Patent Application
20220054770
This invention relates to an apparatus and process for producing an enriched medical suspension.
The present invention utilizes the Venturi effect to produce an enriched medical suspension for use in various applications. The apparatus of the present invention is simple to manufacture and use because it does not require an impeller and incorporated fan in order to create and dispense the enriched medical suspension.
The Venturi effect is an example of Bernoulli's principle, in the case of incompressible fluid, flow through a tube or pipe with a constriction in it. The fluid velocity must increase through the constriction to satisfy the equation of continuity, while its pressure must decrease due to conservation of energy; the gain in kinetic energy is supplied by a drop in pressure or a pressure gradient force.
The limiting case of the Venturi effect is choked flow, in which a constriction in a pipe or channel limits the total flow rate through the channel because the pressure cannot drop below zero in the constriction. Choked flow is used to control the delivery rate of water and other fluids through spigots and other types of valves. The portable apparatus of the present invention utilizes a source of pressurized medical fluid, to produce the desired pressure and flow for the effective creation of an enriched medical suspension.
It is, therefore, an object of the present invention to provide a medical fluid suspension generating apparatus including a Venturi-agitating tip assembly, a source of pressurized chemical solution, a source of a medical solution, and a dual lumen catheter connecting the Venturi-agitating tip assembly to the source of pressurized chemical solution and the source of the medical solution.
It also an object of the present invention to provide a medical fluid suspension generating apparatus wherein the source of pressurized chemical solution includes a compressed medical fluid unit.
It another object of the present invention to provide a medical fluid suspension generating apparatus wherein the source of the medical solution includes a syringe.
It a further object of the present invention to provide a medical fluid suspension generating apparatus wherein a micro-hose connects the source of pressurized chemical solution to a first lumen of the dual lumen catheter.
It also an object of the present invention to provide a medical fluid suspension generating apparatus wherein the source of the medical solution is connected to the second lumen of the dual lumen catheter.
It another object of the present invention to provide a medical fluid suspension generating apparatus wherein the syringe includes a one-way valve.
It a further object of the present invention to provide a medical fluid suspension generating apparatus wherein the Venturi-agitating tip assembly includes a spray tip.
It also an object of the present invention to provide a medical fluid suspension generating apparatus wherein the spray tip includes outlets oriented such that an enriched medical suspension is sprayed at an angle of 25 degrees to 65 degrees relative to a longitudinal axis of the Venturi-agitating tip assembly.
Other objects and advantages of the present invention will become apparent from the following detailed description when viewed conjunction with the accompanying drawings, which set forth certain embodiments of the invention
The detailed embodiments of the present invention are disclosed herein. It should be understood, however, that the disclosed embodiments are merely exemplary of the invention, which may be embodied in various forms. Therefore, the details disclosed herein are not to be interpreted as limiting, but merely as a basis for teaching one skilled in the art how to make and/or use the invention.
Referring to the various figures and embodiments, the medical fluid suspension generating delivery apparatus 100 for performing medical procedures includes a Venturi-agitating tip assembly (various embodiments of which are described below) composed of a multi-channel arrangement at a proximal first end thereof and a tip at a distal second end thereof. The delivery apparatus 100 also includes a compressed medical fluid unit 1 fluidly connected to the multi-channel arrangement at the proximal first end of the Venturi-agitating tip assembly and a medical solution 19 fluidly connected to the multi-channel arrangement at he proximal first end of the Venturi-agitating tip assembly. Pressurized chemical solution 18, from the compressed medical fluid unit 1, and the medical solution 19 are combined within the Venturi-agitating tip assembly in a manner generating an enriched medical suspension 21 that is ultimately dispensed from the suspension delivery apparatus 100. The enriched medical suspension 21 is then sprayed from the Venturi-agitating tip assembly. In accordance with a preferred embodiment, outlets at the tip of the Venturi-agitating tip assembly are oriented such that the enriched medical suspension 21 is sprayed at an angle of 25 degrees to 65 degrees, preferably 45 degrees, relative to the longitudinal axis of the Venturi-agitating tip assembly to ensure the enriched medical suspension 21 is sprayed directly onto the inner wall of the lumen being treated and is not entrained within the fluid flowing in the lumen, This prevents the need for the application of the enriched medical suspension 21 down the middle of the lumen and waiting for the enriched medical suspension 21 to disperse out to the inner wall of the lumen. While the various embodiments disclosed below show the Venturi-agitating tip assembly with three (3) outlets, it is contemplated as many as 16 outlets may be positioned about the tip of the Venturi-agitating tip assembly for spraying the enriched medical suspension. Further still, it is appreciated the outlets may be covered with membranes enhancing delivery of the enriched medical suspension. A method in accordance with the apparatus is also disclosed.
With reference to
With reference to
A micro-hose 256 connects the compressed medical fluid unit 1 to the first lumen 272 of the dual lumen catheter 260 at a proximal first end 266 of the dual lumen catheter 260 for the transmission of the pressurized chemical solution 18 from compressed medical fluid unit 1 to the Venturi-agitating tip assembly 280. As such, pressurized chemical solution 18 leaving the compressed medical fluid unit 1 enters the first lumen 272 of the dual lumen catheter 260 via the micro-hose 256. After passing through the first lumen 272 of the dual lumen catheter 260, the pressurized medical chemical solution 18 enters the Venturi-agitating tip assembly 280 of the suspension delivery catheter 2. As will be explained below in greater detail, the medical suspension 21 composed of the chemical solution 18 and the medical solution 19 generated at the Venturi-agitating tip assembly 280 is directly applied to a vein or artery requiring treatment with the medical suspension 21.
As to the connection of the medical solution 19 to the suspension delivery catheter 2, the medical solution 19 is delivered to the second lumen 274 of the dual lumen catheter 260 at the proximal first end 266 thereof, and ultimately to the Venturi-agitating tip assembly 280, via a container, in particular, the syringe 290, connected to the second lumen 274 of the dual lumen catheter 260 by a supply line 216. As mentioned above, the syringe 290 includes a one-way valve 291 at its outlet to ensure that medical solution 19 from the syringe 290 only flows out of the syringe 290, preventing reflux back into the syringe 290 or the compressible syringe 12 of the compressed medical fluid unit 1. After passing through the second lumen 274 of the dual lumen catheter 260, the medical solution19 from the syringe 290 travels into the Venturi-agitating tip assembly 280 where it is combined with pressurized chemical solution 18 from the pressurized medical fluid unit 1 to form an enriched medical suspension 21.
The Venturi-agitating tip assembly 280 results in the spray of the enriched medical suspension 21 at an angle relative to a central axis of the Venturi-agitating tip assembly 280. In accordance with a preferred embodiment, and as will be discussed below with regard to the various embodiments of the Venturi-agitating tip assembly 280, the Venturi-agitating tip assembly 280 includes outlets 228 directing the enriched medical suspension 21 at an angle of 25 degrees to 65 degrees, preferably 45 degrees, relative to the central longitudinal axis of the Venturi-agitating tip assembly 280. By orienting the outlets at an angle as disclosed herein, the enriched medical suspension 21 is directed toward the walls of the vessel in which it is being dispensed.
It is appreciated various tip assemblies and enriched medical suspension generating structures may be employed in accordance with the present invention. In accordance with a first embodiment as shown with reference to
The first channel 320 and the second channel 322 are interconnected in a manner creating a Venturi effect causing the pressurized chemical solution to effectively pull the medical solution through the second channel 322 and into the mixing chamber 324. This is achieved by providing with the first channel 320 with a reduced diameter as it extends from the proximal first end 312 of the elongated body 310 (that is, the first end 320a of the first channel 320) to the central portion 326 of the Venturi-agitating tip assembly 380 (that is, the second end 320b of the first channel 320). In accordance with a preferred embodiment, the diameter of the first channel 320 decreases from a diameter of 0.038 inches adjacent the proximal first end 312 of the elongated body 310 to a diameter of 0.017 inches adjacent the mixing chamber 324.
As mentioned above, the second channel 322 is in fluid communication with the first channel 320. This is achieved by the provisional of a transverse channel 330 connecting the second end 320b of the first channel 320 with the second end 322b of the second channel 322. In particular, the second channel 322 includes a first end 322a adjacent the proximal first end 312 of the elongated body 310 and second end 322b adjacent the mixing chamber 324 (although not directly in fluid communication with the mixing chamber 324) and the transverse channel 330. In accordance with a preferred embodiment, the diameter of the second channel 322 is 0.031 inches and remains consistent as it extends from the first end 322a thereof to the second end 322b thereof.
The first lumen 372 of the dual lumen catheter 360 supplies the pressurized chemical solution and the second lumen 374 supplies the medical solution. As such, the first lumen 372 is connected to, and in fluid communication with, the first channel 320 of the Venturi-agitating tip assembly 380 and the second lumen 374 is connected to, and in fluid communication with, the second channel 322 of the Venturi-agitating tip assembly 380, in practice, the medical solution from the syringe 290 travels through the second lumen 374 of the dual lumen catheter 360 and into the second channel 322 when pressurized chemical solution enters the first channel 320 and passes the transverse channel 330 as it flows into the mixing chamber 324 after being actuated and released from the compressed medical fluid unit 1. The pressurized chemical solution entering, and passing through, the Venturi-agitating tip assembly 380 imparts negative pressure on the medical solution in the syringe 290 and draws the medical solution from the syringe 290 through the second channel 322, through the second lumen 374 of the dual lumen catheter 360, through the transverse channel 330, and into the mixing chamber 324 due to the Venturi effect. The medical solution and the pressurized chemical solution are then mixed within the mixing chamber 324 to form enriched medical suspension. The syringe plunger 290p is used to regulate or stop flow of medical solution of chemical solution from the syringe 290.
The pressurized chemical solution and medical solution mixing in the mixing chamber 324 are then forced through the spray tip 328 from which the enriched medical suspension is sprayed upon the inner lumen of a vessel. The spray tip 328 includes a plurality of outlets 328a oriented at an angle of 25 degrees to 65 degrees, preferably 45 degrees, relative to the central longitudinal axis of the Venturi-agitating tip assembly 380. The force of the pressurized chemical solution traveling through the Venturi-agitating tip assembly 380 and exiting through the spray tip 328 as part of an enriched medical suspension projects the enriched medical suspension from the distal second end 384 of the Venturi-agitating tip assembly 380 as a spray and onto the inner lumen of a vessel.
In accordance with a second embodiment as shown with reference to
The proximal first end 480a of the Venturi-agitating tip assembly 480, in particular, the proximal first end 412 of the elongated body 410 is formed with two projections 432, 434 shaped and dimensioned for engagement within the outer first lumen 472 of the catheter 460 in a manner blocking a substantial portion of the outer first lumen 472. The two projections 432, 434 are arcuate members shaped and dimensioned to respectively block substantial portions of the first and second semicircular passageways 475a, 475b while creating four small passageways 436, each of approximately 0.031 inches (along the Y-axis as shown in
The remainder of the Venturi-agitating tip assembly 480 includes a central mixing chamber 424 that s in fluid communication with the second lumen 474 and the four small passageways 436 feeding pressurized chemical solution from the first lumen 472. Secured to, and closing off, the second end 414 of the elongated body 410 is a spray tip 428, which is thereby at the distal second end 480b of the Venturi-agitating tip assembly 480. Attachment of the spray tip 428 to the elongated body 410 is achieved by providing the spray tip 428 with a projection 438 that seats within the opening at the second end 414 of the elongated body 410.
The first lumen 472 and the second lumen 474 are interconnected in a manner causing the pressurized chemical solution to effectively pull the medical solution through the second lumen 474 and into the mixing chamber 424. 1n practice, the medical solution from the syringe290 travels through the second lumen 474 of the dual lumen catheter 460 and into the mixing chamber 424 when pressurized chemical solution passes through the four small passageways 436 and enters the mixing chamber 424 (where the medical solution from the syringe 290 and the pressurized chemical solution mix to form an enriched medical suspension) after being actuated and released from compressed medical fluid unit 1. The pressurized chemical solution entering, and passing through, the mixing chamber 424 imparts negative pressure on the medical solution in syringe 290 and draws the medical solution from the syringe 290 through the second lumen 474 and into the mixing chamber 424. The syringe plunger 290p is used to regulate or stop flow of the medical solution from the syringe 290.
The pressurized chemical solution and medical solution mixing in the mixing chamber 424 are then forced through the spray tip 428 from which an enriched medical suspension is sprayed upon the inner surface of a lumen. The spray tip 428 includes a plurality of outlets 428a oriented at an angle of 25 degrees to 65 degrees, preferably 45 degrees, relative to the central longitudinal axis of the Venturi-agitating tip assembly 480. The force of the pressurized chemical solution traveling through the Venturi-agitating tip assembly 480 and exiting through the spray tip 428 as part of an enriched medical suspension projects the enriched medical suspension from the distal second end 484 of the Venturi-agitating tip assembly 480 as a spray and onto the inner lumen of a vessel.
In accordance with a third embodiment as shown with reference to
The proximal first end 712 of the elongated body 710 at the proximal first end 780a of the Venturi-agitating tip assembly 780 includes first, second and third inputs 716, 717, 718 for attachment to the multi-lumen catheter 760. The first and second inputs 716, 717 lead to a first channel 720 and the third input 718 to a second channel 722. As such, the proximal first end 712 of the elongated body 710 at the proximal first end 780a of the Venturi-agitating tip assembly 780 is formed with two circular tubular projections 732, 734, defining the first and second inputs 716, 717. The circular tubular projections 732, 734 (each with an inner diameter of 0.027 inches and an outer diameter of 0.039 inches) are shaped and dimensioned for engagement within the first and second lumens 772, 773 of the catheter 760 in a manner allowing for the flow of fluid from the first and second lumens 772, 773 and into the Venturi-agitating tip assembly 780. The two circular tubular projections 732, 734 are shaped and dimensioned to fit within the first and second lumens 772, 773 while maintaining passageways for the passage of pressurized chemical solution therethrough.
The first and second channels 720, 722 lead to, and are in fluid communication with, a mixing chamber 724 located in the central portion 726 of the Venturi-agitating tip assembly 780, that is, between the proximal first end 712 and the distal second end 714 of the elongated body. Secured to the distal second end 714 of the elongated body 710, and positioned at the distal second end 780b of the Venturi-agitating tip assembly, is a tip 728 having three outlets 728a, 728b, 728c extending from the mixing chamber 724 to the exterior at the distal end of the Venturi-agitating tip assembly 780 at an angle of 25 degrees to 65 degrees, preferably 45 degrees, relative to the central longitudinal axis of the Venturi-agitating tip assembly 780.
The first channel 720 and the second channel 722 are interconnected in a manner creating a Venturi effect causing the pressurized chemical solution to effectively pull the medical solution through the second channel 722 and into the mixing chamber 724. This is achieved by providing the first channel 720 with a reduced diameter (decreasing from 0.038 inches to 0.017 inches) as it extends from the proximal first end 712 of the elongated body 710 (that is, the first end 720a of the first channel 720) to the central portion 726 of the Venturi-agitating tip assembly 780 (that is, the second end 720b of the first channel 720). In accordance with a preferred embodiment, the diameter of the first channel 720 decreases from a diameter of 0.038 inches adjacent the proximal first end 712 of the elongated body 710 to a diameter of 0.017 inches adjacent the mixing chamber 724.
As mentioned above, the second channel 722 is in fluid communication with the first channel 720. This is achieved by the provisional of a transverse channel 730 connecting the second end 720b of the first channel 720 with the second end 722b of the second channel 722. In particular, the second channel 722 includes a first end 722a adjacent the proximal first end 712 of the elongated body 710 and a second end 722b adjacent the mixing chamber 724 (although not directly in fluid communication with the mixing chamber 724) and the transverse channel 730. In accordance with a preferred embodiment, the diameter of the second channel 722 is 0.047 inches and remains consistent as it extends from the first end 722a thereof to the second end 722b thereof.
The first and second lumens 772, 773 supply the pressurized chemical solution and the third lumen 774 supplies the medical solution. As such, the first and second lumens 772, 773 are connected to, and in fluid communication with, the first channel 720 of the Venturi-agitating tip assembly 780. The third lumen 774 is connected to, and in fluid communication with, the second channel 722 of the Venturi-agitating tip assembly 780. In practice, the medical solution from syringe 290 travels through third lumen 774 of multi-lumen lumen catheter 760 and into the second channel 722 when pressurized chemical solution enters the first channel 720 and passes the transverse channel 730 (having a size of 0.020 inches) into the mixing chamber 724 after being actuated and released from compressed medical fluid unit 1. The pressurized chemical solution entering, and passing through, the Venturi-agitating tip assembly 780 imparts negative pressure on the medical solution in syringe 290 and draws the medical solution from the syringe 290 through second channel 722, through the third lumen 774 of the dual lumen catheter 760, and into the mixing chamber 724 due to the Venturi effect. The syringe plunger 290p is used to regulate or stop flow of medical solution from the syringe 290.
The pressurized chemical solution and medical solution mixing in the mixing chamber 724 form an enriched medical suspension that is then forced through the outlets 728a-c of the spray tip 728. The force of the pressurized medical chemical solution raveling through the Venturi-agitating tip assembly 780 and exiting through the spray tip 728 as part of an enriched medical suspension projects the enriched medical suspension from the distal second end 784 of the Venturi-agitating tip assembly 780 as a spray and onto the inner lumen of a vessel.
While the outlets of the spray tip in the embodiments disclosed above with reference to
For example, and with reference to
In accordance with the various embodiments described above, the enriched medical suspension exiting the Venturi-agitating tip assembly is directed to a vessel requiring treatment. In accordance with a preferred embodiment, the method for treatment in accordance with the present invention is achieved in the following manner. The first end of the suspension delivery catheter, that is, Venturi-agitating tip assembly is introduced into a diseased/varicosed vein requiring treatment such that the first end of Venturi-agitating tip assembly is positioned beyond the section of vein requiring treatment. The second end of the delivery catheter is coupled to the compressed medical fluid unit and the syringe. At this point, the compressed medical fluid unit is actuated to supply pressurized chemical solution to the suspension delivery catheter and an enriched medical suspension is produced at the Venturi-agitating tip assembly of the suspension delivery catheter. The enriched medical suspension sprays from the first end of Venturi-agitating tip assembly into the section of vein requiring treatment. For example, and where the enriched medical suspension includes a sclerosant for the destruction of a diseased vein, as the catheter is withdrawn from the vein, the enriched medical suspension is sprayed into the vein at various segments causing the vein to go into spasm resulting in eventual destruction of the diseased vein. Where the present invention is used in the treatment of the arterial or venous system without the goal of spasm or vessel destruction, the enriched medical suspension is sprayed, or otherwise delivered, as required for the procedure being performed.
It s appreciated this procedure can be performed under ultrasound guidance or radiograph in order for the physician to control the amount of liquid to mix with the pressurized chemical solution to form the enriched medical suspension.
In addition to the treatment of diseased veins as discussed above, the present suspension delivery catheter may be used in the treatment of various vascular ailments, The potential treatments that may employ the present suspension delivery catheter include, but are not limited to the following, oncology medical solutions, microbeads, magnetic beads or particles for thrombus treatment, metallic beads or particles for thrombus treatment, embolics, driving drugs through the blood-brain barrier for neurological conditions, driving or delivering TPA (Tissue Plasminogen Activator) for thrombolytic usage, etc.
It is appreciated that where microparticles are used in conjunction with the enriched medical suspension composed of the chemical and medical solutions, saline may be used with the microparticles, so as to place the microparticles into suspension.
While this detailed description has set forth particularly preferred embodiments of the apparatus of this invention, numerous modifications and variations of the structure of this invention, all within the scope of the invention, will readily occur to those skilled in the art. Accordingly, it is understood that this description is illustrative only of the principles of the invention and is not limitative thereof.
Although specific features of the invention are shown in some of the drawings and not others, this is for convenience only, as each feature may be combined with any and all of the other features in accordance with this invention.
While the preferred embodiments have been shown and described, it will be understood that there is no intent to limit the invention by such disclosure, but rather, it is intended to cover all modifications and alternative constructions failing within the spirit and scope of the invention.
This application claims the benefit of U.S. Provisional Patent Application Ser. No. 62/653,635, entitled “APPARATUS AND METHOD FOR PRODUCING AN ENRICHED MEDICAL CONTRAST SUSPENSION,” filed Apr. 6, 2018.
| Number | Date | Country | |
|---|---|---|---|
| 62653635 | Apr 2018 | US |
| Number | Date | Country | |
|---|---|---|---|
| Parent | 16376841 | Apr 2019 | US |
| Child | 17453296 | US |
