ES2403026B1 - Occlusion and fixation system around trocar laparoscopy - Google Patents

Abstract

An occlusion and fixation system (10, 40) of a trocar for laparoscopic surgery, comprising a thread (11, 41) and a fixation device (12, 22, 42) which in turn comprises a perforation (26, 27 ). The fixing device (12, 22, 42) is configured so that the ends of said thread (11, 41) pass through said perforation (26, 27), and are fixed by said fixing device (12, 22, 42). The occlusion and fixation system (10, 40) is configured for, during use, and once said thread (11, 41) has served as a suture of a body cavity around a trocar (30): hook one of the ends of the thread (11, 41) at least one anchor point (31) of said trocar (30), so that by pulling the two ends of the thread (11, 41) to effect the suture closure, the Trocar (30) is immobilized by said suture, tightly compressing the body tissue, and fixing the two ends of the thread (11, 41) by said fixation device (12, 22, 42).

Description

OCLUSION AND FIXING SYSTEM AROUND LAPAROSCOPY TROCAR

FIELD OF THE INVENTION

The present invention belongs to the field of medical and surgical devices and, more specifically, to the occlusion systems around the laparoscopic trocar, preferably open, and fixing it to the wall of a body cavity, such as the abdominal wall.

BACKGROUND OF THE INVENTION

Today, the use in surgery of endoscopic techniques in general, and laparoscopic in particular, is very common and its advantages are universally recognized. There are many endoscopic instruments that allow the surgeon to complete his task by making minimal incisions in the skin and in the surrounding tissue to a detained body cavity. To insert the endoscopic instruments inside the body, it is necessary to perform a puncture and access the body cavity through a trocar. The trocars are widely known and are usually formed by an external sheath, which is ultimately the one that remains attached to the body wall to allow access, through it, of the surgical instruments, and an internal element, usually stabbing, which is the one that allows the group to make its way through the different layers of tissue that separate the body cavity from the outside.

Conventional trocar shutters are normally formed by toroidal inflatable chambers, or balloons, that surround the outer sheath of the trocar on the outside and inside of the access wound to the cavity (for example abdominal). An example of this is shown in British patent application GB2275420A. which describes a medical-surgical system for bladder surgery. The device is formed by a sealing member that penetrates the bladder, and a catheter through the

which the sealing member can be opened to allow urine to drain from the bladder. Among other elements, the sealing member includes one or two balloons as elements of henneticity, intended to retain the sealing member in the bladder.

In open laparoscopy, using, for example, the Hasson technique, after making an incision above or below the navel, it is observed that there are no adhesions to the access area of abdominal structures that could be injured (e.g., intestinal handles ), and then, under visual control, the trocar is introduced, which has the particular characteristic that its internal element has a blunt tip, which, together with the aforementioned visual control, minimizes the possibility of injury. Only then, after fixing the outer sheath, the internal element of the trocar is removed, and the abdominal cavity is insufflated with carbon dioxide, to then be able to insert the chyluric instruments. This technique is much safer than closed laparoscopy, in which the sequence of maneuvers is exactly the reverse: first, the abdominal cavity is punctured blindly with a thick gauge needle (Veress needle), which has mechanisms safety that does not always prevent the injury of intestinal handles or blood vessels; through said needle, the abdominal cavity is insufflated with carbon dioxide, and when it is considered sufficiently bulged, again blindly, a thick gauge trocar is introduced through the incision of the Veress needle conveniently enlarged , whose internal element is sharp, to penetrate the passage through the abdominal covers. This is the second step of the procedure in which there is a high risk of injury to internal structures, when carried out, as mentioned, totally blind. It is evident, for all that has been said, that open laparoscopy has great advantages, in terms of safety, compared to closed laparoscopy. Its only drawback is that the initial incision, through which the blunt trocar described above is introduced, is necessarily greater than that used in closed laparoscopy, which has two consequences: insufficient tightness around the trocar sheath, with the consequent loss of pneumoperitoneum, and difficulties in attaching the trocar to the abdominal wall, with unwanted mobilization of it during subsequent surgical maneuvers.

Here are some known proposals for obturation for endoscopic surgery:

US patent application US5366478A describes a sealing device for endoscopic surgical procedures consisting of two inflatable segments with toroidal fOlTIl3, positioned inside and outside the abdominal cavity respectively. The fixation and tightness that are obtained are good, but the inflatable elements occupy space, which sometimes makes the surgery itself difficult, and with some frequency they deflate or even break during the same, which forces to replace the sheath, or which is the same, to restart the entire process of access to the abdominal cavity, with the consequent loss of time and expense added.

In turn, US patent application US5848992 presents an access device for maintaining a hermetic seal in an anatomical cavity when a surgical instrument has been inserted into the cavity. This device is designed to work without trocar or other support elements, through a conventional but small incision.

On the other hand, the international patent application W095 / 24864 refers to a medical device that forms an extension of the pneumoperitoneum, allowing the surgeon greater Hexibility in surgical procedures. The device is formed by a coating and an elastically deformable ring, located at the end open to the coating. This device is actually part of a new laparoscopic approach system through a single incision, which requires the use of specific instruments and the making of an incision that is much larger than that of conventional laparoscopy.

In turn, European patent application EPI774918AI describes a device for accessing a body cavity without substantial loss of the inflatable gas introduced to the patient. The device has an extensible support that allows hennetic closure to the patient's body. This support comprises a cavity with a circular surface that adheres to the patient's body by means of a valve inserted in the cavity itself or coupled to it. However, the fixation to the body that is achieved with this extensible support is not always adequate and can

5 involve sealing problems.

SUMMARY OF THE INVENTION

The present invention seeks to solve the aforementioned drawbacks 10 by means of a trocar occlusion and fixation system for laparoscopic surgery.

Specifically, in a first aspect of the present invention, an occlusion and fixation system of a trocar for laparoscopic surgery comprising a thread and a fixation device is provided. This in turn comprises a perforation. The fixing device is configured so that the ends of the wire pass through the perforation and are fixed by the fixing device. The occlusion and fixation system is configured to, during use, and once the thread has served as a suture of a body cavity around a trocar: hook one of the ends of the hi lo at at least one anchor point of the trocar , so that when you pull the two

20 ends of the thread to effect the closure of the suture, the trocar is immobilized by the suture, compressing the body tissue with hennetic fonna, and fixing the two ends of the thread by means of the fixation device.

In a possible embodiment, the fixing device comprises a first piece and

2 5 a second piece, where one of the pieces has a spring attached, where each of the first and second pieces have a respective perforation that crosses them. The second piece is configured so that, by exerting pressure on the first piece, at least part of the first piece and the spring are housed inside the second piece until the perforations coincide, so that it can pass the

30 thread through them and the thread is immobilized by interrupting said pressure.

In that case, the spring may also be attached to the second piece or it may have a

stop configured to prevent the first and second pieces from separating completely

when there is no pressure on them.

5 Preferably the thread is braided.

Optionally, the occlusion and fixation system comprises an intent piece

configured to enter a distance between the closing point of the surura, that is,

the outward exit of both ends of the wire and the fixing device. The

The piece is preferably made of a surgical material or a material chosen from the following list of materials: glass, methacrylate, a synthetic material, a metal for surgical use and mixtures thereof.

The advantages of the invention will become apparent in the following description.

BRIEF DESCRIPTION OF THE FIGURES

In order to help a better understanding of the features of the invention, according to a preferred example of practical realization thereof, and to

20 complementing this description is accompanied as an integral part of it, a set of drawings, whose character is illustrative and not limiting. In these drawings:

The figure] shows a diagram of an occlusion and fixation system according to a possible embodiment of the invention.

Figures 2A, 28 Y2C show diagrams of the fixing device according to a possible embodiment of the invention.

Figure 3 illustrates a scheme of a conventional trocar once introduced into a polar cavity.

Figure 4 shows a schematic of an occlusion and fixation system according to an alternative embodiment of the invention.

5 Figures 5 and 6 show two photographs illustrating the use of the system of the invention to help understand it.

DETAILED DESCRIPTION OF THE INVENTION

10 In this text, the term "understands" and its variants should not be understood in an exclusive sense, that is, these terms are not intended to exclude other technical characteristics. additives, components or steps.

In addition, the "approximately", "substantially", "around", "ones", etc. they should be understood as indicating values close to which these terms accompany, since due to calculation or measurement errors, it is impossible to achieve those values with total accuracy.

The following preferred embodiments are provided by way of illustration, and are not intended to be limiting of the present invention. In addition, the present invention covers all possible combinations of particular and preferred embodiments indicated herein. For those skilled in the art, other objects, advantages and features of the invention will be derived partly from the description and partly from the practice of the

Invention

Figure 1 shows a diagram of a possible embodiment of the device object of the invention, which is a reversible system of occlusion and fixation around laparoscopy trocar, preferably open. As can be seen in the scheme of

Figure 1, the system 10 comprises a wire II and a fixing device 12.

Figures 2A, 2B Y2e illustrate a possible embodiment of the fixing device 12,

which in these figures 2A-2e is referred to as 22. The fixing device 22 of this embodiment is formed by two pieces 23 24. One of the pieces 23 has a spring 25 connected by one of its ends. This piece 23 acts as an internal plunger. The other piece or outer sheath 24 is hollow, so that it can receive inside the spring 25 or a part thereof and a part of the other piece 23 (or even all of it), which therefore must be smaller than the previous 24. The two pieces 23 24 must have a similar shape. For example, the pieces may have a cylindrical shape. In that case, the section (in this case, the diameter) of the piece 23 that has the spring 25 attached must be smaller than the section (diameter) of the piece 24 into which the smaller piece 23 and the spring 25. The pieces may have other photmas (elliptical section, square, or in any other way).

The pieces 23 24 each have a perforation, hole or hole 26 27 that passes through them, that is, which crosses the volume that defines each piece. These two holes or perforations 26 27 are substantially the same, so that when the piece 23 and the spring 25 are inserted into the cavity of the other piece 24, the two holes 26 27 coincide.

Figure 2A shows the elements that form the device 22 in total relaxation, that is, when no pressure is exerted to introduce the piece 23 with the spring 25 into the part of greater section 24. Figure 2B shows the device 22 when It is exerting a pressure to introduce a piece 23 into the other 24, that is, when pressure is being exerted to compress the inner plunger. Normally this pressure is exerted with the fingers of one hand, for example, with the thumb the piece 23 is pressed towards the piece 24 and with the index finger the piece 24 is pressed towards the piece 23, or vice versa. Figure 2e shows how the device 22 looks when the piece of smaller section 23 (internal plunger) and the spring 25 have been inserted as far as possible into the cavity of the piece of larger section 24 (external sheath), until facing or making the two perforations or openings coincide totally or substantially completely 26 27. It is in this position reflected in Figure 2e that the threads 11 can be introduced, in this case, by ceasing to exert pressure on

pieces 23 24, the occlusion system is fixed, as Figure 2B also illustrates, immobilizing the threads 11.

In a possible embodiment, the spring 25 is also attached to the larger section piece

5 24, but this union does not prevent it from being handled as explained in accordance with Figures 2A-Ze. In another possible embodiment, the spring 25 is not attached to the larger section piece 24 but it has a stop which prevents the spring 25 from coming out, disengaging the two pieces 23 24 when no pressure is exerted on them. That is, the stop (not illustrated in the figures) is intended as the two pieces 2324 that form the

10 device 22 do not separate at all, so that they are not lost or completely unlinked.

When the fixation device 12 22 is in the position described in Figure 2C, one end of the thread 11 of the occlusion and fixation system 10 is passed through the 15 holes 26 27 of the device 12 22, and when it ceases to exert pressure on the two pieces 23 24 (when the piston is released) the thread 11 is held by the fixing device 12 22 (as illustrated in Figure 2B) due to the pressure of the spring 25 that pushes the piston outwards, by compression of the thread 1I against the edge of the outer sheath (larger section piece 24). By means of new compression of the internal piston, said fixation can be unlocked at any time. The thread 11 can be both mono filament and other. The suture thread used may be of different types or thicknesses depending on the cavity accessed and the surgeon's preferences in each case. Preferably, a twisted threads with the greatest thickness possible are used to increase the friction between the device 12 22 and the same

2 5 thread 11 and in this way, ensure the fastening of the closure.

The occlusion and fixation system 10 20 works as follows: before introducing the trocar into the body cavity (for example and usually, the abdominal cavity) under direct vision of the interior thereof, a circular suture is made, of the 30 named in surgery "in a tobacco bag", in an intentional layer of resistant body tissue (which in the case of the abdominal cavity is the fascial tissue layer, which is the

more resistant), and covering the entire circumference of the incision. This suture is done

with thread 11, before or after one of its ends has been introduced and fixed

in the fixing device 12 22. This suture, once the trocar has been inserted into the

Cavity, hug it.

5

Figure 3 illustrates a scheme of a trocar 30 once inserted into a cavity

bodily. Trocar 30 is not an object of the present invention and is a conventional trocar.

Conventional trocars have an anchor point 31 on the outside for

its discretionary use by the surgeon or healthcare personnel in general. How

the

can be seen in the diagram, a part of the trocar (tubular part 32) is introduced into

the body cavity, crossing the different layers of the body: skin 33, fascia 34 and

the peritoneum 35.

The cavity is closed and the trocar is fixed as follows: One of the loops or ends of the

fifteen

thread 11 of the surura is passed around an anchor point 31 of the outer sheath of the

trocar 30 (outer trocar panel). The effect of this is that, by pulling both ends

of the suture (thread 11) to make the closure, at the same time the trocar 30 is

pulled into the body (for example, abdomen). That is, the suture, a

Once the trocar is inserted into the cavity, hug it and compress it

twenty

body tissue (1st fascia in the case of the abdomen) against its wall throughout

its circumference, when pulling the two ends of the thread 11, just as if

insert a finger inside an open tobacco bag, and then

we will pull the ends of the thread that closes his neck. Since the outer sheath of

trocar, in the portion that penetrates the body layers (for example, abdominals), has

25

conical section, this traction towards the inside of the body cavity immobilizes the trocar

in the hole, when the diameter of the hole begins to be larger than the hole of

access.

The two ends of the thread 11 are then passed through the holes or perforations

30

26 26 of the fixing device 1222 (see figure 2C). As said

before, one of the two ends of the thread 11 could have been passed before the

making the suture, since the fixation device 12 22 can be hung from the other end, without making it difficult to suture.

Once the second end of the thread ti has passed through the holes, when the piston is released (when the pressure between the two pieces 23 24 is not applied), the spring pressure 25 that pushes the piston outwards (smaller part section 23) fix the ends of the circular suture in the desired position, by compression of the two ends of the thread 11 against the edge of the hole of the outer part 24. In this way, the occlusion and fixation system 1020 is closed by hugging the trocar and leaving between the two ends of the thread II the suture of the body wall.

As explained before, by means of compression of the internal piston, said fixation can be unlocked at any time, without the need to cut the threads or undo knots, either to increase the compression by pulling the threads harder, or to reverse it completely, as is the case when the intervention ends. That is, the system is completely reversible.

This has the advantage, added to the tightness of the closure, that there is no risk that the trocar will be accidentally pulled out during surgical maneuvers, which is often the case with the conventional fixation technique, and thus the pneumoperitoneum tightness is lost. The elegant and the great advantage of the proposed system is that both effects, obtaining a hermetic closure and secure fixation of the trocar in the laparoscopic incision, are obtained by a single traction maneuver on the threads of the circular suture, and its fixation, of reversible mode, by means of the proposed closing device.

Figure 4 shows another possible embodiment of the invention. In this figure an occlusion and fixation system 40 is schematized in which, with respect to the system 10 of Figure 1, an intermediate piece 48 is added. This intermediate piece 48 is intended to prevent that, in very obese patients (a) s, the reversible locking device 12 22, is difficult to handle within the thickness of the grease layer. The intermediate piece 48 may be, by way of example, an oval ball or element. This intermediate piece 48 introduces a distance between the closing point of the suture (the outward exit of both ends of the thread 11) and the action point of the fixing device 1222,10 which makes it more comfortable to handle.

5 Preferably the piece 48 has to be made of quilurgical material, for example titanium, for subsequent sterilization and recycling, and can be of various sizes, for different degrees of obesity. Other alternative materials can be: glass, methacrylate ~ and in general, any autoclavable material. In case you want to use

10 disposable devices, any synthetic material of those usually used in surgery for said type of material can be used.

This system has been successfully tested in the operating room in abdominal open laparoscopic surgery: The tightness obtained, as well as the fixation of the trocar to the hole at the entrance to the abdomen have been significantly more satisfactory in all cases than those previously obtained with the conventional technique. The reversibility of the fixation has allowed to adjust it to the surgeon's demand during the intervention with the minimum maneuvers described above, which also contrasts favorably with the cumbersomeness of trying the intraoperative adjustment after fixation through the system

20 traditional. Finally, at the end of the procedure, the abdominal cavity is occluded definitively by knotting together both ends of the circular compression suture described above, without the need for additional stitches, necessary with the conventional fixation technique, with the consequent time gain and comfort.

Figures 5 and 6 show photographs that illustrate the use of the system of the invention. It is intended with these figures that the reader see a practical example of practicing the invention. Figure 5 shows a trocar inserted into the abdominal cavity of a patient. It is observed how the thread, once the fascia suture is made, is hooked at an anchor point of the trocar. Figure 6 shows how the two ends of the thread are fixed with the fixing device.

Claims (8)

l. An occlusion and fixation system (10, 40) of a trocar for laparoscopic surgery, characterized in that it comprises a milestone (11, 41) and a fixing device (12, 22, 42) which in turn comprises a perforation (26, 27), said fixing device (12, 22, 42) being configured so that the ends of said thread (11, 41) pass through said perforation (26, 27), and are fixed by said fixing device (1 2, 22,42), And where the occlusion and fixation system (10, 40) is configured to, during use, and once said thread (11, 41) has served as a suture of a body cavity around a trocar (30):

-

hook one of the ends of the thread (11, 41) into at least one anchor point (31) of said trocar (30), so that by pulling the two ends of the thread (11, 41) to effect the closure of the suture, the trocar (30) is immobilized by said suture, compressing the body tissue in a hennically way, fixing the two ends of the thread (11, 41) by said fixation device (12, 22, 42).

2.

The occlusion and flotation system (10, 40) of claim 1, wherein said fixing device (12, 22, 42) comprises a first piece (23) and a second piece (24), wherein one of the pieces (23 ) has a spring (25) attached, where each of said first and second pieces (24, 25) have a respective perforation (26, 27) that crosses them, said second part (24) being configured so that, when exerting pressure on said first piece (23), at least part of said first piece (23) and said spring (25) are housed inside the second piece (24) until said perforations (26, 27) coincide, so that the thread (11, 41) can be passed through them (26, 27) And said thread (11, 41) is immobilized when the pressure is swung.

3.

The occlusion and fixation system (10, 40) of claim 2, wherein said spring

(25) is also attached to said second piece (24). 4. The occlusion and fixation system (10, 40) of claim 2. wherein said second piece (24) has a stop configured to prevent said first and second pieces (23, 24) from being completely separated when not exercised pressure on them.

5.

The occlusion and fixation system (40) of any of the preceding claims, wherein said thread (JI, 41) is of the twisted type.

6.

The occlusion and fixation system (40) of any of the claims

10 above, which comprises an intent piece (48) configured to introduce a distance between the suture closing point, that is, the outward exit of both ends of the thread (41) and the fixing device (42). 7. The occlusion and fixation system (10, 40) of claim 6, wherein said inteffiledia piece (48) is made of a surgical material. 8. The occlusion and fixation system (10, 40) of claim 6, wherein said piece (48) is made of a material chosen from the following list of materials: glass, methacrylate, a synthetic material, a metal for use Surgical and mixtures.