JP2022124298A - Device for perforating body tissue - Google Patents

Abstract

To provide a body tissue boring device.SOLUTION: A body tissue boring device 10 comprises: a tubular body part 12, the body part 12 having a tip opening part 20, at its tip, at which a lumen 16 is kept in an open state; a boring head 14 disposed so as to be apart from the body part 12 on the tip side; and a coupling member 22 that couples the body part 12 with the boring head 14 while keeping the tip opening part 20 in an open state. The coupling member 22 is fastened to the body part 12 in a state of being inserted from the tip opening part 20 of the body part 12 into the lumen 16. A communication path 26 extending in an axial direction between an outer peripheral surface of the coupling member 22 and an inner peripheral surface of the body part 12 is provided. The tip opening part 20 is configured by the lumen 16 being kept in an open state at the tip of the body part 12 through the communication path 26.SELECTED DRAWING: Figure 1

Description

The present invention relates to a body tissue perforation device for forming a patent hole in body tissue such as the interatrial septum.

Conventionally, as one of treatment methods for atrial fibrillation, a technique of cauterizing an appropriate portion of the left atrium with an ablation catheter has been adopted. The ablation catheter may be inserted through the interatrial septum from the right atrium to the left atrium, in which case it is necessary to preform a patent opening through the interatrial septum. For perforation of the interatrial septum, for example, a method of forming a patent foramen by the Brockenbrough method of puncturing the fossa ovalis is known. In the Brockenblow method, a perforation device such as the medical device shown in Japanese Patent No. 6416084 (Patent Document 1) having a structure in which a puncture needle is passed through the lumen of the tube is used to insert the tube into the right atrium. A patent foramen is formed by piercing the fossa ovalis with a puncture needle protruding from the tip.

Japanese Patent No. 6416084

By the way, in Patent Document 1, an opening is formed in the distal portion of the tube, and for example, it is possible to discharge a contrast medium, physiological saline, etc. from the lumen of the tube through the opening at the distal end of the tube. there is

However, in the perforation device described in Patent Document 1, the opening on the distal end side (front end side) of the tube is closed, and the lumen is opened to the outside through a window opening on the side surface of the tube. Therefore, the direction in which the fluid is discharged through the tube, for example, is restricted to the specific direction in which the window is opened. In addition, the window opening in a specific direction on the outer periphery of the tube may be covered by contact with the inner wall of the body cavity. For this reason, for example, the suction of fluid from the body through the lumen of the tube may be restricted or difficult.In addition, when detecting the pressure inside the body through the lumen of the tube, the accuracy and stability of detection may decrease. Or, there was a possibility that detection would become difficult.

The problem to be solved by the present invention is to provide a novel body tissue perforation device that can reduce or eliminate at least one of the inherent problems of the conventional product described in Patent Document 1 and improve usability. That's what it is.

Hereinafter, preferred embodiments for understanding the present invention will be described. can be recognized and employed as independently as possible, and can also be employed in combination with any of the components described in other aspects as appropriate. Accordingly, the present invention can be implemented in various alternatives without being limited to the embodiments described below.

A first aspect is a device for piercing body tissue comprising a tubular body portion having a distal opening at the distal end thereof with a lumen maintained open, and a lumen extending from the body portion. A head for drilling is arranged at a distance on the distal end side, and a connecting member is provided for connecting the main body portion and the head for drilling while maintaining the opening of the distal end in an open state.

According to the body tissue perforating device of this aspect, the tubular main body and the perforating head are arranged separately, and the distal end of the main body is provided with a distal opening that maintains the lumen in an open state. It is Therefore, it is possible to stably secure the opening of the lumen to the outside without being excessively limited as in Patent Document 1. As a result, for example, it is possible to easily diversify the discharge direction of the fluid through the lumen and thus the distribution of the discharge pressure. In addition, it is possible to stabilize the open state of the lumen in the body, and for example, it becomes easy to perform suction of fluid through the lumen and pressure detection with high accuracy and stability.

A second aspect is the device for perforating body tissue according to the first aspect, wherein the connecting member is fixed to the body portion in a state of being inserted into the lumen from the tip opening of the body portion. A communicating passage is provided axially extending between the outer peripheral surface of the connecting member and the inner peripheral surface of the body portion, and the lumen is maintained open at the distal end of the body portion through the communicating passage. The tip opening is configured by being formed.

According to the body tissue perforating device of this aspect, since the connecting member that is fixed to the main body portion is arranged in the lumen, it is possible to easily realize the fixing of the connecting member and the main body portion. In addition, compared to the case where the base end of the connecting member is fixed to the outer peripheral side of the main body, it is possible to reduce or avoid an increase in the diameter of the device for perforating body tissue at the fixed part, so that the device can be inserted into the body. Insertability may be improved.

A third aspect is the device for perforating body tissue according to the second aspect, wherein the connecting member is configured using a plurality of linear bodies extending in the length direction of the main body portion. .

According to the device for perforating body tissue of this aspect, since the connecting member is configured using a plurality of filamentous bodies, it is possible to suppress bending rigidity while ensuring strength such as tensile strength of the connecting member. In addition, by employing a plurality of linear bodies, it becomes easy to maintain the communication state and secure the communication cross-sectional area for the lumens of the tube-shaped main body portion by utilizing the gaps between the linear bodies. Further, by adopting a plurality of linear bodies, it is possible to eliminate the gap between the linear bodies while adopting linear bodies having a simple circular cross section without using a connecting member having a special outer peripheral shape with a non-circular cross section. It is also possible to secure a gap between the linear body and the body portion, and to use the gap to easily ensure the communication state of the lumen and the opening state to the outside.

A fourth aspect is the device for perforating body tissue according to the third aspect, wherein the plurality of filamentous bodies are twisted together.

According to the device for perforating body tissue of this aspect, the plurality of filamentous bodies are twisted to maintain the gap between the plurality of filamentous bodies, and the shape stability and the shape stability of the connecting member composed of the plurality of filamentous bodies can It is possible to improve strength and flexibility.

A fifth aspect is the device for perforating body tissue according to the third or fourth aspect, wherein the filamentous body is fixed to the body portion in a predetermined length region of the body portion. be.

According to the device for perforating body tissue of this aspect, it is possible to improve the fixing strength of the base end portion of the linear body inserted into the lumen of the body portion to the body portion and to further improve the shape stability.

According to a sixth aspect, in the device for perforating body tissue according to any one of the first to fifth aspects, the tip portion of the body portion is made of flexible synthetic resin.

According to the device for perforating body tissue of this aspect, it is possible to reduce the increase in deformation rigidity associated with, for example, fixation of the connecting member at the distal end portion of the body portion by adopting the synthetic resin.

According to the present invention, the lumen is maintained in an open state at the tip opening of the tube-shaped main body, and as described in Patent Document 1, the tip opening of the tube is closed. A novel device for perforating body tissue may be provided that may reduce or eliminate at least one of the problems with.

FIG. 2 is a plan view showing the tip portion of the device for perforating body tissue as the first embodiment of the present invention; Cross-sectional view showing an enlarged II-II cross section in FIG. FIG. 1 is an explanatory diagram for explaining a specific example of a treatment device when the body tissue perforation device shown in FIG. 1 is used for the Brockenblow method. FIG. 4 is a plan view showing a tip portion of a device for perforating body tissue as a second embodiment of the present invention; Cross-sectional view showing an enlarged VV cross section in FIG.

BEST MODE FOR CARRYING OUT THE INVENTION Hereinafter, embodiments of the present invention will be described with reference to the drawings.

1 and 2 show a high-frequency needle 10 as a first embodiment of a device for perforating body tissue according to the present invention. The high-frequency needle 10 has a structure in which a piercing head 14 is arranged on the distal end side of a tubular body portion 12 . Hereinafter, the base end side of the high-frequency needle 10, which is the side of the operator in use, will be referred to as the proximal end side, and the distal end side of the high-frequency needle 10, which will be the side of the patient, will be described as the distal end side.

The main body portion 12 has a hollow tubular shape with a lumen 16 extending longitudinally therethrough. The main body portion 12 is flexible and deformable following the curvature of a body lumen such as a blood vessel. The body portion 12 is made of metal, synthetic resin, fiber reinforced resin, carbon fiber reinforced thermosetting plastic (CFRP), or the like, and is preferably made of metal. In this embodiment, the body portion 12 is made of metal and has electrical conductivity.

An insulating layer 18 made of an electrical insulating material such as synthetic resin is provided on the outer peripheral side of the body portion 12 . The insulating layer 18 may cover only the body portion 12, or may cover not only the body portion 12 but also the outer peripheral surface of a later-described connecting member 22 (linear body 24) projecting from the body portion 12. Alternatively, the outer peripheral surface of the drilling head 14 on the proximal end side may also be covered. When the insulating layer 18 covers the connecting member 22, the insulating layer 18 covering the main body portion 12 and the insulating layer 18 covering the connecting member 22 (linear body 24) are made discontinuous. is kept open without being covered by the insulating layer 18 . However, the body portion 12 may be made entirely of insulating material, in which case the insulating layer 18 need not be provided.

In the present embodiment, the lumen 16 has a substantially constant circular cross section and extends in the central axis direction, which is the length direction of the body portion 12. However, the cross-sectional shape is not particularly limited, and for example, a branched structure on the proximal end side can be used. It is also possible to employ a cross-sectional expansion/contraction structure or the like. The body portion 12 of the present embodiment has a single lumen structure with only one lumen 16, but may have a multi-lumen structure with a plurality of lumens, for example. The lumen 16 has a large-diameter accommodating portion 19a at its distal end, and an annular step 19b is formed on the inner peripheral surface at the proximal end of the accommodating portion 19a. The lumen 16 extends longitudinally through the body portion 12 and extends distally through a distal end opening 20 as a tip opening that opens at the distal end of the body portion 12 and extends around the central axis. It is open all around 360 degrees.

A connecting member 22 extending in the longitudinal direction of the body portion 12 is arranged in the accommodation portion 19 a of the lumen 16 , and the body portion 12 and the drilling head 14 are connected by the connecting member 22 . Specifically, the length dimension of the connecting member 22 is such that the proximal end side of the connecting member 22 is inserted into the lumen 16 from the distal end opening 20 of the body portion 12, and the proximal end of the connecting member 22 is It abuts on the step 19b of the lumen 16. As shown in FIG. The movement of the connecting member 22 to the proximal side is restricted by the step 19b. Coupling member 22 is desirably flexible and, based on the flexibility of coupling member 22, can be adjusted with body portion 12 to follow the curvature of a body lumen, such as a blood vessel, into which the device is inserted. Deformable is desirable. The connecting member 22 is made of, for example, the same material as that of the body portion 12, and is preferably made of metal. In this embodiment, the connecting member 22 is made of metal and has electrical conductivity.

In particular, in this embodiment, the connecting member 22 is composed of a pair of linear bodies 24 , 24 . The pair of linear bodies 24 , 24 are adjacent to each other in the radial direction of the body portion 12 and extend parallel to each other in the length direction of the body portion 12 . The filamentous bodies 24 each have a length dimension shorter than the length dimension of the body portion 12 , and the distal ends of the filamentous bodies 24 extend from the body portion 12 through the distal end openings 20 of the body portion 12 . also protrudes distally. The distal end portion of the filamentous body 24 protrudes further to the distal end side than the body portion 12 with a certain length dimension. A portion of the linear body 24 located within the main body portion 12 (lumen 16 ) is fixed to the main body portion 12 . The linear body 24 only needs to have a relatively small outer diameter and extend in the longitudinal direction of the body portion 12, and is limited to a strictly linear form (having an extremely small outer diameter). not something.

In this embodiment, the linear body 24 has a circular cross section, and the outer diameter dimension of the linear body 24 is approximately half or slightly larger than the inner diameter dimension of the lumen 16 . As a result, portions of the linear bodies 24 , 24 adjacent in the radial direction of the main body portion 12 and located on the outer peripheral side are in contact with the inner peripheral surface of the main body portion 12 . The main body portion 12 and the linear bodies 24, 24 are fixed to each other in a predetermined region in the length direction of the main body portion 12. In this embodiment, the outer peripheral surface of the linear body 24 and the main body portion 12 It is fixed continuously over substantially the entire length of the contact portion with the inner peripheral surface. Alternatively, the proximal end of linear body 24 and step 19b of lumen 16 may be fixed. The method of fixing the linear body 24 and the body portion 12 is not limited, and they may be welded by means such as brazing, but in the present embodiment, they are welded by laser welding, resistance welding, or the like. . Adjacent linear bodies 24, 24 are preferably fixed to each other, but may not be fixed. The body portion 12 and the linear bodies 24, 24, which are both made of metal, are fixed to each other, so that the body portion 12 and the linear bodies 24, 24 are electrically connected.

As described above, in the present embodiment, the outer diameter of the linear body 24 is approximately 1/2 or slightly larger than the inner diameter of the lumen 16, and the diameter of the linear body 24 inside the lumen 16 is reduced. A pair is provided adjacent to each other in the direction (vertical direction in FIG. 2). 2, the lumen 16 is partitioned by the linear bodies 24, 24, and both sides (right and left in FIG. 2) of the lumen 16 sandwiching the linear bodies 24, 24 On both sides of the direction), between the outer peripheral surface of the connecting member 22 (linear bodies 24, 24) and the inner peripheral surface of the main body portion 12 in the axial direction (the length direction of the main body portion 12, which is shown in FIG. 1). Communicating passages 26, 26 extending in the lateral direction) are provided. A distal end opening 20 is formed by maintaining the lumen 16 in an open state at the distal end of the body portion 12 through the communicating passages 26 , 26 . In this embodiment, as shown in FIG. 2, the cross-sectional area of the connecting member 22 (the linear bodies 24, 24) is relatively small compared to the cross-sectional area of the lumen 16, so that the communication paths 26, 26 A relatively large cross-sectional area is ensured.

The distal end portions of the filamentous bodies 24, 24 protruding from the main body portion 12 toward the distal end side are connected to the drilling head 14, whereby the main body portion 12 and the filamentous bodies 24, 24 and the drilling head 14 are electrically connected. The piercing head 14 is generally coaxially arranged in extension of the central axis of the body portion 12 and is adapted to form a patent hole in bodily tissue by an external energy supply, such as a supply of energy. The applied radio frequency energy ablate the body tissue to form a patent hole in the body tissue. The energization of the drilling head 14 can also be achieved by providing dedicated wiring, but in the present embodiment, the conductive body portion 12 and the linear bodies 24, 24 are used as energization wiring. ing. As a result, simplification of the structure and reduction in the number of parts are realized.

Although the drilling head 14 is not limited to a specific shape, it has a curved surface with no corners on the distal side so that it is difficult to get caught when moving inside the lumen. For example, it has a substantially hemispherical shape that is convex toward the distal end, and has a warhead shape with a substantially round nose (round head bullet) as a whole. The outer diameter of the proximal end of the drilling head 14 may be larger or smaller than the inner diameter of the body portion 12, but in this embodiment is substantially the same as the outer diameter of the body portion 12. By setting the outer diameter of the proximal end of the drilling head 14 to be equal to or smaller than the inner diameter of the body portion 12 , for example, the fluid on the distal side of the drilling head 14 can flow through the distal end opening 20 . The flow resistance of fluids, such as when flowing inside body portion 12, may be reduced. The piercing head 14 is spaced distally with respect to the body portion 12 by having the filamentous body 24 protrude beyond the body portion 12 toward the distal end side. Proximal end opening 20 is maintained open all around on the distal end surface of body portion 12 proximal to piercing head 14 . That is, even if the main body portion 12 and the drilling head 14 are fixedly connected by the connecting member 22 (linear bodies 24, 24), the distal end opening 20 of the main body portion 12 is maintained in an open state. ing.

The fixing structure between the drilling head 14 and the connecting member 22 (linear bodies 24, 24) is not particularly limited. The tip of the connecting member 22 (linear bodies 24, 24) is press-fitted into the connecting member 22, and if necessary, it can be fixed by adhesion, welding, brazing, or the like.

In this embodiment, in the distal end portion of the high-frequency needle 10, a portion having a reduced outer diameter is provided between the piercing head 14 and the main body portion 12, with the linear bodies 24, 24 positioned therebetween. An annular space 28 communicating with the external space is formed around the linear bodies 24 , 24 . Since the communication passage 26 provided between the body portion 12 and the linear bodies 24, 24 in the lumen 16 communicates with the annular space 28 through the distal end opening 20, the length of the body portion 12 is A communication passage 26 extending in the direction communicates with the external space through an annular space 28 . Thereby, an annular space 28 is formed as an open portion to the outside on the distal end side of the lumen 16 . In this embodiment, the drilling head 14 and the body portion 12 are separated to some extent, and the annular space 28 is formed with a certain length dimension in the length direction of the body portion 12 .

The high-frequency needle 10 having such a structure is used, for example, in a procedure (Brockenblow method) for forming a patent foramen in the fossa ovalis A of the interatrial septum. For example, as shown in FIG. 3, the high-frequency needle 10 is inserted through a sheath 30 and inserted through the sheath 30 to a desired position in the body. A device other than the high-frequency needle 10 such as a dilator may be inserted through the sheath 30 as needed. In FIG. 3, for the sake of clarity, the high-frequency needle 10 is inserted through a dilator inserted into the sheath 30 outside the body (dilator in sheath). After being inserted into the body by a guide wire (not shown), it is passed through a dilator disposed within the sheath 30 .

A radio frequency generator 32 is connected to the body portion 12 of the radio frequency needle 10 . The high-frequency energy generated by the high-frequency generator 32 is supplied to the drilling head 14 through the body portion 12, thereby causing the drilling head 14 to drill. By attaching the counter electrode plate 34 connected to the high frequency generator 32 to the patient, the patient is prevented from being electrocuted when the high frequency is applied. If the body portion 12 is made of a non-conductive material, wiring for supplying high-frequency energy to the drilling head 14 may be provided separately from the body portion 12 . Alternatively, the connecting member 22 (linear bodies 24, 24) is provided with a length dimension reaching the proximal end of the main body portion 12, and the connector portion at the proximal end of the main body portion 12 directly receives high-frequency energy. RF energy may be supplied to the drilling head 14 without passing through the portion 12 .

Since the Brockenblow method has been known for a long time, a detailed description will be omitted. First, the operator inserts a dilator along a guide wire (not shown) that has been inserted in advance into a body lumen such as a blood vessel. The sheath 30 is inserted into the right atrium. Next, the operator inserts the high-frequency needle 10 through the dilator inserted into the sheath 30 from which the guide wire has been removed and into the right atrium.

Next, the practitioner protrudes the piercing head 14, which is the tip of the high-frequency needle 10, from the distal end of the sheath 30 and presses it against the fossa ovalis A of the interatrial septum. By supplying high-frequency power to the drilling head 14 pressed against the fossa ovalis A, the drilling head 14 performs a drilling action and forms a patent hole in the fossa ovalis A. As shown in FIG.

Whether or not a patent hole has been formed in the fossa ovalis A can be determined, for example, by pouring a contrast agent, physiological saline, or the like supplied from the proximal end of the high-frequency needle 10 through the distal end opening 20 of the main body portion 12, It can be determined by releasing it into the patient's heart and confirming an X-ray transmission image or an ultrasound image.

Further, whether or not a patent foramen has been formed in the fossa ovalis A and whether or not the high-frequency needle 10 has reached the left atrium from the right atrium through the patent foramen can be determined by measuring the pressure in the lumen 16 using the transducer 36 . It can also be determined by measuring. That is, as shown in FIG. 3, the transducer 36 is connected to the proximal end side of the main body portion 12 to convert the pressure in the lumen 16 into an electrical signal and display it on the monitor 38 . A pressurized bag 40 containing physiological saline is connected to the lumen 16 . Pressurized bag 40 prevents blood from flowing through lumen 16 to transducer 36 by supplying saline to lumen 16 at a pressure above blood pressure. Pressurization of lumen 16 by pressurization bag 40 may be controlled, for example, in response to intracardiac pressure acting within lumen 16 .

Prior to forming a patent foramen in the fossa ovalis A, when the tip of the high-frequency needle 10 is positioned in the right atrium, the right atrium acting on the lumen 16 through the open distal end opening 20. Intracardiac pressure is measured by transducer 36 and displayed on monitor 38 . Further, when the high-frequency needle 10 passes through the patent foramen of the fossa ovalis A and enters the left atrium, the intracardiac pressure of the left atrium acts on the lumen 16 through the opened distal end opening 20. Then, intracardiac pressure in the left atrium is measured by transducer 36 and displayed on monitor 38 . Since the intracardiac pressures in the right atrium and the left atrium are generally different, the change in the intracardiac pressure displayed on the monitor 38 allows the practitioner to know that the tip of the high-frequency needle 10 has reached the left atrium from the right atrium through the patent foramen. can be grasped.

The method for determining whether a patent hole has been formed and whether the tip of the high-frequency needle 10 has reached the left atrium can be, for example, the above-described method using X-rays, the method using ultrasonic waves, At least two of the methods using the transducer 36 or the like may be used in combination. Of course, the ejection of a contrast agent, saline, etc. from the distal end opening 20 of the main body portion 12 is performed not only during the procedure for forming a patent foramen in the fossa ovalis A of the interatrial septum, but also during surgery. It may be done at an appropriate time during

In the high-frequency needle 10 of the present embodiment, the connecting member 22 (linear bodies 24, 24) protruding from the body portion 12 toward the distal end side separates the drilling head 14 from the body portion 12 toward the distal end side. It is held in place so that the distal end opening 20 of the body portion 12 remains open without being capped by the piercing head 14 . The distal end opening 20 communicates with the external space over the entire circumferential circumference through an annular space 28 between the axially opposed surfaces of the annular end surface of the main body portion 12 and the boring head 14 . Therefore, a fluid such as a contrast medium or physiological saline flowing inside the body portion 12 can be stably discharged with good flow efficiency. In addition, since the fluid in the body portion 12 flows stably and efficiently, for example, changes in intracardiac pressure can be detected more accurately by the transducer 36. It is also possible to quickly grasp that a patent hole has been formed in the fovea A and that the tip of the high-frequency needle 10 has reached the left atrium.

Also, connecting members 22 (linear bodies 24 , 24 ) connecting the drilling head 14 to spaced positions on the distal side of the body portion 12 extend from the distal end opening 20 of the body portion 12 into the lumen 16 . it is put in. As a result, the outer diameter of the high-frequency needle 10 is reduced compared to, for example, the case where the drilling head and the main body are connected by a connecting portion located on the outer peripheral side of the drilling head and/or the main body. be able to.

In the present embodiment, since the connecting member 22 is composed of the pair of linear bodies 24, 24, the contact state between the body portion 12 and the linear bodies 24, 24 is stably secured, and the lumen 16 is The cross-sectional area of the connecting member 22 can be relatively small compared to the cross-sectional area. As a result, a relatively large cross-sectional area can be secured for the communication paths 26, 26 between the main body portion 12 and the connecting member 22, and even when the connecting member 22 is provided inside the lumen 16, the main body It becomes easy to secure a passage cross-sectional area for the fluid flowing through the portion 12 .

Further, in the present embodiment, the outer peripheral side portion of the pair of radially adjacent linear bodies 24, 24 has a certain length dimension in the length direction of the main body portion 12 with respect to the inner peripheral surface of the main body portion 12. The pair of linear bodies 24, 24 and the body portion 12 are fixed continuously over substantially the entire length of the contact portion. As a result, even when the pair of linear bodies 24, 24 have a relatively small diameter, a sufficient fixing area can be secured, and the connecting member 22 (linear bodies 24, 24) can be attached to the body portion 12. , and thus the drilling head 14 can be stably fixed. In particular, in the present embodiment, since the pair of linear bodies 24, 24 and the body portion 12 are fixed by welding such as laser welding or resistance welding, for example, the connection member (linear body) and the body portion are fixed together. Better electrical conductivity is exhibited compared to the case where is adhered.

Next, FIGS. 4 and 5 show a high-frequency needle 50 as a second embodiment of the device for perforating body tissue according to the present invention. The high-frequency needle 50 of this embodiment has the same basic structure as the high-frequency needle 10 of the first embodiment, but the specific structures of the body portion 52 and the connecting member 54 are different. In the following description, members and portions that are substantially the same as those of the first embodiment are denoted by the same reference numerals as those of the first embodiment, and detailed description thereof will be omitted.

The main body portion 52 of this embodiment is tubular, and at least a distal end portion 56 as a tip portion is formed of flexible synthetic resin. The distal end portion 56 is a portion having a certain length dimension from the distal end portion of the main body portion 52 , for example, having substantially the same length dimension as the connecting member 54 or having a length greater than that of the connecting member 54 . It has a short length dimension. In this embodiment, the distal end portion 56 of the body portion 52 made of synthetic resin has a length dimension shorter than the length dimension of the connecting member 54, and the length direction of the distal end portion 56 is less than the length dimension of the connecting member 54. A connecting member 54 protrudes longitudinally outward from both sides (distal end side and proximal end side). In particular, in this embodiment, the portion of the body portion 52 closer to the proximal end than the distal end portion 56 is made of metal as in the first embodiment. The distal end portion 56 of this embodiment is made of a transparent material, and the connecting member 54 is shown through the distal end portion 56 in FIG.

Further, the connecting member 54 of this embodiment is composed of a plurality of linear bodies 58 as in the first embodiment. In particular, in this embodiment, five filaments 58 are provided and twisted together as shown in FIG. Note that the linear body 58 is also made of metal in this embodiment. Such connecting member 54 is inserted into lumen 16 through distal end opening 20 of body portion 52 and is secured to body portion 52 . As a result, the proximal end portion of the connecting member 54 is located closer to the proximal end than the distal end portion 56 of the main body portion 52 and extends to the portion of the main body portion 52 made of metal. The distal end of coupling member 54 is also connected to piercing head 14 .

In the present embodiment, the insulating layer 18 provided on the outer peripheral side of the main body portion 52 is a metal portion of the main body portion 52, and the connecting member 54 is formed between the drilling head 14 and the main body portion 52. It is installed in the exposed part. However, the insulating layer 18 may be provided over the entire body portion 52 . Further, in this embodiment, the main body portion 52 may be formed of synthetic resin over the entire length, and in this case, the insulating layer 18 provided on the outer peripheral side of the main body portion 52 may not be provided.

Also in this embodiment, the portion of the connecting member 54 (each linear body 58 ) located on the outer peripheral side is fixed to the inner peripheral surface of the main body portion 52 . Although the method of fixing the connecting member 54 and the main body portion 52 is not limited, the metal parts of the connecting member 54 and the main body portion 52 are welded by laser or the like as in the first embodiment. is preferred. Thereby, the connecting member 54 and the body portion 52 are electrically connected. The connecting member 54 and the distal end portion 56 of the main body portion 52 may be welded together, such as by brazing, or may be glued together.

In the high-frequency needle 50 configured as described above, not only between the outer peripheral surface of the connecting member 54 (each linear body 58) and the inner peripheral surface of the main body portion 52, but also between each linear body 58 constituting the connecting member 54 A communication passage 60 extending in the axial direction (the lengthwise direction of the main body portion 52) is also formed in the gap between them (for example, the portion on the inner peripheral side of each linear body 58 in FIG. 5). The communicating passage 60 is maintained in an open state at the distal end of the main body portion 52 to form the distal end opening 20 of the main body portion 52 . Therefore, the high-frequency needle 50 of this embodiment can also exhibit the same effects as those of the first embodiment.

Further, in the present embodiment, the communication passages 60 are also formed in the gaps between the linear bodies 58 formed by being twisted together, and the fluid such as the contrast medium and the physiological saline can flow. can also improve the flow efficiency of Furthermore, by twisting a plurality of linear bodies 58 together, the strength and flexibility of the connecting member 54 can be improved.

Furthermore, since the distal end portion 56 of the main body portion 52 is made of synthetic resin, it can be formed more flexibly than when it is made of metal, for example. This prevents the distal end portion of the high-frequency needle 50 from becoming difficult to deform due to the provision of the connecting member 54 . In particular, in this embodiment, the distal end portion of radiofrequency needle 50 is formed by flexible coupling member 54 and distal end portion 56 , both of which are formed by flexible connecting member 54 and distal end portion 56 , and which are located at body portion 52 proximally relative to distal end portion 56 . The end side is made of metal having greater bending strength than the distal end portion 56 made of synthetic resin. As a result, the pushability of the high-frequency needle 50 is improved, and the followability when it is inserted into a curved or bent portion at the distal end portion is improved. It becomes easy to reach the treatment site while following and deforming flexibly.

Although the embodiments of the present invention have been described in detail above, the present invention is not limited by the specific descriptions. For example, in the above-described embodiment, an example of using the body tissue perforation device to perforate the atrial septum (fossa ovalis) was described, but the body tissue forming the patent foramen is not limited to the atrial septum. .

Further, in the above embodiment, the connecting members 22, 54 are composed of a plurality of linear bodies 24, 58, but may be composed of a single hollow or solid linear body. In this case, for example, the outer diameter of the linear body is partially different in the circumferential direction, such as a polygonal outer cross-sectional shape, and the large-diameter portion is fixed to the inner peripheral surface of the main body. By doing so, it becomes possible to provide a communication path between the outer peripheral surface of the connecting member and the inner peripheral surface of the main body portion. The linear body may have a single structure made of metal, but may have a composite structure with a synthetic resin or the like in consideration of flexibility. For example, a composite structure in which a metal core wire is protected by a synthetic resin insulation coating may be used. Then, the insulating coating is stripped at both longitudinal ends of the linear body to expose the core wire, one of the exposed core wires is connected to the drilling head, and the other of the exposed core wires is connected to the main body portion made of metal. It may be fixed by welding or the like to make it conductive. The portion of the linear body covered with the insulating coating can be fixed to the inner peripheral surface of the main body portion by adhesion, welding, or the like. Of course, the tube-shaped main body portion and the connecting member do not necessarily have the conductive performance, and it is also possible to adopt an electrically insulating material. If electrical conductivity to the drilling head is required, it is possible to provide a conductive path such as a lead wire or a conductive film.

Further, in the above-described embodiment, the connecting members 22, 54 are inserted into the lumen 16 from the distal end openings 20 of the body portions 12, 52 so as to connect the piercing head 14 from the inner peripheral sides of the body portions 12, 52. Although the main body portions 12 and 52 are connected, for example, the perforating head and the main body portion may be connected from their respective outer peripheral sides. As a result, the lumen as a whole serves as a communication passage, allowing fluid such as a contrast medium and physiological saline to flow, thereby further improving the flow efficiency of the fluid.

The specific structures of the linear bodies 24 and 58 are not limited, either. Linear bodies having a hollow structure or the like may be employed, or the linear bodies 24 and 58 themselves may be made of a plurality of the same or different materials. It is also possible to employ a wire-like structure by twisting strands of different cross-sectional shapes and thicknesses.

In addition, the connecting member and the body portion need not be continuously fixed over the entire length in the predetermined region of the body portion, and may be intermittently fixed in the predetermined region in the length direction. good. The connecting member and the main body portion need only be fixed at least partly in their mutual abutting portions, and the entire tip opening portion is formed between the connecting member and the main body portion by deformation of the connecting member during the piercing operation. A gap may be provided to allow for deformation of the connecting member to the extent that it is not blocked by the drilling head.

The drilling head is not necessarily limited to high-frequency energy as long as it emits energy for drilling. For example, the head for drilling can be configured with a temperature-increasing body (thermal energy) that cauterizes the body tissue by heating it with an electric current or a laser, and it is also possible to employ a combination of multiple energies. . In addition to supplying energy from the outside of the device, means for storing energy inside may be provided. Further, the material, hardness, shape, etc. of the drilling head are not particularly limited, and may be the same material as the main body, for example.

The tip portion (distal end portion) of the body portion is provided with an opening portion that opens to the side surface of the body portion in addition to the tip opening portion (distal end opening portion) that opens to the tip surface of the body portion. may

10 high frequency needle (device for perforating body tissue)
12 Body portion 14 Drilling head 16 Lumen 18 Insulating layer 19a Accommodating portion 19b Step 20 Distal end opening (tip opening)
22 Connecting member 24 Linear body 26 Communication path 28 Annular space 30 Sheath 32 High frequency generator 34 Counter electrode plate 36 Transducer 38 Monitor 40 Pressure bag 50 High frequency needle (device for perforating body tissue)
52 body portion 54 connecting member 56 distal end portion (tip portion)
58 linear body 60 communicating path A fossa ovalis

Claims (6)

A body tissue piercing device comprising a tubular body portion, comprising:
the body portion has a distal opening at the distal end where the lumen remains open;
A piercing head is disposed distally away from the body portion,
A body tissue piercing device comprising a connecting member connecting the body portion and the piercing head while maintaining the tip opening open. The connecting member is fixed to the main body in a state of being inserted into the lumen from the tip opening of the main body, and is between the outer peripheral surface of the connecting member and the inner peripheral surface of the main body. 2. The body according to claim 1, further comprising a communication passage extending axially through said lumen, said lumen being maintained open at said distal end of said body portion through said communication passage to define said distal opening. Device for tissue perforation. 3. The device for perforating body tissue according to claim 2, wherein the connecting member comprises a plurality of filamentous bodies extending in the longitudinal direction of the body portion. 4. The device for perforating body tissue according to claim 3, wherein the plurality of linear bodies are twisted together. 5. The device for perforating body tissue according to claim 3 or 4, wherein the filamentous body is fixed to the body portion in a predetermined length region of the body portion. The device for perforating body tissue according to any one of claims 1 to 5, wherein the tip portion of the body portion is made of flexible synthetic resin.

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