Device for delivering an aerosolized medicament into a portion of a body

Abstract

A device for delivering an atomized medicament into a portion of a body includes a nozzle (100) comprising a head extending distally to an elongated shaft (108), the head including a piezoelectric transducer (104, 106) mounted between electrically conductive electrode disks (103, 105), the piezoelectric transducer (104, 106) generating capillary waves in a liquid film to cause atomization of a medicament as the medicament passes through the nozzle (100), an aperture (101) in the nozzle (100) through which a tube (112) is connected, the aperture (101) followed by a passage (300) disposed in the elongated shaft (108) and passing through the piezoelectric transducer (104, 106) and the electrically conductive electrode disks (103, 105) to allow passage of a medicament received through the tube (112), and the elongated shaft (108) supporting a body member (107) at an operative proximal end thereof and having an opening (109) through which the medicament is dispensed.

Description

Technical fields:

[0001] This invention relates to the field of biomedical engineering.

[0002] In particular, the present invention relates to a device for delivering atomized medication into a part of the body. Background Technology

[0003] Chemotherapy uses drugs to destroy cancer cells. It typically works by stopping cancer cells from growing, dividing, and producing more cells. Because cancer cells usually grow and divide faster than normal cells, chemotherapy is more effective against them. In chemotherapy, many drugs need to be injected directly into a vein; this is called intravenous (IV) therapy.

[0004] Compared to intravenous (IV) therapy, intraperitoneal (IP) administration results in several times higher intraperitoneal drug concentrations.

[0005] Increasing clinical research evidence now suggests a survival advantage of intraperitoneal (IP) chemotherapy in various tumor types, including ovarian, thoracic, gastric, and colorectal cancers. The efficacy of IP chemotherapy is limited by poor intraperitoneal distribution and poor tissue penetration.

[0006] Therefore, a new method is needed to administer intraperitoneal chemotherapy drugs into the abdominal cavity.

[0007] The existing technique known as pressurized intraperitoneal aerosol chemotherapy (PIPAC) administers chemotherapy drugs via a laparoscopic approach using two balloon cannulas in an operating room equipped with laminar flow. In the first step, a normothermic carbon dioxide peritoneum is established at a pressure of 12 mmHg. In the second step, a cytotoxic solution (approximately 10% of the normal systemic dose) is nebulized into the peritoneal cavity using a pressure injector and maintained for 30 minutes. In the third step, the aerosol is then removed via a closed aspiration system.

[0008] However, there is a need to move away from existing technologies that deliver aerosols under pressure. Existing mechanisms rely on third-party pressure delivery, which is inefficient. These third-party pressure delivery mechanisms are syringes that generate pressure to supply the medication into the nozzles of existing technologies. These pressure syringes are bulky devices, typically available in larger hospitals, and are primarily used for transillumination injections in patients in CT, MRI, and CATHLAB departments.

[0009] This limits the use of this treatment in small hospitals that do not have pressure injectors.

[0010] A device, mechanism, equipment, and / or system that does not rely on pressure and / or any pressure injector and / or any third-party delivery equipment is required.

[0011] Purpose of the invention

[0012] One object of the present invention is to provide a novel method for administering intraperitoneal chemotherapy drugs into the abdominal cavity.

[0013] Another object of the present invention is to provide an apparatus for delivering chemotherapy drugs in an atomized form to the abdomen of a palliative patient, wherein the drug delivery has an average nanometer size or smaller.

[0014] Another object of the present invention is to provide an apparatus for delivering chemotherapy drugs in the form of an aerosol under ultrasound.

[0015] Another object of the present invention is to provide an easier delivery mechanism for delivering chemotherapy drugs to the abdomen of a patient receiving palliative treatment.

[0016] Another object of the present invention is to provide a device that ensures the safety of OT / OR personnel while delivering nebulized chemotherapy drugs to the abdomen.

[0017] Another object of the present invention is to provide the possibility of safe mobility of the drug delivery nozzle while delivering atomized chemotherapy drugs to better reach the peritoneal cavity.

[0018] Another object of the present invention is to provide a device that does not rely on pressure and / or any pressure injector and / or any third-party equipment for delivery.

[0019] Another object of the present invention is to provide a device that is easy to use in small hospitals. Summary of the Invention

[0020] According to the present invention, an apparatus for delivering atomized medication into a part of the body is provided, the apparatus comprising:

[0021] A nozzle, comprising a head extending distally to an elongated shaft, the head including:

[0022] One or more piezoelectric transducers are mounted between a pair of conductive electrode disks and are configured to generate capillary waves in a liquid film, thereby causing drug atomization as the drug passes through the nozzle;

[0023] An orifice at the proximal end of the nozzle, through which a tube is connected, the orifice following a channel disposed in the elongated shaft and passing through the piezoelectric transducer and the conductive electrode disk, to allow drug received through the tube to pass through; and

[0024] The elongated shaft supports the main body member at its proximal operating end and has an opening at its distal operating end, through which the drug, received by the tube and passing through the channel, is dispensed. In at least one embodiment, the piezoelectric transducer is a disc piezoelectric transducer.

[0025] In at least one embodiment, the main body component is a cylindrical main body component, the flat operating top surface of which is configured to support the nozzle.

[0026] In at least one embodiment, a fastening mechanism is provided at the operating top of the nozzle to hold the piezoelectric transducer from the operating top of the nozzle.

[0027] In at least one embodiment, a main body member is provided at the operating bottom of the nozzle to hold the piezoelectric transducer from the operating bottom of the nozzle.

[0028] In at least one embodiment, the tube is connected to the nozzle via the orifice by means of a Luer connector.

[0029] In at least one embodiment, the tube is a gravity-fed feed tube.

[0030] In at least one embodiment, the cable applies a potential to the piezoelectric transducer.

[0031] In at least one embodiment, the cylindrical body member extends away from the disk to form an elongated shaft with a diameter substantially smaller than that of the cylindrical body member.

[0032] In at least one embodiment, a tapered surface is provided adjacent to the opening, the tapered surface gradually tapering so that it is narrowest near the opening of the elongated shaft.

[0033] In at least one embodiment, a step is provided at the operative distal end of the elongated shaft adjacent to the opening.

[0034] In at least one embodiment, a controller is provided to control the vibration frequency of the piezoelectric transducer, which then atomizes the drug from its liquid form into a nanoparticle mist, which is then dispensed through the opening.

[0035] In at least one embodiment, the operating frequency of the device is in the range of 20 to 80 kHz. Attached Figure Description

[0036] The invention will now be described in conjunction with the accompanying drawings, in which:

[0037] Figure 1 This is an isometric view of the nozzle of the device of the present invention;

[0038] Figure 2 yes Figure 1 Top view of the nozzle shown;

[0039] Figure 3 This is a cross-sectional view of a nozzle constructed according to the present invention, which shows the main components of the nozzle;

[0040] Figure 4 A block diagram of the device of the present invention is shown;

[0041] Figure 5 This demonstrates that smaller particle sizes in the 46 nm to 176 nm size range enhance drug absorption in tissues; and

[0042] Figure 6 This demonstrates that due to the smaller drug particle size, the drug's penetration depth in tissues increases to 800 μm. Detailed Implementation

[0043] According to the present invention, an apparatus is provided for delivering atomized drugs into a part of the body.

[0044] The device of the present invention facilitates a novel way of administering intraperitoneal (IP) chemotherapy drugs into the typical peritoneal cavity in the form of an aerosol.

[0045] Figure 1 This is an isometric view of the nozzle.

[0046] Figure 2 yes Figure 1 The nozzle shown is shown in top view.

[0047] Figure 3 This is a cross-sectional view of a nozzle constructed according to the present invention, showing the main components of the nozzle.

[0048] In at least one embodiment, the device includes a nozzle (100). The nozzle (100) includes one or more piezoelectric transducers (104, 106) that generate capillary waves in a liquid film, thereby causing the drug to be atomized as it passes through the nozzle (100). Typically, the nozzle (100) includes one or more disc-shaped piezoelectric transducers (104, 106) mounted between a pair of conductive electrode discs (103, 105). A potential is applied via an RF coaxial cable (113).

[0049] Refer to the attached diagram, especially Figure 1A nozzle 100 according to the invention is shown. The nozzle (100) forming the head includes disc-shaped piezoelectric transducers (104, 106) mounted between a pair of conductive electrode discs (103, 105) and a cylindrical body member (107) (as a support member) on a flat surface. An electric potential is applied via an RF coaxial cable (113). The cylindrical body member (107) and a fastening mechanism (102) are holders (top and bottom) of the piezoelectric transducers (104, 106). A hole (101) is provided on the rear body member (111) of the nozzle (100), through which a tube (112) (which may be of group IV) is connected by means of a Luer connector. The hole (101) has a channel (300) through which the drug flows. The cylindrical body member (107) extends away from these discs (103, 105) to form an elongated shaft (108) whose diameter is substantially smaller than that of the cylindrical body member (107). An opening (109) is located at the distal operating end of the nozzle (100), i.e., the free end of the elongated shaft (108) (nozzle rod); the drug is dispensed through this opening. Adjacent to the opening (109) is a tapered surface (110); the tapered surface (110) tapers gradually, becoming narrowest near the opening (109) adjacent to the elongated shaft (108). For flow rate and nozzle interaction, the tapered surface (110) of the nozzle is sandblasted to reduce the cohesive forces between liquid atoms by roughening the surface, resulting in fine atomization even at higher flow rates.

[0050] Reference Figure 3 The channel (300) within the elongated shaft (108) allows the drug to flow before being dispensed through the opening (109). Reference numeral 301 indicates a bend in the nozzle (100) to accommodate the diameter variation from the cylindrical body member (107) to the elongated shaft (108) to which it is connected. A step (302) is provided at the distal end.

[0051] In at least one embodiment, the device includes a controller for controlling the vibration frequency of a piezoelectric transducer (104), which atomizes the diluted drug from its liquid form into a nanoparticle mist, which can then be sprayed / delivered into the abdominal cavity through a nozzle (100) of the present invention. The nozzle is custom-designed or specially made to be compatible with the controller and specifically designed for the intended application.

[0052] The particle size produced by the device of the present invention depends on the vibration frequency, surface tension, and viscosity of the liquid. Particle size is inversely proportional to frequency; therefore, increasing the frequency can reduce particle size. In this device, the liquid is not forced through a small orifice but flows through a large channel in which ultrasonic waves generate an aerosol.

[0053] In at least one embodiment, the nozzle (100) is connected to the controller unit via a coaxial RF cable (113) through which an electric potential is applied. The tube (110) is connected via a Luer connector attached to the nozzle (100). A cylindrical body member (107) and a fastening mechanism (102) depict the holding body of the piezoelectric transducer (104, 106). A hole (101) is present on the rear body member (111) of the nozzle (100), through which the tube (112) is connected by means of a Luer connector.

[0054] The nozzle rod (108) includes a tapered surface (110) at its distal operating end, such that the narrowest portion of the nozzle rod (108) is adjacent to the opening (109). Reference numeral 300 indicates a channel for drug flow.

[0055] In at least one embodiment, the identification of the nozzle (100) is initiated by actuation of the controller. This stage checks the status of the nozzle, i.e., whether it is a used nozzle or a new nozzle (100). Upon reconfirmation of the identification stage and pressing a key, the controller begins to supply power to the nozzle (100). The clamp valve present in the tube (112) is opened, and the drug begins to be atomized from the tip of the nozzle (100).

[0056] Typically, the operating frequency of this device is in the range of 20-80KHz.

[0057] In at least one embodiment, using the device of the present invention, the drug flows through the tube (112) under the influence of gravity; therefore, no pressure injector or any third-party equipment is required.

[0058] The device of this invention is configured to generate and deliver an aerosol under ultrasonic waves. This is more efficient and easier to set up and deliver compared to existing technologies. The device does not rely on a third-party pressure injector. Since surgery is repetitive in palliative care, this device is particularly advantageous because it is independently manufactured and does not depend on a third party, thus reducing costs.

[0059] Preferably, RFID technology is used to prevent the repeated reuse / misuse of the same nozzle.

[0060] Preferably, the entire device is made of titanium, because titanium adds acoustic properties to the structure of the device.

[0061] Figure 4 A block diagram of the device of the present invention is shown.

[0062] According to a non-limiting exemplary embodiment, for patients receiving palliative care, treatment procedures such as PIPAC are repeated every 6 weeks and more than 6-8 times. Existing institutions require large facilities; therefore, they cannot be established in small hospitals. This prevents patients from receiving better treatment due to availability and affordability issues.

[0063] However, the device of the present invention is independent and portable; therefore, it is easy to use. Thus, the device can be used even in small hospitals; thus, it overcomes the availability and affordability problems of the prior art.

[0064] The inventors also observed that prior art devices deliver very few un-nebulized droplets of diluted chemotherapy drugs at the beginning, which is entirely undesirable. In contrast, the device of the present invention delivers nebulized drugs precisely from the first delivery moment; there is no lag in delivering drugs of the correct particle size.

[0065] The inventors also observed that in prior art devices, due to pressure-based aerosol technology, the average particle size delivered in the abdomen is μm (micrometer). In contrast, the device of this invention, using NAC (nano-nebulized chemotherapy) technology, delivers an average particle size of nanometers in the abdomen. This ensures greater penetration depth in tissue, better drug concentration in tissue, and better drug distribution in tissue.

[0066] Typically, using existing devices, the volume of particles ≥3 μm is 97.5% and the volume of particles ≤3 μm is 2.5%; while using the device of the present invention, the volume of particles ≤150 nm is 95% and the volume of particles ≥150 nm but ≤500 nm is 5%. All particles are in the nanometer range.

[0067] The inventors further observed that larger droplets, through collision and gravitational settling, primarily deposit on the peritoneal surface of prior art nebulizers, resulting in poor drug distribution within the peritoneal cavity. In contrast, using the device of this invention, the particles are nanoscale, ranging from 46 nm to 176 nm; therefore, they can be uniformly dispersed within the peritoneal cavity, even reaching hard-to-reach areas; this improves bioavailability and enhances therapeutic efficacy.

[0068] Figure 5 Smaller particle sizes in the 46 nm to 176 nm size range are shown to enhance drug absorption in tissues.

[0069] Figure 6 This demonstrates that due to the smaller drug particle size, the drug's penetration depth in tissues increases to 800 μm.

[0070] It was further observed that, by using the device of the present invention:

[0071] - Due to the operability of the nozzle, the drug is distributed uniformly in the abdominal cavity and the drug concentration in the tissues is greater, thereby improving the bioavailability of the drug.

[0072] - No third-party pressure injector is needed to perform the surgery, thus enabling the procedure to be completed in small hospital facilities, thereby increasing availability / accessibility to every patient in need; and

[0073] - Tighter granular bandwidth.

[0074] Although this instruction manual may be written in relation to chemotherapy drugs, it should be understood that any drug may be used in conjunction with this device.

[0075] The technical advantage of this invention lies in providing a device that delivers ultrasonic nebulization of medication for IP treatment; this medication delivery has a denser droplet size distribution than prior art pressurized nebulization. Here, under the influence of ultrasound, the nebulized medication has a particle size in the nanometer range. Using the device of this invention results in greater penetration depth and therefore better drug absorption; thus, improved system effectiveness and better patient outcomes are ensured. The medication flow using the device of this invention is gravity-fed; this eliminates the need for expensive, bulky, and non-portable pressure injector systems typically found only in larger hospitals and usually required by prior art institutions. Furthermore, due to the narrow bandwidth of the nanoparticle size, using the device of this invention, the medication is deposited uniformly throughout the peritoneal cavity.

[0076] While certain specific embodiments have been disclosed in this detailed description for illustrative purposes, various modifications will be apparent to those skilled in the art. These modifications do not constitute a departure from the spirit and scope of the invention as defined in the appended claims, and it should be clearly understood that the foregoing description is to be interpreted as illustrative of the invention and not as a limitation thereof.

Claims

1. A device for delivering nebulized medication to a part of the body, the device comprising: A nozzle (100) includes a head that extends distally to an elongated shaft (108), the head comprising: One or more piezoelectric transducers (104, 106) are mounted between a pair of conductive electrode disks (103, 105) and the piezoelectric transducers (104, 106) are configured to generate capillary waves in the liquid film, thereby causing drug atomization as the drug passes through the nozzle (100); At the proximal end of the nozzle (100), a hole (101) is provided through which the tube (112) is connected. This hole (101) is followed by a channel (300) disposed within the elongated shaft (108) and passing through the piezoelectric transducer (104, 106) and the conductive electrode disks (103, 105) to allow the drug received through the tube (112) to pass through. The elongated shaft (108), which supports the main body member (107) at its proximal operating end and has an opening (109) at its distal operating end, through which the drug, received by the tube (112) and passing through the channel (300), is dispensed via the opening (109). The main body component (107) is a cylindrical main body component (107), and the flat operating top surface of the cylindrical main body component is configured to support the nozzle (100). The cylindrical main body component (107) extends away from the disks (103, 105) to form the elongated shaft (108), the diameter of which is smaller than the diameter of the cylindrical main body component (107). A tapered surface (110) is provided adjacent to the opening (109), the tapered surface (110) gradually tapers, making it narrowest near the opening (109) of the elongated shaft (108), and The conical surface (110) is a sandblasted conical surface (110) to reduce the cohesive force between liquid atoms by roughening the conical surface, thereby resulting in fine atomization even at high flow rates.

2. The apparatus according to claim 1, wherein, The piezoelectric transducers (104, 106) are disc piezoelectric transducers (104, 106).

3. The apparatus according to claim 1, wherein, A fastening mechanism (102) is provided at the operating top of the nozzle (100) to hold the piezoelectric transducer (104, 106) from the operating top of the nozzle.

4. The apparatus according to claim 1, wherein, The cylindrical main body component (107) is disposed at the operating bottom of the nozzle (100) to hold the piezoelectric transducer (104, 106) from the operating bottom of the nozzle.

5. The apparatus according to claim 1, wherein, The tube (112) is connected to the nozzle (100) via the hole (101) by means of a Luer connector.

6. The apparatus according to claim 1, wherein, The pipe (112) is a gravity-fed feed pipe (112).

7. The apparatus according to claim 1, wherein, The cable (113) applies a potential to the piezoelectric transducer (104, 106).

8. The apparatus according to claim 1, wherein, A step (302) is provided at the distal end of the operation of the elongated shaft (108) adjacent to the opening (109).

9. The apparatus according to claim 1, wherein, A controller is provided to control the vibration frequency of the piezoelectric transducer (104, 106), which then atomizes the drug from its liquid form into a nanoparticle mist, which is then dispensed through the opening (109).

10. The apparatus according to claim 1, wherein, The device operates at a frequency in the range of 20 to 80 kHz.

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