MXPA00003800A - Connecting device for medical purposes - Google Patents

Abstract

Device for external connection of the bloodstream of a patient to an external circuit or a fluidum source for medical purposes, comprising:a main body (1) with at least a first opening (8, 8') being surrounded by (a) first sealing surface (-s) (9, 9') and being adapted to be protected by a removable protective member (24), and a connecting member (10) with at least one second opening (12, 12') being arranged to be protected by a protective body (27) which is removable with respect to the connecting member, wherein the connecting member (10) is connectable to the main body (1) under simultaneous removal of the protective member (24) and the protective body in order to obtain leakproof connection between said openings, wherein the main body (1) is provided with holding elements (6) forming a guide (7) which is open in both ends for the protective member and the connecting member respectively. The invention also concerns a connecting unit for the connecting device.

Description

CONNECTION DEVICE FOR MEDICAL PURPOSES DESCRIPTION OF THE INVENTION This invention concerns a device according to the preamble of claim 1. It also concerns a connection unit and a protection unit for use in such a device. WO 92/13590 (corresponding to SE-3-467 769) concerns a device, wherein a housing with inner sealed surfaces is provided around the connecting openings which are adapted to cooperate with the outer sealed surfaces around the openings conductors in a coupling member which communicates with an external circuit. The sealed surfaces of the housing as well as the connecting member are covered and protected by the protective members in an unconnected position which in the connecting process are adapted to withdraw from and thereby unclog the respective sealed surfaces to achieve a tight connection or leakage proof. The purpose of protecting sealed surfaces is to avoid contamination of these as well as channels and thus avoid or at least radically reduce the risks of infection REF .: 119044 found by a patient using the connection device. The device known from the cited document has good operation but is relatively complex, which has resulted in complicated and therefore its production is relatively expensive. It is an object of this invention to put the problems aside and provide a development of the known device which has high standards of hygiene, that is simple to produce, easy to handle and possible to produce at a reduced cost. These objectives are achieved in a device like the previous one by the characteristic of the portion characterized in claim 1. By lfi the fastening elements forming a guide that is open at both ends for the parts to be connected (to the protection and protection member). to the connection member respectively) it is achieved that the connection procedure can be obtained by the displacements of the The part to be connected along the guide in a single movement of movement, whereby with this simple movement, as an example in case of connecting the connecting member, at the same time the protective member is removed from the main body and by Consequently its active position. The displacement of the connecting member to the connection position in this manner results in the cooperation obtained between the respective sealed surfaces at the same time as the protective body is brought from the position where the second sealing surface (surfaces) is protected. . It should be noted that a relative movement between the parts is desired and that in practice the protective body can be fixed while the other parts are subjected to a movement. When disconnecting the connection member after completing the treatment, the invention provides a corresponding simultaneous positioning of the protection member .. The connection member therefore does not have to be lowered into a housing to obtain the connection position, which on the other hand this is the case with the prior art, where the housing is provided with internally sealed surfaces. This results in a considerable simplified elaboration compared to the known device, since the respective sealed surfaces are located on a surface extending along the guide, resulting in an essentially simplified production. A further advantage is that the hygienic standards are further improved, since, according to the invention, no protective cover or the like has to be removed from the main body before the connection procedure, thus eliminating the need to expose the interior of the housing before it is possible to connect to the connection member. Instead, the connection can be made with a "closed" main body completely. The main body therefore has no movable part, which results in a simplified and more economical manufacture and higher standards of hygiene and safety, in particular when applied as a graft (claims 5-8, etc.). Claim 2 declares a preferred embodiment of guidance, but also the construction according to claim 3 is adaptable and advantageous in certain cases. By means of the sealed surfaces that are flat, the elaboration is simplified and the resulting product is more economical.

The feature according to claim 5 concerns the use of the device according to the invention as a so-called blood vessel valve which is useful for medical purposes where access to blood flow is desired, for example when taking samples of the flow blood, in the administration of different medicines, in nutrition, in cellular treatment, the determination of levels of substances in the blood flow, etc. The means for supporting the growth can be as a flange, longitudinally oriented elements or the like. An implanted main body will have the surface level sometimes on these media and with the top part with the guide etc. on the surface level and being accessible to connect the respective element. The construction according to the invention with an open guide configuration in this connection results in a simplified handling for the patient and / or medical personnel. During the use of the blood vessel valve for CRRT (Chronic Renal Replacement Therapy), dialysis / blood treatment and in a number of different applications, that is, connecting other types of artificial organs such as artificial kidneys, in exchange for gas such as oxidisation, etc. there are two coupling means and two first and two second openings in the device according to the invention (claim 6). The construction of the main body whereby efficient extraction of channels is allowed such as effectively reducing the flow resistance in the device. Taken together, the device according to the invention is particularly preferred as a valve of the blood vessel. The feature according to claim 7 allows a simple and easy production to handle the means for mutual support. The feature according to claim 8 results in that the coupling means are connected to each other in a simple manner when the protection member is placed in its active position which in case of a graft ensures that at all times there is a flow through of the device, thus eliminating the formation of coagulated blood. An aspect of the invention that considerably simplifies the handling of the device is defined in claim 9 and particularly in claim 10. For this purpose the protective body thus comprises a guiding means for simplified application, and when the fastening means that opening and securing are present to cooperate with the main body, the user thus only needs to activate these means to obtain the proper guidance of the connecting member (or any other part) where the means of the device will be essentially simpler to handle by the patient or the medical staff in case of an implanted main body.

The feature according to claim 11 allows direct access to blood flow through a membrane that is penetrable with an injection needle. The feature according to claim 12 results in advantageous sealing functions. The invention also relates to a connection unit and a protection unit respectively for use with a device according to any of claims 1-12. The invention will now be described in more detail with the background of the embodiments and with reference to the accompanying drawings in which: Figures show a main body in a side view, and an end view and a flat view from above respectively , Figures 2a-2c show a connection member in a? flat view from above, a longitudinal section and an end view as seen in the direction against the direction of insertion respectively, Figures 3a-3b show a protection member in a flat view from above and a longitudinal section respectively, the Figure 4 shows a main body and a protective body with connecting member applied before an imagined connection process with the protective body having an open fastening means, Figure 5 shows the protective body having a closed fastening means, Figures 6a-6c show a modified main body in a side view, and an end view and a flat view from above respectively, »Figures 7a - 7b show a modified connection member in a flat view from above and in a longitudinal section, Figures 8a-8c show a membrane unit in a flat view from above, from below and in a cross section respectively, Figure 9 shows the modified main body of Figure 6 and a modified protection body that are applied to the connection member before an imagined connection process, and Figures 10a and 10b show the protective body of Figure 9 with the sliding in the different positions of displacement. In the figures la - le a main body having opposingly directed coupling means 2 and 2 'is indicated, where through the channels 3 and 3' respectively are connected to the first openings 8 and 8 'respectively that are placed in a plane extending in parallel with the longitudinal direction of the main body, which is more evident in Figure Ib and le. In the areas around the first openings 8, 8 'the portions of the plane comprise the first sealed surfaces 9 and 9' respectively. In Fig. Ib, the fastening elements 6 in the main body 1 are also shown, which are L-shaped, longitudinal, internally directed edges that, together with the plane, provide the sealed surfaces 9, 9 'forming a linear guide 7 (FIG. Ib) to cooperate with the elements that wish to connect to the main body. He does not. 4 indicates engaging the coupling openings that allow access to the guide 7 from the side in a manner that will be explained further below. When the main body according to the invention is desired to be implanted, it is preferred that the means 5 for supporting the growth of human tissue are placed where the means in this case are protrusions like flanges directed externally with possible holes penetrating the material. See Figure 6c, where in the growth holes / suture holes 45 'are made in the flange-like means 45.

From the figure it is also clear that the main body is made with an over-structure 20 for connection purposes with respect to a basic plane 21, which in turn is located below the plane including the first sealed surfaces 9, 9 '. Figure 2a shows a connection member 10, comprising the 11, 11 '(indicated with interrupted lines) for connection to an external circuit on a threaded portion 13 for the connection of pipe or the like. The connecting member 10 is additionally provided with the fastening means 17 formed as laterally directed linear flanges which are desired to cooperate with the fastening elements 6 of the main body (see particularly Figure Ib). Additionally the no. 14 indicates the laterally directed clamping projections for cooperating securely with the openings 4 in the main body (see Figure la). He does not. 18 indicates securing projections which prevent a connecting member 10 from being carried through the guide 7 of the main body, and these projections are desired to cooperate with the projection cavities 19 in the main body (see FIG. Proper positioning of the connecting member in the main body. The corresponding also applies to other desired parts to connect to the main body, for example the protection member (see Figures 3a-b). The clamping means 17 in this case provides the essentially centrally located pressure portions 15 which are comprised of somewhat domed elastic portions of the strips 17, the pressure portions 15 being laterally spaced apart from the main part of the connecting member 10. In use, these portions 15 will guarantee the safe pressure of the sealed surfaces against one another allowing adequate absorption of the possible play in the fasteners of the main body. In Figure 2b the drawing of one of the conduits 11 within the connecting member is shown more clearly from the second opening 12 with the second surfaces sealed around the threaded portion 13. From Figure 2c the construction of the fastening means 17 it is shown in more detail and is designed as guide tabs similar to a strip, and the securing projections 18 which through its cooperation with the cavities 19 ensure fixation and correspondence with respect to the arrangement of openings. The interrupted lines indicate the second openings 12, 12 ', and 22, 22' indicating the respective second sealed surfaces.

Figure 3a shows a protection member 24 with the means 14, 15, 17 corresponding to the connection member. It is further shown that the protection member is essentially similar to a plate having a transverse oblong cavity, which in the applied position comprises the connection channel between the openings 8, 8 'in the main body to ensure the continuous flow through of the main body. He does not. 26 indicates the sealed surface surrounding the cavity 25 (best shown in Figure 3b) and which cooperate with the corresponding sealed surfaces in the main body. Figure 4 shows a protective body 27, which also functions as a guide body with respect to the connection / disconnection procedures, whereby no. 28 indicates a linear guide which corresponds to and is desired to coincide with the guide 7 of a main body 1 which is inserted in a cavity 29 which is adapted for that purpose and which is thus desired to receive the main body 1 around its upper structure twenty . { see Figure la), whereby the thickness of the material of the protection body in the area of the guide is adapted to correspond to the distance between the base plane 21 of the main body 1 and the surface including the sealed surfaces 9, 9 ' The protective body - guiding body 27 also includes a securing arm 31, which is rotated in the main part of the body with the no. 32 and what is provided with a retainer means 33 for cooperating with a retaining projection 34 on top of the main part. The laterally directed projections are adapted 30, in the inserted position of the main body 1 and the turned-up position of the securing arm 31, to penetrate the openings 4 in the main body 1 and whereby manually one securely holds the main body, on the other hand pressing the clamping projections 14 belonging to a protection member 24 applied internally in the main body in such a way that they will be disengaged from the respective opening 4. Thus, the protection member 24 is thus independent of the main body 1 and can be removed. This is achieved by the connecting member 10, which is placed in the guide 28 of the protective body 27 which is carried upwards as seen in the figure, whereby, at the same time, the protective member 24 will come out of the main body 1 and will be carried upwardly in the upper part of the guide 28. A continuous insertion of the connecting member will result in the projections 18 terminating in the protruding cavities 19 while simultaneously the clamping projections 14 will enter the level with the openings that are the majority in the bottom of the figure. A final grip will be obtained at the opening of the arm 31, when the projections 30 are removed from the openings 4 whereby a suitable and secure securing of the connecting member 10 in the main body 1 is ensured. The protective body can now be removed. of the main body through the arm 31 that is turned downwards and the protective body is carried laterally away from the main body. Through the invention thus a very simple and safe interconnection is obtained from - as an example in the case of the valve of the implanted blood vessel having two couplings - a position with function of the active passage through the channel of the protection member to a position with the connection member connected. To ensure pickup of the connecting member and the protection member in the direction of travel, and whereby separation in a longitudinal direction of these parts in relation to the interconnection is avoided and at the same time simplifying the movement process, a sliding movement it is preferably positioned to adapt so as to move in the guide of the protective body and which comprises one of the manual means for controlling the position of the elements in the direction of displacement, on the other hand for the effect of the common displacement in the form of a "thumb grip" or similar. This arrangement guarantees a limited tension to the integration of the skin with the main body. To connect an external circuit, a patient having an implanted main body will therefore require a connection unit that includes a connection member applied to and protected by a protective body for the connection procedure, and after completing the treatment it you will need • a protection unit consisting of a new protection member applied to and protected by a new protection body. Both units are advantageously articles of simple use. From Figure 5 the design of the protection body is shown - the guide body 27 has an assurance arm secured and rotated upwardly 31. The release of the coupling member and by the shape of the membrane member of the main body is achieved in correspondence with what has been said above with respect to the protection member. When a member, a coupling member, a protection member or membrane member, is applied to the main body, the insertion movement is opposite to the movement of the member to be replaced in the embodiment shown. It is not excluded, however, that the same insertion movement is used. In that case the clamping arrangement in the main body is modified. In the modified main body 41 in Figure 6a-c the external coupling means 42 and 42 'are directed A little down obliquely to improve flow through the channels and facilitate placement to the implantation. In this case there are only two coupling openings 44 located diagonally to ensure safety against a wrong connection. He does not. 44 'concerns an open-shaped guide as a hole of an externally open shape for cooperating with a clamping projection directed laterally in the corresponding guide body / guard body. He does not. 59 concerns in this case only two diagonally located projecting cavities. Also these arrangements are intended to ensure an adequate connection of the different details. The somewhat modified connection member 50 in Figure 7a and b is provided are differently located threaded portions 53, which in this case with their channels 51 are comprised of generally straight continuations of the channels 43 and 43 'in the main body (see Figure 6a) which provides a reduced flow resistance in the device and whereby the performance is improved and the tendency to form thrombi is also reduced. Additionally, in the connecting member, there is only one securing projection 58 and the clamping projections 54 and the pressing portions 55 that are located diagonally. In total this results in eliminating the misalignment of the coupling member in the main body. An additional advantage with the arrangement of the channel according to the invention is that it allows access to the channels in the main body and to the bloodstream for "thrombectomy", that is, the withdrawal of coagulated blood or the like without surgery. The invention can be modified within the scope of the following claims and can not be limited to the modalities shown. The invention can thus be used in a device with a single coupling and then as a graft as well as a hose coupling for external use of the human body. Also the components formed differently and others can be arranged to be connected to the main body, for example a membrane unit which can have a construction essentially as the shield member 24 but which has a penetrable membrane which limits the channel 25 of the environment. The membrane can in a manner known per se penetrate with a needle to allow the blood sample or introduction of drugs, etc. in the bloodstream. The membrane unit 80 in Figures 8a-c thus includes a main part 80 'having a body 80' with a transverse hole in which a penetrable membrane 81 is inserted in a sealed manner. As the case with the protection member in Figures -3a-b has the cavity 25, a connecting channel 81 is provided which in this case is formed of the material of the membrane, whereby a sealed surface 82 is placed around the channel 81. This arrangement results in the secure sealing effect being obtained between this surface 82 and the corresponding surface of the main body, eliminating the need for surface treatment of the surfaces. A membrane unit of this type can also be allowed to remain, at least for certain periods, in an implanted main body and thus replace the particular protection members (Figures 3a-b) so that there is no need for an interconnection between the before and after parts for example of the blood sample or the administration of medication. As alternative separate membrane units can be connected to a connecting member through a hose (hoses). Figure 9 shows a mounting of the modified parts showing the protective body 57 with a sliding displacement 84 mounted on a main body 41 and on a protection member and on a connecting member 50. The no. 94 indicates a cavity in the protection body that forms a channel for the connection between the conduits 51 of the connection member. This construction allows the pre-filling of the channels in question with a liquid such as a saline solution before the application of the connecting member to prevent the introduction of air into the bloodstream resulting in a greater additional safety against thrombi. Figure 10 graphically shows a protection body 57 with the sliding displacement 84 in an initial position, for example with the connection member applied (not shown) to be applied to a main body. The cover portion 85 covers and prevents handling with securing and stopping elements, mainly a locking tab 86 with which it is placed in a first securing cavity 87 in the protective body and in a first and second ratchet 89 and 90, where the first in this position cooperates with a first recess 91. By connecting a connection member for example, the manual holder 93 is carried to the right in the figure, whereby the first ratchet is released from its cavity. retention 91, after sliding completely can be taken to the right. In the right position, in Figure 10b, the locking tab 86 cooperates with a second securing cavity 88, which is designed as an assurance catch to prevent left movement in the figure and the second ratchet 90 cooperates with the second retention cavity 92. In this way the protective body can not be reused without authorization so that the risks of infections by using potentially infected material are avoided. Protective bodies correspondingly constructed can be used to apply all additional parts. The construction of the details may deviate from the modalities shown. The guide can therefore be placed differently, for example with the means corresponding to the fastening elements 6 instead of being placed on the connecting member and vice versa. The guide can be bent, for example in a circular manner, and the sealed surfaces can be provided on a curved surface as observed perpendicular to the connection direction. The extraction of the channels can be arranged differently with for example the channels extracted in the same direction instead of in opposite directions. The placement of and provision of fastening means such as the clamping lugs, the securing projection etc. they can deviate from what is shown. Also the elements for releasing a secured fastening connection member or the protection member can be varied with respect to construction and location. The device can be used as a graft or as a separate coupling device having one or two protruding couplings as well as openings and conduits in the respective portion. The invention provides several advantages in which only those which in construction provide convenient, painless and safe access to the bloodstream are mentioned, so that it can be used advantageously by the patient at home instead of using specialized personnel in a hospital. This is also the result of using the spontaneous flow as the propellant, ie the use of the heart as a pump to propel the blood through the blood treatment equipment or the like and facilitated by a device according to the invention is possible. The materials that can be used are biocompatible if needed for the application in question. The construction according to the invention is made with well-adapted synthetic materials, and possibly has surfaces that deal with the blood and / or biocompatible coatings for all the parts in question. The parts can then be comprised of disposable articles that are possible to produce at a low cost. The processing in another material such as titanium or titanium alloys, which have possible surfaces that provide blood and / or biocompatible layers for the main grafting body can also be considered.

It is noted that in relation to this date, the best method known to the applicant to carry out the aforementioned invention, is the conventional one for the manufacture of the objects or products to which it refers.

Claims (18)

1. Having described the invention as above, the claim contained in the following claims is claimed as property: 1. A device for external connection of a patient's bloodstream to an external circuit or source of fluid for medical purposes, comprises: a main body with at least a first opening surrounded by a first sealed surface and communicating with the outer coupling means that is connectable to the bloodstream, wherein in an unconnected position, the first sealed surface (surfaces) is (are) adapted to be protected by a removable protection member, and a connecting member with at least a second opening surrounded by a second sealed surface and to communicate with a circuit or source which in an unconnected position is arranged to be protected by a protective body which is removable with respect to the connecting member, where the connecting member is connectable to the main body under the simultaneous removal of the protection member from the first surface < * e sealing (surfaces) and the protective body from the second sealing surface (surfaces) to obtain cooperation between these surfaces and mainly the hermetic connection between the openings, characterized in that the main body is provided with the fasteners for the cooperation with the securing means in the protection body and the connection member respectively, the fastening elements form a guide that opens at both ends for the protection member and the connection member respectively.
2. 2. A device according to claim 1, characterized in that the guide 7 is linear.
3. 3. A device according to claim 1, characterized in that the guide 7 is bent.
4. 4. The device according to any of claims 1-3, characterized in that the unpaved surfaces are flat.
5. 5. The device according to any of claims 1-4, characterized in that the main body is grafted and is provided with means similar to a flange which preferably have several transverse holes, to support human tissue growth.
6. 6. The device according to any of claims 1-5, characterized in that there are two coupling means and two first and two second openings.
7. 7. The device according to any of claims 1-6, characterized in that either the main body in one hand and the connecting member and / or the protection member in the other hand is provided with the retaining means for securing mutually in the respective applied position.
8. 8. The device according to claim 6 or 7 when dependent on claim 6, characterized in that the protection member is provided with a channel for interconnecting the two first openings in the applied position.
9. 9. The device according to any of claims 1-8, characterized in that the protection body is provided with means for cooperating with the main body so that the connection member before the application thereto is directed in the guide.
10. 10. The device according to claim 9, characterized in that the means are composed of securing means that are opened and secured.
11. 11. The device according to any of claims 1-10, characterized in that in a conductive member includes a penetrable membrane, which allows access to the opening (openings) of the main body, so preferably an elastic sealed surface is placed.
12. 12. The device according to any of claims 1-11, characterized in that the clamping means provides the integral elastic pressure portions.
13. 13. The connection unit for use with a device according to any of claims 1-12, characterized in that it includes a connecting member with at least one (second) opening surrounded by a (second) sealed surface, for communicating with an external circuit or a fluid source, and in an unconnected position arranged to be protected by a body of protection which is removable with respect to the connecting member, whereby the connecting member is provided with the fastening means which is adapted to cooperate with the fastening elements in a main body, which forms a guide that opens in both ends, and whereby the protective body carries means to cooperate with the main body such that the connecting member before application thereto is arranged to be directed in the guide.
14. 14. The device according to claim 13, characterized in that the means are composed of securing means that are opened and secured respectively.
15. 15. The device according to claim 13 or 14, characterized in that the protection body is provided with a slidable displacement, which together with the protection body comprise securing means to prevent their replacements after completion of the connection displacement.
16. 16. The protection unit for use with a device according to any of claims 1-12, characterized in that it includes a protection member with protective surfaces and a protective body that is removable with respect to the protection member, whereby the The protection member is provided with the fastening means adapted to cooperate with the fastening elements in a main body, forming a guide that opens at both ends, and whereby the protective body carries the means for cooperating with the main body such that the protection member before the application to it is arranged to be addressed in the guide.
17. 17. The device according to claim 16, characterized in that the means are composed of securing means that are opened and secured respectively.
18. 18. The device according to claim 16 or 17, characterized in that the protection body is provided with a slidable displacement, which together with the protection body comprise securing means to prevent their replacements after completion of the connection displacement. CONNECTION DEVICE FOR MEDICAL PURPOSES SUMMARY OF THE INVENTION A device for external connection of the bloodstream of a patient to an external circuit or a source of fluid for medical purposes, comprising a main body (1) with at least a first opening (8,8 ') surrounded by (a) a first sealing surface (-s) (9,9 ') and adapted to be protected by a removable protection member (24), and a connecting member (10) with at least one second opening (12,12') which is arranged to be protected by a protective body (27) that is removable with respect to the connecting member, wherein the connecting member (10) is connectable to the main body (1) under the removal simultaneously of the protective member (24) and the protection body to obtain the hermetic connection between said openings, where the main body (1) is provided with fastening elements (6) forming a guide (7) which is opened at both ends by the protection member and the connection member respectively. The invention also involves a connection unit for the connection device.