Transintimal recanalisation device

• US 5,910,133 A
• Filed: 02/12/1996
• Issued: 06/08/1999
• Est. Priority Date: 04/13/1993
• Status: Expired due to Fees

• Current Assignee: Allegiance Healthcare Corp. (Cardinal Health, Inc.)
• Original Assignee: Allegiance Healthcare Corp. (Cardinal Health, Inc.)
• Inventors: Gould, Derek Alan
• Primary Examiner(s): Stright, Ronald
• Assistant Examiner(s): NGUYEN, ANH TUAN TUONG
• Application Number:
  US08/532,700
• Time in Patent Office: 1,212 Days
• Field of Search: 604/164, 604/165, 604/166, 604/171, 604/281, 604/198, 604/272
• US Class Current: 604/170.03
• CPC Class Codes: A61B 17/320725 with radially expandable cutting or abrading elements A61B17/32075 takes precedence
• CPC Class Codes: A61B 17/32075 Pullback cutting; combined forward and pullback cutting, e.g. with cutters at both sides of the plaque
• CPC Class Codes: A61B 2017/00469 for insertion of instruments, e.g. guide wire, optical fibre
• CPC Class Codes: A61B 2017/2929 with a head rotatable about the longitudinal axis of the shaft
• CPC Class Codes: A61B 2017/320741 for stripping the intima or the internal plaque from a blood vessel, e.g. for endarterectomy
• CPC Class Codes: A61B 90/39 Markers, e.g. radio-opaque or breast lesions markers
• CPC Class Codes: A61M 25/06 Body-piercing guide needles or the like

Abstract

A transintimal recanalization device comprising a guide tube (2) having a bend (C) in its length, a flexible needle (1) having a bevelled end (A) and a bend (C'"'"') in its length and located in said tube (2), wherein said needle (1) is movable from a covered position wherein said bevelled end (A) is within the tube (2) to an uncovered position in which said bevelled end (A) is exposed, and wherein said bends (C, C'"'"') match thereby orientating the bevelled end with respect to the tube (2). The device finds particular application in breaking through a vessel intima into a targeted distal vessel lumen in order to allow the passage of a guidewire.

Claims

1. A transintimal recanalisation device comprising:

a guide tube having a bend in its length, a flexible hollow needle having a bevelled end and located in said tube, wherein said needle is movable from a covered position wherein said bevelled end is within the tube to an uncovered position in which said bevelled end is exposed and has a bend in its length which conforms with the bend in the tube thereby enabling said bevelled end to adopt a desired orientation with respect to the tube;

means for manoeuvering the needle with respect to the tube, said manoeuvering means including a first body connected to an end of said needle spaced from the bevelled end, said first body having a first aperture therethrough in communication with said needle;

a second body connected to an end of said tube wherein said second body is provided with a first aperture therethrough to allow the passage of said needle;

wherein said first or second body has a second aperture extending from said first aperture to a surface of the body; and

wherein said first and second bodies are provided with cooperating alignment means whereby cooperation of said means results in the bevelled end of the needle adopting a desired orientation, said alignment means including a cooperating protrusion and recess; and

said first and second bodies further including means for indicating the relative position of the bevelled end of the needle with respect to an end of said tube spaced from said second body; and

,

wherein said indicating means is provided by the cooperation of a protrusion with one of at least two spaced apart apertures.

2. A device as claimed in claim 1, wherein said first and second bodies form a luer arrangement.

3. A device according to claim 2, wherein said needle or said tube is or are formed from a material having shape memory properties such that the needle or tube will adopt said bend at a given temperature.

4. A device as claimed in claim 3, wherein said material is a nickel titanium alloy.

5. A method of assembling a flexible transintimal recanalisation device adapted to be guided through the vasculature of a patient having a guide tube (2), a flexible needle (1) having a bevelled end (A) and located in said tube (2), a body (4) connected to an end of the needle (1) spaced from said bevelled end (A) and means for enabling the bevelled end (A) to adopt a desired orientation with respect to the tube (2) wherein said method comprises the steps of threading the end of the needle (1) spaced from said bevelled end (A) through the guide tube (2) until it extends beyond an end of the tube (2) and connecting said body (4) to the end of the needle (1).

6. A method of assembling a transintimal recanalisation device having a guide tube with a bend in its length, a flexible hollow needle having a bevelled end and located in said tube and means for enabling the bevelled end to adopt a desired orientation with respect to the tube wherein said method comprises the steps of threading a stylette into the needle until an end of the stylette extends beyond the bevelled end of the needle, inserting the needle and stylette into the tube until a desired position is reached and withdrawing the stylette.

7. A transintimal recanalisation device comprising:

a guide tube having a bend in its length, a flexible hollow needle having a bevelled end and located in said tube, wherein said needle is movable from a covered position wherein said bevelled end is within the tube to an uncovered position in which said bevelled end is exposed and has a bend in its length which conforms with the bend in the tube thereby enabling said bevelled end to adopt a desired orientation with respect to the tube, wherein said needle or said tube is formed from a material having shape memory properties such that the needle or tube will adopt said bend at a given temperature;

means for manoeuvering the needle with respect to the tube, wherein said manoeuvering means includes a first body connected to an end of the needle spaced from the bevelled end;

a second body connected to an end of said tube and wherein said second body is provided with a first aperture therethrough to allow the passage of said needle;

wherein said first and second bodies have means for indicating the relative position of the bevelled end of the needle with respect to an end of the tube spaced from said second body; and

wherein said indicating means is provided by the cooperation of a protrusion with one of at least two spaced apart apertures.