Delivery system for implanting nasal ventilation tube

• US 8,945,142 B2
• Filed: 06/10/2011
• Issued: 02/03/2015
• Est. Priority Date: 08/27/2008
• Status: Active Grant

• Current Assignee: C2Dx, Inc.
• Original Assignee: Cook Medical Incorporated (Cook Group Incorporated)
• Inventors: Schaeffer, Darin, Melder, Patrick C., Evert, Kathryn, Koehler, Cleve, Hawkins, Kem, Cherry, Thomas, Wooley, Chase
• Primary Examiner(s): Sirmons, Kevin C
• Assistant Examiner(s): CARPENTER, WILLIAM R
• Application Number:
  US13/158,063
• Publication Number:
  US 20120150119A1
• Time in Patent Office: 1,334 Days
• Field of Search: 606/108, 606/109, 606/140, 606/191, 606/192, 606/199, 623/1.11, 623/1.19, 623/1.23, 604/164.01, 604/164.06
• US Class Current: 606/108
• CPC Class Codes: A61B 17/0218 for minimally invasive surgery A61B17/0281, A61B17/0469, A61B17/12013, A61B17/1285, A61B17/29, A61B17/320016 take precedence
• CPC Class Codes: A61B 17/3415 for introducing tubes or catheters, e.g. gastrostomy tubes, drain catheters A61B17/3417 takes precedence; body piercing catheter guide needles A61M25/06
• CPC Class Codes: A61B 17/3423 Access ports, e.g. toroid shape introducers for instruments or hands access sites for liquids A61M39/0247
• CPC Class Codes: A61B 17/3468 for implanting or removing devices, e.g. prostheses, implants, seeds, wires devices for implanting seeds A61M37/0069
• CPC Class Codes: A61B 17/3478 Endoscopic needles, e.g. for infusion biopsy needles A61B10/0233; catheters with injection needles A61M25/0067
• CPC Class Codes: A61B 2017/0225 flexible, e.g. fabrics, meshes, or membranes
• CPC Class Codes: A61B 2017/3425 for internal organs, e.g. heart ports
• CPC Class Codes: A61B 2017/3437 with means for removing or absorbing fluid, e.g. wicks or absorbent pads
• CPC Class Codes: A61B 2017/345 for introduction into a natural body opening
• CPC Class Codes: A61F 2/04 Hollow or tubular parts of organs, e.g. bladders, tracheae, bronchi or bile ducts A61F2/18, A61F2/20 take precedence; devices, other than stent-grafts, providing patency to, or preventing collapsing of, tubular structures of the body other than stent-grafts, e.g. stents A61F2/82; instruments specially adapted for placement or removal of stents or stent-grafts A61F2/95
• CPC Class Codes: A61F 2210/0004 bioabsorbable
• CPC Class Codes: A61F 2250/0067 Means for introducing or releasing pharmaceutical products into the body
• CPC Class Codes: A61M 16/0463 combined with suction tubes, catheters or the like; Outside connections
• CPC Class Codes: A61M 16/0488 Mouthpieces; Means for guiding, securing or introducing the tubes guiding or introducing with laryngoscopes A61B1/267; holding devices on the body A61M25/02
• CPC Class Codes: A61M 16/0666 Nasal cannulas or tubing devices for improving normal breathing through the nose A61F5/08; nose filters A62B23/06; outside holding devices A61M25/02
• CPC Class Codes: A61M 16/0816 Joints or connectors
• CPC Class Codes: A61M 2210/0618 Nose
• CPC Class Codes: A61M 2210/0681 Sinus (maxillaris)
• CPC Class Codes: A61M 27/002 Implant devices for drainage of body fluids from one part of the body to another intraocular A61F9/00781; middle ear A61F11/202

Abstract

Delivery systems and methods of creating an accessory maxillary ostium and implanting a ventilation tube for purposes of ventilation, irrigation, infusion or procedural work are described. The delivery systems include an introducer and an associated ventilation tube. An irrigation and/or infusion catheter may be advanced through the ventilation tube in order to irrigate or express the contents of the sinus cavities. A secondary irrigation and/or infusion catheter or a balloon catheter may be advanced through an outer irrigation and/or infusion catheter, deeply into the sinus cavity, in order to irrigate or express the contents of the sinus cavities. Moreover, the balloon catheter may alternatively or additionally be employed to for dilation of the natural ostium. Still further, a device for delivering drugs, fluids or the like, may be coupled to the ventilation tube for delivery of same.

Claims

1. A delivery system comprising:

an introducer having a first proximal end and a first distal end;

a handle disposed on the first proximal end of the introducer and comprising a head member, a housing, and a finger retraction handle;

the head member disposed over the introducer and having a second proximal end, a second distal end, and a wall defining a lumen extending between the second proximal end and the second distal end;

the housing disposed over the introducer and having a third proximal end, a third distal end, and a wall defining an aperture and a cavity, the third distal end adapted to be attached to the second proximal end of the head member;

the aperture extending through the wall of the housing and providing access to the cavity, the aperture having a first opening and an opposably positioned second opening, the aperture containing a rocker arm;

the rocker arm pivotally attached within the aperture and having a first portion and an opposably positioned second portion;

the cavity in communication with the lumen of the head member and having a fourth proximal end and a fourth distal end, the cavity containing a drum and a spring;

the drum slidably disposed over the introducer and having a fifth proximal end and a fifth distal end;

the spring disposed between the fourth distal end of the cavity and the fifth distal end of the drum;

the finger retraction handle slidably disposed over the housing and having a sixth proximal end and a sixth distal end;

a cannula slidably disposed over the introducer and having a seventh proximal end, a seventh distal end, and an outside diameter, the seventh proximal end directly attached to the fifth distal end of the drum, the cannula moveable along the introducer between a first position and a second position;

a ventilation tube releasably disposed on the first distal end of the introducer, the ventilation tube having an eighth proximal end, an eighth distal end, and a wall defining a channel extending between the eighth proximal end and the eighth distal, the channel having a resting diameter and a loaded diameter;

wherein the outside diameter of the cannula is greater than the loaded diameter of the channel; and

wherein the first portion of the rocker arm extends through the first opening of the aperture and is disposed proximal to the sixth proximal end of the finger retraction handle, and the second portion of the rocker arm extends through the second opening of the aperture and is disposed proximal to the fifth proximal end of the drum.

2. The delivery system of claim 1, wherein the first distal end of the introducer defines a first introducer diameter;

and

wherein the first introducer diameter is greater than the resting diameter of the ventilation tube.

3. The delivery system of claim 1, wherein the introducer defines a bend between the first proximal end and the first distal end.

4. The delivery system of claim 3, wherein the ventilation tube is disposed on the introducer distal to the bend.

5. The delivery system of claim 1, wherein the introducer is formed of a malleable material adapted to allow a user to bend the introducer to conform to actual or expected anatomy of a bodily passage.

6. The delivery system of claim 5, wherein the cannula is formed of a malleable material adapted to allow a user to bend the cannula to conform to actual or expected anatomy of a bodily passage.

7. The delivery system of claim 1, wherein the ventilation tube comprises a drug eluting material.

8. The delivery system of claim 7, wherein the drug eluting material comprises one of antithrombogenics, antiproliferatives, antibiotics, antivirals, antifungals, or anti-inflammatories.

9. The delivery system of claim 1, wherein the ventilation tube comprises a resorbable material.

10. The delivery system of claim 1, wherein the ventilation tube has a proximal flange.

11. The delivery system of claim 10, wherein the ventilation tube has a distal flange.

12. The delivery system of claim 11, wherein the distal flange of the ventilation tube is frusto-conical.

13. The delivery system of claim 1, wherein the introducer extends through the drum and the proximal end of the introducer is attached to the housing.

14. The delivery system of claim 1, wherein the cannula extends through the spring and the seventh proximal end is directly attached to the fifth distal end of the drum.