Frontal sinus spacer

• US 9,649,477 B2
• Filed: 04/30/2014
• Issued: 05/16/2017
• 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., Ha, Hung V., Chan, Randy S., Van, Nga K.
• Primary Examiner(s): Bosworth, Kami A
• Application Number:
  US14/266,002
• Publication Number:
  US 20140336575A1
• Time in Patent Office: 1,112 Days
• 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 17/3417 Details of tips or shafts, e.g. grooves, expandable, bendable; Multiple coaxial sliding cannulas, e.g. for dilating syringe needles A61M5/32; dilators A61M29/00
• CPC Class Codes: A61B 17/3421 Cannulas
• CPC Class Codes: A61B 2090/062 penetration depth
• CPC Class Codes: A61F 11/20 Ear surgery
• CPC Class Codes: A61M 2025/0008 having visible markings on its surface, i.e. visible to the naked eye, for any purpose, e.g. insertion depth markers, rotational markers or identification of type
• CPC Class Codes: A61M 2025/0226 specifically adapted for the nose
• CPC Class Codes: A61M 2025/0681 Systems with catheter and outer tubing, e.g. sheath, sleeve or guide tube
• CPC Class Codes: A61M 2025/0687 having means for atraumatic insertion in the body or protection of the tip of the sheath during insertion, e.g. special designs of dilators, needles or sheaths
• CPC Class Codes: A61M 2025/105 having a balloon suitable for drug delivery, e.g. by using holes for delivery, drug coating or membranes
• CPC Class Codes: A61M 2210/0618 Nose
• CPC Class Codes: A61M 25/0075 Valve means
• CPC Class Codes: A61M 25/0084 being one or more injection needles
• CPC Class Codes: A61M 25/04 in the body, e.g. expansible A61M25/10, A61M16/0488 take precedence
• CPC Class Codes: A61M 25/0662 Guide tubes
• 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

Abstract

Substance delivering spacer devices may comprise expandable reservoirs that are implantable in paranasal sinuses and other cavities, openings and passageways of the body to maintain patency and to provide sustained local delivery of a therapeutic or diagnostic substance. Delivery apparatus including elongate tubular members as well as shapeable distal portions and atraumatic tips are provided. Also provided are sinus penetrator devices and systems for performing ethmoidotomy procedures or for creating other openings in the walls of paranasal sinuses or other anatomical structures.

Claims

1. A substance delivering sinus spacer system for delivering a substance to a paranasal sinus, the system comprising:

(a) a curved delivery guide configured to extend through a nostril to position a distal end of the delivery guide in or near an ostium of a paranasal sinus while a proximal end of the delivery guide is located outside of the nostril;

(b) an elongate substance delivery catheter having a longitudinal axis, a proximal end and a distal end; and

(c) a substance delivering sinus spacer device extending from and in fluid communication with the distal end of the delivery catheter, wherein at least a portion of the spacer device is configured to fit within the paranasal sinus ostium, wherein the spacer device comprises;

(i) an elongate tubular shaft with an atraumatic tip,

(ii) an expandable reservoir attached to the tubular shaft, wherein the expandable reservoir is configured to receive and hold a substance after the spacer device has been positioned in the paranasal sinus ostium, and

(iii) at least two collapsible retention members, wherein the retention members are configured to maintain a position of the spacer device in the paranasal sinus ostium, wherein the retention members are positioned on the tubular shaft adjacent to the expandable reservoir and overlapping the expandable reservoir along the longitudinal axis of the tubular shaft.

2. The system of claim 1, further comprising a sheath removably disposed over the spacer device to hold the retention members in a collapsed configuration, the sheath comprising a stop at or near a proximal end of the sheath for stopping advancement of the sheath through the delivery guide.

3. The system of claim 2, wherein delivery catheter comprises a marker disposed along part of its length such that when the delivery catheter and the sheath are advanced into the delivery guide, when a distal end of the marker reaches the proximal end of the sheath the atraumatic tip of the spacer device is positioned at the distal end of the delivery guide, and when a proximal end of the marker reaches the proximal end of the sheath the collapsible retention members are positioned outside of the distal end of the delivery guide.

4. The system of claim 2, wherein the expandable reservoir comprises openings in a sidewall of the expandable reservoir, wherein each opening has a diameter of about 20 microns to about 40 microns.

5. The system of claim 1, wherein the delivery guide comprises a rigid proximal portion and a flexible, curved distal portion.

6. The system of claim 5, wherein the delivery guide further comprises a radiopaque distal tip.

7. The system of claim 1, wherein the delivery catheter is opaque and the spacer device is translucent.

8. The system of claim 1, further comprising a suture loop coupled with the spacer device for attaching the spacer device to tissue inside a nasal cavity or a frontal sinus outflow tract.

9. The system of claim 1, wherein the delivery catheter further comprises a luer connection coupled with its proximal end for coupling the delivery catheter with a source of the substance.

10. The system of claim 1, further comprising a handle removably couplable with the proximal end of the delivery guide.

11. The system of claim 1, further comprising an amount of the substance.

12. The system of claim 1, wherein the substance comprises a steroid.

13. The system of claim 1, wherein the expandable reservoir of the spacer device has a substantially cylindrical sidewall and tapered ends, openings being formed in the sidewall and the tapered ends of the reservoir such that the substance loaded into the reservoir will elute through the openings and out of the expandable reservoir.

14. The system of claim 1, wherein the retention members of the spacer device comprise looped wings.

15. The system of claim 14, wherein the retention members have a wing span of between about 13 mm and about 16 mm in an expanded configuration.

16. The system of claim 1, wherein the retention members are diametrically opposed on the tubular shaft.

17. The system of claim 1, wherein the retention members are staggered along a longitudinal dimension of the spacer device.

18. The system of claim 1, wherein the retention members are attached along a common side of the tubular shaft.

19. A substance delivering sinus spacer system for delivering a substance to a paranasal sinus, the system comprising:

(a) a curved delivery guide configured to extend through a nostril to position a distal end of the delivery guide in or near an ostium of a paranasal sinus while a proximal end of the delivery guide is located outside of the nostril;

(b) a substance delivering sinus spacer device, wherein at least a portion of the spacer device is configured to fit within the paranasal sinus ostium, wherein the spacer device comprises;

(i) an elongate tubular shaft, and

(ii) an expandable reservoir attached to the tubular shaft, wherein the expandable reservoir is configured to receive and hold a substance after the spacer device has been positioned in the paranasal sinus ostium,

wherein the spacer device is configured to deliver the substance from the expandable reservoir via one or more walls of the expandable reservoir; and

(c) at least two collapsible retention members positioned on the tubular shaft adjacent to and longitudinally overlapping the expandable reservoir along a longitudinal axis of the tubular shaft, wherein the retention members are configured to maintain a position of the spacer device in the paranasal sinus ostium.

20. A substance delivering sinus spacer system for delivering a substance to a paranasal sinus, the system comprising:

(a) a curved delivery guide configured to extend through a nostril to position a distal end of the delivery guide in or near an ostium of a paranasal sinus while a proximal end of the delivery guide is located outside of the nostril;

(b) an elongate substance delivery catheter having a proximal end and a distal end; and

(c) a substance delivering sinus spacer device extending from and in fluid communication with the distal end of the delivery catheter, wherein at least a portion of the spacer device is configured to fit within the paranasal sinus ostium, wherein the spacer device comprises;

(i) an elongate tubular shaft with an atraumatic tip,

(ii) an expandable reservoir attached to the tubular shaft, wherein the expandable reservoir is configured to receive and hold a substance after the spacer device has been positioned in the paranasal sinus ostium, and

(iii) at least two collapsible retention members, wherein the retention members are configured to maintain a position of the spacer device in a paranasal sinus ostium, wherein the retention members are positioned adjacent to the expandable reservoir and overlap the expandable reservoir; and

(d) a sheath comprising a stop at or near a proximal end of the sheath for stopping advancement of the sheath through the delivery guide;

wherein the delivery catheter comprises a marker disposed along part of its length such that when the delivery catheter and the sheath are advanced into the delivery guide, when a distal end of the marker reaches the proximal end of the sheath the atraumatic tip of the spacer device is positioned at the distal end of the delivery guide, and when a proximal end of the marker reaches the proximal end of the sheath the collapsible retention members are positioned outside of the distal end of the delivery guide.