WO2014172736A1

WO2014172736A1 - Apparatus for the preparation of anastomoses

Info

Publication number: WO2014172736A1
Application number: PCT/AT2014/050092
Authority: WO
Inventors: Dominik KOVÁCS; Thomas STEINLECHNER; Yuki TRIPPEL
Original assignee: Kovács Dominik; Steinlechner Thomas; Trippel Yuki
Priority date: 2013-04-22
Filing date: 2014-04-15
Publication date: 2014-10-30
Also published as: AT513482A4; AT513482B1

Abstract

Apparatus (1) for the preparation of anastomoses between en portions (2, 3) of hollow organs (4), in particular for the preparation of enteroanastomoses, comprising a device (7) for the connection of the end portions (2, 3), a cutting means (8) for the production of a through-opening between the connected end portions (2, 3), and an actuator (6) for actuating the connecting means (7) and the cutting means (8), as well as a control means (10), wherein the connecting means (7) and the cutting means (8) are disposed in a housing (5) capable of being moved along entirely within the hollow organ (4), in which housing (5) at least one electric drive motor (9) for actuating the connecting means (7) and the cutting means (8) is arranged, and wherein the control means (10) for controlling the at least one drive motor (9) is arranged in the actuator (6), which actuator (6) is connected to the housing (5) by an electric signal transmission means (11) only.

Description

Apparatus for the Preparation of Anastomoses

The invention relates to an apparatus for the preparation of anastomoses between end portions of hollow organs, in particular for the preparation of enteroanastomoses ,

comprising a device for the connection of the end portions, a cutting means for the production of a through-opening between the connected end portions, and comprising an actuator for actuating the connection means and the cutting means, as well as a control means.

Such apparatuses for the preparation of anastomoses are known from the prior art. Basically they serve the purpose of connecting end portions of hollow organs such as the

intestine, upon having severed the hollow organ by surgical operation e. g. for the purpose of removing a diseased

section. For this purpose, the apparatuses are inserted in the hollow organ to perform the connection from out of interior of the hollow organ and to further provide a continuous

connection between the hollow organ sections connected to each other .

From WO 2012/009431 A2 there is known a surgical

instrument for the connection of hollow organs, which, on the end of a shank insertable in a hollow organ, comprises a first portion comprising openings for braces and a second portion functioning as anchor and including pockets for partially accommodating the sides of the braces. A cutting element for the production of a through-opening is disposed inside the outer wall of the first portion. The functions of the surgical instrument are controlled via a handle. The depth of insertion in the hollow organ is limited by the length of the shank.

For the purpose of performing an anastomosis, the US

2005/0187576 Al discloses a surgical cutting and brace means on the end of a shank insertable in a hollow organ, which shank includes flexible shafts for transferring torques from motors arranged in an external drive unit to the cutting and brace means. Although the connection allows deeper insertion in the hollow organ via flexible shafts, the application, however, is essentially limited thereby in any portions of a hollow organ with narrow radii.

The US 5,337,732 A shows a robot for endoscopic procedures including a plurality of segments attached to each other and movable relative to each other, by which the robot, which is driven by balloons inflatable around the segments, may move in a snake-like fashion through a cavity or lumen in a patient's body. The robot comprises a video camera, light fixtures, a biopsy instrument and, where appropriate, other instruments such as laser or needles; however, it is not specifically designed for the preparation of anastomoses.

The US 2007/0156211 A relates to a lumen-travelling device comprising a drive system and including sensors for the

detection of different conditions in a cavity or lumen. As a result of specific conditions detected, a plurality of measures such as, among other things, surgical steps may be performed. The device may include a cutting tool. As a matter of fact, the device may penetrate deep into the hollow organs by means of the drive system; however, it is not designed for the preparation of anastomoses .

A radio capsule for the examination of the entire

gastrointestinal tract may be gathered from the article

"Swallowable Wireless Capsule Endoscopy: Progress and Technical Challenges", Hindawy Publishing Corporation, Gastroenterology Research and Practice, Volume 2012 (2012), Article ID 841691, doi : 10.1155/2012/841691

(http://www.hindawi.com/ ournals/grp/2012/841691) . The capsule has a diameter of 11 mm and e. g. a length of 26 mm and is swallowed by the patient. On its way through the

gastrointestinal tract, the capsule takes pictures, which are transmitted wirelessly to a receiver. The capsule may include sensors and a mechanical arm for e. g. micro-surgeries; however, it is not suited for the preparation of anastomoses, since it is transported through the gastrointestinal tract in a natural way.

Thus, such known apparatus have the disadvantage of being suitable only for the preparation of anastomoses in specific regions lying close to the entry opening, or of being capable of reaching into any regions of a hollow organ, however, of being not adapted for the preparation of anastomoses of hollow organs.

The invention has the object of providing an apparatus for the preparation of anastomoses between end portions of hollow organs, in particular the preparation of enteroanastomoses , which avoids or reduces the disadvantages known from the prior art. Concerning the preparation of anastomoses in essentially any regions of hollow organs, the apparatus is meant to allow an application as safe and simple as possible, meaning as little stress as possible for the patients.

This object is solved by the above mentioned apparatus, whereby the connecting means and the cutting means are disposed in a housing capable of being moved along entirely within the hollow organ, in which housing at least one electric drive motor for actuating the connecting means and the cutting means is arranged, and the control means for controlling the at least one drive motor is arranged in the actuator, which actuator is connected to the housing by an electric signal transmission means only. The housing is small enough to be able to be moved essentially along and through the entire hollow organ, in particular the intestine of a patient, starting from an entry opening. In particular, the housing may be moved also through strongly curved sections, since it is not connected to rigid or insufficiently flexible elements, such as a shank or flexible shafts. All structures which are suited for the preparation of anastomoses and accordingly may be adapted miniaturized for the placement within the housing are possible as connecting means and cutting means. The connecting means serves the purpose of connecting the end portions by connecting their tissue to each other e. g. either directly or by means of disposing termination elements inbetween. Any possible termination elements are permanently connected to the respective end portions and serve the purpose of closing the end portions during surgery. By means of the cutting means, a through-opening is machined in the produced connection of the end portions, to again provide a continuous hollow organ. The connecting means and the cutting means are actuated by at least one electric drive motor, whose motion is converted into corresponding movements of the

connecting means and the cutting means. The drive motor may have a rotating output shaft or be a linear motor and it is

controlled via a control means disposed in the actuator. The actuator is arranged in a spatially separated fashion from the housing and thus allows remote control of the drive motor and hence the connecting means and the cutting means by the surgeon via an electric signal transmission means only. When the signal transmission means is formed by at least one electric line, the at least one electric drive motor may be supplied with electric power via said line(s) . The at least one line is formed in a manner surrounded by an insulation layer and as flexible as possible, so as to not impair the movement of the housing within the hollow organ. The electric line is preferably connected to the housing or the drive motor in a stable manner, such that the housing can be pulled out of the hollow organ via the line, upon having performed the connecting and cutting steps. Thus, further cuts in the hollow organ may be avoided for the removal of the apparatus.

When the signal transmission means is designed for a

wireless signal transmission, the housing is mechanically decoupled completely from the actuator. The drive motor is power-supplied by batteries and accumulators, the control instructions for the performance of the movements of the drive motor being wirelessly transmitted via transmitting and

receiving modules in the housing and the actuator. Transmission takes place preferably by means of known transmission processes, which are essentially immune to any interferences, such as is known, for example, from UMTS or LTE transmissions.

The connecting means is preferably formed by a circular stapler arranged in the housing and a pressure plate. Surgical braces are accommodated in the circular stapler essentially along a circular path; for the production of the connection, they are driven by the at least one drive motor and pressed against the pressure plate. The pressure plate has notches opposite the braces, in which the sides of the braces are bent. Thus, the connection of the end portions of the hollow organ is produced by means of surgical braces. For this purpose, the pressure plate is moved against the circular stapler by the drive motor, so that the tissue sections to be connected or any possible termination elements of the end portions are clamped in a fixed position between the circular stapler and the pressure plate. Thus, a particularly stable, essentially circular brace connection of the end portions is produced close to their peripheral wall.

According to a preferred embodiment of the present

invention, two drive motors are disposed in the housing, the first drive motor being designed to move the pressure plate with respect to the circular stapler and the second drive motor for the actuation of the circular stapler and the cutting means. By providing two drive motors, clamping the end portions by the pressure plate in a suitable position relative to each other may be performed at a different time than the production of the connection, in particular a brace connection, and the cutting of a through-opening. Thus, it is possible to place the braces as soon as the surgeon has finished clamping of the end portions and is ready to perform further surgical steps. Both drive motors may preferably be remote-controlled by the actuator independently of each other. Driving the pressure plate and the circular stapler and the cutting means may also be simplified by means of two drive motors, since in the case of a single drive motor, the correct timing of connecting, clamping and cutting would have to be ensured by a corresponding mechanical

construction. Furthermore, the drive motors may be dimensioned for different rotational speeds or be driven thereby. Thus, the cited steps may be performed at a correspondingly appropriate speed .

To be able to produce the connection of the end portions of the hollow organs in a particularly simple fashion, the pressure plate is detachably connected to the first drive motor via a retaining mandrel. The retaining mandrel is temporarily fixed to the pressure plate and pulled toward the housing by the drive motor for the production of the clamp joint of the end portions. Driving the pressure plate is effected in a particularly simple manner, when the retaining mandrel is connected to the drive motor via a spindle. Thus, the motion, in particularly a rotary motion of the drive motor, is transferred into a longitudinal motion of the pressure plate in axial direction of the

apparatus. The pressure plate is preferably fixed in a reliable and detachable fashion in a position opposite the circular stapler by means of a click-on connection and may be designed accordingly for the purpose of penetrating tissue or any

possible termination element of the end portion. At the end of the surgical procedure, the clamp joint between the circular stapler and the pressure plate may be loosened and the pressure plate may be taken out of the hollow organ. Control of the connecting means and the cutting means may be effected in a particularly advantageous fashion, if the housing accommodates means connected to the control means and meant to detect the position of the retaining mandrel. By detecting the position of the retaining mandrel in the housing and imparting it to the control means, the latter may prevent incorrect operation of the apparatus. For example, establishing the connection of the end portions of the hollow organ may be prevented, unless these are adjacent. The means for detecting the position of the retaining mandrel may be designed such that they give feedback of the end positions of the retaining mandrel or, alternatively, of several defined positions of the retaining mandrel. Any other position of the retaining mandrel may

likewise be fed back. For example, the drive motor driving the retaining mandrel may be a servomotor designed for giving feedback of the position. Feedback to the control means takes place via the signal transmission means. When the control means knows the current position of the retaining mandrel, it may additionally adapt the speed of the at least one drive motor as a function of the position to slow down, for example, the process of pulling the pressure plate as the distance to the circular stapler decreases.

If the at least one drive motor is formed by a gear motor, the rotational speed and torque of its drive shaft may be adapted to the given requirements for driving the connecting means and the cutting means. In particular, providing a gear motor comprising a reduction gearing may allow the drive shaft of the motor to be driven at a higher torque and lower speed.

According to another preferred embodiment of the present invention, the actuator comprises actuating elements for the activation of the at least one drive motor and at least one display connected to the control means. The purpose of the display is to inform the user of the actuator of the current status of the surgical procedure or the control, so that he may carry out the necessary correct control measures. The actuator advantageously includes the display of a power supply, of the functional connection of the actuator to the housing by the signal transmission means as well as indications of any control measures which can be performed next. LCD displays or light emitting diodes are particularly suited as displays.

Alternatively or additionally, acoustic or mechanical e.g.

vibrating display means may be provided. To perform the control measures, the actuator comprises actuating elements which are designed e. g. as push-buttons or switches. In accordance with the control instructions from the user, the at least one drive motor will be activated or deactivated, respectively by the control means.

For an application, in particular positioning of the apparatus as precise and safe as possible, the actuator and/or the housing comprise an interface for the connection to a surgical robot. The actuator or the connection means and the cutting means in the housing may thus be also actuated by the surgical robot. The interface may be designed for wireless or wired connection and serves to transmit control instructions or status feedback. Thus, the actuator may also comprise means for displaying the states of the surgical robot, which are essential to carrying out the surgery. For reliable positioning the apparatus it is advantageous when the housing, a e. g.

cylinder-shaped housing, has essentially plane surface areas, which facilitate a stable support of the housing.

The invention will be explained more fully below on the basis of preferred, non-limiting embodiments with reference to the drawings .

Fig. 1 shows a block diagram of an anastomosis apparatus according to the invention;

Fig. 2 shows a perspective view of the housing of the apparatus, which housing can be inserted in the hollow organ;

Fig. 3 shows, in an exploded view, the housing according to Fig. 2; and

Fig. 4 shows the housing placed in a hollow organ and intended to perform an anastomosis.

Fig. 1 shows the apparatus 1 for the preparation of

anastomoses between end portions 2, 3 of hollow organs 4 (cf. Fig. 4) comprising a housing 5 capable of being moved along entirely within the hollow organ 4 and comprising an actuator 6. The housing 5 comprises a device 7 for the connection of end portions 2, 3 and a cutting means 8 for the production of a through-opening between the connected end portions 2, 3 of the hollow organ 4, which are driven by at least one electric drive motor 9. The actuator 6 serves to actuate the connecting means 7 and the cutting means 8 and, for this purpose, comprises a control means 10, by means of which the at least one drive motor 9 is controlled. The drive motor 9 is connected to the

connection means 7 and the cutting means 8 such that its rotary motion is transferred to the corresponding required movements of the connecting means 7 and cutting means 8. Advantageously, however, two electrical drive motors 9' , 9' ' are provided that drive different functional units of the apparatus. Most

importantly, the housing 5 is connected to the actuator 6 by an electric signal transmission means 11 only. Said signal

transmission means 11 may be formed by means of at least one insulated electric line or wireless signal transmission. In the latter case, the housing 5 and the actuator 6 comprise

appropriately designed transmitters and receivers known to the person skilled in the art, which will not be discussed any further herein.

As is clearly shown in Fig. 2 in particular, the housing 5 has an essentially cylindrical shape, favouring the movement of the housing 5 along the hollow organ 4. For this purpose, the housing 5 is designed in an appropriately small size. In

particular, its length may be e . g. 80 mm and its diameter 35 mm. In addition, the housing 5 has essentially plane surface areas 12 to facilitate gripping and holding of the housing 5 for the purpose of moving on within the hollow organ 4.

A circular stapler 13 comprising openings 14 for the output of surgical braces (not shown) is mounted on the right-hand end of the housing 5 shown in Fig. 2. A pressure plate 15 is

disposed opposite of the circular stapler 13, which, just like the circular stapler 13, is part of the connecting means 7 and may be fixed in a detachable manner to a retaining mandrel 16 in the housing 5. For this purpose, the pressure plate 15 includes a collet 17 adapted for the detachable connection to the

retaining mandrel 16. For the approach of the pressure plate 15 toward the circular stapler 13 for the production of the

connection of the end portions 2, 3 of the hollow organ 4, the retaining mandrel 16 is adapted to be shifted in axial direction of the housing 5, driven by the first drive motor 9' . For the production of the brace joint, the pressure plate 15 comprises notches (not shown) located opposite the openings 14 of the circular stapler 13, in which notches the sides of the braces are bent. The openings 14 are shown in a manner disposed on a circular trajectory, however, a deviating positioning is also possible .

Fig. 3 shows, in an exploded view, the part of the apparatus 1 which can be inserted in the hollow organ 4 and may be moved along therein. The drive motors 9', 9'' are arranged in a stationary fashion in a motor housing 18, attached to which is a guide element 19 for guiding spindles 20, 21. The spindles 20, 21 serve the conversion of the rotary movements of the drive motors 9' , 9' ' to a longitudinal motion in axial direction of the housing 5. In particular, in the shown embodiment, the spindle 20 is driven by the first drive motor 9' and is

connected to the retaining mandrel 16 for the longitudinal displacement of the pressure plate 15. The spindle 21, however, is driven by the second drive motor 9' ' , such as to displace in longitudinal direction of the housing 5 a cylindrical element 22 which is provided for the delivering of the surgical braces and the actuation of the cutting means 8. The cylinder element 22 thereby moves a clamp head 23, and via the latter it moves laminas 24 toward a front plate 25 being stationary relative to the housing 5, which includes the surgical braces and the openings 14 for the output of the braces. These braces are pressed out of the openings 14 and against the pressure plate 15 by the pressure of the laminas 24 on the surgical braces.

Furthermore, the clamp head 23 moves a knife 26 in longitudinal direction of the housing 5 against the pressure plate 15, to produce the through-opening between the connected end portions 2, 3.

For the production of anastomoses between the end portions 2, 3 of hollow organs 4, the actuator 6, as is shown in Fig. 1, comprises actuating elements 27 for the activation of the drive motors 9' , 9' ' and at least one display 28 connected to the control means 10. The drive motors 9', 9'' are connected to the control means 10 via the signal transmission means 11 and are activated or deactivated by the control means 10, as a function of the actuation of the actuating elements 27. Feedback of the respective positions of the pressure plate 15 or the connecting means 7 and the cutting means 8 to the user of the actuator 6 is particularly advantageous for fault-free actuation of the actuating elements 27. For this purpose, the housing 5 includes means 29 for the detection of the position of the retaining mandrel 16. The position ascertained is transmitted to the display 28 connected to the control means 10 via the signal transmission means 11.

For example, it may be indicated by the display that the retaining mandrel 16 can be extended from the housing 5 in longitudinal direction. By actuating a first actuating element 27', the control means 10 can be instructed to activate the drive motor 9' . The pressure plate 15 can thus be connected to the extended retaining mandrel 16, the tissue of the end

portions 2, 3 or a termination element closing the end portions 2, 3 being positioned between the circular stapler 13 and the pressure plate 15. Thereupon, the display can indicate that the retaining mandrel 16 can be retracted again in the housing 5. Actuation of a second actuating element 27'' can instruct the control means 10 to activate the drive motor 9' to rotate in opposite direction, whereby the tissue parts of the end portions 2, 3 are pressed against each other between the circular stapler 13 and the pressure plate 15. It is indicated to the user of the apparatus 1 when the retaining mandrel 16 has reached its end position in the housing 5. Actuation of a third actuating element 27''' can instruct the control means 10 to activate the drive motor 9' ' . Thereby, the clamp head 23 presses both the surgical braces from the front plate 25 as well as the knife 26 into the tissue parts or termination elements to be connected. Subsequently, the control means 10 activates the drive motor 9' ' to rotate in opposite direction, to again retract the clamp head 23, and the drive motor 9' to again extend the retaining mandrel 16, so that the pressure plate 15 can be taken off the retaining mandrel 16.

Fig. 4 shows a housing 5 inserted in a hollow organ 4, in particular an intestine. The end portions 2, 3 are temporarily closed with the termination elements 34, 35, a pressure plate 15 being already connected with its collet 17 to the termination element 35. The connecting means 7 and the cutting means 8 positioned in the housing 5 are actuated by means of the

actuator 6.

Furthermore, it may be gathered from Fig. 1 that the actuator 6 can include an interface 30 and the housing 5 an interface 31 for the connection to a surgical robot 32

comprising a corresponding interface 33. In this manner, the surgery can be performed in a manner aided by the surgical robot 32. The interfaces 31, 32, 33 serve the transmission of control instructions or the feedback of parameters which are essential to the control of the surgery, such as positional information.

Claims

1. An apparatus (1) for the preparation of anastomoses between end portions (2, 3) of hollow organs (4), in particular for the preparation of enteroanastomoses , comprising a device

(7) for the connection of the end portions (2, 3), a cutting means (8) for the production of a through-opening between the connected end portions (2, 3), and an actuator

(6) for actuating the connecting means (7) and the cutting means (8), as well as a control means (10), characterized in that the connecting means (7) and the cutting means (8) are disposed in a housing (5) capable of being moved along entirely within the hollow organ (4), in which housing (5) at least one electric drive motor (9) for actuating the connecting means (7) and the cutting means (8) is arranged, and that the control means (10) for controlling the at least one drive motor (9) is arranged in the actuator (6), which actuator (6) is connected to the housing (5) by an electric signal transmission means (11) only.

2. The apparatus (1) according to claim 1, characterized in that the signal transmission means (11) is formed by at least one electric line.

3. The apparatus (1) according to claim 1, characterized in that the signal transmission means (11) is designed for wireless signal transmission.

4. The apparatus (1) according to any of claims 1 to 3,

characterized in that the connecting means (7) is formed by a circular stapler (13) disposed in the housing (5) and a pressure plate (15) .

5. The apparatus (1) according to claim 4, characterized in that two drive motors (9', 9'') are arranged in the housing (5), the first drive motor (9') being designed for moving the pressure plate (15) with respect to the circular stapler (13) and the second drive motor (9'') for actuating the circular stapler (13) and the cutting means (8) .

6. The apparatus (1) according to claim 5, characterized in that the pressure plate (15) is detachably connected to the first drive motor (9') via a retaining mandrel (16) .

7. The apparatus (1) according to claim 6, characterized in that the housing (5) accommodates means (29) connected to the control means (10) and meant to detect the position of the retaining mandrel (16) .

8. The apparatus (1) according to any of claims 1 to 7,

characterized in that the at least one drive motor (9) is formed by a gear motor.

9. The apparatus (1) according to any of claims 1 to 8,

characterized in that the actuator (6) comprises actuator elements (27, 27', 27'', 27''') for activating the at least one drive motor (9) and at least one display (28) connected to the control means (10) .

10. The apparatus (1) according to any of claims 1 to 9,

characterized in that the actuator (6) and/or the housing (5) comprises an interface (30, 31) to connect to a

surgical robot (32) .