WO2025164937A1 - Anastomosis device having new arrangement for improving end-to-end anastomosis of intestines - Google Patents

Abstract

The present application relates to an anastomosis device having a new arrangement for improving the end-to-end anastomosis of the intestines, the device comprising: an anvil head having an anvil inserted into a proximal intestine, and an anvil shaft extending from the anvil to one side; and a stapler having, at the front end portion thereof, a trocar forming an anvil-coupling with the anvil shaft, wherein the trocar is inserted into the anvil shaft from the side surface of the anvil shaft so that the anvil-coupling can be formed.

Description

A novel arrangement of anastomotic devices to improve the end-to-end anastomosis of the intestine

This paper relates to a novel arrangement of anastomotic devices for improving the end-to-end anastomosis of intestines.

While intestinal resection and anastomosis have long been a familiar technique for surgeons, it remains a critically important procedure due to the potentially life-threatening complications associated with it, such as anastomotic leakage. The shift from the traditional manual approach to modern stapler devices has led to more standardized surgical outcomes.

A circular stapler (9) as a conventional anastomosis device as shown in Fig. 1 may include a stapler (91) inserted into the anus and an anvil head (92) placed in the intestine, and the stapler's trocar (93) and anvil shaft (94) are respectively positioned in the intestine where the anastomosis is to be performed and then joined to each other to perform the anastomosis.

Currently, staplers are widely used worldwide, and laparoscopic surgery has become widespread. However, unlike open surgery, the use of staplers in laparoscopic surgery presents challenges, including difficulty in handling, the risk of intestinal perforation, and instability of intestinal anastomoses.

The anvil shaft and the trocar that form the connection are formed in a straight line, but in actual clinical practice, it is difficult to align the anvil shaft and the trocar in a straight line, and the space for inserting the trocar inside the anvil shaft is small, making it difficult to insert the trocar itself.

When connecting the two sides of the intestine during laparoscopic surgery, the anvil head is inserted into the proximal intestine to expose the anvil shaft and fix it, and the stapler is inserted through the anus into the distal intestine (usually the rectum or sigmoid colon) and the trocar is advanced to create an artificial perforation at the distal end of the intestine to expose it. Then, the exposed anvil shaft and trocar are manipulated to perform the connection. At this time, the anvil shaft exposed at the proximal end of the intestine and the trocar exposed at the distal end of the intestine are not aligned parallel, making it difficult to manipulate when connecting using laparoscopic instruments. In addition, if the direction of force for alignment is wrong, there is a risk of perforating the distal intestine.

In addition, the diameter of the hole through which the trocar is inserted into the anvil shaft is very small, less than 4 mm, making it difficult to insert the trocar itself.

The technology underlying this invention is disclosed in European Patent No. EP0698376B1.

The present invention is intended to solve the problems of the prior art described above, and the purpose of the present invention is to provide a surgical instrument in which a stapler needle is inserted through the side of an anvil shaft to enable easy anvil connection.

In addition, the present invention aims to provide a suturing mechanism that enables anvil coupling even when the anvil is not aligned parallel to the stapler when the anvil head and the stapler are coupled by providing a joint that allows pivotal movement between the anvil shaft and the anvil.

However, the technical tasks to be achieved by the embodiments of the present invention are not limited to the technical tasks described above, and other technical tasks may exist.

As a technical means for achieving the above-mentioned technical task, a stapler according to one embodiment of the present invention comprises: an anvil head having an anvil inserted into a proximal intestine and an anvil shaft extending from the anvil to one side; and a stapler having a trocar at a distal end forming an anvil joint with the anvil shaft, wherein the trocar can be inserted from a side of the anvil shaft into the interior of the anvil shaft to form the anvil joint.

In addition, according to one embodiment of the present invention, the anvil shaft includes an insertion guide portion having a guide opening formed on one side thereof that extends along a direction in which the anvil shaft extends, and the piercing needle can be inserted into a coupling space inside the anvil shaft through the guide opening.

Additionally, according to one embodiment of the present invention, the guide opening may be formed so that its size expands when the trocar passes through the guide opening, and its size decreases after the trocar passes through the guide opening.

In addition, according to one embodiment of the present invention, the insertion guide portion may be provided on the end side of the anvil shaft, and the coupling space may be provided to extend from one end of the anvil shaft further toward the anvil than the insertion guide portion, so that the trocar may be inserted into the anvil shaft through the insertion guide portion and then inserted and fixed toward the anvil.

In addition, according to one embodiment of the present invention, the stapler further includes an indicator provided on one side of the trocar so that the insertion and fixation of the trocar is externally identifiable, and the indicator may be provided so that the trocar has a predetermined set positional relationship with the anvil shaft without being inserted into the anvil shaft when the trocar is inserted and fixed inside the anvil shaft.

Additionally, according to one embodiment of the present invention, the anvil shaft may further include a pivot portion that guides a hinge movement of the anvil shaft so that the anvil shaft can pivot relative to the anvil.

Additionally, according to one embodiment of the present invention, the pivot portion may have a ball socket joint structure.

The above-described problem-solving methods are merely exemplary and should not be construed as limiting the present invention. In addition to the exemplary embodiments described above, additional embodiments may be included in the drawings and detailed description of the invention.

According to the above-described solution to the problem of the present invention, the present invention can more easily align the anvil and stapler even when the proximal and distal segments to be connected are not aligned because the joint movement of the pivot part is free, and in particular, during laparoscopic surgery, the camera's line of sight and the field of view of the anvil assembly are aligned and the surgical field is not obstructed, so that it is possible to visually observe whether a safe anastomosis is performed.

In addition, the present invention allows for easy coupling by expanding the area in which the trocar can be inserted into the anvil shaft by passing the trocar through the side of the anvil shaft, and when the anvil shaft is held with a laparoscopic instrument, the anvil coupling can be easily performed according to joint movement.

However, the effects achieved by the embodiments of the present invention are not limited to the technical tasks described above, and other effects may exist.

Figure 1 is a drawing illustrating a conventional anastomosis device including an anvil and a stapler.

Fig. 2 is a drawing showing a part of a ligation device (1) according to one embodiment of the present invention.

Figure 3 is a drawing showing a cross-section of a trocar needle (32) and an insertion guide part (121) according to one embodiment of the present invention.

Figure 4 is a cross-sectional view of an anvil head (10) according to one embodiment of the present invention.

FIG. 5 is a schematic drawing showing an anvil shaft (12) rotating relative to an anvil head (11) according to a pivot part (123) according to one embodiment of the present invention.

Figure 6 is an enlarged view of a portion of a pivot part (123) and anvil shaft (12) according to one embodiment of the present invention.

Below, with reference to the attached drawings, embodiments of the present invention are described in detail to facilitate easy implementation by those skilled in the art. However, the present invention can be implemented in various different forms and is not limited to the embodiments described herein. In the drawings, irrelevant parts have been omitted for clarity, and similar reference numerals have been used throughout the specification to indicate similar elements.

Throughout this specification, when a part is said to be "connected" to another part, this includes not only "directly connected" but also "indirectly connected" with another component in between or "electrically connected" with a component in between.

Throughout this specification, when it is said that a member is located “on,” “above,” “upper,” “lower,” “lower” or “lower” another member, this includes not only cases where the member is in contact with the other member, but also cases where another member exists between the two members.

Throughout this specification, whenever a part is said to "include" a component, this does not mean that it excludes other components, but rather that it may include other components, unless otherwise specifically stated.

Terms such as "first~", "second~" may be used to indicate the same or substantially the same configuration in a different order, and may be interpreted as a configuration that is substantially the same as a configuration that is not indicated as "first", "second", etc.

In addition, terms related to direction or location (upper side, upper surface, lower side, etc.) in the description of the embodiments of the present invention are set based on the arrangement state of each component shown in the drawing.

Hereinafter, a surgical instrument (1) according to one embodiment of the present invention will be described. The surgical instrument (1) according to one embodiment of the present invention may be understood to focus on the connection between the anvil shaft of an anvil used for end-to-end anastomosis of intestines and the trocar of a stapler, i.e., the anvil coupling. The surgical instrument (1) according to one embodiment of the present invention may include an anvil head (10) and a stapler (30).

Referring to Fig. 2, a portion of the anvil head (10) is inserted into the distal end of the proximal intestine, and an end-to-end intestinal anastomosis is performed through anvil connection with a stapler (30) described later. The anvil head (10) can be fixed through a suture after being inserted into the proximal intestine, and a portion thereof can be provided to be exposed to the distal side. The anvil head (10) can include an anvil (11) inserted into the proximal intestine, and an anvil shaft (12) extending to one side from the anvil.

The anvil (11) is configured to be inserted into the proximal part and may have a wider cross-section than the anvil shaft (12). One distal side of the anvil (11) may have a shape that induces the staples fired from the stapler (30) to bend.

An anvil shaft (12) may extend distally from one distal side of the anvil (11). The anvil shaft (12) is provided to be exposed from the proximal end to form an anvil connection with the stapler (30). The anvil shaft (12) may have a distal end formed therein, i.e., a connection space (12a) for connection with the stapler. The connection space (12a) may extend from the distal end of the anvil shaft to the anvil (11), i.e., the proximal end.

In one embodiment, the anvil shaft (12) may be provided such that a diaphragm (32) described later is inserted into the anvil shaft (12) from the side of the anvil shaft (12) to form an anvil joint. The anvil shaft (12) may include an insertion guide portion (121), a pivot portion (123), and a fixing portion (124).

Referring to FIGS. 2 and 3, an insertion guide portion (121) is formed on the distal end side of the anvil shaft (12) to guide the lateral insertion of the trocar (32). That is, the trocar (32) can be inserted into the interior of the anvil shaft (12) from the side through the insertion guide portion (121).

The insertion guide portion (121) may have a guide opening (121a) formed on one side thereof, through which a trocar (32) may be inserted into the internal space (12a). The guide opening (121a) may extend along the direction in which the anvil shaft (12) extends. That is, the guide opening (121a) may be understood as a slit or opening formed along the proximal-distal direction, through which a trocar may be inserted.

In one embodiment, the guide opening (121a) may be formed so that its size expands when the trocar (32) passes through the guide opening, and its size decreases after the trocar passes through the guide opening. As illustrated in FIG. 3, the width of the guide opening (121a) before the trocar (32) is inserted into the joining space (12a) may be smaller than the diameter of the trocar. When the trocar (32) passes through the guide opening (121a) upon lateral insertion of the trocar (32), the size (width) of the guide opening increases to allow the trocar (32) to pass through, and when the trocar passes through the guide opening and is accommodated inside the joining space (12a), the size (width) of the guide opening decreases again to prevent the trocar (32) from falling out.

For example, in order to change the size of the guide opening (121a), the insertion guide part (121) may be provided with an elastic material. At this time, the guide opening (121a) may be provided so that the size thereof can increase as the trocar (32) approaches from the outside of the insertion guide part (121), while the guide opening (121a) may be provided so that the size thereof does not increase when the trocar (32) tries to fall out laterally from the inside of the insertion guide part (121).

It can be understood that the end (1211) of the guide opening (121a) slides inward like the trocar (32) when the trocar is inserted laterally, and then elastically restores when the trocar is fully inserted into the joining space (12a), narrowing (closing) the width of the guide opening (121a).

To this end, the end (1211) of the guide opening (121a) of the insertion guide portion (121) may be formed to be curved inward to a predetermined degree. In addition, the end (1211) may be provided to protrude inwardly to a predetermined degree where the joining space is formed, so that the width of the guide opening (121a) does not widen even when the trocar (32) moves laterally.

However, the configuration for changing the size of the guide opening (121a) is not limited to the above-described embodiment, and another configuration may be used in which the piercing needle (32) is inserted into the anvil shaft (12) through the guide opening from the side and is prevented from being removed from the anvil shaft in the side direction.

As illustrated in Fig. 4, the coupling space (12a) may extend from one end of the anvil shaft further toward the anvil head (11) than the insertion guide portion (121). Accordingly, the piercing needle (32) may be inserted into the anvil shaft through the insertion guide portion (121) and then inserted and fixed toward the anvil head.

The length by which the insertion guide portion (121) extends from the distal end of the anvil shaft may be shorter than the length by which the joining space (12a) extends from the distal end of the anvil shaft. In this way, when the stapler (30) is pushed toward the anvil (11) after the trocar (32) is inserted laterally through the insertion guide portion (121), the trocar (32) can be inserted and fixed within the anvil shaft (12) by engaging with the upper end of the anvil shaft (12).

Referring to FIGS. 2, 4, and 5, the pivot portion (123) may be provided so that the anvil shaft (12) can rotate at a predetermined angle relative to the anvil (11) when the anvil head (10) and the stapler (30) are brought close together for anvil coupling between the anvil shaft (12) and the trocar (32). That is, the anvil shaft (12) can perform a joint movement within a predetermined range relative to the anvil (11) through the pivot portion (123), so that alignment for anvil coupling can be easily performed.

In one embodiment, the pivot member (123) may be provided to guide the hinge movement of the anvil shaft (12) so that the anvil shaft (12) can pivot relative to the anvil (11). For example, the pivot member (123) may have a ball-socket joint structure including a ball (1231) on the anvil shaft side and a socket (1232) on the anvil side.

The socket (1232) can allow the ball (1231) and the anvil shaft (12) connected to the ball to hinge relative to the socket (1232) within a predetermined angular range. Here, the predetermined angular range is preferably set to an angular range that allows the surgeon to easily align the anvil shaft (12) and the trocar (32) in parallel within the abdominal cavity.

In addition, according to one embodiment of the present invention, when the anvil shaft (12) and the trocar (32) are combined and the stapler (30) fires staples to close the anastomosis site and then the anastomosis device (1) is pulled back to remove the anvil-coupled assembly, the pivot movement by the pivot part (123) allows free movement of the anvil (11) when it receives resistance against the staple line fired in a circular direction, thereby reducing damage to the anastomosis site that may occur when the assembly is removed. Compared to a method in which the angle of the anvil (11) is adjusted perpendicularly after the stapler (30) fires staples to close the anastomosis site, the pivot movement can be generated in a direction or angle that can minimize resistance according to the direction of the resistance of the anvil (11) against the staple line.

Additionally, the pivot part (123) may be provided so that the anvil shaft is fixed so as not to pivot relative to the anvil head when the piercing needle is inserted and fixed toward the anvil head in the coupling space.

Referring to Fig. 6, the fixing member (124) may be provided to fix the pivot member (123) by fixing the trocar (32) within the coupling space (12a). The trocar (32) may be inserted into the coupling space (12a) inside the anvil shaft (12) through the insertion guide member (121) and may be inserted and fixed within the coupling space (12a). The fixing member (124) may be provided to limit the hinge movement of the pivot member (123) as the trocar (32) is inserted and fixed.

In one embodiment, the fixing member (124) may be provided within the joining space (12a) to pressurize one side of the ball (1231) upon insertion of the diaphragm (32). As the fixing member (124) presses the ball (1231), rotation of the ball (1231) within the socket (1232) is restricted, thereby preventing hinge movement of the pivot member (123).

For example, one end of the fixed part (124) may be provided to receive a compressive force according to the insertion and fixation of the trocar (32) within the joint space (12a), and the other end may be provided to transmit the compressive force according to the insertion and fixation of the trocar (32) to the ball (1231) so that the ball (1231) is fixed within the socket (1232).

In comparison with the prior art in which the angle between the anvil and the shaft can be bent to prevent the anvil from getting caught when removing the stapler, the pivot part (123) and the fixing part (124) according to the embodiment of the present invention can allow the angle between the anvil (11) and the anvil shaft (12) to be changed before the anvil is coupled, and when the trocar (32) is completely inserted and fixed within the coupling space (12a) and the anvil is coupled, the hinge movement through the pivot part (123) can be fixed so that it cannot be changed. That is, it can be understood by those skilled in the art that the angle between the anvil and the anvil shaft in the prior art changes after the anvil is coupled, but the anastomosis device of the present invention is fixed so that the angle between the anvil and the anvil shaft cannot be changed through the pivot part (123) after the anvil is coupled.

A stapler (30) can be inserted into the distal intestine through the anus and perform end-to-end intestinal anastomosis through the anvil (10) and anvil combination described above. The stapler can anastomose the anastomosis site by firing staples through the surgeon's manipulation, and the execution of the anastomosis after firing the staples and joining the anvil can be understood by referring to the operation of an anastomosis device or stapler that has been disclosed or is known in the art.

In one embodiment of the present invention, a stapler (30) may be inserted into the anvil shaft so that a trocar can be approached from the side of the anvil shaft and inserted into the interior, to facilitate easier coupling when forming an anvil connection with the anvil (10). The stapler (30) may include a head portion (31), a trocar (32), and an indicator (33).

The head portion (31) is provided at the front end of the stapler (30), and can be inserted through the anus and into the distal intestine. A trocar (32) can be extended from the head portion (31) to the proximal side.

The trocar (32) forms an anvil connection with the anvil shaft (12) at the tip of the stapler, and can be inserted from the side through the insertion guide portion (121) formed in the anvil shaft (12). The trocar (32) may have a shape that tapers toward the end, which can be understood by referring to the shape of a known trocar (32).

In one embodiment, it is preferable that the diameter of the trocar (32) be larger than the width of the guide opening (121a) before lateral insertion of the trocar.

Referring again to FIG. 2, an indicator (33) may be provided on one side of the trocar (32) so that the insertion and fixation of the trocar can be externally identifiable. For example, the indicator (33) may be formed on the outer surface of a rod extending from the head portion (31) to the proximal trocar (32). The indicator (33) may be formed so that it is easily identifiable from the outside, and for example, may be provided in the shape of an orange or other predetermined color band on the outer surface of the rod.

In one embodiment, the indicator (33) may be provided so that the diaphragm (32) is not inserted into the anvil shaft (12) when the diaphragm (32) is inserted and fixed inside the anvil shaft (12). The indicator (33) may have a predetermined positional relationship with the anvil shaft (12) on one side outside the anvil shaft (12).

Referring to the illustrated embodiment, the indicator (33) is provided to be positioned on the distal side of the insertion guide part (121) when the trocar (32) is inserted and fixed, so that the surgeon can easily confirm that the anvil coupling is completed by seeing that the indicator (33) and the insertion guide part (121) are adjacent in addition to the fixation of the trocar (32). In order to easily confirm the positional relationship between the indicator (33) and the anvil shaft (12), the outer surface of the insertion guide part (121) may also be provided with a predetermined shape, and in one embodiment, a band shape of a different color from the indicator (33) may be provided.

The above description of the present invention is for illustrative purposes only, and those skilled in the art will readily appreciate that the present invention can be readily modified into other specific forms without altering the technical spirit or essential characteristics of the present invention. Therefore, the embodiments described above should be understood as illustrative in all respects and not restrictive. For example, each component described as a single entity may be implemented in a distributed manner, and similarly, components described as distributed may be implemented in a combined manner.

The scope of the present invention is indicated by the claims described below rather than the detailed description above, and all changes or modifications derived from the meaning and scope of the claims and their equivalent concepts should be interpreted as being included in the scope of the present invention.

[Explanation of symbols]

1: Anastomotic device

10: Anvil Head

11: Anvil

12: Anvil shaft

121: Insertion guide section

121a: Guide Opening

123: Pivot

124: Fixed part

30: Stapler

31: Head

32: Trocar needle

33: Indicator

Claims (6)

In an anastomosis device for the end-to-end anastomosis of the intestine, An anvil head having an anvil inserted into the proximal side of the body and an anvil shaft extending to one side from the anvil; and A stapler having a trocar having an anvil shaft and an anvil joint formed at the tip, A fusion device wherein the above-mentioned trocar is inserted into the interior of the anvil shaft from the side of the anvil shaft to form the anvil joint. In the first paragraph, The anvil shaft includes an insertion guide portion having a guide opening formed on one side thereof that extends along the direction in which the anvil shaft extends, A surgical instrument, wherein the above-mentioned trocar is inserted into the joining space inside the anvil shaft through the above-mentioned guide opening. In the second paragraph, An anastomosis device wherein the guide opening is formed so that its size expands when the trocar passes through the guide opening and its size decreases after the trocar passes through the guide opening. In the third paragraph, The stapler further includes an indicator provided on one side of the trocar so that the insertion and fixation of the trocar is externally identifiable, The above indicator is provided so that the anvil shaft has a predetermined set positional relationship with the anvil shaft when the trocar is inserted and fixed inside the anvil shaft without being inserted inside the anvil shaft. In the second paragraph, A joint mechanism, wherein the anvil shaft further includes a pivot portion that guides the hinge movement of the anvil shaft so that the anvil shaft can pivot relative to the anvil. In paragraph 5, A joint mechanism, wherein the pivot part has a ball socket joint structure.