WO2004024006A1

WO2004024006A1 - Suture apparatus

Info

Publication number: WO2004024006A1
Application number: PCT/GB2003/003909
Authority: WO
Inventors: Josaphat Joseph Kabukoba
Original assignee: Surgi-Call Limited
Priority date: 2002-09-11
Filing date: 2003-09-10
Publication date: 2004-03-25
Also published as: AU2003264742A1; GB0221021D0

Abstract

The invention relates to suture apparatus and particularly but not exclusively to apparatus for securing a suture clip to suture material. The apparatus (10) comprises a body (12) comprising a handle assembly (20)coupled to a first end (15) of an elongate shank (16) defining a longitudinal axis AA and a closure assembly head (40) coupled to a second end of the elongate shank, opposite to the first end. The closure assembly head comprises a pair of members (42) at least one of which is moveable towards the other when securing a suture clip to suture material. The or each moveable member is configured to move in a direction substantially perpendicular to the longitudinal axis of the elongate shank.

Description

TITLE: SUTURE APPARATUS

DESCRIPTION

TECHNICAL FIELD The present invention relates to suture apparatus, particularly but not exclusively to an applicator for applying a suture clip to suture material, and also particularly but not exclusively to a suture clip for securing two sections of suture material together.

BACKGROUND ART

Laparoscopic (keyhole) surgical procedures involve by their very nature complex movements in confined spaces, and a variety of instruments have evolved to assist with such procedures, particularly suturing. For example, surgical crimping devices and methods of use are described in European patent applications published under EP 0 669 101A and EP 0 669 103A. As shown in Figure 1, an applicator (110) is provided which is able to deform and compress in si tu a securing member (120) around two lengths (130,140) of suture material (200) which are first pulled taut. The securing member (120) is able to maintain a prescribed amount of tension on the suture which extends through tissue (not shown) , even after the applicator (110) is removed.

More recently, the present applicant proposed in International application published under O00/61012 suture apparatus comprising a closed loop of suture material and a suture clip comprising: a body having a recess or opening for receiving and subsequently engaging two sections of the loop of suture material. The suture clip body further has an outer peripheral surface for engaging or abutting the trailing part of loop or surrounding tissue to lock the two sections of the loop of suture material relative to a trailing part after a suture has been formed. The peripheral surface has a profile for preventing the trailing part from riding over the suture clip once the suture has been formed.

There is now proposed an improved applicator for applying suture clips, and also an improved suture clip.

DISCLOSURE OF INVENTION In accordance with a first aspect of the present invention, there is provided apparatus for securing a suture clip to suture material, comprising: a body comprising a handle assembly coupled to a first end of an elongate shank defining a longitudinal axis; and a closure assembly head coupled to a second end of the elongate shank, opposite to the first end, the closure assembly head comprising a pair of members at least one of which is moveable towards the other when securing a suture clip to suture material, characterised in that the or each moveable member is configured to move in a direction substantially perpendicular to the longitudinal axis of the elongate shank. The pair of members in effect are opposed jaws or pincers with (at least initially) an opening therebetween for receiving the suture clip and suture material . By providing movement in a direction perpendicular to the longitudinal axis it becomes possible to position suture material between the opposed jaws simply by advancing the apparatus in a direction parallel to the longitudinal axis.

The apparatus may further comprise at least one linkage, the or each linkage extending between the handle assembly and one moveable member respectively, with movement of the or each linkage at the handle assembly controlling movement of its moveable member. The or each linkage (which may be rigid) allows movement of the or each moveable member to be controlled from a position spaced along the elongate shank from the closure assembly head. The handle assembly may comprise a first part moveable relative to a second part, with the first part being configured to displace the or each linkage when moved relative to the second part. The first part may be pivotally coupled to the second part which is rigidly coupled to the elongate shank. The handle assembly may be configured as a single-hand grip, with the first and second parts being moveable relative to each other when the handle assembly is squeezed in one hand.

The apparatus may further comprise a cutting assembly head coupled to the second end of the elongate shank, the cutting assembly head comprising a blade which is moveable relative tb an opposing component when cutting suture material trapped therebetween. The cutting assembly head may be mounted adjacent the closure assembly head and may be configured to cut surplus suture material extending proud of a suture clip being secured in place by the closure head assembly. In this way, the operations of securing the suture clip to suture material and cutting away surplus suture material may be performed by a single device without any need for repositioning between operations .

The opposing component may be an anvil, which in use is abutted by the blade when suture material is cut. Alternatively, the opposing component may be another blade, with the blades providing a scissor-action to cut suture material. Both blades may be moveable, each toward the other when cutting suture material. The apparatus may further comprise a coupling {e. g. rigid link or rod) between the blade and the handle assembly, with movement of the coupling at the handle assembly controlling movement of the blade. If the handle assembly comprises the aforementioned first and second parts, the first part may be configured to displace the coupling when moved relative to the second part. The first part may be configured to displace the or each linkage before it displaces the coupling. In this way, the operations of securing the suture clip to suture material and cutting away surplus suture material may be performed sequentially, rather than simultaneously.

The shank may be configured to store a plurality of suture clips, ready for use one after the other. The plurality of suture clips may be biased by a biasing device, e.g. a ramrod, towards the second end of the shank. The biasing device may be configured for direct manual operation, e.g. by a user pushing the ramrod to advance the stored suture clips after a suture clip has been secured to suture material . Alternatively or in addition and if the handle assembly comprises the aforementioned first and second parts, the biasing device may be configured for operation in dependence upon movement of the first and second parts relative to each other.

The apparatus may further comprise a needle holder assembly head coupled to the second end of the elongate shank, the needle holder assembly head including a holder member which is moveable relative to an opposing member between an open position for receiving a needle and a closed position in which the needle is gripped between the holder member and the opposing member. The holder member and opposing member are, in effect, opposing jaws which can be used to grip a suturing needle, which might, for example, have been pulled through tissue by a conventional needle holder. The apparatus can thus be used to hold the needle temporarily, e.g. while the conventional needle holder is detached from the needle and repositioned in readiness to perform a further step in a suturing procedure. In this way, it may not be necessary to use another instrument, such as forceps, to hold the suturing needle during re-positioning of the needle holder. The apparatus may further comprise a yoke extending between the needle holder assembly head and a user operable activating device located towards the first end of the elongate shank, with operation of the activating device controlling via the yoke movement of the holder member relative to the opposing member. The activating device may be located on the shank, perhaps near the handle assembly to permit operation of the activating device and gripping of the handle assembly with one hand.

The apparatus may further comprise a permanent bias urging the holder member towards the opposing member. For example, the holder member and opposing member may be spring biased to move to the closed position or the activating device may be sprung-loaded to achieve the same effect. This can simplify performance of the needle gripping and holding step by requiring user operation only during the initial needle gripping phase, thus, for example, freeing the user to direct his attention towards repositioning the conventional needle holder. The needle holder assembly head may be on a sleeve rotatable about the longitudinal axis of the shank. The sleeve may extend towards the handle assembly and terminate, perhaps at the handle assembly, in a rotation joint configured for rotation of the sleeve in relation to the handle. Thus, a user may rotate the sleeve to bring the needle holder assembly head into an appropriate operative position.

If the apparatus comprises a cutting assembly head, the needle holder assembly head and the cutting assembly head may be located on opposite sides of the second end of the elongate shank. In addition, the needle holder assembly head and the cutting assembly head may be on a sleeve rotatable about the longitudinal axis of the shank. Thus, the sleeve may be rotated to bring one or other of the needle holder assembly head and the cutting assembly head into an operative position.

According to another aspect of the present invention, there is provided apparatus for securing a suture clip to suture material, comprising: a body comprising a handle assembly coupled to a first end of an elongate shank defining a longitudinal axis; a closure assembly head coupled to a second end of the elongate shank, opposite the first end, the closure assembly head comprising a pair of members at least one of which is moveable towards the other when securing a suture clip to suture material; and a cutting assembly head coupled to the second end of the elongate shank, the cutting assembly head including a blade which is moveable relative to an opposing component when cutting suture material therebetween. The cutting head assembly may be registered with and adjacent to the closure assembly head to cut surplus suture material extending proud of a suture clip being secured in place by the closure head assembly. Other features of the cutting head assembly and the closure assembly head have been defined with reference to the first aspect of the present invention. According to another aspect of the present invention, there is provided apparatus for securing a suture clip to suture material, comprising: a body comprising a handle assembly coupled to a first end of an elongate shank defining a longitudinal axis; a closure assembly head coupled to a second end of the elongate shank opposite the first end, the closure assembly head comprising a pair of members at least one of which is moveable towards the other when securing a suture clip to suture material; and a needle holder assembly head coupled to the second end of the elongate shank, the needle holder assembly head including a holder member which is moveable relative to an opposing member between an open position for receiving a needle and a closed position in which the needle is gripped between the holder member and the opposing member. Features of the needle holder assembly head may be the same as those defined with reference to the first aspect of the present invention.

The apparatus may comprise a cutting assembly head. Features of the cutting assembly head and the closure assembly head may be the same as those defined with reference to the first and second aspects of the present invention. In accordance with yet another aspect of the present invention, there is provided a suture clip comprising first and second parts hinged together and moveable between a first position defining an opening for lateral insertion of suture material into a central passageway between the parts, and a second position where the opening is closed by the parts, characterised in that the first and second parts have edge profiles which interlock to secure the parts in the second position.

The passageway may be configured to grip suture material therein when the first and second parts are in the second position. In this way, there is no need to crimp

(i.e. physically deform) the suture clip around suture material when securing thereto. The passageway may include ridges on each part, to trap suture material therebetween. The ridges on opposite parts may be offset and may be configured to introduce a kink in suture material trapped between adj acent ridges .

BRIEF DESCRIPTION OF DRAWINGS Embodiments of the present invention will now be described by way of example, with reference to the accompanying figures, in which:

Figure 1 is a perspective view of a prior art suture clip applicator;

Figure 2 is a perspective view of a suture clip applicator embodying the present invention;

Figure 3 is a perspective view showing head details of the suture clip applicator of Figure 2;

Figure 4 is an exploded perspective view showing head and shank details of the applicator of Figure 2;

Figure 5 is a perspective view showing handle details of the suture clip applicator of Figure 2 ; Figure 6A and 6B are representations of an alternative embodiment of the present invention, respectively in closed and open configurations;

Figures 7A and 7B show perspective views of a suture clip embodying the present invention, respectively in closed and open configurations; and

Figures 8A and 8B show perspective and cut-away views respectively of another suture clip embodying the invention, in use.

BEST MODE FOR CARRYING OUT THE INVENTION

Figure 2 shows an applicator (10) embodying one aspect of the present invention, and comprising a body (12) comprising a handle assembly (20) mounted on a first or proximal end (15) of a shank (16) . The shank (16) defines the longitudinal axis AA of the applicator (10) . A closure assembly head (40) is mounted on a second or distal end (17) of shank (16) . As shown in Figure 3, the closure assembly head (40) comprises a pair of opposed members (42) which are configured to hold a suture clip (18) when the suture clip is in an open configuration. The pair of opposed members (42) are moveable towards each other, with a substantial component of movement towards each other being in a direction substantially perpendicular to the longitudinal axis AA, to secure the clip (18) into a closed configuration. A cutting assembly head (70) is also mounted on the second end (17) of shank (16) , adjacent and in registration with closure assembly head (40) . The cutting assembly head (70) comprises a pair of opposed blades (72) which are configured to cut suture material (not shown) once the suture clip (18) has been secured in place.

The closure head assembly (40) and the cutting head assembly (70) will each be described in more detail with reference to Figures 3 and 4, as follows. It should be noted that the cutting assembly of Figure 4 has a slightly different structure from the cutting head assembly of Figure 3. However, the different structures of the cutting head assemblies of Figures 3 and 4 have no material effect. The second end (17) of shank (16) is substantially "Y" -shaped to define a pair of guides (44) for guiding movement of each member (42) . Each member is coupled to a rigid linkage (46) which extends through an aperture (48) in its respective guide (44) . Opposing surfaces (47) and (49) of the linkage (46) and aperture (48) respectively abut each other and are both inclined relative to the longitudinal axis AA of the applicator (10) . When the linkages (46) are advanced relative to shank (16) towards second end (17), the opposing surfaces (47,49) slide over each other, directing the members (42) towards each other.

The blades (72) are both pivotally mounted via pivot (74) to the second end (17) of shank (16) . Pivotal movement of the blades (72) around the pivot (74) produces a scissor action to cut suture material. Pivotal movement of the blades (72) is controlled by sliding movement of the housing (76) along the longitudinal axis 7AA of the applicator (10) . The housing (76) is attached to a rigid coupling rod (78) , and includes two pairs of upper and lower limbs (80,82), disposed respectively above and below the blades (72) , one on either side of pivot (74) . Each pair of upper and power limbs (80,82) are joined together by a pin (84) which passes through an elongate aperture

(86) in its respective blade (72) . The apertures (86) are each inclined relative to the longitudinal axis AA when the blades (72) are open to receive suture material, and the pins (84) are a sliding fit in their respective apertures (86) . When the housing is advanced relative to the shank

(16) , the pins (84) slide along the apertures (86) drawing the blades (72) together with a scissor action.

Figure 5 shows the handle assembly (20) in more detail. The handle assembly comprises a first part (22) which is pivotally coupled via pivot (24) to a second part

(26) which is rigidly coupled to shank (16) . Movement of the first part (22) towards the second part (26) in the direction of arrow S pivots the lever actuator (28) towards the first end (15) of the shank (16) . Pivotal movement of the lever actuator (28) compresses spring (30) , urging block (32) forwards towards stop (34) . The block (32) is coupled to linkages (46) , and thus movement of the former pushes the latter towards the second end (17) of the shank (16) , thereby actuating the closure head assembly (40) . Once the block (32) reaches the stop (34) further movement of lever actuator (28) is accommodated by additional compression of the spring (30) , with internal spring guide (36) sliding within the block (32) . At some point after the block (32) has reached the stop (34) , the lever actuator (28) abuts the coupling rod (78) . Once in contact with the coupling rod (78) , further movement of the lever actuator (28) towards the first end (15) of the shank (16) will push the coupling rod (78) forwards towards the second end (17) , thereby actuating the cutting head assembly (70) .

The handle assembly (20) provides a two-stage mechanism for firstly operating the closure head assembly

(40) and thereafter operating the cutting head assembly (70) , all within one continuous squeeze of handle parts (22,26) together. The two-stage mechanism allows a user if he so wishes to pause between operating the closure head assembly and operating the cutting head assembly. For example, the user might pause to check the integrity of a suture clip that has just been applied with the closure head assembly. If the suture clip has been applied properly, the user may then squeeze the handle parts further to cut surplus suture material extending proud of the suture clip. If, on the other hand, the suture clip has not been applied properly, the user may then remove the suture clip and use the closure head assembly to apply a fresh suture clip. The shank (16) is hollow and configured to store a plurality of suture clips (18) , ready for use one after the other. The suture clips (18) are biased towards the second end (17) of the shank (16) by ramrod (90) (which constitutes a biasing device) which is held in place by resilient flaps (92) . The ramrod (90) may be advanced manually each time a suture clip (18) is used. Alternatively, the ramrod (90) may be advanced automatically by pawl (94) pivotally coupled via pivot (96) to lever actuator (28) as the closure head assembly (40) and cutting head assembly (70) are operated sequentially by squeezing handle parts (22,26) together.

Figures 6A and 6B show an alternative embodiment of an applicator (10) embodying an aspect of the present invention, and comprising a body (12) having a handle assembly (20) mounted on a first end (15) of a shank (16) . The shank (16) defines the longitudinal axis AA of the applicator (10) . A closure assembly head (40) is mounted on a second end (17) of the shank (16) ; the closure assembly head is represented in Figures 6A and 6B by a dashed line. The closure assembly head (40) is described above in detail with reference to Figures 2 and 3. A cutting assembly head (70) is mounted on the second end (17) of the shank (16) , adjacent to closure assembly head (40) . The cutting assembly head (70) is described above in detail with reference to Figures 2 and 3. A needle holder assembly head (100) is also mounted on the second end (17) of the shank (16) , adjacent closure assembly head (40) and on an opposite side of the shank to the cutting assembly head (70) . The needle assembly head (100) comprises a holder member (102) which is moveable in relation to an opposing member (104) . A yoke (106) extends between the needle holder assembly head (100) and a user operable activating device (108) .

The holder member (102) is biased, e.g. by means of a spring, so that the needle holder assembly head (100) tends towards the closed position shown in Figure 6A in the absence of user operation of the activating device (108) . When a user wishes to hold a needle temporarily he or she operates the activating device (108), e.g. by pulling back on the activating device towards the handle assembly, to move the holder member (102) via the yoke (106) towards the open position shown in Figure 6B. The applicator (10) can then be manoeuvred so that the needle is received between the holder member (102) and the opposing member (104) and the activating device (108) released so that the bias returns the needle holder assembly head to the closed position of Figure 6A, thereby holding the needle. When the user wishes to release the held needle, he operates the activating device as described above to return the needle holding assembly to the open configuration of Figure 6A.

As shown in Figures 6A and 6B, the closure assembly head (40) , the cutting assembly head (70) and the needle holding assembly head are mounted on a sleeve (112) which extends around the shank (16) and terminates in a rotation joint (114) near to the handle assembly (20) . Although Figures 6A and 6B show the needle holding assembly head (100) and the cutting assembly head (70) located on opposite sides of the sleeve (112) , the needle holding assembly head and cutting assembly head may have any other location in relation to each other. For example, the cutting assembly head (70) may be located at the top of the shank (as shown in Figures 6A and 6B) and the needle holding assembly head (100) may be located on one side of the sleeve. The rotation joint (114) allows a user to rotate the sleeve (112) about the longitudinal axis of the shank (AA) in relation to the handle assembly (20) and thereby position the closure assembly head (40) , the cutting assembly head (70) and the needle holding assembly head (100) in an appropriate operative position.

Figures 7A and 7B and Figures 8A and 8B show frustoconical and cylindrical suture clips (180) , either of which may be used with applicator (10) . Each suture clip

(180) comprises two parts (182,184) which are hinged together along hinge axis HH. As a result, the two parts

(182,184) are moveable relative to each other from a first position { e . g. Figure 7B) to a second position { e . g. Figure 7A) . In the first position, the opposing sides (186,188) of the parts (182,184) are spaced apart defining an opening (190) to a central passageway (192) for receiving suture material. In the second position, the opposing sides

(186,188) of the parts (182,184) abut each other to close the opening (190). The parts (182,184) include end profiles

(194,196) which interlock when in the second position, preventing the suture clip (180) from springing open when in the second position with suture material (198) trapped inside. The central passageway (192) of the suture clip

(180) includes ridges (201) on the radially inner periphery of each part (182,184). The ridges (201) are offset in an axial direction, so one ridge on one part (182) registers with the trough (202) between two ridges on the other part

(184) . In this way, the ridges (201) force the suture material to kink when trapped in the suture clip (180) , as shown schematically in Figure 8B.

Claims

CLAIMS :

1. Apparatus (10) for securing a suture clip (18) to suture material, comprising: ' a body (12) comprising a handle assembly (20) coupled to a first end (15) of an elongate shank (16) defining a longitudinal axis (AA) ; and a closure assembly head (40) coupled to a second end (17) of the elongate shank, opposite to the first end, the closure assembly head comprising a pair of members (42) at least one of which is moveable towards the other when securing a suture clip to suture material, characterised in that the or each moveable member is configured to move in a direction substantially perpendicular to the longitudinal axis of the elongate shank.

2. Apparatus according to claim 1 further comprising at least one linkage, the or each linkage extending between the handle assembly and one moveable member respectively, with movement of the or each linkage at the handle assembly controlling movement of its moveable member.

3. Apparatus according to claim 2 , in which the handle assembly comprises a first part moveable relative to a second part, with the first part being configured to displace the or each linkage when moved relative to the second part .

4. Apparatus according to claim 3 , in which the first part is pivotally coupled to the second part which is rigidly coupled to the elongate shank.

5. Apparatus according to claim 3 or 4 , in which the handle assembly is configured as a single-hand grip, with the first and second parts being moveable relative to each other when the handle assembly is squeezed in one hand.

6. Apparatus according to any preceding claim further comprising a cutting assembly head coupled to the second end of the elongate shank, the cutting assembly head comprising a blade which is moveable relative to an opposing component when cutting suture material trapped therebetween.

7. Apparatus according to claim 6, in which the cutting assembly head is mounted adjacent the closure assembly head and is configured to cut surplus suture material extending proud of a suture clip being secured in place by the closure head assembly.

8. Apparatus according to claim 6 or 7, in which the opposing component is an anvil, which in use is abutted by the blade when suture material is cut .

9. Apparatus according to claim 6 or 7, in which the opposing component is another blade, with the blades providing a scissor-action to cut suture material .

5 10. Apparatus according to claim 9, in which both blades are moveable, each toward the other when cutting suture material .

11. Apparatus according to any one of claims 6 to 10, in 10 which the apparatus further comprises a coupling between the blade and the handle assembly, with movement of the coupling at the handle assembly controlling movement of the blade .

15 12. Apparatus according to claim 11 when dependent on claim 3 , in which the first part is configured to displace the coupling when moved relative to the second part.

13. Apparatus according to claim 12 , in which the first 20 part is configured to displace the or each linkage before it displaces the coupling.

14. Apparatus according to any preceding claim, in which the shank is configured to store a plurality of suture

25 clips, ready for use one after the other.

15. Apparatus according to claim 14, in which the plurality of suture clips are biased by a biasing device towards the second end of the shank.

16. Apparatus according to claim 15, in which the biasing device is configured for direct manual operation.

17. Apparatus according to claim 15 or 16 when depending from claim 3, in which the biasing device is configured for operation in dependence upon movement of the first and second parts of the handle assembly relative to each other.

18. Apparatus according to any preceding claim further comprising a needle holder assembly head coupled to the second end of the elongate shank, the needle holder assembly head including a holder member which is moveable relative to an opposing member between an open position for receiving a needle and a closed position in which the needle is gripped between the holder member and the opposing member.

19. Apparatus according to claim 18 further comprising a yoke extending between the needle holder assembly head and a user operable activating device located towards the first end of the elongate shank, with operation of the activating device controlling via the yoke movement of the holder member relative to the opposing member.

20. Apparatus according to claim 19, in which the activating device is located on the shank near the handle assembly whereby the activating device may be operated and the handle assembly gripped with one hand.

21. Apparatus according to any one of claims 18 to 20, further comprising a permanent bias urging the holder member towards the opposing member.

22. Apparatus according to any of claims 18 to 21, in which the needle holder assembly head is on a sleeve rotatable about the longitudinal axis of the shank.

23. Apparatus according to claim 22, in which the sleeve extends towards the handle assembly and terminates in a rotation joint configured for rotation of the sleeve in relation to the handle.

24. Apparatus according to any of claims 18 to 23 when dependent on claim 6, in which the needle holder assembly head and the cutting assembly head are located on opposite sides of the elongate shank.

25. Apparatus according to claim 24, in which the needle holder assembly head and the cutting assembly head are on a sleeve rotatable about the longitudinal axis of the shank.

26. A suture clip (180) comprising first and second parts (182, 184) hinged together and moveable between a first position defining an opening (190) for lateral insertion of suture material into a central passageway (192) between the parts, and a second position where the opening is closed by the parts, characterised in that the first and second parts have edge profiles (194, 196) which interlock to secure the parts in the second position.

27. A suture clip according to claim 26, in which the passageway is configured to grip suture material therein when the first and second parts are in the second position.

28. A suture clip according to claim 26 or 27, in which the passageway includes ridges on each part, to trap suture material therebetween.

29. A suture clip according to claim 28, in which the ridges on opposite parts are offset and are configured to introduce a kink in suture material trapped between adjacent ridges.