# US 10,117,669 B2 · Medical device and treatment method

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- Number: US 10,117,669 B2
- Document ID: US10117669B2
- Status: Granted
- Kind: B2
- Application number: 14/931,453
- Filed: 2015-11-03
- Published: 2016-05-05
- Granted: 2018-11-06
- Earliest claimed: 2014-11-04
- Assignees: Terumo Kabushiki Kaisha
- Applicants: Terumo Kabushiki Kaisha
- Inventors: Junichi Kobayashi; Tomonori Hatta; Taiga Nakano
- Web page: https://patentgrep.com/patent/US10117669B2

## CPC

- A61B 17/320758: {with a rotating cutting instrument, e.g. motor driven (A61B17/320725, A61B17/32075 and A61B17/320783 take precedence; for removing intra-ocular material A61F9/00763; endoscopic rotatable cutting instruments A61B17/32002)}
- A61B 17/320725: {with radially expandable cutting or abrading elements (A61B17/32075 takes precedence)}
- A61B 90/39: {Markers, e.g. radio-opaque or breast lesions markers}
- A61F 2/013: {Distal protection devices, i.e. devices placed distally in combination with another endovascular procedure, e.g. angioplasty or stenting}
- A61B 17/221: Gripping devices in the form of loops or baskets {for gripping calculi or similar types of obstructions (surgical snare instruments A61B17/32056)}
- A61B 2017/2212: {having a closed distal end, e.g. a loop}
- A61B 2017/320716: {comprising means for preventing embolism by dislodged material}
- A61B 2017/320733: {with a flexible cutting or scraping element, e.g. with a whip-like distal filament member}
- A61B 2017/320741: {for stripping the intima or the internal plaque from a blood vessel, e.g. for endarterectomy}
- A61B 2017/320775: {Morcellators, impeller or propeller like means}
- A61B 2090/3904: {specially adapted for marking specified tissue}
- A61B 2090/3966: {Radiopaque markers visible in an X-ray image}
- A61F 2002/016: {made from wire-like elements}
- A61F 2002/018: {made from tubes or sheets of material, e.g. by etching or laser-cutting}
- A61B: DIAGNOSIS; SURGERY; IDENTIFICATION (usefulness limited to only animals A61D)
- A61F: FILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS (dental prosthetics A61C)

## Abstract

A treatment medical and medical device are disclosed for cutting a substance inside a body lumen. The medical device includes a drive shaft that is rotatable; a strut that is rotatably connected to a distal side of the drive shaft, that extends along a rotation axis, and whose central portion is expandable radially outward; and a support portion that is rotatably connected to the distal side of the drive shaft, that is formed in a mesh shape and a tubular shape while including multiple gaps, at least a portion of which is positioned on a radially inner side of the strut, and that is expandable radially outward by a central portion in a direction extending along the rotation axis being bent.

## Claims

### Claim 1

A treatment method for cutting substances inside a body lumen by using a medical device including a tubular drive shaft that is rotatable, a tubular outer sheath that can accommodate the drive shaft, at least one strut that is rotatably connected to a distal side of the drive shaft, that extends along a rotation axis, and whose central portion is bent to be expandable radially outward, a linear motion shaft that is arranged inside the drive shaft, and that expands the strut by moving relative to the drive shaft in an axial direction, and a liquid supply unit that supplies liquid to a portion between the outer sheath and the drive shaft and a portion between the drive shaft and the linear motion shaft, the treatment method comprising:
inserting the at least one strut in a contracted state into the body lumen;
expanding the at least one strut by moving the linear motion shaft relative to the drive shaft;
cutting the substances inside the body lumen by causing the drive shaft to rotate the at least one strut;
supplying the liquid from the liquid supply unit to the portion between the outer sheath and the drive shaft and the portion between the drive shaft and the linear motion shaft so that the liquid flows in a distal direction while the medical device is inserted into the body lumen; and
contracting the at least one strut and removing the at least one strut from the inside of the body lumen.

### Claim 2 (depends on 1)

The treatment method according to claim 1, comprising:
detecting an expansion diameter of the at least one strut after expanding the at least one strut and before the cutting of the substances inside the body lumen.

### Claim 3 (depends on 1)

The treatment method according to claim 1, comprising:
supporting the at least one strut on a support portion, the support portion configured to be radially inward from the at least one strut, and is formed in a tubular shape by braiding multiple wires with gaps between the wires.

### Claim 4 (depends on 1)

The treatment method according to claim 1, comprising:
internally accommodating the at least one strut in the contracted state in the outer sheath; and
exposing the at least one strut to an interior of the body lumen by moving the outer sheath to a proximal side.

### Claim 5 (depends on 1)

The treatment method according to claim 1, comprising:
detecting a resistance in an axial direction acting on the drive shaft when the at least one strut is pushed to and pulled from the substances inside the body lumen.

### Claim 6 (depends on 5)

The treatment method according to claim 5, comprising:
calculating the resistance in the axial direction based on a signal received from a sensor in communication with the drive shaft.

### Claim 7 (depends on 5)

The treatment method according to claim 5, comprising:
notifying an operator if the resistance in the axial direction acting on the draft shaft exceeds a predetermined threshold value; and
stopping the rotation of the at least one strut.

### Claim 8 (depends on 1)

The treatment method according to claim 1, comprising:
notifying an operator if a cutting resistance exceeds a predetermined threshold value; and
stopping the rotation of the at least one strut.

### Claim 9 (depends on 1)

The treatment method according to claim 1, comprising:
detecting a size of a gap between the substances using X-ray fluoroscopy to observe a contrast portion having an X-ray contrast material disposed in a portion of the at least one strut.

### Claim 10

A medical device for cutting substances inside a body lumen, the medical device comprising:
a tubular drive shaft that is rotatable;
a tubular outer sheath that can accommodate the drive shaft;
at least one strut that is rotatably connected to a distal side of the drive shaft, that extends along a rotation axis, and whose central portion is bent to be expandable radially outward;
a linear motion shaft that is arranged inside the drive shaft, and that expands the strut by moving relative to the drive shaft in an axial direction; and
a liquid supply unit that supplies liquid to a portion between the outer sheath and the drive shaft and a portion between the drive shaft and the linear motion shaft, and wherein the liquid flows in a distal direction while the medical device is inserted into the body lumen.

### Claim 11 (depends on 10)

The medical device according to claim 10, wherein the at least one strut is inserted in a contracted state into the body lumen, and the at least one strut is expanded by moving the linear motion shaft to the drive shaft.

### Claim 12 (depends on 10)

The medical device according to claim 10, wherein the substances are cut inside the body lumen by causing the drive shaft to rotate the at least one strut.

### Claim 13 (depends on 10)

The medical device according to claim 10, wherein the at least one strut is contracted after cutting the substances in the body lumen such that the at least one strut can be removed from the inside of the body lumen.

### Claim 14 (depends on 10)

The medical device according to claim 10, comprising:
a support portion configured to support the at least one strut, the support portion configured to be radially inward from the at least one strut, and is formed in a tubular shape by braiding multiple wires with gaps between the wires.

### Claim 15 (depends on 10)

The medical device according to claim 10, wherein the at least one strut in the contracted state is internally accommodated in the outer sheath, and the at least one strut is exposed to an interior of the body lumen by moving the outer sheath to a proximal side.

### Claim 16 (depends on 10)

The medical device according to claim 10, further comprising:
an inner tube arranged inside the tubular drive shaft having a lumen; and
wherein the liquid from the liquid supply unit is further supplied to a portion between the inner tube and the tubular drive shaft, and to the lumen of the inner tube.

### Claim 17 (depends on 10)

The medical device according to claim 10, further comprising:
a distal tube fixed to the linear motion shaft distally of the at least one strut, and wherein the inner tube is arranged inside the distal tube; and
wherein the liquid from is discharged from the portion between the drive shaft and the linear motion shaft, the portion between the inner tube and the tubular drive shaft, and the lumen of the inner tube on a distal side of the inner tube.

### Claim 18

A treatment method for cutting substances inside a body lumen by using a medical device including a tubular drive shaft that is rotatable, a tubular outer sheath that can accommodate the drive shaft, an inner tube arranged inside the tubular drive shaft having a lumen, at least one strut that is rotatably connected to a distal side of the drive shaft, that extends along a rotation axis, and whose central portion is bent to be expandable radially outward, a linear motion shaft that is arranged inside the drive shaft, and that expands the strut by moving relative to the drive shaft in an axial direction, and a liquid supply unit that supplies liquid to a portion between the outer sheath and the drive shaft, a portion between the drive shaft and the linear motion shaft, a portion between the inner tube and the tubular drive shaft, and the lumen of the inner tube, the treatment method comprising:
inserting the at least one strut in a contracted state into the body lumen;
expanding the at least one strut by moving the linear motion shaft relative to the drive shaft;
cutting the substances inside the body lumen by causing the drive shaft to rotate the at least one strut; and
supplying the liquid from the liquid supply unit to the portion between the outer sheath and the drive shaft, the portion between the drive shaft and the linear motion shaft, the portion between the inner tube and the tubular drive shaft, and the lumen of the inner tube so that the liquid flows in a distal direction while the medical device is inserted into the body lumen.

### Claim 19 (depends on 18)

The treatment method according to claim 18, further comprising:
fixing a distal tube to the linear motion shaft, the distal tube being distal of the at least one strut;
arranging the inner tube inside the distal tube; and
discharging the liquid from the portion between the drive shaft and the linear motion shaft, the portion between the inner tube and the tubular drive shaft, and the lumen of the inner tube on a distal side of the inner tube.

### Claim 20 (depends on 18)

The treatment method according to claim 18, further comprising:
initially supplying the liquid from the liquid supply to the portion between the outer sheath and the drive shaft;
passing a portion of the liquid from the portion between the outer sheath and the drive shaft through a hole portion of the of the drive shaft into the portion between the drive shaft and the linear motion shaft;
passing a portion of the liquid from the portion between the drive shaft and the linear motion shaft through a hole portion of the linear drive shaft into the portion between the linear drive shaft and the inner tube; and
passing a portion of the liquid from the portion between the linear drive shaft and the inner tube through a hole portion of the inner tube into the lumen of the inner tube.
