CN213131264U

CN213131264U - Anti-clogging implantable drug delivery device

Info

Publication number: CN213131264U
Application number: CN202021097716.5U
Authority: CN
Inventors: 古湖南; 张海涛; 汪瀚; 樊建锋; 龙小燕
Original assignee: East China Institute Of Digital Medical Engineering
Current assignee: Jiangxi Yuansai Medical Technology Co ltd
Priority date: 2020-06-15
Filing date: 2020-06-15
Publication date: 2021-05-07
Anticipated expiration: 2030-06-15

Abstract

The anti-blocking implantable drug delivery device comprises a catheter for being inserted into a blood vessel, wherein the catheter comprises an outer tube and an inner tube which are not communicated with each other, the outer tube is provided with a part sleeved on the inner tube, the part sleeved on the inner tube of the outer tube is provided with an outer outlet communicated with the blood vessel, the space between the outer tube and the inner tube is communicated with the outer outlet, the implantable drug delivery device comprises a balloon, the balloon is positioned between the inner tube and the outer tube and is only communicated with the inner tube, the balloon can be filled with liquid in the inner tube to be expanded so as to block the outer outlet, and the balloon is collapsed so as to open the outer outlet when the liquid in the inner tube is. The implantable drug delivery device can quickly and reliably realize treatment operation, and can effectively avoid the subsequent use difficulty caused by blockage of the catheter in the non-treatment period, thereby not only reducing the occurrence of complications, but also prolonging the service life of the product and reducing the treatment cost of patients.

Description

Anti-clogging implantable drug delivery device

Technical Field

The disclosure relates to the field of intravenous infusion administration treatment, in particular to an anti-blocking implantable administration device.

Background

The implanted intravenous administration device can provide a long-term central venous transfusion passage, is mainly used for the treatment of cytotoxic or irritant antitumor drug intravenous infusion, intravenous nutrition infusion and the like of cancer patients, can obviously improve the safety of the venous passage, and reduces pain caused by repeated puncture. In addition, the infusion catheter is arranged under the skin and can be kept for a long time, and the exposed parts in vitro are few, so that the implanted intravenous administration device is convenient to carry and attractive, and the life quality of a patient can be obviously improved while disease treatment is finished.

Currently, the implanted drug delivery devices used in clinical practice mainly include the following two types: first, the catheter distal opening is open; second, the catheter distal opening is a three-way valve opening. For the first, blood is easily immersed into the distal opening of the catheter, so that thrombus is hidden in the catheter to cause catheter blockage, and before use, the thrombolytic operation needs to be completed within a certain time, and risk caused by the fact that non-thrombolytic thrombus flows to the distal end of the blood vessel can also occur. For the second, the distal end of the catheter has a three-way valve, which realizes the opening and closing of the distal end of the catheter by means of automatic opening and closing of the valve, which makes the implantable drug delivery device have low reliability in preventing blood from entering the catheter and inputting drug delivery and drawing back blood.

Accordingly, there is a need for an implantable drug delivery device that effectively prevents blood from entering the catheter after a treatment procedure, while at the same time enabling rapid and reliable administration of the infusion and withdrawal of blood returns.

SUMMERY OF THE UTILITY MODEL

The present disclosure is made in view of the state of the art described above. The purpose of the present disclosure is to provide an anti-clogging implantable drug delivery device, which can effectively prevent blood from entering a catheter to cause catheter clogging after a treatment operation, and can quickly and reliably perform the treatment operations such as infusion drug delivery and blood withdrawal.

There is provided an anti-clogging implantable drug delivery device comprising a catheter for insertion into a blood vessel, the catheter comprising an outer tube and an inner tube that are not in communication with each other, the outer tube having a portion that overlies the inner tube, the portion of the outer tube that overlies the inner tube having an outer exit orifice that is in communication with the blood vessel, a space between the outer tube and the inner tube being in communication with the outer exit orifice,

the implantable drug delivery device includes a balloon positioned between the inner tube and the outer tube, the balloon communicating only with the inner tube, the balloon being inflatable by liquid filling within the inner tube to block the outer outlet, and collapsing to open the outer outlet when liquid within the inner tube is withdrawn.

Preferably, the implantable drug delivery device comprises a port body for implantation under the skin, the port body having a first volume in communication with the outer tube and a second volume in communication with the inner tube, the first and second volumes not in communication with each other, the first volume being larger than the second volume.

Preferably, the implantable drug delivery device comprises a port body for implanting under the skin, the port body has a first cavity communicating with the outer tube and a second cavity communicating with the inner tube, the first cavity and the second cavity are not communicated with each other, and an inlet of the first cavity is higher than an inlet of the second cavity.

Preferably, the implantable drug delivery device comprises a port body for implantation under the skin, the port body having a first volume in communication with the outer tube and a second volume in communication with the inner tube, the first volume and the second volume not being in communication with each other, the inner tube being inserted into the outer tube from a tube sidewall of the outer tube.

Preferably, the portion of the inner tube that is sheathed by the outer tube has an inner outlet that communicates with the balloon, the balloon having two axial ends connected to the tube side wall of the inner tube, the inner outlet being located between the two axial ends.

Preferably, the balloon is disposed around the outer circumference of the inner tube.

Preferably, the outer outlet is located on the tube side wall of the outer tube, and the distal ends of the tube side wall of the inner tube and the tube side wall of the outer tube are sealingly connected to the distal end wall of the outer tube.

Preferably, the outer tube has at least two of the outer outlets aligned or staggered in the axial direction of the conduit, and/or

The at least two outer outlets are arranged evenly spaced in the circumferential direction of the conduit.

Preferably, the balloon is bonded or welded to the inner tube.

Preferably, the distal end wall of the inner tube, the distal end wall of the outer tube and the tube side wall of the outer tube are rounded off.

The technical scheme provided by the disclosure at least has the following beneficial effects:

the balloon is used for controlling the opening and closing of the outer outlet, when single treatment is finished, liquid can be injected into the outer tube to expand the balloon, so that the outer outlet is reliably blocked, the phenomenon that the blood enters the implantable drug delivery device to cause catheter blockage is effectively prevented, and when infusion drug delivery or blood return is carried out, the liquid in the inner tube is sucked to enable the balloon to collapse, so that the outer outlet is effectively opened, liquid medicine and the like can be delivered to a blood vessel and blood return can be smoothly carried out. The implantable drug delivery device can quickly and reliably realize treatment operation, and can effectively avoid the subsequent use difficulty caused by blockage of the catheter in the non-treatment period, thereby not only reducing the occurrence of complications, but also prolonging the service life of the product and reducing the treatment cost of patients.

Drawings

Fig. 1 is a schematic view of an anti-clogging implantable drug delivery device provided by the present disclosure.

Fig. 2 is a schematic view of the port body of the implantable drug delivery device of fig. 1.

Fig. 3 is a schematic view of the anti-clogging implantable drug delivery device in a treatment state.

FIG. 4 is a schematic view of the anti-clogging implantable drug delivery device in a non-treatment state

Description of reference numerals:

1 port, 11 first port, 112 first sealing membrane, 12 second port, 122 second sealing membrane, 13 connectors, 2 catheters, 21 external tube, 210 external outlet, 22 internal tube, 23 flow channel, 220 internal outlet, 3 balloons.

Detailed Description

Exemplary embodiments of the present disclosure are described below with reference to the accompanying drawings. It should be understood that the detailed description is intended only to teach one skilled in the art how to practice the disclosure, and is not intended to be exhaustive or to limit the scope of the disclosure.

As shown in fig. 1 and 2, the present disclosure provides an implantable drug delivery device comprising a port body 1 and a catheter 2, the port body 1 being for subcutaneous implantation and having a cavity. The proximal end of the catheter 2 communicates with the cavity and the distal end is inserted into a blood vessel (vein or artery), into which drugs or the like may first enter and then be delivered via the catheter 2 to the blood vessel.

It should be understood that "proximal" as used herein refers to the end of an object that is near the operator (e.g., a physician) or upstream of the fluid flow during infusion therapy, and "distal" refers to the end of an object that is away from the operator (e.g., a physician) or downstream of the fluid flow during infusion therapy.

The catheter 2 comprises an inner tube 22 and an outer tube 21, the inner tube 22 having an outer diameter smaller than the inner diameter of the outer tube 21, the outer tube 21 having a tube side wall and a distal end wall, the distal end wall of the outer tube 21 being sealingly connected to the tube side wall so as to seal the distal end of the outer tube 21. The inner tube 22 is inserted into the outer tube 21 from the tube side wall of the outer tube 21, the tube side wall of the outer tube 21 is opened with an inner port, and the inner tube 22 extends from the distal end thereof all the way inside the outer tube 21 until it protrudes from the inner port, so that the catheter 2 has a Y-shape as a whole. The portion of the outer tube 21 from the inner junction to its distal wall is sheathed by the inner tube 22, for example the distal portion of the outer tube 21 is sheathed by the distal portion of the inner tube 22, and a flow passage 23 having an annular shape in cross section is provided between the sheathed portion of the outer tube 21 and the portion of the inner tube 22.

In this embodiment, the "distal end portion of the outer tube 21 is sleeved on the distal end portion of the inner tube 22" is taken as an example of the "outer tube 21 having a portion sleeved on the inner tube 22", and in other embodiments, the portion of the outer tube 21 sleeved on the inner tube 22 may be other portions.

The inner tube 22 has only a tube side wall and no distal end wall, and the distal end of the tube side wall of the inner tube 22 is sealingly connected to the distal end wall of the outer tube 21 to seal the distal end of the inner tube 22. The inner tube 22 is sealingly connected, e.g. welded, to the inner interface of the outer tube 21, thereby keeping the inner tube 22 and the outer tube 21 undeformed.

The port body 1 may include a first port body 11 and a second port body 12, the first port body 11 and the second port body 12 may be provided on the same base to be integrated, and the first port body 11 and the second port body 12 may have a first cavity and a second cavity, for example, cylindrical shapes, respectively, the first cavity and the second cavity may not be communicated with each other. The port body 1 may have two connectors 13 communicating with the first and second volumes, respectively, the two connectors 13 being adapted to be connected with the outer tube 21 and the inner tube 22, respectively, such that the first volume communicates with the outer tube 21 and the second volume communicates with the inner tube 22.

The port body 1 may be injection molded or machined from a material such as medical grade silicone, titanium alloy, maple, or polyetheretherketone.

The distal end portion of the outer tube 21 has an outer outlet 210, the outer outlet 210 is opened to, for example, a tube side wall of the outer tube 21, and a liquid, such as a medical liquid, received in a first receiving chamber serving as an inlet for administration of an infusion solution and for operations of withdrawing blood, etc., can be delivered to a blood vessel via the outer outlet 210 and the flow passage 23 between the outer tube 21 and the inner tube 22 in this order. The distal end of the inner tube 22 may have an inner outlet 220, the inner outlet 220 opening into the tube sidewall of the inner tube 22, for example.

The distal end walls of the inner tube 22 and the outer tube 21 are sealingly connected so that the medical fluid does not flow out of the end face of the outer tube 21 but flows entirely out of the outer outlet 210 of the outer tube 21. The distal end wall of the inner tube 22, the distal end wall of the outer tube 21 and the tube side wall of the outer tube 21 may be rounded, for example. Thus, when the catheter 2 is inserted into a blood vessel, it is possible to reduce the resistance to the catheter 2 and damage to the blood vessel, and to prevent blood from entering from the end surface of the catheter 2.

As shown in fig. 3 and 4, the implantable drug delivery device further includes a balloon 3, the balloon 3 is located between the outer tube 21 and the inner tube 22 and may correspond to the outer outlet 210, and the balloon 3 is only communicated with the inner outlet 220 and thus only communicated with the inner tube 22. Liquid, such as lock liquid, received in the second volume, can flow into the balloon 3 via the inner tube 22 and the inner outlet 220 in sequence, and the second volume serves as a path for pressurizing and depressurizing the balloon 3. The balloon 3 can be inflated by the liquid in the inner tube 22 to block the outer outlet 210 and collapsed to open the outer outlet 210 when the liquid in the inner tube 22 is withdrawn.

The tube sealing liquid is, for example, normal saline water. The balloon 3 is made of, for example, a medical grade material, such as silica gel or polyurethane.

It can be seen that the balloon 3 controls the opening and closing of the outer outlet 210, so that the balloon 3 can be inflated by injecting a liquid into the inner tube 22 after a single treatment is completed, thereby reliably blocking the outer outlet 210 and effectively preventing blood from entering the implantable drug delivery device, and that the liquid in the inner tube 22 can be sucked to collapse the balloon 3 and effectively open the outer outlet 210 during treatment or blood withdrawal, thereby enabling the delivery of a drug solution or the like to a blood vessel and the smooth blood withdrawal. The implantable drug delivery device can quickly and reliably realize treatment operation, and can effectively avoid the subsequent use difficulty caused by blockage of the catheter 2 in the non-treatment period, thereby not only reducing the occurrence of complications, but also prolonging the service life of the product and reducing the treatment cost of patients.

The balloon 3 is attached, e.g. welded or glued, to the tube side wall of the inner tube 22, so that the balloon 3 has two axial ends connected to the tube side wall of the inner tube 22, and the inner outlet 220 may be located between the two axial ends. Compared with the method of cutting off the whole part of the inner tube 22 inside the balloon 3, the method of the present embodiment is advantageous in that the balloon 3 is not easily dislocated after inflation, the end can better maintain the shape, and the outer outlet 210 can be more reliably sealed. Further, since the balloon 3 has a portion extending in the axial direction fixed to the inner tube 22, both ends in the axial direction of the balloon 3 are more uniformly stressed when the balloon 3 is filled with liquid. The above-described axially extending portion also functions to support the balloon 3 between the outer tube 21 and the inner tube 22.

It will be appreciated that the size of the balloon 3, and the size of the flow channel 23, should be such that when the balloon 3 is inflated and deformed by the side walls of the inner tube 22 and the outer tube 21, the wall portion of the balloon 3 pressed by the outer tube 21 is in sufficient contact with the outer outlet 210 to completely block the outer outlet 210.

The outer tube 21 may be provided with two outer outlets 210, and the two outer outlets 210 may be aligned in the axial direction of the catheter 2 (the axial direction of the portion of the outer tube 21 that is externally fitted over the inner tube 22) and arranged at 180 degrees intervals in the circumferential direction of the catheter 2. Such two outer outlets 210 may evenly release medical fluids or the like within the blood vessel, and minimizing the number of outer outlets 210 may be advantageous to reduce the risk of catheter occlusion.

In other embodiments, the outer tube 21 may have more than two outer outlets 210, and the outer outlets 210 may be staggered in the axial direction of the conduit 2 (the axial direction of the portion of the outer tube 21 that is sleeved on the inner tube 22), for example, the plurality of outer outlets 210 may form multiple rows that are spaced apart in the axial direction, the outer outlets 210 of different rows may be aligned or staggered in the circumferential direction, and the plurality of outer outlets 210 may be evenly spaced apart in the circumferential direction.

The inner tube 22 may have two inner outlets 220, and the two inner outlets 220 may be aligned in the axial direction of the catheter 2 and disposed 180 degrees apart in the circumferential direction of the catheter 2. The balloon 3 may be disposed around the outer circumference of the inner tube 22, and in particular, the inner tube 22 may pass through the balloon 3.

The port 1 further comprises sealing diaphragms (shown in fig. 2) comprising a first sealing diaphragm 112 covering the inlet of the first volume, which may be higher than the inlet of the second volume, and a second sealing diaphragm 122 covering the inlet of the second volume, the first sealing diaphragm 112 correspondingly being higher than the second sealing diaphragm 122, ignoring the thickness of the sealing diaphragms.

The sealing membrane prevents the liquid from escaping from the harbor body 1 and acts as a seal. The sealing septum is capable of automatically repairing and continuing to close the cavity after being pierced by, for example, an atraumatic needle and detached therefrom. The sealing diaphragm is made of, for example, silicone.

The lower inlet of the second cavity is beneficial to avoiding the pressure fluctuation of the balloon 3 caused by the external pressure acting on the second cavity, and the difference of the heights of the first cavity and the second cavity can help to identify.

The volume of the first volume may be greater than the volume of the second volume. The volume of the second cavity is small, so that the balloon 3 can keep an expanded state and cannot retract, and the volume of liquid stored in the implanted drug delivery device is small after the treatment is finished, so that the comfort of a patient can be improved.

The use method of the implantable drug delivery device is as follows.

At the time of initial use, the balloon 3 is unfilled in a collapsed state, and the outer outlet 210 is open. In this case, when the infusion is required to be administered to the patient, the first sealing membrane 112 is penetrated by a non-invasive needle to introduce the drug solution, which is transferred through the first receiving chamber and then flows into the outer tube 21 from the connector 13, enters the flow passage 23 between the outer tube 21 and the inner tube 22, and is delivered to, for example, the superior vena cava site through the outer outlet 210 for therapeutic effect. When blood is drawn back, blood flows from the outer outlet 210 back into the flow passage 23 between the outer tube 21 and the inner tube 22 and from the first volume into, for example, a syringe.

After the treatment operations such as infusion administration and blood return extraction are completed, the catheter 2 is flushed and subjected to positive pressure tube sealing operation according to the nursing requirements, then the second sealing membrane 122 is penetrated by a non-destructive needle for example, so that tube sealing liquid is input, passes through the second cavity, enters the inner tube 22 from the connector 13, and flows to the balloon 3 through the inner outlet 220 to be expanded. When the balloon 3 is expanded to be pressed by the tube sidewall of the outer tube 21, the outer outlet 210 is blocked, the atraumatic needle is removed from the second sealing diaphragm 122, and the second sealing diaphragm 122 can be automatically repaired after the atraumatic needle is removed to keep the tube sealing liquid stored in the second cavity and the inner tube 22. When the transfusion therapy is not performed, the balloon 3 is always in the expansion state, and the outer outlet 210 is always in the blocked state, so that the blood in the blood vessel is prevented from being soaked into the catheter 2 to form thrombus to cause blockage.

When the next treatment operation such as administration of infusion and blood withdrawal is required, the second sealing membrane 122 is punctured with a non-invasive needle to perform a suction operation, and the liquid in the balloon 3 is withdrawn to collapse the balloon 3. When the balloon 3 collapses to open the outer outlet 210, the above-described infusion administration operation or blood withdrawal and return operation is performed again.

As mentioned above, the circulation operation can realize multiple treatments.

Therefore, the implanted drug delivery device can realize the treatment functions of conventional drug delivery, blood extraction and return and the like, can block the outer outlet 210 from the interior of the catheter 2 after treatment is finished, prevents blood from entering and forming thrombus to cause blockage, and can perform the conventional operations of drug delivery, blood extraction and return and the like by opening the outer outlet 210 through sucking liquid in the balloon 3 when the implanted drug delivery device is used next time.

It should be understood that the above-described embodiments are exemplary only, and are not intended to limit the present disclosure. Various modifications and alterations of the above-described embodiments may be made by those skilled in the art in light of the teachings of this disclosure, without departing from the scope of this disclosure.

Claims

1. An anti-clogging implantable drug delivery device comprising a catheter (2) for insertion into a blood vessel, the catheter (2) comprising an outer tube (21) and an inner tube (22) that are not in communication with each other, the outer tube (21) having a portion that is externally fitted over the inner tube (22), the portion of the outer tube (21) that is externally fitted over the inner tube (22) having an outer outlet (210) that is in communication with the blood vessel, the space between the outer tube (21) and the inner tube (22) being in communication with the outer outlet (210), characterized in that:

the implantable drug delivery device comprises a balloon (3), wherein the balloon (3) is positioned between the inner tube (22) and the outer tube (21), the balloon (3) is only communicated with the inner tube (22), the balloon (3) can be filled with liquid in the inner tube (22) to expand so as to block the outer outlet (210), and the balloon (3) collapses to open the outer outlet (210) when the liquid in the inner tube (22) is withdrawn.

2. The anti-clogging implantable drug delivery device according to claim 1, characterized in that it comprises a port body (1) for subcutaneous implantation, said port body (1) having a first volume communicating with said outer tube (21) and a second volume communicating with said inner tube (22), said first and second volumes not communicating with each other, said first volume having a larger volume than said second volume.

3. The anti-clogging implantable drug delivery device according to claim 1, characterized in that it comprises a port body (1) for subcutaneous implantation, said port body (1) having a first volume communicating with said outer tube (21) and a second volume communicating with said inner tube (22), said first and second volumes not communicating with each other, the inlet of said first volume being higher than the inlet of said second volume.

4. The anti-clogging implantable drug delivery device according to claim 1, characterized in that it comprises a port body (1) for subcutaneous implantation, said port body (1) having a first volume communicating with said outer tube (21) and a second volume communicating with said inner tube (22), said first and second volumes not communicating with each other, said inner tube (22) being inserted into said outer tube (21) from the tube side wall of said outer tube (21).

5. The anti-clogging implantable drug delivery device according to claim 1, wherein the portion of the inner tube (22) that is sheathed by the outer tube (21) has an inner outlet (220), the inner outlet (220) being in communication with the balloon (3), the balloon (3) having two axial ends connected to the tube sidewall of the inner tube (22), the inner outlet (220) being located between the two axial ends.

6. The anti-clogging implantable drug delivery device according to claim 5, wherein the balloon (3) is disposed around the outer circumference of the inner tube (22).

7. The anti-clogging implantable drug delivery device according to claim 1, wherein the outer outlet (210) is located at a tube sidewall of the outer tube (21), and a distal end of the tube sidewall of the inner tube (22) and a distal end of the tube sidewall of the outer tube (21) are sealingly connected to a distal end wall of the outer tube (21).

8. The anti-clogging implantable drug delivery device according to claim 1, wherein the outer tube (21) has at least two of the outer outlets (210), the at least two outer outlets (210) being aligned or staggered in an axial direction of the catheter (2), and/or

The at least two outer outlets (210) are arranged evenly spaced in the circumferential direction of the conduit (2).

9. The anti-clogging implantable drug delivery device according to claim 1, wherein the balloon (3) is bonded or welded to the inner tube (22).

10. The anti-clogging implantable drug delivery device according to claim 1, wherein the distal end wall of the inner tube (22), the distal end wall of the outer tube (21), and the tube side wall of the outer tube (21) are rounded off.