Infusion set

TECHNICAL FIELD [0001] The object of the invention relates to the full range of use of infusion sets, and more particularly to infusion sets with interchangeable injection needles.

TECHNICAL DESCRIPTION [0002] Subcutaneous injection is a standard method of administering a drug to the inside of a patient's body. To enable multiple or continuous subcutaneous drug injections, injection ports (attachments) are often used. These injection ports pass through the skin and can remain in place for up to several days. Currently, the main application of such injection ports / ports is to provide continuous delivery of drugs, such as insulin, using portable pumps worn by the patient. When using a portable pump, the injection port is connected to the pump via a fluid delivery line. Another application of the subcutaneous injection port is to allow multiple injections (infusions) of drugs into the patient's body without the need for repeated puncturing of his skin.

[0003] Subcutaneous injection ports usually require sharp and strong needles to pierce the patient's skin when initially placed on the patient's body. However, if the needle is left in the place of passage through the skin for drug administration, after a period of one or two days, the presence of the needle becomes an uncomfortable situation for the patient. In order to solve this problem, infusion sets having interchangeable needles and a soft plastic cannula for mounting inside the patient's body were developed. However, such sets have many disadvantages. In this situation, there is a need for improved infusion sets that are less spatial, less susceptible to contamination, more convenient for the patient, and easier to use.

[0004] US 2002/0095138 discloses a system for the subcutaneous introduction of fluid from a portable reservoir into a patient. The main assembly of this system includes a rotating element. When the rotatable element assumes a vertical position relative to the main assembly, then the main assembly allows the holder and needle to be attached to the patient's body, but without the possibility of infusing fluid into the patient's body. After removing the handle and the needle, it becomes possible to connect the drug delivery tube to the rotating part, which then can turn down to a longitudinal position relative to the adjacent skin of the patient and thus allow infusion.

[0005] The patent specification of WIPO WO 02/070037 A2 discloses the construction of an infusion node assembly. The infusion node consists of a central seat and a housing that can rotate relative to the seat during infusion.

[0006] The WIPO patent specification WO 02/081012 A2 discloses a system for connecting a fluid supply line to a cannula. This system consists of a base body and a plug. The protruding edge of the plug is first attached to the base body, then the plug is inclined downwards to the point of rotation defined by the connection itself, in which position it is possible to flow fluid through the plug up to the base body.

[0007] US-A-5,545,143 discloses an injection port syndrome for subcutaneous drug delivery. This assembly consists of a molded part being a body having a soft cannula protruding down from the flat surface of the bottom. In this embodiment, for insertion of the cannula through the skin, the application is a metal needle that pierces the septum and passes through the lumen in the soft cannula.

DISCLOSURE OF THE INVENTION [0008] One of the solutions of the invention is to provide an infusion set comprising a base element, a guide cap, and an infusion head. A preferred embodiment of the invention is that the base element includes both a connection on one side thereof and a soft cannula protruding on the other side of the base element. The connection configuration ensures that it is a communication channel with a cannula for fluid flow. According to the invention, the connection also has a baffle adapted to seal it against unintentional fluid flow. The guide cap is adapted to be mounted on the base element and has a needle adapted to be guided through the septum and said soft cannula in assembled form. The infusion head also has a channel adapted to receive / connect an elongated flexible tube / conduit. The infusion head also contains a hard cannula adapted to be connected through the septum and placed in a soft cannula thereby providing a fluid connection with said channel.

[0009] According to the essence of the invention, the base element has a round shape, and a port / connection that is preferably made in the form of a cylindrical part protruding on one side of the base element. The guide cap is preferably in the shape of a spatial cylindrical dome protruding from the other side of the guide cap, which is positioned coaxially with the guide needle. The infusion head is preferably made of a spatial cylindrical dome protruding from the other side of the infusion head, which is positioned coaxially with the hard cannula. On the contrary, the first side of the infusion head preferably has a convex shape, and when the infusion head is adapted to rotate relative to the base element when the two parts i.e. the infusion head and the base element are joined together.

[0010] The base is best when it is surrounded by a rim adapted for connection and for fixing an outer element thereon. The cannula protrudes down from the first side of said base; and the adhesive layer is attached to the first side of the base. The adhesive layer has a second side coated with an adhesive substance. The connection / port having a substantially cylindrical shape protrudes upwards from the other side of said base. The connection / port contains a partition configured to ensure the possibility of fluid flow through the port. The fluid flow channel is best when it has the form of a gap passing through the septum, but alternatively the flow channel may be formed by its piercing with a needle or other similar instrument. According to the method disclosed for the infusion set in the present invention, the base element is adapted to be attached to the patient's skin, and the needle and cannula are passed through the patient's skin. The guide cap is disconnected and the needle is removed from the base element. The infusion head is then mounted on the base element in such a way that the cannula of the slide cap is in a state of fluid communication with the cannula of the base, and the guide cap is provided with the ability to rotate with respect to the base element.

BRIEF DESCRIPTION OF THE DRAWINGS [0011] After disclosing a summary of the general nature of the invention, certain preferred uses and modifications will become apparent to those skilled in the art through a detailed description to which reference is made in accordance with the following drawings, where: Figure. 1 is a perspective exploded view of an infusion set and a support assembly having the features and benefits desired by the invention. Figure 2 is a plan view of the slide cap disclosed in Fig.

1.

Figure 3 is a sectional view of the slide cap disclosed in Figure 1 taken along axis 3 - 3.

Figure 4 is a cross-sectional view of the slide cap disclosed in Figure 1, taken along axis 4 - 4.

Figure 5 is a perspective view of the base element disclosed in Figure 1.

Figure 6 is a sectional view of the base element disclosed in Figure 4.

Figure 7 is a perspective view of the guide assembled with the base element.

Figure 8 is a cross-sectional view of the assembled assembly disclosed in Figure 7, taken along axes 8 - 8.

Figure 9 is a cross-sectional view of the assembled assembly disclosed in Figure 7, taken along axis 9 - 9.

Figure 10 is a top view of an infusion head that has the features and benefits desired by the invention.

Figure 11 is a cross-sectional view of the infusion head disclosed in Figure 10, taken along axis 11 - 11

Figure 12 is a perspective view of the assembled infusion head with a base element.

Figure 13 is a cross-sectional view of the assembled assembly disclosed in Figure 12, taken along axis 13 - 13.

Figure 14 is a cross-sectional view of the assembled assembly disclosed in Figure 12, taken along axes 14-14.

DETAILED EXAMPLES OF SOLUTIONS OF THE INVENTION [0012] An infusion set having desirable features and advantageous properties will now be described with reference to the disclosed drawings. Although the following description provides the use of the invention in the context of using an infusion set with connection to an insulin pump, experienced medical practitioners will be able to appreciate that the properties of the infusion set disclosed in the present invention can provide beneficial solutions for use in other applications. similar applications.

[0013] The infusion set disclosed in Figs. 1-14 and presented in the present general account consists of a pedestal assembly 20 adapted to mount on it a removable guide assembly 30 and an infusion assembly 40 (see Fig. 13).

[0014] Figure 1 illustrates a perspective exploded view of the components of the pedestal assembly 20 and the guide assembly 30. The pedestal assembly 20 is designed to be placed on the patient's skin using the adhesive layer 50 so as to maintain a soft cannula 52 penetrating the patient's body. and provide affixing of the infusion head 54 (see Fig. 10-14) to the pedestal assembly 20 to deliver liquid through the cannula 52 into the patient's body. The base unit 20 preferably consists of a base element 60 with a soft cannula 52 protruding from the first side of the base element 60, the port / connector 62 protruding from the other side of the base element 60, the adhesive layer 50 attached to the second side of the base element 60.

[0015] The guide assembly 30 typically has a configuration allowing assembly of the disassembled base unit 20 to insert the soft cannula 52 through the patient's skin up to the required depth in the subcutaneous adipose tissue.

[0016] Figures 1-4 illustrate a solution for a guide assembly 30 consisting of a guide 64 and a guide needle 66 coming down from the cap 64. For the figure shown, the guide 64 is typically in the shape of a canopy, and has a portion with a holder 72, a portion adjacent to the port / port 74, a portion adjacent to the base 76, releasing catches 100.

[0017] As disclosed in the drawing, the portion with the handle 72 typically consists of a flange with a section for securing the needle 82 passing through the collar portion of the collar.

72. In one embodiment, the slide cap 64 is molded with a needle clamp portion 82 including a channel in which the guide needle 66 can then be inserted and attached. Alternatively, the guide needle 66 can be pushed into the material from which the slide cap 64 is made by applying various molding / forming methods available to an experienced technician. According to another embodiment of the invention, the needle attachment portion 82 extends partially through the recess 84 in the portion adjacent to the port / port 74 so as to provide additional support on the longer needle section 66. The length of the needle-supporting portion (i.e., the part of the needle length that is located inside the tubular holding needle 82) may have different values ​​depending on the length of the needles used. For example,

3/16 inch to about 5/16 inch.

[0018] The guide needles may be used with a large variety of sizes, as required by the individual cannula or application. For example, needles with a length of about 0.5 inches to about 2 inches or more may be used. In further alternative solutions, also needles with lengths extending beyond the given length range may be used. In addition, the guide needle may be fixed, or may have a hollow inner slot as required. [0019] The portion with the holder 72 on the slide guide 64 according to the arrangement, as in the drawing, comprises a substantially flat portion extending upwardly from the spatial part of the cap 64. The portion with the handle 72 preferably has a substantially large surface area, that the patient or the person providing the medical aid can easily grasp the guide rod 64 for attaching it to the base 60 and to easily insert the needle 66 into the patient's body. For example, as shown, the handle portion may extend across a substantial portion of the diameter of the slide cap. The handle section 72 may also extend upwardly from the canopy cap by about 0.2 inch to 1 inch. For one advantageous solution, a portion of the handle 72 protrudes about a inch above the top of the guide cap 64. The experienced user will appreciate that the portion of the handle 72 may be shaped and sized in any way, according to specific requirements. Alternatively, the guide cap 30 may be held using the release tabs 100 or any other convenient portion during the insertion of the needle,

[0020] According to the disclosure in figure 2, the interface part of the port / connection is preferably provided that it comprises a cylindrical portion configured to closely enclose the port / connection 62 of the base element 60 in the combined position. The tubular wall 86 of the adjoining port / port 74 is typically constructed to provide contact with the top surface 92 of the base portion 60, which method will beyjaśniony w dalszej części opisu. Ścisłe spasowanie pomiędzy portem/przyłączem 62 i rurkowatą ścianką 86 na części przylegającej portu/przyłącza 74 nasadki prowadnika 64 w sposób korzystny zapewnia najmniejszy możliwy ruch podstawki 60 w stosunku do nasadki prowadnika 64 podczas wprowadzania igły 66 i cewnika 52 do ciała pacjenta.

[0021] Zgodnie z rozwiązaniem wynalazku ujawnionym na rysunku, część przylegająca do podstawki 76 nasadki prowadnika 64 zazwyczaj zawiera parę skrzydełek 98 wysuniętych do dołu od nasadki. Skrzydełka 98 najlepiej gdy posiadają nóżki zapadkowe 94 przystosowane do połączenia z obrzeżem 96 części bazowej 60 (rysunek Fig. 6). Nóżki zapadkowe 94 są zazwyczaj skonfigurowane tak, żeby przymocować nasadkę prowadnika do tarczy części bazowej 60. Wysokość „h” pomiędzy wierzchołkiem nóżki zapadkowej 94 i najniższym punktem rurkowatej ścianki 86 na części portu/przyłącza 74 jest zwykle wybrana tak, aby korespondowała z wymiarami części bazowej 60, oraz w celu zapewnienia bezpiecznego spasowania pomiędzy złożonymi częściami 20 i 30 tak, jak to zostanie wyjaśnione w dalszej części opisu patentowego. W alternatywnym rozwiązaniu wynalazku, nóżki zapadkowe 94 mogą zostać pominięte, i wtedy nasadka prowadnika może pozostać w ustalonym położeniu roboczym względem zespołu podstawki 20 przy wykorzystaniu innych dostępnych sposobów. Dla przykładu, port/przyłącze 62 i część przylegająca portu 74 mogą zamiennie być w wykonaniu gwintowanym tak, żeby nasadka prowadnika mogła być przykręcona do części bazowej.

[0022] Zgodnie z rozwiązaniem wynalazku ujawnionym na rysunku, nasadka prowadnika 64 jest zwykle okrągła (patrz rysunek Fig. 2). Jak ujawniono na rysunku Fig. 2, para zaczepów zwalniających 100 jest umiejscowiona po przeciwnych stronach okrągłej nasadki 64 w obszarze nóżek zapadkowych 94 w sposób, który umożliwia zwolnienie nasadki prowadnika 64 od połączenia z elementem bazowym zwalniające 100 przez przyłożenie siły w kierunku wskazanym przez strzałki 102, najlepiej przez wciśnięcie zaczepów zwalniających 100 kciukiem i palcem środkowym. W rozwiązaniu wynalazku zilustrowanym na rysunkach Fig. 2-4 i 8, zaczepy zwalniające 100 posiadają pionowe części, które mogą być niezależnie uformowane zgodnie z kształtem czaszy nasadki prowadnika 64. Alternatywnie, pionowo rozchodzące się części mogą stanowić oddzielne sekcje, które mogą być także oddzielnie wykonane z części nasadki prowadnika i zamocowane w jakikolwiek inny stosowny sposób. W praktycznym rozwiązaniu, zastosowanie siły wzdłuż strzałek 102 wywoła moment zginający w części wewnętrznej pionowo rozchodzących się części i czaszy nasadki. Ten moment zginający powoduje, że obszar skrzydełek 98 nasadki prowadnika 64 ulega ugięciu na zewnątrz , zwalniając w ten sposób nóżki zapadkowe 94 i rozłączając prowadnik od części bazowej 60.

[0023] Kolejne alternatywne rozwiązanie wynalazku stanowi, że zaczepy zwalniające 100 mogą posiadać wypukłe występy, wklęsłe zagłębienia, lub wykonania w innych formach lub profilach tak, aby zapewnić kształt pozwalający na odkształcenie nasadki prowadnika, które powoduje odłączenie nasadki prowadnika 64 od elementu bazowego 60. Pokazane na rysunku zaczepy zwalniające 100 korzystnie umożliwiają użytkownikowi uchwycenie nasadki prowadnika 30 w jego/jej palcach bez potrzeby równoczesnego uchwycenia obrzeża 96 elementu bazowego 60, czyniąc odłączanie nasadki prowadnika 64 od elementu bazowego 60 znacznie łatwiejszym. Zamiennie, podczas montażu lub demontażu nasadki z elementem bazowym 60 może być również używane oddzielne narzędzie do uchwycenia nasadki prowadnika i/lub głowicy infuzyjnej 54.

[0024] Nasadka prowadnika, najlepiej gdy jest wykonana jako wypraska wykonana w procesie wtrysku plastikowego materiału stosowanego do użytku w aplikacjach medycznych. W jednym z korzystnych rozwiązań wynalazku, nasadka prowadnika 64 jest wykonana z bio-kompatybilnego tworzywa ABS, i posiada ścianki o grubości „t” około 0.030 cala +/- 0.005 cala. Inne alternatywne rozwiązanie zakłada, że nasadka prowadnika 64 może być wykonana z innych bio-kompatybilnych materiałów takich jak poliwęglany w każdym dowolnym rozmiarze, zgodnie ze specyficznymi wymaganiami.

[0025] Jak to zostało ujawnione na rysunku Fig. 3, nasadka prowadnika 64 może również posiadać żeberka 104 rozchodzące się promieniście od rurkowatej ścianki 86 części przyłączeniowej portu/przyłącza 74. Żeberka 104 mogą być wykonane w dowolnym rozmiarze i ilości tak, jak to jest wymagane żeby uzyskać dodatkową sztywność wymaganą do uzyskania połączenia pomiędzy rurkowatą ścianką i korpusem nasadki prowadnika.

[0026] Przykład rozwiązania wynalazku dla zespołu podstawki 20 zostanie teraz wyjaśniony przez rysunki Fig. 1, 5 i 6. W oparciu o pokazane tam szczegóły, zespół podstawki 20 składa się z elementu bazowego 60 i portu/przyłącza 62 wychodzącego ku górze i z miękkiej kaniuli 52 wychodzącej w dół z krążka 60. W zilustrowanym rozwiązaniu, element bazowy 60 jest pokazany jako zasadniczo okrągły krążek; jednakże w alternatywnych rozwiązaniach, krążek może również posiadać kształt elipsy lub wielokąta, etc. Dla okrągłego elementu bazowego 60 , jak ujawniono na rysunku, korzyścią rozwiązania jest możliwość obrotu nasadki prowadnika 64 i/lub głowicy infuzyjnej 54 na nim zamocowanych, wokół osi głównej elementu bazowego 60.

[0027] Zgodnie z rysunkiem, ujawniony element bazowy 60 składa się z obrzeża 96 otaczającego element bazowy 60 posiadający kształt dysku. Obrzeże 96 jest zazwyczaj tak skonfigurowane, żeby przyjąć/współpracować z nóżkami zapadkowymi nasadki prowadnika 64 i/lub głowicy infuzyjnej 54 do ustalenie pozycji elementów głowicy (64 lub 54) na elemencie bazowym 60. Jak widać na rysunku Fig. 6, obrzeże 96 elementu bazowego 60 może posiadać wycięcie 110 w celu uzyskania prześwitu potrzebnego do zaczepu dla nóżek zapadkowych 94. Obrzeże 96 części bazowej 60 może być wykonane również w kształcie sfazowanej krawędzi 112 dla ułatwienia połączenia elementów głowicy 54 i 64 z elementem bazowym 60, w sytuacji, gdy głowica jest wciskana osiowo w dół w kierunku elementu bazowego 60, jak to zostanie opisane w dalszej części opisu.

[0028] Odnosząc się szczegółowo do rysunku Fig. 6, przykładem rozwiązania wynalazku dla elementu bazowego 60 jest jego adaptacja, w której element posiada bardzo niski profil. Dla przykładu, w niektórych rozwiązaniach, całkowita wysokość „q” może się mieścić w przedziale pomiędzy ok. 0,15 cala i ok. 0,25 cala. Dla innego korzystnego rozwiązania, całkowita wysokość „q” elementu bazowego 60 wynosi około 0,20 cala.

[0029] Zgodnie z innym korzystnym rozwiązaniem wynalazku, dystans „d” (patrz Rysunek Fig. 6) pomiędzy dolną powierzchnią obrzeża 96 i górną powierzchnią 92 elementu bazowego 60 jest dobrany tak, żeby korespondował z wysokością „h” pomiędzy górną krawędzią nóżki zapadkowej 94 i dolną krawędzią rurkowatej ścianki 86 części przylegającej portu/przyłącza na nasadce prowadnika 64 (jak omówiono powyżej w odniesieniu do rysunku Fig. 3) oraz głowicą infuzyjną (jak to zostanie omówione poniżej w odniesieniu do rysunku Fig. 11). W kolejnym wykonaniu wynalazku, odległości „d” i „h” są w sposób istotny takie same, w ten sposób zapewniając istotnie sztywne połączenie pomiędzy głowicą (64 lub 54) a elementem bazowym 60. Zamiennie, wymiar „h” może być większy niż wymiar „d” ażeby zapewnić luźniejsze połączenie pomiędzy głowicą (64 lub 54) a elementem bazowym 60.

[0030] Z faktu wykonania luźnego lub ścisłego połączenia pomiędzy elementem bazowym 60 a elementem czaszy nasadki (64 lub 54) wynikają pewne korzyści. Dla przykładu, ścisłe połączenie pomiędzy elementem bazowym 60 i nasadką prowadnika 64 będzie asystowało igle 66 podczas kontrolowanego wsuwania igły 66 i miękkiej kaniuli 52 poprzez skórę pacjenta. Z drugiej strony, luźniejsze ale bezpieczne połączenie pomiędzy elementem bazowym i głowicą infuzyjną 54 pozwoli na obrót i poruszanie głowicy infuzyjnej 54 względem elementu bazowego bez przekazywania istotnego skrętnego naprężenia na element bazowy 60 i na pacjenta.

[0031] Jak ujawniono na rysunku Fig. 6, element bazowy 60 zawiera kanalik przepływowy płynu przechodzącą od wierzchołka 114 portu/przyłącza 62 poprzez miękka kaniulę 52 wychodzącą z dolnej powierzchni 118 elementu bazowego 60. Część środkowa kanalika przepływowego najlepiej gdy posiada istotną sekcję w kształcie stożka 120 z rurkową, dolną sekcją 122. Zgodnie z jednym z przykładów rozwiązania wynalazku, stożkowa wkładka 124 może zostać zastosowana do pozycjonowania wewnętrznej powierzchni stożkowej sekcji 120. Wkładka 124, najlepiej gdy jest wykonana ze sztywnego materiału, takiego jak metal, aby ochraniać ściankę sekcji stożkowej 120 podczas wsuwania igły prowadnika 66 (rysunki Fig. 1 i 3). Wkładka 124 ochrania ściankę stożkowej sekcji 120 przed nacięciami i/lub generowaniem luźnych fragmentów oderwanych od ścianki i możliwością ich dostania się do strumienia infuzyjnego.

[0032] Miękka kaniula 52 wychodząca z elementu bazowego 60 może zawierać jakikolwiek materiał uznany za nadający się do zastosowania jako przekrój ścieżki przepływu płynu implantowany do ciała pacjenta. Zestaw infuzyjny może być oferowany wraz z miękkimi kaniulami posiadającymi rozmaite długości aby przystosować zestaw do pożądanych głębokości wprowadzenia kaniuli do ciała pacjenta. Dla doświadczonych praktyków medycznych jest to zrozumiałe, że wiele wykonań miękkiej kaniuli 52 najlepiej gdy jest umieszczanych w podskórnej tkance tłuszczowej pacjenta. Tak więc, kaniule o różnych długościach są pomocne w zastosowaniu prezentowanego zestawu infuzyjnego dla pacjentów o różnej, mniejszej lub większej, podskórnej tkance tłuszczowej. Dla przykładu, miękkie kaniule mogą być produkowane o długościach od ok. % cala do ok. 2 cali. W zależności od zamierzonego użycia, jest możliwość zastosowania miękkich kaniuli o długościach przekraczających podany zakres.

[0033] Rysunki Fig. 1, 5 i 6 ilustrują rozwiązanie wynalazku, w którym kaniula 52 wystaje z dolnej powierzchni 118 części bazowej 60 pod kątem o istotnym odchyleniu. W alternatywnym wykonaniu, kaniula 52 może być ukształtowana tak, że kąt pod którym wystaje ona z elementu bazowego jest istotnie mniejszy niż 90°. [0034] W innym alternatywnym rozwiązaniu, miękka kaniula 52 może być zamieniona przez dość twardą kaniulę lub igłę hypodermiczną, która także może być brana pod uwagę. Tego typu twarda kaniula lub igła mogą również być użyte przy zastosowaniu dowolnego kąta pochylenia względem powierzchni dolnej 118 elementu bazowego 60 jeśli zachodzi taka potrzeba.

[0035] Zgodnie z kolejnym rozwiązaniem, miękka kaniula 52 może być przymocowana do stożkowatej wkładki 124, i zespół kaniula-wkładka może być wsuwany do sekcji stożkowej 122 elementu bazowego 60. W alternatywnym rozwiązaniu, miękka kaniula 52 może zostać umieszczona bezpośrednio na elemencie bazowym przez zamocowanie jej na występie z dolnej powierzchni 118 elementu bazowego 60, a dokładnie do powierzchni wewnętrznej lub zewnętrznej rurkowatego dolnego odcinka sekcji 122 części stożkowej.

[0036] Jak ujawniono na rysunkach Fig. 1, 5, i 6, port/przyłącze 62 wystające z części bazowej 60 w sposób korzystny zawiera samouszczelniającą się przegrodę 130 umieszczoną we wgłębieniu 132 ponad sekcją stożkową 120 portu/złącza 62. Przegroda 130 najlepiej gdy jest umieszczona w wierzchołku portu/przyłącza 62 lub jego górnej części tak, żeby uzyskać wyraźnie dostępną powierzchnię do odkażania przy użyciu antyseptycznych tamponów w celu utrzymania przegrody wolnej od skażenia bakteryjnego i innych nieczystości. Umieszczenie przegrody ponad stożkową sekcją 120 pomaga w utrzymaniu jej sterylnej czystości. W zastosowaniu jak na rysunku, przegroda 130 w sposób korzystny posiada szczelinę 134 kształtującą strugę płynu przepływającego przez przegrodę 130. Pomimo tego, że zaprezentowana na rysunku szczelina 134 posiada kształt prostoliniowy, w alternatywnych rozwiązaniach, szczelina 134 może posiadać kształt okrągły, skrzyżowany, lub ukształtowany w inny sposób byle tylko dostarczyć określony przepływ płynu przez przegrodę 130. W kolejnych alternatywnych rozwiązaniach uformowana szczelina 134 może zostać pominięta, i przegroda 130 może zostać przekłuta igłą lub innym ostrym przedmiotem tak, żeby zapewnić ścieżkę przepływu płynu przez przegrodę 130.

[0037] W celu stworzenia samo-uszczelniającego się kanalika podawania płynu, przegroda 114 jest zwykle wykonana z istotnie odpornego materiału z wymuszonym położeniem w uszczelnionej pozycji. W jednym z rozwiązań wynalazku, przegroda 114 jest wykonana jako wypraska w kształcie dysku z silikonu, poliuretanu lub innego właściwego materiału, który może zostać zamocowany do portu/przyłącza 62. Zamocowanie przegrody 114 do portu/przyłącza 62 może być przeprowadzone przez użycie każdego dogodnego materiału przylepnego, spoiwa lub innego sposobu mocowania takiego jak zgrzewanie termiczne, zgrzewanie ultradźwiękami, itp. W alternatywnym rozwiązaniu, dogodny odporny materiał taki jak silikon, poliuretan, lub inny dogodny materiał elastomerowy może być uformowany wewnątrz wgłębienia 132 na wierzchu portu/przyłącza 62 (rysunek Fig. 6). W kolejnych rozwiązaniach wynalazku, przegroda 114 może być zamieniona przez każdy z szerokiego wyboru mechanicznych zaworów jednokierunkowych lub innych uszczelnień skonfigurowanych tak, żeby zapewnić rozłączalne uszczelnienie kanalika przepływowego płynu. W innym rozwiązaniu, przegroda 114 i korpus elementu bazowego 60 mogą oba być nierozłącznie uformowane z tego samego odpornego materiału.

[0038] Zgodnie z kolejnym rozwiązaniem wynalazku, jak to ujawniono na rysunku Fig. 8, przegroda 114 jest wypraską w kształcie dysku z istotnie odpornego materiału, który jest zamocowany na porcie/przyłączu 62 przez zastosowanie termicznego spęczania łączonych części. Zgodnie z rysunkiem, część ścianki portu/przyłącza 136 jest tak wykonana, że wystaje ponad poziom przegrody 114 i otacza wgłębienie 132, w którym przegroda 144 jest umieszczona. Ścianka portu/przyłącza 136 podlega termicznemu spęcznieniu przez delikatne podgrzewanie materiału ścianki 136 do temperatury poniżej punktu stopienia, ale wystarczająco wysokiej do zmiękczenia materiału ścianki. Po osiągnięciu punktu w którym materiał ścianki portu/przyłącza 136 ulega mięknięciu, część ta może być odkształcona radialnie, lekko ku środkowi tak, że następnie powoduje uwięzienie (zakleszczenie) przegrody 114 we wgłębieniu 132 portu /przyłącza 62. Procedura termicznego spęczniania może być przeprowadzana jednorodnie dookoła obwodu portu, lub w sposób interwałowy dookoła ścianki 136. Doświadczony praktyk medyczny zauwaIt is understood that other alternative methods for fixing the partition within the cavity 132 can also be used, such as bonding, gluing, welding, etc. As shown above.

[0039] As disclosed in Figure 6, the tubular bottom portion 112 of the conical portion 120 is surrounded by a spherical ring 138 configured to allow the needle shield 140 to be attached to the conical section 120. (See Figures 8 and 9). In the embodiment illustrated in Figs. 7 and 8, the needle cover 140 consists of a tubular section with length and stiffness sufficient that no sharp tip of the needle protrudes from the sheath 140. The needle shield 140 may include any suitable material and have a suitable desired design. For example, in one embodiment of the invention, the needle cover 140 has a portion made of a vinyl tube 144 that protrudes from about 1/8 inch to about% inch beyond the tip of the needle in a folded position as shown in Figure 8. In an alternative solution, the spherical ring 138 can be omitted and then the needle shield 140 can be secured above the needle 66 using other methods such as tight fitting of the high friction surface around the needle 66 or by providing the needle shield as part of the infusion set package. In some embodiments, as illustrated in Figures 3 and 4, the needle shield 140 may be structured to allow direct attachment to the slide cap 64 to at least extend the distance 146 within a range between 1/16 inch to 1/8 inch or more beyond tip of the needle. In another alternative embodiment, the provision of a needle casing can allow it to be secured to the ratchet legs 94 of the guide 64 when the guide cap 64 is detached from the base member 60. such as tight fitting of the surface with a high coefficient of friction around the needle 66 or by providing a needle casing as part of an infusion set package. In some embodiments, as illustrated in Figures 3 and 4, the needle shield 140 may be structured to allow direct attachment to the slide cap 64 to at least extend the distance 146 within a range between 1/16 inch to 1/8 inch or more beyond tip of the needle. In another alternative embodiment, the provision of a needle casing can allow it to be secured to the ratchet legs 94 of the guide 64 when the guide cap 64 is detached from the base member 60. such as tight fitting of the surface with a high coefficient of friction around the needle 66 or by providing a needle casing as part of an infusion set package. In some embodiments, as illustrated in Figures 3 and 4, the needle shield 140 may be structured to allow direct attachment to the slide cap 64 to at least extend the distance 146 within a range between 1/16 inch to 1/8 inch or more beyond tip of the needle. In another alternative embodiment, the provision of a needle casing can allow it to be secured to the ratchet legs 94 of the guide 64 when the guide cap 64 is detached from the base member 60. as illustrated in Figures 3 and 4, the needle shield 140 may be structured to allow direct attachment to the slide cap 64 to at least extend the distance 146 to a range between 1/16 inch to 1/8 inch or more beyond the tip of the needle. In another alternative embodiment, the provision of a needle casing can allow it to be secured to the ratchet legs 94 of the guide 64 when the guide cap 64 is detached from the base member 60. as illustrated in Figures 3 and 4, the needle shield 140 may be structured to allow direct attachment to the slide cap 64 to at least extend the distance 146 to a range between 1/16 inch to 1/8 inch or more beyond the tip of the needle. In another alternative embodiment, the provision of a needle casing can allow it to be secured to the ratchet legs 94 of the guide 64 when the guide cap 64 is detached from the base member 60.

If required, the surrounding area 138 of the base element 60 may be formed with a ring 142 to facilitate disengagement of the base element from the mold half during the injection process. It is obvious to experienced technicians that it is often desirable that the part obtained by injection into the mold remains in one half of the mold until the mold half is moved to the place where the formed part is dropped into the receiving container at which time the part can be released from the form through ejectors. In the absence of the ring 142 in the solution, the injection molded base element 60 may prematurely fall out of the mold. It should be noted here that the base element 60 does not necessarily have to be made by injection molding,

[0041] According to another embodiment of the invention, the adhesive layer 50, such as shown in Fig. 1, can be attached to the bottom surface of the base element 60. The adhesive layer 50 is generally made to allow the base member 60 to be attached to the skin. the patient in a way that will be explained later in the description. Adhesive layer 50 is usually covered by a protective layer 150 to protect the adhesive side 152 of the adhesive layer against dirt, dust and other impurities that can reduce adhesion and adhesion of the adhesive side 152 and thereby impede effective adhesion to the patient's body, and these impurities additionally they pose a risk of infection at the injection site. The adhesive layer 50 may be attached to the bottom surface 18 of the base element 60 by any suitable fastening material or other method appropriate to the process. For example, the adhesive layer may be attached to the base element with glue or other adhesive. Alternatively, the adhesive layer 50 may be attached to the base element 60 by thermal welding, ultrasonic welding, or using another convenient method. Alternatively, the function of obtaining adhesion of the base element 60 to the patient's skin can be obtained using other means known to those skilled in the art. the adhesive layer 50 may be attached to the base element 60 by thermal welding, ultrasonic welding, or using another convenient method. Alternatively, the function of obtaining adhesion of the base element 60 to the patient's skin can be obtained using other means known to those skilled in the art. the adhesive layer 50 may be attached to the base element 60 by thermal welding, ultrasonic welding, or using another convenient method. Alternatively, the function of obtaining adhesion of the base element 60 to the patient's skin can be obtained using other means known to those skilled in the art.

[0042] Figures 7-9 disclose a method for terminating the invention for a guide assembly 30 attached to a base unit 20. As shown, the guide rod 64 is preferably attached to the base member 60 via ratchet legs 94 latching against a base member shoulder 60 Due to the releasable way of attaching the guide cap to the base element 60, the needle 66 is pre-attached within the cannula 52 to provide a rigid puncture surface during the process of inserting the cannula 52 into the patient's body. In case the guide rod 64 or the needle 66 are not connected to the base element 60, then the guide cap 64 and the base element 60 may become detachable or misaligned when placed in the patient's body. Such a situation may create a need to repeat the puncture, and cause unnecessary pain and discomfort to the patient. In the illustrated embodiment, the connection of the slide cap with the base member 60 allows these parts to be pressed both at a time towards the body of the patient, preferably by a single, rapid movement. The cylindrical wall 86 of the port connector part 74 is also preferably connected to the upper surface 92 of the base portion 60.

[0043] The portion adjacent to the port / port 86 of the guide cap preferably is adapted to receive / receive the port 62 of the base member 60. This assures a tight fit between the guide cap 64 and the base element 60. This tight fit can help secure the base element. by rocking or making other unwanted movements with respect to the guide rod 64. The same convenient features may also be advantageous considering their use for the guide rod 54, as discussed in the following. A preferred solution is that the inner diameter of the adjacent port / port portion 74 is about 0.025 inches to about 0.1 inches more than the diameter of the base element port 62. Depending on the desired use, in an alternative embodiment, the inner diameter may be outside this range.

[0044] With reference to Figures 10-14, a preferred embodiment of an infusion assembly 40 adapted to be assembled with the base element 60 will now be discussed. As illustrated, the infusion head 54 can be shaped to be connected to the base element 60 in a similar manner to that described above for the guide wire 64.

[0045] With reference to Figure 11, the further solution for the infusion head 54 tends to achieve a substantially low profile shape of the head. For example, in some embodiments, the total height "s" may be between about 0.300 inches to about 0.400 inches. In a further preferred embodiment, the total height "s" of the infusion head is about 0.335 inches.

[0046] For a further advantageous solution, the infusion head 54 includes a passage for receiving a conduit 160. The conduit passage 160 is typically configured to facilitate attachment of the flexible end of the tube / conduit 162 to an interior clearance 164 as shown in Figure 11.

The duct receiving duct 160 may include any desired suitable cross section (e.g., as seen in the axial direction), but usually has a cross-section corresponding to the cross-section of the selected duct / tube 162.

[0047] The conductor / tube 162 typically has a round cross section with a diameter ranging from about 0.030 inch to about 0.10 inch. The tube / tube can be made of any material suitable for use for the transmission of fluids in medical applications. Typically, the tube will be made of polyethylene or polyvinyl chloride with a medical grade, although other materials may also be used. The end of the tube 162 that is on the opposite side of the infusion head may have a connector to connect the tube to the fluid transfer system with the exit from the pump or other fluid source. For example, in one embodiment, the end of the tube 162 on the opposite side of the infusion head has a "Luer lock" connector. Other connectors may alternatively be used, in accordance with the experience of the technicians, but in accordance with the disclosure of the present invention. [0048] Tube 162 can be attached to the infusion head 54 using any acceptable method or process as required. For example, in the disclosed embodiment, the channel for receiving the conduit 160 has a tapered diameter from its outer end 166 to the inner end 168. This constriction assures a tight fit, allowing the tube to be held in place due to the frictional force between the inner channel wall to receive the conduit 160 and the outer wall of the tube 162. If desired, the tube 162 can be additionally secured in the passage for receiving the conduit by the use of adhesives, ultrasonic welding, thermal welding, or any other available method.

[0049] As disclosed in Figs. 11, 13 and 14, the infusion head 54 may further comprise a hard cannula 170 with a channel 172 configured to provide fluid communication with the tube 162. The hard cannula 170 may be molded into a single molding at the same time. with the infusion head 54, or may be sequentially connected by any suitable process. The inner diameter of the canula of the hard cannula 172 is usually chosen so as to allow sufficient fluid to flow through its cross-section. For example, in some embodiments, the duct 172 has an internal diameter in the range between 0.01 inches to about 0.03 inches, and for another solution the duct 172 has an internal diameter of about 0.02 inches. Other diameter dimensions that go beyond the given ranges can also be used as required.

[0050] In the embodiment of Figure 9, the hard cannula 170 is embraced by the cylindrical wall 86 to protect the cannula 170 from contact with the user's fingers or other objects that can contaminate the sterility of the channel. The rigid cannula 170 can be placed within the cylindrical wall 86 in a manner that makes the cannula exactly aligned with the cylindrical wall 86, thus providing an automatic accurate centering of the cannula with respect to the center of the baffle 130 after connecting the cylindrical wall 86 to the port / port 62. As has already been explained above for the guide rod 64, the cylindrical wall 86 of the infusion head 54 preferably has a shape and size that substantially assures its tight fitting with the port / connection 62 of the base element 60. Providing a tight fit supports the alignment of the cannula 170 and the port / port. The tight fit also advantageously causes any forces applied to the infusion head 54, such that would cause the head to impact or pull the tube 162, to be applied to the intersection of the port and port part of the adjacent port 74 rather than to the latch legs (which could cause disconnecting the infusion head from the base element 60).

The hard cannula 170 is typically formed to extend through at least a portion of the baffle 130 when the infusion head and base member are joined together. In this way, the hard cannula 170 is usually dimensioned such that it extends beyond the connection part of the port 74 to a sufficient distance, i.e. when the wall of the port part of the port touches the upper surface 92 of the base element 60, then the rigid cannula 170 will protrude at least beyond the part of the baffle 130. Thus, the dimension "e" between the end 174 of the hard cannula 170 and the lower edge 182 of the port connector portion 74 is advantageously smaller than the dimension "j" between the upper surface 92 of the base element and the bottom point of the cavity 132 in port / port 64 (see Figure 5). In an alternative solution,

[0052] The hard cannula 170 also advantageously has sufficient vertical strength to allow it to be inserted through the baffle 130 (or other type of seal). Thus, the rigid cannula 170 is typically made of a rigid material such as PVC, PET, nylon, stainless steel, or other material suitable for use in medical applications and having sufficient stiffness.

[0053] In a similar way to that of the slide 64, the infusion head 54 preferably includes releasing catches 100 that can be compressed to release the cap from being connected to the base element 60. In the embodiment of the invention illustrated in FIG. 10, the releasing catches 100 are shown as half-round serrated and convex members positioned at an angle of about 90 ° to wings 98 and latch legs 94. The releasing lugs 100 may be gripped by fingers of the user to disengage the head 54 or 64 from the condition connected to the base element 60. By squeezing the releasing catches 100 the circular shape of the head 64 deforms to an elliptical shape, where the latch legs 94 are located on the long axis of the ellipse. In this way, compression of the head 64 at the points of the releasing latches 100 causes,

[0054] Methods of use and solutions of the infusion set described above will now be discussed with reference to Figs. 1-11. During preparation for inserting the infusion set into a patient, the base assembly 20 and the slider assembly 30 will typically be mounted as disclosed in figures 6 and 7. In some embodiments of the invention, the base assembly 20 and the slider assembly 30 may be provided to the target user in pre-form. already assembled. Alternatively, in other embodiments, the parts may be provided separately for assembly by the target user himself. [0055] According to a further embodiment of the invention, the patient may perform the following operations to place the soft cannula 52 and connect the infusion set. The patient can remove the needle shield 140 from the position shown in Fig.

[0056] The protective layer 150 can then be removed from the adhesive layer 50, thus exposing the "sticky" side of the adhesive layer to its attachment to the skin of the patient. When grasping the guide head 64 in any way, or using any tool, the guide needle 66 and the soft cannula 52 are pressed firmly towards the body and inserted through the patient's skin into the subcutaneous tissue of the patient until the adhesive layer 50 contacts the patient's skin. and stick to it. Adhesive layer 50 is best when it is free from corrugations or blisters, and then forms a well-fitting and secure connection.

[0057] After inserting the needle 66 and the soft cannula 52 at the required depth, the guide head 64 can be moved away from the base element 60 and from the patient. To disengage the guide head 64 from the base element 60, releasing catches 100 can be used. The fingers are grasped with fingers and compressed, causing the round head to deform and making the latch legs 94 disengage from the rim 96 of the base element 60. In an alternative embodiment the releasing lugs 100 can be interchanged alternately by a suitable tool. In further alternative solutions, the guide head 64 can be configured in a manner that releases the hooks by using a different type of manipulation (e.g., unscrewing, disassembling, etc.) to separate the guide head 64 from the base element 60. Further, in further embodiments,

[0058] Since the guide head 64 has been disconnected from the base element 60, the head is pulled away from the patient, and the needle 66 is withdrawn from the soft cannula 52. The soft cannula stays inside the patient, penetrating the required depth into the subcutaneous tissue and staying in place due to the device As already explained, the baffle 130 is typically configured to seal the fluid flow after removal of the needle 66, and thus prevent uncontrolled flow of fluids or contaminants through the cannula 52.

[0059] Since the base element 60 and the cannula 52 are already in place, the infusion head 54 can be connected to the base element 60, which happens by arranging the conduit tube 164 channel / infusion tube 162 into a position for fluid flow and connection to the cannula 52 After the user has connected the infusion head 54 to the base element 60, the port / port connecting portion 74 includes the port 62, thereby providing a hard axis position of the cannula 170 of the infusion head 54 with the slot 134 in the bulkhead 130. As previously discussed, the gap may be pre-formed by a needle 66 projecting from the baffle 130. The automatic axial junction of the hard cannula with the slot in the baffle 134 allows easy connection and reduces the risk of misalignment.This is especially beneficial for diabetics who often have problems with vision disorders.

[0060] The infusion head can now be pressed against the base element until the pawl legs engage with engagement with the rim 96 on the base member. For one embodiment of the invention, the infusion head 54 can be profiled in such a way as to produce an audible snap sound when the connection to the base element 60 is reached so as to allow the user to hear audible confirmation of the correct attachment of the infusion head to the base element.

[0061] There are many circumstances, such as a patient's bath, sleep, engaging in physical activities, etc., when it becomes important to disconnect the infusion set without removing the cannula from the patient's body. When the infusion set is disconnected, the base element is exposed to potential contamination by dust, dirt, bacteria and other contaminants. In addition, it is possible to attach or pull out the base element through clothing or other objects that present similar hazards. In such cases, for experienced practitioners, the solution of the present invention as well as the benefits of using the infusion set disclosed and described herein will be understood.

[0062] The infusion set disclosed in the present invention provides the possibility of repeatedly disconnecting and connecting the infusion head 54 and base element 60 to each other. Infusion head 54 can be detached from base element 60 by applying and applying force to release catches 100 so as to detach the ratchet legs 94, as is the case for the guide head 64, the infusion head 54 can be connected by applying pressure to the user's fingers or other appropriate tools or devices that cause the head to disengage from the base element 60.

[0063] The solutions used for the infusion set given herein provide for a single fluid path through the base element by extending the passage of this path through the hard cannula 170 of the infusion head 54 and the needle 66 of the adapter cap 64. Such configuration preferably reduces the number of possible contaminants inside infusion system. After disconnecting the infusion head 54, the septum 130 seals the liquid flow path, thereby securing the system against unintentional blood leakage, and secures the patient against uncontrolled particles and doses of fluid from the cannula 52.

[0064] As explained above, the base element 60 and the cannula 52 can remain in place on the patient's body for several days or longer, and in some circumstances, the base element can be disconnected from the infusion head for a few hours or more. The illustrated base element 60 preferably has a low profile, thereby reducing the probability that the base element 60 will be torn out by clothing, towels or other objects while the patient is bathing or dressing, etc. The dome shaped infusion head according to the invention, preferably covers the entire contour of the base element, thereby providing protection to the base element against contamination from dust, dirt, microorganisms or other contaminants. The low profile of the base member 60 and the substantially flat top surface of the baffle 130 are also advantageously substantially free of depressions or gaps that could accumulate contaminants. In addition, the low profile design reduces the likelihood that a patient accidentally strikes or knocks the infusion set during use, creating discomfort and / or causing a reordering or replacement of the infusion set.

[0065] In addition, the positioning of the baffle 130 at a location remote from the surface of the base element with respect to the patient's body advantageously makes it possible to carry out a simplified cleaning of the baffle. As explained and illustrated above, the baffle 130 is preferably positioned to rinse the ends of the port edge / port 62 to clean the flaps. This makes it easy to clean the baffle 130 and the port / baffle 62 by wiping with cotton and alcohol or another product cleaner suitable for use in medical applications.

[0066] In certain circumstances, it becomes desirable that the infusion set has sufficient freedom of manipulation during its installation and joining. For example, after assembly of the kit, the solution of the invention disclosed in Figure 12 has the advantage that the infusion head 54 can rotate relative to the base member about an axis perpendicular to the base plane 118 of the base member and passing through the center of the port / port 62. preferably allows the patient to rotate the tube / conduit 162 forward or backward relative to the patient's body without the need to apply a torque to the base element 60. In this way, the infusion set having the infusion head is able to rotate around the center axis of the base element while maintaining the fluid path connection between the pump and the patient's body,

[0067] The end of the tube 162 that is opposite the infusion head may be connected to a suitable fluid or other fluid source or before or after the infusion head 54 is mounted with the base element 60. In an alternative embodiment, the infusion pump may include additional tubing / tubes , connectors, or other elements between the soft cannula and fluid source.

[0068] In alternative embodiments of the invention, the base element 60 discussed and disclosed herein may be used to deliver therapeutic agents or other therapeutic fluids to the patient's body without the need for using the other components of the infusion set already discussed. For example, a base element such as the one described above can be used in conjunction with a standard subcutaneous syringe to deliver a therapeutic fluid to a patient by pulling the syringe cannula through the septum and injecting fluid through the soft cannula of the base member to the patient.

[0069] Although only certain solutions and examples have been described above, many aspects of the disclosed methods as well as the items of equipment described and explained in the present description can be variously configured and / or modified to form further applications for experienced medical practitioners. For example, each of the individual elements of the infusion set described and shown above may be used alone or in combination with other elements. In addition, it may also be recognized that the methods disclosed in the invention may be used in other sequences, and / or using other tools, if desired. Such alternative solutions and / or the use of methods and equipment described above and their obvious modifications as well as substitutes are considered to be within the scope of the present invention. In this way, the intention is fulfilled that the scope of the invention presented herein should not be limited only to individual solutions presented in the present description, but should be determined by reliable reading of the patent claims set forth in the description.