Medical device and treatment method

• US 10,117,670 B2
• Filed: 11/03/2015
• Issued: 11/06/2018
• 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
• Primary Examiner(s): Nguyen, Victor
• Application Number:
  US14/931,623
• Publication Number:
  US 20160120570A1
• Time in Patent Office: 1,099 Days
• 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 with a medical device, the medical device including a drive shaft, at least one strut, and a support portion, the drive shaft configured to be rotatable, the at least one strut configured to be rotatably connected to a distal side of the drive shaft, the at least one strut extending along a rotation axis and having a central portion that is expandable radially outward, and the support portion configured to be rotatably connected to the distal side of the drive shaft, the support portion having a mesh shape and a tubular shape including multiple gaps, at least a portion of the support portion being positioned on a radially inner side of the at least one strut and is expandable radially outward by a central portion in a direction extending along the rotation axis, 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, the expansion of the at least one strut and the support portion causing an outer peripheral surface of the at least one strut to be angled radially inwards towards a rotational direction of the drive shaft;

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

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,

wherein in the expanding of the at least one strut and the support portion, a maximum expansion portion which is most expanded radially outward from the support portion is caused to protrude radially outward further than the at least one strut from a portion between the at least one strut.

3. The treatment method according to claim 2, wherein the at least one strut comprises a plurality of struts.

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

installing a filter portion inside the body lumen before the cutting of the substances inside the body lumen; and

collecting the substance that are cut and dropped off with the filter portion, after the cutting of the substances inside the body lumen.

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

removing the filter portion from the inside of the body lumen.

6. The treatment method according to claim 1, further comprising:

rotating a distal tube together with the drive shaft, the distal tube being arranged on a distal side of the at least one strut, the distal tube having a tubular shape and wherein an outer peripheral surface of the distal tube has multiple convex portions formed on the outer peripheral surface.

7. The treatment method according to claim 1, further comprising:

arranging multiple openings on a distal side of the at least one strut, the multiple openings extending from an outer peripheral surface of the at least one strut to an inner peripheral surface of the at least one strut; and

cutting the substances inside the body lumen with an inner edge of the multiple openings.

8. The treatment method according to claim 1, wherein the at least one strut comprises a plurality of struts, each of the plurality of struts having multiple openings on a distal side of the plurality of struts, the multiple openings extending from an outer peripheral surface of the at least one strut to an inner peripheral surface of the at least one strut, further comprising:

cutting the substances inside the body lumen with an inner edge of the multiple openings.

9. The treatment method according to claim 8, wherein the plurality of struts is four struts, two of the four struts having four openings and two of the four struts having five openings, the four and the five openings extending from an outer peripheral surface of the strut to an inner peripheral surface of the strut, further comprising:

alternately arranging the plurality of struts having four openings and five openings in a circumferential direction.

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

a drive shaft configured to be rotatable;

at least one strut configured to be rotatably connected to a distal side of the drive shaft, that extends along a rotation axis, and whose central portion is configured to be expandable radially outward, and wherein an outer peripheral surface of the at least one strut is configured to be angled radially inwards towards a rotational direction of the drive shaft during rotation of the drive shaft and expansion of the at least one strut; and

a support portion configured to be rotatably connected to the distal side of the drive shaft, the support portion being formed in a mesh shape and a tubular shape including multiple gaps, at least a portion of the support portion being positioned on a radially inner side of the at least one strut, and configured to be expandable radially outward by a central portion in a direction extending along the rotation axis.

11. The medical device according to claim 10, 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 configured to be expanded larger than a gap between the substances inside the body lumen.

12. 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 and pressing the at least one strut and the support portion into the gap between the substances.

13. The medical device according to claim 10, 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.

14. The medical device according to claim 10, wherein in the expanding of the at least one strut and the support portion, a maximum expansion portion which is most expanded radially outward from the support portion is caused to protrude radially outward further than the at least one strut from a portion between the at least one strut.

15. The medical device according to claim 10, comprising:

a filter portion configured to be installed inside the body lumen, before the cutting of the substances inside the body lumen, and the filter portion is configured to collect the substance which are cut and dropped off, after the cutting of the substances inside the body lumen.

16. The medical device according to claim 10, wherein the at least one strut comprises a plurality of struts, each of the plurality of struts having a blade forming a cutting edge.

17. The medical device according to claim 16, wherein each of the plurality of struts has a wide portion whose width in the rotating direction is wider than that of an adjacent portion, and the wide portion has the blade formed therein.

18. The medical device according to claim 10, comprising:

a distal tube on a distal side of the struts, the distal tube having a tubular shape, whose outer peripheral surface has multiple convex portions formed on the outer peripheral surface, and which is rotatable together with the drive shaft.

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

inserting at least one strut on a support portion of a medical device into the body lumen in a contracted state, the medical device including a drive shaft, at least one strut, and a support portion, the drive shaft configured to be rotatable, the at least one strut configured to be rotatably connected to a distal side of the drive shaft, the at least one strut extending along a rotation axis and having a central portion that is expandable radially outward, and the support portion configured to be rotatably connected to the distal side of the drive shaft, the support portion having a mesh shape and a tubular shape, at least a portion of the support portion being positioned on a radially inner side of the at least one strut and is expandable radially outward by a central portion in a direction extending along the rotation axis;

expanding the at least one strut and the support portion, the expansion of the at least one strut and the support portion causing a distal portion of the at least one strut to be located radially outward of the support portion and the central portion of the at least one strut to be located radially inward of the support portion; and

cutting the substances inside the body lumen by causing the drive shaft to rotate the at least one strut and the support portion.

20. The method according to claim 19, wherein the at least one strut has an outer diameter smaller than an outer diameter of the support portion in the expansion state, the method further comprising:

during the expansion of the at least one strut and the support portion, the central portion of the support portion protrudes radially outward between the at least one strut.