WO2007010208A1

WO2007010208A1 - Surgical device for trans-nasal use

Info

Publication number: WO2007010208A1
Application number: PCT/GB2006/002614
Authority: WO
Inventors: Eric Abel; Robie Brodie
Original assignee: University Court Of The University Of Dundee
Priority date: 2005-07-15
Filing date: 2006-07-14
Publication date: 2007-01-25
Also published as: GB0514512D0

Abstract

A surgical apparatus (20) For trans-nasal use comprises an outer tubular member (22), an intermediate tubular member (24) slidably mounted within the outer member (22) and moveable between retracted and extended positions, and an inner member (26) slidably mounted within the intermediate tubular member (24) and adapted to be moved between retracted and extended positions. The intermediate member (24) defines a constrained shape when retracted within the outer member (22), and an unconstrained shape when extended from the outer tubular member (22), and the inner member (26) defines an unconstrained shape when in an extended position. The surgical apparatus (20) further comprises end effector means such as a cutter (30) mounted on a distal end (28) of the inner member (26) for cutting tissue from a patient (44) during a biopsy procedure, for example. In use, appropriate extension and retraction of the intermediate and inner members (24, 26) permits the end effector means (30) to be steered through a body cavity to a target site.

Description

I

SURGICAL DEVICE

FIELD OF THE INVENTION

The present invention relates to a surgical device, and in particular, but not exclusively, to a minimally invasive access device for use in performing procedures, such as biopsy procedures, through the nose of a patient.

The present invention also relates to a surgical kit for use in performing procedures, such as biopsy procedures, through the nose of a patient.

BACKGROUND TO THE INVENTION

In current established diagnostic and surgical practices, it is common for a suitably trained medical practitioner to utilise endoscopic-type devices to visualise internal body cavities of a patient. For example, when diagnostic investigations are required in the throat region of a patient, this is often achieved by passing a flexible endoscope through a nostril, through the inferior meatus of the nose and round the naso-pharyngeal (N-P) bend into the pharynx. Conventional endoscopes have cable steered tips to aid insertion and to permit a wide field of vision in the throat. In this way, the throat and surrounding regions can be examined, for example, to identify suspicious lesions which may require further investigation, necessitating a histology based biopsy to be performed. In such cases it is very important to obtain a biopsy as quickly as possible after initial discovery, in order to identify and treat any cancer which may be present as soon as possible.

The most common method used for throat biopsy involves a large rigid endoscope, or operating laryngoscope, inserted through the mouth into the throat, which is represented diagrammaticaliy in Figure 1 of the drawings, wherein the operating laryngoscope is identified by reference numeral 10. Long rigid grasping and cutting instruments (not shown) are used through the channel 14 of the laryngoscope 10 to take the biopsy from the throat region 16. However, due to the gagging reflex elicited during access through the mouth, the large size and rigidity of the laryngoscope 10, and the awkward position of the patient, this procedure must be performed under general anaesthetic in the operating theatre. This inpatient technique has major drawbacks in terms of length of procedure, the delay in diagnosis and treatment that is associated with having to admit a patient to hospital to perform a biopsy, the staff and resources required and the concomitant cost. Furthermore, it is a source of great frustration to Ear Nose and Throat (ENT) doctors that they may view a large throat lesion in the clinic via the flexible endoscope, but cannot obtain a suitable biopsy without going through the lengthy inpatient route.

Techniques have been proposed which attempt to permit biopsies to be taken from lhe throat by access through the nose, without use of general anaesthetic. For example, endoscopes exist which incorporate a fibre-optic port and an instrument channel, permitting insertion of a suitable instrument. Almost all available naso- pharyngo scopes are circular in cross-section, meaning that the presence of the fibre- optic port, and separate instrument channel requires the outer diameter of such endoscopes to be greater than desirable, making it uncomfortable for most patients, and entirely unsuitable for others. This is partly due to the round cross-sectional shape being poorly suited to the shape of the inferior meatus of the nose, which is a tall slit (i.e., greater height than width). Additionally, the desire to minimise the outer diameter of such multi-component endoscopes generally compromises the size of biopsy which may be taken. In this regard, it is generally understood in the art that a biopsy volume equivalent to about a 3mm diameter sphere is an acceptable minimum size for cancer diagnosis. Accordingly, it is not uncommon for insufficient tissue to be harvested using prior art endoscopes employing instrument channels. Known endoscopes incorporating instrument channels generally require the appropriate instrument to be inserted into a proximal end of the endoscope, translated along the entire length of the endoscope, to exit the endoscope at a distal region thereof. Thus, the outer diameter of such endoscopes by necessity are relatively large in order to accommodate the internal passage of a suitable instrument, particularly an instrument incorporating a cutter or gripper or the like. Additionally, known endoscopes are generally required to be flexible to be steered, either passively or actively, through a cavity of a patient. Accordingly, such flexible endoscopes tend to be utilised with instruments which incorporate flexible stalks, such as coiled metal stalks, which may be passed through the appropriate instrument channel without affecting the positioning of the endoscope, and without the instrument stalk being plastically deformed. Consequently, due to the requirement for flexible instruments in current endoscope designs, such instruments lack effectiveness in many procedures, such as biopsy. That is, to effectively perform a procedure such as biopsy, a suitable holding force is required to push biopsy cutters against a site during cutting without buckling or slipping of the instrument. However, the requisite flexibility of the instrument stalk, as discussed above, means that buckling or slipping of the instrument is a well known and common occurrence, making the procedure awkward, clumsy and sometimes impossible for the practitioner to perform. For these and other reasons, the traditional general anaesthetic rigid endoscope procedure, despite its inherent drawbacks, is invariably chosen by the medical practitioner.

US 5,607,435 discloses an instrument for endoscopic-type procedures which utilises two or more concentric tubes, at least one of which is composed of a shape memory alloy to provide a degree of manoeuvrability. In the embodiments disclosed in US 5,607,435, the instrument incorporates a fibre-optic bundle and one or more further instruments such as a needle or scalpel or the like. In one embodiment the device includes a pair of tweezer arms mounted on an inner tube, wherein the tweezer arms are biased towards an open position when the inner tube is extended from an outer tube, and closed to grip an object when the inner tube and tweezer arms are retracted. The tweezer arms are intended simply to grip, and are inappropriate for cutting tissue. Furthermore, because the tweezer arms are biased towards an open position they must be capable of being completely retracted into the outer tube section to facilitate safe insertion into the body. Accordingly, this, in combination with the fibre-optic bundle, may result in the diameter of the outer tube section being too large for safe insertion through a patient's nostril to gain access to the throat. Furthermore, providing the optical viewing instrument in combination with a procedural instrument may cause visualisation problems for the user, in that providing viewing from the same position as the instrument offers limited perspective viewing to safely perform the required operation.

It is among the objects of the present invention to obviate or at least mitigate these and other problems with the prior art.

SUMMARY OF THE INVENTION According to a first aspect of the present invention, there is provided a surgical apparatus for trans-nasal use comprising: an outer tubular member; an intermediate tubular member slidably mounted within the outer member and moveable between retracted and extended positions, said intermediate member defining a constrained shape when retracted within the outer member, and an unconstrained shape when extended from the outer tubular member; an inner member slidably mounted within the intermediate tubular member and adapted to be moved between retracted and extended positions, wherein said inner member defines an unconstrained shape when in an extended position; and end effector means mounted on a distal end of the inner member, said end effector means adapted to perform procedures within body cavities of a patient.

The end effector may be adapted to perform surgical, medical or other physiological procedures to tissue within body cavities of a patient. The end effector may be adapted to cut tissue from the patient and retain said tissue for extraction from the patient

The end effector means preferably comprises cutting means. Alternatively, or additionally, the end effector means may comprise artery ligation clip jaws, gripping means, clamping means, spray means, injecting means or the like, or any suitable combination thereof.

Preferably, the outer tubular member is rigid, and preferably functions as a delivery member for permitting insertion of the apparatus into the nose of a patient and through the narrow inferior meatus thereof. Advantageously, the outer tubular member is substantially straight. Advantageously, at least a portion of the intermediate tubular member may define a curved profile when in an unconstrained state, such that when the intermediate tubular member is moved towards an extended position relative to the outer tubular member, the intermediate member begins to adopt its unconstrained curved shape. Accordingly, once the outer tubular member is positioned, for example, within the nasal cavity of a patient's nose, the intermediate tubular member may then be partially or fully extended to adopt its unconstrained, preferably curved shape to permit the end effector means to be translated to the target site. For example, the form of the intermediate tubular member may be adapted to permit the end effector means to be translated round the N-P bend to a site in the pharynx or larynx of the patient. Alternatively, or additionally, the intermediate tubular member may be formed and arranged to permit the end effector means to be translated or directed into a sinus region of a patient, such as the frontal sinus region and/or maxillary sinus region. The intermediate tubular member may be adapted to be manipulated to permit the end effector means to be translated or directed to various sites in a patient. Alternatively, the intermediate tubular member may be interchangeable lυ accommodate different applications.

Beneficially, the extent to which the intermediate tubular member is extended/retracted controls the orientation provided by said intermediate member.' Accordingly, once the required extension of the intermediate tubular member is achieved to direct the end effector means towards a target site, said end effector means may then be activated to cut and retain a volume of tissue to be extracted. Alternatively, the inner member may additionally be moved towards an extended position relative to the intermediate tubular member to adopt an unconstrained shape and to move the end effector means towards the required target site to, for example, cut a suitable tissue sample to be retained and subsequently removed.

Alternatively, or additionally, at least a portion of the intermediate tubular member may define a straight profile when in an unconstrained state.

It will be understood that the constrained shape of the intermediate tubular member conforms to the shape of the outer member.

Advantageously, the outer tubular member has a higher rigidity than that of the intermediate tubular member, such that insertion of the intermediate member into the outer member will cause the intermediate member to be elastically deformed to adopt its constrained shape without altering the shape of the outer member. In one embodiment of the present invention, the outer tubular member may be formed of a metal alloy, such as stainless steel or the like, or alternatively may be formed of a suitable plastic or composite material, for example.

Preferably, the intermediate tubular member comprises an elastic material, and more preferably a material exhibiting superelastic properties. Accordingly, the intermediate tubular member may be readily moved relative to the outer tubular member to adopt its constrained and unconstrained shapes without developing a permanent set while retaining a significant degree of rigidity to engage the cutting means against the target region of the patient's body with sufficient force to enable the end effector means to function properly. The intermediate tubular member may comprise a superelastic material, such as nitinol, or other superelastic metal alloy or the like.

Preferably, the intermediate tubular member has a higher rigidity than that of the inner member, such that said inner member will advantageously adopt the shape of the intermediate tubular member when the inner member is retracted into the intermediate member. The inner member, when retracted into the intermediate tubular member, may adopt a constrained or unconstrained shape depending on the extended positioning of the intermediate tubular member with respect to the outer tubular member. The inner member may thus be stressed to adopt the same shape as the intermediate member.

Preferably, the inner member comprises an elastic material, and more preferably a material exhibiting superelastic properties. Accordingly, the inner member may be elastically deformed when moved relative to the intermediate tubular member without plastic deformation occurring, while retaining a significant degree of rigidity sufficient to engage the cutting means against the target region of the patient's body. In preferred embodiments, the inner member is adapted to transmit an axial force of, for example, between I and 3 N, and possibly greater, to the target site within a body without resulting in buckling of said inner member. The inner member may comprise a superelastic material such as nitinol or the like, or other suitable superelastic metal alloy. Alternatively, the inner member may comprise a plastic or composite material, or the like.

Advantageously, at least a portion of the inner member may define a straight unconstrained shape. Alternatively, or additionally, at least a portion of the inner member may adopt a curved unconstrained shape, or may adopt an unconstrained shape which is part straight and part curved. Accordingly, a greater degree of manoeuvrability of the end effector means may be achieved. For example, the intermediate tubular member may be extended from the outer tubular member to extend round the N-P bend of a patient, and the inner member may then subsequently be partially or fully extended from the intermediate member to extend the end effector means towards the target site, for example, the tongue base region. Adjustments to the direction of travel, or aim, of the inner tubular member may be made by subsequent extension or retraction of the intermediate member.

In a preferred embodiment, the end effector means is adapted to be retained in an extended position relative to at least the intermediate tubular member. Advantageously, the inner member may be adapted to be retracted into the intermediate tubular member until the end effector means is positioned adjacent a distal end of said intermediate member. The end effector means may be adapted to abut the distal end of the intermediate member. Accordingly, the cutting means may be of a suitable size to cut and retain a relatively large tissue sample without affecting the outer diameter of the intermediate member, and thus also υf the outer tubular member which might otherwise render the apparatus unsuitable For trans-nasal applications. Alternatively, in some embodiments, where permitted the end effector means may be adapted to be retracted into the intermediate tubular member. Preferably, the end effector means comprises a cutting member, and more preferably a pair of cutting members adapted to be moved between an open position towards a closed position to cut a sample of tissue from a patient, and subsequently to retain said tissue sample between the cutting members to be retracted with the entire apparatus. Advantageously, the end effector means may be adapted to cut and retain multiple tissue samples.

In a preferred embodiment, the end effector means is releasably .secured to the inner member, permitting said end effector means to be readily removed and replaced, for example.

Preferably, the inner member is tubular. In one embodiment the end effector means may be actuated by at least one cable extending through a longitudinal bore defined by the inner member. Preferably, the end effector means, such as a cutter, is biased towards a closed position. For example, the end effector means may comprise biasing means, such as spring biasing means. In embodiments of the present invention, the end effector means may be adapted to be releasably retained in a closed position, for example by locking means or friction means or the like. Accordingly, the end effector means may be translated through a body cavity while eliminating or substantially reducing the possibility of the end effector means snagging on and damaging healthy tissue, which may cause considerable discomfort to the patient, require immediate medical attention and subsequently delay the procedure in hand. Additionally, by biasing or otherwise securing the end effector means in a closed position, the possibility of dropping a biopsy sample upon removal from a patient inherent in many prior art apparatuses is eliminated, or at least minimised.

Conveniently, the apparatus may comprise a sheath adapted to cover the end effector means whilst the apparatus is being inserted into a patient. Advantageously, the sheath may be releasable thereafter such that the end effector means may be exposed and actuated when in position.

Advantageously, the intermediate tubular member may be rotatably mounted within the outer tubular member. Alternatively, the intermediate tubular member is preferably rotatably fixed relative to the outer member. Preferably, the inner member is rotatably mounted within the intermediate tubular member. Accordingly, by rotatably mounting one or both intermediate and inner members, a greater degree of movement and orientation of the end effector means may be achieved, permitting a larger region within a patient's body to be accessed by the apparatus of the present invention. Alternatively, the inner member may be rotatably fixed relative to the intermediate tubular member.

Conveniently, at least one of the inner, intermediate and outer members may be coated with a low friction material, such as Teflon™ or the like, to minimise friction between the members when moved relative to each other. Beneficially, the apparatus may comprise a further, second intermediate tubular member, positioned between the first intermediate tubular member and the inner tubular member. The second intermediate tubular member may be adapted to be extended from and retracted into the first intermediate tubular member. Beneficially, the second intermediate tubular member may be adapted to adopt an unconstrained shape when in an extended position, wherein the unconstrained shape may be curved or alternatively, or additionally, may be straight. The second intermediate tubular member may thus be utilised to provide additional reach and/or manoeuvrability to the cutting means.

Advantageously, the end effector means may be substituted by other end effector means in the form of gripping means adapted to grip a foreign or other object located within a body cavity. For example, the gripping means may be adapted to remove a fishbone or the like which may have become lodged at a site in the throat.

In embodiments of the present invention, at least one of the inner and intermediate members may incorporate at least one and preferably a plurality of slots, wherein said slots increase the flexibility of said at least one tubular member. The slot or slots may be partially circumferential, or alternatively may extend along a spiral path lengthwise of the member.

Advantageously, at least one of the inner and intermediate tubular members may be formed of a strip of material wound in a helical arrangement. For example, the strip of material may be helically wound round the outer surface of a tubular forming mandrel.

Beneficially, at least one of the inner and intermediate members may comprise a plurality of parallel elongate members, circumferentially arranged and secured together to define said at least one tubular member. Preferably, the apparatus further comprises control means adapted to control movement of at least one, and more preferably all of the intermediate and inner members and the end effector means. Preferably, the control means is adapted to be coupled to the proximal end of one or both the intermediate and inner members, and optionally a portion of the outer tubular member. Advantageously, the control means may be adapted to effect linear translation of the inner and intermediate members relative to the outer member. The control means may be adapted to rotate the intermediate tubular member relative to the outer tubular member, and advantageously to rotate the inner member relative to the intermediate member. The control means may comprise a geared arrangement adapted to effect linear translation of at least the intermediate tubular member relative to the outer tubular member. In one embodiment, the geared connection may comprise a rack and pinion arrangement. Advantageously, a rack may be secured to a proximal region of the intermediate tubular member, wherein said rack is adapted to be engaged by a pinion wheel adapted to be operated by a user. The pinion wheel may be secured to an operating wheel, such as a rotary knob. Advantageously, the control wheel may be adapted to provide a mechanical advantage which makes movement of the rack, and thus intermediate member easier for a user. This is beneficial in circumstances where the intermediate tubular member has a relatively high stiffness, necessary for bending and maintaining the inner member, which inner member is also relatively stiff, round the N-P bend. The stiffness of the intermediate member necessitates relatively large forces to deploy and retract said member from and into the outer tubular member when in use. The mechanical advantage provided by the control wheel beneficially minimises the input force required from the user, and permits a degree of precision to be achieved during steering, with the geared arrangement allowing better and more accurate position control than with prior art devices.

In embodiments of the present invention, the inner member may be adapted to be directly translated by a user. This is appropriate in the present invention in that, in a preferred embodiment, the forces involved in deploying and retracting the inner tubular member relative to the intermediate tubular member are generally lower. A handle or the like, may be mounted on a proximal region of the inner member, where manipulation or translation of said user interface by a user advantageously results in the desired movement of the inner member. Advantageously, the handles may comprise control means adapted to control the end effector means. The apparatus may further comprise an endoscope adapted to be inserted into a nostril of a patient separately from the remainder of the apparatus. In one embodiment, the outer member is adapted to be inserted into one nostril, and the endoscope is adapted to be inserted into the other nostril. Alternatively, the outer member and the endoscope may be adapted to be inserted into the same nostril. Such an arrangement is permitted due to the advantageous disposition of the end effector generally distal to the end of the intermediate tubular member. Advantageously, the endoscope is adapted to permit a medical practitioner to view the target site during the procedure being performed. Beneficially, the end effector means may be adapted to permit fluid to be directed from the inner member towards a target site. For example, the end effector means may comprise an aperture aligned with an internal longitudinal bore of the inner member, wherein said bore is adapted to transmit a fluid, such as a local anaesthetic or the like. Conveniently, the apparatus may thus be adapted to spray a local anaesthetic or the like towards a target site, or along an intended path to be followed by the cutting means upon entry into a patient and manoeuvring towards the target site.

In embodiments of the present invention, the cutting means may be substituted by an alternative end effector, such as a gripper, clamping means, syringe, scalpel, suction tube or the like, or any suitable combination.

According to a second aspect of the present invention, there is provided a surgical apparatus comprising: an outer tubular member; an intermediate tubular member slidably mounted within the outer member and moveable between retracted and extended positions, said intermediate member defining a constrained shape when retracted within the outer member, and an unconstrained shape when extended from the outer tubular member; an inner member slidably mounted within the intermediate tubular member and adapted to be moved between retracted and extended positions, wherein said inner member defines an unconstrained shape when in an extended position; and an end effector mounted on a distal end of the inner member and positioned exteriorly of the intermediate tubular member.

According to a third aspect of the present invention, there is provided a surgical kit for use in trans-nasal procedures, said kit comprising; , ,

1 1

a surgical apparatus according to the first or second aspects and adapted to be inserted into a nostril of a patient; and an endoscope adapted to be inserted into a nostril of the patient to view at least the cutting means of the surgical apparatus. In one embodiment of the present invention, the surgical apparatus and endoscope may be adapted to be inserted into the same nostril, or alternatively may be adapted to be inserted into different nostrils.

According to a fourth aspect of the present invention, there is provided a method of removing a tissue sample from a body cavity, said method comprising the steps of: inserting a surgical apparatus according to the first or second aspects into a nostril of a patient and through the inferior meatus of the nose; extending the intermediate tubular member from the outer tubular member and round the N-P bend; and engaging the end effector means against a target site and activating said end effector means to remove and retain a sample of tissue.

Preferably, the method further comprises the step of extending the intermediate member to point the inner member towards the target site. Preferably, the method comprises the step of extending the inner member from the intermediate tubular member to move the end effector means towards the target site. Subsequent to this, the method comprises the step of applying a force to hold the end effector means against the site while a tissue sample is cut.

Preferably, the method further comprises the steps of retracting the intermediate member into the outer member, and optionally the inner member into the intermediate member, and subsequently removing the apparatus from the patient's nostril.

Advantageously, the method may comprise the step of inserting an endoscope into a nostril of the patient and directing said endoscope to visualise the target site. In one embodiment of the present invention, the surgical apparatus and endoscope may be adapted to be inserted into the same nostril, or alternatively may be adapted to be inserted into different nostrils.

According to a fifth aspect of the present invention, there is provided a method of removing a tissue sample from a body cavity, said method comprising the steps of: inserting a surgical apparatus according to the first or second aspects into a nostril of a patient; extending the intermediate tubular member from the outer tubular member to direct the cutting means towards a target site; and engaging the cutting means against a target site and activating said cutting means to remove and retain a sample of tissue.

The method according to the fourth aspect may be adapted for use in removing a tissue sample from a throat region of a patient, Alternatively, the method according to the fourth aspect may be adapted to remove a tissue sample from a sinus region of a patient. Alternatively, the method according to the fourth aspect may be adapted by the use of other end effector means to perform surgical, medical or other physiological procedures to tissue within body cavities of a patient.

According to a sixth aspect of the present invention, there is provided a method of performing surgical, medical or other physiological procedures on tissue within body cavities of a patient, said method comprising the steps of: inserting a surgical apparatus according to the first or second aspects into a nostril of a patient; extending the intermediate tubular member from the outer tubular member to direct the end effector means towards a target site; and engaging the end effector means against a target site and activating said end effector means to perform surgical, medical and other physiological procedures on said tissue.

BRIEF DESCRIPTION OF THE DRAWINGS These and other aspects of the present invention will now be described, by way of example only, with reference to the accompanying drawings, in which:

Figure 1 is a diagrammatic representation of a patient undergoing a current preferred throat biopsy procedure while under general anaesthetic, wherein access to the throat is achieved through the mouth of the patient; Figure 2 is a partial sectional perspective view of a distal end of a surgical apparatus in accordance with an embodiment of the present invention, wherein the apparatus is shown in a retracted configuration;

Figure 3 is a partial sectional perspective view of the surgical apparatus of

Figure 2, shown in an extended configuration; Figure 4 is a view of the surgical apparatus of Figure 2 shown inserted within a nostril of a patient during a trans-nasal investigation and biopsy procedure;

Figures 5 to 7 are diagrammatic sectional views of the nose and throat cavity of a patient, with the apparatus of Figure 2 shown in three different configurations to access three separate regions of the throat;

Figure 8 is a diagrammatic front view of the nose and throat cavity of a patient, showing relative lateral movement of the apparatus of Figure 2, when in use;

Figure 9 is a view of a surgical apparatus in accordance with an alternative embodiment of the present invention; Figure 10 is a diagrammatic sectional view of the nose and throat cavity of a patient, with an apparatus similar to that shown in Figure 9 when in use;

Figure 1 1 is a view of a surgical apparatus in accordance with an alternative embodiment of the present invention;

Figures 12 and 13 are views of a control apparatus suitable for use with the apparatuses shown in Figures 2 and 9.

Figure 14 is a view of a surgical apparatus for use in providing suction at a target site within a body cavity;

Figures 15 and 16 are respective views of alternative forms of outer surface of an intermediate tubular member of the apparatus of Figure 14; Figure 17 is a view of a surgical apparatus for use in injecting a fluid at a target site within a body cavity.

Figures 18 and 19 are views of an alternative control apparatus for use with, for example, the apparatuses shown in Figures 2 and 9;

Figures 20 and 21 are views of a further alternative control apparatus for use with, for example, the apparatuses shown in Figures 2 and 9;

Figure 22 is a diagrammatic sectional view of the nose of a patient, with the surgical apparatus of Figure 2 utilised in accessing the maxillary sinus region;

Figure 23 is a diagrammatic section view of the nose region of a patient showing the surgical device of Figure 2 accessing the frontal sinus region; Figure 24 is a diagrammatic top view of a modified surgical apparatus shown in use with the control apparatus of Figure 18, wherein the surgical device is configured for use in an artery ligation procedure; and

Figure 25 is an enlarged view of ligation jaws of the surgical apparatus of Figure 24. DETAILED DESCRIPTION OF THE DRAWINGS

Referring to Figure 2, there is shown a partial sectional view of a distal end of a surgical apparatus, generally identified by reference numeral 20, in accordance with an embodiment of an aspect of the present invention. Apparatus 20 comprises an outer rigid tubular member 22, an intermediate elastic tubular member 24 concentrically mounted within outer member 22, and an elastic inner member 26 concentrically mounted within intermediate member 24. Intermediate member 24 is slidably mounted within the outer member 22, whereas the inner member 26 is both slidably and rotatably mounted within intermediate member 24.

Mounted on a distal end 28 of the inner member 26 is a cutter 30, wherein the cutter 30 comprises first and second cutting jaws 32, 34. The jaws 32, 34 are shown in a closed position in Figure 2, and in use are actuated to move to an open position by cables 36, 38 which extend through a central bore of inner member 26 towards a proximal end (not shown) of the apparatus 20. When in a closed position, as shown in Figure 2, the jaws 32, 34 are adapted to retain a tissue sample once cut from a patient by jaws 32, 34, such that the tissue sample may be safely retracted from a patient's body. In the preferred embodiment shown, the cutting jaws 32, 34 are biased towards the closed position which advantageously permits the apparatus 20 to be safely inserted into a body cavity of a patient with minimal risk of the cutting jaws

32, 34 snagging on healthy tissue, which may otherwise cause discomfort to a patient and may indeed necessitate further medical attention. Additionally, biasing or otherwise retaining the cutting jaws 32, 34 in a closed position prevents or at least minimises the possibility of a tissue sample being dropped. It should be noted that the outer diameter of the cutter 30, when in a closed position, is preferably greater that the inner diameter of intermediate member 24, such that when the inner member 26 is retracted within the intermediate member 24, the cutter 30 preferably but not necessarily abuts the distal end of the intermediate tubular member 24 remains in an extended position. Accordingly, the respective diameters of both the intermediate member 24 and outer member 22 may be minimised, which advantageously permits the apparatus 20 of the present invention to be .specifically adapted for use in performing trans-nasal surgical procedures, as will be discussed in further detail below. Reference is now made to Figure 3 of the drawings in which there is shown a partial sectional view of the distal portion of the apparatus 20 of Figure 2, wherein the inner member 26 is shown in an extended position relative to intermediate member 24, and the intermediate member 24 is shown extended from the outer member 22. It should be noted that extension and retraction of both the intermediate and inner members 24, 26 is achieved by linear translation of the members 24, 26 in the direction of arrows 40, 42, respectively. fn the extended configuration, a distal region of the intermediate member 24 adopts an unconstrained profile which is generally curved, such that extension or retraction of the intermediate member 24 relative to the outer member 22 orientates the cutter 30. In the embodiment shown, the inner member 26 has a normally straight unconstrained shape when extended from the intermediate member 24, while that portion of the inner member 26 which extends through the extended portion of the intermediate member 24 is forced to adopt the same curved shape as said member 24. Accordingly, the intermediate member 24 may be utilized to direct the cutter 30 in the required direction, while the inner member 26 may be extended to translate the cutter 30 towards the intended target site within a patient, as will be discussed in further detail below.

In the embodiment shown in Figures 2 and 3, the outer member 22 is formed of a metal alloy, such as stainless steel, which has a higher rigidity than the intermediate member 24, which is preferably formed of a superelastic material, such as the metal alloy nitinol. Accordingly, when the intermediate member 24 is retracted within the outer member 22, said intermediate member 24 will be forced to adopt a constrained straight configuration which conforms to that of the outer member 22, while having little or no deformation effect on .said outer member 22. Furthermore, the inner member 26 in the embodiment shown in Figures 2 and 3 is formed of a superelastic material, such as the metal alloy nitinol, and has a lower rigidity than the intermediate member 24. It will be understood that when the intermediate member 24 is extended from the outer member 22 to adopt its curved unconstrained shape, the intermediate member 24 will advantageously force the inner member 26 to adopt the same constrained shape, without any significant effect from the inner member 26 on the intermediate member 24 when extended from the outer member 22.

As noted above, the intermediate and inner members 24, 26 are preferably formed of a superelastic material. Such material is particularly advantageous in that , _fi

it is capable of being readily formed into a desired shape, and will subsequently be capable of considerable clastic deformation from an unconstrained shape, while still exhibiting sufficient rigidity to resist deformation caused by, for example, forces which may be established when the apparatus 20 of the present invention is in normal use. That is, the apparatus 20, in comprising elements of superclastic material, will permit an end effector, for example the cutter 30, once deployed to apply a force at a target site suitable for cutting jaws 32, 34 to engage and cut a tissue sample without being substantially deflected. In preferred embodiments of the present invention, at least the inner member 26 is capable of withstanding loads of around IN to 3N, and possibly more, when freely extended from the intermediate member 24 by, for example, 70 mm.

Furthermore, in the case of the use of a superelastic metal alloy such as nitinol it is preferable in that the austenite finish (Af) temperature is less than the local ambient temperature, which is typically 20¹¹C, such that the intermediate and inner members 24, 26 display superelasticity at both room and body temperatures.

However, continued use may cause a degree of permanent deformation due to cyclic loading, and as such it may be preferred to provide the apparatus 20 as a disposable instrument.

The unconstrained curvature of the intermediate member 24 is preferably formed by constraining said member 24 around a mandrel of suitable curvature and then heating said tube to a sufficient shape setting temperature. In the embodiment shown, shape setting and the desirable super-elastic mechanical properties of the intermediate member 24 may be achieved by heating the member to a temperature in the range of 45O⁰C to 600⁰C for between 1 and 30 minutes followed by rapid cooling in water or air. The inner member 26 may be formed or heat treated in the same manner as the intermediate member 24, wherein the heat treatment is carried out while the member 26 is in a straight configuration or formed round a mandrel.

The preferred embodiment of the apparatus 20 shown in Figures 2 and 3 is specifically adapted for use in a trans-nasal approach to collecting tissue samples, for example from the throat or sinus regions of a patient. Accordingly, it is preferred that the outer diameter of the outer tubular member 22 be less than or equal to 4 mm to minimise patient discomfort and retain a sufficient degree of manoeuvrability of the apparatus 20 when in use. A diagrammatic representation of the surgical apparatus 20 in αse performing a trans-nasal biopsy procedure on a patient 44 is shown in Figure 4, The apparatus 20 is inserted into one nostril 46 of the patient 44, and a conventional endoscope device 48 is inserted into the patient's other nostril 50, wherein the distal ends of the apparatus 20 and endoscope 48 are manoeuvred to the required target site within the patient's throat. Accordingly, the throat region, for example, may be examined by a medical practitioner via the image provided by endoscope 48, and upon discovery of any suspicious lesion or the like the apparatus 20 of the present invention may be immediately thereafter inserted into the patient 44 and the cutter 30 (Figures 2 and 3) guided to the identified site to obtain a tissue sample, which may thereafter be retracted and histologically examined to provide a diagnosis. The apparatus 20 of the present invention accordingly permits a medical practitioner to provide such a diagnosis without reverting to the conventional inpatient procedure, as shown in Figure 1. Furthermore, the apparatus 20 of the present invention, by being provided separately from the endoscope 48, permits a perspective view of the target site to be displayed to the medical practitioner, thus allowing accurate visualisation to be achieved.

A diagrammatic sectional view of the nose and throat cavity of the patient 44 of Figure 4 is shown in Figure 5, with the apparatus 20 of the present invention shown in situ. Prior to insertion of the apparatus 20 into the patient 44, a nasal loading tube

51 made from a flexible plastic or elastomeric material or the like, may optionally be first placed through the nostril 46 into the inferior meatus 52 of the nose 54. Once the loading tube 51 is located in place within the nose 54 of the patient 44, the apparatus 20 may then be inserted while configured in a fully retracted position, as shown in Figure 2. When the apparatus 20 is inserted to the required extent into the nasal cavity, the intermediate member 24 may then be extended from the outer member 22 to thus translate the cutter 30 round the N-P bend 57, such that the unconstrained curve shape of the exposed part 24a of the intermediate member 24 may direct the cutter 30 downwardly towards the patient's throat region 56. The intermediate member 24 may adopt an unconstrained curve shape having a portion with a radius of curvature of between 15 and 30mm, for example, which in most cases will be sufficient to permit orientation of the cutter 30 round the N-P bend 57. Once sufficient extension of, for instance, the intermediate member 24 from the outer member 22 is achieved to point the cutter 30 in the required direction, which may be determined by viewing an image captured by endoscope 48 (Figure 4), the inner member 26 may then be extended from the intermediate member 24 to translate the cutter 30 to the target site, which in the example .shown in Figure 5 is a site in the epiglottis/vallecula/lower tongue base region 58. Once located at the target site 58, the cutter 30 may be activated to obtain a suitable tissue sample, which may then be retained by the cutter 30 and subsequently removed from the patient by retracting both the inner member 26 and intermediate member 24, and subsequently removing the entire apparatus 20 from the patient. The loading tube 51 aids insertion and removal of the outer tube in the no.se, providing a barrier between the apparatus 20 and the nose tissue. This is particularly useful if a number of biopsies/procedures are to be carried out, providing comfort for the patient as the apparatus 20 is inserted and removed a number of times.

In a similar manner to that described above with reference to Figure 5, the apparatus 20 may be utilised to direct the cutter 30 towards the piriform fossa 60 of the patient's throat 56, as shown in Figure 6, in order to obtain a suitable tissue sample therefrom. In this particular use, it is noted that the extent to which the intermediate member 24 is extended from the outer member 22 is less than that required to access the tongue base region 58 represented in Figure 5. However, a greater extension of the inner member 26 is required to reach the piriform fossa region 60. Such extension of the inner member 26 necessitates that said member 26 has sufficient rigidity to engage the cutter 30 against the tissue with adequate force in order to permit a suitable tissue sample to be obtained without buckling of the inner member 26.

Referring to Figure 7, the apparatus 20 is shown in a configuration suitable to locate the cutter 30 in the vocal chord/larynx region 62 of the throat region 56 of the patient. Accordingly, the apparatus 20 is adapted to access a wide range of positions in the throat region 56 of a patient by simply retracting and extending the intermediate and inner members 24, 26. Furthermore, rotational orientation of the cutter 30 may be achieved by rotating the inner member 26, while lateral positioning of the cutter 30 may be achieved by rotating the entire apparatus 20 about the longitudinal axis of the outer member 22, as generally represented in Figure 8, which is a diagrammatic front view of the nose 54 and throat cavity 56 of a patient.

Reference is now made to Figure 9 in which there is shown a diagrammatic representation of a surgical apparatus, generally identified by reference numeral 120, in accordance with an alternative embodiment of the present invention. The apparatus 120 is similar to the apparatus 20 first shown in Figure 2, and as such like features share like reference numerals, incremented by 100. Accordingly, the apparatus 120 comprises a rigid outer tubular member 122, within which is slidably mounted an elastic intermediate tubular member 124. An clastic inner tubular member 126 is slidably mounted within the intermediate member 124, and a distal end of said inner member 126 carries a .suitable cutter or other end effector (not shown in Figure 9). The apparatus 120 in Figure 9 is shown with the intermediate member 124 in an extended position relative to the outer member 122, and the inner member 126 in an extended position relative to the intermediate member 124. When extended, the intermediate member 124 adopts an unconstrained curved profile, and, likewise, when the inner member 126 is in an extended position, said member 126 also adopts an unconstrained curved profile. Accordingly, the apparatus 120 shown in Figure 9 may be utilised to direct the cutter through a tortuous path such as a single bend of a tight radius, or alternatively a serpentine cavity. For example, Figure 10 shows an apparatus, such as the apparatus 120 of Figure 9 inserted into the throat cavity 56 of a patient, wherein the intermediate tubular member 124 and the inner member 126 are extended to manoeuvre a cutter 130 round a tight radius to access a site within the throat region 56, such as the upper tongue base 64. Referring now to Figure 11, there is shown a further alternative embodiment of a surgical apparatus, identified by reference numeral 220, in accordance with the present invention. The apparatus 220 is similar to the apparatus 20 first shown in Figure 2, and as such like components share like reference numerals incremented by 200. In this embodiment, the apparatus 220 includes an outer tubular member 222, an intermediate tubular member 224, and an inner tubular member 226. The outer member 222 is rigid, whereas the intermediate tubular member 224 and the inner tubular member 226 are both elastic and adopt an unconstrained form when in an extended configuration. In the specific embodiment shown, the intermediate member 224 adopts a curved profile, as does the inner tubular member 226. However, it should be noted that in alternative embodiments, the inner tubular member may adopt a straight or other desired profile when in an extended configuration. The apparatus 220 further comprises a second intermediate tubular member 66 which is located between the intermediate member 224 and the inner member 226, wherein the second intermediate member 66 is adapted to be extended and retracted relative to the _o

intermediate member 224. As shown, the member 66 adopts a straight profile when in an extended position. However, it should be understood that the member 66 may alternatively be selected and formed to adopt a curved profile. Accordingly, in use, the apparatus 220 provides further manoeuvrability of a cutter or other end effector means (not shown) which may be coupled to a distal end of the inner member 226.

A control apparatus 70, suitable for use with cither of the apparatuses 20, 120, will now be described with reference to Figures 12 and 13. However, for clarity and brevity, the control apparatus 70 is shown in use with the surgical apparatus 20 first shown in Figure 2. The control apparatus 70 is rigidly .secured to the outer tubular member 22 and comprises a first gripping portion 71 which incorporates first and second handles 72, 74. Mounted on the gripping portion 71 is a control wheel 15 adapted to be rotated about a shaft 76, wherein the control wheel 15 is rigidly secured to a pinion wheel 78, shown in broken outline in Figure 13, wherein the pinion wheel 78 is thus rotatable about the shaft 76. In use, the pinion 78 engages a rack 80, also shown in broken outline in Figure 13, wherein the rack 80 is secured to the proximal portion of the intermediate member 24. Accordingly, rotation of the control wheel 15 in a first direction, for example by the thumb of a user, may cause the intermediate member 24 to be extended from the outer member 22, as shown in Figure 12, and rotation in an opposite direction may subsequently cause the intermediate member 24 to be retracted into outer member 22, as shown in Figure 13. The large size of the control wheel 75 relative to the pinion wheel 78 provides a mechanical advantage which makes movement of the rack 80 and the pinion 78 easier for the user. The control apparatus 70 thus permits extension and retraction of the intermediate member 24 to be controlled by one hand of a user. Referring still to Figures 12 and 13, the control apparatus 70 further comprises a second gripping portion 82 which incorporates a first handle 84 adapted to be operated by a user's thumb, and a .second handle 86 preferably adapted to be operated by a user's fingers, most preferably by a user's index and middle fingers. Thus, the second gripping portion 82 may be operated by a single hand of a user. The first handle 84 is coupled to a proximal end of the inner member 26, whereas the second handle 86 is coupled to the control cables 36, 38 (Figure 2) which extend to control the jaws 32, 34 (Figure 2) of the cutter 30, wherein the second handle portion 86 is slidably mounted on the first handle portion 84. In use, the entire second gripping portion 82 may be translated via the first handle 84 in order to provide extension and retraction of the inner member 26. Additionally, sliding the second handle 86 relative to the First handle 84 in a First direction provides opening of the cutter and sliding the second handle 86 relative to the First handle 84 in a second direction provides and closing of the cutter 30 in order to obtain and store a tissue sample. Furthermore, rotation of the entire second gripping portion 82 may permit corresponding rotation of the inner member 26 relative to both the outer member 22 and intermediate member 24. It should be noted that use of a superelastic inner tubular member permits good torsional stiffness to be achieved and allows rotation of the cutter 30 by rotating the gripping portion. As described above, manoeuvrability of a surgical apparatus may be achieved by providing a rigid outer member, an elastic intermediate member, and an elastic inner member, wherein at least the intermediate member adopts a curved profile when in an extended position. It should be noted that this particular concept may be utilised in numerous devices adapted to perform various procedures which require such orientation. For example, a suction device 320 is shown in Figure 14 which comprises an outer tubular member 322, and an intermediate tubular member 324 slidably mounted within the outer member 322 and moveable between retracted and extended positions, wherein the member 324 is shown in Figure 14 in an extended position. The intermediate member 324 defines an unconstrained curved .shape when in an extended position, and as such may be adapted to provide manoeuvrability round a bend within a body cavity, such as the N-P bend. An inner tubular member 326 is slidably mounted within the intermediate member 324 and is also adapted to be moved between retracted and extended positions. In the example shown in Figure 14, the inner member 326 adopts a straight profile when in an extended position. However, it should be noted that the inner member 326 may be selected to adopt a curved profile when extended. The inner tubular member 326 defines an orifice 90 at a distal end thereof, and is coupled to a suction hose 92 at a proximal end thereof, wherein the suction hose 92 is in turn coupled to a suction means (not shown). The orifice 90 may be manoeuvred to a target site within a body cavity by retracting and extending the intermediate and inner members 324, 326, with the suction means then activated to permit a fluid or solid material to be sucked from the target site through the inner member 326 and the suction hose 92.

The intermediate member 324 of the device 320 shown in Figure 14 may be formed of a solid tubular body of a superelastic metal alloy material. However, in some instances it may be preferred to increase the internal diameter of the inner tubular member 326 to prevent clogging of said member when in use. Accordingly, a concomitant increase in the diameter of the intermediate member 324 may be necessary to accommodate the inner member 326. However, an increased tubular diameter may limit the elasticity of the member 324, which may ultimately compromise the achievable elastic deformation of said member. In view of this, it may be preferred to provide an intermediate tubular member 324 which incorporates a spiral cut or slots formed in an outer surface thereof. For example, Figure 15, which is an example of one form of the outer surface of the member 324, shows a spiral cut 94 formed in the surface of the member 324, which spiral cut 94 increases the flexibility of said member. An alternative arrangement is shown in Figure 16, in which staggered lateral slots 96 are provided which also act to increase the flexibility of the intermediate member 324.

Reference is now made to Figure 17 of the drawings in which there is shown a diagrammatic representation of a surgical device 420 similar to the device 320 shown in Figure 14. Accordingly, for brevity, the following description is intended to identify the main differences between the device 420 .shown in Figure 17, and the device 320 shown in Figure 14. The device 420 incorporates an outer tubular member 422, an intermediate tubular member 424, and an inner tubular member 426, wherein a distal end of the inner member 426 defines a needle 98 adapted to inject a fluid into a target site of a patient, wherein the fluid is directed internally of the inner tubular member 426 by a syringe 100 coupled to the distal end of the inner member

426.

A further embodiment of a control apparatus 500 is shown in Figures 18 and 19. Whilst the control apparatus 500 may be utilised in combination with any of the surgical apparatuses described above, for clarity said control apparatus 500 is shown in combination with the surgical apparatus 20 first shown in Figure 2. The control apparatus 500 comprises a handle portion 501 which incorporates a pistol grip portion 502 adapted to be held in one hand of a user. A proximal end of the outer tubular member 22 is rigidly secured to the handle portion 501 and thus may be inserted into the nostril of a patient by simple manipulation and manoeuvring of said handle portion 501.

A rack arrangement 503 incorporating a rack 504 and a base 505 (Figure 18) is slidably mounted on the handle portion 501, wherein a proximal end of the intermediate member 24 (Figure 19) is rigidly secured to the rack arrangement 503. A pair of control wheels 505 (only one shown) is rotatably mounted, side-by-side, on the handle portion via a shaft 506, wherein a pinion wheel (not shown) is located between the control wheels 504 and is rigidly secured to said shaft 506. The pinion wheel is engaged with the rack 504 of the rack arrangement 503 such that rotation of the control wheels 505 and thus pinion wheel will translate the entire rack arrangement 503. Accordingly, in the embodiment shown, clockwise rotation of the control wheels 505 will cause the rack arrangement 503 to be translated to extend the intermediate member 24 from the outer member 22, as shown in Figure 19, and anti- clockwise rotation of the control wheels 505 will cause the intermediate member 24 to be retracted into the outer member 22, as shown in Figure 18.

The rack arrangement 503 defines a longitudinal throughbore (not shown) within which is slidably mounted a rigid tube 507, which may be formed of .stainless steel, for example, wherein a proximal end of the inner member 26 (Figure 19) of the apparatus 20 is rigidly secured to said tube 507. Thus, translation of the rigid tube

507 within the throughbore of the rack arrangement 503 will effect extension and retraction of the inner member 26 to thus direct the cutter 30 towards a target site within a patient. Secured to a proximal end of the rigid tube 507 is a control mechanism 508 comprising handles 509, 510 which are secured to the cutter 30 and are operated to open and close the jaws 32, 34 of the cutter 30 in a scissor-like manner.

In use, the outer tube 22 is inserted into a patient's nostril by manoeuvring the pistol grip portion 502. When the outer tube 22 is in position, the control wheels 505 are rotated to extend the intermediate tube 24 by the required amount to direct the cutter 30, It is advantageous in this embodiment for the cutter 30 to be biased or otherwise secured in a closed position, which may be achieved by suitable spring biasing means, friction means or the like within the cutter 30 or suitable adaptation of the mechanism 508. Once extension of the intermediate member 24 is achieved and the cutter 30 is aimed in the desired direction, the user may advance the rigid tube 507 and extend the inner member 26 to move the cutter 30 towards the intended target site within the patient. At this stage the cutter 30 may be activated by the handles 509, 510 of the control mechanism 508.

A further alternative embodiment of a control apparatus 600 is shown in Figures 20 and 21 in combination with the surgical apparatus 20 first shown in Figure 2. However, it should be understood that the control apparatus 600 may be used with any other surgical apparatus described above. Apparatus 600 comprises a handle assembly 601 having a thumb-grip portion 602 and an end portion 603 coupled together via a bearing tube 604, upon which bearing tube 604 is slidably mounted a finger-grip portion 605. The outer tubular member 22 of apparatus 20 is rigidly secured at its proximal end to the end portion 603. Accordingly, the outer member 22 may be inserted into a no.stril of a patient by gripping the thumb-grip portion 602 and then manipulating of the entire handle assembly 601.

A first rigid tube 606 is secured to a rearward side of the finger-grip portion 605, wherein the proximal end of the intermediate tubular member 24 is secured to said first rigid tube 606. In use, a user may insert their thumb into the thumb-grip portion 602 and at the same time translate the finger-grip portion 605 using the index and middle fingers of the same hand, in the manner of operating a syringe. In this way, the intermediate member 24 may be extended from and retracted into the outer member 22 to correctly orientate the cutter 30 using only one hand.

A second rigid tube 607 is slidably mounted within the first rigid tube 606, wherein the proximal end of the inner tubular member 26 (Figure 21) of apparatus 20 is secured to said second rigid tube 607. Thus, translation of the second rigid tube 607 within the first rigid tube 606 will effect extension and retraction of the inner member 26 (Figure 21) to thus translate the cutter 30 towards a target site within a patient. A control mechanism 608 comprises handles 609, 610 and is coupled to the cutter 30 in such a manner as to permit the operation of jaws 32, 34 of the cutter 30 in a .scissor-like manner. Control mechanism 608 is also secured to a proximal end of the second rigid tube 607. In a further alternative embodiment of a control apparatus, not shown in the drawings, a pistol grip handle, similar to that shown in Figures 18 and 19 may be utilised to insert the outer tubular member of a surgical apparatus into a nostril of a patient, for example that apparatus 20 first shown in Figure 2. In use, one hand is used to grip the pistol grip handle, and the other hand may be used to operate a control mechanism, such as the scissor mechanism 508, 608 of Figures 18 to 21, in order to manipulate the intermediate and inner tubular members, and cutter, of the surgical apparatus. To facilitate this, the pistol grip handle may incorporate a trigger mechanism adapted to selectively mutually lock and unlock the intermediate and inner members. Thus, when mutually locked, the control mechanism may be manoeuvred to extend or retract both the intermediate and inner members, and when unlocked, the intermediate member may be held stationary, permitting only the inner member to be extended or retracted by the control mechanism. Accordingly,

. complete operation of the control apparatus may be achieved with one hand permanently gripping the pistol grip handle and the other hand operating the control mechanism.

The surgical apparatus 20 first shown in Figure 2 may be utilised in providing access to the throat region 56 of a patient 44 via the nose 54, as described above with reference to Figures 5 to 10. It should be understood, however, that the apparatus 20, and indeed the apparatuses 120, 220, 320, 420, respectively, may be utilised in providing access to and performing a particular function in other regions of a patient. For example, the surgical apparatuses 20, 120, 220, 420 may be utilised in providing access to the maxillary .sinus region 700, also known as the antrum, as shown in Figure 22, reference to which is now made. For convenience, the surgical apparatus 20 is shown in Figure 22. The antrum 700 can be accessed by an opening 702 in the nose 54, which opening 702 may be enlarged by a surgeon using a punch to cut away some bone, allowing easier access. The apparatus 20 is initially inserted through the nose 54 in a straight configuration with the intermediate tube 24 thereafter being extended from the outer tube 22 to .steer the end effector, which in this embodiment comprises a set of curved grasping forceps 30a, through the opening 702 and into the antrum 700. The steering function of the intermediate member 24 may be utilised to aim the forceps 30a at the desired site. The inner member 26 may then be deployed to push the forceps 30a towards the site and subsequently apply a suitable force to perform the required operation. The forceps 30a may be rotated by rotating the inner member 26 in the desired manner, allowing the forceps 30a to be oriented as required.

The multiple degrees of freedom provided by the apparatus 20 allow access to sites which have heretofore been unreachable with fixed keyhole surgery tools and techniques. Of particular advantage is the ability of the present apparatus 20 to achieve access to the alveolar recess 704 in the antrum 700. The surgical apparatus of the present invention, such as the surgical apparatus

20, may be utilised in providing access to the frontal sinus region of a patient, as demonstrated in Figure 23, reference to which is now made, As shown, the apparatus 20 is inserted into a patient's nose 54, with the intermediate and inner members 24, 26 being extended to aim and guide the cutter 30 into the frontal sinus region 706 and _,

26

towards a target site therein. As shown in Figure 23, the intermediate tubular member 24 is arranged to adopt an upwardly curved unconstrained .shape when extended from the outer tube 22.

Reference is now made to Figure 24 of the drawings in which there is shown a modification of the surgical apparatus 20 first shown in Figure 2, for use in ligation or clipping of one or more portions of the internal maxillary artery, such as the sphenopalatine artery. In the arrangement illustrated in Figure 24, the apparatus 20 (seen from above), is shown in use with the control apparatus 500 first described with reference to Figure IcS. The apparatus 20 incorporates a modified end effector in the form of a set of artery ligation clip jaws 30b, which are shown in the enlarged view in

Figure 25 carrying a ligation clip 708. For the particular application o^ artery ligation, the apparatus 20 is adapted to steer the jaws 30b to any required angle to align the jaws 30b to approach the artery substantially perpendicularly. Such a perpendicular approach is achievable by virtue of the curved intermediate tube 24 and the ability to rotate the jaws 30b via the inner tube 26 (not visible in Figure 24). Such versatility which is an inherent feature of the structure of the present invention substantially improves on prior art devices which generally necessitate the provision of a range of different fixed jaw angles which makes artery ligation difficult in many cases. In the arrangement shown in Figure 24, the intermediate member 24 is adapted, by suitable treatment at manufacture or assembly, or by manipulation by a user, for example, to have a curved shape which may be directed when required to the left relative to the control apparatus 500. In circumstances where access to the right is required, the intermediate tubular member 24 may be readily redirected or, in a non-rotating version, be replaced with an appropriately formed substitute. The present invention provides significant benefits by the provision of an inner member which carries a suitable end effector, such as a cutter, wherein the inner member is provided with or exhibits sufficient flexibility to permit uncomplicated and accurate steering control of the end effector and stiffness or rigidity to permit the end effector to apply an adequate force against a target site within a patient. Additionally, the inner member exhibits torsional stiffness, permitting effective transmission of torque.

It should be understood that the^' embodiments described herein are merely exemplary, and that various modifications may be made thereto without departing from the scope of the invention. For example, the end effector attached to the distal end of the inner member may be adapted to spray liquid towards a region within a body cavity of a patient. For example, the end effector may be adapted to spray a local anaesthetic or the like. Furthermore, the intermediate tubular member of each disclosed embodiment may incorporate features such as surface slots or a spiral cutsuch as those described and shown in the surgical device example of Figures 14,

15 and 16, in order to increase the flexibility of the intermediate member.

In the embodiments described above, the inner member is formed of a siiperelastic material. However, the inner member may alternatively be formed of a plastic material, and may be corrugated, for example. The cutter in each of the embodiments described above may be removable from the inner member. Additionally, the various components of the apparatuses described above may be separable. Furthermore, at least part of, and preferably all of the apparatuses described above may be disposable.

Components of the apparatuses described above may be provided within an appropriately formed sheath, preventing direct contact of the components with a patient, permitting reuse of at least parts of the apparatuses.

Additionally, the cutter may be adapted to grip an object located within a body cavity, such as a foreign object which may become lodged in the throat region of a patient. The apparatuses described above may be suitable or adapted for use in other surgical procedures, such as in laparoscopic surgery, arthroscopy, urology or the like.

Claims

„

2o

CLAIMS:

I. A surgical apparatus for trans-nasal use comprising: an outer tubular member; an intermediate tubular member slidably mounted within the outer member and moveable between retracted and extended positions, said intermediate member defining a constrained shape when retracted within the outer member, and an unconstrained shape when extended from the outer tubular member; an inner member slidably mounted within the intermediate tubular member and adapted to be moved between retracted and extended positions, wherein said inner member defines an unconstrained shape when in an extended position; and end effector means mounted on a distal end of the inner member, said end effector means adapted to perform procedures within a body cavity of a patient.

2. The apparatus of claim 1, wherein the end effector means is adapted to cut tissue from a patient and retain said tissue for extraction from the patient.

3. The apparatus of claim 1, wherein the end effector means comprises cutting means.

4. The apparatus of claim 1, 2 or 3, wherein the end effector means comprises artery ligation clip jaws.

5. The apparatus of any preceding claim, wherein the end effector means comprises gripping means.

6. The apparatus of any preceding claim, wherein the end effector comprises injecting means.

7. The apparatus of any preceding claim, wherein the end effector comprises spray means.

8. The apparatus of any preceding claim, wherein the outer tubular member is rigid.

9. The apparatus of any preceding claim, wherein the outer tubular member is substantially straight.

10. The apparatus of any preceding claim, wherein at least a portion of the intermediate tubular member defines a curved shape when in an unconstrained state, such that when the intermediate tubular member is moved towards an extended position relative to the outer tubular member, the intermediate member begins to adopt its unconstrained curved shape.

11. The apparatus of any preceding claim, wherein the intermediate tubular member is adapted to permit the end effector means to be translated round the nasopharyngeal bend.

12. The apparatus of any preceding claim, wherein the intermediate tubular member is adapted to permit the end effector means to be translated into a sinus region of a patient.

13. The apparatus of any preceding claim, wherein, in use, the extent to which the intermediate tubular member is extended and retracted and rotated controls the orientation provided by said intermediate member.

14. The apparatus of any preceding claim, wherein at least a portion of the intermediate tubular member defines a straight profile when in an unconstrained state.

15. The apparatus of any preceding claim, wherein the constrained shape of the intermediate tubular member conforms to the shape of the outer member.

16. The apparatus of any preceding claim, wherein the outer tubular member has a higher rigidity than that of the intermediate tubular member.

17. The apparatus of any preceding claim, wherein the intermediate tubular member comprises an elastic material.

18. The apparatus of any preceding claim, wherein the intermediate tubular member comprises a material exhibiting superelastic properties.

19. The apparatus of any preceding claim, wherein the intermediate tubular member has a higher rigidity than that of the inner member.

20. The apparatus of any preceding claim, wherein, in use, the inner member, when retracted into the intermediate tubular member, adopts a constrained or unconstrained shape depending on the extended positioning of the intermediate tubular member with respect to the outer tubular member.

21. The apparatus of any preceding claim, wherein the inner member comprises an elastic material.

22. The apparatus of any preceding claim, wherein the inner member comprises a material exhibiting superelastic properties.

23. The apparatus of any preceding claim, wherein at least a portion of the inner member defines a straight unconstrained .shape.

24. The apparatus of any preceding claim, wherein at least a portion of the inner member defines a curved unconstrained shape.

25. The apparatus of any preceding claim, wherein the end effector means is adapted to be retained in an extended position relative to at least the intermediate tubular member.

26. The apparatus of any preceding claim, wherein the inner member is adapted to be retracted into the intermediate tubular member until the end effector means is positioned adjacent a distal end of said intermediate member.

27. The apparatus of any preceding claim, wherein the inner member is adapted to be retracted into the intermediate tubular member until the end effector means abuts a distal end of said intermediate member.

28. The apparatus of any preceding claim, wherein the end effector means comprises a cutting member.

29. The apparatus of any preceding claim, wherein the end effector means comprises a pair of cutting members adapted to be moved between an open position towards a closed position to cut a sample of tissue from a patient.

30. The apparatus of claim 29, wherein the cutting members are adapted to retain said tissue sample between the cutting members.

31. The apparatus of any preceding claim, wherein the end effector means is relcasably secured to the inner member.

32. The apparatus of any preceding claim, wherein the inner member is tubular.

33. The apparatus of claim 31, wherein the end effector means are actuated by at least one cable extending through a longitudinal bore defined by the inner member.

34. The apparatus of any preceding claim, wherein the end effector means is biased towards a closed position.

35. The apparatus of any preceding claim, further comprising a sheath adapted to cover the end effector means.

36. The apparatus of any preceding claim, wherein the intermediate tubular member is rotatably mounted within the outer tubular member.

37. The apparatus of any one of claims 1 to 35, wherein the intermediate tubular member is rotatably fixed relative to the outer member.

38. The apparatus of any preceding claim, wherein the inner member is rotatably mounted within the intermediate tubular member.

39. The apparatus of any one of claims I to 36, wherein the inner member is rotatably fixed relative to the intermediate tubular member.

40. The apparatus of any preceding claim, further comprising a further, second intermediate tubular member, positioned between the first intermediate tubular member and the inner tubular member.

41. The apparatus of claim 40, wherein the second intermediate tubular member is adapted to be extended from and retracted into the first intermediate tubular member.

42. The apparatus of claim 40 or 41, wherein the second intermediate tubular member is adapted to adopt an unconstrained shape when in an extended position

43. The apparatus of any preceding claim, wherein at least one of the inner member and intermediate tubular member defines at least one slot.

44. The apparatus of any preceding claim, wherein at least one of the inner member and intermediate tubular member is formed of a strip of material wound in a helical arrangement.

45. The apparatus of any preceding claim, wherein at least one of the inner member and intermediate tubular member comprises a plurality of parallel elongate members, circumferentially arranged and secured together to define said at least one member.

46. The apparatus of any preceding claim, further comprising control means adapted to control movement of at least one of the intermediate tubular member, inner member and the cutting means.

47. The apparatus of claim 45, wherein the control means is adapted to be coupled to the proximal end of at least one of the intermediate tubular member and inner member.

48, The apparatus of claim 46 or 47, wherein the control means is adapted to effect linear translation of the inner member and intermediate tubular member relative to the outer member.

49. The apparatus of claim 46, 47 or 48, wherein the control means is adapted to rotate the intermediate tubular member relative to the outer tubular member.

50. The apparatus of any one of claims 46 to 49, wherein the control means is adapted to rotate the inner member relative to the intermediate tubular member.

51. The apparatus of any one of claims 46 to 50, wherein the control means comprises a geared arrangement adapted to effect linear translation of at least the intermediate tubular member relative to the outer tubular member.

52. The apparatus of claim 51, wherein the geared arrangement comprises a rack and pinion arrangement.

53. The apparatus of any one of claims 46 to 52, wherein the control means is adapted to control the end effector means.

54. The apparatus of any preceding claim, wherein the inner member is adapted to be directly translated by a user.

55. The apparatus of any preceding claim, further comprising an endoscope adapted to be inserted into a nostril of a patient separately from the remainder of the apparatus.

56. The apparatus of claim 55, wherein the outer tubular member is adapted to be inserted into one nostril, and the endoscope is adapted to be inserted into the other nostril.

57. The apparatus of claim 55, wherein the outer tubular member and the endoscope are adapted to be inserted into the same nostril.

58. The apparatus of any preceding claim, wherein the end effector means is adapted to permit fluid to be directed from the inner member towards a target site.

59. The apparatus of any preceding claim, wherein the inner member is adapted to support a compressive force without buckling when extended from the intermediate tubular member.

60. The apparatus of any preceding claim, wherein the inner member is adapted to transmit an axial force of up to 3N to a target site when extended from the intermediate tubular member.

61. A surgical apparatus comprising: an outer tubular member; an intermediate tubular member slidably mounted within the outer member and moveable between retracted and extended positions, said intermediate member defining a constrained shape when retracted within the outer member, and an unconstrained shape when extended from the outer tubular member; an inner member slidably mounted within the intermediate tubular member and adapted to be moved between retracted and extended positions, wherein said inner member defines an unconstrained shape when in an extended position; and end effector means mounted on a distal end of the inner member and positioned exteriorly of the intermediate tubular member.

62. A surgical kit for use in trans-nasal procedures, said kit comprising: a surgical apparatus according to any one of claims 1 to 61 and adapted to be inserted into a nostril of a patient; and an endoscope adapted to be inserted into a nostril of the patient to view at least the cutting means of the surgical device.

63. The kit of claim 62, wherein the surgical apparatus and endoscope are adapted to be inserted into the same nostril.

64. The kit of claim 62, wherein the surgical apparatus and endoscope are adapted to be inserted into different nostrils.

65. A method of removing a tissue sample from a body cavity, said method comprising the steps of: inserting a surgical apparatus according to any one of claims 1 to 61 into a nostril of a patient and through the inferior meatus of the nose; extending the intermediate tubular member from the outer tubular member and round the naso-pharyngeal bend; and engaging the end effector means against a target site and activating said end effector means to remove and retain a sample of tissue.

66. A method of removing a tissue sample from a body cavity, said method comprising the steps of: inserting a surgical apparatus according to any one of claims 1 to 61 the first aspect into a nostril of a patient; extending the intermediate tubular member from the outer tubular member to direct the end effector means towards a target site; and engaging the end effector means against a target site and activating said end effector means to remove and retain a sample of tissue.

67. A method of performing surgical, medical or other physiological procedures on tissue within body cavities of a patient, said method comprising the steps of: inserting a surgical apparatus according to the first or second aspects into a nostril of a patient; extending the intermediate tubular member from the outer tubular member to direct the end effector means towards a target site; and engaging the end effector means against a target site and activating said end effector means to perform surgical, medical and other physiological procedures on said tissue.