JP4954571B2 - Long medical device holding system and method - Google Patents

Description

  The present invention relates to holding a long medical device introduced into the body percutaneously through a tube.

  Angioplasty (PTA: Percutaneous Transluminal Angioplasty, PTCA) is performed to improve the blood flow on the peripheral side of the blood vessel by expanding the stenosis or occlusion site of the blood vessel when stenosis or occlusion occurs in a blood vessel. Percutaneous Transluminal Coronary Angioplasty etc.) have many surgical cases in many medical institutions, and it has become a common operation for this type of case. In addition, stents and the like for maintaining the state of the expanded stenosis have been used in recent years.

  A balloon catheter used for PTA and PTCA is mainly used as a set of a guide catheter and a guide wire in order to expand a stenosis site or a blockage site of a blood vessel. In this angioplasty using a balloon catheter, a guide catheter is first inserted from the femoral artery, the tip is positioned at the entrance of the coronary artery via the aorta, and then the guide wire penetrating the balloon catheter is connected to the stenosis site of the blood vessel or Advancing beyond the occlusion site, then advancing the balloon catheter along the guide wire, inflating the balloon with the balloon positioned at the stenosis site or occlusion site, and expanding the stenosis site or occlusion site; and The balloon is deflated and removed from the body. This balloon catheter is not limited to treatment of a stenosis or occlusion site of a blood vessel, but is useful for many medical applications including insertion into a blood vessel and insertion into various body cavities and tubular tissues.

  However, when the occlusion in the blood vessel is caused by a thrombus, if the occlusion site is expanded with a balloon catheter, the thrombus may be released from the inner wall of the blood vessel and occlude the downstream peripheral blood vessel. In addition, when expanding a stenotic site in a blood vessel, when the lesion contains many rod-shaped plaques, the balloon-caused expansion causes the rod-shaped plaque (atheroma) to scatter from the lesion, causing peripheral blood vessels to It may be blocked. If an embolic material such as a thrombus or atheroma that occludes a peripheral blood vessel occurs in this way, even if the obstruction or stenosis is expanded, blood flow does not flow to the periphery, so slow flow or no flow Fall into the situation.

  In such a situation, it is common to look at the coronary artery until the blood flow is recovered, but there is a problem that it takes time to recover. Depending on the situation, vasodilators may be administered to restore blood flow, or drugs such as thrombolytic agents may be locally administered to dissolve obstructions. There is a problem that it takes time. When peripheral occlusion is severe and hemodynamics are poor, auxiliary means such as IABP (Intra-Aortic Balloon Pumping) is also used.

  In particular, in the case of vascular occlusion or stenosis in the carotid artery or cerebral artery, if peripheral occlusion occurs by performing angioplasty with a balloon catheter or stent, blood flow to the brain stops and the peripheral area of the occluded site is stopped. Brain cells become ischemic. If the ischemic state of the brain continues for a long time, brain cells may die and damage may remain, which may be extremely dangerous. In the case of angioplasty of such cerebral artery or carotid artery, it is compared with other blood vessels Therefore, sufficient care is required so that the peripheral blood vessels are not blocked.

  In order to prevent the peripheral blood vessels from being occluded in this way, it has been attempted to temporarily occlude the peripheral blood vessels of the blood vessels that become the lesion with a balloon and perform angioplasty of the lesioned portion in that state. . Conventionally, a temporary occlusion balloon catheter has been used as a means for temporarily occluding a blood vessel.

  When using a temporary occlusion balloon catheter, it is necessary to suck and remove the embolization-causing substance generated by treatment to the outside of the body using a suction catheter or the like. In order to deliver the suction catheter to the target site, It is necessary to use the shaft as a guide wire and deliver the suction catheter along the shaft to the lesion, or use another guide wire to deliver the suction catheter. When the blood vessel diameter is small, it is very difficult to use another guide wire. On the other hand, when the shaft of the temporary occlusion balloon catheter is used as a guide wire, the lesion is treated with a vascular dilatation balloon catheter or the like, and then the vascular dilatation balloon catheter is replaced with a suction catheter or the like. However, when the vascular dilatation balloon catheter and the aspiration catheter used in the treatment are exchanged, it is necessary to maintain the temporary occlusion balloon catheter in an expanded state, that is, in a pressurized state.

Patent Document 1 discloses a structure in which a seal structure is provided in a proximal end shaft of a temporary occlusion balloon catheter and the temporary occlusion balloon catheter can be maintained in an expanded state for these situations.
Special table 2000-511082 gazette

  However, in the technique disclosed in Patent Document 1, it is necessary to use a seal structure inside the proximal end shaft in order to replace a long medical device such as a balloon catheter or a suction catheter. It tends to be cumbersome and time consuming to treat (including, for example, the time required for balloon expansion / contraction). In addition, since the seal structure is adopted, there is a problem that it is relatively difficult to reduce the diameter of the entire device.

  In view of these situations, the problem to be solved by the present invention is that a long medical device can be quickly and easily held on a guide member without using a mechanism such as a seal structure as described above. It is to provide a catheter system.

The present invention has the following features.
(1) One feature of the present invention is that (a) a long medical device for insertion into a living body lumen and (b) a guide member for guiding insertion into the living body lumen A tubular connecting device provided so as to cover an outer periphery of the elongated medical device in order to hold the medical device in parallel in the axial direction, and (a) the elongated medical device is formed of the guide member. In order to accommodate at least a part, at least one groove portion is provided, and (b) the tubular connecting device has a substantially cylindrical shape having a proximal end and a distal end, and the guide is provided in the axial direction of the tubular connecting device. In order to close the opening on the groove portion after the guide member is accommodated in the groove portion of the long medical device, the tubular connecting device has a slit that allows the member to be inserted. Ri rotatable der circumferentially moving (c) the tubular connection device And / or a fixing means sandwiched in a slit of the tubular connecting device to fix the tubular connecting device and the elongate medical device for temporarily fixing the rotation. A scale medical device holding system.
(2) One feature of the present invention is that, further, (d) the long medical device and the tubular connecting device are connected to prevent the long medical device and the tubular connecting device from separating. It is the elongate medical device holding system characterized by including the connection member which performs.
(3) One feature of the present invention is that (b) the tubular connecting device is made of platinum, palladium, gold, tungsten, tantalum, iridium, stainless steel, cobalt chromium, nitinol, a superelastic alloy and alloys thereof. An elongated medical device holding system comprising a selected metal.
(4) One feature of the present invention is that the (b) tubular connector is made of polyethylene, polyimide, polyamide, polyurethane, polyester, polyolefin, polytetrafluoroethylene, silicon rubber, Teflon (registered trademark), polyamide elastomer, This is a long medical device holding system including a material selected from the group consisting of a polyester-based elastomer, a polyolefin-based elastomer, and a polyurethane-based elastomer.
(5) One of the features of the present invention is that (a) the outer periphery is covered with a tubular connecting device, whereby the guide member for guiding the insertion into the living body lumen is held in parallel in the axial direction. It is a scale medical device.
(6) One feature of the present invention is that (b) the long medical device is held in parallel with the axial direction on the guide member for guiding insertion into the living body lumen. It is a tubular connecting device provided to cover the outer periphery of the tool.
(7) One feature of the present invention is that the elongated medical device is inserted in the living body lumen and the guide member for guiding the insertion into the living body lumen in the axial direction. A long medical device holding method for holding a tubular connecting device provided to cover the outer periphery of the long medical device for holding in parallel, the method being (i) for insertion into a biological lumen Through a slit provided in the axial direction of a tubular connecting device that is provided so as to cover the outer periphery of the long medical device and that is movable in the axial direction on the coaxial line of the long medical device and / or rotatable in the circumferential direction. Inserting a guide member for guiding insertion into a living body lumen; (ii) housing the inserted guide member in a groove provided in the axial direction of the elongated medical device; and (iii) Rotating the tubular connecting device in the circumferential direction, the sleeve A long medical device holding method capable of delivering the long medical device to a target site along the guide member, characterized in that an opening on the groove is closed by moving a tape. is there.

  Other features and advantages of the present invention will become apparent from the following embodiments and drawings.

  According to the long medical device holding system or the long medical device holding method of the present invention, the long medical device can be quickly and easily held on the guide member.

  An embodiment of the present invention will be described below with reference to the drawings.

1. FIG. 1 is an enlarged view of a connecting portion for connecting a catheter 101 (long medical device) and a guide member 102 (guide member) in a catheter system as an embodiment of the “long medical device holding system” of the present invention. It is shown. In the embodiment, the catheter is illustrated as an example of the “long medical device”. However, the catheter is not limited thereto, and other embodiments may use a blood vessel endoscope, a probe for laser therapy, and the like. it can.

  The distal end of the catheter 101 is provided with a groove 103 that allows the guide member 102 to be accommodated, and a tubular connecting device 104 that holds the catheter 101 in the guide member 102. The tubular connecting device 104 has a slit 105 that allows the guide member 102 to be inserted in the axial direction, and is configured to be movable in the axial direction and rotated in the circumferential direction. Further, the catheter 101 includes a fixture 106 as an embodiment of “fixing means” for temporarily fixing the tubular connecting device 104. When the fixture 106 is sandwiched between the slits 105 of the tubular connecting device 104, the tubular connecting device 104 is fixed.

2. Groove part The groove part shape provided in the catheter 101 includes a V-shape and a U-shape, but is not particularly limited as long as the guide member 102 can be accommodated. The groove length is not particularly limited, and may be selected in consideration of the delivery property and flexibility of the catheter 101. Further, in consideration of the sliding property between the catheter 101 and the guide member 102, the groove base end side 107 may be tapered. Further, the number of grooves provided in the catheter 101 is not limited to one as shown in FIG. 1 and may be two or more according to the purpose of use.

3. Regarding the material of the tubular connecting device 104, materials well known to those skilled in the art can be employed, for example, platinum, palladium, gold, tungsten, tantalum, iridium, stainless steel, cobalt chromium, nitinol, superelastic alloys and Metals selected from the group consisting of these alloys, polyethylene, polyimide, polyamide, polyurethane, polyester, polyolefin, polytetrafluoroethylene, silicon rubber, Teflon (registered trademark), polyamide elastomer, polyester elastomer, polyolefin elastomer Alternatively, it can be selected from polyurethane elastomers.

  As for the shape of the tubular connecting device 104, FIG. 1 illustrates a substantially cylindrical shape having a slit 105 that allows the guide member 102 to be inserted in the axial direction. However, the catheter 101 is separated from the guide member 102 during delivery. It is necessary not to easily expand in the radial direction.

Moreover, as another structure of the tubular connecting device 104, for example, as shown in FIG. 2, a configuration in which a plurality of radial cuts 201 are provided (FIG. 2-a), a wave-like structure (FIG. 2-b), and a plurality of window portions Although the structure (FIG. 2-c) provided with 202 can be employ | adopted, it is not limited to these. In each figure of FIG. 2, the upper figure corresponds to a plan view, the lower figure corresponds to a front view, and the left figure corresponds to a left side view.
Flexibility can be improved by making a cut in the tubular connecting device as shown in FIGS. 2-a, b, and c, and delivery to a bent portion is possible.

4). The slit of the tubular connecting device 104 The slit 105 of the tubular connecting device 104 can have various shapes such as a parallel shape, a tapered shape, a shape with a protrusion, etc., but may be selected together with a fixture for temporary fixing. For example, a configuration as shown in FIG. 3 can be selected as the shape of the tubular connecting device and the fixture. In each figure of FIG. 3, the left figure corresponds to a front view, and the right figure corresponds to a right side view.

  FIG. 3A shows a T-shaped fixture 301 attached to the distal end of the catheter. FIG. 3-b shows a substantially triangular fixture 302 attached to the distal end of the catheter. In FIG. 3a, the slit 306 of the tubular connecting device is moved to the fixture side to temporarily fix it. In FIG. 3b, the slit 308 of the tubular coupling device is moved to the fixture side to temporarily fix it.

  FIG. 3C shows a structure in which a projection 303 is provided in the slit 310 of the tubular connecting device, and the fixture has a groove 304 for receiving the projection. As a result, axial movement and circumferential rotation can be temporarily prevented.

  The fixing of the tubular connecting device by the combination of the shape of each fixing device and the shape of each slit of the tubular connecting device corresponds to “fixing means for fixing the tubular connecting device and the elongated medical device”.

5. Other Structures As another structure of the embodiment of the present invention, as shown in FIG. 4, a safety wire 401 as one embodiment of “a connecting member for connecting a long medical device and the tubular connecting device” is provided. The structure which has is employable. Safety wire 401 is attached directly or indirectly to tubular connector 402 and catheter 403. One end of the safety wire is attached to the tubular connector 402, and the other end is directly attached to the catheter 403 as shown in FIG. 4- (a), or the catheter as shown in FIG. 4- (b). It is indirectly attached to a tubular fixture 404 installed on 403.

  As a material of the safety wire 401, for example, a biocompatible metal such as platinum (platinum), tungsten, gold, tantalum, iridium, stainless steel, a superelastic alloy, and an alloy or polymer fiber arbitrarily selected from them may be used. Is possible. In FIG. 4, the wire shape is illustrated as an embodiment of the “connecting member”, but not limited to this, a cord shape, a spring shape, a coil shape, a linear shape, or the like may be adopted. Thus, the catheter can be safely operated without separating the tubular connecting device 402 from the catheter 403.

6). Example of Usage As an example of usage, as shown in FIG. 5, the catheter (or long medical device) is a suction catheter 501 and the “guide member” is a shaft 502 of a temporary occlusion balloon catheter. explain. More specifically, a temporary occlusion balloon catheter having a shaft 502 as a guide member is expanded at the periphery of the lesioned part, and the lesioned part is treated using the vascular dilatation balloon catheter in a state where the blood flow is blocked. In the following description, an operation for fixing the suction catheter 501 to the shaft 502 after drawing the vascular dilatation balloon catheter to the proximal end of the shaft 502 will be described.

  When connecting the catheter 501 and the shaft 502, first, outside the body, the tubular connecting device 503 is circumferentially arranged so that the slit 504 of the tubular connecting device 503 attached to the distal end of the catheter overlaps the groove 505 provided in the catheter. Rotate in the direction to open the groove. Thereafter, the shaft 502 is accommodated in the groove 505 of the catheter 501 through the slit 504 of the tubular connecting device 503 (FIG. 5-a). Next, the tubular connecting device 503 is rotated in the circumferential direction to close the opening on the groove. Further, in order to prevent the tubular connection device 503 from dropping off or rotating, the tubular connection device 503 is moved in the axial direction, and the fixture 506 provided in the catheter is sandwiched in the slit 504 of the tubular connection device 503 so that the tubular connection device 503 is moved. 503 is fixed. (FIG. 5-b).

  After the connection is completed, the catheter 501 is delivered along the shaft 502 to the target site. After the treatment of the lesioned part, the catheter 501 is pulled back out of the body, and the catheter 501 and the shaft 502 are separated by the reverse procedure described above, and the process ends.

  As described above, according to the embodiment, the catheter 501 as one embodiment of the “long medical device” can be quickly inserted without being inserted from the end portion of the shaft 502 as one embodiment of the “guide member”. And it can be easily held on the shaft 502 and the catheter 501 can be delivered to the target site.

  Hereinafter, more specific embodiments according to the present invention will be described in detail.

  When connecting a suction catheter having an outer diameter of 1.5 mm and an inner diameter of 0.9 mm to a temporary occlusion balloon catheter having a main shaft (made of stainless steel coated with Teflon surface) having an outer diameter of 0.35 mm, a width is provided at the distal end of the suction catheter. A groove having a diameter of 0.4 mm and a depth of 0.4 mm was made 15 mm from the tip, and a tubular connecting member having an outer diameter of 1.8 mm and an inner diameter of 1.55 mm having a slit having a width of 0.9 mm on the coaxial outer periphery was disposed. Further, a fixing tool having a width of 1.1 mm was adhered to the tip of the suction catheter on the side opposite to the groove portion to obtain a catheter system as shown in FIG.

FIG. 1 is a schematic diagram for explaining a connection state between a catheter and a guide member as an embodiment of the present invention. FIG. 2 is a schematic diagram of an embodiment of the tubular connecting device according to the present invention. FIG. 3 is a schematic diagram of an embodiment of the fixture according to the present invention. FIG. 4 is a schematic diagram of an embodiment of the safety wire according to the present invention. FIG. 5 is a schematic diagram of one embodiment of the catheter system according to the present invention.

Explanation of symbols

DESCRIPTION OF SYMBOLS 101 Catheter 102 Guide member 103 Groove part 104 Tubular connecting device 105 Slit 106 Fixing tool 107 Groove part proximal end 201 Notch 202 Window part 301 Fixing tool 302 Fixing tool 303 of substantially triangular shape 303 Protrusion part 304 Safety wire 402 Tubular Connecting device 403 Catheter 404 Tubular fixture 501 Suction catheter 502 Temporary occlusion balloon catheter shaft 503 Tubular connecting device 504 Slit 505 Groove 506 Fixing device

Claims (7)

(A) an elongated medical device for insertion into a biological lumen;
(B) Tubular connection provided to cover the outer circumference of the elongated medical device in order to hold the elongated medical device in parallel with the axial direction on the guide member for guiding insertion into the living body lumen Instruments,
Including
(A) the elongate medical device includes at least one groove portion in order to accommodate at least a part of the guide member;
(B) the tubular connector has a substantially cylindrical shape having a proximal end and a distal end, and has a slit that allows insertion of the guide member in the axial direction of the tubular connector;
Wherein (b) a tubular connection device is, after housing the guide member into the groove of the elongate medical device, Ri rotatable der circumferentially to close the opening of the upper the groove,
(C) fixing means sandwiched in a slit of the tubular connecting device in order to fix the tubular connecting device and the elongated medical device for temporarily fixing the movement and / or rotation of the tubular connecting device; ,
An elongate medical device holding system comprising:   The elongated medical device holding system according to claim 1, further comprising:
(D) a connecting member for connecting the elongate medical device and the tubular connecting device in order to prevent the elongate medical device and the tubular connecting device from separating;
An elongate medical device holding system comprising: The (b) tubular coupling device includes a metal selected from the group consisting of platinum, palladium, gold, tungsten, tantalum, iridium, stainless steel, cobalt chromium, nitinol, superelastic alloys, and alloys thereof.
The elongate medical device holding system according to claim 1 or 2.   The (b) tubular connector is made of polyethylene, polyimide, polyamide, polyurethane, polyester, polyolefin, polytetrafluoroethylene, silicon rubber, Teflon (registered trademark), polyamide elastomer, polyester elastomer, polyolefin elastomer and polyurethane elastomer. Comprising a material selected from the group consisting of:
The elongate medical device holding system according to any one of claims 1 to 3. (A) Since the outer periphery is covered with the tubular connecting device, the guide member for guiding the insertion into the living body lumen is held in parallel in the axial direction.
The long medical device according to claim 1 or 2. (B) In order to hold the elongated medical device in parallel to the axial direction on the guide member for guiding the insertion into the living body lumen, it is provided so as to cover the outer periphery of the elongated medical device.
The tubular connecting device according to any one of claims 1 to 4.   A long medical tool for insertion into a living body lumen and a long medical tool for holding the long medical tool in parallel with the axial direction on a guide member for guiding insertion into the living body lumen An elongated medical device holding method for holding together a tubular connecting device provided to cover the outer periphery of a medical device,
(I) Tubular connection provided so as to cover the outer periphery of a long medical device for insertion into a living body lumen and capable of moving in the axial direction and rotating in the circumferential direction on the coaxial line of the long medical device Through a slit provided in the axial direction of the instrument, a guide member for guiding insertion into the living body lumen is inserted,
(Ii) accommodating the inserted guide member in a groove provided in the axial direction of the elongated medical device;
(Iii) rotating the tubular connecting device in the circumferential direction to move the slit to close the opening on the groove;
A long medical device holding method capable of delivering the long medical device to a target site along the guide member.

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