IP Library › Granted Patent US 12,403,291
Granted Patent B2
US 12,403,291 · App. 17/004,753 · Granted Sep 2, 2025

Submucosal bioresorbable drug eluting platform

Inventors: John Joseph Stankus (San Jose, CA); James Su (Newark, CA); Anthony J. Abbate (Campbell, CA); Tu Duc Ngo (San Jose, CA); Diego Javier Garnica (Sunnyvale, CA); Rahul Bitla (Fremont, CA)
Assignee: Intersect ENT, Inc.
A61M31/00A61K9/7007A61K31/58A61K47/34A61M2210/0618A61M2210/065A61M2210/0656A61M2210/0662A61M2210/0668A61M2210/0675A61M2210/0681A61M2210/1028A61M2210/1032A61M2210/105
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Quick Facts
Patent No.
US 12,403,291
App. No.
17/004,753
Granted
Sep 2, 2025
Kind
B2
Abstract

Systems and methods for delivering a therapeutic agent to target tissue using a plurality of drug delivery platforms each having a polymer scaffold and the therapeutic agent contained within the polymer scaffold. Each drug delivery platform of the plurality of drug delivery platforms is implanted into the target tissue, allowing the therapeutic agent to elute from each drug delivery platform of the plurality of drug delivery platforms for a target period of time, delivering a therapeutic dose of the therapeutic agent for the target period of time. Each drug delivery platform of the plurality of drug delivery platforms is allowed to biodegrade within the target tissue.

Claims (38)

1. A method for treating symptoms of a condition, the method comprising:

inserting a distal tip of a needle submucosally into a target tissue;

delivering a plurality of bioresorbable drug delivery platforms from the needle into the target tissue, each of the bioresorbable drug delivery platforms of the plurality of bioresorbable drug delivery platforms comprising a polymer scaffold of from about 40% to about 60% of the drug delivery platform by mass and a therapeutic agent contained within the polymer scaffold of from about 40% to about 60% of the drug delivery platform by mass, wherein a sum of the percentage by mass of the polymer scaffold and the percentage by mass of the therapeutic agent is equal to or less than 100%;

allowing the therapeutic agent to elute from each of the bioresorbable drug delivery platforms of the plurality of bioresorbable drug delivery platforms over a sustained period of time; and

allowing each of the bioresorbable drug delivery platforms of the plurality of bioresorbable drug delivery platforms to biodegrade within the target tissue,

wherein each of the bioresorbable drug delivery platforms of the plurality of bioresorbable drug delivery platforms is configured in size and mechanical integrity to pass through the needle for implantation submucosally into the target tissue, and such that the sustained period of time is from about 6 months to about 9 months,

wherein each of the bioresorbable drug delivery platforms of the plurality of bioresorbable drug delivery platforms has a biased distribution of the therapeutic agent radially out from a center of each of the bioresorbable drug delivery platforms of the plurality of bioresorbable drug delivery platforms.

2. The method of claim 1 , wherein the condition is a sinus related condition.

3. The method of claim 1 , wherein the condition is an otic related condition.

4. The method of claim 1 , wherein the condition is a throat related condition.

5. The method of claim 1 , wherein the polymer scaffold of each of the bioresorbable drug delivery platforms of the plurality of bioresorbable drug delivery platforms comprises a core region and a main body, and further wherein the core region of each of the bioresorbable drug delivery platforms of the plurality of bioresorbable drug delivery platforms comprises a formulation of polymer material and the therapeutic agent that is different than a formulation of the main body.

6. The method of claim 1 , wherein a core region of each of the bioresorbable drug delivery platforms of the plurality of bioresorbable drug delivery platforms comprises a hollow channel, and wherein the hollow channel of the core region of each of the bioresorbable drug delivery platforms of the plurality of bioresorbable drug delivery platforms is configured to hold a volume of the therapeutic agent.

7. The method of claim 1 , wherein the therapeutic agent of each of the bioresorbable drug delivery platforms of the plurality of bioresorbable drug delivery platforms comprises a steroidal anti-inflammatory agent selected from the group consisting of mometasone furoate, fluticasone propionate, and dexamethasone.

8. The method of claim 1 , wherein the polymer scaffold of each of the bioresorbable drug delivery platforms of the plurality of bioresorbable drug delivery platforms comprises a polymer material that is ester end capped, acid end capped, or a combination thereof.

9. The method of claim 8 , wherein the polymer material of each of the bioresorbable drug delivery platforms of the plurality of bioresorbable drug delivery platforms comprises poly(D,L-lactide-co-glycolide), and wherein a molar ratio of the poly(D,L-lactide-co-glycolide) ranges from 0% to 100% lactide and from 0% to 100% glycolide.

10. A method for treating symptoms of a condition, the method comprising:

inserting a distal tip of a needle submucosally into a target tissue;

delivering a plurality of bioresorbable drug delivery platforms from the needle into the target tissue, each of the bioresorbable drug delivery platforms of the plurality of bioresorbable drug delivery platforms comprising an active agent of from about 40% to about 60% of the drug delivery platform by mass and contained within a polymer scaffold of from about 40% to about 60% of the drug delivery platform by mass, wherein a sum of the percentage by mass of the polymer scaffold and the percentage by mass of the active agent is equal to or less than 100%;

allowing a dose of the active agent to be released from each of the bioresorbable drug delivery platforms of the plurality of bioresorbable drug delivery platforms over a sustained period of time, wherein the release from each of the bioresorbable drug delivery platforms of the plurality of bioresorbable drug delivery platforms over the sustained period of time provides a therapeutically effective amount of the active agent in the target tissue; and

allowing each of the bioresorbable drug delivery platforms of the plurality of bioresorbable drug delivery platforms to biodegrade within the target tissue,

wherein each of the bioresorbable drug delivery platforms of the plurality of bioresorbable drug delivery platforms is configured in size and mechanical integrity to pass through the needle for implantation submucosally into the target tissue, and such that the sustained period of time is from about 6 months to about 9 months,

wherein each of the bioresorbable drug delivery platforms of the plurality of bioresorbable drug delivery platforms has a biased distribution of the active agent radially out from a center of each of the bioresorbable drug delivery platforms of the plurality of bioresorbable drug delivery platforms.

11. The method of claim 10 , wherein the delivering comprises injecting the plurality of bioresorbable drug delivery platforms from the needle into the target tissue.

12. The method of claim 11 , wherein the plurality of bioresorbable drug delivery platforms is injected from the needle using a revolver loading structure or a magazine loading structure.

13. The method of claim 10 , wherein the dose of the active agent of each of the bioresorbable drug delivery platforms of the plurality of bioresorbable drug delivery platforms is between about 400 μg and about 1350 μg.

14. The method of claim 10 , wherein at least 25% of the dose of the active agent is released from each of the bioresorbable drug delivery platforms of the plurality of bioresorbable drug delivery platforms after 7 days.

15. The method of claim 10 , wherein at least 50% of the dose of the active agent is released from each of the bioresorbable drug delivery platforms of the plurality of bioresorbable drug delivery platforms after 30 days.

16. The method of claim 10 , wherein at least 70% of the dose of the active agent is released from each of the bioresorbable drug delivery platforms of the plurality of bioresorbable drug delivery platforms after 90 days.

17. The method of claim 10 , wherein releasing the active agent of each of the bioresorbable drug delivery platforms of the plurality of bioresorbable drug delivery platforms over 7 days provides the therapeutically effective amount of the active agent in the target tissue of at least 0.1 μg/g.

18. The method of claim 10 , wherein releasing the active agent of each of the bioresorbable drug delivery platforms of the plurality of bioresorbable drug delivery platforms over 7 days provides the therapeutically effective amount of the active agent in the target tissue of at least 0.2 μg/g.

19. The method of claim 10 , wherein releasing the active agent of each of the bioresorbable drug delivery platforms of the plurality of bioresorbable drug delivery platforms over 30 days provides the therapeutically effective amount of the active agent in the target tissue of at least 122 μg/g.

20. The method of claim 10 , wherein releasing the active agent of each of the bioresorbable drug delivery platforms of the plurality of bioresorbable drug delivery platforms over 90 days provides the therapeutically effective amount of the active agent in the target tissue of at least 417 μg/g.

21. The method of claim 10 , wherein the release from each of the bioresorbable drug delivery platforms of the plurality of bioresorbable drug delivery platforms over the sustained period of time further provides a therapeutically effective amount of the active agent in a tissue adjacent the target tissue.

22. The method of claim 10 , wherein the active agent of each of the bioresorbable drug delivery platforms of the plurality of bioresorbable drug delivery platforms comprises a steroidal anti-inflammatory agent selected from the group consisting of mometasone furoate, fluticasone propionate, dexamethasone, and combinations thereof.

23. The method of claim 10 , wherein the target tissue is a paranasal sinus, a sinus ostium, an inferior turbinate, a middle turbinate, a superior turbinate, a nasal cavity, a nasal vestibule, a nasal septum, nasal polypoid tissues, an osteomeatal complex, a nasopharynx, an adenoid tissue, or a combination thereof.

24. The method of claim 10 , wherein the delivering includes using a speed focused approach.

25. The method of claim 10 , the delivering includes a hemostatic control focused approach.

26. The method of claim 10 , wherein the delivering reduces systemic exposure of the active agent.

Assignments (2)
ASSIGNMENT OF ASSIGNOR'S INTEREST Recorded Oct 18, 2023
From: BITLA, RAHUL
To: INTERSECT ENT, INC.
Reel/Frame 065261/0246 →
ASSIGNMENT OF ASSIGNOR'S INTEREST Recorded Mar 9, 2021
From: STANKUS, JOHN JOSEPH; SU, JAMES; ABBATE, ANTHONY J.; NGO, TU DUC; GARNICA, DIEGO JAVIER
To: INTERSECT ENT, INC.
Reel/Frame 055532/0417 →
Continuity (2)
Provisional Application 62894113 · Aug 30, 2019
Related Publication 20210060316A1 · Mar 4, 2021
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