Source: https://patents.google.com/patent/EP2473119B1/en
Timestamp: 2019-09-21 17:58:08
Document Index: 598083699

Matched Legal Cases: ['art 2', 'art 2', 'art 2', 'art 2', 'art 15', 'art 15', 'art 2', 'art 15', 'art 15', 'art 2', 'art 2', 'art 2', 'art 2', 'art 2', 'art 2', 'art 2', 'art 2', 'art 6', 'art 2', 'art 2', 'art 2', 'art 2']

EP2473119B1 - Surgical device and accessories - Google Patents
EP2473119B1
EP2473119B1 EP10773698.5A EP10773698A EP2473119B1 EP 2473119 B1 EP2473119 B1 EP 2473119B1 EP 10773698 A EP10773698 A EP 10773698A EP 2473119 B1 EP2473119 B1 EP 2473119B1
EP10773698.5A
EP2473119A2 (en
Csiky Laszlo
Csiky, László
2010-09-02 Application filed by Csiky, László filed Critical Csiky, László
2012-07-11 Publication of EP2473119A2 publication Critical patent/EP2473119A2/en
2015-04-01 Publication of EP2473119B1 publication Critical patent/EP2473119B1/en
The present invention is a surgical device system developed for the new types of surgical procedures, which is - advantageously similarly to the laparoscopic technique - able to accomplish all steps (access, surgical intervention, closure) of NOTES (Natural Orifice Transluminal Endoscopic Surgery), SPLS (Single Port Laparoscopic Surgery) and IE (Interventional Endoscopy) procedures, and said device system - according to an advantageous embodiment - comprises laparo-endoscopic instruments, trocar sleeves, a tube or an endoscopic device, and further attachable accessories.
Another innovative idea is described in the WO/2008/131046 patent application. This instrument is a simple modification of the traditional laparoscopic instruments: both the head and the handle of the instrument are bendable simultaneously toward each other. The bending of the handle controls the synchronous bending of the head by wires. In fact, this instrument was developed primarily for the SPLS (Single Port Laparoscopic Surgery), where usually the navel is used to enter the abdominal cavity. This new SPLS method is considered to be an alternative to the NOTES technique. Actually the SPLS is a variation of laparoscopy. A major drawback of this solution is that the movements of the inner and outer ends of the cited instrument are contrariwise as compared to the conventional laparoscopic instrument, and this is really difficult to learn. The relative congestion of the instruments in the above mentioned ideas is another disadvantage, which could jeopardize the effectiveness and safety of these procedures. WO/2009/091497 discloses a device having the features of the preamble of claim 1.
The object of the present invention as claimed in claim 1, is to develop a device-system to reduce the possible complications due to the immature solutions or unsolved problems of NOTES, SPLS or IE, which allows easier, faster and safer completion of all steps of the NOTES, SPLS or IE procedures through the natural orifices similarly to the reliable and well developed laparoscopic technique. Preferred embodiments are disclosed in the dependent claims.
The present invention is based on the recognition that (i) the complex inner and outer ends of the device-system - acting as the continuation of each other - are considered as a unit having laparoscopic features, while the middle part - connecting the inner and outer ends together - is rather regarded as a unit with flexible endoscopic features, and that (ii) the movements of the inner and outer ends of the device - introduced with the help of a flexible endoscope-like device through the natural orifices - are synchronized to move at the same time and degree as they both were the inner and outer parts of a traditional laparoscopic instrument, and that (iii) an appropriately modified endoscopic stapler is used with the help of accessory devices attached to the device-system, will make it possible to perform all steps of NOTES, SPLS or IE procedures easier, faster and safer.
Furthermore a tube or an endoscopic device is disclosed capable to receive one or more surgical instruments and/or trocar sleeves, and the tube or the endoscopic device is designed to be able to deliver the inner ends of the instruments and/or the trocar sleeves to the operation field, and also the inner end of the tube or the endoscopic device is shaped to enable the proper fixation and triangulation of the surgical instruments and/or trocar sleeves.
Furthermore a wound closure device-system is disclosed, that according to its main concept contains an implanting tube attachable to other devices and an implanting sheath, there are locking elements and an implanting rod - that implanting rod is operable through its outer end and serves to release these locking elements out of the sheath - inside the implanting sheath, and there are threads connecting to each locking elements, and the threads are delivered through the longitudinal split of the sheath and the outer end of the tube, and advantageously the implanting tube, the sheath and the implanting rod are flexible.
Furthermore an endoscopic stapler is disclosed, which has a body portion and a head portion that are connected together advantageously with articulation, and also has opposed stapling surfaces on the head portion with a control thread - that allows tension or relaxation - extending between their free ends, and said thread is advantageously placed within a longitudinal channel formed inside the head and the body portions of the stapler.
Furthermore an endoscopic balloon tube is disclosed, which has two inflatable balloon rings located in an appropriate distance from each other, and has also at least one gas tube that allows to inflate the balloons, and said endoscopic balloon tube could be arranged on the inner region of one or more surgical instruments or one or more trocar sleeves or on the inner region of a tube or an endoscopic device that contains one or more surgical instruments or trocar sleeves.
Furthermore a catheter that can be inserted into the working channel of a trocar sleeve, tube or endoscopic device is disclosed, and said catheter has an electric unit - which is able to cut or coagulate tissues - mounted on the inner end advantageously on the tip of the catheter, said electric unit has an electrical wiring extending along the catheter, and said electrical wiring is connectable to an electric power supply.
According to an advantageous embodiment this force transmission unit is located inside the channel of the instrument and advantageously consists of ball shaped force transmission particles. The channel extends from the inner telescopic end through the middle part to the outer telescopic end. The full length of the channel is filled up with balls. The diameter of the ball is somewhat smaller than the inner diameter of the channel. Advantageously there are holes in the middle of the balls, and the motive wire travels through these holes from the handle to the head. Advantageously the channel is provided with antifriction material. Advantageously the ball like force transmission particles are able to pass easily through the channels at the articulations. When the handle of the instrument is pushed forward, the handle push the last ball in the channel of the outer telescopic end. The adjacent balls transfer this pushing force to one another, and at last the first ball in the channel of the inner end pushes forward the head of the instrument, resulting in the elongation of the inner telescopic end. To execute the movement in the opposite direction that is to reduce the length of the inner telescopic end, it is advantageous to utilize a wire that connects the two telescopic ends together, and for this purpose the motive wire is also acceptable. When pulling the handle of the instrument, the outer telescopic end becomes elongated and the wire - fixed to the handle - simultaneously pull in the inner telescopic end. If the free transmission is guaranteed, any other form distinct from the ball shape is suitable. The bendable connections among the force transmission particles, which are threaded by the motive wire, are designed to resist their compression along the longitudinal axis and to resist their torsion to each other around the longitudinal axis.
According to another advantageous embodiment the force transmission unit is a hydraulic unit advantageously with elastic capsule, and said hydraulic unit is located inside the channel described above. According to an advantageous embodiment, the hydraulic unit has three parts: the inner and the outer ends and the middle part. The three parts of the hydraulic unit communicate with one another and they form together one common cavity. This hydraulic unit is a closed system and the hydraulic fluid does not communicate with the outer environment, it only flows through the three parts of the common cavity. The middle part of the hydraulic unit is located advantageously in the channel of the middle part of the instrument, and their lengths are equal, and said middle part of the hydraulic unit is fixed to the channel in order to avoid shifting. The inner and the outer ends of the hydraulic unit are located inside the channels of the inner and the outer telescopic ends of the instrument. The inner and the outer ends of the hydraulic unit are advantageously designed to allow only longitudinal expansion or reduction along their longitudinal axis without any change in their diameter. The capsules of the ends of the hydraulic unit are advantageously able to move within the channels of the ends of the instrument along its longitudinal axis. One possible advantageous solution regarding the ends of the hydraulic unit would be the accordion like folding of the walls of both ends. When the outer telescopic end is compressed longitudinally because the handle of the instrument is pushed, the accordion shaped outer end of the hydraulic unit becomes simultaneously compressed along its longitudinal axis. Thereby the elevated pressure within the outer end of the hydraulic unit is transferred through the fixed hydraulic middle part to the inner hydraulic end resulting in the longitudinal expansion of the accordion folded inner hydraulic end that leads to the elongation of the telescopic inner end as well. Advantageously the extent of the elongation and the extent of the shortening are equal. Along with the accordion folded design, a similar result can be achieved, if the wall of the hydraulic unit is made of appropriately elastic material. To execute the movement in the opposite direction in order to reduce the length of the inner telescopic end, it is advantageous to utilize a wire that connects the two telescopic ends together, and for this purpose the motive wire is also acceptable. When pulling the handle of the instrument, the outer telescopic end becomes elongated and the wire - fixed to the handle - simultaneously pulls in the inner telescopic end.
The head situated on the inner end of the instrument can be rotated around the longitudinal axis. The rotation of the head is controlled by the rotation of the outer end of the instrument, advantageously without the need to rotate the handle. The rotation of the handle advantageously is independent from the rotation of the head. Advantageously the head located on the inner end and the outer end rotates with the same degree. The rotation of the head and the inner end by the outer end is executed via the connected force transmission particles - said connections among the particles resist to the torsion effects around the longitudinal axis as described before, or is executed via the flexible sheath that also resists to the.torsion effects around the longitudinal axis. Of course any other known solutions are acceptable with regard to the rotation of the head.
According to the simplest advantageous solution both ends of the tube are normal (i.e. straight). Advantageously the outer and the inner ends of the tube could be rigid and the middle part could be flexible. The inner diameter of the tube makes it possible to insert more than one - advantageously four - trocar sleeves. The inner surface of the tube could be completely smooth, or according to an advantageous embodiment, may have longitudinal connecting grooves or rails on the inner surface. Advantageously there could be longitudinal connecting grooves or rails also on the outer surface of the tube. A thread, a stick or a rod could be attached to the outer surface of the tube advantageously at the inner end region. There is advantageously a joint-like articulation between the inner end and the middle part of the tube. The inner end is bendable at the articulation relative to the middle part by the help of a pair of wires that extend longitudinally throughout the tube, and an articulating device mounted on the outer end of the tube. The opening of the inner end of the tube could be normal (i.e. straight), oblique or step-form. The inner opening is straight if the plane of the inner opening is perpendicular to the longitudinal axis of the tube. The inner opening is oblique if the plane of the inner opening is not perpendicular to the longitudinal axis of the tube. The inner opening is step-form, if the straight or oblique opening is combined together with an opening located on the side of the inner end of the tube (the plane of the side opening is advantageously parallel with the longitudinal axis). The step-form opening has a greater advantage because it significantly expands the size of the interventional area and assures the easier maneuvers. The greater the size of the opening of the inner end facing toward the operation field, the greater is the freedom of movements of the instruments. This opening area could be readily enlarged to the desired size by additionally increasing the size of the side opening component.
The enlarged diameter of the inner opening makes it possible to arbitrary increase the distance between the inner articulations of the instruments by pushing the instruments relative to one another along their longitudinal axis. The possible extent of the instruments dislocation is determined advantageously by the largest diameter of the inner opening. According to an advantageous solution, the direction of the largest diameter of the inner opening tends toward the direction of the longitudinal axis of the device. During laparoscopic surgery the intervention could be performed optimally only in case the operation field and the two operating instruments form a triangle with an appropriate wide base (this is the so called triangulation), and said base of the triangle is determined by the distance between the two instruments inserted into the abdominal cavity. In case of laparoscopic surgery the size of the triangle base - i.e. the distance between the two operating instruments - is alterable only if one of the instruments is removed and then reinserted through another location - i.e. new wound - into the abdominal cavity across the abdominal wall.
The size of the triangulation base could be altered (increased or decreased) without the need to create additional wounds across the abdominal wall. In case of oblique or step-form openings the size of the triangle base is determined by the largest diameter of the inner opening. The distance between the inner articulations of the instruments (i.e. the size of the triangle base) is optionally alterable (enlarge or reduce) by the relative shifts of the instruments along their longitudinal axis, depending on the largest diameter of the inner opening. In case of a tube or endoscopic device with a normal (straight) end the size of the triangle base is unfortunately small, contrarily the oblique or the step-form opened inner end provides with a significantly larger size. In addition the step-form opening is more advantageous than the oblique opening because it ensures the reliable connections - said connections allow movements along the longitudinal axis and rotation around the longitudinal axis - of at least two instruments or trocar sleeves to the tube or to the endoscopic device within the entire extent of the inner opening. The reliable connection between the instrument or the trocar sleeve and the inner end of the tube or the endoscopic device guarantees the appropriate stability to the inner end of the instrument or the trocar sleeve in order to perform the surgical intervention with safe maneuvers. It is a remarkable advantage that it allows the optional and stable alteration of the size of the triangle base without creating additional wounds, and furthermore allows the optional change in the position of the inner end of the tube or the endoscopic device (e.g. with a control rod) and the fixation of the inner end in the new position to ensure the optimal access to any operation field. For all these results the adjustable telescopic ends are also necessary, of course.
According to a possible advantageous solution the endoscopic device is divided. In this case the endoscopic device is partially or totally divided into two parts (upper and lower parts) by a plane that is advantageously parallel with the longitudinal axis. The two parts are connected together by sliding connection, and they are optionally movable back and forth along their longitudinal axis relative to each other. The dividing plane may divide the working channel inside the endoscopic device into two complementary divided working channels. When the two divided parts of the endoscopic device are shifted longitudinally relative to each other, the divided working channels become free at their inner ends. The instruments bent at their inner articulations are easily movable back and forth within the free part of the divided working channels with or without the trocar sleeves. The free part of the divided working channel is advantageous because it allows the telescopic inner end and head of the instrument - i.e. the part that is distal to the inner articulation - to exit from the divided working channel along the full length of its free part in order to reach the interventional area. The length of the free parts of the divided working channels could be changed optionally (increase or decrease) by shifting the two divided endoscopic parts longitudinally relative to one another. According to and advantageous arrangement of the four working channels, the plane dividing the endoscopic device into two longitudinal parts also divides longitudinally two opposite working channels. The other two working channels - advantageously the upper and the lower channels - remain intact. The normal or oblique inner ends of the divided endoscopic device could be transformed into a step-form inner end by the longitudinal shift of the two parts (advantageously only the upper part or only the inner part) relative to one another.
Advantageously the trocar shaft - i.e. the rigid tube-like continuation of the lower part - exits the common cylindrical end through the lower outer opening. The trocar shaft - provided with a valve - is the external continuation of the intact working channel located inside the lower endoscopic part, and said trocar shaft, which extends through the lower outer opening, has an ear-like handle at the outer end that helps to move the lower endoscopic part longitudinally back and forth. Advantageously the trocar shaft is shifted in and out through the lower outer opening of the common cylindrical end by the help of the ear-like handle, which consequently means the longitudinal back and forth movement of the inner end of the lower endoscopic part. Thereby the size of the step-form inner opening - and consequently the size of the interventional area - is optionally adjustable.
According to another possible solution, the outer ends of the divided endoscopic device are similarly divided as the inner ends, and both outer ends are hermetically sealed. The upper and lower outer ends have airtight outer openings with valves. In this case either endoscopic part - the upper and the lower endoscopic parts are connected together by sliding connection - could be removed from the patient and could be replaced with a larger instrument (e.g. an endoscopic stapler), or through the space of the removed endoscopic part also tissue or organ specimens could be removed.
Advantageously any type of tube or endoscopic device may have a protective sheath. The protective sheath is advantageously cone shaped and is made of a strong clingfilm-like material, that on the outer end has a connecting ring or tube - able to connect airtight to the outer end of a tube or an endoscopic device -, and on the inner end it has an expandable ring. The protective sheath covers the tube or the endoscopic device. The protective sheath is inserted via a natural orifice into the abdominal cavity through the wound on the wall of a hollow organ advantageously in a rolled position over the tube or the endoscopic device. When the protective sheath enters the abdominal cavity, the expanding cone shaped inner end with the expandable ring and the contracting wound around the protective sheath prevent to escape the gas from the insufflated abdominal cavity. In addition the protective sheath protects the wall of the hollow organs and the adjacent area against the injuries caused by the moving instruments, and prevents the contact with the contaminated secretions, or with the diseased tissues or organs. The cone shaped inner end (i.e. the inner end has a larger circumference) allows to remove the tissues or organs easier. Of course any other shape of the protective sheath could be among the possible solutions.
In any of the previously described instrument - trocar sleeve - tube or endoscopic device system, or instrument - trocar sleeve system, or instrument-tube or endoscopic device system the inserted instruments are able to reliably reproduce all three-dimensional laparoscopic maneuvers by the help of bandings, rotations and telescopic movements.
One of such accessory instrument is the access catheter, which enables to create a wound opening on the wall of a hollow organ (e.g. the stomach) during the access phase. The catheter could be inserted into any suitable working channels. There is an electric unit - that is able to cut or coagulate tissues - mounted on the inner end advantageously on the tip of the catheter, said electric unit has an electrical wiring extending along the catheter, and said electrical wiring is connectable to an electric power supply. The electric unit is slightly recessed within the tip of the catheter in order to avoid the direct contact with extended tissue areas. There are two consecutive balloons on the catheter. The one closer to the inner end has advantageously an umbrella-like shape characteristically with a diameter - that is perpendicular to the longitudinal axis - larger than that of the tube or the endoscopic device. The next one is the dilating balloon that has advantageously a cylinder-like shape and its diameter is smaller than that of the tube or the endoscopic device. The balloons are independently inflatable or deflatable, and their air ducts extend over the outer end of the tube or the endoscopic device.
Figure 1/A shows the possible solution of the joint-like articulation and its bending system according to the present invention,
Figure 1/B shows the possible solution of the telescopic instrument with the ball-like force transmission particles according to the present invention,
Figure 1/C shows the possible solution of the telescopic instrument with the hydraulic force transmission unit according to the present invention,
Figure 1/D shows the possible solution of the advantageously closed hydraulic unit,
Figure 1/E shows one possible solution for the ratcheting mechanism located at the region of the outer articulation,
Figure 1/F shows the cross section of the instrument with ball-like force transmission particles according to the present invention,
Figure 1/G shows the cross section of the instrument with hydraulic unit according to the present invention,
Figure 1/H shows the connecting ring attachable to the instrument according to the present invention,
Figure 1/I (on the drawing page 2/29) shows the longitudinal section of the instrument with a flexible sheath according to the present invention,
Figure 2/A shows a possible advantageous solution of the trocar sleeve according to the present invention,
Figure 2/B shows an advantageous solution of the telescopic instrument according to the present invention,
Figures 2/C and D show the ring with a connecting groove, thread and needle that is attachable to a telescopic instrument according to the present invention,
Figure 2/E shows the ratcheting mechanism located at the outer articulation,
Figures 3/A and B show one possible advantageous solution of the telescopic trocar sleeve according to the present invention,
Figure 3/C shows one possible solution of the instrument with flexible middle part according to the present invention,
Figure 3/D shows the ring attachable to the telescopic trocar sleeve according to the present invention,
Figure 3/E shows the ratcheting mechanism mounted on the outer articulation,
Figure 4/A shows an advantageous solution of the tube with straight inner end according to the present invention,
Figure 4/B shows an advantageous solution of trocar sleeves with sector-like cross sections that are connected together through sliding connections,
Figures 4/C, D and E show an advantageous solution of the inner ends of the telescopic trocar sleeves - with sector-like cross sections - that are connected together through sliding connections,
Figure 4/F shows the cross section of the trocar sleeves (having sector-like cross sections) within the tube,
Figure 4/G shows the cross section of the trocar sleeves (having sector-like cross sections) that are connected together through sliding connections,
Figure 5 shows the possible dimensions of the movements of the instrument and its similarity to the laparoscopic movements according to the present invention by illustrating the inner virtual end (dashed line) as the straight continuation of the outer end on the drawing,
Figures 6/A, B, C, D, E and F show one by one the possible dimensions of movements of the instrument according to the present invention,
Figure 7 shows a possible position of the laparo-endoscopic system inserted into a patient,
Figure 8 shows one possible position of the laparo-endoscopic system to perform the removal of the gall bladder,
Figure 9/A shows one advantageous solution of the tube with a step-form opened inner end,
Figure 9/B shows the oblique opened inner end of the tube,
Figure 9/C shows one possible solution of the tube with either an oblique or a step-form opened inner end,
Figure 9/D shows a possible solution of the endoscopic balloon tube that could be pulled over the tube,
Figure 9/E shows a possible solution of the cup that is able to hermetically seal the outer end of the tube,
Figure 9/F shows two possible cross sections of the tube,
Figure 10 shows an advantageous solution of the step-form opened inner end of the tube,
Figure 11 shows the suggested position of the laparo-endoscopic system with step-form opened inner end during gall bladder surgery, and the advantageous use of the control rod, respectively,
Figure 12/A shows an advantageous solution of the divided endoscopic device with normal (straight) inner ends and the protective sheath,
Figure 12/B shows the longitudinal sliding of the parts of the previous endoscopic device and the trocar shaft and the protective sheath,
Figures 12/C and D show the advantageously oblique inner ends of the divided endoscopic device in normal and in shifted positions, respectively,
Figure 12/E shows the possible elliptical cross section of the endoscopic device,
Figures 13/A and B show the longitudinal sections of the divided endoscopic device advantageously with oblique inner ends in normal and in shifted positions, respectively,
Figures 13/C and D show the advantageous cross sections of the divided endoscopic device,
Figure 13/E shows the cross sections of the instrument with a trocar sleeve or a connected ring that are insertable into the working channel of an endoscopic device,
Figures 14/A and B show the normal and the shifted positions of the normal (straight) inner ends of the upper and lower endoscopic parts each containing two intact working channels inside,
Figure 14/C shows the common cylindrical end of the previous endoscopic device with two trocar shafts and with the articulating device,
Figure 15 shows the already shifted upper and lower parts of the divided endoscopic device with oblique inner ends, each endoscopic parts containing two intact (non divided) working channels that are hermetically sealed at their outer ends, and the two independent parts are connected together by a longitudinal sliding connection,
Figures 16/A, B and C show additional advantageous variations of the connections of the trocar sleeves,
Figure 17/A shows the non divided endoscopic device with an oblique or step-form opened inner end,
Figure 17/B shows the cross section of the previous device,
Figure 17/C shows the oblique inner end of the non divided endoscopic device,
Figures 18/A and C show the device able to close the wound on a wall of a hollow organ,
Figure 19/A shows the instrument within a step-form opened tube just penetrating through the stomach,
Figure 19/B shows the camera introduced through the small wound,
Figures 20/A, B and C show another advantageous method with the access catheter to penetrate through the wall of a hollow organ,
Figure 21 shows a gall bladder operation by a laparo-endoscopic system having a step-form opened inner end, the fixation possibilities of the inner and the outer ends of the system, and the anatomical landmarks,
Figure 22 shows a SPLS (Single Port Laparoscopic Surgery) gall bladder operation through an abdominal port by surgical instruments with rigid ends and middle parts,
Figure 23 shows a SPLS (Single Port Laparoscopic Surgery) gall bladder operation performed with a laparo-endoscopic system having a rigid tube with step-form opened inner end,
Figure 24/A shows the laparo-endoscopic system with an oblique and step-form opened inner end and with a protective sheath that is introduced into the patient through a natural orifice,
Figure 24/B shows the removal of the gall bladder by the help of the laparo-endoscopic system throughout the protective sheath,
Figure 25 shows an appendicectomy operation by a laparo-endoscopic system having a step-form opened inner end, the fixation possibilities of the inner and the outer ends of the system, and the anatomical landmarks,
Figures 26/A and B show an appendicectomy operation performed with a laparo-endoscopic system having an oblique and step-form opened inner end and with an endoscopic stapler, and the removal of the appendix throughout the protective sheath,
Figure 27 shows the closure procedure of the wound on the wall of a hollow organ by the help of a tube having step-form opened inner end and a camera, and by the help of the wound closure device attached to the tube,
Figure 28 shows the wound closure device with a camera attached to the tube that is turned around within the wound of a hollow organ during the closure process,
Figure 29/A shows the threads with locking elements that are inserted circumferentially into the wound edges of the hollow organ, and the implanting tube,
Figure 29/B shows the threads with locking elements that are inserted around a pathological lesion of a hollow organ, and the implanting tube,
Figure 29/C shows the contracted wound edges pulled up into the tube by the threads, and the elevated wound edges,
Figure 30/A shows a laterally opening straight endoscopic stapler advantageously with a control thread and a camera that is inserted through the mouth along the implanting tube,
Figure 30/B shows the contracted and elevated wound edges or the elevated pathologic lesion of the bowel wall that are pulled among the stapling surfaces by the threads and the implanting tube, and also the control thread under tension,
Figure 30/C shows the closed wound of the hollow organ by a stapler, and also the implanting tube and the removed tissue,
Figure 30/D shows according to another possible solution of the endoscopic stapler with a control thread and a connecting groove,
Figures 31/A, B and C show a wound closure process with a laterally opening curved endoscopic stapler,
Figure 32/A shows a front opening straight endoscopic stapler bent at the articulation having a control thread and a connecting groove,
Figure 32/B shows the contracted and elevated wound edges or the elevated pathologic lesion of the bowel wall that are pulled by the threads and the implanting tube among the stapling surfaces of a front opening endoscopic stapler, that is bent at its articulation, and also has a control thread and a camera attached by sliding connection,
Figures 33/A and B show the excision of the tissue pulled into the stapler and also the stapled closure of the wall of the hollow organ, and finally
Figures 34/A and B show the full excision of the pathological lesion located on the wall of a hollow organ and also the closure of the wound with sutures by the help of a laparo-endoscopic system.
According to an advantageous embodiment hereof, the surgical instrument 6 (e.g. Fig. 1/B) is inserted into the trocar sleeve 7, and the trocar sleeves 7 (e.g. Fig. 3/A and B) are inserted into the partially or totally flexible tube 28 (Fig. 9/A) or endoscopic device 66, 103 (Fig. 15, 17). Advantageously the connections between the tube 28 or the endoscopic device 66, 103 and the trocar sleeves 7 and the surgical instruments 6 allow both longitudinal and rotational movements (e.g. Fig. 11). If required further accessory devices (e.g. protector sheath 71 - e.g. Fig. 15, wound closure device - Fig. 18, endoscopic stapler 88 - e.g. Fig. 30) could be attached to their inner or outer surfaces. Advantageously all connections allow longitudinal movement or sliding along the longitudinal axis and rotation around the longitudinal axis, respectively.
As the figures 1/B and C show, according to an advantageous embodiment of the surgical instruments 6, the surgical instrument 6 advantageously consists of three parts: the partially flexible middle part 2 and the two telescopically extendable rigid inner 1 and outer 3 ends, and said inner 1 and outer 3 ends are connected to the middle part 2 through joint-like articulations 4. Advantageously the segments of the middle part 2 adjacent to the articulations 4 are also rigid. The cross section of the instrument 6 is advantageously circular.
The head 8 situated on the inner end 1 of the instrument 6 is rotatable around the longitudinal axis (Fig. 5 and 6/E). The rotation of the head 8 is controlled by the rotation of the outer end 3 of the instrument 6, advantageously without the need to rotate the handle 9. The rotation of the handle 9 advantageously is independent from the rotation of the head 8. Advantageously the head 8 located on the inner end 1 and the outer end 3 rotates with the same degree. The rotation of the head 8 and the inner end 1 by the outer end 3 is executed via the connected force transmission particles 12 - said connections among the particles 12 resist to the torsion effects around the longitudinal axis as described before, or is executed via the flexible sheath 108 that also resist to the torsion effects around the longitudinal axis. Of course any other known solutions are acceptable that allow rotation of the head 8.
According to an advantageous embodiment this force transmission unit is located inside the channel of the instrument 6 and advantageously consists of ball shaped force transmission particles 12 (Fig. 1/B). The channel extends from the inner telescopic end 3 through the middle part 2 to the outer telescopic end 3. The full length of the channel is filled up with balls 12. The diameter of the ball is somewhat smaller than the inner diameter of the channel. Advantageously there are holes in the middle of the balls 12, and the motive wire 13 travels through these holes from the handle 9 to the head 8. Advantageously the channel is provided with antifriction material. Advantageously the ball like force transmission particles 12 are able to pass easily through the channels at the articulations 4. When the handle 9 of the instrument 6 is pushed forward, the handle 9 push the last ball 12 in the channel of the outer telescopic end 3. The adjacent balls 12 transfer this pushing force to one another, and at last the first ball in the channel of the inner end 1 pushes forward the head 8 of the instrument 6, resulting in the elongation of the inner telescopic end 3. To execute the movement in the opposite direction that is to reduce the length of the inner telescopic end 1, it is advantageous to utilize a wire that connects the two telescopic ends 1, 3 together, and for this purpose the motive wire 13 is also acceptable. When pulling the handle 9 of the instrument 6, the outer telescopic end 3 becomes elongated and the wire 13 - fixed to the handle 9 - simultaneously pull in the inner telescopic end 1. If the free transmission is guaranteed, any other form distinct from the ball shape is suitable. The bendable connections among the force transmission particles 12, which are threaded by the motive wire 13, are designed to resist their compression along the longitudinal axis and to resist their torsion to each other around the longitudinal axis.
According to another advantageous embodiment the force transmission unit is a hydraulic unit 14 advantageously with an elastic capsule, and said hydraulic unit 14 is located inside the channel described above (Fig. 1/D). According to an advantageous embodiment, the hydraulic unit 14 has three parts: the inner 16 and the outer 17 ends and the middle part 15. The three parts of the hydraulic unit 14 communicate with one another and they form together one common cavity. This hydraulic unit 14 is a closed system and the hydraulic fluid does not communicate with the outer environment, it only flows through the three parts of the common cavity. The middle part 15 of the hydraulic unit is located advantageously in the channel of the middle part 2 of the instrument 6, and their lengths are equal, and said middle part 15 of the hydraulic unit 14 is fixed to the channel in order to avoid shifting. The inner 16 and the outer 17 ends of the hydraulic unit 14 are located inside the channels of the inner 1 and the outer 3 telescopic ends of the instrument 6. The inner 16 and the outer 17 ends of the hydraulic unit 14 are advantageously designed to allow only longitudinal expansion or reduction along their longitudinal axis without any change in their diameter. The capsules of the ends 16, 17 of the hydraulic unit 14 are advantageously able to move within the channels of the ends 1, 3 of the instrument 6 along its longitudinal axis. One possible advantageous solution regarding the ends 16, 17 of the hydraulic unit 14 would be the accordion like folding of the walls of both ends 16, 17. When the outer telescopic end 3 is compressed longitudinally because the handle 9 of the instrument 6 is pushed, the accordion shaped outer end 17 of the hydraulic unit 14 becomes simultaneously compressed along its longitudinal axis. Thereby the elevated pressure within the outer end 17 of the hydraulic unit 14 is transferred through the fixed hydraulic middle part 15 to the inner hydraulic end 16 resulting in the longitudinal expansion of the accordion folded inner hydraulic end 16 that leads to the elongation of the telescopic inner end 1 as well. Advantageously the extent of the elongation and the extent of the shortening are equal. Along with the accordion folded design, a similar result can be achieved, if the wall of the hydraulic unit 14 is made of appropriately elastic material. To execute the movement in the opposite direction in order to reduce the length of the inner telescopic end 1, it is advantageous to utilize a wire that connects the two telescopic ends 1, 3 together, and for this purpose the motive wire 13 is also acceptable. When pulling the handle 9 of the instrument, the outer telescopic end 3 becomes elongated and the wire 13 - fixed to the handle 9 - simultaneously pulls in the inner telescopic end 1.
On the middle part 2 of the instrument at least one connecting ring 10 is placed advantageously to connect between the tube 28 and the instrument 6 (Fig. 1/H and 2/C). The instrument 6 is easily rotatable within the ring 10. There is a connecting groove 11 formed on the outer surface of the ring 10. According to another advantageous solution, a thread 23 with needle 24 is connected to the ring 10 which helps to fix of the middle part 2 of the instrument 6 to any part of the abdominal wall 41 (Fig. 2/D and 8).
According to another advantageous embodiment the instrument 6 is attachable to the tube 28 through a simple trocar sleeve 7 (Fig. 4/A and 4/F). There is a sliding connection 29 between the tube 28 and the trocar sleeve 7, and the middle part 2 of the instrument 6 is located in the trocar sleeve 7. The middle part 2 of the instrument 6 is advantageously longer than the trocar sleeve 7. The instrument 6 is rotatable and back and forth slideable within the trocar sleeve 7. Advantageously there is a valve 22 and an airtight ring 21 on the outer end 3 of the trocar sleeve 7 (Fig. 4/E). The cross section of the trocar sleeve 7 could have a sector-like form. The trocar sleeve 7 could be rigid or flexible.
An instrument 6 constructed this way is connected to the tube 28 advantageously through a trocar sleeve 7 which has a partially or totally flexible middle part 2 and with articulations 4 connected rigid telescopic outer 3 and inner 1 ends (Fig. 3/A and 3/B). The simultaneous bandings of the articulations 4 as described earlier are executed by the antagonistic wires 5 situated within the wall of the trocar sleeve 7. Similarly, the ratchet mechanism 18 could be formed on the outer articulation 4 (Fig. 3/E). The simultaneous elongation and shortening of the telescopic ends 1, 3 of the trocar sleeve 7 are the results of the forward or backward movements of the instrument 6 within the trocar sleeve 7. Advantageously there is a sliding connection 29 between the trocar sleeve 7 and the tube 28, which allows free movements along the longitudinal axis. Advantageously the sliding connection 29 is accomplished by at least one connecting ring 10 situated on the middle part 2 of the trocar sleeve 7, and said ring 10 is freely rotateable around the middle part 2 (Fig. 3/D). Advantageously the ring 10 has a connecting groove 11 that is connected with the rail 50 mounted on the inner surface of the tube 28 (e.g. Fig. 10). There is an airtight valve 22 and a ring 21 on the outer end 3 of the trocar sleeve 7 (Fig. 3/A and 3/B).
According to this possible solution, to the trocar sleeves 7 with sector cross sections, and with rigid outer 3 and inner 1 telescopic ends are advantageously attached through articulations 4 (Fig. 4/C and 4/D). Advantageously the cross sections of the telescopic ends 1, 3 are round, and said ends 1, 3 are rotatable relative to the middle part 2 around the longitudinal axis. In this case there is no force transmission unit to actuate the telescopic ends 1, 3. This telescopic function is executed by the surgical instrument 6 located within the working channel 27 of the telescopic trocar sleeve 7, and said instrument 6 has a flexible middle part 6 and rigid outer 26 and inner ends 25 (Fig. 3/C), and is able to move longitudinally forth and back within the working channel 27. The simultaneous bending of the telescopic ends 1, 3 at their articulations 4 are advantageously directed by a pair of antagonistic wires 5 located within the trocar sleeve 7. At the outer end 3 of the trocar sleeve 7 there is an airtight valve 22 and a sealing ring 21.
According to an advantageous embodiment, the additional trocar sleeves 7 are connected to the outer surface of a double trocar sleeve 99 through sliding connections 29(Fig. 16/A). Advantageously the trocar sleeves 7 are attached to the junction part of the double trocar sleeve 99. In addition further connecting grooves 11 or rails 50 could be formed on the outer surfaces of the double trocar sleeve 99 or on the additionally attached trocar sleeves 7 to connect them e.g. with a thread 23, stick 51 or rod 61 to ensure their fixation to the abdominal wall 41 (similar to Fig. 8 and 11).
According to another advantageous embodiment, the trocar sleeves 7 are connected to the outer surface of a trocar guide 98 through sliding connections 29 (Fig. 16/B). The connecting grooves 11 or rails 50 are mounted on the outer surface of the trocar guide 98. Inside the trocar guide 98 a smaller diameter working channel 27 could be situated, which could be used to insert e.g. a ballooned access catheter 104 (Fig. 20/A, 20/B and 20/C). The inner end of the trocar guide 98 is advantageously sharp.
The trocar sleeves 7 connected together by sliding connections 29 (Fig. 4/B, C, D and G) are also insertable into the abdominal cavity or fixable to the abdominal wall 41 by the help of a partially or totally flexible simple tube 28 (Fig.4/A). In this case there is no groove 11 or rail 50 formed inside the tube 28, they are formed only on the outer surface of the tube 28 (Fig. 4/F). The inner end opening 31 of the tube 28 may have a normal 102 (i.e. flat), oblique 101 or step-form 100 shape (Fig. 4/A and 9/A, B and C). There may be a thread 23 (Fig. 2/D), stick 51 (Fig. 4/A) or rod 61 (Fig. 11) connected to the outer surface of the inner end 52 of the tube, each of them allowing to fix the tube 28 to the abdominal wall 41. The stick 51 may have a connecting foot 58 that fits into the advantageously longitudinally situated connecting groove 11 on the outer surface of the tube 28, and said connecting foot 58 is slideable within the groove 11 (Fig. 10). In this case the inner end 52 of the tube 28, which is fixed to the abdominal wall 41 with the stick 51, is slideable back and forth by the help of the connecting foot 58, thereby allowing the proper adjustment of the inner end 52 over the designated operating field. At the same time by the help of the rigid stick 51 or rod 61 the inner end 52 of the tube 28 is easily maneuverable to any desired part of the intraabdominal cavity, or is fixable in any desired location and position, respectively (Fig. 11). Of course several other outer endoscopic devices 30 (e.g. wound closure device, camera 44, forceps, etc.) could be connected to the groove 11 located on the outer surface of the tube 28 (e.g. Fig. 27).
The tube 28 refers to a solution, which has a long cylindrical body advantageously with one single lumen inside, and into this lumen surgical instruments 6, trocar sleeves 7 or other accessory devices could be inserted (Fig. 4/A and 9/A).
According to the simplest advantageous solution both ends 52, 53 of the tube 28 are normal (i.e. straight) 102, and its cross section is round or elliptical (Fig. 4/A). Advantageously the outer 53 and the inner ends 52 of the tube 28 could be rigid and the middle part 2 could be flexible or could be rigid (similar to Fig. 23) if required. The inner diameter of the tube 28 makes it possible to insert more than one - advantageously four - trocar sleeves 7. The inner surface of the tube 28 could be completely smooth, or according to an advantageous embodiment, may have longitudinal connecting grooves 11 or rails 50 on the inner surface (Fig. 9/F). Advantageously there could be longitudinal connecting grooves 11 or rails 50 also on the outer surface of the tube 28. A thread 23 (Fig. 2/D), a stick 51 (Fig. 4/A) or a rod 61 (Fig. 11) could be attached to the outer surface of the tube 28 advantageously at the inner end 52 region. There is advantageously a joint-like articulation 4 between the inner end 52 and the middle part 2 of the tube 28 (Fig. 9/A). The inner end 52 is bendable at the articulation 4 relative to the middle part 2 by the help of a pair of wires 5 that extend longitudinally throughout the tube 28, and an articulating device 54 mounted on the outer 53 end of the tube 28. The opening 31 of the inner end 52 of the tube 28 could be normal 102 (i.e. straight) Fig. 4/A, oblique 101 (Fig. 9/B) or step-form 100 (Fig. 9/A and C). The inner opening 31 is straight 102 if the plane of the inner opening 31 is perpendicular to the longitudinal axis of the tube 28. The inner opening 31 is oblique 101 if the plane of the inner opening 31 is not perpendicular to the longitudinal axis of the tube 28. The inner opening 31 is step-form 100, if the straight 102 or oblique 101 opening is combined together with an opening located on the side of the inner end 52 of the tube 28 (the plane of the side opening is advantageously parallel with the longitudinal axis). The step-form opening 100 has a greater advantage because it significantly expands the size of the interventional area and assures the easier maneuvers.
In case of either solution referred above an optional external fixateur device 42 could be attached (e.g. Fig. 21, 23 or 25) to the outer end of any instrument 6, trocar sleeve 7, tube 28 (e.g. Fig. 4/A and 9/A) or endoscopic device 66, 103 (e.g. Fig. 15 or 17/A), and said external fixateur device 42 is able to fix the outer end transiently or permanently in a desired position.
In case of either solution above the inner end of any instrument 6, trocar sleeve 7, tube 28 or endoscopic device 66, 103 could be fixed via a thread 23 (Fig.2/D), or a stick 51 (Fig. 4/A) or a control rod 61 (Fig. 11), being attached to the inner end, to the abdominal wall and/or to an external fixateur device 42.
The endoscopic device 66, 103 refers to a solution, which has a long cylindrical body advantageously with round or elliptical cross section and with more than one working channels 27 inside (Fig. 12, 13, 14, 15 and 17). The elliptical cross section is advantageous, because the distance between the two lateral working channels 27 could be larger (Fig. 12/E) which allows easier maneuvers to the instruments 6 within these two working channels 27. Advantageously there could be connecting grooves 11 or rails 50 formed on the outer surface of either type of endoscopic device 66, 103 in order to establish additional external connections (e.g. with a thread 23, stick 51, control rod 61, stomach closure device, etc.). According to an advantageous embodiment there could be an articulation 4 formed at the inner end of either type of endoscopic device 66, 103, and said articulation 4 is bent by a pair of wires 5 and an articulating device 54. This pair of wires 5 extends through the entire endoscopic device 66, 103 and is connected to the articulating device 54 located at the outer end of the endoscopic device 66, 103. The inner and the outer ends of either type of endoscopic device 66, 103 are advantageously rigid and the middle part could be flexible or rigid. Either endoscopic device 66, 103 may have optionally a gas channel 64 and a suction-irrigation channel 65.
According to a possible advantageous solution the endoscopic device 66 is divided (Fig. 12 and 15). In this case the endoscopic device 66 is partially or totally divided into two parts (upper and lower parts) by a plane that is advantageously parallel with the longitudinal axis. The two parts are connected together by sliding connection 29, and they are optionally movable back and forth along their longitudinal axis relative to each other. The dividing plane may divide the working channel 27 inside the endoscopic device 66 into two complementary divided working channels 70 (Fig. 12). When the two divided parts of the endoscopic device 66 are shifted longitudinally relative to each other, the divided working channels 70 become free at their inner ends. The instruments 6 bent at their inner articulations 4 are easily movable back and forth within the free part of the divided working channels 70 with or without the trocar sleeves 7. The free part of the divided working channel 70 is advantageous because it allows the telescopic inner end 1 and head 8 of the instrument 6 - i.e. the part that is distal to the inner articulation 4 - to exit from the free part of the divided working channel 70 along its full length in order to reach the interventional area. The length of the free parts of the divided working channels 70 could be changed optionally (increase or decrease) by shifting the two divided endoscopic parts longitudinally relative to one another (Fig. 12). According to and advantageous arrangement of the four working channels 27, the plane dividing the endoscopic device 66 into two longitudinal parts also divides longitudinally two opposite working channels 70. The other two working channels 27 - advantageously the upper and the lower channels - remain intact. The normal 102 (Fig. 12/A) or oblique 101 (Fig 12/C) inner ends of the divided endoscopic device 66 could be transformed into a step-form 100 (Fig. 12/B and D) inner end by the longitudinal shift of the two parts (advantageously only the upper part or only the inner part) relative to one another, in order to achieve the advantages discussed above.
According to a possible advantageous embodiment the outer end of the divided endoscopic device 66 is rigid. The rigid end of the upper part of the device 66 is completed to a full cylinder, in such a way, that the rigid end of the slideable lower part is also inside the cylinder (Fig. 12/A): The outer end completed to a full cylinder is airtight and has advantageously four air proof openings 48 with valves 22, and said openings 48 are the inlet openings of the intact 27 or divided 70 working channels situated within the endoscopic device 66. The airtight closure of the cylindrical common end 67 may be also achieved by an optionally securable cap 47 with airtight inlet openings 48 and valves 22 (e.g. similar to Fig. 9/E).
Advantageously the trocar shaft 68 - i.e. the rigid tube-like continuation of the lower part - exits the common cylindrical end 67 through the lower outer opening 48 (Fig. 13/A and B). The trocar shaft 68 - provided with a valve 22 - is the external continuation of the intact working channel 27 located inside the lower endoscopic part, and said trocar shaft 68, which extends through the lower outer opening 48, has an ear-like handle 69 at the outer end that helps to move the lower endoscopic part longitudinally back and forth. Advantageously the trocar shaft 68 is shifted in and out through the lower outer opening 48 of the common cylindrical end 67 by the help of the ear-like handle 69, which consequently means the longitudinal back and forth movement of the inner end of the lower endoscopic part. Thereby the size of the step-form inner opening 100 - and consequently the size of the interventional area - is optionally adjustable.
According to another possible solution, the outer ends of the divided endoscopic device 66 are similarly divided as the inner ends, and both outer ends are hermetically sealed (Fig. 15). The upper and lower outer ends have airtight outer openings with valves 22. In this case either endoscopic part - the upper and the lower endoscopic parts are connected together by sliding connection 29 - could be removed from the patient and could be replaced by a larger endoscopic tool (e.g. an endoscopic stapler 88 similarly to Fig. 26/A), or through the space of the removed endoscopic part tissue or organ specimens could be removed as well.
Inside the divided working channels 70 of any type of endoscopic device 66, 103 there are sliding connections 29 (e.g. sliding rim 74, connecting groove 11 or rail 50) allowing the proper attachment and fixation, and the longitudinal back and forth movement of the inserted trocar sleeve 7 or instrument 6 (e.g. Fig. 13/C, D and 17/B). This connecting components (e.g. sliding rim 74, connecting groove 11 or rail 50) are connected to the connecting components (e.g. groove 75 on Fig.13/E) of the instruments 6 or the trocar sleeves 7.
The outer end of any type of tube 28 or endoscopic device 66, 103 may have a cone shape 105 (Fig. 21 and 25). This is advantageous because it allows the easier handling of the outer ends 3 of the instruments 6
In any of the previously described instrument 6 - trocar sleeve 7 - tube 28 or endoscopic device 66, 103 system, or instrument 6 - trocar sleeve 7 system, or instrument 6 - tube 28 or endoscopic device 66, 103 system the inserted instruments 6 are able to reliably reproduce all three-dimensional laparoscopic maneuvers by the help of bandings, rotations and telescopic movements.
Hereinafter come the descriptions of further accessory devices.
The first such accessory device could be a protective sheath 71 attachable to the outside of connected trocar sleeves 7, tube 28 or endoscopic device 66, 103 (Fig. 12/A and B). The protective sheath 71 is advantageously cone shaped and is made of a strong clingfilm-like material, that on the outer end has a connecting ring 73 or tube 97 - able to connect airtight to the outer end 53 of a tube 28 or an endoscopic device 66, 103 -, and on the inner end it has a self-expandable ring 72. The protective sheath 71 covers the tube 28 or the endoscopic device 66, 103. The protective sheath 71 is inserted via a natural orifice into the abdominal cavity through the wound 40 on the wall of a hollow organ 39 advantageously in a rolled position over the tube 28 or the endoscopic device 66, 103. When the protective sheath 71 enters the abdominal cavity, the expanding cone shaped inner end with the self-expandable ring 72 and the contracting wound 40 around the protective sheath 71 prevent to escape the gas from the insufflated abdominal cavity (e.g. Fig. 24/A). In addition the protective sheath 71 protects the wall of the hollow organs 39 and the adjacent area against the injuries caused by the moving instruments 6, and prevents the contact with the contaminated secretions, or with the diseased tissues or organs. The cone shaped inner end (i.e. the inner end has a larger circumference) allows to remove the tissues or organs easier. Of course any other shape of the protective sheath 71 could be among the possible solutions.
The second such accessory device could be an endoscopic balloon tube 56 with independently inflatable balloons 45, which could be placed advantageously on the inner end region of the connected trocar sleeves 7, tube 28 or endoscopic device 66, 103 (Fig. 9 and 19/A). This device 56 is placed into the wound 40 on the wall of a hollow organ 39 (similar to Fig. 22), in order to prevent gas leakage. When the endoscopic balloon tube 56 is already inserted, the air ducts 57 of the balloons 45 extend over the natural orifice.
The third such accessory device could be an access catheter 104, that enables to create a wound opening 40 on the wall of a hollow organ 39 (e.g. the stomach) during the access phase (Fig. 20/A, B and C). The catheter 104 could be inserted into any suitable working channels 27, 70. There is an electric unit 76 - that is able to cut or coagulate tissues - mounted on the inner end advantageously on the tip of the catheter 104, said electric unit 76 has an electrical wiring extending along the catheter 104, and said electrical wiring is connectable to an electric power supply. The electric unit 76 is slightly recessed within the tip of the catheter 104 in order to avoid the direct contact with extended tissue areas. There are two consecutive balloons 77, 78 on the catheter 104. The one 77 closer to the inner end has advantageously an umbrella-like shape characteristically with a diameter - that is perpendicular to the longitudinal axis - larger than that of the tube 28 or the endoscopic device 66, 103. The next one is the dilating balloon 78 that has advantageously a cylinder-like shape and its diameter is smaller than that of the tube 28 or the endoscopic device 66, 103. The balloons 77, 78 are independently inflatable or deflatable, and their air ducts extend over the outer end of the tube 28 or the endoscopic device 66, 103.
The fifth such accessory device could be assembled advantageously by rigid components, and allows the optional fixation of the outer and the inner ends of a trocar sleeve 7, tube 28 or endoscopic device 66, 103 (e.g. Fig. 21, 23 and 25). One end of this fixateur device 42 is fixed independently from the patient, e.g. to the operating table. One type of the external fixateur device 42 could be suitable to fix the thread 23, or stick 51 or rod 61 connected to the outer surface of the inner ends, while another type of the device 42 is suitable to fix the outer ends. The shape, the angle and the position of the fixateur device 42 could be secured or changed optionally. The fixation of the inner end makes possible to simultaneously lift the abdominal wall 41. In addition, the fixation of the inner end to the abdominal wall 41 could be executed by the help of a magnetic device 107 (Fig. 23).
The functions of the laparo-endoscopic system which is developed to accomplish all steps of the new surgical interventions (access, surgical intervention, and closure) of NOTES (Natural Orifice Transluminal Endoscopic Surgery), SPLS (Single Port Laparoscopic Surgery) and IE (Interventional Endoscopy) are as follows:
According to an advantageous solution, the protective sheath 71 is placed over the tube 28 and first it is attached to the outer surface of the tube 28 (e.g. Fig.9/A), then it is rolled over the body of the tube 28, finally a part of the expandable ring 72 is pulled into the inner opening 31 of the tube 28 by the help of an inserted instrument 6. The trocar sleeves 7 are introduced into the tube 28 by the help of sliding connections 29. A camera 44 is placed into the working channel 27 of the lower trocar sleeve 7 (fig. 19 and 20), and the access catheter 104 into the upper trocar sleeve 7. Thereafter the appropriately assembled flexible device system is introduced through the patient's natural orifice, actually through the mouth and the esophagus 38 into the stomach 39. It is advantageous to create the opening 40 on the anterior wall of the stomach 39. For this reason it is advantageous to use a tube 28 with a step-form opened 100 rigid inner end 52, and said inner end 52 could be bent at the articulation 4 perpendicularly toward the wall of the stomach 39 by the help of an articulating device 54 and wires 5. The tip of the inner end 52 is pushed against the stomach wall 39, and then the access catheter 104 is pushed forward within the upper trocar sleeve 7 (fig. 20). By activating the electric unit 76 within the tip of the access catheter 104, the forward moving catheter 104 passes through the stomach wall 39 at the desired point due to the developing thermal effect. Then the catheter 104 is pushed forward until the umbrella-like protective balloon 77 enters the abdominal cavity. At this point the protective balloon 77 is inflated, and it is pulled against the outer surface of the stomach wall 39 by pulling the whole catheter 104 outward. In this position the dilating balloon 78 is just in the stomach wall 39. Now the dilating balloon 78 is insufflated to reach a diameter that is less than the diameter of the tube 28, then the balloon 78 is desufflated, thereafter the step-form opened 100 inner end 52 of the tube 28 with gradually increasing diameter is pushed through the dilated wound 40 into the abdominal cavity until the expandable ring 72 of the rolled protective sheath 71 enters the abdominal cavity. Then the expandable ring 72 is expelled out of the inner end 52 of the tube 28 into the abdominal cavity with an instrument 6, and so the inner opening of the advantageously cone-shaped protective sheath 71 expands, and the protective sheath 71 is compressed to the tube 28 by the wound (fig. 24/A). These two effects prevent gas leakage through the wound opening 40. The expandable ring 72 prevents the inadvertent removal of the protective sheath 71. The airtight connecting ring 73 or tube 97 situated on the outer end of the protective sheath 71 prevents gas leakage at the outer end of the device system. The outer ends of the trocar sleeves 7, tubes 28 or endoscopic devices 66, 103 are sealed hermetically.
The access procedure is the same if an endoscopic device 66, 103 is used (e.g. Fig. 12, 15 and 17).
In case of an SPLS intervention the access procedure is performed via the navel, advantageously similarly to the laparoscopic technique. A small umbilical incision is made and under direct eye-control a laparo-endoscopic system is inserted into the abdominal cavity. This system consists of advantageously rigid trocar sleeves 7, rigid tube 28 or endoscopic device 66, 103, and is also provided with a protective sheath 71 or an abdominal port 81 (Fig. 22 and 23). It is enough to fix the outer end of the rigid system to an external fixateur 42.
This is the most important part of the whole intervention: to remove or to cure the diseased organs or tissues. The procedure performed with the laparo-endoscopic system is similar to the well developed laparoscopic technique. The inner end 52 of the device system is fixed above the operation field through the abdominal wall 41 to an external fixateur 42 (Fig. 21 and 25) by the help of a thread 23 (Fig. 2/D), a stick 51 (Fig. 4/A and B) or a control rod 61 (Fig. 11). The abdominal wall 41 could be lifted with the fixed inner end 52, thereby preventing the collapse of the abdominal cavity over the operation field in case of a gas leakage, and that makes the intervention much safer. The outer end 53 of the system is fixed to another external fixateur 42. It is advantageous, if the appropriately flexible middle part 2 of the system is bent only slightly. The positions of the instruments 6, which are inserted through the working channels 27, are adjusted by the help of the articulations 4, the telescopic ends 1, 3, the sliding connections 29 or the control rod 61. The inner 1 and the outer 3 ends of the instrument 6 inside the tube 28 are moving similarly as the inner and outer components of a traditional laparoscopic instrument (with the only difference that they are separated by the middle 2 part), thus the intervention could be performed similar to the laparoscopic technique, where one single instrument 6 is controlled by only one hand (e.g. gall bladder operation 34 or appendicectomy 80 - Fig. 21 and 25). If the size of the operation field is changed during the procedure, the position of the inner end 52 could be also adjusted, depending on the type of the fixation. In case of a thread 23 or a stick 51 the position could be changed by stitching through the abdominal wall 41 at another point. It is easier to use a control rod 61 (Fig. 11) because it is strong and rigid enough to simply move the inner end 52 of the device system from an earlier position to a newer one. The advantage of the control rod 61 could be increased, if it is inserted into the abdominal cavity through the umbilicus 60 (advantageously by the visual control of the camera 44 of the device system) and is attached to the inner end 52 of the tube 28. With this method it is possible to deliver the inner end 52 of the system to any area of the abdominal cavity and to fix it in the new position, thereby even the extending operations could be performed without creating any additional wounds. This technique makes it possible to perform any kind of interventions within the body cavities.
The gall bladder 34 or the appendix 80 are removed from the abdominal cavity advantageously through the tube 28, and if the tube has a cap 47 on the outer end 53, the cap 47 should be removed (e.g. Fig. 9/E). If the tissue or organ is larger then the inner diameter of the tube 28, they are removed through the protective sheath 71 by pulling them into the sheath 71 with an instrument 6 inside the tube 28 (Fig. 24/B and 26/B). The protective sheath 71 makes it possible to easily insert the previously removed laparo-endoscopic system back into the abdominal cavity.
When performing SPLS interventions, the rigid instruments 6, trocar sleeves 7, tube 28 or endoscopic device 66, 103 are inserted through the umbilicus 60, and their inner ends are directed toward the operation field (Fig. 22 and 23). The outer end of the device system could be fixed in the right position by an external fixateur 42. The further steps of the intervention are similar to the laparoscopic technique. In case of a rigid device system there is no need to fix the inner end, however on request it is executable with a thread 23, a stick 51 or a control rod 61, as discussed earlier.
The closure means primarily the reliable closure of a wound opening 40 on the wall of a hollow organ 39. As soon as the surgical intervention is completed, and the diseased organ or tissues are removed, and the operation field is checked again, the protective sheath 71 or the endoscopic balloon tube 56 are removed through the mouth, while the inner ends of the connected trocar sleeves 7, or the inner end of the tube 28 or the endoscopic device 66, 103 remain within the abdominal cavity. Within the inner end opening there is advantageously a single camera 44 in a curved position, which makes the visual control in the adjacent region of the wound 40 possible. A wound closure system is attached with sliding connection 29 (advantageously through a connecting groove 11 or rail 50) to the outer surface of the connected trocar sleeves 7, or the tube 28 or the endoscopic device 66, 103. The implanting tube 85 with the implanting sheath 82, locking elements 84, threads 23 and camera 44 inside is pushed against the stomach wall 39. The appropriate distance between the laparo-endoscopic system and the connected implanting tube 85 allows to the locking elements 84 and the threads 23 to reliably hold the lifted wound edges 40. Controlled by the camera 44 of the implanting tube 85 the pointed shaped inner end of the implanting sheath 82 is pushed through the wall of the hollow organ 39, and by pushing the implanting rod 83 a locking element 84 with thread 23 is discharged (Fig. 18/C). The movement of the implanting sheath 82 through the stomach wall 39 and the correct position of the locking elements 84 are controlled by a curved (retroflexed) camera 44 inside the abdominal cavity. This implanting maneuver should be repeated - by following the full rotation of the laparo-endoscopic system within the wound 40 - to implant the locking elements 84 into the wound edges 40 around its whole circumference (Fig. 28). Then the laparo-endoscopic system is pulled back and removed from the patient, while the implanting tube 85 is dislodged from the laparo-endoscopic system by the help of the sliding connection 29 and remains in place. As a consequence, the locking elements 84 within the wound edges 40, the threads 23 and the tube 85 containing the threads 23 remain inside the stomach 39. By simultaneously lifting the threads upward and by pushing the implanting tube 85 downward, the edges of the wound 40 are pulled up into the inner end of the implanting tube (Fig. 29/C). The outer end of the implanting tube 85 is introduced between the stapling surfaces 93 and the control thread 91 of the stapler 88, and then the stapler 88 is pushed down along the implanting tube 85 to the wound 40 trough the mouth (Fig. 30). Advantageously the stapler 88 has a camera 44.
In order to achieve better control over the process the endoscopic stapler 88 is bent at the articulation 4. After the control thread 91 is slightly tensioned the stomach 39 wound 40 is pulled between the opened stapling surfaces 93 and the control thread 91. After the adjustable jaw 95 is closed while the control thread 91 is continuously tensioned, the situation is checked again with the camera 44. Then the stapler 88 is fired and the wound 40 is closed and the stapled wound 94 is checked with the camera 44. This procedure could be performed with different type of staplers (Fig. 31, 32 and 33).
The most important advantages of the solutions according to this invention as claimed shall be that they ensure to reliably accomplish all steps (access, surgical intervention, closure) of NOTES (Natural Orifice Transluminal Endoscopic Surgery), SPLS (Single Port Laparoscopic Surgery) and IE (Interventional Endoscopy) procedures through the natural orifices, similarly to the reliable and well developed laparoscopic techniques and maneuvers.
Device for surgical interventions, comprising (i) an inner end guidable/steerable to the operation field, (ii) an outer end (3) operated by the user and (iii) a middle part (2) which connects both ends (1, 3) together it comprises force transmission units extending between the outer (3) and the inner (1) ends, and said force transmission units, the outer and the inner ends and the middle part (2) are designed to transfer the movements of the outer end (3) to the inner end (1) in an identical measure, as if the inner end (1) were the straight continuation of the outer end (3), characterized in that it comprises (i) a first force transmission unit that is able to transfer the bending movements of the outer end (3) to the inner end (1) relative to the middle part (2) in the same rotational angle and in the same rotational direction, and (ii) a second force transmission unit that is able to transfer the axial telescopic movements of the outer end (3) to the inner end (1) with the same extent but in the opposite direction.
Surgical device according to claim 1 characterized in that there are articulations (4) between the outer end (3) and the middle part (2) and between the inner end (1) and the middle part (2), and the first force transmission unit (12) is designed to transfer the movements of the first articulation (4) to the second articulation (4) and the movements of the second articulation (4) to the first articulation (4).
Surgical device according to claims 1 or 2 characterized in that the first force transmission unit (12) comprises at least one pair of antagonistic wires (5) extending from the inner end (1) throughout the articulations (4) and the middle part (2) to the outer end (3) opposite to one another or the first force transmission unit (12) comprises at least one flexible or rigid pusher rod extending from the inner end (1) throughout the articulations (4) and the middle part (2) to the outer end (3).
Surgical device according to any of claims 1 to 3 characterized in that the outer end (3) and the inner end (1) is telescopic, and the second force transmission unit is designed to elongate the telescopic inner end (1) when the outer end (3) is compressed, and to contract the telescopic inner end (1) when the telescopic outer end (3) is elongated.
Surgical device according to claim 4 characterized in that it has a channel inside, and the second force transmission unit comprises force transmission particles (12) - advantageously balls - connected to each other, and said particles (12) fill in the whole length of the channel, and each of them have a hole, and through these holes of the particles (12) travels the motive wire (13); or the second force transmission unit is a sealed hydraulic unit (14) located inside the channel, which has an outer part (17) inside the outer end (3) and an inner part (16) inside the inner end (1) advantageously with accordion-like folding structures, designed to be elongated or compressed along their longitudinal axis; or the second force transmission unit is a slidable flexible sheath (108) which is designed to resist compression along the longitudinal axis and to resist torsion around the longitudinal axis.
Surgical device according to any of claims 1 to 5 characterized in that the outer end (3), the inner end (1) and the middle part (2) are the components of a surgical instrument (6), and said instrument (6) is located within a rigid or flexible trocar sleeve (7).
Surgical device according to any of claims 1 to 5 characterized in that the outer end (3), the inner end (1) and the middle part (2) are the components of a trocar sleeve (7), and said trocar sleeve (7) has advantageously an airtight valve (22) located at the outer end (3).
Surgical device according to claim 7 characterized in that there is a surgical instrument (6) located within the trocar sleeve (7), and said instrument (6) has an outer end (3), an inner end (1) and a flexible middle part (2).
Surgical device according to claim 8 characterized in that the first force transmission unit (12) is situated inside the trocar sleeve (7) which contains the surgical instrument (6), and the second force transmission unit is situated inside the channel of the instrument (6).
Surgical device according to claim 9 characterized in that the outer end (3) and the inner end (1) of the surgical instrument (6) is telescopic, and the second force transmission unit comprises force transmission particles (12) - advantageously balls - connected to each other, and said particles (12) fill in the whole length of the channel; or the second force transmission unit is a sealed hydraulic unit (14) situated inside the channel of the surgical instrument (6) which has an outer part (17) inside the outer end (3) and an inner part (16) inside the inner end (1) advantageously with accordion-like folding structures, designed to be elongated or compressed along their longitudinal axis; or the second force transmission unit is a slideable flexible sheath (108) inside the channel of a surgical instrument (6), which is designed to resist compression along the longitudinal axis and to resist torsion around the longitudinal axis.
Surgical device according to claims 9 or 10 characterized in that the first force transmission unit (12) is situated in the trocar sleeve (6) which contains the surgical instrument (6), and the instrument (6) - functioning as a second force transmission unit - is designed to resist compression along the longitudinal axis and to resist torsion around the longitudinal axis.
Surgical device according to any of claims 7 to 11 characterized in that it comprises more than one trocar sleeves (7) with inner ends (1), and at least two trocar sleeves (7) are arranged to determine a step-like structure at their inner ends (1).
Surgical device according to claim 12 characterized in that at least one trocar sleeve (7) comprising at least one working channel (27) therein is connected with sliding connection (29) to one or more trocar sleeves (7).
Surgical device according to any of claims 6 to 13 characterized in that it has a partially or totally flexible or rigid tube (28) comprising (i) a cylindrical body with circular or elliptic cross-section, (ii) an inner (52) and an outer (53) end, and advantageously (iii) a gas (55) and/or a suction-irrigation (63) connection, and said tube (28) is feasible to house inside one or more surgical instruments (6) and/or trocar sleeves (7), and to be fixed by the inner (1) and the outer (3) ends to the abdominal wall (41) and/or to external fixateurs (42), and preferably on the outer surface of the inner end (52) the tube (28) has (i) a thread (23) with a needle (24) and/or a stick (51) which can be passed through the abdominal wall (41) and can be fixed to an external fixateur (42), or (ii) a connecting point - advantageously formed as a groove (11) or a rail (50) - designed to connect to a control rod (61) which makes the fixation to the abdominal wall (41) possible.
Surgical device according to any of claims 6 to 13 characterized in that it has a partially or totally flexible or rigid endoscopic device (66, 103) comprising (i) a cylindrical body with circular or elliptic cross-section, (ii) more than one working channels (27), and advantageously (iii) a gas (55) and/or a suction-irrigation (63) connection, and at least one working channel (27) is designed to house inside one or more surgical instruments (6) and/or trocar sleeves (7) and preferably the outer surface of the inner end (52) the endoscopic device (66, 103) has (i) a thread (23) with a needle (24) and/or a stick (51) which can be passed through the abdominal wall (41) and can be fixed to an external fixateur (42), or (ii) a connecting point - advantageously formed as a groove (11) or a rail (50) - designed to connect to a control rod (61) which makes the fixation to the abdominal wall (41) possible, and preferably the endoscopic device (66) is designed to be partially or totally divided at least into two parts by a plane parallel with the longitudinal axis, and said divided parts are connected by sliding connections (29), and they are shiftable relative to each other or the endoscopic device (103) is non-divided, and at the inner end (52) there is an oblique (101) or step-form (100) designed opening (31).
EP10773698.5A 2009-09-02 2010-09-02 Surgical device and accessories Active EP2473119B1 (en)
EP2473119A2 EP2473119A2 (en) 2012-07-11
EP2473119B1 true EP2473119B1 (en) 2015-04-01
EP10773698.5A Active EP2473119B1 (en) 2009-09-02 2010-09-02 Surgical device and accessories
CN107736907A (en) * 2017-10-27 2018-02-27 无锡贝恩外科器械有限公司 Disposable endoscope linear cutter stapler
2009-09-02 HU HU0900538A patent/HU0900538A2/en active IP Right Revival
US20120232339A1 (en) 2012-09-13
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