Implantable Skin Piercing Device

Abstract

The skin piercing device is implantable for connecting an external tube to a catheter tube 4 that can be placed in a human or animal body and comprises a cylindrical base body 6 with an upper region 8 and a lower region 10, the base body being provided with a subcutaneous anchor 12, with upper connection means 16 for connecting an external tube and lower connection means 18 for connecting the catheter tube available. The subcutaneous anchor is formed of a number of fixing tabs 14 articulated to the base body, which are pivotable from an insertion position E folded radially downwards to a holding position H folded radially outward. The lower connection means comprises 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 a way that in the inserted lower stop position the adapter piece 20 fixes the fixing tabs in the holding position H folded radially outward.

Description

[Technical field]

[0001] The present invention relates to an implantable skin-piercing device and an apparatus for delivering and / or withdrawing fluids from a patient comprising the same. [Background technology]

[0002] In patients who require repeated or even continuous supply of drugs and / or removal of body fluids, suitable access means, also called "ports", are inserted. Such skin piercing devices comprise a port body with an externally accessible port chamber, which is usually connected to a catheter tube placed inside the body. The port chamber can be accessed in various ways, in particular by piercing. Subcutaneously implantable ports, such as those described in US Pat. No. 5,399,313, are very common. The corresponding port body is located completely under the skin and is sealed in the direction of the skin surface by a piercing membrane or by a specially constructed piercing unit.

[0003] In a percutaneously implantable port, the port chamber is also inserted under the skin, but leaves an entry segment that penetrates the skin and extends outward. Such a percutaneous skin puncture device is described in US Pat. No. 5,399,633. Compared to a subcutaneous device, it has the advantage that it provides safe and reliable access without the need to repeatedly puncture localized skin areas.

[0004] A typical skin lancing device is described in US Pat. No. 5,399,633. [Prior art documents] [Patent documents]

[0005] [Patent Document 1] U.S. Patent No. 5,306,255 [Patent Document 2] European Patent Application Publication No. 0867197 [Patent Document 3] US Patent Application Publication No. 2013 / 072847 Summary of the Invention [Problem to be solved by the invention]

[0006] SUMMARY OF THE PRESENT EMBODIMENT An object of the present invention is to improve skin piercing devices of the above type and to overcome their drawbacks. [Means for solving the problem]

[0007] This object is achieved by a skin piercing device as defined in claim 1 and by a delivery and / or removal device as defined in claim 13. The implantable skin piercing device according to the invention for connecting an external tube to a catheter tube that can be placed inside the human or animal body comprises a substantially cylindrical base body having an upper region facing away from the body in the implanted state and a lower region facing towards the body in the implanted state, the base body being provided in its lower region with a subcutaneous anchor intended for subcutaneous insertion, and having available upper connection means for connecting an external tube and lower connection means for connecting the catheter tube.

[0008] Various advantages result from the fact that the subcutaneous anchor is formed from a plurality of fixing tabs articulated to a base body, the fixing tabs being pivotable from a radially downwardly folded insertion position to a radially outwardly folded holding position, and the lower connection means comprises an adapter piece for a catheter tube, which can be inserted into the base body and which, in the inserted lower stop position, cooperates with the fixing tabs to lock them in the radially outwardly folded holding position.

[0009] Due in particular to the initial narrow shape in the folded-down insertion position, implantation is facilitated, whereby a particularly comparatively small skin incision is sufficient, while a good fixation effect is nevertheless subsequently guaranteed, since the fixing tabs can act optimally in the locked, folded-diametrically-outward holding position. Furthermore, due to the interaction of the adapter piece with the fixing tabs, a particularly simple assembly of the device during the implantation process is achieved.

[0010] Due to its compact assembly and mode of operation as a transdermal device, dead volumes during fluid delivery are significantly reduced compared to conventional subcutaneous devices that require a piercing cup for an external injection needle. The reduction or elimination of dead volumes and associated mixing or dilution effects allows for novel reproduction of time-varying fluid processing using minimal volumes.

[0011] In this context, directional indications should be understood with respect to the implanted state of the device. Thus, "facing away from the body" should be understood in the sense of "facing outwards with respect to the skin surface" and "facing towards the body" should be understood in the sense of "facing inwards with respect to the skin surface". For simplicity, sometimes the term "above" is used equivalently to "facing away from the body" and the term "above" is used equivalently to "facing towards the body", since this corresponds to the graphical representations commonly used in the field. Thus, in a particular placement and orientation of the patient, the "upper region" of the device may actually be facing down, i.e., towards the floor.

[0012] Furthermore, the geometric specifications should not be understood in a strictly mathematical sense, but rather in terms of applicable tolerances as appropriate. It is further understood that the dimensioning, material selection, and material processing are performed according to the intended purpose of implantation in the human or animal body. Regarding the material of the structural components such as the base body and the fixing tabs, specifically titanium, alternatively stainless steel (medical steel), or certain plastics are considered. The dimensions may vary within normal ranges. For example, the diameter of the catheter tube may range from 2 to 5 mm depending on the application.

[0013] Advantageous embodiments are defined in the dependent claims. The main purpose of the fixation tab is to prevent undesired displacement of the implantable skin-piercing device. Advantageously (claim 2), the fixation tab 14 is substantially O-shaped, has rounded edges, and in the insertion position lies within the contour defined by the base body. Due to the central opening, the skin can rapidly grow into the fixation tab and perform the desired function. The embodiment without sharp edges and protruding structures facilitates the insertion of the skin-piercing device through a relatively small skin incision.

[0014] In principle, the adapter piece can be held in its lower stop position in various ways. For this purpose, the base body is preferably provided in its lower region with an internal thread into which a lower threaded ring can be screwed (claim 3). It is particularly advantageous for handling if the lower threaded ring is provided with a number of internal engagement grooves for correspondingly shaped screw fasteners (claim 4).

[0015] In one embodiment (claim 5), the base body is provided in its upper region with a peripheral recess for mounting a support ring, which advantageously allows for mechanical stability during necessary handling, in particular the connection of external tubes, and thus avoids undesirable tensile and compressive forces as well as tilting moments.

[0016] In an advantageous embodiment (claim 6), the upper connection means comprises a tensioning element which can be screwed into the base body and which comprises a cavity formed to receive the septum body in a filling manner, the cavity being defined by a lower bottom surface which comprises at least one passage opening.

[0017] Concerning the upper connection means, it is advantageous if these comprise a connection head, which is connectable to the external tube and which is connectable to the tensioning element (claim 7). For the necessary alignment and fixation, the connection head and the tensioning element are provided with cooperating coupling elements. Preferably (claim 8), the cooperating coupling elements are constructed according to the plug principle, comprising an upper recess in the tensioning element and a corresponding protrusion in the connection head.

[0018] 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 sealed insertion of the catheter tube, at least one transverse channel being formed between the recess and the upper base surface. In the assembled state of the skin piercing device, the base surface is directed upwards facing away from the body and forms a contact surface for screwing the tensioning element therein. Preferably (claim 10), the adapter head is formed in the shape of a dome, 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 cooperates with a correspondingly shaped end area of ​​the fixing tab and pivots the fixing tab radially outwards into a folded holding position. This is therefore a dome-shaped structure directed downwards facing towards the body in the assembled state of the skin piercing device. Furthermore, it is particularly preferred that the recess for the sealed insertion of the catheter tube is arranged laterally of the adapter head (claim 11). In other words, the catheter tube is guided substantially parallel to the skin surface below it.

[0019] According to a particularly preferred embodiment (claim 12), the transverse channel in the adapter head is formed by at least one, preferably three, cannulas, each of which is a lower cannula end (56) configured to protrude from the lateral recess (34); and an adjacent central cannula region (58) configured to be guided in an arc through said adapter head; and An adjacent upper cannula end (60) is configured to protrude from the base surface.

[0020] Each lower end of the cannula, projecting laterally, forms a connection for an associated internal channel of a catheter tube to be attached to the device, and each upper end of the cannula, projecting in a direction pointing away from the body, is intended to reach into an associated septal channel of a septal body attached above it.

[0021] In a basic embodiment, the skin-piercing device includes one fluid channel, although in some applications it may be advantageous to have three internal channels, whereby one channel is each used to supply or withdraw fluid, while a third channel is provided to receive a guidewire.

[0022] According to a further aspect of the invention (claim 13), a device for supplying and / or withdrawing fluids from a patient comprises a skin piercing device according to the invention, a catheter tube connected to the skin piercing device and an external tube connected to the skin piercing device and connectable to a corresponding process unit. The fluid may in particular be a body fluid withdrawn from the patient, i.e. blood, or a supplied active substance solution. Furthermore, depending on the procedure, it may be necessary to convey a rinsing solution through one of the liquid channels, or possibly through both liquid channels, at least at certain times.

[0023] In this context, it is particularly advantageous if the upper connection means comprises a tensioning element which is screwed into the base body, into whose cavity a septum body is inserted in a filling manner, the septum body comprising at least one continuous septum channel, into one of which the upper cannula end of the adapter piece is inserted and into the other of which the lower tube end of the connection head communicating with the external tube is inserted (claim 14).

[0024] Exemplary embodiments of the invention are explained in more detail below with reference to the drawings. [Brief description of the drawings]

[0025] [Figure 1] FIG. 2 is a vertical cross-sectional view of the skin piercing device. [Diagram 2] FIG. 2 is a plan view of the skin puncturing device of FIG. 1. [Diagram 3] 2 is a side cross-sectional view of the skin lancing device of FIG. 1 with a connection head and an external tube attached; [Figure 4] FIG. 4 is a plan view of the skin puncturing device of FIG. 3. [Diagram 5] 2 is a vertical cross-sectional view of the base body of the skin-piercing device of FIG. 1 in an insertion position with the locking tabs folded radially downward. [Figure 6] FIG. 2 is an exploded view of the components of the skin-piercing device. [Figure 7] FIG. 13 is a perspective view of the base body in an insertion position with the fixing tabs folded radially downward. [Figure 8] 8 is a vertical cross-sectional view of the base body of FIG. 7 inserted under the skin and in a holding position with the fixing tabs folded radially outward. [Figure 9] FIG. 9 is a vertical cross-sectional view of the base body of FIG. 8 with a catheter tube protruding therefrom. [Figure 10] FIG. 10 is a side cross-sectional view of the base body of FIG. 9 with an adapter piece attached to a catheter tube. [Figure 11] 11 is a side cross-sectional view of the base body of FIG. 10 with the adapter piece partially inserted into the base body. [Figure 12] FIG. 12 is a perspective view of the base body of FIG. 11 with the adapter piece fully inserted into the base body and the threaded ring screwed into the upper portion thereof. [Figure 13] FIG. 13 is a perspective view of the base body of FIG. 12 with the adapter piece fully inserted into the base body and the tensioning element screwed into its upper portion. [Figure 14] FIG. 1 is a perspective view of an implantable skin piercing device. [Figure 15] 15 is a perspective view of the implantable skin-piercing device of FIG. 14 with a support ring inserted. [Figure 16] FIG. 16 is a perspective view of the implantable skin-piercing device of FIG. 15 with a connection head and external tubing attached. [Figure 17] 17 is a perspective view of the implantable skin-piercing device of FIG. 16 after the support ring has been removed. DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENTS

[0026] 1 to 5 show an implantable skin piercing device for connecting an external tube 2 to a catheter tube 4 that can be placed in a human or animal body. The device comprises a substantially cylindrical base body 6 having an upper region 8 facing away from the body in the implanted state and a lower region 10 facing towards the body in the implanted state. A small skin segment is shown in FIG. 1 to show the installation position relative to the adjacent skin layer S. In its lower region, the base body comprises a subcutaneous anchor 12 intended for subcutaneous insertion, which is formed from a number of fixing tabs 14 articulated to the base body. The fixing tabs are pivotable from an insertion position E, here shown in FIG. 5, folded radially downwards, to a holding position H, here shown in FIGS. 1 to 4, folded radially outwards.

[0027] Furthermore, the skin piercing device comprises upper connection means 16 for connecting an external tube and lower connection means 18 for connecting a catheter tube. The lower connection means comprises an adapter piece 20 for a catheter tube, which can be inserted into the base body and cooperates with the fixing tab in such a way that in the inserted lower stop position shown in Figs. 1 and 3, the adapter piece 20 fixes the fixing tab in a radially outwardly folded holding position H. For this purpose, in the illustrated example, each fixing tab 14 has a cam-shaped end region 24 attached to an associated pivot shaft 22 and facing away from the main segment of the tab. The cam-shaped end region 24 abuts against a correspondingly shaped outer surface region 26 of a dome-shaped adapter head 28. Thus, by lowering the adapter 20, the end region 24 is also lowered and correspondingly the main segment of the fixing tab is raised and locked. As can also be seen in Figs. 1 and 3, the adapter head is provided with a flange-like portion 30 having a base surface 32 and a laterally arranged recess 34 for the sealed insertion of the catheter tube, at least one transverse channel being formed between the recess and the upper base surface.

[0028] In the example shown, the base body 6 is provided in its lower region with an internal thread 38 onto which a lower threaded ring 40 can be screwed in order to hold the adapter piece in its lower stop position.

[0029] The upper connection means comprises a tensioning element 42 which can be screwed into the base body and comprises a cavity formed to receive the septum body 44 in a filling manner, this cavity being defined by a lower bottom surface 46 with at least one passage opening 48. As can be seen in particular from figures 3 and 4, the upper connection means comprises a connection head 50 which is connectable to an external tube and which is connectable at the upper side to the tensioning element, the connection head and the tensioning element being provided with cooperating coupling elements. In the example shown, these are in each case an upper recess 52 and a corresponding protrusion 54 in the tensioning element.

[0030] As shown particularly in FIGS. 1-3, the transverse channel in adapter head 28 is formed by three cannulas, each configured as follows. A lower cannula end 56 projects from the lateral recess 34; The adjacent central cannula region 58 is guided in an arc through the adapter head, An adjacent upper cannula end 60 projects, preferably pointed, from the base surface and leads into a transverse channel 62 in the septum body 44 mounted above it.

[0031] In Figures 3 and 4, the skin piercing device is shown in a ready-to-use state, with the lower tube end 64 of the connection head 50, which communicates with the external tube 2, inserted into the transverse channel 62 of the septum body 44.

[0032] 1 and 3, it is apparent that the septum 44 includes an internal hole 62 which is punctured and dilated by a cannula 64. As shown in FIG. As can be seen from Figures 2 and 4, the fixing tabs are substantially O-shaped and have rounded edges, and the base body is further provided in its upper region with a peripheral recess for mounting the support ring.

[0033] The operating principle and handling of the skin piercing device are further explained in Figures 6 to 17. Features already introduced with the aid of the above figures are given corresponding reference numbers and will only be mentioned again if necessary.

[0034] 6 first shows the important components of the skin piercing device in an exploded view: In addition to the components already described, a clamping ring 68 for the catheter tube is shown. FIG. 7 shows the base body 6 in an insertion position with the fixing tabs 14 folded radially downwards, above a diagrammatically indicated skin area H. It can be seen that in the insertion position the fixing tabs are located within the contour defined by the base body. Thus, a relatively small segment needs to be incised into the skin, which is insufficient with conventional skin piercing devices with rigid subcutaneous anchors. FIG. 8 then shows the situation with the fixing tabs folded radially outward in a holding position.

[0035] In the actual surgical procedure, before the skin piercing device is inserted, the catheter tube 4 is inserted in a manner basically known and inserted into the desired location, for example into a blood vessel. This is usually done by means of a guide wire F. This is shown in FIG. 9, where the clamping ring 68 arranged on the catheter tube can also be seen.

[0036] Figure 10 shows the situation after the adapter piece 20 has been attached to the catheter tube and fixed by clamping the clamping ring 28. The catheter tube 4 is then pulled into the body. This is done in a known manner via a loop guide up to the second skin incision. This results in the situation shown in Figure 11, where the adapter piece has been pulled into the base body.

[0037] Figure 12 then shows the base body of figure 11 with the adapter piece 20 fully inserted and the threaded ring 40 screwed into it above. A screw fastener 70 is also shown, which is inserted with a first end into an engagement groove 72 correspondingly configured for the threaded ring. Furthermore, a retainer 74 is shown, which grips the base body 6 in the peripheral recess 66 already mentioned.

[0038] Figure 13 shows the situation in which the adapter piece 20 is fully inserted into the base body and the tensioning element 42 is screwed into its upper part. For this purpose, a screw fastener 70 is advantageously used again, which at its second end is configured like a ring wrench and thus grips the correspondingly shaped upper edge zone of the clamping element. After removing the screw fastener and the retainer, the situation finally results as shown in figure 14.

[0039] 15 to 17 show the mounting of the connection head 50 which is connected to the external tube 2. First, a specially configured support ring 76 is mounted in the aforementioned peripheral recess 66 of the base body 6. Then, the connection head 50 is attached and finally the support ring 76 is removed again. In this way, the skin piercing device is basically ready for the procedure.

[0040] The skin piercing devices mentioned above as examples can be connected, in a manner known per se, to corresponding process units (not shown) for supplying fluids to and / or withdrawing fluids from a patient.

Claims

1. An implantable skin piercing device for connecting an external tube (2) to a catheter tube (4) that can be placed within a human or animal body, comprising: a substantially cylindrical base body (6) having an upper region (8) facing away from the body in the implanted state and a lower region (10) facing towards the body in the implanted state, said base body being provided in its lower region with a subcutaneous anchor (12) intended for subcutaneous insertion, and having available upper connection means (16) for connecting said external tube and lower connection means (18) for connecting said catheter tube, the subcutaneous anchor is formed from a plurality of fixation tabs (14) articulated to the base body, the fixation tabs being pivotable from a radially downward folded insertion position (E) to a radially outward folded holding position (H); the lower connection means comprises 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 a way that, in an inserted lower stop position, the adapter piece (20) fixes the fixing tabs in the radially outwardly folded holding position (H); A skin puncturing device comprising:

2. the locking tab (14) is substantially O-shaped, has rounded edges, and in the insertion position (E) lies within a contour defined by the base body; The skin piercing device of claim 1 .

3. said base body comprises in its lower region an internal thread (38) onto which a lower threaded ring (40) can be screwed in order to hold said adapter piece in its lower stop position; 3. A skin puncturing device according to claim 1 or 2.

4. The lower threaded ring is provided with a number of internal engagement grooves (72) for correspondingly shaped threaded fasteners (70).

4. The skin piercing device of claim 3.

5. said base body being provided in its upper region with a peripheral recess (66) for mounting a support ring (76) or a retainer (74); A skin puncturing device according to any one of claims 1 to 4.

6. the upper connection means comprises a tensioning element (42) that can be screwed into the base body and comprises a cavity formed to receive the septum body (44) in a filling manner, the cavity being defined by a lower bottom surface (46) having at least one passage opening (48); A skin puncturing device according to any one of claims 1 to 5.

7. The upper connection means further comprises a connection head (50); said connection head (50) being connectable to said external tube and at the top to said tensioning element (42); The connection head and the tensioning element are provided with cooperating coupling elements (52, 54).

7. The skin piercing device of claim 6.

8. the cooperating coupling element includes an upper recess (52) in the tensioning element and a corresponding protrusion (54) in the connection head; 8. The skin piercing device of claim 7.

9. The adapter piece (20) of the lower connection means comprises an adapter head (28); the adapter head (28) having an upper base surface (32) and a recess (34) for sealed insertion of the catheter tube; At least one transverse channel (36) is formed between the recess and the upper base surface. A skin puncturing device according to any one of claims 1 to 8.

10. said adapter head (28) being formed in the shape of a dome such that, when said adapter piece is inserted from above into said base body up to said lower stop position, a surface area (26) of said adapter head cooperates with a correspondingly shaped end area (24) of said fixing tabs to pivot said fixing tabs radially outwardly into said folded retaining position, 10. The skin-piercing device of claim 9.

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

12. The transverse channel in the adapter head (28) is formed by at least one, preferably three, cannulas, each of which: a lower cannula end (56) configured to protrude from said lateral recess (34); and an adjacent central cannula region (58) configured to be guided in an arc through said adapter head; and an adjacent upper cannula end (60) configured to protrude from said base surface; 12. The skin-piercing device of claim 11.

13. A skin puncture device according to any one of claims 1 to 12, A catheter tube (4) connected to the skin puncture device; an external tube (2) connected to the skin puncturing device and connectable to a corresponding process unit; Equipped with An apparatus for delivering and / or withdrawing fluid from a patient.

14. the upper connection means comprises a tensioning element (42) which is screwed into the base body, A septum body (44) is inserted into the cavity of the base body in a filling manner; the septal body comprises at least one continuous septal channel (62); The upper cannula end (60) of the adapter piece is inserted into one of the septum channels (62), and the lower tube end (64) of the connection head (50) communicating with the external tube (2) is inserted into the other of the septum channels (62).

14. The apparatus of claim 13.

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