Seton for treating fistulae, and a method of forming a closed loop of a seton

Abstract

A size-adjustable seton (1) for treating fistulae (32) is provided with first and second wire ends (4, 6), which are provided with connecting means (8, 10) for, in a connected state, forming a smooth connection (12); in such a way, the seton (1) is a smooth, closed loop (3). The invention also relates to a method of forming the closed loop using the aforesaid seton (1), and a melt clamp (40) for use when placing the seton (1) in a person (30).

Claims

1. A seton for treating a fistula, comprising: a wire having an elongate and flexible tubular structure on the order of ten times longer than it is wide, a first wire end, a second wire end and an inner surface extending in a longitudinal direction from a first wire end inner surface to a second wire end inner surface; and a connection body including a first insertion portion having a first outer surface in the longitudinal direction of the wire at least partially conformed to the first wire end inner surface enabling a smooth connection in the longitudinal direction of the wire such that the seton becomes a smooth, closed loop.

2. The seton as set forth in claim 1, wherein the connection body, the wire or both include a thermoplastic material for providing the smooth connection.

3. The seton as set forth in claim 1, wherein the connection body, the wire or both include a light-curable material for providing the smooth connection.

4. The seton as set forth in claim 1, wherein the connection body, the wire or both include a chemically-curable material for providing the smooth connection.

5. The seton as set forth in claim 1, wherein the wire is formable in shape.

6. The seton as set forth in claim 1, wherein the wire has a circular cross-section, with a wire diameter optionally in a range of 0.5 mm to 5 mm, and more optionally in a range of 1.5 mm to 2.5 mm.

7. The seton as set forth in claim 1, wherein cutting of the wire to adjust wire length does not affect the smooth connection or the seton becoming the smooth, closed loop.

8. The seton as set forth in claim 1, wherein the connection body is further provided with a second insertion part having a second outer surface in the longitudinal direction of the wire which is at least partially conformed to the second wire end inner surface recess to support the smooth connection in the longitudinal direction of the wire.

9. The seton as set forth in claim 8, wherein the connection body between the first insertion part and the second insertion part comprises a transverse thickening.

10. The seton as set forth in claim 8, wherein the connection body has a different color relative to one or more colors of the wire and the wire ends.

11. The seton as set forth in claim 1, wherein the connection body provides an intermediate pin structure or plug structure, such that the first and second wire ends can connect with each other.

12. The seton as set forth in claim 1, wherein the connection body is substantially shorter than the wire.

13. The seton as set forth in claim 12, wherein the connection body has a length no more than half that of the wire.

14. The seton as set forth in claim 1, wherein the wire and the connection portion provide a smooth connection in the longitudinal direction of the wire such that the seton becomes the smooth, closed loop with a substantially constant cross-section at the connection.

Description

BRIEF DESCRIPTION OF THE FIGURES

(1) Next, exemplary embodiments of the invention, only in way of example, will be described with reference to the accompanying diagrammatic drawings, in which corresponding parts designated by corresponding reference symbols are shown; in respect of the accompanying diagrammatic drawings:

(2) FIG. 1 is an illustration of an embodiment of a seton formed into a smooth closed loop according to the first aspect of the invention;

(3) FIG. 2a, FIG. 2b and FIG. 2c are illustrations of an embodiment of a seton in an open state;

(4) FIG. 3 is an illustration of an embodiment of a melt clamp according to the third aspect of the invention; and

(5) FIG. 3a is an illustration of a part of the embodiment of a fuse terminal from FIG. 3.

(6) The drawings are only intended for illustrative purposes, and should not limit the scope of protection which is defined by the claims.

DESCRIPTION OF EMBODIMENTS

(7) Referring to FIG. 1, there is shown an embodiment of a seton 1 for treating a fistula 32 according to a first aspect of the invention. The seton 1 is disposed in a fistula channel 34 of a patient 30 and comprises a wire having a first wire end 4 and a threaded second end 6 which are formed together to provide a smooth connection 8, so that the seton 1, when applied, forms a smooth closed loop 3. The smooth connection 8, and the smooth closed loop 3 are provided by embodiments of the seton 1 which can be realized, of which some will be further explained below.

(8) In FIG. 2a, there is shown an illustration of an embodiment of a seton 1 in a non-closed state. The seton 1 comprises a seton wire 2 which is manufactured from a flexible tube 10 with an inner surface 12 to a first wire end 4 which merges into a first recess 14 with a first inner surface 16 in the local longitudinal direction S of the wire 2. At a second wire end 6, the inner surface 12 merges into a second recess 22, with a second inner surface 24 in the local longitudinal direction S of the wire 2. The illustrated tubular wire 2 has a circular cross-section A, with an outer diameter 1 for example, which has a value of about 1.67 mm, namely substantially 5 french. The tube 10 is optionally easily shortened to a desired length before the wire ends 4, 6 are mutually connected. A connecting arrangement, namely connecting means, of the seton 1 is partially formed by the first and second recesses 14, 22, and partly by a thermoplastic connection body 13 in the form of a plug connection having a transverse thickening 21. This connection plug 13 is optionally implemented by inserting a first insertion portion 18 and a second insertion portion 26 into the first recess 14, and into the second recess 22 respectively. Outer surfaces 20, 28 of such engaging pieces 18, 26 are shaped in a complementary manner to the first and second recesses 14, 22, so that these can be inserted tightly into each other. The thermoplastic material of the connection plug 13 is, for example, made from a thermoplastic material, such as polyurethane or polycarbonate. The tube 10 is also manufactured here from such a thermoplastic material. The thermoplastic connection plug 13 can be in a different color relative to that of the tube 10, and also to that of the wire ends 4, 6. By supplying thermal energy to the plug 13, which is inserted into the recesses 14, 22, the wire ends 4, 6 of the seton 1 and the plug 13 form a ridged connection 8 which is melted together, namely thermally fused.

(9) In FIG. 2b, there is shown another embodiment of the seton 1, which is substantially identical to the embodiment shown in FIG. 2a, but in which the connecting body 13 is formed differently. The connecting body 13 is formed here as a connecting pin 13 manufactured from a thermoplastic material, for example as elucidated in the foregoing. The connecting pin 13 has a first insertion portion 18 and a second insertion portion 26 with first and second outer surfaces 20, 28 that overlap, without an intermediate transverse thickening 21. The wire ends 4, 6 may therefore be in direct contact during mutual connection by means of the connecting pin 13.

(10) According to another embodiment shown in FIG. 2c, the wire 2 and the wire ends 4, 6, are solid and cylindrical, and the connecting means comprise a sleeve 29 of thermoplastic material. The sleeve 29 is provided with a sleeve inside that closes outside edges of both wire ends 4, 6 when placed in position. As a result, the sleeve 29, through supplying thermal energy, can be plastically deformed together with the wire ends 4, 6 to form the smooth connection 8.

(11) In a further embodiment (not shown), the wire 2 is formed as a solid cylindrical structure with a cylindrical second wire end that forms the first plug-in part, and with the first wire end having a thickened thermoplastic compound structure that contains a cylindrically shaped first recess along the longitudinal direction of the wire, wherein the cylinder-shaped first insertion part can be received. By melting the thickened connection structure around the second wire end, the smooth connection is thereby formed. The length of the cylindrical wire that is desired to be advanced to the second wire end can be shortened, for example by a cutting operation.

(12) The seton 1 described in the foregoing, together with alternative embodiments of the seton 1 according to the first aspect, can be manufactured into a smooth, closed loop 3 in the longitudinal direction S of the wire 2, by forming of the wire ends 4, 6 and connecting means 13-28 to form a smooth connection 8. Such a seton 1 with the smooth connection 8 can be, for example, achieved by means of a melt clamp 40 according to a third aspect, one of which embodiment is described below in detail.

(13) In FIG. 3 and FIG. 3A, there are shown illustrations of an embodiment of a melt clamp 40. According to this third aspect of the invention, a portable melt clamp 40 is provided with arms 43, 45 which are pivotally connected to form a clip, so that the melt clamp can be manually brought to a closed state. The arms 43, 45 of the portable melt clamp 40 provide a pair of compressible ends, namely clamping parts 42, 44, which are provided with a receiving region 46 for enclosing the seton connecting means when the clamp parts 42, 44 are in a closed condition. According to a corresponding method, the method includes placing the wire ends 4, 6 of the seton 1 into the first receiving region 46.

(14) The portable melt clamp 40 comprises a melt source 48 in the receiving area 46, adapted for applying thermal energy to the connecting means. By employing such a fusing terminal provided by way of the portable melt clamp 40, it is possible, in a very simple manner, to form the thermoplastic material in the connecting means of the seton 1 to provide a smooth joint 8 in a controlled manner.

(15) The portable melt clamp 40 has a locking mechanism 54 for holding the clamping members 42, 44 in a closed state when supplying thermal energy to the connecting means, when present in the receiving area 46. The portable melt clamp 40 is optionally provided with a spring element 56 to force the arms 43, 45 mutually away from each other, thereby causing the clamping parts 42, 44 to open, for example, when the locking mechanism 54 is turned off. Moreover, the portable melt clamp 40 optionally comprises a cooling element 49 in the receiving area 46, for extracting thermal energy from the connecting parts when in a smooth mutually connected state.

(16) The portable melt clamp 40 has a control unit 50 for controlling the melt source 48, the cooling element 49, and the locking mechanism 54. By using the cooling element 49, the thermal energy associated with a previous step fed to the thermoplastic connecting means can be removed, after formation of the smooth wire connection. Such an approach enables the thermoplastic material to solidify faster, so that the smooth connection can be achieved very quickly.

(17) In FIG. 3a, there is shown the first and second clamping members 42, 44 of the melt clamp 40. As shown, a separate thermoplastic connection body 13, here a connect plug with transverse thickening as in FIG. 2a, may be placed in the receiving area 46. According to an embodiment of the method, the method includes placing the thermoplastic connection body 13 in advance in the receiving area 46 of the portable melt clamp 40. The method further includes then passing the wire 2 of the seton 1 through a desired channel, for example by pulling through the fistula channel 34, and eventually shortening the wire 2 to a desired length. Thereafter, the method includes placing the wire ends 4, 6 with the recesses 14, 22 into the melt clamp 40 over and around the insertion portions 18, 26 of the thermoplastic connection body 13. In this embodiment, the connection body 13 does not need to be held during positioning of the seton 1 in a fistula tract 34, so that the hands of a person applying the seton 1 remain free for accurate positioning of the wire ends 4, 6 in the melt clamp 40. Subsequently, the method includes closing the melt clamp 40, and thereafter activating the melt source 48. After the wire ends 4, 6 and connecting body 13 are connected with each other in a smooth connection 8, the method includes cooling the whole setup by means of the cooling element 49. During the whole process, the locking mechanism 54 keeps the clamping members 42, 44 closed. The optical indicator 52 may be functionally lit with multiple colored LEDs to indicate various stages of the operation of the melt clamp. Audible sounds may also be used as indicators.

(18) It will be appreciated that the above described embodiments, are described only by way of example and not limiting in any sense, and that various changes and modifications are possible without departing from the scope of the invention and that the scope is determined only by the appended claims.

(19) TABLE-US-00001 LIST OF REFERENCE SIGNS 1: seton 20: first outer surface 43: first arm 2: wire 21: transverse thickening 44: the second clamping part 3: smooth closed loop 22: the second recess 45: second arm 4: first wire end 24: the second inner 46: receiving area surface 6: second wire end 26: the second insertion 48: melt source portion 8: smooth connection 28: second outer surface 49: cooling element 10: tube 29: sleeve 50: control unit 12: inner surface 30: patient 52: optical indicator 13: thermo-plastic 32: fistula 54: locking mechanism connection body 14: the first recess 34: fistula tract 56: spring 16: first inner surface 40: melt clamp 18: first insertion 42: first clamping means portion A: cross section S: longitudinally 1: first diameter

REFERENCES

(20) 10 [1] DROP, J G. Integrated Circuit Personalization at the Module Level, IBM tech. dis. bull. October 1974, Vol. 17, No. 5, p. 1344-1345, ISSN 2345-6789.