WO2007029013A2

WO2007029013A2 - Surgical device

Info

Publication number: WO2007029013A2
Application number: PCT/GB2006/003337
Authority: WO
Inventors: James Robert Hewit
Original assignee: University Court Of The University Of Dundee
Priority date: 2005-09-10
Filing date: 2006-09-08
Publication date: 2007-03-15
Also published as: WO2007029013A3; GB0518495D0

Abstract

A surgical device (10) comprises an elongate member (12) defining at least one notch (16) in an outer surface thereof, wherein said elongate member (12) is adapted to be deformed in the region of said notch (16). The notch (16) is formed within the elongate member (12) at a location determined in accordance with specific patient requirements and geometries. A surgical instrument (14), such as a biopsy cutter, is mounted on an end of the elongate member (12).

Description

SURGICAL DEVICE

FIELD OF THE INVENTION

The present invention relates to a surgical device, and in particular, but not exclusively, to a surgical device for performing surgical procedures in the region of a patient's larynx/pharynx.

The present invention also relates to a method of manufacturing a surgical device.

BACKGROUND TO THE INVENTION

There are many instances where access to a patient's larynx/pharynx region is required, for example to harvest tissue biopsies to perform histology analyses, to remove foreign objects, such as fish bones, for example, to visualise the larynx/pharynx region using optical instruments, or to perform some other type of investigative or surgical procedure. Typically, a surgeon or other suitably qualified medical practitioner will seek access to the larynx/pharynx of a patient using Minimally Invasive Access (MIA) techniques which significantly reduces patient trauma and shortens recovery times. For example, a common approach is to gain access via the patient's mouth, as this permits a greater access area and allows the use of more conventional surgical devices, such as larger endoscopes and forceps and the like. Additionally, access through the mouth permits a greater degree of accuracy in directing and operating the necessary surgical instalments. However, access through the mouth requires the patient to be sedated, usually by general anaesthetic, in order to avoid gag reflexes as the instruments are inserted. There are well known safety concerns over the use of sedation, particularly general anaesthesia, which renders such surgical procedures potentially hazardous to the patient. Additionally, the requirement for sedation typically necessitates an in-patient patient procedure, which of course has significant cost implications and inconvenience for the patient.

However, it is known in the art to access a patient's larynx/pharynx via the nose to avoid the problematic gag reflexes, and thus eliminate the requirement for sedation. Nevertheless, nasal access requires the use of very specialised, smaller diameter devices and mechanisms to carry the required instrument, such as biopsy cutters or forceps to the target site due to the restricted passageway and convoluted path which must be followed. There are numerous surgical devices and instalments currently available for use in performing procedures in the region of a patient's larynx/pharynx. However, due to the variation in dimensions and geometries between different patients, it is necessary for hospitals and other medical centres to store a large quantity of the same instrument type in different sizes for use as required. This again has significant cost implications.

In any event, whichever method of access is utilised, the mechanism used to carry a surgical instalment, such as biopsy forceps, must have at least the following characteristics: it must be long enough and flexible enough to access that part of the larynx/pharynx where a tissue sample is to be taken, while being rigid enough to hold the forceps in place; it must be capable of orientating the forceps into the correct direction to take the sample; it must permit the forceps to be pressed into the tissue target site to be sampled without buckling or otherwise being deflected significantly; it must be useable for a wide variety of patients with differing dimensions and geometries; it must have an actuation method to operate the forceps to take a tissue sample. It is often the case that some of these requirements are provided at the expense of others.

It is among the objects of embodiments of the present invention to obviate or at least mitigate problems in the prior art.

SUMMARY OF THE INVENTION

According to a first aspect of the present invention, there is provided a surgical device comprising an elongate member defining a notch in an outer surface thereof, wherein said elongate member is adapted to be deformed in the region of said notch. Advantageously, the elongate member comprises at least first and second segments positioned on either side of the notch within the outer surface of said member, wherein the notch creates an interconnecting portion connecting the first and second segments. Thus, the presence of the notch within the outer surface of the elongate member establishes a region of reduced rigidity such that articulation between the first and second segments of the elongate member is permitted by deformation of the interconnecting portion. The first and second segments may be integrally formed, such that the interconnecting portion defines a living hinge. Alternatively, the first and second segment may be separately formed and secured together at the interconnecting portion and thus define the notch between the segments. Preferably, the elongate member is adapted to be inserted into a patient's body cavity, for example thorough an orifice such as the mouth, nasal passage or the like, or alternatively, or additionally, percutaneously via an incision. In a preferred embodiment, the surgical device is adapted for use in performing procedures in the region of a patient's larynx/pharynx. Beneficially, the device is adapted for access through a patient's nostril and nasal cavity.

Accordingly, in use, a surgical instalment may be mounted on or otherwise engaged with the elongate member, typically an end portion of said member, such that said surgical instrument may be oriented by deforming the member in the region of the notch and interconnecting portion. Advantageously, by being deformable in the region of the notch, deformation of the elongate member will be attainable in a controlled and predictable manner, allowing more accurate manoeuvring of said device while performing a surgical procedure, for example.

Preferably, the surgical device is adapted to accommodate or support a surgical instalment. Advantageously, the surgical device may comprise means for connecting a surgical instrument thereto. The connecting means may comprise threaded means, a quick connect coupling, an interference coupling or the like.

Alternatively, or additionally, the surgical device may be adapted to permit a surgical instrument to be inserted and passed therethrough. Accordingly, in this arrangement the surgical device may be deformed to be orientated in the required manner, and the appropriate surgical instalment then inserted therethrough to be guided towards the intended target site.

Advantageously, the surgical device may comprise a surgical instrument, wherein said surgical instrument may be adapted to be secured to the elongated member. For example, the surgical instrument may be adapted to be secured to an end portion of the elongate member. Alternatively, or additionally, the surgical instrument may be adapted to be inserted through a central bore of the elongate member from one end to the other. The surgical instrument may comprise forceps, such as gripping forceps or cutting/biopsy forceps or the like, a scalpel, a syringe, a cauterising tool, an optical instrument such as a fibre optic lens, or the like, or any suitable combination thereof.

Preferably, at least a portion of the elongate member is tubular, and defines an internal bore. In a preferred embodiment, the elongate member defines a through bore. The elongate member may be of any suitable cross-section, and may be circular, rectangular, square, ovoid or the like.

Advantageously, the notch extends substantially perpendicular to the longitudinal axis of the elongate member.

Preferably, the elongate member is adapted to be deformed to cause the notch to be closed or narrowed. Accordingly, with the notch in a closed position, further deformation of the elongate member may be limited, such that the deformed elongate member becomes substantially rigid permitting a surgical procedure, such as harvesting a tissue sample, to be performed while minimising inadvertent deflection of said elongate member. Advantageously, the elongate member is additionally, or alternatively, adapted to be deformed to cause the notch to be opened or widened.

The notch may be in the form of a slit, wherein side regions of the slit are substantially parallel. Alternatively, or additionally, the notch is preferably substantially wedge shaped, preferably v-shaped, and advantageously extends into the outer surface of the elongate member to define a notch angle. Thus, the elongate member may be deformed to cause said notch to close or narrow, such that the first and second segments of the member may be relatively orientated by an angle substantially equal to the notch angle. Beneficially, providing a sufficient degree of deformation of the elongate member may be achieved by careful selection of the notch angle defined in the outer surface thereof. In a preferred embodiment, the notch extends more than half way through the elongate member such that the interconnecting portion extends less than half the width of the elongate member. This advantageously provides a preferential degree of deformability in the region of said notch. Advantageously, where the elongate member comprises a tubular member, the notch preferably extends into the outer surface thereof to provide an interconnecting portion having a width substantially equal to the wall thickness of said tubular member. However, it should be understood that the notch may extend into the outer surface of the elongate member by any suitable amount, and may be selected in accordance with, for example, material type, application or the like. In one embodiment, the elongate member may be formed of a substantially rigid material, such that deformation is principally achieved in the region of the notch by virtue of the interconnecting portion. For example, the elongate member may be formed of a plastic material, composite, metal alloy or the like. Preferably, the elongate member is formed of a biologically compatible material. Preferably also, the elongate member is formed of a sterilisable and/or disposable material.

In a preferred embodiment of the present invention, the elongate member defines a plurality of notches distributed along the outer surface thereof. This arrangement permits the elongate member to be deformed more accurately and to adopt a more precise deformed profile. Thus, the notches may be strategically positioned along the length of the elongate member to provide the required deformation. Conveniently, the elongate member comprises a plurality of segments, wherein each adjacent segment is coupled together by respective interconnecting portions created by the notches.

Preferably, the notches are positioned in accordance with specific patient requirements and geometry. Advantageously, the notches are formed in the outer surface of the elongate member based on measurements taken from the patient, thus ensuring a bespoke device is formed to accurately access the desired target site, such as the larynx/pharynx. Measurements from the patient may be taken directly, or from appropriate imaging apparatus, such as scanning or X-ray equipment or the like. ' Beneficially, the notches may be formed by an automated, preferably computer controlled machine, wherein the machine cuts the notches in the required position in response to an input based on specific patient measurements.

In a preferred embodiment, the surgical device comprises control means adapted to control deformation of the elongate member. Preferably, the control means comprises at least one control cable extending longitudinally of the elongate body.

Advantageously, one end of the control cable may be secured to one of the first and second segments, wherein the other end of the cable is arranged to be operated by a user, for example by pulling to apply tension thereto, or releasing, in order to cause said elongate member to be deformed as required. Preferably, the control cable is adapted to cause the elongate member to be moved from an unstressed or non- deformed position to a stressed or deformed position by applying tension on said control cable. Conveniently, the elongate member may be adapted to be moved from a stressed position to an unstressed position by elastic recovery of the interconnecting portion. Alternatively, or additionally, cable control means may be provided to move the elongate member towards an unstressed position. In one embodiment of the present invention, the surgical device comprises a single control cable for controlling deformation of the elongate member. In an alternative embodiment, a plurality of cables are provided.

Preferably, the at least one cable extends internally of the elongate member. Alternatively, or additionally, the at least one control cable extends externally of the elongate member.

Advantageously, the surgical device may further comprise a control apparatus adapted to be coupled to and control actuation of the at least one cable. The control apparatus may incorporate a handle mechanism, such as a scissor-mechanism, syringe-mechanism or the like. Alternatively, or additionally, the control apparatus may comprise a rotatable knob or the like.

Preferably, the surgical device further comprises control means for controlling a surgical instrument, such as biopsy forceps, tweezers or the like. The surgical instrument control means may comprise at least one control cable extending longitudinally of the elongate member, possibly externally, but most preferably internally thereof. The surgical device may comprise a surgical instrument control apparatus adapted to be coupled to and control the at least one instalment control cable. The instrument control apparatus may be integral with a control apparatus for controlling actuation of the at least one cable for use in deforming the elongate body. Beneficially, the surgical device may further comprise a sheath adapted to at least partially cover the outer surface of the elongate member. Advantageously, said sheath may be adapted to cover the notch in the elongate body to prevent tissue or the like from becoming inadvertently positioned therein, which may otherwise cause injury to the patient and damage to the surgical device. The sheath may be formed of an elastic material, such as an elastomer. For example, the sheath may be formed of rubber, neoprene or the like.

According to a second aspect of the present invention, there is provided a surgical device for use in obtaining a tissue sample from a patient, said surgical device comprising: an elongate member defining a notch in an outer surface thereof, wherein said elongate member is adapted to be deformed in the region of said notch; and a surgical instrument mounted on the elongate body and adapted to cut a tissue sample from a patient. Preferably, the surgical device is adapted for use in obtaining a tissue biopsy sample from the larynx/pharynx region of a patient.

Preferably also, the surgical device is adapted to be inserted into a patient via the nasal cavity.

According to a third aspect of the present invention, there is provided a method of manufacturing a surgical device, said method comprising the steps of: providing an elongate body; and forming at least one notch in an outer surface of said elongate member such that said elongate member is deformable in the region of said notch.

By being deformable in the region of the at least one notch, deformation of the elongate member will be attainable in a controlled and predictable manner, allowing more accurate manoeuvring of said device while performing a surgical procedure, for example.

Preferably, the method further comprises the step of determining the required location of the at least one notch prior to forming said notch in the elongate member. Preferably, the location of the at least one notch is determined in accordance with specific patient requirements. Thus, the method according to the third aspect may be utilised to manufacture a bespoke surgical device, which will assist to ensure more accurate operation and manoeuvrability of the device when performing a surgical procedure on the patient. Advantageously, the step of determining the required location of the at least one notch comprises taking measurements from a patient. Beneficially, measurements may be taken directly from a patient, for example by directly measuring anatomical features in the region where the surgical device is intended to be used, such as in the throat. Alternatively, or additionally, measurements may be taken indirectly from a patient, for example by appropriate imaging apparatus, such as scanning or X-ray equipment or the like.

Preferably, the at least one notch is formed in the elongate member using a cutting machine, and most preferably a computer controlled cutting machine, wherein the method involves the step of inserting an elongate member into said cutting machine, and subsequently activating the machine to cut the at least one notch.

Beneficially, the method further comprises the step of inputting previously determined geometric data relating to the patient into the machine, wherein computer software running on the machine may be utilised to determine the required location of the at least one notch. Advantageously, the elongate member is tubular and defines a throughbore extending longitudinally therethrough.

Preferably, the method further comprises the step of securing a surgical instrument to the elongate member, preferably an end of the elongate member. The surgical instrument may be, for example, forceps, such as gripping forceps or cutting/biopsy forceps or the like, a scalpel, a syringe, a cauterising tool, an optical instrument such as a fibre optic lens, or the like, or any suitable combination thereof.

Advantageously, the method may further comprise the step of providing control means for controlling deformation of the elongate member and controlling a surgical instrument secured thereto. The control means may comprise one or more control cables extending along the length of the elongate member.

Preferably, the method comprises the step of forming a plurality of notches in the outer surface of the elongate member and along the length thereof, in order to provide a surgical device which may be deformed and ultimately manoeuvred in the required manner.

Preferably, the method according to the third aspect is adapted to form a surgical device according to the first and second aspects set forth above.

According to a fourth aspect of the present invention, there is provided a method of obtaining a tissue sample from a target site within a patient, said method comprising the steps of: providing an elongate member; forming at least one notch in an outer surface of said elongate member such that said elongate member is deformable in the region of said notch; securing a surgical instrument to the elongate member, said surgical instrument being adapted to cut a sample of tissue from the target site within the patient; directing the elongate member and surgical instrument towards a target site by deforming the elongate member in the region of the at least one notch; and activating the surgical instrument to cut a sample of tissue. Preferably, the method comprises the step of determining the required location of the at least one notch by taking measurements from the patient. Beneficially, measurements may be taken directly from the patient, for example by directly measuring anatomical features in the region where the surgical device is intended to be used, such as in the throat. Alternatively, or additionally, measurements may be taken indirectly from the patient, for example by appropriate imaging apparatus, such as scanning or X-ray equipment or the like.

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 surgical device, specifically a laryngeal biopsy sampling device, in accordance with an embodiment of an aspect of the present invention; Figures 2 and 3 are diagrammatic views of a portion of the device of Figure 1 shown during the manufacturing process according to an aspect of the present invention;

Figure 4 is an enlarged view of a portion of the device shown in Figure 1 ; and Figure 5 is a diagrammatic representation of the surgical device of Figure 1 , shown in use.

DETAILED DESCRIPTION OF THE DRAWINGS

Reference is first made to Figure 1 in which there is shown a surgical device, generally represented by reference numeral 10, in accordance with an embodiment of an aspect of the present invention. The device 10 is for use in obtaining a tissue sample From the larynx (and possibly pharynx) region of a patient and comprises an elongate tubular member 12 and a set of biopsy cutters/forceps 14 mounted on one end thereof. The forceps 14 may be of conventional form. A plurality of nicks or notches 16 are formed in an outer surface of the tubular member 12 and are distributed along the length thereof. In use, the notches 16 provide regions of localised reduced rigidity, such that deformation of the member 12 may be readily achieved in the region of said notches 16. That is, the tubular member 12 is permitted to be deformed to adopt a curved shape, as shown in Figure 1, by causing the tubular member 12 to be deformed thus narrowing or closing some or all of the notches 16. The tubular member 12 may also be deformed in the opposite direction causing the notches 16 to be widened.

Control cables (not shown in Figure 1) extend internally of the tubular member 12 and are adapted to control the forceps 14 and deformation of the tubular member 12. In use, the device 10 may be inserted into a patient, as shown in Figure 5 which is discussed in detail below, via the nasal cavity and oriented by deforming the member 12 in the region of the notches 16 to direct the forceps 14 towards the intended target site.

The device 10 may be manufactured in accordance with specific patient requirements and geometry. That is, anatomical measurements in the region of a patient's throat may first be taken, either directly or via suitable imaging equipment, and the geometric information then input into a computer controlled forming machine

(not shown). An uncut rigid tubular member 12, partially shown in Figure 2, is then

inserted into the forming machine which forms nicks or notches within the outer surface of the tubular member 12 at appropriate positions determined by software loaded onto the computer controlled forming machine. An enlarged view of a notch 16 formed in the outer surface of the tubular member 12 is shown in Figure 3. In the example shown, the notch 16 is substantially wedge shaped and defines a notch angle

of θ. This notch angle θ establishes the available deformability of the tubular member

in this region, and may be of any suitable size. The notch angle θ may also be

determined by computer software based on the patient's geometrical data. In some cases (not shown) it may be preferred for one or more of the formed notches to have a

notch angle of 0° such that these notches are in the form of slits. This arrangement

therefore permits deformation in one direction only, that is, the slits will only be capable of being widened.

Referring still to Figure 3, it is preferred for the notches to extend into the tubular member 12 such that an interconnecting portion 18 is formed which has a thickness substantially equal to the wall thickness of the tubular member 16. The interconnecting portion 18 thus secures together first and second adjacent segments 20, 22 of the tubular member while being capable of being suitably deformed as required.

Reference is now made to Figure 4 in which there is shown an enlarged view of a portion of the tubular member of the device shown in Figure 1, in the region of a notch 16. A first control cable 24 extends internally of the tubular member 12, one end of which cable 24 is coupled to an end portion of the tubular member, whereas the other end of the cable is arranged to be operated by a user. In use, tension is applied to the control cable 24 thus causing the notch(es) 16 to close to provide the required deformation of the tubular member 12. Upon release of the cable 24, elastic recovery of the interconnecting portion 18 returns the tubular member 12 to an unstressed position. A second control cable 26 extends through the tubular member for controlling the biopsy forceps 14.

Reference is now made to Figure 5 of the drawings in which there is shown a diagrammatic view of the surgical device 10 in use. The device 10 is inserted into the nasal cavity 28 of a patient 30 and is deformed according to the location and dimensions of the notches 16 to orientate and direct the forceps 14 towards the intended target site. Once in position, the forceps 14 may be activated to obtain the appropriate tissue sample to be extracted and analysed. Advantageously, by being deformable in the region of the notches, deformation of the elongate tubular member 12 will be attainable in a controlled and predictable manner, allowing more accurate manoeuvring of the device 10 while performing the biopsy procedure.

In some cases it is preferred to utilise a slightly curved and substantially rigid delivery or insertion tube 32 which is initially inserted into the nasal cavity 20 and extends to a region above the patient's larynx. This delivery tube 22 advantageously protects the soft nasal tissue during insertion and operation of the surgical device 10 of the present invention.

Upon insertion into the delivery tube 22, the device 10 is preferably orientated with the notches 16 being generally upwardly facing (with reference to the orientation of Figure 5), such that the tubular member 12 will adopt the curvature of the delivery tube 32. Once sufficient insertion is achieved, the entire device 10 may be rotated about its longitudinal axis to adopt the required orientation. As shown in Figure 5, the tubular member 12, when in situ, defines a substantially straight region 34 which

incoiporates notches 16a in the form of slits having a notch angle of 0°. Thus, this

region 34 may be deformed to negotiate the curved delivery tube 32, while being maintained in a straight configuration when in situ. It should be understood that the embodiment described herein is exemplary and that various modifications may be made thereto without departing from the scope of the invention. For example, any number, dimension and location of notches may be formed in the tubular member. Additionally, any number of control cables may be provided to operate the surgical device. Furthermore, any suitable surgical instalment may be utilised with the surgical device, such as a scalpel, tweezers, syringe, optical instrument or the like. The tubular member may be encapsulated by an elastic sheath to cover the notches to prevent inadvertent catching or nipping of tissue therein.

Claims

CLAIMS:

1. A surgical device comprising an elongate member defining at least one notch in an outer surface thereof, wherein said elongate member is adapted to be deformed in the region of said notch.

2. The surgical device of claim 1, wherein the elongate member comprises at least first and second segments positioned on either side of the notch within the outer surface of said member, wherein the notch creates an interconnecting portion connecting the first and second segments.

3. The surgical device of claim 2, wherein the first and second segments are integrally formed.

4. The surgical device of claim 2, wherein the first and second segments are separately formed and secured together at the interconnecting portion.

5. The surgical device of any preceding claim, wherein the elongate member is adapted to be inserted into a patient's body cavity.

6. The surgical device of any preceding claim, adapted for use in performing procedures in the region of a patient's larynx/pharynx.

7. The surgical device of any preceding claim, adapted to accommodate or

support a surgical instalment.

8. The surgical device of any preceding claim, further comprising means for connecting a surgical instrument thereto.

9. The surgical device of any preceding claim, adapted to permit a surgical instrument to be inserted and passed therethrough.

10. The surgical device of any preceding claim, further comprising a surgical instrument.

11. The surgical device of claim 10, wherein the surgical instalment is adapted to engage the elongated member.

12. The surgical device of any one of claims 8 to 11, wherein the the surgical instrument comprises at least one of forceps, gripping forceps, cutting/biopsy forceps, a scalpel, a syringe, a cauterising tool, an optical instrument.

13. The surgical device of any preceding claim, wherein at least a portion of the elongate member is tubular, and defines an internal bore.

14. The surgical device of any preceding claim, wherein the elongate member defines a through bore.

15. The surgical device of any preceding claim, wherein the notch extends substantially perpendicular to the longitudinal axis of the elongate member.

16. The surgical device of any preceding claim, wherein the elongate member is adapted to be deformed to cause the notch to be narrowed.

17. The surgical device of any preceding claim, wherein the elongate member is adapted to become substantially rigid when deformed to close the notch.

18. The surgical device of any preceding claim, wherein the notch is in the form of a slit comprising side regions which are substantially parallel.

19. The surgical device of any one of claims 1 to 17, wherein the notch is substantially wedge shaped and extends into the outer surface of the elongate member to define a notch angle.

20. The surgical device of claim 19, wherein the elongate member is adapted to be deformed in the region of the notch by an angle substantially equal to the notch angle.

21. The surgical device of any preceding claim, wherein the notch extends more than half way through the elongate member.

22. The surgical device of any preceding claim, wherein the elongate member is formed of a substantially rigid material, such that deformation is principally achieved in the region of the notch.

23. The surgical device of any preceding claim, wherein the elongate member defines a plurality of notches distributed along the outer surface thereof.

24. The surgical device of claim 23, wherein the notches are positioned along the length of the elongate member to provide a predetermined deformation.

25. The surgical device of claim 23 or 24, wherein the notches are positioned in accordance with specific patient requirements and geometry.

26. The surgical device of any preceding claim, comprising control means adapted to control deformation of the elongate member.

27. The surgical device of claim 26, wherein the control means comprises at least one control cable extending longitudinally of the elongate body.

28. The surgical device of claim 27, wherein one end of the control cable is secured to one of the first and second segments, and the other end of the cable is arranged to be operated by a user.

29. The surgical device of claim 27 or 28, wherein the control cable is adapted to cause the elongate member to be moved from a non-deformed position to a deformed position by applying tension on said control cable.

30. The surgical device of claim 27, 28 or 29, wherein the at least one cable extends internally of the elongate member.

31. The surgical device of any preceding claim, comprising a control apparatus for controlling said surgical device.

32. The surgical device of claim 31, when dependent on any one of claims 27 to

30, wherein the control apparatus is adapted to be coupled to and control actuation of the at least one cable.

33. The surgical device of any preceding claim, further comprising control means for controlling a surgical instalment.

34. The surgical device of claim 33, wherein the surgical instalment control means comprises at least one control cable extending longitudinally of the elongate member.

35. The surgical device of any preceding claim. Further comprising a surgical instrument control apparatus.

36. The surgical device of claim 35, when dependent on claim 34, wherein the surgical instrument control apparatus is adapted to be coupled to and control the at least one instrument control cable.

37. The surgical device of any preceding claim, further comprising a sheath adapted to at least partially cover the outer surface of the elongate member.

38. A surgical device for use in obtaining a tissue sample from a patient, said surgical device comprising: an elongate member defining a notch in an outer surface thereof, wherein said elongate member is adapted to be deformed in the region of said notch; and a surgical instalment mounted on the elongate body and adapted to cut a tissue sample from a patient.

39. A method of manufacturing a surgical device, said method comprising the steps of: providing an elongate body; and forming at least one notch in an outer surface of said elongate member such that said elongate member is deformable in the region of said notch.

40. The method of claim 39, further comprising the step of determining the required location of the at least one notch prior to forming said notch in the elongate member.

41. The method of claim 38 or 39, wherein the location of the at least one notch is determined in accordance with specific patient requirements.

42. The method of claim 41, wherein the step of determining the required location of the at least one notch comprises taking measurements from a patient.

43. The method of claim 42, wherein measurements are taken directly from a patient in the region where the surgical device is intended to be used.

44. The method of claim 42 or 43, wherein measurements are taken indirectly from a patient.

45. The method of claim 44, wherein indirect measurements are taken using an imaging apparatus.

46. The method of any one of claims 39 to 45, wherein the at least one notch is formed in the elongate member using a cutting machine.

47. The method of claim 46, further comprising the step of inputting previously determined geometric data relating to a patient into the machine, wherein computer software running on the machine is utilised to determine the required location of the at least one notch.

48. The method of any one of claims 39 to 47, further comprising the step of securing a surgical instalment to the elongate member.

49. The method of any one of claims 39 to 48, further comprising the step of providing control means for controlling deformation of the elongate member and controlling a surgical instalment secured thereto.

50. A method of obtaining a tissue sample from a target site within a patient, said method comprising the steps of: providing an elongate member; forming at least one notch in an outer surface of said elongate member such that said elongate member is deformable in the region of said notch; securing a surgical instrument to the elongate member, said surgical instrument being adapted to cut a sample of tissue from the target site within the patient; directing the elongate member and surgical instrument towards a target site by deforming the elongate member in the region of the at least one notch; and activating the surgical instrument to cut a sample of tissue.

51. The method of claim 50, further comprising the step of determining the required location of the at least one notch by taking measurements from the patient.