Medical syringe
33 claims: 6 independent, 27 dependent
- 1Szabadalmi igénypontok 1. Orvosi szelep, azzal jellemezve, hogy tartalmaz egy szelepházat, amely szelepház magában foglal egy belső üreget meghatározó falszerkezetet, van egy közelebbi és egy távolabbi vége, a közelebbi végén van egy olyan nyílás, amely elegendően nagy ahhoz, hogy tetszőleges orvosi szerelvénynek a kimenetéhez illeszthető legyen, amely orvosi szerelvényen folyadékot továbbítunk, tartalmaz továbbá egy szúróelemet, amelynek van egy csúcsa, és legalább egy, a csúcs közelében elhelyezett nyílása, továbbá egy olyan járata, amely lehetővé teszi, hogy a folyadék átáramoljon ezen a nyíláson, a szúróelem az üreg belsejébe van elhelyezve úgy, hogy a csúcsát magába foglalja az üreg, tartalmaz továbbá egy olyan tömítőelemet, amely összenyomott állapotba kerül akkor, ha az orvosi szerelvénynek a kimenetét a közelebbi végén lévő nyílásba helyezzük, és a tömítés visszatér dekompressziós állapotba, ha az orvosi szerelvénynek a kimenetét eltávolítjuk, a tömítésnek a dekompressziós állapotában van egy olyan tartománya, amely teljes egészében kitölti a szelepház közelebbi végénél lévő nyílással szomszédos üreget, és lényegében a szelep közelebbi végével egy szintbe helyezkedik el, míg a szúróelemben lévő nyílások fluid kommunikációs kapcsolatban vannak az orvosi szerelvénynek a kimenetével, amikor a tömítés összenyomott állapotban van.
- 2Az 1. igénypont szerinti orvosi szelep, azzal jellemezve, hogy a szelepnek a közelebbi vége - 44 lényegében síkra van kiképezve, és ez a sík felület az üreg közelebbi végével lényegében egy síkban helyezkedik el.
- 3Az 1. igénypont szerinti orvosi szelep, a jelleme zve, hogy a tömítésnek a közelebbi vége és ezen belül is a közelebbi végnek legalább egy része az üreg közelebbi végével egy szintben van elhelyezve.
- 4Az 1. igénypont szerinti orvosi szelep, jeli e m e z v e, hogy a szelep az orvosi szerelvény kimeneti végével összenyomhatóan van kiképezve, úgy, hogy eközben a közelebbi végen lévő nyílástól eltávolodik, és a tömítés a szelep test ürege felé nyomódik be.
- 5Az 1. igénypont szerinti orvosi szelep, azzal jellemezve, hogy a tömítés és a szelepház falszerkeziete között folyadékzáró tömítés van biztosítva, a tömítés összenyomott állapotába elmozdítva a szelepház falszerkezetén felfekszik és a tömítést az orvosi szerelvény kimenete kimozdítja az üreg irányába.
- 6Az 1. igénypont szerinti orvosi szelep, azzal jellemezve, hogy tartalmaz egy olyan tartószerkeze tet, amely a szúróelemhez van csatlakoztatva, és amely a belső üregnek a távolabbi végét szabaddá teszi, ez a tartószerkezet egy Luer-Lock típusú csatlakozó elem, amely lehetővé teszi, hogy a szelep eltávolíthatóan legyen csatlakoztatható a beteghez csatlakoztatható folyadék vonalba.
- 7Az 1. igénypont szerinti orvosi szelep, azzal jellemezve, hogy a szelep egy olyan szerkezetet tartalmaz, amely a szúróelemhez van csatlakoztatva, amely a szelep test belső üregének a távolabbi végét teszi szabaddá, ez a tartóelem egy olyan csatlakozó elemet tartalmaz, amely lehetővé teszi, hogy a szelep eltávolíthatóan legyen a folyadék tartályhoz csatlakoztatva.
- 8Az 1. igénypont szerinti orvosi szelep, azzal jellemezve, hogy a nyílás a szúrófej oldalában van a csúcs közelében kiképezve.
- 9Az 1. igénypont szerinti orvosi szelep, azzal jellemezve, hogy a tömítőelem anyaga 3 - 70 Shore keménységűre van megválasztva. kiképezve, amelyek egymás után elhelyezve egységes szerkezetet képeznek.
- 1012. A 11. igénypont szerinti orvosi szelep, azzal jellemezve, hogy az 0-gyűrűk növekvő átmérőjűre vannak kiképezve, és a legkisebb átmérőjű rész van az üreg közelebbi végének közelében elhelyezve.
- 1113. Az 1. igénypont szerinti orvosi szelep, azzal jellemezve, hogy az üreg egy sor sugárirányú bevágással van a belső falában ellátva, ezek a bevágások szomszédosak a tömítéssel, és kompresszió során a tömítőelem tágulását fogadják be.
- 1214. Az 1. igénypont szerinti orvosi szelep, azzal jellemezve, hogy a tömítésbe egy előre vágott hasíték van kiképezve, amely lehetővé teszi, hogy a szúrőelem csúcsa összenyomáskor könnyen hatoljon át a tömítésen.
- 1315. Az 1. igénypont szerinti orvosi szelep, azzal jellemezve, hogy a szelepház egy első záróelemmel van ellátva az üreg távolabbi végének a közelében, a szúróelem pedig egy második záróelemmel van ellátva, amely az első záróelemmel zárható kapcsolatot képez, a tömítés el van látva egy olyan peremmel, amely a tömítés hátsó végén túlnyúlik, és az első és a második záróelem között helyezkedik el úgy, hogy tömítő perem egy lényegében folyadékzáró tömítést képez akkor, és a közöttük lévő peremet összenyomják.
- 1416. A 15. igénypont szerinti orvosi szelep, azzal jellemezve, hogy a tömítés csonkakúp alakú szegmenssel is el van látva, amely az üregben helyezkedik el.
- 1517. Az 1. igénypont szerinti orvosi szelep, azzal jellemezve, hogy a tömítés egy sapka alakú peremmel van ellátva, amely a szelepház közelebbi végénél csatlakoztathatóan van elrendezve.
- 1618. Az 1. igénypont szerinti orvosi szelep, azzal jellemezve, hogy a tömítés légzsákokat tartalmaz, amelyek a tömítés mozgását könnyítik meg.
- 1719. Az 1. igénypont szerinti orvosi szelep, azzal jellemezve, hogy a szúróelem legalább egy olyan bordával van ellátva, amely lehetővé teszi, hogy a levegő a tö mítés és a szúróelem közötti hasítékba belépjen, ily módon megkönnyíti a tömítést, amikor az orvosi szerelvényt eltávolít• · juk.
- 1820. Az 1. igénypont szerinti orvosi szelep, azzal jellemezve, hogy a szelep úgy van kialakítva, hogy orvosi fecskendők, illetőleg IV rendszerekhez és vezetékekhez csatlakoztatható.
- 1921. Az 1. igénypont szerinti orvosi szelep, azzal jellemezve, hogy az üregnek a közelebbi vége ANSI szabvány szerint készült orvosi szerelvények végeihez szorosan illeszthetően van kialakítva.
- 2022. Az 1. igénypont szerinti orvosi szelep, azzal jellemezve, hogy a szúróelem legalább három nyílással van ellátva. szelepet, amellyel tartályhoz csatlakoztatható.
- 2125. A 24. igénypont szerinti orvosi szelep, azzal jellemezve, hogy az illesztő szelepnek van egy szúró eleme, amely a tartálynak a tömítését hasítja át akkor, amikor a szelepet a tartályhoz csatlakoztatjuk.
- 2226. A 24. igénypont szerinti orvosi szelep, azzal jellemezve, hogy az illesztő és csatlakozó szelepen sugárirányú hornyok vannak kiképezve, amelyek lehetővé teszik, hogy a tartályhoz illeszkedést követően a deformációja reverzibilis legyen. « * • ··· · · ·«· ···· · · ·· • · · · ··«···· ··
- 2327. Az 1. igénypont szerinti orvosi szelep, azzal jellemezve, hogy a szúróelem lényegében kúp alakúra van kiképezve, és a tömítésnek is egy lényegében kúp alakú ürege van, amely a szúróelem alakjához illeszkedik, és a szúróelem ebben az üregben van úgy elhelyezve, hogy a tömítés a szúróelem csúcsát is befedik.
- 2428. Orvosi szelep, azzal jellemezve, hogy tartalmaz egy szelepházat, amely tartalmaz egy belső üreget, amelynek egy közelebbi és egy távolabbi vége van, a közelebbi végén legalább egy akkor nyílás van, amely olyan orvosi szerelvények kimenetéhez illeszthető, amelyen keresztül folyadékot áramoltatunk, tartalmaz egy szúróelemet, amelynek csúcsa van, és a csúcs közelében legalább egy nyílás van kiképezve, és egy olyan járat van ezzel a nyílással kapcsolatban, amely lehetővé teszi, hogy a nyíláson a folyadék átáramoljon, tartalmaz továbbá egy rugalmas tömítő elemet, amely összenyomott állapotba kerül akkor, ha az orvosi szerelvénynek a kimenetét az üreg közelebbi végénél lévő nyíláshoz illesztjük, majd visszatér dekompresszált állapotba akkor, ha az orvosi szerelvény kimenetét eltávolítjuk, a tömítés közelebbi végénél legalább egy körgyűrű alakú tér van, amely dekompresszált állapotban lényegében folyadék záró tömítést valósít meg.
- 2529. Orvosi szelep, azzal jellemezve, hogy tartalmaz egy szelepházat, amelynek belső üreget képező falszerkezete van, az üregnek van egy közelebbi és egy távolabbi vége, a közelebbi végén egy legalább akkora nyílás van, amely folyadékot tartalmazó orvosi szerelvény kimenetének • · »· · · · · ·· befogadására van kiképezve, tartalmaz továbbá egy szúróelemet, amelynek csúcsa van, és a csúcsa közelében legalább egy nyílása van, tartalmaz továbbá egy tömítést, amely úgy van kiképezve, hogy összenyomott állapotba kerül akkor, amikor az orvosi szerelvény kimenete az üreg közelebbi részén lévő nyíláshoz illeszkedik, majd a tömítés visszatér dekompresszált állapotba, amikor az orvosi szerelvény kimenetét eltávolítjuk, maga a tömítés dekompresszált állapotában a szúróelem csúcsától adott távolságra helyezkedik el.
- 2630. Eljárás folyadék továbbítására valamilyen távoli folyadék forrás felől a beteg felé, a z zal jellee, hogy a) az orvosi szelepet a beteghez csatlakoztatjuk, az orvosi szelep tartalmaz egy szelepházat, amelynek olyan falszerkezete van, amely egy belső üreget vesz körül, és van egy közelebbi és egy távolabbi vége, a közelebbi végénél van egy olyan nyílás, amely elegendően nagy ahhoz, hogy a folyadékot továbbító elemnek a kimenetét befogadja, tartalmaz továbbá a szelep egy szúróelemet, amelynek csúcsa van, és a csúcsa közelében legalább egy nyílással van ellátva, és a nyíláshoz egy a folyadék áramlását ezen a nyíláson lehetővé tevő járat van csatlakoztatva, szúróelem az üreg belsejében úgy van elhelyezve, hogy a csúcsa az üregen belül helyezkedik el, tartalmaz továbbá a szelep egy tömítőelemet, amely összenyomott állapotba kerül, ha az 9 9» ···· «· . , » • · «· « • 9 · · · β • · · · · · ·· *· ·♦· ·«« ··” - 50 orvosi eszköznek a kimenetét az üregnek a közelebbi nyílásába helyezzük, és visszatér dekompressziós állapotba, ha az orvosi eszköz kimenetét eltávolítjuk, és a tömítésnek a dekompressziós állapotában van egy olyan tartománya amely az üregnek azt a részét, amely egy nyílással szomszédos, teljes egészében kitölti, ez a tömítés tartomány a nyílás közelében a falszerkezethez teljes egészében felfekszik, és összenyomott állapotban a tömítés az orvosi szerelvény kimenete által van betolva, és a nyílástól távolodóan elhelyezve az üregen, b) az orvosi szerelvény folyadékot továbbító kimenetét behelyezzük a nyílásba, eltoljuk az üreg irányába úgy, hogy a tömítést összenyomjuk, és az összenyomás mértéke olyan, hogy lehetővé teszi, hogy a szúróelemnek a csúcsa az orvosi eszköz kimenetéhez úgy csatlakozzon, hogy a folyadék a beteg felé tudjon áramolni.
- 2731. A 30. igénypont szerinti eljárás, azzal jellemezve, hogy a folyadékot úgy továbbítjuk a beteg felé, hogy a folyadékot olyan nyomás alá helyezzük, amikor az az orvosi eszközhöz csatlakozik, amely nyomás nagyobb, mint a betegben lévő folyadék nyomás, ily módon téve lehetővé azt, hogy a folyadék a beteg felé áramoljon.
- 2832. A 30. igénypont szerinti eljárás, azzal jellemezve, hogy a folyadék nyomása a betegben nagyobb, mint a folyadékot továbbító folyadék forrás nyomása, ily módon a folyadék a beteg felől tud áramolni,.
- 2933. A 30. igénypont szerinti eljárás, azzal jellemezve, hogy a szelep kétutas szelepként van kiképezve, és így a beteg felé vagy a beteg felőli folyadékáramot is - 51 lehetővé teszi.
- 3034. Eljárás folyadék továbbítására olyan tartályból, amelynek nyitott szája van, ez a nyitott kimenet egy fedéllel van ellátva, amely a nyitott részt tömíti, azzal jellemezve, hogy a) az orvosi szelepet a beteghez csatlakoztatjuk, az orvosi szelep tartalmaz egy szelepházat, amelynek olyan falszerkezete van, amely egy belső üreget vesz körül, és van egy közelebbi és egy távolabbi vége, a közelebbi végénél van egy olyan nyílás, amely elegendően nagy ahhoz, hogy a folyadékot továbbító elemnek a kimenetét befogadja, tartalmaz továbbá a szelep egy szúróelemet, amelynek csúcsa van, és a csúcsa közelében legalább egy nyílással van ellátva, és a nyíláshoz egy a folyadék áramlását ezen a nyíláson lehetővé tevő járat van csatlakoztatva, a szúróelem az üreg belsejében úgy van elhelyezve, hogy a csúcsa az üregen belül helyezkedik el, tartalmaz továbbá a szelep egy tömítést, amely összenyomott állapotba kerül, ha az orvosi eszköznek a kimenetét az üregnek a közelebbi nyílásába helyezzük, és visszatér dekompressziós állapotba, ha az orvosi eszköz kimenetét eltávolítjuk, és a tömítésnek a dekompressziós állapotában van egy olyan tartománya, amely az üregnek azt a részét, amely egy nyílással szomszédos, teljes egészében kitölti, ez a tömítés tartomány a nyílás közelében a falszerkezethez teljes egészében felfekszik, és összenyomott állapotban a tömítést az orvosi szerelvény kimenete tolja be, · ·· • · V · ·· • te te • ·« · ·« * · • · · · - 52 és a nyílástól távolodóan elhelyezve az üregen, b) az orvosi szerelvény folyadékot továbbító kimenetét behelyezzük a nyílásba, eltoljuk az üreg irányába úgy, hogy a tömítést összenyomjuk, és az összenyomás mértéke olyan, hogy lehetővé teszi, hogy a szúróelemnek a csúcsa az orvosi eszköz kimenetéhez úgy csatlakozzon, hogy a folyadék a beteg felé tudjon áramolni.
- 3135. A 34. igénypont szerinti eljárás, azzal jel1 eme z ve, hogy a folyadékáramot a tartályból a nyomás különbség által létrehozott járaton keresztül továbbítjuk.
- 3236. A 35. igénypont szerinti eljárás, azzal jellemezve, hogy a szelepet olyan illesztő elemmel látjuk el, amelyben sugárirányú rések vannak kiképezve, és ezek lehetővé teszik, hogy az illesztő elem elegendő módon reverzibilisen deformálódhasson, és így a tartályhoz szorosan illeszkedjen.
- 3337. Eljárás előre megadott mennyiségű folyadék továbbítására egy orvosi kezelőanyagot tartalmazó tartályból a beteg felé, azzal jellemezve, hogy a) a szelepet a beteghez csatlakoztatjuk, a szelep el van látva egy olyan nyílással, amely elegendően nagy ahhoz, hogy az orvosi szerkezetnek a folyadékot továbbító végéhez illeszkedjen, innen egy előre megadott mennyiségű folyadékot továbbítunk, a szelep maga tartalmaz egy szúróelemet, amelynek csúcsa van, a szúróelemben pedig nyílások vannak kiképezve, maga a szelep el van látva egy rugalmas tömitőelemmel, amely az orvosi szerkezetnek a kimenete által összenyomott állapotban mozgatható akkor, hogyha a kimenetet a szelephez illesztjük, a tö···· *· ··· • · ·· ·· 4 • ··· · ·«·· • · * · · · 4· ·· »· ··· ···· ·· mítés visszatérte kompresszált állapotba, ha a kimenetét eltávolítjuk, ekkor a szelep zár, az orvosi eszköz kimenete és a tömítés úgy van egymáshoz csatlakoztatva, hogy a szúróelemnek a csúcsa a tömítésen át halad, és mindez úgy valósul meg, hogy az orvosi eszköz kimenete és a tömítés között holt tér nem alakul ki, b) az orvosi eszköznek a kimenetét a szelepbe helyezzük, majd megnyomjuk az orvosi eszköz kimenetét, úgy, hogy ez a tömítést elegendő mértékben összenyomja, és lehetővé tegye, hogy a szúróelemnek a csúcsa a tömítést átszúrja, és az orvosi eszköz kimenetéhez illeszkedjen, és a tömítés és az orvosi elem kimenete lényegében holttér nélkül kapcsolódjon egymáshoz, c) a folyadékot a beteghez közvetlenül a szelepen keresztül továbbítjuk, úgy, hogy az előre megadott mennyiségű folyadék veszteség és holttér nélkül halad át a szelepen, d) az orvosi eszköz végét visszahúzzuk a szelepből, a tömítés visszatér dekompresszált állapotába, zárja a szelepet, és ebben a dekompresszált állapotban folyadék záró tömítést valósít meg nagy nyomások, és ismételt használat esetén is. A meghatalmazott:í'Vmh.' ,/í Q, \ i I l 4, g - c \ / O.. A. DANUBIA Szabadalmi és Védjegy Iroda Kft. ' i A V
Independent claims33
127 paragraphs, as filed
FIELD OF THE INVENTION The present invention relates to a medical valve which is designed as a closed system that is well-acceptable to patients and automatically sealed after administration of the drug, even if generally known and standard medical equipment is used which is directly connected to the system and without the need for intermediate needles, closures or fittings. The two-way valve of the present invention minimizes the dead zone that would otherwise occur and is provided with a seal that is compressed and pierced by medical equipment, which opens the valve and repeats and seals after decompression, even at high pressures, the liquid sealing seal is secured and can be maintained after repeated application.
The use of fluids for parenteral treatment in hospitals or medical institutions generally requires the use of various switching elements and adapters to facilitate fluid movement between two points. Most fluid couplings and adapters include needles that pierce the upper septum of a sterile tube or piercing the septum of a medicine container. Subsequently, the fluid flows from the reservoir or tube filled with the liquid into a syringe or into another tube system. These coupling and coupling elements generally contain a large number of mechanical or moving parts. Because the proper passage of fluids through these switches and adapters is often critical for the patient's survival, it is important that they function reliably and repeatedly and reusably. Adapters and switches that do not function properly during use often pose a life threat. The more mechanical or movable parts of such a coupling or coupling member, such as springs or diaphragms, the more likely it is that they will not function properly. Malfunctioning may also cause air bubbles to enter the patient's body. Thus, the fewer mechanical parts in such a system, the more reliable they are to operate and the more favorable they are to be accepted by the medical community.
Many coupling elements or valves are known, but generally contain various mechanical components and have a relatively large volume of liquid to carry. This so-called dead space within a given structure prevents a sufficiently accurate amount of fluid volume from being delivered to the patient, and there is a possibility that when it is disconnected from the structure it becomes contaminated. The switches and adapters that are thus employed often include valves to interrupt or enable fluid flow. Structures of this kind generally use metal tubes to pierce the sterile seal. The coupling and coupling elements thus formed are generally designed to allow the fluid to flow in only one direction. This means that connecting elements and pipes along the liquid flow line must also be installed that allow reverse flow. However, such couplings are difficult to handle and, for example, if the valve is carelessly assembled in one direction, the fluid will not flow properly. These various steps make the device more difficult to handle, increase the potential for contamination, and, in addition, require a relatively long time to establish the correct fluid connection.
The metal needles that are part of the coupling members increase the risk of stabbing or wounding the patient. The needles used in these devices are generally provided with a through hole formed at the needle tip. To connect the valve to such a flow of fluid, it is necessary to insert a needle through the sealed bulkhead. However, through holes near the tip of the needle may optionally drill through the septum and release free particles into the fluid stream. This may be fatal for the patient. In addition, the through holes formed at the top of the needle can be easily contaminated with particles from the bulkhead material.
Reusable connector and switching elements are advantageous for medical purposes, as it is often necessary to add various components or remove one component from the patient's fluid stream. However, the difficulty of using reusable switches is that they are difficult to keep sterile. Often, various lids or caps are used to cover the attachments to keep them sterile. However, it is not infrequent that these protective caps are lost or simply not used because they are not at hand when needed.
Therefore, there would be a need for a closed system with a patient-friendly, easy-to-use valve that does not require a separate cap or requires a needle or adapter to be connected to the system, to be properly cleaned, to maintain its function after various treatment processes, and, even at high pressures, be fitted with a suitable fluid-tight seal. Such a system would certainly be well received by the medical community.
The valve of the present invention has many novel features, but not all are described in detail herein. Without limiting the scope of the invention, the spirit of the invention is described in the claims.
Reading the description of the invention, it will be appreciated that the invention has many advantages, such as being safe, reliable, simple and reproducible, minimizing dead space, easy to use, and using a valve that can be cleaned after use, sterile and good liquid has sealing parameters even at high pressures.
SUMMARY OF THE INVENTION The present invention is a closed system, readily accessible to patients, which, after treatment with any drug, automatically re-seals and connects directly to the patient-attached system without the need for a needle or other cap or adapter.
The two-way valve of the present invention is provided with a re-usable seal that can be repeatedly pierced by a protected non-metallic piercing member provided with the system, thus eliminating the need for an external metal needle. The use of the valve facilitates the flow of the liquid medium, especially the liquid, while maintaining the sterility of the liquid. The valve itself is easy to use and locks and locks. After use, the valve may be cleaned in a manner known per se using known means to maintain sterility. The valve is designed to prevent accidental needle sticking.
As described in more detail below, the valve can be used as a medical connector and adapter to allow fluid to flow from a properly sealed container.
An essential feature of the invention is that the valve is provided with a valve body having a wall structure which forms an inner cavity having a proximal and a distal end. The cavity has an open space portion into which a suitable seal can be pushed in, and further, adjacent radial recesses are formed in the wall structure which face the seal and allow the seal to expand under pressure. There is an opening at the proximal end of the cavity that is large enough to allow the drug or
- Receives the outlet of 7 medical supplies, from which medical supplies then flow into the cavity. In most applications, the aperture end of the medical device is generally tapered, and the wall structure attached to this end of the device containing the pharmaceutical composition is also inwardly tapered, so that the end of the device containing the fluid can fit snugly, created. The proximal end of the cavity is preferably configured to fit the end of a device containing medical agents as required by ANSI (American National Standard Institute, Washington, DC). Typically, such a medical device may be the inlet or outlet of a syringe, or a set of inlet and outlet connectors, or any wire used in medical medicine.
A further feature of the present invention is that the piercing and splitting element has a tip having at least one hole disposed near the tip and the hole at the tip being configured to flow through this fluid. At its piercing edges, it is positioned inside the cavity so that the apex is located at the proximal end of the cavity. It is preferred that the hole or cavity located near the apex is elongated and has a size of 18 gauge or larger. The tip of the puncture member may be sharp or slightly rounded. In many cases, it is preferable to have a design having more than one hole near the apex, and preferably having three symmetrically arranged holes at the proximal end.
The puncture member itself is provided with at least one rib that allows air to enter the space between the seal and the puncture member, thereby facilitating sealing of the opening when a suitable medical device, such as a syringe, has been removed. The puncture member itself is substantially conical, and the seal is also conically formed on its matching shape, i.e., it conforms to the shape of the apex. The puncture member is located in the conical cavity and has a suitable seal covering its top. This cover covers the tip of the puncture member and the tip itself is embedded in the proximal end of the seal or retracted into the conical cavity. Advantageously, a plurality of ribs are formed at the apex of the puncture member, which are each in a recess. It can be beneficial as an example! Another embodiment wherein the puncture member can pierce the seal without breaking the seal. In the case of injection molding of a plastic piercing tool, which may be an exemplary embodiment, the ribs at the apex fit along a delimiting line and may form a rough flange that may break the seal. This problem can be solved by separating the separation line in the recesses. Thus, the coarse flanges at the separation line are located in these recesses and the sealant passes over the recesses and thus does not come into contact with the rough edges and flanges.
A further feature of the present invention is that the resilient sealant is formed such that when a particular medical device, such as a syringe, is inserted into the opening,
- It gets into 9 compressed states and returns to the depressed state when the tip is moved. When the seal is uncompressed, it has a region that substantially fills a portion of the cavity adjacent to an opening. The seal itself lies on the wall structure and wall design near the opening and seals the opening completely. When compressed, this seal is shifted from the opening towards the cavity by a medical device, such as a syringe. The fluid-tight seal is secured between the sealing region and the wall structure even when the seal is in a compressed state. Most importantly, the outlet of a medical device, such as a syringe, and the gasket are interconnected such that when the tip of the puncture member pierces the gasket, there is essentially no dead space between the gasket and the fluid delivery end. In this way, it is ensured that a precisely predetermined dose can be delivered from the particular medicine to the patient and that no dead space or dead space will occur within the valve itself. Because in many cases the delivery of drugs or the amount delivered can be critical, such as chemotherapy treatment, which in many cases is used to treat young children, it is very significant that the present invention can deliver an accurate amount of medicine.
The liquid-sealed state itself and the seal are secured even if the valve is opened or closed several times, and there is a small notch on the outer surface of the seal, which forms an air bag that moves the seal • · · ♦
- 10 lighten. Preferably, the seal itself forms a surface which is flush with the proximal end of the cavity. As an example! In the embodiment, the proximal end of the seal is substantially flat and is preferably made of a material having a hardness of 30 to 70 Shore units, such as a silicone polymer. The gasket may also be provided with a cap-like rim attached to the valve housing at the proximal end of the cavity. The seal itself may be a member of a series of O-rings which are joined together to form a unitary structure. The 0-rings may also be formed by being joined to one another with increasing diameter, and the 0-ring having the smallest diameter being located at the proximal end of the cavity. The proximal end of the cavity may be provided with a notch that forms a thin opening and allows the tip of the puncture member to easily pass through, thereby easily compressing the seal. The proximal end of the seal may also be formed as a truncated cone segment which is then located in the cavity. The seal may also be provided with a centrally located anti-vacuum saucer-like depression element that does not interfere with the proximal end of the seal being cleaned if necessary.
A further feature of the invention is that the valve body and the piercing member are two separate components of the valve and are securely secured to one another by means of a suitable locking arrangement. The valve body itself is provided with a first closing or locking member disposed near the distal end of the cavity and a
<img file="HUT67968A_D0001.tif" />
- a second locking-locking member 11 which engages the first locking member during assembly. The seal itself is provided with a flange that extends at its distal end and is disposed between the first and second locking members so that the assembly itself, when assembled, holds the flange between the locking members and this ensures a fluid-tight arrangement even during installation.
A further fifth feature of the medical valve of the present invention is that it comprises a device attached to the piercing member which ultimately opens the distal end of the cavity. Such a device may be, for example, a Luer-Lock type connector, which allows the valve itself to be removably fitted, for example, to a fluid conduit, which may be connected to the patient. This support may also be an adapter that allows the valve to be removably attached to the fluid dispenser or fluid container. When the fluid is conveyed from the fluid dispenser or fluid reservoir, the puncture member has a pair of opposed ends, preferably at the distal and proximal ends of the puncture member. The tips at the distal end of the puncture member pierces the lid element which seals the container or container. The radial slits of the adapter allow the seal to be reversibly deformed and fit snugly into the container.
Another sixth feature of the present invention is that the seal comprises a pressure sensing element at its proximal end, which is the seal. placed on its inner surface near the opening. This pressure-sensitive member closes all openings in the gasket at the proximal end of the gasket in a decompression state, thereby achieving a substantially complete fluid-tight state in the decompression state. The pressure-sensitive element allows the valve to remain in a sealed state even at high pressures, which are sometimes required in medical medicine, especially when the valve is connected to a patient's artery. The valve of the present invention remains closed even when the pressure inside the valve is above 6 psi and can withstand up to 30 psi. However, it is typical that the pressure sensitive element placed on the valve is also provided with an inlet portion which is connected to a pre-formed opening. This region of the valve is essentially a cylindrical arrangement surrounded by an annular gap filled with fluid under pressure. The central portion of this element and the annular slot are coaxial with each other and coaxial with the inlet. The pressurized fluid fills the annular gap, exerting pressure by compressing the cylindrical region, thereby sealing the orifice. This pressure-sensitive member is preferably formed of a non-rupture member.
In accordance with the present invention, a predetermined amount of the drug or medical excipient can be delivered directly to the patient, which can be achieved by:
- Of the 13 preset amounts of medicine, nothing remains in the dead space of the valve. In other words, virtually every predetermined dose is given to the patient, so there is no loss from the valve. The method and arrangement of the present invention allows the transfer of fluid from any remote source of fluid to the patient. However, the present invention also provides the ability to transfer fluid from a patient to a remote source of fluid. This is made possible by the fact that the valve according to the invention provides a two-way fluid transfer, thus acting as a two-way valve. The fluid that is transferred to the patient by passing the fluid under suitable pressure passes through a medical device, such as a syringe, and the pressure exerted on the fluid is greater than the pressure on the fluid in the patient, thus thus ensuring that fluid is delivered to the patient. However, when removing or transferring fluid from a patient to an external source, the pressure of the fluid in the patient should be greater than that of the external source of fluid, allowing the fluid to flow from the patient to the external source. to a liquid source
Thus, one of the methods of the present invention is to transfer the liquid to a liquid collection vessel having an open mouth portion covered by a lid that seals it properly. The fluid that continues to flow from the reservoir through the fluid stream creates a differential pressure. For the purpose of the present invention, the valve itself is provided with an adapter having radial grooves which allow the adapter to deform sufficiently reversibly to provide a tight closure of the container after use.
The invention will now be described in more detail by way of exemplary embodiments, in the accompanying drawings. The description and drawings illustrate parts of the invention which support the novelty rather than the obvious nature of the invention.
Figure 1 is a perspective view of a first embodiment of a valve according to the invention, a
Second Figure 1 is an exploded view of the embodiment shown in Figure 1, showing the puncture member, the seal, and the valve body in a three-dimensional drawing;
Third Fig. 1 is a longitudinal sectional view of the valve of Fig. 1;
4th Figure 1A is a longitudinal sectional view of the valve of Figure 1, when the valve is already assembled, the medical assembly is connected and the gasket is not yet compressed;
5th Figure 4 is a longitudinal sectional view of the embodiment shown in Figure 4 with the seal in the valve in the compressed state;
6th FIG. 3 is a perspective view of a second exemplary embodiment of the present invention;
7th Figure 6 is a longitudinal sectional view of Figure 6;
8th Figure 2 shows the embodiment where it can be observed that:
- how to compress a seal in a valve according to the invention to an ANSI standard outlet connected to a medical device such as a syringe,
9th Fig. 2A is a side elevational and partially sectional view of a third embodiment of the valve of the present invention;
10th Figure 1 is a longitudinal sectional view of the valve shown in Figure 1 with the seal shown in Figure 9;
11th Figure 1A is a longitudinal sectional view of the valve assembly of Figure 1 with a seal formed in accordance with a fourth embodiment of the present invention;
12th Fig. 2A also shows the valve assembled according to Fig. 1, but with a fifth kind of seal according to the invention, also in longitudinal section,
13th Figure 6A is a longitudinal sectional view of a valve according to the invention with a seal formed in a sixth embodiment;
<td> 14.</td><td>Figure a</td><td> 13.</td><td>Figure</td><td>shown seal</td><td>longitudinal section</td>
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is a longitudinal section of its shape,
16th Figure 15 is a longitudinal sectional view of the arrangement using the valve of Figure 15;
17th Fig. 4A is a longitudinal sectional view of a valve arrangement according to an eighth embodiment of the present invention;
18th Figure 9 is a longitudinal sectional view of a ninth embodiment of the valve of the present invention; »·« «··· ··
19th Figure 14 is a side view, after assembly, of the seal and piercing member of Figure 14 connected to the valve housing of Figure 20 and Figure 21;
20th Figure 29 is a sectional view taken along line 20-20 of Figure 29;
21st Figure 3A shows a partially broken spatial drawing
13th and the seal shown in Figure 14 and the associated cavity, a
22nd Figure 14 is a sectional view taken along line 22-22 of Figure 14.
It should be noted at the outset that when referring to the proximal end of the valve or the elements designated by the proximal end of the description and the drawings, reference is always made to the parts nearer to the tip 32. This is illustrated in greater detail in Figures 25, 10-12, 14 and 16, and Fig. 6, when talking about the prong 60. Similarly, Figures 8, 9 and 13-19. Referring to FIGS. 1 to 4, cap 92 is also referred to as a cap at the proximal end. The term "distal end" means the opposite end of the valve or piercing member. The term "medical equipment" refers to essentially any medical tool or device which is obvious to one of ordinary skill in the art to be able to attach it to the valve of the present invention and to facilitate the flow of liquid or liquid * · 44 «ι · 4 4 · 44 ·
- 17 fluid currents. Such medical fittings may be, for example, any tube, tubing, syringe, IV set, both peripheral and central lines, interconnecting plugs, or other arrangements and elements related to medical valves. These medical devices are usually of standard size. Each end of the valve of the present invention may be provided with suitable coupling and fastening elements and thus be used with standard medical formulations and devices.
As a first example of the invention! 1 and 2, where Fig. 1 is a perspective view of a valve 10, and Fig. 2 shows the same valve 10 when disassembled, showing a valve body 12, a puncture member 24, and a seal 3 6. The seal 3 6 is preferably made of a resilient material which is sufficiently inert and impermeable to liquid, moreover capable of being slit by means of a puncture head 26. Later, Article 13. Fig. 6a shows a more detailed seal 36d, wherein the seal 36d is provided with a slit 11 at the proximal end thereof. This pre-slit 11 essentially forms a small opening which allows the tip 32 of the puncture member 24 to easily penetrate the seal 36, while still providing a suitable fluid sealing seal when the puncture member is punctured. These three components are shown in Figure 3. FIG. 4A, where it is observed that the puncture member 24 is positioned such that it cannot cause a random puncture to external persons. Figure 2 illustrates how the valve body 12, the seal 36 and the piercing member 24 can be joined together without the need for any adhesive or binder. The mechanical connection, which ultimately provides the proper fluid seal and proper seal, will be described in detail below. Articles 4 and 5. In the embodiment shown in FIG. 6B, the seal 36 moves in the valve housing 12, piercing the piercing member 24 so that the tip 32 of the piercing member 24 allows fluid to flow through the valve 10.
Referring now to Figure 1, which is an exemplary embodiment of the invention, the valve body 12 is provided with a bell-shaped collar 16, and its upper portion, to which the bell-shaped collar 12 is also connected, is a substantially cylindrical conduit 20. The bell-shaped collar 216 forms a unit with an annular member 14 connected thereto and also connected to the conduit 20. The collar 16 is essentially a shield for the inner conductor 18 of the puncture member 24. This inner conductor 18 is also preferably cylindrical in shape and is slightly tapered. The inner conductor 18 and the upper conductor 20 are arranged in series and form substantially hollow tubes such that the inner conductor 18 and the upper conductor 20 are in fluid communication with each other when the piercing member 24 pierces the seal 36. The system further comprises an annular flange 25 at the upper end of the conductor 20 which is shown in FIG. FIG.
In a first embodiment of the present invention, the upper conduit 20 is configured to engage a neck 48 of a syringe conforming to the SANSI standard as shown in Figures 4 and 5. Of course, the outer diameter of the upper conductor 20 may be arbitrarily configured to be coupled to other connecting devices or interface devices. Preferably, the proximal end of the upper conduit 20 is provided with a suitable locking mechanism and a locking mechanism which allows the valve 10 to be connected to various switching devices and structures. 1. 3A. In this embodiment, this structure is provided, for example, by the locking tabs 22 formed on the proximal end of the annular rim 25 which forms part of the valve body 12 and these locking tabs 22 are compatible with what is known in the art as Luer-Lock. and they can be connected to it. The 19th. Fig. 4a will show a known Luer-Lock closure which is a threaded portion 180, which may be formed, for example, along the outer diameter of the upper conduit 20.
Returning to the
Second 1 to 4, the inner conductor 18 is disposed at the distal end of the puncturing element 24, while the proximal end has a hollow puncture head 26 which forms a unit with the inner conductor.
The inner conductor 18 and the nozzle 26 allow continuous fluid flow during use.
Also shown is an annular sleeve flange 28 disposed about the center of the puncture member, forming an integral part thereof, for connecting the inner conductor 18 to the puncture head 26. THE 3. It is shown that there is also a perimeter 28a which is part of the collar flange 28 and which seals the inner part of the annular member 14 properly, but also has a hinge pin 28b provided on the lower portion of the annular member 14b. connected to a groove. The 28 sleeves perform two functions. First, it ensures that the ring member 14 is capable of engaging the structure and, on the other hand, forms a support and engagement member for the seal 36.
The hollow piercing head 26 is formed as a cone and terminates in a sharp piercing tip 32. A preferred embodiment is that ribs 30 protruding along the piercing head 26 are provided. These protruding ribs 30 preferably protrude from the surface of the mandrel 26 at a height of 0.2 to 2 mm. Preferably, the ribs 30 extend in the longitudinal direction of the piercing head 26, as can be seen in FIG. These ribs 30 serve the purpose of interrupting the vacuum generated when the prong 26 is sealed. Of course, the ribs 30 may be formed in other ways, moreover, they may have a different direction, and these will be discussed later. The tip 32 is configured to have at least one longitudinal through hole 34 at its end which allows fluid flow and communication between the inner conduit 18 and the upper conduit 20. However, it is preferred to have three such through holes 34 located about 0.2 inches from apex 32. These through holes 34 can also be of any size, usually of a convenient size, the larger these 34 are.
<img file="HUT67968A_D0002.tif" />
the size of the orifices, the greater the fluid flow rate through the valve 10. As an example! In the embodiment, the size of the through holes 34 is selected to be 18 gauge, and thus allow for a 18 gauge needle that can achieve a triple flow rate of standard size.
The seal 3 6, as shown in Figure 2, is provided with a sealing cap 40 having a preferably flat surface 40b, the rest having a slightly outwardly tapered side wall 38, and a lower sealing member 42 having a sealing flange 42. . The inside is hollow and includes a conical cavity 37 as seen in Figure 3. The seal 36 slides easily along the puncture member 24 and fits snugly into the cavity 37. The sealing flange 42 shown in the figure lies in the flange 28 and engages between the collar 28 and the annular member 14. Figure 2 clearly shows that longitudinal grooves 43 are formed along the seal 36, which form air bags, which facilitate the compression of the seal 36 in use. The grooves 43 may be of any shape and size, preferably by compression. THE 2. In the exemplary embodiment of FIG. 4A, there is a single groove 43 which completely surrounds seal 36 between seal 40 and seal 42.
At the base of the seal 36, the width of the seal 36 is formed such that the sealing flange 42 formed here fits exactly into the collar 28. The hollow inner part, such as the cavity 37 shown in FIG.
22 is also preferably conical in shape, or at least conforming to the inner shape of the puncture member 24, and the wall portion 44 is in contact with a sealing cap 40, as can be clearly seen in FIG. The size and shape of the outer side of the gasket 36 are selected to fit inside the upper conductor 20 of the valve body 12. The sealing cap 40 itself seals the valve 10 when its upper surface 40b is located above the through hole 34. Preferably, the sealing cap 40 fills the entire opening 25a in the upper portion of the conduit 20. Thus, once assembled, the upper surface 40b of the sealing cap 40 is substantially filled with the flange 25 and can be cleaned with alcohol or other disinfectant so that the disinfectant cannot enter the valve.
it is extremely important to ensure that the surface is thoroughly cleaned.
Returning to Fig. 3, adjacent inner conductor 44 is joined 12 to provide an annular member and annular member 14 to an inner puncture valve body flange 28,
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it is absolutely necessary that the two elements be secured to one another, but may be secured to each other in various ways, for example by heat sealing, gluing, pressure or other internal annular edges 27 held in place by the inner side of the annular member of the valve housing 12. The length of the piercing member 24 is selected such that, after assembly, the tip 32 of the piercing member 24 is located below a plane defined by the flange 25 of the valve body. Preferably, the tip 32 is 0.525 to 1 inch below the rim 25 of the valve body 12. The seal 36 itself fits exactly into the puncture member 24 and is substantially flush with the flange 15 of the valve body 12. The tip 32 is embedded in the sealing cap 40 prior to use and is preferably 0.025 inches from the sealing cap 40 when the valve 10 is closed. The inner conductor 18 is partially shielded by a bell-shaped collar 16, which is shown in FIGS. 6A and 8A, which is part of the valve housing 12. On the inside surface of the bell-shaped collar 16, a threaded wall portion 44 is provided, which is a convenient locking mechanism for fitting any medical device.
Optionally, other medical devices, such as pressure, may be fitted to the outer portion of the inner conductor 18 without the need for a threaded wall portion 44.
In use, the valve 10 of the present invention functions as a two-way valve. The orientation of the valve 10 is independent of the fluid flow, but only depends on the direction of the existing connection. Thus, the valve of the present invention can be used for intravenous central or peripheral plug connectors so that flow in both directions is possible. The parenteral fluid may be transported to the conduit 20 via the conduit such that the fluid flows from the reservoir containing the drug or other additives through the needle to the patient. Tanks need to be changed frequently or other different fluids from different tanks must be connected. The present invention allows various medical devices to be interconnected and transmitted to a patient. However, the present invention can be used in any environment where a resealable liquid valve is required. During use, the appropriate size connector fits into the inner conductor 18. Locking can be accomplished by a Luer-Lock mechanism, pressure locking, or other attachment and locking mechanisms known per se, as already mentioned. In one example, the fluid is conveyed from the inner conduit 18 to the puncture member. The liquid flow is sealed by sealing.
4 and 5.
The operation of the valve is illustrated in more detail in FIGS. THE
4th The medical device to be used is a syringe 46 that will engage the proximal end of the valve. Of course, any other medical equipment can be connected. As shown in Figure 4, the syringe 46 is connected to the sealing cap 40 at the annular rim 25 of the valve body 12 by a neck portion 48. When pressure is applied to the syringe 46 in the direction of the arrow shown, this pressure is applied to the sealing cap 40. The resulting pressure compresses the seal 36 as shown in FIG. As a result of pressure, the tip 32 of the nozzle 26 passes through the sealing cap 40 and exposes the through holes 34. Compression is facilitated by the grooves 43 as previously indicated. In this state, the fluid is able to flow to or from the syringe 46, depending on whether the fluid is to be delivered to the patient or the fluid is to be withdrawn from the patient.
Figure 5 shows that valve 10 opens when neck 48 of syringe 46 passes through orifice 25a. By pulling back the plunger 49 in the syringe 46, a vacuum is created which forces the fluid to flow into the syringe 46. For intravenous use, valve 10 may be positioned as shown in Figures 4 and 5, or may be rotated 180 ° so that fluid will flow in the opposite direction.
When the syringe 46 is removed from the nozzle head 26, the seal 36 returns to its original state and completely covers the through holes 34. The ability of the seal 36 to return to its original state is accomplished by selecting its material. In addition, the return of the seal 36 to its original state can be facilitated by forming the ribs 30 mentioned above on the top of the nozzle 26. During compression, a vacuum is formed between the nozzle head 26 and the seal 36, which prevents the seal 36 from returning to its original position. The ribs 30 allow air to flow between the nozzle 26 and the seal 30, thereby preventing the formation of a vacuum, and allow the seal 36 to return to its original state and position more easily. The deformation ability of the seal 36 should be reversible, i.e. it should be able to fully return to its original shape.
<img file="HUT67968A_D0003.tif" />
and thus
First immediately prevents fluid flow through valve 10,
Second completely covers the 26 nozzles so that sterility is maintained,
Third reduces the risk that the tip 32 of the puncture member 24 could injure or stab anyone. In addition, the valve 10 has no moving elements except the seal 36, so that the valve 10 has practically nothing to break or render inoperative.
The through holes 34 should preferably be positioned low in the puncture head 26. In this way, the through openings 34 are sealed relatively quickly when the seal 36 returns to its original position after the valve 10 is closed. In the exemplary embodiment, the through holes 34 are positioned below the tip 32 to 0.075. This embodiment is illustrated in Figure 2. In addition, the through holes 34 are sealed when the seal 36 does not completely return to its original state, as shown in FIG. The ability of the seal 36 to return to its original state allows the valve 10 of the present invention to be reused several times. After use and disconnection, before use, it is desirable that the sealing cap 40 is flush with the top of the valve housing 12. This surface can be easily wiped off with alcohol or other disinfectant. The annular collar 16 in the conduit 20 is preferably suitable
<img file="HUT67968A_D0004.tif" />
provides protection for the interconnected parts, thus providing additional security in that the interconnected parts remain sterile. The annular collar 16 and the conduit 20 form a collection container that prevents the fluid from dripping from the valve 10 during some form of connection.
A cap (not shown) can also be applied over the conductor 20 as an additional protection for the sealing surface during use. Such a cap may not be necessary, but is capable of providing adequate sterility for the seal 36 and may be washed with disinfectant after use. The reversible operation of the seal 36 allows the valve 10 to preferably be used as a switching valve, for example, and to provide a fluid flow between two fluid lines. The present invention allows a first fluid stream to be coupled to a second fluid stream, as will be discussed in more detail below. The reversibility of valve 10 also allows multiple fluid lines or fluid lines to be connected in sequence. For example, an additional stream of fluid may be added to a fluid stream that is directly connected to a patient's vein. Because valve 10 is easy to sterilize and seal, various fluid conduits can be connected and disconnected so that the connection to the vein is not interrupted.
The valve 10 itself is preferably made of hard plastic.
However, the valve may be made of other medically inert materials which are also known per se, so that these are not described in detail. The puncture member 24 is preferably made of the same material as the valve body 12. Another advantage of the present invention is that it does not require the use of metal needles. This greatly reduces the risk of piercing the skin during treatment and use. It is also advantageous that the upper conductor 20 essentially constitutes a shielding and protective element for the puncture head 26, which further reduces the possibility of skin pricking. The piercing head 26 must be strong enough to penetrate the sealing cap 40 or optionally to rupture the partition which connects the two systems.
2-4. In the exemplary embodiment shown in Figures 1 to 4, the through holes 34 are located at the proximal apex 32. This arrangement has two important benefits. First, the location of the through holes 34 makes it easier to release or shut off valve 10 after use. Secondly, if the through holes 34 are arranged at the tip 32, they can drill through the sealing cap 40, thereby forming a seal into the fluid medium stream and optionally plugging the through holes 34. The longitudinal design of the through holes 34 at the tip 32 prevents particles from entering the fluid stream and / or obstructing the through holes 34. The number of through holes 34, which are also internal holes, are different in number and diameter
<img file="HUT67968A_D0005.tif" />
<img file="HUT67968A_D0006.tif" />
can be selected according to fluid flow rates. In the exemplary embodiment, the flow rate of the fluid medium through the orifice 34 is equal to or greater than the flow rate of the gauge needle 14. The through openings 34 thus obstruct the flow of liquid or allow a flow rate greater than 18 gauge to be achieved.
Another important feature of the valve 10 of the present invention is that the dead space is very small, i.e., the liquid entering the valve 10 is substantially the same as leaving the valve 10. Because the total fluid volume of the valve 10 is very small, it is suitable to be placed in a fluid flow line that includes, for example, a syringe 46, since the dead space is substantially 0.
Figures 6 and 7 show a further exemplary embodiment of the invention, illustrating an adapter valve 50 which serves to form a resealable lid for a liquid container (not shown). Thus, a fluid can be removed from the container or it can be ensured that the fluid flows from the container to a medical device so that it is sterile attached to the valve housing. It is common practice for a container to have a mouthpiece sealed with a lid (not shown).
Figure 6 shows an adapter valve 50 having a bell-shaped collar 52 in its valve body. This collar 52 fits into the opening of the container. The collar 52 is designed to fit standard size medical equipment, but can be customized to fit any size. The collar 52 is provided with a longitudinal slot 54, in the exemplary embodiment a slot 54 is used, however, multiple slots 54 may be provided. Its role is to ensure a good fit between the collar 52 and the container. Figure 6 also shows a chamber 56 which is preferably cylindrical and extends upwardly from the collar 52, having a configuration similar to that of the conduit 20 shown in Figures 1 and 2. Similar to Figure 1. In the exemplary embodiment, the proximal end of the valve 50 is provided with a locking mechanism 59 and a locking mechanism, preferably comprising a Luer-Lock device or other locking member known to those skilled in the art, and will not be described in detail.
Figure 7 shows that a puncture member 58 is disposed within the chamber 56. Preferably, the tip 60 of the piercing member 58 is covered by the proximal lid 62 of the chamber 56. When closed, the tip 60 is completely covered by a seal 64, which is substantially the same as the seal 36 shown in the previous embodiment. The figure further shows ribs 66, which are also provided on seal 64, and grooves 68, which facilitate conversion in the open position and facilitate closure after use. Thus, in the closed position shown in Figure 7, the seal 64 covers the through openings 70 and thus prevents fluid from escaping from the container. The adapter 50 valves include a second 72 puncture elements arranged in opposite directions. like the puncture element 58. The pins 52 and 72 are in fluid communication with one another. The piercing member 72 extends downwardly in the collar portion 52. The two puncture elements 52 and 72 form one component of the fitting valve 50, while the collar 52 and chamber 56 are the other component. These two components can be fitted to each other in the same way as for valve 10. The puncture element 72 and the like puncture element 58 are provided with longitudinal through holes 74 and apex 76. The through holes 74 are located downward from the tip 76. The fitting valve 50 may be used for containers containing sterile drug and a lid or seal is provided at the open mouth of the container. Such containers are provided with such a seal and for which the valve of the present invention may be used, for example, antibiotic containers for intramuscular administration or the like. The adapter has 50 valves with its own insulation and closes mechanism, allows the valve to be used in different containers or in containers containing a variety of drugs or liquids. Containers for these types of drugs are generally kept in sterile conditions and the nature and volume of the drug requires that it be administered at intervals. When the medication is to be dispensed, the lid must be removed to open the medication. The insertion valve 50 of the present invention can be used so that it can be positioned at the lid of the drug reservoir and passes directly through its piercing members 72 into the reservoir. The syringe 46 shown in FIG. 4 can then be used for such purposes, which can then draw liquid from the container. The pressure at neck 48 over puncture member 58 extends tip 60 through seal 64. However, the gasket 64 will be pushed back and compressed. Compression is provided by the sealing grooves 68. The liquid is withdrawn from the reservoir and the syringe is then removed from the puncture member 58. The release of pressure allows the seal 64 to return to its original position and seal the container again. The ribs 66 facilitate the reversibility of the seal.
Frequently used drugs in a container that are lyophilized. Lyophilized components must first be handled properly before use. If the medicament is to be properly mixed before use, this usually means that sterile water, saline or other liquid must be added to the lyophilized additive before the liquid is withdrawn from the container. The two-way nature of the valve allows this to be accomplished without any special component or operation. The syringe has been removed and the adapter 50 seals automatically. The other connections can then be removed from the tank. Once the connectors have been removed, the tip 60 and the prong 58 can be wiped off with alcohol or other surface sterilizing agent before use. Similar to the first example! In this embodiment, a protective cap may be used which may be positioned above the chamber 62 for a period of time between two uses.
·*· · ·♦ ·· • · ·» * · « ·*♦· ♦ · ♦«· ·· ·· ··· · « « « ««
The interface valve 50 may also be used as a medical distribution and interface unit for an intravenous container. In this case, the adapter valve 50 is connected to a reservoir containing the intravenous fluid and, in addition, to the intravenous feed tube. The adapter valve 50 is thus located in the flow of fluid through which the intravenous fluid is delivered, thereby facilitating the flow of the drug from the container containing the intravenous fluid.
An embodiment 36a of the seal 36a is shown in Figure 9. The seal 36 includes a sealing cap 92 at the proximal end and a sealing flange 96 at the distal end. The cap-shaped annular rim 95 is disposed at the sealing face 92 of the seal 36a. The sealing cap 92 and the sealing flange 96 are connected to one another by a wall-shaped portion consisting of a plurality of annular wall elements 94 which are capable of expanding and contracting. When the seal 36a is compressed, the diameter of the annular wall members 94 expands radially outward. In this embodiment, airbags 13a of FIG. 1 are shown in more detail in FIG. 10 between FIG. 1 and seal 36a. FIG. Gasket 36a also comprises a cavity 98, further comprising a gasket cap 96 and annular wall members 94. The seal 36a is actuated by the piercing head 26 shown in FIG. Thus, seal 36a of FIG. 2A can be used in combination with all other elements of the embodiment of FIG. 2.
Figure 10 shows that the sealing cap 95 forms an annular rim ··· »* · Λ« 4 • · · ··· «<« that can be pulled onto the upper conductor 20 and held in place by a sealing ring 97. This design allows the seal 36a to readily return to its decompression state when the syringe is withdrawn. This embodiment has two advantages. One is that the proximal end of the valve 10 can be washed with alcohol or other disinfectant so that nothing of the disinfectant can infiltrate the valve 10. Another advantage is that the cap-like fastening of the sealing cap 95 to the conduit 20 at its proximal end with the sealing ring 97 shown in the figure allows the seal 36a to be deformed again or re-formed.
Figure 11 shows a further embodiment of the sealing member 36b of the present invention, which is incorporated into the valve 10. The seal 36b is similar to the seal 36, has a sealing cap 92, and the sidewall is also made of annular wall elements 94, and a sealing flange 96 is formed at the other end. There is also an outwardly extending seal ring 99 at seal 36b which is perpendicular to the longitudinal axis of valve 10. The role of the sealing ring 99 is to fit the seal 36b to the upper conductor 20. It is advantageous if the upper conductor 20 is provided with an annular plug 20 'which is disposed in the upper conductor 20 and the sealing ring 99, a flange 101 which is also formed in the conductor 20 and a suitable tight fit between the sealing plug 20'. provide. The sealing ring 99 helps seal 36b when the syringe is pulled back properly · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · ·
In the embodiment shown in Fig. 12, the sealing flange 95 and the sealing ring 92 can both be used in the valve 10, forming an additional seal 36c. The seal 36c allows the syringe to be restored to its original condition very quickly after retracting, thereby incorporating the advantages of the seals 36a and 36b described above.
Figure 13 shows a further embodiment of the sealing element 36d, which seal 36d comprises a sealing cap 92, a sealing flange 96, and a side wall 150 formed essentially of annular rubber members 100 arranged so as to: they form a series in which the diameter of these annular rubber members 100 gradually decreases towards the sealing cap 92. The annular rubber members 100 are preferably solid in cross-section. These annular rubber members 100 can move quickly and easily when compressed or decompressed by the seal 3 6d and very advantageously cover the puncture member not shown.
36d. the seal is provided with a slit 11 which is formed in the sealing cap 92 and extends into the longitudinal axis of the valve 10. The sealing cap 92 is completely custom-made and ensures that the pre-slit 11 is properly closed and, after withdrawal of the syringe (not shown), the closure 36d. the gasket will return to its original condition. The seal 36d also includes an internal pressure-sensitive member 200 which forms a unit with the sealing cap 92. A 150 ol · · · «* · • ··· · * • · ···
At the proximal end of the 4 <<ι * 4fc ···· ·· song wall, there is an annular gap 102 between the pressure sensitive member 200 which is filled by the fluid in the cavity 98. This fluid is under pressure, for example when the valve 10 is connected to the patient, the patient's blood pressure is the pressure.
In the embodiment shown in Figure 14, the fluid is the blood of the patient, which flows through the through holes 34 at the nozzle 26 and fills the cavity 102. This fluid acts on the outer surface of the pressure sensitive member 200, closing the pre-slit 11 when the seal is in the decompressed state shown in Figures 14 and 19. The pressure of the liquid creates a high-pressure seal which prevents the liquid in the valve 10 from flowing out of the pre-slit 11. At the end, the pressure-sensitive member 200 has a semi-annular annular member 104 which may wear out, thereby extending the life of the entire seal 36d.
Preferably, this annular member 104 forms a unit with the pressure sensitive member 200 disposed along the inner surface and circumference of this pressure sensitive member 200 and a trough-shaped recess 204 on the outer upper surface of the seal 36d. The pressure-sensitive member 200 closes all openings in the seal 36d in the decompression state, thereby ensuring that the fluid 36 is sealed in the decompressed state. The pressure-sensitive member 200 allows the fluid to remain sealed to the valve even when subjected to very high pressures, which may occur frequently in medical applications, particularly when the valve 10 is connected to the patient's artery. The central portion of the pressure sensitive member 200 and the annular slot 102 are coaxial with the inlet 11a, which leads to the opening 11. The pressurized fluid fills the annular gap 102 and applies pressure to the pressure sensitive member 200 to close the aperture 11a. In the exemplary embodiment, the opening 11 is spaced from 0.5 to 0.75 inch from the proximal end of the sealing cap 92, but most preferably 0.1 inch.
Fig. 22 shows a slightly more detailed embodiment of the tip 32 according to the invention, which allows the seal to remain open. The tip 32 is provided with three ribs 210, 212 and 214 separated by lines a, b, c. Since the ribs 210, 212 and 214 are often very rough to be removed, they wear the seal 36d. To prevent this, the ribs 210, 212 and 214 separating the ribs 210, 212 and 214, or other connections are provided with recesses 220, 222, 224 so as to prevent this separating line from damaging the seal.
A further embodiment of the present invention comprising the seal 36d shown in FIG. 8 is a sectional view taken along the lines 19-21 of FIG. FIGS. In this exemplary embodiment, the inner wall 160 formed at the upper end of the conductor 20 is provided with at least one, but preferably a plurality of notches 107. These notches 107 are longitudinal, generally parallel to the axis of the valve 10, and are symmetrical. Each notch 107 has a flange 162 which engages the seal 36d when the seal 36d is compressed. These notches 107 essentially form a space into which the seal 36d can be pressed in and expanded upon application.
As can be clearly seen in Figure 8, the wall portion 181 at the proximal end of the conduit 20 is slightly tapered and the conical shape corresponds to the neck portion 48 of the syringe 46. According to ANSI standard, the taper is 0.006 inch / linear inch. The wall 182 of the syringe rests on the wall 181 and the neck 48 slides into the opening 25a and the seal 36d is pushed inward and forces the tip 32 of the puncture member 36 to penetrate the slot 11. The seal 36d expands under pressure and substantially fills the slots 107 completely. Some sections of the seal 36d are wedged between the edges 162 and the rest fill in the notches 107. When the fluid flows through the apertures 34 through the neck 48, air in the neck 48 is forced to escape from the neck 48 and to flow out of the valve 10 in the portion between the walls 181 and 182. In essence, it is thus ensured that a predetermined dose of medicament is delivered to the patient via valve 10. The fluid will thus flow through the through openings 34 and will not leak between valve 35d and wall 181 or between adjacent walls 181 and 182.
Figures 15, 16, 17 and 18 show a further embodiment of the sealing member 36e, 36f and 36g, which are substantially identical to seal 36a of Fig. 10, seal 36b of Fig. 11, and 12, respectively. 7c, the difference is that the sidewalls 150 use the annular rubber members 100 instead of the wall portions 94.
Various embodiments of the seal 36 operate in a manner similar to the seal 36 shown in FIG. 2 in the valve 10 of the present invention. Prior to use, it is desirable that the valve 10 be axially cut through the sealing cap 40 or 92 with a steel needle, thereby creating a gap 11 so that decompression and sealing after the piercing head 26 are cut more rapidly. The sealing elements are preferably made of a material which is repeatable for sealing purposes and prevents the liquid from flowing around and leaking out of the sealing material. The seal 36 must be capable of absorbing a downward force and subsequently bounce back to the position where it seals the valve. If a material that is too soft is used, it is very good at achieving a reproducible seal, but will not be able to bounce back properly when the valve is opened. A material that is too rigid, while providing sufficient spring force, does not seal well with good efficiency. Experiments have shown that it is desirable to form the seal 36 with a silicone-containing material having a hardness of from 30 to 70 Shore hardness and a material having a hardness of 40 to 50 Shore. For example, the cured and crosslinked silicone polymer is suitable for the manufacture of a seal according to the present invention manufactured by Wacker Silicone Corp., Adrian, Michigan, among others. In some exemplary embodiments, it is desirable that the gasket 36 has additional lubricity, as this helps the gasket to bounce back sufficiently quickly while the gasket itself is more effective. Dow Chemical Co. manufactures silicones that contain silicone oil that achieve this lubricity.
In general, the closure of the valve 10 is provided not only by the side walls of the seal 36 which directly cover the through holes 34, but also by the sealing cap 40 or sealing cap 92 which fills the proximal end of the cavity 98 and the opening 25a. Thus, the sealing caps 40 and 92 are preferably designed to be sufficiently thick to properly seal the opening 25a after the valve is closed. However, the sealing caps 40 and 92 must also be thin enough to ensure that they can easily return to their closed position. Preferably, the sealing caps 40 and 92 have a thickness of 0.075 to 0.5 inches, with the most preferred range being about 0.1 inch.
The valve of the present invention may also be manufactured in a sterile disposable form, and may be pumped out after use and thus discarded. As we have already mentioned, the device itself can be used many times. Because the valve 10 contains no needles, there is very little chance that the skin will puncture or damage the skin. Thus, the specifications that exist for disposable needles can then be disregarded. In practice, the present invention eliminates many of the needles used in the medical environment. By using the valve of the present invention, virtually any needle that is to be inserted into a patient can be almost omitted.
The operation of the valve according to the invention is as follows. The valve 10 of the present invention is a closed system for delivering or withdrawing a predetermined amount of fluid for patient access. The distal end of the valve 10 is connected to a patient, such as a fluid in a vein or artery thereof. Blood fills the filtrate, but seal 36d, for example, prevents blood from flowing out of valve 10. The end of the medical device or the medical device used to transfer fluid or the neck to the valve
8th The neck portion 48 is then aligned with the seal 36 and the seal 36 is pressed to such an extent that the tip 36 of the piercing member 24 fits through the seal to the fluid delivery end of the container or neck. A predetermined amount of medicament or fluid can then flow through the neck 18 into the valve 10 and from there to the patient. Since the neck portion 48 and the seal 36d are joined such that the tip 36 of the puncture member 24 is connected through the seal 36d, it is avoided that a dead space is formed between the neck portion 48 and the surface 40b. Liquid transfer is effected directly through valve 10 so that a predetermined amount of fluid flows from the syringe 46 to the patient, without any fluid remaining in the dead zone of valve 10. When the neck portion 48 is retracted and removed from the valve 10, the seal 36d returns to its decompressed state, closing the valve 10 and maintaining this decompression state in a fluid-tight manner, even after repeated use.
The valve of the present invention is provided in the most preferred embodiments, the drawings and the description of which are described in such detail as to enable one skilled in the art to design and use the valve of the present invention. Of course, other exemplary embodiments other than those illustrated may be provided to reflect the spirit of the invention.
25 sheets
Sheet 1 Sheet 2 Sheet 3 Sheet 4 Sheet 5 Sheet 6 Sheet 7 Sheet 8 Sheet 9 Sheet 10 Sheet 11 Sheet 12 Sheet 13 Sheet 14 Sheet 15 Sheet 16 Sheet 17 Sheet 18 Sheet 19 Sheet 20 Sheet 21 Sheet 22 Sheet 23 Sheet 24 Sheet 25
138 members in 26 offices
Priority claims1
| Document | Office | Kind | Date |
|---|---|---|---|
| 81307391 | United States of America | A |
Members138
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| CA2588574A1 | Canada | A1 | |
| WO9311828A1 | World Intellectual Property Organization (WIPO) | A1 | |
| MX9207380A | Mexico | A | |
| AU3233193A | Australia | A | |
| CN1077654A | China | A | |
| FI942929A | Finland | A | |
| FI942929A7 | Finland | A7 | |
| NO942318D0 | Norway | D0 | |
| NO942318L | Norway | L | |
| HU9401728D0 | Hungary | D0 | |
| CZ149294A3 | Czechia | A3 | |
| WO9503509A2 | World Intellectual Property Organization (WIPO) | A2 | |
| AU7373694A | Australia | A | |
| WO9503509A3 | World Intellectual Property Organization (WIPO) | A3 | |
| HUT67968AThis record | Hungary | A | |
| BG98816A | Bulgaria | A | |
| JPH07505064A | Japan | A | |
| SK74194A3 | Slovakia | A3 | |
| EP0681493A1 | European Patent Office (EPO) | A1 | |
| BR9206940A | Brazil | A | |
| CA2193702A1 | Canada | A1 | |
| WO9600053A1 | World Intellectual Property Organization (WIPO) | A1 | |
| WO9600107A1 | World Intellectual Property Organization (WIPO) | A1 | |
| AU2945495A | Australia | A | |
| AU2949595A | Australia | A | |
| RU94030466A | Russian Federation | A | |
| EP0712476A1 | European Patent Office (EPO) | A1 | |
| OA10067A | African Intellectual Property Organization (OAPI) | A | |
| AU6444196A | Australia | A | |
| JPH09500563A | Japan | A | |
| EP0771184A1 | European Patent Office (EPO) | A1 | |
| BG61386B1 | Bulgaria | B1 | |
| NZ246243A | New Zealand | A | |
| US5685866A | United States of America | A | |
| US5690612A | United States of America | A | |
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| US5928204A | United States of America | A | |
| AU3508399A | Australia | A | |
| EP0988871A2 | European Patent Office (EPO) | A2 | |
| NZ328241A | New Zealand | A | |
| EP0988871A3 | European Patent Office (EPO) | A3 | |
| EP0681493B1 | European Patent Office (EPO) | B1 | |
| AT194086T | Austria | T | |
| ATE194086T1 | Austria | T1 | |
| DE69231208D1 | Germany | D1 | |
| RU2154462C2 | Russian Federation | C2 | |
| ES2147748T3 | Spain | T3 | |
| US6132403A | United States of America | A | |
| DK0681493T3 | Denmark | T3 | |
| KR100273834B1 | Republic of Korea | B1 | |
| GR3034341T3 | Greece | T3 | |
| PT681493E | Portugal | E | |
| DE69231208T2 | Germany | T2 | |
| NZ334983A | New Zealand | A | |
| NO310805B1 | Norway | B1 | |
| AU744283B2 | Australia | B2 | |
| EP1181921A2 | European Patent Office (EPO) | A2 | |
| EP1181921A3 | European Patent Office (EPO) | A3 | |
| US2002032433A1 | United States of America | A1 | |
| AU3141702A | Australia | A | |
| EP0771184B1 | European Patent Office (EPO) | B1 | |
| AT223188T | Austria | T | |
| ATE223188T1 | Austria | T1 | |
| US2002138047A1 | United States of America | A1 | |
| NZ507258A | New Zealand | A | |
| FI109661B | Finland | B | |
| US2002143301A1 | United States of America | A1 | |
| DE69528063D1 | Germany | D1 | |
| HK1045454A1 | Hong Kong, China | A1 | |
| PT771184E | Portugal | E | |
| DK0771184T3 | Denmark | T3 | |
| ES2181784T3 | Spain | T3 | |
| US6572592B1 | United States of America | B1 | |
| DE69528063T2 | Germany | T2 | |
| US6599273B1 | United States of America | B1 | |
| CN1443579A | China | A | |
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| US6682509B2 | United States of America | B2 | |
| EP0988871B1 | European Patent Office (EPO) | B1 | |
| AT262361T | Austria | T | |
| ATE262361T1 | Austria | T1 | |
| US2004073174A1 | United States of America | A1 | |
| DE69233329D1 | Germany | D1 | |
| AU2004201518A1 | Australia | A1 | |
| DK0988871T3 | Denmark | T3 | |
| HK1059231A1 | Hong Kong, China | A1 | |
| US6758833B2 | United States of America | B2 | |
| PT988871E | Portugal | E | |
| DE69233329T2 | Germany | T2 |
1 legal event, as the office reported them to INPADOC
Events
| Event | Code | |
|---|---|---|
| Temporary prot. cancelled due to non-payment of feeDFD9 | DFD9 |
Numbers
- Application
- 9401728
Titles
- English
- MEDICAL SYRINGE
Classification
- CPC, 11
- A61M5/14
- A61J2200/10
- A61M39/045
- A61M39/26
- A61M2039/262
- A61M2205/32
- A61M2205/583
- A61M2205/6063
- F21K2/00
- Y10S604/905
- A61M2039/267
- IPC, 11
- A61M5 14
- A61M5 168
- A61M5 162
- A61M25 16
- A61M39 00
- A61M39 04
- A61M39 14
- A61M39 22
- A61M39 26
- F16K27 00
- F21K2 00
