WO2008074039A1

WO2008074039A1 - Infusion port with windable tube

Info

Publication number: WO2008074039A1
Application number: PCT/AT2007/000520
Authority: WO
Inventors: Walter Egle
Original assignee: Ami Agency For Medical Innovations Gmbh
Priority date: 2006-12-20
Filing date: 2007-11-19
Publication date: 2008-06-26
Also published as: DE202007018910U1; AT504511A4; AT504511B1

Abstract

A port catheter for the introduction of a liquid into a hollow organ of a human or animal body comprises a cup (1) which has an inner chamber (5) for the intake of the liquid supplied to the cup (1) and a tube (7) connected at one connecting end (8) to the cup (1). Said tube has an inner channel (11) which communicates with the chamber (5) of the cup (1) and through which the liquid can be guided into the hollow organ. The port catheter further comprises a mounting part (15) which can be attached to the human or animal body tissue, wherein the cup (1) can be rotated relative to the mounting part (15) in order to change the length of a section of the tube (7), which section adjoins the connecting end (8) and by means of which the tube (7) runs around at least one section of the circumference of the cup (1).

Description

INFUSION SPORT WITH WRAPPING TUBE

The invention relates to a port catheter for introducing a liquid into a hollow organ of a human or animal body comprising a pot which has an inner chamber for receiving the liquid supplied to the pot, and a hose connected to the pot at a connecting end and having an inner channel , which rather communicates with the chamber of the pot and through which the liquid can be conducted into the hollow organ.

Port catheters are used for introducing fluids into hollow organs of the human or animal body, for example for drug treatment. Thus, e.g. in chemotherapy drugs are introduced directly into the bloodstream. Apart from the introduction of fluids into blood vessels, port catheters can also be used to introduce fluids into the gastrointestinal tract, bladder and other hollow organs.

Port catheters usually have a pot with a chamber closed by a silicone membrane and a tube connected to the pot. The liquid to be introduced into the hollow organ is injected by piercing the silicone membrane into the chamber of the pot and passes through the inner channel of the tube, which is arranged with its discharge end in the hollow organ, into the hollow organ. Usually, the pot is implanted subcutaneously.

A conventional surgical method for implanting the port catheter is the Seldinger technique. In this case, a needle with a sleeve arranged thereon is inserted into the hollow organ, in particular the blood vessel. After pulling out the inner needle, the hose can be inserted with its delivery end ahead through the sleeve into the hollow organ until the delivery end has reached the desired location. As a result, the sleeve is removed. The sleeve is longitudinally separable along a tear line for this purpose and thus removable from the hose. As a result, the hose is cut to the desired length and attached to a connecting piece of the pot. The pot is inserted into the prepared skin bag and fixed by sewn to the fascia.

An unfavorable step in this surgical technique is the cutting of the tube to the correct length and the subsequent mating with the connection piece of the pot. As far as possible, no air bubbles should enter the hose. Also, the delivery end of the tube in the hollow organ may not move as possible.

The object of the invention is to provide a port catheter, by means of which the operation for implanting the port catheter is simplified. According to the invention, this is achieved by a port catheter having the features of claim 1.

In a port catheter according to the invention, the length of the tube over which this extends from the pot (= free length of the tube), changeable by the pot is rotated relative to the fastening part. Here, the tube is wound more or less far around the circumference of the pot or unwound from this. The attachment of the port catheter to the tissue of the human or animal body via the attachment part. Thus, the fastening part could be sewn to the fabric in a conventional manner. In advantageous embodiments of the invention, the fastening part comprises at least one fastening element which can be pierced into the tissue for attachment to the tissue. The attachment of the port catheter can be done, for example, subcutaneously. An attachment to the outside of the skin is conceivable and possible.

In a port catheter according to the invention, the tube no longer has to be cut to length during the implantation of the port catheter and subsequently plugged together with the pot, but rather the tube can already be connected to the pot at the beginning of the operation. After insertion of the tube, wherein its discharge end is arranged in the hollow organ, the free length of the tube can be changed by turning the pot relative to the fastening part.

For example, the length of the tube can be adjusted after the fastening part has already been attached to the tissue of the human or animal body. In addition or instead, the adjustment of the length can also be made prior to attachment of the attachment part to the tissue of the human or animal body.

An operation method for implantation of a port catheter thus advantageously comprises the following steps: The tube attached with its connection end to the pot is inserted with its delivery end in advance into the hollow organ until the delivery end has reached the desired location. In a further step, the pot is fixed by means of the fastening part on the tissue of the human or animal body, wherein before or after or both before and after attachment to the fabric, the free length of the tube is adjusted by rotation of the pot relative to the fastening part, in particular shortened becomes.

Advantageously, the implantation can be carried out so that the delivery end of the tube is initially inserted a little too far into the hollow organ. After attachment of the attachment part to the tissue of the human or animal body can the tube by turning the pot relative to the fastening part while shortening the free length of the hose in turn be withdrawn slightly until the discharge end is located at the intended location. This can also be done under X-ray control. Thus, an exact placement of the delivery end is made possible.

Advantageously, furthermore, the entire port catheter can already be filled with liquid, for example sterile saline solution, prior to implantation. An occurrence of air bubbles can be effectively avoided.

In an advantageous embodiment of the invention, the fastening part has an annular portion with which it surrounds the extending around the pot portion of the hose. The portion of the tube surrounding the pot can thus be covered by the fastening part, in order to counteract ingrowth of tissue, so that later removal from the body is easier. The surrounding the pot extending portion of the tube annular portion of the fastening part may have a passage opening for the passage of the tube. Preferably, the port comprising the pot and mounting member has a substantially closed outer surface without major gaps, scratches, or the like (apart from an exit port for the hose).

It is preferred if the hose is already connected to the pot at the factory, ie in the delivery state.

Further advantages and details of the invention are explained below with reference to the attached drawing. In this show:

Fig. 1 is an oblique view of a port catheter according to the invention, wherein the hose is shown only over part of its length; 2 and 3 is a side view and a view of the port catheter of Fig. 1, the

Hose only shown in a section adjacent to the port; Fig. 4 is an exploded view of the port catheter of Fig. 1;

5 and 6 are oblique views of the normal and parallel to the rotation axis cut port catheter of Fig. 1;

7 shows a schematic representation of a state during the implantation of the port catheter; 8 to 10 are oblique views of a further embodiment of the invention, in the standby position (Figure 8) and in the insertion position (Figures 9 and 10), wherein the membrane of the pot (1) is omitted. 11 and 12, a third embodiment in the standby position (Fig. 11) and the

Use position (Fig. 12), wherein the membrane is omitted.

A first embodiment of a port catheter according to the invention, which may also be referred to as infusion port, is shown in FIGS. 1 to 6. The port catheter comprises a pot 1, which in this exemplary embodiment has a pot bottom 2, a pot top part 3, between which a membrane 4 is inserted, which consists in particular of silicone. Inside the pot 1 is a chamber 5, in which the liquid to be supplied to the hollow organ of the human or animal body is introduced. For this purpose, the membrane 4 is pierced with an injection needle in the region of an opening 6 of the upper part 3 of the pot and the liquid is injected into the chamber 5. After the extraction of the injection needle, the puncture opening of the membrane 4 closes due to the elasticity of the material of the membrane 4th

With the pot 1, a tube 7 is connected, which is a catheter. The connection takes place in the region of a connection end 8 (see Fig. 5) of the hose 7, for example by the connection end 8 is attached to a connecting piece of the pot bottom part. The connecting piece 9 is located in a bore in the pot base 2 and is at least largely aligned tangentially. The tube 7 emerging from the bore in the pot bottom part 2 can thereby be guided around the outer surface 10 of the pot bottom part 2 without greatly changing the curvature.

The inner channel 11 of the tube 7 communicates with the chamber 5 of the pot 1, in the illustrated embodiment via the bore of the connecting piece 9 and a lateral extension 12 of the chamber fifth

The guided by the tube 7 into the corresponding hollow organ fluid is introduced in the region of a discharge end 13 of the tube 7 in the hollow organ. In the exemplary embodiment shown, the discharge end 13 of the tube 7 is closed at the end and has a lateral outlet opening 14 (cf., FIGS. 5 and 6), from which the liquid exits from the channel 11.

According to the invention, the port catheter further comprises a fastening part 15. The port 16 of the port catheter, which comprises the pot 1 and the fastening part 15, can be fastened to the tissue of the human or animal body via the fastening part 15. For this purpose, the fastening part 15 has at least one fastening element 17. In the embodiment shown, a single fastening element 15 is present on the fastening part 15, which rotates helically around an axis (which coincides with the axis of rotation 20 explained below) and which with its piercing end 18th is inserted into the tissue, whereupon the attachment by a rotation of the fastening part (about the axis of the screw-threaded fastening element 17) takes place. The cross section of the fastener 15 is flat in the illustrated embodiment, but could also have a different shape.

When attached to the body, the port abuts the tissue in a contact plane 19 (see FIG.

The attachment of the fastening part 15 on the tissue of the human or animal body can also be done in another way. For example, the fastening Part 15 also - as is known and customary in port catheters - are sewn to the fabric. For this purpose, the fastening part 15 could have sewing eyes as fastening elements.

The pot 1 is rotatable relative to the fastening part 15 about an axis of rotation 20. It can thereby the length of the portion of the tube 7, over which the tube 7 extends from the port 16 to the discharge end 13, be changed. For this purpose, a section of the hose 7 adjoining the connection end 8 is guided around a circumferential section of the pot 1. By rotation of the pot 1 relative to the fastening part 15, this peripheral portion of the pot 1 changes to the

The possible directions of rotation of the pot 1 relative to the fastening part 15 are symbolized in Fig. 1 by the double arrow 21 and the associated movement of the hose is indicated by the double arrow 22.

The annular portion 23 of the fixing member 15 surrounds a circular cross-section extending at right angles to the axis of rotation 20 outer surface 10 of the pot 1 at a distance to this, with a gap for receiving the tube remains. Subsequent to the portion of the hose 7 extending around the peripheral portion of the pot 1, the hose 7 passes through an aperture 24 in an annular manner

Section 23 of the fastening part 15. The extending around the peripheral portion of the pot 1 portion of the tube 7 is thus received in a apart from the passage opening 24 and a game for sliding guide between the pot 1 and the fastening part 15 substantially closed receiving space 25.

The pot bottom 2, the pot top 3 and the fastening part 15 may for example consist of titanium. The tube 7 may for example consist of silicone.

The axis of rotation 20 is preferably normal to the abutment plane 19. The port 16 advantageously has a low overall height in the direction normal to the abutment plane 19.

If the pot 1 has a diameter of at least 2 cm, then the adjustability of the free length of the tube 7 can be at least about 6 cm, if the tube 7 can be wound up by a maximum of one turn around the pot 1, as is preferred. In principle conceivable and possible, it would also be possible to allow a winding of more than one revolution (= more than 360 °) of the tube 7 to the pot 1.

For implantation of the port catheter into the human body, the delivery end 13 of the tube 7 being inserted into a hollow organ, for example a blood vessel, the tube 7 is already attached to the pot 1 at the beginning of the operation. Conveniently, the pot 1 and the tube 7 are filled prior to implantation, for example with sterile saline. As a result, the tube is introduced into the hollow organ. For this purpose, a conventional surgical method can be used, for example the selbinger Technology. When the delivery end 13 of the tube 7 is at the desired location, the tube 7 is temporarily fixed to the tissue, for example with a staple. The discharge end 13 of the tube 7 may be inserted somewhat further into the hollow organ, as it corresponds to the intended discharge point for the liquid. Before and / or after the following fastening of the fastening part 15 on the tissue of the human or animal body, the free length of the tube 7 is adjusted by turning the pot 1 relative to the fastening part 15. If the delivery end 13 has been inserted a little further than the intended delivery point in the hollow organ, so the tube after attachment of Befestigungssteiis 15 on the fabric of the body by rotation of the pot 1 relative to the mounting member 15 is still slightly withdrawn until the discharge end 13 the has reached the intended delivery point. This retraction is preferably carried out under x-ray control.

FIG. 7 shows, in a highly schematic representation, the port catheter during implantation, the tube 7 being inserted into a blood vessel 33. Entry into the human body takes place in the area of a skin opening 34, wherein the port 16 is to be inserted into a skin pocket. FIG. 7 shows the state in which the tube 7 has already been inserted into the blood vessel 33 to the desired location. As a result, the port 16 is attached to the tissue, wherein the free length of the tube 7 before and / or adjusted in the sequence, in particular, is shortened. The tube 7 may extend in the state shown in FIG. 7 to its discharge end 13 also something about the intended location in the blood vessel 33. After attachment of the port 16 to the fabric, the discharge end 13 can be withdrawn to the intended location by rotation of the pot 1 relative to the fastening part 15.

A further embodiment of the invention is shown in FIGS. 8-10. The difference from the exemplary embodiment described above consists primarily in the design of the fastening part 15. In this exemplary embodiment, this is designed in several parts and comprises a base part 26 on which hook-like fastening elements 17 can pivot are arranged, and a relative to the base member 26 in the direction of

This attachment part 27 has pairs of tabs 28, between each of which a pin is held, which passes through a slot 29 in the respective fastening element 17. By moving the actuating part 27 relative to the base part 26 in the direction of the abutment plane 19, the hook-shaped fastening elements 17 are pivoted from a ready position (cf., Fig. 8) into an insertion position (see Fig. 9 and 10). If the base part 26 in this case rests against the tissue, then the fastening elements 17 are inserted into the tissue and fasten in its inserted position the port 16 on the tissue.

The fastening elements 17 are mounted pivotably on an annular portion of the base part 26, which in turn surrounds the wound around the pot 1 portion of the tube 7 and has a passage opening 24 for the passage of the tube. In order to keep the actuating member 27 in the position in which the fasteners 17 are inserted into the tissue and attach the port 16 to the fabric, locking elements 30, 31 may be present, which act in the embodiment shown between the actuating member 27 and the pot 1.

To change the free length of the tube 7, the pot 1 is in turn rotated relative to the fastening part 15 about the axis of rotation 20 perpendicular to the abutment plane on the tissue.

Another embodiment is shown in FIGS. 11 and 12. Again, pivotable fastening elements 17 are arranged on a base part 26 of the fastening part 15. The pivoting of the fastening elements 17 in order to pierce them into the tissue takes place by actuating cams 32 of an actuating part 27 when it is displaced in relation to the base part 26 in the direction of the abutment plane. The pivotable mounting of the fastening elements 17 on the base part 26 can be done for example by means of film hinges. The actuating part 27 is secured against rotation with respect to the pot 1. For this purpose, it has guide recesses 35, which extend in the direction of displacement and receive the guide projections of the pot 1.

Various other types of fasteners 17 for attaching the fastener 15 to the tissue of the human or animal body may be provided. For example, fasteners could also be used with barb-like sections, which are inserted normal to the abutment plane 19 in the tissue. For example, these fastening elements could be arranged on an actuating part, which is displaceable relative to a base part of the fastening part 15.

A port catheter according to the invention could also comprise more than one pot ^'1, starts from each of which a hose. 7 The fastening part 15 could in this case have a base plate and for each of the pots 1 a surrounding annular portion to support the respective pot 1 rotatably. The base plate could, for example, be sewn to the tissue of the human or animal body and, for this purpose, have 17 eyelets as fastening elements. Also fasteners formed in another way could be provided again.

Conceivable and possible, it is also to provide a lock to lock the set rotational position of the pot 1 relative to the fastening part 15. For example, such a locking could be done by means of a depressible pin. Also, the rotatability of the pot 1 relative to the fastening part 15 could be locked, ie gradually overcoming the holding force of resilient locking elements. _{l C} N

L e g e to the reference numbers:

1 pot 18 stinging

Pot bottom 19 Plant level

3 pot top 20 rotation axis

4 membrane 21 double arrow

5 chamber 22 double arrow

6 opening 23 annular portion

7 hose 24 passage opening

8 connecting end 25 receiving space

9 Connecting piece 26 Basic part

10 outer surface 27 actuating part

11 channel 28 tab

12 lateral extension 29 slot

13 discharge end 30 locking element

14 outlet opening 31 latching element

15 fastening part 32 actuating cam

16 port 33 blood vessel

17 fastener 34 skin opening

35 guide recess

Claims

claims:

Port catheter for introducing a liquid into a hollow organ of a human or animal body comprising a pot (1) having an inner chamber (5) for receiving the pot (1) supplied liquid, and one at a terminal end (8) the tube (7) connected to the pot (1), which has an inner channel (11) which communicates with the chamber (5) of the pot (1) and through which the liquid can be conducted into the hollow organ, characterized in that

Port catheter further comprises a fastening part (15) which can be fastened to the tissue of the human or animal body, wherein for changing the length of a subsequent to the terminal end (8) portion of the hose (7), via which the hose (7) at least one Peripheral portion of the pot (1) extends, the pot (1) relative to the fastening part (15) is rotatable.

2. Portkatheter according to claim 1, characterized in that the pot (1) and the fastening part (15) comprehensive port (16) of the port catheter in a contact plane (19) on the tissue of the human or animal body is attached to this attachable bar and the pot (1) relative to the fastening part (15) about an axis of rotation (20) is rotatable, which is aligned at right angles to the bearing plane (19).

3. Portkatheter according to claim 1 or 2, characterized in that the pot (1) has a circular in cross-section outer surface (10) for conditioning of the pot (1) extending portion of the hose (7).

4. port catheter according to one of claims 1 to 3, characterized in that the fastening part (15) has an annular portion (23) with which it surrounds the pot (1).

5. port catheter according to claim 4, characterized in that the annular portion (23) of the fastening part (15) surrounding the pot (1) extending portion of the tube (7).

6. port catheter according to claim 5, characterized in that the annular portion (23) of the fastening part (15) has a passage opening (24) which is penetrated by the hose (7).

7. port catheter according to claim 6, characterized in that between the annular portion (23) of the fastening part (15) and the pot (1) apart from the passage opening (24) in the annular portion (23) substantially closed receiving space (25) for the around the pot (1) extending portion of the hose (7) is formed.

8. port catheter according to one of claims 1 to 7, characterized in that the pot (1) has a membrane (4) which is pierceable for supplying the liquid into the chamber (5) of the pot (1) by an injection needle.

9. port catheter according to one of claims 1 to 8, characterized in that the fastening part (15) has at least one einstechbares in the tissue of the human or animal body fastener (17).

10. port catheter according to claim 9, characterized in that a single, helical thread around an axis circumferential fastener (17) is present.

11. port catheter according to one of claims 1 to 10, characterized in that the hose (7) is already connected to the factory with the pot (1).

12. Portkatheter according to one of claims 1 to 11, characterized in that the hose (7) by rotation of the pot (1) relative to the fastening part (15) over a maximum of one revolution about the pot (1) can be wound.