# US 10,245,356 B2 · Medical devices with non-uniform coatings for enhanced echogenicity

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- Number: US 10,245,356 B2
- Document ID: US10245356B2
- Status: Granted
- Kind: B2
- Application number: 15/307,595
- Filed: 2015-04-30
- Published: 2017-02-16
- Granted: 2019-04-02
- Earliest claimed: 2014-04-30
- Assignees: Encapson B.V.
- Applicants: Encapson B.V.
- Inventors: Lee Ayres; David Asrian; Johannes Antonius Opsteen; Dennis Manuel Vriezema
- Web page: https://patentgrep.com/patent/US10245356B2

## CPC

- A61L 31/18: Materials at least partially X-ray or laser opaque
- A61L 29/08: Materials for coatings
- A61L 29/14: Materials characterised by their function or physical properties {, e.g. lubricating compositions}
- A61L 31/08: Materials for coatings
- A61L 31/088: {Other specific inorganic materials not covered by A61L31/084 or A61L31/086}
- A61L 2420/02: Methods for coating medical devices
- A61L: METHODS OR APPARATUS FOR STERILISING MATERIALS OR OBJECTS IN GENERAL; DISINFECTION, STERILISATION OR DEODORISATION OF AIR; CHEMICAL ASPECTS OF BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES; MATERIALS FOR BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES (preservation of bodies or disinfecting characterised by the agents employed A01N; preserving, e.g. sterilising, food or foodstuffs A23; preparations for medical, dental or toiletry purposes A61K)

## Abstract

The invention provides medical devices comprising improved non-uniform coatings for ultrasound detection, which provide optimal ultrasound images. Methods for preparing such devices are also provided.

## Claims

### Claim 1

A medical device comprising a coating for ultrasound detection, said coating comprising microparticles that are visible with ultrasound, wherein the microparticles are solid throughout, wherein the diameter of at least 60% of said microparticles on said medical device is between 10 and 45 μm and the density of said microparticles per surface area is between 45 and 450 particles/mm2, and wherein said coating is applied as a pattern that spatially selectively covers parts of the surface.

### Claim 2 (depends on 1)

The medical device according to claim 1, wherein said particles are essentially spherical.

### Claim 3 (depends on 1)

The medical device according to claim 1, wherein said coating comprises one or more parts with a higher ultrasound visibility than adjacent coated or non-coated parts of the surface of the medical device.

### Claim 4 (depends on 3)

The medical device according to claim 3, wherein said coating part has a contrast to noise (CNR) value that is at least 1.3 times higher than that of said adjacent parts of the surface of the medical device.

### Claim 5 (depends on 1)

The medical device according to claim 1, wherein, in said parts,
the diameter of at least 60% of said microparticles on said medical device is between 22 and 45 μm and the density of said microparticles is between 45 and 450 particles/mm2, or
the diameter of at least 60% of said microparticles on said medical device is between 22 and 27 μm and wherein the density of said microparticles on the surface of said medical device is between 150 and 450 particles/mm2, or
the diameter of at least 60% of said microparticles on said medical device is between 27 and 32 μm and wherein the density of said microparticles on the surface of said medical device is between 70 and 450 particles/mm2, or
the diameter of at least 60% of said microparticles on said medical device is between 32 and 38 μm and wherein the density of said microparticles on the surface of said medical device is between 45 and 225 particles/mm2, or
the diameter of at least 60% of said microparticles on said medical device is between 38 and 45 μm and wherein the density of said microparticles on the surface of said medical device is between 45 and 150 particles/mm2.

### Claim 6 (depends on 1)

The medical device according to claim 1, wherein said microparticles comprise a material selected from the group consisting of polymers, ceramics, glasses, silicates, organic materials, metals and any combination thereof.

### Claim 7 (depends on 1)

The medical device according to claim 1, wherein said coating comprises one or more strips with a width of 1 mm or more with a higher ultrasound visibility than adjacent coated or non-coated parts of the surface of the medical device.

### Claim 8 (depends on 1)

The medical device according to claim 1, wherein the medical device has a tip, and wherein said coating comprises at least two marker bands alternating with uncoated parts of the surface of the medical device, and wherein adjacent marker bands have a different ultrasound visibility.

### Claim 9 (depends on 1)

The medical device according to claim 1, wherein said coating comprises at least a first coated part and second coated part, wherein the average surface density of the microparticles in the first coated part differs from the average surface density of the microparticles in the second coated part.

### Claim 10 (depends on 1)

The medical device according to claim 1, wherein said coating comprises at least a first part and second part, each of said parts having a surface of at least 0.010 mm2, the parts being adjacent to each other or separated by a separator, said separator selected from the group consisting of:
an uncoated part of the surface of the medical device,
a coating part being essentially free of said microparticles, and
a coating part having a contrast-to-noise ratio lower than 1.5,
the first part and the second part being different in at least one of:
the second part having a surface density of said microparticles at least 0.1 times the surface density of said microparticles of the first part,
the microparticles of the first part having a number average particle size at least 1.2 times higher than the microparticles of the second part, and
the second part having a surface density of particles with a diameter between 10 and 45 μm, that is at least 0.1 times higher than the surface density of such particles in the first part, wherein the surface density is expressed in number of particles per mm2 surface of said medical device.

### Claim 11 (depends on 1)

The medical device according to claim 1, wherein in a first coated part and a second coated part one or more of conditions A), B), C), D), and E) applies, provided that the condition for the first coated part is different from the condition for the second coated part, wherein the conditions are selected from the group consisting of:
A) the diameter of at least 60% of said microparticles on said medical device is between 22 and 45 μm and wherein the density of said microparticles on the surface of said medical device is between 45 and 450 particles/mm2,
B) the diameter of at least 60% of said microparticles on said medical device is between 22 and 27 μm and wherein the density of said microparticles on the surface of said medical device is between 150 and 450 particles/mm2,
C) the diameter of at least 60% of said microparticles on said medical device is between 27 and 32 μm and wherein the density of said microparticles on the surface of said medical device is between 70 and 450 particles/mm2,
D) the diameter of at least 60% of said microparticles on said medical device is between 32 and 38 μm and wherein the density of said microparticles on the surface of said medical device is between 50 and 275 particles/mm2, and
E) the diameter of at least 60% of said microparticles on said medical device is between 38 and 45 μm and wherein the density of said microparticles on the surface of said medical device is between 10 and 250 particles/mm2.

### Claim 12 (depends on 10)

The medical device according to claim 10, wherein said first and second part are each a marker band on a curved surface of a shaft of said medical device, separated from each other in the axial direction of said shaft by said separator.

### Claim 13 (depends on 10)

The medical device according to claim 10, wherein the first part has a surface density of particles with a diameter between 10 and 45 μm, that is at least 1.2 times higher than the surface density of such particles in the second part, the surface density in number particles per mm2 surface of said medical device.

### Claim 14 (depends on 1)

The medical device according to claim 1, wherein said particles are essentially spherical.

### Claim 15 (depends on 1)

A method for preparing a medical device according to claim 1, the method comprising:
providing a medical device, and
coating said medical device with a coating comprising microparticles that are visible with ultrasound in a non-uniform way, such that the diameter of at least 60% of said microparticles on said medical device is between 10 and 45 μm and the density of said microparticles on the surface of said medical device is between 45 and 450 particles/mm2.

### Claim 16 (depends on 15)

The method according to claim 15, wherein said medical device is coated with said coating that comprises said microparticles that are visible with ultrasound, such that the diameter of at least 60% of said microparticles on said medical device is between 22 and 45 μm and the density of said microparticles on the surface of said medical device is between 45 and 450 particles/mm2.