A DEVICE FOR COLLECTION AND SCAVENGING OF BIOLOGICAL SAMPLES, AND DRUG DELIVERY FOR HOLLOW ORGANS

Abstract

The present invention discloses a device for the collection and scavenging of biological samples, and drug delivery for upper and lower respiratory tracts and hollow organs. The device comprises a distal balloon assembly (101) comprising distal carrier disc (101a) and a distal balloon (102), a proximal balloon catheter assembly (103) comprising proximal carrier disc (103a) and a proximal balloon (104), an inflation tube (108), a double lumen catheter (105) with an outer tube (105a) and an inner tube (105b), an agitator (106) working by methods such as ultrasonication, vibration, rotation, to-and-fro movements, pulsations etc, a flexible rod (107) to mount the agitator (106). Thus, the invention provides the device or a catheter with balloons to isolate pathogens or viruses from nasal cavity, nasopharynx, or relevant segment of hollow organs, with or without the use of water or similar liquids.

Claims

1. A device for collection of one or more biological samples, scavenging and for drug delivery in the upper respiratory tract, the device (100) comprising: a) a distal balloon assembly (101) comprising a distal carrier disc (101a) and a distal balloon (102) mounted watertight by the distal balloon (102) at the lower end of nasopharynx region above the soft palate; b) a proximal balloon assembly or nose plug assembly (103) comprising proximal carrier disc (103a), a proximal balloon (104) and a balloon inflation tube (108) mounted watertight by the proximal balloon (104) inside the nostril; c) a double lumen catheter (105) connected to the distal balloon (102) in one of the nostrils and inflates the distal balloon (102) by injecting air or water; and d) an agitator (106) mounted on the flexible rod (107) used for agitation of the liquid into the confined cavity.

2. The device as claimed in claim 1, wherein said distal balloon assembly (101) is inserted through the mouth accessing the nasopharynx region of the user.

3. The device as claimed in claim 1, wherein double lumen catheter (105) further comprises an outer tube (105a) and an inner tube (105b).

4. The device as claimed in claim 1, wherein said distal balloon (102) is inflated by water or air and the proximal balloon (104) is inflated through one or more balloon inflation tubes (108a and 108b).

5. The device as claimed in claim 1, wherein said distal balloon assembly (101) is supported laterally at the soft palette with one or more attachments.

6. The device as claimed in claim 1, wherein device (101-A) for insertion through the mouth further comprises: a. a flexible shaft assembly (109) comprising agitator shaft (109a) and an agitator tube (109b), b. an excitor unit (110) mounted on the flexible shaft assembly (109), c. a mounting platform (111) comprising a raising platform and a lever system (112) to raise the distal balloon assembly (101) after insertion; and d. a tray (113) placed below the nasopharynx region to collect the aspirate fluid.

7. The device as claimed in claim 6, wherein said device (101-A) comprising distal balloon (102) is inflated to achieve leak tight joint with the nasopharynx wall.

8. The device as claimed in claim 6, wherein said device (101-A) comprising excitor unit (110) is extendable up to top portion of the nasopharynx region and aids in physical agitation.

9. The device as claimed in claim 6, wherein said device (101-A) comprising mounting platform (111) is mounted between upper and lower set of teeth inside the mouth.

10. The device as claimed in claim 6, wherein said device (101-A) comprising base plate (111) and lever (112) are inserted through the mouth and raised towards lower end of the nasopharynx using levers (112).

11. The device as claimed in claim 1, wherein device (200) further comprises a central open passageway tube (201) which maintains the functionality of the organs and collects one or more biological samples, scavenges and aids in drug delivery to hollow organs in the lower respiratory tract.

Description

BRIEF DESCRIPTION OF THE DRAWINGS

[0017] The foregoing and other features of embodiments will become more apparent from the following detailed description of embodiments when read in conjunction with the accompanying drawings. In the drawings, like reference numerals refer to like elements.

[0018] FIG. 1 illustrates a device for the collection of biological samples, scavenging and drug delivery for upper respiratory system according to an embodiment of the invention.

[0019] FIG. 1A illustrates a modification of the device for the collection of biological samples, scavenging and drug delivery for upper respiratory system according to another embodiment of the invention.

[0020] FIG. 2 illustrates a device for the collection of biological samples, scavenging and drug delivery for lower respiratory system and other hollow organs according to another embodiment of the invention.

DETAILED DESCRIPTION OF THE INVENTION

[0021] Reference will now be made in detail to the description of the present subject matter, one or more examples of which are shown in figures. Each example is provided to explain the subject matter and not a limitation. Various changes and modifications obvious to one skilled in the art to which the invention pertains are deemed to be within the spirit, scope, and contemplation of the invention.

[0022] In order to more clearly and concisely describe and point out the subject matter of the claimed invention, the following definitions are provided for specific terms, which are used in the following written description.

[0023] The term Swab refers to a small piece of soft, absorbent material, such as gauze usually attached to a stick or a wire to aid access, to apply medicine, or take samples of body fluids, as the context requires.

[0024] The present invention discloses a single or combination of devices that are useful in collecting and scavenging biological samples and foreign materials from both lower and upper respiratory tracts. The device is also useful in drug delivery for hollow organs.

[0025] FIG. 1 illustrates a device (100) for the collection of biological samples, scavenging and drug delivery for upper respiratory system according to an embodiment of the invention. The device (100) comprises a distal balloon assembly (101), which comprises a distal carrier disc (101a), a distal balloon (102), a proximal balloon assembly (103) or a nose plug assembly which comprises a proximal carrier disc (103a), a proximal balloon (104) with a balloon inflation tube (108), a double lumen catheter (105) with an outer tube (105a) and inner tube (105b) for inflation of the distal balloon (102), an agitator (106) and a flexible rod (107).

[0026] The distal balloon assembly (101) is mounted at the lower end of the nasopharynx region near the soft palate. The proximal balloon assembly (103) is mounted inside the nostril. Both the assemblies are mounted watertight by use of the balloons (102 and 104). The distal balloon (102) is inflated by water or air injected through the inner tube (105b) of the double lumen catheter (105). The proximal balloon (104) is inflated through the balloon inflation tubes (108) attached to the proximal balloon assembly (103). The agitator (106) is mounted on the flexible rod (107) passing through the nose plug. The assemblies are mounted in both nostrils, with the double lumen catheter (105) connected to distal balloon assembly (101) in one nostril.

[0027] The sample collection and scavenging procedure comprise the steps of mounting the distal balloon assembly (101) and inflating the distal balloon (102) once the proximal balloon assembly (103) is in place with the outer tube (105a) of the double lumen catheter (105), used for infusing and aspirating the liquid within the upper respiratory tract, followed by inflating the proximal balloon (104), infusing the collection liquid into the confined cavity, agitating the liquid adequately using the agitator (106), aspirating the liquid, transferring it to the collection vial for testing, deflating the proximal balloon (104) and distal balloon (102) and withdrawing the double lumen catheter (105) and distal balloon assembly (101) and proximal balloon assembly (103) altogether.

[0028] The agitator (106) is flexible and extendable up to nasopharynx and loaded into both the nostril and it comprises an attachment, which mainly aids in physical agitation or scrubbing by to-and-fro movement or rotation or ultrasonication or vibration, pulsation etc. The tool further aids in local heating by conduction or convection or radiation and is capable of applying local medication, provided with a provision for injection and sucking of air instead of water through the agitator (106) if situation warrants.

[0029] According to another embodiment of the invention, FIG. 1A illustrates a modification of the device for the collection of biological samples, scavenging and drug delivery for upper respiratory system. The device (101-A) comprises the distal balloon assembly (101), which is inserted through the mouth using a mounting platform (111) for proper positioning of the distal plug (101a) which in turn carries the inflated distal balloon (102). The distal balloon assembly (101) comprises a main collection fluid injection and extraction tube (105), a balloon inflation tube (105a), a flexible shaft assembly (109a and 109b) on which is mounted an agitator or exciter unit (110), the mounting platform (111) comprising a lever system (112) for raising the distal balloon assembly (101) once inserted. The distal balloon assembly (101) comprises a tray (113) made up of any soft material, which is advanced below nasopharynx region after the distal balloon assembly (101) is locked in position.

[0030] The proximal plug (103) is mounted on the nose according to an embodiment of the invention. The distal plug assembly (101) comprising the plug (101a), the balloon (102), the agitator shaft and tubes (109a, 109b), the excitor unit (110), the balloon inflation tube (105a) and the aspirate tube (105). The mounting and raising platform (111) comprising base plate and lever (112). The base plate and the lever (112) are inserted through the mouth, placed in a position for raising towards the lower end of nasopharynx using the levers (112), and on reaching the suitable elevation, the balloons (102) are inflated to achieve a leak tight joint with nasopharynx wall. The mounting platform (111) is suitably placed and fixed on and between the upper and lower set of teeth for freeing the hand of the operator. The tray (113) is then advanced and placed in the suitable position to collect or soak any leakage of the aspirate fluid. The non-return valves are fitted on the tubes (105a and 105) for the aspirate extraction and on the tubes (105a and 105) for the inflation of the balloon. Thus, with this assembly, main aspirate extraction and agitator operation are achieved either through the nasal or the oral cavity, preferably through the oral cavity. After positioning the distal balloon (102), all other components are mounted and function like the embodiment as described in device (100).

[0031] The sample collection and scavenging procedure comprises the steps of mounting the distal balloon assembly (101) and inflating the distal balloon (102) once the proximal balloon assembly (103) is held in the initial position. The proximal balloon (104) is inflated along with inserting the distal balloon (101) and placing the assembly into pharynx through the mouth. The balloon assembly (101) is placed at the bottom of the nasopharynx along with inflating the distal balloon (102), agitating the liquid adequately using the agitator (106). The liquid is aspirated and transferred into the collection vial for testing. The proximal balloon (104) and the distal balloon (102) are deflated. The distal balloon (102), mounting platform (111) assembly and the proximal balloon assembly (103) are withdrawn.

[0032] The exciter unit (110) is flexible and extendable up to the top position of nasopharynx and loaded into both the nostrils. The exciter unit (110) comprises an attachment, which mainly aids in physical agitation or scrubbing by to-and-fro movement or rotation or ultrasonication or vibration, pulsation etc. The tool further aids in local heating by conduction or convection or radiation and is capable of applying local medication, provided with a provision for injection and sucking of air instead of water through the exciter unit (110) if situation warrants. The agitator (106) which is mounted on the proximal balloon is available for agitation inside both the nostrils. The injection and extraction of aspirate is done either from mouth or nose depending on the case.

[0033] Having generally described this invention, a further understanding can be obtained by reference to certain specific examples, which are provided herein for purposes of illustration only and are not intended to be limiting unless otherwise specified.

Example 1: Collection and Scavenging Device for Pathogens and Foreign Materials in the Upper Respiratory Tract

[0034] The sample collection and scavenging procedure comprises the steps of removing the device (100) from the pouch, mounting the proximal balloon assembly (103) in the nostrils and inflating the proximal balloons (104) once the distal balloon assembly (101) and the double lumen catheter (105) are placed in maximum withdrawn condition within the upper respiratory tract, advancing the distal balloon assembly (101) and the double lumen catheter (105) till the distal balloon (102) reaches the nasopharynx bottom and locking the position, inflate the distal balloon (102) till it snugly fits in the pharynx opening, tilting the subject's head backwards slightly to give nasal passage a backward downward tilt, introducing the aspirate through the outer tube (105a) of the double lumen catheter (105) through one of the nostrils to fill the nasal passages, subsequently check the leak tightness of the distal balloon (102) at the nasopharynx, followed by agitating the aspirate inside the nasal passages using the agitator (106), aspirating the sample solution after reasonable time by tilting the head forward, transferring the sample solution into the collection vial, deflating the distal balloon (102) and withdrawing the distal balloon assembly (101) and the double lumen catheter (105), deflating the nostril sealing proximal balloons (104) and finally withdrawing the proximal balloon assembly (103). The nasal cavity is cleaned by blowing the nose if required once the sample is collected and the device is removed.

Example 2: Collection and Scavenging Device for Pathogens and Foreign Materials in the Lower Respiratory Tract and Other Hollow Organs

[0035] According to yet another embodiment of the invention, the device is used in the trachea and bronchi where the functionality of the organs is maintained by a central open passageway tube. The device is used in hollow organs such as the intestine, esophagus, etc. FIG. 2 illustrates a device (200) for the collection of biological samples, scavenging and drug delivery for lower respiratory tract and other hollow organs. The device (200) comprises the distal balloon assembly (101), distal balloons (102), a balloon inflation tubes (108a and 108b), a central open passageway tube (201), a proximal balloon catheter assembly (103), the proximal balloons (104), an agitator (106) with or without a motor, providing the functionality as in device (100), and catheter (105) to aspirate or infuse.

[0036] The sample collection and scavenging procedure comprise the steps of removing the device (200) from the pouch, setting the position of the proximal balloon (104) as per the requirement of the patient, introducing the collection device into the hollow organ such as the trachea, advancing the device till the distal balloon (102) reaches an appropriate position in the trachea, inflating the distal balloon (102) by means of the balloon inflation tube (108a), till the inflated balloon snugly fits in the trachea, followed by inflating the proximal balloon (104) by means of the balloon inflation tube (108b), subsequently introducing the aspirate by means of the catheter (105) and agitating using the agitator (106), aspirating the sample solution after a reasonable time, transferring the sample solution into the collection vial for testing, finally deflating the balloons (102 and 104) before withdrawing the device (200) assembly.

[0037] The advantages of using the device and technique are improved pathogen or virus collection from upper and lower respiratory passages for fast, precise and reliable results. It eliminates errors or false-negative results particularly in respiratory infections including COVID-19 testing. Moreover, the localized approach of scavenging most of the viruses from respiratory passages, that are the main areas where the viruses are primarily located in early stage prevents the development of the disease, as well as its manifestation into severe disease. Thus, the device of the present invention further aids in reducing the spread of infection to potential contacts. Additionally, reducing the community spread from asymptomatic carriers and reducing the severity of the condition in a significant number of patients in the early stages of the disease, which further reduces the anticipated load on the healthcare system and associated resources.

[0038] Thus, the present invention provides a device or a catheter with balloons to isolate pathogens or virus from the nasal cavity, nasopharynx, or relevant segment of hollow organs. Further, the use of sample collection liquid that comes in contact with all relevant surfaces to collect the sample proves to be an error-free approach. Moreover, the sample collection efficiency is improved by the agitation using various techniques such as ultrasonication, vibration, to-and-fro movement of the liquid apart and also other physical and chemical techniques which result in increasing the secretion of mucus. Thereby, ensuring the release and collection of the viruses or other pathogens within the cells and or in the extracellular space. The technique is useful in reducing or removal of the virus or pathogen. The device and method are thus useful for sample collection and scavenging the viral or pathogens from the nasal cavity as well as for drug delivery inside other hollow organs.

TABLE-US-00001 Reference numbers: Components Reference Numbers Biological sample collecting and 100 scavenging device Distal Balloon Assembly 101 Distal Carrier Disc or Distal Plug 101a Distal Balloon 102 Proximal Balloon Assembly or 103 Nose Plug Assembly Proximal Carrier Disc 103a Proximal Balloon 104 Double Lumen Catheter or 105 Aspirate Tube Inner Tube 105a Outer Tube 105b Agitator 106 Flexible Rod 107 Balloon Inflation Tube 108 Balloon Inflation Tube 108a Balloon Inflation Tube 108b Flexible Shaft Assembly 109a and 109b Excitor Unit 110 Mounting Platform 111 Lever System 112 Tray 113