Expandable sheath for delivering instruments and agents into a body lumen and methods for use

• US 20050085841A1
• Filed: 09/02/2004
• Published: 04/21/2005
• Est. Priority Date: 04/24/2003
• Status: Active Grant

• Current Assignee: Medtronic Incorporated (Medtronic Plc)
• Original Assignee: Medtronic Incorporated (Medtronic Plc)
• Inventors: Mourlas, Nicholas J., Eversull, Christian S., Leefiang, Stephen A.
• Granted Patent: US 8,388,628 B2
• Time in Patent Office: Days
• US Class Current: 606/190
• CPC Class Codes: A61B 17/3431 being collapsible, e.g. made of thin flexible material A61B17/3423 takes precedence
• CPC Class Codes: A61B 17/3439 with means for changing the inner diameter of the cannula, e.g. expandable A61B17/3423, A61B17/3431 take precedence; catheters A61M25/0662
• CPC Class Codes: A61B 90/40 Apparatus fixed or close to patients specially adapted for providing an aseptic surgical environment
• 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: A61M 2025/0024 Expandable catheters or sheaths
• CPC Class Codes: A61M 2025/0681 Systems with catheter and outer tubing, e.g. sheath, sleeve or guide tube
• CPC Class Codes: A61M 2025/1095 with perfusion means for enabling blood circulation while the balloon is in an inflated state or in a deflated state, e.g. permanent by-pass within catheter shaft
• CPC Class Codes: A61M 25/0662 Guide tubes
• CPC Class Codes: A61M 25/10 Balloon catheters A61M25/0125 takes precedence; embolectomy A61B17/22032; retractors A61B17/02; inflatable balloons for placing stents or stent-grafts A61F2/958 ; stomach balloons for treatment of obesity A61F5/0003; oesophagal tubes A61J15/00
• CPC Class Codes: A61M 25/104 used for angioplasty

Abstract

Apparatus and methods are provided for delivering a guidewire, agents, and the like through an occlusion in a body vessel or other body lumen. The apparatus includes a flexible catheter or other elongate member including a proximal end, a distal end sized for insertion into a body lumen, and a first lumen extending from the proximal end to a distal region of the tubular member. An expandable sheath is provided on the distal region of the catheter that is expandable from a contracted condition to minimize a profile of the sheath to allow insertion along with the tubular member into a body lumen, to an enlarged condition wherein the sheath at least partially defines a lumen communicating with and extending distally from the first lumen of the tubular member.

Claims

1. An apparatus for delivering a guidewire through an occlusion in a body lumen, comprising:

an elongate tubular member comprising a proximal end, a distal end sized for insertion into a body lumen, and a first lumen extending from the proximal end to a distal region of the tubular member; and

an expandable sheath on the distal region of the tubular member, the sheath being expandable from a contracted condition to minimize a profile of the sheath to allow insertion along with the tubular member into a body lumen, to an enlarged condition wherein the sheath at least partially defines a lumen communicating with and extending distally from the first lumen of the tubular member.

2. The apparatus of claim 1, wherein the first lumen of the tubular member terminates at an outlet port on the distal region proximal to the distal end of the tubular member, the outlet port communicating with the sheath lumen.

3. The apparatus of claim 2, wherein the tubular member comprises a second lumen on the distal region extending from an inlet port distal to the outlet port and an opening in the distal end of the tubular member, and wherein the sheath lumen extends from the outlet port to the distal port.

4. The apparatus of claim 2, wherein the side port is located on a side wall of the tubular member.

5. The apparatus of claim 2, wherein the tubular member tapers such that the distal region has a smaller cross-section distal to the outlet port than an intermediate region of the tubular member proximal to the distal region.

6. The apparatus of claim 1, wherein the expandable sheath comprises a tubular member attached to the distal region of the tubular member.

7. The apparatus of claim 1, wherein the expandable sheath comprises a sheet including side edge attached along the distal region to at least partially define the sheath lumen.

8. The apparatus of claim 1, wherein the expandable sheath comprises a proximal inlet communicating with the first lumen of the tubular member and a distal outlet located distal to the proximal inlet.

9. The apparatus of claim 1, wherein the tubular member comprises a second lumen extending from the proximal end to the distal end of the tubular member.

10. The apparatus of claim 1, further comprising a guidewire insertable through the first lumen of the tubular member and into the sheath lumen, thereby expanding the sheath to accommodate advancing the guidewire therethrough.

11. The apparatus of claim 1, further comprising a source of inflation media coupled to the proximal end of the tubular member and communicating with the first lumen of the tubular member for delivering inflation media through the first lumen into the sheath lumen to at least partially expand the sheath.

12. An apparatus for delivery into a body lumen of a patient, comprising:

a flexible catheter comprising a proximal end, and a distal end sized for insertion into a body lumen;

an expandable sheath attached around an outer surface of the catheter, the sheath being expandable from a contracted condition to minimize a profile of the sheath, to an enlarged condition wherein at least a portion of the sheath moves away from the outer surface of the catheter to at least partially define an accessory lumen extending between the proximal and distal ends of the sheath.

13. The apparatus of claim 12, wherein the sheath comprises a lubricious material.

14. The apparatus of claim 12, wherein the sheath comprises a flimsy material.

15. The apparatus of claim 12, wherein the sheath comprises a wall thickness not more than about 0.01 inch (0.25 mm).

16. The apparatus of claim 12, wherein the sheath is attached to the outer surface of the catheter by at least one of bonding, mechanical interference, heat shrinking the sheath material, and twisting the sheath material.

17. The apparatus of claim 12, wherein the proximal end of the sheath includes one or more tabs for separating the proximal end of the sheath at least partially from the outer surface of the catheter to open the sheath lumen.

18. A method for delivering an instrument through an occlusion in a body lumen using a catheter comprising an expandable sheath extending along an outer surface of the catheter, comprising:

introducing a distal end of the catheter into the body lumen proximal to the occlusion with the sheath in a contracted condition;

advancing the distal end of the catheter through the occlusion until a distal end of the sheath is disposed distal to the occlusion;

advancing an elongate member through the sheath until a distal end of the elongate member is disposed distal to the occlusion; and

withdrawing the catheter and sheath from the body lumen.

19. The method of claim 18, wherein the elongate member comprises a guidewire, and wherein one or more instruments are advanced over the guidewire after the catheter is withdrawn to treat the occlusion.

20. The method of claim 18, wherein the distal end of the catheter comprises one or more elements for facilitating advancing the distal end through the occlusion.