The invention relates to a medical instrument, in particular a tubular shaft instrument, for cutting tissue.
In modern medicine, attempts are generally made to keep the damage to intact tissue to a minimum. Thus, when circumstances permit, minimally invasive surgery is usually the preferred method used to perform an operative intervention. Small incisions and little trauma to the tissue lead to a lower sensation of pain after the operation and to rapid recovery and mobilization of the patient. This also applies to laparoscopic surgery during which complex operations are performed in the abdominal cavity.
Operations of this type and the instruments required for them present a particular challenge to the manufacturers of medical instruments as the majority of the operative steps are performed in very restricted spaces and without direct visual contact. Thus the medical instruments used must not only be able to operate in the smallest spaces but must also function so reliably that visual monitoring is superfluous. The instruments are preferably constructed such that even without visual contact the operating surgeon always has feedback which enables him to draw conclusions about the progress of the operation.
This applies particularly to all instruments that are suitable for the separation of tissue. As scalpels having an open blade are, if anything, unsuitable for minimally invasive surgery (cf. DE 44 44 166 A1), scissors-type or tong-type instruments with mouth parts are frequently resorted to, which cover the blade during insertion of the instrument on one hand and simultaneously take on a holding function for the tissue to be cut on the other. The blade is then displaced back and forth inside the mouth parts for cutting.
In the tong-like instruments, the blade or scalpel is usually covered completely by the associated mouth parts. It is, therefore, all the more difficult to draw conclusions as to whether the gripped tissue has already been completely separated with one or a plurality of cutting movements. This knowledge, however, is crucial for the positive progress of the operation.
On the other hand, excessively moving the blade when the tissue is already separated can quickly lead to wear on the instrument. Thus it is essential always to check the instruments for their cutting ability and to replace worn blades. This form of maintenance is not only expensive but also time-consuming. Often it is not possible to replace individual elements of the instruments which is the reason why the whole instrument has to be replaced.
Proceeding from this prior art, the object of the present invention is to provide a medical instrument, which guarantees reliable separation of tissue and provides a long-lasting functionality.
This object is achieved by a medical instrument according to the present claim 1.
In particular, the object is achieved by a medical instrument having a first and a second mouth part each with at least one clamping surface for fixing and/or positioning tissue in a fixing plane, a cutting device with a blade, which is disposed opposite one of the mouth parts for cutting tissue and is displaceable over a predetermined cutting path substantially parallel to the fixing plane, a first electrode and a second electrode, which are disposed on the cutting device and/or the clamping surface in such a manner that a mechanical contact between cutting and clamping surface is ascertainable by means of a processing unit connected to the electrodes.
An essential idea of the invention is thus to ascertain by means of electrodes, a mechanical contact between a blade and an associated clamping surface in a medical instrument for separating tissue. The mechanical contact may be ascertained electrically or by means of a switch. The processing unit receives the corresponding signals and evaluates them.
In a preferred embodiment, the blade comprises the first electrode, the clamping surface comprises the second electrode and the processing unit comprises a device for determining an electrical resistance between the electrodes. The first electrode is thus formed by an electrically conductive blade or an electrically conductive section of the blade. The second electrode is the electrically conductive clamping surface or an electrically conductive section of the clamping surface. The processing unit measures the electrical resistance between the first and the second electrode. Preferably, the processing unit then ascertains that the tissue located immediately under the blade is separated when the resistance is lower that a preset threshold limit. This is necessary as the tissue to be cut has a certain electrical conductivity and consequently a high-ohm contact already exists between the first electrode and the second electrode when the tissue is unseparated. By specifying a threshold value, it is possible to differentiate the contact closure by way of the tissue to be cut from a direct contact closure between the two electrodes. This direct contact closure is an indicator for mechanical contact between blade and clamping surface.
Preferably, the processing unit is designed in such a manner that a curve of the resistance is ascertainable during the cutting path. The cutting path defines an observation interval for the processing unit and may, for example, include a back and forth movement of the blade between a distal and a proximal section of the mouth parts.
It is possible to detect the movement of the blade manually. Thus a mechanical limit stop during movement of the blade by means of an actuating device can provide information about the distance covered or about the cutting path covered. Preferably, the processing unit comprises a travel sensor and/or electric switch for detecting the displacement of the blade parallel to the clamping surface. The said cutting device is designed in such a manner that it may be moved back and forth along a longitudinal axis of the medical instrument parallel to the clamping surface. The blade, therefore, should preferably separate the tissue not only at one point but over a cutting area along said longitudinal displacement. To effectively determine whether the tissue is completely separated in this region, it is advantageous to record the blade's movement over an observation interval or an observation path and to determine whether there is a continuous mechanical contact between blade and clamping surface. The movement of the blade may be ascertained either directly by means of a travel sensor, or it may be ascertained indirectly by means of switches at the end of the cutting range whether the blade has been moved from a first switch to a second switch. Here too, the tissue is only deemed to have been completely separated when there is a mechanical or electrical, in particular a low-ohm, contact between blade and clamping surface within the entire interval or during the entire cutting path, that is to say from a movement of the blade from the first switch to the second switch.
Preferably, the two mouth parts each comprise a coagulation electrode for coagulation of the fixed tissue. Consequently, the tissue can be coagulated by means of a high-frequency current prior to mechanical separation by means of the blade. A safe closure of the vessels is ensured prior to mechanical separation. Furthermore, one of the two coagulation electrodes may be linked to the processing unit and thus be used to determine the mechanical contact. For formation of the coagulation electrodes, the mouth parts are either at least partially electrically conductive or they have an electrically conductive coating on the side facing towards the tissue.
Preferably, the at least one mouth part comprises a blade guide. The blade guide is used to stabilise the blade during the cutting movement. Furthermore, the blade guide may have said switches or travel sensors in order to determine the blade's movements.
Preferably, the medical instrument has means for emitting a signal, which is then emitted when the resistance drops below a predetermined minimum value over the entire cutting path. This form of display may thus be used not only to determine the resistance and hence the progress at a point or at a position of the blade when separating tissue, but also to determine a complete separation of the tissue over the entire cutting path.
Further advantageous embodiments emerge from the other subclaims.
The invention will be described in the following based on embodiments which will be explained in greater detail by means of drawings. The drawings show:
The same reference numerals are used in the following description for identical parts and parts acting in an identical manner.
The particular advantages of such a relocated fulcrum 1 are shown on the basis of the schematic diagrams of
Whilst in
Seen from the side (cf.
Compared to articulations that only have a single-point connection, the guide mechanisms or articulation 40 additionally have the advantage of high stability. Due to the convex and concave sections which engage with each other, a large-area contact region is formed and articulation 40 can absorb significantly more force than an articulation with a single-point connection. To further stabilise articulation 40, first mouth part 10 comprises a first articulation guide bearing 46 and a second articulation guide bearing 46′. Like articulation guide pins 42, 42′, articulation bearings 46, 46′ are attached alternately on the inside of the sidewalls of first mouth part 10.
First articulation guide bearing 46 and first guide pin 42 are spaced apart such that they accommodate first articulation guide rail 41 in the space between them. First articulation guide bearing 46 has a concave cross-section, which engages with convex section 44 of first articulation guide rail 41. On opening and closing tool head 30, first articulation guide rail 41, guided by first guide pin 42 and first articulation guide bearing 46, rotates about fulcrum 1.
Likewise, second articulation guide rail 41′, guided by second guide pin 42′ and articulation guide bearing 46′, rotates about fulcrum 1. For this, second articulation guide rail 41′, second articulation guide pin 42′, a convex section 44′ of second articulation guide rail 41′ and second articulation guide bearing 46′ are designed and disposed symmetrically to first articulation guide rail 41, first articulation guide pin 42, convex section 44 of first articulation guide rail 41 and first articulation guide bearing 46.
As shown in
By attaching a first end of tension strip 27 to convex sections 44, 44′ of articulation guide rails 41, 41′, it is ensured that the tensile force exerted by means of tension strip 27 always acts substantially tangentially to the circular motion of curved articulation guide rails 41, 41′ about fulcrum 1. Thus a uniform transmission of force independent of the opening angle is assured. A second end of tension strip 27 is operatively connected to handle 110 and may be displaced by means of a control device provided thereon. Due to virtual fulcrum 1, which, as already explained, is located outside and above mouth parts 10, 10′, the distance between fulcrum 1 and the first end of tension strip 27 is significantly greater than the distance achieved with normal articulations. Thus the embodiment of the tubular shaft instrument described has a significantly higher leverage by means of which second mouth part 10′ may be moved over tension strip 27.
Both mouth parts 10, 10′ each have a clamping surface 12, 12′ for fixing the tissue. First mouth part 10 thus has, on a distal section, a first clamping surface 12 which faces upwards. First clamping surface 12 is formed substantially concave transverse to the longitudinal axis of first mouth part 10. In the closed state of tool head 30, convex second clamping surface 12′ of second mouth part 10′ lies substantially parallel to this first clamping surface 12.
In the embodiment described, these clamping surfaces 12, 12′ are not only suitable for securely fixing the tissue to be cut later, they also form the electrodes for a coagulation process. To achieve this, sections of clamping surfaces 12, 12′ are electrically conductive and connected via printed conductors to a high-frequency current source, which is also controllable by way of handle 110. Thus the tissue gripped may be cauterised to such an extent prior to the cutting procedure that separation is possible without bleeding. Preferably, sections at least of mouth parts 10, 10′ are manufactured from ceramic material by the injection moulding method. Thus the guide elements, in particular articulation guide rails 41, 41′ and articulation guide pins 42, 42′ of articulation 40, are easy to form. Articulation 40 of ceramic material forms an electrical insulation between mouth parts 10, 10′, in particular between their electrodes for coagulation.
In the present embodiment, the actual mechanical cutting process takes place after coagulation. To achieve this, a cutting device 50 is moved parallel to a fixing plane x-y (cf.
Prior to the cutting process, blade 51 is drawn back so far towards tubular shaft 24 that premature injury of the tissue is not possible. Preferably, the blade in first mouth part 10 is at the level of articulation guide pins 42, 42′. From this starting position, blade 51 is brought onto fixing plane x-y by way of a ramp 55 integrated in second mouth part 10′ (cf.
After closing mouth parts 10, 10′, blade 51 thus glides out of its starting position over ramp 55 into said channel and may there be pulled or pushed distally and proximally over the tissue. Blade 51 is preloaded in relation to fixing plane x-y in order to ensure that this displacement separates the tissue step by step. A preloading device exerts a force perpendicular to fixing plane x-y, which presses blade 51 against the plane. This force is built up via the resilience of guide wire 52 and its curvature. As can be seen from
The most varied embodiments are conceivable in respect of the design of blade 51. These will be described in the following on the basis of
Preferably, blade 51 is microtoothed overall.
In an alternative embodiment (cf.
The advantageous cutting device 50 of the invention has been described so far in conjunction with the advantageous articulation shape. Both inventions, however, may also be executed separately from one another.
Thus,
In one embodiment according to the invention, the tubular shaft instrument further comprises a cut monitoring device. This determines when the tissue between the two clamping surfaces 12, 12′ is completely separated. In the embodiment, blade 51 rests on first clamping surface 12 when the tissue is completely separated. As clamping surface 12 comprises an electrode for coagulation, it is electrically conductive in parts at least. According to the invention, at least one section of blade 51, which mechanically contacts separating surface 12 when the tissue is separated, is likewise formed of electrically conductive material. The electrical contact between blade 51 and clamping surface 12 is determined by means of a cut monitoring device. The gripped tissue is deemed to be completely separated when a continuous electrical contact exists between blade 51 and clamping surface 12 during a complete cutting movement by tip 16′ of second mouth part 10′ up to ramp 55. As can be seen from
Alternatively, it may also be constantly indicated to the user whether there is a direct mechanical contact between blade 51 and clamping surface 12. As the user performs the movement of blade 51 manually, he can draw conclusions independently as to whether the tissue is adequately separated.
In a further embodiment, travel sensor 102 comprises two electrical contact regions on the distal and proximal end of blade guide 53, which are designed in such a manner that it is possible to determine contacting between blade 51 and the distal contact region as well as between blade 51 and the proximal contact region. Processing unit 100 can thus determine the start and end of the observation interval.
Moreover, handle 110 has a finger trigger 130, which is likewise rotatably attached to handle body 117. Cutting device 50, in particular blade 51, may be displaced distally by operating finger trigger 130. A spring element (not illustrated) inside handle body 117 returns finger trigger 130 to its starting position after operation, as a result of which cutting device 50 is displaced proximally. Finger trigger 130 is disposed distally in front of first handle lever 122 in such a manner that finger trigger 130 can be operated with the first finger on grasping handle levers 122, 122′.
Handle 110 has a momentary contact switch 116 on the proximal side of handle body 117, which controls the coagulation current. In an alternative embodiment, it is possible in place of momentary contact switch 116 to provide a control device having a plurality of actuating elements by means of which a plurality of coagulation modes may be selected and performed. It is likewise conceivable to provide display device 101 on handle body 117.
In one embodiment according to the invention, tubular shaft 24 and handle 110 are designed in such a manner that tubular shaft 24 may be detachably inserted into handle 110. To achieve this, a receiving opening 112, which can be closed by means of a cover, is located on the side of handle 110.
Thus, prior to the operation, a sterile disposable tubular shaft 24 having appropriate tool head 30 and cutting device 50 is inserted into reusable handle 110 and locked therein. Reuse of tubular shaft 24 and the associated devices is not envisaged. Handle body 117 has a first coupling element 114 or a coupling element, a second coupling element 114′ or a coupling element and a third coupling element 114″ or a coupling element for mechanical connection of tool head 30, cutting device 51 and tubular shaft 24. A ring provided on the proximal end of tubular shaft 24 engages with third coupling element 114″ in such a manner that the tubular shaft is rigidly connected to handle body 117. A first inner tube adapter 22 engages, by means of a ring likewise disposed on the proximal end, with first coupling element 114, which is in operative connection with second handle lever 122′. The displacement of second handle lever 122′ is transferred to first coupling element 114 by means of a mechanism disposed inside handle body 117 and transfers this displacement in turn to first inner tube adapter 22. This is directly or indirectly joined mechanically to second mouth part 10′ by way of tension strip 27. A longitudinal displacement of first inner tube adapter 22 in relation to tubular shaft 24 thus brings about opening and closing of mouth parts 10, 10′.
A second inner tube adapter 22′ is disposed movably in relation to first inner tube adapter 22 inside said first inner tube. This inner tube adapter 22′ is operatively connected to guide wire 52 and displaces blade 51. Inserting tubular shaft 24 into handle body 117 engages a proximal ring on the end of second inner tube adapter 22′ with second coupling element 114′ and transfers the displacement or the force exerted by means of finger trigger 130 to cutting device 50.
In order to make it easier to insert disposable tubular shaft 24, a removable fastening is provided thereon, which holds inner tube adapter 22, 22′ in a predetermined position relative to tubular shaft 24, which is designed in such a manner that the rings are easily insertable into coupling elements 114, 114′, 114″.
Coupling elements 114, 114′, 114″ are designed in such a manner that tubular shaft 24 may be rotated in relation to handle 110. Thus the alignment of tool head 30 can be adjusted freely in relation to handle 110. During rotation, the rings of inner tube adapters 22, 22′ and of tubular shaft 24 rotate in coupling elements 114, 114′, 114″ and thus form an articulation.
Number | Date | Country | Kind |
---|---|---|---|
10 2006 046 919.4 | Oct 2006 | DE | national |
10 2006 046 920.8 | Oct 2006 | DE | national |
10 2006 047 204.7 | Oct 2006 | DE | national |
10 2006 047 215.2 | Oct 2006 | DE | national |
10 2006 059 175.5 | Nov 2006 | DE | national |
Filing Document | Filing Date | Country | Kind | 371c Date |
---|---|---|---|---|
PCT/EP07/08388 | 9/26/2007 | WO | 00 | 4/3/2009 |