METHOD AND DEVICE FOR MOUNTING A TUBULAR DEVICE IN A FLEXIBLE WALL

Abstract: The invention relates to method and device for inserting a tubular element (21) having a retainer (22, 23) projecting transversely at each end thereof, said retainer being resiliently foldable towards the axis of said tubular element, into a through aperture (25) in a flexible wall (26) accessible from one side (26A) only. A loading tube (11) is passed over the element, the retainers being folded projecting substantially axially from the ends of the element, and the loading tube with the element enclosed therein is passed through the aperture from said one side of the wall. Then, the loading tube is partly withdrawn, the element being held stationary by a tool (10) inserted into the tube from the other end thereof so that the forward retainer (22) as seen in the insertion direction will be released and will unfold at the other side (26B) of the wall. The loading tube is withdrawn further in order that the rear flange will be unfolded at said one side of the wall, said element being left in the aperture with the retainers positioned one at each side of the wall.

Description: METHOD AND DEVICE FOR MOUNTING A TUBULAR DEVICE IN A FLEXIBLE WALL The invention relates to method and device for inserting a tubular element having a retainer projecting transversely at each end thereof, said retainer being resiliently foldable towards the axis of said tubular element, into a through aperture in a flexible wall accessible from one side only. There may be a need of mounting in products of flex ' ible material such as inflatable objects, or hoses of coated fabric or rubber material, tubular elements of different kinds for example bushings, connectors, or valves, in a flexible wall which is accessible from one side only. The purpose of the invention is to facilitate such mounting, and in order to achieve said purpose the method referred to above has obtained, according to the invention, the characterizing features of claim 1. The method of the invention can also be applied for inserting a voice prosthesis i. e. a low-resistance indwelling device for prosthetic voice rehabilitation after total laryngectomy, which is inserted in a tracheoesophageal fistula. A voice prosthesis of this type is disclosed in US-A-5, 314, 70. The device of the invention is of the type comprising a loading tube for receiving the tubular element therein with the retainers thereof folded and projecting axially from the element, and a tool to be received in the loading tube to be engaged with the tubular element therein, said loading tube and said tool being relatively displaceable for pushing the element out of the loading tube. According to the invention the device has obtained the characterizing of claim 9. The device is preferably used for practising the method of the invention. SUBSTTTUTESHEET(RULE26) An example of the method according to the invention and a device for practising said method will be described in more detail below reference being made to the accompanying drawing in which FIG. 1 discloses, as also the following figures do, the tool in side view, and a tubular element comprising a bushing passed onto the end of the tool, as well as the loading tube in axial cross sectional view, • - FIG. 2 discloses the step of the method according to the invention wherein the loading tube is being passed onto the tool, FIGS. 3 to 6 disclose the loading tube in different displaced positions on the tool, FIG. 7 discloses the tool with the bushing positioned, the loading tube being removed, FIG. 8 discloses the bushing separated from the tool, FIG. 9 discloses the bushing in the mounted position thereof in the flexible wall after an anchoring security string having been cut off, and FIG. 10 is a fragmentary axial cross sectional view of the loading tube and discloses a modified embodiment of the insertion end of the loading tube. The device for practising the method is a tool comprising an inserter 10 constructed as an elongate shank, and a loading tube 11 both of rigid plastics or other suitable material. The inserter has at one end thereof a handle 12 and at the other end a cylindrical head 13 including a conically bevelled end portion 14. Between the handle and the head the inserter forms adjacent the handle a flat portion 15 having rectangular cross section, and adjacent the head a portion 16 having circular cross section. In portion 15 there is provided adjacent portion 16 a key hole forming a wider circular portion 17 and a narrower slot-shaped portion 18. In portion 15 there are SUBSTITUTESHEET(RULE28) provided adjacent handle 12 three markings or indices 19A, 19B and 19C. Loading tube 11 can have a cylindrical lumen but preferably the lumen thereof tapers conically from a larger inside diameter at one end of the loading tube, the right end in the drawing, to a smaller inside diameter at the other end of the loading tube, the left end in the drawing. The loading tube at the wider right end has a slot 20 extending axially from the end edge of the loading tube. '-- The bushing 21 to be mounted by the method according to the invention and by using the insertion tool described is cylindrically tubular and forms a central passage. It has at each end a flange 22 and 23, respectively, integral with the rest of the bushing. An anchoring security string 24 is formed as a tail integral with one flange 23. The flanges including string 24, or the bushing in its entirety can consist of an elastic material, e. g. rubber or rubber¬ like plastics. Inside the bushing there may be provided a mechanism of some kind, e. g. a one-way valve, or the bushing may be constructed as a connection for connecting a hose or another conduit for gas or liquid. At the left end as seen in the drawing the passage of the element has a restriction such as an internal annular bulge 21A. It should be mentioned here that the bushing may be constructed in other ways. E.g. it is not necessary that the flanges are elastic. They can be more or less rigid and be provided with bending scores allowing the flanges to be folded, or they may comprise a number of foldable flaps which may overlap at adjacent edges when being folded In the first step of the method according to the invention bushing 21 is passed onto head 13 which must of course have such dimensions that it can be introduced into the central passage of the bushing until it engages the restriction in the passage. It may be retained more or less firmly on the head by friction, such frictional engagement being relied upon in order to prevent the bushing from falling off the inserter. In that case security string 24 can be dispensed with. However, improved security is obtained by inserting string 24 at the end portion thereof into the wider portion 17 of the key hole and then pulling it firmly in the direction towards head 13 into the narrower portion 18 of the key hole the string being clamped in said latter portion. The bushing is now anchored to the inserter in the manner disclosed in FIG. 1. The bushing may be attached to the inserter in the reversed order, i. e. string 24 is first clamped in the narrower portion 18 of the key hole and then under resilient streching of the security string the bushing iε passed onto head 13, which is facilitated by the bevelled end portion 14. The security string preferably is left under tension in a streched condition when the bushing is positioned on head 13 received in the passage of the bushing. Instead of the security string being anchored to the inserter it can be made sufficiently long in order to be held by the operator who is manipulating the inserter. It is also possible to provide the bushing with a rigid ring or socket fixedly attached to the bushing in the passage thereof, and in that case the ring or bushing and the inserter can have interengaging formations cooperating as a bayonet joint the anchoring security ring being dispensed with. As a further modification of the method of the invention the bushing can be introduced into the loading tube without first being mounted on the inserter. When the bushing has been introduced into the loading tube the inserter can be engaged with the bushing by abutting the adjacent end thereof or by being inserted into the central passage of the bushing. In the next step loading tube 11 is passed at the wider end thereof onto bushing 21, slot 20 being directed upwards, flange 22 being squeezed between the thumb and the index finger and partly folded in a forward direction (to the left as seen in the drawing) . Flange 22 will protrude partly from the loading tube through slot 20 at the top as shown in FIG. 2. The protruding part of flange 22 being pressed down by the thumb, loading tube 11 is displaced over the inserter to sqeeze alεo the protruding part of flange 22 into the loading tube and to achieve a complete forward folding of said flange. By further displacement of the '-loading tube in relation to the inserter flange 23 will be folded backwards . The loading tube is pushed so far over the inserter that flange 22 will be close to the narrower left end of the loading tube as shown in FIG. 3, and this position is indicated at the right end of the loading tube, which is located at index 19A. The loading tube may be pre- lubricated internally to facilitate passage of the bushing through the tube . In order to introduce the bushing into an aperture 25 in a flexible wall 26 which is accessible from one side 26A but not from the other side 26B, the inserter with the loading tube and the bushing is now pushed as a unit through aperture 25 from wall side 26A towards the left as illustrated in FIG. 3, head 13 engaging the inside bulge 22A in the central passage of the bushing. In the following step inserter 10 and bushing 21 are pushed forwards in loading tube 11 which is held stationary by the operator, or the loading tube is withdrawn while the inserter and the bushing are held stationary so that flange 22 will be located outside the left end of the loading tube. This position of the loading tube in relation to the inserter is indicated at the right end of the loading tube at index 19B and allows flange 22 to be unfolded. When this has taken place the inserter with the loading tube and the bushing is withdrawn as a unit towards the right as seen in the drawing until flange 22 engages wall side 26B, FIG. 5, the pull applied to the inserter possibly being so great that wall 26 will be partly compressed as indicated in the drawing. Due to anchoring by means of the anchoring security string 24 and also to some extent due to friction between the bushing and the head, if any, the bushing is prevented from sliding off the inserter. With the flange thus engaged the loading tube is further withdrawn to a position which is indicated at index 19C, FIG. 6, at the right end of the loading tube in order to release also flange 23 so that it can unfold on wall side 26A the loading tube then being withdrawn completely from the inserter, FIG. 7. String 24 is disconnected from inserter 10 which is withdrawn from bushing 21 which then will be left in wall 26 with the flanges projecting around the aperture at opposite sides of the wall, FIG. 8. Due to the wall being compressed between the flanges a tight and stable attachement of the bushing in the wall will be secured. String 24 is cut off, and mounting of the bushing in the aperture is completed, FIG. 9. The inserter must of course be adapted to the bushing to be mounted in the flexible wall, which can have varying appearance and dimensions depending on the purpose for which it is intended but shall always include of a tubular element with flanges at the ends. It is not necessary that the element terminates at the flanges; it can also project beyond one or the other of the flanges. The flanges should be resilient in order to be folded and then, when they are released, to return to their normal shape, and in case also the tubular element is of an elastic material the element and the flanges can be made integral. Possibly, the element in that case may be provided with a stiffening insert in the central passage thereof. In order to facilitate the insertion of loading tube 11 through aperture 25 in wall 26 even if the loading tube should be directed not perpendicularly but to some extent obliquely to wall surface 26A the loading tube preferably is shaped in the manner disclosed in FIG. 10 at the insert end thereof, i.e. the narrower left end in the drawing. As can be seen in FIG. 10 the tube end is slotted to form a number of inwardly curved flaps 27. In this case the material of the tube should be sufficiently flexible so that the flaps are sufficiently yieldable in order to allow bushing 21 to be pushed out from the loading tube end. By the curved shape of the flaps the loading tube has no sharp edge which may engage the edge of aperture 25 at the insertion. On the contrary the loading tube end will be gently guided into the aperture by means of the cupola- shaped end formed by the curved flaps. In a modified embodiment the end portion of loading tube 11 consists of an elastic material and tapers towards the opening on the outside of said end portion in order to facilitate the insertion of the loading tube into aperture 25. After such insertion the bushing can be pushed out of the loading tube said end portion thereof being expanded under resilient yielding when the bushing is passing through said end portion. If element 21 is constructed as a voice prosthesis which is to be mounted in a fistula in the tracheoesophageal wall, said wall and fistula correspond to wall 26 and aperture 25 in the illustrative example.

Claims: CLAIMS 1. Method for inserting a tubular element forming a central passage and having a retainer (22, 23) projecting transversely at each end thereof, said retainer being resiliently foldable towards the axis of said tubular element, into a through aperture (25) in a flexible wall (26) accessible from one side (26A) only, characterized in that a loading tube (11) is passed over the .element the retainers being folded to project substantially axially from the ends of the element, that the loading tube with the element enclosed therein is inserted at one end of the tube through the aperture from said one side (26A) of the wall, that the loading tube is partially withdrawn the element being held stationary by a tool (10) inserted into the tube from the other end thereof so that the forward retainer (22) as seen in the insertion direction will be released and will unfold at the other side (26B) of the wall, that the loading tube is further withdrawn while the element is being held stationary in order that the rear retainer (23) as seen in the insertion direction will be unfolded at said one side (26A) of the wall, and that the loading tube and the tool are withdrawn from the element which is left in the aperture (25) with the retainers (22, 23) located one at each side (26B and 26A, respectively) of the wall. 2. The method as in claim 1, characterized in that the element (21) is detachably mounted to said tool (10) at one end thereof before the loading tube (11) being passed over the element . 3. The method as in claim 1 or 2, characterized in that the element (21) during insertion thereof is held at a security string (24) projecting from said tubular element. 4. The method as in claim 3, characterized in that said security string is anchored to said tool. 5. The method as in claim 4, characterized in that said security string is passed into the wider portion of a key hole (17, 18) in the tool and under clamping being passed into the narrower portion (18) of the key hole. 6. The method as in any of claims 1 to 5, characterized in that the retainers (22, 23) are folded in a successively increasing degree by the loading tube (11) whiσh is advanced over the element (21) . 7. The method as in any of claims 1 to 6, characterized in that the forward retainer (22) initially when the loading tube (11) being passed over the element (21) is received in a slot (20) at one end of the loading tube and is pressed into the loading tube through the slot before the loading tube is advanced over the element. 8. The method as in any of claims 1 to 7, characterized in that the unfolded forward retainer by withdrawal of the element is engaged with said other side (26B) of the wall. 9. A device for inserting a tubular element (21) forming a central passage and having a retainer (22, 23) projecting transversely at each end thereof, said retainer being resiliently foldable towards the axis of said tubular element, into an aperture (25) in a wall accessible from one side only, comprising a loading tube (11) for receiving the tubular element therein with said retainers folded and projecting axially from the element, and atool (10) to be received in the loading tube to be engaged with the element therein, said loading tube and said tool being relatively displaceable for pushing the element out of the loading tube, characterized in that an end portion of said loading tube (11) is tapering at the outside surface thereof. 10. The device as in claim 9, characterized in that said end portion is resiliently expandible by pressure against the inside surface thereof. 11. A device as in claim 9 or 10, characterized in that said end portion of the loading tube is slotted to form flexible flaps (27) curved towards the center of the loading tube . 12. A device as in any of claims 9 to 11, characterized in that the tool (10) formε a key hole having a wider portion (17) and a narrower portion (18) , for anchoring a security string (24) to the tool by clamping the security string in said narrower portion. 13. A device as in any of claims 9 to 12, characerized in that the lumen of the loading tube (11) tapers from a larger inside width at one end of the tube to a smaller inside width at the other end of the tube. 14. The device of claim any of claims 9 - 13, characterized in that the loading tube forms an axial slot extending from the end edge of the tube at the wider end thereof.

Inventors: SIEGBAHN NILS, SIEGBAHN, NILS
Applicants: SIEGBAHN NILS, UTVECKLINGS AB HECTOR, SIEGBAHN, NILS
Application year: 1996
Main classification: B29C65
IPC codes: A61F2, B25B27, B29C65, F16B17