(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 WO 2016/084087 A3
2 June 2016 (02.06.2016) P O PCT

(51) International Patent Classification: (81) Designated States (unless otherwise indicated, for every
A61F 2/18 (2006.01) A61F 2/82 (201 3.01) kind of national protection available): AE, AG, AL, AM,
A61F 2/02 (2006.01) AO, AT, AU, AZ, BA, BB, BG, BH, BN, BR, BW, BY,
BZ, CA, CH, CL, CN, CO, CR, CU, CZ, DE, DK, DM,
(21) International Application Number:
DO, DZ, EC, EE, EG, ES, FI, GB, GD, GE, GH, GM, GT,
PCT/IL20 15/05 1 153
HN, HR, HU, ID, IL, IN, IR, IS, JP, KE, KG, KN, KP, KR,
(22) International Filing Date: KZ, LA, LC, LK, LR, LS, LU, LY, MA, MD, ME, MG,
26 November 2015 (26.1 1.2015) MK, MN, MW, MX, MY, MZ, NA, NG, NI, NO, NZ, OM,
PA, PE, PG, PH, PL, PT, QA, RO, RS, RU, RW, SA, SC,
(25) Filing Language: English SD, SE, SG, SK, SL, SM, ST, SV, SY, TH, TJ, TM, TN,
(26) Publication Language: English TR, TT, TZ, UA, UG, US, UZ, VC, VN, ZA, ZM, ZW.

(30) Priority Data:
62/084,83 1 26 November 2014 (26. 11.2014) US
(71) Applicant: S.T.S. MEDICAL LTD. [IL/IL]; 17 Tchelet
Street, Misgav Business Park, 2017400 Doar-Na Misgav
(EL).
(72) Inventors: YANIV, Eitan; 64 Ben-Gurion Street, 4500966
Hod-HaSharon (IL). HAR-EL, Gady; 193-38 Keno Aven
ue, Hollis, New York 1 1423 (US). FRENKLACH,
Gregory; 23/1 Nahal Zohar Street, 7170478 Modiln (IL). Declarations under Rule 4.17 :
FLOMENBLIT, Joseph; 16/9 Zikhron Yaakov Street,
4972806 Petach-Tikva (IL). SHLOSSBERG, Lena; 17/34
Yael Rom Street, 4906203 Petach-Tikva (IL).
(74) Agents: EHRLICH, Gal et al; G.E. Ehrlich (1995) LTD.,
11 Menachem Begin Road, 5268104 Ramat Gan (IL).
(84) Designated States (unless otherwise indicated, for every
kind of regional protection available): ARIPO (BW, GH,
GM, KE, LR, LS, MW, MZ, NA, RW, SD, SL, ST, SZ,
TZ, UG, ZM, ZW), Eurasian (AM, AZ, BY, KG, KZ, RU,
TJ, TM), European (AL, AT, BE, BG, CH, CY, CZ, DE,
DK, EE, ES, FI, FR, GB, GR, HR, HU, IE, IS, IT, LT, LU,
LV, MC, MK, MT, NL, NO, PL, PT, RO, RS, SE, SI, SK,
SM, TR), OAPI (BF, BJ, CF, CG, CI, CM, GA, GN, GQ,
GW, KM, ML, MR, NE, SN, TD, TG).
— of inventorship (Rule 4. 1 7(iv))
Published:
— with international search report (Art. 21(3))

[Continued on next page]

(54) Title: SHAPE CHANGE STRUCTURE FOR TREATMENT OF NASAL CONDITIONS INCLUDING SINUSITIS
(57) Abstract: A method of treatment of nasal
conditions comprising: delivering an expandable
structure in a crimped configuration to a nasal lu
men; expanding the expandable structure within
the nasal lumen to a stable expanded configura
tion; removing the structure from the nasal lu
men, after a time period, where removing com
prises causing the structure to self-crimp. The ex
pandable structure optionally comprises: a first
shape memory (SM) portion which is in a strain-
induced state; and a second portion which resists
expansion of said structure due to said first por
tion, over a plurality of different expansion states
of said first portion. Optionally, the properties of
the second portion vary over its cross section. For
example an outer surface and/or peripheral layer
may have desirable environmental resistance
properties and /or a frame may have desirable
< mechanical properties, for example a high creep
resistance.
0 FIG. 20
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 w o 2016/084087 A3 1I 11 II I 1 I lllll I III I II III I lllll III II

before the expiration of the time limit for amending the e P ' Internat i ona s r
claims and to be republished in the event of receipt of
amendments (Rule 48.2(h))
 INTERNATIONAL SEARCH REPORT International application No.

PCT/IL1 5/51 153

A. CLASSIFICATION O F SUBJECT MATTER

IPC(8) - A61F2/18, A61 F 2/02. A61 F2/82 (2016.01 )
CPC - A61F2/18, A61 F2/186, A61 F2/82
According to International Patent Classification (IPC) or to both national classification a d IPC

B. FIELDS SEARCHED

Minimum documentation searched (classification system followed by classification symbols)

IPC(8): A61 F2/00, A61 F2/02, A61 F2/04, A61F2/18, A61F2/844, A61F2/82, A61 F2/86 (2016.01); CPC: A61F2/18, A61 F2/186, A61F2/82,
A61F2/844, A61F2/86, A61 F2/915, A61 F2250/0014 A61F2250/0042, A61 F2210/0023, C22F1/006, A61F221 0/0042, A61 F2/04

Documentation searched other than minimum documentation to the extent that such documents are included in the fields searched

Electronic data base consulted during the international search (name of data base and, where practicable, search terms used)
PatSeer (US, EP, WO, JP, DE, GB, CN, F , KR, ES, AU, IN, CA, INPADOC Data); PubMed; EBSCO; Google/Google Scholar;
KEYWORDS: stent, sturcture, scaffold, nasal, nose, nostril, sinus, self_crimp*, self_remov*, crimp, compress, releas*, contract*,
shape_memory, cavity, septum, radial, force, crush*, creep, resist*, temperature, balloon, creep*, environment*, durab*, polymer*

C. DOCUMENTS CONSIDERED T O B E RELEVANT

Category* Citation o f document, with indication, he e appropriate, o f the relevant passages Relevant to claim No.

X US 2009/00369 Θ8 A 1 (HEPWORTH, E et al.) b February 2009; figures 2 , 4-5; paragraphs 27, 32-33, 39
30 3 1 , 36, 07-00, Λ2 , 51, 5 , 0 5
Y 34- 38, 40-42

X U S 2014/0296957 A 1 (COOK MEDICAL TECHNOLOGIES, LLC); 2 October 2014; figure 5 ; 43

paragraphs 41-43, 50, 52, 7 1

Y US 2012/0046756 A 1 (WANG, Y et al.) 23 February 2012; figures 5A-C; paragraphs 9 . 26-32, 1-31 , 45-46
34- 35, 37, 57-58, 70, 80, 8 3
Y
US 200G/0184231 A 1 (RUCKER, B) 17 August 2(Jub; figures 5-7; paragraphs 4 , 7 , 2 1 , 27-29, 1-31 , 34, 40, 45-46
Y 38, 44-45

Y U S 2009/0099639 A 1 (SABARIA, P) 16 April 2009; paragraphs 5 , 2 1, 6 0 6-10, 45-46

Y US 5,336,163 A (DEMANE, C et al.) 9 August 1994; column 3 , lines 17-27; column 4 , lines 12
35- 4 0

Y US 2006/106361 A 1 (MUNI, K e t al.) 18 May 2006; paragraphs 95, 102, 160, 163-164, 177, 179 13-16, 30-31

Y US 2002/0002400 A 1 (DRASLtK, W e t al.) 3 January 2002; paragraph 99, 1 1 19, 37

Y U S 2009/0266365 A 1 (OBERLE, P ) 2 9 October 2009; figure 13; paragraphs 36, 38-39 35- 36

Y US 2008/0009936 A 1 (KIM, J et al.) 10 January 2008; figure 1; paragraphs , 29 38

Further documents are listed in the continuation of Box C . | | See patent family annex.

Special categories of cited documents: "T" later document published after the international filing date or priority
A" document defining the general state of the art which is not considered date and not in conflict with the application but cited to understand
to be of particular relevance the principle or theory underlying the invention
E" earlier application or patent but published on or after the international "X" document of particular relevance; the claimed invention cannot be
filing date considered novel or cannot be considered to involve an inventive
L" document which may throw doubts on priority claim(s) or which is step when the document is taken alone
cited to establish the publication date of another citation or other
special reason (as specified)
"Y" document of particular relevance; the claimed invention cannot be
considered to involve an inventive step when the document is
O" document referring to an oral disclosure, use, exhibition or other combined with one or more other such documents, such combination
means being obvious to a person skilled in the art
P" document published prior to the international filing date but later than "&" document member of the same patent family
the priority date claimed

Date of the actual completion o f the international search Date of mailing of the international search report

5 July 2016 (05.07.2016)

6
Name and mailing address of the ISA/ Authorized officer
Mail Stop PCT, Attn: ISA/US, Commissioner for Patents Shane Thomas
P.O. Box 1450, Alexandria, Virginia 22313-1450
Facsimile No. 571-273-8300

Form PCT/lSA/2 10 (second sheet) (January 201 5)

 INTERNATIONAL SEARCH REPORT International application No.
PCT/IL1 5/51 153

C (Continuation). DOCUMENTS CONSIDERED TO BE RELEVANT

Category* Citation of document, with indication, where appropriate, of the relevant passages Relevant to claim No.

US 2003/0149472 A 1 (PINCHUK, L et al.) 7 August 2003; figure 1 1; paragraphs 5, 18, 21, 38, 41-42
41

Y US 2005/0251 193 A 1 (LARY, G) 10 November 2005; figure 7 ; paragraph 36 42

A US 2014/U243950 A 1 (BOSTON SCIENTIFIC SCIMED, INC.) 28 August 2014; figure 3; 47-49

paragraphs 38-39, 92; claim 4

US 2003/0004563 A 1 (JACKSON, G et al.) 2 January 2003; paragraphs 29, 35, 42 47-49

Form PCT/ISA/2 10 (continuation of second sheet) (January 201 5)

 INTERNATIONAL SEARCH REPORT International application No.

PCT/IL1 5/51 53

Box No. II Observations where certain claims were found unsearchable (Continuation of item 2 of first sheet)

This international search report has not been established in respect of certain claims under Article 17(2)(a) for the following reasons:

□ Claims Nos.:
because they relate to subject matter not required to be searched by this Authority, namely:

□ Claims Nos.:
because they relate to parts of the international application that do not comply with the prescribed requirements to such an
extent that no meaningful international search can be carried out, specifically:

Π Claims Nos.:
because they are dependent claims and are not drafted in accordance with the second and third sentences of Rule 6.4(a).

Box No. Ill Observations where unity of invention is lacking (Continuation of item 3 of first sheet)

This International Searching Authority found multiple inventions in this international application, as follows:
See extra sheet.

I. □
I I As all required additional search fees were timely paid by the applicant, this international search report covers all searchable
claims.

As all searchable claims could be searched without effort justifying additional fees, this Authority did not invite payment
additional fees

As only some of the required additional search fees were timely paid by the applicant, this international search report
only those claims for which fees were paid, specifically claims Nos.:

1-43 and 49-56

No required additional search fees were timely paid by the applicant. Consequently, this international search report is
restricted to the invention first mentioned in the claims; it is covered by claims Nos.:

The additional search fees were accompanied by the applicant's protest and, where applicable, the
payment of a protest fee.
The additional search fees were accompanied by the applicant's protest but the applicable protest
fee was not paid within the time limit specified in the invitation.
No protest accompanied the payment of additional search fees.

Form PCT/ISA/2 10 (continuation of first sheet (2)) (January 201 5)

 INTERNATIONAL SEARCH REPORT Internationa! application No.
Information on patent family members
PCT/IL15/51 153

-""-Continued from Box No. Ill Observations where unity of invention is lacking-*"-

This application contains the following inventions or groups of inventions which are not so linked as to form a single general inventive
concept under PCT Rule 13.1. In order for all inventions to be examined, the appropriate additional examination fee must be paid.

Group I: Claims 1-31 are directed toward a method of treatment of nasal conditions including removing an expandable structure.

Group II: Claims 44-48 are directed toward an expandable structure for expansion inside a body lumen including a polymer portion with
time-based expansion stability.

Group III: Claims 32-43 and 49-56 are directed toward expandable structures table over a range of diameters and comprising specific
concentrations of polymers.

The inventions listed as Groups l-lll do not relate to a single general inventive concept under PCT Rule 13.1 because, under PCT Rule
13.2, they lack the same or corresponding special technical features for the following reasons:

The special technical features of Group I include removing said structure from said nasal lumen, after a time period, where removing
comprises causing said structure to self-crimp, which is not present in Groups II and III.

The special technical features of Group II include a polymer portion which is elastic upon expansion of less than a minimum expansion
time period; wherein, for an expansion to an expanded state for a time period of more than said minimum expansion time period, said
structure remains in said expanded state, which are not present in Groups and III.

The special technical features of Group III include wherein said structure is stable for a range of diameters and for varying diameters
a g a structure length; and said polymer portion having a non-uniform cross section including a peripheral layer composed at least
partially of a second polymer, and a frame composed at least partially of a first polymer; wherein an average concentration of said first
polymer in said frame is at least twice an average concentration of said first polymer in said peripheral layer and wherein an average
concentration of said second polymer in said peripheral layer is at least twice an average concentration of said second polymer in said
frame; said second polymer having a greater environmental durability than said first polymer and wherein said first polymer has a higher
creep resistance than said second polymer, which are not present in Groups I and II.

The common technical features shared by Groups l-lll are delivering an expandable structure to a nasal lumen; expanding said
expandable structure within said nasal lumen to a stable expanded configuration; wherein the expandable structure comprises a polymer
portion; and wherein an event occurs related to the structure after a a time period.

However, these common features are previously disclosed by US 2012/0046756 A 1 to Wang, Y et al. (hereinafter 'Wang'). Wang
discloses delivering an expandable structure to a nasal lumen (a radially expandable stent is disposed in the nasal passageway,
paragraph [001 1]); expanding said expandable structure within said nasal lumen to a stable expanded configuration (stent is expanded
using a balloon, which is then removed leavnig t stent behind In Its expanded configuration to hold open the nasal passageway
(stable), paragraph [0029]); wherein the expandable structure comprises a polymer portion (stent comprises structural elements
including hydrogel-forming and galssy polymers, paragraph [001 1]); and wherein an event occurs related to the structure after a a time
period (polymer may be designed to prevent swelling for a set period of time, paragi apl i [00 11]).

Since the common technical features are previously disclosed by the Wang reference, these common features are not special and so
Groups l-lll lack unity.

Form PCT/ISA/2 10 (patent family annex) (January 2015)