JPH0759863A - Catheter with electrode changing asymmetrically - Google Patents

Abstract

PURPOSE: To provide a catheter of which tip can be easily and accurately bent into a desired shape. CONSTITUTION: The electrode assembly has a main support wire bendable in response to force from the outside. When the force from the outside is imparted in the clockwise direction by an operation lever 34, the main support wire is bent in the rightward direction, and forms a nonlinear shape. When the force from outside is imparted in the anticlockwise direction by the operation lever 34, the main support wire is bent in the leftward direction, and forms a nonlinear shape different from the above shape. These nonlinear shapes change variously by changing whether or not plural surfaces of a cam are asymmetric and whether or not two operation wires 56 and 58 connected to the main support wire are connected to each other in an asymmetric shape.

Description

Detailed Description of the Invention

[0001]

FIELD OF THE INVENTION This invention relates generally to catheters, and more particularly to maneuvering and manipulating in internal regions of the body.
It relates to a catheter that can be performed from outside the body.

[0002]

BACKGROUND OF THE INVENTION In today's medical procedure, physicians make extensive use of catheters to access internal regions of the body. It is important for the physician to carefully and accurately control the movement of the catheter within the body.

The need for careful and precise control over the catheter is of particular importance in the procedure of ablating tissue within the heart. Such a procedure, called electrophysiological therapy, is becoming more and more widely used to treat heart rhythm disorders.

During these procedures, the physician inserts a catheter through the vena cava or aorta (typically the femoral artery)
Advance the catheter to the interior region of the heart to be treated.
The physician then further manipulates the steering mechanism so that the electrodes attached to the tip of the catheter are in direct contact with the tissue to be ablated. The doctor ablate tissue by directing radio frequency energy to the tip of the electrode.

[0005]

In particular, the ablation of the heart needs to be performed by accurately positioning the ablation electrode at the ablation position, and for that purpose, it is necessary to bend the tip of the catheter into an accurate shape.

The present invention has been made in order to meet such a demand, and an object thereof is to provide a catheter in which the distal end of the catheter is bent easily and accurately into a desired shape.

[0007]

SUMMARY OF THE INVENTION A catheter according to the present invention comprises a body means bendable in response to external forces applied in different first and second directions, and said first and second body means. And steering means movable to the first and second passages for applying an external force in a second direction, the steering means responsive to the movement to the first passage. To bend the body means in the first direction into a first predetermined non-linear shape and to move the body means in response to movement to the first actuator means and the second passage. A second actuator means for bending in the second direction into a second predetermined non-linear shape different from the first predetermined non-linear shape, whereby the above object is achieved. It

The preferred embodiment further includes a guide tube having a distal end connected to the body means and a proximal end connected to the steering means.

Further, in a preferred embodiment, the main body means includes a flexible wire member including a left side surface and a right side surface, and the steering means is a distant part connected to the left side surface and the right side surface of the wire member, respectively. A left steering wire and a right steering wire having side ends;
Actuator means for pulling the left steering wire to bend the wire member leftward to the first predetermined non-linear shape, and the second actuator means controls the right steering wire. Is pulled to bend the wire member to the right to form the second predetermined non-linear shape. Also, in a preferred embodiment, the connection points of the distal ends of the left steering wire and the right steering wire are generally symmetrical on the left side and the right side of the wire member.

Also, in a preferred embodiment, the connecting points of the distal ends of the left steering wire and the right steering wire are generally asymmetrical on the left side and the right side of the wire member.

In a preferred embodiment, the steering means is a wheel to which the proximal ends of the left steering wire and the right steering wire are connected, and means for rotating the wheel leftward and rightward. , And the first
Actuator means includes a first cam surface on the left side of the wheel that presses and pulls the left steering wire in response to rotation of the wheel to the left, the second actuator means of Includes a second cam surface on the right side of the wheel that pushes and pulls the right steering wire in response to rotation of the wheel to the right and that is different from the first cam surface.

In a preferred embodiment, the first cam surface and the second cam surface are surfaces including curves having different radii.

Further, in a preferred embodiment, one of the first cam surface and the second cam surface is generally linear and the other is generally non-linear.

In a preferred embodiment, the main body includes a wire member having opposite ends and capable of responding to an external force, and the wire member includes:
A hardening means is included to change the hardness of the wire member so that one end thereof has a stronger resistance to bending than the other end.

In a preferred embodiment, a guide tube having a distal end connected to the steering means, and a handling means connected to the base end of the guide tube for holding the steering means. And, are further included.

In a preferred embodiment, the handling means grips the guide tube and rotates the handling means around the axis of the guide tube about its own axis. Includes sleeve means having a coefficient of friction that converts to rotation.

The term "rightward" or "leftward" in the present invention is defined with reference to the longitudinal centerline from the rear end of the catheter toward the front end, and the right side of the centerline is defined as the rightward direction. Good, left side is called left direction. The right surface and the left surface of the member are defined with reference to a center line parallel to the center line of the member, the right surface of the member is referred to as the right surface, and the left surface thereof is referred to as the left surface.

[0018]

The present invention provides a catheter having a distal end bendable in either of two different directions, as selected by the user. The distal end has a predetermined different shape depending on which direction it is bent.

The relationship between the cam radii on the left side of the cam front surface of the cam wheel and the left side of the cam rear surface, the cam radii on the right side of the cam front side of the cam wheel and the right side of the cam rear side, and the left side of the left side of the main support wire The connecting point of the steering wire,
By varying the relationship of the right steering wire's connection point to the right side of the main support wire, the bendable wire forms curves of various shapes.

[0020]

1 illustrates a steerable catheter 10 assembly according to one embodiment of the present invention. As shown, the catheter 10 includes three main parts or assemblies: a handle assembly 12, a guide tube assembly 14, and an electrode assembly 16.

The catheter 10 may be used in numerous environments. In the present specification, the catheter 10
Are used for electrophysiological treatment in the inner region of the heart.

When using the catheter 10 for such purposes, the physician grasps the handle assembly 12 to guide it through the vena cava or aorta (typically the femoral artery) to the interior region of the heart to be treated. Advance tube assembly 14. Subsequently, the physician further manipulates the steering mechanism 18 on the handle assembly 12 to
The electrode assembly 16 is brought into direct contact with the tissue to be excised. The doctor ablates the tissue in contact with the electrode assembly 16 by directing radio frequency energy to the electrode assembly 16.

As best shown in FIGS. 2A and 2B, the handle assembly 12 includes a housing 20 that covers the steering mechanism 18. The steering mechanism 18 includes the housing 2
Rotating cam wheel 22 held by screw 24 in 0
including. The cam wheel 22 rotates by being sandwiched between an upper washer 26 and a lower washer 28. Locking nut 30 and pin 32 connect external steering lever 34 to the top of cam wheel 22. The steering lever 34 is held on the O-ring 36.

When the user operates the control lever 34, the cam wheel 22 rotates around the screw 24 in the housing 20. When the control lever 34 rotates clockwise, the cam wheel 22 rotates to the right, and when the control lever 34 rotates counterclockwise, the cam wheel 2 rotates.
2 rotates to the left. Steering lever 34 and housing 2
Since 0 and 0 are in contact with each other, the range of left-right rotation of the cam wheel 22 inside the housing 20 is limited.

The steering mechanism 18 is also glued to the screw 2
4 includes an outer locking lever 38 glued to the head of the four.
The locking lever 38 is held by another O-ring 36.

The screw 24 is rotated by operating the locking lever 38. When the locking lever 38 rotates clockwise, the screw 24 is retightened and the cam wheel 22
The seating force between the lower washer 28 and the lower washer 28 is increased. When the locking lever 38 is rotated clockwise to the maximum extent and comes into contact with the housing 20, the locking lever 38 applies a seating force that prohibits the steering lever 34 from rotating the cam wheel 22. When the locking lever 38 rotates counterclockwise, the screw 24 loosens, reducing the seating force and thus the cam wheel 2
2 is free to rotate.

The cam wheel 22 has a cam front surface 40 and a cam rear surface 42. The front surface 40 of the cam is the housing 2
0 towards the front with the guide tube assembly 14 attached. The cam front surface 40 includes a right surface 44 and a left surface 4.
Including 6.

The cam rear surface 42 faces the rear portion of the housing 20 to which the coaxial cable 48 is attached.
The cam rear surface 42 includes a right surface 50 and a left surface 52.

The cam wheel 22 also includes a wire fastener 5 between the right side 50 and the left side 52 of the cam rear surface 42.
Holds 4 The wire fastener 54 holds the proximal end of the right steering wire 56 and the proximal end of the left steering wire 58, and both proximal ends are soldered inside the wire fastener 54.

Steering wires 56 and 58 are attached to fastener 5
4 extending forwardly from the end of the cam wheel 22 of FIG.
And extends along the left surfaces 46, 52. Steering wires 56 and 58 emerge from the front of housing 20 through internal holes in tension screw assembly 60.

As will be described in more detail below, steering wire 56
The distal ends of and 58 are connected to the electrode assembly 16. Steering wires 56 and 58 extend from wire fastener 54 through guide tube assembly 14 to electrode assembly 16.

As will be described in more detail below, the wire fasteners 54 cooperate with the cam front surface 40 and the cam rear surface 42 to direct the rotational movement of the cam wheel 22 to the steering wires 56 and 58 coupled to the electrode assembly 16. It is converted into a horizontal pulling motion of.

When the cam wheel 22 is rotated counterclockwise by rotating the steering lever 34 counterclockwise, the left steering wire 58 is pressed against the left surface 46 of the cam front surface 40 and the left surface 52 of the cam rear surface 42. It The left surfaces 46 and 52 of the cam wheel 22 are connected to the left steering wire 58.
The tension is applied to the electrode assembly 16 so as to bend the electrode assembly 16 to the left, thereby providing a discontinuous and constant tensile force.

When the cam wheel 22 is rotated to the right by rotating the steering lever 34 in the clockwise direction, the right steering wire 56 moves the right steering wire 56 to the right surface 44 of the cam front surface 40.
And the right surface 50 of the cam rear surface 42. The right sides 44 and 50 of the cam wheel 22 are the right steering wire 5
Applying tension to 6 imparts a discontinuous and constant tensile force that bends the electrode assembly 16 to the right.

Further rotation of the pull screw assembly 60 causes the wire fastener 54 and steering wires 56 and 5 to rotate.
The amount of looseness (eg, pulling) of the steering wires 56 and 58 changes between the distal end of the steering wire 56 and the distal end of the steering wire 8. This allows the electrode assembly 1 to respond to the rotation of the cam wheel 22.
A responsiveness of 6 is controlled.

The parts of the handle assembly 12 may be constructed of various materials depending on the durability desired and the sterilization process used.

For example, if EtO sterilization is used, the housing 20 and lower washer 28 may be formed of polycarbonate material. In this case, the cam wheel 22, the steering lever 34, and the locking lever 38
Can be formed of Delrin material. These plastic materials are durable and can be EtO sterilized.
In this assembly, locking nut 30, pin 32, and screw 24 are preferably formed of a metallic material such as brass or stainless steel.

As shown in FIG. 3, the guide tube assembly 14
Includes a flexible shaft 62 coupled to the handle assembly 12. The shaft 62 has an internal hole 64. The steering wires 56 and 58 are inserted through the inner hole 64.

The shaft 62 can be formed in various ways. In the embodiment shown in FIG. 3, the shaft 62 is constructed by winding a long stainless steel into a coil having an internal hole 64 to provide a flexible spring-like shape. A blade sheath 66 formed of a plastic material covers the coiled shaft 62.

Further, in the embodiment shown in FIG. 4, the shaft 62 is made of a stainless steel pipe having an internal hole 64 and a slot 70. The row of slots 70 determines the length of the tube. Slot 70
Are formed on the circumferential surface of the shaft 62 over an angle of between 270 ° and 300 °. The slots 70 are also offset from each other by 30 ° to 120 °.

Shaft 62 with slot 70 shown in FIG.
Provides strength and flexibility along the length of the guide tube assembly 14. The slotted shaft 62 is also more direct than the coiled shaft 62 shown in FIG.
The twist (torque) from the handle assembly 12 is transmitted to the electrode assembly 16. For more details on slotted shafts, see Lundquist, February 15, 1991, "Torq.
Uable Catheter and Method "is described in pending US patent application Ser. No. 07 / 657,106.

As with the coiled shaft 62 shown in FIG. 3, a sheath 66 covers the shaft 62 with slots 70. The sheath 66 is formed of a plastic material such as polyolefin.

The handle assembly 12 includes a tubular stem portion 74 through which the proximal end of the guide tube assembly 14 passes and is coupled to the tension screw assembly 60. The proximal end of coiled shaft 62 is attached to tension screw assembly 60 by an adhesive.

The guide tube assembly 14 can be formed in various lengths. In the illustrated embodiment, the guide tube assembly 14 is about 100 cm long.

As shown in FIGS. 1 and 2A and 2B, the sleeve 76 connects the guide tube assembly 14 to the handle assembly 12. One end of the sleeve 76 is fixed to the stem portion 74 of the handle assembly 12 with an adhesive. The sleeve 76 has a handle assembly 12
From the stem portion 74 of the guide tube assembly 14 to the sheath 66 of the guide tube assembly 14.
Has an inner bore that tapers in the direction so that the sleeve 76 is tightly engaged about the sheath 66. The exterior of the sleeve 76 is also tapered and extends about 4 to 5 inches beyond the front of the housing 20 of the handle assembly 12.

The sleeve 76 is made of a material having a high coefficient of friction such as Kraton G2703. The sleeve 76 has a gripping surface that assists the user in manipulating the catheter 10. The sleeve 76 also
When used with a slotted tube, it greatly improves the transfer of torque from the handle assembly 12 through the guide tube assembly 14 to the electrode assembly 16.

The electrode assembly 16 includes a bendable main support wire 78 having a left side 78L and a right side 78R. In the illustrated embodiment, the main support wire 78
Is formed from stainless steel flat wire stock having an elongated shape with a width of about 0.035 inches and a thickness of about 0.005 inches. The main support wire 78 is about 3 inches long.

Both ends of the main support wire 78 are cut to form stepped shoulders 80 and 82. In the illustrated embodiment, shoulders 80 and 8
2 is approximately 0.024 inches wide and is aligned along the centerline of the main support wire 78. Each shoulder 80 and 82 is approximately 0.12 inches long.

As shown in FIG. 3, one shoulder 80 fits over the distal end of the flexible shaft 62, thereby connecting the electrode assembly 16 to the guide tube assembly 14. When the main support wire 78 is properly oriented, the left surface 78L and the right surface 78R of the main support wire 78 lie in a plane generally parallel to the axis of rotation of the cam wheel 22. In other words, when the user holds the handle assembly 12 on a horizontal surface, the left side 78L and right side 78R of the main support wire 78 are on the vertical side.

The distal end of the left steering wire 58 is soldered to the left surface 78L of the main support wire 78. The left steering wire 58 bends the main support wire 78 to the left when pulled by the left rotation of the cam wheel 22.

The far end of the right steering wire 56 is soldered to the right surface 78R of the main support wire 78. The right steering wire 56, when pulled by the right rotation of the cam wheel 22, pulls the main support wire 78.
Bend to the right.

In the illustrated embodiment, the stiffness of the primary support wire 78 is not uniform and varies along its length. The stiffest portion is the proximal region, where the main support wire 78 is connected to the shaft 62.
The lowest stiffness is the tip 88 of the shoulder 82.
By varying the stiffness of the main support wire 78 between the proximal end and the distal end distal end 88, the proximal end of the electrode assembly 16 (the connection with the guide tube assembly 14) bends. And resist bending. The bending force generated by the steering wires 56 and 58 is directed to the distal end of the main support wire 78. Due to the positional change of the rigidity of the main support wire 78, the bending force is
Concentrate on the distal end 88 of the distal end of the electrode assembly 16.

There are various ways to vary the stiffness of the main support wire 78 along its length. One method, not shown, is to change the thickness of the main support wire 78 as it is manufactured. This allows the main support wire 7
8 is thickest (ie, stiffest) at the shoulder 80 that fits within the shaft 62 in use.

In the preferred embodiment shown in FIG. 5, the strengthening spring assembly 90 strengthens the central support near the distal end of the shaft 62. The strengthening spring assembly 90 includes two leaf springs 92 that sandwich the main support wire 78. Each leaf spring 92 has a width of about 0.039 inches and a thickness of about 0.039.
It is formed from a 029 inch stainless steel flat wire stock.

The strengthening spring assembly 90 provides the desired stiffness and amount of variation. In the illustrated embodiment, the strengthening spring assembly 90 reinforces the portion of the main support wire 78 approximately 1.5 inches from a location approximately 0.030 inches to 0.050 inches from the inner end of the shoulder 80.

In the illustrated embodiment, the leaf spring 92
Are secured to the main support wire 78 by spot welds 94. The three spot welds 94 shown are concentrated near the proximal end of the spring strengthening assembly 90. Here, the spot welds 94 are equidistant from one another, with the farthest spot welds 94 being about 0.10 inches from the proximal end of the strengthening spring assembly 90.

In the illustrated embodiment, the distal end of electrode assembly 16 includes a cutting tip electrode 96 and three ring electrodes 98. An inner conductive wire 100 is connected to the tip electrode 96 and the three ring electrodes 98. The conductive wire 100 extends along the main support wire 78 through the inner bore of the shaft 62, passes through the housing 20 of the handle assembly 12 and is connected to a coaxial cable 48 extending from the rear of the housing 20. There is.

At the end of the coaxial cable 48, the plug 10
2 is attached. A suitable conventional catheter control device (not shown) is connected to the plug 102. The conductive wire 100 carries current from the ring electrode 98 that directs electrical activity within the heart. Conductive wire 10
0 also carries out the ablation process in the heart by transmitting radio frequency energy to the tip electrode 96.

Electrode assembly 16 and guide tube assembly 1
There are various methods of guaranteeing the connection with 4. In the illustrated embodiment, the stiffening sleeve assembly 104 is employed for this purpose.

As shown in FIGS. 6A-6D, the reinforced sleeve assembly 104 is formed in association with a specially designed sleeve mandrel 106. In the illustrated embodiment, the sleeve mandrel 106 is made of stainless steel and has a total length of about 7 inches.
As shown in FIG. 6A, the sleeve mandrel 106
Is a cylindrical first main body portion 108 and the first main body portion 1
Cylindrical second body 1 having a diameter greater than 08
Including 10. In the illustrated embodiment, the first body portion 108 is about 0.032 inches in diameter and about 5 inches long. The second body 110 has a diameter of about 0.043 inches and a length of about 2 inches. First body 108
And the second body 110 has notches 112 that each slope inwardly.

The reinforcing sleeve assembly 104 shown in FIG. 6A is formed as follows. The sleeve mandrel 106 is inserted into the first heat shrink tube 114. The first heat shrink tubing 114 is about 4.5 inches long in the illustrated embodiment. The second main body 110 of the sleeve mandrel 106 is inserted into a part of the first heat-shrinkable tube 114. Heating with an oven or heat gun causes the first heat-shrinkable tube 114 to shrink at the proper location on the sleeve mandrel 106.

Next, as shown in FIG. 6B, the reinforcing fiber 116 is wound around the first heat-shrinkable tube 114 on the sleeve mandrel 106 in a tensioned state. Reinforcing fiber 1
The 16 is wrapped in a single spiral to obtain the desired tight pitch. In the illustrated embodiment, the reinforcing fibers 116 are wrapped about 18-20 turns per inch. During this manufacturing process, the notches 112 on the sleeve mandrel 106 hold the reinforcing fibers 116 in tension.

Next, as shown in FIGS. 6B and 6C, the reinforcing fiber 11 is placed on the sleeve mandrel 106.
The first heat-shrinkable tube 114 wrapped with 6 is inserted into the second heat-shrinkable tube 118. Second heat-shrinkable tube 118
Is shorter than the first heat-shrinkable tube 114 and does not cover the second body 110 of the sleeve mandrel 106.
In the illustrated embodiment, the second heat-shrinkable tube 118
Is about 4.0 inches long.

The second heat-shrinkable tube 118 is shrunk at an appropriate position on the first heat-shrinkable tube 114 by heating again using an oven or a heat gun. The second heat-shrinkable tube 118 retains and covers the wrapped reinforcing fibers 116 and the first heat-shrinkable tube 114 below it when contracted in place (see FIG. 6C). ).

As shown in FIG. 6D, the reinforcing fibers 116 are
Of the second heat-shrinkable tube 118 to the notch 112. The reinforcing sleeve assembly 104 is removed from the sleeve mandrel 106.

By inserting a main support wire 78 into the reinforced sleeve assembly 104, which is connected to the distal end of the shaft 62 (see FIG. 3), the large diameter portion of the reinforced sleeve assembly 104 is moved away from the shaft 62. Allow it to slide on the side edges. At this time, the left and right steering wires 56, 58 and the strengthening spring assembly 9
0 is connected to the main support wire 78. The conductive wire 100 also extends along the main support wire 78 and passes through the inner bore of the shaft 62.

The second heat-shrinkable tube 118 is placed in place over the distal end of the shaft 62, the main support wire 78, and its associated parts by heating again using an oven or heat gun. Finally shrink. The stiffening sleeve assembly 104 tightly covers the main support wire 78 when it eventually contracts in place.

The wrapped reinforcing fibers 116 form a component of the reinforcing sleeve assembly 104. The stiffening sleeve assembly 104 is sufficiently flexible to allow the desired bending of the electrode assembly 16. In addition, because the reinforcing fibers 116 are wrapped, the reinforcing sleeve assembly 104 has increased strength during repeated flexing action and improved resistance to wear and tear.

The reinforcing sleeve assembly 104 also holds the steering wire 5 in close contact with the main support wire 78.
Hold 6, 58 and conductive wire 100. Due to such close contact, the steering wire 5
6,58 and conductive wire 100 are prevented from kinking or chafing.

The materials used to form the reinforcing sleeve assembly 104 can vary. In the illustrated embodiment, the first and second heat shrinkable tubes 114 and 118.
Is a medical grade TFE with 2 to 1 shrinkage
It is made of Teflon material. This material has a very low wall thickness (after heat shrink) of about 0.003 to 0.0045 inches. In the illustrated embodiment, the reinforcing fibers 116.
Is Kevlar 49 yarn (commercially available from Deupon). This material is about 400,000 lb
Tensile strength of s / in ² and about 18,000,000
It has a modulus of lbs / in ² .

The reinforcing sleeve assembly 104 is attached to the outer tube 1.
Cover with 20. Tip electrode 96 and ring electrode 98
To the conductive wire 100 and to the outer tube 120 by conventional methods. Thus, the electrode assembly 1
6 is completed.

In the illustrated embodiment, the curvature that bends the electrode assembly 16 to the left is such that
Is different from the curvature that bends to the right. Electrode assembly 16
Has a different curvature when bent to the left and when bent to the right. This difference in curvature allows the physician the flexibility to steer the tip electrode 96 to the proper position. These different curvatures are called asymmetric curves.

Five representative asymmetric curves, which are embodiments of the present invention, are shown in the figure. These 5 different curves are 2
It is achieved by changing one relationship.

The first relationship is that the cam radius on the left surface 46 of the cam front surface 40 of the cam wheel 22 and the left surface 52 of the cam rear surface 42 and the right surface 4 of the cam front surface 40 of the cam wheel 22.
4 and the cam radius on the right surface 50 of the cam rear surface 42. According to the present invention, varying the cam radius allows for various asymmetric cam configurations.

The second relationship is the connecting point of the left steering wire 58 to the left side 78L of the main support wire 78 and the right steering wire 56 to the right side 78R of the main support wire 78.
Is the relationship with the connection point of. According to the present invention, a variety of symmetrical and asymmetrical steering wire connection points can be used due to the variation of the connection points.

The asymmetric cam configuration and the symmetrical and asymmetric steering wire connections constitute various asymmetric curves. The five curves shown are for showing the idea that an asymmetric curve is formed by changing the above two relationships, and do not limit the scope of the present invention.

Asymmetric Curve 1 As shown in FIGS. 7A to 7C, the catheter 10 is
The cam wheel 22 has an asymmetric cam front surface 40 and a symmetrical cam rear surface 42. Further, in the electrode assembly 16, the left side 78L and the right side 78R of the main support wire 78 are
With respect to the left steering wire 56 and the right steering wire 5
8 are connected asymmetrically.

More specifically, the right surface 44 of the cam front surface 40
Has a radius of 0.3125 inches and the left side 46 is
It has a radius of 0.4062 inches. The right side 50 and the left side 52 of the cam back surface 42 each have a radius of 0.313 inches.

The right steering wire 56 is the main support wire 7
8 and the left steering wire 58 is connected to the main support wire 78 at a position approximately 1.5 inches from the distal end tip 88 of the main support wire 78.

When the control lever 34 rotates clockwise,
According to the above relationship, the main supporting wire 78 is bent to the right by about 270 ° to form a “pig's tail” loop. When the control lever 34 rotates counterclockwise,
Due to the above relationship, the main supporting wire 78 is bent to the left by about 90 °, thereby forming an L-shaped curve.

Asymmetric Curve 2 As shown in FIGS. 8A-8C, the catheter 10 is
The cam wheel 22 has a symmetrical cam front surface 40 and a symmetrical cam rear surface 42. Further, in the electrode assembly 16, the left side 78L and the right side 78R of the main support wire 78 are
With respect to the left steering wire 56 and the right steering wire 5
8 are connected asymmetrically.

More specifically, the right surface 44 of the cam front surface 40
And the left side 46 each has a radius of 0.4062 inches. The right side 50 and the left side 52 of the cam rear surface 42 each have a radius of 0.313 inches.

The right steering wire 56 is the main support wire 7
8 and the left steering wire 58 is connected to the main support wire 78 at a position approximately 1.5 inches from the distal end tip 88 of the main support wire 78.

When the control lever 34 rotates clockwise,
According to the above relationship, the main supporting wire 78 is bent to the right by about 135 °, thereby forming an arc-shaped curve.
When the steering lever 34 rotates counterclockwise, the main support wire 78 bends to the left by about 90 ° due to the above relationship, thereby forming an L-shaped curve (similar to the first asymmetric curve).

Asymmetric Curve 3 As shown in FIGS. 9A-9C, the catheter 10
The cam wheel 22 has an asymmetric cam front surface 40 and a symmetrical cam rear surface 42. Further, in the electrode assembly 16, the left side 78L and the right side 78R of the main support wire 78 are
With respect to the left steering wire 56 and the right steering wire 5
8 are connected symmetrically.

More specifically, the right surface 44 of the cam front surface 40
Has a radius of 0.3125 inches and the left side 46 is
It has a radius of 0.4062 inches. The right side 50 and the left side 52 of the cam rear surface 42 each have a radius of 0.313 inches.

Both the right steering wire 56 and the left steering wire 58 are connected to the distal end tip 88 of the main support wire 78.

When the control lever 34 rotates clockwise,
Due to the above relationship, the main supporting wire 78 is bent to the right by about 270 °, so that a “pig tail” loop (on the right side, similar to the first asymmetric curve in which the relationship between the cam and the steering wire is the same) ) Is formed. Steering lever 34
When is rotated counterclockwise, due to the above relationship, the main support wire 78 bends to the left by about 80 °,
Form an arc-shaped curve. Asymmetric Curve 4 As shown in FIGS. 10A to 10C, the cam wheel 22
Both the cam front surface 40 and the rear surface 42 of the cam are asymmetrical. In the electrode assembly 16, the left side 7 of the main support wire 78
The left steering wire 56 and the right steering wire 58 are symmetrically connected to the 8L and the right surface 78R.

More specifically, the right surface 44 of the cam front surface 40
Has a radius of 0.3125 inches and the left side 46 is straight. This straight line extends along a tangent along the circumference of the inner center of the cam wheel 22 and is curved (non-linear).
Cross the right side 44 of the.

The left surface 52 of the cam rear surface 42 extends in an arc shape from a tangent line along the circumference of the inner center. In contrast, the right side 50 of the cam rear side 42 is asymmetric and has a radius of 0.313 inches.

Both the right steering wire 56 and the left steering wire 58 are connected to the distal end tip 88 of the main support wire 78.

When the control lever 34 rotates clockwise,
According to the above relationship, the main support wire 78 bends to the right by about 135 °, thereby forming an arc-shaped curve. When the control lever 34 rotates counterclockwise, the above-mentioned relationship causes the main support wire 78 to bend to the left by about 135 ° against the resistance force of the spring, thereby forming a “shepherd's hook” -shaped curve. To do.

Asymmetric Curve 5 As shown in FIGS. 11A to 11C, the catheter 10
Has an asymmetric cam front surface 40 and a symmetric rear surface 42 of the cam wheel 22. In the electrode assembly 16, with respect to the left side 78L and the right side 78R of the main support wire 78,
The left steering wire 56 and the right steering wire 58 are symmetrically connected.

More specifically, the right surface 44 of the cam front surface 40
Has a radius of 0.3125 inches and the left side 46 is
It has a radius of 0.4062 inches. The right side 50 and the left side 52 of the cam back surface 42 each have a radius of 0.313 inches.

Both the right steering wire 56 and the left steering wire 58 are connected to the distal end tip 88 of the main support wire 78.

When the control lever 34 rotates clockwise,
By virtue of the above relationship, the main support wire 78 bends about 270 ° to the right to form a “pig's tail” loop (similar to the first and third asymmetric curves). When the control lever 34 is rotated counterclockwise, the main support wire 78 is bent to the left by about 135 ° due to the above relationship, so that the “shelter hook” curve (similar to the fourth asymmetric curve) is generated. Form.

To achieve the above five asymmetric curves,
The changes in the above relationships are summarized in Table 1 below.

[0098]

[Table 1]

Note) The left cam and the right cam in the above table are those on the front surface of the cam. In curves 1, 2, 3, and 5, the left and right faces of the cam rear face are symmetrical, 0.3
It has a radius of 13 inches. In curve 4, the left and right surfaces of the cam rear surface are asymmetrical, and the right surface is 0.3125.
It has a radius of inches and the left side is straight.

[0100]

As described above, according to the present invention, the cam radius on the left side of the cam front surface and the left side of the cam rear surface of the cam wheel, and the cam radius on the right side of the cam front side and the right side of the cam rear side of the cam wheel. And the connection point of the left steering wire to the left side of the main support wire and the connection point of the right steering wire to the right side of the main support wire by changing the catheter tip,
A desired shape can be easily and accurately formed.

[Brief description of drawings]

FIG. 1 is a perspective view of a catheter according to one embodiment of the present invention.

2 (A) is a schematic view of the catheter of FIG.
2B is a cross-sectional view taken along the line 2A, and FIG. 2B is an exploded view of FIG.

FIG. 3 is an exploded perspective view of the electrode assembly of the catheter.

FIG. 4 is a perspective view of another guide tube for a catheter.

FIG. 5 is a perspective view, with a portion broken away, of a stiffening assembly for the main support wire of a catheter.

6 (A) -6 (D) are exploded perspective views showing a reinforced tube covering a main support wire of a catheter.

7 (A) to (C) are views showing a steering mechanism of a curve 1 of the catheter.

8A to 8C are views showing a steering mechanism of a curve 2 of the catheter.

9A to 9C are views showing a steering mechanism of a curve 3 of the catheter.

10A to 10C are views showing a steering mechanism of a curve 4 of the catheter.

11 (A) to (C) are views showing the steering mechanism of the curve 5 of the catheter.

[Explanation of symbols]

 10 catheter 12 handle assembly 14 guide tube assembly 16 electrode assembly 18 sleeve 22 cam wheel 34 steering lever 40 cam front surface 42 cam rear surface 44 cam front right surface 46 cam front left surface 50 cam rear right surface 52 cam rear left surface 56 right steering wire 58 Left steering wire 78 Main support wire

Continuation of front page (72) Inventor Russell Bee. Thompson United States California 94025, Menlo Park, Number 4, University Drive 675

Claims (11)

[Claims] 1. A catheter comprising: body means bendable in response to external forces applied in different first and second directions; and the body means in the first and second directions. A steering means movable to the first and second passages for applying an external force to the main body means in response to the movement to the first passage. The first
A first actuator means for bending into a first predetermined non-linear shape in the direction of, and responsive to movement into the second passage to move the body means into the second
A second actuator means that is bent in the direction of to a second predetermined non-linear shape different from the first predetermined non-linear shape. 2. The catheter of claim 1, further comprising a guide tube having a distal end connected to the body means and a proximal end connected to the steering means. 3. The body means includes a flexible wire member including a left side surface and a right side surface, and the steering means has a left side steering having distal end portions respectively connected to the left side surface and the right side surface of the wire member. A wire and a right steering wire, wherein the first actuator means pulls the left steering wire to bend the wire member leftward to the first predetermined non-linear shape, 2. The second actuator means bends the wire member to the right into the second predetermined non-linear shape by pulling the right steering wire to the right.
The catheter according to. 4. The connecting points at the distal ends of the left and right steering wires are generally symmetrical on the left and right sides of the wire member.
The catheter according to claim 3. 5. The catheter of claim 3, wherein the connection points at the distal ends of the left and right steering wires are generally asymmetrical on the left and right sides of the wire member. 6. The steering means comprises: a wheel to which proximal ends of the left steering wire and the right steering wire are connected; and means for rotating the wheel to the left and right. Actuator means includes a first cam surface on a left side of the wheel that presses and pulls the left steering wire in response to rotation of the wheel to the left, the second actuator means of Includes a second cam surface on the right side of the wheel that pushes and pulls the right steering wire in response to rotation of the wheel to the right, the second cam surface being different from the first cam surface. The catheter according to claim 3. 7. The first cam surface and the second cam surface are surfaces including curves having different radii.
The catheter according to claim 6. 8. The catheter of claim 6, wherein one of the first cam surface and the second cam surface is generally linear and the other is generally non-linear. 9. The body comprises a wire member having opposite ends and responsive to external forces, the wire member having one end flexed relative to the other end. The catheter according to claim 1, further comprising hardening means for changing the hardness of the wire member so that the resistance of the wire member is increased. 10. A guide tube further comprising a distal end connected to the steering means and a handling means connected to a proximal end of the guide tube for holding the steering means. The catheter according to Item 1. 11. A coefficient of friction for the handling means to grip the guide tube and convert rotation of the handling means about the axis of the guide tube into rotation about the axis of the guide tube itself. 2. A sleeve means having a
The catheter according to 0.