CN109804505B

CN109804505B - Catheter tube

Info

Publication number: CN109804505B
Application number: CN201780062493.3A
Authority: CN
Inventors: 中神一树; 前川哲也
Original assignee: Lai Fuen Co ltd
Current assignee: Lai Fuen Co ltd
Priority date: 2017-01-10
Filing date: 2017-08-17
Publication date: 2021-04-13
Anticipated expiration: 2037-08-17
Also published as: TWI655814B; CN109804505A; WO2018131201A1; KR102141770B1; JP6722119B2; TW201826625A; PH12019500403A1; JP2018113121A; KR20190039605A

Abstract

A connector unit (100) of an electrode catheter is provided with: a pressure cover (110, 140) for radially spreading each of a plurality of electric wires (40) wound in a bundle at the center thereof and storing the electric wires; a housing (160) coupled to the crimp cap (110, 140); and a plurality of contacts (170) arranged substantially in a ring around the center of the housing (160); and when the press covers (110, 140) are combined with the shell (160), the plurality of electric leads (40) are respectively connected with the plurality of contacts (170) in a press connection mode.

Description

Catheter tube

Technical Field

The present invention relates to a medical instrument such as an electrode catheter (electrode catheter) used for diagnosis, treatment, and the like of arrhythmia, and a connector suitable for such a medical instrument and the like.

Background

As the medical instrument, an electrode catheter for diagnosing or treating, for example, arrhythmia of the heart is known. The electrode catheter is generally configured to include a hollow thin catheter (catheter tube) having a plurality of electrodes on a distal end side thereof, and a handle (handle) provided on a proximal end side of the thin catheter and held by an operator. Within the thin catheter, along its lumen (lumen), there are provided a plurality of electrical leads connected to the electrodes. The electric wire is formed by coating the outer periphery of the conductive core wire in an insulation coating mode. On the other hand, a relay (such as a connector) for transmitting and receiving electric power and electric signals to and from an external device such as a power supply device and an electrocardiograph is provided in the handle, and a plurality of electric wires are electrically connected to the relay to electrically conduct the electrodes (see, for example, patent document 1).

[ Prior art documents ]

[ patent document ]

(patent document 1) Japanese patent laid-open No. 2009-268696.

Disclosure of Invention

[ problems to be solved by the invention ]

However, in the past, an operation of peeling off the core wire by removing the insulating coating of the end portion of each electric wire and then connecting the core wire to a terminal (contact) of a connector with solder has been performed, and therefore, there has been a problem that the connection operation of the electric wires and the terminal requires many steps. In particular, in the case of an electrode catheter for simultaneously measuring a cardiac potential over a wide area in the heart, the number of electrodes for potential measurement is large, and the number of core wires to be connected to the respective electrodes is also large, so that the number of steps is also greatly increased in connection work between an electric lead and a terminal.

The present invention has been made in view of the above-described problems, and an object thereof is to provide a connector and a medical instrument capable of simply and reliably performing a connection operation of an electric wire.

[ means for solving problems ]

A connector according to the present invention is a connector which is provided between a first connection object member to which a plurality of electric wires are electrically connected and a second connection object member to be connected to the first connection object member, and which is capable of electrically connecting the plurality of electric wires to a connection object provided in the second connection object member to allow electric power and/or an electric signal to be transmitted and received between the first connection object member and the second connection object member, the connector including: a connector cover member for radially extending and accommodating each of a plurality of electric wires wound in a bundle shape at the center; a connector housing member coupled with the connector cover member; and a plurality of contacts (contacts) arranged substantially in a ring shape around a central portion of the connector housing member, wherein the connector is configured to: when the connector cover member is combined with the connector shell member, the plurality of electric leads are respectively connected with the plurality of contact pieces in a pressure welding mode.

The medical instrument of the present invention is provided with: a tube member having at least one lumen; a plurality of electrodes mounted to the tube member; a plurality of electrical leads configured to extend axially within the lumen of the tube member and have respective distal ends connected to respective ones of the plurality of electrodes; an operating member coupled to a base end side of the pipe member; and a connector for electrically connecting the plurality of electric wires to a connection object provided on the operation member, and for transmitting and receiving electric power and/or electric signals between the plurality of electrodes and the connection object; wherein the connector comprises: a connector cover member for radially extending and accommodating each of a plurality of electric wires wound in a bundle shape at the center; a connector housing member coupled with the connector cover member; and a plurality of contacts arranged substantially in a ring shape around a central portion of the connector housing member; wherein the connector is configured to: when the connector cover member is combined with the connector shell member, the plurality of electric leads are respectively connected with the plurality of contact pieces in a pressure welding mode.

In the above-described invention, it is preferable that the connector cover member includes a plurality of protrusions and a plurality of wire accommodating portions each formed in a concave shape between adjacent protrusions so as to radially expand each of the plurality of electrical wires to be accommodated therein.

In the above invention, it is preferable that the connector cover member is formed such that the adjacent protrusions have different heights.

In the above-described invention, it is preferable that the connector cover member includes a first connector cover member coupled to the connector housing member and a second connector cover member detachably attached to the first connector cover member, wherein the first connector cover member has the plurality of wire receiving portions formed between the adjacent projections, and the second connector cover member has a wire holding portion which abuts against the plurality of electrical wires received in the plurality of wire receiving portions and holds the plurality of electrical wires.

[ Effect of the invention ]

According to the connector and the medical instrument of the present invention, since the electrical leads held by the connector cover member and the contacts arranged on the connector housing member are connected by pressure contact to be electrically conducted when the connector cover member and the connector housing member are coupled, the electrical leads can be connected simply and reliably, and the manufacturing cost can be reduced.

Further, according to the connector and the medical instrument of the present invention, since the plurality of electrical wires wound in a bundle shape at the center are arranged so as to be radially expanded outward, and the plurality of contacts are arranged in a substantially annular shape around the center portion in a form capable of pressure-contact connection with the respective electrical wires, the connector as a whole can be made smaller as compared with a case where the contacts are arranged only in a straight line direction, the connector can be arranged in a space-saving manner without being restricted by the internal space of the medical instrument, and the degree of freedom of arrangement position of the connector and pulling-up of the electrical wires in the medical instrument can be improved.

In the above invention, the wire housing portion is formed to be recessed between the plurality of projections, so that the plurality of electric wires drawn out from the center can be accurately and easily arranged.

In the above invention, the height of the adjacent projections is different from each other, so that the electric wire can be easily positioned to the wire housing portion formed between the projections by the step difference between the projections, and therefore, the connection operation of the electric wire can be more easily performed.

In the above-described invention, if the electric wire accommodated in the wire accommodating portion is held by the wire holding portion, the electric wire is not displaced or loosened by a load generated when the electric wire is pressed against the contact, and the electric wire can be connected more reliably.

Drawings

Fig. 1 is a perspective view showing an electrode catheter according to an embodiment of the present invention.

Fig. 2 is a longitudinal sectional view showing the distal end portion of the electrode catheter.

Fig. 3 is an exploded perspective view of a handle of the electrode catheter.

Fig. 4 is a perspective view showing a connector unit mounted on the electrode catheter.

Fig. 5 is an exploded perspective view of the connector unit viewed from one end side.

Fig. 6 is an exploded perspective view of the connector unit as viewed from the other end side.

Fig. 7 is a plan view showing the connector unit.

Fig. 8 is a side view showing the connector unit.

Fig. 9 is a perspective view showing a state where the wires are arranged between the first crimp cover and the second crimp cover of the connector unit.

Fig. 10 is a perspective view showing a state in which the wires are arranged in the first crimp cover.

Fig. 11 is a perspective view showing the first crimp cover.

Fig. 12 is a plan view showing the entire wire part provided in the first crimp cover.

Fig. 13 is a perspective sectional view showing the whole line portion.

Fig. 14 is a longitudinal sectional view showing the first crimp cover.

Fig. 15 is a perspective view of the second crimp cover viewed from one end side.

Fig. 16 is a perspective view of the second crimp cover viewed from the other end side.

Fig. 17 is a perspective view showing the intermediate connector and the rigid board of the connector unit.

Fig. 18 is a top view showing the intermediate connector.

Fig. 19 is a bottom view showing the intermediate connector.

Fig. 20 is a perspective view showing a housing of the intermediate connector.

Fig. 21 is a perspective view showing a contact in the intermediate connector.

Fig. 22 is a side view showing the contact.

Fig. 23(a) is a schematic view showing a state before the wire is crimped to the contact, and fig. 23(B) is a schematic view showing a state after the wire is crimped to the contact.

Fig. 24 is a perspective sectional view showing a state where the wires are arranged in the first crimp cover.

Fig. 25 is an enlarged view showing a detailed configuration of a portion a in fig. 24.

Fig. 26 is a perspective sectional view showing a state after the second crimp cover is assembled to the first crimp cover.

Fig. 27 is an enlarged view showing a detailed configuration of a portion B in fig. 26.

Fig. 28 is a perspective sectional view showing a state where an intermediate connector is assembled to the first crimp cover and the second crimp cover.

Fig. 29 is an enlarged view showing a detailed configuration of a portion C in fig. 28.

Detailed Description

Preferred embodiments of the present invention will be described below with reference to the accompanying drawings. Fig. 1 to 3 show an electrode catheter 1 as an example of a medical instrument of the present invention, and first, the entire structure of the electrode catheter 1 will be described with reference to fig. 1 to 3. The electrode catheter 1 of the present embodiment is a so-called ablation catheter (ablation catheter) that is inserted into a body of a patient (for example, the inside of the heart) through a blood vessel, and that allows a high-frequency current to flow between the catheter electrode and an antipode plate attached to the body surface of the patient to provide a treatment for ablating cardiac tissue that causes arrhythmia.

[ electrode catheter ]

As shown in fig. 1, the electrode catheter 1 includes a main body including a thin flexible catheter (catheter tube)10 and a handle 20 for holding the thin flexible catheter 10.

As shown in fig. 2, the thin catheter 10 has a hollow structure (so-called single lumen structure) having one inner lumen extending along the central axis O of the tube 10. The thin catheter 10 is formed of, for example, a synthetic resin such as polyolefin (polyofine), polyamide (polyamide), polyether polyamide (polyether polyamide), or polyurethane (polyurethane). The length of the thin catheter 10 in the axial direction is preferably about 400 to 1500mm, more preferably about 700 to 1200 mm. The outer diameter of the thin catheter 10 is preferably in the range of 0.6 to 3.0mm, more preferably in the range of 1.3 to 3.0 mm. The inner diameter of the thin catheter 10 is preferably on the order of 0.5 to 2.5mm, more preferably on the order of 1.0 to 1.5 mm.

The entire thin catheter 10 may be formed of a tube having the same characteristics, but preferably the tip side exerts a relatively soft action (flexibility) and the base side exerts a relatively hard action (rigidity). In other words, the thin catheter 10 preferably has both flexibility necessary for bending with respect to the central axis O and rigidity necessary for being able to hold its posture to some extent. In addition, although the single lumen structure in which one lumen is formed in the thin catheter 10 is exemplified in the present embodiment, a multi-lumen structure in which a plurality of lumens are formed in the thin catheter 10, or a composite structure in which a region of the single lumen structure and a region of the multi-lumen structure are mixed in one thin catheter 10 may be employed.

A tip electrode 31 is fixed to the distal end of the thin catheter 10. A plurality of ring-shaped electrodes 32 are fixed at equal intervals in the axial direction in the vicinity of the front end electrode 31. The tip electrode 31 and the ring electrode 32 are fixed to the surface side of the thin catheter 10 in an exposed state. The electrode catheter 1 of the present embodiment measures the cardiac potential using the ring electrode 32, and applies high-frequency energy to the body tissue using the tip electrode 31 to cauterize the heart tissue. The tip electrode 31 and the ring electrode 32 are formed of a metal material having good electrical conductivity, such as aluminum, copper, stainless steel, gold, or platinum. The outer diameters of the distal electrode 31 and the ring electrode 32 are preferably about the same as the outer diameter of the thin catheter 10, and are generally about 0.5 to 3.0 mm.

A plurality of electrical wires (hereinafter, simply referred to as "wires") 40, an operation wire (wire)50, and a plate spring 55 are inserted into the lumen of the thin catheter 10 in an electrically insulated state. Here, the solder 60 for fixing the lead wire 40, the operation wire 50, and the plate spring 55 to the tip electrode 31 is filled inside the tip electrode 31. The material of the solder 60 is not particularly limited, and tin and lead are generally used, but tin-lead-silver or tin-lead-copper may be used, and lead-free tin-silver-copper, tin-silver-copper-bismuth, and the like may also be used. In addition, the side holes 18 penetrating the wall of the thin catheter 10 in the radial direction (inward-outward direction) are formed in the wall at positions corresponding to the positions where the annular electrodes 32 are disposed. The leading end side of the lead wire 40 is inserted through the side hole 18 and connected to the ring electrode 32 by spot welding or the like.

The respective leads 40 are connected to the

respective electrodes

31, 32 fixed to the thin catheter 10. In the present embodiment, 20 lead wires 40 are provided for 20

electrodes

31 and 32, and the

electrodes

31 and 32 and the lead wires 40 are connected in a one-to-one correspondence relationship. The lead wire 40 is connected to the

electrodes

31 and 32 at the tip end by welding, spot welding, or the like, and the lead wire 40 is connected to a connector unit 100 (described later in detail) disposed in the handle 20 at the base end by pressure contact. The detailed structure of each lead wire 40 will be described later, and is simply configured by coating the periphery of a metal core wire such as a copper wire with an electrically insulating resin.

On the other hand, the operation wire 50 extends across between the thin catheter 10 and the handle 20. The distal end of the operation wire 50 is fixed by welding or the like to the inside of the distal end electrode 31 provided at the distal end of the thin catheter 10, and the proximal end of the operation wire 50 is fixed to the inside of the grip (grip)21 of the handle 20. The manipulation wire 50 is formed using a super elastic metal material such as SUS (stainless steel) or NiTi (nickel titanium alloy). The diameter of the handling wire 50 is preferably on the order of 100 to 200 μm (e.g., 200 μm).

A leaf spring 55 is provided in the inner cavity of the thin catheter 10, and the leaf spring 55 is formed as a pendulum member deformable in a bending direction with respect to the center axis O. The plate spring 55 is disposed along the center axis O of the thin guide tube 10, the tip end side of the plate spring 55 is fixed to the inside of the tip electrode 31 by welding, and the base end side of the plate spring 55 is fixed to the inside of the thin guide tube 10. The axial length of the plate spring 55 is not particularly limited, and is, for example, about 40 to 300 mm. The width of the plate spring 55 is not particularly limited as long as it can be accommodated in the inner cavity of the thin catheter 10. The material of the plate spring 55 is preferably a metal material such as stainless steel, nickel-titanium alloy, or cobalt-nickel alloy, or a polymer material such as fluororesin or polyamide resin.

As shown in fig. 3, the handle 20 includes: a grip 21 formed in a shape that can be gripped by an operator, and an operating head (nob)22 attached to the grip 21 so as to be slidable in an axial direction. When the operator holds the grip 20 configured as described above and slides the operating head 22 in the Y direction in fig. 1, the operating wire 50 is pulled toward the proximal end side, and the distal end portion (flexible portion) of the thin catheter 10 is bent (deflected) in the X direction in fig. 1. That is, the operator can swing the thin catheter 10 by sliding the operating head 22. In the present specification, the term "curve of the thin catheter 10" means that the central axis O of the thin catheter 10 is deformed in a zigzag shape or a continuous curve shape by one or more steps.

The grip 21 and the operating head 22 are made of a synthetic resin such as polycarbonate or Acrylonitrile Butadiene Styrene (ABS).

The operating head 22 has: a first head member 23 through which the thin catheter 10 is inserted, and a second head member 24 coupled to the first head member 23. The operating head 22 is configured such that the proximal end side of the second head member 24 is inserted into the grip 21 in a non-removable state and is slidable in the axial direction relative to the grip 21.

Further, inside the operating head 22 (between the first head member 23 and the second head member 24), the connector unit 100 is housed and held. The detailed configuration of the connector unit 100 will be described later, but simply, the plurality of conductive wires 40 inserted into the thin tubes 10 of the first head member 23 are electrically connected to the FPC board 80 inserted into the second head member 24.

The grip 21 is contoured to form an ergonomic shape that matches the hand of the operator. The grip 21 has a hollow structure with openings at respective ends in the axial direction, and an FPC board 80 extending in the axial direction is housed in the hollow structure. A base-end connector 70 connected to an external device such as a power supply device (a device for high-frequency generation and potential measurement) via a wire is disposed on the base end side of the grip 21.

The FPC board 80 is formed by forming a plurality of conductor layers (metal foils) on an insulating film. The FPC board 80 extends to the position where the operating head 22 is disposed through the inside of the grip 21. The base end side of the FPC board 80 is a terminal having a plurality of circular cores for connecting the lead layer portion on the base end side to the base end side connector 70. On the other hand, the tip end side of the FPC board 80 is formed as a connection region (connector portion) in which an insulating film is peeled off, and is insertable into and removable from an unillustrated insertion port (connector for FPC) provided in the narrow tube 10. Therefore, the plurality of wires 40 and the FPC board 80 (the base end side connector 70) are electrically connected by the connector unit 100.

[ connector Unit ]

Next, the connector unit 100 of the present embodiment will be described with additional reference to fig. 4 to 23.

The main body of the connector unit 100 is composed of: a first crimp cover 110 for arranging the plurality of wires 40, a second crimp cover 140 detachably mounted to the first crimp cover 110 and press-fitted with the plurality of wires 40, an intermediate connector 150 to which the respective wires 40 held by the two crimp covers 110,140 are connected, and a rigid substrate 180 to which the intermediate connector 150 is connected by solder. Hereinafter, for convenience of explanation, the upper side (the proximal end side of the electrode catheter 1) of fig. 4 to 6 will be referred to as "one end side" and the lower side (the distal end side of the electrode catheter 1) of fig. 4 to 6 will be referred to as "the other end side" with reference to the arrangement posture of the connector unit 100 shown in fig. 4 to 6.

As shown in fig. 8 to 11 and the like, the first crimp cover 110 includes: a cover body 111 formed in a substantially disc shape, and a hollow cylindrical portion 112 provided at the center of the other end side of the cover body 111. The first crimp cover 110 is molded using an electrically insulating material such as a synthetic resin. Four engaging grooves 118 for engaging the second crimp cover 140 are provided in a recessed manner on one end side of the cover body 111. Further, four first engaging projections 119 extending in the axial direction and engaging with the side walls of the intermediate connector 150 are provided on one end side of the cover main body 111.

A first insertion hole 113 into which the thin guide tube 10 (the plurality of lead wires 40 and the operation wire 50) is inserted is formed to penetrate in the axial direction at the axial center position of the first pressure contact cover 110. The proximal end portion of the thin catheter 10 is fixed to the middle of the first insertion hole 113, and the plurality of lead wires 40 and the operation wire 50 are pulled out from the proximal end portion through the first insertion hole 113. At the end face on the one end side of the cover body 111, a trimming portion 120 for trimming the plurality of wires 40 pulled out from the first insertion hole 113 into four portions substantially radially outward in the radial direction is provided around (on four sides of) the first insertion hole 113, and the trimming portion 120 at each portion is used for trimming five wires 40.

The rectifying portion 120 is configured to have a plurality of protrusions (protrusion group) standing on one end side of the cover body 111. Hereinafter, as shown in fig. 12, the arrangement direction of the plurality of protrusions in one rectifying portion 120 in the lateral direction is referred to as "column direction", and the arrangement direction in the vertical direction is referred to as "row direction". Therefore, each of the full-line portions 120 is configured to have 18 (3 columns × 6 rows) of projections arranged at predetermined intervals in the column direction and the row direction.

As shown in fig. 12, the entire wire portion 120 includes six first protrusions 121 in a first row, six second protrusions 122 in a second row, and six third protrusions 123 in a third row in order from the inner side to the outer side in the radial direction. Hereinafter, the six first protrusions 121 are also collectively referred to as a "first protrusion group 121G", the six second protrusions 122 are also collectively referred to as a "second protrusion group 122G", and the six third protrusions 123 are also collectively referred to as a "third protrusion group 123G".

Each of the harness-arranging portions 120 has five lead wire accommodating grooves 130 for accommodating the lead wires 40 drawn out radially outward from the first insertion hole 113. As shown in fig. 13, the wire housing groove 130 includes: a first receiving groove 131 provided between the adjacent first protrusions 121, a second receiving groove 132 provided between the adjacent second protrusions 122, and a third receiving groove 133 provided between the adjacent third protrusions 123. The bottom surfaces of the accommodating grooves 131 to 133 are located in the same plane, and the leads 40 can be placed on the bottom surfaces. The width of the groove (width in the column direction) of the wire accommodating groove 130 is slightly larger than the diameter of one wire portion so that the wire 40 accommodated therein does not shake in the width direction of the groove.

Here, an inner concave portion 134 that opens toward one end side of the cover main body 111 is formed between the first protrusion group 121G and the first insertion hole 113.

Further, a fitting recess 135 that opens toward one end side of the cover main body 111 is formed between the first projection group 121G and the second projection group 122G. The fitting recess 135 is provided with a contact insertion groove 136 that divides the bottom surface of the wire accommodating groove 130 in the row direction. Therefore, the wires 40 accommodated in the wire accommodating grooves 130 cross over the contact insertion grooves 136 in the row direction.

Further, an outer concave portion 137 that opens toward one end side of the cover main body 111 is formed between the second projection group 122G and the third projection group 123G. The bottom surface of the outer recess 137 is formed deeper than the bottom surface of the wire accommodating groove 130. Therefore, the lead wires 40 accommodated in the lead wire accommodating groove 130 cross the outer concave 137 in the row direction.

Here, as shown in fig. 14 and the like, in the first protrusion group 121G, the first protrusions 121 having a lower height are arranged outward in the row direction (lateral direction), and the first protrusions 121 having a higher height are arranged inward in the row direction (lateral direction). Therefore, the first protrusion group 121G is formed such that the first protrusions 121 become higher from the outer side (the first protrusions 121 having a lower height) toward the inner side (the first protrusions 121 having a higher height) in the column direction. Therefore, as shown in fig. 14, the lead wire 40 is moved while being kept substantially horizontal from the outer side to the inner side in the column direction by the step difference between the first protrusions 121 adjacent in the column direction, and therefore, it becomes easy to pull the lead wire 40 to abut against the side walls of the first protrusions 121 and position it in the lead wire accommodating groove 130.

The second crimp cover 140 is formed in a rectangular shape in a plan view as shown in fig. 15 and 16. The second pressure contact cover 140 is molded using an electrically insulating material such as a synthetic resin. The second crimp cover 140 is formed to have a size capable of covering the entire wire part 120 of the four portions of the first crimp cover 110 from one end side. The second pressure contact cover 140 has a circular second insertion hole 141 that penetrates in the axial direction at a position (axial center position) aligned with the first insertion hole 113 of the first pressure contact cover 110. Second engaging projections 142 engageable with the engaging recesses 118 of the first pressure contact cover 110 are projected from substantially four corners of the other end side of the second pressure contact cover 140. The second pressure contact cover 140 has fitting openings 143 extending in the direction of each side of the second pressure contact cover 140 from the front surface to the back surface thereof at positions aligned with the fitting recesses 135 of the first pressure contact cover 110, and the fitting openings 143 function as connection ports of the intermediate connector 150.

On the other end side of the second pressure contact cover 140, a rectangular ring-shaped inner rib 144 that is inserted into the inner recess 134 (the inner side of the first protrusion group 121G) of the first pressure contact cover 110, abuts against the lead portion disposed in the inner recess 134, and pushes the inner recess 134 in is provided in a protruding manner around the second insertion hole 141. Further, on the other end side of the second pressure contact cover 140, four outer ribs 145 that are inserted into the outer recesses 137 (between the second projection group 122G and the third projection group 123G) of the first pressure contact cover 110, abut against the lead portions arranged in the outer recesses 137, and push the outer recesses 137 into the outer recesses are provided so as to project in the direction of each side of the second pressure contact cover 140. Therefore, the wire 40 accommodated in the wire accommodating groove 130 is held in a pressed state where the inner rib 144 and the outer rib 145 are pushed in at both positions. At this time, since the outer recessed portion 137 is formed deeper than the wire accommodating groove 130 (the first to third accommodating grooves 131 to 133) as shown in fig. 13 and the like, when the wire 40 is pushed into the outer recessed portion 137 by the outer rib 145, the slack of the wire portion disposed between the inner rib 144 and the outer rib 145 is absorbed in the outer recessed portion 137, and the wire 40 is stretched between the ribs 144,145 without slack (a state suitable for pressure-bonding connection described later).

As shown in fig. 17 to 19, the intermediate connector 150 includes a housing 160 formed in a rectangular shape in plan view, and a plurality of contacts 170 held in a state of being arranged along each side direction of the housing 160.

The case 160 is molded using an electrically insulating material such as a synthetic resin. The housing 160 has a flat plate-like housing body 161 for holding the plurality of contacts 170, and a rectangular frame-like side wall portion 167 provided around the housing body 161. A center hole 162 is formed in the housing main body 161 at a position aligned with the insertion holes 113 and 141 of the pressure contact covers 110 and 140, and penetrates from the front surface to the rear surface in the axial direction. On the other end side of the case body 161, four fitting protrusions 163 extending in the direction of each side of the case body 160 are erected around (on four sides of) the center hole 162. The fitting protrusion 163 is formed to have a size that can be fitted into the fitting recess 135 of the first pressure contact cover 110 and the fitting opening 143 of the second pressure contact cover 140.

In the case body 161, as shown in fig. 20, a contact holding hole 164 for holding the contact 170 is formed. The contact holding hole 164 has an inner holding hole 165 penetrating from the front surface to the back surface of the housing body 161 and opening on one end side and the other end side of the housing body 161 (fitting projection 163), and an outer holding hole 166 opening only on one end side of the housing body 161.

An engagement step portion 168 for engaging the first engagement projection 119 of the first crimp cover 110 is formed in the side wall portion 167. Further, a cylindrical boss 169 for positioning the intermediate connector 150 on the rigid board 180 is provided on one end side of the side wall portion 167.

The contact 170 is formed into a predetermined shape as shown in fig. 21, 22, and the like by applying a press process (punching process, bending process, and the like) to a thin flat plate of a conductive material such as a metal. The contact 170 has: the tip end includes a connecting portion 171 having a two-strand shape (a shape branched into two strands) and extending in the axial direction, a connecting portion 172 connected to the connecting portion 171 and extending in a direction orthogonal to the axial direction, a bent portion 173 connected to the connecting portion 172 and bent into a substantially U-shape, and a lead (lead) portion 174 connected to the bent portion 173 and connected to a terminal 181 on the rigid substrate 180 by solder. The contact 170 is applied with a surface treatment (plating treatment) required for coating a thin film such as gold (Au) thereon on its surface. The connection portion 171 and the bent portion 173 of the contact 170 have press-fitting protrusions 175 formed at both ends in the plate width direction thereof so as to protrude outward, and the connection portion 171 and the bent portion 173 are press-fitted into the inner holding hole 165 and the outer holding hole 166, respectively. The press-fit protrusion 175 bites into the inner surface of each holding

hole

165, 166 when inserted into the holding

hole

165, 166, and functions to prevent removal.

A pair of two-strand-shaped distal end projections 176 are provided at the distal end of the connecting portion 171. Between the pair of distal end projections 176, a pressure contact groove 177 opening toward the other end side (upward in fig. 21) is provided. The crimp groove 177 of each contact 170 is used for crimp connection of the wires 40 held by the two crimp covers 110, 140.

As shown in fig. 23, the lead wire 40 is configured by covering a core wire 41 made of a conductive material such as copper with an insulating coating 42 made of an electrically insulating resin material. The diameter of the wire 40 is preferably on the order of 50 to 200 μm. For example, in the case where the diameter of the wire 40 is about 100 μm, the diameter of the core wire 41 is about 80 μm.

As shown in fig. 17, the distal end projection 176 of each contact 170 is disposed so as to project outward from one end side of the housing main body 161 (the fitting projection 163). Therefore, when the intermediate connector 150 is mounted to the both pressure contact covers 110,140 and the fitting convex portion 163 of the intermediate connector 150 is fitted into the fitting concave portion 135 of the first pressure contact cover 110, the projecting portion (the front end projection 176) thereof is inserted into the contact insertion groove 136, and the wire portion crossing over the contact insertion groove 136 is inserted into the pressure contact groove 177 of the contact 170. At this time, the width of the pressure contact groove 177 of each contact 170 is formed to be slightly smaller than the diameter of the core wire 41, and when the lead wire 40 is inserted into the pressure contact groove 177, the insulation coating 42 of the lead wire 40 is cut by the inner edge of the pressure contact groove 177, so that the core wire portion in a stripped state comes into contact with (pressure contact with) the inner edge of the pressure contact groove 177, and the lead wire 40 is electrically connected to the contact 170.

The rigid board 180 is a hard printed wiring board on which a predetermined wiring pattern is formed. The rigid substrate 180 is formed in a substantially disk shape having substantially the same size as the cover main body 111 of the first pressure contact cover 110. A plurality of terminals 181 to which the plurality of contacts 170 (lead portions 174) of the intermediate connector 150 are connected by soldering are arranged on the other end side of the rigid board 180. In addition, the rigid board 180 has a post hole 183 penetrating from the front surface to the rear surface and into which the positioning post 169 of the intermediate connector 150 is inserted. On the other hand, on the other end side of the rigid board 180, not-shown sockets (jacks) (FPC connectors) connected to the plurality of terminals 181 via not-shown wiring patterns are mounted. By mounting the connector portion of the FPC board 80 to this socket, the FPC board 80 is electrically connected to the rigid board 180. A substrate hole 182 having a rectangular shape in plan view is formed in the center of the rigid substrate 180 so as to penetrate from the front surface to the back surface. The first insertion hole 113 of the first pressure contact cover 110, the second insertion hole 141 of the second pressure contact cover 140, the center hole 162 of the intermediate connector 150, and the base plate hole 182 of the rigid base plate 180 are aligned in the axial direction and communicate with each other, and the biasing mechanism (the operation wire 50) is drawn and wound inside and outside the handle 20 through these holes.

< action >

Next, the operation of the connector unit 100 and the electrode catheter 1 will be described with additional reference to fig. 24 to 29. Hereinafter, a procedure of assembling the connector unit 100 will be described. In order to facilitate understanding of the present embodiment, a part of fig. 24, 26, and 28 is shown as a cross-sectional view, and fig. 25, 27, and 29 show the detailed structure of the cross-sectional portion.

First, the

electrodes

31 and 32 are attached to the thin catheter 10, and a thin catheter assembly (catheter tube assembly) in which the lead wires 40 (20 in the present embodiment) and the operation wire 50 are pulled out from the proximal end portion of the thin catheter 10 is formed, and then the proximal end portion of the thin catheter assembly is fixed to the first pressure contact cover 110 by adhesion. At this time, the lead wire 40 and the operation wire 50 are inserted through the first insertion hole 113 of the first crimp cover 110. Therefore, the lead wire 40 passing through the lumen of the thin catheter 10 is pulled out from the first insertion hole 113 of the first crimp cover 110 to the outside. Then, as shown in fig. 24 and 25, the 20 wires 40 previously wound in a bundle shape are radially expanded from the first insertion hole 113 of the first crimp cover 110 to the outside in the radial direction and accommodated in the respective wire accommodating grooves 130. Accordingly, the conductive wires 40 are distributed to the rectifying portions 120 every five lines, and a total of 20 conductive wires 40 radially extend from the first insertion hole 113. As shown in fig. 25, the lead wires 40 accommodated in the lead wire accommodating grooves 130 are laid across the contact insertion grooves 136 and the outer recessed portions 137 in the radial direction.

Next, as shown in fig. 26 and 27, the first pressure contact cover 110 and the second pressure contact cover 140 are aligned, the engaging recess 118 of the first pressure contact cover 110 is engaged with the second engaging projection 142 of the second pressure contact cover 140, and the second pressure contact cover 140 is attached to the first pressure contact cover 110. At this time, the inner ribs 144 of the second crimp cover 140 are inserted into the inner recesses 134 of the first crimp cover 110, and the outer ribs 145 of the second crimp cover 140 are inserted into the outer recesses 137 of the first crimp cover 110. At this time, the portion of the wire 40 accommodated in the wire accommodating groove 130, which is disposed radially inward, is sandwiched and fixed between the front end surface of the inner rib 144 and the bottom surface of the inner recess 134, and the portion of the wire disposed radially outward is pressed into the outer recess 137 by the front end surface of the outer rib 145, and slack is absorbed. Therefore, the lead portion extending between the two ribs 144,145 is stretched over the contact insertion groove 136 in a state of being held firmly without slack. In a state where the second pressure contact cover 140 is attached to the first pressure contact cover 110, the fitting recess 135 of the first pressure contact cover 110 and the fitting opening 143 of the second pressure contact cover 140 are aligned, and the fitting recess 135 is opened toward one end side (upper side in fig. 27) by the fitting opening 143, so that the fitting projection 163 (distal end projection 176) of the intermediate connector 150 can be accommodated from the one end side.

Then, as shown in fig. 28 and 29, the intermediate connector 150 is attached to the both pressure contact covers 110 and 140 by aligning the positions of the both pressure contact covers 110 and 140 in the connected state and engaging the first engaging projection 119 of the first pressure contact cover 110 with the engaging step portion 168 of the intermediate connector 150. In fig. 28 and 29, the rigid board 180 is omitted for convenience, but the rigid board 180 is actually attached to the other end side of the intermediate connector 150. At this time, the fitting protrusion 163 of the intermediate connector 150 is fitted into the fitting recess 135 of the first crimp cover 110 through the fitting opening 143 of the second crimp cover 140. At this time, since the tip end projection 176 (the pressure contact groove 177) of the contact 170 projects outward from the fitting convex portion 163, the tip end projection 176 is inserted into the contact insertion groove 136 of the fitting concave portion 135. As described above, when the lead wire 40 is laid over the contact insertion groove 136 and the tip end projection 176 is inserted into the contact insertion groove 136, the lead wire 40 enters the crimp groove 177 between the tip end projections 176. At this time, the insulation coating 42 is cut by the inner edge of the pressure contact groove 177, so that the core wire 41 in the stripped state contacts the inner edge of the pressure contact groove 177, and the lead wire 40 is pressure-contacted with the contact 170. Therefore, the

electrodes

31 and 32 to which the leads 40 are connected and the terminals of the base-end connector 70 to which the FPC board 80 is connected are electrically connected (electrically conducted) by the intermediate connector 150, and electric power and/or electric signals can be transmitted and received between the

electrodes

31 and 32 and the base-end connector 70. As described above, the assembled connector unit 100 is fixed to the proximal end of the thin catheter 10 by bonding. Then, by attaching the thin catheter 10 to the handle 20 and connecting the proximal end-side connector 70 to an external power supply device (a device for high-frequency generation and potential measurement) via a wire, the electrode catheter 1 can be operated (high-frequency energization can be performed between the electrode 31 and a counter electrode attached to the body surface of the patient and measurement of the cardiac potential can be performed via the ring-shaped electrode 32) to perform medical actions such as treatment and diagnosis of cardiac arrhythmia.

< effects >

As described above, according to the connector unit 100 and the electrode lead 1 of the present embodiment, when the both pressure contact covers 110 and 140 are coupled to the intermediate connector 150, the respective leads 40 held by the both pressure contact covers 110 and 140 and the respective contacts 170 arranged in the intermediate connector 150 are pressure-connected and electrically conducted, so that the connection operation of the leads 40 can be simply and reliably performed, and the manufacturing cost can be reduced.

Further, according to the connector unit 100 and the electrode catheter 1 of the present embodiment, since the plurality of conductive wires 40, which are originally wound in a bundle shape at the center, are arranged so as to be radially expanded outward, and the plurality of contacts 170 are arranged in a substantially annular shape around the center hole 162 in a manner that enables pressure contact connection with the respective conductive wires 40, the connector unit 100 as a whole can be made smaller as compared with a case where the contacts are arranged only in a straight direction, the connector unit 100 can be arranged in a space-saving manner without being restricted by the internal space of the handle 20, and the degree of freedom in the arrangement position of the connector unit 100 inside the handle 20 and the pulling of the conductive wires 40 can be improved.

In addition, according to the connector unit 100 and the electrode catheter 1 of the present embodiment, since the lead wire accommodating groove 130 is provided in a recessed manner between the plurality of projections arranged around the first insertion hole 113, the plurality of lead wires 40 pulled out from the central insertion hole 113 can be accurately and easily arranged.

In addition, according to the connector unit 100 and the electrode catheter 1 of the present embodiment, since the heights of the adjacent first protrusions 121 are different from each other, the lead wire 40 can be easily positioned to the lead wire accommodating groove 130 formed between the protrusions 121 by the step difference between the protrusions 121, and thus the connection operation of the lead wire 40 can be more easily performed.

In addition, according to the connector unit 100 and the electrode catheter 1 of the present embodiment, the lead wire 40 accommodated in the lead wire accommodating groove 130 is held by the inner ribs 144 and the outer ribs 145, so that the lead wire 40 is not displaced or loosened by a load when it is pressed against the contact 170, and the connection operation of the lead wire 40 can be performed more reliably.

< modification example >

The present invention is not limited to the above-described embodiments, and can be appropriately changed and modified within a range not departing from the gist of the present invention.

For example, in the above-described embodiment, a configuration in which a plurality of (20) contacts are arranged in a rectangular shape around the axis is described as an example, but the present invention is not limited to this configuration, and the arrangement, shape, number, and the like of the contacts are not limited to those in the above-described embodiment, and other arrangements, shapes, numbers, and the like may be adopted. Specific examples thereof may be a ring shape in which a plurality of contact pieces are arranged in a polygonal shape other than a rectangular shape, a ring shape in which a plurality of contact pieces are arranged in a circular or elliptical shape around an axis, or a ring shape in which a plurality of contact pieces are arranged in a peculiar shape having a bent portion and a linear portion. In the above-described embodiment, a configuration in which one wire is connected (pressure-bonded) to one contact is described as an example, but the present invention is not limited to this configuration, and for example, a configuration in which one wire is connected (pressure-bonded) to a plurality of contacts or one wire is connected to a plurality of pressure-bonding grooves formed in one contact may be adopted. Adhesive agent

In the above-described embodiment, an electric wire in which a core wire is covered with an insulating coating is described as an example of the wire, but the present invention is not limited to this configuration, and other electric wires such as a coaxial wire may be used. Further, various conductors such as copper, copper alloy, aluminum alloy, and the like can be used as the material of the core wire. Further, the material of the core wire may be subjected to surface treatment such as tin plating. In this case, the core may be formed of a single wire or a twisted wire. On the other hand, the insulating coating material is preferably an insulating synthetic rubber such as nitrile rubber (nitrile rubber), or an insulating synthetic resin such as polyvinyl chloride (PVC) or polypropylene (PP). The insulating coating material may contain additives such as flame retardants, fillers, and colorants.

In the above-described embodiment, a configuration in which a plurality of projections (projection groups) are arranged in the first crimp cover of the connector unit is described as an example, but the arrangement, shape, number, and the like of the projections are not limited to those in the above-described embodiment, and other arrangements, shapes, numbers, and the like may be adopted. For example, although the configuration in which the first to third protrusions having different arrangement shapes are arranged is described in the above embodiment, the configuration is not limited to this, and a configuration in which protrusions having the same shape are arranged may be adopted.

In the above-described embodiment, the configuration in which the connector unit is disposed inside the operating head of the handle is described as an example, but the configuration is not limited to this, and the connector unit may be disposed at another position inside the handle. In other words, the position of the connector unit is not particularly limited as long as the lead wires can be electrically connected to the FPC board (base end connector).

In the above-described embodiment, the configuration in which the electrodes (tip electrode, ring electrode) are disposed at the tip portion (the distal end and the region near the distal end) of the thin catheter is described as an example, but the arrangement, shape, number, and the like of the electrodes are not limited to those exemplified in the above-described embodiment, and other arrangements, shapes, numbers, and the like may be adopted. For example, the tip portion of the thin catheter may be formed in a substantially circular loop shape. The tip of the narrow tube may be formed in a basket shape (spherical or egg shape) by providing a plurality of arc-shaped arms (spine) at equal intervals in the circumferential direction around the core material and joining the core material and both ends of each arm in the axial direction. Further, the tip of the thin catheter may be branched into a plurality of branches, and the tip of each branch may be a free end.

In the above-described embodiment, the sliding type handle in which the operation head is slid in the axial direction with respect to the handle to bend (deflect) the thin catheter is described as an example, however, the present invention is not limited to this configuration, and for example, (A) a dial ring (dial) disposed around the grip may be rotated around a rotation axis coaxial with the center axis of the thin catheter, a dial-type handle for bending the thin catheter in this way, (B) a dial-type handle having a rotation axis orthogonal to the central axis of the thin catheter and configured to rotate a dial disposed on a grip around the rotation axis to bend the thin catheter, or (C) a push-rod type handle or the like that performs an operation of bending the narrow tube by sliding a push rod (lever) disposed on the grip in a predetermined direction.

In the above-described embodiment, the electrode catheter provided with the biasing mechanism (e.g., the operation wire, the plate spring, or the like) for bending the distal end portion of the thin catheter in a predetermined direction (e.g., the X direction in fig. 1) in accordance with the operation of the handle is exemplified, but the electrode catheter is not limited to this configuration, and for example, an electrode catheter provided with a rod spring as a spring member, an electrode catheter provided with the biasing mechanism without using a spring member, or an electrode catheter without the biasing mechanism may be used. However, even in the case of an electrode catheter having no deflection mechanism, the thin catheter itself is preferably flexible and can be appropriately deformed (bent) in accordance with the shape of the insertion path, the diagnosis site, the treatment site, and the like. In this case, the operation wire, the plate spring, and the like are not required, and the shape of the handle (that is, only the grip) may be different.

In the above-described embodiment, the electrode catheter (so-called cautery catheter) used for treatment of arrhythmia and the like is described as an example of the medical device, but the present invention is not limited to this configuration, and an electrode catheter (so-called EP catheter) used for diagnosis of arrhythmia and the like, and a catheter (so-called intraventricular atrial fibrillation catheter) used for removal of atrial fibrillation may be used as the medical device.

In addition to medical instruments used for examination (diagnosis) and treatment of the heart, the present invention is also applicable to other medical instruments such as an esophageal catheter for measuring the temperature inside the esophagus and a cauterization catheter for cauterizing and removing a lesion such as a tumor tissue. The cauterization catheter is inserted into the trachea to cauterize a target site for the treatment of lung diseases such as lung cancer.

The connector unit may be applied to various electric apparatuses other than medical instruments. Examples of the electric devices include various electric devices such as those used in production plants and the like, those used in homes, and those used in offices.

Description of the reference numerals

1 electrode catheter (medical instrument)

10 thin conduit (pipe component)

20 handle (operating component)

31 front electrode (electrode)

32 Ring electrode (electrode)

40 conductor (electric conductor)

70 base end connector (connection object)

80 FPC substrate (connection object)

100 connector unit (connector)

110 first press cover (first connector cover)

120 whole line part

121 first projection

122 second projection

123 third projection

130 wire storage groove (wire storage part)

140 second crimp cover (second connector cover)

144 inner side convex rib (wire holding part)

145 outside convex rib (wire holding part)

150 middle connector

160 casing (connector shell)

170 contact

176 front end projection

177 crimping groove

180 rigid substrate.

Claims

1. A catheter is provided with:

a thin catheter member having at least one lumen;

a plurality of electrodes mounted to the thin catheter member;

a plurality of electrical leads configured to extend axially within the lumen of the thin catheter member and have respective distal ends connected to respective ones of the plurality of electrodes;

an operating member coupled to a base end side of the thin catheter member; and

a connector for electrically connecting the plurality of electric wires to a connection object provided on the operation member and allowing transmission and reception of electric power and/or electric signals between the plurality of electric wires and the connection object,

wherein the connector comprises:

a connector cover member for radially extending and accommodating each of a plurality of electric wires wound in a bundle shape at the center;

a connector housing member coupled with the connector cover member; and

a plurality of contacts arranged substantially in a ring around a central portion of the connector housing member, wherein

The connector is configured to: when the connector cover member is combined with the connector shell member, the plurality of electric leads are respectively connected with the plurality of contact pieces in a pressure welding way;

the connector cover member is configured to have a plurality of protrusions and a plurality of wire accommodating portions formed between the adjacent protrusions in a concave shape so as to radially expand and accommodate each of the plurality of electrical wires;

the connector cover member is formed such that the adjacent protrusions have different heights.

2. The catheter of claim 1,

the connector cover member has a first connector cover member coupled with the connector housing member, and a second connector cover member detachably mounted to the first connector cover member, wherein

The first connector cover member has the plurality of wire receiving portions formed between the adjacent protrusions,

the second connector cover member has a wire holding portion that abuts against the plurality of electrical wires accommodated in the plurality of wire accommodating portions to hold the plurality of electrical wires.