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WO2017010992A1 - Dispositif de support médical - Google Patents

Dispositif de support médical Download PDF

Info

Publication number
WO2017010992A1
WO2017010992A1 PCT/US2015/040336 US2015040336W WO2017010992A1 WO 2017010992 A1 WO2017010992 A1 WO 2017010992A1 US 2015040336 W US2015040336 W US 2015040336W WO 2017010992 A1 WO2017010992 A1 WO 2017010992A1
Authority
WO
WIPO (PCT)
Prior art keywords
needle
support device
guide
medical support
instrument
Prior art date
Legal status (The legal status is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the status listed.)
Ceased
Application number
PCT/US2015/040336
Other languages
English (en)
Inventor
Kazufumi Onuma
Takahisa Kato
Nobuhiko Hata
Kemal TUNCALI
Brian NINNI
Peter TIA
Current Assignee (The listed assignees may be inaccurate. Google has not performed a legal analysis and makes no representation or warranty as to the accuracy of the list.)
Brigham and Womens Hospital Inc
Canon USA Inc
Original Assignee
Brigham and Womens Hospital Inc
Canon USA Inc
Priority date (The priority date is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the date listed.)
Filing date
Publication date
Application filed by Brigham and Womens Hospital Inc, Canon USA Inc filed Critical Brigham and Womens Hospital Inc
Priority to JP2018501957A priority Critical patent/JP7030682B2/ja
Priority to PCT/US2015/040336 priority patent/WO2017010992A1/fr
Publication of WO2017010992A1 publication Critical patent/WO2017010992A1/fr
Anticipated expiration legal-status Critical
Ceased legal-status Critical Current

Links

Classifications

    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00—Surgical instruments, devices or methods
    • A61B17/34—Trocars; Puncturing needles
    • A61B17/3403—Needle locating or guiding means
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B90/00—Instruments, implements or accessories specially adapted for surgery or diagnosis and not covered by any of the groups A61B1/00 - A61B50/00, e.g. for luxation treatment or for protecting wound edges
    • A61B90/90—Identification means for patients or instruments, e.g. tags
    • A61B90/94—Identification means for patients or instruments, e.g. tags coded with symbols, e.g. text
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00—Surgical instruments, devices or methods
    • A61B2017/0046—Surgical instruments, devices or methods with a releasable handle; with handle and operating part separable
    • A61B2017/00464—Surgical instruments, devices or methods with a releasable handle; with handle and operating part separable for use with different instruments
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B90/00—Instruments, implements or accessories specially adapted for surgery or diagnosis and not covered by any of the groups A61B1/00 - A61B50/00, e.g. for luxation treatment or for protecting wound edges
    • A61B90/39—Markers, e.g. radio-opaque or breast lesions markers
    • A61B2090/3954—Markers, e.g. radio-opaque or breast lesions markers magnetic, e.g. NMR or MRI

Definitions

  • the present invention relates to a medical support device for holding and positioning a needle. More specifically, the present invention relates to positioning of one or more needles in a puncture treatment.
  • a marker attached to a device is recognized on a medical image, and the attitude of the device is found. On the basis of this attitude and the position of the puncture target, the direction and depth of puncture may be determined and puncture is supported.
  • this mechanism a needle can be inserted through the same insertion point toward different puncture targets, and therefore the trauma due to puncture is minimized.
  • the mechanism can be reduced in size, and a patient can enter an existing medical imaging machine with the device attached to them.
  • a medical support device comprises: a first rotational element having a first rotation axis and a first rotational degree of freedom; a second rotational element having a second rotation axis and a second rotational degree of freedom that is attached to the first rotational element wherein the second rotation axis intersects with the first rotation axis; and at least one needle guide that is attachable to the second rotational element and is configured to guide the direction of insertion of a needle-like instrument.
  • the at least one needle guide includes at least one guide portion that guides a first needle-like instrument through a first puncture starting point and guides a second needle-like instrument through a second puncture starting point which is different from the first puncture starting point, wherein, the at least one needle guide is in a first position when guiding the first needle-like instrument and in a second position when guiding the second needle-like instrument, or a first needle guide includes a first guide portion that guides a needle-like instrument through the first puncture starting point and a second needle guide includes a second guide portion that guides a needle-like instrument through the second puncture starting point.
  • a medical support device comprising: at least one rotatable portion having at least one rotational degree of freedom and at least one needle guide attached to the rotatable portion and having a guide portion, which is configured to: (a) guide the direction of insertion of a needle-like instrument and (b) separate from the needle-like instrument after insertion of the needle-like instrument, wherein the guide portion, when the needle guide is positioned in a first position, is configured to guide the needle-like instrument to a first puncture starting point wherein the guide portion, when the needle guide is positioned in a second position, or wherein the guide portion of a second needle guide is configured to guide the needle-like instrument to a second puncture starting point which is different from the first puncture starting point.
  • FIG. 1 For embodiments, Other embodiments provide a method comprising: attaching a medical support device to a patient, wherein the medical support device comprises a first rotational element, second rotational element, and at least two needle guides, defining at least a first location and a second location in the patient for therapeutic intervention based on an image data, attaching a first needle to a first needle guide, attaching the first needle guide to the medical support device, instructing the medical support device to rotate the first rotational element and the second rotational element to a position defined by the first location for therapeutic intervention, inserting the first needle into the patient, releasing the first needle from the medical support device, attaching a second needle to a second needle guide and attaching the second needle guide to the medical support device, instructing the medical support device to rotate the first rotational element and the second rotational element to a position defined by the second location for therapeutic intervention, inserting the second needle into the patient, wherein the second needle does not contact the first needle during insertion into the patient, and releasing the second needle from the medical support device.
  • Fig. 1 shows the schematic configuration of a mechanical portion of a first embodiment.
  • Fig. 2 shows the schematic configuration of the first embodiment.
  • Figs. 3A, 3B, and 3C show three views of a first example of a needle guide.
  • Fig. 3A is a front view.
  • Fig. 3B is a plan view.
  • Fig. 3C is a perspective view.
  • Figs. 4A, 4B, and 4C show three views of a second example of a needle guide.
  • Fig. 4A is a front view.
  • Fig. 4B is a plan view.
  • Fig. 4C is a perspective view.
  • Figs. 5A and 5B show the state of needles during puncture.
  • Fig. 6 shows the schematic configuration of a mechanical portion of a second embodiment.
  • Fig. 7 is a schematic sectional view of the mechanical portion of the second embodiment.
  • Fig. 8A is a block diagram of the second embodiment.
  • Fig. 8B is a block diagram of the first embodiment.
  • Fig. 9 is a block diagram of a computer system as described here.
  • Figs. IOA, IOB, and 10C show a first needle guide mechanism having a degree of freedom.
  • Figs. 11A, 11B, and 11C show three views of a second needle guide mechanism having a degree of freedom.
  • Fig. 11A is a front view.
  • Fig. 11B is a plan view.
  • Fig. 11C is a side view.
  • Figs. 12A, 12B, and 12C show three views of a third needle guide mechanism having a degree of freedom.
  • Fig. 12A is a front view.
  • Fig. 12B is a plan view.
  • Fig. 12C is a side view.
  • Fig. 13 shows the schematic configuration of a mechanical portion of a third embodiment.
  • Fig. 14 shows a cut away view of the schematic configuration of a mechanical portion of a third embodiment.
  • Fig. 15A - 15C each shows schematic configurations of a mechanical portion of a fourth embodiment.
  • Fig. 16 shows a cut away view of the schematic configuration of a mechanical portion of a fifth embodiment.
  • Fig. 17 shows a cut away view of the schematic configuration of a mechanical portion of a fifth embodiment.
  • Fig. 18A is a schematic showing the cone-shaped volume a needle-like instrument can pass through during rotation of the medical support device.
  • Fig. 18B is a schematic showing cone-shaped volume for two needle-like instruments where the height of the needle guides are different.
  • Fig. 18C is schematic showing cone-shaped volumes for two needle-like instruments where the angle of the needle guides are different.
  • FIG. 1 A first embodiment of the present invention will be described with reference to Fig. 1, Figs. 5A and 5B, and Fig. 6 to Fig. First, the schematic configuration of a mechanical portion of a medical support device of this embodiment will be described with reference to Fig. 1.
  • a base 15 of a mechanical portion 1 is fixed and installed on an object to be punctured with a fixing unit (not shown).
  • a stationary portion of an annular, or ring shaped first rotational element 11 (also defined as a rotation mechanism) is attached to the base 15.
  • a stationary portion of an arcuate second rotational element 12 (also defined as a rotation mechanism) is attached to a movable portion of the rotational element 11.
  • the rotational element 11 and the rotational element 12 are configured such that, as shown in Fig. 2, the rotation axis 22 of the second rotational element 12 that represents the center of rotation of a movable portion of the second rotational element 12 is perpendicular to the rotation axis 21 of the first rotational element 11 that represents the center of rotation of the movable portion of the first rotational element 11.
  • a needle guide 13 is attached to the movable portion of the second rotational element 12.
  • the needle guide 13 has a cutout. By inserting a needle-like instrument 10 along the cutout, the insertion direction of the instrument 10 is guided.
  • the first rotational element 11 and the second rotational element 12 are optionally provided with scale-like position detection units 6a and 6b, with which the rotation angle of each rotational element can be detected.
  • the medical support device is positioned on an object such as a human torso and the two rotational elements are rotated to define an optimal or predefined trajectory for a needle like element when inserted along the cut-out of the needle guide.
  • Fig. 2 the needle guide 13 and the position detection units 6a and 6b are omitted for simplification.
  • the needle-like instrument 10 is also omitted. Instead, a straight line 20 showing the direction of the instrument is depicted.
  • the XZ plane is defined as a plane containing the bottom surface of the mechanical portion
  • the Y-axis is defined as an axis perpendicular to the XY plane.
  • a coordinate (x, y, z) shows the values of the X-axis, Y-axis, and Z-axis.
  • the movable portion of the first rotational element 11 is arranged such that the rotation axis 21 is perpendicular to the bottom surface.
  • the movable portion of the first rotational element 11 is arranged such that the rotation axis 21 coincides with the Y-axis.
  • the movable portion of the first rotational element 11 is rotatable at least ⁇ 180 degrees.
  • the movable portion of the second rotational element 12 is arranged such that the rotation axis 22 is perpendicular to the rotation axis 21 of the first rotational element 11.
  • the movable portion of the second rotational element 12 is arranged such that the rotation axis 22 coincides with the Z-axis.
  • the rotation axis 22 is not fixed.
  • the rotation axis 22 is also rotated. For example, when the first rotational element 11 is rotated 90 degrees, the rotation axis 22 coincides with the X- axis.
  • Needle guides 13 facing in different directions as shown in Figs. 3A to 3C and Figs. 4A to 4C are interchangeable with each other.
  • several needle guides with the configuration of Fig. 3 and/ or Fig. 4 may be positioned on the needle guide.
  • Fig. 3A and Fig. 4A are front views
  • Fig. 3B and Fig. 4B are plan views
  • Fig. 3C and Fig. 4C are isometric views.
  • the needle guide 13b shown in Figs. 4A to 4C is provided with a cutout so as to guide a needle-like instrument 10 in a direction that does not pass through the intersection 23 of the rotation axis 21 of the first rotational element 11 and the rotation axis 22 of the second rotational element 12.
  • the needle guide 13a shown in Figs. 3A to 3C is provided with a cutout so as to guide a needle-like instrument 10 in a direction that passes through the intersection 23 of the two rotation axes.
  • the needle guides can be formed with a different angle for the cutout. This provides for needle guides that will guide a needle to an entry point having a different proximity to the intersection of the rotation axis of the two rotational elements.
  • the cutout of the needle guide is triangular in shape. In other embodiments the cutout is a semicircle, square, rectangular, or having some other shaped. In other embodiments, instead of a cutout as described herein, the needle guide 13 may contain a through-hole that can be used to guide the needle. In some embodiments, in addition to a cutout, an additional element may be incorporated as part of the needle guide. This additional element may be configured to hold and then release the needle after positioning, to, for example, allow a patient to resume breathing after needle placement.
  • Fig. 8B is a block diagram showing a system configuration, including a user, in this embodiment. The operation of each block and input and output signals in this embodiment will be described with reference to Fig. 8B.
  • the user specifies a plurality of target positions in the coordinate system of the medical support device via an input device 200.
  • An angle calculation unit 2 finds two combinations of target angles of the two rotational elements for each of the input target positions, and outputs them to an interference analysis unit 3. For example, when two target positions Pa (xa, ya, za) and Pb (xb, yb, zb) are input, combinations of target angles (9ai, 9a2) and (9ai', 9a2') for the target position Pa are output. Combinations of target angles (9bi, 9b2) and (9bi', 9b2') for the target position Pb are output.
  • the target positions are input as coordinates. In other embodiments, the target positions are provided by the user by indicating the position directly on a tomographic medical image (e.g., via a touch or a pointing device).
  • the calculation may be a calculation of general inverse kinematics, so the description thereof will be omitted.
  • the interference analysis unit 3 finds the equations of straight lines 20 showing the directions in which needle-like instruments 10 are inserted, from the combinations of target angles input from the angle calculation unit 2. Then, the interference analysis unit 3 finds the distances between straight lines to different targets from the found equations of straight lines.
  • the interference analysis unit 3 finds the equations of straight line La and straight line La' from the combinations of target angles (9ai, 9a2) and (9ai', 9a2'), and finds the equations of straight line Lb and straight line Lb' from the combinations of target angles (9bi, 9b2) and (9bi', 9b2').
  • the interference analysis unit 3 selects the combination that is largest in distance between straight lines from four combinations La-Lb, La-Lb', La'-Lb, and La'- Lb'.
  • La- Lb is selected.
  • the selected combination of target angles is presented on a presentation portion 4.
  • Presentation portion 4 may be, for example, a display unit such as a monitor, and it may be integrated into the display of the medial image.
  • the presentation portion may be, for example, a small display located on the device.
  • the calculation performed in the interference analysis unit 3 is a general calculation for finding the distance between two straight lines in a three- dimensional space, so the detailed description thereof will be omitted.
  • the user optionally confirms the target angles presented on the presentation portion 4, and rotates the first rotational element 11 in Fig. 1 and the second rotational element 12 in Fig. 1 manually such that they are at the presented target angles.
  • the user changes the position of the first rotational element 11 and the second rotational element 12 manually by referring the position detection units 6a and 6b provided on the rotational elements 11 and 12.
  • the positioning of rotational elements 11 and 12 is automated and the presentation portion is optional.
  • the needle guide 13 faces the target position Pa. By inserting a needle-like instrument 10a along the cutout of the needle guide 13 in this attitude, the instrument can be inserted at the target position Pa as shown in Fig. 5A.
  • the needle guide 13 faces the target position Pb.
  • the instrument can be inserted at the target position Pb.
  • needle-like instruments 10 are inserted at both the target position Pa and the target position Pb.
  • Fig. 9 illustrates an example of hardware of the computing unit 100.
  • a processor 101 reads and executes a program code stored in a hard disk device 103 to execute a various type of process and control.
  • a ram 102 temporarily stores information pieces, such as a program code executed by the processor 101.
  • the hard disk device 103 stores a program code and a various type of date for performing processes and/ or operations described with Fig. 8B above.
  • An input device interface 104 receives a user input to the computer unit 100 from an input device 200 such as a keyboard, a mouse, a joystick, or a touch pad.
  • An output device interface 105 outputs data to an output device such as a display and a recording apparatus.
  • a peripheral interface 106 performs data and/ or signal communication with an external device (for example, the Mechanical portion 1).
  • the mechanical portion 1 may be fixed to the object with tape, adhesive, or the like.
  • the base 15 may be provided with a part to which a belt-like instrument is attached, and the mechanical portion 1 may be fixed to the object with a belt or the like. If the mechanical portion 1 can be fixed to the object with bolts, the base 15 may be provided with holes into which bolts or other fixation elements are inserted.
  • the rotational elements do not necessarily have to be annular (ring-shaped) and arcuate, and only have to be mechanisms having two orthogonal rotation axes.
  • the position detection units 6 do not necessarily have to be scale-like, and may be optical or electrical detectors, for example, encoders or potentiometers. In that case, the present angle can be displayed on the presentation unit 4 or the like.
  • the movable portion of the first rotational element 11 can rotate ⁇ 180 degrees.
  • the present invention is not limited to this. The present invention can be applied even if 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 rotational element 12 can be wide.
  • the wider the range of movement the wider the range of puncture from the same installation position.
  • this range is not limited as long as puncture target positions are within the range.
  • the shape of the needle guide 13 does not necessarily have to be a cutout such as the triangular-shaped cutout as shown in Figs. 3 and 4, and may be, for example, a tubular shape, a cylindrical shape, a trough shape, or such a shape that two parts hold an instrument there between (for example, two triangular, rectangular, or semicircular cutouts in two parts of a needle guide that are held or hinged together).
  • the present invention is not limited to this, and three, four, five or more needle guides 13 of different angles may be used.
  • the needle guide 13 is inclined in a plane in which the second rotational element 12 rotates.
  • the present invention is not limited to this, and the needle guide 13 may be inclined in another direction, or may be translated.
  • the needle guide 13 may have a mechanism having a degree of freedom such as those shown in Figs. 10A to 10C, Figs. 11A to 11C, and Figs. 12A to 12C so that the direction and angle of puncture can be changed freely.
  • Figs. IOA, 11A, and 12A are front views
  • Figs. 10B, 11B, and 12B are plan views
  • Figs. 10C, 11C, and 12C are side views.
  • the needle guide 13 is attached to the movable portion 12b of the second rotational element 12, and is movable with only a predetermined degree of freedom owing to a groove 130 provided in the direction of degree of freedom and a fixing screw 131. By tightening the fixing screw 131, the needle guide 13 can be fixed at a set angle.
  • Fig. 10 shows an example of a configuration that achieves a degree of freedom about a rotation axis parallel to the rotation axis of the second rotational element.
  • Fig. 11 shows an example of a configuration that achieves a degree of freedom about a rotation axis perpendicular to the rotation axis of the second rotational element.
  • Fig. 12 shows an example of a configuration that makes it possible to translate the needle guide 13 in the direction of the rotation axis of the second rotational element without changing the puncturing direction.
  • only one combination determined by the interference analysis unit 3 is presented on the presentation portion 4.
  • the present invention is not limited to this. For example, four combinations of straight lines and the distance between two straight lines in each combination may be presented so that the user can select which combination to use. Combinations causing interference are preferably 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 three, four, five, or more. In that case, the number of combinations processed in the interference analysis unit 3 is 2 to the power of n, where n is the number of targets.
  • one or more of the needle guide 13 can be configured to direct a needle to a point further away from the origin, or a plurality of needle guides 13 can be configured to face in different directions so that they can be interchanged.
  • a second embodiment of the present invention will be described with reference to Fig. 6 to Fig. 8A.
  • First, the schematic configuration of a mechanical portion of a medical support device of this embodiment will be described with reference to Fig. 6 and Fig. 7.
  • a base 15 of a mechanical portion 1 is first fixed and installed on an object to be punctured with a fixing unit (not shown). This includes, for example, the torso of a patient.
  • Fig. 7 is a sectional view of the configuration of Fig. 6 cut along the ZY-plane.
  • a stationary portion of an annular, or ring shaped first rotational element 11 is attached to the fixing unit.
  • a stationary portion of an annular second rotational element 12 is attached to a movable portion of the rotational element 11 with a supporting portion 14 there between.
  • the rotational element 11 and the rotational element 12 are configured such that the rotation axis 22 of the movable portion of the second rotational element 12 is inclined at a predetermined angle a with respect to the rotation axis 21 of the movable portion of the first rotational element 11 and intersects therewith at the origin of the XYZ coordinate.
  • a needle guide 13 (not shown) is attached to the movable portion of the second rotational element 12. As in the first embodiment, the needle guide 13 has a cutout. By inserting a needle-like instrument 10 along the cutout, the insertion direction of the instrument 10 is guided.
  • the straight line 20 shows the direction in which the needle guide 13 guides a needle-like instrument 10 in this embodiment.
  • the first rotational element 11 and the second rotational element 12 are provided with position detection units 6a and 6b, with which the rotation angle of each rotational element can be detected.
  • the position detection units 6a and 6b output the signal indicating the rotation angle of each rotational elements 11 and 12.
  • the signals output from the position detection units 6a and 6b are input to the control portions 5a and 5b.
  • the first rotational 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.
  • the second rotational element 12 is connected to a drive source 7b provided on the supporting portion 14 by a transmission mechanism (not shown), and the movable portion is driven by the drive source 7b.
  • markers 30 are attached to the medical support device.
  • some embodiments include at least three markers 30 that can be imaged by MRI, CT, or both MRI and CT are attached to the mechanical portion 1.
  • markers 30 are attached.
  • the hard disc device 103 in Fig. 9 stores a program code and a various type of date for performing processes and/or operations described with Fig. 8A below.
  • a tomographic image of the mechanical portion 1 installed on the object is obtained by MRI or CT.
  • a coordinate conversion unit 8 detects the plurality of markers 30 that are attached to or otherwise installed on the mechanical portion 1 from the tomographic image, and calculates the installation position and attitude of the mechanical portion 1 based on the medical image from the positional relationship between the plurality of markers 30.
  • the user specifies a plurality of target positions on the tomographic image. These positions are sent to computing unit 100 which includes a coordinate conversion unit 8, angle calculation unit 2, interference analysis unit 3, and one or more control portions 5a and 5b.
  • the coordinate conversion unit 8 converts the plurality of target positions specified on the tomographic image into a plurality of target positions in the coordinate system of the mechanical portion 1 on the basis of the calculated installation position and attitude of the mechanical portion 1, and outputs them to an angle calculation unit 2.
  • An angle calculation unit 2 finds two combinations of target angles of the two rotational elements for each of the input target positions, and outputs them to an interference analysis unit 3. For example, when two target positions Pa (xa, ya, za) and Pb (xb, yb, zb) are input, combinations of target angles (9ai, 9a2) and (9ai', 9a2') for the target position Pa are output. Combinations of target angles (9bi, 9b2) and (9bi', 9b2') for the target position Pb are output.
  • the interference analysis unit 3 finds the equations of straight lines 20 showing the directions in which needle-like instruments 10 are inserted, from the combinations of target angles input from the angle calculation unit 2. Then, the interference analysis unit 3 finds the distances between straight lines to different targets from the found equations of straight lines.
  • the interference analysis unit 3 finds the equations of straight line La and straight line La' from the combinations of target angles (9ai, 9a2) and (9ai', 9a2'), and finds the equations of straight line Lb and straight line Lb' from the combinations of target angles (9bi, 9b2) and (9bi', 9b2').
  • the interference analysis unit 3 selects the combination that is largest in distance between straight lines from four combinations La-Lb, La-Lb', La'-Lb, and La'-Lb'.
  • La- Lb is selected as the combination that is largest in distance between straight lines. The largest distance is selected to minimize the possible interference. In other embodiments, it is unnecessary to select the combination that is largest in distance.
  • the interference analysis unit 3 outputs target angle 9ai to a control portion 5a that is a control portion of the first rotational element 11.
  • the interference analysis unit 3 outputs target angle 9bi to a control portion 5b that is a control portion of the second rotational element 12.
  • the control portion 5a controls the position of the movable portion of the first rotational element 11 by outputting a drive command to the drive source 7a provided to the first rotational element 11 on the basis of target angle 9ai input from the interference analysis unit 3, and the position detection unit 6a attached to the first rotational element 11. Specifically, the control portion 5a outputs a drive command based on the difference between the present angle obtained from the position detection unit 6a and target angles 9ai, and performs control such that target angle 9ai is reached.
  • control portion 5b controls the position of the movable portion of the second rotational element 12 by outputting a drive command to the drive source 7b provided to the second rotational element 12 on the basis of target angle 9bi and the signal obtained from the position detection unit 6b attached to the second rotational element 12.
  • the interference analysis unit 3 may output the rotational position of the rotational elements and then allow for manual adjustment of the rotational elements.
  • the interference analysis unit 3 may output both the drive command to cause the rotation of the rotational elements and also the rotational positions so that the automated rotation may be verified by the user.
  • the needle guide 13 faces the target position Pa.
  • the instrument can be inserted at the target position Pa.
  • the drive sources 7a and 7b are driven such that the rotational elements 11 and 12 are at the target angles 9bi and 9b2 thereof.
  • the needle guide 13 faces the target position Pb.
  • FIG. 13 an example of apparatus of a detachable needle guide is presented.
  • the lower mating surface 24 is attached to the first rotational element or base (not shown).
  • the needle guide can be attached and detached at the will of the user.
  • the needle guide can be slid into and out of a groove, onto a pin-like structure, or it can contain a snap closure for securing and removing from the apparatus.
  • the removable mating surface 25 of the rotational element 12 includes a needle guide 13.
  • the removable mating surface of the needle guide 25 can be attached and removed from a secure position by pressing bosses 26 on the top of the lower mating surface 24 into holes 27 on the upper mating surface of the needle guide 25.
  • Each needle guide 13 can have a unique shape such that a needle-like instrument 10 can be inserted without colliding with previously inserted needles.
  • the cutouts on each needle guide can be formed so they rest at different heights. This will guide the needle to an entry point which would be above or below the intersection of the rotation axis of the two rotational elements 11 and 12.
  • two needle guides 13 and 13b of different heights are overlaid. In this figure, the example shows the different points the guide 13 meets with the rotational axis of the lower ring 21.
  • a fourth embodiment of the present invention a system of using a unique and preselected needle guide for each individual needle inserted, will be described with reference to Figs. 15A -15C.
  • each needle guide can be used in a predetermined order. These needle guides can vary in design to ensure each needle has a unique insertion path and will not interfere with previously inserted or future needles.
  • the user can determine which needle guide to use by markings on the needle guide that are unique to each design.
  • the markings can be include numbers, letters, colors, or names, or any variation or combination there-of.
  • Fig. 15 shows an example of three differently designed needles guides each having a unique marking on them for identification.
  • the procedural workflow or software can tell the user which sequence to use.
  • the software can modify the kinematics algorithm to adjust for the unique design of each needle guide.
  • the user 19 will select the first needle guide 13, as denoted by the workflow, and attach it to the second rotational element 12.
  • the user 19 will sent the target to the controller through the software and the robot will rotate the rotational elements to align the first needle guide to the target.
  • the user 19 will then insert the needle through the guide until it reaches the target.
  • the user 19 will remove the first needle guide 13 from the second rotational element 12 and discard of it.
  • the user 19 will then take the second needle guide 13, as denoted by the workflow, and attach it to the second rotational element 12.
  • the user 19 will send the target to the controller through the software and the robot will rotate the rotational elements to align the second needle guide to the target.
  • the user will not have to change any settings of the software since the software already knows the order the needle guides will be used in.
  • the user will insert the needle and repeat this process until all needles are placed.
  • the system of using a user-selected needle guide for each individual needle inserted will be described.
  • the user can decide which needle guide to use so the insertion of the next needle will not collide with previously inserted needles.
  • the needle guides can be provided in a kit with a predetermined order, where each of the needle guides is provided such that when used in order, the inserted needles will not collide with each other, even without the need to move the patient's skin or prior needle.
  • the device and associated software can detect which needle guide is inserted and update the kinematics algorithm to match the current guide.
  • FIG. 16 an example of a needle guide used in a system where the needle guide identity is sensed using a key design 28 is shown. For simplicity, only the needle guide and key 28 is shown. In this design, different pins are depressed depending on the shape of the key 28 attached to the needle guide. Based upon the combination of which pins are pressed, the identity of the needle guide can be deciphered.
  • FIG. 17 an example is shown of a system where an optical sensor 29 detects a unique marking on the needle guide to identify which is being used. For simplicity, only the marking is shown. In this design, the visual markings are detected by an optical sensor 29 and the software can determine which needle guide design matches the detected markings.
  • a pivot point 30 exists where, when using a needle guide 13, a needle or other needle like instrument must pass through in order to reach all target positions within a reachable volume 32.
  • the needle reachable volume 32 is a cone shaped volume where the tip of the cone is located at the pivot point 30 and extends into the patient.
  • the pivot point 30 can be located in a number of locations relative to the skin 34 of the patient.
  • the pivot point 30 can be above the skin 34, on the skin 34, or within the patient. This can be defined by the design of the medical support device and optionally any other device or component mounted on the patient.
  • the addition of an RF coil beneath the medical support device where the device initially has a pivot point at the skin moves the pivot point to a position above the skin's surface. If the pivot point 30 coincides with a location on the skin 34of the patient (as shown in Fig. 18) or within a patient then this prevents accurate targeting when using multiple needles with a needle guide 13. For insertion, each needle path must be altered to move around prior needles because prior needles will pass through the pivot point 30.
  • the pivot point 30 can also be offset from intersection 23. In the case where the pivot point 30 is located above the patient a desired needle path for multiple needles through the pivot point can be maintained even when using multiple needles without the needles overlapping.
  • user 19 can tilt the first needle to move the needle out of the way while inserting the next needle. Due to the first needle already being located within the patient, the tip will be stationary and just the portion of the needle remaining outside the patient will bend away from pivot point 30.
  • the medical support device has a remote center of motion (RCM) which is located above the subject when placed on the subject.
  • RCM remote center of motion
  • the height of the needle guide is changed, thus modifying the pivot point 30 of the needle.
  • the pivot point 30 will shift upwards.
  • This shift has multiple effects.
  • One effect is the shift in initial puncture point 36 due to shift of initial needle path 38.
  • a new puncture point 40 is created following needle path 42. For example if the pivot point 30 is originally at the surface of the skin, and then the pivot point 30 is shifted upward then the initial puncture point 36 will be shifted outward.
  • Another effect is the change in reachable volume 32 if we assume a fixed needle length. By changing the pivot point the reachable volume 32 is shifted.
  • a first needle-like instrument is inserted at a first puncture starting point and then the medical support device (or a portion of the medical support device) is moved upwards, away from the patient's skin.
  • a second needle-like instrument is inserted into a second puncture starting point that is different from the first puncture starting point.
  • the shape of the cone that represents the reachable volume 32 of the needle is modified.
  • the cone In the case with angle ⁇ the cone is narrower and can reach deeper past the surface. In the case with angle ⁇ the cone is wider and reaches a volume that is shallower.
  • a first needlelike instrument is inserted at a first puncture starting point where the needle guide holds the needle at an angle ⁇ .
  • a second needle-like instrument is inserted via a second needle guide that holds the needle at angle ⁇ . This second needle is inserted into a second puncture starting point that is different from the first puncture starting point.
  • the inclination a of the second rotational element is set to 20 degrees, and the diameter of the needle-like instruments 10 is set to 2 mm.
  • the initial position of the first rotational element 11 is set to such a position that the second rotation axis 22 is in the YZ plane.
  • the initial position of the second rotational element 12 is set to such a position that, when a needle guide 13 (different from the needle guide in this description) intersecting with the intersection 23 of rotation axes is attached, a straight line showing the guiding direction coincides with the Y-axis.
  • the straight line showing the guiding direction of the needle guide 13 is set to be a straight line passing through two points (o mm, 50 mm, o mm) and (5 mm, o mm, o mm) on the XYZ coordinate in a state where the mechanical portion 1 is at the initial position.
  • This straight line is expressed by the following equation (1) using parameter t:
  • 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).
  • the interference analysis unit 3 finds straight lines La, La', Lb, and Lb' showing the guiding direction of the needle guide 13 in each attitude from the configuration of the mechanical portion 1 and the input combinations of target angles of the rotational elements.
  • the interference analysis unit 3 finds the distance between two straight lines in each of four possible combinations La-Lb, La-Lb', La'-Lb, and La'-Lb'.
  • the distance between two straight lines in each combination is as follows:
  • La'-Lb 8.93 mm
  • La'-Lb' 2.28 mm
  • the angle calculation unit 2, the interference analysis unit 3, and the control portion 5 are described as separate units. However, this is a conceptual separation. For example, these units may be incorporated in a CPU as pieces of software at the same time. Alternatively, a single software program may perform multiple functions. In some embodiments, one or more of the angle calculation unit 2, the interference analysis unit 3, and the control portion 5 is a dedicated piece of firmware.
  • 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 three, four, five or more. As more needles are used, the possibility that interference between the various instruments occurs is increased.
  • the needle guide 13 can be caused to face a point further away from the origin, or a plurality of needle guides 13 facing in different directions can be prepared.
  • a needle holder having needle guides 13 with only a small deflection from the intersection of the rotation axis of the two rotational elements may be used when only a few needles need to be place and needle guides having a greater deflection are used when more needles are indicated in a procedure.
  • the needle placement apparatus can include interchangeable needles guides so the different to account for differences needed in the deflection.
  • needle guides 13 facing in a plurality of directions are interchanged, the present invention is not limited to this.
  • needle guides facing in different directions may be provided at the positions of o degrees and 180 degrees of the movable portion of the second rotational element, and which needle guide to use may be selected on the basis of the analysis result of the interference analysis unit 3.
  • the needle guide 13 may have, as in the first embodiment, a mechanism having a degree of freedom such as those shown in Figs. 10A to 10C, Figs. 11A to 11C, and Figs. 12A to 12C so that the direction of puncture can be changed freely.
  • the markers 30 are disposed on the base 15 as shown in Fig. 6 in this embodiment, the present invention is not limited to this, and the markers 30 may be disposed on the first rotational element 11 or the second rotational element 12. In this case, it may be necessary to detect the angle of each rotational element, and to record the position of each marker 30 in the coordinate system of the support device. In other embodiments the markers may be used, for example, for identifying kinds of needle, diameter, cryo-, radio, datum height of needle insertion, etc.
  • the rotational elements 11 and 12 and the drive sources 7a and 7b are connected by transmission mechanisms.
  • the transmission mechanisms can be constructed by using, for example, gears or a timing belt.
  • the medical support device is designed to be placed on a patient.
  • the first needle-like instrument is guided by the needle guide and is inserted into the body of a patient at a pre-determined angle and having a predetermined first puncture starting point where it punctures the patient's skin.
  • the medical support device is placed on a patient above the patient's liver.
  • An MRI image is obtained while the medical support device is affixed to the patient.
  • An insertion trajectory is planned using the initial MRI image.
  • the planning may include, for example, selecting different locations in a liver lesion for radio frequency ablation by touching the position points on a touch screen showing the MRI image.
  • the coordinate conversion unit converts these positions on the image into target positions in the coordinate system.
  • the angle calculation unit 2 then calculates combinations of target angles of the two rotational elements that provide correct needle insertion parameters for each the input target positions, and outputs the parameters to an interference analysis unit 3. Then, the medical support device is instructed to move the needle-like instrument guide into the first position.
  • This probe location may be confirmed with an intra-procedural image.
  • the user may then verify the location and insert the needle-like device into the patient's liver.
  • the needle-like device may be partially inserted and a confirmation image taken prior to full insertion of the needle-like instrument.
  • Embodiment(s) of the present invention can also be realized by a computer of a system or apparatus that reads out and executes computer executable instructions (e.g., one or more programs) recorded on a storage medium (which may also be referred to more fully as a 'non-transitory computer-readable storage medium') to perform the functions of one or more of the above-described embodiment(s) and/ or that includes one or more circuits (e.g., application specific integrated circuit (ASIC)) for performing the functions of one or more of the above-described embodiment(s), and by a method performed by the computer of the system or apparatus by, for example, reading out and executing the computer executable instructions from the storage medium to perform the functions of one or more of the above-described embodiment(s) and/ or controlling the one or more circuits to perform the functions of one or more of the above-described embodiment(s).
  • ASIC application specific integrated circuit
  • the computer may comprise one or more processors (e.g., central processing unit (CPU), micro processing unit (MPU)) and may include a network of separate computers or separate processors to read out and execute the computer executable instructions.
  • the computer executable instructions may be provided to the computer, for example, from a network or the storage medium.
  • the storage medium may include, for example, one or more of a hard disk, a random-access memory (RAM), a read only memory (ROM), a storage of distributed computing systems, an optical disk (such as a compact disc (CD), digital versatile disc (DVD), or Blu-ray Disc (BD)TM), a flash memory device, a memory card, and the like.
  • proximal and distal may also be interchangeable, where applicable.
  • the terms “about” or “approximately” mean within an acceptable range for the particular parameter specified as determined by one of ordinary skill in the art, which will depend in part on how the value is measured or determined, e.g., the limitations of the sample preparation and measurement system. For example, “about” can mean a range of up to 20% of a given value, and more preferably means a range of up to 10%.
  • first, second, third, etc. may be used herein to describe various elements, components, regions, parts and/ or sections. It should be understood that these elements, components, regions, parts and/or sections should not be limited by these terms. These terms have been used only to distinguish one element, component, region, part, or section from another region, part, or section. Thus, a first element, component, region, part, or section discussed below could be termed a second element, component, region, part, or section without departing from the teachings herein.

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  • Surgical Instruments (AREA)

Abstract

L'invention concerne un dispositif de support médical pour maintenir et positionner une aiguille. Ce dispositif est particulièrement utile pour le positionnement des aiguilles dans un traitement de ponction moins invasif. Ce dispositif comprend deux éléments rotatifs et au moins un guide d'aiguille fixé à un élément rotatif. Le guide d'aiguille guide la direction de l'insertion d'un instrument de type aiguille et comprend une partie de guidage qui guide une aiguille, ou un autre instrument de type aiguille, lequel point de ponction de l'aiguille dans une première position est différent du point de ponction lorsque le guide d'aiguille guide l'aiguille dans une seconde position.
PCT/US2015/040336 2015-07-14 2015-07-14 Dispositif de support médical Ceased WO2017010992A1 (fr)

Priority Applications (2)

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JP2018501957A JP7030682B2 (ja) 2015-07-14 2015-07-14 医療支援デバイス
PCT/US2015/040336 WO2017010992A1 (fr) 2015-07-14 2015-07-14 Dispositif de support médical

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CN108143502A (zh) * 2017-12-27 2018-06-12 冯颖 一种能精确引导留置引流管的脑立体定向仪
CN109394349A (zh) * 2018-12-19 2019-03-01 冷洪雷 一种疼痛科用麻醉穿刺固定器
CN111166440A (zh) * 2020-02-25 2020-05-19 张纪良 一种胸部穿刺定向辅助装置
US11707259B2 (en) 2018-10-19 2023-07-25 Canon U.S.A., Inc. Wireless needle guidance using encoder sensor and encoder scale to achieve positional sensing between movable components
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CN110650689B (zh) * 2017-03-28 2022-05-17 恩特范特格诊断公司 用于鼻窦炎诊断的装置和方法

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CN108143502A (zh) * 2017-12-27 2018-06-12 冯颖 一种能精确引导留置引流管的脑立体定向仪
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CN118216988A (zh) * 2024-05-06 2024-06-21 广西医科大学附属肿瘤医院 一种颅脑穿刺用定向器

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