Variable size intragastric implant devices

• US 9,463,107 B2
• Filed: 10/12/2011
• Issued: 10/11/2016
• Est. Priority Date: 10/18/2010
• Status: Active Grant

• Current Assignee: Boston Scientific Scimed (Boston Scientific Corporation)
• Original Assignee: Apollo Endosurgery, Inc. (Boston Scientific Corporation)
• Inventors: Babkes, Mitchell H., Snow, Sean
• Primary Examiner(s): LOUIS, RICHARD G
• Application Number:
  US13/272,106
• Publication Number:
  US 20120095492A1
• Time in Patent Office: 1,826 Days
• Field of Search: 606/191, 606/198
• US Class Current: 1/1
• CPC Class Codes: A61F 5/003 inflatable
• CPC Class Codes: A61F 5/004 remotely adjustable

Abstract

Transoral obesity treatment devices and related methods for operation thereof are described which occupy space within a stomach and/or stimulate the stomach wall. The transoral obesity treatment devices and related methods are intended to assist a patient in maintaining a healthy body weight. Features of the devices include insertion transorally and without invasive surgery, without associated patient risks of invasive surgery, and without substantial patient discomfort. The life span of these devices may be material-dependent upon long-term survivability within an acidic stomach, but is intended to last one year or longer. The devices have the capacity to vary in size and are desirably self-actuating in that they change shape and/or volume using internal motors or actuators. The changing character of the devices helps prevent the person'"'"'s stomach from compensating for the implant, such as sometimes happens with static intragastric devices.

Claims

1. A system for an implantable device, the device being of a size that is too large to pass through an opening of a patient'"'"'s pylorus, the device constructed for placement completely within a patient'"'"'s stomach and constructed to be introduced into the stomach transorally without surgery to treat and prevent obesity by applying an outwardly directed pressure to the patient'"'"'s stomach from within the stomach, comprising:

a central elongated body having telescopically adjustable length and a longitudinal axis;

two collapsible atraumatic feet extending from opposite ends of the elongated body, each foot constructed to assume an elongated delivery configuration in which the foot is positioned at a first radially collapsed position where said feet are elongated along said longitudinal axis, and to move to a deployed configuration in which the foot is in a second radially expanded position where said feet form stomach-contacting surfaces that are substantially perpendicular to said longitudinal axis at opposite ends of the elongated body, the two collapsible atraumatic feet comprising an array of living hinges that may be unfolded to said elongated delivery configuration and folded outward to said deployed configuration, each foot configured to exert an outwardly directed pressure on an interior of the patient'"'"'s stomach from within the stomach when the foot is in the deployed configuration when the central elongated body and the atraumatic feet are completely contained within the interior of the stomach without the elongated body piercing any portion of the stomach, wherein the central elongated body does not pass through the atraumatic feet along the longitudinal axis; and

an actuator at least partially within the central elongated body configured to simultaneously adjust the length of the body and the distance between the atraumatic feet.

2. The system of claim 1, wherein the two collapsible atraumatic feet comprise balloon-like structures.

3. The system of claim 1, wherein the array of living hinges are in an X-shape.

10. The system of claim 1, wherein the atraumatic feet include uneven external surface stimulation features.

11. The system of claim 1, wherein the actuator is contained within the central elongated body.

12. The system of claim 11, wherein the actuator is configured such that when the actuator is actuated the length of the body and the distance between the atraumatic feet are simultaneously adjusted.

13. The system of claim 11, wherein the actuator is configured such that when the actuator is actuated the length of the body and the radially expanded position of at least one of the atraumatic feet are simultaneously adjusted.

16. The system of claim 1, wherein the actuator is configured to adjust the length of the body and the distance between the atraumatic feet at random or pre-set distances and at random or pre-set time intervals.

17. The system of claim 1, wherein at least one of the atraumatic feet is comprised of an array of discrete collapsible fingers.

18. The system of claim 17, wherein each finger is formed as a loop that extends in a plane and wherein each finger is configured to bend about thinned regions of each loop such that the finger is collapsible within its respective plane.

19. The system of claim 18, wherein the plane is parallel to the longitudinal axis.

20. The system of claim 18, wherein each loop has a first end and a second end opposite the first end, wherein the first ends of all of the loops of one foot are joined to an end of the elongated body and the second ends of all of the loops, opposite the first ends, are joined together at a location longitudinally spaced from the end of the elongated body.

21. The system of claim 17, wherein in the deployed configuration the fingers extend radially with respect to the longitudinal axis.

4. A system for an implantable device, the device being of a size that is too large to pass through an opening of a patient'"'"'s pylorus, the device constructed for deployment completely within a patient'"'"'s stomach and constructed to be introduced into the stomach transorally without surgery to treat and prevent obesity by applying an outwardly directed pressure to the patient'"'"'s stomach from within the stomach, comprising:

a central elongated body having an adjustable length;

two collapsible atraumatic feet on opposite ends of the elongated body, each foot constructed to exert an outwardly directed pressure on an interior of the patient'"'"'s stomach from within the stomach when the foot is in a deployed configuration when the central elongated body and the two atraumatic feet are completely contained within the interior of the stomach without the elongated body piercing any portion of the stomach; and

an actuator comprising an electronic motor within the central elongated body, the electric motor actuated to simultaneously adjust the length of the body and the distance between the atraumatic feet.

5. The system of claim 4, wherein the actuator further comprises a control circuit board having a battery and a memory.

6. The system of claim 5, wherein the actuator further comprises a control circuit board having a transceiver, and the system further includes a remote control for instructing the motor from outside the patient'"'"'s body.

7. The system of claim 4, wherein the actuator further comprises a telescoping screw driven by the motor.

8. A system for an implantable device, the device being of a size that is too large to pass through an opening of a patient'"'"'s pylorus, the device constructed for placement completely within a patient'"'"'s stomach and constructed to be introduced into the stomach transorally without surgery to treat and prevent obesity by applying an outwardly directed pressure to the patient'"'"'s stomach from within the stomach, comprising:

a central elongated body having telescopically adjustable length and a longitudinal axis;

two collapsible atraumatic feet extending from opposite ends of the elongated body, each foot constructed to assume an elongated delivery configuration in which the foot is positioned at a first radially collapsed position where said feet are elongated along said longitudinal axis, and to move to a deployed configuration in which the foot is in a second radially expanded position where said feet form stomach-contacting surfaces that are substantially perpendicular to said longitudinal axis at opposite ends of the elongated body, each foot configured to exert an outwardly directed pressure on an interior of the patient'"'"'s stomach from within the stomach when the foot is in the deployed configuration when the central elongated body and the atraumatic feet are completely contained within the interior of the stomach without the elongated body piercing any portion of the stomach, wherein the central elongated body does not pass through the atraumatic feet along the longitudinal axis; and

an actuator at least partially within the central elongated body configured to simultaneously adjust the length of the body and the distance between the atraumatic feet,

wherein the actuator comprises an acid-activated lengthening polymer element that is acid-activated to lengthen in a highly acidic environment, and the central elongated body defines through holes for exposing the polymer element to the stomach environment.

9. The system of claim 8, wherein the central elongated body comprises a series of telescoping tubular members having apertures along their lengths.

14. A system for an implantable device, the device being of a size that is too large to pass through an opening of a patient'"'"'s pylorus, the device constructed for placement completely within a patient'"'"'s stomach and constructed to be introduced into the stomach transorally without surgery to treat and prevent obesity by applying an outwardly directed pressure to the patient'"'"'s stomach from within the stomach, comprising:

a central elongated body having telescopically adjustable length and a longitudinal axis;

two collapsible atraumatic feet on opposite ends of the elongated body, each foot constructed to assume an elongated delivery configuration in which the foot is positioned at a first radially collapsed position where said feet are elongated along said longitudinal axis, and to move to a deployed configuration in which the foot is in a second radially expanded position where said feet form stomach-contacting surfaces that are substantially perpendicular to said longitudinal axis at opposite ends of the elongated body, each foot configured to exert an outwardly directed pressure on an interior of the patient'"'"'s stomach from within the stomach when the foot is in the deployed configuration when the central elongated body and the atraumatic feet are completely contained within the interior of the stomach without the elongated body piercing any portion of the stomach; and

an actuator within the central elongated body configured to simultaneously adjust the length of the body and the distance between the atraumatic feet,

wherein the actuator includes a piston that biases the atraumatic feet away from each other.

15. A system for an implantable device, the device being of a size that is too large to pass through an opening of a patient'"'"'s pylorus, the device constructed for placement completely within a patient'"'"'s stomach and constructed to be introduced into the stomach transorally without surgery to treat and prevent obesity by applying an outwardly directed pressure to the patient'"'"'s stomach from within the stomach, comprising:

a central elongated body having telescopically adjustable length and a longitudinal axis;

two collapsible atraumatic feet extending from opposite ends of the elongated body, each foot constructed to assume an elongated delivery configuration in which the foot is positioned at a first radially collapsed position where said feet are elongated along said longitudinal axis, and to move to a deployed configuration in which the foot is in a second radially expanded position where said feet form stomach-contacting surfaces that are substantially perpendicular to said longitudinal axis at opposite ends of the elongated body, each foot configured to exert an outwardly directed pressure on an interior of the patient'"'"'s stomach from within the stomach when the foot is in the deployed configuration when the central elongated body and the atraumatic feet are completely contained within the interior of the stomach without the elongated body piercing any portion of the stomach, wherein the central elongated body does not pass through the atraumatic feet along the longitudinal axis; and

an actuator at least partially within the central elongated body configured to simultaneously adjust the length of the body and the distance between the atraumatic feet, the actuator including a telescoping screw to operably shorten or lengthen the central elongated body.