Transnasal method and catheter for lacrimal system

• US 20040064083A1
• Filed: 09/30/2002
• Published: 04/01/2004
• Est. Priority Date: 09/30/2002
• Status: Active Grant

• Current Assignee: Bruce B Becker
• Original Assignee: Bruce B Becker
• Inventors: Becker, Bruce B.
• Granted Patent: US 7,169,163 B2
• Time in Patent Office: Days
• US Class Current: 604/19
• CPC Class Codes: A61B 17/24 for use in the oral cavity, larynx, bronchial passages or nose for medical inspection of cavities or tubes in the body A61B1/00; Tongue scrapers
• CPC Class Codes: A61F 9/00772 Apparatus for restoration of tear ducts
• CPC Class Codes: A61M 2025/1093 having particular tip characteristics
• CPC Class Codes: A61M 2210/0618 Nose
• CPC Class Codes: A61M 29/02 Dilators made of swellable material balloon catheters for angioplasty A61M25/104

Abstract

A balloon catheter for treatment of a patient'"'"'s lacrimal system is applied transnasally without the use of a guide wire or a curve retention member. The catheter is formed of a stainless steel hypotube and is of sufficient stiffness and column strength to enable the deflated catheter to be pushed from the patent'"'"'s nasal cavity through a prepared small-tight opening, which is formed through the lateral nasal wall and lacrimal fossa, into the lacrimal sac. The catheter has a proximal shaft and a distal segment positioned by a bend at an angle of 70° to 115°, preferably 90°, to the proximal shaft. An inflatable member is mounted about the distal segment and is adhesively bonded to the distal end of the proximal shaft, the bend, and the proximal end of the distal segment and to the distal portion of the distal segment. The prepared, small-tight opening is formed by pushing small holes through the medial sac, lacrimal fossa, and lateral nasal wall with an instrument and coalescing the holes to form the prepared small-tight opening. The catheter is introduced into the nasal cavity and rotated, or moved, to align the distal segment with the prepared opening. The distal segment is then pushed through the prepared opening, and fluid under pressure is applied to the catheter to inflate the inflatable member and dilate the prepared opening.

Claims

2-1. A balloon catheter of claim 1, wherein said catheter body is formed of stainless steel with a wall thickness of at least 0.035″

.

3-2. A balloon catheter of claim 2, wherein said catheter body has an outer diameter of 0.083″

and an inner diameter of 0.039″

with a wall thickness of 0.044″

4-3. A balloon catheter of claim 1, wherein said distal segment has a rounded bend placing said distal segment at the angle of 70°

to 115°

to said proximal segment.

8. A balloon catheter for dilating a prepared opening in a lateral nasal wall separating a patient'"'"'s lacrimal sac and the patient'"'"'s nasal cavity, comprising:

a tubular catheter body having a proximal end, a proximal segment, a distal end, and a distal segment;

an inflatable member disposed about said distal segment, said distal segment having a slot;

said catheter body being closed at a point that is closer to said distal end that is said slot;

means for applying fluid under pressure to said proximal end of said catheter body, said fluid under pressure flowing through said slot to inflate said inflatable member for dilating said prepared opening; and

said distal segment having a rounded bend placing said distal segment at an angle of 70°

to 115°

to said proximal segment.

9. A balloon catheter of claim 8, wherein said distal segment is at an angle of 90°

to said proximal segment.

10. A balloon catheter of claim 8, wherein said inflatable member comprises a distal neck, a center region, and a proximal neck and said proximal neck is adhesively bonded to the proximal end of said distal segment and said bend, said distal neck is adhesively bonded to the portion of said distal segment between said slot and said distal end, thereby allowing a greater length of said center region to be on said distal segment.

11. A balloon catheter of claim 8, wherein said inflatable member comprises a distal neck, a center region, and a proximal neck and said proximal neck is adhesively bonded to the proximal end of said distal segment, the distal end of said proximal segment, and said bend, said distal neck is adhesively bonded to the portion of said distal segment between said slot and said distal end, thereby allowing a greater length of said center region to be on said distal segment.

12. A method forming a relatively large opening in a lateral nasal wall separating a patient'"'"'s lacrimal sac and nasal cavity, comprising:

providing a balloon catheter having a tubular catheter body formed with a proximal segment, a bend, and a distal segment at an angle of 70°

to 115°

with said proximal segment, an inflatable member mounted around said distal segment, a slot through a wall of said distal segment within said inflatable member, said tubular catheter body being closed at a point distally of said slot, and means for providing fluid under pressure at the proximal end of said tubular catheter body to inflate said inflatable member;

forming a small, tight prepared opening through the patient'"'"'s medial sac wall and lacrimal fossa, and said lateral nasal wall with one or more surgical tools, said opening being of such size that it will snugly receive said distal segment with said inflatable member deflated;

pushing said distal segment of said catheter body into said prepared opening with said inflatable member deflated; and

introducing said fluid under pressure through said proximal end of said catheter body and said slot to inflate said inflatable body and dilate said prepared opening.

13. The method of claim 12, further comprising deflating said inflatable body, slightly repositioning said distal segment and re-inflating said inflatable member to insure thorough dilation of said prepared opening.

14. The method of claim 12, wherein said inflatable member is inflated to nine bars for twenty seconds.

15. The method of claim 12, wherein said step of forming said prepared opening comprises bringing a Bowman probe through the patient'"'"'s superior punctum, superior canaliculus, common canaliculus, and lacrimal sac and pushing said probe through the patient'"'"'s medial sac wall, lacrimal fossa bone, and lateral nasal wall into the patient'"'"'s nasal cavity to form a small opening.

16. The method of claim 15, further comprising repeating said pushing of said probe to form several small openings through said medial sac wall, lacrimal fossa bone, and lateral nasal wall into said nasal cavity.

17. The method of claim 16, further comprising coalescing said several small openings to form said prepared openings by moving said probe in a see-saw fashion within said several openings.

18. The method of claim 16, further comprising coalescing said several small openings to form said prepared opening by bringing a nerve hook across said several small openings.

19. The method of claim 12, wherein said catheter body is formed of a hypotube of sufficient stiffness and column strength to enable said distal segment with said inflatable member deflated to be pushed through said prepared opening.

20. The method of claim 12, wherein said proximal segment is introduced into a patient'"'"'s nasal cavity until said distal segment is moved to a point adjacent said prepared opening, and said proximal segment is rotated to align said distal segment with said prepared opening to facilitate entry of said distal segment into said prepared opening.

21. The method of claim 12, wherein said tubular catheter body is closed at a point short of the distal end of said catheter body to provide an open-ended portion of said distal segment, and wherein said method further comprises inserting a probe into said open-ended portion to facilitate movement of said distal segment to a desired location.

22. A method forming a relatively large opening in a lateral nasal wall separating a patient'"'"'s lacrimal sac and nasal cavity, comprising:

providing a balloon catheter having a tubular catheter body formed with a proximal segment and a distal segment, an inflatable member mounted around said distal segment, a slot through a wall of said distal segment within said inflatable member, said tubular catheter body being closed at a point distally of said slot, and means for providing fluid under pressure at the proximal end of said tubular catheter body to inflate said inflatable member, said catheter body being formed of a hypotube of sufficient stiffness and column strength to enable said catheter, when said inflatable member is deflated, to be pushed from said nasal cavity through a small, tight prepared opening into said lacrimal sac;

forming a prepared opening through said lateral nasal wall with one or more surgical tools, said opening being of such size that it will snugly receive said distal segment with said inflatable member deflated;

pushing said distal segment of said catheter body into said prepared opening with said inflatable member deflated; and

introducing said fluid under pressure through said proximal end of said catheter body and said slot to inflate said inflatable body and dilate said prepared opening.

23. The method of claim 22, further comprising deflating said inflatable body, slightly repositioning said distal segment and re-inflating said inflatable member to insure thorough dilation of said prepared opening.