Classifications

• • A—HUMAN NECESSITIES
  • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
  • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
  • A61B10/00—Instruments for taking body samples for diagnostic purposes; Other methods or instruments for diagnosis, e.g. for vaccination diagnosis, sex determination or ovulation-period determination; Throat striking implements
  • A61B10/02—Instruments for taking cell samples or for biopsy
  • A61B10/0233—Pointed or sharp biopsy instruments
  • A61B10/0266—Pointed or sharp biopsy instruments means for severing sample
• • A—HUMAN NECESSITIES
  • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
  • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
  • A61B10/00—Instruments for taking body samples for diagnostic purposes; Other methods or instruments for diagnosis, e.g. for vaccination diagnosis, sex determination or ovulation-period determination; Throat striking implements
  • A61B10/02—Instruments for taking cell samples or for biopsy
  • A61B10/0233—Pointed or sharp biopsy instruments
  • A61B10/0266—Pointed or sharp biopsy instruments means for severing sample
  • A61B10/0275—Pointed or sharp biopsy instruments means for severing sample with sample notch, e.g. on the side of inner stylet
• • A—HUMAN NECESSITIES
  • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
  • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
  • A61B10/00—Instruments for taking body samples for diagnostic purposes; Other methods or instruments for diagnosis, e.g. for vaccination diagnosis, sex determination or ovulation-period determination; Throat striking implements
  • A61B10/02—Instruments for taking cell samples or for biopsy
  • A61B10/0233—Pointed or sharp biopsy instruments
  • A61B10/0283—Pointed or sharp biopsy instruments with vacuum aspiration, e.g. caused by retractable plunger or by connected syringe
• • A—HUMAN NECESSITIES
  • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
  • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
  • A61B18/00—Surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body
  • A61B18/04—Surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body by heating
  • A61B18/12—Surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body by heating by passing a current through the tissue to be heated, e.g. high-frequency current
  • A61B18/14—Probes or electrodes therefor
  • A61B2018/1405—Electrodes having a specific shape
  • A61B2018/1407—Loop

Definitions

• the invention relates to a hollow surgical probe for minimally invasive tissue removal with an elongated hollow body with an opening in the region of the distal end of the hollow body for receiving tissue and with an electrically conductive ring-like or loop-shaped one that can be pulled out of the hollow body and applied to an RF voltage source Cutting element for the electrosurgical cutting of tissue in the vicinity of the distal opening of the hollow body.
• FNA fine needle aspiration
• true-cut needle biopsy Devices known as "fine needle aspiration” (FNA) or “true-cut needle biopsy” which have a fine needle which is introduced into a suspicious area of tissue and by means of which one or more tissue samples can be removed purely mechanically by means of a punching mechanism to examine this tissue histologically.
• tissue volumes that can be removed with these known needle probes are only very small and are therefore only suitable for diagnostic purposes. Due to the small volume of tissue that can be removed from a puncture, multiple punctures into the suspicious tissue area are often required, which can lead to cell spreading of malignant tumor cells. Furthermore, due to the small tissue volume, the accuracy of the histological tissue findings is not optimal.
• Surgical instruments are known from US Pat. No. 5,775,333 or US Pat. No. 5,782,795 which enable larger tissue volumes to be removed by multiple tissue removal from the same target area.
• a vacuum-assisted mechanical punch-cutting device is used, which reduces the number of punctures required and also - because of the larger tissue volume - also improves the accuracy of the diagnostic findings.
• even small tissue changes can often be removed in total, which can make a subsequent operation unnecessary.
• a needle-shaped hollow probe for example a breast tumor, is introduced. At the end of this probe there is an elongated opening on the side into which the tissue to be removed is sucked in.
• a rotating hollow knife which cuts off the tissue sucked into the opening within the device via a mechanical feed and sucks it off through the hollow probe by means of a vacuum.
• a certain tissue volume previously sucked into the hollow probe and cut off around the distal end of the probe is removed, but this is often not entirely sufficient for a complete removal of the medically suspicious tissue area.
• a surgical probe is known in which the tissue is cut not by means of a mechanical ring knife, but with the aid of an axially immovable loop fastened to the distal end of the hollow body, which is acted upon by an RF voltage and thereby acts as a cutting knife.
• the tissue cylinder which is circumferentially separated from the HF loop, pushes frontally into the frontally open hollow body, and is then separated at the end of the procedure by a windshield wiper-like rotary movement of the loop which is subjected to HF voltage.
• an electrosurgical device of the type mentioned at the outset in which a loop-shaped cutting element for the electrosurgical cutting of tissue is aligned parallel to the longitudinal axis of an elongated hollow body and in the shape of a loop while maintaining this alignment the hollow body can be extended so that the adjacent tissue can then be cut out in a toroidal shape by rotating the hollow probe.
• the cut-out tissue can then be introduced into the hollow channel of the hollow body through the same opening through which the cutting element exits and then transported along the hollow channel to the proximal end of the device.
• This known device has the advantage that the puncture site has small dimensions and that a tissue can then be removed at the treatment site, which surrounds the hollow probe on the outside.
• the tissue volume that can be cut out is relatively small and is therefore not sufficient for a thorough examination of even larger tissue areas.
• a loop-shaped cutting element which can be extended in a plane from the hollow body which extends transversely to the longitudinal axis of the hollow body, the cutting element being displaceable along the hollow body after the cutting element has been extended.
• the object of the invention is to develop the surgical probe of the type mentioned at the outset in such a way that, with a small diameter of the incision, a comparatively larger and coherent amount of tissue can be removed without having to remove substantial amounts of healthy tissue.
• This object is achieved according to the invention in a surgical probe of the type mentioned at the outset in that the cutting element can be extended or folded out of the hollow body transversely to the longitudinal axis of the hollow body and can then be displaced outside the hollow body parallel to the longitudinal axis of the hollow body.
• the cutting element can be moved radially out of the hollow body and then - by means of intermittent rotation of the hollow probe about its longitudinal axis - several tissue cylinders adjacent to the circumference of the hollow probe can be cut out, which can then be transported, for example via a suction device, through the distal opening into the hollow body and then to the proximal opening of the hollow body.
• a first cut perpendicular to the hollow probe when the cutting knife is extended radially then cut out the circumference of a first tissue cylinder lying outside the hollow probe when the cutting element is moved in the longitudinal direction of the hollow probe, and finally to cut off the tissue cylinder on the end face when the Hollow probe, and thus the cutting element is rotated about its longitudinal axis by a predetermined angle of rotation.
• a further tissue cylinder can be severed at its periphery and then - on the face side - also cut off on the face side by rotating the hollow probe again.
• a ring of parallel tissue cylinders can be cut out in this way, which adjoin the circumference of the hollow probe and are oriented parallel to the longitudinal axis of the hollow probe.
• the amount of tissue that can be removed in this way is composed of several individual tissue cylinders, each of which has approximately the same volume as the known surgical hollow probes (for example from US Pat. No. 5,810,806). can be won.
• the diameter of the puncture remains limited to the diameter of the hollow probe.
• the RF voltage required for cutting which is applied to the cutting element, generates an RF current, which flows in a known manner through the tissue to a counterelectrode, which is placed, for example, on the patient's skin from the outside or on the hollow body of the patient Hollow probe is arranged.
• the annular or loop-shaped cutting element is preferably extendable out of the hollow body in a plane or surface extending transversely to the longitudinal axis of the hollow body and then remains oriented perpendicular to the longitudinal axis during a cutting process, i.e. while the cutting element is being moved along the displacement path. In this way, with a given shape of the cutting element, the maximum tissue volume can be cut off with each cutting process.
• the distal opening preferably extends on the circumferential wall of the hollow body along the displacement path of the cutting element, so that when the hollow probe is slightly rotated, the cut tissue can then be easily introduced into the distal opening.
• the cutting element is designed as a wire loop or wire loop, the two ends of which are fastened together to a push rod or separately to a push rod, the push rods being slidably mounted in longitudinal grooves on the outer surface of the hollow body parallel to the longitudinal axis of the hollow body .
• the cutting element is designed as a closed wire ring, which is fastened on its outer circumference to a guide element, for example a push rod, which is displaceably guided in a longitudinal groove along the hollow body.
• the cutting element consists, for example, of a flexible wire which can be easily moved out of the hollow body and into it, for example through a slot in the peripheral wall of the hollow body.
• the cutting element is connected to an RF voltage source, which is located at the proximal end of the hollow probe, via a connecting line which is guided, for example, along the inner wall of the hollow body.
• the other connection of the RF voltage source is connected to a counter electrode, which is either placed on the patient's skin from the outside or - to prevent uncontrolled flow of current through the tissue - is located on the hollow body or is part of the hollow body. If the hollow body is made of metal, the entire hollow body of the hollow probe can also serve as a counter electrode, which results in a controlled, locally narrowly limited current flow from the cutting element to the counter electrode. However, these are then both to be electrically insulated from one another to avoid a short circuit.
• the distal opening is located in the distal region in the peripheral wall of the hollow body, adjacent to the longitudinal grooves in which the push rods are guided so as to be longitudinally displaceable.
• the distal opening is preferably delimited by wall edges which run parallel to the longitudinal groove or the longitudinal grooves.
• the clear width of the distal opening is preferably greater in the axial direction than the maximum axial displacement path, so that the cut-out tissue cylinders can easily be conveyed through the distal opening into the hollow body and into the proximal end of the hollow probe.
• the cutting element is designed as a wire loop, the two ends of which are guided in two spaced-apart longitudinal grooves on guide elements or push rods
• the distal opening can preferably be provided on the circumference of the hollow body between the two longitudinal grooves. The cut tissue cylinder can then be transported into the cavity of the hollow body without rotation of the probe.
• the cutting element can also be composed of a plurality of wire segments which are fastened to push rods offset from one another in the longitudinal direction of the hollow body, the push rods in longitudinal grooves along the Hollow body are guided.
• the wire segments are shaped such that their projection onto a plane perpendicular to the longitudinal axis forms a closed curve together with the peripheral wall of the hollow body, all wire segments then being connected to one connection of the HF voltage source, and the counter electrode in the usual way, the hollow body or a separate outer counter electrode.
• At least one of the push rods which can be displaced in the longitudinal grooves is preferably rotatably mounted in the relevant longitudinal groove, and at the distal end and / or at the proximal end of the displacement path there is a gap in the circumferential direction in the hollow body, through which the cutting element moves out of the hollow body, when the push rod to which the cutting element is attached is rotated accordingly.
• the distal opening of the hollow body can preferably be closed by means of a closure, in order not to hinder the insertion of the probe into the tissue and to prevent, after the cut-out tissue cylinder has been sucked in, that non-cut-off tissue adjacent to the proximal end is transported into the opening by vacuum is sucked.
• the closure is preferably slidable in the radial and / or axial direction along the peripheral wall of the hollow body, for example the closure can be realized by a rotating sleeve which is rotatably mounted in the interior of the hollow body and also has a distal opening which is in register with the distal one Opening of the hollow body can be brought.
• a suction device can be connected proximally to the hollow probe, which contains a separate suction air channel in the longitudinal direction of the hollow probe, which extends from the proximal connection to the distal opening of the hollow body and with the hollow channel of the hollow body is in suction connection via suction openings.
• the distal end of the hollow probe tapers and carries a first electrode, which can serve as a counter electrode for the cutting element when cutting out tissue.
• one connection of the HF voltage source is connected to the cutting element, the other connection to the first electrode.
• the first electrode is particularly preferably subjected to RF voltage during the piercing process, and a counter electrode is placed on the patient in the vicinity of the tissue area to be examined from the outside.
• the tissue adjacent to the probe is then thermally inactivated by means of a locally limited, high-frequency alternating current over a period that can be individually specified.
• a second electrode is applied to the hollow body at a predetermined axial distance, the high-frequency alternating field between the two - preferably cylindrical electrodes - can be generated, whereby the alternating field - when the probe is inserted - is locally limited to immediately adjacent tissue zones.
• the counter electrode fitted from the outside can then be omitted.
• the RF voltage is determined in such a way that temperatures between 55 ° and 100 ° C., preferably between 60 ° and 80 ° C., are held in the tissue over a longer period of time, for example 5 to 20 minutes, so that the metabolic processes within the tumor cells to end irreversibly. This thermal inactivation ensures that the tumor cells can no longer spread and metastasize during the subsequent tissue removal.
• a plurality of cutting elements can be moved out of the hollow body transversely to the longitudinal axis of the hollow body and can then be displaced in the longitudinal direction outside the hollow body.
• Each cutting element is preferably assigned a distal opening on the peripheral wall of the hollow body, which extends along the displacement path of the cutting elements in question.
• Figure 1 is a perspective view of a first embodiment of a hollow surgical probe
• FIG. 2 shows a partial view of the hollow probe according to FIG. 1;
• FIG. 3 shows a perspective view of a second embodiment of the hollow surgical probe
• Figure 4 shows a cross section along the line III-III of Figure 3;
• FIG. 5 shows a perspective view of a third embodiment of the hollow surgical probe
• Figure 1 1 is a schematic view of the operation of the hollow probe according to Figures 1 to 10.
• Figures 1 to 6 show different embodiments of a hollow surgical probe, which is used for minimally invasive removal of tissue from the human or animal organism.
• the hollow probe 1 contains a cylindrical hollow body 2 with a uniform circular cross section, which has a tip 6 at its distal end 4 and various actuating devices (not shown) at its proximal end (various actuators) for actuating the elements of the hollow probe as well as connections for connecting supply sources, for example vacuum devices or an RF voltage source.
• the hollow body 2 has a central longitudinal axis 3 and an inner hollow channel 8 which extends from the distal region 4 to the proximal region of the hollow probe 1 and forms a transport path for tissue parts which are cut off in the vicinity of the distal region and transported to the proximal end of the hollow probe 1 should be.
• a longitudinal groove 16 is incorporated on the peripheral surface of the hollow body 2, in which a guide element, for example a push rod 14, is mounted so as to be longitudinally displaceable.
• the push rod 14 extends to the proximal end of the hollow body 2 and can be displaced there by the surgeon by means of actuating devices (not shown).
• the cutting element can be moved together with the push rod 1 4 along the hollow body 2, it lies in each case in a plane which intersects the longitudinal axis 3 perpendicularly.
• a gap 18 is machined into the peripheral wall of the hollow body 2 in the circumferential direction.
• the push rod 1 4 is also rotatably mounted in the longitudinal groove 1 6 in addition to its displaceability, so that the cutting element 1 0 - upon reaching its distal end position - is rotated by rotation of the push rod 14 through the gap 1 8 into the hollow channel 8 of the hollow body 2 or can be moved out of the hollow body 8 through the gap 1 8 in this distal end position.
• distal opening 20 in the peripheral wall of the hollow body 2, which extends along the displacement path of the cutting element 10 and - in the embodiment shown - is delimited by longitudinal edges is, which run parallel to the longitudinal groove 1 6.
• the distal opening 20 is further delimited in the embodiment shown by wall edges which run parallel to the gap 1 8, ie in the circumferential direction, perpendicular to the longitudinal groove 1 6.
• RF voltage from an RF voltage source that can be connected to the proximal end of the hollow probe 1 can be applied to the cutting element 10 via connecting lines that are guided, for example, on or in the push rod.
• the other connection of the HF voltage source is connected to a counterelectrode, which can be arranged, for example, on the hollow body 2, insulated from the cutting element 10, or can be placed as a separate electrode from the outside onto the tissue area to be treated.
• FIGS. 3 and 4 largely corresponds to the embodiment according to FIGS. 1 and 2, the same reference numbers denoting the same parts.
• a first metallic electrode 30 is applied to the distal tip 6 of the hollow body 2 in FIGS. 3 and 4, which covers the entire tip 6 and an axial section of the hollow body 2 adjoining it.
• a second metallic electrode 32 which has a cylindrical shape, is arranged at a predetermined distance from the first electrode 30, namely at the proximal end of the longitudinal groove 16 and the distal opening 20.
• the distal opening 20 can be displaced by means of an axially displaceable closure 22.
• a suction air duct 40 is provided along the hollow body 2 and is in suction connection with the hollow duct 8 of the hollow body 2 via suction openings 42.
• the second electrode 32 is either arranged directly on the hollow body 2 and then has a fixed axial distance from the first electrode 30. Alternatively, however, the second electrode 32 is located on a sleeve 34 which is slidably mounted on the hollow body 2, so that at a displacement of the sleeve 34, the axial distance between the electrodes 30 and 32 is variable.
• the electrodes 30, 32 preferably have a cylindrical shape and run around on the outer circumference of the hollow body 2 or the sleeve 34.
• FIGS. 5 and 6 show a hollow surgical probe 1, which in its Corresponds to basic elements of the embodiment according to FIGS. 1 to 4 and also has a circular cylindrical hollow body 2 with a distal tip 6, a longitudinal axis 3 and a hollow channel 8.
• the cutting element 10 is designed as a wire loop, the two ends 12 of which are each fastened to a push rod 14.
• the push rods 14 are slidably mounted in parallel longitudinal grooves 1 6. Between the two longitudinal grooves 16 there is the distal opening 20 which is delimited by wall edges which run parallel to the longitudinal grooves 16.
• the distal opening 20 can be closed by a closure 22, which is mounted on the inner surface of the hollow body 2 so as to be displaceable in the circumferential direction.
• the two longitudinal grooves are connected at their distal end by a slot 1 8, which runs perpendicular to the longitudinal grooves 1 6 and the longitudinal axis 3 and serves to ensure that the cutting element 10, which can be made of flexible wire, can be inserted into the hollow channel 8 is extendable from the hollow channel 8.
• the cutting element 10, also referred to as a ring electrode can either be made of a solid, preformed metal ring, e.g. made of stainless steel or made of a flexible electrode material, e.g. a stainless steel wire mesh, or a wire made of a NiTi alloy.
• the cutting element With a flexible design of the cutting element 10, the cutting element can be folded up inside the hollow body 2 in the retracted state, it can be unfolded when extended and can have a diameter in the extended state that is larger than the diameter of the hollow body 2. If the flexible cutting element 10 has sufficient elasticity, the cutting element 10 can fold out of itself in the tissue to its original diameter due to the material prestress.
• the ring-shaped or circumferential cutting element 10 is fastened vertically at least at one point with a push rod 14, which can also be designed as a thin tube and in this way can accommodate the electrical supply line for the cutting element 10 which can be subjected to HF voltage.
• the hollow probe 1 For minimally invasive tissue removal using the hollow probe 1, the hollow probe 1 is first placed by inserting it into the tissue area in question.
• an HF voltage is applied between the electrodes 30, 32 running cylindrically around the hollow body 2, or between one of these electrodes and an outer counter electrode.
• the frequency and amplitude of this HF voltage are such that local heating between 55 ° and 100 ° C., preferably between 60 ° and 80 ° C. for inactivating the cell metabolism takes place in the tissue adjacent to the hollow probe 1, without doing so however, to destroy the cell and tissue matrix. This took place after a predetermined time of approximately 5 to 20 minutes, whereupon the voltage application to the two electrodes 30, 32 is ended.
• This treatment precoagulates the puncture channel and also the target area, thereby inactivating and solidifying the adjacent cells, so that any tumor cells are not carried over mechanically.
• the cutting element 10 can then be moved out of the hollow body 2 via an electromechanical actuating device until the cutting element is fully extended.
• the surface formed by the cutting element 10 is perpendicular to the longitudinal axis 3 of the hollow body 2.
• an HF voltage is applied to the cutting element 10 and a counter electrode, which is applied to the hollow body 2 or from the outside to the relevant one Tissue area is placed.
• the cutting element 10 is then operated as an HF cutting electrode.
• the annular cutting element 10 can be moved out of the hollow body 2 through the gap 18, cf. FIG. 7 and FIG. 8.
• the cutting element 10 can then be displaced along the longitudinal groove 16 by a translational movement, cf. FIG. 9 and FIG. 10. If, during this movement cycle, the cutting element 10 is subjected to HF voltage with a predetermined frequency and strength, the Cutting elements 10 the end face, and then cut out a lateral surface of a fabric cylinder during the longitudinal displacement. If the probe is then rotated about its longitudinal axis 3 when the cutting element 10 is extended, the tissue cylinder on its other end face is also cut off because the cutting element 10 is inevitably rotated when the hollow probe 1 rotates.
• the distal opening 20 still closed by the closure 22 slides under the tissue cylinder which has now been completely cut out.
• the cut tissue cylinder - after opening the closure 22 - can be passed into the hollow channel 8 and through the hollow channel 8 via a vacuum flow, and at the proximal end of the hollow probe 1 be removed by the user.
• tissue cylinders can be passed through the distal opening 20 due to the elastic behavior of the biological tissue.
• the cutting process can then be continued to obtain a further tissue cylinder.
• the ring-shaped cutting element 10 is pushed back to the distal tip 6 and, because of the applied HF alternating voltage, cuts out a further tissue cylinder 5, which - like the first tissue cylinder 15 - outside the hollow probe parallel to its longitudinal axis 3 runs.
• the distal end face of the tissue cylinder 15 is separated from the cutting element 10, the distal opening 20 is pushed again under the cut tissue cylinder 15, which can be passed through this opening 20 to the user .
• the tissue cylinders 15 located adjacent to the hollow probe 1 5 can be separated and removed one after the other precisely by electrosurgery. These tissue samples can then be subjected to a pathological tissue examination (histology). This procedure can be repeated until the starting position is reached again - after rotating the hollow probe 1 by 360 °, cf. Figure 1 1. As a result, the user removes a tissue volume that corresponds to a multiple of the diameter of the hollow probe 1.
• the method of operation of the hollow probe 1 according to FIGS. 5 and 6 is carried out in exactly the same way as that described for the embodiment according to FIGS. 1 to 4, but no rotation of the hollow probe 1 about its longitudinal axis 3 has to be returned in order to separate the respective tissue cylinders .
• the cutting element 10 is always moved out of the hollow probe 1 in order to carry out an end face cut, then a longitudinal displacement of the cutting element 10 takes place, and then the cutting element 10 is retracted into the hollow probe 1 again to make the other end face cut. Since the distal opening 20 lies immediately below the cut-out tissue cells, the closure 22 is opened and the tissue cylinder is transported away through the opening 20. Only to cut out an adjacent tissue cylinder is the probe rotated and the cutting element 10 moved out of the hollow probe again, etc.

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• Health & Medical Sciences (AREA)
• Life Sciences & Earth Sciences (AREA)
• Medical Informatics (AREA)
• Engineering & Computer Science (AREA)
• Biomedical Technology (AREA)
• Heart & Thoracic Surgery (AREA)
• Pathology (AREA)
• Molecular Biology (AREA)
• Surgery (AREA)
• Animal Behavior & Ethology (AREA)
• General Health & Medical Sciences (AREA)
• Public Health (AREA)
• Veterinary Medicine (AREA)
• Surgical Instruments (AREA)

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• 2000
  • 2000-04-08 AU AU45456/00A patent/AU4545600A/en not_active Abandoned
  • 2000-04-08 JP JP2001504292A patent/JP2003502094A/ja active Pending
  • 2000-04-08 WO PCT/EP2000/003146 patent/WO2000078221A1/de active Application Filing
  • 2000-04-08 EP EP00926844A patent/EP1408839A1/de not_active Withdrawn
  • 2000-04-08 US US10/018,154 patent/US7601125B1/en not_active Expired - Fee Related

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