External terminal device and method for connecting the same to a flow line

Abstract

An external terminal device has a housing (4), a mounting member (15) housed in the housing (4) and having at least one distal portion (16) of a conduit (3) and two proximal conduits (17, 17) into which a pair of elbows (18, 18) are inserted with their distal ends (180). The elbows (18, 18) have proximal ends (181) into which a pair of nozzles (190, 190) are inserted. Inside each nozzle (190) there is a cap (20) adapted to hermetically seal the nozzle (190). A penetration and connection conduit (24) is adapted to reversibly penetrate the cap (20) and connect the pair of nozzles (190, 190) to a flow line of a treatment device. A method of connecting the external terminal device to a flow line of a machine is also disclosed.

Description

Technical Field

[0001] The present invention relates to an external terminal device which can be used, for example, in hemodialysis, peritoneal dialysis and chemotherapy. The present invention also describes a method of connecting the external terminal device to a flow line of a treatment device. Background Art

[0002] US6,969,381 B2 discloses a two-part detachable hemodialysis device: a distal part of the flow line of the hemodialysis machine, which is connected to a two-lumen catheter implanted in the patient and fixed thereto with sutures; a proximal part, which can be attached to the two-lumen catheter and has a respective extension tube, the end of which has a proximal Luer connector for connecting to the flow line. A flow blocking clip is provided on each extension tube.

[0003] When the proximal part of the device is separated from the distal part, the latter (distal part) remains open and is therefore susceptible to dirt and infection. If the proximal and distal parts remain together, the patient is forced to wear both even if the device is disconnected from the hemodialysis machine. Also, in this case, the Luer connector is exposed to the outside and is susceptible to dirt.

[0004] WO / 2010 / 146614 discloses an external terminal device for a permanent catheter, comprising a container, which can be connected to at least one catheter on one side and to a closure cap on the other side, the closure cap containing a disposable absorbent material impregnated with an antimicrobial substance. The container contains two taps equipped with a knob, which can be operated from the outside. The two taps are equipped with a first terminal for connecting to the catheter on the one hand, and a second terminal protruding from the container for connecting to an external device on the other hand. The first terminal is connected to the catheter, which comes out of the container through at least one non-rigid support sleeve, which is in turn integral with the container. The support sleeve carries a sleeve on the outside, which is intended to be positioned in the subcutaneous tissue of the patient's body. The second terminal is provided with a cap surrounded by a disposable absorbent material located in the closure cap. The closure cap makes the absorbent adhere to the cap and covers them to protect them from external bacterial attacks, and also uses the antimicrobial substance with which it is impregnated. The knob located outside the container operates the tap connected to the catheter. Each tap moves a ball that sits inside a corresponding tube connected to the catheter, turning the flow of blood on and off as necessary.

[0005] The sphere is a foreign material that is passed through by the blood, which is subjected to pressure due to friction as the sphere passes through and by the interruption of the flow of blood.

[0006] To overcome this, WO / 2013 / 108280 discloses an external terminal device for a permanent catheter, in which two sleeve valves and two elastic tubes used as valve sleeves replace the tap of the device disclosed in WO / 2010 / 146614. The device according to WO / 2013 / 108280 avoids mechanical actuation of the blood by the tap, but does not exclude stress on the blood caused by the squeezing of the vertical element, which acts on the two elastic tubes and interrupts the blood flow when the patient is disconnected from the hemodialysis treatment device or the like.

[0007] US 9,295,773 B2 describes an access system for hemodialysis treatments, the applicant of which is the founder of Biolink, who contributed to the development of a product called Dialock. The system described in the above patent includes an interface fluid conduit between the machine and the patient's blood supply. This can be repeatedly connected along a guide path through the epidermis and subcutaneous tissue. The device described in US 9,295,773 B2, although having considerable advantages, requires the installation of a subcutaneous port and also requires repeated puncture of the patient's skin at each hemodialysis treatment. Summary of the invention

[0008] The present invention is intended to overcome the above-mentioned disadvantages and difficulties.

[0009] One object of the present invention is to provide an external terminal device for one or two permanent conduits which improves their isolation from the environment, therefore from pathogenic microorganisms, as well as the isolation of their opening and closing devices.

[0010] Another object of the present invention is to eliminate frictional stress or "shear stress" induced in the blood.

[0011] Another object of the present invention is to provide a terminal device which has no taps or valves and which therefore does not require verification of their actual closed position.

[0012] Another object of the invention is to provide a terminal device allowing the detection of the analyte concentration in the blood of a patient.

[0013] In a first aspect of the present invention, there is provided an external terminal device as described in claim 1 and its dependent claims.

[0014] In a second aspect of the present invention, a method of connecting an external terminal device to a flow line of a therapeutic apparatus as described in claim 11 is provided. BRIEF DESCRIPTION OF THE DRAWINGS

[0015] Further features and advantages will become most apparent in the present description of embodiments of the external terminal device shown by way of non-limiting example with the aid of the accompanying drawings, in which:

[0016] Figure 1 shows a general perspective view of a first embodiment of a device according to the invention in a closed position;

[0017] Figure 2 Shows Figure 1 An exploded perspective view of an external terminal device in the embodiment of the present invention, including penetration and connection conduits connected to a flow line of a treatment device for hemodialysis;

[0018] Figure 3 Shows Figure 2 Exploded perspective views of parts of the pipes, especially those of the penetrations and connections;

[0019] Figure 4 is a top view of a second embodiment of an external terminal device according to the present invention;

[0020] Figure 5 yes Figure 4 A top view of a second embodiment of an external terminal device in FIG. 1 without a removable cover and lid to illustrate the interior of the device;

[0021] Figure 6 Shows Figure 5 A longitudinal cross-sectional view of the device in FIG. 1 with portions removed for clarity;

[0022] Figure 7 Shown with Figure 6 the corresponding stereogram; and

[0023] Figure 8 and Fig. 9 The exploded view and the assembled state are shown along the Figure 3 Exploded longitudinal cross-sectional view of the flow lines penetrating and connecting pipes in FIG. DETAILED DESCRIPTION

[0024] refer to Figure 1 , which is an overall perspective view of a first embodiment of an external terminal device according to the present invention, which is in a closed position, i.e., not connected to the flow line of a blood treatment apparatus. The external terminal device, generally indicated as 1, is incorporated into a two-lumen catheter 3 implanted in a patient in the following catheter 3. The catheter 3 passes through a tubular sheath 2 suitable for anchoring the terminal device outside the patient's body. The external terminal device 1 comprises a housing 4, which comprises a base 5 and a removable cover 6, which is fixed to the base 5 by screws (generally indicated as 7). Two rings 8 ( Figure 1 The cannula 9 is applied to the tubular sheath 2 and is intended to be placed in a subcutaneous position. The housing 4 is closed with a cover 10. Figure 2More clearly visible in Figure 2 Shows Figure 1 Exploded perspective view of an external terminal device 1 in FIG. 1 having penetrations and connection conduits connected to a flow line (not shown) of an apparatus for hemodialysis treatment.

[0025] The base 5 comprises a side wall 50 to which a removable cover 6 is fixed by screws 7 with a gasket 11 inserted therein. In the side wall 50, the base 5 has a distal opening 12 and a pair of proximal openings 13, 13 relative to a flow line of a treatment device for hemodialysis.

[0026] The distal opening 12 and the proximal openings 13, 13 are delimited on three sides by grooves designed to form guides for inserting the septum. In particular, the distal opening 12 provides for the insertion of a perforated septum 14, which is equipped with a wall 140 and a tube column 141 passing through the wall 140. The catheter 3 passes through the tube column 141 to engage the mounting 15 located in the base 5. The distal part 16 of the mounting 15 is generally a two-lumen catheter tube that engages the catheter 3. The two proximal tubes 17, 17 of the mounting 15 are assembled into the distal end 180 of the elbows 18, 18. In the proximal end 181 of the elbows 18, 18 are inserted nozzles 190, 190, which are connected to the corresponding nozzle cavities 191, 191, as shown in FIG. Figure 3 As shown, the Figure 3 yes Figure 2 1, a partially exploded perspective view of the nozzle 190, 190 on an enlarged scale, in particular of the penetration and connection ducts. The nozzle cavities 191, 191 are received in through-septa 19, 19 intended to be retained in the proximal openings 13, 13 of the wall 50 of the housing 4. The nozzle cavities 191, 191 have a generally cylindrical shape, tapering towards the nozzles 190, 190. As shown in FIG. Figure 2 and 3 As shown, the cap 20 is inserted into each nozzle cavity 191.

[0027] The cap 20 is reversibly permeable, having a generally cylindrical shape, tapering distally, similar to the nozzle cavity 191. The reversibly permeable feature means that the cap 20 can be perforated by a penetrating member and restores a perfect seal after the penetrating member is withdrawn. The reversibly permeable cap 20 can be made of silicone or other suitable materials.

[0028] In this way, when the external terminal device 1 is not in use, the silicone cap 20 perfectly closes the passage of the nozzle 190, and the housing 4 is closed by the cover 10, in which the antibacterial sponge 21 is inserted. The cover 10 has distal protrusions 22, 22, the ends of which engage corresponding recesses indicated as 23 in the removable cover 6 and similar recesses (not shown) formed on the outside of the bottom wall of the base 5 of the housing 4.

[0029] Reference now Figure 4 and 5 , which are top views of a second embodiment of the external terminal device, Figure 5 The device is shown without the removable cover and lid. Figure 6 and Figure 7 , which respectively show Figure 5 Longitudinal cross-sectional and perspective views of the device in FIG. 1 , with parts removed for clarity.

[0030] According to a second embodiment of the invention, the external terminal device comprises a biosensor 60 having a sensitive element 62. For this purpose, a transparent window 300 is provided in the catheter 3, which faces the sensitive element 62 of the biosensor 60, so that the sensitive element 62 is in the field of view of the blood lapped over the catheter 3. In addition to the two proximal conduits 17, 17, the mounting 15 comprises an entry conduit 182 leading to the catheter 3, in which the biosensor 60 is partially arranged. The biosensor 60 comprises an optical fiber 61, at the end of which the sensitive element 62 is arranged. The optical fiber 61 is inserted through the entry conduit 182. An optical system 63 is connected to the optical fiber 61. The biosensor 60 is able to detect the analyte sought in the blood due to the optical reaction of the sensitive element of the analyte according to known technology.

[0031] A detection and transmission system 64 of the disclosed content is also provided. The detection and transmission system 64 is a microprocessor that manages the signal processing, its mathematical operations and data storage. The detection and transmission system 64 can be physically connected or wirelessly connected. The optical system 63 includes a variable wavelength light source that allows scanning of various substances dissolved in the blood, which have different degrees of reactivity to the wavelength of the provided light. In order to implement what has been described, reference is made to WO 2006 / 044973, which describes an optical fiber suitable for detecting the concentration of an analyte, in particular the concentration of glucose in the blood of a patient.

[0032] Reference now Figure 3 as well as Figure 8 and Fig. 9 , Figure 8 and 9 The Figure 3 An exploded longitudinal sectional view of only one flow line of the penetration and connection pipeline in the assembled state.

[0033] For the purpose of clarity, Figure 3 The reference numerals in FIG. 1 only indicate a portion of the pipe, while the other portions are the same.

[0034] As described later in the disclosure of this method, when the external terminal device 1 is to be connected to the pipeline of the hemodialysis treatment equipment, the cover 10 and the antibacterial sponge 21 are removed. Then, through the cap 20 of the external terminal device, a channel is formed for blood by penetrating and connecting the pipeline 24. Starting from the far side, the penetration and connection pipeline 24 includes a pair of rigid tubes 25, 25, which are respectively installed in corresponding clamps 26, 26. Each clamp 26 includes a central body 27, which is perforated in the center to form a connection between the rigid tube 25 and the joint 28 located on the opposite side of the central body 27 and the rigid tube 25. Clamping arms 29, 29 are provided above and below the central body 27, and the distal side thereof has a hook 30 for holding the housing 4. The size of the clamping arms 29, 29 is designed to engage the recess 23 formed in the detachable cover 6 and the base 5 on the opposite side of the central body 27. Therefore, a stable connection of the penetration and connection pipeline 24 to the housing 4 is obtained, and therefore a stable connection to the flow line of the treatment equipment is obtained.

[0035] On the opposite side of the clamping arms 29, 29, ie in the proximal duct, there is a clamping rod 31 which is suitably knurled on the outside.

[0036] Inserted on the connector 28 is the distal end 320 of an elastic tube 32 which is coupled at its proximal end 321 to a corresponding locking element, such as a Luer lock indicated as 33, for attachment to a flow line. An occlusion clamp 34 is positioned on each elastic tube 32. A penetrating member 35 for each flow line completes the penetration and connection of the tubing 24. Each penetrating member 35 has a needle 36 and an internally hollow head 37 to close on the locking element 33.

[0037] For simple purposes, Figure 8 A single penetration and connection conduit 24 is shown, wherein the clamp 26 is connected to an elastic tube 32 which, after insertion of the occlusive clamp 34, is in turn connected to a locking element 33. A penetrating member 35 is shown separately.

[0038] like Fig. 9As shown, once fully assembled, the penetration and connection conduit 24 is close to the external terminal device so that the tip of each needle 36 passes through the locking element 33, the elastic tube 32, the joint 28, the central body 27 of the clamp 26 and the rigid tube 25, and penetrates the cap 20 located in the nozzle cavity 191 of the piercing septum 19. When the clamping arms 29, 29 engage the nozzle of the piercing septum 19 with the hook 30, each cap 20 is penetrated and the rigid tube 25 coaxial with the needle 36 is passed inside it. In this way, when the penetrating members 35, 35 are withdrawn and the locking elements 33, 33 are connected to the flow line of the hemodialysis treatment device, a connection is formed between the flow line of the treatment device and the nozzle 190, 190. The occluding clips 34, 34 closed on the elastic tubes 32, 32 before the insertion of the penetrating members 35, 35 can be opened and the treatment can be started.

[0039] At the end of the treatment, the closing clamps 34, 34 are closed and the penetration and connection tubing 24 is pulled out of the external terminal device 1. During the pulling out, the rigid tubes 25, 25 come out of the respective caps 20 which are sealed closed to their outlets. This prevents leakage of blood and the sheath 4 of the external terminal device 1 can be closed with the antimicrobial sponge 21 and the cover 10.

[0040] Briefly, the method of connecting an external terminal device to a flow line of a therapeutic apparatus according to the present invention comprises the following steps:

[0041] - Remove the cover 10 and the antimicrobial sponge 21 from the housing 4 of the external terminal device;

[0042] - assembling the penetration and connection pipe 24 in line by combining a pair of clamps 26, 26, a pair of elastic tubes 32, 32, a pair of occlusive clamps 34, 34 around the respective elastic tubes 32, 32, a pair of locking elements 33, 33 and a pair of penetration members 35, 35;

[0043] - bringing the penetration and connection pipe 24 thus coaxially mounted close to a pair of nozzles 190 , 190 , until a pair of clamps 26 , 26 are coupled to the housing 4 , followed by reversible penetration of the cap 20 inside the cavities 191 , 191 of the nozzles;

[0044] - removing the pair of penetrating members 35, 35 from the penetrating and connecting conduit 24 while closing the pair of occluding clips 34, 34 around the pair of elastic tubes 32, 32; and

[0045] - Connecting a pair of locking elements 33, 33 to the flow lines of the treatment device.

[0046] It will be appreciated that the intended purpose has been achieved. The external terminal device according to the present invention has performance and efficiency similar to that described in US 9,295,773 B2, but has the advantage that the patient's skin does not have to be penetrated at each connection to the treatment device. Performance is ensured by the airtight seal of the sheath 4 and by minimizing the contact of the patient's blood with the outside, thereby reducing the risk of infection.

Claims

1. An external terminal device, one side of which is connected to a subcutaneous cannula, the other side of which is connected to at least one catheter (3), and the other side of which is connected to a cap (10) or to a flow line of a treatment device, the external terminal device comprising: A housing (4) comprising a base (5) defined by a plurality of side walls (50) and a removable cover (6) on the side walls (50), wherein the plurality of side walls (50) have a distal opening (12) and a pair of proximal openings relative to the flow line, a mounting member (15) housed in the housing (4) and having at least one distal portion (16) and two proximal pipes, wherein the at least one distal portion (16) is engaged in the at least one catheter (3), and a pair of elbows, each elbow having a distal end (180) and a proximal end (181), wherein the distal end (180) is inserted into the corresponding two proximal pipes of the mounting member (15), characterized in that the external terminal device further comprises: a pair of nozzles, which are equipped with a pair of nozzle cavities and are inserted into the proximal ends of the pair of elbows, wherein inside each nozzle cavity is a cap (2 0), the cap (20) is suitable for hermetically closing the nozzles and is reversibly pierceable, and a penetration and connection pipe (24) is designed to reversibly penetrate the cap (20) and connect a pair of nozzles to the flow line of the treatment device, the penetration and connection pipe (24) includes: a pair of clamps located in parallel lines and starting from the distal end of the penetration and connection pipe, which are used to hook the penetration and connection pipe to the housing (4), a pair of elastic tubes, a pair of locking elements, which can be connected to the flow line of the treatment device, a pair of occluding clamps, which are positioned around each elastic tube (32), and a pair of penetration members, each penetration member has a needle (36) and a head (37), the head (37) is hollow inside to close on the locking element, the needle (36) passes through the locking element, the elastic tube, and the clamp to exit from the distal end of the rigid tube (25).

2. The device according to claim 1, characterized in that The cover (10) has two distal protrusions, and the base (5) of the housing (4) and the removable cover (6) have recesses (23), and when the device is closed, the two distal protrusions of the cover (10) can engage the recesses (23), inserting an antibacterial sponge (21) between the nozzle cavity closed by the cap (20) and the cover (10).

3. The device according to claim 1, characterized in that The distal opening (12) is formed by a guiding groove for inserting a perforated spacer, and the pair of proximal openings are formed by guiding grooves for inserting a perforated spacer, a perforated spacer (14) for passing at least one catheter (3) and its attachment to a mounting member (15) are received in the distal opening (12), and a pair of spacers accommodating a pair of nozzle cavities are received in the corresponding pair of proximal openings.

4. The device according to claim 1, characterized in that Each clamp has a central body (27) with a central hole in a colinear manner, a rigid tube (25) for connecting to a corresponding nozzle in the spacer, and a joint (28) located in the central body (27) on the opposite side of the rigid tube (25), each elastic tube has a proximal end (321) and a distal end (320) inserted into the joint (28), and each locking element is connected to the proximal end (321) of the elastic tube on one side.

5. The device according to claim 4, characterized in that The base (5) of the housing (4) and the removable cover (6) have a recess (23), and the pair of clamps have a pair of clamping arms on the side opposite to the central body (27), and the pair of clamping arms are equipped with a corresponding pair of hooks at the distal side, and the pair of hooks are suitable for engaging the recess (23) for stably connecting the penetration and connection pipe (24) to the housing (4).

6. The device according to claim 1, characterized in that The cap (20) is made of silicone.

7. The device according to claim 1, characterized in that In addition to the two proximal channels, the mounting (15) also includes an entry channel (182) to the catheter (3), and a biosensor (60) is partially inserted into the entry channel (182), the biosensor (60) having a sensitive element (62) that can optically react with blood covering the catheter (3).

8. The device according to claim 7, characterized in that The biosensor (60) comprises a sensitive element (62) fixed to an optical fiber (61) received in the catheter (3) through the entry conduit (182), an optical system (63) connected to the optical fiber (61) and comprising a light source with a variable wavelength, and a detection, storage and transmission system (64).

9. The device according to claim 8, characterized in that The catheter (3) has a transparent window (300) facing the sensitive element (62) of the biosensor (60).

10. The device according to claim 1, characterized in that The removable cover (6) is fastened to the side wall (50) by means of screws (7), with washers (11) inserted therein.

11. A method for connecting an external terminal device to a flow line of a therapeutic apparatus, the external terminal device comprising: A housing (4) comprising a base (5) and a removable cover (6), and a cover (10) into which an antimicrobial sponge (21) is inserted, a pair of nozzles provided with nozzle cavities and connected at the distal end to at least one catheter (3) via a mounting member (15), inside each nozzle cavity is a cap (20) adapted to hermetically close the nozzle, the cap (20) being reversibly pierceable, a penetration and connection conduit (24) adapted to reversibly penetrate the cap (20) and connect the pair of nozzles to a flow line of a treatment device, the penetration and connection conduit (24) comprising: a pair of clamps in parallel lines, starting from the distal end of the penetration and connection conduit, for hooking the penetration and connection conduit to the housing (4), a pair of elastic tubes, a pair of locking elements, which can be connected to the flow line of the treatment device, a pair of occlusion clamps, which are positioned around each elastic tube (32), and a pair of penetration members, each penetration member having a needle member ( 36) and a head (37), the head (37) being hollow inside to be closed on the locking element, the needle (36) passing through the locking element, the elastic tube, and the clamp to withdraw from the distal end of the rigid tube (25), characterized by the following steps: removing the cover (10) and the antibacterial sponge (21) from the shell (4); assembling the penetration and connection pipe (24) in a colinear manner by combining a pair of clamps, a pair of elastic tubes, a pair of occlusion clamps around the corresponding pair of elastic tubes, a pair of locking elements and a pair of penetration members; making the installed penetration and connection pipe (24) coaxially approach a pair of nozzles until a pair of clamps (26) are connected to the shell (4), and then reversibly penetrating the cap (20) in the pair of nozzle cavities; removing the pair of penetration members (35) from the penetration and connection pipe (24) while closing a pair of occlusion clamps around a pair of elastic tubes; and connecting a pair of locking elements to the flow line of the treatment device.

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