WO2016208711A1 - Medical equipment guide device - Google Patents

Abstract

In the present invention, a medical equipment guide device is characterized by being provided with at least one retaining part for retaining and guiding medical equipment, a positioning means for determining the orientation of the retaining part, and at least one covering means, wherein the covering means covers the positioning means, and the medical equipment is disposed relative to the covered positioning means.

Description

Medical instrument guide device

The present invention relates to a medical instrument guide device for holding and positioning a medical instrument.

As a typical technique for minimally invasive treatment, percutaneous puncture treatment for guiding a needle to an affected area is widely performed. Puncture treatment includes ablation in which treatment is performed by burning tumors and cancer cells by radio waves, and cryotherapy in which the tumors and cancer cells are frozen by a freezer or cooling gas. On the other hand, biopsy by puncture is widely performed as part of pathological diagnosis based on tissue collection. In such puncture treatment, in order to accurately position the needle with respect to a target such as a tumor, a medical image captured by X-ray CT, MRI or the like is used as a means for visualizing the needle in the body. In the puncture treatment using the visualization means based on such a modality, it is difficult to position the target with respect to the target in one imaging and one puncturing process. In general, treatment is performed by reaching the target while correcting the puncture trajectory little by little. Therefore, in order to shorten the operation time and reduce the burden on the patient, development of a needle positioning device for positioning on the target with a small number of trajectory corrections is active. Patent Document 1 and Patent Document 2 relate to a Needle placement manipulator that performs needle positioning based on a biaxial RCM (Remote Center of Motion) mechanism. According to Patent Documents 1 and 2, first rotary guide, 3. By two positioning means of second rotary guide, 7. Means for determining the orientation of the needle are disclosed. Patent Documents 1 and 2 disclose that: first rotary guide, 3. 512 in the second rotary guide. actuator, 514. There is a disclosure about the Needle placement manipulator incorporating a sensor.

In Patent Documents 1 and 2, 6. 4. needle holder and 5. The base body is described as having to be sterilized because it may touch the doctor or the patient. There are various methods for sterilization, and sterilization methods by heating, electromagnetic waves, and chemical action are generally used. Among these sterilization methods, high temperature and high pressure steam sterilization methods using autoclaves, which have been introduced into a relatively large number of medical institutions and used for various medical instruments, are metal such as forceps and fibrous materials such as gauze. Suitable for medical devices. In this sterilization method, since sterilization is performed under a temperature condition of about 150 [° C.], electronic parts, those made of general-purpose plastics with low heat resistance, those containing adhesives that soften or deteriorate under high heat, etc. On the other hand, it is often difficult to sterilize without destruction or deterioration. On the other hand, hydrogen peroxide low temperature plasma sterilization, which is one of chemical sterilization methods that can be sterilized at relatively low temperatures (about 60 ° C), is made of electronic parts and general-purpose plastics with low heat resistance. There are cases in which sterilization is possible even for those that contain adhesives that soften or deteriorate under high heat, and the range of sterilizable objects is widened. However, this method requires the introduction of expensive equipment capable of low-temperature plasma sterilization with hydrogen peroxide. For example, sterilization of a device having a minute gap of 0.5 [mm] or less or a fibrous material is guaranteed. There are also disadvantages such as not.

NEEDLE PLACEMENT MANIPULATOR WITH ATTACHMENT FOR RF-COIL US2014 / 0275978 NEEDLE PLACEMENT MANIPULATOR WITH TWO ROTARY GUIDES US 2014/0275979

In Patent Documents 1 and 2, the need for sterilization is recognized for needle holder 6 and base body 5. However, in fact, it is necessary to sterilize parts other than needle holder 6 and base body 5, so that these parts are either directly sterilized or non-sterile parts do not touch doctors and patients directly. There is a need to incorporate a complicated process such as sterilization sheet (Drape) or covering with a plastic bag into a part of a surgical procedure (workflow).

On the other hand, even if an attempt is made to sterilize the entire device, for example, the two positioning means of first rotary guide 2 and second rotary guide 3 are equipped with electronic devices that are difficult to sterilize, so it may be difficult to sterilize. It is done. In such a case where sterilization is difficult, there is a problem that an expensive sterilization method must be taken if an electronic device is directly sterilized.

In view of the above, there is a demand for a mechanism that can sterilize more easily when electronic components are difficult to sterilize for reasons of characteristics and reliability.

In the following description, a holding unit that holds and guides at least one medical device, a positioning unit that determines an orientation of the holding unit, and at least one coating unit, the coating unit covers the positioning unit. The medical instrument guide device is characterized in that the medical instrument is disposed with respect to the covered positioning means.

According to the present invention, it is possible to provide a mechanism that can sterilize electronic components and the like more easily.

Other features and advantages of the present invention will become apparent from the following description with reference to the accompanying drawings. In the accompanying drawings, the same or similar components are denoted by the same reference numerals.

The accompanying drawings are included in the specification, constitute a part thereof, show an embodiment of the present invention, and are used to explain the principle of the present invention together with the description.
The schematic perspective view of the medical instrument guide apparatus 1 in 1st Embodiment is shown. The schematic sectional drawing of the medical instrument guide apparatus 1 in 1st Embodiment is shown. (B) The enlarged view of the broken-line area | region B of the medical instrument guide apparatus 1 in 1st Embodiment, (c) The enlarged view of the broken-line area | region C of the medical instrument guide apparatus 1 is shown. The schematic sectional drawing of the medical instrument guide apparatus 1 in 1st Embodiment is shown. (A) Schematic sectional view of first positioning means, (b) Schematic sectional view of second positioning means. The surgical procedure (workflow) in 1st Embodiment is shown. The schematic perspective view of the medical instrument guide apparatus 101 in 2nd Embodiment is shown. The schematic expanded view of the 4th coating | coated means 122 of the medical instrument guide apparatus 101 in 2nd Embodiment is shown. The schematic sectional drawing of the medical instrument guide apparatus 101 in 2nd Embodiment is shown. The schematic sectional drawing of the medical instrument guide apparatus 101 in 2nd Embodiment is shown. The surgical procedure (workflow) in 2nd Embodiment is shown. The schematic perspective view of the medical instrument guide apparatus 201 in 3rd Embodiment is shown. The schematic sectional drawing of the medical instrument guide apparatus 201 in 3rd Embodiment is shown. The schematic perspective view of the 5th coating | coated means 224 in 3rd Embodiment is shown. The surgical procedure (workflow) in 3rd Embodiment is shown. The schematic perspective view of the 3rd coating | coated means 310 in 4th Embodiment is shown. The schematic sectional drawing of the medical instrument guide apparatus 301 in 4th Embodiment is shown. The schematic perspective view of the 2nd coating | coated means 404 in 5th Embodiment is shown. The schematic sectional drawing of the 2nd coating | coated means 404 in 5th Embodiment is shown. The schematic sectional drawing of the medical instrument guide apparatus 401 in 5th Embodiment is shown. The schematic perspective view of the medical instrument guide apparatus 501 in 6th Embodiment is shown. The schematic sectional drawing of the medical instrument guide apparatus 501 in 6th Embodiment is shown. The enlarged view of the broken-line area | region E of the schematic sectional drawing of the medical instrument guide apparatus 501 in 6th Embodiment is shown.

Hereinafter, through the first to sixth embodiments of the present invention, a holding unit that holds and guides at least one medical device, a positioning unit that determines an orientation of the holding unit, and at least one covering unit are provided, A medical instrument guide device in which the covering means covers the positioning and the medical instrument is arranged with respect to the coated positioning means will be described below. Here, new embodiments derived from combinations of the embodiments are also within the scope of the present invention.

(First embodiment)
1st Embodiment is described using FIG. 1 thru | or FIG. The coordinate system used for each figure is the same. FIG. 1 is a schematic perspective view of a medical instrument guide apparatus 1 according to the first embodiment. FIG. 2A is a schematic cross-sectional view of the medical instrument guide apparatus cut along a plane parallel to the zx plane passing through the center of the medical instrument 2. FIG. 3 shows a state where the medical instrument guide device 1 shown in FIG. 2 is mounted on the abdomen 13 of a human body, and shows a state of a minimally invasive puncture operation in a simulated manner.

The medical instrument guide apparatus in the present embodiment is an RCM (Remote Center of Motion) mechanism having two degrees of freedom of rotation, and details thereof will be described. In this embodiment, the nuclear magnetic resonance imaging apparatus MRI is used as a means for visualizing the inside of the body, a medical instrument, a medical instrument guide apparatus, and the like, but is not limited thereto.

First, the structure of the medical instrument guide device 1 will be described using reference numerals. In FIG. 3, a sterilized sheet 15 having a hole is covered on a human body 13, and the medical instrument guide device 1 is installed thereon. In the medical instrument guide device 1, a hollow RF coil 5 having an opening is placed on the second covering means 4.

As shown in FIG. 3, the RF coil 5 is wrapped with a sterilization sheet 16. As shown in FIG. 2A, a base 6 having an opening 6a is installed on the second covering means 4 having the opening 4a. In addition, in this description, when the wording of an opening part is used, it shall point out what is called an opening and the site | part of the inner wall of a ring shape or a cylindrical shape. A first positioning means 7 having a first opening 7a is attached on the base 6, and a first covering means 8 is attached on the first positioning means 7, and the first positioning means 7 is located outside the opening 8 a of the first covering means 8. Here, the outside of the opening 8a refers to the outside of the surface of the inner wall of the first covering means. The first positioning means 7 is a rotary positioning means capable of causing a relative displacement in the rotational direction between the base 6 and the first covering means 8 around the LL ′ axis in FIG. It is. A second positioning means 9 is attached to the first covering means 8.

Further, in FIG. 2A, a third covering means 10 having an opening 10 a is attached to the upper end portion of the second positioning means 9. A holder 3 for holding and guiding the medical instrument 2 is attached to the third covering means 10, and an ablation needle for puncture surgery is attached as the medical instrument 2 in the present embodiment.

The medical instrument 2 is disposed inside the openings 10a, 8a and 4a. In this case, the holding unit 3 restrains the degree of freedom in the longitudinal direction of the medical instrument 2 and four degrees of freedom other than the degree of freedom of rotation with the longitudinal direction as the rotation axis, and slides the medical instrument 2 in the longitudinal direction of the medical instrument 2. Thus, the medical device 2 can be held and guided.

The second positioning means 9 may cause a relative displacement in the rotational direction between the first covering means 8 and the second covering means 4 around the UU ′ axis as shown in FIG. Possible rotary positioning means. The UU ′ axis and the LL ′ axis are designed to form an angle θ. The angle θ is set so as to satisfy the condition of 0 ° <θ <90 °. For example, it is desirable to set θ = 15 ° to 20 °. Returning to the description of FIG. 2A, the base 6 is provided with a connector 12 for supplying power and acquiring signals to the first and second positioning means 7 and 9. The first covering means 8 incorporates an electric substrate 11 used for supplying power to the first and second positioning means and relaying signal acquisition.

FIGS. 2B and 2C are enlarged views of regions B and C surrounded by a broken line in FIG. 2A, respectively. According to FIG. 2 (b), the first covering means 8 and a part of the third covering means 10 form a nested labyrinth structure 18, and the second positioning shown in FIG. 4 (b). The second opening 9 a of the means 9 is configured not to be exposed inside the opening 8 a of the first covering means 8. Further, a gap 19 is provided between the second positioning means 9 and the first covering means 8 and the third covering means 10, thereby constituting a mechanism in which the second positioning means 9 can rotate. . On the other hand, according to FIG. 2C, the first covering means 8 and the opening of the base 6 form a nested labyrinth structure 20, and the opening 6 a of the base 6 and the first positioning means 7. Is configured so as not to be exposed inside the first covering means 8. Further, the first covering means 8 has a gap 21 between the base 6 and the second covering means 4, thereby constituting a mechanism that is relatively movable with respect to the base 6 and the second covering means 4. ing. As described above, the first and second positioning means and the base 6 constitute a positioning device in which the first covering means 8 is not exposed.

Here, the material used for each part which comprises the medical instrument guide apparatus 1 is demonstrated. For the material forming the third covering means 10 and the holding part 3, it is desirable to apply engineering plastics such as polyetheretherketone (PEEK) in order to cope with sterilization under high temperature conditions. The base 6 corresponds to the wiring and electrical component mounting corresponding to the first and second positioning means, and is applied with an engineering plastic such as polyether ether ketone (PEEK) having high heat resistance in preparation for the risk of ignition of the electric system. Is desirable. Since the first covering means 8 also serves as a supporting structure material for the first and second positioning means, the first covering means 8 is formed of a transparent engineering plastic such as polycarbonate (PC) having a relatively high rigidity, for example. Is preferred. In forming the first covering means 8, the electric substrate 11 can be placed inside the first covering means by forming the electric substrate 11 by in-mold injection. Materials for forming the first and second positioning means will be described later.

Next, details of the first and second positioning means will be described with reference to FIG. FIGS. 4A and 4B are sectional views of the first and second positioning means, respectively. 4A and 4B, the positioning unit includes components of a piezoelectric actuator that is a driving source and an optical encoder that is an angular position detection unit in the rotation direction. However, the present invention is not limited to this, and the drive source may be installed outside or the position may be manually changed by the operator instead of the electrical drive source. In FIG. 4A, the first fixing portion 30 is positioned and fixed in the radial direction to the base 6 via the fitting portion 30a, and is positioned in the circumferential direction via engaging means (not shown). Although the base 6 is not shown in FIG. 4, as can be seen from FIG. 2C, the base 6 is disposed immediately below the first fixing portion 30. On the other hand, the first rotating portion 31 is connected to the first fixed portion 30 via the slide bearing 33 so as to be rotatable around the LL ′ axis in FIG. An electro-mechanical energy conversion element 36 is fixed to the elastic member 37 with an adhesive (not shown). The elastic member 37 and the electromechanical energy conversion element 36 are pressed against the moving body 38 by the pressurizing member 34 provided on the first rotating portion 31 via the nonwoven fabric 35. In this configuration, a voltage in a predetermined frequency band is applied to the electro-mechanical energy conversion element 36 and the elastic member 37 is vibrated in the out-of-plane direction, whereby the moving body 38 pressed against the elastic member 37 is applied. The first rotating part 31 including the elastic member 37 can be relatively frictionally driven in the circumferential direction. The first rotating unit 31 is provided with an optical encoder 39 which is one component of the position detecting unit. The first rotary unit 31 is a component of the position detecting unit on the first fixed unit 30 at the radial position facing the first encoder. A certain scale 40 is arranged. With this configuration, it is possible to detect the relative position or relative displacement of the first rotating unit 31 with respect to the first fixed unit 30. The connection part 32 provided in the first rotating part 31 is electrically connected to the electric substrate 11 by the connection between the first covering means 8 and the first rotating part 31, and supplies power to the piezoelectric actuator and the position detecting means. Signal acquisition is possible.

In FIG. 4B, the second fixing portion 41 is fixed to the first covering means 8, positioned and fixed in the radial direction via the fitting portion 41a, and circumferentially via the engaging means (not shown). Is positioned. On the other hand, the second rotating portion 42 is connected to the second fixed portion 41 via the slide bearing 43 so as to be rotatable around the U ′ axis in FIG. The configuration of the piezoelectric actuator and the position detection means is the same as that of the first positioning means 7. The connection portion 32 provided in the second fixing portion 41 is electrically connected to the electric substrate 11 by the connection of the first covering means 8 and the second fixing portion 41, and supplies power to the piezoelectric actuator and the position detection means. And signal acquisition. The second position detecting means can be engaged with the third covering means 10 via the pin hole 44. Note that reference numerals 34 to 40 in FIG. 4B are the same as those in FIG.

The material for forming the first and second positioning means will be described. The first and second fixed parts and the first and second rotating parts directly affect the arrival position accuracy of the medical device relative to the tumor, so that the non-magnetic metal, polyether ether ketone (PEEK), etc. It is desirable to form with hard plastic, ceramics, etc. The elastic member 37 is preferably formed of a non-magnetic metal, high toughness ceramic such as partially stabilized zirconia (PSZ), or the like. The electro-mechanical energy conversion element 36 is preferably formed of a piezoelectric ceramic such as lead zirconate titanate. The moving body 38 is preferably selected from materials for obtaining stable sliding characteristics and wear resistance characteristics with respect to the elastic member 37, such as a hardened magnesium-based aluminum alloy surface by alumite treatment or nitriding treatment, carbon fiber, or the like. Application of fiber reinforced resin such as polyether ether ketone (PEEK) is preferable. The nonwoven fabric 35 is preferably formed of a felt material such as wool or glass wool, and the pressure member 34 is formed of a nonmagnetic metal such as phosphor bronze or a high toughness ceramic such as partially stabilized zirconia (PSZ).

Next, an example of a workflow (surgical procedure) in minimally invasive puncture treatment when using the medical instrument guide device 1 according to the present embodiment will be described. This workflow is described assuming that two people, the sterile person who can only touch sterilized ones and the non-sterile person who handles non-sterilized ones in principle, are responsible for the main work process. It is. Sterile person specifically refers to doctors, assistants, operating room nurses, outside nurses who handle spare instruments, and the like. Non-sterile person refers to nurses and technicians who specialize in handling non-sterile materials only. It is assumed that everything that is touched by the steril person is sterilized or covered with a sterilization sheet. The specific work performed by doctors and nurses attending surgery as an assistant to perform incidental work is omitted here. In this workflow, even if it is sterilized, the part touched by the non-sterile person must be treated as not sterilized. Items that have been sterilized are sealed and packaged in a pouch-shaped bag, and when used, they are opened by a non-sterile person, and the non-sterile person is packed on a sterilized sheet or sterilized bat so as not to touch the contents. Put the finished parts. In the present embodiment, it is assumed that the sterilization sheets 15 to 17, the first covering means 8, the second covering means 4, the third covering means 10, the holding unit 3, and the medical instrument 2 are sterilized. On the other hand, the RF coil 5, the base 6, the first positioning means 7, and the second positioning means 9 are treated as being not sterilized and not sterilized depending on the electrical or mechanical characteristics of the components included therein. .

FIG. 5 shows an example of a workflow. The operation is started (A00). First, a doctor, studio, person puts a sterilized sheet 15 having a hole on the human body (A01). At this time, it is desirable that the puncture point and the center of the hole of the sterilization sheet 15 are substantially aligned, and the hole has a size necessary for operations such as puncture and disinfection.

Next, the second covering means 4 is placed on the sterilizing sheet 15 so that the center person aligns the center of the opening 4a of the second covering means 4 and the hole of the sterilizing sheet 15 (A02). At this time, it is desirable to fix the second covering means 4 to the human body 13 so as not to be displaced by a tape, a band, or other fixing means (not shown).

Next, the serial person installs the RF coil 5 on the second covering means 4 for receiving the RF wave (A03). In this embodiment, the RF coil 5 has an opening larger than the opening of the second covering means 4 as shown in the figure. Further, it is assumed that the RF coil 5 is not sterilized, and as shown in FIG. 3, the RF coil 5 is covered with a sterilization sheet 16 and can be touched by a doctor sterile person.

Next, the non-sterile person installs the base 6 on the second covering means 4 (A04). It is desirable that the second covering means 4 and the base 6 are precisely positioned and fixed by various machine elements such as fitting, positioning pins, keys, bayonet, and snap fit. The base 6 is mounted with an electrical component group for supplying power to the first positioning means 7 and the second positioning means 9 and acquiring signals, and is not sterilized. Next, the non-sterile person incorporates the first positioning means 7 into the base 6 (A05). It is desirable that the base 6 and the first positioning means 7 are precisely positioned and fixed by various machine elements such as fitting, positioning pins, keys, bayonet, and snap fit.

Next, the non-sterile person incorporates the first covering means 8 into the first positioning means 7 while holding the side surface of the first covering means 8 (A06). Here, since the first covering means 8 is sterilized, the non-sterile person has only the side surface of the first covering means 8 and does not touch the opening 8 a of the first covering means 8. It is desirable that the first covering means 8 and the first positioning means 7 are precisely positioned and fixed by various machine elements such as fitting, positioning pins, keys, bayonet, and snap fit. In addition, the first covering means 8 is incorporated into the first positioning means 7, and at the same time, the electrical connection with the electric substrate 11 provided on the first covering means 8 is made by coupling with the connection portion 32. Thus, connection to the electrical component group provided on the base 6 is made.

Next, the non-sterile person incorporates the second positioning means 9 into the first covering means 8 (A07). It is desirable that the first covering means 8 and the second positioning means 9 are precisely positioned and fixed by various machine elements such as fitting, positioning pins, keys, bayonet, and snap fit. In addition, the second positioning means 9 is incorporated into the first covering means 8 and at the same time, the electrical connection with the electric substrate 11 provided on the first covering means 8 is achieved by coupling with the connection portion 32. Assumed to be performed.

Next, the stereo person incorporates the third covering means 10 into the second positioning means 9 (A08). It is desirable that the second positioning means 9 and the third covering means 10 are precisely positioned and fixed by various machine elements such as fitting, positioning pins, keys, bayonet, and snap fit. Further, when the third covering means 10 is incorporated, the doctor stereoperson does not touch the second positioning means 9 that is not sterilized. Next, the doctor serial person incorporates the holding unit 3 into the third covering means 10 (A09), and covers the entire medical instrument guide device 1 with a sterilized sheet 17 having a hole (A10). It is desirable that the size of the hole is formed to be approximately the same as that of the second opening 9a. It is desirable to cover the second opening 9a so that the center of the second opening 9a and the center of the hole of the sterilization sheet are substantially aligned. Next, relative coordinate position and posture measurement of the medical instrument guide apparatus 1 with respect to the human body 13 is performed using MRI which is a visualization means (A11). As a means for measuring the position and orientation of the medical instrument guide device 1, for example, it is desirable to attach a capsule-shaped reference marker containing hydrogen atoms to the medical instrument guide device and measure the position of the reference marker by MRI.

Next, in order to make the tip of the medical device 2 reach the tumor 14 as the puncture target with high accuracy, the rotation angles of the first and second rotational positioning means are calculated, and the first and second rotational positioning means Is set to a predetermined angle (A12). At this time, it is desirable to drive the piezoelectric actuator by control means (not shown) based on the position information of the rotation direction position detection means. Next, the doctor passes the medical instrument 2 through the holding part 3, performs a therapeutic action by ablation (A13), and ends the operation (A14).

As described above, according to the first embodiment, even if the medical instrument guide apparatus 1 includes components that cannot be sterilized, the first covering means 8 is configured to divide the region that must be sterilized and the region that is not sterilized. In addition, since the inside of the openings 10a and 8a can be kept in a sterilized state by being physically partitioned by the third covering means 10, it is possible to provide a medical instrument guide device suitable for a clinical workflow. it can. Furthermore, according to this Embodiment, since a doctor's hand and other sterilized medical instruments can be inserted into the openings 10a, 8a and 4a, the usability for the doctor is improved.

Further, according to the present embodiment, the first covering means 8 can be mass-produced at low cost by resin molding, so that the manufacturing cost is reduced and it is easy to handle as a disposable. Disposable parts can be used at different surgical sites, so the sterilization process can be simplified and the safety in surgery can be improved. Furthermore, by mounting the electric board 11 in the first covering means 8 by in-mold injection, the doctor can touch the electric board 11 that is not sterilized without directly sterilizing the electric board 11. It is possible to construct a clinically adapted surgical workflow.

Furthermore, since the first covering means 8 is formed of transparent polycarbonate (PC), it is possible to confirm the situation inside the medical instrument guiding apparatus 1 from the side. Further, since the first covering means 8 supports or fixes the first and second rotational positioning means over a wide range in the circumferential direction, the first covering means 8 improves the rigidity as a medical instrument guide device and guides the medical instrument. It is possible to improve the positioning accuracy. Further, as in the present embodiment, the first covering means 8 does not have an opening in a direction other than the drive axis direction of the first and second positioning means, so that the doctor can access the non-sterile site through this opening. Can reduce the possibility of access.

As mentioned above, although this Embodiment was demonstrated, the application destination of this invention is not restricted to the puncture operation using an ablation needle. For example, as a medical instrument 2, a cryoneedle used for percutaneous cryotherapy, a biopsy needle used for biopsy surgery for the purpose of collecting tissue for use in pathological examination, and the purpose of searching for a needle puncture route A stylet or the like can be applied. Furthermore, the invention is not limited to the percutaneous puncture operation, but can be applied to all operations in which a human body is injured, a medical device is guided inside the medical device, and the medical device is positioned. For example, laparoscopic surgery and application to an apparatus for holding and guiding an endoscope are conceivable.

Although the example using the nuclear magnetic resonance apparatus MRI is shown as the visualization means in the present embodiment, the visualization means is not limited to MRI, and visualization means using X-rays or ultrasonic waves may be used. In the present embodiment, an example in which the medical instrument guide apparatus 1 is configured using a nonmagnetic material has been described. However, the material can be appropriately changed in accordance with the visualization means. As materials for forming the first, second, and third covering means and the holding portion 3, resin, metal, ceramics, rubber, and the like are applicable. In particular, in this embodiment, since MRI is used as a visualization means, application of a nonmagnetic metal is desirable when using a metal.

In the present embodiment, an example in which capsules containing hydrogen atoms are arranged as means for identifying and registering the relative position of the medical instrument guide device 1 with respect to the human body 13 is not limited to this. A contrast agent capsule such as gadolinium may be used, and any means may be used as long as the posture / position of the medical instrument guide device can be identified by the visualization means. For example, a stage or the like may be provided between the medical instrument guide apparatus 1 and the MRI as means for determining the mechanical position for the MRI.

The configuration of the positioning means is not limited to the configuration of the piezoelectric actuator and the optical position detection means. As the position detection means, an electromagnetic or capacitance encoder may be used in accordance with the visualization means. Further, the scale may be used as a position detecting unit, and the relative rotation angle between the fixed part and the rotating part may be measured. There is no need to provide a piezoelectric actuator inside the positioning means, and a motor or actuator is provided outside the positioning means, and the positioning means has only a transmission mechanism such as a link mechanism or a gear to drive an external motor or actuator. The structure which transmits force may be sufficient. Instead of the piezoelectric actuator, a pneumatic actuator such as McKibben, or an actuator that operates by water pressure or hydraulic pressure may be applied. The positioning means does not need to include an actuator, and may be a guide that has only position detection means and is operated manually. The first and second positioning means, which are rotary type positioning means, have sliding bearings 33 and 43, but smooth relative movement between the fixed portion and the rotating portion by a bearing such as a rolling bearing or an air bearing. May be realized.

In this embodiment, the puncture operation is performed manually by a doctor, but an actuator for performing automatic puncture may be provided separately. For example, the holding unit 3 may include an actuator, a roller, and a position detection unit that automatically feed a medical instrument. At this time, if the holding unit can be configured so that the actuator and the position detection means that perform automatic feeding are sealed with resin by in-mold injection, the actuator and the position detection means provided in the holding unit 3 cannot be sterilized. However, there is a possibility that sterilization of the holding unit 3 may be facilitated.

As in the present embodiment, the third covering means 10 and the holding unit 3 do not have to be formed separately, and may be formed integrally. By making it an integral part, the number of parts can be reduced, and mechanical errors caused by assembly can be reduced.

In the present embodiment, an example in which a sterilized product is packaged in a sealed pouch has been shown for the sterilized product, but any means can be used as long as the sterilized state can be maintained. Absent. For example, whether or not the part is sterilized by color coding may be specified.

In this embodiment, the example in which the base 6, the first positioning means 7, and the second positioning means 9 cannot be sterilized has been described. However, even if these components can be sterilized, they are within the scope of the present invention. is there.

In the present embodiment, the example in which the electric substrate 11 is sealed inside the first covering means 8 is shown. However, even if a sterilizable substrate is attached to the side surface of the first covering means 8. Alternatively, a non-sterile person or the like may assemble an electric substrate that does not support sterilization.

In the present embodiment, in the installation of the first covering means 8 (A06), an example in which the non-sterile person is assembled with the side surface of the first covering means 8 is shown, but the area where the non-sterile person touches May be clearly defined as follows. For example, a grip portion for contact with a non-sterile person may be provided on the outer surface. Further, the area touched by the non-sterile person may be clearly displayed, for example, by color-coding the grip portion. In addition, the outer surface is covered with a sterilized cover or film in advance, and the non-sterile person touches only the side surface of the cover or film, and the cover or film is removed after assembly. A configuration in which the side surface of the means 8 can be touched is also possible.

In the present embodiment, since the second covering means 4 is placed on the sterilization sheet 15, the second covering means 4 itself does not necessarily have to be sterilized. In that case, the second covering means 4 may be handled by the non-sterile person, without touching the second person.

In the present embodiment, since the second covering means 4 is sterilized, the first covering means 8 does not need to cover the inside of the second covering means, and at least covers a base that is not sterilized. At this time, the lower end of the 1st coating | coated means 8 should just exist below D (z-axis negative direction) in FIG.2 (c).

In the present embodiment, since the entire medical instrument guide device 1 is covered with the sterilization sheet 17, the third covering means 10 is not necessarily required. At this time, the staple person needs to attach the holding unit 3 to the second positioning means 9 so as not to touch the second positioning means 9 that is not sterilized. For example, the holding unit 3 may be attached with the sterilization sheet 17 interposed therebetween.

In the present embodiment, the third covering means 10 is shown as a configuration covering the upper end portion and the side surface of the second positioning means 9, but this is not restrictive. For example, the covering range may be expanded by covering the first covering means 8 and the side surfaces of the medical instrument guide device. At this time, in order to avoid the interference between the third covering means and the base 6 due to the rotation of the second positioning means 9, it is desirable to form the interfering portion with a soft member such as soft silicon rubber or vinyl. In this case, the sterilization sheet 17 is not necessarily provided, and the process A10 in the workflow can be omitted.

On the other hand, when the entire medical instrument guide apparatus is covered with the sterilization sheet 17 as in the present embodiment, it is not necessary for the third covering means to cover the side surface of the second positioning means 9. The structure which covers only the upper end surface of may be sufficient. In this case, the holding unit 10 and the third covering unit may be integrally formed so that the steril person can hold the sterilized holding unit.

In the present embodiment, an example has been described in which the steps A03 to A09 are similarly performed on the human body 13 after the second covering means 4 is installed on the human body 13 in the step A02 in the workflow. However, the present invention is not limited to this workflow. Steps A03 to A09 are separately assembled in an environment in which sterilization of the sterilized components is guaranteed to be maintained. In addition, a medical instrument guide device assembled in advance on the human body 13 may be installed. In this case, when grasping a site where the sterilized state is maintained, the stereo person installs the medical instrument guide device, and when grasping a non-sterile site, the non-sterile person installs the medical instrument guide device. It is desirable to do.

As described above, according to the present invention, it is possible to appropriately change the configuration of the medical instrument guide device and the material forming them according to the target of surgery and the workflow of each surgical procedure. Conversely, it is possible to appropriately change the operation workflow according to the configuration of the visualization means and the medical instrument guide apparatus.

(Second Embodiment)
The second embodiment will be described with reference to FIGS. The coordinate system used in each figure is common. In each figure, the same reference numerals are given to those common to the above-described embodiment, and the detailed description is omitted. FIG. 6A is a schematic perspective view of the medical instrument guide apparatus 101 according to the second embodiment, and FIG. 6B is a schematic perspective view of the medical instrument guide apparatus 101 in which the fourth covering means 122 is not displayed. Is shown. FIG. 6 (c) shows a schematic development view of the fourth covering means 122.

In the figure, the first covering means 108 has an opening 108a as in the first embodiment, and a lateral hole 108b is provided on the side surface of the first covering means 108. The edges forming the lateral holes 108b are desirably blended as shown in the figure and do not include sharp portions. The translucent film-like fourth covering means 122 is attached to the side surface of the first covering means 108 so that the region 122b covers the lateral hole 108b. The fourth covering means 122 is provided with a lug 122a, and the fourth covering means 122 can be removed from the first covering means 108 by pulling and pulling the lug 122a. In the present embodiment, the first covering means 108 and the fourth covering means 122 are integrally sterilized.

FIG. 7A is a schematic cross-sectional view of the medical instrument guide device 101 cut along a plane parallel to the zx plane passing through the center of the medical instrument 2. FIG. 7B illustrates the state in which the fourth covering means 122 is removed and the doctor puts the hand 123 into the lateral hole 108b in FIG. 7A. In FIG. 7, the first covering means 108 is fixed to the first positioning means 7 and can be rotated around the LL ′ axis relative to the base 6 in the same manner as in the first embodiment. It is. The second positioning means 9 is fixed to the first covering means 108, and the second rotating portion 42 and the third covering means 10 are the first covering means 108 as in the first embodiment. On the other hand, it is relatively rotatable around the U-U ′ axis. The first covering means 108 uses, for example, polyetheretherketone (PEEK), which is a hard resin, and incorporates the electric substrate 11 by in-mold injection, as in the first embodiment. However, in the present embodiment, since the first covering means 108 has the horizontal holes 108b, it is desirable to have the electric substrate 11 in a place different from the horizontal holes 108b. At this time, the molding temperature of polyetheretherketone (PEEK) is as high as about 400 [° C.], so that in-mold injection is applied to electronic components such as ICs mounted on the electric substrate 11. Desirably, the resin in the molten state is designed so as not to touch, or has a means for protecting the electronic component under a high temperature condition.

As for whether or not each component of the medical instrument guide apparatus 101 is sterilized, the same reference numerals as those in the above embodiment are the same as those in the first embodiment.

FIG. 8 shows an example of a puncture operation workflow in the second embodiment. The operation is started (B00). First, the sterle person puts a sterilized sheet 15 with holes on the human body (B01). At this time, it is desirable that the puncture point and the center of the hole of the sterilization sheet 15 are substantially aligned, and the hole has a size necessary for operations such as puncture and disinfection.

Next, the second covering means 4 is placed on the sterilizing sheet 15 so that the center person aligns the center of the opening 4a of the second covering means and the hole of the sterilizing sheet 15 (B02). At this time, it is desirable to fix the second covering means 4 to the human body 13 so as not to be displaced by a tape, a band, or other fixing means (not shown).

Next, the serial person installs the RF coil 5 on the second covering means 4 for receiving the RF wave (B03). Next, the non-sterile person installs the base 6 on the second covering means 4 (B04). Next, the non-sterile person incorporates the first positioning means 7 into the base 6 (B05). Next, the non-sterile person incorporates the first covering means 108 into the first positioning means 7 while holding the side surface of the first covering means 108 (B06). Here, the first covering means 108 is sterilized integrally with the fourth covering means 122 in advance, and the non-sterile person has the first covering means 108 via the fourth covering means 122. Thus, the first covering means 8 is assembled without directly touching. It is desirable that the first covering means 108 and the first positioning means 7 are precisely positioned and fixed by various machine elements such as fitting, positioning pins, keys, bayonets, snap fits and the like. In addition, the first covering means 108 is incorporated into the first positioning means 7, and at the same time, the electrical connection with the electric substrate 11 provided on the first covering means 108 is achieved by coupling with the connection portion 32. This is a configuration that can be connected to an electrical component group provided on the base 6.

Next, the non-sterile person incorporates the second positioning means 9 into the first covering means 8 (B07). It is desirable that the first covering means 108 and the second positioning means 9 are precisely positioned and fixed by various mechanical elements such as fittings, positioning pins, keys, bayonets, and snap fits. In addition, the second positioning means 9 is incorporated into the first covering means 108, and at the same time, the electrical connection with the electric substrate 11 provided on the first covering means 108 is achieved by coupling with the connection portion 32. Done.

Next, the stereo person incorporates the third covering means 10 into the second positioning means 9 (B08). Next, the non-sterile person pulls the lug 122a while pulling it, thereby removing the fourth covering means 122 (B09). At this time, the non-sterile person is removed without touching the first covering means 108 and the third covering means 10. Next, the staple person incorporates the holding unit 3 into the third covering means 10 (B10), and covers the base 6 with a sterilized sheet 117 having a hole (B11) so that the base 6 is not exposed. The size of the hole is the same as or slightly smaller than the outer dimension of the first covering means 108 on which the second positioning means 9 is mounted, and is covered so as to suppress the exposure of the base 6 as much as possible. Is desirable.

Next, relative coordinate position and posture measurement of the medical instrument guide device 1 with respect to the human body 13 are performed using MRI which is a visualization means (B12). The means for measuring the position and orientation of the medical instrument guide device 1 is the same as in the above-described embodiment. Next, in order to make the tip of the medical device 2 reach the tumor 14 as the puncture target with high accuracy, the rotation angles of the first and second rotational positioning means are calculated, and the first and second rotational positioning means Is set to a predetermined angle (B13). Next, the doctor passes the medical instrument 2 through the holding unit 3, performs a therapeutic action by ablation (B14), and ends the operation (B15).

As mentioned above, according to this embodiment, since a doctor's hand and other sterilized medical instruments can be inserted into the openings 10a, 108a and 4a, the usability for the doctor is improved. In addition, in the process of workflow B14, the doctor can visually check the affected area through the horizontal hole 108b, and insert the doctor's hand (FIG. 7B) or a sterilized medical instrument into the horizontal hole 108b, thereby providing accessibility to the affected area. It is possible to improve.

In the present embodiment, the form in which the fourth covering means 122 formed in a film shape is used as the covering means for covering the lateral hole 108b of the first covering means 108, but the configuration of the fourth covering means 122 is the same. It is not limited. The fourth covering means 122 may be realized by a cap shape made of silicon rubber or the like. At this time, the first and fourth coating means may be sterilized integrally, or may be combined after sterilization individually.

In the present embodiment, the example in which the steps B03 to B10 are similarly performed on the human body 13 after the second covering means 4 is installed on the human body 13 in the step B02 in the workflow has been described. However, the present invention is not limited to this workflow. Steps B03 to B08 and B10 are separately assembled in an environment in which sterilization of the sterilized components is guaranteed to be maintained. A medical device guide device assembled in advance on the human body 13 may be installed. In this case, when grasping a site where the sterilized state is maintained, the stereo person installs the medical instrument guide device, and when grasping a non-sterile site, the non-sterile person installs the medical instrument guide device. It is desirable to do. In this case, it is desirable to remove the fourth covering means (B09) by non-sterile person after the installation of the medical instrument guide device.

As described above, according to the present invention, it is possible to appropriately change the configuration of the medical instrument guide device and the material forming them according to the target of surgery and the workflow of each surgical procedure. Conversely, it is possible to appropriately change the operation workflow according to the configuration of the visualization means and the medical instrument guide apparatus.

(Third embodiment)
The third embodiment will be described with reference to FIGS. 9 to 12. The coordinate system used in each figure is common. In each figure, the same reference numerals are given to those common to the above-described embodiment, and the detailed description is omitted. FIG. 9 is a schematic perspective view of a medical instrument guide apparatus 201 according to the third embodiment. In the figure, an electric substrate 211 is provided on the side surface of the first covering means 208. In addition, the medical instrument guide device 201 includes fifth covering means 224 inside the opening. As shown in the schematic perspective view of FIG. 11, the fifth covering means 224 has a bellows part having an opening 224a, and can be freely deformed in the expansion / contraction direction and the bending direction. The medical instrument is disposed inside the inner wall of the bellows portion (bellows mechanism). FIG. 10 is a schematic cross-sectional view of the medical instrument guide device 201 taken along a plane parallel to the zx plane passing through the center of the medical instrument 2. Note that the freely deformable configuration is not limited to the bellows configuration, and other configurations / members may be used as long as they can be deformed and / or expanded / contracted.

In the present embodiment, the first covering means 208 is treated as a component that cannot be sterilized by exposing the electric substrate 211. The fifth covering means is a component that is made of resin, silicon rubber, or the like and can be easily sterilized. Regarding other constituent elements, the same reference numerals as in the above-described embodiment are used as to whether sterilization is necessary or not.

FIG. 12 shows an example of a workflow. The operation is started (C00). First, the sterle person puts a sterilized sheet 15 with holes on the human body (C01). At this time, it is desirable that the puncture point and the center of the hole of the sterilization sheet 15 are substantially aligned, and the hole has a size necessary for operations such as puncture and disinfection.

Next, the second covering means 4 is placed on the sterilizing sheet 15 so that the center person aligns the center of the opening 4a of the second covering means 4 and the hole of the sterilizing sheet 15 (C02). At this time, it is desirable to fix the second covering means 4 to the human body 13 so as not to be displaced by a tape, a band, or other fixing means (not shown).

Next, the serial person installs the RF coil 5 on the second covering means 4 for receiving the RF wave (C03). Next, the non-sterile person installs the base 6 on the second covering means 4 (C04). Next, the non-sterile person incorporates the first positioning means 7 into the base 6 (C05). Next, the non-sterile person incorporates the first covering means 208 into the first positioning means 7 (C06). It is desirable that the first covering means 208 and the first positioning means 7 are precisely positioned and fixed by various machine elements such as fittings, positioning pins, keys, bayonets, and snap fits. Further, the first covering means 208 is incorporated into the first positioning means 7 and at the same time, the electrical connection with the electric substrate 211 provided on the first covering means 208 is achieved by coupling with the connecting portion 32. Then, connection with the electrical component group provided on the base 6 is made.

Next, the non-sterile person incorporates the second positioning means 9 into the first covering means 208 (C07). It is desirable that the first covering means 208 and the second positioning means 9 are precisely positioned and fixed by various mechanical elements such as fittings, positioning pins, keys, bayonets, and snap fits. Further, the second positioning means 9 is incorporated into the first covering means 208, and at the same time, the electrical connection with the electric substrate 211 provided on the first covering means 208 is achieved by coupling with the connecting portion 32. Made.

Next, the stereo person incorporates the third covering means 10 into the second positioning means 9 (C08). Next, the stage person installs the fifth covering means 224 inside the medical instrument guide apparatus 201 as shown in FIG. 10 (C09). At this time, it is desirable that the stereo person is installed so that the opening 224a and the center of the hole of the sterilization sheet 15 are substantially aligned.

Next, the staple person incorporates the holding unit 3 into the third covering means 10 (C10), and covers the entire medical instrument guide device 1 with a sterilized sheet 17 having a hole (C11). It is desirable that the size of the hole is approximately the same as that of the second opening 9a or the opening 224a of the fifth covering means 224. It is desirable to cover the second opening 9a so that the center of the second opening 9a and the center of the hole of the sterilization sheet are substantially aligned. Next, relative coordinate position and posture measurement of the medical instrument guide apparatus 201 with respect to the human body 13 is performed using MRI which is a visualization means (C12).

Means for measuring the position and orientation of the medical instrument guide device 201 are the same as those in the above-described embodiment. Next, in order to make the tip of the medical device 2 reach the tumor 14 as a puncture target with high accuracy, the rotation angles of the first and second positioning means are calculated, and the first and second rotational positioning means The rotation angle is set to a predetermined angle (C13). In the present embodiment, as the first and second positioning means are driven, the fifth covering means 224 freely changes its shape to follow the movement of the first and third covering means. Next, the doctor passes the medical instrument 2 through the holding unit 3, performs a therapeutic action by ablation (C14), and ends the operation (C15).

According to this embodiment, even if the first covering means 208 cannot be sterilized by a doctor performing puncture treatment through the opening 224a of the fifth covering means 224, the medical instrument guide device 201 is clinically treated. It can be adapted to the workflow.

According to the present embodiment, the fifth covering means 224 can be made disposable by producing it by molding an inexpensive resin or silicon rubber. By using disposable parts, it is possible to improve the safety of the surgery and reduce the total cost by omitting the cleaning and sterilization steps after the surgery.

In this embodiment, the base 7, the first positioning means 7, the first covering means 208, and the second covering means 4 may be assembled in advance. In this case, the steps C04 to C07 can be replaced with one step, the workflow is further simplified, the operation time can be shortened, and the burden on the non-sterile person is reduced.

Although the first covering means 208 has been treated as being incapable of sterilization, a sterilizable thing similar to the first covering means 8 in the first embodiment may be applied. Assuming that the non-sterile person may accidentally touch the inside of the first covering means, the fifth covering means can be used to more securely separate the sterilized area from the non-sterile area. It becomes possible.

In the present embodiment, the example in which the steps C03 to C10 are similarly performed on the human body 13 after the second covering means 4 is installed on the human body 13 in the step C02 in the workflow has been described. However, the present invention is not limited to this workflow. Steps C03 to C08 and C10 are separately assembled in an environment in which sterilization of the sterilized components is guaranteed to be maintained. A medical device guide device assembled in advance on the human body 13 may be installed. In this case, when grasping a site where the sterilized state is maintained, the stereo person installs the medical instrument guide device, and when grasping a non-sterile site, the non-sterile person installs the medical instrument guide device. It is desirable to do. In this case, it is desirable to install the fifth covering means (C09) by a non-sterile person after the medical instrument guide device is installed, in order to avoid interference between the holding unit 3 and the fifth covering means. The escape portion may be provided in the fifth covering means.

As described above, according to the present invention, it is possible to appropriately change the configuration of the medical instrument guide device and the material forming them according to the target of surgery and the workflow of each surgical procedure. Conversely, it is possible to appropriately change the operation workflow according to the configuration of the visualization means and the medical instrument guide apparatus.

(Fourth embodiment)
The fourth embodiment will be described with reference to FIGS. 13 and 14. The coordinate system used in each figure is common. In each figure, the same reference numerals are given to those common to the above-described embodiment, and the detailed description is omitted.

FIG. 13 shows a schematic perspective view of the third covering means 310 with the bellows mechanism in the present embodiment. FIG. 14 is a schematic cross-sectional view of the medical instrument guide device 301 in the fourth embodiment cut along a plane parallel to the zx plane passing through the center of the medical instrument 2. In the present embodiment, the first covering means 208 is treated as a component that cannot be sterilized by exposing the electric substrate 211 as in the third embodiment.

In this embodiment, the third covering means with a bellows mechanism is composed of a bellows mechanism 310d, a covering portion 310b, and a connecting portion 310c, all of which are configured to be integrally sterilizable. The bellows mechanism 310d is formed of a general resin, silicon rubber, or the like, and the covering portion 310b is formed of a polyether ether ketone (PEEK) that is a hard resin. In order to restrain the covering portion 310b and the bellows mechanism 310d from each other and to allow relative displacement between them, the connecting portion 310c is preferably formed of natural rubber, nitrile rubber or the like having high stretchability. Regarding other constituent elements, the same reference numerals as in the above-described embodiment are used as to whether sterilization is necessary or not.

An example of a surgical procedure (workflow) when performing a puncture operation using the medical instrument guide device 301 described above can be described with reference to FIG. First, steps A01 to A07 are the same as those described with reference to FIG. However, the difference from the details of step A06 of the first embodiment is that the first covering means 208 is not sterilized.

Next, the staple person incorporates the third covering means 310 with the bellows mechanism into the second positioning means 9 (A08). At this time, it is desirable to install the stylon person so that the center of the opening 310a and the hole of the sterilization sheet 15 are substantially aligned, and the diameter of the opening 310a is preferably larger than the hole of the sterilization sheet 15. It is desirable that the second positioning means 9 and the third covering means 310 are precisely positioned and fixed by various machine elements such as fitting, positioning pins, keys, bayonet, snap fit, and the like. Further, when the third covering means 310 is incorporated, the steril person does not touch the non-sterilized second positioning means 9. Next, the staple person incorporates the holding portion 3 into the third covering means 310 with the bellows mechanism (A09), and covers the entire medical instrument guide device 301 with the sterilized sheet 17 having a hole (A10). It is desirable that the size of the hole is formed to be approximately the same size as the second opening 9a or the opening 310a of the third covering means 310 with the bellows mechanism. It is desirable to cover the second opening 9a so that the center of the second opening 9a and the center of the hole of the sterilization sheet are substantially aligned. The remaining steps A11 to A14 are performed in the same manner as described with reference to FIG. These detailed explanations are omitted. According to the present embodiment, as the first and second positioning means are driven, the bellows mechanism 310d of the third covering means 310 with the bellows mechanism can be freely changed in shape to move the first and second covering means. Follow. Further, according to the present embodiment, the installation of the third covering means 310 with the bellows mechanism causes the connecting portion 310c to connect the covering portion 310b and the bellows mechanism 310d over the entire circumference. It is possible to prevent exposure of the non-sterile part. In addition, the present embodiment in which the third covering means and the fifth covering means (bellows mechanism) described in the third embodiment are integrated, thereby reducing the number of component components of the medical instrument guide device 301 and the sterilization process. There is an advantage that the workflow can be simplified.

In the present embodiment, an example in which the connecting portion 310c is formed of a stretchable rubber has been described. However, a material having low stretchability is applied, and the bellows mechanism of the bellows 310d is bent instead of expanding and contracting the connecting portion 310c. Alternatively, the movement of the first and second covering means may be followed using elasticity. Furthermore, the covering portion 310b, the bellows 310d, and the connecting portion 310c do not need to be formed of different materials, and may be formed of the same material and integrally by injection molding. Since the number of man-hours is reduced, it leads to cost reduction and it is easy to handle as disposable parts.

Further, as described with reference to FIG. 5, the medical instrument guide assembled in advance in the environment in which it is ensured that the sterilized state of the sterilized components is maintained, and pre-assembled on the human body 13 before the step A10. A device may be installed.

As described above, according to the present invention, it is possible to appropriately change the configuration of the medical instrument guide device and the material forming them according to the target of surgery and the workflow of each surgical procedure. Conversely, it is possible to appropriately change the operation workflow according to the configuration of the visualization means and the medical instrument guide apparatus.

(Fifth embodiment)
The fifth embodiment will be described with reference to FIGS. 15 and 16. The coordinate system used in each figure is common. In each figure, the same reference numerals are given to those common to the above-described embodiment, and the detailed description is omitted. FIG. 16 is a schematic cross-sectional view of the medical instrument guide device 401 according to the fifth embodiment taken along a plane parallel to the zx plane passing through the center of the medical instrument 2. In the present embodiment, the first covering means 208 is treated as a component that cannot be sterilized by exposing the electric substrate 211 as in the third embodiment.

FIG. 15 shows a schematic perspective view of the second covering means 404 with a bellows mechanism in the present embodiment. In this embodiment, the 2nd coating | coated means 404 with a bellows mechanism is comprised from the bellows-shaped coating | coated part 404d, the coating | coated part 404b, and the connection part 404c, All make it the structure which can be sterilized integrally. The covering portion 404d is formed of a general resin, silicon rubber, or the like, and the covering portion 404b is formed of a polyether ether ketone (PEEK) that is a hard resin. In order to constrain the covering portion 404b and the covering portion 404d (bellows mechanism), the connecting portion 404c provided in the covering portion 404b restricts the movement of the covering portion 404d in the vertical direction (z-axis direction). The covering means 404b not only functions as a covering, but also serves as a support member that supports the bellows-shaped covering portion 404d and stabilizes the position. In addition, coordinate axes 404s, 404i, 404r, and 404l of the human body coordinate system are engraved on the covering portion 404b as rough marks when the cover portion 404b is installed on the human body 13. As viewed from the human body 13, 404s indicates the head direction (superior), 404i indicates the lower limb direction (inferior), 404r indicates the right hand direction (right), and 404l indicates the left hand direction (left). Regarding other constituent elements, the same reference numerals as in the above-described embodiment are used as to whether sterilization is necessary or not.

An example of a surgical procedure (workflow) when performing a puncture operation using the medical instrument guide device 401 described above will be described with reference to FIG. First, the process of A01 is performed in the same manner as in FIG. 5, and the process of A02 is the same as that described in FIG. The second covering means 404 with a bellows mechanism is placed on the sterilization sheet 15 (E02). As in the case of FIG. 5, it is desirable to fix the second covering means 404 to the human body 13 with a tape, a band, or other fixing means (not shown) so as not to shift. Next, the stationer person installs the RF coil 5 for receiving the RF wave on the second covering means 404 with the bellows mechanism (E03). And the process similar to A03 thru | or A12 demonstrated in FIG. 5 is continued with respect to the medical device guide apparatus 401 in 5th Embodiment. The detailed explanation here is omitted.

According to the present embodiment, since the connecting portion 404c connects the covering portions 404b and 404d over the entire circumference by the installation of the second covering means 404 with the bellows mechanism, the non-sterile is prevented due to the expansion and contraction of the bellows. Preventing the exposure of the part and ensuring separation from the non-sterile part near the skin leads to further improvement of the safety of the operation. Further, according to the present embodiment in which the second covering means and the fifth covering means are integrated, the number of parts constituting the medical instrument guide device 401 is reduced, and the second covering means 404 is made disposable so that it can be sterilized. There is an advantage that the process and the workflow can be simplified.

In the present embodiment, an example is shown in which the connecting portion 404c combines the covering portion 404b and the covering portion 404d (bellows mechanism) so as to restrict the vertical movement of the covering portion 404d (bellows mechanism). The covering portion 404b and the covering portion 404d may be integrally formed by injection molding or the like. In this case, since the number of parts manufacturing steps can be further reduced, the cost can be reduced and it can be easily handled as a disposable part. Further, by forming the side surface of the covering portion 404d (bellows mechanism) into a male screw shape and the connecting portion 404c as a female screw shape, the covering portion 404d (bellows mechanism) may be connected to be screwed into the covering portion 404b. Good. At this time, a bayonet mechanism may be employed in addition to the screw shape.

In this embodiment, the sterilization sheet 15 is put on the human body 13 in FIG. 16, but since the second covering means 404b is sterilized, the sterilization sheet 15 in FIG. 16 and the process A01 in FIG. It can be omitted as appropriate.

Further, as described with reference to FIG. 5, the medical instrument guide assembled in advance in the environment in which it is ensured that the sterilized state of the sterilized components is maintained, and pre-assembled on the human body 13 before the step A10. A device may be installed.

As described above, it is possible to appropriately change the configuration of the medical instrument guide device and the material forming them according to the target of surgery and the workflow of each surgical procedure. Conversely, it is possible to appropriately change the operation workflow according to the configuration of the visualization means and the medical instrument guide apparatus.

(Sixth embodiment)
The sixth embodiment will be described with reference to FIG. The coordinate system used in each figure is common. In each figure, the same reference numerals are given to those common to the above-described embodiment, and the detailed description is omitted. FIG. 17A shows a schematic perspective view of the medical instrument guide device 501, and FIG. 17B is a plane parallel to the zx plane passing through the center of the medical instrument 2, and the medical instrument in the sixth embodiment. The schematic sectional drawing at the time of cutting | disconnecting the instrument guide apparatus 501 is shown. FIG. 17C is an enlarged view of a region E surrounded by a broken line in FIG.

In FIG. 17, 506 is a base, 508 is a first covering means, and 504 is a second covering means. The first covering means 508 and the second covering means 504 have openings 508a and 504a, respectively. The first covering means 508 incorporates the electric substrate 11 by in-mold injection, as in the first embodiment. In the present embodiment, the first covering means 508 and the second covering means 504 are handled as sterilizable members, and the base 506 is handled as a part that cannot be sterilized by exposure of electronic parts. As shown in FIG. 17 (c), the first covering means 508 and the second covering means 504 form a labyrinth mechanism 520 and can be rotated around the LL ′ axis without relative interference. is there. Regarding other constituent elements, the same reference numerals as in the above-described embodiment are used as to whether sterilization is necessary or not.

In this medical instrument guiding apparatus 501, the shapes of the first covering means 508 and the second covering means 504 are the same as those of the first covering means 8 and the second covering means 4 described in the first embodiment. Is different. However, similarly, the first covering means and the second covering means can be installed, and an example of a surgical procedure (workflow) when performing the puncture operation described with reference to FIG. 5 is applicable.

According to this embodiment, the first covering means 508 covers a part of the first opening 7a that is not sterilized, and the second covering means 504 is not sterilized and the first base 506 and the first positioning means 7 are covered. The openings 506a and 7a are partially covered. Further, the first covering means 508 and the second covering means 504 form a labyrinth mechanism 520, so that the non-sterile area is prevented from being exposed to the sterilization area, and wear powder such as a bearing flows into the sterilization area. Risk can be kept low, leading to further improvement in the safety of surgery. Moreover, there exists an advantage which can simplify a sterilization process and a workflow by making the 1st and 2nd coating | coated means into a disposable part.

In this embodiment, in FIG. 16, the sterilization sheet 15 is put on the human body 13, but since the second covering means 504 is sterilized, the sterilization sheet 15 in FIG. Step A01 can be omitted as appropriate.

Further, as described with reference to FIG. 5, the medical instrument guide assembled in advance in the environment in which it is ensured that the sterilized state of the sterilized components is maintained, and pre-assembled on the human body 13 before the step A10. A device may be installed.

In the medical instrument guide apparatus 501 shown in FIG. 17, the second covering means 504 is provided for the first positioning means 7, and the first covering means 508 is provided for the second positioning means 9. Explained the case. However, it is not limited to this. For example, the first covering means may be provided for the first positioning means 7. That is, you may comprise the 1st coating | coated means and the 2nd coating | coated means 504 so that the 1st opening part of the 1st positioning means 7 may be covered.

As described above, it is possible to appropriately change the configuration of the medical instrument guide device and the material forming them according to the target of surgery and the workflow of each surgical procedure. Conversely, it is possible to appropriately change the operation workflow according to the configuration of the visualization means and the medical instrument guide apparatus.

(Other embodiments)
The present invention supplies a program that realizes one or more functions of the above-described embodiments to a system or apparatus via a network or a storage medium, and one or more processors in a computer of the system or apparatus read and execute the program This process can be realized. It can also be realized by a circuit (for example, ASIC) that realizes one or more functions.

The present invention is not limited to the above embodiment, and various changes and modifications can be made without departing from the spirit and scope of the present invention. Therefore, in order to make the scope of the present invention public, the following claims are attached.

This application claims priority based on US Provisional Patent Application No. 62 / 184,083 filed on June 24, 2015, the entire contents of which are incorporated herein by reference.

DESCRIPTION OF SYMBOLS 1 Medical instrument guide apparatus, 2 Medical instrument, 3 Holding part, 2nd coating | coated means,
5 RF coil, 6 base, 7 first positioning means, 8 first covering means,
9 Second positioning means, 10 Third covering means, 11 Electrical board, 12 Connector,
13 human body, 14 tumor, 15, 16, 17 sterilized sheet

Claims (45)

1. A holding part for holding and guiding at least one medical device;
   A ring-shaped positioning means for determining the position of the holding portion by a rotation operation, the ring-shaped positioning means having an opening for a doctor to access the medical instrument;
   And at least one covering means that covers at least a part of the opening and rotates together with at least a part of the ring-shaped positioning means,
   The medical instrument guide apparatus, wherein the covering means covers the positioning means, and the medical instrument is arranged with respect to the covered positioning means.
2. A holding part for holding and guiding at least one medical device;
   Positioning means for determining the position of the holding portion, and having a first opening and a second opening;
   At least one covering means having an inner wall,
   A first covering portion covering at least a part of at least one of the first and second openings;
   A second covering portion covering at least a part of at least one of the first and second openings, and
   At least one of said 1st coating | coated part and said 2nd coating | coated part covers at least one part of said 2nd opening part, The medical device guide apparatus characterized by the above-mentioned.
3. The positioning means is rotated to change the first rotation angle and has a first opening, and the positioning means is rotated to change the second rotation angle and has a second opening. The medical instrument guide apparatus according to claim 2, further comprising: a second positioning unit including:
4. The medical instrument guiding apparatus according to claim 2, wherein the first covering portion covers the first and second openings.
5. 3. The medical instrument guide device according to claim 2, wherein the first and second covering portions respectively cover different openings of the first and second openings.
6. 6. The medical instrument guiding apparatus according to claim 5, wherein at least one of the first and second covering portions covers the first and second openings.
7. It further has a connection part,
   The medical instrument guide device according to claim 5, wherein the first and second covering portions and the connection portion form the inner wall.
8. The first covering portion rotates relative to the second covering portion, and the first and second covering portions leave a gap in a direction at least perpendicular to the rotation axis of the first covering portion. The medical instrument guide device according to claim 5, wherein the medical instrument guide devices partially overlap each other.
9. The medical instrument guiding apparatus according to claim 5, wherein the first covering portion covers the second opening.
10. The covering means further includes a third covering portion,
    6. The medical instrument guide device according to claim 5, wherein the third covering part completely covers the second opening part together with the first covering part.
11. The third covering portion rotates relative to the first covering portion, and the first and third covering portions leave a gap in a direction at least perpendicular to the rotation axis of the first covering portion. The medical instrument guide device according to claim 10, wherein the medical instrument guide devices partially overlap each other.
12. The medical instrument guiding apparatus according to claim 10, wherein the third covering portion and the holding portion are integrally formed.
13. The positioning means rotates to change a first rotation angle and has a first opening, and rotates to change a second rotation angle and to change a second opening. The medical instrument guide device according to claim 10, further comprising at least a second positioning portion including
14. The third covering portion is at least one of an upper end portion of the second positioning portion, an outer surface of the second positioning portion, an outer surface of the first covering portion, or an outer surface of the first positioning portion. The medical instrument guiding apparatus according to claim 13, wherein the medical instrument guiding apparatus is covered.
15. 3. The medical instrument guide device according to claim 2, wherein the first and second covering portions are integrally formed.
16. The first covering portion has an intermediate portion disposed between the first and second openings, and a through hole provided toward the intermediate portion and penetrating the inside and the outside,
    The medical instrument guide device according to claim 2, further comprising a removable fourth covering portion that covers the through hole.
17. The connection portion includes an intermediate portion disposed between the first and second openings, and a through hole provided toward the intermediate portion and penetrating the inside and the outside.
    The medical instrument guide device according to claim 7, further comprising a fourth covering portion that covers the through hole and is removable.
18. Inside the opening, has a deformable fifth covering portion,
    The medical instrument guide device according to claim 2, wherein the medical instrument is disposed inside the fifth covering portion.
19. The medical instrument guiding apparatus according to claim 18, wherein the fifth covering portion has a bellows mechanism.
20. A deformable fifth covering portion is provided inside the opening, and the fifth covering portion is deformed in conjunction with the operation of the first positioning portion and / or the second positioning portion. The medical instrument guiding apparatus according to claim 3, wherein
21. 21. The medical instrument guiding apparatus according to claim 20, wherein the fifth covering portion and the second covering portion are integrally formed or coupled to each other.
22. A third covering portion covering at least a part of the second opening;
    21. The medical instrument guide device according to claim 20, wherein the fifth covering means and the third covering portion are integrally formed or coupled to each other.
23. 23. The medical instrument guide device according to claim 22, wherein the covering means is formed of a transparent material that transmits visible light.
24. The medical instrument guiding apparatus according to claim 7, wherein the covering means is formed of a transparent material that transmits visible light.
25. The first positioning means includes a first fixing portion and a first rotating portion, and the second positioning means includes a second fixing portion and a second rotating portion, and the first covering means. Is coupled to the first rotating part via the first coupling means, is coupled to the second fixing part via the second coupling means, and is coupled to the second covering means and the first The medical instrument guide device according to claim 3, wherein the fixing portion is integrally formed.
26. The first positioning means includes a first fixing portion and a first rotating portion, and the second positioning means includes a second fixing portion and a second rotating portion, and the first covering means. Is coupled to the first rotating part via the first coupling means, is coupled to the second fixed part via the second coupling means, and is coupled to the third covering means and the second fixing part. The medical instrument guide device according to claim 3, wherein the rotating part is integrally formed.
27. The first positioning means includes a first fixing portion and a first rotating portion, and the second positioning means includes a second fixing portion and a second rotating portion, and the first covering means. Is coupled to the first rotating part via the first coupling means, and coupled to the second fixed part via the second coupling means, and the first covering means comprises an electric substrate. The electric board and the first positioning means and the second positioning means are electrically connected by the respective coupling of the first coupling means and the second coupling means. The medical instrument guide apparatus according to claim 3.
28. 28. The medical instrument guiding apparatus according to claim 27, wherein the electric board is disposed inside the covering means by molding.
29. The positioning unit includes at least a first positioning unit that can rotate and change a first rotation angle, and a second positioning unit that can rotate and change a second rotation angle. Item 14. A medical instrument guide device according to Item 1.
30. 3. The medical instrument guiding apparatus according to claim 2, wherein the covering means has a first covering portion and a second covering portion, and each covers at least a part of the opening.
31. It further has a connection part,
    The medical instrument guiding apparatus according to claim 30, wherein the first covering portion, the second covering portion, and the connecting portion form the inner wall.
32. The first covering portion rotates relative to the second covering portion, and the first and second covering portions leave a gap in a direction at least perpendicular to the rotation axis of the first covering portion. The medical instrument guide device according to claim 30, wherein the medical instrument guide devices partially overlap each other.
33. The covering means further includes a third covering portion,
    The medical instrument guide device according to claim 30, wherein the third covering portion completely covers the opening together with the first covering portion.
34. The third covering portion rotates relative to the first covering portion, and the first and third covering portions leave a gap in a direction at least perpendicular to the rotation axis of the first covering portion. 34. The medical instrument guide device according to claim 33, wherein the first and third covering portions partially overlap each other to form the opening.
35. 34. The medical instrument guide device according to claim 33, wherein the third covering portion and the holding portion are integrally formed.
36. The third covering portion is at least one of an upper end portion of the second positioning portion, an outer surface of the second positioning portion, an outer surface of the first covering portion, or an outer surface of the first positioning portion. The medical instrument guide apparatus according to claim 35, wherein the medical instrument guide apparatus covers the medical device.
37. 3. The medical instrument guide device according to claim 2, wherein the first covering portion and the second covering portion are integrally formed.
38. The first covering portion has an intermediate portion and a through hole provided toward the intermediate portion and penetrating the inside and the outside.
    The medical instrument guide device according to claim 2, further comprising a removable fourth covering portion that covers the through hole.
39. The connection portion includes an intermediate portion and a through hole provided toward the intermediate portion and penetrating the inside and the outside.
    32. The medical instrument guide device according to claim 31, further comprising a fourth covering portion that covers the through hole and is removable.
40. Inside the opening, has a deformable fifth covering portion,
    32. The medical instrument guide device according to claim 31, wherein the medical instrument is disposed inside the fifth covering portion.
41. 41. The medical instrument guide device according to claim 40, wherein the fifth covering portion has a bellows mechanism.
42. A deformable fifth covering portion is provided inside the opening, and the fifth covering portion is deformed in conjunction with the operation of the first positioning portion and / or the second positioning portion. The medical instrument guide apparatus according to claim 31, wherein the medical instrument guide apparatus is a medical instrument guide apparatus.
43. 43. The medical instrument guide device according to claim 42, wherein the fifth covering portion and the second covering portion are integrally formed or coupled to each other.
44. The medical instrument guiding apparatus according to claim 1, wherein the covering means is formed of a transparent material that transmits visible light.
45. 32. The medical instrument guiding apparatus according to claim 31, wherein the covering means is made of a transparent material that transmits visible light.

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