Implantable artificial bronchus

Abstract

An implantable artificial bronchus, including a body having at least one fiber woven to form a lattice structure. The body includes a proximal upper opening and a distal lower opening in fluid communication with the proximal upper opening, and the body at least partially tapering along a length of the body toward the distal lower opening. The body further includes a first loop formed from the at least one fiber and disposed along the body between the proximal upper opening and the distal lower opening. A diameter of the proximal upper opening is larger than a diameter of the distal lower opening. The proximal upper opening is formed from a number of proximal loops and the distal lower opening is formed from a number of distal loops. The number of distal loops is less than the number of proximal loops.

Description

(12) INTERNATIONAL APPLICATION PUBLISHED UNDER THE PATENT COOPERATION TREATY (PCT) (19) World Intellectual Property lntc,;;; 笠cau 蔘 ::::::d WIPOI PCT 111111 1111111111 IIIIII IIIII 1 111111111 11111 II Ill lllll lllll lllll lllll lllll 1111 1111111111111111111 (43) International Publication Date 24 October 2024 (24.10.2024) (10) International Publication Number WO 2024 / 220855 Al (51) International Patent Classification: A61F 2 / 04 (2013.01) A61B 17112 (2006.01) A61F 2 / 90 (2013.01) (21) International Application Number: PCT / US2024 / 02548 l (22) International Filing Date: 19 April 2024 (19.04.2024) (25) Filing Language: (26) Publication Language: (30) Priority Data: 63 / 497,701 21 April 2023 (21.04.2023) English English us (71) Applicant: PULMAIRMEDICAL, INC. [US / US]; 12750 High Bluff Dr., Suite 480, San Diego, CA 92130 (US) (72) Inventors: LIMA, Marcelo G.; 4597 Vista De La Patria, Del Mar, CA 92014 (US). RADISCH, Herbert; 12680 Belle Fleur Way, San Diego, CA 92128 (US) (74) Agent: PARIKH, VishalJ. et al.; Morgan Lewis &Bockius LLP, 2222 Market Street, Philadelphia, PA 19103 (US) (81) Designated States (unless otherwise indicated, for every kind of national protection available): AE, AG, AL, AM, AO, AT, AU, AZ, BA, BB, BG, EH, EN, BR, BW, BY, BZ, CA, CH, CL, CN, CO, CR, CU, CV, CZ, DE, DJ, DK, DM, DO, DZ, EC, EE, EG, ES, FI, GB, GD, GE, GH, GM, GT, HN, HR, HU, ID, IL, IN, IQ, IR, IS, IT, JM, JO, JP, KE, KG, KH, KN, KP, KR, KW, KZ, LA, LC, LK, LR, LS, LU, LY, MA, MD, MG, MK, MN, MU, MW, MX, MY, MZ, NA, NG, NI, NO, NZ, OM, PA, PE, PG, PH, PL, PT, QA, RO, RS, RU, RW, SA, SC, SD, SE, SG, SK, SL, ST, SV, SY, TH, TJ, TM, TN, TR, TT, TZ, UA, UG, US, UZ, VC, VN, WS, ZA,ZM,ZW. ＿ ＿ ＿ ＿ ＿ ＿ ＿ ＿ ＿ ＿ ＿ ＿ ＿ ＿ ＿ ＿ ＿ ＿ ＿ ＿ ＿ ＿ ＿ ＿ ＿ ＿ ＿ ＿ ＿ ＿ ＿ ＿ ＿ ＿ ＿ ＿ (54) Title: IMPLANTABLE ARTIFICIAL BRONCHUS 100丶／ 104Y,12 ／ 108a < In (57) Abstract: An implantable血血al bronchus, including a body having at least one fiber woven to form a lattice structure. The 姜 body includes a proxima几pper opening and a distal lower opening in fluid communication with the proximal唧er opening, and the O body at least partially tapering along a length of the body toward the distal lower opening. The body fu呻er includes a first loop formed from the at least one fiber and disposed along the body between the proximal唧er opening and the distal lower opening. A diameter 、 of the proximal唧er opening is larger than a diameter of the distal lower opening. The proximal唧er opening is formed from a 苫 number of proximal loops and the distal lower opening is formed from a number of distal loops. The number of distal loops is less o than the number of proximal loops F!G.1 [Continued on next page] INTERNATIONAL SEARCH REPORT International唧lication No. PCT / US2024 / 025481 Box No. III Observations where unity of invention is lacking (Continuation of item 3 of first sheet) This International Searching Authority found multiple inventions in this international唧lication, as follows: 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 fees must be paid. Group I, claims 1-15 and 20, is drawn to an implantable artificial bronchus, comprising: a body comprised of at least one fiber woven to form a lattice structure. Group II, claims 16-19, is drawn to an implantable artificial bronchus, comprising: the body including a first portion between the proxima几pper opening and the loop. The inventions listed as Groups 1-11 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 feature of the Group I invention: the proximal upper opening is formed from a number of proximal loops and the distal lower opening is formed from a number of distal loops, the number of distal loops being less than the number of proximal loops as claimed therein is not present in the invention of Group IL The special technical feature of the Group II invention: the body includes a first portion between the proxima几pper opening and the loop, and a second portion between the loop and the distal lower opening, the second portion having substantially the same or greater flexibility than the first portion as claimed therein is not present in the invention of Group I. Groups I and II lack unity of invention because even though the inventions of these groups require the technical feature of an implantable artificial bronchus, comprising: a body comprised of at least one fiber, the body having a proximal upper opening and a distal lower opening in fluid communication with the proximal upper opening, the body at least partially tapering along a length of the body toward the distal lower opening and having a first loop formed from the at least one fiber and disposed along the body between the proximal upper opening and the distal lower opening, wherein a diameter of the proximal upper opening is larger than a diameter of the distal lower opening, this technical feature is not a special technical feature as it does not make a contribution over the prior art. Specifically, US 2022 / 0354631 to Pulmair Medical, Inc. teaches an implantable artificial bronchus, comprising: a body comprised of at least one fiber, the body having a proximal upper opening and a distal lower opening in fluid communication with the proximal upper opening, the body at least partially tapering along a length of the body toward the distal lower opening and having a first loop formed from the at least one fiber and disposed along the body between the proximal upper opening and the distal lower opening, wherein a diameter of the proxima几pper opening is larger than a diameter of the distal lower opening (As shown in FIGS. 1 and 2, implantable artificial bronchus 100 may include body 102, proximal upper opening 104, distal lower opening 106, wire or fiber 108, and side openings 110. Body 102 may be disposed between proximal upper opening 104 and distal lower opening 106, and may be comprised of a fiber 108. Implantable artificial bronchus 100 may be at least partially tapered to allow for the insertion into the bronchi and penetration of implantable artificial bronchus 100 within distal bronchioles that increasingly become narrower. For example, implantable artificial bronchus 100 may be deployed within the respiratory passageway such that proxima几pper opening 104 is disposed within the bronchi, and distal lower opening 106 is able to reach as close as possible to respiratory bronchioles at levels 9 to 15 (terminal bronchioles), para. 0038. Referring to FIGS. 1 and 2, proximal唧er opening 104 may be in fluid communication with distal lower opening 106 to allow for bi-directional airflow in and through implantable artificial bronchus 100. Proxima几pper opening 104 may have diameter Dl and distal lower opening 106 may have diameter D2. According to some embodiments, diameter D 1 of proximal upper opening 104 may be larger than diameter D2 of distal lower opening 106, para. 0043). Since none of the special technical features of the Group I or II inventions are found in more than one of the inventions, unity of invention is lacking. Form PCT / ISA / 210 (continuation of first sheet) (July 2022) 摘要 可植入的人工支气管包括具有至少一根纤维编织形成网格结构 的主体。主体包括近端上开口和与近端上开口流体连通的远端下开 口，并且主体至少部分地沿着主体的长度朝远端下开口渐缩。主体还 包括由至少一根纤维形成的第一环，该第一环沿着主体布置在近端上 开口和远端下开口之间。近端上开口的直径大于远端下开口的直径。 近端上开口由多个近端环形成并且远端下开口由多个远端环形成。远 端环的数量少于近端环的数量。

Claims

CLAIMSWhat is claimed is:

1. An implantable artificial bronchus, comprising: a body comprised of at least one fiber woven to form a lattice structure, the body having a proximal upper opening and a distal lower opening in fluid communication with the proximal upper opening, the body at least partially tapering along a length of the body toward the distal lower opening and having a first loop formed from the at least one fiber and disposed along the body between the proximal upper opening and the distal lower opening , wherein a diameter of the proximal upper opening is larger than a diameter of the distal lower opening, wherein the proximal upper opening is formed from a number of proximal loops and the distal lower opening is formed from a number of distal loops, the number of distal loops being less than the number of proximal loops.

2. The implantable artificial bronchus of claim 1, wherein the body includes a proximal portion, a first middle portion, a second middle portion, and a distal portion, the proximal portion being tapered radially inward towards a central axis of the body.

3. The implantable artificial bronchus of claim 2, wherein the first middle portion and the second middle portion are disposed between the proximal portion and the distal portion, the first middle portion being proximate the proximal portion and the second middle portion being proximate the distal portion, the first middle portion having a first taper and the second middle portion having a second taper, the second taper being larger than the first taper.

4. The implantable artificial bronchus of claim 2, wherein a diameter of the first middle portion is greater than a diameter of the proximal portion, a diameter of the second middle portion, and a diameter of the distal portion.

5. The implantable artificial bronchus of claim 4, wherein the diameter of the distal portion is less than the diameter of the proximal portion, the diameter of the first middle portion, and the diameter of the second middle portion.

6. The implantable artificial bronchus of claim 4, wherein the diameter of the first middle portion is equal to or less than the largest diameter of the body.

7. The implantable artificial bronchus of claim 4, wherein the diameter of the second middle portion constantly decreases along the length of the body from the first middle portion to the distal portion.

8. The implantable artificial bronchus of claim 4, wherein the diameter of the distal portion is substantially the same proximate the second middle portion and proximate distal lower opening.

9. The implantable artificial bronchus of claim 2, wherein the proximal portion flares out from the proximal upper opening to the first middle portion.

10. The implantable artificial bronchus of claim 1 further comprising: a plurality of side openings configured to allow air to enter into and exit the implantable artificial bronchus through the body.

11. The implantable artificial bronchus of claim 10, wherein the plurality of side openings include an angle ranging between approximately 130° proximate the proximal upper opening and 20° proximate the distal lower opening.

12. The implantable artificial bronchus of claim 10, wherein the plurality of side openings include a first side opening proximate the proximal upper opening and a second side opening proximate the distal lower opening, the first side opening having a first angle and the second side opening having a second angle less than the first angle.

13. The implantable artificial bronchus of claim 1, wherein the body is a web comprised of the at least one fiber forming the lattice structure, the at least one fiber having ends woven together proximate a middle portion of the body.

14. The implantable artificial bronchus of claim 1, wherein in an implanted state the body is configured to curve in a first radial direction along a first length of the body and a second radial direction opposite the first radial direction along a second length of the body.

15. The implantable artificial bronchus of claim 1, wherein the body includes a first loop formed from the at least one fiber and disposed along the body between the proximal upper opening and the distal lower opening such that the body includes a first portion between the proximal upper opening and the first loop, and a second portion between the first loop and the distal lower opening, the second portion having substantially the same or greater flexibility than the first portion.

16. An implantable artificial bronchus, comprising: a body comprised of at least one fiber and having a proximal upper opening and a distal lower opening in fluid communication with the proximal upper opening, the body at least partially tapering along a length of the body toward the distal lower opening and having a loop formed from the at least one fiber and disposed along the body between the proximal upper opening and the distal lower opening such that the body includes a first portion between the proximal upper opening and the loop, and a second portion between the loop and the distal lower opening, the second portion having substantially the same or greater flexibility than the first portion, wherein a diameter of the proximal upper opening is larger than a diameter of the distal lower opening.

17. The implantable artificial bronchus of claim 16, wherein the first portion has a greater density of portions of the fiber than the second portion.

18. The implantable artificial bronchus of claim 16, wherein the loop is a first loop and further comprising: a second loop disposed between the first loop and the distal lower opening, such that the body includes a third portion between the first loop and the second loop, and a fourth portion between the second loop and the distal lower opening, the fourth portion having the same or greater flexibility than the third portion, and the third portion having the same or greater flexibility than the first portion.

19. An implantable artificial bronchus, comprising: a body comprised of at least one fiber and having a proximal upper opening and a distal lower opening in fluid communication with the proximal upper opening, the body at least partially tapering along a length of the body toward the distal lower opening and having a loop formed from the at least one fiber and disposed along the body between the proximal upper opening and the distal lower opening such that the body includes a first portion between the proximal upper opening and the loop, and a second portion between the loop and the distal lower opening, the second portion having substantially the same or greater flexibility than the first portion, the body comprising: a proximal portion being tapered toward a central axis of the body; a first middle portion having a first middle taper; a second middle portion having a second middle taper larger than the first middle taper; and a distal portion having a constant distal diameter, wherein the first middle portion and the second middle portion are disposed between the proximal portion and the distal portion, wherein a diameter of the proximal upper opening is at least twice as large as a diameter of distal lower opening, and the diameter of the proximal upper opening is less than a maximum diameter of the body, the maximum diameter of the body being proximate the proximal upper opening, and wherein in an implanted state the body is configured to curve in a first radial direction along a first length of the body and a second radial direction opposite the first radial direction along a second length of the body.

20. A method of promoting lung disinsufflation, the method comprising: inserting a catheter distally into a respiratory passageway of a patient’s lung, the catheter containing the implantable artificial bronchus of claim 1 disposed within the catheter in a compressed state; and withdrawing the catheter proximally relative to the implantable artificial bronchus causing the implantable artificial bronchus to unsheathe and naturally expand into an expanded state such that the implantable artificial bronchus remains disposed within the respiratory passageway, wherein the implantable artificial bronchus being in the expanded state and disposed within the respiratory passageway results in at least a portion of the body abutting an inner wall of the respiratory passageway and prevents the proximal upper opening from contacting the inner wall of the respiratory passageway.

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