Devices and methods for delivering therapeutic substances for the treatment of sinusitis and other disorders

• US 8,114,062 B2
• Filed: 10/01/2009
• Issued: 02/14/2012
• 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., Makower, Joshua, Morriss, John H., Chang, John Y., Facteau, William M., Walke, Amrish Jayprakash
• Primary Examiner(s): Stigell, Theodore J
• Assistant Examiner(s): WITCZAK, CATHERINE
• Application Number:
  US12/572,137
• Publication Number:
  US 20100121308A1
• Time in Patent Office: 866 Days
• Field of Search: 604/500, 604508- 10, 604/514, 604/516, 606/196, 424/434
• US Class Current: 604/509
• 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 17/320725 with radially expandable cutting or abrading elements A61B17/32075 takes precedence
• CPC Class Codes: A61B 17/320758 with a rotating cutting instrument, e.g. motor driven A61B17/320725, A61B17/32075 and A61B17/320783 take precedence; for removing intra-ocular material A61F9/00763; endoscopic rotatable cutting instruments A61B17/32002
• CPC Class Codes: A61B 17/320783 through side-hole, e.g. sliding or rotating cutter inside catheter
• 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 2017/22061 for spreading elements apart
• CPC Class Codes: A61B 2034/105 Modelling of the patient, e.g. for ligaments or bones
• CPC Class Codes: A61B 2034/107 Visualisation of planned trajectories or target regions
• CPC Class Codes: A61B 2034/2048 using an accelerometer or inertia sensor
• CPC Class Codes: A61B 2034/2051 Electromagnetic tracking systems
• CPC Class Codes: A61B 2090/365 augmented reality, i.e. correlating a live optical image with another image
• CPC Class Codes: A61B 34/20 Surgical navigation systems; Devices for tracking or guiding surgical instruments, e.g. for frameless stereotaxis
• CPC Class Codes: A61B 5/064 using markers A61B5/062 takes precedence
• CPC Class Codes: A61B 5/411 Detecting or monitoring allergy or intolerance reactions to an allergenic agent or substance
• CPC Class Codes: A61B 5/416 the spleen
• CPC Class Codes: A61B 90/361 Image-producing devices, e.g. surgical cameras
• CPC Class Codes: A61F 2/18 Internal ear or nose parts, e.g. ear-drums implants for middle ear ventilation or drainage A61F11/202
• CPC Class Codes: A61F 2/82 Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents stent-grafts for tubular structures of the body other than blood vessels A61F2/04; stent-grafts for blood vessels A61F2/07; instruments specially adapted for placement or removal of stents or stent-grafts A61F2/95; for closing wounds, or holding wounds closed A61B17/04 - A61B17/115; dilators A61M29/00
• CPC Class Codes: A61F 2/92 Stents in the form of a rolled-up sheet expanding after insertion into the vessel , e.g. with a spiral shape in cross-section
• CPC Class Codes: A61F 2210/0076 multilayered, e.g. laminated structures
• CPC Class Codes: A61F 2220/005 : using adhesives
• CPC Class Codes: A61F 2220/0058 : soldered or brazed or welded
• CPC Class Codes: A61F 2220/0075 : sutured, ligatured or stitched, retained or tied with a rope, string, thread, wire or cable
• CPC Class Codes: A61F 2250/0039 : differing in diameter
• CPC Class Codes: A61M 2025/004 : characterized by lumina being arranged circumferentially
• CPC Class Codes: A61M 2025/1052 : for temporarily occluding a vessel for isolating a sector
• CPC Class Codes: A61M 25/007 : Side holes, e.g. their profiles or arrangements; Provisions to keep side holes unblocked
• 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 31/00 : Devices for introducing or retaining media, e.g. remedies, in cavities of the body A61M25/00 takes precedence ; introducing or retaining ophthalmic products into the ocular cavities A61F9/0008
• CPC Class Codes: A61M 31/002 : Devices for releasing a drug at a continuous and controlled rate for a prolonged period of time artificial gland structures or devices A61F2/022; intra-uterine contraceptive devices A61F6/14; tampons for introducing into the vagina A61F13/20, A61L15/00; suppositories or bougies for intra-vaginal or intra-uterine application A61K9/02; physical forms of medicinal preparations for sustained or differential drug release A61K9/20, A61K9/50

Abstract

Devices and methods for delivering drugs and other therapeutic or diagnostic substances to desired locations within the bodies of human or non-human animal subjects. An implantable delivery device comprising a reservoir is initially attached to a deliver catheter or delivery tool and is introduced into the body and positioned at a desired site. A therapeutic or diagnostic substance is then introduced into the reservoir and the delivery catheter or deliver tool is then removed, leaving the implantable delivery device implanted within the body. The substance is then delivered from the reservoir at a rate that causes the desire diagnostic or therapeutic effect. Also provided are substance eluting stents that elute substance from a selected surface of the stent (e.g., the outer surface) but not from another surface of the stent (e.g., the inner surface).

Claims

1. A method for delivering a substance into a paranasal sinus of a subject, the method comprising:

advancing an expandable reservoir, in an unexpanded configuration, into a paranasal sinus of the subject, the reservoir being coupled with a reservoir filling tube having a lumen through which the substance is introduced into the reservoir, the reservoir having a barrier that controls the rate at which the substance passes out of the reservoir;

introducing a substance through the lumen of the reservoir filling tube and into the reservoir, thereby causing the reservoir to fill and expand;

detaching the reservoir filling tube from the reservoir; and

removing the reservoir filling tube from the subject, thus leaving the reservoir behind such that the substance will pass out of the reservoir through the barrier of the expandable reservoir at a predetermined rate.

2. The method of claim 1, wherein the paranasal sinus includes an ostium of the paranasal sinus.

3. The method of claim 1, wherein the substance is a therapeutic substance.

4. The method of claim 3, wherein the therapeutic substance comprises a drug.

5. The method of claim 4, wherein the barrier is adapted to release the drug from the reservoir over an extended period of time.

6. The method of claim 5, wherein the extended period of time ranges from about 30 minutes to about 60 days.

7. The method of claim 1, wherein the substance is a diagnostic substance.

8. The method of claim 1, wherein the reservoir, when filled, has a size and shape adapted to engage a paranasal sinus wall in a manner that limits movement of the reservoir.

9. The method of claim 8, wherein the reservoir, when filled, is too large to pass through an opening of the paranasal sinus.

10. The method of claim 1, further comprising preventing the substance from backflowing out of the reservoir after removal of the tube.

11. The method of claim 10, wherein the reservoir comprises a reservoir lumen in fluid communication with the lumen of the tube, and wherein preventing the substance from backflowing out of the reservoir comprises preventing the substance from flowing out of the reservoir lumen.

12. The method of claim 11, wherein the step of preventing backflow comprises a closure mechanism in the reservoir lumen closing.

13. The method of claim 12, wherein the closure mechanism comprises a one-way valve.

14. The method of claim 1, further comprising viewing a marker on the tube during advancement of the reservoir to approximate a location of the reservoir relative to the paranasal sinus.

15. The method of claim 1, further comprising anchoring the reservoir to tissue of the subject.

16. The method of claim 1, wherein the barrier comprises an expandable outer wall of the reservoir having multiple apertures, and wherein the substance passes out of at least some of the apertures at the predetermined rate.

17. The method of claim 1, wherein the reservoir is at least partially biodegradable.

18. The method of claim 1, wherein the substance is selected from the group consisting of:

an imageable contrast agent;

a diagnostic indicator agent;

an antibiotic;

an antifungal;

an antiparasitic;

an antimicrobial;

a steroid;

a vasoconstrictor;

a leukotriene inhibitor;

an IgE inhibitor;

an anti-inflammatory;

a mast cell stabilizer;

an antihistamine;

an immunomodulator;

a chemotherapeutic agent;

an antineoplastic agent;

a mucolytic agent;

an agent that thins or otherwise changes the viscosity of mucus; and

a substance that facilitates remodeling of soft tissue and/or bone and/or cartilage.

19. The method of claim 1, wherein the reservoir comprises a tubular member forming a reservoir lumen and a one-way valve in the lumen, wherein introducing the substance comprises introducing it through the reservoir lumen and the one-way valve into the reservoir.

20. The method of claim 1, wherein the reservoir filling tube further comprises a guidewire lumen, and wherein the method further comprises:

inserting a guidewire into the paranasal sinus before advancing the reservoir; and

advancing the reservoir filling tube over the guidewire to advance the reservoir into the paranasal sinus.

21. The method of claim 20, wherein the guidewire lumen extends from a distal opening in a distal end of the reservoir to a proximal opening in a proximal end of the reservoir filling tube.

22. The method of claim 20, wherein the guidewire lumen extends from a distal opening in a distal end of the reservoir to a side opening located between proximal and distal ends of the reservoir filling tube.

23. The method of claim 1, wherein detaching the reservoir filling tube from the reservoir comprises cutting the filling tube.