PYLORIC OBSTRUCTION DEVICE WITH SPACE-OCCUPYING DEVICE

Abstract

An assembly includes an obstruction device including a proximal obstruction balloon and a distal obstruction balloon mounted on a shaft, the balloons being inflatable via one or more inflation lumens, and a space-occupying device mounted on a positioning member that extends from a portion of the obstruction device, the space-occupying device being proximal to the proximal obstruction balloon and inflatable via a space-occupying-device inflation lumen.

Claims

1. An assembly comprising: an obstruction device comprising a proximal obstruction balloon and a distal obstruction balloon mounted on a shaft, said balloons being inflatable via one or more inflation lumens; and a space-occupying device mounted on a positioning member that extends from a portion of said obstruction device, said space-occupying device being proximal to said proximal obstruction balloon and inflatable via a space-occupying-device inflation lumen.

2. The assembly according to claim 1, wherein said positioning member is straight.

3. The assembly according to claim 1, wherein said positioning member is not straight.

4. The assembly according to claim 1, wherein said positioning member is inflatable.

5. The assembly according to claim 1, wherein said positioning member is constructed of a shape memory material.

6. The assembly according to claim 1, wherein at least one of said proximal obstruction balloon, said distal obstruction balloon and said space-occupying device comprises internal or external anchoring arms.

7. The assembly according to claim 1, wherein said positioning member is sized and shaped to position said space-occupying device in a fundus of a patient when said proximal obstruction balloon is placed on a proximal side of a pylorus of the patient and said distal obstruction balloon is placed on a distal side of the pylorus.

8. A method comprising using said assembly of claim 1 to place said proximal obstruction balloon on a proximal side of a pylorus of a patient and said distal obstruction balloon on a distal side of the pylorus, and using said positioning member to position said space-occupying device in a fundus of the patient.

Description

BRIEF DESCRIPTION OF THE DRAWINGS

[0016] The present invention will be understood and appreciated more fully from the following detailed description taken in conjunction with the drawings in which:

[0017] FIGS. 1A and 1B are simplified illustrations of an obstruction assembly, constructed and operative in accordance with an embodiment of the present invention, respectively before and after inflation of a space-occupying device connected to proximal and distal balloons; and

[0018] FIGS. 2A-2C are simplified illustrations of a method of using the obstruction assembly, in accordance with an embodiment of the present invention, wherein FIG. 2A illustrates introduction of the assembly through the esophagus to the stomach, FIG. 2B illustrates inflation of the proximal and distal balloons on opposite sides of the pylorus, and FIG. 2C illustrates placement and inflation of the space-occupying device in the fundus.

DETAILED DESCRIPTION OF EMBODIMENTS

[0019] Reference is now made to FIG. 1, which illustrates an obstruction assembly 10, constructed and operative in accordance with an embodiment of the present invention.

[0020] Obstruction assembly 10 includes a proximal obstruction balloon 12 and a distal obstruction balloon 14 mounted on a shaft 16. A portion of shaft 16, referred to as neck 18 or neck portion 18, provides a gap between proximal balloon 12 and distal balloon 14. Neck 18 can have different lengths and thicknesses depending on the application; for example, the dimensions of neck 18 are correlated to the usual width of the pylorus muscle.

[0021] The proximal obstruction balloon 12 is arranged to fit in the stomach, whereas the distal obstruction balloon 14 is arranged to fit in the duodenum. When inflated, balloons 12 and 14 expand towards the pylorus from opposite sides on the pylorus, thus fixing the plug 10 in place. The balloons may be inflated via one or more inflation lumens 20 formed in shaft 16, which are in fluid communication with a fluid source (not shown), such as air, water or saline, for example. The inflation lumens 20 may also be in fluid communication with a suction source (not shown) for deflation of the balloons; alternatively, one or more lumens dedicated for deflation may be provided.

[0022] In accordance with an embodiment of the present invention, proximal obstruction balloon 12 and/or distal obstruction balloon 14 may include a plurality of internal or external anchoring arms 22. In one embodiment, anchoring arms 22 are constructed from folds in balloon 14. In another embodiment, anchoring arms 22 may be arcuate loops of a flexible yet strong material suitable for anchoring against the intestinal walls, such as but not limited to, NITINOL or stainless steel alloy. One purpose of arms 22 is to help anchor the device against the pylorus in the duodenum and/or stomach. Another purpose is to create a non-uniform surface for pushing against tissue. The non-uniform surface may help prevent creating constant pressure, which would have the disadvantageous risk of causing a sore, like a pressure sore, on the tissue.

[0023] In accordance with an embodiment of the present invention, a space-occupying device 24 is mounted on a positioning member 26 that extends from a portion of the obstruction device, that is, a portion of proximal obstruction balloon 12, distal obstruction balloon 14 or shaft 16. The space-occupying device 24 is proximal to the proximal obstruction balloon 12 and may be a balloon which is inflatable via a space-occupying-device inflation lumen 28 formed in shaft 16 or in another shaft (not shown). The space-occupying device 24 may be deflated through the inflation lumen or another lumen. The balloons 12 and 14 and the space-occupying device 24 may be deflated simultaneously or one at a time.

[0024] The positioning member 26 may be a straight rod, tube or other slender elongate member. Alternatively, positioning member 26 may be not straight (e.g., curved, bent or made of pivoting links and the like). Positioning member 26 may be constructed so as to have a contracted orientation for insertion in the stomach and an expanded or deployed orientation for assuming its final position in the stomach. For example, positioning member 26 may be inflatable so that it expands to its final position in the stomach. As another example, positioning member 26 may be constructed of a shape memory material (such as but not limited to, NITINOL) so that it changes its shape from the contracted orientation to its final deployed orientation in the stomach. The positioning member 26 may be collinear with the shaft 16, or may be offset from the shaft 16.

[0025] Reference is now made to FIGS. 2A-2C, which illustrate a method of using the obstruction assembly, in accordance with an embodiment of the present invention.

[0026] FIG. 2A illustrates introduction of the assembly through the esophagus 29 to the stomach 32 with an endoscopic tool 30. FIG. 2B illustrates inflation of the proximal balloon 12 and the distal balloon 14 on opposite sides of the pylorus 33 (the distal balloon 14 is positioned in the duodenum 34). FIG. 2C illustrates placement and inflation of the space-occupying device 24 in the fundus 36.

[0027] Accordingly, the positioning member 26 is sized and shaped to position the space-occupying device 24 in its final deployed orientation in the stomach, such as the fundus of the patient, when the proximal obstruction balloon 12 is placed on the proximal side of the pylorus of the patient and the distal obstruction balloon 14 is placed on the distal side of the pylorus.