Expandable sheath for percutaneous upper gastrointestinal tract access

• US 20060259061A1
• Filed: 04/24/2006
• Published: 11/16/2006
• Est. Priority Date: 04/22/2005
• Status: Abandoned Application

• Current Assignee: Onset Medical Corp. (Terumo Corporation)
• Original Assignee: Onset Medical Corp. (Terumo Corporation)
• Inventors: Kick, George F., Nance, Edward J., Lenker, Jay
• Application Number:
  US11/409,723
• Publication Number:
  US 20060259061A1
• Time in Patent Office: Days
• US Class Current: 606/191
• CPC Class Codes: A61M 2025/0024 Expandable catheters or sheaths
• CPC Class Codes: A61M 2025/0034 characterized by elements which are assembled, connected or fused, e.g. splittable tubes, outer sheaths creating lumina or separate cores
• CPC Class Codes: A61M 2025/0036 with more than four lumina
• CPC Class Codes: A61M 2025/0039 characterized by lumina being arranged coaxially
• CPC Class Codes: A61M 2210/1053 Stomach
• CPC Class Codes: A61M 25/0045 multi-layered, e.g. coated coating materials A61L29/08
• CPC Class Codes: A61M 25/0075 Valve means
• CPC Class Codes: A61M 25/0108 using radio-opaque or ultrasound markers
• CPC Class Codes: A61M 25/0147 with movable mechanical means, e.g. pull wires
• CPC Class Codes: A61M 25/04 in the body, e.g. expansible A61M25/10, A61M16/0488 take precedence
• CPC Class Codes: A61M 25/1002 characterised by balloon shape A61M25/1006, A61M25/1009 take precedence
• CPC Class Codes: A61M 29/02 Dilators made of swellable material balloon catheters for angioplasty A61M25/104

Abstract

Disclosed is an expandable percutaneous sheath, for introduction into the body while in a first, low cross-sectional area configuration, and subsequent expansion of at least a part of the distal end of the sheath to a second, enlarged cross-sectional configuration. The sheath is configured for use in the upper gastrointestinal tract and has utility in the performance of procedures in the esophagus and stomach. The access route is through the anterior abdominal wall to the stomach. The distal end of the sheath is maintained in the first, low cross-sectional configuration during advancement through the abdominal wall and into the stomach. The distal end of the sheath is subsequently expanded using a radial dilatation device. In an exemplary application, the sheath is utilized to provide access for a diagnostic or therapeutic procedure such as diagnosis and repair of gastro esophageal reflux disease. The sheath further can be secured within the gastrointestinal system and be used to draw the stomach wall against the abdominal wall.

Claims

1. An expandable endogastric access sheath for providing minimally invasive access to the upper digestive tract, the sheath comprising:

an axially elongate sheath with a proximal end, a distal end, and a central lumen that extends therethrough, a distal region of the sheath being located generally at the distal end of the sheath and being configured to be is expandable in circumference in response to outward pressure applied therein,

a hub coupled to the proximal end of the sheath tube;

an obturator positioned in the central lumen, the obturator configured to occlude the central lumen of the sheath during insertion, the obturator including a hub, a guidewire lumen extending through the obturator, and an expandable portion configured to expand the distal region of the sheath from a collapsed configuration to an expanded configuration;

a radially expandable distal anchor positioned on the sheath; and

a radially expandable proximal anchor positioned on the sheath proximal to the distal anchor.

2. The endogastric access sheath of claim 1 wherein the sheath comprises an outer layer, an inner layer, and a reinforcing layer wherein the outer layer and the inner layer are fabricated from polymeric materials.

3. The endogastric access sheath of claim 2 where the sheath comprises a reinforcing layer embedded within layers fabricated from polymeric materials.

4. The endogastric access sheath of claim 2 wherein the reinforcing layer is a coil of metal.

5. The endogastric access sheath of claim 2 wherein the reinforcing layer is a braid.

6. The endovascular access sheath of claim 2 wherein the inner and outer layer are fabricated from different polymers.

7. The endogastric access sheath of claim 2 wherein the length of the sheath is between 10 and 150 cm.

8. The endogastric access sheath of claim 2 wherein the inner lumen of the sheath ranges between 6 and 30 French when the distal region is fully expanded.

9. A method of proving access to a stomach of a patient, the method comprising the steps of:

inserting a guidewire through the abdominal wall into the stomach;

inserting a sheath with at least a distal region in a collapsed configuration and with a pre-inserted dilator positioned within a lumen in the sheath into the patient over the guidewire;

advancing the sheath to a treatment or diagnostic site within the stomach or upper digestive tract;

expanding the distal region of the sheath with the dilator;

collapsing the dilator;

removing the dilator from the sheath,

inserting a instrument through the lumen of the sheath into the stomach;

performing therapy or diagnosis with the instrument; and

removing the sheath from the patient.

10. The method of claim 9, wherein the step of expanding the distal region of the sheath with the dilator comprises inflating a balloon carried by the dilator.

11. The method of claim 10, wherein the step of inflating the balloon carried by the dilator comprises coupling a liquid-filled inflation device to a balloon inflation port of the dilator and infusing liquid under pressure into the dilator.

12. The method of claim 11, wherein the step of collapsing the dilator comprises withdrawing a plunger on the liquid-filled inflation device to withdraw liquid from the dilator.

13. The method of claim 9, wherein performing therapy or diagnosis with the instrument comprises performance of a Nissen fundoplication.

14. The method of claim 9, wherein performing therapy or diagnosis with the instrument comprises delivering heat or cold energy to the patient.

15. The method of claim 9, wherein the step of expanding the distal region of the sheath with the dilator comprises creating a lumen that is substantially larger than a lumen of a proximal portion of the sheath.

16. The method of claim 9 wherein the step of expanding the distal region of the sheath with the dilator comprises creating a lumen substantially smaller than that of a proximal portion of the sheath.

17. The method of claim 9, wherein the step of expanding the distal region of the sheath with the dilator comprises creating a lumen that is the same size as that of a proximal portion of the sheath.

18. The method of claim 9, further comprising expanding an internal anchor carried by the sheath within the stomach.

19. The method of claim 18, further comprising expanding an external anchor carried by the sheath outside the skin of the abdomen.

20. The method of claim 19, further comprising retracting the internal and the external anchors toward each other to seal the stomach against the abdominal wall.