WO2008014849A1

WO2008014849A1 - Medical device

Info

Publication number: WO2008014849A1
Application number: PCT/EP2007/005499
Authority: WO
Inventors: Peter Osypka
Original assignee: Peter Osypka
Priority date: 2006-07-29
Filing date: 2007-06-22
Publication date: 2008-02-07
Also published as: EP2046205A1; DE102006035191B4; DE102006035191A1

Abstract

A medical device (1), such as a biopsy cannula, or an ASD lock, or such, has at least one part (2) consisting of steel, iron, or weldable metal, and one part (3), connected to the same in a use position, consisting of nitinol, wherein nitinol is not weldable. The connection site (4) of the steel part (2) and/or of the nitinol part (3) is constructed in a tube, or sleeve shape, or as a port, or a protrusion, particularly a protrusion made of solid material, or a hollow protrusion, and at least one connecting sleeve (5) is provided, which grasps and/or overlaps the connection site (4), and thereby also both the steel part (2) and the nitinol part (3). The connecting sleeve (5) can be connected to the steel part (2) in a form-fitting manner, by means of screwing, and/or by means of welding, and/or riveting, or connected to the nitinol part (3) as one piece in a mechanically overlapping, and/or in a form-fitting manner. The steel part (2) and the nitinol part (3) themselves can be connected to each other in a form-fitting manner. The reciprocal connection, however, can also occur additionally, or exclusively, via the connecting sleeve (5).

Description

Medical device

The invention relates to a medical device such as Biop- er cannula or ASD closure with at least one made of steel or iron and connected thereto in the position of use, consisting of Nitinol part.

In various fields and applications of medicine and surgery, it is expedient or necessary to use a part made of steel, for example a tube of a biopsy cannula or device with a Nitinolteil, for example, an easily bendable end of such Biop- er cannula or The same or an existing Nitinol ASD closure with a Zuführkatheder steel or iron or a corresponding alloy, although steel or iron and nitinol can not be welded together.

Therefore, elaborate embossing connections have been carried out on various occasions or a corresponding design of the medical device on the one hand made of inexpensive steel and on the other hand the well-flexible Nitinol tip is dispensed with.

It is therefore the object to provide a medical device, such as a biopsy cannula or an ASD closure of the type mentioned above, wherein between a steel or iron and a nitinol existing part of a permanent tensile connection is possible. To solve this seemingly contradictory task is provided that the connection point of the steel part and / or the Nitinolteiles tube or tube-shaped or is formed as a neck or as a projection of solid material and that a connecting sleeve is provided which detects both the steel part and the nitro part and / or overlaps that the connecting sleeve with the steel part is positively and / or positively connected by welding or in one piece and with the Nitmolteil cross-mechanically.

In this way, the difficulty can be overcome that steel and nitmol can not be welded, which is usually the simplest type of mutual permanent tensile bond. The steel part can be connected to the sleeve either in one piece or by welding or also by positive engagement, while this sleeve can be mechanically and / or positively connected to the nitmol part, which does not permit welding.

It is particularly useful in this case if the steel part and the Nitmolteil themselves are positively connected to each other. This is especially true for a biopsy cannula, in which a steel tube and a piece of nitro-nylitol should be connected to each other practically flush.

The steel part and the nitro moiety can thus be designed as continuous tube pieces, for example for forming a cannula, and touch each other at their front ends, and the one part can have at least one recess forming a hermetic intersection and the other part can fit into this recess, have axially projecting projection. Thus, the two tubular or sleeve-like parts can fit together in the axial direction and thereby be permanently connected by the overlapping sleeve.

At the contacting end faces on the one hand of the tubular or tube-shaped steel part and on the other hand of the tubular or tubular Nitinolteils, in particular a needle tip made of Nitinol, at least two recesses with undercuts and engaging in these projections can be provided on the circumference, preferably both Recesses may be arranged on the Nitinolteil, but also a recess on the one and the other recess could be provided on the other part. Due to the undercut of the roughly tab-shaped projection on the recess, a positive connection is produced not only in the direction of rotation, but also in the axial direction, that is to say under tensile load, with the overlapping sleeve preventing the corresponding projections from being deflected or bent out of the recesses ,

It is expedient if at least one overlapping connecting sleeve is arranged on the outside on one of the parts to be connected or on the outside on both parts to be joined. Thus, the junction is protected by this overlapping connection sleeve against external mechanical effects, so that the risk that a projection is deflected from a recess, is almost impossible.

It is particularly expedient if the steel part and the Nitinolteil in the connection region and the connecting sleeve have a circular cross-section. Such a cross section is particularly easy to handle and requires no special orientation in the direction of rotation for the overlapping sleeve. This could possibly be appropriate and necessary if at the same time in the connection area Rotational security for this overlapping sleeve would be provided relative to the parts to be joined.

The connection sleeve can at least in some areas have touch contact and / or a sliding or clamping seat with at least one of the parts to be connected or with both parts in the position of use. Accordingly, it can be arranged on the outside or on the inside of the parts to be joined and welded to the steel part, for example.

A particularly favorable definition of the overlapping connection sleeve in the connection region in the axial and in the rotational direction can provide that the overlapping connection sleeve and the Nitinolteil in the common overlap region in each case least one transversely or perpendicular to the sleeve center or sleeve axis arranged, extending through both parts at least partially or continuing opening or perforation or bore, in which a sleeve engages the Nitinolteil at least over a portion of the extension of the openings or holes or holes passing projection or pin or rivet, which produces positive connection with the connecting sleeve. In this way, therefore, the connection point can make a positive connection with the nitinol part via the connection sleeve, so that projections engaging in a recess in the axial direction can be assisted or even possibly avoided. Such an arrangement is also particularly useful in the connection of an ASD closure with a steel sleeve part to which a Einführkatheder example, can be screwed axially.

The opening or perforation or bore in the overlap region and the projection or pin or rivet engaging therein can expediently extend radially to the connection sleeve. Accordingly easy is the attachment of both the hole and the pin.

Also or only the overlapping part of the connecting sleeve and the steel part can be positively connected in the axial direction and in the rotational direction by means of at least one projection or pin or rivet passing through both parts. In addition to or instead of a welding of the connecting sleeve with the steel part, therefore, a mechanical connection with the aid of a transverse pin or the like can also take place in order to be able to transmit higher forces.

The overlapping sleeve may be provided on the outside and / or inside of the steel part and on the nitinol part, and the projection or pins or rivets may pass through the steel part or the nitinol part and all connection sleeves at least over part of the wall thickness.

A sleeve overlapping on the outside has a larger cross-section in the overlapping area than the part encompassed by it. At the same time it could overlap the other parts on the inside, if this in turn would have a larger cross-section. As a rule, however, both parts to be joined will have matching cross sections, so that the overlapping sleeve either engages on the outside over both parts or engages on the inside in both parts. Finally, however, a sleeve on the outside and a second sleeve on the inside in the connection region, these overlapping, could be provided in order to reinforce the mutual connection even better.

The regions of the steel part and the nitinol part which can be connected by means of a connecting sleeve arranged on the outside can be radially inwards relative to areas adjacent thereto deformed or contracted and the connection sleeve can fill the extent of this collection completely or at least partially. Thus, in a preferred embodiment, the outside of the connection sleeve may have the same external cross section as the steel part and / or the nitinol part adjacent to the joint and its neck.

It should be noted that at least one of the connecting sleeves can be made of steel, so that their welding to the steel part is particularly simple. In addition, such a steel sleeve has a high strength, so that the rivet connection with the Nitinolteil is correspondingly stable. Furthermore, such a sleeve supports the axially engaging in a recess projections in the radial direction outwardly and / or inwardly against deformation, so that a total of high-strength connection between the two parts of steel on the one hand and Nitinol on the other can be formed, although these both parts can not be welded. Hereinafter, embodiments of the invention are described in more detail with reference to the drawing. It shows in partly schematized representation:

Fig. 1 A partially longitudinally held medical device, namely a cannula, in particular a biopsy cannula, the tip of which consists of Nitinol and with a tube made of steel or iron or weldable

Metal is mechanically and positively connected at the joint joint, wherein the joint is overlapped on the outside by a connecting sleeve, which is welded to the tube,

Fig. 2 is a representation corresponding to Fig. 1 a modified embodiment in which the connecting sleeve in addition to the steel or metal tube riveted, wherein in addition an inner overlapping or supporting sleeve is provided for the connection area,

3 shows a modified embodiment corresponding to FIGS. 1 and 2, in which the cannula tip and the tubular part butt together and the overlapping sleeve is also connected to the nitinol part by rivets, wherein an outer sleeve is provided for mutual connection, which is not only welded to the steel part, but additionally riveted,

4, a further embodiment analogous to FIG. 2, wherein the cannula tip and the tubular metal or steel part are butt joined together and both parts are riveted to an outer and an inner connecting sleeve,

FIG. 5 shows an embodiment corresponding to FIG. 4, in which the connection region is deformed or drawn in radially inward so that the outer connection sleeve approximately corresponds in its outer diameter or outer cross section to that of the nitinol tip and the metal or steel part, as well as FIG

6 shows a medical device as an ASD closure or occlusion device analogous to DE 103 38 702 B3, wherein a socket of this closure made of nitinol is connected to a sleeve-shaped steel part with a coaxial internal thread by riveting. In the following description of various embodiments, parts which correspond in their function receive matching reference numbers even in the case of an applied design.

A medical device, denoted overall by 1, can be a biopsy cannula according to FIGS. 1 to 5 and, according to FIG. 6, an ASD closure analogous to the occlusion device according to DE 103 38 702 B3. In all these devices 1 each one consisting of steel or iron or other weldable metal part 2, hereinafter also referred to as "steel part", and at least one of Nitinol existing part 3, hereinafter referred to as "Nitinolteil 3", said this Parts 2 and 3 are in the position of use, as shown in the embodiments, connected to each other, although Nitinol is not weldable, so it can not be easily welded to the "steel part" or Part 2.

It can be seen in all figures that the connection point 4 of the steel part 2 and the Nitinolteils 3, tube or tube-shaped or as a nozzle or projection, also of solid material (Fig. 6) is formed. At the connection point 4, at least one connecting sleeve 5 is provided, which covers or overlaps both the steel part 2 and the nitinol part 3. In this case, the connecting sleeve 5 with the steel part 2 form fit, by screwing, by welding (Fig. 1 to 5) and / or by riveting (Fig. 2 to 5) or in one piece (Fig. 6) and in a manner to be described with the Nitinolteil 3 across, be mechanically and / or positively connected.

In Figs. 1 and 2 it is shown that the steel part 2 and the Nitinolteil 3 itself positively connected to each other may be, so that the connection sleeve 5, the Nitinolteil 3 and the junction 4 only needs to overlap to produce a stable connection. The steel part 2 and the Nitinolteil 3 are formed as a continuation of pipe sections, for example, to form a cannula or biopsy cannula. These pieces of pipe contact each other at their front ends and the one part, in the embodiment, the Nitinolteil 3, has at least one recess forming an undercut 6 and the other part, so the steel part 2 has a matching in this recess 6, axially projecting projection 7, of the recess 6 positively filling and produces positive engagement and tensile strength due to the undercuts 8 not only in the direction of rotation, but also in the axial direction.

In this case, according to FIGS. 1 and 2, on the contacting end faces on the one hand of the tubular or tubular steel part 2 and on the other hand of the tubular or tubular Nitinolteils 3 on the circumference two recesses 6 with undercuts 8 and engaging in these projections 7 may be provided, both recesses 6 are arranged on the Nitinolteil 3, but also a reverse arrangement could be selected.

The already mentioned connection sleeve 5 overlaps this mutual connection and is fastened to the steel part 2 on one of the parts to be joined, in the exemplary embodiments according to FIGS. 1 and 2, and overlaps the connection point 4, so that the projection 7 is not radially deflected or moved bent outside and thereby can be moved out of the recess 6. Furthermore, thereby the projection 7 is protected against unwanted loading from the outside. Conveniently, in all embodiments, the steel part 2 and the Nitinolteil 3 at least in the connection region 4 as well as the connecting sleeve 5 has a circular cross-section. In this case, the connecting sleeve 5 with the parts to be connected in contact position in use contact and is suitably arranged in a sliding or clamping seat and additionally mechanically fastened in a manner to be described. Correspondingly well, the connection point 4 is protected and reinforced.

While in Fig. 1, the connecting sleeve 5 is only connected or welded to the steel part 2 by means of a weld 9 and according to FIG. 2 with them and the steel part 2 radially passing pins or rivets 10 is additionally connected, while the Nitinolteil 3 via the recess. 6 and the projection 7 is fixed thereto, it is provided in the embodiments according to FIGS. 3 to 6, that the overlapping connection sleeve 5 and the Nitinolteil 3 in the common overlap region in each case at least one or more circumferentially distributed, transversely or perpendicularly to the sleeve center or sleeve axis arranged, continuing openings or perforations or holes, in each of which the sleeve 5 and the Nitinolteil 3 by passing projection or pin or rivet 10 engages, which then produces between Nitinolteil 3 and connection sleeve 5 positive locking in the direction of rotation and especially in the axial direction, so that tensile strength is given.

FIG. 3 shows an arrangement in which the connecting sleeve 5 is both welded to the steel part 2 and connected via such rivets 10 and additionally riveted in accordance with the Nitinol part 3. If necessary, it would be possible for the pins or rivets 10 to be located in the region of the steel part 2. Because of the weld 9 also be waived. Conversely, with regard to the riveting with the steel part 2 could possibly be dispensed with the weld 9.

It can be seen in all embodiments, that the openings or holes or holes in the overlap region and the engaging projection or pin or rivet 10 extend radially to the connecting sleeve 5, resulting in the simplest production.

Thus, while in the embodiment of FIG. 1, the steel part 2 and the Nitinolteil 3 itself positively connected by means of the recess 6 and the projection 7 engaging therein and the connection point 4 is overlapped by the sleeve 4, which welded to the steel part 2 and / or by means Pins or rivets 10 may be connected in the embodiment of FIGS. 3 to 6 by the overlapping sleeve 5 and the Nitinolteil 3 by means of pins or rivets 10, while the sleeve 5 also connected to the steel part 2 in the ways already described can be.

According to Fig. 2 to 6, namely, the overlapping part of the connecting sleeve 5 and the steel part 2 by at least one both parts passing through projection or pin or rivet 10 in the axial direction thereby be positively connected, that this pin or rivet 10 also transverse or radially in appropriate openings is inserted.

The overlapping sleeve 5 can, as shown in all Ausführungsbei- play, be provided on the outside of the steel part 2 and the Nitinolteil 3, but can also be provided on the inside or both outside and inside, according to Figures 2, 4 and 5, so that in this According to FIGS. 2, 4 and 5 two overlapping sleeves 5 are provided. The projections or pins or rivets 10 then pass through all connecting or overlapping sleeves 5 and of course also the parts 2 or 3 located therebetween.

In Fig. 5, an embodiment is shown, in which the means of an externally arranged connecting sleeve 5 directly or indirectly connectable areas of the steel part 2 and the matching in cross-section with the steel part 2 Nitinolteils 3 opposite thereto adjacent areas deformed radially inwardly or contracted, wherein the connection sleeve 5 at least partially fills the extent of this collection or the outside of this connection sleeve 5 in this embodiment has the same outer cross section as the steel part 2 and the Nitinolteil 3 adjacent to the connection point 4 and the retracted area. Despite the externally arranged connection sleeve 5, the medical device 1 thus does not have an enlarged outer dimension in the region of the mutual connection of the steel part 2 with the nitinol part 3, as is the case in the exemplary embodiments according to FIGS. In addition, in the exemplary embodiment according to FIG. 5, an inner connecting sleeve 5 is also provided for reinforcing the mutual connection and fastening.

In all these embodiments, it is advantageous if the connecting sleeves 5 are made of steel, which allows a correspondingly good strength and power transmission.

For the embodiment of FIG. 6 it should be noted that the connecting sleeve 5 is integrally connected to the steel part 2 and in turn arranged radially Pins or rivets 10 is attached to a Nitinol existing neck as Nitinolteil 3. On the steel part 2 can be seen coaxially an internal thread 11 to which a Zuführkatheder or the like can be releasably attached.

The medical device 1, for example a biopsy cannula or also an ASD closure or the like, has at least one part 2 consisting of steel, iron or weldable metal and a part 3 which is connected to it in the position of use and consists of nitinol, Nitinol is not weldable. The connection point 4 of the steel part 2 and / or the Nitinolteils 3 is Röhr- or sleeve-shaped or formed as a nozzle or projection, in particular projection of solid material or as a hollow projection and at least one connection sleeve 5 is provided, which the junction 4 and thus both the Steel part 2 and the Nitinolteil 3 detected and / or overlapped. The connecting sleeve 5 can be positively connected to the steel part 2, by screwing and / or by welding and / or riveting or in one piece and with the Nitinolteil 3 mechanically and / or positively. In this case, the steel part 2 and the Nitinolteil 3 itself be positively connected to each other. The mutual connection can also be made additionally or exclusively via the connecting sleeve 5.

Claims

claims

1. A medical device (1) such as biopsy cannula or ASD closure with at least one made of steel or iron or weldable metal and a thus connected in use position, consisting of Nitinol part, characterized in that the connection point (4) of the steel part (2 ) and / or the Nitinolteils (3) tube or tube-shaped or as a nozzle or as a projection of solid material is formed and that a connecting sleeve (5) is provided which detects both the steel part (2) and the Nitinol- part (3) and / or overlaps that the connecting sleeve (5) with the steel part (2) form-locking, by screwing and / or by welding and / or riveting or in one piece and with the Nitinolteil (3) across, mechanically and / or positively connected is.

2. Apparatus according to claim 1, characterized in that the steel part (2) and the Nitinolteil (3) are themselves positively connected with each other.

3. Apparatus according to claim 2, characterized in that the steel part (2) and the Nitinolteil (3) as a continuous pipe sections, for example, to form a cannula, are formed and touch at their front ends and that one part at least one Having the recess (8) forming recess (6) and the other part in this recess (6) matching, axially projecting projection (7).

4. Device according to one of claims 1 to 3, characterized in that at the contacting end faces on the one hand of the tubular or tube-shaped steel part (2) and on the other hand of the tubular or tubular Nitinol part (3), in particular a needle tip made of Nitinol, at least two recesses (6) on the circumference with rear divisions (8) and in this engaging projections (7) are provided, wherein preferably both recesses (6) are arranged on the Nitinolteil (3).

5. Device according to one of claims 1 to 4, character- ized in that at least one overlapping connection sleeve (5) is arranged on the outside on one of the parts to be joined or on the outside at both parts to be joined.

6. Device according to one of claims 1 to 5, characterized in that the steel part (2) and the Nitinolteil (3) in the connecting region (4) and the connecting sleeve (5) have a circular cross-section.

7. Device according to one of claims 1 to 6, characterized in that the connecting sleeve (5) with at least one of the parts to be joined or with both parts in the position of use at least partially touch contact and / or a sliding or clamping seat.

8. Device according to one of claims 1 to 7, characterized in that the overlapping connection sleeve (5) and the Nitinolteil (3) in the common overlap region in each case at least one transverse or perpendicular to the sleeve center or sleeve axis arranged, continuing opening or perforation or Have bore into which a sleeve (5) and the Nitinolteil (3) at least over part of the extension of the openings or Perforations or holes passing through projection or pin or rivet (10) engages that produces positive locking with the connecting sleeve (5).

9. Device according to one of claims 1 to 8, characterized in that the opening or perforation or bore in the overlapping region and the projection or pin or rivet (10) engaging therein extend radially to the connecting sleeve (5).

10. Device according to one of claims 1 to 9, characterized in that the overlapping part of the connecting sleeve (5) and the steel part (2) by at least one both parts passing through projection or pin or rivet (10) are positively connected in the axial direction ,

11. Device according to one of claims 1 to 10, characterized in that the overlapping sleeve (5) on the outside and / or inside of the steel part (2) and on the nitinolteil (3) is provided and the one or more projections or pins or rivets (10) in each case through the steel part (2) or the Nitinolteil (3) and all connecting sleeves (5) at least over part of the wall thickness.

12. Device according to one of claims 1 to 11, characterized in that the means of an externally arranged connecting sleeve (5) connectable areas of the steel part (2) and the Nitinolteils (3) opposite thereto adjacent areas are deformed or retracted radially inwardly and that the connecting sleeve (2) completely or at least partially fills the extent of this retraction and that the outer side of the connecting sleeve (5) is preferred. has the same outer cross-section as the steel part (2) and / or the Nitmolteil (3) adjacent to the connection point (4).

13. Device according to one of the preceding claims, characterized in that at least one of the connecting sleeves (5) consists of steel.