Access device with expandable containment member

• US 6,210,370 B1
• Filed: 01/10/1997
• Issued: 04/03/2001
• Est. Priority Date: 01/10/1997
• Status: Expired due to Term

• Current Assignee: Applied Medical Resources Corporation (Applied Medical Corporation)
• Original Assignee: Applied Medical Resources Corporation (Applied Medical Corporation)
• Inventors: Lee, Eric, Hart, Charles C., Ashby, Mark, Chi-Sing, Eduardo
• Primary Examiner(s): Polutta, Mark O.
• Assistant Examiner(s): Thissell, Jeremy
• Application Number:
  US08/781,273
• Time in Patent Office: 1,544 Days
• Field of Search: 604/49, 604/52-53, 604/104-107, 604/164, 604/500, 606/159, 606/198, 606/200
• US Class Current: 604/164.03
• CPC Class Codes: A61B 17/22032 having inflatable gripping elements balloon catheters A61M25/10
• CPC Class Codes: A61B 17/221 Gripping devices in the form of loops or baskets for gripping calculi or similar types of obstructions surgical snare instruments A61B17/32056
• CPC Class Codes: A61B 2017/2215 having an open distal end

Abstract

An access device having a single sheath is inserted into a body passage puncture, with an expandable member of the access device held to a minimum diameter. The expandable member is held to the minimum diameter using structure that does not increase the diameter of the access device, rather than a large-diameter external sheath. The structure for holding the expandable member to a minimum diameter can subsequently be removed from the lumen of the access device., once the expandable member has been expanded.

Claims

1. An access device adapted for insertion into a body passage for removing debris from the body passage, the access device, comprising:

an outer tube having a proximal tube end, a distal tube end, and a lumen extending between the proximal tube end and the distal tube end;

an obturator assembly having a proximal obturator end and a distal obturator end, and being removably and concentrically disposed within the lumen of the outer tube;

an expandable member having a proximal member end and a distal member end, the proximal member end being connected to the distal tube end, and the distal member end being coupled to the distal obturator end;

the expandable member being expandable by relative movement between the proximal member end and the distal member end resulting from relative movement of the outer tube and the obturator assembly in opposite directions;

the distal member end having properties for being decoupled from the distal obturator end to create an opening into the expandable member; and

the opening being sufficiently large to receive the debris from the body passage.

2. The access device as recited in claim 1, wherein the outer tube is elongate and bendable to conform to the body passage.

3. The access device as recited in claim 2, the lumen of the outer tube being unobstructed when the obturator assembly is removed therefrom, to thereby facilitate insertion of instruments and removal of the debris.

4. The access device as recited in claim 3, wherein the outer tube is adapted to remove an embolus or thrombus through the lumen of the outer tube.

5. The access device as recited in claim 1 wherein the obturator assembly has a lumen, and the device further comprises a guidewire disposed within the lumen of the obturator assembly.

6. The access device as recited in claim 1, further comprising and accessory device having a port disposed in fluid communication with the lumen of the outer tube, the port having properties for applying a suction to the lumen of the outer tube.

7. The access device as recited in claim 6, further comprising a connector portion for connecting the outer tube to the accessory device, wherein the outer tube, the connector portion, and the expandable member together form a sheath assembly.

8. An access device, comprising:

an outer tube having a predetermined outer diameter, a lumen having a predetermined inner diameter, a proximal tube end, a distal tube end, and an axis extending between the proximal tube end and the distal tube end;

an expandable cone attached to the outer tube at the distal tube end, the expandable cone extending distally from the distal tube end and being moveable between an unexpanded diameter and an expanded diameter;

an obturator assembly removably disposed within the lumen of the tube and operable from the proximal end of the tube;

the obturator assembly being adjustable distally to create in situ an opening into the expandable cone; and

the obturator assembly being adjustable proximally to move the expandable cone from the unexpanded diameter to the expanded diameter.

9. The access device as recited in claim 8, wherein the obturator assembly has a lumen and the device further comprises a guidewire disposed within the lumen of the obturator assembly.

10. An access device insertable into a blood vessel for removing blood clots from the blood vessel, the access device comprising:

(a) an elongate member having an outer wall defining a lumen therein, the outer wall comprising;

(1) a first section having a predetermined diameter, a proximal end, and a distal end; and

(2) an expandable section attached to the distal end of the first section, the expandable section being expandable to an expanded diameter and being contractible to an unexpanded diameter; and

(b) an obturator assembly sized and configured for insertion into the first section of the elongate member, the obturator assembly being operable to expand the expandable section to the expanded diameter and to create in situ an axial opening sufficiently large to receive the blood clots from the expandable section of the elongate member into the first section of the elongate member.

11. The access device according to claim 10, wherein:

the obturator assembly is removable from the lumen; and

a therapeutic catheter is insertable through the lumen and into the body passage, to facilitate removal of the blood clots from the body passage into the access device.

12. A tubular access device for insertion into a body passage, comprising:

a semi-rigid portion of tubing;

an expandable portion of tubing joined to the semi-rigid portion of tubing, the expandable portion of tubing having a proximal end, a distal end, and an axis extending between the proximal end and the distal end, the expandable portion of tubing being expandable in diameter by compression along the axis and being reducible in diameter by stretching along the axis;

an obturator assembly, including a shaft and a distal tip, the obturator assembly being disposed within the semi-rigid portion of tubing and the expandable portion of tubing, with the distal tip of the obturator assembly extending beyond the expandable portion of tubing; and

the obturator assembly, including the shaft and the distal tip, being movable within the semi-rigid portion of tubing to create an axial opening in situ between the semi-rigid portion of the tubing and the expandable portion of the tubing, and thereafter to expand the expandable portion of the tubing.

13. The tubular access device as recited in claim 12, wherein the expandable portion of tubing is adapted to be reduced in diameter by stretching along the axis during insertion of the tubular access device into the body passage, and is adapted to be subsequently expanded in diameter by compression along the axis.

14. The tubular access device according to claim 12, the semi-rigid portion of tubing comprising a solid walled tubular member, the expandable portion of tubing comprising a braided tubular component, and the semi-rigid portion of tubing and the expandable portion of tubing being joined together by fusion, both the semi-rigid portion of tubing and the expandable portion of tubing having approximately equal outer diameters.

15. A method of removing an obstructing material from a body passage, comprising the following steps:

inserting a tubular access device into the body passage, the tubular access device having an expandable containment member with a proximal end and a distal end;

moving the tubular access device in a distal direction within the body passage to a first location where obstructing material is located within the body passage;

providing an obturator in contact with the distal end of the expandable containment member; and

moving the obturator in the proximal direction to move the distal end of the expandable containment member toward the proximal end of the expandable containment member and thereby expand the expandable containment member into the shape of a cone;

removing the obturator from the tubular access device;

advancing a therapeutic catheter in the distal direction through the tubular access device and past the first location where the obstructing material is located, to a second location; and

retracting the therapeutic catheter in a proximal direction from the second location toward the expandable containment member, to thereby move the obstructing material into the expandable containment member.

16. An access device for removing blood clots from a blood vessel, comprising:

an elongate tube having a lumen extending between a proximal tube end and a distal tube end;

an expandable member having a proximal member end coupled to the distal tube end and having a distal member end;

an obturator movable within the lumen of the tube and the expandable member;

a breakable attachment releasably retaining the obturator to the distal member end of the expandable member;

wherein

the obturator is movable relative to the expandable member to break the attachment and create an opening in the distal member end of the expandable member.

17. The access device recited in claim 16, wherein:

the obturator has a distal obturator end; and

the attachment releasably retains the distal obturator end of the obturator to the distal member end of the expandable member.

18. The access device recited in claim 17, further comprising:

the opening in the distal member end being smaller than the distal obturator end;

wherein

proximal withdrawal of the obturator from the expandable member causes the expandable member to expand.

19. A method for expanding the distal end of a medical access device, comprising the steps of:

providing the access device with an elongate tube having a distal tube end, and an expandable member attached to the distal tube end and having a distal member end;

creating an attachment between the obturator and the distal member end of the expansion member;

breaking the attachment between the obturator and the expansion member to create an opening into the expandable member; and

withdrawing the obturator through the expandable member to expand the distal end of the access device.

20. The method recited in claim 19 wherein the breaking step includes the step of:

moving the obturator distally relative to the expandable member to break the attachment.

21. The method recited in claim 20 wherein the withdrawing step includes the step of:

moving the obturator proximally relative to the expansion member to expand the expansion member at the distal end of the access device.