Background Art The paranasal sinuses are cavities found within the skull. Each sinus is lined with a mucosal layer and is filled with air. The sinuses communicate with the nasal cavity through relatively small apertures and any mucous produced by the mucosal layer of the sinuses is passed through the apertures and into the nasal passage.

It is common, however, for the sinuses to become infected, resulting in an increase in the production of mucous and blockage of the apertures. Such infection and blockage typically lead to intense pain around the frontal regions of the head and face of a sufferer and, in many instances, surgical intervention may be required to enhance the natural drainage and/or drain the sinuses.

Minimally invasive endoscopic surgery is the preferred option in most cases of intervention. Such procedure involves widening of the apertures connecting the sinuses to the nasal passage and removal of obstructing anatomical structures thereby enabling mucous and other fluids to drain from the affected sinus (es). Access to the apertures is typically quite a difficult procedure, however, due to the fact that each nasal cavity is divided into three areas by the projection of three turbinates from the lateral walls of the internal portion of the nose. The superior, middle and inferior turbinates essentially act as baffles to provide a large mucous-covered surface over which air must pass before reaching the pharynx. Furthermore, each turbinate possesses a rich blood supply which permits rapid warming and moistening of the dry inspired air.

To access the paranasal sinuses, a surgeon must typically push aside one of these turbinates. Due to the rich blood supply to the turbinate (s), however, such interference tends to lead to bleeding of the turbinates thus further obstructing the surgeon's view of the opening of the sinuses Furthermore, this procedure may cause damage to the turbinate (s) which may lead to post-operative discomfort for the patient. Indeed, in certain cases, the turbinate (s) may actually be broken as an endoscope is inserted into the nasal passage.

One means of preventing damage to a turbinate during an endoscopic procedure is described in US Patent No 5713839. This document discloses a splint which is inserted into a nasal passage of a patient, wherein the splint is adapted to engage the turbinate and pull it towards the septum of the nose.

The splint is then secured to the septum by a transseptal suture. This is a cumbersome procedure and the additional trauma of suturing the splint in position is undesirable and indeed may lead to infection of the mucous membrane of the septum in addition to discomfort for the patient.

The present invention provides a surgical retractor for use in nasal endoscopic surgery which overcomes the above problems of the prior art.

Disclosure of the Invention In a first aspect, the present invention provides a device for use in nasal surgery, the device including a first elongate member and at least a second elongate member pivotally connected to the first elongate member to allow the first elongate member to be moved relatively towards and/or away from the second elongate member; the arrangement of the device being such that at least a portion of the first elongate member may be inserted into a first nasal passage of a patient and at least a portion of the second elongate member may be inserted into a second nasal passage of the patient or caused to abut with the outside of the nose adjacent said second nasal passage and wherein the at least one portion of the first elongate member is adapted to move a structure in the first nasal passage from a first position to a second position and to retain the structure in the second position, the second elongate member acting to anchor the first elongate member in the first nasal passage.

In one embodiment, the structure in the nasal passage is a turbinate, typically the middle turbinate.

Typically, the at least one portion of the first elongate member of the device moves the middle turbinate towards the septum of the nose.

Preferably, the device includes two elongate members.

In use, the first elongate member and the second elongate member are movable relative each other between a first substantially closed position and a second open position. To enable insertion into the respective nasal passages, the first elongate member and the second elongate member are in the second open position. The elongate members are then moved from the second open position to the first substantially closed position such that the

first elongate member engages and moves the middle turbinate towards the septum of the first nasal passage and the second elongate member abuts the septum of the second nasal passage.

Preferably, the first elongate member and the second elongate member each include a lever. In this embodiment, movement of the two levers relative each other causes the elongate members to move between the first substantially closed position and the second open position.

In a preferred embodiment, each elongate member includes an integral arm portion. Each arm portion is typically at an angle to the remainder of the elongate member and preferably at an acute angle to the remainder of the elongate member.

The arm portions are preferably connected to each other by a pivot, said pivot including two opposed plate members which are held in position relative each other by a shaft member. Each plate member includes a base and at least one extension member which extends from the base in a direction towards the opposite plate member. Each extension member preferably includes a means to engage the shaft member. Typically, the shaft member is an elongate cylinder and the engagement means an aperture such that the elongate cylinder passes through the aperture of each extension member.

Preferably, each arm portion extends beyond the pivot to define a lever.

As each arm portion typically extends from the remainder of the elongate member at an angle, the levers are held in a position outside the nasal passage and preferably above the nose of the patient. Manipulation of the levers such they move towards each other causes the two plate members to circumferentially rotate around the elongate cylinder. In this embodiment, rotation of the plate members causes the elongate members to move from the first substantially closed position to the second open position.

At rest, the two levers are held in a spaced apart arrangement by a biasing means such as a spring. Typically the spring may be a compression spring although other types of spring are readily envisaged.

Preferably, both the first elongate member and the second elongate member are of the same length. Alternatively, the length of the elongate members may differ in relation to each other. For instance, the first elongate member will be of sufficient length to enable a distal portion to engage a turbinate of the nasal passage. It is envisaged that the second elongate

member need not be as long as the first elongate member in order to anchor the first elongate member in the first nasal passage.

Each elongate member is of a suitable diameter to enable insertion into the respective nasal passages of a patient whilst leaving space for insertion of medical instruments including endoscopes. The diameter of each elongate member, therefore, is preferably less than 1. 5mm and more preferably less than 0.5mm.

In one embodiment, the diameter of the second elongate member may be greater than the diameter of the first elongate member. It is envisaged that such a structure will further anchor the first elongate member in the first nasal passage.

The at least one portion of the first elongate member may comprise a paddle member to engage and move a turbinate.

A removable boot may be provided which locates over one or both of the elongate members to increase the surface area of the member.

Both the first elongate member and the second elongate member may further include a spur member for anchoring in to the mucosa of the septum thereby further securing each elongate member in the respective nasal passages.

Preferably the device is made from a relatively rigid and biocompatible material selected from the group comprising stainless steel, carbon fibre or plastics. In a particularly preferred embodiment, the device is made from a highly rigid structure such as a high strength polyurethane.

The device may be sterilised and subsequently re-used. Preferably, however, the device is disposable.

In another embodiment, the first elongate member may include an internal lumen along its length. An irrigation pipe may extend through the lumen to facilitate the introduction of irrigating fluid into the nasal passage when the device is in use. Alternatively, the irrigation pipe may be soldered to the first elongate member. Further, the irrigation pipe may be made from a relatively rigid material such as a high strength polyurethane. In this particular embodiment, the first elongate member may be made from a relatively less rigid material than the irrigation tube.

The first elongate member may further include a suction means for the removal of fluid from the nasal passage when the device is in use.

The first elongate member may also include a camera or light source or other sensory device at a distal end of the first elongate member.

The first elongate member may further include an electrocautery device.

The device of the invention is adapted for use during endoscopic procedures and, accordingly, in a preferred embodiment, at least a portion of the first elongate member includes a groove along its length such that the endoscope may be guided along the groove as it is inserted into the nasal passage of a patient.

In a further embodiment, the first and the second elongate members may be separated and each elongate member inserted separately into a respective nasal passage. Preferably, once positioned in the respective nasal passages, the two elongate members may be connected to each other to enable the first elongate member to be anchored in the first nasal passage.

In a second aspect the present invention provides a method of moving an internal nasal structure using the device of the first aspect, the method including the steps of: (a) moving the elongate members of the device relative each other from a first substantially closed position to a second open position; (b) inserting the first elongate member into a first nasal passage whilst simultaneously inserting the second elongate member into a second nasal passage; (c) moving the elongate members relative each other from the second open position to the first substantially closed position; such that the first elongate member moves a structure of the first nasal passage from a first position to a second position and retains the structure in the second position and wherein the second elongate member secures the first elongate member in the first nasal passage.

Typically, in use, a distal portion of the first elongate member is positioned between the middle turbinate of the nose and a lateral nasal wall.

When the elongate members are moved relative each other to the first substantially closed position, the distal portion of the first elongate member engages a turbinate of the nose and moves it in a direction towards the septum. In the second closed position, the turbinate is held in a retracted state thereby enabling visualisation of and access to the area of the opening of

a sinus (previously obscured by the turbinate). Typically, the middle turbinate is moved in this manner.

In a third aspect, the present invention provides a device including; first and second elongate members for insertion into nasal passages of a human, each member including an integral arm extending away at an angle therefrom, the arms being linked by a pivot means and wherein the proximal end of each arm defines lever means operable to rotate the arm about the pivot means; biasing means for biasing the levers apart and the elongate members together; wherein movement of the levers together counters the biasing means and causes the members to move apart.

Preferably, the arms and levers of the device are shaped such that, in use, the levers are located generally above the patient's nose and do not interfere with the surgical procedure.

Brief Description of the Drawings Figure 1 is a sagittal section through the nose, mouth, larynx and pharynx of a patient.

Figure 2 is a posterior view of a nasal passage of a patient.

Figure 3 is a perspective view of the device of the present invention.

Figure 4 is a cross sectional view through I-I of Figure 3.

Description of the Invention The device 10 of the present invention is typically used during endoscopic surgery of the nose and particularly during surgery of the paranasal sinuses of a patient.

The device 10 comprises a first elongate member 11 and a second elongate member 12 which are connected to each other by way of a pivot 13.

Each elongate member further comprises an integral arm 14 which bears a lever 15. The pivot 13 comprises a central cylindrical shaft 17 and two opposing plates 18 and 19. Each plate comprises a back member 20 and two extension members 21. The central cylindrical shaft 17 passes through apertures (not shown) in each extension member 21 such that plates 18 and 19 may be rotated around the central cylindrical shaft 17. Each plate is connected to a respective arm 14.

At rest, levers 15 are biased apart by a compression spring 22. In this position, the elongate members are held in a substantially closed position.

In use, however, it is required that the first elongate member 11 and the second elongate member 12 are moved into an open position to enable insertion of at least a portion of both elongate members into respective nasal passages of a patient by pressing levers 15 together.

In the open position, the two elongate members are simultaneously inserted into respective nasal passages of a patient. In the present example, the first elongate member 11 is inserted into the nasal passage subject of the operative procedure.

Depending upon which paranasal sinus is to be operated on, either the superior 23, middle 24 or inferior 25 turbinate is moved to enable access to the sinus. Typically, it is necessary to move the middle turbinate 24 in which case, a distal end 26 of the first elongate member 11 is positioned between the middle turbinate 24 and the inner wall 27 of the nasal passage.

Throughout the above procedure, the levers 15 are held pressed together by a user to counter the spring biasing means 22 and once the first elongate member 11 is in position, the levers 15 may be released thereby causing the first elongate member 11 and the second elongate member 12 to move to the substantially closed position under the action of the spring biasing means 22. Clearly, when inserted into respective nasal passages, the two elongate members will not fully close to an abutting position due to the fact that they are separated by the nasal septum. However, the biasing spring 22 holds the elongate members within the respective nasal passages without the need for further securing of the device.

Upon movement of the first and second elongate member to the substantially closed position, the first elongate member 11 engages the middle turbinate 24 and moves it in a direction towards the nasal septum 28.

Retraction of the middle turbinate in this manner facilitates access to the opening to the affected sinus. The arms 14 and levers 15 are shaped so that, in use, the levers are located generally above the patient's nose and do not inhibit access to the nasal passages of a patient.

It will be appreciated by persons skilled in the art that numerous variations and/or modifications may be made to the invention as shown in the specific embodiments without departing from the spirit or scope of the invention as broadly described. The present embodiments are, therefore, to be considered in all respects as illustrative and not restrictive.