TREATMENT DEVICE

• US 20140052104A1
• Filed: 10/25/2013
• Published: 02/20/2014
• Est. Priority Date: 07/25/2011
• Status: Active Grant

• Current Assignee: Terumo Kabushiki Kaisha (Terumo Corporation)
• Original Assignee: Terumo Kabushiki Kaisha (Terumo Corporation)
• Inventors: Kinoshita, Yasushi, Kasukawa, Hiroaki, OSADA, Toshihiko, Yamashita, Keiko
• Granted Patent: US 9,616,202 B2
• Time in Patent Office: Days
• US Class Current: 604/509
• CPC Class Codes: A61M 2025/0183 Rapid exchange or monorail catheters
• CPC Class Codes: A61M 2025/09125 Device for locking a guide wire in a fixed position with respect to the catheter or the human body
• CPC Class Codes: A61M 2025/105 having a balloon suitable for drug delivery, e.g. by using holes for delivery, drug coating or membranes
• CPC Class Codes: A61M 2025/1081 having sheaths or the like for covering the balloon but not forming a permanent part of the balloon, e.g. retractable, dissolvable or tearable sheaths
• CPC Class Codes: A61M 25/1002 characterised by balloon shape A61M25/1006, A61M25/1009 take precedence
• CPC Class Codes: A61M 25/104 used for angioplasty

Abstract

A treatment device includes: a balloon; a biologically active agent part applied on an outer surface of the balloon; a protective sleeve encircling the balloon and being displaceable proximally; and an interposed member having a self-expanding function arranged between the balloon and the protective sleeve. When the protective sleeve is moved proximally in order for the balloon to be exposed to the inside of a blood vessel, the presence of the interposed member prevents the biologically active agent part from being scraped and peeled off by THE inner surface of the protective sleeve.

Claims

1. A treatment device positionable in a blood vessel to treat a stenosed region, the treatment device comprising:

an elongated shaft possessing a distal portion;

an inflatable balloon fixed to the distal portion of the shaft so that the balloon and the shaft move together, the balloon possessing an outer surface and an interior;

a flow path inside the shaft that communicates with the interior of the balloon and through which fluid is introduced into the interior of the balloon to inflate and outwardly expand the balloon;

a restenosis-restraining biologically active agent on the outer surface of the balloon that restrains restenosis, the restenosis-restraining biologically active agent being applied to the stenosed region of the blood vessel when the balloon is inflated and outwardly expanded into contact with the stenosed region;

a protective sleeve covering the entire axial extent of the biologically active agent, the protective sleeve possessing an inner surface and being axially movable in a proximal direction relative to the elongated shaft; and

a cylindrically shaped interposed member positioned radially between the protective sleeve and the restenosis-restraining biologically active agent to space the protective sleeve from the restenosis-restraining biologically active agent and prevent the restenosis-restraining biologically active agent from contacting the protective sleeve, the interposed member possessing a self-expanding function in which the interposed member expands radially outwardly when the protective sleeve is axially moved in the proximal direction relative to the interposed member.

2. The treatment device according to claim 1, wherein the cylindrically shaped interposed member is wound coil.

3. The treatment device according to claim 1, further comprising a linear operating member fixed to the interposed member so that the interposed member moves together with the linear operating member, the linear operating member extending proximally along the shaft at least to a proximal end of the shaft.

4. The treatment device according to claim 3, further comprising a fixing member that detachably fixes the linear operating member relative to the shaft so that the linear operating member is fixed in position relative to the shaft.

5. The treatment device according to claim 4, wherein the fixing mechanism is disposed at a proximal portion of the shaft.

6. The treatment device according to claim 4, wherein the fixing mechanism includes a first clamping part fixed to the shaft and a second clamping part configured to engage and be disengaged from the first clamping part, the linear operating member being fixed relative to the shaft by being clamped between the first clamping part and the second clamping part.

7. The treatment device according to claim 3, wherein the interposed member and the linear operating member are integrally formed so that the interposed member and the linear operating member constitute a common member.

8. The treatment device according to claim 1, further comprising a cylindrical operating member fixed to the interposed member so that the interposed member moves together with the cylindrical operating member, the cylindrical operating member extending proximally beyond a proximal-most end of the protective sleeve.

9. The treatment device according to claim 8, wherein the cylindrical operating member possesses a proximal end connected to a hub so that axial movement of the hub results in axial movement of the cylindrical operating member, the hub being axially movable relative to the shaft.

10. The treatment device according to claim 8, wherein the interposed member and the cylindrical operating member are integrally formed so that the interposed member and the cylindrical operating member constitute a common member.

11. The treatment device according to claim 1, wherein the interposed member possesses an inner surface spaced from the restenosis-restraining biologically active agent so that an annular gap exists between the inner surface of the interposed member and the restenosis-restraining biologically active agent.

12. A treatment device comprising:

a device body having a shaft;

an inflatable balloon disposed at a distal portion of the shaft, the balloon possessing an outer surface;

a biologically active agent part on the outer surface of the balloon and containing at least one biologically active agent;

a protective sleeve covering the biologically active agent part and displaceable proximally in relation to the device body;

an interposed member having a self-expanding function and disposed between the balloon and the protective sleeve in surrounding relation to the balloon and displaceable proximally in relation to the device body; and

the interposed member expanding, while still surrounding the balloon, when the protective sleeve is displaced proximally.

13. The treatment device according to claim 12, further comprising an operating mechanism fixed to a proximal end of the interposed member so that the interposed member moves together with the operating mechanism, the operating mechanism extending along the shaft at least to a proximal end side of the device body, the operating mechanism being configured to inhibit the interposed member from moving proximally relative to the balloon during proximal displacement of the protective sleeve, and the operating mechanism being configured to displace the interposed member proximally upon operation on the proximal end side of the device body.

14. The treatment device according to claim 13, wherein the operating mechanism includes a linear member extending along the shaft.

15. The treatment device according to claim 14, wherein the operating mechanism is detachably fixed to the device body by a fixing mechanism.

16. The treatment device according to claim 15, wherein the fixing mechanism is disposed at a proximal portion of the device body.

17. The treatment device according to claim 16, wherein the fixing mechanism includes a first clamping part on the device body and a second clamping part configured to engage and be disengaged from the first clamping part, and the operating mechanism is fixed by clamping the operating mechanism between the first clamping part and the second clamping part.

18. The treatment device according to claim 13, wherein the interposed member and the operating mechanism are integrally formed so that the interposed member and the operating mechanism constitute a common member.

19. The treatment device according to claim 13, wherein the operating mechanism is a tube extending along the shaft to a proximal portion of the shaft.

20. A method comprising:

Inserting a distal portion of a treatment device into a blood vessel having a lesion part, the treatment device comprising;

a shaft;

an inflatable balloon at a distal portion of the shaft;

a restenosis-restraining biologically active agent on the outer surface of the balloon that restrains restenosis, a protective sleeve covering the restenosis-restraining biologically active agent and possessing an inner surface; and

a self-expanding interposed member between the balloon and the protective sleeve in surrounding relation to the balloon;

forwardly moving the treatment device in the blood vessel to position the balloon at the lesion part;

proximally moving the protective sleeve relative to the interposed member and the balloon while the self-expanding interposed member continues to cover the restenosis-restraining biologically active agent so that the interposed member prevents the restenosis-restraining biologically active agent from contacting the inner surface of the moving protective sleeve, the protective sleeve being proximally moved to expose at least a portion of the interposed member;

proximally moving the interposed member relative to the balloon, after proximally moving the protective sleeve, to expose the balloon and the restenosis-restraining biologically active agent on the balloon; and

inflating the balloon to press the restenosis-restraining biologically active agent on the balloon against the lesion part to dilate the lesion part in the blood vessel and so that the restenosis-restraining biologically active agent adheres to the dilated lesion part.