WO2008081210A1

WO2008081210A1 - Surgical stapler adjusted to a special surgical glove

Info

Publication number: WO2008081210A1
Application number: PCT/GR2008/000001
Authority: WO
Inventors: Georgios Trogadas
Original assignee: Georgios Trogadas
Priority date: 2007-01-05
Filing date: 2008-01-07
Publication date: 2008-07-10
Also published as: GR1005765B

Abstract

A surgical stapler incorporated in a special surgical glove used in the procedure of stapling and anastomosis of hollow abdominal organs. Due to its shape, size and ergonomy, it can reach anatomic spaces to which the usual lineal articulating staplers (Roticulator - TYCO, Proximate Access - ETHICON) and the modern curved head fixed staplers (Contour - ETHICON) cannot access. This is achieved due to the minimization of the voluminous accessories compared to the usual surgical staplers and due to the incorporation of the stapler in the surgeon's hand, a fact that is correlated with the great ergonomy and ease of use. It is mainly used in the low anterior resection of the rectum, where it replaces the voluminous and inconvenient staplers such as TYCO's Roticulator, ETHICON' s Proximate Access and Contour, during the procedure of stapling and the division of the rectum in a distal and a proximal part. The other operation stages for the placement of the circular stapler (CEEA) device and the anastomosis remain the same.

Description

SURGICAL STAPLER ADJUSTED TO A SPECIAL SURGICAL GLOVE

The invention refers to a surgical stapler used in the stapling-anastomosis of hollow abdominal organs (esophagus, small and large intestine, rectum, stomach) which is adjusted to a special surgical glove.

The surgical staplers replaced the human hand in the anastomosis of hollow abdominal organs, offering ease, speed, safety and less need for great specialization, experience and skill on behalf of the surgeon.

At the same time, they made the anastomosis practicable in cases where this would not be possible with sutures effected by the human hand (e.g. very low anterior resection of the rectum), releasing the surgeon from the need to perform amputating operations such as the abdominoperineal resection with a permanent colostomy, with all the consequences for the patient.

None the less, the staplers that have been manufactured up to date, due to their size and volume but also due to the lack of anatomy and ergonomy, become very often (especially in difficult operations) inconvenient and voluminous. They cannot reach various anatomic spaces except with violent or sightless movements and they are certainly subject to a self-limitation of the point up to which they can reach an anatomic space. This could make things hard for the surgeon and even cause injuries to the adjacent organs. They also make some anastomoses precarious due to the major difficulties that arise. For example, in the very low anterior resection of the rectum (the anastomosis of the intestine is performed lower than 5-6 cm away from the anal verge), the head of the stapler is forwarded deep in the pelvis, so the possibility to perform the anastomosis, and its depth especially in men (narrow pelvis) is actually conditioned by the depth that the stapler's head can reach. The lower rectum (in a height of 3-8 cm away from the anal verge) usually has a diameter of 40 mm and as a result the usual articulating linear staplers as Roticulator and Proximate Access, those of 30 mm, on the one hand, are small and cannot accomodate the entire rectum in their jaws, while those of 50 mm on the other hand, are voluminous and cannot get deep into the pelvis. Using another example in the vertical gastroplasty as per Mason technique, the voluminous stapler with the longitudinal body, can be placed and extend to the gastroesophageal junction with great difficulty.

Another major disadvantage of the currently used staplers is the lack of the touch sensation on the surgeon's hand (tactile feedback) and the lack of possibility to manipulate the various tissues.

The stapler, incorporated in the surgical glove, refers to a device for the stapling of hollow organs using metal clips, wherein its mechanic parts are contained in the palm of the surgeon, facilitating penetration to inaccessible anatomic spaces. The heads-cartridges are between the surgeon's fingers and they are bended and articulated in the same parts with the fingers' articulations. The shaft-head fastener, as well as the two cartridges between them, are articulated.

The stapler, adjusted to the surgical glove, has an advantage over the other staplers (articulating linear staplers - Roticulator and the modern curved head fixed staplers - Contour) for the following reasons:

A) It is adjusted to the surgeon's hand and does not take up space.

B) Bodies and protrusions that make the device hard to use and in many cases unpractical are avoided. C) It can follow the surgeon's hand while it reaches various anatomic spaces without the need for the surgeon to remove firstly his hand, and then place the device without having optical view.

D) It preserves the touch sensation in the fingers (tactile feedback) and thus the surgeon may manipulate the dangerous spots and the anatomic structures to which in another case he would cause an injury.

E) It can reach a greater depth compared to other staplers, effecting anastomoses that otherwise could not be performed, resulting to fewer amputating operations. Thus, in cases of cancer, it ensures greater safety distance from the tumor.

F) Injuries to adjacent organs are avoided, due to its minimal size and to the elimination of the useless voluminous parts.

G) The percentage of complications is diminished due to the rninimization of the difficult and impossible technical operations.

H) The operation time is reduced due to its easier placement. I) No great surgical skill or experience is required.

J) During the stage of the rectum division with a surgical blade on the existing slot in the cartridge with the clips, the injuries of the adjacent tissues and organs are avoided since the division is performed in the surgeon's palm in a controllable manner.

The figures below show, the first two (FIGURE 1, FIGURE 2) the stapler with the firing mechanism placed in the palm, whilst the third and fourth figure (FIGURE 3, FIGURE 4) show the stapler with the firing mechanism located in the arm. hi the first and third figure (FIGURE 1, FIGURE 3) the configuration of the glove has been removed and only its main mechanical parts are shown. The second and fourth figure (FIGURE 2, FIGURE 4) shows the stapler incorporated into the surgeon's hand. The fourth figure (FIGURE 4) shows the surgeon's optical view during the placement of the stapler deep in the pelvis, with the rectum (not shown in the figure) being accommodated in its legs. The stapler adjusted to a surgical glove comprises of a special type of sterilized surgical glove (1) waterproof and microbe-safe that may be worn alone or over a normal surgical glove. The shaft (7) of the stapler is placed in the palm and has a slightly bent shape in order to follow the shape of the bended palm - wrist and extends to the medium part of the arm so that it may be positioned with no protrusions and obstacles when passing through the organs and structures of the abdomen. The shaft (7) of the stapler from the area of the articulated fastener (8) with the heads-jaws (2) up to the area ending to the locking-firing mechanism (5) is flexible, hi this way, the surgeon may regulate it by bending it hi the proper parts so as to follow the normal angles and curves of the radiocarpal articulation and the metacarpophalangeal articulations during the stapler's placement in the proper anatomic space. Alternatively, the shaft (7) may have pre-formulated curves in its route, that follow the normal curves hi the area of the radiocarpal articulation and in the palm respectively, during the light flexion of the radiocarpal articulation and of the respective flexion of the metacarpophalangeal articulations.

Besides, the regulation of the desirable aperture width of the jaws-heads considering the tissue thickness, the local conditions and the size of the pelvis, is possible with the articulating fastener of the heads (8) with the shaft (7) of the stapler, situated in the palm, next to the interdigital fold. This articulated fastener of the heads (8), in addition to the regulation of the aperture width of the heads- jaws (2), allows the shift of the angle formed between the heads and the stapler's shaft (7). This makes possible the further angulation or extension of the fingers bearing the heads-jaws, without leaving the stapler's shaft inflexible (depending on the local surgical conditions). hi the inner lateral surface of the index and the middle finger, the plastic surfaces (heads-jaws) are adjusted opposite to each other (2) i) bended in three spots (A,B,r) (fixed or articulated in these spots) so as to follow the normal angles of the fingers' flexion when the fingers are capturing an object [i.e. 110-130°]. The purpose is for the stapler to achieve a lower pelvic access with the flexion of the fingers [index and middle finger], or ii) straight (depending on the type of the stapler). The heads-jaws have a stapler line of 50 mm and 90 mm respectively and contain the rows of metal clips (3) and the mate slot in which these shall be bent after the stapling, to take their final shape. Depending on the hollow organs that we wish to staple, there are also heads-jaws with metal clips for tissues with a thickness a) of up to 1.5 mm and b) above 1.5 mm and a stapler line of 30 / 45 / 50 / 55 / 60 / 90 mm.

In the part of the glove which is in the interdigital fold of the index and the middle finger is the articulated fastener of the heads-jaws (8), whilst the shaft (7) is incorporated in the area of the glove that covers the palm and extends to the middle part of the arm (where the glove ends) and continues with the trigger handles (9), the locking and firing mechanism (5) which remain uncovered by the elastic glove. hi the first type of stapler (for low anterior rectal resection), the palm is positioned in a moderate palm flexion with the fingers slightly bended having the shape of grasping an object. The index and the middle finger are in 90° angle in relation to the metacarpophalangeal articulations. In the second type of stapler (gatroplasty as per Mason technique), the index and the middle finger are at 180° in relation to the metacarpophalangeal articulations, hi both types, the thumb, the ring finger and the little finger are free to move and to assist the stapler's placement.

In the distal part of the main shaft (7) and in the upper part of the trigger handles (9), there is an occlusion mechanism (10) of the heads-jaws, which when activated grasps and stabilizes the intestine between the heads-jaws (2), being also able to be locked-unlocked in order to correct any mistakes in the placement of the intestine. This step is the last one before the final firing of the clips (3), effected with the locking and firing mechanism (5) and after the removal of the protective cam wedge (safety) (6) between the locking and firing mechanism (5) and the trigger handles (9). Depending on the type of stapler, the locking and firing mechanism (5) may be placed: a) in the palm, activated with the pressure of the little or the ring finger or both fingers (by palm flexion of those). b) alternatively, it may be on the level of the arm, through the flexible body — shaft (7) bearing the necessary fasteners and accessories to transmit the acts and movements from the level of the arm, on the cartridges to the heads-jaws (2) positioned on the index and the middle finger. In this case, the locking- unlocking and firing are performed with the other (free) hand of the surgeon.

In both cases, we distinguish the trigger handles (9) and the locking-firing mechanism (5) and so we have: a) the grasping of the tissue between the heads-jaws (2), by activating the occlusion mechanism (10) of the heads-jaws and b) the release of the locking safety (6), the firing of the clips (3) and their release after the activation of the locking-firing mechanism (5) resulting to c) the stapling of the tissue.

The head-jaw (2) bearing the cartridge disposes a slot (4) housing a blade- scalpel for the division of the tissue to be performed at the end of the clips (3) application, leaving behind a stapled distal edge and its proximal part with an open lumen. Alternatively, there may be an incorporated blade between the two rows of the clips, so that the rectum stapling and division may be performed simultaneously. EXAMPLE l

In the low anterior resection of the rectum it is necessary to prepare the rectum down to the levator diaphragm. In this case the stapler can be used.

The above described stapler can be placed on the left or the right hand of the surgeon depending on his preference and dexterity. The surgeon lowers his/ her hand together with the stapler in the desirable depth of the pelvis, having the rectum accommodated between the cartridges of the head-jaws, being able at the same time to manipulate and feel with the other fingers (thumb, ring finger, middle finger but also the dorsal surface of the index and the middle finger) the adjacent tissues. In this manner, he avoids abusing the tissues or including in the stapler line other organs or tissues. When he reaches the desirable depth (approximately in the dentate line of the rectum), he/ she grasps and stabilizes the rectum between the legs-cartridges of the heads-jaws (Step A). Following that, and provided he/ she makes sure that the depth is correct and that between the legs of the head there is no other tissue accommodated except the rectum, he unlocks the protective cam wedge (safety) (Step B), he activates the occlusion mechanism (10) of the heads-jaws and fires (Step C) pressing hard the ring finger or the little finger or both on the locking and firing mechanism (5). (Alternatively, he fires with the other hand). As a result, the intestine lumen is stapled and closed with two rows of metal clips, which is the first and most difficult step in the standard anastomosis with the circular staplers (CEEA).

Then, he/ she cuts the central part of the rectum with a blade on the existing slot of the cartridge, he unlocks and releases the distal rectal stamp which now bears two rows of overlapped metal clips along a stapler line of 45 mm. Alternatively, there may be an incorporated blade between the two rows of clips, so as to perform the stapling and the division of the rectum simultaneously. The remaining anastomosis procedure is the typical one.

EXAMPLE 2 During the Mason's technique for the vertical gastroplasty, the stapler may be used to staple the stomach wall and to create a pouch (neostomach), avoiding the use of the voluminous stapler of multiple uses with 4 rows of clips. The first step is to surgically prepare and loop the gastroesophageal junction, then create a hole with the circular stapler (CEEA) in the lesser curvature of the stomach and finally to place the stapler with one head-jaw into the posterior wall of the stomach and the other head into the anterior wall. Due to the small size and handiness of the tool, the operation time is accelerated and simplified. hi this case, the length of the cartridges is 90 mm and as a result the cartridges protrude from the fingers (index and middle finger) but this does not affect the proper placement of the stapler. The palm is also at full length with the fingers being to their full extent too.

Claims

1) A surgical device comprising a surgical stapler for hollow abdominal organs adjusted to a special type sterilized surgical glove, wherein the stapler is incorporated into the glove which is put on alone or over the ordinary sterilized gloves offering thus great anatomy, ergonomy and touch sensation to the surgeon. The heads-jaws (2) of the stapler are firmly adjusted to the opposite surfaces of the fingers of the glove (inner side surface) housing the index and the middle finger (alternatively the heads-jaws may also be placed between the thumb and the index, between the middle finger and the ring finger and between the ring finger and the little finger of both hands), the articulated fastener of the heads- jaws (8) is situated in the part of the glove that is in the interdigital fold of the index and of the middle finger whilst the shaft (7) is incorporated in the area of the glove covering the palm and reaching up to the middle part of the arm (where the glove ends) and continues with the trigger handles (9), the locking and firing mechanism (5) which remain uncovered by the elastic glove. 2) A surgical stapler adjusted to a special surgical glove as claimed in claim 1, comprises the heads-jaws (2) bearing cartridges with metal clips (3), which are adjusted to the glove fingers and to the shape of the bended fingers while they capture an object. The index and the middle finger (of the left or the right hand depending on the dexterity of the surgeon) are placed in the fingers of the glove. Depending on the type of stapler, it is also comprised by the existence of the locking and firing mechanism (5): a) in the palm, the mechanism is activated pressing the ring finger and the little finger or both of them, and b) on the level of the arm, through a flexible shaft (7) bearing the necessary fasteners and accessories to transmit the acts and movements from the level of the arm on the head-jaws (2) placed on the index and the middle finger. In this case, the locking-unlocking and the firing are performed with the other (free) hand of the surgeon.

3) A surgical stapler of hollow organs as claimed in claim 2, comprises the heads-jaws (2) bearing clips (3) which are bended in three spots (A,B,O (fixed or articulated in these spots) so as to follow the normal angles of the hand fingers flexion when they bend and capture an object (e.g. 110-130° angle). In this way, the stapler reaches lower pelvic access by flexing the fingers (index and middle finger). Alternatively, the heads-jaws (2) may also be straight and parallel between them, without forming angles and so the fingers bearing heads can remain at full length (Stapler for gastroplasty as per Mason technique). 4) A surgical stapler of hollow organs as claimed in claim 3, comprises the heads-jaws which are bended in three spots (A₅B₅O (fixed or articulated in these spots) bearing a slot housing a blade-scalpel (4) so that the division of the tissue can be performed at the end of the application of the clips (3), leaving behind a stapled distal edge and its proximal part with an open lumen. Alternatively, there may be an incorporated blade between the two rows of the clips (3) so that stapling and division of the rectum may be performed simultaneously.

5) A surgical stapler of hollow organs as claimed in claim 4, comprises the heads-jaws (2) bearing metal clips for tissues with a thickness a) of up to 1.5 mm and b) above 1.5 mm and a stapler line of 30 / 45 / 50 / 55 / 60 / 90 mm depending on the hollow organs that need to be stapled.

6) A surgical stapler of hollow organs as claimed in claim 5, comprises the articulated fastener (8) of the heads-jaws with the shaft (7) of the stapler which is situated in the palm, next to the interdigital fold, so as to regulate the desirable aperture width of the heads-jaws (2) depending on the tissue thickness and the local conditions-size of the pelvis.

7) A surgical stapler of hollow organs as claimed in claim 6, comprises the articulated fastener (8) between the heads-jaws with the shaft (7) of the stapler which allows, in addition to the regulation of the aperture width of the heads-jaws (2), the shift of the angle formed between the heads-iaws and the shaft (7) of the stapler. This makes possible the further angulation or extension of the fingers bearing the heads-jaws (depending on the local surgical conditions).

8) A surgical stapler of hollow organs as claimed in claim 7, comprises the shaft (7) of the stapler which is placed in the palm starting from the level of the articulated fastener (8) and has a slightly bent shape in order to follow the shape of the bended palm - wrist and extends to the middle part of the arm so that it may be positioned with no protrusions and obstacles when passing through the organs and structures of the abdomen.

9) A surgical stapler of hollow organs as claimed in claim 8, comprises the shaft (7) of the stapler from the area of its articulated fastener (8) with the jaws up to the area ending to the firing mechanism which is flexible so that the surgeon may regulate it by bending it in the proper parts to follow the normal angles and curves of the radiocarpal articulation and the metacarpophalangeal articulations in 5 the stapler's placement in the proper anatomic space. Alternatively, the shaft (7) may have pre-formulated curves in its route, that follow the normal curves in the area of the radiocarpal articulation and in the palm respectively, in the slight flexion of the radiocarpal articulation and the respective flexion of the metacarpophalangeal articulations.

10 10) A surgical stapler of hollow organs as claimed in claim 9, comprises the handle (9) and the locking and firing mechanism (5), on the level of the middle part of the arm or above it, which can: a) grasp the tissue between the heads-jaws (2), after the activation of the occlusion mechanism (10) of the heads-jaws and

15 b) release the protective locking (6), fire the clips (3) and release them after the activation of the locking-firing mechanism (5) resulting to c) the stapling of the tissue.

Before the release of the stapled tissues by the opening of the head-jaws is performed the division of the tissue with a scalpel-blade in a special slot (4). 0 Alternatively, the blade may be incorporated between the rows of the clips so that the stapling and the division of the tissues may be performed simultaneously. 11) A surgical stapler of hollow organs as claimed in claim 10, comprises the occlusion mechanism of the jaws (10) which is situated in the distal part of the main shaft (7) and in the upper side of the trigger handles (9) which when 5 activated grasps and stabilizes the tissue between the heads-jaws (2), being also able to lock-unlock in order to correct any mistakes in the placement of the tissue. This step is the last one before the final firing of the clips (3), effected with the locking-firing mechanism (5) and after the removal of the protective cam wedge (safety) (6) between the locking-firing mechanism (5) and the trigger handles (9).