The invention relates to a medical device for releasing in a hollow organ and to an insertion system for medical devices.
A device for releasing in a hollow organ, having the features of the preamble of claim 1, and an insertion system are known from EP 1 157 673 A2, for example, which discloses a stent for transluminal implantation in hollow organs and also an insertion catheter for such a stent. For implantation, the stent located in the compressed state in the insertion catheter is advanced to the location to be treated in the hollow organ and is positioned there. To release the stent, the outer sheath of the insertion catheter is drawn back, such that the stent expands and supports the hollow organ.
In the event that the position of the stent released from the insertion catheter has to be corrected, the stent should be able to be repositioned by the insertion catheter. For this purpose, the stent is usually fixed axially on a guide wire of the insertion catheter, such that the stent can be drawn back together with the guide wire into the insertion catheter. In the stent system according to EP 1 157 673 A2, the ability to reposition the stent is afforded by a positioning element that is secured on the guide wire or mandrel of the insertion catheter. The positioning element has several recesses which are distributed on the circumference and into which correspondingly shaped retaining segments at the axial end of the stent engage with a form fit. By means of the form-fit connection between the positioning element and the stent, a locking effect is provided that acts in the axial direction and permits a repositioning of the stent.
In the field of interventional neurology, particularly in the field of stent and catheter design, the trend in development work is toward miniaturization. If the repositioning functionality described above is to be incorporated into the design, the limits of what is possible and of what can be produced are soon reached. This also applies to the stent system that is known from EP 1 157 673 A2 since, for reasons of strength, the positioning element must have sufficient thickness in the wall area between the recesses, and this makes miniaturization difficult or prevents it.
A further stent system is known from U.S. Pat. No. 7,303,580 B2, in which the stent is fixed on the guide wire by eyelets and by rivets engaging through the latter, which protrude into the lumen of the stent and engage behind a limit stop on the guide wire. This kind of fixing arrangement cannot be made smaller and also has the disadvantage that, in the implanted state, the eyelets protrude into the lumen of the stent and thus impede the flow of blood.
The object of the invention is to make available a medical device for releasing in a hollow organ, which device satisfies the condition for an axial locking effect in an insertion system for positioning or repositioning the device, wherein the device is well suited to a small construction. It is also the object of the invention to make available an insertion system for medical appliances, which insertion system has a device for releasing in a hollow organ, and which insertion system can be easily miniaturized.
According to the invention, the object is achieved, in respect of the medical device, by the subject matter of claim 1 and, in respect of the insertion system, by the subject matter of claim 9.
The invention is based on a medical device for releasing in a hollow organ, with a hollow cylindrical body that can be converted to a compressed state having a reduced diameter and to an expanded state having an enlarged diameter, the body having a locking means at its proximal and/or distal axial end. The locking means comprises at least one retaining element connected to the body by a connecting segment. The retaining element and the body are decoupled by the connecting segment in such a way that the retaining element has a smaller curvature than the body in the compressed state, in particular in the compressed state of the body, or generally in the compressed state of the device. Accordingly, the radius of curvature of the retaining element is greater than the radius of curvature of the body in the compressed state. The retaining element is less strongly curved than the body. The connecting segment connects the retaining element and the body elastically. The contour of the retaining element in the compressed state of the body protrudes beyond the outer circumference of the body in such a way that the retaining element can be moved radially inward relative to the body into a locking position by the inner wall of an insertion system.
The invention is moreover based on an insertion system for medical appliances having a device for releasing in a hollow organ, with a hollow cylindrical body that can be converted to a compressed state having a reduced diameter and to an expanded state having an enlarged diameter, the body having a locking means at its proximal and/or distal axial end. The locking means comprises at least one retaining element connected elastically to the body by a connecting segment. The retaining element and the body are decoupled by the connecting segment in such a way that the retaining element has a smaller curvature than the body in the compressed state, in particular in the compressed state of the body, or generally in the compressed state of the device. The contour of the retaining element touches the inner wall of the insertion system at at least one location, in such a way that that the retaining element is moved radially inward relative to the body into a locking position and cooperates with an element that is arranged in the insertion system and that fixes the body.
Thus, in the compressed state of the device, the retaining element is less curved, that is to say flatter, than the body. The compression of the device takes place substantially, in particular completely, in the form of a compression of the body. The retaining element is decoupled from the body, such that the compression of the body does not substantially lead to a change in shape of the retaining element.
In the context of the invention, the medical device for releasing in a hollow organ is claimed itself, that is to say independently of the insertion system, and an insertion system comprising such a medical device is also claimed.
The invention has the advantage that the medical device requires minimal space in the insertion system. In addition, the invention can be very easily produced since no additional positioning elements are needed.
In a preferred embodiment of the invention, one to four retaining elements are distributed on the circumference. This has the effect that the retaining elements can be formed with a sufficiently large circumferential extent such that the greatest possible inwardly directed radial movement of the retaining elements can be achieved. The retaining elements can be spaced apart on the circumference in the compressed state of the body. The free space between the retaining elements in the compressed state of the body avoids the retaining elements colliding with each other during the movement into the locking position.
In the compressed state of the body, the extent L2 of a retaining element transverse to the longitudinal direction of the body can measure at least 5% of the total outer circumference of the body, in particular at least 7%, at least 10%, at least 12%, at least 14%, at least 16%, at least 18%, at least 20%, at least 22%, at least 24%, at least 26%, at least 28%, at least 30%, of the total outer circumference of the body.
The abovementioned lower limits for the transverse extent of a retaining element have proven expedient in ensuring a sufficiently great inward radial movement of the retaining elements. The radial movement increases as the size of the retaining elements increases.
Preferably, in the compressed state of the body, the extent L2 of a retaining element transverse to the longitudinal direction of the body measures at most 32% of the total outer circumference of the body (10), in particular at most 30%, at most 28%, at most 26%, at most 24%, at most 22%, at most 20%, of the total outer circumference of the body. This creates different upper limits that are adapted to a different number of retaining elements.
A retaining element can be substantially circular. The circular shape of the retaining elements is particularly easy to produce.
In another embodiment, the retaining element comprises an X-ray marker and thus performs a dual function, that is to say, on the one hand, the locking function and, on the other hand, the detectability of the medical device.
The connecting segment can comprise at least one web arranged in the longitudinal direction of the body. The web provides a possibility of producing the elastic connection between the retaining element and the body. In the insertion system, provision can be made that the element arranged in the insertion system comprises a guide wire having at least one projection, wherein the retaining element engages behind the projection in the locking position. This embodiment is particularly easy to produce, since the projection is not subject to any particular geometric requirements.
In another embodiment, the guide wire has at least two projections between which the retaining element engages in the locking position. This has the effect that the retaining element and thus the medical device is fixed in both axial directions, such that the device can be moved in both axial directions by actuation of the guide wire.
The invention is explained in more detail below on the basis of illustrative embodiments and with reference to the attached schematic drawings, in which:
a shows a perspective side view of an insertion system with a stent and a guide wire, wherein the retaining elements of the stent are located outside the insertion system;
b shows a view of the system according to
c shows a view of the system according to
a shows the system according to
b shows a view of the system according to
c shows a view of the system according to
a shows a schematic cross section through an insertion system according to another illustrative embodiment, wherein the section runs between the retaining elements and the body;
b shows a cross section through the system according to
a,
1
b and 1c show an insertion system 15 for medical appliances having a device for releasing in a hollow organ. In the context of the invention, protection is claimed both for the medical device itself, that is to say without the insertion system, and also for the combination of the insertion system with the medical device. The medical device can be a stent, in particular for interventional neurology. The invention is not limited to stents and instead can be used generally for medical implants that require repositioning during implantation. The invention is also applicable to medical appliances, for example clot retrievers, that are not implanted but are temporarily released in the body. The invention is thus universally applicable in the field of medical technology and, by virtue of its simple design, has great economic potential.
All of the features disclosed below in connection with the stent according to
As can be seen in
The locking means 11 comprises at least one retaining element 12, which is connected to the body 10 by a connecting segment 13. The retaining element 12 and the connecting segment 13 together form a flexible wing or a tongue, of which the function is to fix the stent axially in the insertion system 15. In the illustrative embodiment according to
a shows that the retaining elements 12 in the expanded state are spaced apart on the circumference. A collision of the retaining elements 12 during the movement into the locking position (
The material of the retaining elements 12 can be such that they serve as X-ray markers. In this way, the retaining elements 12 perform a dual function, that is to say, on the one hand, the mechanical locking of the stent on the guide wire 18 and, on the other hand, the detectability of the stent during implantation.
The body 10 forms a hollow cylindrical wall, which is formed, for example, as a closed-cell stent design. An open-cell lattice structure is likewise possible. The lattice structure can be produced by laser cutting, for example. Other types of production, for example by sputtering in conjunction with a lithography method or by a laser removal method, are likewise possible.
The connecting segment 13 forms an elastic connection between the retaining element 12 and the body 10. The elastic connection has the effect that the retaining elements 12 can move radially inward relative to the body 10 when an axial movement of the body 10 applies a radially inwardly acting force to the retaining elements 12. The elastic connection generates a restoring force, which moves the retaining elements 12 back to the opened-out position after the stent is withdrawn from the insertion system 15. In the opened-out, expanded position of the retaining elements 12, the latter extend in the longitudinal direction of the stent and thus do not protrude into the stent lumen.
The connecting segment 13 is adapted such that the retaining elements 12 and the body 10 are decoupled. For this purpose, the connecting segment can have a smaller transverse extent, i.e. a smaller extent transverse to the longitudinal axis of the stent, than the transverse extent of a retaining element 12. Other possible ways of decoupling are conceivable, for example by a suitable design of the lattice structure of the body 10.
The decoupling has the effect that the retaining elements 12 in the compressed state are less strongly curved or have a greater radius of curvature than the body 10. This means that the reduction of the stent diameter caused by the crimping into the insertion system does not have an effect on the curvature or generally on the geometry of the retaining elements 12. The curvature of the retaining elements 12 is therefore independent of the curvature of the body 10 in the compressed state. The different curvature of the retaining elements 12 and of the compressed body 10 can be seen clearly in
The curvature of the retaining elements 12 is in the circumferential direction of the body 10. The curvature or the radius of curvature of the retaining element 12 is constant in the different states (compressed, expanded) that the body 10 adopts. As can be seen in
A further property of the retaining elements 12 is that their contour, in the compressed state of the body 10, protrudes beyond the outer circumference thereof and thus beyond the internal diameter of the insertion system 15. This feature of the stent can be ascertained from the fact that the stent, as shown in
The connecting segment 13 can be provided by one, two or more webs 14, for example, which connect a proximal end of the retaining elements 12 to the distal axial end 10a of the stent 10. In the illustrative embodiment according to
It is also possible that the connecting means or the connecting segment 13 and the retaining element 12 are formed in one piece, in which case the retaining element 12 is profiled and thus forms a connecting segment. For example, as in the plan view according to
The retaining element 12 can have the form of a tongue or of a wing that narrows in the direction of the body 10.
Generally, the width of the connecting segment 13 is smaller than the width of the retaining element 12 extending transverse to the longitudinal direction of the body 10. This geometry applies to single and also to multiple connecting segments 13 which, for example, comprise several webs arranged alongside one another (
It is also possible to use, as connecting means or connecting segment 13, the lattice structure in the area of the axial end edge of the body 10, in which case the transition between the retaining element 12 and the lattice structure is such that a change in the radius of curvature of the body 10 during the crimping does not transfer to the radius of curvature of the retaining element 12.
The ratio between the length L2 (see
The maximum transverse extent L2 is determined by the diameter of the insertion system 15, such that an insertion of the retaining elements 12 into the insertion system 15 is possible.
As can be seen in
This has the effect that great freedom of movement is made available to the retaining element 12 for the radial movement. It is also possible that the distance L3 between the body 10 and the retaining element 12 is very small, such that the retaining element 12 is arranged practically on the body 10. The decoupling of the body 10 and of the retaining element 12 for the purpose of maintaining a constant radius of curvature of the retaining element 12 is achieved by a suitable transition between the retaining element 12 and the axial edge of the body 10, for example by a flexible lattice structure in the axial edge area of the body 10.
The mode of operation of the stent or generally of the medical device for releasing in a hollow organ in connection with the insertion system is illustrated in
The insertion system can comprise, for example, an insertion catheter or a microcatheter and is not subject to any particular restrictions. In the system illustrated, it is a tube segment of a microcatheter for example.
As can be seen by comparing the views according to
The circular shape of the retaining elements 12 facilitates the insertion of the retaining elements 12 into the insertion system 15, since the outer edge of the insertion system 15 can slide on the curved edge of the retaining elements 12. Other profiles of the retaining elements 12 are possible, in particular profiles with a curved shape in the proximal area of the retaining elements 12. In the illustrative embodiment according to
In the illustrative embodiment according to
It is clear from
a shows that the width L1 of the connecting segment 13 on the body 10 is smaller than the width L2 of a retaining element. In this way, the point of articulation of the wing on the body 10 is narrower than the area of the wing away from the body, thereby producing, on the one hand, the decoupling of the body and of the retaining element 12 for generating different curvatures and, on the other hand, the flexible connection between the body 10 and the retaining element 12.
The ratio D1/D2 between the diameter D1 and the diameter D2 comprises the following ranges:
D1/D2≧1.2 (lower limit)
D1/D2≦10 (upper limit)
The lower limit can be varied as follows:
D1/D2≧1.4, in particular ≧1.6, in particular ≧1.8, in particular ≧2, in particular ≧2.2, in particular ≧2.4, in particular ≧2.6, in particular ≧2.8, in particular ≧3, in particular ≧3.2, in particular ≧3.4, in particular ≧3.6, in particular ≧3.8, in particular ≧4, in particular ≧4.2, in particular ≧4.4, in particular ≧4.6, in particular ≧4.8, in particular ≧5, in particular ≧5.2, in particular ≧5.4, in particular ≧5.6, in particular ≧5.8, in particular ≧6, in particular ≧6.2, in particular ≧6.4, in particular ≧6.6, in particular ≧6.8, in particular ≧7, in particular ≧7.2, in particular ≧7.4, in particular ≧7.6, in particular ≧7.8, in particular ≧8, in particular ≧8.2, in particular ≧8.4, in particular ≧8.6, in particular ≧8.8, in particular ≧9, in particular ≧9.2, in particular ≧9.4, in particular ≧9.6, in particular ≧9.8.
The upper limit can be varied as follows:
D1/D2≦9.8, in particular ≦9.8, in particular ≦9.6, in particular ≦9.4, in particular ≦9.2, in particular ≦9, in particular ≦8.8, in particular ≦8.6, in particular ≦8.4, in particular ≦8.2, in particular ≦8, in particular ≦7.8, in particular ≦7.6, in particular ≦7.4, in particular ≦7.2, in particular ≦7, in particular ≦6.8, in particular ≦6.6, in particular ≦6.4, in particular ≦6.2, in particular ≦6, in particular ≦5.8, in particular ≦5.6, in particular ≦5.4, in particular ≦5.2, in particular ≦5, in particular ≦4.8, in particular ≦4.6, in particular ≦4.4, in particular ≦4.2, in particular ≦4, in particular ≦3.8, in particular ≦3.6, in particular ≦3.4, in particular ≦3.2, in particular ≦3.
The lower and upper limits mentioned above can be combined with one another to form upwardly and downwardly limited ranges.
An example of the greater diameter D1 is D1=0.7 mm. D1 can vary in the range of 0.7-0.1 mm, where all intermediate values in the abovementioned range can be used for the diameter D1.
When the body 10 or the tube segment is pushed out, the angle change W1 is canceled again, and the retaining elements 12 return to the initial state. Thus, the state shown in
In summary, in this illustrative embodiment, the stent ends lie, in the rest state, on the same circumferential plane of the stent as the body 10. The radially inward bending of the retaining elements 12 is effected by the contact with the inner wall 16 of the catheter. The advantage of this is that the inwardly protruding profile of the stent during delivery is used to fix the stent in the axial direction. In the implanted state, the profile bears on the vessel wall, such that the danger of clot formation is considerably reduced.
10 body
10
a axial end
11 locking means
12 retaining element
13 connecting segment
14 web
15 insertion system
16 inner wall
17 location
18 element
19 guide wire
20 projection
Number | Date | Country | Kind |
---|---|---|---|
10 2009 021 039.3 | May 2009 | DE | national |
Filing Document | Filing Date | Country | Kind | 371c Date |
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PCT/EP2010/002937 | 5/12/2010 | WO | 00 | 12/1/2011 |