# US 12,109,369 B2 · Medical instrument and device having echogenic markings

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- Number: US 12,109,369 B2
- Document ID: US12109369B2
- Status: Granted
- Kind: B2
- Application number: 15/930,619
- Filed: 2020-05-13
- Published: 2020-11-19
- Granted: 2024-10-08
- Earliest claimed: 2019-05-14
- Assignees: Thüringisches Institute für Textile- und Kunstostoff-Forschung e.V.
- Applicants: ThüRingisches Institut FüR Textil—Und Kunststoff—Forschung E.V.
- Inventors: Holger Gunkel
- Web page: https://patentgrep.com/patent/US12109369B2

## CPC

- A61M 25/0045: {multi-layered, e.g. coated (coating materials A61L29/08)}
- A61B 90/39: {Markers, e.g. radio-opaque or breast lesions markers}
- A61L 27/40: Composite materials, i.e. containing one material dispersed in a matrix of the same or different material
- A61M 5/007: {for contrast media}
- A61M 25/0009: {Making of catheters or other medical or surgical tubes}
- A61M 25/0108: {using radio-opaque or ultrasound markers}
- B29C 48/0023: {combined with printing or marking}
- B29C 48/022: {characterised by the choice of material}
- B29C 48/09: Articles with cross-sections having partially or fully enclosed cavities, e.g. pipes or channels
- B29C 48/21: the layers being joined at their surfaces
- A61B 2090/3925: {ultrasonic}
- A61L 2420/08: Coatings comprising two or more layers
- B29K 2075/00: Use of {PU, i.e.} polyureas or polyurethanes {or derivatives thereof}, as moulding material
- B29K 2509/02: Ceramics
- B29L 2031/7542: {Catheters}
- A61M: DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY (introducing media into or onto the bodies of animals A61D7/00; means for inserting tampons A61F13/26; devices for administering food or medicines orally A61J; containers for collecting, storing or administering blood or medical fluids A61J1/05); DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY (surgery A61B; chemical aspects of surgical articles A61L); DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR {(Electrotherapy, e.g. producing anaesthesia by the use of alternating or intermittent currents A61N1/36021)}
- A61B: DIAGNOSIS; SURGERY; IDENTIFICATION (usefulness limited to only animals A61D)
- 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)
- B29C: SHAPING OR JOINING OF PLASTICS; SHAPING OF MATERIAL IN A PLASTIC STATE, NOT OTHERWISE PROVIDED FOR; AFTER-TREATMENT OF THE SHAPED PRODUCTS, e.g. REPAIRING (making preforms B29B11/00; making laminated products by combining previously unconnected layers which become one product whose layers will remain together B32B37/00 - B32B41/00)
- B29K: INDEXING SCHEME ASSOCIATED WITH SUBCLASSES B29B, B29C OR B29D, RELATING TO MOULDING MATERIALS OR TO MATERIALS FOR {MOULDS, } REINFORCEMENTS, FILLERS OR PREFORMED PARTS, e.g. INSERTS
- B29L: INDEXING SCHEME ASSOCIATED WITH SUBCLASS B29C, RELATING TO PARTICULAR ARTICLES

## Abstract

The present invention relates to a medical device having an improved ultrasound visibility and a very smooth surface, to methods for producing the device according to the invention and to the application of the device in therapeutic and diagnostic interventions. The improved ultrasound visibility is achieved by bubbles or closed cavities in an inner polymer layer.

## Claims

### Claim 1

A medical device having an echogenic marking, the device comprising an element having a tubular shape, said element comprising an outer polymer layer and at least one inner polymer layer, and at least the outer polymer layer has a smooth surface,
wherein the outer polymer layer is transparent to laser radiation and at least one inner polymer layer contains laser additives comprised of laser absorbers,
the echogenic marking is comprised of closed cavities or bubbles in the at least one inner polymer layer containing laser additives, with the closed cavities or bubbles having been generated by the laser additives under an action of laser radiation,
the laser absorbers have particle sizes in the range of <300 nm, and
the bubbles or closed cavities have a diameter of 5 to 50 μm and a spherical or partially spherical shape.

### Claim 2 (depends on 1)

The medical device having an echogenic marking according to claim 1, wherein the concentration of the laser absorbers in the at least one inner polymer layer is in the range from 0.05 to 1% by weight.

### Claim 3 (depends on 1)

The medical device having an echogenic marking according to claim 1, wherein the laser absorbers are nanoscale.

### Claim 4 (depends on 2)

The medical device having an echogenic marking according to claim 2, wherein the outer polymer layer has elastic properties sufficient to impart an average roughness value Ra of a region of the surface of the outer polymer layer covering a region of the at least one inner polymer layer comprising the echogenic marking that deviates from a second surface roughness value Ra of a second region of the surface of the outer polymer layer covering a second region of the at least one inner polymer layer not comprising the echogenic marking by not more than 0.2 μm, with said surface roughness values, Ra, measured in accordance with DIN EN ISO 4287:2010.

### Claim 5 (depends on 1)

The medical device having an echogenic marking according to claim 1, wherein the echogenic marking is present in a form of labels, patterns or markings.

### Claim 6 (depends on 1)

The medical device having an echogenic marking according to claim 1, wherein the outer polymer layer has a high transparency to visible light.

### Claim 7 (depends on 1)

The medical device having an echogenic marking according to claim 1, wherein a number of bubbles or closed cavities in the marked areas is between 5 to 200 per mm2.

### Claim 8 (depends on 1)

The medical device having an echogenic marking according to claim 1, wherein the bubbles or closed cavities are gas-filled.

### Claim 9 (depends on 1)

The medical device having an echogenic marking according to claim 1, wherein the device is a catheter, cannula, needle, stent, implant, dilator, balloon or marker.

### Claim 10 (depends on 1)

The medical device having an echogenic marking according to claim 1, wherein said device further comprises an X-ray contrast agent.

### Claim 11 (depends on 1)

A method for producing the medical device having an echogenic marking as claimed in claim 1 comprising
(i) overlaying the inner layer containing laser additive with the outer layer that is transparent to laser radiation or embedding the inner layer containing laser additive between two outer layers;
(ii) foaming areas within the inner layer containing laser additive by treating the tube with laser radiation, thereby causing the laser absorbers to generate closed cavities or vesicles within the inner layer.

### Claim 12 (depends on 11)

The method as claimed in claim 11, wherein said overlaying step is selected from co-extruding, casting, shrink-wrapping, adhering or coating.

### Claim 13 (depends on 11)

The method as claimed in claim 11, wherein said laser radiation has a wavelength of from 350 to 1,100 nm.

### Claim 14 (depends on 11)

The method as claimed in claim 11, wherein the area is a label, pattern or marking.

### Claim 15 (depends on 11)

The method as claimed in claim 11, wherein said method further comprises forming the inner layer by combining nanoscale absorber additives and polymer.

### Claim 16 (depends on 11)

The method as claimed in claim 11, wherein said method further comprises filling one of the layers with an X-ray contrast agent.

### Claim 17 (depends on 1)

The medical device having an echogenic marking according to claim 1, wherein marking visualization is imparted by 10 to 50 closed cavities or bubbles per 1 mm2.

### Claim 18 (depends on 5)

The medical device having an echogenic marking according to claim 5, wherein the pattern or marking is a line or dot.

### Claim 19 (depends on 1)

The medical device having an echogenic marking according to claim 1, wherein the laser additives consist of mixed metal oxides.

### Claim 20 (depends on 19)

The medical device having an echogenic marking according to claim 19, wherein the mixed metal oxide is either indium tin oxide or antimony tin oxide.

### Claim 21 (depends on 1)

A medical device having an echogenic marking according to claim 1, wherein the medical device comprises particles consisting of a single mixed-metal-oxide laser absorber and the outer polymer layer and the inner polymer layer(s) are formed from the same polymer.

### Claim 22 (depends on 4)

A medical device having an echogenic marking according to claim 4, wherein the outer polymer layer has a thickness of less than or equal to 100 μm.

### Claim 23 (depends on 4)

A medical device having an echogenic marking according to claim 4, wherein the outer polymer layer thickness is ⅓ of the inner polymer layer thickness.