EXTERNAL TERMINATION DEVICE WITH TISSUE IN-GROWTH CUFF - Patent application

Abstract

The external termination device has a casing (4) including a base (5), with a distal opening (12) formed in the casing (4) for receiving a funnel-shaped septum (14) having a tubular body (140). Inside the tubular body (140), a catheter (3) is connected to a distal section (16) of a fitting (15). A tubular coating (2) has a proximal end configured to be joined onto the tubular body (140) and a distal end that coaxially attaches to the catheter (3). A pair of bands (90, 91) of tissue ingrowth material are secured onto the tubular coating (2), and an anchor ring (92) comprising anchoring means is sandwiched between the bands (90, 91).

Description

[Technical field]

[0001] The present invention relates to an external termination device that can be used, for example, in hemodialysis, peritoneal dialysis and chemotherapy.The external termination device includes a tissue ingrowth cuff. [Background technology]

[0002] Current cuffs placed on permanent central venous catheters consist of a Dacron band glued to the catheter itself and have both mechanical and biological functions.

[0003] From a mechanical point of view, these cuffs, which are usually ring-shaped pads, are made from materials that are not compatible with the body. When positioned in the subcutaneous tissue, the cuff is integrated into the body even though it creates a reaction that tends to separate the cuff from the surrounding tissue. The result is the formation of scar tissue that penetrates into the fibers of the Dacron itself, effectively blocking it at this location, with the end result being an attachment that holds the cuff in place, preventing it from sliding outwards, thus avoiding accidental expulsion of the catheter itself.

[0004] From a biological point of view, this scar tissue at the same time forms a kind of barrier against the progression of bacterial colonies along the subcutaneous tunnel inside which the catheter is located, which would inevitably reach the part of the catheter that is inserted into the bloodstream and cause first a local and then a global infection.

[0005] However, all this is very limited by the small size of the cuffs, which in the known art are usually not very wide, and which over time, due to the care of nurses to patients using these catheters, cause the formation of scar tissue that loses its mechanical function, resulting in the release of the catheter and its gradual expulsion.

[0006] US Patent No. 5,399,933 discloses a tissue ingrowth cuff for stabilizing an inserted catheter against migration. The cuff is actuated by the surgeon once it has been moved to its desired location to grip the catheter. The cuff comprises two body parts which are separately slidable along the catheter before joining, but which may be attached to each other around the catheter by complementary gripping sections. Tissue ingrowth material is attached to the outwardly facing surface of the cuff within the subcutaneous tunnel after insertion of the catheter, thus anchoring the catheter against migration.

[0007] The cuff described in the '691 patent has the advantage that it can be positioned at a desired location by the surgeon, however, anchoring of the cuff is subject solely to tissue ingrowth around the cuff. [Prior art documents] [Patent documents]

[0008] [Patent Document 1] US Patent Application Publication No. 2012 / 0209206 Summary of the Invention [Problem to be solved by the invention]

[0009] It is an object of the present invention to prevent a catheter connected to an external termination device from being displaced from its position within the subcutaneous tunnel where it was placed by the surgeon. [Means for solving the problem]

[0010] The object is achieved by an external termination device comprising a tissue ingrowth cuff as defined in the appended claims.

[0011] Advantageously, a cuff according to the present invention comprises two separate Dacron bands instead of just one.

[0012] The width of the Dacron band is large compared to that of catheters on the market today, which, as can be easily understood, already greatly increases the mechanical grip of the cuff itself.

[0013] From a biological standpoint, it is clear that this greater width creates an increased barrier to bacterial progression, and thus bacteria must travel a longer path to be able to cross the barrier and reach the portion of the catheter that is placed in the blood.

[0014] Between the two bands there is a rigid polysulfone ring, which at its base has two small projections in the shape of hooks oriented at 45°, which at the moment of insertion are anchored to the underlying muscle band by simple, light pressure applied from the outside to the projections, which strengthens and stabilizes the mechanical grip of the cuff itself.

[0015] Further features and advantages will become more apparent in the present description of preferred but non-exclusive embodiments of an external termination device, given as non-limiting examples with the aid of the attached drawings, in which: [Brief description of the drawings]

[0016] [Figure 1] 1 shows a general perspective view of an embodiment of a device according to the invention in a closed position. [Diagram 2] 2 shows a plan view of the device of FIG. 1. [Diagram 3] FIG. 2 shows a side view of the device of FIG. 1. [Figure 4] 2 shows a plan view of the device of FIG. 1 without the cover element and the closing lid. [Diagram 5] FIG. 2 is an exploded perspective view of the device of FIG. 1. DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENTS

[0017] Reference is made to Figure 1, which is a general axonometric view of an embodiment of an external termination device according to the present invention in a closed position, i.e., not connected to a flow line of a blood processing machine. The external termination device, generally designated 1, is joined to a two-lumen catheter inserted into a patient. As will be explained in detail below, the catheter, designated 3, can pass through a tubular coating 2 configured to anchor the external termination device to the patient.

[0018] 2 to 4, which respectively show a top view, a side view and a distal end view of the external termination device 1 of FIG. 1, the external termination device 1 comprises a casing 4 comprising a base 5 and a removable cover 6 fixed to the base 5 by means of screws generally indicated as 7. Integrated into the base 5 are two rings 8 which serve to sew the external termination device 1 to the skin of a patient. The casing 4 is closed by a lid 10.

[0019] 5, which is an exploded perspective view of the external termination device 1, the casing 4 is shown to be closed by the lid 10 with an intervening germicidal sponge 21. The lid 10 has distal projections 22, 22 whose ends engage corresponding recesses, designated as 23 in the removable cover 6, and similar recesses (not shown) created externally in the bottom wall of the base 5 of the casing 4.

[0020] The base 5 has a side wall 50, and a removable cover 6 is fixed onto the side wall 50 by screws 7 with an intervening gasket 11. The base 5 has a distal opening 12 and a pair of proximal openings 13, 13 for a flow line of treatment equipment (not shown) for hemodialysis.

[0021] The distal opening 12 and the proximal opening 13, 13 are bounded on three sides by grooves configured to form guides for the insertion of a septum. In particular, as shown in FIG. 5, the distal opening 12 provides for the insertion of a septum 14, as will be seen below.

[0022] The fitting 15 housed in the casing 4 has a distal tube 16 that engages with the catheter 3 and two proximal tubes 17, 17. Each tube of the pair of curved tubes 18, 18 has a distal end 180 that is inserted on the respective proximal tube 17 of the fitting 15 and a proximal end 181. A pair of nozzles 190, 190 are inserted into the proximal ends 181, 181 of the curved tubes 18, 18. The distal opening 12 receives a funnel-shaped septum 14 with a tube main part 140, inside which the catheter 3 is connected to the distal tube 16 of the fitting 15. The tubular coating 2 has a proximal end that can be joined onto the tube main part 140 and a distal end that is coaxially attached to the catheter 3. A pair of bands 90,91 of tissue ingrowth material are fixed onto the tubular coating 2 and an anchoring ring 92 comprising anchoring means is sandwiched between the bands 90,91.

[0023] The anchoring means consists of two sharp protrusions 93,93, preferably hook-like, facing outwardly from the ring 92. The sharp protrusions 93,93 are advantageously angled at 45° to each other and face oppositely towards the patient's skin. Preferably, the bands 90,91, which are greater than 1 cm wide, are made from Dacron, whilst the anchoring ring 92 is made from polysulfone.

[0024] The catheter 3, which is hooked to a fitting 15 arranged inside the base 5, passes through the tube main part 140 of the septum 14. The distal tube 16 of the fitting 15 is usually a two-lumen catheter part that is inserted into the catheter 3. The two proximal tubes 17,17 of the fitting 15 are inserted into the distal ends 180 of the curved tubes 18,18. The nozzles 190,190 received through the septum 19,19 intended to be held in the proximal openings 13,13 in the wall 50 of the casing 4 are inserted into the proximal ends 181 of the curved tubes 18,18. [Explanation of symbols]

[0025] 2 tubular coating, 3 catheter, 4 casing, 5 base, 6 cover, 10 lid, 12 distal opening, 13 proximal opening, 14 funnel-shaped septum, 15 fitting, 16 distal tube, 17 proximal tube, 18 curved tube, 50 side wall, 90, 91 band, 92 anchoring ring, 93 protrusion, 140 tube main part, 180 distal end, 181 proximal end, 190 nozzle

Claims

1. An external termination device comprising a tissue ingrowth cuff, said external termination device being configured to be connected on one side to a catheter (3) and on the other side to a flow line of a processing device, said external termination device comprising: a casing (4) comprising a base (5), a number of side walls (50) provided with a distal opening (12) and a pair of proximal openings (13, 13) with respect to said flow lines, and a removable cover (6) on said side walls (50); a fitting (15) housed in said casing (4), said fitting (15) having a distal tube (16) engaging with said catheter (3) and two proximal tubes (17, 17); a pair of curved tubes (18, 18) each having a distal end (180) inserted onto the proximal tube (17) of each of said fittings (15) and a proximal end (181); a pair of nozzles (190, 190) inserted in the proximal end (181, 181) of the curved tube (18, 18); Equipped with the distal opening (12) of the casing (4) receives a funnel septum (14) having a tube main portion (140), the catheter (3) is connected to the distal tube (16) of the fitting (15) inside the tube main portion (140), and a tubular coating (2) has a proximal end adapted to be inserted onto the tube main portion (140) and a distal end coaxially attached to the catheter (3), - a pair of bands (90, 91) of tissue ingrowth material are attached to said tubular coating (2); a device characterised in that an anchoring ring (92) provided with anchoring means is sandwiched between said pair of bands (90, 91).

2. 2. A device according to claim 1, characterized in that the anchoring means consist of two hooked sharp projections (93, 93) facing outwards from the anchor ring (92).

3. 3. A device according to claim 2, characterized in that the sharp projections (93, 93) of the two hooks are angled from each other by 45 degrees.

4. 2. The device of claim 1, wherein said pair of bands (90, 91) are made from Dacron.

5. 2. The device according to claim 1, characterized in that each band of the set of bands (90, 91) has a width greater than 1 cm.

6. The device of claim 1, wherein the anchoring ring (92) is made from polysulfone.

7. A device as described in claim 1, characterized in that when the external termination device is not connected to the flow line of the processing apparatus, the casing (4) is configured to be closed by a lid (10) with a germicidal sponge (21) interposed therebetween.

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