MXPA06006068A - Instrumentation for carrying out a gastrointestinal bypass - Google Patents

Abstract

An instrumentation for carrying out a gastrointestinal bypass comprises means for bringing close together a first tissue portion (12) of the intestine and second tissue portion (14) of the stomach by realising a first intestine loop (A), means for creating a gastroenteroanastomosis (16) between the two close tissue portions, for example a linear stapler, maintaining or restoring the continuity of the intestinal duct after the realisation of the gastroenteroanastomosis, means for bringing close together an additional first tissue portion (18) of the intestine, arranged distally with respect to the gastroenteroanastomosis (16) with reference to the natural flow of the food along the intestinal duct, and an additional second tissue portion (20) of the intestine arranged proximally with respect to the gastroenteroanastomosis (16) with reference to the natural flow of the food along the intestinal duct, realising a second loop (B) of the intestine, wherein said additional second tissue portion (20) of the intestine arranged proximally with respect to the gastroenteroanastomosis (16) is brought close to the gastroenteroanastomosis (16), means for creating an enteroenteroanastomosis (22) between the two close tissue portions of the intestine, maintaining or restoring the continuity of the intestinal duct after the realisation of the enteroenteroanastomosis, and means for sectioning the intestine between the gastroenteroanastomosis (16) and the enteroenteroanastomosis (22).

Description

INSTRUMENTATION AND METHOD TO CARRY OUT A GASTROINTESTINAL BYPASS DESCRIPTIVE MEMORY In general terms, present invention considers instrumentation and a method to perform a gastrointestinal bypass. Said instrumentation and method are particularly adapted to be used laparoscopically or intraluminally. . Techniques that are known to perform gastrointestinal shunts, including the gastric bypass known as "Roux-en-Y", follow the gastrointestinal course of flatulence between a stomach pouch, to which a portion of the intestine is directly connected. Consequently a large part of the stomach and intestine are derived with the creation of a gastroenteroanastomosis. This technique, however, has numerous drawbacks both in terms of high time required in the execution and in terms of risk and post-operative complications. As is known, in general, the approach, both laparoscopic and intraluminal, considerably limits the disadvantages of the conventional surgery methodology. In particular, they allow to limit the invasion of the procedure, reducing the risks for the patient and shortening the post-operative course.

The instrumentation currently available does not however allow limiting the drawbacks of the prior art and in particular the gastrointestinal bypass techniques as described above. For example, the use of circular staplers, especially in the performance of the gastroenteroanastomosis, requires large sections of the intestine, which includes its integrity and continuity even before concluding the operation. It makes the operation continue to be invasive and does not allow to verify the effectiveness and seal of the anastomosis, particularly of enteroenteroanastomosis. Other drawbacks of known techniques and instrumentation are for example tied to the preliminary section of the bowel which requires considerable experience to evaluate the correct length at which to perform the cut and recognize the two sectioned flaps. A further disadvantage is rather due to the large area of action that substantially covers the entire abdomen of the patient. The underlying problem of the present invention is that of proposing instrumentation and a method for carrying out gastrointestinal shunts that are capable of overcoming the disadvantages mentioned with reference to the prior art, and thus allow to satisfy the growing need of the field to limit the risks and invasions. Said problem is solved by means of the instrumentation to carry out a gastrointestinal bypass according to claim 1 and by means of a method to carry out a gastrointestinal bypass according to claim 16. Additional characteristics and advantages of the instrumentation and The method for carrying out gastrointestinal derivations according to the invention will be clear from the description reported below of preferred embodiments, given as indicative and non-limiting, with reference to the appended figures, wherein: Figure 1 illustrates a first step of the method to perform a gastrointestinal bypass according to an aspect of the present invention; Figure 2 illustrates a second step of the method for performing a gastrointestinal bypass according to one aspect of the present invention. Figures 3-6 illustrate various steps of the method according to a further aspect of the present invention and in particular Figure 5a. Illustrates an enlarged detail of Figure 5 according to a possible embodiment and from a different angle. Figure 7 illustrates a possible variation of the embodiment of Figure 4. According to a possible embodiment, the present invention considers a method for carrying out a gastrointestinal bypass comprising the steps as illustrated in Figures 1 and 2.

Said method comprises steps to approximate and unite the tissues to form anastomoses adapted to maintain or restore the integrity and continuity of the intestinal tract after each anastomotic formation (either gastroenteroanastomosis or enteroenteroanastomosis). Even more, the gastroenteroanastomosis and the enteroenteroanastomosis are performed at close distance, to balance the needs of contrast to limit the area of operation, for example, to only an upper area of the abdomen, while maintaining a wide visual and operating area. According to a possible modality, a first step of the method envisages making a gastric pouch 100 to which the first portion of the intestine will be connected. Subsequently, a loop of the intestine is selected to join the gastric pouch. The decision is made by measuring the available length and possibly verifying that no tensions or distortions are generated. A first portion of the tissue 12 of the intestine, which corresponds to the chosen loop, therefore approaches the second portion of the tissue 14 of the stomach in the gastric bag 100. In this way, a first loop A of the intestine is made. extends between the stomach and the first portion of tissue 12 of the intestine. To the two portions of tissue a slight incision is made to form an enterotomy and a gastrotomy to allow the insertion of the respective jaw of the linear stapler. A jaw of the linear stapler is inserted into the gastrotomy performed on the second portion of the stomach tissue. The other jaw of the linear stapler is inserted into the enterotomy made in the first portion of the intestine tissue. A flap of the two incisions is then sutured with a linear stapler by means of a sequence of stitches, joining the two tissue portions and partially defining the gastroenteroanastomosis. According to a preferred embodiment, the gastrotomy and enterotomy is performed before the two tissue portions are approximated. In this case, the linear stapler is used as an instrument to approximate the two tissue portions, for example, by inserting one of the two jaws of the linear stapler into the enterotomy and using the stapler to approximate the first portion of the tissue with the second portion. of the tissue. The other jaw is then inserted into the gastrotomy to join the two tissues. To complete the anastomosis (gastroenteroanastomosis 16) between the two tissue portions, the flaps of the gastrotomy and enterotomy are closed again, for example by means of suture. This allows to restore the continuity of the intestinal tract after performing the gastroenteroanastomosis. Certainly, after having completed the gastroenteroanastomosis, the intestinal tract maintains its integrity and continuity, since the incisions made were re-stapled to form the gastroenteroanastomosis. According to a preferred embodiment, the step where the gastroenteroanastomosis 16 is completed, is performed substantially at the end of the procedure, before severing the intestine and before carrying out the sealing test, as will be described below. Subsequently, an additional loop of the distal bowel is chosen with respect to the gastroenteroanastomosis in reference to the natural flow along the intestinal tract, ie, to the flow before carrying out the gastrointestinal bypass. In other words, a distal flow handle of the gastroenteroanastomosis 16 is intended to be distal by reference to the natural flow along the intestinal tract. The definition of proximal or distal will also be used later with reference to the natural flow within the intestinal tract. A first additional tissue portion corresponding to the additional bowel handle, distal to the gastroenteroanastomosis 16 with reference to natural flow along the intestinal tract, is then approached to a second portion of the additional tissue 20 of the intestine, proximal to to the natural flow of the intestinal tract, making a second B loop of the intestine which is distal with respect to the gastroenteroanastomosis. In other words, as defined above, the first portion of additional tissue 18 is placed in a downstream stream of gastroenteroanastomosis 16 with respect to the natural flow along the intestinal tract, moreover the second portion of the tissue 20 is placed upstream of the gastroenteroanastomosis 16 with respect to the flow natural of the intestinal tract.

The second portion of the additional tissue of the intestine, proximally placed with respect to the gastroenteroanastomosis 16, approaches the gastroenteroanastomosis. In each of the additional tissue portions 18, 20, an incision (enterotomy) is made, adapted to receive a respective jaw of the linear stapler. A first jaw of the linear stapler is inserted into the enterotomy made in the first portion of the intestine tissue. A second jaw of the linear stapler is inserted into the enterotomy made in the second portion of the additional tissue of the intestine. A sequence of points is then applied, which partially binds the flaps of the enterotomy and partially defines the enteroenteroanastomosis. According to a preferred embodiment described above, enterotomies are performed before the two tissue portions are approximated. In this case, the linear stapler is used as an instrument to approximate the two tissue portions, for example, by inserting one of the two jaws of the linear stapler into the enterotomy made in the first portion of the additional distal tissue, and using the stapler to approximate the first portion of the distal tissue to the second portion of the proximal tissue. The other jaw is then inserted into the enterotomy of the second portion of the proximal tissue to thus unite the two tissues. The enteroenteroanastomosis 22 between the two tissue portions is subsequently completed by closing the flaps of the enterotomies to restore continuity of the intestinal tract after the completion of the enteroenteroanastomosis. The remaining flaps of enterotomies are joined, for example, by means of sutures. According to a preferred embodiment, the step where the enteroenteroanastomosis 22 is completed, is performed substantially at the end of the procedure, at the same time that the gastroenteroanastomosis is completed before the intestine is sectioned and before carrying out the sealing test, as will describe later. After completing the enteroenteroanastomosis, the intestinal tract maintains its integrity and continuity since the incisions that were made were re-stapled to form the enteroenteroanastomosis. As illustrated in Figure 2, the gastroenteroanastomosis and the enteroenteroanastomosis are rather close together and allow to operate in the upper part of the abdomen. After making the second loop, it is possible to perform, preferably at the same time, a sealing test of the two anastomoses, for example, by means of methylene blue. The step of sectioning the intestine between the gastroenteroanastomosis and the enteroenteroanastomosis is carried out at the end of the procedure, when the proper functioning of the two anastomoses is verified. In figure 2, it is indicated with a line of section 24. Advantageously, the aforementioned method is performed with laparoscopy, comprising an initial step of inserting trocars, preferably four trocars placed respectively in the following areas: epigastrium, left flank and two trocars in the mesogastric zone. According to the present invention, the instrumentation for carrying out a gastrointestinal bypass comprises: means for bringing the first portion of the tissue 12 of the intestine to the second portion of the tissue 14 of the stomach, making a first loop A of the intestine between the stomach and the first portion of the intestine tissue, - means for creating a gastroenteroanastomosis 16 between the two portions of nearby tissue, maintaining or restoring the continuity of the intestinal tract after performing the gastroenteroanastomosis, means for approaching a first portion of the additional tissue 18 of the intestine which is positioned distally or in downstream relative to the gastroenteroanastomosis 16 with reference to the natural flow along the intestinal tract, and a second portion of the tissue 20 of the intestine placed proximally or in updraft, with respect to the natural flow along the intestinal tract, making a second B loop of the intestine which is distal with respect to the gastroenteroanastomosis 16, where said second portion of the additional tissue 20 of the intestine is placed proximally with respect to the gastroenteroanastomosis. approaches to gastroenteroanastomosis 16, - means to create an enteroenteroanastomosis 22 between the two portions of tissue near the intestine, maintaining and restoring the continuity of the intestinal tract after performing the enteroenteroanastomosis, means to section the intestine between the gastroenteroanastomosis 16 and enteroenteroanastomosis 22. Preferably, the aforementioned enteroenteroanastomosis further comprises means for carrying out the sealing test of both gastroenteroanastomosis 16 and enteroenteroanastomosis 22, before severing the intestine between gastroenteroanastomosis 16 and the enteroenteroanastomosis. 22. Even more preferably, the means for carrying out the sealing test is adapted to simultaneously test both gastroenteroanastomosis 16 and enteroenteroanastomosis 22. Said means may comprise, for example, means for inserting and visualizing methylene blue through the tract intestinal. According to a possible embodiment, the means for creating a gastroenteroanastomosis 16 comprise a linear stapler adapted to partially join the flaps of a gastrotomy and enterotomy respectively performed in the first portion of the intestine and the second portion of the stomach. The means for creating the gastroenteroanastomosis 16 further comprise means for completing the gastroenteroanastomosis by re-closing the flaps that remain open after using the linear stapler, said means being adapted to restore the continuity of the intestinal tract after performing the gastroenteroanastomosis. Preferably, the linear stapling also performs the function of means for bringing the two tissue portions together for attachment by inserting a jaw into the first portion of the tissue and using the stapler as a means for transporting the first portion of the tissue in correspondence with the second portion of the tissue. tissue. According to a possible embodiment, the means for creating the enteroenteroanastomosis comprise a linear stapler adapted to partially join the flaps of the enterotomies respectively made in the first and second portions of the additional tissue of the intestine. Moreover, the means for creating the enteroenteroanastomosis comprises means for completing the enteroenteroanastomosis by reclosing the flaps that remain open after using the linear staplers, said means being adapted to restore the continuity of the intestinal tract after performing the enteroenteroanastomosis. Preferably, the linear stapling also performs the function of means for bringing the two tissue portions together for attachment by inserting a jaw into the first portion of the tissue and using the stapler as a means for transporting the first portion of the tissue in correspondence with the second portion of the tissue. tissue. The instrumentation in accordance with the present invention advantageously comprises means for preliminarily performing a gastric pouch, wherein the second tissue portion 14 of the stomach is arranged in the gastric pouch.

Preferably, the means used are adapted to perform the gastrointestinal bypass by laparoscopy. The method and instrumentation described above can be applied both to the step of carrying out the gastroenteroanastomosis and to the step of carrying out the enteroenteroanastomosis or to one of these. Said method or instrumentation allows to reduce the risks of mortality with the gastrointestinal derivations and to limit considerably the operation times. By maintaining the continuity of the bowel until both anastomoses are completed, it is possible to verify both simultaneously. Moreover, due to the proximity of the placement of the two anastomoses, the area of operation is limited to the upper abdomen. Additionally, the advantageous provision for forming two intestinal loops without previously interrupting the continuity allows choosing the correct length in order to avoid tensions. Moreover, the performance of the gastroenteroanastomosis without preliminary sectioning of the handle allows to reduce the risk of incorrectly joining the segments or inducing undesired strains. Moreover, the combination of this method is particularly innovative, whereby the two intestinal loops are made by providing the use of linear staplers to perform the anastomosis, preferably close to one another. In fact, beyond the previously mentioned advantages, the use of linear staplers allows limiting the size and extension of bleeding, the loss and risk of stenosis. The use of the linear stapler for an application as described above overcomes a rooted disadvantage, which previously prevented this application. In particular, the advantageous provision for using a linear stapler to carry out both anastomoses in a method as described makes it possible to maintain a good perfusion of blood from the affected tissues and allows an instrument of limited size adapted to operate in a restricted area to be available. of the abdomen. According to a different modality, the steps to approach the tissues and / or create the gastroenteroanastomosis and / or enteroenteroanastomosis are performed intraluminally using an anastomotic instrument, such as, for example, the one illustrated in Figures 3-6. Said instrument is preferably made to slide along a guide, which is preliminarily inserted through the portions to be approximated and / or joined and making it part of the instrumentation according to the present invention. Preferably, the guide comprises at least one guide wire 200 placed as an open loop which traverses the portions to be joined and which can be associated with an anastomotic instrument. The partial realization of the pouch 100 in the stomach can previously provide for which first portion of the intestine will be connected. Subsequently, a first loop of open guide wire C is made through the open portion of the gastric pouch and through the first portion 12 of the intestine and the second portion 14 of the stomach that will be attached. According to a possible modality, the gastric pouch is made at the end of the procedure, after performing the gastroenteroanastomosis and the enteroenteroanastomosis. In this case, the first open loop guide wire C is made through the stomach and the intestine, crossing the portions of tissue that will be joined as for example in the illustration in figure 3. An anastomotic instrument is inserted and blocked in the guide, and is transported through means of the guide itself, until it is contiguous against the first portion 12 that will join and bring it closer to the second portion 14 to be joined. The first sequence of steps concludes with the performance of a gastroenteroanastomosis. The anastomotic instrument can be made by means of an anvil adapted to lock on the guide wire and adapted to cooperate with a circular stapler to carry out the gastroenteroanastomosis. Alternatively, the anastomotic instrument can be an instrument adapted to position an anastomotic ring, preferably elastic, to keep the two portions of tissue together (as in the example illustrated in Figure 5a with reference to the enteroenteroanastomosis) or other anastomotic instruments adapted for said purpose. Subsequently, a second open ring guide wire D is made through two portions of the intestine to be joined (a first additional portion 18, distal to the gastroenteroanastomosis and a second portion 20, proximal to the gastroenteroanastomosis). If the gastric bag is partially made at the beginning of the procedure, the second wire of the open loop guide also traverses the open portion of the gastric bag. Figure 4 illustrates the second wire of the open loop guide D without preliminary partial formation of the gastric bag. The second cable of the open loop guide passes through the gastroenteroanastomosis 16, the first additional portion 18, distal to the gastroenteroanastomosis 16 with reference to the natural flow of the intestinal tract, the second additional portion 20, proximal with respect to the gastroenteroanastomosis and has the two terminations preferably in the same hole. Figure 7 illustrates a possible variation where the wire of the open loop guide D is made by crossing the gastroenteroanastomosis 16, the first additional portion 18, distal to the gastroenteroanastomosis 16 with reference to the natural flow of the intestinal tract !, the second portion 20 additional, proximal with respect to the gastroenteroanastomosis, and has the two terminations in correspondence preferably with the same orifice. Also in this case, an anastomotic instrument is inserted and locked in the guide, and transported by means of the guide itself, until it is contiguous with the first additional portion 18 to join and bring the second additional portion 20 together to join. This second sequence of steps concludes with the completion of an enteroenteroanastomosis and the completion of the gastric pouch. As with the gastroenteroanastomosis, the anastomotic instrument can be made by means of an anvil adapted to be blocked in the guidewire and adapted to cooperate with a circular stapler to perform the enteroenteroanastomosis.

Alternatively, the anastomotic instrument may be an instrument adapted to locate an anastomotic ring 30, preferably elastic, to hold together the two tissue portions, or another anastomotic instrument adapted for that purpose. After performing the gastroenteroanastomosis and the enteroenteroanastomosis, it is possible to test both simultaneously as described above. Preferably, the step of the sealing test is carried out after performing (or completing) the gastric bag. Finally, the intestine is divided between the gastroenteroanastomosis and enteroenteroanastomosis with the section line 24. Figure 5 illustrates this last situation where also the embodiment of the gastric pouch 100 stands out at the end of the procedure. Figure 5a illustrates a detail of Figure 5 where a possible formation of the enteroenteroanastomosis is highlighted by means of a preferable elastic loop released by an anastomotic actuator instrument. The same position can possibly be adopted for gastroenteroanastomosis 16. Figure 6 illustrates a possible modality where a gastric bandage is performed. The passage of the guide through the walls of the tissues to be joined can be done by perforating the wall (for example, with radiofrequency needles) in the area intended to form the anastomosis, so that after the formation of the Anastomosis is restored the continuity of the intestinal tract.

According to a possible modality, the guide and the anastomotic instrument as already described above can be used in any technique, for example hybrid intraluminal and laparascopic or other type. According to a possible modality, the instrumentation according to this invention provides means to bring closer the portions of tissue comprising an anastomotic instrument adapted to approach and / or join the tissues intraluminally. An anastomotic instrument adapted for such purpose may be an instrument adapted to release an anastomotic ring to perform the anastomosis or a circular stapler that slides in the guide and cooperates with the lockable anvil in the guide. The instrumentation according to the present invention comprises means for partially realizing a gastric pouch before inserting the guide, where the second portion of tissue 14 of the stomach is placed in the gastric pouch, or means for realizing the complete gastric pouch at the end of the procedure. In the first case, the means are advantageously provided to complete the gastric pouch after the formation of the gastroenteroanastomosis and enteroenteroanastomosis. The method and instrumentation described above with reference to a method with the guide, preferably intraluminally, can be applied both to the step of carrying out the gastroenteroanastomosis and the step of carrying out the enteroenteroanastomosis or to one of these.

As in the previous case, the method and instrumentation foreseen allows reducing the risk of mortality in gastrointestinal diversions and considerably limiting the operation time. The maintenance and continuity in the intestine until the completion of the two anastomoses allows to verify both simultaneously. Moreover, thanks to the close arrangement of the two anastomoses, the area of operation is limited to the upper abdomen. A person skilled in the art with the purpose of satisfying specific and contingent needs, can make numerous modifications and adaptations to the preferred modalities of the instruments and methods described above, as well as substitute elements with others of functional equivalence, however without departing from the scope of the following claims.

Claims (15)

NOVELTY OF THE INVENTION CLAIMS

1. - The instrumentation for carrying out a gastrointestinal bypass comprising: means for bringing the first portion of tissue (12) of the intestine to the second portion of tissue (14) of the stomach, making a first loop (a) of the intestine between the stomach and the first tissue portion; means to create a gastroenteroanastomosis (16) between the two nearby tissue portions, maintaining or restoring the continuity of the intestinal tract after performing the gastroenteroanastomosis; means for bringing a first portion of additional tissue (18) of the intestine placed distally or in a downstream stream relative to the gastroenteroanastomosis (16) with reference to natural flow, along the intestinal tract and a second portion of additional tissue (20) of the intestine placed proximally or in ascending current, with respect to the gastroenteroanastomosis (16) with reference to the natural flow, along the intestinal tract, making a second loop (B) of the intestine, which is distal with respect to the gastroenteroanastomosis ( 16), wherein said second portion of additional tissue (20) of the intestine, proximal with respect to the gastroenteroanastomosis (16), approaches the gastroenteroanastomosis (16); means for creating an enteroenteroanastomosis (22) between the two portions of tissue near the intestine, maintaining or restoring the continuity of the intestinal tract after performing the enteroenteroanastomosis; means for sectioning the intestine between the gastroenteroanastomosis (16) and the enteroenteroanastomosis (22).

2. The instrumentation according to claim 1, further characterized in that it comprises means to carry out a sealing test both in the gastroenteroanastomosis (16) and the enteroenteroanastomosis (22), before the intestine is divided between the gastroenteroanastomosis ( 16) and the enteroenteroanastomosis (22).

3. The instrumentation according to claim 2, further characterized in that the means for carrying out a sealing test are adapted to simultaneously test both the gastroenteroanastomosis (16) and the enteroenteroanastomosis (22).

4. The instrumentation according to one of the preceding claims, further characterized in that the means for creating the gastroenteroanastomosis (16) comprises a linear stapler adapted to partially join the flaps of a gastrotomy and enterotomy, respectively, made in the first portion of the intestine and the second portion of the stomach.

5. The instrumentation according to claim 4, further characterized in that the means for creating the gastroenteroanastomosis (16) further comprise means for completing the gastroenteroanastomosis by closing, again the flaps that are still open after using the linear stapler; said means are adapted to restore the continuity of the intestinal tract after performing the gastroenteroanastomosis.

6. The instrumentation according to one of the preceding claims, further characterized in that the means for creating the enteroenteroanastomosis comprise a linear stapler adapted to partially join the enterotomy flaps, respectively, made in the first and second additional portions of the intestine.

7. The instrumentation according to claim 6, further characterized in that the means for creating the enteroenteroanastomosis further comprises means for completing the enteroenteroanastomosis by again closing the flaps that are still open, after using the linear stapler, said means are adapted to restore the continuity of the intestinal tract after performing the enteroenteroanastomosis.

8. The instrumentation according to one of claims 4-7, further characterized in that it comprises means for preliminarily making a gastric pouch; said second tissue portion (14) of the stomach that is placed in the gastric pouch.

9. The instrumentation according to one of claims 4-8, characterized in that the means used are adapted to perform the laparoscopic gastrointestinal bypass.

10. The instrumentation according to one of claims 1-3, further characterized in that the means for approximating the tissue portions comprise an anastomotic device adapted to approximate the tissues intraluminally.

11. The instrumentation according to one of claims 1-3, further characterized in that the means for creating the gastroenteroanastomosis (16) and / or enteroenteroanastomosis (22) comprise an anastomotic instrument adapted to perform the gastroenteroanastomosis (16) and / or enteroenteroanastomosis (22) ntraluminally.

12. The instrumentation according to claim 10 or 11, further characterized in that it comprises a guiding means in which the anastomotic instrument is blocked or slid, said guiding means is preliminarily inserted through the portions of tissue that go to approach or join, forming an open loop.

13. The instrumentation according to claim 12, further characterized in that it comprises means for partially making a gastric pouch before inserting said guide means, said second portion of tissue (14) of the stomach is placed in the gastric pouch.

14. The instrumentation according to claim 13, further characterized in that it comprises means for completing the gastric pouch after the formation of the gastroenteroanastomosis and enteroenteroanastomosis.

15. - The instrumentation according to claim 12, further characterized in that it comprises means for making a gastric pouch after the formation of the gastroenteroanastomosis (16) and enteroenteroanastomosis (20), said second portion of tissue (14) of the stomach is placed or disposed in the gastric pouch