WO2012148473A1

WO2012148473A1 - Device and method of using the same for removing a flowable material contained within a vessel or cavity

Info

Publication number: WO2012148473A1
Application number: PCT/US2011/063645
Authority: WO
Inventors: Alan A. Waldman
Original assignee: Bryan Corporation
Priority date: 2011-04-26
Filing date: 2011-12-07
Publication date: 2012-11-01
Also published as: US20120273045A1

Abstract

A device for removing a flowable material such as a fluid contained within a vessel or cavity includes a nozzle body having an outlet, a first side portion impermeable to the flowable material located distally from the outlet, a second side portion permeable to the flowable material located proximate to the outlet, the second side portion being in fluid communication with the outlet through the nozzle body, and negative pressure generating means operatively associated with the outlet for generating negative pressure at the second side portion of the nozzle body sufficient to draw the flowable material into the nozzle body without damaging or substantially disrupting the vessel or cavity. Methods of using the same are also disclosed.

Description

DEVICE AND METHOD OF USING THE SAME FOR REMOVING

A FLOWABLE MATERIAL CONTAINED WITHIN A VESSEL OR CAVITY

Related Applications

This Application claims the benefit of priority from U.S. Provisional Patent Application Serial Number 61 /571 ,407, filed on June 27, 201 1 , and U.S. Provisional Patent Application Serial Number 61 /517,788, filed on April 26, 201 1 , the contents of which is incorporated herein by reference in the entirety.

Field of the Invention The present invention relates to devices, including medical and non-medical devices, and particularly to devices and methods of using the same for removing a flowable material such as a fluid from a site within the interior of a vessel or cavity in a safe and reliable manner. Background of the Invention

It is known in the art to draw or remove fluid from a site within an enclosed cavity or vessel. Among other applications, in the medical field, there is a need for removing fluids pursuant to a treatment regimen. For example, in a medical procedure, a surgical site is typically irrigated with a physiological aseptic solution and then suctioned with a vacuum tube to remove tissue and debris from the site, or to remove blood or vomit in an emergency situation. Suction may also be used to clear secretions from the oropharynx or trachea in patients unable to do so independently, for example, during such conditions as pneumonia or leakage within the chest cavity. Lower airway secretions that are not cleared may provide a medium for bacterial growth. The tissues around the fluids are sensitive to pressure and could be injured if excessive suction is applied. In addition to mucosal trauma, tracheal or endotracheal suctioning is often associated with other potentially harmful complications including hypoxemia, diminished cerebral blood flow, and vasovagal response causing arrhythmias and hypotension.

Prior art devices used for suctioning or aspirating fluids typically require specific implementation protocols to minimize any potentially life-threatening injuries or complications to surrounding mucosa, tissue and organs. Because very high levels of negative pressure are typically encountered during aspiration of fluids such as thick, tenacious secretions, particular care must be taken to avoid trauma especially in patients with clotting disorders. Current practice entails placing a suctioning device through a passageway (e.g., trachea) and applying negative pressure only when withdrawing the suctioning device away from the site of fluid removal (never during insertion). The negative pressure is initiated only upon withdrawing the device a significant distance (e.g., a full centimeter or so) from the site of fluid removal, and applied for a maximum period of about fifteen seconds to prevent injury. These restrictions limit the extent and the areas that can be effectively treated and the amount of material that can be removed from a given treatment area.

Current protocols advise that the diameter of the suctioning device be limited to less than one half of the internal diameter of the passageway to prevent occlusion of the passageway, and, in the case of tracheal suctioning, to avoid generating large negative intra-thoracic pressures. This limits the effective area of the open portion of the suctioning device. It would therefore be a significant advance in the art to provide devices and methods of using the same for removing a flowable material such as a fluid from a site within the interior of a vessel or cavity in a safe and reliable manner. There is a further need for such devices and methods of using the same that substantially overcome the limitations associated with prior art devices as described above.

Summary of the Invention

The present invention relates generally to devices and methods of using such devices for removing a flowable material such as a fluid contained within a vessel or cavity. Broadly, the device of the present invention includes a nozzle body configured for removing the flowable material from the vessel or cavity, and negative pressure generating means operatively associated with the nozzle body for generating negative pressure sufficient to draw the flowable material into the nozzle body in a manner that substantially minimizes damage or disruption of the vessel or cavity. The device of the present invention is designed to direct negative pressures associated with aspiration, removing or suctioning away from the distal end thereof, thereby significantly minimizing damage or disruption to immediate areas of the vessel or cavity (e.g., mucosal lining of tissue). As a result, the device of the present invention may be placed substantially closer to the surface of the vessel or cavity to enhance removal of the flowable material from the site. The present device enables greater levels of negative pressure to be achieved, while maintaining safety and reliability. In the present invention, devices, including medical and non-medical devices and kits comprising a plurality of such devices form part of the invention. During operation, the device of the present invention is used to draw or remove a flowable material such as a fluid at a site within the interior cavity or vessel, while avoiding or at least substantially minimizing any injury or disruption to the surrounding inside surfaces of the interior cavity or vessel due to high back pressure.

In one aspect of the present invention, there is provided a device for removing flowable material contained within a vessel or cavity, which comprises:

a nozzle body including:

an outlet;

a first side portion being impermeable to the flowable material and located distally from the outlet; and a second side portion being permeable to the flowable material and located proximate to the outlet, wherein the second side portion is in fluid communication therethrough with the outlet; and

negative pressure generating means operatively associated with the outlet for generating negative pressure at the second side portion thereof sufficient to draw the flowable material therein without damaging or substantially disrupting the vessel or cavity.

In another aspect of the present invention, there is provided a kit which comprises a plurality of the devices described above.

In another aspect of the present invention, there is provided a nozzle body of a device for removing flowable material contained within a vessel or cavity, said nozzle body comprising:

an outlet, said outlet being configured for fluid attachment with a negative pressure generating assembly;

a first side portion being impermeable to the flowable material and located distally from the outlet; and

a second side portion being permeable to the flowable material and located proximate to the outlet, wherein the second side portion is in fluid communication therethrough with the outlet.

In another aspect of the present invention, there is provided a kit which comprises a plurality of the nozzle bodies described above. In another aspect of the present invention, there is provided a method of removing a flowable material contained within a vessel or cavity, where the method comprises:

inserting the device described above into the vessel or cavity;

positioning the nozzle body so that the second side portion is proximate to the flowable material and remote from the surface of the vessel or cavity; and

generating negative pressure at the second side portion of the nozzle body sufficient to draw the fluid from the vessel or cavity into the nozzle body without damaging or substantially disrupting the vessel or cavity.

The present invention as herein described by making the second side portion permeable to the flowable material (and not the first portion) minimizes occlusion of the device that can occur when, as in prior art devices, the permeable portion is positioned proximate the vessel walls.

Brief Description of the Drawings

The following drawings in which like reference characters indicate like parts are illustrative of embodiments of the invention and are not intended to limit the invention as encompassed by the claims forming part of the application.

Figure 1 is a perspective view of a device for removing flowable material contained within a vessel or cavity incorporating a nozzle body specifically adapted for use in the human body in accordance with one embodiment of the present invention

Figure 2A is an elevational view of a nozzle body for facilitating transfer or removal of a flowable material from the interior of a cavity or vessel in accordance with one embodiment of the present invention;

Figure 2B is a bottom plan view of the nozzle body shown in Figure 2A in accordance with the present invention; Figure 2C is a top plan view of the nozzle body shown in Figure 2A in accordance with the present invention;

Figure 2D is an exploded assembly view of the nozzle body shown in Figure

2A in accordance with the present invention; Figure 2E is an elevational view of the nozzle body showing the angle of tilt (a) of the inlets relative to the longitudinal axis of the nozzle body in accordance with the present invention;

Figure 3 is a side elevation view of the nozzle body of the device disposed within a fluid-filled cavity in accordance with the present invention;

Figure 4A is a top plan view of a nozzle body of the device in accordance with a second embodiment of the present invention;

Figure 4B is a perspective view from the bottom of the nozzle body of Figure 4A in accordance with the present invention; Figure 4C is a side elevational view of the nozzle body of Figure 4A in accordance with the present invention;

Figure 5A is a top plan view of a nozzle body of the device in accordance with a third embodiment of the present invention;

Figure 5B is a perspective view from the bottom of the nozzle body of Figure 5A in accordance with the present invention; Figure 5C is a side elevational view of the nozzle body of Figure 5A in accordance with the present invention;

Figure 6A is a top plan view of a nozzle body of the device in accordance with a fourth embodiment of the present invention;

Figure 6B is a perspective view from the bottom of the nozzle body of Figure 6A in accordance with the present invention; Figure 6C is a side elevational view of the nozzle body of Figure 6A in accordance with the present invention;

Figure 7A is a top plan view of a nozzle body of the device in accordance with a fifth embodiment of the present invention;

Figure 7B is a perspective view from the bottom of the nozzle body of Figure 7A in accordance with the present invention;

Figure 7C is a side elevational view of the nozzle body of Figure 7A in accordance with the present invention;

Figure 8A is a top plan view of a nozzle body of the device in accordance with a sixth embodiment of the present invention; Figure 8B is a perspective view from the bottom of the nozzle body of Figure 8A in accordance with the present invention;

Figure 8C is a side elevational view of the nozzle body of Figure 8A in accordance with the present invention;

Figure 9A is a top plan view of a nozzle body of the device in accordance with a seventh embodiment of the present invention; Figure 9B is a perspective view from the bottom of the nozzle body of Figure

9A in accordance with the present invention;

Figure 9C is a side elevational view of the nozzle body of Figure 9A disposed within the interior of a cavity in accordance with the present invention;

Figure 10A is a top plan view of a nozzle body of the device in accordance with an eighth embodiment of the present invention;

Figure 10B is a perspective view from the bottom of the nozzle body of Figure 10A in accordance with the present invention;

Figure 10C is a side elevational view of the nozzle body of Figure 10A disposed within the interior of a cavity in accordance with the present invention; Figure 1 1A is a top plan view of a nozzle body of the device in accordance with a ninth embodiment of the present invention;

Figure 1 1 B is a perspective view from the bottom of the nozzle body of Figure 1 1 A in accordance with the present invention;

Figure 1 1 C is a side elevational view of the nozzle body of Figure 1 1A disposed within the interior of a cavity in accordance with the present invention; Figure 12A is a top plan view of a nozzle body of the device in accordance with a tenth embodiment of the present invention;

Figure 12B is a perspective view from the bottom of the nozzle body of Figure 12A in accordance with the present invention;

Figure 12C is a side elevational view of the nozzle body of Figure 12A disposed within the interior of a cavity in accordance with the present invention;

Figure 13A is a top plan view of a nozzle body of the device in accordance with an eleventh embodiment of the present invention;

Figure 13B is a perspective view from the bottom of the nozzle body of Figure 13A in accordance with the present invention; Figure 13C is a side elevational view of the nozzle body of Figure 13A disposed within the interior of a cavity in accordance with the present invention;

Figure 14A is a top plan view of a nozzle body of the device in accordance with a twelfth embodiment of the present invention;

Figure 14B is a perspective view from the bottom of the nozzle body of Figure 14A in accordance with the present invention; Figure 14C is a side elevational view of the nozzle body of Figure 14A disposed within the interior of a cavity in accordance with the present invention;

Figure 15A is a top plan view of a nozzle body of the device in accordance with a thirteenth embodiment of the present invention;

Figure 15B is a perspective view from the bottom of the nozzle body of Figure 15A in accordance with the present invention;

Figure 15C is a side elevational view of the nozzle body of Figure 15A disposed within the interior of a cavity in accordance with the present invention;

Figure 16A is a top plan view of a nozzle body of the device in accordance with a fourteenth embodiment of the present invention; Figure 16B is a perspective view from the bottom of the nozzle body of Figure 16A in accordance with the present invention;

Figure 16C is a side elevational view of the nozzle body of Figure 16A disposed within the interior of a cavity in accordance with the present invention;

Figure 17A is a top plan view of a nozzle body of the device in accordance with a fifteenth embodiment of the present invention; Figure 17B is a perspective view from the bottom of the nozzle body of Figure

17A in accordance with the present invention;

Figure 17C is a side elevational view of the nozzle body of Figure 17A disposed within the interior of a cavity in accordance with the present invention;

Figure 18A is a top plan view of a nozzle body of the device in accordance with a sixteenth embodiment of the present invention;

Figure 18B is a perspective view from the bottom of the nozzle body of Figure 18A in accordance with the present invention;

Figure 18C is a side elevational view of the nozzle body of Figure 18A disposed within the interior of a cavity in accordance with the present invention; Figure 19A is a top plan view of a nozzle body of the device in accordance with a seventeenth embodiment of the present invention;

Figure 19B is a perspective view from the bottom of the nozzle body of Figure 19A in accordance with the present invention; and

Figure 19C is a side elevational view of the nozzle body of Figure 19A disposed within the interior of a cavity in accordance with the present invention. Detailed Description of the Invention

The present invention is directed generally to devices and methods of using such devices for removing a flowable material such as a fluid contained within a vessel or cavity. Broadly, the device of the present invention includes a nozzle body configured for removing the flowable material from the vessel or cavity, and negative pressure generating means operatively associated with the nozzle body for generating negative pressure sufficient to draw the flowable material into the nozzle body in a manner that substantially minimizes damage or disruption of the vessel or cavity. In one embodiment of the present invention, the nozzle body may be modified to allow use of negative pressure sufficient to remove the fluid from the vessel or cavity.

The device of the present invention is specifically designed to direct negative pressures associated with removal, aspiration, draining or suctioning away from the distal end thereof, thereby significantly minimizing damage or disruption to immediate areas of the vessel or cavity (e.g., mucosal lining of tissue). For example, conventional devices which utilize negative pressure proximate to the vessel or cavity wall can result in occlusion or damage to the wall when the device is placed proximate thereto. This is the reason why conventional devices are typically positioned away from vessel or cavity walls during removal of the flowable material. In the present invention, the design of the present device allows the device to be placed substantially closer to the surface of the vessel or cavity, thereby greatly enhancing removal of the flowable material from the site. In this manner, the present device allows greater levels of negative pressure to be used for improved performance including, for example, enhanced rate and amount of removal, while maintaining safety and reliability.

In the present invention, devices, including medical and non-medical devices and kits comprising a plurality of such devices form part of the invention. During operation, the device of the present invention is used to draw or remove a flowable material such as a fluid at a site within the interior of a cavity or vessel, while avoiding or at least substantially minimizing any damage, injury or disruption to the surrounding inside surfaces of the interior of a cavity or vessel due to high back pressure.

As the present invention relates to medical applications, the methods and devices of the present invention can be used to suction, aspirate, siphon, drain or remove any flowable materials such as fluids without causing trauma to any tissue or organs in contact with or in proximity to the present device. Examples include removal of ascites, chest and/or knee drainage, clearance of lungs/trachea, removal of fluid or mucous secretions accumulating in the endotracheal space or the lungs, removal of fluid or gastric materials in the stomach, removal of air or blood in the pleural cavity, removal of blood and other fluids from the interior of the body, and the like.

The novel method and design of the present device provides for safe application of negative pressure generated by, for example, a pump assembly, gravity, and the like, such that the flowable material such as fluids in the cavity can be removed away from the tissue or organs because of the generation of at least a partial vacuum. In this manner, any tissue or organ damage or injury that may be inflicted by high back pressure arising from typical suction devices, including tissue abrasion, organ trauma, hematoma, and the like, can be avoided or at least substantially minimized through implementation of the present methods and devices.

It is understood that the present invention is not limited to the use of the nozzle body embodiment shown and described herein, but encompasses any nozzle body embodiment modified to allow use of negative pressure sufficient to remove the flowable material such as fluids from the vessel or cavity. Other embodiments of the nozzle body can be used as long as the generated negative pressure does not adversely affect the walls or surface of the vessel or cavity. In one embodiment of the present invention, there is provided a device generally including a nozzle body having an outlet, a first side portion impermeable to the flowable material located distally from the outlet, and a second side portion located proximate to the outlet and being permeable to the flowable material, wherein the second side portion is in fluid communication therethrough with the outlet. The device of the present invention further includes negative pressure generating means operatively associated with the outlet of the nozzle body for generating negative pressure at the second side portion of the nozzle body sufficient to draw the flowable material therein without damaging or substantially disrupting the vessel or cavity.

It is noted that the device of the present invention can be placed such that drainage occurs without the need for negative pressure such as by generating or maintaining ambient pressure at the site. In addition, negative pressure can be used to initiate drainage such as occurs when a fluid is siphoned from a site.

As used herein, the terms "flowable material" shall refer broadly to any material exhibiting flowable characteristics including fluids, fluid-based materials and flowable solids, which may be transported from a site located within the interior of a cavity or vessel. The flowable material is generally present in the interior of a cavity or vessel which is then drawn into the device for removal. Flowable materials include gases, liquids, and flowable solids, and mixed media materials such as slurries containing solids in liquids, as well as emulsions, suspensions, colloids and the like, and fine particle or granular solids, which may require removal from a patient. The flowable material, which is to be removed from the cavity, includes body-generated fluids (e.g., mucus, blood serum, vomit, secretions, synovial fluid, peritoneal fluid), which may contain particles of tissue and the like. As used herein, the terms "remove", "removing" or "removal" are intended to include, but not limited to, all forms of intake of a flowable material such as fluids into the present device including, but not limited to, suctioning, draining, siphoning and aspirating. Referring to the drawings and particularly to Figure 1 , there is shown for one embodiment of the present invention a device, identified generally by reference numeral 10, adapted for removing flowable material contained within a vessel or cavity. The device 10 as shown can be adapted for medical use, such as, for example, an intra-tracheal aspirating device for the removal of flowable material from a tracheal site. The device 10 includes a nozzle body 12 fluidly connected to an elongate flexible tubing 14, and a negative pressure generating assembly 16 in the form of, for example, a syringe. The nozzle body 12 and tubing 14 are each adapted for ease of insertion into a vessel or cavity of a warm-blooded animal such as a human.

The negative pressure generating assembly 16 includes a tubular barrel 18 having a first end 20 and a second end 22, an inlet 24 located at the first end 20, and a movable plunger 26 fitting tightly within the barrel 18 at the second end thereof. The barrel 18 defines a storage area 28 for receiving the flowable material (e.g., tissue and irrigation solution) from a site for a removal operation. The plunger 26 can be pulled along inside the barrel 18, allowing the assembly 16 to generate negative pressure sufficient to draw the flowable material into the storage area 28 from the removal site via the tubing 14 and nozzle body 12 as will be described hereinafter.

It will be understood that the negative pressure generating assembly 16 is intended to encompass any arrangement or mechanism capable of producing a desired level of reduced or negative pressure to initiate a suctioning effect in the nozzle body 12. Such negative pressure generating assembly 16 may be selected from a siphon, a displacement pump, a vacuum source, and the like. The negative pressure generating assembly 16 may be configured to provide either intermittent pressure or continuous suction typically in the range of 100 kPa to 100 mPa.

The device 10 of the present invention may be constructed of any suitable solid material, preferably biologically inert, including metals (e.g. titanium), alloys (e.g. steel), composites (e.g. fiber reinforced plastics), plastics and the like. For medical applications, the preferred material is medical grade plastic such as polycarbonate (e.g. Makrolon® available from Bayer Material Science). In reference to Figures 2A-2E, there is shown an embodiment of a nozzle body identified generally by reference numeral 12 modified for use in the present invention. The nozzle body 12 of the device 10 includes an outlet 30, a first side portion 32 being impermeable to a flowable material and located at a distal end 34 from the outlet 30, and a second side portion 36 being permeable to flowable material and located at a proximal end 38 near the outlet 30. The first side portion 32 includes a truncated end surface 44 located opposite from the outlet 30. The outlet 30 of the nozzle body 12 is fluidly connected to the tubing 14 with the other end of the tubing 14 fluidly connected to the negative pressure generating assembly 16 (as shown best in Figure 1 ). The nozzle body 12 further includes a flange 40 extending along the periphery thereof, and a plurality of inlets or apertures 42 disposed in the first side portion 32 along the flange 40. The flange 40 provides a barrier keeping the walls or interior of the cavity or vessel away from inlets 42, thereby preventing obstruction or blockage of the device 10.

As shown in the Figure 2D, the first and second side portions 32 and 36, respectively, may be constructed as separable units for one embodiment of the present invention. The nozzle body 12 is composed of a distal unit 46 comprising the first side portion 32 and the flange 40, and a proximal unit 48 comprising the outlet 30, the second side portion 36, and the inlets 42. The flange 40 of the distal unit 46 is configured for receiving and mating with a lower edge portion 50 of the proximal unit 48 to provide a tight, fluid seal fit. In this manner, the proximal and distal units 48 and 46, respectively, are joined at the flange 40. The distal unit 46 further includes an externally threaded post 52 configured for threaded engagement with a corresponding internally threaded interior surface (not shown) of the proximal unit 48. The resulting threaded engagement between the units 46 and 48 provides a secure fluid-tight coupling. Together, the coupled proximal and distal units 48 and 46, respectively, form an inner volume 54 through which a flowable material such as a fluid passes through the inlets 42 to the outlet 30.

It will be understood that the joinder of the two units may be achieved through any suitable means including, but not limited to, snap or press-fit arrangements, welding means, adhesive means, and the like, or combinations thereof. The joinder may occur when a portion of the two units are hingedly connected to each other and the respective remaining portions of the two units may be separated from each other about the hinge and coupled together in the operative position by any of the suitable means described above.

The selection of a suitable means of joinder will depend in part on the type of material used to produce the nozzle body 12. The second side portion 36 tapers inwardly from the flange 40 toward the outlet 30 to form a curvilinear concave surface, while the first side portion 32 tapers inwardly from the flange 40 toward the truncated end surface 44 to form a forward tapered surface. The curvilinear concave surface provides the site for the inlets 42 through which the flowable material is drawn rearward of the forward tapered surface of the first side portion 32 into the inner volume 54 during removal. In this manner, the nozzle body 12 draws the flowable material into the inner volume 54, while avoiding damage, injury or disruption to the surrounding areas of the interior of a cavity or vessel. It will be understood that the configuration of the second side portion 36 is not limited to a concave surface, and that the surface may be straight (e.g., a conical surface) or convex (e.g., a spherical or hemispherical surface) depending on the desired parameters of the nozzle body 12 as will be described hereinafter.

The first side portion 32 of the nozzle body 12 as shown in the embodiment of Figures 2A-2E is closed and prevents flowable material from being drawn ahead of the nozzle body 12. Accordingly, the shape of the first side portion 32 may not be critical and may be tapered as specifically shown in Figures 2A-2E or assume other shapes such as a flat, cylindrical, rectangular, cube-like, polygonal, and the like. From a manufacturing standpoint, a tapered profile is desired because of the need for less material to form the nozzle body 12.

It is noted that the present invention is intended to encompass any size, configuration, and shape necessary to facilitate the transfer of flowable material from a site within the interior of a desired cavity or vessel.

As shown in Figure 2E, the inlets 42 are oriented at an angle measured from the longitudinal axis of the nozzle body 12 which in part determines the flow path of the flowable material from the inside surface of the cavity or vessel at the site of the removal operation. The longitudinal axis of the nozzle body 12 is identified by reference numeral 56 as oriented through the outlet 30 in the rearward direction, while the longitudinal axis of an inlet 42 in the second side portion 36 is identified by reference numeral 58. The axis 58 is tilted or offset by an angle a which is referred to herein as the angle of tilt. In a preferred embodiment of the present invention, the angle of tilt (a) is in the range of up to about 90°, more preferably from about 10° to 80°, and most preferably from about 20° to 70°. The angle of tilt, as specifically shown in Figure 2E, is about 45°.

The number, size and position of the inlets 42 will depend on whether all or only a portion of the inside surface of the cavity or vessel is to be treated or the rate and configuration of maximizing flow necessary to implement the removal operation. The number and size of the inlets 42 may also depend in part on the nature of the flowable material. The parameters of the inlets 42 in the device 10 can be controlled to match the physical properties of the materials (e.g., viscosity) to be removed, the acceptable amount of material to be left behind, and the appropriate removal force to be used. Generally, thick or viscous materials containing a relatively large amount of solid particles (e.g. slurries, suspensions, tissue, debris and the like) will require larger inlets than would be required for relatively easily flowable materials such as aqueous solutions. In removing flowable materials from a vessel or cavity, it is preferable to employ equally spaced inlets 42 having identical or similar sizes.

The contour or configuration of the nozzle body 12 may be modified to optimize the suitable matching or fit to the size and shape of the site to be treated and to optimize the flow cross sectional area of the inlets 42 depending on the type of flowable material encountered. Accordingly, the second side portion 36 can be modified to include a concave profile, a convex profile to yield a spherical or hemispherical surface shape or a level or planar profile to yield a conical or cone-like surface shape. To increase the inlet size, the second side portion 36 can be modified, for example, to support a more convex surface configuration.

In medical applications, the nozzle used in the present invention can be used to transfer a flowable material from any inside surface of a cavity or vessel found therein, including, but not limited to the trachea, esophagus, vagina, anus, nasal passages, ear canals, joints, and the like. For these applications, unlike non-medical applications, the position and dimension of the inlets and the size of the nozzle body 12 falls within a relative narrow range as described below.

In preferred embodiments of medical applications, the diameter of the flange 40 will typically be up to 10mm, more typically 2 to 8 mm. The diameter of the inlets 42 will typically be in the range of from about 0.01 mm to 0.1 mm. The number of inlets 42 utilized about the entire circumference of the second side portion 36 is limited only by the ability to provide inlets 42 which are adequately spaced apart from each other. In some applications, the number of inlets 42 may be a hundred or more, although typically no more than seventy-two inlets 42 will be used.

In a preferred embodiment of the present invention, the number of inlets 42 will be from two to eight, more preferably from six to eight. Thus, in a preferred embodiment for uniform treatment of the entire circumference of a cavity or vessel, the inlets 42 will be spaced apart around the circumference of the active surface from 180° to 45°, more typically 60° to 45°. Preferably, the spacing between inlets 42 will be at least 5° (i.e., no more than seventy-two inlets around the circumference).

As previously indicated, the present invention may be used for medical applications as well as non-medical applications such as cleaning pipes of various diameters used to transport chemicals such as petroleum products and the like or recovering excess material in vessels by controlled removal, siphoning, aspiration or drainage. Under these circumstances and in these embodiments, the nozzle body 12 used in the present invention may reach a significant size wherein the nozzle body 12 may range from several inches to several feet in length with the inlets ranging from less than an inch up to and exceeding one foot in diameter.

It is noted that the construction of the device is within the skill of the art and a preferred means of construction especially for use with plastic materials is to form molds of the device 10. In producing the molded product, dimples or indentations may be provided where the inlets 42 appear in the nozzle body 12. The dimples (i.e. indentations) may be easily pierced to provide entry to the cavity or vessel when the device 10 is ready for use. In a further embodiment of the present invention, there is provided a method of removing a flowable material such as a fluid contained within a vessel or cavity, where the method comprises inserting the device into the vessel or cavity, positioning the nozzle body within the flowable material to the extent necessary for the second side portion to be proximate the flowable material and remote from the surface of the vessel or cavity, and generating negative pressure at the second side portion of the nozzle body sufficient to draw the flowable material from the vessel or cavity into the nozzle body without damaging or substantially disrupting the vessel or cavity.

In reference to Figure 3, the operation of the device 10 will be described herein. The nozzle body 12 and the tubing 14 is inserted through an opening (e.g., oral cavity) in the vessel or cavity 60 (e.g., trachea) defined by an inner surface 62. The nozzle body 12 is positioned at a selected removal site 62 containing a flowable material 66 such as mucous secretions. The first side portion 32 of the nozzle body 12 is placed near the inner surface 62 of the cavity 60, while the inlets 42 on the second side portion 36 are positioned away from the inner surface 62. The first side portion 32 and truncated end surface 44 may be positioned in contact with the inner surface 62.

Negative pressure is then applied at the site 64 via the negative pressure generating assembly 16 (e.g., syringe) by drawing the plunger 26 away from the syringe barrel 18. The resulting negative pressure suctions the flowable material 66 through the inlets 42 of the nozzle body 12. The flowable material 66 thereafter moves through the inner volume 54 of the nozzle body 12 into the tubing 14 via the outlet 30. The flowable material 66 is received and retained in the storage area 28 of the syringe barrel 18. The position of the inlets 42 on the nozzle body 12 minimizes the effects of the back pressure generated by the suction action on the inside surface 62 of the cavity 60. As a consequence, the risk of clogging or occlusion which can potentially damage the surrounding tissue is substantially minimized or avoided.

Also as shown clearly in Figure 3, the inlets 42 are positioned away from the walls of the vessel 60. As a consequence there is much less likelihood that the inlets 42 will become occluded when attempting to remove the flowable material as compared with prior art devices.

In another embodiment of the present invention, there is provided a kit which comprises a plurality of the devices described above. In a specific embodiment of the invention, a plurality of devices may be included in a kit with at least some of the devices with nozzle bodies having different distribution patterns of the inlets and/or having different sized inlets. For example, a kit may contain a plurality of devices with nozzle bodies of different distributions of inlets with apertures dimensioned for use in a particular cavity (e.g., trachea). The number of inlets will depend in part on the size of the apertures and the extent of the surface area of the active surface.

In reference to Figures 4A-4C, there is shown a nozzle body identified generally by reference numeral 70 for a second embodiment of the present invention. The nozzle body 70 is structurally and functionally similar to the embodiment of Figures 2A-2E. In the present embodiment, the nozzle body 70 includes a flattened or truncated first side portion 72 disposed opposite from an outlet 74, and a second side portion 76 with a straight profile to form a low conical shape. Four apertures or inlets 78 are disposed radially spaced-apart from one another in the second side portion 76. The truncated first side portion 72 allows the nozzle body 70 to be placed close to the inner surface of the cavity 60 thereby facilitating removal of a greater amount of the flowable material 66. In reference to Figures 5A-5C, there is shown a nozzle body identified generally by reference numeral 80 for a third embodiment of the present invention. The nozzle body 80 is structurally and functionally similar to the embodiment of Figures 4A-4C. In the present embodiment, the nozzle body 80 includes a flattened or truncated first side portion 82 disposed opposite from an outlet 84, and a second side portion 86 with a straight profile to form a high conical shape. Four apertures or inlets 88 are disposed radially spaced-apart from one another in the second side portion 86. The truncated first side portion 82 allows the nozzle body 80 to be placed close to the inner surface of the cavity 60 thereby facilitating removal of a greater amount of the flowable material 66. The high conical shape of the second side portion 86 allows the size of the inlets 88 to be increased, which better accommodates the passing of thicker or more viscous flowable material 66 therethrough.

In reference to Figures 6A-6C, there is shown a nozzle body identified generally by reference numeral 90 for a fourth embodiment of the present invention. The nozzle body 90 is structurally and functionally similar to the embodiment of Figures 4A-4C. In the present embodiment, the nozzle body 90 includes a second side portion 92 with a convex profile to form a low hemispherical shape. Four apertures or inlets 94 are disposed radially spaced-apart from one another in the second side portion 92.

In reference to Figures 7A-7C, there is shown a nozzle body identified generally by reference numeral 100 for a fifth embodiment of the present invention. The nozzle body 100 is structurally and functionally similar to the embodiment of Figures 7A-7C. In the present embodiment, the nozzle body 100 includes a second side portion 102 with a convex profile to form a high hemispherical shape. Four apertures or inlets 104 are disposed radially spaced-apart from one another in the second side portion 102.

In reference to Figures 8A-8C, there is shown a nozzle body identified generally by reference numeral 1 10 for a sixth embodiment of the present invention. The nozzle body 1 10 is structurally and functionally similar to the embodiment of Figures 4A-4C. In the present embodiment, the nozzle body 1 10 includes a second side portion 1 12 with a straight profile to form a low conical shape. Two apertures or inlets 1 14 are disposed radially spaced-apart from one another in the second side portion 1 12. In reference to Figures 9A-9C, there is shown a nozzle body identified generally by reference numeral 120 for a seventh embodiment of the present invention. The nozzle body 120 is structurally and functionally similar to the embodiment of Figures 5A-5C. In the present embodiment, the nozzle body 120 includes a second side portion 122 with a straight profile to form a high conical shape. Two apertures or inlets 124 are disposed radially spaced-apart from one another in the second side portion 122.

In reference to Figures 10A-10C, there is shown a nozzle body identified generally by reference numeral 130 for an eighth embodiment of the present invention. The nozzle body 130 is structurally and functionally similar to the embodiment of Figures 6A-6C. In the present embodiment, the nozzle body 130 includes a second side portion 132 with a convex profile to form a low hemispherical shape. Two apertures or inlets 134 are disposed radially spaced-apart from one another in the second side portion 132.

In reference to Figures 1 1 A-1 1 C, there is shown a nozzle body identified generally by reference numeral 140 for a ninth embodiment of the present invention. The nozzle body 140 is structurally and functionally similar to the embodiment of Figures 7A-7C. In the present embodiment, the nozzle body 140 includes a second side portion 142 with a convex profile to form a high hemispherical shape. Two apertures or inlets 144 are disposed radially spaced-apart from one another in the second side portion 142. In reference to Figures 12A-12C, there is shown a nozzle body identified generally by reference numeral 150 for a tenth embodiment of the present invention.

The nozzle body 150 is structurally and functionally similar to the embodiment of

Figures 4A-4C. In the present embodiment, the nozzle body 150 includes a second side portion 152 with a straight profile to form a low conical shape. Eight apertures or inlets 154 are disposed radially spaced-apart from one another to form a single row in the second side portion 152.

In reference to Figures 13A-13C, there is shown a nozzle body identified generally by reference numeral 160 for an eleventh embodiment of the present invention. The nozzle body 160 is structurally and functionally similar to the embodiment of Figures 5A-5C. In the present embodiment, the nozzle body 160 includes a second side portion 162 with a straight profile to form a high conical shape. Eight apertures or inlets 164 are disposed radially spaced-apart from one another to form a single row arrangement in the second side portion 162.

In reference to Figures 14A-14C, there is shown a nozzle body identified generally by reference numeral 170 for a twelfth embodiment of the present invention. The nozzle body 170 is structurally and functionally similar to the embodiment of Figures 13A-13C. In the present embodiment, the nozzle body 170 includes a second side portion 172 with a straight profile to form a high conical shape. Eight apertures or inlets 174 are disposed radially spaced-apart from one another to form a single row arrangement proximate the lower end of the second side portion 172.

In reference to Figures 15A-15C, there is shown a nozzle body identified generally by reference numeral 180 for a thirteenth embodiment of the present invention. The nozzle body 180 is structurally and functionally similar to the embodiments of Figures 13A-13C and 14A-14C, respectively. In the present embodiment, the nozzle body 180 includes a second side portion 182 with a straight profile to form a high conical shape. Sixteen apertures or inlets 184 are disposed radially spaced-apart from one another to form a double row arrangement in the second side portion 182.

In reference to Figures 16A-16C, there is shown a nozzle body identified generally by reference numeral 190 for a fourteenth embodiment of the present invention. The nozzle body 190 is structurally and functionally similar to the embodiment of Figures 6A-6C. In the present embodiment, the nozzle body 190 includes a second side portion 192 with a convex profile to form a low hemispherical shape. Eight apertures or inlets 194 are disposed radially spaced-apart from one another to form a single row arrangement in the second side portion 192.

In reference to Figures 17A-17C, there is shown a nozzle body identified generally by reference numeral 200 for a fifteenth embodiment of the present invention. The nozzle body 200 is structurally and functionally similar to the embodiment of Figures 7A-7C. In the present embodiment, the nozzle body 200 includes a second side portion 202 with a convex profile to form a high hemispherical shape. Eight apertures or inlets 204 are disposed radially spaced-apart from one another to form a single row arrangement in the second side portion 202.

In reference to Figures 18A-18C, there is shown a nozzle body identified generally by reference numeral 210 for a sixteenth embodiment of the present invention. The nozzle body 210 is structurally and functionally similar to the embodiment of Figures 17A-17C. In the present embodiment, the nozzle body 210 includes a second side portion 212 with a convex profile to form a high hemispherical shape. Eight apertures or inlets 214 are disposed radially spaced-apart from one another to form a single row arrangement proximate the lower end of the second side portion 212.

In reference to Figures 19A-19C, there is shown a nozzle body identified generally by reference numeral 220 for a seventeenth embodiment of the present invention. The nozzle body 220 is structurally and functionally similar to the embodiments of Figures 17A-17C and 18A-18C, respectively. In the present embodiment, the nozzle body 220 includes a second side portion 222 with a convex profile to form a high hemispherical shape. Sixteen apertures or inlets 224 are disposed radially spaced-apart from one another to form a double row arrangement in the second side portion 222.

In an alternative embodiment of the present invention, there is provided a kit which comprises a plurality of the nozzle bodies described above. In a specific embodiment of the invention, a plurality of nozzle bodies may be included in a kit with at least some of the nozzle bodies having different distribution patterns of the inlets and/or having different sized inlets, and different sizes and/or shapes/profiles. For example, a kit may contain a plurality of with nozzle bodies of different distributions of inlets with apertures dimensioned for use in a particular cavity (e.g., trachea). The number of inlets will depend in part on the size of the apertures and the extent of the surface area of the active surface. The foregoing discussion discloses and describes merely exemplary embodiments of the present invention. The embodiments depicted herein are illustrative and modifications to such embodiments within the skill of the art are encouraged by the present application. One skilled in the art will readily recognize from such discussion, and from the accompanying drawings and claims, that various changes, modifications and variations can be made therein without departing from the spirit and scope of the invention as defined in the following claims.

Claims

What is claimed:

1 . A device for removing flowable material contained within a vessel or cavity, said device comprising:

a nozzle body including:

an outlet;

a second side portion being permeable to the flowable material and located proximate to the outlet, wherein the second side portion is in fluid communication therethrough with the outlet; and

2. The device of claim 1 further comprising a flexible tubing fluidly connecting the outlet of the nozzle body to the negative pressure generating means.

3. The device of claim 1 wherein the negative pressure generating means is a pump.

4. The device of claim 3 wherein the pump is a syringe.

5. The device of claim 1 wherein the second side portion comprises:

at least one inlet disposed therein, said at least one inlet being in fluid communication with the outlet via an inner volume defined by the nozzle body; and said at least one inlet comprises a longitudinal axis having an angle of tilt in the range of up to 90° as measured from the longitudinal axis extending through the proximal end of the nozzle body.

6. The device of claim 1 comprising four inlets.

7. The device of claim 1 comprising eight inlets.

8. The device of claim 5 wherein the angle of tilt is in the range of from about 10° to 80°.

9. The device of claim 8 wherein the angle of tilt is in the range of from about 20° to 70°.

10. The device of claim 1 wherein second side portion comprises an exterior surface located on a side opposite from the first side portion.

1 1 . The device of claim 10 wherein the external surface of the second side portion of the nozzle body comprises a profile selected from the group consisting of a concave profile, a convex profile, a planar profile, and combinations thereof.

12. The device of claim 1 further comprising a flange extending peripherally around the nozzle body between the first and second side portions.

13. The device of claim 1 wherein the diameter of the flange is up to 10 mm.

14. The device of claim 13 wherein the diameter of the flange is from about 2 mm to 8 mm.

15. The device of claim 12 wherein the second side portion comprises a plurality of spaced-apart inlets disposed therein along the flange, said plurality of spaced- apart inlets being in fluid communication with the outlet via an inner volume defined by the nozzle body.

16. The device of claim 15 wherein said plurality of inlets each comprise a longitudinal axis having an angle of tilt in the range of up to 90° as measured from a longitudinal axis extending through the proximal end of the nozzle body.

17. The device of claim 16 wherein the angle of tilt is in the range of from about 10° to 80°.

18. The device of claim 17 wherein the angle of tilt is in the range of from about 20° to 70°.

19. The device of claim 1 wherein the first side portion of the nozzle body comprises a flat truncated surface.

20. The device of claim 1 wherein the first side portion of the nozzle body comprises a forward tapered surface.

21 . A nozzle body of a device for removing flowable material contained within a vessel or cavity, said nozzle body comprising:

22. A method of removing a flowable material contained within a vessel or cavity, said method comprising:

inserting the device of Claim 1 into said vessel or cavity;

generating negative pressure at the second side portion of the nozzle body sufficient to draw the flowable material from the vessel or cavity into the nozzle body without damaging or substantially disrupting the vessel or cavity.

23. A kit comprising a plurality of the devices of claim 1 .

24. A kit comprising a plurality of the nozzle bodies of claim 21 .