Frontal sinus spacer

• US 10,441,758 B2
• Filed: 05/15/2017
• Issued: 10/15/2019
• 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:
  US15/595,319
• Publication Number:
  US 20170312485A1
• Time in Patent Office: 883 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 system comprising:

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

(b) a substance delivery device configured to be received within the guide device, wherein at least a distal portion of the substance delivery device is configured to fit within the paranasal sinus ostium, wherein the substance delivery device comprises;

(i) an elongate tubular shaft having a lumen,

(ii) an expandable reservoir arranged on a distal portion of the tubular shaft, wherein the expandable reservoir is configured to expand and emit a substance therefrom after the substance delivery device has been positioned in the paranasal sinus ostium, and

(iii) a retention member, wherein the retention member is transitionable between a collapsed state and an expanded state in which the retention member is configured to engage tissue and thereby maintain a position of the substance delivery device relative to the paranasal sinus ostium, wherein the retention member is biased toward the expanded state; and

(c) a sheath slidably disposed over the substance delivery device, wherein the sheath is configured to selectively hold the retention member in the collapsed state and release the retention member into the expanded state, wherein the sheath includes a stop member configured to abut a portion of the guide device to thereby limit distal translation of the sheath relative to the guide device while permitting distal translation of the substance delivery device through the sheath.

2. The system of claim 1, wherein the distal portion of the tubular shaft includes an aperture configured to establish fluid communication between the lumen and an interior of the expandable reservoir, wherein the substance delivery device further comprises a one-way valve arranged at the aperture.

3. The system of claim 2, wherein the one-way valve comprises an elastomeric sleeve valve that encircles the distal portion of the tubular shaft containing the aperture.

4. The system of claim 2, wherein the expandable reservoir encircles the distal portion of the tubular shaft containing the one-way valve and the aperture.

5. The system of claim 1, wherein the substance delivery device further comprises a first radiopaque marker arranged at a proximal end of the expandable reservoir and a second radiopaque marker arranged at a distal end of the expandable reservoir, wherein the radiopaque markers are configured to facilitate positioning of the expandable reservoir within the paranasal sinus ostium.

6. The system of claim 1, wherein the retention member is resiliently biased toward the expanded state.

7. The system of claim 1, wherein the retention member is configured to extend distally alongside at least a portion of the expandable reservoir when in the expanded state.

8. The system of claim 1, wherein the retention member comprises a looped wing.

9. The system of claim 1, wherein the sheath is slidably disposed within the guide device.

10. The system of claim 1, wherein an outer wall of the expandable reservoir includes a plurality of openings configured to emit the substance from an interior of the expandable reservoir.

11. The system of claim 10, wherein the expandable reservoir includes a tapered proximal end, a tapered distal end, and a cylindrical side wall extending therebetween, wherein the openings are formed in at least the cylindrical side wall.

12. The system of claim 10, wherein each of the openings has a diameter of about 20 microns to about 40 microns.

13. The system of claim 1, wherein the substance delivery device further includes a shaft marker arranged on the tubular shaft proximally of the expandable reservoir, wherein a longitudinal position of the shaft marker relative to the stop member of the sheath is configured to inform a user of a longitudinal position of the expandable reservoir relative to a distal end of the guide device.

14. The system of claim 1, wherein the tubular shaft includes a severable portion arranged between a proximal portion of the tubular shaft and the distal portion of the tubular shaft, wherein the severable portion is configured to be severed to separate the proximal and distal portions after positioning of the expandable reservoir within the paranasal sinus ostium.

15. The system of claim 1, wherein the guide device includes a deformable distal portion configured to assume a curved shape.

16. The system of claim 1, wherein the substance delivery device further includes a suture loop coupled to the tubular shaft, wherein the suture loop is configured to facilitate attachment of the substance delivery device to a nasal cavity or a frontal sinus outflow tract.

17. A system comprising:

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

(b) a substance delivery device slidable within the guide device, wherein at least a distal portion of the substance delivery device is configured to fit within the paranasal sinus ostium, wherein the substance delivery device comprises;

(i) a shaft having a lumen,

(ii) an expandable reservoir arranged on a distal portion of the shaft, wherein the expandable reservoir is configured to expand and emit a substance therefrom after the substance delivery device has been positioned in the paranasal sinus ostium, and

(iii) a retention member, wherein the retention member is transitionable between a collapsed state and an expanded state in which the retention member is configured to engage tissue and thereby maintain a position of the substance delivery device relative to the paranasal sinus ostium, wherein the retention member is biased toward the expanded state; and

(c) a constraint device movable relative to the guide device, wherein the constraint device is moveable relative to the substance delivery device between a first position in which the constraint device constrains the retention member in the collapsed state, and a second position in which the constraint device releases the retention member into the expanded state, wherein a portion of the constraint device is configured to engage the guide device to thereby limit movement of the constraint device relative to the guide device while permitting translation of the substance delivery device relative to the constraint device.

18. The system of claim 17, wherein the constraint device comprises a sheath slidably disposed over the substance delivery device.

19. A system comprising:

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

(b) a substance delivery device slidable within the guide device, wherein at least a distal portion of the substance delivery device is configured to fit within the paranasal sinus ostium, wherein the substance delivery device comprises;

(i) a shaft having a shaft lumen,

(ii) an inflatable member provided on a distal shaft portion of the shaft, wherein the inflatable member includes a plurality of openings that fluidly communicate with the shaft lumen,

wherein the inflatable member is configured to inflate with the substance and emit the substance through the openings, and

(iii) a retention member coupled to the shaft, wherein the retention member is transitionable between a collapsed state and an expanded state independently of inflation of the inflatable member, wherein in the expanded state the retention member is configured to engage tissue and thereby maintain a position of the substance delivery device relative to the paranasal sinus ostium; and

,

(c) a constraint device operatively coupled with the guide device and the substance delivery device,

wherein the system is actuatable through a first range of motion in which the substance delivery device and the constraint device translate distally relative to the guide device, wherein the constraint device is configured to constrain the retention member in the collapsed state throughout the first range of motion,

wherein the system is further actuatable through a second range of motion in which the substance delivery device translates distally relative to the constraint device and the guide device, wherein the constraint device is configured to disengage the retention member and permit expansion thereof toward the expanded state in response to actuation of the system through the second range of motion.

20. The system of claim 19, wherein the retention member comprises a looped wing.