AU672439B2 - Suture securing apparatus - Google Patents

Description

AUSTRALIA

Patent Act CO0M PL E TE SP E CI F IC A TIO0N

(ORIGINAL)

Class Int. Class Application Number: Lodged: Complete Specification Lodged: Accepted: Published: Pri ori ty: Related Art: Names(s) of Applicant(s): AMEflICAP CYAN".?AM1B COMPAlNY- Actual Inventor(s): Christopher Martin o Our Address for Service is: Patent anid Trade tMark-Attrneys 'c gSoc) 367 Cullin Street Melbournc, Australia, 3900 Complete Specification for the invention entitled:- SUTURE SECURING APPARATUS The following statement is a full description of this invention, including the best method of performing it known to applicant(s): I 2 SUTURE SECURING APPARATUS The present invention relates generally to surgical instruments, more particularly it relates to a suture securing .9vice, an apparatus for delivery of such a device and a method for tying sutures. It will be convenient to hereinafter refer to the suture securing apparatus in relation to endoscopic surgery however it should be noted that the invention has a wider application.

The basic principles of surgery are incision, dissection, traction, counter-traction, ligation and suturing. These principles are well established and mastered in conventional "open" invasive surgical procedures where access to the surgical site is gained by incision through the patient's skin and body wall to expose the site. In recent times attention has been o• directed towards least invasive surgical procedures or non-invasive procedures such as endoscopy, which encompasses arthroscopy, laparoscopy, duodenoscopy, gastroscopy and the like, where access to the surgical site is gained by introducing surgical instruments down one or more portals and/or gastrointestinal tract from the mouth or anus and/or urinary tract via the urethra. Least invasive surgery, where possible, has many benefits over conventional invasive procedures such as reduced surgical trauma, lessened anaesthesia and shortened recovery times, leading to reduced hospital costs, greater patient comfort and earlier return to work.

Although some of the technology for laparoscopic surgery has been available for many years, the first laparoscopic cholecystectomy performed in 1987 has 9707i 3

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stimulated the interest of general surgeons in laparoscopic surgery. Many general surgeons have transferred the basic principles of surgery to laparoscopic and endoscopic surgery and have mastered with reasonable ease these principles with the exception of suturing. In endoscopic procedures difficulty arises in tying of a suture as the surgeon can only use instruments to manipulate the required knots. Manipulation of the suture is hindered as usually the surgeon has only a two dimensional viewing field the suture site being visible by use of a camera and television screen or specialized scope. The problem of suturing and especially tying knots during laparoscopic surgery has become more apparent as surgeons have moved from resectional surgery i.e. where 15 part of an organ or tissue is completely or partially removed such as cholecystectomy or appendectomy, to surgery which requires suture placement such as procedures of fundoplication, bowel resection etc. Resectional procedures such as cholecystectomy and appendectomy generally only require ligature or clip application to tie off the removed organ or blood vessel. Devices have been developed to facilitate intracorporeal placement of such clips or ligatures and the application of such ligatures or clips is relatively simple when compared to tying of 25 intracorporeal knots in sutures. At the present time the average surgeon is not confronted with the need for intracorporeal knot tying frequently enough to become adept at this skill and this may contribute to longer operating times. Considerable time and practice may be required before a surgeon becomes skilled at tying of a e r 9707i 4

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e sc o rr a knots during endoscopic surgery.

A method for tying knots extracorporeally has been developed where the slip knot is tied in the suture outside the body of the patient and then positioned at the desired site by means of a push-rod into the body. While this method is successful to some extent it suffers from a number of disadvantages. Many endoscopic procedures involve the inflation of a body cavity with a pressurized gas such as carbon dioxide so that a space is created in the body to make the surgical site visible. The gas pressure is kept constant to maintain the visual field and if the pressure is reduced by the escape of gas the visual field is lost or impaired as the body tissues resume their usual positions. In tying a knot in a suture outside the 15 body it is necessary to pass the knot beyond a seal established to create the internal gas space. This involves breaking of the gas seal and the temporary loss of the gas space and hence the visual field as gas escapes when the suture is being passed into the body.

Secondly, the extracorporeally tied knots are not always as secure as would be desirable and thus present the risk of failure.

Thirdly, extracorporeally tied knots are not always satisfactory for securing opposite ends of a suture 25 which closes an elongate wound.

The applicant has described a novel device for securing a suture in co-pending Australian Application No. the entire contents of which are herein incorporated by reference. The novel suture securing device comprises:bS 9707i I':\OI'ER\SEWW 732-93.227 14/8/96 a surgically implantable body having a tissue abutting side and a suture loop side; and passage through said body, the passage having an opening adjacent the tissue abutting side and another opening adjacent the suture loop side.

In order to facilitate positioning of such a suture securing device it is desirable to provide apparatus which can engage such device and assist in tying a suture about the device, and then assist in moving the device along the suture to the desired position.

Accordingly it is an object of preferred embodiments of the present invention to provide a suture securing apparatus suitable for holding a suture securing device, assisting in tying a suture about said device and positioning said device.

It is another object of preferred embodiments of the invention to provide an apparatus which can be utilized in endoscopic surgery to perform the functions of holding, tying and positioning a suture securing device.

It is yet another object of preferred embodiments of the invention to provide apparatus which can be used in endoscopic surgery to perform the abovementioned functions without the need for removal of the apparatus from the operating site.

It is still another object of preferred embodiments of the invention to provide an ii: attachment to a suture securing apparatus which has a suture securing device pre-loaded thereon to allow rapid tying of a suture.

i It is another object of preferred embodiments of the invention to provide a method for adjustment of a suture securing device using a suture securing apparatus.

6beme apparent from the following de cription. AcL<rcA'4o o. FYtn af sp. 'k Vrcse 2-ov n a further aspect of the invention there is provided an apparatus for delivering a suture securing device as described above to a desired surgical site, including an elongate hollow body adapted at one end to releasably engage said suture securing device; a suture recovery means within said elongate hollow body adapted to draw a loop of suture through ofirst suture passage of the suture securing device; and a suture clamping means within said elongate hollow body; suture clamping means. adapted to securely engage the free end of suture which has been passed through the loop in said suture securing device.

So It will be understood that the delivery apparatus according to the present invention may be capable of releasably engaging a suture securing device, drawing a loop of suture through the passage in the securing device and clamping a suture.

The elongate hollow body of the delivery apparatus may include a projecting member at one end adapted to releasably engage with corresponding locating means on the suture securing device.

Preferably the projecting member includes a pair of arms adapted to engage corresponding locating recesses in the suture securing device. More preferably the arms include tines resiliently biased towards engagement with the suture securing device.

The elongate hollow body may include a handle or 7 the like at its other end. Preferably the suture recovery means and/or said suture clamping means are actuated in the region of said handle. More preferably the suture recovery means and/or suture clamping means are retractable along the length of the elongate body.

Accordingly the delivery apparatus may further include means for releasing said tines. In one embodiment the releasing means may include a ram, which acts upon cams located on the tines. When the ram contacts the cams, the tines are forced apart to release the device held thereby. Preferably the ram is actuated by a plunger, or other suitable means at the handle end of the delivery apparatus.

In this embodiment the apparatus may be provided 15 in combination with integral suture recovery means and/or suture clamping means, or without said suture recovery means and/or suture clamping means.

.000 The suture clamping means may include two *000 0. cooperating members. The suture clamping means may include a delivery suture securing apparatus wherein said S suture clamping means includes an abutment portion and a 00.0 *ee*0 tongue member adapted to bear upon the abutment portion such that when a suture is passed through the loop, the 0 tongue is pressed against the suture to hold it securely against the abutment portion.

The suture recovery means according to this aspect of the present invention may include any suitable arrangement for drawing a suture through the passage in the suture securing device. The suture recovery means may include a snare shaped to pass through the passage in the 9707i 8 suture securing device and retractable through said passage such that when said snare is passed through said passage and a section of suture is snared, the snare may be retracted through said passage bringing with it a loop of said suture.

The snare may include a loop of filament.

The suture recovery means may then be capable of being disengaged from the loop of suture drawn through the suture securing device. Accordingly the snare may be attached to a member removably connectable to a retractable shaft, and is severable from said member when said shaft is retracted along said apparatus such that the snare is disengageable from said loop of suture recovered through the bore when the shaft is retracted along said apparatus.

In another embodiment the suture recovery means includes a securable thread attached to a disposable member attachable to a shaft, the thread being frangibly attached to the shaft. The suture recovery means may be automated to load the loop of suture and sever the thread in one action by actuating a lever or the like.

Sn a l furtho aspect of the present invention there is provided a method of securing a suture at a desired surgical site including providing a suture securing device for intracorporeally securing a suture including; a surgically implantable body having a s tissue abutting side and a suture loop side; and a first suture passage extending through the 9 body, said passage extending from an opening in the tissue abutting side to an opening in the suture loop side; said passage being shaped such that when a loop of suture is positioned within the passage and extending beyond the suture loop side and a free end of suture is passed through said loop, the loop clamps upon the fee end when said loop is retracted back into said passage; a delivery apparatus including an elongate hollow body at one end releasably engaging said suture securing device; a suture recovery means within said elongate hollow body adapted to draw a loop suture through the first suture passage; o and a suture clamping means within said elongate hollow body, adapted to securely engage suture which has been passed through the loop in said suture securing device; "delivering said suture securing device to the desired surgical site; and o retracting the clamping means to draw the suture taut about said suture securing device.

The method may further include retracting the suture recovery means to disengage the suture loop; and retracting the delivery apparatus to disengage 9707i 10 said suture securing device.

I- willn-ft-ew- be -Onenient- tn -pqr-ri he the invention in more etail with reference to a preferred embodiment illustrated in accompanying drawings. It is to be understood that the d ngs and following description relate to a preferred embodiment and are not intcndcd to limit the cpe of the preent invento, Figure 1 is a side elevation of a delivery apparatus according to the present invention.

Figure 2 is a plan of portion of the member of Figure 8 which holds the suture securing device.

Figure 3 is a side elevation of a suture clamping means according to this aspect of the present invention.

Figure 4 is a plan view of the delivery apparatus of Figure 3.

Figure 5 is a plan view of a suture recovery means oo according to this aspect of the present invention.

Figure 6 is a side elevation of the suture S* recovery means of Figure Figure 7 is a detailed view of the suture recovery means within the delivery apparatus.

Figures 8 to 12 are plan views of the delivery apparatus of the invention at various stages of operation.

0 Figure 13 is a plan view of a delivery apparatus shown holding a suture securing device.

Figure 14 is a plan view of the apparatus in 0 Figure 13 at the point of release.

Figure 15 is a plan view of the apparatus with the S ram retracted.

S/ o 0Y, Figure 16 is a perspective view of a portion of 11 the ram showing its end section.

As illustrated in Figure 1 and 2 delivery apparatus 1 comprises an elongate hollow body 2 having at one end a handle 3. Handle 3 is configured to allow a surgeon to easily manipulate the delivery apparatus 1 during surgery. At the other end of elongate member 2 there is provided projecting member 4 adapted to hold a suture securing device i. Projecting member 4 includes a pair of tines 6, 6a having lugs 7 and 7a adapted to locate in corresponding recesses in device i. Elongate hollow body 2 is suitably configured for use in endoscopic surgery i.e. at least a portion of elongate body 2 is capable of being passed down a portal to the desired .i operating site. Tines 6 and 6a are resiliently biased 15 towards a position where they firmly engage a suture ooe

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securing device 1 positioned therebetween.

As illustrated in Figures 3 and 4, the delivery apparatus 1 further includes a suture clamping means 8.

Clamping means 8 consists of two cooperating members 9 and 20 10 which co-act to grasp and firmly hold a suture which has been passed between clamp face 11 on member 10 and clamp face 12 on member 9, Cooperating member 9 is an elongate tubular body with a partial cut-away end 13.

Cooperating member 10 is accommodated in an axial bore through member 9. Clamp face 11 may be a tongue on member adapted to bear upon clamp face 12 of member 9. Suture clamping means 8 further includes an actuating mechanism 13a and capable of moving clamp faces 11 and 12 relative to each other to clamp a suture passed between the faces.

Actuating mechanism 13a includes a lever 14, which, when 9707i 12 depressed by the surgeon moves cooperating members 9 and relative to each other and brings clamp faces 11 and 12 together. Suture clamping means 8 is positioned within elongate hollow body 2. The suture clamping means further includes incising edge 34 as discussed below.

As illustrated in Figures 5, 6 and 7, delivery apparatus 1 further includes a suture recovery means adapted to draw a loop of suture through the suture passage in suture securing device. Sutureks-fe means consists of a shaft 16 positioned within suture clamping means 8. Shaft 16 is connected to a replaceable head via coupling means 17. Coupling means 17 consists of a finger 18 which projects from the end of shaft 16 and lug 19. Replaceable head 20 includes a recess 22 adapted to receive coupling means 17. A frangible loop 24 is attached to head 20 such that when the suture snare is retracted into the bore, frangible loop 24 is severed.

Loop 24 may be severed by a scissor action between the head portion 20 and an incising edge 34 at bore opening of 20 suture clamping means 8. The suture recovery means 15 is configured such that shaft 16 cannot be fully retracted from apparatus 1 during use and stops such that the tip of head portion 20 is retained within the bore such that the eeo• gas seal is not broken. The snare loop 24 may be formed of any suitable flexible material. Snare loop 24 may itself be made of suture material.

In the embodiment of the invention shown in Figures 13 to 16 tines 6 and 6a carry cams 31 and 32 which interact with ram 33 at the end of a shaft 35. When a SRlunger or other actuating means at the handle end (not plunger or other: actuating means at the handle end (not 13 shown) of the delivery apparatus is actuated, force is transmitted along shaft 35 to drive ram 33 onto cams 31 and 32 as shown in Figure 14. Tines 6 and 6a and hence lugs 7 and 7a are forced apart to disengage from corresponding recesses in device la. A section of ram 33 is illustrated in Figure 16. Ram 33 has cam grooves 36 and 36a such that ram 33 positively engages cams 31 and 32 when actuated.

Figures 8 to 12 illustrate the positioning a suture securing device la at a desired surgical site.

Where a single suture securing device la is shown with one end 26a of a suture 26 securely affixed thereto and emerging from said device adjacent a tissue abutting face 27. The free end of the suture terminates in a suturing needle 29. In a preferred embodiment, suture securing device la is provided with suture 26 attached and with frangible loop 24 pre-positioned through suture passage Once suturing has been completed needle 29 is passed through the frangible loop 24 as shown in Figure 20 8. Suture 26 is then drawn through passage 30 as shown in Figure 9 by retracting the suture recovery means 15 until oi a loop of suture 32 emerges on the apparatus side of device la. Suture loop 24 is drawn until it is adjacent clamp faces 11 and 12. Further retraction of suture recovery means 15 severs snare loop 24 against incising edge 34.

Needle 29 is then passed through suture loop 24 and between clamp faces 11 and 12 as shown in Figure By depressing actuating lever 14, clamp faces 11 and 12 clamp the suture as shown in Figure 11. Suture clamping 9707i I 14 means 8 may then be retracted relative to device la to tension suture 26, as shown in Figure 12. Finally, in order to position suture securing device la at the desired site, delivery apparatus 2 is pushed towards the desired site whilst suture clamping means 8 draws slack suture through device la towards the tissue against which it is to hold the suture 26. Once at the desired site, the elongate body 2 can be retracted and the secure hold of device la enables tines 6 and 6a to release the device when retracted. Excess suture material can then be severed.

If the suture securing device la is to secure only one end of suture 26, the device need not be provided with .the pre-attached suture as previously described. The suture securing device la need only be provided with one *bore.

The delivery apparatus 1 may further be utilized to position a suture securing device 1 for ligation of a vessel, organ, duct, tissue or the like. A suture 20 securing device la may be provided pre-tied with a suture and loaded into apparatus 1 in the form shown in Figure The suture 26 need not be provided with a needle.

The loop of suture emerging from the tissue abutting side .oe.

of the device la may simply be slipped around the tissue, •go oI vessel, organ, duct or the like in a lasso fashion, rather than being passed through the tissue as shown in Figure 11. The device la may be positioned to ligate the desired site in a manner identical to that described above, i.e.

by clamping the free end of the suture between clamp faces 11 and 12.

9707i 15 Preferably, suture recovery means 15 and suture clamping means 8 are located within the elongate hollow body 2.

In the embodiment as shown in Figures 12, 14, and 16, the apparatus may be provided without integral suture snare means and/or suture clamping means. If provided without such means, the suture may be threaded about the device using suitable conventional surgical instruments. If provided with such means, preferably the holding member, suture recovery means and suture clamping means are supplied as an integral unit capable of insertion down a single port for endoscopic surgery.

The delivery apparatus may be made from any suitable materials by any suitable method. Preferably, 15 the elongate hollow body 2, suture clamping means 8 and shaft 16 are made from surgical steel which can be sterilized and re-used a number of times. Head 20 may be disposable and made from a suitable sterilizable polymeric material. The snare loop may be any suitable flexible 20 wire, filament or the like. Preferably when a disposable head is used and the loading loop is to be separable, the loading loop is made from a narrow gauge suture material or the like.

It will be appreciated that various modifications, oI additions and/or alterations may be made to the apparatus previously described without departing from the ambit of the present invention.

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Claims (14)

1. An apparatus for delivering a suture securing device to a desired surgical site, including an elongate hollow body adapted at one end to releasably engage said suture securing device; a suture recovery means within said elongate hollow body adapted to draw a loop of suture through o- first suture passage of the suture securing device; and a suture clamping means within said elongate hollow body, adapted to securely engage suture which has been passed through the loop in said suture securing device.

2. A delivery apparatus according to claim 1 wherein the elongate hollow body includes a projecting member at one end adapted to releasably engage with a corresponding locating means on the suture securing device.

3. A delivery appartus according to clai I erein the projecting member includes a pair of arms adapted to engage corresponding locating recesses in the suture 20 securing device.

4. A suture securing apparatus according to claim 3 wherein the arms include tines resiliently biased towards engagement with the suture securing device.

A delivery apparatus according to any one of claims 1 to 4 wherein the elongate hollow body includes a handle at its other end.

6. A delivery apparatus according to claim 5 where said suture recovery means and/or said suture clamping means are actuated in the region of said handle. 3-7"

7. A delivery apparatus according to any one of 17 claims 1 to 6 wherein the suture recovery means and/or suture clamping means are retractable along the length of the elongate body.

8. A delivery suture securing apparatus according to any one of claims 1 to 7 wherein said suture clamping means includes an abutment portion and a tongue member adapted to bear upon the abutment portion such that when a suture is passed through the loop, the tongue is pressed against the suture to hold it securely against the abutment portion.

9. A delivery apparatus according to any one of claims 1 to 8 wherein the suture recovery means includes a snare shaped to pass through the passage in the suture securing device and retractable through said passage such 15 that when said snare is passed through said passage and a section of suture is snared, the snare may be retracted through said passage bringing with it a loop of said suture.

10. A delivery apparatus according to claim 9 wherein 20 the snare includes a loop of filament.

11. A delivery apparatus according to claim 10 wherein the snare is attached to a member removably connectable to a retractable shaft, and is severable from said member when said shaft is retracted along said apparatus such that the snare is disengageable from said loop of suture recovered through the bore when the shaft is retracted along said apparatus.

12. A method of securing a suture at a desired surgical site including providing 9707i 18 a suture securing device for intracorporeally securing a suture including; a surgically implantable body having a tissue abutting side and a suture loop side; and a first suture passage extending through the body, said passage extending from an opening in the tissue abutting side to an opening in the suture loop side; said passage being shaped such that when a loop of suture is positioned within the passage and extending beyond the suture loop side and a free end of suture is passed through said loop, the loop clamps upon the 15 free end when said loop is retracted back into said passage; a delivery apparatus including an elongate hollow body at one end releasably engaging said suture 20 securing device; a suture recovery means within said elongate hollow body adapted to draw a loop of suture through the first suture passage; and a suture clamping means within said elongate hollow body, adapted to securely engage suture which has been passed through the loop in said suture securing device; delivering said suture securing device 9707i .I 4 1 19 to the desired surgical site; and retracting the clamping means to draw the suture taut about said suture securing device.

13. A method according to claim 12 further including retracting the suture recovery means to disengage the suture loop; and retracting the delivery apparatus to disengage said suture securing device.

14. A delivery apparatus according to claim 1 substantially as hereinbefore described with reference to the accompanying drawings. DATED 17 November, 1993. o ATTORNEYS FOR: AT AMBR.-ICAN CYAMID COMPANY Arcfex Cicorso icnl Inc. n 20 9707i SEC. 9707i IL~ P ABSTRACT An apparatus for delivering a suture securing device to a desired surgical site, including an elongate hollow body adapted at one end to releasably engage said suture securing device; a suture recovery means within said elongate hollow body adapted to draw a loop of suture through the first suture passage of the suture securing device; and a suture clamping means within said elongate hollow body, adapted to securely engage suture which has been passed through the loop in said suture securing device. a 9707i