Patent Grant
11058478
All publications, patent applications, and patents mentioned in this specification are herein incorporated by reference to the same extent as if each such individual publication or patent application were specifically and individually indicated to be so incorporated by reference.
The disclosed technology relates to systems and methods for electrosurgery. More particularly, the technology relates to an electrosurgical device appropriate for laparoscopic surgery through a trocar with a 5 mm port.
Biopolar electrosurgical instruments apply radiofrequency (RF) energy to a surgical site to cut, ablate, or coagulate tissue. A particular application of these electrosurgical effects is to seal blood vessels or tissue sheets. A typical instrument takes the form of a set of forceps or pair of jaws, with one or more electrodes on each jaw tip. In an electrosurgical procedure, the electrodes are placed in close proximity to each other as the jaws are closed on a target site such that the path of alternating current between the two electrodes passes through tissue within the target site. The mechanical force exerted by the jaws and the electrical current combine to create the desired surgical effect. By controlling the level of mechanical and electrical parameters, such as the pressure applied by the jaws, the gap distance between electrodes, and the voltage, current, frequency, and duration of the electrosurgical energy applied to the tissue, the surgeon can coagulate, cauterize, or seal tissue toward a therapeutic end.
Electrosurgical procedures can be performed in an open environment, through conventional incisions, or they may be performed laparoscopically, through small incisions, typically 0.5 cm-1.5 cm in length. A laparoscopic procedure may include the use of a telescopic rod lens system that is connected to a video camera and to a fiber optic cable system that conveys light to illuminate the operative field. A laparoscope is typically inserted into a port in the body through a 5 mm or 10 mm cannula or trocar to view the operative field. Surgery is performed during a laparoscopic procedure with any of various tools that are typically arranged at the distal end of a shaft and are operable by manipulation of a handle or an actuator positioned at the proximal end of the shaft, and are dimensioned such that they can pass through a port provided by the 5 mm or 10 mm cannula.
As electrosurgical tools are applied in laparoscopic procedures, challenges to the devices arise regarding dimensional constraints imposed by the operating environment, including the smallness of a typical port of entry, which includes the use of conventional trocars with a 5 mm inner diameter. The technology provided herein addresses the need for improvements in device technology, that permit downsizing of the device while maintaining appropriate levels of mechanical strength and electrosurgical capability. For example, it is generally desirable to extend the length of conventional forceps in order to allow the sealing of greater lengths of tissue. As forceps length increases, it becomes a challenge to exert an appropriate level of force, particularly from the distal end of the forceps. The present disclosure provides technologies that represent progress in addressing these challenges.
Embodiments of the technology relate to an electrosurgical device that is particularly suitable for laparoscopic procedures in that its distal insertable portion, including a shaft and an end effector, may have a diameter no wider than about 5 mm. This 5 mm insertable profile allows insertion of the device through a conventional 5 mm trocar. Commercially available trocars that are conventionally referred to as being “5 mm” generally have an internal diameter specification commonly expressed in inch units, and actually vary in range between about 0.230 inch and about 0.260 inch, even though 5 mm actually is the equivalent of 0.197 inches. In the present disclosure, therefore, “5 mm” or “about 5 mm”, when referring to the insertable profile of the device, or to the diameter of the shaft or the jaws in a closed configuration, refers to a diameter that is accommodated by presently available “5 mm” trocars. More particularly, embodiments of the shaft and closed jaws disclosed herein typically have a diameter in the range of about 0.215 inch to about 0.222 inch.
Embodiments of the electrosurgical device have an end effector such as a set of two opposing jaws or forceps that include one or more bipolar electrode pairs disposed on tissue engaging surfaces of the jaws, the device being adapted to effect tissue sealing and cutting. In some embodiments, the device includes a single bipolar electrode pair, one electrode in each of the jaws. In these embodiments, the electrodes are typically powered by a generator operating with a single radiofrequency channel. Other embodiments of the device may include a plurality of bipolar electrode pairs, and an operation by way of a plurality of radiofrequency channels. Some particular embodiments of the technology may take the form of non-electrical surgical device whose operation takes advantage of the mechanical and dimensional aspects of the technology.
Embodiments of electrosurgical device may have jaws that self align with respect to their longitudinal axes when the jaws are approaching closure. Self-alignment, as used herein, may further be understood to include lateral alignment, such that when longitudinally aligned jaws converge on closure, they meet opposingly, their lateral or tissue engaging faces meeting each other fully, from respective proximal end to distal end. The mutual alignment of the jaws can be particularly challenged when the jaws are closing around a piece of tissue, whose presence can urge the jaws to skew laterally out of alignment such that they do not meet opposingly. Accordingly, in these jaw set embodiments, the tissue-engaging surfaces of each of the opposing jaws, respectively, have mutually complementary longitudinally oriented self-aligning features that are sufficiently robust to be effective when there is a surgically appropriate amount of target tissue within the space between the closing jaws. Aspects and details of embodiments of self-alignable jaws are described further below.
Embodiments of the jaws may be rotatable with respect to each other by way of a pinless rotation mechanism that operates by way of rotatably cooperative features of the jaws that connect the jaws together. The pinless rotatable mechanism, in addition to securing the jaws together, allows the jaws to pivot between the open position and the closed position. Embodiments of the jaw set may pivot as a whole between an open and a closed position by virtue of one jaw pivoting with respect to a shaft while the other jaw remains fixed with respect to the shaft. The center of rotation of this pinless rotation system is not necessarily disposed at a position on a line corresponding to a central longitudinal axis of the shaft. Particular embodiments of the pinless rotation mechanism are displaced from that line. An advantage of this pivotal or rotational mechanism is that force that is transferred to the mechanism from an actuator wire is increased by the angular moment provided by the distance of displacement of the center of rotation from the longitudinal axis of the shaft, or more particularly by the distance between the axis of the actuator wire within the shaft and the center of rotation.
In some embodiments, the rotatably cooperative features of the pinless rotation mechanism of the jaws include a first jaw in which a proximal aspect of the jaw has a first arcuate track, and second jaw in which a proximal aspect has a second arcuate track, the first and second arcuate tracks being mutually complementary and slidably engageable with each other. In one arrangement of these rotatable components, the arcuate track aspect of first jaw is generally external or female with respect to the arcuate aspect of the second jaw. Thus, the track of the first jaw accommodates and generally encloses the track portion of the second jaw, and the second jaw is rotatable within the space provided by the first jaw. The complementary rotatable portions of the first and second jaws are dimensioned such that their facing surfaces can be easily moved slidably past each other. In some of these embodiments, the second arcuate track substantially resides within an enclosure formed by the first arcuate track. Although the proximally positioned arcuate tracks are rotatable with respect to each other, in some embodiments, at least the proximal portion of the first jaw is fixed with regard to the shaft, while the second jaw is pivotable with respect to the shaft.
In some embodiments of the pinless rotation mechanism, the first arcuate track has two concentric surfaces facing each other, one smaller and the other larger, and the second arcuate track has two concentric surfaces facing away each other, one smaller and the other larger. The concentric surfaces of the two tracks are mating surfaces between the tracks. More particularly, the smaller concentric surfaces of the first and second tracks, respectively, are complementary to each other. The larger concentric surfaces of the first track and second track, respectively, are complementary to each other. The second arcuate track substantially resides within an enclosure formed by the first arcuate track. In particular embodiments, the first jaw includes a retaining strap that backs the smaller concentric surface of the first arcuate track and is positioned laterally across a surface of a housing of first jaw within a portion of the housing overlaying and securing the smaller concentric surface of the second jaw. This strap is configured to retain the proximal aspect of the second jaw within the enclosure provided by the first arcuate track.
From a general perspective, in embodiments of the device in which the shaft and the jaws are freely rotatable with respect to a handle portion, designating one jaw as a lower jaw and the other jaw as an upper jaw may not be particularly meaningful. Nevertheless, in some embodiments of the device, by virtue of a convention, or by some designation, there may be a default rotational position of the jaws that particularizes one jaw as a lower jaw and the other as an upper jaw. Thus, in particular embodiments of the device, and in the examples of device embodiments depicted herein, from the perspective of an operator of the device and with the jaws in a default operating position, a referenced first jaw is a lower jaw and a referenced second jaw is an upper jaw.
Typical embodiments of an electrosurgical device as described herein may have one jaw that is pivotable with respect to the shaft and a second jaw having at least a base portion that is fixed with respect to the shaft. Embodiments such as these are described in detail herein, and are depicted as examples in the figures. Alternative embodiments of the device, however, may be configured such that both jaws are pivotable with respect to the shaft.
Typical embodiments of the device as described herein are also configured such that one jaw is a two-piece jaw, including a proximal base piece and a distal piece that is pivotable with respect to the proximal base piece, and a second jaw that is unitary. Embodiments such as these are described in detail herein, and are depicted as examples in the figures. Alternative embodiments of the device, however, may be configured such that both jaws have two pieces, with a distal portion that is pivotable with respect to a proximal base portion.
Embodiments of an electrosurgical device as provided herein may vary in tennis of the distribution of features between a first jaw and a second jaw. Thus, in some embodiments of the device (Embodiment A), a first jaw (a lower jaw, for example) is a two-piece jaw, having a proximal piece that is fixed with respect to the shaft, a distal jaw piece that is pivotable with respect to the proximal piece, and a pivotable assembly connecting the proximal piece and the distal jaw piece; and a second jaw (an upper jaw, for example) is unitary and pivotable with respect to the shaft.
In alternative embodiments of the device (Embodiment B), a first jaw (a lower jaw, for example) is unitary and fixed with respect to the shaft; and a second jaw (an upper jaw, for example) is a 2-piece jaw, having a proximal jaw piece that is pivotable with respect to the shaft, a distal jaw piece that is pivotable with respect to the proximal piece, and a pivotable assembly connecting the proximal jaw piece and the distal jaw piece. Examples of both embodiments A and B are depicted as examples in the figures.
In another aspect, Embodiment A of the device may be described as having two jaws, a first jaw that is fixed with respect to the shaft and having pivotable electrode tray positioned with in it, and a second jaw being pivotable with respect the shaft and having a fixed electrode tray disposed within it. Embodiment B of the device may be described as having two jaws, a first jaw that is fixed with respect to the shaft and having a fixed electrode tray disposed with in it, and a second jaw that is pivotable with respect to the shaft, and having a pivotable electrode tray with in it. Other than the variation associated with the distribution of jaw attributes between Embodiments A and B, other features of the Embodiment A and Embodiment B devices are substantially similar. The majority of features shown in figures included herein are consistent with Embodiment A or common to both Embodiments A and B.
A further embodiment (Embodiment C) of the device may be described as having two jaws, a first jaw that is fixed with respect to the shaft and having a pivotable electrode tray positioned with in it, and a second jaw that is pivotable with respect to the shaft, and having a pivotable electrode tray with in it. Still further embodiments have both jaws pivotable with respect to the shaft. Thus Embodiment D has two jaws that are pivotable with respect to the shaft; it has a first jaw having a pivotable electrode tray positioned within it and a second jaw having a fixed electrode tray disposed with in it. Embodiment E has two jaws that are pivotable with respect to the shaft, both jaws having a pivotable electrode tray positioned within it.
In some aspects of the disclosure, an embodiment of the device consists of a set of jaws as described herein, but which are specifically absent a shaft, absent a handle, or absent both a shaft and a handle. The set of jaws per these embodiments may be appropriately fitted onto a shaftless device, or alternatively, onto a robotic device. These embodiments may or may not be configured for electrosurgery. Some embodiments include bipolar electrodes; some embodiments may be configured for mechanical functions without being enabled to deliver radiofrequency energy. These embodiments may further include various aspects of the technology disclosed herein, such as having a diameter that is no greater than about 5 mm, having a pinless rotation mechanism to open and close the jaws, or the jaws may include longitudinally aligned self-aligning features.
Some embodiments of an electrosurgical device include a blade that is capable of separating radiofrequency-sealed tissue into two portions. Embodiments of the blade maybe be positioned on a longitudinally disposed blade track; the blade may be positioned at home position at a proximal end of the track, at a distal end of the track, or at any point along the track between the distal and proximal ends of the track. In various embodiments of the device, when the jaws are in the open position, the proximal home position of the blade is configured such that the movement of the blade in a distal direction is prevented. In some embodiments, distal movement may be physically blocked by an impeding structure distal to the blade, in other embodiments distal movement may be prevented by a locking mechanism proximal to the blade.
On the other hand, when embodiments of the jaws are in the closed position, the proximal home position of the blade may be configured to allow distal movement of the blade, the first and second jaws collectively forming a clear through path to the distal end of blade track. The availability of the space for the through-path is, at least in part, due to the pinless aspect of the rotation mechanism in that the presence of a pin, for a pin-based jaw rotation mechanism, could otherwise occupy the space, and impede the path. The through path of the blade includes slots and clefts through various structures, as described below in the context of the figures. In typical embodiments of a blade of the configuration described, the blade is distal facing with a leading V-shaped notch, which cuts tissue as it is moved distally. At its proximal end, the blade is connected to a mechanical linkage in the handle that maintains it in a proximally biased position.
As noted above, dimensions of embodiments the electrosurgical device are important aspects of the technology, as embodiments of the device are intended to be compatible with trocars having an inner diameter of about 5 mm (in the conventional or commercial sense as described above). Thus, in particular embodiments, the set of jaws, when closed, has a diameter no greater than about 5 mm when the device is in an insertable configuration. An insertable configuration for a device with openable jaws is one, for example, in which the set of jaws is in a closed configuration, and wherein the jaws of the device are aligned with the longitudinal axis of the shaft. Thus, in particular embodiments of the technology described, the shaft has a diameter no greater than about 5 mm, and the set of jaws, when closed, provides a maximum diameter of about 5 mm.
Other dimensions and structural features of the technology are directed toward features and operational specifications of embodiments of the device that also need to accommodate the constraints imposed by the requirement for a 5 mm maximal diameter. For example, in particular embodiments, the jaws have a length of at least about 2.5 cm. Further, some embodiments of a 5 mm diameter constrained device that has jaws with a length of at least about 2.5 cm are able to exert a pressure in the range of about 14 lbs. to about 28 lbs. at the tip of the jaws, and in particular embodiments, the jaws are able to exert a pressure of at least about 16 lbs. at their tip.
One of the approaches to delivering high surgical performance from an electrosurgical device with 5 mm diameter constraint is to minimize the cross sectional area that is occupied by components or materials that do not provide distally projecting or contiguous structural support to the jaws, and particularly to support their ability to deliver sufficient closing force. Here are some examples of a material or component that could located in this region that do not lend distally projected support, or which interrupt longitudinal structural continuity in a portion of the cross sectional area of a device. One could consider a pin positioned orthogonally across a portion of the proximal aspect of the jaws, to be used, for example, as a structure upon which other features might pivot or rotate. A pin of this nature, while performing an operational role, does not strengthen the ability of the jaws to exert a compressive force, nor does it strengthen the ability of the jaws to maintain their position when the jaws encounter resistance provided by body structures within the laparoscopic operating space. Typical embodiments of provided device do not have a pin. Another example of a component occupying cross sectional area that does not provide distally projected structural support to the jaws relates to actuator members and electrically conductive members. Some embodiments of the provided device have connecting members that serve both a physical actuating function and an electrically conductive function, thus conserving cross sectional structural area. By these various aspects of embodiments of the device, the cross sectional fraction of the device that does not provide distally projecting structural support may be minimized.
Accordingly, with regard to a cross sectional slice taken through a portion of the device that includes the pinless rotation mechanism, in some embodiments of the device, a ratio of the structural material that contributes to supporting the set of jaws to the total cross sectional area of the device is at least about 82%. A similar analysis of distally directed structural support could make use of a volume-based constraint. For example, the central portion of the distal end of the device, at least the proximal aspect of the set of jaws, can include a given length of the shaft and/or jaws within proximal and distal boundaries. If that given length is multiplied by cross-sectional area within the set of distal and proximal boundaries, it may be understood that a measure of structural material can report structural material in terms of its volume and can be expressed as a percent of the total volume of the device portion within the boundaries.
As summarized above, some embodiments of the set jaws are configured in a manner such that the jaws self align with respect to their longitudinal axes when the jaws are approaching closure. Accordingly, in these jaw set embodiments, the tissue-engaging surfaces of each of the opposing jaws, respectively, have mutually complementary longitudinally oriented self-aligning features that prevent lateral slippage of jaws as they close toward each other. Inasmuch as these features prevent or correct incipient lateral slippage as the jaws close, these features may be characterized as longitudinally aligning and laterally stabilizing aspects of the tissue-engaging surfaces.
Embodiments of self-aligning jaw features may be disposed along the substantial entirety of the length of the jaws. In another aspect, embodiments of self-aligning jaw features may as occupy the substantial entirety of available tissue engaging surfaces of the jaws. In various embodiments, the self-aligning features may fully or substantially occupy the length tissue-engaging surfaces of the jaws; in other embodiments, the self-aligning features may occupy only a portion of the length of tissue-engaging surfaces of the jaws. The structural features associated with this approach to longitudinally aligning the jaws generally conserves on materials, costs, or dimensions, that would otherwise be associated with achieving manufacturing tolerances required to support a guarantee of collinear alignment of the two jaws when they close.
In particular embodiments, the self-aligning configuration of the tissue-engaging surfaces of the jaws includes a longitudinally aligned V-shaped projecting surface on one jaw and a complementary longitudinally aligned V-shaped receding surface or recession on the other jaw. In some embodiments, the V-shaped projection is on the lower jaw, and the V-shaped recession is on the upper jaw. The longitudinally aligned V-shaped projecting surface on one jaw and the complementary longitudinally aligned V-shaped receding surface on the other jaw, when the set of jaws is closed, form a V-shaped common interface with internal angle in the range of about 90 degrees to about 175 degrees. In particular embodiments, the V-shaped common interface has internal angle about 150 degrees.
In a more general aspect, the self-aligning configuration of embodiments of the tissue-engaging surfaces of the jaws, in a lateral cross section, form a zone or interface of tissue contact more complex than that of a single straight cross-sectional line. By virtue of being non-linear, the width of the contact zone between the closed jaws and the grasped tissue is greater than would be the tissue width of a linear tissue contact zone. Thus, the width of the tissue seal created by the V-shaped configuration of the tissue engaging surfaces of the jaws is greater than would be the width of a tissue seal created by flat tissue engaging surfaces. The arrangement just described, of complementary V-shaped projection and V-shaped recession forming a V-shaped zone of tissue being contacted by such jaws, is just one example of self-aligning tissue engaging surfaces.
In some embodiments of the technology, the electrosurgical device has an insulative layer applied over aspects of at least one of the opposing jaws, the insulative layer forming a spatial gap between the upper jaw and the lower jaw that prevents any direct electrical connection therebetween. In various embodiments, each jaw tip each has an electrically conductive surface on or within its tissue-engaging surface, and an aspect of the insulative layer includes strips aligned across the electrically conductive surface of at least one of the forcep tips. The strips farm a gap between the electrically conductive surfaces of the two jaws when the jaws are in a closed position. Such a gap is typically about 0.006 inch; more generally, the gap has a range of about 0.0045 inch to about 0.0075 inch. In various embodiments of the insulative layer, it may include a polymer, such as polyether ether ketone (PEEK), merely by way of example. In other embodiments, the insulative layer may include a ceramic material, such as any of alumina or alumina-titania, merely by way of example. Ceramic compositions can be advantageous for their relative hardness, incompressibility, and/or general durability. In some embodiments, the ceramic material is positioned at one or more sites on the surface of the device that are particularly subject to abrasive and/or compressive stress.
In some embodiments of the technology, the device includes a handle portion proximal to the shaft, a jaw actuator mechanism associated with the handle portion and configured to actuate a mechanical capability of the jaws, and a jaw actuator wire connected proximally to the actuator mechanism and connected distally to the set of jaws. In various embodiments, the mechanical capability of the jaws includes opening and closing the set of jaws. In some embodiments, the actuator wire is configured to actuate an opening and closing of the jaws by pivoting a second jaw with respect to at least a proximal piece of the first jaw, the proximal piece of the first jaw being fixed with respect to the shaft.
Further, in some embodiments, the same wire that serves as a mechanical actuator force transfer member is further configured to deliver RF energy to the jaws. From another perspective, embodiments of the device include an energy-delivery wire extending distally from the handle portion to the set of jaws. In some of these energy-delivery wire embodiments, the energy-delivery wire may be further configured to perform as an actuator of mechanical capability of the jaws, such as moving the jaws between an open and a closed position.
Some embodiments of the jaw actuator wire include a single wire in looped configuration that, in effect, forms a paired or double wire connection between the actuator mechanism and an attachment site on at least one of the jaws. In these embodiments, the looped wire has a distal-most looped terminal or turn around portion that is looped around its attachment site to one of the jaws. In embodiments wherein at least the proximal piece of the first jaw is fixed with respect to the shaft and the second jaw is pivotable with respect to the shaft, the actuator wire is attached to a proximal aspect of the second jaw.
In some embodiments, the actuator wire is configured as a push and pull mechanism, such that a distally-directed push from the wire moves the jaws to their open position, and a proximally-directed pull from the wire moves the jaws to their closed position. In some of these embodiments, the actuator wire is biased so as to support the jaws in their open position by virtue of a proximally directed pull by a spring associated with the jaw actuator.
In some embodiments, the jaw actuator includes a biasing member that maintains a push on the actuator wire, such push causing the jaws to have a default position of being held in the open position. Further, in some embodiments, the jaw actuator includes a manual lever that an operator may pull to effect a proximally-direct pull to close the jaws. Further still, in some of these embodiments, the actuator wire and connections associated with proximal and distal attachments of the wire are collectively configured to be able to operationally withstand between about 80 and about 120 lbs. of tension; in particular embodiments the actuator wire and its connections are configured to be able to withstand at least about 100 lbs. of tension.
In some embodiments of the device, each of the upper jaw and the lower jaw include a metal portion, and the entirety of each of these metal portions form an electrode. In other words, in some embodiments, there is no metal portion in either jaw that is not part of the electrode. In some embodiments, the device includes a single bipolar electrode pair, one electrode in each of the jaws. In these single bipolar pair embodiments, the electrodes are powered by a generator operating on a single radiofrequency channel. Other embodiments of the device may include a plurality of bipolar electrode pairs, and such plurality of bipolar electrode pairs may be controlled by a plurality of operating radiofrequency channels.
Some embodiments of the electrosurgical device include a shaft rotational actuator positioned proximal to the shaft; embodiments of the shaft rotator are typically associated with a handle portion of the device. In some embodiments, the shaft rotational actuator is configured to be able to rotate freely in both clockwise and counter clockwise directions, such rotation of the actuator being directly translatable to rotation of the shaft, and in turn, rotation of the set of jaws about their longitudinal axis. Free rotation in this context, whether in reference to a shaft rotator, the shaft, or the jaws, per embodiments of the technology, refers to a rotation that may occur indefinitely in either direction, without a stop, and without a change of direction. Further, per embodiments of the technology, rotation may freely occur without consequence or compromise with regard to any mechanical or electrical capability of embodiments of the electrosurgical device.
In some embodiments of the electrosurgical device, the set of two opposing jaws (including a first jaw and a second jaw) is configured such that the jaws can open to an angle in the range of about 30 degrees to about 40 degrees. In some the set of two opposing jaws is configured such that when the set is moving from an open position toward the closed position, a first point of mutual contact between the two jaws occurs at a distal end of each jaw. The set of jaws may be further configured such that after the first point of mutual contact has been made and as the set moves further toward a closed position, a distal pivotable piece of the first jaw pivots within a plane of its longitudinal axis such that the proximal end of the first jaw comes into contact with the proximal end of the second jaw.
In some embodiments, the set of two opposing jaws is configured such that when the set of jaws is moving from an open position toward the closed position, a first point of mutual contact between the two jaws occurs at a distal end of each jaw. In some of these embodiments, after the first point of mutual contact has been made and the jaw set is then moving further toward a closed position, a distal pivotable piece of the first jaw pivots within a plane of its longitudinal axis such that the proximal end of the first jaw comes into contact with the proximal end of the second jaw.
Some embodiments of the device and its dynamics of closing may be understood in terms of the response of the jaws to the presence of target tissue within the grasp of closing jaws. In some embodiments, for example, the set of jaws may be configured such that when the set is moving toward the closed position and has made an initial contact with the target tissue, a pivotable piece of the first jaw then pivots in response to the presence of the target tissue as the jaws move further toward the closed position to grasp the tissue. The pivoting of the pivotable jaw piece may effect a substantially equivalent distribution of pressure along the grasped piece of the target tissue, particularly in comparison to the unequal distribution of pressure that may occur in the absence of such intra-jaw pivotability. In a related aspect of the device, the pivotable jaw piece is configured to pivot toward a parallel relationship with the second jaw.
In various embodiments, the pivotable jaw piece may be configured such that it can pivot around its pivotable connection within an arc having pivotable range that varies between about 2 degrees to about 8 degrees. In particular embodiments, the pivotable jaw piece may be configured such that it can pivot around its pivotable connection within an arc having a pivotable range of about 6 degrees. In another aspect, the pivotable jaw piece has an arc of a given pivotable range and is biased such that a distal tip of the first jaw is canted toward the second jaw within the arc of pivotable range.
In some embodiments, the first jaw includes a proximal jaw piece fixed with respect to the shaft, a pivotable distal jaw piece, and a pivotable assembly that connects the proximal jaw piece and distal jaw piece. In various of these embodiments, the pivotable assembly may be positioned longitudinally at a substantially central site on the distal piece. In some of these embodiments, a tissue engaging surfaces comprises the substantial entirety of the distal and pivotable piece of the first jaw. Accordingly, a central location on the distal piece of the jaw also represents a central location with respect to a tissue-engaging surface of the jaw. In another aspect of some embodiments, the substantial entirety of the tissue engaging surface of the distal piece of the first jaw comprises an electrode. Thus, a central site on the distal piece of the first jaw represents a central site on the electrode. The centrality of the site of the pivotable assembly on the distal and pivotable jaw piece may be related to ability of the distal piece to pivot in such a manner so as to evenly distribute pressure across the surface target tissue as the jaws close on the tissue. In some of these embodiments, the pivotable assembly may include a laterally projecting boss on each of both sides of the distal pivotal jaw piece and an internally accessible receptacle on each of both sides of the proximal fixed jaw piece, the laterally projecting bosses and the internally accessible receptacles being mutually compatible. Other arrangements and configurations that support a pivoting capability such as that described and depicted herein are known in the art, and are be considered to included in the scope of the present technology.
In some embodiments of the device, with reference to a method of fabrication, the proximal and distal pieces of the two-piece jaw may be assembled in a snap fit manner. More particularly, in such embodiments, the fixed proximal jaw piece is sufficiently flexible that it can deflect to allow the insertion of the laterally projecting bosses of the distal pivotable jaw piece in a snap fit manner.
Another aspect to the pivoted bias of the distal and pivotable piece of a two-piece jaw relates to a biasing member that maintains the pivotable piece in a default pivot position. In some embodiments, for example, the distal pivotable piece of the first jaw includes a biasing member that is configured to press against a shelf of the proximal jaw piece, and by such pressing bias the distal pivotable piece of the first jaw such that the distal tip of the distal pivotable piece is canted toward the second jaw. With more particularity, in some of these embodiments, the biasing member takes the form a leaf spring positioned in a recess within the distal pivotable piece on an aspect of the distal pivotable piece that faces the fixed proximal piece of the first jaw.
In another aspect, the technology provides a surgical device having a set of opposing jaws disposed distal to a shaft, the set of jaws having a first jaw and a second jaw. Each of the opposing jaws has a longitudinal axis and a tissue-engaging surface, and the tissue-engaging surface of each jaw may have a complementary self-aligning configuration with respect to the longitudinal axis of the other jaw. In some embodiments of the provided surgical technology, the set of jaws, when closed, has a diameter no greater than about 5 mm, and the shaft has a diameter no greater than about 5 mm. Embodiments of the surgical device may further include a pinless rotation mechanism formed from rotatably cooperative features of the first jaw and the second jaw. This pinless rotation mechanism enables the set of jaws to pivot between an open position and a closed position. The pinless rotation mechanism is configured such that the pinless rotation mechanism creates a common center of rotation that is not necessarily positioned at a point on a line corresponding to a central longitudinal axis of the shaft.
Embodiments of the technology further relate to a method of electrosurgical sealing in a laparoscopic environment. The method may include moving a set of jaws of an electrosurgical instrument into a proximity of the target tissue, the set of jaws comprising a first jaw and a second jaws. More particularly, moving toward an electrosurgical site may include advancing a distal portion of an electrosurgical device into a patient through an in-place trocar having an internal diameter of about 5 mm. The distal portion of the electrosurgical device, in this circumstance, includes a distal aspect of a shaft and the set of jaws, including a first jaw and a second jaw, that are positioned on a distal end of the shaft. Embodiments of the method may include moving the jaws between an open position and a closed position. Moving the jaws between an open position and a closed position opening may include rotating cooperative structures of the first jaw and the second jaw, the first and second jaws not being connected by a pin. Moving the jaws to a closing position may further include grasping the target tissue with the jaws. The method may still further include delivering radiofrequency energy to the target tissue from the jaws.
In some embodiments of the method, moving the set of jaws into a proximity of the target tissue further includes rotating the jaws around their central longitudinal axis. Rotating the jaws may occur by way of rotating the shaft of the device around its central longitudinal axis. Rotating the shaft of the device may occur by rotating a shaft rotation actuator proximal to the shaft. In various embodiments of the method, embodiments of the shaft rotation actuator, the shaft, and the jaws may all have the capability of rotating freely in both clockwise and counter clockwise directions without a stop, or a need to reverse direction.
In some embodiments of the method, moving the jaws between an open position and a closed position opening includes rotating cooperative structures of the first jaw and the second jaw at their respective proximal ends, the first and second jaws not being connected by a pin. Moving the jaws between an open position and a closed position opening may include pivoting the jaws with respect to each other around a center of rotation that is not necessarily on a line corresponding to a central longitudinal axis of the shaft. In some embodiments, moving the jaws between an open position and a closed position opening includes pivoting the jaws around a center of rotation that is not on a line corresponding to a central longitudinal axis of the shaft, and in some embodiments, the center of rotation may be displaced to a position beyond the diameter of the shaft.
In another aspect, moving the jaws between an open position and a closed position opening may include at least a proximal piece of a first jaw remaining fixed with respect to the shaft and a second jaw pivoting with respect to the shaft. In some of these embodiments, moving the jaws to the closed position may included a distal piece of the first jaw pivoting with respect to the proximal piece of the jaw, and thus pivoting with respect to the shaft. In some embodiments, the pivoting of the distal piece of the first jaw with respect to the shaft includes the distal end of the distal piece pivoting away from the second jaw and the proximal end of the distal piece pivoting toward the second jaw.
In some embodiments of the method, moving the jaws to a closed position includes pivoting a distal piece of the first jaw from a pivotable connection that is positioned at a substantially central portion of the distal piece. In some aspects of the method, there is an interaction between the jaws as they are closing and the target tissue that the jaws are closing around. Thus, in some embodiments, pivoting the distal piece of the first jaw includes pivoting in response to the presence of the target tissue between the jaws, in such a manner that distributes pressure with substantial equivalence along the grasped portion of the target tissue. Further, pivoting a distal piece of a first jaw from a connection positioned at a substantially central portion of the distal piece comprises pivoting in response to the presence of the target tissue between the jaws, thereby allowing the distal piece of the first jaw to pivot toward a parallel alignment with respect to the second jaw.
In some embodiments of the method, moving the jaws to a closed position includes mutually aligning the respective central longitudinal axes of the first and second jaws. In instances when the jaws are moving to a closed position so as to grasp tissue, moving the jaws to a closed position may include mutually aligning the respective central longitudinal axes of the first and second jaws comprises in such a manner so as to resist a misaligning effect of target tissue have on the jaws as they are closing.
In some embodiments of the method, moving the jaws to a closed position comprises grasping the target tissue with a force in a range of about 14 lbs. to about 28 pounds. Further, in some embodiments, moving the jaws to a closed position includes grasping a portion of target tissue of up to about 2.5 cm in length.
In some embodiments of the method, opening and then closing the jaws includes transferring a force from a mechanical actuator to the jaws via an actuator wire. In some of these embodiments, closing the jaws includes pulling the actuator wire in a proximal direction, and in some embodiments, opening the jaws pushing the actuator wire in a distal direction. In some embodiments of the method, delivering radiofrequency energy to the target tissue may include delivering energy to the jaws via the actuator wire.
In some embodiments of the method, moving the jaws to a closed position includes moving the jaws toward a closed position in a manner such that a first point of mutual contact between the two jaws occurs at a distal end of each jaw. In some of these embodiments, moving the jaws to a closed position after the point of first mutual contact has occurred includes pivoting a distal pivotable piece of a first jaw within a plane of its longitudinal axis such that the proximal end of the first jaw comes into contact with the proximal end of the second jaw.
In some embodiments of the method, delivering radiofrequency energy to the target tissue includes energy through a wire that is further enabled to perform a mechanical function, such as actuating the jaws between an open and closed position. In various embodiments of the method, electrosurgically treating tissue particularly includes sealing edges of target tissue together.
In some embodiments of the method, after delivering radiofrequency energy to the target tissue, the method further includes separating newly sealed target tissue into two sealed tissue segments. In various embodiments, separating newly sealed target tissue into two sealed tissue segments includes advancing a blade distally through sealed target tissue.
Some embodiments of the method include electrosurgically treating more than one site during a single procedure, or treating a lengthy target site with a series of sealing maneuvers. Thus, some embodiments of the method further include identifying a second target site and then repeating the steps of grasping and delivering energy, the steps being directed toward the second target site.
Embodiments of the technology described herein provide various improvements over available electrosurgical devices, such improvements permitting a physical downsizing of a device to a dimension that permits practical use of an electrosurgical device within the constraints of a laparoscopic surgical environment. One of these constraints to working laparoscopically relates to the 5 mm inner diameter opening provided by a commercially standard trocar. A device compatible with the 5 mm opening constraint needs to have an insertable configuration with a maximal diameter that is insertable therethrough. These technological improvements are generally directed toward creating a high degree of efficiency with regard to performance of the device per unit volume or cross sectional area. For example, a jaw set of a disclosed device, in spite of small physical dimension, is able to deliver an appropriate level of force to tissue being clamped by the jaws, and the structure and material of the jaws have sufficient strength to maintain integrity during the delivery of such force.
In one aspect, the technology includes maximizing the amount of structural material in particular areas as a percent of total amount of device material. The proximal aspect of the jaw set, for example, includes various components, some that contribute structural support for the jaws, and other components that perform other functions, such as mechanical or electrical functions. The technology, in this aspect, is directed toward minimizing cross sectional area or volume that does not directly support the jaws. Some components of conventional electrosurgical devices are typically dedicated to a single use, such as electrodes, power lines, or actuator lines; in contrast, various components of embodiments of the presently disclosed device do double duty both as structural and electrical components in embodiments of the technology. In another example of material and occupied volume efficiency, some structural components, such as a pin connecting two jaws at their base, are eliminated and replaced by a pinless mechanism that links upper and lower jaws of a jaw set together.
Aspects of the technology in the form of embodiments of the disclosed electrosurgical device and methods of using the device are illustrated in
The shaft rotator 12 is configured to move freely in both clockwise and counterclockwise directions, and in so moving, rotates the shaft around its longitudinal axis. Rotation of the shaft translates into rotation of the end effector 30 around its longitudinal axis. The jaw actuator grip 15 is operably connected to end effector 30 by an actuation wire disposed within the shaft, which is configured to open and close the jaws. The actuation wire is configured as a push and pull mechanism, where in a push of the wire opens the jaws and a pull on the wire closes them. A biasing mechanism within the handle at the proximal end of the wire maintains a distal-ward bias that pushes the wire, maintaining the jaws in a default open position. A proximal pull on the jaw actuator grip 15 pulls the actuator wire proximally, causing the jaws to pull. The jaw actuator grip is lockable in its proximally pulled position, thereby locking the jaws in a closed position. A second pull on the jaw actuator grip releases the lock, thereby allowing the jaws to open. The blade actuation lever 16, positioned in this embodiment distal to the jaw actuator grip, is connected by mechanical linkage to a blade disposed within the shaft. A pull on the blade actuation lever moves the blade forward distally, to effect a separation of tissue after it has been sealed by radiofrequency energy delivered to the tissue by bipolar electrodes within the set of jaws. A radiofrequency on/off button 24 is positioned at an upper proximal site on the handle.
Embodiments of electrosurgical devices, as described herein, may be configured such that the (1) provision of radiofrequency energy delivery to seal tissue portions and (2) the movement of the blade to sever or separate sealed tissue portions are separate and independent operations. Distal movement of the blade from its proximal home position is typically allowed only when the jaws are closed and in a locked position, the locking occurring by way of engagement between the jaw actuator grip and elements within the handle. (As described further below, in the context of describing
An embodiment of a pinless rotation assembly 101, as shown in
Both of the first and second arcuate tracks include concentric surfaces, one surface smaller and more central to the other, and the other surface larger and more peripheral to the other. First arcuate track 45 of lower jaw 40 (more particularly of proximal portion 50 of lower jaw 40) has a larger concentric engagement surface 46 on its lower aspect, and it has a smaller concentric surface 47 on its upper aspect. Second arcuate track 85 of upper jaw 80 has a larger concentric engagement surface 86 on its lower aspect, and it has a smaller concentric surface 87 on its upper aspect. As a whole, second arcuate track 85 (of upper jaw 80) is generally contained within an enclosure provided by first arcuate track 45 (of lower jaw 40). The first and second arcuate tracks are dimensioned such that the second arcuate track can freely rotate within first arcuate track. The two larger concentric surfaces, i.e., the lower surface 46 of the lower jaw and the lower surface 86 of the upper jaw are complementary. And the two smaller concentric surfaces, i.e., the upper surface 47 of the lower jaw and the upper surface 87 of the upper jaw are complementary.
A detail of both first and second arcuate tracks, not seen in
Also shown in
The pivoting of upper jaw 80 pivots upward so as to move jaw set into an open position is driven by the rotation of second arcuate track 85 within the enclosure of first arcuate track 45. As seen in
Other than the variation in the configuration of the jaws as just described, other aspects of embodiments A and B are substantially the same. In particular, the dynamics of the closing of the jaws of Embodiment B are the substantially the same as those of Embodiment A, which are described in detail below, in the context of
A clockwise rotation or pivoting of pivotable jaw piece 60 (of lower jaw 40) results in its distal end or tip 66 assuming a relatively high profile and its proximal aspect assuming a relatively low profile with respect to proximal jaw piece 50. The differences in profile are relatively subtle, but are apparent when the proximal aspect of the upper profile of the surface of electrode 62 is viewed in relationship to the upper surface of the proximal aspect of the proximal jaw piece 50. In
A non-parallel closure of jaws, as is typical of conventional jaws that do not have intra-jaw pivotability or another compensatory mechanism, can have therapeutically unsatisfactory consequences, such as uneven distribution of pressure on tissue along the line of jaw contact, as well as uneven distribution of radiofrequency energy when delivered by electrodes. Embodiments of a set of jaws as provided herein, however, can of course still be confronted with a portion of target of tissue that exceeds their capacity for parallel closure of tissue engaging surfaces of jaws. However, as noted, the thickness of tissue that would account for the configuration of the jaws as seen in
This relative positioning of the jaw embodiments as seen in
In contrast,
As summarized above, embodiments of the pivotable connection or assembly 75 provide a pivotable range of about 2 degrees to about 8 degrees; particular embodiments are configured to pivot within a range of about 6 degrees. The relationship between the pivoting of distal jaw piece 60 and the dynamics associated with opening and closing the jaws, with and without tissue being grasped between them, is described above in the context of
In
As seen in these various views, the proximal end of shaft 20 terminates into a proximal shaft-associated assembly that includes an actuation collar 307 around which is slidably wrapped within a power tube 313. Proximal to actuation collar 307 are a control flange 303 and a control post 301. A jaw actuator engagement groove 305 is disposed between control flange 303 and control post 301. The actuation collar and its wrap around power tube are disposed within the partially enclosing U-shaped proximal electrical connector 311. The actuation collar and power tube are both rotatable and slidable within the proximal electrical connector. Actuation of the rotation of the shaft (and the actuation collar and power tube) is controlled by rotation actuator 12, as shown in
The proximal electrical connector 311 delivers radiofrequency electrical energy to power tube 313 through a secure but slidable contact that is maintained regardless of the rotational position of the power tube, and regardless of the distal to proximal translational position of the power tube. Electrical energy is conveyed by this path from a generator that is part of a larger electrosurgical system to cables 22 that terminate proximally within actuation collar 307 at a proximal cable attachment site 310. A collar plug 309 that fills an asymmetric space within a proximal aspect of actuation collar 307 serves in several mechanical capacities, one of them being to secure cables 22 in their attachment to attachment site 310. Cables 22 terminate distally in an attachment to an upper jaw, as shown in
Electrical energy is also conveyed to distal electrical connector 315 from a system generator, and electrical connector 315 delivers energy to the shaft 20, which then conducts energy to the lower jaw piece 50. By these approaches, electrical paths to the upper jaw and lower jaw, respectively are segregated within the handle. Separate paths are maintained throughout the main body of the shaft, where electrical energy to the upper jaw travels through the centrally disposed twin cables 22, and where electrical energy to the lower jaw travels through the columnar shaft 20. Segregation of these two paths at the junction of the shaft and the jaws is described above in the context of
Unless defined otherwise, all technical terms used herein have the same meanings as commonly understood by one of ordinary skill in the art of surgery, including electrosurgery. Specific methods, devices, and materials are described in this application, but any methods and materials similar or equivalent to those described herein can be used in the practice of the present invention. While embodiments of the invention have been described in some detail and by way of illustrations, such illustration is for purposes of clarity of understanding only, and is not intended to be limiting. Various terms have been used in the description to convey an understanding of the invention; it will be understood that the meaning of these various terms extends to common linguistic or grammatical variations or forms thereof. It will also be understood that when terminology referring to devices or equipment, that these terms or names are provided as contemporary examples, and the invention is not limited by such literal scope. Terminology that is introduced at a later date that may be reasonably understood as a derivative of a contemporary term or designating of a hierarchal subset embraced by a contemporary term will be understood as having been described by the now contemporary terminology. Further, while some theoretical considerations may have been advanced in furtherance of providing an understanding of the technology, the appended claims to the invention are not bound by such theory. Moreover, any one or more features of any embodiment of the invention can be combined with any one or more other features of any other embodiment of the invention, without departing from the scope of the invention. Still further, it should be understood that the invention is not limited to the embodiments that have been set forth for purposes of exemplification, but is to be defined only by a fair reading of claims appended to the patent application, including the full range of equivalency to which each element thereof is entitled.
This application is a continuation of U.S. application Ser. No. 13/021,633, filed Feb. 4, 2011, which claims the benefit of priority of U.S. Provisional Patent Application No. 61/301,295 filed Feb. 4, 2010, now lapsed, and which is a continuation-in-part of U.S. patent application Ser. No. 11/743,579, filed May 2, 2007, now U.S. Pat. No. 8,574,229, which is a continuation-in-part of U.S. patent application Ser. No. 11/382,652, filed May 10, 2006, now U.S. Pat. No. 7,942,874, which claims priority to U.S. Provisional Patent Application No. 60/746,256, filed May 2, 2006, now lapsed.
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| Number | Date | Country | |
|---|---|---|---|
| 20180185087 A1 | Jul 2018 | US |
| Number | Date | Country | |
|---|---|---|---|
| 61301295 | Feb 2010 | US | |
| 60746256 | May 2006 | US |
| Number | Date | Country | |
|---|---|---|---|
| Parent | 13021633 | Feb 2011 | US |
| Child | 15905005 | US |
| Number | Date | Country | |
|---|---|---|---|
| Parent | 11743579 | May 2007 | US |
| Child | 13021633 | US | |
| Parent | 11382652 | May 2006 | US |
| Child | 11743579 | US |
