DEVICE FOR DELIVERING AEROSOLIZED MEDICATION TO A PART OF THE BODY - Patent application

Abstract

A device for delivering an aerosolized medicament to a part of the body, comprising a nozzle (100) including a head portion extending distally within an elongate shaft (108), the head portion including: a piezoelectric transducer (104, 106) mounted between conductive electrode disks (103, 105) for generating capillary waves in a liquid film that causes atomization of the medicament as it passes through the nozzle (100), an opening (101) in the nozzle (100) to which a tube (112) is connected, the opening (101) passing through a passageway (300) in the elongate shaft (108) and through the piezoelectric transducers (104, 106) and the conductive electrode disks (103, 105) to allow passage of the medicament received through the tube (112); The elongate shaft (108) supports a body member (107) at its operable proximal end and has an opening (109) through which the medicament is dispensed.

Description

Technical Field

[0001] The present invention relates to the field of biomedical engineering. In particular, the present invention relates to an apparatus for delivering an aerosolized drug to a part of the body.

Background Art

[0002] Chemotherapy is the use of drugs to destroy cancer cells. Chemotherapy usually exerts its effect by suppressing the growth and division of cancer cells and preventing them from multiplying. Cancer cells usually grow and divide faster than normal cells, so chemotherapy has a greater effect on cancer cells. In chemotherapy, many drugs need to be directly injected into the vein, which is called intravenous administration (IV therapy). Compared with intravenous administration, the drug concentration in the abdominal cavity increases several times in intraperitoneal administration. Currently, there is increasing evidence from clinical studies indicating that IP chemotherapy is beneficial for survival in various tumor types such as ovarian cancer, breast cancer, gastric cancer, and colorectal cancer. The effectiveness of intraperitoneal (IP) chemotherapy is limited due to poor distribution in the abdominal cavity and low tissue permeability. Therefore, a new method for administering intraperitoneal chemotherapy into the abdominal cavity is needed. In the prior art called pressurized intraperitoneal aerosol chemotherapy (PIPAC), a chemotherapeutic agent is administered by laparoscopic access using two balloon trocars in an operating room equipped with a laminar air flow. In the first stage, the peritoneum at room temperature is established at a pressure of 12 mmHg. In the second stage, a cytotoxic solution (about 10% of the normal systemic dose) is aerosolized into the abdominal cavity with a pressure injector and maintained for 30 minutes. In the third stage, the aerosol is removed with a closed suction system. However, it is necessary to depart from the prior art of delivering aerosols under pressure. The prior art mechanisms have to rely on third - party pressure for delivery and are thus inefficient. These third - party pressure delivery mechanisms are injectors that generate the pressure to deliver the drug to the prior art nozzles. These pressure injectors are bulky devices and are typically available in larger - scale hospitals and are mainly used as radiation injections to patients in CT, MRI, and CATHLAB departments. Therefore, in small - scale hospitals without pressure injectors, such treatments are limited. There is a need for devices, mechanisms, instruments, and / or systems that do not rely on pressure and / or pressure injectors and / or third - party equipment for delivery. Objects of the Invention

[0003] An object of the present invention is to provide a new method for administering intraperitoneal chemotherapy into the peritoneal cavity. Another object of the present invention is to provide a device for delivering chemotherapeutic drugs in an aerosolized form to the abdomen of a palliative patient, wherein the drug delivery is of an average size below nanometers. Yet another object of the present invention is to provide a device for delivering chemotherapeutic drugs in an aerosol form under ultrasound. Still another object of the present invention is to provide an easier delivery mechanism for delivering chemotherapeutic drugs to the abdomen of a palliative patient. Still another object of the present invention is to provide safe operability of the device to ensure the safety of on - site OT / OR personnel while delivering aerosolized chemotherapeutic drugs to the abdomen. Still another object of the present invention is to provide the possibility of safe maneuverability of the drug delivery nozzle while delivering aerosolized chemotherapeutic drugs for better reach within the peritoneal cavity. Still another object of the present invention is to provide a device that does not rely on pressure and / or pressure injectors and / or any third - party device for delivery. Yet another object of the present invention is to provide an apparatus that can be conveniently used even in a small-scale hospital.

Summary of the Invention

[0004] According to the present invention, there is provided an apparatus for delivering an aerosolized drug to a part of the body, the apparatus comprising: - A nozzle including a head portion extending distally within an elongated shaft, the head portion including: o One or more piezoelectric transducers mounted between a pair of conductive electrode disks, configured to generate capillary waves in a liquid film that cause atomization of the drug as it passes through the nozzle; o An opening at an operable proximal end of the nozzle to which a tube is connected, the opening communicating with a passageway included in the elongated shaft and passing through the piezoelectric transducer and the conductive electrode disk to allow passage of the drug received through the tube; and - The elongated shaft supports a body member at its operable proximal end and has an opening at its operable distal end, and the drug is received through the tube, passes through the passageway, and is dispensed from the opening. In at least one embodiment, the piezoelectric vibrator is a disk-shaped piezoelectric vibrator. In at least one embodiment, the body member is a cylindrical body member configured such that its flat operating upper surface supports the nozzle. In at least one embodiment, a fastening mechanism for holding the piezoelectric vibrator from its operating upper surface is provided on the operating upper surface of the nozzle. In at least one embodiment, a body member for holding the piezoelectric vibrator from its operable bottom is provided at the operable bottom of the nozzle. In at least one embodiment, the tube is connected to the nozzle through the opening by a luer connector. In at least one embodiment, the tube is a gravity feed tube. In at least one embodiment, a cable applies a potential to the piezoelectric transducer. In at least one embodiment, the cylindrical body member extends away from the disk and forms an elongated shaft having a diameter substantially smaller than the diameter of the cylindrical body member. In at least one embodiment, a conical surface is provided adjacent to the opening, and the conical surface tapers to be narrowest adjacent to the opening of the elongated shaft. In at least one embodiment, a step is provided at an operable distal end of the elongated shaft adjacent to the opening. In at least one embodiment, a controller is provided for controlling the frequency of the piezoelectric transducer, and by this piezoelectric transducer, before being dispensed from the opening, the drug is atomized from a liquid form into a nanoparticle mist. In at least one embodiment, the operating frequency of the device is in the range of 20 - 80 KHz.

Brief Description of the Drawings

[0005] Next, the present invention will be described in relation to the accompanying drawings. FIG. 1 is an isometric view of a nozzle of the device of the present invention. FIG. 2 is a top view of the nozzle shown in FIG. 1. FIG. 3 is a cross-sectional view showing the main elements of a nozzle configured according to the present invention. FIG. 4 is a block diagram for the operation of the device of the present invention. FIG. 5 is a diagram showing that smaller particle sizes in the range of 46 nm to 176 nm enhance the absorption of drugs in tissues. FIG. 6 is a diagram showing that as the particle diameter of the drug decreases, the penetration depth of the drug into the tissue increases up to 800 μm. Detailed Description of the Invention

[0006] According to the present invention, there is provided a device for delivering an aerosolized drug to a part of the body. This device of the present invention typically facilitates a new method in the application of administering intraperitoneal (IP) chemotherapy in the form of an aerosol into the peritoneal cavity. Figure 1 is an isometric view of the nozzle. Figure 2 is a top view of the nozzle shown in Figure 1. Figure 3 is a cross-sectional view showing the main elements of the nozzle configured according to the present invention. In at least one embodiment, the device consists of a nozzle (100). The nozzle (100) is composed of one or more piezoelectric transducers (104, 106) that form capillary waves in the liquid film, which result in atomization of the drug while passing through the nozzle (100). Typically, the nozzle (100) is composed of one or more disk-shaped piezoelectric transducers (104, 106) mounted between a pair of conductive electrode disks (103, 105). The potential is applied through an RF coaxial cable (113). Referring to the drawings, particularly FIG. 1, the nozzle 100 according to the present invention is illustrated. The nozzle (100) forming the head portion comprises disk-shaped piezoelectric vibrators (104, 106) attached between a pair of conductive electrode disks (103, 105) and the flat surface of a cylindrical body member (107) (which is a support member). A potential is applied via an RF coaxial cable (113). The cylindrical body member (107) and the fastening mechanism (102) are holders (upper and lower) for the piezoelectric vibrators (104, 106). There is an opening (101) in the rear body member (111) of the nozzle (100), and through this opening, a tube (112) (which may be a drip set) is connected with the aid of a luer connector. There is a passage (300) through which the drug flows in the opening (101). The cylindrical body member (107) extends away from the disks (103, 105) and forms an elongated shaft (108) having a diameter substantially smaller than the diameter of the cylindrical body member (107). An opening (109) is provided at the distal end of the nozzle (100), i.e., the free end of the elongated shaft (108) (the nozzle stem), and the drug is discharged therefrom. A conical surface (110) is provided adjacent to the opening (109), and the conical surface (110) is tapered so as to be the narrowest adjacent to the opening (109) of the elongated shaft (108). For the correlation between the flow rate and the nozzle, the conical surface (110) of the nozzle is sandblasted to roughen the surface, thereby reducing the cohesive force between liquid atoms, and as a result, realizing fine atomization at an even higher flow rate. Referring to FIG. 3, the passage (300) within the elongated shaft (108) allows the drug to flow before being dispensed from the opening (109). Reference numeral 301 refers to the curvature of the nozzle (100) to accommodate the change in diameter from the cylindrical body member (107) to its connected elongated shaft (108). A step (302) is provided at the distal end. In at least one embodiment, the device comprises a controller that can be used to control the frequency of the piezoelectric transducer (104), and this controller can atomize the diluted drug from a liquid form into a nanoparticle mist and spray / deliver it into the abdominal cavity via the nozzle (100) of the present invention. The nozzle is adapted to the controller and can be customized or made to order to be specialized for a particular application. The size of the particles generated by the device of the present invention depends on the frequency, surface tension, and viscosity of the liquid. Since the particle diameter is inversely proportional to the frequency, the frequency can be increased to reduce the particle diameter. In this device, the liquid does not flow out from a small orifice, but rather the ultrasonic wave flows through a large flow path that generates the aerosol. In at least one embodiment, the nozzle (100) is connected to the controller unit via a coaxial RF cable (113), and a potential is applied through this cable. The conical surface (110) is connected through a luer connector connected to the nozzle (100). There is a cylindrical body member (107) and a fixing mechanism (102) as the holders for the piezoelectric vibrators (104, 106). There is an opening (101) in the rear body member (111) of the nozzle (100), and through this opening, the tube (112) is connected with the help of a luer connector. The nozzle stem (108) has a conical surface (110) at its operating side distal end, and the narrowest part of the nozzle stem (108) is adjacent to the opening (109). Reference numeral 300 indicates the passage for the flow of the drug. In at least one embodiment, the operation by the control device starts the identification of the nozzle (100). At this stage, the state of the nozzle, i.e., whether it has already been used or is a new nozzle (100), is checked. When the identification phase is confirmed again and a key is pressed, the controller starts the power supply to the nozzle (100). The pinch valve in the tube (112) opens, and the drug starts to be sprayed from the tip of the nozzle (100). Normally, the operating frequency of this device ranges from 20 to 80 KHz. In at least one embodiment, when using the device of the present invention, since the drug flows in the tube (112) under gravity, a pressure injector or a third - party device is not required. The device of the present invention is configured to generate and deliver an aerosol under ultrasonic waves. Compared with the prior art, this is much more effective, and the setup and delivery are much easier. This device does not rely on a third - party pressure injector. Since the procedures related to palliative care are repetitive procedures, this device can reduce costs and is thus more user - friendly because it is an independent and third - party - independent device. Preferably, RFID technology is used to prevent multiple re - uses / misuses of the same nozzle. Preferably, the whole device is made of titanium. This is because of the acoustic properties that titanium imparts to the structure of this device. Figure 4 is a block diagram showing the operation of the device of the present invention. According to a non - limiting exemplary embodiment, treatment procedures such as PIPAC are repeated 6 to 8 times or more every 6 weeks for palliative patients. Since the prior - art mechanisms require a huge setup, they cannot be set up in small hospitals. Therefore, it is impossible for patients to receive better treatment due to availability and economic problems. However, the device of the present invention is independent and portable, so it is convenient to use. Therefore, this device can be used even in small hospitals, thereby overcoming the availability and price problems of the prior art. In addition, the inventors of the present invention observed that in the prior art mechanism, undiluted and non-aerosolized droplets of chemotherapy were delivered as they were. In contrast, in the device of the present invention, aerosolized drugs are administered from the first administration. Further, the inventors of the present invention observed that in the prior art mechanism, the average particle size delivered to the abdomen was in the micron (micrometer) size range by pressure-based aerosolization technology. In contrast, the average particle size delivered to the abdomen using the NAC (nanoaerosolized chemotherapy) technology of the device of the present invention is in the nanometer size range. Therefore, the penetration depth into the tissue becomes deeper, the drug concentration in the tissue becomes better, and the drug distribution on the tissue becomes better. Typically, when using the prior art mechanism, the volume of particles ≥ 3 μm is 97.5%, and the volume of particles ≤ 3 μm is 2.5%. In contrast, when using the device of the present invention, the volume of particles ≤ 150 nm is 95%, and the volume of particles ≥ 150 nm and ≤ 500 nm is 5%. All particles are in the nanometer region. The inventors further observed that on the peritoneal surface facing the prior art aerosolization device, larger droplets mainly deposit by impaction and gravitational sedimentation, resulting in poor drug distribution in the abdominal cavity. In contrast, when using the device of the present invention, since the particle size is in the nanometer size range of 46 nm to 176 nm, it can be uniformly dispersed in the abdominal cavity and can spread to inaccessible regions, thus improving bioavailability and treatment outcomes. Figure 5 shows that the smaller the particle size from 46 nm to 176 nm, the more the absorption of the drug in the tissue is promoted. Figure 6 shows that due to the decrease in the drug particle size, the drug penetration depth into the tissue increased up to 800 μm. Furthermore, the following was observed by using the device of the present invention. - Since the nozzle can be operated, a uniform drug distribution in the abdominal cavity is obtained, and the drug concentration in the tissue is increased, thus improving the bioavailability of the drug. - Since a third-party pressure injector for performing the procedure is not required, it can be carried out in small-scale hospital facilities, enhancing availability / accessibility to all necessary patients. - The particle size bandwidth is narrow. It should be understood that any drug can be used in connection with this device, even if this specification is written in connection with chemotherapy. The technical advancement of the present invention lies in providing a device for ultrasonic atomization of drugs for IP treatment. This drug delivery has a much tighter droplet size distribution than pressurized atomization of the prior art. Here, the drug atomized under the influence of ultrasonic waves has a particle size in the nanometer range. Using the device of the present invention results in a greater penetration depth and better drug absorption. The flow of the drug using the device of the present invention is by gravity feed. For this reason, it is only generally seen in large hospitals, and the expensive, bulky, and non-portable pressure injector systems usually required in prior art mechanisms are not necessary. Furthermore, since the bandwidth of the nanoparticle size is narrow, the drug distribution using the device of the present invention deposits uniformly throughout the peritoneal cavity. This detailed description discloses specific specific embodiments for illustrative purposes, but various changes that do not constitute a departure from the spirit and scope of the present invention as defined in the following claims will be apparent to those skilled in the art, and it should be clearly understood that the foregoing description is to be construed merely as an illustration of the present invention and not as a limitation.

Claims

1. 1. A device for delivering an aerosolized medication to a part of the body, comprising: a nozzle (100) including a body member (107) connected to an elongate shaft (108); o having one or more piezoelectric transducers (104, 106) mounted between a pair of conductive electrode discs (103, 105), said piezoelectric transducers (104, 106) configured to create capillary waves in a liquid film resulting in atomization of the medicament during passage through said nozzle (100); o having an opening (101) at the operable proximal end of said nozzle (100) through which a tube (112) is connected, said opening (101) communicating with a passageway (300) in said elongate shaft (108) configured to pass through said piezoelectric transducers (104, 106) and said conductive electrode discs (103, 105) to allow passage of a medicament received through said tube (112); and - the elongate shaft (108) supports a body member (107) at its operable proximal end and has an opening (109) at its operable distal end, through which the medicament received through the tube (112) and passing through the passageway (300) is expelled.

2. 2. The device according to claim 1, wherein the piezoelectric vibrator (104, 106) is a disc-shaped piezoelectric vibrator (104, 106).

3. 2. The apparatus of claim 1, wherein the conical surface (110) of the nozzle is a sandblasted conical surface (110) which roughens the surface and reduces the cohesive forces between liquid atoms, resulting in fine atomization even at high flow rates.

4. 2. The apparatus of claim 1, wherein the body member (107) is a cylindrical body member (107) having a flat, operable upper surface configured to support the nozzle (100).

5. 2. The apparatus of claim 1, wherein an operational portion of the nozzle (100) includes a fastening mechanism (102) for retaining the piezoelectric transducer (104, 106) from the operational portion.

6. 2. The apparatus according to claim 1, further comprising a body member (107) provided at an operating bottom of the nozzle (100) and holding the piezoelectric vibrators (104, 106) from the operating bottom.

7. 2. The device of claim 1, wherein the tube (112) is connected to the nozzle (100) through the opening (101) by a Luer connector.

8. 2. The apparatus of claim 1, wherein the tube (112) is a gravity-fed tube (112) in which the drug flows through the tube under the force of gravity.

9. 2. The apparatus of claim 1, wherein a cable (113) applies an electrical potential to the piezoelectric transducers (104, 106).

10. 2. The apparatus of claim 1, wherein the cylindrical body member (107) extends away from the discs (103, 105) to define an elongated shaft (108) having a diameter substantially smaller than a diameter of the cylindrical body member (107).

11. 2. The apparatus of claim 1, further comprising a conical surface (110) adjacent the opening (109), the conical surface (110) tapering to be narrowest adjacent the opening (109) in the elongate shaft (108).

12. 2. The device of claim 1, further comprising a step (302) disposed at the operable distal end of the elongate shaft (108) adjacent the opening (109).

13. 2. The apparatus according to claim 1, wherein the operating frequency of the apparatus is in the range of 20 to 80 KHz.

Images