WO2004049898A2

WO2004049898A2 - Suturing method

Info

Publication number: WO2004049898A2
Application number: PCT/GB2003/005252
Authority: WO
Inventors: John Dalton Griffith
Original assignee: Griffith Textile Machines Limited
Priority date: 2002-12-03
Filing date: 2003-12-03
Publication date: 2004-06-17
Also published as: WO2004049898A3; AU2003294117A1; GB0228134D0; AU2003294117A8

Abstract

A method of suturing using a suturing implement and thread clamp combination. The method includes mounting the clamp (3) on the suturing implement, inserting the implement to grip tissue to be sutured in between said jaws and passing a suturing needle, manipulated by a holder separate to the implement, through the gripped tissue and said thread clamp.

Description

SUTURING METHOD

The present invention relates to a suturing method and a suturing implement and suture thread clamp for use in the method.

In certain types of surgical procedure, such as laparoscopic procedures, it is necessary for a surgeon to manually produce sutures internally of a patient's body using a needle holder to guide a threaded needle. The needle holder is manipulated through a cannula in the patient's body to guide the needle and subsequently the surgeon needs to complete the suture by tying each of the suture thread ends together. This is usually a difficult and time consuming process.

The general aim of the present invention is to provide a suturing method, and a suture assembly and applicator, which facilitates the suturing process in laparoscopic type procedures.

According to one aspect of the present invention there is provided a suturing implement adapted to be capable of inserting a suture thread clamp through a cannula and to hold the thread clamp for performing a suturing operation, the suture thread clamp including a passageway through which a length of thread may be threaded in one direction, thread gripping means associated with the passageway which acts to permit passage of thread in one direction along the passageway but which acts to prevent passage of thread along the passageway in the opposite direction, the suturing implement including an elongate support body having at one end a seat for detachably securing the thread clamp to the support body, the elongate body being in the form of a pair of clamp jaws movable between a jaws closed position whereat the jaws are closely spaced to be able to grip tissue to be sutured therebetween and a jaw open position whereat the jaws are widely spaced to release tissue which may be gripped between the jaws when at the said closed position, said seat being formed on one of said jaws at a location which enables a suture needle, manipulated by a holder separate to the suturing implement, to be inserted through said passageway of the suture thread clamp when the jaws are in said closed position.

According to another aspect of the present invention there is provided, in combination, a suturing implement as defined above and a said thread clamp.

According to another aspect of the present invention there is provided a method of suturing using the combination defined above, the method including mounting the clamp on the suturing implement, inserting the implement through a cannula in the patient, operating the implement to grip tissue to be sutured in between said jaws and passing a suturing needle, manipulated by a holder separate to the implement, through the gripped tissue and said thread clamp.

According to another aspect of the present invention there is provided a suture thread clamp including a clamp body having a passageway through which a length of thread may be threaded and a thread gripping means associated with the passageway which acts to permit passage of tliread in one direction along the passageway but which acts to prevent passage of thread along the passageway in the opposite direction, the thread gripping means including a resiliently deflectable barb which extends across the passageway from one side wall to an opposed side wall of the passageway, the terminal end of the barb being biased into abutment with a clamp face.

Various aspects of the present invention are hereinafter described with reference to the accompanying drawings, in which:-

Figure 1 is a schematic illustration of a suture assembly according to an embodiment of the present invention;

Figure 2 is a schematic illustration showing the suture assembly of Figure 1 forming a suture;

Figure 3 is a plan view of a suture thread clamp according to a first embodiment of the present invention;

Figure 4 is a sectional view along line IN-IV of Figure 3; Figure 4a is an illustration of the clamp of Figure 4 shown without suture thread in the passageway;

Figure 5 is a sectional view similar to Figure 4 showing a thread clamp according to a second embodiment of the present invention;

Figure 6 is a side view of a thread clamp according to a third embodiment of the present invention;

Figure 7 is a plan view of the thread clamp shown in Figure 6;

Figure 8 is a part axial section along an applicator according to an embodiment of the invention;

Figure 9 is a section along line IX-IX in Figure 8; Figure 10 is an enlarged side view of the head of the applicator of

Figure 9, shown in its jaw closed condition;

Figure 11 is a view similar to Figure 10, in part section, showing the applicator in its jaw open condition;

Figure 12 is a section along XII-XII in Figure 8; Figure 13 is an end view of the head of the applicator shown in

Figure 8.

A suture assembly 20 is illustrated in Figure 1 and comprises a length of suture thread 2 which is attached at one end to a thread clamp 3 and is attached at its other end to a suture needle 1.

The principle of operation of the suture assembly 20 is illustrated in Figure 2. In this respect the needle 1 has been inserted through adjacent flaps of flesh 4 and then subsequently inserted through the thread clamp 3. The length of thread 2 thereby forms a suture loop 2 ^' passing through flaps of flesh 4 and is pulled to tighten the loop 2' and thereby hold the flaps of flesh 4 together in close proximity. The thread 2 after insertion by the needle 1 passes through thread clamp 3 and is held against withdrawal by the clamp 3 and so holds the loop 2 ' in a tight condition. The thread 2 may subsequently be severed at a location S beyond the clamp 3 in order to complete the suture and to detach the needle 1 and remaining thread 2.

In Figures 3 and 4 there is illustrated a first embodiment of a thread clamp 310 according to the present invention.

The thread clamp 310 includes a main body 10 having a slot 11 passing therethough. The slot 11 defines a passageway through which needle 1 may be passed in a direction shown by arrow A_N.

A thread gripping means 30 is operably located within the passageway for gripping thread 2 passing through the passageway and preventing its withdrawal in the direction shown by arrow A_P. The gripping means 30 is also operable to permit the needle 1 and thread 2 to be moved along the passageway in the direction of arrow A_N-

Preferably the gripping means 30 is in the form of a resiliently deflectable barb 13 having a base portion 14 which is mounted on the main body 10. The base portion 14 is preferably of channel form having a bottom portion 314, an inner leg 114 and an outer leg 214 on which is formed an inwardly directed projection 14' . The body 10 preferably includes a slot 25 formed in the lower edge of side wall 24 of the main body 10 and an outwardly directed projection 26.

The barb 13 is preferably formed form a length of resilient material such as a suitable plastics or spring steel.

Lateral displacement of the barb 13 relative to the slot 11 is prevented by opposed legs 114, 214 resiliently gripping side wall 24 and withdrawal of the barb 13 longitudinally of the slot 11 (i.e. in directions A_N, A_P) is prevented by co-operation of the overlapping projections 14^' , 26 and the bottom portion 314 with the bottom edge of the side wall 24 respectively.

As shown in Figure 4, the barb 13 is inclined downwardly relative to side wall 28 of main body 10 and has a head portion 29 which co-operates with the inner face 28a of wall 28 to trap thread 2 therebetween. As illustrated, barb 13 is resiliently biased upwardly such that head portion 29 is urged toward side wall 28 and into abutting engagement with the inner face 28a. Since the gripping means 30 is a separate component which is fixedly mounted on body 10, it is possible to ensure that the head portion 29 resiliently abuts face 28a under a predetermined pre-load force. This is particularly advantageous as it enables the clamp to positively grip suture threads having a small diameter, i.e. fine threads.

If the thread 2 is pulled in direction A_P the head 29 is urged by the thread 2 closer toward side wall 28 to increase its grip on the thread 2 and thereby prevent its movement. If the thread 2 is pulled in direction A_N, the thread 2 urges the head portion 29 further away from the side wall 28 and so permit its movement in direction A_N.

When needle 1 is initially inserted in direction AN through the passageway defined by slot 11, the barb 13 is deflected downwardly to the position shown at 13 ' in Figure 4. After the needle 1 has passed through the passageway the barb 13 returns to the position shown in solid lines to engage the thread 2.

In order to form a suture loop 2' which may be tightened by pulling the thread 2 in direction A_N, it is necessary for thread 2 to be anchored to the clamp 3 at its end 12 opposite to the end connected to the needle 1. As illustrated in the embodiments shown in Figures 4 to 7, this may be achieved in a variety of ways.

For example, in Figure 4 thread end 12 is moulded integrally with the main body 10 and exits the main body 10 in a direction which is lateral to the direction A_N.

In the embodiment of Figure 5, thread end 12 is also mounted integrally with the main body 10 but exits the main body 10 in a direction parallel to direction A_N.

With both embodiments shown in Figures 4 and 5 the suture assembly is manufactured and supplied for use in a pre-assembled condition.

The embodiment illustrated in Figure 5 may be modified by creating a plain bore 130 in the main body 10 during the moulding process. This enables thread 2 to be passed through the bore 130. Anchorage of the thread 2 to the body 10 may be achieved by forming a knot 131 in thread end 12 to thereby prevent thread 2 being pulled out of bore 30 in direction As-

In the embodiment shown in Figures 6 and 7, the main body 10 is provided with a pair of slots 11, 11 ' , each housing thread clamping means 30, 30' respectively. The clamping means 30 ' located in slot 11 ' acts to permit insertion and pulling of thread end 12 in direction Ai but prevent its movement in direction As-

A suturing operation using the suture assembly of the invention is preferably performed using a suturing implement or applicator 100 of the invention as exemplified in Figures 8 to 13. The applicator 100 shown in Figures 8 to 13 has a number of functions, such that a suture can be formed using only the applicator 100, a needle holder and scissors. Its first function is to hold the needle, suture thread and clamp 3 during insertion through the cannula; its second function is to hold the clamp 3 while the needle 1 is inserted into the tissue to be sutured using the separate needle holder (of conventional construction) and to also hold the clamp 3 so that the needle 1 can be easily threaded through the clamp 3; and its third function is to act as a tissue clamp which can be used to hold the tissue while suturing.

In Figures 8 to 13 the applicator 100 is illustrated holding a clamp 3 as shown in Figures 6 and 7.

The applicator 100 includes a main body in the form of a tube 58. Slidably connected to the tube 58 is a jaw assembly 150. The jaw assembly 150 includes a lower jaw 50 to which is pivotally attached an upper jaw 51 via a pivot 55. The jaws 50, 51 project axially beyond one end 58 ' of tube 58 and are preferably sized and shaped so as not to extend beyond the radial boundaries of tube 58 when the jaws 50, 51 are in their closed position as shown in Figure 8.

A resilient spring 56 is provided for biasing the upper and lower jaws apart to their jaw open position as shown in Figure 10.

The lower jaw 50 is fixedly mounted on a push rod 57 which extends longitudinally within the tube 58. A radially extending arm 60 is provided on the push-rod 57. The arm 60 passes through a longitudinally extending slot 62 formed in the tube 58 and is secured to a handle sleeve 61 which is axially slidably received on the tube 58. The axial end of the tube 58, remote from the end from which jaws 50, 51 project, is provided with a thumb holder 64 and the sleeve 61 is provided with a pair of finger holders 63. This enables a surgeon to hold the applicator 100 in one hand and to move the push-rod 57 axially along the tube 58 in either axial direction in a controlled manner.

The upper jaw 51 is provided with an inclined cam face 51 ^' which cooperates with an opposed cam face 59 ' formed in a tubular insert 59 located within the end 58 ' of tube 58.

The cam faces 51, 51 ' co-operate to control movement of jaw 51 about pivot 55 in response to axial movement of the push-rod 57 within tube 58.

Accordingly, the jaws 50, 51 may be moved to their jaw open position (Figure 10) by moving the push-rod 57 to extend jaws 50, 51 further beyond tube 58 and may be moved to their jaw closed position (Figure 8) by moving the push-rod 57 to retract the jaws 50, 51 into the tube 58.

The inner faces of the upper and lower jaws are preferably provided with serrations 170 which enable the jaws to more effectively grip tissue during the suturing process.

The jaws 50, 51 preferably are adapted to hold needle 1 during the initial insert of the applicator 100 into the cannula. In this respect, as illustrated in Figure 8, the upper jaw 51 is preferably provided with an axially extending groove 251 in which the body 10 of the needle 1 may be accommodated. The lower jaw 50 is preferably provided with a recess 250 in which the terminal end 1_E of the needle may be seated. Thus when the jaws 50, 51 are in their closed position, the needle is positively held within the jaw assembly 150.

The needle 1 may advantageously have a cylindrical portion 52 to which the suture thread 2 is fixed and a flat portion 53 which has some resilience. This means that in its natural state, it has a deep curvature for suturing (see Figure 10) but it can be stored in the applicator 100 pressed into a shallower curve (see Figure 8) to pass through the cannula. It is held in this position by being pressed between the lower jaw 50 and closed upper jaw 51.

The terminal end of lower jaw 51 is provided with a seat 210 in which a thread clamp 3 may be seated during the suturing process. Preferably the seat 210 is defined by a pair of opposed resilient tongues 49 which act to resiliently grip a clamp 3 therebetween.

The seat 210 is also preferably arranged such that the slots 11 extend in a direction perpendicular to the direction of closing of the jaws. This enables a needle to be easily threaded through the slots 11 when the jaws are in their closed position.

Preferably, to form a suture, a first cannula is needed for the applicator 100, a second cannula is needed for the needle holder and scissors and a third cannula is required for an endoscope.

The applicator 100 is initially inserted into the first cannula in the condition illustrated in Figures 8 to 11, i.e. holding the clamp 3, needle 1 and thread 2.

The thread 2 is arranged so that it forms a loop 71 which extends between the needle 1 and clamp 3. The loop 71 is located within the tube 58 in a gap between the push-rod 57 and internal wall of the tube 58. As shown in Figures 11 and 12, the loop 71 has a lower portion 70 and an upper portion 72. Thread portion 72 extends through the clamp 3 and emerges to define thread portion 74. Thread portion 74 extends longitudinally within the tube 58 to emerge through slot 62 and out of a slot 67 formed in sleeve 61. Arm 60 is preferably provided with a thread clamp in the form of a wedge shaped slot 175 to enable the thread portion 74 to be pulled taut and held under a slight tension. The thread passes through the clamp 3 such that pulling on thread portion 74 can cause the loop 71 to be shortened; however, the slight tension referred to above which is applied to the thread portion 74 is insufficient to draw the thread through clamp 3. The slight tension within the thread portion 74 is sufficient to ensure that the clamp 3 is retained within the seat 210.

With the applicator 100 inserted through the first cannula, the jaw 51 is opened and the needle grasped by the needle holder from the second cannula. The loop of thread 71 is pulled out from the tube 58 and suturing is commenced. During this procedure tissue can be held by jaws 50 and 51.

To close the suture loop the needle 1 is threaded through slot 11 in clamp 3.

The loop is then tightened by pulling whilst the thread 2 is located at position 75 shown in Figure 9. After this, the thread is released from the wedge slot 175 by moving it to position 75 ' (Figure 9) and the applicator

100 is partially withdrawn and this action allows it to release the clamp 3.

The suture thread ends are then cut by inserting scissors through the second cannula, and the needle withdrawn by holding the thread which is attached to it in the jaws.

Claims

1. A suture thread clamp including a clamp body having a passageway through which a length of thread may be threaded and a thread gripping means associated with the passageway which acts to permit passage of thread in one direction along the passageway but which acts to prevent passage of thread along the passageway in the opposite direction, the thread gripping means including a resiliently deflectable barb which extends across the passageway from one side wall to an opposed side wall of the passageway, the terminal end of the barb being biased into abutment with a clamp face.

2. A suture thread clamp according to Claim 1 wherein the resiliently deflectable barb is a separate component fixedly mounted on said body.

3. A suture thread clamp according to Claim 2 wherein the body is a plastics moulding.

4. A suture thread clamp according to Claim 1 or 2 wherein the barb is formed from a resilient material such as a suitable plastics or metal.

5. A suture thread clamp according to Claim 4 wherein the barb is formed on a mounting body which is fixedly attached to said clamp body such that the barb is biased into abutment with said clamp face under a predetermined pre-loaded force.

6. A suture thread clamp according to any of Claims 1 to 5 wherein said opposed clamp face is defined by said opposed side wall of the passageway.

7. A suturing implement adapted to be capable of inserting a suture thread clamp through a cannula and to hold the thread clamp for performing a suturing operation, the suture thread clamp including a passageway through which a length of thread may be threaded in one direction, thread gripping means associated with the passageway which acts to permit passage of tliread in one direction along the passageway but which acts to prevent passage of thread along the passageway in the opposite direction, the suturing implement including an elongate support body having at one end a seat for detachably securing the thread clamp to the support body, the elongate body being in the form of a pair of clamp jaws movable between a jaws closed position whereat the jaws are closely spaced to be able to grip tissue to be sutured therebetween and a jaw open position whereat the jaws are widely spaced to release tissue which may be gripped between the jaws when at the said closed position, said seat being formed on one of said jaws at a location which enables a suture needle, manipulated by a holder separate to the suturing implement, to be inserted through said passageway of the suture thread clamp when the jaws are in said closed position.

8. A suturing implement according to Claim 7 wherein the jaws when in said closed position are adapted to hold therebetween a suture needle oriented to extend longitudinally of said elongate body in order to enable said needle to be inserted through said cannula.

9. A suturing implement according to Claim 7 or 8 wherein the elongate body is slidably located in a sleeve and the jaws are biased to an open position, relative axial movement of the elongate body and sleeve controlling opening and closing of said jaws between said jaw open and closed positions.

10. A suturing implement according to any of Claims 7 to 9 wherein a length of suture thread is attached to one end of the thread clamp prior to mounting of the clamp in said seat, the elongate support body including a thread retention means at a location remote from said one end for releasably gripping the length of thread, the thread retention means permitting the thread between the thread clamp and retention means to be tensioned in order to assist retention of the thread clamp upon said seat.

11. In combination a suturing implement according to any of Claims 7 to 10 and a said thread clamp.

12. The combination according to Claim 11 wherein the thread clamp comprises a body through which the passageway extends, and the thread gripping means comprises one or more barb elements projecting into the passageway.

13. The combination according to Claim 12 wherein the body is a plastics moulding.

14. A method of suturing using the suturing implement and thread clamp combination according to any of Claims 11 to 13, the method including mounting the clamp on the suturing implement, inserting the implement through a cannula in the patient, operating the implement to grip tissue to be sutured in between said jaws and passing a suturing needle, manipulated by a holder separate to the implement, through the gripped tissue and said thread clamp.