Apparatus for treating asthma using neurotoxin

• US 8,172,827 B2
• Filed: 06/01/2006
• Issued: 05/08/2012
• Est. Priority Date: 05/13/2003
• Status: Active Grant

• Current Assignee: Nuvaira, Inc.
• Original Assignee: Innovative Pulmonary Solutions, Incorporated
• Inventors: Deem, Mark E., Gifford, Hanson S. III
• Primary Examiner(s): Yu, Justine
• Assistant Examiner(s): YOUNG, RACHEL T
• Application Number:
  US11/445,644
• Publication Number:
  US 20060222667A1
• Time in Patent Office: 2,168 Days
• Field of Search: 604/93.01, 604/164.01, 604/164.11, 604/164.12, 604/264, 604/272, 604/500, 604506-509, 128/200.26, 128/898, 606 1- 44, 606 45- 47, 606/180, 606/183
• US Class Current: 604/506
• CPC Class Codes: A61B 1/018 for receiving instruments
• CPC Class Codes: A61B 1/04 combined with photographic or television appliances
• CPC Class Codes: A61B 1/0661 Endoscope light sources
• CPC Class Codes: A61B 1/2676 Bronchoscopes
• CPC Class Codes: A61M 11/00 Sprayers or atomisers specially adapted for therapeutic purposes in general B05B; aerosol containers B65D83/14
• CPC Class Codes: A61M 16/00 Devices for influencing the respiratory system of patients by gas treatment, e.g. mouth-to-mouth respiration; Tracheal tubes stimulating the respiratory movement by mechanical, pneumatic or electrical means, iron lungs combined with gas breathing means A61H31/00
• CPC Class Codes: A61M 2025/0086 the needles having bent tips, i.e. the needle distal tips are angled in relation to the longitudinal axis of the catheter
• 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 2202/049 Toxic
• CPC Class Codes: A61M 2210/1035 Bronchi
• CPC Class Codes: A61M 25/0084 being one or more injection needles
• 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 5/1452 pressurised by means of pistons
• CPC Class Codes: A61M 5/162 Needle sets, i.e. connections by puncture between reservoir and tube ; Connections between reservoir and tube in jet-action syringes A61M5/30; connectors for tubes having sealed ends and a needle for piercing them A61M39/14
• CPC Class Codes: A61M 5/30 Syringes for injection by jet action, without needle, e.g. for use with replaceable ampoules or carpules

Abstract

Apparatus for providing intrabronchial delivery of neurotoxins to control the effects of asthma comprises a shaft having proximal and distal ends and a neurotoxin applicator assembly disposed on the distal end. The neurotoxin applicator assembly comprises a deployable needle assembly, a rotating needle assembly, and a needle-less injection assembly or a nebulizer assembly.

Claims

1. A method for treating the bronchial airways of a patient, said method comprising:

endobronchially positioning a shaft at a location in a bronchial airway, the shaft having a plurality of needles coupled near a distal end thereof;

penetrating at least one needle from the shaft across an epithelium and a mucosa of the bronchial airway;

positioning at least a portion of the at least one needle at a treatment site outside of the mucosa, the treatment site including at least one of a smooth muscle layer of the bronchial airway and a collagenous layer of the bronchial airway; and

delivering a medication out of the at least one needle to nerve tissue at the treatment site so as to inhibit hyperresponsiveness of smooth muscle cells in the bronchial tissue while inhibiting transport of the delivered medication away from the treatment site to non-targeted tissue outside the bronchial airway.

2. The method as in claim 1, wherein the medication lessens the effects of asthma.

3. The method as in claim 2, wherein the medication comprises a neurotoxin.

4. The method of claim 3, wherein the neurotoxin comprises botulinum toxin, serotype A.

5. The method of claim 3, wherein the neurotoxin comprises botulinum toxin, serotype B.

6. The method of claim 1, wherein penetrating comprises advancing at least one needle from the shaft.

7. The method of claim 1, wherein penetrating comprises rotating a needle-bearing wheel over a wall of the bronchial airway, and injecting comprises injecting the medication through a plurality of needles in the wheel.

8. The method of claim 1, wherein penetrating and injecting comprises penetrating and injecting with a plurality of needles.

9. The method of claim 1, further comprising:

positioning an end of the at least one needle a pre-selected distance from a lumen of the bronchial airway using an injection stop, the pre-selected distance corresponding to a distance between the lumen and nerve tissue that transmits signals to the smooth muscle cells.

10. The method of claim 9, wherein positioning the end of the at least one needle comprises contacting the bronchial tissue with the injection stop, the injection stop comprising at least one of a hilt carried by the at least one needle and a wheel from which the plurality of the needles extend.

11. The method of claim 1, further comprising:

contacting the bronchial tissue of the bronchial airway with a hilt carried by the at least one needle or a wheel from which the plurality of needles extend to position an end of the at least one needle at the treatment site.

12. The method of claim 1, further comprising:

keeping an end of the at least one needle located in smooth muscle tissue of the bronchial airway while the medication is delivered out of the end of the at least one needle.

20. The method of claim 1, wherein the medication is delivered out of the at least one needle such that the medication is directly delivered to the treatment site to affect the nerve tissue while protecting the mucosa from the medication.

13. A method of treating a subject, comprising:

moving a shaft along a bronchial passageway defined by a bronchial wall, the shaft is coupled to a medication applicator including a needle assembly having at least one needle and a penetration stop, the penetration stop spaced apart from an end of the at least one needle a distance corresponding to a distance between the bronchial passageway and a nerve tissue treatment site, the nerve tissue treatment site being disposed outside a mucosal layer and being located in a smooth muscle layer of the bronchial wall or a collagenous layer of the bronchial wall;

moving the at least one needle through the mucosal layer to position the end of the at least one needle proximate to the nerve tissue treatment site; and

delivering medication through the at least one needle to the nerve tissue treatment site so as to inhibit hyperresponsiveness of the bronchial wall while the medication is inhibited from being transported away from the nerve tissue treatment site.

14. The method of claim 13, further comprising:

contacting the bronchial wall with the penetration stop to inhibit movement of the at least one needle into the bronchial wall.

15. The method of claim 14, wherein contacting the bronchial wall with the penetration stop includes moving the penetration stop in the form of a hilt coupled to the at least one needle against the bronchial wall.

16. The method of claim 13, further comprising:

moving the medication applicator from a delivery configuration to a deployed configuration to move a plurality of needles into an injection position, the plurality of needles including the at least one needle; and

penetrating the bronchial wall with the plurality of needles.

17. The method of claim 13, wherein moving the at least one needle through the mucosa and collagenous layer comprises moving a tip of the at least one needle outwardly past at least a portion of the collagenous layer towards nerve tissue that transmits signals to smooth muscle tissue of the bronchial wall.

21. The method of claim 13, wherein delivering the medication includes directly delivering the medication to the nerve tissue treatment site while inhibiting transport of the medication to the mucosal layer, and the nerve tissue treatment site comprises nerve tissue that causes hyperresponsiveness of the bronchial wall.

18. A method of treating a subject, comprising:

moving a bronchoscope along a bronchial passageway;

moving a medication applicator of an apparatus out of the bronchoscope;

moving the medication applicator from a delivery position to a deployed position such that a plurality of needles extend radially outward from a shaft of the apparatus, the medication applicator is coupled to the shaft;

penetrating a bronchial wall with the plurality of needles; and

delivering medication through at least one of the plurality of needles extending through a mucosal lager along the bronchial passageway to directly deliver the medication to a target site that comprises at least one of a collagenous layer and a smooth muscle layer such that the delivered medication at the target site inhibits hyperresponsiveness of the bronchial wall and is inhibited from moving to non-targeted tissue.

19. The method of claim 18, further comprising:

positioning an end of the at least one needle adjacent to nerve tissue of the target site to deliver the medication towards the nerve tissue that delivers signals to smooth muscle layer in the bronchial wall.

22. The method of claim 18, wherein delivering the medication further comprising directly delivering the medication to the target site to inhibit transport of the delivered medication to the mucosal layer.