SYSTEMS, DEVICES AND METHODS FOR ACCESSING A BODILY OPENING

• US 20090312788A1
• Filed: 05/15/2009
• Published: 12/17/2009
• Est. Priority Date: 05/15/2008
• Status: Active Grant

• Current Assignee: Cook Medical Incorporated (Cook Group Incorporated)
• Original Assignee: Wilson-Cook Medical Incorporated (Cook Group Incorporated)
• Inventors: INGRAM, KIMBERLY K., HASHIBA, KIYOSHI, SURTI, VIHAR C.
• Granted Patent: US 9,028,523 B2
• Time in Patent Office: Days
• US Class Current: 606/198
• CPC Class Codes: A61B 17/3421 Cannulas
• CPC Class Codes: A61B 17/3423 Access ports, e.g. toroid shape introducers for instruments or hands access sites for liquids A61M39/0247
• CPC Class Codes: A61B 17/3431 being collapsible, e.g. made of thin flexible material A61B17/3423 takes precedence
• CPC Class Codes: A61B 2017/00278 Transorgan operations, e.g. transgastric
• CPC Class Codes: A61B 2017/3419 Sealing means between cannula and body
• CPC Class Codes: A61B 2017/3425 for internal organs, e.g. heart ports

Abstract

Medical systems, devices and methods are provided for accessing a bodily opening that, among other things, are safe and reliable, and facilitate manipulation of a medical instrument. The medical access device generally includes an elongated flexible sheath and an expandable frame connected to the distal end of the flexible sheath. The sheath and expandable frame are operable between expanded and collapsed configurations to provide a pathway from a natural orifice to the bodily opening. Medical systems and methods are also provided for delivering the medical device.

Claims

1. A medical device for forming a pathway from an external orifice to a bodily opening defined by tissue of an internal bodily lumen, the medical device comprising:

an expandable frame operable between a collapsed configuration and an expanded configuration; and

a flexible sheath having a length suitable for forming the pathway, a distal portion of the sheath connected to the expandable frame, the sheath collapsible over a substantial portion of its length and operable between a collapsed configuration and an expanded configuration.

2. The medical device of claim 1, wherein the flexible sheath folds onto itself in the collapsed configuration.

3. The medical device of claim 1, wherein the sheath has an expanded diameter in its expanded configuration, and the expandable member has an expanded diameter in its expanded configuration, the expanded diameter of the sheath being about equal to the expanded diameter of the expandable member.

4. The medical device of claim 1 wherein the expandable member exerts a radially outward force on the sheath in their respective expanded configurations.

5. The medical device of claim 4, wherein the radially outward force is sufficient to affix the distal end of the sheath to the tissue.

6. The medical device of claim 1, wherein the expandable member includes first, second and third cages, and wherein the first and third cages are stents, and wherein the second cage includes a plurality of strands extending longitudinally between the first and third cages to connect the cages and space the cages apart.

7. The medical device of claim 1, wherein the expandable member has a cylindrical portion connected to a first conical portion.

8. The medical device of claim 7, the expandable member further comprising a second conical portion, the first and second conical portions being attached on opposite sides of the cylindrical portion.

9. The medical device of claim 1, wherein a distal portion of the sheath is connected to a distal end of the expandable member.

10. The medical device of claim 1, wherein a distal portion of the sheath wraps around a distal end of the expandable member to enclose the expandable member within the distal portion of the sheath.

11. The medical device of claim 1, wherein the expandable frame includes at least one wire and a coating that encapsulates the at least wire, the coating extending beyond a proximal end of the at least one wire to define a lip, a distal end of the sheath being bonded to the lip of the coating.

12. A medical system for forming a pathway from an external orifice to a bodily opening defined by tissue of an internal bodily lumen, the medical system comprising:

an outer catheter defining an outer catheter lumen;

a medical device comprising a connection member and a flexible sheath, the flexible sheath defining a sheath lumen and having a length suitable for forming the pathway, the sheath having a distal portion connected to the connection member, the sheath operable between a collapsed configuration and an expanded configuration, the collapsed configuration of the sheath sized to be received within the outer catheter lumen; and

an inner catheter sized to be received within the sheath lumen in the collapsed configuration of the sheath, the inner catheter having a plurality of gripping members positioned on the outer periphery of the inner catheter for gripping the sheath.

13. The medical system of claim 12, wherein the plurality of gripping members are longitudinally spaced apart along the length of the inner catheter.

14. The medical system of claim 12, wherein the plurality of gripping members are each formed by an elastomeric ring bonded to the exterior of the inner catheter.

15. The medical system of claim 12, wherein the inner catheter defines an inner catheter lumen, and further comprising a guiding catheter sized to be received within the inner catheter lumen, the guiding catheter defining a guiding lumen sized to receive a wire guide.

16. A method for accessing a bodily opening defined by tissue of an internal bodily lumen via an external orifice, the method comprising:

providing a medical device comprising an expandable member and a flexible sheath, the flexible sheath defining a sheath lumen and having a length suitable for forming the pathway, the sheath having a distal portion connected to the expandable member, the sheath operable between a collapsed configuration and an expanded configuration, the expandable member operable between a collapsed configuration and an expanded configuration;

delivering the distal end of the sheath and a portion of the expandable member within the bodily opening while the expandable member is in its collapsed configuration; and

operating the expandable member to its expanded configuration such that the distal end of the sheath is placed in contact with the interior of the perforation formed in the bodily wall.

17. The method of claim 16, wherein the sheath is pressed against the interior of the bodily opening to create a fluidic seal.

18. The method of claim 16, wherein the medical device forms part of a medical system that further includes an outer catheter defining an outer catheter lumen that receives the medical device, and an inner catheter sized to be received within the sheath in its collapsed configuration, the inner catheter having a plurality of gripping members positioned on the outer periphery of the inner catheter for gripping the sheath, and wherein the step of operating the expandable member to its expanded configuration includes proximally retracting the outer catheter relative to the inner catheter.

19. The method of claim 16, wherein the esophagus forms part of the bodily lumen, and wherein the sheath has a diameter greater than a diameter of the esophagus.

20. The method of claim 19, wherein the sheath is structured to collapse under a radial force that is less than the radial force exerted by the esophagus on the sheath.