US2011137227A1PendingUtilityA1

Methods and devices for delivering or delaying lipids within a duodenum

53
Individually held — no corporate assignee on recordPriority: Jul 16, 2007Filed: Jul 2, 2009Published: Jun 9, 2011
Est. expiryJul 16, 2027(~1 yrs left)· nominal 20-yr term from priority
Inventors:James T. MckinleyZhenyong KeckFiona M. Sander
A61M 27/002A61F 5/0079
53
PatentIndex Score
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Claims

Abstract

Devices are described that are adapted and configured for use within the duodenum of a mammal. One aspect of the device includes a spine having a proximal end and a distal end; an atraumatic feature positioned on at least one of the proximal end and the distal end of the spine; and a flow reduction element positioned along the spine and having a variable porosity along its length. In another aspect, there is a flow reduction device adapted and configured for use within the duodenum of a mammal having a spine having a length, a proximal end and a distal end; a first atraumatic feature positioned adjacent to the spine proximal end; a second atraumatic feature positioned adjacent to the spine distal end wherein the length of the spine is selected so that when the first atraumatic feature is in the stomach the second atraumatic feature is in the fourth portion of the duodenum; and a flow reduction element having a proximal end, a distal end, an interior portion, an exterior portion and a variable porosity between the proximal end and the distal end. Additionally or alternatively, some or all of the components of the device may be formed from or coated with a lipid-philic material. There is also provided a method for adjusting the passage of ingesta through the duodenum of a mammal. The method includes placing the distal end of a flow reduction device in the duodenum of a mammal; placing the proximal end of the flow reduction device in a stomach of the mammal; expanding within the duodenum of the mammal a variable porosity flow reduction element supported by the flow reduction device; and directing at least a portion of the flow of ingesta through the duodenum through the proximal end of the variable porosity flow reduction element and into an interior portion of the variable porosity flow reduction element.

Claims

exact text as granted — not AI-modified
1 . A device adapted and configured for use within the duodenum of a mammal, comprising:
 a spine having a proximal end and a distal end;   an atraumatic feature positioned on at least one of the proximal end and the distal end of the spine; and   a flow reduction element positioned along the spine and having a variable porosity along its length.   
     
     
         2 . The device of  claim 1  wherein the variable porosity of the flow reduction element is selected so that a portion of a flow over the proximal end of the flow reduction element flows into an interior portion of the flow reduction element. 
     
     
         3 . The device of  claim 1  wherein the variable porosity of the flow reduction element is selected so that flow within an interior of the flow reduction element is at least partially inhibited from flowing through the distal portion of the variable porosity structure. 
     
     
         4 . The device of  claim 1  wherein a proximal portion of the flow reduction element comprises a material, a mesh or a braid having a porosity or altered to provide a porosity selected to permit a flow into an interior portion of the flow reduction element. 
     
     
         5 . The device of  claim 1  wherein a distal portion of the flow reduction element comprises a material, a mesh or a braid having a porosity or altered to provide a porosity selected to at least partially inhibit a flow from within an interior portion of the flow reduction element. 
     
     
         6 . The device of  claim 1  wherein the length of the spine is selected so when the atraumatic feature is positioned in a stomach the flow reduction element is positioned on the spine and distal to a pylorus. 
     
     
         7 . The device of  claim 1  wherein the length of the spine is selected so when the atraumatic feature is positioned in a stomach the distal end of the spine is in the fourth portion of the duodenum and the flow reduction element is positioned within a portion of the duodenum. 
     
     
         8 . The device of  claim 1  further comprising:
 a flow reduction element having a non-variable porosity along its length. 
 
     
     
         9 . The device of  claim 8  wherein the flow reduction element is at least partially formed from a lipid-philic material. 
     
     
         10 . The device of  claim 8  wherein at least a portion of the interior or the exterior of the flow reduction element is at least partially coated with a lipid-philic material. 
     
     
         11 . The device of  claim 1  further comprising:
 a feature on the spine positioned to restrict movement of the flow reduction element relative to the spine. 
 
     
     
         12 . The device of  claim 1  wherein the flow reduction element is at least partially formed from a lipid-philic material. 
     
     
         13 . The device of  claim 1  wherein at least a portion of the interior or the exterior of the flow reduction element is at least partially coated with a lipid-philic material. 
     
     
         14 . The device of  claim 1  further comprising:
 a lipid-philic structure within the flow reduction element. 
 
     
     
         15 . The device of  claim 14  wherein the lipid-philic structure within the flow reduction element is attached to the spine. 
     
     
         16 . The device of  claim 14  wherein the lipid-philic structure within the flow reduction element is attached to the flow reduction element. 
     
     
         17 . A device adapted and configured for use within the duodenum of a mammal, comprising:
 a spine having a length, a proximal end and a distal end;   a first atraumatic feature positioned adjacent to the spine proximal end;   a second atraumatic feature positioned adjacent to the spine distal end wherein the length of the spine is selected so that when the first atraumatic feature is in the stomach the second atraumatic feature is in the fourth portion of the duodenum; and   a flow reduction element positioned along the spine and having a proximal end, a distal end, an interior portion, an exterior portion and a variable porosity between the proximal end and the distal end.   
     
     
         18 . The device of  claim 10  wherein the porosity of the proximal end is selected to the allow flow to pass from the exterior portion to the interior portion. 
     
     
         19 . The flow reduction device of  claim 10  wherein the porosity of the distal end is selected to impede flow from the interior portion to the exterior portion. 
     
     
         20 . The flow reduction device of  claim 10  wherein the proximal portion is more porous than the distal portion. 
     
     
         21 . The device of  claim 10  wherein the proximal end has a porous structure configured to permit flow into the interior portion and the distal end has a solid portion to retain material within the interior portion. 
     
     
         22 . The device of  claim 10  further comprising:
 another flow reduction element between the proximal and distal ends of the spine. 
 
     
     
         23 . The device of  claim 15  wherein the another flow reduction element has variable porosity between the proximal and distal ends of the flow reduction element. 
     
     
         24 . The device of  claim 10  wherein the length of the spine is selected so that when the first atraumatic feature is positioned in a stomach the second atraumatic feature is positioned within the duodenum and adjacent to the first atraumatic feature. 
     
     
         25 . The device of  claim 10  wherein the length of the spine is selected so that when the first atraumatic feature is positioned in a stomach the second atraumatic feature is positioned within the duodenum and in proximity to the ligament of Treitz. 
     
     
         26 . The device of  claim 10  wherein the flow reduction element is at least partially formed from a lipid-philic material. 
     
     
         27 . The device of  claim 10  wherein at least a portion of the interior or the exterior of the flow reduction element is at least partially coated with a lipid-philic material. 
     
     
         28 . The device of  claim 10  further comprising:
 a lipid-philic structure within the flow reduction element. 
 
     
     
         29 . The device of  claim 28  wherein the lipid-philic structure within the flow reduction element is attached to the spine. 
     
     
         30 . The device of  claim 28  wherein the lipid-philic structure within the flow reduction element is attached to the flow reduction element. 
     
     
         31 . A method for adjusting the passage of ingesta through the duodenum of a mammal, comprising:
 placing the distal end of a device in the duodenum of a mammal;   placing the proximal end of the device in a stomach of the mammal;   expanding within the duodenum of the mammal a variable porosity flow reduction element supported by the device; and   directing at least a portion of the flow of ingesta through the duodenum through the proximal end of the variable porosity flow reduction element and into an interior portion of the variable porosity flow reduction element.   
     
     
         32 . The method for adjusting the passage of ingesta according to  claim 19  further comprising:
 retaining a portion of the ingesta within the interior portion of the variable porosity flow reduction element until the ingesta is pushed out of the interior portion by peristaltic action of the duodenum. 
 
     
     
         33 . The method for adjusting the passage of ingesta according to  claim 20  wherein the ingesta is pushed out of the interior portion by passing through a distal portion of the variable porosity flow reduction element. 
     
     
         34 . The method for adjusting the passage of ingesta according to  claim 20  wherein the ingesta is pushed out of the interior portion by passing through the proximal portion and thereafter passing around the variable porosity flow reduction element. 
     
     
         35 . A method for adjusting the passage of ingesta through the duodenum of a mammal, comprising:
 placing the distal end of a device in the duodenum of a mammal;   placing the proximal end of the device in a stomach of the mammal; expanding within the duodenum of the mammal a flow reduction element supported by the device wherein at least one component of the device is at least partially formed from or coated with a lipid-philic material; and   joining a lipid comprising compound to the at least one component of the device that is at least partially formed from or coated with a lipid-philic material.   
     
     
         36 . The method of  claim 35  further comprising: 
       Releasing at least a portion of the lipid comprising compound from the at least one component of the device. 
     
     
         37 . The method of  claim 35  wherein the at least one component is a flow reduction element and the lipid comprising compound is attached to the exterior of the flow reduction element. 
     
     
         38 . The method of  claim 35  wherein the at least one component is a flow reduction element and the lipid comprising compound is attached to the interior of the flow reduction element. 
     
     
         39 . The method of  claim 35  wherein the at least one component is a spine of the device and the lipid comprising compound is attached to the spine adjacent to a flow reduction element. 
     
     
         40 . The method of  claim 35  further comprising: 
       After the joining step, contacting an interior wall of the duodenum with a portion of the at least one component. 
     
     
         41 . A device adapted and configured for use within the duodenum of a mammal, comprising:
 a spine having a length, a proximal end and a distal end;   a first atraumatic feature positioned adjacent to the spine proximal end;   a second atraumatic feature positioned adjacent to the spine distal end wherein the length of the spine is selected so that when the first atraumatic feature is in the stomach the second atraumatic feature is in the fourth portion of the duodenum; and   a flow reduction element positioned along the spine and having a proximal end, a distal end, an interior portion, an exterior portion, wherein at least a portion of the device is at least partially made from or coated with a lipid-philic material.   
     
     
         42 . The device of  claim 41  wherein the at least a portion of the device that is at least partially made from or coated with a lipid-philic material is the flow reduction element. 
     
     
         43 . The device of  claim 41  wherein the at least a portion of the device that is at least partially made from or coated with a lipid-philic material is the spine.

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