JP6055361B2 - Counter electrode and electrical detachable in-vivo indwelling device kit - Google Patents

Description

  The present invention relates to a counter electrode and an electrical detachable in-vivo indwelling device kit.

  Currently, an intravascular treatment method using a catheter or the like is known as a less invasive treatment method for an intravascular lesion such as an aneurysm. For example, as shown in FIG. 8, a technique using an electric detachable coil 120 is known.

  In this procedure, the electrical detachable coil 120 that receives electrical energy from the power source 140 is used in combination with the sheath 133, the guiding catheter 132, and the microcatheter 131, thereby being guided to the aneurysm 160 of the patient 161. Further, the electrical detachable coil 120 causes the indwelling coil 121 to be detached from the pusher 122 by electrical energy and placed in the aneurysm 161 or the like.

  Such an electric detachable coil 120 realizes a smooth movement to a lesion such as an aneurysm 160 and also prevents an excessive load (such as damaging the wall of the aneurysm) from being applied to the lesion. Flexibility is required. As a device for this requirement, for example, it is possible to make the pusher 122 for transporting the indwelling coil 121 as thin as possible.

  Therefore, like the electric detachable coil 120 as shown in FIG. 8 and the electric detachable coil described in Patent Document 1, the pusher 122 that also serves as an electrode that receives electric energy from the power supply 140 has one conductive property. It is desirable that the wire is formed of a conductive wire (such an electric detachable coil is called a monopolar type).

  By the way, in the electric detachable coil 120, an electric circuit serving as a flow path of electric energy (current etc.) must be constructed in order to disconnect the pusher 122 and the detention coil 121. Counter electrode 110 is also required. In the case of the monopolar electric detachable coil 120, as shown in FIG. 8, the counter electrode 110 is often of a type that is affixed to the outside of the body, particularly the patient's back (applied type counter electrode plate).

JP-T-2004-534553

  However, with a patch-type counter electrode, if an electrical detachable coil is required during surgery, the patient must be turned over. It is hard to say that is good.

  In addition, there is a needle type counter electrode plate that is inserted into the patient's groin instead of the affixing type counter electrode plate, but in the case of such a needle, the burden on the patient is large.

  The present invention has been made to solve the above problems. And the objective is to provide the counter electrode etc. which use an electric detachable coil simply, safely, and minimally invasively without turning over a patient in the middle of an operation.

  A counter electrode is provided for an electrical detachable in-vivo indwelling device having a transport device having a single electrode that receives electrical energy from a power source, and an indwelling unit that is detached from the transport device by electrical energy and placed in the living body. used. When using a sheath and a guiding catheter that passes through the lumen of the sheath in combination with the electrically leaving in-vivo indwelling device, the counter electrode extends into the gap between the inner surface of the sheath and the outer surface of the guiding catheter. A conductor exposed from the substrate.

  The conductor preferably includes a thin film electrode piece exposed from one of both ends of the sheath, a connection terminal exposed from the other, and a conductive line extending from the thin film electrode piece to the connection terminal.

  Further, it is desirable that the thin-film electrode piece has a shape along the gap between the inner surface of the sheath and the outer surface of the guiding catheter by bringing the opposing end portions closer to each other.

  The conductor is preferably held by a thin film sheet that enters a gap between the inner surface of the sheath and the outer surface of the guiding catheter.

  In addition, it is desirable that the thin film sheet has a shape along the gap between the inner surface of the sheath and the outer surface of the guiding catheter by bringing the facing end portions closer to each other.

  The thin film sheet is preferably a tube having a slit.

  Moreover, it is desirable that the thin film sheet is formed with a stopper that stops the movement by hitting the edges of both ends of the sheath.

  The stopper is preferably a part of the conductor and serves as at least one of the connection terminal and the conductive line exposed from the other end of the sheath.

  An electrical detachable in vivo indwelling device kit including the above counter electrode and an electrical detachable in vivo indwelling device having a single electrode corresponding to the counter electrode can also be said to be the present invention.

  According to the counter electrode of the present invention, the electric detachable coil can be used in a simple, safe and minimally invasive manner without turning the patient upside down during the operation.

FIG. 2 is a perspective view showing an electric detachable coil and a microcatheter, guiding catheter, sheath, and counter electrode used in combination with the electric detachable coil. FIG. 2 is a cross-sectional view taken along line A-A ′ in FIG. 1, and shows a cross section of an electric detachable coil, a microcatheter, a guiding catheter, a counter electrode, and a sheath that are covered with a sheath. FIG. 2 is a cross-sectional view taken along the line B-B ′ in FIG. 1, showing a cross section of the electrodetachable coil, microcatheter, guiding catheter, and counter electrode exposed from the distal end of the sheath. These are explanatory drawings which show a mode that an electric detachable type coil is used with respect to the patient who suffered from an aneurysm etc. FIG. FIG. 3 is a perspective view showing a counter electrode. These are the electrical circuit diagrams which show the electrical circuit formed when the patient who suffered from an aneurysm etc. is using the electric detachable coil. FIG. 3 is a perspective view showing a counter electrode. These are explanatory drawings which show a mode that the conventional electrical detachment type coil is used with respect to the patient who suffered from an aneurysm etc. FIG.

[Embodiment 1]
The following describes one embodiment with reference to the drawings. For convenience, hatching, member codes, and the like may be omitted, but in such a case, other drawings are referred to. Conversely, for convenience, hatching may be used even if it is not a sectional view. Moreover, the dimension of the various members in drawing may be adjusted so that it may be easy to see for convenience.

  FIG. 1 shows an electric detachable coil [electrically detachable in-vivo device] 20 and a microcatheter 31, a guiding catheter 32, a sheath 33, a power source 40, and a counter electrode used in combination with the electric detachable coil 20. FIG. 2 is a cross-sectional view taken along line A-A ′ in FIG. 1, and FIG. 3 is a cross-sectional view taken along line B-B ′ in FIG. 1.

  FIG. 4 is an explanatory diagram showing a state in which the electric detachable coil 20 is used for a patient 61 suffering from an aneurysm (for example, a cerebral aneurysm 60). FIG. 5 is an enlarged perspective view of the counter electrode 10. A kit including the counter electrode 10 and the electric detachable coil 20 having the electrode coil 24 corresponding to the counter electrode 10 is referred to as an electric detachable coil kit [electrically detachable in vivo indwelling device kit] KT.

  As shown in FIG. 4, the electrical detachable coil 20 uses an electrical energy (current, etc.) from the power source 40 to place a helical indwelling coil [indwelling portion] 21 in a lesion such as an aneurysm 60. It is a medical device to let you.

  The electric detachable coil 20 is inserted into the lumen of the microcatheter 31 to be guided to the entrance of the aneurysm 60, and the microcatheter 31 is inserted into the lumen of the guiding catheter 32. Then, it is guided to approach the aneurysm 60. The guiding catheter 32 is guided into the body by being inserted into the lumen of the sheath 33 inserted into the body from the body surface of the patient 61.

  The power supply 40 supplies a current (for example, a high-frequency current) that is electrical energy to the electrical detachable coil 20. More specifically, the power supply 40 supplies a current to cut off a member (connecting piece 25; described later) that connects the indwelling coil 21 to the electric detachable coil 20 and detaches the indwelling coil 21. The power source 40 is not particularly limited as long as it can supply electric energy sufficient to disconnect the connection piece 25 by melting or electrolysis.

  As shown in FIG. 1, the electrical detachable coil 20 includes, in addition to the indwelling coil 21, a pusher [conveying tool] 22 that conveys the indwelling coil 21, and a connection piece that connects the pusher 22 and the indwelling coil 21. [Connection] 25 is included.

  In the following, in the pusher 22 of the electric detachable coil 20, the side where the indwelling coil 21 is disposed is the distal side, and the opposite side of the distal side is the proximal side. Moreover, when clearly showing the side in each member, it may be called a proximal side and a distal side. In each member, the proximal end is the proximal end, the vicinity of the proximal end is the proximal end, the distal end is the distal end, and the vicinity of the distal end is the distal end. Sometimes.

  The indwelling coil 21 is indwelled in a living body, for example, a lesion such as an aneurysm generated in a blood vessel, and is formed by processing a wire (element wire). The material of the wire is not particularly limited. For example, platinum (platinum), tungsten, gold, tantalum, iridium, titanium, stainless steel, or an alloy formed of a material appropriately selected from these materials may be used. Can be mentioned. Further, the cross-sectional shape of the wire (the cross-sectional shape orthogonal to the full length direction of the wire) is not particularly limited, and examples thereof include a circle, an ellipse, and a polygon.

  Then, the wire is wound around a mandrel or the like and primary processed into a spiral shape or the like (the wire after the primary processing is also referred to as a primary coil), and this primary coil is wound around another mandrel or the like. The indwelling coil 21 is completed by being subjected to secondary processing in a spiral shape or the like (the wire material after the secondary processing is also referred to as a secondary coil) (even if the indwelling coil 21 is completed through the tertiary processing). I do not care).

  The pusher 22 is a wire rod that conveys the indwelling coil 21 and includes, for example, a conductive wire 23 and an electrode coil [electrode (single electrode)] 24 attached to the wire 23 (a wire having the electrode coil 24). 23 may be referred to as an electrode, or the pusher 22 itself may be used as an electrode).

  The wire 23 is a member that occupies most of the pusher 22 and is, for example, a conductive wire material such as a stainless alloy. The pusher 22 is inserted into the lumen of the microcatheter 31 that winds in the body and is advanced by the operator, so that the wire 23 not only has flexibility, but also efficiently applies the operator's force to the distal end. It has high transferability (pushability) to convey to

  The electrode coil 24 is a coil formed of a conductive material like the wire 23, and is attached to the tip (distal end) of the wire 23 (how to attach is not particularly limited). Therefore, for example, when a current flows through the wire 23, a current also flows through the electrode coil 24. Moreover, as long as the electric current supplied to the wire 23 flows, the electrode 24 may be formed in various shapes other than the coil shape.

  The pusher 22 physically connects the electrode coil 24 and the wire 23 to form a single wire and is also electrically connected. Further, the pusher 22 is connected to the terminal 41 {positive terminal (+ terminal) 41A or negative terminal of the power source 40. One of the terminals (-terminal) 41B} is connected via a lead wire 51A or the like. Therefore, the pusher 22 (specifically, the electrode coil 24) including the electrode coil 24 that receives electrical energy from the power supply 40 functions as one electrode (single pole). Therefore, the electric detachable coil 20 including such a pusher 22 is referred to as a monopolar type.

  The connection piece 25 is a connection member that connects the pusher 22 and the indwelling coil 21 and is, for example, a rod such as a solid rod shape or a hollow tube shape. The connection piece 25 is inserted into the lumen of the electrode coil 24 and is inserted into the lumen of the indwelling coil 21, and is fixed to the electrode coil 24 and the indwelling coil 21 with an adhesive or the like.

  The connection piece 25 is formed of a material that is disconnected by the influence of electrical energy such as current. For example, a thermoplastic material such as polyvinyl alcohol can be used. With such a connection piece 25 made of polyvinyl alcohol, it is melted by the electrode coil 24 that generates electric energy and generates heat, and the indwelling coil 21 is separated from the electric detachable coil 20 (that is, the indwelling coil 21 has electric energy). Is removed from the pusher 22 and placed in the living body).

  Here, the counter electrode 10 corresponding to the electrode coil 24 (and thus the pusher 22), that is, the counter electrode 10 which is a conductive member required for forming the electric circuit X (see FIG. 6) for using the electric energy of the power source 40. Will be described.

  In order to form an electric circuit X while preventing a short circuit (short circuit) with the electrode coil 24 (and thus the pusher 22), the counter electrode 10 is disposed between the patient's in-vivo electrolyte 63 ( It is a structure suitable for interposing blood or the like. Such a counter electrode 10 includes a thin film sheet 16 and a conductor 11 that conducts to the electrode coil 24 via blood 63 or the like.

  The thin film sheet 16 is a sheet formed of an insulating material such as polyimide and holds the conductor 11. Then, the thin film sheet 16 has one end of the conductor 11 disposed in the body (blood 63 or the like), while the other end of the conductor 11 is disposed outside the body as shown in FIG. Make it easy to receive energy supply. More specifically, as shown in FIG. 2, the thin film sheet 16 enters the body from outside the body by entering the gap P between the inner surface 33N of the cylindrical sheath 33 and the outer surface 32T of the cylindrical guiding catheter 32. Then, one end of the conductor 11 to be held is disposed inside the body, and the other end is exposed outside the body.

  Therefore, as shown in FIG. 1, the thin film sheet 16 holds at least a part of the thickness of the thin film sheet 16 from the gap P between the inner surface 33N of the sheath 33 and the outer surface 32T of the guiding catheter 32 while holding the conductor 11. Also make it thinner. Furthermore, the thin film sheet 16 has a total length equivalent to or greater than the total length of the sheath 33 (the length from the proximal end to the distal end of the sheath 33).

  The conductor 11 is held by the thin film sheet 16 in a state extending from the distal end portion to the proximal end portion of the thin film sheet 16 (for example, the conductor 11 is along the entire length direction of the thin film sheet 16, The overall length of the sheath 33 is longer than the entire length of the sheath 33). Since the conductor 11 enters the gap P while being held by the thin film sheet 16, the thickness of at least a part of the conductor 11 is also thinner than the gap P.

  In the case of such a counter electrode 10, when the electrically detachable coil 20 is used using the sheath 33 and the guiding catheter 32 that passes through the lumen of the sheath 33, the thin film sheet 16 extends from the distal end of the sheath 33. And the other end of the thin film sheet 16 from the proximal end of the sheath 33 and the other end of the conductor 11 are exposed from the sheath 33. That is, the conductor 11 enters the gap P between the inner surface 33N of the sheath 33 and the outer surface 32T of the guiding catheter 32, exposes one end from the distal end of the sheath 33 inside the body, and is proximal to the sheath 33 outside the body. Expose the other end from one end.

  Therefore, when the other of the terminal 41 {negative terminal (−terminal) 41B or positive terminal (+ terminal) 41A} of the power source 40 is connected to a part of the conductor 11 outside the body via the lead wire 51B, the lead The wire 51A, the pusher 22, the in-vivo electrolyte 63, the counter electrode 10 (specifically, the conductor 11), and the lead wire 51B are electrically connected to form an electric circuit X as shown in FIG. Then, the electric energy flowing through the electric circuit X generates heat in the electrode coil 24, the connecting piece 25 of the pusher 22 is melted and disconnected, and the indwelling coil 21 is detached from the pusher 22.

  The counter electrode 10 required for forming this electric circuit X is, for example, from the opening at the proximal end of the gap P between the sheath 33 inserted in the femoral artery 61F at the base of the foot (groin) and the guiding catheter 32. , Inserted into the gap P. Therefore, the electric detachable coil 20 can be used in a simple, safe and minimally invasive manner without turning the patient 61 upside down during the operation.

  Here, the conductor 11 in the counter electrode 10 will be described in detail with reference to FIG. The conductor 11 is connected to the other of the terminal 41 {the negative terminal (−terminal) 41B or the positive terminal (+ terminal) 41A} in the power supply 40, and includes the connection terminal 12, the thin film electrode piece 13, and the conducting wire 14. .

  The connection terminal 12 is a terminal that is disposed outside the body and is connected to the power supply 40 via the lead wire 51B and the like. The shape of the connection terminal 12 is a ring shape in FIG. 5, but is not particularly limited as long as the lead wire 51B can be easily connected, and may be a sheet shape, a rod shape, or a plate shape. Absent.

  The thin-film electrode piece 13 is an extremely thin film-like electrode that is disposed in the body and can enter into the gap P between the inner surface of the sheath 33 and the outer surface of the guiding catheter 32, for example. More specifically, the thickness of the thin-film electrode piece 13 is a thickness that can pass from the proximal end to the distal end of the gap P while being held by the thin-film sheet 16. The shape of the thin-film electrode piece 13 is not particularly limited as long as it is a shape that can enter the gap P. For example, the shape may be a slice shape or a rod shape.

  The conductive wire 14 is a wire that physically and electrically connects the thin-film electrode piece 13 and the connection terminal 12, and has a total length longer than the total length of the sheath 33. And since this conduction line 14 bridges between the thin film electrode piece 13 and the connection terminal 12, the thin film electrode piece 13, the conduction line 14, and the connection terminal 12 are arranged in a line in this order, and physical Connected in series, and also connected electrically.

  In the conducting wire 14, a portion near the thin-film electrode piece 13 is exposed from the distal end of the sheath 33 and placed inside the body, and a portion near the connection terminal 12 is exposed from the proximal end of the sheath 33 and placed outside the body. . Therefore, a portion of the conducting wire 14 exposed from the distal end of the sheath 33 and a portion remaining inside the sheath 33 is thinner than the gap P (in short, the thickness of at least a part of the conducting wire 14 is the gap P). It is thick enough to penetrate).

  And from such a conductor 11, that is, the thin film electrode piece 13 exposed from the distal end which is one of both ends of the sheath 33, the connection terminal 12 exposed from the proximal end which is the other, and the thin film electrode piece 13 In the case of the conductor 11 including the conductive wire 14 leading to the connection terminal 12, the power source 40 can be easily connected via the connection terminal 12, while the thin-film electrode piece 13 is placed in the body, so Thus, the electric circuit X is reliably formed.

  The shape of the thin-film electrode piece 13 is not particularly limited, but the thin-film electrode piece 13 must pass through the gap P between the inner surface of the sheath 33 and the outer surface of the guiding catheter 32. It is desirable that the end portions to be close to each other have a shape along the gap P.

  For example, as shown in FIG. 2, a gap P between an inner surface 33N of a cylindrical sheath 33 like a cylinder and an outer surface 32T of a cylindrical guiding catheter 32 like a cylinder is annular. In this case, the thin-film electrode piece 13 has an English letter C shape {conductor with a shape along the gap P by bringing the end on one side and the end on the other side close to the full length direction of the conductor 11. 11 is preferably an English letter C shape at an intersection (eg, orthogonal) cross section with respect to the full length direction. If it becomes like this, the thin film electrode piece 13 will pass the clearance gap P easily.

  In addition, the conductor 11 including the thin film electrode piece 13 is easily handled by being held by the thin film sheet 16 that enters the gap P. The thin film sheet 16 that holds the conductor 11 is also easy to handle. The shape along the gap P is desirable by bringing the end on the one side and the end on the other side closer to each other with the full length direction of itself as a boundary.

  For example, when the gap P between the inner surface 33N of the cylindrical sheath 33 and the outer surface 32T of the cylindrical guiding catheter 32 is annular as shown in FIG. , English letter C shape that is the shape along the gap P

  Such a thin film sheet 16 rounded to the letter C shape easily enters the gap P and advances while holding the thin film electrode piece 13. In addition, when the thin film sheet 16 is rounded and formed into a rod shape, it is less likely to bend in its full length direction and in the crossing direction with respect to the full length direction as compared with a simple sheet (in short, the strength is increased) The surgeon's pushing force to the counter electrode 10 is easily transmitted (pushability is improved).

  In addition, the tube may become the thin-film sheet 16 having a cross-sectional English letter C shape by having a slit 17 (see FIG. 5) along the entire length direction of the tube. If it is such a tube 16 (for convenience, the same member number as the thin film sheet 16 is used), the thin film sheet 16 will be manufactured easily.

  The manner of holding the conductor 11 by the thin film sheet 16 is not particularly limited, but one end and the other end of the conductor 11 along the full length direction of the thin film sheet 16 (that is, the full length direction of the conductor 11). If one end and the other end of the thin film sheet 16 are exposed from the thin film sheet 16, the one end is easily disposed inside the body and the other end is disposed outside the body. Then, it is mentioned as an example of the holding | maintenance method that it is embedded so that the conductor 11 may be exposed on the surface of the thin film sheet 16.

[Other embodiments]
The present invention is not limited to the above-described embodiment, and various modifications can be made without departing from the spirit of the present invention.

  For example, the thickness of the thin film sheet 16 of the counter electrode 10 does not need to be constant. The counter electrode 10 enters the clearance P between the inner surface 33N of the cylindrical sheath 33 and the outer surface 32T of the cylindrical guiding catheter 32, and proceeds from the distal end via the proximal end of the clearance P. Only a part comes. Therefore, the thickness of the thin film sheet 16 is only required to be thinner than the gap P only at the portion coming out from the distal end through the proximal end of the gap P.

  The thin film sheet 16 holds the conductor 11. Therefore, for example, if the conductor 11 (particularly, the thin-film electrode piece 13 and the conductive wire 14) is held so as to rise from the surface of the thin-film sheet 16, in the portion of the counter electrode 10 that passes through the gap P, the conductor The maximum thickness of the thin film sheet 16 taking into account the thickness of 11 becomes thinner than the gap P.

  In the above description, the counter electrode 10 has the thin film sheet 16, but is not necessarily essential. For example, as long as the conductor 11 has a strength and a shape that can advance by entering the gap P between the inner surface 33N of the cylindrical sheath 33 and the outer surface 32T of the cylindrical guiding catheter 32, the thin film sheet 16 is unnecessary, and the counter electrode 10 may be formed of only the conductor 11.

  Further, in order to connect the counter electrode 10 to the power source 40, a part of itself must be exposed from the proximal end of the gap P. Therefore, for example, when the thickness of the entire thin film sheet 16 including the thickness of the conductor 11 is thinner than the gap P, the end of the sheath 33 (proximal end) is formed on the surface of the thin film sheet 16 as shown in FIG. The stopper 18 that stops the movement may be formed by hitting the edge of ().

  In addition, instead of such a stopper 18, at least one of the connection terminal 12 and the conductive wire 14 that are a part of the conductor 11 is exposed from the proximal end of the sheath 33 and hits the edge of the proximal end, You may play the role of the stopper which stops the movement of the counter electrode 10. FIG.

DESCRIPTION OF SYMBOLS 10 Counter electrode 11 Conductor 12 Connection terminal 13 Thin film electrode piece 14 Conductive line 16 Thin film sheet 17 Slit 20 Electric separation type coil 21 Indwelling coil 22 Pusher 23 Wire 24 Electrode coil 25 Connection piece 31 Microcatheter 32 Guiding catheter 32T Guiding catheter Outer surface 33 sheath 33N inner surface P of sheath P gap between inner surface of sheath and outer surface of guiding catheter 40 power supply 41 power supply terminal 41A positive (+) terminal of power supply 41B negative (-) terminal of power supply 51A lead wire 51B lead wire X electricity Circuit KT Electric detachable coil kit 60 Aneurysm 61 Patient

Claims (9)

A counter electrode used in an electrical detachable in-vivo indwelling device comprising a transport device having a single electrode that receives electrical energy from a power source, and an indwelling portion that is separated from the transport device by the electrical energy and is placed in the living body. Because
In the case of using the electrical detachable in-vivo in combination with a sheath and a guiding catheter that passes through the lumen of the sheath,
A counter electrode including a conductor that extends while entering a gap between the inner surface of the sheath and the outer surface of the guiding catheter and is exposed from both ends of the sheath.   The counter electrode according to claim 1, wherein the conductor includes a thin film electrode piece exposed from one of both ends of the sheath, a connection terminal exposed from the other, and a conductive wire extending from the thin film electrode piece to the connection terminal.   The counter electrode according to claim 2, wherein the thin film electrode piece has a shape along a gap between the inner surface of the sheath and the outer surface of the guiding catheter by bringing the opposing end portions closer to each other.   The counter electrode according to claim 1, wherein the conductor is held by a thin film sheet that enters a gap between an inner surface of the sheath and an outer surface of the guiding catheter.   The counter electrode according to claim 4, wherein the thin film sheet has a shape along a gap between an inner surface of the sheath and an outer surface of the guiding catheter by bringing opposing end portions closer to each other.   The counter electrode according to claim 5, wherein the thin film sheet is a tube having a slit.   The counter electrode according to any one of claims 4 to 6, wherein a stopper for stopping movement is formed on the thin film sheet by hitting edges of both ends of the sheath.   The counter electrode according to claim 7, wherein the stopper is a part of the conductor and serves also as at least one of a connection terminal and a conductive line exposed from the other of the both ends of the sheath. The counter electrode according to any one of claims 1 to 8,
An electrical detachable in vivo indwelling device having a single electrode corresponding to the counter electrode;
An electrically detachable in-vivo indwelling device kit.