MEDICAL DEVICE AND TREATMENT METHOD

• US 20160120569A1
• Filed: 11/03/2015
• Published: 05/05/2016
• Est. Priority Date: 11/04/2014
• Status: Active Grant

• Current Assignee: Terumo Kabushiki Kaisha
• Original Assignee: Terumo Kabushiki Kaisha
• Inventors: KOBAYASHI, Junichi, HATTA, Tomonori, NAKANO, Taiga
• Granted Patent: US 10,117,669 B2
• Time in Patent Office: Days
• US Class Current: 1/1
• CPC Class Codes: 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
• CPC Class Codes: A61B 17/320725 with radially expandable cutting or abrading elements A61B17/32075 takes precedence
• CPC Class Codes: 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
• CPC Class Codes: A61B 2017/2212 having a closed distal end, e.g. a loop
• CPC Class Codes: A61B 2017/320716 comprising means for preventing embolism by dislodged material
• CPC Class Codes: A61B 2017/320733 with a flexible cutting or scraping element, e.g. with a whip-like distal filament member
• CPC Class Codes: A61B 2017/320741 for stripping the intima or the internal plaque from a blood vessel, e.g. for endarterectomy
• CPC Class Codes: A61B 2017/320775 Morcellators, impeller or propeller like means
• CPC Class Codes: A61B 2090/3904 specially adapted for marking specified tissue
• CPC Class Codes: A61B 2090/3966 Radiopaque markers visible in an X-ray image
• CPC Class Codes: A61B 90/39 Markers, e.g. radio-opaque or breast lesions markers
• CPC Class Codes: A61F 2/013 Distal protection devices, i.e. devices placed distally in combination with another endovascular procedure, e.g. angioplasty or stenting
• CPC Class Codes: A61F 2002/016 made from wire-like elements
• CPC Class Codes: A61F 2002/018 made from tubes or sheets of material, e.g. by etching or laser-cutting

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

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 so as 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 one of 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 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 one of 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, in a state where 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.

2. 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.

3. 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 so as to have a gap between the wires.

4. 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.

5. 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.

6. 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.

7. 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.

8. 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.

9. The treatment method according to claim 1, comprising:

detecting the size of the 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.

10. A treatment method for cutting substances inside a body lumen, the method comprising:

inserting at least one blade of a medical device into the body lumen in a contracted state, the medical device including a tubular drive shaft that is rotatable, a tubular outer sheath that can accommodate the drive shaft, the at least one blade that is rotatably connected to a distal side of the drive shaft, that extends along a rotation axis, and whose central portion is bent so as 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 one of 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;

expanding the at least one blade by moving the linear motion shaft to the drive shaft;

cutting the substances inside the body lumen by causing the drive shaft to rotate the at least one blade; and

supplying the liquid from the liquid supply unit to one of 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, in a state where the medical device is inserted into the body lumen.

11. The treatment method according to claim 10, comprising:

contracting the at least one blade and removing the at least one blade from the inside of the body lumen.

12. The treatment method according to claim 10, comprising:

supporting the at least one blade on a support portion, the support portion configured to be radially inward from the at least one blade, and is formed in a tubular shape by braiding multiple wires so as to have a gap between the wires.

13. The treatment method according to claim 10, comprising:

internally accommodating the at least one blade in the contracted state in the outer sheath; and

exposing the at least one blade to an interior of the body lumen by moving the outer sheath to a proximal side.

14. 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 so as 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 one of a portion between the outer sheath and the drive shaft and a portion between the drive shaft and the linear motion shaft.

15. The medical device according to claim 14, 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.

16. The medical device according to claim 14, wherein the substances are cut inside the body lumen by causing the drive shaft to rotate the at least one strut.

17. The medical device according to claim 14, wherein the liquid from the liquid supply unit is supplied to one of 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, in a state where the medical device is inserted into the body lumen.

18. The medical device according to claim 14, 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.

19. The medical device according to claim 14, 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 so as to have a gap between the wires.

20. The medical device according to claim 14, 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.