Puncture unit and medical drainage device using the same

The puncture unit with a motor-driven screw needle effectively addresses the inefficiencies of conventional methods by rapidly aspirating viscous fluids, enhancing surgical efficiency and safety.

JP7881169B2Active Publication Date: 2026-06-29KANSAI MEDICAL UNIVERSITY

Patent Information

Authority / Receiving Office
JP · JP
Patent Type
Patents
Current Assignee / Owner
KANSAI MEDICAL UNIVERSITY
Filing Date
2022-07-01
Publication Date
2026-06-29

AI Technical Summary

Technical Problem

Conventional methods for aspirating and removing highly viscous fluids, such as those found in ovarian cysts and peritonitis, are inefficient and can lead to prolonged surgical times due to slow suction speeds and the risk of iatrogenic complications from fluid dilution.

Method used

A puncture unit with a screw needle that rotates within a conduit, driven by a motorized rotary introducer, which efficiently crushes and aspirates viscous fluids using a minimally invasive approach.

Benefits of technology

The device enables rapid and efficient aspiration of highly viscous fluids with reduced invasiveness and surgical time, minimizing the risk of complications.

✦ Generated by Eureka AI based on patent content.

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Patent Text Reader

Abstract

To efficiently suction and remove storage liquid in body with high viscosity in a short time by means of a low invasive method with a simple and inexpensive device configuration.SOLUTION: A puncture unit comprises: a conduit tube 12 in which at least a tip thereof can be inserted to a subject, and which can be connected with a suction device 60 so as to be communicate to a tube lumen 12a on the rear side of a base end; a screw needle 22 which extends in the tube axis Ax direction to at least the base end of the conduit tube 12 from the tip opening of the conduit tube 12 in a state of being rotatable around the tube axis Ax in the tube lumen 12a of the conduit tube 12; and driving force acquisition means 21 which is located on the rear side of the base end of the conduit tube 12, is connected to a base end 22b of the screw needle and acquires driving force of rotating the screw needle 22.SELECTED DRAWING: Figure 2
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Description

Technical Field

[0001] The present disclosure relates to a medical drainage device for aspirating and removing lesions and retained fluid in the surgical field, and particularly to a medical drainage device used for aspirating and removing highly viscous body retained fluid.

Background Art

[0002] In the medical field, there are many diseases that cause fluid retention in lesions or the surgical field, such as ovarian cysts, peritonitis, empyema, etc., and it is necessary to aspirate and remove the retained fluid in the body during surgery (drainage).

[0003] Conventionally, for aspirating and removing the retained fluid in the body, a method has been adopted in which a suction nozzle tube with a hole at the tip is connected to an external suction device by a suction tube circuit to aspirate and remove the retained liquid (for example, Patent Document 1).

[0004] However, in recent years, percutaneous or transvaginal abscess drainage for adaptive diseases such as intra-abdominal abscess, empyema or subcutaneous abscess, percutaneous or transvaginal drainage for the retention of intra-abdominal hemorrhage, percutaneous puncture drainage for intracranial hematoma, transvaginal drainage for ovarian cysts or ovarian hematoma, CT-guided drainage for retroperitoneal abscess, or cesarean section wound abscess, etc., in the treatment of performing drainage percutaneously or transvaginally for adaptive diseases that require drainage of viscous liquid retention, further response to minimally invasive medicine is required.

[0005] Conventionally, as a means for aspirating and removing these lesions less invasively than a suction tube, puncture aspiration removal with a hollow needle has been adopted, and mainly, a method of puncturing with an 18-gauge hollow needle and aspirating and removing the retained liquid with a continuous suction bag has been proposed (for example, Patent Document 2).

Prior Art Documents

Patent Documents

[0006]

Patent Document 1

[0007] However, for example, ovarian cysts can contain semi-solid contents such as fat or highly viscous fluid, and peritonitis and pyothorax can involve the accumulation of large amounts of highly viscous pus over a wide area. In such cases, using the conventional method of drainage with a hollow needle can result in extremely slow suction speeds or make suction extremely difficult due to the viscosity of the fluid. In such cases, physiological saline may be injected into the abscess lumen to dilute the abscess before suction, but this method carries the risk of iatrogenic complications such as expanding the infection site or inducing retrograde infection. Furthermore, because suction removal is difficult, the procedure may have to be interrupted after only the placement of the drainage device, increasing surgical time and hindering efficiency.

[0008] This disclosure has been made in view of the above-mentioned problems, and aims to provide a puncture unit and a medical drainage device that can efficiently aspirate and remove highly viscous fluids accumulated in the body in a short time using a simple and inexpensive device configuration and a minimally invasive method. [Means for solving the problem]

[0009] To achieve the above objective, a puncture unit according to one aspect of the present disclosure is a puncture unit for transferring fluid stored in the body to the outside of the body, comprising: a conduit whose tip is capable of puncturing a subject and to which a suction device can be connected so as to communicate with the lumen of the conduit at the rear of the proximal end; a screw needle extending in the axial direction of the conduit from the tip opening of the conduit to at least the proximal end of the conduit, in a state in which it is rotatable about the axis of the conduit; and a driving force acquisition means located at the rear of the proximal end of the conduit and connected to the proximal end of the screw needle, which acquires a driving force to rotate the screw needle. The drive force acquisition means is connected to the base end of the conduit, and the internal space of the conduit is in communication with the internal space of the conduit, and the drive force acquisition means receives the drive force supplied from outside the conduit base non-contact through the outer casing of the conduit base, and transmits the drive force to the screw needle.It is characterized by the following:

[0010] Furthermore, a medical drainage device according to one aspect of the present disclosure comprises the puncture unit described above and a rotary introducer, wherein the rotary introducer has a housing to which the puncture unit can be detachably attached, a motor disposed in the housing that generates rotational driving force, and a driving force supply means disposed on the output shaft of the motor, which is opposite to the driving force acquisition means of the puncture unit mounted on the main body and the outer casing of the conduit base, and the driving force supplied from the driving force supply means is transmitted to the driving force acquisition means non-contact via the outer casing of the conduit base. [Effects of the Invention]

[0011] According to one aspect of the present disclosure, a puncture unit and a medical drainage device can be realized that efficiently aspirates and removes highly viscous fluid accumulated in the body in a short time using a simple and inexpensive device configuration in a minimally invasive manner. [Brief explanation of the drawing]

[0012] [Figure 1] Figures (a) to (c) are schematic diagrams illustrating the intraoperative use of the medical drainage device 1 according to the embodiment. [Figure 2] (a) is a side view of the medical drainage device 1, and (b) is a side view of the drainage device 1 separated into its main components. [Figure 3] This is a side cross-sectional view showing the configuration of the medical drainage device 1. [Figure 4] This is a side cross-sectional view showing the configuration of the portion of the puncture unit 15 that is inserted into the body. [Figure 5] This is an enlarged cross-sectional view showing details of the connection between the puncture unit 15 and the driving force supply means 40, where (a) shows the separated state and (b) shows the connected state. [Figure 6] This is a schematic diagram illustrating the operation of transmitting driving force from the driving force supply means 40 to the driving force acquisition means 21. [Figure 7] (a) is a plan view showing the medical drainage device 1 separated into a puncture unit 15, a holder means 30, and a rotary introducer 50, and (b) is a side view. [Figure 8] (a) is a plan view of the medical drainage device 1 showing the state where the proximal end of the puncture unit 15 is inserted into the distal end of the holder means 30, and (b) is a side view. [Figure 9] (a) is a plan view of the medical drainage device 1 showing the state where the driving force supply means 40 of the rotary introducer 50 is inserted into the proximal end of the holder means 30 with the puncture unit 15 mounted and positioned with respect to the driving force acquisition means 21, and (b) is a side view. [Figure 10] (a) to (c) are side cross-sectional views for explaining the drainage operation by the medical drainage device 1. [Figure 11] It is a photograph of the medical drainage device 1 according to the embodiment. [Figure 12] It is a photograph of the medical drainage device 1 according to the embodiment separated into units, where (a) is the puncture unit 15, (b) is the holder means 30, and (c) is a photograph of the rotary introducer 50 including the driving force supply means 40. [Figure 13] (a) and (b) are photographs of the puncture unit 15 according to the embodiment separated into an outer tube sub-unit 10 and an inner needle sub-unit 20. [Figure 14] (a) to (c) are photographs showing the results of a drainage test using the medical drainage device 1 and Comparative Example 1X. [Figure 15] It is a photograph showing the mode of a drainage test using a tray. [Figure 16] (a) to (c) are photographs showing the results of another drainage test using the medical drainage device 1 and Comparative Example 1X. [Figure 17] It is a side cross-sectional view showing the configuration of the puncture unit 15A used in the medical drainage device according to the modification.

Mode for Carrying Out the Invention

[0013] <<Summary of Modes for Carrying Out the Present Invention>> A puncture unit according to an embodiment of the present disclosure is a puncture unit for transferring a stored fluid in the body to the outside. The puncture unit includes a conduit at least the tip of which can be punctured into a subject and to which a suction device can be connected so as to communicate with the lumen at the rear of the proximal end, and a screw needle that extends in the axial direction of the conduit from the tip opening of the conduit to at least the proximal end of the conduit in a rotatable state around the axis of the conduit in the lumen of the conduit, and driving force acquisition means that is located behind the proximal end of the conduit and is connected to the proximal end of the screw needle and acquires a driving force for rotating the screw needle.

[0014] Further, the stored fluid in the body may be configured to be crushed by the rotation of the screw needle and taken into the conduit from the tip opening of the conduit, transferred at least to the proximal end of the conduit as the screw needle rotates, and suction-transferred by the negative pressure of the suction device.

[0015] With such a configuration, a puncture unit that can efficiently suck and remove a highly viscous stored fluid in the body in a short time by a minimally invasive method using the conduit as an injection needle can be realized with a simple and inexpensive device configuration.

[0016] In another aspect, in any of the above aspects, a hollow bag-shaped conduit base is provided that is connected to the proximal end of the conduit, the lumen of the conduit and the internal space communicate with each other, and an exhaust pipe extending from the outer shell is configured to be connectable to the suction device. The driving force acquisition means is arranged in the internal space of the conduit base in a rotatable state around the axis of the conduit, receives the driving force supplied from the outside of the conduit base in a non-contact manner, and transmits the driving force to the screw needle. The stored fluid in the body may be configured to be transferred to the internal space of the conduit base as the screw needle rotates, sucked by the suction device, and transferred outside the internal space.

[0017] With this configuration, the tip of the screw needle functions as a rotating drill, finely crushing the fluid stored in the body. The crushed fluid is then drawn into the lumen of the conduit and efficiently transferred to the proximal end by the spiral structure and negative pressure. Furthermore, the fluid transferred to the internal space at the base of the conduit can be drawn out by the negative pressure of the suction device and discharged from the internal space at the base of the conduit.

[0018] In another embodiment, in any of the above embodiments, a portion of the tip of the screw needle may be exposed from the opening at the tip of the conduit.

[0019] In another embodiment, in any of the above embodiments, the cutting surface at the tip of the conduit may be inclined with respect to the axis, and the tip of the screw needle may be located within the range of the cutting surface in the direction of the tube axis.

[0020] With this configuration, during the puncture process, the tip of the conduit's cutting surface can efficiently puncture the subject's tissue. In addition, during the drainage process, semi-solid contents of the body, such as fat and highly viscous fluids, can be finely crushed by the tip of the screw needle and taken into the lumen of the conduit, and efficiently transported to the proximal end as the screw needle rotates.

[0021] In another embodiment, in any of the above embodiments, the screw needle may be configured to consist of multiple strands of core wires twisted together at a predetermined pitch.

[0022] This configuration makes it possible to manufacture a screw needle that is highly hard and elastic, and can be rotatably inserted into the lumen of an injection needle.

[0023] In another embodiment, the conduit may be configured to consist of an injection needle in any of the above embodiments.

[0024] With this configuration, the puncture unit's conduit can be concretely realized with a simple configuration using a straight metal injection needle.

[0025] In another embodiment, in any of the above embodiments, the conduit may be configured such that the tip region including the front end and the rear end region including the rear end are made of a rigid tube, and the intermediate region between the tip region and the rear end region is made of a flexible tube made of a material that is less hard and more flexible than the rigid tube.

[0026] This configuration allows for the creation of a puncture unit that facilitates puncture procedures using a rigid tube while minimizing the risk of damage to the lungs or pelvic organs using a flexible tube. Furthermore, by inserting the flexible tube puncture unit into a blood vessel, it can be applied to the removal of intravascular thrombi, for example, in transcatheter pulmonary thrombolysis for pulmonary embolism.

[0027] A medical drainage device according to an embodiment of the present disclosure comprises a puncture unit in any of the above-described forms and a rotary introduction device, wherein the rotary introduction device has a housing to which the puncture unit can be detachably attached, a motor disposed in the housing that generates rotational driving force, and a driving force supply means connected to the output shaft of the motor, which faces the driving force acquisition means and the outer casing of the conduit base when the puncture unit is attached to the housing, and the driving force supplied from the driving force supply means is transmitted to the driving force acquisition means non-contact via the outer casing of the conduit base.

[0028] This configuration allows for the realization of a medical drainage device that efficiently aspirates and removes highly viscous fluids accumulated throughout the body in a short time using a simple and inexpensive device configuration and a minimally invasive method with a conduit acting as an injection needle.

[0029] In another embodiment, in any of the above embodiments, the driving force supply means and the driving force acquisition means may be configured as a magnetic coupling, magnetically coupled by a pair of opposing magnets arranged on each, and the driving force acquisition means may be configured to follow the driving rotation of the driving force supply means.

[0030] With this configuration, rotational force can be transmitted to the drive force acquisition means without contact, while the outer casing of the conduit base is sandwiched between them. Therefore, drainage can be performed by transmitting drive force from the drive force supply means 40 to the drive force acquisition means without causing leakage of stored liquid from the conduit base.

[0031] In another embodiment, the puncture unit may be mounted on the rotary guide so that the screw needle is positioned in the axial direction of the conduit such that a portion of the tip of the screw needle is exposed from the opening at the tip of the conduit.

[0032] With this configuration, when performing a puncture, the tip of the screw needle sinks into the opening at the end of the conduit, and the blade surface of the conduit cuts through the tissue, allowing for efficient puncture. Furthermore, in drainage performed with the puncture unit attached to a rotary guide, the tip of the screw needle finely breaks up the highly viscous fluid accumulated in the body, allowing it to be efficiently drawn into the lumen of the conduit.

[0033] In another embodiment, in any of the above embodiments, a holder means may be provided between the puncture unit and the rotary guide, and when the puncture unit is mounted on the rotary guide, the conduit base may fit into the holder means, thereby preventing the conduit base from rotating together with the screw needle.

[0034] This configuration allows the conduit base to be positioned in a predetermined location on the rotary inlet, and also stabilizes the operation of the conduit base relative to the screw needle.

[0035] In another embodiment, in any of the above embodiments, the rotary introduction device may be configured to have a switch that can be operated by the operator, which allows for independent switching of the rotation / stop of the motor and the biasing / release of negative pressure by the suction device.

[0036] Conventionally, the switch controlling the activation / deactivation of negative pressure by the suction device was located outside the operating room, requiring the surgeon to give instructions from outside the operating room, making the operation cumbersome. In contrast, the above-described configuration allows the surgeon to operate the activation / deactivation of negative pressure by the suction device independently, facilitating quick operation and enabling instantaneous switching of operation.

[0037] In another embodiment, in any of the above embodiments, the fluid accumulated in the body may consist of any of the following: an intra-abdominal abscess, empyema, subcutaneous abscess, accumulation of intra-abdominal hemorrhage, intracranial hematoma, ovarian cyst, ovarian hematoma, retroperitoneal abscess, or cesarean section wound abscess.

[0038] This configuration makes it possible to minimize invasiveness in percutaneous and transvaginal drainage procedures for indications involving viscous fluid accumulation and requiring drainage.

[0039] <Embodiment> A medical drainage device 1 according to this embodiment will be described with reference to the drawings. Note that the drawings are schematic diagrams and their scale may differ from that of actual devices. Furthermore, the following description is illustrative to explain the configuration and operation / effects of one aspect of this disclosure and is not limited to the following forms other than the essential parts of this disclosure. Also, including the following description, the up and down directions in this specification and the claims indicate relative positional relationships, with the direction at the top of the paper being the "up" direction and the direction at the bottom of the paper being the "down" direction. Furthermore, the direction towards the tip along the axial direction of the tube of the medical drainage device 1 is the "front" direction and the direction towards the base end is the "back" direction. However, this does not necessarily coincide with an absolute (vertical) up and down positional relationship. Furthermore, in this specification and the claims, the symbol "~" used to indicate a numerical range includes the numerical values ​​at both ends.

[0040] <Overall configuration of medical drainage device 1> Medical drainage device 1 (hereinafter referred to as "drainage device 1") is a medical instrument used by physicians and other medical professionals to aspirate and remove accumulated fluid from the surgical site or surgical field. From the perspective of reducing the burden on patients and physicians during surgery and improving the efficiency of surgery, it aims to facilitate and improve the efficiency of aspirating and removing highly viscous fluids from the body in a minimally invasive manner.

[0041] Figures 1(a) to 1(c) are schematic diagrams illustrating the intraoperative use of the drainage device 1 according to the embodiment. As shown in Figure 1(a), in drainage targeting internal fluid (tumor fluid) accumulated in an ovarian cyst corresponding to the abscess cavity L, the physician first uses a puncture guide G to perform a puncture with the puncture unit 15 toward the abscess cavity L (Figure 1(b)). Next, a suction tube 61 is connected to the puncture unit 15 to form a drainage channel to the suction device 60, and the puncture unit 15 is connected to the rotary inlet 50 via the holder means 30 to configure the suction system (Figure 1(c)). In this state, the rotary inlet 50 is operated with negative pressure applied by the suction device 60 to aspirate and remove the accumulated fluid from the body.

[0042] Here, the puncture guide G is a guiding means that facilitates access to the surgical site for the drainage device 1 by inserting its tip into the abdominal wall to secure a conduit to the surgical site.

[0043] The suction device 60 is connected to the drainage device 1 and is a suction means for aspirating and removing accumulated fluid from the body by applying negative pressure to the surgical site. The suction device 60 may consist of, for example, a negative pressure tank outside the operating room (operating room suction device: for example, -0.04 to -0.07 MPa).

[0044] The suction tube 61 is made of polyvinyl chloride tubing, resin, metal, etc., and connects the drainage device 1 and the suction device 60 to form a suction tube circuit. Needless to say, the tube diameter and material are not limited.

[0045] <Components of Drainage Device 1> Next, the components of the drainage device 1 will be described. Figure 2(a) is a side view of the drainage device 1, (b) is a side view of the drainage device 1 separated into its main components, and Figure 3 is a side cross-sectional view showing the configuration of the drainage device 1.

[0046] As shown in Figures 2(a)(b) and 3, the drainage device 1 has a configuration in which the puncture unit 15 is attached to the rotary introduction device 50 via a holder means 30.

[0047] The following describes the components of each unit that make up the drainage device 1.

[0048] (Puncture unit 15) The puncture unit 15 is the part that is inserted into the subject and is a disposable unit in the drainage device 1. The puncture unit 15 consists of an outer tube subunit 10 and an inner needle subunit 20 housed within the outer tube subunit 10.

[0049] The outer tube subunit 10 consists of a conduit 12, which is made up of a hollow needle at its tip that is used to puncture the subject, and a conduit base 11 connected to the proximal end of the conduit 12.

[0050] Figure 4 is a side cross-sectional view showing the configuration of the portion of the puncture unit 15 that is inserted into the body.

[0051] The conduit 12 can be a hollow metal needle having a cutting edge 12b at its tip (see Figures 3 and 4). For example, an 18-gauge needle (outer diameter φ1.26 mm, inner diameter φ0.90 mm (d12 in Figure 4)) may be used.

[0052] The conduit base 11 is made of a resin material and is a bottomed cylindrical housing member through which the lumen 12a of the conduit 12 and the internal space 11a are in communication. The opening at the base end is closed with a lid 111 to form a hollow bag-like closed shape, and the suction tube 61 is connected to the exhaust pipe 13 that is led out from the circumferential surface of the conduit base 11. For example, resin materials such as polyethylene, polypropylene, polyethylene terephthalate, polybutylene terephthalate, polyethylene naphthalate, polyamide, polyimide, and polyacetal can be used for the housing member of the conduit base 11. The suction tube 61 is connected to a suction device 60 such as a suction system or suction bottle in an operating room.

[0053] The internal needle subunit 20 consists of a screw needle 22 that extends into the conduit 12 in a state that allows it to rotate around the tube axis Ax, and a driving force acquisition means 21 connected to the base end of the screw needle 22. The driving force acquisition means 21 is a torque transmission means that acquires the driving force to rotate the screw needle 22 from the rotary introduction device 50 and transmits it to the screw needle 22.

[0054] The screw needle 22 is composed of multiple twisted wires formed by twisting together multiple core wires at a predetermined pitch. For example, as shown in Figure 4, the screw needle 22 is constructed using a twisted pair cable in which a pair of identical core wires 221 and 222 are twisted together at a predetermined pitch p. In this example, stainless steel wires with a diameter of 0.28 mm are used for the core wires 221 and 222, and the pitch of the single wires is set to 4 to 6 mm. By twisting them together in an Archimedean spiral shape, a twisted pair is formed with a pitch p of 2 to 3 mm and a maximum outer diameter (d22 in Figure 4) of φ0.56 mm. The twisted pair is then heat-treated to complete the screw needle 22. As a heat treatment, for example, by heating with a gas burner until red-hot and then rapidly cooling with water, a hardened steel screw needle 22 with high hardness and elasticity can be formed.

[0055] The driving force acquisition means 21 takes the form of a magnetic material 212 being inserted through a through hole 211a on the circumferential surface of a cylindrical, dense rotor housing member 211 connected to the base end of the screw needle 22, and is configured to rotate around the tube axis Ax in the internal space of the conduit base 11. The rotor housing member 211 can be made of the same resin material as the housing member of the conduit base 11. The driving force acquisition means 21 forms a magnetic coupling by magnetically coupling with the driving force supply means 40 in the rotary introduction device 50, which will be described later, and rotates in accordance with the driving rotation of the driving force supply means 40. Details of the configuration of the driving force acquisition means 21 will be described later. Note that the driving force acquisition means 21 may be constructed using an iron piece instead of the magnetic material 212.

[0056] As shown in Figure 2(b), the conduit base 11 of the outer tube subunit 10 has a lid 111 on its base end side. With the lid 111 open, the inner needle subunit 20 is inserted from the base end side of the conduit base 11, starting from the tip 22a of the screw needle 22, and the lid 111 is closed from the base end 211b side of the rotor housing member 211, sealing the internal space 11a of the conduit base 11 to form the puncture unit 15.

[0057] In the formed puncture unit 15, as shown in Figure 4, the screw needle 22 is positioned relative to the conduit 12 such that a portion of the tip 22a of the screw needle 22 is exposed from the opening of the blade surface 12b at the tip of the conduit 12.

[0058] Specifically, the cutting surface 12b at the tip of the conduit 12 is inclined at a predetermined angle with respect to the pipe axis Ax, and the tip 22a of the screw needle 22 is located within the range of the cutting surface 12b in the direction of the pipe axis Ax, that is, in the range from the tip 12b1 to the rear end 12b2 of the cutting surface 12b.

[0059] With this configuration, during the puncture process, the tip 12b1 of the blade surface 12b of the conduit 12 can efficiently puncture the subject's tissue. In addition, during the drainage process, semi-solid contents of the body, such as fat and highly viscous fluids, can be finely crushed by the tip 22a of the screw needle 22 and taken into the lumen 12a of the conduit 12, and efficiently transferred to the proximal end as the screw needle 22 rotates.

[0060] In the drainage device 1, the puncture unit 15, which has the above configuration, is connected to the rotary guide 50 with the holder means 30 in between, and the screw needle 22 of the puncture unit 15 is configured to be rotationally driven by the rotary guide 50.

[0061] (Holder means 30) The holder means 30 is a mechanical member interposed between the puncture unit 15 and the rotary feeder 50. When the puncture unit 15 is mounted on the rotary feeder 50, the holder means 30 has the function of positioning the conduit base 11 at a predetermined position on the rotary feeder 50 by fitting the conduit base 11 into the flange portion 32 protruding from the body portion 31, and preventing the conduit base 11 from rotating together with the screw needle 22 by holding the conduit base 11 in the circumferential direction with the notch 32a of the flange portion 32.

[0062] (Rotating introduction device 50) The rotary introduction device 50 is a main unit that generates a driving force to rotate the screw needle 22 and transmits it to the driving force acquisition means 21 of the puncture unit 15.

[0063] As shown in Figure 3, the rotary introduction device 50 comprises a housing 51 that constitutes the exterior, a motor 52, a drive circuit 53, a battery 54 housed inside the housing 51, and a drive force supply means 40 connected to the output shaft 521 of the motor 52. Furthermore, it may be equipped with a switch 55 that can be operated by the operator to independently switch between rotating / stopping the motor 52 and applying / releasing negative pressure by the suction device 60.

[0064] The housing 51 is configured to allow the puncture unit 15 to be attached in a detachable manner via a holder means 30, which will be described later.

[0065] The motor 52 can be a DC motor or a brushless DC motor that generates rotational driving force to rotate the screw needle 22. The battery 54 can be, for example, an alkaline dry cell battery, a nickel-metal hydride rechargeable battery, or a lithium-ion rechargeable battery. The drive circuit 53 is an electrical circuit that receives power from the battery 54 and drives the motor 52 to rotate at a predetermined set rotational speed, and the rotational speed of the motor 52 can be set in multiple stages by operating the operator's switch 55. For example, the rotational speed of the motor 52 may be 2000 to 10000 rpm (rotations per minute).

[0066] The driving force supply means 40 is a power transmission means that transmits the rotational force of the motor 52 to the driving force acquisition means 21. The driving force supply means 40 consists of a bottomed cylindrical coupling member 41 that is coaxially connected to the output shaft 521 of the motor 52, and a pair of magnets 42 embedded in two opposing openings 41b made in the opposing wall surfaces of the inner circumferential surface 41a of the coupling member 41. In this example, neodymium magnets were used for the magnets 42.

[0067] Figure 5 is an enlarged cross-sectional view showing details of the connection between the puncture unit 15 and the drive force supply means 40, where (a) shows the separated state and (b) shows the connected state. Figure 6 is a schematic diagram illustrating the operation of transmitting drive force from the drive force supply means 40 to the drive force acquisition means 21.

[0068] As shown in Figures 5(a) and 5(b), the puncture unit 15 is configured to be detachably attached to the housing 51 by inserting the conduit base 11 into the flange portion 32 of the holder means 30 from the base end 111a side of the lid portion 111. When the puncture unit 15 is attached to the rotary introduction device 50, as shown in Figure 5(b), the inner circumferential surface 41a of the coupling member 41 of the driving force supply means 40 faces the outer circumferential surface of the rotor housing member 211 of the driving force acquisition means 21 and the outer casing of the conduit base 11 at a predetermined distance apart. Then, as shown in Figure 6, a pair of magnets 42 provided on the inner circumferential surface 41a of the coupling member 41 and a magnetic material 212 provided on the rotor housing member 211 are magnetically coupled to form a magnetic coupling. As a result, the driving force supply means 40 transmits rotational force to the driving force acquisition means 21 without contact, and the driving force acquisition means 21 rotates in a driven manner.

[0069] The internal space 11a of the conduit base 11 where the driving force acquisition means 21 is located is in communication with the lumen 12a of the conduit 12. Therefore, during drainage, the driving force acquisition means 21 may come into contact with the transferred stored fluid. As shown in Figures 5(a) and 5(b), an isolator 11b that also serves as a bearing for the base end 22b of the screw needle 22 may be provided in the internal space 11a of the conduit base 11. In this case as well, since the base end 22b of the screw needle 22 penetrates the isolator 11b, it is difficult to reliably prevent contact between the rotor housing member 211 and the stored fluid.

[0070] However, as described above, the driving force supply means 40 can transmit rotational force to the driving force acquisition means 21 without contact, with the outer casing of the conduit base 11 sandwiched by the magnetic coupling. Therefore, the driving force can be transmitted from the driving force supply means 40 to the driving force acquisition means 21 without causing leakage of the stored liquid from the conduit base 11. (Positioning of the tip of the screw needle 22) In the puncture unit 15, the inner needle subunit 20 is attached to the outer tube subunit 10 with some play in the direction of the tube axis Ax. Therefore, when performing a puncture on a subject, the tip 22a of the screw needle 22 sinks into the opening 12b at the tip of the conduit 12, and the operator can efficiently perform the puncture by cutting through the subject's tissue with the blade surface 12b of the conduit 12.

[0071] However, when the puncture unit 15 is mounted on the rotary guide 50, the position of the diametrical axis of the magnetic body 212 provided on the rotor housing member 211 is attracted to the magnetic field lines MF of the pair of magnets 42 provided on the inner circumferential surface 41a of the coupling member 41, and coincides with the position in the direction of the tube axis Ax. In the drainage device 1, in this state, the screw needle 22 is configured to be positioned relative to the conduit 12 such that a portion of the tip 22a of the screw needle 22 is exposed from the opening 12b at the tip of the conduit 12.

[0072] Therefore, after the puncture is completed, when the puncture unit 15 is attached to the rotary guide 50, the axis of the magnetic body 212 moves to the position of the magnetic field line MF created by the magnet 42, and a portion of the tip 22a of the screw needle 22 is exposed from the opening 12b at the tip of the conduit 12. In this state, by driving the rotary guide 50, the highly viscous fluid accumulated in the body can be finely crushed by the tip 22a of the screw needle 22 during the drainage process and efficiently taken into the lumen 12a of the conduit 12.

[0073] (Regarding assembly between units) Next, we will describe the configuration in which each component unit of the drainage device 1 is connected to one another.

[0074] Figure 7(a) is a plan view showing the medical drainage device 1 separated into a puncture unit 15, a holder means 30, and a rotary introduction device 50, and (b) is a side view. A driving force supply means 40 is attached to the tip side of the rotary introduction device 50.

[0075] Figure 8(a) is a plan view of the medical drainage device 1 showing the proximal end of the puncture unit 15 inserted into the tip of the holder means 30, and (b) is a side view.

[0076] At this time, the conduit base 11 of the puncture unit 15 fits into the flange portion 32 of the holder means 30, and the conduit base 11 is held in the circumferential direction by the notch 32a of the flange portion 32. As a result, the position of the conduit base 11 of the puncture unit 15 is restricted with respect to the holder means 30, and the rotation of the conduit base 11 is restricted by the holder means 30, preventing it from rotating together with the screw needle 22 during operation.

[0077] Figure 9(a) is a plan view of the medical drainage device 1 showing the state in which the driving force supply means 40 of the rotary introduction device 50 is inserted into the base end of the holder means 30 to which the puncture unit 15 is attached and positioned relative to the driving force acquisition means 21, and (b) is a side view.

[0078] In this state, the drive force supply means 40 transmits rotational force to the drive force acquisition means 21 without contact, and by rotating the motor 52 of the rotary introduction device 50, the drive force acquisition means 21 is driven to rotate, thereby driving the screw needle 22 to rotate.

[0079] <About the operation of drainage device 1> Next, the operation of the drainage device 1 will be described. Figures 10(a) to (c) are side cross-sectional views illustrating the drainage operation by the drainage device 1.

[0080] Figure 10(a) shows the drainage device 1, consisting of a puncture unit 15, a holder means 30, and a rotary introduction device 50, combined as shown in Figures 9(a) and (b). A puncture is performed using the puncture unit 15, a suction tube 61 is connected to the puncture unit 15, and negative pressure P1 is applied to the surgical site by the suction device 60. In this state, the fluid L1 in the body is in a semi-solid state, consisting of fat and highly viscous fluids. The fluid L1 adheres to the cutting surface 12b of the conduit 12 due to the negative pressure P1, but does not enter the inside of the opening.

[0081] Next, as shown in Figure 10(b), when the motor 52 of the rotary inlet 50 is driven to rotate the drive force supply means 40 while a negative pressure P1 is applied by the suction device 60 (R1), the drive force acquisition means 21 rotates in a driven manner by the magnetic coupling (R2), and the screw needle 22 extending into the lumen 12a of the conduit 12 rotates (R3).

[0082] In this case, as described above, in the drainage device 1, the screw needle 22 is positioned relative to the conduit 12 such that a portion of the tip 22a of the screw needle 22 is exposed from the opening of the cutting surface 12b of the conduit 12. Therefore, the tip 22a of the screw needle 22 functions as a rotating drill, causing the fluid L1 in the body to be finely fragmented, and the fragmented fluid L2 can be taken into the lumen 12a of the conduit 12.

[0083] Furthermore, as shown in Figure 10(c), the stored liquid L2, which has been crushed by the rotation R3 of the screw needle 22, can be efficiently transferred to the base end side by the helical structure and negative pressure P1. The stored liquid L3 transferred to the internal space 11a of the conduit base 11 is then sucked in by the negative pressure P1 of the suction device 60 and transferred from the internal space 11a of the conduit base 11 through the exhaust pipe 13 to the drainage channel.

[0084] <Evaluation Test> The performance of the drainage device 1 according to the embodiment was evaluated through evaluation tests using examples and comparative examples. The results are described below.

[0085] (Examples) As an example of Drainage Device 1, a full-scale, usable prototype was created and evaluated.

[0086] An 18-gauge injection needle (outer diameter φ1.26 mm, inner diameter φ0.90 mm) was used for the conduit 12, and a 1.5 mL microtest tube was used for the base of the conduit 11.

[0087] The screw needle 22 was made using stainless steel wire, which was twisted together in an Archimedean spiral shape to form a twisted pair wire, and then heat-treated by heating and water cooling. Specifically, the screw needle 22 was made by twisting two 0.28 mm diameter stainless steel wires clockwise to form a twisted pair wire, and then heat-treating it to create a paper-twist-shaped metal part. The twist pitch of each stainless steel wire (single wire) was approximately 4-6 mm, and by combining and twisting the two wires together, a constriction in the spiral shape with a pitch p of approximately 2-3 mm after twisting was formed.

[0088] Furthermore, after forming the twisted wire pairs, the steel was heated with a gas burner until it glowed red, and then rapidly cooled with water to produce a hardened steel with high hardness and elasticity.

[0089] The tip end of the screw needle 22 has not undergone any special cross-sectional processing. The base end is connected to the rotor housing member 211 which contains the magnetic material 212.

[0090] The rotor housing member 211 of the driving force acquisition means 21 and the coupling member 41 of the driving force supply means 40 were manufactured from resin material using a 3D printer. Specifically, the rotor housing member 211 is a cylindrical resin (stereolithography resin) member with a magnetic material 212 fitted perpendicular to the axial direction Ax. A 0.5 mm hole was made in the axial direction Ax, and the cut end of the base end of the screw needle 22 was inserted and the cut end was bonded and fixed to the hole with epoxy resin. The rotor housing member 211 was installed in the internal space 11a of the conduit base 11, and it was confirmed that it rotated smoothly with the screw needle 22 as the shaft 22a and the conduit 12 as the bearing.

[0091] A modified commercially available cooking utensil was used for the rotary feeder 50, and the rotation speed of the screw needle 22 was set to 8000 rpm.

[0092] Furthermore, a neodymium magnet was used for the magnet 42 of the driving force supply means 40, and an iron piece was used for the magnetic material 212 of the driving force acquisition means 21.

[0093] Figure 11 is a photograph of the drainage device 1 according to the embodiment. Figure 12 is a photograph of the embodiment separated into units, where (a) is the puncture unit 15, (b) is the holder means 30, and (c) is the rotary introduction device 50 including the driving force supply means 40. Figures 13(a) and (b) are photographs of the embodiment separated into the outer tube subunit 10 (Figure 13(a)) and the inner needle subunit 20 (Figure 13(b)).

[0094] (Comparative example) As a comparative example, the drainage device 1 according to the embodiment was modified by removing the internal needle subunit 20, connecting a suction tube 61 to the puncture unit 15, and applying negative pressure P1 from the suction device 60 to the tip of the conduit 12 through the lumen 12a of the conduit 12.

[0095] (Test results) [Evaluation Test 1] First, a paste-like substance L, such as animal fats like miso, lard, and cottage cheese, which is more viscous and semi-solid than the substances actually collected in the body during surgery, was filled into a resin test tube CA. This was used as a model of the contents of an ovarian tumor (mature cystic teratoma of the ovary), and drainage tests were performed using the examples and comparative examples.

[0096] A vacuum pump set to the same pressure (-0.05 MPa) as the operating room suction device was used as the suction device.

[0097] Figures 14(a) to 14(c) are photographs showing the results of Drainage Evaluation Test 1 using an example of Medical Drainage Device 1 and Comparative Example 1X. Figure 14(a) shows the state before the start of the test, Figure 14(b) shows the state after 10 seconds, and Figure 14(b) shows the state after 20 seconds. Comparative Example 1X is shown on the left side of the photograph, and Example 1 is shown on the right side.

[0098] As shown in Figures 14(b) and 14(c), it was not possible to aspirate the paste-like substance L in Comparative Example 1X, but it was confirmed that in Example 1, it was possible to efficiently aspirate most of the paste-like substance L filled in the resin test tube CA.

[0099] [Evaluation Test 2] Next, with the paste substance L deposited on tray TL, drainage tests were performed using the examples and comparative examples under the same conditions.

[0100] Figure 15 is a photograph showing the configuration of a drainage test using tray TL. Figures 16(a) to (c) are photographs showing the results of another drainage test using drainage device 1 and comparative example 1X.

[0101] Figures 16(a) to 16(c) are photographs showing the results of drainage evaluation test 2 using an example of medical drainage device 1 and comparative example 1X. Figure 16(a) shows the state before the start of the test, Figure 16(b) shows the state after 10 seconds, and Figure 16(b) shows the state after 13 seconds. Comparative example 1X is shown on the left side of the photograph, and example 1 is shown on the right side.

[0102] As shown in Figures 16(b) and 16(c), it was impossible to aspirate the paste-like substance L in Comparative Example 1X. In contrast, it was confirmed that the paste-like substance L deposited on the tray TL could be efficiently aspirated and removed in Example 1. In Figures 16(b) and 16(c), it can be seen that in Example 1, a portion of the paste-like substance L was aspirated and removed, exposing the surface of the tray TL.

[0103] (effect) Evaluation tests 1 and 2 confirmed the following effects.

[0104] In model experiments using substances with higher viscosity and a semi-solid state than those found in actual surgical situations, such as miso, lard, and cottage cheese, the suction tube was more efficient than conventional suction tubes, and the contents were aspirated without the circuit becoming blocked along the way.

[0105] Based on the above results, 1) to 3) were confirmed.

[0106] A puncture unit 15 was created using an 18-gauge puncture needle with a rotating screw needle 22 inside as the conduit 12. The screw needle 22 has a spiral shape and is slightly exposed from the cutting surface 12b at the tip of the needle in the conduit 12. By rotating it at high speed, the following effects can be obtained. 1) The high-viscosity reservoir fluid, attracted to the cutting surface 12b at the tip of the conduit 12 by the negative pressure P1, is scraped by the exposed spiral tip of the screw needle 22. 2) As the spiral shape of the screw needle 22 rotates, the crushed stored liquid is transported through the lumen 12a of the conduit 12 toward the internal space 11a of the conduit base 11 at the proximal end (acting as a pump by the Archimedean screw mechanism). 3) The stored liquid, fragmented by the negative pressure P1, is sucked out from the internal space 11a of the conduit base 11 and drained into an external tank or the like.

[0107] This series of processes can be performed simultaneously, continuously, and automatically.

[0108] Furthermore, with the drainage device 1, after the puncture into the subject is completed, a rotary guide 50 containing a DC motor or brushless motor 52 is connected, thereby obtaining the driving force for the screw needle 22 from a rotating magnetic field installed outside the conduit base 11, and the magnetic body 212 connected to the screw needle 22 can be rotated non-contact by magnetic coupling. This magnetic coupling mechanism makes it possible to miniaturize and reduce the cost of the puncture unit 15.

[0109] <Summary> As described above, the puncture unit 15 according to the embodiment is characterized by comprising: a conduit 12 whose tip is capable of puncturing a subject and to which a suction device 60 can be connected so as to communicate with the lumen 12a behind the proximal end; a screw needle 22 extending in the direction of the tube axis Ax from the tip opening of the conduit 12 to at least the proximal end of the conduit 12, in a state in which it can rotate around the tube axis Ax in the lumen 12a of the conduit 12; and a driving force acquisition means 21 located behind the proximal end of the conduit 12 and connected to the proximal end 22b of the screw needle, which acquires the driving force to rotate the screw needle 22.

[0110] Furthermore, the fluid accumulated in the body is crushed by the rotation of the screw needle 22 and taken into the conduit 12 through the tip opening of the conduit 12, and is transported at least to the proximal end of the conduit 12 as the screw needle 22 rotates, and is then suctioned and transported by the negative pressure of the suction device 60.

[0111] With this configuration, the puncture unit 15 can be realized with a simple and inexpensive device configuration, and with a minimally invasive configuration in which the outer diameter of the conduit 12 is, for example, that of a 1.8 gauge injection needle, enabling efficient aspiration and removal of highly viscous fluid accumulated in the body in a short time.

[0112] As a result, it becomes possible to further minimize invasive medical procedures for percutaneous or transvaginal drainage of viscous fluid accumulations that require drainage, such as percutaneous or transvaginal abscess drainage for indicated conditions like intra-abdominal abscesses, empyema or subcutaneous abscesses; percutaneous or transvaginal drainage for accumulation of intra-abdominal bleeding; percutaneous burr hole drainage for intracranial hematomas; transvaginal drainage for ovarian cysts or ovarian hematomas; CT-guided drainage or transvaginal drainage for retroperitoneal abscesses or cesarean section wound abscesses.

[0113] Alternatively, the device may be configured to include a hollow bag-shaped conduit base 11 connected to the base end of the conduit 12, with the inner lumen 12a of the conduit 12 communicating with the internal space 11a, and an exhaust pipe 13 extending from the outer shell connected to a suction device 60. The driving force acquisition means 21 is positioned in the internal space 11a of the conduit base 11 in a state where it can rotate around the tube axis Ax of the conduit 12, and non-contactively receives the driving force supplied from outside the conduit base 11a, transmitting the driving force to the screw needle 22. The stored liquid in the body is transferred to the internal space 11a of the conduit base 11 as the screw needle 22 rotates, and is then sucked out by the suction device 60 and transferred to the outside of the internal space 11a.

[0114] With this configuration, the tip 22a of the screw needle 22 functions as a rotating drill, finely crushing the stored fluid in the body. The crushed stored fluid is then drawn into the lumen 12a of the conduit 12 and efficiently transferred to the proximal end by the spiral structure of the screw needle 22 and the negative pressure P1. Furthermore, the stored fluid L3 transferred to the internal space 11a of the conduit base 11 is sucked in by the negative pressure P1 of the suction device 60 and discharged from the internal space 11a of the conduit base 11 through the exhaust pipe 13.

[0115] Furthermore, the medical drainage device 1 according to the embodiment comprises the puncture unit 15 described above and a rotary introduction device 50, the rotary introduction device 50 having a housing 51 to which the puncture unit 15 can be detachably attached, a motor 52 that generates rotational driving force and is located in the housing 51, and a driving force supply means 40 connected to the output shaft 521 of the motor 52, which faces the driving force acquisition means 21 and the outer casing of the conduit base 11 when the puncture unit 15 is attached to the housing 51, and the driving force supplied from the driving force supply means 40 may be transmitted to the driving force acquisition means 21 non-contact via the outer casing of the conduit base 11.

[0116] With this configuration, a medical drainage device 1 can be realized that efficiently aspirates and removes highly viscous fluid accumulated in the body in a short time using a simple and inexpensive device configuration and a minimally invasive method in which the conduit 12 is used as an injection needle.

[0117] Alternatively, the driving force supply means 40 and the driving force acquisition means 21 may be configured as a magnetic coupling, magnetically coupled by opposing magnets 42 and magnetic material 212, respectively, so that the driving force acquisition means 21 is driven by the driving rotation of the driving force supply means 40.

[0118] With this configuration, the driving force supply means 40 can transmit rotational force to the driving force acquisition means 21 without contact, while the outer casing of the conduit base 11 is sandwiched by a magnetic coupling. Therefore, the driving force can be transmitted from the driving force supply means 40 to the driving force acquisition means 21 to perform drainage without causing leakage of stored liquid from the conduit base 11.

[0119] ≪Variations≫ The specific configuration of this disclosure has been described above using embodiments as examples. However, this disclosure is not limited in any way to the embodiments described above, except for its essential characteristic components. For example, forms obtained by applying various modifications to the embodiments, and forms realized by arbitrarily combining the components and functions of each embodiment without departing from the spirit of the present invention are also included in this disclosure.

[0120] Below, we will describe a variation as an example of such a form. (1) In the above embodiment, the drainage device 1 was shown using ovarian cystectomy as an example. However, the use of the suction device according to the present invention is not limited to percutaneous puncture drainage for intracranial hematoma, but can be widely used in surgeries that involve fluid accumulation in the lesion or surgical field, such as ovarian cysts, peritonitis, and intra-abdominal hemorrhage, and require the suction and removal of the accumulated fluid from the body.

[0121] Specifically, this method can be used to minimize invasiveness in procedures involving percutaneous or transvaginal drainage for indications such as intra-abdominal abscesses, empyema, or subcutaneous abscesses; percutaneous or transvaginal drainage for intra-abdominal bleeding; percutaneous burr hole drainage for intracranial hematomas; transvaginal drainage for ovarian cysts or hematomas; CT-guided drainage or transvaginal drainage for retroperitoneal abscesses or cesarean section wound abscesses; and other percutaneous or transvaginal drainage procedures for indications involving the accumulation of viscous fluid that requires drainage. (2) In the above embodiment, the puncture unit 15 was shown using an example configuration in which an 18-gauge injection needle consisting of a straight, hollow metal needle was used for the conduit 12. However, the material, length, and diameter of the conduit 12 and screw needle 22 are not limited to those described above and may be appropriately changed depending on the target disease.

[0122] Figure 17 is a side cross-sectional view showing the configuration of a puncture unit 15A used in a modified medical drainage device.

[0123] The puncture unit 15A differs from the puncture unit 15 in that the conduit 12A is constructed using a flexible needle, such as polyvinyl chloride. The conduit 12A is composed of a tip region Tr including the tip, a rear end region Rr including the rear end, and an intermediate region Mr between the tip region Tr and the rear end region Rr. At least the intermediate region Mr of the conduit 12A is made of a soft wire material that has lower hardness and flexibility than the material of the conduit 12 in the embodiment. As a flexible material, hollow tubes made of polyvinyl chloride or similar material may be used.

[0124] Furthermore, the screw needle 22 may be constructed using a resin material that can achieve both low friction with respect to the conduit 12A and flexibility, such as nylon or perfluoroelastomer (FFKM).

[0125] Other components of the puncture unit 15A can be the same as those used in the puncture unit 15.

[0126] The puncture unit 15A secures an access route within the blood vessel by percutaneously inserting a rigid puncture needle PN made of metal or the like into the blood vessel and leaving it there. The conduit portion 12A of the puncture unit 15A is inserted into the lumen of the puncture needle PN, and the tip region Tr of the conduit 12A is brought to the target site such as a hematoma to perform drainage. The length of the intermediate region Mr of the conduit 12A may be appropriately changed depending on the distance from the percutaneous surface to the target site.

[0127] The puncture unit 15A allows for the creation of a puncture unit that facilitates the procedure using a rigid tube 12A1, while minimizing the risk of damaging the lungs or pelvic organs using a flexible tube 12A2.

[0128] Furthermore, the puncture unit 15A can be used to remove intravascular thrombi by inserting a puncture unit with a flexible tube into a blood vessel. For example, it can be used in transcatheter pulmonary thrombolysis for pulmonary embolism. (3) In the above embodiment, the screw needle 22 of the puncture unit 15 is made up of multiple strands of core wires twisted together at a predetermined pitch, and the embodiment shows an example in which a pair of identical core wires 221 and 222 are twisted together at a predetermined pitch p to form a twisted pair. However, the configuration and manufacturing method of the screw needle 22 are not limited to the above and may be changed as appropriate.

[0129] The modified screw needle 22 may be formed, for example, from resin or metal material using a 3D printer. Alternatively, it may be constructed using main and secondary wires of different thicknesses, with the thinner secondary wire spirally wound around the thicker main wire.

[0130] This makes it possible to create a structure that is easy to manufacture and can efficiently transfer high-viscosity liquids to the proximal end.

[0131] ≪Additional Information≫ The embodiments described above all represent preferred specific examples of the present invention. The numerical values, shapes, materials, components, arrangement and connection configurations of components, processes, and order of processes shown in the embodiments are examples only and are not intended to limit the present invention. Furthermore, components in the embodiments that are not described in the independent claims representing the highest-level concept of the present invention are described as any components that constitute a more preferred form.

[0132] Furthermore, the order in which the above methods are performed is illustrative for the purpose of specifically illustrating the present invention, and may be performed in a different order. Also, some of the above methods may be performed simultaneously (in parallel) with other methods.

[0133] Furthermore, for the sake of easier understanding of the invention, the scale of the components shown in the figures of each embodiment described above may differ from that of the actual components. Moreover, the present invention is not limited by the descriptions of each embodiment described above, and can be modified as appropriate without departing from the spirit of the invention.

[0134] Furthermore, at least some of the functions of each embodiment and its modified form may be combined. [Industrial applicability]

[0135] A puncture unit and a medical drainage device according to one aspect of this disclosure can be widely used as a means of aspirating and removing fluid accumulated in lesions or surgical fields. [Explanation of Symbols]

[0136] 1. Medical drainage device 15 Puncture Units 10 Outer Tube Subunit 11 Conduit base 111 Lid 12 Conduit 13 Exhaust pipe 20 Inner needle subunit 21 Means for obtaining driving force 211 Rotor housing component 212 Magnetic material 22 Screw Needle 221, 222 core wires 30 Holder means 31 Torso 32 Flange section 50-speed induction device 40 Driving force supply means 41 Coupling member 42 Magnets 51 cabinets 52 Motors 521 Output shaft 53 Drive Circuit 54 batteries 55 switches 60 Suction device 61 Suction tube

Claims

1. A puncture unit for transferring fluids accumulated throughout the body to the outside, A conduit having at least its tip capable of puncturing a subject, and configured to allow connection of a suction device to the tubular lumen at the posterior end, Within the lumen of the conduit, a screw needle extends in the axial direction from the tip opening of the conduit to at least the base end of the conduit, in a state that allows it to rotate around the tube axis, A driving force acquisition means located behind the base end of the conduit and connected to the base end of the screw needle, which acquires the driving force to rotate the screw needle, It is connected to the base end of the aforementioned conduit, and the internal space is in communication with the lumen of the conduit, and it has a hollow bag-shaped conduit base, The driving force acquisition means receives the driving force supplied from outside the conduit base non-contact through the outer casing of the conduit base and transmits the driving force to the screw needle. Puncture unit.

2. The fluid accumulated in the body is crushed by the rotation of the screw needle and taken into the conduit through the tip opening of the conduit, and is transported at least to the proximal end of the conduit as the screw needle rotates, and is then suctioned and transported by the negative pressure of the suction device. The puncture unit according to claim 1.

3. The conduit base is configured such that an exhaust pipe extending from the outer shell can be connected to the suction device, The driving force acquisition means is arranged in the internal space of the base of the conduit so as to be rotatable around the tube axis of the conduit, The fluid stored in the body is transferred to the internal space at the base of the conduit as the screw needle rotates, and is then sucked out of the internal space by the suction device. The puncture unit according to claim 1.

4. A portion of the tip of the screw needle is exposed through the opening at the tip of the conduit. The puncture unit according to claim 1.

5. The cutting surface at the tip of the conduit is inclined with respect to the axis, and the tip of the screw needle is within the range of the cutting surface in the direction of the tube axis. The puncture unit according to claim 4.

6. The aforementioned screw needle consists of multiple strands of core wires twisted together at a predetermined pitch. The puncture unit according to claim 1.

7. The aforementioned conduit consists of an injection needle. The puncture unit according to claim 1.

8. The conduit consists of a rigid tube in the tip region including the front end and the rear end region including the rear end, and a flexible tube made of a material with lower hardness and flexibility than the rigid tube in the intermediate region between the tip region and the rear end region. The puncture unit according to claim 1.

9. A puncture unit according to claim 1, and a rotary introduction device, The aforementioned rotary introduction device is The housing on which the aforementioned puncture unit can be detachably attached, A motor that generates rotational driving force is arranged in the aforementioned housing, When the puncture unit is mounted on the housing, it has a drive force acquisition means and a drive force supply means connected to the output shaft of the motor, which are opposite each other across the outer casing of the conduit base, The driving force supplied from the driving force supply means is transmitted non-contact to the driving force acquisition means via the outer casing of the conduit base. Medical drainage device.

10. The driving force supply means and the driving force acquisition means constitute a magnetic coupling, which is magnetically connected by a pair of opposing magnets arranged in each, and the driving force acquisition means is driven by the driving rotation of the driving force supply means. A medical drainage device according to claim 9.

11. The puncture unit is mounted on the rotary introduction device, The screw needle is positioned in the axial direction of the conduit such that a portion of the tip of the screw needle is exposed from the opening at the end of the conduit. A medical drainage device according to claim 9.

12. A holder means is provided between the puncture unit and the rotary introduction device. When the puncture unit is mounted on the rotary guide, the conduit base is fitted into the holder means, thereby preventing the conduit base from rotating together with the screw needle. A medical drainage device according to claim 9.

13. The rotary introduction device has a switch that can be operated by the operator, allowing independent switching of the motor's rotation / stop and the negative pressure applied / released by the suction device. A medical drainage device according to claim 9.

14. The fluid accumulation in the body is one of the following: intra-abdominal abscess, empyema, subcutaneous abscess, accumulation of intra-abdominal hemorrhage, intracranial hematoma, ovarian cyst, ovarian hematoma, retroperitoneal abscess, or cesarean section wound abscess. A medical drainage device according to claim 9.