Embodiments of the present disclosure described herein relate to surgical devices, and in particular to a rotary shaver arrangement for a surgical instrument, an end effector for an electrosurgical instrument, an electrosurgical instrument, and an electrosurgical system.
Surgical instruments, including radio frequency (RF) electrosurgical instruments, have become widely used in surgical procedures where access to the surgical site is restricted to a narrow passage, for example, in minimally invasive “keyhole” surgeries. Electrosurgical instruments provide advantages over traditional surgical instruments in that they can be used for coagulation and tissue sealing purposes. Surgical apparatus used to shave, cut, resect, abrade and/or remove tissue, bone and/or other bodily materials are known.
In some electrosurgical instruments, e.g., shaver instruments, the instrument can include a cutting surface, such as a rotating blade disposed on an elongated inner tubular member that is rotated within an elongated outer tubular member having a cutting window. The inner and outer tubular members together form a surgical cutting instrument or unit. In this application, the inner and outer tubular members are also referred to as inner and outer blades. In general, the elongated outer tubular member includes a distal end defining an opening or cutting window disposed at a side of the distal end of the outer tubular member. The cutting window of the outer tubular member exposes the cutting surface of the inner tubular member (located at a side of the distal end of the inner tubular member) to tissue, bone and/or any other bodily materials to be removed. A powered handpiece is used to rotate the inner tubular member with respect to the outer tubular member while an outer tubular member hub (connected to the proximal end of the outer tubular member) is fixed to the handpiece and an inner tubular member hub (connected to the proximal end of the inner tubular member) is loosely held in place by the powered handpiece.
In some instruments the inner tubular member is hollow and has a cutting window on a side surface of its distal end such that tissue, bone, etc. will be cut or shaved as the cutting window of the inner tubular member aligns with and then becomes misaligned with the cutting window of the outer tubular member as the inner tubular member is rotated within the outer tubular member. In this regard, it can be said that the cutting device removes small pieces of the bone, tissue, etc. as the inner tubular member is rotated within the outer tubular member.
In some instruments a vacuum is applied through the inner tubular member such that the bodily material that is to be cut, shaved, etc. is drawn into the windows of the inner and outer tubular members when those windows become aligned, thereby facilitating the cutting, shaving, etc. of the tissue, which then travels through the inner tubular member due to the suction.
Some instruments, e.g., wet-field RF hand instruments for arthroscopy, use a saline suction pathway at the distal tip during either ablating or coagulating tissue. In general terms, suction provides the following benefits:
Many times during surgery, the surgeon wishes to apply RF energy to either coagulate bleeding vessels, or ablate tissue in the surgical site without performing cutting with a shaver instrument. This usually is done by withdrawing the shaver instrument and inserting a dedicated RF ablation/coagulation/suction device (for example, a RF wand which is a tube to which suction is applied). However, exchanging the surgical tool for the dedicated RF wand is time-consuming. Furthermore, insertion and removal of instruments into the patient can cause trauma and irritation to the passage of the patient, and thus it is desirable to minimize the number of times that surgical instruments need to be withdrawn and inserted/reinserted into the patient.
An RF shaver has both shaving and RF energy capabilities. In RF shaver electrosurgical instruments, the shaver side (the side on which the tissue, bone, etc. will be cut or shaved as the cutting window of the inner tubular member aligns with and then becomes misaligned with the cutting window of the outer tubular member as the inner tubular member is rotated within the outer tubular member) is opposite an RF side which has an electrode assembly with an active electrode for tissue treatment. The RF side is provided with a suction aperture.
An RF shaver electrosurgical instrument which optimises suction flow is desired.
The present disclosure optimises the RF suction flow path for an RF shaver instrument by providing a rotary shaver arrangement for a surgical instrument which prevents an unwanted secondary suction flow path from forming on the shaver side of the instrument at a wide range of angular positions of the inner tubular member. The angular positions of the inner tubular member may also be described as relative angular displacements between the inner and outer tubular members. The present disclosure achieves this by having the blade geometry close off the secondary unwanted suction flow path at a wider range of angular tolerance, without increasing the assembly complexity or component cost significantly. An end effector including the rotary shaver arrangement of the present disclosure is capable of different operations, including mechanical cutting of tissue, and electrosurgical ablation, sealing and/or coagulation of tissue.
Embodiments of the present disclosure provide a rotary shaver arrangement for a surgical instrument, the rotary shaver arrangement having a spline-shaped region in the cutting window of the inner and/or outer tubular member. The smooth nature of the spline-shaped region increases the range of angular positions at which an opening of the central suction lumen is created via the cutting windows of the rotary shaver. This is in comparison to a rotary shaver arrangement having a notch-shaped region in the cutting window of the inner and/or outer tubular member. The increased range of tolerance of mis-antialignment allows the user to close the opening of the central suction lumen with ease as less precision is required for the cutting windows to not overlap. “Anti-alignment” is defined herein as being aligned in an opposite direction, for example the cutting windows of the inner and outer tubular members are perfectly anti-aligned if they are facing in exactly opposite directions to each other i.e. facing 180° away from each other, and thereby facing in diametrically opposed directions away from each other. Therefore, in this application this refers to the first and second cutting windows being antialigned such that the first cutting window faces in a first direction and the second cutting window faces in a second direction precisely opposite the first direction. In contrast, the term “mis-antialignment” is hereby defined as being incorrectly antialigned, i.e., the first and second cutting windows are not exactly facing in opposite directions i.e. are not perfectly diametrically opposed, but are mis-antialigned, for example by having one window being slightly less or slightly more than 180° rotationally displaced from the other window.
In view of the above, from a first aspect, the present disclosure relates to a rotary shaver arrangement for a surgical instrument, the rotary shaver arrangement comprising: an outer tubular member with a first cutting window at the distal end thereof; and an inner tubular member rotatably mounted in a central passageway of the outer tubular member, the inner tubular member providing a central suction lumen, the inner tubular member having a second cutting window at the distal end of the inner tubular member. Wherein, the first and second cutting windows are arranged such that: (i) when the inner tubular member is rotated to a first range of angular positions, the first and second cutting windows overlap to form an opening of the central suction lumen; and (ii) when the inner tubular member is rotated to a second range of angular positions, the first and second cutting windows do not overlap and thus do not form the opening of the central suction lumen, and wherein one or more of the following is true:
Options (i), (ii) and (iii) all describe that the first and/or second cutting window comprises a spline-shaped region such that the opening of the central suction lumen is prevented from forming even if the first and second cutting windows are significantly mis-antialigned. This means that even if the first and second cutting windows (which ideally should be facing in opposite directions, i.e., have a relative angular displacement of 180°) are incorrectly positioned such that the relative angular displacement of the cutting windows is 150°, for example, the opening of the central suction lumen still does not form. In other words, the angular sensitivity to opening an unwanted suction pathway is drastically reduced. This optimises suction flow, especially during RF use of a dual-sided RF shaver device.
The notch-shaped region may comprise at least two vertices. The notch-shaped region may be such that a projection of the distal end of the inner and/or outer tubular member along the longitudinal axis of the inner and/or outer tubular member comprises at least one linear portion.
The position where the first and second cutting windows are antialigned is defined as the position where the inner tubular member is positioned at a relative angular position of 180° to that of the outer tubular member.
In some embodiments, the inner tubular member can be rotated more than 10, 15, 20, 25, 30 or 33 degrees from the position where the first and second cutting windows are antialigned without the opening of the central suction lumen forming.
In some embodiments, the second range of angular positions is greater than 15, 20, 25, 30, 40, 50, 60 or 66 degrees.
In some embodiments, the second range of angular positions includes the first and second cutting windows being antialigned, i.e., the inner tubular member is positioned at a relative angular displacement of 180° to the outer tubular member.
In some embodiments, the first range of angular positions includes the first and second cutting windows being aligned, i.e., the inner tubular member is positioned at a relative angular displacement of 0° to the outer tubular member.
In some embodiments, the second range of angular positions comprises the inner tubular member being positioned at a relative angular position of 170° to 190°, preferably 160° to 200°, more preferably 150° to 210°, more preferably 147° to 213°, to that of the outer tubular member.
In some embodiments, the spline-shaped region is such that a projection of the distal end of the inner and/or outer tubular member along the longitudinal axis of the inner and/or outer tubular member comprises a continuous curve and/or non-linear cut out. In some embodiments, the projection is part-oval.
In some embodiments, the first and/or second cutting window has at least one sharpened edge to form a cutting blade.
In some embodiments, the arrangement is such that, when in use, rotation of the inner tubular member within the outer tubular member causes a tissue cutting action of the cutting blade interacting with the second and/or first cutting window.
In some embodiments, the spline-shaped region is U-shaped. In contrast, the notch-shaped region may be described as an upside down Π shape. The notch-shaped region has harsh corners (or angular discontinuities) rather than the smooth profile of the U.
In some embodiments, when the first and second cutting windows align, they form a substantially oval-shaped interface. In contrast, when the first and second cutting windows of the notch-shaped arrangement align, they form a substantially rectangular-shaped interface.
From a second aspect, the present disclosure relates to an end effector for an electrosurgical instrument, the end effector comprising a rotary shaver arrangement according to any of the above-described embodiments; and a radio frequency (RF) arrangement including an active electrode comprising a suction aperture in fluid communication with the central suction lumen.
In some embodiments, the end effector is arranged such that the RF arrangement is positioned on a first side of the end effector, and the rotary shaver arrangement is positioned such that the direction of tissue shaving of the rotary shaver arrangement is on a second side of the end effector, the second side being opposite the first side. In other words, the end effector is a dual-sided RF shaver.
From a third aspect, the present disclosure relates to an electrosurgical instrument comprising: an end effector according to the any embodiment of the second aspect described above; and an operative shaft having RF electrical connections operably connected to the active electrode, and drive componentry operably connected to the rotary shaver arrangement to drive the rotary shaver arrangement to operate in use.
From a fourth aspect, the present disclosure relates to an electrosurgical system, comprising: an RF electrosurgical generator; a suction pump; and an electrosurgical instrument according to the third aspect, the arrangement being such that in use the RF electrosurgical generator supplies an RF coagulation or ablation signal via the RF electrical connections to the active electrode and the suction pump supplies suction via the central suction lumen connecting the suction aperture located within the electrode to the suction pump.
From a fifth aspect, there is provided a method for processing an instrument for surgery, the method comprising: obtaining the rotary shaver arrangement of the first aspect; sterilizing the rotary shaver arrangement; and storing the rotary shaver arrangement in a sterile container.
Embodiments of the invention will now be further described by way of example only and with reference to the accompanying drawings, wherein:
The Electrosurgical System
Referring to the drawings,
The Electrosurgical Instrument
The instrument 3 includes a proximal handle portion 3a, a shaft 3b extending in a distal direction away from the proximal handle portion, and a distal end effector assembly 3c at the distal end of the shaft 3b. A power connection cord 4 connects the instrument to the RF generator 1. The instrument may further be provided with activation buttons (not shown), to allow the surgeon operator to activate either the mechanical cutting function of the end effector, or the electrosurgical functions of the end effector, which typically comprise coagulation or ablation.
The instrument 3 may be an RF shaver instrument. An example of an RF shaver instrument is show in
For the shaver suction window to be closed, the cutting windows of the inner and outer tubular members need to be rotationally/angularly positioned such that there is no overlap between the two cutting windows. If there is the slightest overlap between the inner and outer cutting windows, an unwanted secondary suction path will form (i.e., an opening of the central suction lumen forms).
In this application, a relative angular displacement between the inner and outer tubular members of 0° means the cutting windows of the inner and outer tubular members are exactly aligned. Similarly, the inner tubular member being at an angular position of 0° means the cutting windows of the inner and outer tubular members are exactly aligned. Therefore, to optimise suction during RF use, the inner and outer tubular members will ideally be rotationally positioned with a relative angular displacement of 180° (i.e., the inner tubular member will ideally be at an angular position of 180°). In other words, the cutting window of the inner tubular member will be positioned facing in a first direction and the cutting window of the outer tubular member will be positioned facing in a second direction which is exactly opposite to the first direction. This results in zero overlap between the two cutting windows, and thus no unwanted secondary suction path (i.e., the opening of the central suction lumen is not formed). However, in practice, it is difficult to precisely rotationally/angularly position the inner tubular member such that this ideal placement is achieved.
To ensure that the unwanted suction flow path is not formed, one approach would be to have a highly accurate blade parking system such that the inner blade can be parked within this ˜6° threshold. It would be advantageous to control the blade parking system very accurately, and also specify very tight angular tolerances in the assembly of the instrument to ensure that this ˜6° threshold is not exceeded for this blade style. The disadvantages of this approach are a higher manufacturing cost due to tight tolerances, and a more complex blade parking control system architecture as the accuracy is critical. In this application, a less costly solution is explained to achieve a similar outcome.
Overview
Embodiments of the present invention involve a modification of the geometry of a blade of a rotary shaver arrangement to prevent an unwanted secondary suction pathway to (or opening of) the central suction lumen forming at a wider (with respect to an unmodified notch-shaped blade arrangement) range of relative angular displacements between the inner and outer blades or tubular members, without increasing the assembly complexity or component cost significantly.
This can be achieved through modifying either the outer or inner blade cutting geometry, i.e., the cutting windows of the outer or inner tubular members. It is anticipated that modifying the outer blade geometry/cutting window of the outer tubular member to reduce the size of the cutting window of the outer tubular member will create a disadvantage to the surgeon, because this will mean that during shaver mode usage less tissue will be able to be cut at once by the shaver, thus preventing the surgeon from engaging with as much tissue as they would like. This may also reduce tissue resection rates. Therefore, modifying the inner blade geometry/cutting window of the inner blade is preferable, although not essential as the advantages of the invention can still be realised by modifying the outer blade cutting geometry. Were the outer blade to be modified, it would be modified in a similar manner to the modification of the inner blade as described below, i.e., the geometry of the edge of the outer blade cutting window would be modified to provide more material to block off the unwanted flow pathway by using a spline-shaped region.
One solution proposed herein modifies the inner blade geometry over only the frontal hemispherical area which causes the secondary unwanted suction pathway, i.e., modifying the cutting window of the inner tubular member. The modification may be made only to the distal hemisphere of the inner tubular member. The modification provides more material in this area to block off the unwanted flow pathway. This is achieved with a spline-shaped region as shown in
Advantageously, the width and length of the cutting window of the modified tubular member may be unchanged from the arrangements shown in
The angular sensitivity to opening an unwanted suction pathway during RF use is drastically reduced with the solution proposed by the present application. The sensitivity of the notch-shaped arrangement shown in
It is noted that one slight disadvantage to the revised geometry is that the manufacturing cost for the inner blade could be marginally more expensive, however this is deemed to be a preferred solution compared to cost associated with tightening the angular tolerances of the entire RF shaver system and all components within it, to achieve the same end.
Various aspects and details of the modified geometry of the blade will be described below by way of example with reference to
In comparison,
The smooth curved nature of the spline-shaped cut-out of the modified inner blade geometry results in the unwanted secondary suction path being closed-off at a greater range of angular displacements (the angular displacement referring to the relative rotational angular displacement between the inner and outer tubular members) than the square nature of the notch-shaped cut-out of the unmodified inner blade.
The inner tubular member/blade 500 is rotatably disposed inside of the outer tubular member 630 such that the surgical instrument 3 cuts tissue by rotating the inner tubular member 500 within the outer tubular member 630 while a vacuum is applied through the lumen of the inner tubular member 500 to draw the tissue into the cutting windows and sever the tissue by rotation of the inner tubular member 500.
The RF side 610 of the electrosurgical instrument 3 comprises an electrode assembly comprising an active electrode for tissue treatment (“active tip”) 612 received in a ceramic insulator 614. The active tip 612 may be provided with projections to concentrate the electric field at those locations. The projections also serve to create a small separation between the planar surface of the active electrode 612 and the tissue to be treated. This allows conductive fluid to circulate over the planar surface and avoids overheating of the electrode or the tissue. The active tip 612 of the instrument is provided with a suction aperture 616, which is the opening to a lumen within the inner tubular member 500.
In more detail, when the RF side 610 is to be used as a suction tool by applying a vacuum through the lumen within the inner tubular member 500, the inner tubular member 500 (which acts as a cutting blade) is stopped from rotating and the cutting windows of the inner and outer tubular members are misaligned with each other, i.e. closing the cutting windows, so that the vacuum is applied through the suction path connecting the suction aperture 616 to the suction pump 10 via the lumen to transport fluids to and from the active tip 612. It is during this use that a key advantage of the invention becomes apparent. In arrangements with unmodified blades with cutting windows having a notch-shaped region (e.g. the arrangement of
In contrast, embodiments of the present disclosure provide an inner tubular member/blade 500 with a modified geometry comprising a spline-shaped region at its distal end such that a much greater angular tolerance is provided when closing the cutting window, and therefore provide a larger opening angle threshold of up to around ±33°. For example, the cutting window can be completely closed (no unwanted secondary suction pathway) when the inner tubular member 500 is positioned at an angle of around 147° to 213° with respect to the outer tubular member 630. This is a much larger angular tolerance than that of arrangements with unmodified blades comprising a notch-shaped region. As such, there is much less need for complex blade parking control system architecture as the accuracy of the positioning of the inner blade 500 is far less critical. See
In contrast, when the shaver side 620 is in use for a cutting operation, suction may flow via through the cutting windows to the lumen, and it is preferable that it does in order to draw the tissue-to-be-cut into the cutting windows and sever the tissue by rotation of the inner tubular member 500.
The inner and outer tubular members 500 and 630 may be made from stainless steel. Stainless steel is a good option as it is easy to bond to the steel cuttings tips of inner and outer tubular members, which act as the RF return, and due to the blade properties of hardened steel.
In
Reprocessing
The devices disclosed herein can be designed to be disposed of after a single use, or they can be designed to be used multiple times. In either case, however, the device can be reconditioned for reuse after at least one use. Reconditioning can include a combination of the steps of disassembly of the device, followed by cleaning or replacement of particular pieces, and subsequent reassembly. In particular, the device can be disassembled, and any number of particular pieces or parts of the device can be selectively replaced or removed in any combination. Upon cleaning and/or replacement of particular parts, the device can be reassembled for subsequent use either at a reconditioning facility, or by a surgical team immediately prior to a surgical procedure. Those of ordinary skill in the art will appreciate that the reconditioning of a device can utilize a variety of different techniques for disassembly, cleaning/replacement, and reassembly. Use of such techniques, and the resulting reconditioned device, are all within the scope of the present application.
Preferably, the invention described herein will be processed before surgery. First a new or used instrument is obtained and, if necessary, cleaned. The instrument can then be sterilized. In one sterilization technique, the instrument is placed in a closed and sealed container, such as a plastic or TYVEK® bag. The container and instrument are then placed in a field of radiation that can penetrate the container, such as gamma radiation, x-rays, or higher energy electrons. The radiation kills bacteria on the instrument and in the container. The sterilized instrument can then be stored in the sterile container. The sealed container keeps the instrument sterile until it is opened in the medical facility. The device may also be sterilized using any other technique known in the art, including but limited to beta or gamma radiation, ethylene oxide, or steam.
Various modifications whether by way of addition, deletion, or substitution of features may be made to above described embodiment to provide further embodiments, any and all of which are intended to be encompassed by the appended claims.
Number | Date | Country | |
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63404821 | Sep 2022 | US |