(19) TZZ ¥ _T (11) EP 2 234 652 B1 (12) EUROPEAN PATENT SPECIFICATION (45) Date of publication and mention (51) Int Cl.: of the grant of the patent: A61L 15/44 (2006.01) A61L 15/42 (2006.01) 24.09.2014 Bulletin 2014/39 A61L 15/58 (2006.01) A61L 15/64 (2006.01) A61L 26/00 (2006.01) (21) Application number: 08870494.5 (86) International application number: (22) Date of filing: 22.12.2008 PCT/US2008/087920 (87) International publication number: WO 2009/088726 (16.07.2009 Gazette 2009/29) (54) MUCOSAL TISSUE DRESSING AND METHOD OF USE SCHLEIMHAUTGEWEBEAUFLAGE UND VERFAHREN ZU IHRER VERWENDUNG PANSEMENT DE TISSU MUCOSAL ET SON PROCÉDÉ D’UTILISATION (84) Designated Contracting States: • MUNI, Ketan, P. AT BE BG CH CY CZ DE DK EE ES FI FR GB GR San Jose, CA 95123 (US) HR HU IE IS IT LI LT LU LV MC MT NL NO PL PT • CARLYLE, Wenda RO SE SI SK TR Newton, CT 06470 (US) • LEVINE, Howard (30) Priority: 31.12.2007 US 17976 Lyndhurst, OH 44124 (US) 12.05.2008 US 52413 • FACTEAU, William, M. Mountain View, CA 94041 (US) (43) Date of publication of application: 06.10.2010 Bulletin 2010/40 (74) Representative: Tunstall, Christopher Stephen et al (73) Proprietor: Acclarent, Inc. Carpmaels & Ransford LLP Menlo Park, CA 94025 (US) One Southampton Row London WC1B 5HA (GB) (72) Inventors: • MAKOWER, Joshua (56) References cited: Los Altos, CA 94022 (US) WO-A2-2005/027852 US-A- 5 137 729 • CHANG, John, Y. US-A- 5 456 745 US-A- 5 882 324 Mountain View, CA 94022 (US) US-A- 6 051 249 US-A1- 2005 048 102 Note: Within nine months of the publication of the mention of the grant of the European patent in the European Patent Bulletin, any person may give notice to the European Patent Office of opposition to that patent, in accordance with the Implementing Regulations. Notice of opposition shall not be deemed to have been filed until the opposition fee has been paid. (Art. 99(1) European Patent Convention). EP 2 234 652 B1 Printed by Jouve, 75001 PARIS (FR) EP 2 234 652 B1 Description BACKGROUND OF THE INVENTION 5 [0001] Tonsillectomy and adenoidectomy are two of the most common surgical procedures performed on children. Both tonsillectomy and adenoidectomy are associated with considerable post-operative pain that may often last as long as two weeks. Due to this post-operative pain, which is most severe when trying to swallow food, children typically cannot eat solid food for at least two days after surgery and often for as long as six days after surgery. In addition to post- operative pain, children also commonly suffer from post-operative bleeding, nausea, and/or bad breath after tonsillec- 10 tomy/adenoidectomy. Although tonsillectomy and adenoidectomy are performed less commonly on adults, the proce- dures cause similar post-surgical pain and discomfort in adult patients. [0002] Generally, surgical procedures on mucosal tissue, such as tonsillectomy and adenoidectomy, present several post-operative challenges. Mucosal tissue is typically very delicate and difficult to bandage. Mucosal tissue often must stay wet to heal and to perform its intended function. Damaged mucosal tissue can produce significant patient discomfort. 15 [0003] A number of tonsillectomy/adenoidectomy procedures have been developed in an attempt to reduce the post- operative pain and discomfort caused by the procedure. For example, the Coblation Tonsillectomy procedure developed by Arthrocare Corporation (Austin, Texas) was developed as a "less invasive" an thus less painful, tonsillectomy method. However, even using the Coblation Tonsillectomy procedure or other less invasive procedures, post-operative pain and bleeding are still significant for many children and adult patients, often preventing them from eating food for days after 20 their surgeries. To date, no satisfactory post-operative treatments have been developed to alleviate this pain and to allow patients to comfortably eat after tonsillectomy and adenoidectomy procedures. [0004] Therefore, a need exists for a post-surgical treatment that would help children and adult patients recover from tonsillectomy and adenoidectomy. Ideally, such a treatment would act as a barrier to protect mucosal tissue at and around the surgical site to make it easier and less painful for a patient to swallow. Ideally, the barrier would adhere to 25 mucosal tissue even with the abrasive forces of swallowing and, in addition to reducing pain, would also reduce bleeding. At least some of these objectives will be met by various embodiments of the present invention. [0005] In addition to post-tonsillectomy/adenoidectomy treatment, there are many other treatments in the ear, nose, throat or mouth that could be performed or enhanced with a mucosal tissue dressing. For example, it would be desirable to have a mucosal tissue dressing that could adhere to tissue and deliver one or more therapeutic substances to a 30 desired area in the ear, nose, throat or mouth. It would also be beneficial to have a dressing for stopping a cerebrospinal fluid leak, reducing blood loss from an incision, acting as a bolster or support to a piece of tissue and/or the like. In any of these contexts, the challenges of providing a mucosal tissue dressing are similar, in that the dressing must stay in place long enough, perform its function, and not interfere with normal physiological function. Various embodiments of the present invention will also meet at least some of these objectives for purposes other than a post-tonsillectomy/ad- 35 enoidectomy dressing. [0006] WO-A-2005027852 describes compositions containing various bioabsorbable polymers for preventing post- surgical adhesions. [0007] US-A-20050048102describes pharmaceutical deliverydevices fordelivering activeagents to mucosal surfaces. The delivery devices comprise an adhesive layer and a non-adhesive backing layer. One or both of the layers may 40 contain the active agents. [0008] US-A-5456745 describes polymer blends for forming a flexible, hydrophilic, water-swellable but insoluble gel film for use in various medical applications. [0009] US-A-5137729 describes describes soft, adhesive film compositions for sustained delivery of active agents to mucosal surfaces. 45 BRIEF SUMMARY OF THE INVENTION [0010] The present invention provides a product comprising: an adhesive material; and a barrier material, for simul- taneous or sequential post-surgical application to mucosal tissue to provide a multilayer film dressing comprising a layer 50 of said barrier material and a layer of said adhesive material contacting the barrier material and the mucosal tissue, wherein the barrier material and the adhesive material remain substantially intact for a period of time from 48 hours to 14 days after applying the multilayer film to the mucosal tissue, wherein the barrier material, adhesive material, or both comprise a cellulose, modified cellulose, or combinations thereof, said multilayer film dressing having an outer rim and a concave central region. 55 [0011] Certain embodiments of the present invention provide a biodegradable film or covering that serves as a me- chanical barrier to reduce pain caused, for example, by friction between solid food and healing tissue in the first few days after surgery. [0012] Some embodiments may include one or more therapeutic substances for locally reducing pain, facilitating 2 EP 2 234 652 B1 healing and/or otherwise treating mucosal tissue at or near a tonsil bed. In some embodiments, multiple layers of tissue dressing may contain different therapeutic substances. Some embodiments may allow a physician to inject or otherwise apply one or more therapeutic substances to a tissue dressing before applying the dressing to the patient. [0013] In some embodiments, a tissue dressing may be applied to areas other than a tonsil bed and for purposes 5 other than easing post-tonsillectomy pain and discomfort. For example, in some embodiments, a tissue dressing may be applied to a nasal septum to facilitate or enhance a nasal septoplasty procedure. In various embodiments, a tissue dressing may be applied at any of a number of locations in a nasal or paranasal cavity, in paranasal sinuses, in polyps located in the nasal or paranasal cavity, in a Eustachian tube, in a mouth or the like, for performing any number of functions. For example, the tissue dressing may be placed as a therapeutic drug delivery vehicle. In some embodiments, 10 the tissue dressing may be used to stiffen or fortify soft tissues, such as for treating sleep apnea. In other embodiments, the tissue dressing may be used to cover or plug up cerebrospinal fluid (CSF) leaks. In still other embodiments, a tissue dressing may be used as an iontophoresis pad through which electrical energy may be passed. These and other em- bodiments are described further below with reference to the attached drawings. 15 BRIEF DESCRIPTION OF SEVERAL VIEWS OF THE DRAWINGS [0014] Figure 1 illustrates a perspective view of a reference dressing. 20 Figure 2 illustrates a perspective view of a two layer reference dressing. Figure 3 illustrates a perspective view of a multilayer layer reference dressing. 25 Figure 4 illustrates a perspective view of a tissue dressing, according to one embodiment of the present invention. Figure 5 illustrates a perspective view of a cylinder-shaped reference tissue dressing, such as for use in or near a Eustachian tube 30 Figure 6 illustrates a method of preparing a reference dressing for use. Figure 7 illustrates a method of packaging and preparing a multi-layer reference dressing for use. Figures 8A and 8B illustrate methods of packaging a reference dressing for use. 35 Figure 9 illustrates a method of packaging a reference dressing for use. Figure 10 illustrates a device and method useful in applying an in-situ dressing, according to one embodiment of the present invention. 40 Figure 11A illustrates a device and method useful in applying an in-situ dressing and Figure 11B illustrates a close- up view of a section of the same device and method, according to one embodiment of the present invention.