Device for perforating body tissue

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

[Technical field]

[0001] The present invention relates to a tissue piercing device for creating a patent hole in tissue such as the atrial septum. [Background technology]

[0002] Conventionally, as one of the 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 from the right atrium to the left atrium through the atrial septum, and in that case, a patent hole penetrating the atrial septum must be formed in advance. For example, a method of forming a patent hole by the Brockenbrough method, which punctures the fossa ovalis, is known for perforating the atrial septum. In the Brockenbrough method, a perforation device such as the medical device shown in Japanese Patent No. 6416084 (Patent Document 1), which has a structure in which a puncture needle is inserted into the lumen of a tube, is used, and the puncture needle is protruded from the tip of the tube inserted into the right atrium to perforate the fossa ovalis, thereby forming a patent hole. [Prior art documents] [Patent documents]

[0003] [Patent Document 1] Patent No. 6416084 Summary of the Invention [Problem to be solved by the invention]

[0004] In Patent Document 1, an opening is formed in the distal portion of the tube, and for example, it is possible to release a contrast medium, saline, or the like from the lumen of the tube through the opening at the distal portion of the tube.

[0005] However, in the perforation device described in Patent Document 1, the opening at the distal end (tip side) of the tube is closed, and the lumen is opened to the outside through a window opening on the side of the tube. Therefore, for example, the direction in which a fluid is discharged through the tube is limited to the specific direction in which the window opens. In addition, the window opening in the specific direction on the outer circumference of the tube may be covered by contact with the inner wall of the body cavity. For example, this may limit or make it difficult to suction fluid from inside the body through the lumen of the tube, and may also reduce the accuracy and stability of detection or make detection difficult when detecting pressure inside the body through the lumen of the tube.

[0006] The problem to be solved by the present invention is to provide a novel device for perforating body tissue that can reduce or eliminate at least one of the problems inherent in the conventional product described in Patent Document 1, thereby improving usability, etc. [Means for solving the problem]

[0007] The following describes preferred embodiments for understanding the present invention, but the embodiments described below are merely illustrative and may be combined with one another as appropriate, and the multiple components described in each embodiment may be recognized and used independently as far as possible, and may also be combined with any of the components described in another embodiment as appropriate. As a result, the present invention is not limited to the embodiments described below, and various other embodiments may be realized.

[0008] The first aspect is a body tissue perforation device having a tubular main body portion, the main body portion having a tip opening at the tip where the lumen is kept open, a perforation head portion being disposed at a distance from the main body portion toward the tip side, and a connecting member is provided for connecting the main body portion and the perforation head portion while keeping the tip opening portion open. On the other hand, the connecting member and the drilling head are constructed as separate members. It is something.

[0009] According to the present embodiment of the body tissue perforation device, the tubular main body and the perforation head are disposed apart from each other, and the tip of the main body is provided with a tip opening for maintaining the lumen in an open state. Therefore, the opening of the lumen to the outside can be stably secured without being excessively limited as in Patent Document 1. As a result, for example, the discharge direction of the fluid through the lumen and thus the dispersion of the discharge pressure can be easily achieved. In addition, the open state of the lumen in the body can be stabilized, and for example, it becomes easy to perform the suction of the fluid through the lumen and the pressure detection with high accuracy and stability.

[0010] In a second aspect, in the body tissue perforation device according to the first aspect, a tip portion of the connecting member is inserted into a hole provided in the perforation head and fixed thereto, while the connecting portion Material The proximal end portion of the catheter is fixed to the main body portion in a state where it is inserted into the lumen from the distal end opening of the main body portion.

[0011] According to the present embodiment of the body tissue puncturing device, the connecting member fixed to the main body is disposed within the lumen, so that the connecting member can be easily fixed to the main body. Also, compared to a case where the base end of the connecting member is fixed to the outer periphery of the main body, it is possible to reduce or avoid an increase in the diameter of the body tissue puncturing device at the fixed portion, and the insertability into the body can be improved.

[0012] The third aspect is the above-mentioned 1 or 2 In the body tissue perforation device according to the second aspect, the connecting member is configured using a plurality of linear bodies extending in the longitudinal direction of the main body portion.

[0013] According to the present embodiment of the body tissue perforation device, the connecting member is constructed using a plurality of linear bodies, so that it is possible to suppress the bending rigidity while ensuring the tensile strength of the connecting member. In addition, by adopting a plurality of linear bodies, it is easy to maintain the communication state of the lumen of the tubular main body portion and ensure the communication cross-sectional area by utilizing the gaps between the linear bodies. Furthermore, by adopting a plurality of linear bodies, it is possible to adopt a linear body with a simple circular cross section without using a connecting member with a special outer peripheral shape with a non-circular cross section, while ensuring the gaps between the linear bodies and the gaps between the linear bodies and the main body portion, and to easily ensure the communication state of the lumen and the opening state to the outside by utilizing these gaps. A fourth aspect is a body tissue perforation device having a tubular main body, the body having a tip opening at the tip of which the lumen is kept open, and a perforation head is disposed at a distance from the main body to the tip side, and a connecting member is provided to connect the body and the perforation head while maintaining the tip opening in an open state, while the connecting member is fixed to the body in a state where it is inserted into the lumen from the tip opening of the body, and a communication passage is provided between the outer peripheral surface of the connecting member and the inner peripheral surface of the body, and the lumen is maintained in an open state at the tip of the body through the communication passage to form the tip opening, and the connecting member is formed using a plurality of linear bodies extending in the length direction of the body. According to the body tissue perforation device of this aspect, the tubular main body and the perforation head are disposed at a distance from each other, and a tip opening is provided at the tip of the body to maintain the lumen in an open state. Therefore, the opening of the lumen to the outside can be stably secured without being excessively limited as in Patent Document 1. As a result, for example, the discharge direction of the fluid through the lumen and therefore the dispersion of the discharge pressure can be easily achieved. In addition, the opening state of the lumen in the body can be stabilized, and for example, it becomes easy to perform the suction of the fluid through the lumen, pressure detection, etc. with high accuracy and stability. In addition, according to the present embodiment of the body tissue puncturing device, since the connecting member fixed to the main body is disposed within the lumen, it is possible to easily achieve fixation between the connecting member and the main body. Also, compared to a case where the base end of the connecting member is fixed to the outer periphery of the main body, it is possible to reduce or avoid an increase in the diameter of the body tissue puncturing device at the fixed portion, and the insertability into the body can be improved. Furthermore, according to the present embodiment of the body tissue perforation device, the connecting member is constructed using a plurality of linear bodies, so that it is possible to suppress the bending rigidity while ensuring the tensile strength of the connecting member. In addition, by adopting a plurality of linear bodies, it is easy to maintain the communication state of the lumen of the tubular main body portion and ensure the communication cross-sectional area by utilizing the gaps between the linear bodies. Furthermore, by adopting a plurality of linear bodies, it is possible to adopt a linear body with a simple circular cross section without using a connecting member with a special outer peripheral shape with a non-circular cross section, while ensuring the gaps between the linear bodies and the gaps between the linear bodies and the main body portion, and to easily ensure the communication state of the lumen and the opening state to the outside by utilizing these gaps.

[0014] No. 5 The third aspect is Or the fourth In the body tissue perforation device according to the above aspect, the plurality of linear bodies are twisted together.

[0015] According to this embodiment of the device for body tissue perforation, by twisting together multiple linear bodies, it is possible to maintain gaps between the multiple linear bodies while improving the shape stability, strength, and flexibility of the connecting member made up of multiple linear bodies.

[0016] No. 6 The third aspect is ~ Any of the 5th In the body tissue perforation device according to the above aspect, the plurality of linear bodies are twisted together.

[0017] According to the body tissue perforation device of this embodiment, it is possible to improve the adhesion strength of the base end portion of the linear body inserted into the lumen of the main body portion and to further improve the shape stability of the main body portion.

[0018] No. 7 The above-mentioned first to third aspects are 6In the body tissue perforation device according to any one of the above aspects, the tip portion of the main body portion is formed from a flexible synthetic resin.

[0019] According to the body tissue perforation device of this embodiment, the use of synthetic resin makes it possible to reduce the increase in deformation rigidity at the tip portion of the main body, which is caused, for example, by the fastening of the connecting member. The eighth embodiment is a device for perforating body tissue comprising a tubular main body portion, the main body portion having a tip opening at the tip at which the lumen is maintained in an open state, and a perforation head portion is disposed away from the main body portion toward the tip side, and a connecting member is provided for connecting the main body portion and the perforation head portion while maintaining the tip opening in an open state, while an insulating layer fixedly provided on the main body portion and covering the outer periphery, and an insulating layer fixedly provided on the connecting member and covering the outer periphery are formed independently and discontinuously from each other. Effect of the Invention

[0020] According to the present invention, a lumen is maintained open at the tip opening of the tubular main body portion, thereby providing a novel device for perforating body tissue, which can reduce or eliminate at least one of the problems inherent in conventional products in which the tip opening of the tube is blocked, as described in Patent Document 1. [Brief description of the drawings]

[0021] [Figure 1] FIG. 1 is a plan view showing a tip portion of a body tissue perforation device according to a first embodiment of the present invention; [Diagram 2] FIG. 2 is an enlarged cross-sectional view taken along line II-II of FIG. [Diagram 3] FIG. 2 is an explanatory diagram for explaining a specific example of a treatment apparatus when the body tissue perforation device shown in FIG. 1 is used in the Brockenbrough method. [Figure 4] FIG. 1 is a plan view showing a tip portion of a body tissue perforation device according to a second embodiment of the present invention; [Diagram 5] FIG. 5 is an enlarged cross-sectional view of the VV section in FIG. 4. DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENTS

[0022] Hereinafter, an embodiment of the present invention will be described with reference to the drawings.

[0023] 1 and 2 show a high-frequency needle 10 as a first embodiment of a body tissue perforation device according to the present invention. The high-frequency needle 10 has a structure in which a perforation head 14 is disposed on the distal end side of a tubular main body portion 12. In the following description, the base end side of the high-frequency needle 10 that is on the practitioner side in use is referred to as the proximal end side, and the tip end side of the high-frequency needle 10 that is on the patient side is referred to as the distal end side.

[0024] The main body portion 12 is a hollow cylinder having a lumen 16 penetrating therethrough in the length direction. The main body portion 12 is flexible and can be deformed to follow the curvature of an internal lumen such as a blood vessel. The main 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 main body portion 12 is made of metal and is conductive.

[0025] An insulating layer 18 made of an electrically insulating material such as synthetic resin is provided on the outer periphery of the main body portion 12. The insulating layer 18 may cover only the main body portion 12, or may cover not only the main body portion 12 but also the outer periphery of a connecting member 22 (linear body 24) protruding from the main body portion 12, which will be described later, or may further cover the outer periphery of the proximal end side of the drilling head 14. 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, so that a distal end opening 20 of the main body portion 12, which will be described later, is not covered by the insulating layer 18 and is maintained in an open state. However, the main body portion 12 may be entirely made of an insulating material, in which case there is no need to provide the insulating layer 18.

[0026] In this 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 main body portion 12, but the cross-sectional shape is not particularly limited, and it is possible to adopt, for example, a branch structure on the proximal end side, or a cross-sectional expansion / contraction structure. The main body portion 12 in this embodiment has a single lumen structure having only one lumen 16, but may have, for example, a multi-lumen structure having multiple lumens. The lumen 16 has a large-diameter storage portion 19a at its distal end, and an annular step 19b is formed on the inner peripheral surface at the proximal end of the storage portion 19a. The lumen 16 penetrates the main body portion 12 in the length direction, and is opened toward the distal end side through a distal end opening 20 as a tip opening that opens at the distal end of the main body portion 12, over the entire circumference of 360 degrees around the central axis.

[0027] A connecting member 22 extending in the length direction of the main body portion 12 is disposed in the storage portion 19a of the lumen 16, and the main body portion 12 and the drilling head portion 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 main body portion 12, and the proximal end of the connecting member 22 abuts against a step 19b of the lumen 16. This step 19b limits the movement of the connecting member 22 to the proximal side. The connecting member 22 is desirably flexible, and is desirably deformable together with the main body portion 12 so as to follow the curvature of a body lumen such as a blood vessel into which the device is inserted based on the flexibility of the connecting member 22. The connecting member 22 is formed, for example, of the same material as the main body portion 12, and is preferably made of metal. In this embodiment, the connecting member 22 is formed of metal and is conductive.

[0028] Particularly, 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 main body portion 12 and extend parallel to each other in the longitudinal direction of the main body portion 12. The linear bodies 24 each have a length dimension shorter than the length dimension of the main body portion 12, and the distal end of the linear body 24 protrudes distally from the main body portion 12 through the distal end opening 20 of the main body portion 12. The distal end of the linear body 24 protrudes distally from the main body portion 12 with a certain length dimension. In addition, the part of the linear body 24 located inside the main body portion 12 (lumen 16) is fixed to the main body portion 12. Note that the linear body 24 is not limited to a strictly linear form (having an extremely small outer diameter) as long as it has a relatively small outer diameter and extends in the longitudinal direction of the main body portion 12.

[0029] In this embodiment, the linear body 24 has a circular cross section, and the outer diameter of the linear body 24 is approximately 1 / 2 or slightly larger than the inner diameter of the lumen 16. As a result, the portions of the linear bodies 24, 24 adjacent to each other in the radial direction of the main body portion 12 that are located on the outer circumferential side are in contact with the inner circumferential 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 longitudinal direction of the main body portion 12, and in this embodiment, they are fixed to each other continuously over approximately the entire length of the abutting portion between the outer circumferential surface of the linear body 24 and the inner circumferential surface of the main body portion 12. In addition, the proximal end of the linear body 24 may be fixed to the step 19b of the lumen 16. The method of fixing the linear body 24 to the main body portion 12 is not limited, and they may be welded by means of brazing or the like, but in this embodiment, they are welded by laser welding, resistance welding, or the like. It is preferable that adjacent linear bodies 24, 24 are fixed to each other, but they do not have to be fixed to each other. The main body portion 12 and the linear bodies 24, 24, both of which are made of metal, are fixed to each other, whereby the main body portion 12 and the linear bodies 24, 24 are electrically connected to each other.

[0030] As described above, in this 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 a pair of linear bodies 24 are provided adjacent to each other in the radial direction (vertical direction in FIG. 2) in the lumen 16. As a result, in the cross section of the main body portion 12 shown in FIG. 2, the lumen 16 is partitioned by the linear bodies 24, 24, and communication passages 26, 26 extending in the axial direction (the length direction of the main body portion 12, the horizontal direction in FIG. 1) between the outer circumferential surface of the connecting member 22 (linear bodies 24, 24) and the inner circumferential surface of the main body portion 12 are provided on both sides (horizontal and vertical directions in FIG. 2) of the linear bodies 24, 24 sandwiched between them in the lumen 16. The distal end opening 20 is formed by maintaining the lumen 16 in an open state at the distal end of the main body portion 12 through the communication passages 26, 26. In this embodiment, as shown in FIG. 2, the cross-sectional area of ​​the connecting member 22 (linear bodies 24, 24) is made relatively small compared to the cross-sectional area of ​​the lumen 16, so that the cross-sectional area of ​​the communication passages 26, 26 is ensured to be relatively large.

[0031] The distal end of the linear body 24, 24 protruding from the main body 12 toward the distal end side is connected to the drilling head 14, thereby electrically connecting the main body 12, the linear body 24, 24, and the drilling head 14. The drilling head 14 is generally arranged approximately coaxially on an extension line of the central axis of the main body 12, and forms a patent hole in the body tissue by supplying energy from the outside, for example, by cauterizing the body tissue with the supplied high-frequency energy to form a patent hole in the body tissue. Although the current can be applied to the drilling head 14 by providing a dedicated wiring, in this embodiment, the conductive main body 12 and the linear body 24, 24 are used as the current-applying wiring. This realizes a simplified structure and a reduced number of parts.

[0032] The drilling head 14 is not limited to a specific shape, but it is preferable that the distal surface is a curved surface without corners so that it is less likely to get caught when moving inside the lumen, and is, for example, made to be approximately hemispherical with a convex shape toward the distal end, and is made to have an approximately round-nosed bullet head shape as a whole. In the drilling head 14, the outer diameter of the proximal end may be larger or smaller than the inner diameter of the main body portion 12, but in this embodiment, it is made to be approximately the same as the outer diameter of the main body portion 12. In addition, by making the outer diameter of the proximal end of the drilling head 14 the same as or smaller than the inner diameter of the main body portion 12, the flow resistance of the fluid, for example, when the fluid distal to the drilling head 14 flows into the inside of the main body portion 12 through the distal end opening 20, can be reduced. The drilling head 14 is disposed at a distance from the distal end of the main body 12 due to the linear body 24 protruding further distally than the main body 12, and the distal end opening 20 of the main body 12 is maintained in an open state over the entire periphery on the end face on the distal end side of the main body 12, on the proximal end side of the drilling head 14. In other words, even if the main body 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 12 is maintained in an open state.

[0033] The fastening structure between the drilling head 14 and the connecting member 22 (linear body 24, 24) is not particularly limited, and for example, the tip of the connecting member 22 (linear body 24, 24) can be pressed into a hole formed in the center of the end face on the base end side of the drilling head 14, and the connecting member can be fastened by adhesive, welding, brazing, etc. as necessary.

[0034] In this embodiment, at the distal end portion of the high-frequency needle 10, between the drilling head 14 and the main body 12, there is provided a portion where the linear bodies 24, 24 are located and the outer diameter dimension is reduced, and an annular space 28 communicating with the external space is formed around the linear bodies 24, 24. The communication passage 26 provided between the main body 12 and the linear bodies 24, 24 in the lumen 16 communicates with the annular space 28 through the distal end opening 20, so that the communication passage 26 extending in the length direction of the main body 12 communicates with the external space through the annular space 28. As a result, the annular space 28 is formed as a portion open to the outside at the distal end side of the lumen 16. In this embodiment, the drilling head 14 and the main body 12 are separated to a certain extent, and the annular space 28 is formed with a certain length dimension in the length direction of the main body 12.

[0035] The high-frequency needle 10 having such a structure is used, for example, in a procedure (Brockenbrough technique) for forming a patent foramen in the fossa ovalis A of the atrial septum. For example, as shown in FIG. 3, the high-frequency needle 10 is inserted into a sheath 30 and inserted through the sheath 30 to a desired position in the body. An instrument other than the high-frequency needle 10, such as a dilator, may be inserted into the sheath 30 as necessary. For example, the high-frequency needle 10 is inserted into a dilator disposed in the sheath 30. For ease of understanding, FIG. 3 illustrates a state in which the high-frequency needle 10 is inserted into a dilator (dilator in sheath) inserted into the sheath 30 outside the body, but the high-frequency needle 10 is inserted into a dilator disposed in the sheath 30 after the sheath 30 is inserted into the body by a guide wire (not shown).

[0036] A high-frequency generator 32 is connected to the main body 12 of the high-frequency needle 10. High-frequency energy generated by the high-frequency generator 32 is supplied to the drilling head 14 through the main body 12, causing the drilling head 14 to perform drilling operations. A return electrode 34 connected to the high-frequency generator 32 is attached to the patient, thereby preventing the patient from receiving an electric shock when high-frequency current is applied. When the main body 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 main body 12. Alternatively, the connecting member 22 (linear members 24, 24) may be provided with a length dimension reaching the proximal end of the main body 12, and the connector portion at the proximal end of the main body 12 may receive high-frequency energy directly, thereby supplying high-frequency energy to the drilling head 14 without passing through the main body 12.

[0037] The Brockenbrough technique is well known and will not be described in detail here, but first, the practitioner inserts the sheath 30, into which a dilator has been inserted, along a guidewire (not shown) that has been inserted in advance into a lumen of the body such as a blood vessel, to the right atrium. Next, the practitioner inserts the high-frequency needle 10 through the dilator inserted into the sheath 30 from which the guidewire has been removed, and inserts it into the right atrium.

[0038] Next, the practitioner projects the perforation 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 atrial septum. By supplying high-frequency power to the perforation head 14 pressed against the fossa ovalis A, the perforation head 14 performs a perforation operation and forms a patent hole in the fossa ovalis A.

[0039] Whether or not a patent hole has been formed in the fossa ovalis A can be determined, for example, by releasing contrast agent or saline solution supplied from the proximal end of the high-frequency needle 10 into the patient's heart from the distal end opening 20 in the main body portion 12 and checking X-ray images or ultrasound images.

[0040] In addition, whether or not a patent hole 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 hole can also be determined by measuring the pressure in the lumen 16 using the transducer 36. That is, as shown in FIG. 3, the transducer 36 is connected to the proximal end side of the main body portion 12, and converts the pressure in the lumen 16 into an electric signal and displays it on a monitor 38. A pressurized bag 40 containing physiological saline is connected to the lumen 16. The pressurized bag 40 supplies physiological saline to the lumen 16 at a pressure equal to or higher than the blood pressure, thereby preventing blood from flowing into the transducer 36 through the lumen 16. The pressurization of the lumen 16 by the pressurized bag 40 can be controlled, for example, according to the intracardiac pressure acting in the lumen 16.

[0041] Before forming a patent hole in the fossa ovalis A, when the tip of the high-frequency needle 10 is positioned in the right atrium, the intracardiac pressure of the right atrium acting on the lumen 16 through the open distal end opening 20 is measured by the transducer 36 and displayed on the monitor 38. of When the tip of the high-frequency needle 10 passes through the patent foramen and enters the left atrium, the intracardiac pressure of the left atrium acts on the inside of the lumen 16 through the open distal end opening 20, and the intracardiac pressure of the left atrium is measured by the transducer 36 and displayed on the monitor 38. Since the intracardiac pressure of the right atrium and the left atrium is generally different, the practitioner can know that the tip of the high-frequency needle 10 has reached the left atrium from the right atrium through the patent foramen by the change in the intracardiac pressure displayed on the monitor 38.

[0042] The method for determining whether a patent hole has been formed or not and whether the tip of the high-frequency needle 10 has reached the left atrium may be a combination of at least two of the above-mentioned methods using X-rays, ultrasonic waves, and transducers 36. However, the contrast medium, saline, and the like may be discharged from the distal end opening 20 of the main body portion 12 not only during the procedure for forming a patent hole in the fossa ovalis A of the atrial septum, but also at an appropriate timing during the surgery.

[0043] In the high-frequency needle 10 of this embodiment, the drilling head 14 is held at a position away from the main body 12 toward the distal end by the connecting member 22 (linear bodies 24, 24) protruding from the main body 12 toward the distal end, and as a result, the distal end opening 20 of the main body 12 is maintained in an open state without being covered by the drilling head 14. This distal end opening 20 communicates with the external space over the entire circumferential direction through the annular space 28 between the axially opposing surfaces of the annular end face of the main body 12 and the drilling head 14, so that fluids such as contrast medium and physiological saline flowing inside the main body 12 can be discharged stably and with good flow efficiency. Furthermore, because the fluid within the main body portion 12 flows stably and efficiently, changes in intracardiac pressure, for example, can be detected more accurately by the transducer 36, making it possible to quickly determine, for example, that the high-frequency needle 10 has formed a patent hole in the fossa ovalis A of the atrial septum, or that the tip of the high-frequency needle 10 has reached the left atrium.

[0044] Furthermore, the connecting member 22 (linear bodies 24, 24) that connects the perforation head 14 to a position spaced apart from the distal side of the main body portion 12 is inserted into the lumen 16 from the distal end opening 20 of the main body portion 12. This allows the outer diameter of the high-frequency needle 10 to be smaller than when, for example, the perforation head and the main body portion are connected by a connecting part located on the outer periphery of the perforation head and / or the main body portion.

[0045] In this embodiment, since the connecting member 22 is composed of a pair of linear bodies 24, 24, the abutment state between the main body portion 12 and the linear bodies 24, 24 can be stably secured, while the cross-sectional area of ​​the connecting member 22 can be made relatively small compared to the cross-sectional area of ​​the lumen 16. As a result, the cross-sectional area of ​​the communication passages 26, 26 between the main body portion 12 and the connecting member 22 can be secured to be relatively large, and even when the connecting member 22 is provided inside the lumen 16, it is easy to secure the passage cross-sectional area of ​​the fluid flowing through the main body portion 12.

[0046] In addition, in this embodiment, the outer peripheral portions of the pair of linear bodies 24, 24 adjacent to each other in the radial direction abut against the inner peripheral surface of the main body portion 12 with a certain length dimension in the longitudinal direction of the main body portion 12, and the pair of linear bodies 24, 24 and the main body portion 12 are continuously fixed over substantially the entire length of the abutting portion. As a result, even if the pair of linear bodies 24, 24 has a relatively small diameter, a sufficient fixing area can be ensured, and the connecting member 22 (linear bodies 24, 24), and therefore the drilling head 14, can be stably fixed to the main body portion 12. In particular, in this embodiment, the pair of linear bodies 24, 24 and the main body portion 12 are fixed to each other by welding such as laser welding or resistance welding, and therefore good conductivity is exhibited compared to, for example, a case in which the connecting member (linear body) and the main body portion are bonded to each other.

[0047] 4 and 5 show a high-frequency needle 50 as a second embodiment of the body tissue perforation device according to the present invention. The high-frequency needle 50 of this embodiment has a similar basic structure to the high-frequency needle 10 of the first embodiment, but differs in the specific structures of the main body portion 52 and the connecting member 54. In the following description, members and parts that are substantially the same as those of the first embodiment are given the same reference numerals in the drawings, and detailed description thereof will be omitted.

[0048] The main body portion 52 of this embodiment is tubular, and at least the distal end portion 56 as the tip portion is made of a flexible synthetic resin. The distal end portion 56 is a portion having a certain length dimension from the distal end of the main body portion 52, and has, for example, a length dimension substantially the same as that of the connecting member 54 or a length dimension shorter than that of the connecting member 54. In this embodiment, the distal end portion 56 of the main body portion 52 formed of a synthetic resin has a length dimension shorter than that of the connecting member 54, and the connecting member 54 protrudes outward in the length direction from both sides (the distal end side and the proximal end side) of the distal end portion 56. In particular, in this embodiment, the proximal end side of the distal end portion 56 in the main body portion 52 is made of metal as in the first embodiment. Note that the distal end portion 56 of this embodiment is made of a transparent material, and in FIG. 4, the connecting member 54 is shown through the distal end portion 56.

[0049] 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 linear bodies 58 are provided, and as shown in FIG. 4, they are twisted together. In this embodiment, the linear bodies 58 are also made of metal. Such a connecting member 54 is inserted into the lumen 16 from the distal end opening 20 of the main body portion 52 and fixed to the main body portion 52. As a result, the proximal end 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 reaches the portion of the main body portion 52 made of metal. The distal end of the connecting member 54 is connected to the drilling head 14.

[0050] In this embodiment, the insulating layer 18 provided on the outer periphery of the main body portion 52 is provided on the portion of the main body portion 52 that is made of metal and on the portion where the connecting member 54 is exposed between the drilling head 14 and the main body portion 52. However, the insulating layer 18 may be provided over the entire main body portion 52. Also, in this embodiment, the main body portion 52 may be formed of a synthetic resin over its entire length, in which case the insulating layer 18 provided on the outer periphery of the main body portion 52 may not be provided.

[0051] Also in this embodiment, the portion of the connecting member 54 (each linear body 58) located on the outer periphery side is fixed to the inner periphery surface of the main body portion 52. The method of fixing the connecting member 54 and the main body portion 52 is not limited, but it is preferable that the connecting member 54 and the metallic portion of the main body portion 52 are welded by a laser or the like, as in the first embodiment. This electrically connects the connecting member 54 and the main body portion 52. The connecting member 54 and the distal end portion 56 of the main body portion 52 may be welded by brazing or the like, for example, or may be bonded.

[0052] In the high-frequency needle 50 having the above-mentioned shape, a communication passage 60 extending in the axial direction (the length direction of the main body portion 52) is formed not only between the outer circumferential surface of the connecting member 54 (each linear body 58) and the inner circumferential surface of the main body portion 52, but also in the gaps between each linear body 58 constituting the connecting member 54 (for example, the inner circumferential side of each linear body 58 in FIG. 5). The communication passage 60 is maintained in an open state at the distal end of the main body portion 52, thereby forming the distal end opening 20 of the main body portion 52. Therefore, the high-frequency needle 50 of this embodiment can also achieve the same effects as those of the first embodiment.

[0053] In this embodiment, the communication paths 60 are also formed in the gaps between the linear bodies 58 formed by twisting them together, allowing fluids such as contrast medium and saline to flow, thereby improving the efficiency of fluid flow. Furthermore, twisting a plurality of linear bodies 58 together also improves the strength and flexibility of the connecting member 54.

[0054] 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 formed of, for example, metal. 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 the high-frequency needle 50 is formed of the connecting member 54 and the distal end portion 56, both of which are flexible, and the proximal end side of the main body portion 52 from the distal end portion 56 is formed of a metal having a greater bending strength than the distal end portion 56 made of synthetic resin. This improves the pushability of the high-frequency needle 50, improves the followability of the distal end portion when it is inserted into a curved or bent part, and makes it easy to reach the treatment part while flexibly deforming to follow the shape of, for example, the sheath 30, a dilator, a catheter, etc.

[0055] Although the embodiment of the present invention has been described above in detail, the present invention is not limited to the specific description. For example, in the above embodiment, an example in which the body tissue perforation device is used to perforate the atrial septum (fossa ovalis) has been described, but the body tissue in which the patent hole is formed is not limited to the atrial septum.

[0056] In the above embodiment, the connecting member 22, 54 is 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 dimension of the linear body is made partially different in the circumferential direction, such as a polygonal outer sectional shape, and the large diameter part is fixed to the inner circumferential surface of the main body, so that a communication path can be provided between the outer circumferential surface of the connecting member and the inner circumferential surface of the main body. The linear body may be a single metal structure, but may be a composite structure with synthetic resin or the like in consideration of providing flexibility. For example, it may be a composite structure in which a metal core wire is protected by an insulating coating made of synthetic resin. Then, the insulating coating is stripped off at both ends in the length direction of the linear body to expose the core wire, and one of the exposed core wires may be connected to the drilling head, and the other exposed core wire may be fixed to the metal main body by welding or the like to conduct electricity. The part of the linear body covered with the insulating coating can be fixed to the inner circumferential surface of the main body by adhesion, welding, or the like. However, the conductive performance of the tubular main body and the connecting member is not essential, and electrically insulating materials can be used. If electrical conductivity is required for the drilling head, a conductive path such as a lead wire or a conductive film can be provided.

[0057] Furthermore, in the above embodiment, the connecting members 22, 54 are inserted into the lumen 16 from the distal end openings 20 of the main body parts 12, 52 to connect the drilling head 14 and the main body parts 12, 52 from the inner periphery side of the main body parts 12, 52, but for example, the drilling head and the main body parts may be connected from their respective outer peripheries. This makes the entire lumen a communicating passage through which fluids such as contrast medium and saline can flow, thereby further improving the efficiency of fluid flow.

[0058] The specific structure of the linear bodies 24, 58 is not limited, and a linear body having a hollow structure may be adopted, or the linear bodies 24, 58 themselves may be made of multiple wires of the same or different materials, cross-sectional shapes, and thicknesses twisted together to adopt a wire-like structure.

[0059] In addition, the connecting member and the main body portion do not need to be fixed continuously over the entire length in a predetermined region of the main body portion, but may be fixed intermittently in the length direction in a predetermined region. Note that it is sufficient that the connecting member and the main body portion are fixed to each other at at least a part of the abutting portion, and a gap may be provided between the connecting member and the main body portion to allow deformation of the connecting member to such an extent that the entire tip opening is not blocked by the drilling head due to deformation of the connecting member during drilling operation.

[0060] The perforation head is not necessarily limited to high-frequency energy as long as it emits energy for perforation. For example, the perforation head may be configured with a heating body (thermal energy) that cauterizes body tissue by heating with electricity or a laser, or a combination of multiple energies may be used. In addition to a mode in which energy is supplied from the outside of the device, a means for storing energy inside may be provided. Furthermore, the perforation head is not particularly limited in terms of material, hardness, shape, etc., and may be made of the same material as the main body, for example.

[0061] The tip portion (distal end portion) of the main body portion may be provided with an opening that opens into a side surface of the main body portion, in addition to a tip opening (distal end opening) that opens into the tip surface of the main body portion. Furthermore, the present invention essentially includes each of the inventions described in (i) to (vi) below, and the configurations and effects thereof will be described below. The present invention relates to (i) A body tissue perforation device having a tubular main body portion, the main body portion having a distal end opening at a distal end where a lumen is maintained in an open state, a perforation head portion disposed distally away from the main body portion, and a connecting member connecting the main body portion and the perforation head portion while maintaining the distal end opening in an open state; (ii) The body tissue perforation device according to (i), in which the connecting member is fixed to the main body portion in a state of being inserted into the lumen from the tip opening of the main body portion, and a communication passage is provided extending axially between the outer circumferential surface of the connecting member and the inner circumferential surface of the main body portion, and the lumen is maintained in an open state at the tip of the main body portion through the communication passage, thereby forming the tip opening. (iii) The body tissue perforation device according to (ii), wherein the connecting member is configured using a plurality of linear bodies extending in the longitudinal direction of the main body portion; (iv) The body tissue perforation device according to (iii), wherein the plurality of linear bodies are twisted together. (v) A body tissue perforation device according to (iii) or (iv), wherein the linear body is fixed to the main body portion at a predetermined length region of the main body portion. (vi) The body tissue perforation device according to any one of (i) to (v), wherein the tip portion of the main body portion is formed from a flexible synthetic resin. This includes inventions relating to. In the invention described in (i) above, the tubular main body and the drilling head are disposed apart from each other, and the tip of the main body is provided with a tip opening for maintaining the lumen in an open state. Therefore, the opening of the lumen to the outside can be stably secured without being excessively limited as in Patent Document 1. As a result, for example, the discharge direction of the fluid through the lumen and thus the dispersion of the discharge pressure can be easily achieved. In addition, the open state of the lumen in the body can be stabilized, and for example, it becomes easy to perform the suction of the fluid through the lumen and the pressure detection with high accuracy and stability. In the invention described in (ii) above, since the connecting member fixed to the main body portion is disposed in the lumen, it is possible to easily achieve the fixing of the connecting member to the main body portion. Also, compared to the case where the base end of the connecting member is fixed to the outer periphery of the main body portion, it is possible to reduce or avoid the increase in the diameter of the body tissue piercing device at the fixing portion, and the insertability into the body can be improved. In the invention described in (iii) above, the connecting member is constructed using a plurality of linear bodies, so that it is possible to suppress bending rigidity while ensuring the tensile strength of the connecting member. In addition, by employing a plurality of linear bodies, it is easy to maintain a communication state and ensure a communication cross-sectional area for the lumen of the tubular main body portion by utilizing the gaps between the linear bodies. Furthermore, by employing a plurality of linear bodies, it is possible to employ linear bodies with a simple circular cross section without using a connecting member with a special outer peripheral shape with a non-circular cross section, while ensuring gaps between the linear bodies and between the linear bodies and the main body portion, and to easily ensure a communication state of the lumen and an opening state to the outside by utilizing these gaps. In the invention described in (iv) above, by twisting together multiple linear bodies, it is possible to maintain gaps between the multiple linear bodies while improving the shape stability, strength, and flexibility of the connecting member made up of multiple linear bodies. In the invention described in (v) above, it is possible to improve the fixing strength of the base end portion of the linear body inserted into the lumen of the main body portion and to further improve the shape stability of the linear body. In the invention described in (vi) above, the use of synthetic resin makes it possible to reduce the increase in deformation rigidity at the tip portion of the main body, which is caused, for example, by the fastening of the connecting member. [Explanation of symbols]

[0062] 10 High frequency needle (tissue perforation device) 12 Main body part 14 Drilling head 16 Lumens 18 Insulating layer 19a Storage section 19b Step 20 Distal end opening (tip opening) 22 Connecting members 24 linear body 26 Communication path 28 Annular Space 30 Sheath 32 High Frequency Generator 34 Patient Electrode 36 Transducer 38 Monitors 40 Pressure Bag 50 High frequency needle (tissue perforation device) 52 Main body part 54 Connecting member 56 Distal end part (tip part) 58 Linear body 60 Communication path A. Fossa ovalis

Claims

1. 1. A body tissue piercing device comprising a tubular body portion, The body portion has a distal end opening at a distal end where a lumen is maintained open, A drilling head is disposed at a distance from the main body toward the tip side, A connecting member is provided for connecting the main body portion and the drilling head portion while maintaining the tip opening in an open state, A device for perforating body tissue, in which the connecting member and the perforation head are constructed as separate members.

2. The tip portion of the connecting member is inserted into a hole provided in the drilling head and fixed thereto, 2. The body tissue perforation device according to claim 1, wherein the proximal end portion of the connecting member is fixed to the body portion while being inserted into the lumen from the distal opening of the body portion.

3. 3. The body tissue perforation device according to claim 1, wherein the connecting member is configured using a plurality of linear members extending in the longitudinal direction of the main body portion.

4. A device for perforating body tissue comprising a tubular body portion, The body portion has a distal end opening at a distal end where a lumen is maintained open, A drilling head is disposed at a distance from the main body toward the tip side, A connecting member is provided for connecting the main body portion and the drilling head portion while maintaining the tip opening in an open state, the connecting member is fixed to the main body portion in a state of being inserted into the lumen from the tip opening of the main body portion, and a communication passage is provided extending in the axial direction between an outer circumferential surface of the connecting member and an inner circumferential surface of the main body portion, and the lumen is maintained in an open state at the tip of the main body portion through the communication passage, thereby forming the tip opening, A device for perforating body tissue, wherein the connecting member is constructed using a plurality of linear members extending in the longitudinal direction of the main body portion.

5. 5. The body tissue perforation device according to claim 3 or 4, wherein the plurality of linear members are twisted together.

6. 6. The body tissue perforation device according to claim 3, wherein the linear body is fixed to the main body portion over a predetermined length region of the main body portion.

7. 7. The body tissue perforation device according to claim 1, wherein the tip portion of the main body portion is formed from a flexible synthetic resin.

8. A device for piercing body tissue comprising a tubular body portion, The body portion has a distal end opening at a distal end where a lumen is maintained open, A drilling head is disposed at a distance from the main body toward the tip side, A connecting member is provided for connecting the main body portion and the drilling head portion while maintaining the tip opening in an open state, A body tissue perforation device in which an insulating layer fixedly attached to the main body portion and covering the outer circumferential side, and an insulating layer fixedly attached to the connecting member and covering the outer circumferential surface are formed independently and discontinuously from each other.

Images