WO2014072212A2

WO2014072212A2 - Protective sleeve, sealing and stripping element, closure cap and medical device system

Info

Publication number: WO2014072212A2
Application number: PCT/EP2013/072687
Authority: WO
Inventors: Andreas Hofmann; Elisabeth ALBERTINI
Original assignee: Biotronik AG
Current assignee: Biotronik AG
Priority date: 2012-11-12
Filing date: 2013-10-30
Publication date: 2014-05-15
Anticipated expiration: 2015-05-12
Also published as: WO2014072212A3

Abstract

A protective sleeve for an elongate medical device, in particular for a balloon catheter, for insertion into a vessel or organ of a living being, comprising an elongate sleeve body, which has a distal end and a proximal end and a continuous channel therebetween, wherein a flexible sealing and stripping element is attached at the proximal end and is designed to be adapted to the outer diameter of the medical device in such a way that the device is displaceable through the sealing and stripping element.

Description

PROTECTIVE SLEEVE, SEALING AND STRIPPING ELEMENT, CLOSURE CAP AND MEDICAL DEVICE SYSTEM

The present invention relates to a protective sleeve for an elongate medical device, in particular for a balloon catheter, for insertion into a vessel or organ of a living being and for removal therefrom, comprising an elongate sleeve body, which has a distal end and a proximal end and a continuous channel therebetween. The present invention further relates to a sealing and stripping element as well as a closure cap for forming such a protective sleeve, and to a medical device system, which comprises such a protective sleeve.

Introducers and protective sleeves for medical devices or components, such as catheters, electrode lines or stents, have long been known and used in a clinical environment. Whereas protective sleeves are used to protect such a device during delivery and storage until its intended use, introducers enable or facilitate the insertion into a vessel or organ of a living body, for example the insertion of a balloon catheter into a blood vessel for percutaneous transluminal coronary angioplasty (PTCA). Normally, a protective sleeve used as a transport sleeve has to be removed from the device before said device is used as intended, that is to say normally before the device can be inserted into the vessel or organ by means of the introducer.

Particular care and appropriate technical measures are advised when using medical devices of the aforementioned type, of which the surface is provided at least in part with a sensitive coating (for example an active ingredient coating). In this case, it is important to avoid a loss of the active ingredient, required at the treatment site, during the handling process as a result of removal, and also to prevent exposure of the clinical staff to the coating material where possible. It is therefore desirable to prevent a release of coating material as far as possible, both during the provision and insertion of a medical device of the aforementioned type into the body and during the removal thereof.

This objective is achieved by the protective sleeve described in EP 2 361 651 Al (in the name of the applicant), which can be fitted directly to an introducer or inserted therein and with which the mechanical stress placed on the used device during its provision and insertion is also reduced, such as contamination of the coating or exposure of the medical staff to coating material during the insertion process. Express reference is made to the definitions and explanations of functional relationships disclosed in the aforementioned document are referred for the following description of the present invention.

The object of the present invention is to disclose an improved protective sleeve of the above-mentioned type, which in particular further significantly reduces the exposure of the medical staff to coating material of a coating of the medical device.

This object is achieved by a protective sleeve having the features of claim 1. Expedient developments of the inventive concept are disclosed in the dependent claims. A sealing and stripping element as well as a closure cap for forming a protective sleeve of this type, and a medical device system comprising such a protective sleeve are further proposed.

The invention is based on the consideration of the inventors to prevent, where possible, the release of coating material of a device inserted into a body by means of an introducer, even after use of said device, that is to say once it has been removed from the body. The invention further includes the consideration of achieving this by means of a protective sleeve, of which the intended effect is implemented when the device is removed from the body, specifically when it is withdrawn from an introducer. Lastly, for this purpose, the invention includes the concept of providing a sealing and stripping element adapted to the geometrical design of the medical device. This element is to be designed such that the device can pass through the sealing and stripping element when withdrawn from the bodily vessel or organ, without the operator having to exert excessive force. In one embodiment of the invention, the sealing and stripping element is formed as a resiliently expandable tube, of which the diameter in the starting state is smaller than the outer diameter of the medical device. When in use, that is to say when the device (specifically the catheter) is retracted, the originally rolled-up or folded-back second part of the tube lies tightly around the periphery of the device and thus largely prevents any coating material remaining on the device after use from reaching the surrounding environment.

A further embodiment of the invention functions similarly, in which the sealing and stripping element is formed as a resiliently expandable tube, of which the diameter in the starting state is smaller than the outer diameter of the medical device and which sits over a first part of its length on the protective sleeve and is rolled up or folded back over a second part at the proximal end. In this case, the stripping effect is concentrated more or less over a narrow annular region (in the manner of a stripping edge). In this embodiment too, the fastening on the actual protective sleeve can be detached in a manner similar to that in the embodiment mentioned further above, specifically since the sealing and stripping element has a resiliently expandable tube portion, of which the diameter in the starting state is smaller than the outer diameter of the proximal end of the protective sleeve in such a way that the sealing and stripping element can be slid onto the proximal end of the protective sleeve, where it is held in place by means of the resilient pressure of the tube portion.

Instead of relying on a reliable fixing of the sealing and stripping element on the sleeve body by the resilient pressure of a tube portion or the like, a positive connection and/or integral bond may also be provided. In a further embodiment, the sealing and stripping element is thus fastened on the protective sleeve using adhesive or by means of a welded connection. Alternatively or in combination therewith, tube clips or similar fastening means and/or ring/annular groove designs, etc. can be used, or the proximal end of the sleeve body may have obtained an increased coefficient of friction for the sealing and stripping element or its fastening portion as a result of a ribbing or similar structuring.

In further embodiments of the invention, the tube or tube portion consists of silicone or a resilient thermoplastic elastomer. It is also possible for merely one resiliently deformable portion of the sealing and stripping element to consist of this material, whereas a further portion is fabricated from a substantially rigid plastics material. Besides the aforementioned resilient materials, other commercially available elastomers that are suitable for medical use (that is to say that can be sufficiently sterilized) can also be considered in principle for fabrication of the sealing and stripping element or a resilient ly deformable portion thereof.

In a further embodiment, the sealing and stripping element is formed integrally with the protective sleeve. Although the sealing and stripping element forms an integrally connected portion of the protective sleeve in this embodiment, it can be fabricated from the above-mentioned materials and may have the features explained above, provided these do not conflict with an integral design.

The material for the sleeve body, preferably a plastic, has to meet various demands. For example, it should preferably be weldable so as to ensure good processability. In addition, the material must be suitable for sterilization and/or disinfection using commercially available reagents and/or methods. Furthermore, the used material must have sufficient mechanical stability to protect the medical device effectively. HDPE is therefore preferably used for the sleeve body. However, polyamide or a polyamide block copolymer can also be used alternatively or in addition.

The protective sleeve according to the invention is designed as a disposable article for reasons of hygiene and practicability. However, it is also possible to re-use the protective sleeve after sterilization and disinfection with suitable selection of the material and form of said sleeve. If the sealing and stripping element is fabricated as a separate part and, for use, is connected to a sleeve body, likewise fabricated separately, both parts are preferably formed as disposable or single-use articles; it is also possible however to use a sealing and stripping element that is fabricated as a disposable article with a re-usable sleeve body.

In a further embodiment of the invention, the sealing and stripping element has a longitudinally continuous or spirally extending slit or a corresponding breaking point. If the sleeve body can also accordingly be formed separably, it is possible to remove the protective sleeve completely from the medical device (instrument) where necessary.

In a further embodiment, the inner surface of the main body of the sleeve body is provided with an anti-adhesive coating and/or with a coating lending sliding properties, which for example contains a compound from the group comprising PTFE (polytetrafluoroethylene) and silicone. The coating may cover the inner surface of the portion of the sealing and stripping element coming into contact with the medical device during the withdrawal process, although this is not necessarily the case. An advantage of the coating lies in the fact that the medical device and/or its coating cannot adhere to the inner surface of the protective sleeve during storage and transport. Furthermore, when the medical device is inserted into the introducer, it can slide therein or therethrough in an improved manner. A coating, which may or may not be provided on the medical device, thus remains intact until use.

In a further embodiment, the protective sleeve is additionally provided with a closure cap, which is provided at the distal end, closes said sleeve and has coupling means for connection to a protective wire or guide wire of the medical device. The closure cap can be removed by means of its fastening to the protective wire or guide wire when said wire is removed. In a specific design, the closure cap has a circumferential edge, which is fitted over the protective sleeve and which is designed to be adapted to an expanded distal end portion of the protective sleeve, in such a way that the closure cap sits via the circumferential edge on the protective sleeve, but can be removed therefrom against a resilient resistance.

The closure cap is an additional feature, which may additionally be provided.

The objective of the closure cap is to prevent active ingredient from exiting at the distal end of the protective sleeve before the intervention and thus from possibly endangering medical staff or the patient.

The closure cap is connected to the protective sleeve in the delivered state, but such that the medical staff can detach the closure cap from the protective sleeve with little effort. In addition, a wire could be connected to the closure cap. This wire would be slightly longer than the balloon region and would be introduced into the guide wire lumen. The closure cap (and wire if provided) would have to be removed by the medical staff before the intervention, that is to say before the device is inserted into the introducer.

In the system according to the invention, the medical device is protected by the protective sleeve after having been coated. In particular, the protective sleeve no longer has to be removed from the medical device by the user in order to handle the medical device. Instead, the protective sleeve itself is introduced in part into an introducer. The medical device is inserted into the introducer either from the protective sleeve or through the protective sleeve. It is also removed again from the patient's body through the protective sleeve when used as intended. In such a system, the device, that is to say a coated balloon catheter for example, is only subjected to a small extent to mechanical stresses such as friction or torsion. In particular, the coating, which for example contains a pharmaceutically active substance, is prevented in part from reaching the surrounding environment and from posing a possible health hazard to the clinical staff. Further advantages have already been explained above in conjunction with the protective sleeve according to the invention.

Advantages and expedient features of the invention will also emerge from the following description of exemplary embodiments on the basis of the figures, in which: shows a perspective illustration of an exemplary embodiment of the protective sleeve according to the invention,

Fig. 2 shows an illustration of the protective sleeve according to figure 1 , introduced into the end of an introducer.

Fig. 3 shows a schematic longitudinal sectional illustration of the protective sleeve according to figures 1 and 2 with the distal end of a balloon catheter received therein, Figs. 4A and 4B show schematic diagrams of a further embodiment of the protective sleeve according to the invention,

Fig. 5 shows a schematic diagram of a modified embodiment of the protective sleeve illustrated in figures 4A and 4B,

Fig. 6 shows a schematic diagram of a further embodiment of the protective sleeve according to the invention, and

Fig. 7 shows a schematic diagram (sectional view of the distal end) of an additional feature, which can be added to all previous exemplary embodiments of the protective sleeve according to the invention.

Figure 1 shows a protective sleeve 1 for a coated balloon catheter (not shown here), said protective sleeve having a substantially hollow cylindrical sleeve body 3 with a distal end 3a and a proximal end 3b. A stop element 5, which is likewise hollow cylindrical, sits on the sleeve body 3 close to the distal end, and a sealing and stripping element 7 is located at the proximal end 3b.

As can be seen in figure 2, which shows the protective sleeve 1 introduced into the end of an introducer 9, the stop element 5 defines full insertion of the protective sleeve into the introducer since its distal end face 5a contacts a proximal stop surface 1 lb of a lumen 11 of the introducer 9. The outer diameter of the stop element 5 is accordingly selected to be adapted to the inner diameter of the lumen 11, on the one hand in the wider proximal portion thereof and on the other hand in the narrower distal portion thereof.

A longitudinal slit 13 in the sleeve body 3, which continues as a slit portion 13a in the sealing and stripping element 7, makes it possible to remove the protective sleeve 1 from the shaft of a balloon catheter guided to and retracted again from the treatment site in said protective sleeve. Instead of a slit, a weakened line (breaking point) also extending in the longitudinal direction or else in a spiraled manner may also be provided in the wall of the sleeve body 3 and of the sealing and stripping element 7. The sleeve body 3 has an expansion portion (cone) 15 and 17 at its distal and proximal end respectively, of which the proximal cone 17 facilitates the sliding of the protective sleeve onto the balloon catheter during the production process and the distal cone 15 facilitates the retraction of the balloon catheter through the protective sleeve after use. Both functions can be envisaged on the basis of figure 3, which shows a balloon catheter 19 with a catheter body 21 and folded balloon 23 in the protective sleeve 1. This state is typical of the delivered state of the balloon catheter protected by the protective sleeve, and also of a typical end state after retraction of the balloon catheter into the protective sleeve after use.

The flexible sealing and stripping element 7 at the proximal end of the protective sleeve 1 is fabricated integrally with the protective sleeve in the embodiment shown in this instance, for example by being formed integrally with a smaller wall thickness than that of the sleeve body 3 and/or with a different (high-quality resilient) material. As already suggested by the term "sealing and stripping element", this element seals the protective sleeve 1 at the proximal end thereof with respect to the balloon catheter 19 and prevents an unintended release of material from a coating of the balloon 23 and also acts as a resilient stripper when the balloon catheter 19 is retracted in a proximal direction.

Figures 4A and 4B show schematic diagrams of a further exemplary embodiment of the invention, wherein reference numerals following those in figures 1 to 3 are used to denote like or functionally like parts or portions. The protective sleeve illustrated in this instance differs from the embodiment according to figures 1 to 3 primarily in that an integrally formed sealing and stripping element is not provided, but rather a highly resilient silicone tube 7' drawn over the proximal portion of the sleeve body 3 and the proximal cone 7. This tube sits on the proximal region of the sleeve body 3, secured against displacement by means of its shape-molding resilience and the pressure exerted thereby, and, with its overlying portion 7a', tightly surrounds the catheter body 21 of the balloon catheter 19 located in the protective sleeve in the usage position shown in figure 4A. When the balloon catheter is retracted proximally into the protective sleeve , the inner wall of the overlying portion 7a' strips the catheter body and, for example, strips any coating material still present, such that the silicone tube 7' acts as a sealing and stripping element. As an illustration of a possible delivered state, figure 4B shows how the overlaying portion 7a' in figure 4A is rolled back over the proximal cone 17 of the sleeve body 3, whereby, since there is no additional friction on the catheter during the introduction process, the balloon catheter can be easily fitted into the introducer without stripping any coating material from the balloon 23.

After use, that is to say before the catheter is retracted, the sealing and stripping element can be positioned selectively over the shaft of the catheter by being rolled back as in figure 4A. Any coating residues present on the catheter are largely held in the protective sleeve by means of this stripping function, and release into the surrounding environment is reduced considerably.

Figure 5 shows an embodiment of the proximal end of a protective sleeve 1A', which is modified compared to the exemplary embodiment according to figures 4A and 4B and in which (with otherwise identical construction) the silicone tube 7' is bonded integrally to the sleeve body 3 close to the proximal cone 17 via an adhesive layer or welded connection 25.

Figure 6 likewise schematically shows the proximal end of a further protective sleeve IB', over which a silicone tube 7B', designed differently compared to the embodiments according to figures 4 A to 5, is drawn as a sealing and stripping element. The part of said element overlying the proximal sleeve end with the cone 17 is shorter than in the above embodiments and surrounds the catheter body 21 of the balloon catheter located in the protective sleeve substantially merely by an (annular) sealing and stripping edge.

The diameter of the opening in this overlying portion can be easily adjusted by displacing the tube 7B' on the sleeve body, so that, for example as a result of displacement in a distal direction and a resultant enlargement of the opening, the balloon catheter can be inserted into the introducer without being stripped, whereas, if the balloon catheter is moved back in the proximal direction, a sealing and stripping effect is implemented as the catheter tube is retracted from the treatment site. Similarly to the embodiment according to figure 5, an integral bond between the silicone tube and the sleeve body may also be provided additionally in this case.

As a further exemplary embodiment, figure 7 shows, again in the form of a schematic diagram, a supplement to the above-described concept, which can be implemented in principle in all the above exemplary embodiments. The protective sleeve shown in figure 7 is therefore denoted by reference numeral 1 , but could also be denoted by numeral , 1A' or IB'. In addition to the balloon 23 of a balloon catheter, a protective wire or guide wire 25 is also illustrated in this instance, which is normally used with use of a balloon catheter. A closure cap 27 is slid over the distal end and over the cone 15 of the protective sleeve 1 provided there. This cap is connected or connectable to the protective wire or guide wire 25 at a connection point 27a and is therefore displaceable therewith. The closure cap 27 is held securely (although removably) on the protective sleeve by means of a circumferential edge 27b that is fitted over the cone 15 of the sleeve body 3. In specific phases of use, it prevents the undesired exit, beyond the protective sleeve 1, of coating material from the surface of the balloon 23.

The embodiment of the invention is not limited to the above-described examples and highlighted aspects, and a large number of modifications are also possible, which lie within the capabilities of a person skilled in the art.

Claims

Patent claims

1. A protective sleeve for an elongate medical device, in particular for a balloon catheter coated with an active ingredient, for insertion into a vessel or organ of a living being and for removal therefrom, comprising an elongate sleeve body, which has a distal end and a proximal end and a continuous channel therebetween, wherein a flexible sealing and stripping element is attached at the proximal end and is designed to be adapted to the outer diameter of the medical device in such a way that the device is displaceable through the sealing and stripping element.

2. The protective sleeve as claimed in claim 1, wherein the sealing and stripping element is formed as a resiliently expandable tube, of which the diameter in the starting state is smaller than the outer diameter of the medical device and which sits over a first part of its length on the protective sleeve and is rolled up or folded back over a second part at the proximal end.

3. The protective sleeve as claimed in claim 1, wherein the sealing and stripping element has an annular shape-molding and/or bending resilient covering portion with an opening, of which the diameter in the starting state is smaller than the outer diameter of the medical device.

4. The protective sleeve as claimed in claim 3, wherein the sealing and stripping element has a resiliently expandable tube portion, of which the diameter in the starting state is smaller than the outer diameter of the proximal end of the protective sleeve in such a way that the sealing and stripping element can be slid onto the proximal end of the protective sleeve, where it is held in place by means of the resilient pressure of the tube portion.

5. The protective sleeve as claimed in one of the preceding claims, wherein the tube or tube portion consists of silicone or a resilient thermoplastic elastomer.

6. The protective sleeve as claimed in one of the preceding claims, wherein the sealing and stripping element is fastened on the protective sleeve using adhesive or by means of a welded connection.

7. The protective sleeve as claimed in one of the preceding claims, wherein the sealing and stripping element has a longitudinally continuous or spirally extending slit or a corresponding breaking point.

8. The protective sleeve as claimed in one of claims 1, 3, 5 or 7, wherein the sealing and stripping element is formed integrally with the protective sleeve.

9. The protective sleeve as claimed in one of the preceding claims, comprising a closure cap, which is provided at the distal end, closes said protective sleeve and has coupling means for connection to a protective wire or guide wire of the medical device.

10. The protective sleeve as claimed in claim 9, wherein the closure cap has a circumferential edge, which is fitted over the protective sleeve and which is designed to be adapted to an expanded distal end portion of the protective sleeve, in such a way that the closure cap sits via the circumferential edge on the protective sleeve, but can be removed therefrom against a resilient resistance.

11. A sealing and stripping element for forming a protective sleeve as claimed in one of claims 1 to 7, 9 or 10.

12. A closure cap for forming a protective sleeve as claimed in claim 9 or 10.

13. A medical device system, comprising a protective sleeve as claimed in one of claims 1 to 10, in particular an elongate medical device that can be connected to the protective sleeve and can be inserted into a vessel or organ of a living being. The medical device system as claimed in claim 13, wherein the elongate medical device is formed as a balloon catheter or comprises such a catheter.