MALLEABLE SLEEVE FOR BALLOON CATHETER AND ENDOSCOPIC SURGICAL METHOD

• US 20090088728A1
• Filed: 09/28/2007
• Published: 04/02/2009
• Est. Priority Date: 09/28/2007
• Status: Abandoned Application

• Current Assignee: Quest Medical Incorporated (Atrion Corporation)
• Original Assignee: Quest Medical Incorporated (Atrion Corporation)
• Inventors: Dollar, Michael L., Dubuclet, Victor A. IV
• Application Number:
  US11/864,124
• Publication Number:
  US 20090088728A1
• Time in Patent Office: Days
• US Class Current: 604/528
• CPC Class Codes: A61M 2025/0096 being laterally outward extensions or tools, e.g. hooks or fibres
• CPC Class Codes: A61M 2025/0681 Systems with catheter and outer tubing, e.g. sheath, sleeve or guide tube
• CPC Class Codes: A61M 2210/0681 Sinus (maxillaris)
• CPC Class Codes: A61M 25/0041 pre-formed, e.g. specially adapted to fit with the anatomy of body channels urethral catheters A61F2/04
• CPC Class Codes: A61M 25/0067 characterised by the distal end, e.g. tips A61M25/0054, A61M25/04 take precedence; balloon catheters A61M25/10

Abstract

The present invention is directed towards a malleable sleeve used in conjunction with a multi-lumen catheter with an expandable device, such as a balloon, incorporated into its surface. The malleable sleeve allows the catheter to be pre-formed into a shape that corresponds with the shape of the nasal passageway. The present invention also covers endoscopic surgical methods utilizing the malleable sleeve.

Claims

1. A malleable sleeve for a balloon catheter comprising:

(a) a tubular malleable shaft defining a first lumen with a proximal end and a distal end;

(b) a base connected to the proximal end of the malleable shaft and adapted to mate with a base of a multi-lumen catheter;

2. The malleable sleeve of claim 1 additionally comprising a flange built into the malleable shaft biased towards the central axis of the malleable shaft.

3. The malleable sleeve of claim 1 additionally comprising a second lumen approximately equal in length to the first lumen.

4. An endoscopic surgical method, comprising the steps of:

(a) providing a human body with a nasal system having at least one obstructed fluid pathway;

(b) providing a balloon catheter and an imaging device;

(c) providing a multi-lumen catheter with a surface, a base, a tip, an expandable device incorporated into its surface near the tip and a first, second, and third lumen, with the first lumen adapted to expanding and contracting the expandable device;

(d) providing a malleable sleeve for the multi-lumen catheter having a base adapted to mate with the base of the multi-lumen catheter;

(e) viewing the nasal system;

(f) bending the malleable sleeve into a shape approximating the nasal system;

(g) sliding the malleable sleeve over the multi-lumen catheter until the malleable sleeve base mates with the base of the multi-lumen catheter;

(h) inserting the imaging device in the third lumen of the multi-lumen catheter;

(i) inserting the malleable sleeve and multi-lumen catheter into the nasal system;

(j) guiding the multi-lumen catheter tip to the obstructed fluid pathway;

(k) inserting the balloon catheter into the obstructed fluid pathway through the second lumen;

(l) inflating the balloon catheter;

(m) deflating the balloon catheter;

(n) removing the balloon catheter from the nasal system through the second lumen;

(o) inserting the expandable device incorporated into the surface of the multi-lumen catheter into the obstructed fluid pathway;

(p) expanding the expandable device;

(q) contracting the expandable device; and

(r) removing the multi-lumen catheter and malleable sleeve from the nasal system.

5. The endoscopic surgical method of claim 4 comprising the additional step of repeating steps (p) and (q) at least once.

6. An endoscopic surgical method, comprising the steps of:

(a) providing a human body with a nasal system having at least one obstructed fluid pathway;

(b) providing a balloon catheter and an imaging device;

(c) providing a multi-lumen catheter with a surface, a base, a tip, an expandable device incorporated into its surface near the tip having a proximal end and a distal end, a first lumen, a second lumen, and third lumen, with the first lumen adapted to expanding and contracting the expandable device, and the third lumen having two openings, a first opening at the tip of the multi-lumen catheter, and a second opening in the shaft of the multi-lumen catheter near the proximal end of the expandable device;

(d) providing a malleable sleeve with a base adapted to made with the base of the multi-lumen catheter and a flange biased towards the central axis of the malleable sleeve and located approximately corresponding to the location of the second opening in the third lumen of the multi-lumen catheter;

(e) viewing the nasal system;

(f) bending the malleable sleeve into a shape approximating the nasal system;

(g) sliding the malleable sleeve over the multi-lumen catheter until the malleable sleeve base mates with the base of the multi-lumen catheter in an initial position;

(h) inserting the imaging device in the third lumen of the multi-lumen catheter;

(i) inserting the malleable sleeve and multi-lumen catheter into the nasal system;

(j) guiding the multi-lumen catheter tip to the obstructed fluid pathway;

(k) inserting the balloon catheter into the obstructed fluid pathway through the second lumen;

(l) inflating the balloon catheter;

(m) deflating the balloon catheter;

(n) removing the balloon catheter from the nasal system through the second lumen;

(o) inserting the expandable device incorporated into the surface of the multi-lumen catheter into the obstructed fluid pathway;

(p) retracting the imaging device to a point in the third lumen behind the second opening;

(q) moving the malleable sleeve into a secondary position thereby allowing the flange to bend towards the central axis of the multi-lumen catheter and into the second opening of the third lumen;

(r) sliding the imaging device past the flange and through the second opening in the third lumen of the multi-lumen catheter.

(s) expanding the expandable device;

(t) contracting the expandable device;

(u) retracting the imaging device into the third lumen of the multi-lumen catheter; and

(v) removing the multi-lumen catheter and malleable sleeve from the nasal system.

7. The endoscopic surgical method of claim 6 comprising the additional step of repeating steps (s) and (t) at least once.

8. An endoscopic surgical method, comprising the steps of:

(a) providing a human body with a nasal system having at least one obstructed fluid pathway;

(b) providing a balloon catheter and an imaging device;

(c) providing a multi-lumen catheter with a surface, a base, a tip, an expandable device incorporated into its surface near the tip having a proximal end and a distal end, a first lumen, a second lumen, and third lumen, with the first lumen adapted to expanding and contracting the expandable device;

(d) providing a malleable sleeve with at least two lumens, a first lumen with an inside diameter large enough to allow the multi-lumen catheter to pass through it, and a second lumen with an inside diameter large enough to allow the imaging device to pass through it;

(e) viewing the nasal system;

(f) bending the malleable sleeve into a shape approximating the nasal system;

(g) sliding the malleable sleeve over the multi-lumen catheter until the malleable sleeve base mates with the base of the multi-lumen catheter;

(h) inserting the imaging device in the third lumen of the multi-lumen catheter;

(i) inserting the malleable sleeve and multi-lumen catheter into the nasal system;

(j) guiding the catheter tip to the obstructed fluid pathway;

(k) inserting the balloon catheter into the obstructed fluid pathway through the second lumen;

(l) inflating the balloon catheter;

(m) deflating the balloon catheter;

(n) removing the balloon catheter from the nasal system through the second lumen;

(o) inserting the expandable device incorporated into the surface of the multi-lumen catheter into the obstructed fluid pathway;

(p) retracting the imaging device out of the third lumen;

(q) inserting the imaging device into the second lumen of the malleable sleeve;

(r) sliding the imaging device down the second lumen of the malleable sleeve until a view of the expandable device is obtained.

(s) expanding the expandable device;

(t) contracting the expandable device;

(u) retracting the imaging device out of the second lumen of the malleable sleeve; and

(v) removing the multi-lumen catheter and malleable sleeve from the nasal system.

9. The endoscopic surgical method of claim 8 comprising the additional step of repeating steps (s) and (t) at least once.