Apparatus for toxin delivery to the nasal cavity

Patent metadata

Field	Value
Publication number	US-9511210-B2
Application number	US-75096707-A
Country	US
Kind code	B2
Filing date	May 18, 2007
Priority date	May 19, 2006
Publication date	Dec 6, 2016
Grant date	Dec 6, 2016

Abstract

Apparatus for delivering toxin and toxin fragments to a patient's nasal cavity provide for both release of the toxin and delivery of energy which selectively porates target cells to enhance uptake of the toxin. The use of energy-mediated delivery is particularly advantageous with light chain fragment toxins which lack cell binding capacity.

First claim

What is claimed is:

1. An apparatus for treating inflammation of a nasal membrane of a patient comprising:
a handle comprising a proximal section, a first member and a second member, wherein the first member and second member are connected to the proximal section and are movable from a compressed configuration closer together to an expanded configuration farther apart;
a first applicator tip coupled to the first member; and
a second applicator tip coupled to the second member;
wherein, in the compressed configuration, the first applicator tip and second applicator tip are each configured for insertion into a nostril of the patient and placement within a nasal passageway of the patient and are outwardly biased into the expanded configuration within the nasal passageway to press each applicator tip outwardly against a nasal turbinate,
wherein each applicator tip has an exterior surface with an outwardly-facing portion for contacting the turbinate and configured for preferentially delivering a toxin outwardly to a target region of nasal tissue on a wall of the turbinate and an impermeable portion extending over substantially all of an inwardly facing portion of the applicator tip which inhibits migration of the toxin inwardly away from the outwardly-facing portion to non-target regions of the nasal cavity outside the target region such that the toxin is delivered into the nasal cavity substantially only from the outwardly facing portions, thereby treating the inflammation.

2. The apparatus of claim 1 , wherein the handle further comprises a spring element.

3. The apparatus of claim 2 , wherein the spring element is either a v-shaped spring or closed-loop spring.

4. The apparatus of claim 2 , wherein the handle is configured to be arranged in a compressed delivery configuration for placement of the applicator tips within the nasal passageway and an expanded treatment configuration for delivering toxin to the region of nasal tissue.

5. The apparatus of claim 1 , wherein each applicator tip comprises a sponge.

6. The apparatus of claim 5 , wherein each applicator tip is configured to be arranged in a low volume delivery configuration for placement within the nasal passageway and an expanded volume treatment configuration for contacting the nasal turbinates within the nasal passageway.

7. The apparatus of claim 6 , wherein each applicator tip in the expanded volume treatment configuration is adapted to fit substantially within the nasal cavity of the patient.

8. The apparatus of claim 5 , wherein each applicator tip further comprises a spring element.

9. The apparatus of claim 8 , wherein each applicator tip is configured to be arranged in a compressed delivery configuration for placement within the nasal passageway and an expanded treatment configuration for delivering toxin to the region of nasal tissue.

10. The apparatus of claim 9 , wherein each applicator tip further comprises an actuator, wherein the actuator is configured for movement from an engaged position and a retracted position.

11. The apparatus of claim 10 , wherein the applicator tip is in the compressed delivery configuration when the actuator is in the engaged position.

12. The apparatus of claim 10 , wherein the applicator tip is in the expanded delivery configuration when the actuator is in the retracted position.

13. The apparatus of claim 10 further comprising an engagement element, wherein the engagement element is configured to control the movement of both actuators simultaneously.

14. The apparatus of claim 1 , wherein the impermeable portion comprises an impermeable lining which inhibits migration of the toxin to the non-target regions of the nasal cavity.

15. The apparatus of claim 1 , wherein each applicator tip further comprises a muco-adhesive pad.

16. The apparatus of claim 1 , wherein the toxin is carried by a bioresorbable coating.

17. The apparatus of claim 1 further comprising an infusion channel for delivering the toxin to the applicator tips.

18. The apparatus of claim 17 further comprising an access port, wherein the apparatus is in fluid communication with a toxin source via the access port.

19. The apparatus of claim 17 , wherein the applicator tips are configured to receive the toxin prior to being positioned in the nasal passageway.

20. The apparatus of claim 17 , wherein the applicator tips are configured to receive the toxin after being positioned in the nasal passageway.

21. The apparatus of claim 1 , wherein the toxin comprises at least one selected from the group consisting of a liquid, gel, foam, cream, lotion and lyophilized compound.

22. The apparatus of claim 1 , wherein the toxin comprises botulinum toxin.

23. The apparatus of claim 22 , wherein the botulinum toxin is selected from the group of botulinum toxins consisting of A, B, C, D, E, F and G.

24. The apparatus of claim 22 , wherein the toxin is a fragment of botulinum toxin.

25. The apparatus of claim 24 , wherein the fragment is a light chain fragment of botulinum toxin.

26. The apparatus of claim 25 further comprising an energy delivery applicator configured for delivering energy to the region of nasal tissue to enhance delivery of the toxin to the nasal tissue.

27. The apparatus of claim 26 , wherein the energy delivery applicator is adapted to deliver energy under conditions which cause poration of at least one cell in the region of nasal tissue.

28. The apparatus of claim 26 , wherein the energy delivery applicator is adapted to deliver an electric pulse.

29. The apparatus of claim 28 , wherein the electric pulse is an RF signal.

30. The apparatus of claim 26 , wherein the energy delivery applicator is adapted to deliver energy selected from the group consisting of microwave, ultrasound and x-ray.

31. A system for treating a condition associated with inflammation of a nasal membrane of a patient selected from the group consisting of rhinitis, rhinorrhea, hay fever and combinations thereof, said system comprising:
an applicator configured for (a) insertion into a nostril of the patient, (b) placement within a nasal passageway of the patient, and (c) delivering a therapeutically effective amount of a toxin to a target region of nasal tissue within the nasal cavity of the patient, the applicator having a toxin carrier configured to carry no more than a predetermined quantity of a toxin selected to be the amount necessary to provide a therapeutic effect for the condition;
a toxin contained in the toxin carrier; and
wherein the applicator comprises an inner member and outer member each having a low volume configuration for placement within the nasal passageway and an expanded volume configuration for delivering the toxin through the outer member to the nasal tissue, the inner member disposed in the outer member with an impermeable lining separating the inner and outer members to prevent the toxin from moving inward therepast, and the toxin being disposed only between the inner and outer members, and the outer member having an outwardly-facing porous surface to allow the toxin to pass through the porous surface upon expansion of the inner member,
wherein expansion of the inner member also expands the outer member such that the porous surface of the outer member contacts and delivers the toxin to the target region of nasal tissue in the expanded vo

Assignees

• Deem Mark E
• Gifford Hanson
• Kim Steven
• Salamini Alexey
• Foundry Llc

Inventors

• Deem Mark E
• Gifford Hanson
• Kim Steven
• Salamini Alexey

Classifications

• A61N1/0568

  with drug delivery · CPC title

• A61K9/0043

  Nose · CPC title

• A61N1/327

  for enhancing the absorption properties of tissue, e.g. by electroporation · CPC title

• A61B18/18

  by applying electromagnetic radiation, e.g. microwaves · CPC title

• A61B2017/00765

  Decreasing the barrier function of skin tissue by radiated energy, e.g. using ultrasound, using laser for skin perforation · CPC title