Source: https://patents.google.com/patent/ES2277625T3/en
Timestamp: 2019-11-19 19:19:16
Document Index: 491377565

Matched Legal Cases: ['art 20', 'art 20', 'art 32', 'art 36', 'art 32', 'art 36', 'art 32', 'art 32', 'art 46', 'art 32', 'art 46', 'art 32', 'art 46', 'art 46', 'art 46', 'art 46', 'art 46', 'art 62', 'art 70', 'arts 62', 'art 66', 'art 70', 'art 70', 'art 62', 'arts 62', 'arts 70', 'art 86', 'art 86', 'art 32', 'art 40', 'art 40', 'art 40', 'art 86', 'art 62', 'art 70', 'art 66', 'art 70', 'art 62', 'art 62', 'art 70', 'art 62', 'arts 62', 'art 20', 'art 32', 'art 32', 'art 66', 'art 32', 'art 70', 'art 40', 'art 70', 'art 40', 'arts 88', 'art 70', 'art 62', 'art 66', 'art 86', 'art 70', 'art 62', 'art 46', 'art 40', 'art 40', 'art 0', 'arts 88', 'arts 88', 'art 70', 'art 70', 'art 40', 'art 40', 'art 40', 'art 40', 'art 40', 'art 20', 'art.\n7', 'art.\n9', 'art.\n13']

ES2277625T3 - Injection point without needle. - Google Patents
Injection point without needle. Download PDF
ES2277625T3
ES2277625T3 ES03005962T ES03005962T ES2277625T3 ES 2277625 T3 ES2277625 T3 ES 2277625T3 ES 03005962 T ES03005962 T ES 03005962T ES 03005962 T ES03005962 T ES 03005962T ES 2277625 T3 ES2277625 T3 ES 2277625T3
ES03005962T
2007-07-16 Publication of ES2277625T3 publication Critical patent/ES2277625T3/en
A needleless injection point (10a) comprising: a housing (16) defining a passage for fluids (56); a seal member (58) disposed inside the housing (16) and which includes a central opening (80) that can be opened and closed, whose seal member normally resides in a first position within the housing, in which the opening is closed; the sealing member being elastically deformable so that the application of a compressive pressure distally directed thereon facilitates the movement thereof within the housing to a second position, in which the opening opens and remains in communication with the passage of fluids; characterized in that within the fluid passage (56) of the housing a measuring member (102) is disposed that has a certain thickness and defines a fluid orifice (104) having a determined diameter, at least one of the thicknesses of the measuring member and the diameter of the fluid hole in order to regulate the fluid flow through the fluid passage (56).
Injection point without needle.
The present invention generally relates to medical techniques, and more particularly to an injection site without needle and fixed flow, to be used in applications intravenous infusion.
It is a common medical practice to introduce intravenously various liquids or medications in a glass blood of a patient (for example, a vein or an artery). Such Infusion is typically achieved by inserting a needle Hollow introducer in a target blood vessel. The needle introducer is liquidly connected to one end of a tube elongated flexible or liquid conduit, whose opposite end is liquidly connected to a solution bag. The solution bag itself typically is suspended over the patient with in order to allow gravity to facilitate the flow of liquid down the liquid conduit to the inside of the vessel blood of the patient through the introducer needle that remains operatively placed inside it. The tube or liquid conduit and solution bag are connected between yes by means of a measuring device that controls the volume of Infusion of liquid from the bag into the tube.
In many intravenous infusion devices, an injection point is found liquidly coupled to the duct of liquids in an intermediate position between the introducer needle and The solution bag. The injection point typically presents a "Y" shaped configuration and consists of a body part tubular main provided with a part of tubular lateral arm in Liquid communication with it. The distal end of the part of side arm is liquidly connected to the solution bag by middle of an upper segment of the duct or tube, the lower end of the main body part liquidly connected to the introducer needle by means of a lower segment of the tube. The upper end of the main body part is It is covered by a diaphragm that is typically made of rubber or a similar elastic material.
The inclusion of the injection point in the tube travel allows selective infusion of different medications in the patient's blood vessel by adding from them to the solution flowing from the solution bag towards the blood vessel through the upper tube segment, the injection point, lower segment of tube and needle introductory This additional infusion is typically carried out. by using a conventional syringe, whose needle pierce and pierce the diaphragm arranged on the end upper body of the injection site. Behind the expulsion of the medication from inside the syringe into the flow solution, the needle is removed from the main body of the point of injection, and the opening created in the diaphragm due to the passage of the needle through it is substantially closed after said extraction due to the elasticity of the diaphragm. As will be noted, the incorporation of the injection point in the conduction system of liquids allows the patient to administer various medications intravenously through the existing infusion device in the blood vessel, eliminating the need to submit the patient to additional needle pricks.
Although they provide certain benefits to patient, injection points constructed according to the state Prior to the technique, there are certain deficiencies that reduce their general utility As already explained, the use of these points Injection typically requires the syringe needle Conventionally traverses (i.e. pierce) the diaphragm subject to upper end of the main body part of the point of injection. However, the need to use a syringe provided with a needle to proceed with the introduction of the medication in the solution flow is undesirable, due to the risk of punctures of accidental needle.
Recognizing this deficiency, they have also developed in the prior art of injection points without needle that include a diaphragm adapted to assume open and closed configurations without inserting a needle. Although these needleless injection points eliminate the Need to pierce the diaphragm with a needle, also present certain deficiencies that reduce its general utility. The most One of the shortcomings of these deficiencies is the difficulty that comes with disinfection of the injection site, and in particular the diaphragm thereof, after the infusion of the medication in the same. In this regard, the diaphragm should be cleaned after each use of the injection point, the cleaning of which typically takes out by applying it to alcohol or an agent similar disinfectant However, due to the configuration of the diaphragm, it is often difficult to achieve disinfection complete and effective thereof, thereby increasing the risk of inadvertent introduction of contaminants into the solution flow in subsequent uses of the injection point.
US-A-5470319 reveals a needleless injection point that includes a member of hermetic closure that opens by means of a distal pressure directed and closes with the cessation of said pressure.
It is also a common medical practice to start a Intravenous infusion (I.V.) in a patient by using a IV infusion set In this regard, hospitals and the other medical centers typically attach an injection cap at the end of the intravenous infusion set, and then said intravenous infusion set and the attached injection cap They connect liquidly to a solution bag. Recently, the injection caps used together with infusion equipment Intravenous have been replaced by those of the needleless variant. The combination of intravenous infusion set (including a cap needleless injection), solution bag and tubes connection forms an intravenous drip unit.
The intravenous drip units that incorporate an injection point typically comprise a solution bag filled with fluids or an intravenous infusion bag that found suspended in a portable hanger assembly. A conduit Tubular fluid is connected liquidly to the bag solution and extends from it, and its distal end includes an introducer needle connected thereto, the point of injection connected liquidly with the liquid conduit. In These units, the fluid "drips" from the solution bag to the liquid conduit connected to it, being able to adjust the flow rate through the liquid conduit so control the flow rate at which the fluid is introduced in a path Anatomical of the patient. The bag is suspended well above the introducer needle level, so that the flow circulates through the liquid conduit by gravity.
To facilitate one more control or measurement Precise infusion rate of the therapeutic liquid in the patient, these intravenous drip units are equipped frequently of pumping equipment and / or control devices of the flow. Typically, the infusion rate is selected based on the type of therapy provided and the nature of the liquid therapeutic. The infusion flows commonly used are 83, 100, 125, 167, 200 and 250 ml / hour. However, as will be recognized, the need to incorporate a pumping equipment and / or a device for Flow control in the intravenous drip unit increases considerably the cost associated with it.
The invention is a needleless injection point as defined in claim 1, with a member measurer.
In a preferred embodiment, the housing defines a projection part dilated, elongated and proximal extension, which extends to and is coaxially aligned with the central opening. In addition to the projection part dilator, the housing defines an adapter part, elongated and distal extension, which extends away from the opening central. The adapter and dilator projection parts define jointly a continuous passage for fluids.
Arranged within the fluid passage of the dilating projection part there is a measuring member that defines a flow hole to regulate the flow of a liquid through the passage for fluids The measuring member is preferably sized with a thickness from about 1 mm to 10 mm, with the preferably sized hole with a diameter of approximately 300 microns The measuring member may consist of a separate element that is fixed inside the passage for fluids by means of an adhesive or other fixing procedure, or alternatively it can be formed as an integral part of the projection part dilator Additionally, the diameter of the hole and / or the thickness of the measuring member can be varied according to the flow rate of desired flow through it.
In addition to the housing, the injection point without needle consists of a sealing member that is arranged inside the central opening and the inner chamber of the housing. He hermetic closure member includes an elastically open Openable and closable arranged in it, and defines a deposit Expandable and contractable internal. The sealing member normally resides in a first position inside the housing in which the opening is in a closed configuration and the deposit is contracted. The sealing member is selectively deformable so that the application thereto of a distally directed pressure will make the same advance distally inside the housing to a second position, in which the tank is expanded and the opening assumes an open configuration and communicates with the passage of fluids and the Deposit. The cessation of pressure distally directed from the closure member induces the elastic return thereof to the first position, in which the opening recovers its closed configuration and The deposit is contracted. It is an important aspect that the Deposit shrinkage is adapted to prevent the creation of a vacuum inside the fluid passage when the closing member Airtight returns elastically to its first position.
The sealing member further comprises an elastic body that includes a distal end, an end proximal equipped with inner and outer surfaces, and an opening that extends between the inner and outer surfaces of the proximal end The proximal end is defined by one part Proximal body generally cylindrical, with the distal end defined by a distal part of the generally cylindrical body and endowed with a diameter greater than that of the proximal part. Conformed between the proximal and distal parts of the body there is a medial part generally cylindrical endowed with a diameter that is larger than that of the proximal part but smaller than the diameter of the distal part. The transition between the medial part and the distal and proximal parts is defined by a pair of inclined flanges. Inner surface of the proximal end of the body preferably has a generally hemispherical configuration, with the opening extending axially between the outer end surface proximal and the apex of its hemispherical inner surface.
Arranged inside the body there is a spring of radial sheets that includes a plurality of sheet portions with elongated grooves extending between them. Leaf parts are adapted to radially inwardly apply a deforming force on the proximal end of the body that maintains the opening in its closed configuration when none is applied distally directed pressure on the outer surface of the proximal end The reservoir of the seal member is defined between the radial leaf spring and the body, with the slots defining channels for the flow of liquid between the opening and reservoir when the closing member travels to its second position, and between the reservoir and the fluid passage during the return of the closing member to its first position.
The closing member further comprises a spring toric elongated and generally cylindrical, equipped with a first end that rests against the distal end of the body, a second end and a perforation that extends longitudinally through of the same. In the preferred embodiment, the spring Toric has a ribbed configuration and includes elongated channels which extend longitudinally along the outer surface of the same. When the closing member is in his first position, an inclined shoulder of the body and the second end of the O-ring lean against the housing. In this respect, the toric spring is preferably sized so that it apply a slight compressive force to it (i.e. preload) when the closing member is in its first position. Both the body and the O-ring of the closure member are preferably made of silicone, although at the point of Injection of the present invention can also be used similar alternative materials.
The dilating projection part of the housing extends inside the sealing member, and more particularly extends through the piercing of the spring toric and even the radial leaf spring. In this respect, the body further defines an annular flange that extends radially inwards from the distal end thereof and rests against the dilating projection part of the housing when the it is extended through drilling and in the member of closure, thus creating a tight seal between them. The application of distally directed pressure on the surface outside the proximal end of the body causes the spring to radial blades advance distally on the projection part dilator The resulting outward bending of the parts of blade facilitates radial expansion of the opening to its open configuration. Said bending towards the outside of the parts Blade is assisted by ramp parts formed in the interior surfaces thereof, which fit with the part of dilating projection when the closure member is distally displaced on it. Additionally, the movement of the member closing towards its second position facilitates the expansion of the deposit from your normally contracted state.
Conversely, the cessation of pressure distally directed from the outer surface of the proximal end makes the radial leaf spring is proximally removed from above The dilating projection part. Said proximal displacement facilitates the elastic return of the opening to its configuration closed, and tank compression. When the closing member it is moved to its second position, the toric spring is compressed between the distal end of the body and the housing. In this way, the movement of the closing member back to its first position is facilitated by the elastic return of the toric spring to its normal configuration, slightly compressed.
It is an important aspect that when the member closing is distally moved to its second position, the intravenous fluid introduced into it through the opening open flows to the expanded reservoir through the slots defined between the radial leaf portions of the leaf spring Radial In addition to flowing into the reservoir, said liquid flows directly towards the passage for fluids. When the closing member elastically returns to its first position, the resulting compression of the reservoir expels the liquid from within back between the grooves defined between the leaf parts radial and towards the passage for fluids, thus creating a displacement null or positive inside it, that is, preventing a vacuum is created in the fluid passage. In the example of preferred embodiment, the reservoir is sized so that move approximately 0.035 ml of volume of retained liquid. In In this respect, the volumetric capacity of the tank is preference equal to or greater than the inside diameter of the passage for fluids multiplied by the axial travel distance of the member closing when it moves from its first position to its second position.
The housing of the present injection point preferably consists of a top section that defines the opening central and a lower section that is attached to the upper section. When they are joined together, the upper and lower sections jointly define the inner chamber. The upper section of the housing preferably has a color code according to the size of the hole in the closure member, ie the predetermined flow rate of fluid that is obtained by using the injection point without needle as part of the intravenous drip unit. The section lower part preferably comprises a central part which is attached to the upper section by means of a weld sonic, and includes the dilating projection part that extends proximally from one side of it and the adapter part that is extends distally from the opposite side of it. The part adapter of the lower section preferably comprises a tube connection equipped with a conical outer surface and a blunt distal tip. Slidably extensible over the connection of tube and frictionally retainable on it there is a lid respirator The lower section also includes a region of distal block surrounding the adapter part and preferably includes a plurality of Luer threads formed inside the same.
All of these, as well as other features of The present invention will become more apparent by reference. to the illustrations, in which:
Figure 1 is a perspective view that illustrates by way of example a way in which the injection point no needle is used to facilitate the infusion of liquids in a anatomical pathway;
Figure 2 is a side section view Partial of a needleless injection point that can be adapted as exemplary embodiment of the present invention;
Figure 3 is a side sectional view of the needleless injection point illustrated in Figure 2, where shows the sealing member thereof in a first closed position or position;
Figure 4 is a side sectional view of the sealing member illustrated in Figure 2, in which shows said deformed seal member in its second open position or position;
Figure 5 is an exploded illustrating the components consisting of the illustrated sealing member in Figures 3 and 4; Y
Figure 6 is a side section view Partial injection point without fixed flow needle built according to a preferred embodiment example of the present invention.
With reference to the figures, which are exposed solely for the purpose of illustrating preferred embodiments of the present invention, and not for the purpose of limiting them, the Figure 1 illustrates a needleless injection point 10 used for facilitate the infusion of a medicine into a blood vessel (by example, a vein or artery) of a patient. How will it be exposed then in more detail, the needleless injection point 10 of the preferred embodiment has advantages over constructed according to the prior state of the art, while the itself is specifically adapted to create a displacement of null or positive fluid inside the liquid conduit 12 extending from injection point 10 to the vessel blood of the patient when a needleless introducer 14 is removed from within. It is an important aspect that said zero or positive fluid displacement prevents the formation of a vacuum inside the liquid conduit 12, thus eliminating any backflow of blood inside. As will be noted, any blood reflux into the fluid conduit 12 is extremely undesirable, while coagulation can obstruct the liquid conduit 12 or create a clot that passes inadvertently to the patient's blood vessel.
With reference to the Figures 2-5, the injection point 10, which can be adapted as described below with reference to Figure 6 as exemplary embodiment of the present invention consists of a hollow housing 16. Housing 16 itself consists of an upper section 18 defining a proximal part 20 of reduced diameter provided with Luer threads 22 formed on the outer surface thereof. In addition to the upper section 18, the housing 16 includes a section lower 24 which is rigidly attached to the upper section 18. When joined together, the upper and lower sections 18, 24 together define an inner chamber 26. In this regard, the proximal part 20 of the upper section 18 defines an opening central 28 that communicates with the inner chamber 26. As can be seen better in Figures 3 and 4, the transition between the central opening 28 and the inner chamber 26 is defined by an annular shoulder inclined 30 formed on the inner surface of the section top 18.
The lower section 24 of the housing 16 consists of a central part 32 defining a proximal surface 34 of circular and generally planar configuration that is surrounded by an annular flange part 36. Formed on the outer surface of the central part 32 and extending therefrom there is a flange annular continuous 38. When the upper and lower sections 18, 24 are joined together, the distal edge of the upper section 18 is rests against flange 38, with flange part 36 extending along the inner surface of the upper section 18 in direct contact with it. The union of the upper sections e lower 18, 24 each other is preferably provided by a sonic welding between the distal edge of upper section 18 and the flange 38 defined by the lower section 24. However, the people with an ordinary knowledge of the technique will notice that at the injection point 10 joining methods can be used alternatives, such as the use of adhesives. The upper sections e lower 18, 24 are sized in such a way that when they are rigidly attached to each other in the manner indicated, the outer surface of upper section 18 is substantially flush with the outer surface of the central part 32 of the bottom section 24.
Extending proximally from the surface proximal 34 of the central part 32 in relation substantially perpendicular to it there is an elongated projection part dilator 40 that is coaxially aligned with the opening center 28 of the upper section 18. The projection part dilator 40 has a generally cylindrical configuration and defines a blunt proximal tip 42. In addition to the projection part dilator 40, there is an elongated adapter part 46 formed in the lower section 24 extending distally from the surface distal 44 of the central part 32 thereof. At the point of injection 10 the adapter part 46 preferably comprises a tube connection that defines a conical outer surface or tapered and a distal tip blunt 48. Also extending distally from the distal surface 44 of the central part 32 there are a distal fixation region 50 surrounding the adapter part 46 and it is used to facilitate the connection of the housing 16 to a annular surface In the preferred embodiment, the distal fixation region 50 includes Luer threads 52 formed in its inner surface, and is sized so that the tip distal 48 of adapter part 46 protrudes beyond the edge distal of it.
As noted in Figure 4, the part adapter 46 is configured to facilitate connection of the point injection 10 to the liquid conduit 12. Said connection is achieved by advancing the adapter part 46 through one end of the light of the conduit for liquids 12, the adapter part 46 being dimensioned and configured so that it remains frictionally retained inside the duct. It will warn that the distal fixation region 50 can be used to connect injection point 10 with other infusion components other than of the liquid conduit 12. When the adapter part 46 is not used to facilitate the connection of the injection point 10 with the 12 liquid conduit or other infusion components, typically said part is covered by a breathing cap 54 which presents a complementary configuration that moves over the same and is frictionally retained, as seen in Figure 2. An important aspect is that the dilator projection parts and adapter 40, 46 of lower section 24 jointly define an elongated fluid passage 56, which extends through the bottom section 24 and is coaxially aligned with the opening center 28 of the upper section 18.
With reference to the Figures 3-5, the injection point 10 also comprises a seal member 58 which is disposed within the central opening 28 and the inner chamber 26 of the housing 16. The sealing member 58 consists of an elastic body 60 with a generally cylindrical proximal part 62 defining an end proximal 64, and a generally cylindrical distal portion 66 that defines a distal end 68. Arranged between the proximal and distal 62, 66 there is a medial part 70 of cylindrical configuration. The proximal, medial and distal parts 62, 70, 66 are of diameters progressively increasing, with the diameter of the distal part 66 greater than that of the medial part 70 and the diameter of the medial part 70 greater than that of the proximal part 62. The transition between proximal and medial parts 62, 70 is defined by a first flange inclined 72, and the transition between the medial and distal parts 70, 66 is defined by a second inclined flange 74.
The proximal end 64 of the body 60 defines a outer surface 76 sunken and circular configuration, which It presents a generally planar configuration. Besides the outer surface 76, the proximal end 64 defines a surface interior 78 generally hemispherical. Extending axially to through the proximal end 64 from the outer surface 76 to the apex of the inner surface 78 is an opening 80. Additionally, formed around the distal end 68 of the body 60 and extending radially inward from it, there are a continuous annular flange 82, whose inner peripheral edge defines a thickened gasket. The body 60 is preferably made of silicone, although alternatively it could manufactured with another material of similar elasticity, such as rubber.
The closing member also comprises a spring of radial blades 84 which is arranged inside the body 60. The radial leaf spring 84 consists of a base part 86 generally cylindrical, consisting of three (3) parts of sheet 88 identically configured and equidistant from each other shaped on an inclined flange 90. The blade portions 88 are separated from one another by means of three (3) longitudinal grooves 92 that are extend to flange 90. Arranged on the respective inner surface of each of the leaf portions 88 there are some 94 general wedge-shaped ramps, whose usefulness will be exposed Then in more detail.
As best noted in Figures 3 and 4, the radial leaf spring 84 is disposed within the body 60 of such that the outer ends of the blade portions 88 are received in an annular canal that surrounds the inner surface hemispherical 78 of the proximal end 64. Additionally, the part distal 66 of body 60 wraps the base part 86 of the spring of radial blades 84 so that tab 82 extends over the inner surface of it. The radial leaf spring 84 It is preferably manufactured with polysulfone or polycarbonate, although similar materials can be used as an alternative rigid with memory.
In addition to body 60 and leaf spring radial 84, the seal member 58 of the point of injection 10 consists of an elongated axial toric spring 96 and generally cylindrical, which has a ribbed outer surface and includes a perforation 98 that extends longitudinally (it is say, axially) through it. As will be discussed later with more detail, the toric spring 96 defines a first end or end proximal that normally rests against the distal end 68 of the body 60, and a second end or distal end that is normally rests against the housing 16, in particular against the surface proximal 34 of the central part 32 of the lower section 24. As the body 60, the toric spring 96 is preferably manufactured with silicone, although alternatively it can be manufactured with another material of similar elasticity, like rubber.
At the injection point 10, the opening 80 that extends through the proximal end 64 of the body 60 is elastically open and closable. In this regard, the member of airtight closure 58 of the injection point 10 normally resides in a first position inside the housing 16 (as shown in the Figure 3), with the opening 80 in a closed configuration. Is a important aspect that the seal member 58 is selectively deformable so that the application of a pressure distally directed on it, and in particular on the raised edge surrounding the outer surface 76 of the end proximal 64, will make the same advance distally inside the housing 16 to a second position (illustrated in Figure 4) in which the opening 80 adopts an open configuration. How I know will expose later in more detail, due to the elasticity of the sealing member 58, and in particular of the O-ring 96 thereof, the cessation of the pressure distally directed from the proximal end 64 will make the seal member 58 return elastically to its first position, in which the opening 80 adopts the closed configuration again.
When the seal member 58 is arranged in its normal position or first position within the housing 16, the dilator projection part 40 of the section bottom 24 extends through the piercing 98 of the spring toric 96 and is inserted into the hollow interior of the leaf spring radial 84. In this respect, the proximal tip 42 of the part of dilator projection 40 extends approximately to the inclined flange 90 of the radial leaf spring 84. When extends through the radial leaf spring 84, the projection part dilator 40 passes through the opening defined by the flange ring 82 of body 60, and in particular the thickened shoulder defined in it. It is an important aspect that the diameter of the opening defined by said projection is smaller than the diameter exterior of dilator projection part 40. In this way, when the dilator projection part 40 passes through this opening, the projection is tightly tight against the outer surface of it, that is, the projection is compressed between the outer surface of the projection part dilator 40 and the inner surface of the base part 86 of the radial leaf spring 84.
Additionally, when the closing member airtight 58 is in its first position, both the proximal part 62 as the medial part 70 of the body 60 reside within the opening center 28 of the upper section 18, and the second inclined flange 74 and the distal part 66 of the body 60, as well as the O-ring 96, reside within the inner chamber 26 of the housing 16. It is a important aspect that, although the diameter of the medial part 70 of the body 60 is larger than the diameter of the proximal part 62 of the same, both the proximal part 62 and the medial part 70 are they extend along the leaf portions 88 and cover their surface outside when the closure member 58 is in its first position. In this respect, because the medial part 62 is arranged inside the central opening 28, it is contracted (it is ie compressed) against the outer surfaces of the parts of leaf 88, with which the first inclined flange is flattened 72 normally defined between the proximal and medial parts 62, 70. When the seal member 58 is in its first position, the second inclined flange 74 of the body 64 extends along and covers the flange 90 of the radial leaf spring 84, and it is compressed between the flange 90 and the inclined flange 30 formed on the inner surface of the upper section 18. Additionally, the proximal end 64 of the body 60 protrudes slightly beyond the edge of the proximal part 20 of the section upper 18, as best noted in Figures 2 and 3.
As already indicated, the proximal end of the toric spring 96 rests against the distal end 68 of the body 60, while the distal end of the toric spring 96 rests against the central part 32 of the lower section 24, and in particular the proximal surface 34 thereof. It is an aspect important that, at the injection point 10, the distance that separates the flange 30 of the proximal surface 34 of the central part 32 slightly exceeds the combined length of the distal part 66 of the body 60 and the toric spring 96. Thus, when the closure member Hermetic 58 is disposed in its first position within the housing 16, the O-ring 96 is slightly compressed between the distal end 68 of the body 60 and the proximal surface 34 of the central part 32, which applies to it a preload that makes it bulges slightly outward as shown in Figure 3. Due to the application of the preload, the spring Toric 96 is operable to push the medial part 70 of the body 60 up and into the central opening 28, which causes the contraction of it in the manner already indicated and facilitates the compression of the second inclined flange 74 between the flanges 30, 90. It is an important aspect that, when the member of Hermetic seal 58 is in its first position, the parts of leaf 88 of the radial leaf spring 84 apply a force deformator directed radially inward over the end proximal 64 of body 60 that holds the opening 80 in its closed configuration.
As Figure 4 shows, the application of a pressure distally directed to proximal end 64 of body 60 by an infusion component such as tip 15 of the introducer 14 causes the radial leaf spring 84 to move distally on the dilator projection part 40. Said displacement separates the inclined flange 74 from the body 60 of its adjacent contact with flange 30, and further pushes the medial part 70 of body 60 from inside the central opening 28. Additionally, this distal displacement facilitates compression of the toric spring 96, causing it to bulge into the inner chamber 26 of the housing 16. It is an important aspect that the cam action of the dilating projection part 40 against the leaf parts 88, and in particular the ramps 94 formed in the interior surfaces thereof, makes it flex outward thus facilitating radial expansion of the opening 80 towards its open configuration.
Additionally, since the medial part 70 of the body 60 is removed from the interior in the constriction phase of the central opening 28 of the upper section 18, it returns elastically to its normal orientation (illustrated in Figure 5), thus forming the first inclined flange 72 and defining a reservoir expandable and contractable 100 between the inner surface of the part medial 70 and the outer surfaces of the leaf portions 88 and of the flange 90 of the radial leaf spring 84. Thus, when the seal member 58 moves to its second position as shown in Figure 4, the proximal part 62 of the body 60 extends along and covers the outer surfaces of the leaf portions 88, with the distal part 66 extending along and covering the base part 86 of the radial leaf spring 84. Without However, the medial part 70 of the body 60 is separated from the outer surfaces of the leaf portions 88, thus defining the tank 100. In this respect, only the proximal part 62 of the body 60 resides within the central opening 28, while the parts medial and distal 70, 66 of body 60 and toric spring 96 Fully compressed reside inside the inner chamber 26.
When the seal member 58 of the injection point 10 moves to its second position as it shown in Figure 4, the open opening 80 communicates simultaneously with the passage of fluids 56 and the reservoir 100. In particular, the opening 80 open is coaxially aligned with the fluid passage 56, thereby creating a continuous channel between the introducer 14, the fluid passage 56 and the infusion component (such as the conduit for liquids 12) to which the adapter part 46 is connected. opening 80 open communicates fluidly with the tank 100 a through the grooves 92 that extend between the leaf portions 88 of the radial leaf spring 84. In this way, a medicament dispensed from the introducer 14 flows through the open opening 80 and it reaches the passage for fluids 56 and the tank 100. It is an aspect important that the medication provided by the introducer 14 be given prevents seepage into the inner chamber 26 thanks to the tightness created by the support of tip 15 of introducer 14 against the raised edge surrounding the outer surface 76 of the end proximal 64, and the tightness created by the compression of the tab 82 between dilator projection part 40 and the part of base 86 of the radial leaf spring 84. As will be noted, the waterproof closure created by tab 52 is a sliding closure that travels longitudinally along the projection part dilator 40 while the seal member 58 moves to Your second position.
Due to the elasticity of the toric spring 96, cessation of pressure distally directed from the proximal end 64 causes the radial leaf spring 84 to be removed proximally from above the dilator projection part 40, thus facilitating the elastic return of the seal member 58 to its first position, as shown in Figure 3. The return of the member of airtight closure 58 to its first position causes the opening 80 return elastically to its closed configuration. Further, while the seal member 58 moves towards its first position, the resulting forced displacement of the medial part 0 from body 60 towards the central opening 28 facilitates contraction of deposit 100, since, as already indicated, the part medial 70 is compressed against the outer surfaces of the sheet parts 88 when the seal member 58 is located in his first position. It is an important aspect that this shrinkage of the reservoir 100 causes the liquid previously introduced in it be expelled from its interior towards the passage of fluids 56 through slots 92 that extend between the leaf parts 88 of the radial leaf spring 84. The advantages derived from this resulting flow of liquid into the passage to fluids 56 during return of the sealing member 58 a Your first position is set forth below.
As already indicated, in the points of needleless injection according to the prior art there is a tendency for blood to be drawn into the duct to fluids that enter the anatomical pathway when the injection point introducer. This blood reflux is consequence of the vacuum that is created in the liquid conduit at remove the introducer from the injection point according to the state prior art. The contraction of the deposit 100 of the point of injection 10 in the manner already indicated advantageously prevents creation of a vacuum in the conduit for liquids 12 when the sealing member 58 moves from its second position (illustrated in Figure 4) to its first position (illustrated in the Figure 3). In this regard, the flow of liquid from the reservoir 100 towards the passage of fluids 56 creates a null or positive pressure in the fluid passage 56 and the liquid conduit 12 coupled to the same, thus preventing the aspiration of blood inside. The absence of blood in the fluid conduit 12 prevents advantageously any unwanted coagulation inside the same and eliminates the risk of inadvertent duct obstruction for liquids 12.
At the injection point 10, the tank 100 It is sized to displace an equal volume of liquid or greater than the product of the average internal diameter of the passage of fluids 56 extending through the projection part dilator 40 and the axial travel distance of the member of Hermetic closure 58 between its first and second positions. For the most applications, expanded tank 100 is dimensioned so that it has a volumetric capacity of approximately 0.035 ml which is sufficient to facilitate a zero or positive pressure inside the fluid passage 56 when the sealing member 58 returns to its first position. It will be noted that increasing the diameter of the medial part 70 of the body 60 facilitates a consequent increase in capacity volumetric deposit 100. In this regard, an increase in the tank volume 100 causes a positive pressure to be created in the fluid passage 56 when the tank 100 is contracted. Conversely, the diameter of the medial part 70 can be reduced by so that the volume of the tank 100 causes a pressure to form zero (zero pressure) in the fluid passage 56 when the tank 100 is contracted
As already indicated, the injection point 10 shown in Figures 2-4, and in particular the housing 16 thereof, is adapted for easy connection liquid with the liquid conduit 12. Although not illustrated, it notice that the housing 16 can be configured to be connected also to other infusion components. In this respect, they can other injection points that include the member of hermetic closure 58 incorporated in a different housing configuration without leaving the scope of the present invention. From in fact, any housing with which the closure member is used airtight 58 only needs to be configured so that the member of Hermetic closure 58 is movable between its first and its second position to create the fluid passage from introducer 14 to the inside of the infusion component as previously described.
Due to the configuration of the closing member airtight 58, in an emergency situation a medication in the fluid passage 56 by means of a device needle introducer instead of needleless introducer 14 previously described. In this regard, when using a introducer device provided with needle, the closure member Airtight 58 will not move to its second position to facilitate the opening 80 is opened. Instead, the force is simply forced needle of the introducer device provided with a needle through the opening 80 closed to the interior of the fluid passage 56 of the dilating projection part 40.
With reference to Figure 6, it shows a fixed flow needleless injection point 10a constructed according to a preferred embodiment of the present invention. He injection point 10a is substantially similar in construction and operation to the injection point 10 previously described. Without However, the injection point 10a is further adapted for supply a fixed flow rate of a therapeutic liquid through the same when it is liquidly connected in a drip system intravenous.
As illustrated in Figure 6, the point of injection 10a is structurally identical to injection point 10 previously described, except that a measuring member is provided annular 102 within the proximal end of the projection part dilator 40a of injection point 10a. More particularly, the measuring member 102 resides inside the proximal end of the fluid passage 56a of the dilator projection part 40a. He measuring member 102 defines proximal and distal surfaces, with the proximal surface substantially flush with the proximal end of the dilating projection part 40a, and the distal surface leaning against an annular flange formed on the inner surface of the dilating projection part 40a defining the step for 56a fluids. The preferred thickness of the measuring member (i.e., the distance that separates the proximal and distal surfaces of it) is from about 1 mm to 10 mm.
Centrally positioned on the measuring member 102 and extending axially therethrough is a hole 104. Hole 104 has a preferred diameter of approximately 300 microns, although other sizes thereof, as well as other thicknesses of the measuring member 102, are also contemplated here for reasons that will be exposed in more detail. The measuring member 102 may consist of a separate element that is fixed in the fluid passage 56a by means of an adhesive or other fixing procedure, or alternatively it can be an integral part of the part of dilator projection 40a.
When the seal member 58 of the injection point 10a is moved to its second position as shown in Figure 6, the open opening 80 communicates liquidly with the fluid passage 56a of the dilating projection part 40a through the hole 104 of the measuring member 102. Of this way, the measuring member 102, and in particular the hole 104 of the It controls the flow with which a liquid can flow to the passage for fluids 56a and, consequently, through the point of 10a injection As will be noted, the liquid flow rate at through the measuring member 102 can be modified by changing the hole diameter 104 and / or the thickness of the measuring member 102. In in this regard, it is contemplated that at the injection point 10a they can incorporate measuring members 102 of different thicknesses and / or that include holes 104 of different diameters, depending on the flow rate of liquid flow that you want to get in it. It also contemplates that the upper section 18 of the housing 16 can be made in one color among a wide variety of colors different, where each particular color would correspond to a measuring member 102 of a particular size, and therefore at a determined liquid flow rate that can be obtained through the injection point 10a.
As also illustrated in Figure 6, when the injection point 10a is to be used as a device for control the flow rate, typically a Luer connector is used 106 to facilitate connection of one end of a tubular conduit of liquids with the housing 16, the opposite end of said liquid conduit connected to a solution bag. The connector Luer 106 consists of a fastening section 108 provided with threads internal fittings with the external threads of the proximal part 20 of the upper section 18. In addition to the fixing section 108, the Luer connector 106 consists of a conical tip section 110 which, when the fixing section 108 is fitted with the section upper 18, is adapted to facilitate distal displacement of the seal member 58 of the injection point 10a from Your first position to your second position.
Other modifications and additional improvements They may also be obvious to people who are experts in technique. Thus, the particular combination of parts described and illustrated in this document is only intended to represent an example of embodiment of the present invention, and is not intended to serve as limitation of other alternative devices within the scope of the invention.
1. A needleless injection point (10a) that understands:
a housing (16) defining a passage for fluids (56);
a seal member (58) arranged in the inside of the housing (16) and that includes a central opening (80) openable and closable, whose sealing member resides normally in a first position inside the housing, in which the opening is closed;
being the sealing member elastically deformable so that the application of a pressure distally directed compression on it facilitate the displacement of the same inside the housing to a second position, in which the opening opens and communicates with the passage of fluids;
characterized in that within the fluid passage (56) of the housing a measuring member (102) is disposed that has a certain thickness and defines a fluid orifice (104) having a determined diameter, at least one of the thicknesses of the measuring member and the diameter of the fluid hole in order to regulate the fluid flow through the fluid passage (56).
2. The injection point of claim 1, wherein said seal member (58) further defines a Internal tank (100) expandable and contractable, which is adapted to retain a volume of liquid when it is expanded and contracts when the sealing member is in its first position, and displacement of the sealing member to the second position causes the tank to expand so that the open opening communicate with it, with the closing member airtight cooperatively fitted with the housing so that the contraction of the deposit that occurs when the closing member tightly returns elastically to the first position pushes any volume of liquid retained inside the reservoir towards the fluid passage in order to prevent the creation of a vacuum in its inside.
3. The injection point of claim 2, in which the fluid passage (56) has an internal diameter and the tank (100), when expanded, has a capacity volumetric which is not less than the product of the internal diameter of the fluid flow through the distal displacement distance of sealing member (58) from the first position to the second position.
4. The injection point of claim 3, in which the volumetric capacity of the expanded tank (100) is of approximately 0.035 ml.
5. The injection point of any of the preceding claims, wherein said closure member airtight (58) comprises:
an elastic body (60) having an end distal and a proximal end that defines inner surfaces and outside, and where said opening extends through the end proximal between the inner and outer surfaces thereof;
a radial leaf spring (84) arranged within said body and adapted to apply a force deformator directed radially inward over the end proximal, which normally keeps the opening in its configuration closed when no distally directed pressure is applied on the outer surface of the proximal end; Y
an elongated O-ring spring (96) provided with a first end that rests against the distal end of the body (60) elastic, a second end and a perforation that extends longitudinally through it;
extending said projection part dilator through the drilling of the toric spring until the inside of the radial leaf spring, so that the application of distally directed pressure on the outer surface of the proximal end causes the radial leaf spring to move distally on the dilating projection part, which facilitates radial expansion of the opening to its open configuration, and cessation of distally directed pressure on the surface outside causes the radial leaf spring to be removed proximally from its position on the projection part dilator, which facilitates the return of the opening to your closed configuration.
6. The injection point of claim 5, wherein said elastic body (60) comprises:
a proximal part (62) generally cylindrical defining said proximal end;
a distal part (66) generally cylindrical defining said distal end;
a medial part (70) generally cylindrical formed between the proximal and distal parts;
a first inclined flange (72) formed between the medial and proximal parts; Y
a second inclined flange (74) formed between the medial and distal parts;
where the diameter of said medial part is greater that the diameter of said proximal part and smaller than the diameter of said distal part.
7. The injection point of claim 6, in which the second end of the toric spring (96) and the second inclined flange (74) of the body rest against the housing when the sealing member is in the first position, and the O-ring is sized so that it is compressed between the distal end of the body and the housing when the member of Hermetic seal is in the first position, so that it apply a preload to the toric spring.
8. The injection point of claim 5, 6 or 7, in which said elastic body (60) includes a flange annular (82) formed around the distal end thereof and extending radially inward, forming a tight seal against said dilating projection part.
9. The injection point of any of the claims 5 to 8, wherein said elastic body (60) and said toric spring (96) are made of silicone.
10. The injection point of any of the claims 5 to 9, wherein the inner surface of the proximal end (78) presents a configuration generally hemispherical and said opening extends axially between the outer surface and the apex of the inner surface.
11. The injection point of any of the claims 5 to 10, wherein said radial leaf spring (84) comprises a plurality of leaf portions (88) with grooves (92) between them, said leaf parts apply a force deformator directed radially inward over the end proximal elastic body that holds the opening in its closed configuration, and said slots define channels for the fluid flow between the opening and the reservoir when the member airtight seal moves to the second position, and between the reservoir and fluid flow during the return of the member of Close to the first position.
12. The injection point of the claim 11, in which each of the sheet parts (88) includes a interior surface provided with a ramp part (94) formed on it to assist radial expansion of the opening towards the open configuration when the seal member move distally over the dilating projection part.
13. The injection point of the claim 1, in which said housing defines an outer surface with Luer threads formed therein around the passage for fluids
14. The injection point of claim 1, in which said housing further defines an adapter part (46) elongate that extends distally, defining said part of dilating projection and said adapter part the passage for fluids jointly.
15. The injection point of claim 14, in which the adapter part (46) of the housing comprises a tubular connection with a tapered outer surface and a tip distal rome (48).
16. The injection point of any of the preceding claims, wherein said housing further defines a distal fixation region (52) to facilitate connection of the housing to an annular surface.
17. The injection point of claim 16, wherein said fixing region includes a plurality of Luer threads (52) inside it.
18. The injection point of claim 14 or 15, in which said housing comprises:
an upper section (18) defining said central opening; Y
a lower section (24) attached to said section superior and comprising:
a central part (32); a projection part dilator (40) extending proximally from the part central, and an adapter part (46) that extends distally from the central part;
where said upper and lower sections jointly define the inner chamber when the at each other.
19. The injection point of claim 18, in which the seal member (58) leans against and it is compressed between the central part (32) of the lower section and the upper section (18) of the housing when the closure member It is in the first position.
20. The injection point of claim 18 or 19, in which the adapter part (46) comprises a connection for tubes with a tapered outer surface and a tip distal Rome, and the lower section further defines a region of distal fixation that wraps the adapter part to facilitate connection of the housing to an annular surface.
21. The injection point of claim 18, 19 or 20, in which the upper section (18) of the housing has a color code depending on the size of the hole (104) inside of the measuring member.
22. The injection point of any of the preceding claims, wherein the measuring member (102) It has a thickness between approximately 1 mm and 10 mm.
23. The injection point of any of the preceding claims, wherein the hole (104) has a diameter of approximately 300 microns.
ES03005962T 1994-06-20 1997-09-25 Injection point without needle. Expired - Lifetime ES2277625T3 (en)
ES2277625T3 true ES2277625T3 (en) 2007-07-16
ES97943606T Expired - Lifetime ES2210582T3 (en) 1994-06-20 1997-09-25 Needleless injection device.
ES03005962T Expired - Lifetime ES2277625T3 (en) 1994-06-20 1997-09-25 Injection point without needle.
DE (4) DE69726603T2 (en)
EP3319682A4 (en) 2015-07-08 2019-05-01 Infusion Innovations, Inc. Valve assembly and methods of use