Gastric space filler device, delivery system, and related methods

• US 9,283,102 B2
• Filed: 03/29/2011
• Issued: 03/15/2016
• Est. Priority Date: 06/25/2007
• Status: Active Grant

• Current Assignee: Boston Scientific Scimed, Inc. (Boston Scientific Corporation)
• Original Assignee: Reshape Medical, Inc. (ReShape LifeSciences, Inc.)
• Inventors: Sosnowski, Stephen Alexander, Holschlag, Tyler John, Kincade, Daniel Eugene
• Primary Examiner(s): Rodjom, Katherine
• Application Number:
  US13/074,956
• Publication Number:
  US 20110178544A1
• Time in Patent Office: 1,813 Days
• Field of Search: 606/191, 606/192, 606/195, 600/37
• US Class Current: 1/1
• CPC Class Codes: A61F 5/0033 with more than one chamber
• CPC Class Codes: A61F 5/0036 Intragastrical devices
• CPC Class Codes: A61F 5/0089 Instruments for placement or removal
• CPC Class Codes: A61M 2025/0177 having external means for receiving guide wires, wires or stiffening members, e.g. loops, clamps or lateral tubes
• CPC Class Codes: A61M 25/09 Guide wires

Abstract

According to features of the present disclosure, a gastric space filler device and methods effective for reducing stomach volume are disclosed. A gastric space filler comprising at least one inflatable space filler and a sleeve to prevent leakage out of the gastric space filler device is disclosed. The gastric space filler device may be inflated with an insufflation fluid and with mineral oil, which further has the effect of reducing leakage. Delivery systems and methods for inserting a gastric space filler device into a patient are also disclosed. Sheaths and methods for covering a gastric space filler device during delivery into a patient are also disclosed.

Claims

1. A method of delivering a gastric space filler device, the method comprising:

attaching a delivery system to a gastric space filler device by releasably coupling a docking clip of the delivery system to a docking notch at a proximal end of an infusing member of the gastric space filler device;

delivering a guidewire through an esophagus to a stomach;

after the delivery system is attached to the gastric space filler, guiding the gastric space filler device and the delivery system together over the guidewire to the stomach;

inflating a space filler of the gastric space filler device with a fluid provided from the delivery system through an infusing lumen in the infusing member of the gastric space filler device;

detaching the delivery system from the gastric space filler device by removing the docking clip from the docking notch; and

removing the delivery system from the stomach without removing the gastric space filler device from the stomach.

2. The method of claim 1 wherein the delivery system is attached to the gastric space filler device before the gastric space filler device and the delivery system are guided along the path defined by the guidewire.

3. The method of claim 1 wherein attaching the delivery system to the gastric space filler device further comprises inserting a barb of the delivery system into a gate at the proximal end of the infusing member of the gastric space filler device.

4. The method of claim 3 wherein attaching the delivery system to the gastric space filler device comprises attaching the delivery system such that the barb provides fluid communication between a delivery lumen of the delivery system and the infusing lumen of the gastric space filler device when the barb is inserted into the gate.

5. The method of claim 3 wherein detaching the delivery system from the gastric space filler device further comprises removing the barb from the proximal end of the infusing member after at least partially inflating the space filler.

6. The method of claim 5 wherein removing the barb from the proximal end of the infusing member causes the gate to close.

7. The method of claim 1 wherein the infusing member of the gastric space filler device comprises a filler guide wire channel and the delivery system comprises a delivery guide wire channel, and wherein the method further comprises threading the guidewire through at least one of the filler guide wire channel and the delivery guide wire channel before guiding the gastric space filler device and the delivery system along the path defined by the guidewire.

8. The method of claim 7 wherein the filler guide wire channel extends from a proximal end of the infusing member to a distal end of the infusing member.

9. The method of claim 1, further comprising at least partially covering the gastric space filler device with a sheath before guiding the gastric space filler device along the guidewire.

10. The method of claim 1 wherein the infusing member extends completely through the space filler and includes a guidewire channel separate from the infusing lumen, and wherein the guidewire channel extends completely through the infusing member and is configured to receive the guidewire.

11. A gastric space filler system, comprising:

a gastric space filler device comprising

a flexible, elongate infusing member having a proximal end, a distal end, a filler guide wire channel extending completely through the infusing member from the proximal end to the distal end, and an infusing lumen separate from the filler guide wire channel;

a plurality of inflatable gastric space fillers secured to the infusing member, wherein the infusing member extends completely through the gastric space fillers; and

a docking notch at the proximal end of the infusing member; and

a delivery system having a docking clip configured to be attached over the docking notch to releasably attach the delivery system to the gastric space filler device, wherein the delivery system includes a delivery guide wire channel in communication with the filler guide wire channel and a fluid delivery lumen in communication with the infusing lumen when the delivery system is attached to the gastric space filler device.

12. The gastric space filler system of claim 11 wherein:

the plurality of inflatable gastric space fillers comprise a proximal inflatable space filler and a distal inflatable space filler;

the infusing lumen of the gastric space filler device comprises a proximal lumen in fluid communication with the proximal inflatable gastric space filler and a distal lumen in fluid communication with the distal inflatable gastric space filler; and

the delivery system further comprises

a proximal barb configured to be inserted into the proximal lumen of the infusing member and provide fluid communication between the delivery system and the proximal inflatable space filler; and

a distal barb configured to be inserted into the distal lumen of the infusing member and provide fluid communication between the delivery system and the distal inflatable space filler.

13. The gastric space filler system of claim 12 wherein the proximal inflatable space filler and the proximal infusing lumen are not in fluid communication with the distal inflatable space filler and the distal infusing lumen.

14. The gastric space filler system of claim 11, further comprising a guidewire threaded through the filler guide wire channel and the delivery guide wire channel.

15. The gastric space filler system of claim 11 wherein at least one of the gastric space fillers has an outer diameter of at least about 40 mm when inflated with a fluid.

16. The gastric space filler system of claim 11 wherein the gastric space fillers are configured to at least partially fill a portion of a stomach of a human patient to create a feeling of satiety.