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WO 2010/126912 Al (12) INTERNATIONAL APPLICATION PUBLISHED UNDER THE PATENT COOPERATION TREATY (PCT) (19) World Intellectual Property Organization International Bureau (10) International Publication Number (43) International Publication Date 4 November 2010 (04.11.2010) WO 2010/126912 Al (51) International Patent Classification: Paseo Del Cajon, Pleasanton, CA 94566 (US). EARN¬ A61B 17/26 (2006.01) HARDT, Lisa [US/US]; 2006 Sand Hill Road, Menlo Park, CA 94025 (US). RAJASEKHAR, Vijaykumar (21) International Application Number: [US/US]; 20200 Quail Hollow Road, Apple Valley, CA PCT/US20 10/032630 92308 (US). (22) International Filing Date: (74) Agents: REESLUND, Marcus et al; Morrison & Foer- 27 April 2010 (27.04.2010) ster LLP, 755 Page Mill Road, Palo Alto, CA 94304-1018 (25) Filing Language: English (US). (26) Publication Language: English (81) Designated States (unless otherwise indicated, for every kind of national protection available): AE, AG, AL, AM, (30) Priority Data: AO, AT, AU, AZ, BA, BB, BG, BH, BR, BW, BY, BZ, 61/173,093 27 April 2009 (27.04.2009) US CA, CH, CL, CN, CO, CR, CU, CZ, DE, DK, DM, DO, (71) Applicant (for all designated States except US): INTER¬ DZ, EC, EE, EG, ES, FI, GB, GD, GE, GH, GM, GT, SECT ENT, INC. [US/US]; 1049 Elwell Court, Palo HN, HR, HU, ID, IL, IN, IS, JP, KE, KG, KM, KN, KP, Alto, CA 94303 (US). KR, KZ, LA, LC, LK, LR, LS, LT, LU, LY, MA, MD, ME, MG, MK, MN, MW, MX, MY, MZ, NA, NG, NI, (72) Inventors; and NO, NZ, OM, PE, PG, PH, PL, PT, RO, RS, RU, SC, SD, (75) Inventors/Applicants (for US only): HESTER, Jerome, SE, SG, SK, SL, SM, ST, SV, SY, TH, TJ, TM, TN, TR, E. [US/US]; 9 Helen Place, Menlo Park, CA 94025 (US). TT, TZ, UA, UG, US, UZ, VC, VN, ZA, ZM, ZW. ABBATE, Anthony, J . [US/US]; 4346 Headen Way, Santa Clara, CA 95054-4171 (US). KAUFMAN, (84) Designated States (unless otherwise indicated, for every Richard, E. [US/US]; 80 Old Orchard Road, Los Gatos, kind of regional protection available): ARIPO (BW, GH, CA 95033 (US). GALE, David, C. [US/US]; 2100 GM, KE, LR, LS, MW, MZ, NA, SD, SL, SZ, TZ, UG, Shiloh Valley Drive, Apt. 5023, Kennesaw, GA 30144 ZM, ZW), Eurasian (AM, AZ, BY, KG, KZ, MD, RU, TJ, (US). ZALER, Gail, M . [US/US]; 27 Jacklin Circle, Mil- TM), European (AT, BE, BG, CH, CY, CZ, DE, DK, EE, ES, FI, FR, GB, GR, HR, HU, IE, IS, IT, LT, LU, LV, pitas, CA 95035 (US). HUANG, Bin [US/US]; 1996 MC, MK, MT, NL, NO, PL, PT, RO, SE, SI, SK, SM, [Continued on next page] (54) Title: DEVICES AND METHODS FOR TREATING PAIN ASSOCIATED WITH TONSILLECTOMIES (57) Abstract: Described here are devices and methods for treating one or more conditions or symptoms associ ated with a tonsil procedure. In some variations, a drug- releasing device may be at least partially delivered to one or more tonsillar tissues before, during, or after a tonsil procedure. In some variations, the drug-releasing device may be configured to be biodegradable. In other variations, the drug-releasing device may comprise one or more hemostatic materials or one or more adhesives. The drug-releasing device may be configured to release one or more drugs or agents, such as, for example, one or more analgesics, local anesthetics, vasoconstrictors, antibiotics, combinations thereof and the like. TR), OAPI (BF, BJ, CF, CG, CI, CM, GA, GN, GQ, GW, Published: ML, MR, NE, SN, TD, TG). , , , . , — with internattional search reportt (Art. 21(/3)j DEVICES AND METHODS FOR TREATING PAIN ASSOCIATED WITH TONSILLECTOMIES CROSS-REFERENCE TO RELATED APPLICATIONS [0001] This application claims priority to U.S. Provisional Patent Application Serial No. 61/173,093, filed on April 27, 2009 and titled "DEVICES AND METHODS FOR TREATING PAIN ASSOCIATED WITH TONSILLECTOMIES," which is incorporated by reference herein in its entirety. FIELD [0002] The present invention relates generally to devices and methods for the treatment of one or more tonsils, adenoids, and/or surrounding tissue. BACKGROUND [0003] One of the oldest known surgical procedures, a tonsillectomy is an operation during which one or more portions of the palatine tonsils ("tonsils") are removed. An adenoidectomy is a procedure during which one or more portions of the pharyngeal tonsils ("adenoids") are removed. Tonsillectomies and adenoidectomies are usually performed to alleviate one or more symptoms that may be associated with infected or enlarged tonsils or adenoids, such as chronic sore throats, recurring strep throat, abscesses, upper airway obstructions, ear infections, bad breath, and sleep apnea. Tissue may be removed in one of many ways, such as cold dissection, electrocautery removal, laser removal, coblation, microdebriding, radiofrequency ablation, and harmonic scalpel dissection. [0004] Tonsillectomies and adenoidectomies are very common, with over 800,000 procedures being performed each year in the United States. Despite the frequency of these procedures, as well as the varied means by which they are performed, tonsillectomies and adenoidectomies are still associated with a great deal of post-operative pain and discomfort. More specifically, there is usually a seven- to ten-day recovery period during which a patient may experience pain, discomfort, dehydration and weight loss. Additionally, there is an approximately 1-7% rate of post-operative hemorrhaging, as well as a risk of infection. [0005] Little has been done to successfully reduce the pain or discomfort following a tonsillectomy or adenoidectomy. Generally, a physician will prescribe antibiotics and narcotics (e.g., acetaminophen, codeine) for post-operative pain. Oral administration of such antibiotics and narcotics may be undesirable, as swallowing may be extremely painful for a patient. Additionally, the amount of narcotic ingested may yield other undesirable side effects, such as drowsiness, dizziness, light-headedness, or other complications that result from the exposure of the entire body to the effects of the narcotic. Other post-operative treatment methods, including topical, intravenous, intralesional and oral administration of narcotics, non-steroidal ant-inflammatory drugs (NSAIDS), steroids, and/or local anesthetics have been minimally effective at reducing pain or discomfort. As such, it would be desirable to provide a more effective way of reducing pain or discomfort following a tonsil procedure (e.g., a tonsillectomy, adenoidectomy, or the like). BRIEF SUMMARY [0006] Described here are devices and methods for treating the tonsils, adenoids, and/or surrounding tissue. Generally, one or more devices are attached to or implanted in or around tissue, and may be configured to release one or more drugs to the tonsil or adenoids. In some variations, the devices are used to treat an inflamed or enlarged tonsil or adenoids. In other variations, the devices are used to aid in post-operative recovery following a tonsillectomy or adenoidectomy (e.g., by locally delivering one or more drugs, by covering or manipulating exposed tissue, etc.). [0007] In some variations, one or more sutures or suture-like materials may be at least partially implanted in tonsillar tissue. In some of these variations, the one or more sutures are configured to release one or more drugs to the tonsils. In other variations, the suture is configured to self-anchor within tissue (e.g., the suture may comprise one or more unidirectional elements that allow suture to be pulled through tissue in a first direction, but resist movement in an opposite direction). In still other variations, the suture is biodegradable. [0008] In other variations, one or more tissue-piercing devices may implanted into, around, or adjacent to tonsillar tissue. Generally the tissue-piercing devices are designed to pierce, puncture, or otherwise penetrate tissue. In some of these variations, the tissue-piercing devices comprise one or more filaments, spikes, or staples. In some variations, the tissue-piercing devices are configured to resist removal from tissue. In some of these variations, the tissue-piercing devices comprise one or more barbs, prongs, notches, threading, or a combination thereof. [0009] In still other variations, one or more clips may be attached to tonsillar tissue. Generally the clips may comprise a surface member and one or more anchoring members. In some of these variations, the surface member and anchoring members may be formed from a single piece of material. In other variations, one or more sutures or tissue- piercing devices may be used to attach the surface member to tissue. [0010] In other variations, one or more tissue-restraining devices may be applied to tonsillar tissue. In some of these variations, the tissue-restraining device may be configured to stretch an area of tissue. In other variations, the tissue-restraining device may be configured to help prevent movement of one or more tissues. The tissue-restraining device may comprise a body member, and may additionally comprise one or more anchors. Anchors may be used to attach the tissue-restraining device to tissue, and may have any suitable configuration of elements, as described in more detail below. [0011] In some variations, a plurality of space-filling implants may be used to fill one or more spaces within tonsillar tissue. The space-filling implants may comprise one or more beads, pellets, seeds, capsules, or a combination thereof. The space-filling implants may self-assemble to conform to the shape of one or more spaces within tonsillar tissue. In some variations, one or more space-filling implants may be configured to burst upon application of one or more forces or stimuli thereto. BRIEF DESCRIPTION OF THE DRAWINGS [0012] FIGS. IA- 1C are illustrations of the tonsils, adenoids, and their surrounding anatomy. [0013] FIGS. 2A-2K depict illustrative variations of tissue-piercing devices. [0014] FIG. 3 depicts a variation of a filament comprising notches. [0015] FIGS.
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