WO2020079056A1

WO2020079056A1 - Connector assembly for connecting medical lines

Info

Publication number: WO2020079056A1
Application number: PCT/EP2019/078049
Authority: WO
Inventors: Steffen BAUMGART
Original assignee: Fresenius Kabi Deutschland Gmbh
Priority date: 2018-10-19
Filing date: 2019-10-16
Publication date: 2020-04-23
Also published as: CN112867530A; EP3866905A1

Abstract

A connector assembly for connecting medical lines (3, 4) to each other comprises a first connector (1) having an insertion shaft (12), and a second connector (2) having an insertion opening (213), the insertion being insertable, along an insertion direction (I), into the insertion opening (213) for forming a fluid connection between the first connector (1) and the second connector (2), wherein the insertion shaft (12) of the first connector (1) comprises a first fluid channel (120) and the second connector (2) comprises a second fluid channel (212) extending from the insertion opening (213) for allowing fluid to flow in between the first connector (1) and the second connector (2). The second connector (2) comprises an outer part (20) and an inner part (21) received within the outer part (20), wherein the inner part (21) is rotatable with respect to the outer part (20) about a longitudinal axis (L) and forms the second fluid channel (212).

Description

Connector assembly for connecting medical lines

Description

The invention relates to a connector assembly for connecting medical lines to each other according to the preamble of claim 1.

A connector assembly of this kind comprises a first connector having an insertion shaft, and a second connector having an insertion opening, the insertion being insertable, along an insertion direction, into the insertion opening for forming a fluid connection between the first connector and the second connector. The insertion shaft of the first connector comprises a first fluid channel and the second connector comprises a second fluid channel extending from the insertion opening for allowing fluid to flow in between the first connector and the second connector.

A medical line of this kind may for example be a line used for the enteral feeding of a patient. Enteral feeding generally refers to the delivery of a nutritionally complete feed, containing protein, carbohydrate, fat, water, minerals and vitamins, directly into the stomach, duodenum or jejunum of a patient. A feeding tube, for this purpose, may for example be passed through the nares (nostril), down the esophagus and into the stomach (so-called nasogastric feeding tube). A nasojejunal feeding tube, in comparison, may be passed further through the stomach into the jejunum, the middle section of the small intestine. And a gastric feeding tube is a tube inserted through a small incision in the abdomen into the stomach and is used, preferably, for long-term enteral nutrition. When using feeding lines for the enteral feeding of a patient, a first line may for example be placed on the patient, for example providing a feeding port to the stomach. This first line may remain on the patient for a rather long time, for example a few days or even a few weeks. Another, second line may be connected to this first line for the actual feeding, wherein for each feeding procedure a new second line may be used and disposed after the feeding procedure.

A connector assembly in this example serves to connect the feeding lines to each other. A first connector (also denoted as male connector, for example a so-called ENFit male connector) herein may be arranged for example on the line placed on the patient, whereas a second connector (female connector, for example a so-called ENFit female connector) may be used on the second line for connecting the second line to the first line for carrying out an actual feeding procedure.

Such connectors may for example be connected to each other by means of a screw- type connection, the first connector comprising a first screw thread and the second connector comprising a second screw thread. For connecting the first connector and the second connector to each other, hence, a rotating movement of one connector with respect to the other is required.

In order to avoid having to rotate a tube connected to a connector together with the connector when connecting the connector to another connector, it has been proposed e.g. in WO 2018/086687 A1 to provide a screw cap on a male connector of a connector assembly, the screw cap being rotatable with respect to a tube section of the connector for establishing a screw connection to another connector. The screw cap comprises a screw thread on an inner circumferential face, which can be brought into engagement with a corresponding outer screw thread on an associated, other connector.

Within such connector assemblies it is desirable to provide for the possibility for an easy establishing of the connection as well as for an easy and comfortable disconnection of connectors from each other.

It is an object of the instant invention to provide a connector assembly which allows for an easy handling of the connectors, in particular for establishing a connection as well as for releasing a connection. This object is achieved by means of a connector assembly comprising the features of claim 1.

Accordingly, the second connector comprises an outer part and an inner part received within the outer part, wherein the inner part is rotatable with respect to the outer part about a longitudinal axis and forms the second fluid channel.

The connector assembly comprises a first connector and a second connector, the first connector having an insertion shaft and hence forming a male-type connector, and the second connector having an insertion opening for receiving the insertion shaft and hence forming a female-type connector. For connecting the first connector and the second connector to each other, the insertion shaft of the first connector is inserted into the complementary insertion opening of the second connector, such that a fluid channel extending through the insertion shaft of the first connector is brought into fluid connection with a corresponding fluid channel formed in the second connector and hence a fluid connection in between the first connector and the second connector is established.

The second connector herein comprises two parts, an outer part in particular allowing for a handling of the second connector in particular for establishing or releasing a connection in between the first connector and the second connector, and an inner part rotatable with respect to the outer part and forming the fluid channel of the second connector. The inner part may in particular be configured to receive a medical line associated with the second connector, in particular a medical tubing, such that the outer part can be rotated with respect to the inner part and a medical tubing connected to the inner part when establishing a connection in between the first connector and the second connector as well as when releasing a connection.

Because the handling of the second connector can take place by a user acting onto the outer part, which is functionally decoupled from the inner part connected for example to a medical tubing, an easy handling of the second, female-type connector for establishing a connection in between the first connector and the second connector as well as for releasing a connection in between the first connector and the second connector becomes possible.

The inner part is rotatable with respect to the outer part about a longitudinal axis. The fluid channel of the second connector herein may extend through the inner part along the longitudinal axis, the longitudinal axis being aligned with the insertion direction when placing the first connector and the second connector on each other.

The insertion opening herein may be formed at a first end of the fluid channel within the inner part, the insertion opening having a cylindrical or conical shape adapted to a corresponding shape of the insertion shaft of the first connector to be inserted into the insertion opening formed within the inner part of the second connector.

The insertion shaft likewise may for example have a cylindrical or conical shape. The fluid channel of the first connector herein extends through the insertion shaft along the insertion direction such that via the fluid channel a fluid connection in between the first connector and the second connector may be established when the second connector is connected to the first connector.

The first connector, in one embodiment, comprises a body circumferentially extending about the insertion shaft such that an inner space is formed radially in between the body and the insertion shaft. The body hence is placed at a radial distance to the insertion shaft and is arranged for example coaxially with the insertion shaft.

The connectors may for example be connected to each other by means of a screw connection. Herein, for example on an inner face of the body of the first connector a first screw thread may be provided, the first screw thread being engageable with a second screw thread formed on the outer part of the second connector, for example on a circumferential outer wall of the outer part. Hence, for connecting the connectors to each other, the connectors are screwed together, such that the insertion shaft of the first connector is inserted along the insertion direction in the corresponding insertion opening of the second connector.

The connector assembly provides for the connection between lines, for example feeding lines for the enteral feeding. Correspondingly, the first connector may comprise a connection shaft axially aligned with the insertion shaft for receiving a first connection line, whereas the second connector may comprise, on the inner part, a tube fitting section axially aligned with the fluid channel and the insertion opening formed within the inner part, the tube fitting section being designed for receiving a second connection line, in particular a medical tubing. The tube fitting section herein may be formed at a second end of the fluid channel opposite the first end of the fluid channel at which the insertion opening is formed, such that a second line may be connected to the second connector at a location opposite to the insertion opening. Hence, connection lines, such as feeding lines in the shape of medical tubings, may be connected to the connectors and, via the connectors, may be connected to each other to provide for a liquid transfer between the connection lines.

In one embodiment, the outer part of the second connector comprises a body portion and at least one grip element formed on the body portion in order to allow a user to handle the second connector. The grip element may in particular be formed in the shape of a wing radially protruding from the body portion of the outer part and allowing a user to grip the outer part in order to establish or to release a connection in between the first connector and the second connector.

By acting onto the outer part via the at least one grip element a user in particular may rotate the outer part of the second connector with respect to the first connector in order to establish a screw connection in between the connectors. The inner part of the second connector herein may remain rotationally stationary with respect to the first connector, such that a medical line connected to the inner part of the second connector is not rotated when establishing or releasing a connection in between the first connector and the second connector.

In one embodiment, the inner part of the second connector is received within a bearing opening of the outer part and is rotatable within the bearing opening. The inner part and the outer part herein, in one embodiment, are axially fixed with respect to each other by a positive locking connection, for example by means of a fixation element formed on one of the inner part and the outer part engaging with a corresponding retention groove formed on the other of the inner part and the outer part. The positive locking connection herein is such that the inner part and the outer part are axially held in place with respect to each other, the inner part however being rotatable with respect to the outer part.

Because the inner part and the outer part are rotatable with respect to each other, but at the same time are axially fixed with respect to each other, in particular an easy disconnection of the first connector and the second connector from each other becomes possible, because for releasing a screw-type connection the outer part of the second connector may be unscrewed from the first connector, thus axially displacing the outer part with respect to the first connector along the longitudinal axis and carrying the inner part axially along, such that the inner part is easily released from the first connector. In one embodiment, the second connector is formed using an injection molding technique. Herein, the outer part and the inner part may be fabricated by the same material, in particular a plastics material, or by different materials, in particular different plastics materials. If the inner part and the outer part are formed by different materials, for example a two-component injection molding technique may be used for fabricating the second connector, within the two-component injection molding technique the inner part and the outer part being formed in a common molding tool as separate, but rotatably interconnected parts.

The idea underlying the invention shall subsequently be explained in more detail with reference to the embodiments shown in the figures. Herein:

Fig. 1 shows a schematic drawing of a feeding line placed on a patient;

Fig. 2 shows an embodiment of a connector assembly having a first connector and a second connector;

Fig. 3A shows a view of an embodiment of a second connector of a connector assembly;

Fig. 3B shows a different perspective view of the second connector; and

Fig. 4 shows a sectional view of the second connector element.

Fig. 1 shows a schematic drawing of a feeding line assembly comprising feeding lines 3, 4 placed on a patient P.

The feeding lines 3, 4 for example serve for providing for an enteral feeding of the patient P. For this, a first line 3 may, for example through an incision in the abdomen of the patient P, be inserted into the stomach of the patient P and may be used as a port for a long-term enteral feeding. A second feeding line 4 is connected to the first feeding line 3 via a connector assembly comprising connectors 3, 4, the second feeding line 4 for example being connected to a container comprising an enteral feeding solution, which via the lines 3, 4 is delivered towards the patient P for example using a suitable pumping device. Whereas the second feeding line 4 may be used for example only once in connection with the container comprising the enteral feeding solution and may be disposed after use, the feeding line 3 placed on the patient P may remain on the patient P for a rather long term, for example a few days or even a few weeks, and may be used multiple times to carry out multiple feeding procedures.

An embodiment of a connector assembly comprising connectors 1 , 2 is shown in Fig. 2. The first connector 1 herein may for example be connected to the feeding line 3 placed on the patient P, whereas the second connector 2 is arranged on the other, second feeding line 4 connected to a container comprising a feeding solution.

The first connector 1 , in this embodiment, comprises a cylindrical body 10 circumferentially and coaxially extending about a cylindrical or conical insertion shaft 12 and forming, together with the insertion shaft 12, a radial inner space 13. On the inner wall of the body 10 a screw thread 100 is arranged allowing for a screw-type connection with the second connector 2.

The insertion shaft 12 can be inserted in an insertion direction I into an insertion opening 213 of the second connector 2. The second connector 2 comprises a screw thread 200 formed on a circumferential outer wall of a shaft portion 201 , such that the second connector 2 can be screwed into the inner space 13 of the first connector 1 by engaging the screw threads 100, 200 with each other and by screwing the first connector 1 along a screwing direction S on the second connector 2.

The insertion shaft 12 has a substantially cylindrical or conical shape having a circular cross section. The insertion opening 213 of the second connector 2 has a corresponding, complementary shape and hence is suited to receive the insertion shaft 12.

When screwing the connectors 1 , 2 onto each other, the insertion shaft 12 is inserted into the insertion opening 213. The insertion shaft 12 comprises a fluid channel 120, which extends through the insertion shaft 12 and through a shaft 1 1 aligned with the insertion shaft 12, the shaft 1 1 being connected to the associated feeding line 3. Likewise, a feeding line 4 is connected to the second connector 2. Hence, by connecting the connectors 1 , 2 to each other, a fluid connection between the feeding lines 3, 4 can be established, such that a medical fluid such as an enteral feeding solution may pass from the feeding line 4 through the connectors 1 , 2 into the feeding line 3. Figs. 3A, 3B and 4 show an embodiment of the second connector 2, the second connector 2 comprising an outer part 20 and an inner part 21 rotatably received within the outer part 20. The outer part 20 forms the shaft portion 201 (carrying the screw thread 200 on its circumferential outer wall) and the body portion 202, a bearing opening 204 being formed within the shaft portion 201 and the body portion 202 for receiving the inner part 21 within.

The inner part 21 is rotatable with respect to the outer part 20 about a longitudinal axis L. Within the inner part 21 , herein, the insertion opening 213 for receiving the insertion shaft 12 of the first connector 1 is formed, the insertion opening 213 forming part of a fluid channel 212 extending along the longitudinal axis L through the inner part 21 of the second connector 2.

As visible from Fig. 4, the insertion opening 213 is formed at a first end 210 of the fluid channel 212 and may have for example a cylindrical or conical shape, corresponding to the shape of the insertion shaft 12 of the first connector 1 such that the insertion shaft 12 may be tightly received within the insertion opening 213. At a second end 21 1 of the fluid channel 212 opposite the first end 210 a tube fitting section 214 is formed within the inner part 21 , the tube fitting section 214 being configured to receive an associated medical line 4, for example a medical feeding line in the shape of a medical tubing, wherein the medical line 4 may for example be glued to the inner part 21 for establishing a fixed connection. The tube fitting section 214 is in fluid connection with the insertion opening 213 by a pathway 215, the insertion opening 213, the tube fitting section 214 and the pathway 215 hence together forming the fluid channel 212 axially extending within the inner part 21.

The outer part 20 forms a housing for the inner part 21 by receiving the inner part 21 within the bearing opening 204. The inner part 21 herein is rotatable about the longitudinal axis L with respect to the outer part 20, but is axially fixed with respect to the outer part 20 by means of a fixation element 216 in the shape of a circumferential protrusion formed on the inner part 21 engaging with a complementary, circumferential retention groove 205 formed within the bearing opening 204 of the outer part 20, as visible from Fig. 4.

The inner part 21 and the outer part 20 hence are axially fixed with respect to each other, but can be rotated independently of each other about the longitudinal axis L. For establishing the connection between the first connector 1 and the second connector 2, the first connector 1 and the second connector 2 may be placed on each other and may be screw-connected to each other by screwing the outer part 20 of the second connector 2 into the space 13 confined by the body 10 of the first connector 1. The screw thread 200 of the second connector 2 hence is screw-connected to the corresponding, complementary screw thread 100 of the first connector 1 , such that a screw connection between the first connector 1 and the second connector 2 is established.

By screw connecting the first connector 1 and the second connector 2 to each other, the insertion shaft 12 of the first connector 1 is brought into engagement with the insertion opening 213 formed within the inner part 21 of the second connector 2, such that a fluid connection in between the first connector 1 and the second connector 2 is established.

The second connector 2, on the body portion 202 of the outer part 20, comprises grip elements 203 in the shape of radially protruding wings, the grip elements 203 allowing a user to grab the outer part 20 for handling the second connector 2, in particular for screwing the outer part 20 into the space 13 formed on the first connector 1 and for unscrewing the outer part 20 from the first connector 1. During the establishment and also during the release of the screw connection in between the first connector 1 and the second connector 2, the outer part 20 is rotated with respect to the first connector 1 , wherein the inner part 21 however may remain rotationally stationary with respect to the first connector 1 , such that a medical line 4 connected to the inner part 21 also remains stationary when establishing or releasing the connection.

When disconnecting the second connector 2 from the first connector 1 , the outer part 20 is unscrewed from the body 10 of the first connector 1 , hence releasing the screw connection and at the same time axially displacing the outer part 20 along the insertion direction I with respect to the first connector 1. The inner part 21 herein axially is carried along with the outer part 20, such that the insertion shaft 12 is released from the insertion opening 213 formed within the inner part 21 synchronously with releasing the screw connection in between the first connector 1 and the second connector 2. The releasing of the connection hence is easy and comfortable for a user, a user in particular not having to take any additional action in order to release a potentially tight connection in between the insertion shaft 12 of the first connector 1 and the insertion opening 213 formed within the inner part 21 of the second connector 2. The connectors 1 , 2 each may for example be fabricated from a comparatively hard plastics material, for example by injection molding. The second connector 2 herein may be for example formed by a two-component injection molding technique, wherein the inner part 21 and the outer part 20 may be formed by similar materials or by different materials.

The invention is not limited to the embodiments described above, but may be implemented in an entirely different fashion.

For example, a connector assembly of the kind described herein may not only be used for the enteral feeding, but may be used for connecting any medical lines to each other for transferring medical solutions, such as medication, nutritional solutions, saline solutions or any other solutions.

A connector of the a connector assembly as described herein may in particular use a LuerLock or ENFit connector design for its connector element.

List of Reference Numerals

1 Connector (male part)

10 Body

100 Screw thread

101 Protrusion

1 1 Shaft

12 Insertion shaft

120 Fluid channel

121 Surface (outer wall)

122 Tip

13 Space

2 Connector (female part)

20 Outer Part

200 Screw thread

201 Shaft portion

202 Body portion

203 Grip element

204 Bearing opening

205 Retention groove 21 Inner part

210 First end

21 1 Second end

212 Fluid Channel

213 Insertion opening

214 Tube fitting section

215 Pathway

216 Fixation element

3 Line

4 Line

I Insertion direction

L Longitudinal axis

P Patient

5 Screwing direction

Claims

Claims:

1. Connector assembly for connecting medical lines (3, 4) to each other, comprising:

a first connector (1 ) having an insertion shaft (12), and

a second connector (2) having an insertion opening (213), the insertion being insertable, along an insertion direction (I), into the insertion opening (213) for forming a fluid connection between the first connector (1 ) and the second connector (2),

wherein the insertion shaft (12) of the first connector (1 ) comprises a first fluid channel (120) and the second connector (2) comprises a second fluid channel (212) extending from the insertion opening (213) for allowing fluid to flow in between the first connector (1 ) and the second connector (2), characterized in that the second connector (2) comprises an outer part (20) and an inner part (21 ) received within the outer part (20), wherein the inner part (21 ) is rotatable with respect to the outer part (20) about a longitudinal axis (L) and forms the second fluid channel (212).

2. Connector assembly according to claim 1 , characterized in that the second fluid channel (212) extends through the inner part (21 ) along the longitudinal axis (L).

3. Connector assembly according to claim 1 or 2, characterized in that the insertion opening (213) is formed at a first end (210) of the second fluid channel (212) within the inner part (21 ), the insertion opening (213) having a cylindrical or conical shape.

4. Connector assembly according to one of claims 1 to 3, characterized in that the insertion shaft (12) has a cylindrical or conical shape, the fluid channel (120) extending along the insertion direction (I) in the insertion shaft (12).

5. Connector assembly according to one of the preceding claims, characterized in that the first connector (1 ) comprises a body (10) circumferentially extending about the insertion shaft (12) such that an inner space (13) is formed radially in between the body (10) and the insertion shaft (12).

6. Connector assembly according to one of claims 5, characterized in that the body (10) of the first connector (1 ) comprises a first screw thread (100) and the outer part (20) of the second connector (2) comprises a second screw thread (200), the first screw thread (100) and the second screw thread (200) being screw-connectable for connecting the first connector (1 ) and the second connector (2) to each other.

7. Connector assembly according to one of the preceding claims, characterized in that the first connector (1 ) comprises a connection shaft (1 1 ) axially aligned with the insertion shaft (12) for receiving a first connection line (3).

8. Connector assembly according to one of the preceding claims, characterized in that the inner part (21 ) comprises a tube fitting section (214) for receiving a second line (4).

9. Connector assembly according to one of the preceding claims, characterized in that the outer part (20) comprises a body portion (202) and at least one grip element (203) formed on the body portion (202) for handling the second connector (2).

10. Connector assembly according to one of the preceding claims, characterized in that the inner part (21 ) is received within a bearing opening (204) of the outer part (20) and is rotatable within the bearing opening (204).

1 1. Connector assembly according to one of the preceding claims, characterized in that the inner part (21 ) and the outer part (20) are axially fixed with respect to each other by a positive-locking connection.

12. Connector assembly according to one of the preceding claims, characterized in that the outer part (20) and the inner part (21 ) are fabricated by using an injection molding technique.