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

• US 8,388,628 B2
• Filed: 09/02/2004
• Issued: 03/05/2013
• Est. Priority Date: 04/24/2003
• Status: Active Grant

• Current Assignee: Medtronic Incorporated (Medtronic Plc)
• Original Assignee: Medtronic Incorporated (Medtronic Plc)
• Inventors: Eversull, Christian S., Mourlas, Nicholas J., Leeflang, Stephen A.
• Primary Examiner(s): Hughes, S. Thomas
• Assistant Examiner(s): SZPIRA, JULIE ANN
• Application Number:
  US10/934,305
• Publication Number:
  US 20050085841A1
• Time in Patent Office: 3,106 Days
• Field of Search: 606/190, 606/198, 606/192, 606/194, 606/108, 606/159, 604/102.03
• US Class Current: 606/108
• 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:

a catheter extending from a proximal end thereof to a distal end thereof, the catheter including a lumen, an intermediate region, a distal region, and a taper between the intermediate region and the distal region such that the distal region has a smaller cross-section than the intermediate region, the lumen of the catheter extending distally from the proximal end and through the intermediate region to terminate in an outlet port located on a sidewall of the catheter in proximity to the taper and no greater than approximately 50mm from the distal end of the catheter, and the distal region extending distally from the outlet port to the distal end of the catheter; and

two adjacent tubular bodies connected together along their lengths, a first of the tubular bodies being fitted tightly around and attached to the catheter along an exterior surface of the distal region thereof, and a second of the tubular bodies forming an entirety of an expandable sheath, the sheath being expandable from a contracted condition to an enlarged condition, at which enlarged condition the sheath defines a sheath lumen that extends along the exterior surface of the distal region of the catheter around which the first tubular body is tightly fitted, the sheath including a proximal end and a distal terminal end, the proximal end of the sheath being bonded around the outlet port of the lumen of the catheter, such that the sheath lumen communicates therewith, and the distal terminal end of the sheath being separable from the distal region of the catheter, when the sheath is expanded to the enlarged condition, such that the distal terminal end of the sheath surrounds and defines a distal opening of the sheath lumen, the distal opening being located proximal to the distal end of the catheter and facing toward the distal end.

2. The apparatus of claim 1, further comprising a guidewire insertable through the lumen of the catheter and into the sheath lumen, thereby expanding the sheath to accommodate advancing the guidewire therethrough and out the distal opening of the sheath lumen.