WO2010052698A1

WO2010052698A1 - A blood transfusion set

Info

Publication number: WO2010052698A1
Application number: PCT/IL2009/000820
Authority: WO
Inventors: Eran Dan Sethon; Tomer Iakobi
Original assignee: Eran Dan Sethon; Tomer Iakobi
Priority date: 2008-11-06
Filing date: 2009-08-25
Publication date: 2010-05-14
Also published as: IL195134A; IL195134A0

Abstract

In one aspect, the present invention is directed to a blood transfusion set, comprising: a blood bag, for accumulating blood from a donor's vein; an intravenous cannula, for enabling safe connection to the donor's vein; and a tubule, connecting the intravenous cannula to the blood bag, for allowing blood passage between the intravenous cannula and the blood bag. According to one embodiment of the invention, the intravenous cannula comprises: a flexible catheter; a trocar, for puncturing a donor's vein and for providing stiffness to the catheter while puncturing; a handle to which the trocar is connected, for enabling removal of the trocar from the catheter; and a flexible seal, for blocking blood spillage from the catheter upon removing the trucar. In a further embodiment of the invention, the tubule comprises a sterile connector for connecting and disconnecting blood bags to / from the cannula.

Description

A BLOOD TRANSFUSION SET

Field of the Invention

The present invention relates to the field of blood transfusion sets.

Background of the Invention

Presently, the basic components of blood transfusion sets comprise the following:

- a hard trocar (a sharp pointed needle) for entry into a vein;

- a blood bag, which is a receptacle for storing the transfused blood; and - a tubule connecting the trocar to the blood bag.

One of the drawbacks of the prior art transfusion sets is that the hard trocar thereof remains in the donor's veins throughout the process of blood transfusion, thereby exposing the blood donor to discomfort, possible hemorrhage at the puncture, physical damage, and so on. In addition, in the event the trocar misses the vein during puncturing, the entire blood transfusion set must be disposed of, as it loses sterility. The same applies also for infusion.

It is an object of the present invention to provide a solution to the above-mentioned and other problems of the prior art.

Other objects and advantages of the invention will become apparent as the description proceeds. Summary of the Invention

The following embodiments and aspects thereof are described and illustrated in conjunction with systems, tools methods, and so forth, which are meant to be merely illustrative, not limiting in scope.

In one aspect, the present invention is directed to a blood transfusion set (100), comprising:

- a blood bag (2), for accumulating blood transfused from a donor's vein;

- an intravenous cannula (12), for enabling safe connection to the donor's vein; and

- a tubule (14), connecting the intravenous cannula to the blood bag, for allowing blood passage between the intravenous cannula and blood bag.

According to one embodiment of the invention, the intravenous cannula comprises:

- a flexible catheter (20); - a trocar (22), for puncturing a donor's vein and for providing stiffness to the catheter during the puncturing procedure;

- a handle (24) connected to the trocar, for enabling removal of the trocar from the catheter; and

- a flexible seal (32), for blocking blood spillage from the catheter upon removing the trocar.

The tubule (14) may be divided into two parts connected by a connector, thereby allowing disposing the intravenous cannula without disposing the entire blood transfusion set. According to one embodiment of the invention, the connector provides a sterile connection.

According to one embodiment of the invention, the connector comprises:

- a male member (4) having a flexible seal (40);

- a female member (6), having a flexible seal (34);

- a hollowed needle (42);

- wherein connecting the male member to the female member causes penetration of the needle through the flexible seals, thereby generating a sterile passageway between the male member and the female member.

The connector may further comprise a receptacle storing sterilizing substance, and being deployed in the way of the needle from one member of the connector to the other.

According to one embodiment of the invention, the blood bag (2) comprises: - a first tubule (8), connectable to the tubule of the intravenous cannula; and

- a second tubule (10), connectable to another blood bag; thereby allowing employing an arbitrary number of blood bags in the blood transfusion set.

The connection mechanism between the male and female member can be a threaded connection, a conic connection, and so on. The blood transfusion set may further comprise a port, through which a fluid can be injected to the user thereof, wherein said port comprising a flexible seal.

As mentioned above, one of the drawbacks of the prior art transfusion sets is that the hard trocar thereof remains in the donor's veins throughout the process of blood transfusion, thereby exposing the blood donor to discomfort, possible hemorrhage at the puncture, physical damage, and so on. The present invention overcomes this obstacle by using a cannula instead of the trocar used in the prior art.

The present invention also provides a blood transfusion set that enables attaching and detaching blood bags and replacing the cannula, without losing its sterility. This is achieved by employing the sterile connectors (4 and 6). In comparison, in the prior art if the attempt to reach the vein fails, the entire blood bag must disposed as it loses its sterility. For example, a bag may be separated from the set in order to separate the blood components by centrifugation. Nevertheless, if sterile connectors (4 and 6) are employed, the sterility of the blood transfusion set is maintained.

It should be noted that although the present invention is directed to blood transfusion, the same set applies also for infusion.

In addition to the exemplary aspects and embodiments described above, further aspects and embodiments will become apparent by reference to the figures and by study of the following detailed description. Brief Description of the Drawings

The objects and features of the present invention will become apparent from the following detailed description considered in conjunction with the accompanying drawings, in which:

Fig. 1 schematically illustrates a blood transfusion set, according to one embodiment of the invention.

Each of Figs. 2, 3 and 4 schematically illustrates the structure of an intravenous cannula, according to one embodiment of the invention.

Fig. 5 is a sectional view that schematically illustrates a sterile connector, according to one embodiment of the invention.

Fig. 6 is a sectional view that schematically illustrates the way the male and female members of Fig. 5 are connected.

It is to be understood, however, that the drawings are designed solely for purposes of illustration and not as a definition of the limits of the invention, for which reference should be made to the appended claims. It should be further understood that the drawings are not necessarily drawn to scale and that, unless otherwise indicated, are merely intended to conceptually illustrate the structures and procedures described herein. Reference numerals may be repeated among the figures in order to indicate corresponding or analogous elements. Detailed Description of Preferred Embodiments

In the following detailed description, numerous specific details are set forth in order to provide a thorough understanding of the invention. However, it will be understood by those skilled in the art that the present invention may be practiced without these specific details. In some instances, well-known methods, procedures, components and circuits have not been described in detail, for the sake of brevity.

In order to facilitate the description herein, the following terms are explained:

An intravenous cannula is a flexible tube which when inserted into a body, is used to either withdraw fluid or inject medication. It normally comes with a trocar (a sharp pointed needle) attached which allows puncture of the body to get into the intended space. Abbocath™, Venflon™, Optiva™ and Peta™ are trademarks of intravenous cannulas.

A catheter is a tubule used to drain body fluids or to keep a passage open.

A trocar is a sharp pointed needle.

The way the present invention deals with the drawbacks of the prior art is by a blood transfusion set making use of an intravenous cannula in order to drive a catheter into a human (or animal) body. The intravenous cannula, which is marked herein by reference numeral 12, enables removal of its trocar (marked herein by reference numeral 22) from the vein once the catheter is placed into a vein, thereby removing the dangerous object, i.e., the trocar, from the donor's body.

Another novel feature of the present invention is the use of a replaceable intravenous cannula. Thus, in the event the puncturing process misses a vein, only the intravenous cannula is disposed of, and replaced with a new one. This is in contrast to the prior art in which the entire blood transfusion set had to be disposed.

An additional novel feature of the present invention is employing a desired number of blood bags, in contrast to one or two as in the prior art. This is achieved by connecting the blood bags in line. Thus, once one blood bag is filled, the blood enters into the next bag in line. This provides a visual indication about the current number of blood portions in the bags.

An additional novel feature of the present invention is employing a seal in the exit from the intravenous cannula. The seal (marked herein by numeral 32, and seen in Fig. 4) prevents blood from spilling out when the trocar is removed. This is in contrast to the prior art, in which removal of the trocar results in blood spillage, until the medician connects a tubule to the open cavity. As it is made of flexible material, once the needle is pulled out, the bore of the needle is blocked.

As a substitute to the cavity blocked by the flexible seal, the intravenous cannula comprises a tubule (marked herein by numeral 14) which is connectable to the first blood bag in line via sterile connectors (each connector comprises a male member 4 and a female member 6). Fig. 1 schematically illustrates a blood transfusion set, according to one embodiment of the invention.

A blood transfusion set according to embodiments of the present invention is marked herein by reference numeral 100.

The blood transfusion set 100 illustrated in Fig. 1 makes use of an intravenous cannula 12, as a substitute for prior art trocars. A tubule

14 connects the intravenous cannula to a blood bag 2 through a sterile connection, which is illustrated herein by male member 4 and female member 6 of the sterile connector thereof.

Blood bag 2 comprises two entries / exits: one connects the bag to intravenous cannula 12 via a tubule 8, and the other connects bag 2 to another blood bag 2a via a sterile connector at tubule 10, thereby allowing joining a desired number of blood bags in one blood transfusion set.

As intravenous cannula 12 connects to tubule 14 of bag 2 by a sterile connector, in case a medic misses a vein, only the intravenous cannula can be disposed of, in contrast to the prior art, wherein the entire blood transfusion set must be disposed of due to lack of sterile connectors.

Fig. 2 schematically illustrates the intravenous cannula 12 in the situation of being inserted into a human (or animal) vein. Fig. 3 schematically illustrates the intravenous cannula in a situation wherein its trocar 22 is pulled out from catheter 20. Fig. 4 is a sectioned exploded view detailing the interior structure of the intravenous cannula.

When trocar 22 is inserted into catheter 20, the tip 18 of the trocar outstands from the catheter. This allows using the trocar as means for puncturing a vein of a blood donor.

Once the trocar along with the catheter enters the donor's vein, the medic removes the trocar by pulling handle 24 (as illustrated in Fig. 3), leaving only the catheter, i.e., without the trocar, in the vein. As the catheter is made of flexible material, it does not endanger the donor's body.

Reference is made now to Fig. 4. One novel feature of the present invention is the use of a seal 32 to keep sealed cavity 26 of the intravenous cannula 12.

Seal 32 is made of flexible material, and as such, after punching the seal with a needle and removing the needle, the seal returns to its previous form. In other words, the seal functionality is not defected, i.e., the flexible seal still prevents passage of fluids and gasses therethrough. Thus, the flexible seal allows removing the trocar while keeping cavity 26 sealed, and nevertheless there is no blood spillage from cavity 26.

For comparison, in the prior art, the medic would need to

"quickly" connect a tubule to the exposed cavity of a blood transfusion set, in order to prevent blood spillage.

The solution presented herein, i.e., the use of a flexible seal in an intravenous cannula, increases the sterility of the blood transfusion set, and in addition, the blood donation process becomes less daunting for people sensitive to the sight of spilled blood.

As cavity 26 remains sealed, the blood is transferred to bag 2 through tubule 14. Tubule 14 is connected at one end thereof to the interior space of the intravenous cannula (i.e., into which the blood enters and fills), and at the other end thereof to a male member 4 of a sterile connector. The sterile connector allows connecting and disconnecting the cannula from the blood bag in a sterile manner. Thus, in the event a medic has failed to correctly-puncture the donor's vein and therefore must repeat this process, only the cannula has to be disposed of in order to maintain sterility, in contrast to the prior art wherein the entire blood transfusion set has to be disposed of, as being a unified structure.

It should be noted that prior art intravenous cannulae do not comprise a flexible seal 32 for the cavity of the catheter, nor a tubule 14.

The connector comprises a male member 4, in which the passage therein is blocked by a flexible seal 40; a female member 6, in which the passage therein is blocked by a flexible seal 34; and a hollowed needle 42, for generating upon connection, a sterile passageway between members 4 and 6 over their seals.

Numeral 36 denotes an aperture of female member 6, which is also used as connection means to a tubule (not illustrated). Numeral 44 denotes an aperture of male member 4, which is used also as connection means to a tubule (not illustrated).

Numeral 34 denotes a flexible seal of female connector 6. Being made of flexible material, once a needle is pulled out of seal 34, the bore created is blocked.

Numeral 40 denotes a flexible sealed cover that surrounds needle

42 of male member 4 in order to keep the needle environment sterile. The thickness of sealed cover 40 is "thin" in order to allow its deformation upon applying light force, but returns to its original form after the force ceases.

Fig. 6 is a sectional view that schematically illustrates the way the male and female members of Fig. 5 connect. It should be noted that the elements of Fig. 6 are drawn at a different scale than those of Fig. 5.

When male member 4 is pushed towards female member 6 to generate a connection between these parts, the applied force causes deformation of flexible sealed cover 40. As pressure on the members continues, needle 42 penetrates sealed cover 40 and thereafter through the flexible seal 34. Thus, the hollow within needle 42 connects aperture 36 of female member 6 with aperture 44 of male member 4, thereby allowing fluid passage therethrough. Assuming the space of apertures 36 and 44 is sterile, sterilization is maintained at connection of the apertures.

According to one embodiment of the invention, a receptacle made of flexible sealing material and filled with sterilizing substance is placed in the needle's lane, thereby upon connecting the male and female members of the connector, the needle is sterilized, as it must pass through the receptacle.

According to another embodiment of the invention, the space of cover 40 is filled with sterilizing substance, thereby fully maintaining sterilization of needle 42.

According to one embodiment of the invention, the connection mechanism between the male and the female member is based on corresponding threads. As such, this type of connection is referred herein as threaded connection.

According to another embodiment of the invention, the connection mechanism is based on deformation, i.e., one has to apply a force in order to deform the mating members. The deformation keeps the mating members attached. In order to enable to a user to apply less force, the form of the connecting parts is conic. As such, this type of connection mechanism is referred herein as conic connection.

In the illustrations herein, the connector is used for connecting tubule 14 of the intravenous cannula with blood bag 2, and for connecting one blood bag to another, but it should be noted that the sterile connector illustrated in Figs. 5 and 6 may be employed to connect any two tubules in a sterile manner.

Reference numeral 16 denotes a port of intravenous cannula 12, for injecting a substance into the blood circle of the donor, and so on. The presently design of the port makes use of a unidirectional valve. According to one embodiment of the invention, the port is designed as a female member of a connector (such as part 6), corresponding to a male member thereof (such as part 4).

Of course, these are merely examples, and those skilled in the art will appreciate that other sterile connectors may be employed, and still obtain the same result.

In the figures and/or description herein, the following reference numerals have been mentioned:

- numeral 100 denotes a blood transfusion set, according to one embodiment of the invention;

- numeral 2 denotes a blood bag;

- numeral 2a denotes an additional blood bag, connected in line to blood bag 2;

- numeral 4 denotes a male member of a sterile connector; - numeral 6 denotes a female member of a sterile connector;

- numeral 8 denotes a tubule connecting blood bag 2 to intravenous cannula 12;

- numeral 10 denotes a tubule for connecting blood bag 2 to blood bag 2a; - numeral 12 denotes an intravenous cannula;

- numeral 14 denotes a tubule which connects the interior space of intravenous cannula 12 to tubule 8 of blood bag 2;

- numeral 16 denotes a port of intravenous cannula 12, for taking samples during transfusion, injecting a substance, and so on; - numeral 18 denotes the tip of trocar 22 of intravenous cannula 12;

- numeral 20 denotes a flexible catheter which corresponds to trocar 22 of intravenous cannula 12;

- numeral 22 denotes a trocar of intravenous cannula 12;

- numeral 24 denotes a handle connected to trocar 22, to allow pulling the trocar out for catheter 20;

- numeral 26 denotes a cavity (opening) of intravenous cannula 12;

- numeral 28 denotes the "wings" of intravenous cannula 12;

- numeral 30 denotes an opening of female member 6 of a sterile connector; - numeral 32 denotes a flexible seal, for sealing cavity 26; - numeral 36 denotes an aperture of female member 6, which is used also as connection means to a tubule;

- numeral 38 denotes an opening of male member 4, the size of which corresponds to that of female member 6; - numeral 40 denotes a flexible sealed cover of needle 42;

- numeral 42 denotes a needle for generating a fluid passageway between the male and the female members of a sterile connector; and

- numeral 44 denotes an aperture of male member 4, which is also used as connection means to a tubule.

While certain features of the invention have been illustrated and described herein, the invention can be embodied in other forms, ways, modifications, substitutions, changes, equivalents, and so forth. The foregoing description of the embodiments of the invention has been presented for the purposes of illustration and description. It is not intended to be exhaustive or to limit the invention to the precise form disclosed. Many modifications and variations are possible in light of this disclosure. It is intended that the scope of the invention be limited not by this detailed description, but rather by the claims appended hereto.

Claims

1. A blood transfusion set, comprising: - a blood bag, for accumulating blood from a donor's vein;

- an intravenous cannula, for enabling safe connection to said donor's vein; and

- a tubule, connecting said intravenous cannula to said blood bag, for allowing blood passage between said intravenous cannula and said blood bag.

2. A blood transfusion set according to claim 1, wherein said intravenous cannula comprises:

- a flexible catheter; - a trocar, for puncturing a donor's vein and for providing stiffness to said catheter;

- a handle to which said trocar is connected, for pulling said trocar out of said catheter; and

- a flexible seal, for blocking blood spillage from said catheter upon removing said trocar.

3. A blood transfusion set according to claim 1, wherein said tubule is divided into two parts connected by a connector, thereby allowing disposing said intravenous cannula.

4. A blood transfusion set according to claim 3, wherein said connector provides a sterile connection.

5. A blood transfusion set according to claim 4, wherein said connector comprises: - a male member having a flexible seal;

- a female member, having a flexible seal;

- a hollowed needle;

- wherein connecting said male member to said female member causes penetration of said needle through the flexible seals, thereby generating a sterile passageway between said male member and said female member.

6. A blood transfusion set according to claim 5, further comprising a receptacle storing sterilizing substance, said receptacle being deployed in the way of said needle from one member to the other.

7. A blood transfusion set according to claim 5, wherein the connection mechanism of said male member to said female member is selected from a group comprising: threaded connection, and conic connection.

8. A blood transfusion set according to claim 1, wherein said blood bag comprises: - a first tubule, connectable to the tubule of said intravenous cannula; and

- a second tubule, connectable to another blood bag; thereby allowing employing a desired number of blood bags in said blood transfusion set.

9. A blood transfusion set according to claim 1, further comprising a port, through which a fluid can be injected to the user thereof, said port comprising a flexible seal.