GB2597782A

GB2597782A - A surgical instrument

Info

Publication number: GB2597782A
Application number: GB2012229.7A
Authority: GB
Inventors: Runnalls Matthew; Neale John; Mcaleer Liam
Original assignee: Gyrus Medical Ltd
Current assignee: Gyrus Medical Ltd
Priority date: 2020-08-06
Filing date: 2020-08-06
Publication date: 2022-02-09
Anticipated expiration: 2040-08-06
Also published as: GB202012229D0; GB2597782B

Abstract

A surgical instrument 3 comprising an end effector 24 mounted on the end of an elongate shaft 22 extending from a handle 20, the end effector comprising a rotary shaver arrangement providing an open-ended tubular element with a rotating cutting potion. The instrument is further arranged to temporarily receive an RF electrosurgical device 12 during surgery so as to provide tissue coagulation or vaporising. The electrosurgical device comprises one or more electrodes 44 mounted on the end of an elongate member 42. The surgical instrument comprises an entry port (32, Fig 3) that allows the electrosurgical device to be threaded along the elongate shaft of the surgical instrument and through the open end of the tubular portion of the rotary shaver. The entry port is preferably self-sealing and provided on a moulded component 30 mounted on the handle. The moulded component may also provide a second entry port 38 for connection to a suction port. The surgical instrument may be provided in a system alongside the electrosurgical apparatus, electrosurgical generator and suction source.

Description

A SURGICAL INSTRUMENT

Technical Field

Embodiments of the present invention described herein relate to a surgical instrument, and in particular to a surgical instrument for cutting tissue arranged to receive an electrosurgical device during use for providing a tissue vaporisation, coagulation or sealing effect.

Background to the Invention and Prior Art

Surgical instruments used in laparoscopic surgical procedures where access to the surgical site is restricted to a narrow passage, for example, in minimally invasive "keyhole" surgeries, often comprise an end effector disposed on the end of an elongate shaft, the end effector comprising a mechanical cutting portion such as a rotary blade, which works to remove tissue as it rotates. Such devices may have many different configurations, but typically, include an open ended tubular component with a rotating cutting blade. For existing laparoscopic shavers, if bleeding occurs, they must be removed from the surgical site and replaced with a bipolar radio frequency (RE) electrosurgical device to coagulate and seal the tissue. This process of switching between the mechanical instrument and the bipolar electrosurgical device is time consuming, thereby increasing the length of the surgery.

Some known instruments incorporate both a mechanical cutting portion and a bipolar electrosurgical portion into the same end effector so as to provide a quick transition between the tissue shaving action and the bipolar sealing. However, this results in instruments having a large diameter that is unsuitable for some key-hole surgical procedures.

Summary ol the Invention

Embodiments of the present invention provide a surgical instrument comprising an end effector mounted on the end of an elongate shaft extending from the handle. The end effector comprises a mechanical cutting portion in the form of an open ended tubular component comprising a rotatable cutting blade that rotates when supplied with a direct current to provide a tissue shaving action. For example, the end effector may comprise an outer tubular member that remains static, with a rotatable cylindrical element co-axially arranged within the outer tubular member. Both the outer tubular member and the rotatable element have a circumferential cut-out portion, with one or both of the cut-put portions having a sharpened edge, which in use create a scissor like cutting action as the cylindrical element rotates. The instrument is further arranged to temporarily receive an RF electrosurgical device during surgery so as to provide an electrosurgical tissue coagulation or tissue vaporising action. The electrosurgical device comprises one or more electrodes mounted on the end of a needle-like elongate member, the elongate member of the electrosurgical device having a smaller diameter than the elongate shaft of the surgical instrument, such that the member can fit inside the elongate shaft. The surgical instrument comprises an entry port that allows the electrosurgical device to be threaded along the elongate shaft of the surgical instrument and through the open end of the mechanical shaver. The entry port preferably comprises a self-sealing mechanism, for example, using an clastomeric material, to form a seal around the electrosurgical device whilst inserted to the surgical instrument. The operator can then activate an RF power source to supply an RF electrosurgical signal to the electrode(s). Once the operator has finished coagulating or vaporising the tissue with the electrode(s), the electrosurgical device can be quickly removed and the mechanical shaving of the tissue can be resumed. As such, a quick transition between the mechanical and electrosurgical functions can be made without needing to remove the shaving device from the surgical site, whilst at the same time maintaining the small diameter needed for laparoscopic surgeries.

A first aspect of the present invention provides a surgical instrument, comprising: a handle, an elongate shaft extending from a distal end the handle, and an end effector positioned at the distal end of the elongate shaft, the end effector comprising a rotary shaver arrangement, having a tubular element with a rotating cutting portion that when in use is able to cut tissue located in an operative cutting direction, the tubular element having an open distal end; wherein the surgical instrument is configured to receive an electrode assembly of an electrosurgical device, the electrode assembly comprising at least one active electrode disposed on a distal end of an elongate member, wherein the surgical instrument comprises a first entry port for receiving the electrode assembly, to thereby allow the electrode assembly to be advanced along elongate shaft such that the one or more electrodes protrude from the open distal end of the tubular clement.

As such, an electrosurgical device may be inserted to the surgical instrument during surgery so as to provide an electrosurgical function without needing to remove the whole instrument from the surgical site. Likewise, the electrosurgical instrument can be quickly removed on completion of the electrosurgical functions, and the mechanical shaving function can be resumed immediately. As described above, this provides a quick transition between the mechanical and electrosurgical functions without needing to remove the shaving device from the surgical site, whilst at the same time maintaining the small shaft diameter needed for laparoscopic surgeries.

The surgical instrument may further comprise a moulded component mounted on a proximal end of the handle, wherein the moulded component comprises the first entry port.

The first entry port may comprise a self-sealing mechanism, for example, the self-sealing mechanism may comprises a self-sealing passage. As such, when the electrosurgical device is inserted to the first entry port, the self-sealing passage deforms to allow the electrode assembly to pass through and then seals around the elongate member of the electrode assembly once fully in place. Once the electrosurgical device has been removed, the self-sealing passage collapses to seal the first entry port.

Preferably, the self-sealing mechanism comprises an elastomeric material. For example, the elastomeric material may be one of: thermoplastic polyurethane (TPU). Nitrile, and Silicone.

The moulded component may further comprise an exit port, the exit port being aligned with the elongate shaft. That is to say, the exit port of the moulded component is in line with the opening of the elongate shaft to ensure that elongate member of electrode assembly is directed into the shaft.

In some arrangements, the handle mat comprise an internal guide channel extending from the moulded component to the elongate shaft.

The moulded component may further comprise a second entry port for connection to a suction source.

A further aspect of the present invention provides an electrosurgical apparatus, comprising: a surgical instrument as described above; and an electrosurgical device, comprising: a hand-piece; and an electrode assembly, distal to the hand piece, wherein the electrode assembly comprises at least one active electrode disposed on a distal end of an elongate member, wherein the electrode assembly is configured to be inserted to the surgical instrument via the first entry port and advanced along elongate shaft of the surgical instrument such that the one or more electrodes protrude from the open distal end of the tubular element.

Yet a further aspect of the present invention provides an electrosurgical system, comprising: an RE electrosurgical generator; a suction source; and an electrosurgical apparatus as described above. In some arrangements, the generator may comprise: (i) a source of radio frequency (RE) power; (ii) two or more electrical connections for connecting the generator to the electrosurgical apparatus; and (iii) a controller operable to cause the generator to supply power to the two or more connections; and (iv) switching means operable to send signals to the controller to activate the source of RF power, wherein the switching means are operable to send a first signal to the controller to supply a direct current to the surgical instrument via a first connection, and at least a second signal to the controller to supply an RE electrosurgical signal to the electrosurgical device via a second connection.

The RE electrosurgical signal may comprise an RE vaporisation waveform or an RE coagulation waveform. Alternatively, the RE electrosurgical signal may be a blended RE signal comprising an RE vaporisation waveform and an RE coagulation waveform.

Brief Description of the Drawings

Embodiments of the invention will now be further described by way of example only and with reference to the accompanying drawings, wherein like reference numerals refer to like parts, and wherein: Figure 1 is a schematic diagram of an electrosurgical apparatus including a surgical instrument and an electrosurgical device according to an embodiment of the present invention; Figure 2 is a side view of a surgical instrument and an electrosurgical device according to an embodiment of the present invention; Figure 3 is perspective view of a component of the surgical instrument of Figure 2; Figure 4 is a cross-sectional view further illustrating a component of the surgical instrument according to the present invention.

Description of the Embodiments

Referring to the drawings. Figure 1 shows electrosurgical apparatus including an electrosurgical generator 1 having an output socket 2 for providing a direct current output, via connection cords 4, 4a, to a surgical instrument 3 having an end effector configured to provide a mechanical shaving function, as well as a radio frequency (RE) output, via connection cords 4, 4b, to a bipolar electrosurgical device 12 having an end effector configured to provide electrosurgical coagulating and/or ablating (i.e. tissue vaporisation) functions. In this respect, the generator 1 also comprises control circuitry (software plus switching relays) constituting selection means for changing which of the output connections become -live". Activation of the generator 1 may be performed from the instrument 3 or electrosurgical device 12 via a handswitch (not shown), or by means of a footswitch unit 5 connected separately to the rear of the generator 1 by a footswitch connection cord 6. In the illustrated embodiment, the footswitch unit 5 has three footswitches 5a, 5b and Sc for selecting a mechanical shaving mode, or an electrosurgical coagulating or vaporisation mode of the generator 1 respectively. For example, each pedal 5a, 5b, 5c can be depressed individually to activate its assigned function in isolation by sending a signal to the generator 1 to activate the mechanical shaving function of the surgical instrument 3, for example, by supplying a direct current to drive componentry for a shaver, or to start sending the relevant RF signal(s) to activate the electrosurgical functions of the electrosurgical device 12. The generator front panel has push buttons 7a and 7b for respectively setting vaporisation or coagulation power levels, which are indicated in a display 8. Push buttons 9 are also provided as an alternative means for selection between the mechanical shaving, vaporisation and coagulation modes.

The surgical instrument 3 also has irrigation and suction tubes 11 which are connected to an irrigation fluid and suction source 10.

Figure 2 shows the surgical instrument 3 and electrosurgical device 12 in more detail.

The surgical instrument 3 comprises a handle 20 comprising an elongate shaft 22 extending from its distal end. The elongate shaft 22 comprises an end effector 24 in the form of a mechanical shaver, the mechanical shaver 24 comprising an open ended tubular component with a rotating blade arranged to be driven by drive componentry (not shown) within the handle 20. For example, the mechanical shaver 24 may comprise an outer tubular member (not shown) that remains static, with a rotatable cylindrical element (not shown) co-axially arranged within the outer member. Both the outer tubular member and the rotatable element have a circumferential cut-out portion, with one or both of the cut-put portions having a sharpened edge, which in use create a scissor like cutting action as the cylindrical element rotates. The handle 20 comprises an electrical port 26 for connecting the drive componentry of the mechanical shaver 24 to the generator 1 via connection cord 4a, wherein the direct current may be activated using a handswitch 28 on the handle 20, or by using the footswitch 5 or push buttons 9 on the generator 1, as described above.

The electrosurgical device 12 comprises an electrode assembly 40 having a thin, elongate "needle-like" member 42 with one or more electrodes 44 disposed on its distal end. The electrode(s) 44 may have any suitable configuration for providing a bipolar electrosurgical coagulation and/or vaporisation function. The electrosurgical device 12 also comprises a handle 46 that connects the electrode(s) 44 to the generator 1 via connection cord 4b, wherein the RF power supply may be activated using a handswitch 48 on the handle 46, or by using the footswitch 5 or push buttons 9 on the generator 1, as described above. In this respect, the user may operate the generator 1 to output a bipolar RF electrosurgical signal comprising an RF coagulation waveform, an RF vaporisation waveform, or a blended RF signal comprising both the RF coagulation and vaporisation waveforms.

The surgical instrument 3 further comprises a moulded component 30 that is configured to receive the electrosurgical device 12, as shown in further detail in Figure 3. The moulded component 30 comprises a self-sealing entry port 32 that is configured to receive the electrosurgical device 12. The electrode assembly 40 can be threaded through the moulded component 30 via the entry port 32 and along the elongate shaft 22 of the instrument 3, until the electrode(s) 44 protrude through an opening of the mechanical shaver 24. In this respect, the mechanical shaver 24 may arranged so that the electrode(s) 44 pass through the circumferential cut-out portions of the outer tubular member and the rotatable element, in which case, the outer tubular member and rotatable element will need to be mechanically or electrically aligned. Alternatively, the electrode(s) may pass through distal-most opening of the mechanical shaver 24, whereby the electrode(s) are free to pass through irrespective of blade position. It will also be appreciated that the elongate shaft 22 may extend substantially into the handle 20 such that it reaches the exit port 34 of the moulded component 30. Alternatively, the handle 20 may comprise some other internal track or channel for guiding the electrode assembly 40 from the exit port 34 to the elongate shaft 22. The moulded component 30 may be assembled via a threaded portion 36 that can be screwed into a corresponding opening on the handle 20 to thereby secure the moulded component 30.

The moulded component 30 also comprises a suction port 34 for connecting the instrument 3 to the suction source 10 via the irrigation and suction tubes 11, such that fluid may be delivered to and from the distal end of the instrument 3 via the elongate shaft 22. It will however be appreciated that the suction source 10 may be connected in some other suitable way Figure 4 illustrates an example of the self-sealing mechanism that may be used in the moulded component 30 described above. Figure 4 shows an example moulded component 50 comprising a proximal entry port 52 for receiving the electrode assembly 40, and a distal exit port 54 that will be coupled to the handle 20 in some suitable, as discussed above. The entry port 52 comprises a self-sealing passage 56 formed of a deformable material, for example, thermoplastic polyurethane (TPU), Nitrile, Silicone, or some other deformable and sterilisable elastic material. As the electrode assembly 40 is inserted to the entry port 52, the self-sealing passage 56 deforms to allow the electrode assembly 40 to pass through and then seals around the elongate member 42 of the electrode assembly 40 once fully in place. Once the electrode assembly 50 has been removed from the instrument 3, the self-sealing passage 56 will collapse and seal the entry port 52.

Whilst the moulded component 50 is shown without a suction port for connecting the instrument 3 to the suction source, it will be appreciated that moulded component. 50 may be adapted to include a suction port, for example, in the region of the distal exit port 54.

In use, whilst the electrosurgical device 12 is removed, the user activates the mechanical shaving function of the generator 1 so as to supply a direct current to the drive componentry of the mechanical shaver 24. When an electrosurgical coagulation or vaporising function is required, the user deactivates the direct current supply, and inserts the electrosurgical device 12, as described above. Once fully installed, the operator than activates the RF power supply so as to start sending the relevant RF signal(s) to activate the electrosurgical functions of the electrode(s) 44. Once completed, the RF power supply is deactivated and the electrosurgical device 12 removed, so that the mechanical shaving function of the instrument 3 may be resumed. As such, a quick transition between the mechanical and electrosurgical functions can be made without needing to remove the surgical instrument 3 from the surgical site, whilst at the same time maintaining the small diameter needed for laparoscopic surgeries.

Various modifications whether by way of addition, deletion, or substitution of features 25 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.

Claims

Claims 1. A surgical instrument, comprising: a handle, an elongate shaft extending from a distal end the handle, and an end effector positioned at the distal end of the elongate shaft, the end effector comprising a rotary shaver arrangement, having a tubular element with a rotating cutting portion that when in use is able to cut tissue located in an operative cutting direction, the tubular element having an open distal end; wherein the surgical instrument is configured to receive an electrode assembly of an electrosurgical device, the electrode assembly comprising at least one active electrode disposed on a distal end of an elongate member, wherein the surgical instalment comprises a first entry port for receiving the electrode assembly, to thereby allow the electrode assembly to be advanced along elongate shaft such that the one or more electrodes protrude from the open distal end of the tubular element.
2. A surgical instrument according to claim 1, further comprising a moulded component mounted on a proximal end of the handle, wherein the moulded component comprises the first entry port.
3. A surgical instrument according to claim 2, wherein the first entry port comprises a self-sealing mechanism.
4. A surgical instrument according to claim 3, wherein the self-sealing mechanism comprises a self-sealing passage.
5. A surgical instrument according to claims 3 or 4, wherein the self-sealing mechanism comprises an elastomeric material.
6. A surgical instrument according to claim 5, wherein the elastomeric material is one of: thermoplastic polyurethane (TPU), Nitrile, and Silicone.
7. A surgical instrument according to claims 2 to 6. wherein the moulded component further comprises an exit port, the exit port being aligned with the elongate shaft.
8. A surgical instrument according to claims 2 to 7, wherein the handle comprises an internal guide channel extending from the moulded component to the elongate shaft.
9. A surgical instrument according to claims 2 to 8, wherein the moulded component further comprises a second entry port for connection to a suction source.
10. An electrosurgical apparatus, comprising: a surgical instrument according to claims 1 to 9; and an electrosurgical device, comprising: a hand-piece; and an electrode assembly, distal to the hand piece, wherein the electrode assembly comprises at least one active electrode disposed on a distal end of an elongate member, wherein the electrode assembly is configured to be inserted to the surgical instrument via the first entry port and advanced along elongate shaft of the surgical instrument such that the one or more electrodes protrude from the open distal end of the tubular element.
1 1. An electrosurgical system, comprising: an RE electrosurgical generator; a suction source; and an electrosurgical apparatus according to claim 10.
12. An electrosurgical system according to claim 11, wherein the generator comprises: (i) a source of radio frequency (RE) power; (ii) two or more electrical connections for connecting the generator to the electrosurgical apparatus; and (iii) a controller operable to cause the generator to supply power to the two or more connections; and (iv) switching means operable to send signals to the controller to activate the source of RF power, wherein the switching means are operable to send a first signal to the controller to supply a direct current to the surgical instrument via a first connection, and at least a second signal to the controller to supply an RF electrosurgical signal to the electrosurgical device via a second connection.
13. An electrosurgical system according to claim 12, wherein the RF electrosurgical signal comprises an RF vaporisation waveform or an RF coagulation waveform.
14. An electrosurgical system according to claim 12, wherein the RF electrosurgical signal is a blended RF signal comprising an RF vaporisation waveform and an RF coagulation waveform