Fixation system

Abstract

A fixation system (1) for fixation of a medical device (2) through an anatomical wall in a human or animal patient, the fixation system comprising an inflatable fixation element (4) adapted to be inflated in a position relative to the device to substantially prevent movement of the device in a given direction relative to the anatomical wall, and means (11) for varying the position of inflation of the inflatable fixation element relative to the device, to account for variability in the thickness of the anatomical wall.

Description

[0001] Fixation System

[0002] The present invention relates to a fixation system comprising means to compensate for the variability of the thickness of a wall of a biological structure of a patient, and a medical device including such a fixation system.

[0003] Many types of medical device are intended for insertion through a body wall of a patient, for example, through the wall of an organ or tissue of a patient to provide an access point. Once the medical device has been inserted through the wall, the device is typically fixed in place using, for example, an external and / or internal flange so that it does not move unintentionally, since such movement of the device may cause problems, for example, during a medical procedure.

[0004] It is known to provide a fixation element as a part of a medical device itself, to hold the medical device in position. For example, a flange may be provided on a tracheostomy tube to hold the tube in place when it has been inserted into a patient. Sometimes two fixation elements are provided, for example where fixation of the medical device is accomplished through compression of a body wall between an internal and external fixation element of the device. However, the position of the internal and external elements relative to one another is fixed or has a limited range of adjustment, whereas the thickness of the body cavity walls of patients will vary depending on the anatomy of the patient. Thus, it is difficult to achieve secure fixation of the medical device in such cases without a range of different sizes of device, which is inconvenient for the clinician and can add expense.

[0005] The present invention seeks to ameliorate problems associated with the prior-art described above.

[0006] According to a first aspect of the invention, there is provided a fixation system for fixation of a medical device through an anatomical wall in a human or animal patient, the fixation system comprising an inflatable fixation element adapted to be inflated in a position relative to the device to substantially prevent movement of the device in a given direction relative to the anatomical wall, and means for varying the position of inflation of the inflatable fixation element relative to the device, to account for variability in the thickness of the anatomical wall. Advantageously, the fixation system may be used to account for variability of the thickness of anatomical walls such as the abdominal wall of a patient, or the thickness of an organ or tissue of a patient.

[0007] Preferably, the means for varying the position of inflation of the inflatable fixation element comprises a constricting device that is adapted to constrict a part of the inflatable element. The constricting device may comprise a tube, a band or a clip, in each case being dimensioned to partially fit over the inflatable element before the element is inflated.

[0008] Preferably, when the constricting device comprises a tube, the tube takes the form of a sleeve that is dimensioned to be slidable over a part of the inflatable fixation element when it is uninflated.

[0009] Preferably, the inflatable fixation element when inflated provides a first flange to substantially prevent movement of the device in a given direction relative to the anatomical wall in the inflated condition. It is further preferred that the flange so provided comprises an inner flange relative to the anatomical wall, wherein the position of the inner flange varies depending on the length of the sleeve. In a further embodiment the system may comprise a second flange, preferably an outer flange, thus preventing movement in two given directions. Alternatively, the first or second flange may be provided by an additional structure, such as the medical device or associated apparatus itself. Preferably, the inflatable fixation element comprises a balloon. Advantageously, the variable position of the inner flange with respect to the sleeve and balloon allows the system to accommodate different thicknesses of a patient’s body cavity wall and thus hold the fixation system in position.

[0010] Preferably, the sleeve is sized to tailor the position of the flange according to the thickness of a body cavity wall of the patient.

[0011] Typically, the sleeve length may be varied to vary the position of inflation of the balloon relative to a body cavity wall of the patient. In one embodiment, the sleeve may be provided with index marks such that it may be cut to a length suitable to tailor the position of the flange according to the thickness of a body cavity wall of the patient. In an alternative embodiment, the sleeve may be provided with lines of weakness to allow a user to modify it without the use of tools to tailor it to a desired length. In another embodiment, the sleeve may be sufficiently flexible for it to be rolled upon itself to thereby vary its length relative to the body cavity wall of the patient.

[0012] Alternatively, in another embodiment, a plurality of position varying means may be provided to accommodate different body cavity wall thicknesses of a patient, such as a plurality of sleeves of different lengths.

[0013] Preferably, the balloon is inflated at a distal end of the sleeve. Preferably, the sleeve is shaped and dimensioned to assist in accommodating inflation of the balloon. In particular, the distal end of the sleeve from which the balloon extends upon inflation may be shaped to guide the direction and / or extent of inflation, as, for example, by being flared or tapered.

[0014] Preferably, the sleeve and / or the balloon comprises a plastics material. In one embodiment, the sleeve and / or balloon may comprise PVC or silicone. Preferably, the sleeve and / or balloon may comprise a rigid and / or flexible material. In one embodiment, the sleeve and balloon comprise the same material. In another embodiment, the sleeve and balloon comprise different materials. In one embodiment, the sleeve and balloon comprise a combination of materials, wherein the materials of the sleeve and balloon may assist in generating a soft transition from the sleeve to the balloon on inflation of the balloon, providing an angle of inflation that is less traumatic to a patient. Preferably, the sleeve and / or balloon comprise a material such that, on inflation of the balloon, the angle of inflation of the balloon is adapted to an angle as desired by a particular procedure. Preferably, the angle of inflation of the balloon may be adapted to provide a smooth transition between the sleeve and balloon as the balloon is inflated. In one embodiment, the sleeve may act as a wedge that may allow for ease of inflation of the balloon.

[0015] In one embodiment, the fixation system further comprises an access way to provide access through the anatomical wall of the patient. In one embodiment, the access way may comprise a tube. Where the access way comprises a tube, the tube may include a fixed position flange to prevent movement of the tube in a given direction relative to the anatomical wall.

[0016] According to a second aspect of the invention, there is provided a medical device comprising a fixation system according to the first aspect. In one embodiment, the medical device is a catheter. In one embodiment, the catheter is a peritoneal catheter.

[0017] Preferably, the catheter comprises an elongate tube comprising a proximal end and a distal end, wherein the distal end is the end of the tube that is closest to the patient.

[0018] Advantageously, the sleeve and balloon assist in securing and holding the catheter in place when it is being used, for example, in the process of dialysis, thus avoiding movement of the catheter which may disrupt the process of dialysis and reduce the efficiency thereof. In addition, securing the device in position during a procedure such as dialysis may reduce the risk of infection to the patient.

[0019] In one embodiment, the elongate tube comprises a tip having an open end. Preferably, the tube comprises a tip fixation means.

[0020] In another embodiment, the tube comprises an integrated tungsten tip. Advantageously, the provision of an integrated tungsten tip provides a weight at the end of the catheter that is inserted into a patient such that the system may be positioned and held at the bottom most part of the cavity where the elongate tube is placed.

[0021] Preferably, the catheter comprises an elongate cylindrical wall, the wall defining a central lumen there being a plurality of holes known as ports allowing fluid communication between the central lumen and the exterior of the catheter. It is further preferred that the catheter wall defines a secondary longitudinally extending lumen, the wall defining a further plurality of holes known as ports allowing fluid communication between the secondary lumen and the exterior of the catheter.

[0022] Preferably, the plurality of holes comprises at least one aspiration hole and at least one irrigation hole. In one embodiment, the elongate tube comprises three irrigation holes and one aspiration hole. In another embodiment, the elongate tube comprises three irrigation holes and a plurality of aspiration holes. In one embodiment, a plurality of holes may be provided along the length of the catheter, wherein the holes may be provided with a small diameter. Advantageously, the provision of a plurality of holes along the length of the catheter with a small diameter may prevent irrigation lumen damage. Preferably, the wall further comprises a corrugated and / or indented section. Preferably, the corrugated and / or indented section comprises a plurality of holes. Preferably, the corrugated and / or indented section comprises one or more aspiration holes. Advantageously, the provision of a corrugated and / or indented section prevents the aspiration holes from sucking onto organs.

[0023] Preferably, the balloon may be adhered or welded to the outer wall of the elongate tube. In another embodiment, the balloon may be attached to the outer wall of the elongate tube by another fixing means.

[0024] Typically, the device comprises a connector at the proximal end of the elongate tube.

[0025] In one embodiment, the connector is integral with the elongate tube.

[0026] Preferably, the connector comprises means for attachment to an air supply. In one embodiment, the connector may be sealed with a plug.

[0027] Preferably, the connector comprises a central conduit in communication with the elongate tube. Preferably, the connector further comprises two arm portions that may extend from the conduit at an angle that is substantially perpendicular to the axis of the conduit. Preferably, the connector comprises irrigation means, aspiration means and air inlet means, wherein the air inlet means allows for the passage of air into the system and thus to the balloon. Preferably, the air inlet means comprises a button inlet for attachments. In one embodiment, the air inlet means comprises a built-in one-way valve.

[0028] In one embodiment, the device may be coated and / or embedded with an antibacterial, antimicrobial and / or cytostatic coating. In one embodiment, the device may be coated with antiseptic silver ions. Advantageously, the provision of a device that is coated and / or embedded with an antibacterial or antimicrobial coating reduces the risk or bacterial or microbes being introduced to the patient during a procedure using the system of the invention. Advantageously, the provision of a device that is coated and / or embedded with a cytostatic coating provides an anti-cancer treatment that reduces the number of cancer cells within the patient. Advantageously, the provision of a device that has been coated and / or embedded with an antibacterial, antimicrobial and / or cytostatic coating adds a barrier to prevent bacteria or microbes from entering the device.

[0029] According to a third aspect, there is provided a method of treating a patient including the step of fixing a medical device in a body cavity wall, wherein the device includes a fixation system according to the first aspect.

[0030] According to a fourth aspect, there is provided a kit comprising a fixation system according to the first aspect and an air supply.

[0031] The invention will now be further described by way of example and with reference to the accompanying drawings, in which:

[0032] Figure 1 is a schematic view of a fixation system in accordance with an embodiment of the invention;

[0033] Figure 2 is a schematic view of a further fixation system according to an embodiment of the invention;

[0034] Figure 3 is a schematic view of a fixation system according to another embodiment of the invention;

[0035] Figure 4a and Figure 4b show a partial end view of a fixation system according to an embodiment of the invention;

[0036] Figure 5a is a schematic view of an embodiment of the invention wherein the fixation system comprises a balloon in a non-inflated position;

[0037] Figure 5b is a schematic view of an embodiment of the invention wherein the fixation system comprises a balloon in an inflated position; and

[0038] Figure 5c is a schematic view of another embodiment of the invention, wherein the fixation system comprises a balloon in an inflated position. With reference to the figures, there is provided a fixation system 1 for fixation of a medical device 2 through an atomical wall in a human or animal patient, the system comprising an inflatable fixation element 4 adapted to be selectively inflated and deflated in a position relative to the device, to substantially prevent movement of the device relative to the anatomical wall in the inflated condition, and means 11 for varying the position of inflation of the element, relative to the device to account for the thickness of the anatomical wall. Figures 1 to 5 show the invention provided as a part of a medical device, in this case, a peritoneal catheter of a generally known type to a suitably skilled person.

[0039] Referring firstly to Figures 1 to 5, the catheter comprises an elongate tube 6 comprising a proximal end and a distal end, wherein the distal end is the end of the tube that is intended for insertion into the patient. In the embodiment shown in Figure 1, at the distal end the elongate tube 6 comprises an open tip 18 having a tip fixation loop 20. In this embodiment, the tip fixation loop comprises a suture string.

[0040] With reference to Figures 2 and 3, the elongate tube 6 comprises an integrated tungsten tip 22. Advantageously, the provision of an integrated tungsten tip provides a weight at the distal end of the catheter, i.e. the end that is inserted into a patient such that the system may be positioned and held at the lower most part of the cavity where the elongate tube is placed. In one embodiment, the tungsten weighted tip may comprise a 0.038 inch (approximately 0.9 mm) aperture for passage of a guide wire. In the embodiment shown in Figures 2 and 3, no suture string is provided.

[0041] With reference to the figures, the means for varying the position of inflation of the inflatable fixation element 4 comprises a constricting device that is adapted to constrict a part of the inflatable element. The constricting device comprises a tube that is dimensioned to partially fit over the inflatable element before the element is inflated. The tube takes the form of a sleeve 11 that is dimensioned to be slidable over a part of the inflatable fixation element when it is uninflated.

[0042] The catheter further comprises a central lumen and a wall having a plurality of holes known as ports 14, 16 along its length. With reference to Figure 1, the catheter comprises three irrigation holes 14 and one aspiration hole 16. With reference to Figures 2 and 3, the catheter comprises three irrigation holes 14 and a plurality of aspiration holes 16. In the embodiment shown in Figure 2, a plurality of aspiration holes is provided, each hole having a small diameter so as to prevent irrigation lumen damage to the catheter.

[0043] In the embodiment shown in Figure 3, the wall further comprises a corrugated and / or indented section 32, wherein the corrugated and / or indented section comprises a plurality of aspiration holes. Advantageously, the provision of a corrugated and / or indented section prevents the aspiration holes from sucking onto organs.

[0044] The inflatable fixation element 4 when inflated provides a first flange to substantially prevent movement of the device in a given direction relative to the anatomical wall in the inflated condition. The flange so provided comprises an inner flange 10 relative to the anatomical wall, wherein the position of the inner flange varies depending on the length of the sleeve. The system may also comprise a second flange 15, thus preventing movement in two given directions, wherein the second flange is an outer flange.

[0045] With reference to the figures, the inflatable fixation element comprises a balloon 4. The sleeve length may be varied to vary the position of inflation of the balloon relative to a body cavity wall of the patient. The sleeve may be sized to tailor the position of the flange according to the thickness of a body cavity wall of the patient. Advantageously, the variable position of the inner flange 10 with respect to the sleeve 11 and balloon 4 allows the system to accommodate different thicknesses of a patient’s body cavity wall and thus hold the fixation system 1 in position.

[0046] With reference, for example, to Figures 2 and 3, the sleeve 11 has a length (Lt) of 150 mm, The length of the balloon (Lb) is 100 mm and the diameter of the balloon (0b) is 20 mm. L* relates to the length of the portion of the catheter between the connector to the beginning of the balloon and in this embodiment L* is 10 mm. In one embodiment, the diameter of the sleeve is 14 Fr (i.e. 4.66 mm). The sleeve length may be varied to vary the position of inflation of the balloon relative to a body cavity wall of the patient. In the embodiment shown in Figures 2 and 3, the sleeve is provided with index marks such that it may be cut to a length suitable to tailor the position of the flange according to the thickness of a body cavity wall of the patient.

[0047] In this embodiment, the sleeve may be cut to a length that is L* + 5 mm.

[0048] In the embodiment wherein the sleeve 11 is cut such that it has a length that is the same size of a body cavity wall of the patient this has the advantage that the system will be able to fit all sizes of patient. In another embodiment, the sleeve 11 is provided in a range of fixed lengths and a user can select an appropriate length of tube depending on the thickness of the body cavity wall of a patient. In the above embodiments, the clinician assesses the required size of sleeve 11 according to where the flange is to be provided by the balloon and either cuts or selects a sleeve to the correct length.

[0049] In another embodiment, a plurality of position varying means may be provided to accommodate different body cavity wall thicknesses of a patient, such as a plurality of sleeves of different lengths.

[0050] The balloon 4, elongate tube 6 and / or the sleeve 11 typically comprise a plastics material, such as PVC or silicone. Typically, the sleeve and / or balloon comprise a material such that, on inflation of the balloon, the angle of inflation of the balloon is adapted to an angle as desired by a particular procedure. The angle of inflation of the balloon is adapted to provide a smooth transition between the sleeve and balloon as the balloon is inflated.

[0051] The balloon may be adhered or welded to an outer wall of the elongate tube or may be attached to the outer wall of the elongate tube by another fixing means.

[0052] As shown in Figures 1 to 3, the device comprises a connector 12 at the proximal end of the elongate tube. In one embodiment, the connector 12 is integral with the elongate tube. With reference to Figure 1, the connector may be sealed with a plug and the connector 12 comprises a central conduit 12a in communication with the elongate tube. The central conduit is typically used for aspiration of fluid and / or gases from the elongate tube, allowing for the removal of liquid from the system. The connector further comprises two arm portions 12b, 12c that extend from the conduit at an angle that is substantially perpendicular to the axis of the conduit. The arm 12b provides an air inlet means that allows for the entry and passage of air into the system, thus providing air to inflate the balloon. The arm 12b comprises a button inlet 24 for attachments to the connector. The arm 12b may comprise a built-in one-way valve. The arm 12c provides an irrigation means for the system, allowing for the addition of liquid to the system.

[0053] The fixation system 1 further comprises an access way to provide access through the anatomical wall of the patient, in this instance, this is the catheter tube. The connector 12 of the tube provides the fixed position flange (15) to prevent movement of the tube in a given direction relative to the anatomical wall.

[0054] The device 2 may be coated and / or embedded with an antibacterial, antimicrobial and / or cytostatic coating. In one embodiment, the device may be coated with antiseptic silver ions. In one embodiment, the device may be coated with antibacterial and / or antiseptic additives. Advantageously, the provision of a system that is coated and / or embedded with an antibacterial or antimicrobial coating reduces the risk or bacterial or microbes being introduced to the patient during a procedure using the system of the invention. Advantageously, the provision of a system that is coated and / or embedded with a cytostatic coating provides an anti-cancer treatment that reduces the number of cancer cells within the patient.

[0055] With reference to the figures, there is also provided a method of treating a patient including the step of fixing a medical device 2 in a body cavity wall, wherein the device includes a fixation system 1. With reference to the figures, there is also provided a kit comprising a fixation system 1 and an air supply.

[0056] Figures 4a and 4b show a partial view of a medical device of the invention showing the sleeve 11 and balloon 4.

[0057] Figures 5a and 5b are schematic views of an embodiment of the invention and are provided to graphically illustrate its functioning. In Figure 5a, the fixation system is shown with its balloon in a non-inflated position and no sleeve as yet applied. Figure 5b is shows the fixation system balloon in the inflated position, with sleeve 11 placed such that the position of the inner flange is appropriate for the thickness of the body wall as ascertained by a clinician. In the alternative embodiment of Figure 5c, a fixation system is shown which comprises a balloon and sleeve that together define both the inner and outer flanges. In use, in the inflated configuration the balloon 4 provides a variable position inner flange 10, the position of which can be tailored to the thickness of a patient’s anatomical wall and thus hold the access way in position. In use, a clinician will assess the thickness of the anatomical wall to be traversed and will either cut or choose a sleeve of appropriate length. The sleeve is placed over the balloon and the catheter is inserted such that inflation of the balloon creates a flange at the desired position.

Claims

CLAIMS1. A fixation system for fixation of a medical device through an anatomical wall in a human or animal patient, the fixation system comprising an inflatable fixation element adapted to be inflated in a position relative to the device to substantially prevent movement of the device in a given direction relative to the anatomical wall, and means for varying the position of inflation of the inflatable fixation element relative to the device, to account for variability in the thickness of the anatomical wall.

2. A fixation system according to claim 1, wherein the means for varying the position of inflation of the inflatable fixation element comprises a constricting device that is adapted to constrict a part of the inflatable element.

3. A fixation system according to claim 2, wherein the constricting device comprises a tube, a band or a clip, in each case being dimensioned to partially fit over the inflatable element before the element is inflated.

4. A fixation system according to claim 3, wherein when the constricting device comprises a tube, the tube takes the form of a sleeve that is dimensioned to be slidable over a part of the inflatable fixation element when it is uninflated.

5. A fixation system according to any preceding claim, wherein the inflatable fixation element when inflated provides a first flange to substantially prevent movement of the device in a given direction relative to the anatomical wall in the inflated condition.

6. A fixation system according to claim 5, wherein the flange comprises an inner flange relative to the anatomical wall, wherein the position of the inner flange varies depending on the length of the sleeve.

7. A fixation system according to claim 5 or 6, wherein the system comprises a second flange.

8. A fixation system according to claim 7, the second flange is an outer flange.

9. A fixation system according to any one of claims 5 to 8, wherein the first or second flange is provided by an additional structure, such as the medical device or associated apparatus itself.

10. A fixation system according to any preceding claim, wherein the inflatable fixation element comprises a balloon.

11. A fixation system according to any one of claims 4 to 10, wherein the sleeve length is varied to vary the position of inflation of the balloon relative to a body cavity wall of the patient.

12. A fixation system according to any one of claims 4 to 11, wherein the sleeve is sized to tailor the position of the flange according to the thickness of a body cavity wall of the patient.

13. A fixation system according to claim 11 or 12, wherein the sleeve is provided with index marks such that it is cut to a length suitable to tailor the position of the flange according to the thickness of a body cavity wall of the patient.

14. A fixation system according to claim 11 or 12, wherein the sleeve is provided with lines of weakness to allow a user to modify it without the use of tools to tailor it to a desired length.

15. A fixation system according to claim 11 or 12, wherein the sleeve is sufficiently flexible for it to be rolled upon itself to thereby vary its length relative to the body cavity wall of the patient.

16. A fixation system according to any preceding claim, wherein plurality of position varying means is provided to accommodate different body cavity wall thicknesses of a patient, such as a plurality of sleeves of different lengths.

17. A fixation system according to any one of claims 10 to 16, wherein the balloon is inflated at a distal end of the sleeve.

18. A fixation system according to claim 17, wherein the sleeve is shaped and dimensioned to assist in accommodating inflation of the balloon.

19. A fixation system according to claim 18, wherein the end of the sleeve from which the balloon extends upon inflation is shaped to guide the direction and / or extent of inflation, as, for example, by being flared or tapered.

20. A fixation system according to any one of claims 10 to 19, wherein the sleeve and / or the balloon comprises a plastics material.

21. A fixation system according to claim 20, wherein the sleeve and / or balloon comprises PVC or silicone.

22. A fixation system according to any one of claims 10 to 21, wherein the sleeve and balloon comprise the same material.

23. A fixation system according to any one of claims 10 to 21, wherein the sleeve and balloon comprise different materials.

24. A fixation system according to any one of claims 10 to 21, wherein the sleeve and balloon comprise a combination of materials, wherein the materials of the sleeve and balloon assist in generating a soft transition from the sleeve to the balloon on inflation of the balloon, providing an angle of inflation that is less traumatic to a patient.

25. A fixation system according to any one of claims 10 to 24, wherein the sleeve and / or balloon comprise a material such that, on inflation of the balloon, the angle of inflation of the balloon is adapted to an angle as desired by a particular procedure.

26. A fixation system according to claim 25, wherein the angle of inflation of the balloon is adapted to provide a smooth transition between the sleeve and balloon as the balloon is inflated.

27. A fixation system according to any one of claims 10 to 26, wherein the sleeve acts as a wedge that allows for ease of inflation of the balloon.

28. A fixation system according to any preceding claim wherein the fixation system further comprises an access way to provide access through the anatomical wall of the patient.

29. A fixation system according to claim 28, wherein the access way comprises a tube.

30. A fixation system according to claim 29, wherein the tube includes a fixed position flange to prevent movement of the tube in a given direction relative to the anatomical wall.

31. A medical device comprising a fixation system according to any one of claims 1 to 30.

32. A medical device according to claim 31, wherein the medical device is a catheter.

33. A medical device according to claim 32, wherein the catheter is a peritoneal catheter.

34. A medical device according to claim 32 or 33, wherein the catheter comprises an elongate tube comprising a proximal end and a distal end, wherein the distal end is the end of the tube that is closest to the patient.

35. A medical device according to claim 34, wherein the elongate tube comprises a tip having an open end.

36. A medical device according to claim 35, wherein the tube comprises a tip fixation means.

37. A medical device according to claim 34, wherein the tube comprises an integrated tungsten tip.

38. A medical device according to any one of claims 32 to 37, wherein the catheter comprises an elongate cylindrical wall, the wall defining a central lumen there being a plurality of ports allowing fluid communication between the central lumen and the exterior of the catheter.

39. A medical device according to claim 38, wherein the catheter wall defines a secondary longitudinally extending lumen, the wall defining a further plurality of ports allowing fluid communication between the secondary lumen and the exterior of the catheter.

40. A medical device according to claim 39, wherein the plurality of ports comprises at least one aspiration hole and at least one irrigation hole.

41. A medical device according to any one of claims 38 to 40, wherein the wall further comprises a corrugated and / or indented section.

42. A medical device according to claim 41, wherein the corrugated and / or indented section comprises a plurality of holes.

43. A medical device according to claim 41 or 42, wherein the corrugated and / or indented section comprises one or more aspiration holes.

44. A medical device according to any one of claims 31 to 43 wherein the balloon is adhered or welded to an outer wall of the elongate tube.

45. A medical device according to any one of claims 38 to 44, wherein the device comprises a connector at the proximal end of the elongate tube.

46. A medical device according to claim 45, wherein the connector is integral with the elongate tube.

47. A medical device according to claim 45 or 46, wherein the connector comprises means for attachment to an air supply.

48. A medical device according to claim 45, 46 or 47, wherein the connector is sealed with a plug.

49. A medical device according to any one of claims 45 to 48, wherein the connector comprises a central conduit in communication with the elongate tube.

50. A medical device according to any one of claims 45 to 49, wherein the connector comprises two arm portions that extend from the conduit at an angle that is substantially perpendicular to the axis of the conduit.

51. A medical device according to any one of claims 45 to 50, wherein the connector comprises irrigation means, aspiration means and air inlet means, wherein the air inlet means allows for the passage of air into the system and thus to the balloon.

52. A medical device according to any one of claims 31 to 51, wherein the device is coated and / or embedded with an antibacterial, antimicrobial and / or cytostatic coating.

53. A method of treating a patient including the step of fixing a medical device in a body cavity wall, wherein the device includes a fixation system according to any one of claims 1 to 30.

54. A kit comprising a fixation system according to any one of claims 1 to 30 and an air supply.

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