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

• US 7,361,168 B2
• Filed: 08/04/2004
• Issued: 04/22/2008
• Est. Priority Date: 04/21/2004
• Status: Active Grant

• Current Assignee: Acclarent Incorporated (Johnson & Johnson)
• Original Assignee: Acclarent Incorporated (Johnson & Johnson)
• Inventors: Makower, Joshua, Walke, Amrish Jayprakash, Chang, John Y., Vrany, Julia D.
• Primary Examiner(s): Sirmons; Kevin C.
• Assistant Examiner(s): WITCZAK, CATHERINE
• Application Number:
  US10/912,578
• Publication Number:
  US 20050245906A1
• Time in Patent Office: 1,357 Days
• Field of Search: 604/890.1, 604/891.1, 604/891.2, 604/500, 604506-510, 604/514, 604/516, 606/196, 128/204.12, 128/898, 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 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 using a transnasally insertable implantable substance delivery device for delivering a diagnostic or therapeutic substance to a location within a paranasal sinus or paranasal sinus ostium of a human or animal subject, said method comprising the steps of:

A) providing a device that comprises i) an expandable reservoir that is initially substantially in a collapsed configuration, said collapsed configuration being sufficiently small to allow the reservoir, while in said collapsed configuration, to be inserted through a nostril of the subject and advanced to said location within a paranasal sinus or paranasal sinus ostium, said reservoir being thereafter expandable to an expanded configuration;

ii) a tube extending from said reservoir, said tube having a lumen through which a quantity of the substance may be introduced into the reservoir;

iii) a barrier through which the substance will elute from the reservoir, thereby causing the substance to be delivered to said location within the paranasal sinus or paranasal sinus ostiun; and

iv) a closure apparatus for preventing the substance from backflowing out of the tube after the substance has been introduced into the reservoir;

B) inserting the device, with the reservoir in the collapsed configuration, through a nostril of the subject and positioning the reservoir within a paranasal sinus or paranasal sinus ostim;

C) introducing a quantity of the substance through the tube and into the reservoir, thereby causing the reservoir to assume the expanded configuration; and

D) delivering at least some of the substance out of the reservoir to said location within the paranasal sinus or paranasal sinus ostium by leaving the device implanted within the paranasal sinus or paranasal sinus ostium for a period of time such that the substance will elute through the barrier.

2. A method according to claim 1 wherein the reservoir comprises a hollow cavity into which the substance is introduced.

3. A method according to claim 2 wherein at least a portion of said reservoir comprises a porous material that becomes laden with the substance.

4. A method according to claim 3 wherein the porous material is selected from the 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.

5. A method according to claim 2 wherein, in addition to said hollow cavity, the reservoir further comprises a porous material which will hold a quantity of the substance.

6. A method according to claim 5 wherein the porous material is located adjacent to the hollow cavity such that the substance may be initially introduced into the hollow cavity and thereafter absorbed or transported into the porous material.

7. A method according to claim 1 wherein the closure apparatus comprises apparatus for clamping, clipping, ligating, tying or compressing the tube after the substance has been introduced into the reservoir.

8. A method according to claim 1 further comprising the step of:

E) cutting away a portion of the tube so that the tube does not protrude outside of the subject'"'"'s nose.

9. A method according to claim 1 further comprising the step of:

E) removing the substance delivery device.

10. A method according to claim 9 wherein the substance delivery device further comprises a graspable member and wherein the method further comprises the step of grasping and pulling the graspable member to facilitate removal of the device.

11. A method according to claim 1 wherein the device is configured such that, when in the expanded configuration, the device includes at least one flow channel through which mucous or other biological fluid may drain and wherein the device is positioned such that mucous or other biological fluid drains through said at least one flow channel while the device is implanted.

12. A method according to claim 1 wherein the device has an intraostial portion that is positioned within a paranasal sinus ostium and an intrasinus portion that is positioned within a paranasal sinus, there being at least one indentation in the intraostial portion of the device and wherein the device is positioned such that at least a portion of the ostium is received within said at least one indentation when the reservoir is in its expanded configuration.

13. A method according to claim 1 wherein a delivery catheter system is used to deliver the substance delivery device, the delivery catheter system comprising:

a catheter that has a lumen and a distal opening, said transnasally insertable device being positioned within the lumen of the catheter; and

a member positioned within the lumen of the catheter proximal to the transnasally insertable device;

and wherein the method further comprises the step of;

moving at least one of said catheter and said member relative to the other so as to expel the substance delivery device out of the distal opening of the catheter.