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[0001] The present invention relates to the field of surgical instruments and more specifically, to a surgical loop and procedure for partially or fully constricting an anatomic conduit, or displacing or restraining a body tissue.
[0002] During the course of a surgical procedure, it is often required to displace or restrain a body tissue. This tends to facilitate surgical access to the target anatomic tissue in need of the surgical intervention, which is contained in the displaced or restrained body tissue. Alternatively, a body tissue may be displaced or restrained away from the site of a surgical intervention in which the target anatomic tissue is situated.
[0003] During many types of surgical interventions, it is also often required to constrict or ligate, either partially or fully, an anatomic conduit in order to restrict or prevent flow through said anatomic conduit, during at least a duration of the surgical intervention. For instance, during a beating heart bypass surgery procedure, an anatomic conduit such as for example a target coronary artery may be ligated to temporarily restrict or arrest blood flow through an arteriotomy incision in said target artery, while the patient's heart continues to beat. This tends to achieve a substantially bloodless surgical field during a coronary artery anastomosis surgery performed on said target artery. Other anatomic conduits include such conduits as arteries, veins, organ ducts, air passageways, or other like anatomic conduits.
[0004] Constriction or ligation of an anatomic conduit may be achieved through a hemostat or other like surgical clamp. When fragile anatomic conduits are involved, such a method of constriction or ligation tends to be traumatic. If a surgical intervention is intended on an anatomic conduit, in a region of close proximity to the site of constriction or ligation, such a method tends to yield a non-ergonomic surgical site due to the space occupied by the hemostat, or other like surgical clamp.
[0005] A non-elastic surgical suture may also be used to encircle and subsequently constrict an anatomic conduit. Pulling the loose ends of the surgical suture induces a tension in the surgical suture and results in a compressive load applied to said conduit. As such, the desired amount of constriction or ligation of anatomic conduit is achieved. The non-elastic nature of a surgical suture, and its generally thin cross-section relative to the anatomic conduit, tends to induce trauma to the said conduit. Trauma may at times result from the snaring effect, or wire-cutting effect, especially when complete ligation of an anatomic conduit is desired. Surgical sutures are generally configured with a needle at one end thereof, to facilitate their insertion through a body tissue within which an anatomic conduit is found.
[0006] Elastic ligatures have also been employed to constrict or ligate, partially or fully, anatomic conduits. The elastic quality of these elastomeric surgical loops is desirable since a certain amount of yield is provided in such surgical loops when they are engaged with anatomic tissue and pulled with the aim of ligating. As such, unlike non-elastic surgical sutures, the amount of pressure applied to an anatomic tissue, or the compression by which an anatomic conduit is constricted, tends to be more controlled. Moreover, relative to non-elastic sutures, elastomeric surgical loops will yield a certain amount if an anatomic tissue is inadvertently displaced during a surgical procedure, or will yield a certain amount if an anatomic tissue is moving or pulsating due to a physiologic function. As such, relative to non-elastic surgical sutures, there is a lower likelihood of inducing trauma to the anatomic tissue.
[0007] In certain surgeries, substantially flat elastic ligatures with solid cross section have also been employed. However, these elastic ligatures tend to dig into a body tissue or anatomic conduit if they become twisted during their deployment. This may lead to unwanted tissue trauma.
[0008] Hollow elastic surgical loops or ligatures have also been developed. With respect to solid elastic surgical loops, a hollow configuration tends to enhance the yielding potential of a surgical loop when said loop is engaged with anatomic tissue and pulled with the aim of ligating. This enhanced yielding potential tends to be accomplished without reducing the contact width of the surgical loop when it is engaged with an anatomic conduit.
[0009] Hollow elastic loops with sealed ends have also been developed with the aim of reducing the likelihood of a surgical loop twisting during its engagement and deployment with anatomic tissue. Since the ends of these hollow elastic loops are sealed to entrap air therein, collapsing of the surgical loop tends to be resisted when it is placed in contact with anatomic tissue. As such, the interior surface of the surgical loop does not easily come into contact with itself, thereby tending to reduce the likelihood of twisting said surgical loop during its deployment. Instead, this entrapped air cavity tends to facilitate the rolling of a surgical loop about its longitudinal axis as it engages with anatomic tissue. One such elastic hollow surgical loop with sealed ends is available from Quest Medical, Inc. of Allen, Tex., under brand name “Retract-O-Tape™”. The Retract-O-Tape surgical loop, or vascular loop, is configured with a needle at one end thereof to facilitate its insertion through a body tissue.
[0010] The retraction of an anatomic tissue, or the constriction of a vessel contained within an anatomic tissue, is accomplished by piercing the anatomic tissue with the needle at the end of a surgical loop or suture, threading a length of surgical loop or suture through the pierced tissue, and pulling simultaneously on both resulting lengths of surgical loop or suture; that is, the length between the pierced tissue and the free end of the surgical loop or suture, and the length between the pierced tissue and the needle-bearing end of the surgical loop or suture. Once a vessel is encircled with a surgical loop or suture, pulling the two resulting lengths in a generally opposed direction induces a compressive load on the vessel contained therein. Desired vessel constriction or ligation is achieved by maintaining the tension on each of the two free lengths of the surgical loop or suture through a variety of methods. In one method, the free lengths may be held under tension by a surgical assistant. This method represents an inefficient use of the surgical assistant's time and tends to be cumbersome and non-ergonomic for the surgeon. In another method, each of the free lengths of a surgical loop may be secured to a surgical retractor, to a surgical drape, or to another part of the patient's anatomy with a surgical clamp or other like means. This tends to compromise the ergonomics of the surgical window, and the surgeon's access thereto. The situation is further aggravated when multiple surgical loops or sutures need to be secured in this manner to achieve the desired anatomic tissue retraction or vessel constriction.
[0011] Recently, with the advent of less-invasive cardiac surgery, surgical loops have been utilized to constrict or ligate coronary arteries during the course of such surgeries. For instance, in coronary artery bypass graft (CABG) surgery performed directly on a beating heart without cardio-pulmonary assistance, elastic surgical loops may be used during at least a duration of the surgical procedure to constrict or ligate a target coronary artery requiring a bypass graft. A surgical loop is generally placed around a target coronary artery, at a location upstream of the intended arteriotomy and subsequent anastomosis, thereby serving to restrict blood flow through said target artery. Another such surgical loop may be placed at a location downstream of said arteriotomy incision, tending to minimize backflow from collateral arteries. As a result, an arteriotomy and subsequent anastomosis may be performed on said target artery in a substantially bloodless surgical field while the patient's heart continues to beat.
[0012] Surgical loops may be secured in a manner as described above or may also be secured to a coronary artery stabilizer utilized to locally immobilize a portion of the beating heart surface, in the vicinity of the target coronary artery. One such coronary artery stabilizer and method of securing a surgical loop thereto is described in International Application No. PCT/CA98/00821 by Cartier and Paolitto filed Aug. 27, 1998 and entitled “Sternum Retractor for Stabilizing the Beating Heart During Coronary Artery Bypass Graft Surgery”. Although, different types of coronary stabilizers exist, they tend to generally contact the surface of a beating heart with a substantially planar tissue-contact surface. Such tissue-contact surfaces are typically interrupted to define an arterial window serving to expose a target artery therebetween. For instance, in one example, the coronary stabilizer may have a substantially u-shaped contact surface. In another example, the coronary stabilizer may be comprised of two, or more, mating and demountable parts which form a substantially rectangular contact surface within which is disposed a substantially rectangular arterial window. In some types of coronary stabilizers, a surgical loop may be secured to said stabilizer through a feature such as a slotted attachment fitting, or other like means. Such attachment fittings generally protrude above the tissue-contact surface of the coronary stabilizer, and as such, a surgical loop is generally secured to said stabilizer in a location situated in height above the tissue-contact surface of said stabilizer. Encircling of the target artery with a surgical loop, and subsequently pulling and securing the ends of said surgical loop while applying a compressive force on the target artery, will tend to at least partially constrict the target artery, but also will tend to extrude through the arterial window, the portion of the myocardium tissue containing the encircled target artery. Generally in this configuration, the greater the extrusion of the myocardium through the arterial window, the greater the magnitude of the resulting constriction of the target artery contained substantially therein. In certain instances, this may lead to trauma of the coronary artery by virtue of extensive external snaring.
[0013] In a sense, encircling of an anatomic conduit with a surgical loop and subsequently pulling in a generally opposed direction, on each of the two resulting lengths of said surgical loop, applies a tourniquet effect to said conduit. In order to obtain a substantially 360 degree tourniquet, the surgical loop forms a helical winding around said conduit. As such, a shearing load is applied to the anatomic conduit by virtue of this helical winding, and by virtue of pulling on each of the two resulting lengths of surgical loop at different locations along the longitudinal axis of said conduit. This shearing action may induce a trauma to the anatomic conduit as it may cause it to twist and assume a tortuous configuration. This is especially prevalent with smaller diameter anatomic conduits, whose size approach the external cross-sectional dimension of the surgical loop.
[0014] According to a first aspect, the present invention provides a surgical attachment device, such as a surgical loop, comprising:
[0015] an elongated wire-like member extending between a first end and a second end and having a cross-section profile adapted to vary between a free state cross-section profile and a constrained state cross-section profile;
[0016] a holding member engaged with a first portion of said wire-like member, and provided with a clamping member capable of holding a second portion of said wire-like member between at least two wire contact portions;
[0017] said wire contact portions movable, one with respect to the other, between a substantially closed configuration and an open configuration whereby at least one of said wire contact portions is resiliently biased towards said substantially closed configuration.
[0018] Such a device is of relatively simple construction, reliable and particularly easy to use. The normal position being advantageously with the wire contact portions in their closed configuration, the wire-like member remains engaged with holding member without any specific manipulation. The wire contact portions are placed in their open configuration only when the clamping member is actuated. This tends to facilitates repositioning of the engaged portion of wire-like member through the clamping member. Moreover, the risk of accidental detachment of the wire-like member from the holding member tends to be reduced since in the normal (or at rest) configuration, the wire contact portions are resiliently biased towards the substantially closed position.
[0019] Advantageously, in said substantially closed configuration, a portion of said wire-like member placed between said wire contact portions is substantially at said constrained state cross-section profile.
[0020] This closed configuration is generally utilised to hold or engage the second portion of the wire-like member, for instance once a surgical loop is disposed around a body tissue, or an anatomic conduit such as for example a coronary artery, or the like.
[0021] Advantageously, in said open configuration, a portion of said wire-like member placed between said wire contact portions is substantially at said free-state cross-sectional profile.
[0022] This open configuration is preferred during the placement or adjustment of the wire-like member with respect to the clamping member.
[0023] The holding member is advantageously further provided with an actuator adapted to move at least one of said wire contact portions of said clamping member from said substantially closed configuration to said open configuration when activated. This actuator is preferably provided with a deformable portion of said holding member.
[0024] A simple type of actuator is provided. Eventhough the holding member has an increased number of functional features, the number of components is kept to a minimum. The surgeon may advantageously actuate the actuator with one hand, and with the other hand place or insert a portion of wire-like member into the clamping member, or readjust the position of wire-like member within the clamping member, thus avoiding the intervention of a surgical assistant. The resiliently biased wire-contact portions automatically engage, clamp or hold the wire-like member inseerted therein as the actuator is released. This effect may also be progressively provided, for instance by gradually depressing or releasing the actuator.
[0025] The holding member is advantageously unitary. A single component holding member tends to simplify construction, and facilitate operation in use. Furthermore, fewer components minimizes the likelihood of forgotten components in a patient's body after a surgical intervention is performed.
[0026] The clamping member is advantageously provided with a resilient hinge connecting said wire contact portions and disposed between said clamping member and said actuator.
[0027] In a preferred example, the wire contact portions are provided at a free end of said holding member. In a further example, the wire contact portions are provided at a substantially central portion of said-holding member, said actuator being provided at a free end thereof.
[0028] In a still further example, the surgical attachment device advantageously comprises a pair of substantially symmetrically arranged clamping members, each extending from a common hinge and each providing an actuator for the other. Such a toggle-like arrangement may provide more versatility or functionality in certain surgical interventions. It is of a simple construction and easy to use, while remaining compact.
[0029] At least one of the wire contact portions of said clamping member may advantageously cooperate with a spring-like member. The spring-like component is preferably an internally disposed or encapsulated component within the holding member, for instance covered with a polymer material or a surgery-approved material preferably similar to that of holding member. Such a construction avoids the possibility that an additional component could be damaged or lost during the surgery. The spring-like member also advantageously provides improved resiliency and is particularly resistant to cycles.
[0030] A surgical loop may be advantageously provided with a needle affixed to one end of said wire-like member. As such, this allows tubular body to be inserted through a body tissue.
[0031] A surgical loop may be advantageously provided with an enlarged ending portion configured at one end of said wire-like member. For instance, this end may be a bulb-like enlargement. In an example wherein both ends are enlarged, the holding member is thus trapped from becoming disengaged from wire-like member. The needle may also be used for this purpose. As such, an integral assembly comprising a tubular body and holding member is provided.
[0032] The wire-like member advantageously has a hollow substantially central portion. It is preferably made of elastomeric material.
[0033] In a further aspect, the invention provides a holding member for use with a surgical attachment device according to the present invention.
[0034] The invention also provides a surgical attachment device, such as a surgical loop, comprising:
[0035] an elongated wire-like member extending between a first end and a second end and having a cross-section profile adapted to vary between a free state cross-section profile and a constrained state cross-section profile;
[0036] a holding member engaged with a first portion of said wire-like member, and provided with a clamping member capable of holding a second portion of said wire-like member, said engagement with said first portion of wire-like member being provided by at least one attaching member, adapted to simultaneously provide:
[0037] a sliding engagement of said wire-like member through said attaching member; and
[0038] a restraining force acting on said wire-like member to cause said cross-section profile of said wire-like member to be altered to said constrained state cross-section profile on at least a portion of wire-like member that is in engagement with said attaching member.
[0039] The resulting engagement is of particular interest because it enables the wire-like member and the holding member to slide relative to one another when the restraining force applied by the attaching member to the engaged portion of wire-like member is overcome. The resulting friction between said attaching member and engaged portion of tubular member may advantageously be modified by varying the cross-section profile or area of the wire-like member. For instance, if the wire-like member is submitted to a tension force along its longitudinal axis, due to its elastic properties its cross-sectional area is reduced along with the cross-section profile, thus resulting in reduced friction. As such, the holding member may be positioned relatively easily along the wire-like member. Without said tension force (tubular body at rest), the tubular body resumes its free-state cross-section profile, except in the region of the engaged portion of the wire-like member with the holding member, where the attaching member provides a restraining force and the wire-like member assumes a constrained state cross-section profile and/or area. As such, a friction force between the holding member and engaged portion of wire-like member results. In this latter state, with the engaged portion of wire-like member in constrained state, the holding member is substantially held or retained but may also slide along wire-like member if a sufficient load is applied to the holding member, one that will overcome the friction force between the holding member and engaged portion of wire-like member. The resulting friction force, and ease with which holding member may slide along wire-like member, may be adjusted to a preferred level by selecting the appropriate interface dimensions, materials, and other mechanical parameters for the holding member and wire-like member. According to the present invention, a modification in the cross-sectional area also corresponds to a variation of the cross-section profile. A variation in cross-section profile, however, may or may not correspond to a change in cross-sectional area.
[0040] The invention further provides a surgical attachment device, such as a surgical loop, comprising:
[0041] an elongated wire-like member extending between a first end and a second end, each end being provided with an abutment member;
[0042] a holding member, slidingly engaged with said wire-like member, and movable between said abutment members;
[0043] said holding member being provided with a clamping member capable of holding a portion of said wire-like member.
[0044] Such a surgical attachment device provides a surgical loop in which the holding member is safely maintained between the two ends of the wire-like member.
[0045] According to a further aspect, the invention further provides a holding member for a surgical attachment device comprising an elongated wire-like member, said holding member being provided with a clamping member capable of holding a portion of said wire-like member between at least two wire contact portions movable, one with respect to the other, between a substantially closed configuration and an open configuration whereby at least one of said wire contact portions is resiliently biased towards said substantially closed configuration.
[0046] Such a holding member is preferably used with a surgical attachment device such as a surgical loop, to provide a simple way of constricting or ligating an anatomic conduit and eventually readjusting said constriction or ligation during a surgery such as cardiac surgery. The holding member is preferably provided with an actuator adapted to move at least one of said wire contact portions of said clamping member from said substantially closed configuration to said open configuration when activated.
[0047] The different aspects of the invention also provide the following advantages.
[0048] The invention provides a surgical loop with a wire-like member and holding member or cooperating pledget that tends to achieve the constriction of an anatomic conduit, or anatomic tissue, through the securement of said wire-like member within said holding member or pledget. It is also advantageous that the holding member is produced as a unitary component as opposed to an assembly of components.
[0049] The holding member or pledget, and more particularly the clamping member, is adapted to be frictionally engaged with the wire-like member of a surgical loop. This tends to allow the pledget to be securely and releasably held in a desired location along the length of a surgical loop, without having to tie the pledget to the surgical loop, without having to wind the surgical loop around the pledget, or without having to glue or permanently affix the pledget to the surgical loop in a fixed position.
[0050] According to the different aspects of the invention, the amount of constriction applied to the anatomic conduit by the cooperation of a wire-like member and pledget may be easily readjusted without having to completely disengage an engaged portion of the wire-like member from its pledget and having to subsequently re-engage another portion of the wire-like member with said pledget.
[0051] Moreover, when surgical loop is used in conjunction with a coronary stabilizer used to perform surgery on a patient's heart, the invention further provides a surgical apparatus that tends to enable and maintain a desired magnitude of target artery constriction or ligation independently of the amount of extrusion of myocardium tissue within which is contained the said target artery.
[0052] The invention also provides a surgical attachment device that is able to constrict or ligate an anatomic conduit in a manner that tends to minimize the shearing action produced when an anatomic conduit is encircled with a traditional wire as previously described, thereby also tending to reduce the twisting of said conduit along its longitudinal axis.
[0053] The invention, in its several aspects, further provides a surgical loop with a wire-like member and cooperating pledget that tends to accomplish a partial constriction or full ligation of an anatomical conduit, without having to secure at least a portion of the surgical loop to a surgical retractor or other like, substantially-stable surgical support.
[0054] It also provides a surgical loop with cooperating pledget that tends to allow the readjustment of the amount of constriction or ligation of an anatomic conduit without having to completely disengage an engaged portion of wire-like member from its cooperating pledget and without having to subsequently re-engage another portion of the wire-like member with said pledget.
[0055] The invention further provides a surgical loop that tends to accomplish a partial constriction or full ligation of an anatomic conduit without inducing a twist or tortuosity to said anatomic conduit.
[0056] Finally, the present invention provides a surgical apparatus comprised of a coronary stabilizer and surgical loop with cooperating pledget that tends to maintain a desired target coronary artery constriction or ligation independently of the amount of target artery extrusion through an arterial window disposed in said coronary stabilizer.
[0057] These and other advantages of the present invention will become apparent from the description of the present invention and its preferred embodiments which follows.
[0058] For better understanding of the present invention and to show more clearly how it may be carried into effect, reference will now be made by way of illustration and not of limitation to the accompanying drawings, which show an apparatus according to the preferred embodiments of the present invention, and in which:
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[0082] The features and principles of this invention can be applied, in whole or in part, to cardiac surgery, vascular surgery, or other types of surgery requiring the partial or complete constriction or ligation of an anatomic conduit, or other body tissue. The description of some of the embodiments that follow will however be illustrated in the context of cardiac surgery, and more specifically to the partial or complete constriction of a target coronary artery during beating heart bypass surgery.
[0083] In part, the embodiments of this invention may advantageously be applied, if desired, to the coronary artery stabilizer described in International Application No. PCT/CA98/00821 filed Aug. 27, 1998 in the names of Cartier and Paolitto and entitled “Sternum Retractor for Stabilizing the Beating Heart During Coronary Artery Bypass Graft Surgery”, the contents of which is incorporated herein by reference. Alternatively, the embodiments of the present invention may also be applied, if desired, to other types of coronary stabilizers which are provided with a means of securing a surgical loop.
[0084] By way of a general overview and with reference to
[0085] Tubular body
[0086] Lumen
[0087] Tubular body
[0088] The opposite end of tubular body
[0089] As mentioned, needle
[0090] Tubular body
[0091] Tubular body
[0092] In this first embodiment (shown in
[0093] Referring to
[0094] Other variants in configuration of attaching member or substantially closed-perimeter openings are also possible. For example, an opening with a tri-lobe cam profile, a triangular opening, a rectangular opening, or any other like opening may also be configured in pledget
[0095] Closed-perimeter openings, like opening
[0096] Referring again to
[0097] If tubular body
[0098] To insert a portion of tubular body
[0099] Bias
[0100] Alternatively, slot
[0101] Generally, after a length of tubular body
[0102] Referring to
[0103] Pledget
[0104] Handle
[0105] In a variant of this first embodiment (
[0106] In another variant of this first embodiment, at least a portion of slot
[0107] With reference to
[0108] Pledget
[0109] Beam-type bias
[0110] Pledget
[0111] With reference to
[0112] Pledget
[0113] To deform slot
[0114] With reference to
[0115] Pledget
[0116] In this fourth embodiment, portion
[0117]
[0118] Referring now to
[0119] Referring now to
[0120] Surgery performed on an anatomic conduit may at times require the use of a surgical tool, that in a sense, may also serve as an anchoring platform to substantially secure a surgical wire, during at least a part of a surgical intervention. Anchoring platforms may exist in many varieties, shapes, and sizes depending generally on their function during a surgical intervention. One variety of anchoring platform is a body tissue stabilizer. One type of tissue stabilizer, commonly referred to as a coronary artery stabilizer, may be employed to locally immobilize a portion of a patient's beating heart surface, or myocardium, in order to facilitate a surgical intervention on a coronary artery thereof, while the rest of the patient's myocardium continues to beat.
[0121] Referring now to
[0122] Hand
[0123] Yoke
[0124] As illustrated, an array of surgical wire attachment fittings, in the nature of upstanding posts