EP3393400A1 - An innovative biocompatible packaging system - Google Patents

An innovative biocompatible packaging system

Info

Publication number
EP3393400A1
EP3393400A1 EP16781878.0A EP16781878A EP3393400A1 EP 3393400 A1 EP3393400 A1 EP 3393400A1 EP 16781878 A EP16781878 A EP 16781878A EP 3393400 A1 EP3393400 A1 EP 3393400A1
Authority
EP
European Patent Office
Prior art keywords
lens
biocompatible
lid
package
innovative
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.)
Withdrawn
Application number
EP16781878.0A
Other languages
German (de)
French (fr)
Inventor
Pascal Bernard
Serkan ATMACA
Current Assignee (The listed assignees may be inaccurate. Google has not performed a legal analysis and makes no representation or warranty as to the accuracy of the list.)
VSY Biyoteknoloji ve Ilac Sanayi AS
Original Assignee
VSY Biyoteknoloji ve Ilac Sanayi AS
Priority date (The priority date 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 date listed.)
Filing date
Publication date
Application filed by VSY Biyoteknoloji ve Ilac Sanayi AS filed Critical VSY Biyoteknoloji ve Ilac Sanayi AS
Publication of EP3393400A1 publication Critical patent/EP3393400A1/en
Withdrawn legal-status Critical Current

Links

Classifications

    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61F—FILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
    • A61F2/00—Filters implantable into blood vessels; Prostheses, i.e. artificial substitutes or replacements for parts of the body; Appliances for connecting them with the body; Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents
    • A61F2/02—Prostheses implantable into the body
    • A61F2/14—Eye parts, e.g. lenses, corneal implants; Implanting instruments specially adapted therefor; Artificial eyes
    • A61F2/16—Intraocular lenses
    • A61F2/1691—Packages or dispensers for intraocular lenses

Definitions

  • This invention is related to a lens package consisting of one biocompatible material that enables the maintenance and transportation of intraocular lenses used especially in cataract surgeries in an impermeable and sterile environment in liquid inside package without risk of contamination.
  • lens packages consist of plastic aluminum, rubber and silicon parts.
  • aluminum lid is often used
  • sterile barriers produced from aluminum and other materials are used also on the inner surface of the package. These barriers and films are in layered structure and any problems that may occur during production may cause interaction between materials in the future. This interaction may cause release of toxic materials and degradation. Also these aluminum films may be pricked and this situation may not be noticed by the user. Leakage of the liquid outside the package or intrusion of some materials inside the package hinders the protection and sterility of the lens.
  • there are difficulties during opening aluminum lids and blister packages Because of the difficulties experienced during the opening of the blister package, package can be opened suddenly and liquid inside the package can be splashed to the outer environment.
  • an innovative biocompatible lens package is manufactured from a single biocompatible material. It does not contain any second material, sterile barrier or intermediary film. With this structure, the intent is to prevent damaging on the lens and enable maintenance and transportation in a sterile and safe environment.
  • the purpose of this invention is to develop an innovative biocompatible lens package to maintain the lens in a sterile environment.
  • Another purpose of this invention is to realize an innovative biocompatible lens package to maintain the lens in an environment without contamination risk.
  • Another purpose of this invention is to realize an innovative biocompatible lens package for transportation of the lens without damaging it.
  • Another purpose of the invention is to realize an innovative biocompatible lens package that can be easily opened and cannot slip easily from the hand of the user during opening.
  • Another purpose of this invention is to realize a disposable innovative biocompatible lens package that provides information to the user if the lid has been previously opened or not.
  • Another purpose of the invention is to realize an innovative biocompatible lens package with more simple production method and lower cost that has a one-piece and single material structure.
  • Figure 1 - is the side view of the present invention biocompatible lens packaging system.
  • Figure 2 - is the internal sectional view of the present invention biocompatible lens packaging system.
  • a lens package (1) contains basically;
  • At least one holder (2) produced with a biocompatible material located in the middle of the system preventing the contact of the lens to surfaces and preventing damage during transport,
  • At least one container (3) produced with one biocompatible material, At least a lid (4) mechanically connected to the container (3) with the same biocompatible material,
  • At least one connecting extension (5) produced with same biocompatible material, extending from the inner surface of the lid (4) to the container (3) enabling the sticking of the lens holder (2) to the lid due to its recessed structure
  • At least one line of rupture (6) produced with same biocompatible material, that provides opening of the lid (4) and gives the information if the lid opened before or not to the user,
  • At least one nonslip claw(7) produced with same biocompatible material, that is on the container' s(3) and the lid's(4) surfaces, increases the friction on the surface to prevent slipping easily from the hand of the user during opening the lid,
  • At least one base (8) produced with same biocompatible material.
  • the container (3) and the lid (4) was produced by the same biocompatible material. During manufacturing process, the container (3) and the lid (4) are connected to each other mechanically and directly. Thus, the lens package (1) has a one-piece and single material structure. By this structure of the lens package (1), the liquid in which the lens stayed is prevented to leak to environment and contamination.
  • the lid (5) and the container (4) is assembled by thermal sealing. The container (3) and the lid (4) have the maximum ability to seal each other because of manufacturing from the same material.
  • Thermal sealing is an operation that seals a thermoplastic to another similar thermoplastic by using heat and pressure.
  • a mold that heated continuously or a sealing rod are used for to apply heat to a certain contact part or way, or to boil or seal thermoplastics to each other.
  • Thermal sealing is used in many applications including; thermo sealing connecting parts, sticky tapes activated with heat and sealing film or folio.
  • Medical product industries that produce pockets or elastic pots used thermal sealing to weld parietal the pocket's plastic materials or to weld tubes and apertures to the pockets.
  • thermal sealing hot sealing rods, pushing sealers etc.
  • Biocompatibility is related to the biomaterial's behaviors in various situations.
  • the term express the material's reacting capability in the body in certain situation.
  • the ambiguity of the term reflect , how the biomaterials interact with the human body and eventually how these interactions determine the clinical success of a medical device (cardiac pacemaker, femur artroplasty or stent).
  • Contamination term is used to define the harmful attacks such as the presence of the pathogen and toxin in the pharmaceutical medicines or nutrition. Since that the present invention an innovative biocompatible lens package(l) is produced with monotype material, there are no interaction among materials and this minimize the contamination risk.
  • Lens holder (2) is attached at the middle of the lid (4) for choice. Due to this, it prevents the lens contact to the surfaces and the damage during the transportation.
  • Lens holder (2) consist of body (21) that has ledge to attach the connecting extensions recess part, nails (22) that can wrap the lens with applied any of pressure, clamps (23) that has the pit the lenses can put in it and put the lenses fixed.
  • Production of the lens holder (2) with an elastic material provides the convergence of the nails (22) and clamps to each other, thus the lens can be wrapped.
  • Clamps (23) and the nails (22) can be perpendicular to each other or having angles between them.
  • lens holder (2) is produced with the same biomaterial with the container (4) and the lid (5).
  • the connecting extension (5) lie down from lid's (4) inside surface through the container (4) and with its recessed surface it can clamp the lens holder (2) to the lid (4).
  • the connecting extension (5) is produced as an extension of the lid (4) during the manufacturing of the lid (4).
  • the lens holder (2) is binded mechanically to the lid (4) by the connecting extension (5) in production process.
  • There are nonslip claws(7) on the container(3) and the lid (4) provides not to slip easily from the hand of the user during opening the lid (4).
  • These nonslip rims(7) can be transverse, longitudinal, inclined or curvilinear and in the form of recess or ledge. This shape structure creates an additional friction force during the user holding and opening of lens package(l).
  • the lid (4) can be opened ergonomically. The leakage of the liquid outside the package and damaging on the lens are preventing by not slipping of the innovative biocompatible lens package from the hand of user.
  • the nonslip claws (7) that on the side of the lid(4) are the shape of ledge and lie down parallel through the lids(4) side.
  • the nonslip claws (7) on the side of the container (3) are the shape of recess and lie down parallel through the containers (3) side.
  • this lens package(l) at the container' s(3) and the lid's(4) connection surface, there is the line of rupture(6) that is formed during the production process, provides separation of the lid(4) from the container(3) and opening the package(l).
  • This line of rupture(6) can be the area that thermal operation is performed. The line of rupture(6) that can be broken down by user's force , separate the container(3) and the lid(4) easily.
  • the lens holder (2) is attached to the middle of the lid (5) to prevent the lens touching the surface of the biocompatible packaging system (1) and the damages on the lens in quakes.
  • the location of the lens holder (2) gives the information to the user about the location of lens during the opening of lid (5) and taking the lens from the package (1).
  • the liquid in the package (1) stay in the container(4) and the lens stay in the lid(5) since that the lens holder (2) is attached to the lid(5).
  • the package (1) can be opened with no hand touching to the lens and the liquid in it.
  • the environment does not dirty during the opening since he liquid does not leak to the ambient. The damage of the lens while taking of the lens from the biocompatible packaging system (1) is prevented.
  • material that lens package is manufactured from is preferentially medical grade polypropylene, polycarbonate , Polyetherimide or other biocompatible material adapted to the present invention.
  • Mentioned invention biocompatible packaging system is resistant to steam sterilization at 121°C until 30 minutes and 25kGy gamma radiation.
  • the mechanism of the biocompatible packing system (1) and the lens holder (2) can be changed and the package can be used for transporting another type of lens or medical materials

Abstract

This invention is related to an innovative biocompatible lens packaging system containing at least one lens holder (2), at least one container (3), at least one lid (4), at least one connecting extension (5), at least one breaking line (6), at least one nonslip claws (7) and at least base (8) which are produced with only one biocompatible material.

Description

DESCRIPTION
AN INNOVATIVE BIOCOMPATIBLE PACKAGING SYSTEM Technical Area
This invention is related to a lens package consisting of one biocompatible material that enables the maintenance and transportation of intraocular lenses used especially in cataract surgeries in an impermeable and sterile environment in liquid inside package without risk of contamination.
Prior Art
At the present time during cataract surgeries, crystalline lens which lost its transparency is taken out and instead intraocular lenses are injected. This technic is not used only in cataract surgeries but also in surgeries concerning other visual defects. Maintenance of the intraocular lenses under sterile conditions carries a great importance for patient's health. These lenses are maintained in a conserving liquid. Therefore they need packages specifically designed for containing the liquid inside for protection.
At present technic, lens packages consist of plastic aluminum, rubber and silicon parts. The use of many different materials introduces the risk of material interaction. In lens packages, aluminum lid is often used At the same time, sterile barriers produced from aluminum and other materials are used also on the inner surface of the package. These barriers and films are in layered structure and any problems that may occur during production may cause interaction between materials in the future. This interaction may cause release of toxic materials and degradation. Also these aluminum films may be pricked and this situation may not be noticed by the user. Leakage of the liquid outside the package or intrusion of some materials inside the package hinders the protection and sterility of the lens. In the current technic, there are difficulties during opening aluminum lids and blister packages. Because of the difficulties experienced during the opening of the blister package, package can be opened suddenly and liquid inside the package can be splashed to the outer environment.
Present invention; an innovative biocompatible lens package is manufactured from a single biocompatible material. It does not contain any second material, sterile barrier or intermediary film. With this structure, the intent is to prevent damaging on the lens and enable maintenance and transportation in a sterile and safe environment.
Brief Description of the Invention
The purpose of this invention is to develop an innovative biocompatible lens package to maintain the lens in a sterile environment.
Another purpose of this invention is to realize an innovative biocompatible lens package to maintain the lens in an environment without contamination risk. Another purpose of this invention is to realize an innovative biocompatible lens package for transportation of the lens without damaging it.
Another purpose of the invention is to realize an innovative biocompatible lens package that can be easily opened and cannot slip easily from the hand of the user during opening.
Another purpose of this invention is to realize a disposable innovative biocompatible lens package that provides information to the user if the lid has been previously opened or not.
Another purpose of the invention is to realize an innovative biocompatible lens package with more simple production method and lower cost that has a one-piece and single material structure. Description of the Invention
In order to to fulfill the purpose of this invention, "An innovative biocompatible lens package" is illustrated in the attached drawings and these drawings;
Figure 1 - is the side view of the present invention biocompatible lens packaging system.
Figure 2 - is the internal sectional view of the present invention biocompatible lens packaging system.
Parts shown in figure are individually numbered and their numbers are given below.
1. Lens package
2. Lens Holder
21. Body
22. Nail
23. Clamp
3. Container
4. Lid
5. Connecting Extension
6. Line of Rupture
7. Nonslip Claws
8. Base Cylinder
Present invention a lens package (1) contains basically;
- At least one holder (2) produced with a biocompatible material located in the middle of the system preventing the contact of the lens to surfaces and preventing damage during transport,
At least one container (3) produced with one biocompatible material, At least a lid (4) mechanically connected to the container (3) with the same biocompatible material,
At least one connecting extension (5) produced with same biocompatible material, extending from the inner surface of the lid (4) to the container (3) enabling the sticking of the lens holder (2) to the lid due to its recessed structure
At least one line of rupture (6) produced with same biocompatible material, that provides opening of the lid (4) and gives the information if the lid opened before or not to the user,
At least one nonslip claw(7) produced with same biocompatible material, that is on the container' s(3) and the lid's(4) surfaces, increases the friction on the surface to prevent slipping easily from the hand of the user during opening the lid,
At least one base (8) produced with same biocompatible material.
In the present invention biocompatible lens package (1), the container (3) and the lid (4) was produced by the same biocompatible material. During manufacturing process, the container (3) and the lid (4) are connected to each other mechanically and directly. Thus, the lens package (1) has a one-piece and single material structure. By this structure of the lens package (1), the liquid in which the lens stayed is prevented to leak to environment and contamination. One application of the invention, the lid (5) and the container (4) is assembled by thermal sealing. The container (3) and the lid (4) have the maximum ability to seal each other because of manufacturing from the same material.
Thermal sealing is an operation that seals a thermoplastic to another similar thermoplastic by using heat and pressure. In directly contact method of the thermal sealing, a mold that heated continuously or a sealing rod are used for to apply heat to a certain contact part or way, or to boil or seal thermoplastics to each other. Thermal sealing is used in many applications including; thermo sealing connecting parts, sticky tapes activated with heat and sealing film or folio. Medical product industries that produce pockets or elastic pots used thermal sealing to weld parietal the pocket's plastic materials or to weld tubes and apertures to the pockets. Several types of thermal sealing (hot sealing rods, pushing sealers etc.) are acceptable to add into thermoplastic materials such as plastic film.
Biocompatibility is related to the biomaterial's behaviors in various situations. The term express the material's reacting capability in the body in certain situation. The ambiguity of the term reflect , how the biomaterials interact with the human body and eventually how these interactions determine the clinical success of a medical device (cardiac pacemaker, femur artroplasty or stent). Contamination term is used to define the harmful attacks such as the presence of the pathogen and toxin in the pharmaceutical medicines or nutrition. Since that the present invention an innovative biocompatible lens package(l) is produced with monotype material, there are no interaction among materials and this minimize the contamination risk.
Lens holder (2) is attached at the middle of the lid (4) for choice. Due to this, it prevents the lens contact to the surfaces and the damage during the transportation.
Lens holder (2) consist of body (21) that has ledge to attach the connecting extensions recess part, nails (22) that can wrap the lens with applied any of pressure, clamps (23) that has the pit the lenses can put in it and put the lenses fixed. Production of the lens holder (2) with an elastic material provides the convergence of the nails (22) and clamps to each other, thus the lens can be wrapped. Clamps (23) and the nails (22) can be perpendicular to each other or having angles between them.
One application of the invention, lens holder (2) is produced with the same biomaterial with the container (4) and the lid (5).
Another application of the invention, there can be various mechanisms such as lens wrapping mechanism
Innovative biocompatible lens package(l) has one connecting extension (5) that can bind the lens holder (2) to the the lid (4). The connecting extension (5) lie down from lid's (4) inside surface through the container (4) and with its recessed surface it can clamp the lens holder (2) to the lid (4).
One application of the invention, the connecting extension (5) is produced as an extension of the lid (4) during the manufacturing of the lid (4).
One application of the invention, the lens holder (2) is binded mechanically to the lid (4) by the connecting extension (5) in production process. There are nonslip claws(7) on the container(3) and the lid (4) provides not to slip easily from the hand of the user during opening the lid (4). These nonslip rims(7) can be transverse, longitudinal, inclined or curvilinear and in the form of recess or ledge. This shape structure creates an additional friction force during the user holding and opening of lens package(l). Thus, the lid (4) can be opened ergonomically. The leakage of the liquid outside the package and damaging on the lens are preventing by not slipping of the innovative biocompatible lens package from the hand of user.
One application of the invention, the nonslip claws (7) that on the side of the lid(4) are the shape of ledge and lie down parallel through the lids(4) side. The nonslip claws (7) on the side of the container (3) are the shape of recess and lie down parallel through the containers (3) side.
In this lens package(l), at the container' s(3) and the lid's(4) connection surface, there is the line of rupture(6) that is formed during the production process, provides separation of the lid(4) from the container(3) and opening the package(l). This line of rupture(6) can be the area that thermal operation is performed. The line of rupture(6) that can be broken down by user's force , separate the container(3) and the lid(4) easily.
By means of the line of rupture (6), after opening the biocompatible packaging system (1) cannot be closed same as before. This gives the information to the user if the package(l) is opened before or not definitely. During the transportation of lens, for choice the lens holder (2) is attached to the middle of the lid (5) to prevent the lens touching the surface of the biocompatible packaging system (1) and the damages on the lens in quakes. The location of the lens holder (2) gives the information to the user about the location of lens during the opening of lid (5) and taking the lens from the package (1). During the opening, the liquid in the package (1) stay in the container(4) and the lens stay in the lid(5) since that the lens holder (2) is attached to the lid(5). Thus, the package (1) can be opened with no hand touching to the lens and the liquid in it. The environment does not dirty during the opening since he liquid does not leak to the ambient. The damage of the lens while taking of the lens from the biocompatible packaging system (1) is prevented.
In a preferred application of the invention, material that lens package is manufactured from is preferentially medical grade polypropylene, polycarbonate , Polyetherimide or other biocompatible material adapted to the present invention. Mentioned invention biocompatible packaging system is resistant to steam sterilization at 121°C until 30 minutes and 25kGy gamma radiation. One application of the invention, the mechanism of the biocompatible packing system (1) and the lens holder (2) can be changed and the package can be used for transporting another type of lens or medical materials

Claims

CLAIMS innovative biocompatible lens package (1) consists of one biocompatible material, provide to transport the lens in an impermeable and sterile environment in liquid inside package without risk of contamination and characterized by;
At least one holder (2) produced with the biocompatible material, located in the middle of the system preventing the contact of the lens to a surface and preventing damage during transport,
At least one container (3) produced with same biocompatible material, At least a lid (4) connected mechanically to the container (3) produced with the same biocompatible material with container (3),
At least one connecting extension (5) produced with same biocompatible material, extending from the inner surface of the lid (4) to the container (3) enabling the sticking of the lens holder
(2) to the lid due to its recessed structure,
At least one line of rupture (6) produced with same biocompatible material, that provides opening of the lid (4) and gives the information if the lid opened before or not to the user,
At least one nonslip claw (7) produced with same biocompatible material, that is on the container's
(3) and the lid's (4) surface, increase the friction on the surface for not slipping easily from the hand of the user during opening the lid (4),
At least one base (8) produced with same biocompatible material.
The innovative biocompatible lens package (1) according to claim 1, is characterized by the lens holder (2) that has ledges fit the connecting extension's recess part and has at least one body (21).
The innovative biocompatible package (1) according to claim 2, is characterized by the lens holder(2) that has at least two nails (22) provide closing to each other and wrapping the lens in the presence of the pressure.
4. The innovative biocompatible package (1) according to claim 2, is characterized by the lens holder (2) that has a pit in which the lens can be locate, stays the lens stabile in the lens holder (2) and has at least two clamps (23).
5. The innovative biocompatible package (1) according to claim 1, is characterized by recess shaped, ledge shaped, transverse, longitudinal, inclined or curvilinear claw (7).
6. The innovative biocompatible package (1) according to claim 1, is characterized by connecting extension (5) which is an extension of the lid (4)
7. The innovative biocompatible package (1) according to claim 1, is characterized by lens holder (2), body (2.1), claw (2.2), clamp (2.3), container (3), lid (4), connecting extension (5), breaking line (6), nonslip claws (7) and base (8) produced by polypropylene, polycarbonate, polyetherimid or other biocompatible plastic material.
8. The innovative biocompatible package (1) according to claim 1, is characterized by being resistant to steam sterilization at 121°C until 30 minutes and up to 25kGy gamma radiation.
EP16781878.0A 2015-10-27 2016-08-26 An innovative biocompatible packaging system Withdrawn EP3393400A1 (en)

Applications Claiming Priority (2)

Application Number Priority Date Filing Date Title
TR2015/13412A TR201513412A2 (en) 2015-10-27 2015-10-27 AN ADVANCED BIO-ADAPTABLE PACKAGING SYSTEM
PCT/TR2016/050310 WO2017074280A1 (en) 2015-10-27 2016-08-26 An innovative biocompatible packaging system

Publications (1)

Publication Number Publication Date
EP3393400A1 true EP3393400A1 (en) 2018-10-31

Family

ID=57137224

Family Applications (1)

Application Number Title Priority Date Filing Date
EP16781878.0A Withdrawn EP3393400A1 (en) 2015-10-27 2016-08-26 An innovative biocompatible packaging system

Country Status (3)

Country Link
EP (1) EP3393400A1 (en)
TR (1) TR201513412A2 (en)
WO (1) WO2017074280A1 (en)

Families Citing this family (1)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
CN115489797B (en) * 2022-09-27 2023-08-15 漯河有为光电科技有限公司 Anti-fracturing optical lens packaging technology

Family Cites Families (5)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US4423809A (en) * 1982-02-05 1984-01-03 Staar Surgical Company, Inc. Packaging system for intraocular lens structures
US20090057167A1 (en) * 2007-08-30 2009-03-05 Rathert Brian D Intraocular Lens Packaging
WO2011075249A1 (en) * 2009-12-14 2011-06-23 Alcon, Inc. Devices and methods for holding an intraocular lens during the processing and packaging of the intraocular lens
CN201942029U (en) * 2010-09-30 2011-08-24 捷通国际有限公司 Container
NL2010675C2 (en) * 2013-04-19 2014-10-21 Innovalens B V Intraocular lens package and method for packaging an iol.

Also Published As

Publication number Publication date
TR201513412A2 (en) 2017-05-22
WO2017074280A1 (en) 2017-05-04

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