MXPA98005950A - Surgical implement particularly useful to implement cardia valve protesis - Google Patents

Abstract

A particularly useful surgical implement (10) for implanting a prosthetic valve (4) in an open annulus includes a hand grip (11), and a suture retainer (15) carried by the handle and having an outer face carrying a spiral spring (16) whose turns define an annular arrangement of cuts with surfaces of opposite openings to receive and detachably retain the sutures between selected turns. The optimal separation of the sutures according to the shape of the open annulus is obtained by providing reference ribs (17) between selected turns of the spring, and also by making the outer annular face of the suture retainer substantially the same as that of the open annulus. Implements are described, with and without suture retainer including an illuminating device (211) to artificially illuminate the work area. We also describe a method to implant a prosthetic valve in a fast and efficient way using those implemented

Description

SURGICAL IMPLEMENT PARTICULARLY USEFUL TO IMPLANT CARDIAC VALVE PROSTHESIS DESCRIPTION OF THE INVENTION The present application is a partial continuation of the U.S. patent application. or. 08/640, 149 filed on April 30, 1996. The present invention relates to a surgical implement particularly useful for implanting a prosthetic device in an open annulus. The invention is especially useful for implanting a cardiac valve prosthesis, and is therefore described further with respect to that application. The invention also relates to a new valve holder useful particularly with the above surgical implement. The invention also relates to a surgical method for implanting prostheses, particularly heart valves. Surgical replacement of a defective heart valve has become a widely practiced surgical procedure. In a surgical operation the defective valve is surgically removed and a biological or mechanical valve prosthesis is implanted in the open annulus by means of a plurality of sutures, generally varying from 12-20, depending on the size of the open annulus. That surgical operation includes cardiopulmonary bypass and cardiac arrest. The longer the period of cardiac arrest, the greater the risk of post-operative complications. Many implements have been proposed for use in those devices known from U.S. Pat. us. 4,185,636, 4,492,229, 4,932,965 and in my U.S. Pat. previous 4,702,250. However, as far as I know none of the previously known devices has found widespread use. An object of the present invention is to provide a new surgical implement particularly useful for implanting a prosthesis device, especially a cardiac valve prosthesis, which has advantages over previously known implements including that of my prior patent no. 4,702,250, as will be more particularly described below. Another object of the invention is to provide a valve holder with a new particular construction, but not exclusively, useful with the new prior surgical implement. Another object of the invention is to provide a new surgical method for implanting prostheses especially valves. In accordance with one aspect of the present invention a particularly useful surgical implement is provided for implanting a prosthesis in an annulus open by means of a plurality of sutures, comprising: a hand grip handle for manually supporting the implement during use; and a suture retainer carried by the handle constructed to releasably receive and retain a plurality of sutures; the suture retainer includes an outer annular face divided by divisions in a plurality of divisions, each division includes a space on the annular face between two adjacent divisions having retainers to releasably receive and retain the two opposite ends of at least one suture to be applied, The divisible can be visually discerned from the retainers to facilitate the application and uniform separation of the sutures. According to other features in the preferred embodiments described, each division includes at least two cuts for receiving and retaining releasable deformed opposite ends of the respective suture to facilitate identification and knotting of the opposite ends.

Preferably each division includes at least four cuts to allow the application of at least one additional suture in the respective division and the surgeon's opinion to also facilitate the application of sutures without aligning them within the respective division when the sutures are applied to the suture retainer. Each of the cuts has opposite converging surfaces to receive and retain releasably sutures of different thicknesses. According to other characteristics in the preferred embodiment described, the annular arrangement of the cuts is defined by means of a spiral spring held in an annular configuration around the outer annular face of the suture retainer for releasably receiving and retaining the sutures between selected turns of the spring, the spiral spring includes a plurality of turns in each of the divisions. While such a construction is particularly advantageous, other constructions, such as plastic discs having a grooved outer annular surface, or plastic lugs held in an annular shape and having a grooved outer surface, could also be used. According to another feature of the described preferred embodiments, the exterior face of the suture retainer includes a visually discernible representation of the general shape of the annulus open. This facilitates optimal separation of the sutures with respect to the open annulus. The preferred way of doing this is to make the outer annular face of the suture retainer generally have the same shape as that of the annulus open; preferably, however, it has a larger size to facilitate the handling of the sutures but it can also have a smaller size to minimize the obstruction of the surgical point. According to another aspect of the invention, a surgical implement is particularly useful for implanting a prosthesis in a work area, comprising; a manual grip handle; a support carried by the handle of a construction for releasably supporting the prosthesis; and an illuminator carried by the handle to project artificial light into the work area while the support holds the prosthesis; The illuminator includes a light conductor carried by the handle and having an end for receiving light from an external light source, the end of the light conduit passing through the support for driving light from the light front to the light area. job. The invention is particularly useful, and therefore is described below with respect to an implant in which the prosthesis is a prosthetic valve having a pivotal valve member in an open or closed position, and in which the support is a support for valve releasably holding the prosthetic valve with its valve member pivoted in the open position to allow light from the light conductor to pass through the valve holder and the protest valve is thus supported and illuminate the work area . According to another aspect of the invention, a valve holder is provided for holding a protest valve having a seam ring for implanting the valve in a work area, and a pivotal valve member, pivoting in the open and closed position; the valve holder includes a joining section for attaching the valve holder to a manipulable surgical implement and a releasable support section for releasably supporting the prosthetic valve; the valve holder is formed with a perforation extending through the valve. junction section and dimensioned to receive a light conduit from the surgical implement and to separate the tip of the light conductor from the pivotal valve member; the releasable support device supports the prosthetic valve with the valve member in its open position to allow light from the light conductor to pass through the valve holder and the prosthetic valve held there to illuminate the work area. Various embodiments of the invention are described with respect to different types of commercially available prosthetic valves with their respective valve supports. BRIEF DESCRIPTION OF THE DRAWINGS The invention is described here by way of example only, with reference to the accompanying drawings, in which: Figure 1 is a three-dimensional view illustrating one of the forms of surgical implement constructed in accordance with the present invention; Figure 2 is a top plan view illustrating the suture retainer in the implement of Figure 1; Figure 3 is a top plan view of another type of suture retainer that can be included in the surgical implement of Figure 1; Figure 4 is a partial sectional view illustrating a modification in the construction of the suture retainer of Figures 1 or 2; Figure 5 illustrates another embodiment of 1 invention including an artificial illuminator; Figure 6 illustrates another embodiment of the invention that shows another type of illuminator that can be used; Figure 7 illustrates another implement similar to that of Figure 6 including a valve holder for a known type of prosthetic valve; Figure 8 is a three-dimensional view of the valve holder of Figure 7; Figure 9 is a three-dimensional view of the valve holder of Figure 8 but seen from the bottom of the valve holder; Figures 10 and 11 are exploded side and top views, respectively, illustrating two pairs of the valve holder of Figures 8 and 9; Figure 12 illustrates an implement similar to that of Figure 7 but without the suture retainer; Figure 13 is an exploded view illustrating an implement similar to that of Figure 12 but with the valve holder for another known type of prosthetic valve; Figure 14 is a side view of the implement of Figure 13 in the assembled condition; Figure 15 is an exploded view illustrating another implement constructed in accordance with the present invention including a valve holder for another type of known prosthetic valve; Figure 16 illustrates only the valve holder of figure 15 seen from a different side; Figure 17 is a side view of the valve holder of Figure 16 in partial section and also illustrates the shape of its attachment to the implement; and Figure 18 is an exploded view illustrating the embodiment applied to another commercial valve holder for holding a commercial prosthetic valve. The surgical implements and those illustrated in the drawings are for implanting an aortic or pulmonary prosthetic valve that includes making an open annulus of a curved triangular shape. Thus, Fig. 1, illustrates in two the dead valve seat that has to be replaced in three the curved triangular open annulus prepared by the surgeon after removing the defective valve and preparing the seat to implant the prosthetic valve, and in four the valve to be implanted in the open place 3. Such a valve is normally provided with a seaming ring 5, for receiving the sutures 6, used when implanting the prosthetic valve in the open annulus 3. As will be more particularly described below, each suture 3, is a double arm suture, that is, it carries a needle at each of its two opposite ends to pass through the tissue in the open annulus 3, and through the seam ring 5, of the prosthetic valve 4. Each suture is also provided with a fold 8, for example of teflon, in order to increase the contact surface between the suture and the tissue that receives it in the open annulus. The surgical implement illustrated in Fig. 1, is designated by the numeral 10. It includes a grasrable handle 11, and a valve retainer 12, for detachably stopping the prosthetic valve 4. Any known type of retainer can be used for this purpose , for example, that described in my prior US patent 4,702,250. However, when the implement is to be used with illumination as described below, the valve retainer is preferably of the type described for the respective type of commercially available prosthetic valve. The surgical implement in Fig. 1 also includes a suture retainer, generally designated 15, carried by the handle 11, preferably in the distal portion of the handle near the prosthetic valve. A coil spring 16 is around the outer annular face of the retainer 15 for releasably receiving and retaining the sutures 16 between selected turns of the spring. For this purpose, the suture retainer 12 is integrally formed with a plurality of spaced ribs 17, having openings 18, (Fig. 2), for receiving the coil spring 16. The coil spring 16, as shown in Fig. 2, is made of wire of circular cross-section in a helix and supported in an annular configuration around the outer annular face of the suture retainer 15. The coil spring is applied with slight traction, so that being supported in the configuration illustrated, the turns are slightly pressed on the inner face 16a, of the spring, and tend to extend slightly on the outer face 16b. Thus, the helical spring forms an annular array of slots that have opposing yawning surfaces to receive and retain sutures in a removable manner. The cross section of the wire used for the springs results in the outer surfaces defining the grooves diverging in the outer direction, thus facilitating the insertion of the sutures between the turns. As described at the beginning, the outer shape of the retainer 15 is the same as the open annulus 3, prepared by the surgeon to implant the prosthetic valve 4, in the example illustrated in Figs. 1 and 2, the defective valve to be replaced is an aortic valve that includes opening an annulus 3, of a curved triangular configuration, therefore, the configuration of the retainer 15, of surgical suture also has the same triangular shape as the annulus open 3. The ribs or ribs 17, in addition to stopping the spring 16, in an annular configuration on the outer face of the retainer 15, also serve as visually distinguishable dividers that divide the outer annular face of the suture retainer into a plurality of divisions, one for each one of the sutures to be applied, for example, to the prosthetic valve illustrated in Fig. 1, fifteen sutures will normally be used, and therefore, there will be fifteen ribs 17, which divide the outer surface of the suture retainer into fifteen divisions, one to receive each of the fifteen sutures. Each of the fifteen divisions defined by the rib 17, at least and preferably accommodate three turns of the coil spring 16, defining at least two suture receiving slots, to facilitate, receive, identify and tie the two opposite ends of the suture that have to be received in the respective division. However, preferably there are more than three laps, for example, four, five laps in each division. This facilitates the application of sutures by the surgeon without requiring the surgeon to attempt to saturate at a precise location in the respective division of the suture retainer. This also gives the surgeon the option of adding an additional suture or two, anywhere in the open annulus that seems necessary during the course of the surgical operation. While the suture retainer 15 generally has the same external shape as the open annulus 3, it may be of a smaller size to facilitate handling and proper placement of the sutures in their respective locations. The suture retainer 15 can also be smaller in size or be made of transparent plastic to minimize the obstruction in the surgical seat. The surgical implement illustrated in Figs. 1 and 2, can be used in the following way to replace a defective aortic valve. The chest is opened by a central sternotomy and a cardiopulmonary passage is established by placing a cusp of the aortic root and the right atrium, the aorta closes and cardioplegia is caused in order to stop the heart. The aortic root is opened by an S-shaped incision, the defective aortic valve is opened and an open null 3 is prepared, of a curved triangular configuration to receive the prosthetic valve 4. The surgical implement 10, is preloaded with the prosthetic valve 4, but not with the suture 6, to be used in the implantation, rather, the implement is equipped with a suture retainer 15, of adequate configuration (in this case of a curved triangular configuration), corresponding to the open annulus 3 , to receive the prosthetic valve. Each of the sutures 6, carries a needle 7, on each of its two opposite ends, and a fold 8, in one place or slidable to the place of contact of the suture with the tissue around the open annulus. The stitch is started by passing the needle 7, at one end of the first suture 6, through the non-coronary cusp ring 20, and then through the seaming ring 5, of the prosthetic valve 4. That end of the suture is inserted then between a couple of turns of the spring 16, in the divisions given to that suture between the ribs 17, the suture remains with slight tension and is releasably retained under tension by the turns of the spring. The needle is then cut off from the respective end of the suture leaving an excess of suture at that end. The opposite end of the same suture is then applied in the same manner and inserted between a pair of turns adjacent to a first said receiving end in the same division defined by the ribs 17. The needle at that end is also cut off by removing it leaving an excess of suture on that end. The turns of the spring 16, removably retain both ends of the suture, so that the handle 11, can be pulled slightly outward to apply tension to the two ends of suture, and also to pull out slightly the tissue taken by the suture. The edge or fold 8 of the respective suture provides a large contact surface between the suture and the tissue, thus allowing this tension, but decreasing the possibility of breaking the tissue. If excessive tension is applied to the sutures, this will be compensated by the sliding of the sutures between the turns of the spring, taking to a minimum the risk of breaking the annulus tissue. The other sutures 6 are then applied in the same way, one after the other, according to the techniques of sailor, that is, from the outside to the inside. They are received between adjacent turns of the spring 16, in their respective divisions defined by the ribs 17, of the suture retainer 15, according to their respective positions in the open annulus. After all the sutures have been applied and their needles removed, the handle 11 can move slightly outward to tighten all the sutures and expose the open annulus better. If it is found that a suture does not have enough tension, this can be corrected by pulling on the respective suture to apply the appropriate tension. As mentioned above, if excessive tension is applied to one or more of the sutures, the respective sutures will simply slip between the spring turns, thus reducing the risk of tearing the annulus tissue. After the sutures have been applied to the open annulus and subjected to tension to better expose the annulus, the prosthetic valve 4 is released from the retainer 12, in the manner described below, and slides into place within the annulus. Each pair of sutures are now tied and cut, then the aortic opening is sutured and the aortic staple is released to allow the heart to resume the beats, the use of the surgical implement illustrated in Figs. 1 and 2, allows to obtain several important advantages in comparison to the existing techniques: thus, the novel implement allows the surgeon to select the type of suture that he will use, something that was not allowed with the pre-loaded suture retainers. It also allows the simultaneous suture of the open annulus and the seam ring of the valve even when double-arm sutures are used in the marine form, which is by far the most popular technique that is used at present, but with a minimum of lost time by the needle search. This allows the cardiac arrest time to be significantly reduced compared to the present techniques.

The implement and procedure described above also provide less exposure and division of the stitch for the surgeon. It also allows adjustments in the length of the suture, reduces the danger of ring tears, retains sutures without binding or knotting, and decreases the possibility of entanglement or having loose ends in the suture when applied. Furthermore, forming the annular surface of the suture retainer generally with the same configuration of the open annulus, and dividing this annular surface into divisions according to the sutures to be applied, greatly facilitates the application of each suture in its proper place without the surgeon has to direct precisely each suture.

In addition, providing each division with at least two cuts helps the application, identification and knotting of the opposite ends of each suture; providing more than two cuts in each division allows the surgeon to add a suture at any point if this appears to be necessary or desirable during the course of the operation. All the above advantages are extremely important to reduce post-operative mortality and obility and particularly the danger of frequently fatal post-operative paravulvular leaks. Figure 3 illustrates a suture retainer for use in implanting the prosthetic valve that requires an open annulus with a curved oval shape, such as when a mitral valve or a tricuspid valve is implanted. In this case, the suture retainer, designated 115, will have the same oval shape as the open annulus to be prepared for the respective valve. It could be slightly larger in size to facilitate suture management, or slightly smaller in size and preferably transparent to reduce obstruction of the surgical site. In all other respects, the suture retainer illustrated in Figure 3 would be incorporated into the surgical implement illustrated in figure 1 and would be used in the same way as that described above to implant the prosthetic valve. In the suture retainer 115 illustrated in Figure 3 (as well as the one illustrated in Figures 1 and 2), the coil spring 116 is retained in an annular configuration around the outer face of the suture retainer which is passed through. the holes 118 in the ribs 117 formed integrally in the suture retainer. Figure 4 illustrates a variation in which the ribs, designed with 127, are provided with edge grooves 128 to retain the coil spring in its annular configuration around the outer face of the suture retainer. Thus the spiral spring can be formed in an endless circuit and simply applied by means of the edge slot 128 in the ribs 127. The use of annular spiral spring applied around an annular suture retainer formed with the ribs as described above is has found that it is particularly advantageous since that construction defines an annular array of cuts having reference marks for the suture to receive and retain the sutures releasably. However, other suture retainer constructions having such characteristics could be used, such as a plastic disc or an annular tube or bar formed with a plurality of radially extending cuts advancing inward from its outer edge. Also, although it is preferred to form the suture retainer with an outer annular face generally in the same manner as that of the open annulus in order to facilitate optimal separation of the sutures with respect to the open annulus, other arrangements could be used to provide a representation visually discernable form of the open annulus. For example, the shape of the open annulus could be obtained from the suture retainer, which may therefore have another shape (eg circular shape) to facilitate optimal separations of the sutures with respect to the open annulus. Also visually discernible divisions of the outer annular surface of the suture retainer could simply have the form of markings applied to the suture retainer, and not the ribs formed integrally with the suture retainer - Figures 5 and 6 illustrate implements similar to those of Figure 1, but including an artificial illuminator to illuminate the work area. To facilitate understanding, the same reference numbers have been used in these figures as in Figure 1 to identify the corresponding elements. In the implement of Figure 5, the suture retainer 15 is provided with three light sources 201, 202, 203 (e.g.

LEDs), energized by batteries 204 within a battery compartment 205 in handle 11, to illuminate the work area in the lower portion of the suture retainer. In figure 6 the artificial illuminator includes a light conductor in the form of a bundle of optical fibers 211 inside the handle 11 optically engageable at one end of a lantern (not shown), such as that provided for the pediatric bronchoscopy commonly existing in the operating rooms, and extending to the valve support 12 so that the prosthetic valve 4 illuminates the work area. Figure 7 illustrates an implement similar to that of Figure 6 equipped with an artificial illuminator that includes a light conductor in the form of an optical fiber 211 extending through the handle 11. Figure 7 also illustrates a particular construction of the support of valve 12, as described below with reference to figures 8-10. An end section 220 of the handle between the handle 11 and the valve holder 12, is formed with an outer cord 220a for threadably receiving the valve holder 12.

The optical fiber 211 serves as the light conductor to conduct the light to illuminate the work area, passes through the perforations in the handle 11, if extreme section 220, and the valve holder 12 supported by this last section. The end of the optical fiber 211 terminates within the valve holder 12 but is spaced above the prosthetic valve 4 supported by the support so as not to interfere with the prosthetic valve members 4, as more particularly described below with reference to the Figures 8-11. In order to accurately locate the tip 21la of the optical fiber 211 with respect to the valve holder 12, an annular collar 222 is fixed to the optical fiber 211 to be engageable with the outer end of the handle 11 and thus limit the position of the tip 211a of the optical fiber with respect to the valve holder 12. Figures 8-11 illustrate a novel construction of the valve holder 12 that can be used with the implement of Figure 7 as well as the other implements described herein. The valve holder 12 illustrated in Figures 8-11 is similar to a known construction, for example as described in U.S. Pat. 5,443,502 but includes a number of modifications to allow the valve holder to be used with respect to a well-known type of prosthetic valve and to give rise to the light conduit of the illuminator to illuminate the work area.

As shown particularly in FIGS. 10 and 11, the valve holder 12 is constituted by two pivotal parts 201, 302 each formed at its lower end with an arm 303, 305. The part 301 further includes at its upper end, a collar 306 formed with an inner cord cap 207 for screwing the outer cord end 220a (FIG. 7) of the intermediate handle section 220. The cylindrical collar 306 at one end of the pivotal portion 301 is attached to an arm 303 by means of an intermediate section 308 of the semi-cylindrical configuration and formed on its opposite sides with a pair of aligned cylindrical perforations 309 communicating with the outer surface of the section by means of a pair of slots 310. The pivotal part 302 includes a section 311 on one end, with a similar semi-cylindrical configuration that would complement the intermediate section 308 of the pivotal part 301. The pivotal part 302 also includes a pair of cylindrical stumps 312 integrally formed with the intermediate section 311. These trunnions can be received by means of the slots 310 in the cylindrical perforations 309 of the intermediate section 308 of the pivotal 301. The arrangement is such that when the trunnions 312 are received within the perforations 309, the pair of arms 303, 305 are mounted pivotally together at their upper ends to assume either an operative position, as shown in Figures 8 and 9, to hold the prosthetic valve 4, or to a collapsed position to release the prosthetic valve. The prosthetic valve 4 may have a conventional construction including a seaming ring as previously described and a pair of pivot wheel valve members 321, 322. When the prosthetic valve 4 is applied to the valve support, the pivot arms 303, 305 of the valve holder are received within the leaflets 321, 322 to pivot the two leaflets in their open positions, to allow the light of the optical fiber 211 to pass through the valve and illuminate the work area. In the mitral position, the two leaflets 321 322 tend to open by gravity. However, in the aortic position, the two leaflets tend to close by gravity. To ensure that the two pivot arms 303, 305 pivot the leaflets 321, 322 of the prosthetic valve in their open positions in the aortic position, the lower faces of the two arms 303, 305 are integrally formed with bevelled curved ribs 323, 324 ( figure 9) engageable with the leaflets to move them pivotally to their open positions. A cord 325 received within a circumferential recess 326 in part 201 and a corresponding access 327 in the portion 302, retains the two parts in their support positions holding the prosthetic valve 4. When the prosthetic valve must be released from the valve holder, the rope 325 is cut allowing the two arms 303, 305 to collapse to a release position releasing the prosthetic valve. The curved bevelled ribs 323, 324 formed on the inner side of the two arms 303, 305, also assist the prosthetic valve 4 to fall by gravity when the two arms pivot to their release positions when cutting the rope 325. To facilitate the cutting of the rope 325, the pivotal part 301 is also formed with an axial groove 331 (figure 8) intersecting the groove 326 receiving the rope 325. In addition the part 302 is also formed with an axial groove 332 aligned with the axial groove 331 The slot 327 in the part 302 does not extend completely around the outer surface of that part, but rather is formed on the inner surface of that part for a portion of its length as shown in the dotted line section 327 'in Figure 8. The slot 326 in the pivotal part 301 also includes a corresponding section (not shown) formed on the inner surface of that part, or not on the outer surface. The rope 325 in turn is formed with two knotted ends 325a, 325b extending through the openings emerging from the inner slot section 327 'and the corresponding section of the slot 326. Thus, when the rope 323 is cut off , the rope will be positively retained within the valve holder and not allowed to fall into the open annulus. The implement illustrated in Figure 7 is used with the optical fiber 211 to illuminate the work site, and with the valve support 12 to hold the protest valve to be implanted, as follows: The collar 222 is fixed to the optical fiber 211 in the place such that when the optical fiber is passed through the perforations aligned in the handle 11, in the final section 220, and the valve holder 12, the outer tip 211a of the optical fiber will only penetrate the inside of the valve holder but it will be separated above the prosthetic valve 4 supported by the support. The valve holder 12 is conveniently attachable to the implement by screwing the lower end 220a of the handle section 220 into the socket 307 of the valve holder. The valve holder 12 would be applied to the implement with the prosthetic valve 4 attached to it, with the arms 303, 305 of the valve holder in their operative positions holding the prosthetic valve. The arms 303, 305 are retained in their operative position by the thread 325 enclosing in a circle the upper ends of the two pivotal parts 301, 302, When the prosthetic valve 4 is attached to the valve holder, the two arms 303, 305 to ensure that the two prosthetic pivotal valve leaflets 321, 322 pivot to their open position, such that those leaflets do not interfere with the prosthetic valve. the passage of light from the optical fiber 211 to the working point. After the sutures are thus applied to the prosthetic valve as described above, the rope 325 is cut off, allowing the two arms 303, 305 of the valve holder to collapse which releases the valve. As described above the two buttons 325a, 325b formed in the cord, as well as the internal point of the recess section 327 '(and the corresponding section of the recess 326) that receives the cord, ensure that the cord when cut, will be retained inside the valve holder and will not fall into the open annulus. The valve holder can be made of any suitable transparent, translucent or opaque material.

Preferably, however, its outer surface is rough to avoid reflection of light towards the eyes of the surgeon. The implement illustrated in Figures 7-11 can be used to illuminate the intracardiac cavities, such as the right or left atrium, the right or left ventricle, the aortic root, etc., with very intense illumination from a very short distance, avoiding interference with light, shadows, etc. Since the lighting is conducted by means of a light conductor (for example a bale of optical fibers of approximately 3 mm in diameter), a minimum of heat is produced at the work site, which is a very important advantage during the heart surgery. In addition, the prosthetic valve leaflets effectively reflect and distribute the light to the work area. The illuminator also produces better vision and less exposure in deep cavities that are difficult to illuminate. Figure 12 illustrates an implement similar to that described above with respect to Figures 7-11 but without the suture retainer 15. Such an implement therefore can provide all the advantages described above for illuminating the work site, but can use other arrangements to apply the sutures. Another feature of the implement illustrated in Figure 12 is that its end section 220 of the handle 11, which engages the handle to the valve holder 12, includes a flexible portion, shown at 350. The portion 350 flexes laterally from the axis of the handle and retained in its flexed position to facilitate manipulation of the valve holder, and the prosthetic valve thus retained with respect to the work area. That flexible portion 350 could for example be a spiral or strip of plastic, metal or metal coated with plastic, which can flex laterally and which has memory to retain its flexed configuration until it flexes to another configuration. As shown in Figure 12, such construction is particularly advantageous when the implement does not include a suture retainer, since flexing the implement as described above would interfere with the sutures retained by the retainer.

Figures 13 and 14 illustrate an implement 60, and a valve holder 370, for releasably supporting another known type of prosthetic valves 380. The implement 360 includes a light conductor 361 extending through the implement handle to engage to an external light source (not shown) and a square head 362 joined by a snap fit within a bushing in a collar 371 carried by the valve holder 370. The implement 360 further includes a flexible portion 363 corresponding to the flexing portion 350 in the element of Figure 12. When the valve holder 370 is attached to the implement 360, the tip of the light conduit 361 is received within a bore 372 formed in the valve holder to conduct light from the light conduit 361 to the work area by means of the openings in the valve holder 370 and the prosthetic valve 380 releasably held therein. The valve holder 370 includes a pair of hooks 373, 374 that are pivotably mounted to releasably hold the pro-static valve 380. Those hooks are normally retained in their support positions by means of a rope 375 (FIG. 14), which is short to release the prosthetic valve 380. The prosthetic valve 380 is a commercial type that includes a seaming ring 381 and a pair of pivot-wheel type valve members 382, 383. The valve holder 370 is also of a commercial type known normally retained in its support positions by means of a thread 375 (FIG. 14) that is cut to release the prosthetic valve 380. The prosthetic valve 380 is of a commercial type that includes a seaming ring 381 and a pair of prosthetic members. valve in the form of a pivotal handwheel 382, 383. The valve holder 370 is also of a commercially known type usually provided with a prosthetic valve 380, except that in this case its collar 371, constituting its joint section for attachment to the attachment 360, is formed with a perforation 372 sized to receive the tip of the light conductor 361. In this known type of prosthetic valve, the two leaflets 382, 383 are normally pushed to their open pivotal positions when held by the valve holder, allowing light from the light conductor 3360 to pass through the valve holder and the valve to the workplace. Since the valve holder 370 and the prosthetic valve 380 have a commercial design, details of their construction are not described. Figures 15-17 illustrate the invention made in another known type of prosthetic valve, generally designated 400, normally provided with another known type of valve holder, generally designated 500. Thus the prosthetic valve 4040 includes a titanium body 401, a seaming ring 402, and a single disc valve member 403 pivotally at its center relative to a guide member 404 carried by a transversely extending bar 405. The valve holder 500 includes a body 501 and a section of union with internal rope 502 to join the external threaded end of the 5023 implement handle (figure 17). The body 501 of the valve holder is provided with a pair of axially extending bevelled teeth or forks 504, 504 separated by a space 506 to give rise to the transverse bar 405 of the prosthetic valve. Thus when the prosthetic valve 400 is supported by the valve holder 500, the two forks 504, 505 are received within the body 401 by seating the crossbar 405, the transverse bar being accommodated by the space 506 between the two forks. A rib 507 (Figure 16) on the opposite side of the body of the support 501 engages the opposite side of the valve body 401. The valve is retained within the support 500 by means of a rope 508 extending through the openings 509, 510 on the support, the rope is cut by the surgeon to release the valve from the support. Since both the prosthetic valve 400 and the valve holder 500 have known constructions, other details of their construction and operation are not described here. For example, the prosthetic heart valve 400 may be the "Hall" prosthetic heart valve (registered trademark) distributed by Medtronic, Minneapolis, Minnesota, and the valve holder 500 may be the support provided with the valve. In this case, however, the valve holder 500 is modified to result in the light conductor 511 carried by the implement handle 503 and received inside the collar 502 when the valve holder is attached to the implement handle, and also by providing two hairpins or teeth 504, 505 with perforations or passages therethrough 504a, 505a, for driving light from the light conductor 511 through the prosthetic valve to the work site. When the valve is supported by the support, the two beveled forks 504, 505 retain the valve member 403 in its open position, ensuring the passage of light directly to the work site. Figure 18 illustrates another form of the valve holder that is currently marketed, similar to the valve holder of Figures 8 '11 to support a prosthetic two-leaf valve, Thus the implement illustrated in Figure 18 includes a handle 600 which is usually solid. In this case, however, it is formed with a longitudinally extending perforation 601 to receive the light conductor 602 to transmit the light by means of the valve support and the valve thus held, to the work area. The implement illustrated in Figure 18 on the other hand has a commercial construction, including a pair of trunnions 603, 604 received pivotally within the bushing 605,606 formed in a pair of pivotal arms 607, 608 whose arms are normally retained in the support position by means of a rope (not shown) and collapsing to the release position when cutting the rope in the same manner as the valve holder illustrated in Figures 8-11. Other variations can be made to the invention.

For example, another valve holder similar to that of Figures 15-17 exists commercially, including four beveled forks, and not two. It has been found that illuminating the arrangement of the present invention is illustrated in Figures 15-17 can also be used in the construction of the valve holder with two of the bevelled forks formed with the perforations for passage of light. Another possible arrangement is to make the light conductor penetrate the valve support from one side and not along its central axis. This can be particularly advantageous in tissue valves to prevent penetration through the cusps, and the extension of the optical fiber to one or more sides of the support can be implemented. Many other arrangements will be apparent to those skilled in the art. Although the invention has been described with respect to several preferred embodiments it will be apparent that these are only presented to exemplify, and that many features without other features could be used. For example, the suture retainer could be used with or without the illuminator, and vice versa. In addition, the invention could be used with a fiber optic focus of the two-channel type, in which one channel is used to illuminate the work area, and the second channel is used to take images of the work area for presentation purposes or recording. Also although the invention is particularly useful for implanting prosthetic valves, it will be appreciated that other prosthetic devices could be implanted in an annulus open in the manner and with the implement described above. Many other variations, modifications and applications of the invention will be apparent.

Claims (5)

1. CLAIMS 1. A surgical implement particularly useful for implanting a prosthetic device in an open annulus through a plurality of sutures, comprising: a manually grasped handle to manually support the implement during use; and a suture retainer carried by the handle constructed to releasably receive and retain a plurality of sutures; the suture retainer includes an outer annular face divided by dividers in a plurality of divisions, each division including a space on the annular face between two adjacent dividers having retainers to releasably receive and retain two opposite ends of at least one suture that to be applied, the dividers are visually distinguishable from the retainers to facilitate the application and uniform distance of the sutures.
2. 2. The implement according to claim 1, wherein each of the divisions includes at least two slots for releasably receiving and retaining the opposite ends of the respective suture to facilitate identification and binding of the opposite ends.
3. 3. The implement according to claim 2, wherein each of the divisions includes at least four slots to allow the optional application of at least one additional suture in the respective division, as well as facilitating the application of sutures without precisely treating it. within the respective division when applying the sutures to the suture retainer.
4. 4. The implement according to claim 2, wherein the annular groove arrangement is defined by a helical spring supported in an annular configuration around the outer annular face of the suture retainer to receive and retain in a removable manner the sutures between Selected turns of the spring, the helical spring includes a plurality of turns in each of the divisions.
5. 5. The implement according to claim 1, wherein the annulus is to be opened in a predetermined non-circular manner according to the shape of the prosthetic device to be implanted, and wherein the suture retainer includes a visually discernible representation. of the general form of the annulus to facilitate an optimal distancing of the sutures with respect to the annulus. 6. - The implement according to claim 1, which also includes a lighting device to project artificial light in the work area of the annulus. 7. - An implement according to the claim 1, wherein the manually grasped handle is on a suture retainer side, and wherein the implement carries on the opposite side of the suture retainer a valve holder adjacent to the suture retainer to detachably arrest a prosthetic valve that has to implant in the open annulus. 8. A surgical implement particularly useful for implanting a prosthetic device in an annulus to be opened in a predetermined non-circular manner according to the shape of the prosthetic device to be implanted, the implement comprises: a manually grasped handle; a suture retainer carried by the handle; the suture retainer includes a visually discernible representation of the general non-circular shape of the annulus to facilitate optimal distance of the sutures with respect to the annulus. . - The implement according to claim 8, wherein the external annular face of the suture retainer has in general the same shape as that of the annulus. 10. - A surgical implement particularly useful to perform a surgical operation that includes the application of sutures in a work area, the implement comprises; a handle that can be grasped manually; a suture retainer carried by the handle, constructed to releasably retain at least one suture; and a lighting device carried by the implement to project artificial light into the work area while the suture retainer retains at least one suture. 11. - The implement according to claim 10, wherein the lighting device includes a light conduit in the handle to conduct light from a light source to the working area of an open annulus. 12. The implement according to claim 11, wherein the handle also carries a valve holder to hold a prosthetic valve, and wherein the light conductor penetrates the suture retainer and the valve holder. 13. The implement according to claim 10, wherein the suture retainer is constructed to detachably hold a plurality of sutures. 14. A surgical implement particularly useful for implanting a prostatic device in an open annulus of a work area by means of a plurality of sutures, comprising: a manually graspable handle; a holder for the prosthetic device to be implanted in the annulus; and a lighting device carried by the implement to project artificial light into the working area of the annulus while the holder supports the prosthetic device. 15. The implement according to claim 14, wherein the implement further comprises a suture retainer carried by the handle to detachably hold a plurality of sutures. 16. A surgical implement particularly useful for implanting a prosthetic device in a work area, which comprises: a manually graspable handle; a retainer carried by the handle of a construction for releasably supporting a prosthetic device; and an illuminator carried by the handle to project artificial light into the work area while the holder holds the prosthetic device; the illuminator includes a light conductor carried by the handle and having one end to receive light from an external light source, the opposite end of the light conductor stops through the holder to conduct light from the light source to the work area . 17. - The implement according to claim 16, wherein the light conductor passes through aligned holes in the handle and the valve holder, and includes an annular collar fixed to the light conductor and engageable with the handle to limit the position of the external tip of the light conductor with respect to the valve holder or retainer. 18. A valve holder for stopping a prostatic valve having a seam ring for implanting the valve in a work area, and a pivotal valve member for opening and closing positions. the valve retainer includes a joining section for attaching the valve holder to an operable surgical implement, and a releasable retaining section for releasably stopping the prosthetic valve; the valve retainer is formed with a bore extending through the junction section and sized to receive a light conductor from the surgical implement and to distance the tip of the light conductor from the pivotal valve member; the detachable holding device stops the prosthetic valve with the valve member in its open position to allow light from the light conduit to pass through the valve retainer and the prosthetic valve stopped, so as to illuminate the work area.