# US 9,433,746 B2 · Markers for a medical ultrasound imaging catheter

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- Number: US 9,433,746 B2
- Document ID: US9433746B2
- Status: Granted
- Kind: B2
- Application number: 14/608,089
- Filed: 2015-01-28
- Published: 2015-05-28
- Granted: 2016-09-06
- Earliest claimed: 2012-02-08
- Assignees: Siemens Medical Solutions USA, Inc.
- Applicants: Siemens Medical Solutions USA, Inc.
- Inventors: Lex J. Garbini; Wilko Gerwin Wilkening; Ricardo Espinosa
- Web page: https://patentgrep.com/patent/US9433746B2

## CPC

- A61M 25/0012: {with embedded structures, e.g. coils, braids, meshes, strands or radiopaque coils}
- A61B 6/12: Arrangements for detecting or locating foreign bodies
- A61B 6/485: {involving fluorescence X-ray imaging}
- A61B 8/12: in body cavities or body tracts, e.g. by using catheters
- A61B 8/445: {Details of catheter construction}
- A61M 25/0015: {Making lateral openings in a catheter tube, e.g. holes, slits, ports, piercings of guidewire ports; Methods for processing the holes, e.g. smoothing the edges}
- A61M 25/0108: {using radio-opaque or ultrasound markers}
- B23B 47/281: {Jigs for drilling cylindrical parts}
- B29C 66/532: {Joining single elements to the wall of tubular articles, hollow articles or bars}
- A61B 2090/3966: {Radiopaque markers visible in an X-ray image}
- B23B 2270/48: Measuring or detecting
- B29L 2031/7542: {Catheters}
- G01R 33/4814: {MR combined with ultrasound}
- G01S 15/04: Systems determining presence of a target
- Y10T 29/49005: Acoustic transducer
- Y10T 29/49771: Quantitative measuring or gauging
- Y10T 29/49778: with aligning, guiding, or instruction
- Y10T 29/49826: Assembling or joining
- Y10T 29/49895: Associating parts by use of aligning means [e.g., use of a drift pin or a "fixture"]
- Y10T 29/49945: by driven force fit
- Y10T 29/49998: Work holding
- Y10T 29/53087: with signal, scale, illuminator, or optical viewer
- Y10T 29/53091: for work-holder for assembly or disassembly
- Y10T 29/5313: Means to assemble electrical device
- Y10T 29/53961: with work-holder for assembly
- Y10T 408/567: Adjustable, tool-guiding jig
- 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)
- B23B: TURNING; BORING (arrangements for copying or controlling B23Q)
- 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)
- B29L: INDEXING SCHEME ASSOCIATED WITH SUBCLASS B29C, RELATING TO PARTICULAR ARTICLES
- G01R: MEASURING ELECTRIC VARIABLES; MEASURING MAGNETIC VARIABLES (indicating correct tuning of resonant circuits H03J3/12)
- G01S: RADIO DIRECTION-FINDING; RADIO NAVIGATION; DETERMINING DISTANCE OR VELOCITY BY USE OF RADIO WAVES; LOCATING OR PRESENCE-DETECTING BY USE OF THE REFLECTION OR RERADIATION OF RADIO WAVES; ANALOGOUS ARRANGEMENTS USING OTHER WAVES
- Y10T: TECHNICAL SUBJECTS COVERED BY FORMER US CLASSIFICATION

## Abstract

A catheter is provided for medical ultrasound imaging that can be effectively used in combination with other imaging modalities to detect medical structures of interest as well as the catheter. Markers are added to the catheter with precision, which provides a means to merge the images from different modalities. Using a template, apertures for marker placement are formed in the catheter after creating the catheter housing. The ultrasound array may be used for accurate positioning of the template. Alternatively or additionally, a rigid insert with markers connects with the array. The insert holds the markers in place and may reduce artifacts in ultrasound scanning due to flexing of the array.

## Claims

### Claim 1

A method for manufacturing a medical ultrasound imaging catheter, the method comprising:
positioning a formed catheter housing relative to a template, the catheter housing housing an array of ultrasound elements, and the template including at least one first aperture, the positioning being of the first aperture to be near but not on the array;
forming a marker aperture in the catheter housing using the first aperture of the template;
inserting a marker in the marker aperture of the formed catheter housing; and
sealing the marker aperture of the catheter housing around the marker with additional material or material from the formed catheter housing existing prior to the inserting, wherein the sealing is performed after the inserting into the formed catheter housing;
wherein positioning comprises aligning the array relative to the template, and wherein aligning comprises sensing with the array a position of the array relative to the template.

### Claim 2 (depends on 1)

The method of claim 1 wherein the template comprises a cylindrical sleeve, and wherein positioning comprises placing the catheter housing in the cylindrical sleeve.

### Claim 3 (depends on 2)

The method of claim 2 wherein placing comprises sliding the catheter housing into the cylindrical housing until a stop in the cylindrical sleeve prevents further sliding.

### Claim 4 (depends on 1)

The method of claim 1 wherein forming comprises guiding a drill with the first aperture and drilling through the catheter housing.

### Claim 5 (depends on 4)

The method of claim 4 wherein forming comprises zeroing the drill relative to the catheter housing, and wherein drilling comprises drilling to a predetermined depth.

### Claim 6 (depends on 1)

The method of claim 1 wherein inserting comprises removing the template and placing the marker into the marker aperture.

### Claim 7 (depends on 1)

The method of claim 1 wherein sealing comprises heating the catheter housing.

### Claim 8 (depends on 1)

The method of claim 1 wherein the marker comprises a material opaque to x-rays and wherein inserting comprises inserting the material.

### Claim 9 (depends on 1)

The method of claim 1 further comprising:
clamping the catheter housing relative to the template with a compression fitting.

### Claim 10

A method for manufacturing a medical ultrasound imaging catheter, the method comprising:
positioning a catheter housing relative to a template, the catheter housing housing an array of ultrasound elements, and the template including at least one first aperture, the positioning being of the first aperture to be near but not on the array;
forming a marker aperture in the catheter housing using the first aperture of the template;
inserting a marker in the marker aperture; and
sealing the catheter housing around the marker;
wherein positioning comprises:
sensing, by a beamformer and image processor connected with the array, an acoustic target having a different acoustic reflectivity than material of the template supporting the acoustic target, the sensing being of a position of the array relative to the template, the position indicating a first alignment of the array based on a peak in acoustic response received by the beamformer from the array; and
aligning the array relative to the template based on the sensing.

### Claim 11 (depends on 10)

The method of claim 10 wherein the template comprises a cylindrical sleeve, and wherein positioning comprises placing the catheter housing in the cylindrical sleeve.

### Claim 12 (depends on 10)

The method of claim 10 wherein forming comprises guiding a drill with the first aperture, zeroing the drill relative to the catheter housing, and drilling through the catheter housing to a predetermined depth.

### Claim 13 (depends on 10)

The method of claim 10 wherein the marker comprises a material opaque to x-rays, and wherein inserting comprises removing the template and placing the marker into the marker aperture.

### Claim 14 (depends on 10)

The method of claim 10 wherein sealing comprises heating the catheter housing.

### Claim 15 (depends on 10)

The method of claim 10 further comprising:
clamping the catheter housing relative to the template with a compression fitting.

### Claim 16

A method for manufacturing a medical ultrasound imaging catheter, the method comprising:
positioning a catheter housing relative to a template, the catheter housing housing an array of ultrasound elements, and the template including a plurality of guide apertures, the positioning being of the guide apertures to be near but not on the array;
forming marker apertures in the catheter housing using the plurality of guide apertures of the template;
inserting markers in the marker apertures; and
sealing the catheter housing around the markers;
wherein positioning comprises positioning based on measurement by the array of an acoustic response of an acoustic target of the template.

### Claim 17 (depends on 16)

The method of claim 16 wherein forming comprises guiding a drill with one of the plurality of guide apertures, zeroing the drill relative to the catheter housing, and drilling through the catheter housing to a predetermined depth.
