avoid passage of any part of the device beyond the pylorus and lower esophageal sphincter while the bladder is expanded during use. In these embodiments, the bladder can contain a high specific gravity material when expanded; wherein, the high specific gravity material contributes to an in vivo specific gravity of the device that ranges from about 1.2 g/ml to about 2.1 g/ml and functions to direct the device to the pyloric antrum of the subject during use of the device. Moreover, these embodiments can include a filling material comprising a biocompatible fluid component and a hydrogel component to make the device substantially leakproof and contribute to the in vivo specific gravity of the device.

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71 Claims

1. An untethered, high specific gravity, antrum-based, intragastric device, comprising:
- a single expandable casing having a biocompatible outer surface and, upon expansion, a predetermined shape for contacting the antrum of the stomach of a subject;
  
  wherein,the expanded casing hasa minimum, cross-sectional dimension of at least about 40 mm during operation of the device in the subject to avoid passage of any portion of the device through the lower esophageal sphincter or pyloric sphincter of the subject after expansion, limiting the intragastric device to a minimum volume of π
  
  (40 mm)³/6 or about 33 ml;
  
  a maximum, cross-sectional dimension of the predetermined shape of about 70 mm for a positioning of the predetermined shape in the pyloric antrum of the subject, limiting the intragastric device to a maximum volume of π
  
  (70 mm)³/6 or about 180 ml;
  
  and,a high specific gravity material, wherein the high specific gravity material has a specific gravity that is greater than 1.2 and contributes to an in vivo specific gravity of the device that ranges from about 1.2 to about 2.1, wherein the specific gravity functions to direct the device to the pyloric antrum of the subject to induce gastric discomfort during use of the device;
  
  wherein, the specific gravity of the device allows the device to move freely about the distal stomach and apply pressure to the antrum without otherwise affecting normal gastric function of the subject.
- View Dependent Claims (2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14, 15, 16, 17, 18, 19, 20, 21, 22, 23, 24, 25, 26)
- - 2. The device of claim 1, wherein the casing comprises the high specific gravity material.
  - 3. The device of claim 1, wherein the outer surface of the casing comprises the high specific gravity material.
  - 4. The device of claim 1, wherein the casing encloses an inner compartment and has a sealable port in communication with the inner compartment for administering a fluid and expanding the casing in the stomach of a subject.
  - 5. The device of claim 4, wherein the inner compartment contains the high specific gravity material.
  - 6. The device of claim 4, wherein the inner compartment contains the high specific gravity material, and the high specific gravity material is integrated with the casing.
  - 7. The device of claim 1, wherein the high specific gravity material comprises a biocompatible fluid.
  - 8. The device of claim 1, wherein the high specific gravity material comprises a biocompatible fluid selected from the group consisting of a salt solution, a sugar solution, honey, a sugar alcohol solution, glycerin, or a combination thereof.
  - 9. The device of claim 1, wherein the high specific gravity material comprises a sugar alcohol solution.
  - 10. The device of claim 1, wherein the high specific gravity material comprises a solid component.
  - 11. The device of claim 1, wherein the high specific gravity material comprises a solid component, and an expansion of the solid component contributes to expansion of the casing.
  - 12. The device of claim 1, wherein the high specific gravity material comprises a solid component that is hygroscopic.
  - 13. The device of claim 1, wherein the high specific gravity material comprises a hydrogel.
  - 14. The device of claim 1, wherein the high specific gravity material comprises a biocompatible solid selected from the group consisting of a metal, a salt, a heavy polymer or a combination thereof.
  - 15. The device of claim 1, wherein the device has an in vivo specific gravity ranging from about 1.2 to about 1.5.
  - 16. The device of claim 1, wherein the device has an in vivo specific gravity ranging from about 1.2 to about 1.3.
  - 17. The device of claim 1, wherein the device has an in vivo specific gravity ranging from about 1.3 to about 1.6.
  - 18. The device of claim 1, wherein a portion of the outer surface is compliant or substantially compliant with a surface of the antrum and has a durometer of at least about Shore 40A.
  - 19. The device of claim 1, wherein, the predetermined shape is designed to apply a pressure to the antrum to satiate hunger in the subject.
  - 20. The device of claim 1, wherein the expanded casing contains an antimicrobial agent.
  - 21. The device of claim 1, wherein at least a portion of the outer surface is composed of a material comprising a gastric-acid resistant material.
  - 22. The device of claim 1, wherein the casing comprises an ultrasonically visible marker for ultrasonically monitoring the device in vivo.
  - 23. A method of administering the device of claim 1, comprising:
    - placing the device in a collapsed state in the stomach of the subject; and
      
      ,expanding the device after the placing;
      
      wherein,the high specific gravity functions to direct the device to the antrum of the stomach.
  - 24. A method of treating obesity in a subject using the device of claim 1, wherein the method comprises:
    - placing the device in a collapsed state in the stomach of the subject;
      
      expanding the device; and
      
      ,treating the subject for an effective amount of time.
  - 25. The method of claim 24, wherein, the treating includes a deployment period of at least 9 months.
  - 26. A kit comprising the device of claim 1, a filling material having a specific gravity of greater than 1.2, and an insertion catheter designed for administration of the device in the subject.

27. An intragastric device, comprising:
- a single flexible and expandable bladder having a biocompatible outer surface and, upon expansion, a predetermined shape for contacting the antrum of the stomach of a subject; and
  
  ,a means for expanding the bladder in vivo;
  
  wherein,the flexible bladder hasa diameter upon expansion that ranges from about 40 mm to about 70 mm, limiting the intragastric device to a minimum volume of π
  
  (40 mm)³/6 or about 33 ml and a maximum volume of π
  
  (70 mm)³/6 or about 180 ml; and
  
  ,a high specific gravity material, wherein the high specific gravity material has a specific gravity that is greater than 1.2 and contributes to an in vivo specific gravity of the device that ranges from about 1.2 to about 2.1 and functions to direct the device to the pyloric antrum of the subject to induce gastric discomfort during use of the device;
  
  wherein, the specific gravity of the device allows the device to move freely about the distal stomach and apply pressure to the antrum without otherwise affecting normal gastric function of the subject.
- View Dependent Claims (28, 29, 30, 31, 32, 33, 34, 35, 36)
- - 28. The device of claim 27, wherein the bladder has a predetermined shape designed to apply a pressure to the pyloric antrum to satiate hunger in the subject.
  - 29. The device of claim 27, wherein the device has an in vivo specific gravity ranging from about 1.3 to about 1.6.
  - 30. The device of claim 27, wherein the device has an in vivo specific gravity ranging from about 1.2 to about 1.3.
  - 31. The device of claim 27, wherein a portion of the outer surface is compliant or substantially compliant with a surface of the antrum and has a durometer of at least about Shore 40A.
  - 32. The device of claim 27, wherein the casing comprises an ultrasonically visible marker for ultrasonically monitoring the device in vivo.
  - 33. A method of administering the device of claim 27, comprising:
    - placing the device in a collapsed state in the stomach of the subject; and
      
      ,expanding the device after the placing;
      
      wherein,the high specific gravity functions to direct the device to the antrum of the stomach.
  - 34. A method of treating obesity in a subject using the device of claim 27, wherein the method comprises:
    - placing the device in a collapsed state in the stomach of the subject;
      
      expanding the device; and
      
      ,treating the subject for an effective amount of time.
  - 35. The method of claim 34, wherein, the treating includes a deployment period of at least 9 months.
  - 36. A kit comprising the device of claim 27, a filling material having a specific gravity of greater than 1.2, and an insertion catheter designed for administration of the device in the subject.

37. An untethered, high specific gravity, hydrogel-containing, intragastric device that is at least substantially leakproof, wherein the device comprises:
- a single having a biocompatible outer surface, an inner compartment, and a sealable port in communication with the inner compartment for expanding the casing in vivo;
  
  wherein, the casing hasa dimension ranging from a minimum of about 40 mm to a maximum of about 70 mm during operation of the device in a subject to avoid passage of any portion of the device through the lower esophageal sphincter or pyloric sphincter of the subject, limiting the intragastric device to a minimum volume of π
  
  (40 mm)³/6 or about 33 ml and a maximum volume of π
  
  (70 mm)³/6 or about 180 ml; and
  
  ,an aspect ratio ranging from about 1;
  
  1 to about 2;
  
  1 during operation of the device;
  
  a high specific gravity material, wherein the high specific gravity material has a specific gravity that is greater than 1.2 and contributes to a specific gravity of the device during use that ranges from about 1.2 to about 2.1, wherein the specific gravity functions to direct the device to the antrum of the stomach of the subject to induce gastric discomfort during use of the device;
  
  and,a hydrogel material;
  
  wherein,the intragastric device is at least substantially leakproof, functioning to provide a volume sufficient to avoid passage of any portion of the device through the lower esophageal sphincter or pyloric sphincter of the subject for a period of at least 9 months; and
  
  ,the specific gravity of the device allows the device to move freely about the distal stomach and apply pressure to the antrum without otherwise affecting normal gastric function of the subject.
- View Dependent Claims (38, 39, 40, 41, 42, 43, 44, 45, 46, 47, 48, 49, 50, 51)
- - 38. The device of claim 37, wherein the device has an in vivo specific gravity ranging from about 1.3 to about 1.6.
  - 39. The device of claim 37, wherein the device has an in vivo specific gravity ranging from about 1.2 to about 1.3.
  - 40. The device of claim 37, wherein the inner compartment contains the high specific gravity material.
  - 41. The device of claim 37, wherein the casing comprises the high specific gravity material.
  - 42. The device of claim 37, wherein the high specific gravity material is contained by the inner compartment and integrated with the casing.
  - 43. The device of claim 37, wherein the outer surface of the casing comprises the high specific gravity material.
  - 44. The device of claim 37, wherein at least a portion of the outer surface is composed of a material comprising a gastric-acid resistant, low friction material.
  - 45. The device of claim 37, wherein the device further comprises a surface that is compliant or substantially compliant with a surface of the antrum.
  - 46. The device of claim 37, wherein a portion of the outer surface is compliant or substantially compliant with a surface of the antrum having a durometer of at least about Shore 40A.
  - 47. The device of claim 37, wherein the casing comprises an ultrasonically visible marker for ultrasonically monitoring the device in vivo.
  - 48. A method of administering the device of claim 37, comprising:
    - placing the device in a collapsed state in the stomach of the subject; and
      
      ,expanding the device after the placing;
      
      wherein,the high specific gravity functions to direct the device to the antrum of the stomach.
  - 49. A method of treating obesity in a subject using the device of claim 37, wherein the method comprises:
    - placing the device in a collapsed state in the stomach of the subject;
      
      expanding the device; and
      
      ,treating the subject for an effective amount of time.
  - 50. The method of claim 49, wherein, the treating includes a deployment period of at least 9 months.
  - 51. A kit comprising the device of claim 37, a filling material having a specific gravity of greater than 1.2, and an insertion catheter designed for administration of the device in the subject.

52. An untethered, high specific gravity, antrum-based, intragastric device, comprising:
- a single expandable casing having a biocompatible outer surface and, upon expansion, a predetermined shape for contacting the antrum of the stomach of a subject;
  
  wherein,the expanded casing hasa minimum, cross-sectional dimension of about 40 mm during operation of the device in the subject to avoid passage of any portion of the device through the lower esophageal sphincter or pyloric sphincter of the subject after expansion;
  
  a maximum, cross-sectional dimension of the predetermined shape of about 70 mm for a positioning of the predetermined shape in the pyloric antrum of the subject;
  
  the minimum and maximum cross-sectional dimensions limiting the intragastric device to a minimum volume of π
  
  (40 mm)³/6 or about 33 ml and a maximum volume of π
  
  (70 mm)³/6 or about 180 ml;
  
  and,a filling material comprising a biocompatible fluid component and a hydrogel component, wherein the filling material has a specific gravity greater than 1.2 and contributes to an in vivo specific gravity of the device that ranges from about 1.2 to about 2.1, the specific gravity functioning to direct the device to the pyloric antrum of the subject to induce gastric discomfort during use of the device;
  
  wherein, the specific gravity of the device allows the device to move freely about the distal stomach and apply pressure to the antrum without otherwise affecting normal gastric function of the subject.
- View Dependent Claims (53, 54, 55, 56, 57, 58, 59, 60, 61)
- - 53. The device of claim 52, wherein the device has an in vivo specific gravity ranging from about 1.3 to about 1.6.
  - 54. The device of claim 52, wherein the device has an in vivo specific gravity ranging from about 1.2 to about 1.3.
  - 55. The device of claim 52, wherein the biocompatible fluid is selected from the group consisting of a salt solution, a sugar solution, honey, a sugar alcohol solution, glycerin, or a combination thereof.
  - 56. The device of claim 52, wherein the biocompatible fluid comprises a sugar alcohol solution.
  - 57. The device of claim 52, wherein the casing comprises an ultrasonically visible marker for ultrasonically monitoring the device in vivo.
  - 58. A method of administering the device of claim 52, comprising:
    - placing the device in a collapsed state in the stomach of the subject; and
      
      ,expanding the device after the placing;
      
      wherein,the high specific gravity functions to direct the device to the antrum of the stomach.
  - 59. A method of treating obesity in a subject using the device of claim 52, wherein the method comprises:
    - placing the device in a collapsed state in the stomach of the subject;
      
      expanding the device; and
      
      ,treating the subject for an effective amount of time.
  - 60. The method of claim 59, wherein, the treating includes a deployment period of at least 9 months.
  - 61. A kit comprising the device of claim 52, a filling material having a specific gravity of greater than 1.2, and an insertion catheter designed for administration of the device in the subject.

62. An intragastric device, comprising:
- a single flexible and expandable bladder having a predetermined shape upon expansion for contacting the antrum of the stomach of a subject;
  
  wherein,the device is designed to avoid passage of any part of the device beyond the pylorus and lower esophageal sphincter while the bladder is expanded during use in vivo;
  
  the bladder has a high specific gravity material when expanded;
  
  the high specific gravity material contributes to an in vivo specific gravity of the device that ranges from about 1.2 to about 2.1 and functions to direct the device to the pyloric antrum of the subject to induce gastric discomfort during use of the device;
  
  and,a filling material comprising a biocompatible fluid component and a hydrogel component, wherein the filling material has a specific gravity greater than 1.2;
  
  wherein,the intragastric device is limited to a minimum volume of π
  
  (40 mm)³/6 or about 33 ml and a maximum volume of π
  
  (70 mm)³/6 or about 180 ml;
  
  the intragastric device is at least substantially leakproof, functioning to provide a volume sufficient to avoid passage of any portion of the device through the lower esophageal sphincter or pyloric sphincter of the subject for a period of at least 9 months; and
  
  ,the specific gravity of the device allows the device to move freely about the distal stomach and apply pressure to the antrum without otherwise affecting normal gastric function of the subject.
- View Dependent Claims (63, 64, 65, 66, 67, 68, 69, 70, 71)
- - 63. The device of claim 62, wherein the device has an in vivo specific gravity ranging from about 1.3 to about 1.6.
  - 64. The device of claim 62, wherein the device has an in vivo specific gravity ranging from about 1.2 to about 1.3.
  - 65. The device of claim 62, wherein the biocompatible fluid is selected from the group consisting of a salt solution, a sugar solution, honey, a sugar alcohol solution, glycerin, or a combination thereof.
  - 66. The device of claim 62, wherein the biocompatible fluid comprises a sugar alcohol solution.
  - 67. The device of claim 62, wherein the casing comprises an ultrasonically visible marker for ultrasonically monitoring the device in vivo.
  - 68. A method of administering the device of claim 62, comprising:
    - placing the device in a collapsed state in the stomach of the subject; and
      
      ,expanding the device after the placing;
      
      wherein,the high specific gravity functions to direct the device to the antrum of the stomach.
  - 69. A method of treating obesity in a subject using the device of claim 62, wherein the method comprises:
    - placing the device in a collapsed state in the stomach of the subject;
      
      expanding the device; and
      
      ,treating the subject for an effective amount of time.
  - 70. The method of claim 69, wherein, the treating includes a deployment period of at least 9 months.
  - 71. A kit comprising the device of claim 62, a filling material having a specific gravity of greater than 1.2, and an insertion catheter designed for administration of the device in the subject.

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Current Assignee
John Hancock
Original Assignee
John Hancock
Inventors
Hancock, John
Primary Examiner(s)
DOWE, KATHERINE MARIE

Application Number

US12/645,466
Publication Number

US 20100168782A1
Time in Patent Office

1,645 Days
Field of Search

606/191, 606/192, 606/195, 606/198, 606/108, 604 9601-10314, 604/270, 604/509, 623/23.64, 623/23.65, 623/23.67, 600/37
US Class Current

606/192
CPC Class Codes

A61F 5/003 inflatable

A61F 5/0036 Intragastrical devices

High specific gravity intragastric device

First Claim

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Abstract

125 Citations

71 Claims

Specification

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High specific gravity intragastric device

First Claim

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Accused Products

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Abstract

125 Citations

71 Claims

Specification

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Use Cases

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