DE102007021144A1 - Recycled catheter system with a stent - Google Patents

Abstract

It is proposed a catheter system with stent, wherein at least a part of the catheter system is processed. Furthermore, a treatment method for catheter systems is proposed, wherein at least part of the catheter system is prepared so that it can be used several times. Another object of the invention is a storage device for a catheter system already in use.

Description

The The invention relates to a catheter system having a stent.

Catheter systems are well known. From the German patent application DE 195 32 288 A1 For example, a balloon catheter is known that can be reused first for vascular dilation in a patient and then for stent implantation in the same patient. The German patent application DE 102 09 993 A1 describes a device for the preparation of balloon catheters. In this case, the catheters are rinsed, testing, sterilization or folding of the catheter or sections of the catheter does not take place. However, the catheter systems used and the device for processing already used catheter systems have the disadvantage that the catheter systems already used, as in the document DE 102 09 993 A1 described, can not be used again for another patient. For example, without sterilization and testing of the catheter already in use, the use of the catheter system by another person can not be thought of at all. In addition, the flushed catheter according to the document DE 102 09 993 A1 no longer be used for every type of treatment. For example, a stent can only be attached to a precisely folded balloon catheter. Thus, a stent would no longer be displaced by a merely flushed catheter without a precisely folded balloon and thus be safely attached to the balloon and thus no stent implantation that meets the safety standards of today, more possible.

It was therefore the object of the present invention, the previously used To further develop catheter systems and treatment processes in such a way that in the treatment of different patients with one already used catheter system essentially all types of treatment (such as the stent implantation) performed can be as well as with a new catheter system. In addition, the use of an already used catheter system should to be essentially as safe for a patient like the use of an unused, new catheter system.

Solved The task involves using a catheter system with a stent at least a part of the catheter system is processed. Under a treated part should be understood as part of a catheter system already used in the treatment of a first patient and then processed. After processing should this recycled part in the treatment of another, second Patients are used. Through the preparation of the part is thereby advantageously ensured that even after the use of the Part of a first patient for a subsequent second patients do not face higher risks, as with the treatment with a new, not yet used part. Farther are by the catheter system according to the invention essentially all types of treatment possible because the catheter system, as new, unused catheter systems also have a stent. In addition, at least one treated part in the catheter system Material consumption significantly reduced, for example, only damaged parts are replaced or repaired need, or remaining in the body assemblies (For example, the stent) must be replaced. Advantageously, thus does not always have the entire catheter system discarded after use.

Prefers the catheter system includes as part of at least one balloon catheter and / or a guide catheter. In the case of a balloon catheter is preferably a balloon of the balloon catheter smoothed. The Smoothing is preferably done in the way that the balloon is introduced into a tempered sleeve. The Sleeve preferably has a diameter, the essentially minimally smaller than or equal to a specified diameter the inflated balloon is. Will the balloon at least open brought the specified diameter, the balloon surface passes to the tempered sleeve, causing wrinkles or creases in the balloon surface, similar to an ironing process, be smoothed. Regarding the smoothing of the balloon with a tempered sleeve respectively Molded sleeve is intended to the description of the patent application with internal reference PY0013, brought on 3 May 2007, be referred to the German Patent and Trademark Office. The same said application is intended to be considered part of this disclosure become. Alternatively, the balloon but also by a Ironing process be smoothed, with this no tempered sleeve is used. The smoothing the balloon is especially important with balloon catheters already in use, because the balloon by a preceded treatment on a first Patients have material imprints in the form of creases. The creases arise, for example, by the attachment a stent on the balloon for stent implantation in a first patient. However, these creases prevent an exact folding of the Balloons responsible for the subsequent proper dilatation of the balloon is necessary in a second patient. Also difficult or poor folding prevents attachment of a stent on the balloon.

Creases of a balloon should be understood to mean all changes in shape and / or changes in the diameter of the balloon. For example, material impressions of a stent on the balloon are understood as creases. But also vascular imprints in the balloon, which are caused for example by a dilatation of a balloon, for example, in a heavily calcified vessel in the form of a negative impression of the calcification on the balloon should be regarded as creases.

Of the The fixed diameter of a balloon is the diameter of the balloon at a fixed overpressure acting on it. Of the The specified diameter depends on the size of the balloon, the balloon being different depending on the field of application may have fixed diameters. In general, a fixed overpressure, the to act on the balloon, and / or a fixed diameter of the balloon indicated by the manufacturer of the balloon catheter. Of course you can the balloon also widened beyond the specified diameter without damaging the balloon. For the treatment process according to the invention can For example, the balloon slightly under or over or widened to a nominal diameter. All three Variants are possible without damaging the balloon. Which of the variant will be chosen for the balloon is essentially dependent on the treatment process. However, each of the three variants can be defined as a diameter of the balloon.

Of the Balloon catheter preferably has at least one balloon and / or a guidewire channel and / or another channel and / or a pump and / or an integrated guide element and / or a guide element and / or a connection. Prefers The catheter system also includes a lock. When the balloon is acting it is preferably a balloon, as in the case of balloon catheters for Vessel widening or dilating a stent is used. Preferably, the balloon is in one crimped state of the stent. Preferably, the balloon has markers on, particularly preferred Rötgenmarker. This is the Balloon during treatment, for example at a Stenosis treatment, visible on the radiograph. The exact Placement of the balloon and stent can thus be advantageously checked become. Through the at least one guidewire channel is prefers the guide element during use of the catheter system. The guide element is preferred a thin wire, as with over-the-wire catheters or Rapid Exchange catheters is used. Through the other channel is preferably gas or liquid passed, the balloon unfolded by the gas or liquid respectively is widened. The integrated guide element is located For example, in a fixed-wire balloon, since in this catheter system the Guide element is integrated in the balloon. The pump is preferably connected to the terminal, wherein upon actuation the pump, a pressure for the deployment of the balloon can be generated. The lock can be preferably used in a blood vessel. Particularly preferably, a catheter system consists only of parts that already processed. The more often the processed Parts can be used on different patients the lower the material consumption, because the parts also after a multiple use must not be discarded. It is understood that even only parts of the catheter system or even only parts of the balloon catheter or the guiding catheter and other items for the treatment on a second patient can be replaced with new ones. For example, a balloon catheter may be prepared, however the guide element of the used balloon catheter against a new, unused guide element to be replaced. In another case, for example, the connection of a balloon catheter exchanged, the other items of the balloon catheter however, be prepared.

Especially Preferably, at least a portion of the catheter system has a manufacturer identification as License plate on. Particular preference is given to the processed Parts of the catheter system on the plate.

Prefers the indicator has information for the preparation. Preferably is noted by the flag, for example, how common a part has already been prepared, which process for reprocessing was used, which fault tolerances the part has and / or when and / or where the last preparation took place. Of course Other information is also conceivable that is not directly related to the Processing have to do. For example, the indicator details at expiration date, place of manufacture or date of manufacture of the part. Preferably, the license plate, in the license plate stored information, via at least one transmission channel, transmitted to a receiving unit. The receiving unit is preferably located on devices that for the treatment process can be used. Advantageously takes over thus the license plate transponder functions.

The Equipment used for the treatment process are, for example, flushing devices, drying units, Measuring stations, sterilization devices, crimping devices, Folding devices and / or tempering devices.

Furthermore, preferably, the at least one part of the catheter system that is prepared has specified minimum material thicknesses and / or materials alarten and / or component sizes and / or component shapes and / or connections. Due to these properties, the part is preferably in the treatment process to the devices that are used in the treatment process, connectable and / or it stands by these properties mechanical loads that act during the treatment process but also by the multiple use of the part. For example, the further channel is divided into a proximal and a distal shaft, wherein the transition from the proximal to the distal shaft is preferably reinforced. Preferably, the balloon tip is reinforced in the region of the guide element exit point. Advantageously, the part is thus adapted to the treatment process and the multiple use, so that the probability of damage can be reduced and the condition for repair or preparation of the part is given.

One Another object of the present invention is a balloon catheter for use in the catheter system according to the invention. The balloon of the balloon catheter is folded and / or tempered, as described in the subsequent preparation process. It It is understood that with a balloon catheter already in use the balloon first cleaned, checked and smoothed was done before folding and / or annealing. By the Annealing and folding will be beneficial for the balloon reprocessed to a second patient. By the folding is the attachment of a stent on the already used Balloon of the used balloon catheter possible, so that the balloon catheter also in the subsequent second patient can be used for stent implantation. The tempering fixed the folding of the balloon, which causes the balloon even after peeling off a protective cover, the so-called Faltfixierung, not unfolded immediately. In addition, small creases, which are caused by the folding, advantageous by the annealing be smoothed.

One Another object of the invention is a treatment process for catheter systems, wherein the balloon catheter and / or the guiding catheter during the dressing process a plurality of measurements is subjected. Especially preferred each balloon catheter and / or each guide catheter subjected to a plurality of measurements. Of course However, it is also possible that some measurements are carried out only on a random basis become. Particularly preferred are already used catheter systems subjected in the treatment process of a plurality of measurements. By the measurements can be advantageous, the state of the processed Part to be determined. It is possible by doing so, too to ensure proper use of a treated part. A defective part may be preferred during the treatment process be detected, sorted out or repaired. At the same time that can processed part based on its condition and possible defects classification, for example, for what purpose the part after processing should be provided. For example, its use on humans depending on the condition of the part excluded, but the use on Animal still allowed. Of course you can but also not yet used catheter systems of a plurality be subjected to measurements. This can be a flawless Treatment with the tested catheter system with a larger one Safety can be guaranteed.

Preferably, the catheter system is cleaned before and / or during and / or after the treatment process. In particular, in the case of a catheter system already in use, among other things, the prerequisites for the tests or the measurements of the catheter system and thus for the multiple use of the catheter system are created by the cleaning. A detailed optical examination of a catheter system can be carried out, for example, only when the catheter system has been cleaned of blood and / or contrast agent. A device and a method for cleaning already used catheter systems are described in the German patent application DE 102 09 993 A1 , for example, in column 3 ff described. The publication DE 102 09 993 A1 is hereby incorporated by reference and is to be considered part of this disclosure.

The crimping resistance and / or the compliance and / or the expansion pressure and / or the deflation time and / or the inflation time and / or the tightness and / or freedom from particles of a guide catheter and / or a balloon catheter are preferably tested in the treatment process. Furthermore, preference is given to an bioburden measurement and / or a cytotoxicity measurement and / or a chest compressure measurement and / or a hemocompatibility measurement and / or a detection of chemical and biological particles and / or a pyrogen measurement and / or a coating test carried out. Preferably, the guide catheter and / or the balloon catheter is sterilized and packaged at the end of the treatment process. By the measuring methods just described, a consistent quality of the processed part of a catheter system is ensured in an advantageous manner. Particularly preferably, potential hazards to patients due to a processed part can be excluded by the testing and measuring methods. For example, pathogens, with which the part was contaminated by the treatment on a patient, identifiable and destroyable in the further treatment process. Furthermore, it can be determined by the tests or measurements, whether the connections of the catheter system are tight, so that in the treatment can not unintentionally leak fluid from the catheter system. For the determination of the inflation time, it is preferable to measure the time required for a balloon to be inflated substantially to the specified diameter. The deflation time is preferably determined by measuring the time until the balloon has substantially completely collapsed after the inflation just described. The sterilization of the catheter system is preferably carried out by gas, for example by ethylene oxide and / or by autoclaving and / or by radiation, for example by radioactive radiation. Which method is used for sterilization depends essentially on the material properties of the catheter system to be sterilized. Prior to sterilization, the processed part is preferably dried, wherein, for example, an infrared drying can be used. It is understood that also optical measurements are made. For example, the guidewire can be examined microscopically, whereby a spiral on the guidewire, in particular, can be checked for damage and / or soiling. Of course, all measurements can also be carried out in at least part of a catheter system not yet used, wherein advantageously the perfect quality of the catheter systems is ensured by the measurements.

One Another object of the present invention is a treatment process for a balloon catheter, being used during treatment a balloon is smoothed. For a balloon catheter already in use, but also in a not yet used, new balloon catheter, by smoothing the balloon, the folding of the balloon, as already described, simplified and improved. Thus, you can also new, not yet used balloons exactly folded and in be fixed to their folding. This is the quality the balloon catheter, for example by improved dilatation of the balloon, increased.

Prefers The balloon catheter is a first and / or a second annealing process subjected. Particularly preferred is the balloon in the first annealing process smoothed, with the smoothing after the already described type done with the tempered sleeve. Farther Preferably, the balloon is folded after smoothing and The folds of the balloon then in a special Arrangement laid. The second tempering process preferably takes place hereafter. In the second tempering process, the balloon becomes with or without one Faltfixierung introduced into a tempered sleeve. In the case of using a Faltfixierung has the tempered sleeve in this case preferably a diameter which is slightly larger is as the balloon with the Faltfixierung. Now the balloon goes through Pressure widened, the folding of the balloon is fixed and smaller Creases, for example, by folding or laying the wrinkles are created are smoothed. In the case without the use of a Faltfixierung preferred the sleeve a diameter substantially equal to the diameter of the folded one Balloons corresponds. Preferably, the balloon is expanded with pressure, the folding of the balloon being pressed against the sleeve and thus fixed. Regarding the folding and laying and the fixation of the folds of the balloon is intended to the patent application with internal reference PY0012, filed on 3 May 2007, be referred to the German Patent and Trademark Office. This application is hereby introduced as a reference and is thus a Part of the revelation.

Preferably is in the treatment process, a first and / or a second Crimping procedure for attaching the stent performed on the balloon. Preferably, only the first crimping process takes place in the treatment process and then the second crimping process. Through the first crimping process the diameter of the stent is preferably reduced so that the Stent is slidably mounted on the balloon. For this purpose, the Stent preferably compressed by a crimping device. Before the second crimping process, the stent is readjusted on the balloon. In the second crimping process, the diameter then becomes of the stent so that the stent is fixed and substantially no longer slidably mounted on the balloon respectively is attached.

One Another object of the present invention is a catheter system, which was prepared according to the described treatment process.

The Recycled catheter system can be used for the introduction a stent can be used in the body of a living being. For example, the stent may be in the body of a human or an animal. Preferably, the Stent introduced into a hollow organ. A hollow organ for insertion the stent may be, for example, a coronary vessel, a carotid artery, a leg vessel, a cerebral vein, a renal vessel, a bile duct, a tear duct, a gullet or other part of the gastrointestinal tract, or even the cervix.

Another object of the present invention is a device for smoothing a balloon surface, wherein the device has a tempered sleeve has. The balloon is inserted within the device into the sleeve, the sleeve having a diameter that is minimally less than or equal to the fixed diameter of the balloon. If the balloon is then widened at least to the specified diameter, the balloon surface of the balloon is advantageously smoothed, since the balloon surface is pressed against the tempered sleeve. Such a device is manufactured for example by the company Fortimedix to produce a positive connection between a balloon and a stent after a crimping process, wherein in the device used hitherto, the sleeves are adapted in diameter to the folded balloon with the stent.

One Another object of the invention is a storage device for example for used catheter systems. In this Storage device may be the catheter systems used inserted essentially unscathed in the storage device be, wherein within the storage device a water vapor saturated Atmosphere prevails and / or the catheter systems essentially are covered with liquid. By the water vapor saturated Atmosphere can be advantageously prevented that contrast agent or blood, with which the catheter system during the treatment come in contact, dry. However, it is also conceivable that the storage device is designed so that already first processing steps take place automatically. For example the storage device may have a rinse tub, in which the catheter systems are placed in a solution and For example, can be pre-cleaned by ultrasonic waves. However, the treatment device is preferably transportable designed so that the catheter system in the treatment device for example, can be transported to the treatment process. Advantageously, by the storage device directly after using the catheter systems with a preparation for Processing be started. Of course that is Storage device also for other objects suitable. Preferably, however, for such articles, the to be treated and / or where the drying of Substances should be prevented. Regarding the design the storage device is to the patent application with the internal reference PY0014, filed on 03 May 2007, at German Patent and Trademark Office. The patent application is introduced as a reference and is therefore part of it Epiphany.

The Invention will be exemplified below with reference to a single figure described. The description restricts the general The idea of the invention is not one.

The single figure shows schematically a catheter system.

In the figure is schematically a catheter system 1 shown, wherein the catheter system 1 in the embodiment, a balloon catheter 2 and a guide catheter 7 having. The balloon catheter 2 includes in the embodiment a balloon 9 , a guidewire channel 4 , another channel 5 and a connection 6 , In the guidewire channel 4 is preferably a guide element 3 guided, for example, a guide wire. The connection 6 is preferably a Luer-Lock connection and preferably not made of polycarbonate. Through the connection 6 is the balloon catheter 2 preferably connected to a pump, wherein by means of the pump, a pressure for the deployment of the balloon 9 can be generated. Especially the areas 8th and 10 of the balloon catheter 2 are subject to special stress due to the repeated application and the treatment process. Therefore, these ranges are preferred 8th . 10 reinforced by the areas 8th . 10 For example, have metal mesh or double glued seams. The catheter system 1 also includes a lock 11 , The lock is preferred 11 into the leg artery 12 A patient is introduced so that blood does not flow unhindered from the previously opened leg artery 12 can flow. In the guide catheter 7 is preferred the balloon catheter 2 led, causing a violation of the leg artery 12 through the balloon catheter 2 can be excluded substantially.

1

catheter system

2

balloon catheter

3

guide element

4

Guidewire channel

5

Another channel

6

connection

7

guide catheter

8th

Area

9

balloon

10

Area

11

lock

12

artery

QUOTES INCLUDE IN THE DESCRIPTION

This list The documents listed by the applicant have been automated generated and is solely for better information recorded by the reader. The list is not part of the German Patent or utility model application. The DPMA takes over no liability for any errors or omissions.

Cited patent literature

• - DE 19532288 A1 [0002]
• - DE 10209993 A1 [0002, 0002, 0002, 0015, 0015]

Claims (16)

Catheter system ( 1 ) with a stent, characterized in that at least part of the catheter system ( 1 ) is processed. Catheter system ( 1 ) according to claim 1, characterized in that the catheter system ( 1 ) as part of at least one balloon catheter ( 2 ) and / or a guide catheter ( 7 ), wherein the balloon catheter ( 2 ) a smoothed balloon ( 9 ) having. Catheter system ( 1 ) according to one of the preceding claims, characterized in that the catheter system ( 1 ) a lock ( 11 ) and / or the balloon catheter ( 2 ) a guidewire channel ( 4 ) and / or another channel ( 5 ) and / or an integrated guide element and / or a pump and / or a guide element ( 3 ) and / or a connection ( 6 ) having. Catheter system ( 1 ) according to one of the preceding claims, characterized in that at least part of the catheter system ( 1 ) has a manufacturer identification as a characteristic. Catheter system ( 1 ) according to one of the preceding claims, characterized in that the indicator has information for preparation. Catheter system ( 1 ) according to one of the preceding claims, characterized in that the part of the catheter system ( 1 ) that has been prepared has specified minimum material thicknesses and / or material types and / or component sizes and / or component shapes and / or connections, whereby the part can be connected to devices in the treatment process and / or mechanical loads during processing and / or repeated use withstand. Balloon Catheter ( 2 ) with a stent for use in a catheter system ( 1 ) according to one of the preceding claims, characterized in that the balloon ( 9 ) of the balloon catheter ( 2 ) is folded and / or tempered. Preparation process for a catheter system ( 1 ) characterized in that the balloon catheter ( 2 ) and / or the guiding catheter ( 7 ) is subjected to a plurality of measurements during the conditioning process. Processing method according to claim 8, characterized in that the crimping resistance and / or the compliance and / or the expansion pressure and / or the deflation time and / or the inflation time and / or the tightness and / or the absence of particles is tested and / or a Bioburden Measurement and / or cytotoxicity measurement and / or breast pressure measurement and / or hemocompatibility measurement and / or detection of chemical and biological particles and / or pyrogen measurement and / or crossing profile measurement and / or a coating check is performed, the catheter system ( 1 ) is sterilized and packaged after the treatment process. Preparation process for a balloon catheter ( 2 ), characterized in that during the preparation of the balloon ( 9 ) of the balloon catheter ( 2 ) is smoothed. Processing method according to claim 10, characterized in that the balloon ( 9 ) of the balloon catheter ( 2 ) is subjected to a first annealing process and / or a second annealing process. Processing method according to at least one of claims 8 to 11, characterized in that a first crimping method and / or a second crimping method for fixing the stent on the balloon catheter ( 2 ) is carried out. Catheter system ( 1 ) obtainable by a treatment process according to any one of claims 8 to 12. Use of a catheter system ( 1 ) according to claim 13 for introducing a stent into the body of a living being. Device for smoothing a balloon surface of a balloon ( 9 ) of a balloon catheter ( 2 ), characterized in that the device comprises a tempered sleeve, wherein the diameter of the tempered sleeve is slightly smaller than or equal to a fixed diameter of the balloon ( 9 ), the balloon ( 9 ) in the device at least to the specified diameter is expandable and the surface of the balloon ( 9 ) is pressed in the device against the tempered sleeve, whereby the surface of the balloon ( 9 ) is smoothed. Storage device for a catheter system ( 1 ) according to claims 1 to 7, characterized in that an already used catheter system ( 1 ) is inserted into the storage device substantially without being bent, and within the storage device there is a water vapor-saturated atmosphere and / or the catheter system used is substantially covered with liquid, the drying of substances on or in the catheter system ( 1 ) is prevented.