WO1981001648A1

WO1981001648A1 - Device for effecting a sampling of a conical shaped fragment of tissue of the cervix uteri

Info

Publication number: WO1981001648A1
Application number: PCT/DE1980/000182
Authority: WO
Inventors: J Schwarze; R Kortlaender
Original assignee: J Schwarze; R Kortlaender
Priority date: 1979-12-07
Filing date: 1980-12-08
Publication date: 1981-06-25
Also published as: DE3070905D1; EP0041963A1; DE2949278C2; EP0041963B1; DE2949278A1

Abstract

Device for effecting a sampling of a conical shaped fragment of the cervix uteri tissue by means of a blade (61) shaped as a flexible ribbon. The blade has one end which is appropriate for insertion into the channel (M) of the cervix uteri and carrying a cutting rod (48) which may be imparted with a reciprocating radial motion. At the other end, the blade has a retainer (65) extending radially of the axis of the cutting rod, also appropriate to effect a reciprocating axial motion, radial pivoting and torsion along its axis. Thereby, the blade (61) executes first a radial cutting motion and then, at the end of said motion, a circular conical travel so as to separate the desired conical fragment. The blade (61), excepting its cutting edge, is surrounded by a sheath (62) having the shape of a flexible sleeve of synthetic material. For the electro-cauterization, a current lead (72) may be housed in the sheath (62) and connected to a projecting piece (75) in contact with the body and acting only on the outer side of the cut, so as to produce a thermo-coagulation only on the remaining portion of the tissue.

Description

Device for coning the knife of the cervix

Technical field

The invention relates to a device for knife conization of the cervix, with a band-shaped flexible knife which can be changed in position in the radial direction. In the

Knife conization of the cervix is a method for taking a tissue sample from the cervix to determine possible pathological changes and at the same time for the therapeutic elimination of pathological tissue on the cervix.

State of the art

In a known device of the type specified above (US Pat. No. 3,613,662) is on rotatable rod for insertion into the cervix, a radially projecting arm is attached, and the knife extends from the front end of the rod over the arm to up to two brackets which are fastened to a pistol-like handle near the rear end of the rod. In this case, the knife must be brought into a certain fixed position before the operative intervention, which fixes the radius of the cone to be cut out. There are three slots available for three different radii. The ends of the knife always remain firmly clamped, ie the basic position of the knife cannot be changed, and only the course of its middle section can be more or less curved. This is associated with the disadvantage of a bulbous biopsy, which leads to the fact that, during conization, tissue is also removed from the muscle, from which no tissue samples are supposed to be taken. In addition, there is a risk that the known device also opens the larger blood vessels in the lateral cervical area, with which corresponding bleeding is associated.

In a further known device (US Pat. No. 3,345,981), which is designed as a hand-held device without its own drive, the front end of the knife sits at the front end of a stylus rod, from where the knife runs at a non-adjustable angle to a radially projecting knife holder, to which it is attached by means of a clip. This has the disadvantage that the surgeon needs both hands in order to carry out the necessary pricking and cutting movements.

'OMPI In another known instrument for conization of the portio, the knife is rigidly held in a certain cone angle, so that the tissue sample to be removed is adapted to the individual in terms of its shape and size

Expansion of the tissue changes on the surface of the cervix is not possible.

While the known devices described so far for carrying out the so-called cold conization are designed, devices for so-called electrical conization also belong to the prior art, in which the cone to be examined on the cervix is removed with a high-frequency glow wire instead of a cutting knife (high-frequency caustic) . However, this method is histologically unsatisfactory because of the associated thermal coagulation of the cutting edges, because it cannot be seen with certainty whether healthy or pathological tissue has been cut. This area also includes a surgical instrument for the conization of the cervix (DE-OS 23 09 205), with which a cone is released from the portio, the cutting edges of which are heat-denatured, that is, overcooked or charred. A maneuverability in relation to the side

There are no excision margins during coning.

Presentation of the invention

In view of the described prior art, the invention has for its object to provide a fully mechanized and largely automatically working device with which

OMPI Contrary to the known devices, histologically meaningful and thus therapeutically satisfactory tissue samples of individually determined cone shape and size can be obtained with regular certainty. The knife conization as such should also be able to be used more frequently to really completely remove the tissue changes due to much easier handling.

The inventive solution to this problem, including advantageous refinements and developments, results from the patent claims preceding this description.

The proposals according to the invention have numerous advantages. In particular, the cervical canal can always be assumed during the procedure, in that first a radial incision movement is carried out from there, which at its outer end changes into a conical circular movement. In all cases, this enables comparatively symmetrical conical samples, which among other things prevents increased bleeding by cutting away more distant blood vessels. Because of the invention, the whole conization is also done particularly gently, because tugging and tearing movements are excluded. Due to the high-frequency caustic provided on one embodiment of the invention exclusively on the outside of the separating knife, the cut surface of the tissue part remaining in the patient's body can be sealed to prevent bleeding and a sample can nevertheless be obtained for examination, the cut surface of which in turn is not coagulated and thus histological can be properly evaluated.

OMP Brief description of the drawings

The drawing shows two exemplary embodiments of the invention, which are described below. Show it:

1 is a diagrammatic-schematic side - inside view of the device,

1a is a side view of the front part of the device carrying the knife,

2 shows a section along line II-II in FIG. 1a,

3 shows an axial longitudinal section through the knife end of the device,

4 shows an enlarged section along line IV-IV in FIG. 2,

5 the cervix with the cut-out cone in a diagrammatic representation,

6 - 9 the process of conization using four different knife positions on the cervix,

10 is a diagrammatic side view of a second exemplary embodiment of the device, specifically corresponding to FIG. 1, left part, and FIG. 1a,

- £ JREA

OMPI b

11 shows a section along line XI-XI in FIG. 10,

12 shows a side view of the front knife bearing in the embodiment for electro-caustic,

13 is a plan view of the subject of FIG. 12,

14 shows a cross section along line XIV-XIV in FIG. 13.

Two ways of carrying out the invention

FIGS. 1 and 1a can only be understood in connection with one another, since the shaft ends of the front part of the device shown in FIG. 1a are integrally connected to the shaft stubs protruding from the housing shown in FIG. 1 (above). The device as such is in the form of a pistol. An electric, pneumatic or other suitable drive motor 2 with a reduction gear 3 is accommodated in the pistol grip 1. The high-frequency motor 2 rotating here at 7000 revolutions per minute can be connected to a mains socket via a switch 4, 5 and a power supply cable 6. The gear 3 reduces the motor speed in the ratio 60: 1. The gear shaft 7, which therefore rotates at 116.6 revolutions per minute, is connected by means of a coupling 8 to a drive shaft 11 leading into the gun housing 9 up to a bearing 10. On this sits a gear 12 which meshes with a gear 13 of the same size, ie in a ratio of 1: 1, which sits on a crankshaft 16 rotating in the end bearings 14 and 15. A connecting rod 18 engages on the crank 17 and is connected by means of a fork joint 19 to a stylus rod 21 which leads to the device head and is guided there through a bearing 20.

On the crankshaft 16 sits between the crank 17 and the end bearing 15, a gear 22 which is smaller than the gear 13 seated on the same crankshaft 16 and with a gear 23 of the same diameter as the gear 13, i.e. reducing, on a parallel to the crankshaft 16 in combs the end bearings 24 and 25 extending shaft 26. On the shaft 26 there is a worm 27 which is seated in a shaft 28 which leads to the device head

Worm gear 29 engages. The shaft 28 runs at the rear in a final bearing 30 and protrudes through a bearing 31 at the front in order to engage a shaft 34 leading to the device head by means of a lever 32 which can be engaged and disengaged by hand by actuating a lever 32 which projects laterally from the gun housing 9 ¬ close. A gear 35 sits on the front end of this shaft 34 _.

At the bottom of the _. Gun housing 9 is located - to a certain extent as a gun trigger - from the index finger of the gun handle 1 holding it

Hand of the surgeon to be more comprehensive, with concave

Attack rounding 36 provided bolt 37 which engages with an upper horizontal, in the longitudinal direction of the gun housing 9 rack 38 in this and there with a guer to

Gun housing 9 mounted on a shaft 39

Gear 40 meshes. Sitting on the same shaft 39 a gear 41 of larger diameter than the gear 40. The gear 41 engages - that is to say with a step-down gear - in a rod 42, which extends parallel to the rack 38 and also has a rack-like design on its underside and protrudes from the front of the device head. Against the rear end of the rack 38, a return helical spring 43, which is mounted in the gun housing 9, is supported. The latch 37 to be operated like a trigger tap has one against the spring 43

30 mm stroke. He pushes with the underside of his rear end over the resiliently depressible current switch pole 4, which sits on the fixed opposite pole 5 and closes the circuit between the supply cable 6 and the electric motor 2.

The parts of the device to be inserted into the vagina can be removed from the device head for cleaning and disinfection and can be plugged onto it by means of a cap 44. In the device head 45 receiving the cap 44 there is a chamber 46 into which the stylus rod 21 extends through the bearing 20. It ends in it with a resilient plug-in sleeve 47, in which the rear end of the stylet rod 48 to be inserted into the sheath detachably engages with a ball head 49. The stylus rod 48 is surrounded by a coaxial tube 50 which projects through a bearing in the middle of the cap 44 with a wedged cylindrical bush 52 into the chamber 46. On the outer circumference of its rear part, the bushing 52 has ring teeth 53 with which the gear 35, which is smaller in diameter and which sits on the front end of the shaft 34, meshes. It runs

OMPI the tube 50 at 3 revolutions per minute clockwise.

The tube 50 is surrounded by an axially parallel tube 55, at the rear end of which sits a flange 56 which rotatably engages in the groove 57 of a claw 58 seated at the front end of the rod 42. To release the part of the device to be inserted into the vagina, the claw 58 is fixed with a pin 59 which engages and retracts radially into the rod 42, that is to say can be stripped off the rod 42, so that the flange 56 of the tube 55 is then released.

The front end of the tube 50 to be inserted into the cervix M of the cervix H ^* (FIG. 5) overlaps the stylus rod 48 with a cap 60 which at the same time carries the front end of a band-shaped knife 61 (FIG. 3). The 70 mm long knife 61 is flexible and, except for its cutting edge, is encased in a plastic jacket 62 (FIG. 4) which is intended to guide the knife during its short-stroke and fast cutting movement. At the rear end of the knife sits a ball head 63 which is slidably guided in a corresponding dovetail-shaped groove 64 on the end face of a crescent-shaped slide 65 (FIG. 2). The slide 65 sits radially projecting outside on the front area of the tube 55. To compensate for the length when the knife 61 is bent, its rear end is guided by means of an axial longitudinal groove 66 on a pin 67 inserted through the plastic jacket 62. A driver pin 68 projects radially from the circumference of the inner tube 50 and engages in a control link 69 in the enveloping outer tube 55. The

_O PI_ The backdrop 69 consists of a guide channel 70 which runs obliquely to the axis of the tube 55 and has a rectangular cutout 71 which adjoins the rear (FIG. 1a). Their mode of action is described in the following description

Operation and operation of the device explained

When the device is inserted with the cap 60 first into the cervical canal, the entire length of the knife 61 lies almost parallel to the outer tube 55 carrying the slide 65. The driver pin 68 is located at point A of the control link 69. The clutch 33 is disengaged by actuating the lever 32, so that the shaft 34 and thus also the inner tube 50 stand still. After switching on the motor 2 by tapping on the curve 36 of the bolt 37 and thus closing the switch 4, 5, the rod 21 and thus its continuation, the rod 48, on which the front end of the knife 61 sits, thanks to the rotating crank mechanism 17 a short-stroke back and forth, so prick movement. At the same time, when the bolt 37 is tapped and the rod 42 moves forward, the outer tube 55 slides forward with the slide 65 (FIG. 1), as a result of which the knife 61 with its rear ball head 63 swings radially in the slide groove 64 (FIG. 1a ). The outer tube 55, which has been shifted forward, has rotated a quarter turn clockwise as a result of sliding of the driving pin 68 in the guide channel 70 of the control link 69 up to the position B in the rectangular cutout 71. A straight radial incision D (FIGS. 5 and 6) of the knife 61 in the cervix H has been made.

- £ ÜRE OM Now clutch 33 is engaged and inner tube 50 begins to rotate clockwise. The front end of the knife 61 makes a quarter turn. Only then does the driver pin 68 in position C in the rectangular one

Recess 71 of the control link 69, the outer tube 55 The long flexible band knife 61 has twisted around its longitudinal axis in its entire rear area, which is suitable for the cut, so that after a previous radial movement into the

Circular movement is pivoted in and performs the circular cutout E of the tissue cone with synchronous rotary movement of both tubes 50 and 55. The knife 61 thus runs, so to speak, behind its guidance on the movable ball head rear end 63 in the groove 64 of the slide 65 (FIGS. 7-9). In FIG. 7, the knife 61 has just started its circular path E 'briefly. In FIG. 8, it has covered about a quarter E ¹ 'of it, and in FIG. 9 it has covered about three quarters E'' ^{1 of} its circular path until the tissue cone is finally cut out (FIG. 5).

FIGS. 10-14 represent a second exemplary embodiment of the knife configuring device, specifically this device is set up for electro-caustics by introducing electrical current into the knife sheath 62, for which purpose a current guide rail 72 is embedded in it, which is connected via a electrical line 73 is connected to a voltage source 74 (FIG. 10). From this voltage source, the electrical current is conducted via a line section 73a to the claw 58, in which the flange 56 rotatably engages. A sliding contact is made in the groove 57 of the claw 58 between the line section 73a and the flange 56.

OMPI posed; the corresponding grinding track 56a can be seen in FIG. 10. The current flows from the flange 56 via the pipe 55 to the slide 65 and its dovetail groove 64, in which the ball head 63 of the knife 61 slides. The ball head 63 is conductively connected to the conductor rail 72, which has the shape of a narrow spring steel rail. Their inclusion in the knife sheath 62 results in particular from FIG. 14, which shows a cross section through the sheath and knife.

The knife sheath, which is U-shaped throughout, has a leg 62a in which the current guide rail 72 is located. This leg 62a has an essentially unchanged cross-section over the entire length of the sheath 62, so that the conductor rail 72 is completely covered there and does not protrude outwards. As a result, no electrical contact can occur in the region of the sheath leg 62a with parts of body tissue along which the leg 62a moves.

Toward the other leg 62b of the sheath 62, the current guide rail 72 is provided with preferably integrally formed extension pieces 75, which are located at regular intervals on the current guide rail 72 (FIG. 13). These end pieces extend at right angles from the current conducting rail 72 and are also guided in a U-shape within the U-bend of the sheath 62 connecting the legs 62a, 62b and pass through the leg 62b in an embedded form up to its front edge, where they are freely conductive as contact 76 emerge. To improve the sliding properties of the sheath 62 in the tissue

-g3REΛ OMPI IPO the sheath leg 62b, which contains the extension pieces 75, can be designed in a crenellated manner according to FIGS. 12 and 13, so that fingers 77 result, in which the extension pieces 75 are accommodated and from the front edge of which the extension pieces 75 with a T -shaped widened contact head 78 emerge essentially flush. As a result, the effects of the electric current can be applied to the body tissue layer which comes into contact with the vaginal limb 62b.

The return of the current introduced into the patient's body via the contact heads 78 (FIG. 13) can be carried out monopolar in a conventional manner via a wide-area cathode, which in the

Drawing not shown and has been created at some suitable place on the patient's body. Alternatively, however, it is also possible to conduct the electrical current in a bipolar manner, ie. H. to return to the voltage source 74 within the conization device. For this purpose, the voltage is applied to the knife 61 as the second pole.

As can be seen from FIG. 10, the second pole is brought up via a line section 73b to a ring member 79, which is followed by an open contact rail 80 which is arranged on the upper edge of the control link 69 for the driving pin 68 . Provided that the driver pin 68 touches the contact rail 80 during its intended movements during conization, the current is passed on via this pin and the tube 50 carrying the pin to the stylus rod 48. which carries near its tip a driver pin 81 which engages in an opening of the knife 61 and thereby causes its oscillating movements. In this way, the second pole of the voltage source 74 is connected to the knife 61 and thus the bipolar system is produced. It is understood that the components connected to different poles must be insulated from one another.

The formation of the contact rail 80 and its arrangement in the control link 69 results in the effect that current is supplied to the contacts 76, 78 and to the knife 61 only when the knife arrives at the upper end of the slide 65 and into it Circular path is swung in, d. H. During the radial incision D (FIGS. 5 and 6), no electro-caustic takes place because the driver pin 68 does not touch the contact rail 80, so that no conductive connection is made and the circuit is not closed. There is no coagulation of the radial incision.

Due to the special design of the knife sheath 62 with its electrical contacts 76, 78, only the tissue remaining in the patient's body is caustically closed after the knife has been swung into the circular path, while the surface of the tissue of the conical sample remains unchanged, so that bleeding occurs on the one hand can be heavily contained, but on the other hand no impairment of the possibility of examining and assessing the removed tissue has to be accepted, as is the case with conventional electro-caustic the case is. The described configuration leaves behind a caustically sealed wound crater with a smooth, regular surface, to which the crenellated design of the leg 62b of the knife sheath 62 also contributes, since this enables a very uniform bending of the entire knife organ. Here, the conductor rail 72 also takes on the task of a stabilizing element in the U cutting of the knife 61, which contributes to the quiet knife guidance during the conical cutting path E, so that any vibration influences on the part of the knife drive are switched off.

This applies in particular to the case where the drive of the knife 61 is by an electromagnetic one

Vibrator (not shown) takes place, which allows the knife to oscillate at approximately 50 to 200 Hertz with a stroke of approximately 0.1 mm. A rubber cushion (not shown) can be used as an abutment for the knife holder. This drive has the advantage that the transmission shown in FIG. 1 can be partially omitted, which makes the device lighter in weight.

The features of the subject of the application disclosed in the patent claims, in the description and in the drawing can be essential for realizing the invention in its various embodiments, both individually and in any combination.

Claims

Patent claims

1. Device for the cone of the knife of the uterus, with a band-shaped flexible knife which is variable in position in the radial direction, characterized in that the knife (61) with its end to be inserted into the cervical canal at an axially back and forth movable rod (48) is seated and with its opposite end on a radially projecting from the axis of the rod (48), also axially back and forth slide (65) is radially pivoted and twisted about its longitudinal axis.

OM

2. Device according to claim 2, characterized gekenn¬ characterized in that the axially reciprocating stylus (48) telescopically by a likewise at the front end of the knife (61) engaging and rotatable pipe (50) is surrounded, which in turn is telescopically encased by an axially movable tube (55) which can be carried by it and which carries the radially projecting slide (65).

3. Apparatus according to claim 1 and 2, characterized ge indicates that on the slide (65) carrying the outer tube (55) from a diagonally to the axis of this tube (55) in the clockwise direction guide channel (70) rectangular cutout to the rear

(71) existing control link (69), in which a driver pin (68) protruding radially outward from the knife drive tube (50) engages in such a way that it rests on the outer end when the knife (61) is almost parallel to the knife drive tube (50) in the rest position of the guide channel (70) of the control link (69) is located (position A) and after switching on the stylus rod (48) and axially displacing the tube (55) carrying the slide (65) for the purpose of radially swiveling out the rear end of the knife after making a quarter turn of the knife drive tube (50) strikes the closest axially parallel edge of the link window (71) (position B) and after turning on the knife drive tube (50) for rotation clockwise after making a quarter turn on the opposite edge of the link window (71)

OMPI / .. IPO, < (Position C) and then the tube (55) carrying the slide (65) when the knife end is swung out.

4. Apparatus according to claim 1 to 3, characterized in that the drive for the Stichel¬ rod (48), for the knife drive tube (50) and for the slide (65) carrying tube (55) in a conventional manner in one pistol-shaped housing (9) is housed, the drive motor (2) being in the pistol grip (1).

5. Apparatus according to claim 1 to 4, characterized ge indicates that the motor shaft (7, 11) has a crankshaft (16) for transmitting reciprocating movement to the front of the housing (9) emerging rod (48) and via a reduction gear (22, 23) drives a worm drive (27, 29) which, via a shaft coupling (33) which can be switched off and a further reduction gear (35, 53), drives the knife drive tube (35) surrounding the stylus rod (48) 50) drives while the motor (2) be¬ active Sharing switch (37) trigger movement in the form of a Pistolen¬ simultaneously over a acting against a return spring (43) squat tooth ^■ rod drive (38-42) by means of pawl (57, 58 ) and flange (56) causes the axial movement of the tube (55) carrying the slide (65) for the rear end of the knife.

6. The device according to claim 1 to 5, characterized in that its from the drive housing

O (9) protruding parts can be removed by inserting the stylus rod (48), which can be detached from a resilient plug-in sleeve (47), and that can be plugged onto the pinion (35) of its drive shaft (34) with a bush (52, 53) toothed on the outer circumference

Knife drive tube (50) are led out through a removable union cap (44), while the claw (57, 58) engaging the flange (56) of the tube (55) carrying the slide (65) at the front end of the out of the housing (9) - Projecting rod (42) of the rack and pinion drive (38 - 42) is removably attached.

7. The device according to claim 1, characterized gekenn¬ characterized in that the ^' esser (61) at its rear end by means of a ball head (63) in one

Dovetail groove (64) is slidably and twistably guided on the end face of the slide (65).

8. The device according to claim 1, characterized in that the knife (61) with the exception of its cutting edge is encased by a sheath in the form of a flexible plastic sheath (62).

9. The device according to claim 8, characterized gekenn¬ characterized in that the sheathed knife (61) for length compensation compared to the plastic antel (62) when it bends at its rear end by means of a longitudinal groove (66) on a transverse pin (67) of the plastic jacket (62) is mounted so that it can move longitudinally.

OMPI

10. The device according to claim 8, characterized gekenn¬ characterized in that it is set up in a manner known per se for electro-caustics by introducing the electric current into the knife sheath (62), for which purpose a current guide rail (72) is embedded, which is connected to a voltage source (74) via an electrical line (73).

11. The device according to claim 10, characterized in that the current guide rail (72) is provided with conductive attachments (75) which extend to the outside of the sheath (62) and emerge exclusively there for contact, so that a Thermal coagulation only takes place at the cutting edge of the tissue that has not been removed.

12. The apparatus of claim 10 and 11, characterized in that the power supply to the knife sheath (62) is interrupted during the movement of the knife (61) to complete the straight radial incision (D).

13. The apparatus of claim 10 and 11, characterized in that the outside of the scabbard (62) towards the cutting edge of the knife (61) designed crenellated and with fingers (77) ver¬ see into which the conductive lugs ( 75) of the current guide rail (72) and from the tip area of which they emerge for contact with the tissue.

14. The apparatus according to claim 10 to 13, characterized in that the power supply to the

/.- WI Current guide rail (72) is provided in the knife sheath (62) via the slide (65) connected to the voltage source by means of sliding contacts.

15. The apparatus of claim 3, 12 and 14, da¬ characterized in that the one pole of the power supply via an in the control link (69) for the driver pin (68) arranged open contact rail (80) is guided so that the current only is then forwarded when the driver pin (68) comes into contact with the contact rail (80) during its movement, namely at the moment when the knife (61) swings into the conical circular path.

16. The apparatus of claim 10 and 11, characterized in that the current guide rail (72) with its conductive extension pieces (75) is integrally formed and U-shaped in cross section and consists of the flexible knife (61) stabilizing spring steel, the contact with the tissue emerging ends of the extension pieces (75) are in particular T-shaped widened.

17. The apparatus according to claim 10 and at least one of the subsequent claims, characterized in that the power supply to the

Current guide rail (72) is formed in the device with one pole by the second pole being guided over a body cathode.