"ENDOSCOPIC SUTURING APARATTUS"
The present invention refers to an endoscopic suturing device and a surgical wire lock' used for performing said suturing, providing the means to perform a quick and efficient suturing work.
STATE OF THE ART
Other endoscopic suturing devices are already known, and among these one deserving special attention is presented in WO 0189393, "Tissue capturing and suturing device and method", published on November 29, 2001; said device comprises a tubular metallic capsule, which allows the sucking to its interior of a portion of animal tissue, and execute a surgical stitch with wire; the device is coupled to the end of an endoscope, being introduced through the patient's mouth until it reaches the stomach, wherein a portion of tissue from the gastric wall is sucked inside the device; said portion of tissue is punctured by a needle with a surgical wire attached to it, performing a surgical stitch. Repetition of said procedure allows for two surgical wires , which are locked through a knot .
In general, this is a way to effect endoscopic suturing; however said procedure, executed using the above mentioned device, presents a series of limitations, revealed as both material and operational difficulties.
PURPOSE OF THE INVENTION
It is the object of the present invention to present an apparatus for the performance of endoscopic suturing providing better visibility for the work during the surgical procedure, with simplicity and efficiency, providing an effective locking of the surgical wires used in the suture. Said object is achieved by means of a transparent capsule, coupled to the endoscope end and a needle coupled to a cable and tubes that slide inside the endoscope 's internal working channel, being there also a locking device to ensure the locking of the wires and therefore of the whole suture.
BRIEF DESCRIPTION OF THE DRAWINGS
The present invention will be briefly described below based on an execution example represented in the drawings .
Said drawings exhibit:
Figure 1 - a side view of an endoscopic suturing device, belonging' to the previous state of the art;
Figure 2 - a perspective view showing a needle coupled to . a steel tube, used to perform endoscopic suturing by means of a device of the previous state of the art;
Figure 3 - a perspective ■ view of a capsule belonging to the apparatus of the present invention, decoupled from the endoscope;
Figure 4 - a perspective explanatory view of the physical disposition of a needle coupled to a surgical wire, to a cable and to two tubes, forming a set belonging to the invention, introduced in a working channel of the endoscope;
Figure 5 - a detailed enlarged view of said needle shown on Figure 4;
Figures 6 and 7 - perspective views showing the disposition of the needle coupled to the surgical wire, the cable and the two tubes, forming a set introduced in the endoscope 's internal channel ;
Figures 8 and 9 - perspective views of the capsule assembly of the present invention mounted at the end of the endoscope, along with the kit of needle, surgical wire, cable and tubes ;
Figures 10 to 14 - perspective views of the capsule of the present invention, performing an endoscopic suture;
Figures 15 and 16 - schematic views showing endoscopic sutures performed on a patient, by means of the capsule of the invention;
Figure 17 - an schematic enlarged view of the region near the patient's mouth, showing the free ends of the surgical wires, cut, used for the suturing;
Figure 18 - schematic, view illustrating a first step for the conclusion of the endoscopic suturing on the patient, by means of a knot tied with the surgical wires;
Figure 19 - schematic view exhibiting the placement of a surgical wire lock of said suturing in the patient;
Figures 20 and 21 - detailed enlarged views of the disposition of both the lock and the surgical wires shown on Figure 18;
Figure 22 - schematic view showing a second step for the conclusion of the suturing on the patient, using the lock;
Figure 23 - schematic detailed view illustrating the final conclusion of the procedure on the patient, with the closing of said lock;
Figure 24 - an enlarged detailed view of the lock illustrated on Figure 23, then completely closed.
DETAILED DESCRIPTION OF THE FIGURES AND OF THE INVENTION
Figure 1 shows an X device to perform endoscopic suturing, belonging to the previous state of the art; device X, made of metal, is coupled to the end of an endoscope E, having an fastening system made up by springs and brackets forming a mechanism Y partially articulated that rigidly fastens device X to said endoscope. Said mechanism Y must be handled with care, during the coupling of device X to the endoscope E, so that said device does not becomes loose or damage said endoscope. Furthermore, it is immediately observed that device X is shifted from endoscope E, or, in other words, that the lines of the longitudinal geometric centers, both of the device and the endoscope 's end, indicated in the Figure with a dash-dot line, are not aligned to each other, which increases the width of the apparatus (device X + endoscope E) that will pass through the patient's mouth, pharynx and esophagus, which may cause an extra discomfort sensation to the patient and complicate the introduction if compared to smaller gauged equipment . device X is hollow and features in it's body a through window J, surrounded in dashed line, serving as an entry port for the patient stomach wall tissue, which is progressively sucked inside device X to be surgically sutured. Said suction is accused by a vacuum tube Z coupled to device X; said tube Z remains loose, positioned externally from endoscope E, to which it is linked by adhesive tape. That is another element that contributes to a larger diameter of the device-endoscope set .
The endoscope features internally a working channel W, depicted with a dotted line, into which a needle A' coupled to a steel tube T' were previously introduced (thes'e are not shown in the Figure) . Once a portion of tissue is already sucked in through window J and is inside device X, the metal section A' will serve as support to the wire used in the surgical suture, being pushed by tube T', which in turn features a pointed end, until it pierces the tissue, passing through it. The tip of endoscope E features, usually, a V lens belonging to a sighting apparatus; it is observed that said V lens is positioned outside device X, which does not allow visual control of the procedure being performed on the inside of the suction capsule, rendering this particular phase of the process virtually blind.
Figure 2 is showing said needle A' coupled to the steel tube T', according to the previous state of the art; as already explained, tube T' has a rigid and pointed end, responsible for the piercing of the tissue to be sutured; said rigid part is some 3 centimeters long and is connected to the remainder of tube T', which is a fine and flexible tubular spring; the end of tubular metal section A' is forked, as shown on detail B' indicated by an encircling dashed line, and a surgical wire C is attached to tube A' , which is introduced in the hollow tube T' , which in turn presents a longitudinal groove R', surrounded in dashed line; the reason for this groove R' is to house the wire C when the needle A' is coupled to the T' . all this set comprising needle A', wire C' and tubes T', runs through the working channel W of the endoscope, with he pointed end of tube T' and tube A' being positioned inside said device X; thus, upon the placement (and withdrawal) of said set on endoscope E, extreme caution is required, lest not to damage the endoscope, as will be explained further below; the needle A' and the end of tube T' are of complex design, with the groove R' and forked area B', which renders its manufacture more laborious. It is also necessary to observe that, as he tube T' has the shape of a needle at its end dedicated to the piercing of the sucked tissue, and the rigid metal section is relatively long, it's introduction in the working channel of the endoscope can only be effected backwards. It is quite obvious that
it's withdrawal can also only be performed by the end of the endoscope, which once again demands care and attention on handling, because any orientation failure will definitely damage the endoscope .
The present invention was designed to perform a similar procedure, through the development of a device different from that of the current state of the art, simplified in some operational details . The present invention proposes a capsule for endoscopic suturing, 10, illustrated detached from the endoscope E, as exhibited on Figure 3; said capsule 10 has a circular cross- section, is made of a highly transparent material, features a first end 12 closed, rounded, and a second end 11, slanted diagonally, open; there is also a through window 14 in the body of capsule 10, being said window surrounded in a dashed line and serving as an entry port for the tissue from the patient's stomach wall, which will be sucked into capsule 10 to be surgically sutured. Inside capsule 10, between window 14 and the end 12, there is a net 13 placed transversally to the capsule walls.
Figure 4 illustrates the physical disposition of a needle 20 coupled to a surgical wire 22, a steel cable 21 and two hollow tubes 23 and 24, forming a set belonging to the invention, named suturing kit, introduced in the internal working channel W of endoscope E; the needle 20 is hollow, metallic and has the same diameter as that of tube 23, which is also metallic, hollow; a first end 27 of the needle 20 is slanted diagonally, open, and a second end 28 of the same needle is also open but is not slanted, on the contrary it is straight, being set in a plan which is parallel to the cross-section of the needle 20. In the body of needle 20 there is also a through opening 25 in which the surgical wire 22 penetrates, which follows the direction of the end 27; there is a knot 26, indicated by a surrounding dashed line, made in the portion of the wire 22 that comes out of said end 27. Inside the tube 24 is introduced tube 23, inside of which in turn is placed the cable 21, which exits through end 29 of the tube 23 and enters the needle 20 through the end 28 and passes under the opening 25, inside the needle 20, being parallel to the surgical wire 22; the detailed area D, surrounded in a dashed
line, indicates the disposition of the end of the cable 21 parallel to the wire 22, effecting a firm locking of both inside the needle 20 and near the end 27, as is 'also observed on Figure 5, in an enlarged view. The diameter of the steel cable 21 is slightly smaller that the internal diameters of both the needle 20 and the tube 23, so that the cable 21 can slide inside the tube 23 but cannot do it as freely through the needle 20, due to the aforementioned locking caused by the wire 22. It is also worth noting that, on Figure 4, that the end of the endoscope E features the lighting sources L and a suction or vacuum channel A, besides the V lens belonging to the instrument's sighting apparatus.
Figures 6 and 7 show, successively, the dispositions of the needle 20 coupled to the surgical wire 22 and to the steel cable 21, along with the two tubes 23 and 24, forming said suturing kit introduced in the internal channel W of the endoscope; firstly, according to Figure 6, with the cable 21 (indicated in a dashed line) locked to the needle 20 along with the wire 22 , the cable 21 is pulled back inside tube 23 until the end 28 of needle 20 touches the end 29 of tube 23; let us observe that the knot 26 of wire 22 is positioned inside the needle 20, close to the pointed end 27. After that, according to Figure 7, the tube 23 is pulled back along with the needle 20, the cable 21 and the surgical wire 22, back inside the tube 24, observing that the pointed end 27 of said needle 20 is positioned at a certain distance from the end of the tube 24, and through this very same end exists the surgical wire 22, which remains external to said tube 24; thus, the wire 22 runs parallel to the tube 24, both of them introduced in the working channel W of the endoscope E.
The mounting of the suture kit to the endoscope is quick and simple, because the steel cable 21 is inside the metal tube 23, and both, along with the needle 20, remain completely embedded inside the tube 24; furthermore, said tube 24 is made of a material which is dense but flexible, plastic, not causing damage to the endoscope, and therefore the introduction of the suturing kit into channel W of the instrument does not demand any special technique or procedure; the same is valid for the
reverse operation, in other words the disassembly or removal of said suturing kit.
Figures " 8 and 9 illustrate the coupling "of the' capsule 10 of- the present invention to the end of endoscope E, with said suturing kit placed inside the working channel W'. the end of the endoscope E is introduced in the slanted diagonally end 11 of capsule 10, and the diameter of said end 11 is equal or slightly smaller than the diameter of the end of the endoscope E, so that there is a firm and safe fit between the endoscope and said capsule. Optionally, the inner region near the end 11 of the capsule 10 is shriveled, so as to provide an even tighter coupling to the endoscope E. it is observed that the suturing kit, the lighting sources L, the suction channel A and the V lens of the endoscope lie inside the capsule 10.
Figure 10 depicts a situation where the capsule of the present invention is performing a endoscopic suture; a portion of tissue K was sucked through the window 14 inside the capsule 10. The suction channel A of endoscope E was used to effect said tissue suction. As the V lens of the sighting apparatus of the endoscope lies inside the capsule 10, the professional performing the endoscopic suture enjoys an optimal vision of everything that happens inside capsule 10, being able to see clearly all the surgical procedure happening to tissue K; furthermore, as capsule 10 is made of a highly transparent material, the professional can also see, through the V lens, the external region, around the capsule 10, aided by the lighting provided by the lighting sources L, equally placed inside the capsule 10. That represents one of the fundamental differences regarding the previous art devices, with advantageous aspects, because the V lens of the endoscope is positioned outside the suturing device described in the state of the art, making impossible a view of what is going on with the sucked tissue, which is being sutured inside said device and, furthermore, the very body of the device obstructs the viewing, through the V lens, of a considerable part of the region around the same device.
Figures 11 a 14 show in successive steps the further development of the endoscopic suturing, by means of the
capsule 10; in Figure 11, the tube 23 along with the cable 21, inside the tube 23, were pushed outside of the tube 24, towards the portion of tissue K; the tube 23 pushes the needle 20, where the pointed end 27 pierces the tissue causing the penetration of said needle into it, along with the surgical wire 22 and the tube 23 itself, carrying the cable 21 inside of it.
Figure 12 illustrates a situation where the tube
23, along with cable 21, proceeds to push the needle 20 through the tissue K until it leaves said tissue, passing through the net 13 of which interstices or spacing between the wires that make it up present physical dimensions sufficiently large to allow the passage of said needle 20. It should be pointed out that the needle 20 is positioned near the rounded end 12 of the capsule 10, with the ends 28 of the needle and 29 of the tube 23 touching the rail 13.
Figure 13 depicts a situation where the steel cable 21 was tensioned, withdrawn to the inside of the tube 23; the tube 23 is still set inside the portion of tissue K; and the needle 20 is at the front portion of the tube 23, with the ends 28, 29 touching, the tube 23 serves as a baffle plate for the needle 20, which is free in the space between the rail 13 and the rounded end 12 of the capsule 10, attached only by the surgical wire 22; the wire 22 remains attached to the needle 20, due to the existence of the knot 26 (not shown in the Figure) positioned inside the needle 20, near the pointed end 27.
In Figure 14 there is the finalization of the endoscopic suture performed with the capsule 10, where the steel cable 21 has already been withdrawn inside the tube 23, this also exiting the portion of tissue K, being withdrawn inside the tube
24, with the needle 20 still leaned on the rail 13 and the surgical wire 22 remaining passed through the tissue K; said portion of tissue K was ejected from capsule 10 through window 14, simply reversing the action of the suction channel A of endoscope E, which instead of sucking starts to blow air inside the capsule 10, ejecting the tissue K of capsule 10. As already mentioned, every suture operation is clearly viewed by the professional who is performing the surgical procedure, through the endoscope,
because the V lens is situated inside capsule 10; the professional handles the tube 23 and the cable 21, evidently, by the other end of the endoscope E, which lies outside the patient's body.
Figure 15 illustrates schematically an endoscopic suture performed in a hollow organ, such as a stomach, by means of the capsule of the present invention; the capsule 10, along with the endoscope E, was withdrawn through the patient's mouth, keeping the surgical wire 22 passed through the portion of tissue K; Figure 16 illustrates schematically another endoscopic suture in the same patient, performed on a portion of tissue K' using a surgical wire 22', using the same capsule 10. The wire 22 of the first suture, on tissue K, was cut near the patient's mouth, and it's free ends; and later on the wire 22' of the second suture, this one on tissue K', will be cut near the patient's mouth, the ends also remaining free.
The preparation of capsule 10 between one endoscopic suture operation and the next is quite simple; given the point in the gastric wall and once tensioned the surgical wire to the patient's mouth by traction of the endoscope, the needle 20 gets fixed onto the rail 13. When the capsule 10 exits through the mouth, the wire is cut and the needle 20 is withdrawn through the rail, being the needle discarded.
After that the capsule 10 is detached from the endoscope E, the remains of the previously used suturing kit (surgical wire, tubes 23, 24 and steel cable 21) are withdrawn from inside the working channel W, and a new, complete suturing kit is placed into the same channel W, with new tubes 23, 24, cable 21 and a new needle 20, already coupled to a new surgical wire, being everything sterilized; the capsule 10 is coupled back to the end of endoscope E, and thus one more endoscopic suturing operation may be performed.
Figure 17 is a schematic, enlarged view of the region near the patient's mouth, showing the free ends of the surgical wires, cut, used in the suturing; the free ends P and Q belonging to the wire 22, and the ends P' and Q' belonging to the wire 22 ' ; the wires 22 and 22 ' are united through the ends P and P', which are brought together by means of a knot. Later, the ends
Q and Q' are pulled so that the wires 22, 22' slip and the knot that unites the ends P, P' goes down through the proximal digestive tube of the patient, reaching the place bf suturing of the tissues K and K' .
Figure 18 illustrates schematically the patient having his/her sutured portions of tissue K and K' united, by means of the union of the surgical wires 22 and 22 ' through said knot, indicated by the reference numeral 50, tied at the ends P, P' of said surgical wires; near the patient's mouth, and the ends Q and Q' of the same wires remain free.
Figure 19 represents in a schematic manner the placement of a lock 33 on the ends Q, Q' of the surgical wires 22, 22' of said endoscopic sutures performed on the patient; the lock is surrounded in a dashed line, indicating a detailed view, shown enlarged on Figure 20. According to Figure 20, it is possible to observe that said lock 33 is formed by a male component 41, formed by a conical section body with a small through hole 44, to which is fastened by means of knots, for example, a flexible cable 42, and a female component 40 made up by a hollow conical section body, which internal physical dimensions coincide with the physical dimensions of part 41; the body of part 40 has through holes 43, which are the holes through which the ends Q and Q' of the surgical wires 22, 22' are introduced, penetrating one side of part 40, crossing it perpendicularly and exiting on the other side of the same part. The cable 42, in its turn, passes longitudinally through part 40.
Figure 21 depicts a sequence of Figure 20, where a male component 41 was partially introduced into the female component 40, only to keep said part 41 positioned in a way to facilitate the late, definitive closing of lock 33; it is worth observing that part 41 does not touch the ends Q, Q' of the wires 22, 22' .
Figures 22 and 23 exhibit, in an enlarged view if compared to the schematic views represented on Figures 15 a 19, the final conclusion of the endoscopic sutures on the patient, using the lock 33; Figure 22 represents a situation where, with the ends Q, Q' of the surgical wires 22, 22' kept out of the
patient's mouth, the lock 33 was slid, along with the flexible cable 42, through the mouth, pharynx and esophagus of the patient, with the wires 22, 22' passing through the holes 43 in the body of part 4 female 40, and with a male component 41 partially introduced in part 40; the lock 33 was slid until it got very close to the sutured tissue K, K' portions, being kept there, for example, by means of endoscopic tweezers that hold said lock. The ends Q, Q' of the wires 22, 22' are then pulled further through the patient's mouth, while lock 33 is kept as close as possible to the tissue K, K' portions, in order to tighten up the stitch of the two endoscopic sutures therein performed which, therefore and thanks to the knot 50 and the lock 33, become one single surgical stitch; Figure 23 shows a situation where said surgical stitch is already well tightened, due to the locking exerted by the lock 33 over the wires 22, 22', which are firmly strung; the cable 42 was pulled through the patient's mouth, also pulling along a male component 41, which penetrated even further the female component 40, causing the definitive closure of the lock 33.
Figure 24 illustrates in an enlarged detail the lock 33 shown on Figure 23, then completely closed; the male component 41 is for all purposes fully introduced in the female component 40, firmly pressing the surgical wires 22, 22' against the internal walls of part 40. The excess wires 22, 22' that ended up free, outside of lock 33, as well as the flexible cable 42, are now cut, using endoscopic scissors, thus finishing the surgical intervention that presents the appearance depicted on Figure 23.
Once a preferential incorporation example is described, it must be understood that the scope of the present invention covers other possible variations, being limited only by the contents of the attached claims, including the possible equivalents .