MEDICAL DEVICE AND TREATMENT METHOD

• US 20160120565A1
• 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 10,143,489 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 method 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 drive shaft that is rotatable, 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 support portion that is rotatably driven by the drive shaft, that is formed in a mesh shape and a tubular shape while including multiple gaps, a portion of which is positioned on a radially inner side of the at least one strut, and that is expandable radially outward by a central portion in a direction extending along the rotation axis being bent, a detection unit that detects resistance including at least one of rotating direction resistance and axial direction resistance which act on the at least one strut, the treatment method comprising:

inserting the at least one strut and the support portion which are in a contracted state into the body lumen;

expanding the at least one strut and the support portion;

cutting the substances while repeatedly pushing and pulling the substances inside the body lumen by causing the drive shaft to rotate the at least one strut and the support portion;

causing the detection unit to detect the resistance;

stopping the rotation of the at least one strut and the support portion when the resistance exceeds a preset threshold value or giving a notification that the resistance exceeds the threshold value; and

contracting the at least one strut and the support portion and removing the at least one strut and the support portion from the inside of the body lumen.

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

contracting the at least one strut and the support portion along the axial direction, after the stopping of the rotation of the at least one strut and the support portion or giving the notification that the resistance exceeds the threshold value.

3. The treatment method according to claim 2, wherein in the contracting of the at least one strut and the support portion along the axial direction, the at least one strut and the support portion are separated from the substances by being moved in a proximal direction.

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

moving the at least one strut and the support portion along the axial direction, after the stopping of the rotation of the at least one strut and the support portion or giving the notification that the resistance exceeds the threshold value.

5. The treatment method according to claim 4, wherein in the moving of the at least one strut and the support portion along the axial direction, the at least one strut and the support portion are separated from the substances by being moved in a proximal direction.

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

inserting at least one strut of a medical device into the body lumen in a contracted state, the medical device including a drive shaft that is rotatable, the 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 support portion that is rotatably driven by the drive shaft, that is formed in a mesh shape and a tubular shape while including multiple gaps, a portion of which is positioned on a radially inner side of the at least one strut, and that is expandable radially outward by a central portion in a direction extending along the rotation axis being bent, a detection unit that detects resistance including at least one of rotating direction resistance and axial direction resistance which act on the at least one strut;

expanding the at least one strut and the support portion;

cutting the substances while repeatedly pushing and pulling the substances inside the body lumen by causing the drive shaft to rotate the at least one strut and the support portion;

detecting the resistance of at least one of the rotating direction resistance and the axial direction resistance which act on the at least one strut with the detection unit; and

stopping the rotation of the at least one strut and the support portion when the resistance exceeds a preset threshold value or giving a notification that the resistance exceeds the threshold value.

7. The treatment method according to claim 6, comprising:

contracting the at least one strut and the support portion along the axial direction, after the stopping of the rotation of the at least one strut and the support portion or giving the notification that the resistance exceeds the threshold value.

8. The treatment method according to claim 7, wherein in the contracting of the at least one strut and the support portion along the axial direction, the at least one strut and the support portion are separated from the substances by being moved in a proximal direction.

9. The treatment method according to claim 6, comprising:

moving the at least one strut and the support portion along the axial direction, after the stopping of the rotation of the at least one strut and the support portion or giving the notification that the resistance exceeds the threshold value.

10. The treatment method according to claim 9, wherein in the moving of the at least one strut and the support portion along the axial direction, the at least one strut and the support portion are separated from the substances by being moved in a proximal direction.

11. A medical device for cutting substances inside a body lumen, the medical device comprising:

a drive shaft that is rotatable;

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 support portion that is rotatably driven by the drive shaft, that is formed in a mesh shape and a tubular shape while including multiple gaps, a portion of which is positioned on a radially inner side of the at least one strut, and that is expandable radially outward by a central portion in a direction extending along the rotation axis being bent; and

a detection unit that detects resistance including at least one of rotating direction resistance and axial direction resistance which act on the at least one strut.

12. The medical device according to claim 11, wherein the at least one strut and the support portion are inserted into the body lumen in a contracted state into the body lumen, and the at least one strut and the support portion are expanded so as to be larger than a gap between the substances inside the body lumen.

13. The medical device according to claim 11, wherein the substances are cut by causing the drive shaft to rotate the at least one strut and the support portion so as to be pressed into the gap between the substances.

14. The medical device according to claim 13, wherein the substance are gradually cut by repeatedly pushing and pulling the substances inside the body lumen.

15. The medical device according to claim 11, wherein the detection unit is configured to detect the resistance of at least one of the rotating direction resistance and the axial direction resistance which act on the at least one strut with the detection unit, and the rotation of the at least one strut and the support portion is stopped when the resistance exceeds a preset threshold value or giving a notification that the resistance exceeds the threshold value.

16. The medical device according to claim 15, wherein the at least one strut and the support portion are contracted along the axial direction, after the stopping of the rotation of the at least one strut and the support portion or giving the notification that the resistance exceeds the threshold value.

17. The medical device according to claim 15, comprising:

a notification unit configured to give notification that the resistance exceeds the threshold value.

18. The medical device according to claim 17, wherein the notification unit includes a monitor, which notifies an operator that the resistance exceeds the threshold value.

19. The medical device according to claim 17, wherein the notification unit includes a speaker, which emits a sound when the resistance exceeds the threshold value.

20. The medical device according to claim 11, wherein the at least one strut and the support portion are contracted after cutting the substances in the body lumen such that the at least one strut and the support portion can be removed from the inside of the body lumen.