WO2022122099A1

WO2022122099A1 - Fluid pressure distribution for dosing and discharging of fluids

Info

Publication number: WO2022122099A1
Application number: PCT/DK2021/000337
Authority: WO
Inventors: Mikkel Styrbjørn Hartvig ANDERSEN
Original assignee: Andersen Mikkel Styrbjoern Hartvig
Priority date: 2020-12-09
Filing date: 2021-11-09
Publication date: 2022-06-16
Also published as: EP4259245A1

Abstract

The present invention consists of 8 continous basic elements. A First Tube (Figure 5; 1} containing a moveable First Membrane (Figure 5; 2) attached to a Connector (Figur 5; 4) to a Second Tube (Figure 5; 7) with a moveable Second Membrane (Figur 5; 5} succeeded by a Dose Fluid (Figure 5; 6} completed by a Hole (Figur 5; 8} where the Dose Fluid is released. Between First Membrane and Second Membrane is a Transportation Fluid {Figur 5; 3) that flow longitudinally through a hole in the Connector from the First Tube to the Second Tube encapsulating the Transportation Fluid keeping the volume constant. Pressure applied to the First Membrane will be transmitted longitudinally (Figur 5; 97} on a transportation Fluid (Pascal's Law), press the Second Membrane thus releasing and discharging the Dose Fluid through a Hole. The invention free the design opportunities compared to existing techniques. The invention will especially improve delivery solutions in branches within medico, chemicals, drinks and other branches alike wherein dosing and discharging of fluids are utilized. See Figure 5 for visual support of the present invention.

Description

FLUID PRESSURE DISTRIBUTION

FOR DOSING AND DISCHARGING OF FLUIDS

Problem

Delivery of fluids done by a mechanical dosing- and delivery devices , typically work by pressuring a mechanical piston rod and its extensions resulting in solutions often straight and long ( Figur 9 ; A) . A design, that implies limitations to both function, design , precision and ergonomics due to the customization of the elongated piston solutions with long straight piston rods and their inevitable need for working lengths .

Solution

By utilizing fluids incompressible properties (except for very extreme conditions ) , pressure can be distributed through fluids by the use of fluid mechanics - Blaise Pascal ' s principles published in year 1663 ( Figure 2 ; Y , Z ) concerning fluid pressure distribution ( hydraulics ) - and thereby enabling multible more design solutions than by the use of linear mechanical solutions . Using the principles of Blaise Pascal also result in dosable delivery solutions can be designed more compressed as a whole - opposed to linear piston lengths and the associated working lengths - and do not limit the entirety of the design of a Dosing Delivery Solution . This is a factor in especially medical MDA' s (Multi Dose Applicators ) , that often has to be carried continually by the user and be smallest possible ( ie . pockets of pants ) or in environments where space or surroundings demand other solutions than long linear piston mechanics provide .

Background technique

The present invention utilize a known and used hydraulic technique invented and described by the french mathematician Blaise Pascal in 1653 and published in 1663. "Pascal ' s Law" ( aka "Pascal ' s Principle" or "The Principle of Transmission of Fluid Pressurization" ) is a principle in fluid dynamics stating, that a change in pressure at any time i a confined incompressible fluid will be transmitted throughout the whole fluid, so the change occurs everywhere within the confined fluid. The principle is referred to as "Pascal ' s Law" and defined as : "Pressure, applied on a fluid in a confined container , transmits pressure equally and undminished to all parts of the container and work perpendicularly on to the enclosing surfaces" .

This principle is also used in a previous invention for cementing bones by percutan vertebrae plastics - EP 1 614 403 Al - including 11 continous basic elements : A syringe ( cylindrical housing in plastic with a moveable piston rod attached to a rubber membrane ) with an end nozzle (with hole ) mounted on to a flexible tube of 1 , 5 meter in length , equal in diameter and larger than the nozzle diameter of the syringe that is mounted on to an adapter (plastic container like the syringe ) nozzle at the other end of the tube ( also larger diameter than the adapters nozzle and with a hole ) and the compartment of the adapter is closed by a second moveable membrane in order to compartmentalize the fluid between the first and second membrane . When pressure is applied to the first membrane , it will transmit pressure through the first nozzle , into the tube, via the second nozzle and into the second membrane in the adapters cylindrical compartment, hereby pressing the second piston rod ( attached after the second membrane in the adapter ) and pressing bone cement ( also contained in the adapter ) out of the adapter through a third nozzle - with a needle mounted - out into the bone needing repair cement during surgery .

The present invention distinctively separates itself from EP 1 614

403 Al by NOT using syringes , only using one piston to apply pressure , utilizing two non-flexable tubes for Transportation Fluid and Dose Fluid , a Clutch for connecting the two non-flexable tubes at each insides of the tubes , Transportation Fluid and Dose Fluid only separated by the Second Membrane - immediately after the Transportation Fluid and immediately before the Dose Fluid as well as the Second Membrane moves non-linear in the Second Tube . Moreover, the present invention seeks to compress and minimize all involved parts - and the entire solution - to a minimal size , whereas the invention described in EP 1 614 403 Al seek to use the 1 , 5 meter flexible tube to create distance between where the pressure is applied and the position of where the bone cement is discharged .

Description

The present invention utilize a known and used hydraulic technique invented and described by the french mathematician Blaise Pascal in 1653 and published in 1663. "Pascal ' s Law" ( aka "Pascal ' s Principle" or "The Principle of Transmission of Fluid Pressurization" ) is a principle in fluid dynamics saying, that a change in pressure at any time in a confined incompressible fluid will be transmitted throughout the whole fluid, so the change occurs everywhere in the confined fluid. The principle is referred to as "Pascal ' s Law" and is defined as : "Pressure, applied on a fluid in a confined container , transmits pressure equally and undminished to all parts of the container and working perpendicularly on to the enclosing surfaces" .

This principle is also used in a previous invention for cementing bones by percutan vertebrae plastics including 11 continous basic elements : A syringe ( cylindrical housing in plastic with a moveable piston rod attached to a rubber membrane ) with an end nozzle (with hole ) mounted on to a flexible tube of 1 , 5 meter in length , equal in diameter and larger than the nozzle diameter of the syringe that is mounted onto an adapters (plastic container as the syringe) nozzle at the other end of the tube (also larger diameter than the adapters nozzle with a hole) and the compartment of the adapter is closed by a second moveable membrane in order to compartmentalize the fluid between the first and second membrane. When pressure is applied to the first membrane, it will transmit pressure through the first nozzle, into the tube, via the second nozzle and on to the second membrane in the adapters cylindrical compartment, hereby pressing the second piston rod (attached after the second membrane in the adapter) pressing bone cement (also contained in the adapter) out of the adapter through a third nozzle - with a needle mounted - out into the bone needing bone cement during surgery.

The particulars obtained by this present invention in relation to the technical, standpoint is, that it enables to design dosing solutions (applicators) in arbitrary and compact shapes - made possible by Fluid Pressure Distribution (hydraulics) - hence shapes and designs (Figure 9; B, C, D, E) can be made without considerations for pistons, their working lengths and mechanical needs for long and linear solutions as demonstrated in Figure 9; A.

The present invention is based on 8 basic elements (Figure 1; Q) / (Figure 5; 1, 2, 3, 4, 5, 6, 7, 8) that together constitute a Dose Delivery Solution of fluid (in the following called 'Dose Fluid' (Figure 5; 6), based on connecting (Figure 5; 4) two non-flexable tubes ((Figure 5; 1, 7) made of ie. metal, glass or plastic) wherein the First Tube (Figure 5; 1) is in the first end closed with a First Membrane ( (Figure 5; 2) made of ie. rubber) onto which pressure can be manually applied and a Second Tube (Figure 5; 7) containing the Dose Fluid (Figure 5; 6), the Second Membrane ( (Figure 5; 5) made of ie. rubber) as well as a Hole (Figure 5; 8) where the Dose Fluid can escape (discharge). When the tubes are assembled with the Connector ( (Figure 5;

4) made of ie. rubber) the space in between the two membranes become one closed compartment, enabling the Transportation Fluid (Figure 5; 3) to move between the two tubes through the Connector - following the movement of the membranes accordingly ~ and keeping the Transportation Fluid volume constant. Figure 1's Area Q (marked with dashed lines) display the principal basic elements separated, Figure 1's Area X display how each side of the Connector interacts and Figure 1's Area Y demonstrate all basic elements principal correlation.

Figure 2's Area Y display the basic elements together and Figure 2's Area Z demonstrate the basic elements principle function with "Pascal's Law" after pressure has been applied (Figure 2; Z, 9). First Membrane (Figure 2; Z, 2) pushing the Tranportation Fluid (Figur 2; Z, 3, 91) onto the Dose Fluid (Figure 2; Y, 6, 92) discharged (Figure 2; Z, 61, 94) thoughout the Hole and the rest (Figure 2; Z, 6, 93) of the Dose Fluid remain in the Second Tube.

By using non-flexable tubes, following properties are primarily obtained; Minimizing the dosing errors (Figure 2; 61) affecting the accuracy, the entirety's stability (Figure 1; Q) and reinforce the longitudinal flow direction (Figure 1; 97) of the Transportation Fluid (Figure 1; 3) and the Dose Fluid (Figure 1; 6) .

The membranes primary functions are to divide the fluids without the loss of volume (sealing) exchange pressure and at the same time move longitudinally on the tubes insides, affected by the pressure applied by the First Membrane (Figure 1; 1). Thus is the volume of the moved Transportation Fluid (V_t ) = Volume of the discharged Dose Fluid (V_ad ) from the Second Tube demonstrated by Figure 2 , where the delivery solution display the system before (Figure 2; Y) and after applying pressure to the First Membrane (Figure 2; Z). The Connector (4) connects the First Tube’s and Second Tube's ends on their insides and lead the Transportation Fluid from the First Tube through the longitudinal Hole of the Connector over to the Second Tube and at the same time sealing the connection between the two non-flexible tubes ends . The Dose Fluid is the fluid the invention is made for accurately discharging ie. medicines for injection demanding high precision dosing, thus the materials involved are guided to ensure those properties. The Hole (8) from where the Dose Fluid is being discharged ensures the pressure stability - equlization - of the whole by releasing the pressure applied on the First Membrane ( Figure 2 ; Z ) .

The present inventions First Tube (Figure 3; 1) primary purpose is to contain the First Membrane (Figure 3; 2) and the Transportation Fluid (Figur 4; 3), where the first end has the First Membrane and designed to working length of the volume and longitudinal flow (Figur 3; 97) of the Transportation Fluid and in the other end mounted to the Connector (Figure 3; 4). The tubes are non-flexible to enforce a longitudinal flow and directing hydraulic forces from the First Membrane towards the Hole (Figure 3; 41, 46) of the Connector onto the Second Membrane (Figure 3; 7) and onto the Dose Fluid, that will discharge Dose Fluid volume by release through a hole at the end of the Second Tube and equalize the pressure applied from the First Membrane.

The First Tube can have arbitrary shapes in both longitidunal direction, width and girth in order to accomodate the whole design solution with the considerations of the functionality needs, especially the First Tube's need to employ the First Membrane, it's longitudinal movement and working lengths . The present inventions Connector's (Figure 3; 4) purpose is to connect to two non-flexible tubes, the First Tube (Figur 3; 1) and Second Tube (Figure 3; 7) and at the same time seal the assembly (Figure 3; 43, 45), despite the two tube ends do not have the same inner diameter, girth or shape (Figure 3; 72, 11) where they align, the Connectors shape and design will connect and seal the Transportation Fluid compartment between the two tubes with or without pressure being applied. The shape of the Hole (Figure 3; 41, 46) inside the Connector, providing the Transportation Fluid the ability to flow freely between the First Tube and Second Tube, can have different diameters, girth and shape along the longitudinal axis and the cross sections in one end (Figure 3; 46) and may differ from the cross section in the other end (Figure 3; 41) .

The present invention display a Connector where the Hole into (Figure 3; 46) the Connector is bigger going into the end from the First Tube than the hole in the other end (Figur 3; 41) exiting the Transportation Fluid into the Second Tube. This accomodates ie. filling of Transportation Fluid during assembly of tubes and Connector without loss of Transport Fluids in the process, since the assembly of the 8 basic elements is expected to be in the following orders a) First Tube connects to the Connector's first end; b) Transportation Fluid is to be filled into the First Tube; c) The Second Tube (containing the Second Membrane and Dose Fluid) is mounted to the other end of the Connector; d) The First Membrane is mounted into the first end of the First Tube pressing the Transportaion Fluid through the Connector and into the Second Tube and eventual air bubbles being pressed out at the First Membrane, thus encapsulating the Transportation Fluid and the Hole (Figur 3; 8) for the Dose Fluid can lastly be mounted.

The present invention's Second Tube (Figure 3; 7) contain both the Second Membrane ( Figure 3 ; 5 ) , Dose Fluid ( Figure 3 ; 6 ) and lastly the Hole ( Figure 3 ; 8 ) whereout the Dose Fluid will be discharged and the pressure applied at the First Membrane is equalized . The tube is non-flexable in order to direct the hydraulic flow longitudinally ( Figure 3 ; 97 ) from the First Membrane towards the Second Membrane and furtheron to the Dose Fluid, equalizing the pressure by discharging of Dose Fluid throughout the Hole . The Second Tube ' s inside is shaped to correspond with the Second Membrane in order for the Second membrane to move longitudinally and non-linear by the Transportation Fluid without compromising the sealing properties between the Transportation Fluid and the Dose Fluid. The Second Tube can in practice be an ampoule ( typically made of coated glass and sterile ) , typically cylindrical , linear in longitudinal direction and equal in diameter , girth and cross section enabling a mechanical piston to work with a cylindrical shaped membrane . The present invention enables a production of a non-linear ampoule . The Second Membrane can move non-linearly longitudinally without compromising the sealing abilities between the Transpotation Fluid and Dose Fluid.

The invention ' s functionality is demonstrated in practice by a MDA (Multi Dose Applicator ) for subcutanous injection of medicine whereas every figure ( Figure 6 , 7 , 8 ) describe the three states the invention go through to discharge an injected dose ( Figure 5 ; 61 ) . The previously mentioned Second Tube , Second Membrane and Dose Fluid are demonstrated with an existing ampoule containing 3 ml Dose Fluid equipped with an end cap with a rubber membrane onto where a needle can be mounted, perforate the rubber membrane and create the Hole ( 8 ) whereout the Dose Fluid can be released and discharged. On the First Tube - before the First Membrane - is a Dose Adj usting Mechanism mounted onto which a piston rod is connected ( Figure 6-8 ; 110 ) pushing the First Membrane . The Dose Adjusting Mechanism's design is not shown visually in detail, but the functionality will be reviewed through the illustration descriptions .

Figure 6 demonstrate the first step, where the Dose Adjusting Mechanism is set from the starting point (Figure 6; 95) to the desired position (dose (Figure 6; 96) ). This is done by twisting the Dose Adjusting Mechanism's Adjuster (Figure 6; 112) around the longitudinal axis (Figure 3; 97) whereby the Adjuster move upward and away from the starting point on an inner screw in the longitudinal direction - supported audiologically by a click sound for every second IU ( International Unit in medicines) and visually by a counter. The Adjuster is connected to a thread (Figure 5; 111) with a gearing, connected to a thread on a piston rod (Figure 5; 110) connected to the First Membrane, pushing the Adjuster back towards the starting point when pressure is applied manually on the Adjusters top button (Figur 8; 113). The Adjuster top button turns around the longitudinal axis freely with no correspondance to the Adjusters position.

Figure 7 demonstrate the second step where the Dose Adjusting Mechanism (Figure 7 ; 112) is adjusted to the desired position and dose. The Dose Adjusting Mechanism is 'loaded' in a new position (Figure 7; 95) and the piston rod is positioned the same as in Figure 6.

Figure 8 demonstrate the third and last step in the process of discharging the Dose Fluid, where the Adjuster is pressed back manually on the top button (Figure 8; 113) toward the starting point whereby the Adjuster, connected to an inner longitudinal thread, corresponds with the piston rod's thread and setting it in longitudinal motion, pressing the First Membrane, pressing the Tranportation Fluid through the Connector onto the Second Membrane, thus pressing the medicine (Dose Fluid (6)) through the hole of the needle (8) and hereby discharging the desired dose of medicine (Figure 8; 61) . The top button is pressed all the way back to the starting point (Figure 8; 95) (the original starting point (Figure 6; 95)) and the piston rod and the First Membrane have moved longitudinally to its new starting point (Figure 8; 95) due to the decrease in Dose Fluid volume.

The invention has hereby dosed and discharged medicine by the use of Fluid Pressure distribution (Figure 8; 94), the Transportation Fluid's constant volume (Figure 8; 3) and the medicine (Dose Fluid) volume left in the ampoule have now decreased (Figure 8; 93). The Dose Adjusting Mechanism and it's gearing of threads correspondance with the piston rod is necessary to ensure the precision of dosing (thus discharging) depending on the medicine types involved and their viscosity. Whereas the inventions piston rod (Figure 5; 98) press the First Membrane directly 1:1 (Figur 5; 9) it can be necessary to use gearing via threads in the Dose Adjusting Mechanism to ensure demands of precision.

The present invention enables better ergonomical Dosing Delivery Solutions as well as customizations in environments with non-linear demands, that are not utilized in existing solutions (Figur 9; A). Figure 9 display 5 different external design solutions, whereas the upper (Figur 9; A) is an existing solution with a mechanical piston and an existing glass ampoule of 3 ml dosing fluid.

The next 3 designs (Figure 9; B, C, D) are based on the same glass ampoule of 3 ml but utilize the present inventions technology and the design at the bottom of figure 9 (Figure 9; E) display utilization of all the present inventions technologies with a non-linear ampoule of 3 ml to ensure comparabilty between all the designs displayed in Figure 9. Especially the bottom design (Figure 9; E) emphasizes the difference of todays solutions (Figur 9; A) and how the present invention enables more compact solutions (Figure 9; E) exemplifying the improvement of carrying the applicator in a pocket.

FIGURE 1 - BASIC ELEMENTS SEPARATED AND ASSEMBLED

FIGURE 2 - BASIC ELEMENTS AND THEIR PRINCIPLE FUNCTIONS

FIGURE 3 - INVENTIONS BASIC ELEMENTS BEFORE ASSEMBLY

FIGURE 4 - INVENTIONS BASIC ELEMENTS ASSEMBLED BEFORE FUNCTION

FIGURE 5 - INVENTIONS BASIC ELEMENTS ASSEMBLED DURING AND AFTER FUNCTION

FIGURE 6 ~ EXAMPLE ; INJECTION SOLUTION WITH EXISTING AMPOULE - STEP 1

FIGURE 7 - EXAMPLE ; INJECTION SOLUTION WITH EXISTING AMPOULE ~ STEP 2

FIGURE 8 - EXAMPLE; INJECTION SOLUTION WITH EXISTING AMPOULE - STEP 3

FIGURE 9 - EXAMPLE ; DESIGNS

Summary of the figures

Figure 1 displaying the inventions principal basic elements separated ( Q) , their correspondence ( X) and basic elements assembled (Y) .

Figure 2 showing the inventions principal basic elements assembled before Dose Fluid is discharged (Y) , after Dose Fluid is discharged ( Z ) and how "Pascal ' s Law" is utilized between the basic elements .

Figure 3 display the inventions basic elements separated for both overview and indication of reciprocal design elements .

Figure 4 display the inventions basic elements assembled before discharge of Dose Fluid.

Figure 5 display the inventions basic elements assembled during discharging of Dose Fluid and their reciprocal functions .

Figure 6 show the inventions elements in the first of three steps before discharging of Dose Fluid demonstrated with a 3 ml existing ampoule in glass ( called Second Tube, Second Membrane, Dose Fluid and Hole ( needle ) ) including a Dose Adjusting Mechanism for precision dosing and pressuri zation . First step is an adjustment of the desired dose thus the ' loading ' and it ' s longitudinal working length .

Figure 7 display the inventions elements in the second of three steps before discharging of Dose Fluid. At second step the desired dose is adjusted, loading ready for manually adding pressure .

Figure 8 display the inventions elements in the third of three steps when discharging the Dose Fluid . At the third step, the top button of the Adjuster is pressed manually back to the starting position of the first step whereby pressure is transmitted to the piston, passed on to the First membrane, the Transportation Fluid, through the Connector, onto the Second Membrane pressing the Dose Fluid out of the Hole ( here a needle ) releasing and submitting the desired dose of Dose Fluid .

Figure 9 display the existing solution and present inventions capabilities in design of various MDA' s (Multi Dose Applicators ) based on standard cylindrical 3 ml ampoules and a custom ampoule of 3 ml .

Claims

Claim 1.

A device for dosing and discharging of fluid based on Fluid Pressure Distribution comprising 8 continous basic elements: A non-flexible First Tube (1), that does not change shape before, during or after function and pressurization containing a Transportation Fluid (3) closed in one end by a moveable First Membrane ( 2 ) and in the other end of First Tube mounted to a Connector (4) - with a hole in it's longitudinal direction (41) - attached to the inside of the First Tube connected to the non-flexible Second Tube's (7) first end with the Connector (4) - attached on the inside as on the First Tube - closed by a moveable Second Membrane (5) placed inside the Second Tube right after the Transportation Fluid and right before the Dose Fluid (6) . The Second Membrane is succeded by a Dose Fluid (6) and is completed with a Hole (8) at the second end of the Second Tube where the Dose Fluid can be released (91) and discharged. Pressure applied to the First Membrane (2) in the First Tube (1), distribute pressure onto the Transportation Fluid (3) flow through the Connector's (4) hole (41, 46), longitudinally connecting the First Tube's (1) second end and Second tube's (7) first end to the Second Membrane in the Second Tube adding pressure to the Dose fluid (6) equalizing the pressure applied by releasing and discharging the dose Fluid through the Hole (8) in the Second Tube's second end, C h a r a c t e r i z e d by the Connector ( 4 ) attached to the inner side of the First Tube (1) and the Second Tube (7) and the Second Membrane (5) stand alone is succeeded by the Dose Fluid (6) and completed in the end with a Hole ( 8 ) where the Dose Fluid can be released and equalize the pressure applied from the First Membrane (3).

Claim 2.

A device for dosing and discharging of fluid based on Fluid Pressure

Distribution, according to Claim 1, C h a r a c t e r i z e d by a non-flexable First Tube (1) to contain a First Membrane (2), Transportation Fluid (3) and attach a Connector (4). 1 basic element that can be variable in dimensions in both shape, girth, in cross sections and longitudinally to which a First Membrane can function (travel and seal) in the first end with another end enabling an attacment of a Connector ( 4 ) connecting a non-flexable Second Tube ( 7 ) .

Claim 3.

A device for dosing and discharging of fluid based on Fluid Pressure Distribution, according to Claim 1, C h a r a c t e r i z e d by a non-flexable Second Tube (7) to contain Transportation Fluid (3), a Second Membrane ( 5 ) , Dose Fluid ( 6 ) and attach a Connector ( 4 ) .

1 basic element that can be variable in dimensions in both shape, girth, in cross sections and longitudinally to which a Second Membrane can function (travel and seal) and in the first end enabling an attachment of a Connector (4) and a second end with a Hole (8) for discharching Dose Fluid.

Claim 4.

A device for dosing and discharging of fluid based on Fluid Pressure Distribution, according to Claim 1 and Claim 3, C h a r a c t e r i z e d by a Membrane (5) . 1 basic element in non-cylindrical shape to separate Transportation Fluid (3) and Dose Fluid (6) and be pushed by the pressure of the Transportation Fluid (3) in a non-linear longitudinal direction (97) and apply pressure on the Dose Fluid (6) .

Claim 5.

A device for dosing and discharging of fluid based on Fluid Pressure

Distribution, according to Claim 1, C h a r a c t e r i z e d by a

Connector ( 4 ) to connect two non-flexable tubes ( 1 , 7 ) , exchanging Transportation Fluid (3) . 1 continous basic element where the First End (42) is to be mounted and attached to the First Tubes second ends inside, the Second End (47) to be mounted and attached to the Second Tubes first end inside separated from the ends diameters by a larger diameter cross section part separating the non-flexible First Tube and non-flexible Second Tube from each other to seal and align with a longitudinal hole in the inside (41, 46) of the Connector (4) for Tranportation Fluid to flow through from the First Tube to the Second Tube .