Luminal Structure Anchoring Devices and Methods

• US 20080243151A1
• Filed: 10/04/2007
• Published: 10/02/2008
• Est. Priority Date: 04/12/2004
• Status: Active Grant

• Current Assignee: Boston Scientific Scimed, Inc. (Boston Scientific Corporation)
• Original Assignee: Xlumena, Inc. (Boston Scientific Corporation)
• Inventors: Stone, Corbett W., Binmoeller, Kenneth F.
• Granted Patent: US 8,425,539 B2
• Time in Patent Office: Days
• US Class Current: 606/153
• CPC Class Codes: A61B 1/0014 Fastening element for attaching accessories to the outside of an endoscope, e.g. clips, clamps or bands
• CPC Class Codes: A61B 1/00148 using anchoring means
• CPC Class Codes: A61B 1/041 Capsule endoscopes for imaging
• CPC Class Codes: A61B 17/0401 Suture anchors, buttons or pledgets, i.e. means for attaching sutures to bone, cartilage or soft tissue; Instruments for applying or removing suture anchors A61B17/0642 takes precedence; fixation devices for tendons or ligaments A61F2/0811
• CPC Class Codes: A61B 17/0469 Suturing instruments for use in minimally invasive surgery, e.g. endoscopic surgery
• CPC Class Codes: A61B 17/11 for performing anastomosis; Buttons for anastomosis
• CPC Class Codes: A61B 17/1114 of the digestive tract, e.g. bowels or oesophagus
• CPC Class Codes: A61B 2017/00867 shape memory effect
• CPC Class Codes: A61B 2017/0408 Rivets
• CPC Class Codes: A61B 2017/0409 Instruments for applying suture anchors
• CPC Class Codes: A61B 2017/0414 having a suture-receiving opening, e.g. lateral opening
• CPC Class Codes: A61B 2017/0454 the anchor being crimped or clamped on the suture
• CPC Class Codes: A61B 2017/0464 for soft tissue
• CPC Class Codes: A61B 2017/1139 Side-to-side connections, e.g. shunt or X-connections
• CPC Class Codes: A61N 1/05 for implantation or insertion into the body, e.g. heart electrode A61N1/06 takes precedence
• CPC Class Codes: A61N 1/36007 of urogenital or gastrointestinal organs, e.g. for incontinence control
• CPC Class Codes: A61N 1/3601 of respiratory organs

Abstract

The present invention relates to a device for endoscopy or endosonography-guided transluminal interventions whereby two luminal structures in the body may be drawn toward each other and a fluid conduit formed in between. The device may have a hollow central member to which is coupled a distal retention member and in one embodiment a proximal retention member. The retention members may each be positioned inside one of the luminal structures and expanded from a first condition to an expanded second condition having an increased radius. The length of the central member may be shortened and its diameter expanded to approximate the two retention members and thereby the luminal structures.

Claims

1. An apparatus to form an anastomosis between first and second luminal structures comprising:

a hollow central member having distal and proximal ends,

a distal anchor coupled to the distal end of said central member and adapted to penetrate a wall of said first luminal structure and a wall of said second luminal structure to be positioned in or about the second luminal structure,

a proximal anchor coupled to the proximal end of said central member and adapted to be positioned in or about the first luminal structure,

and wherein the distal and proximal anchors are capable of moving toward each other and approximating the two luminal structures.

2. The apparatus of claim 1 wherein said distal anchor can be can be expanded from a first condition to an expanded second condition having an increased radius and the central member is adapted to permit the passage of a penetrating member adapted to penetrate tissue, and the distal anchor includes a first substantially straight leg member having first and second ends coupled to a distal portion of the central member at one end,

wherein said expansion from a first condition to an expanded condition comprises curling said substantially straight leg member radially to produce an increase in a distal radius of said leg member.

3. The apparatus of claim 2 wherein said proximal anchor can be can be expanded from a first condition to a second expanded condition having an increased radius, wherein the proximal anchor includes a first substantially straight leg member having first and second ends coupled to a proximal portion of the central member at one end,

wherein said expansion from a first condition to a second expanded condition comprises curling said substantially straight leg member radially to produce an increase in a distal radius of said leg member.

4. The apparatus of claim 3 wherein the hollow central member is adapted to provide a fluid communication path between the first and second luminal structures, and wherein the central member has a first diameter which is capable of expanding to a second larger diameter.

5. The apparatus of claim 4 wherein the apparatus is removable from the first and second luminal structures.

6. The apparatus of claim 4 further comprising a valve member coupled to the proximal end of the central member configured to restrict fluid flow from the first luminal structure to the second luminal structure.

7. A method to form a fluid conduit between a distal and a proximal luminal structure comprising:

positioning a portion of a central member having a distal retention member in or about the distal luminal structure,

positioning a portion of the central member having a proximal retention member in or about the proximal luminal structure,

drawing the distal and proximal retention members toward each other such that a portion of the luminal structures are held in close approximation to each other.

8. The method of claim 7 further comprising expanding the distal retention member from a first collapsed condition to a second expanded condition having an increased radius, wherein the central member is adapted to permit the passage of a penetrating member adapted to penetrate tissue, and the distal retention member includes a first substantially straight member having first and second ends connected to a distal portion of the central member at one end,

wherein said expanding comprises curling said substantially straight leg member radially to produce an increase in a distal radius of said leg member.

9. The method of claim 8 further comprising expanding the proximal retention member in at least a portion of the proximal luminal structure from a first collapsed condition to an expanded condition having an increased radius,

wherein the proximal retention member includes a first substantially straight member having first and second ends connected to a proximal portion of the central member at one end,

wherein said expanding comprises curling said substantially straight leg member radially to produce an increase in a proximal radius of said leg member.

10. The method of claim 8 wherein the proximal retention member includes at least one first substantially straight member having first and second ends connected to a proximal portion of the central member at one end,

wherein said expanding comprises unfolding said substantially straight leg member radially to produce an increase in a proximal radius of said leg member.

11. The method of claim 9 wherein drawing the distal and proximal retention members toward each other includes moving two ends of the central member toward each other thereby shortening the length of the central member, said central member comprising two concentric hollow tubes and the shortening step includes sliding one hollow tube inside the other.

12. The method of claim 9 wherein drawing the distal and proximal retention members toward each other includes moving two ends of the central member toward each other thereby shortening the length of the central member, said shortening includes deforming the central member and expanding the diameter of the central member in response to an axial compression force.

13. The method of claim 9 wherein drawing the distal and proximal retention members toward each other includes moving two ends of the central member toward each other thereby shortening the length of the central member, said shortening includes deforming the central member and expanding the diameter of the central member by inserting an expansion device into the central member, the expansion device chosen from the group consisting of an obturator, bougie, stylet or balloon.

14. The method of claim 9 wherein drawing the distal and proximal retention members toward each other includes shortening the length of the central member, said shortening includes expanding the diameter of the central member by the removal of a restraining member or by applying thermal energy to the central member, said member comprising a shape memory alloy.

15. The method of claim 7 further comprising removing the fluid conduit from the distal and proximal luminal structures.

16. A method to form an anastomosis between a first and a second luminal structure comprising:

positioning a covered conduit between the luminal structures,

at least temporarily anchoring a distal end of said conduit to the distal luminal structure and at least temporarily anchoring a proximal end of said conduit to the proximal luminal structure,

shortening the length of the conduit to approximate the luminal structures and form a fluid channel in between.

17. The method of claim 16 wherein anchoring a distal end of said conduit to the distal luminal structure comprises expanding the radius of a distal anchor member disposed about the distal end portion of the conduit having at least one substantially straight member with first and second ends connected to a distal portion of the conduit at one end from a first collapsed state to a second expanded state wherein said expanding comprises curling the substantially straight leg member radially to produce an increase in a distal radius of said leg member.

18. The method of claim 17 wherein anchoring a proximal end of said conduit to the proximal luminal structure comprises expanding the radius of a proximal anchor member disposed about the proximal end portion of the conduit having at least one substantially straight member with first and second ends connected to a proximal portion of the conduit at one end from a first collapsed state to a second expanded state wherein said expanding comprises curling the substantially straight leg member radially to produce an increase in a distal radius of said leg member.

19. The method of claim 16 further comprising expanding the diameter of the conduit by withdrawing a constricting sheath so that the conduit can self-expand wherein the conduit is a covered stent or a covered braided tube.

20. The method of claim 16 wherein expanding the diameter includes inserting an inflatable balloon into the conduit and inflating the balloon inside the conduit.

21. The method of claim 16 further comprising expanding the diameter of the conduit by applying thermal energy to the conduit, said conduit comprising a shape memory alloy which expands in diameter in response to said thermal energy.

22. A system to form a fluid pathway between a first and a second hollow body comprising:

a hollow central member forming a lumen and having distal and proximal end portions, a distal retention member coupled to the distal end portion and a proximal retention member coupled to the proximal end portion, the distal retention member adapted to anchor inside the second hollow body and the proximal retention member adapted to anchor inside the first hollow body, such that when length of the central member