JP7465882B2 - Atherectomy device for intravascular calcified lesions - Google Patents

Atherectomy device for intravascular calcified lesions Download PDF

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JP7465882B2
JP7465882B2 JP2021546844A JP2021546844A JP7465882B2 JP 7465882 B2 JP7465882 B2 JP 7465882B2 JP 2021546844 A JP2021546844 A JP 2021546844A JP 2021546844 A JP2021546844 A JP 2021546844A JP 7465882 B2 JP7465882 B2 JP 7465882B2
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atherectomy
head
cone
water turbine
spiral tube
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JP2022525503A (en
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永▲チ▼ 張
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為泰医療器械(深▲セン▼)有限公司
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    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61BDIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00Surgical instruments, devices or methods, e.g. tourniquets
    • A61B17/32Surgical cutting instruments
    • A61B17/3205Excision instruments
    • A61B17/3207Atherectomy devices working by cutting or abrading; Similar devices specially adapted for non-vascular obstructions
    • A61B17/320758Atherectomy devices working by cutting or abrading; Similar devices specially adapted for non-vascular obstructions with a rotating cutting instrument, e.g. motor driven
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61BDIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00Surgical instruments, devices or methods, e.g. tourniquets
    • A61B17/22Implements for squeezing-off ulcers or the like on the inside of inner organs of the body; Implements for scraping-out cavities of body organs, e.g. bones; Calculus removers; Calculus smashing apparatus; Apparatus for removing obstructions in blood vessels, not otherwise provided for
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61BDIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00Surgical instruments, devices or methods, e.g. tourniquets
    • A61B2017/00535Surgical instruments, devices or methods, e.g. tourniquets pneumatically or hydraulically operated
    • A61B2017/00539Surgical instruments, devices or methods, e.g. tourniquets pneumatically or hydraulically operated hydraulically
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61BDIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00Surgical instruments, devices or methods, e.g. tourniquets
    • A61B2017/00535Surgical instruments, devices or methods, e.g. tourniquets pneumatically or hydraulically operated
    • A61B2017/00553Surgical instruments, devices or methods, e.g. tourniquets pneumatically or hydraulically operated using a turbine
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61BDIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00Surgical instruments, devices or methods, e.g. tourniquets
    • A61B17/32Surgical cutting instruments
    • A61B2017/320004Surgical cutting instruments abrasive
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61BDIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00Surgical instruments, devices or methods, e.g. tourniquets
    • A61B17/32Surgical cutting instruments
    • A61B17/3205Excision instruments
    • A61B17/3207Atherectomy devices working by cutting or abrading; Similar devices specially adapted for non-vascular obstructions
    • A61B2017/320741Atherectomy devices working by cutting or abrading; Similar devices specially adapted for non-vascular obstructions for stripping the intima or the internal plaque from a blood vessel, e.g. for endarterectomy
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61BDIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00Surgical instruments, devices or methods, e.g. tourniquets
    • A61B17/32Surgical cutting instruments
    • A61B17/3205Excision instruments
    • A61B17/3207Atherectomy devices working by cutting or abrading; Similar devices specially adapted for non-vascular obstructions
    • A61B17/320758Atherectomy devices working by cutting or abrading; Similar devices specially adapted for non-vascular obstructions with a rotating cutting instrument, e.g. motor driven
    • A61B2017/320766Atherectomy devices working by cutting or abrading; Similar devices specially adapted for non-vascular obstructions with a rotating cutting instrument, e.g. motor driven eccentric

Description

本発明は、医療機器に関し、特に、冠動脈石灰化病変への治療介入の機器に関する。 The present invention relates to medical devices, and in particular to devices for therapeutic intervention in coronary artery calcification lesions.

回転式アテレクトミー(Rotational atherectomy)は、例えば高度石灰化病変などの一部の特殊な病変に対する経皮的冠動脈インターベンションPCIをスムーズに完了させるために不可欠な手術である。高度狭窄、高度石灰化又は線維化の一部病変にとって、臨床的に有益な介入治療手段である。従来技術では、アテレクトミーデバイスを用い、人体の冠動脈内に介入する高速回転ダイヤモンドドリルで、動脈内の病変を削って高度閉塞している冠動脈を開通させる。1つは、高速モータの駆動を利用してダイヤモンドドリルを回転させものがあり、代表的な製品がCSI Diamondback 360 Coronary Orbital Atherectomy Systemである。もう1つは、高圧ガスの動力伝達を利用してガスの運動エネルギーをダイヤモンドドリル回転の機械的エネルギーに変換するもので、代表的な製品がボストン・サイエンティフィック社製Rotablatorである。 Rotational atherectomy is an essential procedure for smoothly completing percutaneous coronary intervention (PCI) for some special lesions, such as those with severe calcification. It is a clinically useful interventional treatment for some lesions with severe stenosis, severe calcification, or fibrosis. In the prior art, an atherectomy device is used to drill a lesion in the coronary artery of the human body using a high-speed rotating diamond drill to open a severely blocked coronary artery. One type uses the drive of a high-speed motor to rotate the diamond drill, and a representative product is the CSI Diamondback 360 Coronary Orbital Atherectomy System. The other type uses the power transmission of high-pressure gas to convert the kinetic energy of the gas into the mechanical energy of the diamond drill rotation, and a representative product is the Rotabulator manufactured by Boston Scientific.

上記の2つのアテレクトミーデバイスは、同時に次の欠点がある。
1.人体内でダイヤモンドドリルとドリルキャリアの高速回転は、大量の熱を発生し、血管痙攣、急性血栓症、急性心筋梗塞などの一連の合併症を患者に生じる可能性があり;
2.使用過程で、大量の潤滑冷却液を人体の動脈内に投与し、人体の腎臓に大きな負担をかけ;
3.使用過程で、駆動モータ及び高圧ガスが大きな騒音を発生し;
4.アテレクトミーヘッドが病変のアテレクトミー施行く過程で発生したアテレクトミー後の残余粒子が血液と潤滑剤によって洗い流して血管病変の遠位端に流れ込む。
The above two atherectomy devices simultaneously have the following disadvantages.
1. The high-speed rotation of the diamond drill and drill carrier inside the human body will generate a large amount of heat, which may cause a series of complications in the patient, such as vasospasm, acute thrombosis, and acute myocardial infarction;
2. During use, a large amount of lubricant coolant is injected into the human arteries, which puts a heavy burden on the human kidneys;
3. During use, the driving motor and high pressure gas generate loud noises;
4. Post-atherectomy particles generated during the atherectomy head atherectomy of the lesion are washed away by blood and lubricant and flow into the distal end of the vascular lesion.

上記の2つのアテレクトミーデバイスは、各々次の欠点がある。
1.モータ駆動のダイヤモンドドリル構造形状が血管内の正方向狭窄の大面積閉塞(詰まり)病変のアテレクトミー施行について、効果的に血管を開通させにくく;モータを制御する多くの制御信号が必要とし、無線に干渉されやすく;モータ制御ボードにはバッテリーによる電力供給が必要で、バッテリーには、有効な蓄電容量時間のリスクが存在している。
2.高圧ガス動力伝達のダイヤモンドドリル構造形状は、血管壁の片側石灰化病変と血管分岐部石灰化病変の改善に適していなく;機器全体の体積も大きく、機器の接続も複雑である。
The above two atherectomy devices each have the following disadvantages.
1. The motor-driven diamond drill structure shape makes it difficult to effectively open blood vessels when performing atherectomy for large-area occlusion (blockage) lesions of positive stenosis in blood vessels; many control signals are required to control the motor, which is easily interfered with by radio; the motor control board needs to be powered by a battery, and there is a risk that the battery will run out of effective storage capacity.
2. The diamond drill structure shape of the high pressure gas power transmission is not suitable for improving unilateral calcification lesions of the vascular wall and calcification lesions at the vascular bifurcation; the overall volume of the device is large, and the connection of the device is complicated.

本発明の目的は、血管内石灰化病変のアテレクトミーデバイスを提供することであり、手術の安全性を向上し、コストを削減することを、その技術的課題とするものである。 The objective of the present invention is to provide an atherectomy device for intravascular calcification lesions, and its technical objectives are to improve the safety of surgery and reduce costs.

本発明は、上記課題を解決するために以下のような技術的手段を講じた。
アテレクトミーヘッドを設けた血管内石灰化病変用アテレクトミーデバイスであって、前記アテレクトミーヘッドは、ウォーターポンプを用いて水力タービンの駆動によって回転されることを特徴とする。
In order to solve the above problems, the present invention provides the following technical solutions.
An atherectomy device for intravascular calcified lesions comprising an atherectomy head, the atherectomy head being rotated by driving a water turbine using a water pump.

本発明のウォーターポンプは、定圧ウォーターポンプであり、定圧ウォーターポンプが流量制御弁、水力タービンを介してアテレクトミーヘッドに接続され、定圧ウォーターポンプの出力液圧が50Mpa以上で、アテレクトミーヘッドの回転数が70000~150000rad/minの範囲で、流量制御弁の出力液体流量を調整し、アテレクトミーヘッドの回転数を70000~150000rad/min範囲の特定の値に制御する。 The water pump of the present invention is a constant pressure water pump, which is connected to an atherectomy head via a flow control valve and a hydraulic turbine, and the output liquid flow rate of the flow control valve is adjusted when the output liquid pressure of the constant pressure water pump is 50 MPa or more and the rotation speed of the atherectomy head is in the range of 70,000 to 150,000 rad/min, thereby controlling the rotation speed of the atherectomy head to a specific value in the range of 70,000 to 150,000 rad/min.

本発明の水力タービンは、水車と動力伝達増速機構を連結することよって構成される。 The hydraulic turbine of the present invention is constructed by connecting a water wheel and a power transmission speed increasing mechanism.

本発明の水車と動力伝達増速機構とアテレクトミーヘッドとは、同軸上に連結される。 The water wheel, power transmission acceleration mechanism, and atherectomy head of the present invention are connected coaxially.

本発明の水車にシェルアセンブリが設けられ、シェルアセンブリ内に水車回転子が同軸に設けられ、シェルアセンブリの円筒の内径は、16~30mmの範囲、外径が18~34mmの範囲であり、円筒の中央部が円筒よりも直径が小さいそれぞれ流入口、流出口である別の2つの円筒と半径方向に沿って接続され、流入口、流出口の軸線が円筒の軸線に垂直で、30°~60°に分布し;前記水車回転子に中央軸が設けられ、中央軸の軸線に沿って貫通穴が設けられ、中央軸に少なくとも2つのブレードが連結される。 The water turbine of the present invention is provided with a shell assembly, and a water turbine rotor is coaxially provided within the shell assembly. The inner diameter of the cylinder of the shell assembly is in the range of 16 to 30 mm, and the outer diameter is in the range of 18 to 34 mm. The center of the cylinder is radially connected to two other cylinders, which are an inlet and an outlet, respectively, and have a smaller diameter than the cylinder. The axes of the inlet and outlet are perpendicular to the axis of the cylinder and are distributed at 30° to 60°; a central shaft is provided in the water turbine rotor, a through hole is provided along the axis of the central shaft, and at least two blades are connected to the central shaft.

本発明の動力伝達増速機構は、一次遊星増速歯車機構と二次遊星増速歯車機構とを連結することによって構成される。 The power transmission speed increasing mechanism of the present invention is constructed by connecting a primary planetary speed increasing gear mechanism and a secondary planetary speed increasing gear mechanism.

本発明のアテレクトミーヘッドに六角形の中空軸が設けられ、六角形の中空軸の一端は、二次遊星増速歯車機構の出力軸と取り外し可能な連結構造を形成し、他端がアテレクトミースパイラルチューブの一端に連結され、アテレクトミースパイラルチューブの他端にアテレクトミーヘッドが外嵌され、アテレクトミースパイラルチューブがアテレクトミーヘッドから突き出す。 The atherectomy head of the present invention is provided with a hexagonal hollow shaft, one end of which forms a removable connection structure with the output shaft of the secondary planetary speed-up gear mechanism, and the other end of which is connected to one end of the atherectomy spiral tube, the atherectomy head is fitted onto the other end of the atherectomy spiral tube, and the atherectomy spiral tube protrudes from the atherectomy head.

本発明のアテレクトミーヘッドの軸方向断面は、ひょうたん形であり、ひょうたん形の小端部が遠位端に面し、アテレクトミースパイラルチューブの軸線がアテレクトミーヘッドの軸線と重なる。 The axial cross section of the atherectomy head of the present invention is gourd-shaped, with the small end of the gourd facing the distal end, and the axis of the atherectomy spiral tube overlapping with the axis of the atherectomy head.

本発明のアテレクトミーヘッドの軸方向断面は、台形と矩形の組み合わせた後の形状であり、台形の底部が矩形の長辺と重なり、アテレクトミースパイラルチューブの軸方向断面が矩形と重なり、アテレクトミースパイラルチューブの軸方向断面の上部外縁がアテレクトミーヘッドの台形の底部と重なることで、偏心アテレクトミーヘッドを構成させる。 The axial cross section of the atherectomy head of the present invention has a shape obtained by combining a trapezoid and a rectangle, with the bottom of the trapezoid overlapping the long side of the rectangle, the axial cross section of the atherectomy spiral tube overlapping the rectangle, and the upper outer edge of the axial cross section of the atherectomy spiral tube overlapping the bottom of the trapezoid of the atherectomy head, thereby forming an eccentric atherectomy head.

本発明のアテレクトミーヘッドの軸方向断面の遠位端は、ひょうたん形の小端形状であり、アテレクトミースパイラルチューブの軸線がひょうたん形の軸線と重なり、ひょうたん形小端の大きな外径を小端部とし、軸方向に沿って近位端に向けて第1円錐形を延在し、第1円錐形の大端部が円柱状に延在し、円柱状の外径を大端部として近位端に沿って第2円錐形を延在し、第2円錐形の小端部を第3円錐形の大端部とし、近位端に沿って第3円錐形を延在し、円柱状の長さが第1円錐形の軸方向の長さよりも短く、アテレクトミーヘッドの軸方向断面の下部が軸方向に沿って切り取られ、その下部外縁が第1円錐形の小端部の外径と同じになり、第3円錐形の大端部まで、偏心アテレクトミーヘッドを構成させる。 The distal end of the axial cross section of the atherectomy head of the present invention is a gourd-shaped small end shape, the axis of the atherectomy spiral tube overlaps with the axis of the gourd shape, the larger outer diameter of the small end of the gourd shape is the small end, a first cone extends along the axial direction toward the proximal end, the large end of the first cone extends cylindrically, a second cone extends along the proximal end with the outer diameter of the cylinder as the large end, the small end of the second cone is the large end of a third cone, and the third cone extends along the proximal end, the length of the cylinder is shorter than the axial length of the first cone, the lower part of the axial cross section of the atherectomy head is cut along the axial direction, and the lower outer edge is the same as the outer diameter of the small end of the first cone, forming an eccentric atherectomy head up to the large end of the third cone.

従来技術と比較して、本発明は、高圧液体衝撃水車を用いて、液体の運動エネルギーを水車回転の機械的エネルギーに変換し、動力伝達増速機構を駆動してアテレクトミーヘッドの回転を実現し、人体の末梢動脈と冠動脈の血管内の高度狭窄、高度石灰化或いは線維性の粥状動脈硬化病変を開通又は改善するために用いられ、アテレクトミーヘッドの高速回転や動力伝達の騒音も低く、アテレクトミー施行によってもたらされる人体内に滞留する摩擦熱を低減し、人体への冷却と潤滑溶液の投与量を減らし、人体の腎臓代謝負荷を軽減し、安全で信頼的で、構造が単純で、コストも低い。 Compared with the prior art, the present invention uses a high-pressure liquid impulse turbine to convert the kinetic energy of the liquid into the mechanical energy of turbine rotation, and drives the power transmission acceleration mechanism to rotate the atherectomy head, which is used to open or improve severe stenosis, severe calcification, or fibrous atherosclerotic lesions in the peripheral and coronary arteries of the human body. The high-speed rotation of the atherectomy head and the noise of the power transmission are low, the frictional heat retained in the human body caused by atherectomy is reduced, the amount of cooling and lubricating solution administered to the human body is reduced, and the metabolic burden on the human kidney is reduced, which is safe and reliable, has a simple structure, and is low cost.

本発明の構造ブロック図である。FIG. 2 is a structural block diagram of the present invention. 本発明の水力タービン構造の分解図である。FIG. 2 is an exploded view of the water turbine structure of the present invention. 本発明の動力伝達増速機構構造の分解図である。FIG. 2 is an exploded view of the power transmission speed increasing mechanism structure of the present invention. 本発明の水車構造の分解図である。FIG. 2 is an exploded view of the water turbine structure of the present invention. 本発明の水力タービンの外形図である。FIG. 1 is an outline view of a water turbine of the present invention. 本発明の水力タービン軸方向断面図である。1 is an axial cross-sectional view of a water turbine according to the present invention; 本発明の水力タービン部材構造の分解図である。FIG. 2 is an exploded view of the water turbine component structure of the present invention. 本発明の水車の軸方向断面図である。FIG. 2 is an axial cross-sectional view of the water turbine of the present invention. 本発明の動力伝達増速機構の軸方向断面図である。FIG. 2 is an axial cross-sectional view of the power transmission speed increasing mechanism of the present invention. 本発明のアテレクトミーヘッド概略構成図である。1 is a schematic diagram of an atherectomy head according to the present invention; 本発明のアテレクトミースパイラルチューブの概略構成図である。FIG. 1 is a schematic diagram of an atherectomy spiral tube of the present invention. 本発明のアテレクトミースパイラルチューブ軸方向断面図である。FIG. 2 is an axial cross-sectional view of the atherectomy spiral tube of the present invention. 本発明のアテレクトミースパイラルチューブ断面図である。FIG. 2 is a cross-sectional view of the atherectomy spiral tube of the present invention. 本発明のアテレクトミーヘッド構造の概略図(一)である。FIG. 1 is a schematic diagram of an atherectomy head structure according to the present invention (first embodiment). 本発明のアテレクトミーヘッド構造の概略図(二)である。FIG. 2 is a schematic diagram of the atherectomy head structure of the present invention (II). 本発明のアテレクトミーヘッド構造の概略図(三)である。FIG. 3 is a schematic diagram of the atherectomy head structure of the present invention. 本発明のシェルアセンブリの流入口、流出口分布を示す概略図である。FIG. 2 is a schematic diagram showing the distribution of inlets and outlets of the shell assembly of the present invention. 図17の右側面図である。FIG. 18 is a right side view of FIG. 17 . 本発明の水車回転子の概略構成図である。FIG. 1 is a schematic diagram of a water turbine rotor according to the present invention. 図19の左側面図である。FIG. 20 is a left side view of FIG. 19 . 本発明の水車取り付け位置を示す概略図である。FIG. 2 is a schematic diagram showing the mounting position of the water turbine of the present invention. 図21の左側面図である。FIG. 22 is a left side view of FIG. 21 .

以下、図面及び実施例を参照しつつ本発明をさらに詳細に説明する。本発明の血管内石灰化病変用アテレクトミーデバイスは、高圧液体衝撃水車を用いて、運動エネルギーを水車回転の機械的エネルギーに変換し、回転している水車によって動力伝達増速機構を駆動して、アテレクトミーヘッドの回転を実現し、人体の末梢動脈と冠動脈の血管内の高度狭窄、高度石灰化或いは線維性の粥状動脈硬化病変を開通又は改善する。 The present invention will be described in more detail below with reference to the drawings and examples. The atherectomy device for intravascular calcified lesions of the present invention uses a high-pressure liquid impulse water wheel to convert kinetic energy into mechanical energy for water wheel rotation, and the rotating water wheel drives a power transmission acceleration mechanism to rotate the atherectomy head, thereby opening or improving severe stenosis, severe calcification, or fibrotic atherosclerotic lesions in the peripheral and coronary arteries of the human body.

図1に示すように、本発明の血管内石灰化病変用アテレクトミーデバイスは、近位端から遠位端まで、順次接続される定圧ウォーターポンプ、流量制御弁、水力タービン及びアテレクトミーヘッドが設けられ、水力タービンが水車と動力伝達増速機構を連結することによって構成される。 As shown in FIG. 1, the atherectomy device for intravascular calcification lesions of the present invention is configured by sequentially connecting a constant pressure water pump, a flow control valve, a hydraulic turbine, and an atherectomy head from the proximal end to the distal end, and connecting the hydraulic turbine to a water wheel and a power transmission acceleration mechanism.

定圧ウォーターポンプの出力液体(水)の圧力は、50Mpa以上で、アテレクトミーヘッドの回転数が70000~150000rad/minの範囲である。操作者は、定圧ウォーターポンプの出力液圧、手術に必要なアテレクトミーヘッドの回転数に応じて、流量制御弁の出力ポートの直径サイズを調整して、流量制御弁の出口の大きさを制御し、流量制御弁の出力液体流量の調整を実現し、アテレクトミーヘッドの回転数を70000~150000rad/minの範囲内の適正値に制御することができる。 The pressure of the output liquid (water) of the constant pressure water pump is 50 MPa or more, and the rotation speed of the atherectomy head is in the range of 70,000 to 150,000 rad/min. The operator can adjust the diameter size of the output port of the flow control valve according to the output liquid pressure of the constant pressure water pump and the rotation speed of the atherectomy head required for the surgery, thereby controlling the size of the outlet of the flow control valve and adjusting the output liquid flow rate of the flow control valve, and controlling the rotation speed of the atherectomy head to an appropriate value within the range of 70,000 to 150,000 rad/min.

図2、図3、図4及び図5に示すように、水力タービンは、水車(図2内の右側部分、図4及び図5)と動力伝達増速機構(図2内の左辺部分と図3に示す)を連結することによって構成する。 As shown in Figures 2, 3, 4 and 5, the water turbine is constructed by connecting a water wheel (the right side part in Figure 2, Figures 4 and 5) and a power transmission speed increasing mechanism (the left side part in Figure 2 and shown in Figure 3).

図6及び図7に示すように、水車と動力伝達増速機構とアテレクトミーヘッドとは、同軸上に連結される。 As shown in Figures 6 and 7, the water wheel, power transmission acceleration mechanism, and atherectomy head are connected coaxially.

図8を参照すると、水車にシェルアセンブリ2が設けられ、シェルアセンブリ2内に水車回転子1が同軸に設けられる。 Referring to FIG. 8, a shell assembly 2 is provided on the water turbine, and a water turbine rotor 1 is coaxially provided within the shell assembly 2.

シェルアセンブリ2に円筒が設けられ、円筒の中央部が円筒よりも直径が小さいそれぞれ流入口、流出口である別の2つの円筒と半径方向に沿って接続され、図17及び図18に示すように流入口、流出口の軸線が30°~60°の角度を成し、かつ、流入口、流出口の軸線は円筒の軸線に垂直である。
A cylinder is provided in the shell assembly 2, and the center of the cylinder is connected along the radial direction to two other cylinders which have a smaller diameter than the cylinder and serve as an inlet and an outlet, respectively. As shown in Figures 17 and 18 , the axes of the inlet and outlet form an angle of 30° to 60°, and the axes of the inlet and outlet are perpendicular to the axis of the cylinder.

本実施例において、円筒の内径は、16~30mmの範囲を選択でき、外径が18~34mmであり得、流入口、流出口が円筒の軸線方向に沿った中央位置に設けられる。 In this embodiment, the inner diameter of the cylinder can be selected in the range of 16 to 30 mm, the outer diameter can be 18 to 34 mm, and the inlet and outlet are located in the center along the axial direction of the cylinder.

水車回転子1に中央軸が設けられ、中央軸の軸線に沿って貫通穴が設けられ、中央軸に少なくとも2つのブレードが連結され、水車回転子1はシェルアセンブリ2内に組み込まれ、水車回転子1の中央軸の軸線とシェルアセンブリ2の円筒の軸線が同軸である。 The water turbine rotor 1 is provided with a central shaft, a through hole is provided along the axis of the central shaft, at least two blades are connected to the central shaft, the water turbine rotor 1 is assembled in the shell assembly 2, and the axis of the central shaft of the water turbine rotor 1 is coaxial with the axis of the cylinder of the shell assembly 2.

図19及び図20を参照すると、本実施例においてブレードは、4つあり、その断面がL形を呈し、ステンレス鋼を用いる。L形ブレードの短辺は、それぞれ中央軸の軸方向に沿って中央軸と連結し、L形ブレードが同じ方向に向き、円周方向に沿って中央軸上に均一に分布している。水車回転子1の最大外径は、異なる円筒の内径に応じて15.8~29.8mmの範囲を選択でき、ブレードの高さが(水車回転子の最大外径値-中央軸の外径)/2=3.7mm、ブレードの長さが13mm、中央軸の長さが15mm、水車回転子1の最大外径の弧長(L形ブレードの長辺)が2mmであり、ブレードの厚さがL形ブレードの短辺端部からL形ブレードの長辺端部へ徐々に薄くなり、つまり1.85mmから0.9mmである。 Referring to Figures 19 and 20, in this embodiment, there are four blades, each of which has an L-shaped cross section and is made of stainless steel. The short sides of the L-shaped blades are connected to the central shaft along the axial direction of the central shaft, and the L-shaped blades face the same direction and are uniformly distributed on the central shaft along the circumferential direction. The maximum outer diameter of the water turbine rotor 1 can be selected in the range of 15.8 to 29.8 mm according to the inner diameter of different cylinders, the height of the blade is (maximum outer diameter value of the water turbine rotor - outer diameter of the central shaft) / 2 = 3.7 mm, the length of the blade is 13 mm, the length of the central shaft is 15 mm, the arc length of the maximum outer diameter of the water turbine rotor 1 (long side of the L-shaped blade) is 2 mm, and the thickness of the blade gradually decreases from the short side end of the L-shaped blade to the long side end of the L-shaped blade, that is, from 1.85 mm to 0.9 mm.

図21及び図22に示すように、水車回転子1はシェルアセンブリ2内に取り付けられ、水車回転子1の最大外径とシェルアセンブリ2の内径との差が0.2mmで、水車回転子1がシェルアセンブリ2の中央位置にあり、この構造は、水車回転子1がシェルアセンブリ2内で回転することで起きる液体キャビテーションを防止できる。 As shown in Figures 21 and 22, the water turbine rotor 1 is mounted inside the shell assembly 2, the difference between the maximum outer diameter of the water turbine rotor 1 and the inner diameter of the shell assembly 2 is 0.2 mm, and the water turbine rotor 1 is located in the center of the shell assembly 2. This structure can prevent liquid cavitation caused by the rotation of the water turbine rotor 1 inside the shell assembly 2.

水車回転子1の中央軸の両端がリング状のベアリングアセンブリ5の穴内に支持され、ベアリングアセンブリ5は、ベアリング押さえ板4を介してシェルアセンブリ2の円筒内に設けられる。ベアリング押さえ板4は、端面が開いた蓋形状を呈し、蓋端部がブレードに面する。ベアリング押さえ板4の蓋端部に円環状シール仕切板3が設けられる。水車回転子1の中央軸の両端部付近の外縁に円周方向に沿って環状シール溝が設けられ、シール溝内に防水環状ゴムパッキン8が嵌め込まれるように設けられる。二組のシール仕切板3、ベアリング押さえ板4、ベアリングアセンブリ5、防水パッキン8及びシェルアセンブリ2で密封した空洞部を画成し、前記密封した空洞部が水車回転子1の回転領域であり、密封した空洞部により水車回転子1は加圧された液体がブレードを洗い流す時中央軸を回転させる。 Both ends of the central shaft of the water turbine rotor 1 are supported in the holes of the ring-shaped bearing assembly 5, and the bearing assembly 5 is installed in the cylinder of the shell assembly 2 via the bearing presser plate 4. The bearing presser plate 4 has a lid shape with an open end, and the lid end faces the blades. An annular seal partition plate 3 is installed at the lid end of the bearing presser plate 4. An annular seal groove is provided along the circumferential direction on the outer edge near both ends of the central shaft of the water turbine rotor 1, and a waterproof annular rubber packing 8 is fitted into the seal groove. The two sets of seal partition plates 3, bearing presser plate 4, bearing assembly 5, waterproof packing 8, and shell assembly 2 define a sealed cavity, and the sealed cavity is the rotation area of the water turbine rotor 1, and the water turbine rotor 1 rotates the central shaft by the sealed cavity when pressurized liquid washes the blades.

水車回転子1の両端に環状の押さえ板6及び円形の底板7が設けられ、水車の全体的な構造を構成する。押さえ板6の外側、シェルアセンブリ2の円筒の内穴が雌ねじで、遊星ギアキャリアアセンブリ11とのねじ込み結合に用いられる。 An annular pressure plate 6 and a circular bottom plate 7 are provided on both ends of the turbine rotor 1, forming the overall structure of the turbine. On the outside of the pressure plate 6, the inner cylindrical hole of the shell assembly 2 is female-threaded and is used for screwing in connection with the planetary gear carrier assembly 11.

水車が動作する時、加圧された液体が流入口から流入し、ブレードを洗い流した後、流出口から流出される。流量制御弁の出口の大きさを調整することにより、水流量を調整して、水車回転子1の中央軸の回転数を制御できる。 When the turbine is operating, pressurized liquid flows in through the inlet, washes over the blades, and then flows out through the outlet. By adjusting the size of the outlet of the flow control valve, the water flow rate can be adjusted to control the rotation speed of the central shaft of the turbine rotor 1.

図9に示すように、動力伝達増速機構に六角軸9が設けられる。六角軸9は、水車回転子1の中央軸と取り外し可能に連結され、水車回転子1の中央軸の回転により生じるトルクを六角軸9に伝達する。六角軸9の水車回転子1の中央軸と連結する端の軸断面が六角形であり、水車回転子1の中央軸の貫通穴の対応する六角形と取り外し可能な連結を形成する。 As shown in FIG. 9, a hexagonal shaft 9 is provided in the power transmission acceleration mechanism. The hexagonal shaft 9 is removably connected to the central shaft of the water turbine rotor 1, and transmits the torque generated by the rotation of the central shaft of the water turbine rotor 1 to the hexagonal shaft 9. The shaft cross section of the end of the hexagonal shaft 9 that connects to the central shaft of the water turbine rotor 1 is hexagonal, and forms a removably connection with the corresponding hexagon of the through hole of the central shaft of the water turbine rotor 1.

六角軸9の中央の軸は、フランジベアリング10とベアリングアセンブリ19の内穴に設けられ、フランジベアリング10と隙間ばめを形成し、ベアリングアセンブリ19と締まりばめを形成する。ベアリングアセンブリ19の一端は、フランジベアリング10の一端に隣接し、フランジベアリング10の他端に位置規制用の環状ベアリングガード18及びサークリップ17が設けられる。フランジベアリング10及びベアリングアセンブリ19は、遊星ギアキャリア11の一端の内穴に嵌設され、遊星ギアキャリア11が円筒状であり、フランジベアリング10とベアリングアセンブリ19にある端が雄ねじで、シェルアセンブリ2の円筒の雌ねじとねじ込み結合を形成する。遊星ギアキャリア11の他端は、雌ねじである。 The central shaft of the hexagonal shaft 9 is fitted in the inner holes of the flange bearing 10 and the bearing assembly 19, forming a clearance fit with the flange bearing 10 and an interference fit with the bearing assembly 19. One end of the bearing assembly 19 is adjacent to one end of the flange bearing 10, and the other end of the flange bearing 10 is provided with an annular bearing guard 18 and a circlip 17 for position regulation. The flange bearing 10 and the bearing assembly 19 are fitted into the inner hole of one end of the planetary gear carrier 11, which is cylindrical, and the ends of the flange bearing 10 and the bearing assembly 19 are male threaded and form a screw-fit connection with the female thread of the cylinder of the shell assembly 2. The other end of the planetary gear carrier 11 is female threaded.

ベアリングアセンブリ19の他端、遊星ギアキャリア11内に一次遊星増速歯車機構及びその出力端と連結する二次遊星増速歯車機構が順次設けられる。 At the other end of the bearing assembly 19, a primary planetary speed-up gear mechanism and a secondary planetary speed-up gear mechanism connected to the output end are sequentially provided within the planetary gear carrier 11.

一次遊星増速歯車機構に一次遊星増速歯車底板12、3つの一次遊星増速歯車軸20及び連結される一次遊星増速歯車21、一次遊星増速歯車21と噛み合う一次遊星増速太陽歯車13が設けられる。一次遊星増速歯車底板12の軸方向断面は、T字形を呈し、軸方向中心貫通穴が六角軸9の他端と接続し、小端部が六角軸9に面し、大端部の端面に3つの均一に分布している貫通穴が穿設され、一次遊星増速歯車軸20の一端が各々3つの均一に分布している貫通穴内に固定配置され、一次遊星増速歯車軸20の他端に一次遊星増速歯車21が連結され、3つの一次遊星増速歯車21が一次遊星増速太陽歯車13と噛み合い、一次遊星増速太陽歯車13の軸線と一次遊星増速歯車底板12の軸方向中心貫通穴とが同軸である。一次遊星増速太陽歯車13の軸は、一次増速後の回転速度を出力する。 The primary planetary speed-increasing gear mechanism is provided with a primary planetary speed-increasing gear bottom plate 12, three primary planetary speed-increasing gear shafts 20, primary planetary speed-increasing gears 21 connected thereto, and a primary planetary speed-increasing sun gear 13 meshing with the primary planetary speed-increasing gear 21. The axial cross section of the primary planetary speed-increasing gear bottom plate 12 is T-shaped, with an axial central through hole connected to the other end of the hexagonal shaft 9, a small end facing the hexagonal shaft 9, and three uniformly distributed through holes drilled on the end face of the large end, one end of the primary planetary speed-increasing gear shafts 20 is fixedly disposed in each of the three uniformly distributed through holes, a primary planetary speed-increasing gear 21 is connected to the other end of the primary planetary speed-increasing gear shaft 20, the three primary planetary speed-increasing gears 21 mesh with the primary planetary speed-increasing sun gear 13, and the axis of the primary planetary speed-increasing sun gear 13 and the axial central through hole of the primary planetary speed-increasing gear bottom plate 12 are coaxial. The shaft of the primary planetary speed-increasing sun gear 13 outputs the rotational speed after the primary speed increase.

六角軸9が回転した時一次遊星増速歯車底板12を回転させ、一次遊星増速歯車底板12に均一に分布された3本の一次遊星増速歯車軸20が一次遊星増速歯車底板12の軸線を中心に回転させ、一次遊星増速歯車軸20に連結される一次遊星増速歯車21が一次遊星増速歯車底板12の軸線を中心に回転させ、一次遊星増速歯車21と噛み合う一次遊星増速太陽歯車13を回転させ、回転速度を出力する。 When the hexagonal shaft 9 rotates, it rotates the primary planetary speed-up gear base plate 12, causing the three primary planetary speed-up gear shafts 20 evenly distributed on the primary planetary speed-up gear base plate 12 to rotate around the axis of the primary planetary speed-up gear base plate 12, causing the primary planetary speed-up gear 21 connected to the primary planetary speed-up gear shafts 20 to rotate around the axis of the primary planetary speed-up gear base plate 12, rotating the primary planetary speed-up sun gear 13 meshing with the primary planetary speed-up gear 21 and outputting the rotational speed.

二次遊星増速歯車機構に二次遊星増速歯車底板22、3つの二次遊星増速歯車軸23及び連結される二次遊星増速歯車24、二次遊星増速歯車24と噛み合う二次遊星増速太陽歯車14が設けられる。二次遊星増速歯車底板22の軸方向断面は、T字形を呈し、軸方向中心貫通穴が一次遊星増速太陽歯車13の軸と接続し、小端部が一次遊星増速太陽歯車13に面し、大端部の端面に3つの均一に分布している貫通穴が穿設され、二次遊星増速歯車軸23の一端が各々3つの均一に分布している貫通穴内に固定配置され、二次遊星増速歯車軸23の他端に二次遊星増速歯車24が連結され、3つの二次遊星増速歯車24が二次遊星増速太陽歯車14と噛み合い、二次遊星増速太陽歯車14の軸線と一次遊星増速太陽歯車13の軸とが同軸である。二次遊星増速太陽歯車14の軸は、二次増速後の回転速度を出力する。二次遊星増速太陽歯車14に連結される出力軸の断面は、六角形である。 The secondary planetary speed-up gear mechanism is provided with a secondary planetary speed-up gear bottom plate 22, three secondary planetary speed-up gear shafts 23, secondary planetary speed-up gears 24 connected thereto, and a secondary planetary speed-up sun gear 14 meshing with the secondary planetary speed-up gear 24. The axial cross section of the secondary planetary speed-up gear bottom plate 22 is T-shaped, with an axial central through hole connected to the axis of the primary planetary speed-up sun gear 13, a small end facing the primary planetary speed-up sun gear 13, and three uniformly distributed through holes drilled on the end face of the large end, one end of the secondary planetary speed-up gear shafts 23 is fixedly disposed in each of the three uniformly distributed through holes, and the other end of the secondary planetary speed-up gear shaft 23 is connected to the secondary planetary speed-up gear 24, the three secondary planetary speed-up gears 24 mesh with the secondary planetary speed-up sun gear 14, and the axis of the secondary planetary speed-up sun gear 14 and the axis of the primary planetary speed-up sun gear 13 are coaxial. The shaft of the secondary planetary speed-increasing sun gear 14 outputs the rotational speed after secondary speed-increase. The cross section of the output shaft connected to the secondary planetary speed-increasing sun gear 14 is hexagonal.

一次遊星増速太陽歯車13は、二次遊星増速歯車底板22を回転させ、二次遊星増速歯車底板22に均一に分布された3本の二次遊星増速歯車軸23が二次遊星増速歯車底板22の軸線を中心に回転させ、二次遊星増速歯車軸23に連結される二次遊星増速歯車24が二次遊星増速歯車底板22の軸線を中心に回転させ、二次遊星増速歯車24と噛み合う二次遊星増速太陽歯車14を回転させ、回転速度を出力する。 The primary planetary speed-up sun gear 13 rotates the secondary planetary speed-up gear bottom plate 22, causing the three secondary planetary speed-up gear shafts 23 evenly distributed on the secondary planetary speed-up gear bottom plate 22 to rotate around the axis of the secondary planetary speed-up gear bottom plate 22, causing the secondary planetary speed-up gears 24 connected to the secondary planetary speed-up gear shafts 23 to rotate around the axis of the secondary planetary speed-up gear bottom plate 22, rotating the secondary planetary speed-up sun gear 14 meshing with the secondary planetary speed-up gears 24 and outputting a rotational speed.

二次遊星増速歯車機構の出力端に環状の潤滑油バッフルプレートアセンブリ15が設けられ、バッフルプレートアセンブリ15の外側に蓋板16が設けられ、蓋板16が遊星ギアキャリア11の他端の雌ねじとねじ込み結合される。 An annular lubricant baffle plate assembly 15 is provided at the output end of the secondary planetary speed-up gear mechanism, and a cover plate 16 is provided on the outside of the baffle plate assembly 15, and the cover plate 16 is screwed into the female threads at the other end of the planetary gear carrier 11.

図10に示すように、動力伝達増速機構の出力端に連結されるアテレクトミーヘッドに六角形の中空軸が設けられ、六角形の中空軸の一端は、二次遊星増速歯車機構の出力軸及び二次遊星増速太陽歯車14の出力軸と取り外し可能な連結構造を形成し、六角形の中空軸の他端がアテレクトミースパイラルチューブの一端と溶接接合される。 As shown in FIG. 10, a hexagonal hollow shaft is provided on the atherectomy head connected to the output end of the power transmission speed-up mechanism, one end of the hexagonal hollow shaft forms a removable connection structure with the output shaft of the secondary planetary speed-up gear mechanism and the output shaft of the secondary planetary speed-up sun gear 14, and the other end of the hexagonal hollow shaft is welded to one end of the atherectomy spiral tube.

図11、図12及び図13に示すように、アテレクトミースパイラルチューブは、少なくとも2本のステンレス鋼線を螺旋状に巻回することによって形成される。本実施例は、3本あり、1本のスパイラル鋼線のピッチP=0.5mm、外径OD=0.8255mm、内径ID=0.495mm、ステンレス鋼線の外径d=0.165mm、螺旋角α=11°となり、回転方向が右回りである。ステンレス鋼線を螺旋状に巻回した後、2000℃以上の温度で成形熱処理してから得られ、優れたトルク伝達能力、良好な曲げ能力を持つため、血管の複雑な屈曲部を通過できる。 As shown in Figures 11, 12 and 13, the atherectomy spiral tube is formed by winding at least two stainless steel wires in a spiral shape. In this embodiment, there are three wires, and each spiral steel wire has a pitch P of 0.5 mm, an outer diameter OD of 0.8255 mm, an inner diameter ID of 0.495 mm, an outer diameter d of the stainless steel wire of 0.165 mm, a spiral angle α of 11°, and a clockwise rotation direction. After winding the stainless steel wire in a spiral shape, it is heat-treated to form at a temperature of 2000°C or higher, and has excellent torque transmission ability and good bending ability, so it can pass through the complex bends of blood vessels.

図14に示すように、アテレクトミースパイラルチューブの他端にアテレクトミーヘッドが設けられ、アテレクトミーヘッドは、アテレクトミースパイラルチューブの遠位端付近に外嵌され、アテレクトミースパイラルチューブの遠位端がアテレクトミーヘッドから突き出し、レーザ溶接で接合する。アテレクトミーヘッドの軸方向断面は、ひょうたん形で、ひょうたん形の小端部が遠位端に面し、アテレクトミースパイラルチューブの軸線がアテレクトミーヘッドの軸線と重なる。この形状のアテレクトミーヘッド構造は、血管中の正方向狭窄の大面積閉塞(詰まり)の状態に適する。 As shown in FIG. 14, an atherectomy head is provided at the other end of the atherectomy spiral tube, and the atherectomy head is fitted around the distal end of the atherectomy spiral tube, with the distal end of the atherectomy spiral tube protruding from the atherectomy head and joined by laser welding. The axial cross section of the atherectomy head is gourd-shaped, with the small end of the gourd facing the distal end, and the axis of the atherectomy spiral tube overlapping the axis of the atherectomy head. This shape of the atherectomy head structure is suitable for a large area occlusion (clogging) of a positive stenosis in a blood vessel.

図15に示すように、アテレクトミーヘッドの軸方向断面は、台形と矩形の組み合わせた後の形状であり、台形の底部が矩形の長辺と重なり、アテレクトミースパイラルチューブの軸方向断面が矩形と重なり、アテレクトミースパイラルチューブの軸方向断面の上部外縁がアテレクトミーヘッドの台形の底部と重なることで、偏心アテレクトミーヘッドを構成させる。アテレクトミースパイラルチューブは、アテレクトミーヘッドの遠位端から2~3cm突き出す。この形状のアテレクトミーヘッドは、血管中の正方向狭窄の大面積閉塞(詰まり)を削り取ることを目的とし、血管壁の片側石灰化病変及び血管分岐部石灰化病変の改善に適する。 As shown in FIG. 15, the axial cross section of the atherectomy head is a shape obtained by combining a trapezoid and a rectangle, with the bottom of the trapezoid overlapping the long side of the rectangle, the axial cross section of the atherectomy spiral tube overlapping the rectangle, and the upper outer edge of the axial cross section of the atherectomy spiral tube overlapping the bottom of the trapezoid of the atherectomy head, thereby forming an eccentric atherectomy head. The atherectomy spiral tube protrudes 2-3 cm from the distal end of the atherectomy head. This shape of the atherectomy head is intended to scrape off large area occlusions (blockages) of forward stenosis in blood vessels, and is suitable for improving unilateral calcified lesions of blood vessel walls and calcified lesions at blood vessel bifurcations.

図16に示すように、アテレクトミーヘッドの軸方向断面の遠位端は、ひょうたん形の小端形状であり、ひょうたん形の小端部が遠位端に面し、アテレクトミースパイラルチューブの軸線がひょうたん形の軸線と重なり、ひょうたん形小端の大きな外径を小端部とし、軸方向に沿って近位端に向けて第1円錐形を延在し、第1円錐形の大端部が円柱状に延在し、円柱状の外径を大端部として近位端に沿って第2円錐形を延在し、第2円錐形の小端部を第3円錐形の大端部とし、近位端に沿って第3円錐形を延在し、円柱状の長さが第1円錐形の軸方向の長さよりも短く、アテレクトミーヘッドの軸方向断面の下部が軸方向に沿って切り取られ、その下部外縁が第1円錐形の小端部の外径と同じになり、第3円錐形の大端部まで、偏心アテレクトミーヘッドを構成させる。この形状のアテレクトミーヘッドは、正方向狭窄を開通できるだけではく、血管壁上の石灰化病変を改善させると共に分岐部病変の状況も配慮できる。 As shown in FIG. 16, the distal end of the axial cross section of the atherectomy head has a gourd-shaped small end shape, the small end of the gourd shape faces the distal end, the axis of the atherectomy spiral tube overlaps with the axis of the gourd shape, the larger outer diameter of the small end of the gourd shape is the small end, a first cone extends along the axial direction toward the proximal end, the large end of the first cone extends cylindrically, a second cone extends along the proximal end with the outer diameter of the cylinder as the large end, the small end of the second cone is the large end of a third cone, and the third cone extends along the proximal end, the length of the cylinder is shorter than the axial length of the first cone, the lower part of the axial cross section of the atherectomy head is cut along the axial direction, and the lower outer edge of the cutout is the same as the outer diameter of the small end of the first cone, forming an eccentric atherectomy head up to the large end of the third cone. This shape of atherectomy head not only opens forward stenosis, but also improves calcified lesions on the blood vessel wall and takes into account the condition of bifurcation lesions.

本発明は、液体の運動エネルギーを介してアテレクトミーヘッド回転の機械的エネルギーに変換することによって、末梢動脈又は冠動脈内の完全閉塞病変を削り取るか、或いは改善する。液体の動力は、空気圧駆動及びモータ駆動に比べ、同じのアテレクトミー施行効果を奏し、アテレクトミーヘッドを病変治療に必要な高回転数要件を満たさせるだけではなく、アテレクトミーヘッドの高速回転状態下で伝動騒音を低減し、アテレクトミー施行によってもたらされる人体内に滞留する摩擦熱を低減し、人体への冷却と潤滑溶液の投与量を減らし、人体の腎臓代謝負荷を軽減し、手術の安全性も向上する。 The present invention scrapes off or improves completely occluded lesions in peripheral or coronary arteries by converting the kinetic energy of liquid into mechanical energy of atherectomy head rotation. Compared with air pressure drive and motor drive, liquid power not only achieves the same atherectomy effect and allows the atherectomy head to meet the high rotation speed requirements required for lesion treatment, but also reduces the transmission noise when the atherectomy head is rotating at high speed, reduces the frictional heat retained in the human body caused by atherectomy, reduces the amount of cooling and lubricating solution administered to the human body, reduces the metabolic burden on the human kidney, and improves the safety of surgery.

本発明は、定圧ウォーターポンプを用いて出力水圧が50Mpa以上にさせ、流量制御弁の出力ポートの直径サイズを調整して、流量制御弁の出口の大きさを制御し、流量制御弁の出力液体流量の調整を実現し、水車を駆動して水流の運動エネルギーを機械的エネルギーに変換し、動力伝達増速機構によって増速された後、アテレクトミーヘッドの回転数を70000~150000rad/minの範囲に制御する。構造は単純で、コストも低く、安全で信頼性の高い操作が可能である。 The present invention uses a constant pressure water pump to make the output water pressure 50 MPa or more, adjusts the diameter size of the output port of the flow control valve to control the size of the outlet of the flow control valve, and adjusts the output liquid flow rate of the flow control valve. It drives a water wheel to convert the kinetic energy of the water flow into mechanical energy, and after being accelerated by the power transmission acceleration mechanism, controls the rotation speed of the atherectomy head to a range of 70,000 to 150,000 rad/min. The structure is simple, the cost is low, and it is possible to operate it safely and reliably.

Claims (5)

アテレクトミーヘッドを設けた血管内石灰化病変用アテレクトミーデバイスであって、前記アテレクトミーヘッドは、ウォーターポンプを用いて水力タービンの駆動によって回転され、
前記水力タービンは、水車と動力伝達増速機構とから構成されると共に、
前記水車と前記動力伝達増速機構と前記アテレクトミーヘッドとは、同軸上に連結され、
前記ウォーターポンプは、定圧ウォーターポンプであり、
前記水車には前記定圧ウォーターポンプで加圧された流体が流入する流入口と、前記流体により中央軸を回転する水車回転子と、流体が流出する流出口とを備え、
前記定圧ウォーターポンプが流量制御弁、前記水力タービンを介して前記アテレクトミーヘッドに接続され、
前記流量制御弁の制御により、前記定圧ウォーターポンプの出力液圧が50Mpa以上で、前記アテレクトミーヘッドの回転数が70000~150000rad/minの範囲で、前記流量制御弁から前記流入口に向かう出力液体流量を調整し、前記アテレクトミーヘッドの回転数を70000~150000rad/min範囲の特定の値に制御され、
前記水車にシェルアセンブリ(2)が設けられ、前記シェルアセンブリ(2)内に前記水車回転子(1)が同軸に設けられ、前記シェルアセンブリ(2)の円筒の内径は、16~30mmの範囲、外径が18~34mmの範囲であり、円筒の中央部が円筒よりも直径が小さいそれぞれ前記流入口、前記流出口である別の2つの円筒と半径方向に沿って接続され、流入口、流出口の軸線が30°~60°の角度を成し、かつ、前記流入口、前記流出口の軸線は円筒の軸線に垂直であり、;前記水車回転子(1)に前記中央軸が設けられ、前記中央軸の軸線に沿って貫通穴が設けられ、前記中央軸に少なくとも2つのブレードが連結され、
前記動力伝達増速機構は、一次遊星増速歯車機構と二次遊星増速歯車機構とを連結し、前記アテレクトミーヘッドに六角形の中空軸が設けられ、前記六角形の中空軸の一端は、前記二次遊星増速歯車機構の出力軸と取り外し可能な連結構造を形成し、他端がアテレクトミースパイラルチューブの一端に連結され、前記アテレクトミースパイラルチューブの他端に前記アテレクトミーヘッドが外嵌され、前記アテレクトミースパイラルチューブが前記アテレクトミーヘッドから突き出す
ことを特徴とする、血管内石灰化病変用アテレクトミーデバイス。
An atherectomy device for intravascular calcification lesions, comprising an atherectomy head, the atherectomy head being rotated by driving a water turbine using a water pump;
The hydraulic turbine is composed of a water wheel and a power transmission speed increasing mechanism,
The water wheel, the power transmission speed increasing mechanism, and the atherectomy head are coaxially connected to each other,
The water pump is a constant pressure water pump,
The water turbine has an inlet through which the fluid pressurized by the constant pressure water pump flows in, a water turbine rotor that rotates a central shaft by the fluid, and an outlet through which the fluid flows out,
the constant pressure water pump is connected to the atherectomy head via a flow control valve and the water turbine;
By controlling the flow control valve, the output liquid flow rate from the flow control valve toward the inlet is adjusted when the output liquid pressure of the constant pressure water pump is 50 MPa or more and the rotation speed of the atherectomy head is in the range of 70,000 to 150,000 rad/min, and the rotation speed of the atherectomy head is controlled to a specific value in the range of 70,000 to 150,000 rad/min;
The water turbine is provided with a shell assembly (2), the water turbine rotor (1) is coaxially provided within the shell assembly (2), the inner diameter of the cylinder of the shell assembly (2) is in the range of 16 to 30 mm, the outer diameter is in the range of 18 to 34 mm, the center of the cylinder is connected along a radial direction to two other cylinders, which are the inlet and the outlet, respectively, having a smaller diameter than the cylinder, the axes of the inlet and the outlet form an angle of 30° to 60°, and the axes of the inlet and the outlet are perpendicular to the axis of the cylinder; the water turbine rotor (1) is provided with the central shaft, a through hole is provided along the axis of the central shaft, and at least two blades are connected to the central shaft;
an atherectomy device for intravascular calcified lesions, characterized in that the power transmission speed-up mechanism connects a primary planetary speed-up gear mechanism and a secondary planetary speed-up gear mechanism, the atherectomy head is provided with a hexagonal hollow shaft, one end of the hexagonal hollow shaft forms a removable connecting structure with an output shaft of the secondary planetary speed-up gear mechanism and the other end is connected to one end of an atherectomy spiral tube, the atherectomy head is fitted onto the other end of the atherectomy spiral tube, and the atherectomy spiral tube protrudes from the atherectomy head.
前記水力タービンは、水車と動力伝達増速機構を連結することよって構成されることを特徴とする、請求項1に記載の血管内石灰化病変用アテレクトミーデバイス。 The atherectomy device for intravascular calcified lesions according to claim 1, characterized in that the water turbine is constructed by connecting a water wheel and a power transmission acceleration mechanism. 前記アテレクトミーヘッドの軸方向断面は、ひょうたん形であり、ひょうたん形の小端部が遠位端に面し、前記アテレクトミースパイラルチューブの軸線が前記アテレクトミーヘッドの軸線と重なることを特徴とする、請求項1に記載の血管内石灰化病変用アテレクトミーデバイス。 The atherectomy device for intravascular calcified lesions according to claim 1, characterized in that the axial cross section of the atherectomy head is gourd-shaped, the small end of the gourd faces the distal end, and the axis of the atherectomy spiral tube overlaps with the axis of the atherectomy head. 前記アテレクトミーヘッドの軸方向断面は、台形と矩形の組み合わせた後の形状であり、台形の底部が矩形の長辺と重なり、前記アテレクトミースパイラルチューブの軸方向断面が矩形と重なり、前記アテレクトミースパイラルチューブの軸方向断面の上部外縁が前記アテレクトミーヘッドの台形の底部と重なることで、偏心アテレクトミーヘッドを構成させることを特徴とする、請求項1に記載の血管内石灰化病変用アテレクトミーデバイス。 The atherectomy device for intravascular calcified lesions according to claim 1, characterized in that the axial cross section of the atherectomy head has a shape obtained by combining a trapezoid and a rectangle, the bottom of the trapezoid overlaps with the long side of the rectangle, the axial cross section of the atherectomy spiral tube overlaps with the rectangle, and the upper outer edge of the axial cross section of the atherectomy spiral tube overlaps with the bottom of the trapezoid of the atherectomy head, thereby forming an eccentric atherectomy head. 前記アテレクトミーヘッドの軸方向断面の遠位端は、ひょうたん形の小端形状であり、前記アテレクトミースパイラルチューブの軸線がひょうたん形の軸線と重なり、ひょうたん形小端の大きな外径を小端部とし、軸方向に沿って近位端に向けて第1円錐形を延在し、前記第1円錐形の大端部が円柱状に延在し、円柱状の外径を大端部として近位端に沿って第2円錐形を延在し、前記第2円錐形の小端部を第3円錐形の大端部とし、近位端に沿って前記第3円錐形を延在し、円柱状の長さが前記第1円錐形の軸方向の長さよりも短く、前記アテレクトミーヘッドの軸方向断面の下部が軸方向に沿って切り取られ、その下部外縁が前記第1円錐形の小端部の外径と同じになり、前記第3円錐形の大端部まで、偏心アテレクトミーヘッドを構成させることを特徴とする、請求項1に記載の血管内石灰化病変用アテレクトミーデバイス。 The atherectomy device for intravascular calcification lesions according to claim 1, characterized in that the distal end of the atherectomy head in the axial cross section is a gourd-shaped small end shape, the axis of the atherectomy spiral tube overlaps with the axis of the gourd shape, the larger outer diameter of the gourd-shaped small end is the small end, a first cone extends along the axial direction toward the proximal end, the large end of the first cone extends cylindrically, the second cone extends along the proximal end with the outer diameter of the cylinder as the large end, the small end of the second cone is the large end of a third cone, the third cone extends along the proximal end, the length of the cylinder is shorter than the axial length of the first cone, the lower part of the axial cross section of the atherectomy head is cut along the axial direction, the lower outer edge is the same as the outer diameter of the small end of the first cone, and an eccentric atherectomy head is formed up to the large end of the third cone.
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