Title: Apparatus for removal of accumulations of fluid or air below skin level-

Technical Field

The invention relates to an apparatus for removal of accumulations of fluid or air below skin level at a human or an animal, the said apparatus includes a hypodermic needle for penetration of the skin and a suction and collection device for suction of the fluid through the hypodermic needle. The said apparatus is adapted for removal of e.g. accumulations of fluid or air being a result of e.g. surgery, or solely accumulations of fluid in e.g. knees or other tissue with cavity or in regions of organs, e.g. gastrointestinal regions or in the heart/lungs.

Background

Often, accumulation of fluid below the surgical wound appears after various types of surgery, especially after surgery for breast cancer. Also, accumulations of fluid appear frequently after vascular surgery, e.g. in the inguinal region. Further, accumulations of fluid may appear in the knees, in the lungs, around the heart, or in the abdominal cavity, e.g. in case of infectious diseases or heart, lung, or liver diseases. Accumulations of fluid in the lungs or in the abdominal cavity also often appear in patients suffering from heavy cancer. When emptying accumulations of fluid in such cases various systems are used today, inter alia just a hypodermic needle mounted on a syringe or various joint systems with three-way taps, hoses, hypodermic needles, and syringes. If an outlet hose has been mounted, it is today often led to an open vessel (capsule, plastic/ glas vessel) or a collection bag.

When using a hypodermic needle on a syringe the emptying of the fluid is impeded, inter alia because the hypodermic needle, which is mounted on the syringe, needs to be removed several times with a view to emptying the fluid suctioned. If a three-way tap has been mounted, the said three-way tap needs to be alternated between suction and emptying position, simultaneously with the mounted syringe being actively pulled out in order to suck the fluid and subsequently being pushed in with a view to emptying the syringe through an outlet, which is generally led through some sort of hose to an open vessel (capsule, plastic/ glas vessel) or a collection bag, e.g. of plastic. Finally, the out- let hose must also be handled in relation to the outlet.

When emptying fluid after breast surgery (serum collection) it is often an advantage to be two persons. One of the persons performs the suction by holding the plunger handle of the syringe out whilst the other person uses the hand to move the fluid towards the spot, where the hypodermic needle has penetrated the skin. This procedure allows a more complete emptying without penetrating the skin several times and thus limits the risk of infection. This method also enables the creation of a negative pressure inside the cavity, where the fluid has been accumulated. The said negative pressure causes the surface of the skin to be sucked towards the breast wall. This increases the possibility of adhesion and thus prevents a new accumulation of fluid.

The procedure, as it is generally performed today, for emptying fluid or air from cavities below skin level can be divided into:

A. Hypodermic needle mounted on a syringe 1. Introducing the hypodermic needle into a cavity with fluid or air.

2. Fixing the puncture needle in a certain position and often with a certain desired depth of the needle tip below the skin.

3. Pulling back the plunger handle of the syringe with a view to filling the syringe with fluid/air from the cavity. 4. Separating the syringe and the hypodermic needle.

5. Emptying the contents of the syringe into the collection vessel (capsule, plas- tic/glas vessel)

6. Assembling the hypodermic needle and the syringe again.

7. Repeating the suction of fluid or air from the cavity. 8. Repeating the procedure in item 3-7 until all fluid or air has been sucked from the cavity.

B. Hypodermic needle mounted on a syringe with a three-way tap

1. Introducing the hypodermic needle into a cavity with fluid or air. 2. Fixing the puncture needle in a certain position with a certain depth of the needle tip below the skin.

3. Pulling back the plunger handle of the syringe with a view to filling the syringe with fluid/air from the cavity.

4. Turning the three-way tap away from initial position. Pushing down the plunger handle of the syringe in order to empty the contents of the syringe into the collection vessel: capsule, plastic/glas vessel, or collection bag.

5. Turning the three-way tap back to initial position with a view to repeating the procedure as mentioned in item 3-5.

6. Repeating the procedure in tern 3-5 until all fluid or air has been sucked from the cavity below the skin.

All in all several sub procedures, which may be difficult to perform by a single person, especially when the system has to be separated. (A item 3-7). This may result in incomplete emptying of fluid or air as well as non-observance of the aseptic procedure, e.g. backflow of fluid or air from the hypodermic needle into the cavity, with a subse- quent higher risk of infections. In addition, handling of the evacuated fluid in open vessels is both unhygienic and unpleasant for the patients to experience.

US patent No 4,435,170 describes a blood collection vessel comprising a handheld control mechanism tightly connected to a rigid collection tube. A hose extends through the control mechanism. The hose is connected to the rigid collection tube and can be more or less clamped together by means of a clamping device. In the other end the hose is connected to a collection vessel connected to a vacuum source. The collection tube is equipped with side holes in the front end and is thus made for suction of tissue fluid from open cavities, i.e. typically in connection with surgery.

Disclosure of the Invention

The object of the invention is to provide an apparatus which enables penetration of intact skin in order to suck fluid from a closed cavity into a vessel during one single pro- cedure and without changing or separating the individual parts.

According to the invention this is obtained by connecting the hypodermic needle with the mouth of a pistol-like handle and in the pistol-like handle by connecting the said hypodermic needle with a first end of a conduit, the other end of which is connected to the suction and collection device, and by the handle having a closing mechanism, which co-operates with the conduit and is activated with a view to opening for passage of the fluid, when a trigger belonging to the pistol-like handle is activated towards the effect of a driving means, which biases the trigger into a closed initial position.

The use of a hypodermic needle, which is appropriately sharp, in combination with the pistol-like handle enables a relatively easy and controlled penetration of intact skin, as

the user has a good grip on the apparatus due to the pistol-like handle, and in addition the activation of the trigger enables an effective controlling of the suction process. The handle enables a relatively precise positioning of the needle tip both as regards direction and depth of penetration in relation to the underlying tissue, and additionally the user can use the other hand to work the skin area in question and push fluid forward to the needle tip. Thus, it is possible to establish vacuum in the cavity and thereby keeping the surfaces together, so that an acceleration of the adhesion of the surfaces in question is ensured, if so desired. During the extraction of the hypodermic needle it is still possible to maintain suction at the needle tip and thus ensure that vacuum is left in the cavity. Moreover, the presence of vacuum in the cavity results in a rupture of the small blood vessels in the surface. The said minimal damage to the surface may advance subsequent healing and thus reduce the probability of fluid being developed subsequently. The said procedure is unambiguous and repeatable so that the emptying of fluid or air from the cavity may be performed in the same way each time and by a single person by use of the apparatus according to the invention, which is a closed system with vacuum, and the parts of which do not require separation during use, and thus the probability of backflow of fluid or air into the cavity of the patient during the treatment is reduced and thus also the risk of infection. The closed system also means that malaise due to the smell of the fluid is reduced. The trigger of the pistol-like handle en- ables both a light touch with the motion of the hypodermic needle and control of flow rate of the fluid or air through the conduit.

According to the invention the closing mechanism can be a valve means with a valve body, which is brought to a closing position by the vacuum of the suction and collection device. This enables easy and economical production of the closing mechanism.

Further, the conduit is a flexible hose with one end directly connected to the hypodermic needle and the other end connected to the suction and collection device, and in addition the closing mechanism of the handle may be a hose clamping device. This en- sures an especially tight connection between the hypodermic needle and the suction and collection device.

Appropriately, the hypodermic needle can, according to the invention, also be removably connected to the mouth of the handle via a Luer coupling.

According to the invention the hose clamping device can include a fixed abutment for the hose in the handle, whereas the trigger is hinged around an axis of rotation and biased into an inactivated position around the said axis of rotation by means of a spring device, and the said trigger has a protrusion for pressing the hose towards the said abutment and clamping the hose in this position and releasing the hose by manual activation of the trigger in order for the trigger to turn around the axis of rotation against the direction of the biasing force of the spring device. Thus, an especially simple closing mechanism is obtained in connection with a hose connection between the hypodermic needle and the suction and collection device.

According to the invention, the suction and collection device can be a vacuum vessel with a vacuum obtained in advance, whereby the use of a separate vacuum source is avoided.

Finally according to the invention, the vacuum vessel can have a closable inlet stub, through which the vacuum vessel is connected to the other end of the hose, so that backflow is avoided.

Brief Description of the Drawing

The invention is explained in detail below with reference to the drawing, in which

Fig. 1 schematically illustrates an apparatus according to the invention, and

Fig. 2 illustrates a pistol-like handle with a hose clamping device, in sectional view, and

Fig. 3 schematically illustrates a closing mechanism, the function of which may be controlled by vacuum.

Detailed description of the Invention

The apparatus illustrated in Fig. 1 comprises a pistol-like handle, which is illustrated with the general reference number 1 , and which comprises a grip 2, a trigger 3, and a barrel 4. At the front end of the barrel a hypodermic needle 5 is mounted, the said hy- podermic needle 5 being connected via a Luer coupling 6 with a hose 7, which partly extends through the barrel 4 of the pistol-like handle 1 and passes out and is con-

nected to a vacuum vessel, illustrated with the general reference number 8. The vacuum vessel is of a commonly known type such as the one described in US patent No 4,376,439. The vacuum vessel has a schematically illustrated device 9, which is constructed to show, whether there is vacuum of a certain size in the vessel 8, and thus also to show, when this is no longer the case due to the fact that the vessel has been filled to a predetermined limit. The pistol-like handle 1 , illustrated in sectional view in Fig. 2, is made of an appropriate plastic material and has a lid 10, which enables easy access to the inner handle. The said lid is cast integral with the other part of the handle through a plastic hinge and is constructed so as to be fixed with the other part of the handle by a snap connection, which has not been illustrated in details.

The trigger 3 is made of the same material and has a pin 11 , which is led through a hole 12 at each side of the grip 2.

Thereby the trigger 3 is tumably fixed on the grip 2. As is illustrated in sectional view in Fig. 2, a spring device 13 has been placed between the grip 2 and the trigger 3, the said spring device 13 pushing the trigger 3 clockwise around the pin 11 , resulting in an protrusion 14 on the trigger 3 being pushed up against an abutment 15, so that the hose 7, which passes out through a hole 16 in the barrel 4 and in between the abut- ment 15 on the barrel 4 and the protrusion 14 on the trigger 3, is clamped together between the protrusion 14 and the abutment 15. By this, the passage through the hose 7 is closed between the protrusion 14 and the abutment 15. When activating the trigger 3, i.e. by pressing the trigger 3, so that it is turned anticlockwise around the pin 11 , the hose 7 is released from the clamping and the passage is opened.

The hypodermic needle 5 is a common type with a sharp needle tip 17.

The hose 7 is connected to the vacuum vessel 8 by means of an additional Luer coupling 18, and an inlet stub 19 of the vacuum vessel 8, which inlet stub 19 is preferably of rubber, may be clamped by means of a clamping device 20, which is illustrated with a broken line.

When using the apparatus the user grips around the grip 2 and the trigger 3 of the pistol-like handle 1 and manoeuvres the hypodermic needle through the skin into the cav- ity from which the fluid or the air is to be removed. The grip of the pistol-like handle 1 around the grip 2 and the trigger 3 enables an easy handling of the apparatus with one

hand while the other hand is available for working the surrounding areas of the skin and the cavity in question. The vacuum in the vacuum vessel 8 is easily connected to the inner hypodermic needle and thus the cavity in question by activation of the trigger 3, so that fluid is sucked out, which is transferred to the vacuum vessel 8 through the hose 7. By means of the apparatus according to the invention, the treatment is performed in a closed system during the entire process, the said system operating with a vacuum, which is independent from other vacuum sources and delivered only together with the vacuum vessel 8. When it is desired to terminate the flow of the fluid and the air through the tube 7, the trigger 3 merely has to be released.

The pistol-like handle may have many different shapes and may be formed in different ways. In Fig. 3, the trigger is shown with the reference number 3 and the fulcrum pin 11. The trigger 3 is shown in the activated position. The trigger 3 is here connected with a piston-like valve body 20, which is slidably fixed in a valve house 21. Together with the valve body 20 the valve house 21 define a space 22, which is connected with a piece of conduit 23, which is connected to the vacuum vessel 8, and a piece of conduit 24, which is connected to the catheter 5. In the illustrated position of the trigger 3 it has been moved in the direction shown by the arrow 25, thus creating a vacuum connection between the vacuum vessel 8 and the hypodermic needle 5 through the space 22. At release of the trigger 3 the piston-like valve body 20 is pulled in the direction shown by an arrow 26, viz. towards right in Fig. 3, until a flat protrusion 27 abuts on the opening of the piece of conduit 24 and thus closes the connection. In this position the trigger 3 is in the inactivated position. The use of a metal spring device is thus avoided.

The illustrated valve device is only illustrated schematically and may have many different shapes.

The apparatus has been described with reference to the preferred embodiments. Many changes can be made without deviating from the idea of the invention. E.g. the hypo- dermic needle 5 can be fixed to the pistol-like handle, and the individual parts can be made of such materials that they are disposable.