US20050027352A1 - Annuloplasty ring delivery system and method - Google Patents

Abstract

An assembly for holding a substantially flexible suture guide of predetermined length in a substantially taut position used to achieve a suture line having a dimension equal to the length of the suture guide, such as the circumference about a heart valve annulus. The assembly includes a rigid suture guide holder having a surface against which the length of suture guide is releasably positioned. The guide holder can have a shape or geometry, such as a circumference or circumferential segment, equivalent to the shape or geometry of the intended suture line. The shape of the guide holder can therefore be selected to hold the suture guide in the shape most advantageous to placing the desired suture line. The assembly further includes a mechanism for releasably binding the suture guide to the surface of the holder and a detachable handle extendibly attached to the holder by means of a lanyard so that the handle can be detached to afford an unobstructed view of the surgical site, but cannot be removed from the surgical site until the holder has also been removed.

Description

RELATED APPLICATIONS
• This application is a continuation-in-part of co-pending U.S. patent application Ser. No. 387,909, filed on Jul. 31, 1989 and Ser. No. 444,189 filed on Nov. 30, 1989. The present invention relates to a surgical suture guide used to control the dimension and/or shape of a suture line placed during surgical repair of an organ or body part. In particular, the present invention relates to a combination of a flexible suture guide releasably attached to a rigid holder for controlling the spacing and placement of surgical sutures.
BACKGROUND OF THE INVENTION
• During surgical repair of an organ or other body part, the surgeon typically makes an incision to open the organ. Upon closure of the surgical wound, sutures are placed in the various layers of tissue to draw the two edges of the wound together so that the healing process can reform a smooth and competent surface. However, sutures often tear through the tissue if they are subjected to stress, thus damaging the surgical closure of the wound. It would be desirable in many instances to have a means for lending permanent support to strengthen and support the wall of the organ into which the surgical incision has been placed. Alternatively, in many instances it would be preferred to have a biodegradable suture guide.
• In many cases, the incision is not a straight line, but is shaped to conform to an anatomical requirement, making it difficult for the surgeon to balance the tension on the sutures to form the desired shape. In a number of instances the suture line is substantially curvilinear and it is of utmost importance that the suture line maintain a predetermined dimension. For example, when two blood vessels, or other vessels, such as intestines, are sutured together, the need exists for some means of preventing the suture line from constricting the vessel so as to create a potential point of blockage. Similar problems arise during bowel and bronchial resection. As another example, when the surgeon is reducing the size of a stomach by surgical means, the need exists for a means to assure that the reshaped organ will have a particular circumferential dimension and that the pleats used to reduce the size of the organ are evenly distributed so as to avoid formation of areas of reduced flexibility along the suture line. In other situations, such as in cosmetic surgery, the surgeon may desire to assure that the suture line is limited to a predetermined length.
• In all of these situations, it is desirable to use a suture guide to aid the surgeon in achieving the desired dimension of the surgical closure and/or to rigidly support the area where the sutures are placed, thus avoiding the danger that the sutures will tear through the tissue or that the suture line will act like a draw string and undesirably bunch up the tissue.
• These problems are particularly acute in the surgical procedure known as annuloplasty wherein any of a number of types of prostheses have been used in surgical correction of deformed nitral or bicuspid heart valves.
• Diseases and certain natural defects to heart valves can impair the functioning of the cusps of the valves in preventing regurgitation of blood from the ventricle into the atrium when the ventricle contracts. For example, rheumatic fever and bacterial inflammations of the heart tissue can distort or dilate the valvular annulus, thus resulting in displacement of the cusps away from the center of the valve and causing leakage of blood during ventricle contraction.
• Two techniques, generally known as annuloplasty, are used to reshape the distended and/or deformed valve annulus. In the technique known as “plication,” the circumference of the valve annulus is reduced by implanting a rigid or semi-rigid prosthetic ring of reduced circumference about the base of the annulus while the annulus is pleated to reduce its circumference to that of the ring. In the technique known as “reconstruction”, the circumference of the annulus is not reduced, but the annulus is restructured into an elongate shape. To accomplish this goal, a rigid or semi-rigid ring having the same circumference as the annulus but in an elongate or elliptical shape is surgically implanted about the base of the valve. Both plication and restructuring are intended to eliminate the gap in the closure of the distended valve by bringing back together the tips of the valve cusps.
• Many different types of prostheses have been developed for use in annuloplasty surgery. In general, prostheses are annular or partially annular shaped members that fit about the base of the valve annulus initially the prostheses were designed as rigid frame members, or “rings”, of metallic or other rigid materials that flex little, if at all, during the normal opening and closing of the valve. Since a normal heart valve annulus continuously flexes during the cardiac cycle, a rigid ring prosthesis interferes with this movement and thereby restricts movement of the valve itself. Sutures used to implant rigid ring prostheses consequently undergo stresses sufficient to tear the sutures loose. Examples of rigid annuloplasty ring prostheses are disclosed in U.S. Pat. No. 3,656,185, issued to Carpentier on Apr. 18, 1972; and U.S. Pat. No. 4,164,046, issued to Cooley on Aug. 14, 1979. Others have suggested the use of completely flexible annuloplasty ring prostheses. Examples of completely flexible ring prostheses are disclosed in U.S. Pat. No. 4,290,151, issued to Massana on Sep. 22, 1981, and are discussed in the articles of Carlos D. Duran and Jose Luis M. Ubago, “Clinical and Hemodymanic Performance of a Totally Flexible Prosthetic Ring for Atrioventricular Valve Reconstruction”, 5Annals of Thoracic Surgery, (No. 5), 458-463, (November 1976) and M. Puig Hassana et al, “Conservative Surgery of the Mitral Valve Annuloplasty on a New Adjustable Ring”,Cardiovascular Surgery1980, 30-37, (1981).
• Flexible prostheses generally include an inner support member formed from a flexible material. This-support member is wrapped in woven, biocompatible cloth material. Realignment of valve cusps during opening and closing of the valve is obtained by the proper suturing of the ring about the valve annulus. However, completely flexible ring prostheses provide almost no support to the suture area during the precarious implant procedure. Even though the surgeon attempts to evenly distribute the sutures along the periphery of the valvular annulus, during implant the draw-string effect of the sutures tends to bunch the material covering the flexible ring so that the sutures also bunch together at localized areas around the ring. This phenomenon, known as multiple plications in the heart valve annulus, causes rigid areas around the annulus. Thus, the flexible ring actually ends by imparting areas of rigidity and thereby distorts the valve annulus during the opening and closing of the valve despite the desired reduction in circumference of the valvular annulus.
• To overcome some of the drawbacks of rigid ring prostheses, still further types of annuloplasty prostheses have been designed to allow for adjustment of the ring circumference, either by the surgeon during implant, or automatically as the implanted ring moves during the opening and closing of the valve. This type of adjustable prosthesis is typically designed in combination with a rigid, or at least partially rigid, frame.
• An example of a self adjusting ring prosthesis is taught in U.S. Pat. No. 4,489,446, issued to Reed on Dec. 25, 1984. To provide for self adjustment of the prosthetic annulus, two reciprocating rigid netal pieces form the frame. U.S. Pat. No. 4,602,911, issued to Ahmadi et al. and U.S. Pat. No. 4,042,979, issued to Angell on Aug. 23, 1977, provide further adjustable ring protheses having a mechanism for adjusting the circumference of the ring. But due to rigidity of the frame members, the self-adjusting prostheses do not overcome many of the disadvantages of other types of rigid ring prostheses.
• U.S. Pat. No. 4,055,861, issued to Carpentier on Nov. 1, 1977, teaches an annuloplasty ring prosthesis having a flexibility between the completely flexible rings discussed above and the various types of rigid ring. The ring of Carpentier is deformable to an equal degree and simultaneously in all directions and preferably has the elasticity of an annular bundle of 2 to 8 turns of a cylindrical bristle of poly(ethylene terephthalate).
• While rigid and semi-rigid annuloplasty rings eliminate the bunching caused by flexible rings, the restrictive nature of such rings is generally detrimental to the valve's ability to open and close normally. It thus remains an object of the invention to provide a surgical means for reshaping a deformed or dilated heart valve annulus having none of the above described drawbacks associated with known annuloplasty ring prostheses.
• For use in annuloplasty of heart valves, as in other applications, it is desirable that a suture guide be entirely flexible, light weight, and compliant while having sufficient strength to withstand stress placed upon the sutures sewn through and around it. However, an entirely flexible suture guide cannot prevent bunching of the tissue in the draw-string effect described above and thus cannot assure that the suture line and the tissue into which it is placed will maintain any desired dimension, for example, a desired circumference. Therefore the need exists for a means of temporarily providing rigidity and fixed dimension to the suture guide during the surgery, but rendering the suture guide freely flexible once the surgery has been accomplished.
DESCRIPTION OF THE DRAWINGS
• The present invention may be better understood and the advantages will become apparent to those skilled in the art by reference to the accompanying drawings, wherein like reference numerals refer to like elements in the several figures, and
• FIG. 1 is a perspective exploded view of a flexible suture guide mounted on a rigid holder assembly in accordance with an embodiment of the invention
• FIG. 1A is a top view in partial cross-section of a length of a flexible suture guide in accordance with the present invention.
• FIG. 1B is a top view in partial cross-section of the flexible suture guide of the present invention sutured into a ring configuration.
• FIG. 2 is an exploded view of the guide mount portion and lower part of the handle portion of the holder assembly ofFIG. 1 without the suture guide.
• FIG. 3 is a perspective view of a flexible suture guide of the present invention mounted on the assembled guide mount and lower handle portions seen inFIG. 2.
• FIG. 4 is a cross-sectional view of the assembled guide mount and lower handle portions ofFIG. 3 along line4-4.
• FIG. 5 is a top view of the guide mount seen inFIG. 3 with a flexible suture guide tautly secured thereto.
• FIG. 6 is a perspective view of a guide mount in accordance with another embodiment of the invention.
• FIG. 7 is a cross-sectional view of a suture guide having a lenticular cross-sectional shape in accordance with another embodiment of the invention.
• FIG. 8 is a side perspective sectional view of a handle assembly in accordance with another embodiment of the invention.
• FIG. 9 is a bottom view of the handle extension of FigureFIG. 10 is a top view of the housing ofFIG. 8.
• FIG. 11 is a perspective view of a suture guide holder in accordance with another embodiment of the invention.
• FIG. 12 is an exploded view of the guide mount portion and lower handle portion of the suture guide holder ofFIG. 11.
• FIG. 13 is a top view of the guide mount portion of the suture guide holder ofFIG. 11.
• FIG. 14 is a perspective view of a linear suture guide holder in accordance with another embodiment of the invention.
• FIG. 15 is a perspective view of the suture guide holder ofFIG. 14 with a suture guide attached.
• FIG. 16 is a perspective view of a circular suture guide holder in accordance with another embodiment of the invention.
• FIG. 17 is a perspective view of the suture guide holder ofFIG. 16 with a suture guide attached.
• FIG. 18 is a cross-sectional view of the suture guide and holder ofFIG. 17 taken along line18-18.
SUMMARY OF THE INVENTION
• The present invention overcomes the above discussed disadvantages by providing an assembly for holding a substantially flexible suture guide in a substantially taut position for placing a suture line having a predetermined dimension. When attached to the holder assembly, the flexible suture guide assumes a shape or geometry, such as a circumference, that conforms to the shape or geometry of that portion of the body organ or vessel that is being sutured. The holder assembly can be formed to hold the suture guide in any desired shape, whether straight, curvilinear, or a combination of the two and the suture guide can be either biodegradable or permanently implantable. Thus the surgeon undertaking reconstructive surgery is aided in achieving a suture line of any desired shape, geometry and/or dimension.
• The assembly includes a holder portion having a surface against which the suture guide is positioned and held tautly in a fixed shape, geometry and/or dimension. More particularly, the holder assembly includes a body having an outwardly facing surface, generally flat, against which the suture guide is tautly positioned so that the suture guide assumes the shape, geometry and/or dimension desired for the suture line. Preferably, this surface is formed with at least one depression for receiving a portion of the suture guide. The assembly further includes a detachable handle and a mechanism for releasably binding the suture guide to the surface.
• The flexible suture guide used with the assembly of the invention comprises a generally elongated flexible body element having an internal flexible rib encased within a biocompatible covering, such as a woven cloth material. The suture guide can be formed of either biodegradable or non-biodegradable materials depending upon whether its purpose is to serve as a permanent support to prevent tearing out of the sutures placed through it or whether the suture-supporting function is to be a temporary one. In addition to its function as a post-surgical support for sutures, during surgery when used in combination with the holder disclosed herein, the suture guide serves as a rigid support and template by which the surgeon controls the length of the finished suture line. For instance, if the task is to suture together two ends of a bowel from which a section has been removed, the combination of suture guide and holder assure that the circumference of the surgical jointure is substantially similar to the circumference of the nearby regions of the colon, rather than smaller or larger.
• Therefore, the holder device is designed to lend a temporary rigidity or tautness to the suture guide while lending to it a shape selected to facilitate the suturing task. For instance, when the task is to place a line of sutures around the circumference of a curvilinear surface, the holder is designed to fit around at least a portion of the circumference while holding the suture guide against the said circumference to aid the surgeon in making a surgical jointure that-does not distort the said circumference.
• In use, the suture guide is releasably retained against the outwardly facing body surface by a means for releasable attachment, for example one or more threads, pieces of Velcro™, and the like, placed so that the suture guide lies along and temporarily substantially assumes the shape of the body. The means for attachment may also be a biodegradable adhesive having the capacity to firmly attach the suture guide to the holder body for sufficient time to complete the surgery, but having the capacity to dissolve or be dissolved once the suture line has been placed. In one embodiment, the thread attaches the suture guide to the body surface at least at two points, for example at its extreme ends, by passing at least partially through the suture guide and about the body, i.e., by means of an in and out stitch or stitches.
• The means for releasable attachment of the suture guide to the body must be such that the suture guide can be released from the body once the suture line has been placed by the surgeon without disturbing the sutures sufficiently to cause dislocation or tearing of the sutures through the tissue. For example, if the means f or releasable attachment is one or more threads, a portion of the thread(s) affixing the suture guide to the body can be positioned to be cut by scissors, or the like, to freely release the suture guide from the body. When the thread or threads are cut or otherwise ruptured, the suture guide is freely released from the body.
DESCRIPTION OF THE PREFERRED EMBODIMENTS
• The present invention is directed to a holder assembly for holding a substantially flexible, implantable suture guide in a substantially taut position for suturing along a suture line having a desired shape or dimension, such as the desired circumference to which an enlarged heart valve annulus is to be reduced by the formation of pleats about the base of the valve annulus. The suture guide of the invention is formed from a freely flexible rib encased within a woven cloth covering. In use, the flexible suture guide of the invention is held taut by the holder assembly and in a configuration determined by the shape of the holder assembly while the surgeon uses the support provided by the taut suture guide to evenly place the sutures and to draw the tissue by means of the sutures passed through the suture guide into a suture line having a shape substantially similar to that of the suture guide and holder. For example, for use in annuloplasty, the holder assembly can be C-shaped so that the suture guide temporarily affixed thereto assumes a C-shaped configuration. The suture guide can then be sutured to the base of a heart valve annulus so as to restrict the circumference of a dilated and/or deformed valve annulus to a more normal one. When the suture guide is released from the holder, it will assume any shape that that portion of the body organ or vessel assumes in accordance with the dynamic function of the organ or vessel.
• Generally the guide mount assembly includes a guide support formed with a shape similar to that of the desired suture line, as in the above example wherein the holder assembly is in the general shape of the valve annulus about which the suture guide is to be surgically placed to assist in holding pleats in the walls of the annulus. The suture guide is mounted along at least a portion of this guide support, for example along a straight or a curved portion.
• The holder assembly allows the surgeon to properly position the suture guide while the suture guide is used to draw the sutures and associated tissue into the desired configuration during the suturing process. The freely flexible suture guide is given temporary rigidity during surgery by the detachable holder assembly, thus lending precision to the surgeon in controlling the placement and location of the stitches in the suture line. In an annuloplasty, for example, the potential for forming multiple plications as the circumference of the valve annulus is adjusted is thus greatly reduced.
• Referring now toFIG. 1A, thesuture guide10 is an elongate, flexible member of a predetermined dimension. Due to its flexibility, the length ofsuture guide10 can be manipulated to assume any desired shape, ie., circular, C-shaped, straight, curvilinear or a combination of curvilinear and straight segments. InFIG. 1B,suture guide10 is shown as shaped into a ring by suturing the two ends together with sutures11. As shown inFIG. 1A,suture guide10 comprises a substantially flexibleinner rib14 encased within covering16.
• Rib14 comprises a flat, rod-like or tubular piece of biocompatible resilient, flexible material, such as mylar or silicone rubber.Rib14 can also contain a substance opaque to x-rays, for example, about 10 to 15 weight percent, preferably 13 weight percent, of barium sulfate so that the location of the suture guide can be determined in post-operative x-rays. Theouter covering16 is formed from any biocompatible material having sufficient strength to serve as an anchor to sutures without tearing and sufficient flexibility to be formed into a tight covering forrib14 without restricting flexibility ofsuture guide10. Preferably, theouter covering16 is a woven cloth having a nap to encourage tissue ingrowth, for example a dacron velour. This outer covering16 is tightly wrapped and sewn aboutframe14 so as to completely encase it. The thickness of theouter cloth16 is sufficient to allow the surgeon to pass a suture therethrough.
• FIG. 1 shows an exploded view of one embodiment of a holder assembly to which a suture guide is mounted, as seen generally at12 and10 respectively. Theholder assembly12 includes aguide mount assembly18 and handleassembly40 comprising ahandle42 andhousing44.
• FIGS. 2 through 5 illustrate in greater detail theguide mount assembly18 and how thesuture guide10 is mounted thereon.Guide mount assembly18 includes aguide support20. For illustrative purposes, thesuture guide assembly18 here-shown is one intended for use in plication of a distended heart valve annulus. Therefore facing edge ofguide support20 is generally C-shaped or annular, having a shape and circumferential dimension similar to that the surgeon desires to achieve in the human heart annulus by means of annuloplasty surgery. More particularly,support20 is generally lenticular, having a C-shapedportron28, with its ends connected by astraight side30.
• Thesuture guide10 is fitted into a groove ortrough32 located about the curved C-shapedportion28 of theguide support20Trough32 is dimensioned to receive a portion of thesuture guide10, as best seen inFIG. 4. The positioning of thesuture guide10 within thetrough32 conformsguide10 to the shape of theguide support20 while exposing a substantial portion of the covering16 outside of thetrough32 to allow the surgeon to pass a suture therethrough.
• In the embodiment shown inFIGS. 2-5, theguide mount assembly18 also includes acentral support hub22 to which theguide support20 is attached by a multiplicity of integrally formed spokes, preferably three, one of which is seen at24. The arrangement ofmount assembly18 including, in this instance, acurved guide support20 withhub22 andspokes24, allows the surgeon to visually observe the heart valve during the suturing process.Central support hub22 is formed with anannular groove36. Thisgroove36 is formed proximate thatend34 ofhub22opposite guide support20, and defines apost member38. That portion ofhub22 remaining on the side of thegroove36 opposite theguide support20, andhub end34, includes an inwardly tapering peripheral surface, as seen generally at35. Thehub22 also includes anopen bore37 through which is fitted acylindrical plug39. Theplug39 is dimensioned to extend out from both sides of thebore37. The purpose of taperedsurface35, and theplug39 will be described hereinafter.
• As is further seen inFIG. 1, thehandle assembly40 includes anelongated handle42 havingend54 mounted tohousing44. Whilehousing44 may be integrally formed at theend54 of thepost42, preferably end54 is formed with outwardly facing threads that threadably mate with threads formed along a surface of anopening59 formed in the top of thehousing44. The opposite end ofpost42 is formed with an external etchedsurface52 to assist the surgeon in grippingpost42. In another embodiment, end54 ofpost42 andopening59 ofhousing44 can be formed so thatend54 can be press fit intoopening59.
• Housing44 is a thimble-shaped structure having acircular wall60 defining acavity46. As seen better inFIG. 4,cavity46 is open at one side, seen generally as opening45. The inner surface of thecircular wall60 inwardly converges a short distance from theopening45. Thecavity46 is generally wide enough at theopen side45 to snugly receivehub22, but theplug39 extends sufficiently outward fromhub22 to prevent passage throughopen side45 intocavity46.Wall60 is formed with two J-shaped notches, seen at48 and49 inFIGS. 2 and 3. These J-shapednotches48 and49 are formed and positioned to respectively receive the ends of theplug39 extending outward from thehub22. The shape of thenotches48 and49 defines a landing50 between the long and short-legs of each notch.
• Handleassembly40 is coupled to theguide mount assembly18 by insertingend34 of thehub22 into thecavity46, with one of the outwardly extending ends of theplug39 passing through a respective one of the J-shapednotches48 and49. The taperedsurface35 of thehub22 engages the inwardly tapering surface of thewall60. This causes a slight compression of thehub end34, resulting in a spring force. The spring force acts to restrain the movement of the outwardly extending ends of theplug39 through the larger legs of the J-shapednotches48 and49. Additional exertion moves the ends ofplug39 through the larger legs of J-shapednotches48 and49, with rotation ofhandle40 passing the outward ends ofplug39 across thelandings50 and into the smaller leg of the J-shapednotches48 and49.
• The spring force established by the slight compression of thehub end34 maintains the coupling betweenhousing44 and guidemount assembly18. Thehandle40 is decoupled from theguide mount assembly18 by reversing the described procedure.
• One embodiment of the means for releasably attachingsuture guide10 to guidesupport20 ofguide mount assembly18 is seen inFIG. 5.Guide support20 is formed with twoapertures66 and68 extending throughguide support20 and communicating withgroove32. The exact positioning ofapertures66 and68 is not critical. As illustrated,apertures66 and68 are formed along the straight portion ofguide support20, at a location proximate two of thespokes24.
• Oneend71 of a cord orsuture thread70 is passed through one of the apertures, as illustratedhole66, and tied off onguide support20. Theother end73 ofsuture70 is passed through the body of suture guide10 from one end to the other. Thisend73 is then passed first throughhole68 and then through and tied off athole66. Aftersuture guide10 is sutured into position during surgery, i.e., about the valve annulus, that portion of thesuture70 betweenapertures66 and68 is snipped or cut in two.Suture70 passes out ofsuture guide10 by withdrawing thehandle assembly12.
• In accordance with another embodiment (not shown), thefirst end71 is tied off athole66, with thesecond end73 passed first through one end of thesuture guide10, and then brought back across and passed through the other end ofsuture guide10, throughhole68 and again tied off athole66. Removal ofsuture70 is accomplished by snipping the suture in two at any point between the two holes and withdrawing it.
• An alternative embodiment of the guide mount assembly80 as seen inFIG. 6 includes aguide support82 having an open C-shaped side64 but no straight side joining the ends of the C. Except for the stated difference in shape of theguide support82, guide mount assembly80 inFIG. 6 includes elements similar to those described for the suture guide ofFIG. 5 (as is indicated by the prime of the previously provided element number), and will be described in no further detail herein. In this embodiment of guide mount assembly80, the means for releasably attaching the suture guide to the guide support is a suture (not shown) positioned by tying off as described above across an open space betweenholes68 and66′ (not shown).
• In a preferred embodiment of the invention, thehandle assembly40 is tethered to theguide mount assembly18. As seen inFIG. 1, this tethering is performed by connecting one end of a lanyard, seen generally at100, to thehandle assembly40 and the other end of thelanyard100 to theguide support20, for instance to one ofspokes24.Lanyard100 allows a surgeon to detach thehandle assembly40 from theguide support20 during the suturing procedure to get a clearer view of the surgical site. By tetheringhandle40 to theguide mount assembly18, the risk of the surgeon leaving theguide support20 in the patient after completion of the surgical procedure is greatly reduced.Lanyard100 also allows the surgeon to easily remove theguide support20 after the handle has been detached.
• In a still further preferred embodiment, ahandle assembly40 is modified to house a spool of suture or string that acts like a tether for the guide mount assembly. The tether is attached at opposite ends to the handle assembly and the guide mount assembly respectively and automatically spools out of the handle assembly when the handle is disconnected from the guide mount assembly.
• This preferred embodiment is better seen in the severalFIGS. 8 through 10. The lower portion of a handle assembly in accordance with this embodiment is seen inFIG. 8 at90. Handleassembly90 includes ahousing92, ahandle extension94, and ahandle post96.
• Housing92 includes a pair of opposing J-shapednotches98 and99 that function similarly to the J-shapednotches48 and49 described above. Thehandle extension94 is fastened to the lower end of thehandle post96 in any suitable manner. As shown, thehandle extension94 includes at one end abore102 for receiving thelower end104 of thehandle post96.End104 of the handle post may be held inbore102 by welding, stamping, or by providing the respective members with interlocking threaded surfaces. Accordingly, neither of these structures of thehandle assembly90 will be discussed in any greater detail.
• The main distinction to the previously described embodiment is that thehandle assembly90 is formed to carry a spool of suture, seen generally at106. Thissuture spool106 is housed in abore112 formed in thehandle extension94. Handleextension94 andhousing92 are formed to releasably fit together. Handleextension94 andhousing92 includemating collars108 and110, respectively.Collar108 is formed with agroove114 that receives atongue116 extending upward fromcollar110.Tongue116 is formed with acentral aperture122, and two opposing cut-aways118 and120 that extend out in opposite directions from thisaperture122.
• Each of thecollars108 and110 possesses four apertures. Apertures126-129 ofcollar108 align with apertures130-133 ofcollar110 when thehandle extension94 andhousing92 are fitted together.
• Suture spool106 comprises a length of suture wound into a cylindrical configuration alonglower end104 ofhandle post96, which fits intobore112. The opposite ends of this suture length are tied to thetongue116 and thehandle extension94. One end of the suture is drawn through the central aperture of122 and tied totongue116, as seen at115. The opposite end of the suture is drawn through anopening124 extending from thebore112 through thehandle extension94 and is tied around thehandle extension94, as seen at117. It should be noted that for the purpose of this invention, the meaning of the term “suture” shall include any cord, string or filamentous material useful for tethering thehousing92 to thehandle extension94.
• Handleextension94 andhousing92 are fitted together by placing thetongue116 into thegroove114. Sutures are run through aligned apertures to hold thehandle extension94 andhousing92 together. For example, onesuture134 is passed throughapertures126 and127 ofhandle extension94 andapertures130 and131 ofhousing92, while asecond suture136 is passed throughapertures128 and129 ofhandle extension94 andapertures132 and133 ofhousing92.
• Thehandle assembly90 of this embodiment is coupled to theguide mount assembly18 as stated above. Thehandle post96 is removed from thehousing92 by cutting thesutures134 and136 and pulling thehandle extension94 away from thehousing92. Pulling away thehandle post96 unravels thesuture spool106. After the suture-guide is sutured into position along the suture line, i.e., about a heart valve annulus, the suture(s) holding the guide mount assembly to the suture guide is cut. The guide mount assembly is then removed by pulling on thehandle post96.
• In another embodiment of the invention, shown inFIGS. 11-13,handle assembly140 is also modified to house a spool of suture or string that acts like a tether for theguide mount assembly142. Referring toFIG. 11,handle assembly140, includeshousing144, handlepost146, and anenlarged handle portion148. Handlepost146 is preferably made of a malleable metal or other material that allows the surgeon to bend the handle to the desired angle while using the suture guide holder assembly. Theenlarged handle portion148 allows the surgeon to grip the handle more easily and also makes it easier for the surgeon to maneuver the suture guide holder into the surgery site.Housing144 is releasably attached to guidemount150 as will be described in more detail with reference toFIG. 12.Suture guide152 is releasably attached to guidemount150 by threads or sutures (not shown) in a manner which will be described with reference toFIG. 13.
• Referring toFIG. 12,housing144 includes bore154 for receivinghandle post146. The end ofhandle post146 may be held inbore154 by a press fit or friction fit, by welding, or by providing the respective members with interlocking threaded surfaces.Housing144 also includes a pair of opposingslots156 for receivingdog ears158 of thesuture spool160.Suture spool160 includes a length of suture orthread162 wound into a cylindrical configuration alongspindle post164. One end of thesuture162 is tied to an aperture (not shown) inupper end166 ofsuture spool160. The other end ofsuture162 is affixed tohub168 ofguide mount150. Specifically, suture162 passes down throughaperture170, up throughaperture172, and is tied off ataperture172. The lower end ofspindle post164 has a pair of opposingnotches174 formed therein which are sized to be received bybore176 ofhub168.Spindle post164, therefore, is press fit or friction fit intobore176.
• Suture spool160 is housed within the interior cavity (not shown) ofhousing144 and is held in place whendog ears158 snap fit into opposingslots156.Housing144 withsuture spool160 in place is then releasably attached to guidemount150 by sutures orthreads178 and180 shown inFIG. 11. Suture180 passes through a pair ofapertures182 inhousing144 and a pair ofapertures184 inguide mount150 as illustrated bydotted lines186 inFIG. 12. Suture178 passes through a pair ofapertures188 inhousing144 and a pair ofapertures190 inguide mount150 as shown by dottedlines192 inFIG. 12.
• Once the suture guide and guide mount assembly has been placed at the surgery site, the surgeon can remove the handle if desired by cutting sutures orthreads178 and180 at the location of the cutting guides194 and196 shown inFIGS. 11 and 12. Cutting guides194 and196 consist of a raised platform with ashallow groove195 formed therein through which the suture passes and adeeper groove197 formed in the platform perpendicular to the shallow groove through which scissors or other cutting tools can be inserted to clip or cut the suture at that location. When the sutures are cut and the handle is removed,spool160 remains withinhousing144 andsuture162 remains attached tohub168. As the handle is pulled away from the guide mount, the suture or thread spools offspindle post164 thereby providing a tether for removal of the guide mount after the suture guide has been detached from the guide mount and the surgery has been completed.
• Referring toFIG. 13,suture guide152 is releasably attached to guidemount150 by sutures orthreads198,200 and202.Suture198 is tied off ataperture204 and then passes through one end of the suture guide and up throughaperture206 over cuttingguide208 down throughaperture206 again, throughsuture guide152, throughaperture209, then up throughaperture210 where the other end ofsuture198 is tied off.Suture200 is at one end tied off throughaperture210 and then passes under theguide mount150 throughaperture211, throughsuture guide152 and up throughaperture212, across cuttingguide214 and back down throughaperture212. Suture200 then passes throughsuture guide152 again, throughaperture215 and up throughaperture216 where it is tied off. Finally,suture202 is tied off at one end ataperture216 and passes undersuture guide150 throughaperture217, throughsuture guide152, up throughaperture218, across cuttingguide220, down throughaperture218 again where it passes throughsuture guide152 and up throughaperture222 where it is tied off.
• Apertures224 and226 disposed inguide mount150 at opposite ends of thesuture guide152 are used to temporarily attach each end ofsuture guide152 to each end of theguide mount150 to hold the suture guide in place during the process of threadingsutures198,200 and202 through the, apertures of the guide mount and the suture guide. Once the threading ofsutures198,200 and202 is complete, the sutures at224 and226 are then removed. The sutures at224 and226 are shown for illustration purposes inFIG. 11 at223 and225.
• Referring toFIG. 13, cutting guides208,214 and220 consist of a raised platform with ashallow groove228 formed therein through which the suture passes and adeeper groove230 formed in the platform perpendicular to the shallow groove through which a cutting tool may pass in order to cut the suture at the location lying over the deeper groove. The deeper groove is closed at one end by astop232 so that the tip of the cutting tool or scissors cannot pass beyond that point. This stop prevents the cutting tool from dipping down into theopen space234 between the spokes ofguide mount150 and accidentally cutting the tissue of the patient.
• When the surgeon is ready to release the suture guide from thesuture guide mount150 he merely snips thesutures198,200 and202 by passing the cutting tool into the cutting groove of the cutting guides. When the sutures have been snipped at all three locations, the guide mount can be retrieved by pulling on the tether or otherwise removing it and sutures198,200 and202 are removed with theguide mount150 since they are tied off on the guide mount.
• Referring toFIGS. 14 through 18, there are shown two additional embodiments of suture guide holders for holding a suture guide.FIGS. 14 and 15 illustrate a linear suture guide holder for placing a linear suture guide.FIGS. 16, 17 and18 illustrate a circular or ring-shaped suture guide holder for placing a circular suture guide.
• Referring toFIG. 14, the linear suture guide holder has adetachable handle240 of the type shown inFIG. 2 and linear-shapedguide mount242. However, the handle embodiment with the tether illustrated inFIGS. 8 and 12 could also be used.Guide mount242 has a linear groove ortrough244 into whichsuture guide246 is fitted as shown inFIG. 15.Apertures248 formed inguide mount242 are used to suture the suture guide to the guide mount as shown inFIG. 15.Guide mount242 also includes cutting guides252 and254 at each end of the guide mount.
• Suture guide246 is tautly secured to thelinear guide mount242 bysuture250. One end ofsuture250 is tied off at aperture248a, passes throughsuture guide246 up throughaperture248bcross cutting guide252 down through aperture248cthroughsuture guide246 up throughaperture248dwhere it is tied to a second length ofsuture256.Suture256 is threaded down throughaperture248ethroughsuture guide246 up throughaperture248facross cuttingguide254 down through aperture248gthroughsuture guide246 and up throughaperture248hwhere it is tied off. Thus, as in previous embodiments, when the surgeon is ready to release the suture guide from the suture guide holder, he merely inserts the cutting tool in the cuttinggrooves252 and254 andcuts sutures250 and256 at that location.Suture250 and256 are then removed with thesuture guide mount242. The linear suture guide shown inFIGS. 14 and 15 would be used for any surgical procedure in which the incision is a substantially straight line. Thesuture guide mount242 can be any desired length and thesuture guide246 can extend the full length of thesuture guide mount242 as shown inFIG. 15 or could be of a shorter length and sutured to just a portion ofsuture guide mount242. If the surgeon desires a suture guide with a hook or curved end, the suture guide could extend around the edge ofsuture guide mount242 to provide one or two curved or hooked ends.
• Referring toFIG. 16, there is shown a circular suture guide holder which would be useful for suturing two blood vessels or other vessels, such as intestines, together. It would also be useful for bowel and bronchial resection. The suture guide holder has ahandle260 which in this embodiment is not shown to be detachable. However, any of the various handle embodiments illustrated previously could be utilized, including the tethering concepts. Thesuture guide mount258 is ring shaped with a groove ortrough260 formed on the interior cylindrical surface of the ring. The groove ortrough260 is shaped to receive acircular suture guide261 as shown inFIG. 17.Suture guide mount258 has a plurality ofapertures262 evenly spaced about its circumference for use in suturing thesuture guide261 to the suture guide holder as shown inFIG. 17.Suture264 is threaded through the apertures and through the suture ring in a manner similar to that described with reference toFIGS. 14 and 15 and will not be further be described in connection with this embodiment. Suture264 can be clipped at two locations such as at266 and268 in order release the suture guide from the suture guide holder. Alternatively, cutting guides can be provided as shown in the embodiments previously described and illustrated.
• FIG. 18 shows a cross section of the suture guide holder with the suture guide attached thereto taken along line18-18 ofFIG. 17.FIG. 18 illustrates howgroove260 engagessuture guide261 and depicts rib263 and theouter covering265 of the suture guide.
• Various shaped suture guide holders, C-shaped, linear and circular, have been described and illustrated in the figures, however, in accordance with the present invention, the suture guide holder can be constructed in any desired shape depending on the surgical procedure involved. For example, the suture guide solder could be curvilinear for stomach reduction surgery or for certain cosmetic surgeries when it is necessary to place a suture line along an eyelid or an ear.
• While the preferred embodiments have been described, various modifications and substitutions may be made thereto without departing from the scope of the invention. Accordingly, it is to be understood that the invention has been described by way of illustration and not limitation.

Claims (33)

1-30. (Canceled)

31. An annuloplasty prosthesis delivery system, comprising:

an annuloplasty prosthesis;

a rigid body defining a surface against which the annuloplasty prosthesis is fitted and held in a shape substantially equivalent to at least a portion of the valve annulus, and an outer periphery of the annuloplasty prosthesis extends outward from the rigid body;

at least one suture secured to the rigid body and passing through the annuloplasty prosthesis tautly attaching the annuloplasty prosthesis about the surface;

a handle assembly including a distal housing, the distal housing releasably secured to the rigid body.

32. The system ofclaim 31, wherein the suture is secured at both ends to the rigid body with a portion exposed on the rigid body which, when severed, subdivides the suture into two pieces each affixed at one end to the body.

33. The system ofclaim 31, wherein the rigid body is formed with two holes that communicate with the surface and through which the suture passes.

34. The system ofclaim 31, wherein the rigid body has a C-shaped portion with its ends connected by a straight side.

35. The system ofclaim 34, wherein the annuloplasty prosthesis is fitted about the C-shaped portion of the rigid support body.

36. The system ofclaim 31 wherein the rigid body is formed with only an open C-shaped side about which the annuloplasty prosthesis is fitted.

37. The system ofclaim 31, wherein the surface of the rigid body defines a groove dimensioned to receive a portion of the annuloplasty prosthesis.

38. The system ofclaim 31, wherein the rigid body includes an outer ring support and at least one spoke extending inward from the ring support to which the distal housing is releasably secured.

39. The system ofclaim 38, wherein the spoke includes a post member to which the distal housing is mounted.

40. The system ofclaim 39, wherein the post member includes a mechanical interlock releasably securing the distal housing to the post member.

41. The system ofclaim 31, further comprising at least one thread looped around a portion of both the distal housing and rigid body, wherein the distal housing is releasably secured to the rigid body by the thread, the thread having a section exposed on the distal housing that when severed releases the handle assembly from the rigid body.

42. The system ofclaim 41, further including a cutting guide formed on the distal housing over which the thread is exposed for severing.

43. An annuloplasty prosthesis delivery system, comprising:

an annuloplasty prosthesis;

a rigid body defining an outer edge about which the annuloplasty prosthesis may be fitted;

at least one suture tautly attaching the annuloplasty prosthesis about the edge and having a portion exposed on the rigid body which can be cut to release the annuloplasty prosthesis from the rigid body; and

a handle secured to the rigid body that may be removed during a surgical implant procedure to allow for easier visibility of the annuloplasty prosthesis.

44. The system ofclaim 43, wherein the suture is secured at both ends to the rigid body.

45. The system ofclaim 43, wherein the rigid body is formed with two holes that communicate with the outer edge and through which the suture passes.

46. The system ofclaim 43, wherein the rigid body has a C-shaped portion with its ends connected by a straight side.

47. The system ofclaim 46, wherein the annuloplasty prosthesis is fitted about the C-shaped portion of the rigid support body.

48. The system ofclaim 43, wherein the rigid body is formed with only an open C-shaped side about which the annuloplasty prosthesis is fitted.

49. The system ofclaim 43, wherein the outer edge of the rigid body defines a groove dimensioned to receive a portion of the annuloplasty prosthesis.

50. The system ofclaim 43, wherein the outer edge of the rigid body is defined on an outer ring support and at least one spoke extends inward from the ring support to which the handle is releasably secured.

51. The system ofclaim 50, wherein the rigid body includes a post member on the spoke to which the handle is releasably secured.

52. The system ofclaim 51, further comprising a mechanical interlock between the handle and post member.

53. The system ofclaim 43, further comprising at least one thread looped around a portion of both the handle and rigid body, the thread having a section exposed on the handle that when severed releases the handle from the rigid body.

54. The system ofclaim 53, wherein the handle includes a distal housing and cutting guide formed thereon over which the thread is exposed for severing.

55. A method of delivering and implanting an annuloplasty prosthesis at an annulus implant site, comprising:

providing an assembly of an annuloplasty prosthesis and a rigid body, the rigid body defining a surface about which the annuloplasty prosthesis may be fitted such that an outer periphery of the annuloplasty prosthesis extends outward from the rigid body, the annuloplasty prosthesis being tautly attached about the surface with at least one suture attached to the rigid body and passing through the annuloplasty prosthesis, the suture having a portion exposed on the rigid body;

coupling a handle assembly to the rigid body;

delivering the annuloplasty prosthesis/rigid body assembly to the annulus implant site using the handle assembly;

decoupling the handle assembly from the prosthesis/rigid body assembly and removing the handle assembly from the annulus implant site;

securing the annuloplasty prosthesis to the annulus while the annuloplasty prosthesis remains attached about the surface; and

severing the suture at the portion exposed on the rigid body and removing the rigid body and severed suture from the secured annuloplasty prosthesis.

56. The method ofclaim 55, wherein the suture is secured at both ends to the rigid body, and wherein severing the suture and removing the rigid body causes the severed ends of the suture to pull free from the annuloplasty prosthesis.

57. The method ofclaim 55, wherein the rigid body has a C-shaped portion with its ends connected by a straight side.

58. The method ofclaim 57, wherein the annuloplasty prosthesis is tautly fitted about the C-shaped portion of the rigid support body with the suture.

59. The method ofclaim 55, wherein the outer edge of the rigid body is defined on an outer ring support and at least one spoke extends inward from the ring support to which the handle assembly is releasably coupled, the method including viewing the annulus implant site through the rigid body.

60. The method ofclaim 55, further comprising a mechanical interlock between the handle assembly and rigid body and the method includes decoupling the mechanical interlock to decouple the handle assembly from the prosthesis/rigid body assembly.

61. The method ofclaim 55, further comprising at least one thread looped around a portion of both the handle assembly and rigid body, the thread having a section exposed on the handle assembly, the method further including severing the exposed portion of the thread to decouple the handle assembly from the prosthesis/rigid body assembly.

62. The method ofclaim 61, wherein the handle assembly includes a distal housing and cutting guide formed thereon over which the thread is exposed for severing, the method further including inserting a cutting tool in the cutting guide to sever the thread.

Images