Implantable devices and methods for delivering drugs and other substances to treat sinusitis and other disorders

• US 9,039,657 B2
• Filed: 09/03/2009
• Issued: 05/26/2015
• Est. Priority Date: 08/04/2004
• Status: Active Grant

• Current Assignee: Acclarent Incorporated (Johnson & Johnson)
• Original Assignee: Acclarent Incorporated (Johnson & Johnson)
• Inventors: Makower, Joshua, Chang, John Y., Vrany, Julia D., Walke, Amrish Jayprakash
• Primary Examiner(s): Mehta, Bhisma
• Assistant Examiner(s): Engel, Matthew A
• Application Number:
  US12/553,877
• Publication Number:
  US 20100114066A1
• Time in Patent Office: 2,091 Days
• Field of Search: 604/500, 604506- 10, 604/514, 604/516, 604/117, 604/96.01, 604/77, 604/192, 604/194, 606/196, 606/192, 606/194, 128/204.12, 128/898, 424/434
• US Class Current: 604/96.01
• 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 34/20 Surgical navigation systems; Devices for tracking or guiding surgical instruments, e.g. for frameless stereotaxis
• CPC Class Codes: A61B 5/06 Devices, other than using radiation, for detecting or locating foreign bodies for removing same A61B17/50 ; determining position of probes within or on the body of the patient
• 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: 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 2002/825 having longitudinal struts
• CPC Class Codes: A61F 2250/0039 differing in diameter
• CPC Class Codes: A61M 2025/0037 characterized by lumina being arranged side-by-side
• 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 2025/1052 for temporarily occluding a vessel for isolating a sector
• CPC Class Codes: A61M 2210/0681 Sinus (maxillaris)
• CPC Class Codes: A61M 25/0029 characterized by features relating to least one lumen located at the middle part of the catheter, e.g. slots, flaps, valves, cuffs, apertures, notches, grooves or rapid exchange ports catheter shaft surface irregularities A61M2025/006
• 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 31/002 : 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
• CPC Class Codes: A61M 31/005 : for contrast media
• CPC Class Codes: A61M 31/007 : Injectors for solid bodies, e.g. suppositories
• CPC Class Codes: G03G 5/0535 : Polyolefins; Polystyrenes; Waxes
• CPC Class Codes: G03G 5/0539 : Halogenated polymers
• CPC Class Codes: G03G 5/056 : Polyesters
• CPC Class Codes: G03G 5/0564 : Polycarbonates
• CPC Class Codes: G03G 5/0696 : Phthalocyanines
• CPC Class Codes: G03G 5/14726 : Halogenated polymers
• CPC Class Codes: G03G 5/14791 : Macromolecular compounds characterised by their structure, e.g. block polymers, reticulated polymers, or by their chemical properties, e.g. by molecular weight or acidity

Abstract

Implantable devices and methods for delivering drugs and other substances to locations within the body of a human or animal subject to treat or diagnose sinusitis and a variety of other disorders. The invention includes implantable substance delivery devices that comprise reservoirs and barriers that control the rate at which substances pass out of the reservoirs. The delivery devices may be advanced into the body using guidewires, catheters, ports, introducers and other access apparatus. In some embodiments the delivery devices may be loaded with one or more desired substance before their introduction into the body. In other embodiments the delivery devices are loaded and/or reloaded with a desired substance after the delivery device has been introduced into the body.

Claims

1. A method for diagnosing or treating a disorder of a paranasal sinus or paranasal sinus ostium of a human or animal subject by delivering a diagnostic or therapeutic substance into the paranasal sinus or paranasal sinus ostium, said method comprising:

causing a portion of a substance delivery device to be implanted in the paranasal sinus or paranasal sinus ostium, wherein the substance delivery device comprises;

an expandable reservoir having a collapsed configuration during advancement into the paranasal sinus or paranasal sinus ostium and is thereafter expandable to an expanded configuration by introducing the substance into the expandable reservoir, wherein the reservoir, when in the collapsed configuration, has an intraostial portion that is configured and positioned to engage at least a portion of tissue forming the paranasal sinus ostium and an intrasinus portion that resides within the paranasal sinus while the intraostial portion resides within the paranasal sinus ostium, and wherein the substance delivery device further comprises;

a removable fill tube extending from said reservoir, said fill tube having a lumen through which the substance may be introduced into the reservoir causing expansion of the reservoir, and

a barrier through which the substance which has been introduced into the reservoir subsequently passes out of the reservoir;

introducing the substance through the tube and into the reservoir while the reservoir is implanted such that its intrasinus portion is in the paranasal sinus and its intraostial portion is within the paranasal sinus ostium of that paranasal sinus, thereby causing the reservoir to assume the expanded configuration and resulting in subsequent passage of the substance through the barrier and out of the reservoir;

removing the fill tube from the reservoir and withdrawing the fill tube from the paranasal sinus or paranasal sinus ostium; and

leaving the reservoir implanted for a period of time sufficient for substance passing through the barrier and out of the reservoir to have an intended diagnostic or therapeutic effect on the paranasal sinus or paranasal sinus ostium.

2. A method as in claim 1, wherein the substance delivery device further comprises a closure apparatus for preventing the substance from backflowing out of the tube after the substance has been introduced into the reservoir.

3. A method as in claim 2, wherein the closure apparatus comprises apparatus for clamping, clipping, ligating, tying or compressing the tube after the substance has been introduced into the reservoir.

4. A method as in claim 1, wherein the reservoir comprises a cavity into which the substance is introduced.

5. A method as in claim 4, wherein at least a portion of said reservoir comprises a porous material that becomes laden with the substance.

6. A method as in claim 5, wherein the porous material is selected from group consisting of:

a sponge;

flexible polymer foams;

biodegradable polymer foams;

non-biodegradable polymer foams;

porous PLLA;

porous PLGA;

porous hydrogel;

polyvinyl alcohols;

silicone foams;

polytetrafluoroethylene;

expanded polytetraflurorethylene;

latex; and

nylon.

7. A method as in claim 4, further comprising a porous material disposed in the reservoir which will hold the substance.

8. A method as in claim 1, wherein the act of removing the removable tube comprises cutting away a portion of the tube so that the tube does not protrude outside of the subject'"'"'s nose.

9. A method as in claim 1, further comprising removing the substance delivery device.

10. A method as in claim 9, wherein removing the substance delivery device comprises grasping and pulling a graspable member of the substance delivery device.

11. A method as in claim 1, wherein the substance delivery device is configured such that, when in the expanded configuration, it includes at least one flow channel through which mucus or other biological fluid may drain, and wherein the substance delivery device is advanced to a location such that mucus or other biological fluid drains through said at least one flow channel while the substance delivery device is implanted.

12. A method as in claim 1, wherein advancing the substance delivery device comprises pushing the substance delivery device out of a distal end of a catheter using a pusher member disposed within the catheter.

13. A method for diagnosing or treating a disorder of a paranasal sinus or paranasal sinus ostium of a human or animal subject by delivering a diagnostic or therapeutic substance into the paranasal sinus or paranasal sinus ostium, said method comprising:

causing a substance delivery device to be implanted in the paranasal sinus or paranasal sinus ostium, wherein the substance delivery device comprises;

an expandable reservoir having a collapsed configuration during advancement into the paranasal sinus or paranasal sinus ostium and is thereafter expandable to an expanded configuration by introducing the substance into the expandable reservoir, wherein the reservoir, when in the collapsed configuration, has an intraostial portion that includes an annular groove configured and positioned to engage at least a portion of tissue forming the paranasal sinus ostium and an intrasinus portion that resides within the paranasal sinus while the intraostial portion resides within the paranasal sinus ostium, and wherein the substance delivery device further comprises;

a fill tube extending from said reservoir, said tube having a lumen through which the substance may be introduced into the reservoir causing expansion of the reservoir, and

a barrier through which the substance which has been introduced into the reservoir subsequently passes out of the reservoir;

introducing the substance through the fill tube and into the reservoir while the reservoir is implanted such that its intrasinus portion is in a paranasal sinus and its intraostial portion is within the paranasal sinus ostium of that paranasal sinus, thereby causing the reservoir to assume the expanded configuration and resulting in subsequent passage of the substance through the barrier and out of the reservoir;

cutting away a portion of the fill tube so that the tube does not protrude outside of the subject'"'"'s nose; and

leaving the substance delivery device implanted for a period of time sufficient for substance passing through the barrier and out of the reservoir to have an intended diagnostic or therapeutic effect on the paranasal sinus or paranasal sinus ostium.

14. A method for treating a paranasal sinus or paranasal sinus ostium said method comprising:

advancing an access apparatus into or near the paranasal sinus or paranasal sinus ostium;

advancing a substance delivery device into the paranasal sinus or paranasal sinus ostium using the access apparatus;

causing the substance delivery device to be implanted in the paranasal sinus ostium, wherein the substance delivery device comprises;

an expandable reservoir having a collapsed configuration during advancement into the paranasal sinus or paranasal sinus ostium, wherein the reservoir, when in the collapsed configuration, has an intraostial portion that includes an annular groove configured and positioned to engage at least a portion of tissue forming the paranasal sinus ostium and an intrasinus portion that resides within the paranasal sinus while the intraostial portion resides within the paranasal sinus ostium, and wherein the reservoir is configured to receive a substance and thereby expand; and

a barrier through which the substance which has been introduced into the reservoir subsequently passes out of the reservoir;

introducing the substance into the reservoir while the reservoir is implanted such that its intrasinus portion is in a paranasal sinus and its intraostial portion is within the paranasal sinus ostium of that paranasal sinus, thereby causing the reservoir to assume the expanded configuration and resulting in subsequent passage of the substance through the barrier and out of the reservoir;

removing the access apparatus from the paranasal sinus or paranasal sinus ostium; and

after removing the access apparatus, leaving the substance delivery device implanted for a period of time sufficient for the substance passing through the barrier and out of the reservoir to have a diagnostic or therapeutic effect on the paranasal sinus or paranasal sinus ostium.

15. The method of claim 14, wherein the access device is selected from a group consisting of:

guidewires, catheters, ports, and introducers.

16. The method of claim 14, wherein the reservoir comprises a self-sealing fill site in fluid communication with the reservoir.