MEDICAL PROBE, ASSEMBLY AND METHOD

Abstract

There is disclosed a medical probe for traversing a tract in the body of a human or animal. One medical probe is disclosed which comprises an elongate elastically deformable member comprising a helically wound element, and a sheath having an inner surface which contacts an outer surface of the elastically deformable member. The probe is elastically deformable, for traversing the tract, by virtue of the elastically deformable member. The probe may include a treatment element, which can be used to perform a procedure in the body of a patient. An assembly comprising a probe and a treatment element is also disclosed. The medical probe has a particular use in the treatment of a fistula, in which the probe takes the form of a fistula probe adapted to traverse a fistula tract.

Claims

1. A medical probe for traversing a tract in a body of a patient, the probe comprising: an elongate elastically deformable member comprising a helically wound element; and a sheath having an inner surface which contacts an outer surface of the elastically deformable member.

2. A probe as claimed in claim 1, in which the probe takes the form of a fistula probe adapted to traverse a fistula tract.

3. A probe as claimed in either of claim 1 or 2, in which the elastically deformable member has a first, rest configuration which the member adopts in the absence of an external load, the member being substantially straight when in the rest configuration.

4. A probe as claimed in claim 3, in which the elastically deformable member is movable to a second configuration on application of an external load, a restorative force of the elastically deformable member acting to urge the member to its rest configuration in the absence of the external load.

5. A probe as claimed in any preceding claim, in which the helically wound element is a spring having a plurality of coils, the spring being arranged so that the coils are in abutment, at least in a rest configuration of the elastically deformable member.

6. A probe as claimed in any preceding claim, in which the sheath is tubular, fitted over the elastically deformable member and deformed into contact with the outer surface of the elastically deformable member.

7. A probe as claimed in any preceding claim, in which the sheath extends from a leading end of the elastically deformable member part-way along a length of the member.

8. A probe as claimed in any one of claims 1 to 6, in which the sheath covers the entire outer surface of the elastically deformable member.

9. A probe as claimed in any one of claim 1 to 6 or 8, in which sheath extends along the elastically deformable member and over a trailing end of the member.

10. A probe as claimed in claim 9, in which a portion of the sheath extends beyond the end of the elastically deformable member.

11. A probe as claimed in any preceding claim, comprising a treatment element coupled to the elastically deformable member, so that the treatment element is drawn into the tract by the member.

12. A probe as claimed in claim 11, in which the treatment element is releasably coupled to the elastically deformable member so that it can be released from the member leaving the treatment element in place within the tract.

13. A probe as claimed in either of claims 11 and 12, in which the treatment element is flexible, tubular and elongate.

14. A probe as claimed in claim 13, in which the treatment element is a seton, comprising a passage extending along a length of the element between first and second open ends.

15. A probe as claimed in either of claims 11 and 12, in which the treatment element is a flexible elongate suture.

16. A probe as claimed in any one of claims 11 to 15, in which the sheath comprises a portion which extends beyond the end of the elastically deformable member, and in which the treatment element is located within said portion.

17. A probe as claimed in claim 16, in which the treatment element protrudes beyond an end of the sheath.

18. A probe as claimed in claim 13, in which the treatment element is arranged to engage the elastically deformable member in an interference fit.

19. A probe as claimed in either of claim 13 or 18, in Which the elastically deformable member has a first portion of a first diameter, and a second portion of a second diameter, the second diameter being smaller than the first diameter.

20. A probe as claimed in claim 19, in which the treatment element is arranged to engage the second portion of the elastically deformable member, and so that it does not extend on to the first portion.

21. A probe as claimed in any one of claims 13 or 18 to 20, in which the probe comprises the tubular treatment element and a further, flexible elongate treatment element.

22. A probe as claimed in claim 21, in which the further treatment element is coupled to the elastically deformable member via the tubular treatment element.

23. A probe as claimed in claim 22, in which the further treatment element is located within the tubular treatment element.

24. A probe as claimed in any one of claims 21 to 23, in which the further treatment element extends within an internal cavity defined by the elastically deformable member.

25. A probe as claimed in any one of claims 21 to 23, in which part of the further treatment element is located between an inner surface of the tubular treatment element and an outer surface of the elastically deformable member.

26. A probe as claimed in any preceding claim, comprising a leading end which is shaped to facilitate insertion of the probe into the tract.

27. A probe as claimed in claim 26, in which the leading end is tapered, and in which the probe tapers from a first outside diameter to a second smaller diameter at a lead-most part of the leading end.

28. A probe as claimed in either of claim 26 or 27, in which the leading end is defined by an end component which is coupled to the elastically deformable member.

29. A probe as claimed in either of claim 26 or 27, in which the leading end is formed by the elastically deformable member.

30. A probe as claimed in either of claim 26 or 27, in which the leading end is formed by the sheath.

31. A probe as claimed in any one of claims 26 to 30, in which the sheath extends over a leading end of the elastically deformable member.

32. A probe as claimed in any preceding claim, comprising a coupling feature for coupling a further component to the probe.

33. A probe as claimed in claim 32, in which the further component is selected from the group comprising: a cleaning tool; a seton; and a suture.

34. A probe as claimed in either of claim 32 or 33, in which the coupling feature is provided on the elastically deformable member.

35. A medical probe for traversing a tract in a body of a patient, the probe comprising: an elongate elastically deformable member comprising a helically wound element, the elastically deformable member having a leading end and a trailing end; a first, hollow treatment element located around an outer surface of the elastically deformable member and extending over the trailing end, the first treatment element having an inner surface which contacts an outer surface of the elastically deformable member; and a further treatment element located within the first elongate treatment element, in which the further treatment element is coupled to the elastically deformable member via the first treatment element.

36. A probe as claimed in claim 35, in which the first, hollow treatment element is a flexible elongate treatment element; the further treatment element is a flexible elongate treatment element; and in which the further treatment element is for performing a medical procedure in the body.

37. A medical probe assembly comprising the probe of any one of claims 1 to 36, and a treatment element coupled to the probe.

38. A probe assembly as claimed in claim 37, comprising a connecting element for joining a first end of the treatment element to a second end of the treatment element.

39. A probe assembly as claimed in claim 38, in which the treatment element is tubular and comprises first and second tubular ends, and in which the connecting element is insertable into the first and second ends to join the ends together.

40. A probe assembly as claimed in claim 39, in which the connecting element is insertable into one of the first and second ends; a portion of the treatment element at the other one of the first and second ends is adapted to be rolled back and the connecting element is insertable in said other end; and the portion that has been rolled back is adapted to then be rolled forward over the portion of the connecting element located in said other end.

41. A method of treating a tract in a body of a patient, comprising the steps of: coupling a first end of a treatment element to a medical probe according to any one of claims 1 to 36; inserting a leading end of the probe into a first opening of a tract trailing the treatment element; manoeuvring the probe along the tract and out of a second opening of the tract; removing the probe from the tract through the second opening; releasing the treatment element from the probe; removing the probe from the body of the patient leaving the treatment element in place within the tract, a first portion of the treatment element comprising the first end extending from the second opening of the tract, and a second portion of the treatment element comprising a second end extending from the first opening of the tract; and coupling the first end of the treatment element to the second end to form a loop and thereby retain the treatment element within the tract.

Description

[0080] Embodiments of the present invention will now be described, with reference to the accompanying drawings, in which:

[0081] FIG. 1 is a schematic cross-sectional illustration of an anal region of a patient suffering an anal fistula, the fistula forming a tract in the body of the patient;

[0082] FIG. 2 is a side view of a medical probe in accordance with an embodiment of the present invention;

[0083] FIG. 3 is a longitudinal sectional view of the probe shown in FIG. 2;

[0084] FIG. 4 is an enlarged longitudinal sectional view showing parts of an elongate elastically deformable member and a sheath of the probe shown in FIG. 2;

[0085] FIG. 4A is an enlarged view of the fistula shown in FIG. 1, showing the probe of FIG. 2 located within the tract;

[0086] FIG. 5 is a side view of a medical probe in accordance with another embodiment of the present invention;

[0087] FIG. 6 is a longitudinal sectional view of the probe shown in FIG. 5;

[0088] FIG. 7 is a side view of a medical probe in accordance with a further embodiment of the present invention;

[0089] FIG. 8 is a longitudinal sectional view of the probe shown in FIG. 7;

[0090] FIG. 9 is a side view of a medical probe in accordance with a further embodiment of the present invention;

[0091] FIG. 10 is a perspective view of a seton assembly in accordance with an embodiment of the present invention;

[0092] FIGS. 11 to 14 are enlarged schematic sectional views of the seton assembly of FIG. 10, illustrating steps in a method of treatment of a tract employing the seton assembly;

[0093] FIG. 15 is a side view of a medical probe in accordance with a further embodiment of the present invention;

[0094] FIG. 16 is a view of the probe shown in FIG. 15, sectioned about line A-A; and

[0095] FIG. 17 is an enlarged side view of the probe shown in FIG. 15, illustrating an alternative method of coupling a treatment element to an elongate elastically deformable member of the probe.

[0096] The present invention provides a medical probe for traversing a tract in the body of a patient, which may be a body of a human or animal patient. Whilst the medical probe has a particular use in traversing a fistula tract in the body, it may have a use in traversing other tracts in the body, including but not restricted to a tendon or ligament sheath, as well as tracts forming part of the vascular system such as arteries and veins.

[0097] Accordingly, and turning firstly to FIG. 1, there is shown a schematic view of an anal region 1 of a patient having an anal fistula, indicated generally by reference numeral 2. The fistula 2 comprises a tract 3 extending between the anal canal 4 and an exterior location 5 on the skin 6 of the patient, extending through the internal and external sphincter muscles 7 and 8. Fistula tracts typically have a width of around 2 mm, although this of course varies from patient to patient.

[0098] Turning now to FIG. 2, there is shown a side view of a medical probe in accordance with an embodiment of the present invention, the probe indicated generally by reference numeral 10. In the illustrated embodiment, which is involved in the treatment of a fistula 2, the probe 10 takes the form of a fistula probe. The probe 10 is also shown in the longitudinal sectional view of FIG. 3.

[0099] The probe 10 comprises an elongate elastically deformable member 12, which comprises a helically wound element 14, also shown in the enlarged view of FIG. 4. The probe 10 also comprises a sheath 16 having an inner surface 18 which contacts an outer surface 20 of the elongate elastically deformable element 12.

[0100] The probe 10 is elastically deformable, its elastic characteristics being provided by the elastically deformable member 12. This facilitates movement of the probe 10 along the fistula tract 3, as the probe 10 can readily elastically deform so as to conform to the tortuous shape of the tract 3. This is best shown in FIG. 4A, which shows the probe 10 located within the tract 3. In addition, the sheath 16, which contacts the outer surface 20 of the elastically deformable member 12, prevents body tissue from entering between coils or turns 22 of the helically wound element 14. This reduces discomfort to the patient and eases passage of the probe 10 along the fistula tract.

[0101] The elastically deformable member 12 has a first, rest configuration which it adopts in the absence of an external load or force, the member shown in FIG. 2 in its rest configuration. The elastically deformable member 12 is moveable to a second configuration on application of an external load or force which may be imparted upon the member 12 during passage along the fistula tract 3 and/or by a medical practitioner. This is illustrated in FIG. 4A, which shows the probe 10 in a second, bent configuration, following insertion into the tract 3.

[0102] The sheath 16 imparts a force on the elastically deformable member 12 which acts to restrict return movement of the member 12 to its first configuration to a certain extent, in the absence of an external load. Such may be due to the way in which the sheath 16 is fitted to the outer surface 20 of the elastically deformable member 12. The sheath 16 may be arranged so that it does not substantially restrict return movement of the member 12 to its first configuration. Optionally however, the sheath 16 can be arranged to restrict return movement of the elastically deformable member 12 to the first configuration, so that it adopts a third configuration in which it still be deformed (i.e. bent). In this case, a degree of deformation of the elastically deformable member 12 in the third configuration is less than in the second configuration. This may provide the fistula probe 10 with a degree of imperfect elasticity, which may assist in traversing the fistula tract 3. The extent to which the sheath 20 restricts/prevents movement of the elastically deformable member 12 may be determined by factors including: a material of the sheath; a thickness of a wall of the sheath; and inherent resilience of the elastically deformable member.

[0103] The elastically deformable member 12 has a longitudinal axis L, and may be capable of being deformed so that a portion or portions of the member are displaced from the axis. The deformable member 12 may be capable of being deformed so that a portion or portions of the member are disposed at a (non-parallel) angle relative to the axis L. The angle may be up to at least 90% may be up to at least 180, may be up to at least 270, and may be up to at least 360. This may allow the deformable member 12 to be significantly deformed, including to be looped back on or over itself, which may facilitate negotiation of a particularly tortuous tract.

[0104] In the illustrated embodiment, the elastically deformable member 12 takes the form of a spring having a plurality of turns or coils 22 (FIG. 4). The spring can have any suitable diameter, but typically will have a diameter in the region of 1.5 mm, so that it is capable of passing along fistula tracts which typically have a width of 2 mm, as discussed above. It will be understood that the probe may be of different dimensions depending upon its intended use, and in particular a diameter of the tract that it is to traverse. A pitch of the spring 12 is selected so that each coil 22 is in abutment with an adjacent coil or coils, in the rest configuration of the spring. In this way, there are no significant gaps between adjacent coils 22 of the spring 12 when it is in its rest configuration. Suitably, the helically wound element 14 forming the spring 12 is of a metal material, in particular a stainless steel material, which is known as being suitable for medical uses.

[0105] The sheath 16 is a substantially tubular member which is fitted over the spring 12. In the illustrated embodiment, the tubular sheath 16 covers the entire outer surface 20 of the spring 12, save for a coupling feature 24 defined by the spring 12, and which will he described in more detail below. The sheath is typically relatively thin-walled, and may have a wall thickness of 0.1 mm or less. The tubular sheath 16 defines the inner surface 18 which contacts the outer surface 20 of the spring 12. The tubular sheath 16 is deformed into contact with the outer surface 20 of the spring 12, suitably by heat-shrinking the sheath into contact with the outer surface 20. To this end, the sheath is suitably of a plastics material, particularly a polymeric material, and preferably polytetrafluoroethylene (PTFE) or fluorinated ethylene propylene (PEP). MIT and PEP are known to be biocompatible and have relatively low coefficients of friction, the latter facilitating fitting of the tubular sheath 16 to the spring 12, as well as passage of the probe 10 along the tract 3. PEP may be particularly suitable for heat-shrinking, as it has a lower melting point than PTFE.

[0106] The probe 10 has a leading end 26 and a trailing end, the leading end 26 adapted to be inserted into an opening of the fistula tract 3, in this case an exterior opening 30 (FIG. 4A). The leading end 26 is suitably tapered or otherwise shaped to facilitate insertion of the probe 10 into the tract 3, and passage of the probe along the tract. The probe tapers from a first outside diameter D.sub.1 to a second smaller diameter D.sub.2 at a lead-most part 32 of the leading end 26.

[0107] The tapered leading end 26 may be provided in a number of ways. In a first option, the sheath 12 itself forms the leading end 26, by suitable heat treatment, for example using a soldering iron or by pressing the sheath 16 (following heat-shrinking onto the spring 12) against a hot plate (not shown). Alternatively and as shown in FIG. 3, an end 34 of the spring 12 may be tapered, by suitable shaping of coils 22 of the spring, to define the tapered leading end 26. The sheath 16 is then heat shrunk around the spring, including its end 34.

[0108] FIG. 5 is a side view of a medical probe in accordance with an alternative embodiment of the present invention, indicated generally by numeral 100, and which is again provided as a fistula probe. Like components of the probe 100 with the probe 10 of FIGS. 2 and 3 share the same reference numerals, incremented by 100. Only the substantial differences between the probe 100 of FIG. 5 and the probe 10 of FIG. 2 will be described in detail.

[0109] The probe 100 of FIG. 5 illustrates an alternative method of forming a leading end 126. In this embodiment, a separate end component 36 is coupled to a spring 112 of the probe 100, the end component 36 being shaped so as to form the tapered leading end 126. The end component 36 may be of any suitable material including plastics and metals, and can have a number of different shapes. In the illustrated embodiment, the end component is hemispherical. The end component 36 can also be secured in a number of different ways. In one example, the end component 36 is secured to the spring 112 using an adhesive. A sheath 116 may extend around the end component 36 to provide further securement. Alternatively, the sheath 116 may extend up to a junction 38 between the end component 36 and the spring 112.

[0110] Alternative shapes for the end component 36 include spherical, conical, truncated conical, rounded and generally bullet-shaped or bulleted. In addition, the end component 36 may be located in position at the leading end 126 by inserting part of the end component 36 into a bore 40 of the spring 112. For example, the end component 36 may have a projection (not shown) which is received in an end of the bore 40 for locating it in position.

[0111] Returning to FIG. 2, the fistula probe 10 (and indeed the probe 100) may be adapted to cooperate with, and may comprise, a treatment element 42, suitably in the form of a flexible elongate treatment element. In the illustrated embodiments, the flexible elongate treatment element 42 is a seton. The seton 42 can take different forms, but in the embodiment of FIG. 2, comprises a surgical thread, cord or alternatively a single filament. The seton 42 is secured to the probe 10 via the coupling feature 24, which in this embodiment takes the form of an eyelet. The probe 10 draws the seton 42 into the fistula tract 3, and can then be released from the seton 42 leaving it in place within the tract 3. The seton 42, once in place within the tract 3, may serve for maintaining the tract open. This may facilitate one or more of: drainage of the tract; the supply of treatment materials into the tract; and may provide a preparatory step to a surgical procedure to treat the fistula. Optionally, the seton 42 is a cutting seton which is formed into a loop and tensioned to apply pressure to surrounding tissue, so as to slowly cut through the body tissue and exteriorise the fistula tract 3.

[0112] As also shown in FIG. 2, the probe 10 can optionally include, or cooperate with, a cleaning tool 44. The cleaning tool 44 can take many forms, but in the illustrated embodiment takes the form of a brush. The brush 44 may be attached to the probe 10 via the seton 42, which is secured to the eyelet 24. The brush 44 may be used to clean the tract 3, in particular to remove infected material, puss, and/or epithelialised tissue. The eyelet 24 may be provided separately and secured to the spring 12, such as using a suitable adhesive. Alternatively, a coil or coils (not shown) of the spring 12 may be shaped (e.g. twisted) away from a main part of the spring to define the eyelet 24.

[0113] Turning now to FIG. 7, there is shown a medical probe in accordance with another embodiment of the present invention, the probe indicated generally by reference numeral 200, again provided as a fistula probe. Like components of the probe 200 with the probe 100 of FIG. 5, or the probe 10 of FIG. 2, share the same reference numerals incremented by 200 or 100, as appropriate. Again, only the substantial differences between the probe 200 and the probes 10, 100 will be described in detail.

[0114] The probe 200 shown in FIG. 7 is essentially of similar construction to the probe 10 shown in FIG. 2, save that a sheath 216 extends beyond an end of a spring 212 of the probe, which is shown in the longitudinal sectional view of FIG. 8, an end 44 of the spring 212 being shown in the drawing.

[0115] One difference between the probe 200 shown in FIG. 7 and those of FIGS. 2 and 5 are that the probe 200 comprises or is employed with a different type of seton, the seton indicated by reference numeral 242. In this embodiment, the seton 242 is tubular along its entire length, and typically formed of an elastomeric material. The elastomeric material may suitably be an inert silicone elastomer, such as that commercially available from Dow Corning Corporation in the USA under the SILASTIC trade mark. An internal diameter of the sheath 216 is selected to be larger than an internal diameter of the tubular seton 242. In this way, the seton 242 can be located within the second portion 48 of the sheath, which effectively acts as a tail to the probe 200.

[0116] In this embodiment, the sheath 216 is again heat-shrunk onto the spring 12. Heat is only applied to a first portion 46 of the sheath 216 which extends along (and so covers) the spring 212, and a short distance along a length of the seton 242. This acts to shrink the sheath 216 into close contact with the spring 212, but also into contact with the seton 242, to grip and so retain the seton. A second portion 48 of the sheath 216, which covers a main part of the seton 242, remains substantially or entirely undeformed. The second portion 48 thus has a larger internal diameter than the effective internal diameter of the first portion 46, which has been heat-shrunk onto the spring 212 and part of the seton 242. In a variation on this embodiment, the sheath 216 may be heat-shrunk along its entire length, to grip the seton 242 along the entire length of the portion of the sheath which receives the seton.

[0117] In use, a leading end 226 of the probe 200 is inserted into and along the fistula tract 3, the second portion (or tail) 48 of the sheath 216 carrying the tubular seton 242 into the tract. The leading end 226 is passed out of the tract 3 through an interior opening 52 and withdrawn through the anal canal 4, drawing a leading end 50 of the seton 242 out of the tract 3. The sheath 212 can be released from the seton 242, by grasping a trailing end 54 of the seton 242 (positioned outside of the body), and then pulling the probe 200 to slide the second portion 48 of the sheath 212 over the seton 242.

[0118] The probe 200 of FIG. 7 is shown incorporating a coupling feature, which once again may take the form of an eyelet 24. The eyelet 24 may be employed for coupling an alternative seton, such as the seton 42 shown in FIG. 2, to the probe. It will be understood that this would typically need to be carried out prior to positioning the sheath 216 over the spring 212 and heat-shrinking the sheath. Alternatively, the coupling eyelet may be dispensed with.

[0119] In variations on the embodiment illustrated in FIG. 7, the seton 242 may have a different structure. For example, the seton may have a solid cross-section, or may be substantially solid with open leading and trailing ends 50, 54.

[0120] Turning now to FIG. 9, there is shown a medical probe in accordance with another embodiment of the present invention, the probe indicated generally by reference numeral 300, and again provided as a fistula probe. Like components of the probe 300 with the probes 10, 100 and 200 of FIGS. 2, 5 and 7 share the same reference numerals incremented by 300, 200 or 100, as appropriate. Again, only the substantial differences between the probe 300 and the probes 10, 100 and 200 will be described in detail.

[0121] The probe 300 shown in FIG. 9 is of similar construction to the probe 200 shown in FIG. 7, comprising a spring 312 and a sheath 316 which receives a tubular seton 342, that again may be of a silicone elastomer material. The probe 300 comprises a different leading end 326, having a spherical end component 336, typically in the form of a ball bearing. The ball bearing 336 is typically coupled to the spring 312 using an adhesive, illustrated at 49 in the drawing, the sheath 316 extending up and over the a junction 338 between the ball 336 and the spring 312.

[0122] The probe 300 also comprises a support element 51, in the form of a plug, which is adapted to be located within a tubular leading end 50 of the seton 342. The plug 51 supports the seton 342 internally, where the sheath 316 is deformed into contact with it. This resists collapse of the tubular seton 342, promoting frictional contact between the sheath 316 and the seton 342, and so gripping of the seton by the sheath. Following location of the seton 342 within the fistula tract 3, the sheath 316 and the seton 342 may be severed at a location which is between the plug 51 and a trailing end 328 of the sheath 316. The plug 51 typically has an external diameter which is larger than an internal diameter of the seton 342. This acts to deform the seton 342 outwardly, promoting contact with the sheath 316.

[0123] In all of the embodiments described above, the seton, once located within the fistula tract, may be formed into a loop and secured in place. This may be achieved by tying a part of the seton protruding from the exterior opening of the tract to a part protruding from the interior opening, suitably using a knot. Alternatively, and where the seton is formed from a suitable material, the parts of the seton may be fused together, e.g. by the application of heat. A further alternative option will be described with reference to FIGS. 10 to 14.

[0124] Thus turning now to FIG. 10, the flexible tubular seton 242 is shown in more detail. It will be understood from the foregoing description that the seton 342 is of like construction, and so that the following applies equally to the seton 342. Whilst the seton 242 may form part of, or be used with, any of the probes 10, 100, 200 and 300 described above, the seton may form part of a seton assembly for use in treating a tract (in particular a fistula) which has a use without the probes disclosed herein. The following discussion therefore applies both to a seton forming part of the disclosed probes 10, 100, 200 and 300 (or which can be used with them), or which can be used separately.

[0125] Thus FIG. 10 shows a seton assembly 56 which comprises the seton 242 and a connecting element 56. The connecting element is insertable into first and second ends of the seton 242, which in this case are the leading end 50 and the trailing end 54. This is best shown in the enlarged schematic view of FIG. 10, which shows the connecting element 56 located in the trailing end 54 of the seton 242. The connecting element 56 takes the general form of a plug or plug-like element. The connecting element 56 may provide an interference fit within the ends 50, 54 of the seton 242, suitably by providing the plug 56 with a larger external diameter than an internal diameter of the seton 242.

[0126] The connecting element 56 is suitably secured using an adhesive which, where the seton 242 is of a silicone elastomer (such as SILASTIC) material, may be a dedicated silicone elastomer adhesive. The seton 242 is shown formed into a loop, which is the shape that it would adopt following introduction into the fistula tract 3 using a fistula probe, and withdrawal of the leading end 50 down the anal canal 4 and through the anus 9 of the patient.

[0127] As shown in FIG. 11, the natural flexibility and resilience of the silicone elastomer material forming the seton 242 enables the leading end 50 to be folded back upon itself, so that the connecting element 56 can be inserted into an opening 58 which is then formed. Again, a suitable adhesive may be used to secure the connecting element 56 within the leading end 50 of the seton 242. This is shown in FIG. 12, where a first portion 60 of the connecting element 56 is located within the trailing end 54 of the seton 242, and a second portion 62 of the connecting element 56 is located in the leading end 50.

[0128] A portion 64 of the seton 242 at the leading end 50 which has been rolled back is then folded back over the first portion 60 of the connecting element 56, as shown in FIG. 13. This continues until the portion 64 that has been rolled back has been frilly extended, as shown in FIG. 14, where it extends beyond the trailing end 54 of the seton 242 and the connecting element 56.

[0129] The connecting element 56 may comprise anchoring elements for anchoring it to the seton 242. For example, the connecting element 56 may comprise barbs or teeth (not shown) which extend from a main body of the element, for engaging the seton 242.

[0130] Turning now to FIG. 15, there is shown a side view of a medical probe in accordance with a further embodiment of the present invention, the probe indicated generally by reference numeral 400, and again provided as a fistula probe. The probe 400 is also shown in FIG. 16, sectioned about line A-A in FIG. 15. Like components of the probe 400 with the probes 10, 100, 200 and 300 of FIGS. 2, 5, 7 and 9 share the same reference numerals incremented by 400, 300, 200 or 100, as appropriate. Again, only the substantial differences between the probe 400 and the probes 10, 100, 200 and 300 will be described in detail.

[0131] The probe 400 comprises an elongate elastically deformable member in the form of a spring 412, which again comprises a helically wound element. The probe 400 also comprises a sheath 416 having an inner surface 418 which contacts an outer surface 420 of the spring 412. In this embodiment, the sheath 416 extends from a leading end 426 of the spring 412 part way along a length of the spring, and assists in insertion of the probe 400 into the fistula tract 3. The sheath 416 may extend any desired distance along a length of the spring 412. In the illustrated embodiment, the sheath 416 extends only a short distance (typically between 0.5 cm and 3 cm) along the length of the spring 412. A lead-most part 432 of the sheath 416 is rounded or bulleted to facilitate insertion and passage along the tract 3, in the fashion described above, although any of the other techniques disclosed herein may be employed to form a tapered nose on the probe.

[0132] The probe 400 also comprises a treatment element, suitably a hollow flexible elongate treatment element in the form of a hollow seton 442. Again, the seton 442 may be of a silicone elastomer or other suitable material. The seton 442 extends over the outer surface 420 of the spring 412, and may effectively form part of a sheath of the probe. As will be understood from the drawing, the sheath 416, and the sheath formed by the seton 442, are separate and spaced apart. The seton 442 is arranged to engage the spring 412 in an interference fit, suitably by providing the seton with an internal diameter which is smaller than an external diameter of the spring.

[0133] As best shown in FIG. 16, the spring 412 has a first portion 66 which is of a first diameter D.sub.1, and a second portion 68 of a second diameter D.sub.2, the second diameter being smaller than the first diameter. The spring 412 tapers from the first diameter D.sub.1 to the second diameter D.sub.2 at an intersection region 70. The hollow seton 442 is arranged to engage the second portion 68 of the spring 412, and is arranged so that it does not extend over the intersection region 70 and on to the first portion 66. As can be seen from the drawings, an external diameter D.sub.3 of the seton 442 is substantially the same as (and optionally the same as) the first diameter D.sub.1, at least prior to location of the seton over the second portion 68 of the spring 412. In this way, any ledge or shelf between the first portion 66 of the spring 412 and a leading end 50 of the seton 442 is minimised. This may facilitate entry of the probe 400 into the tract 3, and passage along the tract.

[0134] The probe 400 also comprises a further treatment element, suitably a flexible elongate treatment element, which is again a seton but which takes the form of a suture 442a, such as a surgical thread. The suture 442a is adapted to be coupled to the spring 412 via the hollow seton 442. This is achieved by locating the suture 442a within an internal cavity 72 defined by the seton 442, and then either: passing the suture 442a into and along an internal cavity 74 defined by the spring 412 (as shown in FIG. 16); or trapping the suture 442a between an inner surface 76 of the hollow seton 442 and the outer surface 420 of the spring 412 in the region of the second portion 68 (as shown in. FIG. 17). Either method serves for capturing the suture 442a so that it can be drawn into the fistula tract 3 with the spring 412.

[0135] Once located within the fistula tract 3, the hollow seton 442, with the suture 442a located within it, can be separated from the spring 412 leaving them in place within the tract. An interference fit between the hollow seton 442 and the reduced diameter portion 68 of the spring 412 is such that there is sufficient friction to draw the seton into the tract 3, but the fit still allows easy separation from the spring 412 when required. This is achieved simply by holding on to a trailing end 54 of the seton 442 which protrudes from the exterior opening of the fistula tract 3. Whilst pulling on the spring 412 and removing it from the body through the anal canal 4. The ends 50 and 54 of the seton 442 are then brought together to form a loop, and ends 50 and 54 of the suture 442a tied together in a knot (not shown) to hold the hollow seton in the loop shape. Suitably, the knot may subsequently be manoeuvred to a location within the cavity 72 of the hollow seton 442, to improve patient comfort. Once formed into a loop, the seton 442 (and associated suture 442a) maintain the tract 3 open for drainage and other purposes, as described above.

[0136] In a variation on the probe 400 shown in FIG. 15, the sheath 416 on the leading end 426 may be dispensed with. Tests on probes manufactured according to the principles of the present invention have shown that the probes can work adequately without a sheath extending over an entire length of the spring, and indeed over a leading end of the probe (in particular the leading end of the spring). Factors impacting upon a decision as to whether to dispense with the sheath, in particular on a leading end of the probe, include: a diameter of the probe; a pitch of the spring (and so dimensions of any gaps between adjacent turns of the spring, which may only open up when the probe is deformed during passage along a fistula tract); and materials chosen to form the spring (and in particular their coefficient of friction).

[0137] The medical probe of the present invention has been described with particular reference to a fistula probe, intended for traversing a fistula tract. It will be appreciated however that the probe has other uses within the medical field, in particular for traversing other tracts in the body, including but not restricted to a tendon or ligament sheath, as well as tracts forming part of the vascular system such as arteries and veins. Any of the medical probes, assemblies comprising medical probes, treatment elements and methods described herein may have a use in further procedures, such as the traversal and/or treatment of such further tracts, and the performance of steps in methods which involve passing the probe into/along any such tracts.

[0138] Various modifications may be made to the foregoing without departing from the spirit or scope of the present invention.

[0139] For example, the sheath may be formed from an elongate element which is helically wound on to the elastically deformable member so as to cover the member, and which may be an elongate wrapping element. The elongate element may comprise a tape, strap or strip. Successive turns of the helically wound elongate element may overlap a preceding turn.