Patent Description:
At the present time, in the case of non-drug-coated balloon catheters, protective sheaths are put on the balloon catheter by machine, e.g., by means of rollers.

When processing drug-coated balloon catheters, it is necessary to prevent cross contamination. To accomplish this, the components that come in contact with the drug must either be cleaned or exchanged after every product. This makes machine processing complicated and cost-intensive.

Therefore, starting from this, the invention has the goal of providing a process for arranging a protective sheath on a drug-coated balloon catheter that prevents cross contamination of the balloon catheter. Document <CIT> relates to protective sheaths for scaffolds and stents crimped to a delivery balloon.

This is accomplished by a process having the features of claim <NUM>. Advantageous embodiments of this aspect of the invention are indicated in the corresponding subordinate claims and are described below.

A process is proposed for arranging a protective sheath on a drug-coated balloon catheter, the protective sheath having a wall circling in a peripheral direction, this wall surrounding an interior of the protective sheath, and the process having the steps: Arranging the protective sheath on a drug-coated area of the balloon catheter by machine production of a relative motion between the balloon catheter and the protective sheath, the drug-coated area of the balloon catheter being protected, by at least one first and one second flexible film, against coming in contact with a guide for the balloon catheter during the relative motion, or the balloon catheter being held away from the drug-coated area during the relative motion.

The drug-coated area can be, e.g., a drug-coated balloon of the balloon catheter. Furthermore, the drug-coated area can also be a drug-coated stent that is crimped onto a balloon of the balloon catheter.

The wall here can be a continuous wall. Alternatively, however, the wall can also have interruptions in the form of slots or holes, as long as the wall still circles in the peripheral direction.

One embodiment of the process provides that the guide for the balloon catheter have at least one contact element. Such a contact element can have at least one point of contact. In principle, the number of contact elements of the guide is not limited, and can also consist of or comprise multiple elements. A preferred embodiment provides that the guide for the balloon catheter have at least one first and one opposite second contact element, the first contact element being pressed against the balloon catheter with the first film laid between them, and the second contact element being pressed against the balloon catheter with the second film laid between them, and the relative motion involving the balloon catheter being moved relative to the protective sheath, which is at rest, and inserted into the interior of the protective sheath. Alternatively, it is also possible for the protective sheath to be moved over the balloon catheter, which is at rest, causing the latter to be introduced into the interior of the protective sheath.

Furthermore, one embodiment of the process provides that the first contact element be a rotatable first roller, and that the second contact element be a rotatable second roller.

Furthermore, one embodiment of the process provides that for the contact elements to press against the balloon catheter (with the respective film between), they be moved out of a first position toward one another into a second position, in which the two contact elements press against the balloon catheter (with the respective film between) and guide it.

One embodiment of the process provides that the balloon catheter be moved relative to the protective sheath by an advancement of the respective film. Alternatively or additionally, the balloon catheter can be moved by the respective roller, which is rotated by means of a drive.

For the case in which the balloon catheter is moved only by the advancement of the film, the pair of rollers only has the function of a guide. In this case, instead of the two contact elements or rollers it is also possible to use other guides (e.g., a funnel-shaped guide or something similar).

A preferred embodiment of the process further provides that the first film be moved along the first roller with an advancement speed that corresponds to a rotational speed of the first roller, and that the second film be moved along the second roller with an advancement speed that corresponds to a rotational speed of the second roller. This can advantageously ensure that the drug-coated area only comes in contact with a fresh, uncontaminated part of the respective film.

One embodiment of the process further provides that the protective sheath be held by means of a holding device as the balloon catheter is inserted into the interior of the protective sheath.

One embodiment of the process further provides that a longitudinal axis of the balloon catheter (and, in particular, a longitudinal axis of the protective sheath) be vertically oriented as the balloon catheter moves. This vertical processing advantageously makes it possible to save clean room space.

One embodiment of the process further provides that a third and a fourth roller be used to guide the balloon catheter as it is inserted into the interior of the protective sheath, the third and fourth rollers being arranged so that they are displaced by <NUM>° with respect to the first and second rollers in the peripheral direction of the balloon catheter or the protective sheath, in particular the third roller being pressed against the balloon catheter with a third film laid between them, and in particular the fourth roller being pressed against the balloon catheter with a fourth film laid between them.

One embodiment of the process further provides that the respective film be unwound from a feed roller as the balloon catheter is inserted into the interior of the protective sheath and wound up onto a take-up roller. To produce the aforementioned advancement of the respective film (see above), the respective take-up roller can be driven or rotated, e.g., by means of a drive.

Instead of rollers, it is also possible to use another system (a caterpillar track system, grippers, or something similar) to guide and/or move the balloon catheter.

One embodiment of the process further provides that the balloon catheter have a proximal end and an opposite distal end section, the drug-coated area being arranged at the distal end section of the balloon catheter, and the balloon catheter being inserted into the interior of the protective sheath with the proximal end first, or the protective sheath being arranged on the balloon catheter from proximal end of the balloon catheter.

One embodiment of the inventive process that represents an alternative especially with respect to the rollers provides that the aforementioned relative motion be produced with the help of a first and a second contact element, the two contact elements being movable out of a first position toward one another into a second position.

One embodiment of the process provides that after the balloon catheter is inserted into the interior of the protective sheath, the two contact elements be moved into the second position, so that the two contact elements reach behind one end of the protective sheath or grasp or hold one section of the protective sheath, the balloon catheter being held by means of a holding device, and the two contact elements being moved along the balloon catheter, which is at rest, carrying along the protective sheath, the protective sheath being pushed over the drug-coated area.

One alternative embodiment of the process further provides that after the balloon catheter is inserted into the interior of the protective sheath, the two contact elements be moved into the second position, so that the two contact elements grasp or hold one section of the balloon catheter outside the drug-coated area, the protective sheath being held by means of a holding device, and the two contact elements being moved away from the protective sheath, which is at rest, carrying along the balloon catheter, so that the drug-coated area is inserted into the interior of the protective sheath, in particular, pulled into the interior of the protective sheath.

To move the protective sheath or to move the balloon catheter, the contact elements can be moved in the horizontal direction (in this case the balloon catheter and the protective sheath extend horizontally) or in the vertical direction (in this case the balloon catheter and the protective sheath extend vertically).

The drug-coated area can be a drug-coated balloon of the balloon catheter, or a drug-coated stent of the balloon catheter that is crimped onto a balloon of the balloon catheter.

All embodiments of the process can further provide that as the protective sheath is arranged on the drug-coated area, the protective sheath is rotated with respect to the balloon catheter about a longitudinal axis of the protective sheath, or that as the protective sheath is arranged on the drug-coated area the balloon catheter is rotated with respect to the protective sheath about a longitudinal axis of the balloon catheter. This is especially advantageous if the drug-coated area is formed by the balloon of the balloon catheter, so that a folding of the balloon is not disturbed, i.e., is maintained as the protective sheath is pulled over.

The inventive protective sheath assembly can also be integrated into the balloon folding process: after folding, the catheter is pulled out of the folding system. This movement in combination with the holding device can also be used to assemble the protective sheath.

Another aspect of this invention relates to a device for arranging a protective sheath on a drug-coated area of a balloon catheter.

To arrange the protective sheath on the drug-coated area of the balloon catheter, the device is configured to produce a relative motion between the balloon catheter and the protective sheath, the device further having a first and a second film, which are configured to prevent contact between the drug-coated area and a guide of the device during the relative motion, the guide being designed to guide the balloon catheter, or the device being designed to hold the balloon catheter away from the drug-coated area during the relative motion.

According to one embodiment of the device, the guide has at least one first contact element and one second contact element that is opposite the first, the first contact element being pressable against the balloon catheter with the first film laid between them, and the second contact element being pressable against the balloon catheter with the second film laid between them. To accomplish this, one embodiment of the device provides that for the contact elements to press against the balloon catheter (with the respective film between), they be movable out of a first position toward one another into a second position, the two contact elements being configured so that in the second position they press against the balloon catheter (with the respective film between) and guide it.

One embodiment of the device further provides that the first contact element be a rotatable first roller, and that the second contact element be a rotatable second roller.

One embodiment of the device further provides that the device be configured to move the balloon catheter relative to the protective sheath by advancing the respective film, and/or by rotating the respective roller by means of a drive of the device.

One preferred embodiment of the device further provides that the first film be movable along the first roller with an advancement speed that corresponds to a rotational speed of the first roller, and the second film be movable along the second roller with an advancement speed that corresponds to a rotational speed of the second roller.

One embodiment of the device further provides that the device have a holding device that is designed to hold the protective sheath as the balloon catheter is inserted into the interior of the protective sheath.

One embodiment of the device further provides that the device have a third and a fourth roller to guide the balloon catheter as it is inserted into the interior of the protective sheath, the third and fourth rollers being arranged so that they are displaced by <NUM>° with respect to the first and second rollers, in particular the third roller being pressable against the balloon catheter with a third film laid between them, and in particular the fourth roller being pressable against the balloon catheter with a fourth film of the device laid between them.

One embodiment of the device further provides that to unwind the respective film as the balloon catheter is inserted into the interior of the protective sheath, the device have a feed roller, and that the device have a take-up roller to wind up the respective film. To produce the aforementioned advancement of the respective film (see above), the device can be designed, e.g., to drive or rotate the respective take-up roller, e.g., by means of a drive.

An alternative embodiment of the device provides that the device be configured to produce the aforementioned relative motion with the help of a first and a second contact element of the device, the two contact elements being designed to be moved out of a first position toward one another into a second position.

One embodiment of the device further provides that these two contact elements be movable into the second position so that the two contact elements reach behind one end of the protective sheath or grip a section of the protective sheath if the balloon catheter is held as intended by means of a holding device. Furthermore, the two contact elements are preferably configured to be moved along the balloon catheter, carrying along the protective sheath, to push the protective sheath over the drug-coated area of the balloon catheter.

One embodiment of the device further provides that these two contact elements be movable into the second position to grip a section of the balloon catheter outside the drug-coated area, the two contact elements preferably being designed to be moved away from the protective sheath, which is at rest, carrying the balloon catheter along with them, if the protective sheath is held by means of a holding device of the device, in order to insert the drug-coated area into the interior of the protective sheath, in particular to pull the drug-coated area into the interior of the protective sheath.

One embodiment of the device further provides that the device be configured to rotate the protective sheath with respect to the balloon catheter about a longitudinal axis of the protective sheath as the protective sheath is arranged on the drug-coated area. Alternatively, the device can be designed to rotate the balloon catheter with respect to the protective sheath about a longitudinal axis of the balloon catheter as the protective sheath is arranged on the drug-coated area.

This invention advantageously allows machine positioning of a protective sheath on drug-coated balloons or stents and prevents cross contamination of the respective drug-coated area as this is done.

Sample embodiments of the invention and features and advantages of this invention are explained below using the figures. The figures are as follows:.

<FIG> show different embodiments of a process or a device for arranging a protective sheath <NUM> on a drug-coated balloon catheter <NUM>, the protective sheath <NUM> having a wall <NUM> circling in a peripheral direction U, this wall surrounding an interior <NUM> of the protective sheath <NUM>, the process having at least the following step: Arranging the protective sheath <NUM> on a drug-coated area 30a of the balloon catheter <NUM> by machine production of a relative motion between the balloon catheter <NUM> and the protective sheath <NUM>, the drug-coated area 30a of the balloon catheter <NUM> being protected, by at least one first and one second flexible film <NUM>, <NUM>, against coming in contact with a guide <NUM> for the balloon catheter <NUM> during the relative motion (see <FIG>), or the balloon catheter <NUM> being held away from the drug-coated area 30a during the relative motion (see <FIG>).

The drug-coated area 30a can be the balloon <NUM> of the balloon catheter <NUM> (or a section of the balloon <NUM>). Alternatively, the drug-coated area 30a can also be a stent 30b that sits on a balloon <NUM> of the balloon catheter <NUM>. Such a balloon <NUM> or stent 30b can be used, e.g., in an angioplasty procedure to expand a vessel of a patient, or to hold it open. The balloon catheter <NUM> also has, in particular, an inner lumen <NUM> for deploying the balloon <NUM> and, in particular, X-ray markers <NUM>.

In order to save space in a clean room in which the respective process is preferably carried out, the balloon catheters <NUM> can be processed in the vertical orientation (as shown in <FIG>). In particular, the protective sheath <NUM> is assembled after the respective balloon <NUM> is folded and fixed.

The protective sheath <NUM> can, e.g., be transported, via a transport system (e.g., having a slide or a linear axis, or something similar), into a holding device <NUM>, <NUM> beneath the hanging balloon catheter <NUM> (see <FIG>). Next, the holding device <NUM>, <NUM> fixes the protective sheath <NUM> (see <FIG>). To accomplish this, the holding device <NUM>, <NUM> can have, e.g., two movable holding jaws <NUM>, <NUM>. Above the holding device <NUM>, <NUM> there are two contact elements <NUM>, <NUM> in the form of a first and a second roller <NUM>, <NUM>, which form a pair of rollers. The two rollers <NUM>, <NUM> can be moved between a first position, in which the films <NUM>, <NUM> do not lie against the catheter <NUM>, into a second position (toward one another), in which the rollers <NUM>, <NUM> press the respective film <NUM>, <NUM> against the balloon catheter <NUM> and, accordingly, guide or advance the catheter <NUM> into the protective sheath <NUM>. That is, the purpose of the roller pair <NUM>, <NUM> is to push the balloon catheter <NUM> in a guided manner into the interior <NUM> of the protective sheath <NUM> (see <FIG>). As this is done, the rotational speed and the advancement speed of the catheter <NUM> are preferably synchronized. After the assembly step, the roller pair <NUM>, <NUM> opens, i.e., the two contact elements <NUM>, <NUM> are separated from one another, and the holding device <NUM>, <NUM> and the catheter <NUM> are freed for the further processing (see <FIG>).

For the processing of drug-coated balloon catheters <NUM>, the roller pair <NUM>, <NUM> is, as can be seen from <FIG>, protected by retractable films <NUM>, <NUM>. The advancement speed of the respective film <NUM>, <NUM> is preferably synchronized with the rotational speed of the respective roller <NUM>, <NUM>. This can ensure that the balloon catheter <NUM> always only comes in contact with the uncontaminated part of the film <NUM> or <NUM>.

As can also be seen from <FIG>, as the balloon catheter <NUM> is inserted into the interior <NUM> of the protective sheath <NUM> the respective film <NUM>, <NUM> can be unwound from a feed roller <NUM> and wound up onto a take-up roller <NUM>. It is conceivable to make the catheter <NUM> move into the protective sheath <NUM> by advancing the respective film <NUM>, <NUM>, e.g., by rotating or driving the respective take-up roller <NUM> by means of a drive. Alternatively or additionally, the respective roller <NUM>, <NUM> can be rotated by means of a drive. For the case in which the advancement is produced by the films <NUM>, <NUM>, the rollers <NUM>, <NUM> only serve to guide the films <NUM>, <NUM> or to provide them with contact pressure against the balloon catheter <NUM>.

<FIG> show an alternative embodiment of the inventive process or of an inventive device.

The balloon catheter <NUM> has a proximal end 3a and an opposite distal end section 3b, the drug-coated area <NUM> being arranged at the distal end section 3b of the balloon catheter <NUM>, and the balloon catheter <NUM> first being inserted into the interior <NUM> of the protective sheath <NUM> with the proximal end 3a first, or alternatively the protective sheath <NUM> being arranged on the balloon catheter <NUM> from proximal end 3a of the balloon catheter <NUM> (see <FIG>). This step can take place, for example, before the assembly of a Luer connection or also before the drug coating itself.

To push the protective sheath <NUM> down onto the drug-coated area 30a of the catheter <NUM>, a first and a second contact element <NUM>, <NUM> are now provided, which are movable out of a first position toward one another into a second position, in which the two contact elements <NUM>, <NUM> reach behind one end 2a of the protective sheath <NUM> (see <FIG>).

Claim 1:
A process for arranging a protective sheath (<NUM>) on a drug-coated balloon catheter (<NUM>), the protective sheath (<NUM>) having a wall (<NUM>) circling in a peripheral direction (U), this wall surrounding an interior (<NUM>) of the protective sheath (<NUM>), the process having at least the following step:
- Arranging the protective sheath (<NUM>) on a drug-coated area (30a) of the balloon catheter (<NUM>) by machine production of a relative motion between the balloon catheter (<NUM>) and the protective sheath (<NUM>), wherein
- the drug-coated area (30a) of the balloon catheter (<NUM>) is protected, by at least one first and one second flexible film (<NUM>, <NUM>), against coming in contact with a guide (<NUM>) for the balloon catheter (<NUM>) during the relative motion,
or
- the balloon catheter (<NUM>) is held away from the drug-coated area (30a) during the relative motion, wherein the relative motion is produced with the help of a first and a second contact element (<NUM>, <NUM>), the two contact elements (<NUM>, <NUM>) being movable out of a first position toward one another into a second position, and after the balloon catheter (<NUM>) is inserted into the interior (<NUM>) of the protective sheath (<NUM>), the two contact elements (<NUM>, <NUM>) are moved into the second position, so that the two contact elements (<NUM>, <NUM>) reach behind one end (2a) of the protective sheath (<NUM>) or grip a section of the protective sheath (<NUM>), the balloon catheter (<NUM>) being held by means of a holding device, and the two contact elements (<NUM>, <NUM>) being moved along the balloon catheter (<NUM>), carrying along the protective sheath (<NUM>), the protective sheath (<NUM>) being pushed over the drug-coated area (30a).