WO2006001040A1

WO2006001040A1 - Surgical forceps for forming purse string sutures

Info

Publication number: WO2006001040A1
Application number: PCT/IT2005/000336
Authority: WO
Inventors: Lorenzo Graziotti; Luciano Innocenti; Edoardo Scarcello; Massimo Bucefari
Original assignee: Elenor S.R.L.
Priority date: 2004-06-28
Filing date: 2005-06-14
Publication date: 2006-01-05
Also published as: ITFI20040147A1

Abstract

Surgical forceps for forming purse string sutures, which forceps comprise a first (1) and a second arm (2) with respective handling ends (1a, 2a) and operating ends. The two arms are slidingly connected one to the other with their longitudinal axes substantially parallel and a male gripping element (6) and a female gripping element (7) are respectively provided at their operative ends, one faced towards the other in an axial direction, suitable for taking in a fold of tissue (14) of the organ to which the suture has to be applied. The male element comprises at least one transverse ridge (6b), and the female element at least one transverse groove (7b), suitable for engaging mutually to take in the fold of tissue therebetween, whereby the latter takes on a wave-like configuration when the forceps are in the closure condition. The male element and the female element, once mutually engaged, define a passageway (11) perpendicularly to the ridge and to the transverse groove for the passage of a suture needle (12).

Description

TITLE SURGICAL FORCEPS FOR FORMING PURSE STRING SUTURES DESCRIPTION Field of the invention The present invention relates in general to the area of surgical instruments and, more particularly, relates to surgical forceps for forming purse string sutures. Description of the prior art As is known, the purse string suture is a type of suture used frequently during surgical operations. It is a continuous suture which, by way of an example, can be imagined as characterised in that the suture thread, passing through the tissue, defines a circle, whose diameter is gradually reduced with the fastering of the same suture thread up to a minimum limit obtained with complete tightening of the same thread. If we exclude cases wherein very narrow and/or deep areas of the body are concerned, the execution of this type of suture is relatively simple and fast. Purse string sutures can be applied manually or mechanically by means of dedicated instruments. The instruments for mechanical application of a purse string suture currently available on the market were essentially designed to close the end of a sectioned intestinal loop (broadly speaking, from the oesophagus as far as the rectum) . By assimilating the sectioned loop to a tube, the commercially available instruments were designed so as to take in the free end of said tube, bringing its walls together and allowing the passage of two separate needles, attached to the ends of the same suture thread, through the two separate walls brought together and taken in between the jaws of the instrument. These conventional devices all have the feature of being formed by a pair of flat jaws, positioned at the end of two arms hinged to each other at an intermediate point and with the opposite ends shaped like a ring acting as a grip. The tissue flaps, to which the suture has to be applied, are pinced between these jaws. When the jaws close, they flatten a roughly cylindrical structure, for example a section of the gastrointestinal system, and, in a closed position, define two channels wherein two needles carrying the suture thread, one for each of the two walls, are made to pass, each of the two needles being connected to one of the two free ends of a thread. During use, the tissue to be sutured is taken in between the jaws and the needles are passed by hand through the passages formed on both the jaws so as to attach the suture to the tissue. After which the jaws are opened and the suture is tightened to pull the tissue and bring the flaps thereof closer together. There are devices which do not require the manual passage of the needles, in that the thread of the purse string is integrated with the tissue by means of metal staples which are attached automatically at the time of closure of the jaws on the tissue. The introduction into the area of surgery of circular suturing devices which allow mechanical positioning of anastomosis has increased the rate of demand for purse string sutures which have thus become essential for the correct use of these circular suturing devices. By way of an example, a circular suturing device associated with a preliminary purse string suture is used in prolapsectomy operations according to Longo (A. Longo, Treatment of haemorrhoid disease by reduction of mucosa and haemorrhoid prolapse with a circular suturing device: a new procedure, (Proceedings of the 6th World Congress of Endoscopic Surgery, Rome, 3-6 June 1998, pages 777-84) . According to this surgical technique, haemorrhoid and mucosal prolapse is corrected by the excision of a transverse ring of prolapsed anal and/or rectal mucosa. A purse string suture is formed in the prolapsed mucosa through a fenestrated anoscope. A dedicated circular suturing device is then introduced in such a way that its abutment-head passes over the purse. The threads of the suture are then tautened so as to tighten the prolapsed mucosa whereto the suture has been applied around the small metal cylinder connecting the abutment-head and the staples-holder head. The free ends of the suture thread are then made to exit from special holes in the body of the suturing device. By pulling the ends of the suture threads, correct positioning of the prolapsed mucosa between the abutment-head and the staple-holder head of the suturing device is aided further. By actuating the circular suturing device, excision of the mucosal ring and formation of the suture are performed simultaneously. Creating a purse string suture in the narrow space forming the anorectal region is a particularly delicate step in the application of this surgical technique, which is highly interesting due to its speed of execution and the postoperative comfort guaranteed for the patient. This suture is currently performed totally by hand and is the least standardised among the operating steps of the surgical procedure. More particularly two aspects are frequently observed in the current method of forming this suture: a) the various sections into which the suture could be divided do not lie on a same plane perpendicular to the main axis of the anorectal tract, but are at different heights in relation to the haemorrhoid apex; b) the prolapsed mucosa is transfixed at different depths in relation to the mucosa surface and therefore the thickness of the tissue inserted in the suture is not constant. Given the growing diffusion of the Longo method, it is desirable that the performance of the purse string suture be simplified and standardised, avoiding the disadvantages indicated previously and ensuring that said purse string suture lies on a plane which is as perpendicular as possible to the anorectal axis, and that the thickness of the sutured tissue, previously established by the operator, is kept constant. Objects and summary of the invention The object of the present invention is to provide surgical forceps which allow the formation of a purse string suture simply and accurately, even when it has to be applied in deep and/or narrow areas of the body. A particular object of the present invention is to provide surgical forceps of the type mentioned above whose actuation is possible and easy also inside hollow internal organs or in anatomical areas currently not suitable for the use of commercially available suturing instruments wherein this type of suture has to be performed completely by hand. Another object of the present invention is to provide surgical forceps of the type mentioned above which, if made for repeated use, are easy to clean and sterilise in every part thereof, like many similar known devices. A further object of the present invention is to provide surgical forceps of the type mentioned above, which also allow execution of other types of suture, in particular intestinal anastomoses according to the Connel Stitch method. These objects are achieved with the surgical forceps for the formation of purse string sutures according to the present invention, whose main features are disclosed in claim 1. Substantially, the surgical forceps for forming purse string sutures according to the invention comprise a first and a second arm with respective handling ends and operating ends. The two arms are slidingly connected one to the other with their longitudinal axes substantially parallel and at their operating ends a male gripping element and a female gripping element are respectively provided, faced one towards the other in an axial direction and suitable for taking in a fold of tissue of the organ to which the suture has to be applied. The male element comprises at least one transverse ridge, the female element at least one transverse groove, suitable for mutually engaging so as to take in between them the fold of tissue, so that the latter takes on a wave-like shape when the forceps are in the closure condition. The male element and the female element, once mutually engaged, define a through channel perpendicular to the ridge and to the transverse groove for the passage of a suture needle. Brief description of the drawings Further features and/or advantages of the surgical forceps for the formation of purse string sutures according to the present invention will be made clearer by the following description of one of their embodiments, given by way of a non-limiting example, with reference to the accompanying drawings in which: - Figure 1 is a plan view of the surgical forceps according to the invention in a closed position; - Figure 2 is a plan view of the surgical forceps of Figure 1 in a disassembly position; Figure 3 is an enlarged view of the operating portion of the forceps according to the invention in an open position; Figure 4 is an enlarged view of the operating portion of the forceps according to the invention in a closed position and with a curved needle passing therethrough; Figure 5 is an enlarged perspective view illustrating the portion of connection of the two arms of the forceps according to the invention; - Figures 6 and 7 illustrate two successive phases of the formation of a fold of tissue by means of the forceps according to the invention; - Figure 8 illustrates schematically the development of the suture stitches which can be formed with the forceps according to the invention; - Figure 9 illustrates a variation of the forceps according to the invention, used for an intestinal anastomosis of the Connell Stitch type. Detailed description of the invention Referring to Figures 1 and 2, the forceps according to the invention comprise a pair of arms 1 and 2, each of which has a handling end or ring-shaped grip and denoted respectively by Ia and by 2a. The two arms 1 and 2 are slidingly connected one to the other in the direction of their longitudinal axes. For this purpose the arm 1 has along one of its intermediate sections a channel-shaped portion 3 wherein the other arm 2 engages. More particularly the latter has an enlarged intermediate portion 4 suitable for engaging slidingly, but not rotatingly, in the channel 3. To allow the sliding, but not the rotating, the sections of the channel 3 and of the enlarged portion 4 are for example made in a quadrilateral shape. The forceps according to the invention are advantageously provided with a retaining ratchet designed to maintain them in the closed condition. For this purpose a section of the enlarged portion 4 has a plurality of transverse ribs 4a, while along the arm 1 a tooth 5 is correspondingly provided, suitable for engaging selectively between two adjacent ribs 4a to lock the relative sliding of the arms of the forceps in the required closure position. The release can be caused easily by a very slight moving apart of the two arms to allow disengaging of the tooth 5 from the transverse ribs 4a. As shown in greater detail in Figures 3 and 4, the arms 1 and 2 end with respective operating gripping ends and in particular the arm 1 ends with a male element 6 formed by a flat head 6a with a ridge 6b extending transversely therefrom and a side arm 8 extending from the arm 2 , ending with a female element 7 placed in substantial axial alignment with the male element 6. The female element 7 is formed by a body 7a placed at the end of the side arm 8 and by a transverse groove 7b formed on the face of the body 7a faced towards the male element 6. The shape of the transverse ridge 6b is such that it engages in the transverse groove 7b when the male element 6 and the female element 7 are moved one towards the other following relative sliding of the two arms 1 and 2 of the forceps. A cavity 9 is formed in a median position on the ridge 6b and perpendicular thereto, while two corresponding cavities 10 are formed on the part of the body 7a defining the transverse groove 7b. In this way, when the transverse ridge 6b is engaged in the transverse groove 7b, the respective cavities 9 and 10 are aligned one with the other, thus defining a passageway 11 for the passage of a suture needle, even of the curved type, denoted by 12 in Figure 4. To allow the alignment of the male element 6 with the female element 7, the portion Ib of the arm 1 extending between the male element 6 and the channel 3 is slightly spred apart and divergent in relation to the sliding direction. The use of the surgical forceps according to the invention is illustrated in Figures 6 and 7. In these drawings 13 denotes the wall of a tubular organ, such as the rectum, and 14 a fold obtained by pulling the mucosa with traditional auxiliary forceps. The fold 14 is created between the male element 6 and the female element 7 of the forceps according to the invention in an open position, so that, by closing the forceps, the fold 14 remains inserted between them and in particular engaged in the transverse groove 7b of the female element 7 due to the thrust by the transverse ridge 6b of the male element . With the forceps closed the fold therefore takes on a wave-like configuration, shown in Figure 7, so that the suture needle 12, at each passage in the passageway 11, pass through the fold twice, forming with the thread 15 two suture stitches Sl and S2 at each passage, as shown in Figure 8. In this figure there is schematically shown how, with the forceps in the open condition, the suture thread -Si- is positioned once the fold is extended again. It will be seen that, unlike conventional purse string sutures, wherein the suture stitches pass through the mucosa perpendicularly in relation to the axial direction of the internal organ, in the case of the forceps according to the present invention the thread passes through the mucosa parallel to the axial direction. In other words, in the current state of the art, completely manual, the suture thread has to pass behind the prolapsed mucosa to be removed. With the use of the forceps according to the invention, as can be seen in Figures 7 and 8, the prolapsed mucosa is forced into "waves" through which the thread is passed. When the forceps release the wave and the mucosa is relaxed, the thread is seen to pass through the mucosa following a path parallel to the main axis of the internal organ. The advantages of this mode of operation are that the quantity of mucosa which is engaged in the suturing device used in the Longo technique is greater while maintaining the number of sutures equal and that the control of the formation of the suture is enormously simpler. The forceps according to the invention is easily disassemblable, it being sufficient for this purpose to make the entire enlarged portion 4 of the arm 2 slide outside of the channel 3, as shown in Figure 2, and pass the thinner part thereof through an aperture 3a in the channel 3, in order to separate the two arms so as to be able to clean them adequately, should the forceps be of the reusable type. It is clear however that the forceps according to the invention may also be made in a disposable version. The aperture 3a in the channel 3 will have sufficient width to prevent withdrawal of the arm 2 when its enlarged portion 4 is engaged therein; this width will however be greater than the section of the non- enlarged part of the arm 2 so as to allow separation thereof for cleaning. By making the male element 6 with several parallel transverse ridges 6b and correspondingly the female element 7 with several parallel transverse grooves 7b, it is possible to increase the number of passages of the needle through the mucosa and therefore the number of suture stitches which can be formed at each passage. Clearly, a solution of this kind that entails larger dimensions of the male element and of the female element of the forceps may only be adopted where permitted by the dimensions of the internal organ wherein it is necessary to operate. By means of a single passage of the needle through the guide channel 11 it is therefore possible to suture a quantity of tissue proportional to the number of waves formed in the fold. By repeating this operation a sufficient number of times, a purse string suture is formed with ease. From what is described above, it is clear that the surgical forceps according to the invention allow the set objectives to be reached. More particularly: a) use of the forceps is possible even inside the lumen of the internal organs; b) it is possible to suture tissues with extremely reduced thickness; c) the fold taken in between the male element and the female element of the forceps, irrespective of the number of waves created thereon, is subjected to a constant pressure, evenly distributed and of such an extent as to allow use thereof even on very delicate tissues or tissue made delicate by intercurrent diseases or therapeutic treatments; d) the suture is formed constantly through the entire width of the tissue inserted in the operative zone, which makes its formation particularly accurate and effective, e) it is possible to form purse string sutures that are useful not only for the formation of end-to-end anastomoses, but also end-to-side and side-to-side ones. Although the surgical forceps according to the invention can be used for the formation of purse string sutures in all the conditions wherein they are required, they are particularly useful in transanal mucosal prolapsectomy according to Longo's surgical technique. The use of the forceps according to the invention allows to define with greater accuracy, as compared to the current methods, the thickness of the folds of tissue inserted in the purse string suture and above all to maintain such thickness constant for the entire suture. The suture passes through the tissue folds at a distance from the free edge of the fold which is fixed by the operator, ensuring constant tissue insertion along the whole circumference of the internal organ. Moreover the use of the forceps according to the invention for the formation of the purse string suture allows this suture to be formed at a distance in relation to the haemorrhoid apex which the operator can easily establish and maintain constant for the whole circumference of the internal organ. The forceps according to the invention can also be advantageously used for forming intestinal anastomoses according to the Connell Stitch method. According to this technique, the suture thread passes from the serosa towards the interior of the visceral lumen through all the layers of the wall of the intestinal segment to be anastomised and then projects by passing once again through all the layers of the wall of the same intestinal segment, with a reverse path at an appropriate distance from the previous entrance point . The thread at this point is moved to suture the other intestinal segment in the same way and the operation is repeated alternatively until the anastomosis of the two abutting segments is completed. By appropriately tightening the two ends of the suture thread, the anastomosis is formed by means of an introflecting suture which places the serous surfaces of the internal organs perfectly adjacent. Figure 9 schematically shows two sections of intestine 101 and 102 to be anastomised, end-to-end, for example. By using the forceps according to the invention as shown in the drawing, the double transfixing of the needle in a single passage is achieved. By pinching the end part of the intestine between the jaws 6 and 7 of the forceps, a loop 105 is formed which is passed through by the needle 12 guided in the cavity 10 of the female element 7. By opening the forceps the intestinal wall extends, allowing the suturing thread 103 to position as in point 104 (the dotted part of the thread is inside the intestinal tract) . By applying the forceps alternatively in the section 101 and in the section 102 of the intestine, the suturing can be completed with the following advantages in relation to the non-assisted method: - the pitch between the entrance hole and the exit hole for each stitch is constant, in that determined by the geometry of the forceps; at each passage of the needle both entrance transfixing and exit transfixing are performed; - suture formation is faster and definitely easier, above all considering the fact that in general it is necessary to operate in small spaces. It should be noted that, in order to increase manoeuvrability of the forceps, preventing them from rotating during opening and closure, the arm 1, which in this case holds the female element I₁ is provided with a double ring handling end 101a for the insertion of two fingers. Variations and/or modifications may be made to the surgical forceps for the formation of purse string sutures according to the present invention, without thereby departing from the spirit and scope of the same invention as set forth in the following claims.

Claims

CLAIMS 1. Surgical forceps for forming purse string sutures comprising a first (1) and a second (2) arm with respective handling ends (Ia, 2a) and operating ends, characterised in that said first and said second arm are slidingly connected relative to each other with their longitudinal axes substantially parallel, a male gripping element (6) and a female gripping element (7) being respectively provided at the operating ends of said arms faced one towards the other in an axial direction and suitable for taking in a fold (14) of tissue of the organ to which said suture has to be applied, the male element comprising at least one transverse ridge (6b) , the female element at least one transverse groove (7b), suitable for mutually engaging to take in said fold of tissue between them, so that the latter assumes a wave-like configuration when said forceps are in the closure condition, said male element and said female element, once mutually engaged, defining a passangeway (11) perpendicularly to said at least one ridge and said at least one transverse groove for the passage of a suture needle (12) . 2. Surgical forceps according to claim 1, wherein said male gripping element (6) and said female gripping element (7) are laterally displaced in relation to the axial sliding direction of said arms (1, 2) . 3. Surgical forceps according to claims 1 or 2, wherein one of said arms (2) has at its operating end a side arm (8) to which said male element (6) /female element (7) is attached, the other of said arms (1) diverging substantially in relation to its longitudinal axis to align axially the female element (7) /male element (6) placed at its end with the respective male element (6) /female element (7) placed at the end of the other arm (2) . 4. Surgical forceps according to any one of the previous claims, wherein on said transverse ridge (6b) of said male element (6) an intermediate cavity (9) is formed, corresponding cavities (10) being formed transversally to said transverse groove (7b) , so that when said ridge is engaged in said groove, said cavities are aligned to form said passageway (11) for the suture needle (12) . 5. Surgical forceps according to any one of the previous claims, wherein said first arm (1) has an axial intermediate channel-shaped portion (3) , suitable for housing slidingly, but not rotatingly, a corresponding sliding portion (4) of said second arm (2) . 6. Surgical forceps according to any one of the previous claims, wherein said second arm (2) has an enlarged section at said sliding portion (4) . 7. Surgical forceps according to any one of the previous claims, wherein said sliding portion (4) and said channel- shaped portion (3) have a quadrilateral section. 8. Surgical forceps according to any one of the previous claims, wherein along said first and said second arm a retaining ratchet (4a, 5) is provided, for maintaining the forceps in a closed condition. 9. Surgical forceps according to claim 8, wherein said retaining ratchet comprises a tooth (5) projecting transversely from one of said arms (1) and a portion with transverse ribs (4a) which is formed correspondingly on the other arm (2) , said tooth being suitable for engaging between two adjacent ribs to prevent the free relative sliding of said arms. 10. Surgical forceps according to any one of the previous claims, wherein said channel-shaped portion (3) is open laterally, the relative aperture (3a) having a width smaller than said sliding portion (4) and greater than the section of said arm (2) near its handling end (2a) , whereby said arms can be separated one from the other following relative sliding until bringing said portion with reduced section to said aperture (3a) . 11. Surgical forceps according to any one of the previous claims, which can also be used for forming intestinal anastomoses of the Connell Stitch type.