IMPLANTABLE SKIN PASSAGE DEVICE

Description

Technical area

[0001] The invention relates to an implantable skin perforation device and a device equipped therewith for supplying and / or removing fluid from a patient. State of the art

[0002] Patients requiring repeated or even continuous administration of medication and / or removal of bodily fluids are fitted with appropriate access devices, also known as "ports." These skin-permeable devices consist of a port body with an externally accessible port chamber, which is typically connected to an internal catheter tube. Access to the port chamber can be achieved in various ways, most notably by puncture. Subcutaneously implanted ports, such as those described in US 5306255 A, are very common. In this case, the port body lies entirely beneath the skin and is sealed off from the skin surface by a perforated membrane or a specially configured puncture device.

[0003] In percutaneously implanted ports, the port chamber is also placed under the skin, but an entry segment remains that extends through the skin to the outside. Such a percutaneous skin penetration device is described in EP 0867197 A2. Compared to subcutaneous devices, this offers the advantage of safe and reliable access without the need for repeated insertion into a locally confined skin area.

[0004] A generic skin penetration device is described in US 2013 / 072847 A1. Description of the invention

[0005] The object of the invention is to improve a generic skin penetration device and to overcome its disadvantages.

[0006] These tasks are solved by the skin penetration device defined in claim 1 and by the supply and / or withdrawal device defined in claim 13.

[0007] The implantable skin penetration device according to the invention for connecting an external tube with a catheter tube that can be placed inside the human or animal body comprises a substantially cylindrical base body with an upper region facing away from the body in the implanted state and a lower region facing the body in the implanted state, wherein the base body is equipped in its lower region with a subcutaneous anchoring provided for subcutaneous insertion, and wherein upper connection means for connecting the external tube and lower connection means for connecting the catheter tube are provided.

[0008] Several advantages arise from the fact that the subcutaneous anchoring is formed from a plurality of fixing tabs articulated to the base body, whereby the fixing tabs can be pivoted from a radially downward folded insertion position to a radially outward unfolded holding position, and that the lower connecting means have an adapter piece for the catheter tube that can be inserted into the base body and that interacts with the fixing tabs in such a way that, in an inserted lower stop position, it locks the fixing tabs in the radially outward unfolded holding position.

[0009] In particular, the initially slim design, when folded into the insertion position, facilitates implantation, requiring a comparatively smaller skin incision. Nevertheless, excellent fixation is subsequently ensured because the fixation tabs function optimally in the locked, radially extended holding position. Furthermore, the interaction of the adapter and fixation tabs allows for particularly easy assembly of the device during the implantation procedure.

[0010] Due to its compact design and its function as a percutaneous device, dead volumes during fluid delivery are drastically reduced compared to conventional subcutaneous devices that require a piercing cup for an external injection needle. The reduction or elimination of dead volumes and the associated mixing and dilution effects makes it possible to simulate time-varying fluidic processes with minute volumes in a novel way.

[0011] In this context, directional terms refer to the implanted position of the device. "Away from the body" means "pointing outwards relative to the skin surface," and "towards the body" means "pointing inwards relative to the skin surface." For simplicity, the terms "above" and "below" are sometimes used interchangeably, as they correspond to the commonly used graphic representations in this field. Thus, in certain implant positions and patient orientations, an "upper area" of the device could indeed point downwards, i.e., towards the floor.

[0012] Furthermore, geometric specifications should not be understood in a strictly mathematical sense, but rather in view of the tolerances that can be applied as appropriate.

[0013] Furthermore, it goes without saying that the dimensions, material selection, and processing are carried out according to the intended purpose of implantation in the human or animal body. Titanium is the primary material used for structural components such as the base and fixation tabs; alternatively, stainless steel (medical-grade steel) or certain plastics are also suitable. The dimensions can vary within the usual range. For example, the diameter of the catheter tube will range from 2 to 5 mm, depending on the application.

[0014] Advantageous embodiments are defined in the dependent claims.

[0015] The primary function of the fixation tabs is to prevent unwanted displacement of the implanted skin graft. Advantageously (claim 2), the fixation tabs are essentially O-shaped with rounded edges and, in their inserted position, lie within an outline defined by the base body. The central opening allows skin to quickly grow into the fixation tab, thereby achieving the desired function. The design, without sharp edges or protruding structures, facilitates the insertion of the skin graft through a comparatively small skin incision.

[0016] In principle, the adapter piece can be held in its lower stop position in various ways. Preferably (claim 3), the base body is provided with an internal thread in its lower region into which a lower threaded ring can be screwed. It is particularly advantageous for handling if the lower threaded ring is equipped with a number of internal engagement grooves for a suitably designed screwing or holding tool (claim 4).

[0017] In one embodiment (claim 5), the base body is equipped in its upper region with marginal recesses for attaching a support ring. This advantageously allows for mechanical stabilization during necessary handling operations, such as, in particular, connecting the external hose. Undesirable tensile and shear forces, as well as tilting moments, are thus avoided.

[0018] In an advantageous embodiment (claim 6), the upper connecting means comprise a clamping element that can be screwed into the base body and which has a cavity designed to receive a septum body and which is bounded by a lower bottom surface, the latter having at least one through-opening.

[0019] With regard to the upper connection means, it is advantageous (claim 7) if these comprise a connection head that can be connected to the external hose and which can be connected to the clamping element from above. For the necessary alignment and fixation, the connection head and clamping element are equipped with cooperating coupling elements. Preferably (claim 8), the cooperating coupling elements, according to a plug principle, comprise an upper recess in the clamping element and a corresponding projection in the connection head.

[0020] According to an advantageous embodiment (claim 9), the adapter piece of the lower connection means comprises an adapter head with a base surface and a recess for the sealing insertion of the catheter tube, wherein at least one passage channel is formed between the recess and the upper base surface. In the assembled state of the skin penetration device, the base surface is oriented towards the upper side facing away from the body and forms a contact surface for a clamping element screwed onto it. Preferably (claim 10), the adapter head is dome-shaped such that, when the adapter piece is inserted into the base body up to the lower stop position, a surface area of ​​the adapter head interacts with correspondingly shaped end areas of the fixing tabs and pivots them into the radially unfolded holding position.This is therefore a dome-shaped structure which, in the assembled state of the skin penetration device, faces the lower, body-facing side. It is particularly preferred (claim 11) that the recess for the sealing insertion of the catheter tube is arranged laterally on the adapter head. In other words, the catheter tube is guided away essentially parallel to the skin surface, beneath it.

[0021] According to a particularly preferred embodiment (claim 12), the through-channel in the adapter head is formed by at least one, preferably three, cannula(s), each cannula being configured as follows: A lower cannula end protrudes from the lateral recess, a subsequent central cannula section is guided in an arc through the adapter head, and a subsequent upper cannula end protrudes from the base. Each laterally protruding lower cannula end forms a connection for a corresponding internal channel of a catheter tube to be attached to the device.

[0022] Each upper end of the cannula projecting in a direction away from the body is designed to reach into a corresponding septal canal of a septum body placed above it.

[0023] In its basic form, the skin penetration device comprises a single fluid channel. For some applications, it is advantageous to have three internal channels, one for the supply and one for the drainage of fluid, while a third channel is provided for a guide wire.

[0024] According to a further aspect of the invention (claim 13), a device for supplying and / or withdrawing fluid from a patient comprises a skin perforation device according to the invention, a catheter tube connected thereto, and an external tube connected thereto, which can be connected to a corresponding processing unit. The fluid may, in particular, be withdrawn body fluid, namely patient blood, or an administered drug solution. Furthermore, depending on the procedure, it may be necessary, at least at certain times, to deliver a rinsing solution through one of the fluid channels or possibly even through both fluid channels.

[0025] It is particularly advantageous (claim 14) if the upper connecting means comprise a clamping element screwed into the base body, in the cavity of which a septum body is inserted to fill the space, wherein the septum body has at least one continuous septum channel into which, on the one hand, an upper cannula end of the adapter piece and, on the other hand, a lower tube end of the connecting head communicating with the external hose are inserted. Short description of the drawings

[0026] Exemplary embodiments of the invention are described in more detail below with reference to the drawings, which show: Fig. 1 a skin penetration device, in a vertical sectional view; Fig. 2 the skin penetration device of the Fig. 1 , in top view; Fig. 3 the skin penetration device of the Fig. 1 with attached connection head and external hose, in a vertical sectional view; Fig. 4 the skin penetration device of the Fig. 3, in top view; Fig. 5 Components of a skin penetration device, in an exploded view; Fig. 6 A base body with fixing tabs in radially folded insertion position, in a perspective view; Fig. 7 The base body of the Fig. 6 , placed under the skin and secured with fixation tabs in a radially unfolded holding position, in a vertical sectional view; Fig. 8 the basic body of the Fig. 7 , with protruding catheter tube, in a vertical sectional view; Fig. 9 the basic body of the Fig. 8 , with adapter attached to the catheter tube, in a vertical sectional view; Fig. 10 the basic body of the Fig. 9 , with adapter piece partially inserted into the base body, in a vertical sectional view; Fig. 11 the base body of the Fig. 10 , with the adapter piece fully inserted into the base body and the threaded ring screwed onto it, in a perspective view; Fig. 12 the base body of the Fig. 11 , with the adapter piece fully inserted into the base body and the clamping element screwed onto it, in a perspective view; Fig. 13 an implanted skin perforation device, in a perspective view; Fig. 14 the implanted skin perforation device of the Fig. 13 , with attached support ring, in a perspective view; Fig. 15 the implanted skin perforation device of the Fig. 14 , with attached connection head and external hose, in a perspective view; and Fig. 16 the implanted skin perforation device of the Fig. 15 , after removal of the support ring, in a perspective view. Ways to implement the invention

[0027] The Fig. 1 to 4Figure 1 shows an implantable skin penetration device for connecting an external tube 2 to a catheter tube 4 that can be placed inside the human or animal body. The device comprises a substantially cylindrical base body 6, with an upper region 8 facing away from the body when implanted and a lower region 10 facing the body when implanted. To illustrate the insertion position in relation to the adjacent skin layer S, a small skin segment is shown in the Fig. 1 The base body is equipped in its lower region with a subcutaneous anchor 12 intended for subcutaneous insertion, which is formed from a plurality of fixing tabs 14 hinged to the base body. The fixing tabs can be pivoted from a radially folded insertion position E (not shown here) to the radially unfolded holding position H shown here.

[0028] Furthermore, the skin penetration device is equipped with upper connection means 16 for connecting the external tube and with lower connection means 18 for connecting the catheter tube.

[0029] The lower connection elements have an adapter piece 20 for the catheter tube that can be inserted into the base body and interacts with the fixing tabs in such a way that it is in the Fig. 1 and 3In the lower stop position shown, the fixing tabs are fixed in the radially unfolded holding position H. For this purpose, in the example shown, each fixing tab 14 is mounted on an associated pivot axis 22 and has a cam-like end section 24 facing away from the main segment of the tab. The latter rests against a correspondingly shaped outer surface area 26 of a dome-shaped adapter head 28. Thus, by lowering the adapter 20, the end section 24 is also lowered, and the main segment of the fixing tab is correspondingly raised and locked. As can also be seen from the Fig. 1 and 3 As can be seen, the adapter head has a flange-like section 30 with a base surface 32 and a laterally arranged recess 34 for sealing insertion of the catheter tube, wherein at least one passage channel 36 is formed between the recess and the upper base surface.

[0030] In the example shown, the base body 6 is equipped in the lower area with an internal thread 38 into which a lower threaded ring 40 can be screwed in to hold the adapter piece 20 in its lower stop position.

[0031] The upper connecting means comprise a clamping element 42 that can be screwed into the base body and which has a cavity designed to accommodate a septum body 44, bounded by a lower bottom surface 46 with at least one through-opening 48. As can be seen in particular from the Figs. 3 and 4 As can be seen, the upper connection means comprise a connection head 50 that can be connected to the external hose and which can be connected to the clamping element from above, wherein the connection head and the clamping element are equipped with cooperating coupling elements. In the example shown, these are an upper recess 52 in the clamping element and an associated projection 54.

[0032] As particularly in the Fig. 1 to 3 As shown, the through-channel in the adapter head 28 is formed by three cannulas, each cannula being configured as follows: A lower cannula end 56 protrudes from the lateral recess 34, a subsequent central cannula section 58 is guided in an arc through the adapter head, and a subsequent upper cannula end 60 protrudes from the base surface and is preferably provided with a tip. This upper cannula end leads into a passage 62 of the overlying septal body 44.

[0033] In the Figs. 3 and 4 The skin penetration device is shown in its ready-to-use state, with a lower tube end 64 of the connection head 50 communicating with the external tube 2 being inserted into the passage channel 62 of the septum body 44.

[0034] From a synthesis of Fig. 1 and 3It is evident that the septum 44 has an internal bore 62, which is pierced by the cannula 64 and thus spread open.

[0035] As from the Fig. 2 and 4 As can be seen, the fixing tabs are essentially O-shaped and have rounded edges. Furthermore, the base body is equipped in its upper area with marginal recesses 66 for attaching a support ring.

[0036] The function and use of the skin penetration device are described in the Figs. 5 to 16 further explained. Features already introduced with the figures above are marked with corresponding reference symbols and are only mentioned again where necessary.

[0037] The Fig. 5 Figure 1 shows important components of a skin penetration device in an exploded view. In addition to the components already discussed, a clamping ring 68 for the catheter tube is shown.

[0038] The Fig. 6 Figure 1 shows a base body 6 with fixing tabs 14 in a radially folded insertion position, above a schematically represented skin area H. It is evident that the fixing tabs, in their insertion position, are located within an outline defined by the base body. Accordingly, a comparatively small segment of skin needs to be incised, which would not be sufficient with a conventional skin penetration device with rigid subcutaneous anchoring. Fig. 7 The situation with fixing tabs in the radially unfolded holding position is then evident.

[0039] In practical surgical procedures, before inserting the skin penetration device, the catheter tube 4 is inserted in a generally known manner and guided to the desired location, for example, into a blood vessel. This is usually done with the aid of a guide wire F. This is in the Fig. 8illustrates where the clamping ring 68, which is placed on the catheter tube, is also visible.

[0040] The Fig. 9 Figure 1 shows the situation after an adapter piece 20 was attached to the catheter tube and secured by clamping the clamping ring 28. Subsequently, the catheter tube 4 was drawn into the body, which is done in a known manner via a loop guide to a second skin incision. This results in the following: Fig. 10 The situation shown is one in which the adapter piece is inserted into the base body.

[0041] The Fig. 11 then shows the basic shape of the Fig. 10with the adapter piece 20 fully inserted and the threaded ring 40 screwed onto it. Also shown is a screwing tool 70, the first end of which is inserted into correspondingly configured engagement grooves 72 of the threaded ring. In addition, a holding tool 74 is shown, which grips the base body 6 at the aforementioned edge recesses 66.

[0042] The Fig. 12 Figure 1 shows the situation with the adapter piece 20 fully inserted into the base body and the clamping element 42 screwed onto it. Advantageously, the screw tool 70 is again used for this purpose, which is configured like a ring wrench at its second end and thus engages a correspondingly shaped upper edge zone of the clamping element. After removing the screw tool and the holding tool, the following result is obtained: Fig. 13 depicted situation.

[0043] In the Figs. 14 to 16The attachment of the connection head 50, which is connected to the external hose 2, is also shown. First, a specifically configured support ring 76 is attached to the previously mentioned marginal recesses 66 of the base body 6. Then, the connection head 50 is placed on top, and finally, the support ring 76 is removed. The skin penetration device is now basically ready for operation.

[0044] The skin perforation device described above as an example can be connected to a corresponding process unit (not shown here) for the supply and / or removal of fluid from a patient in a generally known manner.

Claims

1. An implantable skin piercing device for connecting an external tube (2) to a catheter tube (4) that can be placed inside the human or animal body, comprising: a substantially cylindrical base body (6) with an upper region (8) facing away from the body in the implanted state and a lower region (10) facing the body in the implanted state, wherein the base body is provided in its lower region with a subcutaneous anchorage (12) intended for subcutaneous insertion and wherein upper connection means (16) for connecting the external tube and lower connection means (18) for connecting the catheter tube are available, characterized in that the subcutaneous anchorage is formed from a plurality of fixing tabs (14) articulated on the base body, and wherein the fixing tabs are pivotable from a radially downwards folded insertion position (E) into a radially outwards folded holding position (H), and the lower connection means comprise an adapter piece (20) for the catheter tube which can be inserted into the base body and which cooperates with the fixing tabs in such manner that in an inserted lower stop position, it fixes the fixing tabs in the radially outwards folded holding position (H).

2. The skin piercing device according to claim 1, wherein the fixing tabs (14) are formed substantially O-shaped and with rounded edges and, in their insertion position (E), lie within an outline defined by the base body.

3. The skin piercing device according to claim 1 or 2, wherein the base body is provided in the lower region thereof with an internal thread (38), into which a lower threaded ring (40) can be screwed in order to hold the adapter piece in its lower stop position.

4. The skin piercing device according to claim 3, wherein the lower threaded ring is provided with a plurality of internal engagement grooves (72) for a correspondingly shaped screwing tool (70).

5. The skin piercing device according to one of claims 1 to 4, wherein the base body is provided in its upper region with peripheral depressions (66) for attaching a support ring (76) or holding tool (74).

6. The skin piercing device according to one of claims 1 to 5, wherein the upper connection means comprise a tensioning element (42) which can be screwed into the base body and which comprises a cavity formed to receive a septum body (44) in a filling manner, which cavity is delimited by a lower bottom surface (46) with at least one passage opening (48).

7. The skin piercing device according to claim 6, wherein the upper connection means further comprises a connection head (50) which is connectable to the external tube and which is connectable to the tensioning element (42) on the upper side, wherein the connection head and the tensioning element are provided with cooperating coupling elements (52, 54).

8. The skin piercing device according to claim 7, wherein the cooperating coupling elements comprise an upper recess (52) in the tensioning element and a corresponding projection (54) in the connecting head.

9. The skin piercing device according to one of claims 1 to 8, wherein the adapter piece (20) of the lower connection means comprises an adapter head (28) with a base surface (32) and a recess (34) for a sealing insertion of the catheter tube, wherein at least one traversing channel (36) is formed between the recess and the upper base surface.

10. The skin piercing device according to claim 9, wherein the adapter head (28) is formed in the shape of a dome in such manner that when the adapter piece is inserted into the base body up to the lower stop position, a surface region (26) of the adapter head cooperates with correspondingly shaped end regions (24) of the fixing tabs and pivots these into the radially outwards folded holding position.

11. The skin piercing device according to claim 10, wherein the recess (34) for the sealing insertion of the catheter tube (4) is arranged laterally on the adapter head (28).

12. The skin piercing device according to claim 11, wherein the traversing channel in the adapter head (28) is formed by at least one, preferably three, cannula(s), wherein each cannula is configured as follows: - a lower cannula end (56) protrudes from the lateral recess (34), - an adjoining central cannula region (58) is guided in an arc-shaped manner through the adapter head, - an adjoining upper cannula end (60) protrudes from the base surface.

13. A device for supplying and / or withdrawing fluid from a patient, comprising: a skin piercing device according to one of the preceding claims, a catheter tube (4) connected thereto and an external tube (2) connected thereto, which can be connected to a corresponding process unit.

14. The device according to claim 13, wherein the upper connection means comprise a tensioning element (42) which is screwed into the base body, in the cavity of which a septum body (44) is inserted in a filling manner, wherein the septum body comprises at least one continuous septum channel (62), into which, on the one hand, an upper cannula end (60) of the adapter piece and, on the other hand, a lower tube end (64) of the connection head (50) communicating with the external tube (2) are inserted.