Devices, systems and methods useable for treating frontal sinusitis

• US 9,610,428 B2
• Filed: 10/16/2014
• Issued: 04/04/2017
• Est. Priority Date: 04/21/2004
• Status: Active Grant

• Current Assignee: Acclarent Incorporated (Johnson & Johnson)
• Original Assignee: Acclarent Incorporated (Johnson & Johnson)
• Inventors: Muni, Ketan P., Fernandez, Carlos F., Makower, Joshua, Chang, John Y., Facteau, William M.
• Primary Examiner(s): Hall, Deanna K
• Application Number:
  US14/515,687
• Publication Number:
  US 20150088188A1
• Time in Patent Office: 901 Days
• Field of Search: 604 9601, 604104
• 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: A61B 18/12 by passing a current through the tissue to be heated, e.g. high-frequency current
• CPC Class Codes: A61B 2017/22061 for spreading elements apart
• CPC Class Codes: A61B 2018/00577 Ablation
• CPC Class Codes: A61B 2018/00601 Cutting
• CPC Class Codes: A61M 2025/1086 having a special balloon surface topography, e.g. pores, protuberances, spikes or grooves
• CPC Class Codes: A61M 2029/025 characterised by the guiding element
• CPC Class Codes: A61M 2210/0618 Nose
• CPC Class Codes: A61M 2210/0681 Sinus (maxillaris)
• CPC Class Codes: A61M 2230/005 Parameter used as control input for the apparatus
• 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 25/0108 using radio-opaque or ultrasound markers
• CPC Class Codes: A61M 25/09 Guide wires
• 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 25/1002 characterised by balloon shape A61M25/1006, A61M25/1009 take precedence
• CPC Class Codes: A61M 29/02 Dilators made of swellable material balloon catheters for angioplasty A61M25/104
• CPC Class Codes: A61M 31/005 for contrast media

Abstract

Devices, systems and methods wherein a dilator, such as a balloon or other expandable member, is positionable within the frontal sinus ostium and adjacent frontal recess and useable to dilate the frontal sinus ostium and substantially all of the frontal sinus recess without requiring repositioning and repeated re-expansion of the dilator. One balloon catheter device of the invention comprises a catheter body that is less than about 50 cm in length (and in some embodiments less than 25 cm in length and a semi-compliant or non-compliant balloon on the catheter body. The balloon may have a working length of about 12 mm to about 30 mm and a width at its widest point when fully inflated of about 2 mm to about 7 mm. Such balloon may be constructed to withstand inflation pressures of about 12 atmospheres. In some embodiments, the dilator is advanced through or over a guide (e.g., guidewire or guide catheter) that has a preformed shape.

Claims

1. A method for dilating a frontal recess in a human or animal subject with a dilation catheter, the dilation catheter comprising a catheter shaft, a dilator positioned along a distal portion of the catheter shaft and having a sufficient length to extend through the frontal recess, the method comprising:

(a) inserting a guide into a head of the subject;

(b) advancing the guide to the frontal recess, then stopping advancement of the guide when a distal portion of the guide is positioned within or adjacent to the frontal recess;

(c) advancing the dilation catheter relative to the guide to position the dilator within the frontal recess; and

(d) expanding the dilator, wherein expansion of the dilator results in dilation of the frontal recess and at least some breakage of bone adjacent to the frontal recess.

2. The method according to claim 1, wherein the dilation catheter further comprises a guidewire lumen extending from an open proximal end of the catheter shaft to an open distal end of the catheter shaft, and the method further comprises:

(a) inserting a guidewire into the head of the subject; and

(b) advancing the dilator over the guidewire via the guidewire lumen of the dilation catheter.

3. The method according to claim 1, wherein the dilation of the frontal recess results in at least some movement of bone adjacent to the frontal recess.

4. The method according to claim 1, wherein the step of expanding the dilator is performed without removal, cutting, or ablation of tissue.

5. The method according to claim 1, further comprising the step of removing, cutting, or ablating tissue within the head of the subject.

6. The method according to claim 1, wherein inserting the guide into the head of the patient further comprises inserting the guide into a nostril of the patient.

7. The method according to claim 1, further comprising the step of retracting the guide relative to the dilation catheter prior to expansion of the dilator.

8. The method according to claim 1, further comprising the step of inserting an endoscope into the head of the patient.

9. The method according to claim 1, further comprising the step of placing a therapeutic or diagnostic substance delivering implant within the frontal recess or frontal sinus.

10. The method according to claim 1, further comprising bending at least the distal portion of the guide to a curved shape prior to insertion in the patient'"'"'s head, wherein the curved shape is substantially retained during use.

11. The method according to claim 10, wherein the step of bending occurs at the time of manufacture, wherein the guide is sufficiently rigid to maintain the curved shape until and during use.

12. The method according to claim 1, wherein the distal portion of the guide comprises a curve, wherein at least a portion of the dilation catheter is flexible to allow the dilation catheter to traverse the curve while advancing the dilation catheter relative to the guide.

13. The method according to claim 1, wherein the method is performed in combination with a functional endoscopic sinus surgery procedure.

14. The method according to claim 1, wherein expanding the dilator further comprises expanding the dilator to an expanded configuration, wherein a cross-sectional dimension of the expanded configuration is between approximately 3 mm and approximately 7 mm.

15. The method according to claim 1, wherein the dilator includes a length of approximately 12 mm to approximately 24 mm.

16. A method for dilating a frontal recess in a human or animal subject with a dilation catheter, the dilation catheter comprising a catheter shaft and a dilator positioned along a distal portion of the catheter shaft, the method comprising:

(a) inserting a guide into a head of the subject;

(b) advancing the guide into the frontal recess;

(c) advancing the dilation catheter relative to the guide to position the dilator within the frontal recess while the dilator is in a collapsed configuration;

(d) expanding the dilator to an expanded configuration while the dilator is positioned within the frontal recess; and

(e) dilating the frontal recess, wherein the act of dilating the frontal recess comprises breaking bone adjacent to the frontal recess.

17. The method according to claim 16, further comprising bending at least a distal portion of the guide to a curved shape having a bend angle prior to insertion in the head of the subject.

18. The method according to claim 17, wherein the step of bending occurs at the time of manufacture, wherein the guide is sufficiently rigid to maintain the curved shape until and during use.

19. The method according to claim 16, further comprising removing, cutting, or ablating tissue within the head of the subject.

20. A method for dilating a frontal recess in a human or animal subject with a dilation catheter, the dilation catheter comprising a catheter shaft, a dilator positioned along a distal portion of the catheter shaft, the method comprising:

(a) inserting the guide into a head of the subject;

(b) advancing the guide into the frontal recess;

(c) advancing the dilation catheter relative to the guide to position the dilator within the frontal recess; and

(d) expanding the dilator to break bone adjacent to the frontal recess, thereby dilating the frontal recess.