# US 12,178,974 B2 · Guidewire and method of use

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- Number: US 12,178,974 B2
- Document ID: US12178974B2
- Status: Granted
- Kind: B2
- Application number: 17/154,938
- Filed: 2021-01-21
- Published: 2022-07-21
- Granted: 2024-12-31
- Earliest claimed: 2021-01-21
- Assignees: Abbott Cardiovascular Systems Inc.
- Applicants: Abbott Cardiovascular Systems Inc.
- Inventors: Puneet Kamal Singh Gill; Jonathan P. Durcan; Matthew Vasquez
- Web page: https://patentgrep.com/patent/US12178974B2

## CPC

- A61M 25/09: Guide wires
- A61L 31/022: {Metals or alloys}
- A61L 31/088: {Other specific inorganic materials not covered by A61L31/084 or A61L31/086}
- A61L 31/14: Materials characterised by their function or physical properties {, e.g. injectable or lubricating compositions, shape-memory materials, surface modified materials}
- A61L 2420/02: Methods for coating medical devices
- A61M 2025/09075: {having a core without a coil possibly combined with a sheath}
- A61M 2025/09108: {Methods for making a guide wire}
- A61M 2025/09133: {having specific material compositions or coatings; Materials with specific mechanical behaviours, e.g. stiffness, strength to transmit torque}
- A61M 2025/09141: {made of shape memory alloys which take a particular shape at a certain temperature}
- A61M 2025/09158: {when heated}
- A61M 2205/3344: Measuring or controlling pressure at the body treatment site
- 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)}
- 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

A guidewire formed from drawn filled tubing having an inner core member encased in an outer layer. The inner core member is formed from a linear elastic or superelastic material and the outer layer is formed from a metal alloy such as 35N LT. A portion of the outer layer is ground down to form a feather edged joint between the outer layer and the inner core member.

## Claims

### Claim 1

A guidewire, comprising:
an elongated tubular member having a proximal end and distal end;
the elongated tubular member having an inner core member formed from a first metal alloy and an outer layer formed from a second metal alloy surrounding at least a portion of the inner core member; and
a feather edged joint formed only on the outer layer and defining a tapered transition segment between the outer layer and the inner core member wherein the feather edged joint extends radially outwardly along a first constant diameter section of the inner core member.

### Claim 2 (depends on 1)

The guidewire of claim 1, wherein the first metal alloy is formed from a linear elastic alloy or a superelastic alloy.

### Claim 3 (depends on 2)

The guidewire of claim 2, wherein the linear elastic alloy of the first metal alloy is selected from the group of metal alloys consisting of NiTi, CuNiTi and NiTiCr.

### Claim 4 (depends on 3)

The guidewire of claim 3, wherein the second metal alloy is selected from the group of metal alloys consisting of 35N LT, L605, MP35, MP35N, cobalt-chromium, titanium, NiTiCo, NiTiCr, and NiTi ternary alloys.

### Claim 5 (depends on 4)

The guidewire of claim 4, wherein the inner core member is a solid wire.

### Claim 6 (depends on 5)

The guidewire of claim 5, wherein the inner core member has a nominal diameter at an untapered section in the range of 0.0094 inch to 0.029 inch.

### Claim 7 (depends on 6)

The guidewire of claim 6, wherein the outer layer has a nominal transverse single wall thickness at an untapered section in the range of 0.0012 inch to 0.0018 inch.

### Claim 8 (depends on 1)

The guidewire of claim 1, wherein the tapered transition segment of the feather edged joint extends a length along the elongated tubular member beginning at a first point where an average transverse single wall thickness of the outer layer is a constant, and ends at a second point where the average transverse single wall thickness of the outer layer is zero.

### Claim 9 (depends on 8)

The guidewire of claim 8, wherein the outer layer tapers distally from the first point to the second point to form the feather edged joint.

### Claim 10 (depends on 9)

The guidewire of claim 9, wherein the first constant diameter section of the inner core member extends distally from the second point to a third point.

### Claim 11 (depends on 10)

The guidewire of claim 10, wherein the inner core member has a first tapered section extending from the third point to a fourth point.

### Claim 12 (depends on 11)

The guidewire of claim 11, wherein the inner core member has a second constant diameter section extending from the fourth point to a fifth point.

### Claim 13 (depends on 12)

The guidewire of claim 12, wherein the inner core member has a second tapered section extending from the fifth point to a sixth point.

### Claim 14 (depends on 13)

The guidewire of claim 13, wherein the inner core member has a third constant diameter section extending from the sixth point to the distal end of the elongated member.

### Claim 15 (depends on 14)

The guidewire of claim 14, wherein the third constant diameter section has a nominal diameter in the range from 0.002 inch to 0.0060 inch, and the third constant diameter section is less than the first constant diameter section and the second constant diameter section.

### Claim 16 (depends on 15)

The guidewire of claim 15, wherein no portion of the outer layer surrounds the inner core member from the second point to the distal end of the elongated tubular member.

### Claim 17 (depends on 16)

The guidewire of claim 16, wherein the first tapered segment has a length in the range from 2.0 cm to 6.0 cm.

### Claim 18 (depends on 17)

The guidewire of claim 17, wherein the second tapered segment has a length in the range from 2.0 cm to 12.0 cm.

### Claim 19 (depends on 18)

The guidewire of claim 18, wherein an angle of the first tapered segment and the second tapered segment is in the range from 0.1° to 2.0°.

### Claim 20 (depends on 1)

The guidewire of claim 1, wherein the inner core member has a diameter at an untapered section, for a 0.014 inch guidewire, in the range from 0.0094 inch to 0.0125 inch.

### Claim 21 (depends on 1)

The guidewire of claim 1, wherein the inner core member has a diameter at an untapered section, for a 0.018 inch guidewire, in the range from 0.0143 inch to 0.0145 inch.

### Claim 22 (depends on 1)

The guidewire of claim 1, wherein the inner core member has a diameter at an untapered section, for a 0.035 inch guidewire, in the range from 0.0260 inch to 0.0290 inch.

### Claim 23 (depends on 1)

The guidewire of claim 1, wherein a diameter of the inner core member at an untapered section, for a 0.014 inch guidewire, is no more than 93.0% of an overall diameter of the elongated tubular member.

### Claim 24 (depends on 1)

The guidewire of claim 1, wherein a diameter of the inner core member at an untapered section, for a 0.018 inch guidewire, is no more than 82.0% of an overall diameter of the elongated tubular member.

### Claim 25 (depends on 1)

The guidewire of claim 1, wherein a diameter of the inner core member at an untapered section, for a 0.035 inch guidewire, is no more than 91.0% of an overall diameter of the elongated tubular member.

### Claim 26 (depends on 1)

The guidewire of claim 1, wherein the outer layer has a transverse single wall thickness at an untapered section, for a 0.014 inch guidewire, of 0.0012 inch.

### Claim 27 (depends on 1)

The guidewire of claim 1, wherein the outer layer has a transverse single wall thickness at an untapered section, for a 0.018 inch guidewire, of 0.0015 inch.

### Claim 28 (depends on 1)

The guidewire of claim 1, wherein the outer layer has a transverse single wall thickness at an untapered section, for a 0.035 inch guidewire, of 0.0018 inch.

### Claim 29 (depends on 1)

The guidewire of claim 1, wherein a wall thickness of the outer layer at an untapered section, for a 0.014 inch guidewire, is no more than 14.0% of an overall diameter of the elongated tubular member.

### Claim 30 (depends on 1)

The guidewire of claim 1, wherein a wall thickness of the outer layer at an untapered section, for a 0.018 inch guidewire, is no more than 9.0% of an overall diameter of the elongated tubular member.

### Claim 31 (depends on 1)

The guidewire of claim 1, wherein a wall thickness of the outer layer at an untapered section, for a 0.035 inch guidewire, is no more than 4.0% of an overall diameter of the elongated tubular member.

### Claim 32

A guidewire, comprising:
an elongated drawn filled tube having a proximal end and distal end;
the elongated drawn filled tube having an inner core member formed from a first metal alloy and an outer layer formed from a second metal alloy surrounding at least a portion of the inner core member; and
a feather edged joint formed only on the outer layer and defining a tapered transition segment between the outer layer and the inner core member wherein the feather edged joint extends radially outwardly along a first constant diameter section of the inner core member.

### Claim 33 (depends on 32)

The guidewire of claim 32, wherein the first metal alloy is formed from a linear elastic alloy.

### Claim 34 (depends on 33)

The guidewire of claim 33, wherein the linear elastic alloy of the first metal alloy is selected from the group of metal alloys consisting of NiTi, CuNiTi and NiTiCr.

### Claim 35 (depends on 34)

The guidewire of claim 34, wherein the second metal alloy is selected from the group of metal alloys consisting of 35N LT, L605, MP35, MP35N, cobalt-chromium, titanium, NiTiCo, NiTiCr and NiTi ternary alloys.

### Claim 36 (depends on 35)

The guidewire of claim 35, wherein the inner core member is a solid wire.

### Claim 37 (depends on 36)

The guidewire of claim 36, wherein the inner core member has a nominal diameter at an untapered section in the range of 0.0094 inch to 0.029 inch.

### Claim 38 (depends on 37)

The guidewire of claim 37, wherein the outer layer has a nominal transverse single wall thickness at an untapered section in the range of 0.0012 inch to 0.0018 inch.

### Claim 39 (depends on 32)

The guidewire of claim 32, wherein the tapered transition segment of the feather edged joint extends a length along the elongated drawn filled tube beginning at a first point where an average transverse single wall thickness of the outer layer is a constant, and ends at a second point where the average transverse single wall thickness of the outer layer is zero.

### Claim 40 (depends on 39)

The guidewire of claim 39, wherein the outer layer tapers distally from the first point to the second point to form feather edged joint.

### Claim 41 (depends on 40)

The guidewire of claim 40, wherein the first constant diameter section of the inner core member extends distally from the second point to a third point.

### Claim 42 (depends on 41)

The guidewire of claim 41, wherein the inner core member has a first tapered section extending from the third point to a fourth point.

### Claim 43 (depends on 42)

The guidewire of claim 42, wherein the inner core member has a second constant diameter section extending from the fourth point to a fifth point.

### Claim 44 (depends on 43)

The guidewire of claim 43, wherein the inner core member has a second tapered section extending from the fifth point to a sixth point.

### Claim 45 (depends on 44)

The guidewire of claim 44, wherein the inner core member has a third constant diameter section extending from the sixth point to the distal end of the elongated member.

### Claim 46 (depends on 45)

The guidewire of claim 45, wherein the third constant diameter section has a nominal diameter in the range from 0.002 inch to 0.0060 inch, and the third constant diameter section is less than the first constant diameter section and the second constant diameter section.

### Claim 47 (depends on 46)

The guidewire of claim 46, wherein no portion of the outer layer surrounds the inner core member from the second point to the distal end of the elongated tubular member.

### Claim 48 (depends on 47)

The guidewire of claim 47, wherein the first tapered segment has a length in the range from 2.0 cm to 6.0 cm.

### Claim 49 (depends on 48)

The guidewire of claim 48, wherein the second tapered segment has a length in the range from 2.0 cm to 12.0 cm.

### Claim 50 (depends on 49)

The guidewire of claim 49, wherein an angle of the first tapered segment and the second tapered segment is in the range from 0.1° to 2.0°.

### Claim 51 (depends on 32)

The guidewire of claim 32, wherein the inner core member has a diameter at an untapered section, for a 0.014 inch guidewire, in the range from 0.0094 inch to 0.0125 inch.

### Claim 52 (depends on 32)

The guidewire of claim 32, wherein the inner core member has a diameter at an untapered section, for a 0.018 inch guidewire, in the range from 0.0143 inch to 0.0145 inch.

### Claim 53 (depends on 32)

The guidewire of claim 32, wherein the inner core member has a diameter at an untapered section, for a 0.035 inch guidewire, in the range from 0.0260 inch to 0.0290 inch.

### Claim 54 (depends on 32)

The guidewire of claim 32, wherein a diameter of the inner core member at an untapered section, for a 0.014 inch guidewire is no more than 93.0% of an overall diameter of the elongated tubular member.

### Claim 55 (depends on 32)

The guidewire of claim 32, wherein a diameter of the inner core member at an untapered section, for a 0.018 inch guidewire, is no more than 82.0% of an overall diameter of the elongated tubular member.

### Claim 56 (depends on 32)

The guidewire of claim 32, wherein a diameter of the inner core member at an untapered section, for a 0.035 inch guidewire, is no more than 91.0% of an overall diameter of the elongated tubular member.

### Claim 57 (depends on 32)

The guidewire of claim 32, wherein the outer layer has a preferred transverse single wall thickness at an untapered section, for a 0.014 inch guidewire, of 0.0012 inch.

### Claim 58 (depends on 32)

The guidewire of claim 32, wherein the outer layer has a preferred transverse single wall thickness at an untapered section, for a 0.018 inch guidewire, of 0.0015 inch.

### Claim 59 (depends on 32)

The guidewire of claim 32, wherein the outer layer has a preferred transverse single wall thickness at an untapered section, for a 0.035 inch guidewire, of 0.0018 inch.

### Claim 60 (depends on 32)

The guidewire of claim 32, wherein a wall thickness of the outer layer at an untapered section, for a 0.014 inch guidewire, is no more than 14.0% of an overall diameter of the elongated tubular member.

### Claim 61 (depends on 32)

The guidewire of claim 32, wherein a wall thickness of the outer layer at an untapered section, for a 0.018 inch guidewire, is no more than 9.0% of an overall diameter of the elongated tubular member.

### Claim 62 (depends on 32)

The guidewire of claim 32, wherein a wall thickness of the outer layer at an untapered section, for a 0.035 inch guidewire, is no more than 4.0% of an overall diameter of the elongated tubular member.
