WO2013141011A1 - Medical tube control handle and medical tube device - Google Patents

Medical tube control handle and medical tube device Download PDF

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Publication number
WO2013141011A1
WO2013141011A1 PCT/JP2013/055947 JP2013055947W WO2013141011A1 WO 2013141011 A1 WO2013141011 A1 WO 2013141011A1 JP 2013055947 W JP2013055947 W JP 2013055947W WO 2013141011 A1 WO2013141011 A1 WO 2013141011A1
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WO
WIPO (PCT)
Prior art keywords
control handle
tube
handle
distal end
grip
Prior art date
Application number
PCT/JP2013/055947
Other languages
French (fr)
Japanese (ja)
Inventor
小林　洋平
Original Assignee
日本ライフライン株式会社
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Filing date
Publication date
Application filed by 日本ライフライン株式会社 filed Critical 日本ライフライン株式会社
Publication of WO2013141011A1 publication Critical patent/WO2013141011A1/en

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    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M25/00—Catheters; Hollow probes
    • A61M25/01—Introducing, guiding, advancing, emplacing or holding catheters
    • A61M25/0105—Steering means as part of the catheter or advancing means; Markers for positioning
    • A61M25/0133—Tip steering devices
    • A61M25/0136—Handles therefor

Definitions

  • the present invention relates to a medical tube control handle and a medical tube device including the same.
  • a sheath tube (steerable sheath) is first introduced into the body to secure an insertion path for the medical device. ing.
  • Patent Document 1 discloses a shaft (sheath tube) having a deflectable portion and a lumen, and a control handle having a deflection assembly (rotation operation unit).
  • a sheath guiding device is disclosed that includes a deflectable portion and a tension member extending between the control handle.
  • FIG. 6 is a plan view showing a conventionally known sheath device.
  • the sheath apparatus shown in the figure includes a sheath tube 60 having a distal end flexible portion 60A, and a control handle 70 in which a proximal end portion of the sheath tube 60 is inserted (connected to the proximal end side of the sheath tube 60).
  • a branch pipe (side arm) 75 connected to the control handle 70 and having an inner hole communicating with the inner hole of the sheath tube 60, and a three-way stopcock 76 attached to the branch pipe 75.
  • the control handle 70 constituting the sheath device is provided on a handle main body 71 (grip part), a rotary plate 72 (rotation operation part) positioned on the distal end side of the handle main body 71, and a proximal end side of the handle main body 71.
  • a hemostasis valve 73 and a strain relief 74 located on the distal end side of the rotating plate 72 are provided.
  • the proximal end portion of the sheath tube 60 is inserted into the inside of the control handle 70 (handle body 71), and the proximal end of the sheath tube 60 is connected to the hemostasis valve 73.
  • the sheath tube 60 As a method of introducing the sheath tube 60 into the body using the sheath device as shown in FIG. 6, the sheath tube 60 is inserted into a patient's blood vessel together with a dilator (not shown), and the guide wire inserted in advance is used. And move it toward the target site (affected area).
  • the introduction operation of the sheath tube 60 is performed while appropriately operating the rotating plate 72 of the control handle 70 (while appropriately deflecting the distal end of the sheath tube 60).
  • a guide wire and a dilator are extracted. Thereby, the front-end
  • the distal end of the catheter shaft 80 is connected to the proximal end (the hemostatic valve 73) of the control handle 70 as shown in FIG. ) Is inserted into the inner hole of the sheath tube 60, the catheter shaft 80 is moved along the inner hole, and the distal end flexible portion 80A of the catheter shaft 80 is extended from the distal end opening of the sheath tube 60.
  • the insertion operation of the catheter shaft 80 is performed while appropriately operating the rotation plate 92 (rotation operation portion) of the control handle 90 connected to the proximal end of the catheter shaft 80 (while appropriately deflecting the distal end of the catheter shaft 80). ) Done.
  • the distal end portion of the catheter shaft 80 (for example, the electrode in the electrode catheter) is positioned at the target site (affected site).
  • the operation of the rotating plate 92 (the tip deflection operation of the catheter shaft 80) is performed, for example, with the thumb and index finger of the right hand while holding the handle body 91 of the control handle 90 with the right hand (dominant hand) as shown in FIG. Is called.
  • the catheter shaft 80 inserted from the proximal end (the hemostasis valve 73) of the handle body 71 into the inner hole of the sheath tube 60 in which the proximal end portion is inserted into the handle body 71.
  • the catheter 90 is operated by operating the rotary plate 92 of the control handle 90 in order to position the distal end portion of the catheter shaft 80 at the target site.
  • the position of the distal end opening of the sheath tube 60 is changed by operating the rotating plate 72 of the control handle 70 to bend the distal end flexible portion 60A of the sheath tube 60. (Fine adjustment) may be desired.
  • the handle main body 71 related to the sheath tube 60 is changed to the right hand (the handle main body 91 related to the catheter shaft 80 is changed to the left hand), and the right hand thumb and index finger are changed.
  • the handle main body 91 related to the catheter shaft 80 is changed to the left hand
  • the right hand thumb and index finger are changed.
  • the operation of changing the control handle is complicated, and when the control handle is changed, the distal end portion of the catheter shaft 80 may be displaced. Further, it is required by a skilled operator that the distal end deflection operation of the catheter shaft 80 and the distal end deflection operation of the sheath tube 60 can be performed simultaneously (or alternately), but the sheath as shown in FIGS.
  • the tip deflection operation of the catheter shaft 80 by the rotating plate 92 of the control handle 90 and the rotation of the control handle 70 are performed.
  • the tip deflection operation of the sheath tube 60 by the plate 72 cannot be performed simultaneously (or alternately). Although it is possible to hold the handle body 71 with the left hand in the opposite hand and perform the tip deflection operation, the operation is difficult and the operation may be wrong.
  • a first object of the present invention is to provide a control handle capable of operating a rotation operation unit (operation for deflecting the tip of a tube) by holding it with either left or right hand.
  • the second object of the present invention is to control the tip deflection operation of a tube introduced into the body prior to the medical instrument even after the distal deflection operation of a long medical instrument such as a catheter is performed. It is an object of the present invention to provide a medical tube control handle that can be implemented without changing the handle.
  • a third object of the present invention is to simultaneously or alternately perform the tip deflection operation of a long medical instrument such as a catheter and the tip deflection operation of a tube introduced into the body prior to the medical instrument.
  • the fourth object of the present invention is to operate the rotary operation unit by grasping the control handle with either the left or right hand, and after performing the tip deflection operation of a long medical instrument such as a catheter.
  • Another object of the present invention is to provide a medical tube device that can perform the tip deflection operation of the tube without changing the control handle even when the tip deflection operation is being performed.
  • the medical tube control handle of the present invention is provided with a handle main body into which a proximal end portion of the tube having a distal end flexible portion is inserted, and is rotatable with respect to the handle main body.
  • a rotation operation unit that deflects the distal end of the tube by bending the distal end flexible portion of the tube,
  • the handle main body includes a first grip portion located on a proximal end side of the rotation operation portion and a second grip portion located on a distal end side of the rotation operation portion.
  • the rotary operation unit is operated with the thumb and index finger of one hand by grasping the first grip part of the handle body with either one of the left and right hands.
  • the tip deflection operation of the tube can be performed.
  • the rotation operation portion is operated with the thumb and index finger of the other hand to perform the tip deflection operation of the tube.
  • the proximal end portion of the sheath tube having the distal end flexible portion is provided therein, and is provided rotatably with respect to the handle body. Is provided at the proximal end of the handle body, and is provided at the proximal end of the handle body. It is preferable to comprise a hemostasis valve to which the proximal end is connected.
  • the handle body (grip part) of the control handle of a long medical instrument such as a catheter is gripped with one hand, and the rotary operation part located on the distal end side thereof
  • the handle body (second grip portion) of the control handle of the present invention is gripped with the other hand when the thumb is operated with the thumb and index finger of the one hand (the tip deflection operation of the medical device)
  • the rotation operation part located on the proximal end side can be operated (the distal end deflection operation of the sheath tube) with the thumb and index finger of the other hand.
  • the first grip and the second grip have the same shape.
  • “the same shape as each other” includes the case where both shapes (dimensions) are completely the same and the shapes are almost the same.
  • the first grip is cylindrical and the second grip is also cylindrical, or when the first grip is rectangular (prism) and the second grip is rectangular (prism), Even if the lengths of the two are slightly different, the two have the same shape. According to the control handle of the present invention having such a configuration, the same operational feeling can be obtained when either the first grip or the second grip is gripped.
  • the first grip and the second grip have a diameter reduced toward a center where the rotation operation unit is located. According to the control handle of the present invention having such a configuration, when the first grip or the second grip is gripped, the grip can be easily gripped, and the rotation operation unit can be operated smoothly.
  • the rotation operation unit is rotatable around an axis orthogonal to the longitudinal direction of the handle body.
  • the rotation operation unit may be rotatable around a longitudinal axis of the handle body.
  • a medical tube device includes the control handle according to any one of (1) to (6) above, And a tube having a distal end flexible portion and having a proximal end portion inserted into the inside of the handle main body of the control handle.
  • the rotation operation section (tube tip deflection operation) can be performed. Even after the tip deflection operation of a long medical instrument such as a catheter is performed, the tip deflection operation of the tube introduced into the body prior to the medical instrument is changed by changing the control handle of the tube. Can be implemented without. Furthermore, the tip deflection operation of a long medical instrument such as a catheter and the tip deflection operation of a tube introduced into the body prior to the medical instrument can be performed simultaneously or alternately.
  • the rotation operation unit can be operated by holding the control handle with either the left or right hand, and the tip deflection operation of a long medical instrument such as a catheter can be performed. After or after the operation, the tube tip deflection operation can be performed without changing the control handle.
  • FIG. 1 It is a top view which shows the medical tube apparatus (sheath apparatus) provided with the control handle which concerns on one Embodiment of this invention. It is a perspective view which shows the control handle (control handle which concerns on one Embodiment of this invention) which comprises the sheath apparatus shown in FIG. It is a top view which shows the state by which the catheter shaft is penetrated by the inner hole of the sheath tube which comprises the sheath apparatus shown in FIG. It is a top view which shows the state which is operating the rotation operation part of the control handle (control handle which concerns on one Embodiment of this invention) which comprises the sheath apparatus shown in FIG. 1, and the rotation operation part of the control handle of a catheter shaft. .
  • FIG. 8 is a plan view showing a state in which the rotation operation portion of the control handle of the catheter shaft is operated in the state shown in FIG. 7.
  • a medical tube device (sheath device) 100 shown in FIGS. 1 to 4 is a device for introducing the sheath tube 10 into the body prior to the insertion of the catheter shaft 80 into the body of the patient.
  • the sheath device 100 includes a sheath tube 10, a control handle 20, a branch pipe (side arm) 31, and a three-way cock 32.
  • a control handle 20 constituting the sheath device 100 includes a handle body 21 into which a proximal end portion of the sheath tube 10 having a distal end flexible portion 10A is inserted, and the handle body 21.
  • a rotation plate 22 (rotation operation part) that deflects the distal end flexible portion 10A and deflects the distal end of the sheath tube 10 by operating this, and is provided on the proximal end side of the handle body 21;
  • the handle main body 21 includes a hemostasis valve 23 to which the proximal end of the sheath tube 10 is connected.
  • the handle main body 21 includes a first grip portion 211 positioned on the proximal end side of the rotating plate 22 and the rotating plate 22. 2nd grip part 212 located in the front end side.
  • the tip region of the sheath tube 10 constituting the sheath device 100 is a tip flexible portion 10A.
  • the “tip flexible portion” refers to the tip portion of the tube that can be bent (bent) by operating the rotation operation portion.
  • the sheath tube 10 is configured by a hollow tube member made of a synthetic resin such as polyolefin, polyamide, polyether polyamide, or polyurethane.
  • the outer diameter of the sheath tube 10 is usually 2.0 to 5.0 mm, preferably 2.6 to 4.3 mm.
  • the inner diameter of the sheath tube 10 is usually 1.6 to 4.3 mm, preferably 2.0 to 2.8 mm.
  • the length of the sheath tube 10 is, for example, 500 to 800 mm, and the length of the distal end flexible portion 10A is, for example, 20 to 150 mm.
  • the control handle 20 constituting the sheath device 100 includes a handle body 21, a rotating plate 22, and a hemostasis valve 23.
  • the proximal end portion of the sheath tube 10 is inserted into the handle main body 21 of the control handle 20.
  • the rotating plate 22 of the control handle 20 is provided so as to be rotatable with respect to the handle body 21 around an axis perpendicular to the longitudinal direction of the handle body 21.
  • a first operation wire (not shown) for bending the distal flexible portion 10A in the first direction (the direction indicated by arrow A in FIG. 1) and the distal flexible portion 10A are second.
  • a second operation wire (not shown) for bending in a direction (a direction indicated by an arrow B in FIG. 1) extends.
  • the distal ends of the first operation wire and the second operation wire are connected and fixed to the distal end portion of the sheath tube 10.
  • the rear ends of the first operation wire and the second operation wire are connected to the rotating plate 22 of the control handle 20 so that the pulling operation can be performed.
  • the distal end flexible portion 10A When the rotating plate 22 is rotated in the A1 direction shown in FIG. 1, the distal end flexible portion 10A is bent in the first direction (the direction indicated by the arrow A in FIG. 1) by pulling the first operation wire, and the sheath. The tip of the tube 10 is deflected in the first direction.
  • the rotating plate 22 When the rotating plate 22 is rotated in the B1 direction shown in FIG. 1, the distal end flexible portion 10A is bent in the second direction (the direction indicated by the arrow B in FIG. 1) by pulling the second operation wire. The tip of the sheath tube 10 is deflected in the second direction.
  • the directions of the A direction and the B direction with respect to the control handle 20 can be freely set.
  • the handle main body 21 of the control handle 20 has two grip portions (a first grip 211 located on the proximal end side and a first grip located on the distal end side) disposed on both sides of the rotating plate 22 (rotation operation portion). 2 grip 212).
  • the control handle 20 having grips on both sides of the rotating plate 22, by holding the first grip portion 211 of the handle body 21 with either one of the left and right hands (for example, the right hand), the one hand (for example, the rotating plate 22 can be operated with the thumb and index finger of the right hand (the tip deflection operation of the sheath tube 10 can be performed). Further, by grasping the second grip 212 of the handle body 21 with either the left or right hand (for example, the left hand), the rotating plate 22 can be operated with the thumb and index finger of the other hand (for example, the left hand) (sheath) The tip 10 of the tube 10 can be deflected).
  • the control handle 20 even when the handle body 21 is gripped with either the left or right hand, by selecting the grip that can be gripped so that the rotating plate 22 is positioned on the thumb side, The distal end of the sheath tube 10 can be deflected by operating the rotary plate 22 with the thumb and index finger of the hand holding the grip.
  • the first grip 211 and the second grip 212 constituting the handle body 21 have the same shape. Thereby, even when any grip is gripped and the rotary plate 22 is operated, the same operational feeling can be obtained. Further, both the first grip 211 and the second grip 212 are reduced in diameter toward the center where the rotary plate 22 is located. Thereby, when gripping any grip and operating the rotating plate 22, the grip is easy to grip and the rotating plate 22 can be operated smoothly.
  • the hemostasis valve 23 provided at the proximal end of the handle body 21 (first grip portion 211) has liquid tightness, and the sheath tube 10 whose proximal end is connected to the hemostasis valve 23 inside the handle body 21. It is possible to prevent liquid (such as blood or a chemical solution supplied from the branch pipe 31) existing in the inner hole from leaking out from the base end of the control handle 20.
  • the hemostasis valve 23 is made of, for example, an elastomer sheet in which slits penetrating both surfaces are formed.
  • the inner hole of the branch pipe 31 constituting the sheath device 100 communicates with the inner hole of the sheath tube 10, and the chemical solution or the like supplied from the branch pipe 31 is supplied into the body through the inner hole of the sheath tube 10. be able to.
  • the sheath tube 10 constituting the sheath device 100 can be introduced into the patient's body.
  • a dilator (not shown) is inserted into the inner hole of the sheath tube 10
  • the sheath tube 10 integrated with the dilator is inserted into the blood vessel of the patient, and the rotating plate of the control handle 20 is inserted.
  • the sheath tube 10 is moved toward the target site (affected site) along the guide wire that is inserted in advance while performing the tip deflection operation.
  • the distal end opening of the sheath tube 10 reaches the vicinity of the target site (affected site), the dilator and the guide wire are removed. Thereby, the front-end
  • the catheter shaft can be inserted into the body using the sheath tube 10 thus introduced into the body.
  • the distal end of the catheter shaft 80 is inserted into the inner hole of the sheath tube 10 from the proximal end (the hemostatic valve 23) of the control handle 20, and the rotating plate 92 of the control handle 90 is inserted.
  • the catheter shaft 80 is moved along the inner hole of the sheath tube 10, and the tip flexible portion 80A of the catheter shaft 80 is extended from the tip opening of the sheath tube 10.
  • the distal end of the catheter shaft 80 is deflected by operating the rotating plate 92 of the control handle 90 to bend the distal end flexible portion 80A, and the rotating plate 22 of the control handle 20 is operated as necessary.
  • the distal end of the sheath tube 10 is deflected by bending the distal flexible portion 10A. Thereby, the position of the distal end portion of the catheter shaft 80 (for example, an electrode in the electrode catheter) is adjusted, and this can reach the target site (affected site).
  • the operation of the rotating plate 92 for deflecting the distal end of the catheter shaft 80 is performed by the right thumb and index finger holding the handle body 91 of the control handle 90 to deflect the distal end of the sheath tube 10.
  • the operation of the rotary plate 22 is performed by the left thumb and index finger holding the second grip 212 of the control handle 20.
  • a catheter procedure (diagnosis / treatment) is performed. After completion of the catheter procedure, the catheter shaft 80 is removed from the body, and then the sheath tube 10 is removed from the body.
  • FIG. 5 shows a control handle according to another embodiment of the present invention.
  • the control handle 25 is provided with a handle main body 26 into which the proximal end portion of the sheath tube 10 is inserted, and is rotatable with respect to the handle main body 26.
  • the rotary operation part 27 which deflects a part and deflects the front-end
  • the same components as those in the first embodiment are denoted by the same reference numerals.
  • the rotation operation unit 27 constituting the control handle 25 is provided so as to be rotatable around the longitudinal axis of the handle body 26.
  • the rotation operation unit 27 is rotated in the a1 direction shown in FIG. 5, the distal flexible portion of the sheath tube 10 is bent in the first direction, and the distal end of the sheath tube 10 is deflected in the first direction.
  • the rotation operation unit 27 is rotated in the b1 direction shown in FIG. 5, the distal end flexible portion of the sheath tube 10 is bent in the second direction opposite to the first direction, and the distal end of the sheath tube 10 is the second. Deflect in the direction.
  • the handle main body 26 constituting the control handle 25 has a first grip part 261 located on the proximal end side of the rotation operation part 27 and a second grip part 262 located on the distal end side of the rotation operation part 27. .
  • the first grip portion 261 of the handle body 26 is held by either one of the left and right hands (for example, the right hand), thereby
  • the rotation operation unit 27 can be operated with the thumb (for example, the right hand) and the index finger (the tip deflection operation of the sheath tube 10 is performed).
  • the rotation operation unit 27 is operated with the thumb and index finger of the other hand (for example, the left hand) (sheath)
  • the tip of the tube 10 can be deflected).
  • the tube to which the control handle of the present invention is attached is not limited to a sheath tube, and may be a catheter shaft that is directly used for diagnosis and treatment.

Abstract

A control handle provided with: a main handle body (21) into the interior of which the base end portion of a sheath tube (10) with a flexible tip portion (10A) is inserted; a rotating plate (22), which is provided so as to be rotatable with respect to the main handle body (21) and which bends the flexible tip portion (10A) of the sheath tube (10) by operation thereof to steer the tip of the sheath tube (10); and a hemostasis valve (23) provided on the base end of the main handle body (21). The main handle body (21) has a first grip section (211) located on the base end side of the rotating plate (22) and a second grip section (213) located on the leading end side of the rotating plate (22). With said control handle, operation of the rotation-operating section (steering of the tube tip) can be performed whether grasped with the left or right hand.

Description

医療用チューブの制御ハンドルおよび医療用チューブ装置Medical tube control handle and medical tube device
　本発明は医療用チューブの制御ハンドルおよびこれを備えた医療用チューブ装置に関する。 The present invention relates to a medical tube control handle and a medical tube device including the same.
　従来、カテーテルなどの長尺の医療器具を患者の体内に挿入する際に、シースチューブ（ステアラブルシース）を先行して体内に導入して、この医療器具の挿通路を確保することが行われている。 Conventionally, when a long medical device such as a catheter is inserted into a patient's body, a sheath tube (steerable sheath) is first introduced into the body to secure an insertion path for the medical device. ing.
　体内に挿入するシースチューブを備えたシース装置として、下記特許文献１には、偏向可能な部分および内腔を有するシャフト（シースチューブ）と、偏向用組立品（回転操作部）を有する制御ハンドルと、偏向可能な部分と制御ハンドルとの間を延びる引張部材とを含むシース誘導機器が開示されている。 As a sheath device provided with a sheath tube to be inserted into the body, the following Patent Document 1 discloses a shaft (sheath tube) having a deflectable portion and a lumen, and a control handle having a deflection assembly (rotation operation unit). A sheath guiding device is disclosed that includes a deflectable portion and a tension member extending between the control handle.
　図６は、従来公知のシース装置を示す平面図である。同図に示すシース装置は、先端可撓部分６０Ａを有するシースチューブ６０と、このシースチューブ６０の基端部分が内部に挿入された（シースチューブ６０の基端側に接続された）制御ハンドル７０と、この制御ハンドル７０に接続され、シースチューブ６０の内孔と連通する内孔を有する枝管（サイドアーム）７５と、この枝管７５に装着された三方活栓７６とを備えている。 FIG. 6 is a plan view showing a conventionally known sheath device. The sheath apparatus shown in the figure includes a sheath tube 60 having a distal end flexible portion 60A, and a control handle 70 in which a proximal end portion of the sheath tube 60 is inserted (connected to the proximal end side of the sheath tube 60). A branch pipe (side arm) 75 connected to the control handle 70 and having an inner hole communicating with the inner hole of the sheath tube 60, and a three-way stopcock 76 attached to the branch pipe 75.
　シース装置を構成する制御ハンドル７０は、ハンドル本体７１（グリップ部）と、このハンドル本体７１の先端側に位置する回転板７２（回転操作部）と、ハンドル本体７１の基端側に設けられた止血弁７３と、回転板７２の先端側に位置するストレインリリーフ７４とを備えている。
　この制御ハンドル７０（ハンドル本体７１）の内部には、シースチューブ６０の基端部分が挿入されており、シースチューブ６０の基端は、止血弁７３に連結されている。
　制御ハンドル７０の回転板７２を操作することにより、シースチューブ６０の先端可撓部分６０Ａが撓み、この結果、シースチューブ６０の先端を偏向させることができる。 The control handle 70 constituting the sheath device is provided on a handle main body 71 (grip part), a rotary plate 72 (rotation operation part) positioned on the distal end side of the handle main body 71, and a proximal end side of the handle main body 71. A hemostasis valve 73 and a strain relief 74 located on the distal end side of the rotating plate 72 are provided.
The proximal end portion of the sheath tube 60 is inserted into the inside of the control handle 70 (handle body 71), and the proximal end of the sheath tube 60 is connected to the hemostasis valve 73.
By operating the rotating plate 72 of the control handle 70, the distal end flexible portion 60A of the sheath tube 60 bends, and as a result, the distal end of the sheath tube 60 can be deflected.
　図６に示したようなシース装置を用いてシースチューブ６０を体内に導入する方法としては、図示しないダイレータとともにシースチューブ６０を患者の血管内に挿入し、先行して挿入されているガイドワイヤに沿って目的部位（患部）に向けて移動させる。
　ここに、シースチューブ６０の導入操作は、制御ハンドル７０の回転板７２を適宜操作しながら（シースチューブ６０の先端を適宜偏向させながら）行われる。
　そして、シースチューブ６０の先端開口を目的部位（患部）の近傍に到達させた後に、ガイドワイヤおよびダイレータを抜去する。これにより、シースチューブ６０の先端部分が患者の体内に留置される。 As a method of introducing the sheath tube 60 into the body using the sheath device as shown in FIG. 6, the sheath tube 60 is inserted into a patient's blood vessel together with a dilator (not shown), and the guide wire inserted in advance is used. And move it toward the target site (affected area).
Here, the introduction operation of the sheath tube 60 is performed while appropriately operating the rotating plate 72 of the control handle 70 (while appropriately deflecting the distal end of the sheath tube 60).
And after making the front-end | tip opening of the sheath tube 60 reach the vicinity of a target site | part (affected part), a guide wire and a dilator are extracted. Thereby, the front-end | tip part of the sheath tube 60 is detained in a patient's body.
　このようにして体内に導入されたシースチューブ６０を利用してカテーテルシャフトを体内に挿入する方法としては、図７に示すように、カテーテルシャフト８０の先端を制御ハンドル７０の基端（止血弁７３）からシースチューブ６０の内孔に挿入し、この内孔に沿ってカテーテルシャフト８０を移動させ、シースチューブ６０の先端開口からカテーテルシャフト８０の先端可撓部分８０Ａを延び出させる。 As a method of inserting the catheter shaft into the body using the sheath tube 60 introduced into the body in this way, the distal end of the catheter shaft 80 is connected to the proximal end (the hemostatic valve 73) of the control handle 70 as shown in FIG. ) Is inserted into the inner hole of the sheath tube 60, the catheter shaft 80 is moved along the inner hole, and the distal end flexible portion 80A of the catheter shaft 80 is extended from the distal end opening of the sheath tube 60.
　ここに、カテーテルシャフト８０の挿入操作は、カテーテルシャフト８０の基端に接続されている制御ハンドル９０の回転板９２（回転操作部）を適宜操作しながら（カテーテルシャフト８０の先端を適宜偏向させながら）行われる。 Here, the insertion operation of the catheter shaft 80 is performed while appropriately operating the rotation plate 92 (rotation operation portion) of the control handle 90 connected to the proximal end of the catheter shaft 80 (while appropriately deflecting the distal end of the catheter shaft 80). ) Done.
　次に、制御ハンドル９０の回転板９２を操作して、先端可撓部分８０Ａを撓ませることによって、カテーテルシャフト８０の先端部（例えば、電極カテーテルにおける電極）を目的部位（患部）に位置させる。 Next, by operating the rotary plate 92 of the control handle 90 to bend the distal end flexible portion 80A, the distal end portion of the catheter shaft 80 (for example, the electrode in the electrode catheter) is positioned at the target site (affected site).
　回転板９２の操作（カテーテルシャフト８０の先端偏向操作）は、例えば、図８に示すように、制御ハンドル９０のハンドル本体９１を右手（利き手）で把持した状態で、右手の親指および人指し指により行われる。 The operation of the rotating plate 92 (the tip deflection operation of the catheter shaft 80) is performed, for example, with the thumb and index finger of the right hand while holding the handle body 91 of the control handle 90 with the right hand (dominant hand) as shown in FIG. Is called.
特開２０１０－１５５０８１号公報JP 2010-155081 A
　図７に示した状態、すなわち、ハンドル本体７１の内部にその基端部分が挿入されているシースチューブ６０の内孔に、ハンドル本体７１の基端（止血弁７３）から挿入させたカテーテルシャフト８０におけるその先端可撓部分８０Ａを、シースチューブ６０の先端開口から延び出させた状態において、カテーテルシャフト８０の先端部を目的部位に位置させるために、制御ハンドル９０の回転板９２を操作してカテーテルシャフト８０の先端可撓部分８０Ａを撓ませることに加え、制御ハンドル７０の回転板７２を操作してシースチューブ６０の先端可撓部分６０Ａを撓ませてシースチューブ６０の先端開口の位置などを変化（微調整）させたい場合がある。 In the state shown in FIG. 7, that is, the catheter shaft 80 inserted from the proximal end (the hemostasis valve 73) of the handle body 71 into the inner hole of the sheath tube 60 in which the proximal end portion is inserted into the handle body 71. In the state where the distal end flexible portion 80A of the catheter tube 80 extends from the distal end opening of the sheath tube 60, the catheter 90 is operated by operating the rotary plate 92 of the control handle 90 in order to position the distal end portion of the catheter shaft 80 at the target site. In addition to bending the distal end flexible portion 80A of the shaft 80, the position of the distal end opening of the sheath tube 60 is changed by operating the rotating plate 72 of the control handle 70 to bend the distal end flexible portion 60A of the sheath tube 60. (Fine adjustment) may be desired.
　しかしながら、図８に示すように、カテーテルシャフト８０の制御ハンドル９０のハンドル本体９１（グリップ部）を右手で把持して、右手の指で回転板９２を操作しているときには、シースチューブ６０の制御ハンドル７０のハンドル本体（グリップ部）７１を左手で把持しているため、ハンドル本体７１の先端側（ハンドル本体７１を把持する左手の小指側）に位置する回転板７２を、左手の親指および人指し指で操作することはできない。
　このため、制御ハンドル７０の回転板７２を操作するためには、シースチューブ６０に係るハンドル本体７１を右手に持ち替えて（カテーテルシャフト８０に係るハンドル本体９１を左手に持ち替えて）右手の親指および人指し指で操作しなければならない。 However, as shown in FIG. 8, when the handle main body 91 (grip part) of the control handle 90 of the catheter shaft 80 is gripped with the right hand and the rotating plate 92 is operated with the finger of the right hand, the control of the sheath tube 60 is performed. Since the handle main body (grip part) 71 of the handle 70 is held with the left hand, the rotating plate 72 positioned on the distal end side (the little finger side of the left hand holding the handle main body 71) is placed on the left hand thumb and the index finger. It cannot be operated with.
Therefore, in order to operate the rotating plate 72 of the control handle 70, the handle main body 71 related to the sheath tube 60 is changed to the right hand (the handle main body 91 related to the catheter shaft 80 is changed to the left hand), and the right hand thumb and index finger are changed. Must be operated with.
　然るに、制御ハンドルを持ち替える操作は煩雑であり、また、制御ハンドルを持ち替えたときに、カテーテルシャフト８０の先端部が位置ずれを起こすこともある。
　更に、カテーテルシャフト８０の先端偏向操作と、シースチューブ６０の先端偏向操作とを同時に（あるいは交互に）実施できることが、熟練したオペレータによって要請されるが、図６～図８に示したようなシース装置を使用し、図８に示したようにハンドル本体７１を、左手を順手にして把持する場合には、制御ハンドル９０の回転板９２によるカテーテルシャフト８０の先端偏向操作と、制御ハンドル７０の回転板７２によるシースチューブ６０の先端偏向操作とを同時（あるいは交互に）に行うことはできない。
　なお、左手を逆手にしてハンドル本体７１を把持して先端偏向操作することは可能であるが、操作が困難であり、また操作を誤る場合もある。 However, the operation of changing the control handle is complicated, and when the control handle is changed, the distal end portion of the catheter shaft 80 may be displaced.
Further, it is required by a skilled operator that the distal end deflection operation of the catheter shaft 80 and the distal end deflection operation of the sheath tube 60 can be performed simultaneously (or alternately), but the sheath as shown in FIGS. When the handle main body 71 is gripped with the left hand as shown in FIG. 8 using the apparatus, the tip deflection operation of the catheter shaft 80 by the rotating plate 92 of the control handle 90 and the rotation of the control handle 70 are performed. The tip deflection operation of the sheath tube 60 by the plate 72 cannot be performed simultaneously (or alternately).
Although it is possible to hold the handle body 71 with the left hand in the opposite hand and perform the tip deflection operation, the operation is difficult and the operation may be wrong.
　本発明は以上のような事情に基いてなされたものである。
　本発明の第１の目的は、左右何れの手で把持することによっても、回転操作部の操作（チューブの先端偏向操作）を行うことができる制御ハンドルを提供することにある。
　本発明の第２の目的は、カテーテルなどの長尺の医療器具の先端偏向操作を行った後であっても、この医療器具に先行して体内に導入させたチューブの先端偏向操作を、制御ハ
ンドルを持ち替えることなく実施することができる医療用チューブの制御ハンドルを提供することにある。
　本発明の第３の目的は、カテーテルなどの長尺の医療器具の先端偏向操作と、この医療器具に先行して体内に導入させたチューブの先端偏向操作とを同時または交互に実施することができる医療用チューブの制御ハンドルを提供することにある。
　本発明の第４の目的は、左右何れの手で制御ハンドルを把持することによっても、回転操作部の操作を行うことができ、カテーテルなどの長尺の医療器具の先端偏向操作を行った後または先端偏向操作を行っているときであっても、制御ハンドルを持ち替えることなくチューブの先端偏向操作を実施することができる医療用チューブ装置を提供することにある。 The present invention has been made based on the above situation.
A first object of the present invention is to provide a control handle capable of operating a rotation operation unit (operation for deflecting the tip of a tube) by holding it with either left or right hand.
The second object of the present invention is to control the tip deflection operation of a tube introduced into the body prior to the medical instrument even after the distal deflection operation of a long medical instrument such as a catheter is performed. It is an object of the present invention to provide a medical tube control handle that can be implemented without changing the handle.
A third object of the present invention is to simultaneously or alternately perform the tip deflection operation of a long medical instrument such as a catheter and the tip deflection operation of a tube introduced into the body prior to the medical instrument. It is to provide a medical tube control handle that can be used.
The fourth object of the present invention is to operate the rotary operation unit by grasping the control handle with either the left or right hand, and after performing the tip deflection operation of a long medical instrument such as a catheter. Another object of the present invention is to provide a medical tube device that can perform the tip deflection operation of the tube without changing the control handle even when the tip deflection operation is being performed.
（１）本発明の医療用チューブの制御ハンドルは、先端可撓部分を有するチューブの基端部分が内部に挿入されるハンドル本体と、前記ハンドル本体に対して回転可能に設けられ、これを操作することにより前記チューブの先端可撓部分を撓ませて当該チューブの先端を偏向させる回転操作部とを備えてなり、
　前記ハンドル本体は、前記回転操作部の基端側に位置する第１グリップ部と、前記回転操作部の先端側に位置する第２グリップ部とを有していることを特徴とする。 (1) The medical tube control handle of the present invention is provided with a handle main body into which a proximal end portion of the tube having a distal end flexible portion is inserted, and is rotatable with respect to the handle main body. A rotation operation unit that deflects the distal end of the tube by bending the distal end flexible portion of the tube,
The handle main body includes a first grip portion located on a proximal end side of the rotation operation portion and a second grip portion located on a distal end side of the rotation operation portion.
　このような構成を有する本発明の制御ハンドルによれば、左右何れか一方の手でハンドル本体の第１グリップ部を把持することにより、当該一方の手の親指および人指し指で回転操作部を操作して、当該チューブの先端偏向操作を行うことができる。
　また、左右何れか他方の手でハンドル本体の第２グリップ部を把持することによれば、当該他方の手の親指および人指し指で回転操作部を操作して、当該チューブの先端偏向操作を行うことができる。
　すなわち、この制御ハンドルによれば、左右何れの手でハンドル本体を把持する場合であっても、把持するグリップを選択することにより、回転操作部を操作してチューブの先端偏向操作を行うことができる。 According to the control handle of the present invention having such a configuration, the rotary operation unit is operated with the thumb and index finger of one hand by grasping the first grip part of the handle body with either one of the left and right hands. Thus, the tip deflection operation of the tube can be performed.
In addition, by gripping the second grip portion of the handle body with either the left or right hand, the rotation operation portion is operated with the thumb and index finger of the other hand to perform the tip deflection operation of the tube. Can do.
That is, according to this control handle, even when the handle main body is gripped by either the left or right hand, the tip of the tube can be deflected by operating the rotary operation unit by selecting the grip to be gripped. it can.
（２）本発明の医療用チューブの制御ハンドルにおいては、先端可撓部分を有するシースチューブの基端部分が内部に挿入されるハンドル本体と、前記ハンドル本体に対して回転可能に設けられ、これを操作することによって前記シースチューブの先端可撓部分を撓ませて当該シースチューブの先端を偏向させる回転操作部と、前記ハンドル本体の基端に設けられ、当該ハンドル本体の内部において前記シースチューブの基端が連結される止血弁とを備えてなることが好ましい。 (2) In the control handle for the medical tube of the present invention, the proximal end portion of the sheath tube having the distal end flexible portion is provided therein, and is provided rotatably with respect to the handle body. Is provided at the proximal end of the handle body, and is provided at the proximal end of the handle body. It is preferable to comprise a hemostasis valve to which the proximal end is connected.
　このような構成を有する本発明の制御ハンドルによれば、カテーテルなどの長尺の医療器具の制御ハンドルのハンドル本体（グリップ部）を一方の手で把持し、その先端側に位置する回転操作部を当該一方の手の親指および人指し指で操作（医療器具の先端偏向操作）しているときに、本発明の制御ハンドルのハンドル本体（第２グリップ部）を他方の手で把持することにより、その基端側に位置する回転操作部を当該他方の手の親指および人指し指で操作（シースチューブの先端偏向操作）することができる。 According to the control handle of the present invention having such a configuration, the handle body (grip part) of the control handle of a long medical instrument such as a catheter is gripped with one hand, and the rotary operation part located on the distal end side thereof When the handle body (second grip portion) of the control handle of the present invention is gripped with the other hand when the thumb is operated with the thumb and index finger of the one hand (the tip deflection operation of the medical device), The rotation operation part located on the proximal end side can be operated (the distal end deflection operation of the sheath tube) with the thumb and index finger of the other hand.
（３）本発明の医療用チューブの制御ハンドルにおいては、前記第１グリップおよび前記第２グリップが互いに同様の形状を有していることが好ましい。
　ここに「互いに同様の形状」とは、両者の形状（寸法）が完全に同一であるほか、両者の形状がほぼ同一である場合も含まれる。
　例えば、第１グリップが円柱状であるときに第２グリップも円柱状である場合、または第１グリップが矩形（角柱状）であるときに第２グリップも矩形（角柱状）である場合に、両者の長さが多少異なっていても、両者は互いに同様の形状を有するものである。
　このような構成を有する本発明の制御ハンドルによれば、第１グリップおよび第２グリップの何れを把持したときも同様の操作感を得ることができる。 (3) In the control handle for the medical tube of the present invention, it is preferable that the first grip and the second grip have the same shape.
Here, “the same shape as each other” includes the case where both shapes (dimensions) are completely the same and the shapes are almost the same.
For example, when the first grip is cylindrical and the second grip is also cylindrical, or when the first grip is rectangular (prism) and the second grip is rectangular (prism), Even if the lengths of the two are slightly different, the two have the same shape.
According to the control handle of the present invention having such a configuration, the same operational feeling can be obtained when either the first grip or the second grip is gripped.
（４）本発明の医療用チューブの制御ハンドルにおいては、前記第１グリップおよび前記第２グリップは前記回転操作部の位置する中央に向かって縮径していることが好ましい。
　このような構成を有する本発明の制御ハンドルによれば、第１グリップおよび第２グリップの何れを把持したときも、当該グリップを握りやすく、回転操作部をスムーズに操作することができる。 (4) In the control handle for a medical tube of the present invention, it is preferable that the first grip and the second grip have a diameter reduced toward a center where the rotation operation unit is located.
According to the control handle of the present invention having such a configuration, when the first grip or the second grip is gripped, the grip can be easily gripped, and the rotation operation unit can be operated smoothly.
（５）本発明の医療用チューブの制御ハンドルにおいて、前記回転操作部は、前記ハンドル本体の長手方向に直交する軸の周りを回転可能であることが好ましい。 (5) In the control handle for a medical tube of the present invention, it is preferable that the rotation operation unit is rotatable around an axis orthogonal to the longitudinal direction of the handle body.
（６）本発明の医療用チューブの制御ハンドルにおいて、前記回転操作部は、前記ハンドル本体の長手方向の軸の周りを回転可能であってもよい。 (6) In the control handle for the medical tube of the present invention, the rotation operation unit may be rotatable around a longitudinal axis of the handle body.
（７）本発明の医療用チューブ装置は、上記（１）～（６）の何れかの制御ハンドルと、
　先端可撓部分を有し、前記制御ハンドルのハンドル本体の内部に基端部分が挿入されたチューブとを備えてなることを特徴とする。 (7) A medical tube device according to the present invention includes the control handle according to any one of (1) to (6) above,
And a tube having a distal end flexible portion and having a proximal end portion inserted into the inside of the handle main body of the control handle.
　本発明の制御ハンドルによれば、左右何れの手で制御ハンドル（ハンドル本体）を把持しても、回転操作部の操作（チューブの先端偏向操作）を行うことができる。
　また、カテーテルなどの長尺の医療器具の先端偏向操作を行った後であっても、この医療器具に先行して体内に導入させたチューブの先端偏向操作を、当該チューブの制御ハンドルを持ち替えることなく実施することができる。
　さらに、カテーテルなどの長尺の医療器具の先端偏向操作と、この医療器具に先行して体内に導入させたチューブの先端偏向操作とを同時または交互に実施すことができる。 According to the control handle of the present invention, even if the control handle (handle body) is grasped with either the left or right hand, the rotation operation section (tube tip deflection operation) can be performed.
Even after the tip deflection operation of a long medical instrument such as a catheter is performed, the tip deflection operation of the tube introduced into the body prior to the medical instrument is changed by changing the control handle of the tube. Can be implemented without.
Furthermore, the tip deflection operation of a long medical instrument such as a catheter and the tip deflection operation of a tube introduced into the body prior to the medical instrument can be performed simultaneously or alternately.
　本発明の医療用チューブ装置によれば、左右何れの手で制御ハンドルを把持することによっても、回転操作部の操作を行うことができ、カテーテルなどの長尺の医療器具の先端偏向操作を行った後、または行っているときであっても、制御ハンドルを持ち替えることなくチューブの先端偏向操作を実施することができる。 According to the medical tube device of the present invention, the rotation operation unit can be operated by holding the control handle with either the left or right hand, and the tip deflection operation of a long medical instrument such as a catheter can be performed. After or after the operation, the tube tip deflection operation can be performed without changing the control handle.
本発明の一実施形態に係る制御ハンドルを備えた医療用チューブ装置（シース装置）を示す平面図である。It is a top view which shows the medical tube apparatus (sheath apparatus) provided with the control handle which concerns on one Embodiment of this invention. 図１に示したシース装置を構成する制御ハンドル（本発明の一実施形態に係る制御ハンドル）を示す斜視図である。It is a perspective view which shows the control handle (control handle which concerns on one Embodiment of this invention) which comprises the sheath apparatus shown in FIG. 図１で示したシース装置を構成するシースチューブの内孔にカテーテルシャフトが挿通されている状態を示す平面図である。It is a top view which shows the state by which the catheter shaft is penetrated by the inner hole of the sheath tube which comprises the sheath apparatus shown in FIG. 図１で示したシース装置を構成する制御ハンドル（本発明の一実施形態に係る制御ハンドル）の回転操作部およびカテーテルシャフトの制御ハンドルの回転操作部を操作している状態を示す平面図である。It is a top view which shows the state which is operating the rotation operation part of the control handle (control handle which concerns on one Embodiment of this invention) which comprises the sheath apparatus shown in FIG. 1, and the rotation operation part of the control handle of a catheter shaft. . 本発明の他の実施形態に係る制御ハンドルを示す斜視図である。It is a perspective view which shows the control handle which concerns on other embodiment of this invention. 従来公知のシース装置を示す平面図である。It is a top view which shows a conventionally well-known sheath apparatus. 図６で示したシース装置を構成するシースチューブの内孔にカテーテルシャフトが挿通されている状態を示す平面図である。It is a top view which shows the state by which the catheter shaft is penetrated by the inner hole of the sheath tube which comprises the sheath apparatus shown in FIG. 図７で示した状態において、カテーテルシャフトの制御ハンドルの回転操作部を操作している状態を示す平面図である。FIG. 8 is a plan view showing a state in which the rotation operation portion of the control handle of the catheter shaft is operated in the state shown in FIG. 7.
　以下、本発明について図面を用いて詳細に説明する。
＜第１実施形態＞
　図１～図４に示す医療用チューブ装置（シース装置）１００は、カテーテルシャフト８０を患者の体内に挿入する際に、これに先行してシースチューブ１０を体内に導入するための装置である。このシース装置１００は、シースチューブ１０と、制御ハンドル２０と、枝管（サイドアーム）３１と、三方活栓３２とを備えている。 Hereinafter, the present invention will be described in detail with reference to the drawings.
<First Embodiment>
A medical tube device (sheath device) 100 shown in FIGS. 1 to 4 is a device for introducing the sheath tube 10 into the body prior to the insertion of the catheter shaft 80 into the body of the patient. The sheath device 100 includes a sheath tube 10, a control handle 20, a branch pipe (side arm) 31, and a three-way cock 32.
　シース装置１００を構成する制御ハンドル２０（本発明の制御ハンドル）は、先端可撓部分１０Ａを有するシースチューブ１０の基端部分が内部に挿入されるハンドル本体２１と、このハンドル本体２１に対して回転可能に設けられ、これを操作することにより先端可撓部分１０Ａを撓ませてシースチューブ１０の先端を偏向させる回転板２２（回転操作部）と、ハンドル本体２１の基端側に設けられ、ハンドル本体２１の内部においてシースチューブ１０の基端が連結される止血弁２３とを備えてなり、ハンドル本体２１は、回転板２２の基端側に位置する第１グリップ部２１１と、回転板２２の先端側に位置する第２グリップ部２１２とを有している。 A control handle 20 (control handle of the present invention) constituting the sheath device 100 includes a handle body 21 into which a proximal end portion of the sheath tube 10 having a distal end flexible portion 10A is inserted, and the handle body 21. A rotation plate 22 (rotation operation part) that deflects the distal end flexible portion 10A and deflects the distal end of the sheath tube 10 by operating this, and is provided on the proximal end side of the handle body 21; The handle main body 21 includes a hemostasis valve 23 to which the proximal end of the sheath tube 10 is connected. The handle main body 21 includes a first grip portion 211 positioned on the proximal end side of the rotating plate 22 and the rotating plate 22. 2nd grip part 212 located in the front end side.
　シース装置１００を構成するシースチューブ１０の先端領域は先端可撓部分１０Ａとなっている。ここに、「先端可撓部分」とは、回転操作部を操作することにより撓む（曲がる）ことのできるチューブの先端部分をいう。 The tip region of the sheath tube 10 constituting the sheath device 100 is a tip flexible portion 10A. Here, the “tip flexible portion” refers to the tip portion of the tube that can be bent (bent) by operating the rotation operation portion.
　シースチューブ１０は、例えばポリオレフィン、ポリアミド、ポリエーテルポリアミド、ポリウレタンなどの合成樹脂からなる中空のチューブ部材によって構成されている。
　シースチューブ１０の外径は、通常２．０～５．０ｍｍとされ、好ましくは２．６～４．３ｍｍとされる。また、シースチューブ１０の内径は、通常１．６～４．３ｍｍとされ好ましくは２．０～２．８ｍｍとされる。
　シースチューブ１０の長さは、例えば５００～８００ｍｍとされ、先端可撓部分１０Ａの長さは、例えば２０～１５０ｍｍとされる。 The sheath tube 10 is configured by a hollow tube member made of a synthetic resin such as polyolefin, polyamide, polyether polyamide, or polyurethane.
The outer diameter of the sheath tube 10 is usually 2.0 to 5.0 mm, preferably 2.6 to 4.3 mm. The inner diameter of the sheath tube 10 is usually 1.6 to 4.3 mm, preferably 2.0 to 2.8 mm.
The length of the sheath tube 10 is, for example, 500 to 800 mm, and the length of the distal end flexible portion 10A is, for example, 20 to 150 mm.
　シース装置１００を構成する制御ハンドル２０は、ハンドル本体２１と、回転板２２と、止血弁２３とを備えてなる。 The control handle 20 constituting the sheath device 100 includes a handle body 21, a rotating plate 22, and a hemostasis valve 23.
　制御ハンドル２０のハンドル本体２１の内部にはシースチューブ１０の基端部分が挿入されている。
　制御ハンドル２０の回転板２２は、ハンドル本体２１に対して、このハンドル本体２１の長手方向に直交する軸の周りを回転可能に設けられている。 The proximal end portion of the sheath tube 10 is inserted into the handle main body 21 of the control handle 20.
The rotating plate 22 of the control handle 20 is provided so as to be rotatable with respect to the handle body 21 around an axis perpendicular to the longitudinal direction of the handle body 21.
　シースチューブ１０の内部には、先端可撓部分１０Ａを第１方向（図１の矢印Ａで示す方向）に撓ませるための不図示の第１操作用ワイヤと、先端可撓部分１０Ａを第２方向（図１の矢印Ｂで示す方向）に撓ませるための不図示の第２操作用ワイヤとが延在している。
　第１操作用ワイヤおよび第２操作用ワイヤの各々の先端は、シースチューブ１０の先端部に接続固定されている。
　一方、第１操作用ワイヤおよび第２操作用ワイヤの各々の後端は、制御ハンドル２０の回転板２２に接続されることにより引張操作可能になっている。 Inside the sheath tube 10, a first operation wire (not shown) for bending the distal flexible portion 10A in the first direction (the direction indicated by arrow A in FIG. 1) and the distal flexible portion 10A are second. A second operation wire (not shown) for bending in a direction (a direction indicated by an arrow B in FIG. 1) extends.
The distal ends of the first operation wire and the second operation wire are connected and fixed to the distal end portion of the sheath tube 10.
On the other hand, the rear ends of the first operation wire and the second operation wire are connected to the rotating plate 22 of the control handle 20 so that the pulling operation can be performed.
　回転板２２を、図１に示すＡ１方向に回転させると、第１操作用ワイヤが引っ張られることにより、先端可撓部分１０Ａが第１方向（図１の矢印Ａで示す方向）に撓んでシースチューブ１０の先端が第１方向に偏向する。
　また、回転板２２を、図１に示すＢ１方向に回転させると、第２操作用ワイヤが引っ張
られることにより、先端可撓部分１０Ａが第２方向（図１の矢印Ｂで示す方向）に撓んでシースチューブ１０の先端が第２方向に偏向する。
　なお、制御ハンドル２０を、長手方向の軸の周りに回転させることにより、制御ハンドル２０に対するＡ方向およびＢ方向の向きを自由に設定することができる。 When the rotating plate 22 is rotated in the A1 direction shown in FIG. 1, the distal end flexible portion 10A is bent in the first direction (the direction indicated by the arrow A in FIG. 1) by pulling the first operation wire, and the sheath. The tip of the tube 10 is deflected in the first direction.
When the rotating plate 22 is rotated in the B1 direction shown in FIG. 1, the distal end flexible portion 10A is bent in the second direction (the direction indicated by the arrow B in FIG. 1) by pulling the second operation wire. The tip of the sheath tube 10 is deflected in the second direction.
In addition, by rotating the control handle 20 around the longitudinal axis, the directions of the A direction and the B direction with respect to the control handle 20 can be freely set.
　本実施形態では、制御ハンドル２０のハンドル本体２１が、回転板２２（回転操作部）の両側に配置された２つのグリップ部（基端側に位置する第１グリップ２１１および先端側に位置する第２グリップ２１２）により構成されている点に特徴を有する。 In the present embodiment, the handle main body 21 of the control handle 20 has two grip portions (a first grip 211 located on the proximal end side and a first grip located on the distal end side) disposed on both sides of the rotating plate 22 (rotation operation portion). 2 grip 212).
　このように回転板２２の両側にグリップを有する制御ハンドル２０によれば、左右何れか一方の手（例えば右手）でハンドル本体２１の第１グリップ部２１１を把持することにより、当該一方の手（例えば右手）の親指および人指し指で回転板２２を操作すること（シースチューブ１０の先端偏向操作を行うこと）ができる。
　また、左右何れか他方の手（例えば左手）でハンドル本体２１の第２グリップ部２１２を把持することにより、当該他方の手（例えば左手）の親指および人指し指で回転板２２を操作すること（シースチューブ１０の先端偏向操作を行うこと）ができる。
　すなわち、この制御ハンドル２０によれば、左右何れの手でハンドル本体２１を把持する場合であっても、回転板２２が親指側に位置するように把持できる方のグリップを選択することにより、このグリップを把持した手の親指および人指し指で回転板２２を操作してシースチューブ１０の先端偏向操作を行うことができる。 As described above, according to the control handle 20 having grips on both sides of the rotating plate 22, by holding the first grip portion 211 of the handle body 21 with either one of the left and right hands (for example, the right hand), the one hand ( For example, the rotating plate 22 can be operated with the thumb and index finger of the right hand (the tip deflection operation of the sheath tube 10 can be performed).
Further, by grasping the second grip 212 of the handle body 21 with either the left or right hand (for example, the left hand), the rotating plate 22 can be operated with the thumb and index finger of the other hand (for example, the left hand) (sheath) The tip 10 of the tube 10 can be deflected).
That is, according to the control handle 20, even when the handle body 21 is gripped with either the left or right hand, by selecting the grip that can be gripped so that the rotating plate 22 is positioned on the thumb side, The distal end of the sheath tube 10 can be deflected by operating the rotary plate 22 with the thumb and index finger of the hand holding the grip.
　ハンドル本体２１を構成する第１グリップ２１１および第２グリップ２１２は、互いに同様の形状を有している。
　これにより、何れのグリップを把持して回転板２２を操作する場合においても、同様の操作感を得ることができる。
　また、第１グリップ２１１および第２グリップ２１２は、何れも回転板２２の位置する中央に向かって縮径している。これにより、何れのグリップを把持して回転板２２を操作する場合においても、グリップが握りやすく、回転板２２をスムーズに操作することができる。 The first grip 211 and the second grip 212 constituting the handle body 21 have the same shape.
Thereby, even when any grip is gripped and the rotary plate 22 is operated, the same operational feeling can be obtained.
Further, both the first grip 211 and the second grip 212 are reduced in diameter toward the center where the rotary plate 22 is located. Thereby, when gripping any grip and operating the rotating plate 22, the grip is easy to grip and the rotating plate 22 can be operated smoothly.
　ハンドル本体２１（第１グリップ部２１１）の基端に設けられた止血弁２３は液密性を有し、ハンドル本体２１の内部において、その基端が止血弁２３に連結しているシースチューブ１０の内孔に存在する液体（血液や枝管３１から供給される薬液など）が制御ハンドル２０の基端から外部に漏出することを防止することができる。
　この止血弁２３は、例えば、両面を貫通するスリットが形成されたエラストマーシートからなる。 The hemostasis valve 23 provided at the proximal end of the handle body 21 (first grip portion 211) has liquid tightness, and the sheath tube 10 whose proximal end is connected to the hemostasis valve 23 inside the handle body 21. It is possible to prevent liquid (such as blood or a chemical solution supplied from the branch pipe 31) existing in the inner hole from leaking out from the base end of the control handle 20.
The hemostasis valve 23 is made of, for example, an elastomer sheet in which slits penetrating both surfaces are formed.
　シース装置１００を構成する枝管３１の内孔は、シースチューブ１０の内孔と連通しており、枝管３１から供給される薬液などは、シースチューブ１０の内孔を通って体内に供給することができる。 The inner hole of the branch pipe 31 constituting the sheath device 100 communicates with the inner hole of the sheath tube 10, and the chemical solution or the like supplied from the branch pipe 31 is supplied into the body through the inner hole of the sheath tube 10. be able to.
　本実施形態のシース装置１００により、これを構成するシースチューブ１０を患者の体内に導入することができる。
　シースチューブ１０の導入方法としては、シースチューブ１０の内孔にダイレータ（図示せず）を挿入し、ダイレータと一体化させたシースチューブ１０を患者の血管内に挿入し、制御ハンドル２０の回転板２２によって先端偏向操作を行いながら、予め挿入されているガイドワイヤに沿ってシースチューブ１０を目的部位（患部）に向けて移動させる。シースチューブ１０の先端開口が目的部位（患部）の近傍に到達したところで、ダイレータおよびガイドワイヤを抜去する。これにより、シースチューブ６０の先端部分が患者の体内に留置される。 With the sheath device 100 of the present embodiment, the sheath tube 10 constituting the sheath device 100 can be introduced into the patient's body.
As a method for introducing the sheath tube 10, a dilator (not shown) is inserted into the inner hole of the sheath tube 10, the sheath tube 10 integrated with the dilator is inserted into the blood vessel of the patient, and the rotating plate of the control handle 20 is inserted. The sheath tube 10 is moved toward the target site (affected site) along the guide wire that is inserted in advance while performing the tip deflection operation. When the distal end opening of the sheath tube 10 reaches the vicinity of the target site (affected site), the dilator and the guide wire are removed. Thereby, the front-end | tip part of the sheath tube 60 is detained in a patient's body.
　このようにして体内に導入されたシースチューブ１０を利用してカテーテルシャフトを体内に挿入することができる。
　カテーテルシャフトの挿入方法としては、図３に示すように、カテーテルシャフト８０の先端を制御ハンドル２０の基端（止血弁２３）からシースチューブ１０の内孔に挿入し、制御ハンドル９０の回転板９２によって先端偏向操作を行いながら、シースチューブ１０の内孔に沿ってカテーテルシャフト８０を移動させ、シースチューブ１０の先端開口からカテーテルシャフト８０の先端可撓部分８０Ａを延び出させる。 The catheter shaft can be inserted into the body using the sheath tube 10 thus introduced into the body.
As a method for inserting the catheter shaft, as shown in FIG. 3, the distal end of the catheter shaft 80 is inserted into the inner hole of the sheath tube 10 from the proximal end (the hemostatic valve 23) of the control handle 20, and the rotating plate 92 of the control handle 90 is inserted. While performing the tip deflection operation, the catheter shaft 80 is moved along the inner hole of the sheath tube 10, and the tip flexible portion 80A of the catheter shaft 80 is extended from the tip opening of the sheath tube 10.
　次に、制御ハンドル９０の回転板９２を操作して先端可撓部分８０Ａを撓ませることによりカテーテルシャフト８０の先端を偏向させるとともに、必要に応じて、制御ハンドル２０の回転板２２を操作して先端可撓部分１０Ａを撓ませることによってシースチューブ１０の先端を偏向させる。これにより、カテーテルシャフト８０の先端部（例えば、電極カテーテルにおける電極）の位置が調整され、これを目的部位（患部）に到達させることができる。 Next, the distal end of the catheter shaft 80 is deflected by operating the rotating plate 92 of the control handle 90 to bend the distal end flexible portion 80A, and the rotating plate 22 of the control handle 20 is operated as necessary. The distal end of the sheath tube 10 is deflected by bending the distal flexible portion 10A. Thereby, the position of the distal end portion of the catheter shaft 80 (for example, an electrode in the electrode catheter) is adjusted, and this can reach the target site (affected site).
　図４に示すように、カテーテルシャフト８０の先端を偏向させるための回転板９２の操作は、制御ハンドル９０のハンドル本体９１を把持する右手の親指および人指し指によって行われ、シースチューブ１０の先端を偏向させるための回転板２２の操作は、制御ハンドル２０の第２グリップ２１２を把持する左手の親指および人指し指により行われる。
　これにより、カテーテルシャフト８０の先端偏向操作を実施した後であっても、制御ハンドル２０を右手に持ち替えることなく、シースチューブ１０の先端偏向操作を実施することができ、カテーテルシャフト８０の先端偏向操作と、シースチューブ１０の先端偏向操作とを、同時または交互に実施すことができる。 As shown in FIG. 4, the operation of the rotating plate 92 for deflecting the distal end of the catheter shaft 80 is performed by the right thumb and index finger holding the handle body 91 of the control handle 90 to deflect the distal end of the sheath tube 10. The operation of the rotary plate 22 is performed by the left thumb and index finger holding the second grip 212 of the control handle 20.
Thereby, even after the distal end deflection operation of the catheter shaft 80 is performed, the distal end deflection operation of the sheath tube 10 can be performed without changing the control handle 20 to the right hand. And the tip deflection operation of the sheath tube 10 can be performed simultaneously or alternately.
　上記のようにしてカテーテルシャフト８０の先端部が位置決めされた後、カテーテルによる手技（診断・治療）が行われる。
　カテーテルによる手技の終了後、カテーテルシャフト８０が体内から抜去され、次いで、シースチューブ１０が体内から抜去される。 After the distal end portion of the catheter shaft 80 is positioned as described above, a catheter procedure (diagnosis / treatment) is performed.
After completion of the catheter procedure, the catheter shaft 80 is removed from the body, and then the sheath tube 10 is removed from the body.
＜第２実施形態＞
　図５は、本発明の他の実施形態に係る制御ハンドルを示す。
　この制御ハンドル２５は、シースチューブ１０の基端部分が内部に挿入されるハンドル本体２６と、このハンドル本体２６に対して回転可能に設けられ、これを操作することによってシースチューブ１０の先端可撓部分を撓ませてシースチューブ１０の先端を偏向させる回転操作部２７と、ハンドル本体２６の基端に設けられ止血弁２３とを備えてなる。同図において、第１実施形態と同様の構成要素については同一の符号を付している。 <Second Embodiment>
FIG. 5 shows a control handle according to another embodiment of the present invention.
The control handle 25 is provided with a handle main body 26 into which the proximal end portion of the sheath tube 10 is inserted, and is rotatable with respect to the handle main body 26. The rotary operation part 27 which deflects a part and deflects the front-end | tip of the sheath tube 10 and the hemostatic valve 23 provided in the base end of the handle body 26 are provided. In the figure, the same components as those in the first embodiment are denoted by the same reference numerals.
　制御ハンドル２５を構成する回転操作部２７は、ハンドル本体２６の長手方向の軸の周りを回転可能に設けられている。
　回転操作部２７を、図５に示すａ１方向に回転させると、シースチューブ１０の先端可撓部分が第１方向に撓んで、シースチューブ１０の先端が第１方向に偏向する。
　また、回転操作部２７を、図５に示すｂ１方向に回転させると、シースチューブ１０の先端可撓部分が第１方向とは反対の第２方向に撓んで、シースチューブ１０の先端が第２方向に偏向する。 The rotation operation unit 27 constituting the control handle 25 is provided so as to be rotatable around the longitudinal axis of the handle body 26.
When the rotation operation unit 27 is rotated in the a1 direction shown in FIG. 5, the distal flexible portion of the sheath tube 10 is bent in the first direction, and the distal end of the sheath tube 10 is deflected in the first direction.
When the rotation operation unit 27 is rotated in the b1 direction shown in FIG. 5, the distal end flexible portion of the sheath tube 10 is bent in the second direction opposite to the first direction, and the distal end of the sheath tube 10 is the second. Deflect in the direction.
　制御ハンドル２５を構成するハンドル本体２６は、回転操作部２７の基端側に位置する第１グリップ部２６１と、回転操作部２７の先端側に位置する第２グリップ部２６２とを有している。 The handle main body 26 constituting the control handle 25 has a first grip part 261 located on the proximal end side of the rotation operation part 27 and a second grip part 262 located on the distal end side of the rotation operation part 27. .
　このように回転操作部２７の両側にグリップを有する制御ハンドル２５によれば、左右何れか一方の手（例えば右手）でハンドル本体２６の第１グリップ部２６１を把持することにより、当該一方の手（例えば右手）の親指および人指し指で回転操作部２７を操作する（シースチューブ１０の先端偏向操作を行う）ことができる。 As described above, according to the control handle 25 having grips on both sides of the rotation operation unit 27, the first grip portion 261 of the handle body 26 is held by either one of the left and right hands (for example, the right hand), thereby The rotation operation unit 27 can be operated with the thumb (for example, the right hand) and the index finger (the tip deflection operation of the sheath tube 10 is performed).
　また、左右何れか他方の手（例えば左手）でハンドル本体２６の第２グリップ部２６２を把持することにより、当該他方の手（例えば左手）の親指および人指し指で回転操作部２７を操作する（シースチューブ１０の先端偏向操作を行う）ことができる。
　この結果、左右何れの手でハンドル本体２６を把持することによっても、回転操作部２７が親指側に位置するように把持できる方のグリップを選択することにより、このグリップを把持した手の親指および人指し指で回転操作部２７を操作してシースチューブ１０の先端偏向操作を行うことができる。 In addition, by holding the second grip 262 of the handle body 26 with either the left or right hand (for example, the left hand), the rotation operation unit 27 is operated with the thumb and index finger of the other hand (for example, the left hand) (sheath) The tip of the tube 10 can be deflected).
As a result, by selecting the grip that can be gripped so that the rotation operation unit 27 is positioned on the thumb side by gripping the handle body 26 with either the left or right hand, the thumb of the hand gripping this grip and The distal end deflection operation of the sheath tube 10 can be performed by operating the rotation operation unit 27 with the index finger.
　以上、本発明の実施形態について説明したが、本発明はこれらに限定されるものではなく、種々の偏向が可能である。
　また、本発明の制御ハンドルが装着されるチューブは、シースチューブに限定されず、診断・治療などに直接使用されるカテーテルシャフトであってもよい。 Although the embodiments of the present invention have been described above, the present invention is not limited to these embodiments, and various deflections are possible.
The tube to which the control handle of the present invention is attached is not limited to a sheath tube, and may be a catheter shaft that is directly used for diagnosis and treatment.
　１００　シース装置
　１０　シースチューブ
　１０Ａ　先端可撓部分
　２１　ハンドル本体
　２２　回転板（回転操作部）
　２３　止血弁
　２１１　第１グリップ部
　２１２　第２グリップ部
　２５　制御ハンドル
　２６　ハンドル本体
　２７　回転操作部
　２６１　第１グリップ部
　２６２　第２グリップ部
　３１　枝管（サイドアーム）
　３２　三方活栓
　８０　カテーテルシャフト
　８０Ａ　先端可撓部分
　９０　制御ハンドル
　９１　ハンドル本体
　９２　回転板（回転操作部） DESCRIPTION OF SYMBOLS 100 Sheath apparatus 10 Sheath tube 10A Tip flexible part 21 Handle body 22 Rotating plate (Rotation operation part)
23 hemostatic valve 211 first grip portion 212 second grip portion 25 control handle 26 handle body 27 rotation operation portion 261 first grip portion 262 second grip portion 31 branch pipe (side arm)
32 Three-way stopcock 80 Catheter shaft 80A Flexible tip 90 Control handle 91 Handle body 92 Rotating plate (Rotating operation part)

Claims (7)

  1. 　先端可撓部分を有するチューブの基端部分が内部に挿入されるハンドル本体と、前記ハンドル本体に対して回転可能に設けられ、これを操作することにより前記チューブの先端可撓部分を撓ませて当該チューブの先端を偏向させる回転操作部とを備えてなり、
    　前記ハンドル本体は、前記回転操作部の基端側に位置する第１グリップ部と、前記回転操作部の先端側に位置する第２グリップ部とを有していることを特徴とする医療用チューブの制御ハンドル。     A proximal end portion of a tube having a distal end flexible portion is provided therein, and is provided rotatably with respect to the handle body. By operating this, the distal end flexible portion of the tube is bent. A rotation operation unit that deflects the tip of the tube,
    The handle main body includes a first grip portion located on a proximal end side of the rotation operation portion and a second grip portion located on a distal end side of the rotation operation portion. Control handle.
  2. 　先端可撓部分を有するシースチューブの基端部分が内部に挿入されるハンドル本体と、前記ハンドル本体に対して回転可能に設けられ、これを操作することによって前記シースチューブの先端可撓部分を撓ませて当該シースチューブの先端を偏向させる回転操作部と、前記ハンドル本体の基端に設けられ、当該ハンドル本体の内部において前記シースチューブの基端が連結される止血弁とを備えてなることを特徴とする請求項１に記載の医療用チューブの制御ハンドル。 A proximal end portion of a sheath tube having a distal end flexible portion is provided inside the handle body and is rotatably provided with respect to the handle body. By operating this, the distal end flexible portion of the sheath tube is bent. A rotation operation unit for deflecting the distal end of the sheath tube; and a hemostasis valve provided at the proximal end of the handle body and connected to the proximal end of the sheath tube inside the handle body. The medical tube control handle according to claim 1, wherein:
  3. 　前記第１グリップおよび前記第２グリップが互いに同様の形状を有していることを特徴とする請求項１または請求項２に記載の制御ハンドル。 The control handle according to claim 1 or 2, wherein the first grip and the second grip have the same shape.
  4. 　前記第１グリップおよび前記第２グリップは前記回転操作部の位置する中央に向かって縮径していることを特徴とする請求項１乃至請求項３の何れかに記載の制御ハンドル。 The control handle according to any one of claims 1 to 3, wherein the first grip and the second grip are reduced in diameter toward a center where the rotation operation unit is located.
  5. 　前記回転操作部は、前記ハンドル本体の長手方向に直交する軸の周りを回転可能であることを特徴とする請求項１乃至請求項４の何れかに記載の制御ハンドル。 The control handle according to any one of claims 1 to 4, wherein the rotation operation unit is rotatable around an axis orthogonal to a longitudinal direction of the handle body.
  6. 　前記回転操作部は、前記ハンドル本体の長手方向の軸の周りを回転可能であることを特徴とする請求項１乃至請求項４の何れかに記載の制御ハンドル。 The control handle according to any one of claims 1 to 4, wherein the rotation operation unit is rotatable around a longitudinal axis of the handle body.
  7. 　請求項１乃至請求項６の何れかに記載の制御ハンドルと、
    　先端可撓部分を有し、前記制御ハンドルのハンドル本体の内部に基端部分が挿入されたチューブとを備えてなることを特徴とする医療用チューブ装置。     A control handle according to any one of claims 1 to 6;
    A medical tube device comprising a tube having a distal end flexible portion and having a proximal end portion inserted into an inside of a handle main body of the control handle.
PCT/JP2013/055947 2012-03-19 2013-03-05 Medical tube control handle and medical tube device WO2013141011A1 (en)

Applications Claiming Priority (2)

Application Number Priority Date Filing Date Title
JP2012-061947 2012-03-19
JP2012061947A JP2013192691A (en) 2012-03-19 2012-03-19 Medical tube control handle and medical tube introducing device

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WO2013141011A1 true WO2013141011A1 (en) 2013-09-26

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US11147635B1 (en) 2020-06-19 2021-10-19 Remedy Robotics, Inc. Systems and methods for guidance of intraluminal devices within the vasculature
US11690683B2 (en) 2021-07-01 2023-07-04 Remedy Robotics, Inc Vision-based position and orientation determination for endovascular tools
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Publication number Priority date Publication date Assignee Title
US11147635B1 (en) 2020-06-19 2021-10-19 Remedy Robotics, Inc. Systems and methods for guidance of intraluminal devices within the vasculature
US11154366B1 (en) 2020-06-19 2021-10-26 Remedy Robotics, Inc. Systems and methods for guidance of intraluminal devices within the vasculature
US11197725B1 (en) 2020-06-19 2021-12-14 Remedy Robotics, Inc. Systems and methods for guidance of intraluminal devices within the vasculature
US11229488B2 (en) 2020-06-19 2022-01-25 Remedy Robotics, Inc. Systems and methods for guidance of intraluminal devices within the vasculature
US11246667B2 (en) 2020-06-19 2022-02-15 Remedy Robotics, Inc. Systems and methods for guidance of intraluminal devices within the vasculature
US11779406B2 (en) 2020-06-19 2023-10-10 Remedy Robotics, Inc. Systems and methods for guidance of intraluminal devices within the vasculature
US11690683B2 (en) 2021-07-01 2023-07-04 Remedy Robotics, Inc Vision-based position and orientation determination for endovascular tools
US11707332B2 (en) 2021-07-01 2023-07-25 Remedy Robotics, Inc. Image space control for endovascular tools

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JP2013192691A (en) 2013-09-30

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