MEDICAL DEVICE, COMBINATION OF COATING SOLUTIONS, AND METHOD FOR PRODUCING MEDICAL DEVICE

• US 20140198294A1
• Filed: 08/10/2012
• Published: 07/17/2014
• Est. Priority Date: 08/17/2011
• Status: Active Grant

• Current Assignee: Toray Industries Incorporated
• Original Assignee: Toray Industries Incorporated
• Inventors: Nakamura, Masataka, Kitagawa, Rumiko, Tamiya, Ryuta
• Granted Patent: US 10,591,749 B2
• Time in Patent Office: Days
• US Class Current: 351/159.04
• CPC Class Codes: A61L 2400/10 Materials for lubricating medical devices
• CPC Class Codes: A61L 2420/06 Coatings containing a mixture of two or more compounds
• CPC Class Codes: A61L 2430/16 for reconstruction of eye parts, e.g. intraocular lens, cornea
• CPC Class Codes: A61L 27/18 obtained otherwise than by reactions only involving carbon-to-carbon unsaturated bonds
• CPC Class Codes: A61L 27/34 Macromolecular materials
• CPC Class Codes: A61L 27/50 Materials characterised by their function or physical properties , e.g. injectable or lubricating compositions, shape-memory materials, surface modified materials
• CPC Class Codes: A61L 27/52 Hydrogels or hydrocolloids
• CPC Class Codes: B29D 11/00865 Applying coatings; tinting; colouring printing, marking or copying processes B41M; identification in general G09F3/00; producing decorative effects in general B44C; positioning or marking of lenses B24B13/0055
• CPC Class Codes: C08L 33/00 Compositions of homopolymers or copolymers of compounds having one or more unsaturated aliphatic radicals, each having only one carbon-to-carbon double bond, and only one being terminated by only one carboxyl radical, or of salts, anhydrides, esters, amides, imides or nitriles thereof; Compositions of derivatives of such polymers
• CPC Class Codes: C08L 83/04 Polysiloxanes
• CPC Class Codes: G02B 1/043 Contact lenses
• CPC Class Codes: G02C 7/046 Contact lenses having an iris pattern
• CPC Class Codes: G02C 7/049 Contact lenses having special fitting or structural features achieved by special materials or material structures
• CPC Class Codes: G02C 7/165 with stenopaeic apertures

Abstract

Disclosed is a medical device having an elastic modulus of 100 kPa or more and 2,000 kPa or less, a water content of 10% by mass or less, a tensile elongation of 50% or more and 3,000% or less, and a dynamic contact angle (advancing angle) relative to a borate buffer of 80° or less. The present invention can significantly reduce or avoid a phenomenon of adhesion to a surface when contacted with a surface outside or inside the body, which has hitherto been regarded as a problem in a conventional medical device.

Claims

1. A medical device having:

an elastic modulus of 100 kPa or more and 2,000 kPa or less,

a water content of 10% by mass or less,

a tensile elongation of 50% or more and 3,000% or less, and

a dynamic contact angle (advancing angle) relative to a borate buffer of 80°

or less.

2. The medical device according to claim 1, wherein a surface friction coefficient ratio (Qa) in a state of being wetted with a borate buffer is 2 or less,

provided that Qa=MIUa/MIUo:

where MIUa represents a coefficient of surface friction between the medical device and a smooth quartz glass plate in a state of being wetted with the borate buffer; and

MIUo represents a coefficient of surface friction between “

ACUVUE®

OASYS” and

a smooth quartz glass plate in a state of being wetted with the borate buffer.

3. The medical device according to claim 1, wherein a surface friction coefficient ratio (Qb) in a state of being wetted with a saline is 3 or less,

provided that Qb=MIUb/MIUo:

where MIUb represents a coefficient of surface friction between the medical device and a smooth quartz glass plate in a state of being wetted with the saline; and

MIUo represents a coefficient of surface friction between “

ACUVUE®

OASYS” and

a smooth quartz glass plate in a state of being wetted with the borate buffer.

4. The medical device according to claim 1, wherein a difference (Qb−

Qa) between a surface friction coefficient ratio (Qb) in a state of being wetted with a saline and a surface friction coefficient ratio (Qa) in a state of being wetted with a borate buffer is 1.6 or less,

provided that Qa=MIUa/MIUo, and

Qb=MIUb/MIUo;

where MIUa represents a coefficient of surface friction between the medical device and a smooth quartz glass plate in a state of being wetted with the borate buffer;

MIUb represents a coefficient of surface friction between the medical device and a smooth quartz glass plate in a state of being wetted with the saline; and

MIUo represents a coefficient of surface friction between “

ACUVUE®

OASYS” and

a smooth quartz glass plate in a state of being wetted with the borate buffer.

5. The medical device according to claim 1, wherein the medical device includes a base material, and a layer made of an acidic polymer and a basic polymer is formed on at least a part of a surface of the base material.

6. A method for producing a medical device in which LbL coating is applied to a base material through n steps in total from a first step of bringing a base material into contact with a first solution containing a first polymer to thereby noncovalently apply the first polymer onto the base material to an nth step (n is an integer of 2 or more) of bringing the base material into contact with an nth solution containing an nth polymer to thereby noncovalently apply the nth polymer onto the base material, thus obtaining the medical device, the method comprising:

bringing any one (k−

1)th solution (k is an integer of 2 or more and n or less) of the first solution to the nth solution into contact with a quartz resonator sensor for quartz crystal microbalance (QCM), and quickly washing the quartz resonator sensor with pure water, followed by drying and further the measurement of a resonance frequency using the QCM to obtain a measured value F_k-1,

subsequently bringing a kth solution into contact with this quartz resonator sensor, and quickly washing the quartz resonator sensor with pure water, followed by drying and further the measurement of a resonance frequency using the QCM to obtain a measured value F_k, and

using the (k−

1)th solution and the kth solution in which the F_k−

the F_k-1 is 1,500 or more,

wherein a quartz resonator sensor (resonance frequency of 9 MHz, AT-cut, gold electrode) is used as the quartz resonator sensor, and the measurement is performed at a fundamental frequency of 27 MHz at room temperature (about 25°

C.) using the QCM.

7. A combination of coating solutions for applying LbL coating to a medical device, comprising a first solution to an nth solution,

wherein a coating solution containing a first polymer for noncovalently applying the first polymer onto a base material is used as a first solution, and

a coating solution containing a kth polymer for noncovalently applying the kth polymer onto a base material is used as a kth solution (k is an integer of 2 or more and n or less, n is an integer of 2 or more), and

when a quartz resonator sensor for quartz crystal microbalance (QCM) is immersed in a first solution at 25°

C. for 30 minutes, and then the quartz resonator sensor is quickly washed with pure water and dried, followed by the measurement of a resonance frequency using the QCM to obtain a measured value F₁, and

subsequently, the quartz resonator sensor is immersed in a second solution containing a second polymer at 25°

C. for 30 minutes immersed, and then the quartz resonator sensor is quickly washed with pure water and dried, followed by the measurement of a resonance frequency using the QCM to obtain a measured value F₂, and

the measurement to a measured value F_n was sequentially performed in the same manner,

any one F_k−

F_k-1 becomes 1,500 or more,

wherein a quartz resonator sensor (resonance frequency of 9 MHz, AT-cut, gold electrode) is used as the quartz resonator sensor, and the measurement is performed at a fundamental frequency of 27 MHz at room temperature (about 25°

C.) using the QCM.

8. A low water content soft device for eye to be worn in the eye, having an elastic modulus of 100 kPa or more and 2,000 kPa or less, a water content of 10% by mass or less, a tensile elongation of 50% or more and 3,000% or less, and a dynamic contact angle (advancing angle) relative to a borate buffer of 80°

or less, an iris-like pattern being formed on at least a part of the low water content soft device for eye.

10. The low water content soft device for eye according to claim 8, wherein the pattern is a light shielding pattern having a circular ring shape, and an optical pupil having a diameter of 2.0 mm or less is formed in the center of the pattern.

11. The low water content soft device for eye according to claim 8, wherein the pattern covers a surface of an iris to thereby pseudo-color the iris.

9. A low water content soft device for eye, wherein a layer made of an acidic polymer and a basic polymer is formed on at least a part of the low water content soft device for eye, an iris-like pattern being formed on at least a part of the low water content soft device for eye.

15. The low water content soft device for eye according to claim 9, wherein the pattern is a light shielding pattern having a circular ring shape, and an optical pupil having a diameter of 2.0 mm or less is formed in the center of the pattern.

16. The low water content soft device for eye according to claim 9, wherein the pattern covers a surface of an iris to thereby pseudo-color the iris.

12. A low water content soft contact lens to be worn in the eye, wherein a pattern promoting the exchange of lacrimal fluid between the low water content soft contact lens and the eye is formed.

13. The low water content soft contact lens according to claim 12, wherein the pattern is at least one selected from a through hole, a groove, and a pleats structure.

14. A method for producing a low water content soft contact lens, which comprises molding a base material using a mold made of a resin, and then perforating the base material before separating the base material from the mold made of a resin.