WO2012165303A1 - 超音波用穿刺針 - Google Patents
超音波用穿刺針 Download PDFInfo
- Publication number
- WO2012165303A1 WO2012165303A1 PCT/JP2012/063382 JP2012063382W WO2012165303A1 WO 2012165303 A1 WO2012165303 A1 WO 2012165303A1 JP 2012063382 W JP2012063382 W JP 2012063382W WO 2012165303 A1 WO2012165303 A1 WO 2012165303A1
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- WO
- WIPO (PCT)
- Prior art keywords
- ultrasonic
- needle tube
- puncture needle
- needle
- ultrasonic puncture
- Prior art date
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-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
- A61B8/00—Diagnosis using ultrasonic, sonic or infrasonic waves
- A61B8/12—Diagnosis using ultrasonic, sonic or infrasonic waves in body cavities or body tracts, e.g. by using catheters
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
- A61B17/00—Surgical instruments, devices or methods, e.g. tourniquets
- A61B17/34—Trocars; Puncturing needles
- A61B17/3478—Endoscopic needles, e.g. for infusion
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
- A61B8/00—Diagnosis using ultrasonic, sonic or infrasonic waves
- A61B8/44—Constructional features of the ultrasonic, sonic or infrasonic diagnostic device
- A61B8/4444—Constructional features of the ultrasonic, sonic or infrasonic diagnostic device related to the probe
- A61B8/445—Details of catheter construction
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
- A61B1/00—Instruments for performing medical examinations of the interior of cavities or tubes of the body by visual or photographical inspection, e.g. endoscopes; Illuminating arrangements therefor
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
- A61B17/00—Surgical instruments, devices or methods, e.g. tourniquets
- A61B17/34—Trocars; Puncturing needles
- A61B17/3468—Trocars; Puncturing needles for implanting or removing devices, e.g. prostheses, implants, seeds, wires
-
- 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
- A61B90/36—Image-producing devices or illumination devices not otherwise provided for
- A61B90/37—Surgical systems with images on a monitor during operation
- A61B2090/378—Surgical systems with images on a monitor during operation using ultrasound
- A61B2090/3782—Surgical systems with images on a monitor during operation using ultrasound transmitter or receiver in catheter or minimal invasive instrument
- A61B2090/3784—Surgical systems with images on a monitor during operation using ultrasound transmitter or receiver in catheter or minimal invasive instrument both receiver and transmitter being in the instrument or receiver being also transmitter
-
- 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
- A61B2090/3925—Markers, e.g. radio-opaque or breast lesions markers ultrasonic
-
- 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
- A61B2090/3987—Applicators for implanting markers
Definitions
- the present invention relates to an ultrasonic puncture needle used for introduction into a body cavity and delivery of a drug or a treatment device into the body.
- EUS-FNA Endoscopic Ultrasound-guided Fine Needle Aspiration
- the substance delivered from the needle tube may not be confirmed on the ultrasonic image.
- the direction in which the substance is sent out from the needle tube must coincide with the ultrasonic observation surface.
- the ultrasonic endoscope has a long and flexible insertion portion, and the insertion portion is bent into a complicated shape when it reaches a target site in the body. Therefore, it is difficult to adjust the angular position around the axis of the needle tube that has passed through the insertion portion by an operation from the hand operation portion. In addition, it is difficult to always position the opening for releasing the substance provided on the needle tube on the ultrasonic observation surface. For this reason, the appearance of the substance being delivered cannot be observed with an ultrasonic endoscope, and it may be difficult to accurately deliver the substance to the region of interest.
- An object of the present invention is to provide an ultrasonic puncture needle capable of accurately sending a substance to a site of interest while observing how the substance is delivered.
- the ultrasonic puncture needle according to the first aspect of the present invention is an ultrasonic puncture needle that includes a sheath, an operation unit, a needle tube, and a release mechanism, and is used in combination with an ultrasonic endoscope. .
- the sheath is inserted into an insertion channel of the ultrasonic endoscope so as to be able to advance and retract.
- the operation unit is disposed at a proximal end portion of the sheath, and also serves as a gripping unit that a user grips.
- the needle tube is inserted into the sheath, an opening is formed in the distal end region, and the tissue in the body cavity is punctured.
- the discharge mechanism is provided on the proximal end side of the needle tube, and discharges the loaded substance to the outside from the opening of the needle tube. Furthermore, when the needle tube receives a force from the inner wall of the insertion channel, an axis line that coincides with the direction of the opening of the needle tube protruding from the insertion channel is substantially parallel to the ultrasonic scanning plane by the ultrasonic endoscope. Is rotated about the longitudinal axis of the insertion channel.
- the needle tube is formed into a smooth arc shape at least near the tip in the natural state, and the direction of viewing the opening of the needle tube in the maximum area is the arc of the needle tube. It is substantially parallel to the plane formed by the shape.
- the needle tube has an eccentric outer diameter and a center of the lumen, and the direction of viewing the opening of the needle tube in the maximum area is the thinnest portion and the thickest wall of the needle tube. It is substantially parallel to the cross section connecting the parts.
- the needle tube is formed in a shape having a flat outer diameter cross section, and a direction in which the opening of the needle tube is viewed in a maximum area is short of the flat shape of the needle tube. It is substantially parallel to the radial cross section.
- the needle tube is formed into a smooth arc shape at least near the tip in a natural state, and the most proximal side of the opening of the needle tube is formed by the arc shape of the needle tube. It lies on the plane that is constructed.
- the needle tube has an eccentric outer diameter and a center of the lumen, and the most proximal side of the opening of the needle tube is the thinnest portion and the thickest portion of the needle tube. On the cross-section.
- the needle tube has a flat outer diameter cross section, and the most proximal side of the opening is on the flat cross section in the minor axis direction.
- the cross section of the lumen of the needle tube has a flat shape, and the direction in which the opening is viewed in the maximum area is parallel to the major axis direction of the flat shape.
- the tip surface of the needle tube is subjected to ultrasonic reflection processing for obtaining a reflection echo, and the ultrasonic reflection processing is applied to the periphery of the opening and others. It is different in the part of.
- the tip region includes a tip.
- the tip region includes the vicinity of the tip.
- the substance includes a gas.
- the substance includes a liquid.
- the substance includes a solid.
- the solid includes an elongated elastic body.
- the state in which the substance is delivered can be suitably observed with the ultrasonic endoscope by matching the angular position of the opening of the needle tube with the ultrasonic observation surface of the ultrasonic endoscope.
- the substance can be accurately sent to the region of interest.
- 1 is an overall view showing an ultrasonic endoscope used in combination with an ultrasonic puncture needle according to a first embodiment of the present invention. It is a perspective view which shows the front-end
- FIG. 1 is a diagram showing a configuration of an ultrasonic endoscope.
- FIG. 2 is a perspective view showing the distal end portion of the ultrasonic endoscope.
- FIG. 3 is a front view of the front end portion shown in FIG. 2 as viewed from the front.
- FIG. 4 is a perspective cross-sectional view of the distal end portion of the ultrasonic endoscope.
- the ultrasonic endoscope 1 includes an elongated insertion portion 2 to be inserted into a body cavity, an operation portion 3 provided at the proximal end of the insertion portion 2, and a universal cord 4 extending from a side portion of the operation portion 3. It is configured with.
- An endoscope connector 5 is provided at the base end of the universal cord 4.
- An ultrasonic cable 6 extends from the side of the endoscope connector 5.
- An ultrasonic connector 7 is provided at the proximal end of the ultrasonic cable 6.
- the insertion portion 2 is, in order from the distal end side, a distal end rigid portion 2a formed of a rigid member, a bending portion 2b configured to be bendable, and a long length from the proximal end of the bending portion 2b to the distal end of the operation portion 3.
- the flexible tube portion 2c having flexibility is configured to be connected.
- the ultrasonic transducer section 10 forms an ultrasonic observation surface 10A that scans the front direction with respect to the insertion axis direction.
- the ultrasonic transducer section 10 has an ultrasonic observation surface 10A that scans in the forward direction.
- a signal cable (not shown) is connected to the ultrasonic transducer unit 10. This signal cable extends through the insertion portion 2, the operation portion 3, the universal cord 4, the endoscope connector 5, and the ultrasonic cable 6 to the ultrasonic connector 7.
- the ultrasonic connector 7 is connected to an ultrasonic observation apparatus (not shown).
- the ultrasonic observation apparatus exchanges signals with an ultrasonic transducer through a signal cable, converts a signal received from the ultrasonic transducer into an ultrasonic image, and displays it on a monitor (not shown).
- the operation unit 3 is provided with an angle knob 3a for performing a bending operation.
- a bending wire (not shown) corresponding to the operation is pulled and relaxed, and the bending portion 2b performs a bending operation.
- the ultrasonic transducer portion 10 is configured to protrude from the distal end surface 21 of the distal end hard portion 2 a in the distal end hard portion 2 a of the insertion portion 2. Furthermore, an observation window 22, an illumination window 23, and an insertion channel outlet 24 are provided on the distal end surface 21 of the distal end rigid portion 2a.
- the observation window 22 constitutes the most distal end side of an observation optical system (not shown).
- the illumination window 23 constitutes the most distal end side of an illumination optical system (not shown).
- the insertion channel outlet 24 is an opening of a treatment instrument insertion channel from which a treatment instrument such as a puncture needle is led out.
- the insertion channel outlet 24 is provided substantially parallel to the longitudinal axis direction of the distal end hard portion 2 a and is connected to a treatment instrument insertion channel (hereinafter abbreviated as “insertion channel”) 27 disposed in the insertion portion 2. (See FIG. 4).
- insertion channel treatment instrument insertion channel
- the observation optical system and illumination optical system extend to the endoscope connector 5 through the insertion section 2, the operation section 3, and the universal cord 4.
- the endoscope connector 5 is connected to an endoscope observation apparatus (not shown).
- the endoscope observation apparatus transmits illumination light to the illumination window 23 through the illumination optical system, and the illumination light illuminates the front of the distal end hard portion 2a. Further, the endoscope observation apparatus displays a signal delivered from the observation window 22 via the observation optical system as an observation image on a monitor (not shown). Therefore, an observation image illuminated with illumination light is displayed on the monitor.
- the proximal end side of the insertion channel 27 communicates with a treatment instrument insertion port 3 d provided in the operation unit 3.
- the proximal end portion of the treatment instrument insertion port 3d is formed in a luer lock shape to which a syringe can be connected.
- the treatment instrument inserted through the treatment instrument insertion port 3d is led out from the insertion channel outlet 24.
- the central axis L2 of the insertion channel outlet 24 is substantially parallel to the longitudinal axis direction of the distal end hard portion 2a.
- a surface defined by the central axis L2 and the vertical center line L3 of the ultrasonic transducer section 10 is configured to substantially coincide with the ultrasonic observation surface 10A. Since the treatment instrument derived from the insertion channel outlet 24 is derived on the ultrasonic observation surface 10A, it is displayed so as to be visible on the ultrasonic image.
- FIG. 5 is a diagram showing the configuration of the ultrasonic endoscope 1 ′.
- FIG. 6 is a perspective view showing the distal end portion of the ultrasonic endoscope 1 ′.
- FIG. 7 is a front view of the front end portion shown in FIG. 5 as viewed from the front.
- FIG. 8 is a perspective sectional view of the distal end portion of the ultrasonic endoscope 1 ′.
- the ultrasonic endoscope 1 ′ portions having the same configuration as that of the ultrasonic endoscope 1 already described are denoted by the same reference numerals in FIGS. 5 to 8.
- the difference from the ultrasonic endoscope 1 is that the ultrasonic transducer section 10 ′ at the tip is larger.
- the ultrasonic observation surface 10A ′ that scans the front direction with respect to the insertion axis direction is formed at a wider angle.
- the insertion channel outlet 24 ′ of the ultrasonic endoscope 1 ′ is shown in FIG. 6 so that the treatment instrument derived from the insertion channel outlet does not contact the ultrasonic transducer section 10 ′ formed in a large size.
- the tip rigid portion 2a ′ is provided at an angle ⁇ with respect to the longitudinal axis direction.
- the surface constituted by the longitudinal center axis L2 ′ of the insertion channel outlet 24 ′ and the vertical center line L3 ′ of the ultrasonic transducer 10 ′ is configured to substantially coincide with the ultrasonic observation surface 10A ′. ing.
- This configuration is the same as that of the ultrasonic endoscope 1. Accordingly, the treatment instrument derived from the insertion channel outlet 24 ′ is derived on the ultrasonic observation surface 10 ⁇ / b> A ′ and displayed so as to be visible on the ultrasonic image.
- FIG. 9 is an overall external view of the ultrasonic puncture needle.
- 10 and 11 are overall sectional views.
- 12A, 12B, 13A, and 13B are explanatory views of the shape of the needle tube.
- 14A and 14B are explanatory views of the implant.
- the ultrasonic puncture needle 30 of this embodiment includes an insertion unit 31 and an operation unit 32.
- the insertion portion 31 is a portion that is inserted into the insertion channel 27 of the ultrasonic endoscope 1.
- the operation unit 32 is disposed at the proximal end of the insertion unit 31 and is fixed to the treatment instrument insertion port 3 d of the ultrasonic endoscope 1.
- the sheath 33 is a flexible tube and is located on the outermost side of the insertion portion 31.
- the material of the sheath 33 is preferably a resin such as polyether ether ketone, polyether sulfone, or Teflon (registered trademark).
- the material of the sheath 33 is preferably a metal wire generally called a flexible shaft, particularly a metal in which a stainless wire is wound in a coil spring shape.
- a needle tube 34 is inserted into the lumen of the sheath 33. The needle tube 34 and the inner surface of the insertion channel 27 are prevented from coming into direct contact with each other and the needle tube 34 and the insertion channel 27 are prevented from being damaged.
- the needle tube 34 is formed of a thin and thin wall such as a stainless steel pipe, and has a sharp tip.
- the needle tube 34 is inserted and disposed in the sheath 33 so as to advance and retract.
- FIGS. 12A to 13B Details of the vicinity of the tip of the needle tube 34 are shown in FIGS. 12A to 13B.
- the needle tube 34 is processed into a smooth arc shape at least in the vicinity of the tip in the natural state.
- the most distal portion of the needle tube 34 is not processed into an arc shape, but the distal end portion may be included in a range to be processed into an arc shape.
- the tip of the needle tube 34 has a shape in which the tip is cut off obliquely like a general injection needle, and a lumen is opened on the surface cut off obliquely.
- a direction perpendicular to the distal end surface that is, a direction in which the opening 34a is viewed in the maximum area (indicated by an arrow A1 in FIG. 12A) is substantially parallel to the plane 34b including the longitudinal center axis of the needle tube 34.
- the most proximal point 34d of the opening 34a is on the same plane as the plane 34b.
- the tip of the needle tube 34 is scraped in the opposite direction to the example shown in FIGS. 12A and 12B, but either may be selected depending on the purpose.
- the implant 35 is a metal piece containing a substance that emits very weak radiation for treatment. Details of the implant 35 are shown in FIGS. 14A and 14B.
- the shape is obtained by bending a rod-shaped material thinner than the lumen of the needle tube 34, and is a bar spring having elasticity. Since the implant 35 loaded near the distal end of the lumen of the needle tube 34 has elasticity, the inner wall of the needle tube 34 is always pushed by the force of returning to the original shape, so that it does not easily come off from the needle tube 34.
- the stylet 36 is an elongated line.
- the material of the stylet 36 is, for example, stainless steel or nickel titanium.
- the stylet 36 is detachably disposed on the proximal end side of the lumen of the needle tube 34. The stylet 36 pushes the implant 35 out of the needle tube 34 by an operation described later.
- the operation unit main body 37 is formed of a resin member.
- the slider 38 is slidably provided with respect to the operation unit main body 37.
- the slider 38 is formed of a resin member.
- the stopper 39 is a member that makes it possible to set the sliding distance of the slider 38 with respect to the operation unit main body 37 to a desired value according to the measurement result, and is configured as follows.
- the stopper member 39a is slidably disposed with respect to the operation portion main body 37.
- the material of the stopper member 39a is made of resin, for example.
- the fixing screw (stopper screw) 39b is screwed into the stopper member 39a to fix the stopper member 39a at a desired position.
- the material of the fixing screw 39b is made of metal or hard resin.
- the operation unit main body 37 is elongated and has a pipe shape in which a flange portion 37a is formed at the base end.
- a resin connection portion 40 to which the base end portion of the sheath 33 is fixed is bonded and fixed to the distal end portion of the operation portion main body 37.
- a screw 40 a that is connected and fixed to the treatment instrument insertion port 3 d of the ultrasonic endoscope 1 is formed on the distal end side of the connection portion 40.
- a concave portion 40 b in which the distal end portion of the operation portion main body 37 is disposed is formed at the proximal end portion of the connection portion 40.
- the sheath 33 is fixed with respect to the distal end connection portion 40c formed in the connection portion 40.
- a concave portion is formed on the inner peripheral surface of the flange portion 37a.
- An O-ring 41 that holds a guide pipe, which will be described later, is disposed in the concave portion of the flange portion 37a.
- a notch step portion 37b having a flat portion with which the front end surface of the fixing screw 39b abuts is formed at a predetermined position on the outer peripheral surface on the front end side from the flange portion 37a.
- the stopper member 39a When the stopper screw 39b is loosened, the stopper member 39a can be slid in the longitudinal direction on the operation portion main body 37.
- the maximum movable distance of the slider is set by sliding the stopper member 39a to an arbitrary position and screwing the fixing screw 39b to fix the stopper member 39a.
- the slider 38 is formed in a pipe shape in which a narrow diameter portion 38a is formed at the base end portion.
- a sliding arrangement member 42 for slidably arranging the slider 38 with respect to the operation section main body 37 is bonded and fixed to the tip of the slider 38.
- a resin base member 43 is disposed in the base end opening of the slider 38.
- a proximal end portion of the needle tube 34 and a proximal end portion of the guide pipe 44 that is held by the O-ring 41 are fixed to the distal end portion of the base member 43.
- the base end portion of the base member 43 has a luer lock shape that can be connected to a syringe or the like.
- the stylet 36 is inserted from the base member of the slider 38.
- a resin knob 36 a is integrally provided at the base end portion of the stylet 36.
- the ultrasonic puncture needle 30 configured as described above is assembled in a sterilization bag (not shown) after assembling the constituent members and sterilized.
- the ultrasonic puncture needle 30 housed in a sterilization bag (not shown) is taken out from the sterilization bag.
- the sheath 33 is inserted into the insertion channel 27 from the treatment instrument insertion port 3d of the ultrasonic endoscope 1, and the screw 40a provided at the connection portion 40 of the operation unit 32 is screwed into the treatment tool insertion port 3d.
- An ultrasonic puncture needle 30 is fixed to the ultrasonic endoscope 1.
- the ultrasonic image of the distal end portion of the sheath 33 is clearly depicted on the ultrasonic observation image displaying the target site.
- the positional relationship between the distal end of the sheath 33 and the target site is set. Thereafter, the distance between the distal end of the sheath 33 and the target site is measured.
- the fixing screw 39b is loosened, the stopper member 39a is slid on the operation portion main body 37 so as to correspond to the above-described distance, and the fixing screw 39b is fastened when the stopper member 39a is moved to a predetermined position.
- the surgeon grasps the slider 38 and quickly moves the slider 38 toward the stopper 39. This ensures that the tip of the needle tube 34 is punctured into the target site.
- the knob 36a of the stylet 36 is pushed into the tip side. Then, the stylet 36 moves to the distal end side, and the implant 35 is delivered from the opening 34a at the distal end of the needle tube 34 and is left in the body.
- the angular position around the axis of the needle tube 34 is controlled so that the direction in which the implant 35 is delivered matches the ultrasonic observation surface. Below, the method to make the direction in which the implant 35 is sent out correspond with an ultrasonic observation surface is demonstrated.
- the ultrasonic transducer 10 disposed at the tip of the ultrasonic endoscope 1 it is necessary to firmly apply the ultrasonic transducer 10 disposed at the tip of the ultrasonic endoscope 1 to the tissue in the body when observing an ultrasonic image.
- the bending portion 2b of the insertion portion 2 of the endoscope is usually used. It is necessary to bend in a direction called an up direction and face the body lumen tissue 50.
- the bending portion 2b has a substantially arc shape, and the insertion channel 27 disposed inside the bending portion 2b necessarily has a substantially arc shape.
- the plane 51 including the longitudinal center axis of the insertion channel 27 is substantially flush with the ultrasonic observation surface 10A.
- 16A to 16C show a state in which the insertion portion 31 of the ultrasonic puncture needle 30 including the needle tube 34 bent in a smooth arc shape in the vicinity of the distal end is passed through the curved insertion channel 27 as described above. Are shown in chronological order of operation.
- the distal end of the insertion portion 31 is pushed forward to the bending portion of the insertion channel 27 of the ultrasonic endoscope 1.
- the arc shape of the needle tube 34 reaches the curved shape of the insertion portion 2 as shown in FIG. 16B.
- the needle tube 34 receives a force from the inner wall of the insertion channel 27 by insertion, the arc shape of the insertion channel 27 and the arc shape of the needle tube 34 are located on the same plane (including substantially the same plane).
- the needle tube 34 is rotated about the longitudinal axis.
- the plane 34 b including the longitudinal center axis of the needle tube 34 that is, the plane including the axis line corresponding to the opening direction of the needle tube 34
- the plane 34b is substantially flush with the ultrasonic observation surface 10A.
- FIG. 16C shows a state where the insertion portion 31 has reached a predetermined position.
- the angular position around the axis of the needle tube 34 is the same as in FIG. 16B, the overlapping length of the arc shape of the needle tube 34 and the curved shape of the insertion portion 2 increases, so the angular position around the axis of the needle tube 34 is more stable.
- the direction A1 for viewing the opening 34a in the maximum area is substantially parallel to the plane 34b
- the direction A1 is substantially parallel to the ultrasonic observation surface 10A.
- the axis that matches the direction of the opening of the needle tube 34 is substantially parallel to the ultrasonic observation surface 10A.
- the implant 35 is elastic and is stretched when stored in the needle tube 34. As shown in FIG. 17, when the implant 35 is delivered from the opening 34a of the needle tube 34, it tries to return to its original shape from the stretched state. For this reason, it is sent out while being rubbed to the point 34d closest to the base end of the opening 34a. At this time, the implant 35 is sent out on the plane 34e. At this time, the plane 34e is substantially the same as the plane 34b and includes a base end point 34d.
- the implant 35 can be suitably confirmed on the ultrasonic image.
- FIG. 18 shows that the insertion portion 31 of the ultrasonic puncture needle 30 including the needle tube 34 bent in the shape of a smooth arc in the natural state is passed through the curved insertion channel 27 so that the insertion portion 31 is predetermined. It has reached the position.
- the insertion channel outlet 24 ′ has an angle with respect to the longitudinal axis direction of the distal end hard portion 2 a ′ so that the derived treatment instrument does not come into contact with the enlarged ultrasonic transducer portion 10 ′. It is tilted by ⁇ .
- the bending portion 2b of the endoscope insertion portion 2 is bent in a direction called a normal up direction.
- the lumen formed by the insertion channel outlet 24 ′ and the insertion channel 27 can smoothly pass through the needle tube 34 bent in an arc shape. Therefore, when the implant 35 is delivered from the opening 34a of the needle tube 34, the implant 35 can be suitably confirmed on the ultrasonic image.
- FIG. 19 is an overall external view of an ultrasonic puncture needle.
- FIG. 20 is an overall sectional view of the ultrasonic puncture needle.
- An injection cylinder 52 is attached to the resin cap member 43.
- the injection cylinder 52 includes a cylinder base 52a, a cylinder 52b, and a piston 52c, and a gas or liquid medicine 53 is loaded in the cylinder 52b.
- the mechanism by which the angular position around the axis of the needle tube 34 is controlled is the same as in the first embodiment, and will not be described.
- the medicine 53 is released from the opening 34a into the body via the lumen of the needle tube 34, so that the medicine 53 is released onto the ultrasonic observation surface 10A. Therefore, it can be suitably confirmed on the ultrasonic image that the medicine 53 is delivered.
- the substance to be delivered into the body may be a solid material such as the implant 35 or a gas or liquid medicine 53.
- the configuration other than the tip of the needle tube is the same as that in the first embodiment when a solid object is sent out.
- the configuration other than the tip of the needle tube is the same as in the second embodiment.
- the tip of the needle tube 54 is sharp, and an opening 54a is provided on the side surface.
- the direction in which the opening 54a is viewed from the front that is, the direction in which the opening 54a is viewed in the maximum area (shown by the arrow A2 in FIGS. 21A and 21C) is substantially parallel to the plane 54b including the longitudinal center axis of the needle tube 54.
- the number of openings 54a is one in this example, but may be appropriately provided in accordance with the range in which the drug is desired to diffuse. For example, another opening may be provided at a position opposed to 180 degrees.
- a plurality of openings may be arranged in the longitudinal direction of the needle tube 54.
- a general ultrasonic puncture needle may be subjected to ultrasonic reflection processing in order to improve the visibility of a needle tube on an ultrasonic image.
- ultrasonic reflection processing a large number of fine concave portions such as dimples are formed on the surface of the needle tube, or the surface is roughened.
- the ultrasonic reflection processing is configured such that the ultrasonic reflection mode is different between the vicinity of the opening 54a and the distal end side and the proximal end side of the opening 54a. Specific examples of such ultrasonic reflection processing are shown in FIGS. 22A and 22B.
- ultrasonic reflection processing 57 is performed around the opening 55a of the needle tube 55. Before and after the opening 55 a in the longitudinal direction, an ultrasonic reflection process 56 having an ultrasonic reflectivity different from that of the ultrasonic reflection process 57 is applied.
- FIG. 22B the peripheral surface of the opening 58a of the needle tube 58 is not processed, and the ultrasonic reflection processing 56 is applied before and after the longitudinal direction of the opening 58a. Yes.
- the ultrasonic reflection processing formed before and after the longitudinal direction of the opening is not limited to the ultrasonic reflection processing 56 as long as the ultrasonic reflection mode is different from that of the periphery of the opening.
- the mechanism by which the angular position around the axis of the needle tube is controlled is the same as in the first embodiment, and a description thereof will be omitted.
- the substance to be delivered into the body may be a solid substance such as the implant 35 or a gas or liquid medicine 53.
- the configuration other than the tip of the needle tube is the same as in the first embodiment.
- the configuration other than the tip of the needle tube is the same as in the second embodiment.
- the outer diameter and the center of the lumen are eccentric, and an opening 60a is formed at the tip of the needle tube 60 shown in FIG.
- the opening 60a is viewed in the maximum area (indicated by an arrow A3 in FIG. 23) so that it is substantially parallel to a longitudinal section 60f including a line 60e connecting the thinnest wall portion 60c and the thickest wall portion 60d of the needle tube. Is provided.
- the needle tube 60 maintains a straight line shape (including a substantially straight line shape) in a natural state where no external force acts.
- the insertion portion 27 of the ultrasonic puncture needle including the needle tube 60 whose outer diameter and the center of the lumen are eccentric is passed through the insertion channel 27 of the curved ultrasonic endoscope.
- the needle tube 60 is rotated around the longitudinal axis so that the thinnest portion of the needle tube 60 is located inside the curve of the ultrasonic endoscope.
- a longitudinal section 60f including a line 60e connecting the thinnest and thickest portions of the needle tube 60 is substantially the same as the ultrasonic observation surface 10A. Therefore, the direction A3 in which the opening 60a is viewed in the maximum area is substantially parallel to the ultrasonic observation surface 10A. In this way, the delivered substance can be suitably confirmed on the ultrasonic image.
- the configuration of the needle tube is different from the first to fourth embodiments will be described as a fifth embodiment.
- the substance to be delivered into the body may be a solid substance such as the implant 35 or a gas or liquid medicine 53.
- the configuration other than the tip of the needle tube is the same as that in the first embodiment when a solid object is sent out.
- the configuration other than the tip of the needle tube is the same as in the second embodiment.
- the needle tube 61 shown in FIG. 25 is formed in a flat shape such as an ellipse, an ellipse, or a rectangle in cross section, and the direction in which the opening 61a of the needle tube 61 is viewed in the maximum area (indicated by an arrow A4 in FIG. 25) is.
- the needle tube is substantially parallel to the longitudinal section 61f including the flat-shaped minor axis central axis 61e.
- the short diameter side is The needle tube 61 is rotated around the longitudinal axis in a direction toward the center of curvature.
- the longitudinal section 61f including the short axis central axis 61e of the needle tube is substantially the same as the ultrasonic observation surface 10A. Therefore, the direction A4 in which the opening 61a is viewed in the maximum area is substantially parallel to the ultrasonic observation surface 10A. In this way, the delivered substance can be suitably confirmed on the ultrasonic image.
- the direction in which the opening 62a of the needle tube is viewed in the maximum area is substantially parallel to the longitudinal section 62d including the flat major axis direction 62c.
- the above-described implant 35 is accommodated in the needle tube 62. Since the implant 35 tries to return to the original shape in the needle tube 62, the implant 35 is accommodated in the lumen so as to stretch in the long diameter direction.
- the needle tube 62 has a certain degree of flexibility, and has a sufficient size to cause the needle tube 62 to bend by the force with which the implant 35 tries to return. Therefore, as shown in FIG. 28, the portion of the needle tube 62 in which the implant 35 is housed, that is, the vicinity of the tip of the needle tube 62 is bent so as to draw a smooth arc on the longitudinal section 62d. As a result, although the size of the arc-shaped region in the needle tube 62 depends on the size of the implant 35, the shape is substantially the same as the needle tube 34 shown in FIG.
- the implant 35 can be suitably confirmed on the ultrasonic image as in the first embodiment.
- the state in which the substance is sent out is matched with the ultrasonic observation surface of the ultrasonic endoscope by matching the angular position of the needle tube opening to the ultrasonic endoscope.
- an ultrasonic puncture needle capable of accurately sending a substance to a region of interest while preferably observing.
- the state in which the substance is delivered is superposed by matching the angular position of the opening of the needle tube with the ultrasonic observation surface of the ultrasonic endoscope.
- a substance can be accurately sent to a region of interest while being preferably observed with a sonic endoscope.
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Abstract
Description
本願は、2011年5月27日に米国に仮出願された米国特許出願第61/490676号に基づいて優先権を主張し、その内容をここに援用する。
物質が針管から送り出される様子を超音波画像上で確認するためには、物質が針管から送り出される方向を、超音波観測面と一致させなければならない。そのためには、穿刺針を超音波内視鏡の挿通チャンネルに挿通した状態で、針管上に設けられた物質を放出するための開口部を超音波観測面上に位置させる必要があるため、針管の軸周りの角度位置を規定する必要がある。しかし、超音波内視鏡は長く柔軟性のある挿入部を持ち、体内の目的部位に到達したときには挿入部は複雑な形状に屈曲した状態にある。従って、挿入部を通過した針管の軸周りの角度位置は、手元操作部からの操作で調整することは困難である。また、針管上に設けられた物質を放出するための開口部を、常に超音波観測面上に位置させることは困難である。このため、物質が送り出される様子を超音波内視鏡で観察できず、関心部位に正確に物質を送ることが困難な場合があった。
本発明の第一の態様に係る超音波用穿刺針は、シースと、操作部と、針管と、放出機構とを備え、超音波内視鏡と組み合わせて使用される超音波用穿刺針である。前記シースは、前記超音波内視鏡の挿通チャンネルに進退自在に挿通される。前記操作部は、前記シースの基端部に配置され、使用者が把持する把持部を兼ねる。前記針管は、前記シース内に挿通されて、先端領域に開口が形成され、体腔内組織に穿刺される。前記放出機構は、前記針管の基端側に備えられ、装填された物質を前記針管の前記開口から外部に放出させる。さらに、前記針管が前記挿通チャンネルの内壁から力を受けることによって、前記挿通チャンネルから突出された前記針管の前記開口の向きに一致する軸線が前記超音波内視鏡による超音波走査面と略平行になるように、前記挿通チャンネルの長手軸周りに回転される。
(第一の実施形態)
本実施形態の超音波用穿刺針は、超音波内視鏡と組み合わせて使用される。
図1ないし図4を用いて本実施形態の超音波内視鏡について説明する。図1は超音波内視鏡の構成を示す図である。図2は超音波内視鏡の先端部を示す斜視図である。図3は図2に示す先端部を正面から見た正面図である。図4は超音波内視鏡の先端部の斜視断面図である。
シース33は、柔軟性のあるチューブであり、挿入部31の最も外側に位置する。シース33の材質は、例えば、ポリエーテルエーテルケトンやポリエーテルサルホンやテフロン(登録商標)のような樹脂が好適である。あるいは、シース33の材質は、一般にフレキシブルシャフトと呼ばれる金属線、特にステンレス線をコイルばね状に巻いた金属が好適である。シース33の内腔には針管34が挿通されている。針管34と挿通チャンネル27の内面とが直接接触して針管34や挿通チャンネル27を傷めることを防ぐ。
操作部本体37は、樹脂部材で形成される。
スライダ38は、この操作部本体37に対して摺動自在に設けられる。スライダ38は、樹脂部材で形成されている。
超音波用穿刺針30の製造、出荷時には、切欠段部37bの平面部には固定ネジ39bの先端面が所定のトルクで当接される。このことによって、スライダ38は操作部本体37の基端側に配置される。
第一の実施形態では、固体のインプラントを体内に留置する場合について述べたが、これに代えて、気体または液体の薬剤を体内に注入する場合について、第二の実施形態として述べる。以下では、第一の実施形態と同一の構成である部分は省略し、異なる点のみ説明する。
針管34の軸周りの角度位置が制御される機序は、第一の実施形態と同様であるので説明を省略する。
針管の先端形状が、第一および第二の実施形態と異なる構成について、第三の実施形態として述べる。なお本実施形態においては、体内に送り出す物質は、インプラント35等の固体物でも、気体または液体の薬剤53等でもよい。本実施形態における超音波用穿刺針では、固体物を送り出す場合、針管の先端以外の構成は、第一の実施形態と同様である。また、本実施形態における超音波用穿刺針では、薬剤53等の気体または液体を送り出す場合、針管の先端以外の構成は、第二の実施形態と同様である。ここでは、第一および第二の実施形態と構成が異なる点のみ説明する。
本実施形態において、針管の軸周りの角度位置が制御される機序は、第一の実施形態と同様であるので説明を省略する。
針管の構成が、第一の実施形態ないし第三の実施形態と異なる例について、第四の実施形態として述べる。本実施形態においては、体内に送り出す物質は、インプラント35等の固体物でも、気体または液体の薬剤53等でもよい。本実施形態における超音波用穿刺針では、固体物を送り出す場合、針管の先端以外の構成は、第一の実施形態と同様である。また、本実施形態における超音波用穿刺針では、薬剤53等の気体または液体を送り出す場合、針管の先端以外の構成は、第二の実施形態と同様である。ここでは、第一の実施形態ないし第三の実施形態と構成が異なる点のみ説明する。
針管の構成が、第一の実施形態ないし第四の実施形態と異なる例について、第五の実施形態として述べる。本実施形態においては、体内に送り出す物質は、インプラント35等の固体物でも、気体または液体の薬剤53等でもよい。本実施形態における超音波用穿刺針では、固体物を送り出す場合、針管の先端以外の構成は、第一の実施形態と同様である。また、本実施形態における超音波用穿刺針では、薬剤53等の気体または液体を送り出す場合、針管の先端以外の構成は、第二の実施形態と同様である。ここでは、第一の実施形態ないし第四の実施形態と構成が異なる点のみ説明する。
針管の構成が、第一の実施形態と異なる例について、第六の実施形態として述べる。なお本実施形態においては、体内に送り出す物質は、インプラント35等の固体物である。したがって、針管の先端以外の構成は、第一の実施形態と同様であるので、異なる点のみ説明する。
2、31 挿入部
2a、2a’ 先端硬質部
2b 湾曲部
2c 可撓管部
3、32 操作部
3a アングルノブ
3d 処置具挿入口
4 ユニバーサルコード
5 内視鏡コネクタ
6 超音波ケーブル
7 超音波コネクタ
10、10’ 超音波振動子部
10A、10A’ 超音波観測面
21 先端面
22 観察窓
23 照明窓
24、24’ 挿通チャンネル出口
27 挿通チャンネル
30 超音波用穿刺針
32 操作部
33 シース
34、54、55、60 針管
34a、54a、55a、60a 開口
34b、51、34e 平面
34d 点
35 インプラント
36 スタイレット
36a ツマミ
37 操作部本体
37a フランジ部
37b 切欠段部
38 スライダ
39 ストッパ
39a ストッパ部材
39b 固定ネジ(ストッパネジ)
40 接続部
40a ネジ
40b 凹部
40c 先端接続部
41 Oリング
42 摺動配置部材
43 口金部材
44 ガイドパイプ
50 体内管腔組織
52 注射筒
52a シリンダ口金
52b シリンダ
52c ピストン
53 薬剤
56、57 超音波反射加工
60c 最薄肉部
60d 最厚肉部
60e 線
60f 断面
A1、A2、A3、A4、A5 方向
L2、L2’ 中心軸
L3、L3’ 中心線
Claims (15)
- 超音波内視鏡と組み合わせて使用される超音波用穿刺針であって、
前記超音波内視鏡の挿通チャンネルに進退自在に挿通されるシースと、
前記シースの基端部に配置され、使用者が把持する把持部を兼ねる操作部と、
前記シース内に挿通されて、先端領域に開口が形成され、体腔内組織に穿刺される針管と、
前記針管の基端側に備えられ、装填された物質を前記針管の前記開口から外部に放出させる放出機構と、を備え、
前記針管が前記挿通チャンネルの内壁から力を受けることによって、前記挿通チャンネルから突出された前記針管の前記開口の向きに一致する軸線が前記超音波内視鏡による超音波走査面と略平行になるように、前記挿通チャンネルの長手軸周りに回転される
超音波用穿刺針。 - 請求項1に記載の超音波用穿刺針であって、
前記針管は、自然状態において少なくとも先端付近の部分が滑らかな円弧形状に成形され、
前記針管の前記開口を最大面積で見る方向が、前記針管の前記円弧形状によって構成される平面と略平行である超音波用穿刺針。 - 請求項1に記載の超音波用穿刺針であって、
前記針管は、外径と内腔の中心が偏心しており、
前記針管の前記開口を最大面積で見る方向が、前記針管の最薄肉部と最厚肉部とを結ぶ断面と略平行である超音波用穿刺針。 - 請求項1に記載の超音波用穿刺針であって、
前記針管は、外径断面が扁平な形状に形成されており、
前記針管の前記開口を最大面積で見る方向が、前記針管の前記扁平な形状の短径方向の断面と略平行である超音波用穿刺針。 - 請求項1に記載の超音波用穿刺針であって、
前記針管は、自然状態において少なくとも先端付近の部分が滑らかな円弧形状に成形され、
前記針管の前記開口の最も基端側が、前記針管の前記円弧形状によって構成される平面上にある超音波用穿刺針。 - 請求項1に記載の超音波用穿刺針であって、
前記針管は、外径と内腔の中心が偏心しており、
前記針管の前記開口の最も基端側が、前記針管の最薄肉部と最厚肉部とを結ぶ断面上にある超音波用穿刺針。 - 請求項1に記載の超音波用穿刺針であって、
前記針管は、外径断面が扁平な形状に形成されており、
前記開口の最も基端側が、前記偏平な形状の短径方向の断面上にある超音波用穿刺針。 - 請求項1に記載の超音波用穿刺針であって、
前記針管の内腔の断面が、扁平な形状であり、
前記開口を最大面積で見る方向が、前記扁平な形状の長径方向と平行である超音波用穿刺針。 - 請求項1に記載の超音波用穿刺針であって、
前記針管の先端部表面には、反射エコーを得るための超音波反射加工が施されており、
前記超音波反射加工の態様が、前記開口周辺とその他の部位とで異なっている超音波用穿刺針。 - 請求項1~9のいずれか一項に記載の超音波用穿刺針であって、
前記先端領域は、先端を含む超音波用穿刺針。 - 請求項1~9のいずれか一項に記載の超音波用穿刺針であって、
前記先端領域は、先端付近を含む超音波用穿刺針。 - 請求項1~9のいずれか一項に記載の超音波用穿刺針であって、
前記物質は、気体を含む超音波用穿刺針。 - 請求項1~9のいずれか一項に記載の超音波用穿刺針であって、
前記物質は、液体を含む超音波用穿刺針。 - 請求項1~9のいずれか一項に記載の超音波用穿刺針であって、
前記物質は、固体を含む超音波用穿刺針。 - 請求項14に記載の超音波用穿刺針であって、
前記固体は、細長の弾性体を含む超音波用穿刺針。
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CN201280009098.6A CN103379872B (zh) | 2011-05-27 | 2012-05-24 | 超声波用穿刺针 |
EP12793122.8A EP2662036B1 (en) | 2011-05-27 | 2012-05-24 | Puncture needle for ultrasound |
JP2012553525A JP5302469B2 (ja) | 2011-05-27 | 2012-05-24 | 超音波用穿刺針 |
US13/685,224 US8657749B2 (en) | 2011-05-27 | 2012-11-26 | Ultrasonic puncture needle |
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- 2012-05-24 JP JP2012553525A patent/JP5302469B2/ja active Active
- 2012-11-26 US US13/685,224 patent/US8657749B2/en active Active
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WO2014125707A1 (ja) * | 2013-02-15 | 2014-08-21 | オリンパスメディカルシステムズ株式会社 | 生検システム |
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CN104486985A (zh) * | 2013-02-15 | 2015-04-01 | 奥林巴斯医疗株式会社 | 活检*** |
EP2957209A4 (en) * | 2013-02-15 | 2016-10-26 | Olympus Corp | BIOPSY SYSTEM |
US9839414B2 (en) | 2013-02-15 | 2017-12-12 | Olympus Corporation | Biopsy system |
EP2957209B1 (en) * | 2013-02-15 | 2019-04-10 | Olympus Corporation | Biopsy system |
CN103239203A (zh) * | 2013-04-26 | 2013-08-14 | 广州宝胆医疗器械科技有限公司 | 一种经皮经肝穿刺胆道镜 |
JP2016154876A (ja) * | 2013-12-12 | 2016-09-01 | オリンパス株式会社 | 超音波用穿刺針 |
US20160278809A1 (en) * | 2013-12-12 | 2016-09-29 | Olympus Corporation | Puncture needle for ultrasound endoscope |
WO2023136302A1 (ja) * | 2022-01-17 | 2023-07-20 | テルモ株式会社 | 穿刺針 |
WO2023234011A1 (ja) * | 2022-05-31 | 2023-12-07 | テルモ株式会社 | 穿刺針 |
Also Published As
Publication number | Publication date |
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EP2662036B1 (en) | 2015-07-01 |
EP2662036A1 (en) | 2013-11-13 |
CN103379872B (zh) | 2015-12-09 |
EP2848220B1 (en) | 2016-05-04 |
JP5302469B2 (ja) | 2013-10-02 |
JPWO2012165303A1 (ja) | 2015-02-23 |
EP2848220A1 (en) | 2015-03-18 |
CN103379872A (zh) | 2013-10-30 |
US8657749B2 (en) | 2014-02-25 |
EP2662036A4 (en) | 2014-04-23 |
US20130144164A1 (en) | 2013-06-06 |
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