US20060100487A1 - Surgical retractor with mounting rail - Google Patents

Abstract

A retractor assembly for retracting a surgical incision in a patient, having a plurality of perimeter mounting rails. The retractor having first and second generally opposed spreader arms movable relative to each other along a guide member connected thereto, through the actuation of a drive mechanism. Each of first and second spreader arms having respectively a first and second blade portion adapted to retract opposing edges of a surgical incision. The first and second spreader arms and guide member are provided with a mounting rail configured and sized for selectively mounting an instrument-positioning member thereto. The instrument-positioning member is adapted to cooperatively engage mounting rail on either of spreader arms or rack bar and is slidable along a length of the mounting rail when it is in an loosened configuration and adapted to resist any movement along the mounting rail when it is in a locked configuration.

Description

FIELD OF THE INVENTION
• The present invention relates to the field of cardiac surgery instrumentation and more specifically to the surgical method and apparatus optimized for coronary bypass operations.
BACKGROUND OF THE INVENTION
• Direct coronary artery revascularization on a beating heart was conducted, both experimentally and clinically, in the 1950's and the 1960's, without stabilization.
• Challenges associated with this surgical technique are as follows:
• • complete anastomosis is very difficult to achieve due to the motion of the beating heart;
  • the technique is limited to vessels of a minimum diameter—again due to difficulty in the anastomosis technique on a beating heart;
  • lifting of the heart for revascularization of posterior arteries results in a precipitous drop in arterial pressure;
  • the learning curve for surgeons performing this technique is very high, negotiating the learning curve may represent significant surgical morbidity and mortality.
• The development of the cardio-pulmonary machine for extracorporeal circulation (ECC) enables coronary operations on an arrested heart. This allows the surgeon to operate on a perfectly still heart and to manipulate the heart to expose the target artery.
• At the present time, the standard coronary artery bypass graft (CABG) procedure typically requires a full median sternotomy and extracorporeal circulation through a cardio-pulmonary machine.
• Even with the constant technological improvements achieved during the last twenty-five years, the advantages offered with ECC have been offset by morbidity and mortality related to the ECC itself. The inflammatory response, as well as systemic microembolisms generated by ECC, induce to some extent a dysfunctional state of the brain, lungs and kidneys, which tends to increase with the aging of the patient. Furthermore, evidence suggests that when ECC can be avoided, the left ventricular function is better preserved, thereby reducing risk of post-operative complications.
• As a result, alternate CABG procedures that do not rely on the use of ECC offer distinct advantages.
• Recently, minimally invasive surgery, involving a partial sternotomy or mini-thorocotomy, has generated much interest since it removes precisely the need for ECC. This surgery does, however, have its limitations. It is adequate for only one or two coronary bypass grafts. Moreover, it does not provide access to the posterior descending or circumflex arteries, and impairs both the anastomosis and the surgeon's vision due to the limited heart exposure.
• These limitations may lead to future, more-invasive surgical interventions through partial or full sternotomy, if “blockages” progress in those arteries which were not accessible via minimally invasive procedures.
• Therefore, partial revascularization may lead to re-intervention which not only represents a disadvantage to the patient but a financial burden to the health care system.
SUMMARY OF THE INVENTION
• It is therefore an object of the present invention to provide a surgical apparatus allowing to perform coronary surgery, in particular coronary artery revascularization, without the need for extra-corporeal circulation.
• It is a further object of the invention to provide a surgical apparatus to perform complete revascularization of coronary arteries without the need for extra-corporeal circulation.
• It is a further object of the invention to provide a surgical apparatus for performing coronary surgery, in particular coronary artery revascularization, on a beating heart
• It is a further object of the invention to provide a surgical apparatus for performing coronary surgery, in particular coronary artery revascularization, enabling grafting on all arteries of the heart and their respective branches, most particularly the right coronary (RC), the posterior descending artery (PDA), the left anterior descending artery (LAD) and diagonals, the branches of the circumflex artery (Cx) namely the obtuse marginal (1 through 4) and the postereo-lateral branches.
• It is a further object of the invention to provide a surgical apparatus for performing coronary surgery, in particular coronary artery revascularization, provided with positioning means being capable of being mounted in a plurality of locations on a sternum retractor or any other adequate support.
• It is a further object of the invention to provide a surgical a for performing coronary surgery, in particular coronary artery revascularity, simplifying the grafting process.
• It is a further object of the invention to provide a surgical apparatus for performing coronary surgery, in particular coronary artery revascularization, with reduced costs associated with shorter time of surgery, reduced costs of surgical equipment, reduced surgical staff, significantly reduced risk of medical complications, and shorter hospital recovery stay.
• It is a further object of the invention to provide a surgical apparatus for performing coronary surgery, in particular coronary artery revascularization, that is easy to utilize for surgeons and representing an evolution of current proven practice without the need for long retraining period.
• It is a further object of the invention to provide a surgical apparatus for performing coronary surgery, in particular coronary artery revascularization, enabling surgeons to operate on all patients, especially those not well suited to minimally invasive techniques or well suited to conventional coronary artery bypass grafting (CABG) with extra corporeal circulation (ECC).
• It is a further object of the invention to provide a surgical apparatus for performing coronary surgery, in particular coronary artery revascularization, with a risk reduced procedure for the patient, a cost effective solution to reducing health care expenses, and an ergonomic layout enhancing the efficiency of surgeons.
• It is a further object of the invention to provide a surgical apparatus for performing coronary surgery, in particular coronary artery revascularization, that is ergonomic, easy to deploy, easy to sterilize, and time efficient with respect to the multitude of attachments which might be needed during the course of open chest surgery.
• It is a further object of the invention to provide a surgical apparatus for performing coronary surgery, in particular coronary artery revascularization, which optimizes accessibility to all different arteries requiring grafting irrespective of variations in personal physiology from one patient to another.
• It is a further object of the invention to provide a surgical apparatus for performing coronary surgery, in particular coronary artery revascularization, that can be used with known types retractors, as a retrofit arrangement.
• Another object of the invention is to provide positioning means for a surgical apparatus, in particular a heart stabilizer for performing coronary surgery, particularly coronary artery revascularization, without the need for extra-corporeal circulation.
• Another object of the invention is to provide contacting means for a surgical apparatus, in particular a heart stabilizer for performing coronary surgery, particularly coronary artery revascularization, without the need for extra-corporeal circulation.
• Another object of the invention is to provide a sternum reactor for performing coronary surgery, particularly coronary artery revascularization, without the need for extra-corporeal circulation.
• As embodied and broadly described herein, the invention provides a surgical apparatus for coronary surgery on a patent comprising contacting means being capable of providing a mechanical force against at least a portion of the patient's coronary organs according to its positioning with regard to said organs, positioning means to set said contacting means in a given substantially stable spatial position and orientation within a given volume, said contacting means being pivotingly connected to a sternum retractor via said positioning means.
• This surgical apparatus enables performing coronary surgery, particularly coronary artery revascularization, without the need for extra-corporeal circulation. That is to say, the operation can be realized on a beating heart. There is no need to use a cardio-pulmonary machine, which considerably reduces the costs of the operation. Without extracorporeal circulation, mortality and morbidity rates are also reduced.
• The surgery and graft process can be performed by only one surgeon and one assistant, as opposed to standard coronary artery bypass graft surgery which usually requires two surgeons and a perfusionist for ECC.
• As embodied and broadly described herein, the invention also provides positioning means for a heart stabilizer for use in coronary surgery, said heart stabilizer comprising contacting means intended to provide a mechanical force against at least a portion of the patient's coronary organs according to is positioning with regard to said organs, said positioning means being intended to set contacting means in a given substantially stable spatial position and orientation within a given volume and being connectable in at least one location to a sternum rector, said contacting means being connectable to a movable free portion of said positioning means.
• The contacting means can therefore be positioned in an almost unlimited number of positions and orientations to facilitate the intervention on any artery. This also brings high flexibility, as any patent whatever the morphology may be, can be treated. Moreover, the adaptability of the apparatus facilitates the grafting process. For example, the right coronary artery is most accessible when the positioning means are mounted on the rack bar. The left anterior descending artery and diagonal arteries are most accessible when positioning means are mounted in the ending portion of the spreader arms. Access to the circumflex artery and posterior descending artery is enhanced when positioning means are mounted on the right side of the retractor, patient's view.
• Preferably, the positioning means comprise a sliding member providing relative movement between said sternum retractor and said positioning means. This provides great flexibility and facilitates the surgical manipulations.
• As embodied and broadly described herein, the invention also provides positioning means for a heart stabilizer for use in coronary surgery, said heart stabilizer comprising contacting means intended to provide a mechanical force against at least a portion of the patient's coronary organ according to its positioning with regard to said organs, said positioning means being intended to set contacting means in a given substantially stable spatial position and orientation within a given volume and being connectable in at least one location to a sternum retractor, wherein said positioning means comprise an articulation member for providing displacement of a member connected thereof with at least one degree of freedom, a positioning rod connectable to said articulation member, said contacting means being connectable to said positioning rod.
• More specifically, under this preferred embodiment, the positioning means comprise a second articulation member for providing displacement of a member connected thereof, with at least one degree of freedom, said positioning rod being connectable to said second articulation member. The articulation member can advantageously be made of a resilient material.
• In a specific example, the articulation member comprises at least one partly spherical member pivotingly maintaining a positioning rod member between two hollow cylindrical bodies. In another specific example, the articulation member comprises at least one partly spherical member pivotingly maintaining positioning rod member between two clamping members.
• In another specific example, the “quick-assembly” parts allow the positioning means to be placed in at least six different orientations with respect to the sternum retractor, and consequently the patient's heart: four orientations along the perimeter of the retracted chest cavity, and two cross-corner diagonal orientations. This maximizes the options for optimum accessibility to the target artery. It also provides the surgeon with flexibility during delicate surgical asks like suturing, as he has access to strategic sections of the chest cavity that are free from all devices.
• As embodied and broadly described herein, the invention also provides positioning means for a heart stabilizer for use in coronary surgery, said heart stabilizer comprising contacting means intended to provide a mechanical force against at least a portion of the patient's coronary organs according to its positioning with regard to said organs, said positioning means being intended to set contacting means in a given substantially stable spatial position and orientation within a given volume and being connectable in at least one location to a sternum retractor, wherein said positioning means further comprise an articulation member for providing displacement of a member connected thereof with at least one degree of freedom, a positioning rod connectable to said articulation member, a second articulation member for providing displacement of a second member connected thereof with at least one degree of freedom, a second positioning rod connectable to said second articulation member, said contacting means being connectable to said second positioning rod.
• As embodied and broadly described herein, the invention also provides contacting means being capable of providing a mechanical force against at least a portion of the patient's coronary organs according to its positioning with regard to said organs within a given volume and comprising two substantially elongated contacting arms defining therebetween an arterial window.
• As embodied and broadly described herein, the invention also provides a sternum retractor for use in coronary artery surgery, comprising: a rack bar extending transversally between the ending portions of a fixed spreader arm and a movable spreader arm, these arms both extending longitudinally in a direction substantially normal with regard to the rack bar, said movable arm being capable of being displaced along the rack bar and said spreader arms being provided with blades, contacting means intended to provide a mechanical force against at least a portion of the patient's coronary organs according to its positioning with regard to said organs, positioning means intended to set contacting means in a given substantially stable spatial position and orientation within a given volume and being connectable in at least one location to a sternum retractor said contacting means being connectable to a movable free portion of said positioning means.
• All interfaces are intended and designed to keep the open chest cavity as ergonomic and accessible as possible, free from all peripheral tubing and connectors. All interfaces, design features and components are easy to sterilize.
• The surgical equipment described herein can be used to perform multiple revasculariations on any of the coronary arteries or branches without repositioning the sternum retractor after initial deployment. The interfaces between the positioning means and the retractor are preferably designed to permit retractor spreader arm readjustment without disconnecting the positioning means setup. It can be used to perform multiple revasculariations by surgeons experienced in standard on-pump CABG with minimal training. It also can be used to perform revasculariations for both initial surgeries and reoperative cases.
• The surgical equipment described herein provides the surgeon with visibility equal to that of standard CABG. Furthermore, in cases where unforeseen complications develop during surgery, the method described herein is not disadvantaged with the delays and complications associated with conversion from a minimally invasive CABG technique to full open chest surgery in cases. It is also not required for the patient to be placed on single lung ventilation, as is the case in some minimally invasive techniques.
• The surgical apparatus described herein reduces the costs associated with standard CABG in particular in the following specific arm:
• • a cardio-pulmonary machine is not required;
  • a perfusionist to operate the cardio-pulmonary machine is not required;
  • less highly trained surgical staff is required to preform the surgery (one surgeon and assistant, compared to two surgeons);
  • reduced hospital stay is required be ECC is not used;
  • reduction in frequency of complications and associated costs;
  • reduction in operating time due to ergonomic design features of apparatus.
BRIEF DESCRIPTION OF THE DRAWINGS
• The invention will further be described, by way of example only, with reference to the accompanying drawings wherein:
• FIG. 1A is a perspective view illustrating a first embodiment of the surgical apparatus according to the invention;
• FIG. 1B is a perspective view illustrating working volume W and motion degrees of freedom of the surgical apparatus according to the invention;
• FIG. 2 is a top view of the embodiment illustrated inFIG. 1A;
• FIG. 3 is an exploded view of the first articulation member used inFIG. 1A;
• FIG. 4A is an exploded view ofFIG. 1;
• FIG. 4B is a cut away view of the articulation member illustrated inFIG. 4A;
• FIG. 4C is a side elevational view of the knob of articulation member illustrated inFIG. 4B;
• FIG. 5A is a perspective view illustrating a second embodiment of a surgical apparatus according to the invention;
• FIG. 5B is a perspective view (party cut away) of the articulation members used inFIG. 5A;
• FIG. 6 is a side elevational view of the embodiment illustrated inFIG. 5A;
• FIG. 7 is a variant of the embodiment inFIG. 5A;
• FIG. 8 is another variant of the embodiment ofFIG. 5A;
• FIG. 9 is a variant of the embodiments ofFIG. 1A andFIG. 5A;
• FIGS. 10A to10F are perspective views according to the invention;
• FIG. 11 is another embodiment of the surgical apparatus;
• FIG. 12 is a perspective view of a sternum retractor variant;
• FIGS. 13A to13F illustrate examples of several setting possibilities of the positioning members on a sternum retractor, as illustrated anFIG. 12;
• FIG. 14 is a perspective view partly exploded and schematically illustrating an example of a retrofit system according to the invention;
• FIGS. 15A to15F illustrate several examples of support members for retrofit systems according to the invention, as illustrated inFIG. 14;
• FIG. 16 is a perspective view illustrating a further embodiment of the surgical apparatus according to the invention, using easy to connect/disconnect articulation members;
• FIG. 17 is a fragmentary top view of a sternum retractor according to the invention;
• FIGS. 18A to18C are examples of variants of the embodiment described inFIG. 5A;
• FIGS. 19 and 20 illustrate variants of the embodiment ofFIG. 1A;
• FIGS. 21A to21D illustrate further variants of the embodiment ofFIG. 1;
• FIG. 22A is a perspective view of a sternum retractor illustrated inFIG. 1A;FIGS. 22B-22F illustrate examples of rail profiles used on a sternum retractor illustrated inFIG. 22A;
• FIGS. 23A and 23B illustrate perspective views of the surgical apparat according to the invention, in use during a coronary artery revascularization;
• FIG. 24 illustrates a push type configuration according to the invention;
• FIG. 25 illustrates a pull type configuration according to the invention;
• FIGS.26 to29 illustrate perspective views of contacting means according to the invention;
• FIGS. 30A to30G illustrate variants of contacting means provided with different types of attachment means;
• FIGS. 31A to31F illustrate variants of contacting means provided with dissent types of textures;
• FIG. 32 illustrates a variant of a positioning rod.
DESCRIPTION OF THE PREFERRED EMBODIMENTS
• The surgical apparatus according to the invention is provided to be used with a sternum retractor. Single purpose sternum retractors, which only serve to retract the patient's sternum and ribcage, are well known in the art. They are mainly used for retracting the mediastinum in order to person coronary artery revasculatizations, heart valve replacement, and other cardiac intervention.
• Such asternum retractor1 comprises arack bar2 extending transversally, a fixedspreader arm3, and amovable spreader arm4. Both arms extend longitudinally in a direction substantially normal with regard to the rack bar. Themovable arm4 can be displaced along the rack bar, using a crank5 activated by a pinion mechanism (not shown) throughshaft6. Twoblades7 are provided underneath the spreader arms.
• This invention introduces an improved retractor specifically designed to provide attachment interfaces for a variety of positioning means and any other equipment used during the course of open chest cardiac surgery.
• In broad terms, the surgical procedure ad to this invention consists of:
• • 1. Full or partial sternotomy;
  • 2. Isolation and removal of either internal saphenous vein(s) or of internal thoracic artery(ies);
  • 3. Strategic positioning and manipulation of beating heart with regard to the artery to be bypassed;
  • 4. Locally immobilizing and stabilizing the portion of the beating heart around the grafting site;
  • 5. “Pinching” the target artery upstream and downstream of occluded site to restrict blood flow during grafting;
  • 6. Grafting of bypass veins and/or arteries;
  • 7. Verifying blood flow through newly grafted bypass artery;
  • 8. Draining of chest cavity;
  • 9. Closing of chest cavity.
• In the course of an operation, a surgeon needs to perform certain tasks within the volume defined by therack bar2, thearms3 and4 and the chest cavity, such as reaching the target arteria, suturing, etc. The volume in which the surgeon needs to perform these different tasks, will be called herein the working volume W. This volume also comprises a buffer zone extending beyond the perimeter of open chest cavity (seeFIG. 1B). The present invention provides positioning means20 allowing the surgeon or an assistant to place and secure a specific surgical instrument, namely the contactingmeans30, within this working volume, to perform revasculatizations on a beating heart more easily, quickly and do. The above mentioned type of retractor is preferably used to set the positioning means. However, other retractor types, for example chest rector or thoratic retractor, or other supports, for example a bed or a crane, can also be used.
• FIG. 1A illustrates a first embodiment in which the positioning means comprise a unique articulation member.FIG. 1B schematically depicts the flexibility and versatility of the surgical apparatus through the motion degrees of freedom listed below:
• • S displacement ofarticulation member50 alongrails40 of reactor;
  • R1 axial displacement along centerline offirst positioning rod60 througharticulation member50;
  • R2 displacement along centerline ofsecond positioning rod70 througharticulation member80;
  • α rotation about centerline ofarticulation member assembly50;
  • A1 angular displacement through rotation α;
  • β angle between centerline offirst positioning rod60 and centerline ofarticulation member assembly50;
  • P1 displacement along z axis achieved through rotation β;
  • ε angle betweenfirst positioning rod60 andsecond positioning rod70 in the plane formed by their two axes;
  • φ angular rotation ofsecond positioning rod70 in the plane normal to the centerline offirst positioning rod60;
  • A2 angular displacement of contactingmeans30 about the centerline ofsecond positioning rod70.
• The fixed spreader arm and movable spreader arm are preferably provided withrails40, disposed axially along said arms, for example on top ofblades7. Any known type of rail can be used.FIGS. 22A to22F illustrate various examples of rail profiles. Other types can also be used like, for example, a rod type rail.
• Afirst articulation member50 is slidingly and pivotingly engaged in said rails. This first articulation member is easily removable from the rails and can therefore be placed on any of the rails. It can also be set in any axial position on said rails or, alternatively on the rack bar slot as shown onFIG. 17. This first articulation member also serves as a support for afirst positioning rod60. Therod60 and thearticulation member50 are arranged to allow the free end portion of the rod to be placed in any position within said working volume W. Thisrod60 can be easily displaced first with the sliding motion S of thearticulation member50 along any of said rails40, corresponding to a displacement along the Y axis. Secondly, with an angular motion A1 of thearticulation member50 about its own centerline, therod60 can be placed along a given angle α. Thirdly, therod60 can be shifted axially (R1) though themember50 in order to get doser or farther from said member. Finally, themember50 can also provide a first height positioning P1, allowing therod60 to pivot vertically, to reach a given β angle.
• The ending portion of this first positioning rod within the working volume is provided with asecond articulation member80. This second articulation member mainly serves as a holding member for asecond positioning rod70. One ending portion of this second positioning rod is provided with a contactingmeans30. This second articulation member allows advantageously further types of displacements; first, an axial sliding motion R2 to allow the positioning of the contacting means30 along the centerline axis ofrod70, within the working volume W; second, an angular displacement A2 of a contactingmeans30 about the centerline ofpositioning rod70; third, an angular orientation of thesecond positioning rod70 with respect tofirst positioning rod60 through angle ε; fourth, an angular rotation φ of thesecond positioning rod70 in a plane normal to the centerline of thefirst positioning rod60. According to a preferred variant,member50 provides a coarse adjustment whereasmember80 provides a fine adjustment.
• In this way, the contacting means can be placed very accurately in practically any position and orientation within said volume W. The position is preferably obtained with displacement S, R1, A1, P1, and R2 The orientation of the contacting means is mainly achieved with the displacement A1, A2, P1, φ and ε. Of course, many variants of the invention can be provided, only by adding or removing a given articulation or displacement possibility. For example, thefirst transmission member50 could be provided so thatrod60 rotates along its own axis, or contactingmeans30 could be provided with a pivot at its junction withrod70, etc. Furthermore, the positioning means extends advantageously beyond the perimeter of the open chest cavity.
• Different types of articulations may be used for thefirst articulation member50 andsecond articulation member80. For example, known types of articulations like resilient articulations or spherical bearing articulations, etc., may be used without departing from the spirit of the invention. The articulations used with the embodiment illustrated inFIG. 1A are shown in details inFIGS. 3 and 4A.
• FIG. 3 illustrates an exploded view of an example of a first articulation member, such as the one used in the embodiment ofFIG. 1, withreference50. A hollowcylindrical body55 is provided along its longitudinal wall with two oppositeoval windows551. Atop cover552 on the upper end is provided with acentral aperture553. A bottom hollowcylindrical member52 is provided with two oppositelateral openings522. The front portion is open to cooperate with other components. The inner top and bottom portions are shaped with oppositeconcave profiles524 and523. Two opposite semi-sphere likeadaptors56 and54 are provided with a cylindrical hollow. A top hollowcylindrical member53 is provided withlateral openings531 corresponding substantially to those of the hollowcylindrical member52 so that it can cooperate with thebottom member52. On top of member53 ascrew member533 is provided. The inner bottom portion is shaped with a concave profile corresponding to the lower semi-sphere like adaptor. The positioning rod is engaged through the hollow portion of the two semi-sphere like adaptors to create an assembly.
• This assembly is placed in the cavity formed by the cooperatingmembers52 and53. The upper andlower adaptors56 and54 cooperate respectively with the concaveinner portion524 and the concaveinner portion532. This allows easy pivoting of the rod, not only vertically, but also laterally. All these components are maintained together in thecylindrical body55. The rod extends throughwindows551.Screw member533 extends throughaperture553 and cooperates with setscrew51. Aflange521 provided at the bottom ofmember52 allows easy engagement of the assembly withinrails40 or any attachment means, that do not necessarily provide sliding possibilities.
• When the set screw is loose, cooperating components allow pivoting movement of the rod and eventually a rotational movement of the latter along its own axis. When the screw is tightened, a compression stress is generated with theinner portion532 ofmember53 pressing againstadaptors54 and56 andinner portion524 ofmember52. A tight fit is therefore created into thecylinder body55. This mechanical stress avoids any relative movement of the components. Moreover, thebody55 is pressed against the spreader arm or rail or the like on which it is engaged, creating a locking effect. The articulation is then slidingly and pivotingly locked.
• FIGS. 4A to4C illustrate views of an example of an articulation member such as the one used in the embodiment ofFIG. 1, withreference80. The figures shows two elongated andopposite clamping members82, each one provided with aninner seat portion83 to cooperate with aball end61 onrod60, and anapexes84 for engagement ofset screw member81. An innerannular groove85 is also provided for engagement of thesecond positioning rod70. The85 is arranged in a direction substantially perpendicular with regard to the longitudinal axis of the clampingmembers82. Apreload spring62 ensures that themembers82 and61 are property maintained as an assembly. Moreover, the twomembers82 are tightened together withscrew member81.
• They provide a housing for ball end61 and a portion ofrod70. Depending on the tightening ofscrew member81, the articulation maintains therods60 and70 in a locked or mobile arrangement The angular movements ε and φ ofpositioning rod70 are achieved through relative movement ofmembers82 with respect to61.Screw member81 is preferably provided with an arrangement that gives the possibility to adjust the positioning by using either side ofscrew member81. This feature is advantageous because the working area W is in general very small and the access to a specific side of thescrew member81 is limited for the surgeon.
• FIGS. 4B and 4C illustrate such an arrangementLeft side knob801 extends longitudinally with threadedrod802 through theleft damping member82 and is screwed to the right damping member which is provided withinner thread806. The end portion ofrod802 and the corresponding inner portion ofknob801 are shaped with two oppositeflat surfaces803, allowing torque transmission from the knob to the rod. Lockingballs805 provided in a circular groove in the inner portion of right side knob and maintained with aset screw804 keep the components together. With such an arrangement, the surgeon tightens or untightens the two clampingmembers82 by actuating any of the twoknobs801. The rotational movement allowsinner threads806 to create a translational movement of correspondingright clamping member82, that will therefore get closer or farther from the other facing damping member, resulting in a tightening and loosing effect.
• With these various adjustment possibilities, the contacting means30 can easily be positioned very accurately with regard to the target arteria of the heart. Moreover, according to a variant, a coarse adjustment is performed with one articulation member (for instance the first articulation member50) and a fine a adjustment is achieved with the other articulation member (for instance the second articulation member80).
• FIG. 5A illustrates a second preferred embodiment according to the invention. The sternum retractor arrangement is similar to the previously described one. However, the positioning means20 slightly differs from the first embodiment According to this second embodiment, twoarticulation members150 and250 are provided. These articulations may be in many aspects similar to those described above.
• FIG. 5B is a perspective view, partly cut away, illustrating thearticulation members150 and250, and thefirst positioning rod60. One articulation member is arranged to allow a sliding movement of the positioning rod through it. Aninner rod member151 is provided with atransversal hole152 seated in a hollowcylindrical body153, with two open ends156. Atreaded portion155 extends upwardly beyond the body for engagement with aset screw51. The bottom portion extends downwardly beyond the body and is provided with aflange154 for engagement with rails40.
• When setscrew51 is tightened, a tensile strain causes the bottom edge of thecylinder body153 to press against the edge ofwindows156 through whichrod60 extends. The same strain causes the bottom edge of thecylinder body153 and the upper edge offlange154 to press against therails40 in opposite directions. The assembly is therefore locked. When set screw is loose, no strain acts against the components. The rod can slide through the articulation and the articulation is capable of sliding and/or pivoting along the rails. Theopposite articulation member250 can be similar to the one described above or can be simplified by havingrod60 in a fixed configuration on relative toarticulation member250. This can be achieved with an assembly comprising aninner rod member151 and acylinder body153 similar to those previously described. The rod is then attached to the cylinder body. This allows sliding and/or pivoting movement of thearticulation member250 along therail40. One or both articulations can be displaced along the rails or placed on discrete locations on the retractor, if no rails are provided.
• The articulations can be set in a symmetric disposition, with each articulation having an identical position with respect to the rack bar. They can also be arranged in asymetrical disposition on the same arm, etc., as shown inFIG. 13. The translational motion of therod60 through thearticulation150 remains an advantageous feature of this embodiment. For example, if during surgery, the sternum retractor opening must be modified, therod60 can slide through one of the articulations (for instance, the articulation engaged in the movable spreader arm), allowing thesecond positioning rod70 and the contacting means30 to remain in substantially the same position with regard to the heart. This allows efficient readjustment of the surgical apparatus without complete disassembly of the positioning means.
• Of course, with such an embodiment, thesecond articulation member80 is slightly different from the one described above (shown inFIG. 2). This second articulation member allows advantageously five types of displacements: first, an axial sliding motion R3 to allow the positioning of thesecond rod70 along the centerline axis ofrod60; second, an axial sliding motion R4 to allow the positioning of thesecond rod70 througharticulation member80; third, an angular rotation of the contacting means30 about therod70 axis; fourth, in the plane defined by the axes of therods60 and70, angular orientation of said rods; fifth, angular rotation ofrod70 around the axis ofrod60. Theset screw81 allows for easy setting and readjustment ofrod70 with respect torod60. The contacting means30 is provided at the end portion of therod70, within the working volume W. Therails40 can eventually be extended with a separate rail portion placed on the rack bar.
• FIG. 6 illusbtres a transversal view of this embodiment. From this drawing, it can be seen that the contactingmeans30 has a very specific shape. In this particular embodiment, the slightly curved profile allows the positioning of the contacting means with regard to the heart, so that the heart is placed in the concave side of the contacting means. With such an arrangement, the positioning means is capable of producing a pulling force against the heart. These features will be described thoroughly herein below.
• FIG. 7 shows a variant of the previous embodiment. According to this variant, therod60 is bent to form a U-shape with regard to the two articulation members. Such a shape gives additional adjustment possibilities to position the contacting means with regard to the heart.
• FIG. 8 illustrates a further variant of the embodiment illustrated inFIG. 5A. According to this variant, therod60 is shaped in the form of a circular arc. The letter “R” on the figure illustrates the radius of the corresponding virtual circle. Once again, this particular shape allows a very accurate positioning of the contacting means with regard to the target artery.
• FIG. 9 illustrates a top view of a variant whereas one or bothblades7 are rotatably mounted on the retractor arms. The remaining features being similar to those already described are not illustrated. This variant is advantageous while it gives a possibility to adapt the blade arrangement to the sternum of the patient to be treated, without affecting the remaining components of the apparatus. For example, one blade could be installed slightly rotated with regard to the other one.
• According to the invention, the surgical apparatus advantageously provides anchoring means disposed in discrete positions along thearms3 and4 or possibly at any other location on the device.FIGS. 10A through F illustrate different variants of such anchoring means. These anchoring means serve many purposes, for example to attach “in-process” sutures that are strategically used to position tissue or organs away from primary surgical operation; to attach Silastic™ rubber bands, or silicon loops, utilized during myocardial mobilization, or pericardial traction; to attach sutures or silicon rubber loops, serving to “brace” the positioning means rod in significantly overhung orientations with respect to the retractor; and to secure any peripheral equipment used during operation to keep uncluttered chest cavity during surgery. These anchoring means are intended to allow a quick assembly and disassembly of the wire, suture, Silastic™ rubber bands, etc.
• FIG. 10A shows an example of an arrangement with such means preferably disposed along a rail.FIG. 10B illustrates an example of an anchoring means with a “V” shaped aperture in which the wire can be inserted very quickly. At the base of the “V”, a slightly enlarged opening provides a seat to lock the wire. Each side of the “V” shape is provided with a blade, retaining the wire that is wounded-up around the body of the means.
• FIG. 10C illustrates a different shape of anchoring means with a nail like head.FIG. 10D illustrates another variant which is shaped like an inclined rod.FIG. 10E illustrates anchoring means consisting of T-shape apertures provided in the spreader arm or in any other location of the surgical apparatus.FIG. 10F illustrates a pin type anchoring means. As illustrated the pin is advantageously slidingly arranged.
• FIG. 11 illustrates a third embodiment of a heart stabilizer according to the invention. This simplified embodiment uses a standard sternum retractor. The positioning means20 are connected to the sternum retractor through anarticulation member250 attachable to the rack bar of the retractor. According to the embodiment illustrated inFIG. 11, the articulation member consists of a “U” shaped sliding member, laterally inserted into therack bar2. Aset screw251 allows to lock or unlock the articulation member on the rack bar. The unlocked position allows the surgeon to slide the assembly on either side of the bar. It also permits him to slide thefirst positioning rod60 axially. It also allows him to slidingly and pivotingly setrod60 with respect to rackbar2 througharticulation member250. Theset screw251 allows an easy longitudinally positioning of the assembly.
• The axial positioning can be set either with the articulation member throughset screw251 or with thesecond articulation member180 through aset screw181, though this second articulation member mainly serves to angularly position asecond positioning rod70. This angular position can be easily modified as the two clamps are pivotally connected together. The contactingmember30 is provided at the ending portion of this rod located within the working volume W.
• The characteristics related to the rods and second articulation member are similar to the second embodiment illustrated inFIG. 5A and described above. This very simple attachment means allows the use of a heart stabilizer according to the invention with an existing sternum retractor. Such a “retro-fit” is very advantageous while mast hospitals or clinics are already equipped with retractors. This existing equipment can thus be updated. This embodiment can also feature quick connect/disconnect articulations, as described below.
• FIGS.12 to15 illustrate a further embodiment particularity suited to retrofit applications but not exclusively reserved for them. A knowntype sternum retractor1 may be used. According to the invention, the retractor is easily modified to provide attachment means, such as for example attachment holes8 preferably located by each end portion of the spreader arms and/or arranged in discrete locations along the retractor.
• Different types of stabilizer can then be used to complete the arrangement. For example, a stabilizer with positioning means such as described above for the embodiments ofFIG. 1A or5A The attachment means could serve to attach rails, that for example are similar to those of FIGS.1 or5, or an assembly without rails, the articulation member being attachable to any of the retractor holes8.
• FIGS. 14, 15, and16 illustrate examples ofattachment100 to theretractor1.FIG. 14 shows an example with two supports onto which the rail is attached. The rail could be of a rod type, as shown inFIG. 14, or sliding type as shown inFIG. 1A, or any other appropriate type.FIG. 15A illustrates an example of a support provided with arubber boot101, arod102, and a locking system actuated by a cam-lock. The system is illustrated in the locked mode, in which the rubber expansion fills the surrounding cavity creating thus a locking effect.
• FIG. 15B illustrates a magnetic type of support which offers the advantage to avoid the holes on the retractor in the previous examples. The holes are replaced by amagnetic insert111, on which the magnetic support can be placed. Themagnetic support110 preferably comprises a layer arrangement with alternate layers of magnetic112 and nonmagnetic113 alloy. A portion of the layer assembly is transversally movable with regard to the remaining portion.Buttons114 allow the surgeon or user to set the assembly onto the retractor by placing the two portions in magnetized or unmagnetized positions.
• FIG. 15C illustrates a threaded type support which can easily be set using conventional tooling.FIG. 15D illustrates a spring loaded ball bearing type support adjustable in a locked or unlocked position depending on the lateral position of the balls. The figure illustrates the locked mode, in which the balls are projected and maintained in a locking arrangement by cooperating with a grooved portion of the retractor. In the unlocked position, the groove is free and the support can be removed.FIG. 15E illustrates a hydraulic deployment arrangement. A set screw acts on a piston arrangement which can cause a lateral flexible membrane expansion or retraction under the effect of an inner oil pressure increase or decrease respectively.FIG. 15F illustrates a mechanical wedge type support.
• The above variants are only examples of attachment means that could be provided. Other types of variants may be used, without departing from the spirit of the invention.
• According to the invention, the positioning means could be positioned at least in six different orientations with respect to the sternum retractor, and consequently the patient's heart (seeFIGS. 13A to13E illustrating examples of rail configuration): four orientations along the perimeter of the retracted chest cavity, and two cross-corner diagonal orientations. This maximizes the options for optimum accessibility to the target artery. Of course, according to the respective longitudinal position of the articulations along the arms, a plurality of other positions is also possible. Furthermore, if two rails are used, the possibilities will still be increased.
• FIG. 16 shows a variant with easy to connect/disconnect positioning means. Such a variant could be used with any embodiment, with or without rails. Aresilient clip assembly300 of known type could be provided. Such an arrangement enables the surgeon to place the contacting means with more flexibility and allows an easier access to the working volume, which is in general a small volume, difficult to access as many complex instruments obstruct the cavity. This embodiment allows easy access without having to proceed to many adjustments; these adjustments are advantageously performed after the contacting means are well placed. The figure also illustrates an example of rod type rails on which an annular articulation can be slidingly placed. The quick assembly/disassembly function can also be achieved via variety of interfaces (cam-type locking devices, toggle devices, screw type devices, mechanical magnets, etc.).
• FIG. 17 shows a variant in which the positioning means, and namely the articulation member, are attached to the sternum rector via a slot provided on the rack bar. Such a slot can be realized on an existing retractor, resulting in a retrofit arrangement. It can also be provided on a retractor specifically as per the invention.
• FIGS. 18A to18C illustrate a variant where thearticulation members650 are bent in such a way to place therod member60 laterally distant from thesternum retractor1. With such an arrangement, the working area is of easy access and with enhanced ergonomy.
• FIGS. 19 and 20 show variants of the embodiment previously described and illustrated inFIG. 1A. The articulation members and rods of the embodiment ofFIG. 1A are replaced by known-type arms capable of providing rotation, pivoting and translational motions or the like. These arms types are similar to those encountered in desk lamps. These variants are advantageously simple to manufacture, quick and easy to adjust Other variants offering similarities to these ones can also be provided, sometimes with less positioning capabilities, for example without rotation, without pivoting movement, etc.
• FIGS. 21A to21D illustrate variants of shapes for the positioning rods. Shapes in a straight line, curved, elbowed or double elbowed, etc. These are only examples of an almost unlimited type of shapes that can be used without departing from the spirit of the invention.
• FIGS. 22A and 22F illustrate examples of different shapes of rails that can be used to provide the sliding movement of the positioning means: rectangular, dovetail, etc. These are only examples of an almost unlimited type of shapes that can be used without departing from the spirit of the invention.
• FIGS. 23A and 23B illustrate the contactingmeans30 when placed against the heart surface. Two elongated contactingarms31 defining therebetween anarterial window32 are provided. The two arms are preferably substantially parallel and the slot defined by their inner edge is used as an arterial window. That is to say that the target artery TA will be aligned between these two arms when the contacting means is adequately placed. The arms are shaped to be capable to press against the heart surface HS immediately surrounding the target artery. In this way, the target artery becomes easily accessible for the surgery purpose. As a result, the heart stabilizer locally prevents the heart from moving around the target artery, allowing thus direct coronary bypass surgery on a beating heart In areas where the arteries are incrusted in the heart surface, the contacting arms provide a way to raise the target artery through the arterial window, thereby increasing access for the purpose of the surgery.
• This aspect of the invention can be clearly seen inFIG. 23B. The target artery TA is engaged between thearms31. The surgeon can thus advantageously attach the Silastic™ wire SL to the portions of the target artery that are upstream and downstream of the grafting site. This provides a very efficient way of restricting the blood flow. The surgeon can then cut the artery and realize the grafting process. Attachment means310 are preferably provided on the non-contacting surface side in order to set the Silastic™ wire in an optimum position. For example, slotted walls can be provided on the contactingarms31. These attachment means310 are spaced sufficiently apart on said contacting arms to allow the grafting process. These attachment means can eventually be adjustable, for example axially with regard to the arms and/or angularly.
• The angle of the attachment means310 with respect to thecontact arm31 can be determined to coincide with the angle of the Silastic™ wire with respect to said arm as it wraps around the target artery. Furthermore, the walls or the like are preferably capable of being oriented so that the wire penetrates in a substantially normal direction with regard to the walls plane, that is to say a preferred angle γ (seeFIG. 30A) between 25 and 80 degrees.
• FIGS. 30B to30G illustrate variants provided with attachment means310 of different profiles and shapes, respectively “slotted blade type”, “dip type”, “spring type”, “slotted hemisphere type”, “hanger type”, and “plate-like type”. These examples clearly illustrate that the Silastic™, silicone rubber, siliconized rubber, silicone elastomer or elastic wire (or other type of wire) can be attached by a plurality of attachment means types.
• In order to facilitate the surgery, it is preferable to first set the contacting means against the heart source in the required position to free the target artery and secondly to secure the contacting means and positioning means assembly to the sternum retractor. To remove the assembly, it is preferable to first disengage the contacting means from the positioning means, thereby easing the separation of the containing means from the heart surface and minimizing the risk of damage to the newly sutured bypass vessel. Otherwise, the positioning means could also be disengaged first form the retractor, to allow easy separation of the contacting means from the heart surface. In all embodiments, open ended articulation means and/or clamps for the second positioning and help achieve this quickly and effectively (seeFIG. 16).
• The profile characteristics of the contacting means are very important. For example, as shown inFIG. 23B, the ending portion of thearms31 is preferably curved. The arms are advantageously provided with a ski-like shape with the tip portion oriented to be away from the heart surface to prevent damage during involuntary contact, avoiding trauma to the heart surface.
• FIGS. 24 and 25 illustrate two “families” of contacting means. These families originate from the position of the contacting means with regard to the heart during the surgery and/or the type of force resulting from this position.FIG. 24 shows a “push type” arrangement, whereasFIG. 25 shows a “pull type” arrangement. From these figures, it can easily be seen that the positioning means plus contacting means assembly provides respectively a pushing force (see alsoFIGS. 23A and 23B) and a pulling force (see alsoFIG. 6). The “push type” and “pull type” are preferred for use with the anterior and posterior arteries respectively. In all embodiments, the motion degrees of freedom of the second articulation means provide the adaptability to cater for push and pull arrangements in a manner to maximize ergonomics of surgery (FIGS. 24 and 25).
• The contacting means profile is preferably adapted in function of these two families.FIGS. 26, 27 and28 show examples of “push type” profiles. The attachment means310 are then provided on the upper portion of thealms31. The illustrated example inFIG. 26 is advantageously of oval shape. This facilitates the access to certain arteries that would otherwise be difficult to read.
• Many other profiles are advantageously provided, each one of them matching with a specific area of the heartFIGS. 27 and 28 illustrate further examples with spoon-like profiles:FIG. 27 with standard spoon configuration (convex contact) andFIG. 28 with concave contact. Adapted profiles are pile for maximum surface coverage, thereby minimizing heart trauma. Moreover, the interface surface with the beating heart is optimized to maximize stability while minimizing risk of damage to the heart.
• FIGS. 29A and 29B show a variant of “pull type” arrangement, in which a given angle is provided between the positioning rod and the contacting means.
• FIGS. 31A to31F show variants of the contacting means with textured sits favoring adherence between thearms31 and the heart surface, to ensure minimum slip with regard to the heart tissue for example caused by the heart pulsation. Various types of textures can be provided, like for example, (fromFIGS. 31A to31F respectively) with grooves, with dimples/pedestals, with holes, with perimeter fence, with jagged outer contour, with covalently banded surface treatment, etc. This helps to prevent “skidding” or “slipping” on either side of target artery during grafting. The contacting means are provided to be in relation with the cardiac organs, in particular the heart The terms “cardiac organs” comprise the heart, but also the surrounding vessels and tissues, in particular the mediastinum, the pericardium, the thymus, the area between two lungs, etc.
• To simplify the surgeon's task and to free the cavity for better ergonomics, the positioning rods may also provide different features, like holes or grooves, or the like.
• FIG. 32 illustrates an example in which grooves and holes are used as anchoring points. Those features can also be used with Silastic™ wire, suturing wire, suturing silk, silicon loops or the like inserted through said holes and/or said grooves, and attached to anchoring me on the sternum rear to brace and noggin the assembly as rigidly as possible.
• The different parts and components of the present invention can be manufactured from either a biocompatible plastic, for example medical grade ABS, for single use, or in surgical stainless steel or any other biocompabble sterilizable material to allow for repeat usage.
• The above description of the preferred embodiments should not be interpreted in any limiting manner since variations and refinements are possible without departing from the spirit of the invention.

Claims (1)

1. A retractor assembly for retracting a surgical incision in a patient, said retractor assembly comprising:

a generally elongated guide member, said guide member having a guide member mounting rail extending along a length thereof;

a first spreader arm and a second spreader arm, said first and second spreader arms being mechanically coupled to said guide member; said first and second spreader arms being movable relative to each other along said guide member between a first position wherein said first and second spreader arms are in a generally adjacent relationship relative to each other and a second position wherein said first and second spreader arms are in a generally spaced apart relationship relative to each other;

a first retractor blade and a second retractor blade respectively extending from said first and second spreader arms, said first and second retractor blades respectively defining a first and a second blade contacting surface for respectively engaging opposed body tissue edges of said surgical incision during retraction thereof;

at least an arm section of said first or second spreader arms having a spreader arm mounting rail extending along a length thereof;

an instrument-positioning member operatively coupled to either one of said spreader arm mounting rails or guide member mounting rail, said instrument-positioning member being moveable between a loosened configuration and a locked configuration wherein respectively;

in said loosened configuration said instrument-positioning member is slidable along said mounting rail; and

in said locked configuration, said instrument-positioning member resists any movement relative to said mounting rail.

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