KR102262342B1 - Drug delivery device and drug delivery method using the same - Google Patents

Abstract

The present invention relates to a drug delivery device and a drug delivery method using the same, wherein the drug delivery device according to an embodiment of the present invention has an injection port 11 and is inserted into the body through the urethra in a contracted state, and in the renal pelvis. The balloon 10 is fixed by inflating; The drug layer 20 is coated on the outer surface of the balloon 10, dissolved by urine and released; and a catheter 30 detachably coupled to the balloon 10 and inflating the balloon 10 by injecting the fluid 1 through the inlet 11 .

Description

Drug delivery device and drug delivery method using the same

The present invention relates to a drug delivery device and a drug delivery method using the same, and more particularly, to a drug delivery technology disposed in the renal pelvis to release a drug.

The renal pelvis is the innermost part of the kidney, where urine is temporarily collected and stored in the urinary bladder via the ureter. excreted Such malignant tumors in the renal pelvis are called renal pelvic cancer, and the treatment varies greatly depending on whether the cancer has metastasized. Surgical treatment methods include radical surgery and conservative surgery. Curative surgery is a method commonly used in renal pelvic cancer by removing all parts of the kidney, ureter, and bladder wall on the side where the cancer occurs. On the other hand, in the case of bladder cancer, cancer progression or recurrence is prevented through intravesical drug injection after resection of a tumor in the bladder. As disclosed in the patent documents of the following prior art documents, the intravesical drug injection technique injects a specific drug into the bladder through a thin urethral catheter and then injects the drug so that the drug stays in the patient's bladder for a certain period of time with the urethral catheter removed. It is therapy. In the case of renal pelvic cancer, it is necessary to perform intrapelvic injection as in bladder drug injection while excising and following up the tumor in the renal pelvis, but up to now, it is a medical device that can easily proceed with intrarenal drug injection while alleviating the pain and shame of the patient. is not being developed.

Accordingly, there is an urgent need to develop a medical device for drug injection in the renal pelvis.

US 10-2004-0009016 A

The present invention is to solve the problems of the prior art described above, and one aspect of the present invention is that a balloon detachably coupled to a catheter and coated with a drug on the outer surface is inserted into the renal pelvis in a contracted state and then in an inflated state. An object of the present invention is to provide a drug delivery device that is fixed within and releases a drug.

Another aspect of the present invention is to provide a drug delivery device in which different drugs are coated on the balloon in a multi-layered structure to release appropriate drugs for each treatment period.

Another aspect of the present invention is that a plurality of balloons each coated with a drug are arranged in a multi-structure and configured to sequentially rupture the balloon from the outside, so that a specific drug can be released in consideration of the patient's condition and treatment time To provide a delivery device.

A drug delivery device according to an embodiment of the present invention includes: a balloon having an injection port, inserted into the body through the urethra in a contracted state, and fixed by expanding in the renal pelvis; a drug layer that is coated on the outer surface of the balloon and is dissolved and released by urine; and a catheter detachably coupled to the balloon and inflating the balloon by injecting a fluid through the inlet.

In addition, in the drug delivery device according to an embodiment of the present invention, the drug layer may have a multi-layer structure in which different drugs are sequentially coated.

In addition, in the drug delivery device according to an embodiment of the present invention, it is disposed on the outer surface of the balloon, and a valve unit to block the fluid injected into the balloon from being discharged through the inlet; may further include .

In addition, in the drug delivery device according to an embodiment of the present invention, the valve unit, the body having a passage communicating with the inlet so that the fluid is injected into the balloon, or the catheter is inserted; And has elasticity, is formed in the form of a thin film, and one edge is coupled to the inner wall of the passage to close the passage, and when the fluid is injected or bent by an external force applied by the inserted catheter, the external force is removed may include a restored valve membrane.

In addition, in the drug delivery device according to an embodiment of the present invention, a rupturer disposed on the outer surface of the balloon, receiving a signal from the outside to rupture the balloon; may further include.

In addition, in the drug delivery device according to an embodiment of the present invention, the rupture device may include a heating element that receives energy wirelessly and generates heat.

In addition, in the drug delivery device according to an embodiment of the present invention, the balloon, a plurality of pieces, may be arranged in a multi-structure in which one is disposed inside the other.

In addition, in the drug delivery device according to an embodiment of the present invention, the catheter is inserted into the plurality of balloons through the inlet and coupled thereto, and a plurality of discharge holes are provided in the insertion area inserted into each of the balloons. provided so that the fluid can be discharged through the discharge hole.

In addition, in the drug delivery device according to an embodiment of the present invention, the guide tube is formed in a hollow tube shape into which the catheter is inserted, one end is coupled to the balloon so as to communicate with the inlet; It may further include a coupling part for removably coupling one end of the guide tube and the balloon: and a coupling releasing part for separating the coupling part.

In addition, in the drug delivery device according to an embodiment of the present invention, the coupling portion is bonded while integrally wrapping one end of the guide tube and the balloon, and the uncoupled portion is in contact with the coupling portion, and the applied current and a heating wire for disassembling the coupling part by generating heat.

On the other hand, the drug delivery method according to an embodiment of the present invention comprises the steps of (a) preparing the drug delivery device; (b) inserting the catheter of the drug delivery device through the urethra, placing the balloon of the drug delivery device in a deflated state, in the renal pelvis; (c) injecting a liquid into the balloon through the catheter, inflating the balloon; and (d) separating the inflated balloon and the catheter.

In addition, in the drug delivery method according to an embodiment of the present invention, after the step (d), the drug layer of the drug delivery device coated on the outer surface of the inflated balloon may be dissolved in urine and the drug may be released. .

In addition, in the drug delivery method according to an embodiment of the present invention, after step (d), sequentially rupturing from the one disposed at the outermost of the plurality of balloons of the drug delivery device according to a predetermined time; may include more.

The features and advantages of the present invention will become more apparent from the following detailed description taken in conjunction with the accompanying drawings.

Prior to this, the terms or words used in the present specification and claims should not be construed in a conventional and dictionary meaning, and the inventor may properly define the concept of the term to describe his invention in the best way. It should be interpreted as meaning and concept consistent with the technical idea of the present invention based on the principle that there is.

According to the present invention, the balloon in the deflated state is combined with the catheter and moved into the renal pelvis, and in the expanded state, separated from the catheter and fixed in the renal pelvis, because the drug coated on the balloon is released while dissolved in the urine. Drug injection can be performed more easily.

In addition, different drugs are coated on the balloon in a multi-layered structure, and further, a plurality of balloons are arranged to be sequentially ruptured from the outermost part by the selection of the medical staff in a multi-structured state, so that the appropriate drug for each patient's condition and treatment time can emit.

1 is a side view showing a drug delivery device according to a first embodiment of the present invention.
2 is a cross-sectional view illustrating a process in which the balloon of the drug delivery device according to the first embodiment of the present invention is inflated.
3 is a cross-sectional view showing a drug delivery device according to a second embodiment of the present invention.
4 is a side view showing a drug delivery device according to a third embodiment of the present invention.
5 is a cross-sectional view illustrating a drug delivery device according to a fourth embodiment of the present invention.
6 is a side view showing a drug delivery device according to a fifth embodiment of the present invention.
7 is a flowchart of a drug delivery method according to an embodiment of the present invention.

The objects, specific advantages and novel features of the present invention will become more apparent from the following detailed description taken in conjunction with the accompanying drawings and preferred embodiments. In the present specification, in adding reference numbers to the components of each drawing, it should be noted that only the same components are given the same number as possible even though they are indicated on different drawings. Also, terms such as “first” and “second” are used to distinguish one component from another, and the component is not limited by the terms. Hereinafter, in describing the present invention, detailed descriptions of related known technologies that may unnecessarily obscure the gist of the present invention will be omitted.

Hereinafter, preferred embodiments of the present invention will be described in detail with reference to the accompanying drawings.

1 is a side view showing a drug delivery device according to a first embodiment of the present invention, Figure 2 is a cross-sectional view showing a process in which the balloon 10 of the drug delivery device according to the first embodiment of the present invention is inflated .

1 to 2, the drug delivery device according to the first embodiment of the present invention is provided with an injection port 11, is inserted into the body through the urethra in a contracted state, and is fixed by expanding in the renal pelvis. being a balloon (10); The drug layer 20 is coated on the outer surface of the balloon 10, dissolved by urine and released; and a catheter 30 detachably coupled to the balloon 10 and inflating the balloon 10 by injecting the fluid 1 through the inlet 11 .

The present invention relates to a drug delivery device for injecting a drug into the renal pelvis. When a tumor occurs in the renal pelvis, where urine temporarily collects as the innermost part of the kidney, the tumor is usually excised according to a radical surgical method, followed by drug injection, but until now The development of a medical device capable of conveniently administering a drug in the renal pelvis has not been developed. Accordingly, a drug delivery device according to the present invention capable of effectively injecting a drug into the renal pelvis has been devised.

Specifically, the drug delivery device according to the present invention includes a balloon 10 , a drug layer 20 , and a catheter 30 .

Here, the balloon 10 is formed in the form of a sealed bag, and has an injection port 11 through which the fluid 1 is injected so that the fluid 1 is inflated when the fluid 1 is injected therein. The fluid 1 injected into the balloon 10 may be a liquid as well as a gas. The balloon 10, in a contracted state, is inserted into the body through the urethra while being guided by a catheter 30 to be described later, moves into the renal pelvis, and is inflated within the renal pelvis to stay fixed in the renal pelvis. On the other hand, the outer surface of the balloon 10 is coated with the drug layer 20, the injection port 11 side is coupled to the end of the catheter (30).

The drug layer 20 is a thin film formed by coating a predetermined drug 21 on the outer surface of the balloon 10 . Here, the drug 21 is a renal cancer-related drug such as an anticancer agent or an antibiotic, and there is no particular limitation on the type thereof. The drug layer 20 is released while being dissolved by urine in the renal pelvis. Meanwhile, the drug layer 20 may include other additional materials for coating the drug 21 or controlling the drug release rate in addition to the drug 21 .

The catheter 30 is inserted through the urethra and is formed of a thin, long and flexible hollow tube member to inject the fluid 1 through the inside. Here, one end of the catheter 30 from which the fluid 1 is discharged is coupled to the balloon 10 so as to communicate with the inlet 11 , wherein the coupled catheter 30 and the balloon 10 are separable from each other. Therefore, when the balloon 10 is inserted into the renal pelvis, the fluid 1 is injected through the catheter 30 to inflate the balloon 10, and after the balloon 10 is sufficiently inflated, the catheter 30 is the balloon ( 10) and removed from the body. Accordingly, the catheter 30 is removed and the balloon 10 in an inflated state is fixed in the renal pelvis, and the drug layer 20 is dissolved by the urine collected in the renal pelvis and the drug 21 is released.

Overall, according to the present invention, the balloon 10 in the deflated state is coupled with the catheter 30 and moved into the renal pelvis, and separated from the catheter 30 in the expanded state and fixed in the renal pelvis, the balloon 10 ) because the drug 21 coated in the urine is released as it dissolves, so the drug 21 in the renal pelvis can be injected more easily.

3 is a cross-sectional view showing a drug delivery device according to a second embodiment of the present invention.

Referring to FIG. 3 , the drug delivery device according to the second embodiment of the present invention may further include a valve unit 40 to block the reverse flow of the fluid 1 injected into the balloon 10 .

When the fluid 1 is injected into the balloon 10, the injected fluid 1 may be discharged through the open inlet 11, so to prevent this, the valve unit 40 is installed on the outer surface of the balloon 10. can be placed in

As an embodiment, the valve part 40 may be composed of a body 41 and a valve membrane 43 .

Here, the body 41 is a member having a passage communicating with the inlet 11 . The passage of the body 41 communicating in communication with the inlet 11 provides a space in which the fluid 1 is injected into the balloon 10 or the catheter 30 is inserted. This body 41 may be formed in the form of a protrusion extending from the outer surface of the balloon 10 around the inlet 11 of the balloon 10 , or may be separately manufactured and coupled to the balloon 10 .

The valve membrane 43 is formed in a thin film form as a material having elasticity, and is disposed to cross the passage of the main body 41 to close the passage. At this time, since the entire edge of the valve membrane 43 is not coupled to the inner wall of the passage, but only one side of the edge is coupled to the inner wall of the passage, the fluid 1 or the catheter 30 passes through the passage. When this is done, it is in contact with the injected fluid 1 or the inserted catheter 30 and is bent in the direction of the balloon 10 by the external force applied at this time. However, when the external force is removed, the valve membrane 43 is restored to its original state by elasticity, thereby closing the passage again. Accordingly, once the fluid 1 is injected into the balloon 10 , the passage of the body 41 is blocked by the valve membrane 43 to block the backflow of the fluid 1 .

On the other hand, the valve unit 40 may function to connect the balloon 10 and the catheter 30 . Specifically, by inserting the distal end of the catheter 30 into the valve portion 40, it can be coupled to the balloon (10). Here, the stepped 31 protruding outwardly on the outer surface of the catheter 30 may be formed so that the region into which the catheter 30 is inserted is limited. Therefore, the catheter 30 is inserted along the passage of the valve unit 40, the step 31 is in contact with the valve unit 40, the catheter 30 is no longer inserted. This step 31, when the balloon 10 is inserted into the body, the catheter 30 is unintentionally inserted into the balloon 10 to prevent damage to the balloon (10).

4 is a side view showing a drug delivery device according to a third embodiment of the present invention.

As shown in FIG. 4 , the drug delivery device according to the third embodiment of the present invention may further include a rupturer 50 for rupturing the balloon 10 .

The rupturer 50 is provided to rupture the balloon 10 when all of the drug is released from the drug layer 20 or no more drug release is required. The balloon 10 ruptured by this is discharged to the outside of the body through urine. Here, the rupturer 50 is disposed on the outer surface of the balloon 10, and is configured to rupture the balloon 10 by receiving a predetermined signal from the outside.

In one embodiment, the rupture device 50 may be implemented as a heating element that receives energy wirelessly from an induction heating device outside the body and generates heat. Here, the induction heating device generates an electromagnetic wave under the control of a predetermined voltage or current, and the alternating nature of the generated electromagnetic wave causes a periodic magnetic flux change in the heating element, thereby generating an induced current on the surface of the heating element and the heating element generates heat. And, the heat generated in this way will eventually rupture the balloon (10). Therefore, the medical staff can control the drug injection by rupturing the balloon 10 in consideration of the patient's condition and treatment time.

However, the blower 50 is not necessarily limited to the heating element, and there is no particular limitation as long as it is configured to selectively pop the balloon 10 .

On the other hand, it is necessary to inject different drugs for each period during the treatment process. For this purpose, the drug layer 20 according to the present invention may have a multilayer structure in which different drugs are sequentially coated. That is, on the first coating layer coated with the first drug, the second coating layer coated with the second drug is sequentially coated to form a multi-layered drug layer 20 . In this case, since the drug is sequentially released from the outermost coating layer, it is possible to release the drug suitable for each treatment period.

In addition, in order for the medical staff to control the release of various drugs, a plurality of balloons 10 may be used, which will be described in more detail below.

5 is a cross-sectional view illustrating a drug delivery device according to a fourth embodiment of the present invention.

With reference to FIG. 5, a description will be given of a drug delivery device in which a plurality of balloons 10 are arranged in a multi-layer structure.

Here, the plurality of balloons 10 are each arranged in a form in which the drug layer 20 is coated as a balloon 10, in which the other one (10b) is disposed inside any one (10a). In this case, the drug layer 20 may be made of a single drug or a multi-layered structure coated with different drugs. On the other hand, each balloon 10 has a valve portion 40, and / or a rupturer 50 may be disposed.

Here, the catheter 30 is coupled while being inserted into a plurality of the balloons 10 through the inlet 11, and the insertion region of the catheter 30 inserted into each balloon 10 communicates with the internal hollow. A plurality of discharge holes 33 are formed. Therefore, the fluid 1 injected along the inner hollow of the catheter 30 is discharged into each balloon 10 through one end and the discharge hole 33 of the catheter 30 and the deflated balloon 10 . inflate

In this case, the medical staff may selectively rupture from the outermost balloon 10a through the rupturer 50, thereby releasing the necessary drug at an appropriate time.

On the other hand, after the balloon 10 is inflated, the separation of the balloon 10 and the catheter 30 may be made in a manner of pulling the catheter 30 inserted into the inlet 11 or the valve part 40 to remove it. . Since the balloon 10 is inflated larger than the ureter in the renal pelvis, the balloon 10 inflated when pulling the catheter 30 does not fall out in the renal pelvis and only the catheter 30 can be separated and removed from the balloon 10 have.

Alternatively, it is possible to separate the catheter 30 and the balloon 10 in a different way from the above method, which will be described below.

6 is a side view showing a drug delivery device according to a fifth embodiment of the present invention.

As shown in FIG. 6 , the drug delivery device according to the present invention may further include a guide tube 60 , a coupling part 70 , and a coupling releasing part 80 .

Here, the guide tube 60 is a member formed in the shape of a hollow tube into which the catheter 30 is inserted, and one end thereof is coupled to the balloon 10 so as to communicate with the inlet 11 of the balloon 10 . On the other hand, one end of the catheter 30 inserted into the guide tube 60 also communicates with the inlet 11 of the balloon 10 . The coupling part 70 is a member for separably coupling one end of the guide tube 60 and the balloon 10 , and by being separated by the coupling releasing unit 80 , the combination of the balloon 10 and the guide tube 60 . this is released

Here, the coupling part 70 may be a member that is adhered while integrally wrapping one end of the guide tube 60 and the balloon 10 . As an example, the coupling part 70 may be formed in the form of an adhesive tape. On the other hand, the decoupling unit 80 may include a hot wire 81 in contact with the coupling unit 70 . In this case, when a current is applied to the heating wire 81 to generate heat, the coupling portion 70 in contact therewith is melted, and thus the coupling portion 70 may be separated. At this time, since the region other than the coupling portion 70 may be melted by the heating wire 81 , the outer surface of the heating wire 81 in contact with the area other than the coupling portion 70 may be surrounded by the covering 83 .

Hereinafter, a drug delivery method using the drug delivery device according to the present invention will be described. As described above for the drug delivery device according to the present invention, the description of overlapping matters will be omitted or simply described.

7 is a flowchart of a drug delivery method according to an embodiment of the present invention.

As shown in Figure 7, the drug delivery method according to an embodiment of the present invention, (a) preparing the drug delivery device according to the present invention (S100); (b) inserting the catheter of the drug delivery device through the urethra, placing the balloon of the drug delivery device in a contracted state, in the renal pelvis (S200); (c) injecting a liquid into the balloon through the catheter, inflating the balloon (S300); and (d) separating the inflated balloon and the catheter (S400).

Specifically, in the drug delivery method according to an embodiment of the present invention, the drug delivery device preparation step (S100), the balloon arrangement step (S200), the balloon inflation step (S300), and the catheter separation step (S400) are performed.

In the drug delivery device preparation step (S100), the aforementioned drug delivery device is prepared.

The balloon placement step (S200) is a step of placing the balloon in the renal pelvis, by inserting the catheter coupled to the balloon in the deflated state through the urethra to move the balloon into the renal pelvis.

In the balloon inflation step (S300), the liquid is injected into the balloon in the contracted state moved into the renal pelvis. At this time, the liquid is injected into the balloon through the interior of the catheter.

The catheter separation step (S400) is a step of separating the catheter from the balloon, and the catheter is separated after the balloon is inflated and fixed in the renal pelvis. At this time, as described above, the catheter separation may be performed by pulling the catheter or operating a disengagement unit.

When the catheter is separated in this way, the drug layer coated on the outer surface of the inflated balloon is dissolved by the urine collected in the renal pelvis and the drug is released.

On the other hand, according to the fourth embodiment, when using a drug delivery device in which a plurality of balloons are arranged in a multi-structure, after the catheter separation step (S400), it is disposed at the outermost of the plurality of balloons according to a predetermined time It is possible to control the drug released by rupturing sequentially from the first one.

Although the present invention has been described in detail through specific examples, this is for the purpose of describing the present invention in detail, and the present invention is not limited thereto, and by those of ordinary skill in the art within the technical spirit of the present invention. It is clear that the modification or improvement is possible.

All simple modifications and variations of the present invention belong to the scope of the present invention, and the specific scope of protection of the present invention will be made clear by the appended claims.

1: fluid 10: balloon
11: injection port 20: drug layer
21: drug 30: catheter
31: step 33: exhaust hole
40: valve part 41: body
43: valve membrane 50: rupture
60: guide tube 70: coupling part
80: uncoupling part 81: hot wire
83: cloth

Claims (13)

a balloon having an inlet, inserted into the body through the urethra in a contracted state, and fixed by expanding in the renal pelvis;
a drug layer that is coated on the outer surface of the balloon and is dissolved and released by urine; and
A catheter detachably coupled to the balloon and inflating the balloon by injecting a fluid through the inlet port;
The drug delivery device further comprising a; is disposed on the outer surface of the balloon, and receives a signal from the outside to rupture the balloon.
The method according to claim 1,
The drug layer is a drug delivery device comprising a multi-layer structure in which different drugs are sequentially coated.
The method according to claim 1,
The drug delivery device further comprising a; disposed on the outer surface of the balloon, the valve unit for blocking the fluid injected into the balloon from being discharged through the inlet.
4. The method according to claim 3,
The valve unit,
a body having a passage in communication with the inlet so that the fluid is injected into the balloon, or the catheter is inserted; and
It has elasticity, is formed in the form of a thin film, and one edge is coupled to the inner wall of the passage to close the passage, and is bent by the external force applied by the fluid to be injected or the catheter to be inserted, and then restored when the external force is removed A drug delivery device comprising a valve membrane.
delete The method according to claim 1,
the rupturer,
A drug delivery device comprising a; a heating element that receives energy wirelessly and generates heat.
The method according to claim 1,
The balloon is, in multiple pieces, a drug delivery device arranged in a multi-structure in which one is disposed inside the other.
8. The method of claim 7,
The catheter is inserted into and coupled to a plurality of the balloons through the inlet, and a plurality of discharge holes are provided in the insertion region inserted into each of the balloons to discharge the fluid through the discharge holes. .
The method according to claim 1,
a guide tube formed in the shape of a hollow tube into which the catheter is inserted, and coupled to the balloon so that one end communicates with the inlet;
A coupling part for detachably coupling one end of the guide tube and the balloon: and
A drug delivery device further comprising a; a coupling releasing unit that separates the coupling unit.
10. The method of claim 9,
The coupling portion is bonded while integrally wrapping one end of the guide tube and the balloon,
The decoupling unit,
A drug delivery device comprising a; a heating wire that is in contact with the coupling part and generates heat by the applied current to disassemble the coupling part.
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