WO2015143477A1

WO2015143477A1 - Continuous subcuticular suturing apparatus and method

Info

Publication number: WO2015143477A1
Application number: PCT/AU2015/000166
Authority: WO
Inventors: Comus WHALAN; Jonathan Ben-Tovim
Original assignee: Whalan Comus
Priority date: 2014-03-24
Filing date: 2015-03-23
Publication date: 2015-10-01

Abstract

The present invention relates to a skin suturing apparatus (10) for suturing together first and second longitudinal sides of an incision. The apparatus (10) includes a first locating member (20) for locating a part of a first side of the incision and a second locating member (40) for locating a part of a second side of the incision. The first and second locating members (20, 40) are configured to locate the parts of the first and second sides of the incision so that an imaginary closure line (CL) extends through said located parts. The skin suturing apparatus (10) further includes a needle receiving aperture (62) with a longitudinal axis generally coincident with the imaginary closure line (CL) through which a needle (150) may be passed. The present invention also relates to a method of suturing a wound or an incision using such a skin suturing apparatus (10).

Description

Continuous Subcuticular Suturing Apparatus and Method

Related Application

[0001] This application is related to Australian provisional patent application 2014901038 filed on 24 March 2014, the entire contents of which are incorporated herein by reference.

Technical Field

[0002] The present invention relates to a skin suturing apparatus and method. The apparatus and method have particular, but not exclusive application, in suturing large incisions.

Background of Invention

[0003] Most surgical operations involve incisions in the patient's skin, which must later be closed. There are several methods of closing skin incisions, each with their own advantages and disadvantages. One of the most common methods is known as the subcuticular suture. In accordance with this method, the surgeon inserts a single piece of suture material just below the surface level of the skin, alternating from one side of the incision to the other in a zigzag fashion.

[0004] Subcuticular suturing has several advantages over other skin closure methods. Firstly, it typically produces a scar that is cosmetically excellent and secondly, when absorbable suture material is used, it avoids the need to remove the suture later. A disadvantage of subcuticular suturing is that it is surprisingly time consuming to undertake. For example, a standard Caesarean section wound (typically 15-18 cm long) takes a median 8.5 minutes to close, compared to a staple closure [Tuuli MG, Rampersad RM, Carbone JF et al. Staples Compared with Subcuticular Suture for Skin Closure after Cesarean Delivery. A Systematic Review and Meta-analysis. Obstet Gynecol 201 1 ;117:682-90]. [0005] A less experienced surgeon will take even longer to complete the same closure. Other operations such as an abdominoplasty require incisions over 60cm long and sometimes up to 90cm long.

[0006] It is extremely desirable to minimise surgical time for a variety of different reasons. Firstly, the costs of running an operating room are very high, so it is important to be able to move patients through the room as efficiently as possible. The exact costs of running an operating room vary depending on the method of calculation used. However, a recent randomised prospective study of skin closure methods in hip fracture surgery, compared skin staples to subcuticular suturing (then sealing the wound with glue). That study found that although subcuticular suturing was better than staples for the wound outcomes measured, the cost per patient "was

approximately USD900 greater on average (in the subcuticular group) due to increased time in the operating room required for the subcuticular closure" [Mudd CD, Boudreau JA, Moed BR. A prospective randomised comparison of two skin closure techniques in acetabular fracture surgery. J Orthop Traumatol 2014 Sep; 15(3):181 - 94].

[0007] Secondly, if the patient is particularly unwell, it is very desirable to finish the surgery and move the patient to the Intensive Care Unit for stabilisation as soon as possible. Also, surgeons and anaesthetists are often extremely busy and thus desire to complete each surgery as soon as possible, enabling them to move onto the next patient on their operating list.

[0008] As subcuticular suturing is so time consuming, surgeons will commonly use other methods of skin closure, such as staples or glue. These methods have their own disadvantages. For example, although staples are clearly faster, two recent meta-analyses covering different fields of surgery, have both shown that staples have a two to four-fold higher rate of wound infection, while one also showed a two-fold higher rate of the wound falling apart (dehiscence) [Tuuli MG, Rampersad RM, Carbone JF et al. Staples compared with subcuticular suture for skin closure after cesarean delivery: a systematic review and meta-analysis. Obstet Gynecol 201 1 Mar; 1 17(3):682-90); Smith TO, Sexton D, Mann C, Donell S. Sutures versus staples for skin closure in orthopaedic surgery: meta-analysis. BMJ 2010 Mar 16;340:c1199]. [0009] Staples must later be removed from the healing wound and this process is uncomfortable if not quite painful for many patients. It also requires special staple- removal equipment and involvement by a doctor or nurse, all adding to the cost of the overall procedure.

[0010] Staple removal must occur post-operatively at the correct time. This is because staples allow healing skin cells to migrate along them, leaving a permanent and unsightly cross-hatched scar if the staples are left in too long. On the other hand, if the staples are removed too soon, prior to the wound healing properly, the wound will fall apart. Even when the staples are removed at the correct time, for months afterwards the scar from a stapled wound is "ugly" compared to that formed when subcuticular sutures are used.

[0011] Tissue glues have been used in an attempt to overcome the problems discussed above. However, studies show significantly higher rates of wound dehiscence when glue is used as the closure method [Coulthard P, Esposito M, Worthington HV at al. Tissue adhesives for closure of surgical incisions. Cochrane Database Syst Rev. 2010 May 12;(5):CD004287]. Accordingly, despite the

availability of surgical glues since the 1970s they have failed to achieve widespread use for surgical wounds.

[0012] The present invention seeks to provide a skin suturing apparatus and related method.

[0013] The discussion of the background to the invention herein is included to explain the context of the invention. This is not to be taken as an admission that any of the material referred to was published, known or part of the common general knowledge as at the priority date of this application.

Summary of Invention

[0014] According to a first aspect of the present invention there is provided a cutaneous suturing apparatus for suturing together first and second longitudinal sides of an incision, said apparatus including a first locating member for locating a part of a first side of the incision, a second locating member for locating a part of a second side of the incision, and wherein the first and second locating members are configured to locate the parts of the first and second sides of the incision so that an imaginary closure line extends through said located parts.

[0015] The apparatus further preferably includes a needle receiving aperture with a longitudinal axis generally coincident with the imaginary closure line through which a needle may be passed, said needle being arranged to be passed generally along the imaginary closure line so that a suture secured to the needle can be pulled along the imaginary closure line and thereafter used to hold the first and second longitudinal sides of the incision together.

[0016] Preferably, the apparatus includes a plurality of first locating members and a plurality of second locating members. The plurality of first locating members are connected together to form a row of first locating members and the plurality of second locating members are connected together to form a row of second locating members.

[0017] In accordance with a preferred embodiment of the invention, the plurality of first locating members are arranged to be connected together by mounting on a first shaft and the plurality of second locating members are arranged to be connected together by mounting on a second shaft. In use, the first and second shafts extend generally parallel to one another and generally parallel to the first and second longitudinal sides of the incision.

[0018] The number of first and second locating members mounted on each shaft will vary preferably depending on the length of the incision to be sutured. It should be appreciated that it is desirable for the surgeon to be able to readily increase or decrease the number of first and second locating members included in the apparatus to accommodate different incision lengths

[0019] Adjacent first locating members on the shaft are preferably connected together to prevent relative movement there between. A male/female detent type connection may be provided for this purpose. The connection is preferably such that the locating members can be easily connected and disconnected. A snap on, snap off type connection would be advantageous.

[0020] Each of the first and second locating members includes a body and means for engaging with skin so that the engaged skin can thereafter be located so that the imaginary closure line extends through the located skin. The locating members on each side of the wound are preferably operated in such a way that they can be used to draw the wound into a zig-zag shape. A needle with attached suture material is then passed along the imaginary closure line of the apparatus and passed out of the skin so that the surgeon can grasp the suture material. The apparatus is then removed carefully from the wound. The suture material will then lie in a generally zigzag manner within the sutured skin. It will be appreciated that the "zig-zag"

configuration of the suture material adopts a series of generally smooth curves or a series of "S" shapes, rather than strictly straight lines of a conventional zig-zag pattern.

[0021] In accordance with one embodiment of the invention, the engaging means includes a hook having a generally "C" shape. However the use of other shapes and configurations are envisaged, for example a "U" shape could be adopted.

[0022] A holding peg is preferably associated with each of the first and second locating members. Each peg being arranged to facilitate holding of tissue in a required position once the hook of the associated locating member has been engaged with the skin.

[0023] The hook is preferably arranged to be placed in the patient's subcutaneous tissue immediately deep to and abutting the deep layer of the skin (the dermis). The hook is then locked in place on the skin by pushing the peg down onto the outer surface of the skin. The skin is thereby firmly held between the hook and the holding peg.

[0024] In accordance with a preferred embodiment, each peg is arranged for sliding engagement relative to the associated locating member. Preferably, the locating member includes an elongate aperture through which the peg may be slid. The aperture in the locating member and the peg are preferably configured so that the peg may be held in a required position against the tissue whilst suturing occurs.

[0025] The apparatus further preferably includes first and second end units. The first and second end units being arranged to secure the row of first locating members and the row of second locating members together and in such a position that the parts of the first and second sides of the incision held by the first and second locating members are located and held so that the imaginary closure line extends through said located parts.

[0026] The inner end unit preferably incorporates the needle receiving aperture.

[0027] The inner end unit is further preferably arranged for connection with a needle cartridge.

[0028] According to a preferred embodiment of the invention and during use of the apparatus, the hooks of the first and second locating members whilst holding parts of the skin are moved to an operative suturing position. In the operative suturing position, the hooks extending from the first locating members are interlaced between the hooks extending from the second locating members. The distance the hooks are interlaced in a direction perpendicular to the length of the shafts is a distance sufficient to ensure that the parts of the tissue held by the interlaced hooks are also similarly interlaced and so that those parts cross over different sides of the imaginary closure line CL. This results in the tissue being interlaced in a zigzag type fashion in the same sort of manner required for conventional skin suturing.

[0029] In a second aspect the invention provides a method of forming a

continuous subcuticular suture. The method preferably uses a cutaneous suturing apparatus according to the first aspect of the invention.

[0030] The method preferably includes the steps of: a) hooking tissue of a part of a first side of a wound or an incision with a first hook; b) hooking tissue of a part of a second side of an incision with a second hook; c) moving the first and the second hooks so that the parts of the first and second sides of the incision are located so that an imaginary closure line extends through said located parts; and d) passing a needle generally coincident with the imaginary closure line and through the parts so that a suture secured to the needle can be pulled along the imaginary closure line and thereafter grasped by the surgeon. [0031] In accordance with a preferred embodiment of the method, the first hook includes a plurality of first hooks and each of the first hooks are arranged to hook an associated part of the first side. The second hook includes a plurality of second hooks and each of the second hooks are arranged to hook an associated part of the second side.

[0032] The method further preferably includes the steps of: e) removing the hooks from the tissue; and f) tensioning the suture to close the incision.

[0033] The step of removing the hooks from the tissue preferably further includes removing the hooks from the suture material.

[0034] Still further the method preferably includes the steps of: g) securing the suture to close the incision. Brief Description of Drawings

[0035] Embodiments of the invention will now be described, by way of example only, with reference to the accompanying drawings in which:

[0036] Figure 1 is an isometric view of a cutaneous suturing apparatus according to an embodiment of the invention;

[0037] Figure 2 is a top view of the apparatus shown in Figure 1 ;

[0038] Figure 3 is an underneath view of the apparatus shown in Figure 1 ;

[0039] Figure 4 is a side view of the apparatus shown in Figure 1 ;

[0040] Figure 5 is another isometric view of the apparatus shown in Figure 1 but with the needle assembly removed;

[0041] Figure 6 is a view similar to Figure 5 but with the inner end unit shown removed and the inner most first locating member (with associated peg) shown removed from the left side shaft; [0042] Figures 7A, 7B, 7C, 7D and 7E are respective front, side, back, top and isometric views of the inner end unit;

[0043] Figures 8A, 8B, 8C, 8D, 8E, 8F and 8G are respective isometric, front, right, back, top, left and bottom views of one of first locating members;

[0044] Figures 9A, 9B, 9C, 9D and 9E are respective isometric, front, top, left and bottom views of one of the pegs;

[0045] Figures 10A, 10B, 10C, 10D and 10E are respective front, side, back, top and isometric views of the outer end unit;

[0046] Figure 1 1 is an isometric view of the needle cartridge with needle launcher. The needle is not shown;

[0047] Figure 12 is a rear view of the needle launcher shown in Figure 1 1 ;

[0048] Figure 13 is an end view of the cartridge, launcher and needle; and

[0049] Figure 14 is an enlarged underside isometric view showing the needle as it is being passed through the suturing apparatus.

Detailed Description

[0050] Figures 1 to 4 illustrates a cutaneous suturing apparatus 10 according to an embodiment of the invention. The apparatus 10 is shown with a needle cartridge 100 and needle 150 attached thereto.

[0051] Figure 5 illustrates the cutaneous suturing apparatus 10. The apparatus 10 includes a first locating member 20 for locating a part of a first side of an incision, a second locating member 40 for locating a part of a second side of the incision. As will be explained in more detail subsequently, the first and second locating members 20, 40 are configured to locate the parts of the first and second sides of the incision so that an imaginary closure line CL extends through said located parts. The apparatus 10 further includes a needle receiving aperture 62 with a longitudinal axis generally coincident with the imaginary closure line CL (Figures 4 and 5) through which a needle 150 may be passed. The needle 150 being arranged to be passed generally along the imaginary closure line CL so that a suture (not shown) secured to the needle 150 can be pulled along the imaginary line and thereafter used to hold the first and second longitudinal sides of the incision together. A full description of the method of use of the skin suturing apparatus 10 to close an incision is set out following the below description of the components of the apparatus 10.

[0052] As shown in Figure 5, the apparatus 10 includes a plurality of first locating members 20 and a plurality of second locating members 40. Indeed, fifteen first and fifteen second locating members 20, 40 are illustrated but more or less such members 20, 40 may be included depending on the size of the incision being sutured. It is recommended that one first locating member 20 be provided for approximately each 20mm of incision and that a similar number of second locating members 40 also be provided. Accordingly, one locating member is actually provided for approximately every 10mm of wound.

[0053] As best shown by Figure 6, the plurality of first locating members 20 are arranged to be connected together by mounting on a first shaft 50a. The plurality of second locating members 40 are arranged to be connected together by mounting on a second shaft 50b. Figure 6 depicts the inner end cap 60 removed from the inner most first and second locating members 20, 40 and the inner most first locating member 20 removed from the first shaft 50a. It will thus be appreciated that the apparatus 10 includes a row of first locating members 20 and a row of second locating members 40 mounted on their respective shafts 50a, 50b. In use, the first and second shafts 50a, 50b extend generally parallel to one another and generally parallel to the first and second sides of the incisions.

[0054] It should be appreciated that by increasing the length of each of the shafts 50a, 50b and the number of first and second locating members 20, 40 mounted respectively there along, the apparatus 10 can be used to suture different sized lengths of incision. It is envisaged that in an operating theatre, a surgeon may have the option of selecting either a small, medium or large suturing apparatus according to an embodiment of the invention. Once either a small, medium or large suturing apparatus has been selected, the surgeon then has the ability, as will be described later, to further adjust the apparatus 10 by varying the number of first and second locating members 20, 40 so that it is suitable for use with the particular incision to be closed. [0055] The first and second locating members 20, 40 are retained on their respective shafts 50a, 50b and the shafts 50a, 50b, are located generally parallel to one another by means of an inner and an outer end unit 60, 70. In accordance with the illustrated embodiment, the inner end unit 60 is arranged to be connected to the needle cartridge 100 and to the inner most first and second locating members 20, 40. The outer end unit 70 is arranged to be connected to the outer most first and second locating members 20, 40.

[0056] Adjacent first locating members 20 located on the first shaft 50a are arranged to be connected together to prevent relative movement there between. It is desirable to prevent relative movement between the first locating members 20 so that they can be operated in unison (i.e. as a row), making the step of hooking the parts of one side of the incision more efficient and minimising the likelihood that a part of that side of the incision may be inadvertently unhooked.

[0057] The connected first locating members 20 are preferably arranged, in accordance with one arrangement, so that at least a small amount of rotation of the row of first locating members 20 is possible relative to the first shaft 50a. Similarly, the second locating members 40 located on the second shaft 50b are arranged to be connected together to prevent relative movement there between. The connected second locating members 40 are preferably arranged so that at least a small amount of rotation of the row of second locating members 40 is possible relative to the second shaft 50b. This rotational movement allows the angle of the rows of first and second locating members 20, 40 to be adjusted by the surgeon even after the inner and outer end units 60, 70 are connected to the shafts 50a, 50b and the inner and outer most first and second locating members 20, 40. It will of course be appreciated that any rotation of such parts must be constrained so that the path for the needle 150 remains straight.

[0058] Figures 7A to 7E illustrate the inner end unit 60. As shown, the inner end unit 60 includes the needle receiving aperture 62. Needle receiving aperture 62 is located in a needle hanger 63 that hangs away from the main body 64 of the inner end unit 60. This locates the needle receiving aperture 62 in the required position so that when the needle 150 is passed there through it will be pushed through the skin to be sutured. [0059] The main body 64 of the inner end unit 60 includes a pair of apertures 66 for receiving the shafts 50a, 50b and part of the respective inner most first and second locating members 20, 40 mounted on the shafts 50a, 50b. A detent type male/female connection is provided in use between the inner most first and second locating members 20, 40 and the inner end unit 60. To this end, the inner end unit 60 includes a pair of female members 68 arranged to receive respective male members 22, 42 of the inner most first and second locating members 20, 40. Each female member 68 is formed as a U-shaped loop 68. The connection between the inner end unit 60 and the inner most first and second locating members 20, 40 will become apparent from later description.

[0060] The first and second locating members 20, 40 are mirror images of one another. Accordingly, only the configuration of one of the first locating members 20 will be described in further detail.

[0061] Figures 8A to 8G depict the first locating member 20. The first locating member 20 includes a main body 22, a foot 23 and a leg 24. In use, when a needle is being passed through the apparatus 10 (as will be explained in detail below), the foot 23 of each locating member 20, 40 rests on or close to the patient's skin adjacent to the incision.

[0062] Extending from the leg 24 is a hook 25. On the side of the main body 22 opposite to the leg 24 is a male member 26 and a female member 28. Male member 26 is a resilient tongue 26 with a stepped projection 26a formed thereon. Female member 28 is a generally U-shaped loop 28 configured to receive a least a part of the resilient tongue 26 of an adjacent first locating member 20.

[0063] The main body 22 includes a bore 22a extending there through configured so that the locating member 20 can be mounted on the shaft 50a and so that the first locating member 20 has at least limited ability to rotate about the shaft 50a. The main body 22 is stepped so that it includes a first part 22b of first dimension and a second part 22c of a second dimension that is greater than the first dimension. The first part 22b, which forms a male part, is arranged to be receivable, at least in part, within the bore 22a of a second part 22c of an adjacent locating member 20. As the first part 22b is pushed into the second part 22c of the adjacent locating member 20, the tongue 26 is forced inwardly towards the main body 22. This deflection of the tongue 26 increases as the tongue 26 moves into the U-shaped loop 28 on the adjacent locating member 20 driving angled part 26a' of the stepped projection 26a against the U-shaped loop 28. The tongue 26 deflects inwardly until first part 22b is located within the second part 22c of the adjacent locating member 20. At which time, the angled part 26a' of the tongue 26 is received within the U-shaped loop 28 and an upright part 26a" engages against the loop 28 as the bias of the tongue 26 serves to return the tongue 26 to its original position. It will thus be appreciated that the tongue 26 acts as a detent against the U-shaped loop 28 of the adjacent (and now

connected) locating member 20 preventing inadvertent release of the two adjacent locating members 20.

[0064] Figure 8B best illustrates the leg 24 and hook 25 of the locating member 20. The hook 25 establishes a means for engaging skin tissue and is illustrated as having a generally "C" shape. The hook 25 may adopt different forms or shapes provided it can be engaged by the surgeon into the patient's tissue and be effective to pull the tissue into the required position for suturing during use of the apparatus 10. The hook 25 must also be configured so that the needle 150 can be passed through a part of the tissue held by the hook 25 or passed through tissue adjacent to the part of the tissue actually held by the hook 25. The tissue through which the needle 150 is passed must be positioned in an "operative suturing position" as will be explained in more detail below. To this end and as illustrated, each hook 25 includes a needle receiving aperture 25a formed centrally therewithin. However, the needle receiving aperture 25a need not be so located. For example the needle receiving aperture may be, for example, a loop or the like attached to the hook 25.

[0065] In one arrangement, each hook 25 includes an aperture for receiving the needle 150. The aperture is preferably funnel shaped with the larger diameter on the inlet side and the smaller diameter on the outlet side. This shape ensures that even if the needle 150 is not presented to the aperture exactly centred, it will be guided into the aperture and out of the outlet because of the funnel like shape.

[0066] Figures 8F and 8G illustrate a peg receiving aperture 29 formed in the leg 24 of the locating member 20. The aperture 29 has an upper end 29a and a lower end 29b and extends at an angle to the vertical through the leg 24. The peg receiving aperture 29 is arranged to receive a peg 80 arranged to facilitate holding of tissue in a required position once the hook 25 of the associated locating member 20, 40 has been engaged with the skin tissue. The operation of each peg 80 will be described in more detail later.

[0067] Figures 9A to 9D illustrate the peg 80. Peg 80 includes a barrel 82 configured, in use, to be received within the peg receiving aperture 29 of the associated locating member 20, 40. Barrel 82 divides into two parts 84a, 84b at its upper most end separated by an aperture. The first part 84a includes engagement steps 86 (Figure 9B) on an underside thereof. The engagement steps 86 are arranged to engage with complementary steps 29c formed in the upper end 29a of the aperture 29 thereby establishing a ratchet type mechanism. The first part 84a of the barrel 82 joins to a planar first engagement part 88a. The second part 84b of the barrel 82 of the peg 80 joins to second engagement part 88b. It should be understood that if the peg 80 is held so that the user's thumb engages with the curved edge of the first engagement part 88a and their index finger engages with the flat edge of the second engagement part 88b, squeezing together of the thumb and finger will cause the first part 88a to move towards the second part 88b. It is by this mechanism that the peg 80 can be locked and then released from the required position within the peg receiving aperture 29 of the leg 24. The arrow (Figure 9D) included on the first engagement part 88a indicates the required direction of movement of the first part 84a to achieve release of the peg 80 from the aperture 29 in the leg 24 of the locating member 20.

[0068] The lower most end of the barrel 82 includes serrations 84c designed to facilitate holding of the patient's skin by the peg 80 during use.

[0069] Figures 10A to 10D illustrate the outer end unit 70. As shown, the outer end unit 70 includes a needle receiving aperture 72. Needle receiving aperture 72 is located in a needle hanger 73 that hangs from a main body 74 of the outer end unit 70. In this way the needle receiving aperture 72 is located so that in use, the axis of the needle receiving aperture 72 is coaxial with the axis of the needle receiving aperture 62 of the inner end unit 60 and coaxial with the imaginary closure line CL. [0070] The main body 74 of the outer end unit 70 includes a pair of apertures 76 for receiving the shafts 50a, 50b and part of the respective outer most first and second locating members 20, 40 mounted thereon. A detent type male/female connection is provided between the outer most first and second locating members 20, 40 and the outer end unit 70. To this end, the outer end unit 70 includes a pair of tongues 78 arranged to be received within the U-shaped loops 28, 48 of the

outermost first and second locating members 20, 40. The connection between the outer end unit 70 and the outer most first and second locating members 20, 40 is similar to that between the inner end unit 60 and the inner most first and second locating members 20, 40.

[0071] Figure 1 1 illustrates the components of the needle cartridge 100. The needle cartridge 100 includes a case 1 10 and a launcher 120. The case 1 10 includes an elongate track 1 12 that extends along the length thereof and is arranged to receive the needle 150 and to allow the needle 150 to be driven there along by the launcher 120.

[0072] Figure 12 best illustrates the configuration of the needle launcher 120 and the aperture 122 formed therein. Depending into that aperture 122 is a tongue 124 with a needle receiving clip 126 formed at the free end. The aperture 122 is shaped so that the launcher 120 can be slid over the exterior of the needle case 110, with the tongue 124 located within the elongate track 1 12 of the needle case 1 10.

[0073] The needle 150 is arranged to be located in the needle case 110 and to be connected to the launcher 120 via the needle receiving clip 126. When the launcher 120 is slid along the length of the needle case 1 10, the needle 150 will also be caused to move along the length of the track 1 12. A suture (not shown) connected to the needle 150 will thus also be pulled along and through the length of the track 1 12. Figure 13 is an end view showing the launcher 120 mounted on the needle case 1 10 and with the needle 150 connected to the needle receiving clip 126 of the launcher 120.

[0074] As best understood by examination of Figures 4, 5, 11 and 13, the needle case 1 10 has a tip 1 13 configured to engage in the needle receiving aperture 62 of the inner end unit 60. The tip 1 13 engages in the needle receiving aperture 62 so that the needle cartridge 100 can be firmly connected to the cutaneous suturing apparatus 10. When the needle cartridge 100 is engaged with the cutaneous suturing apparatus 10, movement of the launcher 120 along the length of the track 1 12 to the position shown in Figure 4, will cause the needle 150 to be moved through apparatus 10 along a line generally coincident with the imaginary closure line CL and until the tip 152 of the needle 150 is exposed (Figure 4) at the outer most side (i.e. the side adjacent the outer end unit 70) of the apparatus 10.

[0075] The cutaneous suturing apparatus 10 is particularly suited to enable quick closure of an elongate incision. An exemplary method the surgeon takes to close an incision using an apparatus according to an embodiment of the invention will now be described with reference to the apparatus 10 described above. A method according to an embodiment of the invention is as follows:

1 . The surgeon selects an apparatus 10 with a length of shaft 50a, 50b at least about the same or slightly greater than the length of the incision.

2. The inner and outer end units 60, 70 are then disengaged from the shafts 50a, 50b of the apparatus 10 and put to one side for later use. Alternatively, the apparatus 10 may be provided to the surgeon with the inner and outer end units 60, 70 already separated from the shafts 50a, 50b.

3. The surgeon then takes the first shaft 50a with a plurality of first locating

members 20 positioned thereon and checks that the number of first locating members 20 is correct for the size of the incision to be closed. More

particularly, the surgeon needs to ensure that there are sufficient hooks 25 to engage parts of the skin along the full length of one side of the incision. This may require the surgeon to remove from or to apply to one or more first locating members 20 from the shaft 50a. Once so satisfied, the surgeon identifies the number of first locating members 20 on the first shaft 50a and ensures that the same number of second locating members 40 is mounted on the second shaft 50b.

4. The surgeon then takes the first shaft 50a with the row of first locating

members 20 positioned thereon and engages the hooks 25 of each of the first locating members 20 into the skin of the first side of the incision. The pegs 80 of each of the first locating members 20 are then applied by pushing them down into their respective peg receiving aperture 29 until the engagement steps 86 engage against the complementary steps 29c in the aperture 29. In use, the surgeon simply positions the hooks 25 correctly in the skin, then pushes down on the pegs 80. This action traps the skin between the respective peg 80 and hook 25, and the ratchet mechanism of the peg 80 and aperture 29 locks it in place. Squeezing 88a and 88b together releases the ratchet mechanism so that the skin can be freed from the apparatus 10 after suturing has taken place. It also allows the hooks 25 to be readjusted if necessary, prior to suturing. The surgeon then takes the second shaft 50b with the row of second locating members 40 positioned thereon and engages the hooks 25 of each of the second locating members 40 into the skin of the second side of the incision. The pegs 80 of each of the second locating members 40 are then applied by pushing them down into their respective peg receiving aperture 29 until the engagement steps 86 engage against the complementary steps 29c in the aperture 29 and the skin is held in place between the pegs 80 and the hooks 25. The surgeon then connects the inner and outer end units 60, 70 to the inner and outer ends of the shafts 50a, 50b (whilst ensuring that the hooks 25 remain engaged in the skin) and to the inner and outermost first and second locating members 20, 40 resulting in the assembled apparatus 10 as per Figure 5. Needle cartridge 100 is then connected to the apparatus 10 by engaging the tip 1 13 of the needle case 1 10 into the needle receiving aperture 62 of the inner end unit 60. Alternatively, the needle cartridge 100 may be supplied already attached. Launcher 120 is then slid along the needle case 1 10 until it reaches the position shown in Figure 4. When the launcher 120 reaches the position shown in Figure 4, the tip 152 of the needle 150 can be grasped by the surgeon and pulled away from the apparatus 10. The needle 150 is pulled until suture is exposed and a length of suture is available to the surgeon.

1 1 .The surgeon then carefully disengages each of the hooks 25 from the skin and suture material. This can be down by gently rotating each of the shafts 50a, 50b and then lifting the shafts 50a, 50b with attached locating members 20, 40 from the incisions.

12. The surgeon then closes the incision by tensioning and tying off the suture.

[0076] It is important to appreciate that the peg 80 associated with each of the first and second locating members 20, 40 presses downwardly on the skin when in the locked position helping to hold the tissue from above and prevent the skin from being inadvertently released from the associated hook 25.

[0077] It is also important to appreciate that because the first and second locating members 20, 40 are mirror image of one another, when they are located on the shafts 50a, 50b and the inner and outer end units 60, 70 connected thereto, the rows of first and second locating members 20, 40 are positioned so that a leg 24" of a second locating member 40 is located between two legs 24' of two first locating members 20. This positioning is most clearly seen in Figures 3 and 14.

[0078] Further, when the inner and outer end units 60, 70 are applied to the inner and outer most first and second locating members 20, 40 on each of the shafts 50a, 50b, the hooks 25 of the first and second locating members 20, 40 are moved to an operative suturing position. In the operative suturing position, the hooks 25' extending from the first locating members 20 are interlaced between the hooks 25" extending from the second locating members 40 (Figure 14). The distance the hooks 25 are interlaced in a direction perpendicular to the length of the shafts 50a, 50b is a distance sufficient to ensure that the parts of the tissue held by the interlaced hooks 25 are also similarly interlaced and so that those parts cross over different sides of the imaginary closure line CL. This effectively results in the tissue being interlaced in a zigzag fashion in the same manner required for conventional subcuticular suturing.

[0079] The needle receiving aperture 25a of each of the hooks 25 is located so that a needle 150 passed through the needle receiving aperture 62 of the inner end unit 60 will then pass through the needle receiving apertures 25a of the hooks 25 and then through the needle receiving aperture 72 of the outer end unit 70. All of these apertures 62, 25a, 72 are preferably located so that their longitudinal central axis is coincident with the imaginary closure line CL. In this way the needle 150 will pass along the imaginary closure line CL and thus through the interlaced subcutaneous tissue. Figure 14 clearly depicts the shank of the needle 125 located in the needle receiving apertures 25a of the hooks 25.

[0080] From the above description it will be apparent that once the surgeon has properly affixed the apparatus 10 to the sides of the incision to be closed, suturing of the incision is achieved by simply driving the needle 150 using the launcher 120 through the interlaced skin and subcutaneous tissue in one single action. Once the needle 150 is pulled all the way through the apparatus 10 and out of the patient so that the suture can be grasped by the surgeon, the apparatus 10 is removed from the incision. The suture can then be tensioned to bring the opposed sides of the incision together, with the required tension, and then tied off to secure the incision closed.

[0081] Embodiments of the invention are advantageous because large incision sizes can be quickly closed with a subcutaneous suture. This has the advantage of minimising surgical time, whilst still providing a subcuticular suture which typically results in a more cosmetically appealing scar, with fewer complications.

[0082] It is envisaged that it may be advantageous to be able to operate all of the pegs associated with the first locating members in unison. It may also be

advantageous to be able to operate all of the pegs associated with the second locating members in unison. To this end, means for moving and locking the pegs of one row of the first locating members may be provided. Means for moving and locking the pegs of one row of second locating members may also be provided.

[0083] Similarly, means for unlocking all of the pegs on each row of the locating members may be provided. A means for allowing all the pegs to release the skin (such as a spring mechanism, which, when activated, allowed all the pegs to spring away from the skin) may also be provided.

[0084] In another embodiment of the invention, the "C" or "U" shape of the hooks 25' and 25" may be composed of two or more parts. In this way, during step 1 1 recited above, in which the hooks 25 are disengaged from the skin, the two parts may be separated to allow a larger space for separating the hooks 25 from the suture material.

[0085] In yet another embodiment of the invention, a means to propel the needle more easily is envisaged. Such means may include a hand-operated ratchet mechanism, a shuttle, and/or some additional method of providing force to propel the needle (e.g. a spring).

[0086] The embodiments have been described by way of example only and modifications within the spirit and scope of the invention are envisaged.

Claims

1 . A skin suturing apparatus for suturing together first and second longitudinal sides of an incision, said apparatus including a first locating member for locating a part of a first side of the incision, a second locating member for locating a part of a second side of the incision, wherein the first and second locating members are configured to locate the parts of the first and second sides of the incision so that an imaginary closure line extends through said located parts.

2. A skin suturing apparatus according to claim 1 further including a needle receiving aperture with a longitudinal axis generally coincident with the imaginary closure line through which a needle may be passed.

3. A skin suturing apparatus according to claim 1 or claim 2 including a plurality of first locating members and a plurality of second locating members.

4. A skin suturing apparatus according to claim 3 wherein the plurality of first locating members are connected together to form a row of first locating members and the plurality of second locating members are connected together to form a row of second locating members.

5. A skin suturing apparatus according to claim 4 wherein the plurality of first locating members are arranged to be connected together by mounting on a first shaft and the plurality of second locating members are arranged to be connected together by mounting on a second shaft.

6. A skin suturing apparatus according to claim 5 wherein in use of the apparatus, the first and second shafts extend generally parallel to one another and generally parallel to the first and second longitudinal sides of the incision.

7. A skin suturing apparatus according to claim 5 or claim 6 wherein the number of first and second locating members mounted on each shaft is variable.

8. A skin suturing apparatus according to any one of claims 5 to 7 wherein adjacent first locating members on the first shaft are connected together to prevent relative movement there between and .adjacent second locating members on the second shaft are connected together to prevent relative movement there between.

9. A skin suturing apparatus according to claim 8 wherein a male/female detent type connection is provided to connect adjacent locating members on the respective first and second shafts.

10. A skin suturing apparatus according to any one of the preceding claims wherein each of the first and second locating members includes a body and means for engaging with skin so that the engaged skin can thereafter be located so that the imaginary closure line extends through the located skin.

1 1 . A skin suturing apparatus according to claim 10 wherein the engaging means includes a hook.

12. A skin suturing apparatus according to claim 1 1 wherein the hook has a generally "C" or "U" shape.

13. A skin suturing apparatus according to any one of the preceding claims further including a peg associated with each of the first and second locating members, each said peg arranged to facilitate holding of tissue in a required position.

14. A skin suturing apparatus according to claim 13 wherein each peg is arranged for sliding engagement relative to the associated locating member.

15. A skin suturing apparatus according to claim 14 wherein each locating member includes an elongate aperture through which the peg may be pushed.

16. A skin suturing apparatus according to claim 15 wherein the aperture in the locating member and the associated peg are configured so that the peg may be held in the required position against the tissue whilst suturing occurs.

17. A skin suturing apparatus according to any one of claims 3 to 16 further including first and second end units arranged to secure the row of first locating members and the row of second locating members together and in such a position that the parts of the first and second sides of the incision held by the first and second locating members are held so that the imaginary closure line extends through said located parts.

18. A skin suturing apparatus according to claim 17 wherein the inner end unit includes a needle receiving aperture.

19. A skin suturing apparatus according to any one of the preceding claims further including a needle cartridge.

20. A skin suturing apparatus according to claim 19 wherein the needle cartridge includes a needle case and a needle.

21 . A skin suturing apparatus according to claim 19 or claim 20 wherein the needle cartridge is arranged for connection to a needle receiving aperture.

22. A method of suturing a wound or an incision using a skin suturing apparatus, said method including the steps of: a) hooking tissue of a part of a first side of an incision with a first hook; b) hooking tissue of a part of a second side of an incision with a second hook; c) moving the first and the second hooks so that the parts of the first and

second sides of the incision are located so that an imaginary closure line extends through said located parts; and d) passing a needle generally coincident with the imaginary closure line and through the parts so that a suture secured to the needle can be pulled along the imaginary closure line and thereafter grasped by the surgeon.

23. A method of suturing a wound or an incision according to claim 22 wherein the first hook includes a plurality of first hooks and each of the first hooks are arranged to hook an associated part of the first side, and wherein the second hook includes a plurality of second hooks and each of the second hooks are arranged to hook an associated part of the second side.

24. A method of suturing a wound or an incision according to claim 22 or claim 23 further including the steps of: e) removing the hooks from the tissue; and f) tensioning the suture to close the incision.

25. A method according to claim 24 further including the step of removing the hooks from the suture material prior to tensioning the suture.

26. A method according to claim 24 or claim 25 including the steps of: g) securing the suture to close the wound or incision.