Expandable device for treatment of a stricture in a body vessel

• US 9,138,307 B2
• Filed: 09/14/2007
• Issued: 09/22/2015
• Est. Priority Date: 09/14/2007
• Status: Active Grant

• Current Assignee: Cook Medical Technologies, LLC (Cook Group Incorporated)
• Original Assignee: Cook Medical Technologies, LLC (Cook Group Incorporated)
• Inventors: Valaie, Arman H.
• Primary Examiner(s): Nguyen, Victor
• Assistant Examiner(s): EVERAGE, KEVIN D
• Application Number:
  US11/855,611
• Publication Number:
  US 20090076593A1
• Time in Patent Office: 2,930 Days
• Field of Search: 623/1.22, 623/1.11, 623/23.72, 606/159, 606/200, 604104-107
• US Class Current: 1/1
• CPC Class Codes: A61B 17/3207 Atherectomy devices working by cutting or abrading; Similar devices specially adapted for non-vascular obstructions A61B17/32037 takes precedence; endoscopic cutting instruments A61B17/320016
• CPC Class Codes: A61B 17/320725 with radially expandable cutting or abrading elements A61B17/32075 takes precedence
• CPC Class Codes: A61B 2017/00867 shape memory effect
• CPC Class Codes: A61B 2017/00871 polymeric
• CPC Class Codes: A61B 2017/320716 comprising means for preventing embolism by dislodged material
• CPC Class Codes: A61F 2/013 Distal protection devices, i.e. devices placed distally in combination with another endovascular procedure, e.g. angioplasty or stenting
• CPC Class Codes: A61F 2002/018 made from tubes or sheets of material, e.g. by etching or laser-cutting
• CPC Class Codes: A61F 2210/0014 using shape memory or superelastic materials, e.g. nitinol
• CPC Class Codes: A61F 2230/0006 circular
• CPC Class Codes: A61F 2230/0067 conical
• CPC Class Codes: A61F 2230/0091 helically-coiled or spirally-coiled, i.e. having a 2-D spiral cross-section
• CPC Class Codes: A61M 2025/0681 Systems with catheter and outer tubing, e.g. sheath, sleeve or guide tube
• CPC Class Codes: A61M 25/00 Catheters; Hollow probes dilators A61M29/00; peritoneal catheters A61M1/285; tracheal tubes A61M16/04; for drainage A61M27/00; for uterus, vagina or rectum A61M31/00 ; for measuring or testing A61B; materials for catheters A61L29/00

Abstract

An expandable and retrievable device for treatment of a stenotic lesion in a body vessel is disclosed. The device comprises a tubular portion including a proximal end and a distal end extending from the proximal end. The tubular portion has a lumen formed therethrough between the proximal and distal ends. The device further comprises an expandable member formed helically about the tubular portion. The expandable member is configured to helically close, defining a collapsed state for delivery of the device. The expandable member is configured to helically open, defining an expanded state for treatment of the stenotic lesion in the body vessel. The expandable member has at least one filter portion that helically extends from the tubular portion at a predetermined angle. This defines a proximally faced opening when the expandable member is in the expanded state.

Claims

1. An assembly for treatment of a stricture in a body vessel, the assembly comprising:

an inner catheter having a tubular body portion;

an outer catheter having a distal end through which the inner catheter is disposed for deployment in the body vessel; and

an expandable device coaxially disposed within the inner catheter for treatment of the stricture in the body vessel, the device comprising;

a tubular portion including a proximal end and a distal end extending from the proximal end, the tubular portion having a lumen formed therethrough between the proximal and distal ends, the tubular portion having a longitudinal axis, wherein the tubular portion maintains flexibility as it is disposed through a tortuous body vessel; and

an expandable member formed helically about the tubular portion in a plurality of member portions arranged in continuous windings, the expandable member formed integrally with the tubular portion, the expandable member being configured to helically close, defining a collapsed state for delivery of the device, the expandable member being configured to helically open, defining an expanded state, in which the expandable member forms an outermost periphery of the expandable device, for treatment of the stenotic lesion in the body vessel, the plurality of member portions helically extending from the tubular portion at a predetermined angle at the outermost periphery defining a proximally faced opening having a concave shape with the predetermined angle forming a greater opening angle than an opening angle adjacent the tubular member when the expandable member is in the expanded state, the predetermined angle being between about 40 and 70 degrees, the plurality of member portions having a solid one-piece construction.

2. The assembly of claim 1 further comprising:

an introducer sheath through which the outer catheter is inserted for percutaneous insertion to the body vessel; and

a wire guide introducible through the introducer sheath to the body cavity for guidance of the inner and outer catheters to the body cavity.

3. The assembly of claim 1 wherein the predetermined angle is between about 55 and 65 degrees.

4. The assembly of claim 1 wherein the opening of each member portion has an outer diameter, the outer diameter increasing distally longitudinally relative to the tubular portion to define the expandable member having a distally flared profile.

5. The assembly of claim 1 wherein the expandable member is formed by machining the expandable member helically around the tubular portion.

6. A method for treating a stricture in a body vessel, the method comprising:

percutaneously introducing an inner catheter in the body vessel, the inner catheter having a tubular body portion;

disposing an expandable device for treatment of the stricture in the body vessel, the device being in a collapsed state coaxially within the inner catheter, the device comprising;

a tubular portion including a proximal end and a distal end extending from the proximal end, the tubular portion having a lumen formed therethrough between the proximal and distal ends, the tubular portion having a longitudinal axis, wherein the tubular portion maintains flexibility as it is disposed through a tortuous body vessel; and

an expandable member formed helically about the tubular portion in a plurality of member portions arranged in continuous windings, the expandable member formed integrally with the tubular portion, the expandable member being configured to helically close, defining a collapsed state for delivery of the device, the expandable member being configured to helically open defining an expanded state, in which the expandable member forms an outermost periphery of the expandable device, for treatment of the stenotic lesion in the body vessel plurality of member portions helically extending from the tubular portion at a predetermined angle at the outermost periphery defining a proximally faced opening having a concave shape with the predetermined angle forming a greater opening angle than an opening angle adjacent the tubular member when the expandable member is in the expanded state, the predetermined angle being between about 40 and 70 degrees, the plurality of member portions having a solid one-piece construction; and

deploying the device in the expanded state at the stricture of the body vessel to treat the stricture.

7. The method of claim 6 further comprising:

closing the device in the collapsed state in the body vessel by rotating the tubular portion in the first direction; and

retrieving the device in the collapsed state in the inner catheter.

8. The method of claim 6 wherein the predetermined angle is between about 55 and 65 degrees.

9. The method of claim 6 wherein the at least one member portion is a plurality of member portions, such that the tubular portion maintains its flexibility as it is disposed through a tortuous body vessel.

10. The method of claim 9 wherein the opening of each member portion has an outer diameter, the outer diameter increasing distally longitudinally relative to the tubular portion to define the expandable filter having a distally flared profile.

11. The method of claim 9 wherein each of the member portions separately extends from the tubular portion.

12. A method for treating a stricture in a body vessel, the method comprising:

percutaneously introducing an inner catheter in the body vessel, the inner catheter having a tubular body portion;

disposing an expandable device for treatment of the stricture in the body vessel, the device being in a collapsed state coaxially within the inner catheter, the device comprising;

a tubular portion including a proximal end and a distal end extending from the proximal end, the tubular portion having a lumen formed therethrough between the proximal and distal ends, the tubular portion having a longitudinal axis, wherein the tubular portion maintains flexibility as it is disposed through a tortuous body vessel; and

an expandable member formed helically about the tubular portion in a plurality of conical member portions arranged in continuous windings, the expandable member formed integrally with the tubular portion, the expandable member being configured to helically close, defining a collapsed state for delivery of the device, the expandable member being configured to helically open defining an expanded state, in which the expandable member forms an outermost periphery of the expandable device, for treatment of the stenotic lesion in the body vessel, the plurality of member portions helically extending from the tubular portion at a predetermined angle at the outermost periphery defining a proximally faced opening having a concave shape with the predetermined angle forming a greater opening angle than an opening angle adjacent the tubular member when the expandable member is in the expanded state, the predetermined angle being between about 40 and 70 degrees, the plurality of conical member portions having a solid one-piece construction; and

deploying the device in the expanded state at the stricture of the body vessel to treat the stricture.

13. The method of claim 12 wherein the predetermined angle is between about 55 and 65 degrees.

14. The assembly of claim 12 wherein the opening of each member portion has an outer diameter, the outer diameter increasing distally longitudinally relative to the tubular portion to define the expandable filter having a distally flared profile.

15. The method of claim 12 further comprising:

closing the device in the collapsed state in the body vessel by rotating the tubular portion in the first direction; and

retrieving the device in the collapsed state in the inner catheter.