AU2003101053A4 - Apparatus and method for removing diathermy smoke or liquids from a surgical site - Google Patents

Description

P/00/011 Regulation 3.2

AUSTRALIA

Patents Act 1990 COMPLETE SPECIFICATION INNOVATION PATENT Invention Title: Apparatus and method for removing diathermy smoke or liquids from a surgical site The following statement is a full description of this invention, including the best method of performing it known to us: Freehills Carter Smith Beadle Melbourne 004414548 004414178 2 APPARATUS AND METHOD FOR REMOVING DIATHERMY SMOKE OR LIQUIDS FROM A SURGICAL SITE Field of the invention The present invention relates to apparatus and methods for removing liquids or gases such as diathermy smoke or both from a surgical site.

Background of the invention A number.of surgical procedures result in the formation of plumes of smoke or other gases. In particular, laser surgery and electrocautery surgery both result in the generation of smoke. It is now thought to be undesirable to vent the generated smoke from surgical sites to the atmosphere of the operating theatre due to occupational health and safety issues. In particular, the generated smoke has an unpleasant odour and may contain entrained particles. Furthermore, it is believed that there are some viruses that may be able to survive in the smoke plume (often called a diathermy plume) and it is clearly undesirable to have such particles and viruses exhausted into the atmosphere of the operating theatre where the operating staff are present. A further problem is caused by the smoke plume or diathermy plume obscuring the vision of the surgeon and other operating theatre staff.

In order to avoid venting of the smoke plume or diathermy plume to the atmosphere of the operating theatre, there have been proposed devices to capture and remove this smoke. Such devices invariably operate on suction or vacuum to capture the smoke close to the site of the operation and transport the smoke away from the site of the operation via conduits. Such devices may be connected 1to vacuum sources located remotely from the operating theatre (such as a piped vacuum system in a hospital).

Alternatively, such devices may be connected to vacuum sources located within the operating thea-tre. In such cases, the device typically includes one or more filters, such as charcoal filters, to remove undesirable components from the smoke plume of diathermy plume.

An example of such an apparatus is described in United States Patent No.

5,368,560, assigned to Medical Development Systems, Inc. This patent describes a 004414178 3 suction nozzle for attachment to a partial vacuum source for removing smoke and liquid from a surgical area during laser or electrocautery surgery. The nozzle includes a cylindrical inner tube fixedly and concentrically attached within a cylindrical outer tube, with the distal end of the inner tube extending forwardly of the distal end of the outer tube. A plurality of annularly spaced, radially extending connecting webs interconnect the outer and inner tubes together and define a respective plurality of discreet passageways through which the smoke and liquid are suctioned, in addition to the passageway of the inner tube. An auxiliary nozzle, in the form of a relatively long, thin nozzle, may be attached to the exposed, distal end of the inner tube for passage through a trocar cannula or the like during endoscopic procedures. A flow control knob is also provided for removable and rotatable attachment to the distal end of the outer tube for selectively controlling the fluid flow through the passageways between the connecting webs.

The rotatable flow control knob is used when the auxiliary nozzle is attached to the distal end of the inner tube for use in endoscopic procedures. In such use, all gaseous and liquid matter removal of the device of US 5,368,560 occurs through the inner tube.

Therefore, it is desirable to close off the passageways in the outer tube and the flow control knob is used to selectively close those passageways. Thus, the flow control knob permits selective adjustment of the amount of vacuum force occurring at the inner tube by closing off the outer passageways defined between the ilnner tube and the outer tube.

In this use of the device with the flow control knob attached, the outer passageways are not available for removal of gases or liquids from the site of the operations. Rather, as clearly set out in US 5,368,560, all gaseous and liquid matter removal occurs through the inner tube.

004414178 .4 Brief description of the invention Throughout this specification unless stated otherwise, where a document, act or item of knowledge is referred to or discussed, this reference or discussion is not an admission that the document, act or item of knowledge, or any combination thereof was part of the common general knowledge at the priority date.

In a first aspect, the present invention provides a device for removing gases or liquids or both from a surgical site, said device being connectible to a source of vacuum and including: a tube having a distal end, the tube having at least one opening at or near the distal end; and a moveable closure means for selectively altering the area of the at least one opening through which gases or liquids from the surgical site can pass, said closure means being fitted to the distal end of the tube, the closure means having at least one aperture so that movement of the attachment can selectively cover or uncover the at least one opening in the tube; the closure means being moveable between the closed position in which part of at least one opening is occluded by the attachment to reduce the area through which gases or liquids can pass and an open position in which said closure means does not occlude the opening.

In an embodiment, the closure means extends beyond the distal end of the tube and is provided with a sleeve fitted to the distal end of the tube, the sleeve having at least one aperture aligned with the opening in the tube, the closure means having at least one further aperture in fluid communication with an opening in the tube.

In another embodiment, the closure means is a sleeve and the tube is provided with an enlargement to prevent the sleeve from extending beyond the tip of the tube, the tip of the tube having one or more openings..

It is especially preferred that the device is arranged such that the closing means cannot be removed, in normal use, over the distal end of the device. The plurality of openings may include one or more openings located away from the tip of the distal end of 004414178 the device. Even more preferably, the one or more openings includes a plurality of openings extending away from the distal end of the device.

In the first aspect of the present invention, the closing means may include at least one opening which may comprise at least one slot extending away from the distal end of the device or a plurality of openings extending away from the distal end of the device.

The device of the first aspect may be provided as part of a hand held instrument which supplies vacuum to a surgical site or as an attachment to a vacuum supply instrument.

The devices of the first aspect of the invention may further include actuation means for controlling the position of the closing means. The actuation means may cause axial movement of the closing means, rotational movement of the closing means or any other movement of the closing means.

The device of the first aspect of the present invention is adapted for connection to a source of vacuum. To this end, the device may include a tube or conduit for connection to a source of vacuum or may be fitted to a conduit or tube connected to a source of vacuum. To minimise the undesirable components of a smoke plume of diathermy plume being discharged, the tube may be fitted with filtering means. The filtering means is suitably one or more charcoal filters.

In cases with both liquids and gases are to be removed from the surgical site, it has been found that gas filters can tend to become blocked by components of the liquid stream.

Accordingly, in a second aspect, the present invention provides an apparatus for removing gases or liquids or both from a surgical site, said device comprising a gas and liquid removal means for placement at or near a surgical site for removing gas or liquid or both from the surgical site, said gas and liquid removal means being connectable to a source of vacuum by conduit means, said conduit means including a first conduit for conveying gases removed from the surgical site and a second conduit for conveying liquid removed from the surgical site, and valve means for selectively enabling and disabling flow through the first conduit and the second conduit.

004414178 6 The first conduit preferably includes filter means for removing components of the gas stream from the gas removed from the surgical site.

The conduit means preferably comprises a first portion of conduit connectable to a source of vacuum, said first and second conduits being connected to the first portion of conduit. The first and second conduits suitably comprise a split tube. This enables easy handling of the device.

The valve means suitably comprises a first valve for selectively flow through the first conduit and a second valve for selectively controlling flow through the second conduit.

The valve means comprise a valve system commercially sold under the name LISS valve system. This system includes an inlet line that, in use, is connected to the device of the present invention. The valve system also includes two outlet ports that are connected to a source on sources of vacuum. The openings are selectively able to be opened or closed by the user. One opening allows the removal of liquids from the site of the operation which the other opening allows the removal of gases from the site of the operation. The conduit for removing gases is preferably fitted with a gas filter.

The second aspect of the invention may be used separately with a conventional suction nozzle, but it is preferably used in conjunction with the first aspect of the invention.

Brief description of the drawings Figure 1 shows a side schematic view of an apparatus in accordance with the first aspect of the present invention; Figure 2 shows a schematic view of the distal end of an embodiment of the first aspect of the present invention; Figure 3 shows the distal end of figure 2 with the component parts separated from each other; Figure 4 shows the component parts of an alternative embodiment of the distal end of a device in accordance with the first aspect of the present invention with the parts separated from each other; 004414178 7 Figure 5 shows the distal end of the device shown in figure 4 with the parts assembled together; Figure 6 shows a further embodiment'of the distal end of a device in accordance with the first aspect of the present invention; Figure 7 shows a schematic view of the distal end of a device in accordance with yet a further embodiment of the first aspect of the present invention; Figure 8 shows a cross-sectional view along line 8 to 8 of figure 2, with the holes in the uncovered position; Figure 9 shows a similar view to that shown in figure 8, but with the holes in the covered position; Figure 10 shows a schematic view of the distal end of a device in accordance with an embodiment of the second aspect of the invention with the component parts separated from each other; Figure 11 shows a side view of the apparatus of Figure 10 with the component parts assembled together; Figure 12 is an end view of the apparatus of Figure 11; Figure 13 shows a schematic side view of an alte:mative embodiment to the embodiment of Figure Figure 14 shows an end view of the apparatus of Figure 13; Figure 15 shows a schematic view of an embodiment in accordance with the second aspect of the present invention; Figure 16 shows a schematic view of an alternative embodiment in accordance with the second aspect of the invention; Figure 17 shows a further embodiment in accordance with the first or second aspect of the present invention; and Figure 18 shows a cross section taken along line 17-17 in Figure 17.

004414178 8 Detailed description of the drawings It will be appreciated that the attached drawings show preferred embodiments of the present invention and that the invention should not be considered to be limited solely to the features shown in those embodiments.

The device 10 of figure 1 is used for removing gases or liquids or both from the site of an operation. The device may by used in open surgery, or it may be used in endoscopic or laparoscopic surgery.

The device suitably comprises a wand or handle 12 having a distal end 14 and a proximal end 16. The proximal end 16 includes a connection means enabling the device to be connected to a conduit 18. Conduit 18 includes an in line filter 20, which is most suitably a charcoal filter. In line filter 20 is itself connected via a further conduit 22 to a source of vacuum (not shown).

The distal end 14 of the device 10 includes a plurality of holes 24, 26. Holes 24 extend along the device 10 from the distal end thereof In use: of the device, the holes 24 may be selectively covered, opened-or closed by use of a moveable closing means. In the preferred embodiment shown in figure 1, the plurality of openings 26 remain open, irrespective of the position of the moveable closing means. In use of the device, when the device is to be used to remove liquids from the surgical site, ihe closing means is used to close the plurality of openings 24. Thus, the vacuum applied to the device 10 causes suction only through holes 26, which acts to increase the suction through the holes. If the device is to be used to capture a diathermy plume or smoke plume, the closing means can be moved such that the plurality of openings 24 are opened. In this position, the openings 24 and 26 allow suction therethrough and thus the area of suction available for capturing the smoke plume or diathermy plume is significantly increased.by virtue of the holes 24 being opened.

Various embodiments of the distal end 14 of the device 10 shown in figure 1 are shown in figures 2 to 7. Referring initially to figures 2 and 3, the distal end 14 includes a tube 30 that forms an extension of wand or handle 12. A closing means 32, in the form of a rotatable tip, is mounted over the end of the tube 30. Closing means 32 includes a 004414178 9 plurality of openings 26 and another plurality of openings 24A. As best seen in figure 3, tube 30 also includes a plurality of openings 24.

The openings 24 and 24A are arranged such that when the closing means 32 is positioned over the end of tube 30, as shown in figure 2, the plurality of openings 24A on the closing means can be brought into alignment with the plurality of openings 24 on the tube An alternative embodiment of the distal end 14 of the device 10 is shown in, figures 4 and 5. In figure 4, the distal end includes a tube 30 that has an enlargement 34 formed at the end thereof. Enlargement 34 includes plurality of openings 26. The tube also includes the plurality of openings 24.

The embodiment shown in figures 4 and 5 also includes a sleeve 36 that fits over tube 30. Sleeve 36 includes a plurality of openings 24A. The plurality of openings 24A are positioned such that when sleeve 36 is fitted to tube 30, the openings 24A can align with the openings 24 on tube The advantage of the embodiment shown in figure 4 and 5 is that sleeve 36 cannot be removed over the distal tip of the device 10 during normal use of the device.

Therefore, the risk that the closing means may fall off during use in surgery is largely overcome with the embodiment shown in figures 4 and Figure 6 shows a further alternative embodiment of the distal tip of the device of the present invention. In the embodiment shown in figure 6, the tube 30 has an attachment 38 fitted thereto. Attachment 38 is essentially identical to closing means 32 shown in figures 2 and 3. However, the embodiment shown in figure 6 differs from the embodiment shown in figures 2 and 3 in that tube 30 is not provided with a plurality of openings 24. Rather, the plurality of openings 24 are provided on attachment 38. A sleeve 36 that is essentially identical to sleeve-36 shown in figures 4 and 5 is mounted for rotational movement over the shank of attachment 38. Sleeve 36 includes a plurality of openings 24A that can be brought into alignment with the plurality of openings 24 on attachment 38.

004414178 Figure 7 shows an embodiment that is generally similar to that shown in figures 2 and 3 except that the distal tip of tube 30 is provided with a barbed ending or flanged ending 40 to assist in retaining the closing means 32 thereon. This embodiment also assists in minimising the chances of the closing means being inadvertently removed from the device during normal use of the device.

Figures 8 and 9 show cross-sectional views along line 8 to 8 in figure 2. Figures 8 and 9 show the device in the open position and the closed position, respectively.

As can be seen from figures 8 and 9, the inner tube 30 includes openings 24 spaced around the periphery thereof. In the embodiments shown in figures 8 and 9, the tube 30 includes four series of openings 24 about its periphery. Similarly, closing means 32 includes corresponding pluralities of openings 24A positioned about its periphery. As shown in figure 8, when the openings 24A are brought into alignment with the openings 24, a flow passage for suction throughthe walls of the distal tip 14 of the device 10 is established.

As shown in figure 9, when the openings 24A in closing means 32 are moved out of alignment with openings 24 in tube 30, the openings 24 in tube 30 are closed, covered or blocked and therefore there is no path for suction provided through openings 24. Thus, all suction through the distal tip occurs through openings 26.

It will be understood that Figures 8 and 9 are drawn at an exaggerated scale for clarity. In use, the closing means will sit in close contact with the device.

In another embodiment of the present invention, as shown in figures 10 to 12, the plurality of openings 24, 26 are replaced by one or more slots. With reference to figures to 12, which show an embodiment that generally corresponds to the embodiment shown in figures 4 and 5, the tube 30 having an enlargement 34 also includes a slot 42.

The closing means, the form of sleeve 36 also includes a slot 44. When the sleeve 36 is mounted onto tube 30, the slot 44 can be brought into alignent with a part of slot 42 to thereby fully open slot 42. When sleeve 36 is rotated such that slot 44 is out of alignment with slot 42, part of slot 42 is closed, thereby reducing the effective length or area of slot 42 available to provide a suction flow path.

004414178 11 As shown in -figure 12, the tube 30 may be provided with more than one slot 42.

Further, the at least one slot 42 may extend at least partly around the enlarged portion 34 of tube In the embodiment shown in figures 13 and 14, tube 30 is provided with two slots 46, 48. Slot 48 in the enlargement 34 of tube 30 is positioned at the very distal tip of enlargement 34, which assists in placing the device for best removal of liquid from the surgical site.

Figure 15 shows an embodiment of the second aspect of the present invention.

The device of figure 15 includes the device 10 of figure 1 for removing gas or liquid or both from a surgical site. The device 10 includes a distal tip 14, which may be as shown in any of the embodiments described with reference to figures 2 to 14.

The proximal end 16 of device 10 is fitted to a valve system 50. The valve system includes a first valve 52 and a second valve 54. Valve 52 is actuated byactuation means 53 to selectively open and close the valve. Similarly valve 54 is actuated by actuation means 55 to selectively open and close second valve 54. Valve 52, when opened, allows full communication with a first port 56 that is connected to first conduit 58. First conduit 58 is fitted with an in line filter 60, which is preferably a charcoal filter.

Second valve 54 controls the fluid communication to a second port 62. Second port 62 is in full communication with a second conduit 64.

First conduit 58 and second conduit 64 are preferably formed as a split tube in which first conduit 58 and second conduit 64 are connected -together via a thin intermediate web.

The proximal end of first conduit 58 and second conduit 64 are connected to a Y piece 66, which Y piece is connected to a further conduit 68 that, in turn is connected to a source of vacuum, such as a vacuum pump.

In use of the apparatus shown in Figure 15, the distal end 14 of wand 12 is positioned near the site of the operation. To remove fluids,, such as blood or irrigation saline, from the site of the operation, second valve 54 is operated by valve actuation means 55 to place the source of suction into fluid communication with wand 12. This 004414178 12 causes suction to remove liquids through second conduit 64. To stop the removal of liquids, valve actuation means 55 is released, which closes seccond valve 54.

To remove smoke or gases from the site of the operation, first valve 52 is opened by valve actuation means 53. This causes the smoke or gases to be sucked into and through first conduit 58. To increase the area available for removing smoke or gases at the distal end 14 of wand 12, closing means 32 is operated to open the apertures in the distal end. For removal of liquids it is preferred that the closing means is placed in a closed position to close some of the openings in the distal end of the ward.

In a further alternative embodiment shown in Figure 16, the device 10 of the present invention is connected to conduit 70. Conduit 70 has a two-way valve 72. One outlet of the two-way valve is connected to conduit 74, which provides a flow path for liquids removed from the site of the operation. The other outlet of the two-way valve is connected to a conduit 76 having an in-line gas filter 78. The outlet conduit 80 from gas filter 78 subsequently re-connects with conduit 74. Extension 82 of the conduit is connected to a source of vacuum. In operation of the device of Figure 16, two way valve 72 is operated to enable flow through conduit 74 when removing liquids and to enable flow through conduit 76 when removing smoke or gases.

It will be appreciated by those skilled in the art, that the invention described herein may be subject to modifications and variations other than those specifically described. For example, the number of openings in the distal tip of the device may be varied. The plurality of openings may be replaced by a slot or slots. The closing means may be moved by rotating it around the distal end of the device or by moving it axially along the distal end of the device. The valve system shown in figure 15 may be of different construction and detail to the specific embodiment given in figure 15. The attachment or closing means may be made from any suitable material. A thermoplastic' rubber or thermoplastic elastomer is preferred. The ward is suitably made from a rigid plastic material.

Turning to Figures 17 and 18, which show a further embodiment of the first or second aspect of the present invention, the device of Figure 17 is similar to that shown in Figure 1 and, where appropriate, similar reference numerals have been used to denote 004414178 13 similar features. In particular, the device of Figure 17 comprises a wand or handle 12 having a distal end 14 and a proximal end 16. The proximal end 16 includes a connection means enabling the device to be connected to a conduit 18. Conduit 18 may be connected to a source of vacuum (not shown)..

The distal end 14 of the device 10 includes a plurality of holes 24, 26. Holes 24 extend along the device 10 from the distal end thereof. In use of the device, the holes 24 may be selectively covered, opened or closed by use of amoveable closing means. In use of the device, when the device is to be used to remove liquids from the surgical site, the closing means is used to close the plurality of openings 24. Thus, the vacuum applied to the device 10 causes suction only through holes 26, which acts to increase the suction through the holes. If the device is to be used to capture a diathermy plume or smoke plume, the closing means can be moved such that the plurality of openings 24 are opened. In this position, the openings 24 and 26 allow suction therethrough and thus the area of suction available for capturing the smoke plume or diathermy plume is significantly increased by virtue of the holes 24 being opened.

The closing means in Figure 17 comprises a slidable sleeve or cover 100. Slidable sleeve or cover 100 is hollow and dimensioned to fit over the distal end 14 of wand 12.

Slidable sleeve or cover 100 is able to move in an axial direction along the wand or handle 12, as indicated by arrows 102,104.

In order to move slidable sleeve or cover 100 an actuation mechanism is provided. The actuation mechanism includes a finger slide mechanism 106 mounted to wand 12. A push rod 108 extends from the finger slide mechanism 106 to the slidable sleeve or cover 100 The push rod 108 may be retained in place by suitable guides 110.

As best shown in Figure 18, guides 110 comprise arms 112, 114 that extend around the wand 12 to grip the wand and be retained in place on the wand. The guides 110 also include a guide conduit 116 to retain the push rod 108 therein.

In order to operate the slidable sleeve or cover 100, the surgeon pulls back or slides back the finger slide 106. This causes the push rod 108 to also move rearwardly and away from the distal end 14 of the wand 12, thereby causing the slidable sleeve or cover 100 to move axially away from the distal end 14. This uncovers or opens the 004414178 14 openings 24. To cover the openings 24, the surgeon moves the finger slide 106 towards the distal end 14, which in turn moves the slidable sleeve or cover 100 back over the openings 24.

The push rod may be made from a plastics material, such as polypropylene. The push rod may include a reinforcing ridge. Other means to move the slidable sleeve may also be provided, such as a cable or wire, which may interact with a biasing means to move the sleeve, or a flexible plastic cord. The push rod guides 110 may be made from a suitable plastics material, such as PVC, polyethylene or polypropylene. This list is not exhaustive. The sleeve may be made from a thermoplastic rubber or a thermoplastic elastomer.

The embodiment shown in Figure 17 provides a device in which control of the closing means is provided by an actuation mechanism that is located near the gripping portion of the wand 12 and can be conveniently operated by the surgeon. The present invention extends to cover all actuation mechanisms that afford convenient control over the positioning of the closing means, whether those actuation means cause axial movement, rotational movement or any other movement of the closing means.

It will be understood that the invention disclosed and defined herein extends to all alternative combinations of two or more of the individual features mentioned or evident from the text or drawings. All of these different combinations constitute various alternative aspects of the invention

Claims (4)

1. A device for removing gases or liquids or both from a surgical site, said device being connectible to a source of vacuum and including: a tube having a distal end, the tube having at least one opening at or near the distal end; and a moveable closure means -for selectively altering the area of the at least one opening through which gases or liquids from the surgical site can pass, said closure means being fitted to the distal end of the tube, the closure means -having at least one aperture so that movement of the attachment can selectively cover or uncover the at least one opening in the tube; the closure means being moveable between the closed position in which part of at least one opening is occluded by the attachment to reduce the area through which gases or liquids can pass and an open position in which said closure means does not occlude the opening.

2. The device of claim 1, wherein the closure means includes a sleeve having at least one aperture aligned with an opening in the tube, the tube is provided with an enlargement to prevent the sleeve from extending beyond the tip of the tube, the tip of the tube having one or more openings.

3. The device of claim 1 wherein the end of the closure means extends beyond the distal end of the tube and is provided with a sleeve having at least one aperture aligned with the opening in the tube, the closure means having at least one further aperture in fluid communication with an opening in the tube.

4. The device of any one of the preceding claims, further including an actuation means for controlling the position of the closure means. 004414178 16 the device of claim 4, wherein the actuation means causes axial or rotational movement of the closure means. 23 December 2003 By Freehills Carter Smith Beadle Registered Patent Attorneys for the Applicant Fairmont Medical Products Pty Ltd