Resorbable, drug-eluting submucosal turbinate implant device and method

• US 10,596,330 B2
• Filed: 08/26/2015
• Issued: 03/24/2020
• Est. Priority Date: 08/26/2015
• Status: Active Grant

• Current Assignee: Medtronic Xomed Incorporated (Medtronic Plc)
• Original Assignee: Medtronic Xomed Incorporated (Medtronic Plc)
• Inventors: Medina, Jennifer G., Amery, Drew P., Oliver, Dana A., Wen, Jie
• Primary Examiner(s): Lee, Brandy S
• Application Number:
  US14/836,594
• Publication Number:
  US 20170056602A1
• Time in Patent Office: 1,672 Days
• 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 17/3468 for implanting or removing devices, e.g. prostheses, implants, seeds, wires devices for implanting seeds A61M37/0069
• CPC Class Codes: A61K 9/0024 Solid, semi-solid or solidifying implants, which are implanted or injected in body tissue compositions for intravenous administration, normal injectable solutions or dispersions for, e.g. subcutaneous administration A61K9/0019; brain implants A61K9/0085; (coated) prostheses, catheters or stents A61L
• CPC Class Codes: A61L 31/16 Biologically active materials, e.g. therapeutic substances A61L31/047 takes precedence
• CPC Class Codes: A61M 2205/04 implanted
• CPC Class Codes: A61M 2210/0681 Sinus (maxillaris)
• CPC Class Codes: A61M 5/3286 Needle tip design, e.g. for improved penetration
• CPC Class Codes: A61M 5/3287 Accessories for bringing the needle into the body; Automatic needle insertion A61M5/20, A61M5/31525 take precedence

Abstract

Implants are placed in turbinate mucosal tissue using a surgical device having a proximal grip portion and a distal hollow sharp needle portion that is manipulated using the grip portion and inserted submucosally into mucosal turbinate tissue. One or more biodegradable, drug-eluting solid implants are disposed within the needle. The implants have one or more implant withdrawal-discouraging, mucosal tissue-engaging surface features along their length. An actuator disposed within the device is used to deliver one or more of the implants from the needle into the mucosal turbinate tissue and submucosally bury at least one such tissue-engaging feature therein.

Claims

1. A surgical device comprising:

(a) a proximal grip portion configured to be grasped outside a patient;

(b) a distal hollow sharp needle portion configured to be manipulated using the grip portion and inserted submucosally into mucosal turbinate tissue in the patient;

(c) one or more biodegradable, drug-eluting solid implants disposed within the hollow needle portion, the implants having a length along the hollow needle portion, and one or more implant withdrawal-discouraging, mucosal tissue-engaging surface features along the length; and

(d) an actuator disposed within the device and configured to deliver one or more of the implants from the hollow needle portion into the mucosal turbinate tissue and submucosally bury at least one of the implant withdrawal-discouraging, mucosal tissue-engaging surface features therein.

2. A device according to claim 1 wherein the device contains two or more implants.

3. A device according to claim 1 wherein the device has one or more tabs and openings that provide visible, audible or tactile feedback of the progress of an implant or implants through the needle portion.

4. A device according to claim 1 wherein the device has one or more latches that prevent removal of the actuator.

5. A device according to claim 1 wherein the needle portion is bent.

6. A device according to claim 1 wherein the device is sealed in sterile packaging.

7. A device according to claim 1 wherein the implant comprises a polymeric matrix with a drug impregnated or dispersed therein or coated thereon.

8. A device according to claim 1 wherein the implant degrades in less than one month in mucosal turbinate tissue.

9. A device according to claim 1 wherein the drug elutes from the implant for at least three days and for less than one month.

10. A device according to claim 1 wherein the drug comprises an angiotensin convertin enzyme (ACE) inhibitor;

angiotensin receptor blocker (ARBS);

antihistamine;

steroidal or non-steroidal anti-inflammatory agent;

chymase inhibitor;

cyclooxygenase-2 (COX-2) inhibitor;

decongestant;

matrix metalloproteinase (MMP) inhibitor;

mucolytic;

therapeutic polymer or combination thereof.

11. A device according to claim 1 wherein the drug comprises doxycycline, TIMP metallopeptidase inhibitor 1 or dexamethasone.

12. A device according to claim 1 wherein the one or more implant withdrawal-discouraging, mucosal tissue-engaging surface features include projections.

13. A device according to claim 12 wherein the projections comprise bumps, ribs, hooks or a ratchet rack.

14. A device according to claim 1 wherein the one or more implant withdrawal-discouraging, mucosal tissue-engaging surface features include recesses.

15. A device according to claim 14 wherein the recesses comprise dimples, grooves or porosity.

16. A device according to claim 1 wherein the one or more implant withdrawal-discouraging, mucosal tissue-engaging surface features include a braided structure.

17. A device according to claim 1 wherein one or more implant withdrawal-discouraging, mucosal tissue-engaging surface features are swellable upon exposure to fluid.

18. A device according to claim 1 wherein the implant is not tensioned after implantation.

19. A device according to claim 1 wherein the implant does not draw tissue together after implantation.

20. A device according to claim 1 wherein the implant does not contact bone after implantation.

21. A device according to claim 1 wherein the work, expressed as a product of force times distance, required to bury the implant submucosally in the mucosal turbinate tissue is less than the work required to remove the buried implant from the mucosal turbinate tissue.

22. A device according to claim 1 wherein the maximum force required to bury the implant submucosally in the mucosal turbinate tissue is less than the maximum force required to remove the buried implant from the mucosal turbinate tissue.

23. A method for sinus treatment, the method comprising:

(a) providing a surgical device comprising;

(i) a proximal grip portion configured to be grasped outside a patient;

(ii) a distal hollow sharp needle portion configured to be manipulated using the grip portion and inserted submucosally into mucosal turbinate tissue in the patient;

(iii) one or more biodegradable, drug-eluting solid implants disposed within the hollow needle portion, the implants having a length along the hollow needle portion, and one or more implant withdrawal-discouraging, mucosal tissue-engaging surface features along the length; and

(iv) an actuator disposed within the device and configured to deliver one or more of the implants from the hollow needle portion into the mucosal turbinate tissue and submucosally bury at least one of the implant withdrawal-discouraging, mucosal tissue-engaging surface features therein;

(b) manipulating the grip portion to pierce the mucosal turbinate tissue and submucosally insert the hollow needle portion therein, and

(c) activating the actuator to deliver one or more of the implants from the hollow needle portion into the mucosal turbinate tissue and submucosally bury at least one such tissue-engaging feature within the mucosal turbinate tissue.