JP7030682B2 - Medical support device - Google Patents

Description

The present invention relates to a medical support device for holding and positioning a needle. More specifically, the present invention relates to the positioning of one or more needles in puncture treatment.

In medical procedures, there is an increasing need for minimally invasive treatment to improve the patient's quality of life (QOL). In such situations, percutaneous puncture treatments such as percutaneous puncture resection and percutaneous puncture cryosurgery have been developed as minimally invasive treatments.

However, in the case of percutaneous puncture treatment, the puncture target site cannot be directly seen, and therefore the puncture needs to be performed based on the medical image obtained by using an MRI device, a CT device, or the like. However, since these medical imaging devices are used, images cannot be obtained in real time. Images can be obtained in real time using special MRI equipment, but in that case it is necessary to carry out the work in a small space. In either case, it is difficult to reach the target accurately and therefore this process is time consuming.

Under such circumstances, the puncture support mechanism shown in US Patent Application Publication No. 2011/0190787 has been proposed as medical support using medical images obtained by using an MRI device, a CT device, or the like. According to U.S. Patent Application Publication No. 2011/0190787, a marker attached to the device is recognized on a medical image and the posture of the device is found. Based on this posture and the position of the puncture target, the direction and depth of the puncture can be determined and the puncture is assisted. With this mechanism, the needle can be inserted from the same insertion point towards different puncture targets, thus minimizing puncture trauma. In addition, the mechanism can be reduced in size and the patient can enter an existing medical imaging device with the device attached.

Surgery performed with the instrument inserted at multiple different target positions is increasingly being used as a percutaneous puncture treatment.

However, when the surgeon attempts to insert the instrument into multiple different target positions, the instrument will not change unless the placement is changed, as in the configuration disclosed in U.S. Patent Application Publication No. 2011/0190787. It is inserted from the same insertion point. Therefore, when the surgeon attempts to insert the second and next instruments, the instruments interfere with each other and cannot perform the insertion of more than one instrument.

In U.S. Patent Application Publication No. 2005/0080333, insertion of multiple instruments at different target positions is accomplished using grid positioning units. However, a dedicated carrier is required, which makes the device large and difficult to use in existing imaging devices.

In view of such problems, it is desirable to avoid interference between instruments by a simple mechanism. Therefore, there is a need for a device that can be used with multiple instruments (such as needles) that allows the device to be placed at the target site with little interference between the devices without the need to re-install the device in the patient. It is said that.

A medical support device, the first rotating element having a first rotation axis and a first rotation degree of rotation, and a second rotation axis and a second rotation degree of rotation. A second rotating element attached to the second rotating element, the second rotating axis intersecting the first rotating axis, which can be attached to a second rotating element and a second rotating element of the needle-like instrument. A medical assistance device is provided that comprises at least one needle guide configured to guide the direction of insertion. In this device, at least one needle guide guides the first needle-like device from the first puncture start point and guides the second needle-like device to a second puncture start point different from the first puncture start point. The at least one needle guide includes at least one guide portion for guiding from the point, and the at least one needle guide is in the first position when guiding the first needle-shaped instrument and the second when guiding the second needle-shaped instrument. The first needle guide includes a first guide portion that guides the needle-like device from the first puncture start point, and the second needle guide includes the needle-like device in the second puncture. Includes a second guide portion that guides from the starting point.

Some embodiments are medical support devices, at least one rotatable portion having at least one degree of rotatability and at least one needle guide attached to the rotatable portion and having a guide portion. The guide portion is provided with a needle guide, which is configured to (a) guide the insertion direction of the needle-shaped instrument and (b) separate from the needle-shaped instrument after the needle-shaped instrument is inserted. It is configured to guide the needle-like device to the first puncture start point when positioned at position 1, and the guide portion is provided when the needle guide is positioned at position 2 or the second needle guide. The guide portion of provides a medical support device configured to guide the needle-like device to a second puncture start point that is different from the first puncture start point.

Another embodiment is a method, the step of attaching the medical support device to the patient, wherein the medical support device comprises a first rotating element, a second rotating element, and at least two needle guides. , Attaching steps, defining at least first and second locations within the patient for image data-based therapeutic intervention, attaching the first needle to the first needle guide, and first. The step of attaching one needle guide to the medical support device and the medical support device to rotate the first rotating element and the second rotating element to the position defined by the first location for therapeutic intervention. A step to instruct, a step to insert the first needle into the patient, a step to release the first needle from the medical support device, a second needle attached to the second needle guide, and a second needle guide. A step of attaching to the medical support device and a step of instructing the medical support device to rotate the first and second rotating elements to the position defined by the second location for therapeutic intervention. The step of inserting the second needle into the patient, the second needle not in contact with the first needle during insertion into the patient, the step of inserting and the step of releasing the second needle from the medical support device. Provides methods, including and.

Further objects, features, and advantages of the invention will be apparent from the following detailed description, in combination with the accompanying figures showing exemplary embodiments of the invention.

It is a figure which shows the schematic structure of the mechanical part of 1st Embodiment. It is a figure which shows the schematic structure of the 1st Embodiment. It is a three-sided view of the first example of a needle guide. FIG. 3A is a front view. FIG. 3B is a plan view. FIG. 3C is a perspective view. It is a three-sided view of the second example of a needle guide. FIG. 4A is a front view. FIG. 4B is a plan view. FIG. 4 (c) is a perspective view. It is a figure of the state of the needle during puncture. It is a figure which shows the schematic structure of the mechanical part of the 2nd Embodiment. It is the schematic sectional drawing of the mechanical part of the 2nd Embodiment. It is a block diagram of the 2nd Embodiment. It is a block diagram of 1st Embodiment. It is a block diagram of the computer system described in this specification. It is a figure which shows the 1st needle guide mechanism which has a degree of freedom. FIG. 3 is a three-view view of a second needle guide mechanism having a degree of freedom. FIG. 11A is a front view. FIG. 11B is a plan view. FIG. 11 (c) is a side view. FIG. 3 is a three-view view of a third needle guide mechanism having a degree of freedom. FIG. 12A is a front view. FIG. 12B is a plan view. FIG. 12 (c) is a side view. It is a figure which shows the schematic structure of the mechanical part of the 3rd Embodiment. It is a cutting view of the schematic structure of the mechanical part of the third embodiment. It is a figure which shows the schematic structure of the mechanical part of 4th Embodiment. It is a cutting view of the schematic structure of the mechanical part of the fifth embodiment. It is a cutting view of the schematic structure of the mechanical part of the fifth embodiment. FIG. 6 is a schematic diagram showing a conical volume portion through which a needle-shaped instrument can pass through while the medical support device is rotating. It is a schematic diagram which shows the conical volume part of two needle-shaped instruments having different heights of needle guides. It is a schematic diagram which shows the conical volume part of two needle-shaped instruments which the angle of a needle guide is different.

In the following description, the disclosed illustration will be referred to, which is an example of an embodiment in which the present invention can be carried out. However, it should be understood that one of ordinary skill in the art may develop other structural and functional modifications without departing from the novelty and scope of this disclosure.

First Embodiment Configuration The first embodiment of the present invention will be described with reference to FIGS. 1, 5 (a) and 5 (b), and FIGS. 6 to 6. First, the schematic configuration of the mechanical part of the medical support device of the present embodiment will be described with reference to FIG.

Mechanical Configuration In FIG. 1, the structure of each rotating element or the movable portion within the rotating element is omitted for simplicity. First, the base 15 of the mechanical portion 1 is secured and mounted by a fixation unit (not shown) on the object to be punctured.

The mounting portion of the annular or ring-shaped first rotating element 11 (also defined as the rotating mechanism) is attached to the base 15.

Next, the mounting portion of the arc-shaped second rotating element 12 (also defined as the rotating mechanism) is attached to the movable portion of the rotating element 11. At this time, as shown in FIG. 2, in the rotation element 11 and the rotation element 12, the rotation axis 22 of the second rotation element 12 representing the rotation center of the movable portion of the second rotation element 12 is the first. It is configured to be perpendicular to the rotation axis 21 of the first rotation element 11 representing the rotation center of the movable portion of the rotation element 11.

The needle guide 13 is attached to a movable portion of the second rotating element 12.

The needle guide 13 has a notch. By inserting the needle-shaped instrument 10 along the notch, the insertion direction of the instrument 10 is guided.

The first rotating element 11 and the second rotating element 12 are optionally provided with scale-shaped position detecting units 6a and 6b, and the scale-shaped position detecting unit detects the rotation angle of each rotating element. Can be done.

Therefore, in use, the medical assistance device is positioned on an object such as the human torso, and the two rotating elements are optimal or predetermined for the needle-like device when inserted along the notch of the needle guide. It is rotated to define the orbit.

Detailed Description of Each Mechanism The arrangement of the degrees of freedom of each rotating element of the mechanical part 1 and the range of its movement will be described with reference to FIG.

In FIG. 2, the needle guide 13 and the position detection units 6a and 6b are omitted for simplicity. The needle-shaped instrument 10 is also omitted. Instead, it draws a straight line 20 that indicates the direction of the instrument.

First, a method of defining the coordinate axes in the present embodiment will be described. The XZ plane is defined as a plane containing the bottom surface of the mechanical portion, and the Y axis is defined as an axis perpendicular to the XY plane. Hereinafter, the coordinates (x, y, z) indicate the values of the X-axis, the Y-axis, and the Z-axis.

The movable portion of the first rotating element 11 is arranged so that the rotating shaft 21 is perpendicular to the bottom surface. In FIG. 2, the movable portion of the first rotating element 11 is arranged so that the rotating shaft 21 coincides with the Y axis. In this embodiment, the movable portion of the first rotating element 11 is rotatable by at least ± 180 degrees.

Next, the movable portion of the second rotating element 12 is arranged so that the rotating shaft 22 is perpendicular to the rotating shaft 21 of the first rotating element 11. In FIG. 2, the movable portion of the second rotating element 12 is arranged so that the rotating shaft 22 coincides with the Z axis. However, the rotating shaft 22 is not fixed. When the movable portion of the first rotating element 11 is rotated at an arbitrary angle, the rotating shaft 22 is also rotated. For example, when the first rotating element 11 is rotated 90 degrees, the rotation axis 22 coincides with the X axis.

When 0 degrees is defined as the position corresponding to the Y-axis, the movable portion of the second rotating element 12 is rotatable in both positive and negative directions with respect to it.

The needle guides 13 facing different directions shown in FIGS. 3 (a) to 3 (c) and FIGS. 4 (a) to 4 (c) are interchangeable with each other. Therefore, some needle guides having the configurations of FIGS. 3 and / or 4 can be positioned on the needle guides. 3 (a) and 4 (a) are front views, FIGS. 3 (b) and 4 (b) are plan views, and FIGS. 3 (c) and 4 (c) are isometric views. Is. The needle guide 13b shown in FIGS. 4 (a) to 4 (c) is provided with a notch, whereby the needle-shaped instrument 10 is rotated by the rotation shaft 21 of the first rotation element 11 and the rotation of the second rotation element 12. It guides in a direction that does not pass through the intersection 23 of the shaft 22.

On the other hand, the needle guide 13a shown in FIGS. 3 (a) to 3 (c) is also provided with a notch, thereby guiding the needle-shaped instrument 10 in a direction passing through the intersection 23 of the two rotation axes.

In this embodiment, for the sake of simplicity, a description will be given regarding the case where only the needle guide 13b shown in FIGS. 4 (a) to 4 (c) is used. Similarly, in FIG. 4, the needle guides can be formed at different angles with respect to the notch. This realizes a needle guide that guides the needle to an inlet point that has different proximalities to the intersection of the axes of rotation of the two rotating elements.

In some embodiments, the shape of the notch in the needle guide is triangular, as shown in FIGS. 3 and 4. In other embodiments, the notch is a semicircle, a square, a rectangle, or some other shape. In another embodiment, instead of the notch as described herein, the needle guide 13 may include a through hole that can be used to guide the needle. In some embodiments, in addition to the notch, additional elements can be incorporated as part of the needle guide. This additional element may be configured to hold the needle and then release it after positioning, for example, to allow the patient to resume breathing after placement of the needle.

Operation FIG. 8B is a block diagram showing a system configuration including a user in the present embodiment. The operation of each block and the input and output signals in this embodiment will be described with reference to FIG. 8B.

The user designates a plurality of target positions in the coordinate system of the medical support device by the input device 200.

The angle calculation unit 2 finds two combinations of the target angles of the two rotating elements for each input target position, and outputs these to the interference analysis unit 3. For example, when two target positions Pa (xa, ya, za) and Pb (xb, yb, zb) are input, a combination of target angles (θa1, θa2) and (θa1', θa2') with respect to the target position Pa. Is output. The combination of the target angles (θb1, θb2) and (θb1', θb2') with respect to the target position Pb is output.

In some embodiments, the target position is entered as coordinates. In another embodiment, the target position is provided by the user by indicating the position directly on the tomographic image (eg, by touch or pointing device).

Since the calculation may be a general calculation of inverse kinematics, the description thereof will be omitted.

The interference analysis unit 3 finds an equation of a straight line 20 indicating the direction in which the needle-shaped instrument 10 is inserted from the combination of target angle inputs from the angle calculation unit 2. The interference analysis unit 3 then finds the distances between the straight lines to the various targets from the equations of the found straight lines.

For example, the interference analysis unit 3 finds the equations of the straight line La and the straight line La'from the combination of the target angles (θa1, θa2) and (θa1', θa2'), and finds the equations of the straight line Lb and the straight line Lb'at the target angle. It is found from the combination of (θb1, θb2) and (θb1', θb2').

The interference analysis unit 3 then selects the combination with the maximum distance between the straight lines from the four combinations La-Lb, La-Lb', La'-Lb, and La'-Lb'. In this embodiment, La-Lb is selected. The selected combination of target angles is presented on the presentation portion 4.

The presentation portion 4 may be, for example, a display unit such as a monitor, which may be incorporated within the display of the medical image. Alternatively, the presentation portion may be, for example, a small display placed on the device.

At this time, since the calculation performed by the interference analysis unit 3 is a general calculation for finding the distance between two straight lines in the three-dimensional space, detailed description thereof will be omitted.

The user arbitrarily confirms the target angle presented on the presentation portion 4, so that the first rotation element 11 in FIG. 1 and the second rotation element 12 in FIG. 1 have the presented target angle. Rotate manually. At this time, the user manually changes the positions of the first rotating element 11 and the second rotating element 12 by referring to the position detecting units 6a and 6b provided on the rotating elements 11 and 12. In an alternative embodiment, the positioning of the rotating elements 11 and 12 is automated and the presentation portion is optional.

As a result, the needle guide 13 faces the target position Pa. By inserting the needle-shaped instrument 10a along the notch of the needle guide 13 in this posture, the instrument can be inserted at the target position Pa as shown in FIG. 5 (a).

Next, in order to puncture the target position Pb, the rotating elements 11 and 12 become the target angles θb1 and θb2 of the movable portion of the rotating element, similarly to the target position Pa, with the instrument 10a inserted. Will be moved.

As a result, the needle guide 13 faces the target position Pb. By inserting the needle-shaped instrument 10b along the notch of the needle guide 13 in this posture, the instrument can be inserted into the target position Pb.

Therefore, as shown in FIG. 5 (b), the needle-shaped instrument 10 is inserted into both the target position Pa and the target position Pb.

FIG. 9 shows an example of the hardware of the computing unit 100. The processor 101 reads and executes the program code stored in the hard disk device 103 to execute various types of processes and controls. The ram 102 temporarily stores information such as a program code executed by the processor 101. The hard disk device 103 stores a program code and various types of dates for performing the process and / or operation described by FIG. 8B above. The input device interface 104 accepts user input to the computer unit 100 from an input device 200 such as a keyboard, mouse, joystick, or touchpad. The output device interface 105 outputs data to output devices such as displays and recording devices. Peripheral interface 106 performs data and / or signal communication with an external device (eg, mechanical part 1).

In this way, in a puncture-assisting medical support device that has two rotating elements, when the device is inserted into a plurality of different target positions, the device can be inserted into those target positions without interfering with each other. can.

In this way, in a puncture-assisting medical support device that has two rotating elements, when the device is inserted into a plurality of different target positions, the device can be inserted into those target positions without interfering with each other. can.

The mechanical portion 1 can be fixed to the object with a tape, an adhesive or the like. The base 15 can be provided with a portion to which a belt-shaped instrument is attached, and the mechanical portion 1 can be fixed to an object by a belt or the like. If the mechanical portion 1 can be bolted to the object, the base 15 may be provided with holes for inserting bolts or other fixing elements into the base 15.

The rotating element does not necessarily have to be annular (ring-shaped) and arc-shaped, and may be a mechanism having two orthogonal rotation axes.

The position detection unit 6 does not necessarily have to be in the form of a scale, and may be an optical or electric detector such as an encoder or a potentiometer. In this case, the current angle may be displayed on the presentation unit 4, etc.

In these embodiments, the movable portion of the first rotating element 11 can rotate at ± 180 degrees. However, the present invention is not limited to this. The present invention can be applied even when the rotation angle is less than ± 180 degrees such as ± 145 degrees, ± 90 degrees, or ± 45 degrees.

The range of movement of the movable portion of the second rotating element 12 can be widened. As the range of movement increases, so does the range of puncture from the same installation position. However, in the present invention, this range is not limited as long as the puncture target position is within the range.

The shape of the needle guide 13 does not necessarily have to be a notch such as a triangular notch as shown in FIGS. 3 and 4, for example, a tubular shape, a cylindrical shape, a trough shape, or two parts in between. It may be shaped to hold (eg, two triangular, rectangular, or semicircular cutouts that make up two parts of a needle guide that is held or hinged to each other).

In some embodiments, for the sake of simplicity, only the case where only the needle guide 13b is used is described. However, the place near the base point cannot be punctured only by the needle guide 13b. In such a case, the needle guide 13b is replaced with the needle guide 13a to enable puncture in the vicinity of the base point.

In this embodiment, two types of needle guides 13 are shown, but the present invention uses, but is not limited to, three, four, five, or more needle guides 13 at different angles. can do. In some embodiments, the needle guide 13 is tilted in a plane in which the second rotating element 12 rotates. However, the present invention is not limited to this, as long as a straight line indicating the guiding direction does not pass through the intersection 23 of the rotation axes of the two rotating elements, and the needle guide 13 may be tilted in another direction or translated. May be done.

The needle guide 13 has a mechanism having a degree of freedom such as those shown in FIGS. 10 (a) to 10 (c), FIGS. 11 (a) to 11 (c), and FIGS. 12 (a) to 12 (c). This allows the direction and angle of the puncture to be freely changed.

10 (a), 11 (a) and 12 (a) are front views, FIGS. 10 (b), 11 (b) and 12 (b) are plan views, and FIGS. 10 (c) and 11 (b). c) and 12 (c) are side views. The needle guide 13 is attached to the movable portion 12b of the second rotating element 12 and can be moved only with a predetermined degree of freedom by the groove 130 and the fixing screw 131 provided in the direction of the degree of freedom. By tightening the fixing screw 131, the needle guide 13 can be fixed at the set angle.

FIG. 10 shows an example of a configuration that achieves a degree of freedom around a rotation axis parallel to the rotation axis of the second rotation element. FIG. 11 shows an example of a configuration that achieves a degree of freedom around a rotation axis perpendicular to the rotation axis of the second rotation element. FIG. 12 shows an example of a configuration that enables the needle guide 13 to be translated in the direction of the rotation axis of the second rotating element without changing the puncture direction.

The mechanisms of the needle guides 13 shown in FIGS. 10 (a) to 10 (c), FIGS. 11 (a) to 11 (c), and FIGS. 12 (a) to 12 (c) are described independently of each other. These may be combined, or a mechanism having a different configuration may be provided to achieve the same degree of freedom.

In some embodiments, only one combination determined by the interference analysis unit 3 is presented on the presentation portion 4. However, the present invention is not limited to this. For example, it is possible to present four combinations of straight lines and the distance between the two straight lines in each combination, whereby the user can select the combination to be used. Preferably, the combination that causes interference is avoided.

The number of puncture target positions is two. However, the present invention is not limited to this. The number of puncture target positions may be 3, 4, 5, or more. In this case, the number of combinations processed in the interference analysis unit 3 is 2 to the nth root, in which case n is the number of targets.

The greater the target position, the greater the likelihood of interference between instruments. Thus, one or more of the needle guides 13 may be configured to point the needle further away from the origin, or the plurality of needle guides 13 may be oriented in different directions so that they can be exchanged. It can be configured to face.

Second Embodiment Configuration The second embodiment of the present invention will be described with reference to FIGS. 6 to 8A. First, the schematic configuration of the mechanical portion of the medical support device of this embodiment will be described with reference to FIGS. 6 and 7.

Mechanical Configuration In FIG. 6, the structure of the movable portion within each rotating element is omitted for simplicity. Embodiments of rotating elements as described in US Patent Application Publication No. 2014/029799 are incorporated herein by reference. In use, the base 15 of the mechanical portion 1 is first fixed and attached by a fixation unit (not shown) onto the object to be punctured. This includes, for example, the patient's torso.

FIG. 7 is a cross-sectional view of the configuration of FIG. 6 cut along the ZY plane.

The mounting portion of the annular or ring-shaped first rotating element 11 is attached to the fixing unit.

The mounting portion of the annular second rotating element 12 has a support portion 14 attached between them to a movable portion of the rotating element 11. In the rotating element 11 and the rotating element 12, the rotating shaft 22 of the movable portion of the second rotating element 12 is tilted at a predetermined angle α with respect to the rotating shaft 21 of the movable portion of the first rotating element 11. And is configured to intersect this axis at the base point of the XYZ coordinates.

The needle guide 13 (not shown) is attached to a movable portion of the second rotating element 12. As in the first embodiment, the needle guide 13 has a notch. By inserting the needle-shaped instrument 10 along the notch, the insertion direction of the instrument 10 is guided. The straight line 20 indicates the direction in which the needle guide 13 guides the needle-shaped instrument 10 in this embodiment.

As shown in the block diagram of FIG. 8B, the first rotating element 11 and the second rotating element 12 are provided with position detecting units 6a and 6b, and the position detecting unit detects the rotation angle of each rotating element. can do. The position detection units 6a and 6b output signals indicating the rotation angles of the rotation elements 11 and 12. The signal outputs from the position detection units 6a and 6b are input to the control portions 5a and 5b.

The first rotating element 11 is connected to a drive source 7a provided on the base by a transmission mechanism (not shown), and the movable portion is driven by the drive source 7a. Similarly, the second rotating element 12 is connected to a drive source 7b provided on the support portion 14 by a transmission mechanism (not shown), and the movable portion is driven by the drive source 7b.

In some embodiments, the marker 30 is attached to the medical support device. Accordingly, some embodiments include at least three markers 30 that are imaged by MRI, CT or both MRI and CT and attached to mechanical portion 1. In some embodiments, four, five, or more markers 30 are attached.

System Configuration and Operation Next, the system in this embodiment will be described with reference to the block diagram of FIG. Here, the hard disk device 103 of FIG. 9 stores a program code and various types of dates for performing the process and / or operation described with reference to FIG. 8A below.

First, a tomographic image of the mechanical part 1 placed on the object is obtained by MRI or CT. The coordinate conversion unit 8 detects a plurality of markers 30 mounted on the mechanical portion 1 or installed in another form from the tomographic image, and based on this medical image, the machine is based on the positional relationship between the plurality of markers 30. Calculate the installation position and posture of the target part 1. The user specifies multiple target positions on the tomographic image. These positions are transmitted to the computing unit 100, which includes a coordinate conversion unit 8, an angle calculation unit 2, an interference analysis unit 3, and one or more control portions 5a and 5b.

The coordinate conversion unit 8 converts a plurality of target positions specified on the tomographic image into a plurality of target positions in the coordinate system of the mechanical part 1 based on the calculated installation position and posture of the mechanical part 1. , These are output to the angle calculation unit 2.

The angle calculation unit 2 finds two combinations of the target angles of the two rotating elements for each input target position, and outputs these to the interference analysis unit 3. For example, when two target positions Pa (xa, ya, za) and Pb (xb, yb, zb) are input, a combination of target angles (θa1, θa2) and (θa1', θa2') with respect to the target position Pa. Is output. The combination of the target angles (θb1, θb2) and (θb1', θb2') with respect to the target position Pb is output.

The interference analysis unit 3 finds an equation of a straight line 20 indicating the direction in which the needle-shaped instrument 10 is inserted from a combination of target angle inputs from the angle calculation unit 2. The interference analysis unit 3 then finds the distance between the straight lines to different targets from the equation of the found straight line.

For example, the interference analysis unit 3 finds the equations of the straight line La and the straight line La'from the combination of the target angles (θa1, θa2) and (θa1', θa2'), and finds the equations of the straight line Lb and the straight line Lb'at the target angle. It is found from the combination of (θb1, θb2) and (θb1', θb2').
The interference analysis unit 3 then selects the combination with the maximum distance between the straight lines from the four combinations La-Lb, La-Lb', La'-Lb, and La'-Lb'. In this embodiment, La-Lb is selected as the combination with the largest distance between the straight lines. The maximum distance is chosen to minimize possible interference. In other embodiments, it is not necessary to select the combination with the greatest distance.

In this embodiment, the interference analysis unit 3 outputs the target angle θa1 to the control portion 5a which is the control portion of the first rotation element 11. In addition, the interference analysis unit 3 outputs the target angle θb1 to the control portion 5b, which is the control portion of the second rotating element 12.

The control portion 5a is driven by a drive source 7a provided on the first rotating element 11 based on the input of the target angle θa1 from the interference analysis unit 3 and the position detecting unit 6a attached to the first rotating element 11. By outputting a command, the position of the movable portion of the first rotating element 11 is controlled. Specifically, the control unit 5a outputs a drive command based on the difference between the current angle obtained from the position detection unit 6a and the target angle θa1, and controls so as to reach the target angle θa1. ..

Similarly, the control portion 5b is driven by the drive source 7b provided in the second rotating element 12 based on the signal obtained from the target angle θb1 and the position detecting unit 6b attached to the second rotating element 12. By outputting a command, the position of the movable portion of the second rotating element 12 is controlled.

Alternatively, instead of outputting the drive command to the control portion of the rotating element, the interference analysis unit 3 can output the rotational position of the rotating element and then allow manual adjustment of the rotating element. Alternatively, the interference analysis unit 3 can output both a drive command and a rotation position to trigger the rotation of the rotating element, thereby allowing the user to verify automatic rotation.

As a result, the needle guide 13 faces the target position Pa. By inserting the needle-shaped instrument 10a along the notch of the needle guide 13 in this posture, the instrument can be inserted at the target position Pa.

Next, in order to puncture the target position Pb, the drive sources 7a and 7b are driven so that the rotating elements 11 and 12 are at their target angles θb1 and θb2, with the instrument 10a still inserted. As a result, the needle guide 13 faces the target position Pb. By inserting the needle-shaped instrument 10b along the notch of the needle guide 13 in this posture, the instrument 10b can be inserted into the target position Pb without interfering with the instrument 10a.

Third Embodiment A third embodiment of the present invention will be described with reference to FIGS. 13 to 14. First, a device using interchangeable needle guides of different designs will be described with reference to FIG. However, needle guides as described in the first and second embodiments can also be combined with the teachings of this embodiment.

FIG. 13 presents an example of a removable needle guide device. For simplicity, only two facing faces 24 and 25 are shown. When combined, these surfaces form a second rotating element 12, for example as described in FIG. The lower facing surface 24 is attached to a first rotating element or base (not shown).

The needle guide can be attached and detached at the user's will. For example, the needle guide can be slid in and out of the groove onto a pin-like structure, or it can include a snap closure for fixing and removing from the device. The removable facing surface 25 of the rotating element 12 includes a needle guide 13. The removable mating surface of the needle guide 25 can be mounted in a safe position by pushing the boss 26 at the top of the lower mating surface 24 into the hole 27 on the upper facing surface of the needle guide 25. Can be removed from.

Each needle guide 13 can have a unique shape so that the needle-shaped instrument 10 can be inserted without colliding with the previously inserted needle.

In one exemplary embodiment, the notches on each needle guide may be formed such that they rest at different heights. It guides the needle to an inlet point above or below the intersection of the axes of rotation of the two rotating elements 11 and 12. In FIG. 14, two needle guides 13 and 13b of different heights are overlapped. In this figure, this example shows the difference where the guide 13 intersects the rotating shaft 21 of the lower ring.

Fourth Embodiment In the fourth embodiment of the present invention, a system using a unique and preset needle guide for each inserted needle will be described with reference to FIGS. 15A-15C.

During the insertion of multiple needles, each needle guide can be used in a predetermined order. These needle guides can be redesigned to ensure that each needle has its own insertion path and does not interfere with earlier or later needles.

The user can determine which needle guide to use by the marking on the needle guide unique to each design.

The marking can include numbers, letters, colors, or names, or any variation or combination thereof. FIG. 15 shows an example of three differently designed needle guides, each of which has its own marking for identification.

Procedure The workflow or software can teach the user the order in which they should be used.

The software can modify the kinematics algorithm to suit the unique design of each needle guide.

The user 19 selects the first needle guide 13 as shown in the workflow and attaches it to the second rotating element 12. The user 19 sends the target to the control device by software, and the robot rotates the rotating element to align the first needle guide with the target. User 19 then inserts the needle into the guide until it reaches the target. After the needle reaches the target, the user 19 removes the first needle guide 13 from the second rotating element 12 and discards it. The user 19 then takes a second needle guide 13 as shown by the workflow and attaches it to the second rotating element 12. The user 19 sends the target to the control device by software, and the robot rotates the rotating element to align the second needle guide with the target. The software already knows the order in which the needle guides are used, so the user does not need to change any settings in the software. The user inserts the needle and repeats this process until all the needles are indwelling.

Fifth Embodiment A fifth embodiment of the present invention will be described with reference to FIGS. 16 to 17.

First, a system using a user-selected needle guide for each inserted needle will be described.

During the insertion of multiple needles, the user can determine which needle guide to use so that the next needle insertion will not collide with the previously inserted needle. Alternatively, the needle guides can be provided in the kit in a predetermined order, in which case each of the needle guides, when used in order, does not require movement of the patient's skin or anterior needle. , Do not collide with each other.

The device and associated software can detect which needle guide is inserted and update the kinematics algorithm to match the current guide.

Next, a system for sensing which needle guide design is used for each inserted needle will be described with reference to FIGS. 16 to 17.

FIG. 16 shows an example of a needle guide used in a system where needle guide identification is sensed using the key design 28. For simplicity, only the needle guide and key 28 are shown. In this design, various pins are pushed down according to the shape of the key 28 attached to the needle guide. The identification of the needle guide can be deciphered based on the combination of pins to be pressed.

FIG. 17 shows an example of a system in which the optical sensor 29 detects a unique marking on the needle guide to identify what is being used. For simplicity, only markings are shown. In this design, the visual markings are detected by the optical sensor 29 and the software can determine which needle guide design matches the detected markings.

In other embodiments, other methods of determining which needle guide to provide on the medical support device may be used. These methods can include other types of sensors, pins, or other structures that can provide information to the kinematics algorithm to specify the insertion of a needle with a unique holder.

Sixth Embodiment As shown in FIG. 18, there is a pivot point 30, which reaches all target positions within the reachable volume 32 when the needle guide 13 is used. This is what a needle or other needle-like device must pass through. The needle reachable volume 32 is a conical volume, where the tip of the cone is located at the pivot point 30 and extends within the patient. The pivot point 30 may be located within several locations relative to the patient's skin 34. For example, the pivot point 30 can be above the skin 34, on the skin 34, or within the patient. This can be specified by the design of the medical support device, optionally by any other device or component worn on the patient. For example, the device can move the pivot point above the surface of the skin by adding an RF coil under the medical support device that initially has the pivot point on the skin. If the pivot point 30 coincides with a location on the patient's skin 34 (as shown in FIG. 18) or within the patient, this interferes with accurate targeting when using multiple needles with the needle guide 13. Since the anterior needle will pass through the pivot point 30, each course must be modified to move around the anterior needle for insertion. The pivot point 30 can also be offset from the intersection 23. When the pivot point 30 is located above the patient, the desired course of the plurality of needles through the pivot point can be maintained without overlapping needles even when using the plurality of needles. .. For example, after the first needle is indwelled, the user 19 can tilt the first needle and shift the needle while inserting the next needle. Since the first needle is already placed in the patient, the tip is stationary and only the portion of the needle that remains outside the patient bends away from the pivot point 30.

Discussion of Height Change In the next embodiment, as shown in FIG. 18B, the medical support device has a remote movement center (RCM) that is placed above the subject when placed in the subject. The height of the needle guide is changed, thus changing the pivot point 30 of the needle. As shown in FIG. 18B, if the same angle is maintained and the height is shifted upward in the Y direction, the pivot point 30 shifts upward. This shift has multiple effects. One effect is a shift at the first puncture point 36 due to a shift at the first course 38. A new puncture point 40 is created after the course 42. For example, if the pivot point 30 is originally on the surface of the skin and then the pivot point 30 is shifted upwards, the first puncture point 36 is shifted outwards. Another effect is the change in reachable volume 32 when assuming a fixed needle length. By changing the pivot point, the reachable volume 32 is shifted. Therefore, in use, the first needle-like device is inserted at the first puncture starting point and then the medical assistance device (or part of the medical assistance device) moves upwards away from the patient's skin. Will be done. Next, the second needle-shaped instrument is inserted into a second puncture start point different from the first puncture start point.

Angle change discussion In embodiments where the angle of the needle guide is changed, there are multiple effects. These effects are similar to changing the height of the needle guide as described in the previous embodiment. If the height is maintained, the angle shift creates a new puncture point. For example, in FIG. 18C, θ represents the original angle of the first course 38 with respect to the surface of the skin 34 as the needle enters the skin at the first puncture start point 36, and Φ changes the needle guide angle. Represents the angle between the second course 42 and the skin 34 created thereby. By changing the angle, instead of entering the patient at the first puncture start point 36, the entrance point is shifted upwards to the second puncture start point 44. Another effect can be seen when the needle length is maintained. The conical shape representing the reachable volume 32 of the needle is modified. Having an angle θ, the cone becomes narrower and can reach deeper beyond the surface. With an angle Φ, the cone becomes wider and reaches a shallower volume. Therefore, in use, the first needle-like instrument is inserted at the first puncture starting point where the needle guide holds the needle at an angle θ. The second needle-like instrument is inserted by a second needle guide that holds the needle at an angle φ. The second needle is inserted into a second puncture start point that is different from the first puncture start point.

Combination of angle change and height change of needle guide

As a result of the combination of changing the height and angle of the needle guide 13, the effects of each individual change are combined. For example, the pivot point 30 can be maintained while changing the shape of the reachable volume of the needle by combining the effects of changing the needle guide height and angle.

Example: Calculation In the configuration of this example, the inclination α of the second rotating element is set to 20 degrees, and the diameter of the needle-shaped instrument 10 is set to 2 mm. The first position of the first rotation element 11 is set so that the second rotation axis 22 is in the YZ plane. The first position of the second rotating element 12 coincides with the Y axis when the needle guide 13 intersects the intersection 23 of the rotating axis (different from the needle guide in this description) and indicates the guiding direction. Is set to. The straight line indicating the guide direction of the needle guide 13 is a straight line passing through two points (0 mm, 50 mm, 0 mm) and (5 mm, 0 mm, 0 mm) on the XYZ coordinates when the mechanical portion 1 is in the initial position. Is set to. This straight line is represented by the following equation (1) using the parameter t.

The two target positions Pa (xa, ya, za) and Pb (xb, yb, zb) are set to Pa (10 mm, -50 mm, 20 mm) and Pb (-5 mm, -40 mm, 10 mm).

When the target position Pa is input to the angle calculation unit 2, the following combination of the target angles of the two rotating elements is output:
(Θa1 = -91.11 degrees, θa2 = 40.23 degrees)
(Θa1'= 144.24 degrees, θa2'= -99.09 degrees)

Similarly, when the target position Pb is input to the angle calculation unit 2, the following combination of the target angles of the two rotating elements is output.
(Θb1 = -124.11 degrees, θb2 = 8.87 degrees)
(Θb1'= 70.98 degrees, θb2'= -75.17 degrees)

Next, the interference analysis unit 3 finds straight lines La, La', Lb, and Lb' indicating the guiding direction of the needle guide 13 in each posture from the configuration of the mechanical portion 1 and the input combination of the target angles of the rotating elements. ..

The interference analysis unit 3 then finds the distance between the two straight lines in each of the four possible combinations La-Lb, La-Lb', La'-Lb, and La'-Lb'. In this example, the distance between the two straight lines for each combination is as follows.
La-Lb: 3.65 mm
La-Lb': 4.45 mm
La'-Lb: 8.93 mm
La'-Lb': 2.28 mm

In this embodiment, the combination with the largest distance between the two straight lines is selected. Therefore, La'-Lb is selected. Based on this, the drive sources 7a and 7b drive the rotating element towards the target angle.

Since the diameter of the instrument 10 is set to 2 mm, even if this diameter is taken into account, the two needle-shaped instruments 10a and 10b are 6.93 mm away from each other, even if they are closest to each other. Therefore, they can puncture their respective target positions without interfering with each other.

In this embodiment, the angle calculation unit 2, the interference analysis unit 3, and the control unit 5 are described as separate units. However, this is a conceptual separation. For example, these units can be simultaneously incorporated into the CPU as a component of software. Alternatively, a single software program can perform multiple functions. In some embodiments, one or more of the angle calculation unit 2, the interference analysis unit 3, and the control unit 5 is a dedicated part of the firmware.

In the embodiment described above, the number of puncture target positions is two. However, the present invention is not limited to this. The number of puncture target positions may be 3, 4, 5, or more. As more needles are used, the likelihood of interference between different instruments increases. Therefore, the needle guide 13 can be directed to a point further away from the base point, or a plurality of needle guides 13 pointing in different directions can be prepared. Thus, when only a few needles need to be placed, a needle holder with needle guides 13 that are slightly different in orientation from the intersection of the axes of rotation of the two rotating elements can be used, with more needles in the procedure. When indicated, it is contemplated that a needle guide with a greater orientation difference will be used. The needle placement device can include multiple interchangeable needle guides that are different to accommodate the differences required for deflection.

The plurality of needle guides 13 facing a plurality of directions are interchangeable, but the present invention is not limited thereto. For example, needle guides pointing in different directions can be provided at 0 and 180 degree positions of the movable portion of the second rotating element, and the needle guide to be used is selected based on the analysis result of the interference analysis unit 3. be able to.

The needle guide 13 is shown in FIGS. 10 (a) to 10 (c), FIGS. 11 (a) to 11 (c), and FIGS. 12 (a) to 12 (c), as in the first embodiment. It is possible to have a mechanism having a degree of freedom of the above, whereby the puncture direction can be freely changed.

The marker 30 is disposed on the base 15 as shown in FIG. 6 in this embodiment, but the present invention is not limited to this, and the marker 30 is placed on the first rotating element 11 or the second rotating element 12. It may be arranged in. In this case, it may be necessary to detect the angle of each rotating element and record the position of each marker 30 in the coordinate system of the assisting device. In other embodiments, markers can be used to identify types such as needles, diameters, cryos, radios, reference heights for needle insertion, and the like.

In this embodiment, the rotating elements 11 and 12 and the drive sources 7a and 7b are connected by a transmission mechanism. The transmission mechanism can be constructed using, for example, gears or timing belts.

The medical support device is designed to be placed on the patient. Thus, in use in some embodiments, the first needle-like instrument is guided by a needle guide and at a predetermined angle within the patient having a predetermined first puncture starting point at which the needle punctures the patient's skin. Will be inserted into.

In one example of an embodiment of the invention, the medical support device is placed above the patient's liver. MRI images are obtained while the medical assistance device is attached to the patient. The insertion trajectory is planned using the first MRI image. The scheme can include selecting different locations within the liver lesion for radiofrequency ablation, for example, by touching a location point on a touch screen showing an MRI image. The coordinate transformation unit converts these positions on the image to target positions in the coordinate system. The angle calculation unit 2 then calculates a combination of target angles of the two rotating elements that provide the correct needle insertion parameter for each input target position and outputs this parameter to the interference analysis unit 3. The medical support device is then instructed to move the needle device guide to the first position. This probe location can be confirmed by intra-procedural images. The user can then locate and insert the needle-like device into the patient's liver. Optionally, the needle-like device may be partially inserted and a confirmation image can be obtained prior to inserting the entire needle-like device.

Embodiments of the invention also read and execute computer-executable instructions (eg, one or more programs) recorded on a storage medium (which may also be more completely referred to as a "fixed computer readable storage medium"). And / or one or more circuits (eg, specific) for performing one or more functions of the embodiments described above and / or performing one or more functions of the embodiments described above. One of embodiments described above, wherein a computer-executable instruction is read from a storage medium and executed by a computer of the system or apparatus, including an integrated circuit for application (ASIC), and by a computer of the system or apparatus, for example. It can be achieved by a method performed by performing one or more functions and / or controlling one or more circuits to perform one or more functions of the embodiments described above. A computer can include one or more processors (eg, a central processing unit (CPU), a microprocessing unit (MPU)), including a separate computer or a network of separate processors to read computer executable instructions. , Can be executed. Computer-executable instructions can be provided to the computer, for example, from a network or storage medium. The storage medium may be, for example, a hard disk, random access memory (RAM), read-only memory (ROM), storage device for distributed computing systems, optical discs (compact discs (CDs), digital multipurpose discs (DVDs), or Blu-ray discs (Blu-ray discs). BD) (trademark), etc.), flash memory devices, memory cards, etc. can be included.

When referring to the description, specific details are provided to provide a complete understanding of the disclosed examples. In other cases, well-known methods, procedures, components, and circuits are not described in detail so as not to lengthen the disclosure unnecessarily.

An exemplary embodiment is described below with reference to some figures, but here the same reference numbers indicate the same or corresponding portions throughout the plurality of figures and embodiments. Therefore, the description of such parts with the same reference number is not repeated for multiple figures.

When an element or part is indicated herein to be "on", "contact", "connected", or "combined" with another element or part, this is direct. It should be understood that it is possible to be tangentially connected, connected or combined, or that an intervention element or part may be present on, in contact with, connected or combined with another element or part. In contrast, an element is shown to be "directly on" another element or part, "directly linked" to another element or part, or "directly combined". If there is no intervention element or part. The term "and / or", when used, includes any combination of any one or more of the articles listed in connection, if provided.

To facilitate explanations for explaining the feature relationship with one element or another element or feature exemplified in the various figures, "below", "below", "below", "below", " Spatial relative terms such as "upper", "upper", "proximal", and "distal" can be used herein. However, it should be understood that spatial relative terms are intended to include various orientations of the device in use and operation, in addition to the orientations shown in the figure. For example, if the device in the figure is flipped, the "down" or "down" of the other element or feature is oriented "above" the other element or feature. Thus, relative spatial terms such as "downward" can include both upward and downward orientations. The device may be otherwise oriented (rotated at 90 degrees or in any other orientation) and the spatial relative descriptors used herein are to be construed accordingly. Similarly, the relative spatial terms "proximal" and "distal" can also be interchangeable, if applicable.

As used herein, the term "about" or "almost" means within the acceptable range of a particular parameter specified by one of ordinary skill in the art, which means how its value is. It was measured or determined, for example, due in part to the limitations of the sample preparation and measurement system. For example, "about" means a range up to 20%, more preferably up to 10% of a given value.

The terms first, second, third, etc. may be used herein to describe various elements, components, areas, parts and / or sections. It should be understood that these elements, components, areas, parts, and / or sections should not be limited by these terms. These terms are used only to distinguish one element, component, area, part, or section from another area, part, or section. Accordingly, the first element, component, area, part, or section discussed below may be referred to as a second element, component, area, part, or section without departing from the teachings herein. ..

The terminology used herein is for illustration purposes only and is not intended to be limiting. As used herein, the singular forms "one (a)", "one (an)" and "that" are intended to include the plural unless the content is expressly stated otherwise. The terms "contains" and / or "contains", as used herein, express, but expressly, the existence of the features, integers, steps, actions, elements, and / or components described. It should be further understood that it does not preclude the existence or addition of one or more other features, integers, steps, actions, elements, components and / or groups thereof that are not mentioned.

Specific terminology is used to clarify when describing the exemplary embodiments illustrated in the figures. However, the disclosure of this patent specification is not intended to be limited to the specific terminology so selected, with all technical equivalents in which each specific element operates in a similar manner. Please understand that it includes. It is clear that variants and modifications of the invention can be added without departing from the spirit or scope of the invention. Further review of the specification will reveal to those skilled in the art another aspect, purpose, and advantage of the invention.

Although the above description provides examples and specific details of various embodiments, some features and / or functions of the embodiments described will lead to modifications without departing from the scope of the embodiments described. Will be understood. The above description is intended to illustrate the invention, the scope of which is limited only by the language of the claims herein. The claims shall follow the broadest interpretation to include all such modifications and equivalent structures and functions.

Claims (16)

A medical support device
A first rotating element having a first axis of rotation and a first degree of freedom of rotation,
A second rotation element attached to the first rotation element having a second rotation axis and a second degree of freedom, wherein the second rotation axis intersects the first rotation axis. The second rotating element and
It comprises a first needle guide and a second needle guide that can be attached to the second rotating element simultaneously or sequentially and are configured to guide the direction of insertion of the needle-like instrument.
After the first needle guide guides the first needle-shaped device, the second needle-shaped device is guided by the second needle guide whose height or angle is different from that of the first needle-shaped device. By guiding the above, the first needle does not come into contact with the second needle-shaped instrument, and the attachment position of the second needle guide on the second rotating element is set to the first needle. Medical treatment that can guide both the first needle-shaped device and the second needle-shaped device to be in the inserted state without changing the mounting position of the guide in the second rotating element. Assistance device. The medical support device according to claim 1 , wherein each of the first needle guide and the second needle guide has a visible or electronic identification marker that distinguishes the needle guide. The guide angle is different from the guide of the first needle-shaped instrument. By guiding the second needle-shaped instrument by the second needle guide, the first puncture through which the first needle-shaped instrument passes. The medical support device according to claim 1, wherein the starting point and the second puncture starting point through which the second needle-shaped instrument passes are different. The guide height is different from the guide of the first needle-shaped device. By guiding the second needle-shaped device by the second needle guide, the first needle-shaped device passes through the first needle-shaped device. The medical support device according to claim 1, wherein the puncture start point and the second puncture start point through which the second needle-shaped instrument passes are different. To determine the possible angles of the two rotating elements, the first rotating element and the second rotating element, based on the designated target position and the placement of the two rotating elements and the first needle guide. The medical support device according to claim 1, further comprising an angle calculation unit configured in 1. The interference analysis unit is the possible angle of the two rotating elements with respect to each target position found by the angle calculation unit with a plurality of straight lines indicating the insertion direction with respect to the specified target positions. To determine the combination of insertion directions in which the plurality of needles do not contact each other, such that the distance between the plurality of straight lines is greater than or equal to the diameter of the needles used. The medical support device according to claim 5 , further comprising an analysis unit. The interference analysis unit selects the combination of the insertion directions having the largest distance between the straight lines, or any one combination, from the combinations of the plurality of insertion directions in which the plurality of needle-shaped instruments do not come into contact with each other. The medical support device according to claim 6 . The medical support device according to claim 6 or 7 , further comprising a presentation unit configured to present the combination of the plurality of insertion directions without contact between the plurality of needle-shaped instruments. The medical support device comprises the first needle guide and the second needle guide pointing in different directions at the same time, and one of the first needle guide and the second needle guide pointing in different directions is said. The two rotating elements are oriented so as to pass through the intersection of the axes of rotation, the other so that the distance from the intersection is greater than or equal to the diameter of the needle-like device used. The medical support device according to claim 5 . One of claims 1 to 9 , wherein the first needle guide has a degree of freedom, and the first needle guide is configured to change the direction in which the needle-shaped instrument is guided. The medical support device described in. The medical support device according to any one of claims 1 to 10 , wherein the first needle guide is configured to separate the needle-shaped instrument after insertion. The medical support device according to any one of claims 1 to 11 , wherein each of the first rotating element and the two rotating elements of the second rotating element has a position detecting unit. At least one of the two rotating elements has a drive unit, and each rotating element is found by the angle calculation unit and up to the angle selected by the interference analysis unit based on the position information obtained by the position detection unit. The medical support device according to claim 12 , which is moved. The medical support device according to any one of claims 1 to 13 , further comprising a medical image pickup device and at least three markers that can be imaged by the medical image pickup device. A medical support device
With at least one rotatable part having at least one degree of freedom of rotation,
At least one needle guide attached to the rotatable portion,
(A) Guide the insertion direction of at least two needle-shaped instruments,
(B) Provided with a needle guide configured to separate from the needle-shaped instrument after insertion of the needle-shaped instrument.
The needle guide is configured to guide the first needle-like instrument to the first puncture start point when the needle guide is positioned at a first angle.
The needle guide guides the first needle-shaped device, separates the first needle-shaped device from the needle guide while the first needle-shaped device is inserted, and then separates the first needle-shaped device from the needle guide. Is positioned at a second angle where the first angle and the angle for guiding the needle-shaped device are different, the second needle-shaped device is placed on the second puncture start point different from the first puncture start point. It is configured to guide you to a point,
The needle guide is the first needle without the first needle-shaped instrument coming into contact with the second needle-shaped instrument and without changing the mounting position of the needle guide in the rotatable portion. A medical support device capable of guiding both the shape instrument and the second needle-like instrument to be in the inserted state. The medical support device according to claim 15 , wherein the needle-shaped instrument is configured to separate from the needle guide by exiting a notch in the needle guide.

Images