Technical Field

The present invention relates to a device, and in particular, to a device for specimen or tissue retrieval during a surgical procedure such as, for example, laparoscopic surgery, or the like.

Background of the Invention

The following references to and descriptions of prior proposals or products are not intended to be and are not to be construed as, statements or admissions of common general knowledge in the art. In particular, the following prior art discussion does not relate to what is commonly or well known by the person skilled in the art, but assists in the understanding of the inventive step of the present invention of which the identification of pertinent prior art proposals is but one part.

During surgery, there is often the need to safely secure and retrieve a biological specimen from a patient. For example, during laparoscopic cholecystectomy, which includes laparoscopic removal of a patient’s gallbladder, devices are typically used instead of manual removal of the gallbladder by hand in order to mitigate the risk of any accidental stone or specimen spillage into the peritoneal cavity of the patient. However, mostly these devices are difficult to manoeuvre and often require the use of two hands to safely retrieve the specimen.

The present invention seeks to provide a device for retrieving a specimen which may ameliorate the foregoing shortcomings and disadvantages or which will at least provide a useful alternative. Summary of the Invention

According to one aspect of the invention, there is provided herein a device for retrieving a specimen, the device including: (a) a shaft member, the shaft member having: (i) an external shaft; (ii) an internal shaft, the internal shaft being configured to be moveable within the external shaft; (iii) a handle-end; and, (iv) a specimen end, the specimen end formed opposing the handle end; (b) a specimen retrieval means operatively connected to the shaft member at the specimen end; and, (c) a handle means connected to the shaft member at the handle end, the handle means being at least partly moveable between an undeployed state and a deployed state to retrieve the specimen.

According to another aspect, there is provided herein a device for retrieving a specimen during a surgical procedure, the device including: a shaft assembly having: an external shaft; an internal shaft, the internal shaft being configured to be moveable longitudinally within the external shaft; a handle-end; and, a specimen end, formed opposing the handle end; a specimen retrieval member operatively connected to the shaft member at the specimen end; and, a handle means connected to the shaft member at the handle end, the handle means being at least partly moveable between an undeployed state and a deployed state to move the internal shaft with respect to the external shaft for retrieving the specimen.

According to aspect, the internal shaft has a different cross-section to the external shaft.

According to one example, the internal shaft has a square or rectangular cross-section and the external shaft has a round or circular cross-section.

In yet a further example, the handle means includes a first handle and a second handle.

In yet another form, the first handle is attached to the external shaft and the second handle is attached to the internal shaft. According to another example, the handle means includes at least one keyed portion, the at least one keyed portion being configured to limit/prevent rotational movement between the internal shaft and the external shaft. According to another example, the first handle includes a first keyed portion to limit/prevent rotational movement of the internal shaft with respect to the external shaft.

In yet another form, the first handle includes a first channel for receiving the external shaft and the internal shaft, and wherein the first channel includes one or more narrowed sections, the narrowed sections being formed to key or lock the internal shaft from rotational movement with respect to the external shaft.

In yet another example, the second handle includes a second keyed portion to limit/prevent rotational movement of the internal shaft with respect to the external shaft.

According to another example, the second handle includes a second channel for receiving the internal shaft, the second channel being formed to key or lock the internal shaft from rotational movement with respect to the external shaft. According to another aspect, the first handle is a double-ring handle and the second handle is a single-ring handle.

In another form, the single-ring handle is configured to rest between each ring of the double-ring handle when in the deployed state.

In yet another form, in the undeployed state, the first handle is spaced-apart from the second handle such that the handle means is configured for one- handed deployment of the device.

According to another aspect, the device further includes an adapting member connected to the internal shaft at a first end of the adapting member and connected to the specimen retrieval means at a second end of the adapting member, wherein the adapting member is configured to seal a space between the internal shaft and the external shaft. In one example, the adapting member includes an O-ring placed at or near a centre of the adapting member to assist in sealing the space between the internal shaft and the external shaft.

According to another example, the adapting member includes one or more legs at the first end, the one or more legs being configured to hold the adapting member onto the internal shaft.

In a further example, the device includes a sealer, such as ball-shaped or substantially spherical sealer at the second end of the adapting member, to further assist in sealing the internal shaft. According to another example, the adapting member is operatively connected to one or more prongs at the second end.

In yet another form, the one or more prongs are configured to hold a specimen retrieval bag or container.

According to another example, rotation of the handle means rotates the one or more prongs. That is, according to this specific example, applying rotation to the handle means can rotate the rest of the device, such that rotation of the various parts of the device are aligned.

According to another aspect, there is provided herein a shaft assembly for a device for retrieving a specimen in a surgical procedure, the shaft assembly having an external shaft and an internal shaft, the internal shaft being configured to move longitudinally within the external shaft between an undeployed state and a deployed state.

According to one example, the device includes a first handle operatively connected to the external shaft and a second handle operatively connected to the internal shaft wherein longitudinal movement of the internal shaft with respect to the external shaft occurs by depressing or pushing the second handle towards the first handle or by moving the first handle and second handle towards/with respect to each other. In one example, the first handle includes two rings/is a double-ringed handle and the second handle is a single-ring handle. Thus, for example, depression of the second handle towards the first handle can occur through placement of a user’s thumb in the second handle and the user’s forefinger and middle finger (typically of the same hand) in corresponding rings of the first handle, thereby allowing for one-handed deployment of the device.

Accordingly, it will be appreciated by persons skilled in the art that the device described herein can be used as a specimen retrieval device where movement of the device between undeployed and deployed states is mechanically stable and easy to use, whilst internally the shaft means can be sealed to limit/prevent fluids escaping from a patient’s body and through the device.

It will be appreciated by persons skilled in the art that any combination of features, examples, or aspects of the device described herein is possible and is not limited to the specific combinations outlined above.

Brief Description of the Drawings

The invention may be better understood from the following non-limiting description of a preferred embodiment, in which:

Figure 1 is an exploded view of an example device in accordance with one aspect of the present invention;

Figure 2 is a side view of the example device of Figure 1, in an undeployed state;

Figure 3 is a side view of the example device of Figure 1 , in a deployed state; Figure 4 is a side view of an example of an internal shaft assembly of the device of Figure 1 ;

Figure 5 is a perspective view of an example of an adapting member/prong mount with prongs of the device of Figure 1 ;

Figure 6 is a perspective view of the adapting member and prongs of Figure 5, further including a string member and being attached/connected to an internal shaft of the device of Figure 1 ;

Figure 7 is a perspective view of an example adapting member/prong mount of the device of Figure 1 ;

Figure 8 is a perspective view of the adapting member of Figure 7, further including a sealing member;

Figure 9 is a perspective view of the adapting member of Figure 7 being attached/connected to an internal shaft member of the device as described herein;

Figure 10 is a perspective view of the adapting member of Figure 7 being attached/connected to prongs;

Figure 11 is a perspective view of an example of the adapting member of Figure 7, together with a sealing member and further including a string member;

Figure 12 is a perspective view of the example of Figure 11, further including prongs attached/connected to the adapting member, showing string and seals;

Figure 13 is a perspective view of an example string assembly for use with/included in the device described herein;

Figure 14 is a perspective view of an example of a first handle for use with/included in the device described herein, where in this example the first handle is a double-ring handle;

Figure 15 is a perspective view of an example of a second handle for use with/included in the device described herein, where in this example, the second handle is a single-ring handle ; and, Figure 16 is a top cross-sectional view of an example of the handle means and shaft assembly configuration of the device described herein.

Detailed Description of the Drawings

An example of a device 10 for retrieving a specimen, such as for example, a biological specimen, tissue or any biological matter during a surgical procedure is shown in Figures 1 to 16.

According to a particular example, as shown in Figure 1 , the device 10 includes a shaft member or shaft assembly 15. The shaft member 15 can have an external shaft 20 and an internal shaft 25, where the internal shaft 25 is configured to be moveable within the external shaft 20. Typically, it will be appreciated that movement of the internal shaft 25 is longitudinal within the external shaft 20 such that the device 10 moves between undeployed and deployed states (this is further described below). The shaft member 15 can further generally include a handle-end 30, and a specimen end 35, where the specimen end 35 is formed opposing the handle end 30.

The device 10 can further include a specimen retrieval means 40, which is typically operatively connected to the shaft member 15 at the specimen end 35. Additionally, the device 10 can further include an adapting member 45 connected to the internal shaft 25 at a first end 46 of the adapting member 45 and connected to the specimen retrieval means 40 at a second end 48 of the adapting member 45.

Typically, the device 10 also includes a handle means 32 connected to the shaft member 15 at the handle end 30, where the handle means 32 is at least partly moveable between a deployed state 50 (as shown in Figure 3) and an undeployed state 55 (as shown in Figure 2) to retrieve the specimen (not shown). According to one specific example, the internal shaft 25 has a different cross-section to the external shaft 20. Thus for example, the internal shaft 25 can have a square or rectangular cross-section and the external shaft 20 can have a round or circular cross-section. It will be appreciated by persons skilled in the art that, as described further below, the square cross- section of the internal shaft 25 can assist in locking or preventing rotational movement of the internal shaft 25 with respect to the external shaft 20, whereas the round or circular external shaft can be more readily sealed against possible fluid escaping from a patient’s body. This is also further discussed below.

Referring now more specifically to the handle means 32, the handle means 32 typically includes a first handle 34 and a second handle 36. In this example, the first handle 34 is attached or operatively connected to the external shaft 20 and the second handle 36 is attached to the internal shaft 25. The handle means 32 and first handle 34 and second handle 36 are shown in Figures 1 to 4, and 14 to 16.

In these examples, the handle means 32 includes at least one keyed portion, the at least one keyed portion being configured to limit/prevent rotational movement between the internal shaft 25 and the external shaft 20.

Thus for example, as more specifically shown in Figure 16, the first handle 34 can include a first keyed portion 90 to limit/prevent rotational movement of the internal shaft 25 with respect to the external shaft 20. According to a more specific example, the keying or locking mechanism 90 can be formed by the first handle 34 including a first channel 92 for receiving the external shaft 20 and the internal shaft 25. Typically, the first channel 92 includes one or more narrowed sections 94, where the narrowed sections 94 are formed to key or lock the internal shaft 25 from rotational movement with respect to the external shaft 20. Typically, keying or locking of the internal shaft (for rotational movement) occurs due to the narrowed section 94 being of a square cross- section, similar to that of the internal shat 25, such that the internal shaft 25 is restricted from rotational movement.

In addition to the keying provided by the first handle 34, it will be appreciated that there can be a keying or locking mechanism 96 provided by the attachment of the second handle 36 to the internal shaft 25.

According to another example, the second handle 36 can also include a second keyed portion 96 to limit/prevent rotational movement of the internal shaft 25 with respect to the external shaft 20. In this example, the second handle 36 includes a second channel 98 for receiving the internal shaft 25, the second channel 98 being formed to key or lock the internal shaft 25 from rotational movement with respect to the external shaft 20, by attaching the internal shaft 25 to the second channel 98. In this example, the second channel 98 is of a square cross-section, thereby mating with the square cross- section of the internal shaft 25. It will be appreciated by persons skilled in the art that the internal shaft 25 can be connected to the second handle in any suitable manner. Further, it will also be appreciated that the inner shaft 25 operatively connects the second handle to the first handle.

Further, the first handle 34 can be a double-ring handle and the second handle 36 can be a single-ring handle, where in one example, the single-ring handle 36 is configured to rest or nest between each ring of the double-ring handle 34 when in the deployed state 50 (as shown for example, in Figure 3). That is, the space between the rings of the first handle 34 can be formed to mate with a lower part of the second handle so that the second handle 36 at least partially sits between the rings of the first handle 34. In accordance with a further example, and as described further below, the first handle 34 is spaced-apart from the second handle 36 such that the handle means 32 is configured for one-handed deployment of the device 10.

It will be appreciated by persons skilled in the art that the square cross section of the inner shaft 25 can prevent relative axial rotation between the inner shaft 25 and the double ring handle 34. This enables torque exerted on the double ring handle 34, to be transmitted to the inner shaft 25, and thus through the mounting device (referred to herein as the adapting member 45) and prongs 70 to the bag 72 (which is further described below).

More specifically, there is a two-part interaction between the square cross section of the inner shaft 25, and similarly square mounting surfaces in the double ring handle body 34 (i.e in the first channel 92). The mounting surfaces, further shown herein as the first keyed portions 90 at the distal end of the double ring body 34 (i.e. distal from the patient) typically run parallel to each of the corresponding shaft 25 faces thus locking their axial rotation. According to a further example, the surfaces of the first keyed portion 90 are typically offset to allow smooth linear or longitudinal motion of the shaft through the cavity/chan nel 92.

It will be appreciated that similar features in the single ring handle 36 at its proximal end (i.e. proximal to the patient) can also lock the handle 36 rotation with the inner shaft 25, and thus the rest of the device 10. In this more specific example, the outer or external shaft 20 can be glued to the double ring handle body 34, thereby also locking rotation of the first handle 34 to the other components of the device 10. This combination of features can enable torque applied to be transmitted through all major components of the device 10 and can thus improve control of the device 10.

According to one specific example, the adapting member 45 is configured to seal a space between the internal shaft 25 and the external shaft 20.

Referring to the adapting member 45, as shown more specifically in Figures 4 to 12, the adapting member 45 can act as adaptor between the internal shaft 25 and the external shaft 20, and can also assist to hold and stabilise the internal shaft within the external shaft.

In acting to hold and stabilise the internal shaft 25 within the external shaft 20, the adapting member 45 can assist to guide the internal shaft 25 within the external shaft 20, so that they are aligned in use of the device 10, such that any action at the handle-end of the device 10 can be transmitted to the specimen-end of the device 10. This is further described below as the adapting member 45 is operatively connected to a specimen retrieval bag 72 for collecting a biological specimen or the like.

In acting as an adaptor between the two differently shaped shafts (internal shaft 25 and external shaft 20), in order to provide a seal between the internal shaft 25 and the external shaft 20, the adapting member 45 can include a first sealing device 60, such as an O-ring or the like, at or near a centre 42 of the adapting member 45 to assist in sealing a space between the internal shaft 25 and the external shaft 20.

In the examples shown in Figures 1 and further in Figures 4 to 12, the inner shaft 25 typically extends approximately half way between the O-ring seat, which is configured to receive the O-ring 60, and the base of the legs 47. It will further be appreciated that the second sealing device 60 is typically formed of an O-ring to create a seal between the adapting member 45 and the external shaft 20, which can prevent gases used during surgical procedures or other liquids escaping. For example, insufflation gas (typically carbon dioxide - C02) can escape the peritoneum, where in procedures such as laparoscopic cholecystectomy, C02 is used to inflate the abdomen in order to allow medical practitioners to view the inside of the abdomen more clearly. However, if the gas used to inflate the abdomen escapes prematurely, this can cause deflation of the abdomen during the medical procedure, which can lead to vision of inside the abdomen being obscured and can disastrously affect the outcomes of the procedure. A sealing device 60 such as an O-ring typically compresses on both surfaces to create the seal, and can still deform such that friction between the adapting member 45 and the external shaft 20 is minimised.

In addition to the first sealing device 60, the device 10 can also include a second sealing device 65, which, according to one example, can be a ball shaped or a spherical sealer 65 placed at the second end 48 of the adapting member 45, to further assist in sealing the internal shaft 25. Notably, as further discussed below, the spherical sealer 65 typically dislodges when pulled at by the string 82.

The adapting member 45 can also include one or more legs 47 at the first end 46 of the adapting member 45, where the one or more legs 47 are configured to hold the adapting member 45 onto the internal shaft 25.

Referring more specifically to the adapting member 45, it will be appreciated that the one or more legs 47 can be attached to the internal shaft 25 by various attaching means. In one specific example, the one or more legs 47 are glued to an end of the internal shaft 25 and/or there can also be provided other attaching means such as, for example, stub pins (not shown) or the like on one or more of the legs 47 which are configured to fit into matching holes/apertures 49 on the end of the internal shaft 25 to strengthen the connection between the adapting member 45 and the internal shaft 25.

According to one specific example, the cross-section of the internal shaft 25 can be different to the cross-section of the external shaft 20. Thus, the adapting member 45 can act as an adaptor between the two shafts 25, 20, as the adapting member 45 assists to interface between the two different cross- sections. The adaptor typically has an internal cross-section which corresponds to/matches the cross-section of the internal shaft, and an external cross-section that corresponds to/matches the cross-section of the external shaft.

It will be appreciated that this can allow an improvement in movement of the device from the deployed state 50 and undeployed state 55, where the internal and external shafts move longitudinally with respect to each other. Thus, for example the cross-section of the internal shaft 25 can be square and the cross-section of the external shaft 20 can be circular. By having the cross- section of the adapting member 45 circular, and the adapting member 45 attached to the internal shaft 25 at the specimen end 45, the adapting member 45 can interface with the external shaft 20 such that use of the handle means 32 can be smooth, in use, between the undeployed state 55 and deployed state 50, and the inside of the shafting means can then be appropriately sealed.

In addition to acting as an adaptor between the internal shaft 25 and the external shaft 20, the adapting member 45 can also be operatively connected or hold one or more prongs 70 at the second end 48. The prongs 70 are operatively connected to or hold, and in one example are typically threaded through a top portion 74 of a specimen retrieval bag or container 72, which is typically configured to hold the biological specimen once retrieved.

According to one specific example, the prongs 70 are moulded or overmoulded onto the adapting member 45. However, it will be appreciated by persons skilled in the art that the prongs 70 can be attached to the adapting member 45 by any suitable form or method.

Further Examples

According to one specific example, in use, the device 10 as described herein can be used in laparoscopic surgery to remove a biological specimen such as a gallbladder, or the like. It will be appreciated that the device described herein can be used for other surgical procedures where suitable. When in the undeployed state 55, as shown in Figure 2, the internal square shaft assembly 25 is within the outer shaft 20 passing through an opening in the double ring grip 34. Typically, the specimen retrieval bag 72 is retained, and in a rolled up or closed position inside the outer shaft 20 with the prongs 70 compressed. In the undeployed state 55, the single ring grip/handle 36 is typically located 110mm to 130mm distally of the double ring handle 34. It will be appreciated by persons skilled in the art that the distance between the first handle member 34 and the second handle member 36 in the undeployed state 55 can allow for a one-handed deployment of the device 10 by a user. It will further be appreciated that 110mm to 130mm is an example range only and other lengths for the handle means 32 can be possible, depending on the design of the device 10, such as for example, the length of the device 10 and the dimensions of the specimen retrieval means 40.

When in the deployed state 50 the single ring grip 36 is pushed toward the double ring grip 34, thereby pushing the assembly comprising of the bag 72 forward, extending the bag 72 beyond the outer shaft 20, the prongs 70 (which are biased towards the open position, and have been compressed in the external shaft 20) will then typically spring apart, thereby opening the bag 72 and allowing tissue, biological materials, or specimen, to be placed inside the bag 72. Accordingly, the device 10 can assist in the retrieval of tissue safely through a port opening in a patient’s body.

As shown in Figures 1 and 11 to 13, the device 10 can include a string or string member 82. The string 82 is typically threaded all the way around the top portion 74 of the bag 72 and tied together with a slip knot 84 or the like just before the ball seal 65. The string 82 extends into and through the internal shaft 25, exiting the shaft 25 at the second handle 36 to be secured/retained by a tab 80 on the second handle 36.

Accordingly, in this specific example, once the tissue is inside the bag 72, the single ring grip 36 is pulled back, which triggers the bag 72 to be closed thereby tightening the slip knot 84 on the string 82. The tab 80 can then be pulled to release the string 82 from being held on a retainer 86 on the second handle 36, thereby also drawing the bag 72 closed. In this example, the bag 72 typically remains inside, where the string 82 passes through the patient cavity and is held at the retainer 86, outside the patient. The surgeon or a member of the medical team during surgery can then remove the device 10 from the port or opening within a patient, while the bag 72 remains inside the cavity, until the bag 72 is then retrieved by a surgeon through a port used during the operation/procedure.

It will thus be appreciated that the retainer 86 on the handle 36 (as shown more specifically in Figure 15) can act as a hook to thereby hold the string 82 on the second handle 36. Release of the string 82 can be activated by pulling on the tab 80.

Other features of the device 10 described herein can include:

- The internal shaft 25 can be a square steel shaft with a blue single ring grip 36 at the handle-end 30, and a ) prong mount (typically made from a type of plastic) adapter 45 at the specimen end 35.

- The prong mount adaptor 45 can serve a dual purpose, sealing the device 10 to prevent C02 escaping the peritoneal cavity through the device 10 via an O-ring 60 mounted on the outer diameter and a ball 65 closing the inner diameter, and serving to connect the prongs 70 to the shaft 25. The prongs 70 can be moulded or over-moulded into the mount and extend further proximally (up the shaft 25). The mount is then typically glued to the square shaft 25.

- The prongs 70 are fed into an upper volume of the TPU (thermoplastic polyurethane) bag 72 with a capacity of 200ml, and a high burst strength. It will be appreciated, however, that the bag can be of any required volume, such as 400ml, 600ml, and 1200ml, as required.

- The outer shaft 20 with a white double ring grip 34 at the handle-end 30, has a distal opening for that accepts the square shaft assembly 25 and a second opening at the specimen end 35 that allows the bag 72 to be deployed. - According to one specific example, a nylon braided string 82 is typically threaded through the TPU bag 72 along with the prongs 70, travels through the inside of the square shaft 25 to the blue single ring grip 36 where the string exits and is secured to a retainer. In this example, the string has a slip knot at the specimen end 35 before the bag 72 that enables the top of the bag 72 to be drawn closed (thus the string acts like a draw-string to pull the bag closed). A ball 65 located distally of the knot that inserts into the inner diameter of the prong mount 45, sealing the inner area of the shaft 25. A second knot can also be typically located near the distal exit point, enabling a loop to be formed. The tab 80 that is secured to the distal loop on the string 82, and secured in the retainer 86. The tab 80 enables easier release of the string from the retainer 86.

- It will be appreciated that although various manufacturing practices can be used to form the handle means 32, according to one example, similar to the way in which the adapting member 45 is attached to the shaft 25, the second handle 36 can include one or more pins that retain the second handle 36 to the inner shaft 25 for increased strength. Further, the second handle 36 can be formed of two halves which are typically welded together. Similarly, the first handle 34 can also be comprised of two halves welded together with the outer or external shaft 20 in place. In addition to this, glue or an adhesive means can then be applied between the outer shaft and the double ring handle 34, although in this example, the first handle 34 is not attached to the external shaft 20 by any further attaching means such as pins or the like.

Accordingly, the device 10 can be used for removing a specimen, such as a biological specimen during laparoscopic surgery. In this specific example, a surgeon or medical professional can insert the device 10 into a laparoscopic port and deploy the specimen bag 72 by pushing the second handle 36 toward the first handle 34 until the second handle 36 rests against the first handle 34. The surgeon will then typically determine that the bag 72 is open and will carefully place the specimen into the bag 72. Once the specimen is contained in the bag 72, the surgeon typically pulls the second handle 36 back to close the bag (thereby activating the draw string 82).

To release the bag 72 from the device 10, the surgeon can lift the tab 80 over the hook retainer 86 on the second handle 36 and pull the device 10 away. In this use example, typically, the tab 80 and string 82 will then travel through the device 10 and the bag 72 remains open so that the device 10 is disposed of as required. The surgeon can then carefully remove the bag 72 containing the specimen from the patient and continue with the surgical procedure. It will be appreciated that the device 10 can provide numerous advantages. For example, the device 10 can provide for a one-handed deployment for surgeons with a range of hand sizes. In addition to this, the inner shaft with a cross-sectional area that is square can provide resistance to twisting and thus the device can be deployed with more precise movement. That is, the square shape of the inner shaft 25 can key or lock rotation to the handle body and can thus increase resistance to independent twisting.

In addition to this, the tab 80 on the first handle 36 provides a mechanism by which the string 82 can be easily released by the user.

Furthermore, it will also be appreciated that the adapting member 45, together with the first sealing device 60 and the second sealing device 65 can provide a system whereby there is low or decreased leakage through the shaft member 15.

The term “comprise” and variants of that term such as “comprises” or “comprising” are used herein to denote the inclusion of a stated integer or integers but not to exclude any other integer or integers, unless in the context or usage an exclusive interpretation of the term is required.

Those skilled in the art will appreciate that the invention described herein is susceptible to variations and modifications other than those specifically described. All such variations and modifications are to be considered within the scope and spirit of the present invention the nature of which is to be determined from the foregoing description.