A suture arrangement and method of suturing

Abstract

The present disclosure relates to a suture arrangement and a method of suturing using the suturing arrangement. The suture arrangement comprises a plurality of suture portions, three or more needles comprised of two outer needles and one or more inner needles, and three or more pledgets comprised of two outer pledgets and one or more inner pledgets. In use, the three or more needles are inserted through a first material and a second material. The needles are cut away from the plurality of suture portions to create a plurality of free suture portion ends. The free suture portions of adjacent pair of sutures are then fixed together, connecting the first material and second material together.

Description

[0001] A SUTURE ARRANGEMENT AND METHOD OF SUTURING

[0002] Field of the Invention

[0003] [1] The present invention relates to a suture arrangement and method of suturing capable of use in a wide variety of medical and veterinary suturing applications.

[0004] [2] One of these applications is human heart surgery and the invention will primarily be described hereinafter with reference to this application. It will, however, be appreciated that the invention is not limited to this particular application or field of use.

[0005] Background of the Invention

[0006] [3] Suturing is a critical surgical technique in both human and veterinary medicine, employed for the closure of wounds, anastomosis of tissues, and management of surgical incisions. In human medicine, suturing is integral to various specialties, including general surgery, orthopedics, and trauma surgery, where precise closure of tissue layers is essential for optimal healing and minimizing complications such as infection or dehiscence.

[0007] [4] In veterinary practice, suturing techniques are similarly vital for managing a wide range of surgical and traumatic injuries across species. The principles of suturing — tension distribution, tissue approximation, and the prevention of necrosis — are universally applicable, though the specific approaches may differ due to variations in anatomy and physiology among species.

[0008] [5] Key considerations in both domains include suturing material, technique, choice of knots and time to apply and fix the sutures.

[0009] [6] A standard surgical approach for a heart valve replacement involves the following four steps: 1) valve resection - removing existing diseased heart valve and preparing valve annulus to receive a new prosthetic valve; 2) annular suture placement - placing a series of mattress sutures neatly next to each other around the entire annulus; 3) prosthetic valve suture placement - passing the same sutures already placed on the annulus one by one through a prosthetic valve sewing ring; and 4) prosthetic valve implantation - parachuting the prosthetic valve onto the annulus and securing the sutures either with hand-tie knots or a suture crimping device.

[0010] [7] In this standard surgical approach, 15 to 21 sutures with 30 to 42 needles are usually used for each valve replacement, which equates to 60-82 needle handling maneuvers (performing step 2 and step 3 using 30 - 42 needles) per case. [8] The period of time taken by a surgeon to apply sutures is often a significant component of the overall operative time. With each suture requiring two needles to be passed through each of two materials (such as the sewing ring and aortic annulus), at very precise locations, along with the simultaneous management of suture lines, typically by the surgeon’s assistant, the overall process of suturing is both demanding and time-consuming work. The patient is required to remain under cardiopulmonary bypass until the surgery is complete so the longer the suturing takes, the longer the patient must be under cardiopulmonary bypass. Studies show that prolonged cardiopulmonary bypass times are associated with increased risk of complications and / or death. Therefore, there is need to reduce the time taken by components of the overall operative time, including the time taken to apply and fix sutures.

[0011] [9] Furthermore, it may be onerous for surgeons to handle many needles and sutures while operating together with an assistant or otherwise. The higher the number of sutures and / or needles, the higher the risk of erroneous or unintended stitching or knotting. Furthermore, the higher the number of sutures and / or needles, the higher the risk of inadvertently losing or dropping a needle or suture, or associated device such as a pledget, within the body or organ during the operation.

[0012]

[0010] The present invention seeks to provide a suture arrangement and a method of suturing, which will overcome or substantially ameliorate at least some of the deficiencies of the prior art, or to at least provide an alternative.

[0013]

[0011] It is to be understood that, if any prior art information is referred to herein, such reference does not constitute an admission that the information forms part of the common general knowledge in the art, in Australia or any other country.

[0014] Summary of the Invention

[0015]

[0012] According to a first aspect of the present invention, a suture arrangement is provided, the suture arrangement comprising: a plurality of suture portions, each suture portion having two suture end regions; three or more needles comprising two outer needles and one or more inner needles, and each needle having a suture connecting end region; and three or more pledgets comprising two outer pledgets and one or more inner pledgets, each of two outer pledgets comprising a through-aperture and each of the one or more inner pledgets comprising one or more through-apertures; wherein: (i) each of the one or more inner needles has a suture connecting end region that is connected to one of the two suture end regions of each of two suture portions of the plurality of suture portions;

[0016] (ii) each of the two outer needles has a suture connecting end region that is connected to one of the two suture end regions of one suture portion of the plurality of suture portions;

[0017] (iii) each group of two adjacent needles of the three or more needles have suture connecting end regions that are connected by a common suture portion of the plurality of suture portions;

[0018] (iv) each of the suture portions that connect to any one of the one or more inner needles extend through one of the one or more through-apertures of a respective one of the one or more inner pledgets; and

[0019] (v) each suture portion that connects to an outer needle of the two outer needles extends through the through-aperture of the respective outer pledget of the two outer pledgets.

[0020]

[0013] In the prior art, when two suture lines pass through a target tissue and the needle is cut off, the two suture lines are pulled apart to tie or crimp the suture free ends. The pulling and the subsequent knotting or crimping of the suture lines can cause the suture lines to apply a stretching force to the suture hole. This may cause the suture hole to be pulled apart and enlarged. This, in turn, may be detrimental to wound healing and may cause blood leakage, particularly if a pressure differential exists through the suture hole.

[0021]

[0014] Advantageously, the configuration of the present invention above allows the one or more pledgets to abut the suture hole and to therefore counteract most or all of the stretching force applied to the suture hole when the suture portions are pulled apart, knotted, crimped or cut. The one or more pledgets also distribute the forces applied by the suture portions to the suture hole over a wider surface area of the surrounding tissue. This may lessen the contact and tension between the tissue and the suture portions. Embodiments of the present invention, therefore, may reduce the risk of enlarging or pulling apart of the tissue when the suture portions are being pulled.

[0022]

[0015] Furthermore, in embodiments of the invention, the reduction of force applied to the suture holes may allow suture holes to be made further apart from each other, for example, up to a spacing of 10mm apart. This, in turn, may reduce the number of suture holes and suture portions required to complete a surgery.

[0016] In the prior art, pledgets are located substantially in-between the suture holes such that in use (when the sutures are pulled apart, knotted, crimped or cut) the pledgets do not align with the suture holes produced. After a first needle is passed through a material (e.g. a tissue), the passing of a second needle through a material often causes the suture portions to twist, which, in turn, results in the pledget twisting under the material. This requires the surgeon to manually intervene to untwist the suture portions. In the present invention, as the pledgets are substantially or directly in-line with the suture portions, twisting is avoided.

[0023]

[0017] Furthermore, once the sutures are in place, interlocking of pledgets can occur which may further aid in reducing bleeding and / or hemostasis.

[0024]

[0018] In one embodiment, each of the one or more inner pledgets comprises one through- aperture which receives both of the suture portions that are connected to one of the one or more inner needles.

[0025]

[0019] Advantageously, providing each of the one or more inner pledgets with only one through-aperture means that the radial wall thickness of each of the one or more inner pledgets is greater than if it comprised more than one through-aperture. Since the radial wall thickness of each pledget is wider, it would require greater pulling force from the suture portion to tear or break the pledget. Thus, providing each of the one or more inner pledgets with only one through-aperture makes each pledget more resistant to breaking.

[0026]

[0020] In one embodiment, each of the one or more inner pledgets comprises two through- apertures and each aperture of the two through-apertures receives a single suture portion through it.

[0027]

[0021] In one embodiment, each suture portion of the plurality of suture portions is coloured in one of two colours and the colour of adjacent suture portions alternates between the two colours.

[0028]

[0022] Advantageously, it may be easier for the user, for example a surgeon or their assistant, to distinguish which suture end region belongs to a specific suture and to distinguish the sutures from each other. Furthermore, it may be clearer to the user which suture end regions should be knotted, tied or otherwise fixed together.

[0029]

[0023] In one embodiment, the plurality of suture portions are portions of a continuous, single suture.

[0030]

[0024] In one embodiment, each pledget of the three or more pledgets comprises: a disc shaped body, the body having a first circular face and a second circular face; and one or more through-apertures extending from at least a portion of the first circular face through to at least a portion of the second circular face, wherein each through-aperture of the one or more through-apertures is adapted to receive one or more suture portions of the suture arrangement.

[0031]

[0025] Advantageously, the disc shape of the body allows one or more suture portions to readily unravel or untwist when the one or more suture portions are tangled because the disc shaped body of the pledget will rotatably slide over the outer perimeter of the sewing ring (or other material) more easily than if the body of the pledget was non-symmetrical (such as ovalshaped).

[0032]

[0026] Advantageously, rounded disc pledget will untwist as they do not have edges that might catch on a material (e.g. a tissue).

[0033]

[0027] In one embodiment, the pledget has a diameter of 3mm and a thickness of 1-2mm.

[0034]

[0028] In one embodiment, the one or more through-apertures is two through-apertures, and the distance between a centre of one of the two through-apertures and a centre of the other one of the two through-apertures is about 1mm.

[0035]

[0029] According to a further aspect of the present invention, a method for suturing using the suture arrangement above is provided, the method comprising the steps of: inserting the three or more needles through a first material and a second material; cutting the three or more needles away from the plurality of sutures to create a plurality of free suture portion ends; pairing the plurality of free suture portion ends such that each pair comprises one suture portion that was cut from a first needle of the three or more needles and the one suture portion that was cut from an adjacent needle of the three or more needles; and fixing the suture portions of each pair of sutures together.

[0036]

[0030] In one embodiment, after the three or more needles are inserted through the first material and the second material, the second material is brought into contact with the first material by progressing a portion of the length of the sutures through it.

[0037]

[0031] In one embodiment, the first material is the annulus region of a heart valve and the second material is a sewing ring of a prosthetic heart valve.

[0038]

[0032] In one embodiment, the free suture portion ends of each pair are fixed together by any one of the following fixing methods:

[0039] (i) a hand tied knot; or (ii) a crimping device.

[0040]

[0033] According to a further aspect of the present invention, a pledget for a suture arrangement is provided, the pledget comprising: a disc shaped body, the body having a first circular face and a second circular face; and one or more through-apertures extending from at least a portion of the first circular face through to at least a portion of the second circular face, wherein each through-aperture of the one or more through-apertures is adapted to receive one or more suture portions of the suture arrangement.

[0041]

[0034] Advantageously, the disc shape of the body allows one or more suture portions to readily unravel or untwist when the one or more suture portions are tangled because the disc shaped body of the pledget will rotatably slide over the outer perimeter of the sewing ring more easily than if the body of the pledget was non-symmetrical (such as oval-shaped).

[0042]

[0035] In one embodiment, the pledget has a diameter of 3mm and a thickness of 1-2mm.

[0043]

[0036] In one embodiment, the one or more through-apertures is two through-apertures, and the distance between a centre of one of the two through-apertures and a centre of the other one of the two through-apertures is about 1mm.

[0044]

[0037] In one embodiment, the one or more through-apertures is one through-aperture having a diameter of about 1 mm and being concentric with the first and second circular faces.

[0045]

[0038] Advantageously, providing the pledget with only one through-aperture means that the radial wall thickness of the pledget is greater than if there were more than one through- aperture. Since the radial wall thickness of the pledget is wider, it would require greater pulling force from the suture portion(s) to tear or break the pledget. Thus, providing the pledgets with only one through-aperture makes the pledget more resistant to breaking.

[0046]

[0039] This invention may also be said broadly to comprise in the parts, elements, and features referred to or indicated in the specification of the application, individually or collectively, and any or all combinations of any two or more of said parts, elements, or features, and where specific integers are mentioned herein which have known equivalents in the art to which this invention relates, such known equivalents are deemed to be incorporated herein as if individually set forth.

[0047]

[0040] To those skilled in the art to which the invention relates, many changes in construction and widely differing embodiments and applications of the invention will suggest themselves without departing from the scope of the invention as defined in the appended claims. The disclosures and the descriptions herein are purely illustrative and are not intended to be in any sense limiting.

[0048]

[0041] Other aspects of the invention are also disclosed.

[0049] Brief Description of the Drawings

[0050]

[0042] Notwithstanding any other forms which may fall within the scope of the present invention, a preferred embodiment of the invention will now be described, by way of example only, with reference to the accompanying drawings in which:

[0051]

[0043] Figure 1 A shows an illustration of a first embodiment of a suture arrangement including a plurality of pledgets;

[0052]

[0044] Figure 1 B shows a magnified view of the suture arrangement of Fig. 1A;

[0053]

[0045] Figure 2 shows a schematic diagram of the suture arrangement of Fig. 1A being applied to an aortic annulus and a sewing ring;

[0054]

[0046] Figure 3 shows a schematic diagram the suture arrangement of Fig. 2 being knotted;

[0055]

[0047] Figure 4 shows an illustration of the suture arrangement of Fig. 1 A being applied to an aortic annulus;

[0056]

[0048] Figure 5 shows an illustration the suture arrangement of Fig. 1 A being applied to suture a sewing ring to a prosthetic valve conduit;

[0057]

[0049] Figure 6A shows an illustration of a second embodiment of a suture arrangement including a plurality of pledgets;

[0058]

[0050] Figure 6B shows a magnified view of the suture arrangement of Fig. 6A;

[0059]

[0051] Figure 7 shows a schematic diagram of the suture arrangement of Fig. 6A being applied to an aortic annulus and a sewing ring;

[0060]

[0052] Figure 8 shows a schematic diagram the suture arrangement of Fig. 7 being knotted;

[0061]

[0053] Figure 9 shows an illustration of the suture arrangement of Fig. 6A being applied to an aortic annulus;

[0062]

[0054] Figure 10 shows an illustration the suture arrangement of Fig. 6A being applied to suture a sewing ring to a prosthetic valve conduit;

[0063]

[0055] Figure 11 shows an illustration of the disc-shaped pledget of the plurality of pledgets as shown in Fig. 1A; and

[0056] Figure 12A shows an illustration of a third embodiment of a suture arrangement including a plurality of pledgets; and

[0064]

[0057] Figure 12B shows a magnified view of a suture arrangement of Fig. 12A.

[0065] Description of Embodiments

[0066]

[0058] It should be noted in the following description that like or the same reference numerals in different embodiments denote the same or similar features.

[0067]

[0059] Figs. 1A-1 B show a suture arrangement 1000 of the present invention. The suture arrangement 1000 comprises a plurality of needles 1100 and a plurality of suture portions 1200. The plurality of needles 1100 include a first outer needle 1110, a second outer needle 1120, and a plurality of inner needles 1130. As shown in the embodiment of Figs. 1A-1 B, the plurality of inner needles 1130 comprise a first inner needle 1131 , a second inner needle 1132, a third inner needle 1133, a fourth inner needle 1134, a fifth inner needle 1135, a sixth inner needle 1136, a seventh inner needle 1137, an eight inner needle 1138 and a ninth inner needle 1139. The plurality of suture portions 1200 include a first suture portion 1201 , a second suture portion, 1202, a third suture portion 1203, a fourth suture portion 1204, a fifth suture portion 1205, a sixth suture portion 1206, a seventh suture portion 1207, an eight suture portion 1208, a ninth suture portion 1209 and a tenth suture portion 1210. Each of the plurality of suture portions 1200 comprises a first end region 1220 and a second end region 1230.

[0068]

[0060] Each of the plurality of needles 1100 comprises a suture connecting end region 1140 configured to connect to at least a corresponding one of the plurality of suture portions 1200. As shown in Figs. 1A-1 B, the connecting end region 1140 of the first outer needle 1110 is connected to the first end region 1220 of the first suture portion 1201. The connecting end region 1140 of the first inner needle 1131 is both connected to the second end region 1230 of the first suture portion 1201 and the first end region 1220 of the second suture portion 1202. The connecting end region of the second inner needle 1132 is connected to both the second end region 1230 of the second suture portion 1202 and the first end region 1220 of the third suture portion 1203. The connecting end region of the third inner needle 1133 is connected to both the second end region 1230 of the third suture portion 1203 and the first end region 1220 of the fourth suture portion 1204. The connecting end region of the fourth inner needle 1134 is connected to both the second end region 1230 of the fourth suture portion 1204 and the first end region 1220 of the fifth suture portion 1205. The connecting end region of the fifth inner needle 1135 is connected to both the second end region 1230 of the fifth suture portion 1205 and the first end region 1220 of the sixth suture portion 1206. The connecting end region of the sixth inner needle 1136 is connected to both the second end region 1230 of the sixth suture portion 1206 and the first end region 1220 of the seventh suture portion 1207. The connecting end region of the seventh inner needle 1137 is connected to both the second end region 1230 of the seventh suture portion 1207 and the first end region 1220 of the eighth suture portion 1208. The connecting end region of the eighth inner needle 1138 is connected to both the second end region 1230 of the eighth suture portion 1209 and the first end region 1220 of the ninth suture portion 1209. The connecting end region of the ninth inner needle 1139 is connected to both the second end region 1230 of the ninth suture portion 1209 and the first end region 1220 of the tenth suture portion 1210. Finally, the connecting end region of the second outer needle 1120 is connected to the second end region 1230 of the tenth suture portion 1210.

[0069]

[0061] In this arrangement, the first and second outer needles 1110 and 1120, and the inner needles 1130 are connected in sequence through the common suture portions of the plurality of suture portions 1200. This means that each of the inner needles 1130 connected to the respective suture portions, perform the function of passing two suture portions through the material, instead of one. In an application that required X number of suture portions, the present suture arrangement would only require X+1 number of needles.

[0070]

[0062] As shown in Figs. 1A-1 B, the suture arrangement is provided with a plurality of pledgets 1300. In the embodiment as shown, the plurality of pledgets 1300 comprises a first outer pledget 1301 , a second outer pledget 1302, a first inner pledget 1303, a second inner pledget 1304, a third inner pledget, 1305, a fourth inner pledget 1306, a fifth inner pledget 1307, a sixth inner pledget 1308, a seventh inner pledget 1309, an eighth inner pledget 1310 and a ninth inner pledget 1311. All the outer pledgets 1301 , 1302 and the inner pledgets 1303- 13011 comprise a disc shaped body having a first circular face and a second circular face. The outer pledget 1301 comprises a through-aperture extending from at least a portion of the first circular face through to at least a portion of the second circular face, wherein the through- aperture is adapted to allow a portion of the first suture portion 1201 to extend therethrough. The outer pledget 1302 comprises a through-aperture extending from at least a portion of the first circular face through to at least a portion of the second circular face, wherein the through- aperture is adapted to allow a portion of the tenth suture portion 1210 to extend therethrough.

[0071]

[0063] Each inner pledget 1303 to 1311 comprises a disc shaped body having a first circular face and a second circular face. Each inner pledget comprises one or more through-apertures extending from at least a portion of the first circular face through to at least a portion of the second circular face, through which respective suture portions extend. In this embodiment:

[0072] • a first suture portion second region and a second suture portion first region extend through a first inner pledget 1303 through-aperture; • a second suture portion second region and a third suture portion first region extend through a second inner pledget 1304 through-aperture;

[0073] • a third suture portion second region and a fourth suture portion first region extend through a third inner pledget 1305 through-aperture;

[0074] • a fourth suture portion second region and a fifth suture portion first region extend through a fourth inner pledget 1306 through-aperture;

[0075] • a fifth suture portion second region and a sixth suture portion first region extend through a fifth inner pledget 1307 through-aperture;

[0076] • a sixth suture portion second region and a seventh suture portion first region extend through a sixth inner pledget 1308 through-aperture;

[0077] • a seventh suture portion second region and an eighth suture portion first region extend through a seventh inner pledget 1309 through-aperture;

[0078] • an eighth suture portion second region and a ninth suture portion first region extend through an eighth inner pledget 1310 through-aperture; and

[0079] • a ninth suture portion second region and a tenth suture portion first region extend through a ninth inner pledget 1311 through-aperture.

[0080]

[0064] This embodiment allows the pledgets 1300 to abut respective suture holes and to therefore counteract most or all of the stretching force applied to the suture holes when the suture portions are pulled apart, knotted, crimped or cut. The pledgets 1300 also distribute the forces applied by the suture portions to respective suture holes over a wider surface area of the surrounding tissue. Embodiments of the present invention, therefore, may reduce the risk of enlarging or pulling apart of the tissue when the suture portions are being pulled.

[0081]

[0065] In another embodiment, each of the inner pledgets 1303, 1304, 1305, 1306, 1307, 1308, 1309, 1310 and 1311 and each of the outer pledgets 1301 and 1302 have only one through-aperture. Each through-aperture of the inner pledgets and the outer pledgets is concentric with the first circular surface 1331 and the second circular surface1332. In an embodiment, each through-aperture has a diameter of about 1 mm.

[0082]

[0066] In an embodiment, each suture portion of the plurality of suture portions 1200 has an enlarged diameter or width in a region between the pledgets, in use. This aids in distributing load across the surrounding tissue.

[0083]

[0067] In another embodiment, each of the inner pledgets 1303, 1304, 1305, 1306, 1307, 1308, 1309, 1310 and 1311 comprises two through-apertures while the outer pledgets 1301 and 1302 each have only one through-aperture. For each of the inner pledgets, the distance between a centre of a first through-aperture and a centre of a second through-aperture is between 0.5mm and 2mm, but preferably 1mm. In this embodiment, a first region of the first suture portion 1201 extends through the first outer pledget 1301 through-aperture and a second region of the tenth suture portion 1210 extends through the second outer pledget 1302 through-aperture. Further in this embodiment:

[0084] • the first suture portion second region extends through a first through-aperture of the first inner pledget 1303 and the second suture portion first region extends through the second through-aperture of the first inner pledget 1303;

[0085] • the second suture portion second region extends through a first through-aperture of the second inner pledget 1304 and the third suture portion first region extends through the second through-aperture of the second inner pledget 1304;

[0086] • the third suture portion second region extends through a first through-aperture of the third inner pledget 1305 and the fourth suture portion first region extends through the second through-aperture of the third inner pledget 1305;

[0087] • the fourth suture portion second region extends through a first through-aperture of the fourth inner pledget 1306 and the fifth suture portion first region extends through the second through-aperture of the fourth inner pledget 1306;

[0088] • the fifth suture portion second region extends through a first through-aperture of the fifth inner pledget 1307 and the sixth suture portion first region extends through the second through-aperture of the fifth inner pledget 1307;

[0089] • the sixth suture portion second region extends through a first through-aperture of the sixth inner pledget 1308 and the seventh suture portion first region extends through the second through-aperture of the sixth inner pledget 1308;

[0090] • the seventh suture portion second region extends through a first through-aperture of the seventh inner pledget 1309 and the eighth suture portion first region extends through the second through-aperture of the seventh inner pledget 1309;

[0091] • the eighth suture portion second region extends through a first through-aperture of the eighth inner pledget 1310 and the ninth suture portion first region extends through the second through-aperture of the eighth inner pledget 1310; and

[0092] • the ninth suture portion second region extends through a first through-aperture of the ninth inner pledget 1311 and the tenth suture portion first region extends through the second through-aperture of the ninth inner pledget 1311.

[0068] As shown in Fig. 11 , each pledget of the plurality of pledgets 1300 has a disc shaped body, the body having a first circular face 1331 and a second circular face 1332. Each pledget likewise has two through-apertures 1333, 1334 extending from at least a portion of the first circular face 1331 through to at least a portion of the second circular face 1332. Each through- aperture of the two through-apertures is adapted to receive one or more suture portions of the suture arrangement as provided in the abovementioned configuration.

[0093]

[0069] Each pledget of the plurality of pledgets 1300 has a diameter of 3 millimetres and a thickness of 1-2mm. The distance between a centre of one of the two through-apertures and a centre of the other one of the two through-apertures is about 1mm.

[0094]

[0070] In an embodiment, each of the suture portions 1200 is the same length. The length of the suture portions and the material of the suture portions will be determined based on the type of surgery being performed.

[0095]

[0071] In other embodiments, the number of needles and corresponding suture portions may be varied to more than or less than those shown in this embodiment.

[0096]

[0072] In this embodiment, each suture portion of the plurality of suture portions 1200 is coloured in one of two colours (in this case, blue and white), and the colour of adjacent suture portions of the plurality of suture portions 1200 alternates between the two colours. Therefore, in this embodiment the suture portions follow a “blue - white - blue - white” pattern. The alternation in colours may allow the user, for example a surgeon or their assistant, to distinguish which suture end region belongs to a specific suture portion and to distinguish the suture portions from one another.

[0097]

[0073] Figs. 2 and 4 shows a method of suturing using the suture arrangement 1000. In this specific embodiment, the suture arrangement is applied to an aortic annulus 2000 and a sewing ring 3000. In the embodiment as shown in Fig. 2, the plurality of inner needles includes the first inner needle 1131 , the second inner needle 1132, the third inner needle 1133 and the fourth inner needle 1134, and the plurality of suture portions 1200 includes the first suture portion 1201 , second suture portion 1202, third suture portion 1203, fourth suture portion 1204, and the fifth suture portion 1205. In this embodiment, the second outer needle 1120 is adjacent the fourth outer inner needle 1134, and the connecting end region of the second outer needle 1120 is connected to the second end region of the fifth suture portion 1205. While Fig. 2 only shows four inner needles 1130 and five suture portions 1200, it is to be appreciated that more inner needles 1130 and suture portions 1200 can be applied depending on the size of the annulus and / or sewing ring. As shown in Figs. 2 and 4, each needle of the plurality of needles 1100 is inserted through a corresponding portion of a first surface region 2010 of the aortic annulus 2000 to create corresponding suture holes, and extends outwardly from a second surface region 2020 of the aortic annulus 2000. Preferably, the plurality of needles 1100 are inserted at a consistent spacing along a circumference defined by the aortic annulus 2000. By implementing the suture arrangement of the present invention, the suture holes can also be further apart than in typical surgery, up to 10mm apart for example, because the tension in the suture portions is supported by the pledgets. This, in turn, may reduce the number of suture holes and suture portions required to complete a surgery.

[0098]

[0074] Each of the plurality of suture portions 1200 is then pulled through such that respective pledgets of the plurality of pledgets 1300 cover and cushion the corresponding suture holes of the annulus 2000. This arrangement counteracts most or all of the stretching force applied to the suture holes when the suture portions are pulled apart, knotted, crimped or cut. The pledgets 1300 also distribute the forces applied by the suture portions to respective suture holes over a wider surface area of the surrounding tissue. As further shown in Fig. 4, a suture organiser 4000 is provided to secure the needles separately from each other while operation is ongoing. The suture organiser 4000 holds adjacent suture portions of the plurality of suture portions 1200 that are connected to a corresponding needle of the plurality of needles 1100.

[0099]

[0075] The plurality of needles 1100 are then inserted through a first surface region 3010 of the sewing ring 3000 and then pulled outwardly from a second surface region 3020 of the sewing ring 3000. The sewing ring 3000 is adapted to be connected to a prosthetic valve conduit 5000 as shown in Fig. 5. In other embodiments, the sewing ring 3000 can be connected to other organs, biological materials or other prosthetic materials or elements. After each needle of the plurality of needles 1100 has been inserted through both the annulus 2000 and the sewing ring 3000, the sewing ring 3000 is brought into contact with the annulus 2000 by progressing a portion of the length of the plurality of suture portions 1200 through it. In other embodiments, the sewing ring 3000 may be brought into contact with the annulus 2000 after having three or more needles are inserted through the sewing ring 3000 and the annulus 2000.

[0100]

[0076] The plurality of needles 1100 are then removed from the corresponding suture portions 1200. This is done by cutting a portion of each of the plurality of suture portions 1200. In other embodiments, the needles may be removed from the suture portions 1200 by other possible means. As shown in Fig. 3, each cut portion of the plurality of suture portions 1200 defines a plurality of free suture portion ends 1400. More specifically, the first suture portion 1201 comprises a first free suture portion end 1401 and a second free suture portion end 1402, the second suture portion 1202 comprises a third free suture portion end 1403 and a fourth free suture portion end 1404, the third suture portion 1203 comprises a fifth free suture portion end 1405 and a six free suture portion end 1406, the fourth suture portion 1204 comprises a seventh free suture portion end 1407 and an eighth free suture portion end 1408, and the fifth suture portion 1205 comprises a ninth free suture portion end 1409 and a tenth free suture portion end 1410. As stated previously, it is to be appreciated that the suture portion arrangement shown in Figs. 2 and 3 may have more or less suture portions 1200 than what is shown therein, which result in a corresponding more or less free suture portion ends 1400 after cutting.

[0101]

[0077] The free suture portion ends 1400 of the same suture portion are then knotted together. As shown in Fig. 3, the first free suture portion end 1401 and the second free suture portion end 1402 of the first suture portion 1201 are tied together, the third free suture portion end 1403 and the fourth free suture portion end 1404 of the second suture portion 1202 are tied together, the fifth free suture portion end 1405 and the six free suture portion end 1406 of the third suture portion 1203 are tied together, the seventh free suture portion end 1407 and the eighth free suture portion end 1408 of the fourth suture portion 1204 are tied together, and the ninth free suture portion end 1409 and the tenth free suture portion end 1410 of the fifth suture portion 1205 are tied together.

[0102]

[0078] In other embodiments, the suture portion ends may be connected in any other suitable way, such as by a crimping device or a thermal weld.

[0103]

[0079] In the embodiment where the suture portions are coloured, each suture portion of the plurality of suture portions 1200 is coloured in one of two colours, and the colour of adjacent suture portions of the plurality of suture portions 1200 alternates between the two colours. The alternation in colours may allow the user, for example a surgeon or their assistant, to distinguish which free suture portion end region belongs to a specific suture portion and to distinguish the suture portions from one another. The user may likewise readily know which free suture portion ends should be knotted, tied or otherwise fixed together. In an embodiment, the free suture portion ends that are adapted to be tied together are fixed together by a hand tied knot or a crimping device, such as a Cor Knot.

[0104]

[0080] In an embodiment not shown, the aortic annulus 2000 is connected to the sewing ring 3000 by the suture arrangement 1000. The sewing ring 3000 is connected to the prosthetic valve conduit 5000.

[0105]

[0081] This embodiment, in comparison to prior art, may have almost a 50% reduction in the number of needles required in typical applications. For example, if an application requires 10 suture portions, typical prior art suturing techniques would require the use of 20 needles. However, the present invention only requires the use of 11 needles to apply 10 suture portions. The reduced number of needles is associated with various benefits.

[0106]

[0082] One benefit of the reduction in needle passes is that surgical time is significantly reduced. This, in turn, may reduce the trauma experienced by the patient and therefore can lead to better post-operative outcomes. Cardiopulmonary bypass time may likewise be reduced in the case that the operation requires this.

[0107]

[0083] In other operations, where an organ transplant is required, such as a kidney transplant operation, reduced surgery time can reduce the risk of ischemic injuries and therefore improve post-operative outcomes.

[0108]

[0084] Another benefit of the suture arrangement 1000 is that since the outer and inner needles are connected through sequential common suture portions, the risk of losing a needle or suture portion or associated device in a body, organ or other vital region is reduced.

[0109]

[0085] In an embodiment shown in Figs. 6A-6B, the present invention comprises a single suture line arrangement 1000’. The single suture line arrangement comprises a plurality of needles 1100’ and a single suture line 1200'. The plurality of needles 1100’ includes a first outer needle 1110’, a second outer needle 1120’, and a plurality of inner needles 1130’. The plurality of inner needles 1130’ may include any necessary number of needles. In this embodiment, the plurality of inner needles 1130’ comprises a first inner needle 113T, a second inner needle 1132’, a third inner needle 1133’, a fourth inner needle 1134’, a fifth inner needle 1135’, a sixth inner needle 1136’, a seventh inner needle 1137’, an eighth inner needle 1138’ and a ninth inner needle 1139’.

[0110]

[0086] The single suture line 1200’ comprises a first outer needle securement region 1210’, a second outer needle securement region 1220’ and a plurality of inner needle securement regions 1230’, wherein the first outer needle securement region 1210’ and the second outer needle securement region 1220’ being located at respective ends of the single suture line 1200’. In the embodiment as shown in Figs. 1A-1 B, the plurality of inner needle securement regions 1230’ comprises a first inner needle securement region 1231’, a second inner needle securement region 1232’, a third inner needle securement region 1233’, a fourth inner needle securement region 1234’, a fifth inner needle securement region 1235’, a sixth inner needle securement region 1236’, a seventh inner needle securement region 1237’, an eighth inner needle securement region 1238’ and a ninth inner needle securement region 1239’.

[0111]

[0087] The single suture line 1200’ further comprises a plurality of suture line length regions 1240’, wherein each suture line length region is defined between an adjacent pair of needle securement regions of the plurality of needle securement regions 1210’, 1220’, 1230’.

[0112]

[0088] In a an embodiment as shown in Figs 8-9, a first suture line length region 1241’ is defined between the first outer needle securement region 1210’ and the first inner needle securement region 1231’, a second suture line length region 1242’ is defined between the first inner needle securement region 1231’ and the second inner needle securement region 1232’, a third suture line length region 1243’ is defined between the second inner needle securement region 1232’ and the third inner needle securement region 1233’, a fourth suture line length region 1244’ is defined between the third inner needle securement region 1233’ and the fourth inner needle securement region 1234’, and a fifth suture line length region 1245’ is defined between the fourth inner needle securement region 1234’ and the second outer needle region 1220’.

[0113]

[0089] Each of the plurality of needles 1100’ comprises a suture connecting end region 1140’ configured to connect to a corresponding needle securement region 1200’. In a specific embodiment, the suture connecting end region 1140’ of the first outer needle 1110’ is connected to the first outer needle securement region 1210’ and the suture connecting end region 1140’ of the second outer needle 1120’ is connected to the second outer needle securement region 1220’. Then, the connecting end region 1140’ of the first inner needle 113T is connected to the first inner needle securement region 1231’, the connecting end region 1140’ of the second inner needle 1132’ is connected to the second inner needle securement region 1232’, the connecting end region 1140’ of the third inner needle 1133’ is connected to the third inner needle securement region 1233’, and the connecting end region 1140’ of the fourth inner needle 1134’ is connected to the fourth inner needle securement region 1234’.

[0114]

[0090] In this arrangement, the first and second outer needles 1110’ and 1120’, and the inner needles 1130’ are connected in sequence through the single suture line. This means that each of the inner needles 1130’ connected to the suture line, perform the function of passing two suture line length regions through the material using a single suture line. In applications that required X sutures, typical prior art suturing techniques require 2X needles to be used. Whereas, in the present invention, a single suture line can be applied with X+1 number of needles.

[0115]

[0091] In this embodiment, the colour of adjacent suture line length regions of the plurality of suture line length regions 1240’ alternates between two colours (in this case, blue and white). Therefore, in this embodiment the plurality of suture line length regions follow a “blue - white - blue- white” pattern. The application of colour on the suture lines may be easier for the user, for example a surgeon or their assistant, to distinguish which suture line length region belongs to a specific needle and to distinguish the suture line length region one from another. Furthermore, it may be clearer to the user which suture line length regions should be knotted, tied or otherwise fixed together. Other contrasting colour pairs can of course be used.

[0116]

[0092] In this embodiment, each of the plurality of suture line length regions 1240’ comprises a corresponding pledget from a plurality of pledgets 1300’. The plurality of pledgets 1300’ includes a first outer pledget 1301’, a second outer pledget 1302’, a first inner pledget 1303’, a second inner pledget 1304’, a third inner pledget 1305’ and a fourth inner pledget 1306’.

[0117]

[0093] Each pledget 130T, 1302’, 1303’, 1304’, 1305’, 1306’ has a disc shaped body having a first circular face and a second circular face. The outer pledget 130T comprises a through- aperture extending from at least a portion of the first circular face through to at least a portion of the second circular face, wherein the through-aperture is adapted to allow a first portion of a first suture line length region 124T to extend therethrough. The outer pledget 1302’ comprises a through-aperture extending from at least a portion of the first circular face through to at least a portion of the second circular face, wherein the through-aperture is adapted to allow a second portion of a fifth line length region 1245’ to extend therethrough. Further in this embodiment:

[0118] • a second portion of the first suture line length region 124T and a first portion of the second suture line length region 1242’ extends through the first inner pledget 1303’ through- aperture;

[0119] • a second portion of the second suture line length region 1242’ and a first portion of the third suture line length region 1243’ extends through the second inner pledget 1304’ through- aperture;

[0120] • a second portion of the third suture line length region 1243’ and a first portion of the fourth suture line length region 1244’ extends through the third inner pledget 1305’ through- aperture; and

[0121] • a second portion of the fourth suture line length region 1244’ and a first portion of the fifth suture line length region 1245’ extends through the fourth inner pledget 1306’ through- aperture.

[0122]

[0094] This embodiment allows the pledgets 130T to abut respective suture holes and to therefore counteract most or all of the stretching force applied to the suture holes when the suture portions are pulled apart, knotted, crimped or cut. The pledgets 130T also distribute the forces applied by the suture portions to respective suture holes over a wider surface area of the surrounding tissue. This may lessen the contact and tension between the tissue and the suture portions. Embodiments of the present invention, therefore, may reduce the risk of enlarging or pulling apart of the tissue when the suture portions are being pulled.

[0123]

[0095] In another embodiment, each of the inner pledgets 1303’, 1304’, 1305’, 1306’ and each of the outer pledgets 130T and 1302’ have only one through-aperture. Each through-aperture of the inner pledgets 1303’, 1304’, 1305’, 1306’ and the outer pledgets 130T, 1302’ is concentric with the first circular surface 1331 and the second circular surface 1332. In an embodiment, each through-aperture has a diameter of about 1 mm.

[0124]

[0096] In an embodiment, the single suture line 1200’ has an enlarged diameter or width in a region between the pledgets, in use. This aids in distributing load across the surrounding tissue.

[0125]

[0097] In another embodiment, each of the inner pledgets 1303’, 1304’, 1305’, and 1306’ comprises two through-apertures while each of the outer pledgets 130T and 1302’ only have one through-aperture. For each of the inner pledgets, the distance between a centre of a first through-aperture and a centre of a second through-aperture is between 0.5mm and 2mm, but preferably 1mm.. In this embodiment, a first portion of the first suture line length region 124T extends through the first outer pledget 130T through-aperture and a second portion of the fifth line length region 1245’ extends through the second outer pledget 1302’ through-aperture. Further in this embodiment:

[0126] • a second portion of the first suture line length region 124T extends through a first through-aperture of the first inner pledget 1303’ and a first portion of the second suture line length region 1242’ extends through a second through-aperture of first inner pledget 1303’;

[0127] • a second portion of the second suture line length region 1242’ extends through a first through-aperture of the second inner pledget 1304’ and a first portion of the third suture line length region 1243’ extends through a second-through aperture of the second inner pledget 1304’;

[0128] • a second portion of the third suture line length region 1243’ extends through a first through-aperture of the third inner pledget 1305’ and a first portion of the fourth suture line length region 1244’ extends through a second through-aperture of the third inner pledget 1305’; and

[0129] • a second portion of the fourth suture line length region 1244’ extends through a first through-aperture of the fourth inner pledget 1306’ and a first portion of the fifth suture line length region 1245’ extends through a second through-aperture of the fourth inner pledget 1306’.

[0130]

[0098] In other embodiments, the number of needles and corresponding suture line length regions 1240’ may be varied to more than or less than those shown in this embodiment.

[0131]

[0099] As shown in Fig. 11 , each pledget of the plurality of pledgets 1300 has a disc shaped body, the body having a first circular face 1331 and a second circular face 1332. Each pledge likewise has two through-apertures 1333, 1334 extending from at least a portion of the first circular face 1331 through to at least a portion of the second circular face 1332. Each through- aperture of the two through-apertures is adapted to receive one or more suture portions of the suture arrangement as provided in the abovementioned configuration.

[0132]

[0100] Each pledget of the plurality of pledgets 1300 has a diameter of 3 millimetres and a thickness of 1-2mm. The distance between a centre of one of the two through-apertures and a centre of the other one of the two through-apertures is about 1mm.

[0133]

[0101] A method of suturing using the single suture line arrangement 1000’ is provided as shown in Figs. 7 and 9. In a specific embodiment, the single suture line arrangement 1000’ is applied to an aortic annulus 2000’ and a sewing ring 3000’. It is to be appreciated that more or less inner needles 1130’ and needle securement regions 1210’, 1220’, 1230’ can be used depending on the size of the annulus and / or sewing ring. Each needle of the plurality of needles 1100’ is inserted through a corresponding portion of a first surface region 2010’ of the aortic annulus 2000’ to create corresponding suture holes, and extends outwardly from a second surface region 2020’ of the aortic annulus 2000. Preferably, the plurality of needles 1100’ are inserted at a consistent spacing along a circumference defined by the aortic annulus 2000’.

[0134]

[0102] Each of the plurality of needles 1100’ is then pulled through such that portions of corresponding suture line length regions 1240’ defined by the corresponding needle securement regions 1230’ are pulled through and respective pledgets of the plurality of pledgets 1300’ cover and cushion the corresponding suture holes. This arrangement counteracts most or all of the stretching force applied to the suture holes when the suture portions are pulled apart, knotted, crimped or cut. The pledgets 1300 also distribute the forces applied by the suture portions to respective suture holes over a wider surface area of the surrounding tissue. As further shown in Fig. 4, a suture organiser 4000’ may be provided to secure the needles separately from each other while an operation is ongoing. The suture organiser 4000’ holds adjacent suture line length regions that are connected to a common needle of the plurality of needles 1100’.

[0135]

[0103] When the first outer needle 1110’ is inserted through the first surface region of the annulus 2000’ creating a first hole, a portion of the first suture line length region 124T extends through that first hole. Correspondingly, a portion of the first suture line length region 124T and a portion of the second suture line length region 1242’ extends through a second hole of the annulus 2000’ created by the first inner needle 1131’, a portion of the second suture line length region 1242’ and a portion of the third suture line length region extends 1243’ through a third hole of the annulus 2000’ created by the second inner needle 1132’, a portion of the third suture line length region 1243’ and a portion of the fourth suture line length region 1244’ extends through a fourth hole of the annulus 2000’ created by the third inner needle 1133’, a portion of the fourth suture line length region 1244’ and a portion of the fifth suture line length region 1245’ extends through a fifth hole of the annulus 2000’ created by the fourth inner needle 1134’, and a portion of the fifth suture line length region 1245’ extends through a sixth hole of the annulus 2000’ created by the second outer needle 1120’.

[0136]

[0104] Each of the plurality of suture line length regions 1240’ is then pulled through such that the pledgets 1300’ are in contact with the first surface region 2010’ of the annulus 2000’.

[0137]

[0105] The plurality of needles 1100’ are then inserted through a first surface region 3010’ of the sewing ring 3000’ and then pulled outwardly from a second surface region 3020’ of the sewing ring 3000’. The sewing ring 3000’ is adapted to be connected to a prosthetic valve conduit 5000’. In other embodiments, the sewing ring 3000 can be connected to other organs, biological materials or other prosthetic materials or elements. After each needle of the plurality of needles 1100’ has been inserted through both the annulus 2000’ and the sewing ring 3000’, the sewing ring 3000’ is brought into contact with the annulus 2000’ by progressing the corresponding one of the plurality of suture line length regions 1240’ through the sewing ring 3000’.

[0138]

[0106] As shown in Fig. 8, the plurality of needles 1100’ are then removed from the single line suture 1200’. This is done by cutting a portion of each of the plurality of suture line length regions 1240’. In other embodiments, the needles may be removed from the single line suture 1200’ by other possible means. Each cut portion of the plurality of suture line length regions 1240’ defines a plurality of free suture ends 1400’. More specifically, the cut portions of the first suture line length region 124T define a first free suture end 140T and a second free suture end 1402’ respectively, the cut portions of the second suture line length region 1242’ define a third free suture end 1403’ and a fourth free suture end 1404’ respectively, the cut portions of the third suture line length region 1243’ define a fifth free suture end 1405’ and a six free suture end 1406’ respectively, the cut portions of the fourth suture line length region 1245’ define a seventh free suture end 1407’ and an eighth free suture end 1408’ respectively, and the cut portions of the fifth suture line length region 1245’ define a ninth free suture end 1409’ and a tenth free suture end 1410’ respectively. As stated previously, it is to be appreciated that the suture arrangement 1000’ shown in Figs. 7 and 8 may have more or less sutures 1200’ than provided for in this embodiment, which result in a corresponding more or less free suture ends 1400 after cutting.

[0139]

[0107] The free suture ends 1400’ that are defined by the cut portions of the same suture line length region are then knotted together. Specifically, the first free suture end 140T and the second free suture end 1402’ of the first suture line length region 124T are tied together, the third free suture end 1403’ and the fourth free suture end 1404’ of the second suture line length region 1242’ are tied together, the fifth free suture end 1405’ and the six free suture end 1406’ of the third suture line length region 1243’ are tied together, the seventh free suture end 1407’ and the eighth free suture end 1408’ of the fourth suture line length region 1245’ are tied together, and the ninth free suture end 1409’ and the tenth free suture end 1410’ of the fifth suture ling length region 1245’ are tied together.

[0140]

[0108] In other embodiments, the suture ends may be connected in any other suitable manner, such as by a crimping device or a thermal weld.

[0141]

[0109] In an embodiment, the colour of adjacent suture line length regions of the plurality of suture line length regions 1240’ alternates. Since the adjacent suture line length regions are differently coloured, it would be easier for the surgeon to determine which free ends belong to the same suture line length region. The surgeon would readily know that adjacent free suture ends of the plurality of free sutures ends 1400’ that are identically coloured belong to one suture line length region and are to be tied together.

[0142]

[0110] In an embodiment, the free suture ends that are adapted to be tied together are fixed together by a hand tied knot or a crimping device, such as a Cor Knot.

[0143]

[0111] This embodiment, in comparison to prior art, may almost have a 50% reduction in the number of needles required in typical applications and almost a complete reduction in the number of sutures required. The reduced number of needles is associated with various benefits.

[0144]

[0112] One benefit of the reduction in needle passes is that surgical time is significantly reduced. This, in turn, may reduce the trauma experienced by the patient and therefore can lead to better post-operative outcomes. Cardiopulmonary bypass time may likewise be reduced in the case that the operation requires this. There are likewise less needle passes.

[0145]

[0113] In other operations, where an organ transplant is required, such as a kidney transplant operation, reduced surgery time can reduce the risk of ischemic injuries and therefore improve post-operative outcomes.

[0146]

[0114] Another benefit of the suture arrangement 1000’ is that since the outer and inner needles are connected through the a single line suture, the risk of losing a needle or suture or associated device in a body, organ or other vital region is reduced.

[0147]

[0115] Figs. 12A-12B show another embodiment of the suture arrangement 1000” of the present invention. The suture arrangement 1000” comprises a plurality of needles 1100” and a plurality of suture portions 1200”. The plurality of needles 1100” include a first outer needle 1110”, a second outer needle 1120”, and a plurality of inner needles 1130”. The plurality of inner needles 1130” comprise a first inner needle 1131”, a second inner needle 1132”, a third inner needle 1133”, a fourth inner needle 1134”, a fifth inner needle 1135”, a sixth inner needle 1136”, a seventh inner needle 1137”, an eight inner needle 1138” and a ninth inner needle 1139”. The plurality of suture portions 1200” include a first suture portion 1201”, a second suture portion, 1202”, a third suture portion 1203”, a fourth suture portion 1204”, a fifth suture portion 1205”, a sixth suture portion 1206”, a seventh suture portion 1207”, an eight suture portion 1208”, a ninth suture portion 1209” and a tenth suture portion 1210”. Each of the plurality of suture portions 1200” comprises a first end region 1220” and a second end region 1230”.

[0148]

[0116] Each of the plurality of needles 1100” comprises a suture connecting end region 1140” configured to connect to at least a corresponding one of the plurality of suture portions 1200”. As shown in Figs. 12, the connecting end region 1140” of the first outer needle 1110” is connected to the first end region 1220” of the first suture portion 1201”. The connecting end region 1140” of the first inner needle 1131” is both connected to the second end region 1230” of the first suture portion 1201” and the first end region 1220” of the second suture portion 1202”. The connecting end region of the second inner needle 1132” is connected to both the second end region 1230” of the second suture portion 1202” and the first end region 1220” of the third suture portion 1203”. The connecting end region of the third inner needle 1133” is connected to both the second end region 1230” of the third suture portion 1203” and the first end region 1220” of the fourth suture portion 1204”. The connecting end region of the fourth inner needle 1134” is connected to both the second end region 1230” of the fourth suture portion 1204” and the first end region 1220” of the fifth suture portion 1205”. The connecting end region of the fifth inner needle 1135” is connected to both the second end region 1230” of the fifth suture portion 1205” and the first end region 1220” of the sixth suture portion 1206”. The connecting end region of the sixth inner needle 1136” is connected to both the second end region 1230” of the sixth suture portion 1206” and the first end region 1220” of the seventh suture portion 1207”. The connecting end region of the seventh inner needle 1137” is connected to both the second end region 1230” of the seventh suture portion 1207” and the first end region 1220” of the eighth suture portion 1208”. The connecting end region of the eighth inner needle 1138” is connected to both the second end region 1230” of the eighth suture portion 1209” and the first end region 1220” of the ninth suture portion 1209”. The connecting end region of the ninth inner needle 1139” is connected to both the second end region 1230” of the ninth suture portion 1209” and the first end region 1220” of the tenth suture portion 1210”. Finally, the connecting end region of the second outer needle 1120” is connected to the second end region 1230” of the tenth suture portion 1210”.

[0149]

[0117] In this arrangement, the first and second outer needles 1110” and 1120”, and the inner needles 1130” are connected in sequence through the common suture portions of the plurality of suture portions 1200”. This means that each of the inner needles 1130” connected to the respective suture portions, perform the function of passing two suture portions through the material, instead of one. In an application that required X number of suture portions, the present suture arrangement would only require X+1 number of needles.

[0150]

[0118] As shown in Figs. 12A-12B, the suture arrangement is provided with a plurality of pledgets 1300”. In the embodiment as shown, the plurality of pledgets 1300” comprises a first outer pledget 1301”, a second outer pledget 1302”, a first inner pledget 1303”, a second inner pledget 1304”, a third inner pledget 1305”, a fourth inner pledget 1306”, a fifth inner pledget 1307”, a sixth inner pledget 1308”, a seventh inner pledget 1309”, an eighth inner pledget 1310” and a ninth inner pledget 1311”. All the outer pledgets 1301”, 1302” and the inner pledgets 1303”-1311 ” comprise a disc shaped body having a first circular face and a second circular face. The outer pledget 1301” comprises a through-aperture extending from at least a portion of the first circular face through to at least a portion of the second circular face, wherein the through-aperture is adapted to allow a portion of the first suture portion 1201” to extend therethrough. The outer pledget 1302” comprises a through-aperture extending from at least a portion of the first circular face through to at least a portion of the second circular face, wherein the through-aperture is adapted to allow a portion of the tenth suture portion 1210” to extend therethrough.

[0151]

[0119] Each inner pledget 1303” to 1311” comprises a disc shaped body having a first circular face and a second circular face. Each inner pledget comprises one through-aperture extending from at least a portion of the first circular face through to at least a portion of the second circular face, through which respective suture portions extend. In this embodiment:

[0152] • a first suture portion second region and a second suture portion first region extend through a first inner pledget 1303” through-aperture;

[0153] • a second suture portion second region and a third suture portion first region extend through a second inner pledget 1304” through-aperture;

[0154] • a third suture portion second region and a fourth suture portion first region extend through a third inner pledget 1305” through-aperture;

[0155] • a fourth suture portion second region and a fifth suture portion first region extend through a fourth inner pledget 1306” through-aperture;

[0156] • a fifth suture portion second region and a sixth suture portion first region extend through a fifth inner pledget 1307” through-aperture;

[0157] • a sixth suture portion second region and a seventh suture portion first region extend through a sixth inner pledget 1308” through-aperture; • a seventh suture portion second region and an eighth suture portion first region extend through a seventh inner pledget 1309” through-aperture;

[0158] • an eighth suture portion second region and a ninth suture portion first region extend through an eighth inner pledget 1310” through-aperture; and

[0159] • a ninth suture portion second region and a tenth suture portion first region extend through a ninth inner pledget 1311” through-aperture.

[0160]

[0120] This embodiment allows the pledgets 1300” to abut respective suture holes and to therefore counteract most or all of the stretching force applied to the suture holes when the suture portions are pulled apart, knotted, crimped or cut. The pledgets 1300 also distribute the forces applied by the suture portions to respective suture holes over a wider surface area of the surrounding tissue. Embodiments of the present invention, therefore, may reduce the risk of enlarging or pulling apart of the tissue when the suture portions are being pulled.

[0161]

[0121] In an embodiment not shown, each suture portion of the plurality of suture portions 1200” has an enlarged diameter or width in a region between the pledgets, in use. This aids in distributing load across the surrounding tissue.

[0162]

[0122] Each pledget of the plurality of pledgets 1300” has a diameter of 3 millimetres and a thickness of 1-2mm.

[0163]

[0123] In an embodiment, each of the suture portions 1200” is the same length. The length of the suture portions and the material of the suture portions will be determined based on the type of surgery being performed.

[0164]

[0124] In other embodiments, the plurality of internal needles 1130” can be 1 , 2, 3 or any number of needles suitable for the particular surgery and the corresponding suture portions and pledgets 1300” may be varied accordingly.

[0165]

[0125] In this embodiment, each suture portion of the plurality of suture portions 1200” is coloured in one of two colours (in this case, blue and white), and the colour of adjacent suture portions of the plurality of suture portions 1200” alternates between the two colours. Therefore, in this embodiment the suture portions follow a “blue - white - blue - white” pattern. The alternation in colours may allow the user, for example a surgeon or their assistant, to distinguish which suture end region belongs to a specific suture portion and to distinguish the suture portions from one another.

[0166]

[0126] In the prior art, pledgets are located substantially in-between the suture holes such that in use (when the sutures are pulled apart, knotted, crimped or cut) the pledgets do not align with the suture holes produced. After a first needle is passed through a material (e.g. a tissue), the passing of a second needle through a material often causes the suture portions to twist, which, in turn, results in the pledget twisting under the material. This requires the surgeon to manually intervene to untwist the suture portions. In the present invention, as the pledgets are substantially or directly in-line with the suture portions, twisting is avoided.

[0167] Interpretation

[0168] Markush Groups

[0169]

[0127] In addition, where features or aspects of the invention are described in terms of Markush groups, those skilled in the art will recognise that the invention is also thereby described in terms of any individual member or subgroup of members of the Markush group.

[0170] Chronological sequence

[0171]

[0128] For this specification, where method steps are described in sequence, the sequence does not necessarily mean that the steps are to be carried out in chronological order in that sequence, unless there is no other logical manner of interpreting the sequence.

[0172] Embodiments

[0173]

[0129] Reference throughout this specification to “one embodiment” or “an embodiment” means that a particular feature, structure, or characteristic described in connection with the embodiment is included in at least one embodiment of the present invention. Thus, appearances of the phrases “in one embodiment” or “in an embodiment” in various places throughout this specification are not necessarily all referring to the same embodiment, but may. Furthermore, the particular features, structures, or characteristics may be combined in any suitable manner, as would be apparent to one of ordinary skill in the art from this disclosure, in one or more embodiments.

[0174]

[0130] Similarly, it should be appreciated that in the above description of example embodiments of the invention, various features of the invention are sometimes grouped together in a single embodiment, figure, or description thereof for the purpose of streamlining the disclosure and aiding in the understanding of one or more of the various inventive aspects. This method of disclosure, however, is not to be interpreted as reflecting an intention that the claimed invention requires more features than are expressly recited in each claim. Rather, as the following claims reflect, inventive aspects lie in less than all features of a single foregoing disclosed embodiment. Thus, the claims following the Description of Embodiments are hereby expressly incorporated into this Description of Embodiments, with each claim standing on its own as a separate embodiment of this invention.

[0131] Furthermore, while some embodiments described herein include some but not other features included in other embodiments, combinations of features of different embodiments are meant to be within the scope of the invention, and form different embodiments, as would be understood by those in the art. For example, in the following claims, any of the claimed embodiments can be used in any combination.

[0175] Different Instances of Objects

[0176]

[0132] As used herein, unless otherwise specified the use of the ordinal adjectives “first”, “second”, “third”, etc., to describe a common object, merely indicate that different instances of like objects are being referred to and are not intended to imply that the objects so described must be in a given sequence, either temporally, spatially, in ranking, or in any other manner.

[0177] Specific Details

[0178]

[0133] In the description provided herein, numerous specific details are set forth.lt is understood, however, that embodiments of the invention may be practiced without these specific details. In other instances, well-known methods, structures and techniques have not been shown in detail in order not to obscure an understanding of this description.

[0179] Terminology

[0180]

[0134] In describing the preferred embodiment of the invention illustrated in the drawings, specific terminology will be resorted to for the sake of clarity. The invention is, however, not intended to be limited to the specific terms so selected, and it is to be understood that each specific term includes all technical equivalents which operate in a similar manner to accomplish a similar technical purpose. Terms such as "forward", "rearward", "radially", "peripherally", "upwardly", "downwardly", and the like are used as words of convenience to provide reference points and are not to be construed as limiting terms.

[0181]

[0135] As used herein the term “and / or” means “and” or “or”, or both.

[0182]

[0136] As used herein “(s)” following a noun means the plural and / or singular forms of the noun.

[0183]

[0137] In this specification, the word material may refer to tissue, for example human or animal tissue, or to any other suitable inorganic or organic material. Comprising and Including

[0184]

[0138] In the claims which follow and in the preceding description of the invention, except where the context requires otherwise due to express language or necessary implication, the word “comprise” or variations such as “comprises” or “comprising” are used in an inclusive sense, i.e., to specify the presence of the stated features but not to preclude the presence or addition of further features in various embodiments of the invention.

[0185]

[0139] Any one of the terms: including or which includes or that includes as used herein is also an open term that also means including at least the elements / features that follow the term, but not excluding others. Thus, including is synonymous with and means comprising.

[0186] Scope of Invention

[0187]

[0140] Thus, while there has been described what are believed to be the preferred embodiments of the invention, those skilled in the art will recognize that other and further modifications may be made thereto without departing from the spirit of the invention, and it is intended to claim all such changes and modifications as fall within the scope of the invention. For example, any formulas given above are merely representative of procedures that may be used. Functionality may be added or deleted from the block diagrams and operations may be interchanged among functional blocks. Steps may be added or deleted to methods described within the scope of the present invention.

[0188]

[0141] Although the invention has been described with reference to specific examples, it will be appreciated by those skilled in the art that the invention may be embodied in many other forms.

[0189] Industrial Applicability

[0190]

[0142] It is apparent from the above, that the arrangements described are applicable to the medical and surgical industries.

Claims

Claims1. A suture arrangement comprising: a plurality of suture portions, each suture portion having two suture end regions; three or more needles comprising two outer needles and one or more inner needles, and each needle having a suture connecting end region; and three or more pledgets comprising two outer pledgets and one or more inner pledgets, each of two outer pledgets comprising a through-aperture and each of the one or more inner pledgets comprising one or more through-apertures; wherein:(i) each of the one or more inner needles has a suture connecting end region that is connected to one of the two suture end regions of each of two suture portions of the plurality of suture portions;(ii) each of the two outer needles has a suture connecting end region that is connected to one of the two suture end regions of one suture portion of the plurality of suture portions;(iii) each group of two adjacent needles of the three or more needles have suture connecting end regions that are connected by a common suture portion of the plurality of suture portions;(iv) each of the suture portions that connect to any one of the one or more inner needles extend through one of the one or more through-apertures of a respective one of the one or more inner pledgets; and(v) each suture portion that connects to an outer needle of the two outer needles extends through the through-aperture of the respective outer pledget of the two outer pledgets.

2. A suture arrangement as claimed in claim 1 , wherein each of the one or more inner pledgets comprises one through-aperture which receives both of the suture portions that are connected to one of the one or more inner needles.

3. A suture arrangement as claimed in claim 1 , wherein each of the one or more inner pledgets comprises two through-apertures and each aperture of the two through-apertures receives a single suture portion through it.

4. A suture arrangement as claimed in claim 1 , wherein each suture portion of the plurality of suture portions is coloured in one of two colours and the colour of adjacent suture portions alternates between the two colours.

5. A suture arrangement as claimed in claim 1 , wherein the plurality of suture portions are portions of a continuous, single suture.

6. A suture arrangement as claimed in claim 1 , wherein each pledget of the three or more pledgets comprises: a disc shaped body, the body having a first circular face and a second circular face; and one or more through-apertures extending from at least a portion of the first circular face through to at least a portion of the second circular face, wherein each through-aperture of the one or more through-apertures is adapted to receive one or more suture portions of the suture arrangement.

7. A suture arrangement as claimed in claim 6, wherein the pledget has a diameter of 3mm and a thickness of 1-2mm.

8. A suture arrangement as claimed in claim 6, wherein the one or more through-apertures is two through-apertures, and the distance between a centre of one of the two through-apertures and a centre of the other one of the two through-apertures is about 1mm.

9. A method of suturing using the suture arrangement of claim 1 , comprising the following steps: inserting the three or more needles through a first material and a second material; cutting the three or more needles away from the plurality of sutures portions to create a plurality of free suture portion ends; pairing the plurality of free suture portion ends such that each pair comprises one suture portion that was cut from a first needle of the three or more needles and the one suture portion that was cut from an adjacent needle of the three or more needles; and fixing the suture portions of each pair of sutures together.

10. A method of suturing as claimed in claim 8, wherein after the three or more needles are inserted through the first material and the second material, the second material is brought into contact with the first material by progressing a portion of the length of the suture portions through it.11 . A method of suturing as claimed in claim 8, wherein the first material is the annulus region of a heart valve and the second material is a sewing ring of a prosthetic heart valve.

12. A method of suturing as claimed in claim 8, wherein the free suture portion ends of each pair are fixed together by any one of the following fixing methods:(i) a hand tied knot; or(ii) a crimping device.

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