JPWO2021087476A5 - - Google Patents
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- JPWO2021087476A5 JPWO2021087476A5 JP2022526091A JP2022526091A JPWO2021087476A5 JP WO2021087476 A5 JPWO2021087476 A5 JP WO2021087476A5 JP 2022526091 A JP2022526091 A JP 2022526091A JP 2022526091 A JP2022526091 A JP 2022526091A JP WO2021087476 A5 JPWO2021087476 A5 JP WO2021087476A5
- Authority
- JP
- Japan
- Prior art keywords
- chamber
- baffle
- wall
- port
- slope
- Prior art date
- Legal status (The legal status is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the status listed.)
- Granted
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Description
請求項並びに明細書において、「~を備える」、「~を含む」、「~を運ぶ」、「~を有する」、「~を収容する」、「~を伴う」、「~を保持する」、「~で構成される」及びこれに類する移行句は、オープンエンドなものと、即ち~を含むが~に限定されない、ことを意味するものと解釈すべきである。移行句「~にから成る」及び「基本的に~から成る」のみは、特許審査手続の米国特許庁マニュアルの第2111.03節に記されるそれぞれ閉鎖的又は半閉鎖的な移行句とする。
なお、本発明の実施態様として、以下に示すものがある。
[態様1]
アセンブリを含む生物医学的パッケージシステムであって:
液体栄養培地とバイオ人工臓器(BAO)とを保持するように構成された第1チャンバと;
第1分室に隣接して配置され、実質的に液体を含まないように構成された第2チャンバと;
ポートを含み、前記第1チャンバと前記第2チャンバとを分離するように構成されたバッフルと、
を備える、生物医学的パッケージシステム。
[態様2]
第2チャンバがフランジを含む、態様1に記載のシステム。
[態様3]
各チャンバが壁を含む、態様1又は2に記載のシステム。
[態様4]
前記第1チャンバの壁は、前記第2チャンバの壁と一体である、態様3に記載のシステム。
[態様5]
前記第2チャンバの壁が、前記バッフルの周囲を保持するか、あるいは支持するように構成された段縁部を含む、態様1~4のうちいずれかの態様に記載のシステム。
[態様6]
前記第2チャンバの壁が、前記バッフルの周囲を保持するか、あるいは支持するように構成された凹部を含む、態様1~4のうちいずれかの態様に記載のシステム。
[態様7]
前記バッフルの周囲及び前記第1チャンバの壁及び/又は第2チャンバの壁の内周の少なくとも1つが、前記バッフルの周囲を第1チャンバの壁及び/又は第2チャンバの壁でシールするように構成された物質を含む、態様1~6のうちいずれかの態様に記載のシステム。
[態様8]
前記第2チャンバが、前記フランジ真上又は前記フランジ上方の非透過性膜でシールされる、態様1~7のうちいずれかの態様に記載のシステム。
[態様9]
前記ポートが、前記バッフル上に中央に配置されている、態様1~8のうちいずれかの態様に記載のシステム。
[態様10]
前記ポートが、少なくとも1つの閉鎖システムを介して閉鎖される、態様1~9のうちいずれかの態様に記載のシステム。
[態様11]
前記バッフルが、傾斜を有して構成されている、態様1~10のうちいずれかの態様に記載のシステム。
[態様12]
傾斜は、前記バッフルの端から前記バッフルの中心まで形成される、態様1~11のうちいずれかの態様に記載のシステム。
[態様13]
前記傾斜が、約5度~30度の間である、態様11又は12に記載のシステム。
[態様14]
前記バッフルが、前記第1チャンバへの液体の充填中にガスを通気するように構成されている、態様1~13のうちいずれかの態様に記載のシステム。
[態様15]
前記バッフルが、前記第1チャンバ及び前記第2チャンバのうち少なくとも1つにシールされている、態様1~14のうちいずれかの態様に記載のシステム。
[態様16]
態様15記載のシステムにおいて、シーリングは超音波溶接を含む、システム。
[態様17]
前記閉鎖システムが、螺合を用いて構成されている、態様10に記載のシステム。
[態様18]
前記閉鎖システムが栓を含む、態様10に記載のシステム。
[態様19]
前記閉鎖システムが、栓及び対応する受け口を含む、態様10に記載のシステム。
[態様20]
前記栓と前記受け口は、螺合を介して互いに結合する、態様19に記載のシステム。
[態様21]
前記栓及び前記受け口にルアーテーパーが含まれる、態様19に記載のシステム。
[態様22]
前記栓と前記受け口が、互いに摩擦嵌めするように構成されているか、又は追加的に摩擦嵌めするように構成されている、態様19~21のうちいずれかの態様に記載のシステム。
[態様23]
閉鎖システムが、先細りすることができるシールを更に含む、態様10~22のうちいずれかの態様に記載のシステム。
[態様24]
前記栓上に配置された少なくとも1つのOリングを更に含む、態様18~19に記載のシステム。
[態様25]
前記受け口が、少なくとも1つのOリングを受けるように構成された少なくとも1つの対応する凹部を含む、態様24に記載のシステム。
[態様26]
前記栓及び受け口の少なくとも1つが、医療機器又はBAOの少なくとも1つを支えるための接合部分を含む、態様19~25のうちいずれかの態様に記載のシステム。
[態様27]
前記バッフルのポートが、前記栓及び受け口の少なくとも1つを受け入れるように構成されたネック部を含む、態様19~26のうちいずれかの態様に記載のシステム。
[態様28]
前記栓及び前記受け口の少なくとも1つとネック部が、前記栓及び前記受け口の少なくとも1つと前記ネック部とを接続するように構成された対応する接続手段を含む、態様27に記載のシステム。
[態様29]
貯蔵容器をさらに含む、態様1~28のうちいずれかの態様に記載のシステム。
[態様30]
前記第1チャンバ、前記第2チャンバ、前記バッフル、及び貯蔵容器のうち1つ以上の少なくとも一部が、透明性、医療用、耐久性、非分解性、高温、高pH及び/又は高湿度への曝露中に賦形剤の経時的な放出が実質的にない、という特性のうち、少なくとも1つの特性を有する物質で製造される、態様1~29のうちいずれかの態様に記載のシステム。
[態様31]
前記第1チャンバ、前記第2チャンバ、前記バッフル、及び貯蔵容器のうち1つ以上の少なくとも部分が、ポリカーボネート、ポリエステル樹脂、ポリエーテルアミド、ポリエチレンテレフタレート、及びポリエチレンコ-グリコールテレフタレートのうち少なくとも1つから製造される、態様1~29のうちいずれかの態様に記載のシステム。
[態様32]
開示された実施形態のいずれかによるシステム、装置、装置、又は方法。
In the claims and specification, "comprising", "containing", "carrying", "having", "accommodating", "accompanying", "holding" , "consisting of" and similar transitional phrases should be construed to mean open-ended, ie, including but not limited to. The only transitional phrases “consisting of” and “consisting essentially of” are closed or semi-closed transitional phrases, respectively, as described in Section 2111.03 of the United States Patent Office Manual of Patent Examination Procedures. .
In addition, some embodiments of the present invention are shown below.
[Aspect 1]
A biomedical packaging system comprising:
a first chamber configured to hold a liquid nutrient medium and a bioartificial organ (BAO);
a second chamber disposed adjacent to the first compartment and configured to be substantially liquid-free;
a baffle including a port and configured to separate the first chamber and the second chamber;
A biomedical packaging system comprising:
[Aspect 2]
The system of aspect 1, wherein the second chamber includes a flange.
[Aspect 3]
3. A system according to aspect 1 or 2, wherein each chamber includes a wall.
[Aspect 4]
4. The system of aspect 3, wherein the first chamber wall is integral with the second chamber wall.
[Aspect 5]
5. The system of any of aspects 1-4, wherein a wall of the second chamber includes a stepped edge configured to retain or support a perimeter of the baffle.
[Aspect 6]
5. The system of any of aspects 1-4, wherein a wall of the second chamber includes a recess configured to retain or support a perimeter of the baffle.
[Aspect 7]
at least one of a periphery of the baffle and an inner periphery of the first chamber wall and/or the second chamber wall to seal the baffle periphery with the first chamber wall and/or the second chamber wall; 7. A system according to any one of embodiments 1 to 6, comprising a material configured.
[Aspect 8]
8. The system of any of aspects 1-7, wherein the second chamber is sealed with an impermeable membrane directly above or above the flange.
[Aspect 9]
9. The system of any of aspects 1-8, wherein the port is centrally located on the baffle.
[Aspect 10]
10. The system according to any of aspects 1-9, wherein the port is closed via at least one closure system.
[Aspect 11]
11. The system according to any one of aspects 1-10, wherein the baffle is configured with a slope.
[Aspect 12]
12. The system of any of aspects 1-11, wherein a slope is formed from an edge of the baffle to a center of the baffle.
[Aspect 13]
13. The system according to aspect 11 or 12, wherein the slope is between about 5 degrees and 30 degrees.
[Aspect 14]
14. The system of any of aspects 1-13, wherein the baffle is configured to vent gas during filling of the first chamber with liquid.
[Aspect 15]
15. The system of any of aspects 1-14, wherein the baffle is sealed to at least one of the first chamber and the second chamber.
[Aspect 16]
16. The system of aspect 15, wherein the sealing comprises ultrasonic welding.
[Aspect 17]
11. The system of aspect 10, wherein the closure system is configured using a threaded fit.
[Aspect 18]
11. The system of aspect 10, wherein the closure system includes a spigot.
[Aspect 19]
11. The system of aspect 10, wherein the closure system includes a spigot and a corresponding receptacle.
[Aspect 20]
20. The system of aspect 19, wherein the stopper and the receptacle are coupled together via a threaded engagement.
[Aspect 21]
20. The system of aspect 19, wherein the stopper and the receptacle include a luer taper.
[Aspect 22]
22. The system according to any of aspects 19-21, wherein the bung and the receptacle are configured or additionally configured to frictionally fit each other.
[Aspect 23]
23. The system according to any of aspects 10-22, wherein the closure system further comprises a seal that is capable of tapering.
[Aspect 24]
20. The system according to aspects 18-19, further comprising at least one O-ring disposed on the bung.
[Aspect 25]
25. The system of aspect 24, wherein the receptacle includes at least one corresponding recess configured to receive at least one O-ring.
[Aspect 26]
26. The system of any of aspects 19-25, wherein at least one of the stopper and receptacle includes an interface for supporting at least one of a medical device or a BAO.
[Aspect 27]
27. The system of any of aspects 19-26, wherein the baffle port includes a neck configured to receive at least one of the bung and the receptacle.
[Aspect 28]
28. A system according to aspect 27, wherein the spigot and at least one of the receptacles and the neck portion include corresponding connection means configured to connect the at least one of the spigot and the receptacle and the neck portion.
[Aspect 29]
29. The system according to any of embodiments 1-28, further comprising a storage container.
[Aspect 30]
At least a portion of one or more of the first chamber, the second chamber, the baffle, and the storage container is transparent, medical grade, durable, non-degradable, susceptible to high temperatures, high pH and/or high humidity. 30. The system according to any one of aspects 1-29, wherein the system is made of a material having at least one of the following properties: there is substantially no release of excipient over time during exposure to the excipient.
[Aspect 31]
at least a portion of one or more of the first chamber, the second chamber, the baffle, and the storage vessel is made of at least one of polycarbonate, polyester resin, polyether amide, polyethylene terephthalate, and polyethylene co-glycol terephthalate. 30. A system according to any of embodiments 1-29, manufactured.
[Aspect 32]
A system, apparatus, apparatus, or method according to any of the disclosed embodiments.
Claims (15)
第1チャンバに隣接して配置され、実質的に液体を含まないように構成された第2チャンバ(104)と;
を備える、アセンブリを含む生物医学的パッケージシステム(100)であって、前記システムは、
ポート(108)を含み、前記第1チャンバ(102)と前記第2チャンバ(104)とを分離するように構成されたバッフル(106)と、
を備える、ことを特徴とする、生物医学的パッケージシステム。 a first chamber (102) configured to hold a liquid nutrient medium and a bioartificial organ (BAO);
a second chamber (104) disposed adjacent to the first chamber and configured to be substantially liquid-free;
A biomedical packaging system (100) comprising an assembly comprising:
a baffle (106) including a port (108) and configured to separate the first chamber (102) and the second chamber (104 ) ;
A biomedical packaging system comprising :
Applications Claiming Priority (5)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| US201962929619P | 2019-11-01 | 2019-11-01 | |
| US62/929,619 | 2019-11-01 | ||
| US201962930504P | 2019-11-04 | 2019-11-04 | |
| US62/930,504 | 2019-11-04 | ||
| PCT/US2020/058581 WO2021087476A1 (en) | 2019-11-01 | 2020-11-02 | System, apparatuses, devices, and methods for packaging an analyte diffusive implantable device |
Publications (3)
| Publication Number | Publication Date |
|---|---|
| JP2022553850A JP2022553850A (en) | 2022-12-26 |
| JPWO2021087476A5 true JPWO2021087476A5 (en) | 2023-11-10 |
| JP7821727B2 JP7821727B2 (en) | 2026-02-27 |
Family
ID=73699393
Family Applications (3)
| Application Number | Title | Priority Date | Filing Date |
|---|---|---|---|
| JP2022526091A Active JP7821727B2 (en) | 2019-11-01 | 2020-11-02 | Systems, apparatus, devices, and methods for packaging implantable analyte diffusion devices |
| JP2022526088A Active JP7783807B2 (en) | 2019-11-01 | 2020-11-02 | Systems, devices, instruments and methods for implantable analyte diffusion devices |
| JP2025209544A Pending JP2026020382A (en) | 2019-11-01 | 2025-11-28 | Systems, devices, instruments and methods for implantable analyte diffusion devices |
Family Applications After (2)
| Application Number | Title | Priority Date | Filing Date |
|---|---|---|---|
| JP2022526088A Active JP7783807B2 (en) | 2019-11-01 | 2020-11-02 | Systems, devices, instruments and methods for implantable analyte diffusion devices |
| JP2025209544A Pending JP2026020382A (en) | 2019-11-01 | 2025-11-28 | Systems, devices, instruments and methods for implantable analyte diffusion devices |
Country Status (9)
| Country | Link |
|---|---|
| US (2) | US20240180686A1 (en) |
| EP (2) | EP4051192B1 (en) |
| JP (3) | JP7821727B2 (en) |
| KR (2) | KR20220123632A (en) |
| AU (2) | AU2020375056A1 (en) |
| CA (2) | CA3156941A1 (en) |
| ES (1) | ES3051360T3 (en) |
| IL (2) | IL292640A (en) |
| WO (2) | WO2021087476A1 (en) |
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| US5868253A (en) * | 1996-03-29 | 1999-02-09 | St. Jude Medical, Inc. | Hinged support collar for mechanical heart valve packaging |
| US5720391A (en) * | 1996-03-29 | 1998-02-24 | St. Jude Medical, Inc. | Packaging and holder for heart valve prosthesis |
| US6361771B1 (en) | 1999-04-06 | 2002-03-26 | Neurotech S.A. | ARPE-19 as a platform cell line for encapsulated cell-based delivery |
| US6199696B1 (en) * | 1999-05-26 | 2001-03-13 | Sulzer Carbomedics Inc. | Shock resistant packaging for a prosthetic heart valve |
| US6830149B2 (en) * | 2002-03-08 | 2004-12-14 | Musculoskeletal Transplant Foundation | Package with insert for holding allograft implant to preclude lipid transfer |
| US8128740B2 (en) * | 2003-04-04 | 2012-03-06 | Organ Recovery Systems, Inc. | Device for separating gas from a liquid path |
| ES2315842T3 (en) * | 2004-01-19 | 2009-04-01 | Nsgene A/S | HUMAN THERAPEUTIC CELLS THAT SECRET NERVOUS GROWTH FACTOR. |
| WO2006023175A2 (en) * | 2004-07-19 | 2006-03-02 | St. Jude Medical, Inc. | Heart valve support and lid liner system and methods |
| US7320404B2 (en) * | 2005-08-10 | 2008-01-22 | Zimmer Technology, Inc. | Medical packaging |
| GB2432897A (en) * | 2005-12-02 | 2007-06-06 | Planer Plc | Controlled rate freezer for biological material |
| EP1971288B1 (en) * | 2005-12-30 | 2013-02-13 | Neurotech USA, Inc. | Micronized device for the delivery of biologically active molecules and methods of use thereof |
| US9364215B2 (en) * | 2006-01-26 | 2016-06-14 | Covidien Lp | Medical device package |
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| US8679404B2 (en) * | 2010-03-05 | 2014-03-25 | Edwards Lifesciences Corporation | Dry prosthetic heart valve packaging system |
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| JP6125495B2 (en) * | 2011-06-09 | 2017-05-10 | シンセス・ゲーエムベーハーSynthes GmbH | Anodizing vessel |
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| CA2922483A1 (en) * | 2013-09-11 | 2015-03-19 | Neurotech Usa, Inc. | Encapsulated cell therapy cartridge |
| JP6850734B2 (en) | 2015-05-27 | 2021-03-31 | ニューロテック ユーエスエー, インコーポレイテッド | Use of Encapsulated Cell Therapy for the Treatment of Eye Disorders |
| US11679243B2 (en) * | 2019-05-08 | 2023-06-20 | David R. Elmaleh | Non-digestible, controlled release system for soluble drug delivery |
-
2020
- 2020-11-02 CA CA3156941A patent/CA3156941A1/en active Pending
- 2020-11-02 WO PCT/US2020/058581 patent/WO2021087476A1/en not_active Ceased
- 2020-11-02 ES ES20819924T patent/ES3051360T3/en active Active
- 2020-11-02 US US17/773,161 patent/US20240180686A1/en active Pending
- 2020-11-02 KR KR1020227017915A patent/KR20220123632A/en active Pending
- 2020-11-02 WO PCT/US2020/058589 patent/WO2021087481A1/en not_active Ceased
- 2020-11-02 AU AU2020375056A patent/AU2020375056A1/en active Pending
- 2020-11-02 KR KR1020227017910A patent/KR20220151598A/en active Pending
- 2020-11-02 JP JP2022526091A patent/JP7821727B2/en active Active
- 2020-11-02 JP JP2022526088A patent/JP7783807B2/en active Active
- 2020-11-02 AU AU2020375055A patent/AU2020375055B2/en active Active
- 2020-11-02 CA CA3156956A patent/CA3156956A1/en active Pending
- 2020-11-02 US US17/773,159 patent/US20240180682A1/en active Pending
- 2020-11-02 EP EP20819924.0A patent/EP4051192B1/en active Active
- 2020-11-02 EP EP20820593.0A patent/EP4051169A1/en active Pending
-
2022
- 2022-05-01 IL IL292640A patent/IL292640A/en unknown
- 2022-05-01 IL IL292641A patent/IL292641A/en unknown
-
2025
- 2025-11-28 JP JP2025209544A patent/JP2026020382A/en active Pending
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